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Background: A Dutch nationwide prospective cohort study was initiated to investigate recovery trajectories of people recovering from coronavirus disease 2019 (COVID-19) and costs of treatment by primary care allied health professionals., Objectives: The study described recovery trajectories over a period of 12 months and associated baseline characteristics of participants recovering from COVID-19 who visited a primary care allied health professional. It also aimed to provide insight into the associated healthcare and societal costs., Methods: Participants completed participant-reported standardized outcomes on participation, health-related quality of life, fatigue, physical functioning, and costs at baseline (ie, start of the treatment), 3, 6, 9 and 12 months., Results: A total of 1451 participants (64 % women, 76 % mild/moderate severity) with a mean (SD) age of 49 (12) years were included. Linear mixed models showed significant and clinically relevant improvements over time in all outcome measures between baseline and 12 months. Between 6 and 12 months, we found significant but not clinically relevant improvements in most outcome measures. Having a worse baseline score was the only baseline factor that was consistently associated with greater improvement over time on that outcome. Total allied healthcare costs (mean €1921; SEM €48) made up about 3% of total societal costs (mean €64,584; SEM €3149) for the average participant in the cohort., Conclusions: The health status of participants recovering from COVID-19 who visited an allied health professional improved significantly over a 12-month follow-up period, but nearly the improvement occurred between baseline and 6 months. Most participants still reported severe impairments in their daily lives, and generated substantial societal costs. These issues, combined with the fact that baseline characteristics explained little of the variance in recovery over time, underscore the importance of continued attention for the management of people recovering from COVID-19., Trial Registration: clinicaltrials.gov (NCT04735744)., Competing Interests: Declaration of competing interest None., (Copyright © 2024 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)

Purpose: Multiple studies have explored the needs and experiences of patients, family members, and healthcare professionals regarding hospital-to-home transitions. Our study aimed to identify, critically appraise, and summarize these studies in a qualitative meta-synthesis., Materials and Methods: Medline, CINAHL and Embase were systematically searched to identify eligible articles from inception to June 2024. Qualitative studies were included and critically appraised using the Critical Appraisal Skills Program. Insufficient-quality papers were excluded. We performed a meta-synthesis following (1) open coding by two independent researchers and (2) discussing codes during reflexivity meetings., Results: Ninety-eight studies were appraised, of which 53 were included. We reached thematic saturation, four themes were constructed: (1) care coordination and continuity, (2) communication, (3) patient and family involvement, and (4) individualized support and information exchange. For patients and families, tailored information and support are prerequisites for a seamless transition and an optimal recovery trajectory after hospital discharge. It is imperative that healthcare professionals communicate effectively within and across care settings to ensure multidisciplinary collaboration and care continuity., Conclusions: This study identifies essential elements of optimal transitional care. These findings could be supportive to researchers and healthcare professionals when (re)designing transitional care interventions to ensure care continuity after hospital discharge.

Background: Recurrence of low back pain is common and a substantial contributor to the disease and economic burden of low back pain. Exercise is recommended to prevent recurrence, but the effectiveness and cost-effectiveness of an accessible and low-cost intervention, such as walking, is yet to be established. We aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain., Methods: WalkBack was a two-armed, randomised controlled trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112)., Findings: Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60-0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149-295) in the intervention group and 112 days (89-140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group)., Interpretation: An individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed., Funding: National Health and Medical Research Council, Australia., Competing Interests: Declaration of interests The Australia & New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network endorsed the WalkBack trial. NCP was on scholarships during her PhD candidature, which were funded by the National Health and Medical Research Council Low Back Pain Centre of Research Excellence (ANZBACK) and Macquarie University (Sydney, Australia). C-WCL and CGM are supported by National Health and Medical Research Council fellowships (APP1193939, awarded to C-WCL; and APP1194283, awarded to CGM). All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background and Purpose: Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression and surgical complications. Consensus exists to avoid inappropriate use of radiographs in children. It is unknown whether a standard radiologic follow-up (S-FU) approach is necessary or if a patient-empowered follow-up (PE-FU) approach can reduce the number of radiographs without treatment consequences., Methods and Analyses: A nationwide multicenter pragmatic randomized preference trial was designed for 3 follow-up subgroups (pre-treatment, post-brace, post-surgery) to compare PE-FU and S-FU. 812 patients with AIS (age 10-18 years) will be included in the randomized trial or preference cohorts. Primary outcome is the proportion of radiographs with a treatment consequence for each subgroup. Secondary outcomes consist of the proportion of patients with delayed initiation of treatment due to non-routine radiographic follow-up, radiation exposure, societal costs, positive predictive value, and interrelation of clinical assessment, quality of life, and parameters for initiation of treatment during follow-up. Outcomes will be analyzed using linear mixed-effects models, adjusted for relevant baseline covariates, and are based on intention-to-treat principle. Study summary: (i) a national, multicenter pragmatic randomized trial addressing the optimal frequency of radiographic follow-up in patients with AIS; (ii) first study that includes patient-empowered follow-up; (iii) an inclusive study with 3 follow-up subgroups and few exclusion criteria representative for clinical reality; (iv) preference cohorts alongside to amplify generalizability; (v) first study conducting an economic evaluation comparing both follow-up approaches.

