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Background: Experimental and epidemiologic data suggest that higher circulating prolactin is associated with breast cancer risk; however, how various risk factors for breast cancer influence prolactin levels in healthy women is not clear.Methods: We analyzed cross-sectional associations between several suggested reproductive and lifestyle risk factors for breast cancer and circulating prolactin among pre- and postmenopausal women, taking into account the use of current postmenopausal hormone therapy, among 2,560 controls from a breast cancer nested case–control study within the EPIC cohort.Results: Adjusted geometric mean prolactin levels were significantly higher among premenopausal women, and among postmenopausal women using hormone therapy compared with nonusers (8.2, 7.0, and 6.3 ng/mL, respectively; Pcat = Pcat = 0.001). Prolactin levels were lower among parous women compared with nulliparous women (8.61 vs. 10.95 ng/mL; Pcat = 0.0002, premenopausal women); the magnitude of this difference depended on the number of full-term pregnancies (22.1% lower, ≥3 vs. 1 pregnancy, Ptrend = 0.01). Results for parity were similar but lower in magnitude among postmenopausal women. Prolactin did not vary by other studied factors, with the exception of lower levels among postmenopausal smokers compared with never smokers.Conclusions: Our study shows that current hormone therapy use, especially the use of combined hormone therapy, is associated with higher circulating prolactin levels in postmenopausal women, and confirms prior findings of lower circulating prolactin in parous women.Impact: Our study extends the knowledge linking various breast cancer risk factors with circulating prolactin. Cancer Epidemiol Biomarkers Prev; 23(11); 2532–42. ©2014 AACR.

Supplementary Table S1. Adjusteda geometric mean prolactin levels, ng/ml (95% CI) by established correlates at the time of blood donation. Supplementary Table S2. Adjusteda geometric mean prolactin levels, ng/ml (95% CI) depending on the anthropometric factors. Supplementary Table S3. Adjusteda geometric mean prolactin levels, ng/ml (95% CI) depending on the lifestyle factors.

Background The internet is increasingly being used as a source of medicine-related information. People want information to facilitate decision-making and self-management, and they tend to prefer the internet for ease of access. However, it is widely acknowledged that the quality of web-based information varies. Poor interpretation of medicine information can lead to anxiety and poor adherence to drug therapy. It is therefore important to understand how people search, select, and trust medicine information. Objective The objectives of this study were to establish the extent of internet use for seeking medicine information among Norwegian pharmacy customers, analyze factors associated with internet use, and investigate the level of trust in different sources and websites. Methods This is a cross-sectional study with a convenience sample of pharmacy customers recruited from all but one community pharmacy in Tromsø, a medium size municipality in Norway (77,000 inhabitants). Persons (aged ≥16 years) able to complete a questionnaire in Norwegian were asked to participate in the study. The recruitment took place in September and October 2020. Due to COVID-19 restrictions, social media was also used to recruit medicine users. Results A total of 303 respondents reported which sources they used to obtain information about their medicines (both prescription and over the counter) and to what extent they trusted these sources. A total of 125 (41.3%) respondents used the internet for medicine information, and the only factor associated with internet use was age. The odds of using the internet declined by 5% per year of age (odds ratio 0.95, 95% CI 0.94-0.97; P=.048). We found no association between internet use and gender, level of education, or regular medicine use. The main purpose reported for using the internet was to obtain information about side effects. Other main sources of medicine information were physicians (n=191, 63%), pharmacy personnel (n=142, 47%), and medication package leaflets (n=124, 42%), while 36 (12%) respondents did not obtain medicine information from any sources. Note that 272 (91%) respondents trusted health professionals as a source of medicine information, whereas 58 (46%) respondents who used the internet trusted the information they found on the internet. The most reliable websites were the national health portals and other official health information sites. Conclusions Norwegian pharmacy customers use the internet as a source of medicine information, but most still obtain medicine information from health professionals and packet leaflets. People are aware of the potential for misinformation on websites, and they mainly trust high-quality sites run by health authorities.

