The Clinical Utility of a Handheld Elastic Scattering Spectroscopy Tool and Machine Learning in the Diagnosis and Referral Management of Skin Cancer by Primary Care Physicians

Background Elastic scattering spectroscopy (ESS) is a noninvasive optical biopsy technique that can distinguish between normal and abnormal tissue in vivo. The handheld device measures ESS spectra of skin lesions and classifies lesions with an output of “Investigate Further” or “Monitor.” The algorithm was trained and validated with over 11,000 spectral scans from over 3500 skin lesions. The device performance was also evaluated in an associated clinical study. Objective The aim of this paper was to establish whether the use of a handheld ESS tool can improve the detection of skin malignancies by evaluating clinical performance while emulating a real-world telemedicine clinical care setting. Methods The associated clinical study examined an independent test set of 332 lesions in a prospective multicenter study that compared algorithm performance to biopsy results for diagnosing malignant lesions. A total of 50 cases were randomly selected from the study data base (25 malignant and 25 benign lesions). Device performance on these lesions had a 96% sensitivity. High-resolution digital images and the patient’s clinical information including prior skin cancer history, risk factors, and physical examination results were available for evaluation. A total of 57 primary care physicians participated in this study in 2 phases, the first phase with their standard-of-care diagnostic and the second phase regarding their evaluation with the device output. The physicians were educated on the ESS device before evaluating the cases in a random order. Case evaluation included the physician reporting their diagnosis, management decision, and confidence level without the device output in the first phase and with the device output in the second phase. The results were evaluated for sensitivity and specificity with confidence intervals. Results The diagnostic sensitivity of the readers without and with the use of the handheld ESS device increased significantly from 67% to 88% (P<.001). There was no significant difference in specificity at 40% and 53% (P=.05). The management sensitivity of the readers increased significantly with and without the use of the device, which, respectively, was 94% (91%-96%) and 81% (77%-85%) (P<.001), suggesting that the use of the device may reduce false negatives by 68%. Specificity was comparable for management decisions (P=.36) at 31% compared to 36% without the device. Conclusions The use of the handheld ESS device significantly improved diagnostic and management sensitivity over standard-of-care, with comparable specificity. While telemedicine has shown promise in many fields, studies have shown that in-person skin evaluation is superior to telemedicine evaluations; however, integration with this type of tool has the potential to improve early detection.

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The Clinical Utility of a Handheld Elastic Scattering Spectroscopy Tool and Machine Learning in the Diagnosis and Referral Management of Skin Cancer by Primary Care Physicians (Preprint)

10.2196/preprints.35440 ◽

2021 ◽

Author(s):

Kelly Tepedino ◽

Todd Thames

Keyword(s):

Primary Care ◽

Clinical Study ◽

Elastic Scattering ◽

Skin Cancer ◽

Primary Care Physicians ◽

Standard Of Care ◽

Skin Lesions ◽

Second Phase ◽

Device Performance ◽

Elastic Scattering Spectroscopy

BACKGROUND Elastic scattering spectroscopy (ESS) is a noninvasive optical biopsy technique that can distinguish between normal and abnormal tissue in vivo. The handheld device measures ESS spectra of skin lesions and classifies lesions with an output of “Investigate Further” or “Monitor.” The algorithm was trained and validated with over 11,000 spectral scans from over 3500 skin lesions. The device performance was also evaluated in an associated clinical study. OBJECTIVE The aim of this paper was to establish whether the use of a handheld ESS tool can improve the detection of skin malignancies by evaluating clinical performance while emulating a real-world telemedicine clinical care setting. METHODS The associated clinical study examined an independent test set of 332 lesions in a prospective multicenter study that compared algorithm performance to biopsy results for diagnosing malignant lesions. A total of 50 cases were randomly selected from the study data base (25 malignant and 25 benign lesions). Device performance on these lesions had a 96% sensitivity. High-resolution digital images and the patient’s clinical information including prior skin cancer history, risk factors, and physical examination results were available for evaluation. A total of 57 primary care physicians participated in this study in 2 phases, the first phase with their standard-of-care diagnostic and the second phase regarding their evaluation with the device output. The physicians were educated on the ESS device before evaluating the cases in a random order. Case evaluation included the physician reporting their diagnosis, management decision, and confidence level without the device output in the first phase and with the device output in the second phase. The results were evaluated for sensitivity and specificity with confidence intervals. RESULTS The diagnostic sensitivity of the readers without and with the use of the handheld ESS device increased significantly from 67% to 88% (P<.001). There was no significant difference in specificity at 40% and 53% (P=.05). The management sensitivity of the readers increased significantly with and without the use of the device, which, respectively, was 94% (91%-96%) and 81% (77%-85%) (P<.001), suggesting that the use of the device may reduce false negatives by 68%. Specificity was comparable for management decisions (P=.36) at 31% compared to 36% without the device. CONCLUSIONS The use of the handheld ESS device significantly improved diagnostic and management sensitivity over standard-of-care, with comparable specificity. While telemedicine has shown promise in many fields, studies have shown that in-person skin evaluation is superior to telemedicine evaluations; however, integration with this type of tool has the potential to improve early detection.

