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National Clinical Guideline Centre (UK). Stroke Rehabilitation: Long Term Rehabilitation After Stroke [Internet]. London: Royal College of Physicians (UK); 2013 May 23. (NICE Clinical Guidelines, No. 162.)
To ensure the safety of the person with stroke while maintaining a patient centred approach, key processes need to be in place. These processes include assessment on admission to the rehabilitation service, individualised goal setting and patient centred care-planning. This chapter reviews those processes.
A search for systematic reviews was carried out for assessment for rehabilitation, goal setting and rehabilitation planning. Direct evidence from systematic reviews was not identified for assessment for rehabilitation (6.1) and recommendations were therefore drawn from the modified Delphi consensus statement. A systematic review for goal setting (6.2) was identified and updated (Rosewilliam 2011 221 ). Not all aspects of goal setting were covered by the included systematic review and therefore additional Delphi statements were drafted from published national and international guidelines and recommendations were made based on both the review and the Delphi consensus statements. Direct evidence from systematic reviews was not identified for rehabilitation planning (section 6.3) and recommendations were therefore drawn from the modified Delphi consensus statement.
| Number | Statement | Results % | Amount (No. panel members who commented/No. panel members who responded) and content of panel comments – or themes |
|---|---|---|---|
| After admission to hospital the person who has had a stroke should have the following assessed as soon as possible: | 34/100 (34%) panel members commented: |
The phrase ‘full assessment ‘was queried by one (“If you mean that a full neurological assessment includes a screening process that can lead to a more detailed assessment as needed then I ‘strongly agree’”)
Some people wanted additional assessments (swallow, coordination, movement control, shoulder subluxation for instance)
It was mentioned that this should be done according to need and that people should not be over assessed.
The need to have a neurologist doing this was questioned. Dysphagia/Swallow tests Carers Strain Index Modified Rankin Berg Balance Scale General Health Questionnaire (GHQ) Geriatric Depression ScaleOthers panel members highlighted that measures depend on the stage of rehabilitation (“NIHSS is a reasonable baseline whereas the Berg is most useful beyond the acute phase. It also depends on what sort of ‘analysis’ you are expecting to be done. Is the data for understanding the severity of stroke or the outcome of rehab?”)
It was questioned whether the statement refers to outcome or baseline measures (“…It depends what you are trying to show? If it’s outcomes and service demands? Maybe rehabilitation complexity scales to show the demands and resources you need. FIM to show functional outcomes perhaps instead of Barthel.”).
Nottingham Extended Activities of Daily Living Scale| Number | Statement | Results % | Amount and content of panel comments – or themes |
|---|---|---|---|
| 1. | The specific list of professional screening tools to be included: | In round 2 - 48/93 (52%) panel members commented; 40/72(56%) in round 3 – the options changed between rounds 2 and 3: |
Concern was raised about possible recommendations being too prescriptive (“These tools should only be suggested tools not prescriptive as the clinician should be able to make the decision as to the most appropriate tool”.
“The tool is not important as long as it is a validated tool. There is no need to direct which tools people should use”.)
After admission to hospital the person who has had a stroke should have the following assessed as soon as possible:
Positioning Moving and handling Swallowing Pressure area risk Continence Communication Nutritional statusComprehensive assessment takes into account:
Previous functional status Impairment of psychological functioning Impairment of physiological body functions and structures Activity limitations due to stroke Participation restrictions in life are stroke Environmental factors (social physical and cultural)Family members and/or carers should be informed of their rights for a carers’ needs assessment.
The impact of the stroke on the person’s family, friends and/or carers should be considered and if appropriate they can be referred for support.
People who have had a stroke should have a full neurological assessment including cognition, vision, hearing, power, sensation and balance.
Delphi panel members agreed with screening for the following:
Routine collection and analysis of a range of measures should include:
National Institute of Health Stroke Scale Barthel Index Hospital Anxiety Depression Scale (HADS)On admission to hospital, to ensure the immediate safety and comfort of the person with stroke, screen them for the following and, if problems are identified, start management as soon as possible:
orientation positioning, moving and handling swallowing transfers (for example, from bed to chair) pressure area risk continencecommunication, including the ability to understand and follow instructions and to convey needs and wishes
nutritional status and hydration (follow the recommendations in Stroke [NICE clinical guideline 68] and Nutrition support in adults [NICE clinical guideline 32]).
Perform a full medical assessment of the person with stroke, including cognition (attention, memory, spatial awareness, apraxia, perception), vision, hearing, tone, strength, sensation and balance.
