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.

Modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders: findings from an occupational cohort study.

OBJECTIVES: The objective was to identify modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders, and to identify modifiable prognostic factors of high costs related to separately healthcare utilisation and productivity loss. DESIGN: A prospective cohort study with a 1-year follow-up. PARTICIPANTS AND SETTING: A total of 549 participants (aged 18-67 years) on sick leave (≥ 4 weeks) due to musculoskeletal disorders in Norway were included. OUTCOME MEASURES AND METHOD: The primary outcome was societal costs aggregated for 1 year of follow-up and dichotomised as high or low, defined by the top 25th percentile. Secondary outcomes were high costs related to separately healthcare utilisation and productivity loss aggregated for 1 year of follow-up. Healthcare utilisation was collected from public records and included primary, secondary and tertiary healthcare use. Productivity loss was collected from public records and included absenteeism, work assessment allowance and disability pension. Nine modifiable prognostic factors were selected based on previous literature. Univariable and multivariable binary logistic regression analyses were performed to identify associations (crude and adjusted for selected covariates) between each modifiable prognostic factor and having high costs. RESULTS: Adjusted for selected covariates, six modifiable prognostic factors associated with high societal costs were identified: pain severity, disability, self-perceived health, sleep quality, return to work expectation and long-lasting disorder expectation. Depressive symptoms, work satisfaction and health literacy showed no prognostic value. More or less similar results were observed when high costs were related to separately healthcare utilisation and productivity loss. CONCLUSION: Factors identified in this study are potential target areas for interventions which could reduce high societal costs among people on sick leave due to musculoskeletal disorders. However, future research aimed at replicating these findings is warranted. TRIAL REGISTRATION NUMBER: NCT04196634, 12 December 2019.

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.

Effectiveness of work-related interventions for return to work in people on sick leave: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Long-term sick leave is a serious concern in developed countries and the cost of sickness absence and disability benefits cause major challenges for both the individual and society as a whole. Despite an increasing body of research reported by existing systematic reviews, there is uncertainty regarding the effect on return to work of workrelated interventions for workers with different diagnoses. The objective of this systematic review was to assess and summarize available research about the effects of work-related interventions for people on long-term sick leave and those at risk of long-term sick leave. METHODS: We conducted a systematic review in accordance with international guidelines. Campbell Collaboration (Area: Social Welfare), Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Embase, Epistemonikos, MEDLINE, PsycINFO, Scopus, and Sociological Abstracts were systematically searched in March 2021. Two authors independently screened the studies. We conducted risk of bias assessments and meta-analyses of the available evidence in randomized controlled trials (RCTs). The remaining comparisons were synthesized narratively. The certainty of evidence for each outcome was assessed. RESULTS: We included 20 RCTs comprising 5753 participants at baseline from 4 different countries. The studies had generally low risk of bias. Our certainty in the effect estimates ranged from very low to moderate. Eight different interventions were identified. Meta-analysis revealed no statistically significant difference between multidisciplinary rehabilitation (MR) and usual care (US) (Risk Ratio [RR] 1.01; Confidence Interval [CI] 95% 0.70-1.48 at 12 months follow-up) and between MR and other active intervention (Risk Ratio [RR] 1.04; Confidence Interval [CI] 95% 0.86-1.25 at 12 months follow-up). Remaining intervention groups revealed marginal, or no effect compared to the control group. The results for the secondary outcomes (self-efficacy, symptom reduction, function, cost-effectiveness) showed varied and small effects in the intervention groups. CONCLUSION: Overall, the present data showed no conclusive evidence of which work-related intervention is most effective for return to work. However, a handful of potential interventions exist, that may contribute to a foundation for future research. Our findings support the need for adequately powered and methodologically strong studies.

Stratifying workers on sick leave due to musculoskeletal pain: translation, cross-cultural adaptation and construct validity of the Norwegian Keele STarT MSK tool.

OBJECTIVES: Stratified care using prognostic models to estimate the risk profiles of patients has been increasing. A refined version of the popular STarT Back tool, the Keele STarT MSK tool, is a newly developed model for matched treatment across a wide range of musculoskeletal pain presentations. The aim of this study was to translate and culturally adapt the Keele STarT MSK tool into Norwegian, examine its construct validity and assess the representativeness of the included sample. METHODS: The Keele STarT MSK tool was formally translated into Norwegian following a multistep approach of forward and backward translation. A pre-final version was tested in 42 patients. Minor changes were implemented. To assess its construct validity, an online survey was conducted among workers aged 18-67 years who were on sick leave (>4 weeks) due to musculoskeletal disorders. Construct validity was evaluated in terms of convergent and discriminant validity using Pearson's correlation coefficient, and known-group validity by comparing risk subgroups as suggested by the COSMIN checklist. The representativeness of the sample was assessed by comparing demographic and sick leave information of participants to eligible non-participants (n=168,137). RESULTS: A representative sample of 549 workers participated in the validity assessment; 74 participants (13.5%) were categorised as low risk, 314 (57.2%) as medium risk and 161 (29.3%) as high risk. The construct validity was found sufficient, with 90.9% and 75.0% of the pre-defined hypotheses confirmed for convergent and discriminant validity, and known-group validity, respectively. Floor or ceiling effects were not found. CONCLUSIONS: The Keele STarT MSK tool was successfully translated into Norwegian. The construct validity of the tool was acceptable in a representative cohort of workers on sick leave as a result of musculoskeletal pain. However, the analyses raised concerns as to whether one of the questions captures the construct it is intended to measure.

