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Do Cesareans Cause Endometriosis (Redux): What could patient-driven research look like?

October 11th, 2010 by avatar

This post is part of the forthcoming Grand Rounds Blog Carnival at e-patients.net. Contributors were asked to write a post “inspired by, supportive of, or critiquing an article in the Journal of Participatory Medicine.” I chose as my inspiration Gilles Frydman’s Patient-Driven Research: Rich Opportunities and Real Risks.

When I started this blog a year and a half ago, my primary motivation was my belief that childbearing women deserved, above nearly all else, care that was “evidence-based.”  As I prepare to hand over the reins to a new Community Manager, I want to say to my readers and to my successor: I was wrong. Evidence doesn’t hold all of the answers.

There are many reasons I have come to believe this, but there are two I want to write about today. The first is that the way research is currently funded, conducted, and disseminated, it simply doesn’t address many outcomes that women care about.  The second is that we all arrive at the point of healthcare decision making with a different constellation of factors that affect our choices. We may have different financial resources, health situations, hopes and plans for the future, tolerance to pain, tolerance to risk, prior experiences, and so on.

In other words, with the exception of practices that cause harm with no counterbalancing benefit at all or benefit with no risk of harm at all, there is no such thing as a good or bad healthcare decision. There’s only such a thing as a good or bad healthcare decision for a certain person. Evidence cannot guide practice without the other piece of the equation – the person to which the evidence is to be applied.

The more I think and write about these issues, the more I begin to wonder if there’s a better way of creating and disseminating knowledge than evidence-as-we-know-it. Underscoring this is a phenomenon that has unfolded over the past year right here on this blog.  In May 2009, Science & Sensibility contributor, Henci Goer, presented the findings of her review of the literature on cesarean surgery and a little-known complication: new onset endometriosis.  She wrote:

So why is this reasonably common serious adverse effect of cesarean surgery something you have never heard of?…Cesarean wound endometriosis would never turn up in a randomized controlled trial (RCT). Even if the problem made it onto the researchers’ radar, the trial would have to be extremely large and follow-up impractically long to detect it. Where RCTs are considered the only evidence worth having, outcomes that cannot be picked up on by RCTs functionally don’t exist.

It was kind of a technical post about the limitations of the hierarchy of evidence, using cesareans and endometriosis as the example. But an awesome thing happened. Women started finding the blog post, and sharing their own experiences with sometimes terribly debilitating endometriosis after cesarean surgery. It started with a well known cesarean activist confirming that the association between cesareans and endometriosis was “not news” to her – through her work she had met many cesarean mothers dealing with cesarean scar endometriosis. Then women who had experienced it themselves shared their insights, and asked questions, and others answered, and they got interested in eachother’s experiences and a community formed.

I highly recommend you read the original post and all of the comments, but you can also get a flavor by looking at this excerpt of the presentation I will give next week at the Digital Pharma East Conference in Philadelphia.

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  1. avatar
    Meg Freebern
    October 11th, 2010 at 13:34 | #1

    This post puts good words behind what I feel was inadequate care following my pregnancy complication. I developed two very severe blood clots (deep vein thrombosis or DVT) at 29 weeks into my first pregnancy. After I started to recover and my chance of death from pulmonary embolism reduced, I started to ask my hematologist what this meant for future pregnancies and the rest of my life. She would say things like, “Well, you had two pretty sever clots” and “The valves in your iliac vein are likely to be damaged” and “You know, those were pretty severe clots.” I couldn’t get out of her what that would MEAN for me. Is this going to cause early death? How much pain will I have in my legs as I age? How will this affect my physical abilities? How swollen and veiny will my legs be? “Oh, well, you know … those were pretty severe clots.” This is not just a medical issue but a story that be lived out long after I stop seeing that hematologist.

  2. October 11th, 2010 at 20:11 | #2

    Very well put! The potential for research, including “non-standard” methods is immense. While we know some about childbirth, and health in general, there is much more to be investigated. I am fascinated and excited by the potential for discovery, but also find the limitations of traditional research frustrating.

  3. October 11th, 2010 at 20:18 | #3

    I’ll be honest, Amy. I cringed a little when I read the phrase “Evidence doesn’t hold all of the answers.”

