Re: 'There is no gold standard for decision-to-incision time' ???
From: Efrain Ramirez (eramirezt@coqui.net)
Sat Oct 6 20:11:58 2007
Agree --
Ef
>At Sat, 6 Oct 2007, R. Daniel Braun wrote:
>
>Question relating to the case presented. How long from last listening for
>FHT's and incision? It is easy to stand around in the OR waiting for that
>last member of the team to arrive and then just make the incision when they
>get there. One should always know whether or not there is a heart beat
>before making the incision. IMHO.
>With a one and 5 minute apgar of "0", I find it hard to believe that there
>were ht. tones present in the last 3-5 minutes befor the incision.
>
>Dan
>On 10/6/07, Efrain Ramirez <eramirezt@coqui.net> 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 (c)2007 Dowden Health Media
>>
>> --
>> "I can accept failure, but I can't accept not trying." - Michael Jordan
>>
>--
>R. Daniel Braun, MD FACOG(L) CMT
>Professor Emeritus
>Dept. of Obstetrics and Gynecology
>Indiana U. School of Medicine
>
>--
>R. Daniel Braun
>
>"
> Einstein 1941
>
--
“ The greatest obstacle to knowledge is not ignorance,
it is the illusion of knowledge.” Daniel J. Boorstin - Historian
