Original Title: Dermatoscopia Digital

Authors' objectives: Dermatoscopy requires minimal training and can be carried out using a manual dermatoscope (MD) or a digital dermatoscope (DD). The latter offers a higher magnification of the structures to be viewed and provides images that can be compared with each other during patient monitoring and even whole-body photographs of the person. The aim of this report is to analyse the diagnostic capacity of DD compared to MD or with the combined use of both for the diagnosis of CM and its influence on subsequent clinical decision-making and patient health results, its efficiency and/or differences in the use of resources and costs, as well as to inform the population’s experiences of a possible diagnosis of CM and the need to monitor their lesions.

Authors' results and conclusions: Seventeen publications were selected from 886 studies and a review of 76 full-text studies. After analysis, a qualitative approach was determined given the clinical and methodological heterogeneity identified between studies. Among the outcomes analysed, diagnostic accuracy in terms of sensitivity and specificity for DD showed individual study estimates of between 17% and 100% and 20% and 98%, respectively, and with a reduction in false positives and an increase in false negatives as the prevalence of CM increases. From a scenario in which all lesions are referred for excision, it was found that the implementation of a new procedure in primary care with the possibility of using MD and DD, between 87.7% and 99.9% of pigmented malignant lesions and 84.7% and 99.9% of CM were properly managed. The results provided by the two selected studies reporting on the ability to identify early stage CM using the CM quotient in situ invasive CM or Breslow thickness show inconsistency and imprecision, respectively. From a study combining observation, MD and DD versus visual examination to diagnose CM, excision of benign lesions was reduced by between 58% and 68.7%. The combined use of MD + DD in persons at high risk of CM allows for improved accuracy in taking decisions on whether to excise malignant lesions, with an increase in the percentage of CM among excised lesions at the expense of a reduction in the number of benign lesions excised. When persons are classified by their baseline risk of developing a CM, the combined use of MD and DD increases the probabilities of identifying CM in those at higher risk. In the general population, the combined use of MD and DD together with the experience of the healthcare professional increases the probabilities of identifying a CM by up to four times. Healthcare professionals’ access to dermatoscopy improves their diagnostic confidence and certainty. People may accept and improve diagnostic confidence when DD is introduced into the care process but when faced with a hypothetical technology with 100% diagnostic accuracy, even with the best diagnostic methods such as MD and DD, these are underestimated in people’s confidence by up to 40% compared to the hypothetical value. Compliance with the instructions given to persons to follow up their lesions is affected, for example, by waiting times in the clinic, the correct functioning of reminder systems and especially by the person’s risk factors (the higher the risk, the better the compliance). The combined use of MD + DD can offer a statistically significant reduction in costs per split MC, with an estimated mean reduction in 2012 euros of €548 (95%CI: €65 to €1,856). Based on data from a study conducted in Australia for its health service, the implementation of specialised care and monitoring of patients at high risk of CM with diagnostic support from DD would have a five-year cost saving of between 18.4 million euros and 15.3 million euros, depending on the chosen implementation modality (2017 euros). In the same healthcare scenario, the estimate of the average cost per person at high risk of CM during a 10-year monitoring was in favour of monitoring in specialised centres with access to DD and showed a gain in QALYs of 0.21 compared to standard monitoring in urban areas. There is no indication that the use of DD may affect the moral, cultural, religious or even beliefs of groups of persons. Some persons may feel uncomfortable with the need to obtain full body photographs. In people without known risk factors, MD is the standard test for the identification of malignant pigmented lesions to be confirmed by pathological anatomy. Persons with high CM risk factors may benefit from initial diagnostic testing by MD or DD and monitoring by DD with closer monitoring intervals over time. Initial screening and monitoring of individuals without high CM risk factors by DD does not provide better results in the identification of new pigmented lesions or observation of previous pigmented lesions compared to the use of MD. Based on low-quality tests, the monitoring of people at high or very high CM risk with the combined use of MD and DD proves to be cost effective in healthcare contexts other than the NHS. It would be desirable to have studies that assess the role of DD in the national health system from an economic perspective.

