Rationale and impact

These sections briefly explain why the committee made the recommendations and how they might affect practice and services.

Organising and delivering services

Cancer alliances and commissioners

Recommendations 1.1.1 to 1.1.4

Why the committee made the recommendations

There was conflicting evidence about implementing clinical care pathways, with 1 study suggesting that care pathways improved outcomes and another suggesting they had no clear benefit. Based on their experience, the committee felt a structured, standardised approach to implementing care pathways could still help ensure healthcare professionals understand processes and provide people with better access to services. Therefore, they recommended that every cancer alliance should set up clear care pathways for spinal metastases and metastatic spinal cord compression (MSCC).

The committee also noted that within cancer alliances (or equivalent local partnerships), services, such as diagnostic services to investigate suspected cord compression, need to be available at short notice so that the whole care pathway can be implemented effectively. Services also need to be monitored to ensure they meet people's needs and the standards set (such as the timing for MRI assessments).

Based on their experience and expertise, the committee agreed that within cancer alliances, professionals from all care settings, including representatives from the MSCC service and relevant specialties (for instance, alliance groups for primary tumours), need to work together and involve people with lived experience to implement care pathways effectively and ensure they meet people's needs. Good organisational and clinical leadership, with clearly defined responsibilities, will help ensure services are overseen effectively and are accountable.

How the recommendations might affect services

The recommendations for cancer alliances will help reinforce and standardise current service organisation and oversight.

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Providing a coordinated MSCC and spinal metastases service

Recommendations 1.1.5 to 1.1.14

Why the committee made the recommendations

The committee discussed the evidence on service configuration and the recommendations in the previous guideline, and took into account how practice and services have evolved since the previous guideline published. They also considered a new analysis conducted for this guideline of an audit of all people referred to an MSCC service between January 2018 until the end of May 2022 in the UK Clatterbridge Cancer Centre (covering a population of 2.4 million people across Cheshire, Merseyside, and the surrounding areas).

Based on the previous guideline, the committee reinforced the importance of having dedicated MSCC services in place so that people with spinal metastases or MSCC can be referred and get the coordinated care that they need.

There was new published evidence from a UK-based audit, which coincidentally included evidence from before and after publication of the previous NICE guideline. The previous NICE guideline recommended significant changes to services, paving the way for designated MSCC services and defining the role of the MSCC coordinator. None of the outcomes from the audit related specifically to the role of the MSCC coordinator but the evidence showed there had been some improvement in access to services. The committee agreed that this improvement was most likely due to better coordination of MSCC services and that introducing the MSCC coordinator role had led to better outcomes. This was also consistent with the analysis of the Clatterbridge Cancer Centre audit data, which showed improvements in how long patients lived associated with services that included the MSCC coordinator role. In the Clatterbridge Cancer Centre, staff members were upskilled to carry out this role so that there were multiple MSCC coordinators, and this led to better outcomes.

The committee agreed that having an MSCC coordinator (or a designated person available as the first point of contact) would make referral processes easier and faster. They also noted that, because MSCC is an oncological emergency, cover is needed 24 hours a day, 7 days a week for planning urgent referral, investigations and treatment. They noted that the MSCC coordinator role is a clinical rather than a clerical role and that this would require out-of-hours arrangements whereby a clinician with appropriate expertise would take on this role when the MSCC coordinator is not working (for example, an on-call oncology registrar). Having the MSCC coordinator or the designated clinician with appropriate expertise as a first point of contact also makes the patient pathway more efficient because initial decisions can be made promptly. They noted that coordination of care works best and is most efficient when the initial contact is made through oncology services, ensuring direct access to this specialty, which could speed up triage and planning.

The committee discussed that services may be spread across a number of departments and may not always be co-located, and that there are other services that they also need to be in contact with. They noted that without coordination, care can become disjointed. To remedy this, they recommended that arrangements should be in place to ensure that services are well coordinated.

Based on experience, the committee noted that all MSCC services need to have access to different specialties and would therefore need to operate using a multidisciplinary approach to support decision making and planning of care with individual designated points of contact for each of these (for example, by having a specific phone number for MSCC referrals in relevant specialties).

It was acknowledged that specialist services, such as MSCC services, do not always link up and share information effectively with secondary, community and primary care, which can be detrimental to people's follow up after discharge from hospital. To address this, they agreed that MSCC services should establish links with relevant services to ensure continuity of care.

The committee noted that there is variability in data recording. They agreed that MSCC services should be recording their own data and carrying out audit to support service improvements, which may lead to more effective referral and treatment and improve outcomes.

Based on information related to deprivation in the Clatterbridge Cancer Centre audit data and on the NICE equality impact assessment conducted during scoping of the guideline, the committee discussed related health inequalities, for example, in cancer incidence and mortality in deprived areas, and access to services in more remote geographical locations. The committee agreed that awareness needs to be raised and that the specific health inequalities in a local service may also not always be known, so information should be collected to identify these. This information should then be communicated so that local inequalities can be reduced, where possible, and reasonable adjustments made in line with the Equality Act 2010.

The evidence indicated that continuity of support is potentially at risk when people are discharged from hospital to home. The committee agreed that coordinated care pathways between hospital and community care, and also with social services, can help ensure people can access support after discharge to maintain their independence and quality of life, support self-management and improve their confidence.

How the recommendations might affect services

The committee discussed that the previous guideline set standards for MSCC services. They acknowledged that many MSCC services currently only accept referrals for suspected or confirmed MSCC but not for people with spinal metastases without MSCC. This means that the new recommendations will increase activities significantly with an associated impact on resources. The committee discussed that MSCC services should have spinal oversight and bring together the relevant critical expertise, which would have clinical and survival benefits. The evidence from the economic model based on a service providing full spinal oversight showed that after initial implementation costs, it led to cost savings because it prevented people losing function and maintained their independence. This was confirmed by the economic analysis, which showed that costs decreased per person after the creation of the service and that implementation costs should be regained over the first few years of a newly set up service. The committee noted that many services already provide advice on the treatment of spinal metastases or suspected MSCC so relevant experience already exists that would help implement this. They also noted that the implementation of the MSCC service has evolved since the previous guideline and that basing it within the oncology service will make it more efficient. In addition, people with spinal metastases are currently being referred to services. Expanding the MSCC services to also accept referrals for people with spinal metastases therefore does not represent additional costs to the system, but rather a movement of costs from one service to another. The recommendations will help standardise current practice and improve coordination of the person's pathway through services.

