Showing papers by "Mona Saraiya published in 2020"
TL;DR: The global scale-up of HPV vaccination and HPV-based screening—including self-sampling—has potential to make cervical cancer a rare disease in the decades to come, and could help shape and monitor the initiative to eliminate cervical cancer as a major public health problem.
1,867 citations
Boston University1, University of Pittsburgh2, Yeshiva University3, Virginia Commonwealth University4, Rutgers University5, University of Alabama at Birmingham6, Harvard University7, University of California, Los Angeles8, Northwestern University9, Centers for Disease Control and Prevention10, University of California, San Francisco11, National Institutes of Health12
TL;DR: The 2019 ASCCP Risk-Based Management Consensus Guidelines Committee concluded that the current consensus on risk-based management guidelines is inadequate and called for further work on this issue.
Abstract: This is the fourth American Society of Colposcopy and Cervical Pathology (ASCCP)-sponsored consensus guidelines for management of cervical cancer screening abnormalities, after the original consensus conferences in 20011 and subsequent updates in 20062 and 2012.3 An interim guidance publication providing management recommendations for primary HPV screening was released in 2015.4 This document updates and replaces all previous guidance. The key difference between 2019 guidelines and previous versions is the change from primarily test results–based algorithms (e.g., “Colposcopy is recommended for patients with HPV-positive atypical squamous cells of undetermined significance [ASC-US], low-grade squamous intraepithelial lesion [LSIL],” etc.) to primarily “risk-based” guidelines (e.g., “Colposcopy is recommended for any combination of history and current test results yielding a 4.0% or greater probability of finding CIN 3+,” etc.). See Box 1 for essential changes. Tables of risk estimates for possible combinations of current screening test results and screening history (including unknown history) have been generated from a prospective longitudinal cohort of more than 1.5 million patients followed for more than a decade at Kaiser Permanente Northern California (KPNC). All KPNC estimates of risk underlying guideline decisions are detailed in the accompanying article by Egemen et al.5 The applicability of these risk estimates to other United States regions and populations has been confirmed in other data sets from screening programs and clinical trials.6 Many patients, especially those with minor abnormalities, can be managed by identifying their risk level using Tables 1A to 5B in Egemen et al5 and linking it to a recommended clinical action (return to routine screening, surveillance with repeat testing at 1- or 3-year intervals, colposcopy, or treatment). To facilitate use of these tables, the same information will be accessible via smartphone app (for purchase) and web (no cost) through http://www.asccp.org. Decision aids may facilitate use of the tables.7 Common abnormalities are managed using risk estimates outlined in Section E, and rare abnormalities are managed via the result-specific consensus recommendations outlined in Sections G-K.
Box 1. Essential Changes From Prior Management Guidelines
1) Recommendations are based on risk, not results.
Recommendations of colposcopy, treatment, or surveillance will be based on a patient's risk of CIN 3+ determined by a combination of current results and history (including unknown history). The same current test results may yield different management recommendations depending on the history of recent past test results.
2) Colposcopy can be deferred for certain patients.
Repeat HPV testing or cotesting at 1 year is recommended for patients with minor screening abnormalities indicating HPV infection with low risk of underlying CIN 3+ (e.g., low-grade cytologic abnormalities after a documented negative screening HPV test or cotest).
At the 1-year follow-up test, referral to colposcopy is recommended if results remain abnormal.
3) Guidance for expedited treatment is expanded (i.e., treatment without colposcopic biopsy).
Expedited treatment was an option for patients with HSIL cytology in the 2012 guidelines; this guidance is now better defined.
For nonpregnant patients 25 years or older, expedited treatment, defined as treatment without preceding colposcopic biopsy demonstrating CIN 2+, is preferred when the immediate risk of CIN 3+ is ≥60%, and is acceptable for those with risks between 25% and 60%. Expedited treatment is preferred for nonpregnant patients 25 years or older with high-grade squamous intraepithelial lesion (HSIL) cytology and concurrent positive testing for HPV genotype 16 (HPV 16) (i.e., HPV 16–positive HSIL cytology) and never or rarely screened patients with HPV-positive HSIL regardless of HPV genotype.
