Condition category
Skin and Connective Tissue Diseases
Date applied
24/10/2017
Date assigned
07/11/2017
Last edited
03/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Psoriasis is a skin condition that can cause red, flaky patches on any part of the body including the face, scalp, hands and genitals. Children and young people with psoriasis can develop an inflammatory arthritis leading to swelling, discomfort and permanent joint damage. Psoriasis may also lead to obesity and long-term health problems such as high blood pressure and diabetes. It is therefore important that psoriasis is diagnosed accurately and early, so that specific treatment and monitoring can be started. Psoriasis is often difficult to diagnose in children and young people. Research shows that up to nine in ten children with psoriasis are mistakenly diagnosed with other skin conditions by non-dermatologists. A group of experts in psoriasis from around the world have agreed a list of diagnostic criteria that are important for the diagnosis of psoriasis in children/young people. In this study, the agreed diagnostic criteria are tested in children/young people with psoriasis and children/young people with other skin conditions. This study assesses how well the criteria separate these two groups. The results are used to improve the diagnostic criteria by removing those that poorly predicted psoriasis.

Who can participate?
Children/young people, aged 0 to 18 with possible or confirmed psoriasis or a scaly inflammatory rash

What does the study involve?
Participants attend for one study visit lasting about 30 minutes. All participants undergo an assessment based on the 16 items agreed as important for the diagnosis of children and young people. The assessment includes a physical examination and clinical questioning. Demographic information and quality of life data are also collected. The assessment is undertaken by a trained research nurse or study investigator and the assessor, where possible, is unaware of the child’s/young person’s diagnosis. The first 40 participants recruited are assessed by two different assessors one after the other to test the variability of the diagnostic criteria. Additional information are collected from participants' medical records, including the confirmed dermatologist’s diagnosis, disease severity, duration of disease, and current skin medications.

What are the possible benefits and risks of participating?
The study does not involve any tests or medications, and will hopefully help children and young people to be diagnosed with psoriasis earlier and more accurately in the future. Participants in the study will have their skin closely looked at, including more private body areas such as the groin and bottom. The study does not change their individual medical treatment and will not improve their skin disease.

Where is the study run from?
The study takes place at children’s’ dermatology departments across the UK and is led from the University of Nottingham (UK)

When is the study starting and how long is it expected to run for?
August 2016 to August 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Esther Burden-Teh
dipsoc@nottingham.ac.uk

Trial website

http://www.nottingham.ac.uk/research/groups/cebd/projects/5rareandother/dipsoc.aspx

Contact information

Type

Scientific

Primary contact

Dr Esther Burden-Teh

ORCID ID

http://orcid.org/0000-0002-0033-2836

Contact details

Centre of Evidence Based Dermatology
Kings Meadow Campus
University of Nottingham
Nottingham
NG7 2NR
United Kingdom
+44 (0)115 84 68633
dipsoc@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

220116

Study information

Scientific title

Developing diagnostic criteria for psoriasis in children and young people: a multi-centre case control study in paediatric dermatology clinics

Acronym

DIPSOC

Study hypothesis

The best predictive diagnostic criteria can be developed from the consensus agreed diagnostic criteria using a multivariate model and will achieve a sensitivity and specificity of >70% with the fewest number of essential items.

The benefit of developing diagnostic criteria for psoriasis in children will be to improve diagnosis by non-dermatologists such as GPs and paediatric rheumatologists. This will ensure children are referred to secondary care, receive psoriasis specific treatment and undergo monitoring for associated diseases (eg juvenile psoriatic arthritis) as per national guidelines (NICE 2012). Diagnostic criteria will also standardise disease definitions in studies; improving quality and permitting meta-analysis. This study will also investigate the performance of the diagnostic criteria in indeterminate psoriasis; providing preliminary information on whether the diagnostic criteria can help predict psoriasis in those with possible psoriasis.

