基于杭州城市社区自然人群大肠癌筛查
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摘要
【目的和意义】
应用本单位先前基于中小城市农村建立的大肠癌筛查方法首次在城市社区(杭州市下城区)自然人群开展筛查实践,进一步评价及验证该方案对城市人群的筛查效果,发现并设计方案解决筛查中可能遇到的顺应性低、特异度不理想等问题,提出今后大肠癌筛查的发展方向,并探索血清学大肠癌筛查方法并评价其效果,期望为我国大肠癌筛查方案的进一步完善,提供理论和实践依据。
【研究内容】
①评价方案对城市社区自然人群的筛查效果。分析免疫法粪便潜血(iFOBT)和问卷调查结合后筛查效果。分析方案中各高危因素项目对筛查方案的作用。首次对高危因素各项目依敏感度及特异度进行排序。②通过城市与农村自然人群筛查受检率的比较,发现目前城市自然人群大肠癌筛查所遇到的受检率较低问题,为今后城市社区自然人群大肠癌筛查的具体实施提供了决策依据。③对现场筛查发现的问题如顺应性、特异度不理想等问题探索解决方案。④评价以减少顾虑、提高高危人群肠镜受检率为目地干预措施,以提高高危人群肠镜受检率。⑤以血清癌胚抗原(CEA)为参照,探索血清M2型丙酮酸激酶(M2-PK)在大肠癌筛查中的应用价值。⑥应用表面增强激光解析电离-飞行时间-质谱(SELDI-TOF-MS)技术建立高危人群腺瘤vs正常、非腺瘤性息肉vs正常、腺瘤vs非腺瘤性息肉的血清蛋白质质谱的诊断预测模型,评价预测模型在筛查中的应用前景。⑦评价血清M2型丙酮酸激酶(M2-PK)与血清蛋白质质谱的诊断预测模型联合检测的应用价值。
【研究方法】
第一部分对杭州市下城区自然人群大肠癌筛查研究①大肠癌筛查方案应用于城市社区后的筛查效果。主要指标:早诊率;癌及癌前病变检出率;初筛与精筛人群受检率;iFOBT及问卷调查的阳性率;iFOBT及问卷调查的阳性预测值;iFOBT及问卷阳性的敏感度、特异度。②iFOBT及高危因素问卷调查在筛查中的意义:主要指标:iFOBT及问卷调查分别对癌及癌前病变的检出数量及比例。③对高危因素各项目的分析:各高危因素诊断癌及癌前病变的敏感度及特异度。④检出的大肠癌、腺瘤、非腺瘤性息肉的部位分布。主要指标:病变在结肠左半(直肠、乙状结肠、降结肠)、横结肠、结肠右半(回盲部、升结肠)的分布数量及比例。⑤与海宁、嘉善农村大肠癌筛查比较。主要指标:检出率;早诊率;受检率;早期大肠癌所占的比例。第二部分对城市社区肠镜拒检高危人群的再干预通过设计问卷调查明确影响肠镜受检率的主要原因,设计以“降低顾虑,提高肠镜受检率”为目标的干预方案,采取针对性的干预措施。评价干预效果。指标:影响肠镜受检率的原因构成比;干预前后肠镜受检率的变化。应用Logistic回归分析,确定干预效果相关因素。第三部分探索血清学大肠癌的筛查方法,评价血清M2-PK和血清蛋白质谱模型对大肠癌及癌前病变的筛查效果。评价两者结合对腺瘤及非腺瘤性息肉的筛查效果。评价血清M2-PK的方法:ROC曲线,曲线下面积;敏感度;特异度。评价血清蛋白质谱模型的方法:模型训练;模型10倍交叉验证。评价两者结合方法:联合后敏感度及特异度。
【创新点与结论】
通过对下城区大肠癌筛查的研究①首次证明来自于中小城市农村的大肠癌筛查方案对城市社区自然人群与中小城市农村的自然人群一样具有较好的检出效果,证明了问卷调查对大肠癌筛查的重要作用,能弥补iFOBT不足,发现其不能检出的包括不出血病变,尤其是腺瘤、息肉;②首次在城市社区自然人群中对各高危项目根据诊断的敏感度及特异度进行了排序。验证了中国特有的高危项目在大肠癌筛查方案中起重要的作用。③发现城市社区筛查过程中存在的一些需要解决的问题,比如初筛和精筛的受检率较低的问题,开展以自然人群为基础的大肠癌筛查难度较农村更大,初筛须进一步加强基于社区的宣传与发动,精筛须采取以医院或有条件的内镜中心为主的“医院筛查模式”。④为提高高危人群肠镜受检率,首次开展对肠镜拒检人群的干预工作。研究建立了以社区宣传、发动动员高危人群行肠镜检查,然后对拒检高危人群实行以“减少顾虑、提高肠镜受检率为目标”的干预方案,并取得了较好的干预效果。⑤评价了血清学大肠癌筛查的方法,提示血清学筛查方法可有效的浓缩高危人群,对高危人群进行再一次风险评估和预警,提高大肠癌筛查的敏感度或特异度。
【Objective and Sense】
CRC Screening practice was carried out for the first time among natural population in Hangzhou city based on CRC screening guide line established previously in rural area of small and medium-sized cities.Screening effect of the guideline on city population will be evaluated.The program has been designed to solve the problem met in screening practice,such as the low uptake and specificity,etc.Serum CRC screening methods were explored and their effects evaluated in order to perfect the China CRC screening guideline and provide theory and practice basis for it.
