Choice of recall period for patient-reported outcome (PRO) measures: criteria for consideration

Choice of recall period for patient-reported outcome (PRO) measures: criteria for consideration
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DOI:
10.1007/s11136-011-0003-8
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发表时间:
2012-08-01
影响因子:
3.5
通讯作者:
Santanello, Nancy
Santanello, Nancy
中科院分区:
医学2区
文献类型:
--
作者:
Norquist, Josephine M.;Girman, Cynthia;Santanello, Nancy

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目的了解基于预期用途、疾病特征、治疗和研究属性的PRO指标回忆期的选择。(膀胱过度活动症、绝经期潮热、烟酸诱导的潮红、骨关节炎疼痛、肠易激症状、良性前列腺增生、结果使用不同的回忆期,包括事件驱动的(立即),每天,每周,每周以上,和更长的时间来确定脱发。这项工作表明:(1)回忆取决于PRO测量捕获的内容、其预期用途以及疾病和研究的属性;(2)在同一疾病区域内,回忆可能因感兴趣的概念或现象而异;(3)回忆必须考虑患者负担及其轻松准确回忆所需信息的能力;(4)回忆时间必须与试验持续时间和预定的门诊访视时间相一致。结论当症状有昼夜或日间波动时,较短的回忆时间可能低估症状负担,并可能给患者带来不必要的负担。另一方面,回忆间隔太长可能会高估或低估健康状况。因此,在选择适当的回忆期时,应考虑疾病的属性。
Purpose Understand the choice of recall period for PRO measures based on intended use, characteristics of the disease, treatment, and attributes of studies.Methods Current practice and considerations were reviewed within several disease areas (overactive bladder, menopausal hot flashes, niacin-induced flushing, osteoarthritis pain, irritable bowel symptoms, benign prostatic hyperplasia, and alopecia).Results Rationales were identified for using different recall periods, including event-driven (immediate), daily, up to weekly, and longer than weekly. This work demonstrates that (1) recall depends on what the PRO measure captures, its intended use, and attributes of the disease and study; (2) within the same disease area, recall can vary depending on the concept or phenomenon of interest; (3) recall must consider patient burden and their ability to easily and accurately recall the information requested; and (4) recall must be consistent with the duration of the trial and the scheduled clinic visits.Conclusions Shorter recall periods may underestimate symptom burden when symptoms have diurnal or day-today fluctuation and may place undue burden on patients. On the other hand, recall intervals that are too long may either over-or underestimate the health state. Therefore, appropriate criteria should be considered given attributes of the disease when selecting an adequate recall period.