Specific Adherence Research Articles

Abstract B007: Racial/ethnic and socioeconomic disparities in over- and under-screening of cervical cancer among a national sample of commercially insured individuals

Abstract In the United States (US), disparities in cervical cancer screening uptake persist by race/ethnicity and socioeconomic status (SES). However, few have examined how race/ethnicity and SES contribute to specific guideline adherence patterns, which can exacerbate existing disparities. We investigated the impact of race/ethnicity and SES (education and household net worth [HHN]) on the probability of over- and under-screening. Optum Clinformatics Data Mart from 2012-2021 was used to identify average-risk females aged 30-64 and ≥1 cervical cancer screening with continuous health plan enrollment and no history of hysterectomy/cervical cancer. Over- and under-screening were defined as intervals between the index and subsequent screening which were shorter and longer than the interval recommended by the 2012 US Preventive Services Task Force guideline, respectively. Multivariate logistic regression was used to evaluate the association of race/ethnicity (Non-Hispanic [NH]-White, NH-Asian, Hispanic, NH-Black) and SES including HHN (<$250,000, $250,000-$500,000, >$500,000) and education level (<Bachelor’s Degree, >Bachelor’s Degree) with over- and under-screening. We tested for interactions between race/ethnicity and SES. Of the 686,884 eligible patients, 72.8% were NH-White, 71.4% had <Bachelor's Degree and 43.3% had HHN <$250,000. Only 7.2% were guideline adherent, 30.7% were under-screened, and 62.1% were over-screened. After regression adjustment, the odds of under-screening were higher among NH-Asian (OR, 1.2; 95%CI, 1.1- 1.2), NH-Black (OR, 1.1; 95%CI, 1.0-1.1), and Hispanic (OR, 1.2; 95%CI, 1.1-1.2) vs NH-White, <Bachelor’s degree (OR, 1.1; 95%CI, 1.0-1.1) vs >Bachelor’s degree, and HHN <$250,000 (OR, 1.3 95%CI, 1.2-1.3) and $250,000-$499,000 (OR, 1.1; 95%CI, 1.0-1.1) vs >$500,000. Odds of over-screening were higher among NH-Black (OR, 1.3; 95%CI, 1.2-1.3), and Hispanic (OR, 1.2; 95%CI, 1.1-1.2) vs NH-White, and lower among <Bachelor’s degree (OR, 0.9; 95%CI, 0.8-0.9) vs >Bachelor’s degree, and HHN <$250,000 (OR, 0.9; 95%CI, 0.9-1.0) and $250,000-$499,000 (OR, 0.9; 95%CI, 0.9-1.0) vs >$500,000. For under-screening, the interaction between race/ethnicity and HHN was significant, and the predicted probability (PP) increased with higher HHN among Hispanic but not in other groups (p<0.01). For over-screening, the interaction between race/ethnicity and HHN was significant and the PP increased with higher HHN among Hispanic and NH-White but decreased for NH-Black and NH-Asian. The interaction between race/ethnicity and education was significant and the PP increased with higher education among Hispanic and NH-White but decreased among NH-Black and NH-Asian. Even within a commercially insured population, we observed that the majority of patients received non-guideline adherent screening and SES contributed to disparities differently among racial/ethnic groups. Findings indicate the need to tailor interventions and policies for subpopulations experiencing over- and under-screening to address the overall screening quality and disparities in outcomes. Citation Format: Michelle B. Shin, Sarah Axeen, Jennifer Tsui. Racial/ethnic and socioeconomic disparities in over- and under-screening of cervical cancer among a national sample of commercially insured individuals [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B007.

Is the NHS low-calorie diet programme delivered as planned? An observational study examining adherence of intervention delivery to service specification.

