Medication Event Monitoring System Research Articles

Qualitative exploration of the modifiable factors for medication adherence among subsidised and self-paying patients in Malaysia

BackgroundNumerous studies have evaluated the related factors of medication adherence among patients with chronic disease. However, the factors influencing medication adherence and non-adherence among subsidised patients with chronic diseases—for whom medication costs may not be a constraint—remain unexplored. Thus, this study aims to identify and compare the potential factors that may influence subsidised and non-subsidised (i.e., self-paying) patients’ adherence to medication.MethodsSubsidised and self-paying patients were identified at public and private healthcare institutions in three states of Malaysia. Patients were then purposively selected for semi-structured, face-to-face interviews according to their medication adherence status (including adherent and non-adherent patients), which was measured using the Medication Event Monitoring System (MEMS). Adherence was defined as having 80% or more for the percentage of days in which the dose regimen was executed as prescribed. The interview was conducted from January to August 2016 and during the interviews, patients were asked to provide reasons for their medication adherence or non-adherence. The patient interviews were audio recorded and transcribed verbatim. Data were analysed using thematic analysis with NVivo 11 software.ResultsThirteen subsidised and 12 self-paying patients were interviewed. The themes found among subsidised and self-paying patients were similar. The factors that influenced adherence to medication include the ‘perceived importance of quality of life’ and ‘perceived benefit or value of the medications’. A unique factor reported by patients in this study included ‘perceived value of the money spent on medications’; more specifically, patients adhered to their medications because they valued the money spent to buy/receive the medications.ConclusionMedication adherence among subsidised and self-paying patients was influenced by many factors, including a unique factor relating to their perceptions of the value of money spent on medications.

Medication adherence and persistence in patients with autoimmune rheumatic diseases: a narrative review.

BackgroundSeveral drugs are available for the treatment of autoimmune rheumatic diseases; however, their effectiveness may be negatively influenced by inappropriate adherence. Low adherence and persistence rates have a significant impact on patient quality of life and are associated with health-related expenses.PurposeTo provide an up-to-date narrative review on treatment adherence and persistence rates, and discuss the factors that influence them, in patients with autoimmune rheumatic diseases.Materials and methodsWe searched the PubMed database for studies among patients with a diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), or psoriatic arthritis (PsA), published from January 2015 to February 2017. Only studies with a well-defined measurement of adherence/persistence and those that carried out an evaluation of the influencing factors were included.ResultsFifteen relevant studies that evaluated adherence and/or persistence were included. Adherence rates varied between 9.3% and 94%, and persistence rates between 23% and 80%. Most of the studies used one method to evaluate adherence or persistence (different questionnaire scores, proportion of days covered, and mean treatment duration). A high concordance was found between the adherence measurements of the Medication Event Monitoring System and Visual Analog Scale. Factors of economic, demographic, and clinical nature were only moderately linked to treatment adherence or persistence. However, patient-related factors – such as positive and increased beliefs in medication necessity, strong views of the chronic nature of the diseases, and increased knowledge of the disease – were related to better treatment adherence.ConclusionOwing to the heterogeneity of the study results, we consider that the use of more than one method to assess adherence/persistence should yield more comprehensive and accurate data about patient adherence behavior. Patient-related factors should be included and analyzed more often in adherence studies as the former may be modified to improve patient adherence.

Individualized texting for adherence building (iTAB) for methamphetamine users living with HIV: A pilot randomized clinical trial

BackgroundMethamphetamine (METH) use poses a barrier to antiretroviral therapy (ART) adherence. We evaluated the efficacy of the individualized texting for adherence building (iTAB) intervention among persons living with HIV (PLWH) who meet criteria for METH use disorder. We examined daily associations between ART adherence and text-reported METH use and depressed mood. MethodsWe conducted a single site, 2-arm, 6-week, pilot randomized clinical trial comparing a personalized, bidirectional, text messaging system (iTAB; n = 50) to an active control condition (n = 25). All participants received adherence psychoeducation and daily texts assessing METH use and depressed mood. The iTAB group received personalized daily ART reminder texts. ART adherence was monitored using Medication Event Monitoring System (MEMS) caps. ResultsResponse rates to daily ART reminder texts were high (79%), with good concordance between MEMS-derived and text-reported ART adherence (p < .001). Intervention groups did not differ in MEMS-derived ART adherence (68% iTAB, 70% active control; p = .68); however, participants in the iTAB group had fewer METH use days (median 14.4 iTAB, 22.0 active control; p = .05). Text-reported METH use, but not depressed mood, was associated with poorer MEMS-derived ART adherence. ConclusionsHigh text response rates and good concordance between MEMS-derived and text-reported adherence suggests text messaging is a feasible intervention delivery approach that provides a valid indication of ART adherence. Reductions in METH use among iTAB participants suggest daily health reminders may help attenuate substance use. Further research is needed to substantiate daily text messaging as a harm reduction approach.

