Article attacks risk reduction and incidence of LE

So... the goal is to reduce the anxiety about developing LE.  The hell with reducing the risk of LE.

Yeah, that's a good idea.

Leah

I'm insulted, totally insulted.  In other works, "Don't Worry, Be Happy".  (Btw, I never did like that song.)

Outfield, thank you--beautifully said! Perhaps someone of worth will see it; you never know.

Agree with points made above. My first impression was: small numbers, no control group, only 1 year (when they reference 90% of cases developing up to 3 years out - are they continuing to follow?) and, most importantly, written by a SURGEON probably in denial about the damage she causes! LE is mentioned as an incurable condition but also as "painless" which is simply not true. 

Medical literature, along with social science & psychology as well as other fields, is riddled with studies that do not make any attempt to neutralize investigation bias. In other words, conclusions are formed before the work begins and the data is manipulated to fit. Often, the researcher is unaware of their own underlying assumptions. That is why peer review and replication are so critical. If others cannot reproduce the results, the whole thing is called into question.

I thought Mayo people would adhere to higher standards...  

Here is the email I sent this evening. It's long, because I had a lot to say.

Dear Dr. McLaughlin:

While reading your article, Trends in Risk Reduction Practices for the Prevention of Lymphedema in the First 12 Months after Breast Cancer Surgery, a few points in the study description and discussion caught my attention. I have breast cancer-related lymphedema; my treatment consisted of bilateral mastectomy and sentinel node biopsy. I was not given any pre-surgical lymphedema measures, risk counseling, or risk-reduction education. I find many of your article’s points and conclusions to be disturbing, and in this letter I shall attempt to explain why.

You make the point that studies disagree on which risk factors are significant and they present contradictory data concerning the influence of each risk factor on the future development of lymphedema.  This is precisely why the pendulum of doubt must swing to the side of risk-reduction behaviors. When in doubt, err to the side of caution.

Your study goes on to say that because risk factors are inconsistent, clinicians educate all breast cancer survivors on precautionary behaviors in an effort to reduce patient risk for lymphedema.  If only that were true!  Lymphedema risk counseling and related education on precautionary measures is inconsistent at best. Please do not confuse the lymphedema education / breast-cancer intake process at the Mayo Clinic with process at large. Speaking as a woman with BCRL who networks with many other BCRL patients, it is our experience that outside of major cancer centers, lymphedema often is discussed only if the breast cancer patient specifically asks about her risk.

You explain that the National Lymphedema Network acknowledges the paucity of high quality evidence supporting these practices and admits recommendations are based on expert opinion and physiologic principles. It would be unethical to enroll breast cancer patients and survivors in a study in which they are asked to burn, poke, or cut their arms, or to fly twenty hours weekly, to answer the question of injury’s role in provoking lymphedema in an at-risk arm. Therefore, ‘a paucity of evidence’ is the body of knowledge from which we are obligated to infer lymphedema risk, and that is precisely why we seek expert opinion to interpret physiologic principles and suggest common-sense precautionary behaviors. How is it helpful to dismiss the role of expert opinion?

You have hypothesized that…despite the lack of evidence supporting precautionary behaviors to avoid lymphedema development, the majority of women fear lymphedema and, therefore, will follow risk reduction practices. Dr. McLaughlin, the most honest statement in your article is that women fear lymphedema. Indeed we do. What enables a woman to engage in medicine’s draconian assaults against cancer? It is her confidence in research and in the science of breast cancer treatment. Breast cancer research has been funded with mega dollars over many decades, but of course, the same cannot be said about lymphedema research. Which should I fear most: arguably the most studied disease that might afflict the human body, or a lesser-known condition whose cause, let alone cure, is not well understood? We fear lymphedema precisely because of the lack of evidence to support solid risk assessment and risk-avoidance strategies. No one really knows the extent to which the standard risk-reduction behaviors reduce our risk of lymphedema or its sequelae, because random controlled-trial risk-reduction studies would in fact be unethical research. We are obligated to make our risk-reduction decisions in the murky environment of uncertainty; is uncertainty an argument against taking precautions? I think not, especially considering the stakes: Lymphedema is forever, and once we have it, there are no do-overs, no second chances to take the discarded precautions. We do fear lymphedema so yes…we will follow risk reduction practices.

