Israeli Family Physicians: what to know?
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Israeli Family Physicians: what to know? Throwing the Mother Out with the Bathwater—Misuse of randomized controlled trials. Michael C. Klein Centre Community Child Health Research BC Research Institute for Children’s and Women’s Health Emeritus Professor of Family Practice and Pediatrics

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Michael c klein centre community child health research

Israeli Family Physicians: what to know?Throwing the Mother Out with the Bathwater—Misuse of randomized controlled trials

Michael C. Klein

Centre Community Child Health Research

BC Research Institute for Children’s and Women’s Health

Emeritus Professor of Family Practice and Pediatrics

University of British Columbia


Variation surfaces bc women s hospital 1993

Variation surfaces—BC Women’s Hospital 1993-----

25 docs 75% or more


Michael c klein centre community child health research

Family Physicians Nullip SVD Episiotomy RatesApr 95-Mar 96: mean rate=19.2Apr 96-Mar 97: mean rate=14.9April 98-Mar 99

2 remaining


Variation surfaces vancouver cqi 1993

Variation surfaces Vancouver CQI 1993


Does epidural analgesia increase the likelihood of cesarean section

Does Epidural Analgesia Increase the Likelihood of Cesarean Section?

  • How many think it does?

  • How many think it does not?


Epidural cxion

Epidural Cxion


A natural experiment at nearby community hospital

A natural experiment at nearby community hospital

  • In early 1990s Community Hospital had Cxion rate of about 8%, while Women’s about 20%

  • We Created matched cohort of healthy women

  • Odds of having a Cxion at the tertiary care centre vs community 3.4 (CI 2.1—5.4)

  • Why?

    • More advanced cervical dilation on arrival (opportunity for doulas)

    • Use of epidural analgesia—largest effect: Epidural rate of 15.4% community, 67.2% tertiary

      Janssen P, Klein MC. Differences in Institutional Cesarean Delivery Rates: The role of pain management. J Fam Pract 2001; 50(3):217-223


A natural experiment at nearby community hospital1

A natural experiment at nearby community hospital

  • Differences between the hospitals:

    • Increased ambulation at the community (12% vs 5%)

    • Fewer numbers of caregivers for each woman at community

    • More oxytocin augmentation at community

      (32.3 vs 24.9%)

    • Less offering of epidural at community (qualitative) 16.7% vs 42.3%

    • Strong Head of OB at community who worked collaboratively with strong nursing and FP leadership, and together developed a coherent philosophy of care


A natural experiment at nearby community hospital2

A natural experiment at nearby community hospital

  • But when controlled for epidural, the Cxion rate at the two hospital was the same, about 12%

  • In other words, women with an epidural in each facility had a similarly high Cxion rate and women not receiving an epidural had a similarly low Cxion rate

  • Only real difference was: community hospital used epidural less often, and in so doing had a low Cxion rate

  • When Head of OB retired and nursing leadership also changed, the epidural and Cxion rate at the community hospital rapidly reached usual levels for BC

    Janssen P, Klein MC. Differences in Institutional Cesarean Delivery Rates: The role of pain management. J Fam Pract 2001; 50(3):217-223


Meanwhile departmental cqi evolved into research

Meanwhile Departmental CQI evolved into research

  • We studied natural variation in relation to physician epidural rates

    • Maternal outcomes

    • Newborn outcomes

    • The physician rather than the woman as the unit of analysis


Michael c klein centre community child health research

Nulliparous Maternal Outcomes by Epidural Cohorts


Nulliparous malposition op ot rates by epidural by race

Nulliparous Malposition (OP-OT) Rates by Epidural by Race


Nulliparous oxytocin augmentation rate by epidural cohorts by race

Nulliparous Oxytocin Augmentation Rate by Epidural Cohorts by Race


Nulliparous cesarean rate by epidural cohorts by race

Nulliparous Cesarean Rate by Epidural Cohorts by Race


Epidural study

Epidural study


Michael c klein centre community child health research

Nulliparous NCN/SCN Admission Rates by Epidural by Race


Were the physicians who were in each epidural cohort practicing differently

Were the physicians who were in each epidural cohort practicing differently?

