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Safety in Health Care: An Essential Pillar of Quality
Each year, 40,000 to 98,000 deaths occur due to medical errors.1 The Harvard Medical Practice Study (HMPS), published in 1991, found that 3.7% of hospitalized patients were harmed by adverse events and 1% were harmed by adverse events due to negligence.2 The latest HMPS showed that, despite significant improvements in patient safety over the past 3 decades, patient safety challenges persist. This study found that inpatient care leads to harm in nearly a quarter of patients, and that 1 in 4 of these adverse events are preventable.3
Since the first HMPS study was published, efforts to improve patient safety have focused on identifying causes of medical error and the design and implementation of interventions to mitigate errors. Factors contributing to medical errors have been well documented: the complexity of care delivery from inpatient to outpatient settings, with transitions of care and extensive use of medications; multiple comorbidities; and the fragmentation of care across multiple systems and specialties. Although most errors are related to process or system failure, accountability of each practitioner and clinician is essential to promoting a culture of safety. Many medical errors are preventable through multifaceted approaches employed throughout the phases of the care,4 with medication errors, both prescribing and administration, and diagnostic and treatment errors encompassing most risk prevention areas. Broadly, safety efforts should emphasize building a culture of safety where all safety events are reported, including near-miss events.
Two articles in this issue of JCOM address key elements of patient safety: building a safety culture and diagnostic error. Merchant et al5 report on an initiative designed to promote a safety culture by recognizing and rewarding staff who identify and report near misses. The tiered awards program they designed led to significantly increased staff participation in the safety awards nomination process and was associated with increased reporting of actual and close-call events and greater attendance at monthly safety forums. Goyal et al,6 noting that diagnostic error rates in hospitalized patients remain unacceptably high, provide a concise update on diagnostic error among inpatients, focusing on issues related to defining and measuring diagnostic errors and current strategies to improve diagnostic safety in hospitalized patients. In a third article, Sathi et al report on efforts to teach quality improvement (QI) methods to internal medicine trainees; their project increased residents’ knowledge of their patient panels and comfort with QI approaches and led to improved patient outcomes.
Major progress has been made to improve health care safety since the first HMPS was published. However, the latest HMPS shows that patient safety efforts must continue, given the persistent risk for patient harm in the current health care delivery system. Safety, along with clear accountability for identifying, reporting, and addressing errors, should be a top priority for health care systems throughout the preventive, diagnostic, and therapeutic phases of care.
Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]
1. Clancy C, Munier W, Brady J. National healthcare quality report. Agency for Healthcare Research and Quality; 2013.
2. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324(6):370-376. doi:10.1056/NEJM199102073240604
3. Bates DW, Levine DM, Salmasian H, et al. The safety of inpatient health care. N Engl J Med. 2023;388(2):142-153. doi:10.1056/NEJMsa2206117
4. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events: implications for prevention. JAMA. 1995;274(1):29-34.
5. Merchant NB, O’Neal J, Murray JS. Development of a safety awards program at a Veterans Affairs health care system: a quality improvement initiative. J Clin Outcome Manag. 2023;30(1):9-16. doi:10.12788/jcom.0120
6. Goyal A, Martin-Doyle W, Dalal AK. Diagnostic errors in hospitalized patients. J Clin Outcome Manag. 2023;30(1):17-27. doi:10.12788/jcom.0121
7. Sathi K, Huang KTL, Chandler DM, et al. Teaching quality improvement to internal medicine residents to address patient care gaps in ambulatory quality metrics. J Clin Outcome Manag. 2023;30(1):1-6.doi:10.12788/jcom.0119
Each year, 40,000 to 98,000 deaths occur due to medical errors.1 The Harvard Medical Practice Study (HMPS), published in 1991, found that 3.7% of hospitalized patients were harmed by adverse events and 1% were harmed by adverse events due to negligence.2 The latest HMPS showed that, despite significant improvements in patient safety over the past 3 decades, patient safety challenges persist. This study found that inpatient care leads to harm in nearly a quarter of patients, and that 1 in 4 of these adverse events are preventable.3
Since the first HMPS study was published, efforts to improve patient safety have focused on identifying causes of medical error and the design and implementation of interventions to mitigate errors. Factors contributing to medical errors have been well documented: the complexity of care delivery from inpatient to outpatient settings, with transitions of care and extensive use of medications; multiple comorbidities; and the fragmentation of care across multiple systems and specialties. Although most errors are related to process or system failure, accountability of each practitioner and clinician is essential to promoting a culture of safety. Many medical errors are preventable through multifaceted approaches employed throughout the phases of the care,4 with medication errors, both prescribing and administration, and diagnostic and treatment errors encompassing most risk prevention areas. Broadly, safety efforts should emphasize building a culture of safety where all safety events are reported, including near-miss events.
Two articles in this issue of JCOM address key elements of patient safety: building a safety culture and diagnostic error. Merchant et al5 report on an initiative designed to promote a safety culture by recognizing and rewarding staff who identify and report near misses. The tiered awards program they designed led to significantly increased staff participation in the safety awards nomination process and was associated with increased reporting of actual and close-call events and greater attendance at monthly safety forums. Goyal et al,6 noting that diagnostic error rates in hospitalized patients remain unacceptably high, provide a concise update on diagnostic error among inpatients, focusing on issues related to defining and measuring diagnostic errors and current strategies to improve diagnostic safety in hospitalized patients. In a third article, Sathi et al report on efforts to teach quality improvement (QI) methods to internal medicine trainees; their project increased residents’ knowledge of their patient panels and comfort with QI approaches and led to improved patient outcomes.
Major progress has been made to improve health care safety since the first HMPS was published. However, the latest HMPS shows that patient safety efforts must continue, given the persistent risk for patient harm in the current health care delivery system. Safety, along with clear accountability for identifying, reporting, and addressing errors, should be a top priority for health care systems throughout the preventive, diagnostic, and therapeutic phases of care.
Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]
Each year, 40,000 to 98,000 deaths occur due to medical errors.1 The Harvard Medical Practice Study (HMPS), published in 1991, found that 3.7% of hospitalized patients were harmed by adverse events and 1% were harmed by adverse events due to negligence.2 The latest HMPS showed that, despite significant improvements in patient safety over the past 3 decades, patient safety challenges persist. This study found that inpatient care leads to harm in nearly a quarter of patients, and that 1 in 4 of these adverse events are preventable.3
Since the first HMPS study was published, efforts to improve patient safety have focused on identifying causes of medical error and the design and implementation of interventions to mitigate errors. Factors contributing to medical errors have been well documented: the complexity of care delivery from inpatient to outpatient settings, with transitions of care and extensive use of medications; multiple comorbidities; and the fragmentation of care across multiple systems and specialties. Although most errors are related to process or system failure, accountability of each practitioner and clinician is essential to promoting a culture of safety. Many medical errors are preventable through multifaceted approaches employed throughout the phases of the care,4 with medication errors, both prescribing and administration, and diagnostic and treatment errors encompassing most risk prevention areas. Broadly, safety efforts should emphasize building a culture of safety where all safety events are reported, including near-miss events.
Two articles in this issue of JCOM address key elements of patient safety: building a safety culture and diagnostic error. Merchant et al5 report on an initiative designed to promote a safety culture by recognizing and rewarding staff who identify and report near misses. The tiered awards program they designed led to significantly increased staff participation in the safety awards nomination process and was associated with increased reporting of actual and close-call events and greater attendance at monthly safety forums. Goyal et al,6 noting that diagnostic error rates in hospitalized patients remain unacceptably high, provide a concise update on diagnostic error among inpatients, focusing on issues related to defining and measuring diagnostic errors and current strategies to improve diagnostic safety in hospitalized patients. In a third article, Sathi et al report on efforts to teach quality improvement (QI) methods to internal medicine trainees; their project increased residents’ knowledge of their patient panels and comfort with QI approaches and led to improved patient outcomes.
Major progress has been made to improve health care safety since the first HMPS was published. However, the latest HMPS shows that patient safety efforts must continue, given the persistent risk for patient harm in the current health care delivery system. Safety, along with clear accountability for identifying, reporting, and addressing errors, should be a top priority for health care systems throughout the preventive, diagnostic, and therapeutic phases of care.
Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]
1. Clancy C, Munier W, Brady J. National healthcare quality report. Agency for Healthcare Research and Quality; 2013.
2. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324(6):370-376. doi:10.1056/NEJM199102073240604
3. Bates DW, Levine DM, Salmasian H, et al. The safety of inpatient health care. N Engl J Med. 2023;388(2):142-153. doi:10.1056/NEJMsa2206117
4. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events: implications for prevention. JAMA. 1995;274(1):29-34.
5. Merchant NB, O’Neal J, Murray JS. Development of a safety awards program at a Veterans Affairs health care system: a quality improvement initiative. J Clin Outcome Manag. 2023;30(1):9-16. doi:10.12788/jcom.0120
6. Goyal A, Martin-Doyle W, Dalal AK. Diagnostic errors in hospitalized patients. J Clin Outcome Manag. 2023;30(1):17-27. doi:10.12788/jcom.0121
7. Sathi K, Huang KTL, Chandler DM, et al. Teaching quality improvement to internal medicine residents to address patient care gaps in ambulatory quality metrics. J Clin Outcome Manag. 2023;30(1):1-6.doi:10.12788/jcom.0119
1. Clancy C, Munier W, Brady J. National healthcare quality report. Agency for Healthcare Research and Quality; 2013.
2. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324(6):370-376. doi:10.1056/NEJM199102073240604
3. Bates DW, Levine DM, Salmasian H, et al. The safety of inpatient health care. N Engl J Med. 2023;388(2):142-153. doi:10.1056/NEJMsa2206117
4. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events: implications for prevention. JAMA. 1995;274(1):29-34.
5. Merchant NB, O’Neal J, Murray JS. Development of a safety awards program at a Veterans Affairs health care system: a quality improvement initiative. J Clin Outcome Manag. 2023;30(1):9-16. doi:10.12788/jcom.0120
6. Goyal A, Martin-Doyle W, Dalal AK. Diagnostic errors in hospitalized patients. J Clin Outcome Manag. 2023;30(1):17-27. doi:10.12788/jcom.0121
7. Sathi K, Huang KTL, Chandler DM, et al. Teaching quality improvement to internal medicine residents to address patient care gaps in ambulatory quality metrics. J Clin Outcome Manag. 2023;30(1):1-6.doi:10.12788/jcom.0119
A patient named ‘Settle’ decides to sue instead
On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.
Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.
Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.
Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.
Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.
His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.
Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.
Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.
Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”
His suit seeks not only compensatory damages and other relief but also punitive damages.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article originally appeared on Medscape.com.
On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.
Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.
Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.
Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.
Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.
His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.
Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.
Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.
Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”
His suit seeks not only compensatory damages and other relief but also punitive damages.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article originally appeared on Medscape.com.
On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.
Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.
Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.
Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.
Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.
His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.
Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.
Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.
Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”
His suit seeks not only compensatory damages and other relief but also punitive damages.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article originally appeared on Medscape.com.
Oncologist to insurer: ‘This denial will not stand’
“Is this really the hill you want to die on?” asked Rebecca Shatsky, MD, a medical oncologist at the University of California, San Diego.
It was Nov. 18 and Dr. Shatsky was on the phone with a retired oncologist working for the health insurance company Premera Blue Cross.
Dr. Shatsky was appealing a prior authorization denial for pembrolizumab (Keytruda) to treat her patient with stage IIIc triple-negative breast cancer (TNBC). She hoped the peer-to-peer would reverse the denial. The Food and Drug Administration had approved the immunotherapy for people with high-risk TNBC both in the neoadjuvant setting alongside chemotherapy and, in her patient’s case, as a single-agent adjuvant treatment based on data from the KEYNOTE 522 trial.
In the peer-to-peer, Dr. Shatsky laid out the evidence, but she could tell the physician wasn’t going to budge.
When she pressed him further, asking why he was denying potentially lifesaving care for her patient, he said the data on whether patients really need adjuvant pembrolizumab were not clear yet.
“The man – who was not a breast oncologist – was essentially mansplaining breast oncology to me,” she said in an interview. “I don’t need a nonexpert giving me their misinterpretation of the data.”
Dr. Shatsky informed him that this decision would not stand. She would be escalating the claim.
“I’m not going to let you get in way of my patient’s survival,” Dr. Shatsky told the physician during the peer-to-peer. “We have one shot to cure this, and if we don’t do it now, patients’ average lifespan is 17 months.”
The conversation turned a few heads in her office.
“My whole office stopped and stared. But then they clapped after they realized why I was yelling,” she tweeted later that night.
She continued: “@premera picked the wrong oncologist to mess with today. I will not be letting this go. This denial. Will. Not. Stand. An insurance company should not get to tell me how to practice medicine when Phase III RCT data and @NCCN + @ASCO guideline support my decision!”
A spokesperson for Premera said in a statement that, “while we did see many of the details about the case were posted to Twitter, we cannot comment on the specifics you noted due to privacy policies.”
The spokesperson explained that Premera has “the same goal as our provider partners: ensure our members have access to quality health care,” noting that prior authorization helps health plans evaluate the medical necessity and safety of health care services given that “15%-30% of care is unnecessary.”
“We also understand that providers may not agree with our decisions, which is why we have a robust appeals process,” the spokesperson said, suggesting Dr. Shatsky could have appealed the decision a second time.
And “if the member or provider still disagrees with Premera’s coverage decision after the initial appeal, providers can request review by a medical expert outside Premera who works for an independent review organization,” and the company “will pay for” and “abide by” that decision, the spokesperson added.
The Twitter storm
After Dr. Shatsky tweeted about her experience with Premera, she received a flood of support from the Twitterverse. The thread garnered tens of thousands of likes and hundreds of comments offering support and advice.
Several people suggested asking Merck for help accessing the drug. But Dr. Shatsky said no, “I’m tired of laying down and letting [insurance companies] win. It IS worth fighting for.”
The next morning, Dr. Shatsky got a call. It was the vice president of medical management at Premera.
“We’ve talked again, and we’ll give you the drug,” Dr. Shatsky recalled the Premera vice president saying.
The next day, Monday morning, Dr. Shatsky’s patient received her first infusion of pembrolizumab.
Although relieved, Dr. Shatsky noted that it wasn’t until she posted her experience to Twitter that Premera seemed to take notice.
Plus, “an oncologist without a strong social media following may not have gotten care approved and that’s not how medicine should work,” said Dr. Anderson, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora.
Tatiana Prowell, MD, expressed similar concerns in a Nov. 20 tweet: “And sadly, the patients with cancer & an even busier, more exhausted doctor who doesn’t have a big [reach] on social media will be denied appropriate care. And that’s bank for insurers.”
But, Dr. Prowell noted sarcastically: “At least a patient with cancer had her care delayed & a dedicated OncTwitter colleague’s Physician Burnout was exacerbated.”
In this case, the prior authorization process took about a week – requiring an initial prior authorization request, an appeal after the request was denied, a peer-to-peer resulting in a second denial, and finally a tweet and a phone call from a top executive at the company.
In fact, these delays have become so common that Dr. Shatsky needs to anticipate and incorporate likely delays into her workflow.
“I learn which drugs will take a long time to get prior authorization for and then plan enough time so that my patient’s care is hopefully not delayed,” Dr. Shatsky said. “It should not be so hard to get appropriate and time-sensitive care for our patients.”
A version of this article first appeared on Medscape.com.
“Is this really the hill you want to die on?” asked Rebecca Shatsky, MD, a medical oncologist at the University of California, San Diego.
It was Nov. 18 and Dr. Shatsky was on the phone with a retired oncologist working for the health insurance company Premera Blue Cross.
Dr. Shatsky was appealing a prior authorization denial for pembrolizumab (Keytruda) to treat her patient with stage IIIc triple-negative breast cancer (TNBC). She hoped the peer-to-peer would reverse the denial. The Food and Drug Administration had approved the immunotherapy for people with high-risk TNBC both in the neoadjuvant setting alongside chemotherapy and, in her patient’s case, as a single-agent adjuvant treatment based on data from the KEYNOTE 522 trial.
In the peer-to-peer, Dr. Shatsky laid out the evidence, but she could tell the physician wasn’t going to budge.
When she pressed him further, asking why he was denying potentially lifesaving care for her patient, he said the data on whether patients really need adjuvant pembrolizumab were not clear yet.
“The man – who was not a breast oncologist – was essentially mansplaining breast oncology to me,” she said in an interview. “I don’t need a nonexpert giving me their misinterpretation of the data.”
