Enlisting patients to self-collect specimens for human papillomavirus testing is an effective way to detect cervical precancer in those who might not otherwise undergo cervical cancer screening. PRACTICE CHANGER: Have patients who decline a pelvic examination self-collect a specimen for human papillomavirus polymerase chain reaction testing as an alternative to a clinician-collected one. STRENGTH OF RECOMMENDATION: Meta-analysis of observational trials

Hoss, Molly

Lyon, Corey

English

University of Missouri: MOspace

306 THE JOURNAL OF FAMILY PRACTICE  |   JULY/AUGUST 2020  |   VOL 69, NO 6Priority Updates from the Research Literature from the Family Physicians Inquiries NetworkPURLs®Molly Hoss, MD;  Corey Lyon, DO University of Colorado Family Medicine Residency, DenverD E P U T Y  E D I T O RShailendra Prasad, MBBS, MPH University of Minnesota North Memorial Family Medicine Residency Program, MinneapolisDo-it-yourself cervical cancer screening? Enlisting patients to self-collect specimens for human papillomavirus testing is an effective way to detect cervical precancer in those who might not otherwise undergo cervical cancer screening. PRACTICE CHANGERHave patients who decline a pelvic examina-tion self-collect a specimen for human papil-lomavirus polymerase chain reaction testing as an alternative to a clinician-collected one.STRENGTH OF RECOMMENDATION B: Meta-analysis of observational trials.1Arbyn M, Smith SB, Temin S, et al; Collaboration on Self-Sampling and HPV Testing. Detecting cervical precancer and reaching under-screened women by using HPV testing on self-samples: updated meta-analyses. BMJ. 2018;363:k4823.ILLUSTRATIVE CASEA 40-year-old woman presents to your office to establish care. During your interview you realize that she has never been screened for cervical cancer. In fact, she has not had a pelvic exam because she is fearful of the procedure. She would like to know if alternatives exist for cervical cancer screening. What can you suggest?Although deaths from cervical cancer decreased in the United States from 1975 to 2017, demographic and so-cial disparities in the burden of the disease remain.2,3 Data from 2016 reveal that cervical cancer incidence per 100,000 women is low-est among white (7.5), Asian-Pacific Islander (5.8), and American Indian/Alaska native (5.6) women, and highest among Hispanic (9.8) and black (8.7) women, which could be explained by lower screening rates in these populations.4,5 The National Cancer Insti-tute’s publication on reducing cancer health disparities states that the most effective way to reduce cervical cancer incidence and mor-tality is by increasing screening rates among women who have not been screened or who have not been screened regularly.6The US Food and Drug Administration (FDA) approved the first human papilloma-virus (HPV) screening test in 2003.7 Evidence now suggests that high-risk HPV screening provides greater protection against cervical cancer than screening with cytology alone.8 The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) have changed their recommendations to include primary HPV testing as an alternative method to Pap smears for cervical cancer screening.9An advantage of primary HPV screen-ing is that it can be performed on a specimen collected by the patient, which could poten-tially increase rates of screening and help to decrease demographic and social disparities. A randomized trial of almost 2000 women ages 21 to 65 years that evaluated the accept-ability of this method to patients revealed that more than half of women prefer the idea of a self-collected specimen to one that is collected by a clinician because it is more convenient and obviates the need for a pelvic exam.10 A meta-analysis of 36 studies and more than 150,000 women concluded that when 307MDEDGE.COM/FAMILYMEDICINE VOL 69, NO 6  |  JULY/AUGUST 2020  |  THE JOURNAL OF FAMILY PRACTICECONTINUEDself-collected samples were used with signal-based assays, the tests were not as sensitive or specific as when clinician-collected samples were used.11 However, the meta-analysis also found that some polymerase chain reaction (PCR)-based HPV tests were similarly sen-sitive for both self- and clinician-collected samples. STUDY