Is This a Clinical Trial? And Should It Be Registered? Rana S. Hinman, Rachelle Buchbinder, Rebecca L. Craik, Steven Z. George, Chris G. Maher and Daniel L. Riddle PHYS THER. 2015; 95:810-814. doi: 10.2522/ptj.2015.95.6.810
The online version of this article, along with updated information and services, can be found online at: http://ptjournal.apta.org/content/95/6/810 Collections
This article, along with others on similar topics, appears in the following collection(s): All Editorials Evidence-Based Practice Professional Issues Randomized Controlled Trials Rebecca Craik
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Editorial Is This a Clinical Trial? And Should It Be Registered?
P
TJ strives to improve its processes to enhance readability, simplify manuscript submission for authors, and ensure that only papers with a reasonable likelihood of publication proceed to full review—all with the goal of publishing high-quality, clinically relevant content. In particular, manuscripts reporting clinical trials must be prospectively registered in a publicly accessible trial registry before participant enrollment commences. Although PTJ has required clinical trial registration since 2008, the definition of a clinical trial continues to perplex some authors. Confusion may result in failure to prospectively register a trial, thus preventing PTJ (and many other journals) from publishing the study findings once the study has been completed.
So, what is a clinical trial? The National Institutes of Health (NIH) revised its definition of clinical trials in October 2014 in order to more clearly distinguish between clinical trials and clinical research studies.1 The NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The NIH considers prospective assignment (which may involve randomization but not necessarily) to be a predefined process specified in a protocol that stipulates the assignment of research participants (individually or in clusters) to one or more arms of a clinical trial. The NIH1 defines an intervention as: . . . manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
A health-related biomedical or behavioral outcome is defined as1: . . . the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.
To comment, submit a Rapid Response to this editorial posted online at: ptjournal.apta.org.
810
f
Physical Therapy
Increasingly, PTJ receives manuscripts describing clinical trials where the intervention is directed at the therapist, and therapists rather than patients are assigned to the intervention groups (eg, a trial evaluating the efficacy of an education intervention designed to improve physical therapists’ knowledge about a particular condition). These types of trials may measure outcomes at the therapist/provider level rather than at the patient level. Although these studies are considered clinical trials, it is the trial outcomes that determine whether prospective registration in a trial registry is required. PTJ has adopted the approach of the International Committee of Medical Journal Editors,2 which states that “if the purpose of the trial is to examine the effect of the provider intervention on the health outcomes of the providers’ patients, then investigators should Volume 95 Number 6 Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
June 2015
Editorial
Figure. Decision tree for clinical trials and trial registration. Adapted from the National Institutes of Health.1
register the trial. If the purpose is to examine the effect only on the providers (for example, provider knowledge or attitudes), then registration is not necessary.” What does prospective registration of a trial entail? Prospective clinical trial registration involves documenting the protocol in a trial registry prior to the first participant being enrolled. Clinical trial registration is important for a variety of reasons. Registration overcomes problems of selective reporting (where researchers report only June 2015
Volume 95 Number 6 Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
Physical Therapy f
811
Editorial favorable results from clinical trials) and publication bias (where trials with favorable or significant results are more likely to be published than those with negative or nonsignificant findings). Prospective registration also helps minimize needless duplication of trials by alerting researchers to trials that are already underway. The International Society of Physiotherapy Journal Editors (ISPJE) endorses a policy of mandatory prospective registration of clinical trials in a public trials registry as a condition for considering a manuscript for publication.3 PTJ was one of the first physical therapy/rehabilitation journals to implement such a policy and has required prospective trial registration for trials that commenced participant recruitment after January 2009. Trial registration is not only an issue of good research practice; it also is consistent with ethical principles outlined by the Declaration of Helsinki,4 which advocates that research studies involving human subjects are registered in a publicly accessible database before enrollment of the first subject. In most countries, the codes of conduct governing research require investigators to conform to the Declaration. Although registration of clinical trials published in physical therapy journals is increasing, only 48% of clinical trials published in 2012 in physical therapy journals were registered,5 showing that the profession still has quite a way to go. BMJ recently highlighted the lower registration rates for trials of nonregulated interventions compared with the registration rates of trials of regulated interventions6 and called for improved transparency in clinical trials of nonregulated interventions. Over the past few months, the PTJ Editorial Board has reviewed both our policies governing registration of clinical trials and our instructions to authors on the PTJ website. As a result of this review, we have implemented changes that we hope will assist researchers in deciding whether their study requires prospective registration in a clinical trials registry: • As of July 1, 2015, PTJ has adopted the NIH definition of a clinical trial and has adapted the NIH clinical trial decision tree to assist researchers in determining whether a study is a clinical trial, and, if so, whether it needs prospective registration (Figure). Going forward, the Editorial Board will use this decision tree to decide whether a manuscript should be classified as a clinical trial. See examples on page 814. • For manuscripts submitted July 1, 2015, and thereafter, PTJ requires all clinical trials with patient-level outcome measures to be prospectively registered in a trial registry. Such clinical trials that have not been prospectively registered will be rejected at prescreening. See examples on page 814.
