研究特征影响了护理学随机对照试验的实用性：一项荟萃流行病学研究。

Study characteristics impacted the pragmatism of randomized controlled trial published in nursing: a meta-epidemiological study.

机构信息

Pharmacology and Drug Evaluation in Children and Pregnant Women EA7323, Paris Descartes University, Sorbonne Paris Cité, Paris, France; Clinical Research Unit Paris Descartes - CIC P1419, Necker Hospital, AP-HP, Paris, 75015 France.

出版信息

J Clin Epidemiol. 2019 Dec;116:18-25. doi: 10.1016/j.jclinepi.2019.07.017. Epub 2019 Jul 30.

DOI:10.1016/j.jclinepi.2019.07.017

PMID:31374332

Abstract

OBJECTIVES

The objective of this study was to examine the impact of study characteristics on the score of the pragmatism/explanatory continuum of randomized controlled trials (RCTs) published in nursing journals using the PRagmatic Explanatory Continuum Indicator Summary (PRECIS)-2 tool.

STUDY DESIGN AND SETTING

RCTs concerning five themes of nursing care indexed in the PubMed and CINAHL databases published from 2002 to 2005 and 2012 to 2015 were selected by title/abstract. A sample of 400 was randomly selected and evaluated with the PRECIS-2 tool and reading grid.

RESULTS

The median PRECIS score was 32 of a possible 45 [28; 36] corresponding to a medium level of pragmatism. Studies with "medication" as an intervention had a more explanatory PRECIS score than studies with other intervention types (P = 0.015). Studies with "placebo" and "no usual care" as comparators had a more explanatory PRECIS score (P = 0.0027). The pragmatism/explanatory level was unaffected by impact factor (P = 0.42), h-index of the first and last author (P = 0.27 and P = 0.25, respectively), funding (P = 0.32), blinding (P = 0.41), sample size (P = 0.22), and time (P = 0.11).

CONCLUSION

This study highlights the pragmatism/explanatory level of nursing RCTs, the impact of the field of the article, and the comparator type on the pragmatism of these studies. Further studies are needed to confirm the astonishing result that blinding resulted in no significant difference in the PRECIS score.

摘要

目的

本研究旨在使用 PRagmatic Explanatory Continuum Indicator Summary（PRECIS）-2 工具，考察研究特征对发表在护理期刊上的随机对照试验（RCT）实用主义/解释连续体评分的影响。

研究设计和设置

通过标题/摘要选择了 2002 年至 2005 年和 2012 年至 2015 年期间在 PubMed 和 CINAHL 数据库中索引的五个护理主题的 RCT。随机抽取 400 个样本，使用 PRECIS-2 工具和阅读网格进行评估。

结果

PRECIS 评分中位数为 32（45 的可能值为 32；28 至 36），对应于中等实用主义水平。干预措施为“药物”的研究比其他干预类型的研究具有更具解释性的 PRECIS 评分（P=0.015）。以“安慰剂”和“无常规护理”作为对照的研究具有更具解释性的 PRECIS 评分（P=0.0027）。实用主义/解释水平不受影响因素（P=0.42）、第一作者和最后作者的 h 指数（P=0.27 和 P=0.25）、资金（P=0.32）、盲法（P=0.41）、样本量（P=0.22）和时间（P=0.11）的影响。