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Trial-based economic evaluations are increasingly being conducted to support healthcare decision-making. When analysing trial-based economic evaluation data, different methodological challenges may be encountered, including (i) missing data, (ii) correlated costs and effects, (iii) baseline imbalances and (iv) skewness of costs and/or effects. Despite the broad range of methods available to account for these methodological challenges in effectiveness studies, they may not always be directly applicable in trial-based economic evaluations where costs and effects are analysed jointly, and more than one methodological challenge typically needs to be addressed simultaneously. The use of inappropriate methods can bias results and conclusions regarding the cost-effectiveness of healthcare interventions. Eventually, such low-quality evidence can hamper healthcare decision-making, which may in turn result in a waste of already scarce healthcare resources. Therefore, this tutorial aims to provide step-by-step guidance on how to combine appropriate statistical methods for handling the abovementioned methodological challenges using a ready-to-use R script. The theoretical background of the described methods is provided, and their application is illustrated using a simulated trial-based economic evaluation. [ABSTRACT FROM AUTHOR]

To manage chronic pain, multidisciplinary interventions have been increasingly deployed, mostly in secondary or tertiary care settings. Evidence on the effectiveness of multidisciplinary intervention within primary care is scarce. This study examined the effectiveness of a primary care multidisciplinary treatment for chronic pain compared with treatment as usual (TAU). The intervention consisted of pain neuroscience education and treatment by a GP, psychologist, and physiotherapist. Both groups filled out patient-reported outcome measures at baseline, 6 months, and 12 months. The results indicated there were no statistically significant differences for the primary outcomes of pain intensity, number of pain sites, and health-related quality of life (HR-QoL). There was a statistically significant difference in the secondary outcome perceived health change in favor of the intervention group. None of the other differences were statistically significant. A post-hoc analysis showed that there were statistically significant effects on patients' illness perceptions in favor of the intervention group. Based on the results, the findings do not support effectiveness of a low intensity outpatient multidisciplinary primary care treatment to treat chronic pain compared with TAU. However, as a result of several study limitations, it is considered unwarranted to conclude that multidisciplinary treatment in primary care is not valuable at all. [ABSTRACT FROM AUTHOR]

Employers generally like to know if participatory ergonomic interventions are worth their money. We found that a participatory ergonomic intervention tended to be cost-effective and has the potential to gain monetary benefits in the childcare sector. Objectives: To evaluate the cost-effectiveness and return-on-investment (ROI) of 20-week ergonomic intervention to reduce physical exertion at work compared with usual-practice among childcare workers. Methods: One hundred ninety workers from 16 institutions were cluster-(institute)-randomized to intervention (n = 96) and usual-practice (n = 94) group. The intervention group participated in three workshops to develop/implement action plans improving ergonomic conditions. The rating of physical exertion (RPE) was measured at baseline and 20-weeks. Employer-perspective-based costs of intervention, absenteeism, and presenteeism were estimated. Results: Although statistically non-significant, one-unit reduction in RPE was associated with saving of 592 EUR/worker. Per-EUR invested by the employer was associated with 1.6 EUR (95% CI: –3.1; 6.5) return in the intervention compared with usual practice. Conclusion: The intervention tended to gain monetary benefit for the employer. The results should be replicated in larger populations for improved precision of economic evaluation estimates. Trial registration: ISRCTN10928313 [ABSTRACT FROM AUTHOR]

Background: Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis for the STAR trial that assesses the (cost-)effectiveness of TESI during the acute stage of sciatica (< 8 weeks).Methods: The STAR trial is a multicentre, randomized controlled, prospective trial (RCT) investigating the (cost-)effectiveness of TESI by making a three-group comparison among patients with acute sciatica due to a herniated lumbar disc (< 8 weeks): (1) TESI combined with levobupivacaine added to oral pain medication (intervention group 1) versus oral pain medication alone (control group), (2) intervention group 1 versus transforaminal epidural injection with levobupivacaine and saline solution added to oral pain medication (intervention group 2), and (3) intervention group 2 versus control group. Co-primary outcomes were physical functioning (Roland Morris Disability Questionnaire), pain intensity (10-point numerical rating scale), and global perceived recovery (7-point Likert scale, dichotomized into 'recovered' and 'not recovered'). For all three comparisons, we defined the following minimal clinically relevant between-group differences: two points for pain intensity (range 0-10), four points for physical functioning (range 0-24) and a 20% difference in recovery rate. Secondary outcomes are health-related quality of life (EQ-5D-5L) and patient satisfaction (7-point Likert scale) and surgery rate. We also collected resource use data to perform an economic evaluation. Analyses will be conducted by intention-to-treat with p < 0.05 (two-tailed) for all three comparisons. Effects will be estimated using mixed models by maximum likelihood. For each comparison, mean differences, or difference in proportions, between groups will be tested per time point and an overall mean difference, or difference in proportions, between groups during the complete duration of follow-up (6 months) will be estimated. In the economic evaluation, Multivariate Imputation by Chained Equations will be used to handle missing data. Cost and effect differences will be estimated using seemingly unrelated regression, and uncertainty will be estimated using bootstrapping techniques.Discussion: This statistical analysis plan provides detailed information on the intended analysis of the STAR trial, which aims to deliver evidence about the (cost-)effectiveness of TESI during the acute phase of sciatica (< 8 weeks).Trial Registration: Dutch National trial register NTR4457 (6 March 2014). [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to assess the performance and impact of multilevel modelling (MLM) compared with ordinary least squares (OLS) regression in trial-based economic evaluations with clustered data. Methods: Three thousand datasets with balanced and unbalanced clusters were simulated with correlation coefficients between costs and effects of − 0.5, 0, and 0.5, and intraclass correlation coefficients (ICCs) varying between 0.05 and 0.30. Each scenario was analyzed using both MLM and OLS. Statistical uncertainty around MLM and OLS estimates was estimated using bootstrapping. Performance measures were estimated and compared between approaches, including bias, root mean squared error (RMSE) and coverage probability. Cost and effect differences, and their corresponding confidence intervals and standard errors, incremental cost-effectiveness ratios, incremental net-monetary benefits and cost-effectiveness acceptability curves were compared. Results: Cost-effectiveness outcomes were similar between OLS and MLM. MLM produced larger statistical uncertainty and coverage probabilities closer to nominal levels than OLS. The higher the ICC, the larger the effect on statistical uncertainty between MLM and OLS. Significant cost-effectiveness outcomes as estimated by OLS became non-significant when estimated by MLM. At all ICCs, MLM resulted in lower probabilities of cost effectiveness than OLS, and this difference became larger with increasing ICCs. Performance measures and cost-effectiveness outcomes were similar across scenarios with varying correlation coefficients between costs and effects. Conclusions: Although OLS produced similar cost-effectiveness outcomes, it substantially underestimated the amount of variation in the data compared with MLM. To prevent suboptimal conclusions and a possible waste of scarce resources, it is important to use MLM in trial-based economic evaluations when data are clustered. [ABSTRACT FROM AUTHOR]