We hope that our authors and readers continue to support PTJ’s efforts to ensure that clinical trials are conducted and reported according to best practices, including a publicly available, prespecified trial protocol. We encourage authors to visit the World Health Organization’s trial registration site7 for guidance in how to register a trial or identify an appropriate trial registry. Rana S. Hinman, Rachelle Buchbinder, Rebecca L. Craik, Steven Z. George, Chris G. Maher, Daniel L. Riddle R.S. Hinman, PT, PhD, is a PTJ Editorial Board member. She is associate professor, Department of Physiotherapy, Centre for Health, Exercise & Sports Medicine, University of Melbourne, Melbourne, Victoria, Australia. Address all correspondence to Dr Hinman at: [email protected] R. Buchbinder, MBBS (Hons), MSc, PhD, FRACP, is a PTJ Editorial Board member. She is a rheumatologist and director, Monash Department of Clinical Epidemiology, Cabrini Institute, and a professor within the Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
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Volume 95 Number 6 Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
June 2015
Editorial R.L. Craik, PT, PhD, FAPTA, is Editor in Chief, PTJ. She is a professor and dean, College of Health Sciences, Arcadia University, Glenside, Pennsylvania. S.Z. George, PT, PhD, is a PTJ Editorial Board member. He is associate professor and director, Doctor of Physical Therapy Program, and director, Brooks-PHHP Research Collaboration, University of Florida, Gainesville, Florida. C.G. Maher, PT, PhD, is a PTJ Editorial Board member. He is professor of physiotherapy and director, The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia. D.L. Riddle, PT, PhD, FAPTA, is Deputy Editor, PTJ. He is the Otto D. Payton Professor of Physical Therapy and Orthopaedic Surgery, Virginia Commonwealth University, Richmond, Virginia.
References 1 National Institutes of Health. Clinical Research Policy. Clinical Trials. Available at: http://osp.od.nih.gov/ office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials. Accessed April 27, 2015. 2 International Committee of Medical Journal Editors. Frequently asked questions. Clinical trials registration. Available at: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration. Accessed April 27, 2015. 3 Costa LO, Lin CW, Grossi DB, et al. Clinical trial registration in physical therapy journals: recommendations from the International Society of Physiotherapy Journal Editors. Phys Ther. 2013;93:6 –10. 4 World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. Available at: http://www.wma.net/en/30publications/10policies/b3. Accessed April 27, 2015. 5 Babu AS, Veluswamy SK, Rao PT, Maiya AG. Clinical trial registration in physical therapy journals: a cross-sectional study. Phys Ther. 2014;94:83–90. 6 Dal-Re´ R, Bracken MB, Ioannidis JPA. Call to improve transparency of trials of non-regulated interventions. BMJ. 2015;350:h1323. 7 World Health Organization. International Clinical Trials Registry Platform (ICTRP). Trial Registration. Available at: http://www.who.int/ictrp/trial_reg/en/index1.html. Accessed April 28, 2015. [DOI: 10.2522/ptj.2015.95.6.810]
June 2015
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Editorial Clinical Trial Registration: Case Examples
Study #1: A study will compare the effects of a multimodal physical therapy program with the effects of an educational control intervention in adults with low back pain. Participants will be randomly assigned to intervention and control groups. Outcomes include measures of participant physical function and quality of life. Is this study a clinical trial? Yes; the study involves human participants who will be prospectively assigned to an intervention, and it uses health-related biomedical outcomes. Does this study require prospective registration? Yes; the study assesses the effect of the intervention on the health-related outcomes of the patient.
