CRITICALLY APPRAISED PAPER (CAP) FOCUSED QUESTION What is the effectiveness of community-based occupational therapy in enhancing participation in valued activities for people 6 months post-stroke in comparison to those who did not receive occupational therapy? Eagan, M., Kessler, D., Laport, L., Metcalfe, V., & Carter, M. (2007). A pilot randomized controlled trial of community-based occupational therapy in late stroke rehabilitation. Topics in Stroke Rehabilitation, 14(5), 37 45. http://dx.doi.org/10.1310/tsr1405-37 CLINICAL BOTTOM LINE: Because details of the intervention program such as the amount of time between treatment sessions, the time spent per session, the location of the treatment, and the structure of sessions were not reported, the intervention program cannot be effectively replicated. Therefore, program directors and intervention specialists cannot draw sufficient information from this article to develop a program. In addition, the primary outcomes show a discrepancy between participants changes in performance and changes in satisfaction with performance following intervention. There was a statistically significant difference between the control and intervention s in regard to satisfaction with performance, but there was no statistically significant difference in regard to performance in valued activities, participation, and wellbeing. The differences between s may have been due to a placebo effect or difficulties with outcome measures of the used for the study. The results of this study do not provide adequate results to support community-based occupational therapy 6 months post-discharge, but the study does indicate the need for further research and different outcome measures. RESEARCH OBJECTIVE(S) List study objectives. Demonstrate potential effectiveness of an occupational therapy intervention to enhance participation in personally valued activities among individuals 6 months post-stroke. To determine the appropriateness of the measurement tools for a larger, more definitive trial. 1
DESIGN TYPE AND LEVEL OF EVIDENCE: Level I Randomized control trial Limitations (appropriateness of study design): Was the study design type appropriate for the knowledge level about this topic? Circle yes or no, and if no, explain. SAMPLE SELECTION How were subjects selected to participate? Please describe. All participants were individuals who had experienced embolic strokes and received in-patient rehabilitation at the Elisabeth Bruyere Health Center. A total of 27 participants were contacted from a pool of the 31 eligible people, and 16 agreed to enroll in the study. The recruitment process was not described in the article, and participants were randomized by someone not associated with the study. Inclusion Criteria Participants must have received inpatient rehabilitation at the Elisabeth Bruyere Health Center due to a stroke. The participants must have been able to speak either English or French and had been discharged at least 6 months prior to beginning the study. Study participants had to also have adequate cognitive skills. To be deemed cognitively adequate, they must have achieved a FIM TM score of at least 4 for expressive communication and 5 for receptive communication, as well as a Mini-Mental State Examination score of at least 23. Exclusion Criteria Poor prognosis for 12-month survival due to serious comorbidity and residence outside of the regional municipality of Ottawa Carleton. SAMPLE CHARACTERISTICS N = 16 % Dropouts 12.5% #/ (%) Male Control: 6/75% Intervention: 5/83% #/ (%) Female Control: 2/25% Intervention: 1/17% Ethnicity Disease/disability diagnosis Embolic stroke 2
Check appropriate : <20/study 20 50/study 51 100/study 101 149/study 150 200/study INTERVENTION(S) AND CONTROL GROUPS Add s if necessary. Group 1 Brief Description Intervention Group: The 6 patients in the intervention received up to 8 visits from an occupational therapist to work on issues specifically related to participation in valued activities. The occupational therapist designed a plan guided by the Canadian Occupational Performance Measure (COPM) and the Occupational Performance Process Model to address issues in meaningful daily activities by examining barriers and facilitators to participation. The occupational therapist s treatment methods included coaching, education, changes to the physical environment, and use of resources with the goal of enabling the client to achieve his or her goals. Setting Who Delivered? Frequency? Duration? Group 2 Community settings (not described). Occupational therapist. Up to 8 visits ( amount of time between visits). 2 4 months. Brief Description Control : The 8 participants in the control received usual poststroke care, which did not involve occupational therapy. Setting Who Delivered? Frequency? Duration? Group 3 Brief Description Setting Who Delivered? Frequency? Duration? Intervention Biases: Circle yes or no and explain, if needed. Contamination 3
Co-intervention Timing Site Use of different therapists to provide intervention MEASURES AND OUTCOMES Complete for each relevant measure when answering the evidence-based question: Name of measure, what outcome was measured, whether the measure is reliable and valid (as reported in article yes/no/ [not reported]), and how frequently the measure was used. COPM: Performance and satisfaction in regard to valued daily activities; reliable and valid; once prior to treatment, once 3 months after treatment. Name of measure, what outcome was measured, whether the measure is reliable and valid (as reported in article yes/no/ [not reported]), and how frequently the measure was used. Short Form 36 (SF 36): Well-being; valid and reliable; once prior to treatment, once 3 months after treatment. Name of measure, what outcome was measured, whether the measure is reliable and valid (as reported in article yes/no/ [not reported]), and how frequently the measure was used. Reintegration to Normal Living Index: Participation; valid and reliable; once prior to treatment, once 3 months after treatment. Measurement Biases Were the evaluators blind to treatment status? Circle yes or no, and if no, explain. The study was originally designed to be blind. However, following each posttest, the evaluator guessed which she believed the patient was in and correctly identified 12 of the 14 participants. Recall or memory bias. Circle yes or no, and if yes, explain. 4
Others (list and explain): RESULTS List results of outcomes relevant to answering the focused question. Include statistical significance where appropriate (p < 0.05). Include effect size, if reported. The hypothesis that the intervention could enhance participation in stroke survivors was partially confirmed. The intervention and control participants did not vary on perceived changes to performance, but there was a clinically and statistically significant difference in satisfaction with performance among intervention patients. The discrepancy between perceived changes in performance and changes in satisfaction with performance may reflect the tendency of participants to rate their current performance relative to prestroke performance, whereas satisfaction with performance may be associated with improved self-efficiency in current performance. There were no differences in secondary measures. The effect size in performance change was.011, whereas the effect size in satisfaction change was 1.31. All results were a 95% confidence level, p <.05. Was this study adequately powered (large enough to show a difference)? Circle yes or no, and if no, explain. There were only 6 intervention candidates and only 8 control candidates; thus, there is not a sufficient number of participants to produce significant statistical evidence. Were appropriate analytic methods used? Circle yes or no, and if no, explain. Were statistics appropriately reported (in written or table format)? Circle yes or no, and if no, explain. CONCLUSIONS State the authors conclusions that are applicable to answering the evidence-based question. The author claims that the study does have potential to show the effectiveness of the intervention. The results showed no statistically significant difference in regard to performance, well-being, or participation. However, there was a statistically significant difference in regard to satisfaction with performance. Study limitations include the small sample size, possible placebo effect of treatment, and the use of unsuitable measurement tools. The COPM and SF 36 were not appropriate measures for the effectiveness of community-based occupational 5
therapy. The COPM was problematic in that it was incapable of measuring revised, more meaningful goals that were not a part of the initial COPM score. Further studies should seek other measurement tools. This work is based on the evidence-based literature review completed by Katherine Buckley, OTS, and Rebecca Aldrich, PhD, OTR/L, Faculty Advisor, St. Louis University. CAP Worksheet adapted from Critical Review Form Quantitative Studies, copyright 1998, by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, & M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 6