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. Factors associated with each dimension were identified using linear regression. RESULTS: mean (SD) scores for HRQL dimensions: 76.7 (± 21.1) for Physical Health and Symptoms (PHS), 79.2 (± 23.6) for Social Relationships (SR), 67.3 (± 27.4) for Mental and Cognitive (MC), and 83.9 (± 16.5) for Treatment Impact (TI). Employment status and COVID-19 knowledge were associated with higher PHS score, while blood transfusion-acquired HIV, CDC HIV, hospital discharge instructions, and self-reported symptoms were associated with lower PHS score. Couple status was associated with higher SR score, whereas, hospital discharge instructions, CDC HIV stage C, drug injection-acquired HIV, self-reported symptoms, and COVID-19 vulnerability perception were associated with lower SR score. Employment status and French birth were associated with higher MC score, while female sex, detectable HIV viral load, hospital discharge instructions, COVID-19 vulnerability perception, smoking, and self-reported symptoms were associated with lower MC score. French birth and homosexual/bisexual relationships-acquired HIV were associated with higher TI score, while detectable HIV viral load, psychiatric disorders, and self-reported symptoms were associated with lower TI score CONCLUSION: Among PLWHA co-infected with SARS-CoV-2, the scores of HRQL were impaired, particularly in the MC dimension. Findings underscore the multidimensional nature of HRQL, with notable variations across different dimensions. Understanding these correlates is crucial for tailored interventions aimed at improving the well-being of this population.

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. METHODS: An observational cross-sectional online survey of NSHW (June to September 2020) in 39 public hospitals in Paris, France. Standard scales were used to measure mental health outcomes. Weighted multinomial logistic regression models supported the identification of predictors of depression (score > 10 on the Hospital Anxiety and Depression Scale, HADS, for depression), anxiety (score > 10 on the HADS for anxiety), severe insomnia (score > 21 on the Insomnia Severity Index, ISI) and symptoms suggestive of post-traumatic stress disorder (score > 36 on the Impact of Event Scale-Revised, IES-R). RESULTS: The weighted prevalence rates [95% confidence interval] of depression, anxiety, severe insomnia, and symptoms of post-traumatic stress disorder were, respectively, 18.9% [16.5-21.2], 7.6% [6.0-9.1], 8.6% [6.9-10.2] and 11.7% [9.7-13.6]. After multiple adjustment, organizational changes in NSHW professional lives due to the COVID-19 pandemic (such as moving to another hospital department and modified schedules) and NSHW-perceived negative representations of night work were significantly associated with all studied mental health outcomes. CONCLUSION: Our findings confirm the importance of monitoring mental health and sleep quality among NSHW in Parisian public hospitals, even more during health crises. Multilevel interventions aiming at reducing negative representations and improving work organization are urgently needed to improve overall health of this frontline healthcare providers group.

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. METHODS: We reviewed methodologies by the French, German and British HTA, and conducted a systematic review of all French (n = 312) and German (n = 175) HTA appraisals from 01 January 2019 to 31 December 2021. We also setup an advisory board of 11 ex-HTA leaders, payers, methodologists, healthcare providers and patient advocates, from France, Britain and Germany, to discuss opportunities to improve acceptance and adoption of HRQoL evidence in France. RESULTS: Our systematic review of HTA appraisals showed a higher HRQoL data rejection rate in France: in > 75% of cases the HRQoL evidence submitted was not accepted for the assessment (usually for methodological reasons, for example, data being considered exploratory; 16-75% of the appraisals mentioned HRQoL evidence, varying by therapeutic area). Overall, we found the French HTA to be more restrictive in its approach than IQWiG. CONCLUSIONS: Based on these findings we articulate collaborative proposals for industry and the HAS to improve acceptance of HRQoL evidence and create a positive feedback loop between HAS and industry along four dimensions (1) patient perception, (2) testing hierarchy, (3) trial design and (4) data collection.

Is IQWiG's 15% Threshold Universally Applicable in Assessing the Clinical Relevance of Patient-Reported Outcomes Changes? An ISPOR Special Interest Group Report.

