13 Jun

Full House for PeriGen Reception @ AWHONN

Short Stories of OB Malpractice

Full House for

“Short Stories of OB Malpractice &

How They Might

Have Been Avoided

Stephen Brzezinski, a leading OB malpractice defense attorney from Kitch, Drutchas Wagner Valitutti & Sherbrook, and Emily Hamilton, PeriGen Senior Vice President of Clinical Research presented to a packed house of labor & delivery directors, clinicians, educators, and risk managers last night at the AWHONN Convention in Grapevine, Texas.

The invitation-only presentation focused on factors leading to OB malpractice complaints as well as recent malpractice actions involving labor & delivery clinicians and offered practice strategies and discussion on how they might have been avoided.

Presentation slides are now available here

PeriGen is also exhibiting at the AWHONN Convention (Booth 615), where the event team will be offering demonstrations of the latest features of the PeriCALM obstetric decision support system, an electronic fetal monitoring (EFM) system that provides “safety net” benefits for labor & delivery clinical teams.

PeriGen is dedicated to helping prevent OB malpractice by providing enriched data that support clinical decisions at the bedside, at the nurses station and to providers remotely.

09 Jun

We Can Do Better

We Can Do Better

Recent research finds medical error third leading cause of death in USBy Matthew Sappern, CEO, PeriGen

Earlier this month, the well respected, widely read British Medical Journal published a scary study coming out of Johns Hopkins. Entitled Medical Error, the Third Leading Cause of Death in the US,  it immediately sparked debate in many corners as to the veracity of the data, the precision of the study, the complexity and limitations of actually compiling and analyzing this information. I’ll leave that to others – I see a blunt message here: We Can Do Better.

To me, this is not so much a question of enhanced training or personnel or protocols. Humans excel at critical thinking, but there will always be a “Human Factor” to manage – those few instances where a human misses something. This study begs the question “are there tools that can help clinicians at the bedside – patient by patient?” How can we best leverage technology to augment caregivers?

As you all know better than I, the clinical setting is challenging! At the labor and delivery bedside, nurses are monitoring and documenting several aspects of the labor, interacting and calming the patient, managing the patient’s family (Nurse Luisa, I apologize again for asking the same questions every five minutes 12 years ago), keeping the rest of the care team informed. All while looking for what might be faint indications of an intervention needed.

Fortunately, PeriGen customers have at their disposal some of the most advanced tools in the world to help share the load. PeriGen systems help count and calculate critical factors, providing a safety net for L&D clinicians and the world’s most precious patients. Other specialties in the hospital should take note of the great work that PeriGen users are delivering.

03 Jun

AI will always need humans

Watson and His AI Cousins Will

Always Need Humans:

AI will always need humans

Is the Converse True?

by Emily Hamilton
Senior Vice President, PeriGen

Most of us will easily concede that computers are better at number crunching than humans. How many of us, even in our prime, can quickly complete the dreaded serial sevens test? (counting down from one hundred by sevens, a clinical test used to test mental status) .

As for higher level functions like reasoning, clinical judgment, strategic planning, creativity, empathy surely these are better achieved by humans. Well yes, but maybe not always.

This year Google’s AlphaGo defeated a human champion at the ancient game of Go, not by brute force (calculating the best of every possible move at each turn) but by using deep neural networks to learn successful and efficient strategies. AlphaGo learned its strategies by playing the game. With modern computational capacity AlphaGo was able to play more games in a day and that a human could play in a decade. Furthermore, it could remember that experience!

Chess is not medicine. What does the evidence show in medicine?

In 1954 the acclaimed psychologist Paul E. Meehl began a debate that would last more than half a century when he compared the accuracy of clinical versus statistical methods to predict patient condition.(1) His analysis, described in the book Clinical vs. Statistical Prediction: A Theoretical Analysis and a Review of the Evidence, concluded that statistical   (e.g., explicit equations, actuarial tables, defined algorithmic prediction) outperformed clinical methods (e.g., subjective, informal, reasoning, clinical intuition).

