Objectives: Stepped wedge cluster randomized trials (SW-CRTs) are an appealing study design because they enable sequential roll out of an intervention across clusters, bringing logistical advantages. This review aimed to evaluate the design rationale, design features, stepped wedge diagram, and analytical approaches of SW-CRTs published in high-impact medical journals from 2020 to 2023, focusing particularly on adherence to key guidelines from the Consolidated Standards of Reporting Trials extension to SW-CRTs.
Study Design And Setting: We conducted searches across PubMed and Cochrane Central Registry of Controlled Trials databases for SW-CRTs published between January 2020 and December 2023 in eight high-impact journals.
Aim: To extend the findings of a previous clinical trial suggesting combined abacavir (ABC), lamivudine (3TC), and zidovudine (AZT) reduces type I interferon (IFN) signalling in Aicardi-Goutières syndrome (AGS).
Method: This was an open label, non-placebo-controlled phase II clinical trial (NCT04731103) in patients less than 16 years with any of five AGS genotypes. The effect of ABC or 3TC individually, or of combined ABC + 3TC + AZT, on IFN-stimulated gene (ISG) expression (primary outcome) and IFN-alpha protein (secondary outcome) in blood was assessed.
Objectives: International guidelines recommend IV crystalloid as the primary fluid for sepsis resuscitation, with 5% human albumin solution (HAS) as the second line. However, it is unclear which fluid has superior clinical effectiveness. We conducted a trial to assess the feasibility of delivering a randomized controlled trial comparing balanced crystalloid against 5% HAS as sole early resuscitation fluid in patients with sepsis presenting to hospital.
View Article and Find Full Text PDFIntroduction: The objective of this study was to determine whether computed tomography (CT) could be a useful tool for nonsolid lung nodule (NSN) treatment planning, surgery or stereotactic body radiation therapy (SBRT), by assessing the macroscopic and microscopic extension of these nodules.
Methods: The study prospectively included 23 patients undergoing anatomic resection at the Foch Hospital in 2020/2021 for NSN with a ground-glass component of more than 50%. Firstly, for each patient, both the macroscopic dimensions of the NSN were assessed on CT and during pathologic analysis.
Less-invasive thoracotomies may reduce early postoperative pain. The aims of this study were to identify pain trajectories from postoperative days 0-5 after posterolateral and axillary thoracotomies and to identify potential factors related to the worst trajectory. Patients undergoing a posterolateral (92 patients) or axillary (89 patients) thoracotomy between July 2014 and November 2015 were analyzed in this prospective monocentric cohort study.
View Article and Find Full Text PDFBackground: At the start of 2021, oncologists lacked the necessary scientific knowledge to adapt their clinical practices optimally when faced with cancer patients refusing or reluctant to be vaccinated against COVID-19, despite the marked vulnerability of these patients to severe, and even fatal forms of this new viral infectious disease. Oncologists at Foch Hospital were confronted with this phenomenon, which was observed worldwide, in both the general population and the population of cancer patients.
Methods: Between April and November 2021, the Ethics and Oncology Departments of Foch Hospital decided to investigate this subject, through an empirical and interdisciplinary study in bioethics.
Background: In the context of the SARS-CoV-2 pandemic, our interest was to evaluate the effect of COVID-19 during pregnancy on placenta and coagulation factors.
Methods: a prospective cohort study between January and July 2021 of 55 pregnant women stratified into: Group O, 16 patients with ongoing SARS-CoV-2 infection at delivery; Group R, 21 patients with a history of SARS-CoV-2 infection during pregnancy but who recovered prior to delivery; Group C, 18 control patients with no infection at any time. All women had nasopharyngeal SARS-CoV-2 RT-PCR tests performed within 72 h of delivery.
We aimed to demonstrate the antalgic effectiveness of Scenar (Self-Controlled Electro Neuro Adaptative Regulation) in patients experiencing low back and neck pain. Sixty patients were included and equally assigned by randomization to a Scenar-On group and to a Scenar-Off group (sham group). All patients received a 20 min application of Scenar on the area where they experienced pain.
View Article and Find Full Text PDFThe preoperative period may be an opportune period to optimize patients' physical condition with a multimodal preoperative program. The impact of a "prehabilitation" program on elderly patients is discussed. This mono-center observational cohort study included consecutively 139 patients planned for major abdominal and thoracic surgery, with 44 in the control group (age < 65) and 95 in the elderly group (age > 65).
View Article and Find Full Text PDFThe purpose of our work was to assess the independent and incremental value of AI-derived quantitative determination of lung lesions extent on initial CT scan for the prediction of clinical deterioration or death in patients hospitalized with COVID-19 pneumonia. 323 consecutive patients (mean age 65 ± 15 years, 192 men), with laboratory-confirmed COVID-19 and an abnormal chest CT scan, were admitted to the hospital between March and December 2020. The extent of consolidation and all lung opacities were quantified on an initial CT scan using a 3D automatic AI-based software.
View Article and Find Full Text PDFBackground And Objectives: Robotic surgery data need a setback on many years of practice with high-volume surgeons to evaluate its real value. Our main objective was to study the impact of a decade of robotic surgery on minimally-invasive hysterectomies for benign indications. Our secondary objectives were to evaluate our results for high-volume surgeons and complex cases.
View Article and Find Full Text PDFIntroduction And Hypothesis: To evaluate vaginal hysterectomy (VH) associated with vaginal native tissue repair (VNTR) using Campbell uterosacral ligament suspension (C-USLS) for the treatment of predominant uterine prolapse associated with cystocele.
Methods: We conducted a retrospective monocentric study including patients who underwent VH and C-USLS, without concomitant mesh, for primary urogenital prolapse between January 2011 and June 2018. We evaluated the anterior and apical prolapse recurrence rate, using a composite criterion (symptomatic, asymptomatic recurrence, POP-Q stage ≥ 2).
J Gynecol Obstet Hum Reprod
September 2021
Objective: The primary outcome was to determine risks factors for wound complications after cesarean section. Secondary outcome was the management of these complications.
Study Design: We performed a retrospective cohort study of consecutive cesarean deliveries performed at a secondary care facility between June 2017 and June 2019.