The use of dietary supplements (DS) is widespread and tends to increase with age and female gender. DS use can in some situations represent a safety risk for patients. For instance, concomitant use of medication and dietary supplements, particularly herbal remedies, may cause clinically significant pharmacological interactions. The study underlying this chapter aimed to investigate the prevalence of potentially clinically significant DS-medication interactions in a general population of middle-aged women. The study is a questionnaire survey among Norwegian women born between 1943 and 1957. Data were collected from 2002 to 2006 as a part of the Norwegian Women and Cancer study (NOWAC). The participants listed all medications and all DS they had used during the previous week. The reported DS were checked for interaction potential in combination with medication, using the Natural Medicines database. The study population comprised 3,970 women, of whom 1,885 combined medication and dietary supplements. Overall, 630 (16% of the total population) used a DS-medication combination with a potential for at least one clinically significant interaction. Of these, 132 women used herb-medication combinations, 63 used combination(s) that represented more than two interactions, and three used combinations classified as a major health risk. There is considerable potential for clinically significant medication-supplement interactions in a general population such as the one described in the study. Although few of the identified interactions represent a major health risk, the findings indicate that health personnel should take supplements into account when assessing the safety of medication use among their patients.

Objective To explore home care services (HCS) employees' professional experiences with the use of dietary supplements (DSs) in their clients with dementia. We also investigated their attributed professional responsibility concerning this use and their attitudes toward DSs in general. Differences between nurses and nurse assistants were investigated. Design A cross-sectional survey with self-administered questionnaires. Setting Home care services in six Norwegian municipalities in the period August-December 2016. Subjects A total of 231 (64% response rate) HCS employees; 78 nurses and 153 nurse assistants (auxiliary nurses and employees without formal education). Main outcome measures: Health care employees’ experiences with patient safety in clients with dementia who use DSs. Results Fifty per cent were concerned that clients with dementia might harm their health due to DS use. Thirty-one per cent reported having intervened in order to reduce the risk. Seventy-one per cent preferred to administer DSs to clients with dementia rather than leaving this responsibility to the clients. The respondents placed the responsibility for patient safety in clients with dementia using DSs mainly with the general practitioners, while they ascribed themselves and pharmacies a medium level of responsibility. There were only minor difference between nurses and nurse assistants, and no difference in attitudes towards DSs. Conclusion Employees in HCS were concerned about the DS use in clients with dementia. Moreover, almost one-third had intervened to improve clients' patient safety. The majority indicated that HCS should administer DSs rather than the clients with dementia themselves.KEY POINTSTo our knowledge, this is the first study investigating the role of home care services with regard to patient safety in clients with dementia who use dietary supplements (DSs).•Home care service employees worried about patient safety related to DS use in clients with dementia.•Home care service employees attributed to themselves medium responsibility to ensure the safe use of DSs in these clients.•Lack of knowledge was the most important reason why home care service employees did not recommend DSs to clients.