SUMMARYPCR vs signal amplification HPV tests with collection by patients vs cliniciansThis meta-analysis compared the accuracy of high-risk HPV self-screening with clinician collection of samples (56 diagnostic accu-racy trials; total N not provided) in identify-ing cervical intraepithelial neoplasia grade 2 or worse (CIN 2+) with signal amplifica-tion and PCR tests evaluated separately.1 In addition, this review evaluated strategies to screen women who are underscreened or not screened, which was defined as women who were irregularly or never screened, or did not respond to reminder letters about cervical cancer screening (25 randomized controlled trials [RCTs]; total N not provided).❚ In the diagnostic accuracy studies, pa-tients collected a vaginal sample themselves and then had a sample taken by a clinician. CIN 2+ or 3+ was confirmed by either colpos-copy and biopsy performed on all patients or by a positive high-risk HPV test result. Studies were further divided into those using assays based on signal amplification or PCR. In signal amplification assays, the pooled sensitivity for CIN 2+ was lower in the group with the self-collected samples than in the clinician-collected sample group (77%; 95% confidence interval [CI], 69%-82% vs 93%; 95% CI, 89%-96%). The pooled specificity to exclude CIN 2+ was also lower in the group with the self-collected samples (84%; 95% CI, 77%-88% vs 86%; 95% CI, 81%-90%). In high-risk HPV assays based on PCR, there was no difference in sensitivity (96%) or specificity (79%) between the specimen groups.With regard to the pooled relative sen-sitivity and specificity of signal amplifica-tion assays, those using self-swab samples were less sensitive and less specific for CIN 2+ (sensitivity ratio = 0.85; 95% CI, 0.80-0.89; specificity ratio =  0.96; 95% CI, 0.93-0.98) and CIN 3+ (sensitivity ratio = 0.86; 95% CI, 0.76-0.98; specificity ratio = 0.97; 95% CI, 0.95-0.99). Using PCR assays, there was no difference between groups in relative sensi-tivity for the diagnosis of CIN 2+ (sensitivity ratio = 0.99; 95% CI, 0.97-1.02) and CIN 3+ (sensitivity ratio = 0.99; 95% CI, 0.96-1.02). Relative specificity was slightly lower in the self-swab group for CIN 2+ (specificity ratio = 0.98; 95% CI, 0.97-0.99) and CIN 3+ (specific-ity ratio = 0.98; 95% CI, 0.97-0.99). ❚ The second analysis to evaluate which outreach strategies are effective methods for screening underscreened/unscreened women found that delivering self-sample kits to patients was more effective than the con-trol method, which was sending reminders to women to undergo conventional screen-ing (95% vs 53%; mean difference [MD], 41%; 95% CI, 3%-78%). Similarly, mailing kits to patients compared favorably to the control method (25% vs 12%; MD, 13%; 95% CI, 10%-15%). WHAT’S NEWSelf-collected specimens can be as reliable as clinician-collected onesThis is the first study to provide robust evi-dence that high-risk HPV PCR-based assays using patient self-collected specimens are as sensitive at diagnosing CIN 2+ or 3+ as using clinician-collected samples. CAVEATSBalancing lower specificity with  reaching underscreened populationsPatients with a positive HPV test result re-quire additional testing. The success rates for this follow-up are not known and could be a barrier to accurate diagnoses because of accessibility and patient willingness to fol-low up with a pelvic exam. In addition, self-collection may be less specific than cytology and could increase colposcopy referrals that lead to negative findings and overtreatment.12 However, the increased acceptance of this screening method could make it an effective strategy to reach underscreened or reluctant patients. This study offers robust evidence that high-risk HPV PCR-based assays using patient-collected specimens are as sensitive at diagnosing CIN 2+ or 3+ as using clinician-collected samples. 308 THE JOURNAL OF FAMILY PRACTICE  |   JULY/AUGUST 2020  |   VOL 69, NO 6PURLs®CHALLENGES TO IMPLEMENTATIONAvailability of PCR-based HPV assays may be an issueHPV PCR assays may not be available at all laboratories, but signal amplification HPV tests have been shown to be inferior to PCR assays. Physicians will have to confirm with their laboratories whether PCR-based HPV assays are available.                