Who submitted concerns?
In this paper we report data from only those members of the intervention group who notified at least one concern about their skin to the study DNP during the ASICA study. Full details of recruitment and retention will be reported elsewhere along with the main trial results. Table 1 shows key demographics and the site of primary melanoma for the 121 members of the intervention group and those 69 members who submitted concerns to the DNP using the ASICA app during their 12 months of receiving the ASICA intervention. Compared to the intervention group overall, those submitting concerns tended to be younger and more ljkely to live in a rural setting. Notably, of six study recruits from the most deprived quintile, only 1 one submitted a concern during the study year. Of those who submitted a concern or image, 61 were active concerns whilst eight were test images only. Submitters from the Grampian site numbered 49 (68%) with 20 (32%) from the Cambridge site. There were slightly more females than males (55.1% to 44.9). The mean age was 57.5 years (SD 13.6 years), but participants reporting concerns had a wide range of ages, both younger and older patients. Overall 6 (8.7%) participants resided in the most-deprived five deciles compared to 15 (22%) coming from the single most affluent decile.[Scottish Government 2020; UK Government 2019] Over half of the sample were rural-dwellers (n=38 (55.1%), with a similar proportion of individuals at each site living rurally, 28 (51.9%) from Grampian and 10 (50.0%) from Cambridge.
How often were concerns submitted?
During the 12 months follow up, 61 participants reported active concerns using the ASICA app on 129 occasions [Median 2; Interquartile range (IQR) 1-2; Range (1-8)] (Table 2). The majority of reports comprised one or two concerns (109/129 (84%)), but on 14 occasions between three and eight separate concerns were included and detailed in the report (table 2). Thus although 129 separate reports were submitted, they included a total of 190 separate skin concerns. The number of separate skin concerns submitted by any one individual throughout the trial varied from 1 - 16 [Median 2; IQR 1-3].
What was the range and nature of concerns submitted?
Table 3 summarizes the number of reports submitted and whether they related to the first primary or another site. Approximately 62% (117/189) of reports submitted detailed concerns at sites other than the primary. Concerns about a new mole or changes to existing moles accounted for almost 60% of reports submitted. Further, 20% of concerns detailed “other concerns” such as skin rashes (2 diagnoses of shingles), nail changes and other types of non-pigmented skin lesions. Body location of reported concerns were roughly evenly distributed among head and neck, upper and lower limbs and torso, with a smaller number (6/189 (3.2%)) arising in the pelvic area. No restriction had been placed on submitting concerns from intimate body areas.
How good were the skin photographs that were submitted?
Almost a quarter (45/188 (23.9%)) of initially submitted skin photographs were of prime focused quality, with some blurring reported by the DNP in around two thirds (118/188 (62.7%)) (Table 4). Nevertheless 79 (41.4%) skin photographs were of sufficient quality to make a clinical decision. Further skin photographs were requested by the DNP on 111 occasions (58.6%). The patient returned these on 48 occasions (25.5%) but did not on 61 (33.5%) occasions. The rate of default appeared higher (53.5% vs 21.2%) in the Cambridge patients.
How were participant concerns resolved?
Of the 189 concerns reported 188 included a skin photograph. 62 (32.8%) concerns were resolved with the initial images sent. On 28 occasions (14.8%) further images were requested and received by the DNP enabling remote resolution, 14 (7.4%) participants were referred to their GP and for 19 (10.1%) participants an appointment was arranged at a face-to-face dermatology clinic. In around one third (66/189) of reports, the participants who reported a concern did not respond to a subsequent request for further images, with the DNP having made an assessment that the issue was initially benign for 17 of these. However, in total, this means that 49 concerns were not resolved by the DNP within the trial. It is important to be quite clear, however, that this had been anticipated in design and that the ASICA intervention was being delivered to participants in addition to their usual follow-up and primary and secondary care.
The range of assessments made by the DNP on participant reports of concern are shown in Table 5. The 61 “Benign (non-specific)” assessments were occasions where the DNP indicated that he was unconcerned by the issue and skin photographs submitted, and is likely to have been slightly inflated by the fact that the trial clinician portal for receiving and detailing the assessment of submitted reports was improved about midway through the study enabling more clinical detail to be collected..
Adherence and the timing of interactions with the ASICA intervention will be discussed in detail in a future paper. However, it was observed that individuals varied considerably in the interval between training and the first report of a concern being submitted. The first report was received within one month from 29 (42.0%) participants. The first report was received between one and three months by 20 (29.0%) participants, between three and six months from 11 (15.9%) participants and between six and 12 months from a further 9 (13.0%) participants. This demonstrates that the timing of individuals submitting their first report was spread throughout the study period and not clustered around training dates.
What significant clinical events occurred?
Table 6 details significant clinical events (diagnoses of metastatic melanoma, new primary melanoma and dysplastic naevi) and episodes where an ASICA report led to the DNP referring a patient to their GP or arranging for them to be seen face-to-face by a skin specialist in a secondary care clinic. As a result of using ASICA, 14 participants were referred to their GP and 19 face-to-face assessments were arranged at a dermatology outpatient clinic. We are not able to report on the detailed outcome of all these primary and secondary care encounters since we did not have sufficient access to primary and secondary care case-notes to triangulate these completely. Furthermore, due to the timescales involved not all episodes were concluded within the trial follow up period, with some appointments, results and procedures outstanding. We did, however, also collect data by self-report on numbers of skin-related GP appointments, numbers of skin-related hospital appointments and admissions and numbers of hospital-based skin procedures in the 3, 6 and 12 month follow up questionnaires from all participants (both those in the intervention arm and those in the standard care arm). This will be reported in a subsequent paper but within the constraints of the current feasibility trial it is not possible to link these directly to ASICA use. We also collected data on diagnoses of recurrent melanoma and metastatic melanoma, new primary melanoma and new dysplastic lesions in the 12-month clinic reviews, since these are potential outcomes in a definitive trial of ASICA. Whilst we were able to collect this data, these events were rare with only two ASICA participants being diagnosed with metastatic melanoma, one with a new primary melanoma and one with two dysplastic naevi. These four events are detailed in Table 6 although, all occurred in the period between randomization and patients being trained and receiving the intervention. Thus, ASICA was not directly involved in any of these diagnoses. Table 6 also includes details of 5 of the 19 cases where patients were brought to a secondary care clinic for face to face assessment. These were completely resolved, and the DNP was closely involved and able to provide details. These data are included to demonstrate practical applications of the intervention in a real-world setting.