Sample Application

1. Disease State:
Hidradenitis suppurativa

2. Section Aims:
To achieve international stakeholder consensus on a core set of domains for interventional trials
To evaluate existing measures for each of the domains in the core set
To develop measures for the core domain set as required
To achieve international stakeholder consensus on a core outcome set for interventional trials

3. Background and Previous Work:
Randomised Controlled Trials should have well-defined primary and secondary outcomes to answer questions generated by the main hypotheses. However, reported outcome measures in hidradenitis suppurativa (HS) are numerous and diverse. A recent systematic review found a total of 30 outcome measure instruments in 12 RCTs. This use of a broad range of outcome measures can increase difficulties in interpretation and comparison of results, and may potentially obstruct appropriate evidence synthesis by causing reporting bias. One strategy for dealing with these problems is to develop a Core Outcome Set (COS). A COS is a list of outcomes that are meant as mandatory and should be measured and reported in all clinical trials. The aim of this study is to develop a COS for the management of HS.

To our knowledge, this is a unique project with limited prior work. 

4. Section Members:
HS will form a section under IDEOM known as HISTORIC (HIdradenitis SuppraTiva cORe outcomes set International Collaboration: a multinational partnership among IDEOM, Cochrane Skin Group, and Zealand University Hospital Roskilde)

HISTORIC will have a steering committee comprised of Gregor Jemec, John Ingram, Linnea Thorlacius, Bente Villumsen (patient research partner) and Amit Garg (section lead).

5. Support:
Initial support is request for the following:

• Weekly conference line
• Administration of an e-Delphi exercise for core domains
• Attendance of the steering committee and 15 section members at the annual IDEOM meeting for 2 years.

We will apply for grants and/or sponsorships upon formation of the section. IDOEM shall hold grants in sponsorships specified for use by the HS section.

 

Items to Note in Acceptance Letter
All workgroups should report on their work at the Annual meeting
IDEOM will manage revenues and expenses for the section under its 501c3
IDEOM should be formally acknowledged on all publications
The section should provide quarterly report of progress to the Board

1. Disease State: what is the dermatologic condition on which this proposal is based?

2. Section Aims: please list overarching objectives of the proposed project.

3. Background and Previous Work:

• Please briefly describe the rationale/need for evaluation or development of disease measures or outcomes in the proposed disease state
• Please briefly describe work already achieved in the proposed area, if any

4. Section Members:

• Please describe the governance of the proposed section. Who is the proposed section leader? Is there a steering committee? How will you engage patient partners in the proposed project?
• Please list the initial membership roster, with consideration of the support proposed

5. Support:

• Please describe support required from IDEOM and for period of time requested (i.e., Delphi exercises; in-person inter-rater reliability study; attendance of 15 members at one in-person meeting per year for 3 years)
• Please describe existing or potential funding or sponsorship sources which may be available