The usefulness of randomized trials of lifestyle interventions for overweight, obesity, or metabolic syndrome: A systematic review.

BACKGROUND: Randomized controlled trials (RCTs) widely considered the gold standard for evidence-based healthcare may be limited in their clinical usefulness in lifestyle interventions for adults with overweight, obesity, or metabolic syndrome. OBJECTIVE: In this systematic review of lifestyle intervention RCTs we delineated trial usefulness. METHODS: Following prospective registration in PROSPERO (CRD4202347896), we conducted a comprehensive search across Medline, Scopus, Web of Science, and the Cochrane Library databases, covering the period from inception to December 2023. RCTs involving dietary interventions, with or without physical activity, and with or without behavioural support were included. Two reviewers independently performed study selection and data extraction. Study usefulness was assessed using a multidimensional 14 item questionnaire. Percentage compliance with usefulness items was computed. RESULTS: Of 1175 records, 30 RCTs (12,841 participants) were included. Among these, 13 (43%) RCTs complied with half of the usefulness items and only 3 (10%) complied with two-thirds of the items. For each usefulness item individually: 30 (100%) reported the burden of the problem addressed, 15 (50%) contextualized the trial through a systematic review, 18 (60%) presented an informative trial with clinically meaningful outcomes evaluated at a stated statistical power, 17 (57%) had low risk of bias, 2 (7%) exhibited pragmatic features pertaining to the trial methodologies and outcomes relevant to real-world application.18 (60%) were patient centred with formal patient involvement, none (0%) demonstrated value for money, 17 (57%) were completed according to their feasibility assessment achieving at least 90% of the estimated sample size, and 30 (100%) reported at least one of five transparency or openness features. CONCLUSION: Only one in 10 lifestyle RCTs met two-thirds of the usefulness features. It is imperative to meet these criteria when devising future trials within the field of nutrition to reduce research waste.

National Survey and consensus document on dosing strategies for beta-lactam antibiotics against multidrug-resistant gram-negative bacilli (MDR-GNB) in critically ill patients undergoing extracorporeal life support techniques: The DOSEBL study protocol. / Encuesta nacional y elaboración de un documento de consenso sobre estrategias de dosificación de antibióticos beta-lactámicos frente a bacterias gramnegativas multirresistentes (BGN-MDR) en pacientes críticos que son tratados con técnicas de soporte vital extracorpóreas: protocolo de estudio DOSEBL.

INTRODUCTION: Infections caused by multidrug-resistant gram-negative bacilli (MDR-GNB) in critically ill patients present a challenge for timely and appropriate antibiotic treatment. This is particularly important in patients undergoing extracorporeal life support techniques such as renal replacement therapy and extracorporeal membrane oxygenation. These techniques can introduce additional pharmacokinetic alterations, potentially leading to suboptimal exposure to antibiotics. This study aims to outline dosing strategies and therapeutic drug monitoring protocols for new ß-lactam antibiotics effective against MDR-GNB in critically ill patients undergoing extracorporeal life support techniques at a national level. Additionally, the study seeks to develop a consensus document, based on available evidence. METHODS: The project will comprise two main phases: I) A national survey, and II) the development of a consensus document. This consensus document, undertaken according to ACCORD guidelines, will encompass: a) establishment of a multidisciplinary panel of experts, b) prospective registration of the consensus, c) evidence synthesis, d) modified Delphi rounds. The antimicrobials to be included will be: meropenem, ceftazidime/avibactam, ceftolozane/tazobactam, cefiderocol, meropenem/vaborbactam, imipenem/relebactam, and aztreonam. Extracorporeal life support techniques will include continuous renal replacement therapy, conventional intermittent hemodialysis, and extracorporeal membrane oxygenation. DISCUSSION: The availability of extracorporeal life support techniques has expanded significantly in recent years, alongside a rise in the prevalence of infections caused by multidrug-resistant gram-negative bacilli (MDR-GNB). There is a need to develop evidence-based tools of high quality to standardize dosing and monitoring strategies for new ß-lactam antibiotics.