PTJ Policy

Physical Therapy

• Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment begins.

• Trials that began enrollment BEFORE January 1, 2009, must be registered prior to manuscript submission.

• Authors are required to: (1) Specify where the trial is registered and provide the

trial's unique registration number in their cover letter. (2) Include in their cover letter a statement regarding

when enrollment began.

Registries

Physical Therapy

• ClinicalTrials.gov (http://www.clinicaltrials.gov) [FREE]• International Standard Randomized Controlled Trial Number

(http://www.controlled-trials.com/isrctn/)• www.anzctr.org.au• www.umin.ac.jp/ctr/index/htm• www.trialregister.nl• https://eudract.ema.europa.eu/ (new registrations after June

20, 2011)• The World Health Organization (WHO) also has a registry

network.

Physical Therapy

PTJ Editorial Office Intake

Physical Therapy

• Developed a matrix• Determined how the author labels the trial• Trial registration number• IRB approval• Consolidated Standards of Reporting Trials (CONSORT) Checklist

Page numbers in the manuscript

PTJ Editorial Office Matrix

Physical Therapy

Trial Team

Physical Therapy

• Reviews the actual registration and date when the patient was enrolled….if registered AFTER, then immediate reject

• If report of the trial is different from what is in the trial registry, seek author clarification

Content Review Team

Physical Therapy

• Editorial Board Member & Reviewers Content expertise

Issues

Physical Therapy

• Unaware of clinical trial registry• Unclear about design type

Mechanistic studies

• Failure to annotate the CONSORT checklist• Lack of IRB approval• Study underpowered• Substantial changes in reported variables compared with the

trial registry