Obesity and Type 2 Diabetes Mellitus (T2DM) are chronic conditions with significant personal, societal, and economic impacts. Expanding on existing trial evidence, the NHS piloted a 52-week low-calorie diet programme for T2DM, delivered by private providers using total diet replacement products and behaviour change support. This study aimed to determine the extent to which providers and coaches adhered to the service specification outlined by NHS England. An observational qualitative study was conducted to examine the delivery of both one-to-one and group-based delivery of programme sessions. Observations of 122 sessions across eight programme delivery samples and two service providers were completed. Adherence to the service specification was stronger for those outcomes that were easily measurable, such as weight and blood glucose, while less tangible elements of the specification, such as empowering service users, and person-centred delivery were less consistently observed. One-to-one sessions were more successful in their person-centred delivery, and the skills of the coaches delivering the sessions had a strong impact on adherence to the specification. Overall, the results show that there was variability by provider and delivery mode in the extent to which sessions of the NHS Low-Calorie Diet Programme reflected the intended service specification. In subsequent programmes it is recommended that one-to-one sessions are used, with accompanying peer support, and that providers improve standardised training and quality assurance to ensure specification adherence.

Treatment outcome of the tyrosine kinase inhibitor (bosutinib) in previously treated chronic myeloid leukemia patients (sample of Iraqi patients)

Abstract: BACKGROUND: Chronic myeloid leukemia (CML) is a type of myeloproliferative neoplasm characterized by the excessive accumulation of malignant myeloid cells in the bone marrow and peripheral blood. This condition is primarily triggered by a specific chromosomal translocation known as t(9;22) (q34.13;q11.23), which leads to the formation of the BCR-ABL fusion gene. The treatment landscape for CML has undergone significant changes with the approval of tyrosine kinase inhibitors (TKIs) targeting the BCR-ABL1 kinase activity. One such inhibitor is bosutinib, which has been available for several years to treat patients with chronic, accelerated, and blast-phase CML who have shown resistance or intolerance to previous therapies. OBJECTIVES: The aim of this study was to assess efficacy and safety of Bosutinib as a 2nd line therapy in CML patients, in addition to effect of adherence to treatment on patients response. PATIENTS AND METHODS: Eighty-five patients with CML were enrolled in a prospective cohort study from October 2021 to October 2022 at Hematology Center in Medical City Complex – Baghdad. All patients failed to at least one TKI, and all of them started escalated dose of bosutinib. The patients were followed-up by assessing molecular and cytogenetic response at 3 and 6 months and monitored carefully for adverse events (AEs) which were graded by common terminology IX criteria for AEs version 5. Adherence to bosutinib was also monitored by a specific adherence scale to optimize the response rate to treatment. RESULTS: The mean age of patients was 47.3 ± 14.9 (range: 18–77), with male:female ratio 1.4:1. Status of CML patients showed that 89.4% were in the chronic phase, 5.8% in accelerated phase, and 4.7% in blast phase. Regarding the number of previous TKIs before bosutinib, 72.9% of patients failed to prior one TKI (imatinib). At 6 months (72.3%), patients achieve optimal response according to European Leukemia Net criteria 2013. Gastrointestinal symptoms and dermatological manifestations were the most common nonhematological AEs of bosutinib. According to 9-item Morisky Medication Adherence Scale, 42% of patients were adherent to medication which showed a significant association with a higher number of optimal response (P = 0.0001). CONCLUSION: Bosutinib is effective with a high and promising response as a subsequent line treatment in CML patients, and it is generally safe and associated with mild-to-moderate tolerable and manageable AEs. Adherence to the drug plays a significant role in optimal response to bosutinib.

Intersecting risk factors for physical inactivity among Canadian adults.

On average, 45% of Canadian adults meet the recommended 150 minutes per week of moderate-to-vigorous physical activity. This singular statistic masks a wide range of adherence levels among different groups within the population. The purpose of this paper is to determine how sex, age, and family arrangement intersect with known risk factors for physical inactivity to identify groups within the Canadian population most at risk of not meeting the physical activity recommendation. Using six combined cycles of the Canadian Health Measures Survey (from 2007 to 2019), this study examines how the percentage of Canadian males and females aged 18 to 79 years meeting the physical activity recommendation differs across sociodemographic, family arrangement, and health factors. Logistic regression was used to examine whether the association between specific factors and adherence to the physical activity recommendation differed by sex. Latent class analysis was used to identify sex-specific combinations of sociodemographic, family arrangement and health-related factors within the Canadian population that are associated with varying levels of adherence to the physical activity recommendation. More males met the physical activity recommendation compared with females (49% versus 38%). Latent classes with the lowest adherence to the physical activity recommendation (19% among females and 29% among males) primarily included those who were single or married with no children and who had a high probability of having many risk factors for physical inactivity, including being older, having a lower education, having lower income, smoking, having central adiposity, and having poor or fair self-rated general health. Latent classes with the highest adherence to the physical activity recommendation (61% among females and 67% among males) primarily included individuals with no spouse and no children and who had a low probability of having any risk factors for physical inactivity. For females, an additional class (32% of which met the physical activity recommendation) comprised young single mothers who had several risk factors for physical inactivity, including having low income, smoking and having central adiposity. Understanding how risk factors for physical inactivity intersect with sex, age, and family arrangement may inform strategies aimed at increasing physical activity among those who are most vulnerable.

