Time trends in human papillomavirus prevalence and genotype distribution in vulvar carcinoma in Norway.

INTRODUCTION: Approximately 25%-43% of all vulvar carcinomas are associated with human papillomavirus (HPV). In many countries, vulvar carcinoma incidence rates are increasing, possibly due to greater HPV exposure. However, studies exploring changes in HPV prevalence and genotype distribution in vulvar carcinoma over time are scarce. Our aim was to evaluate time trends in HPV prevalence and genotype distribution in vulvar squamous cell carcinoma in an unselected, nationwide sample of Norwegian women. Further, we explored clinical and histopathological aspects in relation to HPV status and investigated whether HPV status was associated with survival. MATERIAL AND METHODS: All vulvar squamous cell carcinoma cases from 1970-1975 and 2000-2005 were extracted from the Cancer Registry of Norway and corresponding tissue blocks were retrieved. After detailed histology review, HPV testing was conducted using real-time TaqMan PCR. Overall survival rates were calculated using the Kaplan-Meier method. Multivariable Cox regression analysis was performed to estimate hazard ratios adjusted for age at diagnosis, stage and diagnostic period. RESULTS: Histological review was performed on 352 vulvar squamous cell carcinoma cases. We were able to obtain valid HPV analysis results for 282 cases, Overall, 29.8% (95% CI 24.5%-35.5%) of cases were high-risk HPV (hrHPV)-positive. When comparing the two periods, we found that the percentage of hrHPV-positive tumors increased significantly from 23% (95% CI 16.0%-31.4%) in 1970-1975 to 35.3% (95% CI 27.8%-43.3%) in 2000-2005 (P = 0.025). The predominant genotypes were HPV 16 (73%), HPV 33 (21%), and HPV 18 (6%), with similar distributions in both periods. In the more recent cohort, several additional genotypes were detected: HPV 6, 11, 39, 45, 52, 58 and 66 were found in smaller percentages, ranging from 1.8% to 3.6%. In univariate analysis, patients with HPV-positive tumors showed improved overall survival compared with patients with HPV-negative tumors (hazard ratio [HR] 0.65, 95% CI 0.48-0.86). CONCLUSIONS: The prevalence of HPV in vulvar squamous cell carcinomas in Norway was significantly higher in 2000-2005 than in 1970-1975. The three predominant genotypes were HPV 16, 33 and 18 in both time periods. However, several other HPV genotypes have emerged over the last decades. HPV-positivity was associated with better overall survival.

Evidence for investing in parenting interventions aiming to improve child health: a systematic review of economic evaluations.

A comprehensive review of the economic evidence on parenting interventions targeting different aspects of child health is lacking to support decision-making. The aim of this review is to provide an up to date synthesis of the available health economic evidence for parenting interventions aiming to improve child health. A systematic review was conducted with articles identified through Econlit, Medline, PsychINFO, and ERIC databases. Only full economic evaluations comparing two or more options, considering both costs and outcomes were included. We assessed the quality of the studies using the Drummond checklist. We identified 44 studies of varying quality that met inclusion criteria; 22 targeting externalizing behaviors, five targeting internalizing problems, and five targeting other mental health problems including autism and alcohol abuse. The remaining studies targeted child abuse (n = 5), obesity (n = 3), and general health (n = 4). Studies varied considerably and many suffered from methodological limitations, such as limited costing perspectives, challenges with outcome measurement and short-time horizons. Parenting interventions showed good value for money in particular for preventing child externalizing and internalizing behaviors. For the prevention of child abuse, some programs had the potential of being cost-saving over the longer-term. Interventions were not cost-effective for the treatment of autism and obesity. Future research should include a broader spectrum of societal costs and quality-of-life impacts on both children and their caregivers.

Cytokine and Gene Expression Profiling in Patients with HFE-Associated Hereditary Hemochromatosis according to Genetic Profile.

