Dauphinee Lindsay, Peipert Jeffrey F, Phipps Maureen, Weitzen Sherry
Division of Research and the George Anderson Outcomes Measurement Unit, Department of Obstetrics and Gynecology, Women & Infants Hospital, Brown Medical School, Providence, Rhode Island 02905, USA.
Obstet Gynecol. 2005 Oct;106(4):808-12. doi: 10.1097/01.AOG.0000175841.02155.c7.
To quantify trends over time in the research methodology and statistical reporting of published articles in the journal Obstetrics & Gynecology between the years 1991 and 2001.
We reviewed 226 articles reporting original clinical research in Obstetrics & Gynecology, including 75 consecutive articles from 1991 and 1996 and 76 consecutive studies from 2001. Articles were classified by research methodology and level of evidence: I for randomized trials; II for controlled trials and observational, analytic studies; and III for case reports or case series. We also noted whether the investigators reported a research hypothesis, P values, effect sizes, 95% confidence intervals, and sample size/power calculations. We calculated chi2 for linear trend to evaluate changes over this 10-year period.
Seventy-four percent of the 226 studies evaluated were level II. The percentage of randomized trials did not increase from 1991 to 2001. However, level II studies increased from 71% in 1991 to 88% in 2001 (P = .01). During the same period, level III studies (case reports and case series) declined from 19% in 1991 to 1% in 2001 (P < .001). We also noted that a clearly stated research hypothesis, effect measures (and respective confidence intervals), and sample size calculations were more common in more recent years.
In the journal Obstetrics & Gynecology, we noted that observational, analytic studies increased in frequency, anecdotal reports decreased, and statistical reporting has improved. However, there still exists considerable opportunities for improvement.
量化1991年至2001年间发表在《妇产科学》杂志上的文章的研究方法和统计报告随时间的趋势。
我们回顾了226篇报告妇产科学原始临床研究的文章,包括1991年和1996年的75篇连续文章以及2001年的76篇连续研究。文章根据研究方法和证据水平进行分类:I级为随机试验;II级为对照试验和观察性、分析性研究;III级为病例报告或病例系列。我们还记录了研究人员是否报告了研究假设、P值、效应量、95%置信区间以及样本量/效能计算。我们计算了线性趋势的卡方值以评估这10年期间的变化。
226项评估研究中有74%为II级。1991年至2001年,随机试验的比例没有增加。然而,II级研究从1991年的71%增加到2001年的88%(P = 0.01)。在同一时期,III级研究(病例报告和病例系列)从1991年的19%下降到2001年的1%(P < 0.001)。我们还注意到,近年来明确陈述的研究假设、效应测量(及相应的置信区间)和样本量计算更为常见。
在《妇产科学》杂志中,我们注意到观察性、分析性研究的频率增加,轶事报告减少,统计报告有所改善。然而,仍有相当大的改进空间。