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.

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).

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.

A randomized, parallel group, pragmatic comparative-effectiveness trial comparing medication-assisted treatment induction methods in primary care practices: The HOMER study protocol.

Opioid use disorder (OUD) represents a public health crisis in the United States. Medication for opioid use disorder (MOUD) with buprenorphine in primary care is a proven OUD treatment strategy. MOUD induction is when patients begin withdrawal and receive the first doses of buprenorphine. Differences between induction methods might influence short-term stabilization, long-term maintenance, and quality of life. This paper describes the protocol for a study designed to: (1) compare short-term stabilization and long-term maintenance treatment engagement in MOUD in patients receiving office, home, or telehealth induction and (2) identify clinically-relevant practice and patient characteristics associated with successful long-term treatment. The study design is a randomized, parallel group, pragmatic comparative effectiveness trial of three care models of MOUD induction in 100 primary care practices in the United States. Eligible patients are at least 16 years old, have been identified by their clinician as having opioid dependence and would benefit from MOUD. Patients will be randomized to one of three induction comparators: office, home, or telehealth induction. Primary outcomes are buprenorphine medication-taking and illicit opioid use at 30, 90, and 270 days post-induction. Secondary outcomes include quality of life and potential mediators of treatment maintenance (intentions, planning, automaticity). Potential moderators include social determinants of health, substance use history and appeal, and executive function. An intent to treat analysis will assess effects of the interventions on long-term treatment, using general/generalized linear mixed models, adjusted for covariates, for the outcomes analysis. Analysis includes practice- and patient-level random effects for hierarchical/longitudinal data. No large-scale, randomized comparative effectiveness research has compared home induction to office or telehealth MOUD induction on long-term outcomes for patients with OUD seen in primary care settings. The results of this study will offer primary care providers evidence and guidance in selecting the most beneficial induction method(s) for specific patients.

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.

Engaging Patients and Other Stakeholders in "Designing for Dissemination" of Record Linkage Methods and Tools.

BACKGROUND: Novel record linkage (RL) methods have the potential to enhance clinical informatics by integrating patient data from multiple sources-including electronic health records, insurance claims, and digital health devices-to inform patient-centered care. Engaging patients and other stakeholders in the use of RL methods in patient-centered outcomes research (PCOR) is a key step in ensuring RL methods are viewed as acceptable, appropriate, and useful. The University of Colorado Record Linkage (CURL) platform empowers the use of RL in PCOR. OBJECTIVES: This study aimed to describe the process of engaging patients and other stakeholders in the design of an RL dissemination package to support the use of RL methods in PCOR. METHODS: Customer discovery, value proposition design, and user experience methods were used to iteratively develop an RL dissemination package that includes animated explainer videos for patients and an RL research planning workbook for researchers. Patients and other stakeholders (researchers, data managers, and regulatory officials) were engaged in the RL dissemination package design. RESULTS: Patient partners emphasized the importance of conveying how RL methods may benefit patients and the rules researchers must follow to protect the privacy and security of patient data. Other stakeholders described accuracy, flexibility, efficiency, and data security compared with other available RL solutions. Dissemination package communication products reflect the value propositions identified by key stakeholders. As prioritized by patients, the animated explainer videos emphasize the data privacy and security processes and procedures employed when performing research using RL. The RL workbook addresses researchers' and data managers' needs to iteratively design RL projects and provides accompanying resources to alleviate leadership and regulatory officials' concerns about data regulation compliance. CONCLUSION: Dissemination products to promote adoption and use of CURL include materials to facilitate patient engagement in RL research and investigator step-by-step decision-making materials about the integration of RL methods in PCOR.

A Transgender Health Information Resource: Participatory Design Study.

