Re: 'There is no gold standard for decision-to-incision time' ???
From: art fougner, md (evsono@pipeline.com)
Sun Oct 7 08:04:34 2007
In view of the rising C-section rate, OB units need to further evaluate
the scenario arising when two sections are simultaneously indicated?
Second room? Call in second team? Which takes precedence? etc.
Art
At Sat, 6 Oct 2007, Efrain Ramirez wrote:
>
>Question is - why ACOG set those standards?
>
>Ef
>
>>At Sat, 6 Oct 2007, Larry Glazerman wrote:
>>
>>On a related note, there is NO published standard, guideline, etc.,
>>requiring a 30 minute decision to incision time. This came from the
>>Guidelines for Perinatal Care, which says that in order to have an ob
>>unit, a hospital must be ABLE to perform a c-section in 30 minutes
>>(incision to decision) WHERE INDICATED. The examples given, if I
>>recall, are things like cord prolapse, severe hemorrhage. Further, as
>>in the article cited, there's no data to support better outcomes when
>>the C-section is done in 30 minutes. Plaintiffs' lawyers have
>>bastardized this for their own benefit.
>>Larry R. Glazerman, MD, FACOG
>>St. Luke's Center for Advanced Gynecologic Care
>>250 Cetronia Road
>>Suite 305
>>Allentown PA 18104
>>484-223-3279
>>484-223-2830 FAX
>>glazerl@slhn.org
>>
>>On Oct 6, 2007, at 4:16 PM, Efrain Ramirez wrote:
>>
>>> There is no gold standard for decision-to-incision time
>>> Don’t accommodate plaintiff’s attorneys who have reinvented an
>>> intended
>>> guideline as a requirement!
>>>
>>> Fast Track
>>>
>>> Just over 95% of babies delivered in more than 31 minutes had none of
>>> the six adverse outcomes studied
>>>
>>> Don’t settle a case in which you’ve been accused of a bad outcome just
>>> because a C-section wasn’t begun in less than 30 minutes
>>>
>>> IN THIS ARTICLE
>>>
>>> Are outcomes different on the two sides of the 30-minute threshold?
>>>
>>> How to respond to a charge of “taking too long”
>>>
>>> Arnold W. Cohen, MD
>>> Chair, Department of Obstetrics and Gynecology, Albert Einstein
>>> Medical
>>> Center, and Professor of Obstetrics and Gynecology, Jefferson Medical
>>> College, Philadelphia, Pa.
>>>
>>> David M. Jaspan
>>> Chief of Gynecologic Surgery, Albert Einstein Medical Center,
>>> Philadelphia, Pa.
>>>
>>> The authors report no financial relationships relevant to this
>>> article.
>>>
>>> CASE: Primigravida with ruptured membranesA 21-year-old patient was
>>> admitted to the labor and delivery suite in active labor. After a
>>> reassuring fetal tracing was documented, active management with
>>> oxytocin
>>> was initiated.
>>>
>>> Five hours later, the nurse noted a prolonged deceleration.
>>>
>>> Resuscitative efforts failed to alleviate the deceleration. The nurse
>>> notified the attending OB of the situation. An emergency cesarean
>>> section was called because:
>>>
>>> of a nonreassuring fetal heart rate tracing and
>>>
>>> delivery was not imminent.
>>>
>>> Now, the attending leaves her home promptly to perform the cesarean
>>> section; the anesthesiologist, who is not in the hospital, is
>>> notified.
>>>
>>> The team is assembled and the patient is moved to the operating
>>> room; 34
>>> minutes have elapsed between the time the decision was made to perform
>>> the cesarean section and the time the incision is made on the abdomen.
>>>
>>> Two minutes later, the baby is delivered. Apgar scores are as
>>> follows:
>>> 0 at 1 minute; 0 at 5 minutes; 0 at 10 minutes; and 1 at 15 minutes.
>>>
>>> Subsequently, the baby is determined to be severely brain-damaged.
>>> The
>>> parents file a claim of malpractice.
>>>
>>> ObGyns have come to depend on ACOG’s Committee Opinions, Educational
>>> Bulletins, Practice Bulletins, Policy Statements, and Technology
>>> Assessments to help us take the best care of our patients. To
>>> quote the
>>> College, each of these documents “is reviewed periodically and either
>>> reaffirmed, replaced, or withdrawn to ensure its continued
>>> appropriateness to practice.”1
>>>
>>> Sometimes, however, an ACOG bulletin, statement, or assessment may be
>>> misinterpreted and can actually contribute to some of the medicolegal
>>> problems that we face. The actual clinical situation just described,
>>> relating to ACOG’s statement on the so-called decision-to-incision
>>> gold
>>> standard, is a case in point.