This article discusses a recent methodological change to assess the additional benefit of drug intervention by the German Federal Joint Committee (Gemeinsamer Bundesausschuss), a key stakeholder in EUnetHTA21 (European Network for Health Technology Assessment joint consortium for future EU HTA regulation), methodological workstream. The German Federal Joint Committee (Gemeinsamer Bundesausschuss) set a universal individual response threshold at ≥ 15% of the scale range of the measurement instrument, for all patient-reported outcomes, to achieve an additional benefit rating for a given pharmaceutical intervention. This approach is originally based on a corresponding recommendation from the Institute for Quality and Efficiency in Health Care. The merits of this approach are reviewed from various perspectives, including the evidence basis, statistical and psychometric considerations, and regulatory perspectives by the ISPOR Clinical Outcomes Assessment Special Interest Group's multistakeholder group of authors (academia, contract research organizations, and industry). Particular focus is placed on the patient perspective within the Institute for Quality and Efficiency in Health Care approach. The article development incorporated feedback from ISPOR members during well-attended ISPOR US and European conference presentations and 2 formal rounds of written review. The authors concluded that the ≥ 15% response threshold is incongruent with previously defined and scientifically established thresholds and is not well-suited for universal implementation. Further scientific evidence and discussion among all stakeholders are needed, especially should this universal rule be considered in the context of future joint clinical assessments of health technologies in the European Union scheduled from 2025 onward.

A poor diet quality is associated with more gas-related symptoms and a decreased quality of life in French adults.

This study evaluated the association between dietary patterns, Gas-Related Symptoms (GRS) and their impact on quality of life (QoL) in a representative sample (n=936) of the French adult population. During the 2018-2019 "Comportements et Consommations Alimentaires en France" (CCAF) survey (Behaviors and Food Consumption in France), online evaluation of GRS in adult participants was performed using the validated Intestinal Gas Questionnaire (IGQ), which captures the perception of GRS and their impact on QoL via 6 symptom dimensions scores (range 0-100; 100=worse) and a global score (mean of the sum of the 6 symptom dimensions scores). Socio-demographics, lifestyle parameters and dietary habits (7-day e-food diary) were also collected online. Quality of diet was determined using the NRF9.3 score (range 0-900; 900=best). Univariate and multivariate linear regression models were applied to identify factors associated with IGQ global score. K-means was used to identify clusters of subjects based on their dietary records. Data from 936 adults who completed both the IGQ and the food diary showed a mean (SD) IGQ global score of 11.9 (11.2). Younger age and female gender were associated with a higher IGQ global score. Only 7% of subjects reported no symptom at all and nearly 30% of study participants reported a high impact of GRS on their QoL. Two dietary clusters were identified: cluster1, characterized by a higher consumption of fruits and vegetables, lower sugars intake and higher NRF9.3 score and cluster 2, characterized by higher intake of sugars, lower intake in dietary fibers and lower NRF9.3 score. The IGQ global score was lower in cluster1 and higher in cluster2 vs. the total sample average (p<0.001). Prevalence of GRS in the French adult population is high and is associated with impaired QoL and dietary patterns. A change in food habits towards healthier patterns could help reducing the burden of GRS.

A call to action to harmonize patient-reported outcomes evidence requirements across key European HTA bodies in oncology.

Patient-reported outcome (PRO) data are increasingly being included in Health Technology Assessment (HTA) submissions for oncology drugs. This study aims to provide differences in PRO evidence requirements in oncology across key HTA bodies and calls for its harmonization. Method guidance provided by HTA bodies in Germany, France and the UK, and analysis of HTA reports of 20 oncology case studies were evaluated in this review. Differences exist between HTA bodies regarding guidance on how PRO data should be collected, reported and analyzed as well as how the data are reviewed and considered in oncology HTAs. HTA bodies can play a key role to harmonize PRO method guidance in collaboration with regulators and sponsors.

Patient-reported outcomes (PRO) are information provided directly by the person who is experiencing a disease or undergoing a treatment, without additional interpretation by a clinician or caregiver. Along with other outcome measures, PROs may be included in the body of evidence used by health technology assessment bodies in their review. In this article, the authors summarize the guidance documents published by key health technology assessment agencies and reviewed 20 past cancer drug case studies to understand how different agencies use PROs when deciding on recommendations for new cancer treatments.

Perceived stigma, substance use and self-medication in night-shift healthcare workers: a qualitative study.

