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Dr. Google, potty pot, Snoopy smells cancer
Paging Dr. Google
When something hurts, itches, or burns, to whom do you turn? Not Mom or your physician – we all turn first to Google.
Apparently, sharing symptoms with our omniscient virtual overlords is a national pastime. A recent survey found that nearly 90% of people googled their health symptoms well before going to a doctor. Maybe that’s why we keep getting targeted ads for itchy foot cream?
The survey team constructed a map that broke down the most-googled symptoms for each state. While many states’ highest search were related to cold and flu, some places had more intriguing googles.
Californians have issues with sweaty palms, and New Jerseyans are concerned about their lucid dreaming. Wisconsin seems to have an epidemic of “light-colored poop” (must be all the cheese), while South Carolina has the opposite problem – their most googled symptom is “dark green stool.”
Idaho’s biggest health concern was “symptoms of E. coli”; so, if you’re visiting the Gem State, maybe bring your own food.
Find your state here!
Smartphone skull spikes
Ever felt a little down because you’re just a regular Homo sapiens? Thanks to smartphones, you might be the next step on the evolutionary chain!
Humans have started developing external occipital protuberances – actual spikes – at the base of their skull. Spikes on your skull? How metal is that?
The spike was first observed in 1885. But there has been a rapid increase in the appearance of them, and researchers believe it’s because of smartphones.
Before you start panicking, know that the skull spike is not caused by toxic radiation from your phone. David Shahar’s team from the University of the Sunshine Coast in Australia studied thousands of x-rays. They believe that the skull spikes develop because of the constant hunched-neck position we all take as we pore over our devices for hours a day. The spike is most common in younger people – 1 in 4 people aged 18-30 years had it. This calls for a LOT more yoga.
The nose knows cancer
Just when you thought man’s best friend couldn’t get any better, they go and learn how to smell cancer.
According to a study published in the Journal of the American Osteopathic Association, researchers trained a group of beagles – noted for their superior sense of smell – to sniff out differences in blood samples from healthy patients and those with lung cancer. Snoopy and friends correctly identified the cancerous samples 97% of the time and are now learning how to identify lung, breast, and colorectal cancer using breath samples.
The researchers argued that their findings could pave the way for an over-the-counter test, similar to that used for pregnancy – but where the patient breathes into a device, and it tells them whether they’re positive for cancer or not. However, we suspect the researchers just want to give everyone a dog. There are worse ideas.
And that’s not even the only bit of olfactory-related cancer news we’ve got this week. We’re moving from lung cancer to brain tumors, as a group of researchers at Tampere University in Finland have developed an artificial nose to literally sniff out malignant tissue during surgery.
Electrosurgical resection is common during brain operations, and this process gives off smoke. The nose can detect differences in the smoke from malignant tissue and healthy tissue, allowing the surgeons to more precisely remove tumors from the brain.
No word yet as to whether the surgeons actually have to wear the nose on top of their own, but we can only hope.
Legalizing a not-so-straight flush
How many times has this happened to you? You get up early, hoping to be the first one to the sewage treatment plant so you can get the really fresh wastewater samples. But when you get there, all they have is frozen.
Or maybe you’re part of the research team that analyzed the wastewater of Tacoma, Wash., to determine marijuana usage before and after it became legal in the state. In that case, you’re used to the frozen stuff. Those scientists spent 3 years looking for THC-COOH, which is produced when the psychoactive THC in cannabis is metabolized in the human body, to determine if users were switching from the illegal to the legal market.
Turns out they did. THC-COOH in wastewater increased by 9% per quarter from December 2013 to December 2016, while sales increased by nearly 70% per quarter from Aug. 1, 2014, when legal sales went into effect, to December 2016.
“Given that wastewater represents a total population measure, these findings suggest that many established users switched very quickly from the illegal to the legal market,” team leader Dan Burgard, PhD, of the University of Puget Sound, said in a written statement. “This is the strongest statement possible regarding displacement of the illegal market.”
And the frozen samples? Over the course of the study, the investigators made 387 trips to the two sewage treatment plants. We’ll let MyNorthwest.com explain the rest: “The scientists would pick up a cooler full of frozen wastewater samples, thaw them, and analyze them using liquid chromatography and mass spectrometry.”
Mmm, frozen sewage. Who says science isn’t glamorous?
Paging Dr. Google
When something hurts, itches, or burns, to whom do you turn? Not Mom or your physician – we all turn first to Google.
Apparently, sharing symptoms with our omniscient virtual overlords is a national pastime. A recent survey found that nearly 90% of people googled their health symptoms well before going to a doctor. Maybe that’s why we keep getting targeted ads for itchy foot cream?
The survey team constructed a map that broke down the most-googled symptoms for each state. While many states’ highest search were related to cold and flu, some places had more intriguing googles.
Californians have issues with sweaty palms, and New Jerseyans are concerned about their lucid dreaming. Wisconsin seems to have an epidemic of “light-colored poop” (must be all the cheese), while South Carolina has the opposite problem – their most googled symptom is “dark green stool.”
Idaho’s biggest health concern was “symptoms of E. coli”; so, if you’re visiting the Gem State, maybe bring your own food.
Find your state here!
Smartphone skull spikes
Ever felt a little down because you’re just a regular Homo sapiens? Thanks to smartphones, you might be the next step on the evolutionary chain!
Humans have started developing external occipital protuberances – actual spikes – at the base of their skull. Spikes on your skull? How metal is that?
The spike was first observed in 1885. But there has been a rapid increase in the appearance of them, and researchers believe it’s because of smartphones.
Before you start panicking, know that the skull spike is not caused by toxic radiation from your phone. David Shahar’s team from the University of the Sunshine Coast in Australia studied thousands of x-rays. They believe that the skull spikes develop because of the constant hunched-neck position we all take as we pore over our devices for hours a day. The spike is most common in younger people – 1 in 4 people aged 18-30 years had it. This calls for a LOT more yoga.
The nose knows cancer
Just when you thought man’s best friend couldn’t get any better, they go and learn how to smell cancer.
According to a study published in the Journal of the American Osteopathic Association, researchers trained a group of beagles – noted for their superior sense of smell – to sniff out differences in blood samples from healthy patients and those with lung cancer. Snoopy and friends correctly identified the cancerous samples 97% of the time and are now learning how to identify lung, breast, and colorectal cancer using breath samples.
The researchers argued that their findings could pave the way for an over-the-counter test, similar to that used for pregnancy – but where the patient breathes into a device, and it tells them whether they’re positive for cancer or not. However, we suspect the researchers just want to give everyone a dog. There are worse ideas.
And that’s not even the only bit of olfactory-related cancer news we’ve got this week. We’re moving from lung cancer to brain tumors, as a group of researchers at Tampere University in Finland have developed an artificial nose to literally sniff out malignant tissue during surgery.
Electrosurgical resection is common during brain operations, and this process gives off smoke. The nose can detect differences in the smoke from malignant tissue and healthy tissue, allowing the surgeons to more precisely remove tumors from the brain.
No word yet as to whether the surgeons actually have to wear the nose on top of their own, but we can only hope.
Legalizing a not-so-straight flush
How many times has this happened to you? You get up early, hoping to be the first one to the sewage treatment plant so you can get the really fresh wastewater samples. But when you get there, all they have is frozen.
Or maybe you’re part of the research team that analyzed the wastewater of Tacoma, Wash., to determine marijuana usage before and after it became legal in the state. In that case, you’re used to the frozen stuff. Those scientists spent 3 years looking for THC-COOH, which is produced when the psychoactive THC in cannabis is metabolized in the human body, to determine if users were switching from the illegal to the legal market.
Turns out they did. THC-COOH in wastewater increased by 9% per quarter from December 2013 to December 2016, while sales increased by nearly 70% per quarter from Aug. 1, 2014, when legal sales went into effect, to December 2016.
“Given that wastewater represents a total population measure, these findings suggest that many established users switched very quickly from the illegal to the legal market,” team leader Dan Burgard, PhD, of the University of Puget Sound, said in a written statement. “This is the strongest statement possible regarding displacement of the illegal market.”
And the frozen samples? Over the course of the study, the investigators made 387 trips to the two sewage treatment plants. We’ll let MyNorthwest.com explain the rest: “The scientists would pick up a cooler full of frozen wastewater samples, thaw them, and analyze them using liquid chromatography and mass spectrometry.”
Mmm, frozen sewage. Who says science isn’t glamorous?
Paging Dr. Google
When something hurts, itches, or burns, to whom do you turn? Not Mom or your physician – we all turn first to Google.
Apparently, sharing symptoms with our omniscient virtual overlords is a national pastime. A recent survey found that nearly 90% of people googled their health symptoms well before going to a doctor. Maybe that’s why we keep getting targeted ads for itchy foot cream?
The survey team constructed a map that broke down the most-googled symptoms for each state. While many states’ highest search were related to cold and flu, some places had more intriguing googles.
Californians have issues with sweaty palms, and New Jerseyans are concerned about their lucid dreaming. Wisconsin seems to have an epidemic of “light-colored poop” (must be all the cheese), while South Carolina has the opposite problem – their most googled symptom is “dark green stool.”
Idaho’s biggest health concern was “symptoms of E. coli”; so, if you’re visiting the Gem State, maybe bring your own food.
Find your state here!
Smartphone skull spikes
Ever felt a little down because you’re just a regular Homo sapiens? Thanks to smartphones, you might be the next step on the evolutionary chain!
Humans have started developing external occipital protuberances – actual spikes – at the base of their skull. Spikes on your skull? How metal is that?
The spike was first observed in 1885. But there has been a rapid increase in the appearance of them, and researchers believe it’s because of smartphones.
Before you start panicking, know that the skull spike is not caused by toxic radiation from your phone. David Shahar’s team from the University of the Sunshine Coast in Australia studied thousands of x-rays. They believe that the skull spikes develop because of the constant hunched-neck position we all take as we pore over our devices for hours a day. The spike is most common in younger people – 1 in 4 people aged 18-30 years had it. This calls for a LOT more yoga.
The nose knows cancer
Just when you thought man’s best friend couldn’t get any better, they go and learn how to smell cancer.
According to a study published in the Journal of the American Osteopathic Association, researchers trained a group of beagles – noted for their superior sense of smell – to sniff out differences in blood samples from healthy patients and those with lung cancer. Snoopy and friends correctly identified the cancerous samples 97% of the time and are now learning how to identify lung, breast, and colorectal cancer using breath samples.
The researchers argued that their findings could pave the way for an over-the-counter test, similar to that used for pregnancy – but where the patient breathes into a device, and it tells them whether they’re positive for cancer or not. However, we suspect the researchers just want to give everyone a dog. There are worse ideas.
And that’s not even the only bit of olfactory-related cancer news we’ve got this week. We’re moving from lung cancer to brain tumors, as a group of researchers at Tampere University in Finland have developed an artificial nose to literally sniff out malignant tissue during surgery.
Electrosurgical resection is common during brain operations, and this process gives off smoke. The nose can detect differences in the smoke from malignant tissue and healthy tissue, allowing the surgeons to more precisely remove tumors from the brain.
No word yet as to whether the surgeons actually have to wear the nose on top of their own, but we can only hope.
Legalizing a not-so-straight flush
How many times has this happened to you? You get up early, hoping to be the first one to the sewage treatment plant so you can get the really fresh wastewater samples. But when you get there, all they have is frozen.
Or maybe you’re part of the research team that analyzed the wastewater of Tacoma, Wash., to determine marijuana usage before and after it became legal in the state. In that case, you’re used to the frozen stuff. Those scientists spent 3 years looking for THC-COOH, which is produced when the psychoactive THC in cannabis is metabolized in the human body, to determine if users were switching from the illegal to the legal market.
Turns out they did. THC-COOH in wastewater increased by 9% per quarter from December 2013 to December 2016, while sales increased by nearly 70% per quarter from Aug. 1, 2014, when legal sales went into effect, to December 2016.
“Given that wastewater represents a total population measure, these findings suggest that many established users switched very quickly from the illegal to the legal market,” team leader Dan Burgard, PhD, of the University of Puget Sound, said in a written statement. “This is the strongest statement possible regarding displacement of the illegal market.”
And the frozen samples? Over the course of the study, the investigators made 387 trips to the two sewage treatment plants. We’ll let MyNorthwest.com explain the rest: “The scientists would pick up a cooler full of frozen wastewater samples, thaw them, and analyze them using liquid chromatography and mass spectrometry.”
Mmm, frozen sewage. Who says science isn’t glamorous?
Rituximab and vemurafenib could challenge frontline chemotherapy for HCL
AMSTERDAM – A combination of rituximab and the BRAF inhibitor vemurafenib could be the one-two punch needed for relapsed or refractory hairy cell leukemia (HCL), according to investigators.
Among evaluable patients treated with this combination, 96% achieved complete remission, reported lead author, Enrico Tiacci, MD, of the University and Hospital of Perugia, Italy.
This level of efficacy is “clearly superior to historical results with either agent alone,” Dr. Tiacci said during a presentation at the annual congress of the European Hematology Association, citing previous complete response rates with vemurafenib alone of 35%-40%. “[This combination] has potential for challenging chemotherapy in the frontline setting,” he said.
The phase 2 trial involved 31 patients with relapsed or refractory HCL who had received a median of three previous therapies. Eight of the patients (26%) had primary refractory disease. Patients received vemurafenib 960 mg, twice daily for 8 weeks and rituximab 375 mg/m2, every 2 weeks. After finishing vemurafenib, patients received rituximab four more times, keeping the interval of 2 weeks. Complete remission was defined as a normal blood count, no leukemic cells in bone marrow biopsies and blood smears, and no palpable splenomegaly.
Out of 31 patients, 27 were evaluable at data cutoff. Of these, 26 (96%) achieved complete remission. The investigators noted that two complete responders had incomplete platelet recovery at the end of treatment that resolved soon after, and two patients had persistent splenomegaly, but were considered to be in complete remission at 22.5 and 25 months after finishing therapy.
All of the complete responders had previously received purine analogs, while a few had been refractory to a prior BRAF inhibitor (n = 7) and/or rituximab (n = 5).
The investigators also pointed out that 15 out of 24 evaluable patients (63%) achieved complete remission just 4 weeks after starting the trial regimen. Almost two-thirds of patients (65%) were negative for minimal residual disease (MRD). The rate of progression-free survival at a median follow-up of 29.5 months was 83%. Disease progression occurred exclusively in patients who were MRD positive.
The combination was well tolerated; most adverse events were of grade 1 or 2, overlapping with the safety profile of each agent alone.
Reflecting on the study findings, Dr. Tiacci suggested that the combination could be most effective if delivered immediately, instead of after BRAF failure.
“Interestingly,” he said, “the relapse-free survival in patients naive to a BRAF inhibitor remained significantly longer than the relapse-free interval that patients previously exposed to a BRAF inhibitor enjoyed, both following monotherapy with a BRAF inhibitor and following subsequent combination with rituximab, potentially suggesting that vemurafenib should be used directly in combination with rituximab rather than being delivered first as a monotherapy and then added to rituximab at relapse.”
Randomized testing of the combination against the chemotherapy-based standard of care in the frontline setting is warranted, the investigators concluded.
Dr. Tiacci reported financial relationships with Roche, AbbVie, and Shire.
SOURCE: Tiacci E et al. EHA Congress, Abstract S104.
AMSTERDAM – A combination of rituximab and the BRAF inhibitor vemurafenib could be the one-two punch needed for relapsed or refractory hairy cell leukemia (HCL), according to investigators.
Among evaluable patients treated with this combination, 96% achieved complete remission, reported lead author, Enrico Tiacci, MD, of the University and Hospital of Perugia, Italy.
This level of efficacy is “clearly superior to historical results with either agent alone,” Dr. Tiacci said during a presentation at the annual congress of the European Hematology Association, citing previous complete response rates with vemurafenib alone of 35%-40%. “[This combination] has potential for challenging chemotherapy in the frontline setting,” he said.
The phase 2 trial involved 31 patients with relapsed or refractory HCL who had received a median of three previous therapies. Eight of the patients (26%) had primary refractory disease. Patients received vemurafenib 960 mg, twice daily for 8 weeks and rituximab 375 mg/m2, every 2 weeks. After finishing vemurafenib, patients received rituximab four more times, keeping the interval of 2 weeks. Complete remission was defined as a normal blood count, no leukemic cells in bone marrow biopsies and blood smears, and no palpable splenomegaly.
Out of 31 patients, 27 were evaluable at data cutoff. Of these, 26 (96%) achieved complete remission. The investigators noted that two complete responders had incomplete platelet recovery at the end of treatment that resolved soon after, and two patients had persistent splenomegaly, but were considered to be in complete remission at 22.5 and 25 months after finishing therapy.
All of the complete responders had previously received purine analogs, while a few had been refractory to a prior BRAF inhibitor (n = 7) and/or rituximab (n = 5).
The investigators also pointed out that 15 out of 24 evaluable patients (63%) achieved complete remission just 4 weeks after starting the trial regimen. Almost two-thirds of patients (65%) were negative for minimal residual disease (MRD). The rate of progression-free survival at a median follow-up of 29.5 months was 83%. Disease progression occurred exclusively in patients who were MRD positive.
The combination was well tolerated; most adverse events were of grade 1 or 2, overlapping with the safety profile of each agent alone.
Reflecting on the study findings, Dr. Tiacci suggested that the combination could be most effective if delivered immediately, instead of after BRAF failure.
“Interestingly,” he said, “the relapse-free survival in patients naive to a BRAF inhibitor remained significantly longer than the relapse-free interval that patients previously exposed to a BRAF inhibitor enjoyed, both following monotherapy with a BRAF inhibitor and following subsequent combination with rituximab, potentially suggesting that vemurafenib should be used directly in combination with rituximab rather than being delivered first as a monotherapy and then added to rituximab at relapse.”
Randomized testing of the combination against the chemotherapy-based standard of care in the frontline setting is warranted, the investigators concluded.
Dr. Tiacci reported financial relationships with Roche, AbbVie, and Shire.
SOURCE: Tiacci E et al. EHA Congress, Abstract S104.
AMSTERDAM – A combination of rituximab and the BRAF inhibitor vemurafenib could be the one-two punch needed for relapsed or refractory hairy cell leukemia (HCL), according to investigators.
Among evaluable patients treated with this combination, 96% achieved complete remission, reported lead author, Enrico Tiacci, MD, of the University and Hospital of Perugia, Italy.
This level of efficacy is “clearly superior to historical results with either agent alone,” Dr. Tiacci said during a presentation at the annual congress of the European Hematology Association, citing previous complete response rates with vemurafenib alone of 35%-40%. “[This combination] has potential for challenging chemotherapy in the frontline setting,” he said.
The phase 2 trial involved 31 patients with relapsed or refractory HCL who had received a median of three previous therapies. Eight of the patients (26%) had primary refractory disease. Patients received vemurafenib 960 mg, twice daily for 8 weeks and rituximab 375 mg/m2, every 2 weeks. After finishing vemurafenib, patients received rituximab four more times, keeping the interval of 2 weeks. Complete remission was defined as a normal blood count, no leukemic cells in bone marrow biopsies and blood smears, and no palpable splenomegaly.