For areas that have not yet fully implemented the MSCC service recommended in the previous guideline, the costs of setting up the service will be large. These costs will include recruiting members of the MSCC team, including coordinators, setting up computer systems for recording patient information and auditing outcomes. There will also be costs incurred by setting up referral pathways and disseminating them to referring centres. This may include site visits or training sessions, which will divert time of attending clinicians away from other tasks. Monitoring and feedback will also be needed during the first few months of the service to ensure that people are being referred with an appropriate level of urgency and in line with the relevant pathways. However, the economic model, which was based on the level of service recommended in the previous guideline being already in place, showed that cost savings increased over the time horizon of the model and so the committee thought that these one-off set-up costs would likely be fully recovered over the first few years of the service operating.

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Roles in a coordinated MSCC and spinal metastases service

Recommendations 1.1.15 to 1.1.18

Why the committee made the recommendations

Based on experience, the committee agreed that services can only run smoothly when roles and responsibilities are clearly defined and therefore listed some of the key tasks that the MSCC coordinator or a senior clinician would be responsible for, the advice that the MSCC service should be able to provide (which could be service-related or clinical advice) as well as the tasks that a senior clinician would be expected to be involved in. The committee noted that the person in the role of MSCC coordinator would have sufficient medical knowledge to give initial advice on topics that are needed in emergencies (for example, pain management and immobilisation). A senior clinician with expertise in diagnosing and managing spinal metastases would then be responsible for developing a personalised care plan, which would require more detailed clinical knowledge and advice from clinicians from relevant specialties. It was also acknowledged that medical emergencies such as MSCC require a senior clinician to be available to give advice at all times to ensure patient safety.

How the recommendations might affect services

The committee discussed that the previous guideline set standards for roles within the MSCC service, but noted that at the moment, most MSCC services accept referrals for people with confirmed MSCC rather than people with suspected MSCC or spinal metastases. This means that the new recommendations will increase activities of the role of the MSCC coordinator significantly and could have an impact on resources. This would include dealing with and coordinating more referrals and giving more initial advice. However, the committee noted that having this early input would also mean that the level of urgency can be more clearly assessed and the service is better coordinated, which would lead to better outcomes. This might mean that existing staff will need to be upskilled to cover this role, which could be achieved by in-house training. Although any formal training costs of upskilling existing staff were not included in the economic model, the committee thought it was likely that downstream savings from implementing a coordinated MSCC service would likely offset any additional training costs.

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Providing urgent imaging and radiotherapy services

Recommendations 1.1.19 to 1.1.21

Why the committee made the recommendations

The committee discussed the evidence related to service configuration, taking into account the recommendations from the previous guideline. The most relevant evidence came from a UK-based audit, which compared outcomes for patients with MSCC in 2012 and in 2018 (data published before and after the previous NICE guideline). It showed there were better outcomes for people in 2018 compared with 2012 when they:

  • had MRI within 24 hours of referral for radiotherapy so that results could be urgently reviewed and discussed with the relevant clinician or

  • had radiotherapy within 24 hours of referral for this treatment.

The committee found there were uncertainties around this evidence but the reported improvements were consistent with their experience, particularly the evidence around urgent MRI assessments and radiotherapy. They recommended that services are organised to enable access to MRI and radiotherapy services within 24 hours for people with suspected or confirmed MSCC so that treatment can be started urgently if needed. Based on experience, the committee also agreed that sometimes immediate treatment is needed, so MRI services should be accessible out of hours. The committee discussed how this could be implemented, for example by using protected, dedicated appointments or rescheduling elective scans.

How the recommendations might affect services

The recommendations about service organisation to enable urgent MRI assessment and radiotherapy treatment will reinforce current practice.

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Providing support and rehabilitation services

Recommendations 1.1.22 to 1.1.28

Why the committee made the recommendations

There was no evidence identified on service configuration for management and early rehabilitation. The committee reviewed the recommendations from the previous guideline and agreed that the standards it set for practice and care should be reinforced and updated to better reflect current best practice.

Drawing on their experience and the recommendations in the previous guideline, the committee recognised that people with MSCC may have social care needs and that services need to work together (for example, community-based nursing liaising with rehabilitation services) to ensure the right services, equipment and support is available in the community after transition from hospital to home.

For some people, specialist rehabilitation is needed. This can be given in different settings, for instance in the community or in hospital. The previous guideline focused solely on admission to specialist rehabilitation units. Although the committee did not want to rule out this option, they decided to broaden the recommendation to all types of specialist rehabilitation because admission to such units is not always necessary. They agreed that decisions about admission to a specialist rehabilitation unit would depend on the person's circumstances, level of function, treatment and likelihood to benefit from this. They decided that they could not be prescriptive about who would most likely benefit from this because it would depend on many different clinical and social factors, and noted that it should be left to clinical judgement.

The committee agreed that discharge planning should include discussing the person's needs and preferences as their care evolves, and involve people important to the person and the relevant specialists. They noted that efficient planning and smooth transition to care at home needs to be coordinated and that this is best achieved by having a named individual to lead on this so that the relevant contacts can be made.

When people return home, the committee acknowledged that they would need support and equipment and that this would need to happen in a coordinated and timely way. They decided that services need to link up and liaise with each other in order to achieve better coordination of support for rehabilitation in the community. The committee also highlighted the importance of support and training for families and carers before discharge to ensure that they are prepared and able to support the person when they return home.

How the recommendations might affect services

The committee agreed that these recommendations reinforce the messages from the previous guideline but that there could still be small variations in practice. The recommendations aim to support full implementation.

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Information and support

Supporting decision making

Recommendations 1.2.1 to 1.2.4

Why the committee made the recommendations

The committee used qualitative evidence, as well as recommendations from the previous guideline and their expertise and experience, to make the recommendations.

The evidence showed that people with suspected or confirmed spinal metastases or MSCC can find it difficult to take in and understand information about their condition and care options, and feel less involved in their care as a result. The evidence also suggested that information was not always tailored to their needs and preferences. They can feel overloaded with large amounts of technical information (especially about prognosis and treatment). The committee made recommendations to improve communication with people with spinal metastases or MSCC and their families and carers so they can be fully involved in decisions about care and support.

