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Optimising recruitment to a lung cancer screening trial: A comparison of general practitioner and community-based recruitment. 优化肺癌筛查试验的招募工作:全科医生和社区招募的比较。
IF 2.9 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-03-01 Epub Date: 2023-08-01 DOI: 10.1177/09691413231190785
Hannah Scobie, Kathryn A Robb, Sara Macdonald, Stephen Harrow, Frank Sullivan

Objectives: Pre-trial focus groups of the Early detection of Cancer of the Lung Scotland (ECLS) trial indicated that those at high risk of lung cancer are more likely to engage with community-based recruitment methods. The current study aimed to understand if general practitioner (GP) and community-based recruitment might attract different groups of people, and to quantitatively explore the demographic and psychosocial differences between people responding to GP or community-based recruitment.

Design: Secondary data analysis of ECLS trial baseline data.

Methods: Adults (n = 11,164) aged 50 to 75 years completed a baseline questionnaire as part of their participation in the ECLS trial. The questionnaire assessed smoking behaviour, health state, health anxiety and illness perception. Alongside demographic characteristics, how participants were made aware of the study/participant recruitment method (GP recruitment/community recruitment) was also obtained via trial records.

Results: The likelihood of being recruited via community-based methods increased as deprivation level decreased. Those recruited via the community had higher levels of perceived personal control of developing lung cancer and were more likely to understand their own risk of developing lung cancer, compared to those who were recruited to the trial via their GP. Health state and health anxiety did not predict recruitment methods in multivariable analysis.

Conclusions: Community and opportunistic screening invitations were associated with uptake in people from less-deprived backgrounds, and therefore might not be the optimal method to reach those at high risk of lung cancer and living in more deprived areas.

目的:苏格兰肺癌早期检测(ECLS)试验的试验前焦点小组表明,肺癌高危人群更倾向于采用社区招募方法。本研究旨在了解全科医生(GP)和社区招募是否会吸引不同的人群,并定量探讨响应全科医生或社区招募的人群在人口统计学和社会心理方面的差异:设计:对 ECLS 试验基线数据进行二次数据分析:年龄在50至75岁之间的成年人(n = 11,164)在参与ECLS试验的过程中填写了一份基线问卷。问卷评估了吸烟行为、健康状况、健康焦虑和疾病认知。除了人口统计学特征外,还通过试验记录了解了参与者是如何知道这项研究的/参与者招募方法(全科医生招募/社区招募):结果:随着贫困程度的降低,通过社区招募的可能性也在增加。与通过全科医生招募参加试验的人相比,通过社区招募的人对罹患肺癌的个人控制感知水平更高,也更有可能了解自己罹患肺癌的风险。在多变量分析中,健康状况和健康焦虑并不能预测招募方式:结论:社区和机会性筛查邀请与贫困程度较低人群的接受率有关,因此可能不是接触肺癌高风险人群和贫困地区居民的最佳方法。
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引用次数: 0
Thank you to reviewers 感谢审稿人
IF 2.9 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2024-02-20 DOI: 10.1177/09691413241234013
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引用次数: 0
Cell-free DNA-based prenatal screening via rolling circle amplification: Identifying and resolving analytic issues. 通过滚动圈扩增的无细胞dna产前筛查:识别和解决分析问题。
IF 2.9 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-12-01 Epub Date: 2023-05-17 DOI: 10.1177/09691413231173315
Glenn E Palomaki, Geralyn M Lambert-Messerlian, Donna Fullerton, Madhuri Hegde, Stéphanie Conotte, Matthew L Saidel, Jacques C Jani

Objective: A rolling circle amplification (RCA) based commercial methodology using cell-free (cf)DNA to screen for common trisomies became available in 2018. Relevant publications documented high detection but with a higher than expected 1% false positive rate. Preliminary evidence suggested assay variability was an issue. A multi-center collaboration was created to explore this further and examine whether subsequent manufacturer changes were effective.

Methods: Three academic (four devices) and two commercial (two devices) laboratories provided run date, chromosome 21, 18, and 13 run-specific standard deviations, number of samples run, and reagent lot identifications. Temporal trends and between-site/device consistency were explored. Proportions of run standard deviations exceeding pre-specified caps of 0.4%, 0.4% and 0.6% were computed.