Out of 31 patients, 27 were evaluable at data cutoff. Of these, 26 (96%) achieved complete remission. The investigators noted that two complete responders had incomplete platelet recovery at the end of treatment that resolved soon after, and two patients had persistent splenomegaly, but were considered to be in complete remission at 22.5 and 25 months after finishing therapy.
All of the complete responders had previously received purine analogs, while a few had been refractory to a prior BRAF inhibitor (n = 7) and/or rituximab (n = 5).
The investigators also pointed out that 15 out of 24 evaluable patients (63%) achieved complete remission just 4 weeks after starting the trial regimen. Almost two-thirds of patients (65%) were negative for minimal residual disease (MRD). The rate of progression-free survival at a median follow-up of 29.5 months was 83%. Disease progression occurred exclusively in patients who were MRD positive.
The combination was well tolerated; most adverse events were of grade 1 or 2, overlapping with the safety profile of each agent alone.
Reflecting on the study findings, Dr. Tiacci suggested that the combination could be most effective if delivered immediately, instead of after BRAF failure.
“Interestingly,” he said, “the relapse-free survival in patients naive to a BRAF inhibitor remained significantly longer than the relapse-free interval that patients previously exposed to a BRAF inhibitor enjoyed, both following monotherapy with a BRAF inhibitor and following subsequent combination with rituximab, potentially suggesting that vemurafenib should be used directly in combination with rituximab rather than being delivered first as a monotherapy and then added to rituximab at relapse.”
Randomized testing of the combination against the chemotherapy-based standard of care in the frontline setting is warranted, the investigators concluded.
Dr. Tiacci reported financial relationships with Roche, AbbVie, and Shire.
SOURCE: Tiacci E et al. EHA Congress, Abstract S104.
REPORTING FROM EHA CONGRESS
Subset of patients benefits from in-hospital sleep apnea screening
SAN ANTONIO – In the clinical opinion of Richard J. Schwab, MD,
“Many diseases are adversely affected by sleep apnea, including myocardial infarction, hypertension, a cerebrovascular accident, pulmonary hypertension, atrial fibrillation, diabetes, and congestive heart failure,” Dr. Schwab, interim chief of the University of Pennsylvania Perelman School of Medicine’s Division of Sleep Medicine, said at the annual meeting of the Associated Professional Sleep Societies.
“Continuous positive airway pressure [CPAP] may help heart failure patients and reduce 30-day readmission rates, which has important financial implications in the University of Pennsylvania Health system. CPAP may also decrease the rapid responses and cardiac arrests at night,” he said.
A few years ago, Dr. Schwab and his associates set out to determine whether PAP adherence in cardiac patients with sleep-disordered breathing reduced readmission rates 30 days after discharge (J Clin Sleep Med. 2014;10:1051-59). They evaluated 104 consecutive cardiovascular hospitalized patients reporting symptoms of sleep-disordered breathing (SDB) between January of 2012 and March of 2013, and collected demographic data, SDB type, PAP adherence, and data regarding 30-day hospital readmission/ED visits. Apnea was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor. Hypopnea was scored when there was at least a 50% reduction in airflow with an associated 3% or greater oxyhemoglobin desaturation. Central apnea (CSA) was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor and no effort in the thorax and abdomen. If more than 50% of the apneas were central, the SDB was classified as CSA. If more than 50% of apneas were obstructive in nature, it was considered obstructive sleep apnea (OSA).
The mean age of the patients was 59 years, 63% were male, their mean body mass index was 34 kg/m2, 87% had heart failure, and 82% had hypertension. Of the 104 patients, 81 had SDB and 23 did not. The 30-day readmission rate was 29% in patients who did not use PAP, 30% in partial users, and 0% in full users (P = .0246).
The researchers found that 81 patients (78%) had sleep disordered breathing. Of these, 65 (80%) had OSA while 16 (20%) had CSA. The study demonstrated that performing inpatient sleep studies was feasible. “Our study indicated that SDB is common in hospitalized cardiac patients, with the majority of patients manifesting OSA,” said Dr. Schwab, medical director of the Penn Sleep Centers. “The data suggest that hospital readmission and ED visits 30 days after discharge were significantly lower in patients with cardiac disease and SDB who adhere to PAP treatment than those who are not adherent.”
Dr. Schwab is part of a research team conducting a longer study with ResMed to examine 30-, 60-, and 90-day readmission rates in cardiac inpatients newly diagnosed with OSA and started on auto-PAP (APAP). They plan to evaluate the ejection fraction during hospitalization and in follow-up, as well as the effect of an in-laboratory sleep study at 1 month. The long-term follow-up is planned for 3 years.
Launching an inpatient sleep apnea consult service in the hospital makes sense, Dr. Schwab continued, because home sleep studies are approved for the diagnosis of sleep apnea, APAP can determine optimal CPAP settings, insurance will cover CPAP with a home or inpatient sleep study, and patients can get CPAP/APAP at or before discharge. “Sleep techs or respiratory therapists can perform these sleep studies,” he said. At Penn, a nurse practitioner (NP) runs this service using the Alice NightOne home sleep testing device and the WatchPAT portable sleep apnea diagnostic device.
The notion of performing in-hospital sleep studies should be an easy sell to cardiologists and hospital administrators, Dr. Schwab said, because the program will decrease hospital readmissions, “which is going to save the hospital a lot of money. In addition, these patients can come back for in-laboratory sleep studies. There is also increased revenue from the consults and progress notes, and the professional fee for sleep study interpretation. The most challenging part of the inpatient sleep consult service is trying to get these patients to follow up in the sleep center with the NP.”
Dr. Schwab is an investigator for the recently launched Penn Medicine Nudge Unit Project, which is funded by the National Institutes of Health. The project includes a multidisciplinary team of providers from the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, and Penn Medicine Risk Management. If an inpatient has a BMI of 35 kg/m2 or greater, the clinician will be “nudged” via an enterprise messaging system (EMS) prompt to order an inpatient sleep oximetry. “They have to respond to that nudge,” Dr. Schwab said. “If the oximetry is consistent for sleep apnea, there will be another nudge to consult with the sleep medicine team. If the oximetry is negative, they will be nudged to get an outpatient consult with the sleep medicine team.” For patients undergoing preadmission testing for any type of surgery who score 4 or more on the STOP-Bang questionnaire (Chest 2016;149:631-38), the clinician is “nudged” to order an outpatient sleep consultation.
Benefits to such an approach, he said, include a decrease in resource allocation, shorter hospital stays, patient perceived improvement in quality of sleep, improved patient survey scores, and the fact that apnea treatment may decrease the need for rapid response. “It also reduces medical-legal concerns, improves patient outcomes, decreases readmissions, and generates revenue from inpatient and outpatient sleep studies,” Dr. Schwab said. Barriers to such an approach include the fact that there is no defined pathway at many institutions for recognizing and referring suspected OSA patients. “There is often a lack of care coordination between primary providers and sleep medicine, and sleep is viewed as ambulatory care, not as a part of inpatient care,” he said.
Last year, Dr. Schwab and his colleagues at UPenn conducted a pilot study to develop and test a pathway for identifying OSA in high-risk inpatient and preadmission patient populations. Of 389 patients admitted between Aug. 20 and Sept. 20 of 2018, 43 had a BMI of 35 kg/m2 or greater. Of these, 10 were screened with oximetry and 8 were positive for severe apnea. Of these eight cases, five inpatient consults were ordered, one outpatient consult was ordered, one patient had no consult ordered, and one patient was discharged before the consult was ordered.
Dr. Schwab also performed a pilot study in patients undergoing preoperative testing with the STOP-Bang questionnaire. “When we piloted this, there were over 200 patients who could have been sent to the outpatient sleep consult service, and we referred none,” Dr. Schwab said. “We are just starting to implement a program to screen them. We can treat these people for their sleep apnea and prevent chronic adverse sequelae associated with this disease.”
Both the inpatient and outpatient screening programs for sleep apnea are built within their electronic medical record. “Building this within your EMR requires effort, but it’s doable,” he said.
Dr. Schwab disclosed that he has received grants from the National Institutes of Health, ResMed, and Inspire Medical Systems.
SAN ANTONIO – In the clinical opinion of Richard J. Schwab, MD,
“Many diseases are adversely affected by sleep apnea, including myocardial infarction, hypertension, a cerebrovascular accident, pulmonary hypertension, atrial fibrillation, diabetes, and congestive heart failure,” Dr. Schwab, interim chief of the University of Pennsylvania Perelman School of Medicine’s Division of Sleep Medicine, said at the annual meeting of the Associated Professional Sleep Societies.
“Continuous positive airway pressure [CPAP] may help heart failure patients and reduce 30-day readmission rates, which has important financial implications in the University of Pennsylvania Health system. CPAP may also decrease the rapid responses and cardiac arrests at night,” he said.
A few years ago, Dr. Schwab and his associates set out to determine whether PAP adherence in cardiac patients with sleep-disordered breathing reduced readmission rates 30 days after discharge (J Clin Sleep Med. 2014;10:1051-59). They evaluated 104 consecutive cardiovascular hospitalized patients reporting symptoms of sleep-disordered breathing (SDB) between January of 2012 and March of 2013, and collected demographic data, SDB type, PAP adherence, and data regarding 30-day hospital readmission/ED visits. Apnea was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor. Hypopnea was scored when there was at least a 50% reduction in airflow with an associated 3% or greater oxyhemoglobin desaturation. Central apnea (CSA) was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor and no effort in the thorax and abdomen. If more than 50% of the apneas were central, the SDB was classified as CSA. If more than 50% of apneas were obstructive in nature, it was considered obstructive sleep apnea (OSA).
The mean age of the patients was 59 years, 63% were male, their mean body mass index was 34 kg/m2, 87% had heart failure, and 82% had hypertension. Of the 104 patients, 81 had SDB and 23 did not. The 30-day readmission rate was 29% in patients who did not use PAP, 30% in partial users, and 0% in full users (P = .0246).
The researchers found that 81 patients (78%) had sleep disordered breathing. Of these, 65 (80%) had OSA while 16 (20%) had CSA. The study demonstrated that performing inpatient sleep studies was feasible. “Our study indicated that SDB is common in hospitalized cardiac patients, with the majority of patients manifesting OSA,” said Dr. Schwab, medical director of the Penn Sleep Centers. “The data suggest that hospital readmission and ED visits 30 days after discharge were significantly lower in patients with cardiac disease and SDB who adhere to PAP treatment than those who are not adherent.”
Dr. Schwab is part of a research team conducting a longer study with ResMed to examine 30-, 60-, and 90-day readmission rates in cardiac inpatients newly diagnosed with OSA and started on auto-PAP (APAP). They plan to evaluate the ejection fraction during hospitalization and in follow-up, as well as the effect of an in-laboratory sleep study at 1 month. The long-term follow-up is planned for 3 years.
Launching an inpatient sleep apnea consult service in the hospital makes sense, Dr. Schwab continued, because home sleep studies are approved for the diagnosis of sleep apnea, APAP can determine optimal CPAP settings, insurance will cover CPAP with a home or inpatient sleep study, and patients can get CPAP/APAP at or before discharge. “Sleep techs or respiratory therapists can perform these sleep studies,” he said. At Penn, a nurse practitioner (NP) runs this service using the Alice NightOne home sleep testing device and the WatchPAT portable sleep apnea diagnostic device.
The notion of performing in-hospital sleep studies should be an easy sell to cardiologists and hospital administrators, Dr. Schwab said, because the program will decrease hospital readmissions, “which is going to save the hospital a lot of money. In addition, these patients can come back for in-laboratory sleep studies. There is also increased revenue from the consults and progress notes, and the professional fee for sleep study interpretation. The most challenging part of the inpatient sleep consult service is trying to get these patients to follow up in the sleep center with the NP.”
Dr. Schwab is an investigator for the recently launched Penn Medicine Nudge Unit Project, which is funded by the National Institutes of Health. The project includes a multidisciplinary team of providers from the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, and Penn Medicine Risk Management. If an inpatient has a BMI of 35 kg/m2 or greater, the clinician will be “nudged” via an enterprise messaging system (EMS) prompt to order an inpatient sleep oximetry. “They have to respond to that nudge,” Dr. Schwab said. “If the oximetry is consistent for sleep apnea, there will be another nudge to consult with the sleep medicine team. If the oximetry is negative, they will be nudged to get an outpatient consult with the sleep medicine team.” For patients undergoing preadmission testing for any type of surgery who score 4 or more on the STOP-Bang questionnaire (Chest 2016;149:631-38), the clinician is “nudged” to order an outpatient sleep consultation.
Benefits to such an approach, he said, include a decrease in resource allocation, shorter hospital stays, patient perceived improvement in quality of sleep, improved patient survey scores, and the fact that apnea treatment may decrease the need for rapid response. “It also reduces medical-legal concerns, improves patient outcomes, decreases readmissions, and generates revenue from inpatient and outpatient sleep studies,” Dr. Schwab said. Barriers to such an approach include the fact that there is no defined pathway at many institutions for recognizing and referring suspected OSA patients. “There is often a lack of care coordination between primary providers and sleep medicine, and sleep is viewed as ambulatory care, not as a part of inpatient care,” he said.
Last year, Dr. Schwab and his colleagues at UPenn conducted a pilot study to develop and test a pathway for identifying OSA in high-risk inpatient and preadmission patient populations. Of 389 patients admitted between Aug. 20 and Sept. 20 of 2018, 43 had a BMI of 35 kg/m2 or greater. Of these, 10 were screened with oximetry and 8 were positive for severe apnea. Of these eight cases, five inpatient consults were ordered, one outpatient consult was ordered, one patient had no consult ordered, and one patient was discharged before the consult was ordered.
Dr. Schwab also performed a pilot study in patients undergoing preoperative testing with the STOP-Bang questionnaire. “When we piloted this, there were over 200 patients who could have been sent to the outpatient sleep consult service, and we referred none,” Dr. Schwab said. “We are just starting to implement a program to screen them. We can treat these people for their sleep apnea and prevent chronic adverse sequelae associated with this disease.”
Both the inpatient and outpatient screening programs for sleep apnea are built within their electronic medical record. “Building this within your EMR requires effort, but it’s doable,” he said.
Dr. Schwab disclosed that he has received grants from the National Institutes of Health, ResMed, and Inspire Medical Systems.
SAN ANTONIO – In the clinical opinion of Richard J. Schwab, MD,
“Many diseases are adversely affected by sleep apnea, including myocardial infarction, hypertension, a cerebrovascular accident, pulmonary hypertension, atrial fibrillation, diabetes, and congestive heart failure,” Dr. Schwab, interim chief of the University of Pennsylvania Perelman School of Medicine’s Division of Sleep Medicine, said at the annual meeting of the Associated Professional Sleep Societies.
“Continuous positive airway pressure [CPAP] may help heart failure patients and reduce 30-day readmission rates, which has important financial implications in the University of Pennsylvania Health system. CPAP may also decrease the rapid responses and cardiac arrests at night,” he said.
A few years ago, Dr. Schwab and his associates set out to determine whether PAP adherence in cardiac patients with sleep-disordered breathing reduced readmission rates 30 days after discharge (J Clin Sleep Med. 2014;10:1051-59). They evaluated 104 consecutive cardiovascular hospitalized patients reporting symptoms of sleep-disordered breathing (SDB) between January of 2012 and March of 2013, and collected demographic data, SDB type, PAP adherence, and data regarding 30-day hospital readmission/ED visits. Apnea was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor. Hypopnea was scored when there was at least a 50% reduction in airflow with an associated 3% or greater oxyhemoglobin desaturation. Central apnea (CSA) was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor and no effort in the thorax and abdomen. If more than 50% of the apneas were central, the SDB was classified as CSA. If more than 50% of apneas were obstructive in nature, it was considered obstructive sleep apnea (OSA).
The mean age of the patients was 59 years, 63% were male, their mean body mass index was 34 kg/m2, 87% had heart failure, and 82% had hypertension. Of the 104 patients, 81 had SDB and 23 did not. The 30-day readmission rate was 29% in patients who did not use PAP, 30% in partial users, and 0% in full users (P = .0246).
The researchers found that 81 patients (78%) had sleep disordered breathing. Of these, 65 (80%) had OSA while 16 (20%) had CSA. The study demonstrated that performing inpatient sleep studies was feasible. “Our study indicated that SDB is common in hospitalized cardiac patients, with the majority of patients manifesting OSA,” said Dr. Schwab, medical director of the Penn Sleep Centers. “The data suggest that hospital readmission and ED visits 30 days after discharge were significantly lower in patients with cardiac disease and SDB who adhere to PAP treatment than those who are not adherent.”
Dr. Schwab is part of a research team conducting a longer study with ResMed to examine 30-, 60-, and 90-day readmission rates in cardiac inpatients newly diagnosed with OSA and started on auto-PAP (APAP). They plan to evaluate the ejection fraction during hospitalization and in follow-up, as well as the effect of an in-laboratory sleep study at 1 month. The long-term follow-up is planned for 3 years.
Launching an inpatient sleep apnea consult service in the hospital makes sense, Dr. Schwab continued, because home sleep studies are approved for the diagnosis of sleep apnea, APAP can determine optimal CPAP settings, insurance will cover CPAP with a home or inpatient sleep study, and patients can get CPAP/APAP at or before discharge. “Sleep techs or respiratory therapists can perform these sleep studies,” he said. At Penn, a nurse practitioner (NP) runs this service using the Alice NightOne home sleep testing device and the WatchPAT portable sleep apnea diagnostic device.
The notion of performing in-hospital sleep studies should be an easy sell to cardiologists and hospital administrators, Dr. Schwab said, because the program will decrease hospital readmissions, “which is going to save the hospital a lot of money. In addition, these patients can come back for in-laboratory sleep studies. There is also increased revenue from the consults and progress notes, and the professional fee for sleep study interpretation. The most challenging part of the inpatient sleep consult service is trying to get these patients to follow up in the sleep center with the NP.”
Dr. Schwab is an investigator for the recently launched Penn Medicine Nudge Unit Project, which is funded by the National Institutes of Health. The project includes a multidisciplinary team of providers from the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, and Penn Medicine Risk Management. If an inpatient has a BMI of 35 kg/m2 or greater, the clinician will be “nudged” via an enterprise messaging system (EMS) prompt to order an inpatient sleep oximetry. “They have to respond to that nudge,” Dr. Schwab said. “If the oximetry is consistent for sleep apnea, there will be another nudge to consult with the sleep medicine team. If the oximetry is negative, they will be nudged to get an outpatient consult with the sleep medicine team.” For patients undergoing preadmission testing for any type of surgery who score 4 or more on the STOP-Bang questionnaire (Chest 2016;149:631-38), the clinician is “nudged” to order an outpatient sleep consultation.