    But of course, as I read through your article and considered my experience as a clinician I saw that your point which initially had the ring of scientific apostasy was actually well grounded in reality and common sense.

    You properly state the fact that different individuals faced with the same data will make drastically different decisions based on personal characteristics not accounted for in the research. Thus in the field of women’s health the individual is left with great studies which (in the end) do not speak to their particular concerns.

    This is not a reason to discard the evidence; rather it is a reason to have other tools available to address the individual concerns of patients and place the available studies in context for any given person.

    The idea of social media and online resources to achieve personalized medicine is similar to the idea of the “Long Tail” of niche marketing popularized by Chris Anderson in his book of the same name. However, rather than “selling a large number of unique items in relatively small quantities”, social media allows large numbers of diverse individuals to congregate and obtain specific information in vast quantities. Thereby providing individualized, interactive, specific, participatory data which could never be obtained from a research study while (at the same time) potentially enhancing existing research and providing context and perspective for further study.

    None of us know what social media and participatory medicine have in store for patients in general and women in particular; however, if the recent trends in disruption and innovation in old paradigms is any guide I suggest that we strap on our seatbelts and prepare for an exhilarating ride!

  4. October 11th, 2010 at 20:37 | #4

    Oh, man, what do I need to do to sneak into the conference next week to see you present this? I live a cat toss away from the city!

    I think about this all the time, or..mostly in the shower for some reason. I have such a love for the term “evidence based” and I want to wield it all over maternity care. And yet…my very introduction to working with other people’s bodies was through Reiki – a totally unproven, unprovable healing system that I fully and wholeheartedly believe in.

    When I was pg with my twins who had TTTS, the research I did was way less evidence-based (because unfortunately, there weren’t many answers — I was pregnant just as a major study was being done here @ CHOP, but I wasn’t down with being a participant) and way more patient-driven. I listened to the stories from other mothers who had gone before me, talked to the few folks in the country that specialize in the condition, and then chose nutrition over an invasive procedure as our first course of action. I also had to change practices to find one that respected our decision and our input; it was my first introduction to the idea that my pregnant body was no longer my own as far as others were concerned.

    Anyway.

    My husband works in marketing – for the past six months it’s been product based (cars), but before that it was all pharma with some of it focused in women’s reproductive health. Those folks? The ad agencies? Will totally and completely listen to patient stories and then present that to physicians because from their point of view, improving practice means listening to the patient. The patient needs to know, “hey, this doctor *really* gets ME!” Why is this not transferred over to maternity care? I would love to see what that would look like, too.

  5. October 12th, 2010 at 08:34 | #5

    You are SO awesome, Amy. Will be you presenting something on this topic at the ACNM Annual Meeting next May? I won’t be there to see it since I’ll be snuggling a newborn about that time, but I’d love to see your ideas reach more midwives.

    I’m in my first pregnancy and have relied heavily on research so far. However, some topics simply aren’t addressed in the research. When I feel a new sensation, I run straight to message boards to see what other women’s experiences have been.

  6. avatar
    Jennifer
    October 12th, 2010 at 11:04 | #6

    Great post Amy!

    “Evidence Based Practice” has become the word of gospel in hospitals all over the country, and while it’s a huge (and positive!) leap forward, that, along with the climate of fear that permeates all aspects of medicine these days, has led to a decline in individualized care. We are taught in midwifery school that every woman is different, as is every pregnancy and every bith with the same woman. We are taught to apply best practices on an individual level to fit each woman’s unique situation. However, in the harsh light of day, the institutionalization of maternity care has led to blanket application of guidelines as law, and not as *guidelines.* The culture of lawsuits has made providers of women’s health care say: ‘I did what the evidence says is best. I am absolved.’It is very hard to find a provider who will stand up and say, ‘the guidelines recommend X, but for this woman, Y is really the most appropriate cause of action (or inaction).’

    The thought of patient-driven maternity research is really encouraging, but as we learned this summer from Eugene DeClerc: There can’t be a revolution if the women are happy with the status-quo, and what we really need is a revolution.

