Adherence to warfarin assessed by electronic pill caps, clinician assessment, and patient reports: results from the IN-RANGE study.
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ABSTRACT:
SUBMITTER: Parker CS
PROVIDER: S-EPMC2219760 | biostudies-other | 2007 Sep
REPOSITORIES: biostudies-other
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Project description:Warfarin is the primary therapy to prevent stroke and venous thromboembolism. Significant periods of nonadherence frequently go unreported by patients and undetected by providers. Currently, no comprehensive screening tool exists to help providers assess the risk of nonadherence at the time of initiation of warfarin therapy.This article reports on a prospective cohort study of adults initiating warfarin therapy at two anticoagulation clinics (university- and Veterans Affairs-affiliated). Nonadherence, defined by failure to record a correct daily pill bottle opening, was measured daily by electronic pill cap monitoring. A multivariable logistic regression model was used to develop a point system to predict daily nonadherence to warfarin.We followed 114 subjects for a median of 141 days. Median nonadherence of the participants was 14.4% (interquartile range [IQR], 5.8-33.8). A point system, based on nine demographic, clinical, and psychosocial factors, distinguished those demonstrating low vs high levels of nonadherence: four points or fewer, median nonadherence 5.8% (IQR, 2.3-14.1); five points, 9.1% (IQR, 5.9-28.6); six points, 14.5% (IQR, 7.1-24.1); seven points, 14.7% (IQR, 7.0-34.7); and eight points or more, 29.3% (IQR, 15.5-41.9). The model produces a c-statistic of 0.66 (95% CI, 0.61-0.71), suggesting modest discriminating ability to predict day-level warfarin nonadherence.Poor adherence to warfarin is common. A screening tool based on nine demographic, clinical, and psychosocial factors, if further validated in other patient populations, may help to identify groups of patients at lower risk for nonadherence so that intensified efforts at increased monitoring and intervention can be focused on higher-risk patients.
| S-EPMC2851552 | biostudies-other
Project description:ObjectivesSuboptimal medication adherence is a serious problem in the treatment of chronic inflammatory diseases. To measure medication adherence, electronic monitoring is regarded as superior to pill count. GLORIA is an ongoing two-year trial on the addition of low-dose (5 mg/d) prednisolone or placebo to standard care in older people (65+ years) with RA. During the entire trial, adherence is measured with electronic caps, and with pill counts. The objective is to describe medication adherence patterns, and to compare the adherence results of the two methods.MethodsThe recorded adherence patterns of patients (blinded for treatment group) were classified according to descriptive categories. The cutoff for good adherence was set at 80% of prescribed pills taken.ResultsTrial inclusion closed in 2018 at 451 patients, but trial follow-up is ongoing; the current dataset contains adherence data of 371 patients. Mean number of recorded 90-day periods per patient was 4 (range 1-8). Based on pill count over all periods, 90% of the patients had good adherence; based on cap data, only 20%. Cap data classified 30% of patients as non-user (<20% of days an opening) and 40% as irregular user (different adherence patterns, in or between periods).ConclusionIn our trial of older people with RA, the majority appeared to be adherent to medication according to pill count. Results from caps conflicted with those of pill counts, with patterns suggesting patients did not use the bottle for daily dispensing, despite specific advice to do so.Trial registrationNCT02585258. ClinicalTrials.gov (https://www.clinicaltrials.gov/).
| S-EPMC8566247 | biostudies-literature
Project description:BackgroundPoor medication adherence contributes to inadequate control of hypertension. However, the value of adherence monitoring is unknown.ObjectiveTo evaluate the impact of monitoring adherence with electronic pill bottles or bidirectional text messaging on improving hypertension control.DesignThree-arm pragmatic randomized controlled trial.PatientsOne hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12 months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit.InterventionsPatients were randomized in a 1:2:2 ratio to receive (1) usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text).Main measuresChange in systolic BP during the final 4-month visit compared with baseline.Key resultsAt the 4-month follow-up visit, mean (SD) change values in systolic blood pressure were - 4.7 (23.4) mmHg in usual care, - 4.3 (21.5) mmHg in the pill bottle arm, and - 4.6 (19.8) mmHg in the text arm. There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93).ConclusionsDespite good measured adherence, neither feedback with electronic pill bottles nor bidirectional text messaging about medication adherence improved blood pressure control. Adherence to prescribed medications was not improved enough to affect BP control or it was not the primary driver of poor control.Trial registrationclinicaltrials.gov (NCT02778542).