Rationale: Cervical radiculopathy is initially typically managed conservatively. Surgery is indicated when conservative management fails or with severe/progressive neurological signs. Personalised multimodal physiotherapy could be a promising conservative strategy. However, aggregated evidence on the (cost-)effectiveness of personalised multimodal physiotherapy compared to surgery with/without post-operative physiotherapy is lacking., Aim/objectives: To systematically summarise the literature on the (cost-)effectiveness of personalised multimodal physiotherapy compared to surgery with or without post-operative physiotherapy in patients with cervical radiculopathy., Methods: PubMed, Embase, CINAHL, PsycINFO and Web of Science were searched from inception to 1st of March 2023. Primary outcomes were effectiveness regarding costs, arm pain intensity and disability. Neck pain intensity, perceived recovery, quality of life, neurological symptoms, range-of-motion, return-to-work, medication use, (re)surgeries and adverse events were considered secondary outcomes. Randomised clinical trials comparing personalised multimodal physiotherapy versus surgical approaches with/without post-operative physiotherapy were included. Two independent reviewers performed study selection, data-extraction, and risk of bias assessment using the Cochrane RoB 2 and Consolidated Health Economic Evaluation Reporting Standards statement. Certainty of the evidence was determined using Grading of Recommendations, Assessment, Development and Evaluations., Results: From 2109 records, eight papers from two original trials, with 117 participants in total were included. Low certainty evidence showed there were no significant differences on arm pain intensity and disability, except for the subscale 'heavy work' related disability (12 months) and disability at 5-8 years. Cost-effectiveness was not assessed. There was low certainty evidence that physiotherapy improved significantly less on neck pain intensity, sensory loss and perceived recovery compared to surgery with/without physiotherapy. Low certainty evidence showed there were no significant differences on numbness, range of motion, medication use, and quality of life. No adverse events were reported., Conclusion: Considering the clinical importance of accurate management recommendations and the current low level of certainty, high-quality cost-effectiveness studies are needed., (© 2024 The Author(s). Journal of Evaluation in Clinical Practice published by John Wiley & Sons Ltd.)

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)., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

Abstract: 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 = €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., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)

