Prevalence and Impact of Treatment Crossover in Cardiac Surgery Randomized Trials: A Meta‐Epidemiologic Study
| Autor: | Antonino Di Franco, Giuseppe Biondi-Zoccai, Mario Gaudino, Stephen E. Fremes, Giacomo Frati, David P. Taggart, Joanna Chikwe, Marc Ruel, Leonard N. Girardi, Michele Di Mauro |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Epidemiologic study Crossover 030204 cardiovascular system & hematology law.invention surgery 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Humans Medicine Treatment effect 030212 general & internal medicine Cardiac Surgical Procedures Randomized Controlled Trials as Topic crossover meta‐epidemiologic study Cardiovascular Surgery Cross-Over Studies Systematic Review and Meta‐analysis business.industry Incidence (epidemiology) Cardiac surgery Epidemiologic Studies randomized controlled trial Cardiology and Cardiovascular Medicine business cardiac surgery |
| Zdroj: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| ISSN: | 2047-9980 |
| Popis: | Background Crossover dilutes treatment effect and reduces statistical power of intention‐to‐treat analysis. We examined incidence and impact on cardiac surgery randomized controlled trial ( RCT ) outcomes of crossover from experimental to control interventions, or vice versa. Methods and Results MEDLINE , EMBASE , and Cochrane Library were searched, and RCT s (≥100 patients) comparing ≥2 adult cardiac surgical interventions were included. Crossover from the initial treatment assignment and relative risks ( RRs ) for each trial's primary end point and mortality at longest available follow‐up were extracted. All RR s were calculated as >1 favored control group and RCT , and secondary outcome was all‐cause mortality; both were appraised as RR at the longest follow‐up available. Sixty articles reporting on 47 RCT s (25 440 patients) were identified. Median crossover rate from experimental to control group was 7.0% (first quartile, 2.0%; third quartile, 9.7%), whereas from control to experimental group, the rate was 1.3% (first quartile, 0%; third quartile, 3.6%). RR s for primary end point and mortality were higher in RCT s with higher crossover rate from experimental to control group ( RR , 1.01 [95% CI , 0.94–1.07] versus RR , 0.80 [95% CI , 0.66–0.97] and RR , 1.02 [95% CI , 0.95–1.11] versus RR , 0.94 [95% CI , 0.82–1.07], respectively). Crossover from control to experimental group did not alter effect estimates for primary end point or mortality ( RR , 0.82 [95% CI , 0.63–1.05] versus RR , 0.95 [95% CI , 0.86–1.04] and RR , 0.88 [95% CI , 0.73–1.07] versus RR , 1.02 [95% CI , 0.95–1.09], respectively). Conclusions Crossover from experimental to control group is associated with outcomes of cardiac surgery RCT s. Crossover should be minimized at designing stage and carefully appraised after study completion. |
| Databáze: | OpenAIRE |
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