Failure to find cancer earlier; patient dies: $4.69M verdict

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Failure to find cancer earlier; patient dies: $4.69M verdict

Failure to find cancer earlier; patient dies: $4.69M verdict

On July 19, a 26-year-old woman presented to the emergency department (ED) with abnormal vaginal bleeding 3 months after giving birth. She was found to have endometrial thickening and an elevated ß human chorionic gonadotropin level. An ObGyn (Dr. A) assumed that the patient was having a miscarriage and sent her home.

On July 30, when the patient returned to the ED with continued bleeding, lesions on her cervix and urethra were discovered. A second ObGyn, Dr. B, addressed the bleeding, removed the lesion, and ordered testing. On August 17, the patient saw a third ObGyn (Dr. C), who did not conduct an examination.

Days later, the patient suffered a brain hemorrhage that was suspicious for hemorrhagic metastasis. After that, stage IV choriocarcinoma was identified. Although she underwent chemotherapy, the patient died 18 months later.

ESTATE'S CLAIM: All 3 ObGyns failed to take a proper history, conduct adequate examinations, and order appropriate testing. Even at stage IV, 75% of patients with choriocarcinoma survive past 5 years. The stroke rendered chemotherapy less effective and substantially contributed to the patient's death. Failure to diagnose the cancer before the stroke allowed the disease to progress beyond the point at which the patient's life could be saved.

DEFENDANTS' DEFENSE: The ObGyns and hospital claimed that appropriate care was provided and that they were not negligent in failing to consider the diagnosis of a very rare form of cancer.

VERDICT: A $4.69 million New Jersey verdict was returned, with all 3 physicians held partially liable.

 

Hot speculum burns patient: $547,090 award

A 54-year-old woman underwent a hysterectomy performed at a government-operated hospital. After she was anesthetized and unconscious, a second-year resident took a speculum that had been placed in the sterile field by a nurse, and inserted it in the patient's vagina.

When the patient awoke from surgery, she discovered significant burns to her vaginal area, perineum, anus, and buttocks.

PATIENT'S CLAIM: The speculum had just been removed from the autoclave and was very hot. The patient incurred substantial medical bills to treat her injuries and was unable to work for several months. She sued the hospital and resident, alleging error by the nurse in placing the hot speculum in the sterile field without cooling it or advising the resident that it was still hot. The resident was blamed for using the speculum without confirming that it was hot.

DEFENDANTS' DEFENSE: The resident claimed that she reasonably relied on the nurse to not place a hot instrument in the surgical field without first cooling it. The hospital, representing the nurse, denied fault, blaming the resident for not checking the speculum.

VERDICT: A $547,090 Louisiana verdict was awarded by a judge against the resident and the hospital, but it was halved by comparative fault to $273,545.

 

Surgeon's breast exam insufficient: $375,000 verdict

After a woman in her early 40s found a lump in her left breast, she underwent a radiographic study, which a radiologist interpreted as showing a 3-mm cyst. Without performing additional tests, a general surgeon immediately scheduled her for surgery.

On May 17, the radiologist performed an ultrasound-guided needle-localized biopsy and found a nodule. The patient was immediately sent to the operating room where the surgeon performed a segmental resection of the nodule.

On May 24, the patient presented to the surgeon's office for a postoperative visit. She told the nurse that the palpable mass was still there. The nurse examined the mass, told the patient that the incision was healing nicely, and suggested follow-up in a month.

Four months later, the patient sought a second opinion. On September 15, she underwent a diagnostic mammogram, ultrasound, and biopsy. The biopsy was positive for invasive ductal carcinoma. On September 30, magnetic resonance imaging and a second biopsy further confirmed the diagnosis. On November 2, she underwent a segmental mastectomy with sentinel lymph node biopsy. The pathology report noted a 3-cm invasive ductal carcinoma with necrosis. The patient underwent chemotherapy and radiation treatment.

PATIENT'S CLAIM: She sued the general surgeon, radiologist, and surgical center, alleging that her breast cancer went undiagnosed. Prior to trial, the radiologist and surgical center were dismissed from the case.  
The surgeon failed to perform a thorough physical examination and nodal evaluation of the left breast and axilla. His substandard methods to diagnose and treat the patient's breast cancer delayed proper treatment and significantly altered the outcome.

PHYSICIAN'S CLAIM: The surgeon's treatment met the standard of care. The outcome and treatment were not significantly changed by the delay. 

VERDICT: A $375,000 Pennsylvania verdict was returned.

 

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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Failure to find cancer earlier; patient dies: $4.69M verdict

On July 19, a 26-year-old woman presented to the emergency department (ED) with abnormal vaginal bleeding 3 months after giving birth. She was found to have endometrial thickening and an elevated ß human chorionic gonadotropin level. An ObGyn (Dr. A) assumed that the patient was having a miscarriage and sent her home.

On July 30, when the patient returned to the ED with continued bleeding, lesions on her cervix and urethra were discovered. A second ObGyn, Dr. B, addressed the bleeding, removed the lesion, and ordered testing. On August 17, the patient saw a third ObGyn (Dr. C), who did not conduct an examination.

Days later, the patient suffered a brain hemorrhage that was suspicious for hemorrhagic metastasis. After that, stage IV choriocarcinoma was identified. Although she underwent chemotherapy, the patient died 18 months later.

ESTATE'S CLAIM: All 3 ObGyns failed to take a proper history, conduct adequate examinations, and order appropriate testing. Even at stage IV, 75% of patients with choriocarcinoma survive past 5 years. The stroke rendered chemotherapy less effective and substantially contributed to the patient's death. Failure to diagnose the cancer before the stroke allowed the disease to progress beyond the point at which the patient's life could be saved.

DEFENDANTS' DEFENSE: The ObGyns and hospital claimed that appropriate care was provided and that they were not negligent in failing to consider the diagnosis of a very rare form of cancer.

VERDICT: A $4.69 million New Jersey verdict was returned, with all 3 physicians held partially liable.

 

Hot speculum burns patient: $547,090 award

A 54-year-old woman underwent a hysterectomy performed at a government-operated hospital. After she was anesthetized and unconscious, a second-year resident took a speculum that had been placed in the sterile field by a nurse, and inserted it in the patient's vagina.

When the patient awoke from surgery, she discovered significant burns to her vaginal area, perineum, anus, and buttocks.

PATIENT'S CLAIM: The speculum had just been removed from the autoclave and was very hot. The patient incurred substantial medical bills to treat her injuries and was unable to work for several months. She sued the hospital and resident, alleging error by the nurse in placing the hot speculum in the sterile field without cooling it or advising the resident that it was still hot. The resident was blamed for using the speculum without confirming that it was hot.

DEFENDANTS' DEFENSE: The resident claimed that she reasonably relied on the nurse to not place a hot instrument in the surgical field without first cooling it. The hospital, representing the nurse, denied fault, blaming the resident for not checking the speculum.

VERDICT: A $547,090 Louisiana verdict was awarded by a judge against the resident and the hospital, but it was halved by comparative fault to $273,545.

 

Surgeon's breast exam insufficient: $375,000 verdict

After a woman in her early 40s found a lump in her left breast, she underwent a radiographic study, which a radiologist interpreted as showing a 3-mm cyst. Without performing additional tests, a general surgeon immediately scheduled her for surgery.

On May 17, the radiologist performed an ultrasound-guided needle-localized biopsy and found a nodule. The patient was immediately sent to the operating room where the surgeon performed a segmental resection of the nodule.

On May 24, the patient presented to the surgeon's office for a postoperative visit. She told the nurse that the palpable mass was still there. The nurse examined the mass, told the patient that the incision was healing nicely, and suggested follow-up in a month.

Four months later, the patient sought a second opinion. On September 15, she underwent a diagnostic mammogram, ultrasound, and biopsy. The biopsy was positive for invasive ductal carcinoma. On September 30, magnetic resonance imaging and a second biopsy further confirmed the diagnosis. On November 2, she underwent a segmental mastectomy with sentinel lymph node biopsy. The pathology report noted a 3-cm invasive ductal carcinoma with necrosis. The patient underwent chemotherapy and radiation treatment.

PATIENT'S CLAIM: She sued the general surgeon, radiologist, and surgical center, alleging that her breast cancer went undiagnosed. Prior to trial, the radiologist and surgical center were dismissed from the case.  
The surgeon failed to perform a thorough physical examination and nodal evaluation of the left breast and axilla. His substandard methods to diagnose and treat the patient's breast cancer delayed proper treatment and significantly altered the outcome.

PHYSICIAN'S CLAIM: The surgeon's treatment met the standard of care. The outcome and treatment were not significantly changed by the delay. 

VERDICT: A $375,000 Pennsylvania verdict was returned.

 

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Failure to find cancer earlier; patient dies: $4.69M verdict

On July 19, a 26-year-old woman presented to the emergency department (ED) with abnormal vaginal bleeding 3 months after giving birth. She was found to have endometrial thickening and an elevated ß human chorionic gonadotropin level. An ObGyn (Dr. A) assumed that the patient was having a miscarriage and sent her home.

On July 30, when the patient returned to the ED with continued bleeding, lesions on her cervix and urethra were discovered. A second ObGyn, Dr. B, addressed the bleeding, removed the lesion, and ordered testing. On August 17, the patient saw a third ObGyn (Dr. C), who did not conduct an examination.

Days later, the patient suffered a brain hemorrhage that was suspicious for hemorrhagic metastasis. After that, stage IV choriocarcinoma was identified. Although she underwent chemotherapy, the patient died 18 months later.

ESTATE'S CLAIM: All 3 ObGyns failed to take a proper history, conduct adequate examinations, and order appropriate testing. Even at stage IV, 75% of patients with choriocarcinoma survive past 5 years. The stroke rendered chemotherapy less effective and substantially contributed to the patient's death. Failure to diagnose the cancer before the stroke allowed the disease to progress beyond the point at which the patient's life could be saved.

DEFENDANTS' DEFENSE: The ObGyns and hospital claimed that appropriate care was provided and that they were not negligent in failing to consider the diagnosis of a very rare form of cancer.

VERDICT: A $4.69 million New Jersey verdict was returned, with all 3 physicians held partially liable.

 

Hot speculum burns patient: $547,090 award

A 54-year-old woman underwent a hysterectomy performed at a government-operated hospital. After she was anesthetized and unconscious, a second-year resident took a speculum that had been placed in the sterile field by a nurse, and inserted it in the patient's vagina.

When the patient awoke from surgery, she discovered significant burns to her vaginal area, perineum, anus, and buttocks.

PATIENT'S CLAIM: The speculum had just been removed from the autoclave and was very hot. The patient incurred substantial medical bills to treat her injuries and was unable to work for several months. She sued the hospital and resident, alleging error by the nurse in placing the hot speculum in the sterile field without cooling it or advising the resident that it was still hot. The resident was blamed for using the speculum without confirming that it was hot.

DEFENDANTS' DEFENSE: The resident claimed that she reasonably relied on the nurse to not place a hot instrument in the surgical field without first cooling it. The hospital, representing the nurse, denied fault, blaming the resident for not checking the speculum.

VERDICT: A $547,090 Louisiana verdict was awarded by a judge against the resident and the hospital, but it was halved by comparative fault to $273,545.

 

Surgeon's breast exam insufficient: $375,000 verdict

After a woman in her early 40s found a lump in her left breast, she underwent a radiographic study, which a radiologist interpreted as showing a 3-mm cyst. Without performing additional tests, a general surgeon immediately scheduled her for surgery.

On May 17, the radiologist performed an ultrasound-guided needle-localized biopsy and found a nodule. The patient was immediately sent to the operating room where the surgeon performed a segmental resection of the nodule.

On May 24, the patient presented to the surgeon's office for a postoperative visit. She told the nurse that the palpable mass was still there. The nurse examined the mass, told the patient that the incision was healing nicely, and suggested follow-up in a month.

Four months later, the patient sought a second opinion. On September 15, she underwent a diagnostic mammogram, ultrasound, and biopsy. The biopsy was positive for invasive ductal carcinoma. On September 30, magnetic resonance imaging and a second biopsy further confirmed the diagnosis. On November 2, she underwent a segmental mastectomy with sentinel lymph node biopsy. The pathology report noted a 3-cm invasive ductal carcinoma with necrosis. The patient underwent chemotherapy and radiation treatment.

PATIENT'S CLAIM: She sued the general surgeon, radiologist, and surgical center, alleging that her breast cancer went undiagnosed. Prior to trial, the radiologist and surgical center were dismissed from the case.  
The surgeon failed to perform a thorough physical examination and nodal evaluation of the left breast and axilla. His substandard methods to diagnose and treat the patient's breast cancer delayed proper treatment and significantly altered the outcome.

PHYSICIAN'S CLAIM: The surgeon's treatment met the standard of care. The outcome and treatment were not significantly changed by the delay. 

VERDICT: A $375,000 Pennsylvania verdict was returned.

 

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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Checkpoint inhibition less toxic than antiangiogenic therapy in NSCLC

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Checkpoint blockade is associated with reduced toxicity when compared with antiangiogenic therapies for the treatment of advanced non–small-cell lung cancer, a systematic review and meta-analysis suggests.

In 16,810 patients from 37 trials included in the analysis, first-line treatment with nivolumab or pembrolizumab, compared with first-line sorafenib plus platinum doublets, for example, was associated with less combined direct and indirect toxicity (odds ratios, 0.08 and 0.12, respectively), Chin-Chuan Hung, MD, and her colleagues reported in a poster at the annual conference of the National Comprehensive Cancer Network.

For subsequent therapy, nivolumab showed lower risk than most antiangiogenic therapies, particularly combination ramucirumab and docetaxel (OR, 0.06), said Dr. Hung of China Medical University Hospital in Taichung, Taiwan.



The findings are notable because tolerability is an essential selection criterion for patients with advanced stage disease, and while checkpoint inhibitors – including nivolumab, pembrolizumab, and atezolizumab – and antiangiogenic agents – including bevacizumab, ramucirumab, and nintedanib – have become the treatments of choice, direct comparisons with respect to tolerability are lacking, she noted.

The investigators performed a systematic review using Bayesian-model network meta-analysis of studies conducted through July 2017 comparing first-line and subsequent regimens containing chemotherapy, antiangiogenic therapy, and/or immune checkpoint inhibitors. Chemotherapy agents studied included cisplatin, carboplatin, oxaliplatin, gemcitabine, paclitaxel, docetaxel, and pemetrexed; antiangiogenic agents included bevacizumab, aflibercept, ramucirumab, nintedanib, axitinib, sorafenib, vandetanib, and sunitinib; and immune checkpoint inhibitors included ipilimumab, pembrolizumab, nivolumab, and atezolizumab.

Direct and indirect data for all grade 3-5 adverse events were combined using random-effects network meta-analysis.

“The results indicated that [checkpoint] inhibitors can be preferred choices for less toxicity to treat advanced stage NSCLC compared with antiangiogenic therapies in first-line and subsequent settings,” Dr. Hung and her associates concluded.

 

 


This study was supported by the China Medical University Beigang Hospital.

SOURCE: Hsu C et al. NCCN poster 13

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Checkpoint blockade is associated with reduced toxicity when compared with antiangiogenic therapies for the treatment of advanced non–small-cell lung cancer, a systematic review and meta-analysis suggests.

In 16,810 patients from 37 trials included in the analysis, first-line treatment with nivolumab or pembrolizumab, compared with first-line sorafenib plus platinum doublets, for example, was associated with less combined direct and indirect toxicity (odds ratios, 0.08 and 0.12, respectively), Chin-Chuan Hung, MD, and her colleagues reported in a poster at the annual conference of the National Comprehensive Cancer Network.

For subsequent therapy, nivolumab showed lower risk than most antiangiogenic therapies, particularly combination ramucirumab and docetaxel (OR, 0.06), said Dr. Hung of China Medical University Hospital in Taichung, Taiwan.



The findings are notable because tolerability is an essential selection criterion for patients with advanced stage disease, and while checkpoint inhibitors – including nivolumab, pembrolizumab, and atezolizumab – and antiangiogenic agents – including bevacizumab, ramucirumab, and nintedanib – have become the treatments of choice, direct comparisons with respect to tolerability are lacking, she noted.

The investigators performed a systematic review using Bayesian-model network meta-analysis of studies conducted through July 2017 comparing first-line and subsequent regimens containing chemotherapy, antiangiogenic therapy, and/or immune checkpoint inhibitors. Chemotherapy agents studied included cisplatin, carboplatin, oxaliplatin, gemcitabine, paclitaxel, docetaxel, and pemetrexed; antiangiogenic agents included bevacizumab, aflibercept, ramucirumab, nintedanib, axitinib, sorafenib, vandetanib, and sunitinib; and immune checkpoint inhibitors included ipilimumab, pembrolizumab, nivolumab, and atezolizumab.

Direct and indirect data for all grade 3-5 adverse events were combined using random-effects network meta-analysis.

“The results indicated that [checkpoint] inhibitors can be preferred choices for less toxicity to treat advanced stage NSCLC compared with antiangiogenic therapies in first-line and subsequent settings,” Dr. Hung and her associates concluded.

 

 


This study was supported by the China Medical University Beigang Hospital.

SOURCE: Hsu C et al. NCCN poster 13

 

Checkpoint blockade is associated with reduced toxicity when compared with antiangiogenic therapies for the treatment of advanced non–small-cell lung cancer, a systematic review and meta-analysis suggests.

In 16,810 patients from 37 trials included in the analysis, first-line treatment with nivolumab or pembrolizumab, compared with first-line sorafenib plus platinum doublets, for example, was associated with less combined direct and indirect toxicity (odds ratios, 0.08 and 0.12, respectively), Chin-Chuan Hung, MD, and her colleagues reported in a poster at the annual conference of the National Comprehensive Cancer Network.

For subsequent therapy, nivolumab showed lower risk than most antiangiogenic therapies, particularly combination ramucirumab and docetaxel (OR, 0.06), said Dr. Hung of China Medical University Hospital in Taichung, Taiwan.



The findings are notable because tolerability is an essential selection criterion for patients with advanced stage disease, and while checkpoint inhibitors – including nivolumab, pembrolizumab, and atezolizumab – and antiangiogenic agents – including bevacizumab, ramucirumab, and nintedanib – have become the treatments of choice, direct comparisons with respect to tolerability are lacking, she noted.

The investigators performed a systematic review using Bayesian-model network meta-analysis of studies conducted through July 2017 comparing first-line and subsequent regimens containing chemotherapy, antiangiogenic therapy, and/or immune checkpoint inhibitors. Chemotherapy agents studied included cisplatin, carboplatin, oxaliplatin, gemcitabine, paclitaxel, docetaxel, and pemetrexed; antiangiogenic agents included bevacizumab, aflibercept, ramucirumab, nintedanib, axitinib, sorafenib, vandetanib, and sunitinib; and immune checkpoint inhibitors included ipilimumab, pembrolizumab, nivolumab, and atezolizumab.

Direct and indirect data for all grade 3-5 adverse events were combined using random-effects network meta-analysis.

“The results indicated that [checkpoint] inhibitors can be preferred choices for less toxicity to treat advanced stage NSCLC compared with antiangiogenic therapies in first-line and subsequent settings,” Dr. Hung and her associates concluded.

 

 


This study was supported by the China Medical University Beigang Hospital.

SOURCE: Hsu C et al. NCCN poster 13

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REPORTING FROM THE NCCN ANNUAL CONFERENCE

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Key clinical point: Checkpoint blockade appears less toxic than antiangiogenic therapies in advanced NSCLC

Major finding: Less toxicity was seen with first-line nivolumab or pembrolizumab vs. sorafenib + platinum doublets (odds ratios, 0.08 and 0.12, respectively).

Study details: A systematic review and meta-analysis of 37 trials involving 16,810 patients.

Disclosures: The study was supported by the China Medical University Beigang Hospital.

Source: Hsu C et al. NCCN poster 13.

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Obesity in adults continues to rise

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Obesity and severe obesity rose significantly in adults but not in children from 2007 to 2016, according to data from the National Health and Nutrition Examination Survey.

The age-standardized prevalence of obesity – defined as a body mass index of 30 or more – among adults aged 20 years and over increased from 33.7% for the 2-year period of 2007-2008 to 39.6% in 2015-2016, while the prevalence of severe obesity – defined as a body mass index of 40 kg/m2 or more – went from 5.7% to 7.7% over that same period, Craig M. Hales, MD, and his associates at the Centers for Disease Control and Prevention in Hyattsville, Md., and Atlanta said in a research letter published in JAMA.