A comprehensive assessment of a person with stroke should take into account:
their previous functional abilities impairment of psychological functioning (cognitive, emotional and communication) impairment of body functions, including pain activity limitations and participation restrictions environmental factors (social, physical and cultural).Information collected routinely from people with stroke using valid, reliable and responsive tools should include the following on admission and discharge:
National Institutes of Health Stroke Scale Barthel Index.Information collected from people with stroke using valid, reliable and responsive tools should be fed back to the multidisciplinary team regularly.
Take into consideration the impact of the stroke on the person’s family, friends and/or carers and, if appropriate, identify sources of support.
Inform the family members and carers of people with stroke about their right to have a carer’s needs assessment.
The anxiety that neurological assessment implied that a neurologist would have to undertake the assessment was recognised by substituting the word ‘medical’. The GDG felt a medical assessment was an integral part of a comprehensive rehabilitation assessment.
Activity limitations as defined by the ICF include social attitudes, architectural characteristics, legal and social structures, as well as climate, and terrain. The GDG recognised that a range of additional measures to the Barthel, and National Institute of Health Stroke Scale may be used. Such measures should be used to compare cohorts of data, not to monitor individual progress for rehabilitation.
Since none of the specific screening tools reached consensus the GDG were unable to make a recommendation. However, based on comments of the non-consensus statements the GDG recognised that if measures were to be collected they should be standardised measurement tools with psychometrically robust properties, and staff should be trained in their use and findings should be fed back to the team.
The GDG recognised that there is a distinction between measures and screening tools that should not be used as outcomes.
A search was conducted for systematic reviews comparing the clinical effectiveness of any patient goal setting approaches to alternative rehabilitation goal setting approaches to improve psychological wellbeing, function and activity in adults and young people 16 or older who have had a stroke.
One systematic review (Rosewilliam 2011 221 ) matching our protocol was identified. This review included twenty seven studies (eighteen qualitative, eight quantitative and one mixed method study). We included twenty one studies from this review matching our protocol. The systematic review explored the nature, extent and effects of applying patient-centred goal setting in stroke rehabilitation practice.
A further systematic search (using the same search terms as provided in the identified systematic review) was conducted for studies published since June 2010 which was the search cut-off date of the included systematic review. Two studies (Hale 2010 100 ; Worrall 2011 287 ) (Table 23) matching our protocol were identified from this update search and were also included for this review.
Overview of the two additional studies from the top-up search since the systematic review search cut-off date. See Appendix H for extraction
In the included systematic review (Rosewilliam 2011 221 ) the following methodology was adopted:
Both qualitative (Table 24) and quantitative (Table 25) study designs were included in the reviewQuality of included studies were assessed by using quality criteria adapted from published literatures 256 ; 106 ; 184 . Different sets of quality criteria were used for the qualitative and quantitative studies
Study quality assessment was done initially by one researcher and cross-checked by one of the two other authors
Themes from all qualitative studies matching the review questions were pooledFindings were synthesized by aggregating the themes from the qualitative studies and relating them to findings from quantitative studies
Data from the quantitative studies could not be meta-analysed due to lack of randomised trials Effect sizes (for included quantitative studies) were calculated where possibleQualitative studies in the included systematic review (Rosewilliam 2011 ).
Quantitative studies in the included systematic review (Rosewilliam 2011 ).
For this review, we have added quality ratings (our confidence in the studies) to the qualitative and quantitative studies included in the systematic review. The quality ratings were based on quality characteristics (reported in the included systematic review) that were assessed in the review.
Studies from the systematic review were excluded if they addressed mixed neurological populations, if the proportion of patients with stroke is < 50% or if the number of stroke participants is unclear
For the additional qualitative studies identified in our update search:
The study qualities of Hale 2010 100 and Worrall 2011 287 were assessed and rated using the quality criteria adapted from the included systematic review (Table 26)
We merged findings from the themes that Hale 2010 100 identified: enthusiastically cautious, a tool in the box of interventions, time consuming, not easy to set goals. Findings within these themes matching the qualitative themes in the systematic review are presented (in bold) in our summary of findings table (Table 27)
It was not possible to merge findings from Worrall 2011 287 as this study was strictly on aphasic stroke patients describing their goals and how these goals can be coded (by clinicians) according to the International Classification of Functioning, Disability and Health (ICF) (WHO, 2001). We therefore reported this study separately
Additional qualitative studies from the update search since search cut-off date of included systematic review – here with quality characteristics and ratings.
Summary of findings from the qualitative themes and quantitative evidence from systematic review (Rosewilliam 2011) and additional qualitative study (Hale 2010) from update search.
