Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses
Open accessAbstract
Objective: To evaluate the diagnostic accuracy of high-risk human papillomavirus (hrHPV) assays on self samples and the efficacy of self sampling strategies to reach underscreened women. Design: Updated meta-analysis. Data sources: Medline (PubMed), Embase, and CENTRAL from 1 January 2013 to 15 April 2018 (accuracy review), and 1 January 2014 to 15 April 2018 (participation review). Review methods: Accuracy review: hrHPV assay on a vaginal self sample and a clinician sample; and verification of the presence of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) by colposcopy and biopsy in all enrolled women or in women with positive tests. Participation review: study population included women who were irregularly or never screened; women in the self sampling arm (intervention arm) were invited to collect a self sample for hrHPV testing; women in the control arm were invited or reminded to undergo a screening test on a clinician sample; participation in both arms was documented; and a population minimum of 400 women. Results: 56 accuracy studies and 25 participation trials were included. hrHPV assays based on polymerase chain reaction were as sensitive on self samples as on clinician samples to detect CIN2+ or CIN3+ (pooled ratio 0.99, 95% confidence interval 0.97 to 1.02). However, hrHPV assays based on signal amplification were less sensitive on self samples (pooled ratio 0.85, 95% confidence interval 0.80 to 0.89). The specificity to exclude CIN2+ was 2% or 4% lower on self samples than on clinician samples, for hrHPV assays based on polymerase chain reaction or signal amplification, respectively. Mailing self sample kits to the woman’s home address generated higher response rates to have a sample taken by a clinician than invitation or reminder letters (pooled relative participation in intention-to-treat-analysis of 2.33, 95% confidence interval 1.86 to 2.91). Opt-in strategies where women had to request a self sampling kit were generally not more effective than invitation letters (relative participation of 1.22, 95% confidence interval 0.93 to 1.61). Direct offer of self sampling devices to women in communities that were underscreened generated high participation rates (>75%). Substantial interstudy heterogeneity was noted (I 2 >95%). Conclusions: When used with hrHPV assays based on polymerase chain reaction, testing on self samples was similarly accurate as on clinician samples. Offering self sampling kits generally is more effective in reaching underscreened women than sending invitations. However, since response rates are highly variable among settings, pilots should be set up before regional or national roll out of self sampling strategies.
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Written from the paper’s full text.
TL;DR
In updated meta-analyses of 56 diagnostic accuracy studies and 25 randomized participation trials, hrHPV testing on self samples was as sensitive as clinician samples when using PCR-based assays, but less sensitive with signal-amplification assays. Mailing self-sampling kits increased participation among underscreened women, though effects varied substantially by invitation strategy and setting.
Key findings
- PCR-based hrHPV assays on self samples were as sensitive as clinician samples for CIN2+ (pooled ratio 0.99, 95% CI 0.97 to 1.02) and CIN3+ (0.99, 0.96 to 1.02), with slightly lower specificity to exclude CIN2+ (0.98, 0.97 to 0.99).
- Signal-amplification hrHPV assays were less sensitive on self samples for CIN2+ (0.85, 0.80 to 0.89) and CIN3+ (0.86, 0.76 to 0.98), and less specific to exclude CIN2+ (0.96, 0.93 to 0.98).
- In intention-to-treat analysis, mailing self-sampling kits to the home increased participation versus invitation/reminder letters (relative participation 2.33, 95% CI 1.86 to 2.91), whereas opt-in strategies were not significantly more effective (1.22, 0.93 to 1.61).
- Door-to-door delivery generated high participation (>75%; pooled self-sampling participation 94.2% per protocol and 94.6% intention-to-treat), and CIN2+ detection per 1000 invited women was higher in self-sampling arms (relative proportion 2.28, 95% CI 1.44 to 3.61).
Methods
- Updated meta-analyses: accuracy review searched Medline, Embase, and CENTRAL from 1 January 2013 to 15 April 2018; participation review searched from 1 January 2014 to 15 April 2018.
- Included 56 diagnostic test accuracy studies comparing hrHPV testing on vaginal self samples versus clinician samples with CIN2+/CIN3+ verification, and 25 randomized trials of self-sampling offers among irregularly/never-screened women with at least 400 women.
- Pooled accuracy using a bivariate normal model for logit-transformed sensitivity/specificity; pooled participation using random-effects models for proportions and ratios; assessed quality with QUADAS-2 and Cochrane risk-of-bias tools.
Limitations
- Stated: meta-analyses based on aggregated published results lacked detailed data equally stratified by potentially influencing factors; meta-regression including only eight studies did not reveal age effects, and subgroup analyses/meta-regressions were not possible because covariates were categorized differently across studies.
- Stated: the authors propose pooling individual patient data from the best trials to evaluate influential factors more efficiently.
- Evident: substantial interstudy heterogeneity was noted (I²>95%), including high heterogeneity for participation outcomes and opt-in results (P<0.001), and quality reporting was incomplete for some domains, such as uninterpretable results poorly reported for evaluated tests (39%) and reference standard (45%).
Model-written summary. Check it against the paper before relying on it.
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Cites
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Claims the paper makes
14 of 33 cited sources checked · 6 supported · 0 flagged · accuracy not yet measured
- Findingcitation
Participation was not significantly different when hrHPV testing was performed versus when cytology was performed in two Italian studies (P=0.60 v P=0.76).
“The participation was not significantly different when hrHPV testing was performed versus when cytology was performed (P=0.60 v P=0.76).104 117”
Quote in the paperNot a substantial claim2 of 2 sources checked- cites [104] source
The Results (‘Effect on compliance’; page unavailable) report similar participation after invitations for clinic-based HPV testing (14.9%) and standard Pap-test recall (13.9%). The Abstract (‘Results’; page unavailable) explicitly calls the difference nonsignificant. Our copy does not report the cited P=0.60 or P=0.76 values; this paper also accounts for only one of the two studies cited. (LLM, conf=0.83)
Experimental — accuracy not yet measured - cites [117] source
The Results (page unavailable) report no difference in participation between the cytology and HPV clinic-control groups at one centre. However, the reported P value is 0.9, not 0.60 or 0.76; this source does not support the quoted figures or the claim about two studies. (LLM, conf=0.88)
Experimental — accuracy not yet measured
- Premisecitation
A proportion of screened women with cervical precancer and cancer show false negative Pap tests.
“Third, a proportion of screened women with cervical precancer and cancer show false negative Pap tests.18 19”
Quote in the paperSubstantial claim1 of 2 sources checked - Findingcitation
In the Belgian randomized clinical trial, the response rate was 10.5% (95% CI 9.9% to 11.2%) in the control arm with a reminder letter.
“In the first control arm (reminder letter) the response rate was 10.5% (95% confidence interval 9.9% to 11.2%)”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [69] source
The Participation section reports that 931 of 8,830 women (10.5%) in the recall-letter control group had a Pap smear within 12 months. Our copy does not report the claimed 95% confidence interval of 9.9% to 11.2%, although it is consistent with the reported counts. (LLM, conf=0.82)
Experimental — accuracy not yet measured
- Study design and conductcitation
Three (12%) of the 25 trials met the criteria for low risk of bias in all categories.
“Three (12%) of the 25 trials met the criteria for low risk of bias in all categories.114 115 117”
Quote in the paperNot a substantial claim3 of 3 sources checked- cites [114] source
The Design (p. 2) identifies this source as a randomized trial, and Randomization and blinding (p. 4) describes its allocation and blinding procedures. The paper does not assess 25 trials or establish that three met low-risk-of-bias criteria in every category; it supports identifying one trial, not the aggregate claim. (LLM, conf=0.82)
Experimental — accuracy not yet measured - cites [115] source
The Materials and Methods > Design section describes this paper as a single three-group randomised trial, not an assessment of 25 trials. Searches for “25 trials” and “low risk of bias” found no passage in our copy reporting that three trials (12%) met low-risk criteria in all categories. Page numbers were not available in the indexed passages. (LLM, conf=0.77)
Experimental — accuracy not yet measured - cites [117] source
The Methods (Analysis and Study design; page unavailable) describe this paper’s own randomized trial, not an assessment of 25 trials. Searches for “25 trials,” “low risk of bias,” and “three trials 12%” found no passage reporting the claimed count or bias rating. (LLM, conf=0.75)
Experimental — accuracy not yet measured
- Findingcitation
In the Belgian randomized clinical trial, the response rate was 8.0% (95% CI 7.5% to 8.6%) in the control arm with no letter.
