BACKGROUND: Lipid-lowering drugs are widely underused, despite strong evidence indicating they improve cardiovascular end points. Poor patient adherence to a medication regimen can affect the success of lipid-lowering treatment.
OBJECTIVES: To assess the effects of interventions aimed at improving adherence to lipid-lowering drugs, focusing on measures of adherence and clinical outcomes.
SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO and CINAHL up to 3 February 2016, and clinical trials registers (ANZCTR and ClinicalTrials.gov) up to 27 July 2016. We applied no language restrictions.
SELECTION CRITERIA: We evaluated randomised controlled trials of adherence-enhancing interventions for lipid-lowering medication in adults in an ambulatory setting with a variety of measurable outcomes, such as adherence to treatment and changes to serum lipid levels. Two teams of review authors independently selected the studies.
DATA COLLECTION AND ANALYSIS: Three review authors extracted and assessed data, following criteria outlined by the Cochrane Handbook for Systematic Reviews of Interventions. We assessed the quality of the evidence using GRADEPro.
MAIN RESULTS: For this updated review, we added 24 new studies meeting the eligibility criteria to the 11 studies from prior updates. We have therefore included 35 studies, randomising 925,171 participants. Seven studies including 11,204 individuals compared adherence rates of those in an intensification of a patient care intervention (e.g. electronic reminders, pharmacist-led interventions, healthcare professional education of patients) versus usual care over the short term (six months or less), and were pooled in a meta-analysis. Participants in the intervention group had better adherence than those receiving usual care (odds ratio (OR) 1.93, 95% confidence interval (CI) 1.29 to 2.88; 7 studies; 11,204 participants; moderate-quality evidence). A separate analysis also showed improvements in long-term adherence rates (more than six months) using intensification of care (OR 2.87, 95% CI 1.91 to 4.29; 3 studies; 663 participants; high-quality evidence). Analyses of the effect on total cholesterol and LDL-cholesterol levels also showed a positive effect of intensified interventions over both short- and long-term follow-up. Over the short term, total cholesterol decreased by a mean of 17.15 mg/dL (95% CI 1.17 to 33.14; 4 studies; 430 participants; low-quality evidence) and LDL-cholesterol decreased by a mean of 19.51 mg/dL (95% CI 8.51 to 30.51; 3 studies; 333 participants; moderate-quality evidence). Over the long term (more than six months) total cholesterol decreased by a mean of 17.57 mg/dL (95% CI 14.95 to 20.19; 2 studies; 127 participants; high-quality evidence). Included studies did not report usable data for health outcome indications, adverse effects or costs/resource use, so we could not pool these outcomes. We assessed each included study for bias using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. In general, the risk of bias assessment revealed a low risk of selection bias, attrition bias, and reporting bias. There was unclear risk of bias relating to blinding for most studies.
AUTHORS' CONCLUSIONS: The evidence in our review demonstrates that intensification of patient care interventions improves short- and long-term medication adherence, as well as total cholesterol and LDL-cholesterol levels. Healthcare systems which can implement team-based intensification of patient care interventions may be successful in improving patient adherence rates to lipid-lowering medicines.
BACKGROUND: People who are prescribed self administered medications typically take only about half their prescribed doses. Efforts to assist patients with adherence to medications might improve the benefits of prescribed medications.
OBJECTIVES: The primary objective of this review is to assess the effects of interventions intended to enhance patient adherence to prescribed medications for medical conditions, on both medication adherence and clinical outcomes.
SEARCH METHODS: We updated searches of The Cochrane Library, including CENTRAL (via http://onlinelibrary.wiley.com/cochranelibrary/search/), MEDLINE, EMBASE, PsycINFO (all via Ovid), CINAHL (via EBSCO), and Sociological Abstracts (via ProQuest) on 11 January 2013 with no language restriction. We also reviewed bibliographies in articles on patient adherence, and contacted authors of relevant original and review articles.
SELECTION CRITERIA: We included unconfounded RCTs of interventions to improve adherence with prescribed medications, measuring both medication adherence and clinical outcome, with at least 80% follow-up of each group studied and, for long-term treatments, at least six months follow-up for studies with positive findings at earlier time points.
DATA COLLECTION AND ANALYSIS: Two review authors independently extracted all data and a third author resolved disagreements. The studies differed widely according to medical condition, patient population, intervention, measures of adherence, and clinical outcomes. Pooling results according to one of these characteristics still leaves highly heterogeneous groups, and we could not justify meta-analysis. Instead, we conducted a qualitative analysis with a focus on the RCTs with the lowest risk of bias for study design and the primary clinical outcome.
