Designing a Website to Support a Multisite, International Clinical Trial

Background Safe and reliable implementation of complex study protocols in multisite clinical trials requires that all study personnel have 24/7 access to up-to-date study materials. Study websites can serve as an electronic manual of operations (eMOO) to support trial conduct. Objective We describe the development, organization, and maintenance of a study website and eMOO to facilitate quick and efficient communication during conduct of a complex, multisite, international clinical trial. Methods We worked closely with our information technology department to develop and maintain our study website, which includes a public home page, a section for parents and families, and three password-protected portals that serve as an eMOO for (a) study sites, (b) study site investigators, and (c) the operations team (e.g., clinical coordination center, data coordination center). Results The public home page is helpful for families contemplating study participation and for nonparticipating sites considering joining our trial. The patient and family education section supports family participation in the study. The study site portal contains all information needed for local study teams to safely manage a study patient. The investigator portal provides access to research-specific materials needed to lead the study at each site. The operations team portal supports overall study management. For other scientists considering use of a study website for their multisite research, we recommend close collaboration with information technology for development and maintenance, limited and clearly defined roles for version control, and use of unmodifiable file formats to prevent unapproved alterations of study materials. Discussion Although investment in development and maintenance has been significant, we have appreciated marked value to our operations team and study sites. Our study website development process is relevant to other scientists conducting multisite clinical research.

Comparison of Weighting Methods to Understand Improved Outcomes Attributable to Public Health Nursing Interventions

Background The complex work of public health nurses (PHNs) specifically related to mental health assessment, intervention, and outcomes makes it difficult to quantify and evaluate the improvement in client outcomes attributable to their interventions. Objectives We examined heterogeneity across parents of infants served by PHNs receiving different interventions, compared the ability of traditional propensity scoring methods versus energy-balancing weight (EBW) techniques to adjust for the complex and stark differences in baseline characteristics among those receiving different interventions, and evaluated the causal effects of the quantity and variety of PHN interventions on client health and social outcomes. Methods This retrospective study of 4,109 clients used existing Omaha System data generated during the routine documentation of PHN home visit data. We estimated the effects of intervention by computing and comparing weighted averages of the outcomes within the different treatment groups using two weighting methods: (a) inverse probability of treatment (propensity score) weighting and (b) EBWs. Results Clients served by PHNs differed in baseline characteristics with clients with more signs/symptoms. Both weighting methods reduced heterogeneity in the sample. EBWs were more effective than inverse probability of treatment weighting in adjusting for multifaceted confounding and resulted in close balance of 105 baseline characteristics. Weighting the sample changed outcome patterns, especially when using EBWs. Clients who received more PHN interventions and a wider variety of them had improved knowledge, behavior, and status outcomes with no plateau over time, whereas the unweighted sample showed plateaus in outcomes over the course of home-visiting services. Discussion Causal analysis of PHN-generated data demonstrated PHN intervention effectiveness for clients with mental health signs/symptoms. EBWs are a promising tool for evaluating the true causal effect of PHN home-visiting interventions.

Study Recruitment, Retention, and Adherence Among Chinese American Immigrants During the COVID-19 Pandemic

Background Chinese American immigrants have been underrepresented in health research partly due to challenges in recruitment. Objectives This study aims to describe recruitment and retention strategies and report adherence in a 7-day observational physical activity study of Chinese American immigrants with prior gestational diabetes during the COVID-19 pandemic. Methods Foreign-born Chinese women aged 18–45 years, with a gestational diabetes index pregnancy of 0.5–5 years, who were not pregnant and had no current diabetes diagnosis were recruited. They wore an accelerometer for 7 consecutive days and completed an online survey. Multiple recruitment strategies were used: (a) culturally and linguistically tailored flyers, (b) social media platforms (e.g., WeChat [a popular Chinese platform] and Facebook), (c) near-peer recruitment and snowball sampling, and (d) a study website. Retention strategies included flexible scheduling and accommodation, rapid communications, and incentives. Adherence strategies included a paper diary and/or automated daily text reminders with a daily log for device wearing, daily email reminders for the online survey, close monitoring, and timely problem-solving. Results Participants were recruited from 17 states; 108 were enrolled from August 2020 to August 2021. There were 2,479 visits to the study webpage, 194 screening entries, and 149 inquiries about the study. Their mean age was 34.3 years, and the mean length of U.S. stay was 9.2 years. Despite community outreach, participants were mainly recruited from social media (e.g., WeChat). The majority were recruited via near-peer recruitment and snowball sampling. The retention rate was 96.3%; about 99% had valid actigraphy data, and 81.7% wore the device for 7 days. The majority of devices were successfully returned, and the majority completed the online survey on time. Discussion We demonstrated the feasibility of recruiting and retaining a geographically diverse sample of Chinese American immigrants with prior gestational diabetes during the COVID-19 pandemic. Recruiting Chinese immigrants via social media (e.g., WeChat) is a viable approach. Nonetheless, more inclusive recruitment strategies are needed to ensure broad representation from diverse socioeconomic groups of immigrants.

Realist Approach to Qualitative Data Analysis

Background A realist approach has gained popularity in evaluation research, particularly in understanding causal explanations of how a program works (or not), the circumstances, and the observed outcomes. In qualitative inquiry, the approach has contributed to better theoretically based explanations regarding causal interactions. Objective The aim of this study was to discuss how we conducted a realist-informed data analysis to explore the causal interactions within qualitative data. Methods We demonstrated a four-step realist approach of retroductive theorizing in qualitative data analysis using a concrete example from our empirical research rooted in the critical realism philosophical stance. These steps include (a) category identification, (b) elaboration of context-mechanism-outcome configuration, (c) demi-regularities identification, and (d) generative mechanism refinement. Results The four-step qualitative realist data analysis underpins the causal interactions of important factors and reveals the underlying mechanisms. The steps produce comprehensive causal explanations that can be used by related parties—especially when making complex decisions that may affect wide communities. Discussion The core process of realist data analysis is retroductive theorizing. The four-step qualitative realist data analysis facilitates this theorizing by allowing the researcher to identify (a) patterns, (b) fluctuation of patterns, (c) mechanisms from collected data, and (d) to confirm proposed mechanisms.