- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05144165
Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines
Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines Using Delphi Consensus Statement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Olivier Chosidow, MD, PhD
- Email: olivier.chosidow@aphp.fr
Study Contact Backup
- Name: Sophie Leducq, MD
- Email: sophie.leducq@univ-tours.fr
Study Locations
-
-
-
Paris, France, 75009
- Recruiting
- Center of Evidence of Dermatology
-
Contact:
- Olivier Chosidow, MD, PhD
- Email: olivier.chosidow@aphp.fr
-
Contact:
- Sophie Leducq, MD
- Email: sophie.leducq@univ-tours.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria
- French dermatologists
- public and private practice practitioners
- members of the French Society of Dermatology
- expertise in the field of psoriasis
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Update of the French guidelines by consensus using participating experts opinions
Time Frame: 15 days to complete the online survey for each round
|
Round 1 will include
Round 2, 3 and 4 Experts will be asked to review the questionnaire based on the information provided in the former round. They will have to re-rate the 12 questions using the 7-point Likert scales. Regarding special indications for each therapeutic agent, expert's comments from round 1 will be synthesized and converted into MCQs for subsequent rounds. If consensus is reached for one question, the question will not reappear in subsequent rounds. |
15 days to complete the online survey for each round
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDPDelphiPso
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis
-
ProgenaBiomeRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Face | Psoriasis Nail | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaUnited States
-
Clin4allRecruitingPsoriasis of Scalp | Psoriasis Nail | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrance
-
Innovaderm Research Inc.CompletedScalp Psoriasis | Pustular Palmo-plantar Psoriasis | Non-pustular Palmo-plantar Psoriasis | Elbow Psoriasis | Lower Leg PsoriasisCanada
-
UCB Biopharma S.P.R.L.CompletedModerate to Severe Psoriasis | Generalized Pustular Psoriasis and Erythrodermic PsoriasisJapan
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
-
TakedaRecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Janssen Pharmaceutical K.K.RecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Eli Lilly and CompanyCompletedGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Shanghai Huaota Biopharmaceutical Co., Ltd.RecruitingGeneralized Pustular Psoriasis (GPP)China
-
Herlev and Gentofte HospitalRecruitingMyocardial Infarction | Myocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Heart Failure | Stroke | Psoriasis | Heart Failure, Diastolic | Psoriasis Vulgaris | Cardiovascular Risk Factor | Heart Failure, Systolic | Left Ventricular Dysfunction | Psoriasis Universalis | Psoriasis Face | Psoriasis Diffusa | Psoriasis... and other conditionsDenmark
Clinical Trials on Experts consensus
-
NMC Specialty HospitalCompletedCovid19 | Acute Respiratory Distress Syndrome | Acute Respiratory FailureUnited Arab Emirates
-
Prashant NasaCompletedRespiratory Failure | Respiratory Distress Syndrome | Right Ventricular Dysfunction | Extracorporeal Membrane Oxygenation Complication | Extracorporeal Circulation; Complications | Right Heart FailureUnited Arab Emirates
-
Prashant NasaWorld Federation of Societies of AnaesthesiologistsCompletedTraining | Education | CompetenceIndia
-
Evidation HealthOne DropCompletedType 2 Diabetes MellitusUnited States
-
Sun Yat-sen UniversityCompleted
-
Charite University, Berlin, GermanyCompleted
-
University of MiamiConsensus OrthopedicsActive, not recruitingOsteoarthritis, Knee | Arthroplasty, Replacement, KneeUnited States
-
University of SouthamptonEnrolling by invitationPostoperative Complications | Rectal Cancer | Pelvic Cancer | Pelvic Neoplasm | Pelvic Exenteration | Empty Pelvis SyndromeUnited Kingdom
-
Chandra Osborn, PhD, MPHUnknownDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type 1 | PreDiabetesUnited States
-
Kanuni Sultan Suleyman Training and Research HospitalCompleted