BACKGROUND: Hemochromatosis gene (HFE)-associated hereditary hemochromatosis (HH) is characterized by downregulation of hepcidin synthesis, leading to increased intestinal iron absorption. OBJECTIVES: The objectives were to characterize and elucidate a possible association between gene expression profile, hepcidin levels, disease severity, and markers of inflammation in HFE-associated HH patients. METHODS: Thirty-nine HFE-associated HH patients were recruited and assigned to 2 groups according to genetic profile: C282Y homozygotes in 1 group and patients with H63D, as homozygote or in combination with C282Y, in the other group. Eleven healthy first-time blood donors were recruited as controls. Gene expression was characterized from peripheral blood cells, and inflammatory cytokines and hepcidin-25 isoform were quantified in serum. Biochemical disease characteristics were recorded. RESULTS: Elevated levels of interleukin 8 were observed in a significant higher proportion of patients than controls. In addition, compared to controls, gene expression of ζ-globin was significantly increased among C282Y homozygote patients, while gene expression of matrix metalloproteinase 8, and other neutrophil-secreted proteins, was significantly upregulated in patients with H63D. CONCLUSION: Different disease signatures may characterize HH patients according to their HFE genetic profile. Studies on larger populations, including analyses at protein level, are necessary to confirm these findings.

The cost-effectiveness of a culturally tailored parenting program: estimating the value of multiple outcomes.

BACKGROUND: Parenting programs can be economically attractive interventions for improving the mental health of both parents and their children. Few attempts have been made to analyse the value of children's and parent's outcomes simultaneously, to provide a qualified support for decision making. METHODS: A within trial cost-effectiveness evaluation was conducted, comparing Ladnaan, a culturally tailored parenting program for Somali-born parents, with a waitlist control. Quality-adjusted life years (QALY) for parents were estimated by mapping the General Health Questionnaire-12 to Euroqol's EQ-5D-3L to retrieve utilities. Behavioural problems in children were measured using the Child Behaviour Checklist (CBCL). Intervention costs were estimated for the trial. A net benefit regression framework was employed to study the cost-effectiveness of the intervention, dealing with multiple effects in the same analysis to estimate different combinations of willingness-to pay (WTP) thresholds. RESULTS: For a WTP of roughly €300 for a one point improvement in total problems on the CBCL scale (children), Ladnaan is cost-effective. In contrast, the WTP would have to be roughly €580,000 per QALY (parents) for it to be cost-effective. Various combinations of WTP values for the two outcomes (i.e., CBCL and QALY) may be used to describe other scenarios where Ladnaan is cost-effective. CONCLUSIONS: Decision-makers interested in multiple effects must take into account combinations of effects in relation to budget, in order to obtain cost-effective results. A culturally adapted parenting program may be cost-effective, depending on the primary outcome, or multiple outcomes of interest. Trial registration clinicaltrials.gov, NCT02114593. Registered 15 April 2014-prospectively registered, https://www.clinicaltrials.gov/ct2/results?recrs=&cond=&term=NCT02114593&cntry=&state=&city=&dist=.

Adding the Coping Power Programme to parent management training: the cost-effectiveness of stacking interventions for children with disruptive behaviour disorders.

Parent management training (PMT) programmes and child cognitive behavioural therapy are recommended approaches for treatment of oppositional defiant disorder in children, and combining these may be effective. However, little is known regarding the economic efficiency of this additive effect. A within-trial cost-effectiveness analysis was carried out in Sweden including 120 children aged 8-12 who screened positive for disruptive behaviour disorders, within a psychiatric care setting, and their parents. They were randomly assigned to either the Swedish group-based PMT Comet, or to an enhanced version, where an additional child component was provided, the Coping Power Programme (CPP). Child behaviour problems as well as healthcare and educational resource use were measured at baseline, post-test and at two-year follow-up. A net benefit regression framework was used to estimate differences in costs and health outcomes between the two intervention arms during the two-year period. Comet with CPP cost on average 820 EURO more per family than Comet only. At the 2-year follow-up, there were 37% recovered cases of ODD in Comet with CPP, in comparison to 26% in the Comet only arm. At a willingness-to-pay of approximately 62,300 EURO per recovered case of ODD, Comet with CPP yielded positive net benefits, in comparison to Comet only. Offering children the CPP simultaneously as their parents receive PMT, in comparison to only providing PMT, yields clinically relevant gains. Despite the relatively small cost for CPP, investment in combining PMT and CPP should be guided by resource prioritisation. Trial registration number: ISRCTN10834473, date of registration: 23/12/2015.