Protocol of a patient randomized clinical trial to improve medication adherence in primary care

BackgroundEnhanced awareness of poor medication adherence could improve patient care. This article describes the original and adapted protocols of a randomized trial to improve medication adherence for cardiometabolic conditions. MethodsThe original protocol entailed a cluster randomized trial of 28 primary care clinics allocated to either (i) medication adherence enhanced chronic disease care clinical decision support (eCDC-CDS) integrated within the electronic health record (EHR) or (ii) usual care (non-enhanced CDC-CDS). Enhancements comprised (a) electronic interfaces printed for patients and clinicians at primary care encounters that encouraged discussion about specific medication adherence issues that were identified, and (b) pharmacist phone outreach. Study subjects were individuals who at an index visit were aged 18–74 years and not at evidence-based care goals for hypertension (HTN), diabetes mellitus (DM), or lipid management, along with low medication adherence (proportion of days covered [PDC] <80%) for a corresponding medication. The primary study outcomes were improved medication adherence and clinical outcomes (BP and A1C) at 12 months.Protocol adaptation became imperative in response to major implementation challenges: (a) the availability of EHR system-wide PDC calculations that superseded our ability to limit PDC adherence information solely to intervention clinics; (b) the unforeseen closure of pharmacies committed to conducting the pharmacist outreach; and (c) disruptions and clinic closures due to the Covid-19 pandemic. ConclusionThis manuscript details the protocol of a study to assess whether enhanced awareness of medication adherence issues in primary care settings could improve patient outcomes. The need for protocol adaptation arose in response to multiple implementation challenges.

Abstract 18787: Rural Intervention for Caregivers’ Heart Health: A Randomized Controlled Trial

Background: Informal caregivers are at greater risk for cardiovascular disease (CVD) than non-caregivers. This risk is higher for older caregivers who often have chronic illnesses, especially those living in a rural environment. Yet caregivers, particularly rural caregivers, are usually “hidden patients” in a caregiver-patient dyad as they commonly ignore their own health. We developed a CVD-risk reduction intervention (RICHH) that promoted self-care in the context of the demands of caregiving. Our aims were to test the impact of RICHH on adherence to CVD risk reduction behaviors and to determine whether age moderated intervention effects on outcomes. Methods: Rural informal caregivers (N=311; 76% female, age=55±14 years) at CVD risk were randomized to intervention or usual care groups. The intervention group completed a 12-week self-care intervention using video conferencing. Outcomes were assessed at 4 and 12 months. Adherence to CVD risk reduction behaviors and adherence to healthy diet was assessed using the Medical Outcome Scale-CVD Specific Adherence Scale and the Healthy Eating Index-2015 (HEI). Piecewise linear mixed-effect modeling determined intervention effects and age moderation. Results: Compared to the usual care group, adherence to CVD risk reduction behaviors increased in intervention at 4 months (b = 2.02, p &lt; 0.001), and the improvement was maintained at 12 months (b = 4.17, p &lt; 0.001; Figure). Total diet quality was improved in intervention versus control at 4-months (b = 0.95, p &lt; 0.001) and was maintained at 12 months (b = 3.05, p = 0.024). Consumption of fruits, vegetables, and whole grains increased in intervention, while intake of sugar and saturated fats decreased. Age did not moderate intervention effects. Conclusion: The intervention was effective in improving adherence to CVD risk reduction behaviors, including heart-healthy eating, regardless of caregiver age, showing its effectiveness for all ages of caregivers.

Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women

Most human immunodeficiency virus (HIV) infections occur in cisgender women in resource-limited settings. In women, self-protection with emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis (FTC/TDF-PrEP) constitutes a major pillar of HIV prevention. However, clinical trials in women had inconsistent outcomes, sparking uncertainty about adherence requirements and reluctance in evaluating on-demand regimens. We analyzed data from published FTC/TDF-PrEP trials to establish efficacy ranges in cisgender women. In a ‘bottom-up’ approach, we modeled hypotheses in the context of risk-group-specific, adherence–efficacy profiles and challenged those hypotheses with clinical data. We found that different clinical outcomes were related to the proportion of women taking the product, allowing coherent interpretation of the data. Our analysis showed that 90% protection was achieved when women took some product. We found that hypotheses of putative male/female differences were either not impactful or statistically inconsistent with clinical data. We propose that differing clinical outcomes could arise from pill-taking behavior rather than biological factors driving specific adherence requirements in cisgender women.

Hearing Aids and Quality of Life: A Psychological Perspective.

This research assessed the relationship between hearing aid usage and quality of life in individuals with hearing impairment, exploring associated demographic and clinical factors. Data from 500 individuals at a tertiary care facility were collected over a year through medical records and an online questionnaire. Quality of life was gauged using WHOQOL-BREF and HHIE. Multiple linear regression analysed the correlation between hearing aid usage and quality of life, adjusting for age, gender, hearing loss severity, and socioeconomic factors. Descriptive statistics showed varying degrees of hearing impairment, socioeconomic status, hearing aid usage, and quality-of-life scores. Bivariate analyses found significant correlations between hearing impairment level, socioeconomic status, hearing aid usage, and quality of life. Linear regression highlighted a positive relationship between daily hearing aid usage duration and quality-of-life scores, even after adjusting for covariates. Variations in quality-of-life ratings were observed between hearing aid users and non-users, spanning different hearing loss levels and socioeconomic statuses. Subgroup analysis showed a positive correlation between hearing aid use and quality of life across age groups. The study confirms the positive influence of hearing aids on the quality of life in hearing-impaired individuals, emphasizing the benefits of consistent use. Further studies should probe the specific domains and long-term adherence impacts. The online version contains supplementary material available at 10.1007/s12070-023-04297-w.

Assessment of adherence to routine vaccination schedules in oncology patients.

Patients diagnosed with cancer are at an increased risk of infection. Vaccines remain one of the most critical public health strategies in limiting infectious diseases, with a heightened importance in cancer patients. Data across the general US population indicates that vaccine adherence rates are suboptimal across all adult vaccine schedules. This study aims to define vaccine adherence rates within the oncology population. This retrospective cohort study includes adult patients with a new cancer diagnosis. Vaccine administrations for COVID-19 (SARS-CoV-2), influenza, pneumococcal, tetanus/diphtheria/pertussis (TDaP), herpes zoster (RZV), human papillomavirus (HPV), and hepatitis B (hepB) were assessed. The primary outcome was complete vaccine adherence. Two hundred and eighty-three oncology patients were included. The median age at diagnosis was 63 years old, and most subjects were females (60%). The two most common malignancies were gastrointestinal and breast cancer at 26.5% and 15.2%, respectively. Suboptimal vaccine adherence rates were observed across the entire oncology population. Complete adherence was observed in only 1.4% of patients. Vaccine specific adherence rates were as follows, SARS-CoV-2: 38.9%; influenza: 11.4%; pneumococcal: 12.7%; TDaP: 13.1%; RZV: 3.5%; HPV: 0%; and hepB: 34%. Among the vaccine schedules assessed, SARS-CoV-2 vaccination rates were the highest with 38.9% of patients being fully adherent and 73% receiving at least one dose. Lower vaccine adherence rates were observed in oncology patients compared to currently published rates. Providers and pharmacists can play a role in assessing and counseling patients on the importance of vaccine adherence before chemotherapy is initiated and after a remission is obtained.

Understanding ART Adherence among Adolescent Girls and Young Women in Western Kenya: A Cross-Sectional Study of Barriers and Facilitators.

