IMPART Dubai, 2013. Workshop on Quality Management in ART Centers.

1. IMPART, Dubai 2013
IVF Business Strategies in
QM Models
Strategies to Decrease Dropout in IVF
Sandro C. Esteves, MD, PhD
Director, ANDROFERT
Fabiola C. Bento, BA, MBE
Quality Manager, ANDROFERT
Andrology & Human Reproduction Clinic - Campinas, Brazil

2. Is Your Clinic Good?
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 2
2013 DECEMBER

3.  Established 2005
 100 babies born
 Few credentials experience
 IVF first treatment line
 No poor responders
 Record of errors/patient complaints
 High multiple PR
 Advertise a lot
 Established1994
 >1,000 babies born
 Lots of credentials/experience
 All treatment options available
 Individualized approach
 Rare errors/patient complaints
 Low multiple PR
 Educational marketing
Doctor Look Good
PR/cycle = 50%
Doctor Look Bad
PR/cycle = 30%
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 3
2013 DECEMBER

4. Is Your Clinic Good?
Prove it!
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 4
2013 DECEMBER

5. Contents
ANDROFERT
androfert.com.br
Numbers and Causes of Dropout
Dropout hotspots
IVF Quality Indicators in QM models
Strategies to improve compliance
and decrease dropout in IVF
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 5
2013 DECEMBER

6. Infertility Patient Journey
Having
Difficulty
Conceiving
Treated by
ObGyn
Treated
by
Infertility
Specialist
45 never seek medical treatment1 100
10 discontinue treatment before
finishing first line therapy2
14 finish 1st line therapy and then
discontinue2
11 who come to IS for initial
consultation do not initiate
treatment2
Up to 12 who start treatment drop out
before completing it3
1Boivin J, et al. Hum Reprod 2007;6:1506; 2Data on file, ObGyn Research
2003, EMD Serono; 3Domar AD. Fertil Steril 2004;81:271
55
31
20
8
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 6
2013 DECEMBER

7. Business
opportuniti
es
Awareness
about
infertility
Communicati
on with
referring
physicians
ART
process
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 7
2013 DECEMBER

8. How good is your communication?
Patient Awareness &
Education
Web, magazines, radio,
TV, newspaper, healthcare
professionals, etc.
Referral physicians
When to refer to IS
When/how often update
When to refer patients
back
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 8
2013 DECEMBER

10. Dropout rate of patients
undergoing IVF
In a 2005 IVF study from the UK8, per-cycle discontinuation rates
ranged from 25-42% and increased with each subsequent cycle
25%
33%
40% 42%
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
1 2 3 >=4
cycle number
% not pregnant and d/c Tx
n=246 n=183 n=184 n=119
8 Adapted from Rajkhowa et al. Reasons for discontinuation of IVF treatment: a
questionnaire study. Hum Rep 2005;21:358-363
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 10
2013 DECEMBER

11. Why Dropout is Critical
Discontinuation is a primary determinant of
the effectiveness of treatment because it
attenuates optimum clinical benefit (WHO,
2003)
The NICE guidelines in the UK recommended
that compliance should be monitored for audit
purposes and to provide recommendations for
care implementation (National Institute for
Clinical Excellence, 2004)
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 11
2013 DECEMBER

12. 22 studies that
sampled 21,453
patients from
eight countries
Identifiable Reasons (%) 29
11
17 19
24
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 12
2013 DECEMBER

13. What do they mean?
Psychological
burden
Cannot stand it; too anxious or depressed to continue; too much
stress; psychological aspects come first than physical
Physical
burden
Poor tolerance to physical side of treatment; treatment too
aggressive; retrieval too painful; side effects from treatment; could
not stand all the injections; could not stand side effects of
medication;
Rejection of
treatment
Ethical objections to ICSI; fear of abnormal child; fear of
complications; getting nervous about possible long-term effects of
treatment; not interested in treatment; reject treatment in general;
rejected IVF treatment
Organization
problems
Therapeutic programme difficult to integrate with work
Clinic reason Insufficient or poorly formulated explanations about healthcare or
fertility problem; poor management of psychological aspect
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 13
2013 DECEMBER