Over-adherence to capecitabine: a potential safety issue in breast and colorectal cancer patients.

The aim of the OCTO clinical study was to measure patients' adherence to capecitabine-based treatment. A cohort of ambulatory patients treated with capecitabine monotherapy for either locally advanced or metastatic, breast or colorectal cancer was monitored for 6 cycles. Adherence was assessed in all patients by self-completed questionnaires on disease, pill-count and pharmacological dosage of FBAL (metabolite of capecitabine); and in half of the cohort by electronic medication event monitoring systems (MEMS™) recording the opening times of the device. Forty patients were enrolled between November 2008 and September 2011 and treated by capecitabine for an average of 4.75 cycles (range 1-6). Hand-foot syndrome (HFS) was the most frequently reported toxicity (35% patients), and to a lesser extent fatigue and/or asthenia (21%), nausea and/or vomiting (13%) and diarrhea (11%). In the MEMS™ cohort, 20 patients were included. Patients' adherence was excellent with very few missing occasions (23/2272 records). Close analysis of MEMS™ data revealed unexpected medication patterns, such as patients taking extra days of medication beyond planned cycle, patients taking extra doses per day and patients missing a day of dosing and "compensating" by taking extra the following day (N = 7, 18%). A trend was found between over-adherence and high-grade toxicity (grades 3 and/or 4): OR 4.74 [0.65-45.2], p = 0.13 and higher AUC (p = 0.16). There was a trend towards increased AUC of FBAL in over-adherent patients (p = 0.16). Adherence to oral anticancer chemotherapy was found excellent in this population suggesting over-adherence to capecitabine and potential safety implications for outpatients' drugs.

IMPROVING THERAPEUTIC COMPLIANCE OF DABIGATRAN IN PREVENTING STROKE IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION

Objective: To assess the efficacy of a mixed intervention, educational and reminder calendar of the intake, as a strategy to improve therapeutic compliance with dabigatran in patients with non-valvular atrial fibrillation (NVAF). Design and method: Prospective, longitudinal, multicenter study, carried out in 110 specialized healthcare centers in Spain. 726 patients treated with dabigatran prescribed for stroke prevention were included. A cluster randomization was performed based on two groups: 1) Control Group (CG) as usual clinical practice and Intervention Group (IG) with a mixed strategy: a) Healthcare education and b) Use of a reminder calendar for taking the anticoagulant medication. Three visits took place: baseline and follow up at 6 and 12 months. Compliance was measured using electronic monitors (Medication Event Monitoring System - MEMS). Average compliance percentage (%; Average CP) and daily compliance (%; Daily CP) was calculated. A patient was considered complier when CP was 80–100%. Results: Six hundred twenty-five patients ended the study. There were 315 evaluable subjects in the IG and 310 in the CG, with a mean age of 73,52 ± 8,3 years and 73,32 ± 8,56 respectively. Daily CP was 91,97 % at 6 months and 91,05 % after 12 months in the IG and 82,26 % and 82,63 % in the CG. Average compliance was 90,79 % and 89,20 % in the IG and 64,51 % and 63,22 % in the CG at 6 and 12 months respectively. Significant differences were observed in the Daily CP and Average CP with higher percentages in IG. In the non-compliers group, the number of concomitant drugs, baseline and 6 months SBP values, 6 and 12 months DBP values, baseline, 6 and 12 month weight, and total cholesterol and LDL cholesterol at baseline, 6 and 12 months were significantly higher. The number needed to treat (NNT) at the end of the intervention was 3,84 patients to prevent 1 non-compliance. Conclusions: A mixed intervention with educational and reminder calendar of drug intake, has been proven to be effective as a strategy to improve therapeutic compliance with dabigatran in patients with NVAF. The percentage of compliance with dabigatran was high

An innovative and comprehensive technique to evaluate different measures of medication adherence: The network meta-analysis.