Benefits to such an approach, he said, include a decrease in resource allocation, shorter hospital stays, patient perceived improvement in quality of sleep, improved patient survey scores, and the fact that apnea treatment may decrease the need for rapid response. “It also reduces medical-legal concerns, improves patient outcomes, decreases readmissions, and generates revenue from inpatient and outpatient sleep studies,” Dr. Schwab said. Barriers to such an approach include the fact that there is no defined pathway at many institutions for recognizing and referring suspected OSA patients. “There is often a lack of care coordination between primary providers and sleep medicine, and sleep is viewed as ambulatory care, not as a part of inpatient care,” he said.
Last year, Dr. Schwab and his colleagues at UPenn conducted a pilot study to develop and test a pathway for identifying OSA in high-risk inpatient and preadmission patient populations. Of 389 patients admitted between Aug. 20 and Sept. 20 of 2018, 43 had a BMI of 35 kg/m2 or greater. Of these, 10 were screened with oximetry and 8 were positive for severe apnea. Of these eight cases, five inpatient consults were ordered, one outpatient consult was ordered, one patient had no consult ordered, and one patient was discharged before the consult was ordered.
Dr. Schwab also performed a pilot study in patients undergoing preoperative testing with the STOP-Bang questionnaire. “When we piloted this, there were over 200 patients who could have been sent to the outpatient sleep consult service, and we referred none,” Dr. Schwab said. “We are just starting to implement a program to screen them. We can treat these people for their sleep apnea and prevent chronic adverse sequelae associated with this disease.”
Both the inpatient and outpatient screening programs for sleep apnea are built within their electronic medical record. “Building this within your EMR requires effort, but it’s doable,” he said.
Dr. Schwab disclosed that he has received grants from the National Institutes of Health, ResMed, and Inspire Medical Systems.
EXPERT ANALYSIS FROM SLEEP 2019
Affiliate cancer centers: What’s in a name?
Daniel Boffa, MD, was never able to shake the unfortunate incident from his mind. An acquaintance receiving cancer care at an affiliate center of a top-ranked cancer hospital had experienced a poor, and possibly preventable, outcome.
“As I learned more about the outcome, it became clear to me that the affiliate wasn’t prepared to handle a complication that was not unexpected,” said Dr. Boffa, a thoracic surgeon at Yale Cancer Center in New Haven, Conn. “When I talked to this individual and the people who helped make the decision for where care was going to be given, they kept saying over and over, ‘It says the name of a top-ranked hospital on the sign [of the affiliate], therefore it’s the same.’ ”
The incident compelled Dr. Boffa and colleagues to learn more about the safety at affiliate cancer centers. The result is an analysis that found that patients who underwent complex cancer surgery at affiliate hospitals were significantly more likely to die within 90 days, compared with patients receiving the same surgery at the flagship hospital. When the relative safety of each top-ranked cancer hospital was compared with its collective affiliates, the top-ranked hospital was safer than affiliates in 41 of 49 networks studied (JAMA Netw Open. 2019 Apr 12. doi: 10.1001/jamanetworkopen.2019.1912).
The analysis illustrates that a patient’s chances of surviving a complex cancer surgery are markedly lower at affiliates, compared with the hospital whose brand it shares, Dr. Boffa explained.
“Every patient and everybody that is supporting a patient in making these [care] decisions can’t assume the care is the same,” he said. “This is not to say that the affiliates are unsafe, they are just less safe than the top-ranked hospitals.”
The findings come as more top-ranked cancer hospital align with affiliate cancer centers and grow partnerships with smaller, community hospitals.
Leaders at these institutions say the partnerships expand access to care and enable regional centers to draw from the expertise at specialized cancer hospitals. However, in addition to safety concerns, the recent data pose questions about whether marketing by some institutions is creating inaccurate perceptions about the relationship between top hospitals and their affiliates. At the same time, it’s uncertain whether network affiliations really improve cost or quality, said Lesly Dossett, MD, an oncologist and researcher at the University of Michigan, Ann Arbor.
“Affiliation has the theoretical advantage of improving efficiency and quality across hospitals and facilitating regionalization of the most complex patients,” said Dr. Dossett, who wrote a commentary for JAMA on the subject. “An ideal network would provide the patient the most convenient access to the right specialist and service at the right time. Disadvantages are that patients and families can attribute quality and safety outcomes achieved at the flagship hospital to the smaller branded affiliate and decline to travel to the flagship, even though some services, like complex surgery, may be best delivered at the flagship.”
What’s an affiliate?
Part of the problem is the ambiguity surrounding the many different relationships among top-ranked cancer hospitals and associated institutions, said J. Leonard Lichtenfeld, MD, interim chief medical officer for the American Cancer Society. In some cases, the primary institution is closely aligned with an affiliate, sharing staff and collaborating on patient cases. In other instances, a reputable hospital offers its brand to a hospital in a distant location, and the relationship is more marketing and information-sharing based.
“Just because a name shows up on a building, doesn’t necessarily mean the same level of care is being provided at an affiliated institution,” Dr. Lichtenfeld said. “There are factors that neither you nor me can look into to determine how close the affiliation is. Sometimes, it can be a very tight relationship. Sometimes it can be a loose relationship, and it’s very hard to figure that out.”
In a survey of 1,010 patients, 94% of respondents felt that cancer care at a smaller hospital would improve after affiliating with a larger hospital specializing in cancer, and most patients expected physicians at the larger hospital to be involved considerably in the care of patients at the smaller hospital after affiliation (JAMA Oncol. 2018;4[7]:1008-9).
In another survey, 85% of patients said they would rather travel an hour for complex surgery at a larger hospital specializing in cancer, rather than a smaller local hospital. However, if the smaller hospital was affiliated with a top-ranked cancer hospital, 31% of respondents changed their preference to the smaller hospital, according to the analysis (Ann Surg Oncol. 2019 Mar;26[3]:732-8).
When asked to compare leading cancer hospitals and their smaller affiliates, 47% of respondents said they felt that surgical safety would be the same at both hospitals, 66% said that guideline compliance would be the same, and 53% of patients said they believed that cure rates would be the same at both institutions.
“A majority of the public feels when the brand is shared between a top-ranked hospital and a hospital in the community, the quality and safety is the same,” said Dr. Boffa, a coauthor of both survey studies. “The advertising differs for each affiliate, but there are certainly instances where the messaging can be misinterpreted. There are instances where there are billboards and advertisements where the implication is the community hospital to some degree has care that is similar to the main hospital.”
Hospitals: Collaborations beneficial
For the University of Wisconsin–Madison (UW) Carbone Cancer Center, its relationships with several community institutions have enhanced consistency among physician teams and provided new care opportunities for patients, said Dan Mulkerin, MD, regional director of UW’s regional cancer center network. Carbone includes 12 locales of service and four affiliates in various stages of maturity.
In some cases, UW physicians travel to the affiliate to help care for patients but refer surgeries back to the main institution. In other cases, UW surgical specialists operate jointly with local surgeons at the community hospital, according to Dr. Mulkerin.
The surgical safety of affiliates is an issue that UW started to address about 5 years ago, he said.
“We recognized that this was a potential area of concern for our cancer programs and we started incorporating surgical oncology into our affiliate structure,” Dr. Mulkerin said. “We look at the quality outcomes of our partners on a quarterly basis. That drives our approach about which types of surgery gets triaged to come to the main institution and which types of surgeries can appropriately be done in community settings under our brand, and under our guidance.”
At H. Lee Moffitt Cancer Center & Research Institute, physicians travel from the headquarters to its partner hospitals to deliver care and work with doctors at each site. For example, Moffitt leaders are overseeing a program with Memorial Healthcare System in South Florida that focuses on malignant hematology and blood and marrow transplantation, said Louis Harrison, MD, chair for Moffitt’s radiation oncology department and vice president, chief partnership officer.
“These are real partnerships where we put our faculty and our know-how on the ground at these sites,” he said in an interview. “We feel like the only way to deliver care that is representative to Moffitt is to have Moffitt doctors deliver the care.”
The University of Texas MD Anderson Cancer Center, Houston, meanwhile, boasts a robust network of partner members, certified member hospitals, associate members, and affiliates. Partner members are U.S.-based relationships where member health systems integrate their clinical cancer care operations with MD Anderson, said Michael Kupferman, MD, senior vice president of clinical and academic network development at MD Anderson. Certified members receive assessments by MD Anderson and tailored recommendations for clinical quality improvements, while associate members stem from international clinical relationships with MD Anderson. Affiliates have a relationship with MD Anderson in one specialty- or modality-focused area, such as radiation oncology.
“All MD Anderson Cancer Network members operate independently from MD Anderson Cancer Center,” Dr. Kupferman said in an interview. “All cancer network members have access to our expertise and clinical knowledge to improve the level of cancer care in their communities.”
In terms of marketing the different types of network members, Dr. Kupferman said that MD Anderson collaborates with members on internal and external marketing and communications strategies to offer “best practices and guidance on how to best educate the alignment and benefits of the relationship to internal staff and local communities.”
Dr. Kupferman declined to directly comment on how surgical safety at MD Anderson’s member institutions is addressed or respond to the JAMA study findings. “We believe that our cancer network members strive to practice at a level higher than the national safety average, as evidenced by the consistent quality reviews we conduct with our members.”
An opportunity to improve
A key advantage to affiliate cancer centers is the expanded care access they can provide to patients, said Dr. Lichtenfeld. While some patients can bypass their community hospital and travel to a top-ranked cancer hospital for treatment, others do not have that capability.
“Some people will not leave their communities,” he said. “It would be wrong to take this research and point at bad doctors for not sending their patient [to a more specialized hospital]. Sometimes, its patients themselves, by choice or necessity, who can’t go somewhere else.”
Dr. Boffa emphasized that the recent research on safety presents an exciting opportunity for flagship institutions and their affiliates to analyze their structure and make improvements where necessary.
“The fact that [the hospitals] are already connected in some way is a huge advance; that’s half the battle,” Dr. Boffa said. “The next step is how do we distill what elements of care are transferable. How do we leverage this connection to share what makes the safer hospitals safer?”
Daniel Boffa, MD, was never able to shake the unfortunate incident from his mind. An acquaintance receiving cancer care at an affiliate center of a top-ranked cancer hospital had experienced a poor, and possibly preventable, outcome.
“As I learned more about the outcome, it became clear to me that the affiliate wasn’t prepared to handle a complication that was not unexpected,” said Dr. Boffa, a thoracic surgeon at Yale Cancer Center in New Haven, Conn. “When I talked to this individual and the people who helped make the decision for where care was going to be given, they kept saying over and over, ‘It says the name of a top-ranked hospital on the sign [of the affiliate], therefore it’s the same.’ ”
The incident compelled Dr. Boffa and colleagues to learn more about the safety at affiliate cancer centers. The result is an analysis that found that patients who underwent complex cancer surgery at affiliate hospitals were significantly more likely to die within 90 days, compared with patients receiving the same surgery at the flagship hospital. When the relative safety of each top-ranked cancer hospital was compared with its collective affiliates, the top-ranked hospital was safer than affiliates in 41 of 49 networks studied (JAMA Netw Open. 2019 Apr 12. doi: 10.1001/jamanetworkopen.2019.1912).
The analysis illustrates that a patient’s chances of surviving a complex cancer surgery are markedly lower at affiliates, compared with the hospital whose brand it shares, Dr. Boffa explained.
“Every patient and everybody that is supporting a patient in making these [care] decisions can’t assume the care is the same,” he said. “This is not to say that the affiliates are unsafe, they are just less safe than the top-ranked hospitals.”
The findings come as more top-ranked cancer hospital align with affiliate cancer centers and grow partnerships with smaller, community hospitals.
Leaders at these institutions say the partnerships expand access to care and enable regional centers to draw from the expertise at specialized cancer hospitals. However, in addition to safety concerns, the recent data pose questions about whether marketing by some institutions is creating inaccurate perceptions about the relationship between top hospitals and their affiliates. At the same time, it’s uncertain whether network affiliations really improve cost or quality, said Lesly Dossett, MD, an oncologist and researcher at the University of Michigan, Ann Arbor.
“Affiliation has the theoretical advantage of improving efficiency and quality across hospitals and facilitating regionalization of the most complex patients,” said Dr. Dossett, who wrote a commentary for JAMA on the subject. “An ideal network would provide the patient the most convenient access to the right specialist and service at the right time. Disadvantages are that patients and families can attribute quality and safety outcomes achieved at the flagship hospital to the smaller branded affiliate and decline to travel to the flagship, even though some services, like complex surgery, may be best delivered at the flagship.”
What’s an affiliate?
Part of the problem is the ambiguity surrounding the many different relationships among top-ranked cancer hospitals and associated institutions, said J. Leonard Lichtenfeld, MD, interim chief medical officer for the American Cancer Society. In some cases, the primary institution is closely aligned with an affiliate, sharing staff and collaborating on patient cases. In other instances, a reputable hospital offers its brand to a hospital in a distant location, and the relationship is more marketing and information-sharing based.
“Just because a name shows up on a building, doesn’t necessarily mean the same level of care is being provided at an affiliated institution,” Dr. Lichtenfeld said. “There are factors that neither you nor me can look into to determine how close the affiliation is. Sometimes, it can be a very tight relationship. Sometimes it can be a loose relationship, and it’s very hard to figure that out.”
In a survey of 1,010 patients, 94% of respondents felt that cancer care at a smaller hospital would improve after affiliating with a larger hospital specializing in cancer, and most patients expected physicians at the larger hospital to be involved considerably in the care of patients at the smaller hospital after affiliation (JAMA Oncol. 2018;4[7]:1008-9).
In another survey, 85% of patients said they would rather travel an hour for complex surgery at a larger hospital specializing in cancer, rather than a smaller local hospital. However, if the smaller hospital was affiliated with a top-ranked cancer hospital, 31% of respondents changed their preference to the smaller hospital, according to the analysis (Ann Surg Oncol. 2019 Mar;26[3]:732-8).
When asked to compare leading cancer hospitals and their smaller affiliates, 47% of respondents said they felt that surgical safety would be the same at both hospitals, 66% said that guideline compliance would be the same, and 53% of patients said they believed that cure rates would be the same at both institutions.
“A majority of the public feels when the brand is shared between a top-ranked hospital and a hospital in the community, the quality and safety is the same,” said Dr. Boffa, a coauthor of both survey studies. “The advertising differs for each affiliate, but there are certainly instances where the messaging can be misinterpreted. There are instances where there are billboards and advertisements where the implication is the community hospital to some degree has care that is similar to the main hospital.”
Hospitals: Collaborations beneficial
For the University of Wisconsin–Madison (UW) Carbone Cancer Center, its relationships with several community institutions have enhanced consistency among physician teams and provided new care opportunities for patients, said Dan Mulkerin, MD, regional director of UW’s regional cancer center network. Carbone includes 12 locales of service and four affiliates in various stages of maturity.
In some cases, UW physicians travel to the affiliate to help care for patients but refer surgeries back to the main institution. In other cases, UW surgical specialists operate jointly with local surgeons at the community hospital, according to Dr. Mulkerin.
The surgical safety of affiliates is an issue that UW started to address about 5 years ago, he said.
“We recognized that this was a potential area of concern for our cancer programs and we started incorporating surgical oncology into our affiliate structure,” Dr. Mulkerin said. “We look at the quality outcomes of our partners on a quarterly basis. That drives our approach about which types of surgery gets triaged to come to the main institution and which types of surgeries can appropriately be done in community settings under our brand, and under our guidance.”
At H. Lee Moffitt Cancer Center & Research Institute, physicians travel from the headquarters to its partner hospitals to deliver care and work with doctors at each site. For example, Moffitt leaders are overseeing a program with Memorial Healthcare System in South Florida that focuses on malignant hematology and blood and marrow transplantation, said Louis Harrison, MD, chair for Moffitt’s radiation oncology department and vice president, chief partnership officer.
“These are real partnerships where we put our faculty and our know-how on the ground at these sites,” he said in an interview. “We feel like the only way to deliver care that is representative to Moffitt is to have Moffitt doctors deliver the care.”
The University of Texas MD Anderson Cancer Center, Houston, meanwhile, boasts a robust network of partner members, certified member hospitals, associate members, and affiliates. Partner members are U.S.-based relationships where member health systems integrate their clinical cancer care operations with MD Anderson, said Michael Kupferman, MD, senior vice president of clinical and academic network development at MD Anderson. Certified members receive assessments by MD Anderson and tailored recommendations for clinical quality improvements, while associate members stem from international clinical relationships with MD Anderson. Affiliates have a relationship with MD Anderson in one specialty- or modality-focused area, such as radiation oncology.
“All MD Anderson Cancer Network members operate independently from MD Anderson Cancer Center,” Dr. Kupferman said in an interview. “All cancer network members have access to our expertise and clinical knowledge to improve the level of cancer care in their communities.”
In terms of marketing the different types of network members, Dr. Kupferman said that MD Anderson collaborates with members on internal and external marketing and communications strategies to offer “best practices and guidance on how to best educate the alignment and benefits of the relationship to internal staff and local communities.”
Dr. Kupferman declined to directly comment on how surgical safety at MD Anderson’s member institutions is addressed or respond to the JAMA study findings. “We believe that our cancer network members strive to practice at a level higher than the national safety average, as evidenced by the consistent quality reviews we conduct with our members.”
An opportunity to improve
A key advantage to affiliate cancer centers is the expanded care access they can provide to patients, said Dr. Lichtenfeld. While some patients can bypass their community hospital and travel to a top-ranked cancer hospital for treatment, others do not have that capability.
“Some people will not leave their communities,” he said. “It would be wrong to take this research and point at bad doctors for not sending their patient [to a more specialized hospital]. Sometimes, its patients themselves, by choice or necessity, who can’t go somewhere else.”
Dr. Boffa emphasized that the recent research on safety presents an exciting opportunity for flagship institutions and their affiliates to analyze their structure and make improvements where necessary.
“The fact that [the hospitals] are already connected in some way is a huge advance; that’s half the battle,” Dr. Boffa said. “The next step is how do we distill what elements of care are transferable. How do we leverage this connection to share what makes the safer hospitals safer?”
Daniel Boffa, MD, was never able to shake the unfortunate incident from his mind. An acquaintance receiving cancer care at an affiliate center of a top-ranked cancer hospital had experienced a poor, and possibly preventable, outcome.
“As I learned more about the outcome, it became clear to me that the affiliate wasn’t prepared to handle a complication that was not unexpected,” said Dr. Boffa, a thoracic surgeon at Yale Cancer Center in New Haven, Conn. “When I talked to this individual and the people who helped make the decision for where care was going to be given, they kept saying over and over, ‘It says the name of a top-ranked hospital on the sign [of the affiliate], therefore it’s the same.’ ”
The incident compelled Dr. Boffa and colleagues to learn more about the safety at affiliate cancer centers. The result is an analysis that found that patients who underwent complex cancer surgery at affiliate hospitals were significantly more likely to die within 90 days, compared with patients receiving the same surgery at the flagship hospital. When the relative safety of each top-ranked cancer hospital was compared with its collective affiliates, the top-ranked hospital was safer than affiliates in 41 of 49 networks studied (JAMA Netw Open. 2019 Apr 12. doi: 10.1001/jamanetworkopen.2019.1912).