Validity and reliability of the Norwegian version of the Musculoskeletal Health Questionnaire in people on sick leave.

BACKGROUND: The Musculoskeletal Health Questionnaire (MSK-HQ) is a recently developed generic questionnaire that consists of 14 items assessing health status in people with musculoskeletal disorders. The objective was to translate and cross-culturally adapt the MSK-HQ into Norwegian and to examine its construct validity and reliability in people on sick leave with musculoskeletal disorders. METHODS: A prospective cohort study was carried out in Norway on people between 18 and 67 years of age and sick leave due to a musculoskeletal disorder. The participants were recruited through the Norwegian Labour and Welfare Administration during November 2018-January 2019 and responded to the MSK-HQ at inclusion and after four weeks. Internal consistency was assessed by Cronbach's alpha, and structural validity with a factor analysis. Construct validity was assessed by eight "a priori" defined hypotheses regarding correlations between the MSK-HQ and other reference scales. Correlations were analyzed by Spearman's- or Pearson's correlation coefficient and interpreted as high with values ≥ 0.50, moderate between 0.30-0.49, and low < 0.29. Reliability was tested with test-retest, standard error of measurement (SEM) and smallest detectable change (SDC). RESULTS: A total of 549 patients, mean age (SD) 48.6 (10.7), 309 women (56.3%), were included. The mean (SD) MSK-HQ sum scores (min-max 3-56) were 27.7 (8.2). Internal consistency was 0.86 and a three-factor structure was determined by factor analysis. Construct validity was supported by the confirmation of all hypotheses; high correlation with HRQOL, psychosocial risk profile, and self-perceived health; moderate correlation with physical activity, self-perceived work ability, and work presenteeism; and low correlation with the number of sick days. The test-retest reliability was good with an intraclass correlation coefficient of 0.83 (95% CI, 0.74-0.89), SEM was 2.3 and SDC 6.5. CONCLUSIONS: The Norwegian version of the MSK-HQ demonstrated high internal consistency, a three-factor structure, good construct validity and good test-retest reliability when used among people on sick leave due to musculoskeletal disorders.

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.

Cost-utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study).

OBJECTIVE: To evaluate the cost-utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study. DESIGN: A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial. SETTING: Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect. PARTICIPANTS: 180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91). INTERVENTIONS: Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days. MAIN OUTCOME MEASURES: Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER). RESULTS: Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; -3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%. CONCLUSIONS: Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02323412.

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).

Back beliefs among elderly seeking health care due to back pain; psychometric properties of the Norwegian version of the back beliefs questionnaire.

BACKGROUND: The Back Beliefs Questionnaire (BBQ) is a 14-item patient-reported questionnaire that measures attitudes and beliefs about the consequences of back pain. The BBQ has recently been translated into Norwegian, but its psychometric properties have not yet been tested. The aim of this study is to evaluate the reliability and construct validity of the BBQ when used on elderly patients with back pain. METHOD: A prospective cohort study with a test-retest design among 116 elderly patients (> 55 years of age) seeking primary care for a new episode of back pain. Test-retest, standard error of measurement (SEM), minimal detectable change (MDC), internal consistency and construct validity by a priori hypotheses (Spearman's- and Pearson correlation coefficient) were tested. RESULTS: A total of 116 patients, mean age (SD) 67.7 (8.3), were included and 63 patients responded to the test-retest assessment. The mean (SD) BBQ sum scores (range 9-45) were 29.8 (7.0) and 29.2 (6.7) for the test and retest respectively. The test-retest was acceptable with an intraclass correlation coefficient of 0.71 (95% CI, 0.54-0.82), SEM was 3.8 and MDC 10.5. Internal consistency with Cronbach's alpha was good (0.82) and acceptable construct validity was supported by the confirmation of 75% of the a priori hypotheses. CONCLUSION: The Norwegian version of the BBQ demonstrated acceptable test-retest reliability and good construct validity and can be used to assess pessimistic beliefs in elderly patients with back pain.