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279 results on '"Gedeborg, Rolf"'

12. Association between SARS-CoV-2 vaccination and healthcare contacts for menstrual disturbance and bleeding in women before and after menopause: nationwide, register based cohort study

Author

Ljung, Rickard, primary, Xu, YiYi, additional, Sundström, Anders, additional, Leach, Susannah, additional, Hallberg, Ebba, additional, Bygdell, Maria, additional, Larsson, Maria, additional, Arthurson, Veronica, additional, Gisslén, Magnus, additional, Gedeborg, Rolf, additional, and Nyberg, Fredrik, additional

Published
2023
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23. Federated analyses of multiple data sources in drug safety studies.

Author

Gedeborg, Rolf, Igl, Wilmar, Svennblad, Bodil, Wilén, Peter, Delcoigne, Bénédicte, Michaëlsson, Karl, Ljung, Rickard, and Feltelius, Nils

Abstract

Purpose: Studies of rare side effects of new drugs with limited exposure may require pooling of multiple data sources. Federated Analyses (FA) allow real‐time, interactive, centralized statistical processing of individual‐level data from different data sets without transfer of sensitive personal data. Methods: We review IT‐architecture, legal considerations, and statistical methods in FA, based on a Swedish Medical Products Agency methodological development project. Results: In a review of all post‐authorisation safety studies assessed by the EMA during 2019, 74% (20/27 studies) reported issues with lack of precision in spite of mean study periods of 9.3 years. FA could potentially improve precision in such studies. Depending on the statistical model, the federated approach can generate identical results to a standard analysis. FA may be particularly attractive for repeated collaborative projects where data is regularly updated. There are also important limitations. Detailed agreements between involved parties are strongly recommended to anticipate potential issues and conflicts, document a shared understanding of the project, and fully comply with legal obligations regarding ethics and data protection. FA do not remove the data harmonisation step, which remains essential and often cumbersome. Reliable support for technical integration with the local server architecture and security solutions is required. Common statistical methods are available, but adaptations may be required. Conclusions: Federated Analyses require competent and active involvement of all collaborating parties but have the potential to facilitate collaboration across institutional and national borders and improve the precision of postmarketing drug safety studies. [ABSTRACT FROM AUTHOR]

Published
2023
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35. Rapid ascertainment of uptake of a new indication for abiraterone by use of three nationwide health care registries in Sweden

Author

Fallara, Giuseppe, Lissbrant, Ingela Franck, Styrke, Johan, Montorsi, Francesco, Gedeborg, Rolf, Sandin, Fredrik, and Stattin, Pär

Subjects
male, priority journal, Sweden, Letter, cancer hormone therapy, prostate cancer, major clinical study, drug indication, drug uptake, Urologi och njurmedicin, cancer registry, cross-sectional study, Urology and Nephrology, controlled study, human
Published
2021

39. Cardiovascular diseases and risk of hip fracture

Author

Sennerby, Ulf, Melhus, Hakan, Gedeborg, Rolf, Byberg, Liisa, Garmo, Hans, Ahlbom, Anders, Pedersen, Nancy L., and Michaelsson, Karl

Subjects
Twins -- Genetic aspects, Twins -- Health aspects, Cardiovascular diseases -- Genetic aspects, Cardiovascular diseases -- Diagnosis, Cardiovascular diseases -- Risk factors, Hip joint -- Fractures, Hip joint -- Risk factors
Abstract

A study was conducted to evaluate the relationship between cardiovascular disease (CVD) and the risk of hip fractures among twins and the role of genetics and lifestyle factors on the association. Results indicated that a diagnosis of CVD was significantly associated with a risk of such fractures and genetics also played an important role in it.

