Editorial Why Publish Study Protocols? n this issue, PTJ publishes “Build Better Bones With Exercise: Protocol for a Feasibility Study of a Multicenter Randomized Controlled Trial of 12 Months of Home Exercise in Women With a Vertebral Fracture.”1 This is not the first protocol paper published in PTJ, but it is the debut of protocols as an official manuscript category in PTJ.

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Clinical trials that adhere to the highest standards of internal and external validity are imperative to best inform optimal decision making for patients. It’s therefore necessary to rule out as many sources of bias and confounders as possible. Factors such as randomization and blinding are integral to minimizing bias in clinical trials, but even the most well-designed studies could be at risk for not getting published if the results are negative or inconsistent with the investigators’ prevailing hypotheses. Once a study protocol is available to the public, however, there is a reasonable expectation to eventually find the results in the literature, which adds an element of accountability for authors to report their results in a timely manner. Reporting of study protocols in advance allows the scientific community to evaluate whether the eventual analysis and results are consistent with the investigators’ original intent. For example, in the cases of studies supported by grant funding, there is a legitimate concern that a sponsor’s interests could interfere with a timely, accurate, and transparent publication of the findings.2,3 Publishing study protocols also informs the scientific community as to what studies are being done, which helps to avoid duplication and to better coordinate research efforts. Finally, making study protocols publicly available has the benefit of disseminating the most contemporary ideas with respect to study design and data analysis.2,3 These concerns have led to the International Committee of Medical Journal Editors (ICMJE) requirement that funded, as well as unfunded, clinical trials be registered with an independent clinical trials registry, such as ClinicalTrials.gov, in advance of the study’s enrollment. ClinicalTrials.gov is a free service of the National Institutes of Health, provided through the National Library of Medicine. Following receipt of the clinical trial information supplied by the author, ClinicalTrials.gov performs a manual review to identify possible errors, deficiencies, or inconsistencies that are not detected automatically during data entry. Upon approval, the clinical trial is issued a registry number. Because PTJ recognizes that publication of study protocols increases research quality and transparency, the leadership of PTJ endorsed a clinical trials registration policy for all reports of clinical trials that began enrollment on or following January 1, 2009. Why is PTJ endorsing the publication of clinical trial protocols in the journal if they already are available at ClinicalTrials.gov and other international trials registries? As mentioned above, clinical trial protocols are essential for study conduct, review, and reporting, thus publication of study protocols allows for timely dissemination of high-quality trial designs, prevention of study duplication, and improved interpretation of study findings.3 Furthermore, study protocol publications differ from the information available at trial registry websites in that these publications can provide additional rationale, background, and organization of the clinical trial beyond what is commonly available in trial registries.4 As a pilot in the process of determining PTJ’s ultimate policy on publishing protocols, 2 protocol manuscripts,5,6 which met the criteria stated below, were published in PTJ’s Special Series on Rehabilitation for People With Critical Illness.7 These 1208 ■ Physical Therapy Volume 94 Number 9

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Editorial 2 articles are among the most highly cited PTJ manuscripts published in the past 2 years, testifying to the value of sharing a study’s protocol prior to the completion of the clinical trial. PTJ will consider publication of study protocols of current, ongoing, and prospective clinical research. The proposed study must meet the following criteria: • Randomized clinical trial registered in a clinical trials registry • Currently funded by a federal or national agency • Current institutional review board (IRB) approval • Submission of a letter assuring PTJ that no part of the study protocol has been previously published or is under consideration for publication Qualifying study protocols will be reviewed by 2 PTJ Editorial Board members and will not undergo peer review, as peer review of the protocol has already taken place during the process of securing funding. The final decision for publication of the study protocol rests with the editor in chief. Preference will be given to studies directly relevant to physical therapy with the potential to make a significant contribution to the profession. Study protocols published in PTJ will be immediately and freely available online and will be indexed in PubMed. Patricia J. Ohtake and John D. Childs P.J. Ohtake, PT, PhD, is a PTJ Editorial Board member and is Associate Professor of Rehabilitation Science, University at Buffalo, New York. J.D. Childs, PT, PhD, MBA, is a PTJ Editorial Board member and is Associate Professor, US Army–Baylor University Doctoral Program in Physical Therapy.

References 1 Giangregorio LM, Thabane L, Adachi JD, et al. Build Better Bones With Exercise: protocol for a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in women with a vertebral fracture. Phys Ther. 2014;94:1337–1352. 2 West R. Trial protocols. Addiction. 2012;107:1544. 3 Smith ME, Martin TP. Publishing trial protocols. Clin Otolaryngol. 2011;36:521–522. 4 Skogvoll E, Kramer-Johansen J. Publication of clinical trial protocols--what can we learn? Scand J Trauma Resusc Emerg Med. 2013;21:12. 5 Kho ME, Truong AD, Brower RG, et al. Neuromuscular electrical stimulation for intensive care unit–acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial. Phys Ther. 2012;92:1564–1579. 6 Brummel NE, Jackson JC, Girard TD, et al. A combined early cognitive and physical rehabilitation program for people who are critically ill: the Activity and Cognitive Therapy in the Intensive Care Unit (ACT-ICU) Trial. Phys Ther. 2012;92:1580–1592. 7 Ohtake PJ, Strasser DC, Needham DM. Rehabilitation for people with critical illness: taking the next steps. Phys Ther. 2012;92:1484–1488. [DOI: 10.2522/ptj.2014.94.9.1208]

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Why publish study protocols?

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