Electronic Event Monitoring Research Articles

Evaluating the role of baseline geriatric assessment in predicting adherence to oral targeted therapies and outcomes in older adults with non-Hodgkin lymphoma.

12043 Background: Oral targeted therapies (OTT) have transformed the treatment landscape of Non-Hodgkin lymphoma (NHL). However, measuring, defining and optimizing adherence to OTT remains a challenge. Prior studies have reported variable adherence rates (12-100%) to OTT in cancer patients (pts), with suboptimal adherence associated with inferior outcomes. In older adults (OA), geriatric syndromes (GS) such as polypharmacy and cognitive impairment can impact adherence. While geriatric assessment (GA) can predict chemotherapy-related toxicity in OA, its utility in NHL pts on OTT is unknown. In this pilot study, we evaluate the role of GA in predicting adherence and outcomes in NHL pts on OTT. We also report the feasibility of using MEMS Cap, an electronic event monitoring system, to measure adherence in this population. Methods: Pts ≥70 years (yrs) with NHL, initiating/receiving OTT were included. A GA was performed at baseline; pt, disease, and OTT characteristics were recorded. Pts were followed monthly for the first 3 months (mos), then every 3 mos for 1 year. Primary endpoint was treatment adherence rate, measured using both subjective [brief adherence rating scale (BARS)] and objective (pill counts and MEMS cap) methods. Progression free survival (PFS) was measured from time of therapy initiation to disease progression or death. Results: Of the 54 pts screened, 25 were enrolled. Median age was 77 yrs (71-93 yrs), 21 pts had chronic lymphocytic leukemia, 3 had mantle cell lymphoma and 1 had marginal zone lymphoma. Most frequently used OTT were ibrutinib (n = 17) and venetoclax (n = 5). Most pts (72%) were on OTT at study entry. Median time on therapy was 16.4 mos (1.9-44.6 mos). GS included cognitive impairment (28%), depression (24%), polypharmacy (92%) and recent falls (12%); 48% pts had ≥2 GS. Nine pts (36%) had impaired 4-meter gait speed and/or timed-up-and-go; 20 pts (80%) had an adjusted CIRS-G score of ≥6. So far, pts have completed a median follow up of 3.3 mos. BARS was the most consistent measure of adherence used (63/63 visits, 100%). MEMS Cap and pill counts were used at 13% and 8% visits respectively. Only 5 pts used the MEMS Cap, mostly due to packaging incompatibility (44%-pill box, 32%-blister packs). Median adherence was 100% (range, 70%-100%) with no pts missing > 7 days of prescribed doses. Five pts (20%) required dose interruptions, mostly due to adverse events. Six pts discontinued therapy and 2 pts died of unrelated causes. Median PFS was not reached. Chronological age and presence of a GS were not associated with adherence rate or outcomes. Conclusions: Despite presence of ≥2 geriatric syndromes in 48% of older adults with NHL on OTT, self-reported adherence remains high ( > 99%) in this group. The MEMS Cap device has poor applicability in measuring adherence to OTT due to pill package incompatibility and increasing use of virtual/tele visits.

Women's Reports of Barriers to and Facilitators of Oral Medication Adherence During Ovarian Stimulation: A Mixed Methods Pilot Study.

Background:Adherence to lifestyle modification recommendations remains problematic for women undergoing fertility treatment, raising concerns about the extent to which women adhere to prescribed medication regimens. Limited data have shown suboptimal oral medication adherence rates of 19% to 74%. The objective of this study was to explore what women perceive as barriers to and facilitators of oral medication adherence during fertility treatment cycles.Methods:An exploratory mixed methods pilot study was conducted among a sample of 30 women who were actively taking one to two cycles of letrozole or clomiphene citrate for ovarian stimulation in conjunction with intrauterine insemination cycles. Medication adherence barriers were measured using a 20-item survey. Medication adherence facilitators and personal experiences with fertility treatment were assessed with structured interviews. Medication adherence was assessed with electronic event monitoring.Results:The overall medication adherence median was 0.97 with a range of 0.75 to 1.00, and nine women (50%) demonstrated perfect adherence. The most commonly reported barriers were recently feeling sad, down, or blue (53%), and taking medication more than once per day (40%). Women with higher barrier scores had significantly lower medication adherence scores (p=0.02) compared to women with lower total barrier scores. Facilitators included using physical aides as reminders (60%) and establishing a daily routine (50%). No significant correlation was found between medication adherence scores and facilitators.Conclusion:The dynamic interplay between perceived barriers and facilitators and women’s medication-taking patterns could influence whether or not medication regimens are followed correctly.