  7. avatar
    Katie
    October 12th, 2010 at 16:12 | #7

    Yes Jennifer! We absolutely need a birth revolution!

  8. October 12th, 2010 at 16:50 | #8

    PatientsLikeMe is a social media and networking site providing data for research purposes as well as being used for participatory motivations.

  9. October 12th, 2010 at 19:20 | #9

    Thanks for all the wonderful comments, everyone!

    Chukwuma Onyeije, M.D. :
    Thus in the field of women’s health the individual is left with great studies which (in the end) do not speak to their particular concerns.

    This is not a reason to discard the evidence; rather it is a reason to have other tools available to address the individual concerns of patients and place the available studies in context for any given person.

    I couldn’t agree more. I don’t want to disparage maternity care research as a whole – there is plenty of good research, along with a good deal of bad research. But even if it was all perfectly well executed, it has its limitations. I think new forms of evidence are inevitable as we march into the Web 2.0 era and beyond – what is the participatory internet if not a vast sea of qualitative and increasingly quantitative data? I know it will require a different set of tools and rules, but I also think we should make it a priority to begin establishing those tools and rules, so that we can get on with things and improve care and, more importantly, health.

    Other thoughts:
    1. I’m definitely going to have to read the Long Tail
    2. @FoxyKate – If I was planning on overnighting in Philly, I’d say we should get coffee. Maybe next time – I used to live and work in Wilmington and try to get back to visit friends. Also, it’s interesting that you say pharma marketing folks want to improve health and are patient-focused. I think I had that crowd pretty well stereotyped in my mind and this will be the first time I speak at this kind of event. It’s good to know they’ll be receptive to what I have to say. There’s so much need for women to have better data about the effects – therapeutic and unintended – of pharmaceutical products, and doing more clinical safety and effectiveness trials in pregnant women is fraught with ethical issues. Harnessing the participatory internet and gathering data from patients themselves has huge potential.
    3. YES on the birth revolution – that’s what I’ve pretty much devoted my life to.
    4. @Dallas Knight – I’m familiar with PatientsLikeMe and linked to one of the studies of PLM from the post. I’d LOVE to see a maternity care adaptation of PLM to collect data on longer term effects of different behaviors and maternity care practices. It’s kind of what pregnancy.wisertogether.com is doing. I’d love their take on this post. (Already DM’ed them on Twiter…)

    Thanks again for all the great discussion!

  10. October 12th, 2010 at 20:59 | #10

    @Melissa
    Melissa – thanks for your comment. I didn’t submit an abstract for San Antonio. I plan to take a year off and then hopefully attend and speak at 2012. I hope I’ll have much more to report by then!

  11. October 13th, 2010 at 22:52 | #11

    Amy – I agree that evidence doesn’t hold the answers to everything, but not with Henci’s statement, or her conclusions.

    “So why is this reasonably common serious adverse effect of cesarean surgery something you have never heard of?…Cesarean wound endometriosis would never turn up in a randomized controlled trial (RCT). Even if the problem made it onto the researchers’ radar, the trial would have to be extremely large and follow-up impractically long to detect it. Where RCTs are considered the only evidence worth having, outcomes that cannot be picked up on by RCTs functionally don’t exist.”

    The reality is that the reason that this somewhat uncommon complication of a cesarean has not been heard of is not because of RCTs, its because most people are not experts in the field. Any decent OB/GYN has heard of this, not because of evidence or lack thereof, but because of experience. No one would care about doing an RCT because a) its a minor issue that can be dealt with easily with an outpatient or even office surgery 2) its a rare condition far more amenable to a case/control than a RCT and 3) we already know pretty much how it works, not from a RCT but from experience.

    Evidence alone is not sufficient for safe and appropriate practice. If it were, I could find you any number of hyperbrilliant fourth year medical students who has read every paper imaginable and throw him or her out to practice. Of course such a person would flounder, because evidence alone is not enough.

  12. October 14th, 2010 at 07:02 | #12

    “The reality is that the reason that this somewhat uncommon complication of a cesarean has not been heard of is not because of RCTs, its because most people are not experts in the field.”

