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Publication Date: November 16, 2018

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CADTH RAPID RESPONSE REPORT: SUMMARY WITH CRITICAL APPRAISAL

Duration of Physiotherapy Rehabilitation after Acquired Brain Injury: A Review of Guidelines

SUMMARY WITH CRITICAL APPRAISAL Duration of Physiotherapy Rehabilitation after Acquired Brain Injury 2

Authors: Dinsie Williams, Monika Mierzwinski-Urban

Cite As: Duration of Physiotherapy Rehabilitation after Acquired Brain Injury: A Review of Guidelines. Ottawa: CADTH; 2018 Nov (CADTH rapid response

report: summary with critical appraisal).

ISSN: 1922-8147 (online)

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Abbreviations

ABI acquired brain injury AHA/ASA American Heart Association/American Stroke Association GRADE Grading of Recommendations, Assessment, Development and Evaluation INESSS Institut National d’Excellence en Santé et en Service Social NICE National Institute for Health and Care Excellence ONF Ontario Neurotrauma Foundation RCT randomized controlled trials TBI traumatic brain injury

Context and Policy Issues

Acquired brain injury (ABI) may be caused by traumatic injury or non-traumatic events and

can result in conditions ranging from motor, sensory, or cognitive impairment to variably

prolonged coma.1 The annual incidence of traumatic brain injury (TBI) specifically, is

conservatively estimated at up to 600 per 100,000 people across North America and

Europe.2 The incidence of TBI is increasing in Canada, representing 9.6% of all reported

serious injuries.3

Stroke affects 50,000 Canadians each year4 and is a common precursor to brain injury.

Together with other cerebrovascular diseases, stroke is the third leading cause of death in

Canada and the leading cause of disability in the adult population, with over 400,000

Canadians living with the effects of stroke.5,6 The impact of stroke includes, but is not

limited to, spasticity, limited mobility or dysfunction in the upper and lower extremities, pain,

dysphagia, and impaired vision, communication, and perception.7 From a societal

perspective in Canada, the annual cost of caring for patients with stroke and the loss of

productivity is approximately $3.6 billion.7 Physiotherapy, along with occupational therapy

and speech and language therapy, delivered in either a hospital or community setting may

be used to provide rehabilitation of patients who have had a stroke or ABI.8

The aim of this report is to review the relevant evidence-based guidelines regarding the

duration and frequency (or intensity) of physiotherapy for the rehabilitation for adults with

ABI.

Research Question

What are the evidence-based guidelines regarding the duration and frequency of

physiotherapy treatment/rehabilitation for adults with acquired brain injury?

Key Findings

The review found eight guidelines that offered recommendations on the duration and/or

frequency/intensity of rehabilitation for acquired brain injury (from stroke or other means).

Wherever possible, recommendations on physiotherapy or elements of physical activity

were extracted from the list of rehabilitation recommendations.

For patients with traumatic or acute brain injury, one set of guidelines recommends 30

minutes a day of standing therapy for five days a week, to decrease or eliminate ankle

contracture while another recommends a minimum of three hours per day of rehabilitation

to improve function. The recommendation on standing therapy was tempered by low quality


evidence suggesting that 30 minutes of standing for three days a week may worsen

orthostatic hypotension and cause an increase in pain in some patients.

For patients who have had a stroke, high quality evidence supports recommendations for

30 minutes of standing therapy offered five times a week, to help maintain ankle range of

motion and general activity. Additionally, 20 to 40 minutes of continuous aerobic exercise

offered three to five times a week to patients who can tolerate that level of intensity may

improve health outcomes and quality of life. Based on low level evidence, the Canadian

Stroke Best Practice Recommendations guidelines and the Stroke Foundation (Australia)

support three hours of rehabilitation per day. Based on moderate level evidence, the

American Heart Association/American Stroke Association recommends 30 minutes of

therapy for a hemiplegic shoulder condition and a four-week exercise program for post-

stroke depression. The National Institute for Health and Care Excellence in the UK

recommends at least 45 minutes of each relevant stroke rehabilitation therapy for a

minimum of five days per week if patients can sustain that level of intensity and continue to

meet their functional goals. Importantly, four out of six guidelines that outlined

recommendations for duration and intensity of rehabilitation therapy for patients with stroke

suggest tailoring rehabilitation to meet the individual needs, goals, anticipated benefit, and

tolerance of each patient.

Overall, the authors followed established processes for developing guidelines, however

there were some gaps in reporting that made it challenging to assess all aspects of the

development processes. As a result of the heterogeneity in study characteristics, variation

in the quality of the evidence, and the variability in the methods used to rate and synthesize

the available evidence, the recommendations varied in strength and content. Given this

variability in the recommendations, policy makers may need to deliberate extensively when

making decisions regarding duration and frequency (or intensity) of rehabilitation for

persons with ABI in Canada.

Methods

Literature Search Methods

A limited literature search was conducted on key resources including Ovid Medline,

PubMed, the Cochrane Library, University of York Centre for Reviews and Dissemination

(CRD) databases, Canadian and major international health technology agencies, as well as

a focused Internet search. Methodological filters were applied to limit retrieval to guidelines.

The search was also limited to English language documents published between January 1,

2013 and October 22, 2018.

Selection Criteria and Methods

One reviewer screened citations and selected studies. In the first level of screening, titles

and abstracts were reviewed and potentially relevant articles were retrieved and assessed

for inclusion. The final selection of full-text articles was based on the inclusion criteria

presented in Table 1.


Table 1: Selection Criteria

Population Adults with acquired brain injuries (e.g., post-stroke)

Intervention Physiotherapy and rehabilitation

Comparator Not applicable

Outcomes Guidelines on duration and frequency of physiotherapy

Study Designs Guidelines

Exclusion Criteria

Articles were excluded if they did not meet the selection criteria outlined in Table 1, if they

were duplicates or if they were published prior to 2013. Guidelines were excluded if they did

not incorporate a systematic review of the published literature or if they did not discuss or

report on duration and frequency of physiotherapy or rehabilitation.

