Organized Cervical Cancer Screening Programs

In many countries, cervical cancer screening began as opportunistic screening — that is, screening that is initiated by a health care professional or patient. This opportunistic screening, as well as local organized screening programs, over time matured into larger, sometimes national, programs.⁴¹⁵ In Canada, there are currently several organized provincial cervical cancer screening programs in place. These organized screening programs have the potential to facilitate the implementation of HPV-based screening because they could play a lead role in centralized data collection and follow-up strategies to improve or manage screening participation.⁴¹⁶ The CPAC states that organized screening programs are the most important system-level strategy used to date for ensuring optimal screening participation.¹

Of note, Canada’s three territories and the province of Quebec do not have organized cervical cancer screening programs,^22,417 therefore, different implementation strategies may be required there. Some authors have suggested a greater role for HPV self-sampling;⁴¹⁷ while others feel that for HPV testing for primary cervical cancer screening to be successful, organized screening programs would need to be established everywhere.

“Organized screening programs can help integrate all the data, link test results to patient recalls, and ensure standardized follow-up.” (Dr. Manon Auger, Director, Cytopathology Laboratory, McGill University Health Centre; and Professor, Department of Pathology, McGill University: personal communication, 2017 November 24.)

Planning, Investment, and Program Administration

The Pan American Health Organization (PAHO) and World Health Organization (WHO) recommend that a decision to introduce HPV testing into a cervical cancer screening program should be taken at the highest level of the public health authority and as part of a public health strategy to improve the screening program. Engaging the main stakeholders (such as provincial health ministries, cervical cancer screening programs, obstetric groups, and cancer organizations) from the beginning of the planning process and building consensus among them are thought to be key components to ensure effective introduction of this new technology.⁴¹⁸

“It is important to have a unified message. When there are many people and organizations giving different advice about cervical cancer screening, it negates the benefits. We need a consensus statement, one main guideline, and we need to have everyone onboard.” (Dr. Marc Steben, Medical advisor, STI unit, Institute national de santé publique du Québec, Montreal, Quebec: personal communication, 2017 December.)

In general, when a new screening program is being established, it has been suggested that adequate investment in staff and equipment (for carrying out the screening test, diagnosis of cervical cancer, treatment, and administration of the screening program) are available before the new program begins.^414,419

Step-Wise Approach

International health organizations have recommended that a step-wise approach, starting with small pilot sites, could facilitate implementation.^418,419 Different components of the screening program set-up could be tested within the local health care system before being introduced into a large population. Based on lessons learned at the pilot sites, a program can be expanded to other geographical areas as resources permit (though that may create issues of equity).^411,418,419

Performance Monitoring and Evaluation

Performance monitoring and evaluation of a new screening program are believed to be important. It has been noted that the identification of performance indicators included within the development of screening policy and management guidelines may be helpful.^412,418 In the UK, to ensure accountability of the HPV primary screening program, Cancer Research UK has suggested that a clear implementation plan with timelines should be made publicly available and that updates about the status of implementation (e.g., data on program reach and uptake) should be published regularly.⁴¹³

A panel of experts on HPV testing convened by the CPAC has stated that ongoing evaluation of screening, follow-up, and outcomes is critical.² The Pan-Canadian Cervical Cancer Screening Network recommends developing multidisciplinary committees to monitor and evaluate quality and utilization of HPV-based screening.⁴¹⁴

In the laboratory sector, quality assurance of tests could facilitate implementation because it will help ensure that the new tests are working as expected.^419–421 “Quality assurance is particularly important when new technologies and processes are being implemented. For HPV-based screening, quality assurance needs to be done at all levels: molecular, cytology, and histolog.” (Dr. Manon Auger: personal communication, 2017 November).

Participation in external quality assessment (proficiency testing and confirmatory testing) may enable laboratories to verify that they have successfully implemented HPV detection and typing assays.¹⁶ Inter-laboratory performance might be evaluated by sending proficiency panels to the laboratories.⁴²¹ Planning quality assurance methods in advance may help facilitate implementation by ensuring that newly implemented tests or testing pathways (i.e., HPV tests and cytology triage tests) are producing the expected results.^2,419–421

Loss of Specificity

The loss of specificity that accompanies the increased sensitivity of HPV testing is an identified barrier to successful implementation.^17,416 This barrier has delayed the acceptance of HPV-based screening in Canada.⁴²⁴ Lower specificity and a corresponding increase in sensitivity may lead to a potential increase in referral for colposcopy and any unwanted effects of subsequent unnecessary treatments are major factors when considering primary HPV-based screening.^411,424

The authors of a recent study found that specificity can also be adversely affected in the context of a triage system where cytotechnicians are influenced by knowing the HPV status of a sample. The heightened attention of the cytotechnicians appeared to have led to more false-positive results.⁴²⁰ The study authors speculated whether the loss in specificity could be counteracted by a well-organized quality assurance program. Third-party review by a cytopathologist was also thought to potentially improve accuracy.⁴²⁰

Optimal Screening Age and Interval

The use of HPV testing instead of cytology testing for cervical cancer screening has the potential to identify transient HPV infections, which are particularly prevalent in those younger than 25 and are likely to resolve on their own and not lead to cancer diagnoses or the need for further interventions.^82,422,425 Implementing a later start age for screening (e.g., 25 to 30 years old) and reducing the screening frequency (e.g., to every four or five years) is expected to mitigate the problem of over-screening and overdiagnosis.^16,422,426

Triage Strategies

It has been suggested that triage following the primary HPV test has the potential to alleviate problems associated with low specificity and overdiagnosis and thus facilitate the implementation of an HPV-based screening program.^{2,16,17,127,427} The most widely studied triage test in this situation is cytology.⁴²⁷ Other triage tests are being studied, including genotyping for HPV16 and other high-risk HPV types, as well as identifying biomarkers of disease progression such as expression of p16^INK4a and Ki-67, or DNA methylation.⁴²⁷ Note that these other triage tests are outside the scope of this CADTH Optimal Use project.

