Core Outcome Set for the Appearance of Facial Aging

While aging is not a disease, it is treated as a condition in the context of efforts to treat aging by interventions like cosmetics, cosmeceuticals, minimally invasive cosmetic procedures, laser and energy procedures, and invasive cosmetic surgery, among others. There is hence a need for a core outcome set for measurement of baseline, diagnosis, and changes associated with interventions. Relevant domains appear to include the visible signs of chronological and photoaging, body image effects, and social impact. Patient reported outcomes are highly relevant.

Contributors

Improved Measurement of Priority Outcome VariablEs in Dermatology and Surgery

Steering Group (IMPROVED):
Murad Alam, MD (Northwestern University)
Ian A. Maher, MD (Saint Louis University)
Joseph F. Sobanko, MD (University of Pennsylvania)
Todd V. Cartee, (Penn State University)


Members (IMPROVED):
Adam M. Rotunda, MD
Christian L. Baum, MD (Mayo Clinic)
Jeremy S. Bordeaux (Case Western Reserve University)
Daniel B. Eisen, MD (University of California at Irivine)
Emmy M. Graber, MD (Boston University)
Erica H. Lee, MD (Memorial Sloan-Kettering Cancer Center)
Isaac M. Neuhaus, MD (University of California at San Francisco)
Jeremy B. Green, MD
Justin J. Leitenberger, MD (Oregon Health Sciences University)
Keyvan Nouri, MD (University of Miami)
Kira Minkis, MD (Cornell University)
Mathew M. Avram, MD (Harvard University)
Michel McDonald, MD (Vanderbilt University)
Nathan S. Uebelhoer, DO
S. Brian Jiang, MD (University of California at San Diego)
Siegrid S. Yu, MD (University of California at San Francisco)
Thuzar M. Shin, MD, PhD (University of Pennsylvania)
Zakia Rahman, MD (Stanford University)

Data Team:
Daniel I. Schlessinger
Sanjana Iygengar
Arianna F. Yanes
Jill K. Henley
Hovik J. Ashchyan
Anastasia O. Kurta
Payal M. Patel
Umar A. Sheikh
Matthew J. Franklin
Courtney C. Hanna
Brian R. Chen
Sarah G. Chiren
Karina C. Furlan
Emily Poon

Further Study Information

Current Stage: Ongoing
Date: March 2013 - October 2020
Funding source(s): Northwestern University Dermatology Department Research Funds Dermatology Foundation Grant to Dr. Sobanko St. Louis University Department of Dermatology Research Funds


Health Area

Disease Category: Other, Skin

Disease Name: N/A

Target Population

Age Range: 18 - 90

Sex: Either

Nature of Intervention: Drug, Surgery

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Epidemiologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Regulatory agency representatives

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus conference
- Consensus meeting
- Delphi process
- Interview
- Systematic review

Initial consensus meeting to develop working group and idea. (March 2013)

Second consensus meeting to refine topic and develop plan, which follows.

A systematic review to extract relevant outcomes via an outcomes grid followed by generation of additional items from NGT with clinicians and interviews/focus groups with patients. Additional outcomes elicited from surveys of regulators (US FDA), industry representatives, and representatives patient groups/members of key social media websites.

Reconciliation of items, and elimination of duplicates.

Separate Delphi processes x 2 involving patients and clinicians, respectively.
Additional similar process involving international (non-US) patients and clinicians, respectively.

Consensus conference at which multiple stakeholder groups are present to validate results, and possibly initiate additional reconciliation process, if necessary.

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