The analysis illustrates that a patient’s chances of surviving a complex cancer surgery are markedly lower at affiliates, compared with the hospital whose brand it shares, Dr. Boffa explained.
“Every patient and everybody that is supporting a patient in making these [care] decisions can’t assume the care is the same,” he said. “This is not to say that the affiliates are unsafe, they are just less safe than the top-ranked hospitals.”
The findings come as more top-ranked cancer hospital align with affiliate cancer centers and grow partnerships with smaller, community hospitals.
Leaders at these institutions say the partnerships expand access to care and enable regional centers to draw from the expertise at specialized cancer hospitals. However, in addition to safety concerns, the recent data pose questions about whether marketing by some institutions is creating inaccurate perceptions about the relationship between top hospitals and their affiliates. At the same time, it’s uncertain whether network affiliations really improve cost or quality, said Lesly Dossett, MD, an oncologist and researcher at the University of Michigan, Ann Arbor.
“Affiliation has the theoretical advantage of improving efficiency and quality across hospitals and facilitating regionalization of the most complex patients,” said Dr. Dossett, who wrote a commentary for JAMA on the subject. “An ideal network would provide the patient the most convenient access to the right specialist and service at the right time. Disadvantages are that patients and families can attribute quality and safety outcomes achieved at the flagship hospital to the smaller branded affiliate and decline to travel to the flagship, even though some services, like complex surgery, may be best delivered at the flagship.”
What’s an affiliate?
Part of the problem is the ambiguity surrounding the many different relationships among top-ranked cancer hospitals and associated institutions, said J. Leonard Lichtenfeld, MD, interim chief medical officer for the American Cancer Society. In some cases, the primary institution is closely aligned with an affiliate, sharing staff and collaborating on patient cases. In other instances, a reputable hospital offers its brand to a hospital in a distant location, and the relationship is more marketing and information-sharing based.
“Just because a name shows up on a building, doesn’t necessarily mean the same level of care is being provided at an affiliated institution,” Dr. Lichtenfeld said. “There are factors that neither you nor me can look into to determine how close the affiliation is. Sometimes, it can be a very tight relationship. Sometimes it can be a loose relationship, and it’s very hard to figure that out.”
In a survey of 1,010 patients, 94% of respondents felt that cancer care at a smaller hospital would improve after affiliating with a larger hospital specializing in cancer, and most patients expected physicians at the larger hospital to be involved considerably in the care of patients at the smaller hospital after affiliation (JAMA Oncol. 2018;4[7]:1008-9).
In another survey, 85% of patients said they would rather travel an hour for complex surgery at a larger hospital specializing in cancer, rather than a smaller local hospital. However, if the smaller hospital was affiliated with a top-ranked cancer hospital, 31% of respondents changed their preference to the smaller hospital, according to the analysis (Ann Surg Oncol. 2019 Mar;26[3]:732-8).
When asked to compare leading cancer hospitals and their smaller affiliates, 47% of respondents said they felt that surgical safety would be the same at both hospitals, 66% said that guideline compliance would be the same, and 53% of patients said they believed that cure rates would be the same at both institutions.
“A majority of the public feels when the brand is shared between a top-ranked hospital and a hospital in the community, the quality and safety is the same,” said Dr. Boffa, a coauthor of both survey studies. “The advertising differs for each affiliate, but there are certainly instances where the messaging can be misinterpreted. There are instances where there are billboards and advertisements where the implication is the community hospital to some degree has care that is similar to the main hospital.”
Hospitals: Collaborations beneficial
For the University of Wisconsin–Madison (UW) Carbone Cancer Center, its relationships with several community institutions have enhanced consistency among physician teams and provided new care opportunities for patients, said Dan Mulkerin, MD, regional director of UW’s regional cancer center network. Carbone includes 12 locales of service and four affiliates in various stages of maturity.
In some cases, UW physicians travel to the affiliate to help care for patients but refer surgeries back to the main institution. In other cases, UW surgical specialists operate jointly with local surgeons at the community hospital, according to Dr. Mulkerin.
The surgical safety of affiliates is an issue that UW started to address about 5 years ago, he said.
“We recognized that this was a potential area of concern for our cancer programs and we started incorporating surgical oncology into our affiliate structure,” Dr. Mulkerin said. “We look at the quality outcomes of our partners on a quarterly basis. That drives our approach about which types of surgery gets triaged to come to the main institution and which types of surgeries can appropriately be done in community settings under our brand, and under our guidance.”
At H. Lee Moffitt Cancer Center & Research Institute, physicians travel from the headquarters to its partner hospitals to deliver care and work with doctors at each site. For example, Moffitt leaders are overseeing a program with Memorial Healthcare System in South Florida that focuses on malignant hematology and blood and marrow transplantation, said Louis Harrison, MD, chair for Moffitt’s radiation oncology department and vice president, chief partnership officer.
“These are real partnerships where we put our faculty and our know-how on the ground at these sites,” he said in an interview. “We feel like the only way to deliver care that is representative to Moffitt is to have Moffitt doctors deliver the care.”
The University of Texas MD Anderson Cancer Center, Houston, meanwhile, boasts a robust network of partner members, certified member hospitals, associate members, and affiliates. Partner members are U.S.-based relationships where member health systems integrate their clinical cancer care operations with MD Anderson, said Michael Kupferman, MD, senior vice president of clinical and academic network development at MD Anderson. Certified members receive assessments by MD Anderson and tailored recommendations for clinical quality improvements, while associate members stem from international clinical relationships with MD Anderson. Affiliates have a relationship with MD Anderson in one specialty- or modality-focused area, such as radiation oncology.
“All MD Anderson Cancer Network members operate independently from MD Anderson Cancer Center,” Dr. Kupferman said in an interview. “All cancer network members have access to our expertise and clinical knowledge to improve the level of cancer care in their communities.”
In terms of marketing the different types of network members, Dr. Kupferman said that MD Anderson collaborates with members on internal and external marketing and communications strategies to offer “best practices and guidance on how to best educate the alignment and benefits of the relationship to internal staff and local communities.”
Dr. Kupferman declined to directly comment on how surgical safety at MD Anderson’s member institutions is addressed or respond to the JAMA study findings. “We believe that our cancer network members strive to practice at a level higher than the national safety average, as evidenced by the consistent quality reviews we conduct with our members.”
An opportunity to improve
A key advantage to affiliate cancer centers is the expanded care access they can provide to patients, said Dr. Lichtenfeld. While some patients can bypass their community hospital and travel to a top-ranked cancer hospital for treatment, others do not have that capability.
“Some people will not leave their communities,” he said. “It would be wrong to take this research and point at bad doctors for not sending their patient [to a more specialized hospital]. Sometimes, its patients themselves, by choice or necessity, who can’t go somewhere else.”
Dr. Boffa emphasized that the recent research on safety presents an exciting opportunity for flagship institutions and their affiliates to analyze their structure and make improvements where necessary.
“The fact that [the hospitals] are already connected in some way is a huge advance; that’s half the battle,” Dr. Boffa said. “The next step is how do we distill what elements of care are transferable. How do we leverage this connection to share what makes the safer hospitals safer?”
Topical ruxolitinib looks good for facial vitiligo, in phase 2 study
MILAN – Targeting the Janus kinase (JAK) 1 and 2 pathways in vitiligo resulted in significant reduction of facial depigmentation after 24 weeks of treatment, in a phase 2b trial of topical ruxolitinib cream.
compared with vehicle alone, said David Rosmarin, MD, speaking in a late-breaking abstracts session at the World Congress of Dermatology.
The highest response rate was seen with a higher dose: Among patients receiving ruxolitinib cream 1.5% once daily, 50% met the 50% clearing mark at 24 weeks, as did 45.5% of those with twice-daily 1.5% dosing of the 1.5% formulation. At 24 weeks, 3.1% of those receiving vehicle had 50% facial vitiligo resolution (P less than .0001, compared with vehicle for both doses).
Vitiligo affects about 3,000,000 people in the United States, and it is a plausible treatment target for the JAK inhibitor ruxolitinib, explained Dr. Rosmarin, a dermatologist at Tufts University, Boston. “Interferon-gamma, signaling through JAK1 and JAK2, is central to the pathogenesis of vitiligo,” he said. “Ruxolitinib is a potent inhibitor of JAK1 and JAK2, so it made sense to investigate it as a treatment for vitiligo.”
The 24-month randomized, double-blind, vehicle-controlled phase 2 study of ruxolitinib cream for vitiligo compared the vehicle to four different concentrations of ruxolitinib during the first phase of the study. For the first 24 weeks, patients were randomized to receive vehicle twice daily, or various doses of ruxolitinib ranging from 0.15% once daily to 1.5% twice daily.
At this point, the study’s primary endpoint was assessed, with investigators comparing the proportion of patients treated with ruxolitinib who had at least 50% improvement in facial repigmentation from baseline on the Facial Vitiligo Area Scoring Index (F-VASI50) compared with those who received vehicle. A secondary endpoint, also assessed at week 24, was the proportion of patients who were clear, or almost clear, of facial vitiligo; safety and tolerability were also assessed.
In addition to the F-VASI50 measure, Dr. Rosmarin and his coinvestigators also tracked 75% facial clearing (F-VASI75). Here, the 1.5% twice daily regimen topped the others, with 30% of those receiving that dose achieving F-VASI75, compared with almost 10%-17% of those on other doses.
Using another measure, More than one-third of patients using ruxolitinib (35.3%) had clear (no signs of vitiligo) or almost clear (only specks of depigmentation) facial skin at week 24, according to a clinician assessment tool. No patients on placebo had clear or almost clear facial skin at that point. “It is my hope that with continued use beyond week 24, more patients will meet this very stringent endpoint,” Dr. Rosmarin said.
The safety profile was good, with no serious treatment-related adverse events, and no application site reactions that reached clinical significance, although numerically more patients reported acne with ruxolitinib than with vehicle alone.
In the trial, patients aged 18-75 years with vitiligo were eligible if they had facial depigmentation that constituted at least half of their body surface area (BSA), as well as depigmentation of at least 3% of BSA on nonfacial areas. Patients were excluded if they had another dermatologic disease, infection, prior JAK inhibitor therapy, or recent use of biologic or experimental drugs, laser or light-based treatments, or immunomodulators. Of the 157 patients who were randomized, 18 patients (11.5%) had discontinued treatment by week 24, with 3 patients stopping for adverse events, 3 for protocol deviation or noncompliance, and 10 withdrawals. Two patients were lost to follow-up; all patients were included in analysis of the primary and secondary endpoints.
In the second year of the study, investigators rerandomized patients who had been receiving vehicle to an active arm of the study, and patients who had less than 25% improvement on a facial vitiligo scoring scale were rerandomized to one of the different doses. Twenty-eight weeks after rerandomization, all participants were given the opportunity to participate in a year-long open-label extension, receiving 1.5% ruxolitinib cream twice daily. Phototherapy was allowed in the extension arm, but not in the first year of the study.
Data beyond 24 weeks have not yet been reported, and the 2-year study plan acknowledged that “repigmentation takes a while,” Dr. Rosmarin said. He added that patients were allowed to use the study drug on body vitiligo as well, and many saw improvement there, although these results weren’t tracked in the study. “This isn’t a drug that’s meant just for the face,” he said.
Dr. Rosmarin and his coauthors reported financial arrangements with several pharmaceutical companies, including Incyte, which funded the study. An oral formulation of ruxolitinib (Jakafi), marketed by Incyte, was approved by the Food and Drug Administration in 2011, for myelofibrosis, and was recently approved for steroid-refractory acute graft-versus-host disease in adults and children aged 12 years and older.
MILAN – Targeting the Janus kinase (JAK) 1 and 2 pathways in vitiligo resulted in significant reduction of facial depigmentation after 24 weeks of treatment, in a phase 2b trial of topical ruxolitinib cream.
compared with vehicle alone, said David Rosmarin, MD, speaking in a late-breaking abstracts session at the World Congress of Dermatology.
The highest response rate was seen with a higher dose: Among patients receiving ruxolitinib cream 1.5% once daily, 50% met the 50% clearing mark at 24 weeks, as did 45.5% of those with twice-daily 1.5% dosing of the 1.5% formulation. At 24 weeks, 3.1% of those receiving vehicle had 50% facial vitiligo resolution (P less than .0001, compared with vehicle for both doses).
Vitiligo affects about 3,000,000 people in the United States, and it is a plausible treatment target for the JAK inhibitor ruxolitinib, explained Dr. Rosmarin, a dermatologist at Tufts University, Boston. “Interferon-gamma, signaling through JAK1 and JAK2, is central to the pathogenesis of vitiligo,” he said. “Ruxolitinib is a potent inhibitor of JAK1 and JAK2, so it made sense to investigate it as a treatment for vitiligo.”
The 24-month randomized, double-blind, vehicle-controlled phase 2 study of ruxolitinib cream for vitiligo compared the vehicle to four different concentrations of ruxolitinib during the first phase of the study. For the first 24 weeks, patients were randomized to receive vehicle twice daily, or various doses of ruxolitinib ranging from 0.15% once daily to 1.5% twice daily.
At this point, the study’s primary endpoint was assessed, with investigators comparing the proportion of patients treated with ruxolitinib who had at least 50% improvement in facial repigmentation from baseline on the Facial Vitiligo Area Scoring Index (F-VASI50) compared with those who received vehicle. A secondary endpoint, also assessed at week 24, was the proportion of patients who were clear, or almost clear, of facial vitiligo; safety and tolerability were also assessed.
In addition to the F-VASI50 measure, Dr. Rosmarin and his coinvestigators also tracked 75% facial clearing (F-VASI75). Here, the 1.5% twice daily regimen topped the others, with 30% of those receiving that dose achieving F-VASI75, compared with almost 10%-17% of those on other doses.
Using another measure, More than one-third of patients using ruxolitinib (35.3%) had clear (no signs of vitiligo) or almost clear (only specks of depigmentation) facial skin at week 24, according to a clinician assessment tool. No patients on placebo had clear or almost clear facial skin at that point. “It is my hope that with continued use beyond week 24, more patients will meet this very stringent endpoint,” Dr. Rosmarin said.
The safety profile was good, with no serious treatment-related adverse events, and no application site reactions that reached clinical significance, although numerically more patients reported acne with ruxolitinib than with vehicle alone.
In the trial, patients aged 18-75 years with vitiligo were eligible if they had facial depigmentation that constituted at least half of their body surface area (BSA), as well as depigmentation of at least 3% of BSA on nonfacial areas. Patients were excluded if they had another dermatologic disease, infection, prior JAK inhibitor therapy, or recent use of biologic or experimental drugs, laser or light-based treatments, or immunomodulators. Of the 157 patients who were randomized, 18 patients (11.5%) had discontinued treatment by week 24, with 3 patients stopping for adverse events, 3 for protocol deviation or noncompliance, and 10 withdrawals. Two patients were lost to follow-up; all patients were included in analysis of the primary and secondary endpoints.
In the second year of the study, investigators rerandomized patients who had been receiving vehicle to an active arm of the study, and patients who had less than 25% improvement on a facial vitiligo scoring scale were rerandomized to one of the different doses. Twenty-eight weeks after rerandomization, all participants were given the opportunity to participate in a year-long open-label extension, receiving 1.5% ruxolitinib cream twice daily. Phototherapy was allowed in the extension arm, but not in the first year of the study.
Data beyond 24 weeks have not yet been reported, and the 2-year study plan acknowledged that “repigmentation takes a while,” Dr. Rosmarin said. He added that patients were allowed to use the study drug on body vitiligo as well, and many saw improvement there, although these results weren’t tracked in the study. “This isn’t a drug that’s meant just for the face,” he said.
Dr. Rosmarin and his coauthors reported financial arrangements with several pharmaceutical companies, including Incyte, which funded the study. An oral formulation of ruxolitinib (Jakafi), marketed by Incyte, was approved by the Food and Drug Administration in 2011, for myelofibrosis, and was recently approved for steroid-refractory acute graft-versus-host disease in adults and children aged 12 years and older.
MILAN – Targeting the Janus kinase (JAK) 1 and 2 pathways in vitiligo resulted in significant reduction of facial depigmentation after 24 weeks of treatment, in a phase 2b trial of topical ruxolitinib cream.
compared with vehicle alone, said David Rosmarin, MD, speaking in a late-breaking abstracts session at the World Congress of Dermatology.
The highest response rate was seen with a higher dose: Among patients receiving ruxolitinib cream 1.5% once daily, 50% met the 50% clearing mark at 24 weeks, as did 45.5% of those with twice-daily 1.5% dosing of the 1.5% formulation. At 24 weeks, 3.1% of those receiving vehicle had 50% facial vitiligo resolution (P less than .0001, compared with vehicle for both doses).
Vitiligo affects about 3,000,000 people in the United States, and it is a plausible treatment target for the JAK inhibitor ruxolitinib, explained Dr. Rosmarin, a dermatologist at Tufts University, Boston. “Interferon-gamma, signaling through JAK1 and JAK2, is central to the pathogenesis of vitiligo,” he said. “Ruxolitinib is a potent inhibitor of JAK1 and JAK2, so it made sense to investigate it as a treatment for vitiligo.”
The 24-month randomized, double-blind, vehicle-controlled phase 2 study of ruxolitinib cream for vitiligo compared the vehicle to four different concentrations of ruxolitinib during the first phase of the study. For the first 24 weeks, patients were randomized to receive vehicle twice daily, or various doses of ruxolitinib ranging from 0.15% once daily to 1.5% twice daily.
At this point, the study’s primary endpoint was assessed, with investigators comparing the proportion of patients treated with ruxolitinib who had at least 50% improvement in facial repigmentation from baseline on the Facial Vitiligo Area Scoring Index (F-VASI50) compared with those who received vehicle. A secondary endpoint, also assessed at week 24, was the proportion of patients who were clear, or almost clear, of facial vitiligo; safety and tolerability were also assessed.
In addition to the F-VASI50 measure, Dr. Rosmarin and his coinvestigators also tracked 75% facial clearing (F-VASI75). Here, the 1.5% twice daily regimen topped the others, with 30% of those receiving that dose achieving F-VASI75, compared with almost 10%-17% of those on other doses.
Using another measure, More than one-third of patients using ruxolitinib (35.3%) had clear (no signs of vitiligo) or almost clear (only specks of depigmentation) facial skin at week 24, according to a clinician assessment tool. No patients on placebo had clear or almost clear facial skin at that point. “It is my hope that with continued use beyond week 24, more patients will meet this very stringent endpoint,” Dr. Rosmarin said.
