2 Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.

2.1 Medication review in children – suboptimal use of medicines and medicines-related patient safety incidents

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?

The research should be carried out in children that use services where medication reviews can be carried out.

Study methodology can be based on other well‑conducted randomised controlled trials (RCTs) that have been carried out in adults, the difference being the age of the population. Approval from ethics or other committees would be needed given the young age of the population. 'Usual care' or other interventions would be used as a comparator. 'Usual care' would need to be defined in the study. A follow‑up period of 1–2 years or more would capture longer‑term outcomes. The outcomes for this research question should be patient‑centred and include suboptimal use of medicines, medicines‑related patient safety incidents, patient‑reported outcomes, clinical outcomes, medicines‑related problems, health and social care resource use and cost effectiveness.

The study would need to take into account:

  • the type of medication review carried out; the study needs to outline a framework of the medication review to help guidance developers to see the process used; they would then be better able to decide if it would affect clinical effectiveness of the intervention

  • the health professional carrying it out

  • child, parent and carer involvement as this may affect some outcome measures, depending on their engagement level

  • the frequency of medication review (this would impact on cost effectiveness of resource use).

Rationale

The GDG recognised that the key focus of the medicines optimisation agenda is to make care person‑centred. In line with this and to ensure the best use of NHS resources, the GDG agreed that research needs to be carried out in children to identify the benefit from them having medication reviews. There may be some longer‑term gains with this approach, as from a young age the child would become more aware of the intervention, develop a relationship with the health professional and be encouraged to understand their medicines.

Research into this area will provide guidance to organisations who may want to, or already provide, medication reviews as part of their care and enable better use of resources (for example, health professional cost and time and health and social care resources). This information would be useful to commissioners who may consider whether or not to commission providers to carry out medication reviews.

Proposed format of research recommendations

Criterion

Explanation

Population

Children (this may also involve parents or carers where appropriate) taking medicines for 1 or more clinical condition(s) in the UK.

Intervention

Medication reviews.

Defined in the review protocol as: 'a structured, critical examination of a patient's medicines with the objective of reaching an agreement with the patient about treatment, optimising the impact of medicines, minimising the number of medication‑related problems and reducing waste'.

The framework of the medication review should be outlined in the method of the study.

The medication review can be professional led or carried out by a multidisciplinary team.

Comparator(s)

'Usual care' such as people who may not have a medication review or may have an 'ad hoc' review of their medicines. This may be provided in all settings.

Other interventions, such as another type of medication review.

Outcome

The following outcomes should be considered:

  • suboptimal prescribing

  • medicines‑related patient safety incidents

  • patient‑reported outcomes (for example, patient satisfaction and medicines adherence)

  • quality of life

  • clinical outcomes

  • medicines‑related problems (for example, medication errors)

  • health and social care resource use.

For results to be valid and reliable, outcomes should ideally be measured using validated tools, and where this is not possible the outcome measure should be detailed in the study.

Quality of life should be assessed using an EQ–5D questionnaire so that a cost–utility analysis can be conducted.

Study design

Randomised controlled trial.

Timeframe

Follow‑up outcomes of 1–2 years or more. This will enable assessment on the clinical and economic impact of medication reviews on long‑term conditions and associated outcomes.

2.2 Medication review – suboptimal use of medicines and patient‑reported outcomes

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?

The study should consider the cost effectiveness of the health professional(s) carrying out the medication review.

The medication review should be carried out by a multidisciplinary team or be professional led by any health professional other than a community or hospital pharmacist to provide data to develop an economic model for cost effectiveness. There is already economic evidence available for community and hospital pharmacists.

Research can be carried out using an RCT. Study methodology can be based on other well‑conducted RCTs that have been carried out looking at medication reviews. 'Usual care' or other interventions would be used as a comparator. 'Usual care' would need to be defined in the study. A follow‑up period of 1–2 years or more would capture longer‑term outcomes. Outcomes for this research question should be patient‑centred and include the suboptimal use of medicines, patient‑reported outcomes, clinical outcomes, medicines‑related problems, health and social care resource use and cost effectiveness.

The study would need to take into account:

  • the type of medication review carried out; the study would need to outline a framework of the medication review to help guidance developers to see the process used; they would then be better able to decide if it would affect clinical effectiveness of the intervention

  • type of health professional carrying out the medication review

  • the frequency of medication review (this would impact on cost effectiveness of resource use).

Rationale

The GDG recognised that the key focus of the medicines optimisation agenda is to make care person‑centred and to have services that support people in the optimal use of their medicines. Medication reviews can be offered to people by different health professionals at different levels, working in different settings. Resources (for example, staff and time) needed to enable routine medication review may vary locally depending on the setting and health professional availability.

Research into this area will provide guidance to organisations who may want to, or already provide, medication reviews as part of their care and enable better use of resources (for example, health professional cost and time and health and social care resources) and facilitate service delivery. This information would be useful to commissioners who may consider whether or not to commission medication reviews by providers.

Proposed format of research recommendations

Criterion

Explanation

Population

Children and adults taking medicines for 1 or more clinical condition(s) in the UK.

Intervention

Medication reviews.

Defined in the review protocol as: 'a structured, critical examination of a patient's medicines with the objective of reaching an agreement with the patient about treatment, optimising the impact of medicines, minimising the number of medication‑related problems and reducing waste'.

The framework of the medication review should be outlined in the method of the study.

Carried out by health professionals (including primary care pharmacists) other than community or hospital pharmacists.

Carried out by a multidisciplinary team that can involve any health professional.