Background: The Transmural Trauma Care Model (TTCM) is a refined post-clinical rehabilitation approach, in which a multidisciplinary hospital-based team guides a network of primary care physical therapists in the treatment of trauma patients. The objective of this study was to assess the effectiveness of the TTCM compared to regular care.Methods: A controlled-before-and-after study was performed in a level 1 trauma center. The TTCM includes four elements: 1) a multidisciplinary team at the outpatient clinic, 2) coordination and individual goal setting for each patient by this team, 3) a network of primary care physical therapists, 4) E-health support for transmural communication. Intervention group patients were prospectively followed (3, 6 and 9 months). The control group consisted of 4 clusters of patients who either had their first consultation at the outpatient clinic 0, 3, 6 or 9 months ago. Outcomes included generic- and disease-specific health-related quality of life (HR-QOL), pain, functional status, patient satisfaction, and perceived recovery. Between-group comparisons were made using linear regression analyses. The recovery pattern of intervention group patients was identified using longitudinal data analysis methods.Results: A total of 83 participants were included in the intervention group. In the control group, 202 participants were included (68 in the baseline cluster, 26 in the 3-month cluster, 51 in the 6-month cluster, 57 in the 9-month cluster). Between-group differences were statistically significant in favor of the intervention group for disease-specific HR-QOL at 9 months, pain at 6 and 9 months, functional status at 6 and 9 months, patient satisfaction at 3, 6 and 9 months, and perceived recovery at 6 months. No significant differences were found between groups for generic HR-QOL at any time point. Generic HR-QOL, disease-specific HR-QOL, pain, and functional status significantly improved in a linear fashion among intervention group patients during the nine-month follow-up period.Conclusions: This study provides preliminary evidence that the TTCM is effective in improving patient related outcome measures, such as disease-specific HR-QOL, pain and functional status. A multicenter, and ideally randomized controlled trial, is required to confirm these results.Trial Registration: The trial is registered at the Dutch Trial Register (NTR5474). Registered 12 October 2015. Retrospectively registered. [ABSTRACT FROM AUTHOR]

Information on healthcare utilization and costs of general practitioner (GP)--guided care in patients with musculoskeletal complaints is important for keeping healthcare affordable and accessible. A registry-based study was performed to describe healthcare utilization and costs of GP-guided care in patients with musculoskeletal complaints and to predict having higher direct healthcare costs. Healthcare costs of GP-guided care included all healthcare resources used by patients due to a musculoskeletal condition in 2018. Data were extracted from the database with a 1-year follow-up and descriptively analyzed. A general linear model was developed to predict having higher direct healthcare costs. In total, 403,719 patients were included, of whom 92% only received a single consultation. The number of referrals varied across the different types of complaints. Total annual direct healthcare costs amounted to €39,180,531, of which a key cost driver was referrals. Primary care consultations accounted for the largest part of referral-related costs. For all musculoskeletal conditions combined, the mean annual direct healthcare cost per patient was €97 (SEM 5 €0.18). Older age, being a woman, low socioeconomic status, spine complaints, high number of musculoskeletal diagnoses, and a high comorbidity score were predictive of having higher direct healthcare costs and explained 0.7% of the variance. This study showed that mean annual direct healthcare costs of GP-guided care in patients with musculoskeletal conditions were relatively low and did not differ considerably across conditions. The predictive model explained a negligible part of the variance in costs. Thus, it is unclear which factors do predict high direct healthcare costs in this population. [ABSTRACT FROM AUTHOR]

Introduction: Chronic Low Back Pain (CLBP) is a heterogeneous condition with lack of diagnostic clarity. Therapeutic interventions show small effects. To improve outcomes by targeting interventions it is recommended to develop a triage system to surgical and non-surgical treatments based on treatment outcomes. The objective of the current study was to develop and internally validate prognostic models based on pre-treatment patient-reported profiles that identify patients who either respond or do not respond to two frequently performed treatments (lumbar spine surgery and multidisciplinary pain management program). Methods: A consecutive cohort study in a secondary referral spine center was performed. The study followed the recommendations of the PROGRESS framework and was registered in the Dutch Trial Register (NTR5946). Data of forty-seven potential pre-consultation (baseline) indicators predicting ‘response’ or ‘non-response’ at one-year follow-up for the two treatments were obtained to develop and validate four multivariable logistic regression models. The source population consisted of 3,410 referred CLBP-patients. Two treatment cohorts were defined: elective ‘spine surgery’ (n = 217 [6.4%]) and multidisciplinary bio-psychosocial ‘pain management program’ (n = 171 [5.0%]). Main inclusion criteria were age ≥18, CLBP (≥6 months), and not responding to primary care treatment. The primary outcome was functional ability: ‘response’ (Oswestry Disability Index [ODI] ≤22) and ‘non-response’ (ODI ≥41). Results: Baseline indicators predictive of treatment outcome were: degree of disability (all models), ≥2 previous spine surgeries, psychosocial complaints, age (onset <20 or >50), and patient expectations of treatment outcomes. The explained variances were low for the models predicting response and non-response to pain management program (R2 respectively 23% and 26%) and modest for surgery (R2 30% and 39%). The overall performance was acceptable (c-index; 0.72–0.83), the model predicting non-response to surgery performed best (R2 = 39%; c-index = 0.83). Conclusion: This study was the first to identify different patient-reported profiles that predict response to different treatments for CLBP. The model predicting ‘non-response’ to elective lumbar spine surgery performed remarkably well, suggesting that referrals of these patients to a spine surgeon could be avoided. After external validation, the patient-reported profiles could potentially enhance timely patient triage to the right secondary care specialist and improve decision-making between clinican and patient. This could lead to improved treatment outcomes, which results in a more efficient use of healthcare resources. [ABSTRACT FROM AUTHOR]

Background: There is limited evidence on the cost effectiveness of Internet-based treatments for depression. The aim was to evaluate the cost effectiveness of guided Internet-based interventions for depression compared to controls.Methods: Individual-participant data from five randomized controlled trials (RCT), including 1,426 participants, were combined. Cost-effectiveness analyses were conducted at 8 weeks, 6 months, and 12 months follow-up.Results: The guided Internet-based interventions were more costly than the controls, but not statistically significant (12 months mean difference = €406, 95% CI: - 611 to 1,444). The mean differences in clinical effects were not statistically significant (12 months mean difference = 1.75, 95% CI: - .09 to 3.60 in Center for Epidemiologic Studies Depression Scale [CES-D] score, .06, 95% CI: - .02 to .13 in response rate, and .00, 95% CI: - .03 to .03 in quality-adjusted life-years [QALYs]). Cost-effectiveness acceptability curves indicated that high investments are needed to reach an acceptable probability that the intervention is cost effective compared to control for CES-D and response to treatment (e.g., at 12-month follow-up the probability of being cost effective was .95 at a ceiling ratio of 2,000 €/point of improvement in CES-D score). For QALYs, the intervention's probability of being cost effective compared to control was low at the commonly accepted willingness-to-pay threshold (e.g., at 12-month follow-up the probability was .29 and. 31 at a ceiling ratio of 24,000 and 35,000 €/QALY, respectively).Conclusions: Based on the present findings, guided Internet-based interventions for depression are not considered cost effective compared to controls. However, only a minority of RCTs investigating the clinical effectiveness of guided Internet-based interventions also assessed cost effectiveness and were included in this individual-participant data meta-analysis. [ABSTRACT FROM AUTHOR]

