Dataset Information

Association of Medication Adherence With Health Outcomes in the ISCHEMIA Trial.

ABSTRACT:

Background

The ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial randomized participants with chronic coronary disease (CCD) to guideline-directed medical therapy with or without angiography and revascularization. The study examined the association of nonadherence with health status outcomes.

Objectives

The study sought to compare 12-month health status outcomes of adherent and nonadherent participants with CCD with an a priori hypothesis that nonadherent patients would have better health status if randomized to invasive management.

Methods

Self-reported medication-taking behavior was assessed at randomization with a modified 4-item Morisky-Green-Levine Adherence Scale, and participants were classified as adherent or nonadherent. Twelve-month health status was assessed with the 7-item Seattle Angina Questionnaire (SAQ-7) summary score (SS), which ranges from 0 to 100 (higher score = better). The association of adherence with outcomes was evaluated using Bayesian proportional odds models, including an interaction by study arm (conservative vs invasive).

Results

Among 4,480 randomized participants, 1,245 (27.8%) were nonadherent at baseline. Nonadherent participants had worse baseline SAQ-7 SS in both conservative (72.9 ± 19.3 vs 75.6 ± 18.4) and invasive (71.0 ± 19.8 vs 74.2 ± 18.7) arms. In adjusted analyses, adherence was associated with higher 12-month SAQ-7 SS in both treatment groups (mean difference in SAQ-7 SS with conservative treatment = 1.6 [95% credible interval: 0.3-2.9] vs with invasive management = 1.9 [95% credible interval: 0.8-3.1]), with no interaction by treatment.

Conclusions

More than 1 in 4 participants reported medication nonadherence, which was associated with worse health status in both conservative and invasive treatment strategies at baseline and 12 months. Strategies to improve medication adherence are needed to improve health status outcomes in CCD, regardless of treatment strategy. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).

SUBMITTER: Garcia RA

PROVIDER: S-EPMC10548342 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Association of Medication Adherence With Health Outcomes in the ISCHEMIA Trial.

Garcia R Angel RA Spertus John A JA Benton Mary C MC Jones Philip G PG Mark Daniel B DB Newman Jonathan D JD Bangalore Sripal S Boden William E WE Stone Gregg W GW Reynolds Harmony R HR Hochman Judith S JS Maron David J DJ

Journal of the American College of Cardiology 20220801 8

<h4>Background</h4>The ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial randomized participants with chronic coronary disease (CCD) to guideline-directed medical therapy with or without angiography and revascularization. The study examined the association of nonadherence with health status outcomes.<h4>Objectives</h4>The study sought to compare 12-month health status outcomes of adherent and nonadherent participants with CCD with an a ...[more]

PMID: 35981820

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Project description:IntroductionThe exact pathway linking health literacy, self-efficacy, medication adherence, and glycemic control for type 2 diabetes remains unclear. Understanding the relationship between patient factors, medication adherence, and lower glycated hemoglobin (HbA1c) may help patients better manage their disease. This study examined the association of health literacy and medication self-efficacy with self-reported diabetes medication adherence, and the association of health literacy, medication self-efficacy, and self-reported diabetes medication adherence with HbA1c of patients with type 2 diabetes.MethodsThis cross-sectional study utilized a face-to-face questionnaire at two family medicine clinics in a Midwestern state among 174 patients; subjects enrolled were at least 20 years old with diagnosed type 2 diabetes, prescribed at least one oral diabetes medicine, and understood English. Questionnaires were administered to assess the participants': health literacy, using the Newest Vital Sign six-item questionnaire (NVS); self-efficacy for medication use, using the 13-item Self-Efficacy for Appropriate Medication Use Scale; and self-report medication adherence, using the eight-item Morisky Medication Adherence Scale. HbA1c values were obtained from participants' electronic medical records. Multiple linear regressions were used to explore the association of health literacy and medication self-efficacy with both medication adherence and HbA1c level after controlling for all other covariates.ResultsSelf-reported health status (β = 0.17, p = 0.015) and medication self-efficacy (β = 0.53, p < 0.001) were positively associated with diabetes medication adherence. Health literacy was neither associated with diabetes medication adherence (β = -0.04, p = 0.586) nor HbA1c (β = -0.06, p = 0.542). Lower diabetes medication adherence (β = -0.26, p = 0.008) and higher number of prescribed medications (β = 0.28, p = 0.009) were correlated with higher HbA1c.ConclusionHealth literacy, as measured by the NVS, does not correlate with medication adherence or glycemic control among patients with type 2 diabetes. Interventions to improve patients' self-efficacy of medication use may improve diabetes medication adherence.

