How can the reform of the activity-based payment system (T2A) help in financing innovative health products?

In France, the short-stay activities of public and private sector healthcare facilities have been financed since 2004 by activity-based pricing (T2A). The principle is to allow for payment determined primarily by the nature and volume of activities. T2A has enabled a major transformation compared to the old financing system, chiefly for public sector facilities that used to operate under a general allocation, and convergence between payment methods in the public and private sectors.

Evaluation of digital medical devices: How to take into account the specificities of these solutions?

The beginning of the 21st century has seen an increasing number of digital medical devices (DMDs) arrive on the European market, bringing major benefits and changes for society. DMDs are unique in that they bring intelligence to the organisation of care, and generate and collect a wealth of real-life data with ultra-fast life cycles. They have specific requirements, particularly in terms of data security and interoperability.

[Innovation funding schemes and the structuring of health economic evaluation in France].

Diffusion and reimbursement of healthcare strategies, drugs or medical devices are based on decisions made by public authorities and health authorities. In a situation of restricted resources and strict budget restrictions, decisions on innovative and costly health products must take into account not only efficacy and safety data, but also efficiency data. In France, generate health economics data to inform on efficiency can be obtain by different processes, resulting in an opportunity to develop, structure and finance health economic evaluation.

Cost effectiveness and long-term outcomes of dexamethasone administration in major non-cardiac surgery.

Study Objectives: Postoperative administration of dexamethasone has been proposed to reduce morbidity and mortality in patients undergoing major non-cardiac surgery. In this ancillary study of the PACMAN trial, we aimed to evaluate the cost effectiveness of dexamethasone in patients undergoing major non-cardiac surgery.

Methods: Patients included in the multicentric randomized double-blind, placebo-controlled PACMAN trial were followed up for 12 months after their surgical procedure.

[Tocolysis during External Cephalic Version (ECV): A retrospective before/after study in a type III maternity hospital].

Objective: On January 2020, the French College of Gynecologists and Obstetricians (CNGOF) issued new Clinical Practice Guidelines (CPG) "Breech Presentation". Since then, it is recommended to use a tocolytic agent to improve the success rate of External Cephalic Version (ECV). The aim of this study, one year after these CPG, is to compare ECV without (before CPG) and with (after CPG) tocolysis in a type III maternity hospital.

Feasibility of Combining Transcranial Direct Current Stimulation and Active Fully Embodied Virtual Reality for Visual Height Intolerance: A Double-Blind Randomized Controlled Study.

Background: Transcranial Direct Current Stimulation (tDCS) and Virtual Reality Exposure Therapy (VRET) are individually increasingly used in psychiatric research.

Objective/hypothesis: Our study aimed to investigate the feasibility of combining tDCS and wireless 360° full immersive active and embodied VRET to reduce height-induced anxiety.

Methods: We carried out a pilot randomized, double-blind, controlled study associating VRET (two 20 min sessions with a 48 h interval, during which, participants had to cross a plank at rising heights in a building in construction) with online tDCS (targeting the ventromedial prefrontal cortex) in 28 participants.

Outcomes of Same-Day Discharge with Manual Compression and 5F Sheath Compatible Devices for Lower Extremity Arterial Endovascular Treatment.

Background: For same-day discharge lower extremity arterial disease (LEAD) endovascular procedures, femoral manual compression could be an alternative to arterial closure devices. The aim of this study was to assess the security and efficacy of same-day discharge after manual compression in patients treated for LEAD endovascular revascularization with 5F sheath.

Methods: FREEDOM OP was a national multicenter, prospective, single arm study.

Management of external cephalic version in France: A national practice survey.

Introduction: The breech presentation represents 4,7% of deliveries at term. There is a method of external cephalic version (ECV) performed from 36 weeks of gestation. French guidelines for the clinical practice of ECV were published in 2020.

A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization.

Purposes: The primary objective of this study (STEP trial) was to compare the efficacy of the polymer-based FemoSeal® vascular closure device (VCD) and the suture-based ProGlide® VCD in achieving hemostasis at the femoral access site after lower-limb arterial endovascular revascularization.

Materials And Methods: STEP was a multicenter randomized clinical trial including patients undergoing lower-limb arterial endovascular revascularization. The primary endpoint was technical success 5 h after the VCD intervention, defined as achievement of hemostasis without the need for a follow-up intervention at the access site and without a 2-g/dL drop in hemoglobin.

Editor's Choice - A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial.

Objective: The AMBUVASC trial evaluated the cost effectiveness of outpatient vs. inpatient hospitalisation for endovascular repair of lower extremity arterial disease (LEAD).

Methods: AMBUVASC was a national multicentre, prospective, randomised controlled trial conducted in nine public and two private French centres.

Methods of detection and prevention of preterm labour and the PAMG-1 detection test: a review.

Objectives: Preterm labour is the leading cause of hospitalization during pregnancy. In France, it results in more than 60,000 births before 37 weeks of gestation every year. Recent studies suggest that detection of placental α-microglobulin-1 (PAMG-1) in vaginal secretions among women presenting symptoms of preterm labour with intact membranes has good predictive value for the onset of spontaneous preterm delivery within 7 days.

Review: Why screen for severe combined immunodeficiency disease?

Newborn screening for severe combined immunodeficiency (SCID) is now routinely performed in many countries across Europe and around the world. The number of T-cell receptor excision circles (TRECs) reflects T cell levels. TREC quantification is possible using dried blood spot (DBS) samples already collected from newborns to screen for other conditions.

Cost of red blood cell transfusion; evaluation in a French academic hospital.

Objectives: The economic impact of Patient blood management (PBM) must be assessed beyond the acquisition cost of blood products alone. The estimate of indirect costs may vary depending on the organization and the elements taken into account. The transposition of data from the literature into a specific local context is therefore delicate.

The value of a vaginal sample for detecting PAMG-1 (Partosure®) in women with a threatened preterm delivery (the MAPOSURE Study): protocol for a multicenter prospective study.

Background: Threatened preterm delivery (TPD) is the leading cause of inpatient admissions during pregnancy. The ability to predict the risk of imminent preterm delivery is thus a major priority in obstetrics. The aim of our study is to assess the diagnostic performance of the test to detect the placental alpha microglobulin 1 (PAMG-1) for the prediction of delivery within 7 days in women with TPD.

FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial.

Background: Acne vulgaris has increased in women over the past 10 years; it currently affects 20-30% of women. The physiopathology of adult female acne is distinguished from that of teenagers essentially by two factors: hormonal and inflammatory. On a therapeutic plan, the four types of systemic treatment approved for female acne include cyclines (leading to bacterial resistance); zinc salts (less effective than cyclines); and antiandrogens (risks of phlebitis).