The authors of a paper on the Canadian Cervical Cancer Screening Trial state that appropriate triage of high-risk HPV-positive test results to colposcopy is necessary to identify those at immediate risk and to prevent undue harm to those at low-to-moderate risk.¹²⁷ The authors concluded that appropriately balancing the benefits of HPV-based primary screening with informed management recommendations is important to the success of this screening strategy and its widening utilization.¹²⁷

Funding Models

Aligning screening recommendations with funding models could reduce over-screening because HCPs will only be paid for sample collection at appropriate intervals and for eligible patients.^82,414,428 A well-organized and monitored program, in which primary HPV tests taken outside the program are not reimbursed by the government, could help minimize the number of tests taken outside the program, thereby limited the level of over-screening.⁸²

Registry System

The benefits of a registry are discussed throughout this implementation section, and it is also thought to be a facilitator to preventing over-screening and overdiagnosis.

PAHO and WHO state that the information system can be based in each health facility or centralized in an office that serves several health facilities.⁴¹⁸ During the consultations for this report, some stakeholders expressed that a national registry with supporting software would be needed. They advocated that a single registry is needed to communicate results to the screening participant, all her HCPs, and laboratory staff, and to keep track of screening history and eligibility intervals. This kind of system would prevent someone from going to a different clinician to obtain screening if denied by her primary care provider (i.e., because she is not due for a screening appointment), and therefore it could help prevent overdiagnosis and overtreatment.

“A national registry would be ideal because people move a lot. Having a national registry or registries that are well connected would prevent unnecessary testing.” (Dr. Marc Steben: personal communication, 2017 December.)

Encouraging Stewardship

Another facilitator that could mitigate overdiagnosis is to encourage stewardship of appropriate screening practices. For example, Ontario’s reimbursement guidelines encourage physicians to consider whether it is professionally appropriate to provide screening services in excess of the limit and to have discussions with patients about why the test is not medically indicated and potential risks associated with unnecessary medical interventions.⁴²⁹

The Pan-Canadian Cervical Cancer Screening Network recommends that laboratories need to have a stronger role in being custodians against inappropriate testing and need to be able to send that message back to providers.⁴¹⁴ However, other experts, while acknowledging that labs have a role in promulgating screening guidelines, feel that the primary custodian role should remain with HCPs because, once a specimen arrives in the lab, it is difficult to refuse testing for medical, legal, client, ethical, and practical reasons. Labs frequently receive test specimens without any knowledge of the clinical situation (e.g., if the specimen is from a high-risk individual or if the test is being used for another form of clinical management, such as a test of cure) (Dr. Terence Colgan: Discipline Head of Histopathology, LifeLabs Ontario; Professor Emeritus, University of Toronto; Former Head of Gynaecological Pathology and Cytopathology, Mount Sinai Hospital, Toronto: personal communication, 2017 January 17).

Education on Overdiagnosis

Providing information on overdiagnosis and over-screening to the public could help ensure adherence with recommended screening frequencies.⁴³⁰ Also, providing information on overdiagnosis in decision aids could increase the number making an informed choice,³⁶¹ as it has been stated that a participant should be free to accept or refuse testing.⁴¹⁹ The Ethics Review provides further information and analysis regarding informed choice and test refusal.

HPV Vaccination

The increasing prevalence of HPV vaccination in the population is anticipated to lead to fewer HPV infections and therefore fewer HPV-positive screening results and fewer cytologic abnormalities. This has the potential to reduce the overdiagnosis and overtreatment of screening participants.^2,84,411,424 In other words, the increasing prevalence of HPV vaccination may be a facilitator that could counteract the potential barrier of overdiagnosis and overtreatment. Lower population prevalence of HPV as vaccinated cohorts move through screening ages may necessitate reconsideration of the need for population-based screening programs, as opposed to opportunistic screening programs focused on the unvaccinated or otherwise at risk. Supporting access to vaccination and supporting the acceptance and uptake of the HPV vaccine could be considered as part of the implementation strategy for HPV-based primary screening.

Staggered Rollout

During the consultations, it was suggested that a staggered rollout (where certain age groups are screened one year and others the following year, etc.) could be a way to manage any initial spikes in referrals to colposcopy, as opposed to screening the whole eligible population at once. In Italy, where many regions have adopted HPV-based primary cervical cancer screening, most cervical screening programs chose to transition to HPV-based testing over the course of a few years to allow for adjustment to the volume of activity in screening.⁴³¹

Human Resourcing in Cytology

Reduced cytology workload and, therefore, job losses for cytologists, has been identified as a concern related to implementing HPV-based primary screening.^2,432 In Canada, molecular testing for HPV would be performed in a microbiology lab and automated — it would not be performed in a cytology lab by cytologists. As a result, it is believed that there would be significant job losses for cytologists. (Dr. Terence Colgan: personal communication, 2017 January.)

It is not certain to what extent job losses might occur, but fear about job losses is an implementation barrier, and its effects are already being felt in Canada (even before a decision regarding HPV-based primary screening has been made). During the consultations for this report, it was heard that cytologists (cytotechnologists and cytopathologists) see the change to HPV-based screening happening in other countries and assume it will eventually be implemented in Canada. “Students are afraid of going into this profession because they anticipate HPV testing will replace cytology testing for primary screening, and that computer algorithms will replace human interpretation of samples.” (Dr. Manon Auger: personal communication, 2017 November.) In recent years there has been a reduction in the number of Canadian schools and programs providing cytology training. (Dr. Peter Bridge, Academic Chair, Medical Laboratory Sciences, The Michener Institute of Education at UHN, Toronto: personal communication, 2018 May 22; and Dr. Manon Auger: personal communication, 2017 November.)