Worrall 2011 287 (HIGH CONFIDENCE IN EVIDENCE from this study): Describing the goals of people with aphasia and to code the goals according to the ICF
Participants expressed their desire to be normal again and to escape their current situation and return home to the security of their old life
Participants with aphasia spoke of the importance of recovering their communicative function (for example, communication for basic needs as well as communication to express their opinions). They described intense feelings of frustration, hopelessness, isolation, and depression at not being able to talk
Many stressed that the aphasia was of higher priority to them than their physical impairmentsParticipants spoke of the need for communication rehabilitation to be connected to real life and about how communication gave them confidence
Participants wanted more information about aphasia, stroke, prognosis, and what to expect at different stages of rehabilitation
Having information allowed people to start taking control and to participate in decisions about their own therapy and their own rehabilitation
Participants wanted speech therapy that met their needs at different stages of recovery, was relevant to their life, more frequent and continued for longer.
Participants wanted positive relationships and interactions with their speech therapists and other health service providers
Some expressed frustration at not being a part of the decision making in their care, seeking information from sources other than health professionals
Many people reported a feeling of being disempowered by their aphasia. They wanted respect, stating that they were competent people, despite their communication difficulties.
Younger people with aphasia were particularly aware of the loss of work and career and often held deep, strong desires to return to some employment
No relevant economic evaluations were identified.
In the absence of cost-effectiveness analysis for this review question, the GDG considered the expected differences in resource use between the comparators and relevant UK NHS unit costs. Consideration of this alongside the clinical review of effectiveness evidence was used to inform their qualitative judgement about cost effectiveness.
Based on the details of the clinical studies, the resources associated with the goal setting intervention are equivalent to an hour of multi-disciplinary team time for the initial goal setting and half an hour for each review. These costs are summarised in Table 28.
Intervention costs goal – setting.
Two studies 171 259 found that patients perceived that making progress towards personally meaningful goals had been good for their self-image, getting back to work, independence, avoiding embarrassment in public and helped as a coping mechanism (MODERATE CONFIDENCE IN STUDIES)
One study 49 found that patients perceived they were not in control of their goals and their involvement with goal setting was passive (MODERATE CONFIDENCE IN STUDY)
Two studies 295 49 found that participation in goal setting could be improved by processes such as formal documentation of the patient’s views, empowering key workers to be proactive, responding flexibly to their changing needs and the use of grading systems to measure their goal achievement (MODERATE CONFIDENCE IN STUDIES)
One study 150 found that patients’ social and occupational needs were not incorporated into the treatment goals, and that patient-centeredness in goal setting would improve patient’s motivation, effective use of time and contribute to holistic planning (MODERATE CONFIDENCE IN STUDY)
Two studies 150 55 highlighted ‘concerns about future risks’, socio-cultural barriers, environmental and resource implications as reasons that could limit adoption of a patient-centred approach in goal setting (MODERATE to HIGH CONFIDENCE IN STUDIES)
One study 100 found that a measurement tool (GAS) was found useful in guiding treatment and assisting therapists to set patient-centred goals but concerns were raised about the reliability of this tool (LOW CONFIDENCE IN STUDY)
One study 150 found that current goal-setting practice is not largely patient-centred (MODERATE CONFIDENCE IN STUDY)
One study 100 found that professionals (physiotherapist) were undecided about the use of Goal Attainment Scaling (GAS) in their practice (LOW CONFIDENCE IN STUDY)
Four studies 150 28 , 101 5 found that discrepancies in perception of illness and recovery between the patient and professional lead to conflicts in the goal-setting process which also impacted on other realms of rehabilitation (VERY LOW to MODERATE CONFIDENCE IN STUDIES)
Five studies 149 150 252 200 175 highlighted factors inhibiting patients from participating in goal settings. These factors include: limited time, presiding professional routines, goal setting meeting which is held away from the patient, single opportunity to meet clinicians post discharge for secondary risk management, stroke pathology with its highly unpredictable recovery prognosis and its effects such as aphasia and (LOW to MODERATE CONFIDENCE IN STUDIES)
Three studies 150 49 200 highlighted psychosocial factors inhibiting patients from participating in goal settings. These factors include: inability to accept the occurrence of stroke, depression, patients guarding against exposing their incompetence (MODERATE CONFIDENCE IN STUDIES)
Two studies 150 175 highlighted that a multidisciplinary team approach involving the patient along with specialists such as speech pathologists improves discussion and documentation of patient goals (MODERATE CONFIDENCE IN STUDY)
Four studies 214 205 46 91 showed that patient-centred goals led to short-term improvement in activities of daily living, better global outcome, better motor outcomes and better self-perceived performance and satisfaction (VERY LOW to LOW CONFIDENCE IN STUDIES)
One study 150 mentioned that patient and family should be educated with regards the pathology, process of rehabilitation, setting goals and patients should be encouraged to identify goals that are in line with their expectation (MODERATE CONFIDENCE IN STUDY)
One study 287 found that people with aphasia post stroke wanted greater autonomy dignity and respect. They also wanted more information about aphasia, stroke to return to their pre-stroke life to communicate their basic needs and their opinions (HIGH CONFIDENCE IN STUDY)
No cost effectiveness evidence was identified.
