Treatment Effect Modifiers for Return-to-Work in Patients With Musculoskeletal Disorders.

Investigating how individual characteristics modify treatment effects can improve understanding, interpretation, and translation of trial findings. The purpose of this secondary analysis was to identify treatment effect modifiers of the MI-NAV trial, a 3 arm, parallel randomized controlled trial which compared motivational interviewing and stratified vocational advice intervention in addition to usual case management (UC), to UC alone. This study included (n = 514) participants with musculoskeletal disorders on sick leave for at least 50% of their contracted work hours for at least 7 consecutive weeks with the Norwegian Labour and Welfare Administration. Sickness absence days was the primary outcome, measured from baseline assessment date until the 6-month follow-up. Potential treatment effect modifiers, identified a priori and informed by expert consultation and literature, were evaluated using linear regression models and statistical interaction tests. For motivational interviewing versus UC, age (mean difference [MD] -.7, 95% confidence interval [CI] -1.5 to .2; P = .13) and self-perceived health status (MD -.3, 95% CI -.7 to .1; P = .19) were identified as potential effect modifiers (P ≤ .2). For stratified vocational advice intervention versus UC, analgesic medication use (MD -26.2, 95% CI -45.7 to -6.7; P = .009) was identified as a treatment effect modifier (P ≤ .05). These findings may assist in more targeted treatment adaptation and translation as well as the planning of future clinical trials. PERSPECTIVE: This secondary analysis of the MI-NAV trial found that analgesic medication use, age, and self-perceived health may modify the effect of 2 vocational interventions on reducing sickness absence in people with musculoskeletal disorders.

Six-month cost-effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management for workers with musculoskeletal disorders: the MI-NAV economic evaluation.

OBJECTIVES: This study evaluates the six-month cost-effectiveness and cost-benefits of motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) added to usual case management (UC) for workers on sick leave due to musculoskeletal disorders. METHODS: This study was conducted alongside a three-arm RCT including 514 employed workers on sick leave for at least 50% for ≥ 7 weeks. All participants received UC. The UC + MI group received two MI sessions, and the UC + SVAI group received 1-4 SVAI sessions. Sickness absence days, quality-adjusted life-years (QALYs), and societal costs were measured between baseline and six months. RESULTS: Adding MI to UC, resulted in incremental cost-reduction of -2580EUR (95%CI -5687;612), and a reduction in QALYs of -0.001 (95%CI -0.02;0.01). Secondly, adding MI to UC resulted in an incremental cost-reduction of -538EUR (95%CI -1358;352), and reduction of 5.08 (95%CI -3.3;13.5) sickness-absence days. Financial return estimates were positive, but not statistically significant. Adding SVAI to UC, resulted in an incremental cost-reduction of -2899 EUR (95% CI -5840;18), and a reduction in QALYs of 0.002 (95% CI -0.02;0.01). Secondly, adding SVAI to UC resulted in an statistically significant incremental cost-reduction of -695 EUR (95% CI -1459;-3), and a reduction of 7.9 (95% CI -0.04;15.9) sickness absence days. Financial return estimates were positive and statistically significant. The probabilities of cost-effectiveness for QALYs were high for adding MI or SVAI (ceiling ratio 0.90). CONCLUSIONS: In comparison to UC only, adding MI to UC tends to be cost-effective. Adding SVAI to UC is cost-effective for workers on sick leave due to musculoskeletal disorders. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03871712).

Mechanisms of vocational interventions for return to work from musculoskeletal conditions: a mediation analysis of the MI-NAV trial.