Poor medication adherence is associated with adverse health outcomes and higher costs of care. However, inconsistencies in the assessment of adherence are found in the literature. To evaluate the effect of different measures of adherence in the comparative effectiveness of complex interventions to enhance patients' adherence to prescribed medications. A systematic review with network meta-analysis was performed. Electronic searches for relevant pairwise meta-analysis including trials of interventions that aimed to improve medication adherence were performed in PubMed. Data extraction was conducted with eligible trials evaluating short-period adherence follow-up (until 3 months) using any measure of adherence: self-report, pill count, or MEMS (medication event monitoring system). To standardize the results obtained with these different measures, an overall composite measure and an objective composite measure were also calculated. Network meta-analyses for each measure of adherence were built. Rank order and surface under the cumulative ranking curve analyses (SUCRA) were performed. Ninety-one trials were included in the network meta-analyses. The five network meta-analyses demonstrated robustness and reliability. Results obtained for all measures of adherence were similar across them and to both composite measures. For both composite measures, interventions comprising economic+technical components were the best option (90% of probability in SUCRA analysis) with statistical superiority against almost all other interventions and against standard care (odds ratio with 95% credibility interval ranging from 0.09 to 0.25 [0.02, 0.98]). The use of network meta-analysis was reliable to compare different measures of adherence of complex interventions in short-periods follow-up. Analyses with longer follow-up periods are needed to confirm these results. Different measures of adherence produced similar results. The use of composite measures revealed reliable alternatives to establish a broader and more detailed picture of adherence.

Comparison of Adherence to Glimepiride/Metformin Sustained Release Once-daily Versus Glimepiride/Metformin Immediate Release BID Fixed-combination Therapy Using the Medication Event Monitoring System in Patients With Type 2 Diabetes

PurposeThe purpose of this study was to compare the adherence of the glimepiride/metformin sustained release (GM-SR) once-daily fixed-dose combination and glimepiride/metformin immediate release (GM-IR) BID fixed-dose combination in type 2 diabetes therapies. MethodsAn open-label, randomized, multicenter, parallel-group study was conducted at 11 hospitals in the Republic of Korea. A total of 168 patients with type 2 diabetes treated with >4 mg of glimepiride and 1000 mg of metformin by using free or fixed-dose combination therapy for at least 2 weeks were enrolled. Patients were randomized to receive GM-SR 4/1000 mg once-daily or GM-IR 2/500 mg BID for 24 weeks. Adherence was compared by using the Medication Event Monitoring System (MEMS). FindingsA significant difference in adherence was observed between the 2 groups. Overall adherence, defined by the number of container openings divided by the number of prescribed doses, was 91.7% in the GM-SR group and 88.6% in the GM-IR group (P < 0.001). The percentage of treatment days with the correct number of doses taken was 85.3% in the GM-SR group and 75.1% in the GM-IR group (P < 0.001). The percentage of missed doses was 11.7% in the GM-SR group and 15.3% in the GM-IR group (P < 0.001). The percentage of doses taken in the correct time window and therapeutic coverage were higher in the GM-SR group (P < 0.001). There was no significant difference in glycosylated hemoglobin changes or number of adverse events between the 2 groups. A total of 168 patients randomized to receive GM-SR once daily (86 patients) or GM-IR twice daily (82 patients). Mean Age were 57.8 ± 9.6 years old. Male : female ratio was 47.6 : 52.4 %. Body mass index were 66.3 ± 12.0 kg/m2, Diabetes duration were 10.5 ± 6.6 years. ImplicationsThis study showed that patient adherence with GM-SR once daily was significantly better than with GM-IR BID. ClinicalTrials.gov identifier: NCT01620489.

