Comparison of the performance of HPV DNA chip test and HPV PCR test in cervical cancer screening in rural China.

Background: This study aimed to evaluate the performance of two different principles of HPV testing in primary cervical cancer screening and ASC-US triage in rural areas. Methods: 3,328 and 3,913 women were enrolled in Shanxi, China in 2017 and 2018, respectively, and screened using liquid-based cytology and different HPV tests with a 4-year follow-up. Different screening methods commonly used in clinical practice were evaluated. Results: In the HPV PCR test cohort, the prevalence of HPV infection was 14.90%. A total of 38 cases of CIN2+ were identified at baseline, 2 of which were in the HPV-negative cohort and the rest in the HPV-positive cohort (2 = 186.85, p < 0.001). Fifty-three cases of CIN2+ were accumulated over 4 years. The HPV infection rate in the HPV DNA chip test cohort was 21.10%. A total of 26 CIN2+ cases were identified at baseline, all in the HPV-positive population (2 = 92.96, p < 0.001). 54 CIN2+ cases were cumulative over 4 years. At 4-year follow-up, HPV-negative results were significantly more protective against cervical intraepithelial neoplasia grade 2 or worse (CIN2+) than normal cytologic results at baseline. HPV screening was more sensitive and specific than cytologic screening (using ASC-US as the threshold) and performed better on the HPV DNA microarray test. In addition, compared with HPV 16/18 testing, sensitivity increases and specificity decreases when using HPV testing for cytologic ASC-US triage, regardless of which HPV test is used. Conclusion: In the rural areas where we implemented the study, HPV tests performed well for screening than LBC and HPV DNA chip testing performed better than HPV PCR testing in the screening cohort. Optimal screening was achieved technically when used in combination with LBC for ASC-US population triage, without thinking the feasibility for resource availability.

Comparison of primary cytology, primary HPV testing and co-testing as cervical cancer screening for Chinese women: a population-based screening cohort.

OBJECTIVES: We compared clinical performance of three strategies of primary human papillomavirus (HPV) testing, primary cytology and co-testing for cervical cancer screening. DESIGN: A population-based prospective cohort study of clinical performance of screening strategy. SETTING: Patients recruited from community in Changzhi County, Shanxi Province, China. PATIENT: 3209 women aged 30-64 years without gynaecological issues. PRIMARY AND SECONDARY OUTCOME MEASURES: The performance of different screening strategies for detecting cervical intraepithelial neoplasia grade 2 or more severe (CIN2+). RESULTS: A total of 53 CIN2+ and 31 CIN3+ cases are detected. For CIN2+, sensitivity of primary HPV (95.9%) and co-testing (98.0%) are not statistically different, but significantly higher than primary cytology (48.0%). Specificity (86.8%), colposcopy referral rate (7.8%) and number of colposcopies required to detect one case (9.8) for primary HPV are better than co-testing (79.8%, 11.9%, 14.3%, respectively). For CIN3+, primary HPV, co-testing have 100% of sensitivity and specificity, which is significantly higher than primary cytology (56.7% and 90.2%). Number of colposcopies required to detect one case for primary HPV (15.9) is better than co-testing (23.8). CONCLUSIONS: Compared with co-testing, HPV primary screening had comparable sensitivity and higher specificity for CIN2+ detection, and both of them showed better performance than cytology primary screening in cervical cancer screening.

Concordance between the BD Onclarity and Roche cobas assays for detection of HPV DNA in a Chinese population.