Economic Evaluations of Public Health Interventions to Improve Mental Health and Prevent Suicidal Thoughts and Behaviours: A Systematic Literature Review.

To review the literature on economic evaluations of public health interventions targeting prevention of mental health problems and suicide, to support evidence based societal resource allocation. A systematic review of economic evaluations within mental health and suicide prevention was conducted including studies published between January 2000 and November 2018. The studies were identified through Medline, PsychINFO, Web of Science, the National Health Service Economic Evaluation Database and Health Technology Assessment. The quality of relevant studies and the transferability of their results were assessed using a criterion set out by the Swedish Agency for Health Technology Assessment. Nineteen studies of moderate to high quality were included in this review, which evaluated 18 interventions in mental health and four interventions in suicide prevention. Fourteen (63%) of all interventions were cost-effective based on the conclusions from original papers. None of the studies that evaluated suicide prevention was of high quality. The interventions largely focused on psychological interventions at school, the workplace and within elderly care as well as screening and brief interventions in primary care. Nine studies (around 50% of included articles) had a high potential for transferability to the Swedish context. Public health interventions aiming to improve mental health have a high potential to be economically beneficial to society, but high-quality evidence on the cost-effectiveness of suicide prevention is limited.

Economic evaluations of public health interventions for physical activity and healthy diet: A systematic review.

Physical inactivity and unhealthy dietary habits are associated with an increased disease and economic burden. The aim of this systematic review was to identify economic evaluations of public health interventions targeting physical activity and healthy diet, and assess the quality and transferability of the findings to the Swedish context. A search of published economic evaluations was conducted through electronic databases including PubMed, Web of Science, PsycINFO, National Health Service Economic Evaluation Databases (NHS EED) and the Health Technology Assessment Database (HTA). An additional search was done using references of relevant systematic reviews and websites of relevant organizations were checked to find grey literature. Quality and transferability of the economic evaluations were appraised using a quality assessment tool developed by the Swedish Agency for Health Technology Assessment. Thirty-two economic evaluations, rated as moderate or high quality, of 178 interventions were included; thirteen studies targeting physical activity, thirteen targeting healthy diet and six targeting both. The interventions varied in terms of their content, setting, mode of delivery and target populations. A majority of the economic evaluations reported that the interventions were likely to be cost-effective; however, considerable variations in the methodological and reporting qualities were observed. Only half of the economic evaluations were rated to have a high probability of transferring to the Swedish context. Public health interventions targeting physical activity and dietary habits have a high potential to be cost-effective. However, decision makers should consider the variation in quality and transferability of the available evidence.

Circulating microRNAs in patients with immune thrombocytopenia before and after treatment with thrombopoietin-receptor agonists.

