[Secondary use of data: The promise of artificial intelligence]. / L'utilisation secondaire des données : les promesses de l'intelligence artificielle.

The use of secondary healthcare data contributes to improving the healthcare system and, for the patient in particular, aims to provide better care thanks to the lessons learned from compiling the information. This article, using the example of an artificial intelligence (AI) project called Hydro, highlights the importance and challenges of cross-fertilizing different data sources, to help find solutions that enrich the healthcare offering.

[The first data challenge of the french society of pathology: An international competition in 2020, a research tool in A.I. for the future?] / Le premier data challenge organisé par la Société Française de Pathologie : une compétition internationale en 2020, un outil de recherche en intelligence artificielle pour l'avenir ?

The french society of pathology (SFP) organized in 2020 its first data challenge with the help of Health Data Hub (HDH). The organisation of this event first consisted in recruiting almost 5000 slides of uterus cervical biopsies obtained in 20 pathology centers. After having made sure that patients did not refuse to include their slides in the project, the slides were anonymised, digitized and annotated by expert pathologists, and were finally uploaded on a data challenge platform for competitors all around the world. Competitors teams had to develop algorithms that could distinguish among four diagnostic classes in epithelial lesions of uterine cervix. Among many submissions by competitors, the best algorithms obtained an overall score close to 95%. The best 3 teams shared 25k€ prizes during a special session organised during the national congress of the SFP. The final part of the competition lasted only 6 weeks and the goal of SFP and HDH is now to allow for the collection to be published in open access. This final step will allow data scientists and pathologists to further develop artificial intelligence algorithms in this medical area.

The French Health Data Hub and the German Medical Informatics Initiatives: Two National Projects to Promote Data Sharing in Healthcare.

OBJECTIVE: The diversity and volume of health data have been rapidly increasing in recent years. While such big data hold significant promise for accelerating discovery, data use entails many challenges including the need for adequate computational infrastructure and secure processes for data sharing and access. In Europe, two nationwide projects have been launched recently to support these objectives. This paper compares the French Health Data Hub initiative (HDH) to the German Medical Informatics Initiatives (MII). METHOD: We analysed the projects according to the following criteria: (i) Global approach and ambitions, (ii) Use cases, (iii) Governance and organization, (iv) Technical aspects and interoperability, and (v) Data privacy access/data governance. RESULTS: The French and German projects share the same objectives but are different in terms of methodologies. The HDH project is based on a top-down approach and focuses on a shared computational infrastructure, providing tools and services to speed projects between data producers and data users. The MII project is based on a bottom-up approach and relies on four consortia including academic hospitals, universities, and private partners. CONCLUSION: Both projects could benefit from each other. A Franco-German cooperation, extended to other countries of the European Union with similar initiatives, should allow sharing and strengthening efforts in a strategic area where competition from other countries has increased.

Surgical Outcomes of Newly Trained ShangRing Circumcision Providers.

BACKGROUND: Devices can potentially accelerate scale-up of voluntary medical male circumcision in sub-Saharan Africa. Studies have demonstrated advantages of the ShangRing device over conventional circumcision. With the need to train providers rapidly for scale-up, concerns arise about the transferability of techniques and the expertise of new trainees. METHODS: We compared outcomes of ShangRing circumcisions conducted in Kenya by experienced providers (experience with more than 100 ShangRing circumcisions) and newly trained providers (trained in Kenya by the experienced providers before the study began). During training, trainees performed at least 7 ShangRing circumcisions and 3 removals. Newly trained providers received intermittent clinical mentoring initially during the study but otherwise conducted circumcisions on their own. RESULTS: Four hundred six and 115 ShangRing procedures were performed by the new trainees and the experienced providers, respectively. The mean duration of circumcisions was 6.2 minutes for both trained and experienced provider groups (P = 0.45), whereas the mean pain score (on an 11-point scale) was 2.5 and 3.2, respectively (P = 0.65). There was no difference in the proportion of participants healed by the day 42 visit (P = 0.13) nor in the incidence of moderate and severe adverse events observed (P = 0.16). Participants in both groups were equally satisfied with final wound cosmesis. DISCUSSION: Results demonstrate that the ShangRing circumcision technique is easy to learn and master. Newly trained providers can safely conduct ShangRing circumcisions in routine service settings. The ShangRing can facilitate rapid rollout of voluntary medical male circumcision for HIV prevention in sub-Saharan Africa.

