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Recommendations and good practice statements on screening and treatment to prevent cervical cancer for both the general population and women living with HIV. The WHO recommends using HPV DNA detection as the primary screening test instead of VIA or cytology. The document also discusses the benefits and limitations of different primary screening tests, follow-up after negative triage tests or treatments, and the use of molecular HPV testing.
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Acknowledgements v Acronyms and abbreviations vii Executive summary viii Background viii Methods viii Summary of screening and treatment recommendations to prevent cervical cancer x
1. Introduction 1 1.1 Background 1 1.2 Approaches to screening and treatment 3 1.3 Rationale for this new edition of recommendations 4 1.4 Phased approach for the development of the recommendations 5 1.5 Target audience 6 2. Methods 7 2.1 Groups contributing to the guideline development process 7 2.2 Scoping review and appraisal of the existing recommendations 9 2.3 Priority questions for review of evidence 10 2.4 Priority algorithms 11 2.5 Outcomes 11 2.6 Syntheses of evidence 12 2.7 Development of the recommendations 18 2.8 Management of the external peer review 19 3. Important considerations for the recommendations 20 3.1 Programme considerations 20 3.2 Screening and triage tests considered in this guideline 21 3.3 Treatment considerations 23
Contents iii
4. Recommendations and good practice statements on screening and 24 treatment to prevent cervical cancer 4.1 Recommendations and good practice statements: 24 general population of women 4.2 Recommendations and good practice statements: women living with HIV 31 4.3 Additional recommendation and good practice statement 38 for treatment not covered in previous guidelines for the general population of women and women living with HIV **5. Research gaps and further considerations 39
Web annex A: Syntheses of the evidence
Available at: https://www.who.int/publications/i/item/ (Includes IARC handbook materials and Supplementary materials 1–13)
Web annex B: Evidence-to-decision (EtD) tables
Available at: https://www.who.int/publications/i/item/ (Includes EtD for PICO questions 1–10)
Contents iv
James Killen, Gigi Lui, Diep Nguyen, Bernardo Nuche, Catherine Sauvaget, Holger Schünemann, Kate Simms, Ronaldo Silva, Karin Sundström, Katayoun Thaghavi, Cari van Schalkwyk and Brian Williams.
The following individuals acted as observers at the GDG meeting: Benjamin Anderson, J. (Hans) Berkhof, Smiljka de Lussigny, Eduardo Franco, Lisa Pei-Ching Huang, Krishna Jafa, Jose Jeronimo, Somesh Kumar, Ilana Lapidos-Salaiz, David Mesher, Jasantha Odayar, Groesbeck Parham, Carmen Pérez Casas, Felipe Roitberg and Heather Watts.
The WHO Secretariat included Maribel Almonte Pacheco, Prebo Barango, Partha Basu, Paul Bloem, Nathalie Broutet, Gary Clifford, Marilys Corbex, Myriam Cortes, Shona Dalal, Jean-Marie Dangou, Maeve De Mello, Gampo Dorji, Linda Eckert, Fayad El Sheikh, Elena Fidarova, Massimo Ghidinelli, Karima Gholbzouri, Rodolfo Gomez Ponce de Leon, Sami Gottlieb, Joumana George Hermez, Raymond Hutubessy, Andre Ilbawi, Naoko Ishikawa, Chandani Anoma Jayathilaka, Rajat Khosla, Warrick Junsuk Kim, Stephanie Yetunde Kuku, Hugues Lago, Beatrice Lauby-Secretan, Silvana Luciani, Priya Mannava, Dara Masoud, Manjulaa Narasimhan, Morkor Newman, Leopold Ouedraogo, Tina Purnat, Neena Raina, Ajay Rangaraj, Leanne Margaret Riley, Anita Sands, Tshidi Sebitloane, Mukta Sharma, Hai-rim Shin, Slim Slama, Vitaly Smelov, Howard Sobel, Ute Ströher, Adriana Velazquez Berumen, Lara Vojnov and Hongyi Xu.
Funding for the preparation, development and printing of the guideline was provided mainly by the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), with the support of the United States President’s Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID), and Unitaid.
This guideline was edited and proofread by Green Ink.
