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Update on iNESTand
CrM chart comparison studyJoseph B. Stanford, MD, MSPH, CFCMC
Director of Research, IIRRM
Professor and Director, Office of Cooperative Reproductive HealthDepartment of Family and Preventive Medicine
University of Utah
2015 July 15
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iNESTPurposeMethodsEnrollmentRecent resultsFuture
CrM chart review studyPurposeMethodsOpportunity
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iNEST
international NaProTechnology Evaluation and Surveillance of Treatment
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iNEST purpose
Evaluate outcomes (“success rates”) of NaProTechnology treatment for couples seeking treatment to have a live birth.Take advantage of natural variation in practice
to assess the impact of the use and timing of different interventions.
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iNEST methods
Prospective cohort of couplesNPT practice-based initiationMultiple centers, multiple countries
Follow all couples for 3 years regardless of treatment continuation or discontinuationObtain treatment data from NPT physicianMain outcome = live birthSecondary outcomes = low birthweight, preterm birth
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iNEST enrollment
Currently 672 couples!Last year 599
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Enrollment characteristics (2014)
Clinic location* #enrolled
mean age mean yrstrying
prior preg.
prior IVF
Clinton, NJ, USA 161 34.7 2.6 52.8% 8.7%Salt Lake City, UT, USA 85 31.6 2.5 30.6% 2.4%Gardner, MA, USA 45 32.7 2.8 48.9% 4.4%Leamington Spa, UK 150 36.5 4.0 16.7% 14.0%Etobicoke, Ontario, Canada 104 33.5 2.4 44.2% 6.7%Baton Rouge, LA, USA 17 32.2 3.3 47.1% 0%Charlottesville, VA, USA 14 31.9 1.9 50.0% 0%TOTAL 599 34.2 2.7 37.4% 7.7%Missing from total na 1.2% 31.4% 36.4% 31.6%
*Clinics in the following sites have each contributed
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Events in study (2014)
Clinic location* Reprosurgery
# clinicvisits
Preg Birth
Clinton, NJ, USA 8.4% 1.5 46.0% 37.3%Salt Lake City, UT, USA 9.4% 6.7 48.2% 38.8%Gardner, MA, USA 13.3% 8.5 26.7% 24.4%Leamington Spa, UK NR NR 19.3% 19.3%Etobicoke, Ontario, Canada 13.5% 7.5 46.2% 39.4%Baton Rouge, LA, USA 0% NR 35.3% 35.3%Charlottesville, VA, USA 7.1% 5.6 7.1% 7.1%TOTAL 8.7% 5.0 35.4% 30.4%Missing from total 80.8% 33.9% 40.2% 39.9%
*Clinics in the following sites have each contributed
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Conception leading to live birth by time previously trying to conceive
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Conception leading to live birthby prior live birth (2014)
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Birth weight by treatment at conception (n=189)
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Gestational age by treatment at conception (n=193)
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Live births and newborn hospital stay (n=333 and n=195, respectively)
0
10
20
30
40
50
60
70
80
90
100
Live Birth/Total Pregnancies Newborn Hospital Stay > 7 Days
Perc
ent (
%)
Pregnancy Outcomes
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Follow-up questionnaire response rates
2014 2015Qnrs sent to women 117 34Women’s response rate 61% 50%
Qnrs sent to men 113 34Men’s response rate 42% 24%
Women, % pregnant 52% 65%
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Follow-up questionnaire response rates
2014 2015Qnrs sent to women 117 34Women’s response rate 61% 50%
Qnrs sent to men 113 34Men’s response rate 42% 24%
Women, % pregnant 52% 65%
2014: compensated2015: not compensated
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iNEST current and future
No funding currently!Actively pursuing additional fundingLong-term sustainability?
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iNEST proposed revamp
Rename and broadenLevels 1, 2, 3, 4
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Rename and expand
Any restorative reproductive medicine approachMore comparative data
Same or similar acronym?eNEST = extended natural evaluation of
systems of treatment (?!)