BACKGROUND: Many risk factors related to altered circadian rhythms impact the health of night-shift hospital workers (NSHW), resulting in mental and somatic disorders. Easy access to psychoactive substances (PS) may facilitate addictive behaviors in NSHW. They are also exposed to a stressful work environment, which may further affect sleep quality. This study aimed to explore the link between sleep deprivation, work-related psychosocial stress and psychoactive substance use as a self-medication response in NSHW. METHODS: Qualitative study to verify the plausibility of the self-medication theory applied to addictive behaviors. Semi-structured interviews (N = 18 NSHW) and thematic analysis, following consolidated criteria for reporting qualitative research recommendations. RESULTS: Stigma against NSHW was a primary element of a stressful work environment. The stressful and stigmatizing environment, together with night-shift work, further affected NSHW sleep and their mental and physical health. The use of PS appeared to be for self-medication, encouraged by social and professional environments, source(s) of stress, discrimination, and isolation. The work environment, through aggravated sleep disorders, led NSHW to use non-prescribed sleeping pills. Alcohol after work and smoking were used as a social break but also as a means to reduce stress. CONCLUSION: Anti-stigma interventions in the healthcare setting and screening of mental/somatic disorders in NSHW can help reduce harmful self-medication behaviors and improve hospital care in the COVID-19 era.

Electronic Tools to Bridge the Language Gap in Health Care for People Who Have Migrated: Systematic Review.

BACKGROUND: People who have migrated or with a language barrier may face significant hurdles in accessing health care. Some apps have been specifically developed to facilitate the dialogue between health care professionals and people who have migrated who have low-level language proficiency or to promote health among people who have migrated. OBJECTIVE: We conducted a systematic review to investigate development, acceptability, and effectiveness of these types of apps. METHODS: We conducted a search of PubMed, Scopus, and Embase databases. We included all study designs (qualitative, quantitative, mixed) reporting development, evaluation of efficacy, or acceptability of apps facilitating dialogue with a health professional or promoting health for people who have migrated, minorities, or tourists with a language barrier, using any outcome. Two researchers selected the studies independently. We collected general information about the app, information about health literacy and cultural adaptation, information about the development of the app, evidence on acceptability or efficacy, and information on app use. Data were collected by 2 researchers independently and results were reviewed to verify agreement and reported according to PRISMA (Preferred Reporting Items for Systematic Review and Meta-analysis). RESULTS: Positive results for translation apps included better communication, but with possible limitations, and reduced consultation time. Positive results for health promotion apps included improved quality of life and better management of chronic illnesses. CONCLUSIONS: Overall, the apps had good levels of acceptability, though only half had their efficacy evaluated. In those evaluations, the endpoints were mostly related to reported behavior change and knowledge improvement, which is common for evaluations of health promotion programs. In the future, as more health apps are created, it is essential that apps that claim to have a public health objective undergo a rigorous evaluation of their acceptability, efficacy, and actual use. Indicators of outcomes beyond changes in behavior and knowledge should be reported; change in health status or access to care should also be reported. This systematic review has helped us note the characteristics associated with improved acceptability and efficacy, which can be helpful for the development of future apps.

Patients' high acceptability of a future therapeutic HIV vaccine in France: a French paradox?

BACKGROUND: France is the European country with the lowest level of confidence in vaccines. Measurement of patients' acceptability towards a future therapeutic HIV vaccine is critically important. Thus, the aim of this study was to evaluate patients' acceptability of a future therapeutic HIV vaccine in a representative cohort of French patients living with HIV-AIDS (PLWHs). METHODS: This multicentre study used quantitative and qualitative methods to assess PLWHs' opinions and their potential acceptance of a future therapeutic HIV vaccine. Cross-sectional study on 220 HIV-1 infected outpatients, aged 18-75 years. RESULTS: The participants' characteristics were similar to those of the overall French PLWH population. Responses from the questionnaires showed high indices of acceptance: the mean score for acceptability on the Visual Analog Scale VAS was 8.4 of 10, and 92% of patients agreed to be vaccinated if a therapeutic vaccine became available. Acceptability depended on the expected characteristics of the vaccine, notably the duration of its effectiveness: 44% of participants expected it to be effective for life. This acceptance was not associated with socio-demographic, clinical (mode of contamination, duration of disease), quality of life, or illness-perception parameters. Acceptability was also strongly correlated with confidence in the treating physician. CONCLUSION: The PLWHs within our cohort had high indices of acceptance to a future therapeutic HIV vaccine. TRIAL REGISTRATION: This study was retroactively registered on ClinicalTrials.gov with ID: NCT02077101 in February 21, 2014.

