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Letters and Responses |
 | Are Physical Agents the Same as Rehabilitation? |
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It would appear that a purpose of the selection criteria for studies evaluated by the Philadelphia Panel members was to a priori exclude the very interventions that have some demonstrated efficacy in the treatment of musculoskeletal disorders, in particular manual therapy (manipulation/mobilization). The relative uselessness of most physical agents as stand-alone interventions is well established, and it would seem to be a tremendous waste of resources to further study these interventions and ignore interventions that are used by physical therapists and that have some documented efficacy, such as manipulation. The Guide to Physical Therapist Practice2(pp118–119) clearly outlines manual therapy techniques (including mobilization/manipulation) as procedural interventions used by physical therapists. Unfortunately, these interventions were excluded from consideration. If we included these interventions as part of our practice, why were they excluded from this systematic review? Were these interventions excluded because there is a "sufficient body of knowledge supporting their use or less frequent use"?1(p1631)
The Philadelphia Panel members never explicitly stated the reason for this omission in the methods section. As faculty members in programs grounded in an evidence-based practice framework, we routinely teach and test students on mobilization and manipulation skills used in physical therapist management of musculoskeletal problems, particularly those with demonstrated efficacy in the management of spinal and extremity disorders.3–7 We can only assume the reason that these forms of rehabilitation were noticeably absent from this series was because a sufficient body of knowledge exists. However, many Journal readers may not be familiar with this evidence. Consequently, we are concerned that this issue of the Journal will provide more than ample opportunity to further reduce our profession from one that provides a wide range of rehabilitation strategies based on a thorough examination of our patients to a profession that applies a few physical agents.
The Guest Editor of this special issue previously stated:
Over the past 10 years, for example, we have seen some very compelling evidence supporting manipulation for patients with acute LBP [low back pain], yet manipulation is used by physical therapists in typical outpatient settings at a lower-than-expected rate....What seems to be incontrovertible is the fact that evidence exists to support the use of certain treatment procedures for patients with LBP and, like other health care professionals, physical therapists' behavior, in many instances, does not comply with such guidelines.8(p706)
Evidently, we should add that panel members' and editors' behavior, in many instances, does not comply with such guidelines. Is it little wonder that physical therapists use these interventions at lower-than-expected rates when our own reviews fail to include these interventions?
In closing, as advocates of evidence-based practice, we must stress that we strongly support critical appraisal of the literature, the use of a hierarchy of evidence for making treatment decisions, and the need to summarize evidence into practice guidelines.9 It is for these reasons that we are disappointed that the Philadelphia Panel reviews deliberately ignored treatments such as mobilization and manipulation that have been shown to be efficacious in certain disorders and instead focused on other treatments whose relative uselessness is fairly well established. It is difficult to promote the increased use of treatments such as manual therapy that are supported by evidence within the profession when our professional journal publishes practice guidelines that appear to indicate that such treatments are not a part of our practice. Montori and Guyatt10 have provided an excellent framework for identifying bias in systematic reviews, including the criteria for inclusion and exclusion of primary studies, and we would encourage the Journal readership to seek out this source for more information. The Philadelphia Panel guidelines provide an excellent example of professional bias in the literature against certain treatment approaches. Therefore, we will accept Dr Rothstein's and Dr Delitto's challenge to discuss this in the classroom and the clinic.
Associate Professor and Director
US Army-Baylor University Graduate Program in Physical Therapy
3151 Scott Rd
San Antonio, TX 78234
Department of Physical Therapy
University of Pittsburgh
Room 6035, Forbes Tower
Pittsburgh, PA 15260
Assistant Professor
US Army-Baylor University Graduate Program in Physical Therapy
Associate Graduate Faculty
US Army-Baylor University
Post-Professional Doctoral Program in Orthopaedic and Manual Physical Therapy
Brooke Army Medical Center
San Antonio, TX 78234
References
Although attempts to isolate individual effects are desirable in basic research, applied clinical research questions are often better answered by studying realistic clinical treatment regimens. Most of our practice remains undefined thanks to a slavish adherence to the reductionist approach. Physical therapist researchers have labored in vain to tease out the effects of each form of modality, exercise, or technique without capturing the measurable clinical benefit of the appropriate combination of therapy tailored to the impairments found in the individual patient. We must study the effects of physical therapy as it is practiced in the clinic.
