Adverse Event Reporting in Exercise Studies of Resistance Training (AERIES-RT) Recommendations and Toolkit: A modified Delphi process.

Abstract

The objective of this study was to adapt existing adverse event (AE) reporting guidelines and develop AE Reporting In Exercise Studies of Resistance Training (AERIES-RT) recommendations and toolkit. We conducted purposeful and convenience sampling to identify researchers who published resistance training (RT) trials. We invited 80 research scientists to participate in a modified Delphi consensus process. Nineteen researchers from six countries (Canada, USA, UK, Australia, Greece, and Puerto Rico) agreed to participate. We drafted adapted AE-reporting recommendations informed by interviewing participants with common health conditions who experienced AEs after RT (n=12), and researchers who published RT trials (n=14). These recommendations were turned into a survey that was distributed electronically to the Delphi participants for rating. We conducted three rounds of voting until there was consensus (criterion: minimum 74% agreement) on each recommendation. All 19 participants responded to the three survey rounds (100% response rate). After each round, the recommendations were revised based on the participants' feedback. For the first round, ten of 24 recommendations did not meet the criterion for consensus. For the second round, one of 28 recommendations did not meet the criterion for consensus. For the final round, the remaining recommendation met the criterion for consensus. The agreed upon recommendations were used to develop the AERIES-RT toolkit including a checklist, template AE reporting form, and a decision tree. Our modified e-Delphi consensus process resulted in developing the AERIES-RT toolkit that researchers can use to improve the frequency and accuracy of AE reporting in RT trials.