PHP185 - Patterns of Non-Adherence to Oral Antiviral Drugs

Even if a patient misses a number of doses of a once-daily oral drug, the therapeutic effect will be maintained if there are no occurrences of consecutively missed doses that exceed the duration of the drug’s effect. We previously calculated the frequency of consecutively missed doses values of ≥2, ≥3, and ≥4 within a 30-day period with the assumption that distributions of missed doses were purely random (Clin Pharmacokinet [2017] 56; 1435-1440). Here, we determine the observed frequencies of ≥2, ≥3, and ≥4 consecutively missed doses using data recorded from patients taking a once daily oral anti-HIV drug. Medication event monitoring system (MEMS) data were extracted from the iAdherence online database for a 30-day period for 555 patients taking once-daily HIV drug therapy. We recorded the number of days with missed doses and occurrences of ≥2, ≥3, or ≥4 consecutively missed doses. The observed frequencies of ≥2, ≥3, and ≥4 consecutively missed doses were compared to a theoretical random distribution of misses using the Wilcoxon signed-rank test. The frequencies of 0, 1, and ≥2 missed daily doses were 0.279, 0.312, and 0.409, respectively. The frequencies of ≥2, ≥3, and ≥4 consecutively missed doses were 0.184, 0.110, and 0.065, respectively. The probabilities that the observed frequencies of ≥2, ≥3, and ≥4 consecutively missed doses were as expected from a random distribution of missed doses were P=0.345, P<0.01, and P<0.01, respectively. Observed runs of ≥3 and ≥4 consecutively missed doses—and hence loss of therapeutic effect for drugs of duration of action of <3 and <4 days, respectively—occurred more frequently than expected if missed doses were randomly distributed.

Validation of the electronic prescription as a method for measuring treatment adherence in hypertension

ObjectiveTo validate electronic prescriptions (e-prescriptions) as a method for measuring treatment adherence in patients with hypertension. MethodsThis prospective study initially included 120 patients treated for hypertension in primary care centers. Adherence was measured using the gold standard, the medication event monitoring system (MEMS), versus the index test, the e-prescription program, at baseline and at 6, 12, 18 and 24 months. We calculated the adherence rate using the MEMS and the medication possession ratio (MPR) for the e-prescriptions. We considered patients adherent if they had an adherence rate of 80% to 100%. To validate the e-prescription, we obtained measures of diagnostic accuracy, the Kappa concordance index, and the area under the ROC curve (AUC). ResultsWe included 102 patients. Overall adherence was 77.4% by MEMS (95%CI: 66.8-88) and 80.4% (95%CI: 70.3-90.5) by MPR. At 24 months, sensitivity was 87% and specificity, 93.7%. The AUC was 0.903 (95%CI: 0.817-0.989). ConclusionMeasures of treatment adherence were not significantly different between e-prescription and gold standard at most visits, and the e-prescription showed good discriminatory diagnostic capacity. Practice implicationsIf patients are included in an e-prescription program for at least 2 years, e-prescription is an inexpensive method to measure adherence in hypertension.

Brief Report: Higher ART Adherence Is Associated With Lower Systemic Inflammation in Treatment-Naive Ugandans Who Achieve Virologic Suppression.

Residual systemic inflammation persists despite suppressive antiretroviral therapy (ART) and is associated with non-AIDS clinical outcomes. We aimed to evaluate the association between ART adherence and inflammation in Ugandans living with HIV who were predominantly receiving nevirapine-based ART with a thymidine analog backbone and were virologically suppressed by conventional assays. Plasma concentrations of interleukin-6 (IL-6), D-dimer, soluble (s)CD14, sCD163, and the kynurenine/tryptophan ratio, in addition to CD8 T-cell activation, were measured at baseline and 6 months after ART initiation in treatment-naive adults who achieved an undetectable plasma HIV RNA (<400 copies/mL) at their 6-month visit. Adherence was measured through medication event monitoring system and calculated as the ratio of observed/prescribed device openings per participant. We fit adjusted linear regression models to estimate the association between ART adherence and the log-transformed plasma concentrations of inflammatory biomarkers. We evaluated 282 participants (median age, 35 years; 70% women). The median (interquartile range) adherence was 93% (84-98). In the adjusted analyses, for every 10% increase in average ART adherence, we found a 15% [P < 0.0001; 95% confidence interval (CI), -21.0 to -7.9], 11% (P = 0.017; 95% CI, -18.3 to -2.0), and 3% (P = 0.028; 95% CI, -5.0 to -0.3) decrease in IL-6, D-dimer, and sCD14, respectively. Higher ART adherence was associated with lower levels of biomarkers of inflammation, immune activation, and coagulopathy among Ugandans living with HIV who achieved viral suppression shortly after ART initiation. This suggests that ART adherence could have biological consequences beyond viral suppression. Whether ART adherence optimization in virologically suppressed individuals could reduce residual inflammation remains unknown.