Development and Evaluation of a New Serious Game for Continuing Medical Education of General Practitioners (Hygie): Double-Blinded Randomized Controlled Trial.

BACKGROUND: Continuing medical education is important but time-consuming for general practitioners (GPs). Current learning approaches are limited and lack the ability to engage some practitioners. Serious games are new learning approaches that use video games as engaging teaching material. They have significant advantages in terms of efficiency and dissemination. OBJECTIVE: The aim of this study was to create a serious game and to evaluate it in terms of effectiveness and satisfaction, comparing it with a traditional method of continuing education-article reading. METHODS: We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent evidence-based medicine journals (reviews from Prescrire and Minerva). We created 51 clinical cases. We then conducted a double-blinded randomized trial comparing the learning provided by a week of access to the game versus source articles. Participants were GPs involved as resident supervisors in 14 French university departments of family practice, recruited by email. Primary outcomes were (1) mean final knowledge score completed 3 to 5 weeks after the end of the intervention and (2) mean difference between knowledge pretest (before intervention) and posttest (3 to 5 weeks after intervention) scores, both scaled on 10 points. Secondary outcomes were transfer of knowledge learned to practice, satisfaction, and time spent playing. RESULTS: A total of 269 GPs agreed to participate in the study. Characteristics of participants were similar between learning groups. There was no difference between groups on the mean score of the final knowledge test, with scores of 4.9 (95% CI 4.6-5.2) in the Hygie group and 4.6 (95% CI 4.2-4.9) in the reading group (P=.21). There was a mean difference score between knowledge pre- and posttests, with significantly superior performance for Hygie (mean gain of 1.6 in the Hygie group and 0.9 in the reading group; P=.02), demonstrating a more efficient and persistent learning with Hygie. The rate of participants that reported to have used the knowledge they learned through the teaching material was significantly superior in the Hygie group: 77% (47/61) in the Hygie group and 53% (25/47) in the reading group; odds ratio 2.9, 95% CI 1.2-7.4. Moreover, 87% of the opinions were favorable, indicating that Hygie is of interest for updating medical knowledge. Qualitative data showed that learners enjoyed Hygie especially for its playful, interactive, and stimulating aspects. CONCLUSIONS: We conclude that Hygie can diversify the offering for continuing education for GPs in an effective, pleasant, and evidence-based way. TRIAL REGISTRATION: ClinicalTrials.gov NCT03486275; https://clinicaltrials.gov/ct2/show/NCT03486275.

Barriers to publishing in biomedical journals perceived by a sample of French researchers: results of the DIAzePAM study.

BACKGROUND: As publishing is essential but competitive for researchers, difficulties in writing and submitting medical articles to biomedical journals are disabling. The DIAzePAM (Difficultés des Auteurs à la Publication d'Articles Médicaux) survey aimed to assess the difficulties experienced by researchers in the AP-HP (Assistance Publique - Hôpitaux de Paris, i.e., Paris Hospitals Board, France), the largest public health institution in Europe, when preparing articles for biomedical journals. The survey also aimed to assess researchers' satisfaction and perceived needs. METHODS: A 39-item electronic questionnaire based on qualitative interviews was addressed by e-mail to all researchers registered in the AP-HP SIGAPS (Système d'Interrogation, de Gestion et d'Analyse des Publications Scientifiques) bibliometric database. RESULTS: Between 28 May and 15 June 2015, 7766 researchers should have received and read the e-mail, and 1191 anonymously completed the questionnaire (<45 years of age: 63%; women: 55%; physician: 81%; with PhD or Habilitation à Diriger des recherches--accreditation to direct research--: 45%). 94% of respondents had published at least one article in the previous 2 years. 76% of respondents felt they were not publishing enough, mainly because of lack of time to write (79%) or submit (27%), limited skills in English (40%) or in writing (32%), and difficulty in starting writing (35%). 87% of respondents would accept technical support, especially in English reediting (79%), critical reediting (63%), formatting (52%), and/or writing (41%), to save time (92%) and increase high-impact-factor journal submission and acceptance (75%). 79% of respondents would appreciate funding support for their future publications, for English reediting (56%), medical writing (21%), or publication (38%) fees. They considered that this funding support could be covered by AP-HP (73%) and/or by the added financial value obtained by their department from previous publications (56%). CONCLUSIONS: The DIAzePAM survey highlights difficulties experienced by researchers preparing articles for biomedical journals, and details room for improvement.

