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Dialogue on Evidence in Practice |
To the Editor:
We are members of a multidisciplinary lymphedema special interest group in northern Virginia. Our group includes physical therapists, occupational therapists, registered nurses, and massage therapists who are trained in the Vodder, LeDuc and Casley-Smith methods of complete decongestive therapy (CDT), which is sometimes referred to as comprehensive physical therapy or complex physical therapy (CPT). We would like to address several important concerns we have about the "Evidence in Practice" article in the March 2002 issue. These concerns fall into 3 general areas: the examination and treatment of the patient, the evidence gathered, and what we believe to be the disservice done to lymphedema therapists and our patients by publishing this article in a professional journal, which, therefore, implies a standard of practice.
In the patient interview, the author failed to ask questions essential to the history of any patient with lymphedema: when the lymphedema actually started, whether the infections triggered the lymphedema, what the nature of the swelling was, and whether there had been any previous intervention for the lymphedema.
In the examination, important issues were not addressed, including a clear location of the swelling, skin integrity, tissue texture, pitting, fibrosis, radiation changes, axillary web syndrome (also called cording), current signs of infection, and the presence and location of scars. The 11 standard sites of measurement noted by the author were not clear. What was the basis of the standard he cited? As lymphedema therapists, we take measurements at 4-cm intervals and then, utilizing the formula for finding the volume of a cone, we calculate the volume of the limb. The number of measurements, therefore, would depend on the length of the limb. Additional hand measurements also are taken to assess hand swelling.1 There was no indication that the author is trained in these important aspects of assessing lymphedema.
In the third paragraph, the author stated, "the increase in limb size was consistent with chronic lymphedema secondary to radical mastectomy." Was a lymphoscintigraphy performed to allow for a definitive diagnosis? Was the patient tested for metastasis or recurrence of breast cancer and were these conditions ruled out? Was a Doppler ultrasound done to rule out a deep vein thrombosis? What was the stage of the lymphedema? These are important considerations before proceeding with treatment. When describing the components of an intervention program for this patient, the author vaguely and erroneously defined CPT as "some form of external compression...and an exercise program." He left out the other components of CPT—manual lymphatic drainage (MLD), 24-hour compression (initially with short-stretch bandages), exercise with compression on the limb to maximize use of the muscle pump, and education in self-management and lymphedema precautions to minimize risk of infection.2,3
The author's description of the database used and how the search was conducted was very detailed, and it seems clear that researching data is his forte. The author's rationale for limiting his search to CINAHL is a concern. Much of the research on lymphedema and its treatment has been done in Europe and has been published in languages other than English. CINAHL will provide abstracts in English, but the full article is available only in its original published language. More importantly, CINAHL is limited to allied health professions and excludes medical journals. This automatically excludes many of the most important research studies on lymphedema treatment, which can be found in medical journals such as Lancet, Angiology, Lymphology, European Journal of Lymphology, Annals of Plastic Surgery, Oncology, American Journal of Medicine, and Archives of Surgery. The use of a database with these limitations appears to contradict the central purpose of the article, which is to illustrate how best to gather evidence for effective treatment.
The author's discussion of the selection of articles for review is disturbing because, of the 25 articles he found through his search, he chose only 3 articles, 2 of which were literature reviews, and he stated that he started by looking at the title "in the interest of time." He then stated that if he "could not adequately answer [his] question from these 3 articles, [he] could always return to the list of search results to read other articles." He later acknowledged that his review left important questions unanswered, but made his plan of care based on what he "felt...was reasonable," without ever returning to his list of search results for more information. Doesn't this also contradict the notion of effective evidence gathering?
Regarding the issue of infection, which is central to the author's original question, a randomized trial with a control group that did not receive treatment for infection would be unethical, so it is unlikely that a study of this kind would be found. There are other articles that address the issue of infection related to lymphedema,2,4 but the author's search was not broad enough to find them.
