Effect of pragmatic versus explanatory interventions on medication adherence in people with cardiometabolic conditions: a systematic review and meta-analysis

Abstract

<jats:sec><jats:title>Objective</jats:title><jats:p>To synthesise findings from randomised controlled trials (RCTs) of interventions aimed at increasing medication adherence in individuals with type 2 diabetes (T2DM) and/or cardiovascular disease (CVD). And, in a novel approach, to compare the intervention effect of studies which were categorised as being more pragmatic or more explanatory using the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool, to identify whether study design affects outcomes. As explanatory trials are typically held under controlled conditions, findings from such trials may not be relatable to real-world clinical practice. In comparison, pragmatic trials are designed to replicate real-world conditions and therefore findings are more likely to represent those found if the intervention were to be implemented in routine care.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Systematic review and meta-analysis.</jats:p></jats:sec><jats:sec><jats:title>Data sources</jats:title><jats:p>Ovid Medline, Ovid Embase, Web of Science and CINAHL from 1 January 2013 to 31 December 2018.</jats:p></jats:sec><jats:sec><jats:title>Eligibility criteria for selecting studies</jats:title><jats:p>RCTs lasting ≥3 months (90 days), involving ≥200 patients in the analysis, with either established CVD and/or T2DM and which measured medication adherence. From 4403 citations, 103 proceeded to full text review. Studies published in any language other than English and conference abstracts were excluded.</jats:p></jats:sec><jats:sec><jats:title>Main outcome measure</jats:title><jats:p>Change in medication adherence.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 4403 records identified, 34 studies were considered eligible, of which 28, including 30 861 participants, contained comparable outcome data for inclusion in the meta-analysis. Overall interventions were associated with an increase in medication adherence (OR 1.57 (95% CI: 1.33 to 1.84), p&lt;0.001; standardised mean difference 0.24 (95% CI: −0.10 to 0.59) p=0.101). The effectiveness of interventions did not differ significantly between studies considered pragmatic versus explanatory (p=0.598), but did differ by intervention type, with studies that included a multifaceted rather than a single-faceted intervention having a more significant effect (p=0.010). The analysis used random effect models and used the revised Cochrane Risk of Bias Tool to assess study quality.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>In this meta-analysis, interventions were associated with a significant increase in medication adherence. Overall multifaceted interventions which included an element of education alongside regular patient contact or follow-up showed the most promise. Effectiveness of interventions between pragmatic and explanatory trials was comparable, suggesting that findings can be transferred from idealised to real-word conditions.</jats:p></jats:sec><jats:sec><jats:title>PROSPERO registration number</jats:title><jats:p>CRD42017059460.</jats:p></jats:sec>