Dataset Information

The perceived benefit of intraoperative stress modifiers for surgeons: an experimental simulation study in volunteers.

ABSTRACT:

Background

During surgery, surgeons often work under stressful conditions, which could affect patient safety. Reducing intraoperative stress for surgeons could benefit surgeons and subsequently patients. It is difficult to study stress and stress relief in real life situations due to the multitude of confounding factors. The aim of this study was to evaluate simulated intraoperative stressors on surgeons' stress levels and the effect of an intervention (pause including a sugar-containing drink) during standardized experiments (simulated operations).

Methods

An experimental interventional study was conducted using a simulator. The healthy surgeon volunteers were randomized to intervention and control in a cross-over design. Primary endpoint was salivary cortisol difference between a pause including a sugar containing drink (intervention) and controls. Secondary endpoints were change in heart rate, change in self-perceived stress measured by the State Trait Anxiety Inventory (STAI), and experience of the intraoperative pause. Endpoints were calculated with a mixed effect analysis of covariance (ANCOVA) model.

Results

Seventeen surgeons performed 32 experiments. There was no statistically significant difference in salivary cortisol between simulations with and without a pause including a sugar-containing drink; percent reduction, 8% (0.92 (95%CI:0.72;1.18)), p-value = 0.469. The surgeons' self-estimation of intervention was positive, but there was no statistically significant difference in heart rate or STAI.

Conclusions

The surgeons' experience of a pause including a drink was positive but there were no differences in physiological outcomes of the intervention. Lessons learned from this study could contribute to optimizing design of future studies.

Trial registration

Clinicaltrials.gov NCT04626648 , Registered November 6, 2020, retrospectively registered.

SUBMITTER: Erestam S

PROVIDER: S-EPMC8164765 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Publications

The perceived benefit of intraoperative stress modifiers for surgeons: an experimental simulation study in volunteers.

Erestam Sofia S Bock David D Andersson Annette Erichsen AE Haglind Eva E Park Jennifer J Angenete Eva E

Patient safety in surgery 20210529 1

<h4>Background</h4>During surgery, surgeons often work under stressful conditions, which could affect patient safety. Reducing intraoperative stress for surgeons could benefit surgeons and subsequently patients. It is difficult to study stress and stress relief in real life situations due to the multitude of confounding factors. The aim of this study was to evaluate simulated intraoperative stressors on surgeons' stress levels and the effect of an intervention (pause including a sugar-containing ...[more]

PMID: 34051829

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Project description:BackgroundStopping trials early because of a favourable interim analysis can exaggerate benefit. This study simulated trials typical of those stopping early for benefit in the real world and estimated the degree to which early stopping likely overestimates benefit.MethodsFrom 1 million simulated trials, we selected those trials that exceeded interim stopping criteria, and compared apparent benefit when stopped with the true benefit used to generate the data. Each simulation randomly assigned period of observation, number of subjects, and control event rate using normal distributions centred on the same parameters in a template trial typical of real-world "truncated" (i.e. stopped for benefit) trials. The intervention's true relative risk reduction (RRR) was also randomized, and assumed 1% of drugs have a warfarin-like effect (60% RRR), 5% a statin-like effect (35% RRR), 39% an ASA-like effect (15% RRR), 50% no effect (0% RRR), and that 5% would cause harm (modelled as a 20% relative risk increase). Trials had a single interim analysis and a z-value for stopping of 2.782 (O'Brien-Fleming threshold). We also modelled (1) a large truncated trial based on the SPRINT blood pressure trial (using SPRINT's parameters and stopping criteria) and (2) the same typical truncated trials if they instead went to completion as planned with no interim analysis.ResultsFor typical truncated trials, the true RRR was roughly 2/3 the observed RRR at the time of stopping. RRR was overestimated by an absolute 14.9% (median, IQR 6.4-24.6) in typical truncated trials, by 5.3% (IQR -0.1 to 11.4) in the same trials if instead carried to completion, and by 2.3% (IQR 0.98-1.09) in large SPRINT-like trials. For all models, to keep the absolute RRR overestimate below 5%, 250 events were required.ConclusionSimulated trials typical of those stopping early for benefit overestimate the true relative risk reduction by roughly 50% (i.e. the true RRR was 2/3 of the observed value). Overestimation was much smaller, and likely unimportant, when simulating large SPRINT-like trials stopping early. Whether trials were large or small, stopped early or not, a minimum 250 events were needed to avoid overestimating relative risk reduction by an absolute 5% or more.

Dataset Information

The perceived benefit of intraoperative stress modifiers for surgeons: an experimental simulation study in volunteers.

Background

Methods

Results

Conclusions

Trial registration

Publications

The perceived benefit of intraoperative stress modifiers for surgeons: an experimental simulation study in volunteers.

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