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Teaching Skin Cancer Detection to Medical Students Using a Dermoscopic Algorithm

PRiMER ◽

10.22454/primer.2021.304379 ◽

2021 ◽

Vol 5 ◽

Author(s):

Peggy R. Cyr ◽

Wendy Craig ◽

Hadjh Ahrns ◽

Kathryn Stevens ◽

Caroline Wight ◽

...

Keyword(s):

Primary Care ◽

Medical Students ◽

Skin Cancer ◽

Primary Care Physicians ◽

Survival Rates ◽

Family Physicians ◽

Skin Lesions ◽

Posttest Score ◽

Malignant Skin ◽

Attending Physicians

Introduction: Early detection of melanoma skin cancer improves survival rates. Training family physicians in dermoscopy with the triage amalgamated dermoscopic algorithm (TADA) has high sensitivity and specificity for identifying malignant skin neoplasms. In this study we evaluated the effectiveness of TADA training among medical students, compared with practicing clinicians. Methods: We incorporated the TADA framework into 90-minute workshops that taught dermoscopy to family physicians, primary care residents, and first- and second-year medical students. The workshop reviewed the clinical and dermoscopic features of benign and malignant skin lesions and included a hands-on interactive session using a dermatoscope. All participants took a 30-image pretest and a different 30-image posttest. Results: Forty-six attending physicians, 25 residents, and 48 medical students participated in the workshop. Mean pretest scores were 20.1, 20.3, and 15.8 for attending physicians, resident physicians and students, respectively (P<.001); mean posttest scores were 24.5, 25.9, and 24.1, respectively (P=.11). Pre/posttest score differences were significant (P<.001) for all groups. The medical students showed the most gain in their pretest and posttest scores. Conclusion: After short dermoscopy workshop, medical students perform as well as trained physicians in identifying images of malignant skin lesions. Dermoscopy training may be a valuable addition to the medical school curriculum as this skill can be used by primary care physicians as well as multiple specialists including dermatologists, gynecologists, otolaryngologists, plastic surgeons, and ophthalmologists, who often encounter patients with concerning skin lesions.

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Dermoscopy Improves Accuracy of Primary Care Physicians to Triage Lesions Suggestive of Skin Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2005.05.0864 ◽

2006 ◽

Vol 24 (12) ◽

pp. 1877-1882 ◽

Cited By ~ 125

Author(s):

Giuseppe Argenziano ◽

Susana Puig ◽

Iris Zalaudek ◽

Francesco Sera ◽

Rosamaria Corona ◽

...

Keyword(s):

Primary Care ◽

Skin Cancer ◽

Primary Care Physicians ◽

Randomized Study ◽

Skin Lesions ◽

Skin Cancer Screening ◽

Predictive Values ◽

Naked Eye ◽

Pigmented Lesions ◽

Malignant Skin Tumors

Purpose Primary care physicians (PCPs) constitute an appropriate target for new interventions and educational campaigns designed to increase skin cancer screening and prevention. The aim of this randomized study was to determine whether the adjunct of dermoscopy to the standard clinical examination improves the accuracy of PCPs to triage lesions suggestive of skin cancer. Patients and Methods PCPs in Barcelona, Spain, and Naples, Italy, were given a 1-day training course in skin cancer detection and dermoscopic evaluation, and were randomly assigned to the dermoscopy evaluation arm or naked-eye evaluation arm. During a 16-month period, 73 physicians evaluated 2,522 patients with skin lesions who attended their clinics and scored individual lesions as benign or suggestive of skin cancer. All patients were re-evaluated by expert dermatologists at clinics for pigmented lesions. Referral accuracy of both PCP groups was calculated by their scores, which were compared to those tabulated for dermatologists. Results Referral sensitivity, specificity, and positive and negative predictive values were 54.1%, 71.3%, 11.3%, and 95.8%, respectively, in the naked-eye arm, and 79.2%, 71.8%, 16.1%, and 98.1%, respectively, in the dermoscopy arm. Significant differences were found in terms of sensitivity and negative predictive value (P = .002 and P = .004, respectively). Histopathologic examination of equivocal lesions revealed 23 malignant skin tumors missed by PCPs performing naked-eye observation and only six by PCPs using dermoscopy (P = .002). Conclusion The use of dermoscopy improves the ability of PCPs to triage lesions suggestive of skin cancer without increasing the number of unnecessary expert consultations.

