Methodological expectations for demonstration of health product effectiveness by observational studies.

The issue of assessing the effectiveness of health technologies (drugs, devices, etc.) through observational studies is becoming increasingly important as registration and market access agencies consider them in their evaluation process. In this context, observational studies must be able to provide real demonstrations of a level of reliability comparable to those produced by the conventional randomized controlled trial (RCT) approach.

Acceptability determinants of a proposal to reduce antiretroviral treatment to an oral two-drug regimen among patients living with HIV and physicians in France.

An oral two-drug regimen (O2DR) in the form of a once-a-day single tablet is now recommended for treatment switching and treatment initiation for HIV. In clinical care, the process of treatment change refers to adaptation issues, both individual and within the care relationship. The study aim is to present the determinants involved in the acceptability of switching to O2DR in the PROBI (Patient-Reported Outcomes BItherapy) qualitative study.

Workplace violence against female healthcare workers: a systematic review and meta-analysis.

Background: Workplace violence (WPV) is highly prevalent in the health sector and remains a major occupational issue causing significant harm, ranging from bodily and psychological harm to death. Female healthcare workers (HCWs) are at high risk of WPV.

Objectives: Identify risk factors of WPV among different professional categories of female HCWs.

Correction: Social and professional recognition are key determinants of quality of life at work among night-shift healthcare workers in Paris public hospitals (AP-HP ALADDIN COVID-19 survey).

[This corrects the article DOI: 10.1371/journal.pone.

Perceived health-related quality of life in people living with HIV co-infected with SARS-CoV-2 in France.

Purpose: We aimed to assess health-related quality of life (HRQL) and its correlates among people living with HIV/AIDS (PLWHA) co-infected with SARS-CoV-2 in France.

Methods: This cross-sectional was study conducted among PLWHA co-infected with SARS-CoV-2. HRQL was measured using the four dimensions of the PROQOL-HIV scale.

Development of a risk prediction score for screening for HBV, HCV and HIV among migrants in France: results from a multicentre observational study (STRADA study).

Objectives: Migrants from high HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) endemicity regions have a great burden of these infections and related diseases in the host countries. This study aimed to assess the predictive capacity of the Test Rapide d'Orientation Diagnostique (TROD) Screen questionnaire for HIV, HBV and HCV infections among migrants arriving in France.

Design: An observational and multicentre study was conducted among migrants.

Predictors of health-related quality of life in a large cohort of adult patients living with sickle cell disease in France: the DREPAtient study.

Background: Sickle cell disease (SCD) is an inherited autosomal recessive disorder exhibiting a range of symptoms and acute and/or chronic complications that affect the quality of life. This study aimed to assess health-related quality of life (HRQoL) and to identify the associated factors in adult patients with SCD in France.

Methods: DREPAtient is a cross-sectional, multicenter study conducted from June 2020 to April 2021 in France and in certain French overseas territories where SCD is highly prevalent.

Homeopathy as Praxis: Integration of Homeopathy as Supportive Care into Daily Life in Early Breast Cancer Patients.

Introduction: Homeopathy is one of most widely used non-conventional supportive care methods used by women with breast cancer. This article aims to describe the routines and practices related to homeopathy as supportive care used by women with non-metastatic breast cancer in France.

Methods: This qualitative study used Grounded Theory.

Factors associated with sexual quality of life among men living with HIV.

Introduction: This study aims to assess the prevalence of sexual difficulties and identify factors associated with the Sexual Quality of Life (SQoL) among people living with HIV (PLWHA).

Methods: The study included 107 heterosexual men and 474 men who have sex with men (MSM) from five countries. Participants self-reported variables related to physical and mental health, as well as HIV-related parameters.

Opportunities to improve the adoption of health-related quality of life evidence as part of the French Health Technology Assessment process.

Objectives: Patient's health-related quality of life (HRQoL) is an important outcome measure that is considered by many payers and health technology assessment (HTA) bodies in the evaluation of treatments. We aimed to identify opportunities for HRQoL to be further incorporated into the assessment of the French HTA by comparing three health systems. We put forward recommendations that could bring further innovations to French patients.

Exploring the limitations of language interpretation: A qualitative study on clinicians' experiences at French Office of Immigration and Integration.

The concordance of communication between patients and health professionals is essential to promoting positive health outcomes. However, concordance may be broken where language barriers exist therefore creating a need to use interpretation services. This is the case when rapid diagnostic testing (RDT) of HIV, HBV, and HCV is offered to migrants.

Data Monitoring Committees and clinical trials: From scientific justification to organisation.

Clinical trials often last several months or even several years. As the trial progresses, it can be tempting to find out whether the data obtained already answers the question posed at the start of the trial in order to stop inclusions or monitoring earlier. However, knowing and taking into account interim results can sometimes compromise the integrity of the results, which is counterproductive.

