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.

Lessons on Resilient Research: Adapting the Tribal Turning Point Study to COVID-19.

Tribal Turning Point (TTP) is a community-based randomized controlled trial of a lifestyle intervention to reduce risk factors for type 2 diabetes in Native youth. TTP began in 2018 and was interrupted by the COVID-19 pandemic in 2020. In this paper we aimed to understand 1) how the pandemic impacted TTP's operations, and how the TTP team successfully adapted to these impacts; 2) how the effects of COVID-19 and our adaptations to them were similar or different across TTP's research sites; and 3) lessons learned from this experience that may help other Native health research teams be resilient in this and future crises. Using a collaborative mixed methods approach, this report explored five a priori domains of adaptation: intervention delivery, participant engagement, data collection, analytic strategies, and team operations. We derived three lessons learned: 1) ensure that support offered is flexible to differing needs and responsive to changes over time; 2) adapt collaboratively and iteratively while remaining rooted in community; and 3) recognize that relationships are the foundation of successful research.

Adherence to Screening Among American Indian Women Accessing a Mobile Mammography Unit.

RATIONALE AND OBJECTIVES: Although screening mammography is essential to reducing breast cancer morbidity and mortality, barriers exist especially among underrepresented minority groups. There are few studies of mammogram screening among American Indian women, many of whom reside in rural areas where screening access is challenging. A mobile mammography unit served 24 Indian Health Service clinics during 2013-17. Screening mammography adherence was evaluated. MATERIALS AND METHODS: Among mobile unit women, 'adherence to screening' was determined by the date of the most recent prior mammogram. Those having a prior mammogram 9-27 months ago were classified as 'adherent to screening'. Comparison screening data were obtained from the American College of Radiology National Mammography Database, consisting of screening cases occurring in year 2015. Additionally, among mobile unit women 'continued adherence to screening' was determined, defined as at least one repeat screening at the mobile unit within the subsequent 9-27 months after a screening there. RESULTS: Among 1,615 mobile unit women, 624 (38.6%) were adherent to screening. Among 2,509,826 National Mammography Database women, 1,481,021 (59.0%) were adherent to screening. (p<0.0001) The prevalence of a >27-month interval between mammograms was 3.13 (95% CI 2.91-3.36) times greater among mobile unit women than National Mammography Database women. 'Continued adherence to screening' of mobile unit women was 428/1194 (35.9%). CONCLUSION: Adherence to screening and continued adherence to screening were low among mobile unit women and time interval between screenings was longer than National Mammography Database women. Factors to improve screening adherence among these underserved women should be determined.

Impact of trial design and patient heterogeneity on the identification of clinically effective therapies for progressive MS.

Clinically effective immunomodulatory therapies have been developed for relapsing-remitting multiple sclerosis (RRMS), but they have generally not translated to a corresponding slowing of disability accumulation in progressive forms of multiple sclerosis (MS). Since disability is multifaceted, progressive patients are heterogeneous, and the drivers of disease progression are still unclear, it has been difficult to identify the most informative outcome measures for progressive trials. Historically, secondary outcome measures have focused on inflammatory measures, which contributed to the recent identification of immunomodulatory therapies benefiting younger patients with more inflammatory progressive MS. Meanwhile, agents capable of treating late-stage disease have remained elusive. Consequently, measures of neurodegeneration are becoming common. Here, we review completed clinical trials testing immunomodulatory therapies in primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS) and discuss the features contributing to trial design variability in relation to trial outcomes, and how efforts toward better patient stratification and inclusion of reliable progression markers could improve outcomes.

Availability of prior mammograms affects incomplete report rates in mobile screening mammography.

PURPOSE: Mobile mammography can improve access to screening mammography in rural areas and underserved populations. We evaluated the frequency of incomplete reports in mobile mammography screening and the relationships between prior mammograms and recall rates. METHODS: The frequency of incomplete mammogram reports, the subgroups of those needing prior comparison mammograms, recalls for additional imaging, and availability of prior mammograms of a mobile screening mammography unit were compared with fixed site mammography from January 1, 2007 through December 31, 2009. All mobile unit mammograms were full field digital mammography (FFDM). Differences between rates of recall, incomplete reports, and availability of prior mammograms were calculated using the Chi-Square statistic. RESULTS: Of 2640 mobile mammography cases, 21.9% (578) reports were incomplete, versus 15.2% (7653) (p ≤ 0.001) of 50325 fixed site reports. Of incomplete cases, recall for additional imaging occurred among 8.3% (218) of mobile mammography reports versus 11.3% (5708) (p ≤ 0.001) of fixed site reports. Prior mammograms were needed among 13.6% (360) of mobile mammography versus 3.9% (1945) (p ≤ 0.001) of fixed site reports. Mobile mammography recall rate varied with availability of prior mammograms: 16.0% (54) when no prior mammograms, 7.6% (127) when prior mammograms were elsewhere but unavailable and 5.9% (37) when prior FFDM were immediately available (p ≤ 0.001). CONCLUSIONS: Incomplete reports were more frequent in mobile mammography than the fixed site. The availability of prior comparison mammograms at time of interpretation decreased the rate of incomplete mammogram reports. Recall rates were higher without prior comparison mammograms and lowest when comparison FFDM mammograms were available.