Assessing a New Prescreening Score for the Simplified Evaluation of the Clinical Quality and Relevance of eHealth Apps: Instrument Validation Study.

BACKGROUND: In 2020, more than 250 eHealth solutions were added to app stores each day, or 90,000 in the year; however, the vast majority of these solutions have not undergone clinical validation, their quality is unknown, and the user does not know if they are effective and safe. We sought to develop a simple prescreening scoring method that would assess the quality and clinical relevance of each app. We designed this tool with 3 health care stakeholder groups in mind: eHealth solution designers seeking to evaluate a potential competitor or their own tool, investors considering a fundraising candidate, and a hospital clinician or IT department wishing to evaluate a current or potential eHealth solution. OBJECTIVE: We built and tested a novel prescreening scoring tool (the Medical Digital Solution scoring tool). The tool, which consists of 26 questions that enable the quick assessment and comparison of the clinical relevance and quality of eHealth apps, was tested on 68 eHealth solutions. METHODS: The Medical Digital Solution scoring tool is based on the 2021 evaluation criteria of the French National Health Authority, the 2022 European Society of Medical Oncology recommendations, and other provided scores. We built the scoring tool with patient association and eHealth experts and submitted it to eHealth app creators, who evaluated their apps via the web-based form in January 2022. After completing the evaluation criteria, their apps obtained an overall score and 4 categories of subscores. These criteria evaluated the type of solution and domain, the solution's targeted population size, the level of clinical assessment, and information about the provider. RESULTS: In total, 68 eHealth solutions were evaluated with the scoring tool. Oncology apps (22%, 20/90) and general health solutions (23%, 21/90) were the most represented. Of the 68 apps, 32 (47%) were involved in remote monitoring by health professionals. Regarding clinical outcomes, 5% (9/169) of the apps assessed overall survival. Randomized studies had been conducted for 21% (23/110) of the apps to assess their benefit. Of the 68 providers, 38 (56%) declared the objective of obtaining reimbursement, and 7 (18%) out of the 38 solutions seeking reimbursement were assessed as having a high probability of reimbursement. The median global score was 11.2 (range 4.7-17.4) out of 20 and the distribution of the scores followed a normal distribution pattern (Shapiro-Wilk test: P=.33). CONCLUSIONS: This multidomain prescreening scoring tool is simple, fast, and can be deployed on a large scale to initiate an assessment of the clinical relevance and quality of a clinical eHealth app. This simple tool can help a decision-maker determine which aspects of the app require further analysis and improvement.

Profound Defect of Amphiregulin Secretion by Regulatory T Cells in the Gut of HIV-Treated Patients.

The persistence of a leaky gut in HIV-treated patients leads to chronic inflammation with increased rates of cardiovascular, liver, kidney, and neurological diseases. Tissue regulatory T (tTreg) cells are involved in the maintenance of intestinal homeostasis and wound repair through the IL-33 pathway. In this study, we investigated whether the persistence of gut mucosal injury during HIV infection might be explained in part by a flaw in the mechanisms involved in tissue repair. We observed an increased level of IL-33 in the gut of HIV-infected patients, which is associated with an increased level of fibrosis and a low peripheral reconstitution of CD4+ T cells. Our results showed that intestinal Treg cells from HIV-infected patients were enriched in tTreg cells prone to support tissue repair. However, we observed a functional defect in tTreg cells caused by the lack of amphiregulin secretion, which could contribute to the maintenance of intestinal damage. Our data suggest a mechanism by which the lack of amphiregulin secretion by tTreg may contribute to the lack of repair of the epithelial barrier.

Early Detection of Neurodevelopmental Disorders of Toddlers and Postnatal Depression by Mobile Health App: Observational Cross-sectional Study.

