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Item A National Quality Improvement Study Identifying and Addressing Cancer Screening Deficits Due To the COVID-19 Pandemic(Wiley, 2022) Joung, Rachel Hae-Soo; Nelson, Heidi; Mullett, Timothy W.; Kurtzman, Scott H.; Shafir, Sarah; Harris, James B.; Yao, Katharine A.; Brajcich, Brian C.; Bilimoria, Karl Y.; Cance, William G.; Surgery, School of MedicineBackground: Cancer-related deaths over the next decade are expected to increase due to cancer screening deficits associated with the coronavirus disease 2019 (COVID-19) pandemic. Although national deficits have been quantified, a structured response to identifying and addressing local deficits has not been widely available. The objectives of this report are to share preliminary data on monthly screening deficits in breast, colorectal, lung, and cervical cancers across diverse settings and to provide online materials from a national quality improvement (QI) study to help other institutions to address local screening deficits. Methods: This prospective, national QI study on Return-to-Screening enrolled 748 accredited cancer programs in the United States from April through June 2021. Local prepandemic and pandemic monthly screening test volumes (MTVs) were used to calculate the relative percent change in MTV to describe the monthly screening gap. Results: The majority of facilities reported monthly screening deficits (colorectal cancer, 80.6% [n = 104/129]; cervical cancer, 69.0% [n = 20/29]; breast cancer, 55.3% [n = 241/436]; lung cancer, 44.6% [n = 98/220]). Overall, the median relative percent change in MTV ranged from -17.7% for colorectal cancer (interquartile range [IQR], -33.6% to -2.8%), -6.8% for cervical cancer (IQR, -29.4% to 1.7%), -1.6% for breast cancer (IQR, -9.6% to 7.0%), and 1.2% for lung cancer (IQR, -16.9% to 19.0%). Geographic differences were not observed. There were statistically significant differences in the percent change in MTV between institution types for colorectal cancer screening (P = .02). Conclusion: Cancer screening is still in need of urgent attention, and the screening resources made available online may help facilities to close critical gaps and address screenings missed in 2020. Lay summary: Question: How can the effects of the coronavirus disease 2019 pandemic on cancer screening be mitigated? Findings: When national resources were provided, including methods to calculate local screening deficits, 748 cancer programs promptly enrolled in a national Return-to-Screening study, and the majority identified local screening deficits, most notably in colorectal cancer. Using these results, 814 quality improvement projects were initiated with the potential to add 70,000 screening tests in 2021. Meaning: Cancer screening is still in need of urgent attention, and the online resources that we provide may help to close critical screening deficits.Item Analytical and Clinical Sample Performance Characteristics of the Onclarity Assay for the Detection of Human Papillomavirus(American Society for Microbiology, 2020-12-17) Young, Stephen; Vaughan, Laurence; Yanson, Karen; Eckert, Karen; Li, Aojun; Harris, James; Ermel, Aaron; Williams, James A.; Al-Ghoul, Mohammad; Cammarata, Catherine L.; Taylor, Stephanie N.; Luff, Ronald; Cooper, Charles K.; Van Der Pol, Barbara; Medicine, School of MedicineThe objective of this study was to determine the result reproducibility and performance of the BD Onclarity human papillomavirus (HPV) assay (Onclarity) on the BD Viper LT platform using both contrived and clinical specimens. Reproducibility was assessed in BD SurePath liquid-based cytology (LBC) medium (SurePath) using contrived panels (HPV genotype 16 [HPV16] positive, HPV18 positive, or HPV45 positive) or clinical specimens (HPV16, -18, -31, -33/58, -45, or -52 positive or HPV negative). In addition, specimens from 3,879 individuals from the Onclarity trial were aliquoted prior to or following cytology processing and tested for HPV. Finally, specimens were collected using either the Cervex-Brush or Cytobrush (or Cytobrush/spatula) for comparison of HPV results. Contrived specimens showed >95% concordance with the expected results, and pooled clinical specimens had standard deviations and coefficients of variation ranging from 0.87 to 1.86 and 2.9% to 5.6%, respectively. For precytology and postcytology aliquot analyses, specimens showed >98.0% overall agreement and mean differences in cycle threshold (CT ) scores for HPV ranging from -0.07 to 0.31. Positivity rates were close between the Cervex-Brush and Cytobrush/spatula for all age groups tested. Onclarity results are reproducible and reliable, regardless of sample collection before or after cytology aliquoting. Onclarity performs well regardless of the method of specimen collection (Cervex-Brush or Cytobrush/spatula) for cervical cancer screening.Item A community-based approach to cervical cancer prevention in western Kenya: An AMPATH feasibility project(Sage, 2022-05-23) Orang’o, Omenge; Tonui, Philip; Muthoka, Kapten; Kiptoo, Stephen; Maina, Titus; Agosa, Mercy; Ermel, Aaron; Tong, Yan; Brown, Darron; Medicine, School of MedicineObjectives: Centralized programs have been ineffective in reducing the burden of cervical cancer among Kenyan women. A community-based pilot study was initiated to screen Kenyan women for cervical cancer and to vaccinate their children against human papillomavirus (HPV). Methods: Women were educated about cervical cancer prevention at community meetings. Women then provided self-collected vaginal swabs for oncogenic HPV testing using the Roche Cobas Assay. All women were then