Study #2: A study will monitor the outcomes of a group of patients following stroke who choose to try electrical stimulation treatment for 3 months. Their outcomes will be compared with those of the patients who decline to undergo electrical stimulation. Joint range of motion is the only outcome of interest. Is this study a clinical trial? No; although this observational study involves human participants and uses a health-related biomedical outcome (joint range of motion), the participants are not prospectively assigned to the intervention (they decide themselves whether they want the intervention). Does this study require prospective registration? No; the study is not a clinical trial.
Study #3: A study will evaluate whether an educational intervention for physical therapists improves the therapist’s adherence to clinical guideline recommendations for people with osteoarthritis. Therapists will be randomly assigned to the intervention group (a 2-day educational program) or the control group (usual practice). Outcomes will be measured after 6 months by auditing treatment notes to determine the proportion of therapists who prescribe strengthening exercises for patients with osteoarthritis. Is this study a clinical trial? Yes; the study involves human participants (physical therapists) who will be prospectively assigned to an intervention, and it uses health-related behavioral outcomes (proportion of therapists who prescribe strengthening exercise). Does this study require prospective registration? No; the health-related behavioral outcomes are measured only at the provider level, and not at the patient level. Note: if this study also measured health-related behavioral outcomes at the patient level (eg, the uptake of advice to exercise), this study would need prospective registration.
Study #4: A large national study aims to determine the effectiveness of reducing sedentary classroom time on children’s physical activity levels measured via questionnaire and accelerometry. Schools will be randomly allocated to the control group (usual practice) or a multifactorial intervention that includes provision of standing desks and teacher education to reduce sitting time in class. Is this study a clinical trial? Yes; the study involves human participants within schools (clusters) who will be prospectively assigned (in clusters) to an intervention, and it uses health-related behavioral outcomes (measures of physical activity). Does this study require prospective registration? Yes; the health-related behavioral outcomes are measured at the level of community participants (school children).
Study #5: A study aims to detect the effects of cognitive-behavioral therapy on measures of pain sensitization in people with fibromyalgia. Participants will be prospectively assigned to 1 of 2 cognitive-behavioral interventions. Quantitative sensory testing will be used to compare outcomes between groups, using measures of vibration sensation and pain thresholds for hot and cold temperatures. Is this study a clinical trial? Yes; the study involves human participants who will be prospectively assigned to an intervention, and it uses health-related biomedical outcomes (vibration sensation and thermal pain thresholds). Does this study require prospective registration? Yes; the health-related biomedical outcomes are measured at the patient level.
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Volume 95 Number 6 Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
June 2015
Is This a Clinical Trial? And Should It Be Registered? Rana S. Hinman, Rachelle Buchbinder, Rebecca L. Craik, Steven Z. George, Chris G. Maher and Daniel L. Riddle PHYS THER. 2015; 95:810-814. doi: 10.2522/ptj.2015.95.6.810
References
This article cites 3 articles, 3 of which you can access for free at: http://ptjournal.apta.org/content/95/6/810#BIBL
Subscription Information
http://ptjournal.apta.org/subscriptions/
Permissions and Reprints http://ptjournal.apta.org/site/misc/terms.xhtml Information for Authors
http://ptjournal.apta.org/site/misc/ifora.xhtml
Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
The online version of this article, along with updated information and services, can be found online at: http://ptjournal.apta.org/content/95/6/810 Collections
This article, along with others on similar topics, appears in the following collection(s): All Editorials Evidence-Based Practice Professional Issues Randomized Controlled Trials Rebecca Craik
e-Letters
To submit an e-Letter on this article, click here or click on "Submit a response" in the right-hand menu under "Responses" in the online version of this article.
