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Background and Purpose: Concerns exist regarding the generalizability of results from randomized controlled trials (RCTs) evaluating arthroscopic partial meniscectomy (APM) to treat degenerative meniscus tears. It has been suggested that study populations are not representative of subjects selected for surgery in daily clinical practice. Therefore, we aimed to compare patients included in trials and prospective cohort studies that received APM for a degenerative meniscus tear., Patients and Methods: Individual participant data from 4 RCTs and 2 cohort studies undergoing APM were collected. 1,970 patients were analyzed: 605 patients included in RCTs and 1,365 included in the cohorts. We compared patient and disease characteristics, knee pain, overall knee function, and health-related quality of life at baseline between the RCT and cohort groups using standardized differences, ratios comparing the variance of continuous covariates, and graphical methods such as quantile-quantile plots, side-by-side boxplots, and non-parametric density plots., Results: Differences between RCT and the cohort were observed primarily in age (younger patients in the cohort; standardized difference: 0.32) and disease severity, with the RCT group having more severe symptoms (standardized difference: 0.38). While knee pain, overall knee function, and quality of life generally showed minimal differences between the 2 groups, it is noteworthy that the largest observed difference was in knee pain, where the cohort group scored 7 points worse (95% confidence interval 5-9, standardized difference: 0.29)., Conclusion: Patients in RCTs were largely representative of those in cohort studies regarding baseline scores, though variations in age and disease severity were observed. Younger patients with less severe osteoarthritis were more common in the cohort; however, trial participants still appear to be broadly representative of the target population.

Objective: To identify subgroups of patients with magnetic resonance imaging (MRI)-confirmed degenerative meniscus tears who may benefit from arthroscopic partial meniscectomy (APM) in comparison with non-surgical or sham treatment., Methods: Individual participant data (IPD) from four RCTs were pooled (605 patients, mean age: 55 (SD: 7.5), 52.4% female) as to investigate the effectiveness of APM in patients with MRI-confirmed degenerative meniscus tears compared to non-surgical or sham treatment. Primary outcomes were knee pain, overall knee function, and health-related quality of life, at 24 months follow-up (0-100). The IPD were analysed in a one- and two-stage meta-analyses. Identification of potential subgroups was performed by testing interaction effects of predefined patient characteristics (e.g., age, gender, mechanical symptoms) and APM for each outcome. Additionally, generalized linear mixed-model trees were used for subgroup detection., Results: The APM group showed a small improvement over the non-surgical or sham group on knee pain at 24 months follow-up (2.5 points (95% CI: 0.8-4.2) and 2.2 points (95% CI: 0.9-3.6), one- and two-stage analysis, respectively). Overall knee function and health-related quality of life did not differ between the two groups. Across all outcomes, no relevant subgroup of patients who benefitted from APM was detected. The generalized linear mixed-model trees did also not identify a subgroup., Conclusions: No relevant subgroup of patients was identified that benefitted from APM compared to non-surgical or sham treatment. Since we were not able to identify any subgroup that benefitted from APM, we recommend a restrained policy regarding meniscectomy in patients with degenerative meniscus tears., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Purpose: In the Netherlands yearly more than 5000 patients are diagnosed with non-muscle invasive bladder cancer (NMIBC). With a specificity of 88.0% and a negative predictive value (NPV) for high grade NMIBC of 99.3%, the Bladder EpiCheck (BE) urine test may be used in NMIBC to reduce the burden of follow-up cystoscopies., Methods: In this study a cost analysis of the BE follow-up strategy in the Dutch healthcare system was performed. In half of the follow-up appointments, BE was used as a rule-in for cystoscopy. In addition, the possible delay in recurrence detection was estimated. A cost calculation tool was developed using Microsoft Excel., Results: The BE strategy results in an estimated cost reduction of 8%, 4% and 9% in low, intermediate and high risk patients, respectively. In the Netherlands this may result in a cost reduction of approximately 1.6 million euro per year. The estimated delay in the detection of recurrent disease would be 3.9, 1.7 and 1.3 months in low, intermediate and high risk NMIBC patients respectively., Conclusion: To conclude, the BE can be used to reduce the costs of NMIBC follow-up, with a small delay in diagnosis of recurrent disease., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Aims: Numerous studies have shown that arthroscopic partial meniscectomy (APM) is not (cost-) effective in patients with symptoms attributed to a degenerative meniscus tear. We aimed to assess the budget impact of reducing APM in routine clinical practice in this population., Materials and Methods: A patient-level state transition model was developed to simulate patients recently diagnosed with a degenerative meniscus tear. Three strategies were compared: "current guideline" (i.e., postpone surgery to at least 3 months after diagnosis), "APM at any time" (i.e., APM available directly after diagnosis), and "nonsurgical" (i.e., APM no longer performed). Total societal costs over 5 years were calculated to determine the budget impact. Probabilistic and deterministic sensitivity analyses were conducted to address uncertainty., Results: The average cost per patient over 5 years were EUR 5,077, EUR 4,577, and EUR 4,218, for the "APM at any time," "current guideline," and "nonsurgical" strategy, respectively. Removing APM from the treatment mix (i.e., 30,000 patients per year) in the Netherlands, resulted in a reduction in health care expenditures of EUR 54 million (95 percent confidence interval [CI] EUR 38 million-EUR 70 million) compared to the "current guideline strategy" and EUR 129 million (95 percent CI EUR 102 million-EUR 156 million) compared to the "APM at any time" strategy. Sensitivity analyses showed that uncertainty did not alter our conclusions., Conclusions: Substantial costs can be saved when APM is no longer performed to treat symptoms attributed to degenerative meniscus tears in the Netherlands. It is therefore recommended to further reduce the use of APM to treat degenerative meniscus tears.

