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So Much Evidence  What is Next
P articipants I ntervention Group (IG) &  C omparison Group (CG) O utcome I G CG + - + - D C B A R epresentative? Allocation? Selection? Maintenance of allocation? VALIDITY M aintenance?   treated equally?  compliant?   M easurements   b lind subjective? OR   o bjective? QUESTION: A llocation?   Randomised?   comparable groups? Measurement of outcomes? DESIGN:
Process of Randomisation  Participants R a n d o m  l  y  A s s i g n  e  d Intervention Group Control Group Follow-up Follow-up Intervention Group Control Group O u t c o m e  C o m p a r e   d
Assessed for eligibility (n= 245) Excluded (n= 15) Not meeting inclusion criteria (n=7)  Refused to participate (n=5) Social reasons (n=3) Received IUI (110) Analyzed (n=110) Cycles cancelled (n=5) Inadequate response (n=4) Hyper-response (n=1) Group I (n=115) received Merional + CC Cycles cancelled (n=8) Inadequate response (n=6) Hyper-response (n=2) Group II  (n=115)  received Merional alone  Received IUI (107) Analyzed (n=107) Allocation Analysis Follow-Up Enrollment Randomized (n=230 )
The best evidence for different types of question Level Treatment Prognosis Diagnosis I Systematic Review of … Systematic Review of … Systematic Review of … II Randomised trial Cohort Cross sectional III
systematic reviews  Alderson, 2005
Too much information 5,000? per day 1,500 per day 55 per day
OBGYN in Pubmed ,[object Object],[object Object]
Ready Made EBOG ,[object Object],[object Object],[object Object],[object Object]
“ I don’t know…” “ I don’t really care about  all of this research stuff…” “ I just want to take care of patients…” Unnamed Ob-Gyn Resident Still There is a Problem
Many “Leaks” from research to practice If 80% achieved at each stage then 0.8 x 0.8 x 0.8 x 0.8 x 0.8 x 0.8 x 0.8 = 0.21 Aware  Accept  Target  Able  Recall  Agree  Done  Valid Research
(a*+) (b+) (c*) (d) Minimum clinical Important difference No difference Another Problem : Which are (i) statistically significant * and    (ii) Clinically significant +?
 
So ,[object Object],[object Object]
Individual
The EB M  Model Sackett et al., 1997 EBP Best Evidence Client Values and Expectations Practitioner’s Individual Expertise
EB P  Model Institution state and circumstances Clinical Expertise Client Preferences and actions Research Evidence
But still Knowledge needs to be managed much more effectively than it has been in the past
“ Evidence Base” Community ,[object Object]
“ Evidence Base” Community ,[object Object],[object Object],[object Object]
Unexplained Infertility Spontaneous intercourse?? IUI alone IUI + O.I Timed intercourse O.I alone
Ines Trial IUI + O.I IVF + sET NC IVF
Timing of IUI ,[object Object],[object Object],[object Object],[object Object],[object Object]
“ Evidence Base” Community ,[object Object],[object Object],[object Object],[object Object],[object Object]
Moving Methodology Forward ,[object Object],[object Object],[object Object]
Steps For Evidence Base Community Implementation Information sharing with decision Makers Organization & Fund raising Clinical Care Improvement Training on EBP’s, supervision, consultation and support  Engagement Strategic plan Focus on  outcomes that clients value. Improved Women Health Clinicians, consumers, Stakeholers  Feedback  :Efficiency & Effectiveness
Elements Important (Fixsen et al, 2005) ,[object Object],[object Object],[object Object]
So ,[object Object],[object Object],[object Object],[object Object]
Hence
[object Object],[object Object],[object Object],[object Object]

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So much evidence 1

  • 1. So Much Evidence What is Next
  • 2. P articipants I ntervention Group (IG) & C omparison Group (CG) O utcome I G CG + - + - D C B A R epresentative? Allocation? Selection? Maintenance of allocation? VALIDITY M aintenance? treated equally? compliant? M easurements b lind subjective? OR o bjective? QUESTION: A llocation? Randomised? comparable groups? Measurement of outcomes? DESIGN:
  • 3. Process of Randomisation Participants R a n d o m l y A s s i g n e d Intervention Group Control Group Follow-up Follow-up Intervention Group Control Group O u t c o m e C o m p a r e d
  • 4. Assessed for eligibility (n= 245) Excluded (n= 15) Not meeting inclusion criteria (n=7) Refused to participate (n=5) Social reasons (n=3) Received IUI (110) Analyzed (n=110) Cycles cancelled (n=5) Inadequate response (n=4) Hyper-response (n=1) Group I (n=115) received Merional + CC Cycles cancelled (n=8) Inadequate response (n=6) Hyper-response (n=2) Group II (n=115) received Merional alone Received IUI (107) Analyzed (n=107) Allocation Analysis Follow-Up Enrollment Randomized (n=230 )
  • 5. The best evidence for different types of question Level Treatment Prognosis Diagnosis I Systematic Review of … Systematic Review of … Systematic Review of … II Randomised trial Cohort Cross sectional III
  • 6. systematic reviews Alderson, 2005
  • 7. Too much information 5,000? per day 1,500 per day 55 per day
  • 8.
  • 9.
  • 10. “ I don’t know…” “ I don’t really care about all of this research stuff…” “ I just want to take care of patients…” Unnamed Ob-Gyn Resident Still There is a Problem
  • 11. Many “Leaks” from research to practice If 80% achieved at each stage then 0.8 x 0.8 x 0.8 x 0.8 x 0.8 x 0.8 x 0.8 = 0.21 Aware Accept Target Able Recall Agree Done Valid Research
  • 12. (a*+) (b+) (c*) (d) Minimum clinical Important difference No difference Another Problem : Which are (i) statistically significant * and (ii) Clinically significant +?
  • 13.  
  • 14.
  • 16. The EB M Model Sackett et al., 1997 EBP Best Evidence Client Values and Expectations Practitioner’s Individual Expertise
  • 17. EB P Model Institution state and circumstances Clinical Expertise Client Preferences and actions Research Evidence
  • 18. But still Knowledge needs to be managed much more effectively than it has been in the past
  • 19.
  • 20.
  • 21. Unexplained Infertility Spontaneous intercourse?? IUI alone IUI + O.I Timed intercourse O.I alone
  • 22. Ines Trial IUI + O.I IVF + sET NC IVF
  • 23.
  • 24.
  • 25.
  • 26. Steps For Evidence Base Community Implementation Information sharing with decision Makers Organization & Fund raising Clinical Care Improvement Training on EBP’s, supervision, consultation and support Engagement Strategic plan Focus on outcomes that clients value. Improved Women Health Clinicians, consumers, Stakeholers Feedback :Efficiency & Effectiveness
  • 27.
  • 28.
  • 29. Hence
  • 30.

Editor's Notes

  1. Enrollment - Treatment Allocation - Follow-up - Data Analysis