The prevalence of obesity in children aged 2-19 years – defined as BMI at or above the sex-specific 95th percentile – increased, but not significantly, from 16.8% in 2007-2008 to 18.5% in 2015-2016, with most of that increase coming in the last 2 years. Severe obesity – BMI at or above 120% of the sex-specific 95th percentile – rose from 4.9% to 5.6% over those 10 years, but the last 2-year period saw the rate drop from 6% in 2013-2014, the investigators reported.

For the most recent reporting period, boys were more likely than girls to be obese (19.1% vs. 17.8%) and severely obese (6.3% vs. 4.9%), and both obesity and severe obesity were more common with increasing age. Obesity prevalence went from 13.9% in those aged 2-5 years to 20.6% in 12- to 19-year-olds, and severe obesity was 1.8% in the youngest group and 7.7% in the oldest, with the middle-age group (6-11 years) in the middle in both categories, they said

Among the adults, obesity was more common in women than men (41.1% vs. 37.9%) for 2015-2016, as was severe obesity (9.7% vs. 5.6%). Obesity and severe obesity were both highest in those aged 40-59 years, but obesity prevalence was lowest in the younger group (20-39 years) and severe obesity was least common in the older group (60 years and older), Dr. Hales and his associates said.

The analysis involved 16,875 children and 27,449 adults over the 10-year period. The investigators did not report any conflicts of interest.

AGA patient education materials can help your patients better understand how to manage and discuss obesity, including lifestyle, pharmacological and endoscopic treatment options. Learn more at www.gastro.org/patientInfo/topic/obesity.

SOURCE: Hales CM et al. JAMA 2018 Mar 23. doi: 10.1001/jama.2018.3060.

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Obesity and severe obesity rose significantly in adults but not in children from 2007 to 2016, according to data from the National Health and Nutrition Examination Survey.

The age-standardized prevalence of obesity – defined as a body mass index of 30 or more – among adults aged 20 years and over increased from 33.7% for the 2-year period of 2007-2008 to 39.6% in 2015-2016, while the prevalence of severe obesity – defined as a body mass index of 40 kg/m2 or more – went from 5.7% to 7.7% over that same period, Craig M. Hales, MD, and his associates at the Centers for Disease Control and Prevention in Hyattsville, Md., and Atlanta said in a research letter published in JAMA.

The prevalence of obesity in children aged 2-19 years – defined as BMI at or above the sex-specific 95th percentile – increased, but not significantly, from 16.8% in 2007-2008 to 18.5% in 2015-2016, with most of that increase coming in the last 2 years. Severe obesity – BMI at or above 120% of the sex-specific 95th percentile – rose from 4.9% to 5.6% over those 10 years, but the last 2-year period saw the rate drop from 6% in 2013-2014, the investigators reported.

For the most recent reporting period, boys were more likely than girls to be obese (19.1% vs. 17.8%) and severely obese (6.3% vs. 4.9%), and both obesity and severe obesity were more common with increasing age. Obesity prevalence went from 13.9% in those aged 2-5 years to 20.6% in 12- to 19-year-olds, and severe obesity was 1.8% in the youngest group and 7.7% in the oldest, with the middle-age group (6-11 years) in the middle in both categories, they said

Among the adults, obesity was more common in women than men (41.1% vs. 37.9%) for 2015-2016, as was severe obesity (9.7% vs. 5.6%). Obesity and severe obesity were both highest in those aged 40-59 years, but obesity prevalence was lowest in the younger group (20-39 years) and severe obesity was least common in the older group (60 years and older), Dr. Hales and his associates said.

The analysis involved 16,875 children and 27,449 adults over the 10-year period. The investigators did not report any conflicts of interest.

AGA patient education materials can help your patients better understand how to manage and discuss obesity, including lifestyle, pharmacological and endoscopic treatment options. Learn more at www.gastro.org/patientInfo/topic/obesity.

SOURCE: Hales CM et al. JAMA 2018 Mar 23. doi: 10.1001/jama.2018.3060.

 

Obesity and severe obesity rose significantly in adults but not in children from 2007 to 2016, according to data from the National Health and Nutrition Examination Survey.

The age-standardized prevalence of obesity – defined as a body mass index of 30 or more – among adults aged 20 years and over increased from 33.7% for the 2-year period of 2007-2008 to 39.6% in 2015-2016, while the prevalence of severe obesity – defined as a body mass index of 40 kg/m2 or more – went from 5.7% to 7.7% over that same period, Craig M. Hales, MD, and his associates at the Centers for Disease Control and Prevention in Hyattsville, Md., and Atlanta said in a research letter published in JAMA.

The prevalence of obesity in children aged 2-19 years – defined as BMI at or above the sex-specific 95th percentile – increased, but not significantly, from 16.8% in 2007-2008 to 18.5% in 2015-2016, with most of that increase coming in the last 2 years. Severe obesity – BMI at or above 120% of the sex-specific 95th percentile – rose from 4.9% to 5.6% over those 10 years, but the last 2-year period saw the rate drop from 6% in 2013-2014, the investigators reported.

For the most recent reporting period, boys were more likely than girls to be obese (19.1% vs. 17.8%) and severely obese (6.3% vs. 4.9%), and both obesity and severe obesity were more common with increasing age. Obesity prevalence went from 13.9% in those aged 2-5 years to 20.6% in 12- to 19-year-olds, and severe obesity was 1.8% in the youngest group and 7.7% in the oldest, with the middle-age group (6-11 years) in the middle in both categories, they said

Among the adults, obesity was more common in women than men (41.1% vs. 37.9%) for 2015-2016, as was severe obesity (9.7% vs. 5.6%). Obesity and severe obesity were both highest in those aged 40-59 years, but obesity prevalence was lowest in the younger group (20-39 years) and severe obesity was least common in the older group (60 years and older), Dr. Hales and his associates said.

The analysis involved 16,875 children and 27,449 adults over the 10-year period. The investigators did not report any conflicts of interest.

AGA patient education materials can help your patients better understand how to manage and discuss obesity, including lifestyle, pharmacological and endoscopic treatment options. Learn more at www.gastro.org/patientInfo/topic/obesity.

SOURCE: Hales CM et al. JAMA 2018 Mar 23. doi: 10.1001/jama.2018.3060.

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Greater Occipital Nerve Block Proves Effective

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Greater Occipital Nerve Block Proves Effective
J Am Board Fam Med; 2018 Mar-Apr; Allen, et al

Greater occipital nerve (GON) block seems to be an effective option for acute management of migraine headache, with promising reductions in pain scores, a recent study found. This retrospective cohort study was undertaken between January 2009 and August 2014 and included patients who underwent at least 1 GON block and attended at least 1 follow-up appointment. Change in the 11-point numeric pain rating scale (NPRS) was used to assess the response to GON block. A total of 562 patients met inclusion criteria; 423 were women (75%); mean age was 58.6 ± 16.7 years. Response was defined as “minimal” (less than 30% NPRS point reduction), “moderate” (31% to 50% NPRS point reduction), or “significant” ( greater than 50% NPRS point reduction). Researchers found:

  • Of total patients, 459 (82%) rated their response to GON block as moderate or significant.
  • No statistically significant relationship existed between previous treatment regimens and response to GON block.
  • GON block was equally effective across the different age and sex groups.

Greater occipital nerve block for acute treatment of migraine headache: A large retrospective cohort study. J Am Board Fam Med. 2018;31(2):211-218. doi:10.3122/jabfm.2018.02.170188.

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J Am Board Fam Med; 2018 Mar-Apr; Allen, et al
J Am Board Fam Med; 2018 Mar-Apr; Allen, et al

Greater occipital nerve (GON) block seems to be an effective option for acute management of migraine headache, with promising reductions in pain scores, a recent study found. This retrospective cohort study was undertaken between January 2009 and August 2014 and included patients who underwent at least 1 GON block and attended at least 1 follow-up appointment. Change in the 11-point numeric pain rating scale (NPRS) was used to assess the response to GON block. A total of 562 patients met inclusion criteria; 423 were women (75%); mean age was 58.6 ± 16.7 years. Response was defined as “minimal” (less than 30% NPRS point reduction), “moderate” (31% to 50% NPRS point reduction), or “significant” ( greater than 50% NPRS point reduction). Researchers found:

  • Of total patients, 459 (82%) rated their response to GON block as moderate or significant.
  • No statistically significant relationship existed between previous treatment regimens and response to GON block.
  • GON block was equally effective across the different age and sex groups.

Greater occipital nerve block for acute treatment of migraine headache: A large retrospective cohort study. J Am Board Fam Med. 2018;31(2):211-218. doi:10.3122/jabfm.2018.02.170188.

Greater occipital nerve (GON) block seems to be an effective option for acute management of migraine headache, with promising reductions in pain scores, a recent study found. This retrospective cohort study was undertaken between January 2009 and August 2014 and included patients who underwent at least 1 GON block and attended at least 1 follow-up appointment. Change in the 11-point numeric pain rating scale (NPRS) was used to assess the response to GON block. A total of 562 patients met inclusion criteria; 423 were women (75%); mean age was 58.6 ± 16.7 years. Response was defined as “minimal” (less than 30% NPRS point reduction), “moderate” (31% to 50% NPRS point reduction), or “significant” ( greater than 50% NPRS point reduction). Researchers found:

  • Of total patients, 459 (82%) rated their response to GON block as moderate or significant.
  • No statistically significant relationship existed between previous treatment regimens and response to GON block.
  • GON block was equally effective across the different age and sex groups.

Greater occipital nerve block for acute treatment of migraine headache: A large retrospective cohort study. J Am Board Fam Med. 2018;31(2):211-218. doi:10.3122/jabfm.2018.02.170188.

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Brain Diffusion Abnormalities in Children Examined

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AJNR Am J Neuroradiol; ePub 2018 Mar 15; Santoro, et al

A recent study identifies early cerebral diffusion changes in children with tension-type and migraine-type headaches compared with controls. The hypothesized mechanisms of nociception in migraine-type and tension-type headaches may explain the findings as a precursor to structural changes seen in adult patients with chronic headache. Patients evaluated for tension-type or migraine-type headache without aura from May 2014 to July 2016 in a single center were retrospectively reviewed. Thirty-two patients with tension-type headache and 23 with migraine-type headache at an average of 4 months after diagnosis were enrolled. All patients underwent diffusion weighted imaging at 3T before the start of pharmacotherapy. Researchers found:

  • There were no significant differences in regional brain volumes between the groups.
  • Patients with tension-type and migraine-type headaches showed significantly increased apparent diffusion coefficient (ADC) in the hippocampus and brain stem compared with controls.
  • Additionally, only patients with migraine-type headache showed significantly increased ADC in the thalamus and a trend toward increased ADC in the amygdala compared with controls.

Brain diffusion abnormalities in children with tension-type and migraine-type headaches. [Published online ahead of print March 15, 2018]. AJNR Am J Neuroradiol. doi:10.3174/ajnr.A5582.

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AJNR Am J Neuroradiol; ePub 2018 Mar 15; Santoro, et al
AJNR Am J Neuroradiol; ePub 2018 Mar 15; Santoro, et al

A recent study identifies early cerebral diffusion changes in children with tension-type and migraine-type headaches compared with controls. The hypothesized mechanisms of nociception in migraine-type and tension-type headaches may explain the findings as a precursor to structural changes seen in adult patients with chronic headache. Patients evaluated for tension-type or migraine-type headache without aura from May 2014 to July 2016 in a single center were retrospectively reviewed. Thirty-two patients with tension-type headache and 23 with migraine-type headache at an average of 4 months after diagnosis were enrolled. All patients underwent diffusion weighted imaging at 3T before the start of pharmacotherapy. Researchers found:

  • There were no significant differences in regional brain volumes between the groups.
  • Patients with tension-type and migraine-type headaches showed significantly increased apparent diffusion coefficient (ADC) in the hippocampus and brain stem compared with controls.
  • Additionally, only patients with migraine-type headache showed significantly increased ADC in the thalamus and a trend toward increased ADC in the amygdala compared with controls.

Brain diffusion abnormalities in children with tension-type and migraine-type headaches. [Published online ahead of print March 15, 2018]. AJNR Am J Neuroradiol. doi:10.3174/ajnr.A5582.

A recent study identifies early cerebral diffusion changes in children with tension-type and migraine-type headaches compared with controls. The hypothesized mechanisms of nociception in migraine-type and tension-type headaches may explain the findings as a precursor to structural changes seen in adult patients with chronic headache. Patients evaluated for tension-type or migraine-type headache without aura from May 2014 to July 2016 in a single center were retrospectively reviewed. Thirty-two patients with tension-type headache and 23 with migraine-type headache at an average of 4 months after diagnosis were enrolled. All patients underwent diffusion weighted imaging at 3T before the start of pharmacotherapy. Researchers found:

  • There were no significant differences in regional brain volumes between the groups.
  • Patients with tension-type and migraine-type headaches showed significantly increased apparent diffusion coefficient (ADC) in the hippocampus and brain stem compared with controls.
  • Additionally, only patients with migraine-type headache showed significantly increased ADC in the thalamus and a trend toward increased ADC in the amygdala compared with controls.

Brain diffusion abnormalities in children with tension-type and migraine-type headaches. [Published online ahead of print March 15, 2018]. AJNR Am J Neuroradiol. doi:10.3174/ajnr.A5582.

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Migraine Linked with Otolaryngologic Symptoms

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Otolaryngol Head Neck Surg; ePub 2018 Mar 20; Schulz, et al

Migraine disease has a higher prevalence in an otolaryngologic cohort than in the general population, according to a recent study, presenting with a high rate of sinonasal and otologic symptoms that may be due to or exacerbated by migraines. In a cross-sectional study utilizing the CHEER (Creating Healthcare Excellence through Education and Research) network, patients were recruited in 14 CHEER sites between June 2015 and March 2017. Those included were aged 18 years or older and had been seen for any concern that was not head and neck cancer. Patients with any history of brain abnormality or headaches that began within 2 weeks of a medical illness, trauma, or head injury were excluded. If they screened positive on the Migraine Assessment Tool (MAT+), the subjects also filled out questionnaires for sinonasal, otologic, and migraine-specific symptoms. Researchers found:

  • Of 1458 patients screened, 235 (16.1%) screened positive for migraine (MAT+), which is higher than the general population (13%).
  • The MAT+ group was significantly younger (47.2 vs 55.6 years of age) and predominantly women (80.0% vs 55.9%).

Patterns of migraine disease in otolaryngology: A CHEER network study. [Published online ahead of print March 20, 2018]. Otolaryngol Head Neck Surg. doi:10.1177/0194599818764387.

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Otolaryngol Head Neck Surg; ePub 2018 Mar 20; Schulz, et al
Otolaryngol Head Neck Surg; ePub 2018 Mar 20; Schulz, et al

Migraine disease has a higher prevalence in an otolaryngologic cohort than in the general population, according to a recent study, presenting with a high rate of sinonasal and otologic symptoms that may be due to or exacerbated by migraines. In a cross-sectional study utilizing the CHEER (Creating Healthcare Excellence through Education and Research) network, patients were recruited in 14 CHEER sites between June 2015 and March 2017. Those included were aged 18 years or older and had been seen for any concern that was not head and neck cancer. Patients with any history of brain abnormality or headaches that began within 2 weeks of a medical illness, trauma, or head injury were excluded. If they screened positive on the Migraine Assessment Tool (MAT+), the subjects also filled out questionnaires for sinonasal, otologic, and migraine-specific symptoms. Researchers found:

  • Of 1458 patients screened, 235 (16.1%) screened positive for migraine (MAT+), which is higher than the general population (13%).
  • The MAT+ group was significantly younger (47.2 vs 55.6 years of age) and predominantly women (80.0% vs 55.9%).

Patterns of migraine disease in otolaryngology: A CHEER network study. [Published online ahead of print March 20, 2018]. Otolaryngol Head Neck Surg. doi:10.1177/0194599818764387.

Migraine disease has a higher prevalence in an otolaryngologic cohort than in the general population, according to a recent study, presenting with a high rate of sinonasal and otologic symptoms that may be due to or exacerbated by migraines. In a cross-sectional study utilizing the CHEER (Creating Healthcare Excellence through Education and Research) network, patients were recruited in 14 CHEER sites between June 2015 and March 2017. Those included were aged 18 years or older and had been seen for any concern that was not head and neck cancer. Patients with any history of brain abnormality or headaches that began within 2 weeks of a medical illness, trauma, or head injury were excluded. If they screened positive on the Migraine Assessment Tool (MAT+), the subjects also filled out questionnaires for sinonasal, otologic, and migraine-specific symptoms. Researchers found:

  • Of 1458 patients screened, 235 (16.1%) screened positive for migraine (MAT+), which is higher than the general population (13%).
  • The MAT+ group was significantly younger (47.2 vs 55.6 years of age) and predominantly women (80.0% vs 55.9%).

Patterns of migraine disease in otolaryngology: A CHEER network study. [Published online ahead of print March 20, 2018]. Otolaryngol Head Neck Surg. doi:10.1177/0194599818764387.

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It costs what?! How we can educate residents and students on how much things cost

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Why are you ordering a CBC on the patient when her white blood cell count, hemoglobin, and platelets have been stable for the past 3 days?” sternly inquired the attending gynecologic oncologist. “Don’t order tests without any clinical indication. If she is infected or bleeding, there will be signs and thus an indication to order a CBC. The physical exam is your test.” There was an authoritative pause before he invoked the “value-based care” maxim.

For many residents who graduated in the past decade, education in value-based care and alternative payment models (APMs) was cobbled together from experience, demonstrated by attendings who labeled it as such, and from rare didactic education classroom sessions and inpatient environments.

In today’s health care environment, professional survival requires the ability to successfully deliver high-value care to patients. Attendings often illustrate and champion how to do this by using patient care to highlight the definition: Value = Quality ÷ Cost.

For residency education programs to create the ObGyns of the future, they must teach trainees what they will be evaluated on and held accountable for.1 Today’s clinicians will have to take responsibility for reigning in health care costs from the fee-for-service era, which in the United States have snowballed into one of the unhealthiest cost-to-outcomes ratios worldwide. Residents will be required to understand not only value but also areas in which they can influence the cost of care and how their outcome metrics are valued.

Modifiable factors in value-based care

As mentioned, value is defined by the equation, Value = Quality ÷ Cost. The granularity of these terms helps clarify the depth and the multitude of levels that clinicians can modify and influence to achieve the highest value.

Quality, as defined by the National Academy of Medicine, includes2:

  • effectiveness: providing care processes and achieving outcomes as supported by scientific evidence
  • efficiency: maximizing the quality of a comparable unit of health care delivered or unit of health benefit achieved for a given unit of health care resources used
  • equity: providing health care of equal quality to those who may differ in personal characteristics other than their clinical condition or preferences for care
  • patient-centeredness: meeting patient needs and preferences and providing education and support
  • safety: actual or potential bodily harm
  • timeliness: obtaining needed care while minimizing delays.

From electronic health records, which were mandated in the Patient Protection and Affordable Care Act of 2010, offices, hospitals, and medical systems have gained robust databases of mineable information. Even data abstraction from paper records has been made easier, allowing better reflection of practitioner-based delivery of care.

Understanding cost breakdown in the overall value equation

With regard to value-based care, cost is generally related to money. When broadly explored, however, cost can be broken down into cost to the patient, the health care system, and society this way:

  • patient: time spent receiving evaluation and management from a clinician; money spent for family care needs while undergoing management; money spent for procedures and tests; wages lost due to appointments
  • health system: preventive services versus costly emergency room visit; community-based interventions to improve population health
  • society: cost to tax payers; equitable distribution of vital resources (for example, vaccines); prevention of iatrogenic antibiotic resistance.

To understand how physicians are paid, it is important to see how payers value our services. The Centers for Medicare and Medicaid Services states that it is “promoting value-based care as part of its larger quality strategy to reform how health care is delivered and paid for.” In 2018, the US Department of Health and Human Services is striving to have half of Medicare payments in APMs.3

It is the physician’s responsibility to recognize that costs to the patient, payer, health system, and society can compete with and directly influence the outcome of each other. For example, because the patient pays an insurance premium to participate in a risk pool where cost-sharing is the primary cost-containment strategy, poor-value interventions can directly translate into increased premiums, copayments, or deductibles for the entire pool.4

By clearly identifying the different variables involved in the value-based care equation, residents can better understand their responsibility in their day-to-day work in medicine to address value, not just quality or cost. Clarifying the tenets of value-based care will help guide educators in identifying “teaching moments” and organizing didactic sessions focused on practical implementation of value.