HIV remains a leading cause of death for adolescent girls and young women (AGYW) in sub-Saharan Africa. This population has a high incidence of HIV and other comorbidities, such as experiencing violence, and low antiretroviral therapy (ART) adherence. To reach global HIV goals, data are needed on the specific adherence barriers for AGYW living with HIV, so interventions can be targeted effectively. Cross-sectional data were collected at urban and rural health facilities in and around Kisumu County, western Kenya, from January to June 2022, from AGYW 15-24 years of age who were living with HIV. Surveys included questions on intimate partner violence, mental health issues, food security, and orphanhood. Adherence was categorized using viral load testing where available and the Center for Adherence Support Evaluation (CASE) adherence index otherwise. Logistic regression was used to assess associations between potential explanatory variables and adherence. In total, 309 AGYW participated. AGYW with experiences of emotional violence (Odds Ratio [OR] = 1.94, 95% Confidence Interval [CI] = 1.03-3.66), moderate or severe depression (OR = 3.19, 95% CI = 1.47-6.94), and/or substance use (OR = 2.71, 95% CI = 1.24-5.92) had significantly higher odds of poor adherence when compared to AGYW without these respective experiences. Physical and sexual violence, food insecurity, and orphanhood were not associated with poor adherence in this cohort. Elucidating the risk factors associated with poor adherence among AGYW living with HIV allows us to identify potential targets for future interventions to improve ART adherence and HIV care outcomes. Mental health and violence prevention interventions, including combination interventions, may prove to be promising approaches.

SPESİFİK OLMAYAN BEL AĞRILI HASTALARDA TERAPÖTİK EGZERSİZLERE OLAN UYUM

Purpose: Adherence to therapeutic exercises for low back pain can significantly impact longevity, quality of life, and health care costs. There is insufficient research describing the nature and relationship between specific patient characteristics and exercise adherence in non-specific low back pain (NSLBP). This research aimed to examine: (i) the relationship between education and adherence, (ii) the relationship between perceived pain level and adherence, and (iii) whether education and pain level are significant predictors of adherence. &#x0D; Methods: Observational analytic research was conducted in a physiotherapy outpatient setting on a sample of 50 subjects with NSLBP. Data collected were: sociodemographic, pain level according to the visual analogue scale (VAS) and adherence measured by the Exercise Adherence Rating Scale (EARS). For hypotheses testing, statistical methods used were; t-test for small independent samples (i), Pearson correlation coefficient (ii) and linear regression analysis (iii). &#x0D; Results: The results show that: (i) people with a college education are more adherent, (ii) increasing adherence reduces pain level, and (iii) education and pain level are significant in predicting adherence, where education is a stronger predictor. &#x0D; Conclusion: College-educated persons are more prone to therapeutic exercise, and adherence determines physiotherapy outcomes. The contribution of research to clinical practice is reflected in the findings of the nature and relationship between education level and exercise adherence in NSLBP and its significant impact on physiotherapy outcomes.

Anticoagulation in older patients

Prescribing oral anticoagulation in older patients for e.g. stroke prophylaxis has proven to be beneficial, but some special risks have to be considered. Renal function may be substantial impaired and dose reduction in at least some of the substances is recommended. Therefore, a closer monitoring of renal function is essential. Further as bleeding risk also increases with age usual scoring lists do less help this therapeutic dilemma than in younger patients. Adequate blood pressure control is essential in preventing intracerebral hemorrhage. Fall risk has to be assessed to initiate early compensation for this risk. Only high and unimprovable fall incidence may outweigh the benefits of oral anticoagulation therapy (>1 hospital admission per month due to a fall incident). Comprehensive geriatric assessment is crucial for early detection of specific adherence problems in older patients and is also helpful for discussion of individual deprescribing options in an end of live situation.

Prescription auditing and assessment of medication adherence patterns in patients with diabetic foot ulcer.