As cervical cancer screening shifts from cytology to human papillomavirus (HPV) testing, a major issue involves validating more HPV tests. In recent years, some HPV tests are used for clinical performance verification in China. The purpose of this study was to explore whether the BD Onclarity (Becton, Dickinson and Company)HPV assay differs from the Roche cobas (Roche Molecular Systems)HPV assay, as determined using 944 cervical samples, including 588 with sequencing results. In the nucleic acid assay accuracy verification, the assays showed excellent concordance for detection of HPV16 (κ = 0.93, 95% confidence interval [CI]: 0.89-0.97) and HPV18 (κ = 0.90, 95% CI: 0.83-0.97), and very good concordance for the 12 other high-risk types (HPV31/33/35/39/45/51/52/56/58/59/66/68, κ = 0.79, 95% CI: 0.75-0.83). The overall agreement for HPV DNA detection between Onclarity and cobas was very good (κ = 0.7755). No difference for ≥CIN2 sensitivity was observed between Onclarity and cobas (both 96.5%), whereas the ≥CIN2 specificity for detection of Onclarity (16.6%, 95% CI: 13.7-19.9) was higher than that of cobas (11.5%, 95% CI: 9.1-14.5). Onclarity exhibited comparable screening performance and triage efficiency compared to cobas in the detection of cervical disease in Chinese women.

Effect of a school-based educational intervention on HPV and HPV vaccine knowledge and willingness to be vaccinated among Chinese adolescents : a multi-center intervention follow-up study.

BACKGROUND: Middle school students are recommended as the primary target population for human papillomavirus (HPV) vaccination. This study aimed to assess HPV and HPV vaccine knowledge, and to evaluate the effect of a school-based educational intervention, immediately and one year later, on HPV knowledge and vaccine acceptability among adolescents in mainland China. METHODS: A school-based interventional follow-up study was conducted in seven representative cities in mainland China from May 2015 to May 2017. "Train-the-trainer" strategy was employed to educate school teachers in this study. Students aged 13 to 14 years old were assigned to intervention classes and control classes. All students were required to complete the baseline questionnaire. Students in the intervention classes were given a 45-minute lecture regarding HPV and HPV vaccine knowledge and were then asked to complete a post-education questionnaire. One year later, all students were asked to complete the post-education questionnaire again. RESULTS: Baseline HPV knowledge was low among Chinese adolescents, with only 12.6% and 15.7% of students having heard of HPV and HPV vaccines, respectively. After the intervention, the level of HPV-related knowledge increased immediately, and students with higher knowledge levels of HPV and HPV vaccines were more willing to get vaccinated. One year after the intervention, the knowledge of HPV and HPV vaccines was dramatically diminished. However, knowledge was significantly higher in intervention classes compared to control classes. CONCLUSIONS: Knowledge and awareness of HPV and vaccination are generally deficient among Chinese adolescents. School-based health education was very effective in improving awareness and positive attitudes about HPV and HPV vaccines within a short time. Integrating health education on HPV into the existing school-based sexual health curriculum could be an effective way to increase HPV vaccination coverage and help to eliminate preventable HPV-associated cancers in China.

Cost and cost-effectiveness of a school-based education program to reduce salt intake in children and their families in China.

OBJECTIVE: The School-based Education Program to Reduce Salt Intake in Children and Their Families study was a cluster randomized control trial among grade five students in 28 primary schools and their families in Changzhi, China. It achieved a significant effect in lowering systolic blood pressure (SBP) in all family adults by 2.3 mmHg and in elderlies (aged > = 60 years) by 9.5 mmHg. The aim of this study was to assess the cost-effectiveness of this salt reduction program. METHODS: Costs of the intervention were assessed using an ingredients approach to identify resource use. A trial-based incremental cost-effectiveness ratio (ICER) was estimated based on the observed effectiveness in lowering SBP. A Markov model was used to estimate the long-term cost-effectiveness of the intervention, and then based on population data, extrapolated to a scenario where the program is scaled up nationwide. Findings were presented in terms of an incremental cost per quality-adjusted life year (QALY). The perspective was that of the health sector. RESULTS: The intervention cost Int$19.04 per family and yielded an ICER of Int$2.74 (90% CI: 1.17-12.30) per mmHg reduction of SBP in all participants (combining children and adult participants together) compared with control group. If scaled up nationwide for 10 years and assumed deterioration in treatment effect of 50% over this period, it would reach 165 million families and estimated to avert 42,720 acute myocardial infarction deaths and 107,512 stroke deaths in China. This would represent a gain of 635,816 QALYs over 10-year time frame, translating into Int$1,358 per QALY gained. CONCLUSION: Based on WHO-CHOICE criteria, our analysis demonstrated that the proposed salt reduction strategy is highly cost-effective, and if scaled up nationwide, the benefits could be substantial. TRIAL REGISTRATION: ClinicalTrials.gov NCT01821144.

