In order to improve the quality of a scientific manuscript, the presentation of the results, and the accuracy of the conclusions made, authors of randomized controlled trials should closely follow the suggestions of medical journal reviewers and editors during the peer-review process. Nevertheless, following the publication of a clinical trial in a medical journal, the authors should possess the right to transparently respond to published letters to the editor regarding their trial, in order to adequately and directly address the issues raised in such letters, so long as the response is accurate, relevant, an appropriate length, and maintains a professional tone.
More specifically, we believe the reader is entitled to hear the authors’ response, not the watered-down and politically correct editor’s (or journal board members’) response. This is the reason why we have chosen to publish our response online, rather than in the Journal of Orthopaedic & Sports Physical Therapy (JOSPT). We reserve the right to respond in a direct and transparent fashion in order to identify a “double standard” that evidently exists in the journal and publishing community of the physical therapy profession. We believe our response below is accurate. Furthermore, we believe the “double standard” identified below in item 6 needs to be openly discussed. It is the elephant in the room. It can no longer be ignored.
Below is our response to the two letters to the editor regarding our shoulder randomized clinical trial that was published in the February 2021 issue of JOSPT.
We would like to thank the authors for their letter to the JOSPT editor and for their constructive critique of our trial, “Spinal Manipulation and Electrical Dry Needling in Patients with Subacromial Pain Syndrome: A Multicenter Randomized Clinical Trial.”4 In short, we believe that we have already provided a completely transparent declaration of potential competing interests that is comprehensive and readily visible on the first page of the trial for all to read. Nevertheless, we will specifically address several other items that were raised in the correspondence concerning our trial.
- Unlike drug trials, and particularly in the field of orthopaedic manual physical therapy, the “the degree of practitioner expertise in applying the experimental interventions”16 often requires formalized training—i.e., certifications and/or fellowship training in dry needling, spinal manipulation, etc.—which comes with an inherent potential for clinical bias.7 Notably, we have clearly acknowledged the presence of, and potential influence of such, in our statement within the last paragraph of the limitations section.
- We do not believe the notion of “clinical bias” is confined to practicing clinicians, clinical experts that teach weekend post-graduate continuing education courses, or faculty of fellowship programs. Academic-only faculty within entry-level DPT programs may have an interest in designing and publishing trials that support the existing coursework—that they likely developed, have been teaching for some years, and are comfortable demonstrating with student physical therapists—and/or that fits with the existing philosophy and curriculum of that specific physical therapy program. In addition, university faculty commonly use research publications (i.e., the number of articles published, the quality of the journals that publish the articles, and the impact of the findings) for professional advancement, including: promotions, tenure, speaking engagements, research grants, textbook publishing fees or royalties, etc. Further, each of these are often associated with significant financial gain and notoriety; however, such competing interests are rarely identified when ‘academic-only’ faculty publish their research in scientific journals.
- While clinical and/or personal equipoise are considered by some to be the sacred dogma of research ethics, a consistent definition of equipoise presently does not exist, and the concept continues to be a topic of debate throughout the literature.8, 15 According to bio-ethicist Benjamin Freedman,5 the requirement for investigators to have no treatment preference “presents nearly insuperable obstacles to the ethical commencement or completion of a controlled trial….” Rather, the “imminent controversy in the preferred treatment” among the scientific community and/or medical profession is enough to satisfy the genuine uncertainty requirement of clinical equipoise.5 Given that clinical equipoise is rarely mentioned in clinical trials and lacks a standardized and empirically stable meaning, a recent cross-sectional analysis of the ethics and science of randomized controlled trials recommended that the term clinical equipoise be questioned and abandoned.3
- While Drs. Dunning, Butts and Young are co-authors of the trial, we did not participate in the recruitment, examination, random allocation, treatment delivery, follow-up assessments or data collection of a single patient. We never met any of the patients in the trial. As such, we do not see how the primary and secondary outcomes (i.e., shoulder pain intensity as measured by the NPRS, disability as measured by the SPADI, self-perceived improvement as measured by the GROC, and medication intake as measured by a self-administered 5-point Likert scale) could have been affected by the personal or clinical preferences of Drs. Dunning, Butts and Young.
- The trademarks associated with AAMT (i.e., Cert. SMT, Cert. DN, Dip. Osteopractic) are not a source of income. In fact, they are an expense. Notably, there remains no title protection for physical therapists following the completion of an APTA-accredited residency (i.e., “Orthopaedic” Physical Therapist) or an APTA-accredited fellowship (i.e., “Orthopaedic Manual” Physical Therapist). For this reason, we applied for and were awarded a trademark registration by the U.S. Patent and Trademark Office to protect the credentials that AAMT graduates have earned from being used by physical therapists (or other unlicensed practitioners) that haven’t completed the appropriate training in that specialty area of practice. Notably, this also protects the public—i.e., patients—from practitioners that may claim or advertise expertise, specialty practice, or credentials they have not earned, had formal training in, or successfully completed.
