EVIDENCE BASED FERTILITY PRACTICE

Dr. Priya Bhave Chittawar

SCOPE OF THE PRESENTATION

Need for information Sources EBM: the steps Examples Towards wisdom based medicine

What should I do? What should I not do? What is the correct way to

treat/diagnose/operate/correct What is the incorrect way to

treat/diagnose/operate/correct

Ask Mom….

Ask the Teacher…

Read a book….

Ask a friend…

Turn to God?

It is important to ask. It is important to ask the right questions It is important to ask the right person

“Seek and you shall find……………”

Need for Information

Our daily need for valid information regarding diagnosis, prognosis , therapy and prevention

Three times per day for outpatients Upto five times per day for inpatients.

( Osheroff et all:Physicians information needs: Analysis of questions posed during clinical teaching. Ann Int Med 1991; 114:576-8)

INFORMATION OVERLOAD

Alternatives to EBM Eminence based medicine Vehemence based medicine Eloquence based medicine Providence based medicine Diffidence based medicine Nervousness based medicine Confidence based medicine

Seven alternatives to evidence based medicine BMJ. 1999 December 18; 319(7225): 1618.

Why Evidence Based Fertility Practice? Infertility treatments have limited

success Costly Most choices are based on statistical

probabilities Female age is a critical factor Ethnic differences

EXAMPLE 1

Metformin in Polycystic Ovarian Syndrome Insulin resistance Metformin is an insulin sensitizer Large number of small trials recommended

use to improve insulin sensitivity, ovulation rates, pregnancy rates

Cochrane review( Lord 2003): Metformin is an effective intervention in women with PCOS

Larger RCTs by Legro( 2007), Moll (2006) and Tang( 2007)

Updated Cochrane review ( Tang 2009):

“Adding Metformin to Clomiphene or Metformin alone does not improve Live birth rates”

How to practice EBM Ask: an answerable question Acquire: the best evidence to answer that

question Appraise: critically the evidence for its

validity, impact, size of effect and applicability

Apply: integrate the clinical scenario, evidence with the patients expectations and background

Asses : the outcome

Ask

P: Who is the Patient or problem being addressed?

I: What is the intervention or exposure? C: What is the comparison group? O: What is the outcome?

EXAMPLE 2

In ovulation induction for anovulatory infertility, HCG is routinely given as ovulation trigger

Better timing? Preventing Luteinized unruptured follicle

syndrome? Better luteal phase?

What is the evidence?

Ask

Does triggering ovulation with HCG help get more pregnancies?

In anovulatory women with PCOS, does triggering ovulation with HCG result in better pregnancy rate compared to spontaneous ovulation?

Ask Acquire Appraise Apply Analyze

Acquire

Journals : Human Reproduction, Human Reproduction update, Fertility Sterility

MEDLINE Pubmed Cochrane database

Acquire

Two randomized controlled trials George et al: Compared spontaneous

ovulation versus hCG triggered ovulation in anovulatory women treated with Clomiphene citrate. No statistically significant difference in ovulation and pregnancy rates.

( FertStert April 2007)

Yilmaz et al : No difference in pregnancy rate or ovulation rate in the two groups.

( FertStert 2006)

Ask Acquire Appraise Apply Analyze

Appraise

Appraise

Chance: Bias: Systematic error that deviates

results from the truth

Type 1: shows a difference when there is none

Type 2: Shows no difference when there is one.

Reducing bias and random errors Adequate sample size Having a control group Randomization Allocation concealment Blinding

Sequence Generation

Allocation Blinding Attrition Analysis

George2007

Random numbers

Consecutively Numbered sealed opaque envelopes

Open 1 in Rx arm2 in control

Completer analysis

Yilmaz2006

Table of random numbers

Opaque envelopes

Sonologist blinded

none Intention to treat

Internal Validity: If the conclusions are reliable

External validity: If the conclusions are applicable to a different population

Synthesize the evidence:

Reviews

Meta analysis

How to interpret a meta analysis?

Graphical display in the form of a Forrest plot

All the contributing trials mentioned with the number of subjects

Absence of evidence or evidence of absence?

There is absence of evidence to recommend giving HCG as ovulation trigger.

Financial aspect

Ask Acquire Appraise Apply Analyze

Apply results to your clinical practice. Find more evidence Generate more evidence Financial aspect

Ask Acquire Appraise Apply Analyze

Should I use the latest treatment on the block?

Wont I be depriving my patients of the ‘Benefits’ of this new magical drug/intervention if I dally?

Innocent until proved guilty?

Guilty until proved innocent?

Primum Non Nocere…….

First do no harm!

What is Evidence based healthcare?

Integration of research evidence, clinical expertise and patient values.

When you know a thing, to hold that you know it;

And when you don’t know a thing,

To allow that you don’t know a thing,

That is wisdom

Confucious

"From inability to let well alone,From too much zeal for what is new, and contempt for what is old,From putting knowledge before wisdom, science before art,and cleverness before common sense,...From treating patients as cases, andFrom making the cure of a disease more grievous than its enduranceGood Lord deliver us."

Thank You….