Association between monoclonal antibody therapy, vaccination, and longer-term symptom resolution after acute COVID-19.

Effective therapies for reducing post-acute sequelae of COVID-19 (PASC) symptoms are lacking. Evaluate the association between monoclonal antibody (mAb) treatment or COVID-19 vaccination with symptom recovery in COVID-19 participants. The longitudinal survey-based cohort study was conducted from April 2021 to January 2022 across a multihospital Colorado health system. Adults ≥18 years with a positive SARS-CoV-2 test were included. Primary exposures were mAb treatment and COVID-19 vaccination. The primary outcome was time to symptom resolution after SARS-CoV-2 positive test date. The secondary outcome was hospitalization within 28 days of a positive SARS-CoV-2 test. Analysis included 1612 participants, 539 mAb treated, and 486 with ≥2 vaccinations. Time to symptom resolution was similar between mAb treated versus untreated patients (adjusted hazard ratio (aHR): 0.90, 95% CI: 0.77-1.04). Time to symptom resolution was shorter for patients who received ≥2 vaccinations compared to those unvaccinated (aHR: 1.56, 95% CI: 1.31-1.88). 28-day hospitalization risk was lower for patients receiving mAb therapy (adjusted odds ratio [aOR]: 0.31, 95% CI: 0.19-0.50) and ≥2 vaccinations (aOR: 0.33, 95% CI: 0.20-0.55), compared with untreated or unvaccinated status. Analysis included 1612 participants, 539 mAb treated, and 486 with ≥2 vaccinations. Time to symptom resolution was similar between mAb treated versus untreated patients (adjusted hazard ratio (aHR): 0.90, 95% CI: 0.77-1.04). Time to symptom resolution was shorter for patients who received ≥2 vaccinations compared to those unvaccinated (aHR: 1.56, 95% CI: 1.31-1.88). 28-day hospitalization risk was lower for patients receiving mAb therapy (adjusted odds ratio [aOR]: 0.31, 95% CI: 0.19-0.50) and ≥2 vaccinations (aOR: 0.33, 95% CI: 0.20-0.55), compared with untreated or unvaccinated status. COVID-19 vaccination, but not mAb therapy, was associated with a shorter time to symptom resolution. Both were associated with lower 28-day hospitalization.

Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial.

BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known. OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. DESIGN: Pragmatic cluster randomized trial. PARTICIPANTS: A total of 1060 adults with type 2 diabetes in 22 primary care practices. INTERVENTIONS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors). MAIN MEASURES: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models. KEY RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions. CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order. NIH TRIAL REGISTRY NUMBER: NCT03590041.

Rapid Community Translation in the Colorado CEAL (CO-CEAL) Program: Transcreating Messaging to Promote COVID-19 Vaccination.

Providing communities with COVID-19 vaccination information is essential for optimizing equitable vaccine uptake. Using rapid community translation, adapted from Boot Camp Translation, five community teams transcreated COVID-19 vaccination campaigns. Transcreated messaging incorporated community attitudes, culture, and experiences. Using rapid community translation for the promotion of COVID-19 vaccination demonstrates a successful approach to engaging communities most affected by the pandemic to develop messages that reflect community values, assets, and needs, especially when time is of the essence. (Am J Public Health. 2024;114(S1):S50-S54. https://doi.org/10.2105/AJPH.2023.307456).

Quality of life after surgery for lower grade gliomas.