Marit Waaseth,1,2 Martina Havelkova,1 Guro Forsdahl,1 Eiliv Lund,3 Tomas Log2,4 1Department of Pharmacy, UiT the Arctic University of Norway, Tromsø, Norway; 2Northern Norway Regional Health Authority, Tromsø, Norway; 3Department of Community Medicine, UiT the Arctic University of Norway, Tromsø, Norway; 4Faculty of Nursing and Health Sciences, Nord University, Mo i Rana, NorwayCorrespondence: Marit Waaseth, Department of Pharmacy, UiT The arctic university of Norway, PO Box 6050 Langnes, Tromsø, N-9037, Norway, Tel +47 776 46192, Email marit.waaseth@uit.noPurpose: To validate self-reported current use of selective serotonin reuptake inhibitors (SSRI) in the Norwegian Women and Cancer study (NOWAC) and to identify factors associated with discordance between data sources.Material and Methods: This is a cross-sectional record-linkage study comparing SSRI-use derived from four data sources: 1) Specific SSRI questions in the main NOWAC questionnaire, 2) Open questions on medication use in the small questionnaire following blood samples, 3) plasma concentration measurements for a subsample, and 4) pharmacy dispensations from the Norwegian prescription database (NorPD) where current use of SSRI was defined by Legend Time Duration (LTD). Among 105 855 women, aged 46 to 64 years and randomly selected from the general population, 70,191 had data on SSRI-use from both NOWAC and NorPD. Plasma concentration was measured for 93 pairs of self-reported SSRI-users and non-users, with dispensation data available for 68 pairs. Validity was assessed by sensitivity and specificity; agreement was assessed by Cohen’s kappa. Factors associated with discordance between information sources were analyzed by multiple binary logistic regression.Results: We found high sensitivity (89.5%) and specificity (98.7%) for the specific questions in the main questionnaire compared with pharmacy dispensations. Measured against plasma concentrations, current SSRI-use defined by open questions and pharmacy dispensations both had high sensitivity (100% and 92.5%, respectively) and specificity (98.6% both). Agreements (kappa) were similarly high for all comparisons (≥ 0.80). The factors associated with discordance between data sources included poor health, comorbidity, being single and not being in full time work. Education was inversely associated with discordance.Conclusion: Self-reported current use of SSRI from the NOWAC questionnaires is highly valid and, according to plasma concentrations, perhaps even more so than pharmacy dispensations. Factors associated with discordance between information sources should be taken into account in the interpretation of future analyses which include SSRI-use in the NOWAC study.Keywords: antidepressants, self-report, plasma concentration, pharmacy dispensations, record linkage, agreement

