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- Villa, Luisa L., et al.
(author)
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Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
- 2007
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In: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 356:19, s. 1915-1927
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Journal article (peer-reviewed)abstract
- BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group.
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| 3. |
- Villa, L., et al.
(author)
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Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials
- 2007
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In: The Lancet. - 1474-547X. ; 369:9576, s. 1861-1868
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Journal article (peer-reviewed)abstract
- Background Cervical cancer and its obligate precursors, cervical intraepithelial neoplasia grades 2 and 3 (CIN2/3), and adenocarcinona in situ (AIS), are caused by oncogenic human papillomavirus (HPV). In this combined analysis of four clinical trials we assessed the effect of prophylactic HPV vaccination on these diseases. Methods 20 583 women aged 16-26 years were randomised to receive quadrivalent HPV6/11/16/18 vaccine (n=9087), its HPV16 vaccine component (n=1204), or placebo (n=10292). They underwent periodic Papanicolaou testing, with colposcopy or biopsy for detected abnormalities. The primary composite endpoint was the combined incidence of HPV16/18-related CIN2/3, AIS, or cervical cancer. These trials are registered at ClinicalTrials.gov, numbers NCT00365378, NCT00365716, NCT00092521, and NCT00092534. Findings Mean follow-up was 3.0 years (SD 0.66) after first dose. In women negative for HPV16 or HPV18 infection during the vaccination regimen (n=17129, per protocol), vaccine efficacy was 99% for the primary endpoint (95% Cl 93-100), meeting the statistical criterion for success. In an intention-to-treat analysis of all randomised women (including those who were HPV16/18 naive or HPV16/18-infected at day 1), efficacy was 44% (95% Cl 31-55); all but one case in vaccine recipients occurred in women infected with HPV16 or HPV18 before vaccination. In a second intention-to-treat analysis we noted an 18% reduction (95% CI 7-29) in the overall rate of CIN2/3 or AIS due to any HPV type. Interpretation Administration of HPV vaccine to HPV-naive women, and women who are already sexually active, could substantially reduce the incidence of HPV16/18-related cervical precancers and cervical cancer.
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- Thoresen, L., et al.
(author)
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The association of nutritional assessment criteria with health-related quality of life in patients with advanced colorectal carcinoma
- 2012
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In: European Journal of Cancer Care. - : Blackwell Publishing. - 0961-5423 .- 1365-2354. ; 21:4, s. 505-516
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Journal article (peer-reviewed)abstract
- Health-related quality of life (QoL) is a goal in nutritional oncology but the association between nutritional status and QoL is rarely explored. The aim of the study was to investigate the association of nutritional assessment criteria with QoL in 50 patients with advanced colorectal carcinoma. A second aim was to investigate changes in body weight and QoL during a 3-month follow-up. Muscle mass, nutritional risk, malnutrition and cachexia according to three different criteria were assessed, as well as health-related QoL. At inclusion, 36 patients experienced weight loss, 10 patients sarcopenia, 25 were at nutritional risk, 16 were malnourished and 11, 14 and 31 patients had cachexia according to different criteria. All nutritional assessment criteria discriminated between groups of patients with worse or better QoL to varying degrees. Malnutrition and cachexia defined by the European Palliative Care Research Collaborative and adjusted for recent gain or stabilisation of body weight discriminated on most QoL scores. Weight loss at follow-up was associated with a decrease in several QoL scores. Recognition of weight loss as well as diagnosing malnutrition and cachexia should be the first steps in an interventional pathway to enhance nutritional status and QoL in patients with advanced colorectal carcinoma.
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- Haatveit, Beathe, et al.
