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Evaluation of 'I-Preventive': a digital preventive tool for musculoskeletal disorders in computer workers-a pilot cluster randomised trial.

ABSTRACT: OBJECTIVES:I-Preventive is a digital preventive tool for musculoskeletal disorders (MSDs) in computer workers. We sought to determine its impact on pain in computer workers with upper limb MSDs and visual discomfort. METHODS:We conducted a pilot cluster randomised trial in 2 different sites of a tyre factory in France. We randomised 200 employees to either an intervention group (I-Preventive) or control group, each comprising symptomatic and asymptomatic employees. The workers were followed up for 5?months. The main outcome was overall recovery from symptoms following 1?month's intervention based on Nordic-style and eyestrain questionnaires. RESULTS:We included 185/200 workers: 96 in the intervention group (mean age 41.8±1.4?years; 88.5% males) and 79 in the control group (mean age 42.9±12.0?years; 94.5% males). The most painful areas (numerical scale ?2) were the neck (40.0%), upper back (18.8%) and shoulders (15.7%). For the most painful anatomical area, the Nordic score significantly decreased after 1?month in the intervention group (p=0.038); no change was observed in the control group (p=0.59). After 1?month's use, the intervention group reported less pain in the painful area and less visual discomfort symptoms (p=0.02). Adherence to the I-Preventive program was 60%. CONCLUSIONS:I-Preventive is effective in the short term on musculoskeletal symptoms and visual discomfort by promoting active breaks and eyestrain treatment. This easy-to-use digital tool allows each worker to focus on areas of their choice via personalised, easy exercises that can be performed in the workplace. TRIAL REGISTRATION NUMBER:NCT02350244; Pre-results.

SUBMITTER: Lanhers C

PROVIDER: S-EPMC5051336 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Evaluation of 'I-Preventive': a digital preventive tool for musculoskeletal disorders in computer workers-a pilot cluster randomised trial.

Lanhers C C Pereira B B Garde G G Maublant C C Dutheil F F Coudeyre E E

BMJ open 20160922 9

<h4>Objectives</h4>I-Preventive is a digital preventive tool for musculoskeletal disorders (MSDs) in computer workers. We sought to determine its impact on pain in computer workers with upper limb MSDs and visual discomfort.<h4>Methods</h4>We conducted a pilot cluster randomised trial in 2 different sites of a tyre factory in France. We randomised 200 employees to either an intervention group (I-Preventive) or control group, each comprising symptomatic and asymptomatic employees. The workers wer ...[more]

PMID: 27660316

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Project description:BackgroundMusculoskeletal conditions account for 16% of global disability, resulting in a negative effect on patients and increasing demand for health care use. Triage directing patients to appropriate level intervention improving health outcomes and efficiency has been prioritized. We developed a musculoskeletal digital assessment routing tool (DART) mobile health (mHealth) system, which requires evaluation prior to implementation. Such innovations are rarely rigorously tested in clinical trials-considered the gold standard for evaluating safety and efficacy. This pilot study is a precursor to a trial assessing DART performance with a physiotherapist-led triage assessment.ObjectiveThe study aims to evaluate trial design, assess procedures, and collect exploratory data to establish the feasibility of delivering an adequately powered, definitive randomized trial, assessing DART safety and efficacy in an NHS primary care setting.MethodsA crossover, noninferiority pilot trial using an integrated knowledge translation approach within a National Health Service England primary care setting. Participants were patients seeking assessment for a musculoskeletal condition, completing a DART assessment and the history-taking element of a face-to-face physiotherapist-led triage in a randomized order. The primary outcome was agreement between DART and physiotherapist triage recommendation. Data allowed analysis of participant recruitment and retention, randomization, blinding, study burden, and potential barriers to intervention delivery. Participant satisfaction was measured using the System Usability Scale.ResultsOver 8 weeks, 129 patients were invited to participate. Of these, 92% (119/129) proceeded to eligibility assessment, with 60% (78/129) meeting the inclusion criteria and being randomized into each intervention arm (39/39). There were no dropouts and data were analyzed for all 78 participants. Agreement between physiotherapist and DART across all participants and all primary triage outcomes was 41% (32/78; 95% CI 22-45), intraclass correlation coefficient 0.37 (95% CI 0.16-0.55), indicating that the reliability of DART was poor to moderate. Feedback from the clinical service team led to an adjusted analysis yielding of 78% (61/78; 95% CI 47-78) and an intraclass correlation coefficient of 0.57 (95% CI 0.40-0.70). Participant satisfaction was measured quantitively using amalgamated System Usability Scale scores (n=78; mean score 84.0; 90% CI +2.94 to -2.94), equating to an "excellent" system. There were no study incidents, and the trial burden was acceptable.ConclusionsPhysiotherapist-DART agreement of 78%, with no adverse triage decisions and high patient satisfaction, was sufficient to conclude DART had the potential to improve the musculoskeletal pathway. Study validity was enhanced by the recruitment of real-world patients and using an integrated knowledge translation approach. Completion of a context-specific consensus process is recommended to provide definitive definitions of safety criteria, range of appropriateness, noninferiority margin, and sample size. This pilot demonstrated an adequately powered definitive trial is feasible, which would provide evidence of DART safety and efficacy, ultimately informing potential for DART implementation.Trial registrationClinicalTrials.gov NCT04904029; http://clinicaltrials.gov/ct2/show/NCT04904029.International registered report identifier (irrid)RR2-10.2196/31541.