“whereas in the second control arm (no letter), the response rate was slightly lower (8.0%, 95% confidence interval 7.5% to 8.6%)”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [69] source
The Participation section reports that 709 women (8%) in the no-intervention arm had a PAP smear within 12 months, and the study description identifies this as the second control group. Our copy does not report the claimed 95% confidence interval of 7.5%–8.6% for that rate; the Statistical analysis section discusses confidence intervals for odds ratios instead. Page numbers are not available for these passages. (LLM, conf=0.86)
Experimental — accuracy not yet measured
- Premisecitation
Two previous participation meta-analyses showed that sending self sampling kits to a woman's home address generated greater response rates than invitation or reminder letters.
“Two previous participation meta-analyses showed that sending self sampling kits to a woman’s home address generated greater response rates than invitation or reminder letters.23 24”
Quote in the paperNot a substantial claim1 of 2 sources checked- cites [23] source
- cites [24] Racey, 2013, Self-collected HPV Testing Improves Participation in Cervical Cancer Screening: A Systematic Review and Meta-analysis, Can.J.Public Health source
The Synthesis in our copy (Abstract; page not specified) reports that this meta-analysis found greater screening participation with self-collected HPV testing than with Pap testing. It does not establish the more specific comparison of kits sent to home addresses against invitation or reminder letters, so that part of the claim is unsupported by the available passages. (LLM, conf=0.76)
Experimental — accuracy not yet measured
- Findingown data
Five studies provided response rates in both trial arms stratified by categories defined on the screening history status.
“We found five studies that provided response rates in both trial arms stratified by categories defined on the screening history status.”
Quote in the paperNot a substantial claim3 of 3 sources checked - Findingown data
In screening studies where partial verification bias was avoided, the specificity of the hrHPV assay based on signal amplification on self samples was significantly lower (83%) than in studies where verification was not avoided or unclear (87%; P=0.03).
“However, in screening studies, where partial verification bias was avoided, the specificity of the hrHPV assay based on signal amplification on self samples was significantly lower (83%) than in studies where verification was not avoided or unclear (87%; P=0.03).”
Quote in the paperNot a substantial claim - Findingnone given
Direct offer of self sampling devices to women in communities that were underscreened generated high participation rates (>75%).
“Direct offer of self sampling devices to women in communities that were underscreened generated high participation rates (>75%).”
Quote in the paperSubstantial claim - Findingown data
hrHPV assays based on polymerase chain reaction were slightly less specific on self samples than clinician samples to exclude CIN2+ (ratio 0.98, 95% CI 0.97 to 0.99).
“hrHPV assays based on polymerase chain reaction were equally sensitive (ratio 0.99, 95% confidence interval 0.97 to 1.02 for CIN2+; 0.99, 0.96 to 1.02 for CIN3+) and slightly less specific (0.98, 0.97 to 0.99 to exclude CIN2+) on self samples versus clinician samples”
Quote in the paperSubstantial claim - Findingown data
hrHPV assays based on polymerase chain reaction were as sensitive on self samples as on clinician samples to detect CIN2+ (pooled ratio 0.99, 95% CI 0.97 to 1.02).
“hrHPV assays based on polymerase chain reaction were equally sensitive (ratio 0.99, 95% confidence interval 0.97 to 1.02 for CIN2+; 0.99, 0.96 to 1.02 for CIN3+) and slightly less specific (0.98, 0.97 to 0.99 to exclude CIN2+) on self samples versus clinician samples”
Quote in the paperSubstantial claim - Findingown data
The pooled sensitivity of hrHPV assays based on polymerase chain reaction on a self sample was similar to a clinician sample for all of the self sampling devices and storage media.
“Table 2 shows that the pooled sensitivity of hrHPV assays based on polymerase chain reaction on a self sample was similar (the 95% confidence interval for the ratio included unity) to a clinician sample for all of the self sampling devices and storage media.”
Quote in the paperSubstantial claim - Findingown data
In screening studies, the pooled absolute specificity to exclude CIN2+ for signal amplification assays was 84% (95% CI 77% to 88%) in self samples and 86% (81% to 90%) in clinician samples.
“The pooled absolute specificity to exclude CIN2+ was 84% (95% confidence interval 77% to 88%) in self samples and 86% (81% to 90%) in clinician samples.”
Quote in the paperSubstantial claim - Findingown data
hrHPV assays based on signal amplification were less sensitive on self samples than clinician samples to detect CIN2+ (pooled ratio 0.85, 95% CI 0.80 to 0.89).
“However, hrHPV assays based on signal amplification were less sensitive on self samples (pooled ratio 0.85, 95% confidence interval 0.80 to 0.89).”
- Also stated in: § Accuracy of hrHPV assay · plain
“Table 1 shows that hrHPV assays based on signal amplification were less sensitive (ratio 0.85, 95% confidence interval 0.80 to 0.89 for CIN2+; 0.86, 0.76 to 0.98 for CIN3+) and less specific (0.96, 0.93 to 0.98 to exclude CIN2+) on self samples versus clinician samples.”
Quote in the paperSubstantial claim - Also stated in: § Accuracy of hrHPV assay · plain
- Findingown data
In screening studies, the pooled absolute sensitivity of hrHPV assays for CIN2+ based on polymerase chain reaction was 96% for both self samples and clinician samples.
“The pooled absolute sensitivity of hrHPV assays for CIN2+ based on polymerase chain reactions was 96% for both self samples and clinician samples.”
Quote in the paperSubstantial claim - Findingown data
In screening studies, the specificity to exclude CIN2+ for PCR assays was similar for both self samples and clinician samples (79%).
“The specificity to exclude CIN2+ was similar for both self samples and clinician samples (79%).”
Quote in the paperSubstantial claim - Findingown data
hrHPV assays based on signal amplification were less specific on self samples than clinician samples to exclude CIN2+ (ratio 0.96, 95% CI 0.93 to 0.98).
“Table 1 shows that hrHPV assays based on signal amplification were less sensitive (ratio 0.85, 95% confidence interval 0.80 to 0.89 for CIN2+; 0.86, 0.76 to 0.98 for CIN3+) and less specific (0.96, 0.93 to 0.98 to exclude CIN2+) on self samples versus clinician samples.”
Quote in the paperSubstantial claim - Findingown data
The pooled sensitivity of hrHPV assays based on signal amplification was 10% to 16% lower on a self sample versus a clinician sample for all self sampling device and storage medium categories.
“Table 2 shows that the pooled sensitivity of hrHPV assays based on signal amplification was 10% to 16% lower on a self sample versus a clinician sample for all self sampling device and storage medium categories.”
Quote in the paperSubstantial claim - Findingown data
In screening studies, the pooled absolute sensitivity of hrHPV assays for CIN2+ based on signal amplification was substantially lower in self samples (77%, 95% CI 69% to 82%) than in clinician samples (93%, 89% to 96%).
“Figure 1 shows that in screening studies, the pooled absolute sensitivity of hrHPV assays for CIN2+ based on signal amplification was substantially lower in self samples (77%, 95% confidence interval 69% to 82%) than in clinician samples (93%, 89% to 96%).”
Quote in the paperSubstantial claim - Findingown data
The relative accuracy of hrHPV assays on self samples versus clinician samples did not vary substantially by clinical setting.
“The relative accuracy of hrHPV assays on self samples versus clinician samples did not vary substantially by clinical setting and therefore we could estimate overall relative sensitivity and specificity under the condition to separate hrHPV assays based on signal amplification from hrHPV assays based on validated polymerase chain reaction.”
Quote in the paperSubstantial claim - Findingown data
hrHPV assays based on polymerase chain reaction were as sensitive on self samples as on clinician samples to detect CIN3+ (pooled ratio 0.99, 95% CI 0.96 to 1.02).
“hrHPV assays based on polymerase chain reaction were equally sensitive (ratio 0.99, 95% confidence interval 0.97 to 1.02 for CIN2+; 0.99, 0.96 to 1.02 for CIN3+) and slightly less specific (0.98, 0.97 to 0.99 to exclude CIN2+) on self samples versus clinician samples”
Quote in the paperSubstantial claim - Findingown data
Mailing self sample kits to the woman's home address generated higher response rates to have a sample taken by a clinician than invitation or reminder letters (pooled relative participation in intention-to-treat-analysis of 2.33, 95% CI 1.86 to 2.91).
“Mailing self sample kits to the woman’s home address generated higher response rates to have a sample taken by a clinician than invitation or reminder letters (pooled relative participation in intention-to-treat-analysis of 2.33, 95% confidence interval 1.86 to 2.91).”
Quote in the paperSubstantial claim - Findingown data
All hrHPV assays were less specific on self samples stored in cell preserving media (9) or virological media (18).
“All hrHPV assays were less specific on self samples stored in cell preserving media (9) or virological media (18).”
Quote in the paperNot a substantial claim - Findingown data
For PCR assays, the positive predictive values for CIN2+ or CIN3+ were not significantly lower for self samples.