Objective: To develop a prioritisation framework to support priority setting for elective surgeries after COVID-19 based on the impact on patient well-being and cost., Design: We developed decision analytical models to estimate the consequences of delayed elective surgical procedures (eg, total hip replacement, bariatric surgery or septoplasty)., Setting: The framework was applied to a large hospital in the Netherlands., Outcome Measures: Quality measures impacts on quality of life and costs were taken into account and combined to calculate net monetary losses per week delay, which quantifies the total loss for society expressed in monetary terms. Net monetary losses were weighted by operating times., Results: We studied 13 common elective procedures from four specialties. Highest loss in quality of life due to delayed surgery was found for total hip replacement (utility loss of 0.27, ie, 99 days lost in perfect health); the lowest for arthroscopic partial meniscectomy (utility loss of 0.05, ie, 18 days lost in perfect health). Costs of surgical delay per patient were highest for bariatric surgery (€31/pp per week) and lowest for arthroscopic partial meniscectomy (-€2/pp per week). Weighted by operating room (OR) time bariatric surgery provides most value (€1.19/pp per OR minute) and arthroscopic partial meniscectomy provides the least value (€0.34/pp per OR minute). In a large hospital the net monetary loss due to prolonged waiting times was €700 840 after the first COVID-19 wave, an increase of 506% compared with the year before., Conclusions: This surgical prioritisation framework can be tailored to specific centres and countries to support priority setting for delayed elective operations during and after the COVID-19 pandemic, both in and between surgical disciplines. In the long-term, the framework can contribute to the efficient distribution of OR time and will therefore add to the discussion on appropriate use of healthcare budgets. The online framework can be accessed via: https://stanwijn.shinyapps.io/priORitize/., Competing Interests: Competing interests: MMR had financial support by means of a VICI grant from NWO (Dutch Research Council) for the submitted work, the other authors had no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced 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.)

Objectives: To adjust for confounding in observational data, researchers use propensity score matching (PSM), but more advanced methods might be required when dealing with longitudinal data and time-varying treatments as PSM might not include possible changes that occurred over time. This study aims to explore which confounding adjustment methods have been used in longitudinal observational data to estimate a treatment effect and identify potential inappropriate use of PSM., Design: Mapping review., Data Sources: We searched PubMed, from inception up to January 2021, for studies in which a treatment was evaluated using longitudinal observational data., Eligibility Criteria: Methodological, non-medical and cost-effectiveness papers were excluded, as were non-English studies and studies that did not study a treatment effect., Data Extraction and Synthesis: Studies were categorised based on time of treatment: at baseline (interventions performed at start of follow-up) or time-varying (interventions received asynchronously during follow-up) and sorted based on publication year, time of treatment and confounding adjustment method. Cumulative time series plots were used to investigate the use of different methods over time. No risk-of-bias assessment was performed as it was not applicable., Results: In total, 764 studies were included that met the eligibility criteria. PSM (165/201, 82%) and inverse probability weighting (IPW; 154/502, 31%) were most common for studies with a treatment at baseline (n=201) and time-varying treatment (n=502), respectively. Of the 502 studies with a time-varying treatment, 123 (25%) used PSM with baseline covariates, which might be inappropriate. In the past 5 years, the proportion of studies with a time-varying treatment that used PSM over IPW increased., Conclusions: PSM is the most frequently used method to correct for confounding in longitudinal observational data. In studies with a time-varying treatment, PSM was potentially inappropriately used in 25% of studies. Confounding adjustment methods designed to deal with a time-varying treatment and time-varying confounding are available, but were only used in 45% of the studies with a time-varying treatment., 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: To determine the cost-effectiveness of auditory brainstem response prior to MRI (ABR-MRI) compared to standalone MRI to diagnose vestibular schwannoma., Design: A state transition model was developed to simulate costs and effects (quality-adjusted life years [QALY]) for both diagnostic strategies for patients suspected of a vestibular schwannoma. Model input was derived from literature, hospital databases and expert opinions. Scenario and sensitivity analyses addressed model uncertainty., Results: Over a lifetime horizon, ABR-MRI resulted in a limited cost-saving of €68 or €98 per patient (dependent on MRI sequence) and a health loss of 0.005 QALYs over standalone MRI. ABR-MRI, however, did miss patients with other important pathology (2% of the population) that would have been detected when using standalone MRI. In total, €14 203 or €19 550 could be saved per lost QALY if ABR-MRI was used instead of standalone MRI. The results were sensitive to the detection rate of vestibular schwannoma and health-related quality of life of missed patients., Conclusion: The cost-saving with ABR-MRI does not seem to outweigh the number of missed patients with VS and other important pathologies that would have been detected when using standalone MRI., (© 2021 The Authors. Clinical Otolaryngology published by John Wiley & Sons Ltd.)

