子宫内膜异位症症状日记使用中的数据缺失模式。
Patterns of missing data in the use of the endometriosis symptom diary.
作者信息
Seitz Christian, Lanius Vivian, Lippert Susanne, Gerlinger Christoph, Haberland Claudia, Oehmke Frank, Tinneberg Hans-Rudolf
机构信息
Bayer AG, 13353, Berlin, Germany.
Department of Obstetrics and Gynecology, University of Saarland, Saarbrücken, Germany.
出版信息
BMC Womens Health. 2018 Jun 8;18(1):88. doi: 10.1186/s12905-018-0578-0.
BACKGROUND
Endometriosis is a common, chronic condition in women of reproductive age that is characterized by the presence of functional endometriotic lesions outside the uterus. The Endometriosis Symptom Diary (ESD) is an electronic patient-reported outcome (ePRO) instrument that assesses women's experience of endometriosis symptoms, with pain scored using a 0-10 numeric rating scale. This study investigated patterns of data missing from the ESD in the VALEPRO study.
METHODS
Post hoc analyses of missing data were conducted.
RESULTS
Of 272 participants using the ESD, 26.5% had no missing diary entries, 46.7% had > 0-5% of entries missing, 13.2% had > 5-10% of entries missing and 13.6% had > 10% of entries missing over the entire study period. The duration of missing episodes (defined as ≥1 consecutive days with missing diary entries) was generally short; most (81.4%) were 1 day. The difference in mean worst pain scores between missing and complete episodes per participant was - 0.1, suggesting that missing episodes were not related to severity of pain. Entries were significantly more likely to be missing on Fridays (18.5%) and Saturdays (22.9%) compared with other days of the week (p < 0.0001). Participants in the USA had significantly more long missing episodes than those in Germany (proportions of missing episodes longer than 1 day, 22.6 and 10.5%, respectively; p < 0.0001). The proportions of women with ≥1 missing entry were 50.0, 70.2 and 79.8% for women with elementary education, secondary education, and a college or university education, respectively. The proportions of women with ≥1 missing entry were similar for those with and without children (72.2 and 74.3%, respectively).
CONCLUSIONS
Most participants were highly compliant with entering data in the ESD and the amount of missing data was low. Entries were significantly more likely to be missing on Fridays and Saturdays compared with other days of the week, and participants in the USA had significantly more long missing episodes than participants in Germany.
TRIAL REGISTRATION
Clinicaltrials.gov, NCT01643122 , registered 4 July 2012.
背景
子宫内膜异位症是育龄期女性常见的慢性疾病，其特征是子宫外存在功能性子宫内膜异位病灶。子宫内膜异位症症状日记（ESD）是一种电子患者报告结局（ePRO）工具，用于评估女性子宫内膜异位症症状的体验，疼痛采用0至10的数字评分量表进行评分。本研究调查了VALEPRO研究中ESD缺失的数据模式。
方法
对缺失数据进行事后分析。
结果
在272名使用ESD的参与者中，26.5%没有日记条目缺失，46.7%有超过0至5%的条目缺失，13.2%有超过5至10%的条目缺失，13.6%在整个研究期间有超过10%的条目缺失。缺失发作的持续时间（定义为连续≥1天无日记条目）通常较短；大多数（81.4%）为1天。每位参与者缺失发作和完整发作之间的平均最严重疼痛评分差异为-0.1，表明缺失发作与疼痛严重程度无关。与一周中的其他日子相比，周五（18.5%）和周六（22.9%）日记条目缺失的可能性显著更高（p<0.0001）。美国的参与者比德国的参与者有更多的长时间缺失发作（缺失发作超过1天的比例分别为22.6%和10.5%；p<0.0001）。小学教育程度、中学教育程度以及大专或大学教育程度的女性中，有≥1条缺失条目的比例分别为50.0%、70.2%和79.8%。有孩子和没有孩子的女性中，有≥1条缺失条目的比例相似（分别为72.2%和74.3%）。
结论
大多数参与者在ESD中输入数据的依从性很高，缺失数据量较低。与一周中的其他日子相比，周五和周六日记条目缺失的可能性显著更高，并且美国的参与者比德国的参与者有更多的长时间缺失发作。
试验注册
Clinicaltrials.gov，NCT01643122，于2012年7月4日注册。
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