Evidence showed that people did not always know who to contact for information and support. The committee also acknowledged that the symptoms of spinal metastases can progress, for example, from back pain to neurological symptoms such as numbness. In such cases, immediate treatment may be needed to avoid neurological impairment. Telling a person and their families and carers who to contact if their symptoms worsen can minimise treatment delays and ultimately may preserve neurological function. Providing contact information can also build trust between the person, their families and carers, and healthcare professionals.

How the recommendations might affect practice

Having discussions about investigations and treatments, and giving opportunities to raise concerns, is not a change in clinical practice. The recommendations clarify the potential content of such conversations in order to standardise practice.

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Providing support

Recommendations 1.2.5 to 1.2.11

Why the committee made the recommendations

The committee used qualitative evidence, as well as recommendations from the previous guideline and their expertise and experience, to make the recommendations.

The evidence showed that people with spinal metastases or MSCC often feel anxious, helpless and in need of emotional support. The committee discussed that it is good practice to carry out a holistic needs assessment to pinpoint the specific needs of each person. This could reduce feelings of anxiety and helplessness, and help the person feel involved and supported. This assessment should take account of the person's needs and preferences (which can be psychological, emotional, spiritual or financial) as well as any other factors that may affect their care, and will ensure tailored care and support that will lead to better outcomes. They noted that there is variation in when holistic needs assessment is carried out, and it often happens at the start of rehabilitation. However, the committee agreed that having this assessment at the earliest possible time would be beneficial, allowing the person's needs and preferences to be taken into account when treatment options are being discussed and revisiting this when needs or preferences change.

The evidence indicated that people with spinal metastases or MSCC and their families and carers often felt distressed, and their emotional needs could change at different points in their care. This could include feeling worried by uncertainty during diagnosis and investigation, or feeling distressed because of pain or changes to their physical function. The committee therefore agreed that people should be advised on how to access support for their psychological, emotional, spiritual and financial needs. The evidence also showed that people wanted more information and support relevant to their circumstances and needs at appropriate times. By encouraging the person to discuss their support needs, healthcare professionals can make sure these are addressed.

The committee discussed the inequalities identified in NICE's equality impact assessment and an analysis of deprivation data from the Clatterbridge Cancer Centre audit. It was noted that many inequalities are public health issues that are not easily resolved by individual healthcare professionals or services. However, they agreed that more feedback should be sought from people about their experience with services so that improvements can be made where necessary and reasonable adjustments can be made so that everyone's needs are met.

There was evidence that people with MSCC wanted information, support and the chance to talk about and plan for the end of life. The committee acknowledged the empowering impact of advance care planning (not restricted to end-of-life care) but also noted that many people with MSCC have a life-limiting condition and advance care planning gives them a way to express their preferences for how they should be cared for in the final months of life. Evidence also showed that their families and carers needed bereavement support, when appropriate, to help them cope with their feelings of sadness and loss.

How the recommendations might affect practice

The use of holistic needs assessments has become common practice since the previous guideline. They are widely used in current practice to ensure person-centred care, and the new recommendations will reinforce this. Advising how to access and, when possible, providing emotional support to people and their families is current practice and the recommendations clarify how and when this could be done to standardise practice. Seeking feedback and discussing people's experience with services is not universally done but the committee felt that it could make people feel included and taken seriously and could help improve services. Based on evidence of what support and information people valued, it also makes practice more directly applicable to people's needs.

Return to recommendations

Support from healthcare services including discharge from hospital

Recommendations 1.2.12 and 1.2.13

Why the committee made the recommendations

The committee used qualitative evidence, as well as recommendations from the previous guideline and their expertise and experience, to make the recommendations.

The evidence showed that people with spinal metastases or MSCC often have ongoing needs as they adapt to life changes and disability, such as reduced mobility. By providing them, and their families and carers, with access to support services for advice, assessment and rehabilitation, they should have the support and help they need to maintain their independence for as long as possible. The committee noted that support and training for families and carers can be variable and highlighted the importance of practical support and training. They identified some of the types of care and equipment that people may need help with to manage at home.

How the recommendations might affect practice

The evidence showed that some people felt that not all of their needs are met when they are discharged from hospital, implying that practice is variable. Therefore, the recommendations will standardise care to improve this.

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Recognising spinal metastases or MSCC

Recommendations 1.3.1 to 1.3.6

Why the committee made the recommendations

Back pain is a common early symptom of spinal metastases and MSCC. The committee were aware of tools that are used for risk assessment in people presenting with low back pain in current practice, so they cross referred to recommendations in the NICE guideline on low back pain and sciatica in over 16s.

Early identification is important to enable early treatment and prevent disease progressing. Evidence was reviewed on symptoms and signs that may support early recognition. This included evidence that compared symptoms in people with metastatic spinal disease with symptoms in people with low back pain due to other causes, and evidence of symptoms of spinal metastases in people presenting with undiagnosed cancer.

The evidence showed that a past or current diagnosis of cancer was a strong indicator that back pain could be a symptom of metastatic spinal disease. Other symptoms that the evidence highlighted related to characteristics of pain and neurological signs and symptoms. The committee used this evidence and their experience to list factors suggesting possible spinal metastases or MSCC that should alert a healthcare professional to think of these conditions and enable early recognition.

The committee agreed that a past or current diagnosis of cancer and any of the neurological symptoms or signs listed should be considered a medical emergency requiring immediate action to prevent the spine becoming unstable. They agreed that this should involve an immediate discussion with the MSCC coordinator to organise emergency care.

The committee noted that currently MSCC services and MSCC coordinators focus on people with suspected or confirmed MSCC rather than people with spinal metastases and that this has led to people presenting late to services. They agreed that advice is needed promptly (within 24 hours) for people with a past or current diagnosis of cancer who present with pain that has characteristics suggesting spinal metastases to ensure that the correct investigations are done with the appropriate level of urgency. They agreed that this should involve a discussion with the MSCC coordinator to organise their ongoing care.

The committee noted that once the condition is suspected, prompt action is needed to prevent progression. They therefore highlighted the areas of advice that may need to be discussed initially with the MSCC coordinator.

The committee discussed that sometimes people who do not have a prior diagnosis of cancer report symptoms and pain characteristics consistent with those listed in box 1 that raise suspicions of cancer, and took into account the NICE guideline on suspected cancer. They decided that in these cases, it is important to urgently refer to oncology services so that cancer is not missed.

Based on their experience and expertise, the committee agreed that information (which is tailored to the person's needs) should be provided to people with a past or current diagnosis of cancer who have back pain without evidence of spinal metastases or MSCC to ensure that they are alert to the risks and know what symptoms to look out for and when to contact their healthcare professional without delay.

