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Introduction: Femoroacetabular impingement syndrome (FAIS) is a motion-related and position-related clinical condition of the hip associated with pain, reduced physical function and hip-related quality of life (QoL). Interestingly, higher maximal muscle strength is associated with less pain, better physical function and improved QoL in people with FAIS. Furthermore, preliminary evidence suggests that a proportion of patients with FAIS respond positively to strength exercise as first-line treatment. Nonetheless, there is little evidence supporting a specific exercise intervention offered as a first-line treatment. We will conduct a randomised controlled trial investigating the clinical effectiveness and cost-effectiveness of a 6-month strength exercise intervention compared with usual care as first-line treatment in patients with FAIS., Methods and Analysis: This is a multicentre randomised controlled trial that will be conducted at hospitals and physiotherapy clinics across Denmark and Australia. A total of 120 patients with FAIS will be randomised (1:1) to 6 months of supervised strength exercise or usual care. The primary outcome is the change in hip-related QoL measured using the International Hip and Outcome Tool 33 (iHOT-33) from baseline to the end of intervention. A health economic evaluation will be conducted from a societal and healthcare perspective based on the data collection over a 12-month period starting at baseline. The analysis will calculate incremental cost-effectiveness ratios using quality-adjusted life-years and iHOT-33 scores while estimating costs using microcosting and cost questionnaires. Secondary outcomes include objectively measured physical function at baseline and after 6 months and patient-reported outcomes measured at baseline, 3-month, 6-month and 12-month follow-up., Ethics and Dissemination: The trial has been approved by the Committee on Health Research Ethics in the Central Denmark Region (journal no 1-10-72-45-23) and La Trobe University Human Ethics Committee (HEC24042) and is registered at the Central Denmark Region List of Research Projects (journal no 1-16-02-115-23). Informed consent will be obtained from each participant before randomisation. Results will be published in international peer-reviewed scientific journals., Trial Registration Number: NCT05927935., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Surgery is not a viable treatment for all patients with hip dysplasia. Currently, usual care for these patients is limited to a consultation on self-management. We have shown that an exercise and patient education intervention is a feasible and acceptable intervention for patients not receiving surgery. Therefore, we aim to investigate whether patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain compared with those randomised to usual care over 6 months. Furthermore, we aim to evaluate the cost-effectiveness and perform a process evaluation., Methods and Analysis: In a randomised controlled trial, 200 young and middle-aged patients will be randomised to either exercise and patient education or usual care at a 1:1 ratio through permuted block randomisation. The intervention group will receive exercise instruction and patient education over 6 months. The usual care group will receive one consultation on self-management of hip symptoms. The primary outcome is the self-reported mean change in the pain subscale of the Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes include mean changes in the other HAGOS subscales, in the Short Version of the International Hip Outcome Tool, in performance, balance and maximal hip muscle strength. Between-group comparison from baseline to 6-month follow-up will be made with intention-to-treat analyses with a mixed-effects model. Cost-effectiveness will be evaluated by relating quality-adjusted life years and differences in HAGOS pain to differences in costs over 12 months. The functioning of the intervention will be evaluated as implementation, mechanisms of change and contextual factors., Ethics and Dissemination: The study protocol was approved by the Committee on Health Research Ethics in the Central Denmark Region and registered at ClinicalTrials. Positive, negative and inconclusive findings will be disseminated through international peer-reviewed scientific journals and international conferences., Trial Registration Number: NCT04795843., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: C-reactive protein point-of-care testing (CRP POCT) is a promising diagnostic tool to guide antibiotic prescribing for lower respiratory tract infections (LRTI) in nursing home residents. This study aimed to evaluate cost-effectiveness and return-on-investment (ROI) of CRP POCT compared with usual care for nursing home residents with suspected LRTI from a healthcare perspective., Design: Economic evaluation alongside a cluster randomised, controlled trial., Setting: 11 Dutch nursing homes., Participants: 241 nursing home residents with a newly suspected LRTI., Intervention: Nursing home access to CRP POCT (POCT-guided care) was compared with usual care without CRP POCT (usual care)., Main Outcome Measures: The primary outcome measure for the cost-effectiveness analysis was antibiotic prescribing at initial consultation, and the secondary outcome was full recovery at 3 weeks. ROI analyses included intervention costs, and benefits related to antibiotic prescribing. Three ROI metrics were calculated: Net Benefits, Benefit-Cost-Ratio and Return-On-Investment., Results: In POCT-guided care, total costs were on average €32 higher per patient, the proportion of avoided antibiotic prescribing was higher (0.47 vs 0.18; 0.30, 95% CI 0.17 to 0.42) and the proportion of fully recovered patients statistically non-significantly lower (0.86 vs 0.91; -0.05, 95% CI -0.14 to 0.05) compared with usual care. On average, an avoided antibiotic prescription was associated with an investment of €137 in POCT-guided care compared with usual care. Sensitivity analyses showed that results were relatively robust. Taking the ROI metrics together, the probability of financial return was 0.65., Conclusion: POCT-guided