Statistical Methods to Examine Racial and Ethnic Disparities in the Surgical Literature: A Review and Recommendations for Improvement.

OBJECTIVE: We characterized the quality of statistical methods for studies of racial and ethnic disparities in the surgical-relevant literature during 2021-2022. BACKGROUND: Hundreds of scientific papers are published each year describing racial and ethnic disparities in surgical access, quality, and outcomes. The content and design quality of this literature has never been systematically reviewed. METHODS: We searched for 2021-2022 studies focused on describing racial and/or ethnic disparities in surgical or perioperative access, process quality, or outcomes. Identified studies were characterized in terms of three methodological criteria: 1) adjustment for variables related to both race/ethnicity and outcomes, including social determinants of health (SDOH); 2) accounting for clustering of patients within hospitals or other subunits ("providers") and; 3) distinguishing within- and between-provider effects. RESULTS: We identified 224 papers describing racial and/or ethnic differences. Of the 38 single institution studies, 24 (63.2%) adjusted for at least one SDOH variable. Of the 186 multisite studies, 113 (60.8%) adjusted for at least one SDOH variable, and 43 (23.1%) accounted for clustering of patients within providers using appropriate statistical methods. Only 10 (5.4%) of multi-institution studies made efforts to examine how much of overall disparities were driven by within versus between provider effects. CONCLUSIONS: Most recently published papers on racial and ethnic disparities in the surgical literature do not meet these important statistical design criteria and therefore may risk inaccuracy in the estimation of group differences in surgical access, quality, and outcomes. The most potent leverage points for these improvements are changes to journal publication guidelines and policies.

Systematic Review of Health Economic Impact Evaluations of Risk Prediction Models: Stop Developing, Start Evaluating.

BACKGROUND: Although health economic evaluations (HEEs) are increasingly common for therapeutic interventions, they appear to be rare for the use of risk prediction models (PMs). OBJECTIVES: To evaluate the current state of HEEs of PMs by performing a comprehensive systematic review. METHODS: Four databases were searched for HEEs of PM-based strategies. Two reviewers independently selected eligible articles. A checklist was compiled to score items focusing on general characteristics of HEEs of PMs, model characteristics and quality of HEEs, evidence on PMs typically used in the HEEs, and the specific challenges in performing HEEs of PMs. RESULTS: After screening 791 abstracts, 171 full texts, and reference checking, 40 eligible HEEs evaluating 60 PMs were identified. In these HEEs, PM strategies were compared with current practice (n = 32; 80%), to other stratification methods for patient management (n = 19; 48%), to an extended PM (n = 9; 23%), or to alternative PMs (n = 5; 13%). The PMs guided decisions on treatment (n = 42; 70%), further testing (n = 18; 30%), or treatment prioritization (n = 4; 7%). For 36 (60%) PMs, only a single decision threshold was evaluated. Costs of risk prediction were ignored for 28 (46%) PMs. Uncertainty in outcomes was assessed using probabilistic sensitivity analyses in 22 (55%) HEEs. CONCLUSIONS: Despite the huge number of PMs in the medical literature, HEE of PMs remains rare. In addition, we observed great variety in their quality and methodology, which may complicate interpretation of HEE results and implementation of PMs in practice. Guidance on HEE of PMs could encourage and standardize their application and enhance methodological quality, thereby improving adequate use of PM strategies.

Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments.

Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures, a survey of current HTA practices and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms that current device regulatory processes across the globe are substantially less stringent than drugs. As a result, international HTA agencies report that they face a number of challenges when assessing MDs, including reliance on suboptimal data to make clinical and cost-effectiveness decisions. Whilst many HTA agencies have adapted their processes and procedures to handle MD technology submissions, in our comparison of HTA reports we found little evidence of the application of methodologies that take account of device-specific issues, such as incremental development. Overall, our research reinforces the need for better linkage between licencing and HTA and the development and application of innovative HTA methodologies with the objective of securing faster patient access for those technologies that can be shown to represent good value for money. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd.

Health technology assessment of medical devices: a survey of non-European union agencies.

OBJECTIVES: The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies. METHODS: HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1-agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2-semi-structured telephone interviews with key informants of a sub-sample of agencies. RESULTS: In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non-MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices. CONCLUSIONS: The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.