Dataset Information

Generalisability of randomised trials evaluating perioperative β-blocker therapy in noncardiac surgery.

ABSTRACT:

Background

The limited applicability of evidence from RCTs in real-word practice is considered a potential bottleneck for evidence-based practice but rarely systematically assessed. Using our failure to recruit patients into a perioperative beta-blocker trial, we set out to analyse the restrictiveness and generalisability of trial eligibility criteria in a real-world cohort.

Methods

We prospectively included adult patients (≥18 yr) scheduled for elective noncardiac surgery at an academic tertiary care facility who were screened for inclusion in a planned perioperative beta-blocker RCT, which was terminated owing to recruitment failure. The primary outcome was the proportion of screened patients who matched the eligibility criteria of 36 published RCTs included in a large Cochrane meta-analysis on perioperative beta-blocker therapy. The pragmatic/explanatory level of each RCT was assessed using the PRagmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) score, which ranges from 9 points (indicating a very explanatory study) to 45 points (indicating a very pragmatic study).

Results

A total of 2241 patients (54% female, n=1215; 52 [standard deviation, 20] yr) were included for the assessment of trial eligibility between October 2015 and January 2016. Only a small proportion of patients matched the inclusion and exclusion criteria for each of the 36 RCTs, ranging from 53% to 0%. The average proportion of patients who did match the eligibility criteria of all 36 RCTs was 6.5% (n=145; 95% confidence interval, 6.3-6.6). A higher PRECIS-2 score was associated with a higher proportion of matching patients (P<0.001).

Conclusions

Trial eligibility criteria in perioperative beta-blocker therapy trials are overly restrictive and not generalisable to a real-world surgical population.

Clinical trial registration

EudraCT#: 2015-002366-23.

SUBMITTER: Titz M

PROVIDER: S-EPMC9756304 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Generalisability of randomised trials evaluating perioperative β-blocker therapy in noncardiac surgery.

Titz Markus M Schwameis Michael M Kienbacher Calvin C Buchtele Nina N Roth Dominik D Duma Andreas A Nagele Peter P Schörgenhofer Christian C Herkner Harald H

British journal of anaesthesia 20200902 6

<h4>Background</h4>The limited applicability of evidence from RCTs in real-word practice is considered a potential bottleneck for evidence-based practice but rarely systematically assessed. Using our failure to recruit patients into a perioperative beta-blocker trial, we set out to analyse the restrictiveness and generalisability of trial eligibility criteria in a real-world cohort.<h4>Methods</h4>We prospectively included adult patients (≥18 yr) scheduled for elective noncardiac surgery at an a ...[more]

PMID: 32888632

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Dataset Information

Generalisability of randomised trials evaluating perioperative β-blocker therapy in noncardiac surgery.

Background

Methods

Results

Conclusions

Clinical trial registration

Publications

Generalisability of randomised trials evaluating perioperative β-blocker therapy in noncardiac surgery.

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