NICE research uncertainties are unanswered research questions that emerge during guidance development and published as research recommendations by NICE's research and development team. The recommendations are developed using the NICE research recommendations interim process and methods guide, which supports NICE guidance producers in making research recommendations (for example, from identifying uncertainties to prioritising research recommendations).

As NICE does not have an annual budget for primary research, it has close engagement and arrangements with the National Institute for Health Research (NIHR) to identify and address research priorities. The engagement is carried out through regular meetings on an annual cyclical basis.


Recommendation ID Recommendation Name Last Reviewed Date
CG113/1 What is the relative effectiveness of sertraline compared with cognitive behavioural therapy (CBT) in people with generalised anxiety disorder (GAD) that has not responded to guided self-help and psychoeducation in a stepped-care model? -
CG113/2 In well-defined generalised anxiety disorder (GAD), what is the clinical and cost effectiveness of two cognitive behavioural therapy (CBT) based low-intensity interventions (CCBT and guided bibliotherapy) compared with a waiting-list control? -
CG113/3 For people with generalised anxiety disorder (GAD) who are ready to start a low-intensity intervention, what is the clinical effectiveness of physical activity compared with waiting-list control? -
CG113/4 Is chamomile/ginkgo biloba more effective than placebo in increasing response and remission rates and decreasing anxiety ratings for people with generalised anxiety disorder (GAD)? -
CG113/5 What are the benefits of a primary care-based collaborative care approach to improving the treatment of generalised anxiety disorder (GAD) compared with usual care? -
CG113/6 In well-defined panic disorder, what is the clinical and cost effectiveness of two cognitive behavioural therapy (CBT) based low-intensity interventions (CCBT and guided bibliotherapy) compared with a waiting-list control? -
CG114/1 Intravenous iron in children:- A prospective study of adequate duration of intravenous iron preparations in children with anaemia of chronic kidney disease (CKD), including safety, dosing and efficacy outcomes. -
CG114/2 Trials of erythropoiesis-stimulating agents (ESAs) in children:- Trials of ESAs in children with anaemia of chronic kidney disease (CKD) (including darbepoetin, which is currently not licensed for use in children younger than 12 years) including safety, dosing and efficacy outcomes. -
CG114/3 Haemoglobin levels in older people:- An observational study of haemoglobin (Hb) levels and adverse outcomes in older people. -
CG114/4 Erythropoiesis-stimulating agent (ESA) tolerance test:- A trial of an ESA tolerance test including collection of data on ESA regimens and haemoglobin (Hb) levels achieved. -
CG114/5 Iron levels in pre-dialysis patients:- A randomised controlled trial to assess haemoglobin (Hb) level as an outcome in pre-dialysis patients treated to serum ferritin levels lower than 200 micrograms/l versus those treated to 300–500 micrograms/l. -
CG115/1 Is contingency management effective in reducing alcohol consumption in people who misuse alcohol compared with standard care? -
CG115/2 What methods are most effective for assessing and diagnosing the presence and severity of alcohol misuse in children and young people? -
CG115/3 Is acupuncture effective in reducing alcohol consumption compared with standard care? -
CG115/4 For which service users who are moderately and severely dependent on alcohol is an assertive community treatment model a clinically and cost-effective intervention compared with standard care? -
CG115/5 For people with moderate and severe alcohol dependence who have significant comorbid problems, is an intensive residential rehabilitation programme clinically and cost effective when compared with intensive community-based care? -
CG115/6 For people with alcohol dependence, which medication is most likely to improve adherence and thereby promote abstinence and prevent relapse? -
CG116/1 Prevalence and natural history of non-IgE-mediated food allergy:- How common are non-IgE-mediated food allergies in children and young people in primary care and community settings and when food allergies may be outgrown? -
CG116/2 Clinical predictors of non-IgE-mediated food allergy:- Which features in the clinical history best predict the presence of non-IgEmediated food allergy in children and young people in primary care and community settings? -
CG116/3 Information needs for children and young people:- during their care pathway to diagnosis of food allergy:- What do children and young people with IgE-mediated food allergy and their parents or carers want to know during the process of diagnosis and how is this demand best met? -
CG116/4 Values of skin prick testing and specific IgE antibody testing and their predictive value:- Can skin prick testing and specific IgE antibody testing cut-off points be established to diagnose IgE-mediated food allergy in children and young people, and to predict the severity of reaction? -
CG116/5 Modes of provision of support to healthcare professionals:- What would be the impact of dietetic telephone support to healthcare professionals to aid in the diagnosis and assessment of babies showing non-IgE-mediated food allergy symptoms in primary care and community settings? -
CG117/1 Interferon-gamma tests: - A diagnostic and qualitative study is needed to assess whether interferon-gamma tests are acceptable to patients and are more effective than tuberculin skin tests for:
• predicting subsequent development of active e tuberculosis (TB), or
• diagnosing or ruling out current active TB
when undertaking TB screening in:
• new entrants from high TB prevalence countries
• healthcare workers
• children in high-risk areas who missed neonatal Bl Bacille Calmette-Guèrin (BCG)
• contacts of people with sputum smear-positive TB
• HIV positive patients.
This study should compare the strategies of Mantoux test only, Mantoux test then interferon gamma test if positive, and interferon gamma test only.
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CG117/2 Directly observed therapy:- A cluster randomised controlled trial of directly observed therapy (DOT) compared with self-administered treatment for latent and/or active tuberculosis (TB) should be conducted in a UK population. This should be targeted at homeless people, and those with a history of non-adherence, alcoholism, drug abuse or mental illness. -
CG117/3 New entrant screening and treatment for latent tuberculosis (TB) infection:- A study is needed of people found by new entrant screening to be Mantoux positive and interferon-gamma positive, to establish better estimates of the cost effectiveness of screening and treatment for latent TB infection in this population. This could identify factors predisposing people to developing active TB so that more effective targeted treatment programmes can be developed for latent TB infection. -
CG117/4 Protective effects of Bacille Calmette-Guèrin (BCG):- A case-control study is needed, comparing people who developed active or latent tuberculosis (TB) with those who did not, and comparing the proportions of people in each group who had been vaccinated and the time since vaccination. The aim will be to derive improved estimates of protective efficacy and duration of protection of the BCG vaccine. -
CG117/5 Quality of life:- A study is needed to ascertain quality-of-life score estimates from those with tuberculosis (TB) (both active disease and latent infection), including adverse treatment effects, using an appropriate quality-of-life instrument. This will improve economic decision-making throughout TB care. -
CG117/6 Contact tracing in household contacts and homeless people:- Research is needed to determine whether contact tracing is more effective (in terms of identifying cases of latent infection and active disease) among household contacts than among street homeless contacts of patients with confirmed tuberculosis (TB) (including those using direct-access hostels for the homeless). -
CG117/7 Incentives for attending new entrant screening:- Research is needed to determine whether Port of Arrival scheme referrals with incentives for attending screening identify more cases of latent tuberculosis (TB) infection and active TB disease in new entrants than Port of Arrival scheme referrals with no incentives. -
CG117/8 Incentives for homeless people attending chest X-ray screening:- Research is needed to determine whether incentives for attending chest X-ray screening achieve better coverage in the homeless population, or identify more cases of latent tuberculosis (TB) infection and active TB disease, than no incentives. -
CG118/1 Surveillance programmes for people at increased risk of colorectal cancer:- How effective are colonoscopic surveillance programmes in improving overall survival and cancer-related survival in people at increased risk of colorectal cancer? -
CG118/2 Natural history of progression to colorectal cancer in people at increased risk:- What is the natural history of progression to colorectal cancer in people with inflammatory bowel disease (IBD) or adenomas? -
CG118/3 Effectiveness of biomarkers for determining level of risk of colorectal cancer:- Which biomarkers, including epigenic and genetic markers, are predictors of colorectal cancer? How should these be used to improve risk stratification? -
CG118/4 Adenoma types and risk of colorectal cancer:- Does the risk of colorectal cancer depend on the type of adenoma? -
CG119/1 Further research should be undertaken to determine the clinical and cost effectiveness of the following therapies; negative pressure wound therapy, total contact casting, hyperbaric oxygen therapy and surgical debridement for diabetic foot problems. -
CG119/2 What is the optimum wound-healing environment and what is the optimum dressing to treat diabetic foot ulcers? -
CG119/3 Does early revascularisation improve outcome in patients with diabetes and a foot ulcer? -
CG120/1 What are the prevalence, risk and protective factors, and course of illness for different combinations of psychosis and coexisting substance misuse (for example, schizophrenia and cannabis misuse or bipolar disorder and alcohol misuse)? -
CG120/10 What risk factors predict the onset of substance misuse in young people with psychosis? -
CG120/2 What and how should training be provided to healthcare professionals working with people with psychosis and substance misuse? -
CG120/3 Is providing treatment for psychosis and substance misuse services within staffed accommodation more cost-effective than a combination of hospital and home treatment? -
CG120/4 What service delivery models allow people with psychosis and coexisting substance misuse to remain living outside hospital? -
CG120/5 Are interventions for psychosis or substance misuse clinically and cost effective when compared with standard care for people with psychosis and coexisting substance misuse? -
CG120/6 Are psychosocial interventions clinically and cost effective when compared with standard care for people with psychosis and coexisting substance misuse? -
CG120/7 Are environmental interventions clinically and cost effective when compared with standard care for people with psychosis and coexisting substance misuse? -
CG120/8 Are interventions for psychosis or substance misuse clinically and cost effective when compared with standard care for people with psychosis and coexisting substance misuse? -
CG120/9 Is clozapine clinically and cost effective when compared with other pharmacological interventions for people with psychosis and coexisting substance misuse? -
CG121/1 Selection of patients with non-small-cell lung cancer (NSCLC) for treatment with curative intent:- Further studies should be performed into factors that predict successful outcome of treatment with curative intent. Studies should include fitness parameters and functional imaging. -
CG121/2 Effectiveness of surgery with or without multimodality treatment in N2 disease:- Patients with non-bulky single zone N2 disease should be considered for trials of surgery with or without multimodality treatment. Outcomes should include mortality and 5-year survival. -
CG121/3 Pulmonary rehabilitation, optimisation of drug treatment and enhanced recovery programmes:- Research should be undertaken into the benefits of pulmonary rehabilitation, optimisation of drug treatment and enhanced recovery programmes before and after surgery. Outcomes should include mortality, survival, pulmonary complications, pulmonary function and quality of life (including assessment by EQ-5D). -
CG121/4 New regimens for radiotherapy with curative intent:- Research should be considered into dose escalation in radiotherapy with curative intent, including stereotactic body irradiation (SBRT). Outcomes should include mortality, pulmonary complications, pulmonary function and validated quality of life measures (including assessment by EQ-5D). -
CG121/5 Imaging modalities for monitoring response and recurrent disease:- Randomised controlled trials should be conducted to examine the value of imaging modalities and other interventions in the monitoring of response and recurrent disease. -
CG122/1 Relationship between duration of symptoms of ovarian cancer and stage at diagnosis:- Further research should be undertaken on the relationship between the duration and frequency of symptoms in women with ovarian cancer before diagnosis, the stage of disease at diagnosis and subsequent survival. -
CG122/2 RMI I (risk of malignancy index I) threshold for women with suspected ovarian cancer:- Further research should be undertaken to determine the optimum RMI I threshold that should be applied in secondary care to guide the management of women with suspected ovarian cancer. -
CG122/3 Imaging in the diagnostic pathway for women with ovarian cancer:- Large multicentre case–control studies should be conducted to compare the accuracy of CT versus MRI for staging and for predicting optimal cytoreduction in women with ovarian cancer. -
CG122/4 The role of systematic retroperitoneal lymphadenectomy in the surgical treatment of ovarian cancer:- A prospective randomised trial should be undertaken to evaluate the therapeutic effect, associated risks and cost effectiveness of systematic retroperitoneal lymphadenectomy in women with ovarian cancer whose disease appears to be confined to the ovaries. -
CG122/5 The value of primary surgery for women with advanced ovarian cancer:- Research should be undertaken to determine the effectiveness of primary surgery for women with advanced ovarian cancer whose tumour cannot be fully excised. -
CG123/1 Comprehensive assessment versus a brief assessment:- For people with a suspected common mental health disorder, what is the clinical and cost effectiveness of using a comprehensive assessment (conducted by mental health professional) versus a brief assessment (conducted by a paraprofessional)? -
CG123/2 'Walking across’ from one assessment instrument to another:- What methodology should be used to allow ‘walking across’ from one assessment instrument for common mental health disorders to another? -
CG123/3 Generalized Anxiety Disorder scale (GAD-2) for people with suspected anxiety disorders:- In people with suspected anxiety disorders, what is the clinical utility of using the GAD-2 compared with routine case identification to accurately identify different anxiety disorders? Should an avoidance question be added to improve case identification? -
CG123/4 Routine outcome measurement:- In people with a common mental health disorder, what is the clinical utility of routine outcome measurement and is it cost effective compared with standard care? -
CG123/5 Use of a simple algorithm compared with a standard clinical assessment:- For people with a common mental health disorder, is the use of a simple algorithm (based on factors associated with treatment response), when compared with a standard clinical assessment, more clinically and cost effective? -
CG123/6 Priority of treatment for people with anxiety and depression:- For people with both anxiety and depression, which disorder should be treated first to improve their outcomes? -
CG124/1 Imaging options in occult hip fracture:- In patients with a continuing suspicion of a hip fracture but whose radiographs are normal, what is the clinical and cost effectiveness of computed tomography (CT) compared to magnetic resonance imaging (MRI), in confirming or excluding the fracture? -
CG124/2 Anaesthesia:- What is the clinical and cost effectiveness of regional versus general anaesthesia on postoperative morbidity in patients with hip fracture? -
CG124/3 Displaced intracapsular hip fractures:- What is the clinical and cost effectiveness of large-head total hip replacement versus hemiarthroplasty on functional status, reoperations and quality of life in patients with displaced intracapsular hip fracture? -
CG124/4 Intensive rehabilitation therapies after hip fracture:- What is the clinical and cost effectiveness of additional intensive physiotherapy and/or occupational therapy (for example progressive resistance training) after hip fracture? -
CG124/5 Early supported discharge in care home patients:- What is the clinical and cost effectiveness of early supported discharge on mortality, quality of life and functional status in patients with hip fracture who are admitted from a care home? -
CG125/1 Process of decision-making:- How should the process of decision-making about the choice of dialysis modality, including peritoneal dialysis, be supported? -
CG125/2 Effectiveness of modality:- What factors determine the effectiveness of any modality of dialysis, including peritoneal dialysis? -
CG125/3 Treatment sequence:- What is the most effective sequence of treatment? -
CG125/4 Nutritional status:- Is there any significant difference in nutritional status between people on the different dialysis treatment modalities? -
CG125/5 Evaluating effectiveness:- Which outcomes should be used in evaluating effectiveness? -
CG126/1 Adding a newer anti-anginal drug to a calcium channel blocker:- What is the clinical and cost effectiveness of adding a newer anti-anginal drug (nicorandil, ivabradine or ranolazine) to a calcium channel blocker for treating stable angina? -
CG126/2 Management of stable angina in people with evidence of ischaemia on non-invasive functional testing:- Do people with stable angina and evidence of reversible ischaemia on noninvasive functional testing who are on optimal drug treatment benefit from routine coronary angiography with a view to revascularisation? -
CG126/3 Early revascularisation strategy for people with angina and multivessel disease:- In people with stable angina and multivessel disease (including left main stem disease) whose symptoms are controlled with optimal drug treatment, would an initial treatment strategy of revascularisation be clinically and cost effective compared with continued drug treatment? -
CG126/4 Cardiac rehabilitation:- Is an 8-week, comprehensive, multidisciplinary, cardiac rehabilitation service
more clinically and cost effective for managing stable angina than current clinical practice?
-
CG126/5 Patient self-management plans:- What is the clinical and cost effectiveness of a self-management plan for people with stable angina? -
CG127/1 Out-of-office monitoring: In adults with primary hypertension, does the use of out-of-office monitoring (home blood pressure monitoring-HBPM or ambulatory blood pressure monitoring-ABPM) improve response to treatment? -
CG127/2 Intervention thresholds for people aged under 40 with hypertension In people aged under 40 years with hypertension, what are the appropriate thresholds for intervention? -
CG127/3 Methods of assessing lifetime cardiovascular risk in people aged under 40 years with hypertension:- In people aged under 40 years with hypertension, what is the most accurate method of assessing the lifetime risk of cardiovascular events and the impact of therapeutic intervention on this risk? -
CG127/4 Optimal systolic blood pressure: - In people with treated hypertension, what is the optimal systolic blood pressure? -
CG127/5 Step 4 antihypertensive treatment:- In adults with hypertension, which drug treatment (diuretic therapy versus other step 4 treatments) is the most clinically and cost effective for step 4 antihypertensive treatment? -
CG127/6 Automated blood pressure monitoring in people with atrial fibrillation: - Which automated blood pressure monitors are suitable for people with hypertension and atrial fibrillation? -
CG128/1 Training professionals:- Does training professionals to recognise signs and symptoms of autism lead to earlier assessment of needs and earlier diagnosis (and by implication reduce morbidity/improve health outcomes) among children and young people with suspected autism compared with no training? -
CG128/2 Gathering information in schools or nurseries:- Does routine additional information from educational settings (such as nursery or school) improve accuracy in diagnosing autism among children or young people up to the age of 19 compared with signs and symptoms alone? -
CG128/3 Additional assessments:- Do additional assessments (for IQ, language ability and motor ability) improve accuracy in diagnosing autism among preschool children (younger than 5 years) compared with signs and symptoms alone? -
CG128/4 Comparative genomic hybridisation array:- What is the effectiveness and acceptability of comparative genomic hybridisation (CGH) array compared with current genetic testing in children and young people with identified autism? -
CG129/1 Information and emotional support:- Does additional information and emotional support improve outcomes in twin and triplet pregnancies? -
CG129/2 Specialist care:- Does specialist antenatal care for women with twin and triplet pregnancies improve outcomes for women and their babies? -
CG129/3 Monitoring for intrauterine growth restriction:- What is the pattern of fetal growth in healthy twin and triplet pregnancies, and how should intrauterine growth restriction be defined in twin and triplet pregnancies? -
CG129/4 Preventing preterm birth:- What interventions are effective in preventing spontaneous preterm birth in women with twin and triplet pregnancies, especially in those at high risk of preterm birth? -
CG129/5 Indications for referral to a tertiary level fetal medicine centre:- What is the incidence of monochorionic monoamniotic twin and triplet pregnancies, and what clinical management strategies are most effective in such pregnancies? -
CG129/6 Timing of birth:- What is the incidence of perinatal and neonatal morbidity and mortality in babies born by elective birth in twin and triplet pregnancies? -
CG130/1 Optimal management of hyperglycaemia in acute coronary syndromes (ACS): What is the optimal management of hyperglycaemia in people with acute coronary syndrome who have diagnosed or previously undiagnosed diabetes? -
CG131/1 Treatment of patients with moderate-risk locally advanced rectal cancer:- The effectiveness of preoperative chemotherapy should be compared with short-course preoperative radiotherapy (SCPRT), chemoradiotherapy or surgery alone in patients with moderate-risk locally advanced rectal cancer. Outcomes of interest are local control, toxicity, overall survival, quality of life and cost effectiveness. 06/01/2015
CG131/2 The value of prognostic factors in guiding optimal management in patients with locally excised, pathologically confirmed stage I cancer:- An observational study should be conducted, incorporating standardised assessment of pathological prognostic factors, to assess the value of the proposed prognostic factors in guiding optimal management in patients with locally excised, pathologically confirmed stage I cancer. Outcomes of interest are disease-free survival, overall survival, local and regional control, toxicity, cost effectiveness and quality of life. 06/01/2015
CG131/3 The most effective sequence to perform magnetic resonance imaging (MRI and PET-CT in patients with colorectal cancer metastasised to the liver to determine whether the metastasis is resectable:- A prospective trial should be conducted to investigate the most clinically-effective and cost-effective sequence in which to perform MRI and PET-CT, after an initial CT scan, in patients with colorectal cancer that has metastasised to the liver, to determine whether the metastasis is resectable. The outcomes of interest are reduction in inappropriate laparotomies and improvement in overall survival. 06/01/2015
CG131/4 Follow-up after completion of oncological treatment:- Strategies to integrate oncological surveillance with optimising quality of life, reducing late effects, and detecting second cancers in survivors of colorectal cancer should be developed and explored. 06/01/2015
CG131/5 Patient-reported outcome measures in colorectal cancer:- Colorectal cancer-specific patient-reported outcome measures (PROMs) should be developed for use in disease management and to inform outcome measures in future clinical trials. 06/01/2015
CG132/1 Decision-to-delivery interval (category 1 urgency):- What factors influence the decision-to-delivery interval when there is a category 1 level of urgency for Caesarean Section (CS)?
Factors to be investigated could include:
• staff grade/level of experience
• skill mix in the multidisciplinary team
• task allocation
• methods of communication
• time of day
• availability of ongoing staff training about emergency procedures and levels of attendance.
The research could be conducted using simulation methods and video observation to determine what factors influence the decision-to-delivery interval for category 1 CS. The videos could also be used to train staff.
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CG132/10 Women should be informed that the effects on the likelihood of Caesarean Section (CS) of complementary therapies used during labour (such as acupuncture, aromatherapy, hypnosis, herbal products, nutritional supplements, homeopathic medicines, and Chinese medicines) have not been properly evaluated and further research is needed before such interventions can be recommended. [2004] -
CG132/11 The effectiveness and safety of single layer closure of the uterine incision is uncertain. Except within a research context, the uterine incision should be sutured with two layers. [2004] -
CG132/2 Decision-to-delivery interval (category 2 urgency):- A prospective study to determine whether the decision-to-delivery interval has an impact on maternal and neonatal outcomes when there is a category 2 level of urgency for Caesarean Section (CS).
Important primary outcomes would be:
• fetal wellbeing (such as cord blood gases, Apgar score at 5 minutes, hypoxic encephalopathy, neonatal respiratory problems, unanticipated admission to neonatal intensive care unit (NICU), duration of stay in the NICU) maternal wellbeing (such as haemoglobin levels on day 2, need for blood transfusion, duration of hospital stay controlled for prolonged neonatal stay and general health/wellbeing).
Valuable secondary outcomes could include:
• fetal trauma at delivery
• iatrogenic maternal bladder or bowel injury
• postoperative maternal infectious morbidity
• establishment of breastfeeding
• psychological outcomes for women, such as the development of postnatal depression/posttraumatic stress disorder.
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CG132/3 National audit:- Repeat of the National Caesarean Section Sentinel Audit. The original Caesarean Section (CS) guideline included a set of 'auditable standards'. It would be a straightforward task to produce an updated set of auditable standards based on the important topics covered in the updated guideline. These could include:
• consent
• indications (including maternal request)
• procedural aspects
• maternal and fetal outcomes.
