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.

A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test—called the Genital InFlammation Test (GIFT)—for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care.

We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical (‘diagnostic study’) and a qualitative, modelling and economic (‘an integration into care study’) part. The diagnostic study aims to evaluate GIFT’s performance in identifying asymptomatic women with discharge-causing STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms.

Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.

The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d’Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).

Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484).

NCT05723484.

This scoping review maps the extant literature on students’ and graduates’ mental health experiences throughout their university-to-work transitions. The current review investigates the methodological features of the studies, the main findings, and the theories that the studies draw on to conceptualise mental health and transitions.

This project used a scoping review methodology created and developed by Peters and colleagues and the Joanna Briggs Institute. The review searched academic databases and screened existing studies that met predetermined inclusion criteria.

Seven academic databases and Google Scholar were searched with sets of search terms.

The included studies examined participants who were final-year university students or those who had graduated from university within a 3-year period. Studies published in English since 2000 and from any country were included. The review included studies examining the negative dimensions of mental health. The review excluded studies focusing on medical students and graduates.

Basic information about the studies and their findings on mental health and university-to-work transitions was retrieved. The findings are presented in tables and in a qualitative thematic summary.

The scoping review included 12 studies. Mental health was often not explicitly defined and it’s theoretical foundations were not clearly articulated. The review identified factors, including a lack of social support and economic precarity, as sources of adverse mental health. Other protective factors in these studies—variables that guard against mental health problems—were identified, such as career preparedness and having a good job.

Despite the methodological focus on the negative aspects of mental health, people’s mental health experiences during university-to-work transitions are not uniformly negative. Clear conceptualisations of mental health in future studies will aid in developing resources to improve well-being.

This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/gw86x).

Individuals with sickle cell disease (SCD) and central venous catheters (CVC) are at high risk for venous thromboembolism (VTE). Minimal data exist regarding the use of anticoagulation as thromboprophylaxis of VTE in this demographic, and as a result, clinical equipoise exists. Prophylactic dose rivaroxaban, a direct oral anticoagulant, is efficacious and safe as thromboprophylaxis in other demographics, and may be an optimal agent in SCD with CVC. Prior to conducting a full clinical trial to assess rivaroxaban as thromboprophylaxis in SCD with CVC, a pilot study is needed to gauge its feasibility.

THromboprophylaxis In Sickle Cell Disease pilot trial is an investigator-initiated, multicentre, double-blinded, randomised controlled trial (RCT) assessing if it is feasible and safe to conduct an adequately powered RCT comparing rivaroxaban to matching placebo as thromboprophylaxis in those with SCD and CVC. Fifty adult patients with SCD and CVC will be randomised to receive either rivaroxaban 10 mg daily or matching placebo for the duration of the CVC in situ for up to 1 year. After randomisation, follow-up visits will occur every 3 months. The primary outcomes pertain to the feasibility of a full trial and include numbers of eligible and recruited participants. Exploratory outcomes include overall incidence of VTE and bleeding complications, as well as quality of life. If the full trial is feasible, blinding will be maintained and patients in the pilot study will be included in the full trial.

The trial was initially approved by the University Health Network Research Ethics Board (REB) in Toronto, Canada. All sites will obtain approval from their respective REB prior to commencement of study activities. Study results will be disseminated through presentations at medical conferences and peer-reviewed publications.

NCT05033314.

SARS-CoV-2 has impacted globally the care of chronic diseases. However, direct evidence from certain vulnerable communities, such as Indigenous communities in Latin America, is missing. We use observational data from a health district that primarily serves people of Maya K’iche’ ethnicity to examine the care of type 2 diabetes in Guatemala during the pandemic.

We used a parallel convergent mixed methods design. Quantitative data (n=142 individuals with diabetes) included glycated haemoglobin (HbA1c), blood pressure, body mass index and questionnaires on diabetes knowledge, self-care and diabetes distress. Quantitative data was collected at two points, at baseline and after COVID restrictions were lifted. For quantitative outcomes, we constructed multilevel mixed effects models with multiple imputation for missing data. Qualitative data included interviews with providers, supervisors and individuals living with diabetes (n=20). We conducted thematic framework analysis using an inductive approach.

Quantitative data was collected between June 2019 and February 2021, with a median of 487 days between data collection points. HbA1c worsened +0.54% (95% CI, 0.14 to 0.94) and knowledge about diabetes decreased –3.54 points (95% CI, –4.56 to –2.51). Qualitatively, the most important impact of the pandemic was interruption of the regular timing of home visits and peer group meetings which were the standard of care.

The deterioration of diabetes care was primarily attributed to the loss of regular contact with healthcare workers. The results emphasize the vulnerability of rural and Indigenous populations in Latin America to the suspension of chronic disease care.

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.