Authors' recommendations: Seventeen publications were selected from 886 studies and a review of 76 full-text studies. After analysis, a qualitative approach was determined given the clinical and methodological heterogeneity identified between studies. Among the outcomes analysed, diagnostic accuracy in terms of sensitivity and specificity for DD showed individual study estimates of between 17% and 100% and 20% and 98%, respectively, and with a reduction in false positives and an increase in false negatives as the prevalence of CM increases. From a scenario in which all lesions are referred for excision, it was found that the implementation of a new procedure in primary care with the possibility of using MD and DD, between 87.7% and 99.9% of pigmented malignant lesions and 84.7% and 99.9% of CM were properly managed. The results provided by the two selected studies reporting on the ability to identify early stage CM using the CM quotient in situ invasive CM or Breslow thickness show inconsistency and imprecision, respectively. From a study combining observation, MD and DD versus visual examination to diagnose CM, excision of benign lesions was reduced by between 58% and 68.7%. The combined use of MD + DD in persons at high risk of CM allows for improved accuracy in taking decisions on whether to excise malignant lesions, with an increase in the percentage of CM among excised lesions at the expense of a reduction in the number of benign lesions excised. When persons are classified by their baseline risk of developing a CM, the combined use of MD and DD increases the probabilities of identifying CM in those at higher risk. In the general population, the combined use of MD and DD together with the experience of the healthcare professional increases the probabilities of identifying a CM by up to four times. Healthcare professionals’ access to dermatoscopy improves their diagnostic confidence and certainty. People may accept and improve diagnostic confidence when DD is introduced into the care process but when faced with a hypothetical technology with 100% diagnostic accuracy, even with the best diagnostic methods such as MD and DD, these are underestimated in people’s confidence by up to 40% compared to the hypothetical value. Compliance with the instructions given to persons to follow up their lesions is affected, for example, by waiting times in the clinic, the correct functioning of reminder systems and especially by the person’s risk factors (the higher the risk, the better the compliance). The combined use of MD + DD can offer a statistically significant reduction in costs per split MC, with an estimated mean reduction in 2012 euros of €548 (95%CI: €65 to €1,856). Based on data from a study conducted in Australia for its health service, the implementation of specialised care and monitoring of patients at high risk of CM with diagnostic support from DD would have a five-year cost saving of between 18.4 million euros and 15.3 million euros, depending on the chosen implementation modality (2017 euros). In the same healthcare scenario, the estimate of the average cost per person at high risk of CM during a 10-year monitoring was in favour of monitoring in specialised centres with access to DD and showed a gain in QALYs of 0.21 compared to standard monitoring in urban areas. There is no indication that the use of DD may affect the moral, cultural, religious or even beliefs of groups of persons. Some persons may feel uncomfortable with the need to obtain full body photographs. In people without known risk factors, MD is the standard test for the identification of malignant pigmented lesions to be confirmed by pathological anatomy. Persons with high CM risk factors may benefit from initial diagnostic testing by MD or DD and monitoring by DD with closer monitoring intervals over time. Initial screening and monitoring of individuals without high CM risk factors by DD does not provide better results in the identification of new pigmented lesions or observation of previous pigmented lesions compared to the use of MD. Based on low-quality tests, the monitoring of people at high or very high CM risk with the combined use of MD and DD proves to be cost effective in healthcare contexts other than the NHS. It would be desirable to have studies that assess the role of DD in the national health system from an economic perspective.

Authors' methods: This assessment focused on comparing the diagnostic reliability of DD for CM with manual dermatoscopy plus photography (MD+P), its efficiency and the patients’ values and preferences. A search of biomedical databases, a reverse search of selected studies and weekly active alerts were created up to the final edition of the report. Free and controlled language search terms were used. Initially defined study inclusion and exclusion criteria were followed for study selection. Study quality assessment tools were used and an initial work proposal was prepared using the GRADE method.

Project Status: Completed

Year Published: 2022

URL for published report: https://www.iacs.es/wp-content/uploads/2022/06/I24-IACS-2019-Dermatoscopia-Digital_DEF_NIPO.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Health Sciences Institute in Aragon (IACS)

Contact Address: Avda, San Juan Bosco, 13, planta 2

Contact Name: María Pilar Calvo Pérez

Contact Email: direccion.iacs@aragon.es