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BackgroundMedication adherence is essential for improving the health outcomes of patients. Various patient-reported outcome measures (PROMs) have been developed to measure medication adherence in patients. However, no study has summarized the psychometric properties of these PROMs to guide selection for use in clinical practice or research. ObjectiveThis study aims to evaluate the quality of the PROMs used to measure medication adherence. MethodsThis study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the EMBASE, PubMed, Cochrane Library, Web of Science, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases. The PROMs were then evaluated based on the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines. ResultsA total of 121 unique medication adherence PROMs from 214 studies were identified. Hypotheses testing for construct validity and internal consistency were the most frequently assessed measurement properties. PROMs with at least a moderate level of evidence for ≥5 measurement properties include the Adherence Starts with Knowledge 20, Compliance Questionnaire-Rheumatology, General Medication Adherence Scale, Hill-Bone Scale, Immunosuppressant Therapy Barrier Scale, Medication Adherence Reasons Scale (MAR-Scale) revised, 5-item Medication Adherence Rating Scale (MARS-5), 9-item MARS (MARS-9), 4-item Morisky Medication Adherence Scale (MMAS-4), 8-item MMAS (MMAS-8), Self-efficacy for Appropriate Medication Adherence Scale, Satisfaction with Iron Chelation Therapy, Test of Adherence to Inhalers, and questionnaire by Voils. The MAR-Scale revised, MMAS-4, and MMAS-8 have been administered electronically. ConclusionsThis study identified 121 PROMs for medication adherence and provided synthesized evidence for the measurement properties of these PROMs. The findings from this study may assist clinicians and researchers in selecting suitable PROMs to assess medication adherence.

BackgroundMedication adherence is important in managing the progression of chronic diseases. A promising approach to reduce cognitive burden when measuring medication adherence lies in the use of computer‐adaptive tests (CATs) or in the development of shorter patient-reported outcome measures (PROMs). However, the lack of an item bank currently hampers this progress. ObjectiveWe aim to develop an item bank to measure general medication adherence. MethodsUsing the preferred reporting items for systematic review and meta-analysis (PRISMA), articles published before October 2019 were retrieved from PubMed, Embase, CINAHL, the Cochrane Library, and Web of Science. Items from existing PROMs were classified and selected (“binned” and “winnowed”) according to standards published by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cooperative Group. ResultsA total of 126 unique PROMs were identified from 213 studies in 48 countries. Items from the literature review (47 PROMs with 579 items for which permission has been obtained) underwent binning and winnowing. This resulted in 421 candidate items (77 extent of adherence and 344 reasons for adherence). ConclusionsWe developed an item bank for measuring general medication adherence using items from validated PROMs. This will allow researchers to create new PROMs from selected items and provide the foundation to develop CATs.

BackgroundHydroxyurea prevents disease complications among patients with sickle cell disease (SCD). Although its efficacy has been endorsed by the National Health Lung and Blood Institute evidence-based guidelines, its adoption is low, both by patients with SCD and providers. Mobile health (mHealth) apps provide benefits in improving medication adherence and self-efficacy among patients with chronic diseases and have facilitated prescription among medical providers. However, mHealth has not been systematically tested as a tool to increase hydroxyurea adherence nor has the combination of mHealth been assessed at both patient and provider levels to increase hydroxyurea utilization. ObjectiveThis study aims to increase hydroxyurea utilization through a combined two-level mHealth intervention for both patients with SCD and their providers with the goals of increasing adherence to hydroxyurea among patients and improve hydroxyurea prescribing behavior among providers. MethodsWe will test the efficacy of 2 mHealth interventions to increase both patient and provider utilization and knowledge of hydroxyurea in 8 clinical sites of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). The patient mHealth intervention, InCharge Health, includes multiple components that address memory, motivation, and knowledge barriers to hydroxyurea use. The provider mHealth intervention, Hydroxyurea Toolbox (HU Toolbox), addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea. The primary hypothesis is that among adolescents and adults with SCD, adherence to hydroxyurea, as measured by the proportion of days covered (the ratio of the number of days the patient is covered by the medication to the number of days in the treatment period), will increase by at least 20% after 24 weeks of receiving the InCharge Health app, compared with their adherence at baseline. As secondary objectives, we will (1) examine the change in health-related quality of life, acute disease complications, perceived health literacy, and perceived self-efficacy in taking hydroxyurea among patients who use InCharge Health and (2) examine potential increases in the awareness of hydroxyurea benefits and risks, appropriate prescribing, and perceived self-efficacy to correctly administer hydroxyurea therapy among SCD providers between baseline and 9 months of using the HU Toolbox app. We will measure the reach, adoption, implementation, and maintenance of both the InCharge Health and the HU Toolbox apps using the reach, effectiveness, adoption, implementation, and maintenance framework and qualitatively evaluate the implementation of both mHealth interventions. ResultsThe study is currently enrolling study participants. Recruitment is anticipated to be completed by mid-2021. ConclusionsIf this two-level intervention, that is, the combined use of InCharge Health and HU Toolbox apps, demonstrates efficacy in increasing adherence to hydroxyurea and prescribing behavior in patients with SCD and their providers, respectively, both apps will be offered to other institutions outside the SCDIC through a future large-scale implementation-effectiveness study. Trial RegistrationClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167 International Registered Report Identifier (IRRID)DERR1-10.2196/16319

