Clinical question: Do thrombin and factor Xa inhibitors increase the risk of gastrointestinal (GI) bleeding when compared to vitamin K antagonists and heparins?

Background: New oral anticoagulants (thrombin and factor Xa inhibitors) are available and being used with increased frequency due to equal efficacy and ease of administration. Some studies indicate a higher risk of GI bleeding with these agents. Further evaluation is needed, because no reversal therapy is available.

Study design: Systematic review and meta-analysis.

Setting: Data from MEDLINE, Embase, and the Cochrane Library.

Synopsis: More than 150,000 patients from 43 randomized controlled trials were evaluated for risk of GI bleed when treated with new anticoagulants versus traditional therapy. Patients were treated for one of the following: embolism prevention from atrial fibrillation, venous thromboembolism (VTE) prophylaxis post orthopedic surgery, VTE prophylaxis of medical patients, acute VTE, and acute coronary syndrome (ACS). Use of aspirin or NSAIDs was discouraged but not documented. The odds ratio for GI bleeding with use of the new anticoagulants was 1.45, with a number needed to harm of 500. Evaluation of subgroups revealed increased GI bleed risk in patients treated for ACS and acute thrombosis versus prophylaxis. Postsurgical patients had the lowest risk. This study was limited by the heterogeneity and differing primary outcomes (mostly efficacy rather than safety) of the included trials. Studies excluded high-risk patients, which the authors estimate to be 25%–40% of actual patients. More studies need to be done that include high-risk patients and focus on GI bleed as a primary outcome.

Bottom line: The new anticoagulants tend to have a higher incidence of GI bleed than traditional therapy, but this varies based on indication of therapy and needs further evaluation to clarify risk.

Citation: Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ET. New oral anticoagulants increase risk for gastrointestinal bleeding: A systematic review and meta-analysis. Gastroenterology. 2013;145(1):105–112.

Clinical question: Do thrombin and factor Xa inhibitors increase the risk of gastrointestinal (GI) bleeding when compared to vitamin K antagonists and heparins?

Background: New oral anticoagulants (thrombin and factor Xa inhibitors) are available and being used with increased frequency due to equal efficacy and ease of administration. Some studies indicate a higher risk of GI bleeding with these agents. Further evaluation is needed, because no reversal therapy is available.

Study design: Systematic review and meta-analysis.

Setting: Data from MEDLINE, Embase, and the Cochrane Library.

Synopsis: More than 150,000 patients from 43 randomized controlled trials were evaluated for risk of GI bleed when treated with new anticoagulants versus traditional therapy. Patients were treated for one of the following: embolism prevention from atrial fibrillation, venous thromboembolism (VTE) prophylaxis post orthopedic surgery, VTE prophylaxis of medical patients, acute VTE, and acute coronary syndrome (ACS). Use of aspirin or NSAIDs was discouraged but not documented. The odds ratio for GI bleeding with use of the new anticoagulants was 1.45, with a number needed to harm of 500. Evaluation of subgroups revealed increased GI bleed risk in patients treated for ACS and acute thrombosis versus prophylaxis. Postsurgical patients had the lowest risk. This study was limited by the heterogeneity and differing primary outcomes (mostly efficacy rather than safety) of the included trials. Studies excluded high-risk patients, which the authors estimate to be 25%–40% of actual patients. More studies need to be done that include high-risk patients and focus on GI bleed as a primary outcome.

Bottom line: The new anticoagulants tend to have a higher incidence of GI bleed than traditional therapy, but this varies based on indication of therapy and needs further evaluation to clarify risk.

Citation: Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ET. New oral anticoagulants increase risk for gastrointestinal bleeding: A systematic review and meta-analysis. Gastroenterology. 2013;145(1):105–112.

Clinical question: Do thrombin and factor Xa inhibitors increase the risk of gastrointestinal (GI) bleeding when compared to vitamin K antagonists and heparins?

Background: New oral anticoagulants (thrombin and factor Xa inhibitors) are available and being used with increased frequency due to equal efficacy and ease of administration. Some studies indicate a higher risk of GI bleeding with these agents. Further evaluation is needed, because no reversal therapy is available.

Study design: Systematic review and meta-analysis.

Setting: Data from MEDLINE, Embase, and the Cochrane Library.

Synopsis: More than 150,000 patients from 43 randomized controlled trials were evaluated for risk of GI bleed when treated with new anticoagulants versus traditional therapy. Patients were treated for one of the following: embolism prevention from atrial fibrillation, venous thromboembolism (VTE) prophylaxis post orthopedic surgery, VTE prophylaxis of medical patients, acute VTE, and acute coronary syndrome (ACS). Use of aspirin or NSAIDs was discouraged but not documented. The odds ratio for GI bleeding with use of the new anticoagulants was 1.45, with a number needed to harm of 500. Evaluation of subgroups revealed increased GI bleed risk in patients treated for ACS and acute thrombosis versus prophylaxis. Postsurgical patients had the lowest risk. This study was limited by the heterogeneity and differing primary outcomes (mostly efficacy rather than safety) of the included trials. Studies excluded high-risk patients, which the authors estimate to be 25%–40% of actual patients. More studies need to be done that include high-risk patients and focus on GI bleed as a primary outcome.

Bottom line: The new anticoagulants tend to have a higher incidence of GI bleed than traditional therapy, but this varies based on indication of therapy and needs further evaluation to clarify risk.

Citation: Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ET. New oral anticoagulants increase risk for gastrointestinal bleeding: A systematic review and meta-analysis. Gastroenterology. 2013;145(1):105–112.

Presenters: Michelle Mourad, MD, director of quality and safety, UCSF School of Medicine, San Francsicso; Nasim Afsar, MD, associate chief medical officer, UCLA Hospitals, Los Angeles

“The goal is to inspire the to believe what you believe,” urged Dr. Mourad, who, along with her co-presenter, Dr. Afsar, outlined the steps needed to create a successful QI project. The steps for a successful QI project should include the following:

• Understand the problem. Often a fishbone diagram can be created while brainstorming about why you have the problem.
• Convince others there is a problem. “Every project needs a sense of urgency,” stated Dr. Mourad. Engaging others in your organization in the problem often requires appealing to both the analytical and the emotional sides of the brain. “Find the patient stories that move you.”
• Identify areas for improvement. This often will require a prioritization matrix. Starting with high impact/low effort aspects of the project may be appropriate.
• Prioritize small tests of change. Aims must be attainable, as unattainable goals may be discouraging when they are missed.
• Devise a measurement strategy. Collecting data is challenging but will allow you to ensure the problem you are fixing will result in improved outcomes.
• Measure change. This can involve measuring outcomes, processes, structure, and possibly balancing measures (unintended consequences). Integrate measurement into a daily routine, and consider using data already being collected if this is easier.
• Sustain the change. Coaching can improve motivation to continue the QI effort. Track improvement using statistical process charts, and celebrate success. Creating and referring to readily accessible data will help put process ownership into the group.

QI is a four-legged stool, concluded Drs. Mourad and Afsar: education, data audit and feedback, systems change, and culture change. TH

Dr. Chang is a pediatric hospitalist with the University of San Diego Medical Center and Rady Children's Hospital, San Diego, and the pediatric editor for The Hospitalist.

Presenters: Michelle Mourad, MD, director of quality and safety, UCSF School of Medicine, San Francsicso; Nasim Afsar, MD, associate chief medical officer, UCLA Hospitals, Los Angeles

“The goal is to inspire the to believe what you believe,” urged Dr. Mourad, who, along with her co-presenter, Dr. Afsar, outlined the steps needed to create a successful QI project. The steps for a successful QI project should include the following:

• Understand the problem. Often a fishbone diagram can be created while brainstorming about why you have the problem.
• Convince others there is a problem. “Every project needs a sense of urgency,” stated Dr. Mourad. Engaging others in your organization in the problem often requires appealing to both the analytical and the emotional sides of the brain. “Find the patient stories that move you.”
• Identify areas for improvement. This often will require a prioritization matrix. Starting with high impact/low effort aspects of the project may be appropriate.
• Prioritize small tests of change. Aims must be attainable, as unattainable goals may be discouraging when they are missed.
• Devise a measurement strategy. Collecting data is challenging but will allow you to ensure the problem you are fixing will result in improved outcomes.
• Measure change. This can involve measuring outcomes, processes, structure, and possibly balancing measures (unintended consequences). Integrate measurement into a daily routine, and consider using data already being collected if this is easier.
• Sustain the change. Coaching can improve motivation to continue the QI effort. Track improvement using statistical process charts, and celebrate success. Creating and referring to readily accessible data will help put process ownership into the group.

QI is a four-legged stool, concluded Drs. Mourad and Afsar: education, data audit and feedback, systems change, and culture change. TH

Dr. Chang is a pediatric hospitalist with the University of San Diego Medical Center and Rady Children's Hospital, San Diego, and the pediatric editor for The Hospitalist.

