A community‐based, cross‐sectional study of hr HPV DNA self‐sampling‐based cervical cancer screening in rural Karnataka, India

May combine two claims.

Studies from India have identified barriers to cervical cancer screening on several socioecological levels, including lack of knowledge, personal disbelief in prevention of cancer, lack of care-seeking when asymptomatic, lack of money for treatment, and reduced access to healthcare services.

“Studies from India have identified barriers on several socioecological levels such as lack of knowledge, personal disbelief in prevention of cancer, lack of care-seeking when asymptomatic, lack of money for treatment, and reduced access to healthcare services [6–8].”

• cites [6] Nene B,, Determinants of women s participation in cervical cancer screening trial, Maharashtra, India. Bulletin of the World Health Organization, 2007 85(4): p. 264– 272. 17546307 PMC2636321 sourcePartly supported

  The Introduction and Discussion identify lack of knowledge, unfamiliarity with prevention, and economic and geographic barriers to cervical cancer screening. The paper does not specifically identify failure to seek care when asymptomatic or lack of money for treatment as barriers; the Discussion says treatment in this study was free and economic barriers were unlikely to explain reduced follow-up. (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites [7] Aswathy S,, Cervical cancer screening: Current knowledge & practice among women in a rural population of Kerala, India. The Indian Journal of Medical Research, 2012 136(2): p. 205– 210. 22960886 PMC3461731Not checked — no full text of the source
• cites [8] Adsul P,, Implementing community-based cervical cancer screening programs using visual inspection with acetic acid in India: A systematic review. Cancer Epidemiol, 2017 49: p. 161– 174. 28704717 PMC5571735 sourcePartly supported

  The Introduction reports low public awareness and few screening facilities in India, while Results > Implementation barriers and facilitators reports reluctance to visit a clinic when asymptomatic. These passages support several listed barriers, but the copy does not identify disbelief in cancer prevention or lack of money for treatment as barriers. (LLM, conf=0.86)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim.

The self-collection option offers the distinct advantage of moving primary screening activities from the clinic into the community.

“The self-collection option also offers the distinct advantage of moving primary screening activities from the clinic into the community [12].”

• cites [12] Gravitt PE,, Looking ahead: a case for HPV testing of self-sampled vaginal specimens as a cervical cancer screening strategy. International journal of cancer. Journal international du cancer, 2011 129(3): p. 517– 527. 21384341 PMC3782104 sourceSupported

May combine two claims.

Cancer was detected in two women, who were referred to appropriate healthcare facilities for further treatment.

“Cancer was detected in two women, who were referred to appropriate healthcare facilities for further treatment.”

May combine two claims.

The majority of participants were aged 30-39 years, had no formal schooling, belonged to a lower caste, and lived in a household with an annual income of approximately US$1499.

“The majority of participants were aged 30–39 years, with no formal schooling, from a lower caste, and lived below an annual household income of US$1499.”

• Also stated in: § RESULTS · plain

  “As shown in Table 1, the majority of the participants were aged 30–39 years, with no formal schooling, belonging to a lower caste (considered as a socioeconomic indicator), and lived in a household that earned an annual household income of approximately US$1499 (₹104,930).”

The quote only partly states this claim.

A total of 473 women aged 30-59 years, not pregnant, and without a history of cancer or hysterectomy underwent self-sampling.

“After group health education and one-on-one counseling, a total of 473 women underwent self-sampling.”

• Also stated in: § RESULTS · plain

  “A total of 473 women aged 30–59 years, not pregnant, and without a history of cancer or hysterectomy were included in the study.”

May combine two claims.

Of the 24 followed-up women, 19 (79.2%) tested negative on cervical smear, three (12.5%) had atypical glandular cells, one had low-grade and one had high-grade lesion.

“A total of 19 women (79.2%) tested negative on cervical smear, three (12.5%) had atypical glandular cells, one had low-grade and one had high-grade lesion reported on the cervical smear tests.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The study staff invested up to 16 additional months in conducting health education sessions and counseling women to complete their follow-up visits.

“The study staff invested up to 16 additional months in conducting health education sessions and counseling women to complete their follow-up visits.”