Background: Mental disorders are associated with high costs for productivity loss, sickness absence and unemployment. A participatory supportive return to work (RTW) program was developed in order to improve RTW among workers without an employment contract, sick-listed due to a common mental disorder. The program contained a participatory approach, integrated care and direct placement in a competitive job. The aim of this study was to evaluate the cost-effectiveness and cost-utility of this new program, compared to usual care. In addition, its return on investment was evaluated.Methods: An economic evaluation was conducted alongside a 12-month randomized controlled trial. A total of 186 participants was randomly allocated to the new program (n = 94) or to usual care (n = 92). Effect measures were the duration until sustainable RTW in competitive employment and quality-adjusted life years (QALYs) gained. Costs included intervention costs, medical costs and absenteeism costs. Registered data of the Dutch Social Security Agency were used to assess the duration until sustainable RTW, intervention costs and absenteeism costs. QALYs and medical costs were assessed using three- or six-monthly questionnaires. Missing data were imputed using multiple imputations. Cost-effectiveness analysis and cost-utility analysis were conducted from the societal perspective. A return on investment analysis was conducted from the social insurer's perspective. Various sensitivity analyses were performed to assess the robustness of the results.Results: The new program had no significant effect on the duration until sustainable RTW and QALYs gained. Intervention costs and medical costs were significantly higher in the intervention group. From the societal perspective, the maximum probability of cost-effectiveness for duration until sustainable RTW was 0.64 at a willingness to pay of about €10 000/day, and 0.27 for QALYs gained, regardless of the willingness to pay. From the social insurer's perspective, the probability of financial return was 0.18.Conclusions: From the societal perspective, the new program was neither cost-effective in improving sustainable RTW nor in gaining QALYs. From the social insurer's perspective, the program did not result in a positive financial return. Therefore, the present study provided no evidence to support its implementation.Trial Registration: The trial was listed at the Dutch Trial Register (NTR) under NTR3563 on August 7, 2012. [ABSTRACT FROM AUTHOR]

Background: Improved organization of trauma care in the acute phase has reduced mortality of trauma patients. However, there has been limited attention for the optimal organization of post-clinical rehabilitation of trauma patients. Therefore we developed a Transmural Trauma Care Model (TTCM). This TTCM consists of four equally important components: 1) intake and follow up consultations by a multidisciplinary team consisting of trauma surgeon and hospital based trauma physical therapist, 2) coordination and individual goal setting for each patient by this team, 3) primary care physical therapy by specialized physical therapists organized in a network and 4) E-health support for transmural communication and treatment according to protocols. The aim of the current study is to assess the cost-effectiveness of the TTCM.Methods: Patients will be recruited from the outpatient clinic for trauma patients of the VU University Medical Center (VUmc) if they have at least one fracture and were discharged home. A controlled-before-and-after study design will be used to compare the TTCM with regular care. Measurements will take place after the first outpatient clinical visit and after 3, 6 and 9 months. Prior to the implementation of the TTCM, 200 patients (50 patients per time point) will be included in the control group. After implementation 100 patients will be included in the intervention group and prospectively followed. Between-group comparisons will be made separately for each time point. In addition, the recovery pattern of patients in the intervention group will be studied using longitudinal data analysis methods. Effectiveness will be evaluated in terms of health-related quality of life (HR-QOL), pain, functional status, patient satisfaction, and perceived recovery. Cost-effectiveness will be assessed from a societal perspective, meaning that all costs related to the TTCM will be taken into account including intervention, health care, absenteeism, presenteeism and unpaid productivity. Additionally, a process evaluation will be performed to explore the extent to which the TTCM was implemented as intended, and to identify possible facilitators and barriers associated with its implementation.Discussion: This planned research will give insight into the feasibility of the TTCM model in clinical practice and will give a first indication of the cost-effectiveness of the TTCM and help us to further develop post-clinical trauma care.Trial Registration: Trial registration number: NTR5474 . The Netherlands National Trial Register (NTR). Registered 12 October 2015. [ABSTRACT FROM AUTHOR]

Background: The use of economic evaluations in healthcare decision-making can potentially help decision-makers in allocating scarce resources as efficiently as possible. Over a decade ago, the use of such studies was found to be limited in Dutch healthcare decision-making, but their current use is unknown. Therefore, this study aimed to provide insight into the current and potential use of economic evaluations in Dutch healthcare decision-making and to identify barriers and facilitators to the use of such studies.Methods: Interviews containing semi-structured and structured questions were conducted among Dutch healthcare decision-makers. Participants were purposefully selected and special efforts were made to include decision-makers working at the macro- (national), meso- (local/regional), and micro-level (patient setting). During the interviews, a topic list was used that was based on the research questions and a literature search, and was developed in consultation with the Dutch National Healthcare Institute. Responses to the semi-structured questions were analyzed using a constant comparative approach. As for the structured questions, participants' definitions of various economic evaluation concepts were scored as either being "correct" or "incorrect" by two researchers, and summary statistics were prepared.Results: Sixteen healthcare decision-makers were interviewed and two health economists. Decision-makers' knowledge of economic evaluations was only modest, and their current use appeared to be limited. Nonetheless, decision-makers recognized the importance of economic evaluations and saw several opportunities for extending their use at the macro- and meso-level, but not at the micro-level. The disparity between the limited use and recognition of the importance of economic evaluations is likely due to the many barriers decision-makers experience preventing their use (e.g. lack of resources, lack of formal willingness-to-pay threshold). Possible facilitators for extending the use of economic evaluations include, amongst others, educating decision-makers and the general population about economic evaluations and presenting economic evaluation results in a clearer and more understandable way.Conclusions: This study demonstrated that the current use and impact of economic evaluations in Dutch healthcare decision-making is limited at best. Therefore, strategies are needed to overcome the barriers that currently prevent economic evaluations from being used extensively. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to conduct a cost-effectiveness and return-on-investment analysis comparing a mindfulness-based worksite intervention to usual practice. Methods: Two hundred fifty-seven governmental research institute employees were randomized to the intervention or control group. Intervention group participants received an eight-week mind-fulness training, e-coaching, and supporting elements. Outcomes included work engagement, general vitality, job satisfaction, work ability, and costs. Cost-effectiveness analyses were conducted from the societal and employer's perspective, and a return-on-investment analysis from the employer's perspective. Results: After 12 months, a significant but not clinically relevant adverse effect on work engagement was found (-0.19; 95% confidence interval: -0.38 to -0.01). There were no significant differences in job satisfaction, general vitality, work ability, and total costs. Probabilities of cost-effectiveness were low (≤0.25) and the intervention did not have a positive financial return to the employer. Conclusion: The intervention was neither cost-saving nor cost-effective. Poor e-coaching compliance might partly explain this result. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the cost-effectiveness of a multifaceted implementation strategy for the prevention of hand eczema in comparison with a control group among healthcare workers. A total of 48 departments (n = 1,649) were randomly allocated to the implementation strategy or the control group. Data on hand eczema and costs were collected at baseline and every 3 months. Cost-effectiveness analyses were performed using linear multilevel analyses. The probability of the implementation strategy being cost-effective gradually increased with an increasing willingness-to-pay, to 0.84 at a ceiling ratio of €590,000 per person with hand eczema prevented (societal perspective). The implementation strategy appeared to be not cost-effective in comparison with the control group (societal perspective), nor was it cost-beneficial to the employer. However, this study had some methodological problems which should be taken into account when interpreting the results. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the cost-effectiveness of a Web-based guided intervention compared with care as usual for employees with depressive symptoms. Methods: A total of 231 employees with depressive symptoms were randomized. Data were collected at baseline, 8 weeks, 6 months, and 12 months. Analyses were conducted from the societal and employer's perspective. Results: At 12 months, a significant intervention effect on depressive symptoms was found. At a willingness to pay of 0 (€/unit of effect), the intervention's probabilities of cost-effectiveness were 0.62 (societal perspective) and 0.55 (employer's perspective). There was a 0.63 probability that the intervention resulted in a positive financial return for the employer. Conclusions: The intervention's cost-effectiveness with regard to depressive symptoms depends on the willingness to pay of societal and company decision makers as well as the probability of cost-effectiveness that they consider acceptable. The intervention is not cost-saving to the employer. [ABSTRACT FROM AUTHOR]

