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

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+
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‰)
	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
	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‰)
		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
	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‰)
		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
	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%)
			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
	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%)
			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
	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
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