The safety profile was good, with no serious treatment-related adverse events, and no application site reactions that reached clinical significance, although numerically more patients reported acne with ruxolitinib than with vehicle alone.
In the trial, patients aged 18-75 years with vitiligo were eligible if they had facial depigmentation that constituted at least half of their body surface area (BSA), as well as depigmentation of at least 3% of BSA on nonfacial areas. Patients were excluded if they had another dermatologic disease, infection, prior JAK inhibitor therapy, or recent use of biologic or experimental drugs, laser or light-based treatments, or immunomodulators. Of the 157 patients who were randomized, 18 patients (11.5%) had discontinued treatment by week 24, with 3 patients stopping for adverse events, 3 for protocol deviation or noncompliance, and 10 withdrawals. Two patients were lost to follow-up; all patients were included in analysis of the primary and secondary endpoints.
In the second year of the study, investigators rerandomized patients who had been receiving vehicle to an active arm of the study, and patients who had less than 25% improvement on a facial vitiligo scoring scale were rerandomized to one of the different doses. Twenty-eight weeks after rerandomization, all participants were given the opportunity to participate in a year-long open-label extension, receiving 1.5% ruxolitinib cream twice daily. Phototherapy was allowed in the extension arm, but not in the first year of the study.
Data beyond 24 weeks have not yet been reported, and the 2-year study plan acknowledged that “repigmentation takes a while,” Dr. Rosmarin said. He added that patients were allowed to use the study drug on body vitiligo as well, and many saw improvement there, although these results weren’t tracked in the study. “This isn’t a drug that’s meant just for the face,” he said.
Dr. Rosmarin and his coauthors reported financial arrangements with several pharmaceutical companies, including Incyte, which funded the study. An oral formulation of ruxolitinib (Jakafi), marketed by Incyte, was approved by the Food and Drug Administration in 2011, for myelofibrosis, and was recently approved for steroid-refractory acute graft-versus-host disease in adults and children aged 12 years and older.
REPORTING FROM WCD2019
‘Robust antitumor immune responses’ observed in pediatric ALL
Pediatric acute lymphoblastic leukemia (ALL) may be more vulnerable to immunotherapies than previously thought, according to researchers.
Prior studies suggested that tumors with a low mutational burden don’t elicit strong antitumor responses and therefore aren’t very susceptible to immunotherapy.
Now, researchers have found evidence to suggest that pediatric ALL induces “robust antitumor immune responses” despite a low mutational burden. The investigators identified tumor-associated CD8+ T cells that responded to 86% of neoantigens tested and recognized 68% of neoepitopes tested.
Anthony E. Zamora, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and colleagues recounted these findings in Science Translational Medicine.
The researchers analyzed samples from pediatric patients with ETV-associated ALL (n = 9) or ERG-associated ALL (n = 2) to determine how endogenous CD8+ T cells respond to patient-specific cancer neoantigens.
The investigators first assessed the ability of tumor-specific mutations and gene fusions to generate neoepitopes, or neoantigens predicted to bind patient-specific human leukocyte antigen (HLA) proteins. The team identified 5-28 neoepitopes per patient, including epitopes that spanned the fusion junction in patients with ETV6-RUNX1 fusions.
The researchers then tested whether CD8+ tumor infiltrating lymphocytes (TILs) were directly responsive to mutated neoepitopes. They observed cytokine responses across patient samples, noting that 31 of the 36 putative neoantigens tested (86%) were “immunogenic and capable of inducing robust cytokine responses.”
Next, the investigators mapped TIL responses to specific epitopes using patient-specific tetramers that corresponded to the previously identified neoepitopes. Seventeen of the 25 patient-specific tetramers (68%) bound to TILs above the background set by irrelevant HLA-matched tetramers.
“Within those responses, we observed immunodominance hierarchies among the distinct TIL populations, with a majority of tetramer-bound CD8+ T cells restricted to one or two putative neoepitopes,” the researchers noted.
The team also pointed out that seven of nine patients tested had CD8+ T cells that responded to ETV6-RUNX1.
Finally, the investigators performed transcriptional profiling of ALL-specific CD8+ TILs to assess inter- and intrapatient heterogeneity. The team identified three hierarchical clusters, which were characterized by transcriptional factors and regulators associated with:
- Functional effector CD8+ T cells (TBX21 and EOMES).
- Dysfunctional CD8+ T cells (STAT1/3/4, NR4A2/3, and BCL6).
- Exhausted CD8+ T cells (EOMES, MAF, PRDM1, and BATF).
Considering these findings together, the researchers concluded that “pediatric ALL elicits a potent neoepitope-specific CD8+ T-cell response.” Therefore, adoptive T-cell, monoclonal antibody, and targeted T-cell receptor therapies “should be explored” in pediatric ALL.
This research was supported by the National Institutes of Health, National Cancer Institute, National Institute of General Medical Sciences, Key for a Cure Foundation, and American Lebanese Syrian Associated Charities. The researchers disclosed patent applications and relationships with Pfizer, Amgen, and other companies.
SOURCE: Zamora AE et al. Sci. Transl. Med. 2019 Jun 26. doi: 10.1126/scitranslmed.aat8549.
Pediatric acute lymphoblastic leukemia (ALL) may be more vulnerable to immunotherapies than previously thought, according to researchers.
Prior studies suggested that tumors with a low mutational burden don’t elicit strong antitumor responses and therefore aren’t very susceptible to immunotherapy.
Now, researchers have found evidence to suggest that pediatric ALL induces “robust antitumor immune responses” despite a low mutational burden. The investigators identified tumor-associated CD8+ T cells that responded to 86% of neoantigens tested and recognized 68% of neoepitopes tested.
Anthony E. Zamora, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and colleagues recounted these findings in Science Translational Medicine.
The researchers analyzed samples from pediatric patients with ETV-associated ALL (n = 9) or ERG-associated ALL (n = 2) to determine how endogenous CD8+ T cells respond to patient-specific cancer neoantigens.
The investigators first assessed the ability of tumor-specific mutations and gene fusions to generate neoepitopes, or neoantigens predicted to bind patient-specific human leukocyte antigen (HLA) proteins. The team identified 5-28 neoepitopes per patient, including epitopes that spanned the fusion junction in patients with ETV6-RUNX1 fusions.
The researchers then tested whether CD8+ tumor infiltrating lymphocytes (TILs) were directly responsive to mutated neoepitopes. They observed cytokine responses across patient samples, noting that 31 of the 36 putative neoantigens tested (86%) were “immunogenic and capable of inducing robust cytokine responses.”
Next, the investigators mapped TIL responses to specific epitopes using patient-specific tetramers that corresponded to the previously identified neoepitopes. Seventeen of the 25 patient-specific tetramers (68%) bound to TILs above the background set by irrelevant HLA-matched tetramers.
“Within those responses, we observed immunodominance hierarchies among the distinct TIL populations, with a majority of tetramer-bound CD8+ T cells restricted to one or two putative neoepitopes,” the researchers noted.
The team also pointed out that seven of nine patients tested had CD8+ T cells that responded to ETV6-RUNX1.
Finally, the investigators performed transcriptional profiling of ALL-specific CD8+ TILs to assess inter- and intrapatient heterogeneity. The team identified three hierarchical clusters, which were characterized by transcriptional factors and regulators associated with:
- Functional effector CD8+ T cells (TBX21 and EOMES).
- Dysfunctional CD8+ T cells (STAT1/3/4, NR4A2/3, and BCL6).
- Exhausted CD8+ T cells (EOMES, MAF, PRDM1, and BATF).
Considering these findings together, the researchers concluded that “pediatric ALL elicits a potent neoepitope-specific CD8+ T-cell response.” Therefore, adoptive T-cell, monoclonal antibody, and targeted T-cell receptor therapies “should be explored” in pediatric ALL.
This research was supported by the National Institutes of Health, National Cancer Institute, National Institute of General Medical Sciences, Key for a Cure Foundation, and American Lebanese Syrian Associated Charities. The researchers disclosed patent applications and relationships with Pfizer, Amgen, and other companies.
SOURCE: Zamora AE et al. Sci. Transl. Med. 2019 Jun 26. doi: 10.1126/scitranslmed.aat8549.
Pediatric acute lymphoblastic leukemia (ALL) may be more vulnerable to immunotherapies than previously thought, according to researchers.
Prior studies suggested that tumors with a low mutational burden don’t elicit strong antitumor responses and therefore aren’t very susceptible to immunotherapy.
Now, researchers have found evidence to suggest that pediatric ALL induces “robust antitumor immune responses” despite a low mutational burden. The investigators identified tumor-associated CD8+ T cells that responded to 86% of neoantigens tested and recognized 68% of neoepitopes tested.
Anthony E. Zamora, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and colleagues recounted these findings in Science Translational Medicine.
The researchers analyzed samples from pediatric patients with ETV-associated ALL (n = 9) or ERG-associated ALL (n = 2) to determine how endogenous CD8+ T cells respond to patient-specific cancer neoantigens.
The investigators first assessed the ability of tumor-specific mutations and gene fusions to generate neoepitopes, or neoantigens predicted to bind patient-specific human leukocyte antigen (HLA) proteins. The team identified 5-28 neoepitopes per patient, including epitopes that spanned the fusion junction in patients with ETV6-RUNX1 fusions.
The researchers then tested whether CD8+ tumor infiltrating lymphocytes (TILs) were directly responsive to mutated neoepitopes. They observed cytokine responses across patient samples, noting that 31 of the 36 putative neoantigens tested (86%) were “immunogenic and capable of inducing robust cytokine responses.”
Next, the investigators mapped TIL responses to specific epitopes using patient-specific tetramers that corresponded to the previously identified neoepitopes. Seventeen of the 25 patient-specific tetramers (68%) bound to TILs above the background set by irrelevant HLA-matched tetramers.
“Within those responses, we observed immunodominance hierarchies among the distinct TIL populations, with a majority of tetramer-bound CD8+ T cells restricted to one or two putative neoepitopes,” the researchers noted.
The team also pointed out that seven of nine patients tested had CD8+ T cells that responded to ETV6-RUNX1.
Finally, the investigators performed transcriptional profiling of ALL-specific CD8+ TILs to assess inter- and intrapatient heterogeneity. The team identified three hierarchical clusters, which were characterized by transcriptional factors and regulators associated with:
- Functional effector CD8+ T cells (TBX21 and EOMES).
- Dysfunctional CD8+ T cells (STAT1/3/4, NR4A2/3, and BCL6).
- Exhausted CD8+ T cells (EOMES, MAF, PRDM1, and BATF).
Considering these findings together, the researchers concluded that “pediatric ALL elicits a potent neoepitope-specific CD8+ T-cell response.” Therefore, adoptive T-cell, monoclonal antibody, and targeted T-cell receptor therapies “should be explored” in pediatric ALL.
This research was supported by the National Institutes of Health, National Cancer Institute, National Institute of General Medical Sciences, Key for a Cure Foundation, and American Lebanese Syrian Associated Charities. The researchers disclosed patent applications and relationships with Pfizer, Amgen, and other companies.
SOURCE: Zamora AE et al. Sci. Transl. Med. 2019 Jun 26. doi: 10.1126/scitranslmed.aat8549.
FROM SCIENCE TRANSLATIONAL MEDICINE
Key clinical point: Preclinical research suggests pediatric acute lymphoblastic leukemia (ALL) induces “robust antitumor immune responses” despite a low mutational burden.
Major finding: Investigators identified tumor-associated CD8+ T cells that responded to 86% of neoantigens tested and recognized 68% of neoepitopes tested.
Study details: Analysis of samples from pediatric patients with ETV-associated ALL (n = 9) or ERG-associated ALL (n = 2).
Disclosures: The research was supported by the National Institutes of Health, National Cancer Institute, National Institute of General Medical Sciences, Key for a Cure Foundation, and American Lebanese Syrian Associated Charities. The researchers disclosed patent applications and relationships with Pfizer, Amgen, and other companies.
Source: Zamora AE et al. Sci. Transl. Med. 2019 Jun 26. doi: 10.1126/scitranslmed.aat8549.
Leflunomide added to glucocorticoids reduces relapse in IgG4-related disease
MADRID – The addition of leflunomide to standard glucocorticoids (GCs) in the treatment of IgG4-related disease increases the median duration of response, reduces the proportion of patients with relapse within 12 months, and permits GCs to be tapered, according to results of a randomized trial presented at the European Congress of Rheumatology.
“The rate of adverse events with the addition of leflunomide was numerically higher, but there were no significant differences in risks of any specific adverse event,” reported Feng Huang, MD, of the department of rheumatology at Chinese People’s Liberation Army General Hospital in Beijing.
GCs are highly effective in IgG4-related disease, which is an autoimmune process driven by elevated concentrations of the antibody IgG4 in the tissue of affected organs and in the serum. It has been described in a broad array of sites, including the heart, lung, kidneys, and meninges. It has been widely recognized only in the last 10 years, according to Dr. Huang. Although most patients respond to GCs, he said the problem is that about 50% of patients relapse within 12 months and more than 90% within 3 years.
This randomized, controlled study was conducted after positive results were observed with leflunomide in a small, uncontrolled pilot study published several years ago (Intern Med J. 2017 Jun;47[6]:680-9. doi: 10.1111/imj.13430). In this randomized trial, the objectives were to confirm that leflunomide extends the relapse-free period and has acceptable safety relative to GC alone.
Patients with confirmed IgG4-related disease were enrolled. Patients randomized to GC were started on 0.5 to 0.8 mg/kg per day. A predefined taper regimen was employed in those with symptom control. Those randomized to the experimental arm received GC in the same dose and schedule plus 20 mg/day of leflunomide.
The 33 patients in each group were well matched at baseline for age, comorbidities, and disease severity.
At the end of 12 months, 50% of those treated with GC alone versus 21.2% of those treated with GC plus leflunomide had relapse. That translated into a significantly higher hazard ratio (HR) for relapse in the GC monotherapy group (HR, 1.75; P = .034).
The mean duration of remission was 7 months on the combination versus 3 months on GC alone. Dr. Huang also reported a significantly higher proportion of complete responses in the group receiving the combination.
In addition, “more patients on the combination therapy were able to adhere to the steroid-tapering schedule without relapse,” Dr. Huang reported. The rate of 54.5% of patients on combination therapy who were able to reach a daily GC dose of 5 mg/day or less proved significantly higher than the 18.2% rate seen with GC alone (P = .002).
Adverse events were reported by 54% of those on the combination versus 42% of those on monotherapy, but this difference did not reach statistical significance. The biggest differences in adverse events were the proportions of patients with infections (18.2% vs. 12.1%) and elevated liver enzymes (12.1% vs. 3.0%), both of which were more common in the combination therapy group. Neither of these differences was statistically significant.
Of patients with relapses, the most common organs involved were the salivary gland, the pancreas, and the bile ducts, each accounting for relapse in five patients. Other organs in which relapse occurred included the lacrimal gland and the skin. There were three cases of relapse characterized by retroperitoneal fibrosis.
Over the course of follow-up, new-onset diabetes mellitus occurred in 21.2% and 27.3% of the combination and GC-only groups, respectively. This difference also did not reach statistical significance.
Although this study was small with an open-label design, Dr. Huang said the data strongly suggest that a combination of leflunomide and GC is superior to GC alone. Based on these results, he said a starting dose of 20 mg/day of leflunomide is a reasonable standard in this setting.
Dr. Huang and colleagues reported no potential conflicts of interest.
SOURCE: Wang Y et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):157. Abstract OPO164, doi: 10.1136/annrheumdis-2019-eular.5717
MADRID – The addition of leflunomide to standard glucocorticoids (GCs) in the treatment of IgG4-related disease increases the median duration of response, reduces the proportion of patients with relapse within 12 months, and permits GCs to be tapered, according to results of a randomized trial presented at the European Congress of Rheumatology.
“The rate of adverse events with the addition of leflunomide was numerically higher, but there were no significant differences in risks of any specific adverse event,” reported Feng Huang, MD, of the department of rheumatology at Chinese People’s Liberation Army General Hospital in Beijing.
GCs are highly effective in IgG4-related disease, which is an autoimmune process driven by elevated concentrations of the antibody IgG4 in the tissue of affected organs and in the serum. It has been described in a broad array of sites, including the heart, lung, kidneys, and meninges. It has been widely recognized only in the last 10 years, according to Dr. Huang. Although most patients respond to GCs, he said the problem is that about 50% of patients relapse within 12 months and more than 90% within 3 years.
This randomized, controlled study was conducted after positive results were observed with leflunomide in a small, uncontrolled pilot study published several years ago (Intern Med J. 2017 Jun;47[6]:680-9. doi: 10.1111/imj.13430). In this randomized trial, the objectives were to confirm that leflunomide extends the relapse-free period and has acceptable safety relative to GC alone.
Patients with confirmed IgG4-related disease were enrolled. Patients randomized to GC were started on 0.5 to 0.8 mg/kg per day. A predefined taper regimen was employed in those with symptom control. Those randomized to the experimental arm received GC in the same dose and schedule plus 20 mg/day of leflunomide.
The 33 patients in each group were well matched at baseline for age, comorbidities, and disease severity.
At the end of 12 months, 50% of those treated with GC alone versus 21.2% of those treated with GC plus leflunomide had relapse. That translated into a significantly higher hazard ratio (HR) for relapse in the GC monotherapy group (HR, 1.75; P = .034).
The mean duration of remission was 7 months on the combination versus 3 months on GC alone. Dr. Huang also reported a significantly higher proportion of complete responses in the group receiving the combination.
In addition, “more patients on the combination therapy were able to adhere to the steroid-tapering schedule without relapse,” Dr. Huang reported. The rate of 54.5% of patients on combination therapy who were able to reach a daily GC dose of 5 mg/day or less proved significantly higher than the 18.2% rate seen with GC alone (P = .002).
Adverse events were reported by 54% of those on the combination versus 42% of those on monotherapy, but this difference did not reach statistical significance. The biggest differences in adverse events were the proportions of patients with infections (18.2% vs. 12.1%) and elevated liver enzymes (12.1% vs. 3.0%), both of which were more common in the combination therapy group. Neither of these differences was statistically significant.
Of patients with relapses, the most common organs involved were the salivary gland, the pancreas, and the bile ducts, each accounting for relapse in five patients. Other organs in which relapse occurred included the lacrimal gland and the skin. There were three cases of relapse characterized by retroperitoneal fibrosis.
Over the course of follow-up, new-onset diabetes mellitus occurred in 21.2% and 27.3% of the combination and GC-only groups, respectively. This difference also did not reach statistical significance.
Although this study was small with an open-label design, Dr. Huang said the data strongly suggest that a combination of leflunomide and GC is superior to GC alone. Based on these results, he said a starting dose of 20 mg/day of leflunomide is a reasonable standard in this setting.
Dr. Huang and colleagues reported no potential conflicts of interest.