Diabetic foot ulcer (DFU) is a serious infectious disease, which can be managed very well through proper medication, but if left untreated it may lead to amputation of the affected area leading to permanent immobility which will compromise the patient's quality of life. To carry out prescription auditing and to assess medication adherence patterns among DFUpatients. A prospective interview-based study was carried out in the surgery department among inpatients aged above 18 years diagnosed with a DFU. A disease specific medication adherence questionnaire consisting of 15 questions was developed, validated and implemented among 65 patients. All the relevant data were analyzed and subjected to statistical analysis. The majority (49.2%) of the population had an intermediate adherence pattern followed by high adherence (43%) during the first visit, later the reassessment after the counseling, reports a gradual increase in adherence pattern. Prescription auditing reveals the intensity of drug burden, on anaverage a prescription might carry 8 drugs and more than 95.3% of prescribed drugs were in injectable form. This study highlights the depth of drug burden through prescription auditing and the necessity of proper patient counseling and educating the patient about the importance of medication adherence for limiting disease progression.

Not as simple as it seems: Extensive facility and training gaps in nursing home bathing

Background: Existing training for resident bathing in nursing homes (NHs) is brief and limited, likely because bathing is assumed to be intuitive. However, residents have complex skin issues, devices, dressings, and limited ability for self-care. We sought to assess bathing quality and to identify barriers to proper bathing techniques. Methods: We conducted a prospective observational study of bathing in 8 NHs in Orange County, California, involving a convenience sample of observed bed baths and showers conducted for quality improvement. NH staff were told that observation was occurring, and no feedback was given during or after bathing. Survey elements included cleansing of 6 specific body sites and adherence to bathing procedures (11 for bed baths and 17 for showers). Surveys also included queries to staff to further assess knowledge and perceived barriers. Observed lapses were documented, along with observer-determined reasons for noncompliance (ie, training issue, time pressure, facility issue (insufficient water temperature), resident refusal/behavior). Frequency of noncompliance with each element was tabulated for bed-baths and showers separately. Reasons for failure were displayed graphically. Results: In total, 50 bed baths (NH range, 5–8) and 50 showers (NH range, 4–7) were observed across 8 NHs. Lapses in bathing quality and process were extremely common for both bed baths and showers (Fig.). Inadequate body cleansing occurred for all observed body sites (88%–100% failure for bed baths, 58%–100% failure for showers). Most body areas were either skipped or sprayed with water without soaping. Procedural failures were high for both bed baths and showers (insufficient lather: 100% for bed bath and 40% for shower) lack of firm massage for cleaning (94% for bed bath and 90% for shower), failure to change wipes or cloths when dirty (100% for bed bath and 96% for shower), failure to follow clean-to-dirty sequence (100% for bed bath and 96% shower). In addition, failing to wrap or unwrap devices (73%) and failing to towel dry (94%) were common after showering. Reasons for failure were largely based on training or facility shortcomings (eg, insufficient hot water, inflexible showerhead attachment). Also, 86% of residents complained of being cold. Timing constraints and resident combativeness or refusal were rare. Staff-to-staff bathing advice most commonly involved competing for the “better shower” and “bathing early to get hot water.” Conclusions: Knowing how to appropriately bathe NH residents is not intuitive, and current training is brief and insufficient for high-quality resident care. Unacceptably high failures in proper bathing techniques in NHs necessitate re-evaluation of formal training and standardized practices to better cleanse residents. Moreover, common failures in facility processes for ensuring adequate water temperature and showerhead mobility for bathing or showering should be addressed.Disclosures: None

Automatic medication refills to improve glycaemic control among patients with diabetes and low medication adherence

BackgroundMedication adherence impacts health outcomes. Healthcare organisations implementing system-level interventions have potential for greater spread and sustainability than individual-level interventions. Within the integrated US Veterans Health Administration, a multidisciplinary team...

Poor reporting quality of randomized controlled trials comparing treatments of COVID-19-A retrospective cross-sectional study on the first year of publications.