How the recommendations might affect practice

In practice, it is hard to distinguish back pain due to other causes from potential spinal metastases. This has resulted in variation in practice. Involving MSCC services and MSCC coordinators in treatment and advice for people with suspected or confirmed spinal metastases is a change for some centres, but the committee decided that this is needed to treat spinal metastases and prevent progression of disease. The committee provided the list of pain characteristics to raise awareness and improve recognition so that actions are taken without delay to prevent serious consequences.

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Immobilisation

Recommendations 1.4.1 to 1.4.4

Why the committee made the recommendations

No evidence was identified on immobilisation, so the committee reviewed the recommendations from the previous guideline and used their expertise and experience to update them.

The committee agreed that people who present with neurological signs and symptoms of spinal instability should have interventions to reduce the spinal load (immobilisation) such as reclined support, either flat or elevated and guided by comfort and assistance because of the risk of damage to an unstable spine. They also agreed that people with pain associated with movement may be at risk of spinal instability (see the section on tools for assessing spinal stability and prognosis) and should also be considered for immobilisation based on clinical assessment of their symptoms.

The committee were concerned that currently some people are immobilised for longer than necessary, lying in a flat position, which has a detrimental impact on their physical and mental wellbeing. The committee discussed that care of the spine needs to be balanced with the needs of the patient and the risk of complications from prolonged bedrest. They agreed that immobilisation could involve lying in a supine position either flat or with partial elevation depending on the person's comfort and preferences. The committee also discussed that for some people, lying supine can be painful or affect their breathing. It was highlighted that the person's position might have to be adjusted to relieve symptoms and improve comfort without risking weight bearing onto the spine.

To avoid people being immobilised for too long, the committee recommended that expert advice on spinal stability should be sought within 24 hours and assessment should be started (see the section on MRI assessment) to determine how long immobilisation may be necessary. The committee gave some examples of who to seek advice from, but noted that they cannot be prescriptive about this because it would depend on the person's individual condition and treatment plan.

Given the lack of evidence and the impact that immobilisation has on a person's quality of life, the committee made a recommendation for research to investigate different forms of immobilisation.

How the recommendations might affect practice

Immediate immobilisation to prevent the spine from collapsing is current practice for people with MSCC. However, this usually involves lying flat. The change to partial elevation could have a positive impact on the person's quality of life. The committee expressed concerns that some people are immobilised for too long, so the recommendation on minimising the duration of immobilisation will standardise good current practice.

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Imaging investigations – radiologist involvement and MRI assessment

Recommendations 1.5.1 to 1.5.6

Why the committee made the recommendations

There was a large evidence base that the committee considered for radiological imaging techniques for the diagnosis of spinal metastases or MSCC. The committee based recommendations on this evidence as well as on their expertise and knowledge.

Radiologist involvement

The committee acknowledged that carrying out radiological imaging of the spine and interpreting the results is complex (for example, selecting the correct sequencing and, if necessary, supplementary axial imaging), and that the impact of errors may have very serious consequences. The committee also thought that there is variation in how urgently results are reported, which can affect starting timely treatment. The committee agreed that imaging should be overseen by a radiologist. The radiologist would not necessarily need to be present for the scans but could virtually oversee imaging and ensure prompt and accurate reporting.

MRI imaging

The committee discussed the evidence related to service configuration that showed that prompt action (within 24 hours) in relation to MRI investigations for MSCC leads to better outcomes. Given that MSCC is an oncological emergency and can lead to the collapse of the spine, they reinforced the message from the last guideline that an MRI scan as soon as possible (and always within 24 hours) is necessary.

The committee noted that delays can sometimes occur due to unnecessary transfer to specialist centres for MRI scans. Such transfers can also be difficult if the person has to be immobilised. To prevent this, the committee recommended that MRI should be performed at the local hospital or at an appropriate centre with direct access to imaging facilities. They noted that transfer to a tertiary centre should be the exception, even if it would mean that local or other appropriate centres may need to interrupt their existing elective scanning lists to accommodate this.

The committee noted that timely MRI assessment is also needed for people with suspected spinal metastases so that a treatment plan can be started promptly. They agreed that this should be done within a week.

The committee noted that MRI scans performed within 24 hours or within 1 week should not need to be performed by out-of-hours services, and that overnight services are difficult to staff and have additional running costs. They therefore recommended that overnight MRI scans are only done in exceptional circumstances when treatment needs to be started immediately.

There was a body of evidence to support the use of MRI in the differential diagnosis of malignant and non-malignant vertebral bone marrow lesions. There was also evidence that T1-weighted sagittal MRI images alone had relatively low sensitivity for spinal cord compression. Based on this evidence, the committee agreed that both sagittal T1 and T2 sequencing should be performed to confirm or exclude spinal metastases and show the level and degree of compression. Based on experience, they also noted that this should usually include axial imaging if an abnormality is found to create a 3D view of tissues so that the metastases can be clearly located.

How the recommendations might affect practice

The recommendations on MRI assessment will reinforce current good practice and standardise imaging. There is variation in where the MRI is performed and the recommendation that this is done at the local hospital, if possible, will prevent unnecessary transfers and save time. Cost, availability and timing of MRI were discussed, but because of the nature of the condition and the need for urgent treatment to prevent major loss of function, the committee agreed that cost and urgency are justified.

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Imaging investigations – other imaging techniques for diagnosis and management

Recommendations 1.5.7 to 1.5.10

Why the committee made the recommendations

There was a large evidence base that the committee considered for radiological imaging techniques for the diagnosis of spinal metastases or MSCC. The committee based recommendations on this evidence as well as on their expertise and knowledge.

The committee acknowledged that there are people who cannot have an MRI scan, for example, those with an aneurysm clip in their brain or any other metal part in their body. They discussed that usually a CT scan would be sufficient to assess the spine and plan treatment for these people. They agreed that myelography could also be an option, but it would result in a delay and carry additional risks. It is an invasive procedure, which should be carried out at a neuroscience or spinal surgical centre because it needs technical expertise and because of the risk of deterioration needing urgent decompression. Therefore, the committee highlighted that myelography should only be carried out if necessary (for example, if clearer information is needed about soft tissue) following a CT scan.

