Early Nonadherence Research Articles

M95 - Early Non-Adherence Among Individuals Initiating Low Barrier Buprenorphine Treatment in an Office-Based Setting

M95 - Early Non-Adherence Among Individuals Initiating Low Barrier Buprenorphine Treatment in an Office-Based Setting

Association of High-Deductible Health Plan Enrollment With Spending on and Use of Lenalidomide Therapy Among Commercially Insured Patients With Multiple Myeloma

High-deductible health plans (HDHPs) require high upfront cost-sharing, which has been associated with suboptimal anticancer medication uptake and adherence. Whether HDHP enrollment has limited the affordability and use of lenalidomide therapy among commercially insured patients with multiple myeloma is unknown. To assess the association of HDHP enrollment with out-of-pocket spending on and adherence to lenalidomide therapy. In this cohort study, data were obtained from the IBM MarketScan Commercial Claims and Encounters Database for adults aged 18 to 64 years with multiple myeloma who newly initiated lenalidomide therapy between April 1, 2013, and June 30, 2017. Quantile regression and modified Poisson regression evaluated out-of-pocket spending, and group-based trajectory models and multinomial logistic regression examined patterns of and factors associated with adherence. Analyses were conducted from April to August 2020. High-deductible health plan enrollment in the 3 months before and 6 months after initiation of lenalidomide therapy. Distribution of out-of-pocket spending, the probability of paying more than $100 for the first and any lenalidomide prescription fill, and monthly lenalidomide therapy adherence using the proportion of days covered (≥80%). Of the 3163 commercially insured patients who initiated lenalidomide therapy (median age, 57 years [IQR, 53-60 years for HDHP enrollees and 52-61 years for non-HDHP enrollees]), 328 (10.4%) were enrolled in HDHPs and 1769 (55.9%) were women. Among the highest spenders (95th percentile), HDHP enrollees paid $376 (95% CI, -$28 to $780) and $217 (95% CI, $106-$323) more for their first and any lenalidomide prescription fill, respectively, compared with non-HDHP enrollees in the 6 months after initiation. High-deductible health plan enrollment was also associated with an increased risk of paying more than $100 for the initial (adjusted risk ratio [aRR], 1.30 [95% CI, 1.13-1.50]) and any (aRR, 1.26 [95% CI, 1.12-1.42]) lenalidomide prescription fill. Three adherence trajectory groups were identified: those with high adherence (n = 1273), late nonadherence (n = 1084), and early nonadherence (n = 805). High-deductible health plan enrollment was not associated with adherence group assignment. In this cohort study, HDHP enrollment was associated with higher out-of-pocket spending per lenalidomide prescription fill; however, no statistically significant differences in adherence patterns between HDHP and non-HDHP enrollees were observed. Patient (eg, perceptions of treatment benefits), payer (eg, out-of-pocket maximums), and clinician (eg, counseling patients on disease severity) factors may have limited the potential for nonadherence among commercially insured patients who initiated lenalidomide therapy.

Predicting Medication Nonadherence in Older Adults With Difficult-to-Treat Depression in the IRL-GRey Randomized Controlled Trial

Nonadherence to antidepressants interferes with optimal treatment of late-life depression. This analysis examines clinical and treatment factors predicting medication nonadherence in difficult-to-treat late-life depression. Secondary analysis of data from a clinical trial of antidepressant pharmacotherapy for Major Depressive Disorder in 468 adults aged 60+ years. All participants received venlafaxine XR for 12 weeks. Nonremitters were randomized to augmentation with either aripiprazole or placebo for 12 additional weeks. Medication adherence was assessed 14 times over 24 weeks. The analyses examined sociodemographic, clinical, and treatment factors that may predict antidepressant nonadherence during early (weeks 1-6), late (weeks 7-12), and augmentation (weeks 13--24) treatment. Poor cognitive function and early response were predictive of early nonadherence. Poor cognitive function and prior nonadherence were predictive of late nonadherence. Living alone was associated with nonadherence both late and during augmentation treatment. Future studies should consider the role of early response and cognitive function to improve antidepressant adherence, particularly among older adults who live alone.