MAIN RESULTS: The present update included 109 new RCTs published since the previous update in January 2007, bringing the total number of RCTs to 182; we found five RCTs from the previous update to be ineligible and excluded them. Studies were heterogeneous for patients, medical problems, treatment regimens, adherence interventions, and adherence and clinical outcome measurements, and most had high risk of bias. The main changes in comparison with the previous update include that we now: 1) report a lack of convincing evidence also specifically among the studies with the lowest risk of bias; 2) do not try to classify studies according to intervention type any more, due to the large heterogeneity; 3) make our database available for collaboration on sub-analyses, in acknowledgement of the need to make collective advancement in this difficult field of research. Of all 182 RCTs, 17 had the lowest risk of bias for study design features and their primary clinical outcome, 11 from the present update and six from the previous update. The RCTs at lowest risk of bias generally involved complex interventions with multiple components, trying to overcome barriers to adherence by means of tailored ongoing support from allied health professionals such as pharmacists, who often delivered intense education, counseling (including motivational interviewing or cognitive behavioral therapy by professionals) or daily treatment support (or both), and sometimes additional support from family or peers. Only five of these RCTs reported improvements in both adherence and clinical outcomes, and no common intervention characteristics were apparent. Even the most effective interventions did not lead to large improvements in adherence or clinical outcomes.
AUTHORS' CONCLUSIONS: Across the body of evidence, effects were inconsistent from study to study, and only a minority of lowest risk of bias RCTs improved both adherence and clinical outcomes. Current methods of improving medication adherence for chronic health problems are mostly complex and not very effective, so that the full benefits of treatment cannot be realized. The research in this field needs advances, including improved design of feasible long-term interventions, objective adherence measures, and sufficient study power to detect improvements in patient-important clinical outcomes. By making our comprehensive database available for sharing we hope to contribute to achieving these advances.
BACKGROUND: Because of the improvement of the pharmacological and non-pharmacological treatment in heart failure (HF) patients, the HF related therapeutic regimen is becoming more complicated. Non-compliance with this regimen can result in worsening HF symptoms, sometimes leading to hospitalisation.
AIMS: The aims of this systematic literature review are (1) to describe the consequences of non-compliance in HF patients; (2) to summarise the degree of compliance in the various aspects of the therapeutic regimen; and (3) to review interventions that are recommended to improve compliance in HF patients.
METHODS: A literature search of the MEDLINE and CINAHL database from 1988 to June 2003 was performed. Studies on compliance with life style recommendations according to the HF Guidelines of the European Society of Cardiology and the American Heart Association/American College of Cardiology were included.
CONCLUSION: Non-compliance with medication and other lifestyle recommendations is a major problem in patients with HF. Evidence based interventions to improve compliance in patients with HF are scarce. Interventions that can increase compliance and prevent HF related readmissions in order to improve the quality of life of patients with HF need to be developed and tested.
BACKGROUND: Research suggests adherence to treatment recommendations is low. In type 2 diabetes, which is a chronic condition slowly leading to serious vascular, nephrologic, neurologic and ophthalmological complications, it can be assumed that enhancing adherence to treatment recommendations may lead to a reduction of complications. Treatment regimens in type 2 diabetes are complicated, encompassing life-style adaptations and medication intake.
OBJECTIVES: To assess the effects of interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus.
SEARCH STRATEGY: Studies were obtained from searches of multiple electronic bibliographic databases supplemented with hand searches of references.
SELECTION CRITERIA: Randomised controlled and controlled clinical trials, before-after studies and epidemiological studies, assessing changes in adherence to treatment recommendations, as defined in the objectives section, were included.
DATA COLLECTION AND ANALYSIS: Two teams of reviewers independently assessed the trials identified for inclusion. Three teams of two reviewers assessed trial quality and extracted data. The analysis for the narrative part was performed by one reviewer (EV), the meta-analysis by two reviewers (EV, JW).
MAIN RESULTS: Twenty-one studies assessing interventions aiming at improving adherence to treatment recommendations, not to diet or exercise recommendations, in people living with type 2 diabetes in primary care, outpatient settings, community and hospital settings, were included. Outcomes evaluated in these studies were heterogeneous, there was a variety of adherence measurement instruments. Nurse led interventions, home aids, diabetes education, pharmacy led interventions, adaptation of dosing and frequency of medication taking showed a small effect on a variety of outcomes including HbA1c. No data on mortality and morbidity, nor on quality of life could be found.
