Добавил:
kiopkiopkiop18@yandex.ru t.me/Prokururor I Вовсе не секретарь, но почту проверяю Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз: Предмет: Файл:
Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3798_Библиотеки_им_академика_М_И_Перельмана.pdf
Скачиваний:
1
Добавлен:
15.09.2026
Размер:
17 Мб
Скачать
☆
14 Early Diagnosis in Latent Phase
11. Lette J. A simple and innovative device to measure arm volume at home for patients with
lymphedema after breast cancer. J Clin Oncol. 2006;24:5434-5440.
12. Taylor R, Jayasinghe UW, Koelmeyer L, Ung O, Boyages J. Reliability and validity of arm
volume measurements for assessment of lymphedema. Phys Ther. 2006;86:205-214.
13. Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, et al. Reliability and limits of
agreement of circumferential, water displacement, and optoelectronic volumetry in the mea­surement of upper limb lymphedema. Lymphology. 2007;40:26-34.
14. Box RC, Reul-Hirche HM, Bullock-Saxton JE, Furnival CM. Physiotherapy after breast can-
cer surgery: results of a randomised controlled study to minimise lymphoedema. Breast Cancer Res Treat. 2002;75:51-64.
15. Hayes S, Cornish B, Newman B. Comparison of methods to diagnose lymphoedema among
breast cancer survivors: 6-month follow-up. Breast Cancer Res Treat. 2005;89:221-226.
16. Cornish BH, Chapman M, Hirst C, Mirolo B, Bunce IH, et al. Early diagnosis of lymphedema
using multiple frequency bioimpedance. Lymphology. 2001;34:2-11.
17. Ward LC, Kilbreath SL, Cornish BH. Bioelectrical impedance analysis for early detection of
lymphoedema. In: Weissleder H, Schuchhardt C, eds. Lymphedema Diagnosis and Therapy. 4th ed. Essen: Viavital Verlag Gmbh Publ; 2008:502-517:chap 15.
18. Ridner SH, Dietrich MS, Deng J, Bonner CM, Kidd N. Bioelectrical impedance for detecting
upper limb lymphedema in non laboratory settings. Lymphat Res Biol. 2009;7:11-15.
109
Chapter 15
Review of National and International Consensuses on Chronic Lymphedema
Michael J. Bernas

Consensus Documents

Consensus documents are produced in an effort to help move a field forward and/or to offer to patients the best evidence/expert-based treatment approaches. The results can be positive, by promoting clearly beneficial options in the face of multiple choices, but they can also be harmful by limiting therapeutic options and stifling research for future advances. Some physicians, policy-makers, and patients desire documents with clear unalterable protocols, whereas an equal cohort exists that believe that these documents confine and distort the practice of medicine. An inher­ent problem that will not easily be resolved is that these types of guidelines are based on studies of populations of patients and generate protocols appropriate for a range of patients. However, each patient brings his or her own individual constella­tion of issues and findings, rendering it impossible for a consensus to address each item. Therefore, sound clinical judgment and modification will always be required.
A pitfall of consensus or guideline documents is the delays involved in generat­ing the documents and the rapidity of changes in the field (particularly when based on imperfect data). An analysis of large systematic reviews has shown that there is a need for frequent updating. A recent study evaluating 100 systematic reviews (a median of 13 studies with 2,633 participants each) demonstrated indications for updating of 15% in 1 year and 23% within 2 years with a median change-free sur­vival of 5.5 years for all studies.1 Supporting this are groups like the American College of Physicians, with strong rules for clinical practice guidelines, such as any guidelines that are not updated within 5 years are considered invalid and are withdrawn.2 The type and quality of evidence can also be problematic in consen­sus or guideline documents. A recent large study from the American College of
M.J. Bernas Department of Surgery, University of Arizona College of Medicine, Tucson, AZ, USA
B.-B. Lee et al. (eds.), Lymphedema, DOI 10.1007/978-0-85729-567-5_15, © Springer-Verlag London Limited 2011
111
112 M.J. Bernas
Cardiology and American Heart Association, reviewing practice guidelines from 1984 to 2008, demonstrated that only 11% of the studies reported levels of evidence noted as level A (the highest), and of those documents with revision or update by 2008, there was a 48% increase in the number of recommendations.
3
An additional problem is the lack of appropriate and well-designed studies. What if there is no, or very limited, high-quality evidence upon which to base these clini­cal decisions? Because no trial can answer all possible questions about a treatment, different experts will interpret trial results differently, and it soon becomes clear that the “evidence” is subject to “opinion.”4 The challenge is how to move beyond poor evidence-based data and opinion-based data to treating the patients in the real world. Finally, conflict of interest and expert commercial/promotional bias in the develop­ment of the specific guidelines is an increasingly troublesome problem. Some groups, such as the American College of Physicians, have very clear and detailed rules to avoid conflict and bias,2 but this is lacking in many of the consensus or guideline documents.

