de Vries Sieta T, Haaijer-Ruskamp Flora M, de Zeeuw Dick, Denig Petra
Department of Clinical Pharmacy and Pharmacology (FB20), University of Groningen, University Medical Center Groningen, PO Box 196, 9700 AD, Groningen, The Netherlands.
Qual Life Res. 2014 Nov;23(9):2439-45. doi: 10.1007/s11136-014-0715-7. Epub 2014 May 22.
To assess the validity of a patient-reported adverse drug events (ADEs) questionnaire with a 3-month or 4-week recall period.
Patients receiving at least one oral glucose-lowering drug were asked to report potential ADEs they experienced related to any drug in a daily diary for a 3-month period. Thereafter, they completed the ADE questionnaire with either a 3-month or 4-week recall period. The validity was assessed by comparing ADEs reported in each version with those reported in the diary at class level and at specific ADE level. At class level, a comparison was made using (1) primary system organ classes (SOCs) of the medical dictionary for regulatory activities and (2) other related SOCs. Sensitivity and positive predictive value (PPV) were calculated.
Each version of the questionnaire was completed by 39 patients. In the 3-month group, 21 patients reported 70 ADEs in the diary. In the 4-week group, six patients reported seven ADEs in the last 4 weeks of the diary. Sensitivity to assess ADEs at primary SOC was low for both recall groups (33 %). PPV was 51 and 10 % for, respectively, the 3-month and 4-week group. Taking other related SOCs into account slightly increased the sensitivity for the 3-month group (38%). Sensitivity of reporting the same ADE was 41 and 43 % for, respectively, the 3-month and 4-week group.
Regardless of the recall period and level of comparison, the validity for assessing ADEs was low with the patient-reported ADE questionnaire. Further refinement is needed to improve the validity.
评估一份回忆期为3个月或4周的患者报告的药物不良事件（ADEs）问卷的有效性。
要求接受至少一种口服降糖药物治疗的患者在一份日常日记中记录他们在3个月内经历的与任何药物相关的潜在ADEs。此后，他们完成回忆期为3个月或4周的ADE问卷。通过比较每个版本报告的ADEs与日记中按类别水平和特定ADE水平报告的ADEs来评估有效性。在类别水平上，使用（1）用于监管活动的医学词典的主要系统器官类别（SOCs）和（2）其他相关SOCs进行比较。计算敏感性和阳性预测值（PPV）。
每个版本的问卷均由39名患者完成。在3个月组中，21名患者在日记中报告了70起ADEs。在4周组中，6名患者在日记的最后4周报告了7起ADEs。两个回忆组在主要SOC评估ADEs的敏感性均较低（33%）。3个月组和4周组的PPV分别为51%和10%。考虑其他相关SOCs后，3个月组的敏感性略有提高（38%）。3个月组和4周组报告相同ADE的敏感性分别为41%和43%。
无论回忆期和比较水平如何，患者报告的ADE问卷评估ADEs的有效性都较低。需要进一步完善以提高有效性。
