CRITICALLY APPRAISED PAPER (CAP) FOCUSED QUESTION What are the observed effects on pain and fatigue when comparing two occupational therapy activity-pacing interventions in adults with osteoarthritis? Murphy, S. L., Lyden, A. K., Smith, D. M., Dong, Q., & Koliba, J. F. (2010). Effects of a tailored activity pacing intervention on pain and fatigue for adults with osteoarthritis. American Journal of Occupational Therapy, 64, 869 876. http://dx.doi.org/10.5014/ajot.2010.09198 CLINICAL BOTTOM LINE: Existing literature found that osteoarthritis (OA) is characterized as negatively effecting quality of life and reducing independence in mobility in adults with the disease. Current effective treatment of OA is cited as a combination of pain management medication and clinical care. A commonly used occupational therapy intervention to manage symptoms of OA involves education in the general principles of activity pacing. The authors considered a more individualized approach to activity pacing to provide a more personalized intervention and improve long-term behavior changes. This study examined the effectiveness of a tailored activity-pacing intervention when compared to a general activity-pacing intervention. The tailored intervention explored client s individualized needs and created an individualized plan to more effectively manage the symptoms of OA throughout a daily routine. The participant was able to discuss progress and barriers in implementing the activity-pacing program at follow-up sessions. The results, though not statistically significant, implied that participants in the tailor-fit intervention were less affected by fatigue in their daily life. Pain was not significantly changed in either. Implications for occupational therapy suggest that client-centered activity pacing that is more meaningful for the client may have a greater effect on an individual s fatigue resulting from OA than providing general activity-pacing education. Addressing a client s progress and identifying barriers with activity-pacing strategies is important to consider in implementing this intervention. The authors were able to establish preliminary support for the effectiveness of using tailor-fit interventions to address symptom management and engagement in daily activities for adults living with OA. With a larger sample size, it may be possible to confirm that fatigue is less severe for individuals implementing a tailored activity-pacing intervention into daily routines. Further research would allow expanding on this study s findings and identify opportunities to further increase the efficacy of occupational therapy s role in treating individuals with OA. Long-term behavior changes and long-term impact of a tailored activitypacing intervention on pain and fatigue should also be considered. 1
RESEARCH OBJECTIVE(S) List study objectives. 1. Determine whether implementing an individually tailored activity-pacing occupational therapy intervention would be more effective than traditional general activity pacing in adults with OA on reports of pain and fatigue. DESIGN TYPE AND LEVEL OF EVIDENCE: Randomized control trial (RCT): Level I 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. YES/NO As is congruent with an RCT and a basis on existing literature, this study sought to enhance understanding of and objectively quantify the extent to which adults with OA experience changes in level of daily activity as an effect of pain and fatigue. SAMPLE SELECTION How were subjects selected to participate? Please describe. Prospective participants in Southeastern Michigan responded to a public advertisement and underwent an initial telephone screening to determine eligibility. In addition, prospective participants signed consent forms and received X-rays at the University of Michigan to determine the level of severity and existence of OA. Inclusion Criteria Individuals ages 50 to 80 years old, fluent in English, and having received a score of > 26 on the Mini-Mental Status Exam (MMSE). Individuals experiencing active, symptomatic OA in either a hip or knee joint, with at least one joint being affected. The individual must have experienced pain in the affected joint for a minimum of 3 months and received a score of > 4 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Pain must have reached a level of severity in which the individual reported moderate pain or more than 2 items on the WOMAC s Pain subscale. Individuals whose OA could be identified through radiographic testing and a score of > 2 on the Kellgren Lawrence Scale. Individuals able to operate an accelerometer to record data for the study. Individuals able to follow occupational therapy recommendations. Exclusion Criteria Individuals outside of the 50-to-80 year age range, nonenglish speaking, and having received a score of < 26 on the MMSE. Individuals who are nonambulatory and have medical conditions other than OA that affects their amount of daily activity and level of pain and fatigue. Individuals having a surgical procedure to the knee or hip within the last 6 months. 2
Individuals receiving current treatment for OA other than pharmacological treatment. Individuals unable to operate accelerometer. Individuals unable to follow occupational therapy recommendations. SAMPLE CHARACTERISTICS N = 42 % Dropouts 24% n = 10* #/ (%) Male 8/ 25% #/ (%) Female 24/ 75% Ethnicity White: n = 25 78% African American: n = 6; 19% Pacific Islander: n = 1; 3% Disease/disability diagnosis OA (hip or knee) *Note that during this study, 6/10 participants withdrew from the general intervention, 2/10 participants withdrew from the tailored intervention, and 2/10 participants served as the pilot participants and were therefore not included for data analyses within the tailored intervention. These numbers comprise the total dropouts (n = 10/ 24%) from the study. 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: General intervention Brief Description At a baseline meeting, individual participant data was collected, including demographic information, health status, and physical performance tests. In addition, all participants received detailed instructions on use of an accelerometer and log book for activity recording during an initial 5-day home-monitoring program. During the home program, each participant wore the accelerometer on the nondominant wrist, and symptoms and activity pacing behaviors were manually entered into the device 6 times throughout the day (wake-up time; 2, 4, 8, and 12 hr after waking; 30 min prior to bed time). The log book served as a written format of symptoms and activity-pacing behaviors. After completion of the home program, all accelerometers and log books were returned. Participants then met with an occupational therapist (OT) for 2 one-onone sessions within a 2-week period. During the initial meeting, 3
participants received recommendations on activity pacing to be carried out for the remainder of the study. Participants met with an OT for a second time to discuss the effectiveness of implementing the recommendations and any existing barriers. At a 10-week follow-up and posttest, participants completed a second 5- day home-monitoring program and completed questionnaires. The 10- week follow-up included additional physical performance tests. Setting The setting of the initial baseline testing, occupational therapy sessions, and 10-week follow-up and lab tests was not reported. The setting in which the 5-day home-monitoring program occurred was implied to be the participants homes. Who Delivered? 2 occupational therapists, 1 in each, delivered interventions to the general intervention and tailored intervention. Frequency? 2 occupational therapy sessions. Duration? 2-week period of intervention. Group 2: Tailored intervention Brief Description At a baseline meeting, individual participant data was collected, including demographic information, health status, and physical performance tests. In addition, all participants received detailed instructions on use of an accelerometer and log book for activity recording during an initial 5-day home-monitoring program. During the home program, each participant wore the accelerometer on the nondominant wrist and symptoms and activity pacing behaviors were manually entered into the device 6 times throughout the day (wake-up time; 2, 4, 8, and 12 hr after waking; 30 min prior to bed time). The log book served as a written format of symptoms and activity pacing behaviors. After completion of the home program, all accelerometers and log books were returned. Participants then met with an OT for 2 one-on-one sessions within a 2- week period. During the initial meeting, participants received detailed and personalized recommendations on activity pacing to be carried out for the remainder of the study on the basis of results from their 5-day home-monitoring program. Participants met with an OT for a second time to discuss the effectiveness of implementing the recommendations and any existing barriers. At a 10-week follow-up and posttest, participants completed a second 5- day home-monitoring program and completed questionnaires. The 10- week follow-up included additional physical performance tests. Setting The setting of the initial baseline testing, occupational therapy sessions, and 10-week follow-up and lab tests was not reported. The setting in which the 5-day home-monitoring program occurred was implied to be the participants homes. Who Delivered? 2 occupational therapists, 1 in each, delivered interventions to the general intervention and tailored intervention. 4
Frequency? 2 occupational therapy sessions. Duration? 2-week period of intervention. Intervention Biases: Circle yes or no and explain, if needed. Contamination YES/NO No. Organized randomization of participants into either a tailored intervention (treatment ) or general intervention (control ) served to limit contamination bias. Co-intervention YES/NO No. If a participant was receiving supplementary OA treatment (other than pharmacological agents), they were excluded from the study. This exclusion criterion limited the effects of other interventions on this study. Timing YES/NO No. Data collection periods occurred at different time intervals (baseline, 10 weeks), which increased the likelihood that the observed effects were from the intervention received and not from natural maturation causes. Site YES/NO NR. Reasonable conclusions about contamination bias on the basis of onsite location are unable to be made, because this study does not clearly identify where the assessments or interventions took place. In addition, the study implied that the intervention was educated initially then advised to do the tailored activity pacing independently, without any guidance or followups; the researchers appeared to rely heavily on the participants motivation and compliance, which may introduce unforeseen bias to the results. Use of different therapists to provide intervention YES/NO Yes. The authors of this study discuss that because of the small sample size, there was no plausible means of control for style of intervention delivery from the occupational therapists and this may have introduced bias. Natural differences in therapeutic use of self between the therapists may have inadvertently affected the results. The occupational therapists were blinded to the study s hypotheses and were not involved in data collection or analysis of results to control for biasing effects of intervention delivery. NR = not reported 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/nr [not reported]), and how frequently the measure was used. WOMAC was used as a tool to objectively measure pain. It consists of a disease-specific questionnaire and a 20-point Pain subscale in which a higher rating indicates more pain. Reliable: NR Valid: Yes 5
Frequency: Measured at baseline, immediately following intervention (approximately 4 weeks after baseline; this data was not used in analysis of results) and at 10-week follow-up. Name of measure, what outcome was measured, whether the measure is reliable and valid (as reported in article yes/no/nr [not reported]), and how frequently the measure was used. Brief Fatigue Inventory (BFI) is a 10-item scale designed to measure fatigue. The study chose to use two fatigue subscales of the BFI, Fatigue Severity and Fatigue Interference, to construct a more comprehensive analysis of the relationship between fatigue and its effect on daily activity. Reliable: NR Valid: Yes Frequency: Measured at baseline, immediately following intervention (approximately 4 weeks after baseline; this data was not used in analysis of results), and at 10-week follow-up. Measurement Biases Were the evaluators blind to treatment status? Circle yes or no, and if no, explain. YES/NO Yes. The assessors who carried out the testing and participant measurements were blind to participants randomized allocation to s and were unaware of the treatment status of each participant. The two treating occupational therapists were aware of each participant s intervention status, either general or tailored intervention, however, they were blinded to the study s hypotheses and were unaware of the collection of data or analysis of results. Recall or memory bias. Circle yes or no, and if yes, explain. YES/NO No. The measures used to answer the main study objective were administered at a baseline and 10-week follow-up. Without use of self-report from participants, this component of the study controlled for potential recall or memory bias. Although participants were instructed to self-report activity levels throughout the day by use of an accelerometer, a balanced representation of activity levels and symptoms was established. In addition, the information gathered from the accelerometer, (physical activity), was not used as a measure for answering the main study objective. Others (list and explain): N/A 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 general intervention and tailored intervention s were similarly matched as identified through preliminary statistical analysis; no statistically significant differences were found on the following characteristics: medication regimens, physical activity, physical function, fatigue severity and interference with daily 6
activities, and pain. This ensured homogeneity between s and limited the chance for differences to inadvertently affect results. In consideration of the small sample size, the researchers chose to incorporate effect size as a secondary component of documenting potential significant results. A small effect size was defined as d = 0.2, moderate effect size as d = 0.5, and a large effect size as d = 0.8. The study noted that a small effect size was noted for pain (d =.38), a moderate-to-large effect size was obtained for fatigue severity (d =.79), and a large effect size was found for fatigue interference (d = 1.10). This suggests that although the results were not statistically significant for differences on pain (p =.09), there appeared to be a trend toward decreased levels of pain in the tailored intervention. In addition, for fatigue severity and interference, the large effect sizes imply that individuals who implemented tailored activity pacing strategies had experienced less fatigue at the 10-week follow-up. A repeated-measures ANOVA was completed to compare mean differences between the variables of pain and fatigue. WOMAC Pain measure indicated decreased pain at the 10-week follow-up for both s, although results were not statistically significant (p =.35), with a small effect size (d =.38). Although the BFI Fatigue Severity subscale scores revealed no statistically significant differences between s, the tailored intervention appeared to trend toward significance (p =.09), indicating a larger decrease in fatigue severity over the course of intervention compared to the general intervention. In addition, a moderate-to-large effect size was indicated for this difference (d =.79). BFI Fatigue Interference subscale scores indicated statistically significant results for the tailored intervention (p =.02), with a large effect size (d = 1.10), indicating a larger decrease in interference with daily activities compared to the general intervention. Time between baseline and 10-week follow-up was explored as an interaction effect and no statistically significant results were found. Was this study adequately powered (large enough to show a difference)? Circle yes or no, and if no, explain. YES/NO No. The authors cited small sample size as a probable indicator of why the study s results lacked statistical significance. They further noted that with a larger sample size, this study s statistical significance and, by association, its the power may have increased. Were appropriate analytic methods used? Circle yes or no, and if no, explain. YES/NO Yes. Independent sample t-tests were used to identify baseline differences between the two s to control for potential bias. For the main results of the study, the researchers used a general linear model in an attempt to identify existence of a positive relationship between dependent variables of pain and fatigue on daily activity level. The use of a repeated-measures ANOVA, a statistical test component of a general linear model, allowed the 7
researchers to examine the differences between the s at pretest and posttest. Were statistics appropriately reported (in written or table format)? Circle yes or no, and if no, explain. YES/NO Yes. Group differences were presented in narrative and table format. General linear models examining the relationship between the dependent variables and independent variable were presented in narrative and table format. CONCLUSIONS State the authors conclusions that are applicable to answering the evidence-based question. The results of this study suggest that when individualized activity pacing is implemented as an occupational therapy intervention for adults with OA, there is potential for more effective management of symptoms (particularly fatigue) and levels of daily activity. An individualized activity-pacing intervention allowed participants to have more sustained periods of activity throughout their day and with less frequent rest periods, suggesting enhanced engagement in activity through more effective symptom management. Small sample size limited the ability to make strong conclusions pertaining to the differences between the two s, but statistically significant results indicated that the tailored intervention experienced less fatigue interference and showed a trend toward decreased fatigue with daily activities. The authors suggested completing a larger, more in-depth study could further expand their results in determining effectiveness of tailor-fit activity-pacing occupational therapy interventions in treating adults with OA. This work is based on the evidence-based literature review completed by Kelly Erickson PhD, OTR/L (Assistant Professor, The College of Saint Scholatica), and Stephanie Helland, OTS (Occupational Therapy Student, The College of Saint Scholastica). 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 8