Rehabilitation after stroke: summary of NICE guidance

Dear Sirs,

The new NICE guidelines on stroke rehabilitation1,2 recognise that high quality stroke care services should include physical rehabilitation, as well as stroke-specialised psychological and emotional support to stroke survivors. We do, however, wish to stress the serious financial implications that can bring considerable anxiety and stress to the stroke survivor and their families during rehabilitation.

In Wales, we have formed a multi-professional student group3, as a collaboration between Institute for Healthcare Improvement Open School chapters4, specifically to work with higher education, healthcare and volunteer organisations, including the Stroke Association and patients themselves. We meet monthly to learn about the role of each healthcare professional in the stroke care pathway through peer-led teaching, as well as run group activities such as identifying the ‘Top 5 basic care needs’ that all students can assist stroke patients with regardless of professional role whilst on placement. Stroke patients share their stories at our meetings, and their experiences consistently highlight the harsh realities of ‘life after discharge’. Recurring themes include frustration with the lack of available psychological support, and very often the anxiety resulting from the financial burdens associated with long-term care needs during rehabilitation. All patient stories we have heard rate highly the support provided up to 6 weeks post discharge, but NHS and local authority funded care after this point can diminish rapidly, leaving many patients without access to full reablement services, or being forced into funding it themselves5.

One stroke survivor shared that he had saved his whole life for early retirement. Following his stroke, he was unable to return to work and his wife gave up her job to assist him with activities of daily living. The family has since endured nearly a decade of financial hardship living off their savings. Now that they are depleted of their savings, they are only now entitled to help in adapting their home. There is a huge discrepancy between the level of care available in the acute phase and in the following rehabilitation phase. This shortcoming forces many stroke survivors to spend their life savings before they can access even basic care services funded by the NHS and social services.

Yours faithfully,

Miss Hope Olivia Ward, 3rd year medical student, Cardiff University
Miss Beth McIldowie, 3rd year medical student, Cardiff University
Miss Sarah Kibble, 3rd year medical student, Cardiff University
Dr Amanda Squire, Inter-professional education lead, Cardiff Metropolitan University
Dr Andrew Carson-Stevens, Clinical Lecturer in Healthcare Improvement, Cardiff University School of Medicine (corresponding author: andypcs@gmail.com)

1. National Institute for Health and Care Excellence (2013) [Stroke Rehabilitation]. [CG162]. London: National Institute for Health and Care Excellence.
2. Dworzynski K, Ritchie G, Fenu E, MacDermott K and Playford ED. Rehabilitation after stroke: summary of NICE guidance. BMJ2013;346:f3615
3. Squire A, Carson-Stevens A, Jones A, Hearle A and Evans E. 2013. Joined up care – interprofessional approaches to improving patient care. [Poster] 17th May 2013 Learning and working together to improve safety through better prescribing, Cardiff Hilton Hotel.
4. Institute for Healthcare Improvement Open School, 2013.Overview. Available at: http://www.ihi.org/offerings/IHIOpenSchool/overview/Pages/default.aspx [accessed 9 July 2013].
5. The Stroke Association. Struggling to recover. May 2012. London: The Stroke Association

Whilst fully endorsing the concerns expressed by others [1,2] about the methodological shortcomings of the NICE guideline development itself, I wish to respond to the NICE research priorities [3]. One of these is ‘Which cognitive and emotional interventions provide better outcomes for identified subgroups of people with stroke and their families and carers at different stages of the stroke pathway?’

I strongly support the importance of this question, albeit many different questions all rolled into one that will need careful teasing apart. As co-author of several Cochrane reviews of post-stroke cognitive rehabilitation I am all too aware of the absence of robust research evidence for effective interventions for cognition and emotion. Recently the James Lind Alliance identified ‘ways to improve cognition after stroke’ as the number 1 shared research priority for survivors, carers and health professionals [4]. Another two of the top 10 priorities were around ‘helping people come to terms with long term consequences’ and ‘ways to improve confidence’. Additionally, when stroke survivors were asked about their longer term unmet needs for health problems in a Stroke Association survey [5], cognitive problems such as memory and concentration were reported as the highest unmet needs (Table 3, 59%, 43% respectively, weighted).

The recent NIHR HTA’s commissioning brief on research into depression post-stroke is an encouraging first step to improve one aspect of psychological well-being after stroke. However, there is insufficient research coming through on the UKCRN portfolio especially with regard to cognitive rehabilitation. One positive outcome from the NICE guideline would be if it influenced serious research investment aimed at improving psychological well-being for survivors and carers. What steps can and will NICE take to achieve this?

1. http://www.bmj.com/content/346/bmj.f3615/rr/652847

2. http://www.bmj.com/content/346/bmj.f3615/rr/652772

3.
http://www.bmj.com/content/346/bmj.f3615

4. http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(12)70029-7/fulltext

5. http://stroke.ahajournals.org/content/42/5/1398

Dear Sir,

We are grateful to Dworzynski et al (1 July, 2013), for their very detailed response to our letter (20 June, 2013). Whilst it is not our intention to prolong the debate, we feel that we need to address some of the points raised. Thus;

1. It is our contention that the ‘standard NICE methodology’ was not appropriate in this guideline and therefore referring us to further information is not helpful.

2. We believe that GRADE was used inappropriately.

3. The response regarding excluding Cochrane systematic reviews does not make sense; how much of a ‘match’ was needed?

4. Dworzynski et al said ‘This is usual practice for NICE guidance unless there is a good reason to consider evidence from another population’. We believe there was good reason as it is not justifiable to address rehabilitation on disease specific criteria.

5. The Delphi survey has been justified as ‘a direct response to Stakeholders’ comments on the initial consultation draft that the guidance did not present a complete stroke rehabilitation pathway…’. However this was because of the scope of the guidelines and the exclusion of high quality evidence. It would have been preferable to re visit these aspects than embark on this Delphi survey.

6. It is not the size but the representativeness of the expert sample which is in question. Other groups may have identified and suggested experts but the sampling frame was under the control of NICE. We cannot see how one could conclude, given the small numbers of particular groups of individuals involved, that there was ‘no evidence that the responses were systematically different to each other.’

7. There may be no ‘hard and fast rules’ about reaching consensus but there is relevant literature (for example, 1, 2); the methodology used in this guideline was flawed and the questions posed were simply wrong.

8. We do not accept that the recommendations ‘reflect the evidence available’. Moreover we do not think that the criticism from stakeholders regarding ‘taking a more holistic approach’ related to the formulation of the recommendations.

9. We are interested in the comment that skilled clinicians could use their judgment. This seems to fly in the face of the usual stand by NICE on rigour and evidence.

10. We re-iterate that these research topics are not likely to be the most pressing in stroke rehabilitation.

11. We do not accept that this document ‘provides guidance to improve clinical care and inform patients and their carers and reduce variations in practice’

Yours faithfully,

Professor Avril Drummond, Professor of Healthcare Research, University of Nottingham. Avril.Drummond@nottingham.ac.uk
Professor Marion Walker, Professor of Stroke Rehabilitation, University of Nottingham.
Professor Derick Wade, Consultant in Rehabilitation Medicine, The Oxford Centre for Enablement.
Professor Pippa Tyrrell, Professor of Stroke Medicine, University of Manchester.
Professor Nadina Lincoln, Professor of Clinical Psychology, University of Nottingham.
Professor Peter Langhorne, Professor of Stroke Care, University of Glasgow.
Professor Peter Sandercock, Professor of Medical Neurology, University of Edinburgh.

1. Murphy E, Black N, Lamping D, McKee C, Sanderson C, et al. Consensus development methods, and their use in clinical guideline development: a review. Health Technol Assess 1998;2(3).
2. Hsu C , Sandford B. The Delphi Technique: making Sense of Consensus. Practical Assessment, Research and Evaluation. 2007; 12: 10

Drummond and colleagues (20 June 2013) have raised several points on the methods used in NICE clinical guideline development and the assessment of the stroke rehabilitation literature in particular. The standard NICE methodology has been followed in the development of this guideline, with the addition of a formal consensus exercise, and we will attempt to answer their specific concerns, but also highlight the availability of ‘The guidelines manual’ that describes NICE methodology in detail and is freely available via the NICE website.

In response to the specific points made, NICE methodology uses the GRADE (Grading Recommendations Assessment, Development and Evaluation) system for rating quality of evidence reviewed. GRADE rates the quality of the evidence for a particular outcome across all the studies rather than rate the quality of individual studies. The studies included in the guideline have therefore not been labelled as being of low quality, but rather, the quality of the evidence for a specified outcome. This quality assessment represents the Guideline Development Group’s summary of their confidence in the estimate of effect from the body of evidence. The reasons for ‘downgrading’ the evidence are presented within the guideline and vary between outcomes, so it is difficult to provide a single explanation for the quality of the evidence across the guideline.

The selection of studies is guided by the question protocol developed in collaboration with the Guideline Development Group. Studies that match the population, intervention and comparator and outcomes stated in the protocol are selected and included in the systematic review. If a Cochrane review matching the protocol was identified it would be included, such as the Cochrane reviews that were included in the speech and language therapy, the physical fitness and the stroke rehabilitation unit reviews. Other Cochrane reviews were used as a source of references. As studies on a stroke population were available for all the questions addressed by the guideline, the GDG believed it was more helpful to consider these than to include indirect evidence on another population. This is usual practice for NICE guidance unless there is a good reason to consider evidence from another population. One consequence of using more indirect evidence would be to downgrade the quality of the evidence further.

The decision to conduct the modified Delphi survey was made as a direct response to Stakeholders’ comments on the initial consultation draft that the guidance did not present a complete stroke rehabilitation pathway, and further work was needed that addressed the structure and process of stroke rehabilitation. Areas highlighted by stakeholders included multi-disciplinary team working, assessment and care planning, and long term health and social support. From further searches conducted and an evaluation of other national and international stroke rehabilitation guidelines it was apparent that there was an absence of robust evidence about the effectiveness of many of the possible interventions in these areas, and this was highlighted by the number of consensus based recommendations made for these areas within other available guidance. The Delphi survey approach was chosen to try to address the difficulties of ‘opinion’ led guidance, by offering the opportunity to create a more robust base to clinical interpretation and subsequent recommendations. This survey has delivered the largest ‘expert consensus’ view within this field, with good multidisciplinary stroke professional body representation that was reviewed by both the GDG and the RCP Stroke Intercollegiate Working Party to ensure relevant experts were identified. Efforts were made to recruit Delphi panel members from all professions and, in the case of an identified under-representation, organisations were contacted to encourage participation. In the analysis of responses received we were able to filter according to profession, and found no evidence that the responses were systematically different to each other.

Drummond and colleagues have questioned the rigour of the methods employed, however an assessment of the literature around Delphi methodology demonstrates no hard and fast rules in relation to reaching consensus. A protocol was developed in consultation with the Guideline Development Group and NICE detailing the proposed methodology and parameters for agreement. In this case a pragmatic approach was adopted to maximise the opportunity to gain consensus but terminating the survey at the point when it was apparent there would be no added value in continuing due to the diverse multi-disciplinary views and opinion. The survey did not present questions, but rather statements and these were based on the recommendations made in other guidance where available. These statements were refined following comments made by the survey participants in the initial round of the survey, and the example quoted was not subsequently included. Furthermore, Delphi panel members had the opportunity to add free text comments to each statement in each round and a qualitative analysis was conducted to identify themes which featured in the discussion and the drawing up of recommendations.

With regards the wording of the recommendations, this reflects the evidence available and the GDG’s interpretation of this evidence balanced with their clinical knowledge and expertise. Much of the evidence demonstrated that people improved in function and mobility from having an intervention, but there was little evidence to support one type of intervention over another. Therefore the GDG were of the opinion that the patient should have a choice, and it would be appropriate for the health professional to discuss with the patient the therapies that may best enable them to achieve their goals, and a range of therapy options given to aid people in making decisions. Whilst Drummond and colleagues may consider more directive recommendations appropriate, stating which patients should have a specific intervention, this was not reflected by other comments received from Stakeholders who criticised the guideline for not taking a more holistic approach reflecting individual patient’s needs. The authors cite the example of the memory and cognitive function recommendations; however we believe they are aware the clinical picture in stroke is complex, and specific targeting of population and intervention could result in a recommendation that is useless. If the whole of this section is read we state assess and then consider a range of strategies tailored to the patient, thus allowing skilled clinicians to use their judgement.

In relation to formulating research recommendations, these are decided by the consensus of the Guideline Development Group, and are for those areas reviewed by the guideline where the GDG agreed there was a lack of robust evidence, and where further research would benefit stroke rehabilitation practice. The guideline has responded to stakeholders and extended the scope of the stroke rehabilitation pathway. It provides guidance to improve clinical care and inform patients and their carers and reduce variations in practice. The guidance will be updated when new evidence emerges to strengthen the evidence base for these, or other, interventions to improve the outcome from stroke rehabilitation.