“Table 1 shows that the positive predictive values for CIN2+ or CIN3+ were not significantly lower for self samples.”
Quote in the paperSubstantial claim - Findingown data
hrHPV assays based on signal amplification were less sensitive on self samples than clinician samples to detect CIN3+ (pooled ratio 0.86, 95% CI 0.76 to 0.98).
“Table 1 shows that hrHPV assays based on signal amplification were less sensitive (ratio 0.85, 95% confidence interval 0.80 to 0.89 for CIN2+; 0.86, 0.76 to 0.98 for CIN3+) and less specific (0.96, 0.93 to 0.98 to exclude CIN2+) on self samples versus clinician samples.”
Quote in the paperSubstantial claim - Findingown data
Opt-in strategies where women had to request a self sampling kit were generally not more effective than invitation letters (relative participation of 1.22, 95% CI 0.93 to 1.61).
“Opt-in strategies where women had to request a self sampling kit were generally not more effective than invitation letters (relative participation of 1.22, 95% confidence interval 0.93 to 1.61).”
Quote in the paperSubstantial claim - Findingown data
The percentage of women in the self sampling arm that had a hrHPV test done on a self sample, when the self sampling kit was mailed to a woman's home (mail-to-all), varied in the per protocol analysis between 6.4% and 34.0%, with a pooled average of 19.2% (95% CI 15.7% to 23.0%).
“Table 3 and supplementary figure 9 show that the percentage of women in the self sampling arm that had a hrHPV test done on a self sample, when the self sampling kit was mailed to a woman’s home (mail-to-all), varied in the per protocol analysis between 6.4% and 34.0%, with a pooled average of 19.2% (95% confidence interval 15.7% to 23.0%).”
Quote in the paperSubstantial claim - Findingown data
For signal amplification assays, the positive predictive value for CIN3+ was significantly lower on self samples than clinician samples (ratio 0.65, 95% CI 0.57 to 0.78).
“| SA | CIN3+ | 9 | | 0.86 (0.76 to 0.98)* | 0.97 (0.95 to 0.99)* | 1.14 (1.05 to 1.24) | 0.65 (0.57 to 0.78) |”
Quote in the paperSubstantial claim - Findingown data
For signal amplification assays, the positive predictive value for CIN2+ was significantly lower on self samples than clinician samples (ratio 0.71, 95% CI 0.62 to 0.82).
“| SA | CIN2+ | 23 | | 0.85 (0.80 to 0.89)* | 0.96 (0.93 to 0.98)* | 1.14 (1.05 to 1.24) | 0.71 (0.62 to 0.82) |”
Quote in the paperSubstantial claim - Findingown data
Each hrHPV assay based on signal amplification (HC2, careHPV, and Cervista) as well as the hrHPV E6/E7 mRNA test with APTIMA were at least 15% less sensitive for CIN2+ on self samples versus clinician samples.
“Each hrHPV assay based on signal amplification (HC2, careHPV, and Cervista) as well as the hrHPV E6/E7 mRNA test with APTIMA were at least 15% less sensitive for CIN2+ on self samples versus clinician samples.”
Quote in the paperSubstantial claim - Findingown data
Substantial interstudy heterogeneity was noted (I2>95%).
“Substantial interstudy heterogeneity was noted (I2>95%).”
Quote in the paperNot a substantial claim - Findingown data
The absolute specificity of all hrHPV assays on self samples and clinician samples was substantially lower in clinical settings other than screening.
“The absolute specificity of all hrHPV assays on self samples and clinician samples was substantially lower in the other clinical settings than with screening.”
Quote in the paperNot a substantial claim - Findingown data
The relative participation was on average twice as high in the self sampling versus the control arms in the community campaign and door-to-door scenarios.
“The relative participation was on average twice as high in the self sampling versus the control arms in the community campaign and door-to-door scenarios.”
Quote in the paperSubstantial claim - Findingown data
The pooled participation rate was 15.6% (95% CI 12.4% to 19.5%) in one trial where women were invited through community campaigns.
“15.6% (12.4% to 19.5%) in one trial where women were invited through community campaigns”
Quote in the paperNot a substantial claim - Findingown data
The average percentage of women who participated in the control arm was 6.0% (95% CI 4.2% to 8.7%) in the community campaigns scenario.
“6.0% (4.2% to 8.7%) in the community campaigns scenario”
Quote in the paperNot a substantial claim - Findingown data
The relative participation rate was 2.33 times (95% CI 1.86 to 2.91) higher in the self sampling arm versus the control arm in the intention-to-treat analysis of trials with a mail-to-all scenario.
“the relative participation rate was 1.87 times (95% confidence interval 1.43 to 2.44) and 2.33 times (1.86 to 2.91) higher in the self sampling arm versus the control arm of the trials with a mail-to-all scenario, in the per protocol and intention-to-treat analyses, respectively”
Quote in the paperSubstantial claim - Findingown data
In the door-to-door scenario, the pooled participation difference was 39.7% (95% CI 4.0% to 75.4%, range 11% to 64%, I2=99.9%).
“whereas in the door-to-door scenario the pooled difference was 39.7% (95% confidence interval 4.0% to 75.4%, range 11% to 64%, I2=99.9%)”
Quote in the paperSubstantial claim - Findingown data
The relative participation rate was 1.87 times (95% CI 1.43 to 2.44) higher in the self sampling arm versus the control arm in the per protocol analysis of trials with a mail-to-all scenario.
“the relative participation rate was 1.87 times (95% confidence interval 1.43 to 2.44) and 2.33 times (1.86 to 2.91) higher in the self sampling arm versus the control arm of the trials with a mail-to-all scenario, in the per protocol and intention-to-treat analyses, respectively”
Quote in the paperSubstantial claim - Findingown data
In the opt-in scenario, the pooled participation difference was −5.1% (95% CI −10.0% to −0.2%).
“In the opt-in scenario, the pooled difference tended to be negative in several studies and was also lower than zero when trials were pooled (participation difference −5.1%, 95% confidence interval −10.0% to −0.2%)”
Quote in the paperSubstantial claim - Findingown data
In the per protocol analysis of the mail-to-all scenario, the pooled participation difference was 7.3% (95% CI 4.1% to 10.6%, I2=99%).
“in the per protocol analysis of the mail-to-all scenario, the pooled participation difference was 7.3% (95% confidence interval 4.1% to 10.6%, I2=99%)”
Quote in the paperSubstantial claim - Findingown data
The pooled percentage of participating women in the intention-to-treat analysis of the self sampling arm was 17.7% (95% CI 12.3% to 23.9%) in the opt-in scenario.
“The pooled percentage of participating women, in the intention-to-treat analysis of the self sampling arm, was 17.7% (12.3% to 23.9%) in the opt-in scenario”
Quote in the paperSubstantial claim - Findingown data
The average percentage of women who participated in the control arm was 53.3% (95% CI 10.5% to 93.2%) in the door-to-door scenario.
“53.3% (10.5% to 93.2%) in the door-to-door scenario”
Quote in the paperNot a substantial claim - Findingown data
In the per protocol analysis of trials with opt-in scenarios, the average relative participation was lower in the self sampling versus the control arm, although not significantly (0.73, 95% CI 0.51 to 1.04).
“In the per protocol analysis of the trials with opt-in scenarios, the average relative participation was lower in the self sampling versus the control arm, although not significantly (0.73, 95% confidence interval 0.51 to 1.04)”
Quote in the paperNot a substantial claim - Findingown data
For the other scenarios, the intention-to-treat analyses showed similar participation differences as in the per protocol analyses.
“For the other scenarios, the intention-to-treat analyses showed similar participation differences as in the per protocol analyses.”
Quote in the paperNot a substantial claim - Findingown data
In trials with additional Pap tests in the mail-to-all group (intention-to-treat analysis), the overall participation rate ranged from 10.2% to 39.0%, with an average of 24.8% (95% CI 21.6% to 28.1%).
“the overall participation rate was slightly or substantially higher, ranging from 10.2% to 39.0%, with an average rate of 24.8% (21.6% to 28.1%)”
Quote in the paperNot a substantial claim - Findingown data
The average percentage of women who participated in the control arm was 13.4% (95% CI 10.2% to 16.9%) in the opt-in scenario.
“13.4% (10.2% to 16.9%) in the opt-in scenario”
Quote in the paperNot a substantial claim - Findingown data
In the community campaign, the participation difference was 9.5% (95% CI 5.4% to 13.7%).
“In the community campaign, the participation difference was 9.5% (95% confidence interval 5.4% to 13.7%)”
Quote in the paperNot a substantial claim - Findingown data
The pooled participation rate was 94.2% (95% CI 80.2% to 100.0%) when community health workers delivered self sample kits directly to women's homes or workplaces (door-to-door).