Ensure that people with stroke have goals for their rehabilitation that:
are meaningful and relevant to them focus on activity and participation are challenging but achievable include both short-term and long-term elements.Ensure that goal-setting meetings during stroke rehabilitation:
are timetabled into the working week involve the person with stroke and, where appropriate, their family or carer in the discussion.| Number | Statement | Results % | Amount (No. panel members who commented / No. panel members who responded) and content of panel comments – or themes |
|---|---|---|---|
| Both profession specific as well as multidisciplinary stroke teams’ goals should be person focused. | 81.8 | 17/99 (17%) panel members commented |
This was seen important in the process of goal planning by some panel members (“Absolutely. We don’t do this enough yet and we need to get much better at this to use outcome measures properly and really effectively.”)
It was seen as most important that goals should be set by or set collaboratively with the person who has had a stroke (“Goals need to be genuinely person generated.”
“Goal setting should be collaborative, set with the patient, and multidisciplinary rather than uni-disciplinary”
“There should be one set of patient agreed patient centred goals”)
It was highlighted that these expectations need to be realistic.
Some people questioned the term ‘efforts’ and what this would mean in real terms.
Rather than themes individual issues were highlighted:
The type of goal depends on the stage and setting of rehabilitation (“Initial goals in the acute setting may be less focussed on activities and participation as the treatment begins to develop a base from which further goals may be set, for example increasing the length of treatment that can be tolerated. Not all objectives can be identified within recognised assessment tools in the early stages.”)
Some goals might not be easily measurable (“Goals do not have to be measurable as improvement in engagement and motivation can be a goal that will be difficult to quantify.”)
Goals should be jargon free.
| Number | Statement | Results % | Amount and content of panel comments – or themes |
|---|---|---|---|
| Goals should have predicted dates for completion. | 36.5 | In round 2 – 24/98 (24%) panel members commented; 19/85(22%) in round 3: |
Themes:
Flexibility – timing of goals should not be too rigid and prescriptive.
Generally this was seen as positive, but it was stated that this may be too reflective for some and that it needs to benefit the individual rather than be a measure of outcome.
There was a feeling that the format of this documentation would not always be accessible to the person who has had a stroke (cognitive or language impaired persons for instance).
“It might be helpful if this stated that these goals should be in language appropriate to the patient (not MDT language) and that where possible, they should reflect the patient’s own words in setting the goals.”
Both profession specific as well as multidisciplinary stroke teams’ goals should be person focused.
Efforts should be made to establish the wishes and expectations of the person who has had a stroke and their carer/family.
The following criteria should be used when setting goals with the person who has had a stroke:
Meaningful and relevant Should be focused on activities and participation Challenging but achievable Both short and long-term targets May involve one MDT team member or may be multidisciplinary Involve carer / family where possible, with consent of person who has had a stroke Used to guide therapy and treatmentEnsure that during goal-setting meetings, people with stroke are provided with:
an explanation of the goal-setting process the information they need in a format that is accessible to them the support they need to make decisions and take an active part in setting goals.Give people copies of their agreed goals for stroke rehabilitation after each goal-setting meeting.
Review people’s goals at regular intervals during their stroke rehabilitation.
| Number | Statement | Results % | Amount (No. panel members who commented / No. panel members who responded) and content of panel comments – or themes |
|---|---|---|---|
| Documentation related to rehabilitation should be individualised, and contain the following minimum information: | 17/99 (17%) panel members commented: |
A number of additional documents were suggested:
Return to work information was mentioned most frequently
Information on additional support available after discharge (for example, carer support organisations and stroke support groups)
This was seen as important in person centred care.
It was mentioned that the wishes of the person who has had a stroke should be taken into consideration. Some people find this a stressful experience.
The phase of rehabilitation was commented on. Weekly reviews early on in the acute phase, or when the person who has had a stroke is an inpatient, reducing to longer intervals as the rehabilitation progresses.