Men's Understanding of and Experiences During the Postcircumcision Abstinence Period: Results From a Field Study of ShangRing Circumcision During Routine Clinical Services in Kenya and Zambia.

BACKGROUND: Men's understanding of counseling messages after voluntary medical male circumcision (VMMC) plays an important role in whether they follow them. Data on triggers for early resumption of sex may be useful as scale-up of VMMC for HIV prevention continues in sub-Saharan Africa. METHODS: Data on understanding of post-VMMC abstinence recommendations, resumption of sex, condom use, and triggers for resuming sex were collected from participants during a follow-up interview 35-42 days after ShangRing circumcision in Kenya and Zambia. RESULTS: Of 1149 men who had ShangRing circumcision, 1096 (95.4%) completed follow-up. Nearly all (99.2%) reported being counseled to abstain from sex post-VMMC; among those, most (92.2%) recalled the recommended abstinence period was 6 weeks. Most men (94.1%) reported that the counselor gave reasons for post-VMMC abstinence and recalled appropriate reasons. Few (13.4%) men reported resuming sex at 35-42 days' follow-up. Among those, 54.8% reported never using a condom post-VMMC. Younger participants (odds ratio 0.3, 95% confidence interval: 0.2 to 0.5, P < 0.0001) and those reporting at least some condom use at baseline (odds ratio 0.5, 95% confidence interval: 0.3 to 0.7, P = 0.0003) were less likely to report resuming sex. Among men who reported some condom use, most (71.5%) said condoms were much easier or easier to use after circumcision. Men reported various reasons for early resumption of sex, primarily strong sexual desire (76.4%). CONCLUSIONS: Most men reported awareness of and adherence to the counseling recommendations for post-VMMC abstinence. A minority reported early resumption of sex, and, among those, condom use was low. Results could be used to improve post-VMMC counseling.

Factors Associated With Delayed Healing in a Study of the PrePex Device for Adult Male Circumcision in Kenya.

OBJECTIVES: To explore factors associated with healing requiring more than 6 weeks after placement of the PrePex device for adult medical male circumcision. METHODS: We enrolled 427 men ages 18-49 years in an observational study of PrePex at 1 urban and 2 peripheral clinics in western Kenya. Participants were scheduled for device removal at day 7 and a follow-up visit at day 42 (allowable range, 40-44) at which the provider recorded wound status, with complete healing defined as a dry wound without any scab, later confirmed by site investigator review of digital penile photographs. We performed univariate and multivariate logistic regression to explore associations between selected demographic, surgical, and follow-up factors and delayed healing (not healed by day 42 visit). RESULTS: Of the 427 men, 341 completing a day 42 visit with physical examination and recorded healing status were included. Fifty-four percent of included men were healed by day 42 visit. Factors associated with delayed healing in univariate analysis and remaining significant in the multivariate analysis were as follows: age 25 years or older [odds ratio (OR): 1.8; 95% confidence interval (CI): 1.4 to 2.4], an adverse event by day 44 (OR: 1.4; 95% CI: 1.03 to 2.0), and severe pain during device removal (protective association: OR: 0.7; 95% CI: 0.5 to 0.99). CONCLUSIONS: Older age (25+ years), occurrence of an adverse event, and lesser self-reported pain at device removal were associated with delayed wound healing. If confirmed by larger surveillance studies, these results should be incorporated into the counseling given to male circumcision clients.

Unexpected Complications Following Adult Medical Male Circumcision Using the PrePex Device.

