Cost-effectiveness of strength exercise or aerobic exercise compared with usual care for patients with knee osteoarthritis: secondary results from a multiarm randomised controlled trial in Norway.

OBJECTIVES: To evaluate the 1-year cost-effectiveness of strength exercise or aerobic exercise compared with usual care for patients with symptomatic knee osteoarthritis (OA), from a societal and healthcare perspective. DESIGN: Cost-effectiveness analysis embedded in a three-arm randomised controlled trial. PARTICIPANTS AND SETTING: A total of 161 people with symptomatic knee OA seeking Norwegian primary or secondary care were included in the analyses. INTERVENTIONS: Participants were randomised to either 12 weeks of strength exercise (n=54), 12 weeks of aerobic exercise (n=53) or usual care (n=54). OUTCOME MEASURES: Quality-adjusted life-years (QALYs) estimated by the EuroQol-5 Dimensions-5 Levels, and costs related to healthcare utilisation and productivity loss estimated in euros (€), aggregated for 1 year of follow-up. Cost-effectiveness was expressed with mean incremental cost-effectiveness ratios (ICERs). Bootstrapping was used to estimate ICER uncertainty. RESULTS: From a 1-year societal perspective, the mean cost per patient was €7954, €8101 and €17 398 in the strength exercise, aerobic exercise and usual care group, respectively. From a 1-year healthcare perspective, the mean cost per patient was €848, €2003 and €1654 in the strength exercise, aerobic exercise and usual care group, respectively. Mean differences in costs significantly favoured strength exercise and aerobic exercise from a 1-year societal perspective and strength exercise from a 1-year healthcare perspective. There were no significant differences in mean QALYs between groups. From a 1-year societal perspective, at a willingness-to-pay threshold of €27 500, the probability of strength exercise or aerobic exercise being cost-effective was ≥98%. From a 1-year healthcare perspective, the probability of strength exercise or aerobic exercise being cost-effective was ≥97% and ≥76%, respectively. CONCLUSION: From a 1-year societal and healthcare perspective, a 12-week strength exercise or aerobic exercise programme is cost-effective compared with usual care in patients with symptomatic knee OA. TRIAL REGISTRATION NUMBER: NCT01682980.

Cost-effectiveness of Transforaminal epidural steroid injections for patients with ACUTE sciatica: a randomized controlled trial.

BACKGROUND: Transforaminal epidural injections with steroids (TESI) are increasingly being used in patients sciatica. The STAR (steroids against radiculopathy)-trial aimed to evaluate the (cost-) effectiveness of TESI in patients with acute sciatica (< 8 weeks). This article contains the economic evaluation of the STAR-trial. METHODS: Participants were randomized to one of three study arms: Usual Care (UC), that is oral pain medication with or without physiotherapy, n = 45); intervention group 1: UC and transforaminal epidural steroid injection (TESI) 1 ml of 0.5% Levobupivacaine and 1 ml of 40 mg/ml Methylprednisolone and intervention group 2: UC and transforaminal epidural injection (TEI) with 1 ml of 0,5% Levobupivacaine and 1 ml of 0.9% NaCl (n = 50). The primary effect measure was health-related quality of life. Secondary outcomes were pain, functioning, and recovery. Costs were measured from a societal perspective, meaning that all costs were included, irrespective of who paid or benefited. Missing data were imputed using multiple imputation, and bootstrapping was used to estimate statistical uncertainty. RESULTS: None of the between-group differences in effects were statistically significant for any of the outcomes (QALY, back pain, leg pain, functioning, and global perceived effect) at the 26-weeks follow-up. The adjusted mean difference in total societal costs was €1718 (95% confidence interval [CI]: - 3020 to 6052) for comparison 1 (intervention group 1 versus usual care), €1640 (95%CI: - 3354 to 6106) for comparison 2 (intervention group 1 versus intervention group 2), and €770 (95%CI: - 3758 to 5702) for comparison 3 (intervention group 2 versus usual care). Except for the intervention costs, none of the aggregate and disaggregate cost differences were statistically significant. The maximum probability of all interventions being cost-effective compared to the control was low (< 0.7) for all effect measures. CONCLUSION: These results suggest that adding TESI (or TEI) to usual care is not cost-effective compared to usual care in patients with acute sciatica (< 8 weeks) from a societal perspective in a Dutch healthcare setting. TRIAL REGISTRATION: Dutch National trial register: NTR4457 (March, 6th, 2014).

