Evidence reviews for service configuration and delivery – investigations

Included studies

Four observational studies were included for this review, all 4 were retrospective cohort studies (Crnalic 2013, McGivern 2014, Mattes 2020, Pease 2004).

The included studies are summarised in Table 2.

One study compared outcomes according to referral source (Crnalic 2013), two studies compared outcomes before and after implementation of a care pathway (Mattes 2020, Pease 2004), and 1 study assessed compliance with guidance from the Royal College of Radiologists at two time points (McGivern 2014).

Two studies were conducted in the United Kingdom, 1 was conducted in Sweden, and 1 was conducted in the United States.

For the related review of clinical evidence and economic model on service configuration and delivery for management and early rehabilitation see evidence review B.

See the literature search strategy in appendix B and study selection flow chart in appendix C.

Excluded studies

Studies not included in this review are listed, and reasons for their exclusion are provided in appendix K.

Included studies

A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.

A single economic search was undertaken for all topics included in the scope of this guideline. See supplement 2 for details.

Excluded studies

Economic studies not included in this review are listed, and reasons for their exclusion are provided in supplement 2.

The outcomes that matter most

Overall survival, quality of life, patient satisfaction and neurological and functional status were chosen as critical outcomes. This is because efficient referral and care pathways should lead to quicker diagnosis and treatment of metastatic spinal disease leading to better patient outcomes. Emergency admission to hospital and length of stay were important outcomes because an inefficient or delayed referral pathway could increase emergency hospital admissions and result in longer hospital stays. Access to services was chosen as an important outcome to capture service availability in terms of geographic location and waiting times for services. Different configurations (for example centralised versus local) mean that patients may have to travel or wait longer for services.

The quality of the evidence

The quality of the evidence was assessed using GRADE, with all outcomes being rated as low or very low quality. This was predominately due to a very serious overall risk of bias in the studies which contributed to each outcome (mainly due to the risk of confounding), and serious or very serious levels of imprecision in the effect estimates.

No evidence was identified which evaluated the impact of different service configuration and delivery systems on quality of life, patient satisfaction, time to paralysis, or emergency admission and length of hospital stay. Even though the evidence was mainly low quality the committee decided that some of the studies were directly applicable to the UK context using data from audits that compare services for example pre and post implementation of the previous NICE guideline (McGivern 2014) and an audit of an MSCC service that was implemented in accordance with the previous guideline and has since evolved to bring in further refinements which showed steady improvements in length of survival over time (audit of the Clatterbridge Cancer Service - see evidence report B for the related clinical and economic evidence). They therefore gave this evidence more weight in their discussion but also used their expertise and experience and considered recommendations from the previous guideline.

Benefits and harms

The committee discussed that the previous guideline set service configuration standards for care with some detailed recommendations about how they should function. The guideline also led to a NICE quality standard for MSCC which featured service configuration as an important driver for improvements in MSCC care with 2 standards relating to the importance of the role of the MSCC coordinator (statements 4 and 5 - Metastatic spinal cord compression in adults – QS56) and two studies referring to the timing of MRI (statements 2 and 3 - Metastatic spinal cord compression in adults – QS56). The committee agreed that these standards ought to be maintained and improved upon where variation still exists. They therefore used the previous guideline’s recommendations as a starting point for their discussion.