Results: Overall, 661 RCA runs between April 2019 and July 30, 2022 tested 39,756 samples. In the first 24, subsequent 9, and final 7 months, proportions of capped chromosome 21 runs dropped from 39% to 22% to 6.0%; for chromosome 18, rates were 76%, 36%, and 4.0%. Few chromosome 13 runs were capped using the original 0.60%, but capping at 0.50%, rates were 28%, 16%, and 7.6%. Final rates occurred after reformulated reagents and imaging software modifications were fully implemented across all devices. Revised detection and false positive rates are estimated at 98.4% and 0.3%, respectively. After repeat testing, failure rates may be as low as 0.3%.

Conclusion: Current RCA-based screening performance estimates are equivalent to those reported for other methods, but with a lower test failure rate after repeat testing.

目的:一种基于滚圈扩增(RCA)的商业方法,使用无细胞(cf)DNA筛查常见三体,于2018年问世。相关出版物记录了高检测率,但假阳性率高于预期的1%。初步证据表明,化验变异性是一个问题。创建了一个多中心合作来进一步探索这一点,并检查随后的制造商变更是否有效。方法:三个学术实验室(四个装置)和两个商业实验室(两个装置)提供了运行日期、21号、18号和13号染色体运行的具体标准偏差、运行的样品数量和试剂批次标识。探讨了时间趋势和站点/设备之间的一致性。计算了超过预先规定的0.4%、0.4%和0.6%上限的运行标准偏差比例。结果:总体而言,2019年4月至2022年7月30日期间,661次RCA测试了39756个样本。在前24个月、随后的9个月和最后7个月,21号染色体带帽运行的比例从39%降至22%,降至6.0%;对于18号染色体,发生率分别为76%、36%和4.0%。很少有13号染色体运行使用最初的0.60%进行封顶,但在0.50%时,发生率为28%、16%和7.6%。在所有设备上全面实施重新配制的试剂和成像软件修改后,才出现最终发生率。修正检测率和假阳性率估计分别为98.4%和0.3%。重复测试后,失败率可能低至0.3%。结论:目前基于RCA的筛查性能评估与其他方法的评估相当,但重复测试后的测试失败率较低。
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引用次数: 0
Differential impact of test performance characteristics on burden-to-benefit tradeoffs for blood-based colorectal cancer screening: A microsimulation analysis. 测试性能特征对血液结直肠癌筛查负担-收益权衡的差异影响:微观模拟分析。
IF 2.9 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-12-01 Epub Date: 2023-06-02 DOI: 10.1177/09691413231175056
Andrew Piscitello, Lauren N Carroll, Signe Fransen, Ben Wilson, Tarun Chandra, Reinier Meester, Girish Putcha

Objectives: To inform the development and evaluation of new blood-based colorectal cancer (CRC) screening tests satisfying minimum United States (US) coverage criteria, we estimated the impact of the different test performance characteristics on long-term testing benefits and burdens.

Methods: A novel CRC-Microsimulation of Adenoma Progression and Screening (CRC-MAPS) model was developed, validated, then used to assess different screening tests for CRC. We compared multiple, hypothetical blood-based CRC screening tests satisfying minimum coverage criteria of 74% CRC sensitivity and 90% specificity, to measure how changes in a test's CRC sensitivity, specificity, and adenoma sensitivity (sizes 1-5 mm, 6-9 mm, ≥10 mm) affect total number of colonoscopies (COL), CRC incidence reduction (IR), CRC mortality reduction (MR), and burden-to-benefit ratios (incremental COLs per percentage-point increase in IR or MR).

Results: A blood test meeting minimum US coverage criteria for performance characteristics resulted in 1576 lifetime COLs per 1000 individuals, 46.7% IR and 59.2% MR compared to no screening. Tests with increased CRC sensitivity of 99% ( + 25%) vs. increased ≥10 mm adenoma sensitivity of 13.6% ( + 3.6%) both yielded the same MR, 62.7%. Test benefits improved the most with increases in all-size adenoma sensitivity, then size-specific adenoma sensitivities, then specificity and CRC sensitivity, while increases in specificity or ≥10 mm adenoma sensitivity resulted in the most favorable burden-to-benefit tradeoffs (ratios <11.5).

