Official websites use. Share sensitive information only on official, secure websites. Elevated neck pain prevalence among skydivers is associated with exposure to repeated parachute opening shock POS.
A study is planned to evaluate a preventive free fall acrobatics intervention, but prior assessment of the protocol is necessary given the complex and safety-critical study environment. A protocol was developed based on observational data and theoretical calculations. Two iterations were made, each followed by consensus panel protocol revisions. The content validity index CVI was used to quantify ratings.
Responses to open-ended questions included safety concerns for free fall stability, altitude awareness and concerns over comprehensibility. The proposed protocol has been improved in assessed relevance, simplicity and safety, and is considered validated for the start of the empirical trial. To what degree complex interventions should be preceded by open prevalidation is discussed. Expert opinion was used to systematically validate a complex and safety-critical intervention study protocol before the start of the trial.
In an iterative process, experts were invited to give quantitative scores, qualitative comments and suggestions to each discrete component of the proposed protocol, followed by consensus panel protocol revisions. As a result of this process, the proposed protocol underwent substantial changes and improved in assessed relevance, simplicity and safety.
Other complex or safety-critical intervention studies may benefit from systematic and open validation prior to the start of the trial. The processes through which interventions are developed form more or less visible cornerstones of modern healthcare. If possible side effects are unacceptable, their preclusion must take precedence to protect test subjects, who within the trial are first in line to exposure.