Childhood acute lymphoblastic leukemia treatment in an academic hospital in Kenya: Treatment outcomes and health-care providers' perspectives.

Early deaths and treatment nonadherence are major reasons for low childhood acute lymphoblastic leukemia (ALL) survival in low- and middle-income countries. This study assessed treatment outcomes of children presenting with ALL and evaluated perspectives of health-care providers (HCP) on ALL treatment at a Kenyan academic hospital. This was a combined retrospective medical records and cross-sectional questionnaire study. Treatment outcomes of 136 children diagnosed with ALL between 2010 and 2016 were collected. Questionnaires were completed by 245 HCP (response rate, 86%) between September and October 2016. Childhood ALL treatment outcomes were death (30%), progressive or relapsed disease (26%), abandonment (24%), and event-free survival (20%). Of all deaths, 80% were early deaths (prior or during induction), whereas 20% occurred in remission. Probability of event-free survival at three years was 18%. Only 57% of HCP believed childhood ALL can be cured, with more doctors (96%) than other HCP (45%) believing in curability of ALL (P<0.001). The majority of HCP (96%) thought that experienced doctors should put more time and effort into making parents understand the diagnosis and necessity to complete treatment. According to HCP, reasons for protocol nonadherence included parental financial difficulties (94%) and use of alternative treatment (79%). Event-free survival for ALL in Kenya is low. The primary reason for treatment failure is early death from treatment-related complications. More efforts should be directed toward improving supportive care strategies. In the opinion of HCPs, improved communication with parents and supervision of junior staff will improve ALL treatment outcomes.

A cross-diagnostic study of adherence to ecological momentary assessment: Comparisons across study length and daily survey frequency find that early adherence is a potent predictor of study-long adherence

BackgroundEcological momentary assessment (EMA) offers a highly valid strategy to assess everyday functioning in people with severe mental illness. Adherence is generally good, but several questions regarding the impact of study length, daily density of sampling, and symptom severity on adherence remain. MethodsEMA adherence in two separate studies was examined. One sampled participants with schizophrenia (n = 106) and healthy controls (n = 76) 7 times per day for 7 days and the other sampled participants with schizophrenia (n = 104) and participants with bipolar illness (n = 76) 3 times per day for 30 days. Participants were asked where they were, who they were with, what they were doing and how they were feeling in both studies. The impact of rates of very early adherence on eventual adherence was investigated across the samples, and adherence rates were examined for associations with mood state and most common location when answering surveys. ResultsMedian levels of adherence were over 80% across the samples, and the 10th percentile for adherence was approximately 45% of surveys answered. Early adherence predicted study-long adherence quite substantially in every sample. Mood states did not correlate with adherence in the patient samples and being home correlated with adherence in only the bipolar sample.Implications: Adherence was quite high and was not correlated with the length of the study or the density of sampling per study day. There was a tendency for bipolar participants who were more commonly away from home to answer fewer surveys but overall adherence for the bipolar patients was quite high. These data suggest that early nonadherence is a potential predictor of eventual nonadherence and study noncompletion.

Medication Adherence Trajectories: A Systematic Literature Review.

Traditional adherence measures such as proportion of days covered (PDC) and medication possession ratio (MPR) are limited in their ability to explain patient medication adherence over time. Group-based trajectory modeling (GBTM) is a new methodological approach that visually describes the dynamics of long-term medication adherence and classifies adherence behavior into groups. To describe and compare trajectories of medication nonadherence reported in the medical literature, including identifying consistent trends in adherence trajectories and disease and patient characteristics that predict trajectory group membership. A systematic literature review was conducted in April 2020 in PubMed and CINAHL using MeSH terms and key words in appropriate combinations. Citations were screened for relevance using predefined inclusion and exclusion criteria and evaluated according to variables associated with group-based trajectory models. 21 articles met the study criteria and were reviewed. Generally, studies identified 4 to 6 trajectory groups that described longitudinal medication adherence behavior. Most commonly identified trajectories were labeled as (a) consistent, high adherence, (b) declining adherence, (c) early and consistent nonadherence, and (d) initial nonadherence followed by an increase. Several predictors, including socioeconomic status, disease characteristics, and therapy initiation were routinely associated with group membership. This review suggests that adherence trajectories and predictors of specific group membership may be similar across diverse disease states. GBTM describes longitudinal, dynamic patterns of medication adherence that may facilitate the development of targeted interventions to promote adherence. Implications for value-based payment systems are discussed in this review. No outside funding supported this study. The authors have no conflicts of interest to declare.