During the consultations, it was heard that there is a shortage in the cytotechnologist and cytopathologist workforce in some Canadian jurisdictions. “Historically, it has been a struggle to recruit cytotechnologists as class sizes are small and there is no training program in the province. The greatest challenge has been to fill temporary postings such as maternity leaves.” (Brian Timmons, Provincial Technical Director Laboratory Services, Health PEI: personal communication, 2017 December 13.) “There is also attrition in the cytology workforce, as many people are retiring.” (Dr. Manon Auger: personal communication, 2017 November.)

“Hence, it may be more of a question of whether our current method of primary screening with cytology is sustainable.” (Dr. Robert Lotocki: personal communication, 2017 March.)

Throughout the consultations for this report, concerns were heard that the cytology workforce is becoming too reduced to meet current and potentially future demand. If a triage test is adopted that involves cytology testing, there will be a need for cytology staff. Furthermore, while cervical cytology tests are a type of gynecologic cytology, non-gynecologic cytology is usually done in the same lab, so the need for cyto-technical staff will continue to exist in these labs. (Dr. Robert Lotocki: personal communication, 2017 March.)

Concerns were also heard about the effect on competency. Small laboratories may not have the volume of samples needed for cytotechnologists and pathologists to maintain competency. (Dr. Kristen Mead, Program Medical Director, Pathology, Health PEI: personal communication, 2017 December 13.)

Human resourcing issues, including job losses and challenges with staff retention and recruitment, are also expected or are already being seen in countries that are switching from cytology to HPV testing. “In England, job losses for cytology screeners are predicted if the option to centralize HPV/cytology laboratories is taken forward — many people could potentially be made redundant or will need to move to a different specialty.” (Janet Rimmer, Senior Implementation Lead, HPV, England: personal communication, 2017 August 23.) However, the cytology role will remain important in England because cytology will be performed to triage HPV-positive samples. “It is important to note that currently there are not enough cytology screening staff in England to maintain turnaround time standards with primary cytology screening. Abnormal reporting rates are expected to remain similar at least in the first few years after implementing primary HPV testing, and there will be a need for pathologists and consultant biomedical scientists to assess and report the abnormal cytology samples. It may be a challenge to ensure sufficient staff, because fewer people may want to pursue this career path.” (Janet Rimmer: personal communication, 2017 August.)

In New Zealand, where planning is underway for a change to HPV-based primary screening,⁴³³ uncertainty about job security has caused some laboratory staff to leave. Concerns have been raised that no new trained staff are available, and that it could be difficult to maintain adequate levels of skills and services. These concerns primarily relate to cytology staff, but worries were also noted about potential pathology and histology staff shortages.⁴³⁴ In response to these concerns, the National Screening Unit within the Ministry of Health is undertaking research to better understand laboratory and staff requirements leading up to and after changing to primary HPV-based screening. The National Screening Unit has also committed to working closely with laboratories and staff to identify the best ways to support the workforce before any changes take place.⁴³⁴

Retraining, expanded roles, and career transition opportunities for laboratory staff could facilitate the acceptance and implementation of an HPV-based screening system. There is the potential for growth in new skill development opportunities, such as molecular training.^414,435 In the Netherlands, where HPV-based cervical screening is being introduced, cytotechnologists are moving to careers in histology, molecular pathology, immunology, and rapid on-site evaluation (ROSE) (Lia Van Zuylan-Manders, Team Leader Cytology, Radbound University Nijmegen Medical Centre, Netherlands: personal communication, 2017 September 8). In England, training tailored to primary HPV-based screening is being developed for laboratory staff for delivery by dedicated training centres (Janet Rimmer: personal communication, 2017 August). In the US, many cytotechnologists are already practising with expanded roles; for example, performing ROSE for specimen adequacy of fine needle aspirations (FNA).

In Canada, there are continuing education courses available to enable current cytotechnologists to upgrade their knowledge and skills for a renewed work environment. However, retraining is not without its challenges. “A protectionist attitude from some staff currently in the laboratory environment (pathologists, cytotechnologists, as well as other laboratory technologists) limits the acceptance of cytotechnologists in delivering additional skills.” (Dr. Catherine Brown, Professor and Clinical Liaison Officer, The Michener Institute of Education at UHN, Toronto, personal communication, 2018 June 25.) Also, retraining and relicensing take considerable time and effort and require additional resources that may not be readily available.⁴³⁶ “Retraining and career transition might not be feasible for many current cytotechnologists.” (Dr. Catherine Brown: personal communication, 2018 June.)

For new students beginning training, new core competencies (e.g., histology, molecular) endorsed by the Canadian Society for Medical Laboratory Science have been added to training curricula. Newly trained cytotechnologists completing training from 2017 onward will be educated in histology sample preparation; recognition of normal and abnormal tissue architecture; immunohistochemistry/immunocytochemistry technique and basic analysis; ROSE for FNAs; kit-based molecular testing for high-risk HPV, estimated Glomerular filtration rate, and alk genes; and fluorescence in situ hybridization techniques and basic analysis. These graduates will be eligible to become licenced in cytology, histology, and molecular work and may be able to perform expanded functions within the lab.^436,437

While the curriculum changes are promising for new graduates, the loss of some older cytotechnologists — those who are the most skilled and experienced — might still occur. “The expanded scope of practice will produce many ‘jacks of all trades,’ but we will miss the ‘masters.’ It takes many years of experience to become an excellent cytotechnologist and cytopathologist. We need to sustain those currently trained so that our field is not decimated by mass exodus and layoffs.” (Dr. Catherine Brown: personal communication, 2018 June.)