A Systematic Review on Promoting Adherence to Antiretroviral Therapy in HIV-infected Patients Using Mobile Phone Technology.

Adherence to antiretroviral therapy (ART) is paramount to successful long-term suppression of human immunodeficiency virus (HIV). For poorly adherent patients with HIV, barriers to remaining adherent may be overcome by the implementation of targeted interventions delivered via mobile devices. This systematic review is focused specifically on mobile phone technologies to deliver adherence interventions in HIV/acquired immunodeficiency syndrome (AIDS) populations. This review (PROSPERO #CRD42017065131) systematically extracted data from published literature from five databases on mobile phone interventions to improve adherence to ART for HIV. The reported studies had been conducted between 2007 and 2017. Risk of bias was assessed using the Cochrane method ranking each criterion as low, high, or unclear risk of bias. Of the 835 articles returned, we identified 26 randomized controlled trials (RCTs), retrospective and prospective cohort trials, or mixed method studies with a comparison group that fit criteria for inclusion. No standard measure of adherence was consistent throughout the examined studies, and assessments by self-report, pill counting, and medication event monitoring system (MEMS) were utilized. The studies reported mixed results, with 17 reporting significant improvements to adherence, 3 reporting improvements without supplying p-values, and 6 reporting no significant change or a reduction in adherence. The mixed nature of the results exemplifies the need for more comprehensive approaches and larger scale trials to confirm results observed in limited cohort sizes. To better retain satisfactory adherence within the HIV population, and especially in low-resource settings, we recommend that future interventions incorporate multiple strategies: mobile-based reminders, social support structures, and personalized content.

Prospective investigation of social support, coping, and depressive symptoms: A model of adherence to endocrine therapy among women with breast cancer.

Nonadherence reduces the effectiveness of behavioral change regimens for promoting health and decreasing morbidities and mortality. Such is the case with endocrine therapies, which lower the likelihood of recurrence in the approximately 70% of women with hormone receptor-positive breast cancers. This investigation tests a model of contributors to objective adherence. Women with breast cancer receiving their 1st endocrine therapy prescription (N = 130) were recruited from a large community oncology breast clinic. Participants completed three interview and questionnaire sessions at prescription initiation, one month and four months later. Questionnaires addressed patients' experience with cancer and included measures of coping (COPE and Emotional Approach Coping), social support (Interpersonal Support Evaluation List), and depressive symptoms (Center for Epidemiologic Studies Depression Scale). At the initial appointment, participants were provided a Medication Event Monitoring System (MEMS) cap to assess adherence; the MEMS cap was collected at the 4-month follow-up appointment. Structural equation modeling offered partial support for a mediational model, χ2(68, N = 130) = 77.47, p = .202, root-mean-square error of approximation = .03, comparative fit index = .97, standardized root-mean-square residual = .06. Greater social support at prescription initiation was associated with lower depressive symptoms 1 month later, which in turn were associated with higher objective adherence (MEMS) four months after study entry, controlling for significant covariates (p < .05). Use of avoidance-oriented coping was not statistically significantly related to depressive symptoms (p > .05). This model informs theory regarding medication adherence as well as intervention development for women prescribed adjuvant endocrine therapy. (PsycINFO Database Record

Effectiveness of a multicomponent self-management intervention for adults with epilepsy (ZMILE study): A randomized controlled trial

BackgroundThe objective of the ZMILE study was to compare the effectiveness of a multicomponent self-management intervention (MCI) with care as usual (CAU) in adult patients with epilepsy (PWE) over a six-month period. MethodsParticipants (PWE & relative) were randomized into intervention or CAU groups.Self-report questionnaires were used to measure disease-specific self-efficacy as the primary outcome measure and general self-efficacy, adherence, seizure severity, emotional functioning, quality of life, proactive coping, and side-effects of antiepileptic drugs (AED) as secondary outcome measures. Instruments used at baseline and during a six-month follow-up period were the following: disease-specific self-efficacy (Epilepsy Self-Efficacy Scale [ESES], General Self-Efficacy Scale [GSES]); adherence (Medication Adherence Scale [MARS] and Medication Event Monitoring System [MEMS]); seizure severity (National Hospital Seizure Severity Scale [NHS3]); emotional well-being (Hospital Anxiety and Depression Scale [HADS]); quality of life (Quality of Life in Epilepsy [QOLIE-31P]); proactive coping (Utrecht Proactive Coping Competence [UPCC]); and side-effects of antiepileptic drugs [SIDAED]. Multilevel analyses were performed, and baseline differences were corrected by inclusion of covariates in the analyses. ResultsIn total, 102 PWE were included in the study, 52 of whom were in the intervention group. On the SIDAED and on three of the quality of life subscales QOLIE-31P, a significant difference was found (p<0.05) in the intervention group. Self-efficacy, however, showed no significant differences between the MCI and the CAU groups. None of the other outcome measures showed any significant difference between the two groups. SignificanceAlthough we found no statistically significant difference in the primary outcome measure, disease-specific self-efficacy, this MCI could prove promising, since we found improvement in some domains of quality of life in epilepsy scale and a decrease in AED side-effects in the MCI group compared with the CAU group.

A lecithin phosphatidylserine and phosphatidic acid complex (PAS) reduces symptoms of the premenstrual syndrome (PMS): Results of a randomized, placebo-controlled, double-blind clinical trial

Many women experience emotional and physical symptoms around the time of ovulation and more so before menstruation interfering with their daily normal life also known as premenstrual syndrome (PMS). Recent observational data suggest that supplementation with Lipogen's phosphatidylserine (PS) and phosphatidic acid (PA) complex (PAS) alleviates these PMS symptoms. The aim of this study was to confirm these observations on the effects of PAS on PMS symptom severity within a controlled clinical trial setting. Forty women aged 18-45 years with a diagnosis of PMS were assigned to either take PAS (containing 400mgPS & 400mgPA per day) or a matching placebo. The study comprised 5 on-site visits including 1 baseline menstrual cycle followed by 3 treatment cycles. Treatment intake was controlled for by using an electronic device, the Medication Event Monitoring System (MEMS®). Primary outcome of the study was the PMS symptoms severity as assessed by using the Daily Record of Severity of Problems (DRSP). Further, SIPS questionnaire (a German version of the Premenstrual Symptoms Screening Tool (PSST)), salivary hormone levels (cortisol awakening response (CAR) and evening cortisol levels) as well as serum levels (cortisol, estradiol, progesterone and corticosteroid binding globulin (CBG)) were assessed. PMS symptoms as assessed by the DRSP Total score showed a significantly better improvement (p=0.001) over a 3 cycles PAS intake as compared to placebo. In addition, PAS treated women reported a greater improvement in physical (p=0.002) and depressive symptoms (p=0.068). They also reported a lower reduction of productivity (p=0.052) and a stronger decrease in interference with relationships with others (p=0.099) compared to the placebo group. No other DRSP scale or item showed significant results. Likewise, the reduction in the number of subjects fulfilling PMS or premenstrual dysphoric disorder (PMDD) criteria as classified by the SIPS did not differ between the PAS and the placebo group. For the biomarkers, the salivary cortisol percentage increase of the CAR was significantly less pronounced in the follicular phase of cycle 4 than in the follicular phase of cycle 1 for subjects taking PAS when compared to subjects taking placebo (p=0.018). Furthermore, the change of serum cortisol levels between visit 1 and visit 5 differed significantly between groups (p=0.043). While serum cortisol levels of PAS treated females slightly decreased between visit 1 and visit 5, cortisol levels of females treated with placebo increased. For all other biomarkers, no treatment effects were observed over the 4 cycles study period. Overall, this study confirms that a daily intake of PAS, containing 400mgPS and 400mgPA, can be considered as safe. Results substantiate the efficacy of PAS in reducing symptoms of PMS. In view of the recent inclusion of severe PMS symptoms (PMDD) in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the positive results of this clinical study merits consideration of developing the PAS complex as a botanical drug for treatment of PMDD. The study is registered at Deutsches Register Klinischer Studien with the registration number DRKS00009005.

Predictors of Daily Adherence to Naltrexone for Alcohol Use Disorder Treatment During a Mobile Health Intervention.