Later in 2000, Grove et al published a comprehensive analysis of relevant publications on man versus machine methods. (2)  Their meta-analysis included 136 published reports and compared performance of clinical and statistical methods in a wide variety of domains. Their results confirmed the findings of Meehl! Statistical methods outperformed clinical methods again.

They reported that better performance with statistical methods held across subject matter (medical, mental health, forensic, academic performance ) although the advantage was greatest in the forensic domains. The level of clinician experience did not make a difference, even when the statistical methods were compared to the best performing clinician(s). Superior results were not entirely uniform.   In about half of the studies the difference was small and the clinical methods were approximately the same as the statistical methods. In about one third, the statistical methods substantially outperformed clinicians especially when clinical interviews were involved. That is, detection rates were higher by about 10% or more for predictions with intermediate accuracy. In a small minority, 6% of the studies, the clinical methods were better.

In 2006, Hilton et al reported similar findings and noted a widening gap between statistical and clinical methods when reviewing 66 years of research on the prediction of violence. (3) Reports in current medical literature differ somewhat. A recent review by Sanders et al showed more equivalence between clinical methods and statistical prediction using a wider variety of assessment measures.   Only 31 studies met their inclusion criteria highlighting both the relative scarcity of complex statistical techniques in clinical use and the scientific inadequacy of the comparison methods.(4)

There are many reasons to believe that clinical judgement is better today than in previous eras

Our basic understanding of disease has improved. We have better laboratory tests and higher standards for medical evidence and easier access to information. In fact, one could argue that the clinician today has better access and better information compared to many years ago when there were few genetic markers, biomarkers and environmental conditions to consider. In fact, we may have too much information. The very same mental processes that are essential to “size up” a situation efficiently in the face of so much information can also result in erroneous decisions on occasion.

Two well-established psychological phenomena bear special mention in any discussion of medical error. Recent events or vivid anecdotes form strong and highly influential memories that can distort our perception of the real incidence or usual consequences of specific scenarios. Tunnel vision refers to the tendency to perceive and confirm information that aligns with a particular viewpoint. It includes Framing bias – the tendency to create a coherent interpretation without examining all available information and Confirmation bias which refers to seeking only the information that supports a particular opinion. Finally, too much information can actually obscure critical information. These biases and the burden of too much information are not so problematic for statistical methods.

Pitting clinical methods against computer based methods is unrealistic. “Medical reasoning” and “statistical algorithms” are both derived from real clinical data   Moreover, clinicians incorporate statistical methods unconsciously when reasoning.   They consider the background general incidence of the condition, typical constellations of signs and symptoms and weigh the pros and cons of potential diagnosis and treatments. Many clinicians know and use scoring systems which are essentially simplified statistical weighting methods. Statistics is but a formalized mathematical way to analyze real data and then summarize it succinctly to help us make inferences. Thus one would expect performance measures of human and clinicians to converge.

Mark Twain is often credited with writing – “Facts are stubborn things, statistics are more pliable”. But in this context, clinicians are more pliable. Clinicians can obtain and integrate information from additional sources, see exceptions to the rules, factor in patient fears and desires and even make do with missing data. Clinicians communicate with patients, reason and have empathy. However, occasionally they get tired, take risky shortcuts and must deal with competing interests. In contrast, statistical facts are stubborn things and not subject to the effects of fatigue or recent experience. At present they are not very communicative nor empathetic. Robotic companions for seniors may change our opinion.

The strengths of human and statistical methods are complementary

The objective unbiased statistical methods help to counter the potential for human bias, reduce information overload and help the seasoned clinician make more confident decisions.   The idea of a clear division between clinical reasoning and statistical methods is becoming increasing blurred. The good news is that the best is yet to come and it will probably arrive on your phone.