The clinical decision part of the article is the most troubling. On the basis of the second article reviewed,5 the author accepted the idea that CPT is no more effective than a compression garment alone. He also made the statement based on a review of a level I study that "this study did not find any additional benefit to adding manual lymph drainage and self-massage." The first study reviewed by the author indicated support for use of pneumatic compression pumps.6 Yet the author decided to use a "comprehensive treatment regimen" that seemed to include all the components of CPT (without pneumatic pumps), despite the fact that his review of the evidence did not support this. After gathering the scientific evidence, he based his decision on treatment modalities on what he "felt was reasonable." Furthermore, the author implied that he would provide the MLD and compression bandaging; however, there was no indication that he was properly trained in these techniques. The implication is that special training is not needed, just some cursory exposure to the technique. Unskilled application of MLD and compression bandages can do more harm than good; therefore, treatment by a qualified therapist is essential.
The author stated that the results of his search for evidence indicated that the "combination of treatments [that] will provide optimal results remains in question." We disagree. We believe that a number of articles2,4,7–12 support a truly comprehensive approach (in the form of qualified CPT) to lymphedema management. The author also showed a lack of appreciation for the proper training and qualifications in treating lymphedema. Lymphedema should not be considered a rehabilitation diagnosis but rather a medical diagnosis and should be treated as such. It should be managed much as diabetes is managed—on a medical level. The assessment and treatment of lymphedema requires specialized training. If a patient with lymphedema ends up in the hands of a non-skilled therapist who does not have a proper understanding of lymphedema (and in this case postmastectomy oncology as well), the outcome for the patient could be life-threatening.
Because this article appeared in a professional journal, it implies that this is the standard of practice for the profession. This is simply not so. There are qualified therapists providing the highest level of lymphedema treatment to our patients. This patient would have been better served by a referral to a trained lymphedema therapist. In conclusion, it is a disservice to the profession and to our patients to hold up the patient care described in this article as an acceptable standard of practice.
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Division of Physical Therapy
The University of British Columbia
T-325-2211 Wesbrook Mall
Vancouver, BC V6T 2B5
Levinson et al have raised 3 general concerns. Their first concern relates to the examination and management of the patient. The "Evidence in Practice" (EiP) series is intended to educate clinicians in strategies for locating peer-reviewed literature to guide their practice. It is a different type of article than a case report, which must provide extensive details of a patient's history, the results of the examination, the anticipated goals and expected outcomes, the interventions, and changes in the patient's status.
Because the case example did not provide the same level of detail as a case report, the information from the patient interview was deemed inadequate by Levinson and colleagues. From my reading of the background information, however, the lymphedema appeared to occur "over the past year" and seemed to be related to the patient's 3 infections. It also appeared that there was no previous treatment for the lymphedema. Levinson and colleagues also have suggested that there should have been more information in the examination (eg, skin integrity, tissue texture, presence of pitting or fibrosis, current signs of infection). I agree that this type of information would have added to our understanding of the patient's present condition, but it would not have changed the primary goal, which was to reduce the upper-extremity swelling.
Levinson et al are concerned that the measurement of limb circumference was not described in more detail. In fact, there is no standardized method for measuring lymphedema in the peer-reviewed literature.1 Moreover, taking measurements at 11 sites is much more comprehensive than what has been recommended in recently published clinical practice guidelines on management of breast cancer–related lymphedema.2
The authors' second concern is that the EiP author gathered deficient evidence because he used the CINAHL database. In fact, 2 of the 3 articles on which the author chose to base his intervention decisions2,3 were published in journals that are also indexed through MEDLINE. Thus, Levinson and colleagues' statement that a CINAHL search excludes "medical journals" is inaccurate because the list of search results included the Canadian Medical Association Journal and the Journal of the National Cancer Institute—both respected medical journals read primarily by physicians. The purpose in choosing CINAHL was to access those physical therapy journals that are not included in Index Medicus (eg, Physiotherapy, Physiotherapy Canada) and to illustrate the diversity of resources available to physical therapists who are searching for evidence.
