Interventional studies are empirical for evidence based practice. The assessment of a new drug, surgery, or any other intervention should be evaluated through multiple phases of clinical trials before introduction into clinical practice. In addition, randomized controlled trials are considered the gold-standard studies to test a causative relationship and precisely evaluate the safety and efficacy of an intervention.
The planning, conducting, and reporting interventional studies should be standardized to enhance transparency, improve quality, and minimize bias as possible. In this regard, EQUATOR network has developed the SPIRIT statement for reporting protocols of clinical trials. The SPIRIT checklist recommends full description of all planned processes in the clinical trial. We encourage adherence to SPIRIT statement for reporting protocols of clinical trials.
(1) SPIRIT statement: http://www.ncbi.nlm.nih.gov/pubmed/23295957
(2) SPIRIT statement explanation and elaboration: http://www.ncbi.nlm.nih.gov/pubmed/23303884
(3) EQUATOR Network: http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/