Acknowledgements vi
AIS adenocarcinoma in situ
ART antiretroviral therapy
CIN cervical intraepithelial neoplasia
CKC cold knife conization
DOI declaration of interest
ERG External Review Group
EtD evidence-to-decision
GDG Guideline Development Group
GRC Guidelines Review Committee
GRADE Grading of Recommendations Assessment, Development and Evaluation
HPV human papillomavirus
HRP UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research,
Development and Research Training in Human Reproduction
IARC International Agency for Research on Cancer
IPD-MA individual patient data meta-analysis
LEEP loop electrosurgical excision procedure (also known as LLETZ)
LLETZ large-loop excision of the transformation zone (also known as LEEP)
NAAT nucleic acid amplification test
PEPFAR The United States President’s Emergency Plan for AIDS Relief
PICO population (P), intervention (I), comparator (C), outcome (O)
SDG Sustainable Development Goal
UNAIDS Joint United Nations Programme on HIV/AIDS
UNDP United Nations Development Programme
UNFPA United Nations Population Fund
UNICEF United Nations Children’s Fund
USAID United States Agency for International Development
VIA visual inspection with acetic acid
WHO World Health Organization
Acronyms and abbreviations vii
The Guideline Development Group (GDG) for this guideline was formed in early 2019, and the GDG, WHO Secretariat, methodologists and technical groups (see Annex 1 ) met several times to establish the PICO questions, methodology and timeline. The WHO Secretariat led and coordinated the whole process to ensure recommendations were developed in line with the WHO handbook for guideline development, second edition (2014). The methods for evidence synthesis and mathematical modelling were used as applied in the previous edition of the guideline, WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention. Based on clinical expertise, research and knowledge of tests in development, the Guideline Development Group (GDG) initially identified the screening tests and clinical algorithms for screening and treatment that could be evaluated. The GDG prioritized seven algorithms for evaluation, and these informed the systematic reviews. In 2020, the systematic review teams performed the systematic reviews for each of the PICO questions and, in parallel, the systematic reviews that had been prepared for the International Agency for Research on Cancer’s IARC handbooks of cancer prevention: cervical cancer screening, Vol. 18 (2021) were integrated for the development of these recommendations.
When relevant evidence was not available in primary research, a mathematical model was used to estimate the risk of important outcomes (e.g. recurrence of high-grade cervical intraepithelial neoplasia [CIN], cervical cancer) associated with the use of different screening and treatment strategies. In addition, a modelling group was created to evaluate the impact and cost–effectiveness of the different screening and treatment algorithms. Furthermore, we searched the published literature for studies providing information on acceptability, feasibility and costing aspects of these algorithms, and conducted a survey on feasibility and values and preferences of people using these services. GDG meetings took place on a weekly basis between August 2020 and November 2020 to review and assess the evidence and agree on the final new and updated recommendations and good practice statements presented in this guideline.
Executive Summary ix
In this present publication, there is a total of 23 recommendations and 7 good practice statements.
In Table 1 below we have grouped the recommendations and good practice statements in two columns for the general population of women (left column, nos. 1–14) and for women living with HIV (right column, nos. 21–34), while in Table 2, the populations are not separated (nos. 41 and 42).^1
There are currently 11 recommendations and 3 good practice statements for each population in Table 1, and an additional recommendation and good practice statement for both populations in Table 2.
(^1) There are gaps in these numbers because WHO intends to issue additional recommendations soon on screening tests and implemen- tation, which will be numbered as needed (expected to be 15–20 for the general population of women and 35–40 for women living with HIV).
Executive Summary x
Recommendations for the general population ofwomen
a
Strength ofrecommendationand level ofevidence
Recommendations for women living with HIV
a
Strength ofrecommendationand level ofevidence
3a.
In a screen-and-treat approach
using HPV
DNA detection as the primary screening test, WHOsuggests treating women who test positive for HPVDNA among the general population of women.3b.
In a screen, triage and treat approach
using
HPV DNA detection as the primary screening testamong the general population of women, WHOsuggests using partial genotyping, colposcopy, VIA orcytology to triage women after a positive HPV DNAtest (
Annex 4
Remarks: The benefits, harms and programmatic costsof the triage options are similar; therefore, the choiceof triage method will be dependent on feasibility,training, programme quality assurance and resourcesin countries. HPV16/18 genotyping could be integratedinto the HPV DNA test (refer to Annex 4 for specificdetails of the algorithms).
Conditionalrecommendation,moderate-certainty evidence
In a screen, triage and treat approach
using
HPV DNA detection as the primary screening testamong women living with HIV, WHO suggests usingpartial genotyping, colposcopy, VIA or cytology totriage women after a positive HPV DNA test (
Annex 4
Remarks: The benefits, harms and programmatic costsof the triage options are similar; therefore, the choiceof triage method will be dependent on feasibility,training, programme quality assurance and resourcesin countries. HPV16/18 genotyping could be integratedinto the HPV DNA test (refer to Annex 4 for specificdetails of the algorithms).
Conditionalrecommendation,moderate-certainty evidence
Conditionalrecommendation,low-certaintyevidence
Conditionalrecommendation,low-certaintyevidence
age of 30 years
among the general
population of women.
