SAVE THE DATE: CSG-COUSIN Meeting 2017 - 9th and 10th January 2017 - Berlin, Germany
SECOND NEWSLETTER COCHRANE SKIN GROUP - CORE OUTCOME SET INITIATIVE
You don´t know what a
At least eight Core Outcome Set (COS) initiatives for specific
COS is? Follow this link!
dermatological diseases (atopic eczema, cutaneous leishmaniasis,
vitiligo, vulval skin disorders, appearance of facial ageing, incontinence-associated dermatitis,
venous leg ulceration, and ulcers (pressure)) have been developed within the last eight years and
were listed in the COMET database (http://www.comet-initiative.org/). These initiatives use(d)
several methodological approaches in terms of outcome selection, stakeholder involvement,
consensus methods and implementation. Therefore, a platform for COS initiatives in dermatology
was considered useful to support and integrate the different initiatives, to develop methodological
approaches and recommendations further, and to set a quality standard for COS development and
application in dermatology. As an umbrella initiative, the Cochrane Skin Group Core Outcome Set
Initiative (CSG-COUSIN) has been launched for COS development and implementation in
dermatology. The kick-off meeting of CSG-COUSIN was held in March, 2015 in Dresden, Germany
(click here for the Meeting-Report). Since the inaugural meeting fourteen COS initiatives have been
initiated in cooperation with CSG-COUSIN, are underway or affiliated to CSG-COUSIN. Please find
the descriptions of the individual projects on our CSG-COUSIN homepage or follow the link by
[CTRL+]click on the specific name in the table.
CURRENT CSG-COUSIN COS PROJECT GROUPS
Acne vulgaris (ACORN)
Atopic Eczema (HOME)
Chronic Spontaneous Urticaria
Chronic wounds
Hidradenitis suppurativa
Incontinence-Associated Dermatitis
Melanoma
Nail psoriasis
Pressure Ulcer Trials (OUTPUTs)
Rosacea
Vascular malformations (OVAMA)
Vitiligo
Appearance of Facial Aging (IMPROVED)
Hand Eczema
If you are interested in the development of COS or in systematic reviews in the field of dermatology,
or in the work of CSG-COUSIN generally, just get in contact: [email protected]
CSG-COUSIN COS PROJECT GROUPS AND CSG-COUSIN METHODS GROUP
CSG-COUSIN project groups work on the development and implementation of specific COS in
dermatology. Project groups consist of international members representing different stakeholder
groups e.g. patient representatives or dermatologists. Every CSG-COUSIN project group is supported
by a methodologist with experiences in COS development with methodological support and internal
peer review. Beside the support for the project groups the methods group conducts own
methodological studies on outcomes research and COS development (find the current protocol:
here). Further the methods group contributes to develop methodological standards based on the
HOME roadmap. In February they published a guidance on how to develop a core outcome set for
skin disease for the project groups - click to find the entire guidance here!
Guidance on how to develop a COS for skin disease by the CSG-COUSIN methods group
Summary: The CSG-COUSIN recommends using the Harmonising Outcome Measures for Eczema
(HOME) roadmap1 to structure the core outcome set (COS) development process (or parts of it). The
HOME roadmap provides guidance how to define, select and recommend the most important core
outcome domains and how to identify the best measurement instruments for these identified
domains. Despite the existence of guidance on how to develop COS2, many details are unclear3. For
instance, there is no ‘gold’ standard on how to do consensus studies (e.g. which decision rules to
use) and how to select/develop core outcome domains and outcome measurement instruments4.
This document is intended to provide guidance and essential references in order to ensure that a
new COS is developed with an appropriate high quality methodological level. Among others, we
strongly recommend developing a protocol a priori for the COS development framework.
Inappropriately developed and published COS are potentially worse than no COS if they end up
measuring the wrong things in the wrong way. Formal guidelines for outcome measurement
selection and for reporting for COS development studies are under development5-6 and a handbook
by the Core Outcome Measures in Effectiveness Trials (COMET) initiative is expected in 2016.
Click here for the entire guidance!
1
Schmitt J, Apfelbacher C, Spuls PI, et al. The Harmonizing Outcome Measures for Eczema (HOME) roadmap:
a methodological framework to develop core sets of outcome measurements in dermatology. J Invest
Dermatol. 2015;135(1):24-30.
2
Boers M, Kirwan, JR, Tugwell P. The OMERACT Handbook. 2015.
http://www.omeract.org/pdf/OMERACT_Handbook.pdf
3
Gargon E, Young B, Williamson PR. A Mixed Methods Study of Researchers' Experiences of Developing Core
Outcome Sets. Value Health. 2015;18(7):A724.
4
Kirwan JR, Boers M, Hewlett S et al. Updating the OMERACT filter: core areas as a basis for defining core
outcome sets. J Rheumatol. 2014;41(5):994-9.
5
Kirkham JJ, Gorst S, Altman DG et al. COS-STAR: a reporting guideline for studies developing core outcome
sets (protocol). Trials. 2015;16:373.
