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Algorithm based smartphone apps to assess risk of skin cancer in adults: systematic review of diagnostic accuracy studies

BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m127 (Published 10 February 2020) Cite this as: BMJ 2020;368:m127

Linked Editorial

The poor performance of apps assessing skin cancer risk

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SkinVision response to: Algorithm based smartphone apps to assess risk of skin cancer in adults: systematic review of diagnostic accuracy studies

Dear Editor,

We are writing regarding your recently published research on SkinVision. We are proud that the authors have taken the time to research how technology can positively impact the quality of skin cancer care. At SkinVision, we take the health of our users seriously. Therefore, research has always been a cornerstone of our business. The latest study, not included in the authors’ overall assessment, proves that SkinVision can detect 95% of skin cancer cases (https://onlinelibrary.wiley.com/doi/10.1111/jdv.15935). The sensitivity of general practitioners ranges from 61% and 66%, while the sensitivity of dermatologists is between 75% and 92%.[1-6] SkinVision’s specificity is also on par with the standard of care and is reported in multiple published studies and on our website.

It’s estimated that one in five people may be diagnosed with skin cancer in their lifetime and that, when detected in an early stage, the vast majority of skin cancer cases are cured. Therefore, we aim to raise awareness of skin cancer at an individual level and to provide a regulated medical device to help users assess their risk and get to the doctor in time. We believe that for the benefit of public health, all algorithm-based smartphone Apps should be researched and would like to continue to lead by example, as we continue supporting further clinical research on our algorithm. SkinVision’s service is proven as safe, and its effectiveness continuously benefits National Healthcare Systems (e.g. NHS), hospitals (e.g. Erasmus Rotterdam) and insurers, by having a positive impact on both cancer and non-cancer cases.

SkinVision goes beyond legal and regulatory minimum requirements.

Specifically, as reported in the article, our device is currently determined by regulatory requirements as being Class I. However, SkinVision recognises that provisions for Class I may be supplemented in the interest of public health, and therefore goes beyond them, and voluntarily calls an independent Notified Body to certify its operations. In fact, the BMJ article fails to acknowledge that SkinVision decided to take safety seriously in all areas, for example by achieving voluntary certification to ISO 13485 (best practice quality systems for ensuring safety of medical devices), by achieving voluntary certification to ISO 27001 (best practice for information security systems), and by complying to ISO 14971 (risk management for medical devices).

Additionally, based on current regulations, SkinVision may have been able to market the device based on a smaller set of clinical studies than what we did; however, proving our commitment to safety, we (once again) do more than required, and we continuously invest on new studies, which investigate safety and performance of our device in clinical environments.

Furthermore, SkinVision would like to point out that the article does not consider key factors. Specifically:

1) The most recent study, which proves that SkinVision has a sensitivity of 95%, is not factored in the BMJ article. The study was published in 2019, so the argument of being too recent to be included does not hold ground for an up to date journal like the BMJ.
2) The BMJ article does not emphasise the fact that, even if no apps are used, the standard of care for skin cancer (e.g. doctors or other medical devices) has a large number of false negatives and missed cancers.
3) The use of SkinVision also facilitates access to healthcare globally and reduces unnecessary referrals to dermatologists. This helps healthcare professionals to concentrate on value-added activities.
4) The BMJ article does not consider that decisions on medical devices are not merely done on risk, but rather on risk associated with risk-benefit analysis, which is standardised by ISO 14971 - to which SkinVision complies.
5) The BMJ article compares large studies with positive outcomes with analysis (conducted in unclear circumstances) on 15 people, which allegedly has negative outcomes.
6) The BMJ article may give the impression that no third party certifies SkinVision, which is instead certified by an official EU Notified Body, through multiple on-site assessments and audits per year.

While there are risks associated with all medical devices, research also shows that the use of algorithm-based apps alongside healthcare professionals can provide a greater benefit for patients and the healthcare system. We have assisted in finding over 40,000 cases of skin cancer already. SkinVision believes that a health system with Apps and doctors together can reduce risk for the overall population, and SkinVision is focusing its future research on providing additional data on this.

These objective facts prove that the clinical benefits of the service outweigh the potential risks.

SkinVision welcomes research on its application. However, it is regrettable that article authors did not even contact SkinVision, which could have provided input to help their research to be more effective, and based on real-life data, rather than being a theoretical essay on potential risks that may already exist with current (App free) standard of care for skin cancer.

Detecting all cases of melanoma and skin cancer has never been the objective or the claim of SkinVision, which instead clearly advertises that its sensitivity is not 100%. No medical device is free of risk, and no standard of care can detect all cases of melanoma and skin cancer.

The article conclusions (‘Current algorithm based smartphones apps cannot be relied on to detect all cases of melanoma or other skin cancer. [...]”) have been written in a way that maybe (and has been) easily misinterpreted by general press in a way that press may believe that there is scientific evidence proving a negative impact on public health when using smartphone Apps, which is not the case.

Therefore, SkinVision finds the BMJ article and its conclusion as potentially: a) not giving a fair representation of facts; b) misleading and c) not in the interest of public health.

Considering the need for improving the efficiency and reducing the workload on global healthcare systems, SkinVision looks forward to further supporting population health and to achieving our mission of saving 250,000 lives in the next decade.

Whichever party would like to reach out to SkinVision for further information or statements, is welcome to do so by emailing info@skinvision.com.

Trustfully,

Erik de Heus, CEO
SkinVision

References

1. Ahmadi K, Prickaerts E, Smeets JGE et al. Current approach of skin lesions suspected of malignancy in general practice in the Netherlands: a quantitative overview. J Eur Acad Dermatol Venereol. 2018;32(2):236-241.
2. Beecher SM, Keogh C, Healy C. Dedicated general practitioner education sessions can improve diagnostic capabilities and may have a positive effect on referral patterns for common skin lesions. Ir J Med Sci. 2018;187(4):959-963.
3. Corbo MD, Vender R, Wismer J. Comparison of dermatologists’ and nondermatologists’ diagnostic accuracy for malignant melanoma. J Cutan Med Surg. 2012;16(4):272-80.
4. Kroemer S, Frühauf J, Campbell TM, et al. Mobile teledermatology for skin tumour screening: diagnostic accuracy of clinical and dermoscopic image tele-evaluation using cellular phones. Br J Dermatol. 2011;164(5):973-9.
5. Rosendahl C, Tschandl P, Cameron A et al. Diagnostic accuracy of dermatoscopy for melanocytic and nonmelanocytic pigmented lesions. J Am Acad Dermatol. 2011;64(6):1068-73.
6. Sinz C, Tschandl P, Rosendahl C Accuracy of dermatoscopy for the diagnosis of nonpigmented cancers of the skin. J Am Acad Dermatol. 2017;77(6):1100-1109.

Competing interests: No competing interests

19 February 2020
Erik de Heus
CEO
SkinVision
Amsterdam, the Netherlands