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Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol

Por: Ranard · B. L. · Qian · M. · Cummings · M. J. · Zhang · D. Y. · Lee · S. M. · Beitler · J. R. · Applebaum · J. R. · Schenck · E. J. · Mohamed · H. · Trepp · R. · Hsu · H. · Scofi · J. · Southern · W. N. · Rossetti · S. C. · Yip · N. H. · Brodie · D. · Sharma · M. · Fertel · B. S. · Adelman
Introduction

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving patient outcomes. International guidelines recommend hospital sepsis screening programmes, which are commonly implemented in the electronic health record (EHR) as an interruptive sepsis screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care.

Methods and analysis

The Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC) master protocol will study two distinct populations in separate trials: emergency department (ED) patients (SEPTIC-ED) and inpatients (SEPTIC-IP). The SEPTIC trials are pragmatic, multicentre, blinded, randomised controlled trials, with equal allocation to compare four SIRS-based sepsis screening alert groups: no alerts (control), nurse alerts only, prescribing clinician alerts only, or nurse and prescribing clinician alerts. Randomisation will be at the patient level. SEPTIC will be performed at eight acute-care hospitals in the greater New York City area and enrol patients at least 18 years old. The primary outcome is the percentage of patients with completion of a modified Surviving Sepsis Campaign (SSC) hour-1 bundle within 3 hours of the first SIRS alert. Secondary outcomes include time from first alert to completion of a modified SSC hour-1 bundle, time from first alert to individual bundle component order and completion, intensive care unit (ICU) transfer, hospital discharge disposition, inpatient mortality at 90 days, positive blood cultures (bacteraemia), adverse antibiotic events, sepsis diagnoses and septic shock diagnoses.

Ethics and dissemination

Ethics approval was obtained from the Columbia University Institutional Review Board (IRB) serving as a single IRB. Results will be disseminated in peer-reviewed journal(s), scientific meeting(s) and via social media.

Trial registration number

ClinicalTrials.gov: NCT06117605 and NCT06117618.

Exploring the sexual and reproductive health and rights policies and their relationship to the Termination of Pregnancy Act (1977) and bodily autonomy and integrity in Zimbabwe: a multimethod research protocol

Por: Nunu · W. N. · Sibindi · M. · Mantula · F. · Maviza · G. · Maphosa · M. · Ndzozi · P. · Gumbo · N. · Muparamoto · V. R. · Masiyambiri · F. · Ndlovu · M. · Nhorido · E. · Ndebele · S.
Introduction

In Zimbabwe, pregnancy termination is generally prohibited unless and only if the circumstances are in sync with the conditions stipulated in the Termination of Pregnancy (ToP) Act of 1977. This raises questions about the modern-day rights of bodily autonomy and integrity (BAI). Funded by the AIDS and Rights Alliance for Southern Africa, this study, therefore, seeks to review and analyse sexual and reproductive health and rights policies and how they relate to the ToP Act (1977) and BAI.

Methods and analysis

This study will use a concurrent multimethod approach. First, policies related to the ToP and bodily autonomy and integration will be reviewed and analysed using the policy analysis triangle. Concurrently, a qualitative and quantitative survey will be conducted on purposively selected key informants and focus group discussions with purposively selected women and men, as well as 200 stratified selected women. Qualitative findings will be recorded, transcribed and thematically analysed using MAXQDA V.20 Pro. Simultaneously, the quantitative output will be collected using KoboCollect, exported into Excel and analysed using both Excel and STATA. The strengths, weaknesses, opportunities and threats (SWOT) framework and the Basic Logic Model will guide the triangulation of the findings and development of a policy brief.

Ethics and dissemination

Ethical approval for this study was obtained from the National University of Science and Technology Institutional Review Board at Bulawayo, Zimbabwe (Ethics Number: NUST/IRB/2023/23). Written consent would also be sought from the participants. A policy brief would be developed and shared with key stakeholders. At least three manuscripts would emanate from this study and will be submitted for publication in reputable peer-reviewed journals.

Urinary cotinine cut-off concentrations in children under 5 years for assessing environmental tobacco smoke exposure: a systematic review and meta-analysis protocol

Por: Sayed Mohamed Zain · S. M. · Abdul Shukor · I. H. · Mohamad · N. · Wan Azmi · W. N. F. · Anual · Z. F.
Introduction

Environmental tobacco smoke (ETS) is generally known as secondhand smoke. Assessing the magnitude of children’s exposure to ETS from early infancy is essential for public health and research endeavours. Urinary cotinine is now widely recognised as the primary indicator for assessing exposure to ETS across all age groups. This systematic review and meta-analysis aim to synthesise all the published evidence on the urinary cotinine cut-off concentrations used to categorise children under 5 years as being exposed to ETS.

Methods and analysis

We will conduct a systematic review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. A comprehensive search will be conducted from various databases including PubMed, EMBASE, Scopus and Cochrane Library. This search will be performed from the earliest published articles up to the latest available studies until February 2025. We will include all the experimental and observational studies, such as cohort, case–control and cross-sectional, that measure urinary cotinine concentrations in children under 5 years old. Data extraction will be conducted using a standardised data extraction form, and the study quality will be evaluated according to the guidelines specified by the Newcastle-Ottawa Scale. The extracted data will be pooled and combined for meta-analysis. Two reviewers will independently screen, select and assess the quality of the included study. The result will be tabulated in a table of characteristics of the included study, which consists of the cut-off cotinine concentrations, analytical technique, method referred, study design, study area and respondents’ characteristics.

Ethics and dissemination

Ethics approval is not required as this is a review of collected published data. Findings will be disseminated in peer-reviewed publications and conference presentations, as well as with key stakeholders, health policymakers and healthcare professionals.

PROSPERO registration number

CRD42024556969.

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