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Methodology over metrics: current scientific standards are a disservice to patients and society.

ABSTRACT: Covid-19 research made it painfully clear that the scandal of poor medical research, as denounced by Altman in 1994, persists today. The overall quality of medical research remains poor, despite longstanding criticisms. The problems are well known, but the research community fails to properly address them. We suggest that most problems stem from an underlying paradox: although methodology is undeniably the backbone of high-quality and responsible research, science consistently undervalues methodology. The focus remains more on the destination (research claims and metrics) than on the journey. Notwithstanding, research should serve society more than the reputation of those involved. While we notice that many initiatives are being established to improve components of the research cycle, these initiatives are too disjointed. The overall system is monolithic and slow to adapt. We assert that top-down action is needed from journals, universities, funders and governments to break the cycle and put methodology first. These actions should involve the widespread adoption of registered reports, balanced research funding between innovative, incremental and methodological research projects, full recognition and demystification of peer review, improved methodological review of reports, adherence to reporting guidelines, and investment in methodological education and research. Currently, the scientific enterprise is doing a major disservice to patients and society.

SUBMITTER: Van Calster B

PROVIDER: S-EPMC8795888 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveOur objective was to provide a scholarly review of the published literature on menopausal hormonal therapy (MHT), make scientifically valid assessments of the available data, and grade the level of evidence available for each clinically important endpoint. PARTICIPANTS IN DEVELOPMENT OF SCIENTIFIC STATEMENT: The 12-member Scientific Statement Task Force of The Endocrine Society selected the leader of the statement development group (R.J.S.) and suggested experts with expertise in specific areas. In conjunction with the Task Force, lead authors (n = 25) and peer reviewers (n = 14) for each specific topic were selected. All discussions regarding content and grading of evidence occurred via teleconference or electronic and written correspondence. No funding was provided to any expert or peer reviewer, and all participants volunteered their time to prepare this Scientific Statement.EvidenceEach expert conducted extensive literature searches of case control, cohort, and randomized controlled trials as well as meta-analyses, Cochrane reviews, and Position Statements from other professional societies in order to compile and evaluate available evidence. No unpublished data were used to draw conclusions from the evidence.Consensus processA consensus was reached after several iterations. Each topic was considered separately, and a consensus was achieved as to content to be included and conclusions reached between the primary author and the peer reviewer specific to that topic. In a separate iteration, the quality of evidence was judged using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system in common use by The Endocrine Society for preparing clinical guidelines. The final iteration involved responses to four levels of additional review: 1) general comments offered by each of the 25 authors; 2) comments of the individual Task Force members; 3) critiques by the reviewers of the Journal of Clinical Endocrinology & Metabolism; and 4) suggestions offered by the Council and members of The Endocrine Society. The lead author compiled each individual topic into a coherent document and finalized the content for the final Statement. The writing process was analogous to preparation of a multiauthored textbook with input from individual authors and the textbook editors.ConclusionsThe major conclusions related to the overall benefits and risks of MHT expressed as the number of women per 1000 taking MHT for 5 yr who would experience benefit or harm. Primary areas of benefit included relief of hot flashes and symptoms of urogenital atrophy and prevention of fractures and diabetes. Risks included venothrombotic episodes, stroke, and cholecystitis. In the subgroup of women starting MHT between ages 50 and 59 or less than 10 yr after onset of menopause, congruent trends suggested additional benefit including reduction of overall mortality and coronary artery disease. In this subgroup, estrogen plus some progestogens increased the risk of breast cancer, whereas estrogen alone did not. Beneficial effects on colorectal and endometrial cancer and harmful effects on ovarian cancer occurred but affected only a small number of women. Data from the various Women's Health Initiative studies, which involved women of average age 63, cannot be appropriately applied to calculate risks and benefits of MHT in women starting shortly after menopause. At the present time, assessments of benefit and risk in these younger women are based on lower levels of evidence.

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Methodology over metrics: current scientific standards are a disservice to patients and society.

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