Patterns of adherence to diuretics, dietary sodium and fluid intake recommendations in adults with heart failure

Background: Three behaviors advocated to minimize fluid-related hospitalizations in patients with heart failure (HF) are restricted sodium and fluid intake and consistent oral diuretic use. Adherence to behaviors intended to decrease risk of hospitalization is believed to vary over time, but surprisingly little research has addressed patterns of adherence in HF patients. Objective: To describe patterns over time of 3 recommended self-care behaviors (i.e., diet, fluid intake, and diuretic dosing) in adults with HF and to determine how time and behavior influenced adherence rates. Methods: We enrolled 24 adults hospitalized for a HF exacerbation and discharged on a loop diuretic into a descriptive, longitudinal pilot study. Over 3-months, diuretic use was measured using electronic event monitoring, and participants were telephoned regularly to assess sodium and fluid intake. Data were summarized for each 2-week intervals. Results: The overall adherence rates were 42.4% for low sodium diet, 96.4% for fluid restriction, and 84.7% for the diuretic regimen. Early after hospital discharge, medication adherence was the highest, and dietary adherence was the lowest, but adherence to diet and diuretic use decreased significantly over time. Conclusion: Although participants were just discharged from the hospital after an acute exacerbation of HF, all three behavioral patterns decreased markedly over the 3-month follow-up period.

Effects of staff training and electronic event monitoring on long-term adherence to lung-protective ventilation recommendations

PurposeTo investigate long-term effects of staff training and electronic clinical decision support (CDS) on adherence to lung-protective ventilation recommendations. Materials and methodsIn 2012, group instructions and workshops at two surgical intensive care units (ICUs) started, focusing on standardized protocols for mechanical ventilation and volutrauma prevention. Subsequently implemented CDS functions continuously monitor ventilation parameters, and from 2015 triggered graphical notifications when tidal volume (VT) violated individual thresholds. To estimate the effects of these educational and technical interventions, we retrospectively analyzed nine years of VT records from routine care. As outcome measures, we calculated relative frequencies of settings that conform to recommendations, case-specific mean excess VT, and total ICU survival. ResultsAssessing 571,478 VT records from 10,241 ICU cases indicated that adherence during pressure-controlled ventilation improved significantly after both interventions; the share of conforming VT records increased from 61.6% to 83.0% and then 86.0%. Despite increasing case severity, ICU survival remained nearly constant over time. ConclusionsStaff training effectively improves adherence to lung-protective ventilation strategies. The observed CDS effect seemed less pronounced, although it can easily be adapted to new recommendations. Both interventions, which futures studies could deploy in combination, promise to improve the precision of mechanical ventilation.

Medication adherence outcomes of 771 intervention trials: Systematic review and meta-analysis.

Excellent medication adherence contributes to decreases in morbidity, mortality, and health care costs. Although researchers have tested many interventions to increase adherence, results are sometimes conflicting and often unclear. This systematic review applied meta-analytic procedures to integrate primary research that tested medication adherence interventions. Comprehensive searching completed in 2015 located 771 published and unpublished intervention studies with adherence behavior outcomes. Random-effects model analysis calculated standardized mean difference effect sizes. Meta-analytic moderator analyses examined the association between adherence effect sizes and sample, design, and intervention characteristics. Analyses were conducted in 2016. A standardized mean difference effect size of 0.290 comparing treatment and control groups was calculated. Moderator analyses revealed larger effect sizes for habit-based and behavioral-targeted (vs. cognitive-focused) interventions. The most effective interventions were delivered face-to-face, by pharmacists, and administered directly to patients. Effect sizes were smaller in studies with older and homeless participants. Risks of bias were common; effect sizes were significantly lower among studies with masked data collectors and intention-to-treat analyses. The largest effect sizes were reported by studies using medication electronic event monitoring and pill count medication adherence measures. Publication bias was present. This most comprehensive review to date documented that, although interventions can increase adherence, much room remains for improvement. Findings suggest health care providers should focus intervention content on behavioral strategies, especially habit-based interventions, more so than cognitive strategies designed to change knowledge and beliefs.

