Core Outcome Measures in Effectiveness Trials

Developing a core outcome set for female pelvic floor disorders (urinary incontinence, pelvic organ prolapse, childbirth perineal trauma and pelvic pain syndromes)

General Information

Summary:
Female pelvic floor disorders include: urinary incontinence (1 in 10 to 1 in 2 women), pelvic organ prolapse (1 in 10 women), childbirth perineal trauma (8 in 10 women who deliver vaginally) and pelvic pain syndromes (1 in 7 women).
Once a diagnosis has been established, treatment falls into three main types: surgical interventions, medical interventions, and holistic interventions.
Trials evaluating therapeutic interventions have reported many different outcomes resulting in significant outcome reporting bias and an inability to synthesise results across studies.

For example, Cochrane reviews evaluating surgical interventions for pelvic organ prolapse report outcomes variation limits the researcher’s ability to combine individual trials within a meta-analysis.

The development and use of core outcome sets would help to address these issues.

Objectives:

Produce, disseminate, and implement core outcome sets for female pelvic floor disorders, including urinary incontinence, pelvic organ prolapse, childbirth perineal trauma, and pelvic pain syndromes.

Protocol development in progress

Based on previously published protocols on developing core outcome sets, we aim to form an international steering group of healthcare professionals, researchers, and women with lived experience of pelvic floor disorders, in order to steer the development of these core outcome sets.

Potential core outcomes will be identified through an extensive literature review and entered into an international, multi-perspective online Delphi survey. All key stakeholders will be invited to participate.

Once core outcomes have been agreed the quality of potential outcome measures will be assessed. High quality outcome measures will be associated with core outcomes.

Contributors:
Principal investigator:
Stergios K. Doumouchtsis MSc, MPH, PhD, MRCOG
Consultant Obstetrician Gynaecologist and Urogynaecologist
Epsom & St Helier University Hospitals NHS Trust
Honorary Senior Lecturer, St George's University of London
Visiting Professor, University of Athens

(On behalf of the International Collaboration for the Development of Core Outcome Sets in Pelvic Floor Disorders)

Further Study Information

Current Stage:
Ongoing
Date:
April 2017 - December 2019
Funding source(s):
NIHR or other source funding will be sought.

Health Area

Disease Category
Gynaecology

Disease Name
Painful bladder syndrome (Interstitial cystitis)
Pelvic organ prolapse (POP)
Prolapse, incontinence, overactive bladder
Childbirth Trauma

Target Population

Age Range
0 - 100

Sex
Female


Nature / type of Intervention
Any

Method(s)

Delphi process
Interview
Literature review
Other
Systematic review

General methods: Developing a core outcome set for pelvic floor disorders.

Stage 1 Identifying Potential Outcomes

Systematic Review: Literature searches will identify randomised controlled trials evaluating interventions. A systematic review of the trial reports will catalogue outcomes and outcome measures.

Outcome Inventory: A comprehensive inventory of outcomes identified by the literature review and qualitative patient interviews will be developed prior to entering into the Delphi process.

Stage 2 Determining Core Outcomes

Delphi methodology: All stakeholders will be invited to participate in a process which assesses the extent of agreement (consensus measurement) and then resolves disagreement (consensus development). Repeated reflection and scoring increases the likelihood of whole and stakeholder group convergence towards consensus “core” outcomes.

Stage 3 Determining How Core Outcomes Should be Measured

Stage 3 (A): Quality Assessment: Once core outcomes have been agreed it is important to determine how they should be measured. An assessment framework (truth, discrimination, feasibility) will assess the quality of potential outcome measures. High quality outcome measures will be incorporated into the core outcome set.

Stage 3 (B): Stakeholder Consultation: A draft document summarising the background information, methodology, and results will be circulated and presented at the International Urogynecology Association and International Continence Society Congresses. Stakeholder feedback will be collated, reviewed, and incorporated into the finalised core outcome set prior to distribution.


Stakeholders Involved

Charities
Clinical experts
Consumers (caregivers)
Consumers (patients)
Governmental agencies
Patient/ support group representatives
Pharmaceutical industry representatives
Policy makers
Researchers
Service commissioners
Service providers
Service users

Study Type

COS for clinical trials or clinical research
COS for practice

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