May combine two claims.

Compliance with follow-up in this study was approximately 66.6%, which was lower compared with a study reporting follow-up rates of 78% when screening was implemented in primary healthcare centers.

“Compliance with follow-up in our study was approximately 66.6%, which was lower compared with a study reporting follow-up rates of 78% when screening was implemented in primary healthcare centers [19].”

• cites [19] Mittal S,, HPV detection-based cervical cancer screening program in low-resource setting: lessons learnt from a community-based demonstration project in India. Cancer Causes & Control, 2016 27(3): p. 351– 358. 26712612 sourceNot checked — no full text of the source

• AssumptionRests on an assumption: The impact of screening on mortality reduction requires high screening coverage and that screen-positive women receive appropriate diagnostic and treatment services.

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

From anecdotal evidence, several women sought second opinions from gynecologists practicing in the private sector, often resulting in a preference for hysterectomies.

“From anecdotal evidence, several of these women sought second opinions from gynecologists practicing in the private sector, often resulting in a preference for hysterectomies.”

Classified as probably not a substantial claim.

A persistent HPV infection causes most cases of cervical cancer.

“A persistent infection with HPV causes most cases of cervical cancer; for many women who have an existing HPV infection or do not have access to HPV vaccination, improved screening for early detection and treatment remains the best option for reducing the cervical cancer burden [2].”

• cites [2] Gravitt PE and Rositch AF, HPV self-testing and cervical cancer screening coverage. The Lancet Oncology, 2014 15(2): p. 128– 129. 24433681 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S2 (checkable).

Substantial resources are required for providing health education and one-on-one counseling to inform asymptomatic women about the benefits of testing and to improve compliance with follow-up.

“However, substantial resources are required for providing health education and one-on-one counseling to inform asymptomatic women about the benefits of testing and, more importantly, to improve compliance with follow-up.”

• AssumptionRests on an assumption: The impact of screening on mortality reduction requires high screening coverage and that screen-positive women receive appropriate diagnostic and treatment services.

May combine two claims.

The Hybrid Capture 2 assay is based on signal amplification techniques and considered less sensitive and specific when used on self-collected samples.

“The Hybrid Capture 2 assay is based on signal amplification techniques and considered less sensitive and specific when used on self-collected samples [10].”

• cites [10] Arbyn M,, Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. The lancet oncology, 2014 15(2): p. 172– 183. 24433684 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

All study materials, including the consent form, were translated into Kannada and pilot tested with a small group of women from the same community before use.

“Before being used in the study, all study materials, including the consent form, were translated into the local language of Kannada and pilot tested with a small group of women from the same community.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

This study is one of the few from India that used self-collection with the Hybrid Capture 2 assay in a community-based rural setting.

“In summary, this study is one of the few from India that used self-collection with the Hybrid Capture 2 assay in a community-based rural setting.”

• AssumptionRests on an assumption: This demonstration study is one of the first attempts at studying the feasibility of conducting a screening program in rural India using hrHPV DNA tests as a primary screening strategy.

Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

Implementation of a molecular test for cervical cancer screening can increase the opportunities for cervical cancer screening in communities where it is needed the most.

“Implementation of a molecular test for cervical cancer screening can increase the opportunities for cervical cancer screening in communities where it is needed the most.”

May combine two claims.

Ensuring follow-up of women who were hrHPV-positive was the most challenging aspect of the study and required considerable resources, including time.

“Ensuring follow-up of women who were hrHPV-positive, however, was the most challenging aspect of the study and required considerable resources, including time.”

May combine two claims.

Overcoming the challenge of women not attending due to pain/discomfort took several additional hours of counseling and resulted in modifications of health education materials and approach.

“Overcoming this challenge took several additional hours of counseling and resulted in modifications of our health education materials and approach.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Involving laboratory personnel in the study team was instrumental in specimen collection and transportation to the lab for testing.

“Involving laboratory personnel in the study team was instrumental in specimen collection and transportation to the lab for testing.”

May combine two claims.

