1 / 10

Capturing primary endpoints under MTN-016 Version 2.0

Capturing primary endpoints under MTN-016 Version 2.0. Lisa Noguchi, CNM, MSN February 24, 2014 Microbicide Trials Network Annual Meeting Bethesda, MD. Protocol. Version 2.0 distributed to sites on 2/14/2014 Updates aims Deletes product-specific language Omits developmental assessment

ashley
Download Presentation

Capturing primary endpoints under MTN-016 Version 2.0

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Capturing primary endpoints under MTN-016 Version 2.0 Lisa Noguchi, CNM, MSN February 24, 2014 Microbicide Trials Network Annual Meeting Bethesda, MD

  2. Protocol • Version 2.0 distributed to sites on 2/14/2014 • Updates aims • Deletes product-specific language • Omits developmental assessment • Updates analysis plan • Updated site-specific informed consent forms underway

  3. Revised aims

  4. Adverse pregnancy outcomes • Already being collected under Version 1.0 as secondary endpoints • Should be capturing these via careful chart review • Prenatal record • Records from labor ward or operating theatre • May also be noted on records from post-natal visit or even baby’s chart

  5. What do we mean by “adverse pregnancy outcomes”? • Delivery <37 completed weeks of gestation • Stillbirth or intrauterine demise (≥ 20 weeks) • Spontaneous abortion (< 20 weeks) • Ectopic pregnancy • Intrapartum or postpartum hemorrhage • Non-reassuring fetal status • Chorioamnionitis • Hypertensive disorders of pregnancy • Gestational diabetes • Intrauterine growth restriction

  6. Example: PO-2 CRF

  7. Pointers • Get help reading any terrible penmanship • Ask management team when you’re unsure – clinicians will be happy to help with de-identified records review • Know the lingo • “Chorioamnionitis” • “Sepsis in labour” • “Presented with prolonged rupture of membranes, fever and tenderness of the abdomen”

  8. On subjectivity… • Records may be unclear • Reduce subjectivity whenever possible • Consistency, consistency, consistency • Management team needs to deliver consistent guidance on interpreting pregnancy outcomes (e.g., in SSP) • If it’s unclear: ASK • Sites need to be diligent about consistent reporting

  9. Example • Patient is a G3 P2 who presented to the ward with term pregnancy in active labour at 11:00. History of anemia but otherwise uncomplicated course. She delivered precipitously in the triage room at 11:14. NSVD of healthy male infant, Apgars 9, 10. EBL 700 mL. Transferred to postnatal unit at 17:30.

More Related