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REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system

Por: Holder-Murray · J. · Esper · S. A. · Althans · A. R. · Knight · J. · Subramaniam · K. · Derenzo · J. · Ball · R. · Beaman · S. · Luke · C. · La Colla · L. · Schott · N. · Williams · B. · Lorenzi · E. · Berry · L. R. · Viele · K. · Berry · S. · Masters · M. · Meister · K. A. · Wilkinson · T.
Introduction

Implementation of enhanced recovery pathways (ERPs) has resulted in improved patient-centred outcomes and decreased costs. However, there is a lack of high-level evidence for many ERP elements. We have designed a randomised, embedded, multifactorial, adaptive platform perioperative medicine (REMAP Periop) trial to evaluate the effectiveness of several perioperative therapies for patients undergoing complex abdominal surgery as part of an ERP. This trial will begin with two domains: postoperative nausea/vomiting (PONV) prophylaxis and regional/neuraxial analgesia. Patients enrolled in the trial will be randomised to arms within both domains, with the possibility of adding additional domains in the future.

Methods and analysis

In the PONV domain, patients are randomised to optimal versus supraoptimal prophylactic regimens. In the regional/neuraxial domain, patients are randomised to one of five different single-injection techniques/combination of techniques. The primary study endpoint is hospital-free days at 30 days, with additional domain-specific secondary endpoints of PONV incidence and postoperative opioid consumption. The efficacy of an intervention arm within a given domain will be evaluated at regular interim analyses using Bayesian statistical analysis. At the beginning of the trial, participants will have an equal probability of being allocated to any given intervention within a domain (ie, simple 1:1 randomisation), with response adaptive randomisation guiding changes to allocation ratios after interim analyses when applicable based on prespecified statistical triggers. Triggers met at interim analysis may also result in intervention dropping.

Ethics and dissemination

The core protocol and domain-specific appendices were approved by the University of Pittsburgh Institutional Review Board. A waiver of informed consent was obtained for this trial. Trial results will be announced to the public and healthcare providers once prespecified statistical triggers of interest are reached as described in the core protocol, and the most favourable interventions will then be implemented as a standardised institutional protocol.

Trial registration number

NCT04606264.

NIMBUS study protocol: a single-centre feasibility study of non-invasive monitoring with bowel ultrasound in paediatric inflammatory bowel disease

Por: Green · Z. · Mayberry · E. · Ashton · J. J. · Beattie · R. M. · Evans · A. · Wahid · A. · Edwards · M. O.
Introduction

Incidence of inflammatory bowel disease (IBD) is increasing in childhood and treatment increasingly targets mucosal healing. Monitoring bowel inflammation requires endoscopy or MRI enterography which are invasive, expensive and have long waiting lists.

We aim to examine the feasibility of a non-invasive monitoring tool—bowel ultrasound (BUS)—in children with IBD and explore correlations with inflammatory markers and disease activity measures. Some BUS criteria have been found to correlate with these markers; however, this has not been validated in children.

We aim to examine the feasibility of BUS for monitoring inflammation in this population; highlighting useful parameters for this purpose. We aim to inform a larger scale randomised controlled trial using BUS.

Methods and analysis

This prospective observational feasibility study will be carried out over 24 months at the Noah’s Ark Children’s Hospital for Wales, Cardiff; with the endpoint recruitment of 50 participants. Children aged 2–18 years with a modified Porto criteria diagnosis of IBD will be included.

Patients without IBD or who have previously undergone IBD-related surgery will be excluded; as will families unable to give informed consent.

Ultrasound scan images and reports will be collected, as well as laboratory results and clinical outcomes.

The primary aim will assess the feasibility of targeted BUS for disease monitoring; including recruitment statistics. The secondary aims will involve data collection and correlation analysis for targeted ultrasound parameters, biomarkers, disease activity scores and prediction of changes in treatment. The statistical methods will include: feasibility metrics, descriptive statistics, cross-tabulation and 2 analysis, correlation analysis, regression analysis.

Ethics and dissemination

Ethical approval is granted by NHS Research Ethics Committee. The sponsor is Cardiff and Vale University Health Board. We will publish the results in a peer-reviewed medical journal.