【Content】
①The study is to evaluate the screening effectiveness among natural population in city area,analyse the screening effects of combination of iFOBT and questionnaire and show the function of each high risk factors in the screening guideline.Each high risk factor was sorted for the first time according to its sensitivity and specificity.②The problem of low uptake rate was met in the process of screening practice among city natural population.It will provide the basis of decision-making for screening practice among city natural population in the future.③Resolution was designed to the problems met in the process of screening,such as low uptake rate and specificity.④The study is to evaluate barrier focused intervention to increase the colonoscopy adherence among high-risk population.⑤Using serum CEA as reference,the study is to evaluate the application value of serum M2-PK in CRC screening.⑥Diagnosis and predictive model was established by SELDI-TOF-MS in high-risk population.The study is to evaluate the application prospects of this model in CRC screening.⑦The study is to evaluate the application value of combination of serum M2-PK and serum protein profiles model.
【Methods】
Part One:Study on CRC screening among natural population in Xiacheng district, Hangzhou.①The screening effect among natural population in city.Main indicators: Early diagnosis rate;The detection rates of cancer and precancerous lesions;Uptake rates of iFOBT and questionnaire in primary and secondary screening;Positivity rates of iFOBT and questionnaire.Positive predictive value(PPV);Sensitivity and specificity of iFOBT and questionnaire;②The functions of iFOBT and questionnaire in screening. Main indicators:Detection number and ratio of cancer or precancerous lesions.③Analysis of high risk factors.Sensitivity and specificity of high risk factors to cancer and precancerous lesions.④Location distribution of cancer,adenomas,nonpolyposis. Main indicators:The number and ratio of lesions located in left colon(rectum,sigmoid, decending colon),transverse colon,right colon(ileocecal junction,ascending colon). City screening effect in urban area was compared with that in rural aera.Main indicators:The detection rate;Early detection rate;Uptake rate;rate of early colorectal cancer.Part Two Barrier-focused intervention to Nonadherent high risk population in city CRC screening Questionnaire investigation was designed to identify the main reasons of nonadherece by telephone interview with nonadherent subjects.Barrier focused interventions were designed and were carried out accoding to reasons. Intervention effects was evaluated.Main indicators:The ratio of main barriers to colonoscopy among nonadherence high-risk subjects;The change of colonoscopy adherence rate between pre and post intervention.Factors related to intervention effect was determined by logistic regression analysis.Part Three The exploration of serum CRC screening method.Using CEA as reference,the study evaluated the screening effect of serum M2-PK and serum protein profiles on cancer and precancerous lesions. Main indictors to serum M2-PK:ROC curve;ROC AUC;Sensitivity and Specificity. Main indicators to serum protein profiles:Model training;10-fold cross validation.The combined sensitivity and specificity.
【Innovative Results】
Based on study on colorectal cancer screening in Xiacheng district,the results have showed that①The CRC screening in urban area based on guideline established by our units had the same good results as in rural area.High risk factors questionnaire investigation had important role in CRC screening and it can make up the shortcomings of iFOBT and detect nonbleeding lesions,especially precancerous lesions such as adenomas and polyps;②Each high risk factor was sorted according to sensitivity and specificity for the first time among natural population in city.The unique Chinese high risk factors were proved to play important role in colorectal cancer screening.③Some issues,such as low uptake rate in primary and secondary screening,were raised in the process of urban CRC screening.Propaganda and mobilization should be reinforced on the basis of community in the primary screening.Hospital screening model should be adopted in the secondary screening.The study has established intervention program,in which high risk population was propagated and mobilized to udergo colonoscopy examination,then barrier-focused interventions were carried out to nonadherent high risk population.ⅢThe study has explored the value of serological CRC screening and show serum M2-PK and serum protein profiles may have application prospect to shrink high risk population and increase the sensitivity and specificity of colorectal cancer screening.