Objective: Transforaminal epidural steroid injections (TESIs) are widely administered for sciatica. The aim of this trial was to evaluate the effectiveness of TESIs in patients with acute sciatica (<8 wk)., Methods: This study was conducted in 2 Dutch hospitals. Participants (n=141) were randomly assigned to (1) usual care and TESI of 1 ml of 40 mg/ml Methylprednisolone plus 1 ml of 0.5% Levobupivacaine (intervention 1); (2) usual care and transforaminal epidural injection with 1 ml of 0.5% Levobupivacaine and 1 ml NaCl 0.9% (intervention 2); (3) usual care consisting of oral pain medication with or without physiotherapy (control). Co-primary outcomes were back pain and leg pain intensity, physical functioning, and recovery measured during 6-month follow-up., Results: There were no statistically significant mean differences in co-primary outcomes between groups during follow-up, except for leg pain when comparing intervention group 1 with control (-0.96 95%CI:-1.83 to -0.09). For secondary outcomes, some statistical significant between-group differences were found for treatment satisfaction and surgery, but only when comparing intervention group 2 to control. Post hoc analyses showed a statistically significant difference in response [50% improvement of leg pain (yes/no)] between intervention 1 and the control group at 3 months and that both intervention groups used less opioids., Discussion: Except for a statistically significant effect of TESI on leg pain for patients with acute sciatica compared with usual care, there were no differences in co-primary outcomes. Nonetheless, transforaminal epidural injections seem to be associated with less opioid use, which warrants further exploration., Competing Interests: The authors declare no conflict of interest, (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: 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., Objective: 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., Methods: 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., Results: 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., Conclusions: 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., Trial Registration: ISRCTN 94074203; https://www.isrctn.com/ISRCTN94074203., International Registered Report Identifier (irrid): RR2-10.1186/s12891-020-3174-z., (©Tjarco Koppenaal, Johanna M van Dongen, Corelien JJ Kloek, Remco M Arensman, Cindy Veenhof, Martijn F Pisters, Raymond WJG Ostelo. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 24.11.2023.)

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., (© 2023. The Author(s).)

Purpose: Inconsistent results have been found on the impact of using crosswalks versus EQ-5D value sets on reimbursement decisions. We sought to further investigate this issue in a simulation study., Methods: Trial-based economic evaluation data were simulated for different conditions (depression, low back pain, osteoarthritis, cancer), severity levels (mild, moderate, severe), and effect sizes (small, medium, large). For all 36 scenarios, utilities were calculated using 3L and 5L value sets and crosswalks (3L to 5L and 5L to 3L crosswalks) for the Netherlands, the United States, and Japan. Utilities, quality-adjusted life years (QALYs), incremental QALYs, incremental cost-effectiveness ratios (ICERs), and probabilities of cost-effectiveness (pCE) obtained from values sets and crosswalks were compared., Results: Differences between value sets and crosswalks ranged from -0.33 to 0.13 for utilities, from -0.18 to 0.13 for QALYs, and from -0.01 to 0.08 for incremental QALYs, resulting in different ICERs. For small effect sizes, at a willingness-to-pay of €20,000/QALY, the largest pCE difference was found for moderate cancer between the Japanese 5L value set and 5L to 3L crosswalk (difference = 0.63). For medium effect sizes, the largest difference was found for mild cancer between the Japanese 3L value set and 3L to 5L crosswalk (difference = 0.06). For large effect sizes, the largest difference was found for mild osteoarthritis between the Japanese 3L value set and 3L to 5L crosswalk (difference = 0.08)., Conclusion: The use of crosswalks instead of EQ-5D value sets can impact cost-utility outcomes to such an extent that this may influence reimbursement decisions., (© 2022. The Author(s).)

Abstract: Shoulder disorders are common and associated with high societal costs, especially for a small group of patients. Prognostic factors can help identify high-cost patients, which is crucial to optimize early identification and develop tailored interventions. We aimed to identify prognostic factors for high societal costs, to examine whether the prognostic factors were similar for high healthcare costs and high costs of sick leave, and to investigate the model's robustness across 4 diagnostic categories. Using national Danish registers, potential prognostic factors (age, sex, educational level, long-term sick leave, admission, visits to general practitioner and physiotherapist, comorbidity, diabetes, low back pain, and neck pain) were included in a logistic regression model with high societal costs, defined by the top 10th percentile, as the main outcome. The model's prognostic accuracy was assessed using the Nagelkerke R2 and its discriminative ability using area under the receiver operating curve (AUC). Data on 80% of the patients (n = 449,302) were used to develop the model and 20% (n = 112,363) to validate the model. By far the strongest prognostic factor for high societal costs and high costs of sick leave was sick leave at the time of diagnosis (OR: 20.2, 95% CI: 19.5-20.9). Prognostic factors for high healthcare costs were high age, comorbidity, and hospital admission the year before diagnosis. The model was robust across diagnostic categories and sensitivity analyses. In the validation sample, the primary model's discriminative ability was good (AUC = 0.80) and the model explained 28% of the variation in the outcome (Nagelkerke R2 )., (Copyright © 2023 International Association for the Study of Pain.)