MicroRNAs (miRNAs) are small non-coding RNAs involved in the regulation of gene expression. Dysregulated expression of several miRNAs has been found in primary immune thrombocytopenia (ITP) suggesting that miRNAs are likely involved in the pathogenesis of ITP. We aimed to explore the differential expression of miRNAs in patients with ITP before and after starting treatment with thrombopoietin-receptor agonists (TPO-RAs) to clarify their roles in the pathophysiology of ITP, and as potential diagnostic and prognostic markers of this disorder.We performed a profiling study where 179 miRNAs were analyzed in eight ITP patients before and during treatment with TPO-RAs and in eight controls using miRNA PCR panel; 81 miRNAs were differentially expressed in ITP patients compared to controls, and 14 miRNAs showed significant changes during TPO-RA-treatment. Ten miRNAs were selected for validation that was performed in 23 patients and 22 controls using droplet digital PCR. Three miRNAs were found to be differentially expressed in ITP patients before TPO-RA-treatment compared to controls: miR-199a-5p was down-regulated (p = 0.0001), miR-33a-5p (p = 0.0002) and miR-195-5p (p = 0.035) were up-regulated. Treatment with TPO-RAs resulted in changes in six miRNAs including miR-199a-5p (p = 0.001), miR-33a-5p (p = 0.003), miR-382-5p (p = 0.004), miR-92b-3p (p = 0.005), miR-26a-5p (p = 0.008) and miR-221-3p (p = 0.023); while miR-195-5p remained unchanged and significantly higher than in controls, despite the increase in the platelet count, which may indicate its possible role in the pathophysiology of ITP. Regression analysis revealed that pre-treatment levels of miR-199a-5p and miR-221-3p could help to predict platelet response to TPO-RA-treatment. ROC curve analysis showed that the combination of miR-199a-5p and miR-33a-5p could distinguish patients with ITP from controls with AUC of 0.93.This study identifies a number of differentially expressed miRNAs in ITP patients before and after initiation of TPO-RAs with potential roles in the pathophysiology, as well as with a possible utility as diagnostic and prognostic biomarkers. These interesting findings deserve further exploration and validation in future studies.

Economic Return on Investment of Parent Training Programmes for the Prevention of Child Externalising Behaviour Problems.

Economic models to inform decision-making are gaining popularity, especially for preventive interventions. However, there are few estimates of the long-term returns to parenting interventions used to prevent mental health problems in children. Using data from a randomised controlled trial evaluating five indicated parenting interventions for parents of children aged 5-12, we modeled the economic returns resulting from reduced costs in the health care and education sector, and increased long-term productivity in a Swedish setting. Analyses done on the original trial population, and on various sized local community populations indicated positive benefit-cost ratios. Even smaller local authorities would financially break-even, thus interventions were of good value-for-money. Benefit-cost analyses of such interventions may improve the basis for resource allocation within local decision-making.

Indicated preventive interventions for depression in children and adolescents: A meta-analysis and meta-regression.

Depression contributes about 2% to the global burden of disease. A first onset of depressive disorder or subsyndromal depressive symptoms is common in adolescence, indicating that early prevention is a priority. However, trials of preventive interventions for depression in youths show conflicting results. This systematic review and meta-analysis investigated the effectiveness of group-based cognitive behavioral therapy (GB-CBT) as a preventive intervention targeting subsyndromal depression in children and adolescents. In addition, the impact of different covariates (type of comparator and use of booster sessions) was assessed. Relevant articles were identified from previous systematic reviews, and supplemented with an electronic search spanning from 01/09/2014 to 28/02/2018. The retrieved articles were assessed for eligibility and risk of bias. Relevant data were extracted. Intervention effectiveness was pooled using a random-effects model and the impact of covariates assessed using meta-regression. 38 eligible articles (34 trials) were obtained. The analysis showed GB-CBT to significantly reduce the incidence (relative risk 0.43, 95% CI 0.21-0.87) and symptoms (Cohen's d -0.22, 95% CI -0.32 to -0.11) of depression at post-test compared to all controls. Comparisons with passive comparators suggested that the effect decayed over time. However, compared to active controls, a significant intervention effect was evident only after 12 month or more. Our results suggest that the preventive effect of GB-CBT wears off, but still lasts longer than the effect of active comparators. Only a few studies included booster sessions, precluding firm conclusions. Future studies should clarify to what extent maintenance strategies can prolong the preventive effect of GB-CBT.