“94.2% (80.2% to 100.0%) when community health workers delivered self sample kits directly to women’s homes or workplaces (door-to-door)”
Quote in the paperSubstantial claim - Findingown data
In the intention-to-treat analysis of the opt-in scenario, the participation difference was not significantly different from zero (3.3%, 95% CI −0.7% to 7.3%).
“whereas in the opt-in scenario the difference was not significantly different from zero (participation difference 3.3%, 95% confidence interval −0.7% to 7.3%)”
Quote in the paperNot a substantial claim - Findingown data
The average percentage of women who participated in the control arm was 11.5% (95% CI 8.3% to 15.1%) in the mail-to-all scenario.
“the average percentage of women who participated in the control arm was 11.5% (95% confidence interval 8.3% to 15.1%) in the mail-to-all scenario”
Quote in the paperNot a substantial claim - Findingown data
In the intention-to-treat analysis of the mail-to-all scenario, the pooled participation difference was 12.8% (95% CI 10.4% to 15.1%, range 5% to 30%, I2=97%).
“In the intention-to-treat analysis of the mail-to-all scenario, the pooled participation difference was 12.8% (95% confidence interval 10.4% to 15.1%, range 5% to 30%, I2=97%)”
Quote in the paperSubstantial claim - Findingown data
The pooled participation rate was 7.8% (95% CI 5.2% to 10.9%) when women had to request a self sampling kit (opt-in).
“The pooled participation rate was 7.8% (95% confidence interval 5.2% to 10.9%) when women had to request a self sampling kit (opt-in)”
Quote in the paperSubstantial claim - Findingown data
The pooled percentage of participating women in the intention-to-treat analysis of the self sampling arm was 94.6% (95% CI 83.0% to 99.9%) in the door-to-door scenario.
“and 94.6% (83.0 to 99.9%) in the door-to-door scenario”
Quote in the paperSubstantial claim - Interpretationown data
Response rates are highly variable among settings.
“However, since response rates are highly variable among settings, pilots should be set up before regional or national roll out of self sampling strategies.”
Quote in the paperSubstantial claim - Interpretationown data
When used with hrHPV assays based on polymerase chain reaction, testing on self samples was similarly accurate as on clinician samples.
“When used with hrHPV assays based on polymerase chain reaction, testing on self samples was similarly accurate as on clinician samples.”
Quote in the paperSubstantial claim - Premisecitation
The prevalence of exposure to high-risk human papillomavirus (hrHPV) infection has increased over time.
“First, the prevalence of exposure to the main etiologic factor, high-risk human papillomavirus (hrHPV) infection, has increased over time.13 14”
Quote in the paperNot a substantial claim0 of 2 sources checked - Interpretationown data
Offering self sampling kits generally is more effective in reaching underscreened women than sending invitations.
“Offering self sampling kits generally is more effective in reaching underscreened women than sending invitations.”
Quote in the paperSubstantial claim- Rests on an assumption: Intention-to-treat analyses of participation trials reflect the overall public health effect in a real world situation.
- Study design and conductown data
In most papers, uninterpretable results were poorly reported for the evaluated tests and for the reference standard (39% and 45%, respectively).
“In most papers, uninterpretable results were poorly reported for the evaluated tests and for the reference standard (39% and 45%, respectively).”
Quote in the paperNot a substantial claim - Premisecitation
Screening by hrHPV testing is more effective than screening by cytology for protecting against future cervical precancer and cancer.
“We now have high level evidence that screening by hrHPV testing is more effective than screening by cytology for protecting against future cervical precancer and cancer.18 20”
Quote in the paperSubstantial claim0 of 2 sources checked
- Classified as probably not a substantial claim. 9
- May combine two claims. 19
- The quote only partly states this claim. 2
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationThe authors assessed the quality of randomized clinical trials for the participation review by using the Cochrane Collaboration's tool for risk of bias in randomized trials.
“We assessed the quality of the randomized clinical trials for the participation review by using the Cochrane Collaboration’s tool for risk of bias in randomized trials.30”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [30] source
May combine two claims.
Findingown dataEach hrHPV assay based on polymerase chain reaction was equally sensitive for CIN2+ and for CIN3+ on self samples versus clinician samples.
“Each hrHPV assay based on polymerase chain reaction was equally sensitive for CIN2+ and for CIN3+ on self samples versus clinician samples.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataThe updated meta-analyses comprised 56 diagnostic test accuracy studies and 25 randomized trials.
“56 accuracy studies and 25 participation trials were included.”
- Also stated in: § Results · plain
“The updated meta-analyses finally comprised 56 diagnostic test accuracy studies and 25 randomized trials.”
Quote in the paperNot a substantial claim- Also stated in: § Results · plain
May combine two claims.
Findingown dataIn general, hrHPV assays were less specific on self samples except for the HC2 assay on a tampon self sample (n=1) or an assay based on polymerase chain reaction on a vaginal lavage self sample (2).
“In general, hrHPV assays were less specific on self samples except for the HC2 assay on a tampon self sample (n=1) or an assay based on polymerase chain reaction on a vaginal lavage self sample (2).”
Quote in the paperSubstantial claimThe quote only partly states this claim.
Findingown dataFor signal amplification assays, the test positivity rate was on average 14% higher on self samples than clinician samples (ratio 1.14, 95% CI 1.05 to 1.24).
“The test positivity rate was, on average, 14% higher and the positive predictive value was significantly lower for both CIN2+ and CIN3+ for self samples (positive predictive value< 1).”
Quote in the paperNot a substantial claimThe quote only partly states this claim.
Findingown dataFor PCR assays, the test positivity rate was similar on self samples and clinician samples (ratio 1.00, 95% CI 0.94 to 1.06).
“The test positivity rate was similar in self samples versus clinician samples.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataThe participation difference was nearly always positive except for two studies where the difference was significantly lower than zero.
“The participation difference was nearly always positive except for two studies where the difference was significantly lower than zero.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataIn the intention-to-treat analysis of trials with opt-in scenarios, the pooled relative participation exceeded unity, although not significantly (1.22, 95% CI 0.93 to 1.61).
“whereas on average in the intention-to-treat analysis, the pooled relative participation exceeded unity, although not significantly (1.22, 0.93 to 1.61)”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductown dataThe quality of verification with a reference standard was good in 84%, moderate in 13%, and problematic in 4% of the studies.
“The quality of verification with a reference standard (acceptable validity, blinding toward tests, and avoidance of incorporating test results in final conclusion of disease outcome) was good in 84%, moderate in 13%, and problematic in 4% of the studies.”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductown dataReporting and execution of tests was adequate in 73% and unclear in 27% of the 56 diagnostic studies, and risk of bias was never assessed as high.
“Reporting and execution of tests (description of cut-off, blinding of the index test toward comparator and reference test) was adequate in 73% and unclear in 27%, but the risk of bias was never assessed as high.”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductown dataThe risk of bias for enrolment of women in the 56 diagnostic studies was considered low in 59%, moderate in 39%, and high in 2%.
“The risk of bias for enrolment of women was considered low in 59%, moderate in 39%, and high in 2% of the 56 diagnostic studies (supplementary materials).”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductown dataWithdrawal of patients was explained appropriately in 70%, but not in 18%, and unclear in 12% of the studies.
“Withdrawal of patients was explained appropriately in 70%, but not in 18%, and unclear in 12% of the studies.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe authors assessed the quality of diagnostic studies for the accuracy review by using the QUADAS-2 check list.
“We assessed the quality of the diagnostic studies for the accuracy review by using the QUADAS-2 check list.29”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [29] source
May combine two claims.
Study design and conductown dataThe delay between self sampling, clinician sampling, and verification with the reference standard was short in 61%, unreported in 38%, and long in 2% of the studies.
“The delay between self sampling, clinician sampling, and verification with the reference standard was short in 61%, unreported in 38%, and long in 2% of the studies.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductcitationThe meta-analyses followed PRISMA guidelines for reporting of meta-analyses, and recommendations established by the Cochrane Collaboration for diagnostic test accuracy and intervention trials.
“The meta-analyses followed PRISMA guidelines for reporting of meta-analyses, and recommendations established by the Cochrane Collaboration for diagnostic test accuracy and intervention trials.31 32”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [31] Moher, 2009, Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement, Ann Intern Med source
- cites [32] Deeks, 2013
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
Study design and conductown dataAll trials had complete data for the participation outcome and were therefore at low risk of attrition bias.
“All trials had complete data for the participation outcome and were therefore at low risk of attrition bias.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationRecent trend analyses reveal an increasing burden of cervical cancer, even in countries with well organized screening programs based on cytology and good coverage.