The EPIC-CVD project was supported by the European Union Framework 7 (HEALTH-F2-2012-279233), the European Research Council (268834), the UK Medical Research Council (G0800270, MR/L003120/1), the British Heart Foundation (SP/09/002, RG/08/014, RG13/13/30194), and the UK National Institute of Health Research (to EPIC-CVD). The establishment of the subcohort was supported by the EU Sixth Framework Programme (FP6) (grant LSHM_CT_2006_037197 to the InterAct project) and the Medical Research Council Epidemiology Unit (grants MC_ UU_12015/1 and MC_UU_12015/5). The national EPIC cohorts are supported by Danish Cancer Society (Denmark); Ligue Contre le Cancer, Institut Gustave Roussy, Mutuelle Generale de l'Education Nationale, Institut National de la Sante et de la Recherche Medicale (INSERM) (France); Deutsche Krebshilfe, Deutsches Krebsforschungszentrum and Federal Ministry of Education and Research (Germany); Ministry of Health and Social Solidarity, Stavros Niarchos Foundation and Hellenic Health Foundation (Greece); Italian Association for Research on Cancer (AIRC) and National Research Council (Italy) and MIUR "Dipartimenti di Eccellenza"(Project D15D18000410001) to the Department of Medical Sciences; Dutch Ministry of Public Health, Welfare and Sports (VWS), LK Research Funds, Dutch Prevention Funds, Dutch ZON (Zorg Onderzoek Nederland), World Cancer Research Fund (WCRF); ERC-2009-AdG 232997 and Nordforsk, Nordic Centre of Excellence programme on Food, Nutrition and Health (Norway); Health Research Fund (FIS), Regional Governments of Andalucia, Asturias, Basque Country, Murcia and Navarra, ISCIII RETIC (RD06/0020) (Spain); Swedish Cancer Society, Swedish Scientific Council and Regional Government of Skane and Vasterbotten (Sweden); and Cancer Research UK, Medical Research Council (United Kingdom). LIFE-Heart is funded by the Leipzig Research Center for Civilization Diseases (LIFE). LIFE is an organizational unit affiliated to the Medical Faculty of the University of Leipzig. LIFE is funded by means of the European Union, by the European Regional Development Fund (ERDF), and by funds of the Free State of Saxony within the framework of the excellence initiative. This work is supported by the Dutch Heart Foundation (2013T083 to V.D.), by a UK Medical Research Council Skills Development Fellowship (MR/P014550/1 to S.A.E.P.), and by a Sir Henry Dale Fellowship jointly funded by the Welcome Trust and the Royal Society (204623/Z/16/Z to S.B.). None of the funding sources had a role in the collection, analysis, and interpretation of the data, nor in the decision to submit the article for publication., Background: Accelerated reproductive aging, in women indicated by early natural menopause, is associated with increased coronary heart disease (CHD) risk in observational studies. Conversely, an adverse CHD risk profile has been suggested to accelerate menopause. Objectives: To study the direction and evidence for causality of the relationship between reproductive aging and (non-)fatal CHD and CHD risk factors in a bidirectional Mendelian randomization (MR) approach, using age at natural menopause (ANM) genetic variants as a measure for genetically determined reproductive aging in women. We also studied the association of these variants with CHD risk (factors) in men. Design: Two-sample MR, using both cohort data as well as summary statistics, with 4 methods: simple and weighted median-based, standard inverse-variance weighted (IVW) regression, and MR-Egger regression. Participants: Data from EPIC-CVD and summary statistics from UK Biobank and publicly available genome-wide association studies were pooled for the different analyses. Main Outcome Measures: CHD, CHD risk factors, and ANM. Results: Across different methods of MR, no association was found between genetically determined reproductive aging and CHD risk in women (relative risk estimateIVW = 0.99; 95% confidence interval (CI), 0.97-1.01), or any of the CHD risk factors. Similarly, no associations were found in men. Neither did the reversed analyses show evidence for an association between CHD (risk factors) and reproductive aging. Conclusion: Genetically determined reproductive aging is not causally associated with CHD risk (factors) in women, nor were the genetic variants associated in men. We found no evidence for a reverse association in a combined sample of women and men., European Commission HEALTH-F2-2012-279233 European Research Council (ERC) European Commission 268834, UK Research & Innovation (UKRI) Medical Research Council UK (MRC) G0800270 MR/L003120/1 British Heart Foundation SP/09/002 RG/08/014 RG13/13/30194, National Institute for Health Research (NIHR), EU Sixth Framework Programme (FP6) LSHM_CT_2006_037197, UK Research & Innovation (UKRI), Medical Research Council UK (MRC) MC_ UU_12015/1 MC_UU_12015/5, Danish Cancer Society, Ligue Contre le Cancer (France), Institut Gustave Roussy (France), Mutuelle Generale de l'Education Nationale (France), Institut National de la Sante et de la Recherche Medicale (Inserm), Deutsche Krebshilfe Federal Ministry of Education & Research (BMBF) Deutsches Krebsforschungszentrum (Germany), Ministry of Health and Social Solidarity (Greece) Stavros Niarchos Foundation (Greece) Hellenic Health Foundation (Greece), Fondazione AIRC per la ricerca sul cancro Consiglio Nazionale delle Ricerche (CNR) MIUR "Dipartimenti di Eccellenza" D15D18000410001, Dutch Ministry of Public Health, Welfare and Sports, LK Research Funds, Dutch Prevention Funds Netherlands Organization for Scientific Research (NWO), World Cancer Research Fund International (WCRF) ERC-2009-AdG 232997, Nordforsk, Nordic Centre of Excellence programme on Food, Nutrition and Health (Norway), Instituto de Salud Carlos III, Junta de Andalucia, Principality of Asturias, Regional Government of Basque Country (Spain) Regional Government of Murcia (Spain) Regional Government of Navarra (Spain), Instituto de Salud Carlos III RD06/0020, Swedish Cancer Society Swedish Scientific Council (Sweden) Regional Government of Skane and Vasterbotten (Sweden), Cancer Research UK UK Research & Innovation (UKRI) Medical Research Council UK (MRC), Leipzig Research Center for Civilization Diseases (LIFE), European Commission, Free State of Saxony, Netherlands Heart Foundation 2013T083, Medical Research Council UK (MRC) MR/P014550/1, Sir Henry Dale Fellowship - Welcome Trust 204623/Z/16/Z, Sir Henry Dale Fellowship - Royal Society 204623/Z/16/Z