The authors of this letter were concerned that 2 of the 3 articles cited were "literature reviews." They, however, appear to have confused the definitions of literature reviews, systematic reviews, and clinical practice guidelines. In fact, one article cited was a systematic review3 and the other was a clinical practice guideline by a nationally recognized group of lymphedema experts, which included a physical therapist, a radiation oncologist, a medical oncologist, and a physician who is living with lymphedema.2 I would refer the authors to the article by Scalzitti,4 which defines and differentiates systematic reviews and clinical practice guidelines.
The third concern raised by Levinson et al is that a "disservice" was done to lymphedema therapists and their patients through the publication of this article. In my experience as both a physical therapist and a recent health care consumer, evidence-based practice goes hand in hand with patient-centered care. To suggest that basing practice on recent and peer-reviewed scientific evidence, in the form of a systematic review and clinical practice guidelines, does a "disservice" to patients with lymphedema is a very frightening statement to be made by a group of health care professionals.
I owe the past 4 years of my life to the fact that my own oncologists were evidence-based practitioners. My cancer treatments (chemotherapy and radiation) were based on the best scientific evidence available (level I randomized controlled trials) published in well-respected, peer-reviewed journals (ie, Journal of Clinical Oncology and New England Journal of Medicine).
I urge Levinson and colleagues to contribute to the limited body of knowledge on management of lymphedema by producing case reports or single-subject research reports on some of their patients and submitting their results to a peer-reviewed journal.
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Director
Pacific Therapy Education Inc
PO Box 892752
Temecula, CA 92589-2752
To the Editor:
In his March 2002 "Evidence in Practice" (EiP) article, the author had "decided to search for articles that document the effectiveness of comprehensive lymphedema management programs." After reading the article, I did not find any experimental evidence that supports the effectiveness of the program that he selected. Changes in girth measurements do not prove that the technique that was used has improved the lymphedema. To state that a technique has improved the lymphedema, one would need to examine the fundamental research conducted by the Bourgeois-Leduc team in Belgium1,2 or by Jean Claude Ferrandez and colleagues in France.3–5 In the field of lymphedema management, there is a search for evidence to support practice; we need to address this point in a thorough way.
Another point that I would like to make is that the literature search should not be restricted to one language as was the case in Megens and Harris,6 one of the articles cited in the EiP article. At the beginning of their "Method" section, Megens and Harris report, "Because we are fluent in English only, the literature search was restricted to English publications...."6(p1304) In the EiP article, the author's exclusive use of the English language obviously reduced his chances of carrying out a complete literature review.
Furthermore, when the author describes his clinical decision, he does not mention whether he is trained in the techniques that he decides to use. If he had not been previously trained in these techniques, this is certainly also a point of concern. I believe the scientific method should not be limited to a theoretical approach to the subject but should also include practical training.
In his description of his clinical decision, the author says, "I decided to implement a comprehensive regimen that included massage...." His use of the term "massage," however, is misleading. The manual technique used in lymphedema management is manual lymph drainage.7
Moreover, Ciccone is mistaken when he says, "Compression garments in reducing limb size in people with lymphedema...." A compression garment may reduce the size of an edematous limb, but not a lymphedematous limb. Compression garments maintain the reduction of lymphedema produced by using other techniques such as manual lymph drainage and multilayered bandaging. The Leduc team has demonstrated experimentally the effectiveness of the Leduc methods of both manual lymph drainage and multilayered bandaging.1,2
The author states that he will use "isometric exercises...to facilitate lymph drainage via the muscle pump." Leduc et al2 have demonstrated experimentally the ineffectiveness of isometric exercises on lymphatic flow. Isometric exercises enhance the lymph flow when performed on a limb with multilayered bandaging done according to the Leduc method and not when performed on a limb with compression bandaging.