Ethics approval

East Midlands - Nottingham 2 Research Ethics Committee, 03/02/2017, ref: 17/EM/0035

Study design

Multi-centre case-control diagnostic accuracy study with a nested sub-study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

http://www.nottingham.ac.uk/research/groups/cebd/projects/5rareandother/dipsoc.aspx

Condition

Psoriasis in children and young people

Intervention

All participants to undergo a diagnostic criteria assessment based on the 16 diagnostic items that the consensus study agreed as important for the diagnosis of children and young people. The assessment includes a physical examination and clinical questioning. Demographic information and quality of life data will also be collected. The assessment will be undertaken by a trained research nurse or study investigator and the assessor, where possible, will be unaware of the child’s/young person’s diagnosis. The first 40 participants recruited will be assessed by two different assessors consecutively to enable inter-observer variability of the diagnostic criteria to be evaluated. Additional information will be collected from the medical record. These data will include the confirmed dermatologist’s diagnosis (reference standard), disease severity, duration of disease, and current skin medications.

Intervention type

Phase

Drug names

Primary outcome measure

Consensus agreed diagnostic criteria vs reference standard (dermatologist’s diagnosis). The presence or absence (binary) of each of the diagnostic criterion will be assessed by study investigators trained to undertake the diagnostic criteria assessment and blinded to the diagnosis of the participant. The threshold for diagnosis according to the consensus agreed diagnostic criteria has been determined through the consensus study. The diagnostic accuracy of the consensus agreed diagnostic criteria will be assessed using sensitivity and specificity. The best predictive diagnostic criteria will be developed using multivariate analysis and the decision to include individual criteria in the model will be based on the likelihood ratio.

Secondary outcome measures

1. The diagnostic performance of the consensus agreed diagnostic criteria and the best predictive criteria for plaque psoriasis (measured as per the primary objective); these criteria will be graphically presented and compared on Receiver Operator Characteristic (ROC) curves
2. The inter-observer variability in the diagnostic criteria assessment; two study investigators will independently undertake the diagnostic criteria assessment. The variability between the investigators will be assessed using the Kappa statistic
3. The variability in the reference standard for psoriasis; a sample of clinical images of participants with psoriasis (taken as part of routine practice) will be anonymised and circulated amongst clinical principal investigators. The variability in principal investigators’ opinions on the diagnosis of psoriasis will be assessed using the Kappa statistic
4. The performance of the best predictive diagnostic criteria in identifying children/young people with psoriasis currently diagnosed with indeterminate disease (nested sub-study); a questionnaire will be sent 24 months after the end of the study asking about their current skin disease. The best predictive criteria vs participant reported diagnosis from the questionnaire. The performance of the best predictive criteria will be assessed using sensitivity and specificity

Overall trial start date

09/08/2016

Overall trial end date

31/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Cases:
1. Children/young people (0 to <18 years of age)
2. Confirmed diagnosis of plaque psoriasis by a dermatologist
3. Active disease at the time of assessment
4. Able to consent

Controls:
1. Children/young people (0 to <18 years of age)
2. Confirmed diagnosis of a scaly inflammatory rash (excluding psoriasis and indeterminate psoriasis) by a dermatologist
3. Active disease at the time of assessment
4. Able to consent

Indeterminate psoriasis:
1. Children/young people (0 to <18 years of age)
2. Diagnosis of indeterminate or possible psoriasis by a dermatologist
3. Active disease at the time of assessment
4. Able to consent and willing to receive a follow-up questionnaire after 24 months

Participant type

Mixed

Age group

Child

Gender

Both

Target number of participants

160 cases, 160 controls, convenience sample of indeterminate psoriasis

Participant exclusion criteria

1. Children/young people with pustular psoriasis
2. Children/young people with erythrodermic psoriasis
3. Children/young people without a dermatologist’s diagnosis

Recruitment start date

25/10/2017

Recruitment end date

31/08/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Queens Medical Centre Derby Road Nottingham
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

Research and Graduate Services
King’s Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
+44 (0)115 846 7906
sponsor@nottingham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Additional documents will be available online at http://www.nottingham.ac.uk/research/groups/cebd/projects/5rareandother/dipsoc.aspx. The protocol and participant information sheets have already been made available on this website.

The study results will be disseminated in clinical and academic forums, through scientific publication and presentation. Results will also be shared through the study website, updated on the Centre of Evidence Based Dermatology website and participant newsletter. The trialists intend to publish approximately one year after the end of the study (August 2020).

IPD sharing statement
Anonymised participant level data will be made available on request. The data will be held at the University of Nottingham.

Intention to publish date

01/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes