COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic.

BACKGROUND: This survey of COVID-19 interventional studies encompasses, and expands upon, a previous publication [1] examining individual participant level data (IPD) sharing intentions for COVID-related trials and publications prior to June 30, 2020. METHODS: Replicating our inclusion criteria from the original survey, we evaluated a larger dataset of 2759 trials and 281 publications in this follow-up survey for willingness to share IPD and studied if sharing sentiment has evolved since the beginning of the pandemic. RESULTS: We found that 18 months into the pandemic, data sharing intentions remained static at 15% for trials registered through ClinicalTrials.gov (ClinicalTrials.gov is a digital registry of information about publicly and privately funded clinical studies in which human volunteers participate in interventional or observational scientific research) prior to September 19, 2021 compared to our initial survey. However, a comparison of declared intentions to share IPD at the time of publication revealed a noticeable shift: affirmative intentions grew from 21.4% (6/28) in our original publications survey to 57% (160/281) in this survey. Within the subset of studies published within journals affiliated with the International Committee of Medical Journal Editors (ICMJE), positive sharing intentions are even higher (65%). CONCLUSIONS: Although intent to share data at the time of registration has not changed from our prior study in June 2020, there is growing commitment to sharing data reflected in the increasing number of affirmative declarations at the time of publication. Actual sharing of data will accelerate new insights into COVID-19 through secondary re-use of data.

Implementing empowerment-based Lay Health Worker programs: a preliminary study.

Lay Health Worker (LHW) programs have been shown to be effective in engaging community members in health promotion. While successful LHW program implementation requires an understanding of factors influencing program effectiveness, evidence informing such understanding is lacking for empowerment and ecological theory-based LHW programs. This descriptive study explores how enablers and barriers, identified from LHW literature apply (from the LHWs' perspective) in the context of implementing an empowerment and ecological theory-based LHW model in Melbourne, Victoria. A qualitative case study was carried out. Data were collected from participating LHWs (n = 11) via anonymized online activity logs (n = 7) and semi-structured interviews (n = 7). Deductive-inductive thematic analysis was guided by five a priori themes identified from the literature: community relationships; intrinsic traits, values and motivations; capacity building; program design; and work conditions. Data supported the enablers and barriers to program effectiveness and implementation reported by previous research. Subthemes identified the importance of the LHW bridging role; the empowerment model; integrating the program; and program inclusiveness. This research contributes to the growing practice literature regarding how to effectively implement diverse LHW models in diverse settings. It also contributes to social ecological and complex systems-based health promotion practice evidence in suggesting LHWs to be potentially useful elements which may add to the effectiveness of ecologically based health promotion interventions.