Salt intake belief, knowledge, and behavior: a cross-sectional study of older rural Chinese adults.

Excess sodium consumption is a major cause of high blood pressure and subsequent vascular disease. However, the factors driving people's salt intake behavior remains largely unknown. This study aims to assess the relationship of salt intake behaviors with knowledge and belief on salt and health among older adults in rural China.A cross-sectional survey was conducted among 4693 older participants (men ≥50 and women ≥60 years old) randomly selected from 120 rural villages in 5 northern provinces in China. Healthy salt intake behavior was defined as either not eating pickled foods or not adding pickles/soy sauce/salt when food was not salty enough in prior 3 months.There were 81% participants having healthy salt intake behavior. Healthy salt intake behavior was more common among women (P < 0.01) and was positively associated with age (P < 0.01) and poorer health status (P < 0.01), but negatively associated with years in school (P < 0.05). After adjusting for age, sex, years in school, and health status, participants who believed in the harm of high salt intake were more likely to have healthy salt intake behavior, compared with those who did not believe (Odds Ratio = 1.6, P < 0.001). Knowledge of salt intake was not significantly related to healthy salt intake behavior.Our study demonstrated that belief in the harm of high salt intake rather than knowledge about salt and health was associated with healthy salt intake behavior, independent of age, sex, years in school, and health status. Future population salt reduction programs should place more emphasis on establishing health beliefs rather than only delivering salt-related knowledge.Clinical trial registration number of the study is NCT01259700.

A school-based education programme to reduce salt intake in children and their families (School-EduSalt): protocol of a cluster randomised controlled trial.

INTRODUCTION: The current salt intake is very high for children as well as adults in China. A reduction in salt intake is one of the most cost-effective measures to curb the rapidly growing disease burden attributed to blood pressure and cardiovascular disease in the Chinese population. A lower salt diet starting from childhood has the potential to prevent the development of such conditions. The School-EduSalt (School-based Education Programme to Reduce Salt) study aims to determine whether an education programme targeted at school children can lower salt intake in children and their families. METHODS AND ANALYSIS: The study is designed as a cluster randomised controlled trial. The location is Changzhi, Shanxi province in northern China. The study population will consist of 28 primary schools with 280 children aged ≈11 years and 560 adult family members. Children in the intervention group will be educated on how to reduce salt intake. They will then be empowered to deliver the salt reduction message home to their families. In particular, children need to persuade the person who does the cooking to reduce the amount of salt used during food preparations. The duration of the intervention is one school term (≈4.5 months). The primary outcome is the difference between the intervention and the control group in the change in 24 h urinary sodium and the secondary outcome is the difference between the intervention and control group in the change of blood pressure. An economic evaluation will be undertaken to assess cost-effectiveness. ETHICS AND DISSEMINATION: The study has been approved by The Queen Mary Research Ethics Committee (QMREC2012/81) and Peking University Health Science Centre IRB (IRB00001052-12072). Study findings will be disseminated widely through conference presentations and peer-reviewed publications. PROTOCOL REGISTRATION: Protocol Registered on ClinicalTrials.gov NCT01821144.

Combined screening of cervical cancer, breast cancer and reproductive tract infections in rural China.