“not sensible. In first 6 weeks weekly is needed there after two weekly is reasonable – or longer”
“in light of the quick throughput of hospital stroke patients the review may need to be undertaken twice a week”.
There was a concern not to be too prescriptive about timing.
“because each person who has had a stroke is different, the review should take place according to needs of the individual and this will vary”
Type of plan and type of goal was also seen as important:
| Number | Statement | Results % | Amount and content of panel comments – or themes |
|---|---|---|---|
| 1. | When there is a significant change, or when a plateau/potential is reached, or before discharge, a meeting involving the stroke rehabilitation team, with an invitation to the person and their family/carer, should be conducted to discuss these points. | 63.4 | In round 2 – 22/99 (22%) panel members commented; 16/85(19%) in round 3 and 11/72 (15%) in round 4: |
There were several themes:
MDT – some members of the panel thought that this does not have to involve the whole team (“The meetings should happen but only include the relevant staff, not the whole stroke rehabilitation team”).
Before discharge – this was seen as the most important aspect of the statement.
Need for an additional meeting – if there are regular reviews then changes / plateau should not come as a surprise
Meeting type – this needs to be tailored (formal or informal) to the individual and their carer/family
Statement – the statement itself was seen as having too many different components to answer with one response.
Documentation related to rehabilitation should be individualised, and contain the following minimum information:
Basic demographics including contact details and next to kin Diagnosis and relevant medical information List of current medications including allergies Standardised screening assessments to include those identified in earlier questions Person focused rehabilitation goals Multidisciplinary progress notes Key contact from the stroke rehabilitation team to co-ordinate health and social care needs Discharge planning information Joint health/social care plans if developed Follow-up appointmentsIn the development of rehabilitation plans, efforts should be made to encourage the person who has had a stroke and carers to be involved and actively participate.
Rehabilitation plans should be reviewed by the multidisciplinary team at least once per week.
Provide information and support to enable the person with stroke and their family or carer (as appropriate) to actively participate in the development of their stroke rehabilitation plan.
Stroke rehabilitation plans should be reviewed regularly by the multidisciplinary team. Time these reviews according to the stage of rehabilitation and the person’s needs.
Documentation about the person’s stroke rehabilitation should be individualised, and should include the following information as a minimum:
basic demographics, including contact details and next of kin diagnosis and relevant medical information list of current medications, including allergies standardised screening assessments (see recommendation 18) the person’s rehabilitation goals multidisciplinary progress notesa key contact from the stroke rehabilitation team (including their contact details) to coordinate the person’s health and social care needs
discharge planning information (including accommodation needs, aids and adaptations) joint health and social care plans, if developed follow-up appointments.It was thought that care planning is an element of goal setting. Although some comments had been made that the statements were rather obvious, the GDG thought that providing support to enable the person and carers to be involved in the development of their rehabilitation plans through having knowledge and feeling empowered to participate was a key recommendation to make.
The dose of rehabilitation that individuals receive varies from country to country and service to service. In specialist neurorehabilitation services patients may receive 5 hours of therapy each day, in others 1 or 2 hours each day. Duration of therapy may vary from 2 weeks to 3 or 6 months with some patients accessing or re-accessing input some years after the onset of stroke.
The National Stroke Strategy 61 states ‘People who have had strokes access high-quality rehabilitation and, with their carer, receive support from stroke-skilled services as soon as possible after they have a stroke, available in hospital, immediately after transfer from hospital and for as long as they need it’. The NICE stroke quality standard 189 specifies that ‘Patients with stroke are offered a minimum of 45 minutes of each active therapy that is required, for a minimum of 5 days a week, at a level that enables the patient to meet their rehabilitation goals for as long as they are continuing to benefit from the therapy and are able to tolerate it.’ Many frail older patients with co-morbidities cannot tolerate such intensity in the early stages after stroke, other patients can tolerate far more. In other spheres where motor learning is important it is accepted that the degree of performance improvement is dependent on the amount of practice. In stroke where there is a range of impairments and as patients move around in changing environments there is uncertainty about the benefits of increasing the total dose of therapy whether in terms of intensity (hours per day) or duration of therapy (weeks).
Searches were conducted for systematic reviews and RCTs comparing the effectiveness of intense rehabilitation with usual care for rehabilitation after stroke for adults and young people 16 or older that have had a stroke. Only studies with a minimum sample size of 20 participants (10 in each arm) and including at least 50% of participants with stroke were selected. Four (4) RCTs were identified. Table 33 summarises the population, intervention, comparison and outcomes for each of the studies.