Consensus Documents in the Treatment of Lymphedema

Because there are no definitive studies that have been published concerning the best treatment for patients with lymphedema, we are left with an ever-growing collection of studies with lower levels of evidence. These, combined with expert opinions, largely shape the consensus documents that have been produced.
Just as in clinical medicine, where every treatment must be evaluated on a cost– benefit ratio, consensus documents concerning lymphedema must undergo cost­benefit analysis. They can be beneficial in setting minimum standards, gathering and analyzing multiple and disparate research studies to produce treatment justifica­tion, and for education of providers, payers, and consumers. But they can also be harmful by stifling innovative research into new treatments and promoting defen­sive medicine, as well as creating the danger of treating patients by population­based care instead of individualized, personal care.
No double-blind controls for the physical treatments for lymphedema exist or may even be possible. Some blinding can be used for measurement personnel, but blinding of the therapist or, in most cases, of the patient, to the treatment is not fea­sible or possible. The field also reflects a theme common to many other clinical trials, in that the methods are tested against nothing or a placebo, and only rarely against a well-recognized, accepted standard. It is likely that such trials will never be completed because of logistical considerations and also lack of funding to sup­port head-to-head trials of multiple currently used therapies. Despite the existence of some clinics that have treated thousands or even tens of thousands of patients over years, we have no published studies of this magnitude that would lend consid­erable weight regarding evaluation of methods.
We are left with informative, but inadequate data ranging from small pilot trials to larger trials that suffer from some design defects. This lack of strong
15 Review of National and International Consensuses on Chronic Lymphedema
113
evidence-based information has led us to search and pursue meta-analyses for answers (realizing that the underlying studies are inadequate), in an attempt to avoid opinion-based medicine. Unfortunately, in the field of treatment for lym­phedema, we have not yet advanced to this level, and we still need to rely on the opinions of experts from around the globe. Therefore, the best documents are those that are generated by wide-reaching groups of experienced clinicians and researchers who frequently meet to review, argue, and revise their consensus opinions (mindful of conflict or bias issues) with the understanding that these guidelines are provided as the best ideas on how to treat and move forward despite the limitations in the field and the specific context of the patient.

International Society of Lymphology

The first document to examine is by far the oldest, and also has the most recent update: the Consensus Document on the Diagnosis and Treatment of Peripheral Lymphedema of the International Society of Lymphology.5 This document repre­sents the centerpiece of current views on diagnosis and treatment of peripheral lym­phedema from the broad international perspective of leading lymphologists from the 42 nations represented by the members of the International Society of Lymphology (ISL). It has been extensively cited and used throughout the world, and it is broad in scope reflective of the ISL membership, their national origins, and also the variety of patients with lymphedema.
The document coalesced from an initial thesis prepared by Professors Michael and Etelka Földi and developed into a working document at the 1994 ISL Executive Committee meeting at the Földiklinik in Hinterzarten, Germany. Following several rounds of reviews/criticisms/edits by Executive Committee members and other ISL experts, it was developed for international publication in 1995.6 It has been debated openly at each biennial International Congress of Lymphology meetings since, at regional and national ISL affiliate meetings and openly at Executive Committee Meetings from 2000 to 2010, resulting in major published revisions in 2001, 2003, and most recently, in 2009.5 Thus, the ISL Consensus Document reflects the evolv­ing global consensus underlying the theory and practice of lymphology, highlight­ing diagnosis and assessment, a wide range of treatments, and acknowledging and promoting areas of research and exploring uncertainties and unknowns, from which future advances will emerge. The document does list and briefly explain many therapeutic techniques utilized worldwide by multi-specialty physicians and other health care providers and proposes that in the optimal setting the combination of skin care, manual lymph drainage, compression bandaging, garments, and exercise is a strongly supported multi-modal choice. This regimen is noted as CPT-combined physiotherapy, but it is also known by related names such as complete or complex physiotherapy (CPT), complex decongestive therapy (CDT), complex deconges­tive physiotherapy (CDPT), lymphatic therapy (LT), or decongestive lymphatic therapy (DLT) among others.
114 M.J. Bernas
The ISL document is a useful tool and not a set of strict protocols, algorithms, or best practice mandates with exhaustive references or meta-analyses. Such an approach would rigidly define the boundaries of quality care for specific forms or location of lymphedema without consideration of complicating features or complex syndromes and local practice conditions. This document is not perfect or ideal, but it strives to be inclusive of ISL members worldwide and looks to the future to improve assessment by combining imaging and physical examination for phenotyp­ing; incorporate the genetic and psychosocial context of the patients; recognize and appreciate many available therapeutic options including those that may be country-/ region-/resource-specific; and promote a research agenda to advance understanding, diagnosis, and treatment. Special features of this document are the recognition and statement of the need for more epidemiological studies of incidence, prevalence, and risk factors; encouragement of database registries; promotion of studies on pre­vention; the advancement of imaging technologies; and the promise of molecular lymphology and genomic/proteomic studies.