“However, recent trend analyses reveal an increasing burden of cervical cancer, even in countries with well organized screening programs based on cytology and good coverage.8 9 10 11 12”
Quote in the paperNot a substantial claim0 of 3 sources checkedProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationPublication bias was assessed by using Deeks' and Harbord's regression tests for the pooled absolute and relative accuracy estimates, respectively.
“We assessed publication bias by using Deeks' and Harbord's regression tests for the pooled absolute and relative accuracy estimates, respectively.36 37”
Quote in the paperNot a substantial claim0 of 2 sources checkedClassified as probably not a substantial claim. May combine two claims.
PremisecitationThe previous accuracy meta-analysis concluded that hrHPV testing was less sensitive on self samples than on clinician samples, but also found that the reason for lower sensitivity was the use of assays based on signal amplification.
“The previous accuracy meta-analysis concluded that hrHPV testing was less sensitive on self samples than on clinician samples, but also found that the reason for lower sensitivity was the use of assays based on signal amplification.22”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [22] source
May combine two claims.
Study design and conductown dataPartial verification was avoided in 70% but clearly present in 25%, whereas differential verification was absent in 89% but unclear or present in 11% of the studies.
“Partial verification was avoided in 70% but clearly present in 25%, whereas differential verification was absent in 89% but unclear or present in 11% of the studies.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationhrHPV testing can be done on vaginal samples collected by the patient (self samples), whereas cytology on self samples shows poor accuracy.
“hrHPV testing provides another advantage: it can be done on vaginal samples collected by the patient (self samples), whereas cytology on self samples shows poor accuracy.21”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [21] source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenMA and one other author independently performed the study selection and data extraction, and PC judged any unresolvable discordances.
“MA and one other author (SBS, ST, FS, or a Collaboration on Self-Sampling and HPV Testing group member) independently performed the study selection and data extraction. PC judged any unresolvable discordances.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationMost cervical cancer cases occur in women who have never been screened for cervical cancer, or do not participate in routine screening.
“Most cervical cancer cases occur in women who have never been screened for cervical cancer, or do not participate in routine screening.7”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [7] IARC, 2005
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataThe quality of reporting was adequate in 12 trials (48%), incomplete in one trial, and intermediate in the other trials.
“The quality of reporting was adequate in 12 trials (48%),26 67 102 103 104 107 108 109 114 115 116 117 118 incomplete in one trial,106 and intermediate in the other trials.”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductown dataIn eight trials (32%) allocation was random and concealed, in 14 trials (56%) allocation was unclear, and in three trials (12%) allocation was problematic.
“In eight trials (32%) allocation was random and concealed,26 63 64 65 104 114 115 117 in 14 trials (56%) allocation was unclear,66 67 102 103 105 106 107 108 109 110 111 112 113 116 and in three trials (12%) allocation was problematic.62 68 69”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Intention-to-treat analyses of participation trials reflect the overall public health effect in a real world situation.
“In the intention-to-treat analyses, which reflected the overall public health effect in a real world situation, we additionally included women in the experimental arm who had been offered self sampling but choose to have a clinician sample taken instead.”
The paper relies on this without support.
New assays, self sampling devices, storage media, and participation strategies have entered the market since the publication of the two previous meta-analyses, and more accuracy and participation studies have been conducted.
“New assays, self sampling devices, storage media, and participation strategies have entered the market since the publication of these two meta-analyses; and more accuracy and participation studies have been conducted.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
There is promising evidence supporting the potential of a self-sampling approach to increase screening participation in under-screened and never-screened women and the efficacy of a single-dose vaccine to facilitate straightforward implementation of the programs.
“Encouragingly, there is promising evidence supporting the potential of a self-sampling approach to increase screening participation in under-screened and never-screened women and the efficacy of a single-dose vaccine to facilitate straightforward implementation of the programs.[144][145][146]”
From Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. (2024) · cites this paper as [145]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredThe Roche Cobas 4800 assay is known for having relatively high sensitivity compared with other HPV assays.
“as shown by multiple previous studies, the Roche Cobas 4800 assay is known for having a relatively high sensitivity compared with other HPV assays (12, 13, 17).”
From Comparison between the Roche Cobas 4800 Human Papillomavirus (HPV), Abbott RealTime High-Risk HPV, Seegene Anyplex II HPV28, and Novel Seegene Allplex HPV28 Assays for High-Risk HPV Detection and Genotyping in Mocked Self-Samples (2023) · cites this paper as [12]
The Results (Accuracy of hrHPV assay; page unavailable) report high pooled sensitivity for PCR-based HPV assays and lower sensitivity for signal-amplification assays on self samples. The paper does not give a Cobas 4800-specific sensitivity estimate or establish that Cobas is more sensitive than other HPV assays; Cobas 4800 appears in a reference title. (LLM, conf=0.78)
Experimental — accuracy not yet measuredVaginal samples collected via self-collection can detect HPV at levels indicative of CIN2+ as accurately as cervical samples collected using a speculum by a clinician.
“An additional and significant benefit of HPV-based screening is that vaginal samples collected via self-collection, hereafter referred to as self-collection, can detect HPV at levels indicative of precancer of the cervix (cervical intraepithelial neoplasia grade 2 or above—CIN2+) as accurately as cervical samples collected using a speculum by a clinician.8”
From Protocol for a cervical screening implementation trial comparing two approaches for delivering HPV self-collection in low-resource settings in India: a type 3 hybrid cluster randomised controlled trial (SHE-CAN) (2025) · cites this paper as [8]
The Abstract Results and Discussion report that PCR-based HPV assays on self-collected vaginal samples were as sensitive as assays on clinician-collected samples for detecting CIN2+. The claim is broader than the finding: specificity was slightly lower for self-samples, and signal-amplification assays were less sensitive. (LLM, conf=0.90)
Experimental — accuracy not yet measuredPCR-based HPV assays to detect high-risk HPVs are as accurate on HPV self-samples as on clinician-collected samples.
“Polymerase chain reaction (PCR) based HPV assays to detect high-risk HPVs are as accurate on HPV self-samples as the clinician collected samples [8].”
From Performance of HPV Self-Sample Collected by a Novel Kit in Comparison with Clinician Collected Sample for Cervical Cancer Screening (2024) · cites this paper as [8]
Home or community-based screening has been evaluated in many countries and is now part of screening policy and routine practice in many countries, and this has led to improved screening rates among unscreened women.
“This has led to improved screening rates among unscreened women.8 9 16 18 48”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Vaginal-lavage study count differs between text and table
MinorThe text gives a count of two for polymerase-chain-reaction testing on vaginal lavage self samples, but table 2 lists four studies for that category.
“an assay based on polymerase chain reaction on a vaginal lavage self sample (2)”
“| Lavage† | 4 | 0.95 (0.87 to 1.04) | 1.09 (0.91 to 1.30) |”
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Self-citationPooled Analysis of a Self-Sampling HPV DNA Test as a Cervical Cancer Primary Screening Method
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“Mail-to-all Bais 2007 Gok 2010 Giorgi-Rossi 2011 Piana 2011 Szarewski 2011 Virtanen 2011 Wikstrom 2011 Gok 2012 Sancho-Garnier 2013 Haguenoer 2014 Cadman 2015 Giorgi-Rossi 2015 Enerly 2016 Racey 2016 Sultana 2016 Kitchener 2017 Tranberg 2018 Giorgi-Rossi 2011 Giorgi-Rossi 2015 Darlin 2013 Kellen…”
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The IARC Perspective on Cervical Cancer Screening
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Self-citationSelf-sampling for human papillomavirus (HPV) testing: a systematic review and meta-analysis
Yeh, P. T., Kennedy, C. E., Vuyst, H. D., & Narasimhan, M. (2019) · BMJ Global Health · doi:10.1136/bmjgh-2018-001351 · Cited by 328 · see citing works
“Four systematic reviews of randomised trials in the context of population-based screening programmes showed that offering high-risk HPV self-sampling to never-screened and underscreened women increased participation compared with inviting women to have samples taken by health professionals.(12) 14–16 In order to devel…”
BackgroundMethodResultInfluentialMaver, P. J., & Poljak, M. (2019) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2019.09.006 · Cited by 307 · see citing works
Worldwide use of HPV self-sampling for cervical cancer screening
Serrano, B., Ibáñez, R., Robles, C., Peremiquel‐Trillas, P., de Sanjosé, S., & Bruni, L. (2021) · Preventive Medicine · doi:10.1016/j.ypmed.2021.106900 · Cited by 298 · see citing works
2020 list of human papillomavirus assays suitable for primary cervical cancer screening
Arbyn, M., Simon, M., Peeters, E., Xu, L., Meijer, C. J. L. M., Berkhof, J., Cuschieri, K., Bonde, J., Ostrbenk Vanlencak, A., Zhao, F.-H., et al. (2021) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2021.04.031 · Cited by 284 · see citing works
Self-citationCervical cancer prevention and control in women living with human immunodeficiency virus
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Self-citationChanges in Cancer Screening in the US During the COVID-19 Pandemic
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“45 Cervical cancer continues to be a major public health challenge in LMICs, where limited resources and fragile health systems impede access to essential services such as HPV vaccination and primary HPV testing.”
