The Diversity of Research Participants in Randomized Controlled Trials and Observational Studies Conducted by the Canadian Critical Care Trials Group.

Rationale: Women, older individuals, and racial and ethnic minority groups are often underrepresented in research studies. Objectives: We evaluated the demographics and diversity of participants enrolled in randomized controlled trials (RCTs) and observational studies published by investigators in association with the Canadian Critical Care Trials Group. Methods: We performed quantitative content analysis of peer-reviewed RCTs and observational studies from December 1994 to December 2022. For each publication, we extracted participant demographic variables, including sex, gender, age, race or ethnicity, sexual orientation, pregnancy status, language proficiency, income/financial status, housing, education, disability, and geography. Results: A total of 120 publications (28 RCTs, 92 observational studies) included 211,144 enrolled participants. Most (107 of 120; 89.2%) were multicenter studies, and 70% (84 of 120) were conducted exclusively in Canadian centers; 77.5% (93 of 120) studies enrolled adult participants, and 19.2% (23 of 120) enrolled pediatric participants. All studies reported participant mean or median age, 118 (98.3%) reported binary sex or gender, and 9 (7.5%) reported race or ethnicity. No justification was provided in 35 studies that listed pregnancy as an exclusion. There was infrequent reporting of housing (n = 4), employment (n = 2), income (n = 2), and education (n = 1). No studies reported the language proficiency, sexual orientation, disability, or geography of participants. Of the studies reporting gender, women and/or girls comprised 42.3% participants (range, 8.9-67.7%). Within nine studies reporting race or ethnicity of 2,950 participants, 59.7% were White, 8% South Asian, 7% Indigenous, 3% Asian, 1% Black, 14% unknown, and 6% "other." Conclusions: Research publications from the Canadian Critical Care Trials Group infrequently report important participant demographics, and diversity of research participants is disproportionate compared with Canadian societal demographics.

Association Between Cirrhosis and 30-Day Rehospitalization After Index Hospitalization for Heart Failure.

There are limited data on clinical outcomes in patients re-admitted with decompensated heart failure (HF) with concomitant liver cirrhosis. We conducted a cross sectional analysis of the Nationwide Readmissions Database (NRD) years 2010 thru 2012. An Index admission was defined as a hospitalization for decompensated heart failure among persons aged ≥ 18 years with an alive discharge status. The main outcome was 30 - day all-cause rehospitalization. Survey logistic regression provided the unadjusted and adjusted odds of 30 - day rehospitalization among persons with and without cirrhosis, accounting for age, gender, kidney dysfunction and other comorbidities. There were 2,147,363 heart failure (HF) hospitalizations among which 26,156 (1.2%) had comorbid cirrhosis. Patients with cirrhosis were more likely to have a diagnosis of acute kidney injury (AKI) during their index hospitalization (18.4% vs 15.2%). There were 469,111 (21.9%) patients with readmission within 30 - days. The adjusted odds of a 30 - day readmission was significantly higher among patients with cirrhosis compared to without after adjusting for comorbid conditions (adjusted Odds Ratio [aOR], 1.3; 95% Confidence Interval [CI}: 1.2 to 1.4). The relative risk of 30 - day readmission among those with cirrhosis but without renal disease (aOR, 1.3; 95% CI: 1.3 to 1.3) was lower than those with both cirrhosis and renal disease (aOR, 1.8; 95% CI: 1.6 to 2.0) when compared to persons without either comorbidities. Risk of 30 - day rehospitalization was significantly higher among patients with heart failure and underlying cirrhosis. Concurrent renal dysfunction among patients with cirrhosis hospitalized for decompensated HF was associated with a greater odds of rehospitalization.