An adverse event in a well-established cervical cancer screening program: an observational study of 19,000 females unsubscribed to the program

Figures & data

Figure 1 Identification of affected females in the CDR.

Abbreviation: CDR, Central Denmark Region.

Table 1 Test activity and results for 4,783 unsubscribed females (23–64 years) reassigned to the screening program

Age	Number of years unsubscribed		Tested after reassignment, n (% of reassigned)	Result of cytology, n (% of tested)
Total
23–64 years (n=4,783)	Range	5.8–32.7	2,660 (55.6)	Normal	2,516 (94.6)
	Mean	13.1		ASCUS	65 (2.4)
	Median	13.0		ASC-H	26 (1.0)
				AGC	4 (0.2)
				LSIL	14 (0.5)
				HSIL+a	26 (1.0)
				Inadequate	9 (0.3)
Age groups
<45 years (n=1,457)	Range	5.8–26.5	854 (58.6)	Normal	802 (93.9)
	Mean	11.8		ASCUS	25 (2.9)
	Median	11.3		ASC-H	6 (0.7)
				AGC	1 (0.1)
				LSIL	7 (0.8)
				HSIL+a	13 (1.5)
				Inadequate	0 (0)
45–54 years (n=1,457)	Range	6.0–32.5	826 (56.7)	Normal	778 (94.2)
	Mean	13.4		ASCUS	27 (3.3)
	Median	13.2		ASC-H	5 (0.6)
				AGC	3 (0.4)
				LSIL	4 (0.5)
				HSIL+a	7 (0.9)
				Inadequate	2 (0.2)
55–64 years (n=1,869)	Range	5.8–32.7	980 (52.4)	Normal	936 (95.5)
	Mean	13.9		ASCUS	13 (1.3)
	Median	13.7		ASC-H	15 (1.5)
				AGC	0 (0)
				LSIL	3 (0.3)
				HSIL+a	6 (0.6)
				Inadequate	7 (0.7)

Notes: A total of 6,101 females were informed about the adverse event. Of these, 1,318 reconfirmed their wish not to be part of the screening program. Test activity is reported for the remaining 4,783.

a HSIL and carcinoma.

Abbreviations: ASCUS, atypical squamous cells of undetermined significance; ASC-H, atypical squamous cells – cannot exclude HSIL; AGC; atypical glandular cells of undetermined significance; LSIL, low grade squamous intraepithelial lesion; HSIL, high grade squamous intraepithelial lesion.

Table 2 Test activity and results for 8,868 females (64+ years) offered a final screening test analyzed for hrHPV

Age	Number of years unsubscribed		Accepting final screening, n (% of offered)	Result of hrHPV testa, n (% of tested)
Total
64+ years (n=8,868)	Range	5.8–32.8	1,124 (12.7)	Normal	1,012 (90.0)
	Mean	15.3		HPV 16/18	12 (1.1)
	Median	15.0		HPV other typesb	47 (4.2)
				HPV not performed	53 (4.7)
Age groups
65–69 years (n=2,892)	Range	5.8–32.5	592 (20.5)	Normal	549 (92.7)
	Mean	13.9		HPV 16/18	8 (1.4)
	Median	13.7		HPV other typesa	27 (4.6)
				HPV not performed	8 (1.4)
70–74 years (n=2,058)	Range	6.1–32.6	339 (16.5)	Normal	315 (92.9)
	Mean	15.3		HPV 16/18	2 (0.6)
	Median	14.6		HPV other typesa	15 (4.4)
				HPV not performed	7 (2.1)
75–79 years (n=1,367)	Range	6.1–32.0	103 (7.5)	Normal	96 (93.2)
	Mean	16.6		HPV 16/18	2 (1.9)
	Median	15.3		HPV other typesa	3 (2.9)
				HPV not performed	2 (1.9)
80+ years (n=2,551)	Range	6.5–32.8	90 (3.5)	Normal	52 (57.8)
	Mean	16.4		HPV 16/18	0 (0)
	Median	15.5		HPV other typesa	2 (2.2)
				HPV not performed	36 (40.0)

Notes:

a Tests analyzed outside CDR were not analyzed for hrHPV.

b hrHPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.

Abbreviations: hrHPV, high-risk human papillomavirus; HPV, human papillomavirus.

Table 3 Overview of 85 injuries reported to the Danish Patient Compensation Association, adjudications and compensations.

Adjudication	N (%)
Rejected	66 (77.6)
Compensateda	19 (22.4)
Compensations	Amount (DKK/€b)
Total	5,197,462/693,000
Min-max	66,415-1,797,943/8,900–239,700
Mean	273,551/36,500

Notes:

a Including two cases that were rejected in the Danish Patient Compensation Association and reversed by the National Agency for Patients’ Rights and Complaints.

b Rounded off to the nearest 100.

Abbreviations: DKK, Danish krone; €, euro; Min–max, minimum–maximum.

Figure 2 Coverage of cervical cancer screening in the mass media from July 2013 to March 2014.

Abbreviation: HPV, human papillomavirus.

Table S1 Classification of total hysterectomy, cervical cytology, and hrHPV results

Total hysterectomy	ICD8		ICD10
ICD codes	61020, 61040, 61050, 61100, 61780, 62300, 72230, 72240, 72650		KLCD00, KLCD01, KLCD04, KLCD10, KLCD11, KLCD30, KLCD31, KLCD40, KLDC13, KLDC20, KLDC23, KLCD96, KLCD97, KLEF00B, KLEF13, KMCA33
Cervix cytology*	Normal	ASCUS, ASC-H, AGC	LSIL	HSIL+	Inadequate
SNOMED codes	M00120	M67014	M67016	M67017	M09010
	M00121	M67010		M80102
	M00122	M67020		M81402
				M80103
				M80703
				M81403
hrHPV test**	HPV16	HPV18	Other hrHPV types***	hrHPV negative	Inadequate
SNOMED codes	FY5006	FY5006	FY5009	FY5001	M0901H
	Æ33416	Æ33418	FY5010	FY5003
				FY5005

Notes:

* Bethesda;

** Cobas 4800 results;

*** HPV31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.

Abbreviations: hrHPV, high-risk human papillomavirus; ICD, International Classification of Diseases; ASCUS, atypical squamous cells of undetermined significance; ASC-H, atypical squamous cells – cannot exclude HSIL; AGC, atypical glandular cells of undetermined significance; LSIL, Low grade squamous intraepithelial lesion; HSIL+, high-grade squamous intraepithelial lesion/carcinoma in situ/adenocarcinoma in situ/carcinoma/planocellular carcinoma/adenocarcinoma.