Hilton Paul, Buckley Brian S, McColl Elaine, Howel Denise, Tincello Douglas G, Brennand Catherine
Faculty of Medical Sciences, Medical School, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.
Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, UK.
Trials. 2016 Oct 26;17(1):522. doi: 10.1186/s13063-016-1652-2.
The INVESTIGATE-I study was designed to inform a future definitive randomised trial of invasive urodynamic testing, compared to basic clinical assessment with noninvasive tests prior to surgical treatment, in women with stress urinary incontinence or stress-predominant mixed urinary incontinence. In a pilot randomised controlled trial, women from seven participating sites were screened, consented and randomised. Overall, 771 patients were identified from clinic notes and correspondence as being potential recruits and were sent the Patient Information Leaflet. Of those screened, 284 were deemed eligible, giving an overall 'screen positive' rate of 37 %. The numbers screened at individual centres varied between 14 and 399; the 'screen positive' rate varied between 22 and 79 % and the percentage of eligible women recruited varied between 55 and 100 %. The aim of this additional substudy was to explore why 'screen positive' rates may have varied so widely between apparently similar sites.
All 11 trial staff involved in screening in the seven recruiting sites were asked to evaluate a series of 20 identical vignettes, mainly based on actual general practitioner referral letters. Of the vignettes, 16 mentioned one or more definite inclusion criteria; the remainder had possible inclusions. Four had definite exclusions; 12 had possible exclusions. Free-text comments were sought to clarify the screeners' decisions. For six vignettes everyone agreed that the patient was eligible; for one all agreed she was not eligible; the breakdown for the remainder was mixed. Free-text comments illuminated uncertainties that may have led to variability in judging potential eligibility.
Variability in judgements about potential trial eligibility highlights the importance of explicit and objective inclusion and exclusion criteria, and of agreed strategies for making judgements when information is missing. During the development and planning of trials, vignettes might be a valuable tool for training those involved in screening and recruiting patients, for identifying potential problems and ensuring greater consistency in the application of eligibility criteria.
ISTCTN registry: ISRCTN71327395 , registered on 7 June 2010.
“INVESTIGATE - I研究”旨在为未来一项关于压力性尿失禁或以压力性为主的混合性尿失禁女性患者的侵入性尿动力学检测的确定性随机试验提供信息，该试验将与手术治疗前采用非侵入性检测的基本临床评估进行对比。在一项先导性随机对照试验中，对来自七个参与地点的女性进行了筛查、征得同意并随机分组。总体而言，从临床记录和通信中识别出771名患者为潜在招募对象，并向她们发送了患者信息手册。在接受筛查的患者中，284名被认为符合条件，总体“筛查阳性”率为37%。各个中心筛查的人数在14至399人之间；“筛查阳性”率在22%至79%之间，符合条件的女性被招募的比例在55%至100%之间。这项额外的子研究的目的是探讨为什么在看似相似的地点之间“筛查阳性”率会有如此大的差异。
要求参与七个招募地点筛查的所有11名试验工作人员评估一系列20个相同的病例摘要，主要基于实际的全科医生转诊信。在这些病例摘要中，16个提到了一个或多个明确的纳入标准；其余的有可能的纳入情况。4个有明确的排除标准；12个有可能的排除情况。通过自由文本评论来澄清筛查人员的决定。对于6个病例摘要，每个人都认为患者符合条件；对于1个，所有人都认为她不符合条件；其余的情况意见不一。自由文本评论揭示了可能导致在判断潜在合格性方面存在差异的不确定性。
关于潜在试验合格性判断的差异凸显了明确和客观的纳入及排除标准的重要性，以及在信息缺失时做出判断的商定策略的重要性。在试验的开发和规划过程中，病例摘要可能是培训参与患者筛查和招募的人员、识别潜在问题以及确保合格标准应用更加一致的宝贵工具。
ISTCTN注册库：ISRCTN71327395，于2010年6月7日注册。