Hydroxyurea reduces sickle cell disease (SCD) complications, but medication adherence is low. We tested 2 mobile health (mHealth) interventions targeting determinants of low adherence among patients (InCharge Health) and low prescribing among providers (HU Toolbox) in a multi-center, non-randomized trial of individuals with SCD ages 15-45. We compared the percentage of days covered (PDC), labs, healthcare utilization, and self-reported pain over 24 weeks of intervention and 12 weeks post-study with a 24-week preintervention interval. We enrolled 293 patients (51% male; median age 27.5 years, 86.8% HbSS/HbSβ0-thalassemia). The mean change in PDC among 235 evaluable subjects increased (39.7% to 56.0%; P < 0.001) and sustained (39.7% to 51.4%, P < 0.001). Mean HbF increased (10.95% to 12.78%; P = 0.03). Self-reported pain frequency reduced (3.54 to 3.35 events/year; P = 0.041). InCharge Health was used ≥1 day by 199 of 235 participants (84.7% implementation; median usage: 17% study days; IQR: 4.8-45.8%). For individuals with ≥1 baseline admission for pain, admissions per 24 weeks declined from baseline through 24 weeks (1.97 to 1.48 events/patient, P = 0.0045) and weeks 25-36 (1.25 events/patient, P = 0.0015). PDC increased with app use (P < 0.001), with the greatest effect in those with private insurance (P = 0.0078), older subjects (P = 0.033), and those with lower pain interference (P = 0.0012). Of the 89 providers (49 hematologists, 36 advanced care providers, 4 unreported), only 11.2% used HU Toolbox ≥1/month on average. This use did not affect change in PDC. Tailoring mHealth solutions to address barriers to hydroxyurea adherence can potentially improve adherence and provide clinical benefits. A definitive randomized study is warranted. This trial was registered at www.clinicaltrials.gov as #NCT04080167.

BackgroundUnderstanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies. ObjectiveThis study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement. MethodsThe CITY trial tested two 24-month weight loss interventions. One was delivered with a smartphone app (cell phone) containing 24 components (weight tracking, etc) and included prompting by the app in predetermined frequency and forms. The other was delivered by a coach via monthly calls (personal coaching) supplemented with limited app components (18 overall) and without any prompting by the app. Engagement was assessed by calculating the percentage of days each app component was used and the frequency of use. Engagement was also examined across 4 weight change categories: gained (≥2%), stable (±2%), mild loss (≥2% to

In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

BackgroundThe use of health information technology (HIT) may improve medication adherence, but challenges for implementation remain. ObjectiveThe aim of this paper is to review the current state of HIT as it relates to medication adherence programs, acknowledge the potential barriers in light of current legislation, and provide recommendations to improve ongoing medication adherence strategies through the use of HIT. MethodsWe describe four potential HIT barriers that may impact interoperability and subsequent medication adherence. Legislation in the United States has incentivized the use of HIT to facilitate and enhance medication adherence. The Health Information Technology for Economic and Clinical Health (HITECH) was recently adopted and establishes federal standards for the so-called "meaningful use" of certified electronic health record (EHR) technology that can directly impact medication adherence. ResultsThe four persistent HIT barriers to medication adherence include (1) underdevelopment of data reciprocity across clinical, community, and home settings, limiting the capture of data necessary for clinical care; (2) inconsistent data definitions and lack of harmonization of patient-focused data standards, making existing data difficult to use for patient-centered outcomes research; (3) inability to effectively use the national drug code information from the various electronic health record and claims datasets for adherence purposes; and (4) lack of data capture for medication management interventions, such as medication management therapy (MTM) in the EHR. Potential recommendations to address these issues are discussed. ConclusionTo make meaningful, high quality data accessible, and subsequently improve medication adherence, these challenges will need to be addressed to fully reach the potential of HIT in impacting one of our largest public health issues.