Presenters: Michelle Mourad, MD, director of quality and safety, UCSF School of Medicine, San Francsicso; Nasim Afsar, MD, associate chief medical officer, UCLA Hospitals, Los Angeles

“The goal is to inspire the to believe what you believe,” urged Dr. Mourad, who, along with her co-presenter, Dr. Afsar, outlined the steps needed to create a successful QI project. The steps for a successful QI project should include the following:

• Understand the problem. Often a fishbone diagram can be created while brainstorming about why you have the problem.
• Convince others there is a problem. “Every project needs a sense of urgency,” stated Dr. Mourad. Engaging others in your organization in the problem often requires appealing to both the analytical and the emotional sides of the brain. “Find the patient stories that move you.”
• Identify areas for improvement. This often will require a prioritization matrix. Starting with high impact/low effort aspects of the project may be appropriate.
• Prioritize small tests of change. Aims must be attainable, as unattainable goals may be discouraging when they are missed.
• Devise a measurement strategy. Collecting data is challenging but will allow you to ensure the problem you are fixing will result in improved outcomes.
• Measure change. This can involve measuring outcomes, processes, structure, and possibly balancing measures (unintended consequences). Integrate measurement into a daily routine, and consider using data already being collected if this is easier.
• Sustain the change. Coaching can improve motivation to continue the QI effort. Track improvement using statistical process charts, and celebrate success. Creating and referring to readily accessible data will help put process ownership into the group.

QI is a four-legged stool, concluded Drs. Mourad and Afsar: education, data audit and feedback, systems change, and culture change. TH

Dr. Chang is a pediatric hospitalist with the University of San Diego Medical Center and Rady Children's Hospital, San Diego, and the pediatric editor for The Hospitalist.

Presenter: Derek M. Fine, MD

Dr. Fine's presentation covered several areas of nephrology that are of special interest for hospitalists in the day-to-day management of our patients.

Drug toxicities and renal clearance. We need to know the GFR of our patients. This will, for example, keep us from ordering an MRI with gadolinium in patients with impaired renal function and prevent the debilitating complication of nephrogenic systemic fibrosis.

There are multiple medications that are frequently dosed inappropriately in CKD. Examples that stick out are: nitrofurantoin (contraindicated); gabapentin, which can cause confusion, decreased level of consciousness, and unsteady gait; and cefepime, which can cause non-convulsive status epilepticus, if not adjusted for GFR.

Ultrafiltration in CHF. The use of ultrafiltration in decompensated CHF is limited. There is no benefit over diuretic therapy in general, except for subgroups of patients, who have inadequate volume control with diuretics or who do not tolerate diuretics because of significant electrolyte abnormalities or alkalosis. A pearl for sodium restriction and IV fluids IV NS at 84 ml/hr for 24 hours provides 7000 mg of sodium for our heart-failure patients.

Dialysis access issues. Avoid PICC lines in patients with advanced CKD and ESRD in order to preserve access sites for dialysis. Don't discharge a patient with a bleeding AV fistula as they could bleed to death. A clotted AV access requires consultation with vascular surgery or interventional radiology, although it can be de-clotted for up to 2 weeks.

Renal artery stenosis. Angioplasty has not shown any benefit over medical therapy in the management of renal artery stenosis.

Key Takeaways:

• Know your patients' GFR
• Pay attention to dose adjustments in patients with CKD. It seems obvious, but dosing errors are very common.
• Preserve dialysis access sites and don't place PICC lines in patients who will need dialysis soon.
• Each liter of normal saline delivers 3542 mg of sodium to our CHF patients.

Klaus Suehler is a hospitalist at Mercy Hospital at Allina Health in Coon Rapids, MN, and a member of Team Hospitalist.

Presenter: Derek M. Fine, MD

Dr. Fine's presentation covered several areas of nephrology that are of special interest for hospitalists in the day-to-day management of our patients.

Drug toxicities and renal clearance. We need to know the GFR of our patients. This will, for example, keep us from ordering an MRI with gadolinium in patients with impaired renal function and prevent the debilitating complication of nephrogenic systemic fibrosis.

There are multiple medications that are frequently dosed inappropriately in CKD. Examples that stick out are: nitrofurantoin (contraindicated); gabapentin, which can cause confusion, decreased level of consciousness, and unsteady gait; and cefepime, which can cause non-convulsive status epilepticus, if not adjusted for GFR.

Ultrafiltration in CHF. The use of ultrafiltration in decompensated CHF is limited. There is no benefit over diuretic therapy in general, except for subgroups of patients, who have inadequate volume control with diuretics or who do not tolerate diuretics because of significant electrolyte abnormalities or alkalosis. A pearl for sodium restriction and IV fluids IV NS at 84 ml/hr for 24 hours provides 7000 mg of sodium for our heart-failure patients.

Dialysis access issues. Avoid PICC lines in patients with advanced CKD and ESRD in order to preserve access sites for dialysis. Don't discharge a patient with a bleeding AV fistula as they could bleed to death. A clotted AV access requires consultation with vascular surgery or interventional radiology, although it can be de-clotted for up to 2 weeks.

Renal artery stenosis. Angioplasty has not shown any benefit over medical therapy in the management of renal artery stenosis.

Key Takeaways:

• Know your patients' GFR
• Pay attention to dose adjustments in patients with CKD. It seems obvious, but dosing errors are very common.
• Preserve dialysis access sites and don't place PICC lines in patients who will need dialysis soon.
• Each liter of normal saline delivers 3542 mg of sodium to our CHF patients.

Klaus Suehler is a hospitalist at Mercy Hospital at Allina Health in Coon Rapids, MN, and a member of Team Hospitalist.

Presenter: Derek M. Fine, MD

Dr. Fine's presentation covered several areas of nephrology that are of special interest for hospitalists in the day-to-day management of our patients.

Drug toxicities and renal clearance. We need to know the GFR of our patients. This will, for example, keep us from ordering an MRI with gadolinium in patients with impaired renal function and prevent the debilitating complication of nephrogenic systemic fibrosis.

There are multiple medications that are frequently dosed inappropriately in CKD. Examples that stick out are: nitrofurantoin (contraindicated); gabapentin, which can cause confusion, decreased level of consciousness, and unsteady gait; and cefepime, which can cause non-convulsive status epilepticus, if not adjusted for GFR.

Ultrafiltration in CHF. The use of ultrafiltration in decompensated CHF is limited. There is no benefit over diuretic therapy in general, except for subgroups of patients, who have inadequate volume control with diuretics or who do not tolerate diuretics because of significant electrolyte abnormalities or alkalosis. A pearl for sodium restriction and IV fluids IV NS at 84 ml/hr for 24 hours provides 7000 mg of sodium for our heart-failure patients.

Dialysis access issues. Avoid PICC lines in patients with advanced CKD and ESRD in order to preserve access sites for dialysis. Don't discharge a patient with a bleeding AV fistula as they could bleed to death. A clotted AV access requires consultation with vascular surgery or interventional radiology, although it can be de-clotted for up to 2 weeks.

Renal artery stenosis. Angioplasty has not shown any benefit over medical therapy in the management of renal artery stenosis.

Key Takeaways:

• Know your patients' GFR
• Pay attention to dose adjustments in patients with CKD. It seems obvious, but dosing errors are very common.
• Preserve dialysis access sites and don't place PICC lines in patients who will need dialysis soon.
• Each liter of normal saline delivers 3542 mg of sodium to our CHF patients.

Klaus Suehler is a hospitalist at Mercy Hospital at Allina Health in Coon Rapids, MN, and a member of Team Hospitalist.

3/26/14. Day 3 at SGS
Debates, rebuttals, and relaxation

The morning at SGS was divided up between the small-group academic roundtables with experts in the fields. Topics ranged from mesh complications to coding and billing, and even a primer on urology for the gynecologist.

In the main hall, Drs. Dee Feener and Mark Walters outlined the challenges and opportunities for training the next generation of gynecologic surgeons. Dr. Feener argued that there simply are not enough cases, not enough time, and not enough people to train excellent surgeons. A perfect storm. Dr. Walters outlined his program and resident support at the Cleveland Clinic, showing how to provide robust experience and feedback to residents and fellows. Questions from the audience were pointed, and questioned the need to track obstetrics and gynecology separately for trainees.

Oral posters today also added to the debate with Vanderbilt sharing their hysterectomy training experience both before and after adding a fellowship. They did not see any change in vaginal hysterectomy participation over time. Most interesting was a study looking at abstract acceptance rates if an institution, research network, or author were disclosed in the body of a blinded abstract. They saw a much higher rate of acceptance if the source of the research was known by the reviewer. In his discussion, Dr. John Gebhart mused if the quality of these studies were somehow better, or if this perceived association resulted in any true bias. Nevertheless, the audience was actively engaged in the discussion.

The morning's highlight was certainly the debate over cosmetic gynecologic surgery. Dr. Rachel Pauls advocated FOR labiaplasty and Dr. Becky Rogers AGAINST. Though spirited and based largely on the principals of medical ethics, the final blow came from Dr. Rogers as she distributed Love Our Labia (LOL) buttons to the audience and presented Dr. Pauls with a pink LOL t-shirt. The Twitter feed exploded after this. 

Follow us on Twitter @obgmanagement #SGS14.

