Evidence of secular trends during the COVID-19 pandemic in a stepped wedge cluster randomized trial examining sexual and reproductive health outcomes among Indigenous youth.

BACKGROUND: Nen UnkUmbi/EdaHiYedo ("We Are Here Now," or NE) is an intervention to prevent STIs, HIV, HCV, and teen pregnancy among Assiniboine and Sioux youth of the Fort Peck Reservation in the state of Montana in the USA. A cluster-randomized stepped-wedge design (SWD) trial is used to evaluate NE, where clusters are schools. The purpose of this study is to evaluate whether there is evidence of a secular trend associated with the COVID-19 pandemic. METHODS: The original study design is a cluster-randomized stepped-wedge design (SWD), in which five schools that youth from Fort Peck attend are the clusters to be randomized into the intervention one at a time, with all schools eventually being randomized to the intervention across three steps. N/E is a 5-year study involving 456 15- to 18-year-old youth. For this study, we use a mixed quantitative and qualitative methods approach to understand how the COVID-19 pandemic may have been associated with the study's primary outcome variables. Data were drawn from the first cluster exposed to the intervention and one control cluster that did not yet receive the intervention during the period in which COVID-19 mitigation efforts were being implemented. A pre-post COVID questionnaire was added to core measures administered, and semistructured qualitative interviews were conducted with youths regarding their perceptions of how the pandemic altered their sexual behaviors. RESULTS: One hundred eighteen youth responded to the questionnaire and 31 youth participated in semistructured qualitative interviews. Youth reporting having sex with less people due to COVID-19 reported more sex acts (incident rate ratio (IRR)=3.6, 95% CI 1.6-8.1) in comparison to those who did not report having sex with less people, and youth who reported having sex with the same amount of people due to COVID-19 reported less sex acts (IRR=0.31, 95% CI 0.14-0.7) in comparison to those who did not report having sex with the same amount of people. Youth reporting having sex less times due to COVID-19 experienced a greater number of sex acts in comparison to those who did not report having sex less times (IRR=2.7, 1.2-6.4). Results suggest that more sexually active individuals reported perceiving having sex with less people and less frequent engagement in sex during the pandemic. It is possible that the COVID-19 pandemic period was associated with a truncation in the distribution of sexual activity that would bias an estimate of the intervention's effect. CONCLUSION: Findings suggest evidence of a secular trend. This trend must be accounted for at trial end, and sensitivity analyses are recommended. Documenting and reporting on these findings encourages transparent reporting during the implementation of a SWD trial during a global pandemic, and informs endline analyses. TRIAL REGISTRATION: This trial is registered with the Clinical trials registry of the US National Library of Medicine at the National Institutes of Health (NIH). It was registered on October 1, 2018. The study presented in this manuscript is funded by NIH National Institute on Minority Health and Health Disparities (NIMHD), Award # R01MD012761-01, Elizabeth Rink (Principal Investigator). The study's ClinicalTrials.gov number is NCT03694418.

Adaptations Due to the COVID-19 Pandemic in a Community-Based Participatory Research Randomized Control Trial Examining Sexual and Reproductive Health Outcomes among American Indian Youth.

In this manuscript, we present changes in study design and analytical strategy due to the COVID-19 pandemic for Nen UnkUmbi/EdaHiYedo ("We Are Here Now," or NE). NE is a community-based participatory research multi-level randomized control trial using a stepped wedge design to address sexual and reproductive health disparities among American Indian youth. Adaptations in NE's research design, data collection, and analysis due to the COVID-19 pandemic were made based on meetings with tribally based research team members and outside non-Indigenous researchers involved in NE, as well as the study's Community Advisory Board and the Data Safety Monitoring Board. Based on these iterative discussions, decisions were made to: 1) reorganize the sequence of NE's stepped wedge design clusters, and 2) include additional quantitative and qualitative data collection and analysis in the research design that specifically addressed the impact of COVID-19 on the research participants. These adaptations have the potential to foster greater scientific knowledge in understanding how to address unanticipated 3-way interaction effects in randomized control trials with tribal communities. Findings can also contribute to understanding how public health disasters impact sexual and reproductive health among American Indian youth.

An Online Weight Loss Intervention for People With Obesity and Poorly Controlled Asthma.

BACKGROUND: Weight loss might improve asthma control in people with obesity. However, people with asthma might have particular challenges losing weight and the amount of weight loss needed to improve asthma control is not clear. OBJECTIVES: To pilot-test an online weight loss intervention and to estimate the impact of weight loss on asthma control. METHODS: We performed a 6-month, single-arm, futility trial of an online weight loss intervention at 2 centers. To reject the assumption of futility, 9 or more participants had to lose at least 5% of their body weight. We also assessed the association between weight loss (≥5%) and asthma outcomes. RESULTS: Forty-three participants (85% women) started the weight loss intervention. The median and interquartile range for the body mass index was 40.3 kg/m2 (range 34.7-46.8 kg/m2), and 14 (range 12-17 kg/m2) for the Asthma Control Test score. At 6 months, 10 participants (23%; 95% CI 12%-39%) lost at least 5% of their initial weight. Weight loss of at least 5% was associated with a clinically and statistically significant improvements in their Asthma Control Test (median [interquartile range] increase of 3 [1 to 7]; P < .05), Marks Asthma Quality of Life Score (-9.5 [-18 to -3]; P = .008), and their general health-related quality of life score (RAND-36; improved by 9.4 [2.8 to 22.5]; P =.014). CONCLUSIONS: An online weight loss intervention has the potential to meet U.S. Food and Drug Administration guidance for product evaluation (at least a 5% weight loss in 35% of people) for treating obesity, and is associated with a clinically significant improvement in asthma control, quality of life, and overall health-related quality of life.