BACKGROUND: Despite the abundance of health information on the internet for people who identify as transgender and gender diverse (TGD), much of the content used is found on social media channels, requiring individuals to vet the information for relevance and quality. OBJECTIVE: We developed a prototype transgender health information resource (TGHIR) delivered via a mobile app to provide credible health and wellness information for people who are TGD. METHODS: We partnered with the TGD community and used a participatory design approach that included focus groups and co-design sessions to identify users' needs and priorities. We used the Agile software development methodology to build the prototype. A medical librarian and physicians with expertise in transgender health curated a set of 97 information resources that constituted the foundational content of the prototype. To evaluate the prototype TGHIR app, we assessed the app with test users, using a single item from the System Usability Scale to assess feature usability, cognitive walk-throughs, and the user version of the Mobile Application Rating Scale to evaluate the app's objective and subjective quality. RESULTS: A total of 13 people who identified as TGD or TGD allies rated their satisfaction with 9 of 10 (90%) app features as good to excellent, and 1 (10%) of the features-the ability to filter to narrow TGHIR resources-was rated as okay. The overall quality score on the user version of the Mobile Application Rating Scale was 4.25 out of 5 after 4 weeks of use, indicating a good-quality mobile app. The information subscore received the highest rating, at 4.75 out of 5. CONCLUSIONS: Community partnership and participatory design were effective in the development of the TGHIR app, resulting in an information resource app with satisfactory features and overall high-quality ratings. Test users felt that the TGHIR app would be helpful for people who are TGD and their care partners.

Community Engagement in Research and Design of a Transgender Health Information Resource.

BACKGROUND: Access to credible and relevant health care information is an unmet need for the transgender and gender-diverse (TGD) community. This paper describes the community engagement methods and resulting community priorities as part of a codesign process for the development of a Transgender Health Information Resource (TGHIR) application. METHODS: A lesbian, gay, bisexual, transgender, and queer advocacy organization and an academic health sciences team partnered to establish a community advisory board (CAB) of TGD individuals, parents of TGD individuals, and clinicians with expertise in transgender health to inform the project. The analytic-deliberative model and group facilitation strategies based on Liberating Structures guided procedures. Affinity grouping was used to synthesize insights from CAB meeting notes regarding roles and perspectives on the design of the TGHIR application. We used the Patient Engagement in Research Scale (PEIRS) to evaluate CAB members' experience with the project. RESULTS: The CAB emphasized the importance of designing the application with and for the TGD community, including prioritizing intersectionality and diversity. CAB engagement processes benefited from setting clear expectations, staying focused on goals, synchronous and asynchronous work, and appreciating CAB member expertise. TGHIR application scope and priorities included a single source to access relevant, credible health information, the ability to use the app discreetly, and preserving privacy (i.e., safe use). An out-of-scope CAB need was the ability to identify both culturally and clinically competent TGD health care providers. PEIRS results showed CAB members experienced moderate to high levels of meaningful engagement (M[standard deviation] = 84.7[12] out of 100). CONCLUSION: A CAB model was useful for informing TGHIR application priority features. In-person and virtual methods were useful for engagement. The CAB continues to be engaged in application development, dissemination, and evaluation. The TGHIR application may complement, but will not replace, the need for both culturally and clinically competent health care for TGD people.

Delivering diabetes shared medical appointments in primary care: early and mid-program adaptations and implications for successful implementation.

BACKGROUND: Self-management is essential for good outcomes in type 2 diabetes and patients often benefit from self-management education. Shared medical appointments (SMAs) can increase self-efficacy for self management but are difficult for some primary care practices to implement. Understanding how practices adapt processes and delivery of SMAs for patients with type 2 diabetes may provide helpful strategies for other practices interested in implementing SMAs. METHODS: The Invested in Diabetes study was a pragmatic cluster-randomized, comparative effectiveness trial designed to compare two different models of diabetes SMAs delivered in primary care. We used a multi-method approach guided by the FRAME to assess practices' experience with implementation, including any planned and unplanned adaptations. Data sources included interviews, practice observations and field notes from practice facilitator check-ins. RESULTS: Several findings were identified from the data: 1) Modifications and adaptations are common in implementation of SMAs, 2) while most adaptations were fidelity-consistent supporting the core components of the intervention conditions as designed, some were not, 3) Adaptations were perceived to be necessary to help SMAs meet patient and practice needs and overcome implementation challenges, and 4) Content changes in the sessions were often planned and enacted to better address the contextual circumstances such as patient needs and culture. DISCUSSION: Implementing SMAs in primary care can be challenging and adaptations of both implementation processes and content and delivery of SMAS for patients with type 2 diabetes were common in the Invested in Diabetes study. Recognizing the need for adaptations based on practice context prior to implementation may help improve fit and success with SMAs, but care needs to be given to ensure that adaptations do not weaken the impact of the intervention. Practices may be able to assess what might need to adapted for them to be successful prior to implementation but likely will continue to adapt after implementation. CONCLUSION: Adaptations were common in the Invested in Diabetes study. Practices may benefit from understanding common challenges in implementing SMAs and adapting processes and delivery based on their own context. TRIAL REGISTRATION: This trial is registered on clinicaltrials.gov under Trial number NCT03590041, posted 18/07/2018.