Dr. Shatsky informed him that this decision would not stand. She would be escalating the claim.
“I’m not going to let you get in way of my patient’s survival,” Dr. Shatsky told the physician during the peer-to-peer. “We have one shot to cure this, and if we don’t do it now, patients’ average lifespan is 17 months.”
The conversation turned a few heads in her office.
“My whole office stopped and stared. But then they clapped after they realized why I was yelling,” she tweeted later that night.
She continued: “@premera picked the wrong oncologist to mess with today. I will not be letting this go. This denial. Will. Not. Stand. An insurance company should not get to tell me how to practice medicine when Phase III RCT data and @NCCN + @ASCO guideline support my decision!”
A spokesperson for Premera said in a statement that, “while we did see many of the details about the case were posted to Twitter, we cannot comment on the specifics you noted due to privacy policies.”
The spokesperson explained that Premera has “the same goal as our provider partners: ensure our members have access to quality health care,” noting that prior authorization helps health plans evaluate the medical necessity and safety of health care services given that “15%-30% of care is unnecessary.”
“We also understand that providers may not agree with our decisions, which is why we have a robust appeals process,” the spokesperson said, suggesting Dr. Shatsky could have appealed the decision a second time.
And “if the member or provider still disagrees with Premera’s coverage decision after the initial appeal, providers can request review by a medical expert outside Premera who works for an independent review organization,” and the company “will pay for” and “abide by” that decision, the spokesperson added.
The Twitter storm
After Dr. Shatsky tweeted about her experience with Premera, she received a flood of support from the Twitterverse. The thread garnered tens of thousands of likes and hundreds of comments offering support and advice.
Several people suggested asking Merck for help accessing the drug. But Dr. Shatsky said no, “I’m tired of laying down and letting [insurance companies] win. It IS worth fighting for.”
The next morning, Dr. Shatsky got a call. It was the vice president of medical management at Premera.
“We’ve talked again, and we’ll give you the drug,” Dr. Shatsky recalled the Premera vice president saying.
The next day, Monday morning, Dr. Shatsky’s patient received her first infusion of pembrolizumab.
Although relieved, Dr. Shatsky noted that it wasn’t until she posted her experience to Twitter that Premera seemed to take notice.
Plus, “an oncologist without a strong social media following may not have gotten care approved and that’s not how medicine should work,” said Dr. Anderson, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora.
Tatiana Prowell, MD, expressed similar concerns in a Nov. 20 tweet: “And sadly, the patients with cancer & an even busier, more exhausted doctor who doesn’t have a big [reach] on social media will be denied appropriate care. And that’s bank for insurers.”
But, Dr. Prowell noted sarcastically: “At least a patient with cancer had her care delayed & a dedicated OncTwitter colleague’s Physician Burnout was exacerbated.”
In this case, the prior authorization process took about a week – requiring an initial prior authorization request, an appeal after the request was denied, a peer-to-peer resulting in a second denial, and finally a tweet and a phone call from a top executive at the company.
In fact, these delays have become so common that Dr. Shatsky needs to anticipate and incorporate likely delays into her workflow.
“I learn which drugs will take a long time to get prior authorization for and then plan enough time so that my patient’s care is hopefully not delayed,” Dr. Shatsky said. “It should not be so hard to get appropriate and time-sensitive care for our patients.”
A version of this article first appeared on Medscape.com.
“Is this really the hill you want to die on?” asked Rebecca Shatsky, MD, a medical oncologist at the University of California, San Diego.
It was Nov. 18 and Dr. Shatsky was on the phone with a retired oncologist working for the health insurance company Premera Blue Cross.
Dr. Shatsky was appealing a prior authorization denial for pembrolizumab (Keytruda) to treat her patient with stage IIIc triple-negative breast cancer (TNBC). She hoped the peer-to-peer would reverse the denial. The Food and Drug Administration had approved the immunotherapy for people with high-risk TNBC both in the neoadjuvant setting alongside chemotherapy and, in her patient’s case, as a single-agent adjuvant treatment based on data from the KEYNOTE 522 trial.
In the peer-to-peer, Dr. Shatsky laid out the evidence, but she could tell the physician wasn’t going to budge.
When she pressed him further, asking why he was denying potentially lifesaving care for her patient, he said the data on whether patients really need adjuvant pembrolizumab were not clear yet.
“The man – who was not a breast oncologist – was essentially mansplaining breast oncology to me,” she said in an interview. “I don’t need a nonexpert giving me their misinterpretation of the data.”
Dr. Shatsky informed him that this decision would not stand. She would be escalating the claim.
“I’m not going to let you get in way of my patient’s survival,” Dr. Shatsky told the physician during the peer-to-peer. “We have one shot to cure this, and if we don’t do it now, patients’ average lifespan is 17 months.”
The conversation turned a few heads in her office.
“My whole office stopped and stared. But then they clapped after they realized why I was yelling,” she tweeted later that night.
She continued: “@premera picked the wrong oncologist to mess with today. I will not be letting this go. This denial. Will. Not. Stand. An insurance company should not get to tell me how to practice medicine when Phase III RCT data and @NCCN + @ASCO guideline support my decision!”
A spokesperson for Premera said in a statement that, “while we did see many of the details about the case were posted to Twitter, we cannot comment on the specifics you noted due to privacy policies.”
The spokesperson explained that Premera has “the same goal as our provider partners: ensure our members have access to quality health care,” noting that prior authorization helps health plans evaluate the medical necessity and safety of health care services given that “15%-30% of care is unnecessary.”
“We also understand that providers may not agree with our decisions, which is why we have a robust appeals process,” the spokesperson said, suggesting Dr. Shatsky could have appealed the decision a second time.
And “if the member or provider still disagrees with Premera’s coverage decision after the initial appeal, providers can request review by a medical expert outside Premera who works for an independent review organization,” and the company “will pay for” and “abide by” that decision, the spokesperson added.
The Twitter storm
After Dr. Shatsky tweeted about her experience with Premera, she received a flood of support from the Twitterverse. The thread garnered tens of thousands of likes and hundreds of comments offering support and advice.
Several people suggested asking Merck for help accessing the drug. But Dr. Shatsky said no, “I’m tired of laying down and letting [insurance companies] win. It IS worth fighting for.”
The next morning, Dr. Shatsky got a call. It was the vice president of medical management at Premera.
“We’ve talked again, and we’ll give you the drug,” Dr. Shatsky recalled the Premera vice president saying.
The next day, Monday morning, Dr. Shatsky’s patient received her first infusion of pembrolizumab.
Although relieved, Dr. Shatsky noted that it wasn’t until she posted her experience to Twitter that Premera seemed to take notice.
Plus, “an oncologist without a strong social media following may not have gotten care approved and that’s not how medicine should work,” said Dr. Anderson, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora.
Tatiana Prowell, MD, expressed similar concerns in a Nov. 20 tweet: “And sadly, the patients with cancer & an even busier, more exhausted doctor who doesn’t have a big [reach] on social media will be denied appropriate care. And that’s bank for insurers.”
But, Dr. Prowell noted sarcastically: “At least a patient with cancer had her care delayed & a dedicated OncTwitter colleague’s Physician Burnout was exacerbated.”
In this case, the prior authorization process took about a week – requiring an initial prior authorization request, an appeal after the request was denied, a peer-to-peer resulting in a second denial, and finally a tweet and a phone call from a top executive at the company.
In fact, these delays have become so common that Dr. Shatsky needs to anticipate and incorporate likely delays into her workflow.
“I learn which drugs will take a long time to get prior authorization for and then plan enough time so that my patient’s care is hopefully not delayed,” Dr. Shatsky said. “It should not be so hard to get appropriate and time-sensitive care for our patients.”
A version of this article first appeared on Medscape.com.
Not all white coats are doctors: Why titles are important at the doctor’s office
says Cyndy Flores, a physician assistant (PA) in the emergency department at Vituity, Emeryville, Calif. “Sometimes, I can go through a complete history and physical, explain a treatment plan, and perform a procedure, and [the patient] will say, ‘Thank you, doctor.’ ”
“I always come back and say, ‘You’re very welcome, but my name is Cyndy, and I’m the PA.’ ”
Ms. Flores is used to patients calling her “doctor” when she greets them. She typically offers a quick correction and moves on with the appointment.
