Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions.
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ABSTRACT: Purpose of review
Traditional methods to assess antiretroviral adherence, such as self-report, pill counts, and pharmacy refill data, may be inaccurate in determining actual pill-taking to both antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP). HIV viral loads serve as surrogates of adherence on ART, but loss of virologic control may occur well after decreases in adherence and viral loads are not relevant to PrEP.Recent findings
Pharmacologic measures of adherence, electronic adherence monitors, and ingestible electronic pills all serve as more objective metrics of adherence, surpassing self-report in predicting outcomes. Pharmacologic metrics can identify either recent adherence or cumulative adherence. Recent dosing measures include antiretroviral levels in plasma or urine, as well as emtricitabine-triphosphate in dried blood spots (DBS) for those on tenofovir-emtricitabine-based therapy. A urine tenofovir test has recently been developed into a point-of-care test for bedside adherence monitoring. Cumulative adherence metrics assess adherence over weeks to months and include measurement of tenofovir-diphosphate in peripheral blood mononuclear cells or DBS, as well as ART levels in hair. Electronic adherence monitors and ingestible electronic pills can track pill bottle openings or medication ingestion, respectively. New and objective approaches in adherence monitoring can be used to detect nonadherence prior to loss of prevention efficacy or virologic control with PrEP or ART, respectively.
SUBMITTER: Spinelli MA
PROVIDER: S-EPMC7363551 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundDespite effective therapies for many conditions, patients find it difficult to adhere to prescribed treatments. Technology-mediated interventions (TMIs) are increasingly being used with the hope of improving adherence.ObjectiveTo assess the effects of TMI, intended to enhance patient adherence to prescribed medications, on both medication adherence and clinical outcomes.MethodsA secondary in-depth analysis was conducted of the subset of studies that utilized technology in at least one component of the intervention from an updated Cochrane review on all interventions for enhancing medication adherence. We included studies that clearly described an information and communication technology or medical device as the sole or major component of the adherence intervention.ResultsThirty-eight studies were eligible for in-depth review. Only seven had a low risk of bias for study design features, primary adherence, and clinical outcomes. Eighteen studies used a TMI for education and/or counseling, 11 studies used a TMI for self-monitoring and/or feedback, and nine studies used electronic reminders. Studies used a variety of TMIs, with telephone the most common technology in use. Studies targeted a wide distribution of diseases and used a variety of adherence and clinical outcome measures. A minority targeted children and adolescents. Fourteen studies reported significant effects in both adherence and clinical outcome measures.ConclusionsThis review provides evidence for the inconsistent effectiveness of TMI for medication adherence and clinical outcomes. These results must be interpreted with caution due to a lack of high-quality studies.
| S-EPMC7659214 | biostudies-literature
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| S-EPMC5502075 | biostudies-literature
Project description:BackgroundLipid-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.ObjectivesTo assess the effects of interventions aimed at improving adherence to lipid-lowering drugs, focusing on measures of adherence and clinical outcomes.Search methodsWe 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 criteriaWe 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 analysisThree 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 resultsFor 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' conclusionsThe 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.
| S-EPMC6464006 | biostudies-literature
Project description:BackgroundOver the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA), which have led to a reduction in disease flares and the risk of re-fracture in osteoporosis, and the slowing of disease progression in RA. However, medication adherence remains suboptimal, as treatment regimens can be complex and difficult to continue long term. Many trials have been conducted to improve adherence to medication. Core domains, which are the outcomes of most relevance to patients and clinicians, are a pivotal component of any trial. These core domains should be measured consistently, so that all relevant trials can be combined in systematic reviews and meta-analyses to reach conclusions that are more valid. Failure to do this severely limits the potential for trial-based evidence to inform decisions on how to support medication adherence. The Outcome Measures in Rheumatology (OMERACT) - Interventions for Medication Adherence study by the OMERACT-Adherence Group aims to develop a core domain set for interventions that aim to support medication adherence in rheumatology.Methods/designThis OMERACT-Adherence study has five phases: (1) a systematic review to identify outcome domains that have been reported in interventions focused on supporting medication adherence in rheumatology; (2) semi-structured stakeholder interviews with patients and caregivers to determine their views on the core domains; (3) focus groups using the nominal group technique with patients and caregivers to identify and rank domains that are relevant to them, including the reasons for their choices; (4) an international three-round modified Delphi survey involving patients with diverse rheumatic conditions, caregivers, health professionals, researchers and other stakeholders to develop a preliminary core domain set; and (5) a stakeholder workshop with OMERACT members to review, vote on and reach a consensus on the core domain set for interventions to support medication adherence in rheumatology.DiscussionEstablishing a core domain set to be reported in all intervention studies undertaken to support patients with medication adherence will enhance the relevance and the impact of these results and improve the lives of people with rheumatic conditions.
