Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines

NCT ID: NCT05144165

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-08

Study Completion Date

2022-03-31

Brief Summary

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French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults have been developed by the psoriasis research group of the French Society of Dermatology using literature available until July 2017 (Amatore et al, 2019). Because several systemic treatments have been marketed since then, new guidelines are mandatory. The aim of this study coordinated by the Centre of Evidence of the French Society of Dermatology is to update the available French guidelines using a Delphi method.

Detailed Description

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Justification of Delphi methodology

The Delphi method has been widely used for elaboration of guidelines. The goal of the Delphi method is to solicit group opinion and to combine the opinion of a panel of experts into a consensus (or dissensus). During a Delphi study, multiple rounds of questionnaires are sent to a panel of experts with feedback between rounds, allowing experts to re-evaluate their responses along with the replies of other experts.

Design, expert eligibility and data collection A steering committee of members of the French Centre of Evidence (G. Chaby, F. Corgibet, L. Fardet, S. Leducq, F. Poizeau https://reco.sfdermato.org/fr/centre-de-preuves-en-dermatologie) and members of the Psoriasis Research Group of the French Society of Dermatology (M. Chastagner, L. Gouillon), without any competing interest regarding this topic, will be in charge with elaboration and conduction of the Delphi study.

The selected experts will be asked whether they agree to participate in the Delphi survey. Upon acceptance, they will be asked to answer the Delphi study administered using the online survey Welphi®. Before the first round, demographic information (age, sex, location of practice, availability of a phototherapy cabin, public or private practice) and competing interests will be collected. All experts will provide informed consent. Experts will have 2 weeks to complete the online survey with two email reminders. For each round, the number of experts who completed the surveys will be documented.

Procedure

Definition of consensus For statements with responses on an ordinal 7-point Likert scale (rating 1, strongly disagree to 7 strongly agree), 'agreement' will be defined as a score of 5-7, 'neutral' by a score of 4 and 'disagreement' by a score of 1-3. Consensus will be defined as achieved when \> 70% experts will vote for a given option on the Likert scale. For Multiple Choice Questions (MCQs), consensus will be defined as achieved if \> 70% experts voted for a particular option. Median and interquartile range (IQR) will be used to describe the central tendency and dispersion of responses: a "strong statement" will be defined as a median score of ≥ 6 or ≤ 2 on the Likert scale and 90% votes for MCQs. If consensus is not reached for one question (using Likert scale or MCQ) after 3 rounds, dissensus is acted. For this study, four rounds are planned, including round 1 with open-ended questions (see below) and a maximum of three rounds to obtain consensus.

Conditions

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Psoriasis Psoriasis Palmaris Psoriasis Inverse Psoriasis Vulgaris Psoriatic Nail Psoriatic Plaque Psoriasis Guttate Psoriasis of Scalp Psoriasis Universalis Psoriatic Erythroderma Psoriasis Pustular

Keywords

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Delphi Consensus statement Guidelines Experts

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Experts consensus

Consensus opinion using Delphi Methodology

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* French dermatologists
* public and private practice practitioners
* members of the French Society of Dermatology
* expertise in the field of psoriasis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre of Evidence of the French Society of Dermatology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center of Evidence of Dermatology

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier CHOSIDOW, MD, PhD

Role: CONTACT

Email: [email protected]

Sophie LEDUCQ, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Olivier Chosidow, MD, PhD

Role: primary

Sophie Leducq, MD

Role: backup

References

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Amatore F, Villani AP, Tauber M, Viguier M, Guillot B; Psoriasis Research Group of the French Society of Dermatology (Groupe de Recherche sur le Psoriasis de la Societe Francaise de Dermatologie). French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):464-483. doi: 10.1111/jdv.15340. Epub 2019 Feb 22.

Reference Type RESULT
PMID: 30793796 (View on PubMed)

Related Links

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https://centredepreuves.sfdermato.org

French Centre of Evidence in Dermatology

Other Identifiers

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CDPDelphiPso

Identifier Type: -

Identifier Source: org_study_id