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This week's title applies to both the hot weather spike in many parts of the country and the many political and other hot spots at home and abroad. I'm anxiously looking forward to the upcoming ACIP meeting this week, now shortened and with alterations to the discussion topics. I hope to be able to view all of the proceedings and will report back on that next week.

Compared to global news in general, this past week in pediatric infectious diseases was relatively quiet.

Journal Transparency

Here's an idea I hope catches on. The journal Science announced that their suite of publications will increase the transparency of their peer review process. For several years this journal has offered authors the option to have the peer review reports published alongside their papers, though the authors could opt out of this. Now, these peer reviews will be published routinely with new published studies. Peer reviewers will have the option to have the reviews to appear anonymously or with their names attached.

Every journal for which I've reviewed allowed me to see the other reviewers' opinions, after everything was submitted and a publication decision was finalized. It's been interesting to compare my reviews to others' and seeing those comments helped improve the quality of my subsequent reviews. Allowing journal subscribers to see all the reviews certainly will offer more transparency and nuance to the articles. If all journals adopted this approach, predatory journals and paper mills will have a lot more trouble fooling the public.

Hats off to the Science editorial board!

New Recommendations for Perinatal Urinary Tract Dilation

I've frequently encountered the clinical situation of a newborn infant with dilation of the urinary tract in either prenatal or postnatal imaging studies, often in connection with a possible urinary tract infection. Most of my cases didn't arise at the "mother ship" (Children's National Hospital) with its impressive array of pediatric pre- and post-natal imaging experts and pediatric urologists, but rather at regional hospitals in the DC area where pediatric imaging and urology expertise wasn't readily available. Still, those hospitals could always "curbside" experts at Children's National for more help. But what about hospitals and clinicians without ready access to subspecialty expertise?

These new recommendations from 4 different AAP subspecialty sections, available without subscription or AAP membership, are a great resource. I learned a lot from them even though I've been dealing with these clinical scenarios for decades.

I didn't know that perinatal UTD occurs in 1% of all pregnancies, second only to congenital heart defects in prenatal detection. The recommendations are very detailed, covering a number of clinical situations, but note that it does not cover boys with more severe bilateral UTD who likely have a posterior urethral valve or other severe obstruction and should have subspecialty consultation. I'll mention just a few features of the article.

Be aware that there is a generally accepted scoring system for UTD; this is nothing new.

The scoring system and specific abnormalities can lead to a plan for further postnatal evaluation which of course has risks and benefits (apologies for the colors, not my choice!)

As I said, the article is very detailed, ending with 18 separate recommendations. I think it will be of greatest use for neonatologists and pediatric hospitalists, but I believe even frontline primary care pediatric providers need to be aware of them to ensure that infants are being managed appropriately and not falling through the cracks among various other providers. Don't memorize this article (that would be nearly impossible), but keep it at ready access for that subset of your patients.

Hope for the Best, Plan for the Worst

Good advice for most circumstances, but now it could be crucial for what's happening with CDC's Advisory Committee on Immunization Practices as we plan for preschool and other late summer/early fall vaccinations. I've mentioned in earlier posts that CIDRAP's Vaccine Integrity Project kicked off a couple months ago, and now they already have news of their preliminary diagnostic phase where their steering group discussed how best to maintain reliable scientific data on vaccine safety, efficacy, epidemiology, and feasibility even if ACIP ceased to be a reliable recommendation group. They listed results from those 6 high-level recommendations emerging from this process. Areas covered include

  • Increasing Communication and Improving Information Dissemination
  • Developing and Disseminating Clinical Tools and Guidelines
  • Maintaining the Nation’s Vaccination Infrastructure 
  • Stabilizing the Vaccine Safety System 
  • Supporting State and Local Health Departments 
  • Safeguarding Insurance Coverage 

They also mention a number of next steps, and I'm somewhat optimistic that some of this will be operational later this summer. Of course, this group can't do much for vaccine approvals, that's under the auspices of FDA, but we may see a new, parallel structure to ACIP's usual role as providing recommendations for how vaccines are used. This week's ACIP meeting should be very telling about whether we'll need a parallel structure.

What's a Good Beach Read?

Really that's a personal decision, although I think the generic answer to that question is similar to the Merriam-Webster dictionary definition: "a usually light work of escapist fiction (such as a thriller or romance)." I'm partial to a recent definition in the Seattle Times with the subheading, "Your Brain Knows the Answer": "A beach read is a book that is simple in tone and subject yet entertaining. A reader can often finish it quickly, ideally in a day or two, while poolside, and can set the book aside for a time without losing the thread of a complicated plot."

With that in mind, here's one of my beach read recommendations, a book I read this past week. Last Night at the Lobster by Stewart O'Nan is a 146-page novella published in 2007. It's about the employees' last day at a Red Lobster restaurant in the midst of a northeast snowstorm, not exactly the most exciting topic on its surface. I loved it. After I finished reading it I read a lot of the reviews, but none of them really could explain to me why I was so enthralled with this book. Try it out, at worst it will only cost you a few hours.

Sad to say, I read this before my beach vacation will commence. Two tomes I'm considering taking along are Hernan Diaz's Trust and Seishi Yokomizo's The Village of Eight Graves. I suspect neither of them quite align with the Seattle Times definition above. I'm also hoping my granddaughter with put up with an out-loud reading of The Robber Hotzenplotz by Otfried Preussler.

