'This is a nightmare': patient on differing accounts of surgical study's purpose

News Apr 01, 2016 by Joanna Frketich The Hamilton Spectator

Patients give vastly different accounts than the researchers of what is being studied in a Hamilton trial that has raised serious questions about informed consent.

Three patients give identical descriptions of what they say Dr. Olufemi Ayeni told them he was researching in the Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST), which to date has involved 54 people put under general anesthetic at McMaster University Medical Centre.

Their understanding of the study's aim bears zero resemblance to the contradictory explanations provided by principal investigators Ayeni and Dr. Mohit Bhandari.

"I'm curious," said patient Steve McBride, who had the surgery 18 months ago. "Was it really done, what was said was done?"

McMaster, HHS and the researchers did not respond Friday to questions about what patients are told, what the study is testing and why the descriptions are so different.

Instead they released a statement saying, "McMaster University and Hamilton Health Sciences recommend that any patient who has questions about their care, including medical procedures or surgery, should contact their physician."

It is not clear if any of the three patients who contacted The Spectator ended up in the pilot or ongoing surgical study at McMaster University and Hamilton Health Sciences.

But they say Ayeni attempted to recruit them during appointments about surgery for a painful condition where there is a mismatch of the ball and socket in the hip joint.

All three describe the study as testing the North American versus the European way of doing femoracetabular impingement (FAI) surgery.

"One (group) was going to be doing it the North American way and one was the European way and he's done both," said McBride. "He said, 'They're equally as good.'"

There is no reference to a North American versus a European way of performing the surgery in the patient consent form.

It is not mentioned in a number of published accounts of the study, including an article in the journal BMC Musculoskeletal Disorders, the listing on the ClinicalTrials.gov website run by the U.S. National Institutes of Health and the description by the funder, the Canadian Institutes of Health Research.

Two doctors who perform FAI surgery say they are not aware of a North American or European way of shaving bone and repairing torn tissue using minimal access surgery known as arthroscopy.

Dr. Nikolaj Wolfson, who practises at Sutter Health California Pacific Medical Center in San Francisco, could not think of any differences between the two.

Dr. Derek Ochiai at the Nirschl Orthopedic Center in Arlington, Virginia, says there are some variations but they're not necessarily geographic.

"Certainly, there are several different ways to approach hip arthroscopy" he said. "I don't think I'd break it down by European versus North America."

All three patients say they were told they would get their surgery much faster if they took part in the study — a major consideration for a painful condition that can interfere with work and physical activity.

"He said, 'If you go in the study, you can probably get in quicker,'" said McBride. "It was like six months if you go in the study and a year if you don't."

The three were all under the impression bone would be reshaped if they took part in the study.

"I was going to have bone shaved down," said one patient who does not want to be named because he is still under Ayeni's care. "Mine was definitely going to be shaved."

But only half of the patients in the study are supposed to get bone shaving done. They are to be chosen at random without knowing which group they are in.

Ayeni says the other half get the joint washed out with saline and torn tissue repaired. Bhandari says tissue is rarely repaired and only when a surgeon couldn't ethically leave it alone. He has called the saline wash a placebo, while Ayeni denies it's sham surgery.

"It's not at all unreasonable for one surgeon to view a particular therapy closer to a 'placebo' while another has strong beliefs that the same therapy has a strong biological effect and is far from such a 'label,'" reads an earlier statement by McMaster, HHS, Bhandari and Ayeni.

"These are simply opinions that are part of the scientific debates that occur daily in research trials."

Another patient, who does not want to be identified because she works at McMaster and is also a student there, says she only recently found out bone wasn't shaved during her surgery in 2013.

"The bone remodelling was explained as what was going to solve the problem," she says. "My impression was that … there was going to be something done to my bone."

She says she made the decision not to have surgery on the other hip because she believed she had the full treatment and it didn't work. She has told other medical professionals exploring treatment options that she already had bone shaved. And she's paid out of pocket for physiotherapy trying to improve her symptoms.

