CRITICALLY APPRAISED PAPER (CAP)

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1 CRITICALLY APPRAISED PAPER (CAP) Logan, D. E., Carpino, E. A., Chiang, G., Condon, M., Firn, E., Gaughan, V. J.,... Berde, C. B. (2012). A day-hospital approach to treatment of pediatric complex regional pain syndrome: Initial functional outcomes. Clinical Journal of Pain, 28(9), CLINICAL BOTTOM LINE The clinical importance of this study s results is that the intensive day-hospital pain rehabilitation program seems favorable, which brings a different approach into the field of occupational therapy for the treatment of children with complex regional pain syndrome (CRPS). This study shows that after participation in the interdisciplinary program (composed of occupational, physical, and cognitive behavioral therapies), patients demonstrated reductions at discharge in perceived pain intensity and functional disability, increased limb function, and improvements in occupational performance and satisfaction. Patients participated in the interdisciplinary program for 8 hours/day, 5 days/week, for an average stay of 3 weeks. At follow-up, about 2 24 months after discharge, patients continued to report improved function. This innovative multidisciplinary approach could potentially decrease medical costs. Additionally, an intensive day program that is client centered and family centered seems to help decrease the patients pain and increase function. Thus, this approach to treatment promotes an overall increase in quality of life for both the patient and the patient s family members. As occupational therapy practitioners look at increasing clients occupational performance, the evidence disseminated in this study can be viewed as positive. With the growing prevalence of pediatric CRPS, it is imperative to further investigate the promising results of this study to promote the most effective and cost-efficient treatment of this population. RESEARCH OBJECTIVE(S) To examine clinical outcomes of an interdisciplinary day hospital treatment program (comprised of physical, occupational, and cognitive-behavioral therapies with medical and nursing services) for pediatric complex regional pain syndrome (p. 766) DESIGN TYPE AND LEVEL OF EVIDENCE: 1

2 Level IV: Longitudinal case series SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. Children with CRPS were referred to the day-hospital program and, consequently, for the study by health care providers in the researchers larger chronic pain service, outside medical specialists, or families. The researchers used a nonprobability method of sampling to select participants for the study, because there were specific inclusion and exclusion criteria, followed by a standard evaluation process to further assess eligibility. Thus, the researchers screened potential participants, determined eligibility, and then recruited appropriate participants. INCLUSION CRITERIA Participants were included in the study if they were between the ages of 8 and 18 years and met the International Association for the Study of Pain clinical criteria for CRPS with motor impairments. Because these criteria were developed for adult CRPS, participants had to fulfill the primary criterion of pain, which is pain with neuropathic features and disproportionate to any inciting event. In addition, the pain also could not be explained by any underlying disease process but must lead to significant impairment of mobility and limb use. Furthermore, as stated by the third-party payers, to qualify for the day-hospital program, participants had to have demonstrated failure to progress in conventional outpatient physical therapy, which was three times per week, and cognitive behavioral therapy for 6 8 weeks. EXCLUSION CRITERIA Although psychological challenges are largely part of CRPS, participants were excluded from the study if they were experiencing active suicidality or need for inpatient psychiatric care. For example, the researchers excluded participants with severe active eating disorder presentation or vegetative depressive symptoms that prevented engagement in functional rehabilitation activities. Furthermore, because clinicians in the outpatient pain treatment clinic completed a checklist of CRPS symptoms for any eligible participants, those who did not meet said CRPS symptoms were not included in this study. SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 56 #/ (%) Male 6/(10.7%) #/ (%) Female 50/(89.3%) Ethnicity Not reported Disease/disability diagnosis CRPS INTERVENTION(S) AND CONTROL GROUPS Group 1: Intervention group 2