Project description:BackgroundMusculoskeletal conditions account for 16% of global disability, resulting in a negative effect on millions of patients and an increasing demand for health care use. Digital technologies to improve health care outcomes and efficiency are considered a priority; however, innovations are rarely tested with sufficient rigor in clinical trials, which is the gold standard for clinical proof of safety and efficacy. We have developed a new musculoskeletal digital assessment routing tool (DART) that allows users to self-assess and be directed to the right care. DART requires validation in a real-world setting before implementation.ObjectiveThis pilot study aims to assess the feasibility of a future trial by exploring the key aspects of trial methodology, assessing the procedures, and collecting exploratory data to inform the design of a definitive randomized crossover noninferiority trial to assess DART safety and effectiveness.MethodsWe will collect data from 76 adults with a musculoskeletal condition presenting to general practitioners within a National Health Service (NHS) in England. Participants will complete both a DART assessment and a physiotherapist-led triage, with the order determined by randomization. The primary analysis will involve an absolute agreement intraclass correlation (A,1) estimate with 95% CI between DART and the clinician for assessment outcomes signposting to condition management pathways. Data will be collected to allow the analysis of participant recruitment and retention, randomization, allocation concealment, blinding, data collection process, and bias. In addition, the impact of trial burden and potential barriers to intervention delivery will be considered. The DART user satisfaction will be measured using the system usability scale.ResultsA UK NHS ethics submission was done during June 2021 and is pending approval; recruitment will commence in early 2022, with data collection anticipated to last for 3 months. The results will be reported in a follow-up paper in 2022.ConclusionsThis study will inform the design of a randomized controlled crossover noninferiority study that will provide evidence concerning mobile health DART system clinical signposting in an NHS setting before real-world implementation. Success should produce evidence of a safe, effective system with good usability, potentially facilitating quicker and easier patient access to appropriate care while reducing the burden on primary and secondary care musculoskeletal services. This rigorous approach to mobile health system testing could be used as a guide for other developers of similar applications.Trial registrationClinicalTrials.gov NCT04904029; http://clinicaltrials.gov/ct2/show/NCT04904029.International registered report identifier (irrid)PRR1-10.2196/31541.

Project description:BackgroundMusculoskeletal disorders negatively affect millions of patients worldwide, placing significant demand on health care systems. Digital technologies that improve clinical outcomes and efficiency across the care pathway are development priorities. We developed the musculoskeletal Digital Assessment Routing Tool (DART) to enable self-assessment and immediate direction to the right care.ObjectiveWe aimed to assess and resolve all serious DART usability issues to create a positive user experience and enhance system adoption before conducting randomized controlled trials for the integration of DART into musculoskeletal management pathways.MethodsAn iterative, convergent mixed methods design was used, with 22 adult participants assessing 50 different clinical presentations over 5 testing rounds across 4 DART iterations. Participants were recruited using purposive sampling, with quotas for age, habitual internet use, and English-language ability. Quantitative data collection was defined by the constructs within the International Organization for Standardization 9241-210-2019 standard, with user satisfaction measured by the System Usability Scale. Study end points were resolution of all grade 1 and 2 usability problems and a mean System Usability Scale score of ≥80 across a minimum of 3 user group sessions.ResultsAll participants (mean age 48.6, SD 15.2; range 20-77 years) completed the study. Every assessment resulted in a recommendation with no DART system errors and a mean completion time of 5.2 (SD 4.44, range 1-18) minutes. Usability problems were reduced from 12 to 0, with trust and intention to act improving during the study. The relationship between eHealth literacy and age, as explored with a scatter plot and calculation of the Pearson correlation coefficient, was performed for all participants (r=-0.2; 20/22, 91%) and repeated with a potential outlier removed (r=-0.23), with no meaningful relationships observed or found for either. The mean satisfaction for daily internet users was highest (19/22, 86%; mean 86.5, SD 4.48; 90% confidence level [CL] 1.78 or -1.78), with nonnative English speakers (6/22, 27%; mean 78.1, SD 4.60; 90% CL 3.79 or -3.79) and infrequent internet users scoring the lowest (3/22, 14%; mean 70.8, SD 5.44; 90% CL 9.17 or -9.17), although the CIs overlap. The mean score across all groups was 84.3 (SD 4.67), corresponding to an excellent system, with qualitative data from all participants confirming that DART was simple to use.ConclusionsAll serious DART usability issues were resolved, and a good level of satisfaction, trust, and willingness to act on the DART recommendation was demonstrated, thus allowing progression to randomized controlled trials that assess safety and effectiveness against usual care comparators. The iterative, convergent mixed methods design proved highly effective in fully evaluating DART from a user perspective and could provide a blueprint for other researchers of mobile health systems.International registered report identifier (irrid)RR2-10.2196/27205.

Dataset Information

Evaluation of 'I-Preventive': a digital preventive tool for musculoskeletal disorders in computer workers-a pilot cluster randomised trial.

Publications

Evaluation of 'I-Preventive': a digital preventive tool for musculoskeletal disorders in computer workers-a pilot cluster randomised trial.

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