BACKGROUND: Delays in the diagnosis of neurodevelopmental disorders (NDDs) in toddlers and postnatal depression (PND) in mothers are major public health issues. In both cases, early intervention is crucial. OBJECTIVE: We aimed to assess if a mobile app named Malo can reduce delay in the recognition of NDD and PND. METHODS: We performed an observational, cross-sectional, data-based study in a population of young parents with a minimum of 1 child under 3 years of age at the time of inclusion and using Malo on a regular basis. We included the first 4000 users matching the criteria and agreeing to participate between November 11, 2021, and January 14, 2022. Parents received monthly questionnaires via the app, assessing skills on sociability, hearing, vision, motricity, language of their infants, and possible autism spectrum disorder. Mothers were also requested to answer regular questionnaires regarding PND, from 4-28 weeks after childbirth. When any patient-reported outcomes matched predefined criteria, an in-app notification was sent to the user, recommending the booking of an appointment with their family physician or pediatrician. The main outcomes were the median age of the infant at the time of notification for possible NDD and the median time of PND notifications after childbirth. One secondary outcome was the relevance of the NDD notification for a consultation as assessed by the physicians. RESULTS: Among 4242 children assessed by 5309 questionnaires, 613 (14.5%) had at least 1 disorder requiring a consultation. The median age of notification for possible autism spectrum, vision, audition, socialization, language, or motor disorders was 11, 9, 17, 12, 22, and 4 months, respectively. The sensitivity of the alert notifications of suspected NDDs as assessed by the physicians was 100%, and the specificity was 73.5%. Among 907 mothers who completed a PND questionnaire, highly probable PND was detected in 151 (16.6%) mothers, and the median time of detection was 8-12 weeks. CONCLUSIONS: The algorithm-based alert suggesting NDD was highly sensitive with good specificity as assessed by real-life practitioners. The app was also efficient in the early detection of PND. Our results suggest that the regular use of this multidomain familial smartphone app would permit the early detection of NDD and PND. TRIAL REGISTRATION: ClinicalTrials.gov NCT04958174; https://clinicaltrials.gov/ct2/show/NCT04958174.

Frequency and risk factors of severe postoperative bleeding after proctological surgery: a retrospective case-control study.

PURPOSE: The aim of this study was to assess frequency and risk factors of severe bleeding after proctological surgery requiring hemostatic surgery observed after publication of the French guidelines for anticoagulant and platelet-inhibitor treatment. METHODS: All patients who underwent proctological surgery between January 2012 and March 2017 in a referral center were included. Delay, severity of bleeding, and need for blood transfusion were recorded. Patients with severe postoperative bleeding were matched to controls at a 2:1 ratio adjusted on the operator, and the type of surgery. RESULTS: Among the 8,890 operated patients, 65 (0.7%) needed a postoperative hemostatic procedure in an operating room. The risk of a hemostatic surgery was significantly increased after hemorrhoidal surgery compared with other procedures (1.9% vs. 0.5%, P<10-4) and was most frequent after Milligan-Morgan hemorrhoidectomy (2.5%). Mean bleeding time was 6.2 days and no bleeding occurred after day 15. Blood transfusion rate was 0.1%. Treatment with anticoagulants and platelet inhibitors were managed according to recommendations and did not increase the severity of bleeding. The risk of severe bleeding was significantly lower in active smokers vs. non-smokers in univariate (16.9% vs. 36.2%, P=0.007) and multivariate (odds ratio, 0.31; 95% confidence interval, 0.14-0.65) analysis whereas sex, age, and body mass were not significantly associated with bleeding. CONCLUSION: Severe postoperative bleeding occurs in 0.7% of patients, but varies with type of procedure and is not affected by anticoagulant or antiplatelet treatment. These treatments given in accordance with the new guidelines do not increase the severity of postoperative bleeding.

Reciprocal association between voting and the epidemic spread of COVID-19: observational and dynamic modeling study.

BACKGROUND: Whether voting is a risk factor for epidemic spread is unknown. Reciprocally, whether an epidemic can deter citizens from voting has not been often studied. We aimed to investigate such relationships for France during the coronavirus disease 19 (COVID-19) epidemic. METHODS: We performed an observational study and dynamic modelling using a sigmoidal mixed effects model. All hospitals with COVID-19 patients were included (18 March 2020-17 April 2020). Abstention rate of a concomitant national election was collected. RESULTS: Mean abstention rate in 2020 among departments was 52.5% ± 6.4% and had increased by a mean of 18.8% as compared with the 2014 election. There was a high degree of similarity of abstention between the two elections among the departments (P < 0.001). Among departments with a high outbreak intensity, those with a higher participation were not affected by significantly higher COVID-19 admissions after the elections. The sigmoidal model fitted the data from the different departments with a high degree of consistency. The covariate analysis showed that a significant association between participation and number of admitted patients was observed for both elections (2020: ß = -5.36, P < 1e-9 and 2014: ß = -3.15, P < 1e-6) contradicting a direct specific causation of the 2020 election. Participation was not associated with the position of the inflexion point suggesting no effect in the speed of spread. CONCLUSIONS: Our results suggest that the surrounding intensity of the COVID-19 epidemic in France did not have any local impact on participation to a national election. The level of participation had no impact on the spread of the pandemic.

