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

Jacqueline Josee van Ierssel; Olivia Galea; Kirsten Holte; Caroline Luszawski; Elizabeth Jenkins; Jennifer O'Neil; Carolyn A Emery; Rebekah Mannix; Kathryn Schneider; Keith Owen Yeates; Roger Zemek

doi:10.1016/j.jshs.2023.08.003

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

J Sport Health Sci. 2023 Aug 22:S2095-2546(23)00076-5. doi: 10.1016/j.jshs.2023.08.003. Online ahead of print.

Affiliations

¹ Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8L1, Canada. Electronic address: jminn044@uottawa.ca.
² The Centre for Health, Activity and Rehabilitation Research, University of Otago, Dunedin 9016, New Zealand.
³ Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada; Alberta Children's Hospital Research Institute; University of Calgary, Calgary, AB T2N 1N4, Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB T2N 4N1, Canada.
⁴ Alberta Children's Hospital Research Institute; University of Calgary, Calgary, AB T2N 1N4, Canada; Department of Psychology, University of Calgary, Calgary, AB T2N 1N4, Canada.
⁵ Faculty of Medicine, University of Ottawa, Ottawa, ON K1H 8M5, Canada.
⁶ School of Rehabilitation Sciences, University of Ottawa, Ottawa, ON K1H 8M5, Canada; Bruyère Research Institute, Ottawa, ON K1N 5C8, Canada.
⁷ Departments of Pediatrics and Emergency Medicine, Harvard Medical School, Boston, MA 02115, USA.
⁸ Department of Psychology, University of Calgary, Calgary, AB T2N 1N4, Canada; Alberta Children's Hospital Research Institute; University of Calgary, Calgary, AB T2N 1N4, Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB T2N 4N1, Canada.
⁹ Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8L1, Canada; Departments of Pediatrics and Emergency Medicine, University of Ottawa, Ottawa, ON K1H 8M5, Canada.

PMID: 37619783
DOI: 10.1016/j.jshs.2023.08.003

Abstract

Purpose: To examine the reporting completeness of randomized controlled trials (RCTs) of non-pharmacological interventions following concussion.

Methods: 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.

Results: 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 (t₈₇ = 2.08; p = 0.04) and CERT (t₁₉ = 2.72; p = 0.01). Reporting completeness was not strongly associated with journal impact factor (TIDieR: r_s = 0.27; p = 0.01; CERT: r_s = -0.44; p = 0.06; i-CONTENT: r_s = -0.17; p = 0.48) or ROB (TIDieR: r_s = 0.11; p = 0.31; CERT: r_s = 0.04; p = 0.86; i-CONTENT: r_s = 0.12; p = 0.60).

Conclusion: 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.

Keywords: Concussion; Intervention; Randomized controlled trial; Systematic review.

Publication types

Review