Dataset Information

Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial.

ABSTRACT:

Objective

The traditional approach of null hypothesis testing dominates the design and analysis of randomised controlled trials. This study aimed to demonstrate how a simple Bayesian analysis could have been used to analyse the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome (OPTIMISE) trial to obtain more clinically interpretable results.

Design, setting, participants and interventions

The OPTIMISE trial was a pragmatic, multicentre, observer-blinded, randomised controlled trial of 734 high-risk patients undergoing major gastrointestinal surgery in 17 acute care hospitals in the UK. Patients were randomly allocated to a cardiac output-guided haemodynamic therapy algorithm for intravenous fluid and inotropic drug administration during and in the 6?hours following surgery (n=368) or to standard care (n=366). The primary outcome was a binary outcome consisting of a composite of predefined 30-day moderate or major complications and mortality.

Methods

We repeated the primary outcome analysis of the OPTIMISE trial using Bayesian statistical methods to calculate the probability that the intervention was superior, and the probability that a clinically relevant difference existed. We explored the impact of a flat prior and an evidence-based prior on our analyses.

Results

Although OPTIMISE was not powered to detect a statistically significant difference between the treatment arms for the observed effect size (relative risk=0.84, 95%?CI 0.70 to 1.01; p=0.07), by using Bayesian analyses we were able to demonstrate that there was a 96.9% (flat prior) to 99.5% (evidence-based prior) probability that the intervention was superior to the control.

Conclusions

The use of a Bayesian analytical approach provided a different interpretation of the findings of the OPTIMISE trial (compared with the original frequentist analysis), and suggested patient benefit from the intervention. Incorporation of information from previous studies provided further evidence of a benefit from the intervention. Bayesian analyses can produce results that are more easily interpretable and relevant to clinicians and policy-makers.

Trial registration number

ISRCTN04386758; Post-results.

SUBMITTER: Ryan EG

PROVIDER: S-EPMC6430028 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial.

Ryan Elizabeth G EG Harrison Ewen M EM Pearse Rupert M RM Gates Simon S

BMJ open 20190307 3

<h4>Objective</h4>The traditional approach of null hypothesis testing dominates the design and analysis of randomised controlled trials. This study aimed to demonstrate how a simple Bayesian analysis could have been used to analyse the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome (OPTIMISE) trial to obtain more clinically interpretable results.<h4>Design, setting, participants and interventions</h4>The OPTIMISE trial was a pragmatic, multicentre, observer-b ...[more]

PMID: 30850406

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Project description:BackgroundThe use of cardiac output monitoring to guide intra-venous fluid and inotropic therapies may improve peri-operative outcomes, but uncertainty exists regarding clinical effectiveness and robust cost-effectiveness evidence is lacking. The objective of the study was to evaluate the cost-effectiveness of peri-operative cardiac output-guided haemodynamic therapy versus usual care in high-risk patients undergoing major gastrointestinal surgery.MethodsThe study undertook a cost-effectiveness analysis using data from a multi-centre randomised trial that recruited patients from 17 hospitals in the United Kingdom. The trial compared cardiac output-guided, haemodynamic therapy algorithm for intra-venous fluid and inotrope (dopexamine) infusion during and 6 h following surgery, with usual care. Resource use and outcome data on 734 high-risk trial patients aged over 50 years undergoing major gastrointestinal surgery were used to report cost-effectiveness at 6 months and to project lifetime cost-effectiveness. The cost-effectiveness analysis used information on health-related quality of life (QoL) at randomisation, 30 days, and 6 months combined with information on vital status to report quality-adjusted life years (QALYs). Each QALY was valued using the National Institute for Health and Care Excellence (NICE) recommended threshold of willingness to pay (£20,000 per QALY) in conjunction with the costs of each group to report the incremental net monetary benefits (INB) of the treatment algorithm versus usual care.ResultsThe mean [SD] quality of life at 30 days and 6 months was similar between the treatment groups (at 6 months, intervention group 0.73 [0.28] versus usual care group 0.71 [0.30]; mean gain 0.03 [95 % confidence interval (CI) -0.01 to 0.08]). At 6 months, survival, mean QALYs and mean healthcare costs (intervention group £8574 versus usual care group £8974) were also similar. At the cost-effectiveness threshold of £20,000 per QALY gained, the incremental net benefit of haemodynamic therapy over the patients' lifetime was positive (£4168 [95 % CI -£3063 to £11,398]). This corresponds to an 87 % probability that this intervention is cost-effective.ConclusionsCardiac output-guided haemodynamic therapy algorithm was associated with an average cost reduction and improvement in QALY and is likely to be cost-effective. Further research is needed to confirm the clinical and cost-effectiveness of this treatment.Trial registrationISRCTN04386758.