(author)
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Reduced load-dependent default mode network deactivation across executive tasks in schizophrenia spectrum disorders
- 2016
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In: NeuroImage. - 0353-8842 .- 2213-1582. ; 12, s. 389-396
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Journal article (peer-reviewed)abstract
- BACKGROUND: Schizophrenia is associated with cognitive impairment and brain network dysconnectivity. Recent efforts have explored brain circuits underlying cognitive dysfunction in schizophrenia and documented altered activation of large-scale brain networks, including the task-positive network (TPN) and the task-negative default mode network (DMN) in response to cognitive demands. However, to what extent TPN and DMN dysfunction reflect overlapping mechanisms and are dependent on cognitive state remain to be determined.METHODS: In the current study, we investigated the recruitment of TPN and DMN using independent component analysis in patients with schizophrenia spectrum disorders (n = 29) and healthy controls (n = 21) during two different executive tasks probing planning/problem-solving and spatial working memory.RESULTS: We found reduced load-dependent DMN deactivation across tasks in patients compared to controls. Furthermore, we observed only moderate associations between the TPN and DMN activation across groups, implying that the two networks reflect partly independent mechanisms. Additionally, whereas TPN activation was associated with task performance in both tasks, no such associations were found for DMN.CONCLUSION: These results support a general load-dependent DMN dysfunction in schizophrenia spectrum disorder across two demanding executive tasks that is not merely an epiphenomenon of cognitive dysfunction.
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| 15. |
- Haatveit, Beathe, et al.
(author)
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Reduced load-dependent default mode network deactivation across executive tasks in schizophrenia spectrum disorders
- 2016
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In: NeuroImage Clinical. - : Elsevier BV. - 0353-8842 .- 2213-1582. ; 12, s. 389-396
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Journal article (peer-reviewed)abstract
- BACKGROUND: Schizophrenia is associated with cognitive impairment and brain network dysconnectivity. Recent efforts have explored brain circuits underlying cognitive dysfunction in schizophrenia and documented altered activation of large-scale brain networks, including the task-positive network (TPN) and the task-negative default mode network (DMN) in response to cognitive demands. However, to what extent TPN and DMN dysfunction reflect overlapping mechanisms and are dependent on cognitive state remain to be determined. METHODS: In the current study, we investigated the recruitment of TPN and DMN using independent component analysis in patients with schizophrenia spectrum disorders (n = 29) and healthy controls (n = 21) during two different executive tasks probing planning/problem-solving and spatial working memory. RESULTS: We found reduced load-dependent DMN deactivation across tasks in patients compared to controls. Furthermore, we observed only moderate associations between the TPN and DMN activation across groups, implying that the two networks reflect partly independent mechanisms. Additionally, whereas TPN activation was associated with task performance in both tasks, no such associations were found for DMN. CONCLUSION: These results support a general load-dependent DMN dysfunction in schizophrenia spectrum disorder across two demanding executive tasks that is not merely an epiphenomenon of cognitive dysfunction.
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- Hansson, B. A. M., et al.
(author)
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Characterisation of a liquid-xenon jet laser-plasma extreme-ultraviolet source
- 2004
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In: Review of Scientific Instruments. - : AIP Publishing. - 0034-6748 .- 1089-7623. ; 75:6, s. 2122-2129
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Journal article (peer-reviewed)abstract
- A liquid-xenon-jet laser-plasma source for extreme-ultraviolet (EUV) and soft-x-ray generation has been characterized. Being a source candidate for EUV lithography (EUVL), we especially focus on parameters important for the integration of the source in EUVL systems. The deep-ultraviolet (DUV) out-of-band radiation (=120–400 nm) was quantified, to within a factor of two, using a flying-circus tool together with a transmission-grating spectrograph resulting in a total DUV conversion efficiency (CE) of ~0.33%/2sr. The size and the shape of the xenon plasma was investigated using an in-band-only EUV microscope, based on a spherical Mo/Si multilayer mirror and a charge-coupled device detector. Scalability of the source size from 20–270 µm full width at half maximum was shown. The maximum repetition-rate sustainable by the liquid-xenon-jet target was simulated by a double-pulse experiment indicating feasibility of >17 kHz operation. The xenon-ion energy distribution from the plasma was determined in a time-of-flight experiment with a Faraday-cup detector showing the presence of multi-kilo-electron-volt ions. Sputtering of silicon witness plates exposed to the plasma was observed, while a xenon background of >1 mbar was shown to eliminate the sputtering. It is concluded that the source has potential to meet the requirements of future EUVL systems.