    I wrote that several days ago, but it was deleted. As I pointed out at the time, there are literally hundreds of papers on the topic (I stopped counting when Google got to 400). The first paper I could find on Google was in 1965, and it was already well described long before then.

  13. October 14th, 2010 at 10:56 | #13

    Nicholas Fogelson, MD :

    The reality is that the reason that this somewhat uncommon complication of a cesarean has not been heard of is not because of RCTs, its because most people are not experts in the field. Any decent OB/GYN has heard of this, not because of evidence or lack thereof, but because of experience.

    The comments to Henci’s original post illustrate that doctors don’t necessarily know about this. One of the commenters wrote “When I asked my OB/GYN, she replied ‘Why would you suddenly develop endometriosis?’”. Another wrote, “it’s been 4 months of GP visits, and gyno visits, and 2 ER visits. it’s been 3 CTs, a pelvic ultrasound, and a colonoscopy. the best diagnosis anyone’s managed is ‘irritable bowel syndrome’, even though i keep insisting that my pain is not affected by food or bowel movements.”. A third commenter wrote, “I have attempted several conversations with my OB about this being a direct result of the C/s but he is not responsive.” A fourth commenter wrote, “After a couple of wrong diagnoses, a month of birth control, 5 ultrasounds, and a doctor switch (for second opinion) I finally had a lap surgery in March 2010 followed by 6 months of Lupron” Do you see a pattern? I do. Nearly everyone who weighed in on the post (which, admittedly could be a very biased group) had to be extremely proactive and put up with doctors who dismissed their symptoms and lots of unnecessary tests in order to get the proper diagnosis and treatment.

    Nicholas Fogelson, MD :
    its a minor issue that can be dealt with easily with an outpatient or even office surgery

    I dare you to write that in the comment stream of the original post. The amount of suffering detailed in those comments is immense, and typically lasted months or years. It affected women’s sex lives, their ability to care for their babies, to have more babies, and much more. Surgery to diagnose and treat endometriosis may be a technically easy procedure for you to perform, but it is not easy or minor to a woman (who, by definition in these cases has children to look after). Also, what about the many women who lose their Medicaid after they’ve reached an arbitrary number of weeks postpartum?

    Another common theme in the responses to Henci’s post is women second-guessing their choice to agree to a cesarean, or saying that they had no clue that this was a potential complication. Informed consent processes, even when they are robust (which they are often not), emphasize mortality and short term morbidity because these are the things we have the best evidence for, and they are also the things doctors see. Clinicians don’t see how choices impact women in a more global sense – their long-term wellbeing, their ability to make a smooth transition to motherhood, their future fertility, and so on. It’s hard to measure these things, but that doesn’t mean they don’t matter.

  14. October 14th, 2010 at 16:47 | #14

    Amy Romano :Surgery to diagnose and treat endometriosis may be a technically easy procedure for you to perform, but it is not easy or minor to a woman (who, by definition in these cases has children to look after).

    That’s the exact thought I had. Just because a problem is alleviated, relatively simply, from a surgical standpoint, doesn’t mean that it is simple for a woman. And, even “simple” surgery often has unintended consequences. Also, recovery is painful, hysterectomies leave a woman with an incomplete endocrine system, and usually HRT is needed.

  15. avatar
    Maureen Brook
    October 15th, 2010 at 02:46 | #15

    Hello Amy,

    I have by chance, come accross your site discussing the develoment of endometrios post C/S.I have my own case history on developing it .

    Regards ,
    Maureen

  16. October 15th, 2010 at 16:58 | #16

    Amy, this is a very insightful, and even brave, take on the evidence-based-medicine-run-amok care and treatment of pregnant women. It seems outdated and increasingly dangerous to give so much priority to evidence generated from institutions and more and more, industry. Clinical trials are expensive to run, they’re funded in dubious ways, and the results are usually debated so acrimoniously among researchers that the most novel results tend not to make it into practice guidelines for years, if ever. Add to that the fact that no one can get funded to run clinical trials on pregnant women, and one finds a true lack of good evidence for this important population.