care effectively reduces antibiotic prescribing compared with usual care without significant effects on recovery rates, but requires an investment. Future studies should take into account potential beneficial effects of POCT-guided care on costs and health outcomes related to antibiotic resistance., Trial Registration Number: NL5054., Competing Interests: Competing interests: The authors declare: LWvB, TMB, MEA, JB and CMPMH report a grant from The Netherlands Organisation for Health Research and Development (ZonMw), for the conduct of the current study. RH receives no support from any organisation for the submitted work. MWvT reports grants from The Netherlands Organisation for Health Research and Development (ZonMw), outside the submitted work. TJMV reports grants from Abbott, Becton Dickinson, Biomerieux, European Commission; grants from European Commission, Orion, during the conduct of the study; grants from European Commission, Janssen Pharmaceuticals; and grants from ZonMw, outside the submitted work., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Low back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control)., Methods and Analysis: A pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective., Ethics and Dissemination: Approved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations., Trial Registration Number: ACTRN12619001134112., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Intermittent neurogenic claudication (INC) is often caused by lumbar spinal stenosis (LSS). Laminectomy is considered a frequently used surgical technique for LSS. Previous studies have shown that laminectomy can potentially cause lumbar instability. Less invasive techniques, preserving midline structures including the bilateral small size interarcuair decompression, are currently applied. Due to lack of evidence and consensus, surgeons have to rely on their training and own experiences to choose the best surgical techniques for their patients. Hence, an observer and patient blinded multicentre, randomised controlled trial was designed to determine the effectiveness and cost-effectiveness of bilateral interarcuair decompression versus laminectomy for LSS., Methods and Analysis: 174 patients above 40 years with at least 12 weeks of INC will be recruited. Patients are eligible for inclusion if they have a clinical indication for surgery for INC with an MRI showing signs of LSS. Patients will be randomised to laminectomy or bilateral interarcuair decompression. The primary outcome is functional status measured with the Roland-Morris Disability Questionnaire at 12 months. Secondary outcomes consist of pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination. Outcome measurement moments will be scheduled at 3 and 6 weeks, and at 3, 6, 12, 18, 24, 36 and 48 months after surgery. Physical examination will be performed at 6 weeks, and 12, 24 and 48 months. An economic evaluation will be performed and questionnaires will be used to collect cost data., Ethics and Dissemination: The Medical Ethical Committee of the Erasmus Medical Centre Rotterdam approved this study (NL.65826.078.18). The results will be published in an international peer-reviewed journal., Trial Registration Number: ClinicalTrials.gov (NCT03480893)., Irb Approval Status: MEC-2018-093., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Objective: To assess the cost effectiveness of a reduced imaging follow-up protocol of distal radius fractures compared with usual care., Design: An economical evaluation conducted alongside a multicentre randomised controlled trial (RCT)., Setting: Four level-one trauma centres in the Netherlands., Participants: 341 patients participated (usual care (n=172), reduced imaging (n=169))., Interventions: Patients were randomised to usual care (routine radiography at 1, 2, 6 and 12 weeks) or a reduced imaging strategy (radiographs at 6 and 12 weeks only for a clinical indication)., Outcome Measures: Functional outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and quality-adjusted life years (QALYs) using the EuroQol-5Dimensions-3 Levels (EQ-5D-3L). Costs were measured using self-reported questionnaires and medical records, and analysed from a societal perspective. Multiple imputation, seemingly unrelated regression analysis and bootstrapping were used to analyse the data., Results: Clinical overall outcomes of both groups were comparable. The difference in DASH was -2.03 (95% CI -4.83 to 0.77) and the difference in QALYs was 0.025 (95% CI -0.01 to 0.06). Patients in the reduced imaging group received on average 3.3 radiographs (SD: 1.9) compared with 4.2 (SD: 1.9) in the usual care group. Costs for radiographic imaging were significantly lower in the reduced imaging group than in the usual care group (€-48 per patient, 95% CI -68 to -27). There was no difference in total costs between groups (€-401 per patient, 95% CI -2453 to 1251). The incremental cost-effectiveness ratio (ICER) for QALYs was -15 872; the ICER for the DASH was 198. The probability of reduced imaging being cost effective compared with usual care ranged from 0.8 to 0.9 at a willingness to pay of €20 000/QALY to €80 000/QALY., Conclusions: Implementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome. We, therefore, recommend imaging only when clinically indicated., Trial Registration Number: The Netherlands trial register (NL4477)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To evaluate the cost-utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study., Design: A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial., Setting: Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect., Participants: 180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91)., Interventions: Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days., Main Outcome Measures: Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER)., Results: Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; -3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%., Conclusions: Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up., Trial Registration Number: ClinicalTrials.gov NCT02323412., Competing Interests: Competing interests: KS reports that funding was granted by