  1. Meehl, P.E. (1954). Clinical versus statistical prediction: A theoretical analysis and a review of the evidence. Minneapolis: University of Minnesota
  2. Grove WM, Zald DH, Lebow BS, Snitz BE, Nelson C. Clinical versus mechanical prediction: a meta-analysis. Psychol Assess. 2000 ;12(1):19-30
  3. Hilton NZ, Harris GT, Rice ME, Sixty-Six Years of Research on the Clinical Versus Actuarial Prediction of Violence. The Counseling Psychologist, 2006 ; 34(3):400-409.
  4. Sanders S, Doust J, Glasziou P. A systematic review of studies comparing diagnostic clinical prediction rules with clinical judgment. PLoS One. 2015 Jun 3;10(6):e0128233.
  5. Lee YH, Bang H, Kim DJ. How to Establish Clinical Prediction Models. Endocrinol Metab (Seoul). 2016 Mar;31(1):38-44.
05 Apr

Annual Obstetric Malpractice Review

MalpracticeEvery year, according to a study published by The New England Journal of Medicine in 2011, just over 11% of obstetricians and the hospitals and clinicians serving them, will be faced with malpractice complaints. The average payout will be approximately $360,000 with significant state-by-state variation.¹

PeriGen’s Annual Review of
Labor & Delivery Malpractice Awards

Following is a summary of 2015 perinatal malpractice awards, settlements and complaints:

    • $8.4 Million Awarded for Hypoxic Ischemic Brain Injury:   Mother was admitted to the a Georgia medical center for delivery of a full-term baby. The labor continued throughout the evening.  Baby was delivered around noon the next day. Her admitting physician was not present at the delivery, but delivery was overseen by a CNM. For several hours prior to the delivery, fetal heart rate was noted as decelerating and variable. Infant was born severely depressed, with low APGAR scores and metabolic acidosis. He was not intubated for 8 minutes, and he continued to deteriorate, a full code ensued, and resuscitation occurred. Ultimately, infant was diagnosed with a hypoxic ischemic brain injury and developed cerebral palsy. Click for details
    • A Michigan court granted the right to appeal for a case stemming from a 2008 delivery outcome.  Mother  was admitted to the hospital with ruptured membranes. She had a lengthy labor – 29 hours – augmented by the drug Pitocin.  The baby failed to descend after two hours of pushing. The mother had developed chorioamnionitis (placental infection) and the doctors noticed the presence of meconium. The labor was terminated with a caesarian section. Records revealed “delivery of a healthy baby boy who weighed 9 lbs 13 oz. However, the infant began to show signs of seizing shortly after his birth and a CT scan revealed an acute left middle cerebral artery ischemic stroke, which was “days to hours old.” The complaint alleged that “[t]he baby was at risk for, and did develop, brain injury from traumatic head compression and regional cerebral ischemia caused by failure to descend, macrosomia (large baby), excessive contractions in the presence of failure of descent as augmented with oxytocin, hypoxia-ischmeia (regional cerebral and/or systemic) caused by uteroplacental insufficiency and by cord compression and head compression.” The complaint alleged that defendants were negligent in administering oxytocin, in failing to properly respond to fetal heart rate changes, and in failing to perform a timely c-section. Click for details
    • A couple in Puerto Rico filed a suit for $27 million against two hospitals as a result of respiratory failure, perinatal asphyxia, and clinical sepsis. After experiencing pelvic pressure and secretions the mother was admitted without contractions or amniotic rupture. The mother underwent induced labor. Upon birth, the newborn was found  to be in critical condition. His skin was blue from poor circulation, and he did not respond to any external stimuli.  The boy was rushed to NICU and hooked up to a mechanical ventilator. He was diagnosed with respiratory failure, perinatal asphyxia, and clinical sepsis. After nearly a month of care, the boy was released from treatment. Then in January 2013 doctors diagnosed him with multicystic leukoencephalopathy and microcephaly, from which stemmed a host of motor, mental, and sensory complications, such as seizures and impaired vision and hearing. Click to review case
    • A New Jersey family realized a $700,000 malpractice settlement as a result of a Erbs palsy brachial plexus injury.  The case contends that the attending physician used excessive traction during  delivery, resulting in stretching and tearing of the brachial plexus. See details
    • Another settlement, this one for $562,500 followed a complaint that the obstetrician and nurse, monitoring a patient in labor, failed to recognize that the infant’s heart rate had slowed when the fetal monitor strips was actually demonstrating the mother’s heart rate. The mother’s uterus had abrupted, causing a lack of blood flow and oxygen to the baby. By the time the error was recognized, the infant had died from lack of oxygen.  Details provided here
    • Hypoxic ischemic encephalopathy (HIE) with extensive brain injury is the subject of a recent medical malpractice claim brought against a military hospital in the District of Columbia. The complaint states that after being admitted to the medical center in the early stages of labor, the plaintiff was given oxytocin to help augment contractions. Subsequent fetal heart monitoring suggested an abnormally high rate of contractions, but augmentation was continued. Following this, medical records indicated an increase in the fetal heart baseline along with intermittent late decelerations. Shortly thereafter, the mother developed a fever and was diagnosed with chorioamnionitis (a bacterial infection of the fetal membranes). After several hours of prolonged labor, the plaintiff was delivered, at which point shoulder dystocia was noted.  Allegedly, a first year resident then unsuccessfully attempted to relieve the shoulder dystocia with downward pressure. Next, a third-year resident tried several maneuvers to free the baby’s shoulder, including the McRoberts maneuver, the Rubin maneuver and others. All were ineffective. At this point, contends the complaint, the attending obstetrician arrived and was able to successfully free the shoulder allowing for a vaginal delivery. Upon delivery, the plaintiff’s little girl was was described as having bruising on the face and scalp, a fractured right clavicle and Erb’s palsy. She was also hypotonic and experienced seizures. About five days after her birth an MRI revealed that the child showed hypoxic ischemic encephalopathy with extensive brain trauma. See more
    • Honolulu based hospital faced with $9,000,000 obstetric settlement:  The mother arrived at the hospital at 35 weeks into her pregnancy, she had severe lower abdominal pain. Because of her previous history of miscarriage and the complicated delivery of her first child, the mother had undergone a procedure to keep her uterus closed until delivery and the pregnancy was under close supervision. However, when she arrived at the hospital, the hospital failed to notify and consult her obstetrician. An emergency C-section was performed, but the complaint contends that the procedure was not performed in time to prevent reduced oxygen flow to the fetal brain, causing brain damage. Click for more information
    • A $5 million suite filed against a military hospital in Kentucky also results from HIE. The suit contends that connected to a fetal heart rate monitor, the healthcare workers failed to properly monitor and interpret the tracings. The plaintiff claims that the medical records indicate her daughter was in respiratory failure for a long period of time. In addition, the complaint states that, despite knowing that the labor was not progressing properly, healthcare providers failed to perform a cesarean section. The newborn was diagnosed with intracerebral hemorrhage and interventricular hemorrhage. Click for details