Less is more

In our opening anecdote, the attending shows how curbing overuse of resources can increase the value of care delivered. But that example illustrates only one of the many levels on which educators can help residents understand their impact on value. A multidisciplinary education that incorporates outpatient and inpatient pharmacists, social workers, occupational therapists, pelvic floor physiotherapists, office staff, billing specialists, operating room (OR) technologists, and others can be beneficial in learning how to deliver high-value care.

Read about selecting value-based interventions at work.

 

 

Value-based interventions at work

In the discussion that follows, we illustrate how residents can identify, evaluate, and put into practice value-based interventions that can occur at multiple levels.

Antibiotic selection. Resident choices for outpatient antibiotics can severely affect patient adherence. Subtle differences in the formulation of certain antibiotics affect the price and thus pose a significant potential obstacle. Judicious use of inexpensive drug formulations with fewer dosing frequencies can help patients engage in their own care.

Knowing the pharmacologic difference between doxycycline hyclate and doxycycline monohydrate, for example, is to know the difference between esoteric salts—undeniably worthless information with regard to successfully treating a patient’s infection. Knowing that one formula is on the bargain formulary at the patient’s local pharmacy, or that one drug requires twice-daily dosing versus 4-times-daily dosing, however, can mean the difference between the patient’s adherence or nonadherence to your expert recommendation.

Contraception options. Contraceptives pose a challenge with respect to value because of the myriad delivery systems, doses, and generic formulations available. There are dozens of oral contraceptive pills (OCPs) on the market that vary in their dosing, phasic nature (monophasic, multiphasic), iron content in the hormone-free week, and different progestogens for different conditions (such as drospirenone for androgen excess).

When weighing contraceptive options, the clinician must look at value not only from a cost perspective but also from an effectiveness perspective. The desired outcome in this scenario is preventing unwanted pregnancy with ideal or typical contraceptive use at the most inexpensive price point. When working within the value equation, the clinician must individualize the prescribed contraceptive to one that is most acceptable to the patient and that optimizes the various costs and quality measures. “Cost” can mean the cost of OCPs, menstrual control products, backup contraception, failed or unwanted pregnancy management, or suffering lost wages from missed days of work from, for example, dysmenorrhea. “Quality” can mean a low contraceptive failure rate, predictable cyclicality, the need for patient administration and the risk of forgetting, and the need for backup contraceptives.

In comparing the subdermal contraceptive implant (which can cost up to $1,300 every 3 years, equivalent to $36.11 per month) with OCPs (which can cost as low as $324 for 3 years for an ethinyl estradiol and norgestimate combination, or $9 per month), the OCPs significantly outweigh the implant in terms of cost. When comparing failure rates, the degree of patient intervention, and decreased use of menstrual control products due to amenorrhea, the subdermal contraceptive wins. As we know, long-acting reversible contraception (LARC), including the intrauterine device (IUD) and subdermal implant, is the most effective but often the most expensive contraceptive option.5 When cost is evaluated from a global perspective, as highlighted by the adage “an IUD is cheaper than a baby,” the LARC’s value is derived from its overall high effectiveness and low cost.

If the patient elects to choose OCPs, the clinician should direct the prescription to a pharmacy that has discounted generic pills on its formulary. Generic OCPs have a low- cost burden without loss of efficacy, thus providing maximal value.6 This requires an intimate knowledge of the local pharmacies and what their formularies provide. Sometimes the patient will need to drive out of her way to access cost-effective, quality medications, or the high-value option.

Surgery considerations. Judicious instrument selection in the OR can decrease overall operative costs. While most advanced sealing and cutting instrumentation is for single use, for example, it also can be reprocessed for reuse. Although the cost of reprocessed, single-use instruments is lower, studies evaluating the quality of these instruments “found a significant rate of physical defects, performance issues, or improper decontamination.”7

Marketing largely has driven physician choice in the use of certain vessel sealing and cutting devices, but there has yet to be evidence that using any one device actually improves performance or outcomes, such as length of surgery, blood loss, or postoperative complications. Technology companies that create these instruments likely will have to start designing studies to test performance and outcomes as they relate to their devices to persuade hospital systems that using their products improves outcomes and reduces costs.

While learning laparoscopic hysterectomy, residents may see that some attending surgeons can complete the entire procedure with monopolar scissors, bipolar forceps, and laparoscopic needle drivers, while other surgeons use those instruments plus others, such as a LigaSure instrument or a Harmonic scalpel. With outcomes being the same between these surgeons, it is reasonable for hospitals to audit each surgeon using the Value = Quality ÷ Cost equation and to seek data to describe why the latter surgeon requires additional instrumentation.

Residency training poses a unique opportunity for physicians to learn numerous ways to perform the same procedure so they can fill their armamentarium with various effective techniques. Residency also should be a time in which proficiency with basic surgical instrumentation is emphasized. Attending physicians can help residents improve their skills, for example, by having them use only one advanced sealing and cutting device, or no device at all. This practice will make the trainee better able to adapt to situations in which an advanced device may fail or be unavailable. Future performance metrics may evaluate the physician’s cost effectiveness with regard to single-use instruments during routine surgical procedures.

Standardized order sets. Evidence-based order sets help in the management of pneumonia, sepsis, deep vein thrombosis prophylaxis, and numerous other conditions. In the era of computerized physician order entry systems (CPOEs), a resident needs to enter just a few clicks to order all necessary tests, interventions, and imaging studies for a condition. In one fell swoop, orders are placed not only for admission but also for the patient’s entire hospitalization. The paradox of the order set is that it uses a template to deliver individualized patient-centered care.

In the age of enhanced recovery pathways after surgery, we see patients who undergo a hysterectomy being discharged home directly from the postoperative anesthesia care unit (PACU). Generally, follow-up laboratory testing is not ordered on an outpatient basis. If, however, the patient needs to remain in the hospital for social reasons (such as delayed PACU transfer, transportation, weather), she receives the standardized orders from the post hysterectomy order set: a morning complete blood count ($55) with a basic metabolic panel ($45). As an academic exercise, the order set may help residents learn which orders they must consider when admitting a postoperative hysterectomy patient, but overuse of order sets can be a setback for a value-based care system.

Read about evaluating competence and individualizing care.

 

 

Evaluating competence in value-based care

Research is an integral component of all residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). The implementation of value-based care—with all its nuances, quality metrics, and cost parameters—creates a space for resident-led studies to contribute to peer education. The ACGME’s Obstetrics and Gynecology Milestones project was developed to assess the development of ObGyn residents’ competence as they progress through training. Despite national laws tying reimbursements to value-based care, there is no mention of value as it relates to the basic formula, Value = Quality ÷ Cost, in the project.

With the nuances that value-based care offers, it would behoove the Council on Resident Education in Obstetrics and Gynecology of the American College of Obstetricians and Gynecologists to incorporate a method of evaluation to determine competence in this evolving field.

Care also must be individualized

Academic ObGyns and instructors should focus their pedagogy not only on value-based care but also on individualized care that will maximize desired outcomes for each patient. Incorporating multidisciplinary didactics, focused research, and a 360-degree evaluation in the residency curriculum will create new ObGyns who are known for successfully delivering high-value care.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References
  1. Wieand E, Lagrew DC Jr. Value-based payment: what does it mean, and how can ObGyns get out ahead? OBG Manag. 2018;30(1):17–19, 25–26.
  2. Agency for Healthcare Research and Quality. The six domains of health care quality. https://www.ahrq.gov/professionals/quality-patient-safety/talkingquality/create/sixdomains.html. Reviewed March 2016. Accessed March 22, 2018.
  3. Centers for Medicare and Medicaid Services. Better care. Smarter spending. Healthier people: paying providers for value, not volume. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-01-26-3.html. Published January 26, 2015. Accessed March 22, 2018.
  4. Society for Human Resource Management. Managing health care costs. https://www.shrm.org/resourcesandtools/tools-and-samples/toolkits/pages/managinghealthcarecosts.aspx. Published January 11, 2017. Accessed March 18, 2018.
  5. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice, Long-Acting Reversible Contraception Working Group. ACOG Committee Opinion No. 642: Increasing access to contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet Gynecol. 2015;126(4):e44–e48.
  6. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 375: Brand versus generic oral contraceptives. Obstet Gynecol. 2007;110(2 pt 1):447–448.
  7. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 537: Reprocessed single-use devices. Obstet Gynecol. 2012;120(4):974–976.
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Dr. Woodland is Chair, Department of Obstetrics and Gynecology, Reading Hospital, Tower Health, Reading, Pennsylvania.

The authors report no financial relationships relevant to this article.

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The authors report no financial relationships relevant to this article.

Author and Disclosure Information

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Why are you ordering a CBC on the patient when her white blood cell count, hemoglobin, and platelets have been stable for the past 3 days?” sternly inquired the attending gynecologic oncologist. “Don’t order tests without any clinical indication. If she is infected or bleeding, there will be signs and thus an indication to order a CBC. The physical exam is your test.” There was an authoritative pause before he invoked the “value-based care” maxim.

For many residents who graduated in the past decade, education in value-based care and alternative payment models (APMs) was cobbled together from experience, demonstrated by attendings who labeled it as such, and from rare didactic education classroom sessions and inpatient environments.

In today’s health care environment, professional survival requires the ability to successfully deliver high-value care to patients. Attendings often illustrate and champion how to do this by using patient care to highlight the definition: Value = Quality ÷ Cost.

For residency education programs to create the ObGyns of the future, they must teach trainees what they will be evaluated on and held accountable for.1 Today’s clinicians will have to take responsibility for reigning in health care costs from the fee-for-service era, which in the United States have snowballed into one of the unhealthiest cost-to-outcomes ratios worldwide. Residents will be required to understand not only value but also areas in which they can influence the cost of care and how their outcome metrics are valued.

Modifiable factors in value-based care

As mentioned, value is defined by the equation, Value = Quality ÷ Cost. The granularity of these terms helps clarify the depth and the multitude of levels that clinicians can modify and influence to achieve the highest value.

Quality, as defined by the National Academy of Medicine, includes2:

  • effectiveness: providing care processes and achieving outcomes as supported by scientific evidence
  • efficiency: maximizing the quality of a comparable unit of health care delivered or unit of health benefit achieved for a given unit of health care resources used
  • equity: providing health care of equal quality to those who may differ in personal characteristics other than their clinical condition or preferences for care
  • patient-centeredness: meeting patient needs and preferences and providing education and support
  • safety: actual or potential bodily harm
  • timeliness: obtaining needed care while minimizing delays.

From electronic health records, which were mandated in the Patient Protection and Affordable Care Act of 2010, offices, hospitals, and medical systems have gained robust databases of mineable information. Even data abstraction from paper records has been made easier, allowing better reflection of practitioner-based delivery of care.

Understanding cost breakdown in the overall value equation

With regard to value-based care, cost is generally related to money. When broadly explored, however, cost can be broken down into cost to the patient, the health care system, and society this way:

  • patient: time spent receiving evaluation and management from a clinician; money spent for family care needs while undergoing management; money spent for procedures and tests; wages lost due to appointments
  • health system: preventive services versus costly emergency room visit; community-based interventions to improve population health
  • society: cost to tax payers; equitable distribution of vital resources (for example, vaccines); prevention of iatrogenic antibiotic resistance.

To understand how physicians are paid, it is important to see how payers value our services. The Centers for Medicare and Medicaid Services states that it is “promoting value-based care as part of its larger quality strategy to reform how health care is delivered and paid for.” In 2018, the US Department of Health and Human Services is striving to have half of Medicare payments in APMs.3

It is the physician’s responsibility to recognize that costs to the patient, payer, health system, and society can compete with and directly influence the outcome of each other. For example, because the patient pays an insurance premium to participate in a risk pool where cost-sharing is the primary cost-containment strategy, poor-value interventions can directly translate into increased premiums, copayments, or deductibles for the entire pool.4

By clearly identifying the different variables involved in the value-based care equation, residents can better understand their responsibility in their day-to-day work in medicine to address value, not just quality or cost. Clarifying the tenets of value-based care will help guide educators in identifying “teaching moments” and organizing didactic sessions focused on practical implementation of value.

Less is more

In our opening anecdote, the attending shows how curbing overuse of resources can increase the value of care delivered. But that example illustrates only one of the many levels on which educators can help residents understand their impact on value. A multidisciplinary education that incorporates outpatient and inpatient pharmacists, social workers, occupational therapists, pelvic floor physiotherapists, office staff, billing specialists, operating room (OR) technologists, and others can be beneficial in learning how to deliver high-value care.

Read about selecting value-based interventions at work.

 

 

Value-based interventions at work

In the discussion that follows, we illustrate how residents can identify, evaluate, and put into practice value-based interventions that can occur at multiple levels.

Antibiotic selection. Resident choices for outpatient antibiotics can severely affect patient adherence. Subtle differences in the formulation of certain antibiotics affect the price and thus pose a significant potential obstacle. Judicious use of inexpensive drug formulations with fewer dosing frequencies can help patients engage in their own care.

Knowing the pharmacologic difference between doxycycline hyclate and doxycycline monohydrate, for example, is to know the difference between esoteric salts—undeniably worthless information with regard to successfully treating a patient’s infection. Knowing that one formula is on the bargain formulary at the patient’s local pharmacy, or that one drug requires twice-daily dosing versus 4-times-daily dosing, however, can mean the difference between the patient’s adherence or nonadherence to your expert recommendation.

Contraception options. Contraceptives pose a challenge with respect to value because of the myriad delivery systems, doses, and generic formulations available. There are dozens of oral contraceptive pills (OCPs) on the market that vary in their dosing, phasic nature (monophasic, multiphasic), iron content in the hormone-free week, and different progestogens for different conditions (such as drospirenone for androgen excess).

When weighing contraceptive options, the clinician must look at value not only from a cost perspective but also from an effectiveness perspective. The desired outcome in this scenario is preventing unwanted pregnancy with ideal or typical contraceptive use at the most inexpensive price point. When working within the value equation, the clinician must individualize the prescribed contraceptive to one that is most acceptable to the patient and that optimizes the various costs and quality measures. “Cost” can mean the cost of OCPs, menstrual control products, backup contraception, failed or unwanted pregnancy management, or suffering lost wages from missed days of work from, for example, dysmenorrhea. “Quality” can mean a low contraceptive failure rate, predictable cyclicality, the need for patient administration and the risk of forgetting, and the need for backup contraceptives.

In comparing the subdermal contraceptive implant (which can cost up to $1,300 every 3 years, equivalent to $36.11 per month) with OCPs (which can cost as low as $324 for 3 years for an ethinyl estradiol and norgestimate combination, or $9 per month), the OCPs significantly outweigh the implant in terms of cost. When comparing failure rates, the degree of patient intervention, and decreased use of menstrual control products due to amenorrhea, the subdermal contraceptive wins. As we know, long-acting reversible contraception (LARC), including the intrauterine device (IUD) and subdermal implant, is the most effective but often the most expensive contraceptive option.5 When cost is evaluated from a global perspective, as highlighted by the adage “an IUD is cheaper than a baby,” the LARC’s value is derived from its overall high effectiveness and low cost.

If the patient elects to choose OCPs, the clinician should direct the prescription to a pharmacy that has discounted generic pills on its formulary. Generic OCPs have a low- cost burden without loss of efficacy, thus providing maximal value.6 This requires an intimate knowledge of the local pharmacies and what their formularies provide. Sometimes the patient will need to drive out of her way to access cost-effective, quality medications, or the high-value option.

Surgery considerations. Judicious instrument selection in the OR can decrease overall operative costs. While most advanced sealing and cutting instrumentation is for single use, for example, it also can be reprocessed for reuse. Although the cost of reprocessed, single-use instruments is lower, studies evaluating the quality of these instruments “found a significant rate of physical defects, performance issues, or improper decontamination.”7

Marketing largely has driven physician choice in the use of certain vessel sealing and cutting devices, but there has yet to be evidence that using any one device actually improves performance or outcomes, such as length of surgery, blood loss, or postoperative complications. Technology companies that create these instruments likely will have to start designing studies to test performance and outcomes as they relate to their devices to persuade hospital systems that using their products improves outcomes and reduces costs.

While learning laparoscopic hysterectomy, residents may see that some attending surgeons can complete the entire procedure with monopolar scissors, bipolar forceps, and laparoscopic needle drivers, while other surgeons use those instruments plus others, such as a LigaSure instrument or a Harmonic scalpel. With outcomes being the same between these surgeons, it is reasonable for hospitals to audit each surgeon using the Value = Quality ÷ Cost equation and to seek data to describe why the latter surgeon requires additional instrumentation.

Residency training poses a unique opportunity for physicians to learn numerous ways to perform the same procedure so they can fill their armamentarium with various effective techniques. Residency also should be a time in which proficiency with basic surgical instrumentation is emphasized. Attending physicians can help residents improve their skills, for example, by having them use only one advanced sealing and cutting device, or no device at all. This practice will make the trainee better able to adapt to situations in which an advanced device may fail or be unavailable. Future performance metrics may evaluate the physician’s cost effectiveness with regard to single-use instruments during routine surgical procedures.

Standardized order sets. Evidence-based order sets help in the management of pneumonia, sepsis, deep vein thrombosis prophylaxis, and numerous other conditions. In the era of computerized physician order entry systems (CPOEs), a resident needs to enter just a few clicks to order all necessary tests, interventions, and imaging studies for a condition. In one fell swoop, orders are placed not only for admission but also for the patient’s entire hospitalization. The paradox of the order set is that it uses a template to deliver individualized patient-centered care.

In the age of enhanced recovery pathways after surgery, we see patients who undergo a hysterectomy being discharged home directly from the postoperative anesthesia care unit (PACU). Generally, follow-up laboratory testing is not ordered on an outpatient basis. If, however, the patient needs to remain in the hospital for social reasons (such as delayed PACU transfer, transportation, weather), she receives the standardized orders from the post hysterectomy order set: a morning complete blood count ($55) with a basic metabolic panel ($45). As an academic exercise, the order set may help residents learn which orders they must consider when admitting a postoperative hysterectomy patient, but overuse of order sets can be a setback for a value-based care system.

Read about evaluating competence and individualizing care.

 

 

Evaluating competence in value-based care

Research is an integral component of all residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). The implementation of value-based care—with all its nuances, quality metrics, and cost parameters—creates a space for resident-led studies to contribute to peer education. The ACGME’s Obstetrics and Gynecology Milestones project was developed to assess the development of ObGyn residents’ competence as they progress through training. Despite national laws tying reimbursements to value-based care, there is no mention of value as it relates to the basic formula, Value = Quality ÷ Cost, in the project.

With the nuances that value-based care offers, it would behoove the Council on Resident Education in Obstetrics and Gynecology of the American College of Obstetricians and Gynecologists to incorporate a method of evaluation to determine competence in this evolving field.

Care also must be individualized

Academic ObGyns and instructors should focus their pedagogy not only on value-based care but also on individualized care that will maximize desired outcomes for each patient. Incorporating multidisciplinary didactics, focused research, and a 360-degree evaluation in the residency curriculum will create new ObGyns who are known for successfully delivering high-value care.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Why are you ordering a CBC on the patient when her white blood cell count, hemoglobin, and platelets have been stable for the past 3 days?” sternly inquired the attending gynecologic oncologist. “Don’t order tests without any clinical indication. If she is infected or bleeding, there will be signs and thus an indication to order a CBC. The physical exam is your test.” There was an authoritative pause before he invoked the “value-based care” maxim.

For many residents who graduated in the past decade, education in value-based care and alternative payment models (APMs) was cobbled together from experience, demonstrated by attendings who labeled it as such, and from rare didactic education classroom sessions and inpatient environments.

In today’s health care environment, professional survival requires the ability to successfully deliver high-value care to patients. Attendings often illustrate and champion how to do this by using patient care to highlight the definition: Value = Quality ÷ Cost.

For residency education programs to create the ObGyns of the future, they must teach trainees what they will be evaluated on and held accountable for.1 Today’s clinicians will have to take responsibility for reigning in health care costs from the fee-for-service era, which in the United States have snowballed into one of the unhealthiest cost-to-outcomes ratios worldwide. Residents will be required to understand not only value but also areas in which they can influence the cost of care and how their outcome metrics are valued.