Critical Appraisal of Individual Studies

All guidelines were critically appraised by one reviewer using the AGREE II instrument.9

Summary scores were not calculated for the included studies; rather, a review of the

strengths and limitations of each included study were described narratively.

Summary of Evidence

Quantity of Research Available

A total of 117 citations were identified in the literature search. Following screening of title

and abstracts, 96 citations were excluded and 21 potentially relevant reports from the

electronic search were retrieved for full-text review. Five potentially relevant publications

were retrieved from the grey literature search for full-text review. Of these 26 potentially

relevant articles, 18 publications were excluded for various reasons, and eight publications

met the inclusion criteria for this report. Appendix 1 presents the PRISMA10 flowchart of the

study selection.

Additional references of potential interest are provided in Appendix 5.

Summary of Study Characteristics

Study characteristics are summarized below and details are available in Appendix 2, Table

2.

Study Design

Eight relevant guidelines were identified that addressed the duration and frequency of

rehabilitation for patients with ABI or stroke.7,11,12 8,13-16 One of the documents presented

practical suggestions or recommendations for prescribing aerobic exercise.16

One guideline development group conducted a scoping review of clinical practice guidelines

spanning 2000 to 2004,14 while two others conducted informal reviews of the literature,12,15

with one spanning literature published form an unknown date through 2014.12 The

remainder conducted systematic reviews of the literature spanning 2012 to 2015,7 1980 to


2015,13 an unknown date up to October 2011,16 and an unknown date up to October 2012.8

One group did not describe their evidence collection and selection process.11

The guideline development groups based their quality assessment on the Grading of

Recommendations, Assessment, Development and Evaluation (GRADE) methodology,8,11

the Practice Guideline Evaluation and Adaptation Cycle,7 the joint American Heart

Association (AHA)/American College of Cardiology and supplementary AHA methods,12

Oxford Centre for Evidence Based Medicine Levels and a domain-based risk-of-bias rating

system,13 the Institut National d’Excellence en Santé et en Service Social/Ontario

Neurotrauma Foundation (INESSS/ONF) levels of evidence,14 and the Physiotherapy

Evidence Database (PEDro) assessment approach.16

The development and evaluation of recommendations were guided by the GRADE

methodology,11,13 the AHA framework,12 a modified Dephi or other consensus process,7,8,15

or a guidelines adaptation cycle process.14 One group did not describe the process through

which recommendations were developed or evaluated.16

The guidelines were validated through internal review,7,12 external review by experts,7,12,14

external review through public consultation,8 or through comparison with published

literature.13 Three groups did not describe how their recommendations were

validated.11,15,16

Country of Origin

The guidelines were developed by lead authors located in Australia,11 Canada7,14, China

(Hong Kong),16 the United Kingdom,8,15 and the US.12,13 The guidelines were funded or

conducted by various bodies including, the government of Australia to support healthcare

professionals, administrators, funders, and policy makers,11 the Heart and Stroke

Foundation of Canada for use by patients, families/caregiver(s), and clinicians in Canada

and elsewhere,7 the AHA/American Stroke Association (ASA) for use by healthcare

professionals and patients in the US,12 INESSS and ONF for publicly funded rehabilitation

in Canada (specifically, in Ontario and Quebec),14 the Public Health Agency of Canada,16

the National Institute for Health and Care Excellence in the UK,8 and the National Institute

for Health Research Collaboration for Leadership in Applied Health Research and Care for

Nottinghamshire, Derbyshire and Lincolnshire in the UK.15 The National Coalition for

Assistive and Rehab Technology paid the publication fees for one set of guidelines that

focused on the use of a standing device globally.13

Patient Population

One set of guidelines focused on patients with moderate or severe TBI14 while the rest

targeted patients who had had a stroke with 13 or without 7,8,11,12,15,16 spinal cord injury and

other neurological conditions. One set of guidelines included people who had had a

transient ischemic attack.11

Four of the guidelines were written for adult populations,11-14 while the remaining guidelines

did not indicate the age of the target population.7,8,15,16

Interventions and Comparators

The interventions of interest were stroke rehabilitation,7,11,12,14 community-based

rehabilitation,15 and long-term rehabilitation.8 Wherever possible, recommendations on

physiotherapy or elements of physical activity were extracted from the list of rehabilitation


recommendations. One guideline focused specifically on the use of a supported standing

device13 while another focused on aerobic exercise.16

Outcomes

The outcomes of interest were recommendations that focused on the use of rehabilitation to

improve cognitive status14,16 functionality,7,15,16 range of motion,13 activity,13 aerobic

fitness,16 cardiovascular and psychosocial functionality,16 bone mineral density13 or quality

of life,16 and/or to reduce spasticity13 or contracture.12 A set of guidelines that were

commissioned by the National Institute for Health and Care Excellence (NICE) focused on

mortality, dependency, and requirement for institutional care and length of hospital stay.8

Only outcomes that were relevant to the duration and frequency (or intensity) of

physiotherapy rehabilitation were included in this report.

The evidence that informed the guidelines was graded with a variety of tools as described

in the Summary of Findings section.

Summary of Critical Appraisal

For each guideline document, the following domains were appraised: scope and purpose,

stakeholder involvement, rigour and development, clarity of presentation, applicability, and

editorial independence. Details of the critical appraisal are described in Appendix 3, Table

3.

The 2017 Australian Clinical Guidelines for Stroke Management11 followed the GRADE

methodology for developing and rating recommendations. The quality of the guidelines

could not be adequately assessed using the AGREE II checklist as the guideline document

referred to the GRADE website for a description of how the methodology was used.9

Information was unavailable to assess the membership of the guideline development group,

inclusion of the views and preferences of the target population, identification and inclusion

of evidence, and the incorporation of side effects and risks in the formulation of the

recommendations. Nonetheless, the Australian National Health and Medical Research

Council (“the Council”) approved the guideline recommendations indicating that they were

systematically derived, and were based on identification and synthesis of the best available

scientific evidence. A procedure for updating the guidelines was not provided although the

Council expects an update will be conducted within five years. Tools to support

implementation were provided however a list of barriers and facilitators were not.

