Study design: This is a Delphi study.
Objectives: Defining variables that potentially influence the outcomes of an animal study regarding pathophysiology of traumatic spinal cord injury (TSCI).
Setting: This study was conducted in Iran.
Methods: A modified two-round Delphi study was conducted. As the first round, an initial questionnaire was developed on the basis of literature and a series of focus group discussions. In the second round, the participants were asked to score the items through a 10-point scale. Consensus was achieved through the following criteria: (1) the median of scores has to be at 7.5 or higher, and (2) at least 70% of participants need to rate 7 or higher. Also, the inter-rater reliability analysis was performed to determine consistency among raters using the Kappa coefficient and Cronbach's alpha.
Results: Twenty-one experts participated in our study. From the first round of the study, a 47-item checklist was developed. By considering the aforementioned criteria for consensus building on extremely important factors, we reached a 15-item checklist including species, strain, method and level of injury, control group, genetic background, severity of injury, attrition, use of appropriate test, blindness, method of allocation to treatments, regulation and ethics, age/weight, bladder expression, number of animals/group and statistics. The inter-rater reliability for the raters was found to be Kappa=0.82 (P<0.001). A Cronbach's alpha of 0.9 for all the questions indicated high internal consistency.
Conclusion: This study introduces a checklist of variables that potentially influence the outcomes of animal studies regarding TSCI pathophysiology and describe its validity and reliability.