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).

Mapping Oswestry Disability Index Responses to EQ-5D-3L Utility Values: Are Cost-Utility Results Valid?

OBJECTIVES: To develop and validate approaches for mapping Oswestry Disability Index responses to 3-level version of EQ-5D utility values and to evaluate the impact of using mapped utility values on cost-utility results compared with published regression models. METHODS: Three response mapping approaches were developed in a random sample of 70% of 18 692 patients with low back pain: nonparametric approach (Non-p), nonparametric approach excluding logical inconsistencies (Non-peLI), and ordinal logistic regression (OLR). Performance was assessed in the remaining 30% using R-square (R2), root mean square error (RMSE), and mean absolute error (MAE). To evaluate whether MAEs and their 95% limits of agreement (LA) were clinically relevant, a minimally clinically important difference of 0.074 was used. Probabilities of cost-effectiveness estimated using observed and mapped utility values were compared in 2 economic evaluations. RESULTS: The Non-p performed the best (R2 = 0.43; RMSE = 0.22; MAE = 0.03; 95% LA = -0.40 to 0.47) compared with the Non-peLI (R2 = 0.07; RMSE = 0.29; MAE = -0.15; 95% LA = -0.63 to 0.34) and OLR (R2 = 0.22; RMSE = 0.26; MAE = 0.02; 95% LA = -0.49 to 0.53). MAEs were lower than the minimally clinically important difference for the Non-p and OLR but not for the Non-peLI. Differences in probabilities of cost-effectiveness ranged from 1% to 4% (Non-p), 0.1% to 9% (Non-peLI), and 0.1% to 20% (OLR). CONCLUSIONS: Results suggest that the developed response mapping approaches are not valid for estimating individual patients' 3-level version of EQ-5D utility values, and-depending on the approach-may considerably affect cost-utility results. The developed approaches did not perform better than previously published regression-based models and are therefore not recommended for use in economic evaluations.

Can EQ-5D-3L utility values of low back pain patients be validly predicted by the Oswestry Disability Index for use in cost-effectiveness analyses?

PURPOSE: To assess whether regression modeling can be used to predict EQ-5D-3L utility values from the Oswestry Disability Index (ODI) in low back pain (LBP) patients for use in cost-effectiveness analysis. METHODS: EQ-5D-3L utility values of LBP patients were estimated using their ODI scores as independent variables using regression analyses, while adjusting for case-mix variables. Six different models were estimated: (1) Ordinary Least Squares (OLS) regression, with total ODI score, (2) OLS, with ODI item scores as continuous variables, (3) OLS, with ODI item scores as ordinal variables, (4) Tobit model, with total ODI score, (5) Tobit model, with ODI item scores as continuous variables, and (6) Tobit model, with ODI item scores as ordinal variables. The models' performance was assessed using explained variance (R2) and root mean squared error (RMSE). The potential impact of using predicted instead of observed EQ-5D-3L utility values on cost-effectiveness outcomes was evaluated in two empirical cost-effectiveness analysis. RESULTS: Complete individual patient data of 18,692 low back pain patients were analyzed. All models had a more or less similar R2 (range 45-52%) and RMSE (range 0.21-0.22). The two best performing models produced similar probabilities of cost-effectiveness for a range of willingness-to-pay (WTP) values compared to those based on the observed EQ-5D-3L values. For example, the difference in probabilities ranged from 2 to 5% at a WTP of 50,000 €/QALY gained. CONCLUSION: Results suggest that the ODI can be validly used to predict low back pain patients' EQ-5D-3L utility values and QALYs for use in cost-effectiveness analyses.

Cost-Effectiveness of Radiofrequency Denervation for Patients With Chronic Low Back Pain: The MINT Randomized Clinical Trials.