The International development of PROQOL-HCV: An instrument to assess the health-related quality of life of patients treated for Hepatitis C virus.

BACKGROUND: Hepatitis C virus (HCV) compromises Health-related Quality of Life (HRQL) with detriments to Physical, Mental and Social health domains. Treatment with interferon and ribavirin is associated with side effects which further impair HRQL. New treatments appear potent, effective and tolerable. However, Patient Reported Outcomes instruments that capture the impact on HRQL for people with hepatitis C are largely non-specific and will be needed in the new treatment era. Therefore, we developed a conceptually valid multidimensional model of HCV-specific quality of life and pilot survey instrument, the Patient Reported Outcome Quality of Life survey for HCV (PROQOL-HCV). METHODS: HCV patients from France (n = 30), Brazil (n = 20) and Australia (n = 20) were interviewed to investigate HCV-HRQL issues raised in the scientific literature and by treatment specialists. Interviews were recorded, transcribed and translated into English and French. RESULTS: Fifteen content dimensions were derived from the qualitative analysis, refined and fitted to four domains: (1) Physical Health included: fatigue, pain, sleep, sexual impairment and physical activity; (2) Mental Health: psychological distress, psychosocial impact, and cognition; (3) Social Health: support, stigma, social activity, substance use; (4) TREATMENT: management, side effects, and fear of treatment failure. The impact of some dimensions extended beyond their primary domain including: physical activity, cognition, sleep, sexual impairment, and the three treatment dimensions. A bank of 300 items was constructed to reflect patient reports and, following expert review, reduced to a 72-item pilot questionnaire. CONCLUSION: We present a conceptually valid multidimensional model of HCV-specific quality of life and the pilot survey instrument, PROQOL-HCV. The model is widely inclusive of the experience of hepatitis C and the first to include the treatment dimension.

Psychometric assessment of health-related quality of life and symptom experience in HIV patients treated with antiretroviral therapy.

PURPOSE: Symptoms which are found to cluster consistently can have synergistic effects on patient outcomes and therefore may serve to predict morbidity or disentangle disease progression from comorbid conditions. Self-report HIV-specific symptom and HRQL measures were jointly analyzed in HIV-positive patients under different antiretroviral treatment regimens. METHODS: The responses of N = 365 patients from four countries to the 9-item Physical Health and Symptom dimension of the PROOQL-HIV questionnaire and an HIV Symptom checklist were analyzed. Item response modeling and multidimensional scaling were used to derive HRQL scores free of any differential item functioning related to gender and target language and to summarize symptom co-expression in patients under protease inhibitor treatment(PI, N = 164, 45%) versus other medication (Non-PI). RESULTS: Women reported poorer HRQL (p = 0:037), and HRQL did not differ between the target languages of French, English, and Thai. Fatigue, muscular pain, or difficulties falling asleep was the most frequently reported symptoms [35%). PI versus Non-PI patients exhibited different pattern of symptoms with lipodystrophy-related and gastrointestinal symptoms forming well-separated clusters in the PI group. A higher number of symptoms were associated with lower HRQL (p < 0:001), and patients taking PIs reported lower HRQL (p = 0:003). Patients in both groups who reported fatigue, sexual dysfunction, or several lipodystrophy-related symptoms had poorer quality of life.

The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop.

In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jardé Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency.

ARIZONA study: is the risk of post-herpetic neuralgia and its burden increased in the most elderly patients?