应用本单位先前基于中小城市农村建立的大肠癌筛查方法首次在城市社区(杭州市下城区)自然人群开展筛查实践,进一步评价及验证该方案对城市人群的筛查效果,发现并设计方案解决筛查中可能遇到的顺应性低、特异度不理想等问题,提出今后大肠癌筛查的发展方向,并探索血清学大肠癌筛查方法并评价其效果,期望为我国大肠癌筛查方案的进一步完善,提供理论和实践依据。
【研究内容】
①评价方案对城市社区自然人群的筛查效果。分析免疫法粪便潜血(iFOBT)和问卷调查结合后筛查效果。分析方案中各高危因素项目对筛查方案的作用。首次对高危因素各项目依敏感度及特异度进行排序。②通过城市与农村自然人群筛查受检率的比较,发现目前城市自然人群大肠癌筛查所遇到的受检率较低问题,为今后城市社区自然人群大肠癌筛查的具体实施提供了决策依据。③对现场筛查发现的问题如顺应性、特异度不理想等问题探索解决方案。④评价以减少顾虑、提高高危人群肠镜受检率为目地干预措施,以提高高危人群肠镜受检率。⑤以血清癌胚抗原(CEA)为参照,探索血清M2型丙酮酸激酶(M2-PK)在大肠癌筛查中的应用价值。⑥应用表面增强激光解析电离-飞行时间-质谱(SELDI-TOF-MS)技术建立高危人群腺瘤vs正常、非腺瘤性息肉vs正常、腺瘤vs非腺瘤性息肉的血清蛋白质质谱的诊断预测模型,评价预测模型在筛查中的应用前景。⑦评价血清M2型丙酮酸激酶(M2-PK)与血清蛋白质质谱的诊断预测模型联合检测的应用价值。
【研究方法】
第一部分对杭州市下城区自然人群大肠癌筛查研究①大肠癌筛查方案应用于城市社区后的筛查效果。主要指标:早诊率;癌及癌前病变检出率;初筛与精筛人群受检率;iFOBT及问卷调查的阳性率;iFOBT及问卷调查的阳性预测值;iFOBT及问卷阳性的敏感度、特异度。②iFOBT及高危因素问卷调查在筛查中的意义:主要指标:iFOBT及问卷调查分别对癌及癌前病变的检出数量及比例。③对高危因素各项目的分析:各高危因素诊断癌及癌前病变的敏感度及特异度。④检出的大肠癌、腺瘤、非腺瘤性息肉的部位分布。主要指标:病变在结肠左半(直肠、乙状结肠、降结肠)、横结肠、结肠右半(回盲部、升结肠)的分布数量及比例。⑤与海宁、嘉善农村大肠癌筛查比较。主要指标:检出率;早诊率;受检率;早期大肠癌所占的比例。第二部分对城市社区肠镜拒检高危人群的再干预通过设计问卷调查明确影响肠镜受检率的主要原因,设计以“降低顾虑,提高肠镜受检率”为目标的干预方案,采取针对性的干预措施。评价干预效果。指标:影响肠镜受检率的原因构成比;干预前后肠镜受检率的变化。应用Logistic回归分析,确定干预效果相关因素。第三部分探索血清学大肠癌的筛查方法,评价血清M2-PK和血清蛋白质谱模型对大肠癌及癌前病变的筛查效果。评价两者结合对腺瘤及非腺瘤性息肉的筛查效果。评价血清M2-PK的方法:ROC曲线,曲线下面积;敏感度;特异度。评价血清蛋白质谱模型的方法:模型训练;模型10倍交叉验证。评价两者结合方法:联合后敏感度及特异度。
【创新点与结论】
通过对下城区大肠癌筛查的研究①首次证明来自于中小城市农村的大肠癌筛查方案对城市社区自然人群与中小城市农村的自然人群一样具有较好的检出效果,证明了问卷调查对大肠癌筛查的重要作用,能弥补iFOBT不足,发现其不能检出的包括不出血病变,尤其是腺瘤、息肉;②首次在城市社区自然人群中对各高危项目根据诊断的敏感度及特异度进行了排序。验证了中国特有的高危项目在大肠癌筛查方案中起重要的作用。③发现城市社区筛查过程中存在的一些需要解决的问题,比如初筛和精筛的受检率较低的问题,开展以自然人群为基础的大肠癌筛查难度较农村更大,初筛须进一步加强基于社区的宣传与发动,精筛须采取以医院或有条件的内镜中心为主的“医院筛查模式”。④为提高高危人群肠镜受检率,首次开展对肠镜拒检人群的干预工作。研究建立了以社区宣传、发动动员高危人群行肠镜检查,然后对拒检高危人群实行以“减少顾虑、提高肠镜受检率为目标”的干预方案,并取得了较好的干预效果。⑤评价了血清学大肠癌筛查的方法,提示血清学筛查方法可有效的浓缩高危人群,对高危人群进行再一次风险评估和预警,提高大肠癌筛查的敏感度或特异度。
【Objective and Sense】
CRC Screening practice was carried out for the first time among natural population in Hangzhou city based on CRC screening guide line established previously in rural area of small and medium-sized cities.Screening effect of the guideline on city population will be evaluated.The program has been designed to solve the problem met in screening practice,such as the low uptake and specificity,etc.Serum CRC screening methods were explored and their effects evaluated in order to perfect the China CRC screening guideline and provide theory and practice basis for it.