>>>
>>> The parties in the case go to trial
>>> During the subsequent trial, the plaintiff alleges negligence by
>>> claiming that the defendant:
>>>
>>> did not anticipate or recognize developing fetal problems
>>>
>>> failed to perform a C-section within 30 minutes after the decision was
>>> made to do so.
>>>
>>> The defendant counters:
>>>
>>> There was no fetal indication of hypoxia or cause for concern until
>>> the
>>> fetal bradycardia was noted
>>>
>>> Brain damage was caused by an unanticipated event that occurred more
>>> than 30 minutes before delivery
>>>
>>> The team responded as rapidly as it could given the circumstances
>>> of the
>>> hospital and staffing patterns.
>>>
>>> No verdict was reached; instead, the parties agreed to a
>>> multimillion-dollar settlement that is based on 1) more than 30
>>> minutes
>>> having elapsed from “decision to incision” and 2) the assertion that a
>>> 30-minute decision-to-incision time is the standard of care for an
>>> emergency C-section.
>>>
>>> TABLE
>>> Outcomes are no better when the decision-toincision time is less
>>> than 30
>>> minutes3
>>> OUTCOME INCIDENCE AT <30 MIN INCIDENCE AT >30 MIN
>>> Urine pH, <7.0 4.8% 1.6%*
>>> Intubation in delivery 3.1% 1.3%*
>>> Hypoxic–ischemic encephalopathy 0.7% 0.5%
>>> Fetal death 0.2% 0%
>>> Neonatal death 0.4% 0.2%
>>> Apgar score at 5 min, <3 1.0% 0.9%
>>> None of the above 92.6% 95.4%*
>>> *P <.05
>>>
>>> Are we held to a standard that can’t be met and has no basis in
>>> evidence?
>>> To repeat, as reported in hospital records admitted into evidence at
>>> trial, the baby was delivered, with a low Apgar score, 34 minutes
>>> after
>>> the decision was called. The fact that the incision commenced after
>>> more than 30 minutes was a major factor contributing to the
>>> multimillion-dollar settlement.
>>>
>>> That 30-minute mark is taken directly from the fifth edition of ACOG’s
>>> Guideline for Perinatal Care:
>>>
>>> Any hospital providing obstetric service should have the capability of
>>> responding to an obstetric emergency. No data correlate the timing of
>>> intervention with outcome, and there is little likelihood that any
>>> will
>>> be obtained. However, in general, the consensus has been that
>>> hospitals
>>> should have the capability of beginning a cesarean section within 30
>>> minutes of the decision to operate.2
>>>
>>> The interpretation that all C-sections must be performed within 30
>>> minutes of a decision is challenged by a recent study sponsored by The
>>> National Institute of Child Health and Human Development (NICHD)
>>> Maternal–Fetal Medicine Units Network.3 The design of that study was
>>> observational, because no ethical means exist to randomize women to
>>> less
>>> than or more than 30 minutes from the time of a decision to perform a
>>> C-section to the time of the incision.
>>>
>>> The data collected came only from primagravid women in active labor
>>> who
>>> had an infant that had a birth weight of more than 2,500 g.
>>> Indications
>>> for C-section included: nonreassuring fetal heart rate, umbilical cord
>>> prolapse, placental abruption, placenta previa with hemorrhage, and
>>> uterine rupture. A total of 11,481 cases were analyzed over a 2-year
>>> period, with 2,808 C-sections performed for those indications (a 24.5%
>>> rate of C-section). Ninety-four per cent of the C-sections were
>>> undertaken because of a nonreassuring fetal heart rate.
>>>
>>> In a university setting, where one would expect in-house OB
>>> coverage and
>>> anesthesia to be available, only 65% of emergency C-sections commenced
>>> within 30 minutes of a decision (17% in less than 10 minutes; 27% in
>>> less than 20 minutes). Investigators also found that, in cases in
>>> which
>>> a C-section was performed for a nonreassuring fetal heart rate,
>>> only 62%
>>> were performed in fewer than 30 minutes.
>>>
>>> The data are clear: More than one third of all C-sections for these
>>> indications did not comply with the “30-minute rule.”
