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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. 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. 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. 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. 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. ISRCTN 94074203; https://www.isrctn.com/ISRCTN94074203. RR2-10.1186/s12891-020-3174-z.

ObjectiveTo assess the costs and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy among patients with sciatica.MethodsThis economic evaluation was conducted alongside a 12-month multicentre randomised controlled trial with a non-inferiority design, in which patients were randomised to PTED or open microdiscectomy. Patients were aged from 18 to 70 years and had at least 6 weeks of radiating leg pain caused by lumbar disc herniation. Effect measures included leg pain and quality-adjusted life years (QALYs), as derived using the EQ-5D-5L. Costs were measured from a societal perspective. Missing data were multiply imputed, bootstrapping was used to estimate statistical uncertainty, and various sensitivity analyses were conducted to determine the robustness.ResultsOf the 613 patients enrolled, 304 were randomised to PTED and 309 to open microdiscectomy. Statistically significant differences in leg pain and QALYs were found in favour of PTED at 12 months follow-up (leg pain: 6.9; 95% CI 1.3 to 12.6; QALYs: 0.040; 95% CI 0.007 to 0.074). Surgery costs were higher for PTED than for open microdiscectomy (ie, €4500/patient vs €4095/patient). All other disaggregate costs as well as total societal costs were lower for PTED than for open microdiscectomy. Cost-effectiveness acceptability curves indicated that the probability of PTED being less costly and more effective (ie, dominant) compared with open microdiscectomy was 99.4% for leg pain and 99.2% for QALYs.ConclusionsOur results suggest that PTED is more cost-effective from the societal perspective compared with open microdiscectomy for patients with sciatica.Trial registration number NCT02602093.

Background Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial. Methods WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher’s exact test. Discussion The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial. Trial registration WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.

Information on the pregnancy rate after successive in-vitro fertilization (IVF) cycles and their associated costs is relevant for couples undergoing assisted reproduction treatments (ARTs). This study, therefore, sought to investigate the effectiveness and the cost-effectiveness of two ARTs, the minimal ovarian stimulation IVF (MS-IVF) compared to the conventional ovarian stimulation IVF (C-IVF) from the payer's perspective. A 10-months follow-up prospective observational study was conducted in a sample of couples who sought ARTs in a private clinic in Southern Brazil. Women had to satisfy the Bologna Criteria and be older than 35 years. The effect outcome was pregnancy rate per initiated cycle. Medication costs were based on medical records. Costs and effect differences were estimated using seemingly unrelated regressions adjusted for the propensity score estimated based on women's characteristics. All 84 eligible women who agreed to participate received a total of 92 IVF cycles (MS-IVF, n=27[35 cycles]; C-IVF n=57[57 cycles]. The effect difference between MS-IVF and C-IVF was -5.1% (95%CI, -13.2 to 5.2). Medication costs of MS-IVF were significantly lower than C-IVF by €-1260 (95%CI, -1401 to -1118). The probabilities of MS-IVF being cost-effective compared to C-IVF ranged from 1 to 0.76 for willingness-to-pay of €0 to €15,000 per established pregnancy, respectively. Even though there were no positive effect differences between groups, MS-IVF might be cost-effective compared to C-IVF from the payer's perspective due to its relatively large cost savings compared to C-IVF. However, further investigation is needed to confirm these findings in a larger sample.