BACKGROUND: Few large studies have investigated quality of life (QOL) for adults diagnosed with lower grade glioma (LGG). METHODS: QOL was assessed for 320 adults with LGG (World Health Organization grade 2/3) enrolled in the International Low Grade Glioma Registry by using the Medical Outcomes Study 36-Item Short Form health survey. Data on symptoms were also collected. QOL outcomes were examined by treatment group and also compared to those from a population-based case-control study of meningioma (the Meningioma Consortium), in which 1722 meningioma cases diagnosed among residents of Connecticut, Massachusetts, California, Texas, and North Carolina from May 1, 2006 through March 14, 2013 were enrolled and frequency matched to 1622 controls by age, sex, and geography. RESULTS: The LGG sample average age is 45 years at the time of interview and 53.1% male. Almost 55% of patients had received radiation and chemotherapy (primarily temozolomide); 32.4% had received neither treatment. Two-thirds of participants with LGG report difficulty with speaking, memory, or thinking, and over one of three reports personality change or difficulty driving. After controlling for age and other comorbidities, individuals with LGG report levels of physical, emotional, and mental health functioning below those reported in a meningioma as well as a general healthy population. CONCLUSIONS: Despite being relatively young, persons with LGG report significantly reduced QOL compared to persons with nonmalignant brain tumors and to a control population, which highlights the need to better acknowledge and manage these symptoms for this group of patients diagnosed in the prime of life.

Medication Adherence Rates in Adolescents With Eosinophilic Esophagitis Are Low and Are Associated With Health Habits.

Although swallowed topical steroids are effective in inducing histological remission in eosinophilic esophagitis (EoE), their efficacy is limited by treatment nonadherence. In this study, we objectively measured adherence rates to swallowed topical steroids in adolescents with EoE over the course of 8 weeks and analyzed the association between adherence rate, disease and demographic features, symptom severity, and medication-taking habit strength. We found that approximately 20% of adolescents with EoE were over-dosing on their medications. After excluding these patients, mean adherence rate was 67.0% (±19.4%) and median adherence rate was 63% (interquartile range 53%-88%). Adherence was not associated with demographic features, disease history, symptom severity, or quality of life but was associated with habit strength (Pearson r = 0.48, P = 0.04). These findings suggest that habit strength may serve as a potential target for interventions aimed at improving adherence in adolescents with EoE.

A Multi-Method Study of Patient Reach and Attendance in a Pragmatic Trial of Diabetes Shared Medical Appointments.

Shared medical appointments (SMAs) are an evidence-based approach to diabetes care in primary care settings, yet practices can struggle to ensure participation, especially among racial and ethnic minority and low-income patients. We conducted a multimethod evaluation of reach and attendance in the Invested in Diabetes study of the comparative effectiveness of two SMA delivery models (standardized and patient-driven) in two practice settings (federally qualified health centers [FQHCs] and clinics serving more commercially insured patients). Through this study, 22 practices reached 6.2% of patients with diabetes through SMAs over 3 years, with good attendance for both practice types and both SMA delivery models. FQHCs were especially successful at enrolling underserved populations and improved attendance with virtual SMAs.

Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients.

BACKGROUND: It is not known whether sotrovimab, a neutralizing monoclonal antibody (mAb) treatment authorized for early symptomatic coronavirus disease 2019 (COVID-19) patients, is also effective in preventing the progression of severe disease and mortality following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta variant infection. METHODS: In an observational cohort study of nonhospitalized adult patients with SARS-CoV-2 infection, 1 October 2021-11 December 2021, using electronic health records from a statewide health system plus state-level vaccine and mortality data, we used propensity matching to select 3 patients not receiving mAbs for each patient who received outpatient sotrovimab treatment. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization. RESULTS: Of 10 036 patients with SARS-CoV-2 infection, 522 receiving sotrovimab were matched to 1563 not receiving mAbs. Compared to mAb-untreated patients, sotrovimab treatment was associated with a 63% decrease in the odds of all-cause hospitalization (raw rate 2.1% vs 5.7%; adjusted odds ratio [aOR], 0.37; 95% confidence interval [CI], .19-.66) and an 89% decrease in the odds of all-cause 28-day mortality (raw rate 0% vs 1.0%; aOR, 0.11; 95% CI, .0-.79), and may reduce respiratory disease severity among those hospitalized. CONCLUSIONS: Real-world evidence demonstrated sotrovimab effectiveness in reducing hospitalization and all-cause 28-day mortality among COVID-19 outpatients during the Delta variant phase.