Comparator(s)

'Usual care' such as people who may not have a medication review, or may have an 'ad hoc' review of their medicines. This may be provided in all settings.

Other interventions, such as:

  • another type of medication review

  • a review carried out by health professionals other than those specified in the intervention, for example a nurse rather than a doctor.

Outcome

The following outcomes should be considered:

  • suboptimal prescribing

  • patient‑reported outcomes (for example, patient satisfaction and medicines adherence)

  • medicines‑related patient safety incidents

  • quality of life

  • clinical outcomes

  • medicines‑related problems (for example, medication errors)

  • health and social care resource use.

For results to be valid and reliable, outcomes should ideally be measured using validated tools; where this is not possible the outcome measure should be detailed in the study.

Quality of life should be assessed using an EQ–5D questionnaire so that a cost–utility analysis can be conducted.

Study design

Randomised controlled trial.

Timeframe

Follow‑up outcomes of 1–2 years or more. This would enable assessment on the clinical and economic impact of medication reviews on long‑term conditions and associated outcomes.

2.3 Clinical decision support systems

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?

Randomised controlled trials should consider the use of clinical decision support systems to improve outcomes and safety for medicines in the UK setting compared with usual care. A follow‑up period (ideally longer than 2 years) would capture longer‑term outcomes. Outcomes for this research question should include patient‑reported outcomes, clinical outcomes, medicines‑related problems and cost effectiveness. The research can be carried out in all populations that use services where clinical decision support systems can be used. The research could also look at process measures for using clinical decision support systems, for example the clinical effectiveness of such systems can depend on the end users of the system and their interpretation of the active information provided on the screen.

Rationale

Clinical decision support systems (defined as 'an active, computerised intervention that occurs at the time and location of prescribing, to support prescribers with decision‑making') are widely used in some primary care settings, such as in GP practices, but they may also be used in secondary care (in specialist units, for example renal units). There are many types of clinical decision support system available and they vary, from providing clinical decision support for general medicines use to highlighting specific drug interactions. As different types of clinical decision support systems are used already in some UK healthcare settings, the GDG agreed that research needs to be carried out to identify whether using clinical decision support systems is a clinically and cost effective intervention to reduce the suboptimal use of medicines and improve patient outcomes from medicines compared with usual care, in the UK setting.

Proposed format of research recommendations

Criterion

Explanation

Population

All people taking medicines.

Intervention

Clinical decision support systems.

Defined in the review protocol as 'an active, computerised intervention that occurs at the time and location of prescribing, to support prescribers with decision‑making'.

Comparator(s)

Usual care.

'Usual care' in the primary care setting, for example in a GP practice, uses clinical decision support systems which may highlight for example choice of formulary medicines or drug interaction to the prescriber, however 'usual care' in secondary care settings may be different when such clinical decision support systems may or may not be available to use.

Outcome

The following outcomes should be considered:

  • patient‑reported outcomes (for example satisfaction, medicines adherence)

  • quality of life

  • clinical outcomes

  • medicines related problems (for example adverse drug reactions).

An appropriate length of follow‑up would be 2 years or more for the outcomes to be externally valid.

Process measures may also be considered for this research question to see what impact clinical decision support systems have on the training on use of systems, updating systems, and 'alert fatigue'.

Study design

Randomised controlled trial.

Timeframe

Follow‑up outcomes of 2 years or more.

2.4 Cross-organisational working

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?

Randomised controlled trials should consider models of cross‑collaborative working to improve outcomes and safety for medicines, in the UK setting, compared with usual care. A follow‑up period (ideally longer than 2 years) would capture longer‑term outcomes. Outcomes for this research question should include patient‑reported outcomes, clinical outcomes, medicines‑related problems and cost effectiveness. The research should be carried out in all populations that use services across different sectors – for example, care (relating to the use of medicines) of people may be transferred from an NHS organisation to social care, from a secondary care organisation to primary care or within secondary care – for example, from one ward to another. The research could also identify benefits and challenges of cross‑organisational working for suboptimal prescribing of medicines.

Rationale

The GDG was aware of pockets of good practice that involve models of care consisting of cross‑organisational working relating to medicines. However, no published evidence was found to show whether or not it improves patient‑reported outcomes in relation to suboptimal prescribing. This research recommendation will help to provide evidence on whether or not cross‑organisational working is a cost‑effective model of care when improving patient‑reported outcomes for suboptimal prescribing.

Proposed format of research recommendations

Criterion

Explanation

Population

All people taking medicines using the following care settings:

  • NHS

  • social care

  • pharmaceutical industry

  • home care companies

  • private providers of healthcare services.

Intervention

Model used to deliver cross organisational working, for example between NHS and social care, or primary and secondary care, or NHS and commercial organisations; working together using a model to deliver a service collaboratively for medicines.

Comparator(s)

Routine care or usual care.

Outcome

The following outcomes should be considered:

  • patient‑reported outcomes (for example satisfaction, medicines adherence)

  • quality of life

  • clinical outcomes

  • medicines‑related problems (for example adverse drug reactions, medicines discrepancies on records).

An appropriate length of follow‑up would be 2 years or more for the outcomes to be externally valid.

Process measures may also be considered for this research question to see what impact cross‑collaborative working has on resources such as time and staffing. Process measure outcomes may include:

  • time required to transfer medicines‑related information from one care setting to another

  • training of staff required to solve any medicines‑related queries.

Study design

Randomised controlled trial.

Timeframe

Follow‑up outcomes of 2 years or more.

  • National Institute for Health and Care Excellence (NICE)