OBJECTIVES: To investigate whether and to what extent, return to work (RTW) expectancy and workability mediate the effect of two vocational interventions on reducing sickness absence in workers on sick leave from a musculoskeletal condition. METHODS: This is a preplanned mediation analysis of a three-arm parallel randomised controlled trial which included 514 employed working adults with musculoskeletal conditions on sick leave for at least 50% of their contracted work hours for ≥7 weeks. Participants were randomly allocated (1:1:1) to one of three treatment arms; usual case management (UC) (n=174), UC plus motivational interviewing (MI) (n=170) and UC plus a stratified vocational advice intervention (SVAI) (n=170). The primary outcome was the number of sickness absence days over 6 months from randomisation. Hypothesised mediators included RTW expectancy and workability assessed 12 weeks after randomisation. RESULTS: The mediated effect of the MI arm compared with UC on sickness absence days through RTW expectancy was -4.98 days (-8.89 to -1.04), and workability was -3.17 days (-8.55 to 2.32). The mediated effect of the SVAI arm compared with UC on sickness absence days through RTW expectancy was -4.39 days (-7.60 to -1.47), and workability was -3.21 days (-7.90 to 1.50). The mediated effects for workability were not statistically significant. CONCLUSIONS: Our study provides new evidence for the mechanisms of vocational interventions to reduce sickness absence related to sick leave due to musculoskeletal conditions. Changing an individual's expectation that RTW is likely may result in meaningful reductions in sickness absence days. TRIAL REGISTRATION NUMBER: NCT03871712.

Effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders: the MI-NAV randomised controlled trial.

OBJECTIVES: To evaluate if adding motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) to usual case management (UC), reduced sickness absence over 6 months for workers on sick leave due to musculoskeletal disorders. METHODS: We conducted a three-arm parallel pragmatic randomised controlled trial including 514 employed workers (57% women, median age 49 (range 24-66)), on sick leave for at least 50% of their contracted work hours for ≥7 weeks. All participants received UC. In addition, those randomised to UC+MI were offered two MI sessions from social insurance caseworkers and those randomised to UC+SVAI were offered vocational advice from physiotherapists (participants with low/medium-risk for long-term sickness absence were offered one to two sessions, and those with high-risk were offered three to four sessions). RESULTS: Median sickness absence was 62 days, (95% CI 52 to 71) in the UC arm (n=171), 56 days (95% CI 43 to 70) in the UC+MI arm (n=169) and 49 days (95% CI 38 to 60) in the UC+SVAI arm (n=169). After adjusting for predefined potential confounding factors, the results showed seven fewer days in the UC+MI arm (95% CI -15 to 2) and the UC+SVAI arm (95% CI -16 to 1), compared with the UC arm. The adjusted differences were not statistically significant. CONCLUSIONS: The MI-NAV trial did not show effect on return to work of adding MI or SVAI to UC. The reduction in sickness absence over 6 months was smaller than anticipated, and uncertain due to wide CIs. TRIAL REGISTRATION NUMBER: NCT03871712.

Implementing a Stratified Vocational Advice Intervention for People on Sick Leave with Musculoskeletal Disorders: A Multimethod Process Evaluation.

Purpose To perform a process evaluation of a stratified vocational advice intervention (SVAI), delivered by physiotherapists in primary care, for people on sick leave with musculoskeletal disorders participating in a randomised controlled trial. The research questions concerned how the SVAI was delivered, the content of the SVAI and the physiotherapists' experiences from delivering the SVAI. Methods We used qualitative and quantitative data from 148 intervention logs documenting the follow-up provided to each participant, recordings of 18 intervention sessions and minutes from 20 meetings with the physiotherapists. The log data were analysed with descriptive statistics. A qualitative content analysis was performed of the recordings, and we identified facilitators and barriers for implementation from the minutes. Results Of 170 participants randomised to the SVAI 152 (89%) received the intervention and 148 logs were completed. According to the logs, 131 participants received the correct number of sessions (all by telephone) and 146 action plans were developed. The physiotherapists did not attend any workplace meetings but contacted stakeholders in 37 cases. The main themes from the recorded sessions were: 'symptom burden', 'managing symptoms', 'relations with the workplace' and 'fear of not being able to manage work'. The physiotherapists felt they were able to build rapport with most participants. However, case management was hindered by the restricted number of sessions permitted according to the protocol. Conclusion Overall, the SVAI was delivered in accordance with the protocol and is therefore likely to be implementable in primary care if it is effective in reducing sick leave.