The insistence on a reductionist approach simply misses the point that physical therapy can never be practiced without a combination of effects at the system, tissue, cellular, or behavioral level. The effects of rehabilitation interventions are multifactorial in nature; a reductionist approach to clinical research by its very nature excludes the often powerful interaction effects realized using a combined treatment approach. A logical progression for clinical research would be for an experienced provider to observe consistent clinical benefit with a specific form of treatment. A case series could help the provider determine whether those results are reproducible in multiple patients. The next step would be to subject the intervention to the rigors of a randomized controlled clinical trial. If the treatment as performed in the clinic is determined to have substantial benefit, subsequent trials could tease out the relative contribution of each treatment or stimulus to the significant overall treatment effect.
When a randomized controlled clinical trial with an intention-to-treat analysis and a 1-year follow-up is selected for publication as the lead article in a prominent medical journal, it is suggestive of scientific merit. When that same article is selected for Mosby's Yearbook of Medicine and positively reviewed by the Journal for Evidence Based Medicine, the American College of Physicians Journal Club, the Journal of Bone and Joint Surgery, The Physician and Sportsmedicine, and the Journal of Family Practice, it would seem to be a credible study of clinical importance. When that study is awarded the Rose Excellence in Research Award for 2001 by the Orthopaedic Section of the American Physical Therapy Association, it suggests the research merits recognition and is of importance to the practice of physical therapy. Given the overwhelmingly positive reviews in other venues, we find it disappointing that this study3 was excluded from consideration in the Philadelphia Panel Evidence-Based Clinical Practice Guidelines.
Even more confusing was the exclusion of another study4 that clearly did separate the effects of manual physical therapy combined with exercise from exercise alone. If the former study was excluded based on the inability to determine the respective contribution of exercise and manually applied treatment, this study would seem to have been a logical choice for inclusion in the Philadelphia Panel Evidence-Based Clinical Practice Guidelines.
In summary, we are perplexed that clinically meaningful research that ranks high on the evidence hierarchy,5 that includes patient-focused outcomes, and that has been largely embraced by the medical community can be categorically discarded for the purposes of this review.
Chief, Physical Therapy
Brooke Army Medical Center
3851 Roger Brooke Dr
San Antonio, TX 78218
Chief, Physical Therapy
Madigan Army Medical Center
9040A Reid St
Tacoma, WA 98431
Director, US Army-Baylor University
Postprofessional Doctoral Program in Orthopaedic and Manual Physical Therapy
Assistant Professor, Baylor University Graduate School
Brooke Army Medical Center
Faculty, US Army-Baylor University
Post-professional Doctoral Program in Orthopaedic and Manual Physical Therapy
Assistant Professor, Baylor University Graduate School
Brooke Army Medical Center
Faculty, US Army-Baylor University
Post-professional Doctoral Program in Orthopaedic and Manual Physical Therapy
Assistant Professor, Baylor University Graduate School
Brooke Army Medical Center
US Army War College
122 Forbes Ave
Carlisle Barracks, PA 17013
References
Flynn and associates state that in reference to manual therapy techniques: "Is it little wonder that physical therapists use these interventions at lower-than-expected rates when our own reviews fail to include these interventions?" I am not sure how they define "our own reviews." The panel report does not belong to the profession, and that was made clear in the articles. It dealt with rehabilitation interventions that can be used by many types of practitioners. Our Journal was honored to be chosen as the preferred venue for carrying information that the authors believe should govern the practice of all health care professionals, including physicians and chiropractors, in rehabilitation.
The panel report consisted of materials sent to the Journal for peer review, materials that dealt with rehabilitation interventions. I see no basis for Flynn and colleagues' contention that harm was done to the cause of manual therapy because "our professional journal publishes practice guidelines that appear to indicate that such treatments are not a part of our practice." Harm is done when accusations are made without foundation and when defensiveness leads to ignoring of facts. Misrepresenting what the panel did does not add to evidence-based practice but rather to an atmosphere in which nonconstructive criticism replaces meaningful dialogue.
