Use of real-world registry data: a hernia mesh example.

PURPOSE: Clinical performance of hernia mesh devices is poorly understood due to a lack of relevant clinical trial and real-world data (RWD). Registries offer a means to capture longitudinal data in real-world practice. This report highlights the need for data quality, completeness, and appropriate analysis methodology for more accurate and informed interpretation of RWE of medical devices. METHODS: Hernia mesh registry data were used to cross-tabulate the 30-day infection rate of patients who received one of four mesh types. RESULTS: Initial data review suggested lower infection rate for permanent mesh versus absorbable mesh. Additional registry RWD were factored into the analysis, providing more context in the interpretation of the results. CONCLUSIONS: High-quality registries can be used to generate real-world evidence (RWE) to support surveillance and other regulatory decisions.

Understanding the patient perspective after ventral hernia repair.

PURPOSE: More than 350,000 ventral hernia repairs are performed in the U.S. each year. However, long-term quality of life of patients living with hernia repair is less known. Follow-up using patient-reported outcomes (measures) is an important representation of the patient experience and can inform quality improvements of hernia treatments. This study aims to understand the patients' experience after ventral hernia repair, to enhance quality of care and long-term hernia treatment outcomes. METHODS: To better understand long-term outcomes of ventral hernia repair and to enhance an existing PRO tool, two rounds of semi-structured interviews and focus groups were conducted. In total, 22 patients who had ventral hernia repair were enrolled. The patient perspectives obtained were grouped into themes to inform the further development of the PRO tool. Data were transcribed and analyzed using atlas.ti and Microsoft Word. RESULTS: Ten major themes were identified in this analysis. Patients' quality of life was impacted by hernia repairs and hernia recurrences, including chronic pain, effects on daily activities and social relationships, and the challenge in finding new treatments. The lack of provider-patient communication and patient understanding of hernia repairs highlighted the need for providing patients with more comprehensive information regarding repair options and outcomes prior to surgery. CONCLUSION: PRO assessments and meaningful communications between the physician and the patient can provide a comprehensive benefit-risk assessment prior to surgery, and may also improve patient understanding of what to expect during recovery from surgery.

Comparison of caudal epidural bupivacaine with bupivacaine plus tramadol and bupivacaine plus ketamine for postoperative analgesia in children.

This study compared the effect of single-dose caudal epidural bupivacaine, bupivacaine plus ketamine and bupivacaine plus tramadol for postoperative pain management in children having surgery for inguinal hernia. Following ethics committee approval and informed parental consent, 75 children ASA PS I and II, between three and nine years of age and scheduled for elective unilateral inguinal hernia repair with general anaesthesia were recruited. The patients were randomly divided into three groups to receive 0.5 ml/kg caudal bupivacaine 0.25% (group B), bupivacaine 0.25% plus tramadol 1 mg/kg (group BT) or bupivacaine 0.25% plus ketamine 0.5 mg/kg (group BK). The injections were performed under general anaesthesia. Mean arterial pressure, heart rate, pulse oximetry, respiratory rate and sedation and pain scores were recorded at defined intervals following recovery from anaesthesia. The groups were similar in age, weight and duration of operation (P >0.05). No patient experienced hypotension, bradycardia or respiratory depression. Duration of analgesia was (mean+/-SD) 6.5+/-4.1 h in group B, 9.2+/-3.9 h in group BK, and 8.5+/-3.1 h in group BT (P <0.05). More patients in group B required supplementary analgesics in the first 24 h (P <0.05). Sedation scores were comparable in all groups. Incidence of emesis and pruritus was similar in all the groups. Caudally administered 0.5 ml/kg bupivacaine 0.25% plus ketamine or bupivacaine 0.25% plus tramadol 1 mg/kg provided significantly longer duration of analgesia without an increase in the adverse effects when compared to bupivacaine alone.

Occurrence, significance & molecular epidemiology of cholera outbreaks in West Bengal.

BACKGROUND & OBJECTIVE: Diarrhoeal disease outbreaks are causes of major public health emergencies in India. We carried out investigation of two cholera outbreaks, for identification, antimicrobial susceptibility testing, phage typing and molecular characterization of isolated Vibrio cholerae O1, and to suggest prevention and control measures. METHODS: A total of 22 rectal swabs and 20 stool samples were collected from the two outbreak sites. The V. cholerae isolates were serotyped and antimicrobial susceptibility determined. Pulsed- field gel electrophoresis (PFGE) was performed to identify the clonality of the V. cholerae strains which elucidated better understanding of the epidemiology of the cholera outbreaks. RESULTS: Both the outbreaks were caused by V. cholerae O1 (one was caused by serotype Ogawa and the other by serotype Inaba). Clinically the cases presented with profuse watery diarrhoea and dehydration. All the tested V. cholerae isolates were sensitive to tetracycline, gentamycin and azithromycin but resistance for ampicillin, co-trimoxazole, nalidixic acid, and furazolidone. PFGE pattern of the isolates from the two outbreaks revealed that they were clonal in origin. Stoppage of the source of water contamination and chlorination of drinking water resulted in terminating the two outbreaks. INTERPRETATION & CONCLUSION: The two diarrhoeal outbreaks were caused by V. cholerae O1 (Inaba/Ogawa). Such outbreaks are frequently seen in cholera endemic areas in many parts of the world. Vaccination is an attractive disease (cholera) prevention strategy although long-term measures like improvement of sanitation and personal hygiene, and provision of safe water supply are important, but require time and are expensive.