"I don't know if what was done is what another doctor would have done," she says. "This is a nightmare."

jfrketich@thespec.com

905-526-3349 | @Jfrketich

'This is a nightmare': patient on differing accounts of surgical study's purpose

News Apr 01, 2016 by Joanna Frketich The Hamilton Spectator

Patients give vastly different accounts than the researchers of what is being studied in a Hamilton trial that has raised serious questions about informed consent.

Three patients give identical descriptions of what they say Dr. Olufemi Ayeni told them he was researching in the Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST), which to date has involved 54 people put under general anesthetic at McMaster University Medical Centre.

Their understanding of the study's aim bears zero resemblance to the contradictory explanations provided by principal investigators Ayeni and Dr. Mohit Bhandari.

"I'm curious," said patient Steve McBride, who had the surgery 18 months ago. "Was it really done, what was said was done?"

McMaster, HHS and the researchers did not respond Friday to questions about what patients are told, what the study is testing and why the descriptions are so different.

Instead they released a statement saying, "McMaster University and Hamilton Health Sciences recommend that any patient who has questions about their care, including medical procedures or surgery, should contact their physician."

It is not clear if any of the three patients who contacted The Spectator ended up in the pilot or ongoing surgical study at McMaster University and Hamilton Health Sciences.

But they say Ayeni attempted to recruit them during appointments about surgery for a painful condition where there is a mismatch of the ball and socket in the hip joint.

All three describe the study as testing the North American versus the European way of doing femoracetabular impingement (FAI) surgery.

"One (group) was going to be doing it the North American way and one was the European way and he's done both," said McBride. "He said, 'They're equally as good.'"

There is no reference to a North American versus a European way of performing the surgery in the patient consent form.

It is not mentioned in a number of published accounts of the study, including an article in the journal BMC Musculoskeletal Disorders, the listing on the ClinicalTrials.gov website run by the U.S. National Institutes of Health and the description by the funder, the Canadian Institutes of Health Research.

Two doctors who perform FAI surgery say they are not aware of a North American or European way of shaving bone and repairing torn tissue using minimal access surgery known as arthroscopy.

Dr. Nikolaj Wolfson, who practises at Sutter Health California Pacific Medical Center in San Francisco, could not think of any differences between the two.

Dr. Derek Ochiai at the Nirschl Orthopedic Center in Arlington, Virginia, says there are some variations but they're not necessarily geographic.

"Certainly, there are several different ways to approach hip arthroscopy" he said. "I don't think I'd break it down by European versus North America."

All three patients say they were told they would get their surgery much faster if they took part in the study — a major consideration for a painful condition that can interfere with work and physical activity.

"He said, 'If you go in the study, you can probably get in quicker,'" said McBride. "It was like six months if you go in the study and a year if you don't."

The three were all under the impression bone would be reshaped if they took part in the study.

"I was going to have bone shaved down," said one patient who does not want to be named because he is still under Ayeni's care. "Mine was definitely going to be shaved."

But only half of the patients in the study are supposed to get bone shaving done. They are to be chosen at random without knowing which group they are in.

Ayeni says the other half get the joint washed out with saline and torn tissue repaired. Bhandari says tissue is rarely repaired and only when a surgeon couldn't ethically leave it alone. He has called the saline wash a placebo, while Ayeni denies it's sham surgery.

"It's not at all unreasonable for one surgeon to view a particular therapy closer to a 'placebo' while another has strong beliefs that the same therapy has a strong biological effect and is far from such a 'label,'" reads an earlier statement by McMaster, HHS, Bhandari and Ayeni.

"These are simply opinions that are part of the scientific debates that occur daily in research trials."

Another patient, who does not want to be identified because she works at McMaster and is also a student there, says she only recently found out bone wasn't shaved during her surgery in 2013.

"The bone remodelling was explained as what was going to solve the problem," she says. "My impression was that … there was going to be something done to my bone."

She says she made the decision not to have surgery on the other hip because she believed she had the full treatment and it didn't work. She has told other medical professionals exploring treatment options that she already had bone shaved. And she's paid out of pocket for physiotherapy trying to improve her symptoms.