Front-of-package food labeling (FoPFL) is increasingly advocated as an effective intervention to facilitate behavior changes toward healthier food purchasing and consumption, particularly in relation to products with added sugar. The present study assessed the potential caries-related impacts of FoPFL, using Germany as an example. The outcomes of interest were caries lesions prevented, dental treatment costs avoided, productivity loss reductions, and disability-adjusted life years (DALYs) averted. The baseline consumption of added sugar was derived from the German National Nutrition Survey. The reduction in sugar intake due to FoPFL was modeled according to estimates from a recent meta-analysis. Microsimulations were performed for 500,000 individuals and over a time horizon of 10 y. Deterministic and probabilistic sensitivity analyses were performed to check the robustness of results. For the period from 2017 to 2027, FoPFL was identified to prevent 2,370,715 (95% confidence interval [CI], 2,062,730-2,678,700) caries lesions and avert 677.62 (95% CI, 589.59-765.65) DALYs. Treatment cost savings amounted to €175.67 million (95% CI, €152.85-€198.49), and productivity losses reduced by €27.33 million (95% CI, €23.78-€30.88). Sensitivity analyses showed that the magnitude of the effects is highly dependent on consumers' response to FoPFL. Our findings suggest that FoPFL has the potential to substantially reduce caries increment, caries-related morbidity, and economic burden. In addition, our study allows for the inclusion of oral health estimates in overall health estimates for sugar-related food labeling. Before prioritizing a strategy to tackle sugar consumption, decision makers should carefully consider all relevant context-specific factors and implementation costs.

Objective: To assess the cost-effectiveness of sentinel lymph node mapping compared to risk factor assessment and routine full lymph node dissection for the assessment of lymph nodes in patients with low- and intermediate-risk endometrioid endometrial cancer., Methods: A decision-analytic model was designed to compare three lymph node assessment strategies in terms of costs and effects: 1) sentinel lymph node mapping; 2) post-operative risk factor assessment (adjuvant therapy based on clinical and histological risk factors); 3) full lymph node dissection. Input data were derived from systematic literature searches and expert opinion. QALYs were used as measure of effectiveness. The model was built from a healthcare perspective and the impact of uncertainty was assessed with sensitivity analyses., Results: Base-case analysis showed that sentinel lymph node mapping was the most effective strategy for lymph node assessment in patients with low- and intermediate-risk endometrial cancer. Compared to risk factor assessment it was more costly, but the incremental cost effectiveness ratio stayed below a willingness-to-pay threshold of €20,000 with a maximum of €9637/QALY. Sentinel lymph node mapping was dominant compared to lymph node dissection since it was more effective and less costly. Sensitivity analyses showed that the outcome of the model was robust to changes in input values. With a willingness-to-pay threshold of €20,000 sentinel lymph node mapping remained cost-effective in at least 74.3% of the iterations., Conclusion: Sentinel lymph node mapping is the most cost-effective strategy to guide the need for adjuvant therapy in patients with low and intermediate risk endometrioid endometrial cancer., Competing Interests: Declaration of Competing Interest The authors declare no potential conflicts of interest., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: Recent studies have suggested that corticosteroid injections into the knee may harm the joint resulting in cartilage loss and possibly accelerating the progression of osteoarthritis (OA). The aim of this study was to assess whether patients with, or at risk of developing, symptomatic osteoarthritis of the knee who receive intra-articular corticosteroid injections have an increased risk of requiring arthroplasty., Methods: We used data from the Osteoarthritis Initiative (OAI), a multicentre observational cohort study that followed 4,796 patients with, or at risk of developing, osteoarthritis of the knee on an annual basis with follow-up available up to nine years. Increased risk for symptomatic OA was defined as frequent knee symptoms (pain, aching, or stiffness) without radiological evidence of OA and two or more risk factors, while OA was defined by the presence of both femoral osteophytes and frequent symptoms in one or both knees. Missing data were imputed with multiple imputations using chained equations. Time-dependent propensity score matching was performed to match patients at the time of receving their first injection with controls. The effect of corticosteroid injections on the rate of subsequent (total and partial) knee arthroplasty was estimated using Cox proportional-hazards survival analyses., Results: After removing patients lost to follow-up, 3,822 patients remained in the study. A total of 249 (31.3%) of the 796 patients who received corticosteroid injections, and 152 (5.0%) of the 3,026 who did not, had knee arthroplasty. In the matched cohort, Cox proportional-hazards regression resulted in a hazard ratio of 1.57 (95% confidence interval (CI) 1.37 to 1.81; p < 0.001) and each injection increased the absolute risk of arthroplasty by 9.4% at nine years' follow-up compared with those who did not receive injections., Conclusion: Corticosteroid injections seem to be associated with an increased risk of knee arthroplasty in patients with, or at risk of developing, symptomatic OA of the knee. These findings suggest that a conservative approach regarding the treatment of these patients with corticosteroid injections should be recommended. Cite this article: Bone Joint J 2020;102-B(5):586-592.