Adherence and Persistence to Adjuvant Hormonal Therapy in Early-Stage Breast Cancer Patients: A Population-Based Retrospective Cohort Study in Israel

Background: Adjuvant hormonal therapy (HT) has been consistently proven to improve multiple outcomes in early breast cancer yet rates of adherence and persistence are variable. Methods: We retrospectively identified women diagnosed with nonmetastatic breast cancer and initiating HT between January 2000 and December 2007 in a large Israeli health provider. Prescription records including the drug name, date of purchase, and the quantity of pills dispensed were collected. We used Cox proportional hazards and binary logistic models to analyze factors associated with early discontinuation (<5 years) and nonadherence (proportion of days covered, PDC <80%) of HT, respectively. Results: A total of 4,178 women with breast cancer were identified with nearly 95% of patients treated with tamoxifen as the initial HT. Over the 5-year follow-up period, early discontinuation was identified in 955 (23%) patients. The mean PDC was 82.9% (SD 0.004). Younger age and low BMI were both associated with an increased risk of early discontinuation and nonadherence. A history of hypertension was associated with a higher likelihood of both outcomes. Conclusion: Adherence and persistence with HT among Israeli breast cancer survivors are comparable to those in international reports. Interventions are necessary to identify and prevent suboptimal HT adherence.

Untreated Sleep Apnea: An Analysis of Administrative Data to Identify Risk Factors for Early Nonadherence.

Discontinuation of positive airway pressure (PAP) treatment for obstructive sleep apnea (OSA) is widely reported, but research has not adequately addressed nonadherence with diagnostic testing for sleep disorders and initiation of PAP. This study sought to identify drivers of nonadherence with diagnostic sleep testing and PAP treatment initiation among patients preauthorized for these services. This observational cohort study used preauthorization records from a sleep management program and administrative medical claims from a large commercial health insurer. Participants included adults preauthorized for sleep testing and a subset in whom OSA was diagnosed and who were preauthorized for PAP treatment. Outcome measures were nonadherence with diagnostic sleep testing and PAP treatment initiation, identified as lack of a claim for a preauthorized service within 3 months of preauthorization of that service. Risk factors for nonadherence included patient demographics, prescribing factors, signs and symptoms of OSA, comorbidities, and prior health service utilization. Of 51,749 patients preauthorized for diagnostic testing, 23.5% did not undergo testing. Among 19,968 patients preauthorized for PAP treatment, 11.1% did not initiate treatment. Testing and treatment ordered by primary care providers, residence outside the Midwest region, and two or fewer office visits within 6 months before preauthorization were strong predictors of nonadherence. Apnea-hypopnea index score < 30 events/h was also a strong predictor of nonadherence with treatment initiation. This study adds to existing knowledge about risk factors for nonadherence with sleep testing and treatment initiation following preauthorization. Health plans and providers should develop strategies to better engage patients with higher risk of nonadherence.

Executive Function Predicts Antidepressant Treatment Noncompletion in Late-Life Depression

To examine whether executive function (EF) is associated with nonremission and noncompletion of antidepressant pharmacotherapy in older adults with depression. In this prospective study (July 2009 to May 2014), older adults (aged ≥ 60 years; n = 468) with a DSM-IV-defined major depressive episode diagnosed via structured interview received 12 weeks of venlafaxine extended release with the goal of achieving remission. A hypothesis was made that worse baseline EF would predict both nonremission and noncompletion (primary outcomes). Treatment-related factors, including side effects and nonadherence, were also studied. Baseline EF, including response inhibition and set-shifting, was assessed with subtests of the Delis-Kaplan Executive Function System and the semantic fluency subtest of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Attention, immediate memory, delayed memory, visuospatial ability, and global cognition were also assessed with the RBANS. Of 468 participants, 96 (21%) failed to complete the treatment trial, 191 (41%) completed and remitted, and 181 (39%) completed and did not remit. Univariate analyses indicated that some EFs (set-shifting and semantic fluency) and other cognitive variables (attention, immediate memory, visuospatial ability, and global cognition) predicted treatment noncompletion, whereas no cognitive variables predicted nonremission. In a multivariate logistic regression model, semantic fluency (P = .003), comorbid medical burden (P < .001), and early nonadherence (P < .001) were significant predictors of treatment noncompletion. Poorer EF predicted treatment noncompletion. These findings suggest that EFs of initiation and set maintenance (examined by the semantic fluency task) may allow depressed elderly individuals to engage and stay in treatment. Identification of those at risk for noncompletion may help implementation strategies for personalized care. ClinicalTrials.gov identifier: NCT00892047.