Predicting the propagation of COVID-19 at an international scale: extension of an SIR model.

OBJECTIVES: Several epidemiological models have been published to forecast the spread of the COVID-19 pandemic, yet many of them have proven inaccurate for reasons that remain to be fully determined. We aimed to develop a novel model and implement it in a freely accessible web application. DESIGN: We built an SIR-type compartmental model with two additional compartments: D (deceased patients); L (individuals who will die but who will not infect anybody due to social or medical isolation) and integration of a time-dependent transmission rate and a periodical weekly component linked to the way in which cases and deaths are reported. RESULTS: The model was implemented in a web application (as of 2 June 2020). It was shown to be able to accurately capture the changes in the dynamics of the pandemic for 20 countries whatever the type of pandemic spread or containment measures: for instance, the model explains 97% of the variance of US data (daily cases) and predicts the number of deaths at a 2-week horizon with an error of 1%. CONCLUSIONS: In early performance evaluation, our model showed a high level of accuracy between prediction and observed data. Such a tool might be used by the global community to follow the spread of the pandemic.

Increased Long-term Risk of Anal Fistula After Proctologic Surgery: A Case-Control Study.

PURPOSE: Anal fistula is a common condition in proctology, usually requiring surgical treatment. Few risk factors have been clearly identified based on solid evidence. Our research objective was to determine whether history of anal surgery was a risk factor for subsequent anal fistula. METHODS: We conducted a case-control study from January 1, 2012 through December 31, 2013 in our tertiary center, comprising 280 cases that underwent surgery for anal fistula and 123 control patients seeking a consultation for upper gastrointestinal symptoms. Patients with inflammatory bowel disease were excluded. For both cases and controls, the following variables were recorded: sex, any prior anal surgery, diabetes mellitus, infection with human immunodeficiency virus, and smoking status. For each variable, confidence interval and odds ratio (OR) were calculated. RESULTS: In univariate analysis, male sex (73.2% vs. 31.7%, P < 0.0001), active smoking (38.1% vs. 22%, P = 0.0015), and prior anal surgery (16.0% vs. 4.1%, P = 0.0008) were associated with higher risk of anal fistula. In multivariate analysis, only male sex (OR, 5.5; 95% confidence interval [CI], 5.42 to 9.10; P < 0.0001) and previous anal surgery (OR, 4.48; 95% CI, 1.79 to 13.7; P = 0.0008) remained independently associated with anal fistula occurrence. CONCLUSION: The epidemiology of anal fistula is poorly assessed despite the high frequency at which it is diagnosed. Our findings suggest that history of any kind of anal surgery is a risk factor for further onset of anal fistula. Surgeons and patients must be informed of this issue.

Long-term efficacy of fibrin glue injection for perianal fistulas in patients with Crohn's disease.

AIM: The treatment of perianal fistulas in Crohn's disease remains challenging. Fibrin glue injection has previously shown short-term efficacy in a randomized controlled trial. No long-term data are available to assess the benefit of this treatment. METHODS: This retrospective multicentre study included all patients with drained fistulas treated by at least one fibrin glue injection between January 2004 and June 2015 in three tertiary French centres. The primary end-point was the rate of complete clinical remission at 1 year after injection defined by the closure of all fistula tracts with no need for iterative anal surgery or for optimization of immunosuppressants and/or biologics. RESULTS: In all, 119 patients (median age 33 years, complex fistulas 65%, median previous anal surgery two, median Harvey Bradshaw score 3, immunosuppressants exposure 50%, anti-tumor necrosis factor exposure 60% with median time of administration of 1.1 year) were analysed with a median follow-up of 18.3 months. The complete clinical remission rate at 1 year was 45.4%. The primary end-point was achieved in 63% of the cases in the combination therapy group and 37% in other patients. The only predictor of complete clinical remission at 1 year was combination therapy at the time of injection (P = 0.01). The rate of early reintervention after glue injection was 2.5%. The cumulative incidence of iterative anal surgery and ostomy in the whole population was 54% and 5.6% respectively at 5 years. CONCLUSION: An adjunct of fibrin glue to conventional medical therapy may be an effective and safe treatment for perianal fistulas in patients with Crohn's disease.

