Comparison of the penile microbiome in infant male circumcision: Mogen clamp versus Shangring.

BACKGROUND: This study aimed to characterise the infant penile (coronal sulcus) microbiome and the effects of early infant male circumcision (EIMC), following a standard surgical method (Mogen Clamp) and a non-surgical alternative (ShangRing). METHODS: We collected coronal sulcus swabs at baseline and on days 7 and 14 post-circumcision from infants assigned to receive EIMC by Mogen Clamp (n = 15) or ShangRing (n = 15), in a randomised trial in Rakai and Kakuuto, Uganda. We used 16S rRNA gene-based sequencing and broad-coverage qPCR to characterise the infant penile microbiome and assess the effects of EIMC in both study arms. FINDINGS: Prior to EIMC, the infant penile microbiome had a mixture of facultative and strict anaerobes. In both study arms, EIMC caused penile microbiome proportional abundance changes characterised by decreases in penile anaerobes [ShangRing Prevotella: -15.0%, (SD = 19.1); Mogen clamp Prevotella: -3.6% (11.2); ShangRing Veillonella: -11.3% (17.2); Mogen clamp Veillonella: -2.6% (11.8)] and increases in skin-associated facultative anaerobes [ShangRing Corynebacterium: 24.9%, (22.4); Mogen clamp Corynebacterium: 4.7% (21.3); ShangRing Staphylococcus: 21.1% (20.5); Mogen clamp Staphylococcus: 18.1% (20.1)]. Clostridium tetani was not detected during the study. INTERPRETATION: Mogen Clamp and ShangRing EIMC both changed the composition of the infant penile microbiome by reducing the proportional abundances of anaerobes and uropathogens, which is consistent with medical male circumcision findings in adults. C. tetani was not increased by either EIMC method. FUNDING: Bill and Melinda Gates Foundation.

Timing for maximum anaesthetic effect of topical cream during early infant circumcision (EIC) in Rakai, Uganda.

Objectives: The objective of this study is to determine the optimal timing for device-based infant circumcision under topical anaesthesia. Subjects/patients: We include infants aged 1-60 days who were enrolled in a field study of the no-flip ShangRing device at four hospitals in the Rakai region of south-central Uganda, between 5 February 2020 and 27 October 2020. Methods: Two hundred infants, aged 0-60 days, were enrolled, and EMLA cream was applied on the foreskin and entire penile shaft. The anaesthetic effect was assessed every 5 min by gentle application of artery forceps at the tip of the foreskin, starting at 10 min post-application until 60 min, the recommended time to start circumcision. The response was measured using the Neonatal Infant Pain Scale (NIPS). We determined the onset and duration of anaesthesia (defined as <20% of infants with NIPS score >4) and maximum anaesthesia (defined as <20% of infants with NIPS score >2). Results: Overall, NIPS scores decreased to a minimum and reversed before the recommended 60 min. Baseline response varied with age, with minimal response among infants aged 40 days. Overall, anaesthesia was achieved after at least 25 min and lasted 20-30 min. Maximum anaesthesia was achieved after at least 30 min (except among those aged >45 days where it was not achieved) and lasted up to 10 min. Conclusion: The optimal timing for maximum topical anaesthesia occurred before the recommended 60 min of waiting time. A shorter waiting time and speed may be efficient for mass device-based circumcision.

Seguridad y mayor tolerancia al esfuerzo con entrenamiento interválico en comparación con el entrenamiento de intensidad moderada continua en cardiópatas de riesgo cardiovascular muy alto / Safety and improvement in exercise tolerance with interval training vs moderate-intensity continuous training in heart disease patient of very high cardiovascular risk