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends. 

We were also honored to have Dr. Clifford Ko, director of the American College of Surgeons Quality Improvement Program, as the esteemed Telinde lecturer. This robust and data-filled talk underlines his thesis that accurate, believable, and actionable data can be used to create quality in surgery. Quality improvement is local, he stated, and culture is the hardest institutional characteristic to change. Though any team working together on quality will elevate their culture if the data are good and the benefit to patients is clear. Dr. Ko, a colorectal surgeon at UCLA, is also now an honorary member of SGS.

The afternoon adjourned after the business meeting, and members were able to play golf, tour the desert in 4-wheel drive, or just relax in the lazy river by the pool. Activities were threatened by a large dust storm in Phoenix, but I have heard of no reports of problems.

Everyone convened at the outside terrace for the evening Fiesta Margarita reception. Over drinks and Southwest-themed sombreros, the new Michael Aronson Fund was announced to support Surgeons Helping Advance Research and Education (SHARE). This was the result of more than $25,000 raised by the program committee and SGS Board. Tomorrow looks to be an excellent conclusion to a well-planned and very well-executed meeting.

Follow us on Twitter @obgmanagement #SGS14.

3/25/14. Day 2 at SGS
Scientific sessions and socializing

The first day of the SGS scientific sessions was another energetic and interactive day. Oral posters stimulated heated debates on uterine morcellation, asymptomatic prolapse, and resident training. The Fellows Pelvic Research Network (FPRN) presented their work on the introduction of robotic hysterectomies to training centers. They showed that number of hysterectomies went down, and participation in robotic cases was poor. 

This was followed by the exceptional keynote address by Dr. Barbara Levy. She shared her expertise of health policy and described the coming of quality-based payment, value in Supervises, and the need to protect resources. She predicted that hospitals need to cut costs by 25% to 30% in the next 5 years just to survive.

The afternoon videofest included surgical techniques, anatomy instruction, and a comprehensive review on bowel surgery for the practicing gynecologist. 

For the second year running, the SGS hosted a mock NIH study session. Dr. Katherine Hartmann of Vanderbilt University provided background prep to prepare fellows for a K or R award application. Combined with a most-study section review of two actual applications demystified the process of grant review (and rejection). 

The FPRN met to update their ongoing projects and to review new proposals. This was an enlightening and engaging session which should give everyone great hope to see the creativity and energy of the next generation of researchers. 

SGS President Dr. Holly Richter had the great honor to present the best poster and video awards, as well as recognize the largest new-member class in the history of SGS. Dr. Norton was recognized for the best member presentation, which was on long-term prolapse follow-up in the TOMUS trial cohort. The FPRN was also recognized for their work on the impact of robotic hysterectomy in training. 

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends.

3/24/14. Day 1 at SGS
Postgraduate course examines cautions and takeaways from published research

Our first day at the annual Society of Gynecologic Surgeons Scientific Meeting was off to a running start at the Postgraduate Courses. Program Chair Dr. Cheryl Iglesia joined me for a rapid-fire account of the evidence-based medicine course on social media.

The SGS birth on Twitter was explosive, with our four social media Fellow Scholars linking real-time comments to the courses. Dr. Vivian Sung put together an amazing team to review and apply the principles of evidence-based medicine for the course attendees. Once we accepted that most published research was bad and not terribly generalizable, small break-out groups were quick to use the PICO-S model to define (or try to define) a Population, Intervention, Comparator, Outcomes, and Study design.

This was followed by Dr. Ethan Balk of Tufts Center for Clinical Evidence Synthesis helping us wrap our heads around the randomized controlled trial (RCT). His caution was to consider the costly and underpowered trial, and lack of generalizability needed to define rigorous study inclusion and outcome criteria.

More bad news followed when Dr. Sung reviewed the cautionary tale of surrogate outcomes. While the perfect surrogate would allow us to shorten studies and save money, the seduction of association and causation can lead to some questionable conclusions. Are anatomical and urodynamic outcomes the same as patient perception of cure and improvement?

It wasn't all doom and gloom, as reflected in the lively tweets and posts by @obgmanagement and @gynsurgery. The strong work of the SGS Systemic Review Committee was lauded by Dr. Miles Murphy in his "How to Use a Clinical Practice Guideline." A systematic review needs to be included, though a meta-analysis is not always required, he said. What limits us is the poor quality and paucity of randomized trials for most patient populations. Treatment effect is best shown in RCTs, but minimizes harm; cohort and case series are better. Patient registries may allow for better determining a denominator and harm "rates," though they will miss clinical patient-based outcomes. With the coming of comparative effectiveness, these registries will be online quickly. Further, Dr. Balk showed us that, with more than 13,000 gynecologic research papers published each year, no one could ever keep track.

Dr. Ike Rahn gave an excellent presentation of subgroup analysis. To summarize: do it cautiously, describe which groups you analyze and have statistical back-up for your power and P-value calculations.

To round out the course, Dr. John Wong took us through his crystal ball on the future of evidence-based medicine. Because RCTs are expensive and comprise less than 2.5% of published studies, he proposed the analysis of observational studies as RCTs. Using patient-centered outcomes, efficacy data, and multiple providers, we will be better able to inform our patient and our colleagues on the best treatments. Again, as comparative effectiveness broadens policy decision, we must be agile, adaptive, and accountable.

Follow us on Twitter @obgmanagement #SGS14

3/26/14. Day 3 at SGS
Debates, rebuttals, and relaxation

The morning at SGS was divided up between the small-group academic roundtables with experts in the fields. Topics ranged from mesh complications to coding and billing, and even a primer on urology for the gynecologist.

In the main hall, Drs. Dee Feener and Mark Walters outlined the challenges and opportunities for training the next generation of gynecologic surgeons. Dr. Feener argued that there simply are not enough cases, not enough time, and not enough people to train excellent surgeons. A perfect storm. Dr. Walters outlined his program and resident support at the Cleveland Clinic, showing how to provide robust experience and feedback to residents and fellows. Questions from the audience were pointed, and questioned the need to track obstetrics and gynecology separately for trainees.

Oral posters today also added to the debate with Vanderbilt sharing their hysterectomy training experience both before and after adding a fellowship. They did not see any change in vaginal hysterectomy participation over time. Most interesting was a study looking at abstract acceptance rates if an institution, research network, or author were disclosed in the body of a blinded abstract. They saw a much higher rate of acceptance if the source of the research was known by the reviewer. In his discussion, Dr. John Gebhart mused if the quality of these studies were somehow better, or if this perceived association resulted in any true bias. Nevertheless, the audience was actively engaged in the discussion.

The morning's highlight was certainly the debate over cosmetic gynecologic surgery. Dr. Rachel Pauls advocated FOR labiaplasty and Dr. Becky Rogers AGAINST. Though spirited and based largely on the principals of medical ethics, the final blow came from Dr. Rogers as she distributed Love Our Labia (LOL) buttons to the audience and presented Dr. Pauls with a pink LOL t-shirt. The Twitter feed exploded after this. 

Follow us on Twitter @obgmanagement #SGS14.

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends. 

We were also honored to have Dr. Clifford Ko, director of the American College of Surgeons Quality Improvement Program, as the esteemed Telinde lecturer. This robust and data-filled talk underlines his thesis that accurate, believable, and actionable data can be used to create quality in surgery. Quality improvement is local, he stated, and culture is the hardest institutional characteristic to change. Though any team working together on quality will elevate their culture if the data are good and the benefit to patients is clear. Dr. Ko, a colorectal surgeon at UCLA, is also now an honorary member of SGS.

The afternoon adjourned after the business meeting, and members were able to play golf, tour the desert in 4-wheel drive, or just relax in the lazy river by the pool. Activities were threatened by a large dust storm in Phoenix, but I have heard of no reports of problems.

Everyone convened at the outside terrace for the evening Fiesta Margarita reception. Over drinks and Southwest-themed sombreros, the new Michael Aronson Fund was announced to support Surgeons Helping Advance Research and Education (SHARE). This was the result of more than $25,000 raised by the program committee and SGS Board. Tomorrow looks to be an excellent conclusion to a well-planned and very well-executed meeting.

Follow us on Twitter @obgmanagement #SGS14.

3/25/14. Day 2 at SGS
Scientific sessions and socializing

The first day of the SGS scientific sessions was another energetic and interactive day. Oral posters stimulated heated debates on uterine morcellation, asymptomatic prolapse, and resident training. The Fellows Pelvic Research Network (FPRN) presented their work on the introduction of robotic hysterectomies to training centers. They showed that number of hysterectomies went down, and participation in robotic cases was poor. 

This was followed by the exceptional keynote address by Dr. Barbara Levy. She shared her expertise of health policy and described the coming of quality-based payment, value in Supervises, and the need to protect resources. She predicted that hospitals need to cut costs by 25% to 30% in the next 5 years just to survive.

The afternoon videofest included surgical techniques, anatomy instruction, and a comprehensive review on bowel surgery for the practicing gynecologist. 