The 2015 update of the Canadian Stroke Best Practice Recommendations (rehabilitation)

that was published in 20167 met all but two of the criteria on the AGREE II checklist. The

views and experiences of individuals who had experienced stroke were not explicitly

sought, even though individuals who had experienced a stroke or their families were said to

be part of the guideline group and/or external reviewers. In addition, while a systematic

literature search was conducted and the level of evidence was based on the types of

studies that were included, the criteria used to select the evidence were not described.

The 2016 AHA/ASA guidelines for adult stroke rehabilitation and recovery did not fully

describe its development process.12 The affiliations and conflict of interest disclosures were

provided for each member of the guideline development group, however, the authors of the

document did not describe their specific occupations and the process through which the

recommendations were formulated. The authors did not indicate whether the views and

preferences of the target population were sought; and did not describe the criteria that were

used to select literature or a procedure for updating the guidelines. From the information


that was available, it was unclear whether the development group included individuals from

all relevant professional groups or whether the literature search was systematic. Regarding

applicability, the document did not provide advice and/or tools for implementing the

recommendations or criteria for monitoring and/or auditing the implementation.

Two authors were involved in the development of the guidelines published by Paleg and

Linvingstone.13 Their recommendations did not undergo peer review, and a process for

revising the document was not outlined. The recommendations were limited to the use of a

standing device as an intervention, and as such alternate management options were not

considered. The recommendations did not meet any of the criteria for applicability. In

addition, the views and preferences of the target group were not sought nor were the target

users described. While there is no information to assess external influence on the

guidelines, the National Coalition for Assistive and Rehab Technology paid the fee to have

the guidelines published. Recommendations in favour of using rehabilitation procedures

and tools could potentially be beneficial to the Coalition.

The INESSS/ONF guidelines were derived from searching multiple databases for published

clinical practice guidelines, however the authors did not describe the criteria that were used

to select and extract information from the guidelines. The recommendations were listed

separately from the evidence from which they were derived therefore it is not possible to

identify explicit links between the recommendations and the supporting evidence. The

facilitators and barriers to implementing the recommendations were not indicated although

the authors provided a number of tools and resources to support implementation. The

potential resource implications of applying the recommendations were not compiled, which

leaves the user with the responsibility for determining resource requirements associated

with each implementation tool. Finally, it is unclear whether the funding bodies (INESSS

and ONF) influenced the content of the guideline given that the governance body that was

responsible for overall guidance of the guideline development process included members

from both organizations.

The recommendations developed by Fisher et al. were compiled to establish the core

components of evidence-based community stroke services through a modified Delphi

consensus process.15 Several important elements were missing from the document, such

as the health questions, inclusion of the views and experiences of the target population, a

review by external experts, a presentation of different options for stroke management,

advice or tools for putting the recommendations into practice, and monitoring and auditing

criteria. Furthermore, the search for published evidence was not systematic, the strengths

and limitations of the body of evidence were not described, side effects and risks were not

considered when formulating the recommendations, and the recommendations were not

explicitly linked to the evidence. Although an external review was not conducted, the

consensus panel of 26 individuals was not part of the core team that developed the initial

recommendation statements. Panel members were selected by the core team based on

each person’s knowledge of national stroke policy, their perceived ability to respond to

statements from a national perspective, their field of expertise or knowledge of research

literature and leadership experience within stroke care.

The evidence-based exercise prescription recommendations did not define the target users

and it was unclear whether individuals from all relevant professional groups were included

in developing the recommendations.16 The method through which the recommendations

were formulated and a procedure for updating the list of recommendations was not

described. The document did not meet any of the criteria for applicability that are outlined in


the AGREE II checklist. As such, facilitators and barriers to implementation, advice or tools

on implementation, resource implications, and monitoring or auditing criteria were not

described.

The NICE stroke rehabilitation guidelines targeted physical, cognitive and speech functions,

activities of daily living and vocational rehabilitation, dysphagia and visual field loss in adults

and young people 16 years or older with continued impairment following a stroke.8

Additionally, information on support for patients and care providers, early supported

discharge and intensity of rehabilitation therapy were included. While the guidelines were

comprehensive, there were key gaps in their quality. Although the authors indicated that

stakeholders were consulted throughout the guideline development process, the individuals

were not identified. Additionally, the criteria for selecting evidence, side effects, risks, the

facilitators and barriers to implementing the guidelines, the potential resource implications,

and auditing criteria were not presented. Finally, it was unclear whether the views and

preferences of the target population were sought; even though one patient was included in

the guideline development group. No information was provided on how or if that person’s

views and preferences were incorporated into the guidelines. Statements regarding the

potential for the funding body to influence the content of the guidelines and competing

interests of the members of the guideline group were not included.

Summary of Findings

Appendix 4 Table 4 presents the main study findings and authors’ conclusions.

Guidelines

The 2017 evidence-based Stroke Foundation’s clinical guidelines for stroke management

were developed to assist decision-making in the management of stroke and transient

ischaemic attack in Australian adults.11 The guidelines provide a strong recommendation for

offering as much scheduled occupational therapy and physiotherapy as possible to those

who have experienced a stroke. The recommendation to offer a minimum of three hours a

day of scheduled occupational therapy and physiotherapy, ensuring at least two hours of

active task practice at each session was rated as weak. The recommendations were rated

based on the GRADE methodology. Strong recommendations indicate that authors are

certain that the evidence supports a clear balance towards either desirable or undesirable

effects while weak recommendations suggest that the authors are uncertain about the

balance between desirable and undesirable effects.