Introduction: Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical treatment, the incidence of APM remains high. The common perception by most orthopaedic surgeons is that there are subgroups of patients that do need APM to improve, and they argue that each study sample of the existing trials is not representative for the day-to-day patients in the clinic. Therefore, the objective of this individual participant data meta-analysis (IPDMA) is to assess whether there are subgroups of patients with degenerative meniscus lesions who benefit from APM in comparison with non-surgical or sham treatment., Methods and Analysis: An existing systematic review will be updated to identify all RCTs worldwide that evaluated APM compared with sham treatment or non-surgical treatment in patients with knee symptoms and degenerative meniscus tears. Time and effort will be spent in contacting principal investigators of the original trials and encourage them to collaborate in this project by sharing their trial data. All individual participant data will be validated for missing data, internal data consistency, randomisation integrity and censoring patterns. After validation, all datasets will be combined and analysed using a one-staged and two-staged approach. The RCTs' characteristics will be used for the assessment of clinical homogeneity and generalisability of the findings. The most important outcome will be the difference between APM and control groups in knee pain, function and quality of life 2 years after the intervention. Other outcomes of interest will include the difference in adverse events and mental health., Ethics and Dissemination: All trial data will be anonymised before it is shared with the authors. The data will be encrypted and stored on a secure server located in the Netherlands. No major ethical concerns remain. This IPDMA will provide the evidence base to update and tailor diagnostic and treatment protocols as well as (international) guidelines for patients for whom orthopaedic surgeons consider APM. The results will be submitted for publication in a peer-reviewed journal., Prospero Registration Number: CRD42017067240., 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.)

Objectives: With the increasing interest in personalised medicine, the use of subgroup analyses is likely to increase. Subgroup analyses are challenging and often misused, possibly leading to false interpretations of the effect. It remains unclear to what extent key organisations warn for such pitfalls and translate current methodological research to detect these effects into research guidelines. The aim of this scoping review is to determine and evaluate the current guidance used by organisations for exploring, confirming and interpreting subgroup effects., Design: Scoping review., Eligibility Criteria: We identified four types of key stakeholder organisations: industry, health technology assessment organisations (HTA), academic/non-profit research organisations and regulatory bodies. After literature search and expert consultation, we identified international and national organisations of each type. For each organisation that was identified, we searched for official research guidance documents and contacted the organisation for additional guidance., Results: Twenty-seven (45%) of the 60 organisations that we included had relevant research guidance documents. We observed large differences between organisation types: 18% (n=2) of the industry organisations, 64% (n=9) of the HTA organisations, 38% (n=8) of academic/non-profit research organisations and 57% (n=8) of regulatory bodies provided guidance documents. The majority of the documents (n=33, 63%) mentioned one or more challenges in subgroup analyses, such as false positive findings or ecological bias with variations across the organisation types. Statistical recommendations were less common (n=19, 37%) and often limited to a formal test of interaction., Conclusions: Almost half of the organisations included in this scoping review provided guidance on subgroup effect research in their guidelines. However, there were large differences between organisations in the amount and level of detail of their guidance. Effort is required to translate and integrate research findings on subgroup analysis to practical guidelines for decision making and to reduce the differences between organisations and organisation types., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)