E-mail alerts
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Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
Editorial Is This a Clinical Trial? And Should It Be Registered?
P
TJ strives to improve its processes to enhance readability, simplify manuscript submission for authors, and ensure that only papers with a reasonable likelihood of publication proceed to full review—all with the goal of publishing high-quality, clinically relevant content. In particular, manuscripts reporting clinical trials must be prospectively registered in a publicly accessible trial registry before participant enrollment commences. Although PTJ has required clinical trial registration since 2008, the definition of a clinical trial continues to perplex some authors. Confusion may result in failure to prospectively register a trial, thus preventing PTJ (and many other journals) from publishing the study findings once the study has been completed.
So, what is a clinical trial? The National Institutes of Health (NIH) revised its definition of clinical trials in October 2014 in order to more clearly distinguish between clinical trials and clinical research studies.1 The NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The NIH considers prospective assignment (which may involve randomization but not necessarily) to be a predefined process specified in a protocol that stipulates the assignment of research participants (individually or in clusters) to one or more arms of a clinical trial. The NIH1 defines an intervention as: . . . manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
A health-related biomedical or behavioral outcome is defined as1: . . . the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.
To comment, submit a Rapid Response to this editorial posted online at: ptjournal.apta.org.
810
f
Physical Therapy
Increasingly, PTJ receives manuscripts describing clinical trials where the intervention is directed at the therapist, and therapists rather than patients are assigned to the intervention groups (eg, a trial evaluating the efficacy of an education intervention designed to improve physical therapists’ knowledge about a particular condition). These types of trials may measure outcomes at the therapist/provider level rather than at the patient level. Although these studies are considered clinical trials, it is the trial outcomes that determine whether prospective registration in a trial registry is required. PTJ has adopted the approach of the International Committee of Medical Journal Editors,2 which states that “if the purpose of the trial is to examine the effect of the provider intervention on the health outcomes of the providers’ patients, then investigators should Volume 95 Number 6 Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
June 2015
Editorial
Figure. Decision tree for clinical trials and trial registration. Adapted from the National Institutes of Health.1
register the trial. If the purpose is to examine the effect only on the providers (for example, provider knowledge or attitudes), then registration is not necessary.” What does prospective registration of a trial entail? Prospective clinical trial registration involves documenting the protocol in a trial registry prior to the first participant being enrolled. Clinical trial registration is important for a variety of reasons. Registration overcomes problems of selective reporting (where researchers report only June 2015
Volume 95 Number 6 Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
Physical Therapy f
811
Editorial favorable results from clinical trials) and publication bias (where trials with favorable or significant results are more likely to be published than those with negative or nonsignificant findings). Prospective registration also helps minimize needless duplication of trials by alerting researchers to trials that are already underway. The International Society of Physiotherapy Journal Editors (ISPJE) endorses a policy of mandatory prospective registration of clinical trials in a public trials registry as a condition for considering a manuscript for publication.3 PTJ was one of the first physical therapy/rehabilitation journals to implement such a policy and has required prospective trial registration for trials that commenced participant recruitment after January 2009. Trial registration is not only an issue of good research practice; it also is consistent with ethical principles outlined by the Declaration of Helsinki,4 which advocates that research studies involving human subjects are registered in a publicly accessible database before enrollment of the first subject. In most countries, the codes of conduct governing research require investigators to conform to the Declaration. Although registration of clinical trials published in physical therapy journals is increasing, only 48% of clinical trials published in 2012 in physical therapy journals were registered,5 showing that the profession still has quite a way to go. BMJ recently highlighted the lower registration rates for trials of nonregulated interventions compared with the registration rates of trials of regulated interventions6 and called for improved transparency in clinical trials of nonregulated interventions. Over the past few months, the PTJ Editorial Board has reviewed both our policies governing registration of clinical trials and our instructions to authors on the PTJ website. As a result of this review, we have implemented changes that we hope will assist researchers in deciding whether their study requires prospective registration in a clinical trials registry: • As of July 1, 2015, PTJ has adopted the NIH definition of a clinical trial and has adapted the NIH clinical trial decision tree to assist researchers in determining whether a study is a clinical trial, and, if so, whether it needs prospective registration (Figure). Going forward, the Editorial Board will use this decision tree to decide whether a manuscript should be classified as a clinical trial. See examples on page 814. • For manuscripts submitted July 1, 2015, and thereafter, PTJ requires all clinical trials with patient-level outcome measures to be prospectively registered in a trial registry. Such clinical trials that have not been prospectively registered will be rejected at prescreening. See examples on page 814.