referred to the local clinic for Visual Inspection with Acetic Acid (VIA). Women were offered the quadrivalent HPV vaccine for their children if and when it became available for the study. Results: Women in western Kenya were invited to participate in community meetings. A total of 200 women were enrolled: 151 (75.5%) were HIV-uninfected and 49 (24.5%) were HIV-infected; the median age for all women was 42 years. High-risk (HR)-HPV types were detected in 49 of swabs from all 200 participants (24.5%) including 20.5% of HIV-uninfected women and 36.7% of HIV-infected women (P = .022). VIA was performed on 198 women: 192 had normal examinations and six had abnormal examinations. Five cervical biopsies revealed two cases of CIN 2 and one CIN 3. Although all mothers were willing to have their children (N = 432) vaccinated, the HPV vaccine could not be delivered to Kenya during the study period. Conclusions: Kenyan women were willing to attend community meetings to learn about prevention of cervical cancer, to provide self-collected vaginal swabs for HPV testing, to travel to the Webuye Clinic for VIA following the collection of swabs, and to have their children vaccinated against HPV. HR-HPV was prevalent, especially in HIV-infected women. As a result of this pilot study, this community-based strategy to prevent cervical cancer will be continued in western Kenya.Item Development and validation of the cervical cancer knowledge scale and HPV testing knowledge scale in a sample of Canadian women(Elsevier, 2022-12) Haward, Ben; Tatar, Ovidiu; Zhu, Patricia; Griffin-Mathieu, Gabrielle; Perez, Samara; Shapiro, Gilla K.; McBride, Emily; Zimet, Gregory D.; Rosberger, Zeev; Pediatrics, School of MedicineKnowledge of cervical cancer and HPV testing are important factors in proactive and continued engagement with screening and are critical considerations as countries move towards the implementation of HPV-based primary screening programs. However, existing scales measuring knowledge of both cervical cancer and HPV testing are not up to date with the current literature, lack advanced psychometric testing, or have suboptimal psychometric properties. Updated, validated scales are needed to ensure accurate measurement of these factors. Therefore, the aim of this study was to develop and validate two scales measuring cervical cancer knowledge and HPV testing knowledge. A pool of items was generated by retaining relevant existing items identified in a 2019 literature search and developing new items according to themes identified in recent systematic reviews. Items were assessed for relevance by the research team and then refined through seven cognitive interviews with Canadian women. A web-based survey including the remaining items (fourteen for each scale development) was administered to a sample of Canadian women in October and November of 2021. After data cleaning, N = 1027 responses were retained. Exploratory and Confirmatory Factor Analysis were conducted, and Item Response Theory was used to select items. The final cervical cancer knowledge scale (CCKS) and HPV testing knowledge scale (HTKS) were unidimensional, and each consisted of eight items. CFA demonstrated adequate model fit for both scales. The developed scales will be important tools to identify knowledge gaps and inform communications about cervical cancer screening, particularly in the context of HPV-based screening implementation.Item Ensuring a Successful Transition From Cytology to Human Papillomavirus-Based Primary Cervical Cancer Screening in Canada by Investigating the Psychosocial Correlates of Women's Intentions: Protocol for an Observational Study(JMIR, 2022-06-16) Griffin-Mathieu, Gabrielle; Haward, Ben; Tatar, Ovidiu; Zhu, Patricia; Perez, Samara; Shapiro, Gilla K.; McBride, Emily; Thompson, Erika L.; Smith, Laurie W.; Lofters, Aisha K.; Daley, Ellen M.; Guichon, Juliet R.; Waller, Jo; Steben, Marc; Decker, Kathleen M.; Mayrand, Marie-Helene; Brotherton, Julia M. L.; Ogilvie, Gina S.; Zimet, Gregory D.; Norris, Teresa; Rosberger, Zeev; Pediatrics, School of MedicineBackground: The human papillomavirus (HPV) test has emerged as a significant improvement over cytology for primary cervical cancer screening. In Canada, provinces and territories are moving toward implementing HPV testing in cervical cancer screening programs. Although an abundance of research exists on the benefits of HPV-based screening, there is a dearth of research examining women's understanding of HPV testing. In other countries, failure to adequately address women's concerns about changes has disrupted the implementation of HPV-based screening. Objective: The aims of the multipart study described in this paper are to develop psychometrically valid measures of cervical cancer screening-related knowledge, attitudes, and beliefs; to examine the feasibility of a questionnaire examining psychosocial factors related to HPV-based screening; and to investigate psychosocial correlates of women's intentions to participate in HPV-based screening. Methods: We conducted a web-based survey (study 1) of Canadian women to assess the acceptability and feasibility of a questionnaire, including the validation of scales examining cervical cancer knowledge, HPV testing knowledge, HPV testing attitudes and beliefs, and HPV test self-sampling attitudes and beliefs. Preferences for cervical cancer screening were assessed using the best-worst scaling methodology. A second web-based survey (study 2) will be administered to a national sample of Canadian women between June 2022 and July 2022 using the validated scales. Differences in the knowledge, attitudes, beliefs, and