关于随机化的误解损害了随机对照试验的有效性。

IF 2.1 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Journal of evaluation in clinical practice Pub Date : 2024-10-24 DOI:10.1111/jep.14224
Wolfgang Mastnak
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引用次数: 0

摘要

理论依据:真理一致性理论、循证医学认识论、数理统计和公理数学:探讨随机对照试验设计中固有的数学误区,提出改进建议,鼓励元方法论讨论,呼吁进一步开展跨学科研究:方法:数学统计分析和科学哲学思考:随机化并不能(必然)产生平等的样本,因此,通常的 RCT 结果并不像它们声称的那样可靠。此外,忽略初始样本差异可能会导致类似于 I 型和 II 型错误的不准确性。如果对这些缺陷认识不足,就会损害 RCT 关于显著性和证据水平的最终声明,从而使其失去可信度。平均值标准误差等统计参数可能有助于估计随机样本之间的预期差异:EBM研究人员应意识到RCT标准中的系统性误区。预先测量可以减少缺陷,例如通过计算样本差异对 RCT 常规处理的影响,或者放弃随机化,而采用数学方法最小化样本差异,即优化统计样本平等。此外,还强调了动态模拟模型的美好前景。
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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 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.

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来源期刊
CiteScore
4.80
自引率
4.20%
发文量
143
审稿时长
3-8 weeks
期刊介绍: The Journal of Evaluation in Clinical Practice aims to promote the evaluation and development of clinical practice across medicine, nursing and the allied health professions. All aspects of health services research and public health policy analysis and debate are of interest to the Journal whether studied from a population-based or individual patient-centred perspective. Of particular interest to the Journal are submissions on all aspects of clinical effectiveness and efficiency including evidence-based medicine, clinical practice guidelines, clinical decision making, clinical services organisation, implementation and delivery, health economic evaluation, health process and outcome measurement and new or improved methods (conceptual and statistical) for systematic inquiry into clinical practice. Papers may take a classical quantitative or qualitative approach to investigation (or may utilise both techniques) or may take the form of learned essays, structured/systematic reviews and critiques.
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