Meta-analyses of Theory Use in Medication Adherence Intervention Research.

This systematic review applied meta-analytic procedures to integrate primary research that examined theory- or model-linked medication adherence interventions. Extensive literature searching strategies were used to locate trials testing interventions with medication adherence behavior outcomes measured by electronic event monitoring, pharmacy refills, pill counts, and self-reports. Random-effects model analysis was used to calculate standardized mean difference effect sizes for medication adherence outcomes. Codable data were extracted from 146 comparisons with 19,348 participants. The most common theories and models were social cognitive theory and motivational interviewing. The overall weighted effect size for all interventions comparing treatment and control participants was 0.294. The effect size for interventions based on single-theories was 0.323 and for multiple-theory interventions was 0.214. Effect sizes for individual theories and models ranged from 0.041 to 0.447. The largest effect sizes were for interventions based on the health belief model (0.477) and adult learning theory (0.443). The smallest effect sizes were for interventions based on PRECEDE (0.041) and self-regulation (0.118). These findings suggest that theory- and model-linked interventions have a significant but modest effect on medication adherence outcomes.

Medication adherence interventions that target subjects with adherence problems: Systematic review and meta-analysis.

Inadequate medication adherence is a pervasive, under-recognized cause of poor health outcomes. Many intervention trials designed to improve medication adherence have targeted adults with adherence problems. No previous reviews have synthesized the effectiveness of medication adherence interventions focused on subjects with medication adherence difficulties. This systematic review and meta-analysis synthesized findings from medication adherence intervention studies conducted among adults with medication adherence difficulties. Primary research studies were eligible for inclusion if they tested an intervention designed to increase medication adherence among adults with documented adherence difficulties and reported medication adherence behavior outcomes. Comprehensive search strategies of 13 computerized databases, author and ancestry searches, and hand searches of 57 journals were used to locate eligible primary research. Participant demographics, intervention characteristics, and methodological features were reliably coded from reports along with medication adherence outcomes. Effect sizes for outcomes were calculated as standardized mean differences, and random effects models were used to estimate overall mean effects. Exploratory dichotomous and continuous variable moderator analyses were employed to examine potential associations between medication adherence effect size and sample, intervention, and methodological characteristics. Data were extracted from 53 reports of studies involving 8243 individual primary study participants. The overall standardized mean difference effect size for treatment vs. control subjects was 0.301. For treatment pre- vs. post-intervention comparisons, the overall effect size was 0.533. Significantly larger effect sizes were associated with interventions incorporating prompts to take medications than interventions lacking medication prompts (0.497 vs. 0.234). Larger effect sizes were also found for interventions that linked medication taking with existing habits compared to interventions that did not (0.574 vs. 0.222). Effect sizes were largest among studies that measured adherence by pill counts or electronic event monitoring systems. Analysis of study design features identified several potential risks of bias. Statistically significant publication bias was detected, but adherence effect sizes were not significantly associated with other risks of bias. These findings document that interventions targeting individuals with medication adherence problems can have modest but significant effects on medication-taking behavior. The findings support the use of behavioral strategies such as prompts and linking medications to habits to increase medication adherence in adults with adherence challenges. Face-to-face interventions appear to be critical for patients who have experienced past problems with medication adherence.

P4-12-02: The Association of Anastrozole Adherence and Cognitive Function in Breast Cancer.

