Characteristics of Included Primary Studies

Dr. Yi-Sheng Chao; Michelle Clark; Elizabeth Carson; Dr. Laura Weeks; Kristen Moulton; Dr. Susan McFaul; Dr. C.M McLauchlin; Dr. Bernice Tsoi; Umair Majid; Sujane Kandasamy; Neha Arora; Dr. Meredith Vanstone; Dr. Lynette Reid; Timothy Krahn; Kasia Kaluzny; Kelly Farrah; Caitlyn Ford

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Chao YS, Clark M, Carson E, et al. HPV Testing for Primary Cervical Cancer Screening: A Health Technology Assessment [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Mar. (CADTH Optimal Use Report, No. 7.1b.)

Cover of HPV Testing for Primary Cervical Cancer Screening: A Health Technology Assessment

HPV Testing for Primary Cervical Cancer Screening: A Health Technology Assessment [Internet].

Show details

Contents

< Prev Next >

Appendix 7Characteristics of Included Primary Studies

Table 42Characteristics of Primary Studies Published After Systematic Reviews

First Author, Year Trial Name	Country, Clinical Setting, Study Design	Study Population (n)	Index Test	Comparator Test	Screening Pathway and Interval	Outcomes of Interest
Randomized Controlled Trials
Lamin, 2017⁴²	Sweden Established and routinely running organized, large-scale population-based screening program	Women aged 56 to 60 years invited to their last cervical cancer screening appointment (n = 14,763)	HPV test (Cobas) with cytology triage of HPV-positive patients	Cytology with HPV triage (Cobas) of low-grade cytological abnormalities Abnormal = ASCUS +)	Cytology testing HPV testing with cytology triage Routine screening interval 5 years after age 51	Acceptance of screening Referral to colposcopy
Cook, 2016⁴³ HPV FOCAL trial, subset of the intervention group	Canada Subanalysis of HPV FOCAL trial	Women aged 25 to 65 years randomized after 2010, HC2 positive and LBC negative at baseline and rescreened after 12 months (n = 3,473)	Clinician-collected HPV test (Aptima)	Clinician-collected HPV test (HC2)	Subset of HPV testing in Ogilvie, 2017²⁷	DTA Referral to colposcopy
Enerly, 2016⁴⁴	Norway Norwegian cervical cancer screening program	Women aged 25 to 69 years who did not regularly attend the national cervical cancer screening program (due for a second reminder, at least four years since last screening) (n = 3,393)	Self-collected HPV test (CLART and HC2) at home	Clinician-collected LBC test	Cytology testing No triage or colposcopy specified HPV testing with cytology triage No colposcopy specified Routine screening interval 3 years	Acceptance of screening
Racey, 2016⁴⁵	Canada Cervical cancer screening by family health team in Ontario	Women aged 30 to 70 years who were overdue for cervical cancer screening, at least three years since last screening (n = 818)	Self-collected HPV test at home	Reminder letter for Pap test Standard of care opportunistic screening	Cytology Self-collected HPV Routine screening interval Every 2 to 3 years	Acceptance of screening/ compliance
Sultana, 2016⁴⁶ iPap Trial	Australia Established routine cervical cancer screening program	Women aged 30 to 69 years who were under- or never screened for cervical cancer, not screened in the past five years (n = 16,320)	Self-collected HPV test (Cobas)	Clinician-collected Pap test Abnormal = not mentioned	Cytology HPV self-collected sample HPV 16/18+ with colposcopy Routine screening interval Receive reminders every 27 months after last negative test	Acceptance of screening
Williams, 2016⁴⁷	US Patients recruited from medically underserved and low-income neighbourhoods	Women aged 21 years or greater who lived in identified areas or were previous participants of the screening program and were due for a screening test (n = 120)	Self-collected HPV test with tampons (Cobas)	Clinic administered Pap test, HPV test, and pelvic exam	HPV self-collected sample followed by invite to cytology, clinician-collected HPV test, and pelvic exam Routine screening interval Cytology = 3 years HPV = 5 years	Acceptance of screening/ compliance
Zehbe, 2016⁴⁸	Canada Cervical cancer screening in First Nations communities in Northwest Ontario	Women aged 25 to 69 years living in 11 First Nations communities eligible for cervical cancer screening (randomized by community) (n = 834)	Self-collected HPV test	Clinician-collected Pap test Abnormal not defined	Cytology Per Ontario screening program HPV self-collected sample Cytology triage for high-risk positive sample Routine screening interval 3 years	Acceptance of screening
Cadman, 2015⁴⁹	UK Newcastle upon Tyne	Women aged 25 to 65 years who had failed to attend cervical cancer screening after at least two invitations, at least 46 weeks since initial invitation (n = 6,000)	Self-collected HPV test (HC2)	Physician-collected cytology test Abnormal not defined	Two groups were sent up to two reminders for screening within 46 weeks	Acceptance of screening
Rossi, 2015⁵⁰	Italy Organized screening program	Women aged 30 to 64 years non-responding to screening invitation three months ago (n = 14,041)	Self-collected HPV test (HC2) at home Self-collected HPV test in pharmacy	Pap test at clinic Abnormal = ASCUS+ Physician-collected HPV test (HC2) at clinic	HPV with cytology triage ≥ ASCUS to colposcopy OR HPV+ straight to colposcopy and cytology Routine screening interval Cytology = 3 years HPV = 5 years	Acceptance of screening