  • Not only did they use epidurals less often, but

    • Used epidurals later

    • Spent more time with their patients in hospital--even though their patients spent less time in hospital

    • Indeed they practiced differently—more intimacy and engagement


Michael c klein centre community child health research

  • Conclusion:

  • Physicians who employ epidural analgesia often (and early) in labor expose them to higher intervention rates and more adverse maternal and newborn outcomes than those who on average employ epidural analgesia less often and later in labor.


Michael c klein centre community child health research

But not the fault of the anesthesia establishment at BC Women’s or likely elsewhere.

Anesthesia provides an excellent service. They help us resolve many problems

It is we who ask for help!!!!!!!!!

At least at BC Women’s, there is no evidence that anesthetists are scavenging for business

There is evidence from rural family practice (Stuart Iglesias) that epidurals can be introduced and associated with lowering of Cxion rate

But that study requires contextual or environmental analysis


The tyranny of meta analysis

The Tyranny of Meta-analysis

And the misuse of Randomized Controlled Trials


Collateral damage or blowby think iraq

Collateral damage or Blowby—think Iraq

  • Or throwing the mother (and at times the baby) out with the bathwater.

  • Or consequences of left-sided thinking—what about the right side (think right brain)


David sackett understanding clinical trials bmj 309 1994

David Sackett: understanding clinical trials. BMJ 309: 1994

  • Information from trials “….should go far beyond efficacy…to include measures of harm as well as benefit and to integrate patient’s views on the quality of life with and without treatment, and to include economic consequences of the treatment alternatives.”


Cochrane meta analysis of effect of epidural analgesia

Cochrane Meta-analysis of Effect of Epidural Analgesia

  • Comparing Epidural to Narcotics

  • Previously meta-analyses showed a 10% increase in Cxion rate with epidural analgesia

  • Current Cochrane does not—why not? Is Cochrane wrong?

  • It is not the fault of the RCT as a methodology!!

  • It is the inclusion in the meta-analysis of studies that ought not to be there—or the studies need to be grouped or stratified according to their settings or approaches so one can know if the results apply to one’s own setting


Central concepts in applicability of ebm

Central Concepts in Applicability of EBM

  • Look at both the left and the right side of the equation

  • What about the “inadvertent” consequences of the approach or procedure addressed by the trial or what youare interested in compared to the big picture consequences for this and future pregnancies?


Michael c klein centre community child health research

4.3 hour increase with epidural

Sharma only 1 hour increase with epidural


Michael c klein centre community child health research

1.4 hour increase with epidural

Sharma only 19 min increase with epidural


Michael c klein centre community child health research

38%

52%

Sharma only 33% epidural 15% control


Michael c klein centre community child health research

15%

7%


Michael c klein centre community child health research

27%

16%

Increase in Perineal trauma as well

Sharma only 9.1% epidural versus 3.6% control


Michael c klein centre community child health research

24%

6%


Michael c klein centre community child health research

Why not an increase in cesarean as well?


Michael c klein centre community child health research

All studies: mixed parity, various concentrations of agents both study arms and mostly IM narcotic

12-13%

10-14%

5% both arms

Sharma: Dallas Parkland 12% base Cxion rate, low dose oxy augmentation, Randomization @4-5cms. Clark: Louisville, 70%>4 cms, high dose oxy, Loughan: London UK Randomization 3-4cms,

Sharma!!!!


Michael c klein centre community child health research

Klein Sensitivity Analysis: retaining only those studies that randomized early at < 4-5 cms


Michael c klein centre community child health research

  • Wong CA, Scavone BM, Peaceman AM, McCarthy RJ, Sullivan JT, Diaz NT, et al. The risk of cesarean delivery with neuraxial analgesia given early versus late in labor. N Engl J Med 2005;352: 655-65

  • Authors and NEJM editorialist claimed that early epidurals do not increase the rate of caesarean deliveries.

  • The study was not of early epidural analgesia, and the oxytocin augmentation rate of 75% at first analgesia makes for lack of generalisability.

  • The claim that women need not worry that early epidurals will lead to increased caesareans is false.