Project description:BackgroundObesity can pose perioperative challenges related to obesity-associated co-morbidities and technical factors. However, the true impact of obesity on postoperative outcomes is not well established and reports are conflicting. The aim was to perform a systematic review and meta-analysis to explore the effect of obesity on perioperative outcomes for general surgery procedures in distinct obesity subtypes.MethodsA systematic review was performed for studies reporting postoperative outcomes in relation to BMI in upper gastrointestinal, hepatobiliary and colorectal based on an electronic search using the Cochrane Library, Science Direct, PubMed and Embase up to January 2022. The primary outcome was the incidence of 30-day postoperative mortality among patients with obesity undergoing general surgical procedures in comparison to patients with normal range BMI.ResultsSixty-two studies, including 1 886 326 patients, were eligible for inclusion. Overall, patients with obesity (including class I/II/II) had lower 30-day mortality rates in comparison to patients with a normal BMI (odds ratio (OR) 0.75, 95 per cent c.i. 0.66 to 0.86, P < 0.0001, I2 = 71 per cent); this was also observed specifically in emergency general surgery (OR 0.83, 95 per cent c.i. 0.79 to 0.87, P < 0.0000001, I2 = 7 per cent). Compared with normal BMI, obesity was positively associated with an increased risk of 30-day postoperative morbidity (OR 1.11, 95 per cent c.i. 1.04 to 1.19, P = 0.002, I2 = 85 per cent). However, there was no significant difference in postoperative morbidity rates between the cohorts of patients with a normal BMI and class I/II obesity (OR 0.98, 95 per cent c.i. 0.92 to 1.04, P = 0.542, I2 = 92 per cent). Overall, the cohort with obesity had a higher rate of postoperative wound infections compared with the non-obese group (OR 1.40, 95 per cent c.i. 1.24 to 1.59, P < 0.0001, I2 = 82 per cent).ConclusionThese data suggest a possible 'obesity paradox' and challenge the assumption that patients with obesity have higher postoperative mortality compared with patients with normal range BMI. Increased BMI alone is not associated with increased perioperative mortality in general surgery, highlighting the importance of more accurate body composition assessment, such as computed tomography anthropometrics, to support perioperative risk stratification and decision-making.Registration numberCRD42022337442 (PROSPERO https://www.crd.york.ac.uk/prospero/).

Project description:Importance:Major adverse cardiovascular and cerebrovascular events (MACCE) are a significant source of perioperative morbidity and mortality following noncardiac surgery. Objective:To evaluate national trends in perioperative cardiovascular outcomes and mortality after major noncardiac surgery and to identify surgical subtypes associated with cardiovascular events using a large administrative database of United States hospital admissions. Design, Setting, Participants:Patients who underwent major noncardiac surgery from January 2004 to December 2013 were identified using the National Inpatient Sample. Main Outcomes and Measures:Perioperative MACCE (primary outcome), defined as in-hospital, all-cause death, acute myocardial infarction (AMI), or acute ischemic stroke, were evaluated over time. Results:Among 10?581?621 hospitalizations (mean [SD] patient age, 65.74 [12.32] years; 5?975?798 female patients 56.60%]) for major noncardiac surgery, perioperative MACCE occurred in 317?479 hospitalizations (3.0%), corresponding to an annual incidence of approximately 150?000 events after applying sample weights. Major adverse cardiovascular and cerebrovascular events occurred most frequently in patients undergoing vascular (7.7%), thoracic (6.5%), and transplant surgery (6.3%). Between 2004 and 2013, the frequency of MACCE declined from 3.1% to 2.6% (P for trend <.001; adjusted odds ratio [aOR], 0.95; 95% CI, 0.94-0.97) driven by a decline in frequency of perioperative death (aOR, 0.79; 95% CI, 0.77-0.81) and AMI (aOR, 0.87; 95% CI, 0.84-0.89) but an increase in perioperative ischemic stroke from 0.52% in 2004 to 0.77% in 2013 (P for trend <.001; aOR 1.79; CI 1.73-1.86). Conclusions and Relevance:Perioperative MACCE occurs in 1 of every 33 hospitalizations for noncardiac surgery. Despite reductions in the rate of death and AMI among patients undergoing major noncardiac surgery in the United States, perioperative ischemic stroke increased over time. Additional efforts are necessary to improve cardiovascular care in the perioperative period of patients undergoing noncardiac surgery.

Dataset Information

Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial.

Objective

Design, setting, participants and interventions

Methods

Results

Conclusions

Trial registration number

Publications

Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial.

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