Purpose To determine the prevalence and associated factors of self-reported medication information needs among medication users in a general population aged 40 years and above – The Tromsø Study. Methods Cross-sectional study of medication users (n = 10,231) among participants in the Tromsø Study, a descriptive analysis of questionnaire data and multivariable logistic regression (n = 9,194). Results Sixteen percent of medication users expressed a need for more information about own medications. Overall, medication users agreed to a higher degree to have received information from the GP compared to the pharmacy. Concerned medication users and those disagreeing to have received information about side effects had the highest odds for needing more information (OR 5.07, 95% CI 4.43–5.81) and (OR 2.21, 95% CI 1.83–2.68), respectively. Medication users who used heart medications (e.g., nitroglycerin, antiarrhythmics, anticoagulants) (OR 1.71, 95% CI 1.46–2.01), medication for hypothyroidism (OR 1.36, 95% CI 1.13–1.64) or had moderately health anxiety had expressed need for medication information. Whereas medication users with lower education, those that never used internet to search for health advice, and medication users who disagreed to have received information about reason-for-use were associated with lower odds (OR 0.75, 95% CI 0.62–0.91), (OR 0.85, 95% CI 0.74–0.98) and (OR 0.68, 95% CI 0.53–0.88), respectively. Conclusion This study demonstrated that there is need for more information about own medications in a general population aged 40 years and above and shed light on several characteristics of medication users with expressed information need which is important when tailoring the right information to the right person.

This work was supported by the French National Cancer Institute (INCa SHSESP17, grant No. 2017-127 to N. Murphy). The coordination of EPIC is financially supported by International Agency for Research on Cancer (IARC) and also by the Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, which has additional infrastructure support provided by the NIHR Imperial Biomedical Research Centre (BRC). The national cohorts are supported by: Danish Cancer Society (Denmark); Ligue Contre le Cancer, Institut Gustave Roussy, Mutuelle Generale de l'Education Nationale, Institut National de la Sante et de la Recherche Medicale (INSERM) (France); German Cancer Aid, German Cancer Research Center (DKFZ), German Institute of Human Nutrition PotsdamRehbruecke (DIfE), Federal Ministry of Education and Research (BMBF) (Germany); Associazione Italiana per la Ricerca sul Cancro-AIRC-Italy, Compagnia di SanPaolo and National Research Council (Italy); Dutch Ministry of Public Health, Welfare and Sports (VWS), Netherlands Cancer Registry (NKR), LK Research Funds, Dutch Prevention Funds, Dutch ZON (Zorg Onderzoek Nederland), World Cancer Research Fund (WCRF), Statistics Netherlands (the Netherlands); Health Research Fund (FIS) - Instituto de Salud Carlos III (ISCIII), Regional Governments of Andalucia, Asturias, Basque Country, Murcia and Navarra, and the Catalan Institute of Oncology-ICO (Spain); Swedish Cancer Society, Swedish Research Council and County Councils of Ska degrees ne and V_asterbotten (Sweden); Cancer Research UK (14136 to EPIC-Norfolk; C8221/A29017 to EPIC-Oxford), Medical Research Council (1000143 to EPIC-Norfolk; MR/M012190/1 to EPIC-Oxford) (United Kingdom)., Background: Observational studies have consistently reported that postmenopausal hormone therapy use is associated with lower colon cancer risk, but epidemiologic studies examining the associations between circulating concentrations of endogenous estrogens and colorectal cancer have reported inconsistent results. Methods: We investigated the associations between circulating concentrations of estrone, estradiol, free estradiol, testosterone, free testosterone, androstenedione, dehydroepiandrosterone (DHEA), progesterone, and sex hormone–binding globulin (SHBG) with colon cancer risk in a nested case-control study of 1028 postmenopausal European women (512 colon cancer cases, 516 matched controls) who were noncurrent users of exogenous hormones at blood collection. Multivariable conditional logistic regression models were used to compute odds ratios and 95% confidence intervals to evaluate the association between circulating sex hormones and colon cancer risk. We also conducted a dose-response meta-analysis of prospective studies of circulating estrone and estradiol with colorectal, colon, and rectal cancer risk in postmenopausal women. All statistical tests were 2-sided. Results: In the multivariable model, a nonstatistically significantly positive relationship was found between circulating estrone and colon cancer risk (odds ratio per log2 1-unit increment¼1.17 [95% confidence interval¼1.00 to 1.38]; odds ratioquartile4-quartile1¼1.33 [95% confidence interval¼0.89 to 1.97], Ptrend¼.20). Circulating concentrations of estradiol, free estradiol, testosterone, free testosterone, androstenedione, DHEA, progesterone, and SHBG were not associated with colon cancer risk. In the doseresponse meta-analysis, no clear evidence of associations were found between circulating estradiol and estrone concentrations with colorectal, colon, and rectal cancer risk. Conclusion: Our observational and meta-analysis results do not support an association between circulating concentrations of endogenous sex hormones and colon or rectal cancer in postmenopausal women., French National Cancer Institute (INCa SHSESP17) 2017-127, World Health Organization, Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, Danish Cancer Society, Ligue Contre le Cancer (France), Institut Gustave Roussy (France), Mutuelle Generale de l'Education Nationale (France), Institut National de la Sante et de la Recherche Medicale (Inserm), Deutsche Krebshilfe German Cancer Research Center (DKFZ) (Germany) German Institute of Human Nutrition Potsdam Rehbruecke (DIfE) (Germany), Federal Ministry of Education & Research (BMBF), Fondazione AIRC per la ricerca sul cancro, Compagnia di San Paolo Consiglio Nazionale delle Ricerche (CNR), Netherlands Government, World Cancer Research Fund International (WCRF), Health Research Fund (FIS) - Instituto de Salud Carlos III (ISCIII) (Spain) Junta de Andalucia Regional Government of Asturias (Spain) Regional Government of Basque Country (Spain) Regional Government of Murcia (Spain) Regional Government of Navarra (Spain) Catalan Institute of Oncology-ICO (Spain), Swedish Cancer Society Swedish Research Council County Council of Skane (Sweden) County Council of Vasterbotten (Sweden), Cancer Research UK 14136 C8221/A29017 UK Research & Innovation (UKRI) Medical Research Council UK (MRC) 1000143 MR/M012190/1