Project description:BackgroundThe treatment of many chronic illnesses involves long-term pharmaceutical therapy, but it is an ongoing challenge to find effective ways to improve medication adherence to promote good health outcomes. Cardioprotective medications can prevent the enlargement of harmful clots, cardiovascular symptoms, and poor therapeutic outcomes, such as uncontrolled high blood pressure and hyperlipidemia, for patients with coronary heart disease. Poor adherence to cardioprotective medications, however, has been reported as a global health concern among patients with coronary heart disease, and it is particularly a concern in China.ObjectiveThis study aimed to evaluate the efficacy of a mobile health (mHealth) intervention using 2 mobile apps to improve medication adherence and health outcomes.MethodsA randomized, placebo-controlled, 2-arm parallel study was conducted in a major university-affiliated medical center located in Chengdu, China. Participants were recruited by flyers and health care provider referrals. Each participant was observed for 90 days, including a 60-day period of mHealth intervention and a 30-day period of nonintervention follow-up. The study coordinator used WeChat and Message Express to send educational materials and reminders to take medication, respectively. Participants used WeChat to receive both the educational materials and reminders. Participants in the control group only received educational materials. This study received ethics approval from the Duke Health Institutional Review Board (Pro00073395) on May 5, 2018, and was approved by West China Hospital (20170331180037). Recruitment began on May 20, 2018. The pilot phase of this study was registered on June 8, 2016, and the current, larger-scale study was retrospectively registered on January 11, 2021 (ClinicalTrials.gov).ResultsWe recruited 230 patients with coronary heart disease. Of these patients, 196 completed the baseline survey and received the intervention. The majority of participants were married (181/196, 92.4%), male (157/196, 80.1%), and lived in urban China (161/196, 82.1%). Participants' average age was 61 years, and half were retired (103/191, 53.9%). More than half the participants (121/196, 61.7%) were prescribed at least 5 medications. The mean decrease in medication nonadherence score was statistically significant at both 60 days (t179=2.04, P=.04) and 90 days (t155=3.48, P<.001). Systolic blood pressure and diastolic blood pressure decreased in the experimental group but increased in the control group. The mean decrease in diastolic blood pressure was statistically significant at both 60 days (t160=2.07, P=.04) and 90 days (t164=2.21, P=.03). The mean decrease in systolic blood pressure was significantly different in the groups at 90 days (t165=3.12, P=.002).ConclusionsThe proposed mHealth intervention can improve medication adherence and health outcomes, including systolic blood pressure and diastolic blood pressure.Trial registrationClinicalTrials.gov NCT02793830; https://clinicaltrials.gov/ct2/show/NCT02793830 and ClinicalTrials.gov NCT04703439; https://clinicaltrials.gov/ct2/show/NCT04703439.

Project description:Background Medication nonadherence contributes to poor health outcomes but remains challenging to identify. This study assessed the association between self-rated adherence and systolic blood pressure, low-density lipoprotein cholesterol levels, cardiovascular events, and all-cause mortality in SPRINT (Systolic Blood Pressure Intervention Trial). Methods and Results A total of 9361 patients randomized to 2 systolic blood pressure target groups, <120 mm Hg (intensive) and <140 mm Hg (standard), self-rated their medication adherence at each visit by marking a scale, ranging from 0% to 100%. Lower and high adherence were defined as scores ≤80% and >80%, respectively. Linear mixed effect regression models and Cox proportional hazard models were used to evaluate the association between self-rated adherence and systolic blood pressure and low-density lipoprotein cholesterol and cardiovascular events and all-cause mortality, respectively. A total of 9278 participants (mean age 68±9.4 years, 35.6% female) had repeated self-rated adherence measurements available, with a mean of 15±4 measurements per participant over 3.8 years follow-up. Of these, 2694 participants (29.0%) had ≥1 adherence measurements ≤80%. Compared with high-adherent patients, patients with lower adherence had significantly higher estimated on-treatment systolic blood pressure at 2-year follow-up: 128.7 (95% CI, 127.6-129.9) versus 120.0 (95% CI, 119.7-120.2) mm Hg in the intensive arm; and 139.8 (95% CI 138.4-141.1) versus 135.0 (95% CI 134.7-135.2) in the standard arm. Moreover, lower adherence was associated with an estimated 11 mg/dL higher low-density lipoprotein cholesterol level, more cardiovascular events (hazard ratio [HR], 1.69 [95% CI, 1.20-2.39]), and higher all-cause mortality (HR, 1.63 [95% CI, 1.16-2.31]). Conclusions Self-rated adherence allows identification of lower medication adherence and correlates with blood pressure control, low-density lipoprotein cholesterol levels, and adverse outcomes.

