Background: State Trait Anxiety Inventory (STAI) scale was developed in the 1980’s and has been widely used both in clinical settings and in research. However the Danish version of STAI has not been validated. The aim of this study was to assess the validity and reliability of STAI - state anxiety scale in Danish women aged 45 years and older with abnormal cervical cancer screening results. Methods: Women ≥45 years referred with an abnormal cervical cytology and healthy volunteers (n = 12) underwent cognitive interview after completing STAI. Further, STAI was sent out in an electronic questionnaire to women (n = 109) seen at the gynecological department with abnormal cervical cancer screening test during 2018. Validity and reliability of STAI was evaluated according to the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist by examining internal consistency, test-retest reliability, measurement error, floor and ceiling, construct validity and content validity. Results: In the cognitive interviews the content validity was evaluated to be very good. The internal consistency of the scale was excellent with Cronbach’s α = 0.93. Test-retest reliability was good with an intra-class correlation coefficient of 0.80 and the systematic difference between test-retest results was negligible. The construct validity was good. Conclusion: To our best knowledge, this is the first validation study of the Danish translation of STAI-state anxiety scale. This version of STAI demonstrates an acceptable reliability and validity when used in a gynecological setting.
26 April 2022 in Acta Obstetricia et Gynecologica Scandinavica
Introduction: In this review and meta‐analysis we aimed to investigate whether human papilloma virus (HPV) vaccination administered after excisional treatment of cervical intraepithelial neoplasia (CIN) is associated with a reduced risk of recurrence of CIN grade 2 or worse (CIN2+).Material and methods: We performed a systematic literature search in three online databases through June 2021. Observational studies and randomized controlled trials (RCTs) were eligible for inclusion if the prophylactic HPV vaccine was administered after excisional treatment for histologically verified CIN. Only English language literature was included. The primary outcome measure was recurrence of CIN2+ after treatment. A meta‐analysis was performed using fixed and random‐effects models, and results were reported as pooled odds ratios (OR) with 95% confidence intervals (95% CI). Quality assessment was performed using ROB2‐tool for RCTs and ROBINS‐I for observational studies. The protocol was registered in PROSPERO (CRD42021238257).Results: A total of 1561 studies were identified, of which nine, including 19 971 women, were included. Two studies were RCTs and seven were observational studies. Using the fixed‐effect model on the two RCTs, the OR for recurrence of CIN2+ was 0.29 (95% CI 0.16–0.53). Due to considerable heterogeneity in observational studies, the random‐effects model was used to estimate pooled OR for CIN2+ recurrence in these studies. Thus, using unadjusted data from observational studies, the OR for CIN2+ recurrence was 0.35 (95% CI 0.18–0.67), whereas when using adjusted data, the OR for CIN2+ recurrence was 0.54 (95% CI 0.21–1.35). However, quality assessment revealed a serious risk of bias for the majority of the studies included.Conclusions: HPV vaccination post‐treatment was associated with a significantly reduced risk of CIN2+ recurrence when using unadjusted estimates from observational studies and RCTs. We found no significant effect of HPV vaccination on risk of CIN2+ recurrence when using the outcome measure from observational studies with the least risk of bias. Large, well‐designed randomized placebo‐controlled trials are needed to determine whether post‐treatment HPV vaccination should be recommended to all women undergoing excisional treatment for CIN.