 

¹Anupam B. Jena, M.D., Ph.D., Seth Seabury, Ph.D., Darius Lakdawalla, Ph.D., and Amitabh Chandra, Ph.D. Malpractice Risk According to Physician Specialty N Engl J Med 2011; 365:629-636

23 Mar

HIStalk interviews CEO Matt Sappern

Matthew Sappern is PeriGen's Chief Executive Officer“The Safest Place to
Have a Baby”

PeriGen CEO Matt Sappern shares an anecdote about his time at this year’s HIMMS conference.  Seems that a client CIO made quite an impression on those manning the booth of a major EHR vendor when he proclaimed that PeriGen was helping make his hospital be the safest place to have a baby.

Matt closes the interview with another great story about a cesarean avoided through PeriCALM’s power of delivering the right information in real-time at the bedside

Read the Inteview

15 Mar

Perinatal Webinar Summary for Tomorrow

Better perinatal assessment of fetal heart rate patterns

Here’s a summary of what Emily Hamilton, MDCM will be covering during tomorrow’s free perinatal nursing training webinar designed to help clinicians improve their ability to understand FHR variation and decelerations.

  • What regulates the fetal heart rate
  • Fetal heart rate decelerations
  • Variable decelerations
  • Late decelerations
  • How they affect clinical interpretation of tracings

Perinatal Training Summary:

The clinical goal of electronic fetal monitoring is to identify fetuses with increased risk of hypoxic injury so that intervention can be executed to avoid adverse outcomes without also causing excessive number of interventions.  Understanding the mechanisms of fetal heart rate control is important because it can help us to infer the physiological state of the baby and gauge whether intervention is truly necessary.