To allocate available resources as efficiently as possible, decision makers need information on the relative economic merits of occupational health and safety (OHS) interventions. Economic evaluations can provide this information by comparing the costs and consequences of alternatives. Nevertheless, only a few of the studies that consider the effectiveness of OHS interventions take the extra step of considering their resource implications. Moreover, the methodological quality of those that do is generally poor. Therefore, this study aims to help occupational health researchers conduct high-quality trial-based economic evaluations by discussing the theory and methodology that underlie them, and by providing recommendations for good practice regarding their design, analysis, and reporting. This study also helps consumers of this literature with understanding and critically appraising trial-based economic evaluations of OHS interventions. [ABSTRACT FROM AUTHOR]

Background: Continued improvements in occupational health can only be ensured if decisions regarding the implementation and continuation of occupational health and safety interventions (OHS interventions) are based on the best available evidence. To ensure that this is the case, scientific evidence should meet the needs of decisionmakers. As a first step in bridging the gap between the economic evaluation literature and daily practice in occupational health, this study aimed to provide insight into the occupational health decision-making process and information needs of decision-makers. Methods: An exploratory qualitative study was conducted with a purposeful sample of occupational health decision-makers in the Ontario healthcare sector. Eighteen in-depth interviews were conducted to explore the process by which occupational health decisions are made and the importance given to the financial implications of OHS interventions. Twenty-five structured telephone interviews were conducted to explore the sources of information used during the decision-making process, and decision-makers' knowledge on economic evaluation methods. In-depth interview data were analyzed according to the constant comparative method. For the structured telephone interviews, summary statistics were prepared. Results: The occupational health decision-making process generally consists of three stages: initiation stage, establishing the need for an intervention; pre-implementation stage, developing an intervention and its business case in order to receive senior management approval; and implementation and evaluation stage, implementing and evaluating an intervention. During this process, information on the financial implications of OHS interventions was found to be of great importance, especially the employer's costs and benefits. However, scientific evidence was rarely consulted, sound ex-post program evaluations were hardly ever performed, and there seemed to be a need to advance the economic evaluation skill set of decision-makers Conclusions: Financial information is particularly important at the front end of implementation decisions, and can be a key deciding factor of whether to go forward with a new OHS intervention. In addition, it appears that current practice in occupational health in the healthcare sector is not solidly grounded in evidence-based decision-making and strategies should be developed to improve this. [ABSTRACT FROM AUTHOR]

The article discusses a randomized controlled trial conducted on cost-effectiveness and return-on-investment analysis of a worksite vitality intervention among older hospital workers. The intervention was for six months and consisted of yoga and aerobic exercises. Result was neither cost-effective nor cost-saving.

Background: In 2006, the Dutch government initiated Hello World, an email-based program promoting healthy lifestyles among pregnant women through quizzes with pregnancy-related questions. In 2008, an updated version was released. The present study aimed to (1) examine the reach of Hello World and the representativeness of its users for all pregnant women in the Netherlands, (2) explore the relationship between program engagement and lifestyle characteristics, and (3) explore the relationship between the program content participants accessed (content on smoking, physical activity, and nutrition) and their lifestyle characteristics. Methods: Data from 4,363 pregnant women were included. After registration, women received an online questionnaire with demographic and lifestyle questions. To evaluate their representativeness, their demographic characteristics were compared with existing data for Dutch (pregnant) women. Women were classified on the following lifestyle characteristics: smoking, nutrition, physical activity, and pre-pregnancy weight status. Program use was tracked and the relationships between lifestyle characteristics, program engagement, and the percentage of smoking, physical activity, and nutrition questions accessed after opening a quiz were explored using Mann--Whitney U tests and Kruskal-Wallis tests. Results: Hello World reached ±4% of its target population. Ten percent of participants were low educated and 22% immigrants. On average, women received 6.1 (SD:2.8) quiz emails and opened 32% of the associated quizzes (2.0, SD:2.1). A significant positive association was found between the number of quizzes opened and the number of healthy lifestyle characteristics. After opening a quiz, women accessed most smoking, nutrition, and physical activity questions. Significant relationships were found between several lifestyle characteristics and the percentage of smoking, physical activity, and nutrition questions accessed. However, between-group differences were small, quiz topics were largely unrelated to their lifestyle characteristics, and inconsistencies were found regarding the directions of these associations. Conclusions: Hello World reached ±4% of its target population, which is lower than the reach of its previous version (±8%). Relatively few low educated and immigrant women registered for the program. Active participation in the program was positively associated with the number of healthy behaviours participants engaged in. The program content participants chose to access was largely unrelated to their lifestyle characteristics. [ABSTRACT FROM AUTHOR]

Background: Pressure ulcers (PUs) on the buttocks are among the most common secondary complications in individuals with chronic spinal cord injury (SCI). PUs can result from sitting for extended periods, disuse atrophy, increased sitting pressure and reduced circulation. Compared with usual care, activation of paralysed muscles using electrical stimulation (ES) has been shown to markedly increase paralysed muscle mass, improve circulation of skin and muscle and improve sitting pressure distribution. ES might therefore be a useful method to reduce PU incidence.Methods: A multicentre randomized controlled trial (SCI PREVOLT) will be conducted with an economic and process evaluation alongside. One hundred participants with a SCI in the chronic phase and a minimal incidence of 1 PU in the last 5 years will be recruited from rehabilitation centres across the Netherlands. Participants will be stratified by centre and age and randomized to the intervention or control group. The intervention group will use ES at least 1 h/day during at least 4 times a week for 1 year next to usual care. The control group will only receive usual care. The primary outcome is the incidence of PUs, measured by a blinded person assessing the presence or absence of a PU on the buttocks on a photo made by the participant or his/her caregiver. The incidence of a PU will be evaluated every 2 weeks. Secondary outcomes include interface pressure distribution, blood flow in the profunda femoris artery, muscle thickness of the hamstrings and gluteal muscles and questionnaires about different dimensions of life, e.g. participation and quality of life. Secondary outcomes will be measured at baseline and 3, 6, 9 and 12 months after randomization.Discussion: This study will assess if electrical stimulation is a (cost-)effective method to prevent PUs and reduce the risk factors of getting PUs. If ES is effective and cost-effective compared with usual care, ES could be implemented in daily treatment of individuals with a SCI.Trial Registration: Netherlands Trials Register NTR NL9469 . Registered on 26 May 2021. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

Background: To assess the barriers and facilitators associated with upscaling the Transmural Trauma Care Model (TTCM), a multidisciplinary and patient‐centred transmural rehabilitation care model. Methods: Semi-structured interviews were conducted with eight trauma surgeons, eight hospital-based physiotherapists, eight trauma patients, and eight primary care physiotherapists who were part of a trauma rehabilitation network. Audio recordings of the interviews were made and transcribed verbatim. Data were analysed using a framework method based on the "constellation approach". Identified barriers and facilitators were grouped into categories related to structure, culture, and practice. Results: Various barriers and facilitators to upscaling were identified. Under structure, barriers and facilitators belonged to one of five themes: "financial structure", "communication structure", "physical structures and resources", "rules and regulations", and "organisation of the network". Under culture, the five themes were "commitment", "job satisfaction", "acting as a team", "quality and efficiency of care", and "patients' experience". Under practice, the two themes were "practical issues at the outpatient clinic" and "knowledge gained". Conclusion: The success of upscaling the TTCM differed across hospitals and settings. The most important prerequisites for successfully upscaling the TTCM were adequate financial support and presence of "key actors" within an organisation who felt a sense of urgency for change and/or expected the intervention to increase their job satisfaction. Trial registration: NL8163 The Netherlands National Trial Register, date of registration 16-11-2019. [ABSTRACT FROM AUTHOR]