Miller, M. J., Xu, L., Qin, J., et al. (2021) · MMWR Morbidity and Mortality Weekly Report · doi:10.15585/mmwr.mm7004a1 · Cited by 164 · see citing works
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Self-citationCosta, S., Verberckmoes, B., Castle, P. E., & Arbyn, M. (2023) · British Journal of Cancer · doi:10.1038/s41416-022-02094-w · Cited by 139 · see citing works
“The search strategy is identical to the one used in the previous review and is available in the supplementary materials [10].”
MethodInfluentialSelf-citationEun, T. J., & Perkins, R. B. (2020) · Medical Clinics of North America · doi:10.1016/j.mcna.2020.08.006 · Cited by 134 · see citing works
Wentzensen, N., Clarke, M. A., & Perkins, R. B. (2021) · Preventive Medicine · doi:10.1016/j.ypmed.2021.106596 · Cited by 129 · see citing works
“Large metaanalyses have demonstrated similar accuracy of PCR-based HPV testing from self-collected and clinician-collected samples (Arbyn et al., 2018).”
ResultUpdates on cervical cancer prevention
Viveros-Carreño, D. A., Fernándes, A., & Pareja, R. (2023) · International Journal of Gynecological Cancer · doi:10.1136/ijgc-2022-003703 · Cited by 127 · see citing works
The European response to the WHO call to eliminate cervical cancer as a public health problem
Arbyn, M., Gültekin, M., Morice, P., Nieminen, P., Cruickshank, M. E., Poortmans, P. M., Kelly, D. M., Poljak, M., Bergeron, C., Ritchie, D., et al. (2020) · International Journal of Cancer · doi:10.1002/ijc.33189 · Cited by 117 · see citing works
Self-citationArbyn, M., Simon, M., de Sanjosé, S., Clarke, M. A., Poljak, M., Rezhake, R., Berkhof, J. H., Nyaga, V. N., Gültekin, M., Canfell, K., et al. (2022) · The Lancet Oncology · doi:10.1016/s1470-2045(22)00294-7 · Cited by 125 · see citing works
Self-citationProjected time to elimination of cervical cancer in the USA: a comparative modelling study
Burger, E. A., Smith, M. A., Killen, J., Sy, S., Simms, K. T., Canfell, K., & Kim, J. J. (2020) · The Lancet Public Health · doi:10.1016/s2468-2667(20)30006-2 · Cited by 109 · see citing works
Arbyn, M., Castle, P. E., SCHIFFMAN, M. H., Wentzensen, N., Heckman‐Stoddard, B. M., & Sahasrabuddhe, V. V. (2022) · International Journal of Cancer · doi:10.1002/ijc.33967 · Cited by 108 · see citing works
Self-citationSimms, K. T., Keane, A., Nguyen, D. T. N., Caruana, M., Hall, M. T., Lui, G., Gauvreau, C., Demke, O., Arbyn, M., Basu, P., et al. (2023) · Nature Medicine · doi:10.1038/s41591-023-02600-4 · Cited by 105 · see citing works
Self-citationCost-effectiveness studies of HPV self-sampling: A systematic review
Malone, C., Barnabas, R. V., Buist, D. S. M., Tiro, J. A., & Winer, R. L. (2020) · Preventive Medicine · doi:10.1016/j.ypmed.2019.105953 · Cited by 102 · see citing works
“A recent meta-analysis of 19 randomized trials found this “direct mail” method significantly increased screening uptake among underscreened women compared to usual care Pap invitations.[27] “Opt-in” HPV-SS is a variation in which women Malone et al.”
BackgroundResultInfluentialInturrisi, F., Aitken, C. A., Melchers, W. J. G., et al. (2021) · The Lancet Regional Health - Europe · doi:10.1016/j.lanepe.2021.100235 · Cited by 97 · see citing works
“However, that study had a smaller sample size and used a signal amplification test for self-collected samples, which is known to be inferior to target amplification [7].”
BackgroundMethodResultInfluentialWiner, R. L., Lin, J. W., Tiro, J. A., Miglioretti, D. L., Beatty, T. C., Gao, H., Kimbel, K. J., Thayer, C., & Buist, D. S. M. (2019) · JAMA Network Open · doi:10.1001/jamanetworkopen.2019.14729 · Cited by 96 · see citing works
Cancer Screening in the United States During the Second Year of the COVID-19 Pandemic
Star, J., Bandi, P., Siegel, R. L., Han, X., Minihan, A. K., Smith, R. A., & Jemal, A. (2023) · Journal of Clinical Oncology · doi:10.1200/jco.22.02170 · Cited by 92 · see citing works
Advances in cervical cancer prevention: Efficacy, effectiveness, elimination?
Sundström, K., & Elfström, K. M. (2020) · PLoS Medicine · doi:10.1371/journal.pmed.1003035 · Cited by 93 · see citing works
Self-Collection for Cervical Screening Programs: From Research to Reality
Hawkes, D. J., Keung, M. H. T., Huang, Y., McDermott, T. L., Romano, J., Saville, M., & Brotherton, J. M. L. (2020) · Cancers · doi:10.3390/cancers12041053 · Cited by 89 · see citing works
“The meta-analysis by Arbyn [10] determined that careHPV was significantly less sensitive for HPV associated with CIN2+ lesions when a self-collected sample was used rather than a clinician-collected sample.”
BackgroundMethodResultInfluentialCubie, H., & Campbell, C. (2020) · Women s Health · doi:10.1177/1745506520914804 · Cited by 87 · see citing works
Perkins, R. B., Guido, R. L., Saraiya, M., et al. (2021) · Journal of Women s Health · doi:10.1089/jwh.2020.8918 · Cited by 85 · see citing works
Daponte, N., Valasoulis, G., Michail, G., Magaliou, I., Daponte, A.-I., Garas, A., Grivea, I., Bogdanos, D. P., & Daponte, A. (2023) · Cancers · doi:10.3390/cancers15061669 · Cited by 84 · see citing works
“Adequate f-u rates might be influenced by triage policy: studies with direct patient referral exhibit higher attendance at f-u care than studies with a triage policy [21].”
BackgroundMethodInfluentialHuman Papilloma Virus self-sampling performance in low- and middle-income countries
Mulki, A. K., & Withers, M. H. (2021) · BMC Women s Health · doi:10.1186/s12905-020-01158-4 · Cited by 87 · see citing works
The importance of long-term follow up of participants in clinical trials
Cuzick, J. (2023) · British Journal of Cancer · doi:10.1038/s41416-022-02038-4 · Cited by 101 · see citing works
“Several studies have also shown that HPV testing can be done on a vaginal self-sample or a urine sample, and achieves similar sensitivity for high-grade CIN, although specificity was somewhat lower [17].”
BackgroundYang, L. P. H., Boily, M., Rönn, M. M., Obiri‐Yeboah, D., Morhason-Bello, I. O., Méda, N., Lompo, O., Mayaud, P., Pickles, M., Brisson, M., et al. (2023) · PLoS Medicine · doi:10.1371/journal.pmed.1004143 · Cited by 83 · see citing works
Shin, M., Liu, G., Mugo, N., Garcia, P. J., Rao, D. W., Broshkevitch, C. J., Eckert, L. O., Pinder, L. F., Wasserheit, J. N., & Barnabas, R. V. (2021) · Frontiers in Public Health · doi:10.3389/fpubh.2021.670032 · Cited by 84 · see citing works
“…user-friendly, rapid, equipment-free, delivered) (87, 137), and has a point-of-care platform (138), it requires batch testing (106), which enables same-day treatment only under special circumstances, such as health campaigns, and the sensitivity is significantly lower with self-sampling (109).”