Conclusions: Burden-to-benefit ratios for blood-based CRC screening tests differ by performance characteristic, with the most favorable tradeoffs resulting from improvements in specificity and ≥10 mm adenoma sensitivity.

目的:为了了解符合美国最低覆盖率标准的新的基于血液的癌症(CRC)筛查测试的开发和评估,我们估计了不同测试性能特征对长期测试收益和负担的影响。方法:建立一种新的CRC微刺激腺瘤进展和筛查(CRC-MAS)模型,进行验证,然后用于评估不同的CRC筛查试验。我们比较了多个假设的基于血液的CRC筛查测试,这些测试满足74%CRC敏感性和90%特异性的最低覆盖标准,以测量测试的CRC敏感性、特异性和腺瘤敏感性(大小1-5 毫米,6-9 mm,≥10 mm)影响结肠镜检查总数(COL)、CRC发病率降低(IR)、CRC死亡率降低(MR)和负担效益比(IR或MR每增加一个百分点的COL增量)。CRC灵敏度提高99%的测试( + 25%)与增加≥10 mm腺瘤的敏感性为13.6%( + 3.6%)两者产生相同的MR,为62.7%。随着所有大小腺瘤敏感性的增加,然后是大小特异性腺瘤敏感性的提高,然后是特异性和CRC敏感性的提高。而特异性或≥10 mm腺瘤的敏感性导致了最有利的负担效益权衡(比率结论:基于血液的CRC筛查测试的负担效益比率因性能特征而异,最有利的权衡来自特异性的提高和≥10 mm腺瘤敏感性。
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引用次数: 0
Risk of cancer versus risk of cancer diagnosis? Accounting for diagnostic bias in predictions of breast cancer risk by race and ethnicity. 癌症风险vs癌症诊断风险?根据种族和民族预测乳腺癌风险的诊断偏差。
IF 2.6 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-12-01 Epub Date: 2023-06-12 DOI: 10.1177/09691413231180028
Charlotte C Gard, Jane Lange, Diana L Miglioretti, Ellen S O'Meara, Christoph I Lee, Ruth Etzioni

Objectives: Cancer risk prediction may be subject to detection bias if utilization of screening is related to cancer risk factors. We examine detection bias when predicting breast cancer risk by race/ethnicity.

Methods: We used screening and diagnosis histories from the Breast Cancer Surveillance Consortium to estimate risk of breast cancer onset and calculated relative risk of onset and diagnosis for each racial/ethnic group compared with non-Hispanic White women.

Results: Of 104,073 women aged 40-54 receiving their first screening mammogram at a Breast Cancer Surveillance Consortium facility between 2000 and 2018, 10.2% (n = 10,634) identified as Asian, 10.9% (n = 11,292) as Hispanic, and 8.4% (n = 8719) as non-Hispanic Black. Hispanic and non-Hispanic Black women had slightly lower screening frequencies but biopsy rates following a positive mammogram were similar across groups. Risk of cancer diagnosis was similar for non-Hispanic Black and White women (relative risk vs non-Hispanic White = 0.90, 95% CI 0.65 to 1.14) but was lower for Asian (relative risk = 0.70, 95% CI 0.56 to 0.97) and Hispanic women (relative risk = 0.82, 95% CI 0.62 to 1.08). Relative risks of disease onset were 0.78 (95% CI 0.68 to 0.88), 0.70 (95% CI 0.59 to 0.83), and 0.95 (95% CI 0.84 to 1.09) for Asian, Hispanic, and non-Hispanic Black women, respectively.

Conclusions: Racial/ethnic differences in mammography and biopsy utilization did not induce substantial detection bias; relative risks of disease onset were similar to or modestly different than relative risks of diagnosis. Asian and Hispanic women have lower risks of developing breast cancer than non-Hispanic Black and White women, who have similar risks.