Designing for Dissemination and Sustainability to Promote Equitable Impacts on Health.

Designing for dissemination and sustainability (D4DS) refers to principles and methods for enhancing the fit between a health program, policy, or practice and the context in which it is intended to be adopted. In this article we first summarize the historical context of D4DS and justify the need to shift traditional health research and dissemination practices. We present a diverse literature according to a D4DS organizing schema and describe a variety of dissemination products, design processes and outcomes, and approaches to messaging, packaging, and distribution. D4DS design processes include stakeholder engagement, participatory codesign, and context and situation analysis, and leverage methods and frameworks from dissemination and implementation science, marketing and business, communications and visualarts, and systems science. Finally, we present eight recommendations to adopt a D4DS paradigm, reflecting shifts in ways of thinking, skills and approaches, and infrastructure and systems for training and evaluation.

Clinician Perspectives on Monoclonal Antibody Treatment for High-Risk Outpatients with COVID-19: Implications for Implementation and Equitable Access.

BACKGROUND: There is an urgent need to identify and address factors influencing uptake and equitable access to monoclonal antibody (mAb) treatment for high-risk outpatients with COVID-19. OBJECTIVE: To assess clinician knowledge, beliefs, and experiences regarding obtaining mAb treatment for eligible patients. DESIGN AND PARTICIPANTS: Survey of clinicians (N = 374) practicing in the state of Colorado who care for patients with COVID-19 in primary care, emergency medicine, and other clinical settings. MAIN MEASURE(S): Diffusion of innovation theory concepts including knowledge, perceived strength of evidence, barriers, and experience with, ease of use, preparedness, and feasibility, appropriateness, and acceptability of mAb referral systems and processes. KEY RESULTS: Most respondents indicated little to no knowledge about mAb therapies for COVID-19 (67%, 74%, 77%, for bamlanivimab, bamlanivimab+etesivimab, and casirivimab+imdevimab, respectively). About half reported little to no familiarity with eligibility criteria (50.9%) and did not know the strength of evidence (31%, 43%, 52%, for bamlanivimab, bamlanivimab+etesivimab, and casirivimab+imdevimab, respectively). Lack of knowledge or confidence in treatment was a top barrier to mAbs use; other barriers included complicated referral processes, patients not eligible when seen, and out-of-pocket costs concerns. Respondents rated four mAb referral steps as generally acceptable, appropriate, and feasible to complete in their primary outpatient clinical setting. Only 24% indicated their clinical setting was very prepared to facilitate referrals, 40% had ever referred a patient for mAbs, and 43% intended to refer a patient in the next month. CONCLUSIONS: Clinician education on strength of evidence and eligibility criteria for mAbs is needed. However, education alone is not sufficient. Given the urgent need to rapidly scale up access to treatment and reduce hospitalizations and death from COVID-19, more efficient, equitable systems and processes for referral and delivery of care, such as those coordinated by health systems, public health departments, or disaster management services, are warranted.

Implementation and Qualitative Evaluation of a Primary Care Redesign Model with Expanded Scope of Work for Medical Assistants.

BACKGROUND: Implementation of primary care models involving expanded scope of work and redesigned workflows for medical assistants (MAs) as primary care team members can be challenging. Implementation strategies and participatory evaluation informed by implementation science frameworks may inform organizational decisions about model scale-up and sustainment. OBJECTIVE: This paper reports implementation strategies and qualitative evaluation of a primary care redesign (PCR) model implementation that included an expanded scope of work for MAs. DESIGN: Qualitative evaluation of implementation strategies and clinician and staff experience with implementation of PCR using semi-structured key informant interviews. The evaluation was guided by the RE-AIM framework and the Consolidated Framework for Implementation Research. PARTICIPANTS: Sixty-nine clinicians, staff, practice leaders, and administrators from 7 primary care practices (4 general internal medicine, 3 family medicine) implementing PCR. INTERVENTIONS: The PCR model included enhanced rooming and documentation support. The health system used multiple strategies to implement PCR, including rapid improvement events, changing clinic space configurations, developing electronic health record templates and performance dashboards, and practice coaching. APPROACH: The Consolidated Framework for Implementation Research and the RE-AIM evaluation and planning framework guided development of semi-structured interview guides. A deductive, structural coding approach was used for analysis. KEY RESULTS: PCR implementation was facilitated by clear communication about the intervention source, mechanisms for feedback about model goals, and physical environments and electronic health record (EHR) systems that supported the added staff and modified clinic workflow. Clinicians and staff benefited from the ability to see the model in action prior to go-live and opportunities for consistent provider-MA pairings. CONCLUSIONS: The PCR model can support achieving the Quadruple Aim when fully implemented with paired MAs and clinicians who are well prepared to follow redesigned workflows and function as a team. Implementation can be effectively supported by a participatory evaluation guided by implementation science frameworks.

A gratitude intervention to improve clinician stress and professional satisfaction: A pilot and feasibility trial.

OBJECTIVE: Resilience training combined with medical system changes have the potential to reduce clinician burnout. We sought to estimate effects and assess feasibility of a brief gratitude intervention for primary care clinicians. METHODS: This was a pre-test/post-test single group intervention design with longitudinal follow-up. Volunteer participants were from either a primary care community engagement conference or worked at one of two clinical sites in a Western mid-size city. Eligible clinicians held an MD/DO or NP/PA degree and currently worked at least 0.50 FTE in a primary care clinical practice and were willing and able to participate in the initial group session and complete weekly journaling. The gratitude intervention consisted of an in-person 90-minute group psychoeducation and skills-building workshop, followed by an 8-week daily gratitude journal exercise. The primary outcomes were related to resilience, including coping self-efficacy, clinician autonomy, and self-care behaviors. The secondary outcomes were the feasibility and acceptability of the intervention, as well as career satisfaction, and types and frequency of things for which clinicians were grateful in their daily work. RESULTS: The intervention was brief, feasible, and of interest to clinicians. Statistically significant improvements were seen in most outcome measures at both 4 and 8 weeks follow-up, with the exception of gratitude, which also increased, but not significantly so. Gratitude categories mentioned most frequently were support platforms at work (47%) and sense of competence (42%). CONCLUSIONS: The intervention had positive effects on resilience and is a promising brief intervention for clinicians experiencing stress. Larger experimental designs are needed.

Medication Adherence Aligns with Age and a Behavioral Checklist but Not Symptoms or Quality of Life for Patients with Eosinophilic Esophagitis.

OBJECTIVE: To measure adherence rates to swallowed topical steroids in children with eosinophilic esophagitis (EoE), describe factors related to adherence, and determine the association between adherence, symptoms, perceived disease severity, and quality of life in children with EoE. STUDY DESIGN: Subjects in this cross-sectional study of 117 children between 5 and 18 years old with EoE completed the Pediatric Eosinophilic Esophagitis Symptoms Score V2.0 (PEESS), Pediatric Quality of Life Inventory Eosinophilic Esophagitis Module (PedsQL EoE), a Medication-Taking Checklist (MTC), and a demographics questionnaire. Adherence rate was calculated based on reported number of missed doses/prescribed doses in the last week. Parent-reported measures were used for children aged 5-12 years and self-report was used for children aged 13-18 years. RESULTS: Adolescents had lower adherence rates than younger children (76.2 ± 24.5% vs 88.6 ± 16.7%, P = .002). Adherence rates were not associated with disease history, PEESS, or PedsQL EoE scores but instead correlated with MTC scores (Pearson r of 0.65, P < .001 for child-report and Pearson r of 0.74, P < .001 for parent-report). Symptomatology was associated with worse quality of life (PEESS Frequency: r = -0.7, P < .001; PEESS Severity: r = -0.71, P < .001 for children 5-12 years old; PEESS Frequency: r = -0.61, P < .001; PEESS Severity: r = -.5, P < .001 for adolescents). CONCLUSIONS: Unrelated to their clinical history, demographic factors, symptoms, and quality of life, adolescents with EoE have lower medication adherence rates. The MTC may serve as a clinical tool to discuss adherence and provide targeted educational counseling regarding adherence interventions.

