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Elicitation of prior probability distributions for a proposed Bayesian randomized clinical trial of whole blood for trauma resuscitation.

ABSTRACT: BACKGROUND:Whole blood trauma resuscitation is conceptually appealing and increasingly used but lacks evidence. A randomized controlled trial is needed but challenging to design. A Bayesian approach might be more efficient and more interpretable than a conventional frequentist design. We report the results on an elicitation meeting to create prior probability distributions to help develop such a trial. METHODS:In-person expert elicitation meeting, based on Sheffield Elicitation Framework methodology. We used an interactive graphical tool to elicit the quantities of interest (24-hour mortality and certainty required). Two rounds were conducted, with an intervening discussion of deidentified responses. Individual responses were aggregated into probability distributions. RESULTS:Fifteen experts participated. The pooled belief was that the median 24-hour mortality of trauma patients with hemorrhagic shock treated with component therapy (the current standard of care) was 19% (95% credible interval [CrI], 6%-45%), and the median 24-hour mortality of those treated with whole blood, 16% (95% CrI, 5%-39%). The pooled prior distribution for the relative risk had a median of 0.84 (95% CrI, 0.26-3.1), indicating that the expert group had a 64% prior belief that whole blood decreases 24-hour mortality compared to component therapy. CONCLUSIONS:Experts had moderately strong beliefs that whole blood reduces the 24-hour mortality of trauma patients with hemorrhagic shock. These data will assist with the design and planning of a Bayesian trial of whole blood resuscitation, which will help to answer a key question in contemporary transfusion practice.

SUBMITTER: Jansen JO

PROVIDER: S-EPMC7079110 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Elicitation of prior probability distributions for a proposed Bayesian randomized clinical trial of whole blood for trauma resuscitation.

Jansen Jan O JO Wang Henry H Holcomb John B JB Harvin John A JA Richman Joshua J Avritscher Elenir E Stephens Shannon W SW Truong Van Thi Thanh VTT Marques Marisa B MB DeSantis Stacia M SM Yamal Jose-Miguel JM Pedroza Claudia C

Transfusion 20200122 3

<h4>Background</h4>Whole blood trauma resuscitation is conceptually appealing and increasingly used but lacks evidence. A randomized controlled trial is needed but challenging to design. A Bayesian approach might be more efficient and more interpretable than a conventional frequentist design. We report the results on an elicitation meeting to create prior probability distributions to help develop such a trial.<h4>Methods</h4>In-person expert elicitation meeting, based on Sheffield Elicitation Fr ...[more]

PMID: 31970796

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Project description:BackgroundBayesian methods are increasing in popularity in clinical research. The design of Bayesian clinical trials requires a prior distribution, which can be elicited from experts. In diseases with international differences in management, the elicitation exercise should recruit internationally, making a face-to-face elicitation session expensive and more logistically challenging. Thus, we used a remote, real-time elicitation exercise to construct prior distributions. These elicited distributions were then used to determine the sample size of the Bronchiolitis in Infants with Placebo Versus Epinephrine and Dexamethasone (BIPED) study, an international randomised controlled trial in the Pediatric Emergency Research Network (PERN). The BIPED study aims to determine whether the combination of epinephrine and dexamethasone, compared to placebo, is effective in reducing hospital admission for infants presenting with bronchiolitis to the emergency department.MethodsWe developed a Web-based tool to support the elicitation of the probability of hospitalisation for infants with bronchiolitis. Experts participated in online workshops to specify their individual prior distributions, which were aggregated using the equal-weighted linear pooling method. Experts were then invited to provide their comments on the aggregated distribution. The average length criterion determined the BIPED sample size.ResultsFifteen paediatric emergency medicine clinicians from Canada, the USA, Australia and New Zealand participated in three workshops to provide their elicited prior distributions. The mean elicited probability of admission for infants with bronchiolitis was slightly lower for those receiving epinephrine and dexamethasone compared to supportive care in the aggregate distribution. There were substantial differences in the individual beliefs but limited differences between North America and Australasia. From this aggregate distribution, a sample size of 410 patients per arm results in an average 95% credible interval length of less than 9% and a relative predictive power of 90%.ConclusionRemote, real-time expert elicitation is a feasible, useful and practical tool to determine a prior distribution for international randomised controlled trials. Bayesian methods can then determine the trial sample size using these elicited prior distributions. The ease and low cost of remote expert elicitation mean that this approach is suitable for future international randomised controlled trials.Trial registrationClinicalTrials.gov NCT03567473.