International Lymphedema Framework

The International Lymphedema Framework published their Best Practice guide­lines in 20067 as the culmination of a multi-year process in the United Kingdom (UK). The document was generated by UK clinicians, therapists, researchers, industry, and patient participants and was reviewed and/or endorsed by a wide international group of experts and Societies. It is written rather as a guideline for care in a clinical setting with added depth because of a diligent research review and is also valuable for policy review in those countries that have health care sys­tems that match the UK model. Its strength is found in the extensive literature review and grading of evidence for treatment modalities, the inclusion of refer­ences culled from a growing volume of literature, and detailed illustrations and flowcharts that may be useful in the clinic for quick reference or for policy makers for quick study. The document confirms the lack of substantial published data for many of the treatment modalities and the great need for more investigations with none of the recommendations reaching their level A (clear research evidence) support and most being noted as limited supporting research (level B) or experi­enced common sense judgment (level C). The framers envision that the document will be updated approximately every 5 years, and such efforts are currently under­way with affiliated groups such as the American Lymphedema Framework. What these changes will bring about is unclear at this point, since each country will have a different focus to bring to the Framework. As an example, the original document described the manual massage and compression as separate treatment modalities while in the United States and many other places around the world (e.g., Germany) the most recommended treatment (as also supported by the ISL Consensus Document) is the combination of the manual massage and compression bandag­ing (i.e., CPT).
15 Review of National and International Consensuses on Chronic Lymphedema
115

Italian

The guidelines from the Italian Society were published in 20048 following an open session at the University Master Course on the guidelines for the diagnosis and treatment of lymphedema in Genoa, Italy. The group consisted of primarily Italian physicians and healthcare professionals and also patients and a few international guests from Belgium and Korea. The guidelines have not yet been updated, and they are patterned after the ISL document with customization for the Italian Society. The guidelines are, therefore, similar to the ISL with 143 references added and recom­mendations for each section. The document describes CPT along with other treat­ment modalities (i.e., pneumatic compression and pharmacology). Here also, the lack of optimal studies is documented with only the diagnostic imaging section recommended as Level A evidence. The guidelines do include additional data con­cerning angiodysplasias and neonatal lymphatic dysplasias along with an expanded section on surgical treatments.

Latin American

The Latin American Consensus on the Management of Lymphedema was published in 2004 following a meeting in March 2003 in Buenos Aires specifically for the development of a consensus. Over 30 clinical experts from Latin America were in attendance, with the document undergoing final editing by J. Ciucci.9 It has not been updated. The document is similar to the ISL document in that it does not include references or recommendations, but it does not have the same depth and is not as all-encompassing. As with the Framework document, it also does not link massage and bandaging into the more commonly accepted CPT. It includes strongly written sections on pneumatic compression and pharmacotherapy that are uniquely reflec­tive of the Latin American consensus and also has valuable sections on multidisci­plinary treatment and psychotherapy.

Australian

This document is the result of committee meetings designed to provide the govern­ment with a review of the current practices and the near future in Australia. Collected from data up to 2004, it was finalized and approved in 2005 and published in 2006.10 It includes a detailed literature review with a wide breadth of the field including diagnosis and assessment as well as treatment options. The substantial document tends to appear overly bureaucratic, at 105 pages in length with references included. It reports that there are no Australian standards established for the treatment and reaffirms the lack of high-quality evidence or randomized controlled trials for
116 M.J. Bernas
supporting treatments. However, it does state that there is reasonable evidence to indicate that early, accurate diagnosis followed by the routine use of prescription compression garments and physical therapy can provide short-term improvements. It further describes CPT as having favorable outcomes, but that evidence from trials is inconsistent and additional data are required to define an optimal strategy.

American Cancer Society

The American Cancer Society supported a Lymphedema Workshop in 1998 focus­ing on breast cancer treatment-related lymphedema. One of the workgroups focused on the diagnosis and management of lymphedema and produced a document result­ing from the workgroup.11 It was a review of current opinions of experts at the meet­ing that is now somewhat dated and only focused on breast cancer-related lymphedema. It has not been updated. The workshop addressed the issue of treat­ment and supported the view that CPT is the best approach for treatment. It also mentions the issue of the various names for this treatment and suggests a more uni­versal “decongestive lymphatic therapy” for the future. It is interesting that, despite both this and the ISL document being published early, subsequent documents have failed to combine the massage and bandaging as CPT.