目的:如果筛查的使用与癌症危险因素有关,癌症风险预测可能会受到检测偏差的影响。我们在按种族/民族预测乳腺癌症风险时检查检测偏差。方法:我们使用癌症监测联合会的筛查和诊断历史来估计癌症发病的风险,并计算每个种族/民族与非西班牙裔白人女性相比的发病和诊断的相对风险。结果:2000年至2018年间,104073名40-54岁的女性在癌症监测联盟机构接受了首次筛查乳房X光检查,10.2%(n = 10634)被鉴定为亚洲人,10.9%(n = 11292)为西班牙裔,8.4%(n = 8719)为非西班牙裔黑人。拉美裔和非拉美裔黑人女性的筛查频率略低,但乳腺X光检查呈阳性后的活检率在各组之间相似。非西班牙裔黑人和白人女性患癌症的风险相似(相对风险与非西班牙裔白人相比 = 0.90,95%CI 0.65至1.14),但亚洲人的风险较低(相对风险 = 0.70,95%CI 0.56至0.97)和西班牙裔女性(相对风险 = 亚洲、西班牙裔和非西班牙籍黑人女性的发病相对风险分别为0.78(95%CI 0.68至0.88)、0.70(95%CI 0.59至0.83)和0.95(95%CI 0.84至1.09)。结论:乳腺钼靶摄影和活检利用率的种族/民族差异没有引起实质性的检测偏差;发病的相对风险与诊断的相对风险相似或略有不同。亚裔和西班牙裔女性患癌症的风险低于非西班牙族黑人和白人女性,后者的风险相似。
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引用次数: 0
Long-term cause of death patterns and mode of breast cancer detection in The Netherlands, 2004-2019. 2004 - 2019年荷兰乳腺癌的长期死因模式和检测方式
IF 2.9 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-12-01 Epub Date: 2023-06-26 DOI: 10.1177/09691413231183528
Johannes D M Otten, André L M Verbeek, Mireille J M Broeders

Objective: Early detection through mammographic screening and various treatment modalities of cancer may have changed life expectancy and cause-specific mortality of breast cancer patients. We aimed to determine the long-term cause of death patterns in screening-detected patients and clinically diagnosed patients in the Netherlands compared with the general population.

Methods: Using data from the Netherlands Cancer Registry and Statistics Netherlands of around 26,000 women, aged 50-75 at diagnosis and surgically treated for invasive breast cancer in 2004-2008, we compared patients with screening-detected and clinically diagnosed cancer for major causes of death until 2020. The expected number of all-cause and cause-specific deaths was calculated using rates of the general population.

Results: During the follow-up period, 4310 women died. The age-standardised all-cause mortality ratio for the screening-detected cancer group was 1.41 (95% confidence interval (95% CI), 1.37-1.46). A higher mortality ratio was observed for patients with clinically detected cancer: 2.27 (95% CI, 2.19-2.34). The observed versus expected breast cancer mortality ratio in the screening-detected patient group was 8.92 (95% CI, 8.45-9.40) and 20.23 (19.38-21.09) in the clinical group. Excess mortality was found for lung cancer in both patient groups, and small elevations for circulatory and respiratory disease in the clinically detected group.

Conclusion: Our results indicate that for the screening group no other causes of death but breast and lung cancer were prominent compared with the general population. The clinical group showed excess mortality for some other causes of death as well, suggesting a less healthy group compared with the general population.

通过乳房x线摄影筛查和各种癌症治疗方式的早期发现可能改变了乳腺癌患者的预期寿命和病因特异性死亡率。我们的目的是确定荷兰筛查检测患者和临床诊断患者与一般人群相比的长期死亡原因模式。使用来自荷兰癌症登记处和荷兰统计的数据,在2004-2008年期间,约有26,000名年龄在50-75岁之间的浸润性乳腺癌诊断和手术治疗的妇女,我们比较了筛查检测到的癌症和临床诊断的癌症患者到2020年的主要死亡原因。使用一般人群的死亡率计算全因和特定原因死亡的预期人数。在随访期间,有4310名妇女死亡。筛查发现的癌症组的年龄标准化全因死亡率为1.41(95%可信区间(95% CI), 1.37-1.46)。临床检测出癌症的患者死亡率较高:2.27 (95% CI, 2.19-2.34)。在筛查检测患者组中,观察到的乳腺癌死亡率与预期的乳腺癌死亡率相比,临床组为8.92 (95% CI, 8.45-9.40)和20.23(19.38-21.09)。在两组患者中均发现肺癌死亡率过高,而在临床检测组中循环系统和呼吸系统疾病死亡率小幅升高。我们的结果表明,与一般人群相比,筛查组除了乳腺癌和肺癌外,没有其他死因。临床组在其他死因上的死亡率也较高,这表明与一般人群相比,临床组的健康状况较差。
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引用次数: 0
Improved use of faecal immunochemical tests for haemoglobin in the Scottish bowel screening programme. 改进使用粪便免疫化学测试血红蛋白在苏格兰肠筛查方案。
IF 2.9 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-12-01 Epub Date: 2023-05-25 DOI: 10.1177/09691413231175611
Jayne Digby, Callum G Fraser, Gavin Clark, Craig Mowat, Judith A Strachan, Robert Jc Steele