For the second year running, the SGS hosted a mock NIH study session. Dr. Katherine Hartmann of Vanderbilt University provided background prep to prepare fellows for a K or R award application. Combined with a most-study section review of two actual applications demystified the process of grant review (and rejection). 

The FPRN met to update their ongoing projects and to review new proposals. This was an enlightening and engaging session which should give everyone great hope to see the creativity and energy of the next generation of researchers. 

SGS President Dr. Holly Richter had the great honor to present the best poster and video awards, as well as recognize the largest new-member class in the history of SGS. Dr. Norton was recognized for the best member presentation, which was on long-term prolapse follow-up in the TOMUS trial cohort. The FPRN was also recognized for their work on the impact of robotic hysterectomy in training. 

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends.

3/24/14. Day 1 at SGS
Postgraduate course examines cautions and takeaways from published research

Our first day at the annual Society of Gynecologic Surgeons Scientific Meeting was off to a running start at the Postgraduate Courses. Program Chair Dr. Cheryl Iglesia joined me for a rapid-fire account of the evidence-based medicine course on social media.

The SGS birth on Twitter was explosive, with our four social media Fellow Scholars linking real-time comments to the courses. Dr. Vivian Sung put together an amazing team to review and apply the principles of evidence-based medicine for the course attendees. Once we accepted that most published research was bad and not terribly generalizable, small break-out groups were quick to use the PICO-S model to define (or try to define) a Population, Intervention, Comparator, Outcomes, and Study design.

This was followed by Dr. Ethan Balk of Tufts Center for Clinical Evidence Synthesis helping us wrap our heads around the randomized controlled trial (RCT). His caution was to consider the costly and underpowered trial, and lack of generalizability needed to define rigorous study inclusion and outcome criteria.

More bad news followed when Dr. Sung reviewed the cautionary tale of surrogate outcomes. While the perfect surrogate would allow us to shorten studies and save money, the seduction of association and causation can lead to some questionable conclusions. Are anatomical and urodynamic outcomes the same as patient perception of cure and improvement?

It wasn't all doom and gloom, as reflected in the lively tweets and posts by @obgmanagement and @gynsurgery. The strong work of the SGS Systemic Review Committee was lauded by Dr. Miles Murphy in his "How to Use a Clinical Practice Guideline." A systematic review needs to be included, though a meta-analysis is not always required, he said. What limits us is the poor quality and paucity of randomized trials for most patient populations. Treatment effect is best shown in RCTs, but minimizes harm; cohort and case series are better. Patient registries may allow for better determining a denominator and harm "rates," though they will miss clinical patient-based outcomes. With the coming of comparative effectiveness, these registries will be online quickly. Further, Dr. Balk showed us that, with more than 13,000 gynecologic research papers published each year, no one could ever keep track.

Dr. Ike Rahn gave an excellent presentation of subgroup analysis. To summarize: do it cautiously, describe which groups you analyze and have statistical back-up for your power and P-value calculations.

To round out the course, Dr. John Wong took us through his crystal ball on the future of evidence-based medicine. Because RCTs are expensive and comprise less than 2.5% of published studies, he proposed the analysis of observational studies as RCTs. Using patient-centered outcomes, efficacy data, and multiple providers, we will be better able to inform our patient and our colleagues on the best treatments. Again, as comparative effectiveness broadens policy decision, we must be agile, adaptive, and accountable.

Follow us on Twitter @obgmanagement #SGS14

3/26/14. Day 3 at SGS
Debates, rebuttals, and relaxation

The morning at SGS was divided up between the small-group academic roundtables with experts in the fields. Topics ranged from mesh complications to coding and billing, and even a primer on urology for the gynecologist.

In the main hall, Drs. Dee Feener and Mark Walters outlined the challenges and opportunities for training the next generation of gynecologic surgeons. Dr. Feener argued that there simply are not enough cases, not enough time, and not enough people to train excellent surgeons. A perfect storm. Dr. Walters outlined his program and resident support at the Cleveland Clinic, showing how to provide robust experience and feedback to residents and fellows. Questions from the audience were pointed, and questioned the need to track obstetrics and gynecology separately for trainees.

Oral posters today also added to the debate with Vanderbilt sharing their hysterectomy training experience both before and after adding a fellowship. They did not see any change in vaginal hysterectomy participation over time. Most interesting was a study looking at abstract acceptance rates if an institution, research network, or author were disclosed in the body of a blinded abstract. They saw a much higher rate of acceptance if the source of the research was known by the reviewer. In his discussion, Dr. John Gebhart mused if the quality of these studies were somehow better, or if this perceived association resulted in any true bias. Nevertheless, the audience was actively engaged in the discussion.

The morning's highlight was certainly the debate over cosmetic gynecologic surgery. Dr. Rachel Pauls advocated FOR labiaplasty and Dr. Becky Rogers AGAINST. Though spirited and based largely on the principals of medical ethics, the final blow came from Dr. Rogers as she distributed Love Our Labia (LOL) buttons to the audience and presented Dr. Pauls with a pink LOL t-shirt. The Twitter feed exploded after this. 

Follow us on Twitter @obgmanagement #SGS14.

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends. 

We were also honored to have Dr. Clifford Ko, director of the American College of Surgeons Quality Improvement Program, as the esteemed Telinde lecturer. This robust and data-filled talk underlines his thesis that accurate, believable, and actionable data can be used to create quality in surgery. Quality improvement is local, he stated, and culture is the hardest institutional characteristic to change. Though any team working together on quality will elevate their culture if the data are good and the benefit to patients is clear. Dr. Ko, a colorectal surgeon at UCLA, is also now an honorary member of SGS.

The afternoon adjourned after the business meeting, and members were able to play golf, tour the desert in 4-wheel drive, or just relax in the lazy river by the pool. Activities were threatened by a large dust storm in Phoenix, but I have heard of no reports of problems.

Everyone convened at the outside terrace for the evening Fiesta Margarita reception. Over drinks and Southwest-themed sombreros, the new Michael Aronson Fund was announced to support Surgeons Helping Advance Research and Education (SHARE). This was the result of more than $25,000 raised by the program committee and SGS Board. Tomorrow looks to be an excellent conclusion to a well-planned and very well-executed meeting.

Follow us on Twitter @obgmanagement #SGS14.

3/25/14. Day 2 at SGS
Scientific sessions and socializing

The first day of the SGS scientific sessions was another energetic and interactive day. Oral posters stimulated heated debates on uterine morcellation, asymptomatic prolapse, and resident training. The Fellows Pelvic Research Network (FPRN) presented their work on the introduction of robotic hysterectomies to training centers. They showed that number of hysterectomies went down, and participation in robotic cases was poor. 

This was followed by the exceptional keynote address by Dr. Barbara Levy. She shared her expertise of health policy and described the coming of quality-based payment, value in Supervises, and the need to protect resources. She predicted that hospitals need to cut costs by 25% to 30% in the next 5 years just to survive.

The afternoon videofest included surgical techniques, anatomy instruction, and a comprehensive review on bowel surgery for the practicing gynecologist. 

For the second year running, the SGS hosted a mock NIH study session. Dr. Katherine Hartmann of Vanderbilt University provided background prep to prepare fellows for a K or R award application. Combined with a most-study section review of two actual applications demystified the process of grant review (and rejection). 

The FPRN met to update their ongoing projects and to review new proposals. This was an enlightening and engaging session which should give everyone great hope to see the creativity and energy of the next generation of researchers. 

SGS President Dr. Holly Richter had the great honor to present the best poster and video awards, as well as recognize the largest new-member class in the history of SGS. Dr. Norton was recognized for the best member presentation, which was on long-term prolapse follow-up in the TOMUS trial cohort. The FPRN was also recognized for their work on the impact of robotic hysterectomy in training. 

The evening wrapped up with a lively social event in the exhibit hall with the meeting sponsors, colleagues, and friends.

3/24/14. Day 1 at SGS
Postgraduate course examines cautions and takeaways from published research

Our first day at the annual Society of Gynecologic Surgeons Scientific Meeting was off to a running start at the Postgraduate Courses. Program Chair Dr. Cheryl Iglesia joined me for a rapid-fire account of the evidence-based medicine course on social media.

The SGS birth on Twitter was explosive, with our four social media Fellow Scholars linking real-time comments to the courses. Dr. Vivian Sung put together an amazing team to review and apply the principles of evidence-based medicine for the course attendees. Once we accepted that most published research was bad and not terribly generalizable, small break-out groups were quick to use the PICO-S model to define (or try to define) a Population, Intervention, Comparator, Outcomes, and Study design.

This was followed by Dr. Ethan Balk of Tufts Center for Clinical Evidence Synthesis helping us wrap our heads around the randomized controlled trial (RCT). His caution was to consider the costly and underpowered trial, and lack of generalizability needed to define rigorous study inclusion and outcome criteria.

More bad news followed when Dr. Sung reviewed the cautionary tale of surrogate outcomes. While the perfect surrogate would allow us to shorten studies and save money, the seduction of association and causation can lead to some questionable conclusions. Are anatomical and urodynamic outcomes the same as patient perception of cure and improvement?

It wasn't all doom and gloom, as reflected in the lively tweets and posts by @obgmanagement and @gynsurgery. The strong work of the SGS Systemic Review Committee was lauded by Dr. Miles Murphy in his "How to Use a Clinical Practice Guideline." A systematic review needs to be included, though a meta-analysis is not always required, he said. What limits us is the poor quality and paucity of randomized trials for most patient populations. Treatment effect is best shown in RCTs, but minimizes harm; cohort and case series are better. Patient registries may allow for better determining a denominator and harm "rates," though they will miss clinical patient-based outcomes. With the coming of comparative effectiveness, these registries will be online quickly. Further, Dr. Balk showed us that, with more than 13,000 gynecologic research papers published each year, no one could ever keep track.

Dr. Ike Rahn gave an excellent presentation of subgroup analysis. To summarize: do it cautiously, describe which groups you analyze and have statistical back-up for your power and P-value calculations.

To round out the course, Dr. John Wong took us through his crystal ball on the future of evidence-based medicine. Because RCTs are expensive and comprise less than 2.5% of published studies, he proposed the analysis of observational studies as RCTs. Using patient-centered outcomes, efficacy data, and multiple providers, we will be better able to inform our patient and our colleagues on the best treatments. Again, as comparative effectiveness broadens policy decision, we must be agile, adaptive, and accountable.

Follow us on Twitter @obgmanagement #SGS14

Blood for transfusion

Credit: Elise Amendola

A review of randomized trials indicates that a restrictive approach to blood transfusion can decrease the risk of healthcare-associated infections (HAIs) for some patients.

Investigators found that, overall, restricting red blood cell (RBC) transfusions to patients with hemoglobin concentrations of 7 g/dL or less was associated with a lower incidence of HAIs such as pneumonia, mediastinitis, and sepsis.

However, when they stratified results by patient type, the researchers found that a restrictive transfusion approach significantly decreased the risk of HAIs only for patients who already had sepsis or were undergoing orthopedic surgery.

Jeffrey M. Rohde, MD, of the University of Michigan in Ann Arbor, and his colleagues reported these findings in JAMA.

The investigators set out to compare restrictive and liberal RBC transfusion strategies using data from 21 randomized trials in 9 countries. Eighteen of the trials (n=7593) contained enough information for a meta-analysis.

The pooled risk of all serious HAIs was 11.8% for patients treated with a restrictive transfusion approach and 16.9% for patients treated with a liberal approach. The risk ratio (RR) for the association between transfusion strategies and serious infection was 0.82.

“The fewer the red blood cell transfusions, the less likely hospitalized patients were to develop infections,” Dr Rohde said. “This is most likely due to the patient’s immune system reacting to donor blood [known as transfusion-associated immunomodulation].”

Even when the transfusions were leukoreduced, the risk of infection remained lower with a restrictive transfusion strategy. The RR was 0.80.

The results suggested that, for every 1000 patients in which RBC transfusion is a consideration, 26 could potentially be spared an HAI if restrictive strategies were used.

On the other hand, the investigators found no significant differences in the incidence of HAIs by RBC threshold for patients with cardiac disease, the critically ill, those with acute upper gastrointestinal bleeding, or for infants with low birth weight.

Yet the risk of infection was significantly lower with a restrictive strategy for patients who already had sepsis or were undergoing orthopedic surgery. The RRs were 0.51 and 0.70, respectively.

Dr Rohde and his colleagues said these results support AABB’s 2012 guidelines for transfusing hospitalized patients. The guidelines recommend a restrictive strategy for all hospitalized patients but also list specific hemoglobin-based recommendations for different patient populations.

Blood for transfusion

Credit: Elise Amendola

A review of randomized trials indicates that a restrictive approach to blood transfusion can decrease the risk of healthcare-associated infections (HAIs) for some patients.

Investigators found that, overall, restricting red blood cell (RBC) transfusions to patients with hemoglobin concentrations of 7 g/dL or less was associated with a lower incidence of HAIs such as pneumonia, mediastinitis, and sepsis.

However, when they stratified results by patient type, the researchers found that a restrictive transfusion approach significantly decreased the risk of HAIs only for patients who already had sepsis or were undergoing orthopedic surgery.

Jeffrey M. Rohde, MD, of the University of Michigan in Ann Arbor, and his colleagues reported these findings in JAMA.

The investigators set out to compare restrictive and liberal RBC transfusion strategies using data from 21 randomized trials in 9 countries. Eighteen of the trials (n=7593) contained enough information for a meta-analysis.

The pooled risk of all serious HAIs was 11.8% for patients treated with a restrictive transfusion approach and 16.9% for patients treated with a liberal approach. The risk ratio (RR) for the association between transfusion strategies and serious infection was 0.82.

“The fewer the red blood cell transfusions, the less likely hospitalized patients were to develop infections,” Dr Rohde said. “This is most likely due to the patient’s immune system reacting to donor blood [known as transfusion-associated immunomodulation].”

Even when the transfusions were leukoreduced, the risk of infection remained lower with a restrictive transfusion strategy. The RR was 0.80.

The results suggested that, for every 1000 patients in which RBC transfusion is a consideration, 26 could potentially be spared an HAI if restrictive strategies were used.

On the other hand, the investigators found no significant differences in the incidence of HAIs by RBC threshold for patients with cardiac disease, the critically ill, those with acute upper gastrointestinal bleeding, or for infants with low birth weight.

Yet the risk of infection was significantly lower with a restrictive strategy for patients who already had sepsis or were undergoing orthopedic surgery. The RRs were 0.51 and 0.70, respectively.

Dr Rohde and his colleagues said these results support AABB’s 2012 guidelines for transfusing hospitalized patients. The guidelines recommend a restrictive strategy for all hospitalized patients but also list specific hemoglobin-based recommendations for different patient populations.

Blood for transfusion

Credit: Elise Amendola

A review of randomized trials indicates that a restrictive approach to blood transfusion can decrease the risk of healthcare-associated infections (HAIs) for some patients.

Investigators found that, overall, restricting red blood cell (RBC) transfusions to patients with hemoglobin concentrations of 7 g/dL or less was associated with a lower incidence of HAIs such as pneumonia, mediastinitis, and sepsis.

However, when they stratified results by patient type, the researchers found that a restrictive transfusion approach significantly decreased the risk of HAIs only for patients who already had sepsis or were undergoing orthopedic surgery.

Jeffrey M. Rohde, MD, of the University of Michigan in Ann Arbor, and his colleagues reported these findings in JAMA.

The investigators set out to compare restrictive and liberal RBC transfusion strategies using data from 21 randomized trials in 9 countries. Eighteen of the trials (n=7593) contained enough information for a meta-analysis.

The pooled risk of all serious HAIs was 11.8% for patients treated with a restrictive transfusion approach and 16.9% for patients treated with a liberal approach. The risk ratio (RR) for the association between transfusion strategies and serious infection was 0.82.

“The fewer the red blood cell transfusions, the less likely hospitalized patients were to develop infections,” Dr Rohde said. “This is most likely due to the patient’s immune system reacting to donor blood [known as transfusion-associated immunomodulation].”

Even when the transfusions were leukoreduced, the risk of infection remained lower with a restrictive transfusion strategy. The RR was 0.80.

The results suggested that, for every 1000 patients in which RBC transfusion is a consideration, 26 could potentially be spared an HAI if restrictive strategies were used.

On the other hand, the investigators found no significant differences in the incidence of HAIs by RBC threshold for patients with cardiac disease, the critically ill, those with acute upper gastrointestinal bleeding, or for infants with low birth weight.

Yet the risk of infection was significantly lower with a restrictive strategy for patients who already had sepsis or were undergoing orthopedic surgery. The RRs were 0.51 and 0.70, respectively.

Dr Rohde and his colleagues said these results support AABB’s 2012 guidelines for transfusing hospitalized patients. The guidelines recommend a restrictive strategy for all hospitalized patients but also list specific hemoglobin-based recommendations for different patient populations.

Image showing

alleged STAP cells

Credit: Haruko Obokata

The Japanese research institute RIKEN has completed its investigation of the research on STAP cells (stimulus-triggered acquisition of pluripotency cells) and claims that study authors are guilty of misconduct and negligence.

According to RIKEN, lead study author Haruko Obokata, PhD, is guilty of misconduct because she manipulated study data.

And 2 other authors—Yoshiki Sasai, MD, PhD, and Teruhiko Wakayama, PhD—should have recognized the data manipulation.

Dr Obokata denied the allegations and said she plans to appeal this judgment. Drs Wakayama and Sasai wrote letters of apology, but Dr Sasai said he still believes the research is valid.

A group of RIKEN researchers has joined other groups in the attempt to replicate Dr Obokata’s experiments and determine if STAP cells can be generated.

About the investigation

RIKEN’s investigation began shortly after Dr Obokata and her colleagues reported the creation of STAP cells. The researchers said they could induce pluripotency by introducing somatic cells to a low-pH environment, and they described this discovery in an article and a letter to Nature.

Not long after the papers were published, members of the scientific community began questioning the validity of the research, citing issues with images, possible plagiarism, and an inability to replicate the experiments described.