Personal Continuous Glucose Monitoring Use Among Adults with Type 2 Diabetes: Clinical Efficacy and Economic Impacts.

PURPOSE OF REVIEW: This article reviews recent clinical efficacy research and economic analysis of the use of personal continuous glucose monitoring (CGM) in type 2 diabetes (T2D). RECENT FINDINGS: Studies from the past 5 years include a variety of randomized controlled trials, meta-analyses, and other studies which generally favor CGM over self-monitoring of blood glucose (SMBG) in T2D, especially among people with T2D treated with insulin. Concurrently, some studies show no significant difference, but there is no evidence of worse outcomes with CGM. CGM is frequently associated with greater reduction in HbA1c than is SMBG. HbA1c reductions tend to be greater when baseline HbA1c is higher. Reductions in hypoglycemia and hyperglycemia have also been demonstrated with CGM in people with T2D, as have comfort with, preference for, and psychosocial benefits of CGM compared to SMBG. There is a small but growing evidence base on the economics and cost-effectiveness of CGM in T2D. CGM has been clearly demonstrated to have clinical benefits in people with T2D, especially among those treated with insulin. Economic and cost-effectiveness data are more scant but are generally favorable. CGM should be an important consideration in the management of T2D, and its use is likely to increase as efficacy data accumulate further and as costs associated with CGM gradually decrease.

Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.

BACKGROUND: This report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations. METHODS: We report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics. RESULTS: In general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings. CONCLUSIONS: We discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research. TRIAL REGISTRATION: Clinicaltrials.gov Registration ID: NCT03590041 .

The pragmatic, rapid, and iterative dissemination and implementation (PRIDI) cycle: adapting to the dynamic nature of public health emergencies (and beyond).

BACKGROUND: Public health emergencies-such as the 2020 COVID-19 pandemic-accelerate the need for both evidence generation and rapid dissemination and implementation (D&I) of evidence where it is most needed. In this paper, we reflect on how D&I frameworks and methods can be pragmatic (i.e., relevant to real-world context) tools for rapid and iterative planning, implementation, evaluation, and dissemination of evidence to address public health emergencies. THE PRAGMATIC, RAPID, AND ITERATIVE D&I (PRIDI) CYCLE: The PRIDI cycle is based on a "double-loop" learning process that recognizes the need for responsiveness and iterative adaptation of implementation cycle (inner loop) to the moving landscapes, presented by the outer loops of emerging goals and desired outcomes, emerging interventions and D&I strategies, evolving evidence, and emerging characteristics and needs of individuals and contexts. Stakeholders iteratively evaluate these surrounding landscapes of implementation, and reconsider implementation plans and activities. CONCLUSION: Even when the health system priority is provision of the best care to the individuals in need, and scientists are focused on development of effective diagnostic and therapeutic technologies, planning for D&I is critical. Without a flexible and adaptive process of D&I, which is responsive to emerging evidence generation cycles, and closely connected to the needs and priorities of stakeholders and target users through engagement and feedback, the interventions to mitigate public health emergencies (e.g., COVID-19 pandemic), and other emerging issues, will have limited reach and impact on populations that would most benefit. The PRIDI cycle is intended to provide a pragmatic approach to support planning for D&I throughout the evidence generation and usage processes.

Brain Tumor Discussions on Twitter (#BTSM): Social Network Analysis.

