The Use of Data for Decision Making: ACOG’s Committee Opinion #476

Planned Home Birth

William H. Barth, Jr., M.D.

11 July 13

Disclosures

• I am an obstetrician whose salary is supported by attending hospital deliveries

• ACOG Fellow

• Past Chair of the ACOG Committee on Obstetric Practice and primary author for the “Planned Home Birth” Committee Opinion

• I am the Medical Director for a hospital based midwifery practice in Boston (Supervisor)

Objectives• Describe the genesis of ACOG’s

Committee Opinion on Planned Home Birth

• Describe limitations of existing data sets

• Describe features of the ideal data set from a decision making perspective

• 2003 US Standard Certificate of Live Birth: possible birth setting specific modifications

Outcome of planned home births in Washington State: 1989 to 1996

Pang JYW, et al. Obstet Gynecol 2002;100:253-9

Study design: Retrospective cohort studyData source: Birth certificatesCountry/State/Province: Washington State

Outcome of planned home births compared to hospital births in Sweden between 1992 and 2004. A population-based register study

Outcome Planned HomeN = 897

Planned HospitalN = 11,341

RR (95% CI)

Neonatal Death 2.2/1000 0.7/1000 3.6 (0.2 – 14.7)

Cesarean section 22 (2%) 776 (7%) 0.4 (0.2 – 0.7)

Operative vaginal 20 (2%) 1089 (10%) 0.3 (0.2 – 0.5)

Sphincter rupture 3 (0.3%) 311 (2.7%) 0.2 (0.2 – 0.7)

Lindgren HE, et al. Acta Obstet Gynecol Scand 2008;87:751

Study design: Retrospective cohort studyData source: Swedish Medical Birth Register +Country/State/Province: Sweden

de Jonge A, et al. BJOG 2009;116:1177-84

Study design: Retrospective cohort studyData source: National perinatal database (3 linked files) Country/State/Province: Netherlands

Perinatal mortality and morbidity in a nationwide cohort of 529,688 low-risk planned home and hospital births

Outcomes of planned home birth with registered midwife versus planned hospital birth with midwife or physician

Janssen PA, et al. CMAJ 2009;181:6-7.

Study design: Population-based cohort studyData source: provincial Perinatal database registryProvince: British Columbia

Outcomes of planned home birth with registered midwife versus planned hospital birth with midwife or physician

Study design: Population based cohort studyData source: provincial Perinatal database registryProvince: British Columbia

Janssen PA, et al. CMAJ 2009;181:6-7.

Outcomes associated with planned home and planned hospital births in low-risk women attended by midwives in Ontario,

Canada, 2003-2006: A retrospective cohort study

Hutton EK, et al. Birth 2009;36:180-9

Study design: Retrospective cohort studyData source: Ministry of Health database of Midwifery CareCountry/State/Province: Ontario, Canada

ACOG Process for Committee Opinion

• Subject proposed to committee (many prompts)• Primary author assigned• Professional literature search provided• Draft provided prior to Committee• Discussed by Committee (ACOG Fellows, AAP, AAFP,

ACNM, NICHD, CDC, SMFM, ACOG Staff)• Revised draft reviewed 6 months later• Sent to Clinical Document Review Panel• Sent to ACOG Executive Committee• Published in Obstetrics and Gynecology and online• ACOG Press Release• Reviewed for content, relevance and need 18-24 months

Maternal and newborn outcomes in planned home birth vs.. planned hospital births: a meta-analysis

Wax JR, Lucas FL, Lamont M, et al. Maternal and newborn outcomes in planned home birth vs.. planned hospital births: a metaanalysis. Am J Obstet Gynecol 2010;203:243.e1-8.

Maternal and newborn outcomes in planned home birth vs. planned hospital births: a meta-analysis

Wax JR, Lucas FL, Lamont M, et al. Maternal and newborn outcomes in planned home birth vs. planned hospital births: a metaanalysis. Am J Obstet Gynecol 2010;203:243.e1-8.

In the wake of a meta-analysis

“In response to the concerns that were expressedin the letters, the American Journal of Obstetrics andGynecology convened an independent review panel to (1) review the article that was published and these letters to the editors and (2) make recommendations to the Journal. The review panel consisted of 3 panelists who are all specialists in maternal fetal medicine, with expertise in metaanalysis and clinical research.”

“In all 3 cases, the results the panel found were slightly different from the result in the manuscript,although there was no difference in (1) the direction of the point estimate of the pooled odds ratio or (2) the overall “statistical significance” of the result. The panel made the following recommendations: (1) The Journal should publish online full summary graphs for each outcome that was assessed in the study, which will allow readers to assess the study findings better, and (2) no retraction of the article is necessary.”