So RIKEN launched an investigation into 6 issues with the papers. Early results of the investigation revealed 2 cases of “data mishandling” but no misconduct. And the final results of the investigation suggest 2 of the other issues were simply errors.

However, the 2 remaining issues constituted acts of misconduct, according to RIKEN. In the first case, Dr Obokata switched 1 lane of a diagram for another. She said it was for the purpose of image clarity, but the committee said this change was “intentionally misleading.”

Dr Obokata also used an image of a teratoma from her doctoral thesis (which involved different research). She said she mistakenly used the wrong image, but RIKEN said it was a fraudulent act because the caption on the image had been changed.

Next steps

It is still unclear whether the issues identified affect the results of this research. Dr Obokata and other study authors said the errors do not alter the study’s findings, and creating STAP cells is possible.

Other research groups have attempted to create STAP cells, and most results have suggested it is not possible when using the methods described in the Nature paper (or variations of those methods).

RIKEN has established an internal group that is attempting to verify the results of the STAP experiments. The group expects this process to take about a year.

As for dealing with the alleged misconduct, RIKEN said it will allow for an appeal. If the appeal is unsuccessful, the institution will call for the Nature papers to be retracted and take disciplinary action against Dr Obokata.

Drs Sasai and Wakayama may be subject to disciplinary measures as well. RIKEN said that, although the authors are not guilty of research misconduct, they “still bear heavy responsibility for their administrative negligence.”

Image showing

alleged STAP cells

Credit: Haruko Obokata

The Japanese research institute RIKEN has completed its investigation of the research on STAP cells (stimulus-triggered acquisition of pluripotency cells) and claims that study authors are guilty of misconduct and negligence.

According to RIKEN, lead study author Haruko Obokata, PhD, is guilty of misconduct because she manipulated study data.

And 2 other authors—Yoshiki Sasai, MD, PhD, and Teruhiko Wakayama, PhD—should have recognized the data manipulation.

Dr Obokata denied the allegations and said she plans to appeal this judgment. Drs Wakayama and Sasai wrote letters of apology, but Dr Sasai said he still believes the research is valid.

A group of RIKEN researchers has joined other groups in the attempt to replicate Dr Obokata’s experiments and determine if STAP cells can be generated.

About the investigation

RIKEN’s investigation began shortly after Dr Obokata and her colleagues reported the creation of STAP cells. The researchers said they could induce pluripotency by introducing somatic cells to a low-pH environment, and they described this discovery in an article and a letter to Nature.

Not long after the papers were published, members of the scientific community began questioning the validity of the research, citing issues with images, possible plagiarism, and an inability to replicate the experiments described.

So RIKEN launched an investigation into 6 issues with the papers. Early results of the investigation revealed 2 cases of “data mishandling” but no misconduct. And the final results of the investigation suggest 2 of the other issues were simply errors.

However, the 2 remaining issues constituted acts of misconduct, according to RIKEN. In the first case, Dr Obokata switched 1 lane of a diagram for another. She said it was for the purpose of image clarity, but the committee said this change was “intentionally misleading.”

Dr Obokata also used an image of a teratoma from her doctoral thesis (which involved different research). She said she mistakenly used the wrong image, but RIKEN said it was a fraudulent act because the caption on the image had been changed.

Next steps

It is still unclear whether the issues identified affect the results of this research. Dr Obokata and other study authors said the errors do not alter the study’s findings, and creating STAP cells is possible.

Other research groups have attempted to create STAP cells, and most results have suggested it is not possible when using the methods described in the Nature paper (or variations of those methods).

RIKEN has established an internal group that is attempting to verify the results of the STAP experiments. The group expects this process to take about a year.

As for dealing with the alleged misconduct, RIKEN said it will allow for an appeal. If the appeal is unsuccessful, the institution will call for the Nature papers to be retracted and take disciplinary action against Dr Obokata.

Drs Sasai and Wakayama may be subject to disciplinary measures as well. RIKEN said that, although the authors are not guilty of research misconduct, they “still bear heavy responsibility for their administrative negligence.”

Image showing

alleged STAP cells

Credit: Haruko Obokata

The Japanese research institute RIKEN has completed its investigation of the research on STAP cells (stimulus-triggered acquisition of pluripotency cells) and claims that study authors are guilty of misconduct and negligence.

According to RIKEN, lead study author Haruko Obokata, PhD, is guilty of misconduct because she manipulated study data.

And 2 other authors—Yoshiki Sasai, MD, PhD, and Teruhiko Wakayama, PhD—should have recognized the data manipulation.

Dr Obokata denied the allegations and said she plans to appeal this judgment. Drs Wakayama and Sasai wrote letters of apology, but Dr Sasai said he still believes the research is valid.

A group of RIKEN researchers has joined other groups in the attempt to replicate Dr Obokata’s experiments and determine if STAP cells can be generated.

About the investigation

RIKEN’s investigation began shortly after Dr Obokata and her colleagues reported the creation of STAP cells. The researchers said they could induce pluripotency by introducing somatic cells to a low-pH environment, and they described this discovery in an article and a letter to Nature.

Not long after the papers were published, members of the scientific community began questioning the validity of the research, citing issues with images, possible plagiarism, and an inability to replicate the experiments described.

So RIKEN launched an investigation into 6 issues with the papers. Early results of the investigation revealed 2 cases of “data mishandling” but no misconduct. And the final results of the investigation suggest 2 of the other issues were simply errors.

However, the 2 remaining issues constituted acts of misconduct, according to RIKEN. In the first case, Dr Obokata switched 1 lane of a diagram for another. She said it was for the purpose of image clarity, but the committee said this change was “intentionally misleading.”

Dr Obokata also used an image of a teratoma from her doctoral thesis (which involved different research). She said she mistakenly used the wrong image, but RIKEN said it was a fraudulent act because the caption on the image had been changed.

Next steps

It is still unclear whether the issues identified affect the results of this research. Dr Obokata and other study authors said the errors do not alter the study’s findings, and creating STAP cells is possible.

Other research groups have attempted to create STAP cells, and most results have suggested it is not possible when using the methods described in the Nature paper (or variations of those methods).

RIKEN has established an internal group that is attempting to verify the results of the STAP experiments. The group expects this process to take about a year.

As for dealing with the alleged misconduct, RIKEN said it will allow for an appeal. If the appeal is unsuccessful, the institution will call for the Nature papers to be retracted and take disciplinary action against Dr Obokata.

Drs Sasai and Wakayama may be subject to disciplinary measures as well. RIKEN said that, although the authors are not guilty of research misconduct, they “still bear heavy responsibility for their administrative negligence.”

Doctor and patient

Credit: NIH

The US House and Senate have passed a bill that will delay for another year the 24% cut in Medicare reimbursements that was set to take effect April 1 as part of the sustainable growth rate (SGR) formula.

Leaders from the House and Senate recently agreed on a plan to permanently replace the SGR, but they could not agree on a way to pay for it.

The current bill delays the cuts to Medicare reimbursements and extends other expiring healthcare provisions, such as higher payment rates for rural hospitals and ambulance rides in rural areas.

In total, this is expected to cost $21 billion. It will be paid for by cuts to healthcare providers, but half of the cuts won’t take effect for 10 years.

The SGR calls for annual, automatic cuts in Medicare payments to physicians, but these cuts have accumulated over the years. This marks the seventeenth temporary “patch” to the SGR.

For more details on this year’s fix, see the bill: Protecting Access to Medicare Act of 2014 (H.R. 4302).

Doctor and patient

Credit: NIH

The US House and Senate have passed a bill that will delay for another year the 24% cut in Medicare reimbursements that was set to take effect April 1 as part of the sustainable growth rate (SGR) formula.

Leaders from the House and Senate recently agreed on a plan to permanently replace the SGR, but they could not agree on a way to pay for it.

The current bill delays the cuts to Medicare reimbursements and extends other expiring healthcare provisions, such as higher payment rates for rural hospitals and ambulance rides in rural areas.

In total, this is expected to cost $21 billion. It will be paid for by cuts to healthcare providers, but half of the cuts won’t take effect for 10 years.

The SGR calls for annual, automatic cuts in Medicare payments to physicians, but these cuts have accumulated over the years. This marks the seventeenth temporary “patch” to the SGR.

For more details on this year’s fix, see the bill: Protecting Access to Medicare Act of 2014 (H.R. 4302).

Doctor and patient

Credit: NIH

The US House and Senate have passed a bill that will delay for another year the 24% cut in Medicare reimbursements that was set to take effect April 1 as part of the sustainable growth rate (SGR) formula.

Leaders from the House and Senate recently agreed on a plan to permanently replace the SGR, but they could not agree on a way to pay for it.

The current bill delays the cuts to Medicare reimbursements and extends other expiring healthcare provisions, such as higher payment rates for rural hospitals and ambulance rides in rural areas.

In total, this is expected to cost $21 billion. It will be paid for by cuts to healthcare providers, but half of the cuts won’t take effect for 10 years.

The SGR calls for annual, automatic cuts in Medicare payments to physicians, but these cuts have accumulated over the years. This marks the seventeenth temporary “patch” to the SGR.