While older adults account for a disproportionate amount of healthcare spending, they are often underrepresented in clinical research needed to guide clinical care. The purpose of this perspective is to make readers aware of new data on age at enrollment for participants included in National Institutes of Health (NIH)-funded clinical research. We highlight key findings of relevance to general internal medicine and suggest ways readers could support the inclusion of older adults in clinical research. Data from the NIH Research Inclusion Statistics Report show that there were 881,385 participants enrolled in all NIH-funded clinical research in 2021, of whom 170,110 (19%) were 65 years and older. However, on average, studies included a far lower percentage of older adults. Additionally, there were many conditions for which overall enrollment rates for older adults were lower than would be expected. For example, while 10% of participants in studies related to diabetes were ≥ 65 years old, older individuals represent 43% of all prevalent diabetes in the USA. Researchers should work with clinicians to advocate for older adults and ensure their participation in clinical research. Best practices and resources for overcoming common barriers to the inclusion of older adults in research could also be disseminated.

BackgroundMobile phone short message service (SMS) text messaging, has the potential to serve as an intervention medium to promote sustainability of weight loss that can be easily and affordably used by clinicians and consumers. ObjectiveTo develop theoretically driven weight loss sustaining text messages and pilot an mHealth SMS text messaging intervention to promote sustaining recent weight loss in order to understand optimal frequency and timing of message delivery, and for feasibility and usability testing. Results from the pilot study were used to design and construct a patient privacy compliant automated SMS application to deliver weight loss sustaining messages. MethodsWe first conducted a pilot study in which participants (N=16) received a daily SMS text message for one month following a structured weight loss program. Messages were developed from diet and exercise guidelines. Following the intervention, interviews were conducted and self-reported weight was collected via SMS text messaging. ResultsAll participants (N=16) were capable of sending and receiving SMS text messages. During the phone interview at 1 month post-baseline and at 3 months post-baseline, 13/14 (93%) of participants who completed the study reported their weight via SMS. At 3 months post-baseline, 79% (11/14) participants sustained or continued to lose weight. Participants (13/14, 93%) were favorable toward the messages and the majority (10/14, 71%) felt they were useful in helping them sustain weight loss. All 14 participants who completed the interview thought SMS was a favorable communication medium and was useful to receive short relevant messages promptly and directly. All participants read the messages when they knew they arrived and most (11/14, 79%) read the messages at the time of delivery. All participants felt that at least one daily message is needed to sustain weight loss behaviors and that they should be delivered in the morning. Results were then used to develop the SMS text messaging application. ConclusionsStudy results demonstrated the feasibility of developing weight loss SMS text messages, and the development of an mHealth SMS text messaging application. SMS text messaging was perceived as an appropriate and accepted tool to deliver health promotion content.

Objective: This study examined the prevalence of food insecurity (FI) among students attending Historically Black Colleges and Universities (HBCUs) in the Southeastern United States. Participants: Students attending four HBCUs (N = 351) completed an anonymous Web-based survey. Methods: Food insecurity was assessed using the 2-item Hunger Vital Sign Tool. Summary statistics were used to quantify FI experiences. Logistic regression was conducted to determine if student demographic characteristics were significantly associated with FI outcomes. Results: Nearly 3 in 4 students (72.9%) reported some level of FI in the past year. Students representing all levels of postsecondary education reported FI. Meal plan participation did not prevent FI. Conclusions: Students attending HBCUs experience FI at levels that exceed estimates reported among students attending predominantly White institutions. More work is needed to understand the lived experience of food-insecure HBCU students as a means to ensure institution-level food policies support student academic success and wellbeing.