OBJECTIVES: To investigate the current prevalence and knowledge of cervical cancer, breast cancer and reproductive tract infections (RTIs) in rural Chinese women, and to explore the acceptance and feasibility of implementing a combined screening program in rural China. METHODS: A population-based, cross-sectional study was conducted among women aged 30 to 59 years old in Xiangyuan County, Shanxi Province from 2009 to 2010. Socio-demographic characteristics, knowledge of cervical cancer, breast cancer and RTIs, and the attitude toward single or combined screening were collected by an interview questionnaire. Each participant received a clinical examination of the cervix, breast and reproductive tract. Examinations included visual inspection, mammography, laboratory tests and pathological diagnosis. RESULTS: A total of 1,530 women were enrolled in this study. The prevalence of cervical precancerous lesions, suspicious breast cancer, suspicious benign breast disease and RTIs was 1.4%, 0.2%, 14.0% and 54.3%, respectively. Cervicitis, trichomonas vaginitis, and bacterial vaginitis were the three most common RTIs among our participants. Television, radio broadcast, and public education during screening were the major source of healthcare knowledge in rural China. Moreover 99.7% of women expressed great interest in participating in a combined screening project. The affordable limit for combined screening project was only 50 RMB for more than half of the rural women. CONCLUSION: A combined screening program would be more effective and popular than single disease screening projects, while appropriate accompanied education and a co-pay model for its successful implementation need to be explored, especially in low-resource settings.

A multi-center survey of HPV knowledge and attitudes toward HPV vaccination among women, government officials, and medical personnel in China.

OBJECTIVES: To assess knowledge of HPV and attitudes towards HPV vaccination among the general female population, government officials, and healthcare providers in China to assist the development of an effective national HPV vaccination program. METHODS: A cross-sectional epidemiologic survey was conducted across 21 urban and rural sites in China using a short questionnaire. 763 government officials, 760 healthcare providers, and 11,681 women aged 15-59 years were included in the final analysis. Data were analyzed using standard descriptive statistics and logistic regression. RESULTS: Knowledge of HPV among the general female population was low; only 24% had heard of HPV. Less than 20% of healthcare providers recognized sexually naive women as the most appropriate population for HPV vaccination. There was high acceptance of the HPV vaccine for all categories of respondents. Only 6% of women were willing to pay more than US $300 for the vaccine. CONCLUSIONS: Aggressive education is necessary to increase knowledge of HPV and its vaccine. Further proof of vaccine safety and efficacy and government subsidies combined with increased awareness could facilitate development and implementation of HPV vaccination in China.

Estimation of the costs of cervical cancer screening, diagnosis and treatment in rural Shanxi Province, China: a micro-costing study.

BACKGROUND: Cost estimation is a central feature of health economic analyses. The aim of this study was to use a micro-costing approach and a societal perspective to estimate aggregated costs associated with cervical cancer screening, diagnosis and treatment in rural China. METHODS: We assumed that future screening programs will be organized at a county level (population ~250,000), and related treatments will be performed at county or prefecture hospitals; therefore, this study was conducted in a county and a prefecture hospital in Shanxi during 2008-9. Direct medical costs were estimated by gathering information on quantities and prices of drugs, supplies, equipment and labour. Direct non-medical costs were estimated via structured patient interviews and expert opinion. RESULTS: Under the base case assumption of a high-volume screening initiative (11,475 women screened annually per county), the aggregated direct medical costs of visual inspection, self-sampled careHPV (Qiagen USA) screening, clinician-sampled careHPV, colposcopy and biopsy were estimated as US$2.64,$7.49,$7.95,$3.90 and $5.76, respectively. Screening costs were robust to screening volume (<5% variation if 2,000 women screened annually), but costs of colposcopy/biopsy tripled at the lower volume. Direct medical costs of Loop Excision, Cold-Knife Conization and Simple and Radical Hysterectomy varied from $61-544, depending on the procedure and whether conducted at county or prefecture level. Direct non-medical expenditure varied from $0.68-$3.09 for screening/diagnosis and $83-$494 for pre-cancer/cancer treatment. CONCLUSIONS: Diagnostic costs were comparable to screening costs for high-volume screening but were greatly increased in lower-volume situations, which is a key consideration for the scale-up phase of new programs. The study's findings will facilitate cost-effectiveness evaluation and budget planning for cervical cancer prevention initiatives in China.

A multi-center survey of age of sexual debut and sexual behavior in Chinese women: suggestions for optimal age of human papillomavirus vaccination in China.

