• A diagnosis is a diagnosis — except when it’s not?

    cryinginfant2There is a lot of over-treatment in US medicine: the use of medications and procedures that deliver little or no benefit, increase the cost of care, and expose patients to unnecessary harm from side effects. How can we change this? It’s a deeper and harder problem than it looks.

    A case in point is the use of proton pump inhibitor medications (PPIs, familiar brand names include Prilosec and Prevacid) for the treatment of supposed gastroesophageal reflux disease (GERD) in infants. GERD is a severe problem in which the esophagus is eroded by regurgitated stomach acid. PPIs have been shown to be an effective treatment for this condition.

    However, the GERD diagnosis has increasingly been applied to infants who do not have the specific physiological symptoms of GERD, but who spit up and cry frequently and are hard to soothe. These latter infants are now frequently treated with PPIs. As Eric Hassall explains in the Journal of Pediatrics,

    in the 6 years from 1999 to 2004, there was a >7-fold increase in PPI prescription. One of the PPIs… saw a 16-fold increase in use during that 6-year period…

    Writing with a sarcasm unusual in a scientific journal, Hassall notes that

    These data would imply that somehow the diagnosis of GERD has been missed over the past several decades or has recently become a major scourge of infants in the developed world, with acid suppressing drugs becoming a new essential food group in their own right. This change in practice has come about for several reasons, none based in medical science.

    It has been true forever that lots of babies spit up a lot, cry a lot, and are difficult to soothe. And the great majority of these babies have been successfully ‘treated’ with long walks, car rides, rocking chairs, but mostly just waiting while the babies grow out of it. This is exhausting and stressful for parents. Hassall believes that the growth in the use of PPIs occurred because extensive direct-to-consumer advertising for PPIs and similar medications for adults popularized the term “acid reflux.” So it made sense to parents that these drugs would provide a solution for a seemingly intractable problem. And for doctors, calling the problem GERD and prescribing a PPI to the infant was a way to at least soothe the parents.

    The problem with that is that randomized controlled trials provide no evidence that PPIs are better than placebos for difficult infants without objective evidence of GERD. So we have a classic quality problem. PPIs are relatively but not completely safe, they cost money, and they provide no benefit when prescribed beyond a severely ill population.

    How do we fix this? One straightforward idea is that we should inform parents about the lack of efficacy of these drugs. If only it were that simple. Laura Scherer and her colleagues ran an experiment to understand how getting a diagnosis for your child affects how parents understand what doctors tell them about the benefits of PPIs.

    Parents read vignettes in which doctors talked about PPI treatment for a baby with non-specific GERD-like symptoms. There were four kinds of vignettes. Half the parents were told that the baby had GERD and half were not given a diagnosis. And half the parents were told that PPIs were ineffective, while half were told nothing about PPI effectiveness. All other information about the baby’s symptoms and the safety of the medication was the same.
    SchererFigure2
    The Figure shows that when the doctor did not tell the parents that the baby has GERD (the two right hand bars), telling the parents that PPIs were ineffective reduced the parents’ interest in the medication, just as one would expect. But when the doctor told the parents that the baby had GERD, being told that PPIs were ineffective had no effect on their interest in medicating their children.

    Why did this happen? Interestingly, it’s not the case that the diagnosis made parents believe that the babies were more ill.

    The GERD label had no impact on parents’ perceptions of illness severity, both in terms of reported amount of worry, and perceived seriousness.

    Getting a diagnosis, I speculate, activated a mental schema that “my baby has reflux disease, therefore she needs an acid-reducing medicine”, and this neutralized the information that “PPIs don’t work.”

    So simply getting a diagnosis can have a harmful side effect on parents’ understanding of physician communication. This is a quality problem in doctor-patient communication:  we need to find more effective ways to explain drug efficacy to patients.

    But the quality problem is even deeper than that. Here are some data that I have gathered about the rates of GERD diagnosis in neonatal intensive care units across US pediatric hospitals.

    GERD_Rates

    The hospital on the far right diagnosed GERD almost 13 times more often than the hospital on the far left. It is very difficult to believe that this is just a matter of varying rates of GERD across hospitals. It is likely that there is substantial lack of standardization in how the diagnosis is given. So there is another quality problem: many babies are getting diagnosed with GERD when they do not really have it, which helps generate unnecessary PPI prescriptions.

    The bottom line is that the US healthcare cost problem is in part a quality problem. Quality of healthcare is like an iceberg. On the surface, there are frightening stories about amputations of the wrong limbs and fatal medication errors. But 90% of the problem is below the surface, in routine but surprisingly difficult tasks like diagnosis and doctor-patient communication.

    @Bill_Gardner

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    • Very true and a major problem for pediatricians and family docs. There is now some evidence that PPIs increase the risk of respiratory infections so now at least one can talk about potential harms for PPIs. This might be more persuasive than ‘ineffective’. Even more important is using the term ‘spitting up’ or ‘reflux’ unless there are symptoms of pain and/or failure to thrive that would suggest esophagitis.