BACKGROUND: In a context of change in the demographic profile of the older population, to identify an age threshold for increased risk and burden of herpes zoster (HZ) in 70+ patients. METHODS: Post hoc analysis of the 12-month French nationwide prospective observational ARIZONA cohort study. HZ was assessed by means of the following validated questionnaires: Neuropathic Pain Symptom Inventory (NPSI), Zoster Brief Pain Inventory (ZBPI), Short-Form health survey (SF-12), and Hospital Anxiety and Depression Scale (HADS). RESULTS: 644 general practitioners included 1,358 volunteer patients with acute HZ in the ARIZONA study; 609 patients (45%) were 70+. In 70+ patients, age did not increase rash severity or HZ-related pain intensity at diagnosis, but increased by 64% the frequency of ophthalmic zoster (from 5.5% in 70-74 years age-group to 9.0% in 85+ patients, p = NS). Age was significantly associated with low physical health as assessed by the SF-12 Physical Component Summary (SF-12 PCS) score and bad mood as assessed by the HADS depression score (p < 0.001). Within the year following HZ, post-herpetic neuralgia (PHN) was systematically but not significantly more frequent in 85+ patients than in the 70-74, 75-79, or 80-84 years age-groups (19.0% vs. 13.3%/15.3%/11.6% at month 3; 15.1% vs. 7.3%/11.0%/12.2% at month 6; 15.2% vs. 6.0%/8.0%/6.0% at month12, respectively). SF-12 PCS and HADS depression scores improved from day 0 to month 12 in all patients (p < 0.001). 85+ patients were more impaired than younger patients (p < 0.001), but without clear difference according to PHN. CONCLUSIONS: This study did not show in 70+ patients a clear and significant age threshold at which disease burden increased, although for some domains the impact seemed higher among the oldest patients; the cut-off of 70 years remains thus relevant for clinical and epidemiological studies. However, at individual level, assessment of the burden of HZ and HZ-related pain appears necessary to improve management and prevent functional decline in the most vulnerable 70+ patients.

Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients.

BACKGROUND: Facial lipoatrophy is a frequently reported condition associated with use of antiretroviral (ARV) drugs. Poly-L-lactic acid (PLLA) acid has been used to correct facial lipoatrophy in people with HIV since 2004 both in Europe and the United States. The objective of this study was to establish, in real life conditions and in a large sample, the safety of PLLA (New Fill®, Valeant US, Sinclair Pharma Paris, France) to correct facial lipoatrophy among HIV-positive patients. METHODS: A longitudinal study was conducted between 2005 and 2008 in France. Data from 4,112 treatment courses (n = 4,112 patients) and 15,665 injections sessions (1 to 5 injection sessions per treatment course) were gathered by 200 physicians trained in the use of PLLA. RESULTS: The average age of patients (88.3% males) treated for lipoatrophy was 47.1 ± 8.1 years (Mean ± SD); 91.2% of patients had been receiving ARV treatment for 10.9 (±4.2) years; CD4 T-cell count was 535 ± 266 cells/mm3. The duration of facial lipoatrophy was 5 ± 2.8 years and the severity was such that 47.3% of patients required five injection sessions of PLLA and 81.9% of the sessions required two vials of the preparation. The final visit, scheduled two months after the last injection session, was attended by 66.0% of patients (n = 2,713). 48 treatment courses (2.8%) were discontinued due to adverse events (AEs). The overall incidence of AEs per course was 18.8%. Immediate AEs, bleeding (3.4%), bruising (2.3%), pain (2.0%), redness at injection site (1.6%), and swelling of the face (0.7%), occurred in 15.4% of courses and 7.0% of sessions (usually during the first session). Non-immediate AEs, mainly nodules (5.7%), inflammation (0.7%), granuloma (0.3%), discolouration (0.2%), and skin hypertrophy (0.1%), occurred in 6.7% of courses. Non-immediate AEs occurred within a time ranging from 21 days (inflammation) to 101 days (granuloma) and all but three of the 13 cases of granuloma resolved. Product efficacy was rated satisfactory by 95% of the patients and physicians. CONCLUSIONS: This study demonstrated, in real-life conditions and on a large sample, that PLLA injections were feasible, efficient, and safe when performed by trained physicians.

Electronic versus paper-based assessment of health-related quality of life specific to HIV disease: reliability study of the PROQOL-HIV questionnaire.