OBJECTIVE: Cervical cancer is the second most common cancer among women worldwide, and over 85% of cervical cancers occur in developing countries such as China. Lack of resources for nationwide cervical cancer screening in China makes vaccination against oncogenic strains of HPV particularly important. Knowledge of age at sexual debut and sexual behavior is essential prior to implementation of a national vaccination program. METHODS AND MATERIALS: A cross-sectional epidemiologic survey was conducted across 21 urban and rural sites in China to assess age at sexual debut and sexual behavior. 98.6% of the 11,852 recruited women aged 15-59 years were included in the analysis. Data were collected using a short, nurse-administered questionnaire and analyzed using standard descriptive statistics and survival analysis. RESULTS: In urban areas, more than ten percent of the 15-19 year old age group were already sexually active at the time of interview; this number increased to nearly 44% in the 20-24 year old age group. Chinese young women with an occupation were more likely to be sexually active compared to female students of the same age, irrespective of area of residence. The crude median sexual debut age for the youngest age group was 17 years, earlier than the sexual debut age reported by older cohorts. Younger age cohorts had an earlier menarche age than older cohorts and were more likely to have more sexual partners than older women, and more likely to have partners with more than one female partner. CONCLUSION: There is a trend towards earlier sexual debut and riskier sexual behaviors in younger age groups of Chinese women. These findings suggest that HPV vaccination of women between the ages of 13 and 15 years, before the completion of national compulsory education, is likely to contribute to the prevention of HPV infection and cervical cancer in China.

Impact of genital warts on health related quality of life in men and women in mainland China: a multicenter hospital-based cross-sectional study.

BACKGROUND: Information on the health-related quality of life (HRQoL) of patients with genital warts (GW) in populations in mainland China is still limited. The aim of the study was to use a generic instrument to measure the impact of genital warts on HRQoL in men and women in this setting. METHODS: A multi-centre hospital-based cross-sectional study across 18 centers in China was conducted to interview patients using the European quality of life-5 dimension (EQ-5D) instrument; respondents' demographic and clinical data were also collected. RESULTS: A total of 1,358 GW patients (612 men, 746 women) were included in the analysis, with a mean age of 32.0 ± 10.6 years. 56.4% of the patients reported some problems in the dimension of Anxiety/Depression (highest), followed by Pain/Discomfort (24.7%) and Mobility (3.5%). The overall visual analogue scale (VAS) score of the study population was found to be 65.2 ± 22.0, and the EQ-5D index score was found to be 0.843 ± 0.129 using Japanese preference weights (the Chinese preference was unavailable yet). Patients with lower VAS means and EQ-5D index scores were more often female, living in urban area, and suffering multiple GW (all p values < 0.05), but the values did not differ notably by age (p values > 0.05). CONCLUSIONS: The HRQoL of patients with GW was substantially lower, compared to a national representative general population in China (VAS = ~80); the findings of different subgroups are informative for future GW prevention and control efforts.

Evaluation of primary HPV-DNA testing in relation to visual inspection methods for cervical cancer screening in rural China: an epidemiologic and cost-effectiveness modelling study.

BACKGROUND: A new lower-cost rapid-throughput human papillomavirus (HPV) test (careHPV, Qiagen, Gaithersburg, USA) has been shown to have high sensitivity for the detection of high grade cervical intraepithelial neoplasia. METHODS: We assessed the outcomes and cost-effectiveness of careHPV screening in rural China, compared to visual inspection with acetic acid, when used alone (VIA) or in combination with Lugol's iodine (VIA/VILI). Using data on sexual behaviour, test accuracy, diagnostic practices and costs from studies performed in rural China, we estimated the cost-effectiveness ratio (CER) and associated lifetime outcomes for once-lifetime and twice-lifetime screening strategies, and for routine screening at 5-yearly, 10-yearly and IARC-recommended intervals. The optimal age range for once-lifetime screening was also assessed. RESULTS: For all strategies, the relative ordering of test technologies in reducing cervical cancer incidence and mortality was VIA (least effective); VIA/VILI; careHPV@1.0 pg/ml and careHPV@0.5 pg/ml (most effective). For once-lifetime strategies, maximum effectiveness was achieved if screening occurred between 35-50 years. Assuming a participation rate of ~70%, once-lifetime screening at age 35 years would reduce cancer mortality by 8% (for VIA) to 12% (for careHPV@0.5) over the long term, with a CER of US$557 (for VIA) to $959 (for careHPV@1.0) per life year saved (LYS) compared to no intervention; referenced to a 2008 GDP per capita in Shanxi Province of $2,975. Correspondingly, regular screening with an age-standardised participation rate of 62% (which has been shown to be achievable in this setting) would reduce cervical cancer mortality by 19-28% (for 10-yearly screening) to 43-54% (using IARC-recommended intervals), with corresponding CERs ranging from $665 (for 10-yearly VIA) to $2,269 (for IARC-recommended intervals using careHPV@1.0) per LYS. CONCLUSIONS: This modelled analysis suggests that primary careHPV screening compares favourably to visual inspection screening methodologies in rural China, particularly if used as part of a regular screening program.