INTRODUCTION: In this study, we describe and depict unexpected sequelae of adult medical male circumcision (MMC) using the PrePex device. MATERIALS AND METHODS: The PrePex system is an elastic compression device for adult MMC. The device is well studied, has been pre-qualified by the World Health Organization (WHO), and its use is being scaled-up in African countries targeted by WHO. We conducted a PrePex implementation study in routine service delivery among 427 men in the age range of 18-49 in western Kenya. We captured penile photographs to create a record of adverse events (AEs) and to monitor healing. Several unexpected AEs ensued, including some that have not been reported in other PrePex studies. We describe and depict those unexpected complications and resulting treatments to alert circumcision providers in the relevant areas. RESULTS: We observed 5 device displacements (1.2%); 3 cases of early sloughing of foreskin tissue (0.7%) among men with long foreskins; 2 cases of a long foreskin obstructing urine flow, as it became dry and necrotic (0.5%); and 2 cases of insufficient foreskin removal caused by invagination for which surgical completion was necessary (0.5%). All of the participants healed completely by day 42 post-circumcision or shortly thereafter. CONCLUSION: The potential for these complications should be incorporated into PrePex training programs. Integration of devices into MMC programs in medically underserved areas requires the availability of prompt surgical intervention for some sequelae, particularly displacement events.

[Thinking ethics education]. / Penser l'enseignement de l'éthique.

Ethics emerges in the interstices of deontology, in difficult situations generating internal conflicts for the caregiver, sources of anxiety and questioning. Ethics education has always played a major in nursing programs by initiating a reflection on human values. Faced with current uncertainties in the context of care, it is now based on the appropriation of a reflexive approach to the meaning of action.

Field study of adult male circumcision using the ShangRing in routine clinical settings in Kenya and Zambia.

BACKGROUND: Circumcision devices can facilitate adult voluntary medical male circumcision programs for HIV prevention. The World Health Organization recommends field studies to confirm the safety of devices in local settings. METHODS: We evaluated the safety of the ShangRing device in routine service delivery by measuring adverse event (AE) rates overall and by HIV status. We enrolled men aged 18-54 years and scheduled them for 2 post-circumcision follow-up visits at day 7 for device removal and days 35-42. Men were examined to document AEs and healing and to ascertain client acceptability. Provider preferences were also assessed. RESULTS: We enrolled 1163 men (557 in Kenya and 606 in Zambia); the as-treated analysis population comprised 1149 men, including 84 HIV-positive men. There were no serious AEs and 2 severe AEs: 1 severe wound dehiscence and 1 severe pain, both of which resolved with treatment. There were 18 moderate/severe AEs among 16 men (1.4% of men; 95% confidence interval: 0.8% to 2.3%). The most common AE was wound dehiscence (9 men, 0.8%). Healing was similar between HIV-infected and uninfected men, with 85.7% and 87.3% completely healed at days 35-42. Most men (94.8%) were very satisfied with post-circumcision appearance of the penis, and almost all would recommend a ShangRing procedure. Nineteen of 21 providers preferred the ShangRing over conventional surgery. CONCLUSIONS: The ShangRing has an excellent safety profile with few hemorrhagic and infectious complications. The ShangRing is well accepted by clients and preferred by providers, making it a potential boon to the scale-up of adult voluntary medical male circumcision in African countries.

Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya.

OBJECTIVE: To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya. METHODS: We enrolled 427 men ages 18-49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs) and time to complete healing, and interviewed men about acceptability and pain. RESULTS: Placement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%-8.5%), all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%). Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30-0.58), and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family. CONCLUSIONS: The PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates. TRIAL REGISTRATION: ClinicalTrials.gov NCT01711411.

Randomized controlled trial of the shang ring versus conventional surgical techniques for adult male circumcision: safety and acceptability.