With 355,000 nurse practitioners (NPs) and 149,000 certified PAs practicing in the United States, it’s more common than ever for health care providers who don’t go by the title “doctor” to diagnose and treat patients.
A recent report, Evolving Scope of Practice, found that more than 70% of physicians were “somewhat satisfied to very satisfied” with patient treatment by PAs and NPs.
But for patients, having a health care team that includes physicians, NPs, and PAs can be confusing. Additionally, it creates a need for education about their correct titles and roles in patient care.
“It’s really important for patients to understand who is taking care of them,” Ms. Flores says.
Education starts in your practice
Educating patients about the roles of different providers on their health care team starts long before patients enter the exam room, Ms. Flores explains.
Some patients may not understand the difference, some may just forget because they’re used to calling all providers doctors, and others may find it awkward to use a provider’s first name or not know the respectful way to address an NP or a PA.
Practices can help by listing the names and biographies of the health care team on the clinic website. In addition, when patients call for an appointment, Ms. Flores believes front desk staff can reinforce that information. When offering appointments with a physician, NP, or PA, clearly use the practitioner’s title and reiterate it throughout the conversation. For example, “Would you like to see our nurse practitioner, Alice Smith, next week?” or “So, our physician assistant Mrs. Jones will see you Friday at 3 PM.”
The report also found that 76% of patients expressed a preference to see a physician over a PA, and 71% expressed a preference to see a physician over an NP, but offering appointments with nonphysician providers is part of the education process.
“Some families are super savvy and know the differences between nurse practitioners, physician assistants, and doctors, and ... there are families who don’t understand those titles, [and] we need to explain what they do in our practice,” adds Nicole Aaronson, MD, MBA, attending surgeon at Nemours Children’s Health of Delaware. Dr. Aaronson believes there’s an opportunity for educating patients when speaking about all the available providers they may see.
Hanging posters or using brochures in the clinic or hospital is another effective way to reinforce the roles of various providers on the care team. Include biographies and educational information on practice materials and video programs running in the waiting room.
“Patients mean it [calling everyone doctor] as a way to respectfully address the nurse practitioner or physician assistant rather than meaning it as a denigration of the physician,” Dr. Aaronson says. “But everyone appreciates being called by the correct title.”
Helping patients understand the members of their care team and the correct titles to use for those health care professionals could also help patients feel more confident about their health care experience.
“Patients really like knowing that there are specialists in each of the areas taking care of them,” Ms. Flores says. “I think that conveys a feeling of trust in your provider.”
Not everyone is a doctor
Even when PAs and NPs remind patients of their roles and reinforce the use of their preferred names, there will still be patients who continue referring to their nonphysician provider as “doctor.”
“There’s a perception that anyone who walks into a room with a stethoscope is your doctor,” says Graig Straus, DNP, an NP and president and CEO of Rockland Urgent Care Family Health NP, P.C., West Haverstraw, N.Y. “You do get a little bit of burnout correcting people all the time.”
Dr. Straus, who earned his doctorate in nursing practice, notes that patients using the honorific with him aren’t incorrect, but he still educates them on his role within the health care team.
“NPs and PAs have a valuable role to play independently and in concert with the physician,” Dr. Aaronson says. This understanding is essential, as states consider expanding treatment abilities for NPs and PAs.
NPs have expanded treatment abilities or full practice authority in almost half the states, and 31% of the physicians surveyed agreed that NPs should have expanded treatment abilities.
An estimated 1 in 5 states characterizes the physician-PA relationship as collaborative, not supervisory, according to the American Academy of Physician Associates. At the same time, only 39% of physicians surveyed said they favored this trend.
“Patients need great quality care, and there are many different types of providers that can provide that care as part of the team,” Ms. Flores says. “When you have a team taking care of a patient, that patient [gets] the best care possible – and ... that’s why we went into medicine: to deliver high-quality, compassionate care to our patients, and we should all be in this together.”
When practices do their part explaining who is and isn’t a doctor and what each provider’s title and role is and what to call them, and everyone reinforces it, health care becomes not only more manageable for patients to traverse but easier to understand, leading to a better experience.
A version of this article first appeared on Medscape.com.
says Cyndy Flores, a physician assistant (PA) in the emergency department at Vituity, Emeryville, Calif. “Sometimes, I can go through a complete history and physical, explain a treatment plan, and perform a procedure, and [the patient] will say, ‘Thank you, doctor.’ ”
“I always come back and say, ‘You’re very welcome, but my name is Cyndy, and I’m the PA.’ ”
Ms. Flores is used to patients calling her “doctor” when she greets them. She typically offers a quick correction and moves on with the appointment.
With 355,000 nurse practitioners (NPs) and 149,000 certified PAs practicing in the United States, it’s more common than ever for health care providers who don’t go by the title “doctor” to diagnose and treat patients.
A recent report, Evolving Scope of Practice, found that more than 70% of physicians were “somewhat satisfied to very satisfied” with patient treatment by PAs and NPs.
But for patients, having a health care team that includes physicians, NPs, and PAs can be confusing. Additionally, it creates a need for education about their correct titles and roles in patient care.
“It’s really important for patients to understand who is taking care of them,” Ms. Flores says.
Education starts in your practice
Educating patients about the roles of different providers on their health care team starts long before patients enter the exam room, Ms. Flores explains.
Some patients may not understand the difference, some may just forget because they’re used to calling all providers doctors, and others may find it awkward to use a provider’s first name or not know the respectful way to address an NP or a PA.
Practices can help by listing the names and biographies of the health care team on the clinic website. In addition, when patients call for an appointment, Ms. Flores believes front desk staff can reinforce that information. When offering appointments with a physician, NP, or PA, clearly use the practitioner’s title and reiterate it throughout the conversation. For example, “Would you like to see our nurse practitioner, Alice Smith, next week?” or “So, our physician assistant Mrs. Jones will see you Friday at 3 PM.”
The report also found that 76% of patients expressed a preference to see a physician over a PA, and 71% expressed a preference to see a physician over an NP, but offering appointments with nonphysician providers is part of the education process.
“Some families are super savvy and know the differences between nurse practitioners, physician assistants, and doctors, and ... there are families who don’t understand those titles, [and] we need to explain what they do in our practice,” adds Nicole Aaronson, MD, MBA, attending surgeon at Nemours Children’s Health of Delaware. Dr. Aaronson believes there’s an opportunity for educating patients when speaking about all the available providers they may see.
Hanging posters or using brochures in the clinic or hospital is another effective way to reinforce the roles of various providers on the care team. Include biographies and educational information on practice materials and video programs running in the waiting room.
“Patients mean it [calling everyone doctor] as a way to respectfully address the nurse practitioner or physician assistant rather than meaning it as a denigration of the physician,” Dr. Aaronson says. “But everyone appreciates being called by the correct title.”
Helping patients understand the members of their care team and the correct titles to use for those health care professionals could also help patients feel more confident about their health care experience.
“Patients really like knowing that there are specialists in each of the areas taking care of them,” Ms. Flores says. “I think that conveys a feeling of trust in your provider.”
Not everyone is a doctor
Even when PAs and NPs remind patients of their roles and reinforce the use of their preferred names, there will still be patients who continue referring to their nonphysician provider as “doctor.”
“There’s a perception that anyone who walks into a room with a stethoscope is your doctor,” says Graig Straus, DNP, an NP and president and CEO of Rockland Urgent Care Family Health NP, P.C., West Haverstraw, N.Y. “You do get a little bit of burnout correcting people all the time.”
Dr. Straus, who earned his doctorate in nursing practice, notes that patients using the honorific with him aren’t incorrect, but he still educates them on his role within the health care team.
“NPs and PAs have a valuable role to play independently and in concert with the physician,” Dr. Aaronson says. This understanding is essential, as states consider expanding treatment abilities for NPs and PAs.
NPs have expanded treatment abilities or full practice authority in almost half the states, and 31% of the physicians surveyed agreed that NPs should have expanded treatment abilities.
An estimated 1 in 5 states characterizes the physician-PA relationship as collaborative, not supervisory, according to the American Academy of Physician Associates. At the same time, only 39% of physicians surveyed said they favored this trend.