Prospective study of emergency medicine provider wellness across ten academic and community hospitals during the initial surge of the COVID-19 pandemic.

BACKGROUND: While COVID-19 has had far-reaching consequences on society and health care providers, there is a paucity of research exploring frontline emergency medicine (EM) provider wellness over the course of a pandemic. The objective of this study was to assess the well-being, resilience, burnout, and wellness factors and needs of EM physicians and advanced practice providers (e.g., nurse practitioners and physician assistants; APPs) during the initial phase of the COVID-19 pandemic. METHODS: A descriptive, prospective, cohort survey study of EM physicians and APPs was performed across ten emergency departments in a single state, including academic and community settings. Participants were recruited via email to complete four weekly, voluntary, anonymous questionnaires comprised of customized and validated tools for assessing wellness (Well Being Index), burnout (Physician Work Life Study item), and resilience (Brief Resilience Scale) during the initial acceleration phase of COVID-19. Univariate and multivariate analysis with Chi-squared, Fisher's Exact, and logistic regression was performed. RESULTS: Of 213 eligible participants, response rates ranged from 31 to 53% over four weeks. Women comprised 54 to 60% of responses. Nonrespondent characteristics were similar to respondents. Concern for personal safety decreased from 85 to 61% (p < 0.001). Impact on basic self-care declined from 66 to 32% (p < 0.001). Symptoms of stress, anxiety, or fear was initially 83% and reduced to 66% (p = 0.009). Reported strain on relationships and feelings of isolation affected > 50% of respondents initially without significant change (p = 0.05 and p = 0.30 respectively). Women were nearly twice as likely to report feelings of isolation as men (OR 1.95; 95% CI 1.82-5.88). Working part-time carried twice the risk of burnout (OR, 2.45; 95% CI, 1.10-5.47). Baseline resilience was normal to high. Provider well-being improved over the four weeks (30 to 14%; p = 0.01), but burnout did not significantly change (30 to 22%; p = 0.39). CONCLUSION: This survey of frontline EM providers, including physicians and APPs, during the initial surge of COVID-19 found that despite being a resilient group, the majority experienced stress, anxiety, fear, and concerns about personal safety due to COVID-19, putting many at risk for burnout. The sustained impact of the pandemic on EM provider wellness deserves further investigation to guide targeted interventions.

Longitudinal Prospective Study of Emergency Medicine Provider Wellness Across Ten Academic and Community Hospitals During the Initial Surge of the COVID-19 Pandemic.

Background: While the coronavirus (COVID-19) has had far-reaching consequences on society and health care providers, there is a paucity of research exploring emergency medicine (EM) provider wellness over the course of a pandemic. The objective of this study was to assess the well-being, resilience, burnout, and wellness factors and needs of EM physicians and advanced practice providers (APPs) during the initial phase of the COVID-19 pandemic. Methods: A longitudinal, descriptive, prospective cohort survey study of 213 EM physicians and APPs was performed across ten emergency departments in a single state, including academic and community settings. Participants were recruited via email to complete four weekly, voluntary, anonymous questionnaires comprised of customized and validated tools for assessing wellness (Well Being Index), burnout (Physician Work Life Study item), and resilience (Brief Resilience Scale) during the initial acceleration phase of COVID-19. Univariate and multivariate analysis with Chi-squared, Fisher’s Exact, and logistic regression was performed. Results: Of 213 eligible participants, response rates ranged from 31 to 53% over four weeks. Women comprised 54 to 60% of responses. Nonrespondent characteristics were similar to respondents. Concern for personal safety decreased from 85% to 61% (p<0.001). Impact on basic self-care declined from 66% to 32% (p<0.001). Symptoms of stress, anxiety or fear was initially 83% and reduced to 66% (p=0.009). Reported strain on relationships and feelings of isolation affected >50% of respondents initially without significant change (p=0.05 and p=0.30 respectively). Women were nearly twice as likely to report feelings of isolation as men (OR 1.95; 95%CI 1.82-5.88). Working part-time carried twice the risk of burnout (OR, 2.45; 95% CI, 1.10-5.47). Baseline resilience was normal to high. Provider well-being improved over the four-weeks (30% to 14%; p=0.01), but burnout did not significantly change (30% to 22%; p=0.39). Conclusion: This survey of frontline EM providers during the initial surge of COVID-19 found that despite being a resilient group, the majority experienced stress, anxiety, fear, and concerns about personal safety due to COVID-19, with many at risk for burnout. The sustained impact of the pandemic on EM provider wellness deserves further investigation to guide targeted interventions.