Background Blended physiotherapy, in which physiotherapy sessions and an online application are integrated, might support patients in taking an active role in the management of their chronic condition and may reduce disease related costs. The aim of this study was to evaluate the cost-effectiveness of a blended physiotherapy intervention (e-Exercise) compared to usual physiotherapy in patients with osteoarthritis of hip and/or knee, from the societal as well as the healthcare perspective. Methods This economic evaluation was conducted alongside a 12-month cluster randomized controlled trial, in which 108 patients received e-Exercise, consisting of physiotherapy sessions and a web-application, and 99 patients received usual physiotherapy. Clinical outcome measures were quality-adjusted life years (QALYs) according to the EuroQol (EQ-5D-3 L), physical functioning (HOOS/KOOS) and physical activity (Actigraph Accelerometer). Costs were measured using self-reported questionnaires. Missing data were multiply imputed and bootstrapping was used to estimate statistical uncertainty. Results Intervention costs and medication costs were significantly lower in e-Exercise compared to usual physiotherapy. Total societal costs and total healthcare costs did not significantly differ between groups. No significant differences in effectiveness were found between groups. For physical functioning and physical activity, the maximum probability of e-Exercise being cost-effective compared to usual physiotherapy was moderate (< 0.82) from both perspectives. For QALYs, the probability of e-Exercise being cost-effective compared to usual physiotherapy was 0.68/0.84 at a willingness to pay of 10,000 Euro and 0.70/0.80 at a willingness to pay of 80,000 Euro per gained QALY, from respectively the societal and the healthcare perspective. Conclusions E-Exercise itself was significantly cheaper compared to usual physiotherapy in patients with hip and/or knee osteoarthritis, but not cost-effective from the societal- as well as healthcare perspective. The decision between both interventions can be based on the preferences of the patient and the physiotherapist. Trial registration NTR4224 (25 October 2013).

Background Baseline imbalances, skewed costs, the correlation between costs and effects, and missing data are statistical challenges that are often not adequately accounted for in the analysis of cost-effectiveness data. This study aims to illustrate the impact of accounting for these statistical challenges in trial-based economic evaluations. Methods Data from two trial-based economic evaluations, the REALISE and HypoAware studies, were used. In total, 14 full cost-effectiveness analyses were performed per study, in which the four statistical challenges in trial-based economic evaluations were taken into account step-by-step. Statistical approaches were compared in terms of the resulting cost and effect differences, ICERs, and probabilities of cost-effectiveness. Results In the REALISE study and HypoAware study, the ICER ranged from 636,744€/QALY and 90,989€/QALY when ignoring all statistical challenges to − 7502€/QALY and 46,592€/QALY when accounting for all statistical challenges, respectively. The probabilities of the intervention being cost-effective at 0€/ QALY gained were 0.67 and 0.59 when ignoring all statistical challenges, and 0.54 and 0.27 when all of the statistical challenges were taken into account for the REALISE study and HypoAware study, respectively. Conclusions Not accounting for baseline imbalances, skewed costs, correlated costs and effects, and missing data in trial-based economic evaluations may notably impact results. Therefore, when conducting trial-based economic evaluations, it is important to align the statistical approach with the identified statistical challenges in cost-effectiveness data. To facilitate researchers in handling statistical challenges in trial-based economic evaluations, software code is provided.

Background Fractures of lower extremities are common trauma-related injuries, and have major impact on patients' functional status. A frequently used Patient-Reported Outcome Measure (PROM) to evaluate patients’ functional status with lower extremity fractures is the Lower Extremity Functional Scale (LEFS). However, there is no systematic review regarding content validity and other measurement properties of the LEFS in patients with lower extremity fractures. Methods A search was performed in PubMed, Embase, Scopus, and Cochrane Library from inception until November 2020. Studies on development of the LEFS and/or the evaluation of one or more measurement properties of the LEFS in patients with lower extremity fractures were included, and independently assessed by two reviewers using COSMIN guidelines. Results Seven studies were included. Content validity of the LEFS was rated 'inconsistent', supported by very low quality of evidence. Structural validity was rated ‘insufficient’ supported by doubtful methodological quality. Internal consistency, measurement error, and responsiveness were rated 'indeterminate' supported by inadequate to adequate methodological quality. The methodological quality of the construct validity (hypotheses testing) assessment was rated as 'inadequate'. Conclusion The LEFS has several shortcomings, the lack of sufficient content validity being the most important one as content validity is considered the most crucial measurement property of a PROM according to the COSMIN guidelines. In interpreting the outcomes, one should therefore be aware that not all relevant aspects of physical functioning may be accounted for in the LEFS. Further validation in a well-designed content validity study is needed, including a clearly defined construct and patient involvement during the assessment of different aspects of content validity. Plain English summary Bone fractures of the lower extremities are a common injury. During rehabilitation it is essential to evaluate how patients experience their physical functioning, in order to monitor the progress and to optimize treatment. To measure physical functioning often questionnaires (also known as Patient Reported Outcome Measures) are used, such as the Lower Extremity Functional Scale (LEFS). However, it is not clear if the LEFS actually measures physical function, and if its other measurement properties are sufficient for using this questionnaire among patients with fractures in the lower extremities. Therefore, we systematically searched and assessed scientific papers on the development of the LEFS (i.e., its ability to measure physical functioning), and papers on the performance of the LEFS with regard to several measurement properties to identify possible factors that may cause measurement errors. Hereby we have assessed the quality of the studies included. Our main finding was that the LEFS may not measure all aspects of physical function. Given the low quality of the papers included in our study, these findings come with considerable uncertainty. As the LEFS was developed more than 20 years ago, it may not represent physical functioning as we currently conceptualize this. Therefore, we recommend to perform a study in which the content of the LEFS will be evaluated by experts in the field as well as patients, and modify the questionnaire as needed.