We hope that our authors and readers continue to support PTJ’s efforts to ensure that clinical trials are conducted and reported according to best practices, including a publicly available, prespecified trial protocol. We encourage authors to visit the World Health Organization’s trial registration site7 for guidance in how to register a trial or identify an appropriate trial registry. Rana S. Hinman, Rachelle Buchbinder, Rebecca L. Craik, Steven Z. George, Chris G. Maher, Daniel L. Riddle R.S. Hinman, PT, PhD, is a PTJ Editorial Board member. She is associate professor, Department of Physiotherapy, Centre for Health, Exercise & Sports Medicine, University of Melbourne, Melbourne, Victoria, Australia. Address all correspondence to Dr Hinman at: [email protected] R. Buchbinder, MBBS (Hons), MSc, PhD, FRACP, is a PTJ Editorial Board member. She is a rheumatologist and director, Monash Department of Clinical Epidemiology, Cabrini Institute, and a professor within the Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
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Volume 95 Number 6 Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
June 2015
Editorial R.L. Craik, PT, PhD, FAPTA, is Editor in Chief, PTJ. She is a professor and dean, College of Health Sciences, Arcadia University, Glenside, Pennsylvania. S.Z. George, PT, PhD, is a PTJ Editorial Board member. He is associate professor and director, Doctor of Physical Therapy Program, and director, Brooks-PHHP Research Collaboration, University of Florida, Gainesville, Florida. C.G. Maher, PT, PhD, is a PTJ Editorial Board member. He is professor of physiotherapy and director, The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia. D.L. Riddle, PT, PhD, FAPTA, is Deputy Editor, PTJ. He is the Otto D. Payton Professor of Physical Therapy and Orthopaedic Surgery, Virginia Commonwealth University, Richmond, Virginia.
References 1 National Institutes of Health. Clinical Research Policy. Clinical Trials. Available at: http://osp.od.nih.gov/ office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials. Accessed April 27, 2015. 2 International Committee of Medical Journal Editors. Frequently asked questions. Clinical trials registration. Available at: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration. Accessed April 27, 2015. 3 Costa LO, Lin CW, Grossi DB, et al. Clinical trial registration in physical therapy journals: recommendations from the International Society of Physiotherapy Journal Editors. Phys Ther. 2013;93:6 –10. 4 World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. Available at: http://www.wma.net/en/30publications/10policies/b3. Accessed April 27, 2015. 5 Babu AS, Veluswamy SK, Rao PT, Maiya AG. Clinical trial registration in physical therapy journals: a cross-sectional study. Phys Ther. 2014;94:83–90. 6 Dal-Re´ R, Bracken MB, Ioannidis JPA. Call to improve transparency of trials of non-regulated interventions. BMJ. 2015;350:h1323. 7 World Health Organization. International Clinical Trials Registry Platform (ICTRP). Trial Registration. Available at: http://www.who.int/ictrp/trial_reg/en/index1.html. Accessed April 28, 2015. [DOI: 10.2522/ptj.2015.95.6.810]
June 2015
Volume 95 Number 6 Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
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Editorial Clinical Trial Registration: Case Examples
Study #1: A study will compare the effects of a multimodal physical therapy program with the effects of an educational control intervention in adults with low back pain. Participants will be randomly assigned to intervention and control groups. Outcomes include measures of participant physical function and quality of life. Is this study a clinical trial? Yes; the study involves human participants who will be prospectively assigned to an intervention, and it uses health-related biomedical outcomes. Does this study require prospective registration? Yes; the study assesses the effect of the intervention on the health-related outcomes of the patient.
