Effectiveness and Cost-Effectiveness of a Stratified Blended Physiotherapy Intervention Compared With Face-to-Face Physiotherapy in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial.

BACKGROUND: Nonspecific low back pain (LBP) is a leading contributor to disability worldwide, and its socioeconomic burden is substantial. Self-management support is an important recommendation in clinical guidelines for the physiotherapy treatment of patients with LBP and may support cost-effective management. However, providing adequate individually tailored self-management support is difficult. The integration of web-based applications into face-to-face care (ie, blended care) seems promising to optimize tailored treatment and enhance patients' self-management and, consequently, may reduce LBP-related costs. OBJECTIVE: We aimed to evaluate the long-term effectiveness and cost-effectiveness of stratified blended physiotherapy (e-Exercise LBP) compared with face-to-face physiotherapy in patients with nonspecific LBP. METHODS: An economic evaluation was conducted alongside a prospective, multicenter, cluster randomized controlled trial in primary care physiotherapy. Patients with nonspecific LBP were treated with either stratified blended physiotherapy (e-Exercise LBP) (n=104) or face-to-face physiotherapy (n=104). The content of both interventions was based on the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients' risk of developing persistent LBP using the STarT Back Screening Tool. The primary clinical outcome was physical functioning (Oswestry Disability Index version 2.1a). For the economic evaluation, quality-adjusted life years (QALYs; EQ-5D-5L) and physical functioning were the primary outcomes. Secondary clinical outcomes included fear avoidance beliefs and self-reported adherence. Costs were measured from societal and health care perspectives using self-report questionnaires. Effectiveness was estimated using linear mixed models. Seemingly unrelated regression analyses were conducted to estimate total cost and effect differences for the economic evaluation. RESULTS: Neither clinically relevant nor statistically substantial differences were found between stratified blended physiotherapy and face-to-face physiotherapy regarding physical functioning (mean difference [MD] -1.1, 95% CI -3.9 to 1.7) and QALYs (MD 0.026, 95% CI -0.020 to 0.072) over 12 months. Regarding the secondary outcomes, fear avoidance beliefs showed a statistically significant improvement in favor of stratified blended physiotherapy (MD -4.3, 95% CI -7.3 to -1.3). Societal and health care costs were higher for stratified blended physiotherapy than for face-to-face physiotherapy, but the differences were not statistically significant (societal: €972 [US $1027], 95% CI -€1090 to €3264 [US -$1151 to $3448]; health care: €73 [US $77], 95% CI -€59 to €225 [US -$62 to $238]). Among the disaggregated cost categories, only unpaid productivity costs were significantly higher for stratified blended physiotherapy. From both perspectives, a considerable amount of money must be paid per additional QALY or 1-point improvement in physical functioning to reach a relatively low to moderate probability (ie, 0.23-0.81) of stratified blended physiotherapy being cost-effective compared with face-to-face physiotherapy. CONCLUSIONS: The stratified blended physiotherapy intervention e-Exercise LBP is neither more effective for improving physical functioning nor more cost-effective from societal or health care perspectives compared with face-to-face physiotherapy for patients with nonspecific LBP. TRIAL REGISTRATION: ISRCTN 94074203; https://www.isrctn.com/ISRCTN94074203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12891-020-3174-z.

Trajectories of Adherence to Home-Based Exercise Recommendations Among People With Low Back Pain: A Longitudinal Analysis.

OBJECTIVE: This study aimed to examine the presence of distinct trajectories of adherence to home-based exercise recommendations among people with low back pain (LBP). This study also aimed to identify differences in baseline characteristics among groups. METHODS: This study was a secondary analysis of a prospective, multicenter cluster randomized controlled trial investigating the cost-effectiveness of a stratified blended physical therapist intervention compared to usual care physical therapy in patients with LBP. The intervention group received usual care with integrated support via a smartphone app. A total of 208 patients were recruited from 58 primary care physical therapist practices. Baseline data included patient characteristics, physical functioning, pain intensity, physical activity, fear avoidance, pain catastrophizing, self-efficacy, self-management ability, and health-related quality of life. The Exercise Adherence Scale (score range = 0-100) was used to measure adherence during each treatment session. Latent class growth analysis was used to estimate trajectories of adherence. RESULTS: Adherence data were available from 173 out of 208 patients (83%). Data were collected during an average of 5.1 (standard deviation [SD] = 2.5) treatment sessions, with total treatment duration of 51 (SD = 41.7) days. Three trajectory classes were identified: "declining adherence" (12%), "stable adherence" (45%), and "increasing adherence" (43%). No differences in baseline characteristic were found between groups. CONCLUSION: Three adherence trajectories to exercise recommendations were identified in patients with LBP. However, baseline characteristics cannot identify a patient's trajectory group. IMPACT: Despite the presence of distinct trajectories of adherence in patients with LBP, physical therapists should not attempt to place a patient in a trajectory group at the start of treatment. Instead, adherence should be closely monitored as treatment progresses and supported when required as part of an ongoing process.