Who benefits from fixed‐dose combinations? Two‐year statin adherence trajectories in initiators of combined amlodipine/atorvastatin therapy

We compared statin adherence in individuals initiating combined amlodipine/atorvastatin therapy as a fixed-dose (FDC) or free combination and identified subgroups benefiting most from FDCs. We used a 10% sample of Australian Pharmaceutical Benefits Scheme dispensing data (2005-2015) to identify individuals initiating amlodipine and atorvastatin as an FDC (n=3996) or free combination (n=5434), with or without prior statin dispensing. We measured the proportion of days covered in each 30-day period over 24months and classified patterns of statin adherence using group-based trajectory models. We identified predictors of adherence trajectories using logistic regression. The median age was 71years, and 53% were female. We identified 4 patterns of statin adherence: near-perfect adherence (n=5383), good adherence (n=1893), declining adherence (n=1247), and early nonadherence (n=907). Compared with the free combination, FDC initiators were more likely to have near-perfect adherence if they were previously statin adherent irrespective of amlodipine dose (amlodipine 5mg: OR=1.61, 95% CI 1.38-1.87; amlodipine 10mg: OR=2.39, 95% CI 1.63-3.51) or they were previously statin nonadherent and initiated on the 5 mg amlodipine dose (OR=1.87, 95% CI 1.50-2.32). Statin-naïve individuals initiating on the FDC with 10 mg amlodipine were less likely to have near-perfect adherence (OR=0.60, 95% CI 0.41-0.88) and more likely to have early nonadherence (OR=1.73, 95% CI 1.17-2.55). The amlodipine/atorvastatin FDC was associated with greater statin adherence among prevalent statin users, and individuals who initiated on lower amlodipine doses. The FDCs did not improve adherence in statin-naïve individuals and in some cases resulted in poorer adherence.

Adherence to Depression Treatment in Primary Care

Nonadherence to antidepressant medication is common and leads to poor outcomes. Early nonadherence is especially problematic. To test the effectiveness of a psychosocial intervention to improve early adherence among older patients whose primary care physician newly initiated an antidepressant for depression. The Treatment Initiation and Participation Program (TIP) was offered in a 2-site randomized clinical effectiveness study between January 2011 and December 2014 at primary care practices in New York, New York, and Ann Arbor, Michigan. Analyses began in February 2016. All participants were middle-aged and older adults (aged ≥55 years) who received newly initiated depression treatment by their primary care physician and recruited within 10 days of their prescription. Analyses were intention-to-treat. Participants were randomly assigned to the intervention (TIP) or treatment as usual. Participants in the TIP group identified and addressed barriers to adherence, including stigma, misconceptions, and fears about treatment, before developing a personalized adherence strategy. The Treatment Initiation and Participation Program was delivered in three 30-minute contacts scheduled during a 6-week period just after the antidepressant was prescribed. The primary outcome was self-reported adherence on the Brief Medication Questionnaire, with adequate early adherence defined as taking 80% or more of the prescribed doses at 6 and 12 weeks. The secondary outcome was depression severity. In total, 231 middle-aged and older adults (167 women [72.3%] and 64 men [27.7%]) without significant cognitive impairment were randomly assigned to the TIP intervention (n = 115) or treatment as usual (n = 116). Participants had a mean (SD) age of 67.3 (8.4) years. Participants in the TIP group were 5 times more likely to be adherent at 6 weeks (odds ratio, 5.54; 95% CI, 2.57 to 11.96; χ21 = 19.05; P < .001) and 3 times more likely to be adherent at both 6 and 12 weeks (odds ratio, 3.27; 95% CI, 1.73 to 6.17; χ21 = 13.34; P < .001). Participants in the TIP group showed a significant earlier reduction (24.9%) in depressive symptoms (95% CI, 13.9 to 35.9; t337 = 4.46; adjusted P < .001). In both groups, participants who were 80% adherent at weeks 6 and 12 had a 15% greater improvement in depressive symptoms from baseline over the course of treatment (95% CI, -0.2 to -30; t369 = 1.93; P = .051). The Treatment Initiation and Participation Program is an effective intervention to improve early adherence to pharmacotherapy. Improved adherence can promote improvement in depression. clinicaltrials.gov Identifier: NCT01301859.

