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BMJ 2007;335:922 (3 November), doi:10.1136/bmj.39343.466863.55 (published 27 September 2007)
Lynn Legg, CSO research training fellow1, Avril Drummond, principal research fellow in rehabilitation3, Jo Leonardi-Bee, lecturer in medical statistics2, J R F Gladman, professor of medicine of older people3, Susan Corr, reader in occupational science4, Mireille Donkervoort, senior researcher department of rehabilitation medicine5, Judi Edmans, research occupational therapist3, Louise Gilbertson, clinical specialist occupational therapist in stroke6, Lyn Jongbloed, associate professor7, Pip Logan, principal research fellow3, Catherine Sackley, professor of physiotherapy research8, Marion Walker, associate professor and reader in stroke rehabilitation and associate director UK stroke research network3, Peter Langhorne, professor of stroke care1
1 Academic Section of Geriatric Medicine, Glasgow Royal Infirmary University NHS Trust, Glasgow G31 2ER, 2 Division of Epidemiology and Public Health, Clinical Sciences Building, City Hospital Campus NHS Trust, Nottingham NG5 1PB, 3 Division of Rehabilitation and Ageing, Medical School, Queen's Medical Centre, Nottingham, 4 Division of Occupational Therapy, School of Health, University of Northampton, Northampton NN2 7AL, 5 Erasmus University Medical Centre, Postbus 2040, 3000 CA, Rotterdam, Netherlands, 6 Occupational Therapy Service, Royal Haslar Hospital, Gosport PO12 2AA, 7 Department of Occupational Science And Occupational Therapy, UBC School of Rehabilitation Sciences, Online Programs, University of British Columbia, T325-2211 Wesbrook Mall, Vancouver, BC, Canada V6T 2B5, 8 Primary Care and General Practice, University of Birmingham, Edgbaston, Birmingham B15 2TT
Correspondence to: L Legg step{at}clinmed.gla.ac.uk
Design Systematic review and meta-analysis.
Data sources The Cochrane stroke group trials register, the Cochrane central register of controlled trials, Medline, Embase, CINAHL, PsycLIT, AMED, Wilson Social Sciences Abstracts, Science Citation Index, Social Science Citation, Arts and Humanities Citation Index, Dissertations Abstracts register, Occupational Therapy Research Index, scanning reference lists, personal communication with authors, and hand searching.
Review methods Trials were included if they evaluated the effect of occupational therapy focused on practice of personal activities of daily living or where performance in such activities was the target of the occupational therapy intervention in a stroke population. Original data were sought from trialists. Two reviewers independently reviewed each trial for methodological quality. Disagreements were resolved by consensus.
Results Nine randomised controlled trials including 1258 participants met the inclusion criteria. Occupational therapy delivered to patients after stroke and targeted towards personal activities of daily living increased performance scores (standardised mean difference 0.18, 95% confidence interval 0.04 to 0.32, P=0.01) and reduced the risk of poor outcome (death, deterioration or dependency in personal activities of daily living) (odds ratio 0.67, 95% confidence interval 0.51 to 0.87, P=0.003). For every 100 people who received occupational therapy focused on personal activities of daily living, 11 (95% confidence interval 7 to 30) would be spared a poor outcome.
Conclusions Occupational therapy focused on improving personal activities of daily living after stroke can improve performance and reduce the risk of deterioration in these abilities. Focused occupational therapy should be available to everyone who has had a stroke.
Personal activities of daily living are necessary for survival and include "those tasks which all of us undertake every day of our lives in order to maintain our level of care"3 such as feeding, dressing, toileting, grooming, transferring, and mobilising.4
Occupational therapy is an essential element in the rehabilitation of patients after stroke.5 It entails "use of purposeful activity or interventions designed to achieve functional outcomes which promote health, prevent injury or disability, and which develop, improve, sustain or restore the highest possible level of independence."6 Personal activities of daily living is major component of treatment for people who have had a stroke.7 Level of dependence in such activities is an important measure of the success of stroke rehabilitation8 and a commonly used outcome in stroke trials.4
A systematic review of therapy based rehabilitation services delivered to stroke patients living at home within one year of stroke onset9 found that those who received rehabilitation based on therapy were more independent in personal activities of daily living and more likely to maintain that ability during the study period. This review, however, covered a heterogeneous group of interventions (physiotherapy, occupational therapy, or multidisciplinary staff working with patients primarily to improve task orientated behaviour) and concluded that the "different groups of interventions might differ in their effects."
A subsequent analysis of data from individual patients from eight stroke trials focused on the effect of community occupational therapy on instrumental activities of daily living (including making a meal, using public transport, or using the telephone) and found benefits in personal activities of daily living (a secondary outcome) at the end of treatment but not at the end of scheduled follow-up.10 We are aware of more trials than were included in this review and in addition, occupational therapy is often given in settings other than the community, and its prime target is often to improve personal activities of daily living.
We conducted a systematic review to test the hypothesis that occupational therapy aimed at encouraging people to participate in personal activities of daily living after stroke will improve the recovery of ability to perform such activities.
