In the hierarchy of evidence-based medicine (EBM), randomized controlled trials (RCTs) are like Brahmins. But do Brahmins have flaws? I discuss these flaws with Dr. Anish Koka, a cardiologist, and essayist who has writtenextensivelyaboutRCTs in THCB.
Listen to our conversation at Radiology Firing Line Podcast.
About the author:
Saurabh Jha is a contributing editor to THCB and host of Radiology Firing Line Podcast of the Journal of American College of Radiology, sponsored by Healthcare Administrative Partners
I have a wide ranging conversation with Dr. Nicole Saphier for JACR’s Firing Line Podcast. Dr. Saphier is a radiologist specializing in women’s imaging. We discuss screening mammograms and the breast density law. Dr. Saphier, a frequent contributor to multiple major media outlets, tells us what it means for a radiologist to opine on health policy in the national media.
About the author:
Saurabh Jha is a contributing editor to THCB. He’s the host of JACR’s Firing Line Podcast. He can be reached on Twitter @RogueRad
After the Napoleonic wars, the price of corn in England became unaffordable. The landowners were blamed for the high price, which some believed was a result of the unreasonably high rents for farm land. Economist David Ricardo disagreed.
According to Ricardo, detractors had the directionality wrong. It was the scarcity of corn (the high demand relative to its supply) that induced demand for the most fertile land. That is, the rent did not increase the price of corn. The demand for corn raised the rent. Rent was a derived demand.
Directionality is important. Getting directionality wrong means crediting the rooster for sunrise and blaming umbrellas for thunderstorms. It also means that focusing on medical imaging will not touch healthcare costs if factors more upstream are at play.
Medical imaging is a derived demand. The demand for healthcare induces demand for imaging. Demand is assured by the unmoored extent to which we go for marginal increases in survival.
Archie Cochrane was born in Scotland, educated in London (King’s College, University College and London School of Hygiene and Tropical Medicine) and worked in Cardiff, Wales. His work as a doctor during the Spanish Civil War and World War II, especially in a prisoner of war camp in Salonica, is credited with his push towards generating higher quality evidence. In his description of the clinical trial he conducted, he mentions James Lind as his hero. Ironically, that clinical trial – with weak randomization, open allocation, non-blinding of investigator or participants, and use of surrogate outcomes, would rate poorly in the Cochrane risk of bias tool.
But the scientific method of measuring stuck with him, and among many other achievements, he did perform a proper randomized clinical trial (RCT) a few decades later. He continued to be a strong supporter of RCTs and pushed for the Medical Research Council (MRC) to move from purely fundamental research towards applied clinical research. As an aside, the first proper RCT in the modern era was funded by the MRC and was published in 1950 – on the use of Streptomycin vs para-aminosalicylic acid, or a combination, in tuberculosis. Far more influential was his paper (and later book) published as part of the Rock Carling Fellowship, available here freely and worth a read. It’s where he puts forward the vision for RCTs in moving towards what he termed an ‘effective, efficient health service’.
Public reporting of doctors is fiercely controversial. I’m vehemently opposed to it. So I decided to find out why its proponents favor it.
I discuss public reporting with Ben Harder, Chief of Health Analysis at U.S. News and World Report, for JACR Firing Line. We disagreed for most parts, though we agreed that there are bad ways to rate doctors, and better ways, too. Listen to our discussion here.
Key points made by Ben Harder:
a) Reporting of quality is a decision support tool for patients and their caregivers. It is NOT to penalize or shame doctors but to engage consumers in their healthcare decisions. This is an important distinction.
b) If methods to rate quality are so bad how is it that hospitals which look after the sickest patients also have the highest rating?
c) Newer methods to rate quality make a huge effort not to compare apples (hip surgeons) with oranges (knee surgeons).
d) We are still suffering the legacy of poor risk adjustment.
India and Pakistan celebrate 71 years of Independence today. The British National Health Service owes them a debt of gratitude.
Great Britain’s national dish is famously chicken curry, but South Asia’s impact on this Sceptred Isle extends far beyond food. It is a testament to how ingrained into the British psyche the stereotypical Indian doctor has become that in 2005 a poll of Brits found the doctor they’d most like to consult is a 30-something South Asian female. In 2010 the BBC even ran a popular TV series simply entitled ‘The Indian Doctor’ following a story played out across the UK in the 1960s and 1970s, that of a humble family physician from the Indian subcontinent finding his feet in a country that asked him to come over and save the still-young ‘National Health Service’.
In 1948, India and Pakistan were not yet one year old when the NHS was created. Over subsequent years, recruitment drives encouraged young doctors to make a new home in the UK. Tens of thousands answered the call and it is no exaggeration to say the NHS would not have survived without them.
Now a swollen behemoth comprising some 1.8 million staff, the NHS is the world’s fifth largest employer. It is estimated to have a bewildering shortfall of 100,000 staff. Unsurprisingly almost 40% of Tier 2 (skilled) visa applications to the UK are to take up positions in the NHS. Yet over the last 13 years, South Asian doctors have been made to feel less welcome. In the first four months of 2018 alone, 400 visa applications from Indian doctors were rejected.
This is the second part of Dr. Jha’s conversation with Dr. Jonathan Cusack, who was the former supervisor and mentor of Dr. Bawa-Garba, a pediatrician convicted of manslaughter of fetal sepsis in Jack Adcock. Read the first part of this series here.