Patient Perspectives on Using a Smartphone App to Support Home-Based Exercise During Physical Therapy Treatment: Qualitative Study.

BACKGROUND: Home-based exercise is an important part of physical therapy treatment for patients with low back pain. However, treatment effectiveness depends heavily on patient adherence to home-based exercise recommendations. Smartphone apps designed to support home-based exercise have the potential to support adherence to exercise recommendations and possibly improve treatment effects. A better understanding of patient perspectives regarding the use of smartphone apps to support home-based exercise during physical therapy treatment can assist physical therapists with optimal use and implementation of these apps in clinical practice. OBJECTIVE: The aim of this study was to investigate patient perspectives on the acceptability, satisfaction, and performance of a smartphone app to support home-based exercise following recommendations from a physical therapist. METHODS: Using an interpretivist phenomenology approach, 9 patients (4 males and 5 females; aged 20-71 years) with nonspecific low back pain recruited from 2 primary care physical therapy practices were interviewed within 2 weeks after treatment ended. An interview guide was used for the interviews to ensure that different aspects of the patients' perspectives were discussed. The Physitrack smartphone app was used to support home-based exercise as part of treatment for all patients. Data were analyzed using the "Framework Method" to assist with interpretation of the data. RESULTS: Data analysis revealed 11 categories distributed among the 3 themes "acceptability," "satisfaction," and "performance." Patients were willing to accept the app as part of treatment when it was easy to use, when it benefited the patient, and when the physical therapist instructed the patient in its use. Satisfaction with the app was determined by users' perceived support from the app when exercising at home and the perceived increase in adherence. The video and text instructions, reminder functions, and self-monitor functions were considered the most important aspects for performance during treatment. The patients did not view the Physitrack app as a replacement for the physical therapist and relied on their therapist for instructions and support when needed. CONCLUSIONS: Patients who use an app to support home-based exercise as part of treatment are accepting of the app when it is easy to use, when it benefits the patient, and when the therapist instructs the patient in its use. Physical therapists using an app to support home-based exercise can use the findings from this study to effectively support their patients when exercising at home during treatment.

The 3-Month Effectiveness of a Stratified Blended Physiotherapy Intervention in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial.

BACKGROUND: Patient education, home-based exercise therapy, and advice on returning to normal activities are established physiotherapeutic treatment options for patients with nonspecific low back pain (LBP). However, the effectiveness of physiotherapy interventions on health-related outcomes largely depends on patient self-management and adherence to exercise and physical activity recommendations. e-Exercise LBP is a recently developed stratified blended care intervention comprising a smartphone app integrated with face-to-face physiotherapy treatment. Following the promising effects of web-based applications on patients' self-management skills and adherence to exercise and physical activity recommendations, it is hypothesized that e-Exercise LBP will improve patients' physical functioning. OBJECTIVE: This study aims to investigate the short-term (3 months) effectiveness of stratified blended physiotherapy (e-Exercise LBP) on physical functioning in comparison with face-to-face physiotherapy in patients with nonspecific LBP. METHODS: The study design was a multicenter cluster randomized controlled trial with intention-to-treat analysis. Patients with nonspecific LBP aged ≥18 years were asked to participate in the study. The patients were treated with either stratified blended physiotherapy or face-to-face physiotherapy. Both interventions were conducted according to the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients' risk of developing persistent LBP using the Keele STarT Back Screening Tool. The primary outcome was physical functioning (Oswestry Disability Index, range 0-100). Secondary outcomes included pain intensity, fear-avoidance beliefs, and self-reported adherence. Measurements were taken at baseline and at the 3-month follow-up. RESULTS: Both the stratified blended physiotherapy group (104/208, 50%) and the face-to-face physiotherapy group (104/208, 50%) had improved clinically relevant and statistically significant physical functioning; however, there was no statistically significant or clinically relevant between-group difference (mean difference -1.96, 95% CI -4.47 to 0.55). For the secondary outcomes, stratified blended physiotherapy showed statistically significant between-group differences in fear-avoidance beliefs and self-reported adherence. In patients with a high risk of developing persistent LBP (13/208, 6.3%), stratified blended physiotherapy showed statistically significant between-group differences in physical functioning (mean difference -16.39, 95% CI -27.98 to -4.79) and several secondary outcomes. CONCLUSIONS: The stratified blended physiotherapy intervention e-Exercise LBP is not more effective than face-to-face physiotherapy in patients with nonspecific LBP in improving physical functioning in the short term. For both stratified blended physiotherapy and face-to-face physiotherapy, within-group improvements were clinically relevant. To be able to decide whether e-Exercise LBP should be implemented in daily physiotherapy practice, future research should focus on the long-term cost-effectiveness and determine which patients benefit most from stratified blended physiotherapy. TRIAL REGISTRATION: ISRCTN Registry 94074203; https://doi.org/10.1186/ISRCTN94074203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-https://doi.org/10.1186/s12891-020-3174-z.