AUTHORS' CONCLUSIONS: Current efforts to improve or to facilitate adherence of people with type 2 diabetes to treatment recommendations do not show significant effects nor harms. The question whether any intervention enhances adherence to treatment recommendations in type 2 diabetes effectively, thus still remains unanswered.
OBJECTIVE: To examine the tolerability of single versus multiple daily dosing (SDD vs. MDD) of antidepressant drugs in clinical practice.
METHOD: Studies comparing single versus multiple daily dosing of antidepressants were reviewed. Since there were no numeric data available on the rates of adverse events for the SDD versus MDD arms, meta-analyses were carried out to compare rates of study completers (or rates of drop-outs) with single versus multiple daily dosing.
RESULTS: The review process identified 22 studies meeting our inclusion criteria. This meta-analysis found no difference in the rates of study completers with SDD or MDD regime of antidepressants.
CONCLUSION: Our analysis on rates of completers (or rates of drop-outs) gives us an estimation of the overall acceptability of treatment and of course, but has limited utility when compared to the rates of adverse events. Yet, the present analyses suggest that adverse events which are significant enough to result in drop-outs, are not more frequent with SDD than MDD. MDD strategy of antidepressants does not seem to be more advantageous for the acceptability of treatment and obviously is disadvantageous for compliance. Thus, a simplified treatment regimen may be practical to increase treatment success rates in depression.
Adequate adherence to medication regimens is central to the successful treatment of communicable and noncommunicable disease. Fixed-dose combination pills and unit-of-use packaging are therapy-related interventions that are designed to simplify medication regimens and so potentially improve adherence. We conducted a systematic review of relevant randomized trials in order to quantify the effects of fixed-dose combination pills and unit-of-use packaging, compared with medications as usually presented, in terms of adherence to treatment and improved outcomes. Only 15 trials met the inclusion criteria; fixed-dose combination pills were investigated in three of these, while unit-of-use packaging was studied in 12 trials. The trials involved treatments for communicable diseases (n = 5), blood pressure lowering medications (n = 3), diabetic patients (n = 1), vitamin supplementation (n = 1) and management of multiple medications by the elderly (n = 5). The results of the trials suggested that there were trends towards improved adherence and/or clinical outcomes in all but three of the trials; this reached statistical significance in four out of seven trials reporting a clinically relevant or intermediate end-point, and in seven out of thirteen trials reporting medication adherence. Measures of outcome were, however, heterogeneous, and interpretation was further limited by methodological issues, particularly small sample size, short duration and loss to follow-up. Overall, the evidence suggests that fixed-dose combination pills and unit-of-use packaging are likely to improve adherence in a range of settings, but the limitations of the available evidence means that uncertainty remains about the size of these benefits.
In a review of the literature from 1948 to 2001, 122 studies were found that correlated structural or functional social support with patient adherence to medical regimens. Meta-analyses establish significant average r-effect sizes between adherence and practical, emotional, and unidimensional social support; family cohesiveness and conflict; marital status; and living arrangement of adults. Substantive and methodological variables moderate these effects. Practical support bears the highest correlation with adherence. Adherence is 1.74 times higher in patients from cohesive families and 1.53 times lower in patients from families in conflict. Marital status and living with another person (for adults) increase adherence modestly. A research agenda is recommended to further examine mediators of the relationship between social support and health.
BACKGROUND: Non-adherence is a common cause of treatment failure. The causes and context of non-adherence may differ amongst older people and reviews of interventions to improve adherence have tended to focus on the younger adult population. OBJECTIVE: To conduct a systematic review of interventions to aid adherence to medication for older people over the age of 65. METHOD: Relevant papers identified by searching the Cochrane Database of Systematic Reviews and the Database of Abstracts of Review of Effectiveness (Cochrane Library), Medline 1966-October 2002, Embase 1980-October 2002, Best Evidence, PsychINFO 1887-October 2002 and CINAHL 1982-October 2002. These were then hand-searched. The papers that fitted our inclusion criteria were selected. Two independent reviewers using an established tool assessed the studies for methodological quality. A non-statistical narrative approach was then taken to analyse the studies due to the heterogeneity of the outcome measures. RESULTS: 7 studies were identified. They used a variety of approaches involving external cognitive supports and/or educational interventions. Most studies were of poor methodological quality. Statistically significant effects, where present, tended to have small effects clinically. CONCLUSIONS: Currently there is no strong evidence to support the use of any one intervention type. Future research should use combinations of approaches, as there is some evidence that these are more likely to be successful.
