How completely are randomized controlled trials of non-pharmacological interventions following concussion reported? A systematic review.

To examine the reporting completeness of randomized controlled trials (RCTs) of non-pharmacological interventions following concussion. We searched MEDLINE, Embase, PsycInfo, CINAHL, and Web of Science up to May 2022. Two reviewers independently screened studies and assessed reporting completeness using the Template for Intervention Description and Replication (TIDieR), Consensus on Exercise Reporting Template (CERT), and international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) checklists. Additional information was sought my study authors where reporting was incomplete. Risk of bias (ROB) was assessed with the Cochrane ROB-2 Tool. RCTs examining non-pharmacological interventions following concussion. We included 89 RCTs (n = 53 high ROB) examining 11 different interventions for concussion: sub-symptom threshold aerobic exercise, cervicovestibular therapy, physical/cognitive rest, vision therapy, education, psychotherapy, hyperbaric oxygen therapy, transcranial magnetic stimulation, blue light therapy, osteopathic manipulation, and head/neck cooling. Median scores were: TIDieR 9/12 (75%; interquartile range (IQR) = 5; range: 5-12), CERT 17/19 (89%; IQR = 2; range: 10-19), and i-CONTENT 6/7 (86%; IQR = 1; range: 5-7). Percentage of studies completely reporting all items was TIDieR 35% (31/89), CERT 24% (5/21), and i-CONTENT 10% (2/21). Studies were more completely reported after publication of TIDieR (t RCTs of non-pharmacological interventions following concussion demonstrate moderate to good reporting completeness, but are often missing key components, particularly modifications, motivational strategies, and qualified supervisor. Reporting completeness improved after TIDieR and CERT publication, but publication in highly cited journals and low ROB do not guarantee reporting completeness.

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Competing interests JJvI reported being the founder of R2P Concussion Management. RM reported receiving research funds from grants from the National Institutes of Health, the Department of Defense, the National Football League and Abbott Laboratories. KOY reported receiving grant funding from the Canadian Institutes of Health Research (CIHR), book royalties (Guilford Press and Cambridge University Press), and editorial stipend from American Psychological Association, as well as funding through the Ronald and Irene Ward Chair in Pediatric Brain Injury funded by the Alberta Children's Hospital Foundation. RZ reported receiving competitively-funded research grants from CIHR, Ontario Neurotrauma Foundation, Physician Services Incorporated Foundation, Children's Hospital of Eastern Ontario Foundation, Ontario Brain Institute, and Ontario SPOR Support Unit, and the National Football League Scientific Advisory Board. He holds a Clinical Research Chair in Pediatric Concussion from University of Ottawa, and is on the concussion advisory board for Parachute Canada (a non-profit injury prevention charity), and is the co-founder, Scientific Director and a minority shareholder in 360 Concussion Care. All authors have read and approved the final version of the manuscript, and agree with the order of presentation of the authors.