Tripathi Raakhi, Khatri Nishtha, Mamde Ambika
Associate Professor.
Postgraduate Student, Seth G.S. Medical College and K.E.M. Hospital, Mumbai, Maharashtra; Corresponding Author.
J Assoc Physicians India. 2020 Mar;68(3):14-18.
: Appropriate calculation of sample size and choosing the correct sampling technique are of paramount importance to produce studies that are capable of drawing clinically relevant conclusions with generalizability of results. The current study was planned with an objective to determine reporting of sample size and sampling considerations in clinical research articles published in the year 2017.
One high impact factor journal and one low impact factor journal belonging to the specialities of Medicine, Surgery, Obstetrics and Gynaecology, Paediatrics and Pharmacology were selected and checked for adherence to reporting of sample size and sampling considerations.
A total of 264 articles were examined. These consisted of 55 interventional studies and 209 observational studies. Interventional studies showed higher reporting of sample size calculation/justification for sample size selection (29.1%) compared to observational studies (14.8%). Only 33 out of 155 articles from high impact factor journals and 14 out of 109 articles from low impact factor journals mentioned about sample size calculation or justified the sample size. In addition to this, merely 68 out of 209 observational studies mentioned about sampling considerations such as sampling technique/participant follow up/matching details.
The reporting of sample size and sampling considerations was found to be low in both high impact factor and low impact factor journals. Though interventional studies had better reporting compared to other study designs, the reporting was still not adequate and there is an immense scope for improvement.
恰当计算样本量并选择正确的抽样技术对于开展能够得出具有临床相关性结论且结果具有可推广性的研究至关重要。本研究旨在确定2017年发表的临床研究文章中样本量的报告情况及抽样考量因素。
选取一本高影响因子期刊和一本低影响因子期刊，期刊所属专业包括医学、外科、妇产科、儿科和药理学，检查其对样本量报告及抽样考量因素的遵循情况。
共审查了264篇文章。其中包括55项干预性研究和209项观察性研究。与观察性研究（14.8%）相比，干预性研究在样本量计算/样本量选择理由的报告方面比例更高（29.1%）。在高影响因子期刊的155篇文章中，只有33篇提及样本量计算或对样本量进行了说明；在低影响因子期刊的109篇文章中，只有14篇提及。除此之外，在209项观察性研究中，仅有68篇提到了抽样考量因素，如抽样技术/参与者随访/匹配细节。
发现高影响因子期刊和低影响因子期刊在样本量及抽样考量因素的报告方面都较少。尽管干预性研究的报告情况比其他研究设计要好，但报告仍不充分，有很大的改进空间。