There was evidence that plain X-rays plus neurological assessment had a very low sensitivity for diagnosing spinal cord compression. It was shown that more than half of radiotherapy plans based on plain X-rays with neurological assessment were changed when information from MRI became available. The committee therefore agreed that plain X-rays should not be used for diagnosis.

Evidence from a randomised trial indicated that carrying out screening spinal MRIs for people at high risk of MSCC had no clinically important impact on overall survival, neurological and functional status, pain or quality of life. Based on this, the committee agreed that MRI should not be performed for the early detection of cord compression in people with diagnosed spinal metastases who are asymptomatic for cord compression.

There was no evidence related to radiological imaging techniques to help plan the management. The committee drew on the research identified for radiological imaging techniques in diagnosis as well as on their experience and expertise. They agreed that multiplanar viewing or 3‑plane reconstruction of recent or, if not available, new CT images should be considered to assess spinal stability but also to plan vertebroplasty, kyphoplasty or spinal surgery because, based on their expertise, they noted that it can provide a more precise tumour location, which is needed when planning surgery to avoid making large or multiple incisions to find and remove a tumour.

How the recommendations might affect practice

The committee noted that the recommendations are consistent with current practice and will standardise imaging. The committee discussed whether CT scans could be used alone instead of CT and MRI scanning but the committee agreed that both may be needed for diagnosis and management to ensure the accurate inspection of soft and bony tissue, and to clearly locate the tumour site.

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Mobilisation and assessment of spinal stability

Recommendations 1.6.1 to 1.6.6

Why the committee made the recommendations

No evidence was identified on mobilisation, so the committee reviewed the recommendations from the previous guideline and used their expertise and experience to update them.

If investigations, imaging or clinical assessment indicate that there is likely spinal stability, mobility should be gradually increased so that the person can better engage with their environment and the people around them. To ensure people are thinking about mobilising straight away, and not only following radiotherapy or systemic treatment, they added that mobilisation could start regardless of whether the person has received treatment or not. The committee noted that healthcare professionals need to check the person's blood pressure for orthostatic hypotension and monitor symptoms, such as pain or neurological symptoms, continuously. If there is a significant deterioration in the person's symptoms, they may have to return to a more tolerable position. The committee discussed that a significant increase in symptoms may indicate spinal instability and agreed that reassessment should be carried out.

There are some people for whom treatment may not be appropriate or possible, and it is sometimes assumed that they do not need mobilisation or that it is unsafe. The committee agreed that mobilisation should still be carried out, if possible, to improve the person's quality of life, independence, and interactions with others and their environment.

Based on experience, the committee discussed that some people may benefit from the use of orthoses to promote mobilisation. There was no evidence identified for this, so the committee suggested that specialist advice should be sought if orthoses are considered as an option. The committee did not want to be prescriptive about which specialist would give this advice because this would depend on the person and their condition.

Given that no evidence was identified in this area, and that appropriate and timely mobilisation can have a big impact on the person's quality of life, the committee made a recommendation for research to investigate different forms of remobilisation.

How the recommendations might affect practice

The committee agreed that these recommendations reinforce and standardise current practice.

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Individualised pain assessment and management plan

Recommendations 1.7.1 to 1.7.5

Why the committee made the recommendations

Based on their experience, the committee discussed that pain is often the reason why people seek help, both before and after diagnosis. Immediate action is often needed to coordinate and start investigations and treatment, but the person's pain should not be overlooked and needs to be managed promptly too. To prevent delays to pain management, the committee agreed that adequate and timely pain relief should be provided.

The committee noted that an assessment of all aspects related to a person's pain is needed for effective pain management. They agreed that this would involve a detailed discussion with the person about issues such as the characteristics of the pain and how it affects them in their daily life. The committee highlighted that in current practice, such assessments are not always individualised, for example, focusing on pain scales, and do not take into account the personal experience of pain and different ways of describing their pain, which can mean that people do not feel listened to.

To further strengthen the person-centred approach to pain management, the committee decided that people should have opportunities to discuss their pain management options, what they have tried previously, what they expect from the treatment and raise concerns. Such discussions would allow a shared decision to be made to agree the most acceptable and effective options with the person. The committee listed issues that would be most relevant for this population.

The committee agreed that it is important to assess regularly whether the treatment adequately relieves pain, so they recommended that it should be reviewed after starting and changing treatment. Based on experience, the committee discussed that some people would benefit from specialist pain management services, depending on their pain assessment and the impact the pain has on their life, and agreed that a referral could be made.

How the recommendations might affect practice

The committee noted that there is variation in how pain assessment is carried out and what is discussed with the person. They also discussed that the recommendation related to referral to a specialist pain service may increase demand and increase costs. It was agreed that this was justified because it will improve outcomes for those who have severe pain or pain that significantly affects their activities. The recommendations will standardise assessment and ensure that people are listened to and understood so that they can get the most appropriate pain treatment.

Return to recommendations

Analgesic medication

Recommendations 1.7.6 to 1.7.11

Why the committee made the recommendations

The evidence on pain management was limited, consisting of 3 randomised controlled trials, the largest of which included 60 people with stable spinal metastases. The committee acknowledged that there was not enough evidence for them to make recommendations based on these studies alone, so they drew on their knowledge of the World Health Organization (WHO) guidelines for the pharmacological and radiotherapeutic management of cancer pain in adults and adolescents (2018), as well as related NICE guidelines. They also discussed their own experience and reviewed the recommendation from the previous guideline.

The committee agreed that the adverse effects of analgesic medication can affect quality of life and adherence to treatment, and that the risks are not always fully discussed. They highlighted the importance of these discussions to ensure that people understand the possible risks and benefits of different treatment options and are supported to make decisions about their treatment.

Since the previous NICE guideline, the advice from WHO has changed and they are no longer using the '3‑step pain ladder' previously recommended. The committee agreed that the new recommendations should be in line with the current WHO guidance, which recommends analgesic treatment with non-opiate medicines (for example, paracetamol or non-steroidal anti-inflammatory drugs) and opiate medication as options for initial treatment. The choice of medicine, used individually or in combination, is dependent on the ongoing individualised pain assessment and severity of pain, and agreed with the person in their pain management plan. The committee noted that this is consistent with their experience, reflects current practice and ensures that the medication is tailored to the person's needs.

The committee also discussed that people's responses to pain treatment vary and that it is important not to leave people on a treatment that may not be working or may require a different dosage to achieve effective pain relief. To avoid inadequate pain relief, they recommended that dosage, titration and tolerability are discussed at each review and the management plan updated if necessary.