Priorities to Promote Participant Engagement in the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network.

BACKGROUND: Engaging diverse populations in cancer genomics research is of critical importance and is a fundamental goal of the NCI Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network. Established as part of the Cancer Moonshot, PE-CGS is a consortium of stakeholders including clinicians, scientists, genetic counselors, and representatives of potential study participants and their communities. Participant engagement is an ongoing, bidirectional, and mutually beneficial interaction between study participants and researchers. PE-CGS sought to set priorities in participant engagement for conducting the network's research. METHODS: PE-CGS deliberatively engaged its stakeholders in the following four-phase process to set the network's research priorities in participant engagement: (i) a brainstorming exercise to elicit potential priorities; (ii) a 2-day virtual meeting to discuss priorities; (iii) recommendations from the PE-CGS External Advisory Panel to refine priorities; and (iv) a virtual meeting to set priorities. RESULTS: Nearly 150 PE-CGS stakeholders engaged in the process. Five priorities were set: (i) tailor education and communication materials for participants throughout the research process; (ii) identify measures of participant engagement; (iii) identify optimal participant engagement strategies; (iv) understand cancer disparities in the context of cancer genomics research; and (v) personalize the return of genomics findings to participants. CONCLUSIONS: PE-CGS is pursuing these priorities to meaningfully engage diverse and underrepresented patients with cancer and posttreatment cancer survivors as participants in cancer genomics research and, subsequently, generate new discoveries. IMPACT: Data from PE-CGS will be shared with the broader scientific community in a manner consistent with participant informed consent and community agreement.

A multimodal strategy to improve race/ethnic group equity in administration of neutralizing monoclonal antibody treatment for COVID-19 outpatients.

Introduction: Racial and ethnic minority groups have higher rates of SARS-CoV-2 infection, severe illness, and death; however, they receive monoclonal antibody (mAb) treatment at lower rates than non-Hispanic White patients. We report data from a systematic approach to improve equitable provision of COVID-19 neutralizing monoclonal antibody treatment. Methods: Treatment was administered at a community health urgent care clinic affiliated with a safety-net urban hospital. The approach included a stable treatment supply, a same-day test and treat model, a referral process, patient outreach, and financial support. We analyzed the race/ethnicity data descriptively and compared proportions using a chi-square test. Results: Over 17 months, 2524 patients received treatment. Compared to the demographics of county COVID-19-positive cases, a greater proportion of patients who received mAb treatment were Hispanic (44.7% treatment vs. 36.5% positive cases, p < 0.001), a lower proportion were White Non-Hispanic (40.7% treatment vs. 46.3% positive cases, p < 0.001), equal proportion were Black (8.2% treatment vs. 7.4% positive cases, P = 0.13), and equal proportion occurred for other race patients. Discussion: Implementation of multiple systematic strategies to administer COVID-19 monoclonal antibodies resulted in an equitable race/ethnic distribution of treatment.

Co-design of the Transgender Health Information Resource: Web-Based Participatory Design.