The 2015 update of the Canadian stroke rehabilitation practice guidelines provide up-to-

date evidence-based guidelines on every aspect of stroke care, from prevention through

treatment, rehabilitation, transitions of care, and telemedicine.7 Specific to duration of in-

house rehabilitation, based on level C evidence, the guidelines recommend a minimum of

three hours per day of direct task-specific therapy, five days a week for all patients.7

Although additional evidence (level A) suggested that more therapy resulted in better

outcomes, the authors also recommend that intensity and duration be tailored to the needs

and tolerance of the individual patient.7 For outpatient and community-based rehabilitation,

45 minutes per day of each type of therapy (level B evidence) is recommended at a

frequency of two to five days per week for a total of eight weeks (level C evidence). The

authors recommend tailoring the number of days of therapy to the needs and goals of the

individual patient (level A evidence).7 Level A refers to evidence from a meta-analysis of

RCTs or consistent findings from two or more RCTs. In addition, desirable effects clearly

outweigh undesirable effects or undesirable effects clearly outweigh desirable effects. Level


B refers to evidence one RCT or consistent findings from two or more well-designed non-

randomized and/or non-controlled trials, and large observational studies. At this level,

desirable effects outweigh or are closely balanced with undesirable effects or undesirable

effects outweigh or are closely balanced with desirable effects. Level C refers to evidence

developed through writing group consensus and/or supported by limited research evidence.

At this level, desirable effects outweigh or are closely balanced with undesirable effects or

undesirable effects outweigh or are closely balanced with desirable effects, as determined

by writing group consensus.

Winstein et al. developed guidelines for adult stroke rehabilitation and recovery in the

United States.12 The guidelines were commissioned by the AHA/ASA and endorsed by the

American Academy of Physical Medicine and Rehabilitation and the American Society of

Neurorehabilitation. Based on class I, level B evidence, the guidelines recommend inpatient

hospital rehabilitation at an intensity level commensurate with anticipated benefit and

tolerance of the individual. To prevent skin breakdown and contractures, the guidelines

suggest positioning of a hemiplegic shoulder in maximum external rotation while the patient

is either sitting or in bed for 30 minutes daily is probably indicated (based on class IIa, level

B evidence). For post-stroke depression, an exercise program of at least four weeks

duration may be considered as a complementary treatment (based on class IIb, level B

evidence). The guidelines document notes that US medicare regulations require that

inpatient rehabilitation facilities provide at least three hours of rehabilitation therapy per day

for at least five days per week. Rehabilitation therapy included physiotherapy, occupational

therapy, and speech and language therapy. Intake to inpatient rehabilitation facilities was

limited to patients for whom significant improvement was expected within a reasonable

length of time. A specific time period was not specified. For these guidelines, Level A refers

to evidence from multiple randomized controlled trials (RCTs), level B refers to evidence

one RCT or from non-randomized studies, and level C refers to evidence developed

through consensus of experts, case studies or standard of care. As the class number

moves from I to III, the benefit decreasingly outweighs the risk where class III evidence

demonstrates harm or no benefit from the intervention.

Two authors, Paleg and Livingstone compiled clinical recommendations for the duration of

supported home-based standing programs for adults aged 19 years or older with stroke,

spinal cord injury, and other neurological conditions.13 They systematically searched and

evaluated primary studies including adults with chronic conditions or who could engage in

active rehabilitation. The authors recommend that a standing device should be used for 30

minutes, five times a week for positive impact on self-care and standing balance, range of

motion, cardio-respiratory, strength, spasticity, pain, and skin, bladder, and bowel function

while 60 minutes, four to six times a week may be required for positive impact on bone

mineral density and mental function. Specific to stroke, the authors indicate that there was

high quality evidence to suggest 30 minutes of standing five times a week helped patients

maintain ankle range of motion and general activity, while there was low quality of evidence

to suggest that 20 to 30 minutes daily resulted in static standing orthostatic hypotension in

52% of a test population. Specific to traumatic or acute brain injury, evidence of unclear

quality suggests that 30 minutes a day of standing five days a week decreases or

eliminated ankle contracture; low quality evidence suggests that 30 minutes a day of static

standing three days a week worsened orthostatic hypotension in 75% of patients (the total

was not reported); and very low quality of evidence suggests that 30 minutes of standing

three to six times per week could be tolerated before patients with TBI started to experience

increase in pain. The Oxford Centre for Evidence Based Medicine Levels were used to


determine the levels of evidence while GRADE was used to rate the strength of the

recommendations.

The INNESSS-ONF clinical practice guidelines for the rehabilitation of adults with moderate

to severe TBI recommend a minimum of three hours per day of therapeutic interventions

based on level C evidence.14 In addition, also based on level C evidence, the guidelines

recommend tailoring the length of stay in inpatient rehabilitation to the individual’s functional

status. Level A evidence involves at least one meta-analysis, a systematic review, or an

RCT of appropriate size with a relevant control group. Level B evidence included cohort

studies that at minimum have a comparison group, well-designed single subject

experimental designs, or small sample size randomized controlled trials. Level C evidence

includes primarily by expert opinion based on their experience, though uncontrolled case

series without comparison groups that support the recommendations are also classified

here.

Based on a consensus process, Fisher et al. recommend that people who have

experienced a stroke living in the community should receive tailored rehabilitation at

intensity levels commensurate with their individual clinical needs, goals and outcomes.15

The consensus panel rejected initial recommendations that specified time limits on the

duration of rehabilitation. Of 26 panel members, 96% agreed with the recommendation

statement.

To improve health outcomes and quality of life after stroke, Pang et al., recommend 20 to

40 minutes of continuous aerobic exercise, (such as, using a treadmill, cycle ergometer, or

performing functional activities), three to five days per week (level A recommendation).16

The authors recommend that for high-risk patients or those who have had an acute stroke,

treatment should occur in a clinical setting, under supervision. Low-risk patients should also

be treated under supervision but may receive treatment in a community care setting or at

home. The rating that was assigned to the recommendation indicates that benefits clearly

outweigh the risks.

The NICE guidelines for stroke rehabilitation recommend tailoring duration to the ability of

patients.8 Initially, patients may be offered 45 minutes of each relevant rehabilitation

therapy, five days per week if they can sustain the intensity and continue to meet their

functional goals. The length of each session may be increased if more rehabilitation can be

tolerated or decreased for patients who are unable to participate in 45 minutes of therapy

soon after experiencing a stroke. The variation in intensity is recommended despite the

uncertainty about the benefits of increasing the intensity (in hours per day) or duration of

therapy (in weeks). The guideline development group notes that more evidence on intensity

of rehabilitation is needed. As such, a level of confidence was not assigned to the

recommendation although the GRADE rating system was available to the group.