The committee discussed the use of medicines for neuropathic pain and, based on their knowledge and experience, decided that they could be given if the pain has neuropathic features or opioid analgesia has been ineffective. There was no direct evidence for this identified for people with MSCC so they decided that this should be prescribed in line with recommendations in the NICE guideline on neuropathic pain in adults.

Palliative pain relief for people having strong opioids in palliative care and the safe use of controlled drugs were also discussed as critical issues in cancer pain relief but the committee were aware of other guidelines that are dedicated to these topics and signposted to the NICE guideline on palliative care for adults and the NICE guideline on controlled drugs.

How the recommendations might affect practice

The recommendations reinforce good current practice and support implementation of national and international guidance on pain management.

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Bisphosphonates and denosumab

Recommendations 1.7.12 to 1.7.15

Why the committee made the recommendations

Bisphosphonates

The recommendations on bisphosphonate treatment in the 2008 guideline were retained and the evidence for this will be reviewed in a later update to take into account upcoming patent changes. The committee agreed that the recommendations are consistent with current practice and that retaining them would benefit patients and would not be a safety concern.

Denosumab

Even though the evidence for bisphosphonates and denosumab was not reviewed for this guideline, the committee agreed to cross refer to the related NICE technology appraisal guidance on denosumab because it can be used as an option instead of bisphosphonates for people with bone metastases from breast cancer and from solid tumours other than prostate.

How the recommendations might affect practice

The recommendations are consistent with current practice.

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Corticosteroid therapy

Recommendations 1.8.1 to 1.8.8

Why the committee made the recommendations

The evidence for corticosteroid therapy was limited, originating from 3 small studies, so the committee also took into account the recommendations from the previous version of the guideline and used their expertise and experience to make the recommendations.

The committee noted that the previous recommendations no longer reflected current practice, particularly in relation to giving corticosteroids to all people with MSCC regardless of their symptoms. The committee also discussed that the use of corticosteroids in people with suspected MSCC could reduce the chance of a positive biopsy.

There was some evidence that functional status was improved with dexamethasone, but the studies were too small to draw clear conclusions. The committee noted that this finding was supported by their expertise and experience. They agreed that for people with cord compression with neurological symptoms or signs, corticosteroids can reduce inflammation and promote stabilisation of blood vessel membranes at the compression site, consequently reducing back pain and neurological deficits. The evidence also showed an increase in treatment-related toxicity but numbers in the trial were small so there was some uncertainty in these findings. The committee also agreed that, because of potential toxicity and other side effects, corticosteroids should be stopped once other treatment options, such as surgery or radiotherapy, are available. In such instances, corticosteroids should be reduced gradually because a sudden withdrawal may cause adverse events, such as a sharp fall in blood pressure, and affect blood glucose levels. If spinal metastases or MSCC is ruled out, dexamethasone given before imaging should be discontinued because of the potential for adverse events. The duration of corticosteroid use would be short so they can be stopped without reducing the dose.

The committee decided that it was important to make separate recommendations for haematological malignancy. Based on their expertise, the committee agreed that dexamethasone is beneficial for people with confirmed haematological malignancy with infiltration of the spinal column or canal, regardless of whether they have neurological symptoms. Corticosteroid treatment is commonly used for treating myeloma once a haematological malignancy is confirmed (which the committee acknowledged is in line with the NICE guideline on myeloma). The committee agreed that a 16 mg dose of oral dexamethasone (or equivalent parenteral dose) to start with is current practice, but were aware that in some cases, a different corticosteroid or a different dose may be used, so they recommended that ongoing treatment should be discussed with the specialist haematology team.

The committee discussed that corticosteroids should be avoided if a haematological malignancy is suspected but has not been confirmed, because of the potential for a direct anti-tumour effect on B-cell lymphoma causing a reduction in MRI abnormalities, and making biopsy and histologic confirmation more difficult. Therefore, based on experience and expertise, the committee agreed that in these cases, specialist haematological advice would be needed before corticosteroid treatment is started.

The committee agreed, based on their knowledge and expertise, that toxicity is a problem, particularly if dexamethasone is given longer term. They therefore recommended that it should not be used for people without neurological symptoms except where it is part of a radiotherapy regimen. However, they agreed that it could be considered if the person has severe pain or the person has a haematological malignancy (see above).

In situations where there are no other treatment options (because they have been tried and were not effective, the person is too unwell to tolerate other treatment, or giving another treatment is too risky) and symptoms return or worsen as dexamethasone is reduced, the committee agreed that it could be considered for longer.

Increased blood glucose is a side effect of corticosteroid treatment, so the committee recommended blood glucose monitoring. They agreed that a proton pump inhibitor should also be prescribed to reduce the potential risk of peptic ulcer associated with corticosteroid therapy. They acknowledged that glucose monitoring and giving adjunct proton pump inhibitor treatment is common practice but agreed that they are important issues to highlight.

How the recommendations might affect practice

The committee agreed that the recommendations reflect good current practice.

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Tools for assessing spinal stability and prognosis

Recommendations 1.9.1 to 1.9.3

Why the committee made the recommendations

The committee considered the evidence as well as using their knowledge and experience to make the recommendations.

There were only 2 studies of scoring systems to assess spinal stability, both using the Spinal Instability Neoplastic Score (SINS). The evidence showed that it was effective at ruling out instability, but the number of false-positive results was relatively high at the usual threshold. There was also some uncertainty about the quality of the evidence.

The committee discussed that scoring systems can be helpful additions to clinical assessment, especially for less experienced clinicians, ensuring that the main features for determining spinal instability are assessed. They also allow assessments to be standardised, documented and audited.

Although the evidence was limited to SINS, the committee were aware of other systems used in current practice. They included SINS as an example, but did not want to discourage the use of other validated scoring systems already in use or in development.

There was a large amount of evidence for many different prognostic scoring systems, including original and revised versions for some. Analysis showed that these varied in their ability to predict survival, and none of the systems reviewed were better overall at predicting prognosis. The committee noted that, although the Tokuhashi (and the revised Tokuhashi) scoring system was less accurate at predicting short-term (under 6 months) to medium-term (6 to 12 months) survival, it was better than other tools at predicting longer-term prognosis (over 12 months). The committee did not want to be too prescriptive about using a particular scoring system so they gave the revised Tokuhashi scoring system as an example, but they agreed that other validated scoring systems with evidence of accuracy could be used.

