Clinical and microbiologic cure rates for NGU were somewhat low and there was no significant difference between azithromycin and doxycycline. Mycoplasma genitalium treatment failure was extremely common. Clinical Trials Registration.NCT00358462.

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BackgroundExiting a study early (dropout) may bias treatment effect estimates, while dropout and missing visits reduces study power. Simply increasing planned sample sizes cannot remove bias due to non‐ignorable missingness (Fleming, 2011). Preventing missing data is best (National Research Council, 2010). Hence, quantifying associations with missingness may identify ways to improve retention. Alzheimer’s disease (AD) clinical trials require study participation by a participant and study partner. Previous research examined dyadic retention in AD dementia trials (Grill et al., 2013; Bernstein, Grill & Gillen, 2021), yet less is understood in mild cognitive impairment (MCI) trials. Here, we examined MCI trial dropout rates and missingness patterns by dyad type.MethodWe performed retrospective analyses of the Alzheimer’s Disease Cooperative Study phase 3 MCI trial of donepezil and vitamin E. Scheduled study visits occurred at baseline, month 3, and semi‐annually until month 36. Study completion included the progression to a possible or probable AD diagnosis or month 36 visit. Dropout was withdrawal of consent or lost‐to‐follow‐up. Deaths and study completions were censored. Dyad types were spousal, adult child, or other. We estimated Kaplan‐Meier‐based dropout rates and summarized frequencies of on‐study missing visit patterns by baseline dyad type and stratified by randomized treatment (placebo, donepezil, vitamin E).ResultFigure 1 displays cumulative dropout rates by dyad type and treatment (panels A, B, C). Among 259 participants randomized to placebo, estimated study dropout rates were 24% for spousal, 16% for adult child, and 14% for other dyads. Table 1 summarizes on‐study missing visit patterns by dyad type and treatment; Figure 2 displays placebo data for specific patterns of missing data. While on study, 21% of spousal, 23% of adult child, and 27% of other dyads missed at least one scheduled visit, primarily monotonic missingness.ConclusionDyad type may be associated with some types of missingness in MCI clinical trials. Implementing dyad‐type‐specific strategies that encourage staying on study and attending all scheduled visits may improve retention, thus reducing bias, in future MCI trials.

Background: Dyadic enrollment of a participant and study partner is required in mild cognitive impairment (MCI) clinical trials, despite participants being functionally independent. Research examining how the study partner requirement impacts MCI trials remains limited. Methods: Using the Alzheimer’s Disease Cooperative Study donepezil and vitamin E MCI trial data, we quantified the proportions of enrolled spouse, adult child, and other dyads. We used multinomial regression to identify which baseline participant characteristics (age, sex, race and ethnicity, apolipoprotein E ε4 status, education, residence type) were associated with dyad type. Results: Among 769 randomized dyads, 73% were spousal, 14% adult child, and 13% other dyads. Adjusting for multiple comparisons, underrepresented racial and ethnic background (eg, comparing Hispanic to non-Hispanic White participants: adult child vs. spouse odds ratio = 5.86; 95% confidence interval: 2.09, 16.5; other vs. spouse odds ratio = 4.95; 95% confidence interval: 1.83, 13.4), female sex, age, nonhouse residence, and apolipoprotein E ε4 noncarriage were each associated with a higher odds of having an adult child, as well as an other, study partner at enrollment. Discussion: Increasing participation among nonspousal dyads may facilitate more inclusive and representative MCI trial samples.