Misconceptions about randomisation harm validity of randomised controlled trials.

Rationale: The coherence theory of truth, the epistemology of evidence‐based medicine, mathematical statistics, and axiomatic mathematics. Aims and Objectives: To explore mathematical misconceptions inhering in randomised controlled trial designs, suggest improvements, encourage meta‐methodological...

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Publicado en:Journal of Evaluation in Clinical Practice Vol. 31; no. 5; pp. 1 - 4
Autor principal: Mastnak, Wolfgang
Formato: Journal Article
Publicado: Wiley-Blackwell Aug2025
Acceso en línea:Ver este registro en EBSCOhost
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      issn: 13561294
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      dt: Aug2025
      vid: 31
      iid: 5
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        10.1111/jep.14224
        187574742
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      tig:
        atl: Misconceptions about randomisation harm validity of randomised controlled trials.
      aug:
        au: Mastnak, Wolfgang
        affil: School of Arts and Communication 北京师范大学艺术与传媒学院, Beijing Normal University, 19 Xinwai Ave, Beitaipingzhuang, Beijing Haidian District, , China
      sug:
        subj:
          Randomized Controlled Trials
          Random Assignment
          Study Design
          Mathematics
          Credibility (Research)
          Sampling Bias
          Statistical Significance
          Random Sample
          Sampling Error
          Research Methodology
          Internal Validity
          Research, Interdisciplinary
          Medical Practice, Evidence-Based
          Research Personnel
          Professional Knowledge
          Simulations
      ab: Rationale: The coherence theory of truth, the epistemology of evidence‐based medicine, mathematical statistics, and axiomatic mathematics. Aims and Objectives: To explore mathematical misconceptions inhering in randomised controlled trial designs, suggest improvements, encourage meta‐methodological discussions and call for further interdisciplinary studies. Method: Mathematical‐statistical analyses and science‐philosophical considerations. Results: Randomisation does not (necessarily) generate equal samples, ergo, outcomes of usual RCTs are not as reliable as they claim. Moreover, ignoring initial sample discrepancies may cause inaccuracies similar to type I and type II errors. Insufficient awareness of these flaws harms final RCT statements about significance and evidence levels, hence their loss of trustworthiness. Statistical parameters such as the standard error of the mean may help to estimate the expected distinction between random samples. Conclusion: Researchers in EBM should be aware of systemic misconceptions in RCT standards. Pre‐measurement can reduce shortcomings, e.g. through calculation how sample differences impact on usual RCT processing, or randomisation is given up in favour of mathematical minimisation of sample differences, i.e. optimising statistical sample equality. Moreover, the promising future of dynamic simulation models is highlighted.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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