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Contribution of contrast-enhanced ultrasound for diagnosis of adnexal torsion (COVARIAN): protocol for a randomised controlled trial

Por: Fijean · A.-L. · Manhertz · D. · Massicot · L. · Lecointre · L. · Mottet · N. · Raimond · E. · Simon · E. · Gabriele · V. · Morel · O. · Beaumont · M. · Hossu · G. · Bertholdt · C.
Introduction

Adnexal torsion is a gynaecological emergency in which prompt diagnosis and management are critical to preserving ovarian function. However, the clinical presentation is often non-specific, and diagnosis primarily relies on pelvic ultrasound, a modality with limited sensitivity that can lead to misdiagnosis and unnecessary surgery. Contrast-enhanced ultrasound (CEUS) has emerged as a promising imaging technique that may enhance diagnostic accuracy by better characterising adnexal vascularisation.

The aim of this study is to assess whether the addition of CEUS to standard diagnostic procedures can reduce the rate of unnecessary emergency surgeries. Specifically, we compare two diagnostic strategies in cases of high clinical suspicion of adnexal torsion: the current standard approach versus an experimental strategy incorporating CEUS. The primary outcome is the rate of inappropriate surgical interventions, defined as emergency surgery performed within 6 hours without intraoperative confirmation of torsion.

Methods and analysis

This is a prospective, open-label, multicentre, randomised (1:1), controlled, superiority trial. A total of 256 women presenting with a high clinical suspicion of adnexal torsion will be enrolled over a period of 36 months. Participants will be randomly assigned to either the standard diagnostic strategy or an experimental strategy that includes CEUS. The primary endpoint is the proportion of emergency surgical procedures (performed within 6 hours of hospital admission) in which adnexal torsion is not confirmed.

Ethics and dissemination

The study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) on 28 October 2024. The results of this study will be published in peer-reviewed journals and presented at relevant national and international conferences. The ethical approval number from the CPP is 6115.

Registration number

NCT06677554; 2024-511720-13-00.

Acute myocardial infarction diagnosis and treatment following implementation of a multicomponent intervention in Tanzania: the MIMIC pilot trial

Por: Hertz · J. T. · Nworie · J. E. · Shayo · F. · Galson · S. W. · Coaxum · L. A. · Daniel · I. · Makambay · P. S. · Akrabi · A. M. · Manyangu · G. J. · Thielman · N. M. · Bloomfield · G. · Sakita · F. M.
Background

In Tanzania, acute myocardial infarction (AMI) is underdiagnosed, and uptake of evidence-based care is suboptimal. Using an implementation science approach, an intervention was developed to address local barriers to care: the Multicomponent Intervention for Improving Myocardial Infarction Care in Tanzania (MIMIC).

Methods

This sequential cohort design trial was conducted in a single northern Tanzanian emergency department (ED). During the preintervention phase (February–August 2023) and the postintervention phase (September 2023–August 2024), adults presenting with chest pain and/or dyspnoea were prospectively enrolled and their ED care was observed. AMI was defined by the Fourth Universal Definition criteria. Telephone follow-ups were conducted to ascertain 30-day mortality. Pearson’s ² was used to compare care before and after MIMIC implementation.

Results

A total of 275 participants were enrolled in the preintervention phase and 577 were enrolled in the postintervention phase. Following MIMIC implementation, significant increases were observed in ECG testing (89.4% of postintervention participants vs 55.3% preintervention, OR 6.82, 95% CI 4.79 to 9.79, p

Conclusions

The MIMIC intervention was associated with large increases in uptake of AMI testing, case identification and evidence-based treatment in a single Tanzanian ED. Multisite studies are needed to evaluate the effect of MIMIC on AMI care in diverse settings across Tanzania.

Trial registration number

NCT04563546.

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