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The case for formal methodology in scientific reform.

ABSTRACT: Current attempts at methodological reform in sciences come in response to an overall lack of rigor in methodological and scientific practices in experimental sciences. However, most methodological reform attempts suffer from similar mistakes and over-generalizations to the ones they aim to address. We argue that this can be attributed in part to lack of formalism and first principles. Considering the costs of allowing false claims to become canonized, we argue for formal statistical rigor and scientific nuance in methodological reform. To attain this rigor and nuance, we propose a five-step formal approach for solving methodological problems. To illustrate the use and benefits of such formalism, we present a formal statistical analysis of three popular claims in the metascientific literature: (i) that reproducibility is the cornerstone of science; (ii) that data must not be used twice in any analysis; and (iii) that exploratory projects imply poor statistical practice. We show how our formal approach can inform and shape debates about such methodological claims.

SUBMITTER: Devezer B

PROVIDER: S-EPMC8101540 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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The case for formal methodology in scientific reform.

Devezer Berna B Navarro Danielle J DJ Vandekerckhove Joachim J Ozge Buzbas Erkan E

Royal Society open science 20210331 3

Current attempts at methodological reform in sciences come in response to an overall lack of rigor in methodological and scientific practices in experimental sciences. However, most methodological reform attempts suffer from similar mistakes and over-generalizations to the ones they aim to address. We argue that this can be attributed in part to lack of formalism and first principles. Considering the costs of allowing false claims to become canonized, we argue for formal statistical rigor and sc ...[more]

PMID: 34035933

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Project description:BackgroundErenumab has demonstrated effectiveness for prevention of migraine attacks, but the treatment is costly, and a considerable proportion of patients do not respond to it. The Registry for Migraine study (REFORM) was initiated to discover biomarkers that can predict response to erenumab in patients with migraine. The specific objective was to investigate differences in erenumab efficacy based on clinical information, blood-based biomarkers, structural and functional magnetic resonance imaging (MRI), and response to intravenous infusion of calcitonin gene-related peptide (CGRP). In this first report of the REFORM study, we provide a comprehensive description of the study methodology, and present the baseline characteristics of the study population.MethodsThe REFORM study was a single-center, prospective, longitudinal cohort study in adults with migraine who were scheduled to receive preventive treatment with erenumab as part of a separate, open-label, single-arm phase IV trial. The study included four periods: a 2-week screening period (Weeks -6 to -5), 4-week baseline period (Week -4 to Day 1), 24-week treatment period (Day 1 to Week 24), and a 24-week follow-up period without treatment (Week 25 to Week 48). Demographic and clinical characteristics were recorded using a semi-structured interview, whilst outcome data were obtained using a headache diary, patient-reported outcomes, blood sampling, brain MRI, and responsiveness to intravenous infusion of CGRP.ResultsThe study enrolled 751 participants, with a mean age ± SD of 43.8 ± 12.2 years, of which 88.8% (n = 667) were female. At enrollment, 64.7% (n = 486) were diagnosed with chronic migraine, and 30.2% (n = 227) had history of aura. The mean monthly migraine days (MMDs) was 14.5 ± 7.0. Concomitant preventive medications were used by 48.5% (n = 364) of the participants, and 39.9% (n = 300) had failed ≥ 4 preventive medications.ConclusionThe REFORM study enrolled a population with a high migraine burden and frequent use of concomitant medications. The baseline characteristics were representative of patients with migraine in specialized headache clinics. Future publications will report the results of the investigations presented in this article.Trial registrationThe study and sub-studies were registered on ClinicalTrials.gov (NCT04592952; NCT04603976; and NCT04674020).

Project description:BackgroundIt is unclear how formal long-term care (LTC) availability affects formal /informal caregiving patterns and caregiver health. We tested the impact of reduced formal LTC availability on formal LTC service use, intensity of informal caregiving, and caregiver health.MethodsUsing a representative, repeated cross-sectional sample of Japanese caregivers providing care to co-resident family members from 2001 to 2016, we applied a difference-in-differences approach by observing caregivers before and after the major reform of the public Japanese LTC insurance (LTCI) in 2006. The reform reduced coverage benefits for non-institutionalized older persons with low care needs, but not for those with high care needs. We analyzed 12,764 caregivers aged ≥30 years (mean age 64.3 ± 11.8 years, 73.5% women) and measured indicators of formal LTC use, hours of informal caregiving, and caregiver self-reported health outcomes after propensity score matching to balance caregivers' background characteristics.ResultsWe found the 2006 LTCI reform relatively reduced the use of formal LTC services and relatively increased the percentage of experiencing long hours of informal caregiving (> 3 h per day) among the caregivers for seniors with low care needs compared to those for seniors with high care needs. The effects of the LTCI reform for the caregivers for seniors with low care needs were 2.2 percentage point higher on caregivers' experiencing poor self-rated health (95% confidence interval [CI]: 0.7-3.7; p = 0.01), 2.7 percentage point higher on experiencing symptoms of a depressive state (95%CI: 0.5-4.8; p = 0.03), and 4.7 percentage point higher on experiencing symptoms of musculoskeletal diseases (95%CI, 3.6-5.7; p < 0.001), compared to those for seniors with high care needs.ConclusionsReduced formal care availability under the Japanese LTCI reform increased hours of informal caregiving corresponding to reduced use of formal LTC and deteriorated multiple dimensions of caregiver health. Our findings may highlight the importance of enhancing the availability of formal LTC services for caregiver health.

Project description:Background: Exponential increases in the development of medical knowledge, the expansion of areas where medicine develops its activities, the emergence of new pathologies ( e.g., COVID-19), novel diagnostic methods and therapeutic strategies, together with the appearance of multiple communication and information technologies, determined that the education of future physicians required targeted training in scientific methodology. Methods: The design and execution of a course in scientific methodology in the curriculum of Facultad de Medicina, Universidad de la República, Uruguay, is described. The course is carried out at an advanced stage of the medical studies for all the students, in which they develop a 10-month research project supervised by the medical school faculty. Students undergo all stages of a research endeavor: generation of hypothesis, elaboration of a research protocol, submission to the Research Ethics and Animal Welfare Committees, data recollection, analysis, interpretation and publication of the results. Results: The course is undertaken at the Facultad de Medicina, Universidad de la República, Uruguay, the main university of the country, with high numbers of students enrolled. The course involves the participation of 600 students and up to 300 professors per year, which implies a huge institutional effort Conclusions: The scientific methodology course resulted in one of the most important incorporations of the current 2008 curriculum. Local students, faculty and international evaluators have qualified this activity as an educational breakthrough, being a gratifying and productive experience. The course represented the first exposure of medical students to the research methodology, scientific literature and publication rules, and emphasized the dynamic nature of medical knowledge within modern medical education. Moreover, for some students it constituted the onset of academic research careers. An additional positive outcome was the reactivation of some faculty research projects, in a way that largely exceeded the boundaries of the course.

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The case for formal methodology in scientific reform.

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The case for formal methodology in scientific reform.

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