OBJECTIVES: To evaluate the cost-effectiveness of radiofrequency denervation when added to a standardized exercise program for patients with chronic low back pain. METHODS: An economic evaluation was conducted alongside 3 pragmatic multicenter, nonblinded randomized clinical trials (RCTs) in The Netherlands with a follow up of 52 weeks. Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain; a positive diagnostic block at the facet joints (n = 251), sacroiliac (SI) joints (n = 228), or a combination of facet joints, SI joints, and intervertebral discs (n = 202); and were unresponsive to initial conservative care. Quality-adjusted life-years (QALYs) and societal costs were measured using self-reported questionnaires. Missing data were imputed using multiple imputation. Bootstrapping was used to estimate statistical uncertainty. RESULTS: After 52 weeks, no difference in costs between groups was found in the facet joint or combination RCT. The total costs were significantly higher for the intervention group in the SI joint RCT. The maximum probability of radiofrequency denervation being cost-effective when added to a standardized exercise program ranged from 0.10 in the facet joint RCT to 0.17 in the SI joint RCT irrespective of the ceiling ratio, and 0.65 at a ceiling ratio of €30 000 per QALY in the combination RCT. CONCLUSIONS: Although equivocal among patients with symptoms in a combination of the facet joints, SI joints, and intervertebral discs, evidence suggests that radiofrequency denervation combined with a standardized exercise program cannot be considered cost-effective from a societal perspective for patients with chronic low back pain originating from either facet or SI joints in a Dutch healthcare setting.

Time to return to work following workplace violence among direct healthcare and social workers.

OBJECTIVES: This study examined time to return-to-work (RTW) among direct healthcare and social workers with violence-related incidents compared with these workers with non-violence-related incidents in British Columbia, Canada. METHODS: Accepted workers' compensation lost-time claims were extracted between 2010 and 2014. Workers with violence-related incidents and with non-violence-related incidents were matched using coarsened exact matching (n=5762). The outcome was days until RTW within 1 year after the first day of time loss, estimated with Cox regression using piecewise models, stratified by injury type, occupation, care setting and shift type. RESULTS: Workers with violence-related incidents, compared with workers with non-violence-related incidents, were more likely to RTW within 30 days postinjury, less likely within 61-180 days, and were no different after 181 days. Workers with psychological injuries resulting from a violence-related incident had a lower likelihood to RTW during the year postinjury (HR 0.61, 95% CI 0.43 to 0.86). Workers with violence-related incidents in counselling and social work occupations were less likely to RTW within 90 days postinjury (HR 31-60 days: 0.67, 95% CI 0.48 to 0.95 and HR 61-90 days: 0.46, 95% CI 0.30 to 0.69). Workers with violence-related incidents in long-term care and residential social services were less likely to RTW within 91-180 days postinjury. CONCLUSIONS: Workers with psychological injuries, and those in counselling and social work occupations and in long-term care and residential social services, took longer to RTW following a violence-related incident than workers with non-violence-related incidents. Future research should focus on identifying risk factors to reduce the burden of violence and facilitate RTW.

Descriptive Epidemiology of Gradual Return to Work for Workers With a Work-Acquired Musculoskeletal Disorder in British Columbia, Canada.

OBJECTIVE: This study investigates the injury, socio-demographic, workplace, and temporal characteristics related with gradual return to work (RTW) among workers with a work-acquired musculoskeletal disorder in British Columbia, Canada. METHODS: Accepted workers' compensation lost-time claims were extracted between 2010 and 2015 (n = 141,490). A multivariable logistic regression model was used to analyze the determinants of Gradual RTW. RESULTS: Within 1 year after injury, 41.0% of workers had at least 1 day of Gradual RTW. Serious injury severity, female sex, increasing age, wage, and firm size, longer sickness absence, and recent previous claims increased the proportion of workers being provided with Gradual RTW. CONCLUSION: Consideration of injury, socio-demographic, workplace, and temporal variability in the provision of Gradual RTW can identify inequalities in the provision and increase effective use of Gradual RTW for workers with musculoskeletal disorders.

Predictive factors of high societal costs among chronic low back pain patients.