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It's always been hard to keep up with the medical literature, especially to figure out what original articles are of high enough quality to warrant a change in your clinical practice. It's not enough to just read the abstract, or to be reassured because the authors are from a reputable institution or the article is published in a reputable journal. I've been teaching Evidence Based Medicine (EBM) in various formats for over 20 years, including a full graduate school course for a while. I've learned a lot, both from reading but also from my students and colleagues, about how to sort through the jungle of words and diagrams in medical articles to pick up those rare pearls of good information.

EBM officially came into being in the early 1990s and, like most things, it has evolved. What hasn't changed much, however, are the forces that result in low quality evidence being published and advertised:

  • Pressure on researchers to "publish or perish." This not only involves job security and academic promotion but also a natural desire to make a name for oneself.
  • Pressure from academic institutions to ask their researchers to "hype" their studies in the hopes of increasing organizational rankings in national publications and also increase charitable donations.
  • Complicity from the lay press, anxious to describe in breathtaking fashion a new study, even if it has no direct relevance to clinical practice or improving lives of their viewers/readers.
  • Efforts from commercial organizations, such as pharmaceutical companies, test developers, and device manufacturers, to sell their products.
  • Predatory journals who will publish anything for a price. (One "gotcha" study showed how one of these journals published a report taken straight from the pages of a "Seinfeld" script - clearly totally bogus and obviously published in such a journal without any editorial review.)
  • Failure of the medical community as a whole to convey the inherent uncertainty in medical science - very few things are absolute "facts."

All of this just got worse in the pandemic era. Individual clinicians, researchers, and organizations seem bent on being the first to report the newest covid finding, and publishers and the lay press are anxious to help them. Unfortunately, things have moved too fast. Just recently, 3 major journals (New England Journal of Medicine, Lancet, and Annals of Internal Medicine) retracted publications due to, in my opinion, sloppy editing - plain rookie mistakes likely due to being in too much of a rush. (Actually as I'm writing this I heard about a potential new retraction with Proceedings of the National Academy of Sciences regarding mode of transmission of SARS-CoV-2). It is even harder now for those of us at the point of care to digest the onslaught of poor science looking for the truly helpful articles. However, there is still hope, and here are some quick guides to survival in the Pandemic Era of Medical Practice (PEMP, I just made up that acronym).

The image above is one I've used many times, most recently at a talk I gave at the AAP NCE meeting last fall. It is my version of the "evidence pyramid," a hierarchy of studies much misunderstood by the general medical public. Simply explained, results utilizing the study design types at the lower end of the pyramid are more likely to be shown to be wrong when subsequent studies, usually from a higher design type in the pyramid, are performed. Also, note that pure bench studies and animal studies aren't even part of the pyramid; those studies would not immediately impact clinical (human) medical practice. Also be aware that a poorly-designed randomized controlled trial (RCT) wouldn't be near the top of the pyramid; bad science can occur at all levels and trumps the pyramid ranking.

The vast majority of design types we are seeing related to COVID-19 are case series, i.e. just a report of what was tried and what happened, usually of a retrospective nature. It's not that these studies are bad, but compared to a randomized, placebo-controlled double blind trial of a new therapy, it just doesn't stand up. The gap between the lower and upper ends of the pyramid are magnified when we are dealing with a completely new disease like COVID-19.

(BTW, if you are wondering about GOBSAT, I wish I had invented the acronym but I didn't. It stands for Good Ol' Boys Sittin' Around a Table, another word for expert opinion. Again, if that is all we have to go on, I'm certainly interested in what experts think, but it's astonishing over the years how often GOBSAT opinions are reversed when better studies are performed.)

So, here's a quick and dirty approach of how I keep up with the flood of medical studies. First, I look at the abstract. If it sounds like something worth reading more, I then go immediately to the Methods section of the article. Yes, I know that section is the most painful of all, but that's where I figure out study design and whether the study may have critical flaws that would affect study results. Also, in spite of modern-day editing, even the best journals still allow conclusions to appear in the abstract that aren't supported by the study itself; usually they just represent the authors' conjectures but aren't labelled as such. If the Methods section doesn't pass muster, I don't read the rest of the article. If, however, the Methods look reasonably sound (remember, this is biology, we can't expect perfection in any study) I look through the results and discussion to see if this is something that would apply to my patients.

One more point that has just surfaced during PEMP. I'm starting to see increased alerts about manuscripts submitted to pre-publication web sites. Prior to the pandemic, these were sites where authors submitted data to be looked at by other scientists. They were not necessarily even submitted to a journal, just a way to increase transparency and actually a good thing. One key important fact is that the documents have not undergone any peer review at all. Unfortunately, now many authors are submitting results of case series and the like to these sites, and the lay press and even otherwise sound academicians are referring to these as "publications" when in fact they are nothing of the sort. As a reviewer for many medical journals and author of a few scientific articles, I can tell you that most articles submitted for publication undergo many, many significant changes before publication. I wouldn't advise clinicians to even look at these postings, they are useful only if someone is trying to design a research study on a similar topic. Some of the web sites include medrxiv.org and biorxiv.org. Again, nothing wrong with these sites other than how they are currently being misused by a few individuals.

So, I would advise you all not to be too discouraged by the confusion and flood of information. Listen to the lay press so you know what your patients and families are hearing, read the key articles, and be prepared to answer questions in your practice.