6
Prinsen CA, Vohra S, Rose MR, et al. Core Outcome Measures in Effectiveness Trials (COMET) initiative:
protocol for an international Delphi study to achieve consensus on how to select outcome measurement
instruments for outcomes included in a 'core outcome set'. Trials. 2014;15:247.
PRESENTATION OF ONE CSG-COUSIN COS PROJECT GROUP:
The Outcomes for Pressure Ulcer Trials (OUTPUTs) project: Development of a core outcome set
for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention
interventions
Pressure ulcers (PUs) are chronic wounds associated with poor mobility and co-morbid diseases.
They are considered preventable but existing evidence regarding the efficacy of preventative
interventions is inconclusive. There are concerns about the relevance, validity and reliability of
outcome measures used in PU prevention trials. In the past, this had led to a distinct heterogeneity
across existing trials, hampering meaningful synthesis of trial findings and knowledge translation
into clinical practice.
To address this limitation, the OUTPUTs (OUTcomes for Pressure Ulcer Trials) project was set up by
an international team of PU prevention researchers1 to develop a core outcome set (COS) for trials
evaluating the efficacy or effectiveness of PU prevention interventions. This set will comprise two
interrelated components: a Core Domain Set reflecting the prioritised outcome areas, and a Core
Measurement Set comprising instruments for the measurement of the core domains.
Following existing methodological frameworks2,3, the project comprises four steps: (1) Scope
definition, (2) Consensus-building on the Core Domain Set, (3) Consensus-building on the Core
Measurement Set, and (4) Dissemination and implementation. A detailed outline can be found here.
In steps 2 and 3, rigorous methods will be used to synthesise existing research evidence and to
reach consensus among the stakeholder groups regarding outcome domains and measurement
instruments. Furthermore, given the challenges of involving patients at risk of PU development in
research, innovative approaches will be applied to ensure that service user views are integrated into
the COS. This will be facilitated by close collaboration with existing PU service user groups such as
the Pressure Ulcer Research Service User Network UK (PURSUN UK).
The 24-month project started in January 2016. Step 1 is complete, and a scoping review of the
outcomes used in existing trials is underway. This review will be followed by structured discussions
with service users on relevant outcome domains and a Delphi study addressing all relevant
stakeholder groups, e.g. clinical experts, clinical researchers, and service users
In particular with regard to the service user involvement throughout the project and the Delphi
study for the consensus-building of the Core Domain Set, the project team welcomes any interest in
the OUTPUTs project and is keen to share methodological experiences.
Contact: Prof. Dr. Katrin Balzer - Email: [email protected]
1
Balzer K, Coleman S, Muir D, Kottner J, Nixon J. OUTPUTs. The Outcomes for Pressure Ulcer Trials (OUTPUTs)
project. https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-theteams/project-groups/the-outcomes-for-pressure-ulcer-trials-outputs-project, accessed 19.05.2016.
2
Cochrane Skin Group – Core Outcome Set Initiative (CSG-COUSIN): Guidance on how to develop a core
outcome set for skin disease (https://www.uniklinikum-dresden.de/de/dasklinikum/universitaetscentren/zegv/cousin/cos-development-guidance-is-online), accessed 05.04.2016.
3
Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Tugwell P. Developing core outcome
sets for clinical trials: issues to consider. Trials 2012, 13:132.
Recommendation: COMET VI Meeting
The COMET Initiative will hold its sixth meeting in Amsterdam on
10th to 11th November 2016. They will bring together individuals
interested in the development and application of “core outcome sets”
in many different areas of health care. There is no registration fee for
the meeting, and lunch and refreshments will be provided free of charge.
The number of spaces is limited, which may mean that they have to close registration some time in
advance of the meeting. They therefore encourage early registration to avoid disappointment.
http://www.comet-initiative.org/meeting
To view the programme, click here
To register, click here
Call for Abstracts: We highly recommend the COMET Meeting to all CSG-COUSIN members and
advise the project groups to submit an abstract about their COS-project (deadline: 19th August).
Please ask for the CSG-COUSIN logo and feel free to get in contact:
[email protected]
Save the date: CSG-COUSIN Meeting 2017
The second CSG-COUSIN Meeting will take place
together with the Annual Cochrane Skin Group
Meeting 2017 on the 9th and 10th January 2017
in Berlin, Charité-Universitätsmedizin, Germany.
The first day topics to CSG-COUSIN will be presented and we are planning presentations of all
CSG-COUSIN COS project groups with room for exchange and talk about the experiences.
The scope on the second day is to present wider Cochrane Skin Group issues.
Please save the date: 9th - 10th January 2017 in Berlin
Detailed information will be followed on our CSG-COUSIN homepage:
https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meetings
Please follow this link to the published Meeting-Report from the inaugural Meeting 2015:
Report from the kick-off meeting of the Cochrane skin group core outcome set initiative