Randomised trial of HPV self-sampling among non-attenders in the Slovenian cervical screening programme ZORA: comparing three different screening approaches
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About this article
Article Category: Research Article
Published Online: Sep 14, 2018
Page range: 399 - 412
Received: May 20, 2018
Accepted: Jul 13, 2018
DOI: https://doi.org/10.2478/raon-2018-0036
© 2018 Urska Ivanus, Tine Jerman, Alenka Repse Fokter, Iztok Takac, Veronika Kloboves Prevodnik, Mateja Marcec, Ursula Salobir Gajsek, Maja Pakiz, Jakob Koren, Simona Hutter Celik, Kristina Gornik Kramberger, Ulrika Klopcic, Rajko Kavalar, Simona Sramek Zatler, Biljana Grcar Kuzmanov, Mojca Florjancic, Natasa Nolde, Srdjan Novakovic, Mario Poljak, Maja Primic Zakelj, published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.
Figure 1
Figure 2
Positive predictive value (PPV) of HPV test for CIN2+ and CIN3+ in women who had undergone colposcopy after a positive HPV test on self-collected sample and in women with concordant results of both HPV tests. Results are stratified by the level of protection due to previous screening
| Number of women with | PPV | |||||
|---|---|---|---|---|---|---|
| all | colposcopy | CIN2+ | CIN3+ | CIN2+ | CIN3+ | |
| all women | 430 | 333 | 40 | 32 | 12.0% | 9.6 |
| women with medium protection | 279 | 223 | 18 | 12 | 8.1% | 5.4 |
| women with no/low protection | 151 | 110 | 22 | 20 | 20.0% | 18.2 |
Results of HPV tests were concordant, if HPV test on self-collected sample as well as sample taken by a practitioner were positive. | ||||||
| all women | na Results not available (na), since only women with colposcopy had a sample taken by a practitioner. | 146 | 34 | 29 | 23.3% | 19.9 |
| women with medium protection | na | 97 | 14 | 10 | 14.4% | 10.3 |
| women with no/low protection | na | 49 | 20 | 19 | 40.8% | 38.8 |
The main results by their predictors. Intention-to-screen response rates, the mean age of responders and histological outcomes are presented as absolute numbers, proportions (per 100 or 1.000) and 95% confidence intervals (CI) by the study group, the region of residence and the level of protection
| Number of women | Intention to screen response rate per 100 (%) with 95% CI | Mean age (95% CI) of responders | Intetion to screen histology outcome | ||||||
|---|---|---|---|---|---|---|---|---|---|
| HSIL/CIN2+ | HSIL/CIN3+ | ||||||||
| no. | per 1000 (‰) with 95% CI | no. | per 1000 (‰) with 95% CI | ||||||
| ALL WOMEN | All women | 26,556 | 33.8% (33.2%.34.4%) | 49.0 (48.7-49.2) | 94 | 3.5‰ (2.9‰–4.4‰) | 71 | 2.7‰ (2.1‰–3.4‰) | |
| Responders | 8,972 | ||||||||
| STUDY GROUPS | I1 opt-in | all | 14,400 | 34.0% (33.2%–34.8%) | 49.0 (48.7-49.3) | 49 | 3.4‰ (2.5‰–4.5‰) | 36 | 2.5‰ (1.8‰–3.5‰) |
| responders | 4,896 | ||||||||
| I2 opt-out | all | 9,556 | 37.7% (36.7%–38.6%) | 49.0 (48.6-49.3) | 37 | 3.9‰ (2.8‰–5.4‰) | 30 | 3.1‰ (2.2‰–4.5‰) | |