Depressive symptoms and adherence to cardiometabolic therapies across phases of treatment among adults with diabetes: the Diabetes Study of Northern California (DISTANCE).

ObjectiveAmong adults with diabetes, depression is associated with poorer adherence to cardiometabolic medications in ongoing users; however, it is unknown whether this extends to early adherence among patients newly prescribed these medications. This study examined whether depressive symptoms among adults with diabetes newly prescribed cardiometabolic medications are associated with early and long-term nonadherence.Patients and methodsAn observational follow-up of 4,018 adults with type 2 diabetes who completed a survey in 2006 and were newly prescribed oral antihyperglycemic, antihypertensive, or lipid-lowering agents within the following year at Kaiser Permanente Northern California was conducted. Depressive symptoms were examined based on Patient Health Questionnaire-8 scores. Pharmacy utilization data were used to identify nonadherence by using validated methods: early nonadherence (medication never dispensed or dispensed once and never refilled) and long-term nonadherence (new prescription medication gap [NPMG]: percentage of time without medication supply). These analyses were conducted in 2016.ResultsPatients with moderate-to-severe depressive symptoms had poorer adherence than nondepressed patients (8.3% more patients with early nonadherence, P=0.01; 4.9% patients with longer NPMG, P=0.002; 7.8% more patients with overall nonadherence [medication gap >20%], P=0.03). After adjustment for confounders, the models remained statistically significant for new NPMG (3.7% difference, P=0.02). There was a graded association between greater depression severity and nonadherence for all the models (test of trend, P<0.05).ConclusionDepressive symptoms were associated with modest differences in early and long-term adherence to newly prescribed cardiometabolic medications in diabetes patients. Interventions targeting adherence among adults with diabetes and depression need to address both initiation and maintenance of medication use.

Endocrine Therapy in Older Women with Early-Stage Hormone Sensitive Breast Cancer

Breast cancer is the most common cancer affecting women worldwide, with the highest risk in those aged 70 and over. Most older women (80% to 85%) have hormone receptor positive breast cancer and thus the use of endocrine therapy is common in this population. Typically, women receive endocrine therapy for at least 5 years to reduce the risk of cancer recurrence and decrease breast-cancer mortality. However, adherence to hormonal therapy may be an issue, particularly in older women, as side effects may lead to early discontinuation and/or non-adherence. Older women on endocrine therapy are often cared for by primary care physicians and geriatricians and therefore, an understanding of oral endocrine therapy, as well as its potential side effects, is essential for treating physicians. This review describes the benefits of endocrine therapy in patients with resected breast cancer, compare different hormonal therapies with regards to side-effects and discuss management strategies with a particular focus on the concerns of older breast cancer patients on endocrine therapy. Mrs. Smith is a 75-year-old woman whose family doctor noted a 3 cm to 4 cm lump in her left breast during a routine physical exam. She has no palpable lymph nodes. Her family doctor sends her for a mammogram which reveals a 2.6 cm spiculated mass in the left upper outer quadrant. Biopsy reveals an invasive ductal carcinoma.

