Validation of a free fall acrobatics intervention protocol to reduce neck loads during parachute opening shock

Abstract

BackgroundElevated 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.AimTo validate an intervention protocol to reduce POS neck loads.MethodsA protocol was developed based on observational data and theoretical calculations. Six experts rated each component of the protocol on a four-point Likert scale, regarding relevance, simplicity/feasibility and safety, and responded to open-ended questions. Two iterations were made, each followed by consensus panel protocol revisions. The content validity index (CVI) was used to quantify ratings. A measure of universal agreement (CVI/UA) was computed as the proportion of components that achieved a rating ≥3 by all raters. For safety, a high-sensitivity CVI/UA was computed with a rating of no <4 (highest score) as acceptable.ResultsCVI/UA for relevance increased from 0.80 in the first assessment to 1.00 in the second; for simplicity from 0.50 to 0.63; and for safety from 0.70 to 1.00. High-sensitivity CVI/UA for safety increased from 0.10 to 0.75. Responses to open-ended questions included safety concerns for free fall stability, altitude awareness and concerns over comprehensibility.ConclusionsThe 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.

Evaluation of content validity and feasibility of the eVISualisation of physical activity and pain (eVIS) intervention for patients with chronic pain participating in interdisciplinary pain rehabilitation programs

“…In conjunction with relevance and simplicity, commonly used for evaluation in questionnaire development, safety aspects play an important role in intervention development. From previous experiences of validating a safety-critical intervention [33] we were certain that the eVIS intervention would also benefit from systematic validation from subject expertise to identify possible overlooked risks and increase safety confidence. Contrary to many other eHealth applications, eVIS and PATRON do not include specific treatment advice or exercise modules, as this is handled within the clinical setting.…”

“…An observational design with expert assessments was used to evaluate the content validity and feasibility of eVIS as a supplement to IPRPs [29,[31][32][33]. The methodology drew on a systematic process, including iterative development and quantification of subject expert judgment as a ground for evaluation, a method previously used for validation in instrument development [31,34] but also tested for intervention protocol by our research group [33]. A consensus panel, constituted by another panel of experts, would then review and evaluate the expert judgments to identify and agree upon necessary revisions to improve the intervention protocol.…”

“…Similarly, simplicity refers to whether the intervention is easy to conduct, the clarity of instruction etc., and safety refers to whether any potential risks can be identified in using the intervention, for instance the risk of adverse events. Within the context of instrument development, the relevance and simplicity of items constitute common validity aspects for rating, but when used in the context of an intervention validation, safety is of equal significance, and has previously been used within our research group [33].…”

“…Finally, ascertaining an intervention's content validity and feasibility before proceeding to an effectiveness trial is considered as a significant strength and is highly recommended [25][26][27][28][29]33]. To date, the development, test, and evaluation stages of the intervention have taken approximately 1.5-2 years to complete.…”

Free Fall Acrobatics to Reduce Neck Loads During Parachute Opening Shock: Evaluation of an Intervention (ACROPOSE)

“…The results of the validation process in its entirety have been published. 21 Ethical considerations This study will be conducted in compliance with the Declaration of Helsinki. 22 All participants will receive oral and written information about the study, including safety aspects (eg, agreeing not to perform high-speed landings during the study), and sign a written consent to participate.…”