Resumen Objetivo: Evaluar la seguridad y el efecto del entrenamiento por intervalos de moderada y alta intensidad (EIMI, EIAI) y compararlo con el entrenamiento de intensidad moderada continua (EIMC) en pacientes de riesgo cardiovascular (RCV) muy alto. Método: Estudio cuasi experimental de 81 pacientes que ingresaron al programas de rehabilitación cardíaca y prevención secundaria (PRHCPS); en la estratificación de riesgo, todos los pacientes presentaron ≥ 2 factores de RCV alto. Entrenamiento concurrente: aeróbico supervisado: 2 semanas de entrenamiento de base de EIMC; luego el grupo EIMC con la misma prescripción, EIMI a 3 intervalos de 3' al 70 a 80% de FCR con pausas activas de 3' al 60 a 70% de FCR; EIAI, 3 intervalos de 3' a 80 a 90% de FCR con pausas activas de 3' al 70 a 80% de FCR, entrenamiento de fuerza con tres sesiones semanales de ejercicios isotónicos y una de calistenia e intervención multidisciplinaria. Resultados: 81 pacientes asignados en tres grupos: 61 a EIMC, 13 a EIMI y 7 a EIAI, sin diferencias significativas en las variables epidemiológicas. Hubo ganancias porcentuales en MET-carga de 45%, 60% y 86% (p = 0.17) y carga-vatios de 51, 44 y 48 en EIMC, EIMI, EIAI, respectivamente (p = 0.54). A pesar de no existir diferencias estocásticamente significativas intergrupales, sí se registró una ganancia mayor en MET-carga en el grupo de EIAI. No se observó desenlace adverso en ningún tipo de entrenamiento. Conclusiones: En cardiópatas de riesgo cardiovascular muy alto, el entrenamiento interválico EIMI/EIAI supervisado es seguro, con tendencia a mayor ganancia en tolerancia al esfuerzo (MET-carga) con el EIAI en comparación con el EIMC.

Abstract Objective: Evaluate safety and effects of training at moderate and high intensity intervals (MIIT, HIIT) compared to continuous moderate intensity training (MICT) in heart disease patient with very high cardiovascular risk (CVR). Method: Quasi-experimental study of 81 patients in a cardiac rehabilitation (CR) program, after risk stratification, all patients presented at least 2 factors with high CVR. All patients were provided supervised concurrent training: aerobic: initially 2 weeks MICT. subsequently MICT group with same prescription, MIIT 3 intervals of 3 ‘to 70-80% FCR with active pause exercise of 3' to 60 a 70% FCR, HIIT 3 intervals of 3'a 80-90% FCR with active pause exercise of 3 ‘70 a 80% FCR, resistance training 3 weekly sessions isotonic exercises and 1 calisthenics and multidisciplinary intervention. Results: 81 patients assigned to: 61 MICT group, 13 MIIT and 7 HIIT, no significant differences were observed. Percentage gains were obtained in METs-load 45%, 60% and 86% (p = 0.17) and watts 51, 44 and 48 in MICT, MIIT, HIIT respectively (p = 0.54). Although there are no statistical significant intergroup differences if there is a greater improvement in MET-load in the HIIT group. There was no adverse outcome in any training. Conclusions: In very high cardiovascular risk heart disease patient, supervised interval training (MIIT/HIIT) is safe, with a tendency to greater improvement in exercise tolerance (METs-load) with HIIT compared to MICT.

Safety and improvement in exercise tolerance with interval training vs moderate-intensity continuous training in heart disease patient of very high cardiovascular risk.

OBJECTIVE: Evaluate safety and effects of training at moderate and high intensity intervals (MIIT, HIIT) compared to continuous moderate intensity training (MICT) in heart disease patient with very high cardiovascular risk (CVR). METHOD: Quasi-experimental study of 81 patients in a cardiac rehabilitation (CR) program, after risk stratification, all patients presented at least 2 factors with high CVR. All patients were provided supervised concurrent training: aerobic: initially 2 weeks MICT. subsequently MICT group with same prescription, MIIT 3 intervals of 3 'to 70-80% FCR with active pause exercise of 3' to 60 a 70% FCR, HIIT 3 intervals of 3'a 80-90% FCR with active pause exercise of 3 '70 a 80% FCR, resistance training 3 weekly sessions isotonic exercises and 1 calisthenics and multidisciplinary intervention. RESULTS: 81 patients assigned to: 61 MICT group, 13 MIIT and 7 HIIT, no significant differences were observed. Percentage gains were obtained in METs-load 45%, 60% and 86% (p = 0.17) and watts 51, 44 and 48 in MICT, MIIT, HIIT respectively (p = 0.54). Although there are no statistical significant intergroup differences if there is a greater improvement in MET-load in the HIIT group. There was no adverse outcome in any training. CONCLUSIONS: In very high cardiovascular risk heart disease patient, supervised interval training (MIIT/HIIT) is safe, with a tendency to greater improvement in exercise tolerance (METs-load) with HIIT compared to MICT.

