The MoleMate™ UK Trial: The management of suspicious pigmented lesions in primary care

Conditions

Pigmented lesions/ diagnosis of melanoma Skin and Connective Tissue Diseases Pigmented lesions/ diagnosis of melanoma

Wilson EC, Emery JD, Kinmonth AL, Prevost AT, Morris HC, Humphrys E, Hall PN, Burrows N, Bradshaw L, Walls J, Norris P, Johnson M, Walter FM.

2013-03-0115 citations

10.1016/j.jval.2012.12.008

Effect of adding a diagnostic aid to best practice to manage suspicious pigmented lesions in primary care: randomised controlled trial.

Walter FM, Morris HC, Humphrys E, Hall PN, Prevost AT, Burrows N, Bradshaw L, Wilson EC, Norris P, Walls J, Johnson M, Kinmonth AL, Emery JD.

2012-07-0441 citations

10.1136/bmj.e4110

Patient understanding of moles and skin cancer, and factors influencing presentation in primary care: a qualitative study.

Walter FM, Humphrys E, Tso S, Johnson M, Cohn S.

2010-08-3119 citations

10.1186/1471-2296-11-62

Interventions

The study aims to recruit 1,800 participants from 15 general practices (intervention group 900

control group 900) over a trial period of 16 months per practice. Patients who are eligible and agree to participate will be randomised to either the control group, where the lesion w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 years or over 2. Attending a GP or practice nurse appointment at a study general practice 3. The patient or practitioner describes a pigmented lesion, although the lesion need not be the presenting symptom

Exclusion criteria

Exclusion criteria: 1. Patients with a pigmented lesion which is immediately diagnosed as benign and the patient reassured 2. Patients who do not give their consent or are not able to understand the consent process 3. Patients felt unsuitable by their GP due to other on-going physical or psychological conditions such as cognitive impairment, serious illness

Design outcomes

Primary

Measure	Time frame
The proportion of referred pigmented lesions that are monitored or biopsied from the intervention group compared with the proportion of referred pigmented lesions that are monitored or biopsied from the control group. This will reflect the extent to which use of the MoleMate system in primary care increases the diagnostic accuracy and appropriateness of referrals to secondary care.	—

Secondary

Measure	Time frame
1. Assessment of participant satisfaction and anxiety at one week and three months after the consultation in general practice 2. Comparison of the diagnostic performance of clinicians with the MoleMate system and without 3. Assessment of clinician learning when using the MoleMate system 4. Assessment of clinician confidence in the MoleMate system 5. Examination of the association between the 'Index of Suspicion' scale and the seven-point checklist, and their predictiveness of lesion outcomes 6. Economic analysis of using the MoleMate system in primary care 7. Creation of a cohort of participants from the trial who will have melanoma-specific diagnosis and mortality over 5-years survival outcomes assessed	—

Measure

Time frame

1. Assessment of participant satisfaction and anxiety at one week and three months after the consultation in general practice 2. Comparison of the diagnostic performance of clinicians with the MoleMate system and without 3. Assessment of clinician learning when using the MoleMate system 4. Assessment of clinician confidence in the MoleMate system 5. Examination of the association between the 'Index of Suspicion' scale and the seven-point checklist, and their predictiveness of lesion outcomes 6. Economic analysis of using the MoleMate system in primary care 7. Creation of a cohort of participants from the trial who will have melanoma-specific diagnosis and mortality over 5-years survival outcomes assessed

—

Countries

England, United Kingdom

Outcome results

None listed