Adherence to medications for treating alcohol use disorder (AUD) is poor. To identify predictors of daily naltrexone adherence over time, a secondary data analysis was conducted of a trial evaluating a mobile health intervention to improve adherence. Participants seeking treatment for AUD (n = 58; Mage = 38 years; 71% male) were prescribed naltrexone for 8 weeks. Adherence was tracked using the Medication Event Monitoring System (MEMS). In response to daily text messages, participants reported the previous day's alcohol use, craving, and naltrexone side effects. Using multilevel structural equation modeling (MSEM), we examined baseline dispositional factors and within-person, time-varying factors as predictors of daily adherence. Naltrexone adherence decreased over time. Adherence was higher on days when individuals completed daily mobile assessments relative to days when they did not (odds ratio [OR] = 2.53, 95% confidence interval [CI] 1.61 to 3.98), irrespective of intervention condition. Days when individuals drank more than their typical amount were related to lower next-day adherence (OR = 0.93, 95% CI 0.88 to 0.99). A similar pattern was supported for craving (OR = 0.88, 95% CI 0.79 to 0.98). Weekend days were associated with lower adherence than weekdays (OR = 0.71, 95% CI 0.58 to 0.86); this effect was partly mediated by heavier daily drinking (indirect effect = -0.02, 95% CI -0.04 to -0.003) and stronger-than-usual craving (indirect effect = -0.01, 95% CI -0.02 to 0.00) on weekend days. The results further demonstrate the need to improve adherence to AUD pharmacotherapy. The present findings also support developing interventions that target daily-level risk factors for nonadherence. Mobile health interventions may be one means of developing tailored and adaptive adherence interventions.

Relationship between electronically measured medication adherence and vision-related quality of life in a cohort of patients with open-angle glaucoma

ObjectiveTo investigate whether electronically measured medication adherence is associated with vision-related quality of life (VRQoL) in patients with open-angle glaucoma.Methods and analysisThis is a 3-year prospective cohort study of 79...

Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, use, and effectiveness in an open-label demonstration project in East Africa.

Background: Pre-exposure prophylaxis (PrEP) can provide high protection against HIV infection and is a recommended intervention for HIV-negative persons with substantial HIV risk. Demonstration projects conducted in diverse settings worldwide illustrate practical examples of how PrEP can be delivered. This manuscript presents estimates of effectiveness and patterns of PrEP use within a two-year demonstration project of PrEP for HIV-negative members of heterosexual HIV serodiscordant couples in East Africa. Methods: The PrEP delivery model integrated PrEP into HIV treatment services, prioritizing PrEP use for HIV-negative partners within serodiscordant couples before and during the first 6 months after the partner living with HIV initiated antiretroviral therapy (ART). We measured PrEP uptake through pharmacy records and adherence to PrEP through medication event monitoring system (MEMS) bottle caps and quantification of tenofovir in plasma among a random sample of participants. We estimated HIV infections prevented using a counterfactual cohort simulated from the placebo arm of a previous PrEP clinical trial. Results: We enrolled 1,010 HIV serodiscordant couples that were naïve to ART and PrEP. Ninety-seven percent of HIV-negative partners initiated PrEP. Objective measures suggest high adherence: 71% of HIV-negative participants took ≥80% of expected doses, as recorded via MEMS, and 81% of plasma samples had tenofovir detected. Four incident HIV infections were observed (incidence rate=0.24 per 100 person-years), a 95% reduction (95% CI 86-98%, p<0.0001) in HIV incidence, relative to estimated HIV incidence for the population in the absence of PrEP integrated into HIV treatment services. Conclusions: PrEP uptake and adherence were high and incident HIV was rare in this PrEP demonstration project for African HIV-negative individuals whose partners were known to be living with HIV. Delivery of PrEP to HIV-negative partners within HIV serodiscordant couples was feasible and should be prioritized for wide-scale implementation.

