scholarly journals De-implementation and Substitution of Clinical Care Processes: Stakeholder Perspectives on the Transition to Primary Human Papillomavirus (HPV) Testing for Cervical Cancer Screening

Author(s):  
Erin E Hahn ◽  
Corrine Munoz-Plaza ◽  
Danielle Altman ◽  
Chunyi Hsu ◽  
Nancy Cannizzaro ◽  
...  

Abstract Background: New cervical cancer screening guidelines recommend primary human papillomavirus (HPV) testing for women age 30-65 years. Healthcare organizations are preparing to de-implement the previous recommended strategies of Pap testing or co-testing (Pap plus HPV test) and substitute primary HPV testing. However, there may be significant challenges to replacement of this entrenched clinical practice, even with an evidence-based substitution. We sought to identify stakeholder-perceived barriers and facilitators to this substitution within a large healthcare system, Kaiser Permanente Southern California.Methods: We conducted semi-structured qualitative interviews with clinician, administrative and patient stakeholders regarding: (a) acceptability and feasibility of the planned substitution; (b) perceptions of barriers and facilitators, with an emphasis on those related to the de-implementation/implementation cycle of substitution; and (c) perceived readiness to change. Our interview guide was informed by the Consolidated Framework for Implementation Research (CFIR). Using a team coding approach, we developed an initial coding structure refined during iterative analysis; the data were subsequently organized thematically into domains, key themes, and sub-themes using thematic analysis, followed by framework analysis informed by CFIR.Results: We conducted 23 interviews: 5 patient and 18 clinical/administrative. Clinicians perceived that patients feel more tests equals better care, and clinicians and patients expressed fear of missed cancers (“…it’ll be more challenging convincing the patient that only one test is…good enough to detect cancer.”). Patients perceived practice changes resulting in “less care” are driven by desire to cut costs. In contrast, clinicians/administrators viewed changing from two tests to one as acceptable and a workflow efficiency (“…It’s very easy and half the work.”). Stakeholder-recommended strategies included focusing on the increased efficacy of primary HPV testing and developing clinician talking points incorporating national guidelines to assuage ‘cost-cutting’ fears. Conclusions: Substitution to replace an entrenched clinical practice is complex. Leveraging available facilitators is key to ease the process for clinical and administrative stakeholders—e.g., emphasizing the efficiency of going from two tests to one. Identifying and addressing clinician and patient fears regarding cost-cutting and perceived poorer quality of care is critical for substitution. Multicomponent and multilevel strategies for engagement and education will be required.Trial registration: ClinicalTrials.gov #NCT04371887

2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Erin E. Hahn ◽  
Corrine Munoz-Plaza ◽  
Danielle E. Altman ◽  
Chunyi Hsu ◽  
Nancy T. Cannizzaro ◽  
...  

Abstract Background New cervical cancer screening guidelines recommend primary human papillomavirus (HPV) testing for women age 30–65 years. Healthcare organizations are preparing to de-implement the previous recommended strategies of Pap testing or co-testing (Pap plus HPV test) and substitute primary HPV testing. However, there may be significant challenges to the replacement of this entrenched clinical practice, even with an evidence-based substitution. We sought to identify stakeholder-perceived barriers and facilitators to this substitution within a large healthcare system, Kaiser Permanente Southern California. Methods We conducted semi-structured qualitative interviews with clinician, administrative, and patient stakeholders regarding (a) acceptability and feasibility of the planned substitution; (b) perceptions of barriers and facilitators, with an emphasis on those related to the de-implementation/implementation cycle of substitution; and (c) perceived readiness to change. Our interview guide was informed by the Consolidated Framework for Implementation Research (CFIR). Using a team coding approach, we developed an initial coding structure refined during iterative analysis; the data were subsequently organized thematically into domains, key themes, and sub-themes using thematic analysis, followed by framework analysis informed by CFIR. Results We conducted 23 interviews: 5 patient and 18 clinical/administrative. Clinicians perceived that patients feel more tests equals better care, and clinicians and patients expressed fear of missed cancers (“…it’ll be more challenging convincing the patient that only one test is…good enough to detect cancer.”). Patients perceived practice changes resulting in “less care” are driven by the desire to cut costs. In contrast, clinicians/administrators viewed changing from two tests to one as acceptable and a workflow efficiency (“…It’s very easy and half the work.”). Stakeholder-recommended strategies included focusing on the increased efficacy of primary HPV testing and developing clinician talking points incorporating national guidelines to assuage “cost-cutting” fears. Conclusions Substitution to replace an entrenched clinical practice is complex. Leveraging available facilitators is key to ease the process for clinical and administrative stakeholders—e.g., emphasizing the efficiency of going from two tests to one. Identifying and addressing clinician and patient fears regarding cost-cutting and perceived poorer quality of care is critical for substitution. Multicomponent and multilevel strategies for engagement and education will be required. Trial registration ClinicalTrials.gov, #NCT04371887


