Pignolo, Robert

Abstract Background/Objective: Decentralized research has many advantages; however, little is known about the representativeness of a source population in decentralized studies. We recruited participants aged 18-64 years from four states from June to December 2022 for a prospective cohort study to assess viral epidemiology. Our aim was to determine the association between age, gender, race/ethnicity, rurality, and socioeconomic status (SES) on study participation in a decentralized prospective cohort study. Methods: We consented 9,286 participants from 231,099 (4.0%) adults with the mean age of 45.6 years (±12.0). We used an electronic decentralized approach for recruitment. Consented participants were more likely to be non-Hispanic White, female, older, urban residents, have more health conditions, and possessed higher socioeconomic status (SES) compared to those non-consented. Results: We observed an interaction between SES and race-ethnicity on the odds of consent (P = 0.006). Specifically, SES did not affect non-Hispanic white participation rates(OR 1.24 95% CI 1.16 – 1.32] for the highest SES quartile compared to those with the lowest SES quartile) as much as it did participants combined across the other races (OR 1.73; 95% CI 1.45 – 2.98]) Conclusion: The relationship between SES and consent rates might be disproportionately greater in historically disadvantaged groups, compared to non-Hispanic White. It suggests that instead of focusing on enrollment of specific minority groups in research, there is value in future research exploring and addressing the diversity of barriers to trials within minority groups. Our study highlights that decentralized studies need to address social determinants of health, especially in under-resourced populations.

AbstractBackground and AimsInfluenza is a challenging infectious illness for older adults. It is not completely clear whether influenza is associated with frailty or functional decline. We sought to determine the association between incident influenza infection and frailty and prefrailty in community patients over 50 years of age. We also investigated the association between influenza vaccination and frailty and prefrailty as a secondary aim.MethodsThis was a prospective community cohort study from October 2019 to November 2020 in participants over 50 years. The primary outcome was the development of frailty as defined by three of five frailty criteria (slow gait speed, low grip strength, 5% weight loss, low energy, and low physical functioning). The primary predictor was a positive polymerase chain reaction (PCR) for influenza infection. Influenza vaccination was based on electronic health record reviewing 1 year before enrollment. We reported the relationship between influenza and frailty by calculating odds ratios (OR) with 95% confidence intervals (CI) after adjustment for age, sex, socioeconomic status, Charlson Comorbidity Index (CCI), influenza vaccine, and previous self‐rated frailty from multinomial logistic regression model comparing frail and prefrail to nonfrail subjects.ResultsIn 1135 participants, the median age was 67 years (interquartile range 60−74), with 41% men. Eighty‐one participants had PCR‐confirmed influenza (7.1%). Frailty was not associated with influenza, with an OR of 0.50 (95% CI 0.17−1.43) for frail participants compared to nonfrail participants. Influenza vaccination is associated with frailty, with an OR of 1.69 (95% CI 1.09−2.63) for frail compared to nonfrail. Frailty was associated with a higher CCI with an OR of 1.52 (95% CI 1.31−1.76).ConclusionWe did not find a relationship between influenza infection and frailty. We found higher vaccination rates in participants with frailty compared to nonfrail participants While influenza was not associated with frailty, future work may involve longer follow‐up.