“Patients need great quality care, and there are many different types of providers that can provide that care as part of the team,” Ms. Flores says. “When you have a team taking care of a patient, that patient [gets] the best care possible – and ... that’s why we went into medicine: to deliver high-quality, compassionate care to our patients, and we should all be in this together.”
When practices do their part explaining who is and isn’t a doctor and what each provider’s title and role is and what to call them, and everyone reinforces it, health care becomes not only more manageable for patients to traverse but easier to understand, leading to a better experience.
A version of this article first appeared on Medscape.com.
says Cyndy Flores, a physician assistant (PA) in the emergency department at Vituity, Emeryville, Calif. “Sometimes, I can go through a complete history and physical, explain a treatment plan, and perform a procedure, and [the patient] will say, ‘Thank you, doctor.’ ”
“I always come back and say, ‘You’re very welcome, but my name is Cyndy, and I’m the PA.’ ”
Ms. Flores is used to patients calling her “doctor” when she greets them. She typically offers a quick correction and moves on with the appointment.
With 355,000 nurse practitioners (NPs) and 149,000 certified PAs practicing in the United States, it’s more common than ever for health care providers who don’t go by the title “doctor” to diagnose and treat patients.
A recent report, Evolving Scope of Practice, found that more than 70% of physicians were “somewhat satisfied to very satisfied” with patient treatment by PAs and NPs.
But for patients, having a health care team that includes physicians, NPs, and PAs can be confusing. Additionally, it creates a need for education about their correct titles and roles in patient care.
“It’s really important for patients to understand who is taking care of them,” Ms. Flores says.
Education starts in your practice
Educating patients about the roles of different providers on their health care team starts long before patients enter the exam room, Ms. Flores explains.
Some patients may not understand the difference, some may just forget because they’re used to calling all providers doctors, and others may find it awkward to use a provider’s first name or not know the respectful way to address an NP or a PA.
Practices can help by listing the names and biographies of the health care team on the clinic website. In addition, when patients call for an appointment, Ms. Flores believes front desk staff can reinforce that information. When offering appointments with a physician, NP, or PA, clearly use the practitioner’s title and reiterate it throughout the conversation. For example, “Would you like to see our nurse practitioner, Alice Smith, next week?” or “So, our physician assistant Mrs. Jones will see you Friday at 3 PM.”
The report also found that 76% of patients expressed a preference to see a physician over a PA, and 71% expressed a preference to see a physician over an NP, but offering appointments with nonphysician providers is part of the education process.
“Some families are super savvy and know the differences between nurse practitioners, physician assistants, and doctors, and ... there are families who don’t understand those titles, [and] we need to explain what they do in our practice,” adds Nicole Aaronson, MD, MBA, attending surgeon at Nemours Children’s Health of Delaware. Dr. Aaronson believes there’s an opportunity for educating patients when speaking about all the available providers they may see.
Hanging posters or using brochures in the clinic or hospital is another effective way to reinforce the roles of various providers on the care team. Include biographies and educational information on practice materials and video programs running in the waiting room.
“Patients mean it [calling everyone doctor] as a way to respectfully address the nurse practitioner or physician assistant rather than meaning it as a denigration of the physician,” Dr. Aaronson says. “But everyone appreciates being called by the correct title.”
Helping patients understand the members of their care team and the correct titles to use for those health care professionals could also help patients feel more confident about their health care experience.
“Patients really like knowing that there are specialists in each of the areas taking care of them,” Ms. Flores says. “I think that conveys a feeling of trust in your provider.”
Not everyone is a doctor
Even when PAs and NPs remind patients of their roles and reinforce the use of their preferred names, there will still be patients who continue referring to their nonphysician provider as “doctor.”
“There’s a perception that anyone who walks into a room with a stethoscope is your doctor,” says Graig Straus, DNP, an NP and president and CEO of Rockland Urgent Care Family Health NP, P.C., West Haverstraw, N.Y. “You do get a little bit of burnout correcting people all the time.”
Dr. Straus, who earned his doctorate in nursing practice, notes that patients using the honorific with him aren’t incorrect, but he still educates them on his role within the health care team.
“NPs and PAs have a valuable role to play independently and in concert with the physician,” Dr. Aaronson says. This understanding is essential, as states consider expanding treatment abilities for NPs and PAs.
NPs have expanded treatment abilities or full practice authority in almost half the states, and 31% of the physicians surveyed agreed that NPs should have expanded treatment abilities.
An estimated 1 in 5 states characterizes the physician-PA relationship as collaborative, not supervisory, according to the American Academy of Physician Associates. At the same time, only 39% of physicians surveyed said they favored this trend.
“Patients need great quality care, and there are many different types of providers that can provide that care as part of the team,” Ms. Flores says. “When you have a team taking care of a patient, that patient [gets] the best care possible – and ... that’s why we went into medicine: to deliver high-quality, compassionate care to our patients, and we should all be in this together.”
When practices do their part explaining who is and isn’t a doctor and what each provider’s title and role is and what to call them, and everyone reinforces it, health care becomes not only more manageable for patients to traverse but easier to understand, leading to a better experience.
A version of this article first appeared on Medscape.com.
Physician sues AMA for defamation over 2022 election controversy
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
Will your smartphone be the next doctor’s office?
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
AGA venture capital fund makes first investment
The American Gastroenterological Association has made the first investment through its new venture capital fund – an initiative that gives gastroenterologists a financial opportunity combined with a chance to help corporations trying to make a difference in the field.
The AGA recently announced the fund’s first investment with Carlsbad, Calif.–based Virgo Surgical Video Solutions, which offers endoscopy video recording that uses artificial intelligence for ease of use during procedures, for reviewing video later, and for using video to connect trial investigators with potential candidates.
“While AGA has long guided innovators who share our goal of improving digestive health care, we have doubled down on this commitment by establishing the GI Opportunity Fund,” said Lawrence Kosinski, MD, AGAF, AGA Governing Board Councilor for Development and Growth. “The fund’s first investment – Virgo – exemplifies our pursuit of improved clinical care.”
He said the fund gives physicians a chance to work closely with AGA to invest in difference-making ventures.
“Through our venture fund, gastroenterologists can join AGA to invest in fast-growing, early-stage companies that are transforming care for patients with digestive disease,” Dr. Kosinski said.
Virgo CEO Matthew Z. Schwartz said the company’s product is intended to fill an important need.
“We recognized that it was really difficult for doctors to capture endoscopy procedures video in high-definition at scale,” he said. “Generally, they were just taking still images. And the images were often not of great quality.”
Virgo offers a small device that connects to existing endoscopy equipment, plugging into the back of a video processor, securely compressing and encrypting video and sending it to Virgo’s HIPAA-compliant cloud storage Web portal. Once it’s plugged in, Mr. Schwartz said, it’s “set it and forget it.”
“We try to make it as easy as possible for doctors to record their video – which means we don’t want them to have to do anything different about their normal clinical workflow in order to generate these videos,” Mr. Schwartz said. Physicians don’t even have to press a start or stop button – Virgo’s machine-learning algorithm detects when to start and stop video recording by discerning when the scope is inserted and removed.
“A goal of ours is to change the paradigm for endoscopy to help make sure that every procedure is captured in HD to the cloud,” he said.
The service also includes an “auto-highlight” feature that detects important moments in the procedure video. It automatically marks points in the video when the physician takes a still image and moments when an instrument, such as a snare or forceps, is present in the field of view. This, Mr. Schwartz said, makes it “easy in playback to focus on important aspects of the procedure.”
There is also a clinical trial screening feature, called “auto IBD,” that involves an algorithm that assesses videos to identify patients most likely to be eligible candidates for clinical trials. Mr. Schwartz said that procedures and patients who might go unconsidered – if they are performed at an affiliated community hospital or at an endoscopy center, for instance – can now be brought to the attention of trial investigators, without the need to comb through hundreds or thousands of candidates.
“We believe there are many more patients with these diseases that are eligible for IBD clinical trials than are currently being exposed to research opportunities within large health systems,” he said.
The proceeds from the AGA’s Opportunity Fund will be used, in part, to expand Virgo’s reach, he added. Virgo’s connection with the AGA began with its participation in the AGA Tech Summit Shark Tank competition in 2018.
“For us, the name of the game is getting Virgo in the hands of as many physicians and health systems as possible,” Mr. Schwartz said. “So we’ll be using these proceeds to build up the team and work on global distribution.” The company is also “looking to refine machine-learning algorithms and build out new features and tools.”