Unlike in adult cardiology, where ECG changes are used to diagnose myocardial infarction, labor & delivery clinicians depend upon the heart rate to infer the condition of another organ, namely the fetal brain.  Although the fetal heart rate is related to fetal brain state, is is also affected by a number of other factors.

During tomorrow’s training webinar, Dr. Hamilton will provide an overview of recent perinatal research on these factors.

Registration is still open, but “seats” are filling fast

Register now by completing form below

14 Mar

Discuss EFM data vs clinical information

Are you using just data or rich clinical information to assess labor?

Here’s a definition of data

According to Merriam-Webster’s dictionary, data is the output from a sensing device that includes both useful and relevant or redundant information and must be processed to be meaningful.

Typical perinatal EFM software provides labor data

Here’s a familiar example:
Traditional electronic fetal monitoring systems, developed long before computers made real-time analysis possible in a hospital setting, deliver numeric measurements of fetal heart rate and contractions and presents them in graph form.

Converting this obstetric data to information of actual use is left entirely up to clinicians in their role as human calculators.

Here’s a definition of clinical information

Knowledge obtained from investigation, study, or instruction which justifies change in a plan or theory.

Perinatal Clinical Information fuels better childbirth decision-making

Information-rich decision support tools, illustrated in the PeriCALM® screenshot shown above, convert data into intelligence that make more robust interpretation and decision-making possible.

How many perinatal nurses are limited to just using data to assess labor?

Does your EFM software system deliver data or information?

Which is of more use?  How would having the rich clinical information shown above make a difference with your work?

10 Mar

Free L&D Training Session

Register for WebinarThe following is this week’s excerpt from The Physiology of EFM.  Hear author Emily Hamilton review the entire contents of this white paper during the free online training webinar designed for labor & delivery clinicians on March 16th (Noon – 12:30 PM ET).

Register today for free L&D training session
The Physiology of EFM

Wednesday, March 16th
Noon – 12:30 PM ET

Fetal Heart Rate Variability

Current clinical guidelines that classify tracings rely heavily on reduced baseline heart rate variability as an indicator of significant acidosis and/or need for intervention.6-12 Minimal variability, especially when it persists and is accompanied by decelerations, is associated with marked acidemia, low Apgar scores and hypoxic injury.

Minimal variability, especially when it persists and is accompanied by decelerations, is associated with marked acidemia, low Apgar scores and hypoxic injury.

All of the mechanisms controlling fetal heart rate depicted in Figure 1 influence heart rate variability. Fetal behavioral states, breathing and movements affect heart rate variability acting though the central pathways to the medulla, and then to the heart via the sympathetic and parasympathetic systems. Fetal heart rate variability is suppressed by factors that depress fetal brain function.

Animal experiments have shown that blockage of the parasympathetic system with atropine results in a reduction in short-term variability.13 A reduction in long-term variability occurs after sympathetic blockade.14, 15 Fetal heart rate variability is more than the simple “push-pull” interactions between the inhibitory and acceleratory limbs of the autonomic nervous system. The heart itself contributes to variability. Even with complete double blockade of the sympathetic and parasympathetic systems, around 35-40% of fetal lamb heart rate variability persists.13 A clinical demonstration of the intrinsic rhythmicity of the heart is found in transplantation surgery. An excised heart continues to beat and demonstrate heart rate variability.

Marked variability may be a sign of activation of compensatory pathways.

The association between variability and metabolic acidosis is less clear. This is important because all contemporary EFM classification methods place high reliance upon baseline fetal heart rate variability to exclude the presence of metabolic acidosis.6-12 The 2008 NICHD Update publication in which the Category I, II, III classification method was first described includes a statement that “moderate variability reliably predicts the absence of metabolic acidemia at the time that it is observed.”6 This concept was softened in the 2009 ACOG Practice Bulletin 106 with the statement “The data relating FHR variability to clinical outcomes, however, are sparse.”7 This practice bulletin endorsed the 3-level categorization of tracings where the third level required absent baseline variability.

