(Reuters Health) – Thousands of studies have examined the value of tonsillectomies, but whether the benefits of the procedure outweigh the risks for a given patient still isn’t always clear, according to a commentary July 6 in JAMA Otolaryngology.
“Despite over 10 years of tonsillectomy research, 9,000 publications in the field and millions spent on research, the research we have still is not sufficiently strong to draw firm recommendations on our practice,” said Dr. Rishi Mandavia, an ear, nose and throat specialist at University College London in England.
He spoke in a Skype interview about tonsillectomies, a procedure he performs. But the inability of research to answer pressing public health questions extends well beyond whether sore-throat sufferers should have their tonsils removed, he argues as the lead author of the commentary.
The review builds a case for research that’s more responsive to patients and policymakers.
“This is not just a problem for tonsillectomy,” Mandavia said. “This is a problem for many surgical procedures. Tonsillectomy is such a great, prime example.”
In the U.S., where more than 750,000 tonsillectomies are performed annually, and the UK, where another 60,000 a year are done, guidelines to determine suitability for the surgery are based on recurrence of throat infections.
But, Mandavia said, “I’m sure patients would be surprised to know that the criteria we use to select patients have been arrived at arbitrarily. They’re not evidence-based, which is a bit crazy, isn’t it?”
Dr. Jay Piccirillo, a professor at Washington University School of Medicine in St. Louis, Missouri, sees the current research model as seriously flawed.
“All of these millions of dollars don’t provide the answers,” he said in a phone interview.
“As a physician, why can’t I pull up National Institutes of Health research on whether or not my patient should have a tonsillectomy?” asked Piccirillo, an otolaryngologist who wrote an accompanying editorial. “The NIH doesn’t fund that research.”
“The scope of research funded by NIH is predominately basic science molecular research. It cannot answer the questions that physicians ask every day,” he said.
Researchers view patients’ questions as too “subjective” to be included in clinical trials, Piccirillo and his co-authors write.
Moreover, industry sponsors 70% of clinical trials, and industry-sponsored research can distort scientific literature when, for example, pharmaceutical companies choose not to publish negative findings, the editorial says.
Piccirillo makes his point with research into the effectiveness of antidepressants. Although 94% of 47 studies showed that pharmaceutical drugs lifted depression, he writes, a fuller examination found that only 53% of 70 studies showed antidepressants to be effective.
Mandavia would like to establish a registry for patients who undergo tonsillectomies so that researchers can follow them and see how they fare after surgery.
“Research needs to serve patients. I think we should ask patients, ‘What’s important for you?’ he said.
“We’re answering questions that clinicians and academics want answered, but we need to really focus on the questions that patients and policymakers want answered,” he said. “I truly believe that we need to bridge this gap.”
The disconnect between research and practice is a great source of frustration for Piccirillo and Mandavia, and the approach to tonsillectomies epitomizes the problem, they said.
Current tonsillectomy guidelines are based on 1984 criteria, which included clinical trials of children, not adults, and failed to include some of today’s surgical techniques, Mandavia and his co-authors write.
A 2014 Cochrane review found no good evidence to recommend adult tonsillectomy and raised a host of questions about whether the benefits outweighed the risks for children.
People are having tonsillectomies who shouldn’t be, according to Mandavia. “There are risks,” he said. “Around one patient in the UK dies every year after tonsillectomy.”
A recent Pediatrics study found that children who underwent tonsillectomies had roughly the same number of throat infections as those who kept their tonsils three years after surgery.
The senior author of the Pediatrics study, Dr. Sivakumar Chinnadurai of Vanderbilty University in Nashville, Tennessee, said in an email that a push for more evidence-based healthcare might help close the gap between the questions raised by researchers and those footing the medical bills.
“Currently, there is a strong move in healthcare to demonstrate value – maximizing quality and minimizing cost,” said Chinnadurai, who was not involved with the current study.
While data on the cost-effectiveness of tonsillectomies “hasn’t existed in the past,” he said, “it is increasingly being demanded by insurers, including the government.”
SOURCE: http://bit.ly/2veUYV0 and http://bit.ly/2uwnvbc
JAMA Otolaryngol Head Neck Surg 2017.
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