Systematic reviews

• Only Cochrane systematic reviews were included (however, 1 non-Cochrane systematic review, felt to be topical and important because it was identified by the NIHR signals programme, was also included).

Randomised controlled trials (RCTs)

• Inclusion criteria: Over 50 participants; outcomes matching those in relevant review protocols (where possible) in the guideline.
• Exclusion criteria: Already taken into account in a Cochrane review; non-stroke populations (for example, head injury); pilot, feasibility, exploratory, preliminary, proof-of-concept studies; complementary and alternative medicine.

Adding orthoptics, pharmacy and dietetics to the core multidisciplinary stroke team

No evidence in this area fulfilling the criteria of the current surveillance review was found, and the guideline already includes these aspects of care in a recommendation about ‘access to other services that may be needed’.

Involvement of third sector organisations (such as the Stroke Association)

No evidence in this area fulfilling the criteria of the current surveillance review was found, and the guideline already recommends facilitating participation in community activities, such as civic engagement, stroke support groups and volunteering. Additionally, rehabilitation in partnership with voluntary organisations, including the Stroke Association, is advocated within the NHS Long Term Plan (January 2019).

Hyperacute stroke rehabilitation

Mixed results from 2 heterogeneous RCTs on very early rehabilitation are unlikely to affect the guideline, which does not currently specify a timepoint after stroke within which to start rehabilitation. Additionally, recommendations on early mobilisation are made in the NICE guideline on stroke and transient ischaemic attack in over 16s.

A more individualised ‘rehabilitation prescription’

The guideline already includes a section on setting goals for rehabilitation, which allows for personalised rehabilitation planning, and recommends that documentation about the person’s stroke rehabilitation should be individualised.

Predictive modelling to give better information to patients and carers about eventual outcome

No evidence in this area fulfilling the criteria of the current surveillance review was found.

Executive functioning

Evidence found in this area by the current surveillance review was not deemed sufficient to impact the guideline. A Cochrane review found insufficient high-quality evidence to reach any generalised conclusions, and 6 individual studies provided evidence of benefit, but the interventions were heterogeneous, and most did not examine outcomes specific to executive function.

Therapy apps for more self-directed rehabilitation

No evidence in this area fulfilling the criteria of the current surveillance review was found.

Activities of daily living are not limited to dressing

The guideline gives examples of occupational therapy strategies that include dressing, but the overarching recommendation covers any relevant occupational therapy and any difficulties with activities of daily living, not just dressing.

Return to driving

Evidence on driving rehabilitation was found by the current surveillance review, but not deemed sufficient to impact the guideline (which does not include driving rehabilitation, but does cross-refer to the Driver and Vehicle Licensing Agency [DVLA] about requirements for driving after stroke). Additionally, recommendation 1.11.3 contains an outdated link to a web page of DVLA requirements, which will be amended.

Stem cell therapy

No evidence in this area fulfilling the criteria of the current surveillance review was found.

New evidence and information

Several stakeholders referred to the NHS Long Term Plan (2019), and the Royal College of Physicians Intercollegiate Stroke Working Party (2016) National clinical guideline for stroke. These documents were considered by the surveillance review and are referred to at relevant points in appendix A: evidence summary. Additionally, NICE is planning to explore engaging with the Intercollegiate Stroke Working Party on any update of the guideline.

A stakeholder highlighted 2 publications stemming from the Spasticity in Stroke-Randomised Study (SISTERS) of the effects of intrathecal baclofen versus conventional medical management on post-stroke spasticity, pain and quality of life. These publications were not identified in the searches performed for the surveillance review and we have added them to the surveillance evidence summary. We acknowledge that the results show benefits of intrathecal baclofen, and we will add these publications to the surveillance evidence summary and consider their impact on the guideline as part of the update. The licence for intrathecal baclofen (Aguettant brand) states it is ‘…indicated in patients with severe chronic spasticity resulting from trauma […] who are unresponsive to oral baclofen or other orally administered antispastic agents and/or those patients who experience unacceptable side effects at effective oral doses. Baclofen Aguettant is effective in adult patients with severe chronic spasticity of cerebral origin, resulting e.g. from […] cerebrovascular accident; however, clinical experience is limited’.

Several stakeholders supplied other evidence not identified by the surveillance review. However, it was not suitable for inclusion in the review for various reasons (unpublished research, unsuitable evidence type, not in scope and outside search dates).

Merging the NICE guidelines on stroke and transient ischaemic attack in over 16s and stroke rehabilitation

We have no current plans to merge these guidelines, but the NICE Pathway on stroke brings together everything NICE has said on a topic in an interactive flowchart, and includes all the recommendations from both guidelines.

Third sector organisations

No evidence in this area fulfilling the criteria of the current surveillance review was found. However, the guideline already makes several recommendations of relevance to the third sector, and rehabilitation in partnership with voluntary organisations is advocated within the NHS Long Term Plan.

Assessment and management of disorders of oral feeding

Two stakeholders noted that the International Dysphagia Diet Standardisation Initiative has been updated and should be included in the guideline.