Centralization of Laboratories

Current laboratory structure and workflow could pose a challenge to the implementation of an HPV-based screening strategy. Because the HPV test is a molecular test, and because a change from cytology to HPV-based primary screening would likely lower cytology sample volumes and throughput, the centralization of labs (reduction in number of small labs processing samples) may assist in the adjustment to the different sample volumes and thus facilitate a change to HPV-based screening. This configuration change is under consideration in England and has been adopted in the Netherlands when transitioning from cytology-based to HPV-based screening. There are accompanying logistical challenges; for example, with fewer, more centralized labs, there is a challenge to ensure that samples arrive to the labs on time, considering the greater distance they might need to travel. (Janet Rimmer: personal communication, 2017 August.) “Another challenge is asking staff members to move to a new location. In England, the option being considered is a reduction from approximately 50 labs to 10–15 labs. These 10 to15 labs will be located across England and each one will provide both HPV testing and cytology testing. It will be important to ensure that each lab is sufficiently sized so that there are sufficient numbers of cytologist screeners working at all times (i.e., even when some staff take vacation).” (Janet Rimmer: personal communication, 2017 August.) In the Netherlands, there was a reduction from approximately 35 screening labs to five labs (one for each region). One of the main challenges was the lengthiness of the process — with the selection of laboratories lasting from the fall of 2015 to June 2016. (Lia Van Zuylen-Manders: personal communication, 2017 September.)

It is not clear if centralization of labs would be an appropriate strategy in Canada, considering its geography, population distribution, and health system structure. Each jurisdiction has unique factors to consider. Concerns have been raised about centralization of labs, such as loss of connectivity and communication between cytology and histology (biopsy) testing. “Currently, most cytology labs are in the pathology department — even if they are not housed in the same building, it is possible to walk over to talk to your colleagues.” (Dr. Manon Auger: personal communication, 2017 November.) “The problem with centralization is that biopsies would be performed elsewhere, because it is unrealistic for biopsies to be all done in the same lab. Biopsy and cytology separation could potentially be dangerous as it is suboptimal to look at samples out of context.” (Dr. Manon Auger: personal communication, 2017 November.) There are also concerns about the impact of centralization on non-gynecologic cytology. “The demand for non-gynecologic cytology is growing, but having fewer labs and fewer cytologists in general will have a negative impact on non-gynecologic cytology.” (Dr. Manon Auger: personal communication, 2017 November.)

Laboratory Costs of Transitioning to HPV-Based Screening

Capital costs of purchasing HPV testing equipment and reagents will need to be considered.⁴¹⁸ However, some of the equipment may already be in place because several jurisdictions in Canada are currently doing HPV triage of cytology-positive cervical samples.²² It is also expected that some of the costs will decrease with increased volume and vendor competition (Dr. Robert Lotocki, Manitoba PCCSN member: personal communication, 2017 March). Group purchasing and competition among manufacturers could result in lower costs for HPV testing equipment and reagents.⁴³⁸

Jurisdictions that have not yet switched to liquid-based cytology will need to do so, which will incur costs (Dr. Robert Lotocki, personal communication, 2017 March). Building modifications may be required in laboratories housing the new equipment, and the funding for those modifications will need to be in place (Brian Timmons: personal communication, 2017 December).

Cost issues are addressed in more detail in the Economic Analysis portion of this report.

Internet Technology Systems

Throughout the consultations, a common topic that emerged was the need for new or modified Internet technology (IT) systems that are more comprehensive in tracking and linking data. With the added complexity of using different testing technologies (e.g., HPV molecular test with cytology triage, instead of cytology alone), IT systems were identified as important facilitators to implementation in the laboratory sector if HPV-based screening is adopted. Current systems may be a barrier to implementation. For example, in Prince Edward Island, there are concerns about linking multiple laboratory test results related to one patient.

“We have an electronic health record (EHR) system here, but the reporting formats vary depending upon the discipline; for example, microbiology and pathology are in two very different sections. In our operations, HPV testing would be performed by the Microbiology laboratory. Reporting systems may have to be modified to ensure the continuity of results between the HPV testing lab and Pathology where the cytology information is housed.” (Brian Timmons: personal communication, 2017 December.)

“A pathologist should be able to look at the electronic medical record and easily see the patient’s screening history, HPV results, colposcopy results, etc.” (Dr. Kristen Mead: personal communication, 2017 December.)

Similar needs for IT systems were identified in Quebec. “It’s important to have one registry that ties all the test results together. It needs to match the molecular results to the cytology results and to the histology results. All the data needs to be integrated, and the test results need to be linked to patient recall. Money will be needed from the province for this IT system because if it’s left up to individual institutions, they will choose whatever is cheapest rather than what is optimal.” (Dr. Manon Auger: personal communication, 2017 November.)

The experience of other countries may be valuable to Canadian stakeholders if there is the decision to implement HPV-based screening. “The Netherlands uses a fully automated system for tracking results called SCREEN IT. This system transfers results from laboratories, to screening programs, and then to GPs. The results are sent automatically, and the system is working well.” (Lia Van Zuylen-Manders: personal communication, 2017 September.) In England, there is a plan to implement a new call/recall IT system in 2018. The system will invite women and inform them of their results once received from the laboratory. The collection and reporting of statistics is being done separately, with data published for all of England. (Janet Rimmer: personal communication, 2017 August.)

The Cancer Research UK group states that “[c]ommitment to and introduction of a fully-funded IT system must be included as part of the rollout plans for HPV primary tests but should not delay its introduction.”⁴¹³

Longer Intervals and Later Start Age May Cause Patient Participation Drop-Off

The reduced frequency and later start age may be met with reluctance.^430,439,440 In Australia, where HPV-based screening is being introduced, more than 70,000 people signed an online petition to oppose the changes to the cervical screening program, and it is speculated that some of the opposition was based on potential misunderstanding of the rationale for the change, as well as misunderstanding of the effectiveness of screening and the role of HPV as a cause of cervical cancer.⁴⁴⁰ In an opinion article, researchers in Australia stated that a reasonable message to take away from the petition was that communication and consultation have not been sufficient or effective.⁴⁴⁰ In England, the introduction of a later start age for screening was also not well received — it was perceived by some as “rationing care.” A decade later, some people are still exhibiting their discontent, and national media headlines can be seen such as, “Denying Young Women Smear Test is a Disgrace.”⁴²⁵

