To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.

Systematic review.

We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.

Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.

4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.

We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).

Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.

CRD42022282565.

We aimed to provide a region-wide comprehensive account of the indirect effects of COVID-19 on patients with chronic disease, in terms of non-COVID-19 mortality, and access to both inpatient and outpatient health services over a 2-year pandemic period.

Population-based retrospective study.

Adult patients, affected by at least 1 of 32 prevalent chronic conditions, residing in the Emilia-Romagna Region in Italy, during the years 2020 (N=1 791 189, 47.7% of the overall adult regional population) and 2021 (N=1 801 071, 47.8%).

Overall, non-COVID-19 mortality among patients with chronic disease during the pandemic (2.7%) did not differ substantially from the expected mortality (2.5%), based on a 3 years prepandemic period (2017–2019) and adjusting for the demographic and clinical characteristics of the population under study. Indeed, while the first pandemic wave was characterised by a significant non-COVID-19 excess mortality (March: +35%), the subsequent phases did not show such disruptive variations in non-COVID-19 deaths, which remained around or even below the excess mortality threshold. End-of-life care of patients with chronic disease, especially for non-COVID-19 cases, significantly shifted from hospitalisations (–19%), to homecare (ADI: +7%; w/o ADI: +9%). Overall, healthcare of patients without COVID-19 chronic disease decreased, with similar negative trends in hospitalisations (–15.5%), major procedures (–19.6%) and ER accesses (–23.7%). Homecare was the least affected by the pandemic, with an overall reduction of –9.8%. COVID-19 outbreak also impacted on different types of outpatient care. Rehabilitation therapies, specialist visits, diagnostic and lab tests were considerably reduced during the first pandemic wave and consequent lockdown, with access rates of patients without COVID-19 chronic disease below –60%.

This work thoroughly describes how a large and well-defined population of patients without COVID-19 chronic disease has been affected by the changes and reorganisation in the healthcare system during 2 years of the pandemic, highlighting health priorities and challenges in chronic disease management under conditions of limited resources.