Many of the outcomes documented in a new CS audit would relate directly to recommendations in this CS guideline update. Researchers may also want to consider categorising different reasons underlying maternal request for CS such as previous poor childbirth experience, longstanding fear of childbirth, belief that CS is safer for the baby etc.
An additional useful feature of the audit would be to record key related data, such as the proportion of CS deliveries for a breech presentation that had an attempted external cephalic version.
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CG132/4 Maternal request for Casarean Section (CS): What support or psychological interventions would be appropriate for women who have a fear of vaginal childbirth and request a CS?
Interventions for evaluation could include:
• support from a named member of the maternity team
• continuity of carer
• formal counselling
• cognitive behavioural therapy.
Outcomes could include:
• mode of birth planned at term
• psychological outcomes (postnatal depression, post-traumatic stress disorder, self-esteem, mother–infant bonding)
• breastfeeding.
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CG132/5 Risks and benefits of Caesarean Section (CS): What are the medium- to long-term risks and benefits to women and their babies of planned CS compared with planned vaginal birth? The main focus would be the outcomes in women, which could be measured at 1 year (medium term) and 5–10 years (long term). These outcomes could include:
• urinary dysfunction
• gastrointestinal dysfunction
• dyspareunia
• breastfeeding
• psychological health.
Infant outcomes could include medical problems, especially ongoing respiratory and neurological problems.
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CG132/6 In otherwise uncomplicated twin pregnancies at term where the presentation of the first twin is cephalic, perinatal morbidity and mortality is increased for the second twin. However, the effect of planned Caesarean Section (CS) in improving outcome for the second twin remains uncertain and therefore CS should not routinely be offered outside a research context. [2004] -
CG132/7 Preterm birth is associated with higher neonatal morbidity and mortality. However, the effect of planned Caesarean Section (CS) in improving these outcomes remains uncertain and therefore CS should not routinely be offered outside a research context. [2004] -
CG132/8 The risk of neonatal morbidity and mortality is higher with 'small for gestational age' babies. However, the effect of planned Caesarean Section (CS) in improving these outcomes remains uncertain and therefore CS should not routinely be offered outside a research context. [2004] -
CG132/9 Pregnant women with a recurrence of herpes simplex virus (HSV) at birth should be informed that there is uncertainty about the effect of planned Caesarean Section (CS) in reducing the risk of neonatal HSV infection. Therefore, CS should not routinely be offered outside a research context. [2004] -
CG133/1 Effectiveness of training:- For healthcare professionals who work with people who self-harm, does the provision of training in assessment and management improve outcomes compared with no additional specialist training?
A well-powered randomised controlled trial should examine the effectiveness of training. Researchers should consider the format and length of training. The outcomes chosen should include both healthcare professionals' and service users' evaluation of the training, and the effect on subsequent knowledge, attitude and behavioural changes. It should include longer-term follow-up of 12 months or more.
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CG133/2 Effectiveness of psychosocial assessment with a valid risk scale:- For people who self-harm (including young people), does the provision of psychosocial assessment with a validated risk scale, compared with psychosocial assessment alone, improve outcomes?
This question should be answered using a well-conducted randomised controlled trial. The assessment should be conducted by mental health professionals in community mental health teams. The main outcomes should include both hospital-reported and self-reported repetitions of self-harm. Outcomes such as service users' experience of assessment and the impact on therapeutic engagement should also be included. The duration of the study should be at least 6 months.
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CG133/3 Clinical and cost effectiveness of psychological therapy:- with problem-solving elements for people who self-harm:- For people who have self-harmed, does the provision of a psychological therapy with problemsolving elements, compared with treatment as usual, improve outcomes? What is the differential effect for people with a past history of self-harm, compared with people who self-harm for the first time? This question should be answered using a well-conducted randomised controlled trial. Consider six sessions of psychological therapy with problem-solving elements, delivered immediately after discharge for the index episode of self-harm. The therapist should be trained and experienced in working with people who self-harm. Participants' history of previous self-harm, methods used and psychiatric history should be noted. Primary outcomes should include both hospital-reported and self-reported repetitions of self-harm. Other important outcomes, such as quality of life, depressive symptoms, service users' experience and adverse events (for example, distress or exacerbation of symptoms associated with therapy) should be included. The study design should take into account the complex motives that underpin self-harm. Studies need to be large enough to determine the intervention's costs and cost effectiveness. -
CG133/4 Clinical effectiveness of low-intensity/brief psychosocial interventions for people who self-harm:- For people who self-harm, does the provision of potentially cheap low-intensity/brief psychosocial interventions, compared with treatment as usual, improve outcomes? This question should be answered using a well-conducted randomised controlled trial. Consider using a variety of approaches, including postcards, emergency cards, phone calls, or the use of electronic media in community mental health settings. The outcomes should include service users' engagement and experience, and hospital-reported and self-reported repetitions of self harm. Other important outcomes, such as quality of life, depressive symptoms and adverse events (for example, distress or exacerbation of symptoms associated with contact with services) should be included. -
CG133/5 Observational study exploring different harm-reduction approaches:- What are the different approaches to harm reduction following self-harm in NHS settings?
A study should be carried out to investigate the different approaches to harm reduction following self-harm currently in use in NHS settings. This could use survey methodology with all, or a selected sample of, mental health service providers. Audit data should be used to provide a preliminary evaluation of potential utility. Promising interventions might be tested in small-scale pilot randomised controlled trials, which use frequency and severity of self-harm, and standard measures of distress and psychological symptoms, as outcome measures. Other outcomes such as quality of life, service users' experience and adverse events should be included.
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CG134/1 Mediators of anaphylactic reactions:- Aside from mast cell tryptase, which other chemical inflammatory mediators offer potential as indicators of anaphylaxis? -
CG134/2 The frequency and effects of biphasic reactions:- What are the frequency, timing, severity and predictors of biphasic reactions in people who have received emergency treatment for anaphylaxis? -
CG134/3 Length of observation period following emergency treatment for anaphylaxis:- For how long should a person who has received emergency treatment for anaphylaxis be observed? -
CG134/4 Prevalence of anaphylactic reactions and related outcomes:- What is the annual incidence of anaphylaxis and its related outcomes within the UK? -
CG134/5 Effect of specialist services on health-related quality of life:- For people who have experienced suspected anaphylaxis, what is the effect on health-related quality of life of (a) referral to specialist allergy services and (b) provision of adrenaline injectors, when compared with emergency treatment alone? -
CG135/1 Joining the NHS organ donation register:- What are the factors and processes that would encourage the general public to sign up on the UK NHS organ donor register (ODR)? -
CG135/2 Reasons for refusal for consent:- Why do families refuse to give permission for organ donation? -
CG135/3 Improving rates of identification and referral of potential donors:- What are the key components of an intervention to improve identification and referral rates? -
CG135/4 Improving consent rates:- What are the key components of an intervention to improve consent rates? -
CG135/5 The experience of consenting for organ donation:- Does a positive experience of approach and process of consent for families increase consent rates? -
CG136/1 Training in the use of the national quality standard and guidance on service user experience of care:- For people using adult mental health services, what is the effect of training community mental health teams (CMHTs) and inpatient ward staff in the use of the national quality standard and underpinning guidance on service user experience, when compared to no training, on service
users' experience of care?
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CG136/2 Late access to services and compulsory and intensive treatment:- For people using adult mental health services, what are the personal and demographic factors associated with late access to services and an increased likelihood of compulsory and intensive treatment, and what are the key themes that are associated with poor engagement? This should include an examination of factors that impact on access to services among younger people and older adults. -
CG136/3 Shared decision-making:- For people using adult mental health services, what are the key aspects of 'shared decision-making' that they prefer, and does a training programme for health and social care professionals designed around these key aspects, when compared with no training, improve service users' experience of care? A study should be undertaken to evaluate the impact on treatment choice, the experience of care and treatment effectiveness of training service users to deal with health and social care professionals assertively. -
CG136/4 Activities and occupations on inpatient wards:- For people receiving adult mental health hospital care, what activities and occupations do service users want when staying on inpatient wards? -
CG136/5 Compulsion, control and restraint:- For people using adult mental health services, how is compulsory treatment and 'control and restraint' used in different settings and what is the impact on the service user? -
CG137/1 Newly diagnosed seizures (focal and generalised) – monotherapy: How do the newer AEDs compare in efficacy to the standard anti-epileptic drugs (AEDs) in the treatment of newly diagnosed epilepsy?
- Focal seizures: carbamazepine, eslicarbazepine acetate, lacosamide, lamotrigine, levetiracetam, pregabalin and zonisamide.
- Generalised seizures: lamotrigine, levetiracetam, sodium valproate and zonisamide.
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CG137/2 Epilepsy syndromes:- What are the initial and add-on anti-epileptic drugs (AEDs) of choice in the treatment of the epilepsy syndromes with onset in childhood, for example, myoclonic-astatic epilepsy and Dravet syndrome? -
CG137/3 Infantile spasms:- Does treatment response relate to cause in infantile spasms? Does early treatment success in seizure control and resolution of the hypsarrhythmic electroencephalogram (EEG) influence the long-term developmental and cognitive outcomes more than the underlying cause of the spasms? -
CG137/4 Treatment of convulsive status epilepticus (that is, not just refractory):- What is the most effective and safest anti-epileptic drugs (AED) to treat:
- established (usually lasting longer than 30 minutes) convulsive status epilepticus
- refractory convulsive status epilepticus?
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CG137/5 Anti-epileptic drugs (AEDs) and pregnancy:- What is the malformation rate and longer term neurodevelopmental outcome of children born to mothers who have taken AEDs during pregnancy? -
CG139/1 Standard principles of infection prevention and control:- What are the barriers to compliance with the standard principles of infection prevention and control that patients and carers experience in their own homes? -
CG139/2 Hand decontamination:- When clean running water is not available, what is the clinical and cost effectiveness of using wipes, gels, handrubs or other products to remove visible contamination? -
CG139/3 Intermittent urinary catheters: catheter selection:- For patients performing intermittent self-catheterisation over the long term, what is the clinical and cost effectiveness of single-use non-coated versus single-use hydrophilic versus single-use gel reservoir versus reusable non-coated catheters with regard to the following outcomes: symptomatic urinary tract infections, urinary tract infection-associated bacteraemia, mortality, patient comfort and preference, quality of life, and clinical symptoms of urethral damage? -
CG139/4 Indwelling urinary catheters: catheter selection:- For patients using a long-term indwelling urinary catheter, what is the clinical and cost effectiveness of impregnated versus hydrophilic versus silicone catheters in reducing symptomatic urinary tract infections, encrustations and/or blockages? -
CG139/5 Indwelling urinary catheters: antibiotic prophylaxis:- When recatheterising patients who have a long-term indwelling urinary catheter, what is the clinical and cost effectiveness of single-dose antibiotic prophylaxis in reducing symptomatic urinary tract infections in patients with a history of urinary tract infections associated with catheter change? -
CG139/6 Vascular access devices: skin decontamination:- What is the clinical and cost effectiveness of 2% chlorhexidine in alcohol versus 0.5% chlorhexidine in alcohol versus 2% chlorhexidine aqueous solution versus 0.5% chlorhexidine aqueous solution for cleansing skin (before insertion of peripheral vascular access devices [VADs] and during dressing changes of all VADs) in reducing VAD-related bacteraemia and VAD site infections? -
CG140/1 Communication:- What are the most clinically effective and cost-effective methods of addressing patient and carer concerns about strong opioids, including anticipating and managing adverse effects, and engaging patients in prescribing decisions? 24/05/2012
CG140/2 Side effects:- Is prophylactic prescription of anti-emetic treatment or availability of anti-emetic treatment at the patient's home more effective in reducing nausea than the availability of prescription on request for patients starting strong opioids for the treatment of pain in advanced or progressive disease? The outcomes of interest are nausea, time to control of nausea, patient acceptability of treatment, concordance and use of healthcare resources. 24/05/2012
CG140/3 Side effects:- Is early switching of opioid, on development of side effects, more effective at reducing central side effects than persisting with current opioid and dose reduction in patients starting strong opioids? The outcomes of interest are time to clinically effective pain control with acceptable side effects. 24/05/2012
CG142/1 Facilitated self-help for anxiety and depression in adults with autism:- What is the clinical and cost effectiveness of facilitated self-help for the treatment of mild anxiety and depressive disorders in adults with autism? 09/07/2012
CG142/2 Cognitive behavioural therapy (CBT) for anxiety disorders in adults with autism:- What is the clinical and cost effectiveness of CBT for the treatment of moderate and severe anxiety disorders in adults with autism? 09/07/2012
CG142/3 Pharmacological treatments for depression in adults with autism:- What is the clinical and cost effectiveness of selective serotonin reuptake inhibitors (SSRIs) for the treatment of moderate and severe depression in adults with autism? 09/07/2012
CG142/4 The structure and organisation of specialist teams:- What structure and organisation of specialist autism teams are associated with improvements in care for people with autism? 09/07/2012
CG142/5 Augmentative communication devices for adults with autism:- What is the clinical and cost effectiveness of augmentative communication devices for adults with autism? 09/07/2012
CG143/1 Pain management for patients with an acute painful sickle cell episode:- For patients with an acute painful sickle cell episode, what are the effects of different opioid formulations, adjunct pain therapies and routes of administration on pain relief and acute sickle cell complications? 10/07/2012
CG143/2 Use of low-molecular-weight heparin to treat patients with an acute painful sickle cell episode:- Are therapeutic doses of low-molecular-weight heparin (LMWH) effective, compared with prophylactic doses of LMWH, in reducing the length of stay in hospital of patients with an acute painful sickle cell episode? 10/07/2012
CG143/3 Psychological interventions for patients with an acute painful sickle cell episode:- For patients with an acute painful sickle cell episode, are psychological interventions, in conjunction with standard care, effective in providing pain relief? 10/07/2012
CG143/4 Non-pharmacological interventions for patients with an acute painful sickle cell episode:- For patients with an acute painful sickle cell episode, are non-pharmacological interventions, such as massage, effective in improving their recovery from the episode? 10/07/2012
CG143/5 Cost effectiveness of daycare units for treating patients with an acute painful sickle cell episode:- Are daycare units cost effective compared with emergency settings for treating patients with an
acute painful sickle cell episode?
10/07/2012
CG144/1 Diagnosis of deep vein thrombosis:- What is the clinical and cost effectiveness of a whole-leg ultrasound scan compared with a proximal leg vein ultrasound scan in the diagnosis of acute deep vein thrombosis (DVT)? 10/07/2012
CG144/2 Long-term versus 3-month oral anticoagulation treatment in subgroups of patients at increased risk of VTE recurrence:- What is the clinical and cost effectiveness of long-term oral anticoagulation treatment in specific subgroups of patients with a first unprovoked VTE? 10/07/2012
CG144/3 Long-term anticoagulation treatment with low molecular weight heparin versus a vitamin K antagonist in patients with VTE and active cancer:- In patients with VTE and active cancer who have had 6 months of anticoagulation treatment with low molecular weight heparin (LMWH), what is the clinical benefit (in terms of VTE recurrence rates, all-cause mortality and major bleeding) and cost effectiveness of continued anticoagulation treatment with LMWH versus a vitamin K antagonist (VKA)? 10/07/2012
CG144/4 Thrombolytic therapy for DVT:- What is the clinical and cost effectiveness of clot removal using catheter-directed thrombolytic therapy or pharmacomechanical thrombolysis compared with standard anticoagulation therapy for the treatment of acute proximal DVT? 10/07/2012
CG144/5 Systemic pharmacological thrombolysis compared with standard anticoagulation treatment in patients with pulmonary embolism and right ventricular dysfunction:- What is the clinical and cost effectiveness of systemic pharmacological thrombolysis compared with standard initial anticoagulation therapy in patients with confirmed PE and haemodynamic stability who present with right ventricular dysfunction? 10/07/2012
CG145/1 Inhibitors of functional ability:- What are the greatest inhibitors of functional ability in children and young people with upper motor neurone lesions? 30/08/2012
CG145/2 Postural management:- What is the optimal postural management programme using a standing frame in children aged 1–3 years? 30/08/2012
CG145/3 Botulinum toxin type A:- What is the clinical and cost effectiveness of botulinum toxin type A when used routinely or according to clinical need in children and young people who are at Gross Motor Function Classification System (GMFCS) level I, II or III? 30/08/2012
CG145/4 Intrathecal baclofen:- What is the clinical and cost effectiveness of continuous pump-administered intrathecal baclofen compared with usual care in children and young people who are at Gross Motor Function Classification System (GMFCS) level IV or V? 30/08/2012
CG145/5 Selective dorsal rhizotomy:- Does selective dorsal rhizotomy followed by intensive rehabilitation performed between the ages of 3 and 9 years in children who are at Gross Motor Function Classification System (GMFCS) level II or III result in good community mobility as a young adult? 30/08/2012
CG146/1 Using GP practice lists to identify people at high risk:- What is the clinical and cost effectiveness of using GP practice lists to identify people at high risk of fracture, leading to formal risk assessment and possible treatment? 04/09/2012
CG146/2 FRAX and QFracture in adults receiving bone protective therapy:- What is the utility of FRAX and QFracture in adults receiving bone protective therapy? 04/09/2012
CG146/3 FRAX and QFracture in adults with secondary causes of osteoporosis:- What is the utility of FRAX and QFracture in detecting risk of fragility fracture in adults with secondary causes of osteoporosis? 04/09/2012
CG146/4 Bone mineral density (BMD) with FRAX:- What is the added prognostic value of BMD in the assessment of fracture risk with FRAX? 04/09/2012
CG146/5 FRAX and QFracture in adults living in residential care:- What is the utility of FRAX and QFracture in detecting risk of fragility fracture in adults living in residential care? 04/09/2012
CG147/1 Angioplasty versus bypass surgery for treating people with critical limb ischaemia caused by disease of the infra-geniculate arteries:- What is the clinical and cost effectiveness of a 'bypass surgery first' strategy compared with an 'angioplasty first' strategy for treating people with critical limb ischaemia caused by disease of the infra-geniculate (below the knee) arteries? 03/09/2012
CG147/2 Supervised exercise programmes for treating people with intermittent claudication:- What is the clinical and cost effectiveness of supervised exercise programmes compared with unsupervised exercise for treating people with intermittent claudication, taking into account the effects on long-term outcomes and continuing levels of exercise? 03/09/2012
CG147/3 Patient attitudes and beliefs about peripheral arterial disease:- What is the effect of people's attitudes and beliefs about their peripheral arterial disease on the management and outcome of their condition? 03/09/2012
CG147/4 Primary versus secondary stenting for treating people with critical limb ischaemia caused by disease of the infra-geniculate arteries:- What is the clinical and cost effectiveness of selective stent placement compared with angioplasty plus primary stent placement for treating people with critical limb ischaemia caused by disease of the infra-geniculate arteries? 03/09/2012
CG147/5 Chemical sympathectomy for managing critical limb ischaemic pain:- What is the clinical and cost effectiveness of chemical sympathectomy in comparison with other methods of pain control for managing critical limb ischaemic pain? 03/09/2012
CG148/1 Safety and efficacy of antimuscarinics:- What is the safety and efficacy of more recently developed antimuscarinics compared with (a) placebo/usual care and (b) other antimuscarinics in the treatment of neurogenic lower urinary tract dysfunction? 04/09/2012
CG148/2 Safety and efficacy of botulinum toxin:- What is the safety and efficacy of botulinum toxin compared with (a) usual care, (b) antimuscarinics and (c) augmentation cystoplasty in people with neurogenic lower urinary tract dysfunction? 04/09/2012
CG148/3 Management strategies to reduce the risk of symptomatic urinary tract infections:- In people with neurogenic lower urinary tract dysfunction, which management strategies (including the use of prophylactic antibiotics and various invasive and non-invasive techniques to aid bladder drainage) reduce the risk of symptomatic urinary tract infections? 04/09/2012
CG148/4 Bladder management strategies:- What are the long-term risks and effects on quality of life of different bladder management strategies for lower urinary tract dysfunction in people with neurological disease? 04/09/2012
CG148/5 What is the safety and efficacy of botulinum toxin compared with (a) usual care, (b) antimuscarinics and (c) augmentation cystoplasty in people with primary cerebral conditions with lower urinary tract dysfunction? 04/09/2012
CG149/1 Screening and intrapartum antibiotic prophylaxis for group B streptococcal colonisation:- What is the clinical and cost effectiveness of intrapartum antibiotic prophylaxis targeting group B streptococcus and guided by routine antenatal screening? 03/09/2012
CG149/2 Risk factors for early-onset neonatal infection and symptoms and signs:- Which risk factors for early-onset neonatal infection, clinical symptoms and signs of infection, and laboratory investigations should be used to identify babies who should receive antibiotics? 03/09/2012
CG149/3 Intrapartum antibiotic prophylaxis in preterm labour:- What is the clinical and cost effectiveness of intrapartum antibiotic prophylaxis using benzylpenicillin in women with preterm labour? 03/09/2012
CG149/4 Investigations during antibiotic treatment:- What is the clinical and cost effectiveness of laboratory investigations used individually or in combination to exclude early-onset neonatal infection in babies receiving antibiotics for suspected infection? 03/09/2012
CG149/5 Duration of antibiotic treatment:- What is the optimal duration of treatment (course length) in babies who receive antibiotics for confirmed early-onset neonatal infection? 03/09/2012
CG150/1 Amitriptyline to prevent recurrent migraine:- Is amitriptyline a clinically and cost effective prophylactic treatment for recurrent migraine? 02/10/2012
CG150/2 Pizotifen to prevent recurrent migraine:- Is pizotifen a clinically and cost effective prophylactic treatment for recurrent migraine? 02/10/2012
CG150/3 Topiramate to prevent recurrent cluster headache:- Is topiramate a clinically and cost effective prophylactic treatment for recurrent cluster headache? 02/10/2012
CG150/4 Psychological interventions to manage chronic headache disorders:- Does a psychological intervention such as cognitive behavioural therapy (CBT) improve headache outcomes and quality of life for people with chronic headache disorders? 02/10/2012
CG150/5 Pharmacological treatments for headache prophylaxis to aid withdrawal treatment in medication overuse
headache:- Does a course of steroid treatment or pharmacological treatments used for headache prophylaxis help people with medication overuse headaches withdraw from medication?
