Herrick Linda M, Locke Giles Richard, Schleck Cathy D, Zinsmeister Alan R, Treder Vickie, Talley Nicholas J
Division of Gastroenterology and Hepatology, Mayo Clinic , Rochester, MN , USA.
Scand J Gastroenterol. 2015 Aug;50(8):959-64. doi: 10.3109/00365521.2014.980317. Epub 2015 Mar 11.
OBJECTIVE: To assess the usefulness of a community-based mailed survey to identify participants with functional dyspepsia (FD) for a clinical trial. MATERIAL AND METHODS: In 2008, a valid self-report questionnaire of gastrointestinal symptoms required for diagnosis of FD was mailed to randomly selected cohorts of Olmsted County, Minnesota, residents. From survey responses (54%), FD cases and controls were identified. Phone calls were completed in 2010 and 2011 to 54% of respondents offering participation to those meeting criteria. RESULTS: Of 937 people identified from the survey, 189 cases and 265 controls were contacted by phone using four questions similar to the written survey resulting in a moderate level of agreement (Kappa 0.43, 95% CI: 0.35- 0.51; p = 0.11). The proportion reporting FD symptoms by survey was 42%, while the proportion by phone was 38%. Comparing classification of cases and controls, 118 (62%) survey cases had dyspepsia symptoms on phone screening while 53 (20%) of the survey controls reported FD symptoms. Of 171 who had symptoms, 60 (35%) declined, 33 (19%) were over study age limit, 24 (14%) had inadequate symptom levels and 36 (21%) had comorbidities. Of survey respondents contacted, six (3%) people were enrolled with two screen fails resulting in four (1%) randomized. CONCLUSION: Agreement between survey and phone questions was modest. Classifications between case and control changed. People eligible and willing to participate were a fraction of people reporting symptoms. People participating in clinical trials do not broadly represent those in the population.
目的:评估基于社区的邮寄调查问卷在识别功能性消化不良(FD)参与者以进行临床试验方面的效用。 材料与方法:2008年,将一份诊断FD所需的有效胃肠道症状自我报告问卷邮寄给明尼苏达州奥姆斯特德县随机抽取的居民队列。根据调查回复(54%)确定FD病例和对照。在2010年和2011年对54%的受访者进行电话随访,邀请符合标准者参与。 结果:从调查中识别出的937人中,通过电话联系了189例病例和265例对照,使用了四个与书面调查问卷类似的问题,一致性水平中等(Kappa 0.43,95%可信区间:0.35 - 0.51;p = 0.11)。通过调查报告FD症状的比例为42%,而通过电话报告的比例为38%。比较病例和对照的分类,118例(62%)调查病例在电话筛查时有消化不良症状,而53例(20%)调查对照报告有FD症状。在171名有症状的人中,60例(35%)拒绝参与,33例(19%)超过研究年龄限制,24例(14%)症状水平不足,36例(21%)有合并症。在接受电话随访的调查受访者中,6人(3%)入组,2次筛查失败,最终4人(1%)被随机分组。 结论:调查和电话问题之间的一致性一般。病例和对照的分类发生了变化。符合条件且愿意参与的人只是报告有症状人群中的一小部分。参与临床试验的人群并不能广泛代表总体人群。
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