In the Canadian context, participation in the Ontario Cervical Screening Program decreased by 5% between 2009 and 2014.⁴³⁹ This decrease coincided with the introduction of a longer interval between screens from once a year to once every three years. Before the guideline change, participation had increased in every measurement period since 2003.⁴³⁹ In the HIV-positive population in Ontario, cervical cancer screening rates also dropped in 2012 and 2013, even though annual screening continued to be recommended for this patient population.⁴⁴¹ One possible reason is that there was a delay in authorizing an alternate billing code for those who were HIV-positive or otherwise immunocompromized to allow for continued annual screening (a 10-month delay from when the original billing disincentive was introduced for the general population in January 2013).⁴⁴¹

In a survey of participants in a clinical trial in British Columbia, the intention to attend HPV-based screening dropped once participants were advised of the extended screening interval and later start age.⁴³⁰ It has been suggested that comprehensive education to improve the understanding of the rationale for a change from cytology to HPV testing (and thus the change in screening interval) may mitigate that potential barrier.⁴³⁰

Patient Education About Cervical Cancer Screening in General

Patient education has been found to increase participation in cervical cancer screening performed by Pap test.^442,443 There is reason to believe that this would also be the case for an HPV-based screening program.

Patient Education About HPV and HPV-Based Screening

Patient communication and education could facilitate the implementation of HPV testing, both in the clinic and through self-sampling.^{2,221,377,418}

One of the experts consulted recommended that “communication and educational tools should be developed well before any implementation because they will require input and review by various stakeholders, including clinicians, policy-makers, and screening participants. These tools should exist in various formats (paper handouts, public service announcements, screening program websites, social media, etc.). It is anticipated that a multi-faceted and well-planned approach will have greater reach and improve the chances that stakeholders understand why cervical screening is changing, and therefore, accept these changes to a public health approach that has been implemented for decades.” (Laurie Smith, RN(C) BN MPH, Research Manager, HPV FOCAL/HPV Related Diseases, BC Cancer/Women’s Health Research Institute: personal communication, 2017 September 8.)

Having educational materials available in various formats has been further supported in the literature.^271,444 Other ways to facilitate uptake could include developing materials for varying literacy levels and translating materials into many languages.^418,445 The Pan-Canadian Forum on Cervical Cancer Prevention and Control recommends that education should be specific to age, gender, sexual orientation, and culture.⁴⁴⁵

Vulnerable populations, such as patients who are immunocompromized, may need tailored communication. “Often vulnerable patients are too busy dealing with other pressing health issues to think much about cancer screening. It’s important to provide communication and equal access to health services to vulnerable populations such those who have chronic illnesses and to new immigrants and refugees.” (Dr. Marc Steben: personal communication, 2017 December.)

Patient education on HPV could be facilitated by using many modes of outreach, including by HCPs, teachers, youth counsellors, public health educators, and the media.^418,445

The Pan-Canadian Forum on Cervical Cancer Prevention and Control further recommends that the content of communication and education tools be developed in consultations with clinical experts and with input from the target audience and the HCP who will be disseminating them.⁴⁴⁵

Information about the types of HPV, its transmission and prevention, the link between HPV and cervical cancer, and the importance of cervical cancer screening could be a facilitator to implementing an HPV-based screening program.^418,445,446 Destigmatizing HPV infection and emphasizing its high prevalence in the population (potentially describing it as the “common cold” of STIs⁴¹⁴) have been identified as some of the most important messages to convey to patients.⁴⁴⁶

Explaining the differences between cytology testing and HPV testing, and explaining the naturally slow progression of the disease, may increase comfort levels regarding a potentially later start age and extended screening interval.⁴⁴⁶ Because a later start age and extended screening interval may be perceived as a cutback to health care, experts have emphasized the importance of messaging that clearly outline the scientific reasons for the change in programs.^2,430

Community Education

Community education has been shown to be an important facilitator to encouraging participation in screening.^214,221 Many people still have limited knowledge about HPV; it has been proposed that HPV information should be provided to all Canadians, not just those eligible for screening.^214,445 Community education could help destigmatize HPV infections and could help the public understand and accept changes to the cervical cancer screening strategy.^221,425 In an opinion piece,⁴⁴⁰ researchers in Australia stated that “meaningful public engagement and communication are neither easy nor cheap, but shying away from them is not an acceptable response.” The PAHO/WHO manual recommends involving mass media to promote messages about HPV testing because this can help obtain a greater commitment from the public and health providers when the program is rolled out.⁴¹⁸

Other countries that are implementing HPV-based cervical cancer screening have provided information online about the change. For example, the UK National Screening Committee developed questions and answers that are available on their website.⁴⁴⁷ Australia’s National Cervical Cancer Screening Program website provides information about the new test, answers common questions about HPV and cervical cancer, and features an animated video.⁴⁴⁸ New Zealand’s National Cervical Screening Programme has also provided information online⁴³³ about its plans to introduce HPV testing for primary screening and it has developed frequently asked questions.⁴⁴⁹

HPV Vaccination and its Link to Screening Participation

Cervical cancer screening (via cytology testing) has been found to be more common among HPV-vaccinated participants.⁴⁵⁰ The authors speculate that people willing to pay for the vaccine may be more health conscious and thus also participate in screening more than those not willing to pay for the vaccine.⁴⁵⁰

All jurisdictions in Canada are currently offering school-based HPV vaccination to girls, and 10 provinces have begun or announced a school-based HPV vaccination program for boys.²² HPV vaccines are also available in all provinces and territories outside of the school-based programs, but they usually must be requested and paid for by the patient or their private insurance.²² Patient counselling on HPV vaccination could be an opportunity to provide counselling on HPV-based screening, and vice versa.⁴⁵¹ “Women getting the vaccine are generally more aware about prevention. Counselling on cervical cancer screening and prevention can be combined with vaccine education.” (Dr. Marc Steben: personal communication, 2017 December.) Many clinical experts state that it is important for the vaccinated population to continue cervical cancer screening, and this is a message that should be included in communication materials.^{416,450–452}