BACKGROUND: Societal costs of low back pain (LBP) are high, yet few studies have been performed to identify the predictive factors of high societal costs among chronic LBP patients. This study aimed to determine which factors predict high societal costs in patients with chronic LBP. METHODS: Data of 6,316 chronic LBP patients were used. In the main analysis, high societal costs were defined as patients in the top 10% of cost outcomes. Sensitivity analyses were conducted using patients in the top 5% and top 20% of societal costs. Potential predictive factors included patient expectations, demographic factors (e.g. age, gender, nationality), socio-economic factors (e.g. employment, education level) and health-related factors (e.g. body mass index [BMI], general health, mental health). The final prediction models were obtained using backward selection. The model's prognostic accuracy (Hosmer-Lemeshow X2 , Nagelkerke's R2 ) and discriminative ability (area under the receiver operating curve [AUC]) were assessed, and the models were internally validated using bootstrapping. RESULTS: Poor physical health, high functional disability, low health-related quality of life, high impact of pain experience, non-Dutch nationality and decreasing pain were found to be predictive of high societal costs in all models, and were therefore considered robust. After internal validation, the models' fit was good, their explained variance was relatively low (≤14.1%) and their AUCs could be interpreted as moderate (≥0.71). CONCLUSION: Future studies should focus on understanding the mechanisms associated with the identified predictors for high societal costs in order to design effective cost reduction initiatives. SIGNIFICANCE: Identifying low back pain patients who are at risk (risk stratification) of becoming high-cost users and making appropriate initiatives could help in reducing high costs.

Return-to-work for multiple jobholders with a work-related musculoskeletal disorder: A population-based, matched cohort in British Columbia.

INTRODUCTION: Multiple jobholders (MJHs) have a higher risk of injury compared to single jobholders (SJHs), but it is unknown if return-to-work (RTW) after a work injury is affected by multiple jobholding. This study examined the association between multiple versus single jobholding and time to RTW for workers with a work-related musculoskeletal disorder (MSD). METHODS: We used administrative workers' compensation data to identify injured workers with an accepted MSD lost-time claim between 2010-2014 in British Columbia, Canada (n = 125,639 SJHs and 9,029 MJHs). The outcome was days until RTW during twelve months after the first day of time-loss. The MJH and SJH cohorts were balanced using coarsened exact matching that yielded a final matched cohort of 8,389 MJHs and 8,389 SJHs. The outcome was estimated with Cox regression, using piecewise models, and the hazard ratios were stratified by type of MSD, a serious injury indicator, gender, weekly workdays preceding MSD, and wage categories. RESULTS: MJHs were less likely to RTW compared to SJHs within the first six months after the first time-loss day, with greater and longer lasting effects for males, workers with a serious injury, and a higher wage. No difference between MJHs and SJHs was found for workers who had a six- or seven-day work week preceding MSD, for workers with dislocations, and for workers who were still off work after six months. CONCLUSIONS: Overall, MJHs with a workweek of maximum five days are disadvantaged compared to SJHs in terms of RTW following a work-related MSD within the first six months after the first time-loss day. This difference might be caused by more precarious job contracts for MJHs that challenges RTW because of lack of support for modified work, higher workload, and reduced likelihood that MJHs file a workers' compensation claim. Despite adjusting for type of MSD, severity of injury and occupation, the differences persisted for the vast majority of the study sample.

Identifying return-to-work trajectories using sequence analysis in a cohort of workers with work-related musculoskeletal disorders.

Objectives This study aimed to identify return-to-work (RTW) trajectories among workers with work-related musculoskeletal disorders (MSD) and examine the associations between different MSD and these RTW trajectories. Methods We used administrative workers' compensation data to identify accepted MSD lost-time claims with an injury date between 2010-2012 in British Columbia, Canada. Cox regression analyses were used to investigate differences in time to RTW between MSD. Validated day-to-day calendar measures of four RTW states (sickness absence, modified RTW, RTW, and non-RTW) were grouped into RTW trajectories spanning a one-year period using sequence analysis. RTW trajectories were clustered using decision rules that identified a shared trajectory structure. Poisson regression with robust standard errors was used to estimate relative risk ratios (RR) with 95% confidence intervals (CI) between MSD and RTW trajectory clusters. Results In a cohort of 81 062 claims, 2132 unique RTW trajectories were identified and clustered into nine RTW trajectory clusters. Half of the workers sustainably returned to work within one month. Workers with back strains were most likely to have trajectories characterized by early sustained RTW, while workers with fractures or dislocations were more likely to have prolonged sickness absence trajectories (RR 4.9-9.9) or non-RTW trajectories (RR 1.4-7.6). Conclusion This is the first study that has characterized different types of RTW trajectories of workers with MSD using sequence analysis. The application of sequence analysis and the identification of RTW trajectories yielded a number of key insights not found using conventional cox regression analysis.