BACKGROUND: The Brain Tumor Social Media (#BTSM) Twitter hashtag was founded in February 2012 as a disease-specific hashtag for patients with brain tumor. OBJECTIVE: To understand #BTSM's role as a patient support system, we describe user descriptors, growth, interaction, and content sharing. METHODS: We analyzed all tweets containing #BTSM from 2012 to 2018 using the Symplur Signals platform to obtain data and to describe Symplur-defined user categories, tweet content, and trends in use over time. We created a network plot with all publicly available retweets involving #BTSM in 2018 to visualize key stakeholders and their connections to other users. RESULTS: From 2012 to 2018, 59,764 unique users participated in #BTSM, amassing 298,904 tweets. The yearly volume of #BTSM tweets increased by 264.57% from 16,394 in 2012 to 43,373 in 2018 with #BTSM constantly trending in the top 15 list of disease hashtags, as well the top 15 list of tweet chats. Patient advocates generated the most #BTSM tweets (33.13%), while advocacy groups, caregivers, doctors, and researchers generated 7.01%, 4.63%, 3.86%, and 3.37%, respectively. Physician use, although still low, has increased over time. The 2018 network plot of retweets including #BTSM identifies a number of key stakeholders from the patient advocate, patient organization, and medical researcher domains and reveals the extent of their reach to other users. CONCLUSIONS: From its start in 2012, #BTSM has grown exponentially over time. We believe its growth suggests its potential as a global source of brain tumor information on Twitter for patients, advocates, patient organizations as well as health care professionals and researchers.

A Values-Tailored Web-Based Intervention for New Mothers to Increase Infant Vaccine Uptake: Development and Qualitative Study.

BACKGROUND: Vaccine hesitancy among parents leads to childhood undervaccination and outbreaks of vaccine-preventable disease. As the reasons for vaccine hesitancy are diverse, there is often not enough time during regular clinical visits for medical providers to adequately address all the concerns that parents have. Providing individually tailored vaccine information via the internet before a clinical visit may be a good mechanism for effectively allaying parents' vaccination concerns while also being time efficient. Including tailoring based on values is a promising, but untested, approach to message creation. OBJECTIVE: This study aimed to describe the process by which we developed a Web-based intervention that is being used in an ongoing randomized controlled trial aimed at improving the timeliness of infant vaccination by reducing parental vaccine hesitancy. METHODS: Development of the intervention incorporated evidence-based health behavior theories. A series of interviews, surveys, and feedback sessions were used to iteratively develop the intervention in collaboration with vaccination experts and potential end users. RESULTS: In all, 41 specific content areas were identified to be included in the intervention. User feedback elucidated preferences for specific design elements to be incorporated throughout the website. The tile-based architecture chosen for the website was perceived as easy to use. Creating messages that were two-sided was generally preferred over other message formats. Quantitative surveys identified associations between specific vaccine values and vaccination beliefs, suggesting that values tailoring should vary, depending on the specific belief being endorsed. CONCLUSIONS: Using health behavior theories, qualitative and quantitative data, and significant expert and end user input, we created a novel, Web-based intervention to improve infant vaccination timeliness. The intervention is based on tailoring messages according to each individual's values and beliefs. This intervention is currently being tested in a controlled randomized clinical trial.

Community Health Workers: Addressing Client Objectives Among Frequent Emergency Department Users.

