Use of artificial intelligence, or machine learning, to assess dermoscopic images of skin lesions to detect melanoma has in several retrospective studies shown high levels of diagnostic accuracy on par with, or even outperforming, experienced dermatologists. However, the enthusiasm around these algorithms has not yet been matched by prospective clinical trials performed in authentic clinical settings. In several European countries, including Sweden, the initial clinical assessment of suspected skin cancer is principally conducted in the primary health care setting by primary care physicians; with or without access to teledermoscopic support from dermatology clinics. To determine the diagnostic performance of an artificial intelligence-based clinical decision support tool for cutaneous melanoma detection, operated by a smartphone application (app), when used prospectively by primary care physicians to assess skin lesions of concern due to some degree of melanoma suspicion. This prospective, multicentre, clinical trial was conducted at 36 primary care centres in Sweden. The physicians used the smartphone app on skin lesions of concern by photographing them dermoscopically, which resulted in a dichotomous decision support text regarding evidence for melanoma. Regardless of the app outcome, all lesions underwent standard diagnostic procedure, by surgical excision or referral to dermatologist. After completed investigation, lesion diagnoses were collected from the patients’ medical records and compared to app outcome and other lesion data. In total, 253 lesions of concern in 228 patients were included, of which 21 proved to be melanomas, with 11 thin invasive melanomas and 10 melanomas in situ. The app’s accuracy (95% confidence interval) in identifying melanomas was reflected in an area under the receiver operating characteristic (AUROC) curve of 0.960 (0.928-0.980), corresponding to a maximum sensitivity and specificity of 95.2% and 84.5%, respectively. For invasive melanomas alone, the AUROC was 0.988 (0.965–0.997), corresponding to a maximum sensitivity and specificity of 100% and 92.6%, respectively. The clinical decision support tool evaluated in this investigation showed high diagnostic accuracy when used prospectively on primary care patients, which could add significant clinical value for primary care physicians in assessing skin lesions to detect melanoma. ClinicalTrials.gov Identifier: NCT05172232

Objective: Skin examination to detect cutaneous melanomas is commonly performed in primary care. In recent years, clinical decision support systems (CDSS) based on artificial intelligence (AI) have been introduced within several diagnostic fields.Setting: This study employs a variety of qualitative and quantitative methodologies to investigate the feasibility of an AI-based CDSS to detect cutaneous melanoma in primary care.Subjects and Design: Fifteen primary care physicians (PCPs) underwent near-live simulations using the CDSS on a simulated patient, and subsequent individual semi-structured interviews were explored with a hybrid thematic analysis approach. Additionally, twenty-five PCPs performed a reader study (diagnostic assessment on the basis of image interpretation) of 18 dermoscopic images, both with and without help from AI, investigating the value of adding AI support to a PCPs decision. Perceived instrument usability was rated on the System Usability Scale (SUS).Results: From the interviews, the importance of trust in the CDSS emerged as a central concern. Scientific evidence supporting sufficient diagnostic accuracy of the CDSS was expressed as an important factor that could increase trust. Access to AI decision support when evaluating dermoscopic images proved valuable as it formally increased the physician's diagnostic accuracy. A mean SUS score of 84.8, corresponding to 'good' usability, was measured.Conclusion: AI-based CDSS might play an important future role in cutaneous melanoma diagnostics, provided sufficient evidence of diagnostic accuracy and usability supporting its trustworthiness among the users.

Background: There is a need to accelerate digital transformation in healthcare to meet increasing needs and demands. The accuracy of medical digital diagnosis tools is improving. The introduction of new technology in healthcare can however be challenging and it is unclear how it should be done to reach desired results. The aim of this study was to explore perceptions and experiences of introducing new Information Technology (IT) in a primary healthcare organisation, exemplified with a Clinical Decision Support System (CDSS) for malignant melanoma. Methods: A qualitative interview-based study was performed in Region Stockholm, Sweden, with fifteen medical doctors representing three different organisational levels – primary care physician, primary healthcare centre manager, and regional manager/chief medical officer. In addition, one software provider was included. Interview data were analysed according to content analysis. Results: One central theme “Introduction of digital CDSS in primary healthcare requires a multidimensional perspective and handling” along with seven main categories and thirty-three subcategories emerged from the analysis. Digital transformation showed to be key for current healthcare providers to stay relevant and competitive. However, healthcare represents a closed community, very capable but with lack of time, fostered to be sceptical to new why change needs to bring true value and be inspired by people with medical background to motivate the powerful frontline. Conclusions: This qualitative study revealed structured information of what goes wrong and right and what needs to be considered when driving digital change in primary care organisations. The task shows to be complex and the importance of listening to the voice of healthcare is valuable for understanding the conditions that need to be fulfilled when adopting new technology into a healthcare organization. By considering the findings of this study upcoming digital transformations can improve their success-rate. The information may also be used in developing a holistic approach or framework model, adapted to primary health care, that can support and accelerate the needed digitalization in healthcare as such.