Shared decision-making should be used when considering expedited treatment, especially for patients with concerns about the potential impact of treatment on pregnancy outcomes.
4) Excisional treatment is preferred to ablative treatment for histologic HSIL (CIN 2 or CIN 3) in the United States. Excision is recommended for adenocarcinoma in situ (AIS).
5) Observation is preferred to treatment for CIN 1.
Treatment remains acceptable for patients with repeat diagnoses of CIN 1 persisting 2 years or more.
6) Histopathology reports based on Lower Anogenital Squamous Terminology (LAST)/World Health Organization (WHO) recommendations for reporting histologic HSIL should include CIN 2 or CIN 3 qualifiers, i.e., HSIL(CIN 2) and HSIL (CIN 3).
7) All positive HPV tests, regardless of genotype, should have additional reflex triage testing performed from the same laboratory specimen (e.g., reflex cytology).
Additional testing from the same laboratory specimen is recommended because the findings may inform colposcopy practice. For example, those with HSIL cytology and concurrent positive testing for HPV genotype 16 qualify for expedited treatment.
HPV 16 or 18 infections have the highest risk for CIN 3 and occult cancer, so additional evaluation (e.g., colposcopy with biopsy) is necessary even when cytology results are negative.
If HPV 16 and 18 testing is positive, and additional laboratory testing of the same sample is not feasible, the patient should proceed directly to colposcopy.
8) Continued surveillance with HPV testing or cotesting at 3-year intervals for at least 25 years is recommended after treatment of histologic HSIL, CIN 2, CIN 3, or AIS. Continued surveillance at 3-year intervals beyond 25 years is acceptable for as long as the patient's life expectancy and ability to be screened are not significantly compromised by serious health issues.
The 2012 guidelines recommended return to 5-year screening intervals and did not specify when screening should cease. New evidence indicates that risk remains elevated for at least 25 years, with no evidence that treated patients ever return to risk levels compatible with 5-year intervals.
Surveillance with cytology alone is acceptable only if testing with HPV or cotesting is not feasible. Cytology is less sensitive than HPV testing for detection of precancer and is therefore recommended more often. Cytology is recommended at 6-month intervals when HPV testing or cotesting is recommended annually. Cytology is recommended annually when 3-year intervals are recommended for HPV or cotesting.
9) Human papilloma virus assays that are Food and Drug Administration (FDA)-approved for screening should be used for management according to their regulatory approval in the United States. (Note: all HPV testing in this document refers to testing for high-risk HPV types only).
For all management indications, HPV mRNA and HPV DNA tests without FDA approval for primary screening alone should only be used as a cotest with cytology, unless sufficient, exceptionally rigorous data are available to support primary HPV testing in management.
The minimum amount of data required to generate a recommendation will include the patient's age and current test results, as we recognize that previous screening history is often not known. Increased precision of management guidance will be possible if information is available on test results within the past 5 years and previous precancer treatment within the past 25 years.3 Current results and past history are designed to generate the patient's risk estimate from data tables.5 Risk estimates are available for the following clinical situations: abnormal screening test results with unknown history, abnormal screening test results with medical record documentation of a preceding negative HPV test or cotest, surveillance of previous abnormal screening test results that did not require immediate colposcopic referral (e.g., follow-up after an HPV-positive cytology negative result), colposcopy/biopsy results, and follow-up surveillance tests after colposcopy or after treatment for, or resolution of, high-grade abnormalities (e.g., CIN 2+).