BACKGROUND: There is an urgent and unmet need for accessible and credible health information within the transgender and gender-diverse (TGD) community. Currently, TGD individuals often seek and must find relevant resources by vetting social media posts. A resource that provides accessible and credible health-related resources and content via a mobile phone app may have a positive impact on and support the TGD population. OBJECTIVE: COVID-19 stay-at-home orders forced a shift in the methods used in participatory design. In this paper, we aimed to describe the web-based participatory methods used to develop the Transgender Health Information Resource. We also described and characterized the web-based engagement that occurred during a single session of the overall design process. METHODS: We planned and conducted web-based design sessions to replace the proposed in-person sessions. We used web-based collaborative tools, including Zoom (Zoom Video Communications), Mural (Mural), REDCap (Research Electronic Data Capture; Vanderbilt University), and Justinmind (Justinmind), to engage the participants in the design process. Zoom was used as an integrated platform for design activities. Mural was used to perform exercises, such as free listing, brainstorming, and grouping. REDCap allowed us to collect survey responses. Justinmind was used to create prototypes that were shared and discussed via Zoom. Recruitment was led by one of our community partners, One Colorado, who used private Facebook groups in which web-based flyers were dispersed. The design process took place in several workshops over a period of 10 months. We described and characterized engagement during a single design session by tracking the number of influential interactions among participants. We defined an influential interaction as communication, either verbal or web-based content manipulation, that advanced the design process. RESULTS: We presented data from a single design session that lasted 1 hour and 48 minutes and included 4 participants. During the session, there were 301 influential interactions, consisting of 79 verbal comments and 222 web-based content manipulations. CONCLUSIONS: Web-based participatory design can elicit input and decisions from participants to develop a health information resource, such as a mobile app user interface. Overall, participants were highly engaged. This approach maintained the benefits and fidelity of traditional in-person design sessions, mitigated deficits, and exploited the previously unconsidered benefits of web-based methods, such as enhancing the ability to participate for those who live far from academic institutions. The web-based approach to participatory design was an efficient and feasible methodological design approach.

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

BACKGROUND: Neutralizing monoclonal antibodies (mAbs) were authorized for the treatment of COVID-19 outpatients based on clinical trials completed early in the pandemic, which were underpowered for mortality and subgroup analyses. Real-world data studies are promising for further assessing rapidly deployed therapeutics. RESEARCH QUESTION: Did mAb treatment prevent progression to severe disease and death across pandemic phases and based on risk factors, including prior vaccination status? STUDY DESIGN AND METHODS: This observational cohort study included nonhospitalized adult patients with SARS-CoV-2 infection from November 2020 to October 2021 using electronic health records from a statewide health system plus state-level vaccine and mortality data. Using propensity matching, we selected approximately 2.5 patients not receiving mAbs for each patient who received mAb treatment under emergency use authorization. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and hospitalization severity. RESULTS: Of 36,077 patients with SARS-CoV-2 infection, 2,675 receiving mAbs were matched to 6,677 patients not receiving mAbs. Compared with mAb-untreated patients, mAb-treated patients had lower all-cause hospitalization (4.0% vs 7.7%; adjusted OR, 0.48; 95% CI, 0.38-0.60) and all-cause mortality (0.1% vs 0.9%; adjusted OR, 0.11; 95% CI, 0.03-0.29) to day 28; differences persisted to day 90. Among hospitalized patients, mAb-treated patients had shorter hospital length of stay (5.8 vs 8.5 days) and lower risk of mechanical ventilation (4.6% vs 16.6%). Results were similar for preventing hospitalizations during the Delta variant phase (adjusted OR, 0.35; 95% CI, 0.25-0.50) and across subgroups. Number-needed-to-treat (NNT) to prevent hospitalization was lower for subgroups with higher baseline risk of hospitalization; for example, multiple comorbidities (NNT = 17) and not fully vaccinated (NNT = 24) vs no comorbidities (NNT = 88) and fully vaccinated (NNT = 81). INTERPRETATION: Real-world data revealed a strong association between receipt of mAbs and reduced hospitalization and deaths among COVID-19 outpatients across pandemic phases. Real-world data studies should be used to guide practice and policy decisions, including allocation of scarce resources.

Real-world data to evaluate effects of a multi-level dissemination strategy on access, outcomes, and equity of monoclonal antibodies for COVID-19.

