In the last few weeks it was announced that the inquiry report on convicted surgeon, Ian Paterson, is being pushed into next year. He tried out unorthodox operations, resulting in harm to many patients. There were systemic failures that allowed this.
Trying different surgeries can put patients at risk so it needs to be done with proper oversight, informed consent and full disclosure of data and conflicts. Doctors know this, but only last week BBC’s Newsnight reported on a major study where it’s said that serious harm to patients was downplayed. The European Association for Cardio-Thoracic Surgery (EACTS) has released a statement supporting the BBC’s investigation. Others have made the issue crystal clear too:
Data transparency is a critical patient safety issue
– Rita Redberg, Cardiologist, UCSF; Editor, JAMA Internal Medicine; December 2019
Stent vs surgery
In a nutshell, the BBC reported that (a) researchers with declared conflicts, such as financial interests in stent technology, published only part of the outcome data of their EXCEL trial; (b) this incomplete data undermines the study’s claim that stents are as good as surgical bypass for coronary artery disease of the left main stem, in those low and medium risk cases studied; (c) longer term follow up reveals that stents were associated with 135 deaths for every 100 surgical deaths.
As a result of the Newsnight investigation, EACTS has withdrawn guidance suggesting that stents and surgery are equivalent choices for this type of disease.
The Newsnight report shows the vital importance of data transparency, not least to allow people to give informed consent to their choice of potentially life-changing care. The BBC investigation also highlights how even leading journals can publish major studies with important data missing.
Anti-reflux surgery in children
Similar issues arise over a different operation. In neurodisabled children, stomach content can tend to reflux back up the into the gullet, causing a range of problems. When medications and other measures fail to control this, surgery may be offered. The National Institute of Clinical Excellence (NICE) lists the standard surgery which is a procedure called fundoplication. Part of the stomach is wrapped around the gullet, in a manner said to create a valve of sorts.
An Alder Hey surgeon has been adding two more procedures (vagotomy and pyloroplasty), trying to test if that improves on standard fundoplication. The same surgeon has admitted on oath to serially altering documentary evidence; evidence he’d submitted to the General Medical Council (GMC) with a statement of truth. He and Alder Hey colleagues also discussed using referral to the GMC as a weapon against those reporting concerns about his surgery. If that weren’t enough to ring alarm bells, two fundamental questions remain unanswered.
(1) Is consent informed?
At even a basic level of care, parents ought to have been told that (a) fundoplication is the current standard surgery, as per NICE; (b) addition of vagotomy and pyloroplasty necessarily adds risk (this includes leak – which is graded a 3 to 5 complication, where grade 5 includes death); (c) we don’t know if these additional procedures help or harm overall. Knowing this, it’s hard to see how any parent would submit their child to the additional vagotomy and pyloroplasty, especially given the lack of research ethics (REC) approval.
Informed consent is a legal requirement, so it’s troubling that investigations by the Royal College of Surgeons (RCS) in 2011 and then the GMC in 2015 have both been unable to prove that Alder Hey is obtaining informed consent for the added procedures.
The GMC accepted that Alder Hey’s reported data lacked information on complications, including cause and time of death. The GMC recognised this would undermine parents’ ability to give informed consent. But it then excused this gap – on the assumption that the practice of consent for these added procedures probably fitted with that of other surgeons.
That’s an error in both fact and law.
In fact, the overwhelming majority of U.K. paediatric surgeons who do fundoplications do so without adding vagotomy and pyloroplasty.
In law, the test for informed consent is, anyway, based on what prudent parents would want to know, rather than what other doctors would routinely share. Any parent would want to know if adding vagotomy and pyloroplasty shortened survival after fundoplication surgery. Yet the full Alder Hey data remain stubbornly undisclosed.
Informed consent is an important safety issue. Sir Ian Kennedy QC, veteran investigator of the surgical scandals at Bristol and Solihull, has recognised that surgeons may have lengthy disputes over techniques. So for safety and speed, he’s said it’s vital first to determine whether informed consent is being given.
Remarkably, in Alder Hey’s case, despite two investigations, we still can’t tell. This is surprising given that Alder Hey ran into major problems with informed consent over the organ scandal. It’s concerning given that Sir Ian’s Solihull report (quoted below) highlighted how repeated failures to analyse consent can leave so many people in harm’s way.
Seen in this light, action would have been of a different order. It could have been prompt and put an immediate end to Mr Paterson’s deviation from accepted practice. But, it was a matter calling for proper analysis. Instead, it was under-analysed, or mis-analysed by those responsible for taking action. This is not a judgement of hindsight. The centrality of proper consent to the care of patients is, and was then, a given.
– Solihull Report, Sir Ian Kennedy QC
(2) Why withhold the full data?
Since 2009, Alder Hey has been chased for the complete data on children who have undergone vagotomy and pyloroplasty on top of standard fundoplication. The surgeon responsible still hasn’t disclosed his full outcome data, even after the quality of his published findings was criticised by the GMC, and described as “tenuous” by one of the world’s leading experts on medical statistics. Alder Hey has resisted data transparency – even after the (limited) published data indicate that children having these additional surgeries may, in fact, die sooner.
Alder Hey’s refusal to disclose data in full is a serious breach of fundamental principles set out by Sir Ian Kennedy QC almost twenty years ago in the Public Inquiry Report into Bristol (below). Put simply, informed consent requires data transparency:
Consent by a parent is quintessentially a process. It has little to do with putting a signature on a form, and everything to do with being taken along a journey of information, advice and support which equips the parent as much as possible to make the necessary decision. Nor can there be any justification for holding information back, however well intentioned the motive. This is because it is the parent’s responsibility to make a decision which is in the child’s best interests. That responsibility falls (and weighs heavily) on the parent, not the doctor, the nurse, or anyone else. To carry out this responsibility the parent therefore needs the fullest possible account of what is proposed, the alternatives, the risks and the possible outcomes. [underlining added]
– Report into Bristol Heart Surgery, Sir Ian Kennedy QC
Acting as a profession
Unlike the stand taken by EACTS on behalf of patients, the British Association of Paediatric Surgeons (BAPS) has weighed in on behalf of the Alder Hey surgeon. Rather than seeking Alder Hey’s full data, BAPS has appeared to quell inquiries over the additional vagotomy and pyloroplasty. BAPS also claimed it planned to audit such procedures nationally. Years on, we still await open publication of that data too. Conflicts of interest may be an issue because Alder Hey surgeons have repeatedly held senior roles within BAPS.
Beyond BAPS, the first report to cite and copy Alder Hey’s approach, ended in failure. Vagotomy and pyloroplasty were added to standard surgery, but the child lost so much weight that their pyloroplasty had to be reversed at a redo-operation. This complication could have been avoided had they stuck to the normal surgery.
None of this is that surprising. Eminent surgical authorities have long described the added procedures as “meddlesome”.
…adding a pyloroplasty is meddlesome and may result in early dumping or other symptoms. Thus, Prof. Watson’s statement that vagotomy should not be part of any fundoplication is quite reasonable.
– J.E. Fischer, Harvard Professor of Surgery
When will the RCS and BAPS have the courage to follow EACTS’ lead and dissociate themselves from Alder Hey’s published paper until full data disclosure has been achieved – and that data verified and independently analysed?
What if, as appears, the added surgeries have been reducing survival? That’s something any parent would want to know before deciding on consent. It’s something any profession worthy of the name would also want to determine without further delay or doubt.