Fifth, the accuracy testing of self-sampling and urine sampling methods in our study have not been conducted. Asciutto et al. Nevertheless, our suggestions of the 2 sampling methods as an alternative to the Pap test based on previous studies and our data can be considered controversial, and thus an accuracy testing study using a much larger population should be conducted. Moreover, a cost-effective analysis is required for the use of self-sampling and urine sampling in an organized CCS program. Finally, standardized test methods for self-sampling and urine sampling are absent in Korea and these test methods may be limited as alternative modalities of Pap test.
Both test methods might especially vary depending on when and how samples are collected [ 32 ].
Materials and Methods
Thus, further studies to validate and guarantee the accuracy of these test methods are required. Despite these limitations, our study, to the best of our knowledge, is the first to compare satisfaction with clinician-collected Pap test and self-sampling and urine sampling based on HPV.
To date, the majority of studies have compared Pap test and self-sampling, with few assessing urine sampling. In this context, our findings might provide more useful evidence on urine sampling as an alternative CCS modality. In addition, our study participants used 3 modalities for CCS, which allow us to conduct more exact comparisons of both satisfaction with individual screening modalities and preferences for CCS.
In conclusion, we found that participants were more likely to report satisfaction with alternative methods self-sampling and urine sampling for CCS than then conventional Pap test. These finding suggest the possible feasibility and acceptability of the alternative modalities in improving CCS rates. Moreover, these alternative methods might be promising ways with which to resolve psychological, cultural, and geographical barriers to CCS in countries with low compliance rates.
Conflict of Interest: No potential conflict of interest relevant to this article was reported. Author Contributions: Conceptualization: H. Int J Cancer ;E— Cancer statistics in Korea: incidence, mortality, survival, and prevalence in Cancer Res Treat ;— Effectiveness of an organized cervical cancer screening program in Korea: results from a cohort study.
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Int J Cancer ;— Status of implementation and organization of cancer screening in The European Union Member States-Summary results from the second European screening report. HPV self-sampling as an alternative strategy in non-attenders for cervical screening - a randomised controlled trial. Br J Cancer ;— Barriers to cervical cancer screening attendance in England: a population-based survey. J Med Screen ;— Self-sampling experiences among non-attendees to cervical screening. Gynecol Oncol ;— Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer.
N Engl J Med ;— Women's experience with home-based self-sampling for human papillomavirus testing. BMC Cancer ; High-risk HPV testing on self-sampled versus clinician-collected specimens: a review on the clinical accuracy and impact on population attendance in cervical cancer screening. The acceptability of vaginal smear self-collection for screening for cervical cancer: a systematic review. Clinics Sao Paulo ;— Accuracy of urinary human papillomavirus testing for presence of cervical HPV: systematic review and meta-analysis.
BMJ ;g Urine testing for HPV. J Med Virol ;— Experience with high-risk human papillomavirus testing on vaginal brush-based self-samples of non-attendees of the cervical screening program. Reasons for non-attendance to cervical screening and preferences for HPV self-sampling in Dutch women. Prev Med ;— Predicting the stages of adoption of cervical cancer screening among Korean women.
Asian Pac J Cancer Prev ;— Knowledge of cervical cancer and Pap smear among Uyghur women from Xinjiang, China. BMC Womens Health ; HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ ;c Human papillomavirus infection among young adolescents in India: impact of vaccination. Attitudes and factors affecting acceptability of self-administered cervicovaginal sampling for human papillomavirus HPV genotyping as an alternative to Pap testing among multiethnic Malaysian women.
BMJ Open ;6:e Reaching women who do not participate in the regular cervical cancer screening programme by offering self-sampling kits: a systematic review and meta-analysis of randomised trials.
Eur J Cancer ;— Vaginal self-sampling is a cost-effective way to increase participation in a cervical cancer screening programme: a randomised trial. Implementation intentions and colorectal screening: a randomized trial in safety-net clinics. Am J Prev Med ;— Arbyn M, Castle PE.go
4. Evaluation questions
Offering self-sampling kits for HPV testing to reach women who do not attend in the regular cervical cancer screening program. Cancer Epidemiol Biomarkers Prev ;— Self-sampling in cervical cancer screening: comparison of a brush-based and a lavage-based cervicovaginal self-sampling device. A prospective pilot evaluation of vaginal and urine self-sampling for the Roche cobas HPV test for cervical cancer screening. Sci Rep ; Evaluating a cancer screening program involves estimating benefits and harms to determine net benefits, and then considering whether the magnitude of net benefits justifies the resources required to run a program.
This requires data on patient-important health outcomes, cost-effectiveness and public engagement to elicit values and preferences, using deliberative methods. Cancer screening trials require a large sample size — often hundreds of thousands of participants — to ensure control of potential confounding factors and detection of a difference between groups. This is resource intensive and makes it difficult to achieve adequate recruitment.
Participants may prefer a particular group than the one to which they are randomised, which can influence screening attendance. These prerequisites of cancer screening trials — long duration, large sample size and adequate adherence to the trial protocol — can make them impractical, and they may be particularly challenging to undertake once a program is established.