Quality of life and service use amongst parents of young children: Results from the Children and Parents in Focus trial.

Aim: The aim of this study was to assess the quality of life (QoL) and service use of parents who have preschool-aged children, and whether the mental-health problems of parents and their children predict these outcomes. Methods: Cross-sectional data were gathered in 2015-2016 in Uppsala County in Sweden where 3164 parents of children aged three- to five-years-old were asked to self-report their own and their children's mental-health status and service use in the past 12 months. Data from the General Health Questionnaire were used to derive health-related quality of life (HRQoL) measures for adults. Results: Very few parents reported mental-health problems, while approximately 15% of the sample used any type of parental support and/or psychological health-care service. Families without problems used the least amount of resources. Parents' own mental-health problems predicted usage of both psychotherapy and couples' therapy, while child problems predicted the former but also the use of a parenting program. Parental HRQoL was predicted by mental-health problems, and all families with at least one individual experiencing problems rated their QoL lower than families without problems. Conclusions: Parental service use and HRQoL is associated not only with their own mental-health status but also with their children's mental-health problems.

Health, public sector service use and related costs of Swedish preschool children: results from the Children and Parents in Focus trial.

Despite Sweden's good child health statistics, data on the mental health and wellbeing of Swedish preschool children is scarce and not routinely collected in healthcare. The study aimed to: identify the proportion of preschool children with mental health and somatic problems, the public sector services used by these children and whether they differ by type of problems, investigate whether other factors affect service use, and estimate the costs associated with these services. This study used cross-sectional data on a sample of 3175 children aged 3-5 from the "Children and Parents in Focus trial". Data on service use, child health and demographics were obtained from primary caregivers. Child mental health was assessed by both primary caregivers and teachers. 8.9% of the sample reported mental health problems, and approximately 1% had comorbid somatic and mental health problems. Over 50% of the preschoolers used any service, with school assistant being the most frequently used. The average annual cost per child, regardless of health status, was US$921, with 75% of the costs accruing at school. The presence of both somatic and mental health problems predicted higher service use, in particular extra services used at school and at home (mean annual cost US$13826 and US$1583, respectively). Children with comorbid problems accounted for the highest mean costs. Mental health problems among preschool children were particularly high compared to studies from other countries. There is a need to strengthen school mental health services to engage in proactive early identification of children with mental health problems so that appropriate care is provided.Trial registration number: ISRCTN16513449. Registered 23 July 2013.

Placental human papillomavirus infections and adverse pregnancy outcomes.

INTRODUCTION: Knowledge on prevalence and association of human papillomavirus (HPV) in third trimester placentae and adverse pregnancy outcomes is limited. We investigated the prevalence of placental HPV at delivery, explored urine HPV characteristics associated with placental HPV and whether placental HPV increased the risk adverse pregnancy outcomes. METHODS: Pregnant women were enrolled in the Scandinavian PreventADALL mother-child cohort study at midgestation. Human papillomavirus genotyping was performed on placental biopsies collected at delivery (n = 587) and first-void urine at midgestation and delivery (n = 556). Maternal characteristics were collected by questionnaires at gestational week 18 and 34. Adverse pregnancy outcomes were registered from chart data including hypertensive disorders of pregnancy, gestational diabetes mellitus and newborns small for gestational age. Uni- and multivariable regression models were used to investigate associations. RESULTS: Placental HPV was detected in 18/587 (3 %). Twenty-eight genotypes were identified among the 214/556 (38 %) with midgestational urine HPV. Seventeen of the 18 women with placental HPV were midgestational HPV positive with 89 % genotype concordance. Midgestational high-risk-(HR)-HPV and high viral loads of Any- or HR-HPV were associated with placental HPV. Persisting HPV infection from midgestation to delivery was not associated with placental HPV. Adverse pregnancy outcomes were seen in 2/556 (0.4 %) of women with placental HPV. DISCUSSION: In this general cohort of pregnant women, the prevalence of placental HPV was 3 %, and midgestational urinary HPV 38 %. High HPV viral load increased the risk for placental HPV infections. We observed no increased risk for adverse pregnancy outcomes in women with placental HPV.