02/10/2012
CG151/1 Service provision for neutropenic sepsis in patients with cancer:- A prospective national cohort study should be carried out to assess the incidence of suspected and proven neutropenic sepsis in patients having anticancer treatment. 02/10/2012
CG151/2 Patient support and information:- A descriptive study involving patients who have had neutropenic sepsis and their carers should be undertaken to find out what types of support and information patients and carers were given, which of these they found helpful or unhelpful, and whether they think additional or different types of support or information are needed. 02/10/2012
CG151/3 Signs and symptoms that predict neutropenic sepsis in the community:- A prospective study should be carried out to determine which signs and symptoms experienced by patients in the community predict neutropenic sepsis and the outcomes of these episodes. 02/10/2012
CG151/4 Reducing the risk of complications of anticancer treatment in children and young people, and in adults diagnosed with lymphoma:- Randomised studies should investigate primary prophylaxis of neutropenic sepsis in 2 populations: children and young people (aged under 18) having treatment for solid tumours or haematological malignancies, or stem cell transplantation; and adults (aged 18 and older) diagnosed with lymphoma. The studies should compare the effectiveness of fluoroquinolone antibiotics given alone, fluoroquinolone antibiotics given together with G-CSF preparations, and G-CSF preparations given alone. Outcome measures should include overall mortality, infectious episodes and adverse events. In addition, quality of life should be determined using quantitative and qualitative methods. The resulting data should be used to develop a cost-effectiveness analysis comparing these 3 forms of prophylaxis in children and young people having anticancer treatment, and in adults diagnosed with lymphoma. 02/10/2012
CG151/5 Switching from inpatient intravenous to outpatient oral antibiotic therapy in patients with neutropenic sepsis:- A randomised controlled trial should be undertaken to evaluate the clinical and cost effectiveness of stopping intravenous antibiotic therapy and switching to oral therapy within the first 24 hours of treatment in patients with neutropenic sepsis who are having treatment with intravenous antibiotics. The outcomes to be measured are overtreatment, death, need for critical care, length of hospital stay, duration of fever and quality of life. 02/10/2012
CG152/1 Azathioprine:- For patients with intestinal Crohn's disease, does the addition of azathioprine to glucocorticosteroid treatment at diagnosis improve the long-term outcome compared with glucocorticosteroid treatment alone? 25/10/2012
CG152/2 Enteral nutrition:- What are the benefits, risks and cost effectiveness of enteral nutrition compared with glucocorticosteroid treatment in adults and children? 25/10/2012
CG152/3 5-aminosalicylate (5-ASA) treatment:- Following successful medical induction of remission of Crohn's disease of the colon, is mesalazine more clinically and cost effective than no treatment? 25/10/2012
CG152/4 Surgery versus medical treatment for the distal ileum:- What is the effect on quality of life of medical treatment (immunosuppressive or biological therapy) compared with early surgery for Crohn's disease limited to the distal ileum? 25/10/2012
CG152/5 Patient information and support:- What are the information needs of people with Crohn's disease, as defined by people with the condition, and can education and support based on these needs lead to better clinical and quality of life outcomes? 25/10/2012
CG153/1 Assessment of disease severity and impact:- In children, young people and adults with psoriasis, can tools be developed and/or existing ones further refined and validated to:
- assess disease severity and impact in both non-specialist and specialist healthcare settings, to facilitate assessment, appropriate referral, treatment planning and measurement of outcomes
- measure burden and cumulative effect of disease activity, severity and impact for people with both psoriasis and psoriatic arthritis?
25/10/2012
CG153/2 Methotrexate and risk of hepatotoxicity:- What is the impact of methotrexate compared with other approaches to care (for example other systemic non-biological or biological treatments) on risk of significant liver disease in people with psoriasis and do risk factors such as obesity, alcohol use or diabetes alter this risk? 25/10/2012
CG153/3 Rapid escalation to systemic treatments:- In people with psoriasis, does early intervention with systemic treatments improve the long-term prognosis of psoriasis severity, comorbidities (including psoriatic arthritis), or treatment -related adverse effects, and are there any clinical (for example demographic or phenotypic) or laboratory (for example genetic or immune) biomarkers that can be used to identify those most likely to benefit from this treatment approach? 25/10/2012
CG153/4 Self-management:- Do structured psoriasis-focused self-management programmes improve patient confidence, wellbeing and disease control compared with standard care? 25/10/2012
CG153/5 Topical therapy:- In people of all ages with psoriasis: 1. How should topical therapies be used to maintain disease control i) safely; ii) effectively and iii) what are the health economic implications?
2. What are the risks of 'real life' long term corticosteroid use, are there particular people at risk
and what strategies can be used to modify or avoid risks?
25/10/2012
CG154/1 Early pregnancy assessment units:- A national evaluation of early pregnancy assessment unit service provision should be carried out to identify factors affecting outcomes. Factors should include whether care is provided in a dedicated unit, staffing configuration and opening hours of dedicated services. Outcomes should include both process (service) outcomes and pregnancy-related outcomes. Data collected should be used to analyse the cost effectiveness of early pregnancy assessment units compared with other models of care. 18/12/2012
CG154/2 Ultrasound for determining a viable intrauterine pregnancy:- How does the timing and frequency of ultrasound examination affect diagnosis and outcomes of early pregnancy complications, including women's experience and cost effectiveness? 18/12/2012
CG154/3 Progesterone/progestogen for threatened miscarriage Are progesterone or progestogens effective in treating threatened miscarriage? 18/12/2012
CG154/4 Management of miscarriage:- In women with confirmed miscarriage, does the type of management strategy (expectant, medical and surgical) impact on women's experience, including psychological and emotional outcomes? 18/12/2012
CG154/5 Surgical compared with medical management of ectopic pregnancy:- In women with ectopic pregnancy, does the type of intervention (laparoscopy or medical management) impact on women's experience, including psychological and emotional outcomes? 18/12/2012
CG155/1 What are the long-term outcomes, both psychotic and nonpsychotic, for children and young people with attenuated or transient psychotic symptoms suggestive of a developing psychosis, and can the criteria for 'at risk states' be refined to better predict those who will and those who will not go on to develop psychosis? 30/01/2013
CG155/2 What is the clinical and cost effectiveness of omega-3 fatty acids in the treatment of children and young people considered to be at high risk of developing psychosis? 30/01/2013
CG155/3 What is the clinical and cost effectiveness for family intervention combined with individual CBT in the treatment of children and young people considered to be at high risk of developing psychosis and their parents or carers? 30/01/2013
CG155/4 What is the clinical and cost effectiveness of psychological intervention alone, compared with antipsychotic medication and compared with psychological intervention and antipsychotic
medication combined, in young people with first episode psychosis?
30/01/2013
CG155/5 What is the clinical effectiveness of clozapine for children and young people with schizophrenia with symptoms unresponsive to antipsychotic medication and psychological treatment combined? 30/01/2013
CG155/6 What is the most effective management strategy for preventing the development of excessive weight gain and metabolic syndrome associated with the use of antipsychotic medication in children and
young people?
30/01/2013
CG156/1 Expectant management before IVF:- What is the optimum period of expectant management for women of different age groups before invasive treatment such as IVF is considered? 27/02/2013
CG156/2 Embryo selection for single embryo transfer:- Further research is needed to improve embryo selection to facilitate single embryo transfers. 27/02/2013
CG156/3 Adjuvant luteal phase support treatments in IVF:- Further research is needed to assess the efficacy of adjuvant luteal phase support treatments such as low-dose aspirin, heparin, prednisolone, immunoglobulins and/or fat emulsions. 27/02/2013
CG156/4 Long-term safety of ovarian stimulation and ovulation induction for women:- Is there an association between ovulation induction or ovarian stimulation and adverse long-term (over 20 years) effects in women in the UK? 27/02/2013
CG156/5 Long-term effects of IVF with or without intracytoplasmic sperm injection in children:- What are the long-term (over 20 years) effects of IVF with or without intracytoplasmic sperm injection (ICSI) in children in the UK? 27/02/2013
CG156/6 People who are concerned about their fertility should be informed that the effectiveness of complementary therapies for fertility problems has not been properly evaluated and that further research is needed before such interventions can be recommended. [2004] 27/02/2013
CG156/7 The effectiveness of pulsatile gonadotrophin-releasing hormone in women with clomifene citrate-resistant polycystic ovary syndrome is uncertain and is therefore not recommended outside a research context. [2004] 27/02/2013
CG157/1 Phosphate binders in adults with chronic kidney disease (CKD) stage 4 or 5:- Which binders are most effective in controlling serum phosphate in adults with stage 4 or 5 CKD who are not on dialysis? 27/03/2013
CG157/2 Effectiveness and safety of aluminium hydroxide in adults:- In adults with stage 4 or 5 chronic kidney disease (CKD), including those on dialysis, what is the long-term effectiveness and safety of aluminium hydroxide in controlling serum phosphate? 27/03/2013
CG157/3 Effectiveness and safety of magnesium carbonate in adults:- In adults with stage 4 or 5 chronic kidney disease (CKD), including those on dialysis, what is the long-term effectiveness and safety of magnesium carbonate in controlling serum phosphate? 27/03/2013
CG157/4 Phosphate binders in children Which binders are most effective in controlling serum phosphate in children with stage 4 or 5 chronic kidney disease (CKD), including those who are on dialysis? 27/03/2013
CG157/5 Sequencing and combining of phosphate binders in adults:- For adults with stage 4 or 5 chronic kidney disease (CKD), including those on dialysis, what is the most effective sequence or combination of phosphate binders to control serum phosphate? 27/03/2013
CG158/1 Parent training programmes for children aged 12 years and over with a conduct disorder:- What is the effectiveness of parent training programmes for conduct disorders in children and young people aged 12 years and over? 27/03/2013
CG158/2 Improving uptake of and engagement with interventions for conduct disorders:- What strategies are effective in improving uptake of and engagement with interventions for conduct disorders? 27/03/2013
CG158/3 Maintaining the benefits of treatment and preventing relapse after successful treatment for conduct disorder:- What is the effectiveness of interventions to maintain the benefits of treatment and prevent relapse after successful treatment for conduct disorder? 27/03/2013
CG158/4 Combining treatment for mental health problems in parents with treatment for conduct disorders in their
children:- What is the efficacy of combining treatment for mental health problems in parents with treatment for conduct disorders in their children?
27/03/2013
CG158/5 Classroom-based interventions for conduct disorders:- What is the efficacy of classroom-based interventions for conduct disorders? 27/03/2013
CG159/1 Adults' uptake of and engagement with interventions for social anxiety disorder:- What methods are effective in improving uptake of and engagement with interventions for adults with social anxiety disorder? 13/06/2013
CG159/2 Specific versus generic CBT for children and young people with social anxiety disorder:- What is the clinical and cost effectiveness of specific CBT for children and young people with social anxiety disorder compared with generic anxiety-focused CBT? 13/06/2013
CG159/3 The role of parents in the treatment of children and young people with social anxiety disorder:- What is the best way of involving parents in the treatment of children and young people (at different stages of development) with social anxiety disorder? 13/06/2013
CG159/4 Individual versus group CBT for children and young people with social anxiety disorder:- What is the clinical and cost effectiveness of individual and group CBT for children and young people with social anxiety disorder? 13/06/2013
CG159/5 Combined interventions for adults with social anxiety disorder:- What is the clinical and cost effectiveness of combined psychological and pharmacological interventions compared with either intervention alone in the treatment of adults with social anxiety disorder? 13/06/2013
CG160/1 Symptoms and signs of serious illness: - NICE recommends a UK-based epidemiological study on the symptoms and signs of serious illness. [new 2013] 13/06/2013
CG160/2 Management by remote assessment:- NICE recommends that a UK study is undertaken to determine the validity of symptoms reported on remote assessment for children with fever. [2007] 13/06/2013
CG160/3 Diagnosis:- NICE recommends that a UK study of the performance characteristics and cost-effectiveness
of procalcitonin versus C-reactive protein in identifying serious bacterial infection in children with fever without apparent source be carried out. [2007]
13/06/2013
CG160/4 Antipyretics:- NICE recommends that studies are conducted in primary care and secondary care to
determine whether examination or re-examination after a dose of antipyretic medication is of
benefit in differentiating children with serious illness from those with other conditions. [2007]
13/06/2013
CG160/5 Home-based antipyretic use:- NICE recommends studies on home-based antipyretic use and parental perception of distress caused by fever. [new 2013] 13/06/2013
CG161/1 Environmental adaptations aimed at reducing the risk of falling in older inpatients:- What environmental adaptations can be made in existing inpatient units, and should be considered when inpatient units are built, to reduce the risk of falls and injuries in older inpatients? 12/07/2013
CG161/2 Prevalence of risk factors for falling in older inpatients:- Which risk factors for falling that can be treated, improved or managed during the hospital stay are most prevalent in older patients who fall in inpatient settings in the UK? 12/07/2013
CG161/3 Causes of unwitnessed falls among older inpatients:- What are the causes of unwitnessed falls among older inpatients? 12/07/2013
CG161/4 Interventions for preventing falls in older inpatients:- How can falls among older inpatients be prevented? Which patients are most likely to benefit from falls prevention interventions, and does the effectiveness of interventions relate to the patient's length of stay? 12/07/2013
CG162/1 Upper limb electrical stimulation:- What is the clinical and cost effectiveness of electrical stimulation (ES) as an adjunct to rehabilitation to improve hand and arm function in people after stroke, from early rehabilitation through to use in the community? 12/07/2013
CG162/2 Intensive rehabilitation after stroke:- In people after stroke what is the clinical and cost effectiveness of intensive rehabilitation (6 hours per day) versus moderate rehabilitation (2 hours per day) on activity, participation and quality of life outcomes? 15/07/2013
CG162/3 Neuropsychological therapies:- Which cognitive and which emotional interventions provide better outcomes for identified subgroups of people with stroke and their families and carers at different stages of the stroke pathway? 15/07/2013
CG162/4 Shoulder pain:- Which people with a weak arm after stroke are at risk of developing shoulder pain? What management strategies are effective in the prevention or management of shoulder pain of different aetiologies? 15/07/2013
CG162/5 Offer electromechanical gait training to people after stroke only in the context of a research study. 15/07/2013
CG163/1 Broncholalveolar lavage in the diagnosis of idiopathic pulmonary fibrosis:- What is the value of bronchoalveolar lavage in people in whom idiopathic pulmonary fibrosis is considered the most likely diagnosis when clinical and CT findings are insufficient to support a confident diagnosis? 12/07/2013
CG163/2 Surgical lung biopsy in the diagnosis of idiopathic pulmonary fibrosis:- What is the value of surgical lung biopsy in people in whom idiopathic pulmonary fibrosis is considered the most likely diagnosis when clinical and CT findings are insufficient to support a confident diagnosis? 12/07/2013
CG163/3 Pulmonary rehabilitation to improve outcomes in people with idiopathic pulmonary fibrosis:- Does pulmonary rehabilitation improve outcomes for people with idiopathic pulmonary fibrosis? 12/07/2013
CG163/4 Ambulatory oxygen to improve outcomes in idiopathic pulmonary fibrosis:- Does ambulatory oxygen improve outcomes in idiopathic pulmonary fibrosis? 12/07/2013
CG163/5 Anti-reflux therapy as a treatment for idiopathic pulmonary fibrosis:- Is anti-reflux therapy an effective treatment for idiopathic pulmonary fibrosis? 12/07/2013
CG164/1 Carrier probability calculation models:- Further research is recommended into developing and validating models for calculating carrier probability, which incorporate additional data, such as the molecular pathology of tumours and the prevalence of mutations in different ethnic groups. [new 2013] 12/07/2013
CG164/2 Rapid genetic testing:- Research is recommended to determine the benefits and harms of creating rapid access to genetic testing for people with newly diagnosed breast cancer. This research should address the optimum model for service delivery and organisation, the clinical and cost effectiveness of such a change, uptake outcomes and patients' experience. [new 2013] 12/07/2013
CG164/3 Benefits of MRI surveillance in women over 50 years:- Research is recommended to establish the risk and benefits of MRI surveillance compared with mammography in women over 50 years with a personal history of breast cancer. Studies should include sub-analysis for breast density. [new 2013] 12/07/2013
CG164/4 Chemoprevention to reduce incidence of breast cancer:- A randomised controlled trial is recommended to compare the clinical and cost effectiveness of aromatase inhibitors and tamoxifen for reducing the incidence of breast cancer in women with a family history of breast or ovarian cancer. [new 2013] 12/07/2013
CG164/5 Impact of risk-reducing surgery:- Further research is recommended to compare psychosocial and clinical outcomes in women who choose and women who do not choose to have risk-reducing surgery. [new 2013] 12/07/2013
CG165/1 Stopping antiviral treatment in HBeAg-negative disease:- Further research should be undertaken to evaluate the clinical and cost effectiveness of hepatitis B surface antigen (HBsAg) quantitative assays in determining treatment duration in hepatitis B e antigen- (HBeAg) negative disease. 12/07/2013
CG165/2 ALT values for children and young people:- Further research should be undertaken to examine whether the upper limit of normal ALT values for adults (below 30 IU/ml for males and below 19 IU/ml for females) are appropriate for use in children and young people with chronic hepatitis B when making decisions on when to initiate treatment. 12/07/2013
CG165/3 Long-term safety of tenofovir disoproxil in chronic hepatitis B:- Further research should be undertaken to determine the long-term safety of tenofovir disoproxil, including the risk of clinically significant hypophosphataemia and related bone toxicity, in people with chronic hepatitis B. The cost effectiveness of routine monitoring for phosphate loss and bone disease in people with chronic hepatitis B who are receiving tenofovir disoproxil treatment needs further evaluation. 12/07/2013
CG165/4 Prophylactic treatment in people receiving immunosuppressive therapy:- Further research should be undertaken to determine whether long-term use of mild immunosuppressive agents for autoimmune and allergic problems presents a risk for reactivation of HBV infection in people with previous or current chronic hepatitis B, including occult HBV infection. The cost effectiveness of routine tests for HBV in this population, including HBV DNA for occult HBV infection, and the need for prophylactic treatment with nucleoside or nucleotide analogues needs further evaluation. 12/07/2013
CG166/1 Induction of remission for people with moderate ulcerative colitis: prednisolone compared with
aminosalicylates:- What is the clinical and cost effectiveness of prednisolone compared with aminosalicylates for the induction of remission for people with moderate ulcerative colitis?
15/07/2013
CG166/2 Induction of remission for people with moderate ulcerative colitis: prednisolone compared with
beclometasone:- What is the clinical and cost effectiveness of prednisolone plus an aminosalicylate compared with beclometasone plus an aminosalicylate for induction of remission for people with moderate ulcerative colitis?
15/07/2013
CG166/3 Induction of remission for people with subacute ulcerative colitis that is refractory to systemic corticosteroids:- What are the benefits, risks and cost effectiveness of methotrexate, ciclosporin, tacrolimus, adalimumab and infliximab compared with each other and with placebo for induction of remission for people with subacute ulcerative colitis that is refractory to systemic corticosteroids? 15/07/2013
CG166/4 Maintenance treatment for people with mild to moderate ulcerative colitis:- What is the clinical and cost effectiveness of regular maintenance treatment compared with no regular treatment (but rapid standard treatment if a relapse occurs) in specific populations with mild to moderate ulcerative colitis? 15/07/2013
CG166/5 Risk tool for predicting the likelihood of needing surgery for adults with acute severe ulcerative colitis:- To develop and validate a risk tool that predicts the likelihood of needing surgery for adults admitted to hospital with acute severe ulcerative colitis. 15/07/2013
CG167/1 Primary PCI and fibrinolysis in people with acute STEMI who present very early:- If a person with acute STEMI presents within 1 hour of the onset of symptoms, is it better for that person to be given fibrinolysis with a short call to needle time rather than to be transferred to a centre that carries out primary PCI for primary PCI with a delay of up to 120 minutes? 31/07/2013
CG167/2 Primary PCI and fibrinolysis in people with acute STEMI who have a long anticipated transfer time for primary PCI:- In people with acute STEMI who present more than 1 hour after the onset of symptoms, is a primary PCI-related delay of 120–180 minutes associated with outcomes similar to, better or worse than pre-hospital administered fibrinolysis? 31/07/2013
CG167/3 Radial arterial access primary PCI versus femoral arterial access primary PCI:- What is the clinical and cost effectiveness of radial arterial access compared with femoral arterial access for coronary angiography or primary PCI in people with acute STEMI managed by primary PCI? 31/07/2013
CG167/4 Culprit vessel primary PCI versus multivessel PCI:- Does multivessel PCI, at the time of presentation of people with acute STEMI, confer an advantage over a strategy of 'culprit vessel only' primary PCI, followed by further elective revascularisation driven by symptoms and evidence of ischaemia? 31/07/2013
CG167/5 Relationship between volume of procedures and clinical outcomes:- What is the relationship between hospital volume of primary PCI procedures and optimal outcomes in people with acute STEMI? 31/07/2013
CG168/1 Natural history of varicose veins:- In people with varicose veins at CEAP (Clinical, etiological, anatomical and pathophysiological) stage C2 or C3, what are the factors that influence progression of the disease to CEAP stages C5 or C6? 01/08/2013
CG168/2 Compression as a management option:- What is the clinical and cost effectiveness of compression hosiery versus no compression for the management of symptomatic varicose veins? 01/08/2013
CG168/3 Compression after interventional treatment:- What is the clinical and cost effectiveness of compression bandaging or hosiery after interventional treatment for varicose veins compared with no compression? If there is benefit, how long should compression bandaging or hosiery be worn for? 01/08/2013
CG168/4 Truncal treatment with or without concurrent tributary treatment:- What is the clinical and cost effectiveness of concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal endothermal ablation for varicose veins compared with:
- truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy?
- truncal endothermal ablation with phlebectomies or foam sclerotherapy, if needed, 6–12 weeks later?
01/08/2013
CG168/5 Optimal interventional and conservative treatments at different stages of disease:- What is the optimal treatment (compression, surgery, endothermal ablation or foam sclerotherapy) for varicose veins at each of the CEAP stages, that is CEAP stages 2–3, CEAP stage 4 and CEAP stages 5–6? 01/08/2013
CG169/1 Long-term outcomes of acute kidney injury:- What are the long-term outcomes of acute kidney injury in adults, children and young people? 04/09/2013
CG169/2 Rapid referral to nephrology services for moderate to severe acute kidney injury:- What is the clinical and cost effectiveness of rapid referral (within 12 hours) to nephrology services for adults with moderate to severe (stage 2 to 3) acute kidney injury not needing critical care? 04/09/2013
CG169/3 Definition of acute kidney injury – system for staging and detection:- Can a simplified definition and staging system, based on Système International (SI) units, be used to predict short- to medium-term outcomes in acute kidney injury? 04/09/2013
CG169/4 Introducing renal replacement therapy:- What is the clinical and cost effectiveness of early versus later introduction of renal replacement therapy in patients with acute kidney injury stages 2 and 3, when there is no urgent need for therapy? 04/09/2013
CG169/5 Preventing deterioration:- What is the clinical and cost effectiveness of continuing ACE inhibitor or ARB treatment, versus stopping treatment 24 hours before cardiac surgery and resuming 24 hours after, in people with chronic kidney disease and an eGFR of less than 30 ml/min/1.73 m2? 04/09/2013
CG170/1 A key worker approach for children and young people with autism and their families:- What is the value of a key worker approach (defined by protocol and delivered in addition to usual care) for children and young people with autism in terms of parental satisfaction, functioning and stress and child psychopathology? 04/09/2013
CG170/2 Managing behaviour that challenges in children and young people with autism:- Is a group-based parent training intervention for parents or carers of children and young people with autism clinically and cost effective in reducing early and emerging behaviour that challenges in the short- and medium-term compared with treatment as usual? 04/09/2013
CG170/3 Managing sleep problems in children with autism:- Is a sleep hygiene intervention or melatonin clinically and cost effective in the management of sleep onset, night waking and reduced total sleep in children (aged 4–10 years) with autism? 04/09/2013
CG170/4 Treating comorbid anxiety in children and young people with autism:- What is the comparative clinical and cost effectiveness of pharmacological and psychosocial interventions for anxiety disorders in children and young people with autism? 04/09/2013
CG170/5 Teacher-, parent- and peer-mediated psychosocial interventions in pre-school children with autism:-
Are comprehensive early interventions that combine multiple elements and are delivered by parents and teachers (for example, the Learning Experiences – an Alternative Program for Preschoolers and their Parents [LEAP] model) effective in managing the core symptoms of autism and coexisting difficulties (such as adaptive behaviour and developmental skills) in pre-school children?
