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.

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.

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. To minimise this risk and ensure that the treatments are assessed reliably, safety and/or efficacy criteria are monitored during the study by a Data Monitoring Committee. After receiving the results confidentially, the Data Monitoring Committee assesses the benefit/risk ratio of the study treatment and recommends that the trial be continued, modified or terminated. Data Monitoring Committee members issuing these recommendations have an important responsibility: a hasty decision to end the trial may lead to inconclusive results unable to answer the initial question and, inversely, delaying the decision to end the trial may expose the subjects to potentially ineffective or even harmful interventions. The Data Monitoring Committee's task is therefore particularly complex. With this in mind, the round table discussion at the Giens workshops was a chance to review the scientific justification for creating Data Monitoring Committees and to recall the need for their members to receive comprehensive training on the complexities of multiple analyses, confidentiality requirements applying to the results and the need for them to be aware that recommendations to end a trial must be based on data that is robust enough to assess the benefit/risk ratio of the treatment studied.

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. The use of interpreters to establish communication with patients having limited French proficiency (LFP) however, is often not used and can be problematic. Despite being offered, interpretation services are frequently underutilised, which makes communication challenging. This problem has not received enough attention in the literature, particularly in a technologically advanced setting where solutions may be found. Our objective was to explore how interpreters are used within the context of medical consultations when RDT for HIV, HBV, and HCV is offered to legal migrants with LFP. A cross-sectional qualitative study was used with a purposive sample that included doctors and nurses who had conducted rapid screening tests with migrants in four centers in France and who had access to interpretive services. Semi-structured interviews explored healthcare providers' (HP) use of interpreters at the OFII. The use of professional or ad hoc interpreters, telephone interpreters, and the equivalence of concepts such as health literacy between the HP and the interpreter were explored. The utility of a new tool to promote communication concordance was evaluated. Twenty interviews were conducted with eleven doctors and nine nurses with a median age of 58 years (25-67 years). All participants had access to interpretive services although many did not solicit them because of 1) unawareness on how to use the services, 2) preconceived notions of the length of time to involve an interpreter and how this would add to consultation times, or 3) the proximity of an ad hoc interpreter. Not using interpreter services could result in RDTs not being offered to immigrants. Subjects such as confidentiality, the embarrassment of a third party's presence, the lack of appropriate training and differing levels of health literacy were also discussed by participants. Insight from HPs allows us to better understand how both telephone and in-person interpretation are used, viewed, and why they are underused to communicate with limited French language skills patients. Our findings will help us develop a conceptual model for a digital communication tool to overcome barriers with migrant patients with limited French language skills.

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.

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. Furthermore, clinicians often call upon ad hoc interpreters, which introduces complexities in the clinical relationship. Digital solutions exist to diminish the burden of language barriers; however, the challenges of developing a multilingual and multicultural app have yet to be documented with respect to RDT in the nonfrancophone migrant population in France. OBJECTIVE: Our goal was to design a multilingual app to overcome language barriers, health literacy barriers, and fears related to being tested to promote RDT of HIV, HBV, and HCV in the nonfrancophone migrant population in France. METHODS: A combination of qualitative methods, agile development, and user-centered design was used. We conducted 2 focus groups (FGs) with 12 participants, including physicians, nurses, and social workers conducting RDT, as well as 1 modified Delphi survey with 68 participants including physicians and nurses. FGs explored the content (risk factors and medical history), functions (cultural adaptation and instant translation), and interface ergonomics (graphics and font) needed in the app. The Delphi presented 95 content items that the researchers sought to include in the app. RESULTS: Using FGs to inform the Delphi survey, we scientifically determined the app's content consisting of 95 items using expert consensus, developed a mock-up, and conducted initial user testing. We created an app that contains both migrant and clinician interfaces and includes a sociodemographic, risk assessment, health literacy, and testing barrier questionnaires available in 11 languages. Educational content is related to HIV, HBV, and HCV, along with the ability to understand whether the migrant agrees to be tested. CONCLUSIONS: This study allowed us to conceptualize a multilingual app that aims to increase the acceptance of RDT for HIV, HBV, and HCV. The specific features of the Assistant intelligent au dépistage des allophones app were designed to overcome the testing barriers in the nonfrancophone migrant population. The next phase will be an implementation study, as we intend to validate our app.