OBJECTIVE: To identify methods targeted at improving adherence to antihypertensives and determine their effect on adherence using meta-analytic techniques. METHODS: A literature search from 1970 to December 2000 using MEDLINE, International Pharmaceutical Abstracts, PsychLit, ERIC, and EMBASE was performed using the terms compliance, adherence, and medication. Randomized articles with an intervention directed at a patient/caregiver, a comparator group, and a minimum of 10 subjects in each intervention group were identified by 3 independent reviewers. Articles that did not report sample size data or adequate results of the intervention were excluded. Sixteen citations focusing on antihypertensive adherence were identified. Of the 16 citations, 6 studied either more than one intervention in the same population or different interventions in different patient populations, yielding 24 cohorts with 2446 patients. RESULTS: Fifty-eight percent of the methods focused on behavioral interventions (BIs), 29% studied the effect of a combination of behavioral and educational interventions (BEIs), and 13% utilized educational interventions (EIs) alone. Overall, the study groups were nonhomogenous (Q = 183.92; p < 0.001). However, when the groups were separated by the intervention type, the BIs were homogenous (Q = 1.19; p = 1.00) with an overall effect size (ES) of 0.04 (95% CI -0.01 to -0.09), indicating a trend toward improved adherence. Fifty percent of the BIs were performed in the physician's office; however, setting did not influence the intervention's impact (p = 0.13). Within the BIs, no single intervention improved adherence over others. CONCLUSIONS: Based on the interventions included in this meta-analysis, there is no single intervention that improves adherence to antihypertensives over others; therefore, a patient-specific approach should be modeled.
Lipid-lowering drugs are widely underused, despite strong evidence indicating they improve cardiovascular end points. Poor patient adherence to a medication regimen can affect the success of lipid-lowering treatment.
OBJECTIVES:
To assess the effects of interventions aimed at improving adherence to lipid-lowering drugs, focusing on measures of adherence and clinical outcomes.
SEARCH METHODS:
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO and CINAHL up to 3 February 2016, and clinical trials registers (ANZCTR and ClinicalTrials.gov) up to 27 July 2016. We applied no language restrictions.
SELECTION CRITERIA:
We evaluated randomised controlled trials of adherence-enhancing interventions for lipid-lowering medication in adults in an ambulatory setting with a variety of measurable outcomes, such as adherence to treatment and changes to serum lipid levels. Two teams of review authors independently selected the studies.
DATA COLLECTION AND ANALYSIS:
Three review authors extracted and assessed data, following criteria outlined by the Cochrane Handbook for Systematic Reviews of Interventions. We assessed the quality of the evidence using GRADEPro.
MAIN RESULTS:
For this updated review, we added 24 new studies meeting the eligibility criteria to the 11 studies from prior updates. We have therefore included 35 studies, randomising 925,171 participants. Seven studies including 11,204 individuals compared adherence rates of those in an intensification of a patient care intervention (e.g. electronic reminders, pharmacist-led interventions, healthcare professional education of patients) versus usual care over the short term (six months or less), and were pooled in a meta-analysis. Participants in the intervention group had better adherence than those receiving usual care (odds ratio (OR) 1.93, 95% confidence interval (CI) 1.29 to 2.88; 7 studies; 11,204 participants; moderate-quality evidence). A separate analysis also showed improvements in long-term adherence rates (more than six months) using intensification of care (OR 2.87, 95% CI 1.91 to 4.29; 3 studies; 663 participants; high-quality evidence). Analyses of the effect on total cholesterol and LDL-cholesterol levels also showed a positive effect of intensified interventions over both short- and long-term follow-up. Over the short term, total cholesterol decreased by a mean of 17.15 mg/dL (95% CI 1.17 to 33.14; 4 studies; 430 participants; low-quality evidence) and LDL-cholesterol decreased by a mean of 19.51 mg/dL (95% CI 8.51 to 30.51; 3 studies; 333 participants; moderate-quality evidence). Over the long term (more than six months) total cholesterol decreased by a mean of 17.57 mg/dL (95% CI 14.95 to 20.19; 2 studies; 127 participants; high-quality evidence). Included studies did not report usable data for health outcome indications, adverse effects or costs/resource use, so we could not pool these outcomes. We assessed each included study for bias using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. In general, the risk of bias assessment revealed a low risk of selection bias, attrition bias, and reporting bias. There was unclear risk of bias relating to blinding for most studies.
AUTHORS' CONCLUSIONS:
The evidence in our review demonstrates that intensification of patient care interventions improves short- and long-term medication adherence, as well as total cholesterol and LDL-cholesterol levels. Healthcare systems which can implement team-based intensification of patient care interventions may be successful in improving patient adherence rates to lipid-lowering medicines.