Reaffirmed 2013

GPC 6th Ed 2007 GPC 7th Ed 2012

Personal Observations• Review process is far more rigorous than

standard journal “peer review”• Written from a US perspective

– Great regional variation in healthcare infrastructure and access

– Cautious use of data from outside the US

• Carefully worded to minimize ambiguity and avoid overstatement

• In the end, it remains an opinion

What Data is Available to Inform Outcomes for Birth Setting

• Birth certificates– 2003 US Standard Certificate of Live Birth– State based reporting

• Registries– Birth center study (AABC)– MANA Stats (NARM)

• Data sets compiled for individual reports• Payers

Features of an ideal data set…

• Ascertainment: “intended place of delivery”

• Selection criteria: “appropriateness” (ante, intrapartum)

• Type of attendant: education, certification and licensure

• Integration of health system; transport agreements, geography, indication for transport

• Ascertainment: outcomes

– Standardized definitions (reVITALize, NCHS, etc.)

• Health system IT, EMR, common review

• Mandatory, audited, enforced reporting

• Publically available for download and analysis

Birth Certificates• ACOG and others have pushed for adoption of the US

Standard Certificate of Live Birth– (36 States, DC, Puerto Rico, Northern Marianas)– (32 States use US Standard Report of Fetal Death)

• Model legislation written in 2009• Every issue of Guidelines for Perinatal Care• Every opportunity for public comment• Cause for optimism: NAPHSIS and NCHS agreement,

possibly by 1 Jan 2014

2003 US Standard Certificate of Live Birth

Does not capture planned home birth transferred to hospital.

Does not distinguish CPM, LM, DEM, or other

Non-specific, does not necessarily capture transfer from home.

None capture reason for transfer.

2003 US Standard Report of Fetal Death

Does not capture planned home birth transferred to hospital.

Does not distinguish CPM, LM, DEM, or other

Does not capture location of intrapartum fetal death if known

7.

14.

Use of Data for Decision Making

• Depends on who is making the decision: each will have different perspective and values– Patients– Providers– Payers– Government agencies

• We have not discussed ethics of decision making regarding birth setting

Conclusions: Data for Decision Making

• No RCTs of sufficient size to inform birth setting• Only imperfect case series and cohort studies

– Ascertainment of intended birth setting– Provider education, training, certification and licensure– Nonstandard selection criteria– Non-uniform definitions of outcomes – follow up– Great regional variation in health system infrastructure

• No uniform data platform to adequately compare birth settings in the US

Recommendations• Continue to encourage the states to adopt the 2003 US Standard

Certificates of Live Birth, Death and Fetal Death

• We need minor modifications to 2003 US Standard Certificate of Live Birth and Report of Fetal Death to help inform the issue of birth setting, other issues– Intended birth setting

– Attendant

– Other: risk stratification, care processes, more…

Supplemental Slides

Grimes and Schulz. Limitations of Epidemiology. Obstet Gynecol 2012.

Neonatal Death: All

Neonatal Death: Non-anomalous

MANA Stats

Enrollment is voluntaryParticipation rates: CPM (20-30%), CNM/CM (17%)Individual patients must consent to participate (<3% decline)May withdraw from reporting (approx 8% incomplete)All birth settings: home, birth center, hospitalMidwives: CPM > CNM/CM > other midwivesData collection process 2.0, 3.0 and newer 4.0Efforts underway to encourage/mandate reportingData quality assurance: automated review, “Data Doula”

Outcomes of planned home births with certified professional midwives: large prospective study in North America

Johnson KC, Daviss B-A. BMJ 2005;330:1416–9

5418 Women planning home delivery with CPM in 2000

Transferred to hospital 12.1%Epidural 4.5%Episiotomy 2.1%Forceps 1.0%Vacuum 0.9%Cesarean delivery 3.7%

Total non-anomalous death 2.0/1000Total low risk non-anomalous 1.7/1000

J Midwifery Women's Health 2013 (Jan/Feb);58:3–14

American Association of Birth Centers (AABC)AABC Standards for Birth CentersCommission for the Accreditation of Birth Centers (CABC)AABC Uniform Data Set (UDS)41% of Birth Centers known to AABC are members78% of AABC members participate in the online registry79 Birth Centers in 33 states

Cesarean section 6%, maternal mortality 0, intrapartum death 0.47/1000, neonatal mortality 0.4/1000

Other Sources (not all inclusive)

• National perinatal data collection efforts– University Health Consortium (UHC)– National Perinatal Information Center (NPIC)

• States’ perinatal reporting beyond birth certificates: CMQCC, OPQC, others

• Payer or system data sets: HCA, Kaiser, Intermountain Healthcare, DoD, others

• Professional org: Women’s Health Registry Alliance

Perinatal and maternal outcomes by planned place ofbirth for healthy women with low risk pregnancies: theBirthplace in England national prospective cohort study

BMJ 2011;343:d7400 doi: 10.1136/bmj.d7400 (Published 24 November 2011)