Providing a coordinated MSCC service

There was some evidence that referral pathways were associated with better outcomes particularly related to quicker access to services. Whilst it was not clear in the evidence which exact part of the pathway was driving the faster access to services the committee discussed their experience of the care of people with suspected or confirmed spinal metastases or MSCC and that it requires clear pathways and services to address the complex nature and needs of people with the condition. They noted that the evidence was low quality but agreed that having an MSCC service is consistent with previous guidance which set important standards. However, they noted that many such services currently only accept referrals for suspected or confirmed MSCC rather than spinal metastases. Due to this wider group than in the previous guideline the committee recommended that referrals should be made to this service with an appropriate level of urgency (as described in other recommendations related to other evidence reviews – see for example evidence review D for a discussion on timings around recognition) so that services are not overwhelmed. They noted the number of different specialties that have to be involved in the person’s care and that access to all of the different investigations and referral to specialties requires one coordinated service to address the person’s needs, deal with emergency situations and prevent serious adverse events. They agreed that this can only be achieved if a service is well organised and coordinated. Therefore they decided that there has to be an MSCC service and that it needs to be clear how to refer into it so that people with suspected or confirmed spinal metastases, direct malignant infiltration (DMI) of the spine or MSCC receive prompt diagnosis and treatment in a coordinated way. The committee noted that it is particularly important that referral processes into an MSCC service are clear because this is where delays can lead to serious adverse outcomes. So, they decided to specifically highlight referral processes which is an addition to what was in previous guidance and should improve care.

They discussed that have a designated person as the first point of contact is also very important for the MSCC service. This would be the MSCC coordinator or a designated senior clinician. They acknowledged that usually there would only be one MSCC coordinator in most services and therefore when the MSCC coordinator is not working it would usually be the responsibility of a designated clinician with appropriated expertise to carry out this role. They discussed that some knowledge of cancer or MSCC would be needed so usually that would be an on-call oncology registrar, but they decided to give this as an example rather than being prescriptive about this. This would ensure that referrals into the service and coordination of care within the service take place as promptly and efficiently as possible. Some evidence from a UK audit before and after NICE’s 2008 recommendation (which introduced the role of the MSCC coordinator) showed an improvement in access to services with shorter delays to MRI diagnosis and radiotherapy or surgical treatment. The committee noted that there are uncertainties in the evidence because improvements could be a result of many different components of a service. However, they decided that the coordinator role is particularly important to help the person with the condition and the healthcare professionals treating them to navigate the care pathway. Based on their experience of services and how they have evolved and improved since the previous guideline, they recommended that the designated contact is based in the oncology service, as direct access to this speciality can help to minimise delays in triage and treatment planning. The committee agreed that this has clear advantages with ease of access to expertise and knowledge related to a person’s primary tumour and prognosis so that this information can then be disseminated quicker to other specialties that are also involved in the MSCC care pathway.

In line with the previous guideline and based on their experience and knowledge of services in which the role of the MSCC coordinator has become an important part (including the Clatterbridge Cancer service - see the de novo analysis of the audit data in evidence report B), the committee agreed to recommend that each MSCC service should ensure that the role of the MSCC coordinator is covered at all times (24 hours a day, 7 days a week) which would be carried out by the designated clinician with appropriated expertise to carry out this role when the MSCC coordinator is not working.

The committee acknowledged, based on experience, that there is still variation in practice in relation to how the coordination of care for people with MSCC is implemented. They noted that the range of clinical specialities involved in care for people with this condition makes this even more difficult. The committee therefore agreed to recommend that MSCC services make clear arrangements to promote coordinated care, for example, by ensuring that referral criteria and processes are clarified, and that communication and information sharing protocols are understood. This would lead to a more effective collaboration between specialties and between primary care and specialist settings which can speed up investigation and diagnosis which ultimately also leads to timely management.

On the basis of their own experience, the committee agreed that MSCC services work most effectively when a multidisciplinary approach is in place, given the number of specialities involved in the care of people with spinal metastases or MSCC. The committee therefore agreed to recommend that MSCC services use a multidisciplinary approach and that each specialty should designate an individual point of contact (which could be a designated person or designated phone number). Having such a single point of contact makes coordination between specialties easier so that the designated first contact knows who to contact when advice or referral is needed. The committee agreed that this would help to make decision making and care planning more efficient and holistic. There was discussion whether all specialities would have to come together in in-person meetings to make decisions which could cause logistical problems and that it is also possible that not all specialties are needed for every discussion. The committee noted that there are now commonly processes in place to make virtual or phone attendance in meetings possible. They did not want to be prescriptive about the way the multidisciplinary approach is implemented because working practices are generally evolving so they did not specify this.