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. Both groups considered general practitioners, pharmacists and physiotherapists to be first-line HPs, and no well-defined OA specialist was identified. Patients and HPs reported similar difficulties concerning the adaptation of management to individual cases, late diagnosis and treatment, whereas only patients mentioned financial issues. Communication difficulties were identified as a major problem both between patients and HPs, and between HPs. Patients reported a lack of knowledge concerning pain and OA. The coordination between the various HPs is required, with education on both pain and OA. Several possible solutions were put forward by both patients and HPs. CONCLUSION: The care pathways of patients with painful OA are complex, with an unclear definition of the roles of the various HPs and suboptimal coordination. The role of HPs should be defined and collaboration between HPs developed.

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). All analyses were performed according to treatment duration prior to inclusion. Results: Among the 275/277 analyzed children, 166 (60.4%) had only growth hormone deficiency (GHD). In the GHD group, the mean age was 11.7 ± 3.2 years; median treatment duration was 3.3 years (interquartile range 1.8-6.4). The mean overall life interference total score was 27.7 ± 20.7 (95% CI (24.2; 31.2)), with non-significant correlation with treatment duration (P = 0.1925). Treatment adherence was good (95.0% of children reported receiving >80% of planned injections over the last month); it slightly decreased with treatment duration (P = 0.0364). Children's overall QOL was good (81.5 ± 16.6 and 77.6 ± 18.7 according to children and parents, respectively), but subscores of the coping and treatment impact domains were <50. Similar results were observed in all patients independently of the condition requiring treatment. Conclusions: This real-life French cohort confirms the treatment burden of daily growth hormone injections, as previously reported in an interventional study.

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. In the development and adoption of new technology, expectations play an important role. OBJECTIVE: This study aimed to explore health care professionals' opinions and attitudes regarding their screening practices with migrants and their expectations for a new communication tool that could improve migrants' screening use. METHODS: In this qualitative study, a purposive (diverse) sampling method was used to invite doctors and nurses who conduct rapid screening tests with migrants from 4 centers of the French Office of Immigration and Integration in 3 geographic regions of France. Semistructured interviews were conducted to survey their opinions on the rapid testing of migrants, the use of telephone interpreters, the concept of health literacy, and their expectations of a new communication tool that could overcome language barriers and promote rapid screening in the new migrant population. RESULTS: In all, 20 interviews were conducted with 11 doctors and 9 nurses with a median age of 58 (range 25-67) years. Participants favored the integration of an innovative communication tool in the context of rapid screening of migrants. However, there were concerns related to the implementation and added value of the tool while migrants were already reluctant to be screened. Expectations were for a tool that would present information in simplified French or a chosen language but also supports a positive attitude toward screening. Health professionals also expressed the wish that the technology could help with the collection of health data. CONCLUSIONS: Feedback from health professionals provides a better understanding of potential formats, characteristics, functions, content, and use of an innovative, digital method to communicate with migrants with limited French proficiency. Findings contribute to the conceptual development of an electronic app and its implementation within the ApiDé study, which aims to validate a digital app to address language barriers to increase the use of screening among migrants with limited French proficiency in France.

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.

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. PROQoL-SQoL consists of four dimensions: positive sexual perception (Psp), stigma and social distress (Sti), soft sexual practices (Sof), sexual practices with a partner (Sp), all of which were scored from 0 to 100 and considered as main outcomes, lower scores mean better sexual quality of life. Linear mixed effects models were used to evaluate the association with sociodemographic and psychosocial factors. RESULTS: Of the participants analyzed, 191 were living with HCV, 180 with HIV and 33 with HIV and HCV, median age was 48. Among WHIV, a higher satisfaction with health care, and talking about sexuality with healthcare workers were associated with lower scores in all the dimensions of the SQoL, while psychoactive substance use was associated with lower scores of Sti and Sof. Moreover, higher satisfaction with health care, talking about sexuality with healthcare workers, and psychoactive substance use (except cocaine use) in WHCV were associated with lower scores in Psp, Sti, and Sof. Besides, cocaine use was associated with higher scores of Sof. CONCLUSION: This study highlighted strong relationship between the quality of health care, and psychoactive substance use (except cocaine) and the sexual quality of life in WHIV and WHCV in these five countries. These findings draw attention to the different interventions that can be proposed for improving the sexual quality of life.

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. The round table was also an opportunity to discuss the complexity of sponsorship and data management related to the multiplicity of partners, funding, and governance of these trials, and the level of acceptability of their findings by the competent authorities.