04/09/2013
CG171/1 Pelvic floor muscle training:- How effective are different pelvic floor muscle training regimens in the management of women with overactive bladder (OAB) symptoms and to whom should it be offered? 08/10/2013
CG171/2 Neurostimulation:- What is the comparative effectiveness and cost-effectiveness of transcutaneous stimulation of the sacral nerve roots, and transcutaneous and percutaneous posterior tibial nerve stimulation for the treatment of OAB? 08/10/2013
CG171/3 Botulinum toxin A:- What is the long-term effectiveness, optimal dose and optimal frequency of repeat therapy of botulinum toxin A in women with OAB based on detrusor overactivity including risk of adverse events such as urinary infection and intermittent catheterisation? 08/10/2013
CG171/4 Sequence of invasive OAB procedures:- What is the effectiveness and optimum sequence of treatment with botulinum toxin A and percutaneous sacral nerve stimulation for the treatment of OAB after failed conservative (including drug) management? 08/10/2013
CG171/5 Predictors of tape failure:- What are the effects of the following predictors on tape failure?
- Age per decade
- Lower maximum urethral closure pressure
- Secondary surgery versus primary surgery
- Higher maximal flow rate
- Concurrent pelvic organ prolapse surgery
- Nocturia versus no nocturia
- Urgency versus no urgency
- Pad weight (per 10 g)
 Previous urinary incontinence surgery versus no surgery
 Q-tip maximum straining less than 30 degrees, yes versus no
 Urge score (per 10 points)
 Urgency symptoms versus no urgency symptoms
 More than 20 procedures for each surgeon versus first 10 procedures for each surgeon
 General anaesthesia versus local anaesthesia
 BMI over 35 versus 30 or less
 Maximum urethral closure pressure of 31 or more versus 30 or less
 Primary surgery versus secondary surgery
 Preoperative anticholinergic medication use versus no use
08/10/2013
CG172/1 In people who have not undergone revascularisation after an MI, does clopidogrel and placebo have a better outcome than clopidogrel and aspirin? 19/12/2013
CG172/2 Does continuing beta-blocker treatment beyond 1 year after an MI improve outcomes for people with normal left ventricular systolic function? 19/12/2013
CG172/3 Is treatment with an oral anticoagulant, aspirin and clopidogrel preferable to treatment with an oral
anticoagulant and clopidogrel in people who have had an MI, have an indication for oral anticoagulation and are treated either medically, by primary PCI or by coronary artery bypass grafting surgery?
19/12/2013
CG172/4 What characteristics are associated with uptake and adherence to cardiac rehabilitation after an acute MI when rehabilitation is started early? 19/12/2013
CG172/5 In people who have had a STEMI who undergo primary PCI with a bare-metal stent, and 4 weeks of aspirin and clopidogrel, is there an additional benefit to continuing clopidogrel for a further 11 months? 19/12/2013
CG173/1 Monotherapy versus combination therapy for treating neuropathic pain:- What is the clinical effectiveness, cost effectiveness and tolerability of pharmacological monotherapy compared with combination therapy for treating neuropathic pain? 19/12/2013
CG173/2 Relationship between symptoms, cause of neuropathic pain and its treatment:- Is response to pharmacological treatment predicted more reliably by underlying aetiology or by symptom characteristics? 19/12/2013
CG173/3 Carbamazepine for treating trigeminal neuralgia:- What is the clinical and cost effectiveness of carbamazepine as initial treatment for trigeminal neuralgia compared with other pharmacological treatments? 19/12/2013
CG173/4 Factors affecting participation and quality of life:- What are the key factors, including additional care and support, that influence participation and quality of life in people with neuropathic pain? 19/12/2013
CG173/5 Impact of drug-related adverse effects on cost effectiveness and quality of life:- What is the impact of drug-related adverse effects on health economics and quality of life in neuropathic pain? 19/12/2013
CG173/6 Potential for dependence associated with pharmacological drugs for neuropathic pain:- Is there a potential for dependence associated with pharmacological agents for neuropathic pain? 19/12/2013
CG174/1 Assessment and monitoring:- What is the incidence of complications during, and as a consequence of, IV fluid therapy? 19/12/2013
CG174/2 IV fluid therapy for fluid resuscitation:- Are balanced solutions superior to sodium chloride 0.9% for the fluid resuscitation of patients with acute hypovolaemic shock? 19/12/2013
CG174/3 IV fluid therapy for fluid resuscitation:- Are balanced crystalloids superior to a combination of a balanced crystalloid and a gelatin suspended in a balanced solution for the fluid resuscitation of patients with acute hypovolaemic shock? 19/12/2013
CG174/4 IV fluid therapy for routine maintenance:- Does a higher sodium content IV fluid regimen for maintenance reduce the risk of developing hyponatraemia and volume depletion without increasing the risk of volume overload in hospitalised adults? 19/12/2013
CG174/5 Training and education:- Does the introduction of hospital systems that ensure:
- all hospital healthcare professionals involved in prescribing and delivering IV fluid therapy are appropriately trained in the principles of fluid prescribing and
- all IV fluid therapy-related complications are reported lead to a reduction in IV fluid-related complications and associated healthcare costs?
19/12/2013
CG175/1 Prognostic indicators:- Further research is required into the identification of prognostic indicators in order to differentiate effectively between men who may die with prostate cancer and those who might die from prostate cancer. [2008] 07/03/2014
CG175/2 Androgen deprivation therapy and/or brachytherapy added to radiotherapy for men with intermediate- and high-risk localised non-metastatic prostate cancer:- Does the addition of androgen deprivation therapy and/or brachytherapy to high-dose external beam radiotherapy improve outcomes for men with intermediate- and high-risk localised non-metastatic prostate cancer? Outcomes of interest are biochemical disease-free survival, metastasis-free survival, overall survival, side effects and quality of life. [new 2014] 07/03/2014
CG175/3 Using biomarkers to diagnose brain injury:- In adults with medium risk indications for brain injury under the 2014 NICE CT head injury guidance, what is the clinical and cost effectiveness of using the diagnostic circulating biomarker S100B to rule out significant intracranial injury? 28/02/2014
CG175/4 Bisphosphonates and denosumab to treat osteoporosis:- What is the clinical and cost effectiveness of standard care with bisphosphonates compared with denosumab to treat osteoporosis caused by long-term androgen deprivation therapy? Outcomes of interest are bone mineral density, fracture risk, tolerability and skeletal-related events. [new 2014] 07/03/2014
CG175/5 Duration of exercise to combat fatigue in men having androgen deprivation therapy:- Does a longer (more than 12 weeks) programme of supervised aerobic resistance exercise reduce fatigue more effectively than a 12-week programme in men having androgen deprivation therapy? Outcomes of interest are measures of fatigue, aerobic capacity, cardiovascular function and quality of life. [new 2014] 07/03/2014
CG176/1 Direct transport to a tertiary centre with neuroscience facilities versus transport to the nearest hospital:- Is the clinical outcome of patients with head injury with a reduced level of consciousness improved by direct transport from the scene of injury to a tertiary centre with neuroscience facilities compared with the outcome of those who are transported initially to the nearest hospital without neurosurgical facilities? 28/02/2014
CG176/2 Criteria for CT head scanning:- What is the clinical and cost effectiveness of the 2014 NICE guideline recommendation on CT head scanning versus clinical decision rules (including CHALICE, CATCH and PECARN) for selecting children and infants for head CT scanning? 28/02/2014
CG176/3 Antiplatelet and anticoagulant drugs:- In patients with head injury does the use of antiplatelet and anticoagulant drugs increase the risk of intracranial haemorrhage over and above factors included in the current recommendations for CT head scans? 28/02/2014
CG176/4 Using biomarkers to diagnose brain injury:- In adults with medium risk indications for brain injury under the 2014 NICE CT head injury guidance, what is the clinical and cost effectiveness of using the diagnostic circulating biomarker S100B to rule out significant intracranial injury? 07/03/2014
CG176/5 Predictors of long-term sequelae following head injury:- Research is needed to summarise and identify the optimal predictor variables for long-term sequelae following mild traumatic brain injury (TBI). A systematic review of the literature could be used to derive a clinical decision rule to identify relevant patients at the time of injury. This would in turn lay the foundation for a derivation cohort study. 28/02/2014
CG177/1 Treatments for osteoarthritis in very old people:- What are the short-term and long-term benefits of non-pharmacological and pharmacological treatments for osteoarthritis in very old people (for example, aged 80 years and older)? 13/03/2014
CG177/2 Combinations of treatments for osteoarthritis:- What are the benefits of combinations of treatments for osteoarthritis, and how can these be included in clinically useful, cost-effective algorithms for long-term care? 13/03/2014
CG177/3 Treating common presentations of osteoarthritis for which there is little evidence:- What are effective treatments for people with osteoarthritis who have common but poorly researched problems, such as pain in more than one joint or foot osteoarthritis? 13/03/2014
CG177/4 Biomechanical interventions in the management of osteoarthritis:- Which biomechanical interventions (such as footwear, insoles, braces and splints) are most beneficial in the management of osteoarthritis, and in which subgroups of people with osteoarthritis do they have the greatest benefit? 13/03/2014
CG177/5 Treatments that modify joint structure in people with osteoarthritis:- In people with osteoarthritis, are there treatments that can modify joint structure, resulting in delayed structural progression and improved outcomes? 13/03/2014
CG178/1 Peer support interventions:- What is the clinical and cost effectiveness of peer support interventions in people with psychosis and schizophrenia? 13/03/2014
CG178/2 People who choose not to take antipsychotic medication:- What is the clinical and cost effectiveness of psychological intervention alone, compared with treatment as usual, in people with psychosis or schizophrenia who choose not to take antipsychotic medication? 13/03/2014
CG178/3 The physical health benefits of discontinuing antipsychotic medication:- What are the short- and long-term benefits to physical health of guided medication discontinuation and/or reduction in first episode psychosis and can this be achieved without major risks? 13/03/2014
CG178/4 Maintaining the benefits of early intervention in psychosis services after discharge:- How can the benefits of early intervention in psychosis services be maintained once service users are discharged after 3 years? 13/03/2014
CG178/5 Interventions for PTSD symptoms in people with psychosis and schizophrenia:- What is the benefit of a CBT-based trauma reprocessing intervention on PTSD symptoms in people with psychosis and schizophrenia? 13/03/2014
CG179/1 Debridement:- What is the effect of enzymatic debridement of non-viable tissue compared with sharp
debridement on the rate of healing of pressure ulcers in adults?
23/05/2014
CG179/2 Negative pressure wound therapy:- Does negative pressure wound therapy (with appropriate dressing) improve the healing of pressure ulcers, compared with the use of dressing alone in adults with pressure ulcers? 23/05/2014
CG179/3 Risk assessment in neonates, infants, children and young people:- Which pressure ulcer tools are most effective for predicting pressure ulcer risk in children? 23/05/2014
CG179/4 Pressure redistributing devices: Dopressure redistributing devices reduce the development of pressure ulcers for those who are at risk of developing a pressure ulcer? 23/05/2014
CG179/5 Repositioning:- When repositioning a person who is at risk of developing a pressure ulcer, what is the most effective position – and optimum frequency of repositioning – to prevent a pressure ulcer
developing?
23/05/2014
CG180/1 Cognitive behavioural therapy for people with atrial fibrillation:- What is the clinical and cost effectiveness of cognitive behavioural therapy (CBT) compared with usual care for people with newly diagnosed atrial fibrillation? 30/09/2014
CG180/2 Rate control drug treatment for people aged 75 and over with atrial fibrillation:- What is the comparative effectiveness of the 3 main drug classes used for rate control (beta-blockers, calcium-channel blockers and digoxin) in people aged 75 and over with atrial fibrillation in controlling symptoms, improving quality of life and reducing morbidity and mortality? 13/10/2014
CG180/3 Case volume as an indicator of quality for people offered left atrial catheter ablation:- What is the effect of case volume on complications and outcomes after left atrial catheter ablation? 13/10/2014
CG180/4 Non-vitamin K antagonist oral anticoagulants:- Do people with atrial fibrillation whose anticoagulant control is poor, or is predicted to be poor, with warfarin benefit from changing to one of the non-vitamin K antagonist (non-VKA) oral anticoagulants? 13/10/2014
CG180/5 Stroke risk assessment:- Can routine data from UK primary care databases clarify stroke risk in people with atrial fibrillation according to baseline risk factors and treatment? 13/10/2014
CG181/1 What is the effectiveness of age alone and other routinely available risk factors compared with the formal structured multifactorial risk assessment to identify people at high risk of developing CVD? 07/10/2014
CG181/2 What is the improvement in the cost-effectiveness metrics for statin therapy in reducing CVD that can be obtained when using a complete individual patient-based outcomes meta-analysis data set compared with using published outcomes data? 07/10/2014
CG181/3 What is the effectiveness of statin therapy in older people? 07/10/2014
CG181/4 What is the effectiveness of statins and/or other LDL-cholesterol-lowering treatment in people with type 1 diabetes? 07/10/2014
CG181/5 What is the clinical effectiveness and rate of adverse events of statin therapy using atorvastatin 20 mg per day compared with atorvastatin 40 mg per day and atorvastatin 80 mg per day in people without established CVD? 07/10/2014
CG182/1 Does the provision of educational and supportive interventions to people with chronic kidney disease (CKD) by healthcare professionals increase patients' skills and confidence in managing their conditions and improve clinical outcomes? 07/10/2014
CG182/2 For people with CKD at the highest risk of cardiovascular disease, what is the clinical effectiveness of low-dose aspirin compared with placebo for primary prevention of cardiovascular disease? 07/10/2014
CG182/3 For people aged over 75 years with CKD, what is the clinical effectiveness of renin–angiotensin–aldosterone system (RAAS) antagonists? 07/10/2014
CG182/4 In people with CKD who are at high risk of progression, what is the clinical and cost effectiveness
of uric acid-lowering agents on the progression of CKD and on mortality?
07/10/2014
CG182/5 In people with hyperparathyroidism secondary to CKD, does treatment with vitamin D or vitamin D analogues improve patient-related outcomes? 07/10/2014
CG183/1 Designing systems for documenting drug allergy:- Which documentation strategies would be most clinically and cost effective to minimise the number of people who are re-exposed to drugs to which they have a suspected or confirmed allergy, looking in particular at:
- electronic health records that include features specifically designed to record and alert
clinicians to drug allergy information, compared with systems without such features and
- different formats for patient-held, structured drug allergy documentation?
15/10/2014
CG183/2 Communicating information about drug allergy:- In people with suspected or confirmed drug allergies, are patient-focused information strategies more effective than standard NHS practice in increasing people's likelihood of disclosing their drug allergy (or their suspected drug allergy) and therefore reducing the risk of being re-exposed to the affected drug? 15/10/2014
CG183/3 Using selective cyclooxygenase 2 inhibitors in people with previous severe allergic reactions to non-selective non-steroidal anti-inflammatory drugs:- Should all patients who have experienced a severe allergic reaction to a non-selective non-steroidal anti-inflammatory drug (NSAID) be assessed by specialist drug allergy services or should they be advised to take a selective cyclooxygenase 2 (COX 2) inhibitor without further investigations if clinically appropriate? 15/10/2014
CG183/4 Oral antibiotic challenge for diagnosing antibiotic allergy in children:- In children who have a suspected allergy to an antibiotic, is it clinically and cost effective to proceed directly (without prior skin or intradermal tests) to a diagnostic oral antibiotic challenge rather than referring them to specialist drug allergy services? 15/10/2014
CG184/1 Patient characteristics, risk factors and predictors that indicate endoscopy for excluding Barrett's oesophagus:- In people who experience symptoms of gastro-oesophageal reflux disease (GORD) or symptoms suggestive of GORD, what patient characteristics, risk factors and predictors indicate when endoscopy is needed to exclude Barrett's oesophagus? 15/10/2014
CG184/2 Laparoscopic fundoplication compared with medical management:- What is the effectiveness of laparoscopic fundoplication compared with medical management in people with GORD that does not respond to optimal proton pump inhibitor (PPI) treatment? 15/10/2014
CG184/3 Effective proton pump inhibitor dosage for severe erosive reflux disease:- What is the clinical effectiveness of double-dose PPIs in people with severe erosive reflux disease (Los Angeles classification grade C/D or Savary–Miller grade 3/4):
- to reduce severe oesophagitis
- to control symptoms
- as maintenance therapy?
15/10/2014
CG184/4 Other specialist management:- What specialist management is effective for people whose symptoms do not respond to PPIs despite optimum primary care, or for people whose symptoms return after surgery? 15/10/2014
CG184/5 Specialist investigation:- What specialist investigations should be conducted to exclude a diagnosis of functional dyspepsia in people with uninvestigated dyspepsia that does not respond to PPIs or H2 receptor antagonists (H2RAs) despite optimum primary care? 15/10/2014
CG185/1 Psychological interventions for young people with bipolar depression:- What is the clinical and cost effectiveness of structured psychological interventions for young people with bipolar depression? 15/10/2014
CG185/2 Maintenance treatment:- In the maintenance treatment of bipolar disorder, what is the relative effect on quality of life of lithium, an antipsychotic (haloperidol, olanzapine, quetiapine or risperidone), or a combination of lithium and an antipsychotic? 15/10/2014
CG185/3 Antidepressants combined with antimanic medication in bipolar depression:- What is the clinical and cost effectiveness of fluoxetine combined with olanzapine versus an alternative selective serotonin reuptake inhibitor (SSRI) combined with olanzapine in the treatment of moderate to severe bipolar depression? 15/10/2014
CG185/4 A specialised collaborative care service for people with bipolar disorder:- What is the clinical and cost effectiveness of a specialised collaborative care service for people admitted to hospital with bipolar disorder compared with usual treatment delivered by generic care services? 15/10/2014
CG185/5 Cognitive behavioural therapy for the long-term management of bipolar disorder:- What is the clinical and cost effectiveness of face-to-face cognitive behavioural therapy (CBT) compared with internet-facilitated CBT in the long-term management of bipolar disorder? 15/10/2014
CG186/1 What is the clinical and cost effectiveness of cognitive rehabilitation for people with Multiple sclerosis (MS)? 27/11/2014
CG186/2 Is intravenous methylprednisolone more clinically and cost effective than oral methylprednisolone in people with relapsing–remitting Multiple Sclerosis (MS) and people with secondary progressive MS with continued relapses? 27/11/2014
CG186/3 What is the optimal frequency, intensity and form of rehabilitation for mobility problems in people with Multiple Sclerosis (MS)? 27/11/2014
CG186/4 What non-pharmacological interventions are effective in reducing spasticity in people with Multiple Sclerosis (MS)? 27/11/2014
CG186/5 Can vitamin D slow down the progression of disability in Multiple Sclerosis (MS)? 27/11/2014
CG187/1 In people with acute heart failure, congestion and worsening renal function, does the addition of low-dose dopamine to standard therapy lead to greater diuresis and renal protection compared with adding placebo to standard therapy? 27/11/2014
CG187/2 In people with acute heart failure and persistent congestion, does the addition of a thiazide diuretic to standard therapy lead to greater diuresis compared with adding placebo to standard therapy? 27/11/2014
CG187/3 In people with acute heart failure and hypoperfusion syndrome, is the use of intra-aortic balloon counter-pulsation pump (IABP) better than the use of intravenous inotropes? 27/11/2014
CG187/4 In people with decompensated heart failure, fluid congestion and diuretic resistance, does ultrafiltration lead to more rapid and effective decongestion compared with continuing diuretictreatment? 27/11/2014
CG188/1 What are the long-term benefits and harms, and cost effectiveness of endoscopic ultrasound (EUS) compared with magnetic resonance cholangiopancreatography (MRCP) in adults with suspected common bile duct stones? 27/11/2014
CG188/2 What are the benefits and harms, and cost effectiveness of routine intraoperative cholangiography in people with low to intermediate risk of common bile duct stones? 27/11/2014
CG188/3 What models of service delivery enable intraoperative endoscopic retrograde cholangiopancreatography (ERCP) for bile duct clearance to be delivered within the NHS? What are the costs and benefits of different models of service delivery? 27/11/2014
CG188/4 In adults with common bile duct stones, should laparoscopic cholecystectomy be performed early (within 2 weeks of bile duct clearance), or should it be delayed (until 6 weeks after bile duct clearance)? 27/11/2014
CG188/5 What is the long-term effect of laparoscopic cholecystectomy on outcomes that are important to patients? 27/11/2014
CG189/1 Do post-operative lifestyle intervention programmes (exercise, behavioural or dietary) improve weight loss and weight-loss maintenance following bariatric surgery? 22/12/2014
CG189/2 What is the long-term effect of bariatric surgery on diabetes-related complications and quality of
life in people with type 2 diabetes compared with optimal medical treatment?
22/12/2014
CG189/3 What are the long-term outcomes of bariatric surgery in children and young people with obesity? 22/12/2014
CG189/4 What is the best way to deliver obesity management interventions to people with particular conditions associated with increased risk of obesity (such as people with a physical disability that limits mobility, a learning disability or enduring mental health difficulties)? 22/12/2014
CG189/5 What are the long-term effects of using very-low-calorie diets (VLCDs) versus low-calorie diets
(LCDs) on weight and quality of life in patients with a BMI of 40 kg/m2 or more, including the
impact on weight cycling?
22/12/2014
CG190/1 How does the provision of accurate, evidence-based information affect women's decision-making
processes and choice of place of birth?