Co-testing Studies
Jin, 2016¹⁹	US Primary cervical cancer screening in an integrated health system Retrospective cohort	Women aged 30 years and older undergoing cervical cancer screening with HPV test and cytology co-testing (n = 99,549)	Clinician-collected HPV test (HC2)	Cytology from co-testing Abnormal = ASCUS+	Cytology Negative to routine screening ASCUS to HPV triage with HPV+ with colposcopy ≥ ASC-H to colposcopy HPV with cytology triage Co-testing > ASCUS or = ASCUS and HPV+ to colposcopy Routine screening interval 3 years	DTA
Wright, 2015⁶⁰ ATHENA Study	US Routine cervical cancer screening Prospective cohort study Co-testing study	Women aged 25 years and older attending routine cervical cancer screening with HPV test and cytology co-testing (n = 41,955)	Clinician-collected HPV test (Cobas)	LBC Abnormal = ASCUS+	Co-testing All those with abnormal cytology and HPV+ and a subset of those with negative results went to colposcopy Routine screening interval Not specified Three-year follow-up within the study	DTA
Non-Randomized Studies
Chatzistamatiou, 2017⁵¹ PIPAVIR study	Greece and Germany Routine cervical cancer screening in primary care Prospective cohort study	Women aged 30 to 60 visiting primary care clinics for cervical cancer screening (n = 1,723)	Clinician-collected HPV test (Multiplex Genotyping)	LBC Abnormal = ASCUS+	Co-testing Negative on both tests returns to routine screening HPV+, cytology-positive, or HPV and cytology-positive referred to colposcopy Routine screening interval Not reported	DTA Referral to colposcopy
Granados, 2017⁵²	Spain Opportunistic screening program	Women aged 25 to 65 visiting primary care physicians for cervical cancer screening (n = 5,063)	HPV co-testing (Aptima and Pap test)	Analysis of Pap results only Abnormal = ASCUS+	Co-testing ASCUS+ reviewed by cytotechnologist Cytology HSIL directly with colposcopy HPV+ offered colposcopy Routine screening interval not specified	Acceptance of screening Referral to colposcopy
Kocsis, 2017⁵³ TRACE trial	Hungary Outpatient clinic-based cervical cancer screening Prospective multi-centre cohort study	Women aged 18 to 65 years presenting for cervical cancer screening (n = 6,761)	HPV test (CONFIDENCE assay)	HPV test (Cobas and Full Spectrum HPV test) LBC Abnormal = ASCUS+	Cross-sectional co-testing	DTA
Altobelli, 2016⁵⁴	Italy Comparing organized and spontaneous cervical cancer screening	Women aged 25 to 64 years undergoing cervical cancer screening after invitation or attending spontaneously (n = 38,348)	HPV test (HC2)	Conventional cytology Abnormal = ASCUS	Cytology Negative returns to routine screening HPV test with cytology triage Cytology-positive on triage to colposcopy Routine screening interval = 3 years	Acceptance of screening
Ilangovan, 2016⁵⁵	US “Safety net clinics” for uninsured and low-income patients	Haitian and Latina women aged 30 to 65 years with no Pap smear in the past 3 years (n = 180)	Self-collected HPV test (Aptima and Cervista Invader)	Clinician-collected Pap test Abnormal not specified	HPV+ were referred to clinicians for further follow-up Routine screening interval not specified	Acceptance of screening
Agorastos, 2015⁵⁶ HERMES Study	Greece Established cervical cancer screening program Ongoing prospective observational study	Women aged 25 to 55 years attending routine cervical cancer screening with co-testing (n = 4,009)	HPV test (Cobas)	LBC Abnormal = ASCUS+	Co-testing Negative on both tests returns to usual screening Positive on cytology and/or HPV to colposcopy Routine screening interval = 3 years	DTA
Chiappetta, 2015⁵⁷	Italy Assessment of a new cervical cancer screening program	Women aged 25 to 64 due for routine cervical cancer screening (n = 25,210)	HPV test (HC2) with LBC triage women aged 35 to 64 HPV-positive = ≥ 1 RLU	Cytology test Only women aged 25 to 34	Cytology Negative to routine screening ASCUS to HPV triage LSIL+ to colposcopy HPV test Negative to routine screening Positive to cytology triage Routine screening interval = 3 years	Acceptance of screening Referral to colposcopy
Iftner, 2015⁵⁸	Germany Established cervical cancer screening program Prospective observational study	Women aged 30 to 60 years undergoing routine cervical cancer screening with co-testing (n = 10,040)	HPV test (Aptima and HC2)	LBC Abnormal = ASCUS+	Co-testing All negative tests return to routine screening Some participants from the single and double positive groups went to colposcopy Routine screening interval not specified	DTA
Pasquale, 2015⁵⁹	Italy Established screening program switching from Pap testing to HPV testing for cervical cancer screening	Women aged 25 to 64 years eligible for a new round of cervical cancer screening within an established screening program (n = 18,728)	Co-testing (HC2 and cytology) HC2 positive = ≥ 1 RLU	Midwife-collected cytology test Abnormal = ASCUS+	HPV and cytology-positive to colposcopy Routine screening interval = 3 years	Acceptance of screening