National Lymphedema Network

The National Lymphedema Network based in the United States has published a series of position papers concerning various aspects of lymphedema. One such paper concerns treatment of lymphedema,12 is produced by the Medical Advisory Committee of the organization, and has undergone revision with the current version of the document last approved in August 2006. It does include references and is without recommendations. The document is more reflective of the treatment options in the United States and is focused and concise enough to be appropriate for multi­ple users. The treatment focus is on CPT, which it covers well, and it does review primarily the precautions related to pneumatic compression, surgical treatments, and pharmaceutical options.

Summary

In the field of treatment for lymphedema, these multiple documents serve as proof that there does not yet exist a comprehensive treatment approach for all patients in all nations (and that likely none will ever exist). There is also clearly a need for large-scale trials and for those to compare multiple treatments (and combinations).
15 Review of National and International Consensuses on Chronic Lymphedema
117
Until these studies are completed or until some large patient series is published, the field will struggle for solid evidence. Diligence will be needed to confront efforts to lump all relevant, but poorly randomized controlled trials into one all-encompassing database for which multiple metanalyses will be run to determine the best odds ratios for treatments. The field is striving to achieve the goal of evidence-based medicine (despite the caveats of its danger) in order to offer the best treatment to our patients while at the same time being aware of pitfalls such as Eminence-based medicine (opinions of senior physicians, which can sometimes be a substitute for evidence) or Vehemence-based medicine (where the substitution of volume for evi- dence clouds the issues).
13

Concluding Thought

This is how doctors and patients make shared decisions − by considering expert guidelines,
weighing why other experts may disagree with the guidelines, and then customizing the
therapy to the individual. With respect to “best practices,” prudent doctors think, not just
follow, and informed patients consider and then choose, not just comply.
Jerome Groopman and Pamela Hartzband
14

Disclosure

The Author is the Executive Editor of the journal Lymphology. He has been a mem- ber of the Executive Committee of the International Society of Lymphology, and functions as the point person responsible for collecting criticisms, comments, and suggestions for editing into revisions of the Society’s Consensus Document. He is also a member of the American Lymphedema Framework Project and the National Lymphedema Network.

References

1. Shojania KG, Sampson M, Ansari MT, Ji J, Doucette S, Moher D. How quickly do systematic
reviews go out of date? A survival analysis. Ann Intern Med. 2007;147:224-233.
2. Qaseem A, Snow V, Owens DK, Shekelle P. The development of clinical practice guidelines
and guidance statements of the American College of Physicians: summary of methods. Ann Intern Med. 2010;153:194-199.
3. Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC. Scientific evidence underlying the
ACC/AHA clinical practice guidelines. JAMA. 2009;301:831-841.
4. Hampton JR. Evidence-based medicine, opinion-based medicine, and real-world medicine.
Perspect Biol Med. 2002;45:549-568.
5. International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema:
2009 consensus document. Lymphology. 2009;42(2):51-60.
118 M.J. Bernas
6. International Society of Lymphology Executive Committee. The diagnosis and treatment of
peripheral lymphedema. Lymphology. 1995;28:113-117.
7. International Lymphoedema Framework Project. Best Practice for the Management of
Lymphoedema: International Consensus. London: Medical Education Partnership Ltd; 2006.
8. Campisi C, Michelini S, Boccardo F. Guidelines of the societá italiana di linfangiologia.
Lymphology. 2004;37:165-184.
9. Ciucci JL. 1st Latin American consensus on the management of lymphedema. Phlebolymphology.
2004;44:258-264.
10. Australian Health Ministers’ Advisory Council Report. A review of current practices and
future directions in the diagnosis, prevention and treatment of lymphoedema in Australia 2006. Available at: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/Review+of+lymp
hoedema+in+Australia accessed 05/11/2011.
11. Rockson SG, Miller LT, Senie R, et al. American Cancer Society lymphedema workshop.
Workgroup III: diagnosis and management of lymphedema. Cancer. 1998;83(12):2882-2885.
12. National Lymphedema Network Medical Advisory Committee. Position statement of the treat-
ment of lymphedema [document on the Internet]. National Lymphedema Network; 2011 [updated 2011, February]. Available at: http://www.lymphnet.org/pdfDocs/nlntreatment.pdf accessed 05/11/2011.
13. Isaacs D, Fitzgerald D. Seven alternatives to evidence based medicine. BMJ. 1999;319:1618.
14. Groopman J, Hartzband P. Sorting fact from fiction on health care. The Wall Street Journal.
August 31, 2009. Available at: http://online.wsj.com/article/SB100014240529702037066045
74378542143891778.html accessed 05/11/2011.