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

Objective 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 categ...

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Main Authors: Clare Gillies, Samuel Seidu, Claire Fitzpatrick, Debasish Kar, Ekaterini Ioannidou, Prashanth Patel, Pankaj Gupta
Format: Article
Language:English
Published: BMJ Publishing Group 2020-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/7/e036575.full
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author Clare Gillies
Samuel Seidu
Claire Fitzpatrick
Debasish Kar
Ekaterini Ioannidou
Prashanth Patel
Pankaj Gupta
author_facet Clare Gillies
Samuel Seidu
Claire Fitzpatrick
Debasish Kar
Ekaterini Ioannidou
Prashanth Patel
Pankaj Gupta
author_sort Clare Gillies
collection DOAJ
description Objective 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.Design Systematic review and meta-analysis.Data sources Ovid Medline, Ovid Embase, Web of Science and CINAHL from 1 January 2013 to 31 December 2018.Eligibility criteria for selecting studies 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.Main outcome measure Change in medication adherence.Results 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<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.Conclusions 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.PROSPERO registration number CRD42017059460.
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spelling doaj-art-24d2dafccec14b04be3a3ed638b3549b2024-12-04T15:00:10ZengBMJ Publishing GroupBMJ Open2044-60552020-07-0110710.1136/bmjopen-2019-036575Effect of pragmatic versus explanatory interventions on medication adherence in people with cardiometabolic conditions: a systematic review and meta-analysisClare Gillies0Samuel Seidu1Claire Fitzpatrick2Debasish Kar3Ekaterini Ioannidou4Prashanth Patel5Pankaj Gupta6Diabetes Research Centre, University of Leicester, Leicester, UKDiabetes Research Centre, College of Life Sciences, University of Leicester, Leicester, UKDiabetes Research Centre, University of Leicester, Leicester, UKDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, UKDiabetes Research Centre, University of Leicester, Leicester, UKDepartment of Cardiovascular Sciences, University of Leicester, Leicester, Leicestershire, UKPostgraduate Institute of Medical Education and Research, Chandigarh, IndiaObjective 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.Design Systematic review and meta-analysis.Data sources Ovid Medline, Ovid Embase, Web of Science and CINAHL from 1 January 2013 to 31 December 2018.Eligibility criteria for selecting studies 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.Main outcome measure Change in medication adherence.Results 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<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.Conclusions 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.PROSPERO registration number CRD42017059460.https://bmjopen.bmj.com/content/10/7/e036575.full
spellingShingle Clare Gillies
Samuel Seidu
Claire Fitzpatrick
Debasish Kar
Ekaterini Ioannidou
Prashanth Patel
Pankaj Gupta
Effect of pragmatic versus explanatory interventions on medication adherence in people with cardiometabolic conditions: a systematic review and meta-analysis
BMJ Open
title Effect of pragmatic versus explanatory interventions on medication adherence in people with cardiometabolic conditions: a systematic review and meta-analysis
title_full Effect of pragmatic versus explanatory interventions on medication adherence in people with cardiometabolic conditions: a systematic review and meta-analysis
title_fullStr Effect of pragmatic versus explanatory interventions on medication adherence in people with cardiometabolic conditions: a systematic review and meta-analysis
title_full_unstemmed Effect of pragmatic versus explanatory interventions on medication adherence in people with cardiometabolic conditions: a systematic review and meta-analysis
title_short Effect of pragmatic versus explanatory interventions on medication adherence in people with cardiometabolic conditions: a systematic review and meta-analysis
title_sort effect of pragmatic versus explanatory interventions on medication adherence in people with cardiometabolic conditions a systematic review and meta analysis
url https://bmjopen.bmj.com/content/10/7/e036575.full
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