Transparent and complete reporting of randomized controlled trials (RCTs) is essential for critical scientific appraisal of the results. It has been argued whether publications during the COVID-19 pandemic have met reporting standards. In this study, we assessed reporting adherence of RCTs on treatment interventions in COVID-19 patients to the CONSORT checklist and discuss which lessons can be learned to improve reporting in the future. This was a retrospective, cross-sectional study performed at the University Hospital RWTH Aachen, Germany. We conducted a pragmatic systematic literature search in the PubMed database to identify RCTs on treatment interventions in COVID-19 patients in the first year of publications on the topic (March 2020-February 2021). We investigated the adherence of each publication to the CONSORT checklist and assessed the association between specific predictors and percentage adherence in an exploratory multivariable regression model. We analyzed 127 RCTs and found that the median percentage adherence to the CONSORT checklist was 54.3% [IQR 38.9 to 65.7]. In the exploratory multivariable regression model, the impact factor (highest tertile of impact factor compared to lowest tertile ß = 21.77, 95% CI 13.89 to 29.66, p<0.001; middle tertile compared lowest tertile ß = 11.79, 95% CI 5.74 to 17.84, p<0.001)) and authors' referral to the CONSORT statement (ß = 9.29, 95% CI 2.98 to 15.60, p = 0.004) were associated with a higher percentage adherence to the CONSORT checklist. The reporting quality of RCTs on treatment interventions in COVID-19 patients during the first year of publications was poor. Measures to improve reporting quality are urgently needed.

Assessment of Emicizumab Adherence: Psychometrics and Applications of Novel Self-Report Measure Veritas-Nexgen

Background: Patients with severe hemophilia are at risk for musculoskeletal bleeding that can result in arthropathy and disability. Prophylactic treatment of hemophilia prevents bleeding and joint damage and is recommended as the standard of care for persons with severe hemophilia. Non-adherence to a prophylactic regimen can limit treatment effectiveness and result in adverse health outcomes. Emicizumab, a self-administered subcutaneous treatment, is available for prophylactic therapy of persons with hemophilia A with inhibitors and without inhibitors. This therapy is expected to enhance treatment satisfaction and adherence in hemophilia A. Aims: We completed a pilot study on the initial development and preliminary psychometrics of a new self-report adherence scale for emicizumab titled VERITAS-NEXGEN, modeled on the VERITAS-Pro hemophilia clotting factor adherence scale. In this current study, we investigated a broader set of psychometrics supporting this novel measure of emicizumab adherence in a larger sample. We also sought to describe self-reported adherence using this measure in the larger sample of patients with hemophilia. Methods: The VERITAS-NEXGEN scale consisted of five 5-item subscales (dosing, injection, timing, planning, and bleeds) and an aggregate total score. Items were rated on a 1-9 scale (higher values indicate greater adherence), and subscale and total scores were derived as average scores of constituent items. Participants (N=69 males) with factor VIII deficiency from two hemophilia treatment centers and an active prescription for emicizumab for at least four months were then recruited to complete the scale for psychometric analysis and investigation of self-reported adherence. A subset of the participants (N=20) completed a second adherence scale within one month to provide an estimate of test-retest reliability. The adherence scale was validated against two global patient-ratings of adherence: an established 1-10 rating scale of global adherence (global adherence rating; GAR) and a new 1-10 rating scale of familiarity with treatment. Results: Using the VERITAS-NEXGEN scale, total self-reported adherence was high (average total item score of 8.3 on a 1-9 scale; 9% of patients reporting perfect mean adherence scores of 9, and 87% of patients reporting strong mean adherence scores of 7-8). Based on subscale scores, dosing and injection domains (mean scores of 8.6 and 8.7, respectively; 97% of patients reporting scores of 7 or greater) had greater adherence than the timing and planning domains (mean scores of 7.8 and 8.4, respectively; 14% and 7% of patients reporting scores under 7, respectively). Adherence related to Bleeds also was lower than dosing and injections (mean score=8.1; 14% of patients reporting scores under 7). Internal consistency values for the dosing, injection, bleeds, and total scores were excellent (alpha 0.81-0.91), while alpha values for planning (alpha=0.73) and timing (alpha=0.57) fell in a fair to moderate range. Test-retest reliability for all subscales was good (Planning, r=0.61) to excellent (all other subscales and Total r=0.72-0.83). Dosing, injection, planning, and total scores correlated significantly with global ratings of adherence and treatment familiarity. Timing scores also correlated significantly with global ratings of adherence. Conclusions: Results from this study supported the reliability and validity of subscale and total scores from this new emicizumab adherence scale and provide new insights into adherence strengths and weaknesses in a sample of patients with hemophilia. Overall, self-reported emicizumab adherence was excellent in the sample, with 86-97% of the sample reporting strong to excellent adherence depending on adherence domain. In addition to providing a rapid, easy-to-obtain estimate of patient-rated adherence in the clinical setting, this new adherence scale will allow for investigation of specific adherence domains that are most challenging for patients taking emicizumab, allowing for targeted interventions.

