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Quality of Life Research
Gepubliceerd in:

01-11-2014

The validity of a patient-reported adverse drug event questionnaire using different recall periods

Auteurs: Sieta T. de Vries, Flora M. Haaijer-Ruskamp, Dick de Zeeuw, Petra Denig

Gepubliceerd in: Quality of Life Research | Uitgave 9/2014

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Abstract

Purpose

To assess the validity of a patient-reported adverse drug events (ADEs) questionnaire with a 3-month or 4-week recall period.

Methods

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.

Results

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.

Conclusions

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.
vorige artikel Mapping the content of the Patient-Reported Outcomes Measurement Information System (PROMIS®) using the International Classification of Functioning, Health and Disability
volgende artikel Psychometric properties of a brief, clinically relevant measure of pain in patients with hepatocellular carcinoma
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Metagegevens
Titel
The validity of a patient-reported adverse drug event questionnaire using different recall periods
Auteurs
Sieta T. de Vries
Flora M. Haaijer-Ruskamp
Dick de Zeeuw
Petra Denig
Publicatiedatum
01-11-2014
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 9/2014
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-014-0715-7

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