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Published byHugo Daniel Modified over 9 years ago
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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.
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Registries Physical Therapy ClinicalTrials.gov (http://www.clinicaltrials.gov) [FREE]http://www.clinicaltrials.gov International Standard Randomized Controlled Trial Number (http://www.controlled-trials.com/isrctn/)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) https://eudract.ema.europa.eu/ The World Health Organization (WHO) also has a registry network.registry network
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Physical Therapy Editorial Office Trial Methods Team Ed Board Members & Reviewers
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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
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PTJ Editorial Office Matrix Physical Therapy
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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
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Content Review Team Physical Therapy Editorial Board Member & Reviewers Content expertise
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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
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