Purpose To describe medication adherence to lipid-lowering drugs (LLDs), antihypertensive drugs, and acetylsalicylic acid (ASA) among persons with coronary heart disease (CHD) and explore its association with low-density-lipoprotein (LDL)-cholesterol, and systolic and diastolic blood pressure. Methods Based on record linkage between the seventh wave of the Tromsø Study and the Norwegian Prescription Database, medication adherence was calculated as the proportion of days covered (PDC) for persistent prevalent users in the period of 365 days before the attendance date. Multivariable linear regression models were used to assess the association between systolic and diastolic blood pressure and medication nonadherence to antihypertensive drugs, age, sex, lifestyle, body mass index (BMI), current and previous diabetes, and between LDL-cholesterol and medication nonadherence to LLDs, age, sex, lifestyle, BMI, and current and previous diabetes. Results Mean PDC was 0.94 for LLDs and antihypertensive drugs and 0.97 for ASA. Among persons with PDC ≥ 0.80 for LLDs, 12.0% had an LDL-cholesterol Conclusion Adherence to antihypertensive drugs, LLDs, and ASA among persons with CHD were high despite low achievement of treatment goals for blood pressure and LDL-cholesterol. There was a statistically significant association between adherence to LLDs and LDL-cholesterol, but not between adherence to antihypertensive drugs and blood pressure.

