Helfand M, Mahon S M, Eden K B, Frame P S, Orleans C T
Division of Medical Informatics and Outcomes Research, Evidence-based Practice Center, Oregon Health Sciences University, Portland, Oregon 97201-3098, USA.
Am J Prev Med. 2001 Apr;20(3 Suppl):47-58. doi: 10.1016/s0749-3797(01)00258-6.
Malignant melanoma is often lethal, and its incidence in the United States has increased rapidly over the past 2 decades. Nonmelanoma skin cancer is seldom lethal, but, if advanced, can cause severe disfigurement and morbidity. Early detection and treatment of melanoma might reduce mortality, while early detection and treatment of nonmelanoma skin cancer might prevent major disfigurement and to a lesser extent prevent mortality. Current recommendations from professional societies regarding screening for skin cancer vary.
To examine published data on the effectiveness of routine screening for skin cancer by a primary care provider, as part of an assessment for the U.S. Preventive Services Task Force.
We searched the MEDLINE database for papers published between 1994 and June 1999, using search terms for screening, physical examination, morbidity, and skin neoplasms. For information on accuracy of screening tests, we used the search terms sensitivity and specificity. We identified the most important studies from before 1994 from the Guide to Clinical Preventive Services, second edition, and from high-quality reviews. We used reference lists and expert recommendations to locate additional articles.
Two reviewers independently reviewed a subset of 500 abstracts. Once consistency was established, the remainder were reviewed by one reviewer. We included studies if they contained data on yield of screening, screening tests, risk factors, risk assessment, effectiveness of early detection, or cost effectiveness.
We abstracted the following descriptive information from full-text published studies of screening and recorded it in an electronic database: type of screening study, study design, setting, population, patient recruitment, screening test description, examiner, advertising targeted at high-risk groups or not targeted, reported risk factors of participants, and procedure for referrals. We also abstracted the yield of screening data including probabilities and numbers of referrals, types of suspected skin cancers, biopsies, confirmed skin cancers, and stages and thickness of skin cancers. For studies that reported test performance, we recorded the definition of a suspicious lesion, the "gold-standard" determination of disease, and the number of true positive, false positive, true negative, and false negative test results. When possible, positive predictive values, likelihood ratios, sensitivity, and specificity were recorded.
No randomized or case-control studies have been done that demonstrate that routine screening for melanoma by primary care providers reduces morbidity or mortality. Basal cell carcinoma and squamous cell carcinoma are very common, but detection and treatment in the absence of formal screening are almost always curative. No controlled studies have shown that formal screening programs will improve this already high cure rate. While the efficacy of screening has not been established, the screening procedures themselves are noninvasive, and the follow-up test, skin biopsy, has low morbidity. Five studies from mass screening programs reported the accuracy of skin examination as a screening test. One of these, a prospective study, tracked patients with negative results to determine the number of patients with false-negative results. In this study, the sensitivity of screening for skin cancer was 94% and specificity was 98%. Several recent case-control studies confirm earlier evidence that risk of melanoma rises with the presence of atypical moles and/or many common moles. One well-done prospective study demonstrated that risk assessment by limited physical exam identified a relatively small (<10%) group of primary care patients for more thorough evaluation.
The quality of the evidence addressing the accuracy of routine screening by primary care providers for early detection of melanoma or nonmelanoma skin cancer ranged from poor to fair. We found no studies that assessed the effectiveness of periodic skin examination by a clinician in reducing melanoma mortality. Both self-assessment of risk factors or clinician examination can classify a small proportion of patients as at highest risk for melanoma. Skin cancer screening, perhaps using a risk-assessment technique to identify high-risk patients who are seeing a physician for other reasons, merits additional study as a strategy to address the excess burden of disease in older adults.
恶性黑色素瘤通常具有致命性,在过去20年中美国其发病率迅速上升。非黑色素瘤皮肤癌很少致命,但如果病情进展,可能导致严重毁容和发病。黑色素瘤的早期检测和治疗可能会降低死亡率,而非黑色素瘤皮肤癌的早期检测和治疗可能会预防严重毁容,并在较小程度上预防死亡。专业协会目前关于皮肤癌筛查的建议各不相同。
作为美国预防服务工作组评估的一部分,审查已发表的关于初级保健提供者进行皮肤癌常规筛查有效性的数据。
我们在MEDLINE数据库中搜索了1994年至1999年6月发表的论文,使用了筛查、体格检查、发病率和皮肤肿瘤的搜索词。对于筛查试验准确性的信息,我们使用了敏感性和特异性的搜索词。我们从《临床预防服务指南》第二版和高质量综述中确定了1994年以前最重要的研究。我们利用参考文献列表和专家建议来查找其他文章。
两名评审员独立评审了500篇摘要的一个子集。一旦建立了一致性,其余的由一名评审员评审。如果研究包含筛查产量、筛查试验、危险因素、风险评估、早期检测有效性或成本效益的数据,我们就将其纳入。
我们从已发表的关于筛查的全文研究中提取了以下描述性信息,并记录在电子数据库中:筛查研究类型、研究设计、环境、人群、患者招募、筛查试验描述、检查者、针对高危人群或非针对性的广告、参与者报告的危险因素以及转诊程序。我们还提取了筛查数据的产量,包括转诊的概率和数量、疑似皮肤癌的类型、活检、确诊的皮肤癌、皮肤癌的分期和厚度。对于报告了试验性能的研究,我们记录了可疑病变的定义、疾病的“金标准”判定以及真阳性、假阳性、真阴性和假阴性试验结果的数量。尽可能记录阳性预测值、似然比、敏感性和特异性。
尚未进行随机或病例对照研究来证明初级保健提供者对黑色素瘤进行常规筛查可降低发病率或死亡率。基底细胞癌和鳞状细胞癌非常常见,但在没有正式筛查的情况下进行检测和治疗几乎总是可以治愈的。没有对照研究表明正式的筛查计划会提高这种已经很高的治愈率。虽然筛查的有效性尚未确立,但筛查程序本身是非侵入性的,后续检查皮肤活检的发病率较低。来自大规模筛查计划的五项研究报告了皮肤检查作为筛查试验的准确性。其中一项前瞻性研究跟踪了结果为阴性的患者,以确定假阴性结果的患者数量。在这项研究中,皮肤癌筛查的敏感性为94%,特异性为98%。最近的几项病例对照研究证实了早期证据,即非典型痣和/或许多普通痣的存在会增加黑色素瘤的风险。一项精心完成的前瞻性研究表明,通过有限的体格检查进行风险评估可识别出相对较小(<10%)的一组初级保健患者进行更全面的评估。
关于初级保健提供者进行常规筛查以早期发现黑色素瘤或非黑色素瘤皮肤癌准确性的证据质量从差到中等。我们没有发现评估临床医生定期皮肤检查在降低黑色素瘤死亡率方面有效性的研究。对危险因素的自我评估或临床医生检查都可以将一小部分患者归类为黑色素瘤风险最高的人群。皮肤癌筛查,也许使用风险评估技术来识别因其他原因就诊的高危患者,作为一种应对老年人疾病负担过重的策略值得进一步研究。