Worldwide, work-related injury and disease form a major challenge to employers, workers’ unions, governments, and most importantly workers themselves. To combat this, a broad range of occupational health interventions has been developed that are typically aimed at preventing work-related illnesses and disease, and/or improving return-to-work after sickness absence or work disability (1). As resources are restricted, however, decision-makers increasingly call upon advisors and researchers to demonstrate that occupational health interventions are not only effective but also efficient in terms of their resource implications (2). For instance, a qualitative assessment among decision-makers in the Ontario healthcare sector showed that financial information – mostly in the form of a business case – can be a key deciding factor of whether to go forward with implementation of an intervention or occupational health service (3). In the past decades, various economic studies have been performed in the area of occupational health. These studies can be roughly divided into: (i) studies assessing the cost of ill health among workers and (ii) economic evaluations of interventions (1). Economic evaluations typically assess the cost-effectiveness and/or return-on-investment of occupational health interventions by comparing their incremental costs to their additional effects expressed in terms of physical units and monetary values, respectively. In recent years, various examples of such studies have been published in The Scandinavian Journal of Work, Environment & Health. Russo et al (4), for example, reported on the development of a cost-estimation method for work-related stress, while Finnes et al (5) assessed the long-term cost-effectiveness of return-to-work interventions for mental disorder-related absence. In another example, Lutz et al (6) summarized and critically appraised the health economic evidence on worksite physical activity and/or nutrition programs. Despite these good examples, the methodological quality of many economic evaluations in occupational health is far from optimal (6–8). To illustrate, many economic evaluations used a wide variety of – sometimes invalid – methods for estimating productivity-related costs, few economic evaluations validly assessed and/or reported on the uncertainty surrounding their results, and the follow-up duration of many economic evaluations is relatively short (6–8). Even though various efforts have been made to improve the methodological quality of economic evaluations in occupational health [eg, (2)], three issues still warrant specific attention: (i) measurement and valuation of productivity-related costs, (ii) analysis of trial-based economic evaluations, and (iii) use of modelling techniques. In the following, we will discuss these issues in greater detail and give pointers on where occupational health can benefit from cooperating with other research fields. Challenges for economic evaluations in occupational health Productivity-related costs are often the central point of focus in both cost of illness studies and economic evaluations in occupation health. This is because the impact of (work-related) injury and disease on productivity-related costs is substantial (9). Hassard et al (10), for example, found that productivity-related costs accounted for 70–90% of the total societal cost of work-related stress. Unfortunately, however, measuring and valuing productivity losses is complex and is likely even further complicated by the broad range of methods available for doing so. To illustrate, sickness absence can be measured objectively using company records or subjectively using a broad range of self-reported questionnaires (e.g. WHO-HPQ, PRODISQ). To complicate matters even further, sickness absence days can be valued using various methodological approaches (eg, the human capital or friction cost approaches) and different kinds of unit prices (eg, actual wage rates, average income) (2, 9). Reduced productivity while being at work (ie, presenteeism), on the other hand, is typically measured using simple numeric rating scales and can again be valued using a wide variety of approaches and unit prices. Consequently, economic evaluations in occupational health are highly heterogeneous in terms of their productivity-related cost estimation methods and large differences exist across studies in terms of the validity and transparent reporting of applied methods (9). We therefore agree with other authors that guidelines should be developed for measuring and valuing productivity-related costs (9). These guidelines should be specific to the field of occupational health and ideally consider cross-country differences. This is important because methods that are appropriate for a certain economic perspective and/or country are not necessarily appropriate for other perspectives and/or countries. In the Netherlands, for example, the “Dutch manual for costing studies in healthcare” recommends to only include productivity losses that occur during the period employers need to replace a sick worker (ie, friction cost approach) (11), whereas – in practice – Dutch employers are obliged to pay ≥70% of their sick workers’ wages for the duration of two years. Hence, it is questionable whether the recommended friction cost approach is appropriate from the company perspective as well. Additionally, we would like to encourage future studies to assess the appropriateness of the simple numeric rating scales that are currently being used for estimating presenteeism costs, and/or whether presenteeism cost estimates are preferably based on more detailed and validated productivity questionnaires, such as the “Individual Work Performance Questionnaire” (12). If the latter is the case, research is needed to assess how to validly convert workers’ responses to such questionnaires into monetary values. Ideally, this is done using objective information on productivity outputs, for instance by systematic worksite observations (13). The statistical quality of many economic evaluations in occupational health is poor (9, 14). Amongst others, baseline imbalances, the skewed nature of cost data, and the clustering of data are often neglected. On top of that, missing data are frequently handled using inappropriate methods, such as a complete-case analysis, and some studies do not even report on the uncertainty surrounding their cost-effectiveness and/or return-on-investment estimates (8). Inappropriate statistical methods, however, can lead to incorrect results and/or conclusions, and hence a sub-optimal allocation of available occupational health resources (9, 14). Improving the statistical quality of economic evaluations in occupational health starts with the development of recommendations on how to analyze them appropriately, accompanied by the publication of tutorial papers and annotated software codes. Also, as extensive progress has been made concerning the statistical analysis of economic evaluations in other research fields [eg, (14–16)], the quality of economic evaluations in occupational health will also benefit from an increased collaboration with health economists, biostatisticians, and/or econometricians. In the present issue, Finnes et al (5) provide a good example of such a collaboration, which in turn resulted in a state-of-the-art economic evaluation from the occupational health as well as economic perspective. Most economic evaluations in occupational health are solely based on worker-level data (6–8). Possible limitations of such an approach are that worker-level data are typically only available for a restricted number of workers, relatively short follow-up durations, and a limited number of comparators. To deal with these issues, researchers could make use of analytic modelling where economic evaluations are conducted by synthesizing information from multiple sources (eg, using Markov models) (2). Analytic modelling might, for example, be used to extrapolate economic evaluation results beyond the follow-up of a trial. This may be particularly informative for occupational health interventions that are expected to impact costs and/or effects for an extensive period of time (eg, worksite health promotion programs). Analytic modelling might also be used when researchers want to compare a number of interventions and/or when they are confronted with a large number of uncertain variables. Mofidi et al (17) recently provided a good example of analytic modelling in occupational health by assessing the cost-effectiveness of seven different combinations of silica exposure reduction interventions, while simultaneously assessing the robustness of the study results to a broad range of uncertain factors. Again, as extensive progress concerning analytic modelling has taken place in other research fields [eg, (18)], occupational health researchers aiming to use such techniques will likely benefit from collaborating with other research fields. What to do next? Economic evaluations in occupational health are confronted with various scientific challenges that need to be addressed to improve their scientific rigor, and hence the validity of their results and conclusions. To tackle some of these challenges, we encourage researchers to develop guidance and recommendations concerning the measurement and valuation of productivity-related costs as well as the statistical analysis of economic evaluations and to increasingly collaborate with researchers from other fields (eg, when aiming to use analytic modelling techniques). References 1. Burdorf A. Economic evaluation in occupational health-its goals, challenges, and opportunities. Scand J Work Environ Health 2007;33(3):161-4. https://doi.org/10.5271/sjweh.1127 2. van Dongen JM, van Wier MF, Tompa E, Bongers PM, van der Beek AJ, van Tulder MW, et al. Trial-based economic evaluations in occupational health: principles, methods, and recommendations. J Occup Environ Med 2014;56(6

