Challenges in evidence synthesis for gynecologic care
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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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