Strongrecommendation,moderate-certainty evidence
age of 25 years
among women living
with HIV. Remarks: Low-certainty evidence found that there arelikely to be small numbers of women living with HIVwith cervical cancer who are below the age of 25. Thisrecommendation applies to women living with HIVregardless of when they first tested positive for HIV.
Conditionalrecommendation,low-certaintyevidence
xii
Executive Summary
Recommendations for the general population ofwomen
a
Strength ofrecommendationand level ofevidence
Recommendations for women living with HIV
a
Strength ofrecommendationand level ofevidence
Conditionalrecommendation,low-certaintyevidence
Conditionalrecommendation,very low-certaintyevidence
aged
30–49 years
in the general population of women.
When tools are available to manage women aged50–65 years, those in that age bracket who have neverbeen screened should also be prioritized.
Good practicestatement
aged 25–49 years
. When tools are available
to manage women living with HIV aged 50–65 years,those in that age bracket who have never beenscreened should also be prioritized.
Good practicestatement
every
5 to 10 years
when using HPV DNA detection as the
primary screening test among the general populationof women.
Conditionalrecommendation,low-certaintyevidence
when using HPV DNA detection
as the primary screening test among women livingwith HIV.
Conditionalrecommendation,low-certaintyevidence
Conditionalrecommendation,low-certaintyevidence
Conditionalrecommendation,low-certaintyevidence
xiii
Executive Summary
a^ Rows shaded in blue indicate that the recommendation or good practice statement is identical for both the general population of women (left column) and women living with HIV (right column). In other rows, thewording of the recommendations differs for each population.
xv
Executive Summary
Recommendations for the general population ofwomen
a
Strength ofrecommendationand level ofevidence
Recommendations for women living with HIV
a
Strength ofrecommendationand level ofevidence
Good practicestatement
Good practicestatement
For both the general population and women living with HIV HPV: human papillomavirus; VIA: visual inspection with acetic acid.a Rows shaded in blue indicate that the recommendation or good practice statement is identical for both the general population of women (left column) and women living with HIV (right column). In other rows, thewording of the recommendations differs for each population.
Strength of recommendation andcertainty of evidence
Good practice statement
Conditional recommendation,low-certainty evidence
Table 2. Recommendation and good practice statement for treatment not covered in previous guidelines
Executive Summary xvi
The traditional method to screen women for cervical cancer has been cytology (the Papanicolaou test, also known as the Pap smear or smear test). When cytology results are positive, the diagnosis is confirmed by colposcopy, and appropriate treatment is informed by biopsy of suspicious lesions for histological diagnosis. In countries with effective cytology-based cervical cancer screening and treatment programmes, the mortality from cervical cancer has been reduced fivefold over the past 50 years (6). This screening approach has not been as successful in low- and middle-income countries (7).
Newer screening tests introduced in the last 15 years include visual inspection with acetic acid (VIA), and molecular tests, mainly high-risk HPV DNA-based tests, 3 which are suitable for use in all settings ( Table 1.1 ). More recently, even newer tests and techniques have been developed: (i) other molecular tests such as those based on HPV mRNA, oncoprotein detection or DNA methylation; (ii) more objective tests performed on cytological samples such as p16/Ki-67 dual staining; and (iii) more advanced visual inspection tests based on artificial intelligence/machine learning platforms (e.g. automated visual evaluation of digital images) (8–11).
Introduction 2
Molecular Cytologic Visual inspection
Nucleic acid amplification tests (NAAT) a » high-risk HPV DNA/ NAAT » mRNA
DNA methylation b
Protein biomarkers b » HPV antibodies » oncoproteins
Conventional Pap smeara
Liquid-based cytology (LBC) a
Dual staining to identify p and Ki-67a
Visual inspection with acetic acid or with Lugol’s iodine (VIA/VILI) a » naked eye » magnified by colposcope or camera
Automated visual evaluation of digital images b
Table 1.1 Three approaches to cervical cancer screening and future tests
a (^) Current tests b (^) Tests under evaluation (future tests).
(^3) In this guideline, “an HPV DNA test” refers to a high-risk HPV DNA test. An HPV DNA test is a nucleic acid amplification test (NAAT).
Introduction 3
In a screen-and-treat approach , treatment is provided based on a positive primary screening test alone, without triage (i.e. no second screening test and no histopathological diagnosis).
In a screen, triage and treat approach , the triage test is done if the primary screening test is positive, and the decision to treat is made when both the primary test and the triage test are positive.
(^4) In this guideline, the term LLETZ is used to refer to excision of the transformation zone. In some countries, this terminology was changed to LEEP (loop electrosurgical excision procedure), and the two terms are often used interchangeably.
In this document, two approaches to screening and treatment are distinguished: the screen-and-treat approach and the screen, triage and treat approach.