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. METHODS: Participants provided clinical data and completed a self-administered questionnaire including sociodemographic variables and behaviors during the 6 previous months. We used multivariable logistic regression to identify factors associated with asymptomatic STIs. We calculated the accuracy of the model by the non-parametric area (AUC) under the receiver-operating-characteristic (ROC) curve to find the optimal discriminant threshold for screening. RESULTS: A total of 781 HIV-positive MSM were included with a mean age of 46.8 years. Asymptomatic STI prevalence was 13.2%. Detectable plasma HIV RNA (adjusted odds ratio (aOR [95% CI): 2.54 [1.23;5.25]), inconsistent condom use during anal sex (2.20 [1.36;3.56]), group sex (2.00 [1.15;3.45]), during or-genital practices (1.83 [1.12;3.01]), not being in stable relationship (1.70 [1.01;2.66] and an item from a sensation-seeking behavioral scale "I don't like watching porn videos" (1.61 [1.01;2.59] were associated with asymptomatic STI. AUC was 0.7 and with optimal threshold of 0.1082 for this model; sensitivity was 80.4%. Self-reported asymptomatic STI predictive score was built with this threshold according to the 6 factors in the final model. CONCLUSIONS: As this predictive score is not designed to be diagnostic, but to provide indications for diagnostic tests, its ease of administration and sensitivity remain the most important features. Its use in clinical practice for early detection of asymptomatic STIs potentially can reinforce STI primary and secondary prevention.

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

Introduction: 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. Objective: To provide multidisciplinary perspectives (patient, pharmaceutical industry, PRO researcher, regulatory expert) on PRO data in oncology drug labels. Methods: PRO data in the labels of drugs approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for oncology indications between 2010 and 2020 were critically reviewed by authors who provided their insights on the advantages and disadvantages/gaps. Results: Forty-six oncology drugs included PRO data in their labels. Differences were observed between FDA and EMA PRO labeling (e.g., PRO concept, use of tables and graphs to display PROs or reference to clinical meaningfulness). In providing their perspectives on the number and nature of PROs in labels, authors noted limitations including: the low proportion of oncology drugs with PRO labeling, limited PRO information in labels, lack of patient-friendly language, and potential bias towards positive outcomes. Lack of consistency within- and between-agencies was noted. Conclusion: Despite regulatory agencies' commitment to incorporate patient voices in regulatory decisions, availability of PRO information is limited in oncology drug labels. While several PRO guidance documents are available from regulatory and Health Technology Assessment agencies, harmonization of PRO guidance for labeling inclusion around the world is needed to better inform prescribers and consequently their patients in the process of shared medical decisions.

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 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.

Smoking increases the risk of post-acute COVID-19 syndrome: Results from a French community-based survey.

INTRODUCTION: We aimed to estimate the prevalence and incidence of specific symptoms and predictors of post-acute COVID-19 syndrome using data collected from an anonymous online survey. METHODS: We included adult participants with symptoms ≥60 days (D60+), fulfilling the World Health Organization COVID-19 cases definition, and/or hospitalized for COVID-19 at the time of infection (D0). Self-reported symptoms were collected at D0 and D60+. Logistic regression was performed to identify factors associated with self-reported cutaneous signs prevalence and self-reported tachycardia and/ or HBP incidence on D60+. RESULTS: From April to June 2020, 956 members of a Twitter long-term COVID-19 community were included in the study population: 81% were women, 81% were aged <50 year, 22% were smokers, and 95% have never been hospitalized. At D60+, the 956 participants reported a broad spectrum of symptoms which were also present at D0+. At D60+, 16% and 39% of participants reported cutaneous signs and tachycardia and/or hypertension, respectively. The incidence of self-reported tachycardia and/or hypertension at D60+ was 12%. Female gender (AOR=2.56; 95% CI: 1.22-6.1) and smoking (AOR=2.34; 95% CI: 1.39-3.92) were associated with prevalence of cutaneous signs at D60+. Smoking (AOR=2.05; 95% CI: 1.2- 3.47) was the main correlate of tachycardia and/or HBP incidence at D60+. CONCLUSIONS: The incidence of self-reported tachycardia and/or hypertension is not negligible and suggests an interaction between COVID-19 and smoking. Reinforcing symptoms monitoring of people after acute COVID-19, mainly women and smokers, and expanding the promotion of smoking cessation strategies are novel priorities in this COVID-19 era.

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.