Ziad Gellad, MD, MPH, associate professor of medicine in gastroenterology at Duke University, Durham, N.C., was one of the Opportunity Fund’s earliest member investors.
“I was looking for ways to diversify my portfolio and this was an attractive way to get into an area of investment that is not easily accessible, and so I was excited about that,” said Dr. Gellad, who himself is cofounder of a health start-up that develops software for patient navigation and outcomes collection but is not associated with the fund.
“As a start-up cofounder myself, I understand the needs of founders of companies, especially those in the GI space and appreciate the struggles they face,” Dr. Gellad added. “The opportunity to contribute to that was appealing.”
“I also believe that specialty societies like the AGA need to diversify their funding strategy and I think this is a really innovative way to do that,” he said.
The American Gastroenterological Association has made the first investment through its new venture capital fund – an initiative that gives gastroenterologists a financial opportunity combined with a chance to help corporations trying to make a difference in the field.
The AGA recently announced the fund’s first investment with Carlsbad, Calif.–based Virgo Surgical Video Solutions, which offers endoscopy video recording that uses artificial intelligence for ease of use during procedures, for reviewing video later, and for using video to connect trial investigators with potential candidates.
“While AGA has long guided innovators who share our goal of improving digestive health care, we have doubled down on this commitment by establishing the GI Opportunity Fund,” said Lawrence Kosinski, MD, AGAF, AGA Governing Board Councilor for Development and Growth. “The fund’s first investment – Virgo – exemplifies our pursuit of improved clinical care.”
He said the fund gives physicians a chance to work closely with AGA to invest in difference-making ventures.
“Through our venture fund, gastroenterologists can join AGA to invest in fast-growing, early-stage companies that are transforming care for patients with digestive disease,” Dr. Kosinski said.
Virgo CEO Matthew Z. Schwartz said the company’s product is intended to fill an important need.
“We recognized that it was really difficult for doctors to capture endoscopy procedures video in high-definition at scale,” he said. “Generally, they were just taking still images. And the images were often not of great quality.”
Virgo offers a small device that connects to existing endoscopy equipment, plugging into the back of a video processor, securely compressing and encrypting video and sending it to Virgo’s HIPAA-compliant cloud storage Web portal. Once it’s plugged in, Mr. Schwartz said, it’s “set it and forget it.”
“We try to make it as easy as possible for doctors to record their video – which means we don’t want them to have to do anything different about their normal clinical workflow in order to generate these videos,” Mr. Schwartz said. Physicians don’t even have to press a start or stop button – Virgo’s machine-learning algorithm detects when to start and stop video recording by discerning when the scope is inserted and removed.
“A goal of ours is to change the paradigm for endoscopy to help make sure that every procedure is captured in HD to the cloud,” he said.
The service also includes an “auto-highlight” feature that detects important moments in the procedure video. It automatically marks points in the video when the physician takes a still image and moments when an instrument, such as a snare or forceps, is present in the field of view. This, Mr. Schwartz said, makes it “easy in playback to focus on important aspects of the procedure.”
There is also a clinical trial screening feature, called “auto IBD,” that involves an algorithm that assesses videos to identify patients most likely to be eligible candidates for clinical trials. Mr. Schwartz said that procedures and patients who might go unconsidered – if they are performed at an affiliated community hospital or at an endoscopy center, for instance – can now be brought to the attention of trial investigators, without the need to comb through hundreds or thousands of candidates.
“We believe there are many more patients with these diseases that are eligible for IBD clinical trials than are currently being exposed to research opportunities within large health systems,” he said.
The proceeds from the AGA’s Opportunity Fund will be used, in part, to expand Virgo’s reach, he added. Virgo’s connection with the AGA began with its participation in the AGA Tech Summit Shark Tank competition in 2018.
“For us, the name of the game is getting Virgo in the hands of as many physicians and health systems as possible,” Mr. Schwartz said. “So we’ll be using these proceeds to build up the team and work on global distribution.” The company is also “looking to refine machine-learning algorithms and build out new features and tools.”
Ziad Gellad, MD, MPH, associate professor of medicine in gastroenterology at Duke University, Durham, N.C., was one of the Opportunity Fund’s earliest member investors.
“I was looking for ways to diversify my portfolio and this was an attractive way to get into an area of investment that is not easily accessible, and so I was excited about that,” said Dr. Gellad, who himself is cofounder of a health start-up that develops software for patient navigation and outcomes collection but is not associated with the fund.
“As a start-up cofounder myself, I understand the needs of founders of companies, especially those in the GI space and appreciate the struggles they face,” Dr. Gellad added. “The opportunity to contribute to that was appealing.”
“I also believe that specialty societies like the AGA need to diversify their funding strategy and I think this is a really innovative way to do that,” he said.
The American Gastroenterological Association has made the first investment through its new venture capital fund – an initiative that gives gastroenterologists a financial opportunity combined with a chance to help corporations trying to make a difference in the field.
The AGA recently announced the fund’s first investment with Carlsbad, Calif.–based Virgo Surgical Video Solutions, which offers endoscopy video recording that uses artificial intelligence for ease of use during procedures, for reviewing video later, and for using video to connect trial investigators with potential candidates.
“While AGA has long guided innovators who share our goal of improving digestive health care, we have doubled down on this commitment by establishing the GI Opportunity Fund,” said Lawrence Kosinski, MD, AGAF, AGA Governing Board Councilor for Development and Growth. “The fund’s first investment – Virgo – exemplifies our pursuit of improved clinical care.”
He said the fund gives physicians a chance to work closely with AGA to invest in difference-making ventures.
“Through our venture fund, gastroenterologists can join AGA to invest in fast-growing, early-stage companies that are transforming care for patients with digestive disease,” Dr. Kosinski said.
Virgo CEO Matthew Z. Schwartz said the company’s product is intended to fill an important need.
“We recognized that it was really difficult for doctors to capture endoscopy procedures video in high-definition at scale,” he said. “Generally, they were just taking still images. And the images were often not of great quality.”
Virgo offers a small device that connects to existing endoscopy equipment, plugging into the back of a video processor, securely compressing and encrypting video and sending it to Virgo’s HIPAA-compliant cloud storage Web portal. Once it’s plugged in, Mr. Schwartz said, it’s “set it and forget it.”
“We try to make it as easy as possible for doctors to record their video – which means we don’t want them to have to do anything different about their normal clinical workflow in order to generate these videos,” Mr. Schwartz said. Physicians don’t even have to press a start or stop button – Virgo’s machine-learning algorithm detects when to start and stop video recording by discerning when the scope is inserted and removed.
“A goal of ours is to change the paradigm for endoscopy to help make sure that every procedure is captured in HD to the cloud,” he said.
The service also includes an “auto-highlight” feature that detects important moments in the procedure video. It automatically marks points in the video when the physician takes a still image and moments when an instrument, such as a snare or forceps, is present in the field of view. This, Mr. Schwartz said, makes it “easy in playback to focus on important aspects of the procedure.”
There is also a clinical trial screening feature, called “auto IBD,” that involves an algorithm that assesses videos to identify patients most likely to be eligible candidates for clinical trials. Mr. Schwartz said that procedures and patients who might go unconsidered – if they are performed at an affiliated community hospital or at an endoscopy center, for instance – can now be brought to the attention of trial investigators, without the need to comb through hundreds or thousands of candidates.
“We believe there are many more patients with these diseases that are eligible for IBD clinical trials than are currently being exposed to research opportunities within large health systems,” he said.
The proceeds from the AGA’s Opportunity Fund will be used, in part, to expand Virgo’s reach, he added. Virgo’s connection with the AGA began with its participation in the AGA Tech Summit Shark Tank competition in 2018.
“For us, the name of the game is getting Virgo in the hands of as many physicians and health systems as possible,” Mr. Schwartz said. “So we’ll be using these proceeds to build up the team and work on global distribution.” The company is also “looking to refine machine-learning algorithms and build out new features and tools.”
Ziad Gellad, MD, MPH, associate professor of medicine in gastroenterology at Duke University, Durham, N.C., was one of the Opportunity Fund’s earliest member investors.
“I was looking for ways to diversify my portfolio and this was an attractive way to get into an area of investment that is not easily accessible, and so I was excited about that,” said Dr. Gellad, who himself is cofounder of a health start-up that develops software for patient navigation and outcomes collection but is not associated with the fund.