Limitations

There are limitations with regard to the volume of evidence, heterogeneity in populations of

interest and interventions, differences in guideline development processes, and

subsequent variability in recommendations.

Eight guidelines were included in this review written by authors representing five countries.

The body of evidence did not explicitly limit the intervention to physiotherapy for patients

with ABI. Only one set of guidelines focused specifically on physiotherapy as an

intervention.11 Three focused on exercise12,16 or standing13. One of these was


commissioned to provide practical suggestions or prescription recommendations.16 Three

others reported on non-specific rehabilitation (which may include physiotherapy) as an

intervention.7,14,15 Furthermore, only two13,14 out of eight documents outlined

recommendations for duration and frequency of rehabilitation for patients with traumatic

and/or acute brain injury, not limited to stroke.

Overall, the authors followed established processes for developing guidelines, however

there were some gaps in reporting that made it challenging to assess all aspects of the

development processes. As a result of the heterogeneity in study characteristics, variation

in the quality of the evidence, and the variability in the methods used to rate and synthesize

the available evidence, the recommendations varied across the studies. Two of the

guidelines were written in Canada and published in the same year; they produced similar

but not identical recommendations.7,14

Conclusions and Implications for Decision or Policy Making

The review found eight guidelines that offered clear recommendations on the duration and

frequency (or intensity) of physiotherapy rehabilitation for ABI (from stroke or other means).

Based on varying levels of evidence, one set of the Canadian guidelines recommends

offering direct task-specific therapy for three hours per day at a frequency of five days a

week to those who have experienced a stroke.7 The guidelines simultaneously recommend

tailoring rehabilitation to the individual needs based on higher level of evidence.7 The

second Canadian guidelines recommend a minimum of three hours per day of undefined

rehabilitation for patients with TBI.14 Guidelines that focused on patients with traumatic or

acute brain injury recommended 30 minutes a day of standing offered at a frequency of five

days a week to decrease or eliminate ankle contracture. Incidentally, the authors noted that

there was low quality evidence suggesting that three days a week at this intensity worsened

orthostatic hypotension in 75% of patients and that patients generally experience an

increase in pain within three to six days.13

Given the variability in the recommendations reported by the guidelines, policy makers may

need to deliberate extensively when making decisions regarding duration and frequency (or

intensity) of rehabilitation for ABI in Canada. The level of uncertainty in the evidence may

contribute to variation among provinces and territories in the implementation of

rehabilitation for persons with ABI.


References

1. De Tanti A, Zampolini M, Pregno S, Group CC. Recommendations for clinical practice and research in severe brain injury in intensive rehabilitation: the Italian Consensus Conference. Eur J Phys Rehabil Med. 2015;51(1):89-103.

2. Canadian Institutes of Health Research. Research in traumatic brain Injury. 2012; http://www.cihr-irsc.gc.ca/e/45665.html. Accessed 2018 Nov 16.

3. Rao DP, McFaull S, Thompson W, Jayarama GC. At-a-glance – traumatic brain injury management in Canada: changing patterns of care. 2018; https://www.canada.ca/en/public-health/services/reports-publications/health-promotion-chronic-disease-prevention-canada-research-policy-practice/vol-38-no-3-2018/traumatic-brain-injury-management-canada.html. Accessed 2018 Nov 16.

4. Nelson ML, Grudniewicz A, Albadry S. Applying clinical practice guidelines to the complex patient: insights for practice and policy from stroke rehabilitation. Healthc Q. 2016;19(2):38-43.

5. Different strokes: recovery triumphs and challenges at any age. 2017 stroke report. Ottawa (ON): Heart and Stroke Foundation of Canada; 2017: http://www.heartandstroke.ca/-/media/pdf-files/canada/stroke-report/strokereport2017en.ashx?la=en&hash=67F86E4C3338D5A7FE7862EA5D0DD57CA8539847. Accessed 2018 Nov 16.

6. Government of Canada. Stroke in Canada: highlights from the Canadian Chronic Disease Surveillance System. 2017; https://www.canada.ca/en/public-health/services/publications/diseases-conditions/stroke-canada-fact-sheet.html. Accessed 2018 Nov 16.

7. Hebert D, Lindsay MP, McIntyre A, et al. Canadian stroke best practice recommendations: stroke rehabilitation practice guidelines, update 2015. Int J Stroke. 2016;11(4):459-484.

8. National Clinical Guideline Centre (UK). Stroke rehabilitation: long term rehabilitation after stroke. London: Royal College of Physicians (UK); 2013: https://www.ncbi.nlm.nih.gov/pubmed/25340225. Accessed 2018 Nov 16.

9. Agree Next Steps Consortium. The AGREE II Instrument. Hamilton (ON): AGREE Enterprise; 2017: https://www.agreetrust.org/wp-content/uploads/2017/12/AGREE-II-Users-Manual-and-23-item-Instrument-2009-Update-2017.pdf. Accessed 2018 Nov 16.

10. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62(10):e1-e34.

11. Stroke Foundation. Clinical guidelines for stroke management. 2017; https://informme.org.au/en/Guidelines/Clinical-Guidelines-for-Stroke-Management-2017 Accessed 2018 Nov 16.

12. Winstein CJ, Stein J, Arena R, et al. Guidelines for adult stroke rehabilitation and recovery: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2016;47(6):e98-e169.

13. Paleg G, Livingstone R. Systematic review and clinical recommendations for dosage of supported home-based standing programs for adults with stroke, spinal cord injury and other neurological conditions. BMC Musculoskelet Disord. 2015;16:358.

14. Institut national d’excellence en santé et en services sociaux (INESSS). Clinical practice guideline for the rehabilitation of adults with moderate to severe TBI. 2016; https://braininjuryguidelines.org/modtosevere/. Accessed 2018 Nov 16.

15. Fisher RJ, Walker MF, Golton I, Jenkinson D. The implementation of evidence-based rehabilitation services for stroke survivors living in the community: the results of a Delphi consensus process. Clin Rehabil. 2013;27(8):741-749.