Dr. Jonathan Cusack versus the General Medical Council
I spoke with Dr. Jonathan Cusack, consultant neonatologist at Leicester Royal Infirmary (LRI), and former supervisor and mentor of Dr. Bawa-Garba, the trainee pediatrician convicted of manslaughter for delayed diagnosis of fatal sepsis in Jack Adcock, a six-year-old boy with Down’s syndrome. We had drinks at The George, pub opposite the Royal Courts of Justice.
In the first part of the interview we discussed the events on Friday February 18th, 2011, the day of Jack presented to LRI. In the second part of the interview we talk about the events after fatal Friday – how the crown prosecution service got involved, the trial, the manslaughter charge, the tribunal and the General Medical Council.
The Role of Dr. O’Riordan
Saurabh Jha (SJ): After Jack’s death what was Dr. Bawa-Garba’s immediate reaction?
Jonathan Cusack (JC): I think it’s one of those moments one neither forgets nor recalls. I imagine the most overwhelming feeling was one of incredulity. How and why did Jack decompensate? It’d have struck her as physiologically implausible. Though she was experiencing that grief familiar to all pediatricians when a child dies, she was trying to understand why. She didn’t know that he died from Group A Streptococcal septicemia, then.
Life is busy, yet we somehow find time to stay engaged on social media, remain engrossed in the 24/7 news cycle, and continue our futile efforts to resist clickbait. While social media can allow us to mindlessly scroll through feeds, it also provides an avenue to provoke vigorous dialogue, however diverse, controversial, or even rooted in unfettered biases. These exchanges have served as the primordial soup for a virtual friend or foe-ships. Tense and argumentative Twitter exchanges are especially entertaining given the challenges in justifying a position in fewer than 280 characters. Thus, tweetorials have emerged to explain a point of view via a thread of comments since it is not always easy to do so in 1 or 2 tweets. The longer the tweetorial, the more heated the debate. What I am trying to get at here, somewhat obtusely, is the concept of surrogates.
I have already suggested a surrogate. Length of a tweetorial is a surrogate for degree of controversy of the topic. Meaning, length is a surrogate, a proxy. We are surrounded by surrogates. Longer wait lines at restaurants and bars imply a hipper joint or tastier menu. My child being extra nice to me is a surrogate for him wanting more time on electronics. Not a day goes by without folks arguing about surrogate endpoints. I wanted to dig deeper into surrogates and since I am a physician, I’m focusing on surrogates in medicine. Apologies to those who thought I would be discussing restaurants or exotic trips.
I want to make sure my definition of surrogates is accurate: Merriam-Webster dictionary for enlightenment. The first use of the word “surrogate” was in 1533, B.T. (“Before Twitter”). A surrogate is defined as “one appointed to act in place of another” or “one that serves as a substitute”. We use surrogate endpoints in clinical trials as a substitute for other end points.
After Dr. Hadiza Bawa-Garba was convicted for manslaughter for delayed diagnosis of fatal sepsis in Jack Adcock, a six-year-old boy who presented to Leicester Royal Infirmary with diarrhea and vomiting, she was referred to the Medical Practitioners Tribunal (MPT). The General Medical Council (GMC) is the professional regulatory body for physicians. But the MPT determines whether a physician is fit to practice. Though the tribunal is nested within the GMC and therefore within an earshot of its opinions, it is a decision-making body which is theoretically independent of the GMC.
The tribunal met in 2017, 6 years after Jack’s death, to decide whether Dr. Bawa-Garba, after the manslaughter conviction, should be allowed to practice medicine again, whether she should be suspended for a year, or her name be permanently erased (“struck off”) from the medical register. The GMC wanted Dr. Bawa-Garba to be struck off from the medical register because they felt that her care of Jack fell so short of the expected standard, that her return to practice would not only endanger patients but undermine public confidence in the medical profession. The GMC expected the MPT to agree with its uncompromising stance, and the MPT might well have, and probably would have, but for the efforts of Dr. Jonathan Cusack, a consultant neonatologist at Leicester Royal Infirmary (LRI), and a former supervisor and mentor of Dr. Bawa-Garba’s.
Cusack is unassuming even by British standards. You will not find him on social media or taking selfies. A soft-spoken northerner with a steely nerve and an uncompromising deference to facts, Cusack is both old-school and new-school. He has that unassailable integrity which is immeasurable but instantly recognizable. But he’s also savvy – and understands the British medical, regulatory and legal systems inside out. If Dr. Bawa-Garba’s license is reinstated, Cusack’s role would be akin to that of the code breakers in the Second World War. Dr. Bawa-Garba trusts him implicitly. Her legal team can’t function without him.
Cusack was loyally involved in both the rehabilitation of Dr. Bawa-Garba’s clinical confidence after Jack’s death, and her trial. I met him after the first day’s appeal hearing in the pub opposite the Courts of Justice. Originally hesitant to speak to me, being the ostentatious expat Brit that I am, he agreed to an interview on the condition that I not make too much of a song and dance about his contribution. I promised that I wouldn’t. I lied.
There is a rage against expertise these days. Data is all rage. What is the value of experience and judgment when we have abundant information, guidelines, and protocols? Can’t we just have a protocol for every situation? Are doctors overly concerned about making errors? I discuss these issues with Gary Klein, a renowned cognitive scientist and author of Streetlights and Shadows.