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.

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.

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.

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.

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.

Translation, Validation, and Reliability of the Dutch Late-Life Function and Disability Instrument Computer Adaptive Test.

BACKGROUND: Adequate and user-friendly instruments for assessing physical function and disability in older adults are vital for estimating and predicting health care needs in clinical practice. The Late-Life Function and Disability Instrument Computer Adaptive Test (LLFDI-CAT) is a promising instrument for assessing physical function and disability in gerontology research and clinical practice. OBJECTIVE: The aims of this study were: (1) to translate the LLFDI-CAT to the Dutch language and (2) to investigate its validity and reliability in a sample of older adults who spoke Dutch and dwelled in the community. DESIGN: For the assessment of validity of the LLFDI-CAT, a cross-sectional design was used. To assess reliability, measurement of the LLFDI-CAT was repeated in the same sample. METHODS: The item bank of the LLFDI-CAT was translated with a forward-backward procedure. A sample of 54 older adults completed the LLFDI-CAT, World Health Organization Disability Assessment Schedule 2.0, RAND 36-Item Short-Form Health Survey physical functioning scale (10 items), and 10-Meter Walk Test. The LLFDI-CAT was repeated in 2 to 8 days (mean=4.5 days). Pearson's r and the intraclass correlation coefficient (ICC) (2,1) were calculated to assess validity, group-level reliability, and participant-level reliability. RESULTS: A correlation of .74 for the LLFDI-CAT function scale and the RAND 36-Item Short-Form Health Survey physical functioning scale (10 items) was found. The correlations of the LLFDI-CAT disability scale with the World Health Organization Disability Assessment Schedule 2.0 and the 10-Meter Walk Test were -.57 and -.53, respectively. The ICC (2,1) of the LLFDI-CAT function scale was .84, with a group-level reliability score of .85. The ICC (2,1) of the LLFDI-CAT disability scale was .76, with a group-level reliability score of .81. LIMITATIONS: The high percentage of women in the study and the exclusion of older adults with recent joint replacement or hospitalization limit the generalizability of the results. CONCLUSIONS: The Dutch LLFDI-CAT showed strong validity and high reliability when used to assess physical function and disability in older adults dwelling in the community.