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Background Unintentional non-adherence has been characterized as passively inconsistent medication-taking behavior (forgetfulness or carelessness). Our objectives were to: (1) study the prevalence and predictors of unintentional non-adherence; and (2) explore the interrelationship between intentional and unintentional non-adherence in relation to patients’ medication beliefs. Methods We conducted a cross-sectional survey of adults with asthma, hypertension, diabetes, hyperlipidemia, osteoporosis, or depression from the Harris Interactive Chronic Illness Panel. The analytic sample for this study included 24,017 adults who self-identified themselves as persistent to prescription medications for their index disease. They answered three questions on unintentional non-adherence (forgot, ran out, being careless), 11 questions on intentional non-adherence, and three multi-item scales assessing perceived need for medication (k = 10), perceived medication concerns (k = 6), and perceived medication affordability (k = 4). Logistic regression was used to model predictors of each unintentional non-adherence behavior. Baron and Kenny’s regression approach was used to test the mediational effect of unintentional non-adherence on the relationship between medication beliefs and intentional non-adherence. Bootstrapping was employed to confirm the statistical significance of these results. Results For the index disease, 62% forgot to take a medication, 37% had run out of the medication, and 23% were careless about taking the medication. Common multivariate predictors (p < .001) of the three behaviors were: (1) lower perceived need for medications; (2) more medication affordability problems; (3) worse self-rated health; (4) diabetes or osteoporosis (relative to hypertension); and (5) younger age. Unique statistically-significant predictors of the three behaviors were: (a) ‘forgot to take medications’ - greater concerns about the index medication and male gender; (b) ‘run out of medications’ - non-white race, asthma, and higher number of total prescription medications; (c) ‘being careless’ - greater medication concerns. Mediational tests confirmed the hypothesis that the effect of medication beliefs (perceived need, concerns, and affordability) on intentional non-adherence is mediated through unintentional non-adherence. Conclusions For our study sample, unintentional non-adherence does not appear to be random and is predicted by medication beliefs, chronic disease, and sociodemographics. The data suggests that the importance of unintentional non-adherence may lie in its potential prognostic significance for future intentional non-adherence. Health care providers may consider routinely inquiring about unintentional non-adherence in order to proactively address patients’ suboptimal medication beliefs before they choose to discontinue therapy all together.

Heart failure is rising in prevalence but relatively little is known about the experiences and journey of patients and their caregivers. The goal of this paper is to present the symptom and symptom impact experiences of patients with heart failure and their caregivers. This was a United States-based study wherein in-person focus groups were conducted. Groups were audio recorded, transcribed and a content-analysis approach was used to analyze the data. Ninety participants (64 patients and 26 caregivers) were included in the study. Most patients were female (52.0%) with mean age 59.3 ± 8 years; 55.6% were New York Heart Association Class II. The most commonly reported symptoms were shortness of breath (81.3%), fatigue/tiredness (76.6%), swelling of legs and ankles (57.8%), and trouble sleeping (50.0%). Patients reported reductions in social/family interactions (67.2%), dietary changes (64.1%), and difficulty walking and climbing stairs (56.3%) as the most common adverse disease impacts. Mental-health sequelae were noted as depression and sadness (43.8%), fear of dying (32.8%), and anxiety (32.8%). Caregivers (mean age 55.5 ± 11.2 years and 52.0% female) discussed 33 daily heart failure impacts, with the top three being reductions in social/family interactions (50.0%); being stressed, worried, and fearful (46.2%); and having to monitor their \"patience\" level (42.3%). There are serious unmet needs in HF for both patients and caregivers. More research is needed to better characterize these needs and the impacts of HF along with the development and evaluation of disease management toolkits that can support patients and their caregivers.