JFPACKNOWLEDGEMENTThe PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.Copyright © 2020. The Family Physicians Inquiries Network. All rights reserved. References  1.   Arbyn M, Smith SB, Temin S, et al; Collaboration on Self-Sam-pling and HPV Testing. Detecting cervical precancer and reach-ing underscreened women by using HPV testing on self-samples: updated meta-analyses. BMJ. 2018;363:k4823. 2.   National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer stat facts: cervical cancer. www.seer.cancer.gov/statfacts/html/cervix.html. Accessed June 29, 2020. 3.   Singh GK, Azuine RE, Siahpush M. Global inequalities in cervical cancer incidence and mortality are linked to deprivation, low so-cioeconomic status, and human development. Int J MCH AIDS. 2012;1:17‐30.  4.   US Cancer Statistics Working Group. US Cancer Statistics Data Visualizations Tool, based on November 2018 submission data (1999-2016): US Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute. June 2019. www.cdc.gov/cancer/dataviz. Accessed June 29, 2020. 5.   MacLaughlin KL, Jacobson RM, Breitkopf CR, et al. Trends over time in Pap and Pap-HPV cotesting for cervical cancer screening. J Womens Health. 2019;28:244-249.  6.   Freeman HP, Wingrove BK. Excess Cervical Cancer Mortality: A Marker for Low Access to Health Care in Poor Communities. NIH Pub. No. 05–5282. Rockville, MD: National Cancer Institute, Center to Reduce Cancer Health Disparities, May 2005. www.cancer.gov/about-nci/organization/crchd/about-health-disparities/resources/excess-cervical-cancer-mortality.pdf. Accessed June 29, 2020.  7.   FDA approves expanded use of HPV test. Infection Control Today. March 31, 2003. www.infectioncontroltoday.com/guidelines/fda-approves-expanded-use-hpv-test. Accessed June 29, 2020.  8.   Ronco G, Dillner J, Elfström K, et al. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014;383: 524-532. 9.   CDC. Cervical cancer screening guidelines for average-risk wom-en. www.cdc.gov/cancer/cervical/pdf/guidelines.pdf. Accessed June 29, 2020. 10.   Mao C, Kulasingam S, Whitham H, et al. Clinician and patient acceptability of self-collected human papillomavirus testing for cervical cancer screening. J Womens Health. 2017;26:609-615. 11.   Arbyn M, Verdoodt F, Snijders PJ, et al. Accuracy of human pap-illomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014;15:172-183. 12.   Lazcano-Ponce E, Lorincz A, Cruz-Valdez A, et al. Self-collection of vaginal specimens for human papillomavirus testing in cer-vical cancer prevention (MARCH): a community-based ran-domised controlled trial. Lancet. 2011;378:1868-1873.found on our Web site at www.mdedge.com/familymedicine.  We remain committed to supplying you with all of the information you need to provide your patients with the very best care—no matter what brings them in to see you.                      JFPjfp.eic@gmail.comEDITORIALReferences 1.   Low-cost dexamethasone reduces death by up to one third in hospitalized patients with severe respiratory complications of COVID-19. Recovery: Randomised Evaluation of COVID-19 Therapy Web site. June 16, 2020. www.recoverytrial.net/ news/low-cost-dexamethasone-reduces-death-by-up-to- one-third-in-hospitalised-patients-with-severe-respiratory-complications-of-covid-19. Accessed July 1, 2020. 2.   Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the treatment of Covid-19—preliminary report [published online ahead of print]. N Engl J Med. doi: 10.1056/NEJMoa2007764. 3.   Li L, Zhang W, Hu Y, et. al. Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: a randomized clinical trial [published online ahead of print]. JAMA. doi:10.1001/jama.2020. 10044. 4.   Stokes EK, Zambrano LD, Anderson KN, et al. Coronavirus disease 2019 case surveillance—United States, January 22–May 30, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:759-765. 5.   Xu J, Murphy SL, Kochanek KD, et al. Mortality in the United States, 2018. NCHS Data Brief. 2020;1-8.CONTINUED FROM PAGE 271

Do-it-yourself cervical cancer screening?

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Do-it-yourself cervical cancer screening?

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