Modifiable factors in value-based care

As mentioned, value is defined by the equation, Value = Quality ÷ Cost. The granularity of these terms helps clarify the depth and the multitude of levels that clinicians can modify and influence to achieve the highest value.

Quality, as defined by the National Academy of Medicine, includes2:

  • effectiveness: providing care processes and achieving outcomes as supported by scientific evidence
  • efficiency: maximizing the quality of a comparable unit of health care delivered or unit of health benefit achieved for a given unit of health care resources used
  • equity: providing health care of equal quality to those who may differ in personal characteristics other than their clinical condition or preferences for care
  • patient-centeredness: meeting patient needs and preferences and providing education and support
  • safety: actual or potential bodily harm
  • timeliness: obtaining needed care while minimizing delays.

From electronic health records, which were mandated in the Patient Protection and Affordable Care Act of 2010, offices, hospitals, and medical systems have gained robust databases of mineable information. Even data abstraction from paper records has been made easier, allowing better reflection of practitioner-based delivery of care.

Understanding cost breakdown in the overall value equation

With regard to value-based care, cost is generally related to money. When broadly explored, however, cost can be broken down into cost to the patient, the health care system, and society this way:

  • patient: time spent receiving evaluation and management from a clinician; money spent for family care needs while undergoing management; money spent for procedures and tests; wages lost due to appointments
  • health system: preventive services versus costly emergency room visit; community-based interventions to improve population health
  • society: cost to tax payers; equitable distribution of vital resources (for example, vaccines); prevention of iatrogenic antibiotic resistance.

To understand how physicians are paid, it is important to see how payers value our services. The Centers for Medicare and Medicaid Services states that it is “promoting value-based care as part of its larger quality strategy to reform how health care is delivered and paid for.” In 2018, the US Department of Health and Human Services is striving to have half of Medicare payments in APMs.3

It is the physician’s responsibility to recognize that costs to the patient, payer, health system, and society can compete with and directly influence the outcome of each other. For example, because the patient pays an insurance premium to participate in a risk pool where cost-sharing is the primary cost-containment strategy, poor-value interventions can directly translate into increased premiums, copayments, or deductibles for the entire pool.4

By clearly identifying the different variables involved in the value-based care equation, residents can better understand their responsibility in their day-to-day work in medicine to address value, not just quality or cost. Clarifying the tenets of value-based care will help guide educators in identifying “teaching moments” and organizing didactic sessions focused on practical implementation of value.

Less is more

In our opening anecdote, the attending shows how curbing overuse of resources can increase the value of care delivered. But that example illustrates only one of the many levels on which educators can help residents understand their impact on value. A multidisciplinary education that incorporates outpatient and inpatient pharmacists, social workers, occupational therapists, pelvic floor physiotherapists, office staff, billing specialists, operating room (OR) technologists, and others can be beneficial in learning how to deliver high-value care.

Read about selecting value-based interventions at work.

 

 

Value-based interventions at work

In the discussion that follows, we illustrate how residents can identify, evaluate, and put into practice value-based interventions that can occur at multiple levels.

Antibiotic selection. Resident choices for outpatient antibiotics can severely affect patient adherence. Subtle differences in the formulation of certain antibiotics affect the price and thus pose a significant potential obstacle. Judicious use of inexpensive drug formulations with fewer dosing frequencies can help patients engage in their own care.

Knowing the pharmacologic difference between doxycycline hyclate and doxycycline monohydrate, for example, is to know the difference between esoteric salts—undeniably worthless information with regard to successfully treating a patient’s infection. Knowing that one formula is on the bargain formulary at the patient’s local pharmacy, or that one drug requires twice-daily dosing versus 4-times-daily dosing, however, can mean the difference between the patient’s adherence or nonadherence to your expert recommendation.

Contraception options. Contraceptives pose a challenge with respect to value because of the myriad delivery systems, doses, and generic formulations available. There are dozens of oral contraceptive pills (OCPs) on the market that vary in their dosing, phasic nature (monophasic, multiphasic), iron content in the hormone-free week, and different progestogens for different conditions (such as drospirenone for androgen excess).

When weighing contraceptive options, the clinician must look at value not only from a cost perspective but also from an effectiveness perspective. The desired outcome in this scenario is preventing unwanted pregnancy with ideal or typical contraceptive use at the most inexpensive price point. When working within the value equation, the clinician must individualize the prescribed contraceptive to one that is most acceptable to the patient and that optimizes the various costs and quality measures. “Cost” can mean the cost of OCPs, menstrual control products, backup contraception, failed or unwanted pregnancy management, or suffering lost wages from missed days of work from, for example, dysmenorrhea. “Quality” can mean a low contraceptive failure rate, predictable cyclicality, the need for patient administration and the risk of forgetting, and the need for backup contraceptives.

In comparing the subdermal contraceptive implant (which can cost up to $1,300 every 3 years, equivalent to $36.11 per month) with OCPs (which can cost as low as $324 for 3 years for an ethinyl estradiol and norgestimate combination, or $9 per month), the OCPs significantly outweigh the implant in terms of cost. When comparing failure rates, the degree of patient intervention, and decreased use of menstrual control products due to amenorrhea, the subdermal contraceptive wins. As we know, long-acting reversible contraception (LARC), including the intrauterine device (IUD) and subdermal implant, is the most effective but often the most expensive contraceptive option.5 When cost is evaluated from a global perspective, as highlighted by the adage “an IUD is cheaper than a baby,” the LARC’s value is derived from its overall high effectiveness and low cost.

If the patient elects to choose OCPs, the clinician should direct the prescription to a pharmacy that has discounted generic pills on its formulary. Generic OCPs have a low- cost burden without loss of efficacy, thus providing maximal value.6 This requires an intimate knowledge of the local pharmacies and what their formularies provide. Sometimes the patient will need to drive out of her way to access cost-effective, quality medications, or the high-value option.

Surgery considerations. Judicious instrument selection in the OR can decrease overall operative costs. While most advanced sealing and cutting instrumentation is for single use, for example, it also can be reprocessed for reuse. Although the cost of reprocessed, single-use instruments is lower, studies evaluating the quality of these instruments “found a significant rate of physical defects, performance issues, or improper decontamination.”7

Marketing largely has driven physician choice in the use of certain vessel sealing and cutting devices, but there has yet to be evidence that using any one device actually improves performance or outcomes, such as length of surgery, blood loss, or postoperative complications. Technology companies that create these instruments likely will have to start designing studies to test performance and outcomes as they relate to their devices to persuade hospital systems that using their products improves outcomes and reduces costs.

While learning laparoscopic hysterectomy, residents may see that some attending surgeons can complete the entire procedure with monopolar scissors, bipolar forceps, and laparoscopic needle drivers, while other surgeons use those instruments plus others, such as a LigaSure instrument or a Harmonic scalpel. With outcomes being the same between these surgeons, it is reasonable for hospitals to audit each surgeon using the Value = Quality ÷ Cost equation and to seek data to describe why the latter surgeon requires additional instrumentation.

Residency training poses a unique opportunity for physicians to learn numerous ways to perform the same procedure so they can fill their armamentarium with various effective techniques. Residency also should be a time in which proficiency with basic surgical instrumentation is emphasized. Attending physicians can help residents improve their skills, for example, by having them use only one advanced sealing and cutting device, or no device at all. This practice will make the trainee better able to adapt to situations in which an advanced device may fail or be unavailable. Future performance metrics may evaluate the physician’s cost effectiveness with regard to single-use instruments during routine surgical procedures.

Standardized order sets. Evidence-based order sets help in the management of pneumonia, sepsis, deep vein thrombosis prophylaxis, and numerous other conditions. In the era of computerized physician order entry systems (CPOEs), a resident needs to enter just a few clicks to order all necessary tests, interventions, and imaging studies for a condition. In one fell swoop, orders are placed not only for admission but also for the patient’s entire hospitalization. The paradox of the order set is that it uses a template to deliver individualized patient-centered care.

In the age of enhanced recovery pathways after surgery, we see patients who undergo a hysterectomy being discharged home directly from the postoperative anesthesia care unit (PACU). Generally, follow-up laboratory testing is not ordered on an outpatient basis. If, however, the patient needs to remain in the hospital for social reasons (such as delayed PACU transfer, transportation, weather), she receives the standardized orders from the post hysterectomy order set: a morning complete blood count ($55) with a basic metabolic panel ($45). As an academic exercise, the order set may help residents learn which orders they must consider when admitting a postoperative hysterectomy patient, but overuse of order sets can be a setback for a value-based care system.

Read about evaluating competence and individualizing care.

 

 

Evaluating competence in value-based care

Research is an integral component of all residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). The implementation of value-based care—with all its nuances, quality metrics, and cost parameters—creates a space for resident-led studies to contribute to peer education. The ACGME’s Obstetrics and Gynecology Milestones project was developed to assess the development of ObGyn residents’ competence as they progress through training. Despite national laws tying reimbursements to value-based care, there is no mention of value as it relates to the basic formula, Value = Quality ÷ Cost, in the project.

With the nuances that value-based care offers, it would behoove the Council on Resident Education in Obstetrics and Gynecology of the American College of Obstetricians and Gynecologists to incorporate a method of evaluation to determine competence in this evolving field.

Care also must be individualized

Academic ObGyns and instructors should focus their pedagogy not only on value-based care but also on individualized care that will maximize desired outcomes for each patient. Incorporating multidisciplinary didactics, focused research, and a 360-degree evaluation in the residency curriculum will create new ObGyns who are known for successfully delivering high-value care.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References
  1. Wieand E, Lagrew DC Jr. Value-based payment: what does it mean, and how can ObGyns get out ahead? OBG Manag. 2018;30(1):17–19, 25–26.
  2. Agency for Healthcare Research and Quality. The six domains of health care quality. https://www.ahrq.gov/professionals/quality-patient-safety/talkingquality/create/sixdomains.html. Reviewed March 2016. Accessed March 22, 2018.
  3. Centers for Medicare and Medicaid Services. Better care. Smarter spending. Healthier people: paying providers for value, not volume. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-01-26-3.html. Published January 26, 2015. Accessed March 22, 2018.
  4. Society for Human Resource Management. Managing health care costs. https://www.shrm.org/resourcesandtools/tools-and-samples/toolkits/pages/managinghealthcarecosts.aspx. Published January 11, 2017. Accessed March 18, 2018.
  5. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice, Long-Acting Reversible Contraception Working Group. ACOG Committee Opinion No. 642: Increasing access to contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet Gynecol. 2015;126(4):e44–e48.
  6. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 375: Brand versus generic oral contraceptives. Obstet Gynecol. 2007;110(2 pt 1):447–448.
  7. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 537: Reprocessed single-use devices. Obstet Gynecol. 2012;120(4):974–976.
References
  1. Wieand E, Lagrew DC Jr. Value-based payment: what does it mean, and how can ObGyns get out ahead? OBG Manag. 2018;30(1):17–19, 25–26.
  2. Agency for Healthcare Research and Quality. The six domains of health care quality. https://www.ahrq.gov/professionals/quality-patient-safety/talkingquality/create/sixdomains.html. Reviewed March 2016. Accessed March 22, 2018.
  3. Centers for Medicare and Medicaid Services. Better care. Smarter spending. Healthier people: paying providers for value, not volume. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-01-26-3.html. Published January 26, 2015. Accessed March 22, 2018.
  4. Society for Human Resource Management. Managing health care costs. https://www.shrm.org/resourcesandtools/tools-and-samples/toolkits/pages/managinghealthcarecosts.aspx. Published January 11, 2017. Accessed March 18, 2018.
  5. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice, Long-Acting Reversible Contraception Working Group. ACOG Committee Opinion No. 642: Increasing access to contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet Gynecol. 2015;126(4):e44–e48.
  6. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 375: Brand versus generic oral contraceptives. Obstet Gynecol. 2007;110(2 pt 1):447–448.
  7. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 537: Reprocessed single-use devices. Obstet Gynecol. 2012;120(4):974–976.
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The Right Choice? Mixed feelings about a recent informed consent court decision

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On June 20, 2017, the Supreme Court of Pennsylvania ruled on a case that may have significant implications for surgical informed consent.

Although the legal complexities of the case might be interesting to some, what got my attention was the question of whether a surgeon can delegate the informed consent discussion with a patient to someone else.

Dr. Peter Angelos
The case, Shinal v. Toms, involved a malpractice claim arising from a neurosurgical procedure. Megan Shinal had met with Steven Toms, MD, to discuss removal of a benign pituitary tumor (“Shinal vs. Toms: It is now harder to get informed consent,” ACS Surgery News, Sept. 10, 2017). Apparently several options for the surgical approach were discussed at that consultation and Ms. Shinal had reportedly agreed to have surgery.

A few weeks later, the patient had a phone conversation with Dr. Tom’s physician assistant (PA) who answered several additional questions Ms. Shinal had about the surgery. Approximately one month later, the patient met with the same PA and had a preoperative history and physical examination and the informed consent form was signed.

About 2 weeks after that, the patient had an open craniotomy with total resection of the tumor. Unfortunately, the procedure was complicated by bleeding that resulted in stroke, brain injury, and partial blindness. Ms. Shinal and her husband sued Dr. Toms for malpractice, and included in the suit was a claim that Dr. Toms failed to obtain informed consent from Ms. Shinal.

At the original trial, the jury was instructed by the judge to consider information given to Ms. Shinal both by Dr. Toms and his PA as included in the informed consent process. The jury found in favor of Dr. Toms and the patient then appealed to the Pennsylvania Superior Court which upheld the decision. The case was then appealed to the Pennsylvania Supreme Court, which specifically addressed the issue of whether the informed consent discussion must be performed by the surgeon or can be delegated to others.

Several groups, including the American Medical Association, filed briefs in the case supporting Dr. Tom’s claim that the information that is conveyed in the informed consent process is what is important rather than exactly who provides that information to the patient. For many, this case seemed to be relatively straightforward. The surgeon had discussed the operation with the patient, she had agreed, and then in several additional conversations with the surgeon’s PA, the patient’s additional questions had been answered and the patient had willingly signed the informed consent document.
 

 


However, in a surprise to many, the Pennsylvania Supreme Court decision stated that “a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patients’ informed consent. Informed consent requires direct communication between physician and patient and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.” Based on this finding, the case was sent back to the trial court for a new trial.

Although legal scholars may debate the legal basis of this opinion and the ramifications for future cases, I am more interested in the ethical issues that it raises. Although, in recent decades, I have become increasingly accustomed to the idea of medical care by teams, there is something almost nostalgic about this decision. It suggests to me that at least four of the seven Pennsylvania Supreme Court justices believe that there is something so special about surgical informed consent that it must involve a direct conversation between the patient and the surgeon.

This view seems ever more foreign in an environment in which we increasingly talk about processes of care and systems errors rather than individual relationships and individual responsibility. Although the supremely hierarchical concept of the surgeon as the “captain of the ship” has largely been replaced by the team approach, it is nevertheless true that, in an elective case, the patient would not be in the operating room but for the relationship and trust that the patient has in the surgeon.

As I contemplate this court case, I see how it may add to the challenges of providing surgical care to patients and how it may further the delays to see some surgeons. However, it also reemphasizes for me that informed consent for surgery is less about the information that is transferred to the patient and much more about the relationship in which a patient places his or her trust in the surgeon. The emphasis that this court ruling places on the direct relationship between a surgeon and a patient is a refreshing reminder of the personal responsibility that surgeons have for their patients’ outcomes.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

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On June 20, 2017, the Supreme Court of Pennsylvania ruled on a case that may have significant implications for surgical informed consent.

Although the legal complexities of the case might be interesting to some, what got my attention was the question of whether a surgeon can delegate the informed consent discussion with a patient to someone else.

Dr. Peter Angelos
The case, Shinal v. Toms, involved a malpractice claim arising from a neurosurgical procedure. Megan Shinal had met with Steven Toms, MD, to discuss removal of a benign pituitary tumor (“Shinal vs. Toms: It is now harder to get informed consent,” ACS Surgery News, Sept. 10, 2017). Apparently several options for the surgical approach were discussed at that consultation and Ms. Shinal had reportedly agreed to have surgery.

A few weeks later, the patient had a phone conversation with Dr. Tom’s physician assistant (PA) who answered several additional questions Ms. Shinal had about the surgery. Approximately one month later, the patient met with the same PA and had a preoperative history and physical examination and the informed consent form was signed.

About 2 weeks after that, the patient had an open craniotomy with total resection of the tumor. Unfortunately, the procedure was complicated by bleeding that resulted in stroke, brain injury, and partial blindness. Ms. Shinal and her husband sued Dr. Toms for malpractice, and included in the suit was a claim that Dr. Toms failed to obtain informed consent from Ms. Shinal.

At the original trial, the jury was instructed by the judge to consider information given to Ms. Shinal both by Dr. Toms and his PA as included in the informed consent process. The jury found in favor of Dr. Toms and the patient then appealed to the Pennsylvania Superior Court which upheld the decision. The case was then appealed to the Pennsylvania Supreme Court, which specifically addressed the issue of whether the informed consent discussion must be performed by the surgeon or can be delegated to others.

Several groups, including the American Medical Association, filed briefs in the case supporting Dr. Tom’s claim that the information that is conveyed in the informed consent process is what is important rather than exactly who provides that information to the patient. For many, this case seemed to be relatively straightforward. The surgeon had discussed the operation with the patient, she had agreed, and then in several additional conversations with the surgeon’s PA, the patient’s additional questions had been answered and the patient had willingly signed the informed consent document.
 

 


However, in a surprise to many, the Pennsylvania Supreme Court decision stated that “a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patients’ informed consent. Informed consent requires direct communication between physician and patient and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.” Based on this finding, the case was sent back to the trial court for a new trial.

Although legal scholars may debate the legal basis of this opinion and the ramifications for future cases, I am more interested in the ethical issues that it raises. Although, in recent decades, I have become increasingly accustomed to the idea of medical care by teams, there is something almost nostalgic about this decision. It suggests to me that at least four of the seven Pennsylvania Supreme Court justices believe that there is something so special about surgical informed consent that it must involve a direct conversation between the patient and the surgeon.

This view seems ever more foreign in an environment in which we increasingly talk about processes of care and systems errors rather than individual relationships and individual responsibility. Although the supremely hierarchical concept of the surgeon as the “captain of the ship” has largely been replaced by the team approach, it is nevertheless true that, in an elective case, the patient would not be in the operating room but for the relationship and trust that the patient has in the surgeon.

As I contemplate this court case, I see how it may add to the challenges of providing surgical care to patients and how it may further the delays to see some surgeons. However, it also reemphasizes for me that informed consent for surgery is less about the information that is transferred to the patient and much more about the relationship in which a patient places his or her trust in the surgeon. The emphasis that this court ruling places on the direct relationship between a surgeon and a patient is a refreshing reminder of the personal responsibility that surgeons have for their patients’ outcomes.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

 

On June 20, 2017, the Supreme Court of Pennsylvania ruled on a case that may have significant implications for surgical informed consent.

Although the legal complexities of the case might be interesting to some, what got my attention was the question of whether a surgeon can delegate the informed consent discussion with a patient to someone else.

Dr. Peter Angelos
The case, Shinal v. Toms, involved a malpractice claim arising from a neurosurgical procedure. Megan Shinal had met with Steven Toms, MD, to discuss removal of a benign pituitary tumor (“Shinal vs. Toms: It is now harder to get informed consent,” ACS Surgery News, Sept. 10, 2017). Apparently several options for the surgical approach were discussed at that consultation and Ms. Shinal had reportedly agreed to have surgery.

A few weeks later, the patient had a phone conversation with Dr. Tom’s physician assistant (PA) who answered several additional questions Ms. Shinal had about the surgery. Approximately one month later, the patient met with the same PA and had a preoperative history and physical examination and the informed consent form was signed.

About 2 weeks after that, the patient had an open craniotomy with total resection of the tumor. Unfortunately, the procedure was complicated by bleeding that resulted in stroke, brain injury, and partial blindness. Ms. Shinal and her husband sued Dr. Toms for malpractice, and included in the suit was a claim that Dr. Toms failed to obtain informed consent from Ms. Shinal.

At the original trial, the jury was instructed by the judge to consider information given to Ms. Shinal both by Dr. Toms and his PA as included in the informed consent process. The jury found in favor of Dr. Toms and the patient then appealed to the Pennsylvania Superior Court which upheld the decision. The case was then appealed to the Pennsylvania Supreme Court, which specifically addressed the issue of whether the informed consent discussion must be performed by the surgeon or can be delegated to others.