06/01/2015
CG190/2 What are the long-term consequences for women and babies of planning birth in different settings? 06/01/2015
CG190/3 Does enhanced education specifically about the latent first stage of labour increase the number of nulliparous women who wait until they are in established labour before attending the obstetric or midwifery unit (or calling the midwife to a home birth), compared with women who do not receive this education? 06/01/2015
CG190/4 What is the most effective treatment for primary postpartum haemorrhage? 06/01/2015
CG190/5 What are the natural frequencies of the avoidable harms that cardiotocography is intended to prevent for women who are assessed as being at low risk of complications at the start of labour? Does using cardiotocography in labours where complications develop confer a net benefit compared with intermittent auscultation? 06/01/2015
CG191/1 In moderate- to high-severity community-acquired pneumonia does using legionella and pneumococcal urinary antigen testing in addition to other routine tests improve outcomes? 06/01/2015
CG191/2 In patients hospitalised with moderate- to high-severity community-acquired pneumonia, does using C-reactive protein monitoring in addition to clinical observation to guide antibiotic duration safely reduce the total duration of antibiotic therapy compared with a fixed empirical antibiotic course? 06/01/2015
CG191/3 What is the clinical effectiveness of continuous positive pressure ventilation compared with usual care in patients with community-acquired pneumonia and type I respiratory failure without a history of chronic obstructive pulmonary disease? 06/01/2015
CG191/4 Can rapid microbiological diagnosis of hospital-acquired pneumonia reduce the use of xtendedspectrum antibiotic therapy, without adversely affecting outcomes? 06/01/2015
CG192/1 What methods can improve the identification of women at high risk of postpartum psychosis and reduce this risk? 06/01/2015
CG192/2 How safe are drugs used to treat bipolar disorder in pregnancy and the postnatal period? 06/01/2015
CG192/3 Are interventions designed to improve the quality of the mother–baby relationship in the first year after childbirth effective in women with a diagnosed mental health problem? 06/01/2015
CG192/4 Is structured clinical management for moderate to severe personality disorders in pregnancy and the postnatal period effective at improving outcomes for women and their babies? 06/01/2015
CG192/5 Are psychological interventions effective for treating moderate to severe anxiety disorders (including obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder and social anxiety disorder) in pregnancy? 06/01/2015
CG28/1 An appropriately blinded, randomised controlled trial should be conducted to assess the efficacy (including measures of family and social functioning as well as depression) and the cost effectiveness of another self-help intervention compared with computerised [Cognitive Behavioural Therapy (CBT)] and treatment as usual in a sample of children and young people treated in primary care who have been diagnosed with depression. The trial should be powered to examine the effect of treatment in children and young people separately and involve a follow-up of 12 to 18 months (but no less than 6 months).[2015] -
CG28/2 An appropriately blinded, randomised controlled trial should be conducted to assess the efficacy (including measures of family and social functioning as well as depression) and the cost effectiveness of individual [cognitive behavioural therapy] (CBT), systemic family therapy and child psychodynamic psychotherapy compared with each other and treatment as usual in a broadly based sample of children and young people diagnosed with moderate to severe depression (using minimal exclusion criteria). The trial should be powered to examine the effect of treatment in children and young people separately and involve a follow-up of 12 to 18 months (but no less than 6 months).[2015] -
CG28/3 An appropriately blinded, randomised controlled trial should be conducted to assess the efficacy (including measures of family and social functioning as well as depression) and the cost effectiveness of fluoxetine, the favoured psychological therapy [emerging from another suggested trial - as specified in paragraph 4.1 of the document], the combination of fluoxetine and psychological therapy compared with each other and placebo in a broadly based sample of children and young people diagnosed with moderate to severe depression (using minimal exclusion criteria). The trial should be powered to examine the effect of treatment in children and young people separately and involve a follow-up of 12 to 18 months (but no less than 6 months).[2015] -
CG61/2 Psychological interventions:- Are the psychological interventions [cognitive behavioural therapy] (CBT), hypnotherapy and psychological therapy all equally effective in the management of [Irritable bowel syndrome] (IBS) symptoms, either as first-line therapies in primary care, or in the treatment of people with IBS that is refractory to other treatments? -
CG61/3 Refractory [Irritable bowel syndrome] (IBS):- What factors contribute to refractory IBS? -
CG61/4 Relaxation and biofeedback:- What is the effect of relaxation and biofeedback therapies on [Irritable bowel syndrome] (IBS) symptoms and patient-related outcomes? -
CG61/5 Herbal medicines:- Are Chinese and non-Chinese herbal medicines safe and effective as first-line therapy in the treatment of [Irritable bowel syndrome] (IBS), and which is the most effective and safe option? -
CG81.1/1

What is the role of arm and shoulder specific exercises compared with and/or used as an adjunct to established lymphoedema treatments (such as compression garments and complex decongestive therapy)?

07/10/2014
DG1/1 Research is needed to quantify the health outcome benefits associated with imaging improvements with the EOS system. Examples of such benefits might include reduced back pain or reduced postural difficulties in people with scoliosis, or longer lasting and less painful joint replacements. Although research into the use of the EOS system is appropriate for all the indications included in the scope, the research most likely to be useful is for planning hip and knee replacement, including patient selection, device selection, and surgical approach. Joint replacement operations are more common than the other indications and the EOS system is thought to be most likely to provide benefit to these patients. -
DG1/2 Additional methodological research is needed to determine the most appropriate model structures to assess the benefit arising from radiation dose reduction. Additional work is needed to assess when the radiation-induced cancers actually occur and the impact of the timing of the emergence of cancer on health status. -
DG1/3 Research is needed to determine whether, and for which conditions, use of the EOS system for 3D reconstruction provides benefit for diagnosis or treatment planning. -
DG10/1 MammaPrint: research is recommended on the clinical validity of the test in people that are representative of the population in England. In particular, information on how the test reclassifies people when compared with current practice in England and their risk of distant recurrence would be useful. Research into the clinical utility of the test is also recommended; in particular, evidence of the impact of the test on clinical decision-making in England and robust data on its ability to predict the benefit of chemotherapy. 08/10/2013
DG10/2 Oncotype DX: research is recommended on the clinical utility of the test, including robust evidence on the impact of Oncotype DX on clinical decisionmaking in England (containing consideration of informal approaches compared with a formal algorithm for combining the Oncotype DX score with clinicopathological variables) and its ability to predict the benefit of chemotherapy. As part of the adoption of Oncotype DX by the NHS, NICE encourages the collection of clinical utility and any other useful data by the health system, potentially by a multicentre audit. 08/10/2013
DG10/3 IHC4: research into the analytical validity (reliability and reproducibility) of the complete IHC4 test is recommended (an algorithm combining 4 markers and classical clinical and pathological variables), particularly within the NHS and when performed in local laboratories. Studies to confirm the prognostic ability and to determine the impact of IHC4 on clinical decision-making in England and, ideally, to predict the benefit of chemotherapy are recommended. 08/10/2013
DG10/4 Mammostrat: research on the analytical validity (reliability and reproducibility) of the test is recommended. Research on the clinical utility of the test is also recommended. In particular, evidence of how the test reclassifies people's risk when compared with current practice in England, evidence on the impact of Mammostrat on clinical decision-making in England, and its ability to predict the benefit of chemotherapy. 08/10/2013
DG11/1 Further research is needed on the use and clinical utility of faecal calprotectin testing, and support pathways for the long-term management of these conditions in the community should be developed. 14/11/2013
DG11/2 Further research is needed on the impact of faecal calprotectin testing on clinical decision-making when added to current practice. This includes research into optimal cut-off values for tests and the investigation of repeat testing strategies in people with intermediate levels of faecal calprotectin. Development of a consistent definition for the 'intermediate range' is encouraged. 14/11/2013
DG11/3 Robust evidence is needed on the comparative performance of different faecal calprotectin tests, including the performance of POCTs compared with laboratory-based tests. 14/11/2013
DG12/1 NICE discussed the potential for future research. NICE accepted that there is a need to further establish the accuracy of current practice in diagnosing asthma and the incremental accuracy associated with
the addition of FeNO testing.
23/05/2014
DG12/2 NICE also considered the role of FeNO measurement in asthma management. It accepted that currently available evidence on the use of FeNO measurement in asthma management is unclear on whether benefits of treatment are maintained long-term. NICE concluded that long-term studies following patients for several years could address this gap. 23/05/2014
DG12/3 NICE also considered the role of FeNO in guiding inhaled corticosteroid dosing through stepping-up and stepping-down protocols. It accepted there is a need for more evidence on which protocols offer the safest and most optimal asthma management when used in UK clinical practice. Therefore, further studies are recommended, with consideration for the different protocols and cut-off points that may be necessary in different populations. 23/05/2014
DG13/1 NICE recommends further research to demonstrate the utility of the Sonoclot system in detecting, managing and monitoring haemostasis in cardiac surgery. 15/10/2014
DG13/2 NICE recommends further research in using viscoelastometric testing in the emergency control of bleeding after trauma and during postpartum haemorrhage to assess its effectiveness compared with standard laboratory testing. NICE recommends that outcomes should include, but may not be limited to, bleeding outcomes, mortality, duration of hospital or intensive care unit stay, transfusion rates and volumes transfused. 15/10/2014
DG13/3 NICE recommends further research comparing the clinical effectiveness of all 3 viscoelastometric devices (ROTEM, TEG and Sonoclot systems) in cardiac surgery and in the emergency control of bleeding after trauma and during postpartum haemorrhage. In particular, NICE recommends research to determine which of the parameters included in the viscoelastometric testing systems are the most significant in changing clinical decision-making and improving clinical outcomes. The degree of change needed in these parameters to affect clinical decision-making and clinical outcomes should also be considered. 15/10/2014
DG13/4 NICE recommends that future trials should include longer-term follow-up, beyond the initial hospital episode, with a view to informing the cost-effectiveness modelling and reducing uncertainty. 15/10/2014
DG13/5 NICE recommends further research to understand the characteristics of patients at high risk of haemostatic instability in whom viscoelastometric testing may be most cost effective. 15/10/2014
DG15/1 NICE recommends that robust evidence be generated to show the clinical effectiveness of the AccuTnI+3 assay for the early rule out of non-ST-segment elevation myocardial infarction (NSTEMI) in people presenting to an emergency department with acute chest pain.Where possible the accuracy of the AccuTnI+3 assay and its resulting clinical outcomes should be compared with both high-sensitivity troponin assays recommended in section 1.1 of the guidance (DG15) and standard troponin assays. 27/11/2014
DG15/2 NICE recommends the collection of further outcome data through clinical audit in centres adopting 'early rule-out protocols' with high-sensitivity troponin testing. The data collected through audit should be sufficient to allow analysis of the optimal timing of samples taken after presentation to an emergency department and the optimal high-sensitivity troponin test cut-offs for both ruling out and ruling in NSTEMI. 27/11/2014
DG15/3 NICE recommends further research comparing the clinical effectiveness of different early rule-out test protocols using high-sensitivity assays which meet the criteria applied for this assessment. NICE recommends that future studies should include consideration of the clinical effectiveness of different test strategies including those employing low diagnostic thresholds, and the impact of different test strategies on both clinician behaviour and the health system, with a view to reducing uncertainty in the economic model. Future studies should also investigate the role of sex and age-specific 99th percentile thresholds in the assessment of suspected acute coronary syndrome. The Committee also considered that it would be appropriate to include adjudication with high-sensitivity troponin assays at time points earlier than 10–12 hours as the reference standard in future studies. 27/11/2014
DG15/4 NICE recommends further research to understand the underlying biological causes and the clinical implications of chronically elevated troponin levels in older people, and people with conditions known to cause troponin elevation in the absence of ischaemia. 27/11/2014
DG16/1 NICE recommends further research to validate the accuracy and precision of the My5-FU assay for the quantitative determination of 5-fluorouracil (5-FU) at the lower end of its measuring range with analytical reference standard methods, including high-performance liquid chromatography and liquid chromatography-mass spectrometry. 07/01/2015
DG16/2 NICE recommends that robust evidence be generated to show the clinical effectiveness of pharmacokinetic dose adjustment of continuous infusion 5-FU in people with colorectal cancer. 07/01/2015
DG16/3 NICE recommends further research to establish optimal target dose ranges for 5-FU plasma levels in people with head and neck cancer, stomach cancer and pancreatic cancer. 07/01/2015
DG16/4 NICE recommended further research to explore the impact of having experiences of patients having continuous infusion 5-FU and take into account the impact on quality of life. The potential consequences of introducing pharmacokinetic dose adjustment should also be explored. 07/01/2015
DG5/1 Research is recommended on the percentage of unenhanced ultrasound scans that are inconclusive, particularly in people with cirrhosis. Such studies should explicitly define and describe why scans are 'inconclusive'. 04/09/2012
DG5/2 Research is recommended on patient preferences, and their impact on quality of life, for contrast-enhanced ultrasound and other imaging modalities. Ideally such research should compare all appropriate imaging modalities in the same patient group. 04/09/2012
DG7/1 Research is needed to establish the validity and accuracy of the SeHCAT (tauroselcholic [75selenium] acid) test and of any potential alternative technologies for measuring bile acid malabsorption in people with chronic diarrhoea diagnosed with irritable bowel syndrome (IBS-D) or Crohn's disease without ileal resection. 17/12/2012
DG7/2 Research is needed to establish the nature of bile acid malabsorption and whether bile acid malabsorption is a primary or secondary condition in people diagnosed with irritable bowel syndrome (IBS-D) or Crohn's disease without ileal resection. 17/12/2012
DG7/3 Research is needed to establish the efficacy and tolerability of bile acid sequestrants among people with irritable bowel syndrome (IBS-D) or Crohn's disease without ileal resection. 17/12/2012
DG8/1 NICE recommends that a national registry is developed to collect data on the use of the RD-100i OSNA system in detecting sentinel lymph node metastases during breast cancer surgery. It also recommends that data on all patients having whole lymph node analysis by the RD-100i OSNA system should be submitted to this registry. These data should be integrated with data from other registries for breast cancer where appropriate. 06/09/2013
DG9/1 NICE recommends that studies directly comparing different epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation test methods are performed. These studies should include the re-testing of stored non-small-cell lung cancer (NSCLC) tumour samples using different EGFR-TK mutation test methods and should link to patient outcomes. 06/09/2013
HST1/1 NICE recommends the use of eculizumab for atypical haemolytic uraemic syndrome (aHUS) only if all the following arrangements are in place:
- coordination of eculizumab use through an expert centre
- monitoring systems to record the number of people with a diagnosis of atypical
- haemolytic uraemic syndrome and the number who have eculizumab, and the dose and duration of treatment
- a national protocol for starting and stopping eculizumab for clinical reasons
- a research programme with robust methods to evaluate when stopping treatment or dose adjustment might occur.
09/02/2015
HST1/2 There is a need for further evidence on the long-term outcomes of treatment with eculizumab, and on the effect of treatment in children, adolescents and during pregnancy. The Committee supports enrolment of patients into the aHUS registry and the collection of high-quality information from these registries periodically to inform treatment decisions. 09/02/2015
IPG375/1 Current evidence on the efficacy and safety of distal iliotibial band lengthening for refractory greater trochanteric pain syndrome is inadequate in quantity and quality. Therefore this procedure should only be used in the context of research. Research studies should clearly define patient selection, and outcomes should include measures of function and quality of life. -
IPG376/1 NICE encourages further research into extracorporeal shockwave therapy (ESWT) for refractory greater trochanteric pain syndrome. Research studies should clearly describe patient selection, imaging, and treatment protocols. Outcomes should include functional and quality-of-life scores with at least 1 year of follow-up. -
IPG380/1 Further research into percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices should take the form of well-conducted trials, which should define patient selection, treatment protocols and location and types of arterial lesions treated, and report long-term patency outcomes. NICE may review this procedure on publication of further evidence. -
IPG381/1 Further research studies into deep brain stimulation (DBS) for intractable trigeminal autonomic cephalalgias (TACs) should clearly define patient selection and report the intensity and duration of stimulation, medication use and quality of life, in addition to documenting the effects on headache symptoms as clearly as possible. -
IPG383/1 Further research into hand allotransplantation should include data on long-term functional outcomes, and any occurrence of malignancy associated with long-term immunosuppression should be published. NICE may review this procedure on publication of further evidence. -
IPG387/1 NICE encourages further research into transaxial interbody lumbosacral fusion. Research outcomes should include fusion rates, pain and functional scores, quality of life measures and the frequency of both early and late complications. NICE may review this procedure on publication of further evidence. -
IPG390/1 NICE encourages research into endovascular stentgrafting of popliteal aneurysms and may review this procedure on publication of further evidence. -
IPG391/1 NICE encourages further research into the use of innovative technologies for the management of severe acute respiratory failure, and may review this guidance on publication of further evidence. -
IPG393/1 Further research into endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence should clearly define the patient groups being treated. It should also report the clinical impact in terms of quality of life and long-term outcomes. NICE may review the procedure on publication of further evidence. -
IPG394/1 Further research on external aortic root support in Marfan syndrome should report on long-term outcomes, particularly the occurrence of dissection and aortic dilatation, and the need for further procedures. -
IPG399/1 Further research for percutaneous endoscopic catheter laser balloon pulmonary vein isolation for atrial fibrillation (AF) should define patient-selection criteria and should clearly describe adverse events and long-term control of AF. -
IPG401/1 Safety of selective internal radiation therapy (SIRT) is a potentially beneficial treatment for patients with on-resectable colorectal metastases in the liver, but that more research and data collection are required to demonstrate its efficacy. -
IPG402/1 Collection and publication of data on the outcomes of percutaneous cryotherapy for renal cancer in the long term is encouraged. Further research should compare the long-term outcomes of cryotherapy with those of other treatments for renal cancer. -
IPG404/1 Any further studies on endoluminal gastroplication for gastro-oesophageal reflux disease (GORD) should include measurements of oesophageal pH and report long-term outcomes. -
IPG405/1 Further research into the comparative efficacy and safety of different surgical and ablative treatments would be useful. -
IPG406/1 NICE encourages further research into microwave ablation for the treatment of liver metastases. Research should clearly define patient selection criteria and report tumour recurrence and patient survival. Comparison with other ablative techniques would be useful. NICE may review the procedure on publication of further evidence. -
IPG409/1 Balloon dilatation of the Eustachian tube should only be used in the context of research, which should address the efficacy of the procedure in the short and longer term, and also document safety outcomes. Research studies should clearly describe which parts of the Eustachian tube are being treated and report subjective measurements of symptom improvement and objective measurements of Eustachian tube function. -
IPG412/1 Drainage, irrigation and fibrinolytic therapy (DRIFT) for post-haemorrhagic hydrocephalus in preterm infants should only be used in the context of research. Research should aim to establish the risk of secondary haemorrhage and its consequences, and the need for shunt insertion. Outcomes should include death and disability in the long-term: these should be reported separately. -
IPG413/1 NICE encourages further research into the efficacy of MRI-guided transcutaneous focused ultrasound for uterine fibroids. Research studies should report long-term outcomes, including the need for further treatment. Data on the incidence and outcomes of subsequent pregnancy in patients who choose this procedure because they wish to maintain or improve their fertility are particularly important. -
IPG415/1 Epiretinal brachytherapy for wet age-related macular degeneration (AMD) should only be used in the context of research. Research studies should address whether epiretinal brachytherapy reduces the progression of wet AMD and whether it can reduce the number of injections of antivascular endothelial growth factor agents (anti-VEGF) required. Long-term outcomes should be reported. -
IPG416/1 Further research on the efficacy of deep brain stimulation (DBS) for refractory epilepsy should describe patient selection and define clearly the target area of the brain. Outcomes should include measures of seizure frequency, functional ability, social inclusion and quality of life. -
IPG418/1 NICE encourages further research on percutaneous transluminal radiofrequency sympathetic denervation of the renal artery for resistant hypertension. Patient selection criteria should be described clearly and reported outcome measures should include adverse events and the long-term effect of the procedure on blood pressure. -
IPG418/2 NICE also encourages data collection and publication of outcomes on all patients having percutaneous transluminal radiofrequency sympathetic denervation of the renal artery for resistant hypertension. Clinicians should submit data on all patients having this procedure to the national register when it becomes available. -
IPG419/1 NICE encourages further research into bronchial thermoplasty for severe asthma. Research outcomes should include objective measurements of lung function, symptom control, medication requirements and quality of life. Long-term safety and efficacy outcomes are particularly important. Collaboration between units to publish data on patients not involved in research studies would also be valuable. -
IPG420/1 NICE encourages further research on percutaneous venoplasty for chronic cerebrospinal venous insufficiency (CCSVI) for multiple sclerosis (MS), in the form of robust controlled clinical trials. Studies should clearly define selection criteria and patient characteristics. They should also clearly define technical success which may include measurement of pressure gradients across treated vein segments before and after venoplasty. Outcomes should include clinical and quality of life measures. -
IPG421/1 NICE encourages further research into transcatheter aortic valve implantation (TAVI) for aortic stenosis. In particular, NICE encourages clinicians to enter all suitable patients into the UK TAVI trial. Information from research trials that will be useful for future guidance includes patient selection criteria and comparisons between TAVI and surgical aortic valve replacement (SAVR) in patients who would be suitable for either procedure. Outcomes should include incidence of stroke and other adverse events, symptom relief, quality of life, occurrence of aortic regurgitation, and valve durability in the short and long term. -
IPG422/1 Further research on incisionless otoplasty should describe the precise surgical techniques used and should report both short- and long-term outcomes, including the need for further procedures. -
IPG423/1 NICE encourages further research into focal cryoablation for localised prostate cancer. This should take the form of controlled studies comparing the procedure against other forms of management. Studies should clearly define patient selection criteria and should report outcomes including local recurrence in the long term. -
IPG423/2 Clinicians should collect data on all patients undergoing focal cryoablation (including details of case selection, methods of follow-up and outcomes) for local audit. Clinicians should enter details about all patients undergoing focal therapy using cryoablation for localised prostate cancer onto the European Registry for Cryosurgical Ablation of the Prostate (EuCAP) register and review clinical outcomes locally. -
IPG424/1 NICE encourages further research into focal therapy using high-intensity focused ultrasound (HIFU) for localised prostate cancer. This should take the form of controlled studies comparing the procedure against other forms of management. Studies should clearly define patient selection criteria and should report outcomes including local recurrence in the long term. -
IPG424/2 Clinicians should collect data on all patients undergoing focal high-intensity focused ultrasound (HIFU) (including details of case selection, methods of follow-up and outcomes) for local audit and for submission to national and/or international registers when these become available. The European Registry for Cryosurgical Ablation of the Prostate (EuCAP) register is being developed to receive data on focal therapy using HIFU for localised prostate cancer. When this facility is available clinicians should submit data on all patients undergoing focal therapy using HIFU for localised prostate cancer to that register. -
IPG425/1 Further information from research and collaborative data collection would be useful. This should include clearly defined patient selection criteria and long-term outcomes. NICE may review this procedure on publication of further evidence. -
IPG426/1 NICE encourages further research into micropressure therapy for refractory Ménière's disease. Research studies should report long-term outcomes, in particular the need for subsequent surgical treatment. -
IPG427/1 NICE encourages clinicians to enter patients into research studies with the particular aims of guiding selection of patients and of defining the place of percutaneous balloon cryoablation in relation to other procedures for treating atrial fibrillation. Further research should define patient selection criteria clearly and should document adverse events and long-term control of atrial fibrillation. 24/05/2012
IPG429/1 Endovascular stent insertion for intracranial atherosclerotic disease should only be used in the context of research. Research should clearly define patient selection and be designed to provide outcome data based on follow-up of at least 2 years. 28/08/2012
IPG430/1 NICE encourages further research and data collection on partial replacement of the meniscus of the knee using a biodegradable scaffold. This should include clear descriptions of patient selection and adjunctive treatments. Outcome measures should include symptom relief and functional ability in the short term and the need for further treatment in the longer term. 28/08/2012
IPG431/1 NICE encourages further research and collaborative data collection on laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease (GORD). Clear descriptions of patient selection are particularly important. Perioperative and long-term complications should be reported, together with details of long-term efficacy, including the need for further procedures and medication to control symptoms of GORD. NICE may review the procedure on publication of further evidence. 02/10/2012
IPG432/1 NICE encourages further research on laparoscopic gastric plication for severe obesity, which should include information about long-term efficacy and safety, and specifically how the procedure influences further gastric surgery. Comparison with alternative procedures would be useful. 13/12/2012
IPG434/1 NICE encourages further research and data collection on radiofrequency cold ablation for respiratory papillomatosis. In particular, research and data collection should report treatment indication (whether for primary or secondary treatment of respiratory papillomatosis), outcomes related to timing and site of disease recurrence, the need for tracheostomy after the procedure, and longer-term survival. In addition, any effect of the procedure on voice quality should be documented. 13/12/2012
IPG437/1 NICE encourages further research comparing autologous blood injection (with or without techniques to produce platelet-rich plasma) against established treatments for managing plantar fasciitis. Trials should clearly describe patient selection, including duration of symptoms and any prior treatments. Outcomes should include specific measures of pain and function. 30/01/2013
IPG438/1 NICE encourages further research comparing autologous blood injections (with or without techniques to produce platelet-rich plasma) against established nonsurgical methods for managing tendinopathy. Trials should clearly describe patient selection (including the site of tendinopathy, duration of symptoms and any prior treatments) and document whether a 'dry needling' technique is used. Outcomes should include specific measures of pain, quality of life and function, and whether subsequent surgical intervention is needed. 30/01/2013
IPG439/1 Further research and publication of observational data would be useful. Publications should describe details of patient selection, particularly in relation to previous treatments. They should also describe clinical outcomes (including all complications) and patient experience in the longer term. NICE may review the procedure on publication of further evidence. 30/01/2013
IPG441/1 Current evidence on the safety and efficacy of irreversible electroporation for treating primary lung cancer and metastases in the lung is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research. In particular, studies should report the effect of the procedure on local tumour control and patient survival. 27/02/2013
IPG442/1 Current evidence on the safety and efficacy of irreversible electroporation for treating pancreatic cancer is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research. In particular, studies should report the effect of the procedure on local tumour control and patient survival. 27/02/2013
IPG443/1 Current evidence on the safety and efficacy of irreversible electroporation for treating renal cancer is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research. In particular, studies should report the effect of the procedure on local tumour control and patient survival. 27/02/2013
IPG444/1 Current evidence on the safety and efficacy of irreversible electroporation for treating primary liver cancer is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research. In particular, studies should report the effect of the procedure on local tumour control and patient survival. 27/02/2013
IPG445/1 Current evidence on the safety and efficacy of irreversible electroporation for treating liver metastases is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research. In particular, studies should report the effect of the procedure on local tumour control and patient survival. 27/02/2013
IPG450/1 NICE encourages further research into percutaneous electrical nerve stimulation (PENS) for refractory neuropathic pain, particularly to provide more information about selection criteria and long-term
outcomes, with clear documentation of the indications for treatment.