Introduction: Multi-level dissemination strategies are needed to increase equitable access to effective treatment for high-risk outpatients with COVID-19, particularly among patients from disproportionately affected communities. Yet assessing population-level impact of such strategies can be challenging. Methods: In collaboration with key contributors in Colorado, we conducted a retrospective cohort study to evaluate a multi-level dissemination strategy for neutralizing monoclonal antibody (mAb) treatment. Real-world data included county-level, de-identified output from a statewide mAb referral registry linked with publicly available epidemiological data. Outcomes included weekly number of mAb referrals, unique referring clinicians, and COVID-19 hospitalization rates. We assessed weekly changes in outcomes after dissemination strategies launched in July 2021. Results: Overall, mAb referrals increased from a weekly average of 3.0 to 15.5, with an increase of 1.3 to 42.1 additional referrals per county in each post-period week (p < .05). Number of referring clinicians increased from a weekly average of 2.2 to 9.7, with an additional 1.5 to 22.2 unique referring clinicians observed per county per week beginning 5 weeks post-launch (p < .001). Larger effects were observed in communities specifically prioritized by the dissemination strategies. There were no observed differences in COVID-19 hospitalization rates between counties with and without mAb treatment sites. Conclusion: Real-world data can be used to estimate population impact of multi-level dissemination strategies. The launch of these strategies corresponded with increases in mAb referrals, but no apparent population-level effects on hospitalization outcomes. Strengths of this analytic approach include pragmatism and efficiency, whereas limitations include inability to control for other contemporaneous trends.

Referrals, access, and equity of monoclonal antibodies for outpatient COVID-19: A qualitative study of clinician perspectives.

Neutralizing monoclonal antibody treatments for non-hospitalized patients with COVID-19 have been available since November 2020. However, they have been underutilized and access has been inequitable. To understand, from the clinician perspective, the factors facilitating or hindering monoclonal antibody referrals, patient access, and equity to inform development of clinician-focused messages, materials, and processes for improving access to therapeutics for COVID-19 in Colorado. We interviewed 38 frontline clinicians with experience caring for patients with COVID-19 in outpatient settings. Clinicians were purposely sampled for diversity to understand perspectives across geography (i.e., urban versus rural), practice setting, specialty, and self-reported knowledge about monoclonal antibodies. Interviews were conducted between June and September 2021, lasted 21 to 62 minutes, and were audio recorded and transcribed verbatim. Interview transcripts were then analyzed using rapid qualitative analysis to identify thematic content and to compare themes across practice settings and other variables. Clinicians perceived monoclonal antibodies to be highly effective and were unconcerned about their emergency use status; hence, these factors were not perceived to hinder patient referrals. However, some barriers to access - including complex and changing logistics for referring, as well as the time and facilities needed for an infusion - inhibited widespread use. Clinicians in small, independent, and rural practices experienced unique challenges, such as lack of awareness of their patients' COVID-19 test results, disconnect from treatment distribution systems, and patients who faced long travel times to obtain treatment. Many clinicians held a persistent belief that monoclonal antibodies were in short supply; this belief hindered referrals, even when monoclonal antibody doses were not scarce. Across practice settings, the most important facilitator for access to monoclonal antibodies was linkage of COVID-19 testing and treatment within care delivery. Although clinicians viewed monoclonal antibodies as safe and effective treatments for COVID-19, individual- and system-level barriers inhibited referrals, particular in some practice settings. Subcutaneous or oral formulations may overcome certain barriers to access, but simplifying patient access by linking testing with delivery of treatments that reduce morbidity and mortality will be critical for the ongoing response to COVID-19 and in future pandemics.

The Psychosocial Needs of Patients Participating in Diabetes Shared Medical Appointments.

BACKGROUND: Patient reported outcomes (PROs) for diabetes are self-reported and often give insight into outcomes important to people with diabetes. Federally Qualified Health Centers (FQHCs) see patients who may have higher levels of diabetes distress and lower levels of self-care behaviors. METHODS: The Invested in Diabetes study is a comparative effectiveness trial of diabetes Shared Medical Appointments (SMAs) in FQHCs and non-FQHC settings. PROs measure outcomes including validated measures on diabetes distress. SETTING AND PARTICIPANTS: 616 people from 22 practices completed PROs prior to SMAs. At FQHCs, participants were younger (average 57.7 years vs 66.9 years, p < 0.0001), more likely to be female (36.8% vs 46.1%, p = 0.02), and fewer spoke English (72.7% vs 99.6%, p < 0.0001). RESULTS: At FQHCs, diabetes distress was higher (2.1 vs 1.8, P = .02), more people were current smokers (14.3% vs 4.7%, P = .0002), on insulin (48.9% vs 22.3%, P < .0001) and reported food insecurity (52.7% vs 26.2%, P < .0001). After controlling for sociodemographic factors, these differences were nonsignificant. CONCLUSIONS: Higher numbers of patients at FQHCs report diabetes distress and food insecurity compared with patients in non-FQHC settings, indicating that patient social circumstances need to be considered as part of program implementation.

