Data analysis strategy
PTSS, cardiac fear and cardiac avoidance
SECONDARY, RECRUITMENT
Participant data were analyzed as randomized. For the primary outcomes of recruitment and retention at 30 days after the end of hospital care, as well as secondary outcomes of compliance with the intervention (write ≥ 2 times per week), compliance with study procedures (complete ≥ 90% of study assessments), and appropriateness, feasibility, and acceptability benchmarks (mean scale score ≥ 4), we computed the proportion of participants meeting these criteria and 95% confidence intervals around these proportions. Descriptive statistics for continuous appropriateness, feasibility, and acceptability scores are also reported.For additional outcomes of cardiac fear and cardiac avoidance, both at the end of hospital care as well as at 30 days after the end of hospital care, and for PTSS at 30 days after the end of hospital care, we conducted independent samples t-tests to compare scores in the intervention (diary) v. control group. Nonparametric Wilcoxon Rank Sum tests were conducted as sensitivity analyses. For PTSS, we additionally Chi-Square tests comparing proportion of intervention (diary) v. control group participants with a positive screen for clinically significant PTSS (scale score ≥ 33). All statistical tests for additional outcomes are considered exploratory and primarily descriptive because the FAID Fear pilot study was not powered to detect significant differences. Qualitative responses for intervention feedback are also described.Explicit permission from participants to post de-identified data online was not obtained; rather, participants consented that, “Upon removal of identifiers from the dataset, data may be shared with other researchers.” In accordance with recommendations for sharing raw clinical data for publication stating that it is ideal to obtain this consent [