A second generation cervico-vaginal lavage device shows similar performance as its preceding version with respect to DNA yield and HPV DNA results

Contains fulltext : 118480.pdf (publisher's version ) (Open Access)BACKGROUND: Attendance rates of cervical screening programs can be increased by offering HPV self-sampling to non-attendees. Acceptability, DNA yield, lavage volumes and choice of hrHPV test can influence effectiveness of the self-sampling procedures and could therefore play a role in recruiting non-attendees. To increase user-friendliness, a frequently used lavage sampler was modified. In this study, we compared this second generation lavage device with the first generation device within similar birth cohorts. METHODS: Within a large self-sampling cohort-study among non-responders of the Dutch cervical screening program, a subset of 2,644 women received a second generation self-sampling lavage device, while 11,977 women, matched for age and ZIP-code, received the first generation model. The second generation device was different in shape, color, lavage volume, and packaging, in comparison to its first generation model. The Cochran's test was used to compare both devices for hrHPV positivity rate and response rate. To correct for possible heterogeneity between age and ZIP codes in both groups the Breslow-Day test of homogeneity was used. A T-test was utilized to compare DNA yields of the obtained material in both groups. RESULTS: Median DNA yields were 90.4 mug/ml (95% CI 83.2-97.5) and 91.1 mug/ml (95% CI 77.8-104.4, p= 0.726) and hrHPV positivity rates were 8.2% and 6.9% (p= 0.419) per sample self-collected by the second - and the first generation of the device (p= 0.726), respectively. In addition, response rates were comparable for the two models (35.4% versus 34.4%, p= 0.654). CONCLUSIONS: Replacing the first generation self-sampling device by an ergonomically improved, second generation device resulted in equal DNA yields, comparable hrHPV positivity rates and similar response rates. Therefore, it can be concluded that the clinical performance of the first and second generation models are similar. Moreover, participation of non-attendees in cervical cancer screening is probably not predominantly determined by the type of self-collection device

Improving behaviour in self-testing (IBIS): Study on frequency of use, consequences, information needs and use, and quality of currently available consumer information (protocol)

<p>Abstract</p> <p>Background</p> <p>Self-tests are available to consumers for more than 25 conditions, ranging from infectious diseases to cardiovascular risk factors. Self-tests are defined as in-vitro tests on body materials such as blood, urine, faeces, or saliva that are initiated by consumers to diagnose a particular disorder or risk factor without involving a medical professional. In 2006, 16% of a sample of Dutch Internet users had ever used at least one self-test and 17% intended to use a self-test in the future. The objectives of this study are to determine (1) the frequency of self-test use, (2) the consumers' reasons for using or not using a self-test, (3) the information that is used by self-testers in the different self-test stages and the consumers' interpretation of the quality of this information, (4) the consumers' response to self-test results in terms of their confidence in the result, reassurance by the test result, and follow-up behaviour, (5) the information consumers report to need in the decision making process of using or not using a self-test, and in further management on the basis of the self-test result, and (6) the quality of the currently available consumer information on a selected set of self-tests.</p> <p>Methods</p> <p>Mixed methods study with (1) a cross-sectional study consisting of a two-phase Internet-questionnaire, (2) semi-structured interviews with self-testers and consumers who intend to use a self-test, and (3) the assessment of the quality of consumer information of self-tests. The Health Belief Model and the Theory of Planned Behaviour will serve as the theoretical basis for the questionnaires and the interview topic guides.</p> <p>Conclusions</p> <p>The self-testing area is still in a state of flux and therefore it is expected that self-test use will increase in the future. To the best of our knowledge, this is the first study which combines quantitative and qualitative research to identify consumers' information needs and use concerning self-testing, and the consumers' actual follow-up behaviour based on the self-test result, and simultaneously investigates the quality of the currently available consumer information. The results of this study will be used as an input in developing consumer information on self-testing.</p

Genotyping for Human Papillomavirus Types 16 and 18 in Women With Minor Cervical Lesions

Drs. Arbyn and Verdoodt and Ms. Xu were supported by the Belgian Foundation Against Cancer, Brussels, Belgium; the European Commission through the COHEAHR Network (grant no. 603019), coordinated by the Free University of Amsterdam (Amsterdam, the Netherlands), funded by the 7th Framework Programme of DG Research (Brussels, Belgium); the Joint Action CANCON, which has received funding from the European Union in the framework of the Health Programme (2008-13); and the Medizinische Hochschule of Hannover (Hannover, Germany). Dr. Khan was supported by training grant 5T32AI065388-05 from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, institutional grant UL1 RR024131 through the National Institutes of Health/National Center for Research Resources University of California San Francisco–Clinical and Translational Science Institute Strategic Opportunities Support program, and mentored career development award K12 HS023009 through the Agency for Healthcare Research and Quality