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| 18. |
- Hofvind, S., et al.
(author)
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Influence of review design on percentages of missed interval breast cancers : Retrospective study of interval cancers in a population-based screening program
- 2005
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In: Radiology. - : Radiological Society of North America (RSNA). - 0033-8419 .- 1527-1315. ; 237:2, s. 437-443
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Journal article (peer-reviewed)abstract
- PURPOSE: To retrospectively investigate whether different review designs have an influence on the estimate of missed interval cancer in a population-based breast cancer screening program. MATERIALS AND METHODS: The Norwegian Breast Cancer Screening Program invites women aged 50-69 years to undergo biennial screening mammography. The current study was part of the evaluation and scientific aspects of the screening program and thus was covered by the general ethical approval of the screening program as a part of the Cancer Registry of Norway. All participants signed an informed consent that specified that data related to their screening visit could be used for evaluation and scientific purposes. Six radiologists (9-34 years of experience in mammography) reviewed previously obtained bilateral two-view screening and diagnostic mammograms of 231 interval cancers, 117 screening-detected cancers, and 373 normal cases. Four review designs were used: individual and paired blinded review and individual and consensus informed review. A five-point interpretation scale was used to reclassify the cancers into missed cancers, minimal signs, and true cancers. The number and proportion of subgroups were estimated with 95% confidence intervals. RESULTS: Of 231 interval cancers, 46 (19.9%) were reclassified as missed cancers with the mixed blinded individual review and 54 (23.4%) were classified as missed cancers with the mixed blinded paired review. Eighty-three cancers (35.9%) were classified as missed cancers with individual informed review, and 78 (33.8%) were classified as missed cancers with consensus informed review. Thirty-nine cancers (16.8%) were reclassified as missed when four or more radiologists assigned a score of 2 or more (probably benign or more suspicious), three cancers (1.3%) were reclassified as missed when a score of 4 or more (probably malignant or more suspicious) was assigned. CONCLUSION: The percentage of interval cancers classified as missed ranged from 1.3% to 35.9% according to review design. To encourage learning, a review protocol should include both blinded and informed designs. © RSNA, 2005.
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| 20. |
- Thoresen, L, et al.
(author)
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Doctors and nurses on wards with greater access to clinical dietitians have better focus on clinical nutrition.
- 2008
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In: Journal of human nutrition and dietetics : the official journal of the British Dietetic Association. - 1365-277X. ; 21:3, s. 239-47
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Journal article (peer-reviewed)abstract
- BACKGROUND: According to the Council of Europe, clinical dietitians should assume a more central role in nutritional support. The aim of this study was to assess the opinions among doctors, nurses and clinical dietitians regarding the use of clinical dietitians' expertise in the hospital units and, further, to assess whether the presence of clinical dietitians in hospital departments influenced doctors and nurses focus on clinical nutrition. METHODS: A questionnaire about the use of clinical nutrition was mailed to 6000 doctors and 6000 nurses working in hospital units where undernutrition is documented to be common, as well as to 678 clinical dietitians working in Scandinavian hospitals. RESULTS: The response rate of clinical dietitians, nurses and doctors were 53%, 46% and 29%, respectively. Nurses and doctors who saw clinical dietitians often found it less difficult to identify undernourished patients and found that insight into the importance of adequate nutrition was better than those who saw clinical dietitians seldom. Clinical nutrition had a higher priority in units with frequent visits by clinical dietitians. CONCLUSIONS: The present study shows that doctors and nurses on wards with greater access to clinical dietitians had better focus on clinical nutrition.
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| 21. |
- Thoresen, L., et al.