Several groups, including the American Medical Association, filed briefs in the case supporting Dr. Tom’s claim that the information that is conveyed in the informed consent process is what is important rather than exactly who provides that information to the patient. For many, this case seemed to be relatively straightforward. The surgeon had discussed the operation with the patient, she had agreed, and then in several additional conversations with the surgeon’s PA, the patient’s additional questions had been answered and the patient had willingly signed the informed consent document.
 

 


However, in a surprise to many, the Pennsylvania Supreme Court decision stated that “a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patients’ informed consent. Informed consent requires direct communication between physician and patient and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.” Based on this finding, the case was sent back to the trial court for a new trial.

Although legal scholars may debate the legal basis of this opinion and the ramifications for future cases, I am more interested in the ethical issues that it raises. Although, in recent decades, I have become increasingly accustomed to the idea of medical care by teams, there is something almost nostalgic about this decision. It suggests to me that at least four of the seven Pennsylvania Supreme Court justices believe that there is something so special about surgical informed consent that it must involve a direct conversation between the patient and the surgeon.

This view seems ever more foreign in an environment in which we increasingly talk about processes of care and systems errors rather than individual relationships and individual responsibility. Although the supremely hierarchical concept of the surgeon as the “captain of the ship” has largely been replaced by the team approach, it is nevertheless true that, in an elective case, the patient would not be in the operating room but for the relationship and trust that the patient has in the surgeon.

As I contemplate this court case, I see how it may add to the challenges of providing surgical care to patients and how it may further the delays to see some surgeons. However, it also reemphasizes for me that informed consent for surgery is less about the information that is transferred to the patient and much more about the relationship in which a patient places his or her trust in the surgeon. The emphasis that this court ruling places on the direct relationship between a surgeon and a patient is a refreshing reminder of the personal responsibility that surgeons have for their patients’ outcomes.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

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Patient experience: It’s not about satisfaction

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Patient experience: It’s not about satisfaction

My pager went off 20 minutes into my case. The circulating nurse announced that it was the chief of staff’s office, and as I migrated over to the phone, everyone was wondering what I had done to warrant a call from the boss. The nurse held the phone to my ear and Dr. Joe Hahn, a neurosurgeon and second-in-command at Cleveland Clinic, congratulated me: “You’re it,” he said. I thanked him and went back to work. My scrub tech wanted to know what happened. I told him I was just appointed chief experience officer at Cleveland Clinic. With a befuddled look, he asked what that meant. I said I wasn’t sure.

Jim gets a fast lesson on how to lead patient experience

Patient experience was a signature issue for Dr. Toby Cosgrove, our then president and chief executive officer. Although the Clinic was revered for its high-quality care, patients did not always like going there. Dr. Cosgrove passionately believed that providing a high-quality experience was as important as the best medical care, and that the experience at the Clinic needed to be improved. Another physician had held the role of chief experience officer before me, but she came from outside the system and was not practicing, which proved to be a challenge in the Clinic’s physician-dominated culture. Dr. Cosgrove wanted a physician who “grew up” in the organization to lead this initiative.

When I left my initial interview with Dr. Cosgrove, I could not define patient experience, did not know what HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) was—at the time were in the 10th percentile—and frankly had no idea how I would move a culture of 45,000 people, including 3,000 employed physicians, to embrace patient-centricity. By the time I left the Clinic in 2015, however, we had pushed our experience scores to the top quartile, realigned our culture, and had become world renown for patient experience.1

I knew intuitively that improving the patient experience was the right thing to do. In 2004, my father had died at the Clinic from surgical complications; his experience had been terrible. At that time, we did not use the term experience, but based on the items that hospitals are graded on today, my father would have failed us on all of them.

What is patient experience?

Patient experience is not about making people happy. Fundamentally, it is about delivering safe, high-quality, patient-centric care. A 2017 Press Ganey analysis of publicly reported data from the Centers for Medicaid and Medicare demonstrated that when performance on experience measures is high, safety and quality also are high.2 Similarly, in 2015, JAMA published an article using data from the National Surgical Quality Improvement Project demonstrating a significant association between patient experience scores and several objective measures of surgical quality, including mortality and complications.3

In my new role, I mercilessly told my father’s story, changed the narrative to include safety and quality, and asked my physician colleagues for their help to improve patient experience. People in health care pay very close attention to what physicians do and say, and I needed the doctors to “own it” if we were going to implement the desired change.

I also had to convince them to see themselves on the “other side.” It was not just a matter of “treating patients the way you would want to be treated.” It was about putting yourself in your patients’ shoes—having empathy for what they are experiencing and recognizing that you or a family member could be sitting in that bed. Before my father was ill, I had never been on the other side so intimately, and it was an eye-opening experience.

Retooling communication competency

For the physicians, we zeroed in on helping them improve how they communicate with patients. Communication is a high-value target for experience improvement, and it directly influences safety and quality. We produced a physician-centric communication guide that provided useful tips (see “Practical tips to help physicians improve communication with patients”). We made communication scores transparent. In addition, working with the American Academy on Communication in Healthcare (AACH), we developed a program specifically designed to help physicians improve their communication skills and practice management.4 The outcome was not only better scores but also higher physician engagement and lower burnout.5

Practical tips to help physicians improve communication with patients
  • Introduce yourself and your role
  • Address the patient by name and use common courtesy
  • Make nursing your partner
  • Ensure that the patient knows and understands the plan of care
  • Explain what the patient can expect (tests, procedures, consultations)
  • Address questions
  • Understand that house staff, care partners, and consultants impact your communication scores
  • Respect the patient's privacy
  • Be aware of what you do and say in front of patients
  • Include the patient's family when appropriate
  • Ask patients and visitors how they are being treated and if they need anything
  • Discuss pain management and set expectations
  • When necessary, apologize--try to right a wrong
  • Role model good behavior and address bad behavior

Keeping it real

Being married to another member of the medical staff—a strong-willed and opinionated one at that—ensured that my strategic approach to improving patient experience was grounded. It gave me a safe place to test ideas and concepts, which in turn allowed me to keep my instincts framed and relevant to the needs of key stakeholders, particularly the physicians.

Read what the ObGyn wife has to say.

 

 

The ObGyn wife tells her side

When my husband was appointed chief experience officer, I naturally was happy for his accomplishment but admitted that I was not sure exactly what it meant. What was he going to be doing? Would he give up surgery, which he loved?

The experience “thing” always had been fuzzy to me. I equated experience with satisfaction, and I saw my primary role as taking care of patients, not making them happy. I believed that I had great patient relationships, so what else did I need to know to contribute to this work? The connection to safety and quality did resonate with me, though, and it made talking about patient experience more tangible.

When Jim started teasing apart what steps needed to be taken, improving the culture seemed like an obvious focus. One thing was clear: He would need to get the physicians on board by helping them to see the practical importance of this work. It could not be gimmicky or too touchy-feely. The work had to be relevant and tangible to their everyday practice. One thing he said struck a chord: “Everyone comes to health care to help people, and we all believe we are the best we can be, but clearly there are opportunities to improve, and evolve our skills.” I started to consider specific circumstances in which that made sense.

Practice to be a better communicator

Improving physician communication was a top priority. I believed that I was a very good communicator, so I was not sure I would learn much from participating in a required day-long session designed by the AACH.

For this program we convened in small groups of 8 to 10 physicians, and each person paired with a partner. The course provided an important framework that would help us to better organize the patient encounter, an approach that no one had ever taught me. It showed me how to leverage the patient’s chief complaint to empower her to set the agenda. This would avoid unnecessary and inefficient conversational tangents, such as the doorknob question—when the patient brings up the real reason for the visit as you are leaving the exam room.

The course also taught me that while I was a good communicator, I was not efficient. I learned how to listen more effectively. Notably, how we manage patients and how we communicate are learned skills, just like mastering a new surgical procedure. High performance requires thoughtful review and practice.

Work on relationship skills

I had professional colleagues who were difficult to work with or, as I knew from covering for them, had terrible relationships with patients. These interactions made my job harder and directly influenced patient care. I always found it distasteful to hear, “Dr. X treats people very poorly, but he or she is such a great doctor.” Should not doctors be both excellent at their work and excel at the human relationship side of the business? Maybe we did need to work on certain things.

An early Cleveland Clinic initiative was to immerse every employee, including physicians, in a half-day appreciative-inquiry exercise. This entailed sitting around a table with other randomly selected caregivers—a nurse, valet, environmental service worker, administrator—and discussing various topics, such as our role in the organization, teamwork, and the servant-leader philosophy. Going into this exercise, I was skeptical. But going through it fostered a deeper understanding of how we all need to work better together to drive safe, high-quality patient care. It made me reflect on what patients go through every day and the critical contribution each team member makes. The program made me think about what we do and created greater appreciation and mindfulness of our work.

Think empathy

One of the most impactful efforts was getting people to understand and appreciate being on the other side of health care. The patient experience team crafted an empathy video that showcased people—patients, families, caregivers, physicians—and their thoughts as they experienced the other side of health care. The video frames what they are thinking about in the moment and is a powerful reminder that each person has something happening in their life that affects their daily experiences. The empathy video has been viewed by millions around the world. (See “Empathy: The human connection to patient care,” at https://www.youtube.com/watch?v=cDDWvj_q-o8.)

Together we embraced the work

Amy and I shared a unique perspective on this work as the leader of the experience improvement initiative, married to a person experiencing it. We both came to realize that we did not know all there is to know about how to deliver high-quality patient care. Improving experience is both complex and highly nuanced, and it is a vital component of what we do as physicians. The Clinic’s efforts moved the organization to high performance, and everyone played a role. However, we would not have succeeded without the engagement of physician leaders.

Making patients and families happy was never part of the equation. It is about reducing patient suffering and delivering safe, high-quality care in an environment where people feel cared for. That is what the people we serve desire, and it is what we want for ourselves. Although there will always be doubters, especially among physicians, of the importance of patient experience, we must never lose sight that this is the right thing to do for our patients, our families, and ourselves.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References
  1. Merlino JI, Raman A. Health care's service fanatics: How the Cleveland Clinic leaped to the top of patient-satisfaction surveys. Harvard Business Review. 2013;91(5):108-116.
  2. Press Ganey 2016 Strategic Insights. Performance redefined: As healthcare moves from volume to value, the streams of quality are coming together. http://www.pressganey.com/resources/white-papers/2016-strategic-insights-performance-redefined. Published March 22, 2016. Accessed March 20, 2018.
  3. Sacks GD, Lawson EH, Dawes AJ, et al. Relationship between hospital performance on a patient satisfaction survey and surgical quality. JAMA Surg. 2015;150(9):858-864.
  4. Merlino JI, Coulton RW. Enhancing physician communication with patients at Cleveland Clinic. Group Practice J. 2012;61(2):24-32.
  5. Boissy A, Windover AK, Bokar D, et al. Communication skills training for physicians improves patient satisfaction. J Gen Intern Med. 2016;31(7):755-761.
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James I. Merlino, MD, is President and Chief Medical Officer of Advisory and Strategic Consulting at Press Ganey Associates, Cleveland, Ohio.

Amy A. Merlino, MD, is a Maternal Fetal Medicine Specialist in the Department of Obstetrics and Gynecology, and Enterprise Chief Medical Information Officer at the Cleveland Clinic, Cleveland, Ohio.

The authors report no financial relationships relevant to this article.

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James I. Merlino, MD, is President and Chief Medical Officer of Advisory and Strategic Consulting at Press Ganey Associates, Cleveland, Ohio.

Amy A. Merlino, MD, is a Maternal Fetal Medicine Specialist in the Department of Obstetrics and Gynecology, and Enterprise Chief Medical Information Officer at the Cleveland Clinic, Cleveland, Ohio.

The authors report no financial relationships relevant to this article.

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James I. Merlino, MD, is President and Chief Medical Officer of Advisory and Strategic Consulting at Press Ganey Associates, Cleveland, Ohio.

Amy A. Merlino, MD, is a Maternal Fetal Medicine Specialist in the Department of Obstetrics and Gynecology, and Enterprise Chief Medical Information Officer at the Cleveland Clinic, Cleveland, Ohio.

The authors report no financial relationships relevant to this article.

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My pager went off 20 minutes into my case. The circulating nurse announced that it was the chief of staff’s office, and as I migrated over to the phone, everyone was wondering what I had done to warrant a call from the boss. The nurse held the phone to my ear and Dr. Joe Hahn, a neurosurgeon and second-in-command at Cleveland Clinic, congratulated me: “You’re it,” he said. I thanked him and went back to work. My scrub tech wanted to know what happened. I told him I was just appointed chief experience officer at Cleveland Clinic. With a befuddled look, he asked what that meant. I said I wasn’t sure.

Jim gets a fast lesson on how to lead patient experience

Patient experience was a signature issue for Dr. Toby Cosgrove, our then president and chief executive officer. Although the Clinic was revered for its high-quality care, patients did not always like going there. Dr. Cosgrove passionately believed that providing a high-quality experience was as important as the best medical care, and that the experience at the Clinic needed to be improved. Another physician had held the role of chief experience officer before me, but she came from outside the system and was not practicing, which proved to be a challenge in the Clinic’s physician-dominated culture. Dr. Cosgrove wanted a physician who “grew up” in the organization to lead this initiative.

When I left my initial interview with Dr. Cosgrove, I could not define patient experience, did not know what HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) was—at the time were in the 10th percentile—and frankly had no idea how I would move a culture of 45,000 people, including 3,000 employed physicians, to embrace patient-centricity. By the time I left the Clinic in 2015, however, we had pushed our experience scores to the top quartile, realigned our culture, and had become world renown for patient experience.1

I knew intuitively that improving the patient experience was the right thing to do. In 2004, my father had died at the Clinic from surgical complications; his experience had been terrible. At that time, we did not use the term experience, but based on the items that hospitals are graded on today, my father would have failed us on all of them.

What is patient experience?

Patient experience is not about making people happy. Fundamentally, it is about delivering safe, high-quality, patient-centric care. A 2017 Press Ganey analysis of publicly reported data from the Centers for Medicaid and Medicare demonstrated that when performance on experience measures is high, safety and quality also are high.2 Similarly, in 2015, JAMA published an article using data from the National Surgical Quality Improvement Project demonstrating a significant association between patient experience scores and several objective measures of surgical quality, including mortality and complications.3

In my new role, I mercilessly told my father’s story, changed the narrative to include safety and quality, and asked my physician colleagues for their help to improve patient experience. People in health care pay very close attention to what physicians do and say, and I needed the doctors to “own it” if we were going to implement the desired change.

I also had to convince them to see themselves on the “other side.” It was not just a matter of “treating patients the way you would want to be treated.” It was about putting yourself in your patients’ shoes—having empathy for what they are experiencing and recognizing that you or a family member could be sitting in that bed. Before my father was ill, I had never been on the other side so intimately, and it was an eye-opening experience.

Retooling communication competency

For the physicians, we zeroed in on helping them improve how they communicate with patients. Communication is a high-value target for experience improvement, and it directly influences safety and quality. We produced a physician-centric communication guide that provided useful tips (see “Practical tips to help physicians improve communication with patients”). We made communication scores transparent. In addition, working with the American Academy on Communication in Healthcare (AACH), we developed a program specifically designed to help physicians improve their communication skills and practice management.4 The outcome was not only better scores but also higher physician engagement and lower burnout.5

Practical tips to help physicians improve communication with patients
  • Introduce yourself and your role
  • Address the patient by name and use common courtesy
  • Make nursing your partner
  • Ensure that the patient knows and understands the plan of care
  • Explain what the patient can expect (tests, procedures, consultations)
  • Address questions
  • Understand that house staff, care partners, and consultants impact your communication scores
  • Respect the patient's privacy
  • Be aware of what you do and say in front of patients
  • Include the patient's family when appropriate
  • Ask patients and visitors how they are being treated and if they need anything
  • Discuss pain management and set expectations
  • When necessary, apologize--try to right a wrong
  • Role model good behavior and address bad behavior

Keeping it real

Being married to another member of the medical staff—a strong-willed and opinionated one at that—ensured that my strategic approach to improving patient experience was grounded. It gave me a safe place to test ideas and concepts, which in turn allowed me to keep my instincts framed and relevant to the needs of key stakeholders, particularly the physicians.

Read what the ObGyn wife has to say.

 

 

The ObGyn wife tells her side

When my husband was appointed chief experience officer, I naturally was happy for his accomplishment but admitted that I was not sure exactly what it meant. What was he going to be doing? Would he give up surgery, which he loved?

The experience “thing” always had been fuzzy to me. I equated experience with satisfaction, and I saw my primary role as taking care of patients, not making them happy. I believed that I had great patient relationships, so what else did I need to know to contribute to this work? The connection to safety and quality did resonate with me, though, and it made talking about patient experience more tangible.

When Jim started teasing apart what steps needed to be taken, improving the culture seemed like an obvious focus. One thing was clear: He would need to get the physicians on board by helping them to see the practical importance of this work. It could not be gimmicky or too touchy-feely. The work had to be relevant and tangible to their everyday practice. One thing he said struck a chord: “Everyone comes to health care to help people, and we all believe we are the best we can be, but clearly there are opportunities to improve, and evolve our skills.” I started to consider specific circumstances in which that made sense.

Practice to be a better communicator

Improving physician communication was a top priority. I believed that I was a very good communicator, so I was not sure I would learn much from participating in a required day-long session designed by the AACH.

For this program we convened in small groups of 8 to 10 physicians, and each person paired with a partner. The course provided an important framework that would help us to better organize the patient encounter, an approach that no one had ever taught me. It showed me how to leverage the patient’s chief complaint to empower her to set the agenda. This would avoid unnecessary and inefficient conversational tangents, such as the doorknob question—when the patient brings up the real reason for the visit as you are leaving the exam room.

The course also taught me that while I was a good communicator, I was not efficient. I learned how to listen more effectively. Notably, how we manage patients and how we communicate are learned skills, just like mastering a new surgical procedure. High performance requires thoughtful review and practice.

Work on relationship skills

I had professional colleagues who were difficult to work with or, as I knew from covering for them, had terrible relationships with patients. These interactions made my job harder and directly influenced patient care. I always found it distasteful to hear, “Dr. X treats people very poorly, but he or she is such a great doctor.” Should not doctors be both excellent at their work and excel at the human relationship side of the business? Maybe we did need to work on certain things.

An early Cleveland Clinic initiative was to immerse every employee, including physicians, in a half-day appreciative-inquiry exercise. This entailed sitting around a table with other randomly selected caregivers—a nurse, valet, environmental service worker, administrator—and discussing various topics, such as our role in the organization, teamwork, and the servant-leader philosophy. Going into this exercise, I was skeptical. But going through it fostered a deeper understanding of how we all need to work better together to drive safe, high-quality patient care. It made me reflect on what patients go through every day and the critical contribution each team member makes. The program made me think about what we do and created greater appreciation and mindfulness of our work.

Think empathy

One of the most impactful efforts was getting people to understand and appreciate being on the other side of health care. The patient experience team crafted an empathy video that showcased people—patients, families, caregivers, physicians—and their thoughts as they experienced the other side of health care. The video frames what they are thinking about in the moment and is a powerful reminder that each person has something happening in their life that affects their daily experiences. The empathy video has been viewed by millions around the world. (See “Empathy: The human connection to patient care,” at https://www.youtube.com/watch?v=cDDWvj_q-o8.)

Together we embraced the work

Amy and I shared a unique perspective on this work as the leader of the experience improvement initiative, married to a person experiencing it. We both came to realize that we did not know all there is to know about how to deliver high-quality patient care. Improving experience is both complex and highly nuanced, and it is a vital component of what we do as physicians. The Clinic’s efforts moved the organization to high performance, and everyone played a role. However, we would not have succeeded without the engagement of physician leaders.

Making patients and families happy was never part of the equation. It is about reducing patient suffering and delivering safe, high-quality care in an environment where people feel cared for. That is what the people we serve desire, and it is what we want for ourselves. Although there will always be doubters, especially among physicians, of the importance of patient experience, we must never lose sight that this is the right thing to do for our patients, our families, and ourselves.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

My pager went off 20 minutes into my case. The circulating nurse announced that it was the chief of staff’s office, and as I migrated over to the phone, everyone was wondering what I had done to warrant a call from the boss. The nurse held the phone to my ear and Dr. Joe Hahn, a neurosurgeon and second-in-command at Cleveland Clinic, congratulated me: “You’re it,” he said. I thanked him and went back to work. My scrub tech wanted to know what happened. I told him I was just appointed chief experience officer at Cleveland Clinic. With a befuddled look, he asked what that meant. I said I wasn’t sure.