Fidelity of a Motivational Interviewing Intervention for Improving Return to Work for People with Musculoskeletal Disorders.

The objective of this study was to conduct a fidelity evaluation of a motivational interviewing (MI) intervention delivered by social insurance caseworkers, in a three-arm randomized controlled trial (RCT) for improving return to work for people on sick leave with musculoskeletal disorders. The caseworkers received six days of MI training, including an intervention manual prior to the trial onset, as well as supervision throughout the trial. The caseworkers recorded 21 MI sessions at regular intervals during the trial. An independent MI analysis center scored the recordings using the MI treatment integrity code (MITI 4). In addition, three experienced MI trainers assessed the adherence to the MI intervention manual on a 1-4 Likert scale and MI competence. Total MITI 4 mean scores were at beginning proficiency levels for two components (global technical, mean 3.0; SD 0.6 and the reflections/questions ratio, mean 1.1; SD 0.2) and under beginning proficiency for two components (global relational, mean 3.2; SD 0.7 and complex question, mean 34.0; SD 21.2). The MI trainers' assessment showed similar results. The mean adherence score for the MI sessions was 2.96 (SD 0.9). Despite delivering a thorough course and supervision package, most of the caseworkers did not reach proficiency levels of good MI competence during the study. The fidelity evaluation showed that a large amount of training, supervision and practice is needed for caseworkers to become competent MI providers. When planning to implement MI, it is important that thorough consideration is given regarding the resources and the time needed to train caseworkers to provide MI in a social insurance setting.

Motivational Interviewing and Return to Work for People with Musculoskeletal Disorders: A Systematic Mapping Review.

Purpose There is limited knowledge about motivational interviewing (MI) for people on sick leave with musculoskeletal disorders. Hence, our objective was to investigate what research on MI as a method to facilitate return to work for individuals who are on sick leave due to musculoskeletal disorders exists, and what are the results of the research? Methods We systematically searched MEDLINE, PsycINFO, EMBASE, Cochrane Library, CINAHL, Web of Science, Sociological Abstracts, Epistemonikos, SveMed + and DARE & HTA (covering 1983 to August 2019). We also searched the MINT bulletin and relevant web pages. Eligibility criteria: empirical studies investigating MI and return to work for people with musculoskeletal disorders. Two authors independently screened the records, critically appraised the studies and charted the data using a data extraction form. Results The searches identified 1264 records of which two studies were included. One randomized controlled trial (RCT) found no effect of MI on return to work for disability pensioner with back pain (n = 89, high risk of bias), while a cluster RCT found that MI increased return to work for claimants with chronic musculoskeletal disorders (n = 728, low risk of bias). Conclusions This mapping review identified a huge gap in research on MI to increase return to work for individuals with musculoskeletal disorders. Registration Current Research Information System in Norway, project id: 635823 ( https://app.cristin.no/projects/show.jsf?id=635823 ).

Study protocol for a randomized controlled trial of the effectiveness of adding motivational interviewing or stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders. The MI-NAV study.

BACKGROUND: Little research exists on the effectiveness of motivational interviewing (MI) on return to work (RTW) in workers on long term sick leave. The objectives of this study protocol is to describe a randomized controlled trial (RCT) with the objectives to compare the effectiveness and cost-effectiveness of usual case management alone with usual case management plus MI or usual case management plus stratified vocational advice intervention (SVAI), on RTW among people on sick leave due to musculoskeletal (MSK) disorders. METHODS: A multi-arm RCT with economic evaluation will be conducted in Norway with recruitment of 450 participants aged 18-67 years on 50-100% sick leave for > 7 weeks due to MSK disorders. Participants will be randomized to either usual case management by the Norwegian Labour and Welfare Administration (NAV) alone, usual case management by NAV plus MI, or usual case management by NAV plus SVAI. Trained caseworkers in NAV will give two MI sessions, and physiotherapists will give 1-4 SVAI sessions depending upon risk of long-term sick leave. The primary outcome is the number of sick leave days from randomization to 6 months follow-up. Secondary outcomes are number of sick leave days at 12 months follow-up, time until sustainable RTW (≥4 weeks of at least 50% of their usual working hours) at 12 months, proportions of participants receiving sick leave benefits during 12 months of follow-up, and MSK symptoms influencing health at 12 months. Cost-utility evaluated by the EuroQoL 5D-5L and cost-benefit analyses will be performed. Fidelity of the interventions will be assessed through audio-recordings of approximately 10% of the intervention sessions. DISCUSSION: The results from this RCT will inform stakeholders involved in supporting RTW due to MSK disorders such as staff within NAV and primary health care. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03871712 registered March 12th 2020.