"I don't know if what was done is what another doctor would have done," she says. "This is a nightmare."

jfrketich@thespec.com

905-526-3349 | @Jfrketich

'This is a nightmare': patient on differing accounts of surgical study's purpose

News Apr 01, 2016 by Joanna Frketich The Hamilton Spectator

Patients give vastly different accounts than the researchers of what is being studied in a Hamilton trial that has raised serious questions about informed consent.

Three patients give identical descriptions of what they say Dr. Olufemi Ayeni told them he was researching in the Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST), which to date has involved 54 people put under general anesthetic at McMaster University Medical Centre.

Their understanding of the study's aim bears zero resemblance to the contradictory explanations provided by principal investigators Ayeni and Dr. Mohit Bhandari.

"I'm curious," said patient Steve McBride, who had the surgery 18 months ago. "Was it really done, what was said was done?"

McMaster, HHS and the researchers did not respond Friday to questions about what patients are told, what the study is testing and why the descriptions are so different.

Instead they released a statement saying, "McMaster University and Hamilton Health Sciences recommend that any patient who has questions about their care, including medical procedures or surgery, should contact their physician."

It is not clear if any of the three patients who contacted The Spectator ended up in the pilot or ongoing surgical study at McMaster University and Hamilton Health Sciences.

But they say Ayeni attempted to recruit them during appointments about surgery for a painful condition where there is a mismatch of the ball and socket in the hip joint.

All three describe the study as testing the North American versus the European way of doing femoracetabular impingement (FAI) surgery.

"One (group) was going to be doing it the North American way and one was the European way and he's done both," said McBride. "He said, 'They're equally as good.'"

There is no reference to a North American versus a European way of performing the surgery in the patient consent form.

It is not mentioned in a number of published accounts of the study, including an article in the journal BMC Musculoskeletal Disorders, the listing on the ClinicalTrials.gov website run by the U.S. National Institutes of Health and the description by the funder, the Canadian Institutes of Health Research.

Two doctors who perform FAI surgery say they are not aware of a North American or European way of shaving bone and repairing torn tissue using minimal access surgery known as arthroscopy.

Dr. Nikolaj Wolfson, who practises at Sutter Health California Pacific Medical Center in San Francisco, could not think of any differences between the two.

Dr. Derek Ochiai at the Nirschl Orthopedic Center in Arlington, Virginia, says there are some variations but they're not necessarily geographic.

"Certainly, there are several different ways to approach hip arthroscopy" he said. "I don't think I'd break it down by European versus North America."

All three patients say they were told they would get their surgery much faster if they took part in the study — a major consideration for a painful condition that can interfere with work and physical activity.

"He said, 'If you go in the study, you can probably get in quicker,'" said McBride. "It was like six months if you go in the study and a year if you don't."

The three were all under the impression bone would be reshaped if they took part in the study.

"I was going to have bone shaved down," said one patient who does not want to be named because he is still under Ayeni's care. "Mine was definitely going to be shaved."

But only half of the patients in the study are supposed to get bone shaving done. They are to be chosen at random without knowing which group they are in.

Ayeni says the other half get the joint washed out with saline and torn tissue repaired. Bhandari says tissue is rarely repaired and only when a surgeon couldn't ethically leave it alone. He has called the saline wash a placebo, while Ayeni denies it's sham surgery.

"It's not at all unreasonable for one surgeon to view a particular therapy closer to a 'placebo' while another has strong beliefs that the same therapy has a strong biological effect and is far from such a 'label,'" reads an earlier statement by McMaster, HHS, Bhandari and Ayeni.

"These are simply opinions that are part of the scientific debates that occur daily in research trials."

Another patient, who does not want to be identified because she works at McMaster and is also a student there, says she only recently found out bone wasn't shaved during her surgery in 2013.

"The bone remodelling was explained as what was going to solve the problem," she says. "My impression was that … there was going to be something done to my bone."

She says she made the decision not to have surgery on the other hip because she believed she had the full treatment and it didn't work. She has told other medical professionals exploring treatment options that she already had bone shaved. And she's paid out of pocket for physiotherapy trying to improve her symptoms.

"I don't know if what was done is what another doctor would have done," she says. "This is a nightmare."

jfrketich@thespec.com

905-526-3349 | @Jfrketich