>>>
>>> Notably, the study also found that:
>>>
>>> when the decision-to-incision time was less than 30 minutes, the rates
>>> of fetal acidemia and intubation in the delivery room were higher
>>>
>>> 95% of infants delivered in more than 31 minutes did not experience
>>> any
>>> of the adverse outcomes listed in the accompanying TABLE
>>>
>>> only one of eight neonatal deaths occurred in the group of infants
>>> delivered after 31 minutes (at 33 minutes).
>>>
>>> The investigators also found that decision-to-incision time had no
>>> impact on maternal complications.
>>>
>>> 30 minutes? It’s not a mandate
>>> The study supported by NICHD shows that:
>>>
>>> the decision-to-incision interval appears to have no impact on
>>> maternal
>>> complications
>>>
>>> an infant delivered within 30 minutes for an emergency indication was
>>> more likely to be acidemic and to require intubation than an infant
>>> delivered in longer than 30 minutes for an emergency indication
>>>
>>> delivery within 30 minutes does not guarantee that there will be no
>>> adverse outcome
>>>
>>> 95% of infants delivered in more than 30 minutes did not have
>>> compromise.
>>>
>>> Where did it originate? These facts make us wonder: How did the
>>> controversial, seemingly random time of 30 minutes crawl into the
>>> courtroom and become a benchmark? Why have attorneys and expert
>>> witnesses for the plaintiff taken this 30-minute rule to be fact?
>>>
>>> The ACOG guideline is, as stated, clearly not a requirement. It does
>>> not mandate that all C-sections commence within 30 minutes from the
>>> time
>>> of the decision to perform one. Rather, the guideline clearly states
>>> that the hospital should be capable of performing the procedure within
>>> 30 minutes.
>>>
>>> To be clear, we are not advocating a guideline or policy of waiting to
>>> perform a C-section! We believe rapid delivery is proper. But the
>>> optimal time, or even minimal time, to delivery has not been
>>> defined by
>>> data—and may never be.
>>>
>>> What should it really mean? Thirty minutes, therefore, should be a
>>> goal,
>>> not a finite time. Data published by NICHD should now be used to
>>> temper
>>> notions that exceeding the so-called 30-minute rule necessarily 1)
>>> is an
>>> indicator of sub-standard care and 2) has adverse effects on
>>> outcome for
>>> the newborn.
>>>
>>> Perhaps it’s time for ACOG to review these recent data and then
>>> reaffirm, replace, or withdraw the statement from the perinatal
>>> guidelines proposing that 30 minutes be the maximum time from decision
>>> to incision.1
>>>
>>> Here’s what you should do until the matter is clarifiedIf you must
>>> defend yourself against an accusation of not having performed a
>>> C-section in a timely fashion, data from the NICHD Perinatal
>>> Collaborative may offer a helpful defense. Because 38% of C-sections
>>> for a nonreassuring fetal heart rate tracing are not performed
>>> within 30
>>> minutes of a decision to proceed, even in a university setting, this
>>> cannot be considered a standard and not meeting this arbitrary time
>>> should be looked on as a frequent occurrence.
>>>
>>> Based on current data, therefore, any medicolegal case in which the
>>> plaintiff’s attorney implies that failure to conform to this putative
>>> standard resulted in a bad outcome should be defended vigorously—and
>>> should not be settled.
>>>
>>> References
>>> 1. 2006 Compendium of Selected Publications. Washington, DC:
>>> American
>>> College of Obstetricians and Gynecologists, Women’s Health Care
>>> Physicians; 2006:v.
>>>
>>> 2. Guidelines for Perinatal Care, 5th ed. Washington, DC: American
>>> College of Obstetricians and Gynecologists; 2002:147.
>>>
>>> 3. Bloom SL, Leveno KJ, Spong CY, et al. National Institute of Child
>>> Health and Human Development Maternal–Fetal Medicine Units Network.
>>> Decision-to-incision times and maternal and infant outcomes. Obstet
>>> Gynecol. 2006;108:6–11.
>>>
>>> OBG Management ©2007 Dowden Health Media
>>>
>>> --
>>> "I can accept failure, but I can't accept not trying." - Michael
>>> Jordan
>
>--
>“ The greatest obstacle to knowledge is not ignorance,
>it is the illusion of knowledge.” Daniel J. Boorstin - Historian
>
--
art fougner, md
"May The Wings of Liberty Never Lose a Feather." - Jack Burton