Invitation and Recall Letters

Invitation and recall letters have been shown to increase awareness and participation in screening.^{439,442,443,453,454} The literature notes some key findings on how to further increase participation through invitation and recalls, including sending the invitations by mail, sending a reminder letter after an invitation letter, having the letters signed by a medical director or the patient’s physician, and including customized messages (e.g., date of the last test).⁴⁵³

The Pan-Canadian Cervical Screening Initiative Network recommends that optimal correspondence would include an invitation to participate in screening, notification of screening results, recall notice for next screening, and follow-up on abnormal results.⁴⁵³ The network recommends the implementation of all these correspondence elements across Canadian cervical cancer screening programs, but that each province or territory should conduct their own prioritization exercise to determine the approach and correspondence elements appropriate to them, considering capacity, resources, and overall program goals. The network also recommends that letters should be reinforced and supported by other strategies, including phone calls, electronic communication, health promotion activities, mass media campaigns, clinician-directed strategies, and targeted activities for those who are more difficult to reach.⁴⁵³ While these strategies are not unique to HPV-based screening, they may be relevant, particularly because of the extended screening interval.

HPV Self-Sampling

Self-sampling for HPV testing may be a facilitator to screening participation. In particular, studies have shown that self-sampling increases screening participation rates in those who are underscreened or never screened.^{20,377,443,455–457} As found in the Patient Preferences and Experiences Review and in the literature identified in this Implementation Issues Review, self-sampling can also be more appealing to individuals who fear speculum examination conducted by an HCP or who have concerns about privacy and modesty.^444,458,459 A self-sample kit that can be used at home offers the benefit of increased convenience and eliminates the need to book time off work, arrange for childcare, or travel to a clinic.^20,221,377 Attitudes toward self-sampling tend to be positive with high acceptance or willingness to try this method.^444,455,460

In the Netherlands, those not responding to the screening invitation will receive a self-sampling kit for HPV testing and those with a high-risk HPV+ result will be referred to their physician for sample collection for cytology triage.¹⁶ However, studies have shown that automatically mailing kits may result in wasted kits, so another strategy might be to allow those who don’t attend appointments to request kits (or “opt-in”). The opt-in approach could reduce waste and save money, but it might result in fewer people using the self-sampling kits because it creates an additional step and requires additional effort for the participant.^20,457

One approach tried in Denmark was to use opt-in HPV self-sampling using paper, telephone, webpage, and mobile app methods for communicating with screening participants.⁴⁵⁷ Another alternative tested in France for increasing participation in non-attenders was to implement self-sampling alone, without invitation and recall letters.⁴⁵⁶

In Canada, there are mixed opinions among HCPs and policy-makers about whether self-sampling should be implemented for only underscreened populations or for the whole eligible population. Self-sampling may be appealing to all screening candidates because it provides flexibility, but there are concerns about decreased diagnostic performance (while there is some evidence showing similar performance between clinician- and self-sampling for some tests using certain sampling techniques, there is a lot of heterogeneity between studies and firm conclusions remain unclear⁶⁷) and missed opportunities for clinicians to engage in discussions with patients about other health issues.⁴³²

As with invitation and recall letters, there are logistical issues to consider when implementing self-sampling, such as how to best distribute and keep track of self-sample kits.⁴²⁶ A possible option to consider is the use of a fulfillment house, which is a business specializing in providing services related to mailing.⁴⁵³ Fulfillment houses are used by some cervical cancer screening programs for the mass mailing of invitation and recall letters. Using a fulfillment house obtained through competitive procurement process can be more efficient and cost-effective than in-house mailing.⁴⁵³

Mobile or Integrated Screening

Mobile screening centres have been launched as a way to facilitate participation in cancer screening. In Ontario, a 45-foot-long bus called the Screen for Life Coach goes to workplaces and other locations in the community to provide cervical cancer screening as well as breast and colorectal cancer screening and education. Registered nurses perform the sample collection for the cytology test on the bus. Mammograms are also performed on the bus, and participants are given a take-home fecal occult blood test for the colorectal cancer screen. Time on the bus is 20 minutes per person. Screen for Life Coaches operate in the Hamilton area^6,461 and in Northwestern Ontario.^439,462

Mobile services could also be a possible way of reaching underscreened populations. Authors of a study on the barriers to cervical screening among sex workers in Vancouver report that contact with outreach services that provide cytology tests (e.g., street nurses, mobile outreach) increased the odds of testing by 35%.⁴⁶³

Another group of study authors suggest integrating cervical and breast cancer screening services. In this service delivery model, cervical cancer screening performed by a trained HCP could be offered in breast cancer screening sites with active scheduling of appointments.⁴⁶⁴

On-Site Colposcopy Services

Having on-site colposcopy services has been seen to facilitate adherence.⁴⁶⁵ Colposcopy follow-up after abnormal screening results is an important component of cancer screening programs, but nonadherence, defined as failure to attend the recommended colposcopy, is common. In 2009, a sexual health clinic in downtown Toronto, Ontario, established an on-site diagnostic colposcopy service that also includes patient counselling by telephone and individualized supports. The authors reported that this model of care reduced colposcopy nonadherence by two-thirds.⁴⁶⁵

Difficulty Adapting to a Change in Practice

Guidelines that recommend reducing interventions can be difficult for clinicians and the public to understand and accept.^428,466,467 One paper states that, although providers are quick to adopt new tests, they are slow to adopt longer screening intervals. The authors of this paper speculate this resistance could be the result of pre-graduate training, disincentives due to loss of reimbursements with longer intervals, and a lack of well-organized information systems to track screening history and ensure patient recall.⁴¹⁶ In one survey, physicians expressed concern that women would not come for annual exams if cervical cancer screening was not offered and concern that extended intervals would lead to inadequate screening.⁴⁶⁷ A longer screening interval reduces the number of opportunities for clinician-patient interaction and provides fewer opportunities to screen for other STIs and to discuss contraception options or other sexual health concerns.⁴³² Clinicians may be resistant to this potential change in the clinician-patient relationship and they may find it difficult to adapt their practices to actively schedule sexual health wellness appointments.