Abstract Background: Women with breast cancer experience deterioration in cognitive function with adjuvant therapy. Little is known about whether declines in cognitive function are associated with nonadherence to oral hormonal therapy over time. We investigated anastrozole adherence over time and its association with cognitive function over the first 12 months of therapy in women with breast cancer. Methods: Using a prospective cohort design, 169 women with early stage breast cancer were monitored for 12 months 1) continuously for their adherence to anastrozole using electronic event monitoring and 2) objectively for cognitive function via a neuropsychological battery every 6 months for the first 12 months of hormonal therapy. Adherence data were summarized monthly as to the number of doses taken as the percentage of prescribed doses taken and the timing of doses taken as the percentage of days with correct intake and the percentage of doses with correct timing. Six cognitive factors, derived via exploratory factor analysis applied to the neuropsychological battery, were used for analysis. Data were analyzed using descriptive and longitudinal methods. Results: Participants were white (n=166, 98.2%), well-educated (Mean=15.1 years; SD=2.9, range=10-26) and on average 61.1 years of age (SD=5.9, range=46-75). Most had stage 1 breast cancer (n=123, 72.8%) and were prescribed anastrozole either alone (n=110, 65.1%) or immediately after chemotherapy (n=59, 34.9%). Initial levels of adherence were fairly high based on number of (Mean=89.1, SD=27.1, range=0-111.1) and timing of doses taken (Days with correct intake: Mean=86.4, SD=26.8, range=0-100; Doses with correct timing: Mean=83.6, SD=29.8, range=0-100); however, adherence decreased over the first 12 months of therapy (p<.05) in terms of the number of and timing of doses taken and regardless of chemotherapy use. Specifically, we found a linear decrease for the percentage of prescribed doses taken (linear: t=-2.97, p=.0035); however, nonlinear declines were observed for both the percentage of days with correct intake (linear: t=-3.33, p=.0011; quadratic: t=2.10, p=.0371) and the percentage of doses taken at the correct time (linear: t=-3.38, p=.0009; quadratic: t=2.28, p=.0242), suggesting a slowing of the rate of decline in adherence related timing of doses for months 9 through 12. We found that a decrease in executive functioning was related to lower percentages of prescribed doses taken (p=.06) and doses taken at the correct time (p=.06) from pretreatment to 6 months post-anastrozole initiation and even greater evidence (p<.05) from pretreatment to 12 months post-anastrozole initiation. From 7 to 12 months post-anastrozole initiation, we found that a decrease in visual learning and memory was related to lower percentages of prescribed doses taken (p=.04), days with correct intake (p=.04), and doses taken at the correct time (p=.03), while a decrease in attention was related to a lower percentage of days with correct intake (p=.04). Conclusions: These results suggest that breast cancer survivors who experience deterioration in cognitive function tend to have lower adherence. Efforts should be made to develop interventions to compensate for declines in cognitive function and to improve anastrozole adherence. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P4-12-02.

A qualitative study of persons who are 100% adherent to antiretroviral therapy

This qualitative study examined the medication-taking behaviors and attitudes of participants determined to be 100% adherers to antiretroviral therapy from a NIH-funded study testing a 12-week telephone adherence intervention. Using open-ended questions, interviewers collected data on a sample of 13 informants, whose medication adherence to a randomly selected antiretroviral medication was 100%, based on a 30-day data collection using electronic event monitoring (EEM). The analysis revealed ‘successful medication management’ as the core category or main theme. The participants achieved success with medication adherence through managing specific areas (regimen, self and environment). By adopting realistic expectations and pragmatic attitudes, adherence is fostered when medication taking is a priority, when patients believe in the efficacy of their medications and when there is a strong patient/provider relationship. Future research is needed to develop tailored interventions using strategies identified by this population. Further in-depth examination of medication-taking behaviors in 100% adherers may be useful in developing individualized programs to maximize adherence to antiretroviral therapy in the clinical setting.