Measuring exercise adherence in patients with low back pain: development, validity, and reliability of the EXercise Adherence Scale (EXAS).

OBJECTIVES: To develop an instrument to measure adherence to frequency, intensity, and quality of performance of home-based exercise (HBE) programs recommended by a physical therapist and to evaluate its construct validity and reliability in patients with low back pain. METHODS: The Exercise Adherence Scale (EXAS) was developed following a literature search, an expert panel review, and a pilot test. The construct validity of the EXAS was determined based on data from 27 participants through an investigation of the convergent validity between adherence, lack of time to exercise, and lack of motivation to exercise. Associations between adherence, pain, and disability were determined to test divergent validity. The reliability of the EXAS quality of performance score was assessed using video recordings from 50 participants performing four exercises. RESULTS: Correlations between the EXAS and lack of time to exercise, lack of motivation to exercise, pain, and disability were rho = 0.47, rho = 0.48, rho = 0.005, and rho = 0.24, respectively. The intrarater reliability of the quality of performance score was Kappa quadratic weights (Kqw) = 0.87 (95%-CI 0.83-0.92). The interrater reliability was Kqw = 0.36 (95%-CI 0.27-0.45). CONCLUSIONS: The EXAS demonstrates acceptable construct validity for the measurement of adherence to HBE programs. Additionally, the EXAS shows excellent intrarater reliability and poor interrater reliability for the quality of performance score and is the first instrument to measure adherence to frequency, intensity, and quality of performance of HBE programs. The EXAS allows researchers and clinicians to better investigate the effects of adherence to HBE programs on the outcomes of interventions and treatments.

Effectiveness and cost-effectiveness of stratified blended physiotherapy in patients with non-specific low back pain: study protocol of a cluster randomized controlled trial.

BACKGROUND: Patient education, advice on returning to normal activities and (home-based) exercise therapy are established treatment options for patients with non-specific low back pain (LBP). However, the effectiveness of physiotherapy interventions on physical functioning and prevention of recurrent events largely depends on patient self-management, adherence to prescribed (home-based) exercises and recommended physical activity behaviour. Therefore we have developed e-Exercise LBP, a blended intervention in which a smartphone application is integrated within face-to-face care. E-Exercise LBP aims to improve patient self-management skills and adherence to exercise and physical activity recommendations and consequently improve the effectiveness of physiotherapy on patients' physical functioning. The aim of this study is to investigate the short- (3 months) and long-term (12 and 24 months) effectiveness on physical functioning and cost-effectiveness of e-Exercise LBP in comparison to usual primary care physiotherapy in patients with LBP. METHODS: This paper presents the protocol of a prospective, multicentre cluster randomized controlled trial. In total 208 patients with LBP pain were treated with either e-Exercise LBP or usual care physiotherapy. E-Exercise LBP is stratified based on the risk for developing persistent LBP. Physiotherapists are able to monitor and evaluate treatment progress between face-to-face sessions using patient input from the smartphone application in order to optimize physiotherapy care. The smartphone application contains video-supported self-management information, video-supported exercises and a goal-oriented physical activity module. The primary outcome is physical functioning at 12-months follow-up. Secondary outcomes include pain intensity, physical activity, adherence to prescribed (home-based) exercises and recommended physical activity behaviour, self-efficacy, patient activation and health-related quality of life. All measurements will be performed at baseline, 3, 12 and 24 months after inclusion. An economic evaluation will be performed from the societal and the healthcare perspective and will assess cost-effectiveness of e-Exercise LBP compared to usual physiotherapy at 12 and 24 months. DISCUSSION: A multi-phase development and implementation process using the Center for eHealth Research Roadmap for the participatory development of eHealth was used for development and evaluation. The findings will provide evidence on the effectiveness of blended care for patients with LBP and help to enhance future implementation of blended physiotherapy. TRIAL REGISTRATION: ISRCTN, ISRCTN94074203. Registered 20 July 2018 - Retrospectively registered.