The recognition that persistent HPV infection is necessary for developing precancer and cancer (defined as CIN 3+, which includes diagnoses of CIN 3, AIS, and cancer) underlies the 2019 guideline update. Prospective longitudinal data indicate that when a new abnormal screening test result follows a negative HPV test or cotest within the past 5 years, the estimated risk of CIN 3+ is reduced by approximately 50%.8 A negative cytology result within 3 years of a new abnormal screening test, however, does not confer a similar reduction in risk.9 The 2019 guidelines also recognize that a colposcopic examination performed according to accepted standards (e.g., using the KPNC colposcopy protocol or the ASCCP Colposcopy Standards10) confirming low-grade or normal histology reduces a patient's estimated risk of having precancer/cancer in the next 2 years.11 This allows patients with an HPV-positive ASC-US or LSIL result at their 1-year follow-up visit after a colposcopy confirming normal- or low-grade histology to return for repeat HPV or cotesting in 1 more year, rather than immediately return to colposcopy. Thus, incorporating a patient's history of previous HPV tests and colposcopy/biopsy results will permit detection and treatment of CIN 3+ while avoiding unnecessary interventions for patients with new HPV infections who are at lower risk.12
528 citations
TL;DR: Most factors associated with not receiving HPV vaccine were similar across all three MSAs, including living in the South, having a mother with some college education, not having an 11–12-year-old well-child visit, and not receiving a provider recommendation for vaccination.
Abstract: The 2016 and 2017 National Immunization Surveys-Teen (NIS-Teen) highlighted disparities in human papillomavirus (HPV) vaccination coverage by metropolitan statistical area (MSA) status. Coverage wi...
36 citations
TL;DR: This analysis found that more than half of BPEs and almost three-quarters of Pap tests performed among young women aged 15 to 20 years during the years 2011 through 2017 were potentially unnecessary, exposing women to preventable harms.
Abstract: Importance Pelvic examination is no longer recommended for asymptomatic, nonpregnant women and may cause harms such as false-positive test results, overdiagnosis, anxiety, and unnecessary costs. The bimanual pelvic examination (BPE) is an invasive and controversial examination component. Cervical cancer screening is not recommended for women younger than 21 years. Objectives To estimate prevalence of potentially unnecessary BPE and Papanicolaou (Pap) tests performed among adolescent girls and women younger than 21 years (hereinafter referred to as young women) in the United States and to identify factors associated with receiving these examinations. Design, Setting, and Participants A cross-sectional analysis of the National Survey of Family Growth from September 2011 through September 2017 focused on a population-based sample of young women aged 15 to 20 years (n = 3410). The analysis used survey weights to estimate prevalence and the number of people represented in the US population. Data were analyzed from December 21, 2018, through September 3, 2019. Main Outcomes and Measures Receipt of a BPE or a Pap test in the last 12 months and the proportion of potentially unnecessary examinations and tests. Results Responses from 3410 young women aged 15 to 20 years were included in the analysis with 6-year sampling weights applied. Among US young women aged 15 to 20 years represented during the 2011-2017 study period, 4.8% (95% CI, 3.9%-5.9%) were pregnant, 22.3% (95% CI, 20.1%-24.6%) had undergone STI testing, and 4.5% (95% CI, 3.6%-5.5%) received treatment or medication for an STI in the past 12 months (Table 1). Only 2.0% (95% CI, 1.4%-2.9%) reported using an IUD, and 33.5% (95% CI, 30.8%-36.4%) used at least 1 other type of hormonal contraception in the past 12 months. Among US young women aged 15 to 20 years who were surveyed in the years 2011 through 2017, approximately 2.6 million (22.9%; 95% CI, 20.7%-25.3%) reported having received a BPE in the last 12 months. Approximately half of these examinations (54.4%; 95% CI, 48.8%-59.9%) were potentially unnecessary, representing an estimated 1.4 million individuals. Receipt of a BPE was associated with having a Pap test (adjusted prevalence ratio [aPR], 7.12; 95% CI, 5.56-9.12), testing for sexually transmitted infections (aPR, 1.60; 95% CI, 1.34-1.90), and using hormonal contraception other than an intrauterine device (aPR, 1.31; 95% CI, 1.11-1.54). In addition, an estimated 2.2 million young women (19.2%; 95% CI, 17.2%-21.4%) reported having received a Pap test in the past 12 months, and 71.9% (95% CI, 66.0%-77.1%) of these tests were potentially unnecessary. Conclusions and Relevance This analysis found that more than half of BPEs and almost three-quarters of Pap tests performed among young women aged 15 to 20 years during the years 2011 through 2017 were potentially unnecessary, exposing women to preventable harms. The results suggest that compliance with the current professional guidelines regarding the appropriate use of these examinations and tests may be lacking.
20 citations
TL;DR: To assess the likely effectiveness of expanded COVID-19 infection prevention and control procedures and determine SARS-CoV-2 infection prevalence among patients and health care personnel at the state hospital, a point prevalence survey was conducted.
Abstract: In the United States, approximately 180,000 patients receive mental health services each day at approximately 4,000 inpatient and residential psychiatric facilities (1). SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), can spread rapidly within congregate residential settings (2-4), including psychiatric facilities. On April 13, 2020, two patients were transferred to Wyoming's state psychiatric hospital from a private psychiatric hospital that had confirmed COVID-19 cases among its residents and staff members (5). Although both patients were asymptomatic at the time of transfer and one had a negative test result for SARS-CoV-2 at the originating facility, they were both isolated and received testing upon arrival at the state facility. On April 16, 2020, the test results indicated that both patients had SARS-CoV-2 infection. In response, the state hospital implemented expanded COVID-19 infection prevention and control (IPC) procedures (e.g., enhanced screening, testing, and management of new patient admissions) and adapted some standard IPC measures to facilitate implementation within the psychiatric patient population (e.g., use of modified face coverings). To assess the likely effectiveness of these procedures and determine SARS-CoV-2 infection prevalence among patients and health care personnel (HCP) (6) at the state hospital, a point prevalence survey was conducted. On May 1, 2020, 18 days after the patients' arrival, 46 (61%) of 76 patients and 171 (61%) of 282 HCP had nasopharyngeal swabs collected and tested for SARS-CoV-2 RNA by reverse transcription-polymerase chain reaction. All patients and HCP who received testing had negative test results, suggesting that the hospital's expanded IPC strategies might have been effective in preventing the introduction and spread of SARS-CoV-2 infection within the facility. In congregate residential settings, prompt identification of COVID-19 cases and application of strong IPC procedures are critical to ensuring the protection of other patients and staff members. Although standard guidance exists for other congregate facilities (7) and for HCP in general (8), modifications and nonstandard solutions might be needed to account for the specific needs of psychiatric facilities, their patients, and staff members.
18 citations
TL;DR: Mid-adult vaccination is much less cost-effective than the comparison strategy of routine vaccination for all adolescents at ages 11 to 12 years and catch-up vaccination for women through age 26 years and men through age 21 years.
12 citations
TL;DR: Stakeholder feedback was incorporated into the development of the 2019 ASCCP Risk-Based Management Consensus Guidelines, and findings underscore the importance of stakeholder feedback in developing guidelines that meet the needs of patients and providers.
Abstract: Objective The 2019 ASCCP Risk-Based Management Consensus Guidelines present a paradigm shift from results- to risk-based management. Patient and provider factors can affect guideline adoption. We sought feedback from stakeholders to inform guideline development. Materials and methods To solicit provider feedback, we surveyed attendees at the 2019 ASCCP annual meeting regarding readiness to adopt proposed changes and used a web-based public comment period to gauge agreement/disagreement with preliminary guidelines. We elicited patient feedback via a brief survey on preferences around proposed recommendations for treatment without biopsy. Surveys and public comment included both closed-ended and free-text items. Quantitative results were analyzed using descriptive statistics; qualitative results were analyzed using content analysis. Results were incorporated into guideline development in real time. Results Surveys indicated that 98% of providers currently evaluate their patients' past results to determine management; 88% felt formally incorporating history into management would represent an improvement in care. Most providers supported expedited treatment without biopsy: 22% currently perform expedited treatment and 60% were willing to do so. Among patients, 41% preferred expedited treatment, 32% preferred biopsy before treatment, and the remainder were undecided. Responses from the public comment period included agreement/disagreement with preliminary guidelines, reasons for disagreement, and suggestions for improvement. Conclusions Stakeholder feedback was incorporated into the development of the 2019 ASCCP Risk-Based Management Consensus Guidelines. Proposed recommendations with less than two-thirds agreement in the public comment period were considered for revision. Findings underscore the importance of stakeholder feedback in developing guidelines that meet the needs of patients and providers.