Objectives: This study aimed to develop a risk-scoring model in the Scottish Bowel Screening Programme incorporating faecal haemoglobin concentration with other risk factors for colorectal cancer.

Methods: Data were collected for all individuals invited to participate in the Scottish Bowel Screening Programme between November 2017 and March 2018 including faecal haemoglobin concentration, age, sex, National Health Service Board, socioeconomic status, and screening history. Linkage with The Scottish Cancer Registry identified all screening participants diagnosed with colorectal cancer. Logistic regression was performed to identify which factors demonstrated significant association with colorectal cancer and could be used in the development of a risk-scoring model.

Results: Of 232,076 screening participants, 427 had colorectal cancer: 286 diagnosed following a screening colonoscopy and 141 arising after a negative screening test result giving an interval cancer proportion of 33.0%. Only faecal haemoglobin concentration and age showed a statistically significant association with colorectal cancer. Interval cancer proportion increased with age and was higher in women (38.1%) than men (27.5%). If positivity in women were mirrored in men at each age quintile interval cancer proportion would still have remained higher in women (33.2%). Moreover, an additional 1201 colonoscopies would be required to detect 11 colorectal cancers.

Conclusions: Development of a risk scoring model using early data from the Scottish Bowel Screening Programme was not feasible due to most variables showing insignificant association with colorectal cancer. Tailoring the faecal haemoglobin concentration threshold according to age could help to diminish some of the disparity in interval cancer proportion between women and men. Strategies to achieve sex equality using faecal haemoglobin concentration thresholds depend considerably on which variable is selected for equivalency and this requires further exploration.

目的:本研究旨在开发苏格兰肠道筛查计划中的风险分级模型,将粪便血红蛋白浓度与其他癌症风险因素结合起来。方法:收集2017年11月至2018年3月期间受邀参加苏格兰肠道筛查计划的所有个人的数据,包括粪便血红蛋白浓度、年龄、性别、国家卫生服务委员会、社会经济地位和筛查史。与苏格兰癌症登记处的联系确定了所有被诊断为癌症的筛查参与者。进行逻辑回归以确定哪些因素与癌症显著相关,并可用于风险分级模型的开发。结果:在232076名筛查参与者中,427人患有癌症:286人在筛查结肠镜检查后被诊断为结直肠癌,141人在筛查结果呈阴性后出现,间隔癌症的比例为33.0%。只有粪便血红蛋白浓度和年龄与癌症有统计学显著关联。区间癌症的比例随着年龄的增长而增加,女性(38.1%)高于男性(27.5%)。如果女性的阳性率反映在每个年龄五分之一区间的男性中,癌症的比例在女性中仍然更高(33.2%)。此外,需要额外1201次结肠镜检查才能检测11例结直肠癌。结论:使用苏格兰肠道筛查计划的早期数据开发风险评分模型是不可行的,因为大多数变量显示与癌症无关。根据年龄定制粪便血红蛋白浓度阈值可能有助于缩小男女之间癌症间隔比例的差异。使用粪便血红蛋白浓度阈值实现性别平等的策略在很大程度上取决于选择哪个变量进行等效,这需要进一步探索。
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引用次数: 0
Outcome of premarital genetic counseling for couples at risk of hemoglobinopathies in Kingdom of Bahrain. 巴林王国对有血红蛋白病风险的夫妇进行婚前遗传咨询的结果。
IF 2.9 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-12-01 Epub Date: 2023-04-17 DOI: 10.1177/09691413231169820
Samya Bahram, Aalaa Haji, Hawra Abdulwahab, Hanan Mohsen, Tahera Alnashaba, Zainab Al-Aradi, Mohamed Mandeel

Objectives: Hemoglobinopathies are the commonest inherited blood disorders and form a serious burden worldwide, affecting communities, patient quality of life and healthcare resources. The Kingdom of Bahrain has issued a law obligating couples to undergo premarital screening to detect those at risk of having children affected with these disorders. The aim of this study was to analyze the marital decisions of couples at risk for hemoglobinopathies and follow up the outcomes.