| S-EPMC6848522 | biostudies-literature
Project description:BACKGROUND:While buprenorphine/naloxone (B/N) is approved for opioid use disorder treatment, effective delivery of B/N comes with significant challenges. Most notably, many patients do not take medication daily as prescribed; this non-adherence worsens treatment outcomes, increases healthcare costs, and leads to persistent worries of diversion among providers and policymakers. The present study examines the feasibility, usability, and acceptability of MySafeRx-a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing designed to address the challenges of office-based opioid treatment (OBOT) with B/N. METHODS:The MySafeRx platform integrates electronic pill dispensers, text-messaging, and videoconferencing to provide supervised self-administration of medication and daily motivational coaching through an Android app interface. High-risk early adults (18-39 years old) who were enrolled in OBOT with B/N and had documented illicit opioid use in the past month during opioid agonist therapy (n?=?12) participated in a 28-day single-arm observational study of the MySafeRx platform in addition to standard care. RESULTS:Two-thirds of participants who completed the study achieved an average of >?5 days per week of supervised B/N self-administration. Visual confirmation of medication adherence was demonstrated for an average of 72% of study days among all participants. All participants achieved platform technical proficiency within 60 min, reporting good levels of usability and acceptability. Illicit opioid abstinence rates confirmed by urine toxicology increased by 53% during MySafeRx but fell 43% within 3 weeks post-intervention. CONCLUSION:The MySafeRx medication adherence and remote coaching mobile platform is acceptable and can be feasibly implemented in real-world opioid use disorder treatment settings during high-risk periods (i.e., initial stabilization, after illicit opioid lapse), resulting in reduced illicit opioid use; however, the effect did not last after intervention completion, suggesting longer duration or extended taper of program may be needed. ClinicalTrials.Gov NCT02942199 10/24/16 https://clinicaltrials.gov/ct2/show/NCT02942199.
| S-EPMC6154900 | biostudies-literature
Project description:Background: In 2013, the Clinician-Administered PTSD Scale, the golden standard to assess PTSD, was adapted to the DSM-5 (CAPS-5). Objective: This project aimed to develop a clinically relevant Dutch translation of the CAPS-5 and to investigate its psychometric properties. Method: We conducted a stepped translation including Delphi rounds with a crowd of 44 Dutch psychotrauma experts and five senior psychotrauma experts. Using partial crowd-translations, two professional translations and the official Dutch translation of the DSM-5, each senior expert aggregated one independent translation. Consensus was reached plenary. After back-translation, comparison with the original CAPS-5 and field testing, a last round with the senior experts resulted in the final version. After implementation clinicians conducted CAPS-5 interviews with 669 trauma-exposed individuals referred for specialized diagnostic assessment. Reliability of the Dutch CAPS-5 was investigated through internal consistency and interrater reliability analyses, and construct validity through confirmatory factor analysis (CFA). Results: CAPS-5 total severity score showed high internal consistency (? = .90) and interrater reliability (ICC = .98, 95% CI: .94-.99). CAPS-5 diagnosis showed modest interrater reliability (kappa = .59, 95% CI: .20-.98). CFA with alternative PTSD models revealed adequate support for the DSM-5 four-factor model, but a six-factor (Anhedonia) model fit the data best. Conclusions: The Dutch CAPS-5 is a carefully translated instrument with adequate psychometric properties. Current results add to the growing support for more refined (six and seven) factor models for DSM-5 PTSD indicating that the validity and clinical implications of these models should be objective of further research.
| S-EPMC6263102 | biostudies-literature
Project description:BackgroundThe emergency department has been a major focus for the implementation of Australia's national electronic health record, known as My Health Record. However, the association between use of My Health Record in the emergency department setting and patient care is largely unknown. The aim of this study was to explore the perspectives of emergency department clinicians regarding My Health Record use frequency, the benefits of My Health Record use (with a focus on patient care) and the barriers to use.MethodsAll 393 nursing, pharmacy, physician and allied health staff employed within the emergency department at a tertiary metropolitan public hospital in Melbourne were invited to participate in a web-based survey, between 1 May 2021 and 1 December 2021, during the height of the Delta and Omicron Covid-19 outbreaks in Victoria, Australia.ResultsOverall, the survey response rate was 18% (70/393). Approximately half of the sample indicated My Health Record use in the emergency department (n = 39, 56%, confidence interval [CI] 43-68%). The results showed that users typically only engaged with My Health Record less than once per shift (n = 15, 39%, CI 23-55%). Just over half (n = 19/39, 54%, CI 32-65%) of all participants who use My Health Record agreed they could remember a time when My Health Record had been critical to the care of a patient. Overall, clinicians indicated the biggest barrier preventing their use of My Health Record is that they forget to utilise the system.ConclusionThe results suggest that My Health Record has not been adopted as routine practice in the emergency department, by the majority of participants. Close to half of self-identified users of My Health Record do not associate use as being critical to patient care. Instead, My Health Record may only be used in scenarios that clinicians perceive will yield the greatest benefit-which clinicians in this paper suggest is patients with chronic and complex conditions. Further research that explores the predictors to use and consumers most likely to benefit from use is recommended-and strategies to socialise this knowledge and educate clinicians is desperately required.
