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Challenges in Evidence Synthesis for Gynecologic Care. Katherine E. Hartmann, MD, PhD Vanderbilt Evidence-based Practice Center September 20, 2011. Women’s Health Research . Delayed entry into federally funded research Industry dominated early clinical trials

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challenges in evidence synthesis for gynecologic care

Challenges in Evidence Synthesis for Gynecologic Care

Katherine E. Hartmann, MD, PhD

Vanderbilt Evidence-based Practice Center

September 20, 2011

women s health research
Women’s Health Research
  • Delayed entry into federally funded research
  • Industry dominated early clinical trials
  • Tradition of databases & observational studies
  • Diagnostic dilemmas
  • Lack of consensus diagnoses
  • Use of intermediate measures predominated
  • Late uptake of patient reported outcomes
scenario 1 overactive bladder
Scenario #1: Overactive Bladder

Historically: detrusor instability, urge incontinence

Anticholinergics

Creation of a “label” within advertising campaign

  • Indication marketed to providers, patients, & payers
  • Norm established and drive for treatment created

Research reported as relative improvements

  • Drugs approved on this basis
  • Absolute effects extremely modest
  • Side effects common and adherence untested
cer approaches for oab
CER Approaches for OAB
  • Documented history of the “OAB” indication
  • Systematically reviewed prevalence literature
  • Conducted meta-analysis of absolute effects: voids per day, incontinence episode per week
  • Emphasized on patient satisfaction/PROs
  • Attended to harms
  • Noted head-to-head comparisons within company
  • Included behavioral approaches in review
scenario 2 chronic pelvic pain
Scenario #2: Chronic Pelvic Pain

Large descriptive literature, numerous case series

Extreme heterogeneity:

  • Definition of condition
  • Inclusion criteria
  • Conditions excluded
  • Clinical diagnosis of exclusion

Short-term outcomes for a long-term condition

No sham surgery comparison groups

cer approaches in cpp
CER Approaches in CPP

Restricted to non-cyclic

Documented expected prevalence of comorbidities

Grouped findings along three axes:

  • Intervention
  • Inclusion methods
  • Outcomes (category and length of follow-up)

Emphasized subsequent medication and surgery

Noted absence of natural history and trajectory studies

scenario 3 uterine fibroids
Scenario #3: Uterine Fibroids

Size, number, position poorly predict symptoms

  • Imaging outcomes problematic

Patient reported outcomes key

Masking of assessors rare

Fertility desires influence modality

  • Age distributions of studies matter
  • Reproductive outcomes non-ignorable

Follow-up too short to capture trajectory

cer approach for fibroids
CER Approach for Fibroids
  • Discussed evolution of imaging and relation of characteristics to symptoms
  • Addressed outcomes with relevance to reproductive intent – highlighted gaps
  • Covered topic of postmenopausal fibroids and HT
  • Extracted data about recurrence and timing of recurrence
  • Noted lack of natural history and trajectory studies
  • Summarized importance of symptom bother
scenario 4 abnormal uterine bleeding
Scenario #4: Abnormal Uterine Bleeding
  • Multiple biologically distinct pathways to AUB
  • Many terms imply known biology are applied based only on symptoms
  • Evaluation paradigms lack uniformity
  • Failure to respond to treatment often used as part of implicit diagnostic process
  • Distinctive primary care and surgical pathways
  • Little literature that informs sequence of care
cer approach for aub
CER Approach for AUB
  • Aligned framework, KQs, and methods with new consensus terminology
  • Aimed at informing the primary care frontline rather than surgical “end of the line”
  • Restricted to clinical trials of currently available modalities (drugs and surgeries)
  • Used “measles plots” and “multiplication tables” to illustrate the lack of common methods
cross cutting recommendations
Cross Cutting Recommendations
  • Compile total participants per intervention/outcome
  • Exclude observational studies from effectiveness
  • Quantify the gaps (n, % of studies lacking features, measles charts, other visuals)
  • Document entangled co-morbidities
  • Focus on factors that modify applicability
  • Truncate search to reflect contemporary practice
remember importance of mapping gaps
Remember Importance of Mapping Gaps

Clearly delineating gaps invites:

  • Improved education of patients
  • Greater disclosure of risks/poorly defined risks
  • Enhancement of research methods
  • Design and conduct of research to fill gaps
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