Medication non-adherence can result in poor health outcomes. Understanding differences in adherence rates to non-vitamin K oral anticoagulants (NOACs) could guide treatment decisions and improve clinical outcomes among patients with non-valvular atrial fibrillation (NVAF). To compare adherence to rivaroxaban and apixaban among the overall NVAF population and subgroups of prior oral anticoagulant (OAC) users (e.g., multiple comorbidities, non-adherence risk factors). Using healthcare claims from the Truven Health Analytics MarketScan (7/2012-7/2015), adult patients with ≥2 dispensings of rivaroxaban or apixaban ≥ 180 days apart with > 60 days of supply, ≥ 6 months of pre- and post-index eligibility, ≥ 1 atrial fibrillation diagnosis pre- or on the index date, and without valvular involvement were identified. Propensity-score methods adjusting for potential baseline confounders were used to create matched cohorts of rivaroxaban and apixaban patients. Adherence was assessed during the implementation phase using the percentage of patients with proportion of days covered (PDC) ≥0.8 at 6 months. Subgroups of patients with prior OAC use were evaluated; additional subgroups were identified and evaluated by Quan-Charlson Comorbidity index ≥2 and presence of non-adherence risk factors (i.e., mental disorders, stress, isolation, and rheumatoid arthritis). A total of 13,890 NVAF subjects were included in each of the 2 matched cohorts. All baseline characteristics were balanced between cohorts. At 6 months, significantly more rivaroxaban users were adherent to treatment compared to apixaban users (81.8% vs. 78.0%; absolute difference of 3.8%; p<.001). Rivaroxaban users had significantly higher adherence rates in all subgroups examined. Rivaroxaban users had consistently higher adherence rates than apixaban users overall and among all NVAF subgroups examined.

Background To explore the existing evidence of the real-world implementation of patient-reported outcomes (PROs) in oncology clinical practice and address two aims: (1) summarize available evidence of PRO use in clinical practice using a framework based on the International Society for Quality of Life Research (ISOQOL) PRO Implementation Guide; and (2) describe reports of real-world, standardized PRO administration in oncology conducted outside of scope of a research study. Methods A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol was developed to guide the systematic literature review (SLR) that was conducted in MEDLINE and Embase databases. A two step search strategy was implemented including two searches based on previously completed reviews. Studies published from 2006 to 2017 were synthesized using a framework based on the ISOQOL PRO Implementation Guide. Results After screening 4427 abstracts, 36 studies met the eligibility criteria. Most elements of the ISOQOL PRO Implementation Guide were followed. Two notable exceptions were found: 1) providing PRO score interpretation guidelines (39% of studies); and 2) providing patient-management guidance for addressing issues identified by PROs (25% of studies). Of the 22 studies with an intervention component, 19 (86%) reported intervention effects on study outcomes. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) was the most commonly used PRO ( n  = 10, 28%); use of 38 other PRO measures was also reported. Only three studies (8%) reported real-world PRO implementation. Conclusion Reports of real-world PRO implementation are limited. Reports from studies conducted in clinical settings suggest gaps in information on PRO score interpretation and the use of PRO results to inform patient management. Before the promise of practice-based PRO assessment in oncology can be truly realized, investigators need to advance the state-of-the-art of real-time PRO score interpretation as well as developing guidance on how to use PRO insights to drive clinically-meaningful patient-management strategies.

Non-vitamin K antagonist oral anticoagulant medications are increasingly used for stroke prophylaxis in patients with nonvalvular atrial fibrillation (NVAF). This study aimed to compare adherence with rivaroxaban and apixaban among patients with NVAF in routine clinical practice. Using pharmacy and medical claims from Truven Health Analytics MarketScan databases, we identified NVAF patients aged ≥18 years treated with rivaroxaban or apixaban. Baseline demographic and clinical features were balanced using 1:1 propensity score matching. Adherence to therapy was measured at 90 and 180 days post-index date and was defined by the proportion of days covered (PDC) ≥0.80 and PDC ≥0.90. “Gaps in care,” defined as those with 10 or more day gaps in supply, were also evaluated. Between June 2012 and April 2014, 11,477 rivaroxaban and 2992 apixaban users were identified. Baseline characteristics for rivaroxaban and apixaban users were well matched. Relative to apixaban users, rivaroxaban users were more likely to have a PDC ≥0.80 at both 90 days (85.3% vs 79.9%; P < 0.001) and 180 days (75.8% vs 72.2%; P = 0.001). Similar results were observed with PDC ≥0.90. The proportion of patients with at least one 5+ and 10+ day gap in prescriptions was significantly lower in the rivaroxaban versus apixaban cohorts: 54.2% versus 62.4% (P < 0.001) and 40.0% versus 49.2% (P < 0.001), respectively. Adherence to non-vitamin K antagonist oral anticoagulants among NVAF patients is less than ideal, and gaps in treatment are common. Those on once-a-day rivaroxaban had significantly higher adherence and fewer gaps in treatment compared with twice-a-day apixaban. Future studies are needed to explore whether these treatment differences affect comparative patient outcomes.