I leave to lymphedema clinicians, educators and researchers the task of questioning some of your study design choices, such as using a ten percent diagnostic criterion for lymphedema (which is a very high bar and may well explain why, interestingly, at all time points and regardless of the type of axillary surgery, more patients perceived swelling than had measured lymphedema. I find it stunning that your study finds that at 12 months, we found extent of axillary surgery to be the only significant risk for developing lymphedema. BMI at the time of surgery, and radiation, are well documented risks for lymphedema. That your study did not identify these risks raises a very serious question of study design, including the apparent dismissal of latent, or stage 0 lymphedema as worthy of risk correlation.

Finally, your study participants practiced risk reducing behaviors throughout the study. Is it possible that your very low documented lymphedema incidence is in fact, the product of the risk reduction decisions made not out of fear, but in considered response to the lymphedema education provided at the time of breast cancer intake?

Dr. McLaughlin, you seem to be advocating for an end to the general application of precautionary behaviors to all breast cancer patients, on the grounds that there exists persisting patient and clinician confusion. In my view, the only persisting confusion is why any clinician would deny a woman information and the choice of whether to adopt risk-reduction strategies, based on a misguided goal of reducing fear through the application of ignorance.

Sincerely,

I can't tell if that study made me more angry or depressed. I doubt that my letter will have any impact, but I have great, great hopes that the various LE organizations Kira sent the study to will indeed respond and be taken seriously.  My arm hurts today. I was given zero heads-up or education on LE risk and precautions.  Would those have made a difference?  Maybe, but I'll never know, of course. It's so incredibly sad to think that I missed my chance at a 'maybe' and that there are so-called researchers who think that's appropriate. Usually I can keep a glass-half-full outlook even about LE, but to think that someone who has a platform is actually arguing in favor of keeping us in the dark? It's beyond my ability to comprehend.

Carol

Thanks so much for a detailed, well written and articulate letter!
Right now, all I can say is grrrr!

Dr. McLaughlin sent me a very kind and respectful response to my email. In her note, she said that my comments " are meaningful especially from the perspective of an affected survivor. I will review them and take them into account in my future works." Dr. McLaughlin sent me some studies to review, and she ended by asking me to "please remember that part of the problem in diagnosing lymphedema is the lack of standardized definitions and assessment criteria for evaluation."  I certainly agree with that last point!

I'm pretty sure that she remains unconvinced that risk-reduction practices are justifiable based on evidence from research, but I  remain hopeful that she might consider our need for information -- and we should be reminded that the evidence is, in fact, often weak--so we can make our own decision regarding whether to follow the traditional risk-reduction advice or not.

The Journal acknowledged my email, and in fact I received a very nice note from the managing editor. My letter is to be forwarded on to the editor-in-chief, but as I'm not a clinician, I doubt very much that the Journal will publish my rebuttal to Dr. McLaughlin's study. Which is a shame, because although I disagree with her interpretations, Dr. McLaughlin makes some valid points about research limitations, and we should be having a lymphedema-community-wide discussion of what the weak evidence for risk-reduction behavior means for us in real life.  A rebuttal letter or editorial in the Journal might prompt that kind of discussion.

As for me, I will continue to avoid BPs and needle sticks in my LE arm; I won't be hopping into a sauna; and I'll be slathering sunscreen and insect repellent with the best of them this summer. I already have LE, so my risk-reduction behavior is aimed at keeping it in its current mild state and avoiding infection.  If I didn't have LE, I would be doing exactly the same thing.  But that's just my personal, non-clinical take on 'the evidence.'

Purple, that's a great email you sent!  You made some wonderful points.  I sent my email to the journal, as well, so I think the same editor will see yours.  If you receive no response, it could be that she's overwhelmed with letters--wouldn't that be great?

That reminds me of my mother who proposed that if I did not wear my sleeve, I would not have a LE problem, because then I wouldn't be reminded of it ... It is all in your head, you see. Meanwhile, she has LE herself due to surgery for ovarian cancer (LE in the leg).

I will write - thank you!   I just had a MAJOR FLARE up of Lymphedema

because I lifted 3 grocery bags....