    It’s almost cliche to say, ‘be your own healthcare advocate.’ What does that mean? I think it means exactly what you’ve described here as participatory medicine. It’s about time that actual womens’ experiences gain the credibility and the role that they deserve in womens’ care. What we can only hope for our site is that more and more women choose to share their own experiences, thereby building the stores of available evidence and common experience. For that to happen, women have to believe that their unique experiences and choices are legitimate and worthy of sharing. They are! Your piece is one more step along the way! Thanks.

  17. October 17th, 2010 at 18:33 | #17

    It is truly sad that so many women have had long term problems with cesarean scar endometriosis, and that some doctors aren’t familiar enough with it to make the diagnosis. As long as somebody is able to realize what it is, it not very hard to fix. You just open up the old incision an cut out the hard knot of endometriosis in the abdominal wall. It best done premenstrually, when the lesion is the largest and most identifiable separate from the surrounding tissue.

  18. October 17th, 2010 at 18:37 | #18

    @Amy Romano
    You make a lot of good points Amy, but Henci’s argument was not those points. It was that somehow this complication has gone unnoticed because it doesn’t show up in RCTs, which was completely wrong. It is noticed by the patients who have the problems and the OBs that do cesareans. If there are OBs out there that aren’t familiar with this disease entity and aren’t making the diagnosis, that’s a shame, because it just isn’t that hard to fix once you know what you are looking for.

  19. October 25th, 2010 at 21:11 | #19

    @ Amy:
    I can not applaud you enough for bringing to light this issue of evidence based data vs. anecdotal (qualitative)data, and the legitimacy discrepancy between these two, within our medical arenas. While in PA school, one of my favorite instructors was a family practice doc (I believe he was well into his 80s at the time) who spoke volumes about the age-old advice, “treat the patient, not the data.” Evidence, research, data…whatever you want to call it…is extremely important, but only when sufficiently verified, and then applied with a humanistic perspective that includes plentiful doses of intuition, empathy, creativity, flexibility, and an artistic approach to the otherwise scientific practice of health care.

    @ Dr. Fogelson:
    I am curious to know what, if any, research you are familiar with regarding the recurrence of endometriosis following endometriectomy? In my estimation, the complicating factor here (aside from what sounds to be a less-than-pervasive familiarity among all OBGYNs with occurrence/diagnosis/treatment of this post C/S complication) is the potential and often likely longevity of this issue. For women who are not bold enough/knowledgeable enough/ or financially capable enough to press the issue until achieving resolution: extreme cyclical pain, sexual pain, ADL (activities of daily living) dysfunction, etc. may be something they become permanently resigned to. For women who ARE appropriately diagnosed and treated…what is the likelihood that they will experience a recurrence of their C/S scar-related endometriosis months or years later?

  20. October 27th, 2010 at 21:53 | #20

    @Kimmelin Hull
    I think this discussion got a little confused with endometriosis as a whole and the specific issue of cesarean scar endometriosis.

    The former is difficult to treat, somewhat difficult to diagnose, and causes all manner of problems such as pelvic pain, painful bleeding, and infertility. If there is a strong connection between this condition and cesarean, I an unaware of that data. All women menstruate endometrial tissue into their abdominal cavities and only a minority get endometriosis, so putting endometrial tissue out there is not sufficient to cause the condition. Current theories lead one to believe that there is some sort of immune defect that interferes with the body’s natural ability to clean up those cells from the peritoneal cavity before they can implant. None of my comments were meant to apply to generalized endometriosis.

    Cesarean scar endometriosis, on the other hand, is easy to diagnose and easy to treat. I have never seen a case of recurrence after treatment. Treatment involves an incision and excision of hard ball of painful tissue in the abdominal wall. Its quite easy to see it if you wait until the patient is premenstrual, which is not a problem because that’s when the patient is going to present with pain.

    I once met a patient show up to my office with terrible pain in her old cesarean scar that had brought her to the ED on many occasions in the past without a diagnosis. She was so painful she was crying and could barely stand to be touched on her abdomen. I posted her in the OR that day and excised the area, and she was a happy woman in the PACU. Other than the pain from the re-incision, the pain she was feeling was completely gone, after years of misery.

  1. October 12th, 2010 at 08:42 | #1
  2. October 15th, 2010 at 16:44 | #2
  3. October 27th, 2010 at 21:42 | #3