3 Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? The intervention group consisted of intensive physical, occupational, and cognitive behavioral therapies. Physical therapy consisted of weight-bearing exercises and exercises to improve strength, flexibility, and cardiovascular fitness. Both open-chain activities and closed-chain activities were incorporated. Occupational therapy interventions, although client centered and tailored to each individual patient, typically included fine motor precision tasks, ergonomic education, and leisure skill exploration. The researchers used sensory reeducation programs, including desensitization and sensory discrimination activities, to try to normalize the child s central nervous system. Overall, the main focus of occupational therapy was to maximize use of the affected limbs for independence and participation in self-care, school, and leisure activities. Furthermore, the researchers held 1-hour individual cognitive behavioral therapy sessions to address coping strategies (e.g., deep breathing, relaxation, guided imagery, biofeedback training) for the adolescents to learn a self-management approach to pain and functioning. Individual sessions also included problem-solving techniques to help the adolescents manage stressful life events, including pain. Family cognitive behavioral therapy sessions were held twice weekly to help parents to address pain that might have altered family interaction patterns and to promote positive functioning in their children. Daily academic time was also incorporated in the intervention, because it is imperative that adolescents, especially, stay up to date with schoolwork. Finally, individualized occupational therapy physical therapy home exercise programs were implemented to promote autonomy in managing the child s condition. These were to be completed nightly, on weekends, and postdischarge. Follow-up assessments of the adolescents pain and functioning were completed 2 24 months after discharge. The program had a rolling admissions process, with a maximum census of five patients in the program at a time. A total of 56 (N = 56) adolescents participated in the intervention group. The intervention took place in a day-hospital setting. Occupational and physical therapy services were delivered in rehabilitation gyms, whereas the cognitive behavioral services were delivered either individually in an office or in group format to enable opportunities for participants to learn from one another. A variety of physical therapists, occupational therapists, and cognitive behavioral therapists delivered the interdisciplinary, intensive rehabilitation in the day-hospital program. Furthermore, because the program was a day-hospital program, nurses and medical doctors also delivered medical and nursing services. 3

4 How often? For how long? The patients in the program underwent intensive physical, occupational, and cognitive behavioral therapy for 8 hour/day, 5 days/week. Furthermore, the family sessions were held twice a week. The typical duration of stay was about 3 weeks, although the exact stay varied from patient to patient, depending on the individual patient s progress toward rehabilitative goals. Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: NO Comment: Because there was no control group included in the study, contamination was avoided. Co-intervention: Timing: Site: NO Comment: Cointervention was not avoided, because participants of the study were allowed to remain on their designated pain medications throughout the intervention program, which could have altered the outcomes of the dayhospital program. Comment: The timing of the intervention program was sufficient, because it was not too long for maturation to affect the results, and it was not too short for a change to occur. A median stay of 3 weeks is in line with typical inpatient rehabilitation stays. However, the timing of the follow-up assessment was staggered and could have allowed for maturation of the adolescents to occur, given that some follow-up assessments were administered 24 months postdischarge. Comment: Treatment was delivered in the same day-hospital setting consistently throughout the intervention program. Use of different therapists to provide intervention: NR Comment: Although it was not specifically reported, the authors consistently referred to therapists in the plural sense of the word. Thus, it seems multiple therapists delivered the interventions. However, it is unknown whether more than one therapist from each discipline was assigned to a specific case for the duration of the intervention. 4

5 MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Numeric Rating Scale Name/type of Numeric Rating Scale measure used: What outcome was measured? Patients perceived pain ratings were measured on a scale of 0 10 (0 = no pain, 10 = worst pain possible). Is the measure reliable? Is the measure valid? When is the measure used? The researchers measured pain ratings at program admission and discharge to see whether a change occurred after several sessions of therapy. Measure 2: Functional Disability Inventory (FDI) Name/type of FDI (perception of physical and psychosocial functioning) measure used: What outcome was measured? The FDI measured degree to which patients experienced difficulty in physical and psychosocial functioning as a result of their physical health status. Respondents were asked to rate how much physical difficulty they perceived having for a variety of daily activities. They were asked to give ratings on the basis of experiences that occurred within the past 2 weeks. Is the measure reliable? Is the measure valid? When is the measure used? At program admission, discharge, and follow-up (2 24 months postdischarge) Measure 3: Canadian Occupational Performance Measure (COPM) Name/type of COPM (self-perception of occupational performance) measure used: What outcome was measured? Patients ratings of importance, performance, and satisfaction of daily activities were measured. In a semistructured interview, participants selfidentified priority performance difficulties in the domains of self-care, work and productivity, and leisure. Performance and satisfaction were rated on a 10-point Likert scale, with average scores derived. Is the measure reliable? Is the measure valid? When is the measure used? At program admission, discharge, and follow-up (2 24 months postdischarge) 5