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Training Primary Care Physicians in Dermoscopy for Skin Cancer Detection: a Scoping Review

Journal of Cancer Education ◽

10.1007/s13187-019-01647-7 ◽

2019 ◽

Vol 35 (4) ◽

pp. 643-650 ◽

Cited By ~ 2

Author(s):

Jonathan A. Fee ◽

Finbar P. McGrady ◽

Cliff Rosendahl ◽

Nigel D. Hart

Keyword(s):

Primary Care ◽

Skin Cancer ◽

Cancer Detection ◽

Primary Care Physicians ◽

Training Programs ◽

Meta Analysis ◽

Skin Lesions ◽

Evidence Base ◽

Care Physician ◽

Skin Cancer Detection

AbstractIn many countries, patients with concerning skin lesions will first consult a primary care physician (PCP). Dermoscopy has an evidence base supporting its use in primary care for skin cancer detection, but need for training has been cited as a key barrier to its use. How PCPs train to use dermoscopy is unclear. A scoping literature review was carried out to examine what is known from the published literature about PCP training in dermoscopy. The methodological steps taken in this review followed those described by Arksey and O’Malley, as revised by Levac et al. Four electronic databases were searched for evidence published up to June 2018. Sixteen articles were identified for analysis, all published since 2000. Ten training programs were identified all of which addressed dermoscopy of pigmented skin lesions, among other topics. Ten articles reported on a range of outcomes measured after training and showed generally positive results in terms of improved diagnostic performance, although no meta-analysis was conducted. However, it was unclear whether trained PCPs continued to use dermoscopy after training. Observational questionnaire data revealed that many PCPs use dermoscopy in practice without any formal training. The literature generally supports the use of dermoscopy by PCPs, but it is unclear whether current training leads to long-term change in PCPs’ use of dermoscopy in clinical practice. Understanding this problem, as well as exploring PCPs’ training needs, is essential to develop training programs that will facilitate the uptake and use of dermoscopy in primary care.

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Skin Cancer and Dermoscopy Training for Primary Care Physicians: A Pilot Study

Dermatology Practical & Conceptual ◽

10.5826/dpc.1101a145 ◽

2021 ◽

pp. e2021145

Author(s):

Valeria De Bedout ◽

Natalie Williams ◽

Ana Muñoz ◽

Ana Londoño ◽

Manuela Munera ◽

...

Keyword(s):

Primary Care ◽

Skin Cancer ◽

Diagnostic Accuracy ◽

Rural Areas ◽

Primary Care Physicians ◽

Skin Lesions ◽

Malignant Neoplasms ◽

Seborrheic Keratosis ◽

Skin Cancer Screening ◽

Secondary Objective

Introduction: The primary objective of this study was to determine the diagnostic accuracy and effect of an educational training on skin cancer course and dermoscopy use among primary care physicians in rural areas of Colombia. The secondary objective was to assess the diagnostic accuracy of skin cancer diagnosis and detection rate after 3 months of the initial training. Methods: Twenty-one primary care physicians from 6 rural areas of Colombia participated in a 2-day skin cancer and dermoscopy training, followed by a day-long hands-on session on dermoscopy at a free skin cancer screening event. Pre- and post-tests were performed using clinical and dermoscopic images to evaluate the user’s ability to diagnose and differentiate benign and malignant neoplasms. In addition, participants’ levels of confidence were assessed. Results: After the training, the sensitivity and specificity of characterizing skin lesions as benign or malignant or providing a specific diagnosis (ie, angioma, seborrheic keratosis, basal cell carcinoma, etc.) increased by 23.6% (62.9% to 86.5%; P < 0.0001) and 21% (54.7% to 75.7%; P < 0.0017), respectively. In addition, levels of confidence when diagnosing skin lesions changed from extremely low or low, to high or extremely high by 20.7% (38.3% to 59%) using dermoscopic images (odds ratio (OR) 3.22; 95% confidence interval (CI): 2.67-3.86; P < 0.0001). The secondary objective was not achieved due to loss of follow-up of the majority of participants. Conclusion: Providers serving populations with limited healthcare access may benefit from education in diagnosing and differentiating skin cancer with the use of dermoscopy, which may ultimately improve patient care and reduce healthcare costs.

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THE PREVALENCE OF HUMAN PAPILLOMAVIRUS DNA IN BENIGN KERATOTIC SKIN LESIONS OF RENAL TRANSPLANT RECIPIENTS WITH AND WITHOUT A HISTORY OF SKIN CANCER IS EQUALLY HIGH: A CLINICAL STUDY TO ASSESS RISK FACTORS FOR KERATOTIC SKIN LESIONS AND SKIN CANCER 1

Transplantation Journal ◽

10.1097/00007890-200001150-00009 ◽

2000 ◽

Vol 69 (1) ◽

pp. 44 ◽

Cited By ~ 67

Author(s):

Linda M. de Jong-Tieben ◽

Ron J. M. Berkhout ◽

Jan ter Schegget ◽

Bert J. Vermeer ◽

Johan W. de Fijter ◽

...