The committee also considered a new analysis conducted for this guideline of an audit of all people referred to an MSCC service between January 2018 until 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), the details of which are described in the related evidence report B. The committee discussed the analysis of deprivation data in the Clatterbridge Cancer Centre audit data (see the de novo economic model in evidence report B) which showed that people in the higher quintiles of deprivation benefited less from service improvements than people in less deprived areas. They agreed that there were many possible explanations that could lead to such findings, for example having less time or experiencing challenges in accessing health services. However, they also acknowledged that this was not restricted to MSCC alone but also relevant to other conditions. They also discussed this in relation to the equality impact assessment conducted during scoping of the guideline which listed a number of factors including socioeconomic status that lead to different health outcomes in cancer. The committee noted that a lot of the factors that could relate to deprivation and health outcomes are general public health concerns that cannot be addressed in a single guideline but agreed that it is important for healthcare professionals to be aware of the impact of health inequalities on outcomes on particular groups of people with spinal metastases, DMI of the spine or MSCC in their local area (for example deprivation). The committee decided that local services should collect and analyse information related to their services because this could help to identify groups that may access services less or may experience other service inequalities. Investigating such information is important because inequalities vary by region. They acknowledged that healthcare professionals are not always aware of the specific inequalities in their area and that education is therefore needed. They thought that this information and education would enable services to make reasonable adjustments to be made in line with the Equality Act 2010 to help address and reduce inequalities.

Roles in a coordinated MSCC service

The committee agreed on the basis of their own experience, that MSCC services are most effective when roles and responsibilities are clearly defined. They discussed that the condition is an oncological emergency where timing is crucial to prevent serious long term neurological deficits. Having clear roles and responsibilities will speed up processes and make them more efficient so that the person is triaged more quickly to the services they require. They therefore agreed to set out in the recommendations some of the key tasks that the MSCC coordinator would carry out to provide clarity about the role and standardise it. Based on their knowledge of effective coordinated care the committee agreed that having a clear record of all investigations and assessments is one important responsibility of the coordinator. Having this information in one place and being able to provide it to the relevant speciality when needed is an efficient way to support decision making. The MSCC coordinator should ensure that the initial triage regarding the person’s care is carried out. In this way the person will get the investigations and management they need in a timely manner. Information sharing is also a responsibility of the coordinator so that the specialties have all the details of the investigations and assessment ready to plan treatment. The committee also discussed that safe and timely discharge is important and that this would require a lot of coordination between services. They therefore agreed that the planning in relation to this should also be included in the role of the MSCC coordinator.

The committee discussed that MSCC is a condition with many facets and complexities and therefore referring clinicians would need advice on topics that are covered in other sections of the guideline. This would be initial information that is immediately needed to assess the urgency of actions, such as the options for pain management, the factors that may indicate that there is spinal instability, when to immobilise someone, when or whether corticosteroids should be given, and whether or not transfer to specialist services may be needed. The committee discussed that the initial advice could be given by an MSCC coordinator because the role requires a clinical background.

Based on experience the committee noted that being clear that developing a personalised care plan is part of the role of the senior clinician from the multidisciplinary MSCC team would contribute to better coordinated care. They should work with the person and relevant other healthcare professionals to tailor the care plan to the specific identified needs. They agreed that there were a number of potential specialities that have to be contacted for advice (and they gave examples of these) and having someone with a clear responsibility for making a treatment plan would make liaising between specialties more efficient which would also lead to quicker implementation of the plan. They acknowledged that the previous guideline was prescriptive about the time frame for a personalised care plan within 24 hours. The committee decided that it was important to tailor the planning to the individual and gather all relevant information and advice. They also discussed that the previous guideline focused on MSCC only with regards to a treatment plan within 24 hours and that the current guideline also included people with suspected or confirmed spinal metastases which then required more flexibility around timing. They noted that it could take longer for someone with suspected spinal metastases than someone with MSCC who would need an urgent treatment plan and therefore decided not to specify the timing around this.

