Measuring adherence to antiretroviral treatment in resource-poor settings: The clinical validity of key indicators

<p>Abstract</p> <p>Background</p> <p>Access to antiretroviral therapy has dramatically expanded in Africa in recent years, but there are no validated approaches to measure treatment adherence in these settings.</p> <p>Methods</p> <p>In 16 health facilities, we observed a retrospective cohort of patients initiating antiretroviral therapy. We constructed eight indicators of adherence and visit attendance during the first 18 months of treatment from data in clinic and pharmacy records and attendance logs. We measured the correlation among these measures and assessed how well each predicted changes in weight and CD4 count.</p> <p>Results</p> <p>We followed 488 patients; 63.5% had 100% coverage of medicines during follow-up; 2.7% experienced a 30-day gap in treatment; 72.6% self-reported perfect adherence in all clinic visits; and 19.9% missed multiple clinic visits. After six months of treatment, mean weight gain was 3.9 kg and mean increase in CD4 count was 138.1 cells/mm3.</p> <p>Dispensing-based adherence, self-reported adherence, and consistent visit attendance were highly correlated. The first two types of adherence measure predicted gains in weight and CD4 count; consistent visit attendance was associated only with weight gain.</p> <p>Conclusions</p> <p>This study demonstrates that routine data in African health facilities can be used to monitor antiretroviral adherence at the patient and system level.</p

Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p&lt;0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (&lt;1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (&lt;1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline

Éthologie humaine et thérapie familiale

Angel Pierre, Miermont Jacques, Schlee Marsha. Éthologie humaine et thérapie familiale. In: Bulletin de psychologie, tome 38 n°370, 1985. Psychologie clinique VIII. pp. 437-441

Medicare Beneficiaries and Free Prescription Drug Samples: A National Survey

BACKGROUND: New policies regulating physician/pharmaceutical company relationships propose to eliminate access to free prescription drug samples. Little is known about the prevalence of patient activity in requesting or receiving free prescription drug samples, or the characteristics of patients who access drug samples. OBJECTIVE: To determine the prevalence of free sample access and to examine demographic, clinical, and insurance characteristics of Medicare beneficiaries who access free samples. DESIGN: Cross-sectional study. PARTICIPANTS: A national sample of 13,847 Medicare beneficiaries participating in the fall 2004 Medicare Current Beneficiary Survey. MEASUREMENTS AND MAIN RESULTS: Prevalence of free prescription drug sample access (self-reported request for or receipt of free drug samples) and the demographic, clinical, and insurance characteristics of Medicare beneficiaries who accessed drug samples. Overall, 48.3% (95% confidence of interval [CI]: 46.6%, 49.9%) of Medicare beneficiaries reported accessing free drug samples. Access was higher among beneficiaries reporting cost-related medication nonadherence compared to those without (77.7% (95% CI: 74.5%, 80.6%) vs 43.0% (95% CI: 41.4%, 44.7%)). Multivariable analysis revealed cost-related medication nonadherence (CRN) to have the strongest relationship with accessing drug samples (adjusted odds ratio [AOR] 4.43 [95% CI: 3.64, 5.39]). Compared to beneficiaries with generous drug benefits from Medicaid, beneficiaries who lacked prescription drug benefits were more likely to access drug samples (AOR 2.42 [95% CI: 2.06, 2.85]). Beneficiaries with drug coverage from employer-sponsored plans or partial coverage (Medicare HMO, self-purchased Medicare supplement, or state-sponsored low-income plans) were also more likely to access drug samples (AOR 2.02, 1.74, respectively). Having 2-3 or \u3e or = 4 comorbidities (vs 0-1 comorbidities) also increased the likelihood of accessing drug samples (AOR 1.60 (95% CI: 1.44, 1.79) and 2.00 (95% CI: 1.74, 2.29). CONCLUSIONS: Accessing free prescription drug samples is prevalent among many categories of beneficiaries, especially among individuals with cost-related medication nonadherence and poor health status. Policies restricting or prohibiting drug sample distribution may adversely impact access to medications among patients in high-risk groups

Cost-Related Medication Nonadherence Among Elderly and Disabled Medicare Beneficiaries