14. Severe Male Infertility a Risk Factor
Fear and negative treatment
attitudes
Sperm retrieval and sperm quality
Communication problems with
partner
Hazard Ratio 4.80 (95% CI: 1.63-14.13)
Verberg et al. Why do couples drop-out from IVF treatment: A prospective
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 14
2013 DECEMBER
cohort study. Hum Rep 2008;23:2050-5

15. Hotspots to decrease dropout in IVF
Patient
Treatment
continuation
Clinic
Treatme
nt
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 15
2013 DECEMBER

17. 
Development of 298 quality indicators

Twenty-four indicators selected based on
consensus of importance; Six quality dimensions
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 17
2013 DECEMBER

18. Consensus Quality Indicators
Safety
• Complications, Errors/Mistakes, Procedures/Techniques/Medication
Effectiveness
• Live birth rates according to age groups and time periods
Patient centeredness
• Psychological counseling/support available, individualized treatment, patient
discussion groups, information
Efficiency
• Diagnostic work-up prior to IVF, Clinic website with information, electronic database
for data extraction and analysis, number of care providers relative to number of
patients
Timeliness
• Focus on urgent consultation and waiting time; average duration of waiting time
before and during treatment, and after failed attempt
Equity
• Explicit criteria for treatment indication, vision of the clinic concerning ethical
limitations, protocols in accordance with international/regulatory guidelines
Adapted from Dancet et al. HR 2013
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 18
2013 DECEMBER

19. Top 3 Quality Indicators of Infertility Care
How professionals and patients perceive them?
Dancet et al.
Hum Reprod 2013
0% 20% 40% 60% 80% 100%
Patients
Nurses
Doctors/embryologists
Safety
Effectiveness
Patient-centeredness
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 19
2013 DECEMBER

21. Procedures/
Techniques/
Medication
#1: Safety
Errors/Mistak
es
• Apply validated
procedures/tec
hniques,
prescribe
medication with
better safety
profile
• Implementation
of quality
management
program (eg.
ISO 9001)
Complication
s
• Avoid OHSS
• Identification of
patients at risk,
fine-tuning
COS, GnRHa
+ Vitrification +
FET
Patien
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 21
2013 DECEMBER
t
Treatment
continuation
Clinic Treatme
nt

22. Multiparity rate
• Cumulative LBR
with SET or DET
• Cryopreservation
Program
• eSET
#2: Effectiveness
No. live birth
over a certain
time period
• Cumulative LBR
• Cryopreservation
Program
No. patients
who had a live
birth after 3
cycles
• Proper workup
and preparation
prior to IVF
• Definition
treatment strategy
• Technique/Proced
ure
• Cumulative LBR
Patien
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 22
2013 DECEMBER
t
Treatment
continuation
Clinic
Treatmen
t

23. #3: Patient-centeredness
Individualize
d care
• Reference
doctor
• Nurse care
• Participation in
decision-making
process
Information
• Professionals
• Website
• Leaflets
• Manuals
• Videos
• Group
discussion
Emotional
support
• Psychologist
• Identification
who are at risk
by applying
specific
questionnaires
• Counselor/Nur
se
Patien
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 23
2013 DECEMBER
t
Treatment
continuation
Clinic Treatmen
t

24. Our method
1. Stress Alleviation
2. Patient Education
3. Male Infertility
4. Cumulative Pregnancy Rate
5. Total Quality Management
Location
Complexity
Tertiary Infertility Center; Referral Center for Male Infertility
Category Private
Foundation
Staff
Workload
Campinas, Sao Paulo, Brazil
1997
14 Gynecologists, 3 Urologists, 4 Anesthetists, 3 Embryologists, 2
Lab Technicians, 4 Nurses, 1 Psychologist, 1 Pharmacist, 1
Nutritionist, 1 Acupuncturist, 1 Quality Manager, 4
Administrative personnel; 1 IT specialist, etc.
> 2,000 couples per year