| responders | 3,598 | ||||||||
| P control | all | 2,600 | 18.4% (16.9%–19.9%) | 48.0 (47.2-48.9) | 8 | 3.1‰ (1.4‰–6.3‰) | 5 | 1.9‰ (0.7‰–4.8‰)) | |
| responders | 478 | ||||||||
| < 0.000 Statistically significant result at α = 0.05. | 0.766 | 0.557 | |||||||
| REGION | Celje | all | 11,055 | 33.2% (32.3%–34.0%) | 48.3 (47.9-48.6) | 38 | 3.4‰ (2.5‰–4.8‰) | 28 | 2.5‰ (1.7‰–3.7‰) |
| responders | 3,666 | ||||||||
| Maribor | all | 15,501 | 34.2% (33.5%–35.0%) | 49.4 (49.2-49.7) | 56 | 3.6‰ (2.8‰–4.7‰) | 43 | 2.8‰ (2.0‰–3.8‰) | |
| responders | 5,306 | ||||||||
| 0.070 | 0.813 | 0.708 | |||||||
| LEVEL OF PROTECTION | Medium | all | 12,464 | 51.1% (50.2%–52.0%) | 48.4 (48.2-48.7) | 48 | 3.9‰ (2.9‰–5.1‰) | 33 | 2.6‰ (1.9‰–3.8‰) |
| responders | 6,367 | ||||||||
| No/low | all | 14,092 | 18.5% (17.8%–19.1%) | 51.1 (50.9-51.3) | 46 | 3.3‰ (2.4‰–4.4‰) | 38 | 2.7‰ (1.9‰–3.7‰) | |
| responders | 2,605 | ||||||||
| < 0.000 Statistically significant result at α = 0.05. | 0.422 | 0.838 | |||||||
Response rate stratified by the level of protection due to previous screening. Intention-to-screen response rates are presented as absolute numbers, proportions (per 100) and 95% confidence intervals (CI) by the study group and the region of residence
| Level of protection | |||||||
|---|---|---|---|---|---|---|---|
| Medium | No/low | ||||||
| Number of women | Response rate per 100 (%) with 95% CI | Number of women | Response rate per 100 (%) with 95% CI | ||||
| STUDY GROUPS | I1 opt-in | all | 6,796 | 51.5% (50.3%–52.7%) | 7,604 | 18.3% (17.5%–19.2%) | |
| responders | 3,501 | 1,395 | |||||
| I2 opt-out | all | 4,540 | 54.8% (53.3%–56.2%) | 5,016 | 22.2% (21.0%–23.3%) | ||
| responders | 2,486 | 1,112 | |||||
| P control | all | 1,128 | 33.7% (30.9%–36.5%) | 1,472 | 6.7% (5.5%–8.1%) | ||
| responders | 380 | 98 | |||||
| < 0.000 Statistically significant result at α = 0.05. | < 0.000 Statistically significant result at α = 0.05. | ||||||
| REGION | Celje | all | 5,361 | 50.4% (49.0%–51.7%) | 5,694 | 17.0% (16.0%–18.0%) | |
| responders | 2,700 | 966 | |||||
| Maribor | all | 7,103 | 51.6% (50.5%–52.8%) | 8,398 | 19.5% (18.7%–20.4%) | ||
| responders | 3,667 | 1,639 | |||||
| 0.163 | < 0.000 Statistically significant result at α = 0.05. | ||||||
Characteristics of women enrolled in the study
| All randomly selected and allocated women | Total | STUDY GROUPS | ||||
|---|---|---|---|---|---|---|
| Number | I1 opt-in | I2 opt-out | P control | P-value | ||
| Number | 26,556 | 100.0 | 14,400 | 9,556 | 2,600 | |
| 49.8 (49.7-50.0) | 49.8 (49.7-50.0) | 49.8 (49.6-50.0) | 50.0 (49.6-50.3) | |||
| Mean age (95% CI) | ||||||
| medium | 12,464 | 46.9 | 6,796 | 4,540 | 1,128 | Statistically significant result at α = 0.05. |
| no/low | 14,092 | 53.1 | 7,604 | 5,016 | 1,472 | |
| Celje | 11,055 | 41.6 | 5,996 | 3,984 | 1,075 | |
| Maribor | 15,501 | 58.4 | 8,404 | 5,572 | 1,525 | |