Pre-exposure prophylaxis for HIV-negative persons with partners living with HIV: uptake, use, and effectiveness in an open-label demonstration project in East Africa

Background: Pre-exposure prophylaxis (PrEP) can provide high protection against HIV infection and is a recommended intervention for HIV-negative persons with substantial HIV risk. Demonstration projects conducted in diverse settings worldwide illustrate practical examples of how PrEP can be delivered. This manuscript presents estimates of effectiveness and patterns of PrEP use within a two-year demonstration project of PrEP for HIV-negative members of heterosexual HIV serodiscordant couples in East Africa. Methods: The PrEP delivery model integrated PrEP into HIV treatment services, prioritizing PrEP use for HIV-negative partners within serodiscordant couples before and during the first 6 months after the partner living with HIV initiated antiretroviral therapy (ART). We measured PrEP uptake through pharmacy records and adherence to PrEP through medication event monitoring system (MEMS) bottle caps and quantification of tenofovir in plasma among a random sample of participants. We estimated HIV infections prevented using a counterfactual cohort simulated from the placebo arm of a previous PrEP clinical trial. Results: We enrolled 1,010 HIV serodiscordant couples that were naïve to ART and PrEP. Ninety-seven percent of HIV-negative partners initiated PrEP. Objective measures suggest high adherence: 71% of HIV-negative participants took ≥80% of expected doses, as recorded via MEMS, and 81% of plasma samples had tenofovir detected. Four incident HIV infections were observed (incidence rate=0.24 per 100 person-years), a 95% reduction (95% CI 86-98%, p<0.0001) in HIV incidence, relative to estimated HIV incidence for the population in the absence of PrEP integrated into HIV treatment services. Conclusions: PrEP uptake and adherence were high and incident HIV was rare in this PrEP demonstration project for African HIV-negative individuals whose partners were known to be living with HIV. Delivery of PrEP to HIV-negative partners within HIV serodiscordant couples was feasible and should be prioritized for wide-scale implementation.

Telemonitoring-based feedback improves adherence to non-vitamin K antagonist oral anticoagulants intake in patients with atrial fibrillation.

To evaluate the effect of telemonitoring on adherence to non-vitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients. A randomized, single-blind, crossover, controlled trial in 48 AF patients on once or twice daily (OD or BID) NOAC. The Medication Event Monitoring System tracked NOAC intake during three phases of 3months each: daily telemonitoring, telemonitoring with immediate telephone feedback in case of intake errors, and an observation phase without daily transmissions. Unprotected days were defined as ≥ 3 or ≥ 1 consecutively missed doses for a BID or OD NOAC, respectively, or excess dose intake. Cost-effectiveness was calculated based on anticipated stroke reduction derived from patients' risk profile and measured intake. Persistence over the entire study was 98%. Telemonitoring-only already led to very high taking and regimen adherence (97.4% respectively 93.8%). Nevertheless, direct feedback further improved both to 99.0% and 96.8%, respectively (P < 0.001 respectively P = 0.002). Observation without daily monitoring resulted in a significant waning of taking adherence (94.3%; P = 0.049). Taking adherence was significantly higher for OD compared to BID NOAC, although unprotected days were similar. Feedback intervention had an incremental cost of €344289 to prevent one stroke, but this could be as low as €15488 in high-risk patients with low adherence and optimized technology. Telemonitoring resulted in high NOAC adherence due to the notion of being watched, as evidenced by the rapid decline during the observation period. Feedback further optimized adherence. Telemonitoring with or without feedback may be a cost-effective approach in high-risk patients deemed poorly adherent.

Validation of a Short Adherence Questionnaire for Children Living with HIV on Antiretroviral Therapy in Kenya

Background:There are few validated tools to measure adherence for children living with HIV. We identified questionnaire items for caregivers of Kenyan children aged <15 years living with HIV.Methods:Caregiver–child dyads were followed for 6 months. At monthly visits, the child’s HIV provider administered a 10-item questionnaire to the caregiver. Children were given electronic dose monitors (Medication Event Monitoring Systems [MEMS]). Correlation between questionnaire items and dichotomized MEMS adherence (≥90% doses taken versus <90%) was investigated using logistic regression models.Results:In 95 caregiver–child dyads, mean age of children (40% female) was 8.3 years. Items associated with higher odds of MEMS adherence in multivariable analysis included the father giving the child medication, being enrolled in a nutrition program, and the caregiver reporting no difficulties giving the child medication.Conclusion:Providers typically ask about missed doses, but asking about caregiver responsibilities and difficulties in giving the child medication may better detect suboptimal adherence.