      • Thanks, John. My intuition would be that the term “spitting up” would be better than “reflux”, because it is more of an everyday term.

      • At least one patient per clinic day is a referral for reflux in a child under 6 months of age, all of whom have been put on a PPI or H2RA by their pediatrician for “acid reflux.” In every case I inform the family of the following:

        1. It’s ineffective at decreasing episodes of crying or frequency of regurgitation.

        2. It has the following side effects: increased risk of pneumonia, increased risk of viral gastroenteritis (http://www.ncbi.nlm.nih.gov/pubmed/16651285), and increased risk of C. diff infection (for older children).

        In nearly 100% of cases, the family wishes to discontinue the medicine.

        I think the problem is even simpler than you suggest. If families were simply adequately informed of the risks of medication, they would frequently opt to observe rather than treat. However, having spoken about this topic to general pediatricians frequently, I find that few are aware of potential side effects in infants.

    • Bill
      You are paying short shrift to the problem.

      The communication goes beyond explanation. You need to debias the parents.

      Explaining why the rx wont work conveys just as an ineffective message as why vaccines dont cause autism.

      Why do you think these parents resisted the call and wished to accept the PPI?

      –Not my child, mine is different
      –They were wrong about silicone implants, why not PPIs
      –Tylenol works for me and my kid, just at a lower dose. I dont believe.
      –The doctor just wants an extra follow up visit.

      We never bring these points out: time sinks and more to the point, training.

      Brad

      • Brad, I wouldn’t begin to pretend that I know anything useful about how to do communication.

      • Having been through this myself and having friends who made similar choices in the vaccine controversy, you have to address the issue of why the kid in question might be different.

        At the height of the MMR-Autism scare, I didn’t hear from any doctor, public health official, research any discussion of how risk might change for a child with a possible genetic tendency towards autism. I remember hearing from a friend whose doctor couldn’t discuss her child’s risk of an adverse reaction to DPT, if several relatives had had febrile convulsions from DPT.

        And it’s worth remembering that if you’ve lived with a relative with autism or watched a tot have febrile convulsions, that’s a very real threat to the parent.

    • I’m a parent of two kids who were on PPIs for GERD, but were never formally diagnosed, they just had symptoms of unconsolable crying, classic colicky babies. I think that I would have tried anything, I looked at every resource available, even had someone recommend that I take them to a chiropractor (but I didn’t do that). The psychological stress of living with an infant who cries constantly is widely underestimated until you have been through it. If not PPIs, then something else has to be offered to parents in the doctor’s office. An explanation that PPIs are not effective, without any alternative, without being able to take any other action, would have made me just crazier and more desperate.

      • You have my sympathy — my two biological kids had very easy dispositions. But my wife tells me that she went through something similar with my oldest stepson; it sounds terrible.

        Having said that, are you saying that you think that pediatricians should prescribe PPIs in this situation?

    • Amy, I’m also a parent of reflux babies and a doctor. I agree, I think until you have been stuck in a house with a baby that cannot settle, for months, you cannot really know how hard it is. I would like to see some studies looking at whether there is correlation btw reflux and shaken babies. Also with PND, and car accidents. It was only when I nearly killed the 3 of us by nodding off at the wheel that I took our sleep issues seriously. I might add that advice to reduce SIDS risk results in some babies that cannot sleep (hence they don’t die). OK I’m joking but you get the point. I think our relative social isolation is part of the problem- there is no extended family to pass the baby to. To those who think reflux is all in the mother’s head, or that she just lacks stamina, I invite you to swap. What is needed is an informed balanced dicussion. Some babies will need PPIs, and a drug trial seems less risky to me than a scope.

      • I’ll disagree on two points:

        1. All babies are “reflux babies.” GE reflux is a physiologic condition in all humans, but especially infants. One of the key solutions to this problem is to get away from terminology which medicalizes a normal process (and a process, it turns out, that plays an important role in innate immunity from some infections). I usually advise patients, and general pediatricians, to use the term “regurgitation” or “spit up.”

        2. It isn’t necessary for us to have a child with a specific disease (or symptom) to “get it,” or to be able to advise patients properly. I have seen so many kids with symptoms attributed to reflux, that I feel vastly more qualified than any parent to advise the next person on what to expect. In fact, it may even be advantageous to not have the subjective, somewhat emotional perspective of the parent (or worse, in our cases, the physician-parent) – I think seeking advice from someone with a purely objective perspective is essential.

        That being said, my younger son was the fussiest, refluxiest baby ever. I bring this up with nearly every patient’s family, and they take more solace from this than they do my many years of experience, training, and research. Go figure.

    • Let me rephrase and generalize Amy’s statement: Telling a patient or his guardians there is no hope can lead to desperation. The question is what should a doctor do in such circumstances. This is a situation where costs can get out of control and/or harm the patient or people around them. What does anyone suggest? Jackie presents the problem of tradeoffs. Resources used in one area takes those resources from another and can as Jackie says lead to death.