Manual therapy was not given the kind of consideration many of us would have preferred in the panel report. The limitations and focus of the report were acknowledged in the text and titles, just as they should be in any such report. Clearly, not all possible interventions were considered. Again, I wish they had been, but an editor's wishes are rarely met, and the articles, in the opinion of our peer reviewers, were highly credible for the topics they covered. There were limitations, as is the case for almost all articles we publish.
I learned a long time ago that the best way to get your topic studied is to conduct the research yourself. In this case, that means there is ample room for others to enhance the panel report by conducting systematic reviews that include interventions omitted by the Philadelphia Panel. The Journal does not demand that authors do what its editors or reviewers would have done. Our job is to determine whether submitted materials are credible, meaningful, and contribute to our knowledge and whether there is proper characterization of limitations.
I am left with more questions than answers, and I expect I am not alone. In our attempt to show evidence of efficacy, could we be too narrow in defining what constitutes evidence? Are we too narrow in measuring our outcomes? How much of what we observe as evidence when our patients improve might be due to a placebo effect? And how detrimental is the randomized controlled trial in identifying a placebo effect? Dr Anne Harrington of the Department of the History of Science at Harvard University suggested that only when our research began to measure very real physical effects of placebo did placebo come to be seen as a confounding variable in research.1 I contend that some cultures (eg, certain Asian cultures) tend to view nonspecific benefits as being part of the individuality of the healing process. I also would argue that some cultures do not even try to control for variables or to separate the physical from the metaphysical. Perhaps they are not driven by showing cause and effect in health care.
The National Institutes of Health is currently funding studies that are looking at the placebo effect.2 According to the Web site for the National Center for Complementary and Alternative Medicine of the National Institutes of Health (http://nccam.nih.gov/fi/concepts/rfa) there are 2 program announcements inviting applications addressing different aspects of placebo. Data have shown that patient expectation has a lot to do with outcome.3–5 Physical therapists may transfer enthusiasm to patients about the procedures that they have found helpful with other patients. It would be important to be able to identify whether this transfer of enthusiasm is, in fact, a "modality" that plays a critical role in enhancing the healing of our patients, but we have not sufficiently looked into the mechanisms that underlie the placebo response in our patients. Are these mechanisms primarily psychological? Neurological? Culturally conditioned? We need to continue expanding our views of what constitutes "evidence" and start keeping precise statistics on what are described as "nonspecific" effects.
The Philadelphia Panel's results are shocking in many ways. If we take these results as a record of the true measure of what in physical therapy constitutes "helpful help," we might reduce the musculoskeletal curriculum by two thirds. But let's not get carried away with too narrow a response to these data. Let's use this information as a way of expanding our observations of clinical efficacy and start taking into account outcomes that are not so easy to measure, such as motivation, mood, hope, belief in self, belief in the health care professional, prayer, optimism, and locus of control. Let's expand our ways of collecting data and stop denigrating research efforts other than the randomized controlled trial with placebo. The Sackett approach6 has a place, but I believe that we have lifted his criteria up so high that research has evolved too far from day-to-day clinical practice.
Professor and Associate Director/Curriculum
Division of Physical Therapy
University of Miami School of Medicine
5915 Ponce de Leon Blvd, 5th Floor
Coral Gables, FL 33146-2406
References
If Dr Davis believes that our future as a profession lies in our ability to produce placebo effects, perhaps she misses the point. Her view taken to its logical conclusion would not mean that we could, as she said, "reduce the musculoskeletal curriculum by two thirds," but rather that we could possibly eliminate this aspect of the curriculum in its entirety as we become not physical therapists but rather practitioners of "placebo enhancement." As a curriculum coordinator, Dr Davis should know that this role is not what sets us apart from other practitioners and is not seen as our raison d'être in any practice act or in any document that describes our practice (accreditation expectations, the normative model for physical therapist education, or the Guide to Physical Therapist Practice1). I believe Dr Davis' views to be unwise and reckless and, most importantly, potentially injurious to those patients who expect us to have some basis in science for our practice.
