Challenges in evidence synthesis for gynecologic care
Download
1 / 12

Challenges in Evidence Synthesis for Gynecologic Care - PowerPoint PPT Presentation


  • 73 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Challenges in Evidence Synthesis for Gynecologic Care' - lluvia


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
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