Randomized Controlled Trial Rehabilitation Checklists

Cochrane Rehabilitation recognizes strengthening the methodology relevant to evidence-based clinical practice as one of its main goals.

The need to improve the quality of conduct and reporting in rehabilitation research has been highlighted by several research activities. Issues such as low replicability of randomized controlled trials and desired items relevant in reporting have been underlined in a scoping review, a research study and two reviews.

To answer to these needs, Cochrane Rehabilitation has launched the Randomized Controlled Trial Rehabilitation Checklists (RCTRACK) project aimed at producing a specific reporting guideline in rehabilitation.

Following a methodology adopted from the CONSORT Group and adapted to the EQUATOR Network suggestions, the project will follow five phases.

  1. The first phase, the Kick-off, is concluded and led to the publication of an article.
  2. In the second phase each of the 8 RCTRACK Working Groups will prepare a systematic or scoping review on one of these 8 topics: (1) patient selection; (2) blinding; (3) treatment group; (4) control groups and co-interventions; (5) attrition, follow-up, and protocol deviation; (6) outcomes; (7) statistical analysis and appropriate randomization; and (8) research questions. This activity will produce a list of items to populate the RCTRACK checklist.
  3. The third will test the proposed checklist through a consensus meeting that will draft the guidelines
  4. The fourth phase will be a Delphi process involving all the rehabilitation research and methodological community
  5. The fifth and last phase is the final consensus meeting and publication.

References:

Arienti C, Armijo-Olivo S, Minozzi S, Tjosvold L, Lazzarini SG, Patrini M, Negrini S. Methodological Issues in Rehabilitation Research: A Scoping Review. Arch Phys Med Rehabil. 2021 Aug;102(8):1614-1622.e14. doi: 10.1016/j.apmr.2021.04.006. Epub 2021 May 11. PMID: 33989598.  PubMed link

Whyte J, Dijkers MP, Fasoli SE, Ferraro M, Katz LW, Norton S, Parent E, Pinto SM, Sisto SA, Van Stan JH, Wengerd L. Recommendations for Reporting on Rehabilitation Interventions. Am J Phys Med Rehabil. 2021 Jan 1;100(1):5-16. doi: 10.1097/PHM.0000000000001581. PMID: 32889858.  PubMed link

Wang D, Taylor-Vaisey A, Negrini S, Côté P. Criteria to Evaluate the Quality of Outcome Reporting in Randomized Controlled Trials of Rehabilitation Interventions. Am J Phys Med Rehabil. 2021 Jan 1;100(1):17-28. doi: 10.1097/PHM.0000000000001601. PMID: 32969969.  PubMed link

Arienti C, Lazzarini SG, Patrini M, Puljak L, Pollock A, Negrini S. The Structure of Research Questions in Randomized Controlled Trials in the Rehabilitation Field: A Methodological Study. Am J Phys Med Rehabil. 2021 Jan 1;100(1):29-33. doi: 10.1097/PHM.0000000000001612. PMID: 33031109.  PubMed link

Negrini S, Chan L, Ferriero G, Frontera W, Heinemann A. Current evidence from the Randomized Controlled Trials Rehabilitation Checklist (RCTRACK) reporting guideline project. Co-published in: 

  • Eur J Phys Rehabil Med. 2020 Dec;56(6):787-789. doi: 10.23736/S1973-9087.20.06635-6. Epub 2020 Oct 13. PMID: 33047946; PMCID: PMC8603787.  PubMed link
  • Am J Phys Med Rehabil. 2021 Jan 1;100(1):2-4. doi: 10.1097/PHM.0000000000001617. PMID: 33048892.  PubMed link
  • Arch Phys Med Rehabil. 2021 Aug;102(8):1665-1667. doi: 10.1016/j.apmr.2021.04.008. Epub 2021 May 12. PMID: 33991486.  PubMed link

Meyer T, Tilly C. Reporting of patients' characteristics in rehabilitation trials: an analysis of publications of RCTs in major clinical rehabilitation journals. Eur J Phys Rehabil Med. 2020 Dec;56(6):829-835. doi: 10.23736/S1973-9087.20.06710-6. Epub 2020 Nov 20. PMID: 33215907.  PubMed link

Armijo-Olivo S, Machalicek W, DE Oliveira-Souza AI, Dennett L, Ballenberger N. Attrition, missing data, compliance, and related biases in randomized controlled trials of rehabilitation interventions: towards improving reporting and conduct. Eur J Phys Rehabil Med. 2020 Dec;56(6):817-828. doi: 10.23736/S1973-9087.20.06427-8. Epub 2020 Nov 9. PMID: 33165311.  PubMed link

Armijo-Olivo S, Machalicek W, Dennett L, Ballenberger N. Influence of attrition, missing data, compliance, and related biases and analyses strategies on treatment effects in randomized controlled trials in rehabilitation: a methodological review. Eur J Phys Rehabil Med. 2020 Dec;56(6):799-816. doi: 10.23736/S1973-9087.20.06428-X. Epub 2020 Nov 9. PMID: 33165312.  PubMed link

Amiri M, Kumbhare D. Randomized controlled trials in non-pharmacological rehabilitation research: a scoping review of the reporting of sample size calculation, randomization procedure, and statistical analyses. Eur J Phys Rehabil Med. 2020 Dec;56(6):790-798. doi: 10.23736/S1973-9087.20.06451-5. Epub 2020 Sep 16. PMID: 32935956.  PubMed link

Armijo-Olivo S, Patrini M, Oliveira-Souza AIS, Dennett L, Arienti C, Dahchi M, Negrini S. Tools to Assess the Risk of Bias and Reporting Quality of Randomized Controlled Trials in Rehabilitation. Arch Phys Med Rehabil. 2021 Aug;102(8):1606-1613. doi: 10.1016/j.apmr.2021.04.007. Epub 2021 May 11. PMID: 33989599.  PubMed link

Dijkers MP. Overview of Reviews Using the Template for Intervention Description and Replication (TIDieR) as a Measure of Trial Intervention Reporting Quality. Arch Phys Med Rehabil. 2021 Aug;102(8):1623-1632. doi: 10.1016/j.apmr.2020.09.397. Epub 2020 Nov 25. PMID: 33245937.  PubMed link

Negrini S, Armijo-Olivo S, Patrini M, Frontera WR, Heinemann AW, Machalicek W, Whyte J, Arienti C; RCTRACK Promoters. The Randomized Controlled Trials Rehabilitation Checklist: Methodology of Development of a Reporting Guideline Specific to Rehabilitation. Am J Phys Med Rehabil. 2020 Mar;99(3):210-215. doi: 10.1097/PHM.0000000000001370. PMID: 31851008.  PubMed link

Arienti C, Armijo-Olivo S, Minozzi S, Lazzarini SG, Patrini M, Negrini S. Methodological issues in rehabilitation research: a scoping review. BMJ Evid-Based Med. 2019;24(Suppl 1):A35-A35. doi:10.1136/bmjebm-2019-EBMLive.68

Negrini S, Arienti C, Pollet J, Engkasan JP, Francisco GE, Frontera WR, Galeri S, Gworys K, Kujawa J, Mazlan M, Rathore FA, Schillebeeckx F, Kiekens C; REREP study participants. Clinical replicability of rehabilitation interventions in randomized controlled trials reported in main journals is inadequate. J Clin Epidemiol. 2019 Oct;114:108-117. doi: 10.1016/j.jclinepi.2019.06.008. Epub 2019 Jun 18. PMID: 31220570.  PubMed link