Abstract 11836: Lack of Engagement in Physical Activity Predicts All-Cause of Mortality and Rehospitalization in Patients With Heart Failure

Background: Lack of physical activity is associated with a higher risk of mortality and rehospitalization for patients with heart failure (HF). Although exercise is recommended to patients with HF to optimize health, engagement in physical activity (EPA) remains poor due to many barriers. There is limited knowledge about whether EPA is a unique predictor of event-free survival. Purpose: The purpose of this study was to determine whether EPA was an independent predictor of event-free survival in patients with HF controlling for demographic, clinical factors, and depressive symptoms. Method: We included 1135 patients with HF who completed a survey of EPA (Medical Outcomes Study Specific Adherence Scale [MOS-SAS]), depressive symptoms (Patient Health Questionnaire-9), and demographic and clinical characteristics (age, sex, smoking status, body mass index, and NYHA class). They were followed for 2-years. Event-free survival was the composite endpoint of time to all-cause hospitalization or death. Patients were categorized into EPA (stated engaged in physical activity at least once a week) and non-EPA (stated did not engage in physical activity at all) groups using an activity item of the MOS-SAS. Cox regression analysis was used to determine if EPA was an independent predictor of event-free survival. Result: Among patients (mean age = 64 ± 12.7 years, 64% male, 83% white, 44% NYHA class III/IV), 65% engaged in physical activity, while 35% did not. During follow-up, 118 deaths and 385 rehospitalizations occurred. Patients in the non-EPA group were 1.3 times more likely to die or be hospitalized compared with patients in the EPA group (HR =1.255, 95% CI: 1.039 - 1.517). Conclusion: We found that EPA, even at a low level (at least once a week) was beneficial in reducing the risk of mortality and hospitalization events. Innovative interventions should be developed to motivate non-EPA patients to engage in physical activity.

Bedaquiline Adherence Measured by Electronic Dose Monitoring Predicts Clinical Outcomes in the Treatment of Patients With Multidrug-Resistant Tuberculosis and HIV/AIDS.

Novel regimens have revolutionized multidrug-resistant tuberculosis (MDR-TB) treatment; however, medication adherence remains challenging and poorly characterized. We hypothesized that bedaquiline adherence, measured using electronic dose monitoring, would predict MDR-TB treatment outcomes. This is a prospective cohort study conducted in KwaZulu-Natal, South Africa. Adults with MDR-TB and HIV initiating bedaquiline and on antiretroviral therapy (ART) were eligible. Separate electronic dose monitoring devices measured bedaquiline and ART adherence through 6 months, calculated as observed versus expected doses. Whole-genome sequencing was performed to identify bedaquiline resistance-associated variants. From November 2016 through February 2018, 199 participants with MDR-TB and HIV were enrolled and followed up through treatment completion (median 17.2 months interquartile range 12.2-19.6). The median bedaquiline adherence was higher than ART adherence (97 vs. 89%, P < 0.001) but correlated (r2 = 0.68, P < 0.001). High bedaquiline adherence (≥90%) compared with lower adherence was associated with improved end of treatment successful outcome (83.4% vs. 46.3%, P < 0.001), decreased mortality (11.0% vs. 29.6% P = 0.004), and improved retention in care through end of treatment (94.5% vs. 79.6% P = 0.002). Modeling identified a highly significant but linear association between bedaquiline adherence and outcome. On multivariable analysis, bedaquiline adherence was independently associated with mortality and outcome. Bedaquiline resistance-associated variants were seen in 12% (7/57) of sequenced isolates (7% baseline, 5% emergent) with only 28.6% experiencing successful treatment outcome. Bedaquiline adherence through 6 months independently predicted end of MDR-TB treatment outcome, but a specific bedaquiline adherence threshold was not identified. Interventions to optimize bedaquiline adherence are urgently needed to improve MDR-TB HIV treatment outcomes.

Transition to adult services: the current and potential role of the UK hospital pharmacist

PurposeTo explore the current and potential role for UK pharmacists in the transition to adult services for young people with chronic health problems.MethodsUK hospital pharmacists were surveyed using an online...