Keyword(s):

Risk Factors ◽

Human Papillomavirus ◽

Clinical Study ◽

Skin Cancer ◽

Renal Transplant ◽

Skin Lesions ◽

Renal Transplant Recipients ◽

Transplant Recipients ◽

History Of ◽

Papillomavirus Dna

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Is an online skin cancer toolkit an effective way to educate primary care physicians about skin cancer diagnosis and referral?

Journal of the European Academy of Dermatology and Venereology ◽

10.1111/jdv.13167 ◽

2015 ◽

Vol 29 (11) ◽

pp. 2152-2159 ◽

Cited By ~ 4

Author(s):

A. Gulati ◽

C.A. Harwood ◽

J. Rolph ◽

E. Pottinger ◽

J.M. Mcgregor ◽

...

Keyword(s):

Primary Care ◽

Skin Cancer ◽

Cancer Diagnosis ◽

Primary Care Physicians

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The Safety and Effectiveness of Elastic Scattering Spectroscopy and Machine Learning in the Evaluation of Skin Lesions for Cancer

Iproceedings ◽

10.2196/35441 ◽

2021 ◽

Vol 6 (1) ◽

pp. e35441

Author(s):

Cristiane Benvenuto-Andrade ◽

A Cognetta ◽

D Manolakos

Keyword(s):

Squamous Cell Carcinoma ◽

Elastic Scattering ◽

Basal Cell Carcinoma ◽

Cell Carcinoma ◽

Squamous Cell ◽

Basal Cell ◽

Predictive Value ◽

Prevalence Rate ◽

Skin Lesions ◽

Elastic Scattering Spectroscopy

Background Elastic scattering spectroscopy (ESS) is an optical biopsy technique that can distinguish between a normal and abnormal tissue in vivo without the need to remove it. The handheld device measures ESS spectra of skin lesions and classifies lesions as either malignant or benign with an output of “Investigate Further” or “Monitor,” respectively, with positive results accompanied by a spectral score output from 1 to 10, indicating how similar the lesion is to the malignant lesions the device was trained on. The algorithm was trained and validated with over 11,000 spectral scans from over 3500 skin lesions. Objective The purpose of this study was to evaluate the safety and effectiveness of the handheld ESS device in detecting the most common types of skin cancer. Methods A prospective, single-arm, investigator-blinded, multicenter study conducted at 4 investigational sites in the United States was performed. Patients who presented with skin lesions suggestive of melanoma, basal cell carcinoma, squamous cell carcinoma, and other highly atypical lesions were evaluated with the handheld ESS device. A validation performance analysis was performed with 553 lesions from 350 subjects with algorithm version 2.0. An independent test set of 281 lesions was selected and used to evaluate device performance in the detection of melanoma, basal cell carcinoma (BCC), and squamous cell carcinoma (SCC). Statistical analyses included overall effectiveness analyses for sensitivity and specificity as well as subgroup analyses for lesion diagnoses. Results The overall sensitivity of the device was 92.3% (95% CI: 87.1 to 95.5%). The sensitivity for subgroups of lesions was 95% (95% CI 75.1% to 99.9%) for melanomas, 94.4% (95% CI 86.3% to 98.4%) for BCCs, and 92.5% (95% CI 83.4% to 97.5%) for SCCs. The overall device specificity was 36.6% (95% CI 29.3% to 44.6%). There was no statistically significant difference between the dermatologist performance and the ESS device (P=.2520). The specificity of the device was highest for benign melanocytic nevi (62.5%) and seborrheic keratoses (78.2%). The overall positive predictive value (PPV) was 59.8%, and the negative predictive value (NPV) was 81.9% with the study’s malignancy prevalence rate of 51%. For a prevalence rate of 5%, the PPV was estimated to be 7.1%, and the NPV was estimated to be 98.9%. For a prevalence rate of 7%, the PPV was estimated to be 9.8%, and the NPV was estimated to be 98.4%. For a prevalence rate of 15%, the PPV was estimated to be 20.3%, and the NPV was 96.4%. Conclusions The handheld ESS device has a high sensitivity for the detection of melanoma, BCC, and SCC. Coupled with clinical exam findings, this device can aid physicians in detecting a variety of skin malignancies. The device output can aid teledermatology evaluations by helping frontline providers determine which lesions to share for teledermatologist evaluation as well as potentially benefitting teledermatologists’ virtual evaluation, especially in instances of suboptimal photo quality. Acknowledgments This study was sponsored by Dermasensor Inc. Conflicts of Interest None declared.

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