In addition, despite Dr Davis' contentions, RCTs are not the only method that can be used to document practice. I believe that Dr Davis chose to criticize an approach without offering any alternatives. I did not see any references to research that used the kinds of approaches Dr Davis seems to endorse, and I saw no reference by Dr Davis to her own contributions to the literature that she says we need. Lacking such references, I would consider her criticisms to be counterproductive. Dr Davis talks about taking into account things that are difficult to measure. Although I do not completely see their relevance to her arguments, I am shocked that she is unaware of the fact that many of these variables can be measured by existing scales developed within the very humanistic field of psychology. Because variables are difficult to measure does not mean that we can act as if there are data when, in fact, there are none. In noting that the literature is missing studies that take into account the variables Dr Davis thinks are important, she is not criticizing the Philadelphia Panel, but rather herself and her colleagues who share her beliefs. It is they who have failed to provide the evidence for the beliefs that she would like to take for granted in the absence of data.
An RCT that is designed to examine an intervention effect is designed to isolate a specific intervention. Dr Davis sees this as a terrible strategy. Knowing whether an intervention has any value arms the practitioner with knowledge about causality. This does not mean—and is not claimed by the sources cited by Dr Davis, including David Sackett—that in practice we dispense with the beneficial effects of practitioner attitude, faith of the patient, or any other potential additive benefit. Adding humanistic elements to patient care makes sense. I would argue, however, that it is important to know whether you are adding something to nothing or to a treatment that already has benefit. In addition, this is a researchable question. What can also be studied is whether bundled treatments—those, for example, that include elements that Dr Davis thinks are worthwhile—lead to better outcomes than do interventions without placebo enhancement or without other elements thought to be important by advocates of "alternative care."
Rather than bemoaning what we do not know and making a case for a unique use of the term "evidence," I would argue that it would be far more constructive to document whether there is any benefit to what Dr Davis believes are worthwhile additions to practice. If Dr Davis believes that in physical therapy enhanced outcomes occur with certain additions to care, then it is time for those who take views similar to those of Dr Davis to actually provide data. I believe that views such as those expressed by Dr Davis could enrich the profession. There is room, even need, for differeing views and dissent. If, however, there is no effort to be more scientific in expressing those views and no effort to use existing literature when expressing those views, few things could be more harmful. Similarly, I believe the profession is harmed when anyone consistently expresses dissenting views but makes no contribution to our scientific basis through peer-reviewed publication, because then their dissent remains baseless in fact and sustained only by bias.
References
As expected, we are now seeing Letters to the Editor in Chief that point out the omission of manual therapy treatments. Unfortunately, the letter from Flynn et al intimates more than a methodological disagreement, however, and appears to question the motives of the authors as well as those of the Editor in Chief and Guest Editor. I would call particular attention to the statement, "Is it little wonder that physical therapists use these interventions at lower-than-expected rates when our own reviews fail to include these interventions?" Do I really need to remind Flynn and colleagues that no profession can claim ownership to any manuscript printed in the Journal? Dr Davis focuses most of her attention on an apparent lack of accounting for placebo effects in the literature reviewed by the Philadelphia Panel. She goes on to point out possible funding sources for those interested in studying placebo effects. I can see no reason why such funding cannot be sought by those physical therapists interested in studying the effects on outcome attributable to issues such as patient expectations.
Yes, the Philadelphia Panel had a narrow scope of literature to review, which Flynn and colleagues translate as "deliberately" leaving out manual therapy articles from their systematic review. Rather than question the panel's motives, the editorial process, or, in the case of Dr Davis, the inadequacy of research methods, I would ask the authors the following questions:
Where in the October issue does it specifically state that the articles reviewed represent an exhaustive evaluation of all physical therapy interventions for back, neck, shoulder, and knee pain?
What stops others from adding to our scientific body of knowledge: (1) with another systematic review that includes treatments that were not included in the Philadelphia Panel's contribution or (2) with publications that differentiate placebo versus other effects of physical therapy interventions?