Michael c klein centre community child health research

  • This trial was about two methods of helping women with pain in early labour.

  • In the so called epidural arm, an epidural catheter was placed. On first request for analgesia, women received intrathecal fentanyl, and in the narcotic arm, hydromorphone.

  • On second request, almost two thirds of women in both arms were in active labour, 4 cm or more dilated.

  • In the intrathecal "epidural" arm, they received low dose epidurals; in the narcotic arm, hydromophone.


Michael c klein centre community child health research

  • This trial, as others that have contributed to the Cochrane meta-analysis showed no increase in caesareans in the presence of epidural analgesia, but does not acknowledge that most women were in active labour at time of second request or when they actually got an epidural-- when most will do well.

  • Wong et al, like Sharma et al, the other major contributors to the Cochrane meta-analysis showing no difference, have shown only that when women's pain in the latent phase is managed with intrathecal, narcotic, or other pharmacological or non-pharmacological means, an epidural in the active phase of labour does not increase the rate of caesarean section.

  • And neuraxial analgesia. Mmmmmmmmmmmmmm


Ohel from israel am j obs and gyn 2006 vol 194

Ohel from Israel (Am J Obs and Gyn 2006 vol 194)

  • Well conducted RCT of Epidural vs Narcotics

  • 449 nulliparous women at term randomized at less than 3 cms

  • Mean point of randomization 2.6 vs 4.6 cms for epidural vs narcotic

  • CS 13% vs 11% (LOW!!!!!!!!!!!!!)

  • But labor supported by nurse midwives fully—Obstetricians only as consultants

  • Clearly an intimate style of care

  • Again it is about environment—yours?


Latest meta analyses

Latest Meta-analyses

  • Patient-requested Neuraxial Analgesia for Labor--Marucci et al Anesthesiology May 2007

    • Review comes up with the same conclusions based on the same literature

  • New Cochrane meta-analysis same

  • All now state that early epidurals are not a problem


Michael c klein centre community child health research

Epidural analgesia, while a superb technology, and the “best” form of pain relief has completely transformed normal birth--leading to a cascade of interventions.

  • 3 of 4 Canadian women receive one or more major procedures or interventions in labor (CIHI, 2004) and epidurals are a major contributing cause: Epidural Rate 45.4% Canada, 36.3% Vancouver and rising


Why don t we acknowledge that epidural analgesia has changed the landscape

Why don’t we acknowledge that Epidural Analgesia has changed the landscape?

  • Subversion by RCTs and EBM?

  • Cochrane reviews by

    • Anesthesiologists?

  • Nurse/Doctor’s comfort—we like it!!

  • Economics?

  • Existence of a dedicated anesthetic workforce that we created?

  • Not the fault of the anesthesia establishment!!!!! We asked for it

  • Women asked for it

    • (Think Twilight Sleep)

    • but we taught them to ask for it!


Michael c klein centre community child health research

From EBM to Research designed to deliver answers that we want to receive!From Evidence-based decision-makingTo what Philip Hall has called:

  • “Decision Based EvidenceMaking”


Whose evidence

Whose evidence?

  • Does the study setting apply to me in my setting?

  • Basic problems with RCTs

    • Results apply only for the conditions of the trial (“Murray Enkin’s first law”)

  • Are conditions my conditions?

    • Do the participating practitioners practice the way that I practice?


Michael c klein centre community child health research

  • Collateral damage or Blowby (2)

    • Example: Canadian Post-Term trial of expectant management vs induction at 41 weeks

      • Outside rarified atmosphere of the RCT, thinking that placenta degenerates at 41 3/7th weeks unleashes a cascade of “side effects” NO! EFFECTS--resulting in increased not decreased cxion rates and consequences for next pregnancy: 8% vs 44% cxion rate for nulliparous women at BC Womens


Michael c klein centre community child health research

  • Post-term trial: this and subsequent pregnancies, increase in:

    • induction, EFM, epidurals, instrumentation, perineal trauma, Cxions, sense of failure, parenting problems, postpartum DIC

    • Next pregnancy: placental previa and other problems of placentation, abruptions, ectopics, infertility, stillbirths


The induction cascade

The Induction Cascade

  • Induction requires continuous electronic fetal monitoring because it is considered a “high risk” procedure.