Project description:Background: Few studies have investigated the association between medication literacy and medication adherence as well as the influence of medication literacy on medication adherence in hypertensive patients. Thus, the goal of the present study was to determine the association between medication literacy and medication adherence in hypertensive patients. Methods: A cross-sectional survey was conducted between August 2016 and December 2016. Self-administered questionnaires were completed, including a self-developed and structured socio-demographic questionnaire; a self-developed, validated, and self-reported Medication Literacy Scale for Hypertensive Patients (C-MLSHP) used for medication literacy measurement; and the Chinese Version of the Morisky Medication Adherence Scale-8 (C-MMAS-8), an eight-item validated, self-report scale for adherence measurement with a total score range of 0-8. A cut-off of 6 was applied to differentiate adherence levels, including patients with an MMAS score <6 (low adherence), MMAS score = 8 (high adherence), and MMAS score ?6 and <8 (moderate adherence). In this study, hypertensive patients' medication literacy levels and adherence to antihypertensive agents were identified. Pearson correlation analysis was carried out to identify the correlation between medication literacy and adherence. Binary logistic regression analysis was performed with medication adherence as the outcome variable in order to confirm factors associated with medication adherence. Results: A total of 420 hypertensive patients, including 198 women and 222 men with a mean age of 60.6 years (SD = 12.4), were recruited. The mean score of hypertensive patients on the medication literacy scale was 24.03 (SD = 5.13). The mean scores of the four dimensions of knowledge, attitude, skill, and behavior on the medication literacy scale of this study were 6.22 ± 2.22, 5.04 ± 1.16, 4.50 ± 2.21, and 8.27 ± 1.90, respectively. Regarding medication adherence, the mean score of the C-MMAS-8 in this study was 4.82 (SD = 2.11). A total of 63.6% of patients presented with low adherence, 29.5% presented with moderate adherence, and 7.6% presented with high adherence. The Pearson correlation results showed that medication literacy (r = 0.342, P < 0.01) as a whole variable and the three dimensions of knowledge (r = 0.284, P < 0.01), attitude (r = 0.405, P < 0.01), and behavior (r = 0.237, P < 0.01) were significantly associated with medication adherence. Binary logistic regression analysis indicated that annual income [OR 1.199 (95% CI: 1.011-1.421); P = 0.037] and two dimensions of attitude [OR 2.174 (95% CI: 1.748-2.706); P = 0.000] and behavior [OR 1.139 (95% CI: 1.002-1.294); P = 0.046] in medication literacy were found to be independent predictors of medication adherence. Individuals with better attitudes and behavior literacy in medication literacy were more likely to adhere to the use of antihypertensive agents. Those who had higher annual incomes were more likely to adhere to the use of antihypertensive agents. Conclusion: The levels of medication literacy and medication adherence of hypertensive patients are suboptimal and need to be improved in China. The level of medication literacy in patients with hypertension could affect their adherence to antihypertensive drugs. It was suggested that hypertensive patients' medication adherence could be improved and driven by increasing the medication literacy level, especially in the attitude and behavior domains. Pertinent strategies that are specific to several dimensions of medication literacy should be developed and implemented in order to promote full medication literacy among hypertensive patients, thus facilitating optimal adherence and blood pressure control.