governmental organisations (Helse Sør-Øst and Helse Vest) during the conduct of the study., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Major depressive disorders (MDD), diabetes mellitus type 2 (DM2) and coronary heart disease (CHD) are leading contributors to the global burden of disease and often co-occur., Objectives: To evaluate the 2-year effectiveness of a stepped-care intervention to prevent MDD compared with usual care and to develop a prediction model for incident depression in patients with DM2 and/or CHD with subthreshold depression., Methods: Data of 236 Dutch primary care patients with DM2/CHD with subthreshold depression (Patient Health Questionnaire 9 (PHQ-9) score ≥6, no current MDD according to the Mini International Neuropsychiatric Interview (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria)) who participated in the Step-Dep trial were used. A PHQ-9 score of ≥10 at minimally one measurement during follow-up (at 3, 6, 9, 12 and 24 months) was used to determine the cumulative incidence of MDD. Potential demographic and psychological predictors were measured at baseline via web-based self-reported questionnaires and evaluated using a multivariable logistic regression model. Model performance was assessed with the Hosmer-Lemeshow test, Nagelkerke's R 2 explained variance and area under the receiver operating characteristic curve (AUC). Bootstrapping techniques were used to internally validate our model., Results: 192 patients (81%) were available at 2-year follow-up. The cumulative incidence of MDD was 97/192 (51%). There was no statistically significant overall treatment effect over 24 months of the intervention (OR 1.37; 95% CI 0.52 to 3.55). Baseline levels of anxiety, depression, the presence of >3 chronic diseases and stressful life events predicted the incidence of MDD (AUC 0.80, IQR 0.79-0.80; Nagelkerke's R 2 0.34, IQR 0.33-0.36)., Conclusion: A model with 4 factors predicted depression incidence during 2-year follow-up in patients with DM2/CHD accurately, based on the AUC. The Step-Dep intervention did not influence the incidence of MDD. Future depression prevention programmes should target patients with these 4 predictors present, and aim to reduce both anxiety and depressive symptoms., Trial Registration Number: NTR3715., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Lumbosacral radicular syndrome is often caused by a disc herniation. The standard surgical technique to remove a disc herniation is open microdiscectomy. An alternative technique is percutaneous transforaminal endoscopic discectomy (PTED), which is less invasive. In the Netherlands, PTED is not currently considered as standard care, and therefore not reimbursed within public health insurance. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the effectiveness and cost-effectiveness of PTED versus open microdiscectomy for the treatment of lumbar disc herniation., Method and Analysis: In total, 682 patients between 18 and 70 years of age with >10 weeks of radiating pain or with >6 weeks of excessive radiating pain are to be recruited from participating centres. Patients must have an indication for surgery based on an MRI demonstrating compression of the nerve root from a lumbar disc herniation. Patients are to be randomised to PTED or open microdiscectomy. The primary outcome is self-reported leg pain measured by the 0-100 mm Visual Analogue Scale. Secondary outcomes include self-reported health and functional status, back pain, self-perceived recovery and a physical examination. Outcomes will be measured the day following surgery, at 2, 4 and 6 weeks, and at 3, 6, 9, 12 and 24 months. Physical examination will be performed at 6 weeks, and 3 and 12 months. An economic evaluation will be performed from a societal perspective and cost questionnaires will be used (eg, EQ-5D-5L). The data will be analysed longitudinally; the non-inferiority margin for the primary outcome is 5. Bootstrapping techniques will be used for the economic evaluation., Ethics and Dissemination: This study has received approval of the Medical Ethical Committee of the VU Medical Centre Amsterdam: NL50951.029.14. The results will be published in an international peer-reviewed scientific journal., Trial Registration Number: NCT02602093; Pre-results, recruiting stage., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Recent studies show similar outcome between surgery and conservative treatment in patients with non-obstructive meniscal tears. However, surgery is still often preferred over conservative treatment. When conservative treatment is non-inferior to surgery, shifting the current standard treatment choice to conservative treatment alone could save over €30 millions of direct medical costs on an annual basis. Economic evaluation studies comparing surgery to conservative treatment are lacking., Methods and Analysis: A multicentre randomised controlled trial (RCT) with an economic evaluation alongside was performed to assess the (cost)-effectiveness of surgery and conservative treatment for meniscal tears. We will include 402 participants between 45 and 70 years with an MRI-confirmed symptomatic, non-obstructive meniscal tears to prove non-inferiority of conservative treatment. Block randomisation will be web-based. The primary outcome measure is a physical function, measured by the International Knee Documentation Committee 'Subjective Knee Form'. Furthermore, we will perform a cost-effectiveness and cost-utility analysis from societal perspective and a budget impact analysis from a societal, government and insurer perspective. Secondary outcomes include general health, quality of life, activity level, knee pain, physical examination, progression of osteoarthritis and the occurrence of adverse events., Ethics and Dissemination: This RCT will be performed in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee (number NL44188.100.13). The results of this study will be reported in peer-reviewed journals and at international conferences. We further aim to disseminate our results to guideline committees., Trial Registration Number: NCT01850719., Competing Interests: Conflicts of Interest: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)