The last paragraph of the EiP article says, "The issue of infection was never really addressed by the literature. I could not find any information that directly supported the use of physical therapy as a means to reduce the incidence of infection in people with lymphedema." If he had searched the literature using the following search terms for infection of the lymphatic system—dermatolymphangioadenitis, cellulitis or lymphangitis—he would have found the direct answers to his questions.8,9
The author has shown a certain determination in seeking an answer to his clinical question. He would have certainly achieved his goal of finding scientifically proven evidence more completely if he had been able to extend his search to other languages. In any case, I do not believe that a theoretical approach to his question was sufficient. Such a clinical question must be answered by the clinical expert. Expertise implies evidence-based and research-based knowledge.
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Editor—Evidence in Practice and Reviews
Physical Therapy
I thank Levinson et al and Vaillant-Newman for the opportunity to elaborate on key aspects of the Journal's "Evidence in Practice" (EiP) series.
EiP articles are not meant to imply a standard of practice, and the interventions used do not necessarily represent "the" singular or optimal method for managing the patients described in the articles. The purpose of EiP is to illustrate the process of searching a specific database to obtain and apply the evidence from the literature covered by that database. Levinson et al note that a thorough examination and evaluation is essential. I agree—but I also must emphasize that, in EiP articles, some details about the patient's background and the examination and evaluation are purposely truncated to focus on the literature search.
Levinson et al and Vaillant-Newman indicated that certain citations were not retrieved by my search. As explained in the article, I selected CINAHL because I wanted to cover the allied health and nursing literature. Again, the purpose of EiP articles is to show clinicians how to retrieve evidence that will guide their management of specific types of patients. This citation retrieval process is not analogous to an exhaustive literature search on a given topic. There is undoubtedly published information that is not indexed in CINAHL and that might pertain to the management of this type of patient. This information, however, does clinicians little good if they cannot access or interpret the data.
For instance, I speak and read English only; an article written in another language, therefore, would not help me answer this clinical question. In addition, information appearing in certain sources will be inaccessible (and therefore cannot be evaluated) if these sources are not indexed in a commonly used database. Sources such as textbooks and conference proceedings (eg, the Proceedings of the XIIth Congress of the International Society of Lymphology, a publication in which, Vaillant-Newman claims, Leduc et al demonstrate the effectiveness of their techniques) are not indexed in either CINAHL or MEDLINE.
Levinson et al are concerned that I did not select a regimen that they call complex physical therapy (CPT). I avoided using the term CPT in my clinical decision because that term tells us nothing about the actual interventions administered to the patient. Instead, I described the components of a regimen using terms that can be universally understood by physical therapists (eg, massage rather than manual lymph drainage, compression bandaging rather than Foldi technique). In fact, the regimen that I described includes all the components of what Levinson et al identify as CPT. Hence, it seems that our approaches differ primarily in the terms used to describe each component.
Most importantly, EiP emphasizes selecting interventions based on evidence obtained from the literature. The articles I retrieved in this case were published in peer-reviewed journals, they involved patients that were similar to my patient, and they described the interventions with sufficient detail that a physical therapist could replicate these interventions. The letter writers imply that their certification categorically enables a therapist to apply appropriate and skillful treatment and that anyone who is not certified is automatically unskilled. This type of insular thinking does little to advance the profession of physical therapy. I found no evidence to suggest that special training was required to apply these interventions or that outcomes were substantially better when patients were treated by therapists with advanced training. Moreover, it would be impossible to determine the skillfulness of an intervention without observing its application.
Finally, Levinson et al present references that they claim support the use of the regimen described as CPT. Vaillant-Newman also presents references to support the effectiveness of manual lymph drainage and multilayered bandaging and the ineffectiveness of isometric exercises. Neither Levinson et al nor Vaillant-Newman indicated exactly how these studies established evidence for the effectiveness or ineffectivness of the interventions they discuss. For example, which studies used randomized well-controlled trials with sufficient statistical power to prove conclusively that the regimen they advocate is the optimal treatment for the type of patient described in the EiP article? As clinicians, we would need this information to fully assess the claims of Levinson et al and Vaillant-Newman.
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Physical Therapy 2002 82: 276-282.
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