| S-EPMC9255536 | biostudies-literature
Project description:Objective. To determine if adherence as measured by pill count would show a significant association with serum-based measures of adherence. Methods. Data were obtained from a prenatal vitamin D supplementation trial where subjects were stratified by race and randomized into three dosing groups: 400 (control), 2000, or 4000 IU vitamin D(3)/day. One measurement of adherence was obtained via pill counts remaining compared to a novel definition for adherence using serum 25-hydroxy-vitamin D (25-OH-D) levels (absolute change in 25(OH)D over the study period and the subject's steady-state variation in their 25(OH)D levels). A multivariate logistic regression model examined whether mean percent adherence by pill count was significantly associated with the adherence measure by serum metabolite levels. Results. Subjects' mean percentage of adherence by pill count was not a significant predictor of adherence by serum metabolite levels. This finding was robust across a series of sensitivity analyses. Conclusions. Based on our novel definition of adherence, pill count was not a reliable predictor of adherence to protocol, and calls into question how adherence is measured in clinical research. Our findings have implications regarding the determination of efficacy of medications under study and offer an alternative approach to measuring adherence of long half-life supplements/medications.
| S-EPMC2821652 | biostudies-literature
Project description:ImportanceElectronic health records (EHRs) are considered a potentially significant contributor to clinician burnout.ObjectiveTo describe the association of EHR usage, sex, and work culture with burnout for 3 types of clinicians at an academic medical institution.Design, setting, and participantsThis cross-sectional study of 1310 clinicians at a large tertiary care academic medical center analyzed EHR usage metrics for the month of April 2019 with results from a well-being survey from May 2019. Participants included attending physicians, advanced practice providers (APPs), and house staff from various specialties. Data were analyzed between March 2020 and February 2021.ExposuresClinician demographic characteristics, EHR metadata, and an institution-wide survey.Main outcomes and measuresStudy metrics included clinician demographic data, burnout score, well-being measures, and EHR usage metadata.ResultsOf the 1310 clinicians analyzed, 542 (41.4%) were men (mean [SD] age, 47.3 [11.6] years; 448 [82.7%] White clinicians, 52 [9.6%] Asian clinicians, and 21 [3.9%] Black clinicians) and 768 (58.6%) were women (mean [SD] age, 42.6 [10.3] years; 573 [74.6%] White clinicians, 105 [13.7%] Asian clinicians, and 50 [6.5%] Black clinicians). Women reported more burnout (survey score ≥50: women, 423 [52.0%] vs men, 258 [47.6%]; P = .008) overall. No significant differences in EHR usage were found by sex for multiple metrics of time in the EHR, metrics of volume of clinical encounters, or differences in products of clinical care. Multivariate analysis of burnout revealed that work culture domains were significantly associated with self-reported results for commitment (odds ratio [OR], 0.542; 95% CI, 0.427-0.688; P < .001) and work-life balance (OR, 0.643; 95% CI, 0.559-0.739; P < .001). Clinician sex significantly contributed to burnout, with women having a greater likelihood of burnout compared with men (OR, 1.33; 95% CI, 1.01-1.75; P = .04). An increased number of days spent using the EHR system was associated with less likelihood of burnout (OR, 0.966; 95% CI, 0.937-0.996; P = .03). Overall, EHR metrics accounted for 1.3% of model variance (P = .001) compared with work culture accounting for 17.6% of variance (P < .001).Conclusions and relevanceIn this cross-sectional study, sex-based differences in EHR usage and burnout were found in clinicians. These results also suggest that local work culture factors may contribute more to burnout than metrics of EHR usage.
