Tseng Timothy Y, Breau Rodney H, Fesperman Susan F, Vieweg Johannes, Dahm Philipp
Division of Urologic Surgery, Duke University Medical Center, Durham, NC, USA.
BJU Int. 2009 Apr;103(8):1026-31. doi: 10.1111/j.1464-410X.2008.08155.x. Epub 2008 Nov 19.
To develop and apply a standardized evaluation form for assessing the methodological and reporting quality of observational studies of surgical interventions in urology.
An evaluation standard was developed using the Consolidated Standards for Reporting Trials statement and previously reported surgical reporting quality instruments. Consensus scoring among three reviewers was developed using two distinct sets of studies. All comparative observational trials involving therapeutic surgical procedures published in four major urological journals in 1995 and 2005 were randomly assigned to each reviewer. Categories of reporting adequacy included background, intervention, statistical analysis, results and discussion.
Twenty-seven articles in 1995 and 62 in 2005 met the inclusion criteria; 90% of studies were retrospective. From 1995 to 2005, the overall reporting quality score increased by 3.9 points (95% confidence interval, CI, 2.7-5.9; P = 0.001), from a mean (SD) of 19.1 (3.9) to 23.0 (4.2) on a scale of 0-42. There were significant improvements in the reporting categories of study background (+0.7 points, 95% CI 0.1-1.3, P = 0.043, 0-8-point scale), intervention (+1.6 points, 0.8-2.3, P = 0.001, 0-9-point scale), and statistical analysis (+0.8 points, 0.2-1.4, P = 0.006, 0-9-point scale). There were smaller and statistically insignificant improvements for results (+0.5 points, -0.3 to 1.2, P = 0.217, 0-10-point scale) and discussion reporting (+0.4 points, -0.1 to 0.8, P = 0.106, 0-6-point scale).
There have been minor improvements in the reporting of observational studies of surgical intervention between 1995 and 2005. However, reporting quality remains suboptimal. Clinical investigators, reviewers and journal editors should continue to strive for transparent reporting of the observational studies representing the bulk of the clinical evidence for urological procedures.
制定并应用标准化评估表，以评估泌尿外科手术干预观察性研究的方法学质量和报告质量。
依据《报告试验的统一标准》声明及先前报道的手术报告质量评估工具制定评估标准。使用两组不同的研究让三位评审员达成共识评分。1995年和2005年在四种主要泌尿外科期刊上发表的所有涉及治疗性外科手术的比较性观察性试验被随机分配给每位评审员。报告充分性的类别包括背景、干预措施、统计分析、结果和讨论。
1995年有27篇文章，2005年有62篇文章符合纳入标准；90%的研究为回顾性研究。从1995年到2005年，总体报告质量得分提高了3.9分（95%置信区间，CI，2.7 - 5.9；P = 0.001），在0至42分的评分标准下，平均（标准差）得分从19.1（3.9）提高到23.0（4.2）。在研究背景（+0.7分，95%CI 0.1 - 1.3，P = 0.043，0至8分评分标准）、干预措施（+1.6分，0.8 - 2.3，P = 0.001，0至9分评分标准）和统计分析（+0.8分，0.2 - 1.4，P = 0.006，0至9分评分标准）的报告类别方面有显著改善。结果（+0.5分，-0.3至1.2，P = 0.217，0至10分评分标准）和讨论报告（+0.4分，-0.1至0.8，P = 0.106，0至6分评分标准）的改善较小且无统计学意义。
1995年至2005年间，手术干预观察性研究的报告有轻微改善。然而，报告质量仍未达到最佳。临床研究人员、评审员和期刊编辑应继续努力，以透明的方式报告代表泌尿外科手术大部分临床证据的观察性研究。