16. Pang MY, Charlesworth SA, Lau RW, Chung RC. Using aerobic exercise to improve health outcomes and quality of life in stroke: evidence-based exercise prescription recommendations. Cerebrovasc Dis. 2013;35(1):7-22.

http://www.cihr-irsc.gc.ca/e/45665.htmlhttps://www.canada.ca/en/public-health/services/reports-publications/health-promotion-chronic-disease-prevention-canada-research-policy-practice/vol-38-no-3-2018/traumatic-brain-injury-management-canada.htmlhttps://www.canada.ca/en/public-health/services/reports-publications/health-promotion-chronic-disease-prevention-canada-research-policy-practice/vol-38-no-3-2018/traumatic-brain-injury-management-canada.htmlhttp://www.heartandstroke.ca/-/media/pdf-files/canada/stroke-report/strokereport2017en.ashx?la=en&hash=67F86E4C3338D5A7FE7862EA5D0DD57CA8539847http://www.heartandstroke.ca/-/media/pdf-files/canada/stroke-report/strokereport2017en.ashx?la=en&hash=67F86E4C3338D5A7FE7862EA5D0DD57CA8539847https://www.canada.ca/en/public-health/services/publications/diseases-conditions/stroke-canada-fact-sheet.htmlhttps://www.ncbi.nlm.nih.gov/pubmed/25340225https://www.agreetrust.org/wp-content/uploads/2017/12/AGREE-II-Users-Manual-and-23-item-Instrument-2009-Update-2017.pdfhttps://www.agreetrust.org/wp-content/uploads/2017/12/AGREE-II-Users-Manual-and-23-item-Instrument-2009-Update-2017.pdfhttps://informme.org.au/en/Guidelines/Clinical-Guidelines-for-Stroke-Management-2017https://informme.org.au/en/Guidelines/Clinical-Guidelines-for-Stroke-Management-2017https://braininjuryguidelines.org/modtosevere/


Appendix 1: Selection of Included Studies

96 citations excluded

21 potentially relevant articles retrieved for scrutiny (full text, if available)

5 potentially relevant reports retrieved from other sources (grey

literature, hand search)

26 potentially relevant reports

18 reports excluded: -irrelevant population (2) -irrelevant intervention (2) -irrelevant outcomes (5) -other (review articles, editorials)(9)

8 reports included in review

117 citations identified from electronic literature search and screened


Appendix 2: Characteristics of Included Publications

Table 2: Characteristics of Included Guidelines Intended Users, Target Population

Intervention and Practice Considered

Major Outcomes Considered

Evidence Collection, Selection, and Synthesis

Evidence Quality Assessment

Recommendations Development and Evaluation

Guideline Validation

Stroke Foundation, 201711

Healthcare professionals, administrators, funders and policy makers who plan, organize and deliver care for people with stroke or transient ischemic attack during all phases of recovery

Stroke management

Rehabilitation Not reported GRADE methodology

GRADE methodology

Not described

Hebert (Canadian Stroke Best Practice Recommendations), 20167

Patient, family, informal caregivers, interprofessional rehabilitation team, health system planners, funders, administrators, and other healthcare professionals, patients of all ages with stroke

Stroke rehabilitation

Cognitive and functional status

Conducted systematic literature search to identify research evidence; convened rehabilitation experts and stroke survivors or their family members met to review, draft, and revise recommendation statements; consulted other experts

Modified Practice Guideline Evaluation and Adaptation Cycle (Based on included study designs and size of effect of the intervention)

By consensus Internal review, external review by Canadian and international experts

Winstein (AHA/ASA), 201612

Healthcare professionals, adults recovering from stroke

Stroke rehabilitation

Contracture The guideline panel reviewed relevant articles on adults using computerized searches of the medical literature through 2014

Joint AHA/American College of Cardiology and supplementary AHA methods

AHA framework Internal review at the AHA, external peer review

Paleg and Livingstone, 201513


Intended Users, Target Population







Intended users were not described, targeted population included adults aged 19 years or older

Supported home-based standing programs for adults with stroke, spinal cord injury and other neurological conditions

Improvement in range of motion, bone mineral density and activity, and reduction of spasticity

Systematic review, independent selection and data extraction by two researchers

Oxford Centre for Evidence Based Medicine Levels and a domain-based risk-of bias approach

Strength of recommendation was rated using GRADE and the Evidence Alert Traffic-Lighting System

Comparison with published literature. Formal validation was not conducted

INESSS/ONF, 201614

Front-line clinicians, program coordinators and managers working in publicly funded rehabilitation acute or post-acute inpatient, or outpatient/community settings, or providing TBI rehabilitation in acute care facilities, patients with TBI (specifically in Ontario and Quebec)

Rehabilitation for adults aged 18 to 65 years with moderate to severe TBI

Cognitive function and other unidentified outcomes

Scoping review for clinical practice guidelines spanning 2000 to 2014

INESSS-ONF levels of evidence

Guidelines adaptation cycle process

Consultation in clinical settings to assess the differences between current practices and recommend-ations, and to ascertain priorities

Fisher, 201315

Healthcare providers Community stroke services

General recovery

Literature review, statements were generated and discussed

Not described Modified Delphi consensus process

Not described

Pang, 201316

Intended users were not described. The targeted population included people with stroke

Aerobic exercise for stroke rehabilitation

Aerobic fitness and health indicators in cardiovascular, psychosocial and cognitive domains, functional ability and quality of life

Systematic review of published literature, independent article selection and data extraction by two researchers with third party confirmation, meta-analyses were conducted if five or more studies reported

PEDro score for each study followed by a letter grade assigned to evidence for each outcome

Not described Not described


Intended Users, Target Population







on the same outcome

NICE, 20138

Health care professionals, adults and young people 16 years and older who had a stroke with continuing impairment two weeks or more after the stroke, limited activity or participation restriction

Intensive rehabilitation after stroke

Physical, cognitive and speech functions, activities of daily living and vocational rehabilitation, dysphagia and visual field loss

Systematic literature review, including critical appraisal and meta-analysis where appropriate of clinical effectiveness and cost-effectiveness data from RCTs; review of existing systematic reviews and guidelines