Background: The prevalence of knee osteoarthritis is increasing worldwide. Obesity is an important modifiable risk factor for both the incidence and progression of knee osteoarthritis. Consequently, international guidelines recommend all patients with knee osteoarthritis who are overweight receive support to lose weight. However, few overweight patients with this condition receive care to support weight loss. Telephone-based interventions are one potential solution to provide scalable care to the many patients with knee osteoarthritis. The objective of this study is to evaluate, from a societal perspective, the cost-utility and cost-effectiveness of a telephone-based weight management and healthy lifestyle service for patients with knee osteoarthritis, who are overweight or obese.Methods: An economic evaluation was undertaken alongside a pragmatic randomised controlled trial. Between May 19 and June 30, 2015, 120 patients with knee osteoarthritis were randomly assigned to an intervention or usual care control group in a 1:1 ratio. Participants in the intervention group received a referral to an existing non-disease specific 6-month telephone-based weight management and healthy lifestyle service. Quality-adjusted life years (QALYs) was the utility measure and knee pain intensity, disability, weight, and body mass index (BMI) were the clinical measures of effect. Costs included intervention costs, healthcare utilisation costs (healthcare services and medication use) and absenteeism costs due to knee pain. Data was collected at baseline, 6 weeks and 26 weeks. The primary cost-effectiveness analysis was performed from the societal perspective.Results: Mean cost differences between groups (intervention minus control) were $493 (95%CI: -3513 to 5363) for healthcare costs, $-32 (95%CI: -73 to 13) for medication costs, and $125 (95%CI: -151 to 486) for absenteeism costs. The total mean difference in societal costs was $1197 (95%CI: -2887 to 6106). For QALYs and all clinical measures of effect, the probability of the intervention being cost-effective compared with usual care was less than 0.36 at all willingness-to-pay values.Conclusions: From a societal perspective, telephone-based weight loss support, provided using an existing non-disease specific 6-month weight management and healthy lifestyle service was not cost-effective in comparison with usual care for overweight and obese patients with knee osteoarthritis.Trial Registration Number: ACTRN12615000490572 , registered 18th May 2015. [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

Objective: The rehabilitation of trauma patients in primary care is challenging, and there are no guidelines for optimal treatment. Also, the organization of care is not well‐structured. The Transmural Trauma Care Model (TTCM) has been developed in the Netherlands, aiming to improve patient outcomes by optimizing the organization and the quality of the rehabilitation process in primary care. A recent feasibility study showed that implementation of the TTCM at a Dutch Level 1 trauma center was feasible, patient outcomes were improved, and costs were reduced. This study aims to assess the effectiveness and cost‐effectiveness of the TTCM compared to the usual care in a multicenter trial. Methods: A multicenter trial with a controlled before‐and‐after design will be performed at 10 hospitals in the Netherlands. First, participating hospitals will include 322 patients in the control group, receiving usual care as provided in these specific hospitals. Subsequently, the TTCM will be implemented in all participating hospitals, and hospitals will include an additional 322 patients in the intervention group. The TTCM consists of a multidisciplinary team at the outpatient clinic (trauma surgeon and hospital‐based physical therapist), an educated and trained network of primary care trauma physical therapists, and structural communication between them. Co‐primary outcomes will investigate generic and disease‐specific, health‐related quality of life. Secondary outcomes will include pain, patient satisfaction, perceived recovery, and patient‐reported physical functioning. For the economic evaluation, societal and healthcare costs will be measured. Measurements will take place at baseline and after 6 weeks, 3, 6, and 9 months. Analyses will be based on the intention‐to‐treat principle. Missing data will be handled using longitudinal data analyses in the effect analyses and by multivariate imputation in the economic evaluation. Conclusion: This trial with a controlled before‐and‐after design will give insight into the effectiveness and cost‐effectiveness of the TTCM in a multicenter trial. [ABSTRACT FROM AUTHOR]

Background: Patient education, advice on returning to normal activities and (home-based) exercise therapy are established treatment options for patients with non-specific low back pain (LBP). However, the effectiveness of physiotherapy interventions on physical functioning and prevention of recurrent events largely depends on patient self-management, adherence to prescribed (home-based) exercises and recommended physical activity behaviour. Therefore we have developed e-Exercise LBP, a blended intervention in which a smartphone application is integrated within face-to-face care. E-Exercise LBP aims to improve patient self-management skills and adherence to exercise and physical activity recommendations and consequently improve the effectiveness of physiotherapy on patients' physical functioning. The aim of this study is to investigate the short- (3 months) and long-term (12 and 24 months) effectiveness on physical functioning and cost-effectiveness of e-Exercise LBP in comparison to usual primary care physiotherapy in patients with LBP.Methods: This paper presents the protocol of a prospective, multicentre cluster randomized controlled trial. In total 208 patients with LBP pain were treated with either e-Exercise LBP or usual care physiotherapy. E-Exercise LBP is stratified based on the risk for developing persistent LBP. Physiotherapists are able to monitor and evaluate treatment progress between face-to-face sessions using patient input from the smartphone application in order to optimize physiotherapy care. The smartphone application contains video-supported self-management information, video-supported exercises and a goal-oriented physical activity module. The primary outcome is physical functioning at 12-months follow-up. Secondary outcomes include pain intensity, physical activity, adherence to prescribed (home-based) exercises and recommended physical activity behaviour, self-efficacy, patient activation and health-related quality of life. All measurements will be performed at baseline, 3, 12 and 24 months after inclusion. An economic evaluation will be performed from the societal and the healthcare perspective and will assess cost-effectiveness of e-Exercise LBP compared to usual physiotherapy at 12 and 24 months.Discussion: A multi-phase development and implementation process using the Center for eHealth Research Roadmap for the participatory development of eHealth was used for development and evaluation. The findings will provide evidence on the effectiveness of blended care for patients with LBP and help to enhance future implementation of blended physiotherapy.Trial Registration: ISRCTN, ISRCTN94074203. Registered 20 July 2018 - Retrospectively registered. [ABSTRACT FROM AUTHOR]