For more details on this year’s fix, see the bill: Protecting Access to Medicare Act of 2014 (H.R. 4302).

DNA helices

Credit: NIGMS

NASHVILLE—New research suggests we may need to use more sensitive methods to analyze patients with cytogenetically normal acute myeloid leukemia or myelodysplastic syndrome (CN-AML/MDS).

Using “highly sensitive” microarray technology, researchers found a distinct pattern of genetic abnormalities in 22 patients diagnosed with CN-AML/MDS.

The team identified 3 overlapping regions of homozygosity in 3 genes, 2 of which are known to be involved in carcinogenesis.

This suggests that using karyotyping or FISH, or simply looking for known mutations, is not sufficient for evaluating patients with CN-AML/MDS, according to Ravindra Kolhe, MD, PhD, of the Medical College of Georgia at Georgia Regents University.

“The technology we currently use can’t identify specifically what’s wrong,” Dr Kolhe said. “We have to use more sensitive tests to give patients the proper answer.”

Dr Kolhe presented this finding, and the research to support it, at the American College of Medical Genetics and Genomics Annual Clinical Genetics Meeting.

He and his colleagues analyzed 22 patients. Seventeen had AML, and 5 had MDS, including 1 with refractory anemia with excess blasts-2. All patients had normal karyotype and FISH and had greater than 20% blasts in the bone marrow.

The researchers analyzed samples from these patients using a high-resolution, single-nucleotide polymorphism (SNP) microarray called CytoScanHD.

According to the company that markets this technology (Affymetrix, Inc.), the assay includes 750,000 SNPs with over 99% accuracy to detect accurate breakpoint estimation, loss of heterozygosity determination, regions identical-by-descent, maternal contamination, and low-level mosaicism.

For Dr Kolhe and his colleagues, the assay revealed small, previously undetectable changes in patients thought to be cytogenetically normal.

Specifically, the researchers identified 3 overlapping regions of homozygosity in all 22 cases—chromosome 1p34.3, chromosome 1p32.3, and chromosome 16q22.1 in the SFPQ, EPS15, and CTCF genes, respectively.

SFPQ and CTCF are already known to be involved in carcinogenesis, and Dr Kolhe and his colleagues are now investigating the role of EPS15 in leukemogenesis.

The researchers also identified additional abnormalities and are investigating these as well. They are sequencing the genes to identify homozygous or compound heterozygous mutations, performing expression studies to confirm that these mutations are leukemic, and conducting experiments in knockout mice to demonstrate that these genes produce the same leukemia phenotype.

The materials and reagents for this study were provided by Affymetrix. The test design, experimentation, data collection, analysis, and interpretation were done independently by the researchers.

DNA helices

Credit: NIGMS

NASHVILLE—New research suggests we may need to use more sensitive methods to analyze patients with cytogenetically normal acute myeloid leukemia or myelodysplastic syndrome (CN-AML/MDS).

Using “highly sensitive” microarray technology, researchers found a distinct pattern of genetic abnormalities in 22 patients diagnosed with CN-AML/MDS.

The team identified 3 overlapping regions of homozygosity in 3 genes, 2 of which are known to be involved in carcinogenesis.

This suggests that using karyotyping or FISH, or simply looking for known mutations, is not sufficient for evaluating patients with CN-AML/MDS, according to Ravindra Kolhe, MD, PhD, of the Medical College of Georgia at Georgia Regents University.

“The technology we currently use can’t identify specifically what’s wrong,” Dr Kolhe said. “We have to use more sensitive tests to give patients the proper answer.”

Dr Kolhe presented this finding, and the research to support it, at the American College of Medical Genetics and Genomics Annual Clinical Genetics Meeting.

He and his colleagues analyzed 22 patients. Seventeen had AML, and 5 had MDS, including 1 with refractory anemia with excess blasts-2. All patients had normal karyotype and FISH and had greater than 20% blasts in the bone marrow.

The researchers analyzed samples from these patients using a high-resolution, single-nucleotide polymorphism (SNP) microarray called CytoScanHD.

According to the company that markets this technology (Affymetrix, Inc.), the assay includes 750,000 SNPs with over 99% accuracy to detect accurate breakpoint estimation, loss of heterozygosity determination, regions identical-by-descent, maternal contamination, and low-level mosaicism.

For Dr Kolhe and his colleagues, the assay revealed small, previously undetectable changes in patients thought to be cytogenetically normal.

Specifically, the researchers identified 3 overlapping regions of homozygosity in all 22 cases—chromosome 1p34.3, chromosome 1p32.3, and chromosome 16q22.1 in the SFPQ, EPS15, and CTCF genes, respectively.

SFPQ and CTCF are already known to be involved in carcinogenesis, and Dr Kolhe and his colleagues are now investigating the role of EPS15 in leukemogenesis.

The researchers also identified additional abnormalities and are investigating these as well. They are sequencing the genes to identify homozygous or compound heterozygous mutations, performing expression studies to confirm that these mutations are leukemic, and conducting experiments in knockout mice to demonstrate that these genes produce the same leukemia phenotype.

The materials and reagents for this study were provided by Affymetrix. The test design, experimentation, data collection, analysis, and interpretation were done independently by the researchers.

DNA helices

Credit: NIGMS

NASHVILLE—New research suggests we may need to use more sensitive methods to analyze patients with cytogenetically normal acute myeloid leukemia or myelodysplastic syndrome (CN-AML/MDS).

Using “highly sensitive” microarray technology, researchers found a distinct pattern of genetic abnormalities in 22 patients diagnosed with CN-AML/MDS.

The team identified 3 overlapping regions of homozygosity in 3 genes, 2 of which are known to be involved in carcinogenesis.

This suggests that using karyotyping or FISH, or simply looking for known mutations, is not sufficient for evaluating patients with CN-AML/MDS, according to Ravindra Kolhe, MD, PhD, of the Medical College of Georgia at Georgia Regents University.

“The technology we currently use can’t identify specifically what’s wrong,” Dr Kolhe said. “We have to use more sensitive tests to give patients the proper answer.”

Dr Kolhe presented this finding, and the research to support it, at the American College of Medical Genetics and Genomics Annual Clinical Genetics Meeting.

He and his colleagues analyzed 22 patients. Seventeen had AML, and 5 had MDS, including 1 with refractory anemia with excess blasts-2. All patients had normal karyotype and FISH and had greater than 20% blasts in the bone marrow.

The researchers analyzed samples from these patients using a high-resolution, single-nucleotide polymorphism (SNP) microarray called CytoScanHD.

According to the company that markets this technology (Affymetrix, Inc.), the assay includes 750,000 SNPs with over 99% accuracy to detect accurate breakpoint estimation, loss of heterozygosity determination, regions identical-by-descent, maternal contamination, and low-level mosaicism.

For Dr Kolhe and his colleagues, the assay revealed small, previously undetectable changes in patients thought to be cytogenetically normal.

Specifically, the researchers identified 3 overlapping regions of homozygosity in all 22 cases—chromosome 1p34.3, chromosome 1p32.3, and chromosome 16q22.1 in the SFPQ, EPS15, and CTCF genes, respectively.

SFPQ and CTCF are already known to be involved in carcinogenesis, and Dr Kolhe and his colleagues are now investigating the role of EPS15 in leukemogenesis.

The researchers also identified additional abnormalities and are investigating these as well. They are sequencing the genes to identify homozygous or compound heterozygous mutations, performing expression studies to confirm that these mutations are leukemic, and conducting experiments in knockout mice to demonstrate that these genes produce the same leukemia phenotype.

The materials and reagents for this study were provided by Affymetrix. The test design, experimentation, data collection, analysis, and interpretation were done independently by the researchers.

A Rough Patch

I was the medical director of a hospitalist group in the Southeast that had been hospital-owned for eight years and grew to more than 20 full-time providers. New hospital administrators took over and, faced with staffing and compensation issues, outsourced the program. Within a year, all but one of the HMG employees (physicians, nurse practitioners, and physician assistants) resigned. As expected, the exodus put a strain on the program, patient care, and community. After a shakeup in administration, the management company pulled out. The hospital now runs the HM program. Is this occurrence just an outlier or are thes kind of situations becoming common to our field?

—Dr. Nore-grets

Dr. Hospitalist responds:

While I’m saddened at the disruption of so many lives (hospital executives, physicians, advanced practice providers, other clinical staff, and patients), I must say I’m not surprised by the outcome. Hospital medicine continues to be a rapidly growing specialty; approximately 70% of all hospitals in the U.S. have a hospitalist program. It’s only 17 years old, and as with all adolescents still finding their way, disputes are common.

Like most good stories, there are usually two sides. Hospitals have a board to satisfy, large numbers of employees (professional and non-professional), varying revenue streams to contend with, and an annual budget. There are many different groups vying for a larger slice of the pie—and the pie is only so big. No matter how we see it, some administrators believe physicians are overpaid and are not hard workers. There may not be much empathy for the docs, who work "only 182 days a year," asking for more time off, paid vacations, smaller patient loads, and more money.