| S-EPMC8058638 | biostudies-literature
Project description:BackgroundCluster randomized trials (CRTs) present unique methodological and ethical challenges. Researchers conducting systematic reviews of CRTs (e.g., addressing methodological or ethical issues) require efficient electronic search strategies (filters or hedges) to identify trials in electronic databases such as MEDLINE. According to the CONSORT statement extension to CRTs, the clustered design should be clearly identified in titles or abstracts; however, variability in terminology may make electronic identification challenging. Our objectives were to (a) evaluate sensitivity ("recall") and precision of a well-known electronic search strategy ("randomized controlled trial" as publication type) with respect to identifying CRTs, (b) evaluate the feasibility of new search strategies targeted specifically at CRTs, and (c) determine whether CRTs are appropriately identified in titles or abstracts of reports and whether there has been improvement over time.MethodsWe manually examined a wide range of health journals to identify a gold standard set of CRTs. Search strategies were evaluated against the gold standard set, as well as an independent set of CRTs included in previous systematic reviews.ResultsThe existing strategy (randomized controlled trial.pt) is sensitive (93.8%) for identifying CRTs, but has relatively low precision (9%, number needed to read 11); the number needed to read can be halved to 5 (precision 18.4%) by combining with cluster design-related terms using the Boolean operator AND; combining with the Boolean operator OR maximizes sensitivity (99.4%) but would require 28.6 citations read to identify one CRT. Only about 50% of CRTs are clearly identified as cluster randomized in titles or abstracts; approximately 25% can be identified based on the reported units of randomization but are not amenable to electronic searching; the remaining 25% cannot be identified except through manual inspection of the full-text article. The proportion of trials clearly identified has increased from 28% between the years 2000-2003, to 60% between 2004-2007 (absolute increase 32%, 95% CI 17 to 47%).ConclusionsCRTs should include the phrase "cluster randomized trial" in titles or abstracts; this will facilitate more accurate indexing of the publication type by reviewers at the National Library of Medicine, and efficient textword retrieval of the subset employing cluster randomization.
| S-EPMC2833170 | biostudies-literature
Project description:Using a single-pill combination (SPC) for hypertension (HTN) treatment resulted in better adherence and persistence than a free-equivalent combination in previous observational studies. The aim of this study is to confirm superior adherence with a triple-component SPC compared with an equivalent two-pill regimen in a randomized controlled trial (RCT) using a medication event monitoring system (MEMS). This is a multicenter, open-label, RCT. Subjects were persons with HTN whose clinic blood pressure was not adequately controlled (systolic >140 mmHg or diastolic >90 mmHg) with a dual combination. Eligible patients were randomized to either the triple-component SPC (olmesartan/amlodipine/hydrochlorothiazide 20/5/12.5 mg) group or the equivalent two-pill (olmesartan/hydrochlorothiazide 20/12.5 mg + amlodipine 5 mg) group and maintained for 12 weeks. Primary outcomes were the difference in percentage of doses taken (PDT) and percentage of days with the prescribed dose taken correctly (PDTc) between the single- and two-pill therapy groups, calculated from MEMS data. From 8 hospitals, 145 patients with HTN were randomized. The single-pill group had significantly higher PDT and PDTc than the two-pill group: median (25-75 percentile) PDT 95.1 (86.7-100.0) versus 92.1 (73.0-97.3); and PDTc 91.0 (79.4-96.5) versus 88.6 (69.2-96.3%), P = 0.04 for both by the Wilcoxon rank sum test. The single-pill combination of the triple-component antihypertensive regimen showed better adherence than the equivalent two-pill therapy. Reducing pill burden by means of a single-pill combination is an effective strategy for enhancing adherence to multiple-agent antihypertensive therapy. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Previous studies suggested that the use of a single-pill combination (SPC) in hypertension (HTN) treatment produced better adherence and persistence than a free-equivalent combination. However, supportive data are confined to dual-component SPC and came from observational studies using medication possession ratio as an outcome. WHAT QUESTION DID THIS STUDY ADDRESS? The objective of this study is to investigate whether a triple-component SPC improved medication adherence over an equivalent two-pill combination therapy in a randomized controlled trial using medication event monitoring systems. WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? Medication adherence in the SPC group was superior to that of two-pill group, confirming previous findings from observational studies. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? This finding strongly supports the current HTN treatment guideline to prefer SPC with a higher level of evidence.
| S-EPMC8212718 | biostudies-literature