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. 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 (R 2 ), 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. The Non-p performed the best (R 2 = 0.43; RMSE = 0.22; MAE = 0.03; 95% LA = −0.40 to 0.47) compared with the Non-peLI (R 2 = 0.07; RMSE = 0.29; MAE = −0.15; 95% LA = −0.63 to 0.34) and OLR (R 2 = 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). 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. • Regression models can be validly used to predict EQ-5D-3L utility values from the Oswestry Disability Index (ODI) in cost-utility analyses. • This study developed and assessed the validity of response mapping approaches for mapping ODI responses to EQ-5D-3L utility values and the impact of using mapped utility values on cost-utility results compared with published regression models. • Results suggest that response mapping approaches are not valid for estimating EQ-5D-3L utility values for individual patients based on ODI responses. Furthermore, response mapping approaches may not have added value compared with published regression models for use in economic evaluations when EQ-5D-3L data were not collected. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: A healthy lifestyle is indispensable for the prevention of noncommunicable diseases. However, lifestyle medicine is hampered by time constraints and competing priorities of treating physicians. A dedicated lifestyle front office (LFO) in secondary/tertiary care may provide an important contribution to optimize patient-centred lifestyle care and connect to lifestyle initiatives from the community. The LOFIT study aims to gain insight into the (cost-)effectiveness of the LFO. Methods: Two parallel pragmatic randomized controlled trials will be conducted for (cardio)vascular disorders (i.e. (at risk of) (cardio)vascular disease, diabetes) and musculoskeletal disorders (i.e. osteoarthritis, hip or knee prosthesis). Patients from three outpatient clinics in the Netherlands will be invited to participate in the study. Inclusion criteria are body mass index (BMI) ≥25 (kg/m2) and/or smoking. Participants will be randomly allocated to either the intervention group or a usual care control group. In total, we aim to include 552 patients, 276 in each trial divided over both treatment arms. Patients allocated to the intervention group will participate in a face-to-face motivational interviewing (MI) coaching session with a so-called lifestyle broker. The patient will be supported and guided towards suitable community-based lifestyle initiatives. A network communication platform will be used to communicate between the lifestyle broker, patient, referred community-based lifestyle initiative and/or other relevant stakeholders (e.g. general practitioner). The primary outcome measure is the adapted Fuster-BEWAT, a composite health risk and lifestyle score consisting of resting systolic and diastolic blood pressure, objectively measured physical activity and sitting time, BMI, fruit and vegetable consumption and smoking behaviour. Secondary outcomes include cardiometabolic markers, anthropometrics, health behaviours, psychological factors, patient-reported outcome measures (PROMs), cost-effectiveness measures and a mixed-method process evaluation. Data collection will be conducted at baseline, 3, 6, 9 and 12 months follow-up. Discussion: This study will gain insight into the (cost-)effectiveness of a novel care model in which patients under treatment in secondary or tertiary care are referred to community-based lifestyle initiatives to change their lifestyle. Trial registration: ISRCTN ISRCTN13046877. Registered 21 April 2022. [ABSTRACT FROM AUTHOR]

Background: Continued improvements in occupational health can only be ensured if decisions regarding the implementation and continuation of occupational health and safety interventions (OHS interventions) are based on the best available evidence. To ensure that this is the case, scientific evidence should meet the needs of decision-makers. As a first step in bridging the gap between the economic evaluation literature and daily practice in occupational health, this study aimed to provide insight into the occupational health decision-making process and information needs of decision-makers.Methods: An exploratory qualitative study was conducted with a purposeful sample of occupational health decision-makers in the Ontario healthcare sector. Eighteen in-depth interviews were conducted to explore the process by which occupational health decisions are made and the importance given to the financial implications of OHS interventions. Twenty-five structured telephone interviews were conducted to explore the sources of information used during the decision-making process, and decision-makers' knowledge on economic evaluation methods. In-depth interview data were analyzed according to the constant comparative method. For the structured telephone interviews, summary statistics were prepared.Results: The occupational health decision-making process generally consists of three stages: initiation stage, establishing the need for an intervention; pre-implementation stage, developing an intervention and its business case in order to receive senior management approval; and implementation and evaluation stage, implementing and evaluating an intervention. During this process, information on the financial implications of OHS interventions was found to be of great importance, especially the employer's costs and benefits. However, scientific evidence was rarely consulted, sound ex-post program evaluations were hardly ever performed, and there seemed to be a need to advance the economic evaluation skill set of decision-makers.Conclusions: Financial information is particularly important at the front end of implementation decisions, and can be a key deciding factor of whether to go forward with a new OHS intervention. In addition, it appears that current practice in occupational health in the healthcare sector is not solidly grounded in evidence-based decision-making and strategies should be developed to improve this. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Neck and shoulder complaints are common in primary care physiotherapy. These patients experience pain and disability, resulting in high societal costs due to, for example, healthcare use and work absence. Content and intensity of physiotherapy care can be matched to a patient's risk of persistent disabling pain. Mode of care delivery can be matched to the patient's suitability for blended care (integrating eHealth with physiotherapy sessions). It is hypothesized that combining these two approaches to stratified care (referred to from this point as Stratified Blended Approach) will improve the effectiveness and cost-effectiveness of physiotherapy for patients with neck and/or shoulder complaints compared to usual physiotherapy.Methods: This paper presents the protocol of a multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial. A total of 92 physiotherapists will be recruited from Dutch primary care physiotherapy practices. Physiotherapy practices will be randomized to the Stratified Blended Approach arm or usual physiotherapy arm by a computer-generated random sequence table using SPSS (1:1 allocation). Number of physiotherapists (1 or > 1) will be used as a stratification variable. A total of 238 adults consulting with neck and/or shoulder complaints will be recruited to the trial by the physiotherapy practices. In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient's risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient's suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual. Neither physiotherapists nor patients in the control arm will be informed about the Stratified Blended Approach arm. The primary outcome is region-specific pain and disability (combined score of Shoulder Pain and Disability Index & Neck Pain and Disability Scale) over 9 months. Effectiveness will be compared using linear mixed models. An economic evaluation will be performed from the societal and healthcare perspective.Discussion: The trial will be the first to provide evidence on the effectiveness and cost-effectiveness of the Stratified Blended Approach compared with usual physiotherapy in patients with neck and/or shoulder complaints.Trial Registration: Netherlands Trial Register: NL8249 . Officially registered since 27 December 2019. Date of first enrollment: 30 September 2020. Study status: ongoing, data collection. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Instructing and guiding patients after surgery is essential for successful recovery. However, the time that health-care professionals can spend with their patients postoperatively has been reduced because of efficiency-driven, shortened hospital stays. We evaluated the effect of a personalised e-health-care programme on return to normal activities after surgery.Methods: A multicentre, single-blind, randomised controlled trial was done at seven teaching hospitals in the Netherlands. Patients aged 18-75 years who were scheduled for laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication were recruited. An independent researcher randomly allocated participants to either the intervention or control group using computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised, e-health-care programme, which managed recovery expectations and provided postoperative guidance tailored to the patient. The control group received usual care and access to a placebo website containing standard general recovery advice. Participants were unaware of the study hypothesis and were asked to complete questionnaires at five timepoints during the 6-month period after surgery. The primary outcome was time between surgery and return to normal activities, measured using personalised patient-reported outcome measures. Intention-to-treat and per-protocol analyses were done. This trial is registered in the Netherlands National Trial Register, number NTR4699.Findings: Between Aug 24, 2015, and Aug 12, 2016, 344 participants were enrolled and randomly allocated to either the intervention (n=173) or control (n=171) group. 14 participants (4%) were lost to follow-up, with 330 participants included in the primary outcome analysis. Median time until return to normal activities was 21 days (95% CI 17-25) in the intervention group and 26 days (20-32) in the control group (hazard ratio 1·38, 95% CI 1·09-1·73; p=0·007). Complications did not differ between groups.Interpretation: A personalised e-health intervention after abdominal surgery speeds up the return to normal activities compared with usual care. Implementation of this e-health programme is recommended in patients undergoing intermediate-grade abdominal, gynaecological, or general surgical procedures.Funding: ZonMw. [ABSTRACT FROM AUTHOR]

