O'Leary T J, Tellado M, Buckner S B, Ali I S, Stevens A, Ollayos C W
Department of Cellular Pathology, Armed Forces Institute of Pathology, Washington, DC 20306-6000, USA.
JAMA. 1998 Jan 21;279(3):235-7. doi: 10.1001/jama.279.3.235.
The Food and Drug Administration has recently approved several devices that use computerized image analysis to rescreen Papanicolaou (Pap) smears that have already been examined by cytotechnologists. Physicians and laboratories must decide whether the utility of these devices justifies the cost.
To determine the effectiveness and cost of PAPNET-assisted rescreening in identifying cervical abnormalities not identified by manual rescreening.
PAPNET-assisted rescreening of 5478 Pap smears obtained in 1994 and 1995 previously identified as "within normal limits" or "benign changes" on both initial and random screening.
Female service members and dependents aged 12 to 88 years.
Air Force clinics in the United States and Japan.
Rescreening of Pap smears by PAPNET, followed by reevaluation of abnormal smears by the consensus panel, consisting of 3 cytotechnologists and 3 pathologists.
Proportion of Pap smears initially screened as normal identified as abnormal by both PAPNET and consensus panel; costs of rescreening.
PAPNET screening identified 1614 (29%) slides requiring additional microscopic review. On further review, 448 (8% of total) had possibly abnormal cells. Ultimately, 11 of these cases were reviewed by the consensus panel for potentially atypical cells. Of these 11 cases, 5 were reclassified as atypical squamous cells of undetermined significance (ASCUS) and 1 as atypical glandular cells of undetermined significance (AGUS). No additional squamous intraepithelial neoplasia (SIL) was identified in these smears; the patient with a diagnosis of AGUS on rescreening was diagnosed as having a low-grade SIL (LSIL) on follow-up. Costs were $5825 to $33781 for each additional ASCUS or AGUS diagnosis. A cost of $17475 to $101343 is expected for each case of LSIL identified by PAPNET-assisted rescreening and not by traditional manual rescreening.
PAPNET-assisted rescreening identified a few more cases of ASCUS than did manual rescreening, but at a relatively high cost. The costs of rescreening should be carefully compared with the expected efficacy in reducing cervical cancer mortality.
美国食品药品监督管理局最近批准了几种使用计算机图像分析技术对已经由细胞技术专家检查过的巴氏涂片进行重新筛查的设备。医生和实验室必须决定这些设备的实用性是否能证明成本的合理性。
确定PAPNET辅助重新筛查在识别手工重新筛查未发现的宫颈异常方面的有效性和成本。
对1994年和1995年获得的5478份巴氏涂片进行PAPNET辅助重新筛查，这些涂片在初次筛查和随机筛查中均被判定为“正常范围”或“良性改变”。
年龄在12至88岁之间的女性军人及其家属。
美国和日本的空军诊所。
通过PAPNET对巴氏涂片进行重新筛查，然后由由3名细胞技术专家和3名病理学家组成的共识小组对异常涂片进行重新评估。
初次筛查为正常的巴氏涂片经PAPNET和共识小组均判定为异常的比例；重新筛查的成本。
PAPNET筛查确定1614份（29%）涂片需要进一步显微镜检查。进一步检查发现，448份（占总数的8%）有可能异常的细胞。最终，其中11例由共识小组对潜在的非典型细胞进行复查。在这11例中，5例重新分类为意义不明确的非典型鳞状细胞（ASCUS），1例为意义不明确的非典型腺细胞（AGUS）。这些涂片中未发现其他鳞状上皮内瘤变（SIL）；重新筛查诊断为AGUS的患者在随访中被诊断为低级别SIL（LSIL）。每增加一例ASCUS或AGUS诊断的成本为5825美元至33781美元。通过PAPNET辅助重新筛查而非传统手工重新筛查发现的每例LSIL病例的成本预计为17475美元至10134美元。
PAPNET辅助重新筛查发现的ASCUS病例比手工重新筛查略多，但成本相对较高。重新筛查的成本应与降低宫颈癌死亡率的预期疗效仔细比较。