【Content】
①The study is to evaluate the screening effectiveness among natural population in city area,analyse the screening effects of combination of iFOBT and questionnaire and show the function of each high risk factors in the screening guideline.Each high risk factor was sorted for the first time according to its sensitivity and specificity.②The problem of low uptake rate was met in the process of screening practice among city natural population.It will provide the basis of decision-making for screening practice among city natural population in the future.③Resolution was designed to the problems met in the process of screening,such as low uptake rate and specificity.④The study is to evaluate barrier focused intervention to increase the colonoscopy adherence among high-risk population.⑤Using serum CEA as reference,the study is to evaluate the application value of serum M2-PK in CRC screening.⑥Diagnosis and predictive model was established by SELDI-TOF-MS in high-risk population.The study is to evaluate the application prospects of this model in CRC screening.⑦The study is to evaluate the application value of combination of serum M2-PK and serum protein profiles model.
【Methods】
Part One:Study on CRC screening among natural population in Xiacheng district, Hangzhou.①The screening effect among natural population in city.Main indicators: Early diagnosis rate;The detection rates of cancer and precancerous lesions;Uptake rates of iFOBT and questionnaire in primary and secondary screening;Positivity rates of iFOBT and questionnaire.Positive predictive value(PPV);Sensitivity and specificity of iFOBT and questionnaire;②The functions of iFOBT and questionnaire in screening. Main indicators:Detection number and ratio of cancer or precancerous lesions.③Analysis of high risk factors.Sensitivity and specificity of high risk factors to cancer and precancerous lesions.④Location distribution of cancer,adenomas,nonpolyposis. Main indicators:The number and ratio of lesions located in left colon(rectum,sigmoid, decending colon),transverse colon,right colon(ileocecal junction,ascending colon). City screening effect in urban area was compared with that in rural aera.Main indicators:The detection rate;Early detection rate;Uptake rate;rate of early colorectal cancer.Part Two Barrier-focused intervention to Nonadherent high risk population in city CRC screening Questionnaire investigation was designed to identify the main reasons of nonadherece by telephone interview with nonadherent subjects.Barrier focused interventions were designed and were carried out accoding to reasons. Intervention effects was evaluated.Main indicators:The ratio of main barriers to colonoscopy among nonadherence high-risk subjects;The change of colonoscopy adherence rate between pre and post intervention.Factors related to intervention effect was determined by logistic regression analysis.Part Three The exploration of serum CRC screening method.Using CEA as reference,the study evaluated the screening effect of serum M2-PK and serum protein profiles on cancer and precancerous lesions. Main indictors to serum M2-PK:ROC curve;ROC AUC;Sensitivity and Specificity. Main indicators to serum protein profiles:Model training;10-fold cross validation.The combined sensitivity and specificity.
【Innovative Results】
Based on study on colorectal cancer screening in Xiacheng district,the results have showed that①The CRC screening in urban area based on guideline established by our units had the same good results as in rural area.High risk factors questionnaire investigation had important role in CRC screening and it can make up the shortcomings of iFOBT and detect nonbleeding lesions,especially precancerous lesions such as adenomas and polyps;②Each high risk factor was sorted according to sensitivity and specificity for the first time among natural population in city.The unique Chinese high risk factors were proved to play important role in colorectal cancer screening.③Some issues,such as low uptake rate in primary and secondary screening,were raised in the process of urban CRC screening.Propaganda and mobilization should be reinforced on the basis of community in the primary screening.Hospital screening model should be adopted in the secondary screening.The study has established intervention program,in which high risk population was propagated and mobilized to udergo colonoscopy examination,then barrier-focused interventions were carried out to nonadherent high risk population.ⅢThe study has explored the value of serological CRC screening and show serum M2-PK and serum protein profiles may have application prospect to shrink high risk population and increase the sensitivity and specificity of colorectal cancer screening.
引文
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