Adrian Gheorghe

Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial).

Objective To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery. Design Multicentre observer blinded randomised controlled trial. Participants Patients undergoing laparotomy at 21 UK hospitals. Interventions Standard care or the use of a wound edge protection device during surgery. Main outcome measures Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient’s self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device. Results 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device. Conclusions Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended. Trial registration Current Controlled Trials ISRCTN 40402832

Impact and cost-effectiveness of new tuberculosis vaccines in low- and middle-income countries

Significance To aid in prioritizing the development of tuberculosis (TB) vaccines most likely to reach the 2050 TB elimination goal, we estimated the impact and cost-effectiveness of a range of vaccine profiles in low- and middle-income countries. Using mathematical modeling, we show that vaccines targeted at adolescents/adults could have a much greater impact on the TB burden over a 2024–2050 time horizon than those vaccines targeted at infants. Such vaccines could also be cost-effective, even with relatively high vaccine prices. Our results suggest that to achieve the 2050 elimination goals, future TB vaccine development should focus on vaccines targeted at adolescents/adults, even if only relatively low efficacies and short durations of protection are technically feasible. To help reach the target of tuberculosis (TB) disease elimination by 2050, vaccine development needs to occur now. We estimated the impact and cost-effectiveness of potential TB vaccines in low- and middle-income countries using an age-structured transmission model. New vaccines were assumed to be available in 2024, to prevent active TB in all individuals, to have a 5-y to lifetime duration of protection, to have 40–80% efficacy, and to be targeted at “infants” or “adolescents/adults.” Vaccine prices were tiered by income group (US

Systematic review of the clinical effectiveness of wound-edge protection devices in reducing surgical site infection in patients undergoing open abdominal surgery

1.50–

Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers

10 per dose), and cost-effectiveness was assessed using incremental cost per disability adjusted life year (DALY) averted compared against gross national income per capita. Our results suggest that over 2024–2050, a vaccine targeted to adolescents/adults could have a greater impact than one targeted at infants. In low-income countries, a vaccine with a 10-y duration and 60% efficacy targeted at adolescents/adults could prevent 17 (95% range: 11–24) million TB cases by 2050 and could be considered cost-effective at

Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols

149 (cost saving to

HTA Implementation Roadmap in Central and Eastern European Countries

387) per DALY averted. If targeted at infants, 0.89 (0.42–1.58) million TB cases could be prevented at

Patient Reported Outcomes (PROs) in Clinical Trials: Is ‘In-Trial’ Guidance Lacking? A Systematic Review

1,692 (

Centre selection for clinical trials and the generalisability of results: a mixed methods study.

634–

The path to longer and healthier lives for all Africans by 2030: the Lancet Commission on the future of health in sub-Saharan Africa.

4,603) per DALY averted. This profile targeted at adolescents/adults could be cost-effective at

Action to address the household economic burden of non-communicable diseases

4,