Authors of the VASCAR study in Montreal reported that the learning curve for some health care workers when adopting HPV-based primary screening was longer than expected.⁴¹⁰ Despite providing diagrams, oral presentations at Grand Rounds, and written recommendations for risk management after test results, there were 3,414 protocol violations reported in this study (involving 11.7% of the 23,739 women who were screened). Most protocol violations took place in the first year, and the most common protocol violation was a conventional cytology test being conducted at the initial screening visit instead of the recommended HPV test (9.3% of those who were screened).^410,411

Lack of Time and Resources

A survey of primary care physicians in British Columbia asked about cervical, breast, colorectal, prostate, and other cancer screening and identified several barriers including physician time constraints, lack of financial compensation to discuss screening, and having patients with multiple health concerns.⁴⁶⁸ An Ontario study found that some doctors may not offer cervical cancer screening to those with intellectual and developmental disabilities because of the extra time required to provide education and because of a false perception that these women are not sexually active.⁴⁶⁹ The authors of the survey in British Columbia concluded that the study highlights the need for more physician education on screening programs, referral criteria, follow-up process, and screening guidelines.⁴⁶⁸

One strategy attempted in Ontario was to provide financial bonuses for physicians. However, the cervical screening rate did not change significantly from year to year before or after the incentives were introduced. The lead author stated that governments around the world are experimenting with paying doctors extra to improve the quality of care but there’s little evidence that this strategy works.⁴⁷⁰

In terms of HPV-based screening, clinicians in the UK have acknowledged a lack of confidence in explaining HPV infection and sexual transmission.⁴⁷¹ Conversations about HPV were described as “awkward,” “a can of worms,” and “a minefield.” These clinicians acknowledged a need for more education in the science relating to HPV and cancer and for training in communicating sensitive information to patients.⁴⁷¹

Health Care Provider Characteristics

Certain HCP characteristics, such as gender or being trained outside of Canada, may influence cervical cancer screening practices.

Some studies report that female providers have patients with higher screening participation rates.^464,472 It is speculated that the female physician approach to care delivery is different because they may have a stronger orientation to preventive care and adherence to guidelines,^467,472 and female physicians may take on a lighter workload so that they can spend more time with individual patients.⁴⁷² Female physicians also report feeling more comfortable with performing cervical cancer screening than male physicians.⁴⁶⁸ Patient preferences may also factor in to this poin;.^202,208,473 this is described in more detail in the Patients’ Perspectives and Experiences section of this report.

One study in the US found that practitioners in group practices were more likely to follow both vaccination and screening guidelines than those in solo practices.⁴⁶⁷ The authors speculate that perhaps the reason for this discrepancy is that physicians in group settings have better access to new information and sharing of knowledge among colleagues, and that financial pressures may also influence practice differently in solo and group practices.⁴⁶⁷

In another study, physicians who attended medical schools in the Caribbean, Latin America, the Middle East, North Africa, South Asia, and Western Europe were less likely than those trained in Canada to screen their patients for cervical cancer.⁴⁷⁴ The lead author says this finding may reflect differences in what is emphasized in medical school curricula around the world. The author recommends that physician characteristics should be considered when designing physician-targeted interventions for cancer screening.⁴⁷⁴

Clinician Education About Cervical Screening in General

Education tailored to HCPs and their specific needs can help address gaps in training and knowledge, and can help optimize cervical cancer screening practices, regardless of the screening technology being used.⁴⁷⁵ Many organizations are already involved in providing education and resources; for example, Cancer Care Ontario offers continuing medical education modules and develops a suite of tools for primary care providers and other specialist audiences to facilitate knowledge transfer and increase screening according to guidelines. Their tools are disseminated to providers primary though their professional organizations (e.g., the Ontario Medical Association and the Nurse Practitioners’ Association of Ontario) and include clinical guidelines summaries, decision support tools, handouts, and e-bulletins.⁴⁷⁶

Clinician Education and Training Specific to HPV-Based Screening

Education and professional development opportunities could be made available for clinicians to encourage acceptance and participation in a new screening strategy.^2,445,466 It has been recommended that, to enhance engagement of primary care providers, it would be helpful to identify the gaps in HPV knowledge. This could be achieved through a baseline survey of practitioners.⁴¹⁴ Practitioners should be aware of HPV and the role it plays in cervical cancer, the disease etiology, and that this is an area of evolving knowledge.⁴¹⁴ If there is a change to HPV-based screening, practitioners will need to know how to manage HPV-positive results, abnormal cytology triage results, and how to counsel patients and their partners.^2,414,468

One study found that knowledge translation workshops can be an effective approach for communicating evidence on HPV-based screening to colposcopists.⁴⁶⁶ Several organizations across Canada, including CADTH, have the capacity to provide these kinds of knowledge translation opportunities.

In England, where HPV-based screening is being implemented, e-learning formats are in development for sample takers. Similar e-learning tools are being developed for colposcopy staff to explain new clinical management pathways. The e-learning format was selected because of the number of staff and locations needing to be reached. (Janet Rimmer: personal communication, 2017 August.)

“Multi-media education for clinicians is best. Young doctors might prefer e-platforms while older doctors might prefer a phone number they can call.” (Dr. Marc Steben: personal communication, 2017 December.)

Because primary care practitioners play a central role in explaining and recommending screening to patients, education for them will in turn improve education for their patients.^377,446,475 Having communication materials prepared for clinicians that they can share with their patients could save clinicians time in explaining changes to screening. In the UK, clinicians mentioned that it would be particularly useful to have a written handout to give to patients.⁴⁷¹ A group of UK researchers developed and field-tested HPV consultation guides, including information handouts for patients diagnosed with HPV-related cancer.⁴⁷¹

Clinicians might not be prepared for certain questions, so providing question and answer tools can help facilitate conversations with patients (Laurie Smith: personal communication, 2017 September). In addition to explaining HPV testing for primary cervical cancer screening, clinicians will need to be able to explain the meaning of positive results and the steps required for follow-up.^2,414,418 Patients who learn they are HPV-positive may feel anxiety, shame, or anger, and clinicians should be prepared to explain the prevalence of HPV in the population and stress that having HPV is no reason for shame. Those who are HPV-positive may have questions about whether to tell their sexual partner, if HPV can be treated, and how to avoid re-infection.⁴⁴⁶ The full list of questions received from patients during the FOCAL trial, including responses, is available in the FAQ section of the BC Cancer Agency website.⁴⁷⁷

Recently, the International Centre for Infectious Diseases produced a booklet⁴⁵¹ for HCPs suggesting ways in which to counsel patients about HPV testing and test results. It includes sections on HPV testing for cervical cancer screening, HPV transmission, and vaccination.