Background: Cyber threats are increasing across all business sectors, with health care being a prominent domain. In response to the ever-increasing threats, health care organizations (HOs) are enhancing the technical measures with the use of cybersecurity controls and other advanced solutions for further protection. Despite the need for technical controls, humans are evidently the weakest link in the cybersecurity posture of HOs. This suggests that addressing the human aspects of cybersecurity is a key step toward managing cyber-physical risks. In practice, HOs are required to apply general cybersecurity and data privacy guidelines that focus on human factors. However, there is limited literature on the methodologies and procedures that can assist in successfully mapping these guidelines to specific controls (interventions), including awareness activities and training programs, with a measurable impact on personnel. To this end, tools and structured methodologies for assisting higher management in selecting the minimum number of required controls that will be most effective on the health care workforce are highly desirable. Objective: This study aimed to introduce a cyber hygiene (CH) methodology that uses a unique survey-based risk assessment approach for raising the cybersecurity and data privacy awareness of different employee groups in HOs. The main objective was to identify the most effective strategy for managing cybersecurity and data privacy risks and recommend targeted human-centric controls that are tailored to organization-specific needs. Methods: The CH methodology relied on a cross-sectional, exploratory survey study followed by a proposed risk-based survey data analysis approach. First, survey data were collected from 4 different employee groups across 3 European HOs, covering 7 categories of cybersecurity and data privacy risks. Next, survey data were transcribed and fitted into a proposed risk-based approach matrix that translated risk levels to strategies for managing the risks. Results: A list of human-centric controls and implementation levels was created. These controls were associated with risk categories, mapped to risk strategies for managing the risks related to all employee groups. Our mapping empowered the computation and subsequent recommendation of subsets of human-centric controls to implement the identified strategy for managing the overall risk of the HOs. An indicative example demonstrated the application of the CH methodology in a simple scenario. Finally, by applying the CH methodology in the health care sector, we obtained results in the form of risk markings; identified strategies to manage the risks; and recommended controls for each of the 3 HOs, each employee group, and each risk category. Conclusions: The proposed CH methodology improves the CH perception and behavior of personnel in the health care sector and provides risk strategies together with a list of recommended human-centric controls for managing a wide range of cybersecurity and data privacy risks related to health care employees.

The non-canonical Wnt/Planar cell polarity (PCP) signaling pathway is a major player in cell migration during embryonal development and has recently been implicated in tumorigenesis. Transfections with cDNA plasmids or siRNA were used to increase and suppress Prickle1 and Vangl2 expression in neuroblastoma cells and in non-tumorigenic cells. Cell viability was measured by trypan blue exclusion and protein expression was determined with western blotting. Transcriptional activity was studied with luciferase reporter assay and mRNA expression with real-time RT-PCR. Immunofluorescence stainings were used to study the effects of Vangl2 overexpression in non-tumorigenic embryonic cells. Statistical significance was tested with t-test or one-way ANOVA. Here we show that high expression of the PCP core genes Prickle1 and Vangl2 is associated with low-risk neuroblastoma, suppression of neuroblastoma cell growth and decreased Wnt/β-catenin signaling. Inhibition of Rho-associated kinases (ROCKs) that are important in mediating non-canonical Wnt signaling resulted in increased expression of Prickle1 and inhibition of β-catenin activity in neuroblastoma cells. In contrast, overexpression of Vangl2 in MYC immortalized neural stem cells induced accumulation of active β-catenin and decreased the neural differentiation marker Tuj1. Similarly, genetically modified mice with forced overexpression of Vangl2 in nestin-positive cells showed decreased Tuj1 differentiation marker during embryonal development. Our experimental data demonstrate that high expression of Prickle1 and Vangl2 reduce the growth of neuroblastoma cells and indicate different roles of PCP proteins in tumorigenic cells compared to normal cells. These results suggest that the activity of the non-canonical Wnt/PCP signaling pathway is important for neuroblastoma development and that manipulation of the Wnt/PCP pathway provides a possible therapy for neuroblastoma.