The committee also agreed to recommend that due to the emergency nature of conditions such as metastatic spinal cord compression; specialist services treating spinal metastases, direct malignant infiltration of the spine, or MSCC should ensure that a senior clinician is available at all times to provide advice to MSCC services. This would ensure the safety of the person so that prompt action can be taken to prevent serious adverse events.

Providing urgent imaging services

Although there were uncertainties in the evidence on the timing of MRI assessments, the committee agreed that earlier scans for people with suspected MSCC, for example, within 24 hours of admission, led to improved patient outcomes. As this was consistent with their own experience and is well established in practice, the committee agreed to be consistent with the 24 hour timeframe of the previous guideline’s recommendation to ensure prompt diagnosis and maintain standards. Based on the audit data which organised services consistent with the previous guideline and knowledge of other current practices they made service organisation recommendations to enable this, for example in relation to availability of MRI outside normal working hours and planning appointment lists.

Providing support

Based on evidence related to the new analysis of audit data (particularly related to deprivation) and the equality impact assessment conducted during scoping of the guideline (raising issues such as different outcomes by age, sex, ethnicity and other factors) the committee noted that there are many potential inequalities in how people access services and how they experience their care once in a service. They acknowledged that it is often difficult to pinpoint what people may experience as barriers when accessing services and that it can be easy for healthcare professionals to make assumptions according to broad group characteristics. The committee decided that services have to learn from people’s experiences which can only happen by having mechanisms to ask for feedback from people with lived experience and their family or carers. This may highlight particular concerns that people have about any parts of the pathway as well as any other circumstances that create difficulties for them which could be social or practical (for example finding it hard to physically get to the service or having disabilities that may impact how they experience services). They agreed that the MSCC service could adapt to better meet the needs of the people using it, by discussing with people and their family or carers about their experience of the service and any concerns that they may have.

Timing of MRI assessments

The committee noted that the previous guideline’s 24 hour MRI turnaround which they decided to adopt because of the emergency nature of the condition, was also based on the previous guideline’s economic model which was consulted on and published alongside the guideline and was found to be cost effective. The committee discussed, based on experience, that currently too many people with suspected MSCC are transferred to specialist centres for MRI investigations. They agreed that this would not be needed and that MRI should if possible be at the local hospital or appropriate centre with direct access imaging facilities, as this would usually be quicker and avoid lengthy and potentially painful transfers for the patient. They acknowledged that local hospitals may not always have the capacity to perform MRIs at short notice and in this case transfer to a tertiary centre would be needed.

The committee agreed that less urgency was required for those with suspected spinal metastases or DMI of the spine but without suspicion of MSCC, and that a 1-week timeframe was reasonable. This is due to the much lower risk of disability in case of a few days’ treatment delay in this group. Given the less urgent nature they agreed that it should be possible to schedule this MRI at the local hospital.

The committee agreed, based on their experience, that most MRIs could be done in-hours but acknowledged that in some cases an out-of-hours MRI would be appropriate in emergency situations where treatment has to start immediately, for example when there are concerns about a potential spinal column collapse.

How the recommendations might affect services

The committee 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 for MSCC services significantly. 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 that was already set up and providing full spinal oversight showed that once implemented it resulted in cost savings per person and increased overall survival, prevented people losing function and maintained their independence (for key points see the section below and for the full economic model see evidence review B). 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. There have been substantial improvements since the publication of the previous guideline that recommended MSCC services including the role of the MSCC coordinator. One example of how services have developed and improved is that they have their first contact within oncology which makes services quicker and more efficient because knowledge about the primary cancer and the prognosis can be disseminated to other specialists more quickly aiding decision making. Also, the availability of MRI scanning in local hospitals has improved since the previous guideline and so the committee recommended that people are not transferred unnecessarily. The committee noted that there is still variation in the way the roles within the service are implemented and so recommended the roles and responsibilities for key members of the MSCC service should be to provide clarity about their own role as well as to everyone within the team. Having designated contacts for each specialty within the MSCC service is not current practice everywhere but the committee agreed that this would make information sharing and collaboration across teams quicker and more efficient.