Recommendations on people with dysphagia after stroke who are having modified food and liquid, and nutrition support for people with dysphagia, are covered by the NICE guidelines on nutrition support for adults and stroke and transient ischaemic attack in over 16s (which are linked to from the NICE guideline on stroke rehabilitation). The stakeholder comments will be added to the issue log for these guidelines for consideration at their next surveillance review.

Medicines management

We asked stakeholders for feedback on whether medicines management issues that may arise in stroke rehabilitation are suitably covered by other NICE guidance such as the NICE guidelines on medicines adherence and medicines optimisation. One stakeholder responded with concerns about patients with stroke and their carers being confused about medicines (for example, patients on warfarin previously, when given a new anticoagulant may not appreciate these must not be taken together; similar confusion may exist about aspirin). They noted the need to provide written plans for patients and GPs at discharge with reference to high-risk medications. These issues are covered by the NICE guidelines on medicines adherence and medicines optimisation. The NICE guideline on stroke rehabilitation already links to the medicines adherence one, but we will add links to the medicines optimisation guideline.

Neuromuscular electrical stimulation

A stakeholder noted that neuromuscular electrical stimulation (NMES) should be included in the guideline. The evidence searches performed for the surveillance review identified several studies of electrical stimulation, including NMES for various aspects of stroke rehabilitation (swallowing therapy, shoulder pain and lower limb problems). The findings are presented in detail in appendix A: evidence summary. We do not anticipate any impact of the new evidence on the guideline at the present time.

Digital interventions

A stakeholder asked that emerging large-scale trials of digital interventions be reviewed. Any studies of digital interventions that were within the scope of the surveillance review and identified by surveillance review searches and intelligence gathering were included in the surveillance evidence summary. Some studies of computer-based interventions were included; however, the evidence either supported or was not sufficient to impact the guideline. We also track important ongoing studies, which includes an RCT of computer therapy identified by the stakeholder.

Acupuncture

A stakeholder queried why acupuncture was not included in the guideline update proposal. The surveillance review is based on protocols used by the original guideline (in which no review questions or studies were included for acupuncture or any other complementary and alternative medicine). Therefore, studies of complementary and alternative medicine were excluded from the surveillance review. However, we included the Cochrane review by Yang et al. (2016) on acupuncture for stroke rehabilitation in the surveillance review as an overview of the best available current evidence on this subject. The authors concluded that ‘most included trials were of inadequate quality and size. There is, therefore, inadequate evidence to draw any conclusions about its routine use’. This thus remains an area where not enough evidence of good quality is available to consider making recommendations.

Economic deprivation, ethnic minorities, and younger stroke survivors

Two stakeholders noted particular issues among these groups, for example, increased stroke risk, and worse outcomes and access to care. However, these issues are mainly related to stroke prevention (the scope of the NICE guideline specifically excludes primary and secondary prevention of stroke), and implementation issues. We will pass on issues regarding implementation of the guideline to the relevant team within NICE.

Providing 7-day stroke services

A stakeholder noted that many stroke units have significant workforce challenges (specialist staff in rehabilitation are often in short supply) and even if commissioned, the service may not be able to deliver sufficient staff to provide 7-day services. NICE guidance recommendations reflect best practice that services should aspire to. The final decision on new recommendation wording lies with the guideline committee who will develop the update. The committee may require more robust evidence on the effectiveness and cost effectiveness of recommendations that are expected to have a substantial impact on resources. This is defined as ‘implementing a single guideline recommendation in England costing more than £1 million per year, or implementing the whole guideline in England costing more than £5 million per year’ in NICE’s process and methods guide, developing NICE guidelines: the manual, chapter 7 on incorporating economic evaluation. We will pass on concerns about the availability of specialist staff to the developers of the guideline update.

Occupational therapy in care homes

A stakeholder queried why the update in this area relates only to care home residents (whereas frailty may be a more appropriate distinction) and only to occupational therapy (whereas there may be concerns around inequitable access to NHS care in general in care homes).

The proposed update in this area was based on a large RCT specifically of occupational therapy in care homes, therefore the surveillance proposal was based around this intervention and population. However, we additionally noted that expert comments within an NIHR signal about this trial stated that patients in the study were very frail and cognitively impaired, therefore it may be that any changes to recommendations in this area could be centred on physical attributes such as frailty rather than place of residence. We will ensure the developers for the update are aware of the comments from the stakeholder and the NIHR signal.

Regarding people in care homes receiving inequitable access to NHS care, recommendation 1.1.14 states ‘Ensure that people with stroke who are transferred from hospital to care homes receive assessment and treatment from stroke rehabilitation and social care services to the same standards as they would receive in their own homes’. This therefore relates to an implementation issue and we will pass this information on to the relevant team within NICE.

See appendix B for full details of stakeholders’ comments and our responses.

See ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual for more details on our consultation processes.

Editorial amendments by committee

It is proposed that the committee developing the updated guideline will consider a refresh of recommendation 1.2.1, to potentially include vision in the issues to be immediately screened for on admission to hospital to ensure immediate safety and comfort (vision assessment is currently covered by recommendation 1.2.2, which concerns the full medical assessment of the person with stroke).