“As a start-up cofounder myself, I understand the needs of founders of companies, especially those in the GI space and appreciate the struggles they face,” Dr. Gellad added. “The opportunity to contribute to that was appealing.”
“I also believe that specialty societies like the AGA need to diversify their funding strategy and I think this is a really innovative way to do that,” he said.
How to talk with patients in ways that help them feel heard and understood
How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?
Here are a few suggestions on how to do this.
Practice intent listening
When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.
When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.
It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
Use terminology that patients understand
Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.
Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.
It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”
Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
Be comfortable saying you don’t know
Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.
Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
Ask your patients what they think is causing their symptoms
This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.
Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?
Here are a few suggestions on how to do this.
Practice intent listening
When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.
When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.
It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
Use terminology that patients understand
Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.
Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.
It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”
Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
Be comfortable saying you don’t know
Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.
Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
Ask your patients what they think is causing their symptoms
This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.
Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?
Here are a few suggestions on how to do this.
Practice intent listening
When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.
When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.
It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
Use terminology that patients understand
Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.
Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.
It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”
Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
Be comfortable saying you don’t know
Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.
Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
Ask your patients what they think is causing their symptoms
This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.
Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
Adverse events reported in one-quarter of inpatient admissions
as indicated from data from 2,809 admissions at 11 hospitals.
The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.
“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.
In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.
Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.
A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.
A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.
The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
Overcoming barriers to better safety
“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.
“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”
“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.
As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.
The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.
However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
Timely reassessment and opportunities to improve
In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.
“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.
“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.
“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.
The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
as indicated from data from 2,809 admissions at 11 hospitals.
The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.
“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.
In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.
Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.
A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.
A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.
The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
Overcoming barriers to better safety
“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.
“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”
“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.
As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.
The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.
However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
Timely reassessment and opportunities to improve
In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.
“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.
“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.
“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.
The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
as indicated from data from 2,809 admissions at 11 hospitals.
The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.
“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.
In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.
Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.
A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.
A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.
The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
Overcoming barriers to better safety
“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.
“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”
“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.
As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.
The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.
However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
Timely reassessment and opportunities to improve
In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.
“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.
“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.
“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.
The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Oncologists may be too quick to refer patients to palliative care
I recently met Jane, a 53-year-old woman with metastatic breast cancer. She was referred to me by the breast oncology team, which routinely refers all metastatic patients to our palliative care clinic.
Clocking in at under 20 minutes, my consultation with Jane might have been one of my shortest on record. Not only had the breast oncology team already addressed Jane’s symptoms, which mainly consisted of hot flashes and joint pain attributable to treatment with an aromatase inhibitor, but they had already started planning ahead for the future of her illness. Jane had completed an advance directive and had a realistic and hopeful perspective on how her illness would progress. She understood the goal of her treatment was to “keep the cancer asleep,” as she put it, and she was very clear about her own goals: to live long enough to see her granddaughter graduate from high school in 2 years and to take a long-awaited trip to Australia later in 2023.
There wasn’t much for me to do. In fact, I daresay that Jane really did not need to see a palliative care specialist because the primary palliative care she was receiving from the breast oncology team was superb. Jane was receiving excellent symptom management from a nurse practitioner and oncologist, plus a social worker provided her with coping strategies. She was already having conversations with her primary medical team and her family about what to expect in the future and how to plan ahead for all possible outcomes.
When should a patient be referred to palliative care?
Integrating palliative care into routine oncologic care need not always require the time and skill of a palliative care team for every patient. Oncology providers can provide basic palliative care services without consulting a palliative care specialist.
For example, if a primary care doctor tried to refer every patient with hypertension to cardiology, the cardiologist would probably say that primary care should be able to handle basic hypertension management. In my experience from working in an oncology clinic for the past 9 years, I’ve found that oncology providers don’t need to refer every advanced cancer patient to our palliative care program. Most oncologists have good communication skills and are more than capable of managing symptoms for patients.
But don’t get me wrong.
Palliative care for all?
In 2010, Jennifer S. Temel MD, published a landmark study in the New England Journal of Medicine that demonstrated significant improvements in quality of life and mood in patients with metastatic lung cancer who received concurrent palliative care. After the study was published many voices inside oncology and palliative care began to advocate for a “palliative care for all” approach to patients with metastatic disease. But this is often interpreted as “specialty palliative care for all,” rather than its original intended meaning that all patients with metastatic disease receive the essential elements of palliative care (biopsychosocial symptom support and conversations about goals of care) either through their primary oncology teams or, if needed, specialty palliative care teams.
The fact is that most specialty palliative care clinics do not have the manpower to meet the needs of all patients with advanced cancers, much less all patients living with serious illness. A main goal of integrating palliative care into routine outpatient health care has always been (and in my opinion, should continue to be) to enhance the primary palliative care skills of specialists, such as oncologists and cardiologists, who care for some of our sickest patients.
This could take many forms. For one, it can be helpful to screen patients for palliative care needs. The American College of Surgeons Commission on Cancer mandates distress screening for all patients as a condition of accreditation. Distress screening using a validated tool such as the National Comprehensive Cancer Network Distress Thermometer can differentiate patients who have minimal distress and may not need much additional support beyond what is provided by their oncology team from those whose distress feels unmanageable and overwhelming.
In terms of primary palliative care symptom management, most oncology teams I work with are comfortable prescribing basic medications for pain, nausea, constipation, and anxiety. They’re also comfortable referring oncology patients for nutrition needs while undergoing chemotherapy as well as to social work and spiritual care for emotional support and counseling.
Oncology teams should continually work on communications skills. They should use “Ask, Tell, Ask” to elicit prognostic awareness, convey critical information, and assess for recall and understanding at pivotal points in the cancer journey, such as when the disease progresses or the patient’s clinical condition changes. They should practice a normalizing script they can use to introduce advance care planning to their patients in the first few visits. When I meet with a patient for the first time, I usually begin by asking if they have prepared an advanced directive. If not, I ask if they’ve thought about who will make medical decisions for them should the need arise. If the patient has documented in writing their preference for care in an emergency situation, I ask for a copy for their chart.
When should patients be referred to a specialty palliative care program?
I tell our oncology teams to involve me after they have tried to intervene, but unsuccessfully because of the patient having intractable symptoms, such as pain, or the disease is not responding to treatments. Or, because there are significant communication or health literacy barriers. Or, because there are challenging family dynamics that are impeding progress in establishing goals of care.
A physician should refer to specialty palliative care when there are multiple comorbid conditions that impact a patient’s prognosis and ability to tolerate treatments. These patients will need detailed symptom management and nuanced conversations about the delicate balance of maintaining quality of life and trying to address their malignancy while also avoiding treatments that may do more harm than good.
At the end of the day, all patients with serious illnesses deserve a palliative care approach to their care from all of their clinicians, not just from the palliative care team. By continuously honing and implementing primary palliative care skills, oncology teams can feel empowered to meet the needs of their patients themselves, strengthening their bond with their patients making truly patient-centered care much more likely.
Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.
I recently met Jane, a 53-year-old woman with metastatic breast cancer. She was referred to me by the breast oncology team, which routinely refers all metastatic patients to our palliative care clinic.
Clocking in at under 20 minutes, my consultation with Jane might have been one of my shortest on record. Not only had the breast oncology team already addressed Jane’s symptoms, which mainly consisted of hot flashes and joint pain attributable to treatment with an aromatase inhibitor, but they had already started planning ahead for the future of her illness. Jane had completed an advance directive and had a realistic and hopeful perspective on how her illness would progress. She understood the goal of her treatment was to “keep the cancer asleep,” as she put it, and she was very clear about her own goals: to live long enough to see her granddaughter graduate from high school in 2 years and to take a long-awaited trip to Australia later in 2023.
There wasn’t much for me to do. In fact, I daresay that Jane really did not need to see a palliative care specialist because the primary palliative care she was receiving from the breast oncology team was superb. Jane was receiving excellent symptom management from a nurse practitioner and oncologist, plus a social worker provided her with coping strategies. She was already having conversations with her primary medical team and her family about what to expect in the future and how to plan ahead for all possible outcomes.
When should a patient be referred to palliative care?
Integrating palliative care into routine oncologic care need not always require the time and skill of a palliative care team for every patient. Oncology providers can provide basic palliative care services without consulting a palliative care specialist.
