Parachute use to prevent death and major trauma when jumping from aircraft (2018)
bmj.com
bmj.com
> The PARACHUTE trial satirically highlights some of the limitations of randomized controlled trials. Nevertheless, we believe that such trials remain the gold standard for the evaluation of most new treatments. The PARACHUTE trial does suggest, however, that their accurate interpretation requires more than a cursory reading of the abstract. Rather, interpretation requires a complete and critical appraisal of the study.
> After several rounds of discussion, the Registry declined to register the trial because they thought that “the research question lacks scientific validity” and “the trial data cannot be meaningful.” We appreciated their thorough review (and actually agree with their decision).
> All authors suffered substantial abdominal discomfort from laughter. RWY worried that BKN would not keep his mouth shut until the Christmas issue was published.
"Intervention Jumping from an aircraft (airplane or helicopter) with a parachute versus an empty backpack (unblinded)."
"Main outcome measures Composite of death or major traumatic injury (defined by an Injury Severity Score over 15) upon impact with the ground measured immediately after landing."
"Results Parachute use did not significantly reduce death or major injury (0% for parachute v 0% for control; P>0.9). This finding was consistent across multiple subgroups. Compared with individuals screened but not enrolled, participants included in the study were on aircraft at significantly lower altitude (mean of 0.6 m for participants v mean of 9146 m for non-participants; P<0.001) and lower velocity (mean of 0 km/h v mean of 800 km/h; P<0.001)."
"Conclusions: Parachute use did not reduce death or major traumatic injury when jumping from aircraft in the first randomized evaluation of this intervention. However, the trial was only able to enroll participants on small stationary aircraft on the ground, suggesting cautious extrapolation to high altitude jumps. When beliefs regarding the effectiveness of an intervention exist in the community, randomized trials might selectively enroll individuals with a lower perceived likelihood of benefit, thus diminishing the applicability of the results to clinical practice."
;-) https://www.bmj.com/content/bmj/363/bmj.k5094.full.pdf
"Participants aged 18 and over, seated on an aircraft, and deemed to be rational decision makers by the enrolling investigator were eligible. Only participants who were willing to be randomized in the study were ultimately enrolled and randomized"