SOURCE: Wang Y et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):157. Abstract OPO164, doi: 10.1136/annrheumdis-2019-eular.5717
MADRID – The addition of leflunomide to standard glucocorticoids (GCs) in the treatment of IgG4-related disease increases the median duration of response, reduces the proportion of patients with relapse within 12 months, and permits GCs to be tapered, according to results of a randomized trial presented at the European Congress of Rheumatology.
“The rate of adverse events with the addition of leflunomide was numerically higher, but there were no significant differences in risks of any specific adverse event,” reported Feng Huang, MD, of the department of rheumatology at Chinese People’s Liberation Army General Hospital in Beijing.
GCs are highly effective in IgG4-related disease, which is an autoimmune process driven by elevated concentrations of the antibody IgG4 in the tissue of affected organs and in the serum. It has been described in a broad array of sites, including the heart, lung, kidneys, and meninges. It has been widely recognized only in the last 10 years, according to Dr. Huang. Although most patients respond to GCs, he said the problem is that about 50% of patients relapse within 12 months and more than 90% within 3 years.
This randomized, controlled study was conducted after positive results were observed with leflunomide in a small, uncontrolled pilot study published several years ago (Intern Med J. 2017 Jun;47[6]:680-9. doi: 10.1111/imj.13430). In this randomized trial, the objectives were to confirm that leflunomide extends the relapse-free period and has acceptable safety relative to GC alone.
Patients with confirmed IgG4-related disease were enrolled. Patients randomized to GC were started on 0.5 to 0.8 mg/kg per day. A predefined taper regimen was employed in those with symptom control. Those randomized to the experimental arm received GC in the same dose and schedule plus 20 mg/day of leflunomide.
The 33 patients in each group were well matched at baseline for age, comorbidities, and disease severity.
At the end of 12 months, 50% of those treated with GC alone versus 21.2% of those treated with GC plus leflunomide had relapse. That translated into a significantly higher hazard ratio (HR) for relapse in the GC monotherapy group (HR, 1.75; P = .034).
The mean duration of remission was 7 months on the combination versus 3 months on GC alone. Dr. Huang also reported a significantly higher proportion of complete responses in the group receiving the combination.
In addition, “more patients on the combination therapy were able to adhere to the steroid-tapering schedule without relapse,” Dr. Huang reported. The rate of 54.5% of patients on combination therapy who were able to reach a daily GC dose of 5 mg/day or less proved significantly higher than the 18.2% rate seen with GC alone (P = .002).
Adverse events were reported by 54% of those on the combination versus 42% of those on monotherapy, but this difference did not reach statistical significance. The biggest differences in adverse events were the proportions of patients with infections (18.2% vs. 12.1%) and elevated liver enzymes (12.1% vs. 3.0%), both of which were more common in the combination therapy group. Neither of these differences was statistically significant.
Of patients with relapses, the most common organs involved were the salivary gland, the pancreas, and the bile ducts, each accounting for relapse in five patients. Other organs in which relapse occurred included the lacrimal gland and the skin. There were three cases of relapse characterized by retroperitoneal fibrosis.
Over the course of follow-up, new-onset diabetes mellitus occurred in 21.2% and 27.3% of the combination and GC-only groups, respectively. This difference also did not reach statistical significance.
Although this study was small with an open-label design, Dr. Huang said the data strongly suggest that a combination of leflunomide and GC is superior to GC alone. Based on these results, he said a starting dose of 20 mg/day of leflunomide is a reasonable standard in this setting.
Dr. Huang and colleagues reported no potential conflicts of interest.
SOURCE: Wang Y et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):157. Abstract OPO164, doi: 10.1136/annrheumdis-2019-eular.5717
REPORTING FROM EULAR 2019 CONGRESS
Becoming a high-value care physician
‘Culture shift’ comes from collective efforts
It’s Monday morning, and Mrs. Jones still has abdominal pain. Your ward team decides to order a CT. On chart review you notice she’s had three other abdominal CTs for the same indication this year. How did this happen? What should you do?
High-value care has been defined by the Institute of Medicine as “the best care for the patient, with the optimal result for the circumstances, delivered at the right price.”1 With an estimated $700 billion dollars – 30% of medical expenditures – spent on wasted care, there are rising calls for a transformational shift.2
You are now asked to consider not just everything you can do for a patient, but also the benefits, harms, and costs associated with those choices. But where to start? We recommend that trainees integrate these tips for high-value care into their routine practice.
1. Use evidence-based resources that highlight value
A great place to begin is the “Six Things Medical Students and Trainees Should Question,” originally published in Academic Medicine and created by Choosing Wisely Canada™. Recommendations range from avoiding tests or treatments that will not change a patient’s clinical course to holding off on ordering tests solely based on what you assume your preceptor will want (see the full list in Table 1).3
Other ways to avoid low-value care include following the United States Choosing Wisely™ campaign, which has collected more than 500 specialty society recommendations. Likewise, the American College of Radiology Appropriateness Criteria are designed to assist providers with ordering the appropriate imaging tests (for a more extensive list see Table 2).
2. Express your clinical reasoning
One driver of health care expenditures that is especially prevalent in academia is the pressure to demonstrate knowledge by recommending extensive testing. While these tests may rule out obscure diagnoses, they often do not change management.
You can still demonstrate a mastery of your patients’ care by expressing your thought process overtly. For instance, “I considered secondary causes of the patient’s severe hypertension but felt it was most reasonable to first treat her pain and restart her home medications before pursuing a larger work-up. If the patient’s blood pressure remains elevated and she is hypokalemic, we could consider testing for hyperaldosteronism.” If you explain why you think a diagnosis is less likely and order tests accordingly, others will be encouraged to consider value in their own medical decision making.
3. Hone your communication skills
One of the most cited reasons for providing unnecessary care is the time required to discuss treatment plans with patients – it’s much faster to just order the test than to explain why it isn’t needed. Research, however, shows that these cost conversations take 68 seconds on average.4 Costs of Care (see Table 2) has an excellent video series that highlights how effective communication allows for shared decision making, which promotes both patient engagement and helps avoid wasteful care.
Physicians’ first instincts are often defensive when a patient asks for care we perceive as unnecessary. However, exploring what the patient hopes to gain from said test or treatment frequently reveals concern for a specific, missed diagnosis or complication. Addressing this underlying fear, rather than defending your ordering patterns, can create improved rapport and may serve to provide more reassurance than a test ever could.5
As a physician-in-training, try to observe others having these conversations and take every opportunity to practice. By focusing on this key skill set, you will increase your comfort with in-depth discussions on the value of care.
4. Get involved in a project related to high-value care
While you are developing your own practice patterns, you may be inspired to tackle areas of overuse and underuse at a more systemwide level. If your hospital does not have a committee for high-value care, perhaps a quality improvement leader can support your ideas to launch a project or participate in an ongoing initiative. Physicians-in-training have been identified as crucial to these projects’ success – your frontline insight can highlight potential problems and the nuances of workflow that are key to effective solutions.6
5. Embrace lifelong learning and reflection
The process of becoming a physician and of practicing high-value care is not a sprint but a marathon. Multiple barriers to high-value care exist, and you may feel these pressures differently at various points in your career. These include malpractice concerns, addressing patient expectations, and the desire to take action “just to be safe.”6
Interestingly, fear of malpractice does not seem to dissipate in areas where tort reform has provided stronger provider protections.7 Practitioners may also inaccurately assume a patient’s desire for additional work-up or treatment.8 Furthermore, be aware of the role of “commission bias” by which a provider regrets not doing something that could have helped a previous patient. This regret can prove to be a stronger motivator than the potential harm related to unnecessary diagnostic tests or treatments.9
While these barriers cannot be removed easily, learners and providers can practice active reflection by examining their own fears, biases, and motivations before and after they order additional testing or treatment.
As a physician-in-training, you may feel that your decisions do not have a major impact on the health care system as a whole. However, the culture shift needed to “bend the cost curve” will come from the collective efforts of individuals like you. Practicing high-value care is not just a matter of ordering fewer tests – appropriate ordering of an expensive test that expedites a diagnosis may be more cost-effective and enhance the quality of care provided. Increasing your own awareness of both necessary and unnecessary practices is a major step toward realizing system change. Your efforts to resist and reform the medical culture that propagates low value care will encourage your colleagues to follow suit.
Dr. Lacy is assistant professor and associate clerkship director at the University of New Mexico, Albuquerque, as well as division director of high-value care for the division of hospital medicine. Dr. Goetz is assistant professor at Rush University Medical Center, Chicago. They met as 2015 Copello Fellows at the National Physician Alliance. Both have been involved in numerous high-value care initiatives, curricular development, and medical education at their respective institutions.
References
1. Committee on the Learning Health Care System in America, Institute of Medicine. “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America.” Edited by Smith M, Saunders R, Stuckhardt L, and McGinnis JM. (Washington: National Academies Press, 2013). http://www.ncbi.nlm.nih.gov/books/NBK207225/.
2. Berwick DM, Hackbarth AD. Eliminating waste in US health care. JAMA. 2012;307(14):1513-6.
3. Lakhani A et al. Choosing Wisely for Medical Education: Six things medical students and trainees should question. Acad Med. 2016 Oct;91(10):1374-8.
4. Hunter WG et al. Patient-physician discussions about costs: Definitions and impact on cost conversation incidence estimates. BMC Health Serv Res. 2016;16:108.
5. van Ravesteijn H et al. The reassuring value of diagnostic tests: a systematic review. Patient Educ Couns. 2012;86(1):3-8.
6. Moriates C, Wong BM. High-value care programmes from the bottom-up… and the top-down. BMJ Qual Saf. 2016;25(11):821-3.
7. Snyder Sulmasy L, Weinberger SE. Better care is the best defense: High-value clinical practice vs. defensive medicine. Cleve Clin J Med. 2014;81(8):464-7.
8. Mulley AG, Trimble C, Elwyn G. Stop the silent misdiagnosis: Patients’ preferences matter. BMJ. 2012;345:e6572.
9. Scott IA. Cognitive challenges to minimising low value care. Intern Med J. 2017;47(9):1079-1083.
‘Culture shift’ comes from collective efforts
‘Culture shift’ comes from collective efforts
It’s Monday morning, and Mrs. Jones still has abdominal pain. Your ward team decides to order a CT. On chart review you notice she’s had three other abdominal CTs for the same indication this year. How did this happen? What should you do?
High-value care has been defined by the Institute of Medicine as “the best care for the patient, with the optimal result for the circumstances, delivered at the right price.”1 With an estimated $700 billion dollars – 30% of medical expenditures – spent on wasted care, there are rising calls for a transformational shift.2
You are now asked to consider not just everything you can do for a patient, but also the benefits, harms, and costs associated with those choices. But where to start? We recommend that trainees integrate these tips for high-value care into their routine practice.
1. Use evidence-based resources that highlight value
A great place to begin is the “Six Things Medical Students and Trainees Should Question,” originally published in Academic Medicine and created by Choosing Wisely Canada™. Recommendations range from avoiding tests or treatments that will not change a patient’s clinical course to holding off on ordering tests solely based on what you assume your preceptor will want (see the full list in Table 1).3
Other ways to avoid low-value care include following the United States Choosing Wisely™ campaign, which has collected more than 500 specialty society recommendations. Likewise, the American College of Radiology Appropriateness Criteria are designed to assist providers with ordering the appropriate imaging tests (for a more extensive list see Table 2).
2. Express your clinical reasoning
One driver of health care expenditures that is especially prevalent in academia is the pressure to demonstrate knowledge by recommending extensive testing. While these tests may rule out obscure diagnoses, they often do not change management.
You can still demonstrate a mastery of your patients’ care by expressing your thought process overtly. For instance, “I considered secondary causes of the patient’s severe hypertension but felt it was most reasonable to first treat her pain and restart her home medications before pursuing a larger work-up. If the patient’s blood pressure remains elevated and she is hypokalemic, we could consider testing for hyperaldosteronism.” If you explain why you think a diagnosis is less likely and order tests accordingly, others will be encouraged to consider value in their own medical decision making.
3. Hone your communication skills
One of the most cited reasons for providing unnecessary care is the time required to discuss treatment plans with patients – it’s much faster to just order the test than to explain why it isn’t needed. Research, however, shows that these cost conversations take 68 seconds on average.4 Costs of Care (see Table 2) has an excellent video series that highlights how effective communication allows for shared decision making, which promotes both patient engagement and helps avoid wasteful care.
Physicians’ first instincts are often defensive when a patient asks for care we perceive as unnecessary. However, exploring what the patient hopes to gain from said test or treatment frequently reveals concern for a specific, missed diagnosis or complication. Addressing this underlying fear, rather than defending your ordering patterns, can create improved rapport and may serve to provide more reassurance than a test ever could.5
As a physician-in-training, try to observe others having these conversations and take every opportunity to practice. By focusing on this key skill set, you will increase your comfort with in-depth discussions on the value of care.
4. Get involved in a project related to high-value care
While you are developing your own practice patterns, you may be inspired to tackle areas of overuse and underuse at a more systemwide level. If your hospital does not have a committee for high-value care, perhaps a quality improvement leader can support your ideas to launch a project or participate in an ongoing initiative. Physicians-in-training have been identified as crucial to these projects’ success – your frontline insight can highlight potential problems and the nuances of workflow that are key to effective solutions.6
5. Embrace lifelong learning and reflection
The process of becoming a physician and of practicing high-value care is not a sprint but a marathon. Multiple barriers to high-value care exist, and you may feel these pressures differently at various points in your career. These include malpractice concerns, addressing patient expectations, and the desire to take action “just to be safe.”6
Interestingly, fear of malpractice does not seem to dissipate in areas where tort reform has provided stronger provider protections.7 Practitioners may also inaccurately assume a patient’s desire for additional work-up or treatment.8 Furthermore, be aware of the role of “commission bias” by which a provider regrets not doing something that could have helped a previous patient. This regret can prove to be a stronger motivator than the potential harm related to unnecessary diagnostic tests or treatments.9
While these barriers cannot be removed easily, learners and providers can practice active reflection by examining their own fears, biases, and motivations before and after they order additional testing or treatment.
As a physician-in-training, you may feel that your decisions do not have a major impact on the health care system as a whole. However, the culture shift needed to “bend the cost curve” will come from the collective efforts of individuals like you. Practicing high-value care is not just a matter of ordering fewer tests – appropriate ordering of an expensive test that expedites a diagnosis may be more cost-effective and enhance the quality of care provided. Increasing your own awareness of both necessary and unnecessary practices is a major step toward realizing system change. Your efforts to resist and reform the medical culture that propagates low value care will encourage your colleagues to follow suit.
Dr. Lacy is assistant professor and associate clerkship director at the University of New Mexico, Albuquerque, as well as division director of high-value care for the division of hospital medicine. Dr. Goetz is assistant professor at Rush University Medical Center, Chicago. They met as 2015 Copello Fellows at the National Physician Alliance. Both have been involved in numerous high-value care initiatives, curricular development, and medical education at their respective institutions.
References
1. Committee on the Learning Health Care System in America, Institute of Medicine. “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America.” Edited by Smith M, Saunders R, Stuckhardt L, and McGinnis JM. (Washington: National Academies Press, 2013). http://www.ncbi.nlm.nih.gov/books/NBK207225/.
2. Berwick DM, Hackbarth AD. Eliminating waste in US health care. JAMA. 2012;307(14):1513-6.
3. Lakhani A et al. Choosing Wisely for Medical Education: Six things medical students and trainees should question. Acad Med. 2016 Oct;91(10):1374-8.
4. Hunter WG et al. Patient-physician discussions about costs: Definitions and impact on cost conversation incidence estimates. BMC Health Serv Res. 2016;16:108.
5. van Ravesteijn H et al. The reassuring value of diagnostic tests: a systematic review. Patient Educ Couns. 2012;86(1):3-8.
6. Moriates C, Wong BM. High-value care programmes from the bottom-up… and the top-down. BMJ Qual Saf. 2016;25(11):821-3.
7. Snyder Sulmasy L, Weinberger SE. Better care is the best defense: High-value clinical practice vs. defensive medicine. Cleve Clin J Med. 2014;81(8):464-7.
8. Mulley AG, Trimble C, Elwyn G. Stop the silent misdiagnosis: Patients’ preferences matter. BMJ. 2012;345:e6572.
9. Scott IA. Cognitive challenges to minimising low value care. Intern Med J. 2017;47(9):1079-1083.
It’s Monday morning, and Mrs. Jones still has abdominal pain. Your ward team decides to order a CT. On chart review you notice she’s had three other abdominal CTs for the same indication this year. How did this happen? What should you do?
High-value care has been defined by the Institute of Medicine as “the best care for the patient, with the optimal result for the circumstances, delivered at the right price.”1 With an estimated $700 billion dollars – 30% of medical expenditures – spent on wasted care, there are rising calls for a transformational shift.2
You are now asked to consider not just everything you can do for a patient, but also the benefits, harms, and costs associated with those choices. But where to start? We recommend that trainees integrate these tips for high-value care into their routine practice.
1. Use evidence-based resources that highlight value
A great place to begin is the “Six Things Medical Students and Trainees Should Question,” originally published in Academic Medicine and created by Choosing Wisely Canada™. Recommendations range from avoiding tests or treatments that will not change a patient’s clinical course to holding off on ordering tests solely based on what you assume your preceptor will want (see the full list in Table 1).3
Other ways to avoid low-value care include following the United States Choosing Wisely™ campaign, which has collected more than 500 specialty society recommendations. Likewise, the American College of Radiology Appropriateness Criteria are designed to assist providers with ordering the appropriate imaging tests (for a more extensive list see Table 2).
2. Express your clinical reasoning
One driver of health care expenditures that is especially prevalent in academia is the pressure to demonstrate knowledge by recommending extensive testing. While these tests may rule out obscure diagnoses, they often do not change management.
You can still demonstrate a mastery of your patients’ care by expressing your thought process overtly. For instance, “I considered secondary causes of the patient’s severe hypertension but felt it was most reasonable to first treat her pain and restart her home medications before pursuing a larger work-up. If the patient’s blood pressure remains elevated and she is hypokalemic, we could consider testing for hyperaldosteronism.” If you explain why you think a diagnosis is less likely and order tests accordingly, others will be encouraged to consider value in their own medical decision making.
3. Hone your communication skills
One of the most cited reasons for providing unnecessary care is the time required to discuss treatment plans with patients – it’s much faster to just order the test than to explain why it isn’t needed. Research, however, shows that these cost conversations take 68 seconds on average.4 Costs of Care (see Table 2) has an excellent video series that highlights how effective communication allows for shared decision making, which promotes both patient engagement and helps avoid wasteful care.
Physicians’ first instincts are often defensive when a patient asks for care we perceive as unnecessary. However, exploring what the patient hopes to gain from said test or treatment frequently reveals concern for a specific, missed diagnosis or complication. Addressing this underlying fear, rather than defending your ordering patterns, can create improved rapport and may serve to provide more reassurance than a test ever could.5
As a physician-in-training, try to observe others having these conversations and take every opportunity to practice. By focusing on this key skill set, you will increase your comfort with in-depth discussions on the value of care.