25 January 2023 in Acta Obstetricia et Gynecologica Scandinavica
Introduction: We identified risk factors and outcomes associated with SARS‐CoV‐2 infection in pregnancy in a universally tested population according to disease severity and validated information on SARS‐CoV‐2 during pregnancy in national health registers in Denmark.Material and methods: Cohort study using data from national registers and medical records including all pregnancies between March 1, 2020 and February 28, 2021. We compared women with a validated positive SARS‐CoV‐2 test during pregnancy with non‐infected pregnant women. Risk factors and pregnancy outcomes were assessed by Poisson and Cox regression models and stratified according to disease severity defined by hospital admission status and admission reason (COVID‐19 symptoms or other). Using medical record data on actual period of pregnancy, we calculated predictive values of the SARS‐CoV‐2 diagnosis in pregnancy in the registers.Results: SARS‐CoV‐2 infection was detected in 1819 (1.6%) of 111 185 pregnancies. Asthma was associated with infection (relative risk [RR] 1.63, 95% confidence interval [CI] 1.28–2.07). Risk factors for severe COVID‐19 disease requiring hospital admission were high body mass index (median ratio 1.06, 95% CI 1.04–1.09), asthma (RR 7.47, 95% CI 3.51–15.90) and gestational age at the time of infection (gestational age 28–36 vs < 22: RR 3.53, 95% CI 1.75–7.10). SARS‐CoV‐2‐infected women more frequently had hypertensive disorders in pregnancy (adjusted hazard ratio [aHR] 1.31, 95% CI 1.04–1.64), early pregnancy loss (aHR 1.37, 95% CI 1.00–1.88), preterm delivery before gestational age 28 (aHR 2.31, 95% CI 1.01–5.26), iatrogenically preterm delivery before gestational age 37 (aHR 1.49, 95% CI 1.01–2.19) and small‐for‐gestational age children (aHR 1.28, 95% CI 1.05–1.54). The associations were stronger among women admitted to hospital for any reason. The validity of the SARS‐CoV‐2 diagnosis in relation to pregnancy in the registers compared with medical records showed a negative predictive value of 99.9 (95% CI 99.9–100.0) and a positive predictive value of 82.1 (95% CI 80.4–83.7).Conclusions: Women infected with SARS‐CoV‐2 during pregnancy were at increased risk of hypertensive disorders in pregnancy, early pregnancy loss, preterm delivery and having children small for gestational age. The validity of Danish national registers was acceptable for identification of SARS‐CoV‐2 infection during pregnancy.
20 February 2025 in American Journal of Obstetrics and Gynecology
Recently, the International Papillomavirus Society (IPVS) convened a working group on cervical HPV latency, which resulted in an updated understanding of the HPV natural history. While the previous HPV natural history model considered HPV detection a result of HPV acquisition or possibly re-infection, and loss of HPV detection a result of viral clearance, the updated understanding of the HPV natural history is more nuanced. Thus, HPV detection may occur as a result of autoinoculation, deposition from a recent sex act, or as a redetection of a previously acquired infection. Similarly, loss of HPV detection likely reflects immune control rather than complete viral clearance. As it is practically impossible to identify the "true" source of a new HPV detection or determine why HPV is no longer detectable, we propose that health care providers and researchers use the terminology HPV detected vs HPV not detected. Moreover, we describe the updated understanding in a clinical context. Specifically, we discuss the potential implications of the updated understanding on clinical counseling in screening, and recommendations on cervical screening and HPV vaccination. We also suggest key phrases health care providers may use when counseling women attending routine HPV-based cervical screening.
The incidence and mortality of cervical cancer are high in Danish women aged 60 years and older who are about to exit the cervical cancer screening program. The present study aimed to describe the screening history in women ≥60 years old, diagnosed with cervical cancer in Denmark, 2009‐2013. We retrieved information on cases of cervical cancer and previous cervical cancer screening from national registries. During the study period, a total of 1907 women were diagnosed with cervical cancer, 574 (30.1%) of which were ≥60 years old. The majority of women were diagnosed with squamous cell carcinoma (73.7%) and advanced‐stage disease (ASD, ie, ≥FIGO IIB; 63.1%). The proportion of ASD increased with age, from 51.9% in women aged 60‐64% to 76.7% in women aged 75‐79. Among screened women (n = 377), 22.8% had a cervical cytology within 5 years of diagnosis, 73.3% of which were normal, and 45.1% were diagnosed with ASD. Women who had been sufficiently screened prior to screening exit (≥2 normal cytology test in the age interval 50‐59) accounted for 18.1%. Of note, 53.8% of the sufficiently screened women were diagnosed with ASD. Sufficiently screened women were less likely to be diagnosed with ASD compared to never‐screened women (53.8% vs 67.5%, P < 0.020), but no difference was observed between sufficiently and insufficiently screened women (53.8% vs 63.4%, P = 0.091). Our findings suggest that cancer in older women may occur due to insufficient screening prior to screening exit, a low sensitivity of screening, and premature screening exit.