With regard to the first question, we do our readership a disservice to assume, as Flynn and colleagues state, that "many Journal readers may not be familiar" with evidence in favor of manual therapy for treatment of lumbar spine conditions. With regard to the second question, I can see no reason why another publication using similar methods and including studies of manual therapy treatments would not be an acceptable and welcome follow-up that would be a supplement to the October publication. Similarly, studies that accurately differentiate the physical and psychological effects of interventions and explain these effects within a sound theoretical framework would greatly enhance our understanding of physical therapist practice.
As "dedicated advocates of evidence-based practice," Flynn and colleagues should realize that the most constructive response to a publication in which the method or scope is questioned is an additional publication that adds to the body of evidence as a whole. Dr Davis, who has long been an advocate of complementary treatment methods, contends that studies focusing on physical versus placebo effects of physical therapy interventions would be welcome additions to our scientific body of knowledge. I would agree with her contention and would welcome such publications, regardless of the research methods used. I would contend that, in future qualitative reviews of the literature, such publications would be much more difficult to ignore than letters to the editor.
Department of Physical Therapy
University of Pittsburgh
Forbes Tower, Room 6035
Pittsburgh, PA 15261
(delitto{at}pitt.edu)
References
We will discuss the comments in detail in order to provide our readers with the best response based on the best evidence that we have available to us. Regarding the comments suggesting that we did not mention physical therapy interventions, it was not our intention to present the whole spectrum of interventions practiced in physical rehabilitation. It is explicitly noted in our articles and reflected in the titles ("selected interventions") that we were including only physical rehabilitation interventions.
We would like to clarify that we excluded manual therapy from our review for several reasons:
We agree with the letter writers that teaching in an evidence-based practice framework is extremely important. We would like to note, however, that there might be some potential publication bias in the references on manual therapy that have been suggested by the letter writers. For example, the referenced articles are not all systematic reviews or meta-analyses, and often the methodology used for development of CPGs is a descriptive approach and expert opinion only, not a quantitative approach. Other well-established meta-analyses and CPGs obtained different results on manual therapy than those obtained by the cited studies.
As contributors to the Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice,9 we promote the importance of using rigorous methodology in the effort to provide physical therapists with strong and valid conclusions about the efficacy of their interventions in daily practice. We certainly invite the physical therapy community to apply rigorous methodology to the existing literature on efficacy of manual therapy and manipulation to derive evidence-based approaches.
In an attempt to examine the efficacy of manual therapy and manipulation, we found that extensive literature already exists.2,10–,22 However, the efficacy of these specific interventions for certain conditions, especially for low back pain, seemed to be controversial, and conflicting evidence exists. Many systematic reviews and CPGs have already been published on manual therapy/manipulation efficacy.1–,7 Furthermore, they all conclude that there is insufficient evidence or conflicting evidence regarding acute and chronic low back pain.
We hope our articles will provide the reader with some guidance in clinical decision making regarding selection of intervention. We have noted above the potential publication biases, which can and do exist in the literature. According to the most recent systematic reviews, there is no clear evidence for all of the clinical applications of manual therapy and manipulation. As we have written in the methods article published alongside the results of the review, "The following interventions were excluded due to either a sufficient body of knowledge or less frequent use: manipulation, manual therapy, swimming exercise, phonophoresis, etc..."
We have gone to extreme lengths to try to avoid publication bias in the interventions we have chosen to study. Regarding the interventions on which we were not asked to conduct systematic reviews, we would be happy to discuss with the letter writers and the authors of previously conducted and published systematic reviews and guidelines whether there is a need for updating these resources in order for clinicians who rely on the best available evidence to make clinical decisions about health care.
We have followed the Cochrane Collaboration methodology and have involved multiple partners, such as the CIGNA Foundation, a large multidisciplinary team, a consensus panel, and patient partners. When readers review the methodology to determine their use of this evidence in making health care decisions, we ask that they be the judge. Our hope is that readers will review our methodology and consider the use of the evidence in making health care decisions about the interventions that were included in our review.
The Philadelphia Panel
References
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