    • This is because over-stimulation of the uterus can occur and that can lead to stress on the fetus.

      • Women receiving continuous electronic fetal monitoring are kept in bed almost all the time.

        • Immobility leads to abnormal progress of labor, which in turn leads to labour dysfunction


Induction cascade 2

Induction Cascade 2

  • Continuous electronic fetal monitoring leads to more cesarean sections, likely because of the immobility and because abnormalities that are seen on the monitoring tracings are often misinterpreted as “fetal distress,” and cesarean is the usual response.

    --Labors that are induced are more painful than labors that occur naturally.

    --Hence women are much more likely to receive an epidural analgesic than women in spontaneous labor.


Induction cascade 3

Induction Cascade 3

  • Epidural analgesia gives very effective pain relief—but “there is no free lunch!”

    --Epidural analgesia causesposterior pituitary gland to produce less natural oxytocin

    --Epidural analgesia will greatly prolong the first stage of labor on average by 3-4 hours


Induction cascade 4

Induction Cascade 4

  • If given very early in labor at less than 4 centimeters of cervical dilation (which is the case in most labors), epidural analgesia causes abnormal positions of the fetus, such as an extended neck rather than the usual flexed position. This leads to more back labors (posterior labors) and transverse or side positions.

    • A baby whose head is extended cannot rotate and cannot easily descend in the birth canal.

      • Epidural analgesia will increased the length of the second stage of labor by at least 30 minutes


Induction cascade 5

Induction Cascade 5

  • Epidural analgesia will lead to the inability of women to push effectively, thus leading to more use of synthetic oxytocin and need for assistance in the delivery by use of vacuum or forceps.

    --The use of these instruments in the presence of epidural analgesia, and even without, will lead to more perineal traurequiring stitching.

    --If given early in labor, epidural analgesia will increase the cesarean section rate by more than two times over women not receiving epidurals at all or only after 4-5 centimeters of cervical dilation.


Induction cascade 6 the psychological cascade

Induction Cascade 6 (the Psychological cascade)

  • Induction changes everything

    • The birth process has now been moved from her process to process managed and controlled by the caregivers and the system

      • What takes place is largely driven by protocols and guidelines. This is true birthcontrol


Induction cascade 7 the psychological cascade

Induction Cascade 7 (the Psychological cascade)

  • She now needs management and her fetus is potentially at risk for the consequences of the interventions that follow logically from the induction.

    • We watch her more carefully, and we will indeed find things to worry about. It just goes with the territory.

      (Some of those findings will be real and would have occurred anyhow due conditions present in the mother or the fetus, but others will be caused by the interventions dictated by her altered state--caused by our good intentions. [In medicine we have a term for this: iatrogenic disease or disease cased by doctors (or any caregiver behaving this way)].

      • Friendly fire or collateral damage can be the result

        • And it is not just that we professionals will feel differently about the induced woman, but she will feel differently about herself.


Induction cascade 8 the psychological cascade

Induction Cascade 8 (the Psychological cascade)

  • She will have begun to feel less in control, less confident, less competent, more dependent

    • Dependency feeds into the laboring process itself.

      • Increased maternal anxiety is inevitable and leads to the production of stress hormones that interfere with ands slow labor --And this feeds back into the evolving cascade such that a sense of the joy and power and the transformative nature of childbirth are undermined.


Induction cascade 9 the next birth cascade

Induction Cascade 9 (The Next Birth Cascade)

  • Now she has a uterine scar

    • When the fertilized egg searches for a place to attach, it can attach low down at or on the scar.

      (Scar made up of a fiber-like material rather than the soft , juicy material of normal lining of uterus).

      --Then the attachment of what will become the developing placenta will be weak and subject to pealing off as the placenta and

      uterus grow


Induction cascade 10 the next birth cascade

Induction Cascade 10 (The Next Birth Cascade)

Placental abruption occurs, when the placenta detaches itself in whole or in part, leading to severe bleeding and high likelihood of loss of the pregnancy. [Note that in Canada ectopic pregnancy rates increased from 10/1000 to 16/1000 between 1981 and 1990, parallel to the rise in the cesarean section rates].