The committee wanted to encourage the use of scoring systems that demonstrated good accuracy (both calibration and discrimination) to encourage a more standardised approach to assessing survival. However, because of the lack of certainty, they agreed that treatment decisions should not be based solely on a prognostic score. The evidence showed that many people lived both longer and shorter than predicted, particularly for short- to medium-term survival. To ensure fair access to treatments, the committee agreed that a broader, individualised assessment should be used that includes other prognostic factors alongside a scoring system.

The committee noted that scoring systems have an important role in determining prognosis and informing decisions about treatment (both oncological and surgical). However, such decision making is complex and many other factors need to be taken into account. The committee agreed that scoring systems should not be used in isolation but could help support decision making alongside other clinical factors and patient preferences.

How the recommendations might affect practice

The recommendations reinforce current practice, which takes into account multiple sources of information, such as clinical assessment and results from investigations, as well as scores from validated scoring systems to inform decisions about treatment.

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Radiotherapy and fertility

Recommendation 1.10.1

Why the committee made the recommendation

The committee took into account the recommendations from the previous version of the guideline and their expertise and experience to make the recommendation.

The committee agreed that the impact on future fertility of both the cancer and the radiotherapy treatment should be discussed with the person and, if appropriate (for example, depending on age and preferences), a referral should be made to a fertility specialist. The committee discussed that treatment of MSCC is usually urgent and fertility treatment can take time to organise and undertake in practice. Therefore, it is important to note that MSCC treatment should not be delayed awaiting further discussions with a fertility specialist. It was also acknowledged that radiotherapy fields for MSCC would usually not affect the gonads, so urgent radiotherapy treatment might not have as much of an impact on fertility as for other cancers.

How the recommendation might affect practice

The committee agreed that the recommendation reflects current practice.

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Radiotherapy to treat painful spinal metastases and prevent MSCC

Recommendations 1.10.2 and 1.10.3

Why the committee made the recommendations

The committee discussed the evidence and also took into account the recommendations from the previous version of the guideline and their expertise and experience to make the recommendations.

The evidence showed that for treating painful spinal metastases (with no evidence of MSCC), 8 Gy single fraction radiotherapy was as effective as multiple fractions in terms of pain reduction, spinal stability and overall survival, and it had fewer treatment-related adverse events. The committee agreed that it should be offered in preference to multiple fraction radiotherapy.

There was also evidence from a randomised controlled trial showing that stereotactic ablative body radiotherapy was more effective than conventional radiotherapy in reducing pain for people with spinal metastases without MSCC. This would deliver a precise dose while sparing damage to healthy tissue. Even though the evidence was limited, the committee agreed that this could be an option for people with a good overall prognosis because the evidence showed that it was safe and effective. They also discussed that those with limited metastatic disease (currently up to 3 discrete metastases would be considered standard for oligometastases in accordance with NHS commissioning of stereotactic ablative body radiotherapy) could benefit from this. They agreed that this number would balance the potential that all cancer sites could be controlled with an acceptable level of toxicity.

The committee discussed that there is a lack of awareness about the risks of radiotherapy for haematological spinal metastatic disease and the potential for reducing the success of stem cell harvesting. Depending on the dose, radiotherapy in the lower lumbar or pelvic area can be toxic and compromise haemopoietic stem cell collection. The committee agreed that a discussion with a relevant specialist (pain specialist or haematologist) should take place if radiotherapy is considered for people with haematological disease.

How the recommendations might affect practice

The committee discussed that stereotactic ablative body radiotherapy is not currently made available for painful spinal metastases and would be a challenge to implement initially because new pathways for this would need to be established. However, all centres have access to this technology because it is used in the treatment of other cancers (such as lung cancer) and, once pathways are organised, this would not have a significant resource impact.

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Radiotherapy to treat MSCC

Recommendations 1.10.4 to 1.10.6

Why the committee made the recommendations

The committee discussed the evidence and also took into account the recommendations from the previous version of the guideline and their expertise and experience to make the recommendations.

Although there was no evidence on the timing of radiotherapy, the committee agreed that MSCC is an oncological emergency and rapid access to radiotherapy is needed to prevent neurological impairment. They also agreed that the previous guideline set a benchmark of 24‑hour access to radiotherapy 7 days a week, and changing this would lower the standard of care for people needing emergency treatment for MSCC. The committee discussed that radiotherapy is likely to prevent further neurological damage in people who have MSCC that is unlikely to be suitable for spinal surgery. They therefore recommended it as an urgent option in such situations. However, they decided that it is not likely to be beneficial for people with MSCC and complete tetraplegia or paraplegia (for 2 weeks or longer) whose pain is controlled or for people whose overall prognosis is considered to be poor, because the benefits would be outweighed by the side effects of the radiotherapy.

The evidence showed that single fractionation was as effective as multiple fractions, and the committee agreed that it provides a better patient experience, is more convenient and lower in cost. Avoiding multiple unnecessary hospital visits can be particularly important for people with reduced life expectancy. The studies all used an 8 Gy fraction and therefore the committee recommended this because it was shown to be safe and effective.

The committee were concerned about the increased risk of long-term side effects associated with treating a large volume of spinal cord with a single dose of radiotherapy, for example, when treating a large treatment field or fields. This may also be a concern when retreatment with radiotherapy is being considered. There is no clear definition of a large volume or treatment field and the committee agreed that this should be decided using clinical judgement. In these circumstances, multiple fraction radiotherapy would be appropriate.

In the absence of evidence related to stereotactic ablative body radiotherapy for the treatment of MSCC, the committee could not comment on its effectiveness but made a recommendation for research to compare postoperative stereotactic ablative radiotherapy with postoperative standard radiotherapy.

How the recommendations might affect practice

The committee acknowledged that recommending single rather than multiple fraction radiotherapy was a change to current practice. They agreed that this would improve the efficiency of services and would be cost saving because it would avoid multiple hospital visits and therefore also reduce costs while being equally safe and effective.

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Radiotherapy for asymptomatic spinal metastases

Recommendation 1.10.7

Why the committee made the recommendation

There was no evidence on the use of radiotherapy for people with asymptomatic spinal metastases, so the committee made recommendations based on their experience. They agreed that the adverse effects of radiotherapy would outweigh the potential benefits of the treatment and that it should only be considered in the exceptional circumstances listed: for those in a randomised trial with the intention of preventing MSCC, those with limited metastatic disease (currently up to 3 discrete metastases would be considered standard for oligometastases in accordance with NHS commissioning of stereotactic ablative body radiotherapy) and where radiotherapy could be used to control disease, and for those with radiological signs of spinal cord compression by an epidural or intradural tumour (where radiotherapy may prevent progression to symptomatic MSCC).