OBJECTIVES: To evaluate effectiveness of a community health worker (CHW) program designed to address client objectives among frequent emergency department (ED) users. DESIGN: Program evaluation using secondary analysis of client objectives from program records. Client objectives were characterized according to the World Health Organization's social determinants of health framework. Hierarchical generalized linear modeling was used to assess factors associated with objective achievement. SETTING: An ED and the surrounding community in an economically disadvantaged area of Buffalo, New York. PARTICIPANTS: A total of 1600 adults over age 18 eligible for Medicaid and/or Medicare and who had at least 2 ED visits in the prior year. INTERVENTION: Clients worked with CHWs in the community to identify diverse needs and objectives. Community health workers provided individualized services to help achieve objectives. MAIN OUTCOME MEASURE: Achievement of client-focused objectives. RESULTS: Most objectives pertained to linkage to community resources and health care navigation, emphasizing chronic medical conditions and connection to primary care. Clients and CHWs together achieved 43% of total objectives. Objective achievement was positively associated with greater client engagement in CHW services. CONCLUSIONS: Low objective achievement may stem from system- and policy-level barriers, such as lack of affordable housing and access to primary care. Strategies for improving client engagement in CHW services are needed. Community health workers and their clients were most successful in areas in which public health policies and systems made resources easy to access or where the program had formalized relationships with resources, such as primary care.

Stakeholder engagement in diabetes self-management: patient preference for peer support and other insights.

Background: Self-management support (SMS) for patients with diabetes can improve adherence to treatment, mitigate disease-related distress, and improve health outcomes. Translating this evidence into real-world practice is needed, as it is not clear which SMS models are acceptable to patients, and feasible and sustainable for primary care practices. Objective: To use the Boot Camp Translation (BCT) method to engage patient, practice, community resource and research stakeholders in translation of evidence about SMS and diabetes distress into mutually acceptable care models and to inform patient-centred outcomes research (PCOR). Participants: Twenty-seven diabetes care stakeholders, including patients and providers from a local network of federally qualified health centres participated. Methods: Stakeholders met in-person and by conference call over the course of 8 months. Subject matter experts provided education on the diabetes SMS evidence. Facilitators engaged the group in discussions about barriers to self-management and opportunities for improving delivery of SMS. Key Results: BCT participants identified lack of social support, personal resources, trust, knowledge and confidence as barriers to diabetes self-management. Intervention opportunities emphasized peer support, use of multidisciplinary care teams and centralized systems for sharing information about community and practice resources. BCT informed new services and a PCOR study proposal. Conclusions: Patients and family engaged in diabetes care research value peer support, group visits, and multidisciplinary care teams as key features of SMS models. SMS should be tailored to an individual patient's health literacy. BCT can be used to engage multiple stakeholders in translation of evidence into practice and to inform PCOR.

Dynamic-ETL: a hybrid approach for health data extraction, transformation and loading.

BACKGROUND: Electronic health records (EHRs) contain detailed clinical data stored in proprietary formats with non-standard codes and structures. Participating in multi-site clinical research networks requires EHR data to be restructured and transformed into a common format and standard terminologies, and optimally linked to other data sources. The expertise and scalable solutions needed to transform data to conform to network requirements are beyond the scope of many health care organizations and there is a need for practical tools that lower the barriers of data contribution to clinical research networks. METHODS: We designed and implemented a health data transformation and loading approach, which we refer to as Dynamic ETL (Extraction, Transformation and Loading) (D-ETL), that automates part of the process through use of scalable, reusable and customizable code, while retaining manual aspects of the process that requires knowledge of complex coding syntax. This approach provides the flexibility required for the ETL of heterogeneous data, variations in semantic expertise, and transparency of transformation logic that are essential to implement ETL conventions across clinical research sharing networks. Processing workflows are directed by the ETL specifications guideline, developed by ETL designers with extensive knowledge of the structure and semantics of health data (i.e., "health data domain experts") and target common data model. RESULTS: D-ETL was implemented to perform ETL operations that load data from various sources with different database schema structures into the Observational Medical Outcome Partnership (OMOP) common data model. The results showed that ETL rule composition methods and the D-ETL engine offer a scalable solution for health data transformation via automatic query generation to harmonize source datasets. CONCLUSIONS: D-ETL supports a flexible and transparent process to transform and load health data into a target data model. This approach offers a solution that lowers technical barriers that prevent data partners from participating in research data networks, and therefore, promotes the advancement of comparative effectiveness research using secondary electronic health data.