Re: 'There is no gold standard for decision-to-incision time' ???
From: Larry Glazerman (l.glazerman@rcn.com)
Sat Oct 6 20:20:49 2007
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
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