Katayoun Taghavi, Misinzo Moono, Mulindi Mwanahamuntu, Marie Roumet, Andreas Limacher, Herbert Kapesa, Thamsanqa Madliwa, Anne Rutjes, Partha Basu, Nicola Low, Albert Manasyan, Julia Bohlius
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The index tests were high-risk human papillomavirus detection (hrHPV, Xpert HPV, Cepheid), portable colposcopy (Gynocular, Gynius) and visual inspection with acetic acid (VIA). Accuracy of stand-alone and test combinations were calculated as the point estimate with 95% CIs. A sensitivity analysis considered disease when only visible lesions were biopsied.</p><p><strong>Results: </strong>Women included in the study had well-controlled HIV infection (median CD4 count=542 cells/mm<sup>3</sup>) and all except one were on antiretroviral therapy. Among 371 participants with histopathological results, 27% (101/371) women had CIN2+ and 23% (23/101) were not detected by any index test. Sensitivity and specificity for stand-alone tests were: hrHPV, 67.3% (95% CI 57.7% to 75.7%) and 65.3% (95% CI 59.4% to 70.7%); Gynocular 51.5% (95% CI 41.9% to 61.0%) and 80.0% (95% CI 74.8% to 84.3%); and VIA 22.8% (95% CI 15.7% to 31.9%) and 92.6% (95% CI 88.8% to 95.2%), respectively. Combining tests did not improve test accuracy measures. All test accuracies improved in sensitivity analysis.</p><p><strong>Conclusion: </strong>The low accuracy of screening tests assessed might be explained by our reference standard, which reduced verification and misclassification biases. Better screening strategies for WLHIV in low-resource settings are urgently needed.</p><p><strong>Trial registration number: </strong>NCT03931083.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"3 1","pages":"e000111"},"PeriodicalIF":0.0000,"publicationDate":"2024-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11235020/pdf/","citationCount":"0","resultStr":"{\"title\":\"Accuracy of screening tests for cervical precancer in women living with HIV in low-resource settings: a paired prospective study in Lusaka, Zambia.\",\"authors\":\"Katayoun Taghavi, Misinzo Moono, Mulindi Mwanahamuntu, Marie Roumet, Andreas Limacher, Herbert Kapesa, Thamsanqa Madliwa, Anne Rutjes, Partha Basu, Nicola Low, Albert Manasyan, Julia Bohlius\",\"doi\":\"10.1136/bmjonc-2023-000111\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This study aimed to provide evidence to improve cervical screening for women living with HIV (WLHIV). 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A sensitivity analysis considered disease when only visible lesions were biopsied.</p><p><strong>Results: </strong>Women included in the study had well-controlled HIV infection (median CD4 count=542 cells/mm<sup>3</sup>) and all except one were on antiretroviral therapy. Among 371 participants with histopathological results, 27% (101/371) women had CIN2+ and 23% (23/101) were not detected by any index test. Sensitivity and specificity for stand-alone tests were: hrHPV, 67.3% (95% CI 57.7% to 75.7%) and 65.3% (95% CI 59.4% to 70.7%); Gynocular 51.5% (95% CI 41.9% to 61.0%) and 80.0% (95% CI 74.8% to 84.3%); and VIA 22.8% (95% CI 15.7% to 31.9%) and 92.6% (95% CI 88.8% to 95.2%), respectively. Combining tests did not improve test accuracy measures. All test accuracies improved in sensitivity analysis.</p><p><strong>Conclusion: </strong>The low accuracy of screening tests assessed might be explained by our reference standard, which reduced verification and misclassification biases. 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引用次数: 0
摘要
目的：本研究旨在为改善女性HIV感染者子宫颈筛查提供依据。我们评估了可用于低资源环境的筛选试验的准确性，并在同一次就诊时给出结果。方法和分析：我们对在赞比亚卢萨卡一家医院接受宫颈癌筛查的18-65岁连续符合条件的WLHIV患者进行了配对前瞻性研究。组织病理学参考标准是在两个时间点进行多次活检。目标条件为宫颈上皮内瘤变2级及以上（CIN2+）。指标检测为高危人乳头瘤病毒检测（hrHPV、Xpert HPV、Cepheid）、便携式阴道镜检查（Gynocular、Gynius）和醋酸目视检查（VIA）。单独和试验组合的准确性以95% ci的点估计值计算。当仅活检可见病变时，敏感性分析考虑疾病。结果：研究中包括的妇女的HIV感染得到了很好的控制（中位数CD4计数=542细胞/mm3），除一人外，所有妇女都接受了抗逆转录病毒治疗。在371名有组织病理学结果的参与者中，27%（101/371）的女性为CIN2+， 23%（23/101）的女性未通过任何指标测试检测到。独立检测的敏感性和特异性分别为：hrHPV， 67.3% （95% CI 57.7% ~ 75.7%）和65.3% (95% CI 59.4% ~ 70.7%)；妇科51.5% （95% CI 41.9% ~ 61.0%）和80.0% (95% CI 74.8% ~ 84.3%)；VIA分别为22.8% （95% CI 15.7% ~ 31.9%）和92.6% （95% CI 88.8% ~ 95.2%）。组合测试并没有提高测试的准确性。在灵敏度分析中，所有测试的准确性都得到了提高。结论：筛选试验的准确性较低，可以用我们的参考标准来解释，减少了验证和误分类偏差。在资源匮乏的环境中，迫切需要更好的艾滋病毒筛查策略。试验注册号：NCT03931083。
Accuracy of screening tests for cervical precancer in women living with HIV in low-resource settings: a paired prospective study in Lusaka, Zambia.
Objective: This study aimed to provide evidence to improve cervical screening for women living with HIV (WLHIV). We assessed the accuracy of screening tests that can be used in low-resource settings and give results at the same visit.
Methods and analysis: We conducted a paired, prospective study among consecutive eligible WLHIV, aged 18-65 years, receiving cervical cancer screening at one hospital in Lusaka, Zambia. The histopathological reference standard was multiple biopsies taken at two time points. The target condition was cervical intraepithelial neoplasia grade 2 and above (CIN2+). The index tests were high-risk human papillomavirus detection (hrHPV, Xpert HPV, Cepheid), portable colposcopy (Gynocular, Gynius) and visual inspection with acetic acid (VIA). Accuracy of stand-alone and test combinations were calculated as the point estimate with 95% CIs. A sensitivity analysis considered disease when only visible lesions were biopsied.
Results: Women included in the study had well-controlled HIV infection (median CD4 count=542 cells/mm3) and all except one were on antiretroviral therapy. Among 371 participants with histopathological results, 27% (101/371) women had CIN2+ and 23% (23/101) were not detected by any index test. Sensitivity and specificity for stand-alone tests were: hrHPV, 67.3% (95% CI 57.7% to 75.7%) and 65.3% (95% CI 59.4% to 70.7%); Gynocular 51.5% (95% CI 41.9% to 61.0%) and 80.0% (95% CI 74.8% to 84.3%); and VIA 22.8% (95% CI 15.7% to 31.9%) and 92.6% (95% CI 88.8% to 95.2%), respectively. Combining tests did not improve test accuracy measures. All test accuracies improved in sensitivity analysis.
Conclusion: The low accuracy of screening tests assessed might be explained by our reference standard, which reduced verification and misclassification biases. Better screening strategies for WLHIV in low-resource settings are urgently needed.
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