OBJECTIVE: To compare clinical profiles of Shang Ring versus conventional circumcisions. DESIGN: Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites. METHODS: We enrolled HIV-negative men aged 18-54 years in Homa Bay, Kenya, and Lusaka, Zambia and followed them at 2, 7, 14, 21, 28, 42, and 60 days after Shang Ring versus conventional circumcision. We compared the duration of surgery, postoperative pain using a visual analog scale, adverse events rates, time to complete wound healing by clinical assessment, participant acceptability, and provider preferences between circumcision groups. RESULTS: We randomized 200 men to each group; 197 and 201 contributed to the Shang Ring and conventional surgery analyses, respectively. Adverse event rates were similar between groups. Pain scores at most time points were similar, however, the Shang Ring group reported higher scores for worst pain during erections (3.5 ± 1.9 vs. 2.3 ± 1.7; P < 0.001). Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision (MC), 95.7% versus 85.9% (P = 0.02) in Kenya, and 96.8% versus 71.3% (P < 0.01) in Zambia. Although median time to complete wound healing was 43 days in both groups, conventional circumcisions healed on average 5.2 days sooner (P < 0.001). Shang Ring procedures took one-third the time of conventional MC, 7 versus 20 minutes. All circumcision providers preferred the Shang Ring. CONCLUSIONS: Safety profiles of the 2 techniques were similar, all MC providers preferred the Shang Ring technique, and study participants preferred the Shang Ring's cosmetic results. The Shang Ring should be considered for adult MC as programs scale-up.

Pharmacokinetics of subcutaneous depot medroxyprogesterone acetate injected in the upper arm.

BACKGROUND: The abdomen and thigh are recommended injection sites in the label for Depo-SubQ Provera 104™. We evaluated the pharmacokinetic profile of medroxyprogesterone acetate (MPA) following injection of Depo-SubQ Provera 104 in the upper arm, a preferred injection site in developing countries. STUDY DESIGN: Twenty-six women in Norfolk, VA, received a single injection of Depo-SubQ Provera 104 in the upper arm in this prospective noncomparative study. We measured MPA serum concentrations prior to injection (day 1) and 11 times postinjection (days 2, 4, 8, 14, 30, 44, 60, 74, 91, 104 and 120). RESULTS: Serum MPA levels peaked at 0.953 ng/mL 2-14 days (interquartile range; median=8) after dosing. Mean AUC0-91 was 45.1 ng·day/mL. Mean MPA levels at days 91, 104 and 120 were 0.427, 0.367 and 0.327 ng/mL, respectively. A total of 15 individual measurements of MPA were below 0.2 ng/mL. All women but one had MPA levels above 0.1 ng/mL on day 91. CONCLUSIONS: Injection of Depo-SubQ Provera 104™ in the upper arm provided sufficient MPA levels for contraceptive protection for 3 months (13 weeks). The uptake and metabolism of MPA when injected in the upper arm may be different from the abdomen and thigh.

HIV prevalence and incidence among women at higher risk of infection in Addis Ababa, Ethiopia.

This study aimed to estimate HIV incidence among women at higher HIV risk in Addis Ababa, Ethiopia using cross-sectional data. To refine the estimate, we sought to determine a local correction factor by estimating a false recent rate for the BED assay. The overall study had two parallel phases: cross-sectional incidence and BED false recent (BED FR). A total of 1856 women at higher HIV risk were enrolled into the cross-sectional phase. For the BED FR, 500 women and 70 men with known HIV infection of greater than 12 months were enrolled. Rapid HIV tests were used to assess participant HIV status. Samples from women with positive results on HIV rapid testing were then analyzed using the BED assay to determine incident HIV infections. The overall HIV prevalence was 11.3%, with women greater than 25 years old having a higher prevalence (26.5% vs. 7.9% for younger women). The overall unadjusted HIV incidence was 3.3%. The estimated HIV incidence was 2.6% when adjusted using the locally derived false recent rate of 3.5%. Similar incidence rates were found between the younger and older age groups. This is one of the first field-based studies of HIV incidence in Ethiopia; it demonstrates that there is sufficient incidence to warrant further HIV prevention efforts among women at higher risk of HIV infection.