Challenges in Evidence Synthesis for Gynecologic Care (Text Version)

Slide Presentation from the AHRQ 2011 Annual Conference

Challenges in Evidence Synthesis for Gynecologic Care

Slide Presentation from the AHRQ 2011 Annual Conference

On September 20, 2011, Katherine Hartmann made this presentation at the 2011 Annual Conference. Select to access the PowerPoint® presentation (130 KB). Plugin Software Help.

Slide 1

Challenges in Evidence Synthesis for Gynecologic Care

Katherine E. Hartmann, MD, PhD
Vanderbilt Evidence-based Practice Center
September 20, 2011

Slide 2

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.

Slide 3

Scenario #1: Overactive Bladder (OAB)

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.

Slide 4

Comparative Effectiveness Research (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.

Slide 5

Scenario #2: Chronic Pelvic Pain (CPP)

• 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.

Slide 6

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.

Slide 7

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.

Slide 8

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.

Slide 9

Scenario #4: Abnormal Uterine Bleeding (AUB)

• 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.

Slide 10

CER Approach for AUB

• Aligned framework, Key Questions (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.

Slide 11

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.

Slide 12

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.

Current as of December 2011

Internet Citation:

Challenges in Evidence Synthesis for Gynecologic Care. Slide Presentation from the AHRQ 2011 Annual Conference (Text Version). December 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/about/annualconf11/leavy_hartmann_nelson/hartmann.htm