Project description:ObjectiveTo propose postpartum recovery domains.DesignConcept elicitation study.SettingSemi-structured interviews.PopulationTen writing committee members and 50 stakeholder interviews (23 postpartum women, nine general obstetricians, five maternal and fetal medicine specialists, eight nurses and five obstetric anaesthetists).MethodsAlternating interviews and focus group meetings until concept saturation was achieved (no new themes discussed in three consecutive interviews). Interviews were digitally recorded and transcribed, and an iterative coding process was used to identify domains.Main outcome measuresThe primary outcome was to identify recovery domains. We also report key symptoms and concerns. Discussion frequency and importance scores (0-100; 0 = not important; 100 = vitally important to recovery) were used to rank domains. Discussion frequency was used to rank factors helping and hindering recovery, and to determine the greatest challenges experienced postpartum.ResultsThirty-four interviews and two focus group meetings were performed. The 13 postpartum recovery domains identified, (ranked highest to lowest) were: psychosocial distress, surgical/medical factors, infant feeding and breast health, psychosocial support, pain, physical function, sleep, motherhood experience, infant health, fatigue, appearance, sexual function and cognition. The most frequently discussed factors facilitating postpartum recovery were: family support, lactation/breastfeeding support and partner support. The most frequently discussed factor hindering recovery was inadequate social support. The most frequent challenges reported were: breastfeeding (week 1), breastfeeding (week 3) and sleep (week 6).ConclusionsWe propose 13 domains that comprehensively describe recovery in women delivering in a single centre within the USA. This provides a novel framework to study the postpartum recovery process.Tweetable abstractWe propose 13 postpartum recovery domains that provide a framework to study the recovery process following childbirth.

Project description:BackgroundInformation on hyperoxemia among patients with trauma has been limited, other than traumatic brain injuries. This study aimed to elucidate whether hyperoxemia during resuscitation of patients with trauma was associated with unfavorable outcomes.MethodsA post hoc analysis of a prospective observational study was carried out at 39 tertiary hospitals in 2016-2018 in adult patients with trauma and injury severity score (ISS) of > 15. Hyperoxemia during resuscitation was defined as PaO2 of ≥ 300 mmHg on hospital arrival and/or 3 h after arrival. Intensive care unit (ICU)-free days were compared between patients with and without hyperoxemia. An inverse probability of treatment weighting (IPW) analysis was conducted to adjust patient characteristics including age, injury mechanism, comorbidities, vital signs on presentation, chest injury severity, and ISS. Analyses were stratified with intubation status at the emergency department (ED). The association between biomarkers and ICU length of stay were then analyzed with multivariate models.ResultsAmong 295 severely injured trauma patients registered, 240 were eligible for analysis. Patients in the hyperoxemia group (n = 58) had shorter ICU-free days than those in the non-hyperoxemia group [17 (10-21) vs 23 (16-26), p < 0.001]. IPW analysis revealed the association between hyperoxemia and prolonged ICU stay among patients not intubated at the ED [ICU-free days = 16 (12-22) vs 23 (19-26), p = 0.004], but not among those intubated at the ED [18 (9-20) vs 15 (8-23), p = 0.777]. In the hyperoxemia group, high inflammatory markers such as soluble RAGE and HMGB-1, as well as low lung-protective proteins such as surfactant protein D and Clara cell secretory protein, were associated with prolonged ICU stay.ConclusionsHyperoxemia until 3 h after hospital arrival was associated with prolonged ICU stay among severely injured trauma patients not intubated at the ED.Trial registrationUMIN-CTR, UMIN000019588 . Registered on November 15, 2015.

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Elicitation of prior probability distributions for a proposed Bayesian randomized clinical trial of whole blood for trauma resuscitation.

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Elicitation of prior probability distributions for a proposed Bayesian randomized clinical trial of whole blood for trauma resuscitation.

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