6 Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. NR Comment: Not reported Recall or memory bias. Check yes, no, or NR, and if yes, explain. NR Others (list and explain): N/A Comment: Not reported RESULTS List key findings based on study objectives Participation rate in the day-hospital setting was excellent: Only 4 treatment days were missed across all participants (i.e., 4 patients each missed 1 day), because of reports of flulike symptoms. There was no day missed for refusal to participate because of pain or functional limitations, which further supports use of this interdisciplinary day-hospital approach. The results of the study demonstrate clinically and statistically significant improvements from admission to discharge in the following (results from secondary outcome measures also reported): pain intensity (p <.001), functional disability (p <.001), subjective report of limb function (p <.001), timed running (p <.001), occupational performance (p <.001), medication use (p <.01), use of assistive devices (p <.001), and emotional functioning (anxiety, p <.001; depression, p <.01). Objective data obtained from the Bruininks Oseretsky Test of Motor Proficiency determined a statistically significant change (p <.001) in physical functioning from admission to discharge. On the Lower Extremity Functional Scales (LEFS), 93% of children demonstrated clinically significant improvements (p <.05). In regard to the FDI, 65% (n = 46) of children had no to minimal disability at discharge, and 22% improved from severe disability to moderate disability. On the COPM, clinically significant improvements were reported by 89% of participants on both the Performance and the Satisfaction subscales. The children s school functioning was also found to have a significant improvement from admission to discharge (p <.05). Furthermore, it is to be noted that although a statistically significant improvement in pain intensity was identified at the group level, most patients (89.4% of those with complete data) continued to report some pain at discharge. In regard to the follow-up assessment of treatment outcomes (80% follow-up rate), selfreported functional abilities were maintained beyond discharge. However, 95% of participants with complete data (n = 41) showed clinically significant improvements on the LEFS scores at follow-up compared with admission, and 87.8% had maintained or 6

7 improved LEFS scores from discharge to follow-up. School functioning was also reassessed at follow-up, and it was found to have a significant improvement (p <.05) from admission to follow-up. Finally, 100% of participants with complete data (n = 45) showed clinically significant improvements on the COPM Performance scores at follow-up compared with admission, and 98% showed clinically significant improvement on COPM Satisfaction scores at follow-up versus admission. The effect size of the study was not reported. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. NR Comment: Not reported. However, the researchers did recognize that the study s small sample size was a limitation. For this reason, the researchers discussed the importance of replicating the findings from this small sample in large prospective studies. Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. Comment: Data were analyzed with PASW Statistics Version Admission and discharge scores were compared on all functional measures with paired t tests or Wilcoxon signed rank tests both appropriate analytic methods to compare outcomes over time. Repeated-measures analyses of variance (ANOVAs) were then used to assess changes across three time points (admission, discharge, and follow-up) on the FDI, LEFS, and COPM. This is appropriate, because more than two independent variables (more than two time periods, in this case) should be analyzed with an ANOVA. The researchers also reported that participants with missing data on an outcome measure were removed from relevant statistical analyses. Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. Comment: Yes, the statistics were appropriately reported in both written and table format. Both formats were easy to follow and understand. The tables clearly demonstrated the level of significance chosen, the pretest and posttest scores of the factor being analyzed, and what the outcomes meant in terms of statistical significance. Was the percent/number of subjects/participants who dropped out of the study reported? Limitations: What are the overall study limitations? Several limitations of this study exist. First and foremost, the small sample size used in this study warrants further research with larger, prospective sample sizes to further determine whether a statistically significant change occurs following the day-hospital program. 7

8 Furthermore, there was only one follow-up assessment, and the study included a relatively short window of time posttreatment. Also, this follow-up seemed to be brief in nature, and the time frame in which the follow-up assessment was administered varied across individuals. Moreover, participants were not randomized to treatment, nor did a comparison (control) group exist. The researchers identified the most significant limitation of this study to be its inability to isolate treatment effects from the natural course of the pain condition itself over time and development, and this holds true. The results of this study demonstrate promising effects of a day-hospital program for the treatment of pediatric CRPS, although a randomized controlled trial may be most effective in the future to further assess the mechanisms of changes in pain and function. CONCLUSIONS State the authors conclusions related to the research objectives. Although this study adds to the growing body of literature supporting an interdisciplinary approach to the treatment of pediatric CRPS, it also brings forth a new, promising method of treatment: a day-hospital program. The day-hospital program in this study (composed of physical, occupational, and cognitive behavioral therapies) yielded statistically significant changes in perceived pain intensity and functional disability, increased limb function, and improvements in occupational performance and satisfaction and emotional functioning. At discharge, participants left the program using significantly fewer pain medications and no assistive devices. At follow-up, patients continued to report improved function. Thus, this study demonstrates that an integrated approach can be delivered in a day-hospital setting to achieve successful results without the financial costs and disruptive effects of an inpatient hospitalization. This, in turn, led to an increase in quality of life for both patients and patients families. Further research is warranted given the limitations of the current study, as well as to elucidate the mechanisms underlying the benefits of pediatric pain rehabilitation. Furthermore, further research may help determine for whom the day-hospital program is most effective, predictors of time in treatment required to meet functional rehabilitative goals, and how treatments can be tailored to a broader range of children and adolescents with other forms of chronic pain and disability. This work is based on the evidence-based literature review completed by Natalie Quindlen, Colleen Maher, OTD, OTR/L, CHT, and Paula Kramer, PhD, OTR, FAOTA, faculty advisors, University of the Sciences. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: 8