For example, if a primary care doctor tried to refer every patient with hypertension to cardiology, the cardiologist would probably say that primary care should be able to handle basic hypertension management. In my experience from working in an oncology clinic for the past 9 years, I’ve found that oncology providers don’t need to refer every advanced cancer patient to our palliative care program. Most oncologists have good communication skills and are more than capable of managing symptoms for patients.
But don’t get me wrong.
Palliative care for all?
In 2010, Jennifer S. Temel MD, published a landmark study in the New England Journal of Medicine that demonstrated significant improvements in quality of life and mood in patients with metastatic lung cancer who received concurrent palliative care. After the study was published many voices inside oncology and palliative care began to advocate for a “palliative care for all” approach to patients with metastatic disease. But this is often interpreted as “specialty palliative care for all,” rather than its original intended meaning that all patients with metastatic disease receive the essential elements of palliative care (biopsychosocial symptom support and conversations about goals of care) either through their primary oncology teams or, if needed, specialty palliative care teams.
The fact is that most specialty palliative care clinics do not have the manpower to meet the needs of all patients with advanced cancers, much less all patients living with serious illness. A main goal of integrating palliative care into routine outpatient health care has always been (and in my opinion, should continue to be) to enhance the primary palliative care skills of specialists, such as oncologists and cardiologists, who care for some of our sickest patients.
This could take many forms. For one, it can be helpful to screen patients for palliative care needs. The American College of Surgeons Commission on Cancer mandates distress screening for all patients as a condition of accreditation. Distress screening using a validated tool such as the National Comprehensive Cancer Network Distress Thermometer can differentiate patients who have minimal distress and may not need much additional support beyond what is provided by their oncology team from those whose distress feels unmanageable and overwhelming.
In terms of primary palliative care symptom management, most oncology teams I work with are comfortable prescribing basic medications for pain, nausea, constipation, and anxiety. They’re also comfortable referring oncology patients for nutrition needs while undergoing chemotherapy as well as to social work and spiritual care for emotional support and counseling.
Oncology teams should continually work on communications skills. They should use “Ask, Tell, Ask” to elicit prognostic awareness, convey critical information, and assess for recall and understanding at pivotal points in the cancer journey, such as when the disease progresses or the patient’s clinical condition changes. They should practice a normalizing script they can use to introduce advance care planning to their patients in the first few visits. When I meet with a patient for the first time, I usually begin by asking if they have prepared an advanced directive. If not, I ask if they’ve thought about who will make medical decisions for them should the need arise. If the patient has documented in writing their preference for care in an emergency situation, I ask for a copy for their chart.
When should patients be referred to a specialty palliative care program?
I tell our oncology teams to involve me after they have tried to intervene, but unsuccessfully because of the patient having intractable symptoms, such as pain, or the disease is not responding to treatments. Or, because there are significant communication or health literacy barriers. Or, because there are challenging family dynamics that are impeding progress in establishing goals of care.
A physician should refer to specialty palliative care when there are multiple comorbid conditions that impact a patient’s prognosis and ability to tolerate treatments. These patients will need detailed symptom management and nuanced conversations about the delicate balance of maintaining quality of life and trying to address their malignancy while also avoiding treatments that may do more harm than good.
At the end of the day, all patients with serious illnesses deserve a palliative care approach to their care from all of their clinicians, not just from the palliative care team. By continuously honing and implementing primary palliative care skills, oncology teams can feel empowered to meet the needs of their patients themselves, strengthening their bond with their patients making truly patient-centered care much more likely.
Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.
I recently met Jane, a 53-year-old woman with metastatic breast cancer. She was referred to me by the breast oncology team, which routinely refers all metastatic patients to our palliative care clinic.
Clocking in at under 20 minutes, my consultation with Jane might have been one of my shortest on record. Not only had the breast oncology team already addressed Jane’s symptoms, which mainly consisted of hot flashes and joint pain attributable to treatment with an aromatase inhibitor, but they had already started planning ahead for the future of her illness. Jane had completed an advance directive and had a realistic and hopeful perspective on how her illness would progress. She understood the goal of her treatment was to “keep the cancer asleep,” as she put it, and she was very clear about her own goals: to live long enough to see her granddaughter graduate from high school in 2 years and to take a long-awaited trip to Australia later in 2023.
There wasn’t much for me to do. In fact, I daresay that Jane really did not need to see a palliative care specialist because the primary palliative care she was receiving from the breast oncology team was superb. Jane was receiving excellent symptom management from a nurse practitioner and oncologist, plus a social worker provided her with coping strategies. She was already having conversations with her primary medical team and her family about what to expect in the future and how to plan ahead for all possible outcomes.
When should a patient be referred to palliative care?
Integrating palliative care into routine oncologic care need not always require the time and skill of a palliative care team for every patient. Oncology providers can provide basic palliative care services without consulting a palliative care specialist.
For example, if a primary care doctor tried to refer every patient with hypertension to cardiology, the cardiologist would probably say that primary care should be able to handle basic hypertension management. In my experience from working in an oncology clinic for the past 9 years, I’ve found that oncology providers don’t need to refer every advanced cancer patient to our palliative care program. Most oncologists have good communication skills and are more than capable of managing symptoms for patients.
But don’t get me wrong.
Palliative care for all?
In 2010, Jennifer S. Temel MD, published a landmark study in the New England Journal of Medicine that demonstrated significant improvements in quality of life and mood in patients with metastatic lung cancer who received concurrent palliative care. After the study was published many voices inside oncology and palliative care began to advocate for a “palliative care for all” approach to patients with metastatic disease. But this is often interpreted as “specialty palliative care for all,” rather than its original intended meaning that all patients with metastatic disease receive the essential elements of palliative care (biopsychosocial symptom support and conversations about goals of care) either through their primary oncology teams or, if needed, specialty palliative care teams.
The fact is that most specialty palliative care clinics do not have the manpower to meet the needs of all patients with advanced cancers, much less all patients living with serious illness. A main goal of integrating palliative care into routine outpatient health care has always been (and in my opinion, should continue to be) to enhance the primary palliative care skills of specialists, such as oncologists and cardiologists, who care for some of our sickest patients.
This could take many forms. For one, it can be helpful to screen patients for palliative care needs. The American College of Surgeons Commission on Cancer mandates distress screening for all patients as a condition of accreditation. Distress screening using a validated tool such as the National Comprehensive Cancer Network Distress Thermometer can differentiate patients who have minimal distress and may not need much additional support beyond what is provided by their oncology team from those whose distress feels unmanageable and overwhelming.
In terms of primary palliative care symptom management, most oncology teams I work with are comfortable prescribing basic medications for pain, nausea, constipation, and anxiety. They’re also comfortable referring oncology patients for nutrition needs while undergoing chemotherapy as well as to social work and spiritual care for emotional support and counseling.
Oncology teams should continually work on communications skills. They should use “Ask, Tell, Ask” to elicit prognostic awareness, convey critical information, and assess for recall and understanding at pivotal points in the cancer journey, such as when the disease progresses or the patient’s clinical condition changes. They should practice a normalizing script they can use to introduce advance care planning to their patients in the first few visits. When I meet with a patient for the first time, I usually begin by asking if they have prepared an advanced directive. If not, I ask if they’ve thought about who will make medical decisions for them should the need arise. If the patient has documented in writing their preference for care in an emergency situation, I ask for a copy for their chart.
When should patients be referred to a specialty palliative care program?
I tell our oncology teams to involve me after they have tried to intervene, but unsuccessfully because of the patient having intractable symptoms, such as pain, or the disease is not responding to treatments. Or, because there are significant communication or health literacy barriers. Or, because there are challenging family dynamics that are impeding progress in establishing goals of care.
A physician should refer to specialty palliative care when there are multiple comorbid conditions that impact a patient’s prognosis and ability to tolerate treatments. These patients will need detailed symptom management and nuanced conversations about the delicate balance of maintaining quality of life and trying to address their malignancy while also avoiding treatments that may do more harm than good.
At the end of the day, all patients with serious illnesses deserve a palliative care approach to their care from all of their clinicians, not just from the palliative care team. By continuously honing and implementing primary palliative care skills, oncology teams can feel empowered to meet the needs of their patients themselves, strengthening their bond with their patients making truly patient-centered care much more likely.
Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.