Introduction: Appropriate treatment for people with an increased risk for developing chronic Persistent Somatic Symptoms (PSS) is of great importance at an early stage to improve quality of life and prevent high costs for society., Objective: To evaluate the cost-effectiveness of an integrated blended care intervention compared to usual care for QALYs, subjective symptom impact and physical and mental health status in patients with moderate PSS., Methods: This economic evaluation was conducted alongside a 12-month prospective, multicenter cluster randomized controlled trial in Dutch primary care. 80 participants received the intervention and 80 participants received usual care. Seemingly unrelated regression analyzes were performed to estimate cost and effect differences. Missing data were imputed using multiple imputation. Bootstrapping techniques were used to estimate uncertainty., Results: We found no significant difference in total societal costs. Intervention, primary and secondary healthcare and absenteeism costs were higher for the intervention group. The ICER for QALYs demonstrated the intervention was on average less costly and less effective compared to usual care. For the subjective symptom impact and physical health, the ICER indicated that the intervention group was on average less costly and more effective. For mental health, the intervention was on average more costly and less effective., Conclusion: We didn't find an integrated blended primary care intervention to be cost-effective compared to usual care. However, when looking on relevant, but specific outcome measures (subjective symptom impact and physical health) for this population, average costs are found to be lower and the effectiveness found to be higher., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: For the analysis of clinical effects, multiple imputation (MI) of missing data were shown to be unnecessary when using longitudinal linear mixed-models (LLM). It remains unclear whether this also applies to trial-based economic evaluations. Therefore, this study aimed to assess whether MI is required prior to LLM when analyzing longitudinal cost and effect data., Methods: Two-thousand complete datasets were simulated containing five time points. Incomplete datasets were generated with 10, 25, and 50% missing data in follow-up costs and effects, assuming a Missing At Random (MAR) mechanism. Six different strategies were compared using empirical bias (EB), root-mean-squared error (RMSE), and coverage rate (CR). These strategies were: LLM alone (LLM) and MI with LLM (MI-LLM), and, as reference strategies, mean imputation with LLM (M-LLM), seemingly unrelated regression alone (SUR-CCA), MI with SUR (MI-SUR), and mean imputation with SUR (M-SUR)., Results: For costs and effects, LLM, MI-LLM, and MI-SUR performed better than M-LLM, SUR-CCA, and M-SUR, with smaller EBs and RMSEs as well as CRs closers to nominal levels. However, even though LLM, MI-LLM and MI-SUR performed equally well for effects, MI-LLM and MI-SUR were found to perform better than LLM for costs at 10 and 25% missing data. At 50% missing data, all strategies resulted in relatively high EBs and RMSEs for costs., Conclusion: LLM should be combined with MI when analyzing trial-based economic evaluation data. MI-SUR is more efficient and can also be used, but then an average intervention effect over time cannot be estimated., (© 2022. The Author(s).)

Introduction: Lifestyle factors are expected to contribute to the persistence and burden of low-back pain (LBP). However, there are no systematic reviews on the (cost-)effectiveness of combined lifestyle interventions for overweight or obese people with LBP., Aim: To assess whether combined lifestyle interventions are (cost-)effective for people with persistent LBP who are overweight or obese, based on a systematic review., Design: Systematic review METHOD: PubMed, Cochrane, Embase, CINAHL, PsycINFO and the Wiley/Cochrane Library were searched from database inception till January 6 th 2023. Two independent reviewers performed study selection, data-extraction and risk of bias scoring using the Cochrane RoB tool 2 and/or the Consensus Health Economic Criteria list. GRADE was used to assess the level of certainty of the evidence., Results: In total 2510 records were screened, and 4 studies on 3 original RCTs with 216 participants were included. Low certainty evidence (1 study) showed that combined lifestyle interventions were not superior to usual care for physical functioning, pain and lifestyle outcomes. Compared to usual care, moderate certainty evidence showed that healthcare (-$292, 95%CI: 872; -33), medication (-$30, 95% CI -65; -4) and absenteeism costs (-$1000, 95%CI: 3573; -210) were lower for the combined lifestyle interventions., Conclusion: There is low certainty evidence from 3 studies with predominantly small sample sizes, short follow-up and low intervention adherence that combined lifestyle interventions are not superior to physical functioning, pain and lifestyle outcomes compared to usual care, but are likely to be cost-effective., Competing Interests: Declaration of competing interest None., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives: To develop and validate approaches for mapping Oswestry Disability Index responses to 3-level version of EQ-5D utility values and to evaluate the impact of using mapped utility values on cost-utility results compared with published regression models., Methods: Three response mapping approaches were developed in a random sample of 70% of 18 692 patients with low back pain: nonparametric approach (Non-p), nonparametric approach excluding logical inconsistencies (Non-peLI), and ordinal logistic regression (OLR). Performance was assessed in the remaining 30% using R-square (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., Results: 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)., Conclusions: Results suggest that the developed response mapping approaches are not valid for estimating individual patients' 3-level version of EQ-5D utility values, and-depending on the approach-may considerably affect cost-utility results. The developed approaches did not perform better than previously published regression-based models and are therefore not recommended for use in economic evaluations., (Copyright © 2023. Published by Elsevier Inc.)

