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

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.

Detecting cam-type deformities on plain radiographs: what is the optimal lateral view?

PURPOSE: Radial magnetic resonance imaging (MRI) is the most accurate diagnostic tool in assessing cam-type femoroacetabular impingement. Plain radiographs, however, are useful for the initial diagnosis in the daily practice and there is still debate regarding the optimal lateral view. The purpose of this study was to investigate the reliability of detecting cam deformities using the frog-leg view or the 45° Dunn view by comparison with radial MRI. MATERIAL: 66 consecutive hips with plain radiographs (36 with AP and frog-leg views, 30 with AP and 45° Dunn views) and radial MRI were assessed. Alpha angle measurements were obtained both for radiographs and for radial MRI reformats by two investigators. Statistics included frequency analysis, bivariate linear correlation analyses, and cross-table analyses testing the sensitivity and specificity of the radiographic projections for detecting an alpha angle larger than 55°. RESULTS: The intra-class correlation revealed excellent agreement between the two raters [ICC = 0.959, CI (0.943; 0.972)]. 50% (33/66) had the maximum alpha angle in the superior-anterior aspect of the femoral head-neck junction. Cam deformity was found in 40/66 cases (61%) in radial MRI. Pearson correlation demonstrated that the 45° Dunn view was most accurate for the superior-anterior aspect (0.730, p < 0.05). The frog-leg view was best suited for the anterior aspect (0.703, p < 0.05). The sensitivity for detecting cam deformities in the 45° Dunn view was 84 vs 62% in the frog-leg view. CONCLUSION: The frog-leg lateral radiograph does not provide reliable measurements of the alpha angle. This study highlights the importance of the 45° Dunn view for early detection of femoroacetabular cam-type impingement.