Jim gets a fast lesson on how to lead patient experience

Patient experience was a signature issue for Dr. Toby Cosgrove, our then president and chief executive officer. Although the Clinic was revered for its high-quality care, patients did not always like going there. Dr. Cosgrove passionately believed that providing a high-quality experience was as important as the best medical care, and that the experience at the Clinic needed to be improved. Another physician had held the role of chief experience officer before me, but she came from outside the system and was not practicing, which proved to be a challenge in the Clinic’s physician-dominated culture. Dr. Cosgrove wanted a physician who “grew up” in the organization to lead this initiative.

When I left my initial interview with Dr. Cosgrove, I could not define patient experience, did not know what HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) was—at the time were in the 10th percentile—and frankly had no idea how I would move a culture of 45,000 people, including 3,000 employed physicians, to embrace patient-centricity. By the time I left the Clinic in 2015, however, we had pushed our experience scores to the top quartile, realigned our culture, and had become world renown for patient experience.1

I knew intuitively that improving the patient experience was the right thing to do. In 2004, my father had died at the Clinic from surgical complications; his experience had been terrible. At that time, we did not use the term experience, but based on the items that hospitals are graded on today, my father would have failed us on all of them.

What is patient experience?

Patient experience is not about making people happy. Fundamentally, it is about delivering safe, high-quality, patient-centric care. A 2017 Press Ganey analysis of publicly reported data from the Centers for Medicaid and Medicare demonstrated that when performance on experience measures is high, safety and quality also are high.2 Similarly, in 2015, JAMA published an article using data from the National Surgical Quality Improvement Project demonstrating a significant association between patient experience scores and several objective measures of surgical quality, including mortality and complications.3

In my new role, I mercilessly told my father’s story, changed the narrative to include safety and quality, and asked my physician colleagues for their help to improve patient experience. People in health care pay very close attention to what physicians do and say, and I needed the doctors to “own it” if we were going to implement the desired change.

I also had to convince them to see themselves on the “other side.” It was not just a matter of “treating patients the way you would want to be treated.” It was about putting yourself in your patients’ shoes—having empathy for what they are experiencing and recognizing that you or a family member could be sitting in that bed. Before my father was ill, I had never been on the other side so intimately, and it was an eye-opening experience.

Retooling communication competency

For the physicians, we zeroed in on helping them improve how they communicate with patients. Communication is a high-value target for experience improvement, and it directly influences safety and quality. We produced a physician-centric communication guide that provided useful tips (see “Practical tips to help physicians improve communication with patients”). We made communication scores transparent. In addition, working with the American Academy on Communication in Healthcare (AACH), we developed a program specifically designed to help physicians improve their communication skills and practice management.4 The outcome was not only better scores but also higher physician engagement and lower burnout.5

Practical tips to help physicians improve communication with patients
  • Introduce yourself and your role
  • Address the patient by name and use common courtesy
  • Make nursing your partner
  • Ensure that the patient knows and understands the plan of care
  • Explain what the patient can expect (tests, procedures, consultations)
  • Address questions
  • Understand that house staff, care partners, and consultants impact your communication scores
  • Respect the patient's privacy
  • Be aware of what you do and say in front of patients
  • Include the patient's family when appropriate
  • Ask patients and visitors how they are being treated and if they need anything
  • Discuss pain management and set expectations
  • When necessary, apologize--try to right a wrong
  • Role model good behavior and address bad behavior

Keeping it real

Being married to another member of the medical staff—a strong-willed and opinionated one at that—ensured that my strategic approach to improving patient experience was grounded. It gave me a safe place to test ideas and concepts, which in turn allowed me to keep my instincts framed and relevant to the needs of key stakeholders, particularly the physicians.

Read what the ObGyn wife has to say.

 

 

The ObGyn wife tells her side

When my husband was appointed chief experience officer, I naturally was happy for his accomplishment but admitted that I was not sure exactly what it meant. What was he going to be doing? Would he give up surgery, which he loved?

The experience “thing” always had been fuzzy to me. I equated experience with satisfaction, and I saw my primary role as taking care of patients, not making them happy. I believed that I had great patient relationships, so what else did I need to know to contribute to this work? The connection to safety and quality did resonate with me, though, and it made talking about patient experience more tangible.

When Jim started teasing apart what steps needed to be taken, improving the culture seemed like an obvious focus. One thing was clear: He would need to get the physicians on board by helping them to see the practical importance of this work. It could not be gimmicky or too touchy-feely. The work had to be relevant and tangible to their everyday practice. One thing he said struck a chord: “Everyone comes to health care to help people, and we all believe we are the best we can be, but clearly there are opportunities to improve, and evolve our skills.” I started to consider specific circumstances in which that made sense.

Practice to be a better communicator

Improving physician communication was a top priority. I believed that I was a very good communicator, so I was not sure I would learn much from participating in a required day-long session designed by the AACH.

For this program we convened in small groups of 8 to 10 physicians, and each person paired with a partner. The course provided an important framework that would help us to better organize the patient encounter, an approach that no one had ever taught me. It showed me how to leverage the patient’s chief complaint to empower her to set the agenda. This would avoid unnecessary and inefficient conversational tangents, such as the doorknob question—when the patient brings up the real reason for the visit as you are leaving the exam room.

The course also taught me that while I was a good communicator, I was not efficient. I learned how to listen more effectively. Notably, how we manage patients and how we communicate are learned skills, just like mastering a new surgical procedure. High performance requires thoughtful review and practice.

Work on relationship skills

I had professional colleagues who were difficult to work with or, as I knew from covering for them, had terrible relationships with patients. These interactions made my job harder and directly influenced patient care. I always found it distasteful to hear, “Dr. X treats people very poorly, but he or she is such a great doctor.” Should not doctors be both excellent at their work and excel at the human relationship side of the business? Maybe we did need to work on certain things.

An early Cleveland Clinic initiative was to immerse every employee, including physicians, in a half-day appreciative-inquiry exercise. This entailed sitting around a table with other randomly selected caregivers—a nurse, valet, environmental service worker, administrator—and discussing various topics, such as our role in the organization, teamwork, and the servant-leader philosophy. Going into this exercise, I was skeptical. But going through it fostered a deeper understanding of how we all need to work better together to drive safe, high-quality patient care. It made me reflect on what patients go through every day and the critical contribution each team member makes. The program made me think about what we do and created greater appreciation and mindfulness of our work.

Think empathy

One of the most impactful efforts was getting people to understand and appreciate being on the other side of health care. The patient experience team crafted an empathy video that showcased people—patients, families, caregivers, physicians—and their thoughts as they experienced the other side of health care. The video frames what they are thinking about in the moment and is a powerful reminder that each person has something happening in their life that affects their daily experiences. The empathy video has been viewed by millions around the world. (See “Empathy: The human connection to patient care,” at https://www.youtube.com/watch?v=cDDWvj_q-o8.)

Together we embraced the work

Amy and I shared a unique perspective on this work as the leader of the experience improvement initiative, married to a person experiencing it. We both came to realize that we did not know all there is to know about how to deliver high-quality patient care. Improving experience is both complex and highly nuanced, and it is a vital component of what we do as physicians. The Clinic’s efforts moved the organization to high performance, and everyone played a role. However, we would not have succeeded without the engagement of physician leaders.

Making patients and families happy was never part of the equation. It is about reducing patient suffering and delivering safe, high-quality care in an environment where people feel cared for. That is what the people we serve desire, and it is what we want for ourselves. Although there will always be doubters, especially among physicians, of the importance of patient experience, we must never lose sight that this is the right thing to do for our patients, our families, and ourselves.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

References
  1. Merlino JI, Raman A. Health care's service fanatics: How the Cleveland Clinic leaped to the top of patient-satisfaction surveys. Harvard Business Review. 2013;91(5):108-116.
  2. Press Ganey 2016 Strategic Insights. Performance redefined: As healthcare moves from volume to value, the streams of quality are coming together. http://www.pressganey.com/resources/white-papers/2016-strategic-insights-performance-redefined. Published March 22, 2016. Accessed March 20, 2018.
  3. Sacks GD, Lawson EH, Dawes AJ, et al. Relationship between hospital performance on a patient satisfaction survey and surgical quality. JAMA Surg. 2015;150(9):858-864.
  4. Merlino JI, Coulton RW. Enhancing physician communication with patients at Cleveland Clinic. Group Practice J. 2012;61(2):24-32.
  5. Boissy A, Windover AK, Bokar D, et al. Communication skills training for physicians improves patient satisfaction. J Gen Intern Med. 2016;31(7):755-761.
References
  1. Merlino JI, Raman A. Health care's service fanatics: How the Cleveland Clinic leaped to the top of patient-satisfaction surveys. Harvard Business Review. 2013;91(5):108-116.
  2. Press Ganey 2016 Strategic Insights. Performance redefined: As healthcare moves from volume to value, the streams of quality are coming together. http://www.pressganey.com/resources/white-papers/2016-strategic-insights-performance-redefined. Published March 22, 2016. Accessed March 20, 2018.
  3. Sacks GD, Lawson EH, Dawes AJ, et al. Relationship between hospital performance on a patient satisfaction survey and surgical quality. JAMA Surg. 2015;150(9):858-864.
  4. Merlino JI, Coulton RW. Enhancing physician communication with patients at Cleveland Clinic. Group Practice J. 2012;61(2):24-32.
  5. Boissy A, Windover AK, Bokar D, et al. Communication skills training for physicians improves patient satisfaction. J Gen Intern Med. 2016;31(7):755-761.
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Preprint publishing challenges the status quo in medicine

@TheDoctorIsVin or: How I learned to start worrying and love @bioRxiv
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Like an upstart quick-draw challenging a grizzled gunslinger, preprint servers are muscling in on the once-exclusive territory of scientific journals.

These online venues sidestep the time-honored but lengthy peer-review process in favor of instant data dissemination. By directly posting unreviewed papers, authors escape the months-long drudgery of peer review, stake an immediate claim on new ideas, and connect instantly with like-minded scientists whose feedback can mold this new idea into a sound scientific contribution.

“The caveat, of course, is that it may be crap.”

That’s the unvarnished truth of preprint publishing, said John Inglis, PhD – and he should know. As the cofounder of Cold Spring Harbor Laboratory’s bioRxiv, the largest-to-date preprint server for the biological sciences, he gives equal billing to both the lofty and the low, and lets them soar or sink by their own merit.

And many of them do soar, Dr. Inglis said. Of the more than 20,000 papers published since bioRxiv’s modest beginning in 2013, slightly more than 60% have gone on to peer-reviewed publication. The four most prolific sources of bioRxiv preprints are the research powerhouses of Stanford, Cambridge, Oxford, and Harvard. The twitterverse is virtually awash with #bioRxiv tags, which alert bioRxiv’s 18,000 followers to new papers in any of 27 subject areas. “We gave up counting 2 years ago, when we reached 100,000,” Dr. Inglis said.

BioRxiv, pronounced “bioarchive,” may be the largest preprint server for the biological sciences, but it’s not the only one. The Center for Open Science has created a preprint server search engine, which lists 25 such servers, a number of them in the life sciences.

PeerJ Preprints also offers a home for unreviewed papers, accepting “drafts of an article, abstract, or poster that has not yet been peer reviewed for formal publication.” Authors can submit a draft, incomplete, or final version, which can be online within 24 hours.

 

 


The bioRxiv model is coming to medicine, too. A new preprint server – to be called medRxiv – is expected to launch later in 2018 and will accept a wide range of papers on health and medicine, including clinical trial results.

Photo by Gina Motisi, Cold Spring Harbor Laboratory
John Inglis, PhD, is a cofounder of bioRxiv, the largest preprint server for the biological sciences.

 

Brand new or rebrand?

Preprint – or at least the concept of it – is nothing new, Dr. Inglis said. It’s simply the extension into the digital space of something that has been happening for many decades in the physical space.

Scientists have always written drafts of their papers and sent them out to friends and colleagues for feedback before unveiling them publicly. In the early 1990s, UC Berkeley astrophysicist Joanne Cohn began emailing unreviewed physics papers to colleagues. Within a couple of years, physicist Paul Ginsparg, PhD, of Cornell University, created a central repository for these papers at the Los Alamos National Laboratory. This repository became aRxiv, a central component of communication in the physical sciences, and the progenitor of the preprint servers now in existence.

The biological sciences were far behind this curve of open sharing, Dr. Inglis said. “I think some biologists were always aware of aRxiv and intrigued by it, but most were unconvinced that the habits and behaviors of research biologists would support a similar process.”

 

 


The competition inherent in research biology was likely a large driver of that lag. “Biological experiments are complicated, it takes a long time for ideas to evolve and results to arrive, and people are possessive of their data and ideas. They have always shared information through conferences, but there was a lot of hesitation about making this information available in an uncontrolled way, beyond the audiences at those meetings,” he said.

[polldaddy:9970002]

Nature Publishing Group first floated the preprint notion among biologists in 2006, with Nature Precedings. It published more than 2,000 papers before folding, rather suddenly, in 2012. A publisher’s statement simply said that the effort was “unsustainable as originally conceived.”

Commentators suspected the model was a financial bust, and indeed, preprint servers aren’t money machines. BioRxiv, proudly not for profit, was founded with financial support from Cold Spring Harbor Laboratory and survives largely on private grants. In April 2017, it received a grant for an undisclosed amount from the Chan Zuckerberg Initiative, established by Facebook founder Mark Zuckerberg and his wife, Priscilla Chan.

 

 

Who’s minding the data?

The screening process at bioRxiv is minimal, Dr. Inglis said. An in-house staff checks each paper for obvious flaws, like plagiarism, irrelevance, unacceptable article type, and offensive language. Then they’re sent out to a committee of affiliate scientists, which confirms that the manuscript is a research paper and that it contains science, without judging the quality of that science. Papers aren’t edited before being posted online.

Each bioRxiv paper gets a DOI link, and appears with the following disclaimer detailing the risks inherent in reading “unrefereed” science: “Because [peer review] can be lengthy, authors use the bioRxiv service to make their manuscripts available as ‘preprints’ before peer review, allowing other scientists to see, discuss, and comment on the findings immediately. Readers should therefore be aware that articles on bioRxiv have not been finalized by authors, might contain errors, and report information that has not yet been accepted or endorsed in any way by the scientific or medical community.”
 

From biology to medicine

The bioRxiv team is poised to jump into a different pool now – medical science. Although the launch date isn’t firm yet, medRxiv will go live sometime very soon, Dr. Inglis said. It’s a proposed partnership between Cold Spring Harbor Laboratory, the Yale-based YODA Project (Yale University Open Data Access Project), and BMJ. The medRxiv papers, like those posted to bioRxiv, will be screened but not peer reviewed or scrutinized for trial design, methodology, or interpretation of results.

The benefits of medRxiv will be more rapid communication of research results, increased opportunities for collaboration, the sharing of hard-to-publish outputs like quality innovations in health care, and greater transparency of clinical trials data, Dr. Inglis said. Despite this, he expects the same kind of push-back bioRxiv initially encountered, at least in the beginning.

 

 


“I expect we will be turning the clock back 5 years and find a lot of people who think this is potentially a bad thing, a risk that poor information or misinformation is going to be disseminated to a wider audience, which is exactly what we heard about bioRxiv,” he said. “But we hope that when medRxiv launches, it will demonstrate the same kind of gradual acceptance as people get more and more familiar with the preprint platform.”

The founders intend to build into the server policies to mitigate the risk from medically relevant information that hasn’t been peer reviewed, such as not accepting case studies or editorials and opinion pieces, he added.

While many find the preprint disclaimer acceptable on papers that have no immediate clinical impact, there is concern about applying it to papers that discuss patient treatment.

Howard Bauchner, MD, JAMA’s editor in chief, addressed it in an editorial published in September 2017. Although not explicitly directed at bioRxiv, Dr. Bauchner took a firm stance against shortcutting the evaluation of evidence that is often years in the making.
 

 


“New interest in preprint servers in clinical medicine increases the likelihood of premature dissemination and public consumption of clinical research findings prior to rigorous evaluation and peer review,” Dr. Bauchner wrote. “For most articles, public consumption of research findings prior to peer review will have little influence on health, but for some articles, the effect could be devastating for some patients if the results made public prior to peer review are wrong or incorrectly interpreted.”

Dr. Bauchner did not overstate the potential influence of unvetted science, as a January 2018 bioRxiv study on CRISPR gene editing clearly demonstrated. The paper by Carsten Charlesworth, a doctoral student at Stanford (Calif.) University, found that up to 79% of humans could already be immune to Crispr-Cas9, the gene-editing protein derived from Staphylococcus aureus and S. pyogenes. More than science geeks were reading: The report initially sent CRISPR stocks tumbling.

Aaron D. Viny, MD, is in general a hesitant fan of bioRxiv’s preprint platform. But he raised an eyebrow when he learned about medRxiv.

“The only pressure that I can see in regulating these reports is social media,” said Dr. Viny, a hematologic oncologist at Memorial Sloan Kettering, in New York. “The fear is that it will be misused in two different realms. The most dangerous and worrisome, of course, is for patients using the data to influence their care plan, when the data haven’t been vetted appropriately. But secondarily, how could it influence the economics of clinical trials? There is no shortage of hedge fund managers in biotech. These data could misinform a consultant who might know the area in a way that artificially exploits early research data. Could that permit someone to submit disingenuous data to manipulate the stock of a given pharmaceutical company? I don’t know how you police that kind of thing.”
 

 

Who’s loving it – and why?

There are plenty of reasons to support a thriving preprint community, said Jessica Polka, PhD, director of ASAPbio, (Accelerating Science and Publication in biology), a group that bills itself as a scientist-driven initiative to promote the productive use of preprints in the life sciences.

“Preprinting complements traditional journal publishing by allowing researchers to rapidly communicate their findings to the scientific community,” she said. “This, in turn, provides them with opportunities for earlier and broader feedback and a way to transparently demonstrate progress on a project. More importantly, the whole community benefits by having earlier access to research findings, which can accelerate the pace of discovery.”

ASAPbio
Jessica Polka, PhD
Preprint-like data are already abundant anyway, in evidence at every scientific meeting, Dr. Polka said. “Late-breaking abstracts are of a similar status, except that the complete picture is not always fully available for everyone. A preprint would actually give you full disclosure of the methods and the analysis – way more information. On every level, these practices of sharing nonreviewed work are already in the system, and we accept them as provisional.”

The disclosures applied to every preprint paper are the publisher’s way of assuring this same awareness, she said. And preprints do need to be approached with some skepticism, as should peer-reviewed literature.

“The veracity of published papers is not always a given. An example is the 1998 vaccine paper [published in the Lancet] by Dr. Andrew Wakefield,” which launched the antivaccine movement. “But the answer to problems of reliability is to provide more information about the research and how it has been verified and evaluated, not less information. For example, confirmation bias can make it difficult to refute work that has been published. The current incentives for publishing negative results in a journal are not strong enough to reveal all of the information that could be useful to other researchers, but preprinting reduces the barrier to sharing negative results,” she said.
 

 

Swimming up the (main)stream

Universal peer-reviewed acceptance of preprints isn’t a done deal, Dr. Polka said. Journals are tussling with how to handle these papers. The Lancet clearly states that preprints don’t constitute prior publication and are welcome. The New England Journal of Medicine offers an uncontestable “no way.”

JAMA discourages submitting preprints, and will consider one only if the submitted version offers “meaningful new information” above what the preprint disseminated.

Cell Press has a slightly different take. They will consider papers previously posted on preprint services, but the policy applies only to the original submitted version of the paper. “We do not support posting of revisions that respond to editorial input and peer review or the final published version to preprint servers,” the policy notes.

In an interview, Deborah Sweet, PhD, the group’s vice president of editorial, elaborated on the policy. “In our view, one of the most important purposes of preprint posting is to gather feedback from the scientific community before a formal submission to a journal,” she said. “The ‘original submission’ term in our guidelines refers to the first version of the paper submitted to [Cell Press], which could include revisions made in response to community feedback on a preprint. After formal submission, we think it is most appropriate to incorporate and represent the value of the editorial and peer-review evaluation process in the final published journal article so that is clearly identifiable as the version of record.”

bioRxiv has made substantial inroads with dozens of other peer-reviewed journals. More than 100 – including a number of publications by EMBO Press and PLOS (Public Library of Science) – participate in bioRxiv’s B2J (BioRxiv-to-journal) direct-submission program.