27/03/2013
IPG453/1 Further research on prostate artery embolisation for benign prostatic hyperplasiain the form of randomised trials or cohort studies (for example, using an appropriate register) should clearly document patient selection criteria and all complications, specifically including disturbance of sexual function. Efficacy outcomes should include measures of urinary function, symptoms and quality of life. Information about longer-term outcomes, including the need for further treatment, would be valuable. 25/04/2013
IPG456/1 NICE encourages further research into sutureless aortic valve replacement for aortic stenosis. Studies should document patient selection, aortic cross-clamp times, cardiopulmonary bypass times, perioperative morbidity and specifically the incidence of paravalvular (and central) leaks in the short and long term. Research comparing outcomes of the procedure against those of standard surgical aortic valve replacement would be useful. 31/07/2013
IPG458/1 Patients with acute ischaemic stroke for whom thrombolysis is unsuitable or has failed: Submit details of all patients to the Safe Implementation of Treatments in Stroke Thrombectomy (SITS-TBY) register. NICE encourages prospective studies of mechanical clot retrieval in these patients, including comparison of outcomes against those of patients who do not have the procedure. These studies should report details of patient selection, timing of the intervention after onset of symptoms, the devices and techniques used, and functional outcomes. 31/07/2013
IPG458/2 Patients with acute ischaemic stroke for whom thrombolysis is suitable: The procedure should only be used in the context of research:
- Research should include randomised studies comparing mechanical clot retrieval against thrombolysis or other current methods of management and should report details of patient selection, timing of the intervention after onset of symptoms, the devices and techniques used, complications and functional outcomes.
- NICE encourages clinicians to enter patients into randomised trials such as the PISTE trial. In addition, details of all patients should be entered into the SITS-TBY register.
31/07/2013
IPG459/1 NICE encourages research to guide future use of selective internal radiation therapy (SIRT) for primary intrahepatic cholangiocarcinoma. This should document patient characteristics, tumour response, survival and quality of life measures, and details of other treatments used adjunctively or sequentially. NICE may review the procedure on publication of further evidence. 31/07/2013
IPG463/1 NICE encourages further research into the insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure, particularly studies that look at their long-term effects on hospital admissions and quality of life and that record adverse events. 06/09/2013
IPG464/1 Further research, in the form of comparative or observational studies, should document details of patient selection and should report all adverse events. Outcomes should include survival, quality of life, biliary patency and the need for further procedures. 08/10/2013
IPG465/1 NICE encourages further research into insertion of endobronchial valves for lung volume reduction in emphysema. Research should take the form of studies that allow comparison of the procedure with the natural history of the disease and other treatment options including surgery. The studies should define the criteria and techniques used for patient selection. Outcome measures should include lung function, dyspnoea score, exercise tolerance, quality of life and long-term safety. 08/10/2013
IPG466/1 NICE encourages further research into CXL using riboflavin and UVA for keratoconus and keratectasia, especially epithelium-on (transepithelial) CXL and the combination (CXL-plus) procedures. Details of the techniques used should be clearly described. Reported outcomes should include visual acuity, corneal topography and quality of life. Data on long-term outcomes for all types of CXL using riboflavin and UVA for keratoconus and keratectasia would be useful – specifically data about prevention of progression to corneal transplantation and about repeat procedures and their efficacy. 08/10/2013
IPG467/1 NICE encourages further research into the role of negative pressure wound therapy (NPWT) for the open abdomen. Patient selection should be documented and research should report on efficacy outcomes such as impact on wound care and healing rates, and duration of hospital stay. 19/12/2013
IPG469/1 NICE encourages further research into microwave ablation for treating primary lung cancer and metastases in the lung. Research studies should report details of patient selection and adverse events. Outcomes should include local tumour control, survival and quality of life. 19/12/2013
IPG470/1 NICE encourages further research on ultra-radical (extensive) surgery for advanced ovarian cancer, either in the form of research trials or in audits intended for publication (ideally by collaboration between units). Clinicians should ensure that details of patient selection and the precise extent of surgery are fully documented. Reported outcomes should include all complications, survival, and quality of life. Trials comparing complication rates, survival and quality of life against those of standard surgery and chemotherapy would be especially useful. 19/12/2013
IPG471/1 Well-controlled studies are needed to support the current limited evidence on weight loss in the short term. They should document patient selection, all complications (while the device is in place and after its removal) and technical problems associated with placing and removing the device. 08/10/2013
IPG473/1 NICE encourages further research into the effects of uterine artery embolisation compared with other procedures to treat adenomyosis, particularly for patients wishing to maintain or improve their fertility. 19/12/2013
IPG474/1 NICE encourages further research into arthroscopic trochleoplasty for patellar instability, including publication of consecutive patient series. Patient selection should be described in detail. Reported outcomes should include functional and quality‑of‑life measures, as well as reoperation rates. 27/02/2014
IPG475/1 NICE encourages further research and publication of results from consecutive case series of patients having this procedure. Details of patient selection should be clearly documented. Reported outcomes should include the effects of the procedure on symptoms and quality of life, the duration of benefits, and the need for further procedures. All complications should be reported. NICE may review this procedure in the light of longer-term outcomes. 07/03/2014
IPG476/1 NICE encourages further research into radiofrequency ablation of the soft palate for snoring. This could take the form of data collection, with the specific aim of documenting long-term outcomes and the need for further treatment. 07/03/2014
IPG477/1 NICE encourages further research on transcranial magnetic stimulation (TMS) for treating and preventing migraine. Data should be collected for all patients not entered into controlled trials. Studies should describe clearly whether its use is for treatment or prevention. They should report details of patient selection and the dose and frequency of use. Outcome measures should include the number and severity of migraine episodes, and quality of life in both the short and long term. The development of any neurological disorders (such as epilepsy) in the short or longer term after starting treatment should be documented. 07/03/2014
IPG479/1 Research (which may include observational studies) should clearly document the indications for use of the procedure and details of patient selection. Reported outcomes should include quality of life, overall survival and paracentesis-free survival, duration of function of the drainage system, nutritional parameters and any complications associated with its implantation or use. 13/03/2014
IPG480/1 Further research into endoscopic thoracic sympathectomy (ETS) for primary facial blushing should include clear information on patient selection and should seek to identify which patient characteristics might predict severe side effects. All complications should be reported. Outcomes should include measurements of efficacy, including quality of life and social functioning both in the short and long term, and in particular the frequency and severity of compensatory hyperhidrosis. 13/03/2014
IPG481/1 NICE encourages further research into optical coherence tomography (OCT) to guide PCI compared against percutaneous coronary intervention (PCI) with no intravascular imaging or PCI with intravascular ultrasound. Research outcomes should include data on medium- and long-term clinical outcomes, including the need for revascularisation. 13/03/2014
IPG482/1 NICE encourages further research into efficacy of extracorporeal membrane oxygenation (ECMO) for acute heart failure. This should include clear documentation of patient selection and indications for the use of ECMO. Outcome measures should include survival, quality of life and neurological status. 22/05/2014
IPG485/1 NICE encourages further research into faecal microbiota transplant for C. difficile infection, specifically to investigate optimal dosage, mode of administration and choice of donor. 22/05/2014
IPG486/1 NICE encourages further research into hysteroscopic morcellation of uterine fibroids. Patient selection should be clearly described. Outcomes should include symptom relief, quality of life, recurrence rates and information about fertility and subsequent pregnancies. All complications should be documented. 23/05/2014
IPG487/1 Further research into efficacy and safety of endoscopic thoracic sympathectomy (ETS) for primary hyperhidrosis of the upper limb should include clear information on patient selection and should seek to identify which patient characteristics might predict severe side effects. All complications should be reported. Outcomes should include measurements of efficacy, including quality of life and social functioning both in the short and long term and in particular the frequency and severity of compensatory hyperhidrosis. 27/06/2014
IPG488/1 Chemosaturation via percutaneous hepatic artery perfusion and hepatic vein isolation for primary or metastatic liver cancer ('hepatic chemosaturation') should only be performed within the context of research, which may take the form of observational studies. 26/06/2014
IPG490/1 NICE encourages further research into transcutaneous neuromuscular electrical stimulation (NMES) for oropharyngeal dysphagia, which should clearly document the indications for treatment and the details of patient selection. Research should document the timing of initiation of treatment after onset of symptoms, as well as precise information about the procedure technique. Outcome measures should include freedom from tube feeding, quality of life and duration of treatment effect. NICE may review the procedure on publication of further evidence. 27/06/2014
IPG491/1 Further research into platelet-rich plasma injections for treating osteoarthritis of the knee should clearly describe patient selection and should take the form of well-designed, controlled studies that compare the procedure against other methods of management. Outcomes should include measures of knee function, patient-reported outcome measures and the timing of subsequent interventions. Studies aimed at assessing possible cartilage repair after platelet-rich plasma injections should include detailed radiographic or MRI imaging before and after the procedure. 27/06/2014
IPG492/1 NICE encourages further research into bioresorbable stent implantation for treating coronary artery disease and may review the procedure on publication of further evidence. Details of subsequent antiplatelet therapy should be reported and outcomes should include major adverse cardiac events (MACE) and target vessel revascularisation (defined as any repeat percutaneous intervention or surgical bypass of any segment of the treated vessel), particularly in the long term (at least 2–3 years). Studies on the safety and efficacy of the procedure compared with other types of coronary stent implantation would be useful. 26/06/2014
IPG493/1 Further research into arthroscopic radiofrequency chondroplasty of the knee should clearly document patient selection and the types of chondral defects being treated. More evidence on long-term outcomes would be useful. 13/10/2014
IPG496/1 NICE encourages further research into endoscopic radiofrequency ablation for Barrett's oesophagus with no dysplasia. Studies should define clearly the policies used for histological diagnosis. Outcomes should include complete resolution of Barrett's oesophagus, change and progression to low-grade dysplasia, high-grade dysplasia or cancer. All complications should be reported, particularly development of strictures. Comparative studies against surveillance would be useful. 08/10/2014
IPG497/1 NICE encourages further research into endoscopic radiofrequency ablation for squamous dysplasia of the oesophagus, including observational data collection. Studies should clearly define patient selection. Outcomes should include completeness of ablation, resolution of squamous dysplasia, progression to cancer and quality of life. All complications should be reported, particularly development of oesophageal strictures. 07/10/2014
IPG502/1 NICE encourages further research into the use of a wireless capsule to assess motility of the gastrointestinal tract. Studies should include clear details of patient selection. They should report on the diagnostic accuracy of the procedure in different parts of the gastrointestinal tract, and should provide data on the clinical benefits of the procedure for patients. 15/10/2014
IPG504/1 NICE encourages further research into valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) for aortic bioprosthetic dysfunction. Comparative studies between ViV-TAVI and surgical aortic valve replacement (SAVR) for patients who are judged to have a low risk from SAVR should describe patient selection clearly and should report fully on complications and valve durability in the short and long term. 15/10/2014
IPG505/1 Further research should focus on the extended use of telemetric adjustable pulmonary artery banding for ventricular retraining and for its use pending the resolution of ventricular septal defects. Data collection may provide useful information. NICE may review the procedure on publication of further evidence. 06/01/2015
IPG506/1 NICE encourages further research on insertion of an annular disc implant at lumbar discectomy, particularly comparative trials. All studies should report details of patient selection and recurrence rates. 06/01/2015
IPG507/1 NICE encourages further research into insertion of a collagen plug to close an abdominal wall enterocutaneous fistula. Research should ideally take the formof prospective studies that compare the course of the enterocutaneous fistula (its natural history) with and without use of the procedure. Reports should record the conditions underlying all fistulas that are treated, their location, whether they are high or low output, and details of previous treatments. NICE may update the guidance on publication of further evidence. 06/01/2015
IPG509/1 Further research should include clear documentation of patient selection and of all complications. Outcomes should include pregnancy rates, live birth rates and instances of preterm delivery. Comparative studies would be helpful. NICE may update the guidance on publication of further evidence. 09/02/2015
IPG511/1 Further research into open reduction of slipped capital femoral epiphysis should clearly describe details of clinical presentation (for example, Loder classification), the degree of slip, its stability, and the surgical technique used; including whether surgical dislocation of the hip was done. Outcomes from 2 years onwards should include degree of correction, occurrence of avascular necrosis and need for subsequent hip surgery (and its timing). 09/02/2015
IPG512/1 Further research into implantation of a shock or load absorber for mild to moderate symptomatic medial knee osteoarthritis should include comparative studies against existing forms of management. Studies should record patient selection, functional outcomes, quality of life and complications. They should also report the nature and timing of any further surgery on the knee and the effect of removing the device. A minimum follow-up period of 2–3 years is needed. NICE may update the guidance on publication of further evidence. 09/02/2015
IPG514/1 NICE encourages further research into transanal total mesorectal excision (TaTME) of the rectum. Patient selection should be explicitly documented. If the procedure is used to treat malignancy, outcomes should include completeness of excision, recurrence rates, survival, quality of life outcomes and avoidance of the need for a stoma in the long term. All complications should be reported, specifically including incontinence. 23/04/2015
IPG515/1 Further research and data collection for inserting a balloon device to disimpact an engaged fetal head before an emergency caesarean section should report the impact of performing the procedure on the time taken from the decision to perform a caesarean section to delivery of the baby. Technical failures, including the need for repositioning of the device and for subsequent manual disimpaction of the fetal head; and any complications resulting from use of the procedure should be recorded. Fetal outcomes should also be reported. NICE may update the guidance on publication of further evidence. 23/04/2015
IPG517/1 Current evidence on the safety and efficacy of the insertion of endobronchial nitinol coils to improve lung function in emphysema is limited in quantity and quality. Therefore the procedure should only be used in the context of research. 23/04/2015
IPG518/1 Current evidence on the safety and efficacy of implantation of a duodenal–jejunal bypass liner for managing type 2 diabetes is limited in quality and quantity. Therefore the procedure should only be used in the context of research. 23/04/2015
MTG19/1 NICE considered that further research on the geko device in clinical settings could focus on reducing the current uncertainties about the reduction in relative risk in the defined patient population, and allow investigation into its use in broader patient populations. 13/10/2014
MTG20/1 Research is recommended to address uncertainties about the claimed patient and system benefits of using Parafricta Bootees and Undergarments. This should take the form of comparative research against standard care, preferably carried out in a hospital. 06/01/2015
MTG21/1 Research is recommended to address uncertainties about the claimed patient and system benefits of the ReCell Spray-On Skin system. Clinical outcomes should include time to 95% healing, length of hospital stay, cosmetic appearance of the scar and function of the burned area, compared with standard care. 06/01/2015
MTG22/1 Research is recommended to address uncertainties in the potential benefits to patients and the NHS of using VibraTip. Research is needed into the diagnostic accuracy of VibraTip compared with the 10 g monofilament and calibrated tuning fork in the diagnosis of peripheral neuropathy in people with diabetes. This research should also address the assessment of vibration perception compared with touch sensation in this clinical context. 06/01/2015
MTG3/1 NICE considered that further research would be helpful to compare the CardioQ-ODM with other techniques for monitoring cardiac output, particularly in patients in the critical care environment. -
MTG4/1 Research is recommended in the UK clinical setting to compare the BRAHMS copeptin assay in combination with cardiac troponin testing against sequential cardiac troponin testing for ruling out myocardial infarction. -
MTG5/1 Comparative research is recommended in the UK to reduce uncertainty about the outcomes of patients with chronic, ‘hard-to-heal’, complex wounds treated by the MIST Therapy system compared with those treated by standard methods of wound care. This research should define the types and chronicity of wounds being treated and the details of other treatments being used. It should report healing rates, durations of treatment (including debridement) needed to achieve healing, and quality of life measures (including quality of life if wounds heal only partially). It is recommended that centres using the MIST Therapy system take part in research that delivers these outcomes. Current users of the MIST Therapy system who are unable to join research studies should use NICE’s audit criteria to collect further information on healing rates, duration of treatment and quality of life and publish their results. -
NG1/1 What are the symptoms of gastro-oesophageal reflux gastro-oesophageal reflux disease (GORD) in infants, children and young people with a neurodisability? 09/02/2015
NG1/2 What is the effectiveness and cost effectiveness of a trial of hydrolysed formula in formula-fed infants with frequent regurgitation associated with marked distress? 09/02/2015
NG1/3 In infants, children and young people with overt or occult reflux, is fundoplication effective in reducing acid reflux as determined by oesophageal pH monitoring? 09/02/2015
NG2/1 What are the causative and contributory factors underlying the persistently very low levels of reported patient satisfaction for bladder cancer? 23/04/2015
NG2/2 Is primary radical cystectomy more effective than primary intravesical BCG (Bacille Calmette-Guérin) in high risk non-muscle-invasive bladder cancer, in terms of quality of life and cancer-specific outcomes? 23/04/2015
NG2/3 In people with high-risk non-muscle-invasive bladder cancer, are these follow-up regimens equally
effective in terms of identification of progression, cost effectiveness and health-related quality of
life?
- Cystoscopic follow-up at 3, 6, 12, 18, 24, 36 and 48 months, and then annually, interspersed
with non-invasive urinary tests.
- Cystoscopic follow-up at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48 months, and then annually
thereafter.
23/04/2015
NG2/4 In patients with muscle-invasive bladder cancer suitable for radical treatment, does the use of
biomarkers enable patients to select more effective treatment, and improve their outcomes,
compared with treatment selected without biomarkers?
23/04/2015
NG2/5 Is symptom-based review as effective as scheduled follow-up for people treated with radical
cystectomy or radical radiotherapy for organ-confined, muscle-invasive bladder cancer? Outcomes
of interest are overall survival, health-related quality of life, resource use and cost.
23/04/2015
NG3/1 What are the roles of insulin pump therapy (continuous subcutaneous insulin infusion) and
continuous glucose monitoring in helping women with diabetes to achieve blood glucose targets
before pregnancy?
23/04/2015
NG3/2 When should testing for gestational diabetes take place – in the first or second trimester? 23/04/2015
NG3/3 What are the barriers that women experience to achieving blood glucose targets? 23/04/2015
NG3/4 How can fetuses at risk of intrauterine death be identified in women with diabetes? 23/04/2015
NG3/5 Are there effective long-term pharmacological interventions to prevent the onset of type 2
diabetes that can be recommended postnatally for women who have been diagnosed with
gestational diabetes?
23/04/2015
NG4/1 What is the relationship between midwifery staffing and outcomes in maternity settings in
England, and what factors act as modifiers or confounders of the relationship between midwifery
staffing and outcomes?
23/04/2015
NG4/2 What is the effectiveness of Birthrate Plus compared with other decision support methods or
professional judgement for identifying safe midwifery staffing requirements and midwifery skill
mix for maternity services in England?
23/04/2015
NG5/1 Is a medication review more clinically and cost effective at reducing the suboptimal use of medicines and medicines-related patient safety incidents, compared with usual care or other
interventions, in children?
23/04/2015
NG5/2 Is a medication review more clinically and cost effective at reducing the suboptimal use of
medicines and improving patient-reported outcomes, compared with usual care or other
intervention in the UK setting?
23/04/2015
NG5/3 What is the clinical and cost effectiveness of using clinical decision support systems to reduce the
suboptimal use of medicines and improve patient outcomes from medicines, compared with usual
care, in the UK setting?
23/04/2015
NG5/4 What models of cross-organisational working improve clinical and cost effectiveness in relation to
the suboptimal prescribing of medicines – for example, between NHS and social care, or primary
and secondary care, or between NHS and commercial organisations?