Intraoperative Interface Fluid Dynamics and Clinical Outcomes for Intraoperative Optical Coherence Tomography–Assisted Descemet Stripping Automated Endothelial Keratoplasty From the PIONEER Study

To correlate intraoperative interface fluid dynamics during Descemet stripping automated endothelial keratoplasty (DSAEK) using intraoperative optical coherence tomography (iOCT) in the Prospective Intraoperative and Perioperative Ophthalmic Imaging with Optical Coherence Tomography (PIONEER) study with postoperative outcomes. Prospective consecutive, interventional, comparative case series. One hundred seventy-eight eyes of 173 patients undergoing DSAEK from the Cole Eye Institute, Cleveland, Ohio. Eyes that underwent DSAEK between October 2011 and March 2014 from the PIONEER intraoperative and perioperative OCT study were included. An automated interface fluid segmentation algorithm evaluated intraoperative dynamics of interface fluid before and after surgical manipulations. iOCT images were also captured at multiple intraoperative time points for 2 different DSAEK techniques, 1 that used an active air infusion system and 1 that did not. Interface fluid metrics, graft nonadherence. iOCT measurements of interface fluid after final surgical manipulations and immediately before leaving the operating room identified that total fluid volume (P= .002), largest fluid volume pocket (P= .002), max fluid area (P= .006), mean fluid thickness (P=.03), and max fluid thickness (P= .01) significantly correlated with graft nonadherence rates within the first postoperative week. After placement and optimization of intraoperative lenticle adherence, iOCT revealed a significant difference between the area, volume, and thickness of maximum fluid pockets between the 2 surgical techniques, but both techniques resulted in significant reduction of interface fluid during the procedure. Larger residual interface fluid volume, area, and thickness at the end of surgery detected with iOCT are associated with early graft nonadherence and can be quantified with an automated algorithm. iOCT imaging can successfully capture technique-dependent differences in fluid dynamics during DSAEK.

Medication Nonadherence After Lung Transplantation in Adult Recipients

Our objective was to identify potential avenues for resource allocation and patient advocacy to improve outcomes by evaluating the association between recipient sociodemographic and patient characteristics and medication nonadherence after lung transplantation. States US adult, lung-only transplantations per the United Network for Organ Sharing database were analyzed from October 1996 through December 2006, based on the period during which nonadherence information was recorded. Generalized linear models were used to determine the association of demographic, disease, and transplantation center characteristics with early nonadherence (defined as within the first year after transplantation) as well as late nonadherence (years 2 to 4 after transplantation). Outcomes comparing adherent and nonadherent patients were also evaluated. Patients (n= 7,284) were included for analysis. Early and late nonadherence rates were 3.1% and 10.6%, respectively. Factors associated with early nonadherence were Medicaid insurance compared with private insurance (adjusted odds ratio [AOR] 2.45, 95% confidence interval [CI]: 1.16 to 5.15), and black race (AOR 2.38, 95% CI: 1.08 to 5.25). Medicaid insurance and black race were also associated with late nonadherence (AOR 2.38, 95% CI: 1.51 to 3.73 and OR 1.73, 95% CI: 1.04 to 2.89, respectively), as were age 18 to 20 years (AOR 3.41, 95% CI: 1.29 to 8.99) and grade school or lower education (AOR 1.88, 95% CI: 1.05 to 3.35). Early and late nonadherence were both associated with significantly shorter unadjusted survival (p < 0.001). Identifying patients at risk of nonadherence may enable resource allocation and patient advocacy to improve outcomes.

ANTIDEPRESSANT ADHERENCE ACROSS DIVERSE POPULATIONS AND HEALTHCARE SETTINGS.