BackgroundEpilepsy affects nearly 50 million people worldwide. Self-management is critical for individuals with epilepsy in order to maintain optimal physical, cognitive, and emotional health. Implementing and adopting a self-management program requires considering many factors at the person, program, and systems levels. We conducted a systematic review of qualitative and mixed-methods studies to identify facilitators and barriers that impact implementation and adoption of self-management programs for adults with epilepsy.MethodsWe used established systematic review methodologies for qualitative and mixed-methods studies. We included studies addressing facilitators (i.e., factors that aided) or barriers (i.e., factors that impeded) to implementation and adoption of self-management interventions for adults with epilepsy. We conducted a narrative thematic synthesis to identify facilitators and barriers.ResultsThe literature search identified 2700 citations; 13 studies met eligibility criteria. Our synthesis identified five themes that categorize facilitators and barriers to successful implementation epilepsy self-management: (1) relevance, intervention content that facilitates acquisition of self-management skills; (2) personalization, intervention components that account for the individual's social, physical, and environmental characteristics; (3) intervention components, components and dosing of the intervention; (4) technology considerations, considerations that account for individual's use, familiarity with, and ownership of technology; and (5) clinician interventionist, role and preparation of the individual who leads intervention. We identified facilitators in 11 of the 13 studies and barriers in 11 of the 13 studies and classified these by social-ecological level (i.e., patient/caregiver, program, site/system).ConclusionIdentification of facilitators and barriers at multiple levels provides insight into disease-specific factors that influence implementation and adoption of self-management programs for individuals with epilepsy. Our findings indicate that involving individuals with epilepsy and their caregivers in intervention development, and then tailoring intervention content during the intervention, can help ensure the content is relevant to intervention participants. Our findings also indicate the role of the clinician (i.e., the individual who provides self-management education) is important to intervention implementation, and key issues with clinicians were identified as barriers and opportunities for improvement. Overall, our findings have practical value for those seeking to implement and adopt self-management interventions for epilepsy and other chronic illnesses.Systematic review registrationPROSPERO registration number is CRD42018098604.

Antiretroviral therapy (ART) prevented premature mortality and improved the quality of life among people living with the human immunodeficiency virus (PLWH), such that now more than half of PLWH in the United States are 50 years of age and older. Increased longevity among PLWH has resulted in a significant rise in chronic, comorbid diseases. However, the implementation of guideline-based interventions for preventing, treating, and managing such age-related, chronic conditions among the HIV population is lacking. The PRECluDE consortium supported by the Center for Translation Research and Implementation Science at the National Heart, Lung, and Blood Institute catalyzes implementation research on proven-effective interventions for co-occurring heart, lung, blood, and sleep diseases and conditions among PLWH. These collaborative research studies use novel implementation frameworks with HIV, mental health, cardiovascular, and pulmonary care to advance comprehensive HIV and chronic disease healthcare in a variety of settings and among diverse populations.

Background: The practice of preventive health behaviors, such as regular handwashing, use of hand sanitizers, wearing facemasks in public, and maintaining safe physical distance can help contain the spread of the COVID-19 virus. Purpose: This study aimed to understand factors that influence university students' COVID-19 preventive behaviors by using the social ecological model (SEM). Methods: A total of 112 students shared their experiences with COVID-19 including their preventive behaviors by responding to an open-ended question via Qualtrics. Data were analyzed using thematic analysis. Results: The analysis resulted in various preventive factors across five levels of SEM--perceived responsibility for one's health; lack of health insurance coverage; support of preventive measures for the protection of loved ones; dyad health communication; satisfaction with enforcement measures to protect students by universities; health safety prioritization by employers; downplaying susceptibility to the virus; media hype of the virus; and politicization of the virus and lack of regulations; lack of regulations to mandate precautionary measures; and mistrust of information sources. Translation to Health Education Practice: Since the COVID-19 pandemic is ongoing, the findings of this study can be used by college and university administrators to empower and motivate students to engage in COVID-19 preventive measures.