: + = or more advanced pathological findings; ASC-H = atypical squamous cells – cannot exclude HSIL; ASCUS = atypical squamous cells of undetermined significance; DTA = diagnostic test accuracy; HC2 = Hybrid Capture 2; FOCAL = FOr CervicAL cancer; HSIL = high-grade squamous intraepithelial lesion; LBC = liquid-based cytology; LSIL = low-grade squamous intraepithelial lesion; Pap = Papanicolaou test; PIPAVIR = Detection of persistent infections by human papillomaviruses; RLU = relative light unit; SR = systematic review; TRACE = Triage and Risk Assessment of Cervical Precancer by Epigenetic Biomarker; VIA = visual inspection with acetic acid.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK543104

Contents

< Prev Next >

PubReader
Print View
Cite this Page
Chao YS, Clark M, Carson E, et al. HPV Testing for Primary Cervical Cancer Screening: A Health Technology Assessment [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Mar. (CADTH Optimal Use Report, No. 7.1b.) Appendix 7, Characteristics of Included Primary Studies.
PDF version of this title (8.2M)

Other titles in this collection

CADTH Optimal Use Reports

Recent Activity

Clear Turn Off Turn On

Characteristics of Included Primary Studies - HPV Testing for Primary Cervical C...
Characteristics of Included Primary Studies - HPV Testing for Primary Cervical Cancer Screening: A Health Technology Assessment

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

Bookshelf

HPV Testing for Primary Cervical Cancer Screening: A Health Technology Assessment [Internet].

Appendix 7Characteristics of Included Primary Studies

Table 42Characteristics of Primary Studies Published After Systematic Reviews

Views

Other titles in this collection

Recent Activity