“For clinician education to be effective, we need something very structured. We need not only counselling tools but also a dissemination and education strategy.” (Dr. Marc Steben: personal communication, 2017 December.)

In many Canadian communities, sample collection for cervical cancer screening is performed by nurses, while community education and promotion is provided by other health care professionals. Therefore, training and education would need to be offered to a range of health care practitioners, including physicians, nurses, and community health workers.⁴¹⁸

Access to Experts

Access to experts in the field of HPV-based cervical screening who can answer clinician’s questions regarding HPV testing and cervical cancer may be a facilitator to implementation.^414,466

The French National Agency for Accreditation and Evaluation in Healthcare recommends that a cancer screening program should include coordination between clinicians (general practitioners, specialists, nurses, and pharmacists), and that their job is to encourage screening candidates, technicians, and operators.⁴¹⁹

Databases and Internet Technology Solutions for Health Care Providers

User-friendly databases can facilitate clinician participation in new cervical cancer screening pathways because they can make it easier for clinicians to keep track of patients and results.

An example of a large electronic database already in place is the Screening Activity Report (SAR) for physicians, developed by Cancer Care Ontario. It was evaluated in 2014 and a modest association was found between using the SAR and increases in screening participation (cervical screening using the Pap cytology test, as well as breast and colorectal cancer screening).⁴³⁹ The SAR lets physicians know which of their patients have been screened, which ones are overdue for screening, and which ones need follow-up after abnormal test results. It also enables them to compare their performance with others within their regions and the province.⁴⁷⁶ Cancer Care Ontario is working to integrate the SAR with other eHealth platforms, such as electronic medical records.⁴³⁹ Although the SAR is not specific to HPV-based screening (currently it is being used for cytology-based screening), it serves as an example of a facilitator that helps clinicians participation in screening.

Clinical Practice Guidelines

Clinical practice guidelines can also be a facilitator for HCPs.

“Given the improved sensitivity with HPV testing, an extended screening interval will occur for routine screening. Cervical screening by a clinician is often an opportunity for the clinician to review other medical issues with patients. As a result, clear guidelines on HPV primary testing and follow-up, as well as recommendations for other STI testing, can support clinicians in decision-making and can counteract the potential loss of opportunity to screen for other STIs and ensure women still attend for visits with their providers for other medical issues as needed.” (Laurie Smith: personal communication, 2017 September.)

Socioeconomic Status

Low income and low socioeconomic status have been shown to be a potential barrier to cancer screening. It has been speculated that lack of access to transportation, childcare, or the inability to take time off work are factors to low screening participation in those with lower socioeconomic status.^{202,416,441,459,464,478,479} Cervical cancer screening participation has also been found to decrease with advancing age.^464,480

Ethnicity and Cultural Barriers

Participation in screening may vary by ethnic or cultural group. For example, screening participation has been found to be low among Canadians from Muslim-majority countries,^475,481,482 and beliefs about cancer and the lack of culturally safe or appropriate programs and services have been found to be barriers for Indigenous peoples.^202,259,473 Some of the varying screening rates have been reported in the Clinical section of this report and some of the reasons that individuals who belong to those groups have given for not participating in screening have been outlined in the Patients’ Perspectives and Experiences section of this report.

Systemic Barriers

Systemic barriers to screening include restrictions such as remote geographical location, shortage of HCPs, high staff turnover, and lack of tracking systems for follow-up.^473,483 For example, Muslim immigrants in the Greater Toronto Area have reported difficulties accessing female physicians, language barriers, long wait times, and lack of transportation.⁴⁴⁴

In summary, while barriers related to socioeconomic status, ethnicity, culture, and the health care system are not unique to HPV screening, they are important to note with respect to implementing a new or different screening program.

Culturally Appropriate Educational Materials

Culturally appropriate education materials have the potential to be facilitators to participation in screening programs.^{221,443,473,479,481} Creating culturally appropriate education and programming could be done by being intentional and responsive to a community’s cultural beliefs regarding cancer and its prevention and treatment.^444,473,484 It has been suggested that HCPs establish trusting relationships with their patients and be willing to learn about the culture in which they practice.²⁰² For example, for First Nations communities, it has been suggested that developing health education materials that respectfully depict female bodies, sexuality, and health behaviour through a First Nations lens may be appropriate.²⁵⁹ Further, First Nations women have also emphasized the need for more culturally sensitive education addressed to community members of all genders, starting at school.²²¹ Again, these are not unique to HPV screening, but may facilitate the implementation of an HPV screening program.

Creative and Practical Solutions to Systemic Barriers

Overcoming systemic barriers is often more difficult. Each community must assess its own needs and resources to design creative solutions. One solution that has been proposed by the National Aboriginal Health Organization is that a community health centre could arrange for an HCP to visit them in conjunction with nearby communities.⁴⁷³ Additional resources, including more health care staff and more transportation options, could also help address systemic barriers.

HPV Self-Sampling

As mentioned previously, HPV self-sampling has the potential to overcome many systemic barriers, improving access to people in rural and remote communities and to people from socioeconomically disadvantaged groups.^{20,208,221,377,455,459,460} Self-sampling could also overcome cultural barriers because, when conducted at home, it can provide a culturally or religiously safe procedure.^{20,455,459,485,486}