Ont Health Technol Assess Ser. 2021 Jun 4;21(5):1-81. eCollection 2021.
Early detection of melanoma is key, as survival rates are substantially better when the cancer is detected in its early stages. Currently, the standard of care is to biopsy any lesion suspected of melanoma for diagnostic confirmation by histopathology. As a result, most people who undergo biopsy receive negative melanoma results. If effective, a non-invasive alternative, such as pigmented lesion assay, could minimize the number of unnecessary biopsies performed. We conducted a health technology assessment of pigmented lesion assay for people with suspected melanoma lesions, which included an evaluation of diagnostic accuracy, clinical utility, the budget impact of publicly funding pigmented lesion assay, and the preferences and values of people who have undergone biopsy for suspected melanoma.
We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) and the Risk of Bias Assessment Tool for Non-randomized Studies (RoBANS). We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic literature search of the economic evidence. We also analyzed the budget impact of publicly funding pigmented lesion assay in adults with suspected melanoma in Ontario. To contextualize the potential value of pigmented lesion assay, we spoke with people who had undergone skin biopsy for melanoma. We also used the qualitative research synthesis from a report by the Canadian Agency for Drugs and Technologies in Health to provide context for the preferences and values of those with suspected melanoma.
We included seven studies in the clinical evidence review. Pigmented lesion assay has a sensitivity of 79% (95% confidence interval [CI] 58%-93%) and a specificity of 80% (95% CI 73%-85%; GRADE: Low). We found one published cost-effectiveness study with potentially serious limitations. Therefore, the cost-effectiveness of pigmented lesion assay compared with the standard care pathway is currently uncertain. Assuming a very low uptake, we estimated that the budget impact of publicly funding pigmented lesion assay in Ontario over the next 5 years is about $3.44 million if the test is used exclusively by primary care providers, or about $2.56 million if it is used exclusively by specialists. The people with whom we spoke who had experienced biopsy for suspected melanoma responded positively to the potential benefits of pigmented lesion assay, emphasizing its ease-of-use, potential increase in early detection of melanoma, and reduction in physical and emotional burden of unnecessary biopsies. Participants also felt that the accuracy of this tool was essential to ensure minimal false negatives.
There is uncertainty because of the low-quality evidence for the diagnostic accuracy of pigmented lesion assay. The cost-effectiveness of pigmented lesion assay compared with standard care is also uncertain. We estimated that publicly funding pigmented lesion assay in Ontario over the next 5 years would result in additional costs of $3.44 million (if used exclusively by primary care providers) or $2.56 million (if used exclusively by specialists). For people who had experienced biopsy for suspected melanoma, it was felt that pigmented lesion assay could represent an effective tool to increase early detection and avoid unnecessary biopsies, if the tool was accurate.
早期发现黑色素瘤至关重要，因为在癌症早期发现时，生存率会大大提高。目前，标准的治疗方法是对疑似黑色素瘤的任何病变进行活检，以通过组织病理学进行诊断确认。因此，大多数接受活检的人都会得到黑色素瘤阴性的结果。如果有效，一种非侵入性的替代方法，如色素病变检测，可能会最大限度地减少不必要的活检数量。我们对疑似黑色素瘤病变的人进行了色素病变检测的卫生技术评估，其中包括评估诊断准确性、临床实用性、公众资助色素病变检测的预算影响，以及接受过疑似黑色素瘤活检的人的偏好和价值观。
我们对临床证据进行了系统的文献搜索。我们使用了诊断准确性研究的质量评估-2（QUADAS-2）和非随机研究的偏倚风险评估工具（RoBANS）来评估每个纳入研究的偏倚风险。我们根据推荐评估、制定和评估（GRADE）工作组的标准评估证据的质量。我们对经济证据进行了系统的文献搜索。我们还分析了在安大略省对疑似黑色素瘤的成年人进行公众资助色素病变检测的预算影响。为了使色素病变检测的潜在价值具有现实意义，我们与接受过黑色素瘤皮肤活检的人进行了交谈。我们还使用了加拿大药物和技术评估机构报告中的定性研究综合报告，为那些有疑似黑色素瘤的人的偏好和价值观提供了背景信息。
我们在临床证据综述中纳入了 7 项研究。色素病变检测的敏感性为 79%（95%置信区间[CI] 58%-93%），特异性为 80%（95% CI 73%-85%；GRADE：低）。我们发现了一项具有潜在严重局限性的已发表的成本效益研究。因此，目前尚不确定色素病变检测与标准治疗途径相比的成本效益。假设采用极低的采用率，我们估计，如果仅由初级保健提供者使用，安大略省在未来 5 年内公众资助色素病变检测的预算影响约为 3440 万美元，如果仅由专科医生使用，预算影响约为 2560 万美元。我们交谈过的那些因疑似黑色素瘤而接受过活检的人对色素病变检测的潜在好处反应积极，强调了它的易用性、对黑色素瘤的早期检测的潜在提高，以及减少不必要活检的身体和情感负担。参与者还认为，该工具的准确性对于确保最小的假阴性至关重要。
由于色素病变检测的诊断准确性的低质量证据，存在不确定性。与标准护理相比，色素病变检测的成本效益也不确定。我们估计，如果在安大略省未来 5 年内由初级保健提供者（如果仅由初级保健提供者使用）或专家（如果仅由专家使用）提供公众资助色素病变检测，将额外增加 3440 万美元（如果仅由初级保健提供者使用）或 2560 万美元（如果仅由专家使用）的成本。对于那些因疑似黑色素瘤而接受过活检的人来说，如果该工具准确，他们认为色素病变检测可以成为一种有效的工具，可以提高早期检测率，避免不必要的活检。