"All of the things to everyone everywhere": A mixed methods analysis of community perspectives on equitable access to monoclonal antibody treatment for COVID-19.

BACKGROUND: Neutralizing monoclonal antibody (mAb) treatment for COVID-19 prevents hospitalization and death but is underused, especially in racial/ethnic minority and rural populations. Reasons for underuse and inequity may include community member lack of awareness or healthcare access barriers, among others. This study assessed mAbs community awareness and opportunities for improving equitable mAb access. METHODS: A concurrent mixed methods study including surveys and focus groups with adults with high-risk conditions or their proxy decision-makers. Surveys and focus group guides addressed diffusion of innovation theory factors. Descriptive statistics and Fisher's exact method was used to report and compare survey findings by race and ethnicity. Rapid qualitative methods were used for focus group analysis. RESULTS: Surveys from 515 individuals (460 English, 54 Spanish, 1 Amharic), and 8 focus groups (6 English, 2 Spanish) with 69 participants, completed June 2021 to January 2022. Most survey respondents (75%) had heard little or nothing about mAbs, but 95% would consider getting mAb treatment. Hispanic/Latino and Non-Hispanic People of Color (POC) reported less awareness, greater concern about intravenous infusions, and less trust in mAb safety and effectiveness than White, Non-Hispanic respondents. Focus group themes included little awareness but high interest in mAb treatment and concerns about cost and access barriers such as lacking established sources of care and travel from rural communities. Focus groups revealed preferences for broad-reaching but tailored messaging strategies using multiple media and trusted community leaders. CONCLUSIONS: Despite unfamiliarity with mAb treatment, most respondents were open to receiving mAbs or recommending mAbs to others. While mAb messaging should have broad reach "to everyone everywhere," racial and geographic disparities in awareness and trust about mAbs underscore need for tailored messaging to promote equitable access. Care processes should address patient-level barriers like transportation, insurance, or primary care access. COVID-19 treatment dissemination strategies should promote health equity.

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.

Methods for capturing and analyzing adaptations: implications for implementation research.

BACKGROUND: Interventions are often adapted; some adaptations may provoke more favorable outcomes, whereas some may not. A better understanding of the adaptations and their intended goals may elucidate which adaptations produce better outcomes. Improved methods are needed to better capture and characterize the impact of intervention adaptations. METHODS: We used multiple data collection and analytic methods to characterize adaptations made by practices participating in a hybrid effectiveness-implementation study of a complex, multicomponent diabetes intervention. Data collection methods to identify adaptations included interviews, observations, and facilitator sessions resulting in transcripts, templated notes, and field notes. Adaptations gleaned from these sources were reduced and combined; then, their components were cataloged according to the framework for reporting adaptations and modifications to evidence-based interventions (FRAME). Analytic methods to characterize adaptations included a co-occurrence table, statistically based k-means clustering, and a taxonomic analysis. RESULTS: We found that (1) different data collection methods elicited more overall adaptations, (2) multiple data collection methods provided understanding of the components of and reasons for adaptation, and (3) analytic methods revealed ways that adaptation components cluster together in unique patterns producing adaptation "types." These types may be useful for understanding how the "who, what, how, and why" of adaptations may fit together and for analyzing with outcome data to determine if the adaptations produce more favorable outcomes rather than by adaptation components individually. CONCLUSION: Adaptations were prevalent and discoverable through different methods. Enhancing methods to describe adaptations may better illuminate what works in providing improved intervention fit within context. TRIAL REGISTRATION: This trial is registered on clinicaltrials.gov under Trial number NCT03590041 , posted July 18, 2018.