25. #1. Stress Alleviation
Socio-emotional Support
Health Care Program
Integrated team of health
professionals
Psychologist
Nutritionist
Acupuncturist
Rejane Ganzaroli
Psychologist, ANDROFERT
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 25
2013 DECEMBER

26. Positive Impact of Psychological
Interventions on Pregnancy Rates
Hämmerli K et al. Hum. Reprod. Update 2009;15:279-295
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 26
2013 DECEMBER

27. #1. Stress Alleviation
Medication Strategies
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 27
2013 DECEMBER

28. ANDROFERT
androfert.com.br
#1. Stress Alleviation
No Pain Gamete Retrieval
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 28
2013 DECEMBER

29. #1. Stress Reduction: Doctor and
Nursing care
o Each patient/couple has reference doctor
o Each patient/couple has a reference nurse
o Teaching (IVF steps, medication)
Misconceptions addressed before treatment start
o Individualized patient agenda and routines
o Precise description of Medication plan
o Schedule appointments
o Informed consents
o Hotline (24h/day; 7 days/week)
o Follow-up:
– Up to live birth (Registry report)
– Return visit (non-pregnant)
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 29
2013 DECEMBER

30. Next employee: Nurse
A high quality IVF
program has
excellent well-trained
nurses
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 30
2013 DECEMBER

31. #2. Patient Education
On-site and
Web-based IVF
education
Material for download
 Medication timetables
 Consents
 Procedure instructions
 Medication instructions
IVF manual
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 31
2013 DECEMBER

32. #3. Male Infertility Care
Team of Male Infertility
Specialists
Dedicated Andrology
Laboratory and
Therapeutic Sperm Bank
On-site Sperm Retrieval
Procedures
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 32
2013 DECEMBER

33. #4. Cumulative live birth rates
Female Age ≤38 +25.0%
40.4% 48.0%
ET #3
(FET) 49
ET #2 (FET)
239
ET #1 (fresh)
822
50.5%
+18.8%
332/822 63/239 17/49
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 33
2013 DECEMBER

34. #4. Cumulative Live Birth Rate
Blastocyst culture Vitrification
IVF Lab and
associated
Areas
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 34
2013 DECEMBER

35. #5. Quality Management
Fabiola Bento, MBE
Quality Manager, ANDROFERT
ANDROFERT
androfert.com.br
Leadership
Establish unity of purpose
and direction of the
internal environment
Create an environment
where people are fully
involved in achieving the
organization’s objectives
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 35
2013 DECEMBER

36. #5. Quality Management
ANDROFERT
androfert.com.br
To Improve adherence to IVF
Total Quality Management
A high quality IVF program focuses on
how the business is managed
1. Focus on patient
2. Improve communication
3. Continual improvement
4. Leadership
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 36
2013 DECEMBER

37. #5. Quality Management
Safety
ANDROFERT
androfert.com.br
• Strict compliance
with regulations
• Standardized SOP’s
• Non-conformities
control and treatment
• QMS program
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 37
2013 DECEMBER

38. #5. Quality Management
Effectiveness
• Systematic
monitoring of
Quality Indicators
• QMS program
• Offering complete
treatment
package to
patients
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 38
2013 DECEMBER

39. ANDROFERT
androfert.com.br
#5. Quality Management
Patient-centeredness
• Standardization of
medical evaluation to
guarantee complete
investigation and
individualized treatment
• Good communication
system with patients
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 39
2013 DECEMBER

40. #5. Quality Management
Patient-centeredness
• Continual training
program for nurses
• Satisfaction
Questionnaires
ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 40
2013 DECEMBER

41. ANDROFERT
androfert.com.br
ANDROFERT
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
SC ESTEVES, 41
2013 DECEMBER

42. Thank You
obrigado