Summary of studies included in the clinical evidence review. For full details of the extraction please see Appendix H.
Intensive rehabilitation versus standard rehabilitation - Clinical study characteristics and clinical summary of findings.
Intensive rehabilitation versus no rehabilitation - Clinical study characteristics and clinical summary of findings.
No relevant economic evaluations comparing different intensities of multidisciplinary rehabilitation were identified.
Full methods and results are presented in Appendix K; a summary is provided below.
The GDG identified the comparison of more intensive programmes of rehabilitation for people with stroke with less intensive programmes as a high priority area for economic analysis.
More intensive rehabilitation may be more costly to deliver than less intensive rehabilitation because it may require additional staff time. However, additional costs may be offset by an improvement in outcomes for the patient (such as independency in activities of daily living), leading to increased QALYs and potentially a reduction in future healthcare and social care costs.
The following general principles were adhered to in developing the cost-effectiveness analysis:
The GDG was consulted during the construction and interpretation of the model.Model inputs were based on the systematic review of the clinical literature supplemented with other published data sources where possible.
When published data was not available expert opinion was used to populate the model. Model inputs and assumptions were reported fully and transparently. The results were subject to sensitivity analysis and limitations were discussed. The model was peer-reviewed by another health economist at the NCGC.A cost-utility analysis was undertaken to evaluate the cost-effectiveness of more intensive versus less intensive stroke rehabilitation. Lifetime quality-adjusted life years (QALYs) and costs were estimated from a current UK NHS and personal social services perspective. As is standard practice in economic evaluation, both costs and QALYS were discounted to reflect time preference; a rate of 3.5% per annum was used in line with NICE methodological guidance 187 . The cost effectiveness outcome of the model was cost per QALY gained.
The analysis was primarily based on data from the UK clinical study reported by Ryan and colleagues, 2006 225 described in the clinical review above.
A probabilistic analysis was undertaken to evaluate uncertainty in the model input estimates. In addition, various sensitivity analyses were undertaken to test the robustness of model assumptions and data sources. In these, one or more inputs were changed and the analysis rerun to evaluate the impact on results.
The GDG noted that the intensity level in the more intensive rehabilitation arm in the study reported by Ryan and colleagues was likely to be lower than that now specified by the stroke quality standard 188 . We therefore undertook exploratory threshold analyses to provide information to help inform the GDG decision making.
The population for the cost-effectiveness analysis comprised adults and young people aged 16 or older who have had a stroke and required rehabilitation.
The comparators in the model were:
Less intensive multidisciplinary rehabilitation More intensive multidisciplinary rehabilitationFollowing Ryan et al. (2006) 225 , the intervention was assumed to be delivered at home. Less intensive rehabilitation was three or less face-to-face contacts per week, for 12 weeks maximum. More intensive rehabilitation in the study was six or more face-to-face contacts per week, for 12 weeks maximum.
A life table approach was taken to the analysis. Life tables for England and Wales were adjusted for the increased mortality in people who have had a stroke. This estimated the number of people alive after each 3 month period (each cycle) and this was used to estimate life years for people in the model. It was assumed that mortality is not impacted by the type of rehabilitation received and so life expectancy did not vary by comparator in the model.
A quality of life (utility) value was attributed to people who were alive in the model that depended on the type of rehabilitation received (‘more intensive’ or ‘less intensive’). This resulted in differences in QALYs between patients.
Differences in total costs between the more and less intensive rehabilitation groups were due to differences in the cost of delivering rehabilitation – this cost was incurred in the first 3 month cycle. It was assumed in the base-case analysis that in the post-rehabilitation period costs did not vary between the more intensive and the less intensive rehabilitation.
Model inputs were based on clinical evidence identified in the systematic review undertaken for the guideline, supplemented by additional data sources as required. Model inputs were validated with clinical members of the GDG. A summary of the model inputs used in the base-case (primary) analysis is provided in Table 36 below. More details about sources, calculations and rationale can be found in the full technical report in Appendix K.
Summary of base-case model inputs.