Project description:ImportanceOpioid tapering has been associated with negative consequences, such as increased overdoses and mental health needs. Tapering could also alter use of health care services and worsen care of comorbid conditions through disruption in primary care.ObjectiveTo evaluate tapering of stable long-term opioid therapy (LTOT) and subsequent health care service use and chronic condition care.Design, setting, and participantsA retrospective cohort study was conducted from January 1, 2008, to December 31, 2019. Data analysis was performed from July 9, 2020, to December 9, 2022. Data from the Optum Labs Data Warehouse, which contains deidentified retrospective administrative claims data and linked electronic health record data for commercial and Medicare Advantage enrollees, were used. Adults aged 18 years or older prescribed stable doses of LTOT at 50 morphine milligram equivalents or more per day during a 12-month baseline period were included, including subcohorts with hypertension or diabetes.ExposuresOpioid tapering, with 15% or more relative reduction in mean daily dose in 6 overlapping periods during 6 months.Main outcomes and measuresEmergency department visits, hospitalizations, primary care and specialist visits, antihypertensive or antiglycemic medication adherence, and blood pressure and hemoglobin A1c levels during up to 12 months' follow-up. Covariates included sociodemographic characteristics, comorbidities, health care use, and chronic condition control.ResultsAmong 113 604 patients (60 764 [53.5%] women; mean [SD] age, 58.1 [11.8] years) prescribed LTOT, 41 207 had hypertension and 23 335 had diabetes; in all cohorts, approximately half were women, and half were aged 50 to 65 years. In the overall cohort, tapering was associated with more emergency department visits (adjusted incidence rate ratio [aIRR], 1.19; 95% CI, 1.16-1.21) and hospitalizations (aIRR, 1.16; 95% CI, 1.12-1.20), with similar magnitude associations in the hypertension and diabetes subcohorts. Tapering was associated with fewer primary care visits in the overall cohort (aIRR, 0.95; 95% CI, 0.94-0.96) and hypertension subcohort (aIRR, 0.98; 95% CI, 0.97-0.99). For the hypertension or diabetes subcohorts, tapering was associated with reduced medication adherence (hypertension: aIRR, 0.60; 95% CI, 0.59-0.62; diabetes: aIRR, 0.69; 95% CI, 0.67-0.71) and small increases in diastolic blood pressure and hemoglobin A1c level.Conclusions and relevanceIn this cohort study of patients prescribed LTOT, opioid tapering was associated with more emergency department visits and hospitalizations, fewer primary care visits, and reduced antihypertensive and antidiabetic medication adherence. These outcomes may represent unintended negative consequences of opioid tapering for policy makers and clinicians to consider.

Project description:BackgroundMedication adherence is crucial for improving clinical outcomes in the treatment of patients with cancer. The lack of adherence and adverse drug reactions can reduce the effectiveness of cancer therapy including the quality of life. The commonly used intervention methods for medication adherence continue to evolve, and the age of fifth-generation (5G) messaging has arrived.ObjectiveIn this study, we conducted a prospective, pilot randomized controlled trial to evaluate the effect of 5G messaging on medication adherence and clinical outcomes among patients with cancer in China.MethodsThe research population was patients with nonsmall cell lung cancer undergoing pemetrexed chemotherapy who require regular folic acid (FA) and vitamin B12 supplements. The intervention and control groups were assigned to 5G messaging and second-generation (2G) messaging, respectively. The patients' medication adherence and quality of life were assessed at baseline and 1-month and 3-month time points. Moreover, the chemotherapy-related hematologic or nonhematologic toxicities, as well as the serum levels of FA and vitamin B12, were measured.ResultsOf the 567 patients assessed for eligibility between January and May 2021, a total of 154 (27.2%) patients were included. Overall, 80 were randomized to the control group and 74 to the intervention group. The odds of adherence in the 5G messaging intervention group were significantly higher than the control group at the 1-month (62/69, 90% vs 56/74, 76%; adjusted odds ratio 2.67, 95% CI 1.02-7.71) and 3-month (50/60, 83% vs 48/64, 75%; adjusted odds ratio 2.36, 95% CI 1.00-5.23) time points. Correspondingly, the FA and vitamin B12 serum levels of patients in the 5G messaging group were higher than those of the control group. Regarding hematologic toxicities, only the incidence of leukopenia in the intervention group was lower than that in the control group (25/80, 31% in the control group vs 12/74, 16% in the intervention group; P=.04). There were no differences in nonhematologic toxicities and quality of life between the 2 groups.ConclusionsIn summary, we conclude that compared with conventional 2G text-based messaging, a 5G messaging intervention can better improve medication adherence and clinical outcome among patients with cancer.Trial registrationChinese Clinical Trial Registry ChiCTR2200058188; https://www.chictr.org.cn/showproj.html?proj=164489.

Dataset Information

Association of Medication Adherence With Health Outcomes in the ISCHEMIA Trial.

Background

Objectives

Methods

Results

Conclusions

Publications

Association of Medication Adherence With Health Outcomes in the ISCHEMIA Trial.

Similar Datasets

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