Study #2: A study will monitor the outcomes of a group of patients following stroke who choose to try electrical stimulation treatment for 3 months. Their outcomes will be compared with those of the patients who decline to undergo electrical stimulation. Joint range of motion is the only outcome of interest. Is this study a clinical trial? No; although this observational study involves human participants and uses a health-related biomedical outcome (joint range of motion), the participants are not prospectively assigned to the intervention (they decide themselves whether they want the intervention). Does this study require prospective registration? No; the study is not a clinical trial.
Study #3: A study will evaluate whether an educational intervention for physical therapists improves the therapist’s adherence to clinical guideline recommendations for people with osteoarthritis. Therapists will be randomly assigned to the intervention group (a 2-day educational program) or the control group (usual practice). Outcomes will be measured after 6 months by auditing treatment notes to determine the proportion of therapists who prescribe strengthening exercises for patients with osteoarthritis. Is this study a clinical trial? Yes; the study involves human participants (physical therapists) who will be prospectively assigned to an intervention, and it uses health-related behavioral outcomes (proportion of therapists who prescribe strengthening exercise). Does this study require prospective registration? No; the health-related behavioral outcomes are measured only at the provider level, and not at the patient level. Note: if this study also measured health-related behavioral outcomes at the patient level (eg, the uptake of advice to exercise), this study would need prospective registration.
Study #4: A large national study aims to determine the effectiveness of reducing sedentary classroom time on children’s physical activity levels measured via questionnaire and accelerometry. Schools will be randomly allocated to the control group (usual practice) or a multifactorial intervention that includes provision of standing desks and teacher education to reduce sitting time in class. Is this study a clinical trial? Yes; the study involves human participants within schools (clusters) who will be prospectively assigned (in clusters) to an intervention, and it uses health-related behavioral outcomes (measures of physical activity). Does this study require prospective registration? Yes; the health-related behavioral outcomes are measured at the level of community participants (school children).
Study #5: A study aims to detect the effects of cognitive-behavioral therapy on measures of pain sensitization in people with fibromyalgia. Participants will be prospectively assigned to 1 of 2 cognitive-behavioral interventions. Quantitative sensory testing will be used to compare outcomes between groups, using measures of vibration sensation and pain thresholds for hot and cold temperatures. Is this study a clinical trial? Yes; the study involves human participants who will be prospectively assigned to an intervention, and it uses health-related biomedical outcomes (vibration sensation and thermal pain thresholds). Does this study require prospective registration? Yes; the health-related biomedical outcomes are measured at the patient level.
814
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Volume 95 Number 6 Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
June 2015
Is This a Clinical Trial? And Should It Be Registered? Rana S. Hinman, Rachelle Buchbinder, Rebecca L. Craik, Steven Z. George, Chris G. Maher and Daniel L. Riddle PHYS THER. 2015; 95:810-814. doi: 10.2522/ptj.2015.95.6.810
References
This article cites 3 articles, 3 of which you can access for free at: http://ptjournal.apta.org/content/95/6/810#BIBL
Subscription Information
http://ptjournal.apta.org/subscriptions/
Permissions and Reprints http://ptjournal.apta.org/site/misc/terms.xhtml Information for Authors
http://ptjournal.apta.org/site/misc/ifora.xhtml
Downloaded from http://ptjournal.apta.org/ by guest on November 15, 2015