IntroductionType 2 diabetes mellitus (T2DM) is a major burden on public health worldwide. To reduce adverse events and complications, effective T2DM self-management is required. Self-management and glycaemic control are generally poorer in lower educated people compared with higher educated people. This study aims to assess the (cost-)effectiveness and to conduct a process evaluation of a diabetes self-management programme, ‘Powerful Together With Diabetes’ (PTWD), which is specifically developed for patients from lower educational groups.Methods and analysisThe PTWD programme is focused on attaining basic knowledge and skills for effective diabetes self-management. In a previous study (the Diabetes in Social Context (DISC) study), lower-educated participants enjoyed the PTWD programme as well as improved their T2DM-related behaviours. The design of the study is an effectiveness-implementation hybrid type 2 trial. We will conduct mixed methods effectiveness, process and economic evaluations. To investigate the (cost-)effectiveness, a two-arm quasi-experimental trial will be conducted with a parallel mixed method process evaluation. The primary outcome of the study is change in haemoglobin A1c levels from baseline to 12 months. Secondary outcomes include use of primary and secondary care, medication use, blood biomarkers, T2DM self-management health behaviours, anthropometrics, and quality of life. Data will be collected with questionnaires, physical activity trackers and registration data from general practitioner registries. To see if the results are maintained, we will also measure the outcomes 24 months after baseline. Study participants are patients from lower educational groups living with T2DM between 35 and 70 years old. Participants will be recruited through general practices, and the intervention will be held in community centres. Our aim is to include 114 participants in the intervention group and 570 participants in the control group.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the Academic Medical Center in Amsterdam (#2021_222). Participants will sign an informed consent form prior to enrolment. Manuscripts with the results of the effectiveness, economic and process evaluations will be published in peer-reviewed journals.Trial registration numberISRCTN12982302 ISRCTN registry (registered on 29 March 2022).

Background Chronic non-specific low back pain (CNLBP) is a prevalent and costly condition that encourages research into self-management strategies. Mobile health (mhealth) applications are promising interventions, but current evidence on their effectiveness is still conflicting. The aim is to investigate the (cost-)effectiveness of a supervised and personalized mhealth intervention, compared with conventional exercise therapy in individuals with CNLBP. Methods A multicentre trial-based economic evaluation was designed to compare a mhealth intervention with conventional exercise. Participants will be recruited from two physical therapy rehabilitation clinics located within the participating centres. Adults aged between 18 and 59 years and with self-reported LBP > 12 weeks will be included. Following the collection of baseline data, participants will be randomly assigned to one of two groups using a permuted block randomization: (1) mhealth; (2) Conventional exercise delivered through a booklet. Outcome assessments will be conducted following randomisation at five distinct time points, resulting in a total follow-up period of 12 months. The primary clinical outcome is disability (Roland-Morris Disability Questionnaire), while secondary outcomes include pain (NRS), utility (Eq. 5D5L), fears and beliefs (FABQ), self-efficacy (PSEQ), and global perceived effect. A sample size of 146 participants was estimated (73 allocated to each group) to detect a 2-point between-groups difference on disability. A cost-effectiveness study will be conducted alongside the trial, comparing the two interventions in terms of costs and clinical outcomes. Discussion While mhealth applications show promise as interventions for people with LBP, there is still a gap regarding the type of delivery and personalisation strategies. This study investigates whether the implementation of stratified and tailored care within a mobile application, based on patient-reported outcome measures and supervised by a physiotherapist, is (cost-)effective. Trial registration: NCT06651099 (registration date 21/10/2024).