Measurement of adherence in a randomised controlled trial of a complex intervention: supported self-management for adults with learning disability and type 2 diabetes

Abstract

BackgroundReporting adherence to intervention delivery and uptake is a detailed way of describing what was actually delivered and received, in comparison to what was intended. Measuring and reporting adherence is not routinely done well in complex interventions. The OK Diabetes trial (ISRCTN41897033) aimed to develop and subsequently test the feasibility of implementing a supported self-management intervention in adults with a learning disability and type 2 diabetes. A key study objective was to develop a measure of adherence to the intervention.MethodsWe conducted a systematic review of published literature, extracting data from included papers using a standardised proforma. We undertook a narrative synthesis of papers to determine the form and content of methods for adherence measurement for self-management interventions in this population that had already been developed. We used the framework and data extraction form developed for the review as the basis for an adherence measurement tool that we applied in the OK Diabetes trial.ResultsThe literature review found variability in the quality and content of adherence measurement and reporting, with no standardised approach. We were able to develop an adherence measure based upon the review, and populate it with data collected during the OK Diabetes trial. The adherence tool proved satisfactory for recording and measuring adherence in the trial.ConclusionThere remains a need for a standardised approach to adherence measurement in the field of complex interventions. We have shown that it is possible to produce a simple, feasible measure for assessing adherence in the OK Diabetes trial.Electronic supplementary materialThe online version of this article (doi:10.1186/s12874-016-0236-x) contains supplementary material, which is available to authorized users.

A multidimensional approach to assessing intervention fidelity in a process evaluation of audit and feedback interventions to reduce unnecessary blood transfusions: a study protocol

“…This is particularly important for fidelity investigations. While the BCC fidelity framework provides a synthesised conceptualisation and definition of different fidelity dimensions, the authors themselves acknowledge that there is little standardised guidance on how to operationalise each dimension, and a consequent need for further empirical examples of how each dimension has been quantified and interpreted [14, 38]. It is thus hoped that publishing the fidelity protocol and findings for the AFFINITIE process evaluation will provide a methodological contribution to the fidelity literature that may inform future fidelity assessments in other contexts.…”

Sun protection education for adolescents: a feasibility study of a wait-list controlled trial of an intervention involving a presentation, action planning, and SMS messages and using objective measurement of sun exposure

“…Reach and adherence can impact on statistical power and interpretation of trial results, including under-estimating any efficacy. There is no consensus on the acceptable minimum adherence level in trials and no standardised approach to adherence measurement in the field of complex interventions [52]. A review of treatment adherence in public health research reported that only 27% of research checked adherence to protocol [53] and few prior sun protection intervention studies have assessed reach and adherence.…”

Sun protection education for adolescents: A feasibility study of a wait-list controlled trial of an intervention involving a presentation, action planning, and SMS messages and using objective measurement of sun exposure

“…Reach and adherence can impact on statistical power and interpretation of trial results, including underestimating any efficacy. There is no consensus on the acceptable minimum adherence level in trials and no standardised approach to adherence measurement in the field of complex interventions [53].…”