Methods: A retrospective study was conducted on couples at risk for hemoglobinopathies identified during the premarital screening program at local health centers in the Kingdom of Bahrain and referred to the genetics department in the Salmaniya Medical Complex for genetic counselling in 2018-2020.

Results: A total of 189 couples were found to be at risk for hemoglobinopathies, of whom 159 completed the survey. Of these, 107 (67%) decided to proceed with their marriage and 26 couples achieved pregnancy. Out of 24 at-risk pregnancies with known outcome, 83.3% were spontaneous whereas only 16.7% underwent in-vitro fertilization (IVF) with preimplantation genetic diagnosis (PGD). Eight out of 20 infants born to couples after spontaneous conception were affected. A positive attitude toward IVF with PGD was held by 60% of at-risk couples.

Conclusions: Despite undergoing premarital screening and genetic counselling, a large percentage of at-risk couples proceeded with their marriage. Most of them justified their decision due to the availability of advanced methods that aid in the prevention of having an affected child. However, the cost of such intervention was a major barrier for the majority of couples.

目的:血红蛋白病是最常见的遗传性血液病,在全球范围内构成严重负担,影响社区、患者生活质量和医疗资源。巴林王国颁布了一项法律,要求夫妇必须接受婚前筛查,以发现那些有可能生下患有这些疾病的孩子的人。本研究的目的是分析有血红蛋白病风险的夫妇的婚姻决定并跟踪结果。方法:对巴林王国当地卫生中心婚前筛查项目中发现的有血红蛋白病风险的夫妇进行了一项回顾性研究,并于2018-2020年将其转介至萨尔马尼亚医疗中心的遗传学部门进行遗传咨询。结果:共发现189对夫妇有血红蛋白病的风险,其中159人完成了调查。其中,107对(67%)夫妇决定继续结婚,26对夫妇怀孕。在24例已知结局的高危妊娠中,83.3%是自发妊娠,而只有16.7%接受了植入前基因诊断(PGD)的体外受精(IVF)。夫妇自然受孕后所生的20个婴儿中有8个受到影响。60%的高危夫妇对PGD试管婴儿持积极态度。结论:尽管接受了婚前筛查和基因咨询,但仍有很大比例的高危夫妇继续他们的婚姻。他们中的大多数人都证明了自己的决定是合理的,因为有先进的方法可以帮助预防受影响的孩子。然而,这种干预的成本对大多数夫妇来说是一个主要障碍。
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引用次数: 0
Combining genetic and non-genetic risk factors to predict disease, and reporting the screening performance of risk models. 结合遗传和非遗传风险因素预测疾病,并报告风险模型的筛查效果。
IF 2.9 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-12-01 Epub Date: 2023-08-24 DOI: 10.1177/09691413231196124
Robert Old
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引用次数: 0
The 5-year risk of recurrence of grade 2/3 cervical intraepithelial neoplasia after treatment in a population screening programme by human papillomavirus status: A cohort study in central Italy. 人乳头瘤病毒状态人群筛查方案治疗后2/3级宫颈上皮内瘤变复发的5年风险:意大利中部的一项队列研究
IF 2.9 4区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-12-01 Epub Date: 2023-05-25 DOI: 10.1177/09691413231175630
Carmen Beatriz Visioli, Anna Iossa, Giuseppe Gorini, Paola Mantellini, Lisa Lelli, Noemi Auzzi, Carmelina Di Pierro, Francesca Maria Carozzi, Marco Zappa

Objectives: (a) To estimate the risk of recurrent cervical intraepithelial neoplasia, grade 2/3 or worse (CIN2+/CIN3+), lesions within 5 years of follow-up in human papillomavirus-negative/human papillomavirus-positive cohorts; (b) to assess whether certain risk factors can predict the recurrence of CIN2+/CIN3+ lesions; and (c) to provide recommendations for follow-up after treatment of cervical intraepithelial neoplasia, grade 2/3 to prevent cervical cancer.