- According to the author of the first letter to the editor, “academic competing interests exist when one teaches or has written extensively on certain material.” In this regard, we believe a double standard exists. For example, the two lead authors in the following publications are owners, partners and/or instructors for the International Spine and Pain Institute. These two authors have published extensively on cervical manipulation11, 13 and pain neuroscience education;9, 10, 12 in addition, they also actively teach weekend continuing education courses in spinal manipulation and pain neuroscience as part of the certifications they offer. Nevertheless, no declaration of potential competing interests (of any kind) was made. Notably, three of the articles were published in JOSPT9, 11, 13 and the aforementioned authors declared that they had “no affiliations with or financial involvement with a direct financial interest in the subject matter of material discussed in the article.” Similarly, two other prominent physical therapists, both owners and/or executive officers for Evidence in Motion—a private, for-profit continuing education corporation that offers weekend courses on the management of neck pain, low back pain and other musculoskeletal disorders—did not declare any potential conflicts or competing interests on publications related to clinical prediction rules,6 guideline adherent physical therapy for low back pain,2 and clinical practice guidelines for neck pain.1 The list could go on; however, we believe we have sufficiently illustrated our point. There seems to be a double standard regarding the disclosure of potential competing interests in some journal and researcher communities.
As Dr. David Sackett so eloquently stated in the British Medical Journal in his seminal commentary titled Evidence-based medicine: what it is and what it isn’t, “The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice.”14 Therefore, rather than giving the green light for the publication of clinical trials to only non-clinical, academic-only faculty in entry-level DPT programs, that in some cases haven’t seen real patients in decades, we believe the profession of physical therapy would be well-served if more clinical experts, practicing clinicians, residency and fellowship program directors took a lead role in the design and publication of clinically relevant research trials.
With kind regards,
James Dunning, PhD, DPT, MSc, FAAOMPT
Raymond Butts, PhD, DPT, MSc
Ian Young, DSc, PT, OCS, SCS
REFERENCES
1. Childs JD, Cleland JA, Elliott JM, et al. Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008;38:A1-A34.
2. Childs JD, Fritz JM, Wu SS, et al. Implications of early and guideline adherent physical therapy for low back pain on utilization and costs. BMC Health Serv Res. 2015;15:150.
3. De Meulemeester J, Fedyk M, Jurkovic L, et al. Many randomized clinical trials may not be justified: a cross-sectional analysis of the ethics and science of randomized clinical trials. J Clin Epidemiol. 2018;97:20-25.
4. Dunning J, Butts R, Fernandez-de-Las-Penas C, et al. Spinal Manipulation and Electrical Dry Needling in Patients With Subacromial Pain Syndrome: A Multicenter Randomized Clinical Trial. J Orthop Sports Phys Ther. 2021;51(2);72-81.
5. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141-145.
6. Fritz JM, Childs JD, Flynn TW. Pragmatic application of a clinical prediction rule in primary care to identify patients with low back pain with a good prognosis following a brief spinal manipulation intervention. BMC Fam Pract. 2005;6:29.
7. Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet. 2002;359:248-252.
8. Hey SP, London AJ, Weijer C, Rid A, Miller F. Is the concept of clinical equipoise still relevant to research? BMJ. 2017;359:j5787.
9. Louw A, Puentedura EJ, Zimney K, Schmidt S. Know Pain, Know Gain? A Perspective on Pain Neuroscience Education in Physical Therapy. J Orthop Sports Phys Ther. 2016;46:131-134.
10. Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016;32:332-355.
11. Puentedura EJ, Cleland JA, Landers MR, Mintken PE, Louw A, Fernandez-de-Las-Penas C. Development of a clinical prediction rule to identify patients with neck pain likely to benefit from thrust joint manipulation to the cervical spine. J Orthop Sports Phys Ther. 2012;42:577-592.
12. Puentedura EJ, Flynn T. Combining manual therapy with pain neuroscience education in the treatment of chronic low back pain: A narrative review of the literature. Physiother Theory Pract. 2016;32:408-414.
13. Puentedura EJ, Landers MR, Cleland JA, Mintken PE, Huijbregts P, Fernandez-de-Las-Penas C. Thoracic spine thrust manipulation versus cervical spine thrust manipulation in patients with acute neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2011;41:208-220.
14. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312:71-72.
15. Shamy M, Dewar B, Fedyk M. Different meanings of equipoise and the four quadrants of uncertainty. J Clin Epidemiol. 2020;127:248-249.
16. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009;62:464-475.
OSTEOPRACTIC 