Search strategy for the identification of studies
We followed the search strategy developed for the stroke group of the Cochrane collaboration.11 This comprised a search of the Cochrane stroke group trials register (last searched by the review group coordinator on 7 November 2006), the Cochrane central register of controlled trials (Cochrane Library, issue 4, 2007), electronic bibliographic databases including Medline, Embase, CINAHL, PsycLIT, AMED, Wilson Social Sciences Abstracts, and the following Web of Science databases: Science Citation Index (1945 to March 2007), Social Science Citation Index (1956 to March 2007), Arts and Humanities Citation Index, dissertation abstracts register, and the occupational therapy research index. Other strategies to ensure identification of all potentially relevant trials included scanning reference lists of relevant articles and original papers, personal communication with authors, and hand searching journals. For full details of all journals searched, with dates, please see the full review in the Cochrane Library.12 One reviewer read the titles of all the references identified and eliminated any obviously irrelevant studies—for example, pharmacological or surgical interventions and study designs other than randomised controlled trials. The abstracts of the remaining studies were obtained and selected according to the assessment of two reviewers. Differences in opinion regarding trial eligibility were resolved by consensus.
Data extraction
Two reviewers independently rated the methodological quality of studies using recognised criteria13: method of randomisation, allocation concealment, blinding of outcome assessment, and use of an intention to treat analysis. We aimed to obtain standardised data through collaboration with the original trialists. Two independent reviewers extracted data using a standard data recording form.
Data analysis
We performed an intention to treat analysis to reduce potential biases (follow-up, publication, and reporting) associated with extracting data from published reports. We obtained original trial data for eightw17w18w20-w25 of the nine studies. This enabled a uniform approach to re-analysis of the data and standardisation of outcomes.
Eight studies used individuals as the unit of randomisation and analysisw17-w23w25; one study used a randomised cluster trial design where the unit of randomisation was the nursing home.w24 The data from the cluster randomised trial were analysed for the number of events (participants worse or dead) at the individual level using data for each participant in each cluster. We used an intracluster correlation coefficient of 0.02 to calculate the design effect and effective sample size.14
Review Manager 4.27 was used for the statistical analysis.15 Binary outcomes were analysed with a fixed effect model, as Peto odds ratios with 95% confidence intervals. For continuous outcomes, we used the standardised mean difference with a random effects model to take account of statistical heterogeneity. Statistical heterogeneity between studies was examined with
2 and I2.16 An I2 value over 50% was considered to indicate substantial inconsistency. Publication bias was assessed with a rank correlation test and a funnel plot.17
We planned sensitivity analyses to explore the influence of the method of randomisation, allocation concealment, blinding of final outcome assessment, and the presence of an intention to treat analysis.
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Most studies had parallel groups with occupational therapy focused on personal activities of daily living compared with usual care or no routine intervention. Two trials compared two alternative interventions (occupational therapy based on leisure activities or personal activities of daily living) against usual care or no routine intervention in three parallel groups. One trial used a crossover design in which participants were given dressing practice followed by the personal activities of daily living intervention of interest, in sequence.w21 For further details of the interventions provided, see the Cochrane review.12
Eight trials clearly described concealed allocation, randomisation procedures, an objective, and explicit blinded outcome assessment for all participants.w17w18w20-w25 Four studies explicitly reported the use of an intention to treat analysis.w18w22w24w25 Median time to follow-up was six months (range 3-12 months). Rates of loss to follow-up varied considerably across the reported outcomes. Sixty one (8.5%) participants from the intervention groups and 34 (6.3%) from the control groups died during follow-up.
Personal activities of daily living
Six studies used the Barthel index18 to measure personal activities of daily living,w17w18w22-w25 one study used the self care section of the Rivermead personal activities of daily living scale,19w21 and one study used the functional independence measure.20w19 A score for personal activities of daily living was available for 961 (80.6%) participants from eight trials.w17-w19w21-w25 The pooled result for all trials, combined as a standardised mean difference, was 0.18 (95% confidence interval 0.04 to 0.32; P=0.01) with no significant heterogeneity (P=0.33) (fig 2).
Therefore, participants who received occupational therapy after stroke were significantly more independent in personal activities of daily living than those who received no intervention or usual care. The estimated standardised mean difference of 0.18 is equivalent to a one point (5%) difference on the 20 point Barthel index, assuming a population SD of six points.
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In our post hoc analysis excluding the leisure based occupational therapy arms from the two trialsw20w25 that compared alternative forms of intervention (occupational therapy based on leisure activities or personal activities of daily living), we found similar results (0.20, 0.06 to 0.33; P=0.004) with no significant heterogeneity (P=0.56).
Deterioration in personal activities of daily living
The second outcome concerned the extent to which occupational therapy could influence the risk of deterioration in personal activities of daily living. We defined this as the combined "poor outcome" of death or experiencing a deterioration in ability to perform personal activities of daily living (experiencing a drop of one or more points in a given score for personal activities of daily living) or dependent (below a predefined threshold on a given personal activities of daily living scale; for the Barthel index this was 15), or requiring institutional care at the end of scheduled follow-up. Data on poor outcome were available for 1065 (90.6%) participants from seven trialsw17w18w20w22-w25 and showed that the odds of a poor outcome were significantly lower in the participants who received occupational therapy (odds ratio 0.67, 0.51 to 0.87; P=0.003) with no significant heterogeneity between studies (P=0.28) (fig 3).