With a few clicks, authors can transmit their bioRxiv manuscript files directly to these journals, without having to prepare separate submissions, Dr. Sweet said. Last year, Cell Press added two publications – Cell Reports and Structure – to the B2J program. “Once the paper is sent, it moves behind the scenes to the journal system and reappears as a formal submission,” she said. “In our process, before transferring the paper to the journal editors, authors have a chance to update the files (for example, to add a cover letter) and answer the standard questions that we ask, including ones about reviewer suggestions and exclusion requests. Once that step is done, the paper is handed over to the editorial team, and it’s ready to go for consideration in the same way as any other submission.”

 

 

Who’s reading?

Regardless of whether peer-review journals grant them legitimacy, preprints are getting a lot of views. A recent research letter, published in JAMA, looked at readership and online attention in 7,750 preprints posted from November 2013 to January 2017.

Primary author Stylianos Serghiou then selected 776 papers that had first appeared in bioRxiv, and matched them with 3,647 peer-reviewed articles lacking preprint exposure. He examined several publishing metrics for the papers, including views and downloads, citations in other sources, and Altmetric scores.

Altmetric tracks digital attention to scientific papers: Wikipedia citations, mentions in policy documents, blog discussions, and social media mentions including Facebook, Reddit, and Twitter. An Altmetric “attention score” of more than 20 corresponds to articles in the top 5% of readership, he said in an interview.

“Almost one in five of the bioRxiv preprints were getting these very high Almetric scores – much higher scores than articles that had no preprint posting,” Mr. Serghiou said in an interview.

Other findings include:

 

 

  • The median number of preprint abstract views was 924, and the median number of PDF downloads was 321.
  • In total, 18% of the preprints achieved an Altmetric score of more than 20.
  • Of 7,750 preprints, 55% were accepted in a peer-reviewed publication within 24 months.
  • Altmetric scores were significantly higher in articles in preprints (median 9.5 vs. 3.5).

The differences are probably related, at least in part, to the digital media savvy of preprint authors, Mr. Serghiou suggested. “We speculate that people who publish in bioRxiv may be more familiar with social media methods of making others aware of their work. They tend to be very good at using platforms like Twitter and Facebook to promote their results.”

Despite the high exposure scores, only 10% of bioRxiv articles get any posted comments or feedback – a key raison d’être for using a preprint service.

“Ten percent doesn’t sound like a very robust [feedback], but most journal articles get no comments whatsoever,” Dr. Inglis said. “And if they do, especially on the weekly magazines of science, comments may be from someone who has an ax to grind, or who doesn’t know much about the subject.”

What isn’t measured, in either volume or import, is the private communication a preprint engenders, Dr. Inglis said. “Feedback comes directly and privately to the author through email or at meetings or on the phone. We hear time and again that authors get hundreds of downloads after posting, and receive numerous contacts from colleagues who want to know more, to point out weaknesses, or request collaborations. These are the advantages we see from this potentially anxiety-provoking process of putting a manuscript out that has not been approved for publication. The entire purpose is to accelerate the speed of research by accelerating the speed of communication.”

Dr. Inglis, Dr. Sweet, and Dr. Polka are all employees of their respective companies. Dr. Viny and Mr. Serghiou both reported having no financial disclosures relevant to this article.

Body

 

It’s another beautiful day on the upper east side of Manhattan. The sun shines through the window shades, my 2-year-old daughter sings to herself as she wakes up, my wife has just returned from an early-morning workout – all is right as rain.

My phone buzzes. My stomach clenches. It buzzes again. My Twitter alerts are here. I dread this part of my morning ritual – finding out if I’ve been scooped overnight by the massive inflow of scientific manuscripts reported to me by my army of scientific literature–searching Twitter bots.

Dr. Aaron D. Viny
That’s right, Twitter isn’t just for presidents anymore, and in fact, the medical community has embraced Twitter across countless fields and disciplines. Scientific conferences now have their specific hashtags, so those of you who couldn’t come can follow along at home.

But this massive data dump now has a #fakenews problem. It’s not Russian election meddling, it’s open source “preprint” publications. Nearly half of my morning list of Twitter alerts now are sourced from the latest uploads to bioRxiv. BioRxiv is an online site run by scientists at Cold Spring Harbor Laboratory and is composed of posting manuscripts without undergoing a peer-review process. Now, most commonly, these manuscripts are concurrently under review in the bona fide peer-review process elsewhere, but unrevised, they are uploaded directly for public consumption.

There was one recent tweet that highlighted some interesting logistical considerations for bioRxiv manuscripts in the peer-review process. The tweet from an unnamed laboratory complains that a peer reviewer is displeased with the authors citing their own bioRxiv paper, while the tweeter contends that all referenced information, online or otherwise, must be cited. Moreover, the reviewer brings up an accusation of self-plagiarism as the submitted manuscript is identical to the one on bioRxiv. While the latter just seems like a misunderstanding of the bioRxiv platform, the former is a really interesting question of whether bioRxiv represents data that can/should be referenced.

Proponents of the platform are excited that data is accessible sooner, that one’s latest and greatest scientific finding can be “scoop proof” by getting it online and marking one’s territory. Naysayers contend that, without peer review, the work cannot truly be part of the scientific literature and should be taken with great caution.

There is undoubtedly danger. Online media sources Gizmodo and the Motley Fool both reported that a January 2018 bioRxiv preprint resulted in a nearly 20% drop in stock prices of CRISPR biotechnology firms Editas Medicine and Intellia Therapeutics. The manuscript warned of the potential immunogenicity of CRISPR, suggesting that preexisting antibodies might limit its clinical application. Far more cynically, this highlights how a stock price could theoretically be artificially manipulated through preprint data.

The preprint is an open market response to the long, arduous process that peer review has become, but undoubtedly, peer review is an essential part of how we maintain transparency and accountability in science and medicine. It remains to be seen exactly how journal editors intend to use bioRxiv submissions in the appraisal of “novelty.”

How will the scientific community vet and referee the works, and will the title and conclusions of a scientifically flawed work permeate misleading information into the field and lay public? Would you let it influence your research or clinical practice? We will be finding out one tweet at a time.

Aaron D. Viny, MD, is with the Memorial Sloan Kettering Cancer Center, N.Y., where he is a clinical instructor, is on the staff of the leukemia service, and is a clinical researcher in the Ross Levine Lab. He reported having no relevant financial disclosures. Contact him on Twitter @TheDoctorIsVin​.

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Body

 

It’s another beautiful day on the upper east side of Manhattan. The sun shines through the window shades, my 2-year-old daughter sings to herself as she wakes up, my wife has just returned from an early-morning workout – all is right as rain.

My phone buzzes. My stomach clenches. It buzzes again. My Twitter alerts are here. I dread this part of my morning ritual – finding out if I’ve been scooped overnight by the massive inflow of scientific manuscripts reported to me by my army of scientific literature–searching Twitter bots.

Dr. Aaron D. Viny
That’s right, Twitter isn’t just for presidents anymore, and in fact, the medical community has embraced Twitter across countless fields and disciplines. Scientific conferences now have their specific hashtags, so those of you who couldn’t come can follow along at home.

But this massive data dump now has a #fakenews problem. It’s not Russian election meddling, it’s open source “preprint” publications. Nearly half of my morning list of Twitter alerts now are sourced from the latest uploads to bioRxiv. BioRxiv is an online site run by scientists at Cold Spring Harbor Laboratory and is composed of posting manuscripts without undergoing a peer-review process. Now, most commonly, these manuscripts are concurrently under review in the bona fide peer-review process elsewhere, but unrevised, they are uploaded directly for public consumption.

There was one recent tweet that highlighted some interesting logistical considerations for bioRxiv manuscripts in the peer-review process. The tweet from an unnamed laboratory complains that a peer reviewer is displeased with the authors citing their own bioRxiv paper, while the tweeter contends that all referenced information, online or otherwise, must be cited. Moreover, the reviewer brings up an accusation of self-plagiarism as the submitted manuscript is identical to the one on bioRxiv. While the latter just seems like a misunderstanding of the bioRxiv platform, the former is a really interesting question of whether bioRxiv represents data that can/should be referenced.

Proponents of the platform are excited that data is accessible sooner, that one’s latest and greatest scientific finding can be “scoop proof” by getting it online and marking one’s territory. Naysayers contend that, without peer review, the work cannot truly be part of the scientific literature and should be taken with great caution.

There is undoubtedly danger. Online media sources Gizmodo and the Motley Fool both reported that a January 2018 bioRxiv preprint resulted in a nearly 20% drop in stock prices of CRISPR biotechnology firms Editas Medicine and Intellia Therapeutics. The manuscript warned of the potential immunogenicity of CRISPR, suggesting that preexisting antibodies might limit its clinical application. Far more cynically, this highlights how a stock price could theoretically be artificially manipulated through preprint data.

The preprint is an open market response to the long, arduous process that peer review has become, but undoubtedly, peer review is an essential part of how we maintain transparency and accountability in science and medicine. It remains to be seen exactly how journal editors intend to use bioRxiv submissions in the appraisal of “novelty.”

How will the scientific community vet and referee the works, and will the title and conclusions of a scientifically flawed work permeate misleading information into the field and lay public? Would you let it influence your research or clinical practice? We will be finding out one tweet at a time.

Aaron D. Viny, MD, is with the Memorial Sloan Kettering Cancer Center, N.Y., where he is a clinical instructor, is on the staff of the leukemia service, and is a clinical researcher in the Ross Levine Lab. He reported having no relevant financial disclosures. Contact him on Twitter @TheDoctorIsVin​.

Body

 

It’s another beautiful day on the upper east side of Manhattan. The sun shines through the window shades, my 2-year-old daughter sings to herself as she wakes up, my wife has just returned from an early-morning workout – all is right as rain.

My phone buzzes. My stomach clenches. It buzzes again. My Twitter alerts are here. I dread this part of my morning ritual – finding out if I’ve been scooped overnight by the massive inflow of scientific manuscripts reported to me by my army of scientific literature–searching Twitter bots.

Dr. Aaron D. Viny
That’s right, Twitter isn’t just for presidents anymore, and in fact, the medical community has embraced Twitter across countless fields and disciplines. Scientific conferences now have their specific hashtags, so those of you who couldn’t come can follow along at home.

But this massive data dump now has a #fakenews problem. It’s not Russian election meddling, it’s open source “preprint” publications. Nearly half of my morning list of Twitter alerts now are sourced from the latest uploads to bioRxiv. BioRxiv is an online site run by scientists at Cold Spring Harbor Laboratory and is composed of posting manuscripts without undergoing a peer-review process. Now, most commonly, these manuscripts are concurrently under review in the bona fide peer-review process elsewhere, but unrevised, they are uploaded directly for public consumption.

There was one recent tweet that highlighted some interesting logistical considerations for bioRxiv manuscripts in the peer-review process. The tweet from an unnamed laboratory complains that a peer reviewer is displeased with the authors citing their own bioRxiv paper, while the tweeter contends that all referenced information, online or otherwise, must be cited. Moreover, the reviewer brings up an accusation of self-plagiarism as the submitted manuscript is identical to the one on bioRxiv. While the latter just seems like a misunderstanding of the bioRxiv platform, the former is a really interesting question of whether bioRxiv represents data that can/should be referenced.

Proponents of the platform are excited that data is accessible sooner, that one’s latest and greatest scientific finding can be “scoop proof” by getting it online and marking one’s territory. Naysayers contend that, without peer review, the work cannot truly be part of the scientific literature and should be taken with great caution.

There is undoubtedly danger. Online media sources Gizmodo and the Motley Fool both reported that a January 2018 bioRxiv preprint resulted in a nearly 20% drop in stock prices of CRISPR biotechnology firms Editas Medicine and Intellia Therapeutics. The manuscript warned of the potential immunogenicity of CRISPR, suggesting that preexisting antibodies might limit its clinical application. Far more cynically, this highlights how a stock price could theoretically be artificially manipulated through preprint data.

The preprint is an open market response to the long, arduous process that peer review has become, but undoubtedly, peer review is an essential part of how we maintain transparency and accountability in science and medicine. It remains to be seen exactly how journal editors intend to use bioRxiv submissions in the appraisal of “novelty.”

How will the scientific community vet and referee the works, and will the title and conclusions of a scientifically flawed work permeate misleading information into the field and lay public? Would you let it influence your research or clinical practice? We will be finding out one tweet at a time.

Aaron D. Viny, MD, is with the Memorial Sloan Kettering Cancer Center, N.Y., where he is a clinical instructor, is on the staff of the leukemia service, and is a clinical researcher in the Ross Levine Lab. He reported having no relevant financial disclosures. Contact him on Twitter @TheDoctorIsVin​.

Title
@TheDoctorIsVin or: How I learned to start worrying and love @bioRxiv
@TheDoctorIsVin or: How I learned to start worrying and love @bioRxiv

 

Like an upstart quick-draw challenging a grizzled gunslinger, preprint servers are muscling in on the once-exclusive territory of scientific journals.

These online venues sidestep the time-honored but lengthy peer-review process in favor of instant data dissemination. By directly posting unreviewed papers, authors escape the months-long drudgery of peer review, stake an immediate claim on new ideas, and connect instantly with like-minded scientists whose feedback can mold this new idea into a sound scientific contribution.

“The caveat, of course, is that it may be crap.”

That’s the unvarnished truth of preprint publishing, said John Inglis, PhD – and he should know. As the cofounder of Cold Spring Harbor Laboratory’s bioRxiv, the largest-to-date preprint server for the biological sciences, he gives equal billing to both the lofty and the low, and lets them soar or sink by their own merit.

And many of them do soar, Dr. Inglis said. Of the more than 20,000 papers published since bioRxiv’s modest beginning in 2013, slightly more than 60% have gone on to peer-reviewed publication. The four most prolific sources of bioRxiv preprints are the research powerhouses of Stanford, Cambridge, Oxford, and Harvard. The twitterverse is virtually awash with #bioRxiv tags, which alert bioRxiv’s 18,000 followers to new papers in any of 27 subject areas. “We gave up counting 2 years ago, when we reached 100,000,” Dr. Inglis said.

BioRxiv, pronounced “bioarchive,” may be the largest preprint server for the biological sciences, but it’s not the only one. The Center for Open Science has created a preprint server search engine, which lists 25 such servers, a number of them in the life sciences.

PeerJ Preprints also offers a home for unreviewed papers, accepting “drafts of an article, abstract, or poster that has not yet been peer reviewed for formal publication.” Authors can submit a draft, incomplete, or final version, which can be online within 24 hours.

 

 


The bioRxiv model is coming to medicine, too. A new preprint server – to be called medRxiv – is expected to launch later in 2018 and will accept a wide range of papers on health and medicine, including clinical trial results.

Photo by Gina Motisi, Cold Spring Harbor Laboratory
John Inglis, PhD, is a cofounder of bioRxiv, the largest preprint server for the biological sciences.

 

Brand new or rebrand?

Preprint – or at least the concept of it – is nothing new, Dr. Inglis said. It’s simply the extension into the digital space of something that has been happening for many decades in the physical space.

Scientists have always written drafts of their papers and sent them out to friends and colleagues for feedback before unveiling them publicly. In the early 1990s, UC Berkeley astrophysicist Joanne Cohn began emailing unreviewed physics papers to colleagues. Within a couple of years, physicist Paul Ginsparg, PhD, of Cornell University, created a central repository for these papers at the Los Alamos National Laboratory. This repository became aRxiv, a central component of communication in the physical sciences, and the progenitor of the preprint servers now in existence.

The biological sciences were far behind this curve of open sharing, Dr. Inglis said. “I think some biologists were always aware of aRxiv and intrigued by it, but most were unconvinced that the habits and behaviors of research biologists would support a similar process.”

 

 


The competition inherent in research biology was likely a large driver of that lag. “Biological experiments are complicated, it takes a long time for ideas to evolve and results to arrive, and people are possessive of their data and ideas. They have always shared information through conferences, but there was a lot of hesitation about making this information available in an uncontrolled way, beyond the audiences at those meetings,” he said.

[polldaddy:9970002]

Nature Publishing Group first floated the preprint notion among biologists in 2006, with Nature Precedings. It published more than 2,000 papers before folding, rather suddenly, in 2012. A publisher’s statement simply said that the effort was “unsustainable as originally conceived.”

Commentators suspected the model was a financial bust, and indeed, preprint servers aren’t money machines. BioRxiv, proudly not for profit, was founded with financial support from Cold Spring Harbor Laboratory and survives largely on private grants. In April 2017, it received a grant for an undisclosed amount from the Chan Zuckerberg Initiative, established by Facebook founder Mark Zuckerberg and his wife, Priscilla Chan.

 

 

Who’s minding the data?

The screening process at bioRxiv is minimal, Dr. Inglis said. An in-house staff checks each paper for obvious flaws, like plagiarism, irrelevance, unacceptable article type, and offensive language. Then they’re sent out to a committee of affiliate scientists, which confirms that the manuscript is a research paper and that it contains science, without judging the quality of that science. Papers aren’t edited before being posted online.

Each bioRxiv paper gets a DOI link, and appears with the following disclaimer detailing the risks inherent in reading “unrefereed” science: “Because [peer review] can be lengthy, authors use the bioRxiv service to make their manuscripts available as ‘preprints’ before peer review, allowing other scientists to see, discuss, and comment on the findings immediately. Readers should therefore be aware that articles on bioRxiv have not been finalized by authors, might contain errors, and report information that has not yet been accepted or endorsed in any way by the scientific or medical community.”
 

From biology to medicine

The bioRxiv team is poised to jump into a different pool now – medical science. Although the launch date isn’t firm yet, medRxiv will go live sometime very soon, Dr. Inglis said. It’s a proposed partnership between Cold Spring Harbor Laboratory, the Yale-based YODA Project (Yale University Open Data Access Project), and BMJ. The medRxiv papers, like those posted to bioRxiv, will be screened but not peer reviewed or scrutinized for trial design, methodology, or interpretation of results.

The benefits of medRxiv will be more rapid communication of research results, increased opportunities for collaboration, the sharing of hard-to-publish outputs like quality innovations in health care, and greater transparency of clinical trials data, Dr. Inglis said. Despite this, he expects the same kind of push-back bioRxiv initially encountered, at least in the beginning.

 

 


“I expect we will be turning the clock back 5 years and find a lot of people who think this is potentially a bad thing, a risk that poor information or misinformation is going to be disseminated to a wider audience, which is exactly what we heard about bioRxiv,” he said. “But we hope that when medRxiv launches, it will demonstrate the same kind of gradual acceptance as people get more and more familiar with the preprint platform.”

The founders intend to build into the server policies to mitigate the risk from medically relevant information that hasn’t been peer reviewed, such as not accepting case studies or editorials and opinion pieces, he added.

While many find the preprint disclaimer acceptable on papers that have no immediate clinical impact, there is concern about applying it to papers that discuss patient treatment.

Howard Bauchner, MD, JAMA’s editor in chief, addressed it in an editorial published in September 2017. Although not explicitly directed at bioRxiv, Dr. Bauchner took a firm stance against shortcutting the evaluation of evidence that is often years in the making.
 

 


“New interest in preprint servers in clinical medicine increases the likelihood of premature dissemination and public consumption of clinical research findings prior to rigorous evaluation and peer review,” Dr. Bauchner wrote. “For most articles, public consumption of research findings prior to peer review will have little influence on health, but for some articles, the effect could be devastating for some patients if the results made public prior to peer review are wrong or incorrectly interpreted.”

Dr. Bauchner did not overstate the potential influence of unvetted science, as a January 2018 bioRxiv study on CRISPR gene editing clearly demonstrated. The paper by Carsten Charlesworth, a doctoral student at Stanford (Calif.) University, found that up to 79% of humans could already be immune to Crispr-Cas9, the gene-editing protein derived from Staphylococcus aureus and S. pyogenes. More than science geeks were reading: The report initially sent CRISPR stocks tumbling.

Aaron D. Viny, MD, is in general a hesitant fan of bioRxiv’s preprint platform. But he raised an eyebrow when he learned about medRxiv.

“The only pressure that I can see in regulating these reports is social media,” said Dr. Viny, a hematologic oncologist at Memorial Sloan Kettering, in New York. “The fear is that it will be misused in two different realms. The most dangerous and worrisome, of course, is for patients using the data to influence their care plan, when the data haven’t been vetted appropriately. But secondarily, how could it influence the economics of clinical trials? There is no shortage of hedge fund managers in biotech. These data could misinform a consultant who might know the area in a way that artificially exploits early research data. Could that permit someone to submit disingenuous data to manipulate the stock of a given pharmaceutical company? I don’t know how you police that kind of thing.”
 

