Generalisability of randomised trials evaluating perioperative ß-blocker therapy in noncardiac surgery.
Br J Anaesth
; 125(6): 926-934, 2020 12.
Article
em En
| MEDLINE
| ID: mdl-32888632
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
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Ensaios Clínicos Controlados Aleatórios como Assunto
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Procedimentos Cirúrgicos Eletivos
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Seleção de Pacientes
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Antagonistas Adrenérgicos beta
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Assistência Perioperatória
Tipo de estudo:
Clinical_trials
/
Etiology_studies
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Incidence_studies
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Observational_studies
/
Risk_factors_studies
Limite:
Female
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Humans
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Male
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Middle aged
País/Região como assunto:
Europa
Idioma:
En
Revista:
Br J Anaesth
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Áustria