Effect of Personal and Cultural Beliefs on Medication Adherence in the Elderly

Approximately 50% of patients across all age groups with varied types of medical conditions do not adhere to their prescribed medication regimens. Medication nonadherence is common in older adults who are often prescribed medications for age-related chronic disorders. The purpose of this paper is to investigate the effect of personal and cultural beliefs on older adults' medication adherence through a review of research studies published in journals across different disciplines. A systematic literature search using ten databases found 14 articles meeting the inclusion criteria. Belief-laden variables including self-efficacy (i.e. the belief that one can perform a specific behaviour under differing conditions), medication efficacy, confidence in the physician's knowledge, perceptions about natural products and home remedies, beliefs of control (over one's health), and illness perceptions were found to be significantly related to medication adherence among older adults. However, several measurement, design and sampling problems were identified in this review. The majority of the studies in the review evaluated older adults' medication adherence by self-report and used cross-sectional designs and convenience samples. Future studies should utilise prospective longitudinal designs and a more objective measure of medication adherence, such as electronic event monitoring, when examining factors related to older adults' medication adherence. Future research should also evaluate belief-related variables in larger and more ethnically diverse samples of older adults. Implications for assessment and intervention are evident from this literature review of the effect of personal and cultural beliefs on medication adherence in older adults.

Prevalence of prednisolone (non)compliance in adult liver transplant recipients

Limited evidence is available concerning (non)compliance with the immunosuppressive regimen in adult liver transplant recipients. In our study we prospectively assessed prednisolone (non)compliance in 108 adult liver transplant recipients using electronic event monitoring (EEM) in an outpatient setting. The EEM is a pill bottle fitted with a cap containing a microelectronic circuit that registers date and time of bottle openings and closings. Median taking compliance was 100% (range 60-105%), median dosing compliance was 99% (range 58-100%); median timing compliance (TIC) was 94% (42-100%). A drug holiday (DH) of > or =48 h was found in 39% of the patients of > or =72 h in 16% of the patients. Using EEM in liver transplant recipients, we found an overall high level of compliance for prednisolone, except that TIC was low in about one third of the patients. Age below 40 years was found a significant risk factor for decreased TIC and for DHs of > or =48 h.

Clinical risk associated with appointment noncompliance in heart transplant recipients.

This study examined the prevalence of appointment noncompliance in 101 heart transplant recipients and how appointment noncompliance is related to patient profile and clinical risk. Appointment noncompliance was defined as patients not showing up at 1 or more planned clinic appointments (at a minimal frequency of every 3 months) during the previous year. Clinical variables were collected from medical files. Psychosocial variables were measured using established instruments. Medication noncompliance was assessed using electronic event monitoring. Paired t test, Wilcoxon 2-sample test, chi-square test, or Fisher exact test were used for statistical analysis as appropriate. The prevalence of appointment noncompliance was 7%. Appointment noncompliers were significantly younger, were less likely to live in a stable relationship with a partner, were more depressed, perceived their health as poorer, experienced more symptom distress, and had significantly more drug holidays. Fifty-seven percent of the appointment noncompliers experienced 1 or more late acute rejection episodes, compared to 2% of the appointment compliers. Appointment noncompliance is a critical behavioral risk factor in the occurrence of late acute rejection episodes in heart transplant patients. Patient profiles allow the identification of patients at risk for appointment noncompliance.

Clinical risk associated with appointment noncompliance in heart transplant recipients

This study examined the prevalence of appointment noncompliance in 101 heart transplant recipients and how appointment noncompliance is related to patient profile and clinical risk. Appointment noncompliance was defined as patients not showing up at 1 or more planned clinic appointments (at a minimal frequency of every 3 months) during the previous year. Clinical variables were collected from medical files. Psychosocial variables were measured using established instruments. Medication noncompliance was assessed using electronic event monitoring. Paired t test, Wilcoxon 2-sample test, chi-square test, or Fisher exact test were used for statistical analysis as appropriate. The prevalence of appointment noncompliance was 7%. Appointment noncompliers were significantly younger, were less likely to live in a stable relationship with a partner, were more depressed, perceived their health as poorer, experienced more symptom distress, and had significantly more drug holidays. Fifty-seven percent of the appointment noncompliers experienced 1 or more late acute rejection episodes, compared to 2% of the appointment compliers. Appointment noncompliance is a critical behavioral risk factor in the occurrence of late acute rejection episodes in heart transplant patients. Patient profiles allow the identification of patients at risk for appointment noncompliance.