Factors associated with smoking cessation among Chinese adults in rural China.

OBJECTIVES: To examine the factors associated with smoking cessation among adult Chinese males in rural China. METHODS: The data were collected by face-to-face interviews at the respondents' household using interviewer-administered questionnaires. RESULTS: The factors associated with quitting were being residents of Guiyang, having received junior or high school education, being unmarried, being a farmer or other job holder, smoking fewer than 20 cigarettes per day, starting smoking late, smoking for shorter duration, and having a high mean score on hedonism seeking. CONCLUSIONS: Several predictors of successful quitting were identified that could help improve smoking cessation programs in China. The findings also have implications for the need for future surveys on the quitting process among rural Chinese.

Smoking patterns and sociodemographic factors associated with tobacco use among Chinese rural male residents: a descriptive analysis.

BACKGROUND: Although evidence has shown high prevalence rates of tobacco use in the general urban populations in China, relatively little is known in its rural population. The purposes of this study were to examine smoking patterns and sociodemographic correlates of smoking in a sample of rural Chinese male residents. METHODS: The study employed a cross-sectional, multi-stage sampling design. Residents (N = 4,414; aged 15 years and older) were recruited from four geographic regions in China. Information on participants' tobacco use (of all forms), including their daily use, and sociodemographic characteristics were collected via survey questionnaires and the resultant data were analyzed using chi-square tests and logistic regression procedures. RESULTS: The overall smoking prevalence in the study sample was 66.8% (n = 2,950). Of these, the average use of tobacco products per day was 12.70 (SD = 7.99) and over 60% reported daily smoking of more than 10 cigarettes. Geographic regions of the study areas, age of the participants, marital status, ethnicity, education, occupation, and average personal annual income were found to be significantly associated with an increased likelihood of smoking among rural Chinese male residents. CONCLUSION: There is a high smoking prevalence in the Chinese rural population and smoking behaviors are associated with important sociodemographic factors. Findings suggest the need for tobacco control and intervention policies aimed at reducing tobacco use in Chinese rural smoking populations.

[Study on the relationship between polymorphisms of XPA gene and susceptibility of esophageal cancer].

OBJECTIVE: To explore the relationships between the polymorphisms of xeroderma pigmentosum A (XPA) and the susceptibility of esophageal cancer (EC), as well as its interaction with environmental factors-gene in Changzhi area, Shanxi province. METHODS: A case-control study was conducted, including 196 cases of EC and 201 controls. XPA 23G polymorphisms were determined with polymerase chain-restriction on fragment length polymorphism (PCR-RFLP). RESULTS: The risk of EC was significantly degraded in the individuals who had been carrying the XPA heterozygote (A/G) and mutation genotype (G/G), compared to those with wild genotype (chi2 = 16.21, P < 0.01) and the ORs were 0.58 (0.37-0.91) and 0.32 (0.18-0.56), respectively. There was negative interaction between XPA 23G mutation genotype and the consumption of pickled food (S = 0.04, API= -0.77). CONCLUSION: Genetic polymorphism in the XPA 23G might be associated with esophageal cancer in Changzhi area, and there was a negative action between XPA predisposing genotype and the consumption of pickled food.