Patients' Perceptions and Preferences Regarding Two Different Forms of Methotrexate Autoinjectors for Moderate to Severe Rheumatoid Arthritis: A European Crossover Survey.

PURPOSE: Treatment adherence is crucial in patients with rheumatoid arthritis (RA). The device used by the patients for self-injections may influence adherence to methotrexate (MTX) treatment. A MTX-autoinjector has been recently marketed in Europe. This crossover survey compared this MTX-autoinjector (MTX-autoinjector A) and an already existing MTX-autoinjector (MTX-autoinjector B) from the patients' perspective. PATIENTS AND METHODS: A total of 100 patients with moderate to severe RA using MTX-autoinjector A (N=35) or MTX-autoinjector B (N=65) were interviewed by an independent Global Market Research Company. Face-to-face interviews were performed using a computer-assisted personal interview system. Evaluation of the unfamiliar MTX-autoinjector was performed once the patients had received information, seen a demonstration, and performed a virtual testing. RESULTS: A substantial advantage in favor of the MTX-autoinjector A was found with respect to all surveyed indicators. Respectively, 95% and 55% of the users of MTX-autoinjectors A and B claimed to be very or totally satisfied with their familiar MTX-autoinjector. With respect to several specific characteristics, 91% and 60% of the users of MTX-autoinjectors A and B were very or totally satisfied with their familiar MTX-autoinjector, 29% and 77% found the unfamiliar MTX-autoinjector better, and 26% and 73% were interested in trying the unfamiliar MTX-autoinjector. Injection mode (with no push button) and end-of-injection recognition system (with audible signal) were identified as key features explaining a stronger preference for MTX-autoinjector A. CONCLUSION: Even though deserving further studying, these findings are expected to guide clinicians when prescribing or renewing prescription of MTX-autoinjector, in particular in poor or non-compliant patients. In a context of growing interest in shared decision-making, the objective would be to choose with each patient the best suited MTX-autoinjector, and ultimately, to obtain a better treatment adherence.

Human papillomavirus vaccine uptake among men in France: a national time series analysis for 2015-2018.

While national authorities recommended and provided reimbursement for men who have sex with men under 27 in 2016 and 2017, respectively, we aimed to comprehensively analyze human papillomavirus (HPV) vaccine uptake in French men over a 4-year period surrounding these changes. Data regarding HPV vaccine sales to men in all French pharmacies from 2015 through 2018 were retrieved through query made to the national public insurance database. Data were classified according to the age of patients and the time of dispensation so as to display aggregate uptake according to age over time. Time-series analysis was conducted and an exponential smoothing extrapolation was selected to analyze the impact of the reimbursement. Overall, 12,814 HPV vaccines were dispensed in men over the study period. Age was available for the majority of cases (12,793; 99.8%), averaging 29. Dispensation data for each year were the following: 1,917 (2015), 1,921 (2016), 2,643 (2017), 6,312 (2018). Age analysis showed that vaccine uptake among men over 26 was substantial (n = 5974; 46.7%). The exponential increase in the number of vaccines sold started after the second quarter of 2017. In conclusion, we found that HPV vaccine uptake among French men is partly misaligned with recommendations and reimbursement in terms of age, and still moderate overall even though we found signs of marked increase in uptake over the most recent period, suggesting an effective impact of insurance coverage.

Health as an independent predictor of the 2017 French presidential voting behaviour: a cross-sectional analysis.

