Nursing School, University of São Paulo (USP), São Paulo, Sao Paulo, Brazil.
São Paulo State University Julio de Mesquita Filho (Unesp) - Botucatu Medical School, undergraduate student of medicine, Botucatu, Sao Paulo, Brazil.
Int Wound J. 2021 Apr;18(2):147-157. doi: 10.1111/iwj.13506. Epub 2020 Nov 25.
Randomised controlled trials of therapeutic interventions for pressure injuries should include a clear description of outcomes to increase transparency and replicability and improve the construction of scientific evidence. The objective of this study was to assess the completeness of the descriptions of the outcomes of therapeutic interventions in adults with pressure injury (PI) and factors associated with completeness. This was a systematic methodological survey. The completeness of the outcome was assessed according to five criteria: domain (title), specific measure (technique/instrument used), specific metric, or format of the outcome data of each participant that was used for analysis, aggregation (method data from each group were summarised), and time that was used for analysis. Sixty-eight studies were included for analysis. A total of 265 outcomes were reported, and 46 trials (67.6%) had 73 primary outcomes, which were mainly intermediates/substitutes (78.8%). The main outcome evaluated was the ulcer area reduction (36.6%). Approximately 37.2% of the outcomes were incompletely reported, and the least described element was the data aggregation method (72.8%). Only 48.4% of the outcomes with the specified technique had the same reference or validation. Poor quality of reporting outcomes was associated with studies with an older year of publication and a small sample size, single-center studies, and those sponsored by industry. PI studies use many outcomes, mostly surrogates or intermediates, and some of them are incompletely described.
随机对照试验的治疗干预措施的压力损伤应包括一个明确的描述结果，以提高透明度和可重复性，并改善科学证据的构建。本研究的目的是评估成人压力性损伤（PI）治疗干预结果描述的完整性，以及与完整性相关的因素。这是一项系统的方法学调查。根据五个标准评估结果的完整性：领域（标题）、具体措施（使用的技术/仪器）、具体指标或每个参与者用于分析的结果数据格式、汇总（每组的数据汇总方法）和用于分析的时间。共纳入 68 项研究进行分析。共报告了 265 个结果，46 项试验（67.6%）有 73 个主要结果，主要是中间/替代结果（78.8%）。主要评估结果是溃疡面积减少（36.6%）。约有 37.2%的结果未完整报告，描述最少的元素是数据汇总方法（72.8%）。只有 48.4%指定技术的结果具有相同的参考或验证。结局报告质量较差与发表年代较早、样本量较小、单中心研究以及由工业界赞助的研究有关。PI 研究使用许多结果，主要是替代物或中间物，其中一些结果描述不完整。