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Level 1 basic outcome data
Yearly reporting of core dataFor each couple starting treatmentAge of woman and manTime attemptingPrior treatments (yes/no)Prior live birth and pregnancy (yes/no)Surgery (date and basics)Pregnancy dates and outcomes
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Level 1: basic outcome data
Does not require individual consent of couplesAnnual report (individual clinics not identified)Analogous to SART, HFEA, ESHRE, othersHolding our profession (RRM) accountable to
ourselves and to the public
Web-based or spreadsheet reportingCould be facilitated by RRM-EMRCould be expanded to other RRM outcomes
eventually
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Level 2: prospective enrollment
Consent individual couples prospectivelyLevel one data, plusDetailed questionnaire data at enrollment and at
follow-upLearn what happened to patients who disappeared!
This is the current iNEST study designCould be facilitated by RRM-EMR
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Level 3: cycle-based data
Enroll couples prospectivelyLevel 1 and 2 data plusCycle-specific treatments used, charting, and
online cycle reviews shared between patient and clinician, with automatic data transferCould be greatly facilitated by RRM-app
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Level 4: randomized trials
Level 2 or 3 plus Invite suitable patients to enroll in randomized
trials, e.g., Early versus delayed surgical interventionLetrozole versus clomiphene without PCOSDietary intervention (specific or general)etc.
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How to fund this?Level 1: participating physicians and clinicsLevel 2: external funding for follow-up
questionnairesLevel 3: fees from app users?Level 4: requires major external funding
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Funding to date
Atlas FoundationUniversity of Utah internalPrimary Children’s Medical Foundation,
Salt Lake City, UTSt. Augustine FoundationMary Cross Tippmann FoundationWomen’s Reproductive Health
Foundation
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Creighton Model chart review study (clinical validation)
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CrM charts reflect underlying fertility status
Figure 1. CrMS chart of a cycle from a woman with normal fertility.
Figure 2. CrMS chart of a cycle from a woman with infertility.
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CrM chart comparison purpose
Evaluate sensitivity, specificity, positive predictive value, negative predictive value, and proportion of subfertility correctly predicted by expert Creighton Model chart reviewers (medical consultants, practitioners, and educators).Proof of principle
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Chart study methods
Approximately 30 matched pairsiNEST = subfertile or “infertile”CEIBA = normally fertileMatched by age, parity
First 100 days of charting (without intercourse)Randomly ordered
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Chart study methods
Volunteers review via online questionnaireFirst answer questions about training and
experience with Creighton Model charting and other types of chartingOptional anonymous or acknowledged
Then review each chart blindlyQualitatively assess specific parametersClassify each as subfertile or normally fertile
We estimate total review time = 6 hours
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Chart study analysis
Analyze with 2x2 tables for sensitivity, specificity, etc.We will also look objectively at each parameter
statisticallyMenstrual flow scoreMucus cycle scoreNumber of days of brown bleedingDuration of postpeak phaseetc.
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Watch for email announcement!
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Every kind of support makes a difference!
Review for the chart studyBecome a member of IIRRMGive a webinarWork on a committeePresent to physicians in your areaSponsor a conference in your areaDonateMentor
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Office of Cooperative Reproductive Health
Update on iNEST�and�CrM chart comparison studySlide Number 2iNESTiNEST purposeiNEST methodsiNEST enrollmentEnrollment characteristics (2014)Events in study (2014)Conception leading to live birth �by time previously trying to conceiveConception leading to live birth�by prior live birth (2014)Birth weight by treatment at conception (n=189)Gestational age by treatment at conception (n=193)Live births and newborn hospital stay (n=333 and n=195, respectively)Follow-up questionnaire response ratesFollow-up questionnaire response ratesiNEST current and futureiNEST proposed revampRename and expandLevel 1 basic outcome dataLevel 1: basic outcome dataLevel 2: prospective enrollmentLevel 3: cycle-based dataLevel 4: randomized trialsHow to fund this?Funding to dateCreighton Model chart review study (clinical validation)CrM charts reflect underlying fertility statusCrM chart comparison purposeChart study methodsChart study methodsChart study analysisWatch for email announcement!Every kind of support makes a difference!Slide Number 34Office of Cooperative �Reproductive Health