Any decision to implement a cancer screening program should be based on evidence of net benefit to the population, demonstrated by a reduction in all-cause mortality — that is, evidence that people are, on balance, likely to live longer if they participate in screening. A reduction in overall mortality may not be found because any decrease in cancer-specific mortality is offset or even overtaken by deaths due to downstream effects of the screening test, diagnosis or treatment. Few randomised controlled trials conducted to date have had sufficient power to show an effect on all-cause mortality.
Solutions to this include pooling trial data by meta-analysis or analysing epidemiological trends. Where there is uncertainty, new randomised controlled trials that are powered to detect a difference in all-cause mortality may be needed. Although such trials need to be very large, they are justified given the expense of population screening programs when we are uncertain if there is true benefit to society.
Trial costs may be substantially reduced if they are conducted within large, national observational registries, which may even make them comparable to the cost of current screening trials. Although randomised trial data are often used to inform decisions about whether a screening program should be implemented, they are rarely used for evaluation of benefits and harms of the program once it is established. Uncertainty may remain about specific components of the strategy, and the screening technology itself often changes over time — for example, 3D mammography for breast cancer screening 20 or liquid cytology for cervical cancer screening.
There may also be changes in cancer prevention and treatment after the implementation of a screening program. For example, improvements in breast cancer treatment 23 have meant that the mortality benefit of current mammography screening is likely to be smaller than that first observed in the original screening trials. Improvements in prevention can also decrease the incidence of cancer. For example, implementation of human papillomavirus vaccination programs has brought a decline in high-grade cervical abnormalities and reduced estimated mortality benefits from cervical cancer screening.
Ongoing evaluation of screening programs is possible using pragmatic randomised trials within the program, with the eligible population randomised to different screening strategies. Although they may be more applicable than randomised controlled trials, they are more prone to biases which usually favour screening. Nevertheless, observational studies may be useful for monitoring benefits and harms over time. An evidence based approach to cancer screening is essential to maximise benefits improved length and quality of life while minimising the harms to individuals false positives, overdiagnosis and overtreatment and opportunity costs to society.
Evaluating cancer screening remains difficult due to important biases, so we must continue to implement randomised controlled trials to generate the best evidence on the magnitude of benefits and harms with reasonable certainty. Those responsible for communicating cancer screening can do better by always providing absolute risks and ensuring transparent reporting of benefits and harms without using 5-year survival rates or relative risks.
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Evaluation of Cancer Screening | Jocelyn Chamberlain | Springer
Corresponding author Andrew Hayen andrew. Competing interests None declared. Author contributions All authors contributed to drafting the manuscript. Full text. Introduction Potential for bias in cancer screening Communication of cancer screening Evaluating whether to implement a cancer screening program Evaluating a cancer screening program after implementation Conclusions. Key points An evidence based approach to cancer screening is essential Both benefits and harms including false positives, overdiagnosis and overtreatment need to be estimated Evaluating cancer screening remains difficult because of important biases; randomised trials are the most effective way to control for lead-time, length-time, overdiagnosis and volunteer bias Communication about screening should always present benefits and harms using absolute risks and mortality.
Introduction Cancer screening is the systematic search for cancer in people who have no signs or symptoms of the disease, to identify those who probably have cancer and those who do not. Potential for bias in cancer screening Two critical forms of bias affect estimates of the effects of cancer screening: lead-time bias and length-time bias. Figure 1. Figure 2. Conclusions An evidence based approach to cancer screening is essential to maximise benefits improved length and quality of life while minimising the harms to individuals false positives, overdiagnosis and overtreatment and opportunity costs to society.
Long-term psychosocial consequences of false-positive screening mammography. Ann Fam Med. CrossRef PubMed 2. Considerable challenges, therefore, remain to bolster health equity. Components included in comprehensive quality assurance are listed in Box 4. Quality assurance also includes timely, prospective evaluations of modifications of existing programmes and for piloting new programmes 8. Adequate organization and coordination of screening are important at all stages of programme development from preplanning and feasibility testing to implementation piloting, roll-out and continuous improvement.
A programme should be thoroughly preplanned for the target ages, screening interval and tests used to identify preclinical disease. Appropriate synthesis of evidence on effectiveness, adverse effects, health-economic aspects, in combination with information on the burden of disease, is essential background information for these tasks. In this phase there should be data also for estimation of the invitational population size per year, planning for feasible schemes to cover the target population often enough interval between invitations and plans on how to reach a high uptake of the primary test and guarantee fully quality-assured management services ready at the time of starting.
Population-based cancer screening has infrastructure requirements that need to be verified or developed before starting to screen. First, the target population age, region, gender has to be individually identified to allow a call and recall system.