A model for evaluating the economic value of prevention programs for illicit use of anabolic androgenic steroids.

BACKGROUND: The illicit use of anabolic androgenic steroids (AAS) has become a societal concern. We developed a decision-analytic model for assessing the cost-effectiveness of preventive interventions targeting AAS-use. We used scenario analyses to demonstrate: a) the potential health economic consequences of AAS use in Sweden, and b) the cost-effectiveness of a hypothetical preventive intervention. METHODS: A population-based cohort model compared a hypothetical preventive intervention targeting AAS with a 'no intervention' scenario, from a limited societal perspective. The model simulated how a cohort of 18 year-old males transitioned between different states and predicted their health status and complications until the age of 41. Health outcomes were estimated as quality-adjusted life-years (QALY). Costs included intervention costs, drug costs, and costs of complications. RESULTS: Total yearly costs related to AAS use amounted to nearly half a million US$, with the largest cost borne by the healthcare sector. Results suggest that AAS prevention could entail large costs and benefits with a mean incremental cost-effectiveness ratio of $550 per QALY, in a scenario where the intervention would decrease the probability of initiating AAS use by 5%. CONCLUSION: Results show large AAS related costs, and suggest that the implementation of a preventive intervention could offer good value for money given different effectiveness scenarios. This model can be used to estimate the value of interventions targeting AAS use.

A systematic review of economic evaluations of public health interventions targeting alcohol, tobacco, illicit drug use and problematic gambling: Using a case study to assess transferability.

AIMS: To identify and assess the cost-effectiveness of public health interventions targeting the use of alcohol, illicit drugs and tobacco, as well as problematic gambling behavior (ANDTS), and consider whether the results from these evaluations are transferable to the Swedish setting. METHODS: A systematic review of economic evaluations within the area of ANDTS was conducted including studies published between January 2000 and November 2018, identified through Medline, PsychINFO, Web of Science, the National Health Service Economic Evaluation Database and Health Technology Assessment. The quality of relevant studies and the possibilities of transferring results were assessed using criteria set out by the Swedish Agency for Health Technology Assessment. RESULTS: Out of 54 relevant studies, 39 were of moderate to high quality and included in the review, however none for problematic gambling. Eighty-one out of a total of 91 interventions were cost-effective. The interventions largely focusing on taxed-based policies or screening and brief interventions. Thirteen of these studies were deemed to have high potential for transferability, with effect estimates considered relevant, and with good feasibility for implementation in Sweden. CONCLUSIONS: Interventions targeting alcohol- and illicit-drug use and tobacco use are cost-effective approaches, and results may be transferred to the Swedish setting. Caution must be taken regarding cost estimates and the quality of the evidence which the studies are based upon.

Maternal human papillomavirus infections at mid-pregnancy and delivery in a Scandinavian mother-child cohort study.

OBJECTIVES: Human papillomavirus (HPV) infections are common, especially during women's reproductive years, with unclear obstetrical impact. This study aimed to identify HPV prevalence at mid-gestation and delivery, type-specific persistence from mid-gestation to delivery, and risk factors for HPV infection and persistence. METHODS: In 757 women from a Scandinavian prospective mother-child cohort, HPV was analyzed in first-void urine samples at mid-gestation and delivery. We used Seegene Anyplex II HPV28 PCR assay for genotyping and semi-quantifying 28 genital HPV genotypes, including 12 high-risk HPVs (HR-HPV). Socio-demographic and health data were collected through e-questionnaires. RESULTS: Any-HPV genotype (any of 28 assessed) was detected in 38% of the study cohort at mid-gestation and 28% at delivery, and HR-HPVs in 24% and 16%, respectively. The most prevalent genotype was HPV16: 6% at mid-gestation and 4% at delivery. Persistence of Any-HPV genotype was 52%, as was HR-HPV genotype-specific persistence. A short pre-conception relationship with the child's father and alcohol intake during pregnancy increased HPV infection risk at both time points. Low viral load at mid-gestation was associated with clearance of HPV infections at delivery. CONCLUSION: HPV prevalence was higher at mid-gestation compared with delivery, and low viral load was associated with clearance of HPV at delivery.