4. Get involved in a project related to high-value care
While you are developing your own practice patterns, you may be inspired to tackle areas of overuse and underuse at a more systemwide level. If your hospital does not have a committee for high-value care, perhaps a quality improvement leader can support your ideas to launch a project or participate in an ongoing initiative. Physicians-in-training have been identified as crucial to these projects’ success – your frontline insight can highlight potential problems and the nuances of workflow that are key to effective solutions.6
5. Embrace lifelong learning and reflection
The process of becoming a physician and of practicing high-value care is not a sprint but a marathon. Multiple barriers to high-value care exist, and you may feel these pressures differently at various points in your career. These include malpractice concerns, addressing patient expectations, and the desire to take action “just to be safe.”6
Interestingly, fear of malpractice does not seem to dissipate in areas where tort reform has provided stronger provider protections.7 Practitioners may also inaccurately assume a patient’s desire for additional work-up or treatment.8 Furthermore, be aware of the role of “commission bias” by which a provider regrets not doing something that could have helped a previous patient. This regret can prove to be a stronger motivator than the potential harm related to unnecessary diagnostic tests or treatments.9
While these barriers cannot be removed easily, learners and providers can practice active reflection by examining their own fears, biases, and motivations before and after they order additional testing or treatment.
As a physician-in-training, you may feel that your decisions do not have a major impact on the health care system as a whole. However, the culture shift needed to “bend the cost curve” will come from the collective efforts of individuals like you. Practicing high-value care is not just a matter of ordering fewer tests – appropriate ordering of an expensive test that expedites a diagnosis may be more cost-effective and enhance the quality of care provided. Increasing your own awareness of both necessary and unnecessary practices is a major step toward realizing system change. Your efforts to resist and reform the medical culture that propagates low value care will encourage your colleagues to follow suit.
Dr. Lacy is assistant professor and associate clerkship director at the University of New Mexico, Albuquerque, as well as division director of high-value care for the division of hospital medicine. Dr. Goetz is assistant professor at Rush University Medical Center, Chicago. They met as 2015 Copello Fellows at the National Physician Alliance. Both have been involved in numerous high-value care initiatives, curricular development, and medical education at their respective institutions.
References
1. Committee on the Learning Health Care System in America, Institute of Medicine. “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America.” Edited by Smith M, Saunders R, Stuckhardt L, and McGinnis JM. (Washington: National Academies Press, 2013). http://www.ncbi.nlm.nih.gov/books/NBK207225/.
2. Berwick DM, Hackbarth AD. Eliminating waste in US health care. JAMA. 2012;307(14):1513-6.
3. Lakhani A et al. Choosing Wisely for Medical Education: Six things medical students and trainees should question. Acad Med. 2016 Oct;91(10):1374-8.
4. Hunter WG et al. Patient-physician discussions about costs: Definitions and impact on cost conversation incidence estimates. BMC Health Serv Res. 2016;16:108.
5. van Ravesteijn H et al. The reassuring value of diagnostic tests: a systematic review. Patient Educ Couns. 2012;86(1):3-8.
6. Moriates C, Wong BM. High-value care programmes from the bottom-up… and the top-down. BMJ Qual Saf. 2016;25(11):821-3.
7. Snyder Sulmasy L, Weinberger SE. Better care is the best defense: High-value clinical practice vs. defensive medicine. Cleve Clin J Med. 2014;81(8):464-7.
8. Mulley AG, Trimble C, Elwyn G. Stop the silent misdiagnosis: Patients’ preferences matter. BMJ. 2012;345:e6572.
9. Scott IA. Cognitive challenges to minimising low value care. Intern Med J. 2017;47(9):1079-1083.
Question Marks Lead to Dollar Signs
An employee of a sawmill in Kentucky sustained paralyzing injuries when a large piece of milling equipment struck him in the back. His coworkers took him to the hospital in the back of a pickup truck.
At the time, some of the hospital’s nursing staff were on strike and had been replaced by temporary staff provided by US Nursing Corporation. A female nurse helped load the patient into a wheelchair for transfer into the hospital.
The patient was evaluated for a spinal injury; it was determined that he had sustained an L-3 burst fracture that impinged his spine. He was transferred to another hospital. However, due to the nature of his injuries, he is permanently paralyzed from the waist down.
The plaintiff presented a products liability claim against the machinery manufacturers, which was settled for $3.05 million. He later filed a medical malpractice complaint to include the nursing contractor and 3 individual nurses (1 from the contractor and 2 employed by the hospital). The complaint alleged that the nurses “failed to stabilize and immobilize” the patient when moving him from the pickup truck to the emergency department (ED), which worsened his injuries. A nurse employed by the contractor was identified as the nurse who had transferred him to the wheelchair.
The latter case was litigated for several years. On the eve of trial, the hospital settled for $2 million and the nursing contractor for $1.1 million. However, the hospital brought an indemnification claim against the nursing contractor to recover the $2 million settlement.
At the time of trial, there was a question regarding the identity of the nurse who had transferred the plaintiff from the pickup truck to the wheelchair. The US Nursing Corporation contract nurse contended she did not transfer the plaintiff to the wheelchair. Resolving the uncertainty, the jury concluded that the contract nurse was the nurse who had transferred the plaintiff.
VERDICT
At the conclusion of a 7-day trial, the jury awarded the plaintiff $2,823,522.
Continue to: COMMENTARY
COMMENTARY
Who doesn’t love a good mystery, right? Well, not everyone. Years ago, I was given a gift: a “host your own murder mystery party” game. I recently gave it away when I realized I was statistically more likely to be murdered than ever to host a “murder mystery party.” Love them or hate them, I think you will agree: Mysteries belong in novels or movies or board games. They have no place in your clinical practice.
In litigation, lawyers obsess over trivial details. I’ve attended enough malpractice depositions to see physicians, NPs, PAs, and nurses, with puzzled faces, answering seemingly nonsensical questions that appear to have no bearing on clinical matters. The clinicians respond half amused and half annoyed, through a litany of telephone logs, record access logs, chain-of-custody records, transfer center logs, recorded ambulance communications, time-stamped records, and recollections of who brought a specimen to the lab or what time someone was at the nurses’ station—all peripheral to practice. I understand the quizzical looks and sympathize with providers’ annoyance at having to answer seemingly inane questions. Yet these matters, collateral to practice, can take center stage in a legal case.
These issues form part of the puzzle: the who, what, where, when, why, and how of any case. For example
Who carried a specimen from the operating room (OR)? (Because it was sent from the OR, but the lab has no record of receiving it and knowing the identity of the runner is now key.)
What time did the attending call the hospital to alert the surgical team? (Because precise timing from surgeon’s knowledge to first incision is now at issue.)
Continue to: Where...
Where, specifically, was the culture taken from? (Because there were three wounds, and it turns out later two wounds were from a different source than the third.)
When did scrub tech A clock out of a surgery and scrub tech B clock in? (Because one of the surgical counts was wrong, and a surgical item was retained.)
Why did the patient leave against medical advice? (Because in the ED, he said he “needed to feed his cat.” This wasn’t recorded; the chart only states “patient left AMA.” During litigation, plaintiff claims he left because a nurse told him “it would be better to see your regular doctor.”)
How did a patient get a KFC value meal to eat in his hospital bed when strict oral intake was needed? (Because the hospital’s knowledge of the patient’s dietary intake is now at issue.)
I know—such a list of who, what, etc, can appear cutesy and cloying. Further, some of these trivial details are not recorded by clinicians, so why bring them up? I raise it because in your practice setting, you may be in a position to influence decision-making with regard to recording those minor details, which can become critically important later.
Continue to: In a medical malpractice case...
In a medical malpractice case, every tiny detail is potentially part of the puzzle. If a piece of the puzzle is missing, it becomes a mystery, and a mystery can become a problem. A plaintiff’s lawyer who sees question marks also sees dollar signs.
In this case, the presence of a “mystery nurse” likely kicked up enough dust to confuse the jury. Most clinicians are aware a malpractice plaintiff must prove 4 elements: (1) duty, (2) breach of duty, (3) causation, and (4) harm. The plaintiff must prove all elements by a preponderance of the evidence (ie, greater than 50% likely). Duty and damages are not at issue in this case; there was a clear patient relationship, and the plaintiff is clearly paralyzed. The plaintiff has the burden to prove elements (2) and (3): that there was a breach of the standard of care and that breach caused the plaintiff’s harm.
With respect to element (2), the plaintiff had the burden of showing that the act of putting him into the wheelchair was a breach of the standard of care. I think we’d all agree: The standard of care requires a registered nurse to recognize that a patient struck by a heavy object is at risk for spinal injury and spinal immobilization is required. The patient should have been removed from the vehicle with spinal immobilization techniques.
However, with respect to the causation element, the plaintiff would have been required to prove it was more probable than not (ie, 51% or greater) that the act of putting him into the wheelchair caused the paralysis. This is a stretch. The jury would have to believe it was at least 51% likely that the act of car-to-wheelchair transfer caused the injury—not the heavy mill equipment falling on him in the first place, not the efforts of his coworkers to move him from the scene, not the efforts of his coworkers to load him into the truck, not the bouncy ride in the back of a truck over to the hospital. The plaintiff was able to overcome a big causation hurdle because the identity of the nurse was not known.
The plaintiff would also generally have to show that the coworkers did not mislead the transferring nurse—that is, the statements made at the time of transfer would lead a reasonably skilled nurse to suspect spinal injury, halt transfer attempts, and see to it the patient’s spine was immobilized. Although doubtful, it is possible that in the split seconds when the car arrived at the ED, the initial communications were errant and a reasonable nurse would not have just cause to suspect spinal injury. However, we will never know. We don’t have testimony on what was said during transfer.
Continue to: So we don't know who...
So we don’t know who the nurse was. We don’t know what was said. We don’t know exactly how the plaintiff was transferred out of the vehicle. And those mysteries, to a jury, are suspicious.
IN SUMMARY
Any time a lawyer can draw a giant “?” on a whiteboard during summation, rest assured, someone is in trouble. That someone could be you. I’ve seen lots of question marks in my life; none carry a $1 million/$3 million malpractice policy. The presence of a mystery will transform a case that was defensible into one with unanswered questions. Those unanswered questions open the door to the suggestion or outright accusation of a cover-up. Do your best to document details and work within your system to encourage documentation. In short, don’t let the plaintiff host a mystery party at your expense.
An employee of a sawmill in Kentucky sustained paralyzing injuries when a large piece of milling equipment struck him in the back. His coworkers took him to the hospital in the back of a pickup truck.
At the time, some of the hospital’s nursing staff were on strike and had been replaced by temporary staff provided by US Nursing Corporation. A female nurse helped load the patient into a wheelchair for transfer into the hospital.
The patient was evaluated for a spinal injury; it was determined that he had sustained an L-3 burst fracture that impinged his spine. He was transferred to another hospital. However, due to the nature of his injuries, he is permanently paralyzed from the waist down.
The plaintiff presented a products liability claim against the machinery manufacturers, which was settled for $3.05 million. He later filed a medical malpractice complaint to include the nursing contractor and 3 individual nurses (1 from the contractor and 2 employed by the hospital). The complaint alleged that the nurses “failed to stabilize and immobilize” the patient when moving him from the pickup truck to the emergency department (ED), which worsened his injuries. A nurse employed by the contractor was identified as the nurse who had transferred him to the wheelchair.
The latter case was litigated for several years. On the eve of trial, the hospital settled for $2 million and the nursing contractor for $1.1 million. However, the hospital brought an indemnification claim against the nursing contractor to recover the $2 million settlement.
At the time of trial, there was a question regarding the identity of the nurse who had transferred the plaintiff from the pickup truck to the wheelchair. The US Nursing Corporation contract nurse contended she did not transfer the plaintiff to the wheelchair. Resolving the uncertainty, the jury concluded that the contract nurse was the nurse who had transferred the plaintiff.
VERDICT
At the conclusion of a 7-day trial, the jury awarded the plaintiff $2,823,522.
Continue to: COMMENTARY
COMMENTARY
Who doesn’t love a good mystery, right? Well, not everyone. Years ago, I was given a gift: a “host your own murder mystery party” game. I recently gave it away when I realized I was statistically more likely to be murdered than ever to host a “murder mystery party.” Love them or hate them, I think you will agree: Mysteries belong in novels or movies or board games. They have no place in your clinical practice.
In litigation, lawyers obsess over trivial details. I’ve attended enough malpractice depositions to see physicians, NPs, PAs, and nurses, with puzzled faces, answering seemingly nonsensical questions that appear to have no bearing on clinical matters. The clinicians respond half amused and half annoyed, through a litany of telephone logs, record access logs, chain-of-custody records, transfer center logs, recorded ambulance communications, time-stamped records, and recollections of who brought a specimen to the lab or what time someone was at the nurses’ station—all peripheral to practice. I understand the quizzical looks and sympathize with providers’ annoyance at having to answer seemingly inane questions. Yet these matters, collateral to practice, can take center stage in a legal case.
These issues form part of the puzzle: the who, what, where, when, why, and how of any case. For example
Who carried a specimen from the operating room (OR)? (Because it was sent from the OR, but the lab has no record of receiving it and knowing the identity of the runner is now key.)
What time did the attending call the hospital to alert the surgical team? (Because precise timing from surgeon’s knowledge to first incision is now at issue.)
Continue to: Where...
Where, specifically, was the culture taken from? (Because there were three wounds, and it turns out later two wounds were from a different source than the third.)
When did scrub tech A clock out of a surgery and scrub tech B clock in? (Because one of the surgical counts was wrong, and a surgical item was retained.)
Why did the patient leave against medical advice? (Because in the ED, he said he “needed to feed his cat.” This wasn’t recorded; the chart only states “patient left AMA.” During litigation, plaintiff claims he left because a nurse told him “it would be better to see your regular doctor.”)
How did a patient get a KFC value meal to eat in his hospital bed when strict oral intake was needed? (Because the hospital’s knowledge of the patient’s dietary intake is now at issue.)
I know—such a list of who, what, etc, can appear cutesy and cloying. Further, some of these trivial details are not recorded by clinicians, so why bring them up? I raise it because in your practice setting, you may be in a position to influence decision-making with regard to recording those minor details, which can become critically important later.
Continue to: In a medical malpractice case...
In a medical malpractice case, every tiny detail is potentially part of the puzzle. If a piece of the puzzle is missing, it becomes a mystery, and a mystery can become a problem. A plaintiff’s lawyer who sees question marks also sees dollar signs.
In this case, the presence of a “mystery nurse” likely kicked up enough dust to confuse the jury. Most clinicians are aware a malpractice plaintiff must prove 4 elements: (1) duty, (2) breach of duty, (3) causation, and (4) harm. The plaintiff must prove all elements by a preponderance of the evidence (ie, greater than 50% likely). Duty and damages are not at issue in this case; there was a clear patient relationship, and the plaintiff is clearly paralyzed. The plaintiff has the burden to prove elements (2) and (3): that there was a breach of the standard of care and that breach caused the plaintiff’s harm.
With respect to element (2), the plaintiff had the burden of showing that the act of putting him into the wheelchair was a breach of the standard of care. I think we’d all agree: The standard of care requires a registered nurse to recognize that a patient struck by a heavy object is at risk for spinal injury and spinal immobilization is required. The patient should have been removed from the vehicle with spinal immobilization techniques.
However, with respect to the causation element, the plaintiff would have been required to prove it was more probable than not (ie, 51% or greater) that the act of putting him into the wheelchair caused the paralysis. This is a stretch. The jury would have to believe it was at least 51% likely that the act of car-to-wheelchair transfer caused the injury—not the heavy mill equipment falling on him in the first place, not the efforts of his coworkers to move him from the scene, not the efforts of his coworkers to load him into the truck, not the bouncy ride in the back of a truck over to the hospital. The plaintiff was able to overcome a big causation hurdle because the identity of the nurse was not known.
The plaintiff would also generally have to show that the coworkers did not mislead the transferring nurse—that is, the statements made at the time of transfer would lead a reasonably skilled nurse to suspect spinal injury, halt transfer attempts, and see to it the patient’s spine was immobilized. Although doubtful, it is possible that in the split seconds when the car arrived at the ED, the initial communications were errant and a reasonable nurse would not have just cause to suspect spinal injury. However, we will never know. We don’t have testimony on what was said during transfer.
Continue to: So we don't know who...
So we don’t know who the nurse was. We don’t know what was said. We don’t know exactly how the plaintiff was transferred out of the vehicle. And those mysteries, to a jury, are suspicious.
IN SUMMARY
Any time a lawyer can draw a giant “?” on a whiteboard during summation, rest assured, someone is in trouble. That someone could be you. I’ve seen lots of question marks in my life; none carry a $1 million/$3 million malpractice policy. The presence of a mystery will transform a case that was defensible into one with unanswered questions. Those unanswered questions open the door to the suggestion or outright accusation of a cover-up. Do your best to document details and work within your system to encourage documentation. In short, don’t let the plaintiff host a mystery party at your expense.
An employee of a sawmill in Kentucky sustained paralyzing injuries when a large piece of milling equipment struck him in the back. His coworkers took him to the hospital in the back of a pickup truck.
At the time, some of the hospital’s nursing staff were on strike and had been replaced by temporary staff provided by US Nursing Corporation. A female nurse helped load the patient into a wheelchair for transfer into the hospital.
The patient was evaluated for a spinal injury; it was determined that he had sustained an L-3 burst fracture that impinged his spine. He was transferred to another hospital. However, due to the nature of his injuries, he is permanently paralyzed from the waist down.
The plaintiff presented a products liability claim against the machinery manufacturers, which was settled for $3.05 million. He later filed a medical malpractice complaint to include the nursing contractor and 3 individual nurses (1 from the contractor and 2 employed by the hospital). The complaint alleged that the nurses “failed to stabilize and immobilize” the patient when moving him from the pickup truck to the emergency department (ED), which worsened his injuries. A nurse employed by the contractor was identified as the nurse who had transferred him to the wheelchair.
The latter case was litigated for several years. On the eve of trial, the hospital settled for $2 million and the nursing contractor for $1.1 million. However, the hospital brought an indemnification claim against the nursing contractor to recover the $2 million settlement.
At the time of trial, there was a question regarding the identity of the nurse who had transferred the plaintiff from the pickup truck to the wheelchair. The US Nursing Corporation contract nurse contended she did not transfer the plaintiff to the wheelchair. Resolving the uncertainty, the jury concluded that the contract nurse was the nurse who had transferred the plaintiff.
VERDICT
At the conclusion of a 7-day trial, the jury awarded the plaintiff $2,823,522.
Continue to: COMMENTARY
COMMENTARY
Who doesn’t love a good mystery, right? Well, not everyone. Years ago, I was given a gift: a “host your own murder mystery party” game. I recently gave it away when I realized I was statistically more likely to be murdered than ever to host a “murder mystery party.” Love them or hate them, I think you will agree: Mysteries belong in novels or movies or board games. They have no place in your clinical practice.