| S-EPMC5870260 | biostudies-literature
Project description:Patients with heart failure (HF) take many medications to manage their HF and comorbidities, and 20-50% experience depression. Depressed individuals with more complex medication regimens may be at greater risk for poor adherence. The aim of this study was to assess depressive symptoms as a moderator of the relationship between medication regimen complexity and medication adherence in an observational study of patients with HF. In hierarchical linear regression with the final sample of 299, the interaction of medication regimen complexity and depressive symptoms predicted medication adherence, p < .05. For individuals with higher levels of depressive symptoms [1 standard deviation (SD) above the mean], more regimen complexity was associated with lower adherence. For individuals with low (1 SD below the mean) or average levels of depressive symptoms, regimen complexity was unrelated to medication adherence. Care management strategies, including pillboxes and caregiver involvement, may be valuable in HF patients with depression.
| S-EPMC5873320 | biostudies-literature
Project description:BackgroundMedication adherence is important in managing the progression of chronic diseases. A promising approach to reduce cognitive burden when measuring medication adherence lies in the use of computer-adaptive tests (CATs) or in the development of shorter patient-reported outcome measures (PROMs). However, the lack of an item bank currently hampers this progress.ObjectiveWe aim to develop an item bank to measure general medication adherence.MethodsUsing the preferred reporting items for systematic review and meta-analysis (PRISMA), articles published before October 2019 were retrieved from PubMed, Embase, CINAHL, the Cochrane Library, and Web of Science. Items from existing PROMs were classified and selected ("binned" and "winnowed") according to standards published by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cooperative Group.ResultsA total of 126 unique PROMs were identified from 213 studies in 48 countries. Items from the literature review (47 PROMs with 579 items for which permission has been obtained) underwent binning and winnowing. This resulted in 421 candidate items (77 extent of adherence and 344 reasons for adherence).ConclusionsWe developed an item bank for measuring general medication adherence using items from validated PROMs. This will allow researchers to create new PROMs from selected items and provide the foundation to develop CATs.
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Project description:PurposeTo systematically summarize evidence from multiple systematic reviews (SRs) examining interventions addressing medication nonadherence and to discern differences in effectiveness by intervention, patient, and study characteristics.SummaryMEDLINE, the Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects were searched for papers published from January 2004 to February 2017. English-language SRs examining benefits of medication adherence interventions were eligible. Inclusion was limited to adult patients prescribed medication for 1 of the following disease conditions: diabetes and prediabetes, heart conditions, hypertension and prehypertension, stroke, and cognitive impairment. Non-disease-specific SRs that considered medication adherence interventions for older adults, adults with chronic illness, and adults with known medication adherence problems were also included. Two researchers independently screened titles, abstracts, and full-text articles. They then extracted key variables from eligible SRs, reconciling discrepancies via discussion. A MeaSurement Tool to Assess systematic Reviews (AMSTAR) was used to assess SRs; those with scores below 8 were excluded. Conclusions regarding intervention effectiveness were extracted. Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methodology was applied to assess evidence quality.ResultsOf 390 SRs, 25 met the inclusion criteria and assessed adherence as a primary outcome. Intervention types most consistently found to be effective were dose simplification, patient education, electronic reminders to patients, and reduced patient cost sharing or incentives. Of 50 conclusions drawn by the SRs, the underlying evidence was low or very low quality for 45 SRs.ConclusionDespite an abundance of primary studies and despite only examining high-quality SRs, the vast majority of primary studies supporting SR authors' conclusions were of low or very low quality. Nonetheless, health system leaders seeking to improve medication adherence should prioritize interventions that have been studied and found to be effective at improving patient adherence, including dose simplification, education, reminders, and financial incentives.