(author)
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Lived Observations: Linking the Researcher's Personal Experiences to Knowledge Development
- 2015
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In: Qualitative Health Research. - : SAGE Publications. - 1049-7323 .- 1552-7557. ; 25:11, s. 1589-1598
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Journal article (peer-reviewed)abstract
- As researchers in palliative care, we recognize how involvement with seriously ill and dying persons has an impact on us. Using one's own senses, emotional and bodily responses in observations might open intersubjective dimensions of the research topic. The aim of the article is to highlight how phenomenological theories on intersubjectivity can be useful to develop rich and transparent data generation and analysis. We present three field note examples from observation in a hospice ward, which illuminate how researcher awareness of aspects of intersubjectivity can add valuable insights to data and analysis. Out of the examples, we elaborate on three arguments: (a) how the researcher's lived experience of time and space during fieldwork triggers new research questions, (b) how observations as an embodied activity can bring new insights and open new layers of meaning, and (c) the value of observations in gaining insight into relational aspects in a hospice.
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| 22. |
- Villa, Luisa L., et al.
(author)
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Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection
- 2007
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In: Journal of Infectious Diseases. - : Oxford University Press (OUP). - 1537-6613 .- 0022-1899. ; 196:10, s. 1438-1446
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Journal article (peer-reviewed)abstract
- Background. A quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle (VLP) vaccine has been shown to be 95%-100% effective in preventing cervical and genital disease related to HPV-6,-11,-16, and-18 in 16-26-year-old women naive for HPV vaccine types. Because most women in the general population are sexually active, some will have already been infected with >= 1 HPV vaccine types at the time vaccination is offered. Here, we assessed whether such infected women are protected against disease caused by the remaining HPV vaccine types. Methods. Two randomized, placebo-controlled trials of the quadrivalent (types 6, 11, 16, and 18) HPV vaccine enrolled 17,622 women without consideration of baseline HPV status. Among women infected with 1-3 HPV vaccine types at enrollment, efficacy against genital disease related to the HPV vaccine type or types for which subjects were naive was assessed. Results. Vaccination was 100% effective (95% confidence interval [CI], 79%-100%) in preventing incident cervical intraepithelial neoplasia 2 or 3 or cervical adenocarcinoma in situ caused by the HPV type or types for which the women were negative at enrollment. Efficacy for preventing vulvar or vaginal HPV-related lesions was 94% (95% CI, 81%-99%). Conclusions. Among women positive for 1-3 HPV vaccine types before vaccination, the quadrivalent HPV vaccine protected against neoplasia caused by the remaining types. These results support vaccination of the general population without prescreening.
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| 24. |
- Wang, HG, et al.
(author)
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Interval cancers in the Norwegian Breast Cancer Screening Program : Frequency, characteristics and use of HRT
- 2001
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In: International Journal of Cancer. - 0020-7136 .- 1097-0215. ; 94:4, s. 594-598
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Journal article (peer-reviewed)abstract
- Breast cancers diagnosed between screening examinations among women who attend a breast cancer screening program are defined as interval cancers. The Norwegian Breast Cancer Screening Program started as a pilot project in 1996, and data from the first 2-year interval are available. Our study quantifies interval cancers in the pilot project and explores characteristics and factors that may be associated with interval cancer. Interval cancers in the screening population were identified through the Cancer Registry of Norway. The frequency of invasive interval cancer was calculated as cases per 10,000 screened and as observed/expected ratio. Characteristics of the interval cancers were compared to screening-detected and clinical cancers. Breast density was assessed in a blinded review of 3 categories of screening mammograms. Information on hormone replacement therapy (HRT) use was collected from a questionnaire. The frequency of invasive interval cancers was 18.2 (15.9-20.7) per 10,000 screened and the observed/expected ratio was 0.49 (0.43-0.56). The frequency in the second year of the interval was higher than reported from other programs. The median tumor size of the interval cancers was 19.5 mm and 44.0% of the patients had affected axillary lymph nodes. The interval cancer cases had higher proportions of dense breasts and reported use of HRT compared to screen normal and screening-detected cases. The reported frequency of interval cancers is similar to comparable programs. The interval cancers differed significantly from the cancers detected in the first screening round and were more similar to clinical cancers. Interval cancer was associated with dense breasts and use of HRT. Screening programs must keep these associations in focus. (C) 2001 Wiley-Liss, Inc.
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