Clinical scoring tool for AN of equal use to clinicians and the public
Research type
Research Study
Full title
Establishing an effective clinical scoring tool for the severity of Acanthosis Nigricans of the skin that is of equal use to clinicians and the public
IRAS ID
273956
Contact name
Niamh Callanan
Contact email
Sponsor organisation
Sheffield Children's Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 7 months, 19 days
Research summary
Acanthosis Nigricans (AN) is a dark brown velvety discolouration of the skin typically on the back of the neck and in the axilla. It is thought to be caused by high levels of insulin and is strongly associated with Type 2 Diabetes and with obesity. Those individuals with AN have almost double the risk of Type 2 Diabetes compared to those who do not.
Acanthosis is therefore a highly visible risk marker for Type 2 Diabetes. As such it may be an appropriate area in which to consider whether a public health campaign or self-assessment tool may help identify previously undetected cases of Type 2 Diabetes and identify individuals at higher risk of Type 2 Diabetes in whom interventions may prevent progression to Diabetes.
The severity scoring tool has potential to be used as a public health campaign and so it is important that the scale is equally accessible to clinicians and lay people. This study part intends to assess the reliability of three potential scales to establish which is most effective in reliably scoring the severity of AN.
Participants will consist of child participants aged 11-18 years of age with AN, the parental guardians of the child participant, and practicing clinicians/medical students. Participants will be divided via stratified sampling to ensure an equal distribution of participant representation throughout the groups. Each group will use one of the three potential scales to score ten photographs of AN. Interobserver and intraobserver reliability will be calculated from participant responses, and statistical analysis will then take place in order to to establish which scoring scale is most reliable.
The intervention will take place at Sheffield Children's Hospital or in the participants' home. The single intervention required in this study part should last no longer than 30 minutes.REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0052
Date of REC Opinion
4 Feb 2020
REC opinion
Further Information Favourable Opinion