Purpose: It is unknown which chronic low back pain (CLBP) patients are typically referred to spinal surgery. The present study, therefore, aimed to explore which patient-reported factors are predictive of spinal surgery referral among CLBP patients.Methods: CLBP patients were consecutively recruited from a Dutch orthopedic hospital specialized in spine care (n = 4987). The outcome of this study was referral to spinal surgery (yes/no), and was assessed using hospital records. Possible predictive factors were assessed using a screening questionnaire. A prediction model was constructed using logistic regression, with backwards selection and p < 0.10 for keeping variables in the model. The model was internally validated and evaluated using discrimination and calibration measures.Results: Female gender, previous back surgery, high intensity leg pain, somatization, and positive treatment expectations increased the odds of being referred to spinal surgery, while being obese, having comorbidities, pain in the thoracic spine, increased walking distance, and consultation location decreased the odds. The model's fit was good (X 2 = 10.5; p = 0.23), its discriminative ability was poor (AUC = 0.671), and its explained variance was low (5.5%). A post hoc analysis indicated that consultation location was significantly associated with spinal surgery referral, even after correcting for case-mix variables.Conclusion: Some patient-reported factors could be identified that are predictive of spinal surgery referral. Although the identified factors are known as common predictive factors of surgery outcome, they could only partly predict spinal surgery referral. [ABSTRACT FROM AUTHOR]

Background and Objectives: The aim was to systematically review whether the reporting and analysis of trial-based cost-effectiveness evaluations in the field of obstetrics and gynaecology comply with guidelines and recommendations, and whether this has improved over time.Data Sources and Selection Criteria: A literature search was performed in MEDLINE, the NHS Economic Evaluation Database (NHS EED) and the Health Technology Assessment (HTA) database to identify trial-based cost-effectiveness evaluations in obstetrics and gynaecology published between January 1, 2000 and May 16, 2017. Studies performed in middle- and low-income countries and studies related to prevention, midwifery, and reproduction were excluded.Data Collection and Analysis: Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standard (CHEERS) statement (a modified version with 21 items, as we focused on trial-based cost-effectiveness evaluations) and the statistical quality was assessed using a literature-based list of criteria (8 items). Exploratory regression analyses were performed to assess the association between reporting and statistical quality scores and publication year.Results: The electronic search resulted in 5482 potentially eligible studies. Forty-five studies fulfilled the inclusion criteria, 22 in obstetrics and 23 in gynaecology. Twenty-seven (60%) studies did not adhere to 50% (n = 10) or more of the reporting quality items and 32 studies (71%) did not meet 50% (n = 4) or more of the statistical quality items. As for the statistical quality, no study used the appropriate method to assess cost differences, no advanced methods were used to deal with missing data, and clustering of data was ignored in all studies. No significant improvements over time were found in reporting or statistical quality in gynaecology, whereas in obstetrics a significant improvement in reporting and statistical quality was found over time.Limitations: The focus of this review was on trial-based cost-effectiveness evaluations in obstetrics and gynaecology, so further research is needed to explore whether results from this review are generalizable to other medical disciplines.Conclusions and Implications Of Key Findings: The reporting and analysis of trial-based cost-effectiveness evaluations in gynaecology and obstetrics is generally poor. Since this can result in biased results, incorrect conclusions, and inappropriate healthcare decisions, there is an urgent need for improvement in the methods of cost-effectiveness evaluations in this field. [ABSTRACT FROM AUTHOR]

Importance: Radiofrequency denervation is a commonly used treatment for chronic low back pain, but high-quality evidence for its effectiveness is lacking.Objective: To evaluate the effectiveness of radiofrequency denervation added to a standardized exercise program for patients with chronic low back pain.Design, Setting, and Participants: Three pragmatic multicenter, nonblinded randomized clinical trials on the effectiveness of minimal interventional treatments for participants with chronic low back pain (Mint study) were conducted in 16 multidisciplinary pain clinics in the Netherlands. 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 (facet joint trial, 251 participants), sacroiliac joints (sacroiliac joint trial, 228 participants), or a combination of facet joints, sacroiliac joints, or intervertebral disks (combination trial, 202 participants) and were unresponsive to conservative care.Interventions: All participants received a 3-month standardized exercise program and psychological support if needed. Participants in the intervention group received radiofrequency denervation as well. This is usually a 1-time procedure, but the maximum number of treatments in the trial was 3.Main Outcomes and Measures: The primary outcome was pain intensity (numeric rating scale, 0-10; whereby 0 indicated no pain and 10 indicated worst pain imaginable) measured 3 months after the intervention. The prespecified minimal clinically important difference was defined as 2 points or more. Final follow-up was at 12 months, ending October 2015.Results: Among 681 participants who were randomized (mean age, 52.2 years; 421 women [61.8%], mean baseline pain intensity, 7.1), 599 (88%) completed the 3-month follow-up, and 521 (77%) completed the 12-month follow-up. The mean difference in pain intensity between the radiofrequency denervation and control groups at 3 months was -0.18 (95% CI, -0.76 to 0.40) in the facet joint trial; -0.71 (95% CI, -1.35 to -0.06) in the sacroiliac joint trial; and -0.99 (95% CI, -1.73 to -0.25) in the combination trial.Conclusions and Relevance: In 3 randomized clinical trials of participants with chronic low back pain originating in the facet joints, sacroiliac joints, or a combination of facet joints, sacroiliac joints, or intervertebral disks, radiofrequency denervation combined with a standardized exercise program resulted in either no improvement or no clinically important improvement in chronic low back pain compared with a standardized exercise program alone. The findings do not support the use of radiofrequency denervation to treat chronic low back pain from these sources.Trial Registration: trialregister.nl Identifier: NTR3531. [ABSTRACT FROM AUTHOR]

Objectives: Depression is associated with considerable impairments in health-related quality-of-life. However, the relationship between different health states related to depression severity and utility scores is unclear. The aim of this study was to evaluate whether utility scores are different for various health states related to depression severity.Methods: We gathered individual participant data from ten randomized controlled trials evaluating depression treatments. The UK EQ-5D and SF-6D tariffs were used to generate utility scores. We defined five health states that were proposed from American Psychiatric Association and National Institute for Clinical Excellence guidelines: remission, minor depression, mild depression, moderate depression, and severe depression. We performed multilevel linear regression analysis.Results: We included 1629 participants in the analyses. The average EQ-5D utility scores for the five health states were 0.70 (95% CI 0.67-0.73) for remission, 0.62 (95% CI 0.58-0.65) for minor depression, 0.57 (95% CI 0.54-0.61) for mild depression, 0.52 (95%CI 0.49-0.56) for moderate depression, and 0.39 (95% CI 0.35-0.43) for severe depression. In comparison with the EQ-5D, the utility scores based on the SF-6D were similar for remission (EQ-5D = 0.70 vs. SF-6D = 0.69), but higher for severe depression (EQ-5D = 0.39 vs. SF-6D = 0.55).Conclusions: We observed statistically significant differences in utility scores between depression health states. Individuals with less severe depressive symptoms had on average statistically significant higher utility scores than individuals suffering from more severe depressive symptomatology. In the present study, EQ-5D had a larger range of values as compared to SF-6D. [ABSTRACT FROM AUTHOR]

• Current evidence showed that exercise therapy is a cost-effective treatment in knee OA. • Our stratified approach of exercise therapy did not appear to be cost-effective compared to usual exercise therapy. • Policy-makers should decide whether stratified exercise therapy can be implemented. A stratified approach to exercise therapy may yield superior clinical and economic outcomes, given the large heterogeneity of individuals with knee osteoarthritis (OA). To evaluate the cost-effectiveness during a 12-month follow-up of a model of stratified exercise therapy compared to usual exercise therapy in patients with knee OA, from a societal and healthcare perspective. An economic evaluation was conducted alongside a cluster-randomized controlled trial in patients with knee OA (n = 335), comparing subgroup-specific exercise therapy for a 'high muscle strength subgroup', 'low muscle strength subgroup', and 'obesity subgroup' supplemented by a dietary intervention for the 'obesity subgroup' (experimental group), with usual ('non-stratified') exercise therapy (control group). Clinical outcomes included quality-adjusted life years – QALYs (EuroQol-5D-5 L), knee pain (Numerical Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score in daily living). Costs were measured by self-reported questionnaires at 3, 6, 9 and 12-month follow-up. Missing data were imputed using multiple imputation. Data were analyzed through linear regression. Bootstrapping techniques were applied to estimate statistical uncertainty. During 12-month follow-up, there were no significant between-group differences in clinical outcomes. The total societal costs of the experimental group were on average lower compared to the control group (mean [95% confidence interval]: € 405 [-1728, 918]), albeit with a high level of uncertainty. We found a negligible difference in QALYs between groups (mean [95% confidence interval]: 0.006 [-0.011, 0.023]). The probability of stratified exercise therapy being cost-effective compared to usual exercise therapy from the societal perspective was around 73%, regardless of the willingness-to-pay threshold. However, this probability decreased substantially to 50% (willingness-to-pay threshold of €20.000/QALY) when using the healthcare perspective. Similar results were found for knee pain and physical functioning. We found no clear evidence that stratified exercise therapy is likely to be cost-effective compared to usual exercise therapy in patients with knee OA. However, results should be interpreted with caution as the study power was lower than intended, due to the Coronavirus disease (COVID-19) pandemic. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to examine the longitudinal relationship between job satisfaction and total productivity-related costs, and between job satisfaction and absenteeism and presenteeism costs separately. A secondary aim was to explore whether these relationships differed across job types. Methods: Linear generalized estimating equation analyses were used to explore the longitudinal relationships. To explore whether the relationships differed across job types, stratified analyses were performed. Results: A significant relationship was found between job satisfaction and total productivity-related costs [β = €-273; 95% confidence interval (95% CI): -407 to -200] and between job satisfaction and presenteeism costs (β = €-276; 95% CI: -367 to -235), but not between job satisfaction and absenteeism costs. These relationships differed across job types. Conclusions: Higher levels of job satisfaction were longitudinally related to lower total productivity-related costs and presenteeism costs, but not to lower absenteeism costs. These relationships seem to differ across job types. [ABSTRACT FROM AUTHOR]

Steeds meer bedrijven voelen zich geroepen bij te dragen aan de gezondheid van hun werknemers. Leefstijlprogramma´s voor werknemers schieten als paddenstoelen uit de grond. Maar zijn deze wel zo nuttig als we denken? Dit artikel beschrijft de effectiviteit van drie unieke Vitaal in Praktijk-leefstijlprogramma´s bij werknemers in de bouw, in het verzekeringswezen en in het onderzoek. De onderzoeken tonen aan dat de op maat gemaakte leefstijlprogramma´s weinig of geen impact hadden op het verbeteren van werkuitkomsten, zoals verzuim. Wel blijkt dat een hogere werktevredenheid samenhangt met lagere kosten voor verzuim en presenteïsme, wat interessante input is voor werkgevers en vervolgstudies. [ABSTRACT FROM AUTHOR]

Background: Exercise therapy in patients with hip and/or knee osteoarthritis is effective in reducing pain, increasing physical activity and physical functioning, but costly and a burden for the health care budget. A web-based intervention is cheap in comparison to face-to-face exercise therapy and has the advantage of supporting in home exercises because of the 24/7 accessibility. However, the lack of face-to-face contact with a professional is a disadvantage of web-based interventions and is probably one of the reasons for low adherence rates. In order to combine the best of two worlds, we have developed the intervention e-Exercise. In this blended intervention face-to-face contacts with a physical therapist are partially replaced by a web-based exercise intervention. The aim of this study is to investigate the short- (3 months) and long-term (12 months) (cost)-effectiveness of e-Exercise compared to usual care physical therapy. Our hypothesis is that e-Exercise is more effective and cost-effective in increasing physical functioning and physical activity compared to usual care. Methods/Design: This paper presents the protocol of a prospective, single-blinded, multicenter cluster randomized controlled trial. In total, 200 patients with OA of the hip and/or knee will be randomly allocated into either e-Exercise or usual care (physical therapy). E-Exercise is a 12-week intervention, consisting of maximum five face-to-face physical therapy contacts supplemented with a web-based program. The web-based program contains assignments to gradually increase patients' physical activity, strength and stability exercises and information about OA related topics. Primary outcomes are physical activity and physical functioning. Secondary outcomes are health related quality of life, self-perceived effect, pain, tiredness and self-efficacy. All measurements will be performed at baseline, 3 and 12 months after inclusion. Retrospective cost questionnaires will be sent at 3, 6, 9 and 12 months and used for the cost-effectiveness and cost-utility analysis. Discussion: This study is the first randomized controlled trial in the (cost)-effectiveness of a blended exercise intervention for patients with osteoarthritis of the hip and/or knee. The findings will help to improve the treatment of patients with osteoarthritis. [ABSTRACT FROM AUTHOR]

Background: Exercise therapy in patients with hip and/or knee osteoarthritis is effective in reducing pain, increasing physical activity and physical functioning, but costly and a burden for the health care budget. A web-based intervention is cheap in comparison to face-to-face exercise therapy and has the advantage of supporting in home exercises because of the 24/7 accessibility. However, the lack of face-to-face contact with a professional is a disadvantage of web-based interventions and is probably one of the reasons for low adherence rates. In order to combine the best of two worlds, we have developed the intervention e-Exercise. In this blended intervention face-to-face contacts with a physical therapist are partially replaced by a web-based exercise intervention. The aim of this study is to investigate the short- (3 months) and long-term (12 months) (cost)-effectiveness of e-Exercise compared to usual care physical therapy. Our hypothesis is that e-Exercise is more effective and cost-effective in increasing physical functioning and physical activity compared to usual care.Methods/design: This paper presents the protocol of a prospective, single-blinded, multicenter cluster randomized controlled trial. In total, 200 patients with OA of the hip and/or knee will be randomly allocated into either e-Exercise or usual care (physical therapy). E-Exercise is a 12-week intervention, consisting of maximum five face-to-face physical therapy contacts supplemented with a web-based program. The web-based program contains assignments to gradually increase patients' physical activity, strength and stability exercises and information about OA related topics. Primary outcomes are physical activity and physical functioning. Secondary outcomes are health related quality of life, self-perceived effect, pain, tiredness and self-efficacy. All measurements will be performed at baseline, 3 and 12 months after inclusion. Retrospective cost questionnaires will be sent at 3, 6, 9 and 12 months and used for the cost-effectiveness and cost-utility analysis.Discussion: This study is the first randomized controlled trial in the (cost)-effectiveness of a blended exercise intervention for patients with osteoarthritis of the hip and/or knee. The findings will help to improve the treatment of patients with osteoarthritis.Trial Registration: NTR4224. [ABSTRACT FROM AUTHOR]