BACKGROUND: It has been suggested that poor health has influenced vote for Brexit and the US presidential election. No such research has been published regarding the 2017 French presidential election. METHODS: We performed a cross-sectional analysis using a comprehensive set of socioeconomic and health indicators, to be compared with voting outcome at the first round of the 2017 French presidential election. The 95 French departments were selected as the unit of analysis. Data were obtained from publicly available sources. The linear model was used for both univariate and multivariate analysis to investigate the relation between voting patterns and predictors. Sensitivity analyses were done using the elastic-net regularisation. RESULTS: Emmanuel Macron and Marine Le Pen arrived ahead. When projected on the first factorial plane (~ 60% of the total inertia), Emmanuel Macron and Marine Le Pen tended to be in opposite directions regarding both socioeconomic and health factors. In the respective multivariate analyses of the two candidates, both socio-economic and health variables were significantly associated with voting patterns, with wealthier and healthier departments more likely to vote for Emmanuel Macron, and opposite departments more likely to vote for Marine Le Pen. Mortality (p = 0.03), severe chronic conditions (p = 0.014), and diabetes mellitus (p < 0.0001) were among the strongest predictors of voting pattern for Marine Le Pen. Sensitivity analyses did not substantially change those findings. CONCLUSIONS: We found that areas associated with poorer health status were significantly more likely to vote for the far-right candidate at the French presidential election, even after adjustment on socioeconomic criteria.

Comparison of 20-gauge Procore® and 22-gauge Acquire® needles for EUS-FNB of solid pancreatic masses: an observational study.

Background and Aims: Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) has been proposed to obtain high-quality tissue samples for pancreatic tumors. We performed an observational study to compare EUS-FNB with a 20-gauge Procore® needle versus a 22-gauge Acquire® needle. Our primary endpoint was the quantity of the obtained tissue, as defined by the mean cumulative length of tissue core biopsies per needle pass. Methods: Sixty-eight EUS-FNB were consecutively performed on patients with a pancreatic mass. The choice of needle depended on availability at the time of admission: 34 punctures were performed with each needle. Histological material was studied in a blinded manner with respect to the needle, and the cumulative length of tissue core biopsies per needle pass was determined. Intraobserver and interobserver variability of this criterion was then evaluated. Results: There were no between-group differences. Histological diagnosis was achieved and core biopsy specimens were obtained in 28 out of 34 patients (82%) in the 20-gauge Procore® group and in 33 out of 34 patients (97%) in the 22-gauge Acquire® group (p = .1). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22-gauge Acquire® needle with 8.2 ± 4.2 mm versus 4.2 ± 3.8 mm for the 20-gauge Procore® needle (p < .01). No intra and inter-observer variability of this criterion was observed. Conclusions: Our results suggest significant differences, with a mean cumulative length of tissue core biopsies per needle pass significantly higher with the 22-gauge Acquire® needle. This simple criterion seems reliable and reproducible.

[Anal fissure]. / Fissure anale.

Anal fissure. Anal fissure is a painful proctological disease that most often affects young patients equally in both sexes. It significantly worsens the quality of life and requires rapid care. The anal fissure is most often located in the posterior anal commissure and frequently surmounted by a skin tag which can hide it and wrongly carry the diagnosis of hemorrhoids. Differential diagnoses such as carcinoma, Crohn's disease, sexually transmitted infection, etc. should be mentioned in case of atypical presentation. Its pathophysiology remains controversial, but in most cases, it results from the trauma of the passage of hard stools on an hypertonic anus. Medical treatment can cure just over half of patients. Surgery is reserved for failures of medical treatment and hyperalgesic fissure. In France, fissurectomy is the most commonly performed procedure while on the other side of the Channel or the Atlantic, lateral internal sphincterotomy is considered as the reference technique.

Fissure anale. La fissure anale est une pathologie proctologique douloureuse qui atteint le plus souvent le sujet jeune de manière équivalente dans les deux sexes. Elle altère significativement la qualité de vie et nécessite une prise en charge rapide. La fissure est le plus souvent située au niveau de la commissure anale postérieure et fréquemment surmontée par un capuchon mariscal qui peut la cacher et faire porter à tort le diagnostic de pathologie hémorroïdaire. Des diagnostics différentiels comme un carcinome, une maladie de Crohn, une infection sexuellement transmise, etc., doivent être évoqués en cas de présentation atypique. La physiopathologie reste un sujet de controverse mais elle résulte dans la grande majorité des cas de la conjonction du traumatisme du passage de selles dures et d'une contracture sphinctérienne avec hypertonie anale de repos. Le traitement médical permet de guérir un peu plus de la moitié des patients. La chirurgie est réservée aux échecs du traitement médical et aux fissures hyperalgiques. En France, la fissurectomie est le geste le plus pratiqué alors que de l'autre côté de la Manche ou de l'Atlantique, la sphinctérotomie latérale interne est considérée comme la technique de référence.