Randomised trial of HPV self-sampling among non-attenders in the Slovenian cervical screening programme ZORA: comparing three different screening approaches

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

doi:10.2478/raon-2018-0036

Figures & Tables

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+
Positive result of HPV test on self-collected sample
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

Concordant 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‰)
ALL WOMEN	Responders		8,972	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‰)
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‰)
	I1 opt-in	responders	4,896	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‰)

	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‰)
	I2 opt-out	responders	3,598	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‰)

	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‰))
	P control	responders	478	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‰))

	p-value		< 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‰)
	Celje	responders	3,666	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‰)

	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‰)
	Maribor	responders	5,306	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‰)

	p-value		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‰)
	Medium	responders	6,367	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‰)

	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‰)
	No/low	responders	2,605	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‰)

	p-value		< 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%)
	I1 opt-in	responders	3,501	51.5% (50.3%–52.7%)	1,395	18.3% (17.5%–19.2%)

	I2 opt-out	all	4,540	54.8% (53.3%–56.2%)	5,016	22.2% (21.0%–23.3%)
	I2 opt-out	responders	2,486	54.8% (53.3%–56.2%)	1,112	22.2% (21.0%–23.3%)

	P control	all	1,128	33.7% (30.9%–36.5%)	1,472	6.7% (5.5%–8.1%)
	P control	responders	380	33.7% (30.9%–36.5%)	98	6.7% (5.5%–8.1%)

	p-value		< 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%)
	Celje	responders	2,700	50.4% (49.0%–51.7%)	966	17.0% (16.0%–18.0%)

	Maribor	all	7,103	51.6% (50.5%–52.8%)	8,398	19.5% (18.7%–20.4%)
	Maribor	responders	3,667	51.6% (50.5%–52.8%)	1,639	19.5% (18.7%–20.4%)

	p-value		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

Age	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)

Level of protection
medium	12,464	46.9	6,796	4,540	1,128	0.001 Statistically significant result at α = 0.05.
no/low	14,092	53.1	7,604	5,016	1,472	0.001 Statistically significant result at α = 0.05.

Region
Celje	11,055	41.6	5,996	3,984	1,075	0.951
Maribor	15,501	58.4	8,404	5,572	1,525	0.951

Randomised trial of HPV self-sampling among non-attenders in the Slovenian cervical screening programme ZORA: comparing three different screening approaches

Figures & Tables

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

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

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

Characteristics of women enrolled in the study

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