Fostering Patient-Clinician Communication to Promote Rapid HIV, Hepatitis B Virus, and Hepatitis C Virus Diagnostic Testing: Conceptual Development of a Multilingual App.

Background: Migrants are disproportionately affected by HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV). Clinicians, at times, fail to offer rapid diagnostic testing (RDT) for these viruses when a language barrier exists in the patient-clinician relationship, therefore creating missed testing opportunities. Although their effectiveness has been demonstrated elsewhere, conventional, in-person interpreters are costly and underused in practice.

Cross-perspectives on care pathways for painful osteoarthritis: A qualitative analysis in patients and healthcare professionals.

Purpose: To analyse and compare patients' and healthcare professionals' (HPs) perspectives concerning patient care pathways for painful osteoarthritis (OA).

Patients And Methods: We performed a qualitative study of two focus groups corresponding to eight patients with painful OA and eight HPs involved in OA management.

Results: Six key themes emerged from the interviews: (1) representations of OA, (2) OA pain, (3) quality of life, (4) care pathways, (5) actors involved in the care pathway, and (6) treatments.

Treatment burden, adherence, and quality of life in children with daily GH treatment in France.

Objective: The objective of this study was to describe in a real-life setting the treatment burden and adherence and quality of life (QOL) of children treated with daily injections of growth hormone and their relationship with treatment duration.

Design: This non-interventional, multicenter, cross-sectional French study involved children aged 3-17 years treated with daily growth hormone injections.

Methods: Based on a recent validated dyad questionnaire, the mean overall life interference total score (100 = most interference) was described, with treatment adherence and QOL, using the Quality of Life of Short Stature Youth questionnaire (100 = best).

Negative representations of night-shift work and mental health of public hospital healthcare workers in the COVID-19 era (Aladdin survey).

Background: Many risk factors impact the health of hospital night workers, which can lead to physical and mental health disorders. During the recent period, night hospital workers have been particularly stressed. This study therefore aims to: (i) To document the prevalence of depression, anxiety, sleep disorders, and symptoms suggestive of post-traumatic stress disorder in night shift workers (NSHW) working in Parisian public hospitals after France's first COVID-19 wave ended; (ii) To estimate the effect of negative representations and perceptions of night shift work on these mental health outcomes.

Evaluating Clinician Expectations of mHealth Solutions to Increase Rapid-Screening for HIV and Hepatitis in Migrant Populations in France: Qualitative Study.

Background: Migrants underuse screening opportunities for HIV, hepatitis B, and hepatitis C despite elevated risk factors for contracting these infections. Language barriers are an often given as reasons for limiting access to services. Translation and communication apps increase communication and overall patient satisfaction in the patient-provider relationship.

Positive relations between sexual quality of life and satisfaction with healthcare in women living with HIV and/or HCV: Results from a multicountry study.

Introduction: The sexual quality of life is a neglected concern in women living with HIV (WHIV) or with HCV (WHCV), which can further be affected by their experience with stigma, social instability, fear of transmission and reduced access to treatment. The objective of this study was to identify sociodemographic, psychosocial, and behavioural factors associated with sexual quality of life (SQoL) in this study group.

Methods: Between December 2017 and December 2018, PROQoL-Sex Life questionnaire was administered to 404 WHIV and WHCV in five countries.

Platform trials.

For the past few years, platform trials have experienced a significant increase, recently amplified by the COVID-19 pandemic. The implementation of a platform trial is particularly useful in certain pathologies, particularly when there is a significant number of drug candidates to be assessed, a rapid evolution of the standard of care or in situations of urgent need for evaluation, during which the pooling of protocols and infrastructure optimizes the number of patients to be enrolled, the costs, and the deadlines for carrying out the investigation. However, the specificity of platform trials raises methodological, ethical, and regulatory issues, which have been the subject of the round table and which are presented in this article.

Patient-reported outcomes labeling for oncology drugs: Multidisciplinary perspectives on current status and future directions.

Regulatory agencies encourage the incorporation of the patient voices throughout clinical drug development. Patient-Reported Outcomes (PROs) offer one way of doing this and their use has markedly increased in many therapeutic areas, particularly oncology, in recent years. However, few oncology drug labels include PRO data and those which do, offer little consistency.

Risk Prediction Score for Screening Asymptomatic Sexually Transmitted Infections in HIV-positive French Men Who Have Sex with Men (ANRS 9520 DRIVER).

Objectives: Asymptomatic sexually transmitted infections (STI) are frequent among men who have sex with men (MSM). Identifying asymptomatic STIs is a crucial issue, not only for secondary but also for primary prevention, as early treatment can reduce transmission risk. We aimed to develop a self-reported predictive score for early identification of asymptomatic STIs.