Retrospective chart review (RCR) is a type of research that answers specific research questions based on the existing patient medical records or related databases through a series of research processes including data extraction, data collation, statistical analysis, etc. Relying on the development of medical big data, as well as the relatively simple implementation process and low cost of information acquisition, RCR is increasingly used in the medical research field. In this paper, we conducted the visual analysis of high-quality RCR published in the past five years, and explored and summarized the current research status and hotspots by analyzing the characteristics of the number of publications, national/regional and institutional cooperation networks, author cooperation networks, keyword co-occurrence and clustering networks. We further systematically combed the methodological core of this kind of research from eight aspects: research question and hypothesis, applicability of chart, study design, data collecting, statistical analysis, interpretation of results, and reporting specification. By summarizing the shortcomings, unique advantages and application prospects of RCR, providing guidance and suggestions for the standardized application of RCR in the medical research field in the future.
Objective To systematically review published methodological guidelines for health technology assessment (HTA) at home and abroad. Methods Common electronic databases, guideline databases, international networks of HTA agencies/organizations, representative national HTA networks and official websites of governmental health departments were extensively searched and screened to identify guidelines for conducting or reporting HTA from inception to April 24, 2023. Basic information on guidelines, HTA processes, assessment indicators, reporting checklists and other information was extracted, analyzed and described using a systematic review methodology. Results A total of 41 guidelines were included in this study, published from January 2002 to January 2023; the publishing institutions involved 23 countries/international organizations, and 6 languages; the assessments were mainly for all health technologies (n=23), pharmaceuticals (n=4), diagnostic/testing technologies (n=4), non-pharmaceutical health technologies (n=3), medical devices/equipment (n=3), hospital health technologies (n=2), medical and surgical interventions (n=1), and screening technologies (n=1); the assessment perspectives were mainly health system perspectives (n=16), societal perspectives (n=12), and hospital perspectives (n=3), while the rest did not provide information on the perspectives; 28 guidelines described the detailed HTA assessment process, involving 11 steps; there were 39 guidelines described the assessment domains and related assessment indicators in detail, ranging from 2 to 9 assessment domains and involving 10 first-level assessment indicators; a checklist for HTA reports listed in 10 guidelines, involving 18 report entries; 17 guidelines reported conflicts of interest, mostly no conflicts of interest (n=10), and 3 of the remaining 7 guidelines did not indicate a specific conflict of interest, while 4 guidelines in which possible sources of conflict of interest were indicated. Conclusion The development of HTA has formed a relatively perfect assessment system, but there is a need to unify the criteria for classification of health technologies and reporting checklist, improve the specificity indicators for different types of health technologies, and clarify the assessment perspectives. Combined with the current situation of HTA development in China, contextualized guidelines for HTA implementation and reporting should be formulated to provide scientific information and methodological basis for decision-making on rational allocation of health resources.
With the increasingly prominent contradiction between limited health resources and the growing population, priority setting of health research, as a response, has received widespread attention from health systems worldwide. As the results of priority setting at different levels increase year by year, some questions in the results reporting are also constantly emerging. For example, the process of producing the results is vague, too dependent on individual subjective judgment, the participation of individual stakeholder groups is limited or lack of voice, unable to identify potential conflicts of interest, and so on. It does not only seriously affect the effectiveness and rationality of the results themselves, but also create intangible obstacles to their promotion and adoption. In 2019, BMC Medical Research Methodology published ‘Reporting guideline for priority setting of health research (REPRISE)’, which makes uniform specifications for more comprehensive and consistent reporting of results in priority areas. This paper interpreted the background, formulation process and key contents of the REPRISE guideline, with an aim to promote the application of the reporting guideline in China.
As a tool for building consensus among groups, Delphi technique has been widely used in healthcare research which is appropriate for clinical questions where quantitative methods are unlikely to yield results that can be successfully implemented in practice. Researchers in palliative care developed standards for conducting and reporting Delphi studies (CREDES). This paper introduces and interprets the specific content of CREDES standards, with a view to providing reference for the evaluation of Delphi research design quality and report transparency.
ObjectiveTo systematically review the studies on the clinical comprehensive evaluation system of drugs at home and abroad. MethodsThe PubMed, EMbase, Cochrane Library, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect the literature and policy documents of the clinical comprehensive evaluation system of drugs from inception to October 31, 2022. The evaluation organization, evaluation perspective, application scope, domains and criteria were sorted out, and the evaluation of different types of drugs was analyzed in detail. ResultsA total of 101 clinical comprehensive evaluation systems of drugs were included. The publishing time was from 2009 to 2022, and the number of published articles increased. The first author mainly came from 26 countries, including China (n=34), Canada (n=11), the United States (n=10), and Spain (n=10). Forty-seven articles reported the evaluation perspective. All evaluation systems could be used for drug evaluation, of which 43 could be used as universal evaluation tools, and 58 could be used for the evaluation of specific drugs, mainly including anti-tumor drugs (n=15), orphan drugs (n=10) and traditional Chinese medicine (n=7). The number of evaluation domains varied from 2 to 22, and the number of criteria varied from 4 to 56. Among them, economics (n=73), effectiveness (n=72), safety (n=54), disease demand/burden (n=34), and innovation (n=24) were the most frequent evaluation domains. ConclusionThe research on clinical comprehensive evaluation of drugs at home and abroad has grown up. During the implementation of clinical comprehensive evaluation of Chinese patent medicine, it is necessary to clarify the evaluation perspective, define the evaluation scope, and determine the evaluation domains.
Health Technology Assessment International (HTAi), in conjunction with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), initiated a joint Task Force and published guideline and a checklist for deliberative processes for health technology assessment (HTA). Currently, there is a lack of guidance for designing and implementing deliberative processes of HTA in China, so this paper performs a detailed interpretation of the guideline and checklist, with a view to providing a reference for China's HTA and deliberative process, in order to promote the dissemination and application of the HTA methodology, and advance the construction of domestic HTA deliberative processes capacity and institutional mechanism.
Objective To systematically review the methodological quality of research on clinical prediction models of traditional Chinese medicine. Methods The PubMed, Embase, Web of Science, CNKI, WanFang Data, VIP and SinoMed databases were electronically searched to collect literature related to the research on clinical prediction models of traditional Chinese medicine from inception to March 31, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies based on prediction model risk of bias assessment tool (PROBAST). Results A total of 113 studies on clinical prediction models of traditional Chinese medicine (79 diagnostic model studies and 34 prognostic model studies) were included. Among them, 111 (98.2%) studies were rated at high risk of bias, while 1 (0.9%) study was rated at low risk of bias and risk of bias of 1 (0.9%) study was unclear. The analysis domain was rated with the highest proportion of high risk of bias, followed by the participants domain. Due to the widespread lack of reporting of specific study information, risk of bias of a large number of studies was unclear in both predictors and outcome domain. Conclusion Most existing researches on clinical prediction models of traditional Chinese medicine show poor methodological quality and are at high risk of bias. Factors contributing to risk of bias include non-prospective data source, outcome definitions that include predictors, inadequate modeling sample size, inappropriate feature selection, inaccurate performance evaluation, and incorrect internal validation methods. Comprehensive methodological improvements on design, conduct, evaluation, and validation of modeling, as well as reporting of all key information of the models are urgently needed for future modeling studies, aiming to facilitate their translational application in medical practice.