preferences of women who are currently either underscreened or adequately screened for cervical cancer will be examined through bivariate analyses. Multinomial logistic regression will be used to estimate the associations between psychosocial and sociodemographic factors and intentions to undergo HPV-based screening. Results: Between October 2021 and November 2021, a total of 1230 participants completed the questionnaire in study 1, and 1027 (83.49%) responses were retained after data cleaning methods were applied. Feasibility was comparable with similar population-based surveys in terms of survey length, participant attrition, and the number of participants excluded after data cleaning. As of May 2022, analysis of study 1 is ongoing, and results are expected to be published in the summer of 2022. Data collection is expected to begin for study 2 in the summer of 2022. Results are expected to be published between late 2022 and early 2023. Conclusions: Findings will provide direction for Canadian public health authorities to align guidelines to address women's concerns and optimize the acceptability and uptake of HPV-based primary screening. Validated scales can be used by other researchers to improve and standardize the measurement of psychosocial factors affecting HPV test acceptability. Study results will be disseminated through peer-reviewed journal articles; conference presentations; and direct communication with researchers, clinicians, policy makers, media, and specialty organizations.Item Persistent Disparities in Cervical Cancer Screening Uptake: Knowledge and Sociodemographic Determinants of Papanicolaou and Human Papillomavirus Testing Among Women in the United States(Sage, 2020) Johnson, Nicole L.; Head, Katharine J.; Foxworthy Scott, Susanna; Zimet, Gregory D.; Communication Studies, School of Liberal ArtsObjectives: Cervical cancer is the second-most common type of cancer among women aged 15-44, and racial, ethnic, and economic disparities exist in survival rates despite widely available screening tests and early treatment options. The objective of this study was to describe the association among knowledge, sociodemographic characteristics, and cervical cancer screening, with the goal of developing interventions to prevent cervical cancer in populations at risk of the disease. Methods: In 2017, we conducted a nationwide survey of women in the United States aged ≥18 who had ever received a Papanicolaou (Pap) test (N = 630). We conducted t tests and one-way analysis of variance to determine sociodemographic differences (age, education, race, ethnicity, income, type of health insurance) in knowledge about cervical cancer screening (Pap test and human papillomavirus [HPV] test). We used logistic regressions to define significant determinants of cervical cancer screening behaviors in the previous 5 years. Results: Of 629 respondents, 407 (64.7%) had an annual household income <$30 000, and 322 of 536 (60.1%) respondents had government-provided health insurance. Of 630 women who had ever had a Pap test, 425 (67.5%) had an HPV test. Hispanic and non-Hispanic white women were more likely than Hispanic and non-Hispanic black women (odds ratio [OR] = 2.49; 95% CI, 1.12-4.54; P = .02) and women with government-provided health insurance (OR = 1.91; 95% CI, 1.08-3.37; P = .03) were more likely than women with private health insurance to have received a Pap test in the previous 5 years. Knowledge of HPV was a significant predictor of having received an HPV test in the previous 5 years (OR = 1.37; 95% CI, 1.22-1.54; P < .001). Conclusion: Disparities in cervical cancer screening among sociodemographic groups of women suggest the need for targeted interventions to improve knowledge about Pap and HPV tests.Item Who Should Decide? Decision-Making Preferences for Primary HPV Testing for Cervical Cancer Screening Among U.S. Women(American Academy of Health Behavior, 2021) Thompson, Erika L.; Garg, Ashvita; Head, Katharine J.; Griner, Stacey B.; Galvin, Annalynn M.; Barnett, Tracey E.; Communication Studies, School of Liberal ArtsRevised U.S. guidelines for cervical cancer screening provide the option of primary human papillomavirus (HPV) testing, Pap testing, or co-testing. Primary HPV testing has not yet been an option for American women, and women may be reluctant to change screening methods. The purpose of this study was to assess correlates of women’s preferences for primary HPV testing decision-making (self, provider, or shared) for cervical cancer screening. Women, aged 30-65, completed an online survey in June of 2018 (n = 812). The outcome variable was preference for decision-making for an HPV test instead of a Pap test on a scale of, healthcare provider, me, or shared. Predictor variables included testing attitudes, social norms, information seeking, previous screening, and socio-demographics. Women who disagreed that people important to them think that they should get the HPV test instead of a Pap test, who were not willing to receive an HPV test instead of a Pap test, and who did not receive HPV vaccinations were less likely to include a provider in their decision-making. In contrast, women who were not up-to-date with their cervical cancer screenings, who had some college or technical level education, or who were over 50 years of age were more likely to prefer to have a healthcare provider included in their decision-making process. While some variation was discovered, women mostly preferred a shared decision or personal decision for HPV testing. Resources to facilitate the decision-making process about this new option for cervical cancer screening are needed.