How the recommendation might affect practice

The committee discussed that the recommendation is consistent with current practice.

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Postoperative radiotherapy and further radiotherapy treatment

Recommendations 1.10.8 to 1.10.10

Why the committee made the recommendations

Postoperative radiotherapy treatment

The committee discussed the evidence that radiotherapy and surgery had an important benefit over radiotherapy alone in relation to neurological and functional status. Based on this, the committee recommended that postoperative radiotherapy should be offered for spinal metastases or MSCC. This should happen after the person has recovered from surgery for spinal metastases or MSCC, which is important to prevent adverse effects from radiotherapy such as wound breakdown and consequent infection.

Further radiotherapy treatment

No evidence was identified on further courses of radiotherapy after initial treatment, so the committee made recommendations based on their experience. They decided to highlight some of the factors that should be taken into account when making decisions about whether or not to offer further radiotherapy treatment.

How the recommendations might affect practice

The recommendations are consistent with current good practice. Postoperative radiotherapy is commonly given in current practice and the recommendation will reinforce this.

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Timing of invasive interventions

Recommendations 1.11.1 to 1.11.5

Why the committee made the recommendations

Based on experience, the committee noted that there are many different factors to consider that may impact the success of surgical interventions. These include overall fitness for surgery, but also prognosis and issues related to primary cancer type and stage. To ensure that all relevant information is taken into account and to make decisions more efficient, the committee recommended that discussions should take place before surgery is offered, between people from the appropriate specialties within the multidisciplinary team in the MSCC service. This would usually include the oncologist and spinal surgeon but could also draw on other people's expertise where necessary.

The committee discussed, based on experience, that people are sometimes referred to MSCC services without a known primary cancer type. Establishing this could make a difference to management plans, so the committee agreed that a radiologically guided biopsy should be performed in this situation as long as an intervention is not needed immediately.

There was no evidence about different timing of treatments, but the committee recognised that timing is important to prevent neurological decline. They agreed that surgery should be carried out as soon as possible. They decided not to be too prescriptive about exact timeframes because there is variation in how much information is needed and available to come up with a clear surgical treatment approach. However, they agreed that speed of onset and rate of progression of neurological symptoms and signs would be an indicator of urgency.

The committee discussed that in current clinical practice some clinicians use a time limit from onset of paralysis as the only factor to make decisions about whether to offer surgery to people with complete tetraplegia or paraplegia. They noted that this was not evidence-based and that it is not impossible for some paralysis to be reversed even if some time has already passed.

How the recommendations might affect practice

There is variation in who is making decisions about surgery and whether or not this would involve other specialties than spinal surgery. The committee agreed that having joint discussions about surgical treatment plans would make the treatment more tailored to the individual and therefore more efficient and likely to improve outcomes. The recommendations related to timing of surgical interventions reflect current practice and will standardise it.

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Options for invasive interventions

Recommendations 1.11.6 to 1.11.9

Why the committee made the recommendations

Options for invasive interventions depend on whether there is cord compression or not, and there was some evidence relating to interventions for both of these groups. The committee considered clinical evidence, published economic evidence and a new economic model when drafting the recommendations. The evidence was related to very specific populations and mainly compared different types of surgery, making it hard to apply to the whole population. The committee therefore also drew on their expertise and experience.

The economic evidence and economic model only found vertebroplasty and kyphoplasty to be cost effective in some circumstances. However, given that these interventions are used to prevent serious adverse events, including collapse of the spine, the committee agreed that they could be considered if appropriate.

Interventions to treat spinal metastases without MSCC

Most of the evidence did not favour one technique over another for people without cord compression. This was consistent with the committee's experience that clinical judgement is important and there are many factors that may determine which specific technique would be used (for example, level of spinal instability or tumour size). The committee therefore decided to recommend a choice of possible interventions that may be suitable depending on the characteristics of the person's condition.

There was no evidence related to the prevention of MSCC for people with spinal metastases without pain or instability, so the committee decided to make a recommendation for research on surgery to prevent MSCC to address this.

Interventions to treat spinal metastases with MSCC

The evidence on the most effective surgical procedure to treat MSCC was inconclusive. Based on experience, the committee noted that there are only 2 interventions that can be considered. Depending on the person's condition and clinical judgement, surgery would focus on decompression or stabilisation of the spine.

Based on experience, the committee recommended stabilisation surgery when there is cord compression with suspected or confirmed instability with mechanical pain that is not controlled by analgesia and the person is able to have surgery and it is suitable for them (meaning that it would improve prognosis and quality of life). They agreed that it should be carried out even if the person has severe neurological deficit because it is an oncological emergency to prevent the spine becoming more unstable.

If surgery cannot be performed because of the prognosis or other factors, the only other possibility of stabilisation is external spinal support to attempt to prevent collapse of the spine. No evidence was identified for this but the committee decided that this would be the only option available and should be offered.

How the recommendations might affect practice

The committee discussed that there is variation in practice, but this is due to differences in the characteristics of the condition that are being treated. However, the committee agreed that the recommendations would be consistent with current practice and give clinicians the tools to tailor their surgical approach to each person.

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Rehabilitation and supportive care

Recommendations 1.12.1 to 1.12.5

Why the committee made the recommendations

The committee discussed the recommendations on service configuration for support and rehabilitation and how they would be implemented in practice. They also reviewed the recommendations in the previous guideline.

Based on their experience, the committee noted that for rehabilitation to be effective, it needs to be supported by a full range of support services and be considered at the earliest opportunity so that people have a plan in place to regain function after treatment, based on their own preferences, priorities and goals.

The committee agreed that specialist rehabilitation should be offered if needed and could include admission to a specialist rehabilitation unit depending on the person's circumstances, level of function, treatment and likelihood to benefit from this. They decided that they could not be prescriptive about who would most likely benefit from this because it would need to be based on clinical judgement taking into account many different clinical and social factors.

The previous guideline included recommendations on preventing and managing complications; however, these are covered in more detail in other NICE guidance, so cross references have been included.

How the recommendations might affect practice

The recommendations are consistent with current good practice.

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  • National Institute for Health and Care Excellence (NICE)