GRADE was applied to each outcome

A multidisciplinary guideline development group comprising professional group members and consumer representatives of the main stakeholders (stroke rehabilitation clinicians and other professionals with significant experience in stroke rehabilitation); modified Delphi process

Validated through an eight week public consultation and feedback

AHA/ASA = American Heart Association/American Stroke Foundation; GRADE = Grading of Recommendations Assessment, Development and

Evaluation; INESSS = Institut National d’Excellence en Santé et en Service Social; NICE = National Institute for Health and Care Excellence; ONF =

Ontario Neurotrauma Foundation; PEDro = Physiotherapy Evidence Database; TBI = traumatic brain injury


Appendix 3: Critical Appraisal of Included Publications

Table 3: Strengths and Limitations of Guidelines using AGREE II9

Item

Guideline

Stroke Foundation,

201711

Hebert (Canadian Stroke Best

Practice Recommendations),

2016 7

Winstein (AHA/ASA),

201612

Paleg and Livingstone,

201513

Domain 1: Scope and Purpose

1. The overall objective(s) of the guideline is (are) specifically described.

+ + + +

2. The health question(s) covered by the guideline is (are) specifically described.

+ + + +

3. The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described.

+ + + +

Domain 2: Stakeholder Involvement

4. The guideline development group includes individuals from all relevant professional groups.

? + ? -

5. The views and preferences of the target population (patients, public, etc.) have been sought.

? - - -

6. The target users of the guideline are clearly defined. + + + -

Domain 3: Rigour of Development

7. Systematic methods were used to search for evidence. ? + ? +

8. The criteria for selecting the evidence are clearly described. ? - - +

9. The strengths and limitations of the body of evidence are clearly described.

+ + + +

10. The methods for formulating the recommendations are clearly described.

+ + - +

11. The health benefits, side effects, and risks have been considered in formulating the recommendations.

? + + +

12. There is an explicit link between the recommendations and the supporting evidence.

+ + + +


Item

Guideline

Stroke Foundation,

201711



2016 7

Winstein (AHA/ASA),

201612


201513

13. The guideline has been externally reviewed by experts prior to its publication.

? + + -

14. A procedure for updating the guideline is provided. - + - -

Domain 4: Clarity of Presentation

15. The recommendations are specific and unambiguous. + + + +

16. The different options for management of the condition or health issue are clearly presented.

+ + + -

17. Key recommendations are easily identifiable. + + + +

Domain 5: Applicability

18. The guideline describes facilitators and barriers to its application.

- +/- + -

19. The guideline provides advice and/or tools on how the recommendations can be put into practice.

+ + - -

20. The potential resource implications of applying the recommendations have been considered.

? + + -

21. The guideline presents monitoring and/or auditing criteria. ? + - -

Domain 6: Editorial Independence

22. The views of the funding body have not influenced the content of the guideline.

+ + ? ?

23. Competing interests of guideline development group members have been recorded and addressed.

? + + +

Item

Guideline

INESSS/ONF, 2016, 14

Fisher, 201315 Pang, 201316 NICE, 20138

Domain 1: Scope and Purpose

1. The overall objective(s) of the guideline is (are) specifically described.

+ + + +

2. The health question(s) covered by the guideline is (are) + - + +


Item

Guideline

Stroke Foundation,

201711



2016 7

Winstein (AHA/ASA),

201612


201513

specifically described.

3. The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described.

+ + + +

Domain 2: Stakeholder Involvement

4. The guideline development group includes individuals from all relevant professional groups.

+ + ? +

5. The views and preferences of the target population (patients, public, etc.) have been sought.

+ - - ?

6. The target users of the guideline are clearly defined. + + - +

Domain 3: Rigour of Development

7. Systematic methods were used to search for evidence. - - + +

8. The criteria for selecting the evidence are clearly described. - + + -

9. The strengths and limitations of the body of evidence are clearly described.

+ - + +

10. The methods for formulating the recommendations are clearly described.

+ + - +

11. The health benefits, side effects, and risks have been considered in formulating the recommendations.

+ - + -

12. There is an explicit link between the recommendations and the supporting evidence.

- - + +

13. The guideline has been externally reviewed by experts prior to its publication.

+ - + +

14. A procedure for updating the guideline is provided. + - - +

Domain 4: Clarity of Presentation

15. The recommendations are specific and unambiguous. + + + +

16. The different options for management of the condition or health issue are clearly presented.

+ - + +

17. Key recommendations are easily identifiable. + + + +


Item

Guideline

Stroke Foundation,

201711



2016 7

Winstein (AHA/ASA),

201612


201513

Domain 5: Applicability

18. The guideline describes facilitators and barriers to its application.

- - - -

19. The guideline provides advice and/or tools on how the recommendations can be put into practice.

+ - - +

20. The potential resource implications of applying the recommendations have been considered.

- + - -

21. The guideline presents monitoring and/or auditing criteria. + - - -

Domain 6: Editorial Independence

22. The views of the funding body have not influenced the content of the guideline.

? + ? ?

23. Competing interests of guideline development group members have been recorded and addressed.

+ + + ?

Institut National d’Excellence en Santé et en Service Social; NICE = National Institute for Health and Care Excellence; ONF = Ontario Neurotrauma Foundation;


Appendix 4: Main Study Findings and Authors’ Conclusions

Table 4: Summary of Recommendations in Included Guidelines

Recommendations Strength of Evidence and Recommendations

Stroke Foundation, 201711

“For stroke survivors, rehabilitation should be structured to provide as much scheduled therapy (occupational therapy and physiotherapy) as possible.” (section 10.1)

“For stroke survivors, group circuit class therapy should be used to increase scheduled therapy time.” (section 10.1)

“A minimum of three hours a day of scheduled therapy (occupational therapy and physiotherapy) is recommended, ensuring at least two hours of active task practice occurs during this time.” (section 10.1)

The recommendation to provide structured therapy was rated as strong while the recommendation on intensity was rated as weak.