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., (© 2023. The Author(s).)

Background: With the worldwide rising obesity epidemic and the aging population, it is essential to deliver (cost-)effective care that results in enhanced societal participation among knee arthroplasty patients. The purpose of this study is to describe the development, content, and protocol of our (cost-)effectiveness study that assesses a perioperative integrated care program, including a personalized eHealth app, for knee arthroplasty patients aimed to enhance societal participation post-surgery compared to care as usual., Methods: The intervention will be tested in a multicentre randomized controlled trial with eleven participating Dutch medical centers (i.e., hospitals and clinics). Working patients on the waiting-list for a total- or unicompartmental knee arthroplasty with the intention to return to work after surgery will be included. After pre-stratification on medical centre with or without eHealth as usual care, operation procedure (total- or unicompartmental knee arthroplasty) and recovery expectations regarding return to work, randomization will take place at the patient-level. A minimum of 138 patients will be included in both the intervention and control group, 276 in total. The control group will receive usual care. On top of care as usual, patients in the intervention group will receive an intervention consisting of three components: 1) a personalized eHealth intervention called ikHerstel ('I Recover') including an activity tracker, 2) goal setting using goal attainment scaling to improve rehabilitation and 3) a referral to a case-manager. Our main outcome is quality of life, based on patient-reported physical functioning (using PROMIS-PF). (Cost-)effectiveness will be assessed from a healthcare and societal perspective. Data collection has been started in 2020 and is expected to finish in 2024., Discussion: Improving societal participation for knee arthroplasty is relevant for patients, health care providers, employers and society. This multicentre randomized controlled trial will evaluate the (cost-)effectiveness of a personalized integrated care program for knee arthroplasty patients, consisting of effective intervention components based on previous studies, compared to care as usual., Trial Registration: Trialsearch.who.int; reference no. NL8525, reference date version 1: 14-04-2020., (© 2023. The Author(s).)

The aim of this article was to perform a scoping review of methods available for dealing with confounding when analyzing the effect of health care treatments with single-point exposure in observational data. We aim to provide an overview of methods and their performance assessed by simulation studies indexed in PubMed. We searched PubMed for simulation studies published until January 2021. Our search was restricted to studies evaluating binary treatments and binary and/or continuous outcomes. Information was extracted on the methods' assumptions, performance, and technical properties. Of 28,548 identified references, 127 studies were eligible for inclusion. Of them, 84 assessed 14 different methods (ie, groups of estimators that share assumptions and implementation) for dealing with measured confounding, and 43 assessed 10 different methods for dealing with unmeasured confounding. Results suggest that there are large differences in performance between methods and that the performance of a specific method is highly dependent on the estimator. Furthermore, the methods' assumptions regarding the specific data features also substantially influence the methods' performance. Finally, the methods result in different estimands (ie, target of inference), which can even vary within methods. In conclusion, when choosing a method to adjust for measured or unmeasured confounding it is important to choose the most appropriate estimand, while considering the population of interest, data structure, and whether the plausibility of the methods' required assumptions hold., (© 2022 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.)

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/m 2 ) 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., (© 2023. The Author(s).)

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.