 

Who’s loving it – and why?

There are plenty of reasons to support a thriving preprint community, said Jessica Polka, PhD, director of ASAPbio, (Accelerating Science and Publication in biology), a group that bills itself as a scientist-driven initiative to promote the productive use of preprints in the life sciences.

“Preprinting complements traditional journal publishing by allowing researchers to rapidly communicate their findings to the scientific community,” she said. “This, in turn, provides them with opportunities for earlier and broader feedback and a way to transparently demonstrate progress on a project. More importantly, the whole community benefits by having earlier access to research findings, which can accelerate the pace of discovery.”

ASAPbio
Jessica Polka, PhD
Preprint-like data are already abundant anyway, in evidence at every scientific meeting, Dr. Polka said. “Late-breaking abstracts are of a similar status, except that the complete picture is not always fully available for everyone. A preprint would actually give you full disclosure of the methods and the analysis – way more information. On every level, these practices of sharing nonreviewed work are already in the system, and we accept them as provisional.”

The disclosures applied to every preprint paper are the publisher’s way of assuring this same awareness, she said. And preprints do need to be approached with some skepticism, as should peer-reviewed literature.

“The veracity of published papers is not always a given. An example is the 1998 vaccine paper [published in the Lancet] by Dr. Andrew Wakefield,” which launched the antivaccine movement. “But the answer to problems of reliability is to provide more information about the research and how it has been verified and evaluated, not less information. For example, confirmation bias can make it difficult to refute work that has been published. The current incentives for publishing negative results in a journal are not strong enough to reveal all of the information that could be useful to other researchers, but preprinting reduces the barrier to sharing negative results,” she said.
 

 

Swimming up the (main)stream

Universal peer-reviewed acceptance of preprints isn’t a done deal, Dr. Polka said. Journals are tussling with how to handle these papers. The Lancet clearly states that preprints don’t constitute prior publication and are welcome. The New England Journal of Medicine offers an uncontestable “no way.”

JAMA discourages submitting preprints, and will consider one only if the submitted version offers “meaningful new information” above what the preprint disseminated.

Cell Press has a slightly different take. They will consider papers previously posted on preprint services, but the policy applies only to the original submitted version of the paper. “We do not support posting of revisions that respond to editorial input and peer review or the final published version to preprint servers,” the policy notes.

In an interview, Deborah Sweet, PhD, the group’s vice president of editorial, elaborated on the policy. “In our view, one of the most important purposes of preprint posting is to gather feedback from the scientific community before a formal submission to a journal,” she said. “The ‘original submission’ term in our guidelines refers to the first version of the paper submitted to [Cell Press], which could include revisions made in response to community feedback on a preprint. After formal submission, we think it is most appropriate to incorporate and represent the value of the editorial and peer-review evaluation process in the final published journal article so that is clearly identifiable as the version of record.”

bioRxiv has made substantial inroads with dozens of other peer-reviewed journals. More than 100 – including a number of publications by EMBO Press and PLOS (Public Library of Science) – participate in bioRxiv’s B2J (BioRxiv-to-journal) direct-submission program.

With a few clicks, authors can transmit their bioRxiv manuscript files directly to these journals, without having to prepare separate submissions, Dr. Sweet said. Last year, Cell Press added two publications – Cell Reports and Structure – to the B2J program. “Once the paper is sent, it moves behind the scenes to the journal system and reappears as a formal submission,” she said. “In our process, before transferring the paper to the journal editors, authors have a chance to update the files (for example, to add a cover letter) and answer the standard questions that we ask, including ones about reviewer suggestions and exclusion requests. Once that step is done, the paper is handed over to the editorial team, and it’s ready to go for consideration in the same way as any other submission.”

 

 

Who’s reading?

Regardless of whether peer-review journals grant them legitimacy, preprints are getting a lot of views. A recent research letter, published in JAMA, looked at readership and online attention in 7,750 preprints posted from November 2013 to January 2017.

Primary author Stylianos Serghiou then selected 776 papers that had first appeared in bioRxiv, and matched them with 3,647 peer-reviewed articles lacking preprint exposure. He examined several publishing metrics for the papers, including views and downloads, citations in other sources, and Altmetric scores.

Altmetric tracks digital attention to scientific papers: Wikipedia citations, mentions in policy documents, blog discussions, and social media mentions including Facebook, Reddit, and Twitter. An Altmetric “attention score” of more than 20 corresponds to articles in the top 5% of readership, he said in an interview.

“Almost one in five of the bioRxiv preprints were getting these very high Almetric scores – much higher scores than articles that had no preprint posting,” Mr. Serghiou said in an interview.

Other findings include:

 

 

  • The median number of preprint abstract views was 924, and the median number of PDF downloads was 321.
  • In total, 18% of the preprints achieved an Altmetric score of more than 20.
  • Of 7,750 preprints, 55% were accepted in a peer-reviewed publication within 24 months.
  • Altmetric scores were significantly higher in articles in preprints (median 9.5 vs. 3.5).

The differences are probably related, at least in part, to the digital media savvy of preprint authors, Mr. Serghiou suggested. “We speculate that people who publish in bioRxiv may be more familiar with social media methods of making others aware of their work. They tend to be very good at using platforms like Twitter and Facebook to promote their results.”

Despite the high exposure scores, only 10% of bioRxiv articles get any posted comments or feedback – a key raison d’être for using a preprint service.

“Ten percent doesn’t sound like a very robust [feedback], but most journal articles get no comments whatsoever,” Dr. Inglis said. “And if they do, especially on the weekly magazines of science, comments may be from someone who has an ax to grind, or who doesn’t know much about the subject.”

What isn’t measured, in either volume or import, is the private communication a preprint engenders, Dr. Inglis said. “Feedback comes directly and privately to the author through email or at meetings or on the phone. We hear time and again that authors get hundreds of downloads after posting, and receive numerous contacts from colleagues who want to know more, to point out weaknesses, or request collaborations. These are the advantages we see from this potentially anxiety-provoking process of putting a manuscript out that has not been approved for publication. The entire purpose is to accelerate the speed of research by accelerating the speed of communication.”

Dr. Inglis, Dr. Sweet, and Dr. Polka are all employees of their respective companies. Dr. Viny and Mr. Serghiou both reported having no financial disclosures relevant to this article.

 

Like an upstart quick-draw challenging a grizzled gunslinger, preprint servers are muscling in on the once-exclusive territory of scientific journals.

These online venues sidestep the time-honored but lengthy peer-review process in favor of instant data dissemination. By directly posting unreviewed papers, authors escape the months-long drudgery of peer review, stake an immediate claim on new ideas, and connect instantly with like-minded scientists whose feedback can mold this new idea into a sound scientific contribution.

“The caveat, of course, is that it may be crap.”

That’s the unvarnished truth of preprint publishing, said John Inglis, PhD – and he should know. As the cofounder of Cold Spring Harbor Laboratory’s bioRxiv, the largest-to-date preprint server for the biological sciences, he gives equal billing to both the lofty and the low, and lets them soar or sink by their own merit.

And many of them do soar, Dr. Inglis said. Of the more than 20,000 papers published since bioRxiv’s modest beginning in 2013, slightly more than 60% have gone on to peer-reviewed publication. The four most prolific sources of bioRxiv preprints are the research powerhouses of Stanford, Cambridge, Oxford, and Harvard. The twitterverse is virtually awash with #bioRxiv tags, which alert bioRxiv’s 18,000 followers to new papers in any of 27 subject areas. “We gave up counting 2 years ago, when we reached 100,000,” Dr. Inglis said.

BioRxiv, pronounced “bioarchive,” may be the largest preprint server for the biological sciences, but it’s not the only one. The Center for Open Science has created a preprint server search engine, which lists 25 such servers, a number of them in the life sciences.

PeerJ Preprints also offers a home for unreviewed papers, accepting “drafts of an article, abstract, or poster that has not yet been peer reviewed for formal publication.” Authors can submit a draft, incomplete, or final version, which can be online within 24 hours.

 

 


The bioRxiv model is coming to medicine, too. A new preprint server – to be called medRxiv – is expected to launch later in 2018 and will accept a wide range of papers on health and medicine, including clinical trial results.

Photo by Gina Motisi, Cold Spring Harbor Laboratory
John Inglis, PhD, is a cofounder of bioRxiv, the largest preprint server for the biological sciences.

 

Brand new or rebrand?

Preprint – or at least the concept of it – is nothing new, Dr. Inglis said. It’s simply the extension into the digital space of something that has been happening for many decades in the physical space.

Scientists have always written drafts of their papers and sent them out to friends and colleagues for feedback before unveiling them publicly. In the early 1990s, UC Berkeley astrophysicist Joanne Cohn began emailing unreviewed physics papers to colleagues. Within a couple of years, physicist Paul Ginsparg, PhD, of Cornell University, created a central repository for these papers at the Los Alamos National Laboratory. This repository became aRxiv, a central component of communication in the physical sciences, and the progenitor of the preprint servers now in existence.

The biological sciences were far behind this curve of open sharing, Dr. Inglis said. “I think some biologists were always aware of aRxiv and intrigued by it, but most were unconvinced that the habits and behaviors of research biologists would support a similar process.”

 

 


The competition inherent in research biology was likely a large driver of that lag. “Biological experiments are complicated, it takes a long time for ideas to evolve and results to arrive, and people are possessive of their data and ideas. They have always shared information through conferences, but there was a lot of hesitation about making this information available in an uncontrolled way, beyond the audiences at those meetings,” he said.

[polldaddy:9970002]

Nature Publishing Group first floated the preprint notion among biologists in 2006, with Nature Precedings. It published more than 2,000 papers before folding, rather suddenly, in 2012. A publisher’s statement simply said that the effort was “unsustainable as originally conceived.”

Commentators suspected the model was a financial bust, and indeed, preprint servers aren’t money machines. BioRxiv, proudly not for profit, was founded with financial support from Cold Spring Harbor Laboratory and survives largely on private grants. In April 2017, it received a grant for an undisclosed amount from the Chan Zuckerberg Initiative, established by Facebook founder Mark Zuckerberg and his wife, Priscilla Chan.

 

 

Who’s minding the data?

The screening process at bioRxiv is minimal, Dr. Inglis said. An in-house staff checks each paper for obvious flaws, like plagiarism, irrelevance, unacceptable article type, and offensive language. Then they’re sent out to a committee of affiliate scientists, which confirms that the manuscript is a research paper and that it contains science, without judging the quality of that science. Papers aren’t edited before being posted online.

Each bioRxiv paper gets a DOI link, and appears with the following disclaimer detailing the risks inherent in reading “unrefereed” science: “Because [peer review] can be lengthy, authors use the bioRxiv service to make their manuscripts available as ‘preprints’ before peer review, allowing other scientists to see, discuss, and comment on the findings immediately. Readers should therefore be aware that articles on bioRxiv have not been finalized by authors, might contain errors, and report information that has not yet been accepted or endorsed in any way by the scientific or medical community.”
 

From biology to medicine

The bioRxiv team is poised to jump into a different pool now – medical science. Although the launch date isn’t firm yet, medRxiv will go live sometime very soon, Dr. Inglis said. It’s a proposed partnership between Cold Spring Harbor Laboratory, the Yale-based YODA Project (Yale University Open Data Access Project), and BMJ. The medRxiv papers, like those posted to bioRxiv, will be screened but not peer reviewed or scrutinized for trial design, methodology, or interpretation of results.

The benefits of medRxiv will be more rapid communication of research results, increased opportunities for collaboration, the sharing of hard-to-publish outputs like quality innovations in health care, and greater transparency of clinical trials data, Dr. Inglis said. Despite this, he expects the same kind of push-back bioRxiv initially encountered, at least in the beginning.

 

 


“I expect we will be turning the clock back 5 years and find a lot of people who think this is potentially a bad thing, a risk that poor information or misinformation is going to be disseminated to a wider audience, which is exactly what we heard about bioRxiv,” he said. “But we hope that when medRxiv launches, it will demonstrate the same kind of gradual acceptance as people get more and more familiar with the preprint platform.”

The founders intend to build into the server policies to mitigate the risk from medically relevant information that hasn’t been peer reviewed, such as not accepting case studies or editorials and opinion pieces, he added.

While many find the preprint disclaimer acceptable on papers that have no immediate clinical impact, there is concern about applying it to papers that discuss patient treatment.

Howard Bauchner, MD, JAMA’s editor in chief, addressed it in an editorial published in September 2017. Although not explicitly directed at bioRxiv, Dr. Bauchner took a firm stance against shortcutting the evaluation of evidence that is often years in the making.
 

 


“New interest in preprint servers in clinical medicine increases the likelihood of premature dissemination and public consumption of clinical research findings prior to rigorous evaluation and peer review,” Dr. Bauchner wrote. “For most articles, public consumption of research findings prior to peer review will have little influence on health, but for some articles, the effect could be devastating for some patients if the results made public prior to peer review are wrong or incorrectly interpreted.”

Dr. Bauchner did not overstate the potential influence of unvetted science, as a January 2018 bioRxiv study on CRISPR gene editing clearly demonstrated. The paper by Carsten Charlesworth, a doctoral student at Stanford (Calif.) University, found that up to 79% of humans could already be immune to Crispr-Cas9, the gene-editing protein derived from Staphylococcus aureus and S. pyogenes. More than science geeks were reading: The report initially sent CRISPR stocks tumbling.

Aaron D. Viny, MD, is in general a hesitant fan of bioRxiv’s preprint platform. But he raised an eyebrow when he learned about medRxiv.

“The only pressure that I can see in regulating these reports is social media,” said Dr. Viny, a hematologic oncologist at Memorial Sloan Kettering, in New York. “The fear is that it will be misused in two different realms. The most dangerous and worrisome, of course, is for patients using the data to influence their care plan, when the data haven’t been vetted appropriately. But secondarily, how could it influence the economics of clinical trials? There is no shortage of hedge fund managers in biotech. These data could misinform a consultant who might know the area in a way that artificially exploits early research data. Could that permit someone to submit disingenuous data to manipulate the stock of a given pharmaceutical company? I don’t know how you police that kind of thing.”
 

 

Who’s loving it – and why?

There are plenty of reasons to support a thriving preprint community, said Jessica Polka, PhD, director of ASAPbio, (Accelerating Science and Publication in biology), a group that bills itself as a scientist-driven initiative to promote the productive use of preprints in the life sciences.

“Preprinting complements traditional journal publishing by allowing researchers to rapidly communicate their findings to the scientific community,” she said. “This, in turn, provides them with opportunities for earlier and broader feedback and a way to transparently demonstrate progress on a project. More importantly, the whole community benefits by having earlier access to research findings, which can accelerate the pace of discovery.”

ASAPbio
Jessica Polka, PhD
Preprint-like data are already abundant anyway, in evidence at every scientific meeting, Dr. Polka said. “Late-breaking abstracts are of a similar status, except that the complete picture is not always fully available for everyone. A preprint would actually give you full disclosure of the methods and the analysis – way more information. On every level, these practices of sharing nonreviewed work are already in the system, and we accept them as provisional.”

The disclosures applied to every preprint paper are the publisher’s way of assuring this same awareness, she said. And preprints do need to be approached with some skepticism, as should peer-reviewed literature.

“The veracity of published papers is not always a given. An example is the 1998 vaccine paper [published in the Lancet] by Dr. Andrew Wakefield,” which launched the antivaccine movement. “But the answer to problems of reliability is to provide more information about the research and how it has been verified and evaluated, not less information. For example, confirmation bias can make it difficult to refute work that has been published. The current incentives for publishing negative results in a journal are not strong enough to reveal all of the information that could be useful to other researchers, but preprinting reduces the barrier to sharing negative results,” she said.
 

 

Swimming up the (main)stream

Universal peer-reviewed acceptance of preprints isn’t a done deal, Dr. Polka said. Journals are tussling with how to handle these papers. The Lancet clearly states that preprints don’t constitute prior publication and are welcome. The New England Journal of Medicine offers an uncontestable “no way.”

JAMA discourages submitting preprints, and will consider one only if the submitted version offers “meaningful new information” above what the preprint disseminated.

Cell Press has a slightly different take. They will consider papers previously posted on preprint services, but the policy applies only to the original submitted version of the paper. “We do not support posting of revisions that respond to editorial input and peer review or the final published version to preprint servers,” the policy notes.

In an interview, Deborah Sweet, PhD, the group’s vice president of editorial, elaborated on the policy. “In our view, one of the most important purposes of preprint posting is to gather feedback from the scientific community before a formal submission to a journal,” she said. “The ‘original submission’ term in our guidelines refers to the first version of the paper submitted to [Cell Press], which could include revisions made in response to community feedback on a preprint. After formal submission, we think it is most appropriate to incorporate and represent the value of the editorial and peer-review evaluation process in the final published journal article so that is clearly identifiable as the version of record.”

bioRxiv has made substantial inroads with dozens of other peer-reviewed journals. More than 100 – including a number of publications by EMBO Press and PLOS (Public Library of Science) – participate in bioRxiv’s B2J (BioRxiv-to-journal) direct-submission program.

With a few clicks, authors can transmit their bioRxiv manuscript files directly to these journals, without having to prepare separate submissions, Dr. Sweet said. Last year, Cell Press added two publications – Cell Reports and Structure – to the B2J program. “Once the paper is sent, it moves behind the scenes to the journal system and reappears as a formal submission,” she said. “In our process, before transferring the paper to the journal editors, authors have a chance to update the files (for example, to add a cover letter) and answer the standard questions that we ask, including ones about reviewer suggestions and exclusion requests. Once that step is done, the paper is handed over to the editorial team, and it’s ready to go for consideration in the same way as any other submission.”

 

 

Who’s reading?

Regardless of whether peer-review journals grant them legitimacy, preprints are getting a lot of views. A recent research letter, published in JAMA, looked at readership and online attention in 7,750 preprints posted from November 2013 to January 2017.

Primary author Stylianos Serghiou then selected 776 papers that had first appeared in bioRxiv, and matched them with 3,647 peer-reviewed articles lacking preprint exposure. He examined several publishing metrics for the papers, including views and downloads, citations in other sources, and Altmetric scores.

Altmetric tracks digital attention to scientific papers: Wikipedia citations, mentions in policy documents, blog discussions, and social media mentions including Facebook, Reddit, and Twitter. An Altmetric “attention score” of more than 20 corresponds to articles in the top 5% of readership, he said in an interview.

“Almost one in five of the bioRxiv preprints were getting these very high Almetric scores – much higher scores than articles that had no preprint posting,” Mr. Serghiou said in an interview.

Other findings include:

 

 

  • The median number of preprint abstract views was 924, and the median number of PDF downloads was 321.
  • In total, 18% of the preprints achieved an Altmetric score of more than 20.
  • Of 7,750 preprints, 55% were accepted in a peer-reviewed publication within 24 months.
  • Altmetric scores were significantly higher in articles in preprints (median 9.5 vs. 3.5).

The differences are probably related, at least in part, to the digital media savvy of preprint authors, Mr. Serghiou suggested. “We speculate that people who publish in bioRxiv may be more familiar with social media methods of making others aware of their work. They tend to be very good at using platforms like Twitter and Facebook to promote their results.”

Despite the high exposure scores, only 10% of bioRxiv articles get any posted comments or feedback – a key raison d’être for using a preprint service.

“Ten percent doesn’t sound like a very robust [feedback], but most journal articles get no comments whatsoever,” Dr. Inglis said. “And if they do, especially on the weekly magazines of science, comments may be from someone who has an ax to grind, or who doesn’t know much about the subject.”

What isn’t measured, in either volume or import, is the private communication a preprint engenders, Dr. Inglis said. “Feedback comes directly and privately to the author through email or at meetings or on the phone. We hear time and again that authors get hundreds of downloads after posting, and receive numerous contacts from colleagues who want to know more, to point out weaknesses, or request collaborations. These are the advantages we see from this potentially anxiety-provoking process of putting a manuscript out that has not been approved for publication. The entire purpose is to accelerate the speed of research by accelerating the speed of communication.”

Dr. Inglis, Dr. Sweet, and Dr. Polka are all employees of their respective companies. Dr. Viny and Mr. Serghiou both reported having no financial disclosures relevant to this article.

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