The analysis found that more intensive rehabilitation was cost effective compared to less intensive rehabilitation, based on levels of intervention and outcomes from the Ryan et al. 2006 study 225 . There was an additional cost associated with more intensive rehabilitation as more rehabilitation sessions were provided; however this was offset by the additional improvement in quality of life that results in higher QALYs. This conclusion was seen with all long-term utility scenarios. There was low within analysis uncertainty about this conclusion. It was also robust to a range of sensitivity analyses around input parameters
| Analysis | Mean cost difference (more - less) (a) | Mean QALY difference (more - less | Incremental cost effectiveness ratio (ICER) | % simulations ‘more intensive’ cost- effective (£20K/QALY) |
|---|---|---|---|---|
| Scenario 1 - difference in utility maintained over time | ||||
| Maintained over lifetime | £226 | 0.70 | £324 | 99% |
| Scenario 2 - utility difference disappears over time | ||||
| Disappears over 3 months | £228 | 0.03 | £6,722 | 95% |
| Disappears over 1 year | £228 | 0.08 | £2,751 | 99% |
| Disappears over 5 years | £226 | 0.29 | £776 | 100% |
Minor difference are due to results being from different runs of the probabilistic analysis
Full results tables are shown in the full technical report in Appendix K.
An analysis was undertaken to determine the cost difference threshold where intensive rehabilitation was no longer cost-effective (using a £20,000 per QALY gained cost-effectiveness threshold). Under the most conservative long-term utility assumption (where the utility difference observed at the end of rehabilitation had disappeared over 3 months), more intensive rehabilitation would no longer be cost effective if the difference in rehabilitation cost was more than £685 (equivalent to a difference of about 17 sessions, of 45 minutes, with a rehabilitation professional). Under the most favourable utility assumption (where the difference observed at the end of rehabilitation was maintained indefinitely), more intensive rehabilitation remained cost effective until the difference in rehabilitation costs exceeded £13,433 (equivalent to a difference of over 300 sessions with a rehabilitation professional).
We also undertook a threshold analysis where we varied the difference in the number of rehabilitation sessions between the groups and then calculated what QALY difference would be required for it to be considered cost-effective. The GDG estimated that in current UK practice a level of input in line with the current NICE quality standard would be 45 minutes of each relevant therapy at least 5 days a week as long as they are continuing to benefit from it. Thus over 6 weeks an individual might receive 60 – 90 sessions of input. The GDG recognised that the recent Stroke Sentinel audit highlighted that about a third of patients received less than this while in hospital 123 . No data is available for community based rehabilitation services. The GDG estimated that a typical level of input would be three physiotherapy sessions per week, one occupational therapy session per week, and one speech and language therapy session per week (that is 30 sessions). This would be a difference of 60 sessions total between ideal and typical input. The difference in number of sessions was therefore varied between 6.5 (from the Ryan et al. 2006 study) and 60 (based on the GDG estimate).
The lifetime QALY gain required for more intensive rehabilitation to be cost effective ranged from 0.01–0.11 when the difference in number of rehabilitation sessions was varied between 6.5 and 60.
We then also calculated the number of months for which, different quality of life (utility) gains would need to be maintained, in order to achieve these QALY gains. With a difference of 60 rehabilitation sessions with more intensive compared to less intensive rehabilitation, it was found that a utility gain of 0.14 (as observed in the Ryan et al. 2006 study) would need to be maintained for 9 months in order for more intensive rehabilitation to be cost effective. When utility gain was varied between 0.02 and 0.24, this varied from 5 months to 64 months.
The key limitations of this analysis are the limitations of the clinical effectiveness data for the comparison of more and less intensive rehabilitation. Only one study reported utility data that could be used to calculate QALYs and the amount of rehabilitation received in this study compared with the current quality standard, and even current UK practice is very different. In study reported by Ryan and colleagues more intensive rehabilitation was a total of 17 sessions on average per person and less intensive was 11. The GDG estimated that a level of intervention similar to that recommended by the current NICE quality standard would be more like 90 rehabilitation sessions per patient (spread across specialities), and that typical levels of input in the UK would be around 30 sessions.
It was noted that rehabilitation is a complex intervention, that is, the outcome does not vary linearly with inputs. One possibility is that there is a critical threshold for improvement. For example, if one leg is weak the patient will be unable to walk. The strength may increase linearly for 6 weeks, but only in week 7 will the patient walk. If a functional outcome is used, the patient will appear to plateau for 6 weeks and then may show a significant change in functional status. This again makes it difficult to extrapolate from the study reported by Ryan and colleagues.
It was noted that younger patients also often have the capacity to participate in more sessions of rehabilitation as this is linked to cardiovascular fitness, frailty and co-morbidity, all of which tend to be worse in older patients. They also often have a greater range of needs (education, work, and parenting). Yet often younger patients do not get more rehabilitation. It was not possible to undertake subgroup analysis on this basis in the model as not clinical studies had examined this.