2019 ◽  
Vol 64 (1-2) ◽  
pp. 63-70
Author(s):  
Andrea D. Olivas ◽  
Julieta E. Barroeta ◽  
Ricardo R. Lastra

The association between high-risk genotypes of human papillomavirus (hr-HPV) and cervical cancer is well established. As hr-HPV testing is rapidly becoming a part of routine cervical cancer screening, either in conjunction with cytology or as primary testing, the management of hr-HPV-positive women has to be tailored in a way that increases the detection of cervical abnormalities while decreasing unnecessary colposcopic biopsies or other invasive procedures. In this review, we discuss the overall utility and strategies of hr-HPV testing, as well as the advantages and limitations of potential triage strategies for hr-HPV-positive women, including HPV genotyping, p16/Ki-67 dual staining, and methylation assays.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Lisa P. Spees ◽  
Andrea C. Des Marais ◽  
Stephanie B. Wheeler ◽  
Michael G. Hudgens ◽  
Sarah Doughty ◽  
...  

Abstract Background Screening substantially reduces cervical cancer incidence and mortality. More than half of invasive cervical cancers are attributable to infrequent screening or not screening at all. The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening. Methods/design The study will enroll at least 510 US women aged 25–64 years who report no Pap test in the last 4 years and no HPV test in the last 6 years. We will randomize participants to an intervention or control arm. The intervention arm will receive kits to self-collect a sample at home and mail it for HPV testing. In both the intervention and control arms, participants will receive assistance in scheduling an appointment for screening in clinic. Study staff will deliver HPV self-collection results by phone and assist in scheduling participants for screening in clinic. The primary outcome is completion of cervical cancer screening. Specifically, completion of screening will be defined as screening in clinic or receipt of negative HPV self-collection results. Women with HPV-negative self-collection results will be considered screening-complete. All other participants will be considered screening-complete if they obtain co-testing or Pap test screening at a study-affiliated institution or other clinic. We will assess whether the self-collection intervention influences participants’ perceived risk of cervical cancer and whether perceived risk mediates the relationship between HPV self-collection results and subsequent screening in clinic. We also will estimate the incremental cost per woman screened of offering at-home HPV self-collection kits with scheduling assistance as compared to offering scheduling assistance alone. Discussion If mailed self-collection of samples for HPV testing is an effective strategy for increasing cervical cancer screening among women overdue for screening, this method has the potential to reduce cervical cancer incidence and mortality in medically underserved women at higher risk of developing cervical cancer. Trial registration ClinicalTrials.gov NCT02651883, Registered on 11 January 2016.


2011 ◽  
Vol 07 (04) ◽  
pp. 243
Author(s):  
Channa E Schmeink ◽  
Leon FAG Massuger ◽  
Willem JG Melchers ◽  
Ruud LM Bekkers ◽  
◽  
...  

Primary screening based on detection of human papillomavirus (HPV) has proved to be more sensitive than cytology for the detection of high-grade cervical intraepithelial neoplasia (CIN). Self-sampling for specimen collection may also improve the participation rate, especially in the non-responder group. However, HPV is highly prevalent and therefore HPV detection has a lower specificity in cervical cancer screening than cytology. In addition to the clinically validated HPV test, HPV dynamics should be taken into account. It is important to identify women with a chronic productive infection likely to cause, or to already have caused, high-grade CIN or cervical carcinoma, and to limit overtreatment of women with a transient infection. Furthermore, the introduction of the HPV vaccine is likely to lower the incidence of CIN and cervical carcinoma, which will lower the positive predictive value of cervical cancer screening. This potential impact needs to be taken into account when planning for future screening guidelines.


2020 ◽  
Vol 30 (11) ◽  
pp. 1678-1683
Author(s):  
Berit Andersen ◽  
Sisse Helle Njor ◽  
Anne Marie Schak Jensen ◽  
Tonje Johansen ◽  
Ulla Jeppesen ◽  
...  

IntroductionEvidence supports high-risk human papilloma virus (HPV) testing as the primary cervical cancer screening tool. However, benefits and harms should be carefully considered before replacing liquid-based cytology. In women age 50 and older, we evaluated how a commercially available DNA amplification HPV test compares with routine liquid-based cytology.MethodsThis prospective study included 4043 patients who had a cervical sample analyzed from September 2011 to September 2012. Patients were followed between 64 and 76 months (median: 70 months). Samples were analyzed using both liquid-based cytology and the Cobas 4800 HPV DNA test. We calculated the diagnostic efficacy of liquid-based cytology and HPV, with or without the opposite test as triage, using cervical intraepithelial neoplasia (CIN2+/CIN3+) as reference.ResultsThe patients had a median age of 58 years, (range; 50–90). At baseline, HPV prevalence was 8.0%: a total of 3.7% of patients had atypical squamous cells of undetermined significance or worse (ASCUS+). Positive test results were 1.9% for liquid-based cytology with HPV triage and 3.0% for HPV with liquid-based cytology triage. The cumulative incidence of CIN3+ was 1.0% (40/4043). Sensitivities for CIN3+ were: liquid-based cytology 47.5% (31.5%–63.9%); liquid-based cytology with HPV triage 45.0% (29.3%–61.5%); HPV 90.0% (76.3%–97.2%); and HPV with liquid-based cytology triage 67.5% (50.9%–81.4%). Corresponding specificities were: liquid-based cytology 96.6% (96.0%–97.2%); liquid-based cytology with HPV triage 98.5% (98.0%–98.8%); HPV 92.8% (92.0%–93.6%); and HPV with liquid-based cytology triage 97.7% (97.2%–98.1%). At baseline, HPV testing overlooked five cases of gynecological cancer other than cervical cancer. Five cervical cancers were detected, two had been overlooked at baseline by liquid-based cytology and two by HPV testingConclusionHPV screening using DNA amplification is a promising alternative to liquid-based cytology in women age 50 and older, but evaluation of alternative triage methods is warranted. The risk of overlooking cancers needs consideration when replacing liquid-based cytology with HPV testing as a method for primary screening.


