Parachute use on jumping from an aircraft does not reduce death or major traumatic injuries when compared with jumping with empty backpacks, according to a new trial published in the British Medical Journal.
[perfectpullquote align=”full” bordertop=”false” cite=”” link=”” color=”” class=”” size=””]“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.”– Dr. Robert Yeh, M.D.[/perfectpullquote]
The multi-center, randomized, controlled trial screened a total of 92 aircraft passengers, out of which 23 individuals were randomized to either jump from an aircraft with a parachute (N: 12) or an empty backpack (N: 11) on their backs. The individuals were assessed after landing on the ground for the primary outcome which was a composite of death and the presence of a major traumatic injury (defined as an Injury Severity Score above 15).
The trial showed no significant difference in the primary outcome between the parachute and the empty backpack groups (0% vs 0% respectively, P>0.9). However, the authors reported significant differences between the participants and screened individuals (without enrollment) in the mean aircraft altitude (0.6 m vs 9146 m respectively, P<0.001) and the mean aircraft velocity (0 km/h vs 800 km/h, P>0.001).
Look before you leap and judge after you read
The authors of the study aimed to deliver some important messages: First, no matter how efficacious the drug or intervention is, it can be proved to be of no benefit in a certain clinical trial. Secondly, the exclusion of a certain patient population from the trial (individuals flying on high altitudes and high velocities here) can lead to misleading results. Lastly, the results of clinical trials -although important- should be assessed by the reader whether they are applicable in the real world or not.
The authors conclude, “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.”
To see the interview of Dr. Michael Gibson with Dr. Robert Yeh, Dr. Dhruv Kazi, and Dr. Duane Pinto about the PARACHUTE trial, click here.