The 2010 ACOG Practice Bulletin 116 presented a clinical management algorithm with high reliance on moderate variability.8 In this management algorithm, the recommendations for tracings in Category 2 were continued surveillance and intrauterine resuscitation measures, as long as there was moderate variability. Only a failure to respond to intrauterine resuscitative measures in the presence of absent or minimal variability lead to the recommendation of “consideration of delivery” for Category II tracings.

There is a growing body of literature that does not support the statement that moderate variability reliably excludes the presence of metabolic acidemia.

In animal studies, vascular instrumentation allows for blood gas measurement at any specific time to be correlated with the coexisting fetal heart rate features. Martin demonstrated that in sheep the initial fetal heart rate response to sudden hypoxemia was a slowing of the heart rate with increased variability.1 Others observed similar changes in sheep and in monkeys.16-18 Field et al found initial decreases in heart rate variability with iliac occlusion in sheep, but variability returned to normal by 36 minutes despite worsening metabolic acidosis.19 These observations of normal variability in the face of acidemia led researchers to postulate that some aspect of variability control could be different in animals compared to humans.

In the human literature, four recent and independent studies using various definitions of acidosis and examining the last 30-60 minutes of the tracing reported that the percentage of babies with acidosis who had moderate variability ranged from 15% to 91%.20-23 Even with near lethal levels of uterine artery base deficit (>=16 mmol/L), a full 15 to 32% of these babies had moderate baseline variability in the tracing recorded just before birth.20, 21 Another study examined baseline variability in term babies who required supplemental oxygen for more than 6 hours or mechanical ventilation.24 In this study, marked variability in the last 30 minutes was significantly associated with these respiratory morbidities. Minimal variability was not. This finding is in keeping with other direct observations on the correlation between increased heart rate variability and catecholamines concentration on non-acidotic term fetuses.25 It appears that marked variability may be a sign of activation of compensatory pathways.

10 Mar

Best practices for High Reliability

best practices for high reliability in obstetricsUsing their extensive experience in implementing approaches to promote efficiency and high reliability in health care, the team of obstetric leaders who collaborated to author the recently released eBook A Vision of the Future of Obstetrics identified five key clinical best practices.  Here they are in summary:

Best practices for obstetric units

  1. Select a reasonable process
  2. Analyze and modify
  3. Target critical behaviors
  4. Clarify and define
  5. Choose wisely

The free eBook details clinical processes, developed by leading health systems, to execute these broad principles.

What practices is your hospital or health system using to improve efficiency and high reliability in labor & delivery?

Click to continue reading eBook in the Apple Store or as a PDF

03 Mar

A look behind to look ahead

Look into the future of obstetricsA look behind to look ahead for PeriGen

by Matthew Sappern
Chief Executive Officer, PeriGen

I know we are well in to 2016 already, but I want to take a moment to reflect on 2015 and the State of PeriGen.

This past year, PeriGen enjoyed explosive growth. Almost twice as many hospitals went live on PeriGen solutions than in any other year in our history! At the same time, we introduced a remarkable new module called the PeriCALM Checklist which helps makes checklist compliance easier; this tool won the 2015 FIERCE Healthcare Innovation Award.

In 2016, we will introduce a few more tools – tools designed to save nurses time as well as to leverage precious clinical resources across an entire healthcare system – more on these exciting innovations in a few months!

Now, we all know that explosive growth is a double-edged sword. PeriGen cannot allow this growth to come at a cost of service and responsiveness. To that end, we have added some new staff and tools to our implementation and support groups. Inside you will read about new FAQ tools and about Securelink, an application providing our team with secure, remote access – at a hospital’s request – to help troubleshoot issues. We are making support simpler, easier and more efficient. As I made clear to the entire PeriGen team on a recent “all-hands” call, we need to commit to providing an exceptional customer experience in 2016, nothing less.

Finally, as we all settle in to 2016, I invite you to spend some time with PeriGen’s SVP of Clinical Research Dr. Emily Hamilton, who has penned an article with some predictions about continued innovation in healthcare. Emily is one of the most forward-thinking professionals in healthcare today, I am sure you will enjoy her article and you will see PeriGen’s solutions continue to reflect her thinking.

As always, thank you for being a member of the PeriGen family and thank you for taking such great care of all the mothers and babies whose lives you touch.  Have a wonderful 2016!