OBJETIVO: Evaluar la seguridad y el efecto del entrenamiento por intervalos de moderada y alta intensidad (EIMI, EIAI) y compararlo con el entrenamiento de intensidad moderada continua (EIMC) en pacientes de riesgo cardiovascular (RCV) muy alto. MÉTODO: Estudio cuasi experimental de 81 pacientes que ingresaron al programas de rehabilitación cardíaca y prevención secundaria (PRHCPS); en la estratificación de riesgo, todos los pacientes presentaron ≥ 2 factores de RCV alto. Entrenamiento concurrente: aeróbico supervisado: 2 semanas de entrenamiento de base de EIMC; luego el grupo EIMC con la misma prescripción, EIMI a 3 intervalos de 3' al 70 a 80% de FCR con pausas activas de 3' al 60 a 70% de FCR; EIAI, 3 intervalos de 3' a 80 a 90% de FCR con pausas activas de 3' al 70 a 80% de FCR, entrenamiento de fuerza con tres sesiones semanales de ejercicios isotónicos y una de calistenia e intervención multidisciplinaria. RESULTADOS: 81 pacientes asignados en tres grupos: 61 a EIMC, 13 a EIMI y 7 a EIAI, sin diferencias significativas en las variables epidemiológicas. Hubo ganancias porcentuales en MET-carga de 45%, 60% y 86% (p = 0.17) y carga-vatios de 51, 44 y 48 en EIMC, EIMI, EIAI, respectivamente (p = 0.54). A pesar de no existir diferencias estocásticamente significativas intergrupales, sí se registró una ganancia mayor en MET-carga en el grupo de EIAI. No se observó desenlace adverso en ningún tipo de entrenamiento. CONCLUSIONES: En cardiópatas de riesgo cardiovascular muy alto, el entrenamiento interválico EIMI/EIAI supervisado es seguro, con tendencia a mayor ganancia en tolerancia al esfuerzo (MET-carga) con el EIAI en comparación con el EIMC.

Efficacy of knowledge and competence-based training of non-physicians in the provision of early infant male circumcision using the Mogen clamp in Rakai, Uganda.

OBJECTIVE: To assess acquisition of knowledge and competence in performing Early Infant Male Circumcision (EIMC) by non-physicians trained using a structured curriculum. SUBJECTS AND METHODS: Training in provision of EIMC using the Mogen clamp was conducted for 10 Clinical Officers (COs) and 10 Registered Nurse Midwives (RNMWs), in Rakai, Uganda. Healthy infants whose mothers consented to study participation were assigned to the trainees, each of whom performed at least 10 EIMCs. Ongoing assessment and feedback for competency were done, and safety assessed by adverse events. RESULTS: Despite similar baseline knowledge, COs acquired more didactic knowledge than RNMWs (P = 0.043). In all, 100 EIMCs were assessed for gain in competency. The greatest improvement in competency was between the first and third procedures, and all trainees achieved 80% competency and retention of skills by the seventh procedure. The median (interquartile range) time to complete a procedure was 14.5 (10-47) min for the COs, and 15 (10-50) min for the RNMWs (P = 0.180). The procedure times declined by 2.2 min for each subsequent EIMC (P = 0.005), and rates of improvement were similar for COs and RNMWs. Adverse events were comparable between providers (3.5%), of which 1% were of moderate severity. CONCLUSION: Competence-based training of non-physicians improved knowledge and competency in EIMC performed by COs and RNMWs in Uganda.