▪ Abstract  Over the past 30 years, health status assessment methods for adults have proliferated. Numerous generic, disease-specific, and preference-based measures now exist that tap diverse aspects of functioning, well-being, symptom states, and subjective perceptions of health. The evolution of the state of the art in adult health status assessment is reviewed. Applications of these tools in health services research, health policy, and clinical practice are discussed. Recommendations are offered for selecting among the armamentaria of tools. Conceptual and methodological challenges that confront instrument users and developers alike are identified and discussed.

Advances in the measurement of swallowing physiologic parameters have been clinician-driven, as has the development of intervention techniques to modify swallowing pathophysiology. However, a critical element to determining the success of such efforts will be established by the patients themselves. We conceptualized, developed, and validated the SWAL-QOL, a 93-item quality-of-life and quality-of-care outcomes tool for dysphagia researchers and clinicians. With 93 items, the SWAL-QOL was too long for practical and routine use in clinical research and practice. We used an array of psychometric techniques to reduce the 93-item instrument into two patient-centered outcomes tools: (1) the SWAL-QOL, a 44-item tool that assesses ten quality-of-life concepts, and (2) the SWAL-CARE, a 15-item tool that assesses quality of care and patient satisfaction. All scales exhibit excellent internal-consistency reliability and short-term reproducibility. The scales differentiate normal swallowers from patients with oropharyngeal dysphagia and are sensitive to differences in the severity of dysphagia as clinically defined. It is intended that the standardization and publication of the SWAL-QOL and the SWAL-CARE will facilitate their use in clinical research and clinical practice to better understand treatment effectiveness as a critical step toward improving patients' quality of life and quality of care.

ABSTRACT Objective: Non-adherence to oral bisphosphonate medications is a pervasive problem that blunts their potential to prevent fractures. Using multivariate modeling, we assessed the unique contribution of six classes of variables as drivers of non-adherence to bisphosphonates: (1) beliefs about osteoporosis and its prescription drug treatment, (2) ratings of the affordability of the prescription osteoporosis medications, (3) evaluations of the convenience of the bisphosphonate dosing frequency, (4) reports of troublesome side effects, (5) ratings of aspects of the bisphosphonate dosing regimen, and (6) risk factors for fracture. These categories of predictor variables were selected for investigation because they have been suggested by clinical-trial, survey, and observational studies in osteoporosis as reasons for non-adherence among patients taking prescription osteoporosis therapy. Methods: Women aged 45 or older who filled a prescription for an oral bisphosphonate in January or February of 2006 were identified through a dispensing database of 3300 US retail pharmacies. Subjects received a mailed pre-notification letter from the retail pharmacy chain informing them that someone would be calling them to invite them to participate in a telephone survey about osteoporosis medications. Trained interviewers used a standardized telephone script to recruit patients. Our definition of adherence was provisionally based on database records across a 7-month period and then cross-validated using patient self-report during the telephone recruitment. We measured beliefs regarding bisphosphonate effectiveness and safety, osteoporosis health concerns, concerns regarding drug costs, dosing frequency convenience, and experienced side effects using multi-item scales. Data were collected by telephone interview. Bivariate analyses were conducted using χ2 and t-tests, and multivariate analyses were conducted using logistic regression. Results: Of the 3274 women contacted for study participation, 1092 (33%) completed the interview and 1015 had analyzable data. Multivariate analyses showed that those most symptomatic in terms of side effects and those with the most skeptical beliefs in drug effectiveness and drug safety had odds ratios for non-adherence of 6.78 (95% CI 4.67–9.86), 5.70 (95% CI 3.65–8.92), and 2.26 (95% CI 1.49–3.42), respectively. In multivariate models, osteoporosis health concerns, dosing frequency convenience, and concerns regarding medication costs were not statistically associated with non-adherence to bisphosphonate therapy. Conclusions: The experience of troublesome side effects and patient beliefs regarding the effectiveness and safety of oral bisphosphonate medications prescribed for them are strongly associated with bisphosphonate non-adherence. Improving adherence to oral bisphosphonates may require providers to solicit and address patients’ medication beliefs and to proactively address side effects. Limitations of our study include: (1) the study sample is not likely to be a national random sample of bisphosphonate users, and (2) some evidence of non-response bias was observed.