The study reported by Ryan and colleagues reported EQ5D quality of life data at 3 months but did not have any longer term follow-up and so assumptions were made regarding what happens to the difference in quality of life over time between the groups. However both conservative and more favourable assumptions were explored in the model to test the impact on results.
The analysis does not include any impact on carer quality of life as there was no evidence available. It is plausible that greater functional ability for the person who has had a stroke may also mean less burden on their carer and this may lead to an improvement in the carer’s quality of life as well. If this were the case, this would increase the QALY gain with more intensive rehabilitation, making it more cost effective.
In the base-case analysis we assumed no difference in post-rehabilitation costs; however greater functional ability could plausibly result in lower dependency and potentially lower social care costs. This would further favour more intensive rehabilitation.
The study reported by Ryan and colleagues was based on community rehabilitation and so costs in the model are also based on community rehabilitation. The GDG considered that the amount of rehabilitation should be the same whether delivered in the community or in hospital. In addition if rehabilitation was taking place in hospital the intensity of rehabilitation would most likely not change the length of stay but would just impact the amount of input from different professionals whilst in hospital. Therefore in either setting the cost impact would largely be about people’s time rather than changes in hospital capacity, overheads or hotel costs and so this was not considered likely to greatly impact the results. It was noted that potentially more intensive rehabilitation during the initial hospitalisation may even reduce hospital stay as patients become more functionally able more quickly.
One study 225 with 89 participants found no significant difference between the intensive rehabilitation group and the standard rehabilitation group at 3 months on the Barthel Index (MODERATE CONFIDENCE IN EFFECT).
One study 225 with 89 participants found a statistically significant improvement in the intensive rehabilitation group compared with the standard rehabilitation group at 3 months, on the Euroqol Visual Analogue Scale (MODERATE CONFIDENCE IN EFFECT)
One study 225 with 89 participants found a statistically significant improvement in the intensive rehabilitation group compared with the standard rehabilitation group at 3 months, on the Euroqol-5D (MODERATE CONFIDENCE IN EFFECT)
One study 225 with 89 participants found no significant difference on the Frenchay Activities Index between the intensive rehabilitation group and the standard rehabilitation group at 3 months follow-up (LOW CONFIDENCE IN EFFECT)
One study 196 with 60 participants found that there was a statistically significant improvement in the Functional Independence Measure in the intensive rehabilitation group over a 60-day follow-up, compared with the less intensive home-based group (LOW CONFIDENCE IN EFFECT).
Evidence statements could not be produced for the following outcome(s) as results were not presented in a way that enabled the size of the intervention’s effect to be estimated:
Activities of Daily Living Index 241 Functional Independence Measure (Motor) 282More intensive rehabilitation was found to be cost effective compared to less intensive rehabilitation, based on a modelled analysis using levels of intervention and outcomes from the Ryan et al. 2006 study (24 versus 18 rehabilitation sessions; EQ5D difference 0.14 at 3 months) and a range of long-term utility assumptions. However, these conclusions are limited by concerns regarding applicability of the study reported by Ryan and colleagues to current UK practice. Exploratory threshold analyses found:
Under the most conservative long-term utility assumption (where the utility difference observed at the end of rehabilitation had disappeared over 3 months), more intensive rehabilitation would no longer be cost effective if the difference in rehabilitation cost was more than £685 (equivalent to a difference of about 17 sessions, of 45 minutes, with a rehabilitation professional).
Under the most favourable long-term utility assumption (where the difference observed at the end of rehabilitation was maintained indefinitely), more intensive rehabilitation remained cost effective until the difference in rehabilitation costs exceeded £13,433 (equivalent to a difference of over 300 sessions with a rehabilitation professional).
Assuming a difference of 60 sessions between more and less intensive rehabilitation: a utility difference of 0.14 would need to be maintained for 9 months for more intensive to be cost effective; a difference of 0.24 for 5 months; and a difference of 0.02 for 64 months (about 4 years).
Offer initially at least 45 minutes of each relevant stroke rehabilitation therapy for a minimum of 5 days per week to people who have the ability to participate, and where functional goals can be achieved. If more rehabilitation is needed at a later stage, tailor the intensity to the person’s needs at that time g .
Consider more than 45 minutes of each relevant stroke rehabilitation therapy 5 days per week for people who have the ability to participate and continue to make functional gains, and where functional goals can be achieved.
If people with stroke are unable to participate in 45 minutes of each rehabilitation therapy, ensure that therapy is still offered 5 days per week for a shorter time at an intensity that allows them to actively participate.
Intensity of therapy for dysphagia, provided as part of speech and language therapy, is addressed in recommendation 1.7.2