Early adherence is key to successful depression treatment, but nearly 60% of patients discontinue antidepressants within 3 months. Our study aimed to determine factors associated with poor early adherence to antidepressants in a large diverse sample of patients. Six Mental Health Research Network healthcare systems contributed data for adults with depression and a new antidepressant start, defined by a washout period of at least 270 days, between January 1, 2010 and December 31, 2012. Pharmacy fill and self-reported race/ethnicity data were obtained from the electronic medical record. Patients had early adherence if they had a second antidepressant fill within 180 days of the first. We used logistic regression to investigate the relationship between early adherence and patient characteristics. A total of 177,469 adult patients had 184,967 new episodes of depression with a filled antidepressant prescription. Patients refilled their antidepressants within 180 days in 71% of episodes. Race/ethnicity was a strong predictor of early adherence, with patients from racial/ethnic minorities other than Native Americans/Alaskan Natives less likely (adjusted odd ratios 0.50-0.59) to refill their antidepressants than non-Hispanic whites. Age, neighborhood education, comorbidity burden, provider type and engagement in psychotherapy were also associated with adherence. Other apparent predictors of early adherence, including neighborhood income, gender, and prior mental health hospitalizations, were no longer significant in the fully adjusted model. Race/ethnicity was a robust predictor of early antidepressant adherence, with minority groups other than Native Americans/Alaskan Natives less likely to be adherent. Further research is needed to determine whether early nonadherence in specific minority populations is intentional, due to side effects or patient preference, or unintentional and appropriate for targeted interventions to improve adherence.

Abstract P5-12-04: Directed exercise intervention in breast cancer patients with arthralgias receiving aromatase inhibitors: A randomized pilot study

Abstract Purpose: Early discontinuation or non-adherence of AI therapy occurs in 25-50 % of patients due to treatment associated toxicities, including musculoskeletal symptoms such as arthralgias and myalgias. The goal of this pilot study is to evaluate the effect of a directed physical therapy regimen including joint mobility and stretching exercises on musculoskeletal symptoms resulting from AI therapy, in comparison to normal physical activity alone. Patients and methods: Eligibility criteria included post-menopausal women with histological evidence of hormone receptor positive breast cancer who were currently receiving adjuvant AI therapy and experiencing significant joint discomfort/stiffness when attempting activities of daily living which began or significantly increased after initiation of AI therapy. Patients were excluded if they had preexisting rheumatoid arthritis or fibromyalgia, systemic metastasis or ECOG performance status of greater than 2. Patients were randomly assigned to an 8 week directed exercise program under the supervision of a physical therapist (Group A, n=15) or were told to participate in moderate physical activity (walking) (Group B, n=12). Before beginning the study and at the end of the 8 week intervention, patients in both groups underwent a physical therapy evaluation including performance based measures such as functional lower extremity strength and grip strength and a Patient Specific Functional Scale (PSFS) to assess functional ability to complete specific activities. Additionally, all patients answered a series of questionnaires including a pain disability index (PDI), pain scale (PS) and the PHQ4 depression scale. Effects of the directed exercise regimen were evaluated using non-parametric analysis to determine differences between the two groups. Results: Significant improvement was observed in both left and right grip strength and right pinch in the intervention group (Group A) as compared to the control group (Group B). Additionally, significant improvement in lower body measures including 2-minute step tests and chair raises were observed in patients who underwent the directed exercise program compared to the control group. No significant differences were observed in PS, PDI or PHQ4 between the groups. However, Group A showed a slight improvement on the PS and PDI. Conclusions: Directed exercise regimens involving joint mobility and stretching exercises may have benefits over moderate physical activity alone for joint pain and arthralgia associated with AI therapy. Citation Format: Varadarajan R, Helm E, Arnold C, Huelsenbeck-Dill L, Ingraham-Lopresto B, Sonaad S, Swanson P, Sims-Mourtada J, Dickson-Whitmer D. Directed exercise intervention in breast cancer patients with arthralgias receiving aromatase inhibitors: A randomized pilot study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-12-04.

Abstract 11913: Early Nonadherence With Dabigatran and Rivaroxaban in Patients With Atrial Fibrillation