10 citations
01 Jun 2020
TL;DR: Infidencebased mortality rates were higher among individuals in USAPI jurisdictions than among Asian/ Pacific Islanders in Hawai'i for many cancers preventable through vaccination, smoking cessation, overweight and obesity prevention, and cancer screening.
Abstract: Cancer-related mortality in the US-Affiliated Pacific Island (USAPI) jurisdictions is unknown This is the first ever reporting of cancer-related mortality in the USAPI using cancer registry data The individual USAPI jurisdictions collected incident cancer data and submitted it to the Pacific Regional Central Cancer Registry (PRCCR) All cases reported to PRCCR (n = 3,118) with vital status of dead (n = 1,323) during 2008-2013 were examined Cause of death was coded based on clinical information provided in the cancer registry Incidencebased mortality (IBM) rates were calculated using SEER*Stat software and age adjusted to the US standard population Total cancer IBM rates among males were highest in Palau (1515 per 100,000), Republic of the Marshall Islands (RMI, 1420), and Guam (1332); rates were lowest in American Samoa (217), the Commonwealth of the Northern Mariana Islands (CNMI, 227), and the Federated States of Micronesia (FSM, 289) Total cancer IBM rates among females were highest in RMI (1203 per 100,000), Palau (1077), and Guam (722); rates were lowest in CNMI (190), FSM (232), and American Samoa (428) The median time from cancer diagnosis to death was 8-28 days in the Freely Associated States and 102-128 days in the Flag Territories IBM rates were higher among individuals in USAPI jurisdictions than among Asian/ Pacific Islanders in Hawai'i for many cancers preventable through vaccination, smoking cessation, overweight and obesity prevention, and cancer screening Geographic remoteness, underreporting, delay in reporting, and challenges with accurate death registration and certification led to lower IBM rates for some jurisdictions These mortality data can help prioritize evidence-based interventions to reduce cancer-related deaths through risk factor reduction, early detection, and improved quality of life after a cancer diagnosis through palliative care
6 citations
TL;DR: India's cervical cancer screening was launched in 2016 and baseline facility readiness using nationally representative data from the 2012-13 District Level Household and Facility Survey was low, with Goa and Maharashtra consistently top 5 ranking states for readiness.
2 citations
01 Jun 2020
TL;DR: The challenges of collecting data from dispersed populations spread across multiple islands of the US-Affiliated Pacific Islands are likely leading factors driving the magnitude of the registries' cost per case.
Abstract: Background: The costs of cancer registration have previously been estimated for registries in the continental United States and many international registries; however, to date, there has been no economic assessment of population-based registries in the US-Affiliated Pacific Islands This study estimates the costs and factors affecting the operations of US-Affiliated Pacific Island population-based cancer registries Methods: The web-based International Registry Costing Tool1 was used to collect costs, resources used, cancer cases processed, and other registry characteristics from the Pacific Regional Central Cancer Registry (PRCCR), Federated States of Micronesia National Cancer Registry, and nine satellite jurisdictional registries within the US Pacific Islands The registries provided data on costs for June 30, 2016-June 29, 2017, and cases processed during 2014 Results: Local host institutions provided a vital source of support for US-Affiliated Pacific Islands registries, covering substantial fixed costs, such as management and overhead The cost per cancer case processed had an almost tenfold variation across registries, with the average total cost per case of about $1,413 The average cost per inhabitant in the US-Affiliated Pacific Islands was about $177 per person Discussion: The challenges of collecting data from dispersed populations spread across multiple islands of the US-Affiliated Pacific Islands are likely leading factors driving the magnitude of the registries' cost per case The economic information from this study provides a valuable source of activity-based cost data that can both help guide cancer control initiatives and help registries improve operations and efficiency