Measurement Properties of the Quebec Back Pain Disability Scale in Patients With Nonspecific Low Back Pain: Systematic Review.

BACKGROUND: The Quebec Back Pain Disability Scale (QBPDS) has been translated into different languages, and several studies on its measurement properties have been done. PURPOSE: The purpose of this review was to critically appraise and compare the measurement properties, when possible, of all language versions of the QBPDS by systematically reviewing the methodological quality and results of the available studies. METHOD: Bibliographic databases (PubMed, Embase, CINAHL, and PsycINFO) were searched for articles with the key words "Quebec," "back," "pain," and "disability" in combination with a methodological search filter for finding studies on measurement properties concerning the development or evaluation of the measurement properties of the QBPDS in patients with nonspecific low back pain. Assessment of the methodological quality was carried out by the reviewers using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for both the original language version of the QBPDS in English and French and all translated versions. The results of the measurement properties were rated based on criteria proposed by Terwee et al. RESULTS: The search strategy resulted in identification of 1,436 publications, and 27 articles were included in the systematic review. There was limited-to-moderate evidence of good reliability, validity, and responsiveness of the QBPDS for the different language versions, but for no language version was evidence available for all measurement properties. CONCLUSION: For research and clinical practice, caution is advised when using the QBPDS to measure disability in patients with nonspecific low back pain. Strong evidence is lacking on all measurement properties for each language version of the QBPDS.

Using electronic medical records analysis to investigate the effectiveness of lifestyle programs in real-world primary care is challenging: a case study in diabetes mellitus.

OBJECTIVE: The increasing prevalence of diabetes suggests a gap between real world and controlled trial effectiveness of lifestyle interventions, but real-world investigations are rare. Electronic medical registration facilitates research on real-world effectiveness, although such investigations may require specific methodology and statistics. We investigated the effects of real-world primary care for patients with type 2 diabetes mellitus (T2DM). STUDY DESIGN AND SETTING: We used medical records of patients (n=2,549) with T2DM from 10 primary health care centers. A mixed-effects regression model for repeated measurements was used to evaluate the changes in weight and Hemoglobin A1c (HbA1c) over time. RESULTS: There was no statistically significant change in weight (+0.07 kg, P=0.832) and HbA1c (+0.03%, P=0.657) during the observation period of 972 days. Most patients maintained their physical activity level (70%), and 54 % had an insufficient activity level. The variability in the course of weight and HbA1c was because of differences between patients and not between health care providers. CONCLUSION: Despite effective lifestyle interventions in controlled trial settings, we found that real-world primary care is only able to stabilize weight and HbA1c in patients with T2DM over time. Medical registration can be used to monitor the actual effectiveness of interventions in primary care.

Pragmatic vs. explanatory: an adaptation of the PRECIS tool helps to judge the applicability of systematic reviews for daily practice.

OBJECTIVE: The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) tool was designed to classify randomized clinical trials (RCT) as being more pragmatic or explanatory. We modified the PRECIS tool (called PRECIS-Review tool [PR-tool]) to grade individual trials and systematic reviews of trials. This should help policy makers, clinicians, researchers, and guideline developers to judge the applicability of individual trials and systematic reviews. STUDY DESIGN AND SETTING: To illustrate the usefulness and applicability of the PR-tool, we applied it to two systematic reviews. Each included RCT was scored on the 10 PRECIS domains on a scale of 1-5. After this scoring, a 10-domain average for each individual trial and for the systematic review a single domain average and an overall average was calculated. RESULTS: One review was more pragmatic with an average score of 3.7 (range, 2.9-4.6) on our PR-tool, whereas the other review was more explanatory with an average score of 1.9 (range, 1.1-3.3). The results also suggest that the included studies within each systematic review were rather uniform in their approach, although some domains seemed more prone to heterogeneity. CONCLUSION: The PR-tool provides a useful estimate that gives insight by estimating quantitatively how pragmatic each RCT in the review is, which methodological domains are pragmatic or explanatory, and how pragmatic the review is.