Setting: Organized cervical cancer screening programme in Central Italy.

Methods: We included 1063 consecutive first excisional treatments performed between 2006 and 2014 for screening-detected cervical intraepithelial neoplasia, grade 2/3 lesions among women aged 25-65. The study population was divided into two groups according to the human papillomavirus test results performed 6 months after treatment: Human papillomavirus-negative and human papillomavirus-positive cohorts. The 5-year risk of developing cervical intraepithelial neoplasia, grade 2/3 or worse (CIN2+/CIN3+) was estimated using the Kaplan-Meier method and the Cox regression model.

Results: Among 829 human papillomavirus-negative and 234 human papillomavirus-positive women, six (0.72%; three cervical intraepithelial neoplasia, grade 2, three cervical intraepithelial neoplasia, grade 3) and 45 (19.2%; 15 cervical intraepithelial neoplasia, grade 2, 30 cervical intraepithelial neoplasia, grade 3), respectively, developed CIN2+ recurrence within 5 years of follow-up. The cumulative risks for CIN2+ and CIN3+ were 0.9% (95% confidence interval: 0.4%-2.0%) and 0.5% (95% confidence interval: 0.1%-1.4%), respectively, for the human papillomavirus-negative cohort, and 24.8% (95% confidence interval: 18.5%-32.7%) and 16.9% (95% confidence interval: 11.4%-24.5%), respectively, for the human papillomavirus-positive cohort. Risk factors associated with increased risk of recurrence were both margins positive for the human papillomavirus-negative cohort, and positive margins, cervical intraepithelial neoplasia, grade 3 lesions, high-grade cytology and high viral load for the human papillomavirus-positive cohort.

Conclusions: Human papillomavirus testing can identify women at increased risk of recurrence and this supports a recommendation for its use in the post-treatment follow-up of cervical intraepithelial neoplasia, grade 2/3 lesions.

目的:(a)在人乳头瘤病毒阴性/人乳头瘤细胞阳性队列中,评估随访5年内复发性宫颈上皮内瘤变(2/3级或更糟(CIN2+/CIN3+)、病变的风险;(b) 评估某些危险因素是否可以预测CIN2+/CIN3+病变的复发;和(c)为宫颈上皮内瘤变2/3级治疗后的随访提供建议,以预防宫颈癌症。背景:在意大利中部组织宫颈癌症筛查计划。方法:我们纳入了2006年至2014年间连续进行的1063次首次切除治疗,用于筛查25-65岁女性中检测到的宫颈上皮内瘤变,2/3级病变。根据治疗后6个月进行的人乳头瘤病毒检测结果,将研究人群分为两组:人乳头状瘤病毒阴性和人乳头状病毒阳性队列。使用Kaplan-Meier方法和Cox回归模型估计了发生宫颈上皮内瘤变(2/3级或更糟)(CIN2+/CIN3+)的5年风险。结果:在829例人乳头瘤病毒阴性和234例人乳头状瘤病毒阳性女性中,6例(0.72%;3例宫颈上皮内瘤变,2级,3例宫颈癌上皮内瘤样变,3级)和45例(19.2%;15例宫颈癌细胞内瘤样病变,2级和30例宫颈癌组织内瘤样瘤样变3级)在随访5年内分别出现CIN2+复发。对于人乳头瘤病毒阴性队列,CIN2+和CIN3+的累积风险分别为0.9%(95%置信区间:0.4%-2.0%)和0.5%(95%可信区间:0.1%-1.4%。与复发风险增加相关的风险因素包括人乳头瘤病毒阴性队列的切缘阳性,以及人乳头状瘤病毒阳性队列的阳性切缘、宫颈上皮内瘤变、3级病变、高级细胞学和高病毒载量。结论:人乳头瘤病毒检测可以识别复发风险增加的女性,这支持将其用于宫颈上皮内瘤变2/3级病变的治疗后随访的建议。
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Journal of Medical Screening
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