Desai, K. T., Befano, B., Xue, Z., Kelly, H. A., Campos, N. G., Egemen, D., Gage, J. C., Rodríguez, A. C., Sahasrabuddhe, V. V., Levitz, D., et al. (2021) · International Journal of Cancer · doi:10.1002/ijc.33879 · Cited by 74 · see citing works
“However, to avoid overtreatment, HPV positivity is best followed by triage testing to identify the minority of HPV infections linked to precancer.(7) Deep learning (DL)-based automated visual evaluation (AVE) of cervical images is emerging as an alternative novel, low-cost screening”
BackgroundMethodArrossi, S., Paolino, M., Laudi, R., Gago, J. E., Campanera, A., Marín, O., Falcón, C., Serra, V., Herrero, R., & Thouyaret, L. (2019) · The Lancet Global Health · doi:10.1016/s2214-109x(19)30048-8 · Cited by 74 · see citing works
Zhao, S., Huang, L., Basu, P. S., Domingo, E. J., Supakarapongkul, W., Ling, W. Y., Ocviyanti, D., Rezhake, R., Qiao, Y., Tay, E. H., et al. (2021) · Cancer Letters · doi:10.1016/j.canlet.2021.10.036 · Cited by 75 · see citing works
Ložar, T., Nagvekar, R., Rohrer, C. T., Mandishora, R. S. D., Ivanuš, U., & Fitzpatrick, M. B. (2021) · International Journal of Women s Health · doi:10.2147/ijwh.s288376 · Cited by 70 · see citing works
“to clinician-collected samples (96%) for detection of CIN2.(9) The improved diagnostic accuracy of self-sampling using PCR-based HPV-testing assays has led to some countries, such as Australia, the Netherlands, and Denmark,(93,94)”
BackgroundMethodResultInfluentialvan den Helder, R., Steenbergen, R. D. M., van Splunter, A., et al. (2022) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-21-3710 · Cited by 70 · see citing works
Pretsch, P. K., Spees, L. P., Brewer, N. T., Hudgens, M. G., Sanusi, B. O., Rohner, E., Miller, E. M., Jackson, S., Barclay, L. B., Carter, A., et al. (2023) · The Lancet Public Health · doi:10.1016/s2468-2667(23)00076-2 · Cited by 70 · see citing works
Cervical cancer prevention in transgender men: a review
Weyers, S., Garland, S. M., Cruickshank, M. E., Kyrgiou, M., & Arbyn, M. (2020) · BJOG An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.16503 · Cited by 68 · see citing works
Self-citationKeer, S. V., Peeters, E., Broeck, D. V., Sutter, P. D., Donders, G. G. G., Doyen, J., Tjalma, W. A. A., Weyers, S., Vorsters, A., & Arbyn, M. (2021) · Gynecologic Oncology · doi:10.1016/j.ygyno.2021.06.010 · Cited by 68 · see citing works
Self-citationCohen, M. A., Powell, A. M., Coleman, J. S., Keller, J. M., Livingston, A. G., & Anderson, J. (2020) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2020.06.006 · Cited by 66 · see citing works
Achieving cervical cancer elimination among Indigenous women
Whop, L. J., Smith, M. A., Butler, T., Adcock, A., Bartholomew, K., Goodman, M. T., Winer, R. L., Milosevic, E., & LAWTON, B. A. (2021) · Preventive Medicine · doi:10.1016/j.ypmed.2020.106314 · Cited by 65 · see citing works
Ørnskov, D., Jochumsen, K. M., Steiner, P., Grunnet, I. M., Lykkebo, A. W., & Waldstrøm, M. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-041512 · Cited by 66 · see citing works
“30 31”
InfluentialGennaro, G. D., Licata, F., Trovato, A., & Bianco, A. (2022) · Frontiers in Public Health · doi:10.3389/fpubh.2022.1003461 · Cited by 68 · see citing works
“found similar results when comparing opt-out self-samplers distribution with a reminder letter/advice from HCP to have a clinician to collect the sample (9).”
BackgroundResultInfluentialPauw, H. D., Donders, G. G. G., Weyers, S., Sutter, P. D., Doyen, J., Tjalma, W. A. A., Broeck, D. V., Peeters, E., Keer, S. V., Vorsters, A., et al. (2021) · Archives of Public Health · doi:10.1186/s13690-021-00667-4 · Cited by 63 · see citing works
“Moreover, randomised participation trials have shown that the offer of a self-sampling kit generates higher response rates than conventional invitations to have a screening specimen taken by a clinician [11].”
BackgroundInfluentialSelf-citationBrandt, T., Wubneh, S. B., Handebo, S., Debalkie, G., Ayanaw, Y., Alemu, K., Jede, F., Doeberitz, M. V. K., & Bussmann, H. (2019) · BMC Public Health · doi:10.1186/s12889-019-7354-4 · Cited by 64 · see citing works
Vink, F. J., Lissenberg-Witte, B. I., Meijer, C. J. L. M., Berkhof, J. H., van Kemenade, F. J., Siebers, A. G., Steenbergen, R. D. M., Bleeker, M. C. G., & Heideman, D. A. M. (2020) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2020.03.018 · Cited by 60 · see citing works
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“Self-sampling has become popular and acceptable among women as this method is convenient, flexible, and can be performed in a variety of settings, while avoiding the need to perform a pelvic examination and the awkwardness, particularly among women in a conservative society [54].”
BackgroundSturt, A. S., Webb, E. L., Phiri, C. R., et al. (2020) · PLoS neglected tropical diseases · doi:10.1371/journal.pntd.0008337 · Cited by 61 · see citing works
“Self-sampling has been used for diagnosis of reproductive tract infections, including human papillomavirus (HPV) [22].”
BackgroundInfluentialGravitt, P. E., Silver, M. I., Hussey, H. M., Arrossi, S., Huchko, M. J., Jerónimo, J., Kapambwe, S. K., Kumar, S., Meza, G., Nervi, L., et al. (2021) · Preventive Medicine · doi:10.1016/j.ypmed.2020.106322 · Cited by 60 · see citing works
“…community or health facilities for primary screening which increases coverage (an even more attractive option in a post-COVID-19 pandemic world), (Arbyn et al., 2018) (2) eliminate the need for speculum exams for 80–90% of women (lower cost, increased acceptability), (de Sanjose and Holme, 2019)…”
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Urine collection in cervical cancer screening – analytical comparison of two HPV DNA assays
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Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits
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Self-citationLong-term CIN3+ risk of HPV positive women after triage with FAM19A4/miR124-2 methylation analysis
Dick, S., Kremer, W. W., Strooper, L. M. A. D., Lissenberg-Witte, B. I., Steenbergen, R. D. M., Meijer, C. J. L. M., Berkhof, J. H., & Heideman, D. A. M. (2019) · Gynecologic Oncology · doi:10.1016/j.ygyno.2019.06.002 · Cited by 53 · see citing works
Cervical screening during the COVID-19 pandemic: optimising recovery strategies
Castañón, A., Rebolj, M., Burger, E. A., de Kok, I. M. C. M., Smith, M. A., Hanley, S. J. B., Carozzi, F. M., Peacock, S. J., & O’Mahony, J. F. (2021) · The Lancet Public Health · doi:10.1016/s2468-2667(21)00078-5 · Cited by 55 · see citing works
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Keer, S. V., Latsuzbaia, A., Broeck, D. V., Sutter, P. D., Donders, G. G. G., Doyen, J., Tjalma, W. A. A., Weyers, S., Arbyn, M., & Vorsters, A. (2022) · Journal of Clinical Virology · doi:10.1016/j.jcv.2022.105271 · Cited by 51 · see citing works
Self-citationGavinski, K., & DiNardo, D. J. (2022) · Medical Clinics of North America · doi:10.1016/j.mcna.2022.10.006 · Cited by 49 · see citing works
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“Also, HC2 is not generally used for self-sampling, as it is slightly less sensitive for detection of precancer than PCR-based HPV test methods [37].”
BackgroundSelf-citationMacDonald, E. J., GELLER, S. E., Sibanda, N., Stevenson, K., Denmead, L., Adcock, A., Cram, F., Hibma, M. H., Sykes, P. H., & LAWTON, B. A. (2020) · Australian and New Zealand Journal of Obstetrics and Gynaecology · doi:10.1111/ajo.13285 · Cited by 50 · see citing works
Cancer Screening in the Coronavirus Pandemic Era: Adjusting to a New Situation
Basu, P. S., Alhomoud, S. J., Taghavi, K., Carvalho, A. L., Lucas, E., & Baussano, I. (2021) · JCO Global Oncology · doi:10.1200/go.21.00033 · Cited by 48 · see citing works
“HPV testing obtained without a gynecologic examination, by women themselves either at home or clinic, provides a reliable result.(17) The kits for self-collection may be sent by post or distributed by the community health workers.”
