PTJ Policy Physical Therapy Trials that began participant enrollment AFTER January 1, 2009, must be...
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![Page 1: PTJ Policy Physical Therapy Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment.](https://reader036.fdocuments.us/reader036/viewer/2022082613/5697bf911a28abf838c8e5d3/html5/thumbnails/1.jpg)
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.
![Page 2: PTJ Policy Physical Therapy Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment.](https://reader036.fdocuments.us/reader036/viewer/2022082613/5697bf911a28abf838c8e5d3/html5/thumbnails/2.jpg)
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.
![Page 3: PTJ Policy Physical Therapy Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment.](https://reader036.fdocuments.us/reader036/viewer/2022082613/5697bf911a28abf838c8e5d3/html5/thumbnails/3.jpg)
Physical Therapy
![Page 4: PTJ Policy Physical Therapy Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment.](https://reader036.fdocuments.us/reader036/viewer/2022082613/5697bf911a28abf838c8e5d3/html5/thumbnails/4.jpg)
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
![Page 5: PTJ Policy Physical Therapy Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment.](https://reader036.fdocuments.us/reader036/viewer/2022082613/5697bf911a28abf838c8e5d3/html5/thumbnails/5.jpg)
PTJ Editorial Office Matrix
Physical Therapy
![Page 6: PTJ Policy Physical Therapy Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment.](https://reader036.fdocuments.us/reader036/viewer/2022082613/5697bf911a28abf838c8e5d3/html5/thumbnails/6.jpg)
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
![Page 7: PTJ Policy Physical Therapy Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment.](https://reader036.fdocuments.us/reader036/viewer/2022082613/5697bf911a28abf838c8e5d3/html5/thumbnails/7.jpg)
Content Review Team
Physical Therapy
• Editorial Board Member & Reviewers Content expertise
![Page 8: PTJ Policy Physical Therapy Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment.](https://reader036.fdocuments.us/reader036/viewer/2022082613/5697bf911a28abf838c8e5d3/html5/thumbnails/8.jpg)
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