Evidence map›Paper›PMID 28764734›Full record

ArticleTrials2017

Development of a core outcome set for clinical trials in facial aging: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

Daniel I Schlessinger, Sanjana Iyengar, Arianna F Yanes, Jill K Henley, Hovik J Ashchyan, Anastasia O Kurta, Payal M Patel, Umar A Sheikh, Matthew J Franklin, Courtney C Hanna and 10 more

Abstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Daniel I SchlessingerDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 North St. Clair Street, Suite 1600, Chicago, IL, USA.
Sanjana IyengarDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 North St. Clair Street, Suite 1600, Chicago, IL, USA.
Arianna F YanesDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 North St. Clair Street, Suite 1600, Chicago, IL, USA.
Jill K HenleyDepartment of Dermatology, University of Pennsylvania, Philadelphia, PA, USA.
Hovik J AshchyanDepartment of Dermatology, University of Pennsylvania, Philadelphia, PA, USA.
Anastasia O KurtaDepartment of Dermatology, St. Louis University School of Medicine, St. Louis, MO, USA.
Payal M PatelDepartment of Dermatology, St. Louis University School of Medicine, St. Louis, MO, USA.
Umar A SheikhDepartment of Dermatology, St. Louis University School of Medicine, St. Louis, MO, USA.
Matthew J FranklinDepartment of Dermatology, Penn State Hershey Dermatology, Hershey, PA, USA.
Courtney C HannaDepartment of Dermatology, Penn State Hershey Dermatology, Hershey, PA, USA.
Brian R ChenDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 North St. Clair Street, Suite 1600, Chicago, IL, USA.
Sarah G ChirenDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 North St. Clair Street, Suite 1600, Chicago, IL, USA.
Jochen SchmittCentre for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany.
Stefanie DeckertCentre for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany.
Karina C FurlanDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 North St. Clair Street, Suite 1600, Chicago, IL, USA.
Emily PoonDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 North St. Clair Street, Suite 1600, Chicago, IL, USA.
Ian A MaherDepartment of Dermatology, St. Louis University School of Medicine, St. Louis, MO, USA.
Todd V CarteeDepartment of Dermatology, Penn State Hershey Dermatology, Hershey, PA, USA.
Joseph F SobankoDepartment of Dermatology, University of Pennsylvania, Philadelphia, PA, USA.
Murad AlamDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 North St. Clair Street, Suite 1600, Chicago, IL, USA. m-alam@northwestern.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFacial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick skin type may be associated with the rate and type of facial aging. Although many clinical trials assess the correlates of skin aging, there is heterogeneity in the outcomes assessed, which limits the quality of evaluation and comparison of treatment modalities. To address the inconsistency in outcomes, in this project we will develop a core set of outcomes that are to be evaluated in all clinical trials relevant to facial aging. METHODS/

designA long list of measureable outcomes will be created from four sources: (1) systematic medical literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Two rounds of Delphi processes with homogeneous groups of physicians and patients will be performed to prioritize and condense the list. At a consensus meeting attended by physicians, patients, and stakeholders, outcomes will be further condensed on the basis of participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. Subsequent to this, specific measures will be selected or created to assess these outcomes. DISCUSSION: The aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging. We hope to improve the reliability and consistency of outcome reporting of skin aging, thereby enabling improved evaluation of treatment efficacy and patient satisfaction.

trial registrationCore Outcome Measures in Effectiveness Trials (COMET) Initiative, accessible at http://www.comet-initiative.org/studies/details/737 . Core Outcomes Set Initiative, (CSG-COUSIN) accessible at https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-the-teams/project-groups/core-outcome-set-for-the-appearance-of-facial-aging . Protocol version date is 28 July 2016.

Indexed as

Clinical Trials as TopicCosmetic TechniquesDelphi TechniqueEndpoint DeterminationFaceRejuvenationSkin AgingAge FactorsConsensusHumansPatient Outcome AssessmentResearch DesignStakeholder ParticipationSystematic Reviews as TopicTreatment OutcomeAgingConsensusCore outcome setDelphiStakeholdersSystematic review

Identifiers

PMID28764734
PMCPMC5540562

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.