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Evidence Limited to Inform Decisions about Maternal-Fetal Surgery

Evidence Limited to Inform Decisions about Maternal-Fetal Surgery . Katherine E. Hartmann, MD, PhD Lucius E. Burch Chair, Obstetrics and Gynecology Deputy Director, Institute for Medicine and Public Health Director, Vanderbilt Evidence-based Practice Center. Technical Brief Intent.

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Evidence Limited to Inform Decisions about Maternal-Fetal Surgery

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  1. Evidence Limited toInform Decisions about Maternal-Fetal Surgery Katherine E. Hartmann, MD, PhD Lucius E. Burch Chair, Obstetrics and Gynecology Deputy Director, Institute for Medicine and Public Health Director, Vanderbilt Evidence-based Practice Center

  2. Technical Brief Intent Summarizing the state of the field including: • Content of the research • Access to fetal surgery • Training of providers • Ethical aspects • Coverage of procedures • Ongoing studies

  3. Selection of target conditions • Cardiac malformations • Congenital diaphragmatic hernia • Myelomeningocele • Obstructive uropathy • Sacrococcygeal teratoma • Thoracic lesions (Congenital Pulmonary Airway Malformations) • Twin-twin transfusion syndrome

  4. Review Team & Expert Panel Selection • Fetal sonographers/echocardiographers • Maternal-fetal medicine specialists • Perinatal geneticists • Pediatric surgeons • “Fetal” surgeons • Neonatologists • Biomedical ethicists • Generalists prenatal care providers • Familiarity with perinatal hospice

  5. State of the Evidence Methods • PubMed, MEDLINE (no date limits) • English, ≥ 2 cases, condition of interest, fetal intervention, training information, outcomes including quality of life (for mother or fetus) • Included RCT, cohorts with comparison, case-control, and case series

  6. State of the Evidence Review Methods • Dual review of abstracts • Dual review of articles • Extraction of descriptive data into standardized forms: • study design and setting • fetal and maternal inclusion criteria • training of providers • outcomes measured • length of follow up

  7. Disposition of the Literature • Abstracts: 1382 • Articles: 620 • Relevant studies: 166 • Study designs • RCTS: 3 • Cohort studies: 47 • Case series: 116 • Studies from US: 74

  8. Cardiac Malformations • State of the Science • 90 pregnancies in literature • 1 study provided infant outcomes beyond hospital stay • Maternal inclusion criteria poorly reported • No data on long term survival or neurologic outcomes Studies (n=9) • Pulmonary atresia with intact ventricular septum—2 case series • Aortic stenosis—8 case series • Hypoplastic left heart syndrome and intact atrial septum—3 case series

  9. Congenital Diaphragmatic Hernia State of the Science • Fetal inclusion criteria well-reported; 9 of 21 reported maternal criteria • Few measured outcomes beyond hospital stay (8/21) • Longest reported infant follow up: 24-48 months • Long term maternal outcomes addressed in 2 studies Studies (n=21) • 1 RCT • 3 prospective cohorts • 5 retrospective cohorts • 2 prospective case series • 10 retrospective case series

  10. Overview

  11. Overview

  12. Overview

  13. Outcomes reported

  14. Challenges for the field include: • Rare conditions with no method to consolidate new cases • Cases accrue slowly - innovations change the benefit equation • Clinical and research classifications of fetal anomalies vary • Spontaneous regression/stabilization occurs • Prognosis cannot be determined with high accuracy • Changes in the spectrum of disease reduces comparability to prior natural history studies of anticipated outcomes • Intervention techniques change rapidly • Higher SES patients are over-represented • Regionalization of care needs consideration • No formal plan for certified training programs exists

  15. Strategies to Reduce Evidence Gaps • Continue to develop consensus operational definitions • Enhance attention to common data elements • Use valid and reliable tools for outcomes • Support platforms for cooperative data sharing • Use analyses to help define equipoise for trials • Develop new methods for funding and cost sharing • Establish a consistent set of ethical standards for research in the field

  16. Challenges for Technical Brief Process • Content of the research: organizing classification, defining families, resisting urge to cross into outcomes • Access to fetal surgery: identifying pool of experts - able to establish via direct communication with those who publish • Training of providers: identifying sites - able to establish • Ethical aspects: balancing priorities for the report • Coverage: identifying accurate, available sources • Ongoing studies: documenting trials more achievable than other studies

  17. Technical Brief Conclusions • Limited RCT evidence • Literature dominated by case series (70% of studies) • Lack of clearly described maternal inclusion criteria and long term follow-up for infant or mother • Limited outcomes reported: • Literature not typical level of quality of studies or aggregate strength of evidence sufficient to guide care

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