For follow-up of screening outcomes, population-based registration of both cancer and screening is needed. Additionally, time and cause of death has to be individually linked with screening invitation information for outcome evaluation purposes. The development of a comprehensive quality assurance plan and manual needs to precede the start of screening activity. A new programme and all its components, or new procedures in an existing programme, should be feasibility tested and piloted in a controlled fashion before national roll-out Fig.
Initial training and development of competence can be focused on a developing national screening reference centre or area, where feasibility testing and piloting can be based, and where subsequent training needs for the roll-out phase can be satisfied. The invitational procedures with call and recall, acceptance of testing, communication with the screened person, delivery of further investigations e.
For example, the uptake of screening may depend on the premises where samples are taken, opening hours, public traffic, personnel women for breast or cervical cancer screening , among many other factors. After the piloting phase, the programme can be rolled out after modifications and corrections deemed necessary based on pilot evaluation. The full implementation of the programme may take several years to achieve coverage and ensure optimal function through the screening chain.
A gradual build up is usually needed to ensure practical resources, for example colonoscopy services for those who are positive for faecal occult blood test. Integrated comprehensive quality assurance allows for further incremental improvement in a continuous quality cycle. A high level of organization with solid governance and coordinating functions also give better opportunities to stop ineffective or harmful activities in a controlled fashion.
If existing screening does not fulfil quality requirements, the decision must be either to reorganize by following EU guidelines or ultimately to stop the ineffective programme. Continuation of an ineffective programme is unacceptable. Modifications from ongoing opportunistic testing either self-selection or general recommendations as opposed to invitation based towards population-based programmes are encouraged. Implementation of population-based screening should be a carefully managed multistep process through the phases of coordinated planning, piloting, roll-out and continuous improvement.
Following the political decision with associated budget allocations to start implementing a population-based cancer screening programme, and formulation of its goals and frameworks, the first step is to establish coordination and allocate institutional responsibilities. The institution housing the management unit should receive a clear mandate and resources to manage the entire process of programme implementation depicted in Fig.
The management unit also has to prepare the budget details through all phases, including the resources required for quality assurance, programme management and staff training. The work necessitates close collaboration with authorities and all stakeholders, preferably within a well-defined and mandated governance structure Fig. The mandate may also require changes in national legislation to ensure that it does not contradict effective implementation. Considerable autonomy to take organizational decisions must be allowed for coordination.
It is essential that a screening programme is managed by specialists with adequate knowledge and training in the subject areas of cancer screening. Specific training possibilities in the EU are available.
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Experience from other EU countries could be helpful; experts from other countries should be involved as consultants if local expertise is unsatisfactory. Professional expertise should be utilized from the planning phase development of standards and quality indicators and throughout the implementation and for continuous evaluation. The professional and organizational management structure must be equipped with the competence and the mandate to control the quality of the entire screening process.
Recent European guidelines and available European expertise should be consulted regarding questions on efficacy and effectiveness of new technologies. In that case national health technology assessment agencies could focus on questions related to local implementation and costs.
Registration and information technology systems The formation of a centralized data registration system for quality assurance is critical for the success of a programme. The format of the data follows standards developed by professionals and based on the European quality assurance guidelines. Although linkage to the screening procedure reimbursement system is desired, it is essential that the system is not limited to invitation and procedure reimbursement but also covers performance and outcome of the screening programme.
The requirements for continuous quality assurance should be considered early on and incorporated when designing the comprehensive information technology system that covers the entire screening process, including the quality of treatment of detected lesions. The established quality assurance system should also be used for procedures outside the screening programme. In most EU countries, the screening data platform has not been embedded in a comprehensive clinical health e-health data system; however, this would be highly recommended.
The Council of the European Union recognized that quality screening includes analysis of the process and outcome of the screening, and that this analysis is facilitated if the screening database can be linked to cancer and mortality databases 5. The European guidelines for quality assurance in breast, cervical and colorectal screening 10,12,13 all emphasize data linkage between screening and cancer registries; implementation has, however, been limited throughout Europe A set of performance indicators has been generated separately for each screening programme for comparative monitoring at the European level, and the importance of linking the screening data not only with cancer registry data but also with other registries of interest population, cause of death, diagnostic and treatment registries and, more recently, HPV vaccination and biomaterial registries has been emphasized 26, While the linkage between cancer registries and mortality databases has been established in most European cancer registries, linking the data from national screening databases and cancer registries still poses a significant issue in some Fig.
The Council of the European Union recommendation mentions a need for monitoring specific performance indicators, without detailing the nature of these indicators. The specific guidelines discussed above describe these indicators thoroughly and set the desired levels. The other approach to assessing performance is the rate of false positives recalled women whose examinations end with a negative result and the overdiagnosis rate breast cancers that would not have come to clinical attention were it not for screening.
Integrated evaluation chapter continues in part II. See part II of Cancer screening chapter. Cancer screening, part I Policy recommendations on governance, organization and evaluation of cancer screening This is a part I of chapter Cancer screening Cancon work package 9 of the Guide. If resources are scarce, a good approach may be to start with a limited target population, with the view to expand when quality is established and resources allow, rather than compromise on quality assurance.
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