Objective: The aim of this article was to assess the predictive validity of the Adherence Estimator—a 3-item instrument designed to estimate a patient's propensity to adhere to medications prescribed for chronic disease. Methods: The Adherence Estimator was a 3-item part of a larger survey mailed to adults aged ≥40 years who had a qualifying index prescription filled in June 2008. A qualifying prescription was defined as one for a medication indicated for the treatment of 1 of 5 chronic diseases (cardiovascular disease, dyslipidemia [lipid-lowering drugs], diabetes [oral antihyperglycemics], osteoporosis [oral bisphosphonates], or asthma). Outcomes were compared between the adherence risk groups derived from the Adherence Estimator (low risk = score of 0, medium risk = score of 2–7, and high risk = score of 8–36). Treatment persistence over a period of 9 months was measured using pharmacy claims data. The primary outcome was the median proportion of days covered (PDC) by ≥1 medication during the first 9 months after the index fill. Secondary outcomes included adherence to the index medication, defined as PDC dichotomized to ≥0.80 or <0.80; rate of obtaining a second fill within 30 days of the index fill; and medication possession ratio (MPR) for refill adherence. Results: There were 1676 usable responses. Ages ranged from 40 to 88 years, with a mean of 64.6 years. Almost two thirds (1076/1676 [64.2%]) of the sample were female, and 1483/1676 (88.5%) were white. Statistically significant associations for all 3 pairwise comparisons (low vs medium risk, low vs high risk, and medium vs high risk) were observed between the Adherence Estimator risk groups for: (1) median PDC (0.655, 0.598, and 0.484 in the low-, medium-, and high-risk groups, respectively [all, false discovery rate [FDR] <0.05]); (2) PDC categorized (293/711 [41.21%], 200/588 [34.01%], and 105/377 [27.85%] [all, FDR <0.05]); and (3) rate of obtaining a second fill for the index medication within 30 days (489/711 [68.78%], 374/588 [63.61%], and 207/377 [54.91%] [all, FDR <0.05]). The low- and high-risk groups differed from one another on: (1) persistence with the index medication at 9 months (265/711 [37.27%] and 95/377 [25.20%]); (2) persistence with >1 medication at 9 months (291/711 [40.93%] and 108/377 [28.65%]); and (3) obtaining a second fill for any medication within 30 days (501/711 [70.46%] and 219/377 [59.09%]) (all, P < 0.05). The low- and high-risk groups differed significantly from one another in MPR for refill adherence (0.912 vs 0.866). Results observed within diseases mirrored those for the total sample, but with less precision. Conclusion: In the present analysis of the validity of the Adherence Estimator in predicting adherence, baseline propensity to adhere to medications prescribed for chronic diseases was statistically associated with several measures of adherence and persistence, as derived from pharmacy claims data, over a 9-month period.

Our objective was to explore whether adults hold different beliefs about medications to which they persist vs nonpersist and persist vs nonfulfull. We conducted a cross-sectional survey of adults with asthma, hypertension, diabetes, hyperlipidemia, osteoporosis, or other cardiovascular disease from the Harris Interactive Chronic Illness Panel. A quota was set to obtain a sample of respondents who were persistent to a medication for one disease and nonpersistent or nonfulfilling to a medication for a second, different disease. Respondents completed 32 items yielding five multi-item scales: perceived need for medication (k = 12), side-effect concerns (k = 5), medication-safety concerns (k = 5), perceived disease severity (k = 3), and knowledge about the prescribed medication (k = 7). Respondents completed the 32 items twice - once for their persistent medication and a second time for their nonpersistent or nonfulfilling medication. Paired sample t-tests (bivariate) and generalized estimating equations (GEE) models (multivariate) were used to test the study hypotheses. Overall, 178 respondents were sampled for being persistent to one medication and nonpersistent to another, while 48 respondents were persistent to one medication and nonfulfilling to a second. For the medication to which an individual patient was persistent vs nonpersistent, there was significantly higher perceived need, fewer side-effect concerns, higher perceived disease severity, and better knowledge about the medication. For the medication to which an individual patient was persistent vs nonfulfilling, there was significantly higher perceived need, fewer side-effect concerns, and better knowledge about the medication. Individual patients hold different beliefs about medications to which they persist vs nonpersist or nonfulfill. Patients exhibit different medication-taking behaviors for different medications because they weigh the perceived risks and benefits for each medication separately. These results suggest that adherence interventions should be tailored to patients' beliefs about specific medications.