Hebert, 2016 (Canadian Stroke Best Practice Recommendations)7

Two statements relevant to duration of stroke rehabilitation were included:

“Patients should receive a recommended three hours per day of direct task-specific therapy, five days a week, delivered by the interprofessional stroke team (Evidence Level C); more therapy results in better outcomes (Evidence Level A).”(p.467)

“Patients should receive rehabilitation therapies of appropriate intensity and duration, individually designed to meet their needs for optimal recovery and tolerance levels (Evidence Level A).”(p.467)

The level of evidence ranged from A to C as indicated. Although individuals who had experienced a stroke or their families were said to be part of the guideline group and/or external reviewers, it was not clear that their views and preferences were sought. In addition, while a systematic literature search was conducted and the level of evidence was based on the types of studies that were included, the criteria used to select the evidence were not described.

Winstein, 2016 (AHA/ASA)12

Three recommendations specific to duration of stroke rehabilitation were found:

Inpatient hospital rehabilitation at an intensity level commensurate with anticipated benefit and tolerance of the individual (class I, level B evidence).

To prevent skin breakdown and contractures, the guidelines suggest positioning of a hemiplegic shoulder in maximum external rotation while the patient is either sitting or in bed for 30 minutes daily is probably indicated (class IIa, level B evidence).

For post-stroke depression, an exercise program of at least four weeks duration may be considered as a complementary treatment (class IIb, level B evidence)

The evidence ranged from class I, level B to class IIb, level B. Although the authors systematically cited the literature that guided the recommendations, they did not provide details of the methodology used to formulate the recommendations

Paleg and Livingstone, 201513

“Dosage data suggests that use of a standing device should occur for 30 [minutes] 5 times a week for positive impact on most outcomes such as self-care and standing balance, ROM, cardio-respiratory, strength, spasticity, pain, skin and bladder and bowel function while 60 min 4–6 times a week may be required for positive impact on BMD and mental function.” (p.14)

Specific to stroke:

high quality evidence - 30 minutes of standing five times a

Specific to stroke and brain injury, the quality of evidence ranged from unclear to high. There were two authors involved in the development of the guidelines, their recommendations did not undergo peer review, and a process for revising the document was not outlined. The views and preferences of the target group were not sought nor where the target users described. The recommendations


Recommendations Strength of Evidence and Recommendations

week helped patients maintain ankle range of motion and general activity

low quality evidence - 20 to 30 minutes daily resulted in static standing orthostatic hypotension in 52% of a test population.

Specific to traumatic or acute brain injury:

evidence of unclear quality - 30 minutes a day of standing five days a week decreases or eliminated ankle contracture

Specific to traumatic or acute brain injury (potential harms)

low quality evidence - 30 minutes a day of static standing three days a week worsened orthostatic hypotension in 75% of patients with acute brain injury

very low quality evidence - 30 minutes of standing three to six times per week could be tolerated before patients with TBI started to experience increase in pain.

focused on standing and as such alternate management options were not considered. The guidelines did not meet any of the criteria for applicability.

INESSS/ONF, 201614

“To achieve optimal efficiencies of inpatient rehabilitation, individuals with traumatic brain injury should receive a minimum of 3 hours per day of therapeutic interventions, ensuring focus on cognitive tasks as recommended in [other sections of the guideline document].”(p.4)

“The target length of stay should be established based on individuals with similar functional status and availability of resources in the community, and take into account other factors such as the Glasgow Coma Score in the first few days after injury, intracranial surgery, the degree of initial disability, the presence of fractures of the upper and lower extremities or pelvis, and the person’s age.”(p.4)

The evidence that informed the guidelines were rated level C The authors did not describe the criteria that were used to select and extract information from the guidelines. The facilitators and barriers to implementing the recommendations were not indicated however the authors provided a number of tools and resources to support implementation. It is unclear whether the funding bodies (INESSS and ONF) influenced the content of the guideline given that the governance body that was responsible for overall guidance of the guideline development process included members from both organizations.

Fisher, 201315

“The intensity and length of intervention delivered by stroke specialist teams should be based on clinical needs tailored to goals and outcomes.” (p.747)

The evidence was based on 96% consensus.

Pang, 201316

“There is strong evidence that 20 to 40 minutes of aerobic exercise (40 to 50% heart rate reserave progressing to 60 to 80%) offered three to five days per week is beneficial for enhancing aerobic fitness, walking speed and walking endurance in people who have had mild to moderate stroke and are deemed to have low cardiovascular risk with exercise after proper screening assessments.” (p.1)

The level A recommendation indicates that the benefits of aerobic exercise clearly outweigh the risks.

NICE, 20138

“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.”(p.20)

A level of confidence was not assigned to the recommendation.

AHA/ASA = American Heart Association/American Stroke Association; Institut National d’Excellence en Santé et en Service Social; NICE = National Institute for Health

and Care Excellence; ONF = Ontario Neurotrauma Foundation; TBI = traumatic brain injury


Appendix 5: Additional References of Potential Interest

Consensus-based guidelines

The ESMO / European Sarcoma Network Working Group. Bone sarcomas: ESMO Clinical

Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012;23(Suppl

7):vii100-vii109. https://academic.oup.com/annonc/article/23/suppl_7/vii100/144789.

Accessed 2018 Nov 16.

Stacchiotti S, Sommer J. Building a global consensus approach to chordoma: a position paper from the medical and patient community. Lancet Oncol. 2015;16:e71-83. https://www.thelancet.com/action/showPdf?pii=S1470-2045%2814%2971190-8. Accessed 2018 Nov 16.

Guidelines missing a description of the development process

Laperriere N. Central nervous system: skull base tumours. Toronto (ON): Princess

Margaret Cancer Centre; 2018:

https://www.uhn.ca/PrincessMargaret/Health_Professionals/Programs_Departments/Docu

ments/CPG_CNS_SkullBaseTumours.pdf. Accessed 2018 Nov 16.
https://academic.oup.com/annonc/article/23/suppl_7/vii100/144789https://www.thelancet.com/action/showPdf?pii=S1470-2045%2814%2971190-8https://www.uhn.ca/PrincessMargaret/Health_Professionals/Programs_Departments/Documents/CPG_CNS_SkullBaseTumours.pdfhttps://www.uhn.ca/PrincessMargaret/Health_Professionals/Programs_Departments/Documents/CPG_CNS_SkullBaseTumours.pdf