EVAPIL-R Scale: Continuous Development and Validation of a Tool to Assess Patient-Reported Tolerability of Different Contraceptive Methods in Longitudinal Studies

Abstract Background Objective: The objective of this study was to modify the EVAPIL, a questionnaire designed to assess user-reported tolerability of combined oral contraceptives (COCs) in cross-sectional studies, to make it appropriate for assessing the tolerability of intrauterine systems (IUSs),...

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Bibliographic Details
Published in:Clinical therapeutics 2014-05, Vol.36 (5), p.638-647.e3
Main Authors: Clerson, Pierre, MD, Graesslin, Olivier, MD, Gater, Adam, MSc, Taylor, Fiona, MBiochem, Filonenko, Anna, DrPH, Schellschmidt, Ilka, MD, Rosen, Kimberly, MD
Format: Article
Language:English
Subjects:
Acne
Adolescent
Adult
adverse events
Birth control
Contraception - adverse effects
Contraceptive Agents, Female - adverse effects
Contraceptives, Oral, Combined - adverse effects
Cross-Sectional Studies
Databases, Bibliographic
Drug Implants - adverse effects
Female
France
Germany
Humans
Internal Medicine
Interviews
Interviews as Topic
Intrauterine Devices - adverse effects
intrauterine systems
Longitudinal Studies
Medical Education
Methods
Patient Compliance
patient-reported outcomes
Qualitative research
Software
Studies
subdermal implants
Surveys and Questionnaires
Transplants & implants
United States
Validation Studies as Topic
Womens health
Young Adult
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Summary:Abstract Background Objective: The objective of this study was to modify the EVAPIL, a questionnaire designed to assess user-reported tolerability of combined oral contraceptives (COCs) in cross-sectional studies, to make it appropriate for assessing the tolerability of intrauterine systems (IUSs), subdermal implants, and COCs in longitudinal studies. Methods Development of the EVAPIL-Revised (EVAPIL-R) was informed by a targeted literature review, qualitative interviews with IUS-prescribing gynecologists (n = 5), and IUS and implant users in the United States, Germany, and France (n = 36). Results Evidence generated supports the content validity of the EVAPIL-R for assessing user-reported tolerability of COCs, IUSs, and implants. Modifications to improve the relevance and usability of the questionnaire in longitudinal studies included specification of a defined recall period, addition of separate assessments of frequency and intensity (where relevant), and inclusion of additional items measuring concepts of importance to IUS and implant users (eg, vaginal discharge). Conclusions The EVAPIL-R is a valuable tool for use in research and clinical practice to identify tolerability concerns in hormonal contraceptive users. Future research will evaluate the psychometric validity and responsiveness of the EVAPIL-R. Understanding of user-reported tolerability of contraceptive methods is critical for facilitating patient adherence and potentially reducing the number of unintended pregnancies. The EVAPIL-R may be used to facilitate “women-centered” research and contraceptive counseling and provision.
ISSN:0149-2918
1879-114X
DOI:10.1016/j.clinthera.2014.04.008