Published
2009

40. Androgen deprivation therapy, comorbidity, cancer stage and mortality from COVID-19 in men with prostate cancer.

Author

Gedeborg, Rolf, Lindhagen, Lars, Loeb, Stacy, Styrke, Johan, Garmo, Hans, and Stattin, Pär

Subjects
*PROSTATE cancer, *SARS-CoV-2, *ANDROGEN deprivation therapy, *PROSTATE cancer patients, *CANCER-related mortality, *COVID-19
Abstract

Androgens facilitate entrance of the severe acute respiratory syndrome coronavirus 2 into respiratory epithelial cells, and male sex is associated with a higher risk of death from corona virus disease (COVID-19). Androgen deprivation therapy (ADT) could possibly improve COVID-19 outcomes. In a case–control study nested in the Prostate Cancer data Base Sweden (PCBaSe) RAPID 2019, we evaluated the association between ADT and COVID-19 as registered cause of death in men with prostate cancer. Each case was matched to 50 controls by region. We used conditional logistic regression to adjust for confounders and also evaluated potential impact of residual confounding. We identified 474 men who died from COVID-19 in March–December 2020. In crude analyses, ADT exposure was associated with an increased risk of COVID-19 death (odds ratio [OR] 5.05, 95% CI: 4.18–6.10); however, the OR was substantially attenuated after adjustment for age, comorbidity, prostate cancer characteristics at diagnosis, recent healthcare use, and indicators of advanced cancer (adjusted OR 1.25, 95% CI: 0.95–1.65). If adjustment has accounted for at least 85% of confounding, then the true effect could be no more than a 5% reduction of the odds for COVID-19 death. The increased mortality from COVID-19 in men with prostate cancer treated with ADT was mainly related to high age, comorbidity, and more advanced prostate cancer. There was no evidence to support the hypothesis that ADT is associated with improved COVID-19 outcomes. [ABSTRACT FROM AUTHOR]

Published
2022
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48. Plasma vitamin D and mortality in older men: a community-based prospective cohort study

Author

Michaelsson, Karl, Baron, John A., Snellman, Greta, Gedeborg, Rolf, Byberg, Liisa, Sundstrom, Johan, Berglund, Lars, Arnlov, Johan, Hellman, Per, Blomhoff, Rune, Wolk, Alicja, Garmo, Hans, Holmberg, Lars, and Melhus, Hakan

Subjects
Aged -- Health aspects, Aged -- Physiological aspects, Mortality -- United States, Mortality -- Research, Alfacalcidol -- Physiological aspects, Alfacalcidol -- Research, Calcifediol -- Physiological aspects, Calcifediol -- Research, Vitamin D -- Physiological aspects, Vitamin D -- Research, Food/cooking/nutrition, Health
Abstract

Background: Vitamin D status is known to be important for bone health but may also affect the development of several chronic diseases, including cancer and cardiovascular diseases, which are 2 major causes of death. Objective: We aimed to examine how vitamin D status relates to overall and cause-specific mortality. Design: The Uppsala Longitudinal Study of Adult Men, a community-based cohort of elderly men (mean age at baseline: 71 y; n = 1194), was used to investigate the association between plasma 25-hydroxyvitamin D [25(OH)D] and mortality. Total plasma 25(OH)D was determined with HPLC atmospheric pressure chemical ionization mass spectrometry. Proportional hazards regression was used to compute hazard ratios (HRs). Results: During follow-up (median: 12.7 y), 584 (49%) participants died. There was a U-shaped association between vitamin D concentrations and total mortality. An approximately 50% higher total mortality rate was observed among men in the lowest 10% (98 nmol/L) of plasma 25(OH)D concentrations compared with intermediate concentrations. Cancer mortality was also higher at low plasma concentrations (multivariable-adjusted HR: 2.20; 95% CI: 1.44, 3.38) and at high concentrations (HR: 2.64; 95% CI: 1.46, 4.78). For cardiovascular death, only low (HR: 1.89; 95% CI: 1.21, 2.96) but not high (HR: 1.33; 95% CI: 0.69, 2.54) concentrations indicated higher risk. Conclusions: Both high and low concentrations of plasma 25(OH)D are associated with elevated risks of overall and cancer mortality. Low concentrations are associated with cardiovascular mortality. Am J Clin Nutr 2010;92:841-8. doi: 10.3945/ajcn.2010.29749.

Published
2010

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