Risk assessment for prolonged sickness absence due to musculoskeletal disorders: protocol for a prospective cohort study.

BACKGROUND: Musculoskeletal disorders are the leading cause of sickness absence and disability pension in Norway. There is strong evidence that long-term sickness absence due to musculoskeletal disorders are associated with a reduced probability of return to work (RTW). A way to meet the economic and resource-demanding challenges related to individual follow-up of this group is to identify and treat those individuals with a high risk of prolonged sickness. The overall purposes of this project are 1) to determine the most accurate screening tool to identify people at a high risk of prolonged sickness absence due to an musculoskeletal disorder, and 2) to investigate severity of musculoskeletal health, health-related quality-of-life, health care utilization, and costs across different risk profiles in people on sick leave due to a musculoskeletal disorder. METHODS: People older than 18 years of age on sick leave for at least 4 weeks due to a musculoskeletal disorder will be invited to participate in this prospective observational cohort study conducted within the Norwegian Welfare and Labor Administration (NAV) system in collaboration with OsloMet - Oslo Metropolitan University. The main outcome is sickness absence, obtained from the NAV registry. Data on sickness absence will be retrieved prospectively in the period from study inclusion to 12 months follow-up, and retrospectively 12 months before inclusion in the study. Possible risk factors will be self-reported by the participants at inclusion while health care utilization will be retrieved from registry data. To conduct analyses including 15 to 20 predictor variables, we aim at including 500-600 people on sick leave due to musculoskeletal disorders. DISCUSSION: This study may provide tools that can be used to identify individuals with high risk of prolonged sickness absence and may thus be important from both a socioeconomic and individual perspective. Further, the study may give valuable insight into identification of sickness absence profiles and the associations between these profiles and musculoskeletal health status, health-related quality of life and costs. TRIAL REGISTRATION: Retrospectively registered in ClinicalTrials.gov (NCT04196634, 27.11.2019).

Gender differences in subjective health complaints in adolescence: The roles of self-esteem, stress from schoolwork and body dissatisfaction.

AIMS: The aims of this study were to examine subjective health complaints among Norwegian adolescents and assess the development of gender differences in subjective health complaints between age 14 and 16; to investigate whether self-esteem, stress from schoolwork or body dissatisfaction affected adolescents' subjective health complaints; and determine whether these factors could explain the excess of subjective health complaints among girls. METHODS: We used multiple linear regression analyses to analyse longitudinal survey data from 751 Norwegian adolescents at the ages of 14 and 16. The results from various cross-sectional and prospective analyses were compared. RESULTS: Girls reported more subjective health complaints than boys, and gender differences increased from age 14 to 16. Self-esteem and stress from schoolwork had cross-sectional and prospective associations with subjective health complaints. Stress from schoolwork at age 14 was also associated with changes in subjective health complaints from age 14 to 16. The cross-sectional mediation analyses indicated that self-esteem and stress from schoolwork accounted for 61% of the excess of subjective health complaints among girls at age 16. The same variables measured at age 14 accounted for 24% of the gender differences in subjective health complaints two years later. The investigated factors could not account for the increase in gender differences in subjective health complaints between ages 14 and 16. CONCLUSIONS: The findings showed that self-esteem and stress from schoolwork were associated with subjective health complaints during adolescence. These factors could partially explain the excess of subjective health complaints among girls.