Background Prior to implementation of the Medicare drug benefit, we estimated the prevalence of cost-related medication nonadherence (CRN) among Medicare enrollees, including elderly and nonelderly disabled beneficiaries. Methods In the fall of 2004, detailed measures of CRN (skipping or reducing doses or not filling prescriptions because of cost) were added to the Medicare Current Beneficiary Survey. We examined the prevalence of CRN nationally and by Medicare eligibility subgroups (elderly vs nonelderly disabled beneficiaries), drug coverage status, socioeconomic status, self-rated health, and number of chronic medical conditions. Results In a national sample of 13 835 noninstitutionalized Medicare enrollees, 29% of the disabled and 13% of the elderly beneficiaries reported CRN; those in fair to poor health with multiple comorbidities and without coverage were most at risk. Among the disabled enrollees with 4 or more morbidities, 52% (95% confidence interval [CI], 43.3%-60.3%) without drug coverage skipped prescriptions or doses compared with 26% (95% CI, 17.7%-34.8%) with Medicaid drug coverage. Those with partial drug coverage through Medigap policies or Medicare health maintenance organizations reported intermediate rates of CRN. The adjusted odds ratio of CRN among disabled enrollees in poor (vs good) health was 3.9 (95% CI, 1.7-9.2), whereas for those with 4 or more (vs <4) comorbidities, the odds ratio of CRN was 2.7 (95% CI, 1.7-4.1). Conclusions One year before Medicare Part D implementation, Medicare beneficiaries reported high rates of CRN. Rates are highest among nonelderly disabled beneficiaries, but among both elderly and disabled beneficiaries, CRN is exacerbated by poor health, multiple morbidities, and limited drug coverage. Given the high cost sharing under Part D, it is important to closely monitor CRN in high-risk subgroups

Depression and Cost-Related Medication Nonadherence in Medicare Beneficiaries

Context Treatment for depression can be expensive and depression can affect the use of other medical services, yet there is little information on how depression affects the prevalence of cost-related medication nonadherence (CRN) in elderly patients and patients with disabilities. Objective To quantify the presence of CRN in depressed and nondepressed elderly Medicare beneficiaries and nonelderly Medicare beneficiaries with disabilities prior to the implementation of the Medicare Drug Benefit. Design and Setting 2004 Medicare Current Beneficiary Survey. Participants Depressed and nondepressed elderly Medicare beneficiaries and beneficiaries with disabilities. Main Outcome Measures Cost-related medication nonadherence included taking smaller doses or skipping doses of a prescription to make it last longer, or failing to fill a prescription because of cost, controlling for health insurance status, comorbid conditions, age, race, sex, and functional status. Results In a nationally representative sample of 13 835 noninstitutionalized elderly Medicare enrollees and Medicare enrollees with disabilities, 44% of beneficiaries with disabilities and 13% of elderly beneficiaries reported being depressed during the previous year. Among enrollees with disabilities reporting depressive symptoms, 38% experienced CRN compared with 22% of enrollees with disabilities who did not report depressive symptoms. Among elderly enrollees who reported depressive symptoms, 19% experienced CRN, compared with 12% of elderly enrollees who did not report such symptoms. In adjusted analyses, depressive symptoms remained a significant predictor of CRN in both groups (persons with disabilities: odds ratio, 1.7; 95% confidence interval, 1.3-2.3; elderly persons: odds ratio, 1.4; 95% confidence interval, 1.1-1.7). Conclusions Depressive symptoms were associated with CRN in elderly Medicare enrollees and Medicare enrollees with disabilities. Providers should elicit information on economic barriers that might interfere with treatment of Medicare beneficiaries with depression

Reliability of new measures of cost-related medication nonadherence

BACKGROUND: Although several national studies have attempted to measure medication nonadherence due to cost in cross-sectional studies of the elderly and disabled, little information exists on the psychometric properties of these measures over time. OBJECTIVES: Examine the test-retest reliability of several recently published measures of cost-related medication nonadherence, among elderly community. METHODS: We developed a questionnaire and tested the reliability of measures of cost-related medication nonadherence and general cost-reduction strategies in a sample of 185 elderly in eastern Massachusetts surveyed twice (1-2 months apart). General and medicine-specific cost-related nonadherence measures included: failure to fill or delayed refilling of a prescription due to its cost, skipping doses, or taking smaller doses to make a medicine last longer. We also tested the reliability of reported drug cost-reduction strategies, such as: using generic drugs; purchasing prescriptions via mail/internet or from outside the United States; receiving prescription samples from a doctor; and spending less on food, heat, or other basic needs to afford medicines. We used the McNemar test, a matched pair chi analysis, and Kappa statistics to examine the association of responses within patients between identical items asked at 2 points in time. RESULTS: Kappa statistics for test-retest reliability ranged from 0.6 to 0.9 for all but one measure of cost-related nonadherence, and McNemar test statistics indicated no systematic change in the measures over time. CONCLUSIONS: The estimated test-retest reliability of the measures of cost-related medication nonadherence were generally high. The measures have been integrated into the nationally representative Medicare Current Beneficiary Survey (MCBS), an ongoing national panel survey of Medicare beneficiaries, which will allow researchers and policymakers to identify changes in cost-related nonadherence among disabled and elderly Medicare beneficiaries

Cost-related medication nonadherence among elderly and disabled medicare beneficiaries: a national survey 1 year before the medicare drug benefit

BACKGROUND: Prior to implementation of the Medicare drug benefit, we estimated the prevalence of cost-related medication nonadherence (CRN) among Medicare enrollees, including elderly and nonelderly disabled beneficiaries. METHODS: In the fall of 2004, detailed measures of CRN (skipping or reducing doses or not filling prescriptions because of cost) were added to the Medicare Current Beneficiary Survey. We examined the prevalence of CRN nationally and by Medicare eligibility subgroups (elderly vs nonelderly disabled beneficiaries), drug coverage status, socioeconomic status, self-rated health, and number of chronic medical conditions. RESULTS: In a national sample of 13 835 noninstitutionalized Medicare enrollees, 29% of the disabled and 13% of the elderly beneficiaries reported CRN; those in fair to poor health with multiple comorbidities and without coverage were most at risk. Among the disabled enrollees with 4 or more morbidities, 52% (95% confidence interval [CI], 43.3%-60.3%) without drug coverage skipped prescriptions or doses compared with 26% (95% CI, 17.7%-34.8%) with Medicaid drug coverage. Those with partial drug coverage through Medigap policies or Medicare health maintenance organizations reported intermediate rates of CRN. The adjusted odds ratio of CRN among disabled enrollees in poor (vs good) health was 3.9 (95% CI, 1.7-9.2), whereas for those with 4 or more (vs \u3c4) comorbidities, the odds ratio of CRN was 2.7 (95% CI, 1.7-4.1). CONCLUSIONS: One year before Medicare Part D implementation, Medicare beneficiaries reported high rates of CRN. Rates are highest among nonelderly disabled beneficiaries, but among both elderly and disabled beneficiaries, CRN is exacerbated by poor health, multiple morbidities, and limited drug coverage. Given the high cost sharing under Part D, it is important to closely monitor CRN in high-risk subgroups

Depression and cost-related medication nonadherence in Medicare beneficiaries

CONTEXT: Treatment for depression can be expensive and depression can affect the use of other medical services, yet there is little information on how depression affects the prevalence of cost-related medication nonadherence (CRN) in elderly patients and patients with disabilities. OBJECTIVE: To quantify the presence of CRN in depressed and nondepressed elderly Medicare beneficiaries and nonelderly Medicare beneficiaries with disabilities prior to the implementation of the Medicare Drug Benefit. DESIGN AND SETTING: 2004 Medicare Current Beneficiary Survey. PARTICIPANTS: Depressed and nondepressed elderly Medicare beneficiaries and beneficiaries with disabilities. MAIN OUTCOME MEASURES: Cost-related medication nonadherence included taking smaller doses or skipping doses of a prescription to make it last longer, or failing to fill a prescription because of cost, controlling for health insurance status, comorbid conditions, age, race, sex, and functional status. RESULTS: In a nationally representative sample of 13 835 noninstitutionalized elderly Medicare enrollees and Medicare enrollees with disabilities, 44% of beneficiaries with disabilities and 13% of elderly beneficiaries reported being depressed during the previous year. Among enrollees with disabilities reporting depressive symptoms, 38% experienced CRN compared with 22% of enrollees with disabilities who did not report depressive symptoms. Among elderly enrollees who reported depressive symptoms, 19% experienced CRN, compared with 12% of elderly enrollees who did not report such symptoms. In adjusted analyses, depressive symptoms remained a significant predictor of CRN in both groups (persons with disabilities: odds ratio, 1.7; 95% confidence interval, 1.3-2.3; elderly persons: odds ratio, 1.4; 95% confidence interval, 1.1-1.7). CONCLUSIONS: Depressive symptoms were associated with CRN in elderly Medicare enrollees and Medicare enrollees with disabilities. Providers should elicit information on economic barriers that might interfere with treatment of Medicare beneficiaries with depression