Background: Farm-to-University (Farm2U) programs make healthy eating accessible, easier, and the default option. Yet, few published studies have focused on Farm2U implementations in Historically Black Colleges and Universities (HBCUs) in conjunction with measurements of implementation barriers using the consolidated framework for implementation research (CFIR). Purpose: The purpose of this study was to assess the feasibility of delivering a Farm2U program in four HBCUs in North Carolina. Methods: Using a quasi-experimental pre-posttest design, four HBCUs were allocated to either the intervention or the control group. The program was administered over a 4-month period and data were collected at baseline and at post-program implementation. Results: With a target sample size of 128, we successfully recruited 351 participants, retaining 138 at follow-up, for a retention rate of 39%. Twelve CFIR constructs were measured, ten emerged as facilitators and two as mixed barriers/facilitators to program implementation. We observed an increase in local produce purchases and a significant increase in the daily intake of fruits for students. Discussion: This study demonstrated that a Farm2U program is feasible in HBCUs. Translation to Health Education Practice: Certified Health Education Specialists can use the findings to implement Farm2U programs that promote healthy food environments in school settings.

Objective: To understand the distribution of healthy and unhealthy food stores near historically black colleges and universities (HBCUs). Participants and methods: Using ArcGIS Pro's network analysis tools and ReferenceUSA database, this study characterized the healthy (favorable) and unhealthy (unfavorable) retail food stores within a 5-mile radius, 15-min driving, and 15-min walking distance from each HBCU in North Carolina. Results: Most retail food stores within a 5-mile buffer radius of the 10 HBCUs in North Carolina were unfavorable. Within 15-min driving from each HBCU, 1082 stores (76.0%) were unfavorable food stores, while 332 (24.0%) were favorable. Additionally, there were four favorable and 35 unfavorable retail food stores within the 15-min walking distance of each HBCU. Conclusions: Favorable food retail stores around HBCUs in North Carolina are limited. Researchers, policy makers, and community stakeholders should work together to improve food environments surrounding HBCUs.

Objective: This study will evaluate the feasibility and preliminary effectiveness of the COACH (Community Health Worker Optimization of Antihypertensive Care in HIV) intervention, which integrates hypertension management into existing HIV care for people living with HIV (PLWH) in Tanzania. Methods: The study will be conducted at two HIV Care and Treatment Centers (CTCs) in Tanzania. In a single-arm pre-post feasibility trial, 100 PLWH with hypertension will be enrolled and will receive the six-month intervention. The COACH intervention includes six monthly hypertension educational sessions delivered by community health workers (CHWs) and integrated within HIV CTC visits, monthly blood pressure monitoring, follow up care coordination, fully subsidized antihypertensive medications, a standardized antihypertensive treatment algorithm, and training for providers. The intervention's implementation outcomes will be evaluated using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework, and the primary study outcome (reach of the intervention) will be the proportion of all scheduled intervention sessions attended by participants, a measure of feasibility. Secondary clinical effectiveness outcomes will include adherence to antihypertensive medication, blood pressure control, body mass index, cardiovascular risk, and hypertension knowledge. Significance: The COACH intervention has the potential to significantly improve hypertension management among PLWH in Tanzania by leveraging the existing HIV care infrastructure and CHWs. This study will provide crucial insights into the feasibility and potential effectiveness of the intervention in integrating hypertension care into HIV services, informing larger-scale implementation and policy changes in Tanzania and other resource-limitted settings. Trial registration: Clinical trials.gov Identifer: NCT06503991. [ABSTRACT FROM AUTHOR]

Diabetes distress (DD) is a negative psychosocial response to living with type 2 diabetes mellitus (T2DM). We sought insight into Veterans' experiences with DD in the context of T2DM self-management. The four domains in the Diabetes Distress Scale (i.e. regimen, emotional, interpersonal, healthcare provider) informed the interview guide and analysis (structural coding using thematic analysis). The mean age of the cohort (n = 36) was 59.1 years (SD 10.4); 8.3% of patients were female and 63.9% were Black or Mixed Race; mean A1C was 8.8% (SD 2.0); and mean DDS score was 2.4 (SD 1.1), indicating moderate distress. Veterans described DD and challenges to T2DM self-management across the four domains in the Diabetes Distress Scale. We found that (1) Veterans' challenges with their T2DM self-management routines influenced DD and (2) Veterans experienced DD across a wide range of domains, indicating that clinical interventions should take a "whole-person" approach. Trial Registration: NCT04587336 [ABSTRACT FROM AUTHOR]