2019 ◽  
Vol 63 (5) ◽  
pp. 385-390 ◽  
Author(s):  
Mariko Hashiguchi ◽  
Yoshifumi Nakao ◽  
Atsuko Honda ◽  
Atsushi Kawaguchi ◽  
Katsuyuki Hanashima ◽  
...  

Background: Uterine cervical cancer is the fourth most common female cancer in the world. In Japan, we have an apparently low rate of joining cervical cancer screening programs compared with Western countries. Furthermore, the incidence and mortality rate of cervical cancer among the younger generation has been increasing. Object: The aim of this study was to assess the effectiveness of cervical cancer screening with human papillomavirus (HPV) testing and cytology in Japan. Methods: Collaborating with Saga City government, we initiated a cervical cancer screening system consisting of HPV testing and baseline cervical cytology from April 2011 as a social experiment. A total of 17,284 participants have been screened with this new combination system. Results: After HPV testing with cytology-based cervical cancer screening, the number of screenings done in women aged under 40 years has significantly increased. In addition, the number of women diagnosed with cervical intraepithelial neoplasia grade 3 has increased (25 of 14,025 vs. 146 of 23,049 under 50 years: p < 0.001). Conclusion: These data suggested that the introduction of HPV testing with cytology-based cervical cancer screening as an adjunct to conventional cytology resulted in better efficiency and more accurate screening among the Japanese population.


2019 ◽  
Vol 29 (4) ◽  
pp. 669-675
Author(s):  
Irenjeet Bains ◽  
Yoon Hong Choi ◽  
Kate Soldan ◽  
Mark Jit

ObjectivesIn England, human papillomavirus (HPV) testing is to replace cytological screening by 2019–2020. We conducted a model-based economic evaluation to project the long-term clinical impact and cost-effectiveness of routine cytology versus HPV testing.MethodsAn individual-based model of HPV acquisition, natural history, and cervical cancer screening was used to compare cytological screening and HPV testing with cytology triage for women aged 25–64 years (with either 3- or 5-year screening intervals for women aged under 50 years). The model was fitted to data from England's National Health Service Cervical Screening Programme. Both clinical and economic outcomes were projected to inform cost-effectiveness analyses.ResultsHPV testing is likely to decrease annual cytology testing (by 2.76 million), cervical cancer incidence (by 290 cases), and health system costs (by £13 million). It may increase the number of colposcopies, although this could be reduced without leading to more cancers compared with primary cytology by increasing the interval between screens to 5 years. The impact in terms of quality-adjusted life-years (QALYs) depends on the quality of life weight given to colposcopies versus cancer.ConclusionsEngland's move from cytology to HPV screening may potentially be life-saving and cost-effective. Cost-effectiveness can be improved further by extending the interval between screens or using alternative triage methods such as partial or full genotyping.


2015 ◽  
Vol 24 (9) ◽  
pp. 1304-1310 ◽  
Author(s):  
Mark Schiffman ◽  
Sean Boyle ◽  
Tina Raine-Bennett ◽  
Hormuzd A. Katki ◽  
Julia C. Gage ◽  
...  

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
G. Hoste ◽  
K. Vossaert ◽  
W. A. J. Poppe

Traditional population-based cervical screening programs, based on cytology, have successfully reduced the burden of cervical cancer. Nevertheless limitations remain and new screening methods are emerging. Despite vaccination against the 2 most oncogenic types (HPV 16/18), cervical cancer screening will have to continue as an essential public health strategy. As the acquisition of an HR-HPV infection is critical in the progression to (pre-)cancerous cervical lesions, recent research has focused on HR-HPV detection. The sensitivity of HPV testing in primary and secondary prevention outweighs that of cytology, at the cost of slightly lower specificity. Although most of the HR-HPV infections are cleared after conization, new evidence from numerous studies encourages the implementation of HR-HPV testing and genotyping to improve posttreatment surveillance. An HR-HPV test 6 months after conization is a promising useful clinical marker to detect persistence and prevent progression. This review highlights the clinical role of HPV testing in primary and secondary cervical cancer screening.


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