OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy.METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed.CONCLUSION: This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.
BACKGROUND: We recently developed a model of stratified exercise therapy, consisting of (i) a stratification algorithm allocating patients with knee osteoarthritis (OA) into one of the three subgroups ('high muscle strength subgroup' representing a post-traumatic phenotype, 'low muscle strength subgroup' representing an age-induced phenotype, and 'obesity subgroup' representing a metabolic phenotype) and (ii) subgroup-specific exercise therapy. In the present study, we aimed to test the construct validity of this algorithm.METHODS: Data from five studies (four exercise therapy trial cohorts and one cross-sectional cohort) were used to test the construct validity of our algorithm by 63 a priori formulated hypotheses regarding three research questions: (i) are the proportions of patients in each subgroup similar across cohorts? (15 hypotheses); (ii) are the characteristics of each of the subgroups in line with their proposed underlying phenotypes? (30 hypotheses); (iii) are the effects of usual exercise therapy in the 3 subgroups in line with the proposed effect sizes? (18 hypotheses).RESULTS: Baseline data from a total of 1211 patients with knee OA were analyzed for the first and second research question, and follow-up data from 584 patients who were part of an exercise therapy arm within a trial for the third research question. In total, the vast majority (73%) of the hypotheses were confirmed. Regarding our first research question, we found similar proportions in each of the three subgroups across cohorts, especially for three cohorts. Regarding our second research question, subgroup characteristics were almost completely in line with the proposed underlying phenotypes. Regarding our third research question, usual exercise therapy resulted in similar, medium to large effect sizes for knee pain and physical function for all three subgroups.CONCLUSION: We found mixed results regarding the construct validity of our stratification algorithm. On the one hand, it is a valid instrument to consistently allocate patients into subgroups that aligned our hypotheses. On the other hand, in contrast to our hypotheses, subgroups did not differ substantially in effects of usual exercise therapy. An ongoing trial will assess whether this algorithm accompanied by subgroup-specific exercise therapy improves clinical and economic outcomes.
MULTIFILE
Background: Recent technological developments such as wearable sensors and tablets with a mobile internet connection hold promise for providing electronic health home-based programs with remote coaching for patients following total hip arthroplasty. It can be hypothesized that such a home-based rehabilitation program can offer an effective alternative to usual care.Objective: The aim of this study was to determine the effectiveness of a home-based rehabilitation program driven by a tablet app and remote coaching for patients following total hip arthroplasty.Methods: Existing data of two studies were combined, in which patients of a single-arm intervention study were matched with historical controls of an observational study. Patients aged 18-65 years who had undergone total hip arthroplasty as a treatment for primary or secondary osteoarthritis were included. The intervention consisted of a 12-week home-based rehabilitation program with video instructions on a tablet and remote coaching (intervention group). Patients were asked to do strengthening and walking exercises at least 5 days a week. Data of the intervention group were compared with those of patients who received usual care (control group). Effectiveness was measured at four moments (preoperatively, and 4 weeks, 12 weeks, and 6 months postoperatively) by means of functional tests (Timed Up & Go test and the Five Times Sit-to Stand Test) and self-reported questionnaires (Hip disability and Osteoarthritis Outcome Score [HOOS] and Short Form 36 [SF-36]). Each patient of the intervention group was matched with two patients of the control group. Patient characteristics were summarized with descriptive statistics. The 1:2 matching situation was analyzed with a conditional logistic regression. Effect sizes were calculated by Cohen d.Results: Overall, 15 patients of the intervention group were included in this study, and 15 and 12 subjects from the control group were matched to the intervention group, respectively. The intervention group performed functional tests significantly faster at 12 weeks and 6 months postoperatively. The intervention group also scored significantly higher on the subscales "function in sport and recreational activities" and "hip-related quality of life" of HOOS, and on the subscale "physical role limitations" of SF-36 at 12 weeks and 6 months postoperatively. Large effect sizes were found on functional tests at 12 weeks and at 6 months (Cohen d=0.5-1.2), endorsed by effect sizes on the self-reported outcomes.Conclusions: Our results clearly demonstrate larger effects in the intervention group compared to the historical controls. These results imply that a home-based rehabilitation program delivered by means of internet technology after total hip arthroplasty can be more effective than usual care.Keywords: home-based rehabilitation program; internet; osteoarthritis; physiotherapy; rehabilitation; remote coaching; tablet app; total hip arthroplasty; total hip replacement; usual care.