In litigation, lawyers obsess over trivial details. I’ve attended enough malpractice depositions to see physicians, NPs, PAs, and nurses, with puzzled faces, answering seemingly nonsensical questions that appear to have no bearing on clinical matters. The clinicians respond half amused and half annoyed, through a litany of telephone logs, record access logs, chain-of-custody records, transfer center logs, recorded ambulance communications, time-stamped records, and recollections of who brought a specimen to the lab or what time someone was at the nurses’ station—all peripheral to practice. I understand the quizzical looks and sympathize with providers’ annoyance at having to answer seemingly inane questions. Yet these matters, collateral to practice, can take center stage in a legal case.
These issues form part of the puzzle: the who, what, where, when, why, and how of any case. For example
Who carried a specimen from the operating room (OR)? (Because it was sent from the OR, but the lab has no record of receiving it and knowing the identity of the runner is now key.)
What time did the attending call the hospital to alert the surgical team? (Because precise timing from surgeon’s knowledge to first incision is now at issue.)
Continue to: Where...
Where, specifically, was the culture taken from? (Because there were three wounds, and it turns out later two wounds were from a different source than the third.)
When did scrub tech A clock out of a surgery and scrub tech B clock in? (Because one of the surgical counts was wrong, and a surgical item was retained.)
Why did the patient leave against medical advice? (Because in the ED, he said he “needed to feed his cat.” This wasn’t recorded; the chart only states “patient left AMA.” During litigation, plaintiff claims he left because a nurse told him “it would be better to see your regular doctor.”)
How did a patient get a KFC value meal to eat in his hospital bed when strict oral intake was needed? (Because the hospital’s knowledge of the patient’s dietary intake is now at issue.)
I know—such a list of who, what, etc, can appear cutesy and cloying. Further, some of these trivial details are not recorded by clinicians, so why bring them up? I raise it because in your practice setting, you may be in a position to influence decision-making with regard to recording those minor details, which can become critically important later.
Continue to: In a medical malpractice case...
In a medical malpractice case, every tiny detail is potentially part of the puzzle. If a piece of the puzzle is missing, it becomes a mystery, and a mystery can become a problem. A plaintiff’s lawyer who sees question marks also sees dollar signs.
In this case, the presence of a “mystery nurse” likely kicked up enough dust to confuse the jury. Most clinicians are aware a malpractice plaintiff must prove 4 elements: (1) duty, (2) breach of duty, (3) causation, and (4) harm. The plaintiff must prove all elements by a preponderance of the evidence (ie, greater than 50% likely). Duty and damages are not at issue in this case; there was a clear patient relationship, and the plaintiff is clearly paralyzed. The plaintiff has the burden to prove elements (2) and (3): that there was a breach of the standard of care and that breach caused the plaintiff’s harm.
With respect to element (2), the plaintiff had the burden of showing that the act of putting him into the wheelchair was a breach of the standard of care. I think we’d all agree: The standard of care requires a registered nurse to recognize that a patient struck by a heavy object is at risk for spinal injury and spinal immobilization is required. The patient should have been removed from the vehicle with spinal immobilization techniques.
However, with respect to the causation element, the plaintiff would have been required to prove it was more probable than not (ie, 51% or greater) that the act of putting him into the wheelchair caused the paralysis. This is a stretch. The jury would have to believe it was at least 51% likely that the act of car-to-wheelchair transfer caused the injury—not the heavy mill equipment falling on him in the first place, not the efforts of his coworkers to move him from the scene, not the efforts of his coworkers to load him into the truck, not the bouncy ride in the back of a truck over to the hospital. The plaintiff was able to overcome a big causation hurdle because the identity of the nurse was not known.
The plaintiff would also generally have to show that the coworkers did not mislead the transferring nurse—that is, the statements made at the time of transfer would lead a reasonably skilled nurse to suspect spinal injury, halt transfer attempts, and see to it the patient’s spine was immobilized. Although doubtful, it is possible that in the split seconds when the car arrived at the ED, the initial communications were errant and a reasonable nurse would not have just cause to suspect spinal injury. However, we will never know. We don’t have testimony on what was said during transfer.
Continue to: So we don't know who...
So we don’t know who the nurse was. We don’t know what was said. We don’t know exactly how the plaintiff was transferred out of the vehicle. And those mysteries, to a jury, are suspicious.
IN SUMMARY
Any time a lawyer can draw a giant “?” on a whiteboard during summation, rest assured, someone is in trouble. That someone could be you. I’ve seen lots of question marks in my life; none carry a $1 million/$3 million malpractice policy. The presence of a mystery will transform a case that was defensible into one with unanswered questions. Those unanswered questions open the door to the suggestion or outright accusation of a cover-up. Do your best to document details and work within your system to encourage documentation. In short, don’t let the plaintiff host a mystery party at your expense.
Despite advances, imaging of axSpA remains an adjunctive tool
MADRID – Evidence for always using imaging in an adjunctive role to clinical findings in the diagnosis and assessment of axial spondyloarthritis (axSpA) continues to grow, two experts agreed in a scientific session at the European Congress of Rheumatology.
“Imaging has to be understood in the context of other findings. With the patient history, the physical examination, and the laboratory results, the value of imaging improves substantially. Therefore, before an image is ordered it is important to ask how likely is it that a patient has axial spondylitis,” said Floris A. van Gaalen, MD, PhD, of Leiden (Netherlands) University Medical Center.
As one of the experts who participated in the scientific session, Dr. van Gaalen focused specifically on the value of x-ray and MRI in the diagnosis of axSpA, emphasizing their limited value if interpreted without clinical context. He explained that even highly experienced radiologists are fooled, particularly at early stages of disease.
Although the quality of imaging has been increasing steadily, “there is no cookbook approach with which you can guarantee a diagnosis of spondyloarthritis. Imaging can be valuable, but there is a risk of false positives because features on imaging, such as bone marrow edema, are shared with other sources of back pain,” Dr. van Gaalen said.
Considering the importance of context, Dr. van Gaalen advised clinicians against reading the radiology report without evaluating the images themselves. He said the features on imaging make more sense when they are considered at the same time as the patient’s history, symptoms, and laboratory reports.
Order imaging relevant to treatment decisions
Assigned to discuss the value of imaging for assessing progression, Xenofon Baraliakos, MD, a rheumatologist and clinical researcher at Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany, offered the same message.
“It is important to consider all of the clinical information available, not just the features on imaging,” Dr. Baraliakos said. Often, MRI findings provide corroboration for other objective measures of disease status, but Dr. Baraliakos advised that imaging should be ordered only when it has the potential to alter therapy.
“What we can learn from imaging might be interesting, but the question to ask is whether it is useful,” Dr. Baraliakos said. Rather than incurring the costs of imaging for reassurance, Dr. Baraliakos recommended ordering these studies with specific objectives relevant to treatment decisions.
Neither Dr. van Gaalen nor Dr. Baraliakos denied the value of imaging, particularly MRI, to increase confidence in the diagnosis of axSpA or to guide therapy. Rather, their point was that imaging should not be considered a reliable stand-alone axSpA assessment strategy.
Clinical and imaging findings better then imaging alone
Data from a blinded radiology study presented during the same scientific session reinforced this conclusion. Led by Dr. Baraliakos and presented separately from his discussion about the adjunctive nature of imaging data in axSpA, the study showed that rheumatologists with access to both clinical and imaging data can detect a greater proportion of axSpA than radiologists working from imaging data alone.
In this study, 300 consecutive patients suspected of axSpA were enrolled. All had chronic back pain of more than 3 months’ duration. While highly experienced radiologists were asked to diagnose or rule out a diagnosis of axSpA on the basis of the MRI blinded to other clinical information, experienced rheumatologists evaluated the patients with access to all clinical, laboratory, and imaging data.
A diagnosis of axSpA was reached in 131 patients by the rheumatologists. The remaining 169 were determined not to have axSpA. Although the radiologists agreed on those with or without axSpA in 86.3% of cases, there were 31 cases (28.1%) in which rheumatologists diagnosed axSpA but radiologists did not.
In an analysis of which MRI features were considered critical by radiologists when there was agreement, they identified bone marrow edema in seven cases (7.2%). In 30 cases (30.9%), the radiologists considered the presence of chronic lesions to be critical to their diagnosis. In the remaining 69.9% of cases, radiologists were confident in their diagnosis only when both bone edema and chronic lesions were present.
Not surprisingly, the presence of chronic lesions and more pronounced bone marrow edema permitted both radiologists and rheumatologists to increase their confidence when discriminating between axSpA and non-axSpA patients.
“The combination of structural changes and bone marrow edema as assessed by MRI performed best in the process of diagnosing or ruling out axSpA in this real-life setting at our center,” Dr. Baraliakos said.
However, when only one or two features are considered, trade-offs of lower sensitivity for higher specificity or higher sensitivity for lower specificity occur. For example, although the specificity for a diagnosis of axSpA reached 99.4% when both bone marrow edema and ankylosis are present, the sensitivity of this finding was only 5.3%, according to data provided by Dr. Baraliakos. Conversely, the presence of sclerosis had a sensitivity of 81.7% but a specificity of only 43.2%.
One lesson from this analysis is that there is “increasing insecurity of only including bone marrow edema of the sacroiliac joint as the major criterion for diagnosing axSpA,” Dr. Baraliakos said. However, the larger point in the context of the earlier expert comments is that MRI findings should be considered important but insufficient for the evaluation of axSpA.
SOURCE: Baraliakos X et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):255-6. Abstract OPO344, doi: 10.1136/annrheumdis-2019-eular.5027
MADRID – Evidence for always using imaging in an adjunctive role to clinical findings in the diagnosis and assessment of axial spondyloarthritis (axSpA) continues to grow, two experts agreed in a scientific session at the European Congress of Rheumatology.
“Imaging has to be understood in the context of other findings. With the patient history, the physical examination, and the laboratory results, the value of imaging improves substantially. Therefore, before an image is ordered it is important to ask how likely is it that a patient has axial spondylitis,” said Floris A. van Gaalen, MD, PhD, of Leiden (Netherlands) University Medical Center.
As one of the experts who participated in the scientific session, Dr. van Gaalen focused specifically on the value of x-ray and MRI in the diagnosis of axSpA, emphasizing their limited value if interpreted without clinical context. He explained that even highly experienced radiologists are fooled, particularly at early stages of disease.
Although the quality of imaging has been increasing steadily, “there is no cookbook approach with which you can guarantee a diagnosis of spondyloarthritis. Imaging can be valuable, but there is a risk of false positives because features on imaging, such as bone marrow edema, are shared with other sources of back pain,” Dr. van Gaalen said.
Considering the importance of context, Dr. van Gaalen advised clinicians against reading the radiology report without evaluating the images themselves. He said the features on imaging make more sense when they are considered at the same time as the patient’s history, symptoms, and laboratory reports.
Order imaging relevant to treatment decisions
Assigned to discuss the value of imaging for assessing progression, Xenofon Baraliakos, MD, a rheumatologist and clinical researcher at Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany, offered the same message.
“It is important to consider all of the clinical information available, not just the features on imaging,” Dr. Baraliakos said. Often, MRI findings provide corroboration for other objective measures of disease status, but Dr. Baraliakos advised that imaging should be ordered only when it has the potential to alter therapy.
“What we can learn from imaging might be interesting, but the question to ask is whether it is useful,” Dr. Baraliakos said. Rather than incurring the costs of imaging for reassurance, Dr. Baraliakos recommended ordering these studies with specific objectives relevant to treatment decisions.
Neither Dr. van Gaalen nor Dr. Baraliakos denied the value of imaging, particularly MRI, to increase confidence in the diagnosis of axSpA or to guide therapy. Rather, their point was that imaging should not be considered a reliable stand-alone axSpA assessment strategy.
Clinical and imaging findings better then imaging alone
Data from a blinded radiology study presented during the same scientific session reinforced this conclusion. Led by Dr. Baraliakos and presented separately from his discussion about the adjunctive nature of imaging data in axSpA, the study showed that rheumatologists with access to both clinical and imaging data can detect a greater proportion of axSpA than radiologists working from imaging data alone.
In this study, 300 consecutive patients suspected of axSpA were enrolled. All had chronic back pain of more than 3 months’ duration. While highly experienced radiologists were asked to diagnose or rule out a diagnosis of axSpA on the basis of the MRI blinded to other clinical information, experienced rheumatologists evaluated the patients with access to all clinical, laboratory, and imaging data.
A diagnosis of axSpA was reached in 131 patients by the rheumatologists. The remaining 169 were determined not to have axSpA. Although the radiologists agreed on those with or without axSpA in 86.3% of cases, there were 31 cases (28.1%) in which rheumatologists diagnosed axSpA but radiologists did not.
In an analysis of which MRI features were considered critical by radiologists when there was agreement, they identified bone marrow edema in seven cases (7.2%). In 30 cases (30.9%), the radiologists considered the presence of chronic lesions to be critical to their diagnosis. In the remaining 69.9% of cases, radiologists were confident in their diagnosis only when both bone edema and chronic lesions were present.
Not surprisingly, the presence of chronic lesions and more pronounced bone marrow edema permitted both radiologists and rheumatologists to increase their confidence when discriminating between axSpA and non-axSpA patients.
“The combination of structural changes and bone marrow edema as assessed by MRI performed best in the process of diagnosing or ruling out axSpA in this real-life setting at our center,” Dr. Baraliakos said.
However, when only one or two features are considered, trade-offs of lower sensitivity for higher specificity or higher sensitivity for lower specificity occur. For example, although the specificity for a diagnosis of axSpA reached 99.4% when both bone marrow edema and ankylosis are present, the sensitivity of this finding was only 5.3%, according to data provided by Dr. Baraliakos. Conversely, the presence of sclerosis had a sensitivity of 81.7% but a specificity of only 43.2%.
One lesson from this analysis is that there is “increasing insecurity of only including bone marrow edema of the sacroiliac joint as the major criterion for diagnosing axSpA,” Dr. Baraliakos said. However, the larger point in the context of the earlier expert comments is that MRI findings should be considered important but insufficient for the evaluation of axSpA.
SOURCE: Baraliakos X et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):255-6. Abstract OPO344, doi: 10.1136/annrheumdis-2019-eular.5027
MADRID – Evidence for always using imaging in an adjunctive role to clinical findings in the diagnosis and assessment of axial spondyloarthritis (axSpA) continues to grow, two experts agreed in a scientific session at the European Congress of Rheumatology.
“Imaging has to be understood in the context of other findings. With the patient history, the physical examination, and the laboratory results, the value of imaging improves substantially. Therefore, before an image is ordered it is important to ask how likely is it that a patient has axial spondylitis,” said Floris A. van Gaalen, MD, PhD, of Leiden (Netherlands) University Medical Center.
As one of the experts who participated in the scientific session, Dr. van Gaalen focused specifically on the value of x-ray and MRI in the diagnosis of axSpA, emphasizing their limited value if interpreted without clinical context. He explained that even highly experienced radiologists are fooled, particularly at early stages of disease.
Although the quality of imaging has been increasing steadily, “there is no cookbook approach with which you can guarantee a diagnosis of spondyloarthritis. Imaging can be valuable, but there is a risk of false positives because features on imaging, such as bone marrow edema, are shared with other sources of back pain,” Dr. van Gaalen said.
Considering the importance of context, Dr. van Gaalen advised clinicians against reading the radiology report without evaluating the images themselves. He said the features on imaging make more sense when they are considered at the same time as the patient’s history, symptoms, and laboratory reports.
Order imaging relevant to treatment decisions
Assigned to discuss the value of imaging for assessing progression, Xenofon Baraliakos, MD, a rheumatologist and clinical researcher at Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany, offered the same message.
“It is important to consider all of the clinical information available, not just the features on imaging,” Dr. Baraliakos said. Often, MRI findings provide corroboration for other objective measures of disease status, but Dr. Baraliakos advised that imaging should be ordered only when it has the potential to alter therapy.
“What we can learn from imaging might be interesting, but the question to ask is whether it is useful,” Dr. Baraliakos said. Rather than incurring the costs of imaging for reassurance, Dr. Baraliakos recommended ordering these studies with specific objectives relevant to treatment decisions.
Neither Dr. van Gaalen nor Dr. Baraliakos denied the value of imaging, particularly MRI, to increase confidence in the diagnosis of axSpA or to guide therapy. Rather, their point was that imaging should not be considered a reliable stand-alone axSpA assessment strategy.
Clinical and imaging findings better then imaging alone
Data from a blinded radiology study presented during the same scientific session reinforced this conclusion. Led by Dr. Baraliakos and presented separately from his discussion about the adjunctive nature of imaging data in axSpA, the study showed that rheumatologists with access to both clinical and imaging data can detect a greater proportion of axSpA than radiologists working from imaging data alone.
In this study, 300 consecutive patients suspected of axSpA were enrolled. All had chronic back pain of more than 3 months’ duration. While highly experienced radiologists were asked to diagnose or rule out a diagnosis of axSpA on the basis of the MRI blinded to other clinical information, experienced rheumatologists evaluated the patients with access to all clinical, laboratory, and imaging data.
A diagnosis of axSpA was reached in 131 patients by the rheumatologists. The remaining 169 were determined not to have axSpA. Although the radiologists agreed on those with or without axSpA in 86.3% of cases, there were 31 cases (28.1%) in which rheumatologists diagnosed axSpA but radiologists did not.
In an analysis of which MRI features were considered critical by radiologists when there was agreement, they identified bone marrow edema in seven cases (7.2%). In 30 cases (30.9%), the radiologists considered the presence of chronic lesions to be critical to their diagnosis. In the remaining 69.9% of cases, radiologists were confident in their diagnosis only when both bone edema and chronic lesions were present.
Not surprisingly, the presence of chronic lesions and more pronounced bone marrow edema permitted both radiologists and rheumatologists to increase their confidence when discriminating between axSpA and non-axSpA patients.
“The combination of structural changes and bone marrow edema as assessed by MRI performed best in the process of diagnosing or ruling out axSpA in this real-life setting at our center,” Dr. Baraliakos said.
However, when only one or two features are considered, trade-offs of lower sensitivity for higher specificity or higher sensitivity for lower specificity occur. For example, although the specificity for a diagnosis of axSpA reached 99.4% when both bone marrow edema and ankylosis are present, the sensitivity of this finding was only 5.3%, according to data provided by Dr. Baraliakos. Conversely, the presence of sclerosis had a sensitivity of 81.7% but a specificity of only 43.2%.
One lesson from this analysis is that there is “increasing insecurity of only including bone marrow edema of the sacroiliac joint as the major criterion for diagnosing axSpA,” Dr. Baraliakos said. However, the larger point in the context of the earlier expert comments is that MRI findings should be considered important but insufficient for the evaluation of axSpA.
SOURCE: Baraliakos X et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):255-6. Abstract OPO344, doi: 10.1136/annrheumdis-2019-eular.5027
REPORTING FROM EULAR 2019 CONGRESS