BackgroundCervical cancer in Nepal: Current screening strategies and challenges
Narasimhamurthy, M., & Kafle, S. U. (2022) · Frontiers in Public Health · doi:10.3389/fpubh.2022.980899 · Cited by 53 · see citing works
Elfström, M. K., Sundström, K., Andersson, S., Bzhalava, Z., Carlsten‐Thor, A., Gzoul, Z., Öhman, D., Lamin, H., Eklund, C., Dillner, J., et al. (2019) · International Journal of Cancer · doi:10.1002/ijc.32374 · Cited by 49 · see citing works
“kits for human papillomavirus (HPV) testing to women has been proposed, with some promising results on attendance.(7)”
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Introduction of HPV testing for cervical cancer screening in Central America: The Scale-Up project
Holme, F., Jerónimo, J., Maldonado, F., et al. (2020) · Preventive Medicine · doi:10.1016/j.ypmed.2020.106076 · Cited by 47 · see citing works
Dutton, T., Marjoram, J., Burgess, S., Montgomery, L., Vail, A., Callan, N., Jacob, S., Hawkes, D. J., Saville, M., & Bailey, J. (2020) · BMC Health Services Research · doi:10.1186/s12913-020-05214-5 · Cited by 49 · see citing works
Cervical cancer risk profiling: molecular biomarkers predicting the outcome of hrHPV infection
Molina, M. A., Diatricch, L. C., Quintana, M. C., et al. (2020) · Expert Review of Molecular Diagnostics · doi:10.1080/14737159.2020.1835472 · Cited by 44 · see citing works
Creagh, N. S., Zammit, C. M., Brotherton, J. M. L., Saville, M., McDermott, T. L., Nightingale, C. E., & Kelaher, M. (2021) · The Medical Journal of Australia · doi:10.5694/mja2.51137 · Cited by 44 · see citing works
Cervical Cancer Screening Recommendations: Now and for the Future
Rayner, M., Welp, A. M., Stoler, M. H., & Cantrell, L. A. (2023) · Healthcare · doi:10.3390/healthcare11162273 · Cited by 55 · see citing works
“Newer advancements in HPV testing have led to the development of selfcollected sampling modalities that have been found to have similar rates of accuracy when compared to clinician-collected tests [40].”
BackgroundResultAasbø, G., Tropé, A., Nygård, M., Christiansen, I. K., Baasland, I., Iversen, G. A., Munk, A. C., Christiansen, M. H., Presthus, G. K., Undem, K., et al. (2022) · British Journal of Cancer · doi:10.1038/s41416-022-01954-9 · Cited by 45 · see citing works
“When used with HPV assays based on polymerase chain reaction (PCR), selfsampling and HPV testing identifies women with cervical precancer and cancer, cervical intraepithelial neoplasia grade 2 or more severe diagnoses (CIN2+), with similar accuracy as clinician-collected samples [15, 16].”
BackgroundMethodResultInfluentialSelf-citationSecondary Prevention of Cervical Cancer: ASCO Resource–Stratified Guideline Update
Shastri, S. S., Temin, S., Almonte, M., Basu, P. S., Campos, N. G., Gravitt, P. E., Gupta, V., Lombe, D. C., Murillo, R., Nakisige, C., et al. (2022) · JCO Global Oncology · doi:10.1200/go.22.00217 · Cited by 42 · see citing works
Self-citationCervical Cancer Screening—Past, Present, and Future
Wentzensen, N., & Clarke, M. A. (2021) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-20-1628 · Cited by 42 · see citing works
“Results from a large meta-analysis have demonstrated similar accuracy of HPV testing using PCR-based HPV tests from selfcollected samples and clinician-collected samples (14).”
Urine HPV in the Context of Genital and Cervical Cancer Screening—An Update of Current Literature
Daponte, A. I., Michail, G., Daponte, A., Daponte, A., & Valasoulis, G. (2021) · Cancers · doi:10.3390/cancers13071640 · Cited by 47 · see citing works
“Implementing sensitive screening modalities combined with easy sampling methods with minimal pain or discomfort bypassing the doctors’ visit, such as self-sampling of vaginal and urine samples, is feasible and possibly cost-effective [18].”
BackgroundInfluentialSmith, M. A., Burger, E. A., Castañón, A., de Kok, I. M. C. M., Hanley, S. J. B., Rebolj, M., Hall, M. T., Jansen, E. E. L., Killen, J., O'Farrell, X., et al. (2021) · Preventive Medicine · doi:10.1016/j.ypmed.2021.106623 · Cited by 43 · see citing works
“Self-sampling is also more acceptable to under- and never-screened women than clinician collection, and so provides a tool to reach the women most vulnerable to screening disruptions (Arbyn et al., 2018).”
BackgroundTesting for Human Papillomaviruses in Urine, Blood, and Oral Specimens: an Update for the Laboratory
Poljak, M., Cuschieri, K. S., Alemany, L., & Vorsters, A. (2023) · Journal of Clinical Microbiology · doi:10.1128/jcm.01403-22 · Cited by 42 · see citing works
Arbyn, M., Costa, S., Latsuzbaia, A., Kellen, E., Rossi, P. G., Cocuzza, C. E., Basu, P. S., & Castle, P. E. (2023) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-22-1041 · Cited by 41 · see citing works
Self-citationPatterns in the prevalence and wealth-based inequality of cervical cancer screening in India
Muthuramalingam, M. R., & Muraleedharan, V. R. (2023) · BMC Women's Health · doi:10.1186/s12905-023-02504-y · Cited by 40 · see citing works
Preventive care recommendations to promote health equity
Persaud, N., Sabir, A., Woods, H., Sayani, A., Agarwal, A., Chowdhury, M., de Leon-Demare, K., Ibezi, S., Jan, S. H., Katz, A., et al. (2023) · Canadian Medical Association Journal · doi:10.1503/cmaj.230237 · Cited by 42 · see citing works
Dick, S., Verhoef, L., Strooper, L. M. A. D., Ciocănea‐Teodorescu, I., Wisman, G. B. A., Meijer, C. J. L. M., Bleeker, M. C. G., Steenbergen, R. D. M., & Heideman, D. A. M. (2020) · Epigenomics · doi:10.2217/epi-2019-0331 · Cited by 39 · see citing works
Macios, A., & Nowakowski, A. M. (2022) · Diagnostics · doi:10.3390/diagnostics12061508 · Cited by 38 · see citing works
“Recently published studies suggested that proper test selection for self-sampling results in a sensitivity comparable with cliniciansampling; therefore, sampling errors will be of less importance [114].”
BackgroundBarriers to Cervical Cancer Screening: A Systematic Review
Farajimakin, O. (2024) · Cureus · doi:10.7759/cureus.65555 · Cited by 38 · see citing works
“These methods can increase access to screening for women who face geographical, cultural, or personal barriers to clinic-based screening [18].”
What is needed now for successful scale-up of screening?
de Sanjosé, S., & Holme, F. (2019) · Papillomavirus Research · doi:10.1016/j.pvr.2019.04.011 · Cited by 38 · see citing works
“Implementing self-sampling(4) of vaginal cells allows accurate detection of HPV infection and provides an opportunity to maximize coverage in low-resource settings compared to provider-collected samples of cervical cells [8,9].”
BackgroundZhao, X., Xu, X., Duan, X., Rezhake, R., Hu, S., Wang, Y., Xia, C., Zhang, X., Qiao, Y., Sankaranarayanan, R., et al. (2020) · International Journal of Cancer · doi:10.1002/ijc.32881 · Cited by 38 · see citing works
“0%) of clinically validated PCR HPV tests on self-samples.(6) Our study underlines the current understanding that a PCR-based HPV test is superior to signal amplification-based test in self-sampling based screening and demonstrated that PCR-based HPV test is potentially doable in rural China.”
Background
- Authors
- Arbyn, M., Smith, S. B., Temin, S., Sultana, F., & Castle, P.
- Affiliations
- Sciensano (Belgium) (BE)
- American Society of Clinical Oncology (US)
- The University of Melbourne (AU)
- Albert Einstein College of Medicine (US)
- Corresponding author
- Arbyn, Marc
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2018-12-05
- Volume
- 363
- Pages
- k4823
- ISSN
- 1756-1833 (ISSN-L)
- 0959-8138
- PMC
- PMC6278587
- OpenAlex
- W2902810541
- Semantic Scholar
- 19a6b46f3981556042ef796240496a98ab9d26f6
- Cited by
- 851
- References
- 130
- Citations by year
- 2026: 93 · 2025: 136 · 2024: 136 · 2023: 137 · 2022: 116 · 2021: 104 · 2020: 89 · 2019: 39
- FWCI
- 39.55
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- BMJ (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (submittedVersion, other-oa)
- PubMed Central (submittedVersion, cc-by-nc)
- HighWire Press Open Archive (submittedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Keywords
- cervical cancer screening, HPV testing, self-sampling, cervical intraepithelial neoplasia, CIN2+ detection, diagnostic accuracy, underscreened women, screening uptake, reminder letters, clinician-collected samples, community-based screening
- MeSH terms
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Colposcopy, Female, Humans, Mass Screening, Sensitivity and Specificity, Specimen Handling, Vagina, Vaginal Smears, Incidence, Randomized Controlled Trials as Topic, Papillomaviridae, Papillomavirus Infections, Early Detection of Cancer, Intention to Treat Analysis
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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