Trial registration number

NCT05673278.

Defining conditions for effective interdisciplinary care team communication in an open surgical intensive care unit: a qualitative study

Por: Diaz · C. M. · Egide · A. · Berry · A. · Rafferty · M. · Amro · A. · Tesorero · K. · Shapiro · M. · Ko · B. · Jones · W. · Slocum · J. D. · Johnson · J. · Stey · A. M.
Objective

Poor interdisciplinary care team communication has been associated with increased mortality. The study aimed to define conditions for effective interdisciplinary care team communication.

Design

An observational cross-sectional qualitative study.

Setting

A surgical intensive care unit in a large, urban, academic referral medical centre.

Participants

A total 6 interviews and 10 focus groups from February to June 2021 (N=33) were performed. Interdisciplinary clinicians who cared for critically ill patients were interviewed. Participants included intensivist, transplant, colorectal, vascular, surgical oncology, trauma faculty surgeons (n=10); emergency medicine, surgery, gynaecology, radiology physicians-in-training (n=6), advanced practice providers (n=5), nurses (n=7), fellows (n=1) and subspecialist clinicians such as respiratory therapists, pharmacists and dieticians (n=4). Audiorecorded content of interviews and focus groups were deidentified and transcribed verbatim. The study team iteratively generated the codebook. All transcripts were independently coded by two team members.

Primary outcome

Conditions for effective interdisciplinary care team communication.

Results

We identified five themes relating to conditions for effective interdisciplinary care team communication in our surgical intensive care unit setting: role definition, formal processes, informal communication pathways, hierarchical influences and psychological safety. Participants reported that clear role definition and standardised formal communication processes empowered clinicians to engage in discussions that mitigated hierarchy and facilitated psychological safety.

Conclusions

Standardising communication and creating defined roles in formal processes can promote effective interdisciplinary care team communication by fostering psychological safety.

Independent and joint associations of cardiorespiratory fitness and BMI with dementia risk: the Cooper Center Longitudinal Study

Por: Gafni · T. · Weinstein · G. · Leonard · D. · Barlow · C. E. · DeFina · L. F. · Pettee Gabriel · K. · Berry · J. D. · Shuval · K.
Objective

This study aimed to examine the association of midlife fitness and body mass index (BMI) with incident dementia later in life.

Design and participants

A cohort study of 6428 individuals (mean age 50.9±7.6 years) from the Cooper Center Longitudinal Study.

Measures

Cardiorespiratory fitness and BMI were assessed twice (1970–1999) during visits to the Cooper Clinic, a preventive medicine clinic in Dallas, Texas. These measures were examined as continuous and categorical variables. As continuous variables, fitness and BMI were examined at baseline (averaged of two examinations) and as absolute change between exams (mean time 2.1±1.8 years). Variables were categorised: unfit versus fit and normal versus overweight/obese. Medicare claims data were used to obtain all-cause dementia incidence (1999–2009). Mean follow-up between midlife examinations and Medicare surveillance was 15.7 ((SD=6.2) years. Multivariable models were used to assess the associations between fitness, BMI and dementia.

Results

During 40 773 person years of Medicare surveillance, 632 cases of dementia were identified. After controlling for BMI and covariates, each 1-metabolic equivalent increment in fitness was associated with 5% lower (HR 0.95; 95% CI 0.90 to 0.99) dementia risk. In comparison, after controlling for fitness and covariates, each 1 kg/m2 increment in BMI was associated with a 3.0% (HR 1.03; 95% CI 1.00 to 1.07) higher risk for dementia, yet without significance (p=0.051). Similar findings were observed when the exposures were categorised. Changes in fitness and BMI between examinations were not related to dementia. Jointly, participants who were unfit and overweight/obese had the highest (HR 2.28 95% CI 1.57 to 3.32) dementia risk compared with their fit and normal weight counterparts.

Conclusion

Lower midlife fitness is a risk marker for dementia irrespective of weight status. Being unfit coupled with overweight/obese status might increase one’s risk for dementia even further.

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