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

Abstract

ObjectiveTo 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.DesignSystematic review and meta-analysis.Data sourcesOvid Medline, Ovid Embase, Web of Science and CINAHL from 1 January 2013 to 31 December 2018.Eligibility criteria for selecting studiesRCTs 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.Main outcome measureChange in medication adherence.ResultsOf 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<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.ConclusionsIn 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.PROSPERO registration numberCRD42017059460.

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“…HbA1c levels improved significantly (0.15% to 1.74% lower) with the use of food supplementation with referral and diabetes support, financial incentives with education and skills training, the use of housing relocation with counselling support (4.3% lower DM prevalence after 10 to 15 years of follow-up), and the integration of nonmedical interventions into medical care using the electronic medical record [44]. Multifaceted versus single-faceted interventions in other studies also led to statistically significant improvements in the odds of medication adherence in diabetes care (subgroup analysis: odds ratio, 2.05; 95% confidence interval, 1.62 to 2.60; P=0.010) [45]. Efficient and effective care management, and patient education interventions require multidisciplinary approaches and coordination [23].…”

Estimated Thresholds of Minimum Necessary Adherence for Effective Treatment with Direct Oral Anticoagulants – A Retrospective Cohort Study in Health Insurance Claims Data

“…We considered the meta-analytically pooled odds ratio of 1.57 for achieving “good” adherence. 37 First, each patient was randomly assigned an adherence according to the reference distribution. Then, we randomly sampled 57% of the patients below the cut-off, assigned the cut-off value to their adherence estimate, and predicted the number of events depending on the new adherence values.…”

Medication Adherence in Cardiovascular Diseases

“…They were classified partly or wholly into several categories of intervention: patient education, behavioral interventions, using reminder tools, cost reduction, and financial aid, using a healthcare team, and using fixed-dose therapy (polypill). Multifaceted interventions appeared more effective than single ones [63,64]. This can partly be explained by the multifaceted nature of factors influencing medication adherence.…”