19-1-2017
The CONSIDER Project
Development and validation of a Core Outcome Set for IAD
research
Prof. dr. Dimitri Beeckman, RN, PhD
University Centre for Nursing and Midwifery
Ghent University, BELGIUM
European Pressure Ulcer Advisory Panel
Chair of the Scientific Committee
INTRODUCTION
• Incontinence-associated dermatitis (IAD):
skin inflammation due to prolonged or
repeated exposure to urine and/or faeces
• Current prevention (and treatment)
consists of cleansing, moisturising and skin
protection
• Effectiveness of products and procedures:
What is known – What should be known?
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
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INTRODUCTION
What do we know?
Little
evidence on effectiveness
of
products and procedures
What should be known?
Which products and procedures are
effective in improving patient-important
outcomes?
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
COCHRANE REVIEW
Beeckman D, Van Damme N, Schoonhoven L, Van Lancker
A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van
den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S.
Interventions for preventing and treating incontinenceassociated dermatitis in adults. Cochrane Database of
Systematic Reviews 2016, Issue 11. Art. No.: CD011627.
DOI: 10.1002/14651858.CD011627.pub2.)
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
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RESULTS
• Low quality evidence, e.g. for the
effectiveness of a skin cleanser compared
with soap and water
• Overall findings of the included trials
suggest that IAD severity improved for all
leave-on products.
• Meta-analysis
not
suitable
due
to
heterogeneity in participant population,
skin care products, skin care procedure,
outcomes and measurement tools
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
DISCUSSION
•
•
•
Not possible to recommend any leave-on
product above another
No evidence on several participant
important outcomes (e.g. satifaction,
pain, adverse events)
Large
heterogeneity in participant
population, skin care products, skin care
procedure, outcomes and measurement
tools
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
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Dimitri Beeckman, RN, PhD
Jan Kottner, RN, PhD
Karen Van den Bussche, RN, PhD Candidate
Dorien De Meyer, RN, PhD Candidate
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
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19-1-2017
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
AIM
Scope and applicability
•
•
•
•
Population of interest: adults (>18
years) with IAD or at risk,
independently
from
any
geographical location or skin color
Intervention: clinical research, no
limitation
on
the
type
of
intervention
Setting: any setting were adults
with IAD or at risk are present
Area: international applicability
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
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19-1-2017
FRAMEWORK
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
METHODS
Phase 1 – Background,
preparation and process
o
International Steering Committee: 6
experts in dermatology, geriatrics,
wound care, trials and nursing, and
representatives of 2 patient
associations
o
Panelists from at least 3 continents:
100 healthcare researchers and
healthcare providers
o
Approval by Ethics Review
Committee, April 2016 (Ghent
University Hospital)
Phase 2 – Core Set of
Outcomes
Phase 3 – Core Set of
Measurement Instruments
Phase 4 – Dissemination and
monitoring
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
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METHODS
Phase 1 – Background,
preparation and process
o
Identification of existing outcomes
and measurements via
•
systematic literature review
•
consultation of the International
Steering Committee
•
interviews with patients
o
Consensus study about the core set
of outcomes using a Delphi procedure
Phase 2 – Core Set of
Outcomes
Phase 3 – Core Set of
Measurement Instruments
Phase 4 – Dissemination and
monitoring
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
METHODS
Phase 1 – Background,
preparation and process
•
Identification of available
instruments via a literature review
•
Evaluation of the methodological
quality of studies on measurement
properties
•
Overview of the measurement
properties
•
Consensus study about the core set
of measurements using a Delphi
procedure
Phase 2 – Core Set of
Outcomes
Phase 3 – Core Set of
Measurement Instruments
Phase 4 – Dissemination and
monitoring
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
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METHODS
Phase 1 – Background,
preparation and process
•
Dissemination and implementation
of the COS via publications and
presentations at conferences
Phase 2 – Core Set of
Outcomes
•
Monitoring emerging evidence and
revision of the COS if appropriate
Phase 3 – Core Set of
Measurement Instruments
Phase 4 – Dissemination and
monitoring
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
RESULTS
•
Longlist was generated (>1900 outcomes), based on:
― 246 relevant studies (literature search),
― 3 interviews with patients, and
― 6 experts consulted (International Steering Committee)
•
Shortlist:
Core Area
Life impact
•
Nr of domains
Examples
15
Self reported symptoms, independence (IAD
related), Quality of Life
Resource use /
economical impact
3
Cost-effectiveness and caregivers’ work
productivity
Pathophysiological
manifestations
42
Erythema, bleeding, exudate, scaling,
swelling, skin barrier properties
Delphi procedure is ongoing
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
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DISCUSSION
Challenges (1)
•
Use of terminology (outcome, measurement,
instruments, domains)
•
Decision on methodological framework (HOME
roadmap, COMET initiative, OMERACT)
•
Selection of relevant stakeholder groups for
the Delphi procedure
•
Patient involvement
condition, often in
patients and elderly)
(acute nature of
care-dependent ICU
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
DISCUSSION
Challenges (2)
•
Scope of the literature review and included studies (restrict to RCT’s and
systematic reviews? Broader?)
•
Which data to extract from the studies (what is an outcome in e.g. a
narrative review)
•
How to create a shortlist?
―
―
―
How to combine and collapse similar outcomes but still preserve content
without reducing meaning of the original outcomes?
When to create subcategories?
How to determine wording, description, and specificity of the
outcomes/domains (e.g. pain vs. pain intensity)?
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
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CONCLUSION
A global use of a COS in effectiveness trials
will contribute to:
•
•
•
•
Comparability between trials
Reliability and validity of outcome
(measurement instruments)
Patient- centered care
Clinical informed decision making
THE CONSIDER PROJECT: RESULTS OF A COCHRANE REVIEW ABOUT IAD PREVENTION AND TREATMENT AND THE DEVELOPMENT OF A CORE
OUTCOME SET FOR IAD RESEARCH – PROF. DIMITRI BEECKMAN, 2017
The CONSIDER Project
Development and validation of a Core Outcome Set for IAD
research
[email protected]
Prof. dr. Dimitri Beeckman, RN, PhD
University Centre for Nursing and Midwifery
Ghent University, BELGIUM
European Pressure Ulcer Advisory Panel
Chair of the Scientific Committee
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