Treatment of acute sciatica with transforaminal epidural corticosteroids and local anesthetic: design of a randomized controlled trial.

BACKGROUND: Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However there is much debate about their safety and effectiveness. It is important to identify patients that benefit most from TESI and only few trials have yet evaluated the effects in patients with acute sciatica. METHODS: We describe a prospective, randomized controlled trial (RCT), with the aim to evaluate the hypothesis that TESI plus Levobupivacaine (TESI-plus) added to oral pain medication is more effective compared to pain medication alone or compared to transforaminal injection with a local anesthetic of short duration among patients with acute sciatica. We will recruit a total of 264 patients with sciatica (<8 weeks) caused by a herniated disc, from two clinical sites. Participants are randomly assigned one of three study groups: 1) oral pain medication (control group), 2) oral pain medication and TESI-plus (intervention group one), 3) oral pain medication and transforaminal epidural injection (TEI) with Levobupivaine and saline solution (intervention group two). Primary outcomes are functional status (Roland-Morris Disability Questionnaire), pain intensity for both leg and back, (100 mm visual analogous scale (VAS)), and global perceived recovery (GPR, reported on a 7-point Likert scale, dichotomized into 'recovered' and 'not recovered'). The secondary outcomes are health-related quality of life (EQ5D-5 L) and patient satisfaction (7-point Likert scale). We will also collect information on healthcare utilization and costs, to perform an economic evaluation. All outcomes are measured at three and six weeks, three and six months after randomization. We defined a minimal clinically relevant difference between groups as a difference between both intervention groups and the control group of 20 points for pain (100-point VAS), four points for functional status (24-point RDQ) and a 20% difference on dichotomized GPR (recovered versus not recovered). DISCUSSION: A clinically relevant outcome in favor of TESI-plus implies that future patients with acute sciatica should be recommended TESI-plus within the first few weeks rather than being treated with pain medication alone in order to relieve pain and improve their functioning. In case of a negative result (no relevant differences in outcome between the three study arms), pain medication will remain the mainstay of treatment in the acute stages of sciatica. TRIAL REGISTRATION: Dutch National trial register: NTR4457 (March, 6th, 2014).

Cost-effectiveness of minimal interventional procedures for chronic mechanical low back pain: design of four randomised controlled trials with an economic evaluation.

BACKGROUND: Minimal interventional procedures are frequently applied in patients with mechanical low back pain which is defined as pain presumably resulting from single sources: facet, disc, sacroiliac joint or a combination of these. Usually, these minimal interventional procedures are an integral part of a multidisciplinary pain programme. A recent systematic review issued by the Dutch Health Insurance Council showed that the effectiveness of these procedures for the total group of patients with chronic low back pain is yet unclear and cost-effectiveness unknown. The aim of the study is to evaluate whether a multidisciplinary pain programme with minimal interventional procedures is cost-effective compared to the multidisciplinary pain programme alone for patients with chronic mechanical low back pain who did not respond to conservative primary care and were referred to a pain clinic. METHODS: All patients with chronic low back pain who are referred to one of the 13 participating pain clinics will be asked to participate in an observational study. Patients with a suspected diagnosis of facet, disc or sacroiliac joint problems will receive a diagnostic block to confirm this diagnosis. If confirmed, they will be asked to participate in a randomized controlled trial (RCT). For each single source a separate RCT will be conducted. Patients with a combination of facet, disc or sacroiliac joint problems will be invited for participation in a RCT as well. An economic evaluation from a societal perspective will be performed alongside these four RCTs. Patients will complete questionnaires at baseline, 3 and 6 weeks, 3, 6, 9 and 12 months after start of the treatment. Costs will be collected using self-completed cost questionnaires. DISCUSSION: No trials are yet available which have evaluated the cost-effectiveness of minimal interventional procedures in patients with chronic mechanical low back pain, which emphasizes the importance of this study. TRIAL REGISTRATION NUMBER: National Trial Register: NTR3531.