For hrHPV DNA testing, self-collected vaginal samples are an acceptable strategy and have shown comparable sensitivity and specificity to clinician-collected samples.

“For hrHPV DNA testing, self-collected vaginal samples are an acceptable strategy and have shown comparable sensitivity and specificity to clinician-collected samples [10].”

• cites [10] Arbyn M,, Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. The lancet oncology, 2014 15(2): p. 172– 183. 24433684 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

A cross-sectional study design is prone to a non-response bias, in that participants consenting to participate may be different from the ones who do not participate.

“A cross-sectional study design is also prone to a non-response bias, in that participants consenting to participate may be different from the ones who do not participate.”

May combine two claims.

The study estimated a sample size of 368 for a prevalence study with finite population correction at 5% precision, 95% confidence interval, unknown prevalence 50%, population 8400, and with 20% oversampling final sample size 450.

“Using this information, we estimated a sample size for a prevalence study with a finite population correction as follows: at a 5% precision level, 95% confidence interval, an unknown prevalence of HPV infection at 50% for a population of 8 400, the estimated sample size was 368. With 20% oversampling for missing data, we calculated the final sample size to be 450.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Quality control procedures per the manufacturer's instructions for the equipment and kits were followed.

“Quality control procedures per the manufacturer’s instructions for the equipment and the kits were followed.”

May combine two claims.

Women in low-resource settings find pelvic exams to be embarrassing, painful, and uncomfortable and therefore prefer the self-sampling option.

“There is evidence that women in low-resource settings find pelvic exams to be embarrassing, painful, and uncomfortable; therefore, they prefer the self-sampling option [9].”

• cites [9] Dzuba IG,, The acceptability of self-collected samples for HPV testing vs. the pap test as alternatives in cervical cancer screening. J Womens Health Gend Based Med, 2002 11(3): p. 265– 75. 11988136 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Study team members used the teach-back method to check women's understanding.

“Study team members used the teach-back method to check women’s understanding.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Prior training and knowledge of community logistics helped effective functioning of the screening.

“Prior training and knowledge of community logistics helped effective functioning of the screening.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The hrHPV DNA test has been considered a very cost-effective option for low- and middle-income countries and is generally considered feasible if all screen-positive women receive treatment.

“The hrHPV DNA test has been considered a very cost-effective option for low- and middle-income countries and is generally considered feasible if all screen-positive women receive treatment [13].”

• cites [13] Denny L,, Interventions to close the divide for women with breast and cervical cancer between low-income and middle-income countries and high-income countries. The Lancet, 2017 389(10071): p. 861– 870. 27814963 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

Uptake of screening is only the first step in the process.

“Uptake of screening, however, is only the first step in the process.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

This work has limited generalizability and cannot be considered as representative for all of India.

“Furthermore, this work has limited generalizability and cannot be considered as representative for all of India.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The pathology laboratory used the 2001 Bethesda system for reporting results of cervical cytology and followed standard quality control procedures per the National Accreditation Board for Testing and Calibration Laboratories.

“The pathology laboratory used the 2001 Bethesda system for reporting results of cervical cytology and followed standard quality control procedures per the National Accreditation Board for Testing and Calibration Laboratories [18].”

• cites [18] Solomon D,, The 2001 Bethesda System: terminology for reporting results of cervical cytology. Jama, 2002 287(16): p. 2114– 9. 11966386 sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The staff physician and nurses had been trained in performing VIA and cervical smears previously and had been delivering these services in the community for the previous eight years.

“The staff physician and nurses had been trained in performing VIA and cervical smears previously and had been delivering these services in the community for the previous eight years.”

Probably not a substantial claim: may not pass S2 (checkable).

The option of self-sampling may be essential to improving the effectiveness of the program in hard-to-reach populations.

“The option of self-sampling may be essential to improving the effectiveness of the program in hard-to-reach populations [25].”

• cites [25] Lazcano-Ponce E,, Self-collection of vaginal specimens for human papillomavirus testing in cervical cancer prevention (MARCH): A community-based randomised controlled trial. The Lancet, 2011 378(9806): p. 1868– 1873. 22051739 sourceNot checked — no full text of the source