The overall rate of a poor outcome for controls was 42%, which combined with an odds ratio of 0.67 gives an estimated number needed to treat of 11 (7 to 30).
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There was no substantial change in results when we conducted sensitivity analyses excluding trials with clear intention to treat analysis. If we assume that the participants who were missing (66/673 (9.8%) in intervention groups and 44/502 (8.8%) in control groups) had a poor outcome, then the odds of a poor outcome remained significantly reduced for those participants who received occupational therapy (odds ratio 0.67, 0.52 to 0.86; P=0.002) with no significant heterogeneity (P=0.27). Furthermore, if we assume that the participants who were missing from the treatment groups were alive and well and living at home, then the odds of a poor outcome were still significantly reduced for those who received occupational therapy (odds ratio 0.71, 0.55 to 0.92; P=0.009) with no significant heterogeneity (P=0.20).
We found no evidence of publication bias from the rank correlation test for the outcome death or "poor outcome" (P=0.108, seven studies) or in the funnel plot.
Secondary outcomes
We had scores on the Nottingham extended activities of daily living scale for 847 (78.8%) participants from six trials.w17w18w20w22w23 Those who received occupational therapy were significantly more independent in instrumental activities of daily living (standardised mean difference 0.21, 0.03 to 0.39; P=0.02). There was a non-significant benefit in mood or distress scores for participants and carers. Data on use of institutional care, participants' and carers' quality of life, and satisfaction with services were incomplete and available for only a few studies and therefore the results from pooled analysis were inconclusive.
Limitations of the study
It is difficult to design and conduct high quality clinical trials of rehabilitation. Firstly, the masking of therapies from patient and therapist is difficult, thus permitting the introduction of bias, particularly when the person providing the intervention is also the person doing the research, as is the case with many of the studies in this review. Secondly, while usual or standard care is recognised as an appropriate control, this may include interventions that promote activities, which potentially reduces the estimate of the intervention effect.21 Thirdly, it is more difficult to obtain acceptance of randomisation in an inpatient setting, particularly where an occupational therapy service is already established. We excluded four trials that compared one occupational therapy intervention within an active concurrent control arm provided in inpatient settings as they did not provide an unconfounded estimate of effect.w1-w4 Finally, trials of rehabilitation interventions typically have lengthy follow-up periods with a risk of study dropout. This makes performing a true intention to treat analysis with complex scores such as the Barthel index problematic as it is difficult to score for missing participants. Despite these potential concerns, however, the quality of the included trials was generally good and the results were consistent between trials.
Occupational therapy is a complex intervention. Practice includes skilled observation; the use of standardised and non-standardised assessments of the biological, psychiatric, social, and environmental determinants of health; clarification of the problem; formulation of individualised treatment goals; and the delivery of a set of individualised problem solving interventions. While we are confident that all the interventions in this review were consistent with this broad concept of occupational therapy, we recognise that the exact nature of the interventions in each study differed according to the type of patient, the expertise of the therapist, and the resources available. The interventions tested were probably provided by experts and not particularly constrained by day to day service factors. Our review did not compare occupational therapy with alternative rehabilitation interventions, nor did it examine the effect of occupational therapy combined with other interventions.
Comparison with previous studies
Previous reviews that have assessed the role of occupational therapy either have not specifically focused on stroke,22 have concentrated on instrumental activities of daily living in the subgroup of stroke patients living in the community,10 or have included a wide range of studies of varying methodological quality.23 Our review adds substantially to the literature by examining the effects of occupational therapy focused personal activities of daily living in stroke patients regardless of treatment setting.
Implications for research
Occupational therapy after stroke "works" in that it improves outcome in terms of ability in personal activities of daily living. The estimate that 11 (7 to 30) patients need to be treated to avoid one patient deteriorating in personal activities of daily living should be regarded as an approximate indicator. This is a relatively crude measure of outcome, which does not capture potential benefits in other domains of health. This figure also suggests, however, that not all patients treated by an occupational therapist will benefit. Further work is required to define those individuals who are most likely to benefit from occupational therapy, and economic studies are required to examine the cost effectiveness of occupational therapy. We believe that our findings should move the research agenda away from the questions surrounding whether occupational therapy (as a package of interventions) is effective to the identification of which specific interventions are effective for particular patients.
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Contributors: LL and AD planned the review. LL was lead reviewer and produced the first draft of the paper. AD, PLa, JL-B, and JRFG all collaborated on the final version before initial submission and took responsibility for the submitted version of the paper. SC, MD, JE, LG, LJ, PLo, CS, and MW were members of the occupational therapy trialists and obtained primary data and assisted in the editing of the paper. LL is guarantor.
Funding: The Big Lottery Fund and Chest Heart and Stroke Scotland funded staff time.
Competing interests: None declared.
Ethical approval: Not required.
Provenance and peer review: Not commissioned; externally peer reviewed.
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