Cost-effectiveness analysis of parenting interventions for the prevention of behaviour problems in children.

BACKGROUND: Behavior problems are common among children and place a high disease and financial burden on individuals and society. Parenting interventions are commonly used to prevent such problems, but little is known about their possible longer-term economic benefits. This study modelled the longer-term cost-effectiveness of five parenting interventions delivered in a Swedish context: Comet, Connect, the Incredible Years (IY), COPE, bibliotherapy, and a waitlist control, for the prevention of persistent behavior problems. METHODS: A decision analytic model was developed and used to forecast the cost per averted disability-adjusted life-year (DALY) by each parenting intervention and the waitlist control, for children aged 5-12 years. Age-specific cohorts were modelled until the age of 18. Educational and health care sector costs related to behavior problems were included. Active interventions were compared to the waitlist control as well as to each other. RESULTS: Intervention costs ranged between US$ 14 (bibliotherapy) to US$ 1,300 (IY) per child, with effects of up to 0.23 averted DALYs per child (IY). All parenting interventions were cost-effective at a threshold of US$ 15,000 per DALY in relation to the waitlist control. COPE and bibliotherapy strongly dominated the other options, and an additional US$ 2,629 would have to be invested in COPE to avert one extra DALY, in comparison to bibliotherapy. CONCLUSIONS: Parenting interventions are cost-effective in the longer run in comparison to a waitlist control. Bibliotherapy or COPE are the most efficient options when comparing interventions to one another. Optimal decision for investment should to be based on budget considerations and priority settings.

Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions.

BACKGROUND: Comparative data on different self-collection methods is limited. OBJECTIVES: To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions. STUDY DESIGN: Three hundred ten patients collected two cervicovaginal specimens using a brush (Evalyn®Brush) and a swab (FLOQSwabs™), and filled a questionnaire at home. Then, a physician at the clinic took a cervical specimen into PreservCyt® buffer for hrHPV testing and cytology. All specimens were tested using Anyplex™ II HPV28, Cobas® 4800 HPV Test and Xpert®HPV. RESULTS: Performance comparison included 45 cervical carcinomas and 187 patients with premalignant lesions. Compared to the physician-specimen, hrHPV testing of Evalyn®Brush showed non-inferior sensitivity for CIN3+ (relative sensitivity of Anyplex™ 0.99; Cobas® 0.96; Xpert®HPV 0.97) while hrHPV testing of FLOQSwabs™ showed inferior sensitivity (relative sensitivity of Anyplex™ 0.91; Cobas® 0.92; Xpert®HPV 0.93). Similar results were observed for invasive carcinomas albeit that FLOQSwabs™ was statistically non-inferior to the physician-specimen. Self-collection by either Evalyn®Brush or FLOQSwabs™ was more sensitive for CIN3+ than LSIL or worse cytology. Significant decrease in sensitivity for CIN3+ were observed for FLOQSwabs™ when specimens were preprocessed for hrHPV testing after 28 days. Both devices were well accepted, but patients considered Evalyn®Brush easier and more comfortable than FLOQSwabs™. CONCLUSIONS: Self-collection is comparable to current screening practice for detecting cervical carcinoma and CIN3+ but device and specimen processing effects exist. Only validated procedure including collection device, hrHPV assay and specimen preparation should be used.