Physicians see their student loans stretched out for 30 years, hospitals on building sprees, heavy patient loads, complex administrative tasks, and a lack of appreciation for the myriad intangible and non-billable services they render every day. Not being able to take a paid vacation like most workers in this country seems unfair to many. Even though most hospitalists still work 12-hour shifts, we resist being labeled "shift workers" because of the negative and non-professional inference.

It appears your hospitalist group had concerns about staffing and pay, and instead of effectively dealing with their concerns, the hospital’s administrators decided to outsource the program. While most national firms that hire hospitalists are well intentioned, they (like most hospitals) are driven by profit and sometimes bring in transient and inexperienced physicians. The eight-year-old group, while still relatively young, likely had members who had established both personal and professional relationships with many of the physicians and other clinical staff. These relationships, when built on trust, mutual respect, and competence, are the foundation of good clinical care. It is no surprise they were not able to adequately replace the clinicians who resigned.

The issues of pay and staffing are common points of contention among hospitalist and hospital administrators. The mode of compensation most often used is based on hospitalist productivity and is heavily subsidized by the hospital. While this model has served us well, the passage of the Affordable Care Act will change how healthcare systems are reimbursed. There will likely be many instances of bundled payments tied to inpatient care, but also an opportunity for hospitalists to further expand their roles into improving the quality of care and efficiency of delivery. The formation of accountable care organizations will offer even more opportunities for physician leadership and organizational assistance. The more hospitalists become imbedded in and invaluable to the hospital, the less likely we are placed on the chopping block when budget cuts happen or leadership changes (as in your case).

Until the reimbursement model changes, both groups need to understand the other’s position and use some basis for comparative analysis. I find the information from SHM surveys serves as a good basis to initiate discussion and allows for transparency. As in any negotiation, a shared sense of responsibility, goodwill, and commitment is necessary to find a just solution.

Because HM continues its rapid growth and hospitalists are in such high demand, many in the group are not tolerant of what they perceive as unfair treatment or pay. The principles of supply and demand economics are at work and have so far benefitted hospitalists well. We must balance our desire for just pay and fair staffing models with our responsibility as clinicians to care for the injured and heal the sick.

A Rough Patch

I was the medical director of a hospitalist group in the Southeast that had been hospital-owned for eight years and grew to more than 20 full-time providers. New hospital administrators took over and, faced with staffing and compensation issues, outsourced the program. Within a year, all but one of the HMG employees (physicians, nurse practitioners, and physician assistants) resigned. As expected, the exodus put a strain on the program, patient care, and community. After a shakeup in administration, the management company pulled out. The hospital now runs the HM program. Is this occurrence just an outlier or are thes kind of situations becoming common to our field?

—Dr. Nore-grets

Dr. Hospitalist responds:

While I’m saddened at the disruption of so many lives (hospital executives, physicians, advanced practice providers, other clinical staff, and patients), I must say I’m not surprised by the outcome. Hospital medicine continues to be a rapidly growing specialty; approximately 70% of all hospitals in the U.S. have a hospitalist program. It’s only 17 years old, and as with all adolescents still finding their way, disputes are common.

Like most good stories, there are usually two sides. Hospitals have a board to satisfy, large numbers of employees (professional and non-professional), varying revenue streams to contend with, and an annual budget. There are many different groups vying for a larger slice of the pie—and the pie is only so big. No matter how we see it, some administrators believe physicians are overpaid and are not hard workers. There may not be much empathy for the docs, who work "only 182 days a year," asking for more time off, paid vacations, smaller patient loads, and more money.

Physicians see their student loans stretched out for 30 years, hospitals on building sprees, heavy patient loads, complex administrative tasks, and a lack of appreciation for the myriad intangible and non-billable services they render every day. Not being able to take a paid vacation like most workers in this country seems unfair to many. Even though most hospitalists still work 12-hour shifts, we resist being labeled "shift workers" because of the negative and non-professional inference.

It appears your hospitalist group had concerns about staffing and pay, and instead of effectively dealing with their concerns, the hospital’s administrators decided to outsource the program. While most national firms that hire hospitalists are well intentioned, they (like most hospitals) are driven by profit and sometimes bring in transient and inexperienced physicians. The eight-year-old group, while still relatively young, likely had members who had established both personal and professional relationships with many of the physicians and other clinical staff. These relationships, when built on trust, mutual respect, and competence, are the foundation of good clinical care. It is no surprise they were not able to adequately replace the clinicians who resigned.

The issues of pay and staffing are common points of contention among hospitalist and hospital administrators. The mode of compensation most often used is based on hospitalist productivity and is heavily subsidized by the hospital. While this model has served us well, the passage of the Affordable Care Act will change how healthcare systems are reimbursed. There will likely be many instances of bundled payments tied to inpatient care, but also an opportunity for hospitalists to further expand their roles into improving the quality of care and efficiency of delivery. The formation of accountable care organizations will offer even more opportunities for physician leadership and organizational assistance. The more hospitalists become imbedded in and invaluable to the hospital, the less likely we are placed on the chopping block when budget cuts happen or leadership changes (as in your case).

Until the reimbursement model changes, both groups need to understand the other’s position and use some basis for comparative analysis. I find the information from SHM surveys serves as a good basis to initiate discussion and allows for transparency. As in any negotiation, a shared sense of responsibility, goodwill, and commitment is necessary to find a just solution.

Because HM continues its rapid growth and hospitalists are in such high demand, many in the group are not tolerant of what they perceive as unfair treatment or pay. The principles of supply and demand economics are at work and have so far benefitted hospitalists well. We must balance our desire for just pay and fair staffing models with our responsibility as clinicians to care for the injured and heal the sick.

A Rough Patch

I was the medical director of a hospitalist group in the Southeast that had been hospital-owned for eight years and grew to more than 20 full-time providers. New hospital administrators took over and, faced with staffing and compensation issues, outsourced the program. Within a year, all but one of the HMG employees (physicians, nurse practitioners, and physician assistants) resigned. As expected, the exodus put a strain on the program, patient care, and community. After a shakeup in administration, the management company pulled out. The hospital now runs the HM program. Is this occurrence just an outlier or are thes kind of situations becoming common to our field?

—Dr. Nore-grets

Dr. Hospitalist responds:

While I’m saddened at the disruption of so many lives (hospital executives, physicians, advanced practice providers, other clinical staff, and patients), I must say I’m not surprised by the outcome. Hospital medicine continues to be a rapidly growing specialty; approximately 70% of all hospitals in the U.S. have a hospitalist program. It’s only 17 years old, and as with all adolescents still finding their way, disputes are common.

Like most good stories, there are usually two sides. Hospitals have a board to satisfy, large numbers of employees (professional and non-professional), varying revenue streams to contend with, and an annual budget. There are many different groups vying for a larger slice of the pie—and the pie is only so big. No matter how we see it, some administrators believe physicians are overpaid and are not hard workers. There may not be much empathy for the docs, who work "only 182 days a year," asking for more time off, paid vacations, smaller patient loads, and more money.

Physicians see their student loans stretched out for 30 years, hospitals on building sprees, heavy patient loads, complex administrative tasks, and a lack of appreciation for the myriad intangible and non-billable services they render every day. Not being able to take a paid vacation like most workers in this country seems unfair to many. Even though most hospitalists still work 12-hour shifts, we resist being labeled "shift workers" because of the negative and non-professional inference.

It appears your hospitalist group had concerns about staffing and pay, and instead of effectively dealing with their concerns, the hospital’s administrators decided to outsource the program. While most national firms that hire hospitalists are well intentioned, they (like most hospitals) are driven by profit and sometimes bring in transient and inexperienced physicians. The eight-year-old group, while still relatively young, likely had members who had established both personal and professional relationships with many of the physicians and other clinical staff. These relationships, when built on trust, mutual respect, and competence, are the foundation of good clinical care. It is no surprise they were not able to adequately replace the clinicians who resigned.

The issues of pay and staffing are common points of contention among hospitalist and hospital administrators. The mode of compensation most often used is based on hospitalist productivity and is heavily subsidized by the hospital. While this model has served us well, the passage of the Affordable Care Act will change how healthcare systems are reimbursed. There will likely be many instances of bundled payments tied to inpatient care, but also an opportunity for hospitalists to further expand their roles into improving the quality of care and efficiency of delivery. The formation of accountable care organizations will offer even more opportunities for physician leadership and organizational assistance. The more hospitalists become imbedded in and invaluable to the hospital, the less likely we are placed on the chopping block when budget cuts happen or leadership changes (as in your case).

Until the reimbursement model changes, both groups need to understand the other’s position and use some basis for comparative analysis. I find the information from SHM surveys serves as a good basis to initiate discussion and allows for transparency. As in any negotiation, a shared sense of responsibility, goodwill, and commitment is necessary to find a just solution.

Because HM continues its rapid growth and hospitalists are in such high demand, many in the group are not tolerant of what they perceive as unfair treatment or pay. The principles of supply and demand economics are at work and have so far benefitted hospitalists well. We must balance our desire for just pay and fair staffing models with our responsibility as clinicians to care for the injured and heal the sick.