23/04/2015
NG6/1 What effect does the temperature in the home have on the rate of illness, death and quality of life of different groups of vulnerable people? 23/04/2015
NG6/2 What are the barriers to, and facilitators for, action and coping strategies among people vulnerable to cold-related illness and death with respect to cold homes (including ventilation)? (This includes self-disconnection when using pre-payment meters.) 23/04/2015
NG6/3 How effective and cost effective are different types of intervention to prevent a range of cold-related illnesses and death? How do these vary with groups in different circumstances? 23/04/2015
NG6/4 What is the relationship between improved home energy efficiency and the indoor temperature selected by people living in a representative cohort of UK housing types? What is the trade-off between reduced fuel bills and higher indoor temperatures following alterations to home energy efficiency? 23/04/2015
NG6/5 What opportunities are there to use electronic systems to reduce the health risks associated with cold homes? For example, could temperature alert systems be linked from a smart meter to a health or social care provider? 23/04/2015
NG7/1 What is the effect on weight outcomes of a collection of individually modifiable dietary habits, physical activity and other lifestyle behaviours? 23/04/2015
NG7/2 What are effective and acceptable messages, routes and sources of communicating information about individually modifiable behaviours and weight outcomes for a range of population groups? 23/04/2015
NG7/3 What are the optimal frequency and tools for self-monitoring body weight and associated behaviours in populations with a healthy weight? 23/04/2015
PH32/1 What is the incidence and prevalence of, and what are the demographic trends in, skin cancer in the UK? (Demographic variables might include whether someone is an outdoor or indoor worker, their skin type and socioeconomic status.) -
PH32/2 What types of information provision, including mass-media campaigns, are effective and cost effective in preventing skin cancer in the UK? What factors influence effectiveness and cost effectiveness?
•Does effectiveness and cost effectiveness vary for different population groups? (Groups could be defined by gender, age, race/ethnicity, socioeconomic status or other characteristics such as lifestyle and at-risk behaviours.)
• What impact do they have on knowledge, attitudes, awareness and behaviour, including any impact on physical activity levels and vitamin D-related outcomes?
• What are the key factors that aid or hinder the success of these interventions or campaigns, including for different population groups? In particular, how does changing attitudes to sunbathing and tanning – and perceptions of the risk of skin cancer –influence success? Do attitudes vary for different population groups?
-
PH32/3 Which new (previously not researched) primary prevention interventions (that do not include information provision as a component) are effective and cost effective in preventing skin cancer in the UK? What factors influence effectiveness and cost effectiveness? -
PH32/4 What proxy outcome measures are suitable for studies of the primary prevention of skin cancer? -
PH33/1 What HIV testing services (both health and non-healthcare based) are effective and cost effective in increasing the uptake of HIV testing among black African communities living in England? (Examples may include tests in the home, within genitourinary medicine [GUM] clinics or in community venues.) Does effectiveness and cost effectiveness vary for different population groups? (Groups could be defined by gender, age, race/ethnicity, sexuality, faith, socioeconomic status or other characteristics such as lifestyle, those living in high or low HIV prevalence areas, those who have previously tested or not tested or at risk behaviours). -
PH33/2 What factors aid or hinder the provision or uptake of HIV testing services in health and non-healthcare settings from the perspective of black African communities and different service providers (for example, healthcare professionals)? What ways of working or interventions can help overcome or make use of these factors? -
PH33/3 How does HIV testing affect the subsequent sexual behaviour of black Africans living in England? How does this differ by the test result and population factors such as gender, age, sexuality, faith, culture? Does normalising HIV testing help change knowledge, attitudes and behaviour among black Africans living in England? -
PH33/4 What interventions provide an effective and cost effective way of changing risky sexual behaviour after an HIV test (positive or negative) among black African communities living in England? What mechanisms lead to change and what, in particular, is effective and cost effective with higher risk sub-groups? -
PH33/5 Are antenatal settings an effective and cost- effective location for increasing the uptake of HIV testing for black African male partners of women attending antenatal appointments? What factors influence the suitability and acceptability of antenatal settings; for example does acceptability vary by clinic setting (such as community or hospital based); by population factors (such as age, faith, race/ethnicity, or socioeconomic status) or by other characteristics such as lifestyle, those living in high or low HIV prevalence areas, whether or not they have had a previous test or whether they are involved in risky behaviours)? -
PH34/1 What interventions provide an effective and cost effective way of increasing awareness and uptake of HIV testing among men who have sex with men (at population, community and individual level)? How does HIV testing affect the subsequent sexual behaviour of men who have sex with men? How does this differ by the test result and population factors such as gender, age, sexuality, faith and culture? -
PH34/2 What interventions provide an effective and cost effective way of changing risky sexual behaviour after an HIV test (positive or negative)? What mechanisms lead to change and what, in particular, is effective with higher risk sub-groups? -
PH34/3 Are home sampling and home testing kits a reliable, effective and cost effective method of increasing the uptake of HIV testing among men who have sex with men? -
PH34/4 What interventions and approaches help reduce the stigma associated with HIV testing and a positive diagnosis among professionals, men who have sex with men and the wider population? -
PH35/1 How effective and cost effective are interventions which use either a ‘total population’ or ‘high-risk population’ approach to preventing type 2 diabetes among people from black and minority ethnic or lower socioeconomic groups? -
PH35/2 What are the most effective and cost effective ways of developing, implementing and assessing tailored and culturally appropriate community-level interventions to prevent type 2 diabetes among people at high risk? This includes people from a range of black and minority ethnic groups and those from lower socioeconomic communities. -
PH35/3 Which participatory approaches are most effective and cost effective among populations at higher risk of type 2 diabetes? This should consider the awareness, knowledge, understanding and skills of the providers of interventions for people at high risk of developing type 2 diabetes? -
PH35/4 How do socioeconomic, environmental, biological and psychosocial factors determine diet and physical activity behaviours and how do they contribute to differences in the risk of developing type 2 diabetes? -
PH35/5 How do financial factors (including incentives, pricing and taxation of food and incentives, and pricing for physical activity opportunities) affect food and physical activity choices? -
PH37/1 What factors aid or hinder the provision of tuberculosis (TB) screening services for hard-to-reach groups? -
PH37/2 What factors help or prevent hard-to-reach groups from being screened for active tuberculosis (TB): when it involves different service providers (for example, healthcare professionals, community workers) when it involves different settings and/or a different approach (for example, clinics, hospitals, detention centres, outreach, drop-in centres)? -
PH37/3 How effective and cost effective is tuberculosis (TB) testing (active and latent) for hard-to-reach groups when included as part of a broader health check (for example, blood-borne virus [BBV] screening)? -
PH37/4 How effective and cost effective is routine testing for latent tuberculosis (TB) infection and subsequent, directly observed preventive therapy (DOPT) for hard-to-reach groups at risk of poor adherence? -
PH37/5 How effective and cost effective is peer support as part of an enhanced case management (ECM) approach to ensuring hard-to-reach groups with active tuberculosis (TB) complete treatment? In particular, does effectiveness and cost effectiveness vary:
- according to the target population (that is, different hard-to-reach groups)
- by setting (for example, outreach versus clinic)
- by population (for example, age, gender, ethnicity)?
-
PH37/6 What demographic and socioeconomic factors aid or hinder treatment completion rates among hard-to-reach groups? (This includes, for example, housing, immigration status and recourse to public funds.) -
PH37/7 What is the cost of treating hard-to-reach groups with active tuberculosis (TB)? (This includes enhanced case management, housing and hospital costs and the use of new technologies.) -
PH38/1 Identification and monitoring:- Which combination of risk-assessment tools and blood tests (HbA1c or fasting plasma glucose [FPG]) are most cost effective and effective at identifying and assessing the risk of type 2 diabetes among populations at high risk? In addition, how frequently should testing take place to be efficient? How does effectiveness and cost effectiveness vary for different black and minority ethnic groups, for example, African-Caribbean and black African; people aged 18–40, people aged 75 and over, and for high-risk vulnerable adults? 30/08/2012
PH38/2 Identification and monitoring:- What are the demographic characteristics and rates of progression to type 2 diabetes among people with a high risk score but normal blood glucose levels (fasting plasma glucose of less than 5.5 mmol/l or HbA1c of less than 42 mmol/mol)? How does this compare with people who have both a high risk score and blood glucose levels that indicate impaired glucose regulation (fasting plasma glucose 5.5–6.9 mmol/l or HbA1c 42–47 mmol/mol (6.0–6.4%)? 30/08/2012
PH38/3 Identification and monitoring:- What are the most effective and cost-effective methods of increasing uptake of type 2 diabetes risk assessments and monitoring among those at greatest risk? Those at greatest risk include people from lower socioeconomic and black and minority ethnic groups, and those aged 75 or over. 30/08/2012
PH38/4 Lifestyle interventions:- Which components of an intensive lifestyle-change programme contribute most to the effectiveness and cost effectiveness of interventions to prevent or delay type 2 diabetes in those at high risk? How does this vary for different black and minority ethnic groups, for people of different ages for example, aged 18–24, 25–39 and 75 and over, and for vulnerable adults? 30/08/2012
PH38/5 Lifestyle interventions:- How effective and cost effective are different types of dietary regime in reducing short- and long-term blood glucose levels and preventing or delaying type 2 diabetes? How does this vary for different subgroups, for example, African-Caribbean and black African and other minority ethnic groups and for people of different ages, for example, aged 18–24, 25–39 and 75 and over? 30/08/2012
PH38/6 Lifestyle interventions:- How effective and cost effective are different types (and levels and frequency) of physical activity in reducing short- and long-term blood glucose levels and preventing or delaying type 2 diabetes? How does this vary for different subgroups, for example, different black and minority ethnic groups and people of different ages, for example, aged 18–24, 25–39 and 75 and over? 30/08/2012
PH38/7 Vulnerable groups:- What are the most effective and cost-effective methods for identifying, assessing and managing the risk of type 2 diabetes among high-risk, vulnerable adults? This group includes: frail older adults, homeless people, those with severe mental illness, learning or physical disabilities, prisoners, refugees, recent migrants and travellers. 30/08/2012
PH39/1 What is the natural progression of disease for South Asian users of smokeless tobacco (for example, how prevalent is oropharyngeal cancer and periodontal disease among users)? 04/10/2012
PH39/2 How prevalent is smokeless tobacco use among South Asian women who are pregnant and why? Is there a particular stage during pregnancy when smokeless tobacco is used? What impact does its use during pregnancy have on maternal and child health? 04/10/2012
PH39/3 What are the similarities and differences between smokeless tobacco and smoked tobacco in terms of chemical content and the harm that it can cause? Should interventions to help people quit smokeless tobacco differ from those used for smoked tobacco? 04/10/2012
PH39/4 How effective and cost effective are the following in terms of long-term (12 month) quit rates, and also for NHS standard, short-term quit rates (at 4 weeks and 6 months) for smokeless tobacco (confirmed by saliva cotinine test)?
- Pharmacotherapy combined with behavioural support and delivered by health professionals compared to brief advice, behavioural support or pharmacotherapy alone.
- Brief interventions (including brief advice) delivered by community members compared to brief interventions delivered by health professionals.
- Tobacco cessation services (including outreach services) that specifically focus on smokeless tobacco, compared to smokeless tobacco support provided by general tobacco cessation services.
- Training for health professionals (such as midwives, dentists and dental hygienists) to identify users of smokeless tobacco and raise awareness among them of the associated health risks.
- How does the effectiveness and cost effectiveness of the above differ by: age, gender and ethnic origin of the recipient; the status of the person delivering the intervention; the way it is delivered; its frequency, length and duration; and the setting in which it is delivered?
04/10/2012
PH39/5 Are there unintended consequences from encouraging people of South Asian origin to stop using smokeless tobacco (for example, do they experience more dental pain or start smoking more tobacco)? 04/10/2012
PH39/6 How strong are the cultural motivations (stemming from religion, tradition, media, and advertising) to use smokeless tobacco among people of South Asian origin? How do they compare with the physical addiction to nicotine? How might this information help in designing smokeless tobacco cessation programmes that are culturally appropriate? 04/10/2012
PH39/7 What components of an intervention or which general approaches work best in attracting people of South Asian origin to smokeless tobacco cessation services? How does this differ by age, gender and ethnic origin? 04/10/2012
PH40/1 How effective are interventions to promote social and emotional wellbeing among, and reduce the vulnerability of, different groups of vulnerable children aged under 5 years? 25/10/2012
PH40/2 How can the factors that pose a risk to, or protect, the social and emotional wellbeing of children aged under 5 years be identified and assessed to determine how children can benefit from different interventions? 25/10/2012
PH40/3 What approaches can be used to ensure fathers and grandparents help protect or improve the social and emotional wellbeing of vulnerable children aged under 5 years? 25/10/2012
PH40/4 What types of home-based intervention are effective in promoting the social and emotional wellbeing of vulnerable children aged under 5 years without involving the parents? (This could include childcare provided by other family members or childminders.) 25/10/2012
PH40/5 How can interventions which have been proven effective in other countries be assessed for their cultural relevance to the UK? What measures should be used to assess how transferrable they are? 25/10/2012
PH40/6 What organisational mechanisms can ensure interventions to improve the social and emotional wellbeing and 'readiness for school' of vulnerable children aged under 5 years are effectively implemented? How do these differ according to the local context? 25/10/2012
PH40/7 What are the short, medium and long-term economic benefits of interventions aimed at developing the emotional and social skills of vulnerable, preschool children – for the individual, family and wider society? How should these be assessed? 25/10/2012
PH40/8 What indicators and datasets should be used to measure and predict social and emotional wellbeing over time? Which indicators and datasets can be used to assess the long-term benefits of interventions aimed at improving the social and emotional wellbeing of vulnerable children aged under 5 years? 25/10/2012
PH41/1 How could existing guidance on evaluating complex, population-wide interventions be most usefully adapted and applied to approaches that aim to increase rates of walking and cycling? 17/12/2012
PH41/2 What key factors influence the effectiveness of population-level or whole-area approaches to encouraging walking or cycling? How do these factors interact? 17/12/2012
PH41/3 How do individual and local factors influence the effectiveness of specific approaches to encouraging walking or cycling? 17/12/2012
PH41/4 What key factors ensure people continue to walk or cycle in the long term (over a year)? How do individual interventions (such as follow-up or goal-setting) interact with environmental factors (such as distance, perception of danger or provision of facilities) in encouraging people to continue to walk or cycle? 17/12/2012
PH41/5 What key factors influence differences in walking and cycling behaviour among different groups – and what are the implications for interventions aiming to achieve population-level change and reduce inequalities? 17/12/2012
PH42/1 What is the most effective way to monitor and evaluate community-wide approaches to obesity to ensure:
1) evidence of effectiveness is gathered across the breadth of the local system and 2) data are produced to help local communities adapt and improve their approach?
13/12/2012
PH42/2 What factors are necessary for an effective and cost effective community-wide approach to obesity prevention? 13/12/2012
PH43/1 How can case-finding for hepatitis B and C be improved? What modifiable factors influence whether or not specific groups at increased risk of hepatitis B and hepatitis C infection are identified and tested? 18/12/2012
PH43/10 How many people in the UK are infected with chronic hepatitis B and C and which subgroups of the population do they come from? 18/12/2012
PH43/11 How cost effective are cohort testing programmes:
- as a stand-alone programme, or
- as an extension of the NHS Health Check programme?
18/12/2012
PH43/2 How can the uptake of hepatitis C treatment be improved? What factors influence whether or not specific groups at increased risk will begin and complete hepatitis C treatment? 18/12/2012
PH43/3 What cost-effective interventions can be used to increase hepatitis B case-finding among migrant populations in primary and secondary care? 18/12/2012
PH43/4 What cost-effective interventions ensure continuity of care for prisoners who are diagnosed with chronic hepatitis B or C in prison? 18/12/2012
PH43/5 How cost effective are alternative testing sites, such as community pharmacist programmes, for increasing the number of people who are tested and treated for hepatitis B and C? 18/12/2012
PH43/6 What are the most effective ways of involving people from groups at increased risk in awareness-raising about, and promoting testing and treatment for, hepatitis B and C infection? Specifically, how cost effective are peer mentor programmes at increasing the number of people at increased risk who are tested and treated for hepatitis B and C? 18/12/2012
PH43/7 What impact does increased knowledge and awareness of hepatitis B and C among the general public have on the uptake of testing and treatment? 18/12/2012
PH43/8 Which interventions for other communicable diseases could be used to encourage people at increased risk of hepatitis B and C infection to take up the offer of testing and treatment? 18/12/2012
PH43/9 How many children in the UK are infected with chronic hepatitis B and C and which subgroups of the population do they come from? 18/12/2012
PH44/1 How does the duration and frequency of brief advice influence its effectiveness and cost effectiveness? For example, do 'micro interventions' of less than 1–2 minutes have an impact on physical activity? 13/06/2013
PH44/2 What impact does brief advice to promote physical activity have on mental wellbeing? 13/06/2013
PH44/3 What impact does the delivery of brief advice by different primary care practitioners – for example, GPs and practice nurses – have on physical activity? For example, is the perceived value of the information greater when provided by a particular primary care practitioner? 13/06/2013
PH44/4 How do different types of training help primary care professionals identify people who are inactive and deliver brief advice? What type of training is most effective? 13/06/2013
PH44/5 How can brief advice be tailored to have the greatest impact on specific groups? For example, can it be tailored to meet the needs of people of a particular gender, socioeconomic status or with a particular disability? 13/06/2013
PH44/6 Do primary care practitioners use NICE guidance when encouraging people to be physically active? 13/06/2013
PH44/7 Are the Department of Health's 'Let's get moving' physical activity care pathway and the general practice physical activity questionnaire (GPPAQ) both commonly used in primary care? How do primary care practitioners view GPPAQ and, if they do not use it, why not? 13/06/2013
PH44/8 What infrastructures and systems help increase the number of assessments of physical activity undertaken and the delivery of brief advice? (Examples studied could include integration of brief advice into long-term disease management strategies, or the use of incentive strategies.) 13/06/2013
PH45/1 How effective are licensed nicotine-containing products when used for more than one year? What is the impact of different doses and duration of use? What is the effect on health of long-term use? What are smokers' and practitioners' views on long-term use? 15/07/2013
PH45/2 What impact does stopping smoking but continued use of licensed nicotine-containing products for over a year have on the onset and progression of smoking-related health conditions? 15/07/2013
PH45/3 How effective are interventions to help people reduce the amount they smoke (without the intention of stopping)? How great are the health benefits of smoking reduction (by substituting some cigarettes with licensed nicotine-containing products) compared to stopping smoking? What proportion of people who reduce the amount they smoke go on to stop smoking? How soon after starting to reduce the amount they smoke do they stop completely? 15/07/2013
PH45/4 How effective are different behavioural strategies in helping people to cut down, either in order to stop smoking or to reduce the amount they smoke? This should include an evaluation of behavioural support used on its own and evaluations of specific components of such support (such as scheduling). It should also include evaluations of different types of behavioural support and follow-up, delivered within a clearly defined harm-reduction intervention. 15/07/2013
PH45/5 What impact do different marketing strategies, including mass-media campaigns, have on the number of people who adopt a harm-reduction approach? For example, compare the prices, placements and promotions for different types of licensed nicotine-containing product. 15/07/2013
PH45/6 Which harm-reduction approaches are smokers using and how do these correlate with smoking rates at the population level and among particular groups? For example, how do young people respond to the wider adoption of harm-reduction approaches? Do these approaches contribute to a continued reduction in smoking prevalence among young people, or does it make stopping smoking appear less important? 15/07/2013
PH45/7 What are the most effective methods of monitoring smoking status at the population level? This includes the development of biomarkers that can distinguish between nicotine use and smoking in order to validate these measures. 15/07/2013
PH46/1 What are the cut-off points for body mass index (BMI) among adults from black, Asian and other minority ethnic groups living in the UK that can be used to classify overweight and obesity or are 'risk equivalent' to the current thresholds in relation to mortality, cancer, type 2 diabetes, stroke and myocardial infarction set for white European populations? Ideally, prospective cohort studies should be used. Studies should use objectively measured height and weight and consider incidence as well as prevalence. Estimates should be adjusted for potential confounders. 29/07/2013
PH46/2 What are the cut-off points for waist circumference among adults from black, Asian and other minority ethnic groups living in the UK that are 'risk equivalent' to the current thresholds in relation to mortality, cancer, type 2 diabetes, stroke and myocardial infarction set for white European populations? Ideally, prospective cohort studies should be used. Studies should use objectively measured waist circumference and consider incidence as well as prevalence. Estimates should be adjusted for potential confounders. 29/07/2013
PH46/3 What are the corresponding cut-off points for waist circumference among adult males and females from black, Asian and other minority ethnic groups living in the UK, based on overweight and obesity BMI classifications? 29/07/2013
PH46/4 Is the risk of ill health the same for first, second and third generation immigrants from black, Asian and other minority ethnic groups at the same BMI and waist circumference thresholds? 29/07/2013
PH46/5 What are the risks and benefits of developing single-figure cut-off points on BMI and waist circumference for black, Asian and other minority ethnic groups to help prevent diabetes and other conditions? 29/07/2013
PH46/6 Are black, Asian and other minority ethnic groups aware that they are at the same risk of type 2 diabetes and mortality at a lower BMI, compared to the white population? 29/07/2013
PH46/7 Are clinicians, practitioners and weight management service providers aware that black, Asian and other minority ethnic groups are at the same risk of type 2 diabetes and mortality at a lower BMI compared to the white population. If so do they intervene at lower BMI and waist circumference thresholds? 29/07/2013
PH46/8 How effective and cost effective are lifestyle interventions for people from black, Asian and other minority ethnic groups at different BMI and waist circumference thresholds, compared to the general population? Ideally this evidence should come from randomised controlled trials. 29/07/2013
PH47/1 Recommendation 1 Research studies and trials. Who should take action? Research councils, commissioners and funders. 14/11/2013
PH47/2 Recommendation 2 Longer-term programme evaluation. Who should take action? Research councils, commissioners and funders. 14/11/2013
PH47/3 Recommendation 3 Barriers and facilitators. Who should take action? Research councils, commissioners and funders. Researchers and investigators. 14/11/2013
PH47/4 Recommendation 4 Weight management programmes. Who should take action? Research councils, commissioners and funders. Researchers and investigators. 14/11/2013
PH48/1 How can interventions to increase the uptake and effectiveness of stop smoking interventions in acute, maternity and mental health settings be improved? (Examples include the identification and referral of smokers and staff training.) What components of an intervention help ensure someone will take up the support they are offered? How many people in these settings complete stop smoking treatment? 19/12/2013
PH48/2 How can the effectiveness and cost effectiveness (in terms of 4-week, 6- and 12-month quit and relapse rates) of intensive stop smoking interventions for people using mental health services be improved and tailored for this group? Does effectiveness or cost effectiveness differ by age, diagnosis, ethnicity, gender, inpatient or outpatient, sexual orientation or socioeconomic status? What type of training do health professionals need to deliver these interventions? Examples might include training to: build up knowledge related to tobacco dependence, its treatment and links with mental illness; develop skills in delivering support; develop a positive attitude towards delivering interventions. 19/12/2013
PH48/3 What is the effect and acceptability of approaches that aim to match nicotine dose (through licensed nicotine-containing products) to level of smoking addiction among women who are using maternity services? 19/12/2013
PH48/4 Are stop smoking interventions that include incentives to quit effective and cost effective for people using secondary care services, including women who are pregnant or have recently given birth? 19/12/2013
PH48/5 How effective and cost effective are stop smoking interventions for partners of pregnant and breastfeeding women? 19/12/2013
PH48/6 How effective and cost effective are stop smoking interventions for parents and carers of children who are using secondary care services? 19/12/2013
PH48/7 How effective and cost effective are interventions that use varenicline for people who are using acute, maternity and mental health services? 19/12/2013
PH48/8 How effective and cost effective are relapse prevention interventions aimed at people who use secondary care services who have quit? 19/12/2013
PH48/9 How can people who use secondary care services (particularly mental health services), staff and visitors, best be helped to temporarily abstain from smoking while in secondary care settings? 19/12/2013
PH49/1 Which choice architecture interventions help to reduce increased-risk and higher-risk drinking of alcohol, improve sexual health behaviours, help stop or reduce smoking, or increase the physical activity levels of the general UK population? How is this related to sociodemographic variables? 27/02/2014
PH49/2 What evidence of effectiveness is there on the use of choice architecture interventions in commercial settings to influence health-related behaviours? How can findings from commercial settings support non-commercial choice architecture approaches to support behaviour change to improve health? 27/02/2014
PH49/3 Which combinations of behaviour change techniques and modes of delivery are effective and cost effective in initiating particular behaviour changes, and in maintaining those changes? How does this vary among people from different socio-demographic groups or with different levels of motivation, access to information or skills? Include research that builds the evidence base on the effectiveness of each behaviour change technique. For example, experimental and meta-analytic work could clarify which behaviour change techniques work when, and for whom. 27/02/2014
PH49/4 Which behaviour change interventions and programmes are effective and cost effective at changing multiple behaviours and maintaining behaviour change? How does this vary among people from different sociodemographic groups? 27/02/2014
PH49/5 What characteristics of behaviour change training influence the effectiveness of behaviour change practitioners? 27/02/2014
PH49/6 How effective and cost effective are behaviour change interventions delivered remotely (that is, by telephone, text message, phone and tablet apps or the internet)? How does this vary among behaviours and among people from different sociodemographic groups? 27/02/2014
PH49/7 How do behaviour change techniques lead to change? What are the best methods of testing the relationship between the theories that describe change processes and the effectiveness of interventions in practice? 27/02/2014
PH50/1 How effective are programmes that aim to prevent domestic violence and abuse from ever happening in the first place? This includes media-based public health awareness campaigns. It also includes social movements to establish people's rights, and community-building and primary prevention activities that tackle underlying assumptions in society. (Examples of the latter might include the role and status of women.) 13/03/2014
PH50/2 How effective are combinations of interventions to deal with domestic violence and abuse in the short, medium and long term? Are the outcomes sustainable and do they have a beneficial effect on quality of life and health in the longer term? 13/03/2014
PH50/3 How effective are the following interventions in the short, medium and long term, across various levels of risk and including diverse and marginalised groups:
- advocacy
- domestic abuse recovery programmes
- perpetrator programmes
- psychological or social interventions modified for domestic violence and abuse, including programmes for those who have suffered multiple forms of abuse and those who are still experiencing it
- interventions for primary carers apart from mothers (for example, fathers, grandparents)
- interventions for other family members?