BACKGROUND: Electronic patient-reported outcomes (PRO) provide quick and usually reliable assessments of patients' health-related quality of life (HRQL). OBJECTIVE: An electronic version of the Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV) questionnaire was developed, and its face validity and reliability were assessed using standard psychometric methods. METHODS: A sample of 80 French outpatients (66% male, 52/79; mean age 46.7 years, SD 10.9) were recruited. Paper-based and electronic questionnaires were completed in a randomized crossover design (2-7 day interval). Biomedical data were collected. Questionnaire version and order effects were tested on full-scale scores in a 2-way ANOVA with patients as random effects. Test-retest reliability was evaluated using Pearson and intraclass correlation coefficients (ICC, with 95% confidence interval) for each dimension. Usability testing was carried out from patients' survey reports, specifically, general satisfaction, ease of completion, quality and clarity of user interface, and motivation to participate in follow-up PROQOL-HIV electronic assessments. RESULTS: Questionnaire version and administration order effects (N=59 complete cases) were not significant at the 5% level, and no interaction was found between these 2 factors (P=.94). Reliability indexes were acceptable, with Pearson correlations greater than .7 and ICCs ranging from .708 to .939; scores were not statistically different between the two versions. A total of 63 (79%) complete patients' survey reports were available, and 55% of patients (30/55) reported being satisfied and interested in electronic assessment of their HRQL in clinical follow-up. Individual ratings of PROQOL-HIV user interface (85%-100% of positive responses) confirmed user interface clarity and usability. CONCLUSIONS: The electronic PROQOL-HIV introduces minor modifications to the original paper-based version, following International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ePRO Task Force guidelines, and shows good reliability and face validity. Patients can complete the computerized PROQOL-HIV questionnaire and the scores from the paper or electronic versions share comparable accuracy and interpretation.

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. Erectile or ejaculation difficulty, as well as low sexual desire, were investigated. SQoL was measured using the PROQOL-SexLife questionnaire. RESULTS: Most of participants reported low sexual desire, predominantly among MSM. Among MSM, living with a partner and healthcare satisfaction were associated with SQoL scores in POP dimension, while consistent condom use, cardiovascular complications, and being single were associated with SQoL scores in STI dimension. Viagra use, anti-cholesterol treatment, and living with a partner were associated with SQoL scores in DIS dimension. Among heterosexual men, employment and African origin were associated with SQoL scores in the POP dimension. Alcohol consumption was associated with SQoL scores in STI dimension. CONCLUSION: This study underscores the importance of non-clinical determinants when assessing SQoL among PLWHA, emphasizing psychological factors and the perceived quality of healthcare. Tailored interventions should incorporate these findings to enhance overall SQoL outcomes.

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. Participants were women with early breast cancer and healthcare professionals (General Practitioner homeopaths & oncologists). Inclusion depended on specific criteria and the aim of theoretical sampling until data saturation. Data were collected through individual semi-structured interviews and focus groups following evolving topic guides. Transcribed interviews underwent in-depth thematic analysis. Inclusion, interviewing, transcription and coding occurred iteratively. Data was reported according to COREQ guidelines. RESULTS: The therapeutic agency of homeopathy was distributed to different actors and ritualized material activities highly involving the patient. The choice of remedy was mostly delegated by patients to General Practitioner homeopaths (GPH) during consultations. Individualization, that is to say adaptation to the patient, differed from other modes of access to homeopathy (self-medication and oncologists). Self-medication was mostly limited to known products in a limited time frame. However, we identified a supported self-medication using trusted homeopathic protocols. Following homeopathic prescriptions involves a high level of commitment on behalf of the patient and follows different rules for homeopathy intake. This knowledge was either acquired earlier for users or discovered along breast cancer treatment for non-users. Taking homeopathy involved small daily actions for intake of different products at different times of the day. New users used strategies to ease the integration of homeopathy into their daily life. The stance toward such rules differed among patients. Some followed rules to optimize their effects while others simplified the rules and took those rituals as part of homeopathy benefits. CONCLUSION: Homeopathy as supportive care in breast cancer is distributed toward different actors and ritualized activities. Homeopathy is a supported practice where GPH played a role in the prescription. Health Literacy in homeopathy played a role to ease its integration into daily life and identify the potential benefits. The high involvement of patients in their homeopathic treatment is a form of treatment reappropriation and empowerment.