Cost effectiveness and resource use

No previous economic evidence was identified in the review of the economic evidence. Therefore, all considerations around cost effectiveness and resource use were drawn from the bespoke economic model developed for this and Evidence Report B and the committee’s own experience and knowledge. The bespoke economic model for the evidence report was a ‘before and after’ study. The ‘before’ service was fully compliant with the previous NICE guideline and the ‘after’ included some upskilling of staff, from a range of disciplines, to become trained MSCC coordinators and strengthen the current working practices. The economic model found that upskilling staff to become MSCC coordinators and be able to make complex decisions around patients referred to a regional MSCC service led to higher survival, greater QALYs and reduced costs. The committee thought these outcomes were plausible even though there were weaknesses with the study due to being unable to adequately control for confounding factors. Extrapolating from this, the committee considered that these cost savings and health improvements came from quicker diagnosis and treatment and that similar interventions to improve these areas would also lead to similar results. The committee also highlighted from the ‘before and after’ study that survival had improved year on year since the creation of the service. This was used as support for a number of recommendations which mirrored the Clatterbridge Cancer Centre MSCC service.

The bespoke economic model for this guideline did not include any costs for setting-up a coordinated service or training more MSCC coordinators. These costs will include the creation of computer systems (to manage people referred to the service, collect audit data and allow for virtual multidisciplinary team meetings), pathways, referral forms and regional guidelines. A new centre will also need communication, engagement and training events with referring organisations to explain and teach the new processes. This will lead to a large one-off cost. There will be opportunities for learning from other centres, like the Clatterbridge Cancer Centre MSCC service, which will provide efficiencies. The bespoke economic model showed that costs decreased per person after the creation of the service and therefore it could be inferred that implementation costs should be regained over the first few years of a newly set up service.

A number of recommendations were made that mirrored the Clatterbridge regional MSCC centre including a designated point of contact for services available 24 hours a day, 7 days a week and coordinated care including common referral criteria and processes clearly communicated to referring centres. Whilst the economic model did not explicitly look at all these interventions it was noted by the committee that the audit data used in the model started at the creation of the regional service (including the aspects above) and that length of survival had increased and cost per person had decreased over time. Pathways need to make sure that people with suspected MSCC are referred promptly to up-trained staff for a treatment or referral decision to realise the benefits of an MSCC coordinator and having more people trained to this level is one way of achieving this. As above there will be some upfront costs from implementing these recommendations such as running events to promote and explain the pathway, but these should be short term and regained from later cost savings.

The committee raised concerns that whilst there would be benefits from these recommendations that they may not be spread equally across all socioeconomic groups based on the health inequalities analysis in the economic model. Recommendations were therefore made that local services should collect, analyse and disseminate information on local health inequalities and that feedback should be sought from service users and their families so that potential concerns about access to services can be addressed. As auditing of services will already be happening for MSCC services this should not require any additional time or resources. Socio-economic data can be added easily to the audit data for example through matching Indices of Multiple Deprivation data to an individual’s postcode.

The committee also recommended that 24-hour MRI should be available locally for urgent cases which potentially require treatment immediately. The committee acknowledged that providing this 24-hours a day leads to higher costs. Out-of-hours services are also difficult to staff. The committee therefore only made this recommendation for these urgent cases where more rapid intervention could lead to large survival and quality of life gains and where costly adverse events (such as paralysis) can be averted.