Patient compliance with paper and electronic diaries

Patient compliance with paper and electronic diaries
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DOI:
10.1016/s0197-2456(02)00320-3
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发表时间:
2003-04-01
期刊:
CONTROLLED CLINICAL TRIALS
影响因子:
--
通讯作者:
Hufford, MR
Hufford, MR
中科院分区:
其他
文献类型:
--
作者:
Stone, AA;Shiffman, S;Hufford, MR

文献摘要

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纸质日记通常用于医疗保健和临床研究,以评估患者的经历。人们担心患者不遵守日记方案,可能使日记数据的益处无效。纸质日记的依从性通过纸质日记和包含依从性增强功能的电子日记进行检查。参与者是慢性疼痛患者,他们被分配使用纸质日记工具来跟踪日记使用或电子日记,时间戳条目。参与者被指示在连续21天的预定时间每天进行三次疼痛输入。主要结局指标报告与纸质日记的实际依从性和纸质日记的实际依从性(通过比较日记使用的书面时间和电子记录时间定义)。通过电子日志记录实际依从性。参与者提交了对应于90%指定时间(+/-15分钟)的日记卡。然而,电子记录显示,实际遵守率仅为11%,表明虚假遵守率很高。在所有研究日的32%,纸质日记夹未打开,但这些研究日报告的依从性超过90%。对于电子日记,实际遵守率为94%。总之,参加研究的慢性疼痛参与者不依从纸质日记,但依从具有增强依从性特征的电子日记。研究结果对纸质日记的使用提出了质疑,并建议具有增强依从性功能的电子日记是收集日记信息的更有效方式。(C)2003年爱思唯尔科学公司All rights reserved.
Paper diaries are commonly used in health care and clinical research to assess patient experiences. There is concern that patients do not comply with diary protocols, possibly invalidating the benefit of diary data. Compliance with paper diaries was examined with a paper diary and with an electronic diary that incorporated compliance-enhancing features. Participants were chronic pain patients and they were assigned to use either a paper diary instrumented to track diary use or an electronic diary that time-stamped entries. Participants were instructed to make three pain entries per day at predetermined times for 21 consecutive days. Primary outcome measures were reported vs actual compliance with paper diaries and actual compliance with paper diaries (defined by comparing the written times and the electronically-recorded times of diary use). Actual compliance was recorded by the electronic diary. Participants submitted diary cards corresponding to 90% of assigned times (+/-15 min). However, electronic records indicated that actual compliance was only 11%, indicating a high level of faked compliance. On 32% of all study days the paper diary binder was not opened, yet reported compliance for these days exceeded 90%. For the electronic diary, the actual compliance rate was 94%. In summary, participants with chronic pain enrolled in a study for research were not compliant with paper diaries but were compliant with an electronic diary with enhanced compliance features. The findings call into question the use of paper diaries and suggest that electronic diaries with compliance-enhancing features are a more effective way of collecting diary information. (C) 2003 Elsevier Science Inc. All rights reserved.