| S-EPMC6946938 | biostudies-literature
Project description:BackgroundSub-optimal medication adherence in pregnant women with chronic disease and pregnancy-related indications has the potential to adversely affect maternal and perinatal outcomes. Adherence to appropriate medications is advocated during and when planning pregnancy to reduce risk of adverse perinatal outcomes relating to chronic disease and pregnancy-related indications. We aimed to systematically identify effective interventions to promote medication adherence in women who are pregnant or planning to conceive and impact on perinatal, maternal disease-related and adherence outcomes.MethodsSix bibliographic databases and two trial registries were searched from inception to 28th April 2022. We included quantitative studies evaluating medication adherence interventions in pregnant women and women planning pregnancy. Two reviewers selected studies and extracted data on study characteristics, outcomes, effectiveness, intervention description (TIDieR) and risk of bias (EPOC). Narrative synthesis was performed due to study population, intervention and outcome heterogeneity.ResultsOf 5614 citations, 13 were included. Five were RCTs, and eight non-randomised comparative studies. Participants had asthma (n = 2), HIV (n = 6), inflammatory bowel disease (IBD; n = 2), diabetes (n = 2) and risk of pre-eclampsia (n = 1). Interventions included education +/- counselling, financial incentives, text messaging, action plans, structured discussion and psychosocial support. One RCT found an effect of the tested intervention on self-reported antiretroviral adherence but not objective adherence. Clinical outcomes were not evaluated. Seven non-randomised comparative studies found an association between the tested intervention and at least one outcome of interest: four found an association between receiving the intervention and both improved clinical or perinatal outcomes and adherence in women with IBD, gestational diabetes mellitus (GDM), and asthma. One study in women with IBD reported an association between receiving the intervention and maternal outcomes but not for self-reported adherence. Two studies measured only adherence outcomes and reported an association between receiving the intervention and self-reported and/or objective adherence in women with HIV and risk of pre-eclampsia. All studies had high or unclear risk of bias. Intervention reporting was adequate for replication in two studies according to the TIDieR checklist.ConclusionsThere is a need for high-quality RCTs reporting replicable interventions to evaluate medication adherence interventions in pregnant women and those planning pregnancy. These should assess both clinical and adherence outcomes.
| S-EPMC9979410 | biostudies-literature
Project description:ObjectiveDescribe a novel approach to comprehensively summarize medication adherence.Data sources/study settingKaiser Permanente Northern California Diabetes Registry (n approximately 220,000)Study designIn a new prescription cohort design (27,329 subjects prescribed new medications), we used pharmacy utilization data to estimate adherence during 24 months follow-up. Proportion of time without sufficient medications (medication gaps) was estimated using a novel measure (New Prescription Medication Gaps [NPMG]) and compared with a traditional measure of adherence.Data collection/extraction methodsData derived from electronic medical records and survey responses.Principal findingsTwenty-two percent of patients did not become ongoing users (had zero or only one dispensing of the new prescription). The proportion of newly prescribed patients that never became ongoing users was eightfold greater than the proportion who maintained ongoing use, but with inadequate adherence. Four percent of those with at least two dispensings discontinued therapy during the 24 months follow-up. NPMG was significantly associated with high out-of-pocket costs, self-reported adherence, and clinical response to therapy.ConclusionsNPMG is a valid adherence measure. Findings also suggest a larger burden of inadequate adherence than previously thought. Public health efforts have traditionally focused on improving adherence in ongoing users; clearly more attention is needed to address nonpersistence in the very first stages after a new medication is prescribed.
| S-EPMC2754552 | biostudies-literature
Project description:BACKGROUND:Subclinical cognitive impairment is prevalent in heart failure (HF); however, its role in important clinical outcomes, such as HF treatment adherence, is unclear. Given the complex polypharmacy in HF treatment, cognitive deficits may be important in predicting medication management. Thus, the objective of the current study was to examine the impact of cognitive function on medication adherence among community-dwelling patients with HF using objective assessments. METHODS AND RESULTS:A prospective observational cohort design of 309 community-dwelling patients with HF (59.7% male, 68.7±9.7 years) and no history of dementia or neurological disease. Cognition was assessed using a neuropsychological battery at baseline. Medication adherence was objectively measured for 21 days using an electronic pillbox. Regression analyses tested whether attention, executive function, or memory predicted 21-day medication adherence. In unadjusted analyses, lower scores on all 3 cognitive domains predicted poorer medication adherence (?=0.52-85; P=0.001-0.009). After adjusting for demographic, clinical, and psychosocial variables, memory continued to predict medication adherence (?=0.51; P=0.008), whereas executive function (?=0.24; P=0.075) and attention were no longer a predictor (?=0.34; P=0.131). CONCLUSIONS:Poorer cognitive function, especially in regard to memory, predicted reduced medication adherence among patients with HF and no history of dementia. This effect remained after adjustment for factors known to predict adherence, such as depressed mood, social support, and disease severity level. Future studies should examine the link from cognitive impairment and medication nonadherence to clinical outcomes (eg, hospitalization and mortality). CLINICAL TRIAL REGISTRATION:URL: http://www.clinicaltrials.gov. Unique identifier: NCT01461629.
| S-EPMC5131517 | biostudies-literature