Abstract

BackgroundPatient-reported outcomes are measured in many epidemiologic studies using self- or interviewer-administered questionnaires. While in some studies differences between these administration formats were observed, other studies did not show statistically significant differences important to patients. Since the evidence about the effect of administration format is inconsistent and mainly available from cross-sectional studies our aim was to assess the effects of different administration formats on repeated measurements of patient-reported outcomes in participants with AIDS enrolled in the Longitudinal Study of Ocular Complications of AIDS.MethodsWe included participants enrolled in the Longitudinal Study of Ocular Complications in AIDS (LSOCA) who completed the Medical Outcome Study [MOS] -HIV questionnaire, the EuroQol, the Feeling Thermometer and the Visual Function Questionnaire (VFQ) 25 every six months thereafter using self- or interviewer-administration. A large print questionnaire was available for participants with visual impairment. Considering all measurements over time and adjusting for patient and study site characteristics we used linear models to compare HRQL scores (all scores from 0-100) between administration formats. We defined adjusted differences of ≥0.2 standard deviations [SD]) to be quantitatively meaningful.ResultsWe included 2,261 participants (80.6% males) with a median of 43.1 years of age at enrolment who provided data on 23,420 study visits. The self-administered MOS-HIV, Feeling Thermometer and EuroQol were used in 70% of all visits and the VFQ-25 in 80%. For eight domains of the MOS-HIV differences between the interviewer- and self- administered format were < 0.1 SD. Differences in scores were highest for the social and role function domains but the adjusted differences were still < 0.2 SD. There was no quantitatively meaningful difference between administration formats for EuroQol, Feeling Thermometer and VFQ-25 domain scores. For ocular pain (VFQ-25), we found a statistically significant difference of 3.5 (95% CI 0.2, 6.8), which did, however, not exceed 0.2 SD. For all instruments scores were similar for the large and standard print formats with all adjusted differences < 0.2 SD.ConclusionsOur large study provides evidence that administration formats do not have a meaningful effect on repeated measurements of patient-reported outcomes. As a consequence, longitudinal studies may not need to consider the effect of different administration formats in their analyses.

Highlights

  • Patient-reported outcomes are measured in many epidemiologic studies using self- or intervieweradministered questionnaires

  • Study design and participants We included all participants enrolled in the Longitudinal Study of Ocular Complications of AIDS (LSOCA)

  • We considered all measurements and administration formats used over time and employed linear regression models ("regress” command of Stata) while accounting for within subject correlation ("cluster” option) and calculating robust standard errors using the Huber-White sandwich estimators ("robust” option)

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Summary

Introduction

Patient-reported outcomes are measured in many epidemiologic studies using self- or intervieweradministered questionnaires. Patient-reported outcomes (PRO) are measured in studies using information that is provided directly by study participants. Self-administered PRO questionnaires offer the advantage of not requiring research staff as interviewers and participants to complete the questionnaire at their own pace. It may be offered as a paperand pencil method both at the study site or at home (mail) or through web-based applications. Both self- and interviewer-administered questionnaires are available to accommodate preferences, physical impairment or literacy of participants [9,10]

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