Background: Dabigatran and rivaroxaban are novel oral anticoagulants (NOACs) approved recently for stroke prevention in atrial fibrillation (AF). Although NOACs are more convenient than warfarin, their lack of monitoring, and for dabigatran, dosing frequency may predispose patients to nonadherence. Limited information is available on the adherence rates and related clinical outcomes for dabigatran and rivaroxaban in clinical practice. Methods: We conducted a population-based cohort study using administrative data of patients aged 65 years and over with AF, linking hospital discharge abstract and prescription claims databases in Ontario, Canada from April 2012 to March 2014. Nonadherence was measured as proportion of patients discontinuing dabigatran or rivaroxaban, defined as a gap in dabigatran or rivaroxaban prescription for ≥14 days within the first 6 months of therapy, and time to discontinuation. A multivariate Cox proportional hazards model was used to examine the association between drug discontinuation at any time, and the composite outcome of hospitalization for stroke, or death. Results: The cohort consisted of 15,857 dabigatran users and 10,119 rivaroxaban users, with women comprising 52% of each medication group. Mean age was 80.7±6.7 years for dabigatran, and 77.0±7.1 years for rivaroxaban patients. At 6-months, 36.5% of patients discontinued dabigatran (110mg: 37.4%; 150mg: 34.1%), while 32.1% of patients discontinued rivaroxaban. Median time to discontinuation was 240 days (IQR: 78-523) for dabigatran and 140 days (IQR: 52-283) for rivaroxaban. Risk of the composite outcome (stroke or death) was significantly higher for those who discontinued dabigatran [HR 1.78 (95% CI 1.62-1.95);p&lt;0.0001] or discontinued rivaroxaban [HR 3.07 (95% CI 2.54-3.72);p&lt;0.0001] compared with those who did not discontinue the medication. Conclusions: Within 6 months of initiation, discontinuation rates are high in clinical practice, with 1 in 4 patients discontinuing dabigatran, and 1 in 3 patients discontinuing rivaroxaban. There is an association between nonadherence with either dabigatran or rivaroxaban and significantly worse clinical outcomes following medication discontinuation.

Behavioral predictors of medication adherence trajectories among youth with newly diagnosed epilepsy.

This study aimed to identify psychosocial predictors of two-year antiepileptic drug (AED) adherence trajectories among youth with newly diagnosed epilepsy, controlling for known demographic and medical factors. This study is part of a large, prospective, longitudinal observational study of AED adherence and medical outcomes in youth with newly diagnosed epilepsy. Parents completed questionnaires of psychosocial and family functioning at one month and one year following diagnosis. Chart review and questionnaires were used to collect medical variables and seizure outcomes. Previously established two-year AED adherence trajectories (Severe Early Nonadherence, Variable Nonadherence, Moderate Nonadherence, High Adherence) were used as the outcome variable. Participants were 91 parents of youth with epilepsy (7.3±2.8years of age; 60% male) and their families. Early (one month following diagnosis) predictors of two-year adherence trajectories included socioeconomic status, epilepsy knowledge, family problem-solving, and family communication. Significant predictors one year following diagnosis included socioeconomic status, parent fears and concerns, and parent life stress. There are modifiable parent and family variables that predict two-year adherence trajectories above and beyond known medical (e.g., seizures, side effects) factors. Psychosocial interventions delivered at key points during the course of epilepsy treatment could have a positive impact on adherence outcomes.

Early Medication Nonadherence After Acute Myocardial Infarction: Insights into Actionable Opportunities From the TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study.

Nonadherence to prescribed evidence-based medications after acute myocardial infarction (MI) can contribute to worse outcomes and higher costs. We sought to better understand the modifiable factors contributing to early nonadherence of evidence-based medications after acute MI. We assessed 7425 acute MI patients treated with percutaneous coronary intervention at 216 US hospitals participating in TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) between April 2010 and May 2012. Using the validated Morisky instrument to assess cardiovascular medication adherence at 6 weeks post MI, we stratified patients into self-reported high (score, 8), moderate (score, 6-7), and low (score, <6) adherence groups. Moderate and low adherence was reported in 25% and 4% of patients, respectively. One third of low adherence patients described missing doses of antiplatelet therapy at least twice a week after percutaneous coronary intervention. Signs of depression and patient-reported financial hardship because of medication expenses were independently associated with a higher likelihood of medication nonadherence. Patients were more likely to be adherent at 6 weeks if they had follow-up appointments made before discharge and had a provider explain potential side effects of their medications. Lower medication adherence may be associated with a higher risk of 3-month death/readmission (adjusted hazard ratio, 1.35; 95% confidence interval, 0.98-1.87) although this did not reach statistical significance. Even early after MI, a substantial proportion of patients report suboptimal adherence to prescribed medications. Tailored patient education and pre discharge planning may represent actionable opportunities to optimize patient adherence and clinical outcomes. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01088503.