  • If the fertilization occurs in the fallopian tube, the result is ectopic pregnancy--also leads to bleeding and fetal loss.

  • If the attachment is placed over the inner opening of the cervix, the result is a “placenta previa,” which can be an emergency leading to cesarean section and a fetus at risk.

  • If the attachment “invades” the wall of the uterus it is placenta accreta. This is a placenta that will not detach at the birth, with very severe bleeding consequences and likely loss of the uterus for future childbearing.


Induction cascade 11 the next birth cascade

Induction Cascade 11 (The Next Birth Cascade)

  • Adhesions secondary to the first cesarean surgery can lead later to maternal bowel obstruction.

  • All these complications are increased once a woman has had the first cesarean, and if present, make the woman more likely to have problems getting pregnant the second time (infertility) and if she gets pregnant, of having a stillbirth.

  • Paradox: We started the induction to prevent stillbirth…………………………


Michael c klein centre community child health research

  • Post-Term trial about induction

    • Results in huge number of women thinking that they are biologically defective—biological nonsense

    • 1000 inductions needed to possibly prevent one stillbirth BUT at what price? This is the right side of the equation. Informed consent?

    • Contributes massively to medicalization of childbirth that has led some to suggest that Cxion-on-demand is an answer—a surgical fix for a problem in caring.


Michael c klein centre community child health research

  • COMMENTARY ON: Lyerly et al: Values, and decision making surrounding pregnancy. Obstet Gynecol 2007;109(4):979–98 in The Patient-Centered (R)Evolution

“The risk discussion about induction for post-term pregnancy care focuses on the perceived risk of NOT inducing rather than the risk of operative delivery associated with induction. Furthermore, the risk discussion about NOT allowing spontaneous labor and primary vaginal delivery misses a full discussion of the risk of elective primary cesarean. In intrapartum care, our risk distortion is that we err on the side of intervening too much.”--Andrew Kotaska


Other problematic rcts

Other Problematic RCTs

  • Walking in Labor—NEJM

    (1998:Bloom et al Volume 339:76-9)

  • Term-Breech Trial


Misuse term breech trial results

Misuse Term-Breech TrialResults

  • Trial showed at 3 months postpartum that newborn and mother better off with CS for prevention of pelvic floor problems

    (UI, Fecal Incontinence, Sexual)—generalized to vertex births.

  • OBs stopped delivering breeches even before trial published—why?

  • But 2 year f/u shows no difference in any maternal or newborn outcomes—including pelvic floor

  • And pelvic floor outcomes—what does it say about the resilience and self-healing properties of pelvic floor for women experiencing vaginal birth?


Michael c klein centre community child health research

GBS!!!!!!!!!!!

  • And think ahead to the collateral damage caused by our obsession with GBS—at what price to the mother for a marginal to no advantage to the baby?

  • BC Women’s status pre and post case finding and now screening?

  • More antibiotics for the mother: anaphylaxis, changes in bacterial flora, emergence of resistant strains

  • Further disruption of what would have been normal labor- -IV, early admission to hospital, induction/augmentation if NIL and the cascade of interventions including CS


Michael c klein centre community child health research

GBS!!!!!!!!!!!

  • Left sided thinking!

  • Pediatricians and infectious disease specialists worry about the baby

  • Fair enough, but what about the mother?

  • Right side is collateral damage to the mother


Michael c klein centre community child health research

The precautionary principle of non-maleficence (first do no harm), requires that potentially harmful actions or routines in the “management” of vaginal birth be eliminated before recommending a potentially harmful intrusion like routine epidural analgesia or Cesarean on demand.


Michael c klein centre community child health research

Examples of such practices:

  • undermining women’s capacity to give birth with as little intervention as possible

  • failure to utilize non-pharmacological approaches to pain management first

  • unsupported labor (think doulas)

  • unphysiological positions and purple pushing

  • routine episiotomy

    All of which lead to complications that make women feel incapable of giving birth without massive intervention and promote requests for early epidurals and even Cxion on demand


The end

The End


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