A Proposal for Quality Standards for Measuring Medication Adherence in Research

Abstract

A decade after widespread recognition that adherence to medication regimens is key to antiretroviral (ARV) effectiveness, considerable controversy remains regarding a “gold standard” for adherence measurement. Each adherence measurement approach has strengths and weaknesses and each rests on specific assumptions. The range of assumptions regarding adherence measurement and the diversity with which each approach is implemented strongly suggest that the evaluation of a particular measure outside of the context in which it was used (e.g. the study’s operational protocol) may result in undeserved confidence or lack of confidence in study results. The purpose of this paper is to propose a set of best practices across commonly used measurement methods. Recommendations regarding what information should be included in published reports regarding how adherence was measured are provided to promote improvement in the quality of measurement of medication adherence in research.

Self-report measures of medication adherence behavior: recommendations on optimal use

“…Among comparisons that were not highly concordant, self-reports produced higher estimates of adherence than other assessment methods 92 % of the time (45 out of 49 comparisons). A meta-analysis showed the estimated degree of regimen execution is approximately 15 % higher by self-report when compared with EDM devices [56], which is consonant with estimates in other reviews and syntheses [5,35,56,58].…”

“…Among comparisons that were not highly concordant, self-reports produced higher estimates of adherence than other assessment methods 92 % of the time (45 out of 49 comparisons). A meta-analysis showed the estimated degree of regimen execution is approximately 15 % higher by self-report when compared with EDM devices [56], which is consonant with estimates in other reviews and syntheses [5,35,56,58].Sensitivity and specificity-Because of potential overreporting, self-report adherence measures are considered to have good specificity (i.e., positive predictive value) and weak sensitivity (i.e., negative predictive value) for detecting poor adherence [5,32,46]. Stated simply, self-reports of nonadherence can be trusted; self-reports of adherence less so.…”

“…It is recommended that researchers and clinicians select a self-report measure that has prior validation data within the relevant chronic illness area and preferably one that has demonstrated both concurrent and criterion validity [35]. To help improve available information on measures, adherence-related publications should include a clear description of any self-report measure and its administration method, along with descriptive data resulting from the measure (e.g., mean, median, standard deviation) [9,35]. Define the adherence construct you want to assess-It is important to define the specific construct of interest when conducting medication adherence assessments and to select an appropriately corresponding measure [7,52,59,60].…”

Desirability and feasibility of wireless electronic monitoring of medications in clinical trials

“…It also consumes additional staff time and resources to address the NA [22,23]. Such concerns lead some researchers to advocate for developing uniform standards for reporting on adherence in clinical trials akin to the Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting on data and recruitment [18,24]. Monitoring medication taking is a common strategy used to assess and promote regimen adherence in clinical research [3].…”

“…Although none of these metrics related to patient medication use can be presumed to provide definitive accounting of actual medication ingestion (i.e., they all have limitations and are based on certain assumptions), they generally provide valuable insights into how consistently patients take their medications compared to their prescription. Relative advantages and limitations of monitoring approaches have been discussed elsewhere [24,28] and warrant the consideration of clinical researchers.…”