13/03/2014
PH50/4 What are the most appropriate ways to collect and manage data about domestic violence and abuse across the health, social care and criminal justice sectors? Is there value in collecting anonymised aggregate data, or is there a more useful method of data capture? 13/03/2014
PH50/5 What type of interventions (including training and referral pathways), in diverse health care settings, provide the most effective support for practitioners working with people who are experiencing, or have experienced, domestic violence and abuse? 13/03/2014
PH51/1 What are the most effective and cost effective ways to provide contraceptive services for socially disadvantaged young people to prevent unwanted pregnancies? In particular, what are the most effective and cost effective ways to provide contraceptive services for looked after children, those with learning difficulties, those who are not in education, employment or training or women who have had an abortion? 22/05/2014
PH51/2 What are the most effective ways to get socially disadvantaged young women and men involved in designing contraceptive services that meet their needs and reduce the barriers to access? 22/05/2014
PH51/3 How effective and cost effective are interventions that reduce unintended conception and abortion rates among young people aged under 25 years? 22/05/2014
PH51/4 What is the differential impact of interventions that aim to reduce unintended conception and abortion rates among young people aged under 25 years on subgroups of socially disadvantaged young people? 22/05/2014
PH51/5 What interventions and service models enable young people from diverse faith and cultural communities to access contraceptive services and meet their contraceptive needs? 22/05/2014
PH52/1 How can needle and syringe programmes encourage specific groups of people who inject drugs to use the service effectively? Examples include: those who have recently started injecting; women; sex workers; ex-prisoners; people who are homeless; people who occasionally inject drugs; and people who inject novel psychoactive drugs. 23/05/2014
PH52/2 What are the most effective and cost effective ways of delivering needle and syringe programmes to: young people aged under 18; users of image- and performance- enhancing drugs? 23/05/2014
PH52/3 What type of behaviour-change interventions delivered by needle and syringe programmes are effective in promoting safer drug use practices and reducing the incidence of overdose (apart from providing needles, syringes and other injecting equipment)? 23/05/2014
PH52/4 What types of injecting equipment (including low dead-space syringes), paraphernalia and non-injecting equipment (for example, crack pipes or foil) effectively and cost effectively reduce the harm associated with injecting drug use? 23/05/2014
PH52/5 Do needle and syringe programmes have any unintended consequences: Do they increase the uptake, frequency and length of injecting drug use? Does the provision of disposal facilities (for example, drop-boxes) affect the amount of drug-related litter in an area? Do they have a negative impact on the local community, for example, in terms of crime rates or the fear of crime? 23/05/2014
PH53/1 How effective are lifestyle weight management programmes available in the UK, when directly compared using high-quality trials? In particular, what effect do specific components of a multicomponent lifestyle weight management programme have on adherence, effectiveness and cost effectiveness? This includes:
- components, or combinations of components, that support weight loss or the prevention of weight regain
- the effect of programme length, intensity, setting and means of delivery (examples of the latter include group, individual and remote support)
- specific behaviour change techniques (using a recognised taxonomy)
- the effect of new technologies
- the effect of additional support services, such as self-help groups and networks approaches to commissioning
- processes for collecting long-term follow-up data.
03/07/2014
PH53/2 How effective and cost effective are lifestyle weight management programmes available in the UK over at least at least 3 to 5 years, and ideally beyond 10 years. Specifically:
- Do short-term (12-week) interventions provide adults with the self-management skills they need to maintain weight loss in the long term?
- Are alternative approaches to weight management (such as approaches that focus on a healthy lifestyle, behaviour change and the prevention of weight gain rather than weight loss) effective and cost effective in the long term?
- How effective and cost effective are programmes for people of different ages, gender, sexuality or from different ethnic or socioeconomic groups?
- How effective and cost effective are programmes for specific population groups, such as adults with depression or with disabilities?
03/07/2014
PH53/3 What is the effect of lifestyle weight management programmes available in the UK on:
- Changes to dietary habits and choices, physical activity level and sedentary behaviour?
- Wider lifestyle factors, such as sleeping patterns or stress management?
- Psychological issues, such as body confidence or attitude, depression, anxiety or self-esteem?
- Health conditions, such as changes to blood pressure or lipids?
- Unintended outcomes such as musculoskeletal injuries, symptoms of an eating disorder; increased anxiety or depression?
- User adherence and satisfaction?
- Quality of life?
03/07/2014
PH53/4 How can referrals to other services after involvement in a lifestyle weight management service be as effective and cost effective as possible? This includes: re-referrals to a lifestyle weight management service, referrals to other tiers of weight management services or referrals to other specialist services (such as alcohol or substance misuse). In particular:-
- How long should people wait before being re-referred to a programme?
- Does re-referral to the same (or a similar programme) influence adherence, effectiveness or cost effectiveness?
- In what circumstances should participants not be re-referred to the same (or a similar programme)?
- Who is best placed to provide ongoing support after the programme, and does this differ according to whether someone completed the programme or met their weight loss goal?
- Are there any unintended or adverse effects from repeated attempts to lose weight?
03/07/2014
PH53/5 What effect does lifestyle weight management training for health professionals and lifestyle weight management staff have on:
- The referral process, including patient satisfaction?
- Programme outcomes (weight loss and prevention of weight regain), adherence to the programme and participants' satisfaction with it?
- Staff confidence in discussing weight issues and any concerns about their own weight?
- Staff ability to deliver the programme?
- General approach of staff (that is, whether they adopt a 'respectful and nonjudgemental' approach as a result)?
03/07/2014
PH54/1 How effective and cost effective are different types of exercise referral scheme? Compare the relative effects of different models in controlled studies. Include health-related quality of life as an outcome. Compare exercise referral schemes that vary by:
- setting – for example, home-based, gym-based, community-based or outdoors
- intensity and duration – for example, a 12-week scheme involving 1 session a week, or a 6-week scheme involving 4 1-hour sessions per week
- the techniques used, for example, some use additional 'supportive' techniques such as 'motivational interviewing' and education sessions
- the target group, for example, people who are overweight and obese, people with raised blood pressure or cholesterol levels or those experiencing mild depression, anxiety or stress; or by age, gender, race or socioeconomic status
- other scheme characteristics including: design, content and delivery; referral mechanisms; choice of activity; cost and qualifications of instructors; and whether it is commissioned and delivered by an NHS, non-NHS or community-based organisation.
15/10/2014
PH54/2 What factors encourage uptake of, and adherence to, an exercise referral scheme? Factors to consider include: design, content and delivery; referral mechanisms; choice of activity; qualifications and cost of instructors. Also identify any barriers preventing participation and factors that encourage it. 15/10/2014
PH54/3 What factors encourage under-represented groups to participate in and complete an exercise referral scheme? What factors prevent these groups from participating? Under-represented groups include: people from black and minority ethnic groups, people with disabilities and those from lower socioeconomic groups. 15/10/2014
PH54/4 What is the comparative effectiveness and cost effectiveness of exercise referral schemes compared with other interventions that aim to help people to become more physically active? Relative effectiveness and cost effectiveness should be compared in controlled trials. 15/10/2014
PH55/1 What community-based interventions are effective and cost effective in improving oral health and reducing oral health inequalities among groups of adults at high risk of poor oral health? 15/10/2014
PH55/2 What community-based interventions are effective and cost effective in improving oral health and reducing oral health inequalities among groups of children at high risk of poor oral health? 15/10/2014
PH55/3 What community-based interventions are effective and cost effective at improving the uptake of, and reducing inequalities in the use of, dental services by groups of adults and children at high risk of poor oral health? 15/10/2014
PH55/4 How can healthy habits that promote oral health be supported and encouraged in families with children at high risk of poor oral health? -
PH55/5 What community-based interventions are effective and cost effective in improving dietary habits affecting the oral health of children and adults, and in particular those at high risk of poor oral health? -
PH55/6 What is the relative effectiveness and cost effectiveness of the different components of multi-component, community-based oral health improvement programmes? 27/11/2014
PH55/7 How cost effective are fluoride varnish programmes and tooth-brushing schemes? 27/11/2014
PH56/1 How effective and cost effective are interventions to increase vitamin D access, uptake, adherence or status among identified at-risk groups? Does effectiveness vary by age, gender, ethnicity, socioeconomic or other specific population characteristics (such as depression or a disability)? The following could be considered:
- availability and uptake of supplements (including the impact of the cost of supplements)
- type of supplements provided and how that impacts on adherence
- knowledge and attitudes (of both the public and health and social care practitioners).
22/12/2014
PH56/2 How cost effective are preventive approaches to vitamin D deficiency among all at-risk groups, compared with the cost of testing and treatment? This should include a comparison of universal provision of free supplements with the provision of low or standard cost supplements for different at-risk groups. (If there is any new legislation allowing for the sale of Healthy Start supplements, this would provide an opportunity to test this question.) 22/12/2014
PH56/3 How can a multiagency approach to improving awareness, availability and uptake of vitamin D supplements best be established, improved and sustained? 22/12/2014
PH56/4 What type of training and awareness-raising can improve how health and social care practitioners:
- promote vitamin D supplements among at-risk groups
- improve the local population's awareness of, and attitudes towards, vitamin D supplements
- uptake of vitamin D supplements?
22/12/2014
PH56/5 What is the best way of monitoring the local system for distributing vitamin D supplements? 06/01/2015
SG1/1 What is the relationship between the following factors and outcomes related to nursing care, patient safety and patients' and nursing staff satisfaction with the quality of care in the UK?
- Number of nursing staff
- Nursing skill mix
- Shift patterns
07/10/2014
SG1/2 How do the following factors affect the nursing staff requirement at ward level in the UK?
- Patient factors
- Patients' nursing needs (sometimes referred to as acuity and dependency)
- Time of day
- Ward layout and size (including the use of single rooms)
- Ward level team leadership and management
- Organisational training approaches
- Organisational policies and procedures (for example, productive ward, Lean)
07/10/2014
SG1/3 What is the effectiveness of using defined approaches or decision support toolkits to determine nursing staff requirements and skill mix on acute adult inpatient wards in the UK? 07/10/2014
TA161/2 [NICE] recommends research into the long-term effects of bisphosphonates on bone quality, given the inhibitory effects on bone resorption of these drugs. -
TA214/1 Further research designed to investigate differences in health-related quality of life and the clinical effectiveness of bevacizumab in subgroups, such as those with prior taxane exposure, would be particularly useful. -
TA216/1 Research should be carried out to compare the clinical effectiveness of bendamustine with chlorambucil at the higher dose used in the Chronic Lymphocytic Leukaemia Trial 4 (CLL4). -
TA217/1 Research is needed to generate robust and relevant data on the effects of treating people with Alzheimer’s disease on both short-term and long-term outcomes, disease progression through relevant health states, and quality of life. -
TA217/2 Research is needed on the impact of treating Alzheimer’s disease on mortality and institutionalisation, and to assess the relationship between disease progression and carer utility (quality of life). -
TA218/1 The Committee recommends that a study estimating utility values using directly observed health-related quality of life values (such as EQ 5D scores) in patients with myelodysplastic syndromes, chronic myelomonocytic leukaemia or acute myeloid leukaemia is conducted. -
TA220/1 NICE highlighted the importance of collecting further data within registries of patients receiving biological treatments for psoriatic arthritis to obtain information on long-term outcomes, including adverse events. -
TA222/1 NICE proposes that a trial should be undertaken to compare the efficacy of trabectedin plus pegylated liposomal doxorubicin hydrochloride (PLDH) with platinum-based chemotherapy because this is the standard treatment in the platinum-sensitive population. -
TA223/1 A trial comparing the long-term effectiveness (beyond 24 weeks) of cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate and placebo would be beneficial. It should collect utility data as well as walking distance outcomes. -
TA232/1 Research investigating the health-related quality of life of people with epilepsy would be of value. -
TA235/1 Further studies on the clinical effectiveness of mifamurtide when combined with the chemotherapy typical of UK clinical practice would be useful to determine the size of the effect of mifamurtide. -
TA235/2 Further collection of quality of life data from people who are cured and who have experience of amputation and chemotherapy are also needed. Additional data on the health effects on parents, siblings and others with life-threatening illness would also be of value. -
TA236/1 Clinical trials should be conducted comparing ticagrelor with prasugrel in people with acute coronary syndromes (ACS). -
TA236/2 Further research into whether ticagrelor is particularly beneficial in any clinical or biological subgroups would be useful. -
TA244/1 NICE recommends that a study is conducted to generate robust evidence about the benefits of roflumilast as an add-on to LAMA plus LABA/ICS or LAMA plus LABA for those people who are intolerant to ICS. -
TA244/2 Ideally roflumilast should be compared with theophylline in those people for whom theophylline would be suitable. -
TA245/1 More trials of apixaban compared with other low molecular weight heparin (LMWHs) in total hip and knee replacement would decrease the uncertainty of the clinical and cost effectiveness of these treatments. Trials directly comparing apixaban with rivaroxaban, dabigatran etexilate and fondaparinux would strengthen the evidence base for these comparisons. -
TA250/1 Health-related quality of life studies comparing eribulin with vinorelbine and capecitabine should be conducted. -
TA254/1 NICE recommends the development of patient registries for multiple sclerosis to capture long-term treatment-related outcomes. -
TA254/2 NICE recommends that a new model for multiple sclerosis is developed, ideally based on UK patient cohorts, which uses the best available evidence (including experience to date from the risk-sharing scheme) and includes all currently available treatments. -
TA261/1 Further research on the clinical effectiveness of rivaroxaban compared with low molecular weight heparin (LMWH) in patients with active cancer should be conducted. 30/08/2012
TA263/1 Studies exploring the effectiveness of bevacizumab in people previously treated with a taxane and its effects on health-related quality of life. 03/09/2012
TA266/1 NICE proposes that a clinical trial is needed to establish the relative effectiveness of mannitol compared with hypertonic saline. 13/12/2012
TA271/1 Further research to resolve uncertainties about the cost effectiveness of fluocinolone acetonide intravitreal implant for the treatment of chronic diabetic macular oedema is recommended. This should focus on a group of patients whose condition is unresponsive to other available therapies, and include measures of efficacy and health-related quality of life. 30/01/2013
TA272/1 Research on second-line treatments for transitional cell carcinoma of the urothelial tract is needed. It noted that the vinflunine studies were the only studies in patients with transitional cell carcinoma of the urothelial tract whose disease had progressed after platinum-based chemotherapy. It was noted that there is a lack of evidence for the relative effectiveness of treatment options at this stage in the pathway of care. It is recommended that studies be undertaken to investigate the relative safety and efficacy of second-line treatments for transitional cell carcinoma of the urothelial tract, particularly randomised controlled trials. 30/01/2013
TA274/1 NICE recommends that further research directly comparing the clinical and cost effectiveness of ranibizumab and bevacizumab in people with diabetic macular oedema should be conducted. 27/02/2013
TA275/1 There is a need for additional research on the management of bleeds that occur while people are receiving apixaban, rivaroxaban or dabigatran etexilate, as there are no antidotes or established treatments to stop active bleeding for these agents. 27/02/2013
TA283/1 NICE concluded that further research directly comparing the clinical and cost effectiveness of ranibizumab and bevacizumab in people with macular oedema secondary to retinal vein occlusion should be conducted. 13/06/2013
TA287/1 There have been no head-to-head trials of rivaroxaban compared with a low molecular weight heparin for people who have cancer and experience an acute pulmonary embolism or deep vein thrombosis. As in NICE technology appraisal guidance 261 it is recommended that further research should be carried out. 15/07/2013
TA287/2 Research into the long-term treatment effects of rivaroxaban is needed. 15/07/2013
TA293/1 NICE recommends that research should be carried out to directly compare eltrombopag with non-thrombopoietin receptor agonist treatments routinely used in UK clinical practice. 01/08/2013
TA293/2 NICE recommends research generating and analysing observational data including, but not limited to, the existing UK ITP Registry, which collects data on the long-term outcomes of patients treated with eltrombopag and romiplostim. 01/08/2013
TA299/1 It is a condition of the marketing authorisation for bosutinib that a single open-label multicentre efficacy and safety study is conducted of bosutinib in patients with Philadelphia-chromosome-positive chronic myeloid leukaemia previously treated with 1 or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. 19/12/2013
TA301/1 Further research is recommended to resolve uncertainties about the cost effectiveness of fluocinolone acetonide intravitreal implant for the treatment of chronic diabetic macular oedema. This should focus on a group of patients whose condition is unresponsive to other available therapies, and include measures of efficacy and health-related quality of life. Research should focus on identifying appropriate utility values, taking into account the utility values for different levels of visual acuity and the relative relationship in utility values from treating the best-seeing and the worse-seeing eye. The appropriateness of generalising utility values from one group of eye conditions to another group would also be of value. 19/12/2013
TA304/1 NICE recommended that research should be carried out to determine the relationship between activity and prosthesis failure. 13/03/2014
TA304/2 NICE recommended the collection of data on prosthesis failure or on the prevalence of people living with a failed hip but for whom revision surgery is not suitable or who choose not to have revision surgery. NICE further recommended that nomenclature for hip replacement failure needs to be established to allow demarcation of prosthesis-dependent and prosthesisindependent hip replacement failure. Furthermore, patient reported outcome measures collected as part of the National Joint Registry should allow for reporting of hip replacement failure in people who cannot or choose not to have revision surgery. 13/03/2014
TA310/1 NICE recognised the importance of further clinical trials comparing the effectiveness of the tyrosine kinase inhibitors (afatinib, erlotinib and gefitinib) in EGFR mutation-positive locally advanced or metastatic NSCLC. 23/05/2014
TA313/1 NICE considered that there is an important need for head-to-head comparisons between biological treatments for psoriatic arthritis, particularly in people for whom treatment with tumour necrosis factor (TNF) alpha inhibitors has been unsuccessful. 03/07/2014
TA316/1 NICE supports the manufacturer's ongoing commitment to collect data on the effectiveness of enzalutamide after previous treatment with abiraterone. 07/10/2014
TA316/2 NICE considered that if enzalutamide is used in routine clinical practice for treating hormone relapsed metastatic prostate cancer that has been previously treated with abiraterone, data should be collected on resource use and overall survival. 07/10/2014
TA319/1 NICE considered that more research is needed to establish the treatment sequence for vemurafenib and ipilimumab in patients who have BRAF V600 mutation-positive melanoma. 07/10/2014
TA319/2 Further research into whether concomitant dacarbazine enhances the clinical effectiveness of ipilimumab would be encouraged because it could provide information for future treatment strategies, as would more data on the relative effectiveness of ipilimumab when given as a first-line or second-line treatment. 07/10/2014
TA320/1 NICE recommends further research to better inform future cost-effectiveness models of relapsing-remitting multiple sclerosis. In particular, this research should include a more comprehensive synthesis of available evidence on the underlying disease progression of multiple sclerosis in the UK context, the impact of disability and relapses on preference-based measures of quality of life, and associated resource use and costs. 15/10/2014
TA322/1 NICE noted that the cost effectiveness of lenalidomide compared with standard care for people with low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate, was sensitive to whether the patient access scheme would be realised in clinical practice. The Committee agreed that it would be critical to generate evidence to support the following:
- The proportion of people who become eligible for the patient access scheme, that is, that they remain on treatment beyond 26 cycles.
- The benefit of lenalidomide after 26 cycles, that is the associated overall survival and health related quality of life for those who remain on treatment beyond 26 cycles.
15/10/2014
TA330/1 NICE recommended that clinical data, including genotype and sustained virological response at 12 weeks, is collected for all people treated with sofosbuvir in the NHS. 23/04/2015
TA333/1 NICE recommended that clinical data, including genotype and sustained virological response at 12 weeks, are collected for all people having treatment with simeprevir in the NHS. 23/04/2015
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