Adherence to clinical practice guidelines for coronary heart disease (CHD) reduces morbidity, mortality and treatment costs. We aimed to describe and compare adherence to prescription guidelines for persons with CHD, and explore its association with treatment goal achievement.We included all participants reporting myocardial infarction, angina, percutaneous coronary intervention and/or coronary artery bypass surgery in the seventh wave of the Tromsø Study (2015-2016, n = 1483). Medication use and treatment goal measures (blood pressure, low-density lipoprotein (LDL)-cholesterol and HbA1c) were compared to clinical practice guidelines on secondary CHD prevention. Propensity score matched logistic regression was used to assess the association between the use of antihypertensive drugs and achievement of treatment goal for blood pressure, and the use of lipid-lowering drugs (LLDs) and achievement of treatment goal for LDL-cholesterol.The prevalence of pharmacological CHD treatment was 76% for LLDs, 72% for antihypertensive drugs and 66% for acetylsalicylic acid. The blood pressure goal ( 140/90 mmHg, 140/80 mmHg if diabetic) was achieved by 58% and the LDL-cholesterol goal ( 1.8 mmol/l or 70 mg/dL) by 9%. There was a strong association between using LLDs and achieving the treatment goal for LDL-cholesterol (OR 14.0, 95% CI 3.6-54.7), but not between using antihypertensive drugs and blood pressure goal achievement (OR 1.4, 95% CI 0.7-2.7).Treatment goal achievement of LDL-cholesterol and blood pressure was low, despite the relatively high use of LLDs and antihypertensive drugs. Further research is needed to find the proper actions to increase achievement of the treatment goals.

The Norwegian Society for Pharmacoepidemiology (NFFE) is a multidisciplinary, nation-wide network of professionals involved in the field of pharmacoepidemiology. Pharmacoepidemiology is the science that bridges epidemiologic methodology with clinical pharmacology and clinical pharmacy, for studying the use, effectiveness, value and safety of pharmaceuticals1 . The foundation of NFFE took into account the growing value of real-world data in assessing potential benefits and risks of medication use, and capitalized on the growing availability of linkable, nation-wide health registries and large population-based cohorts in Norway. In this short commentary, we briefly describe the history and mission of the society, and our current and future activities to foster high-quality research and education at national and international level.

Objective - To validate self-reported use of medications for secondary prevention of coronary heart disease (CHD) in a population-based health study by comparing self-report with pharmacy dispensing data, and explore different methods for defining medication use in prescription databases. Study design and setting - Self-reported medication use among participants with CHD (n = 1483) from the seventh wave of the Tromsø Study was linked with the Norwegian Prescription Database (NorPD). Cohen’s kappa, sensitivity, specificity, and positive and negative predictive values were calculated, using NorPD as the reference standard. Medication use in NorPD was defined in three ways; fixed-time window of 180 days, and legend-time method assuming a daily dose of one dosage unit or one defined daily dose (DDD). Results - Kappa-values for antihypertensive drugs, lipid-lowering drugs and acetylsalicylic acid all showed substantial agreement (kappa ≥0.61). Validity varied depending on the method used for defining medication use in NorPD. Applying a fixed-time window gave higher agreement, positive predictive values and specificity compared with the legend-time methods. Conclusion - Self-reported use of medication for secondary prevention of CHD shows high validity when compared with pharmacy dispensing data. For CHD medications, fixed-time window appears to be the most appropriate method for defining medication use in prescription databases.

Receptor-defined subtypes of breast cancer represent distinct cancer types and have differences in risk factors. Whether the two main hormonal forms of oral contraceptives (OCs); i.e. progestin-only (POC) and combined oral contraceptives (COC), are differentially associated with these subtypes are not well known. The aim of our study was to assess the effect of POC and COC use on hormone receptor-defined breast cancer risk in premenopausal women in a prospective population-based cohort - The Norwegian Women and Cancer Study (NOWAC). Information on OC use was collected from 74,862 premenopausal women at baseline. Updated information was applied when follow-up information became available. Multiple imputation was performed to handle missing data, and multivariable Cox regression models were used to calculate hazard ratios (HR) for breast cancer. 1,245 incident invasive breast cancer cases occurred. POC use ≥5 years was associated with ER+ (HR = 1.59, 95% CI 1.09- 2.32, ptrend = 0.03) and ER+/PR+ cancer (HR = 1.63, 95% CI 1.07-2.48, ptrend = 0.05), and was not associated with ER- (pheterogeneity = 0.36) or ER-/PR- (pheterogeneity = 0.49) cancer. COC use was associated with ER- and ER-/PR- cancer, but did not increase risk of ER+ and ER+/PR+ cancer. Current COC use gave different estimates for ER/PR-defined subtypes (pheterogeneity = 0.04). This is the first study to show significant associations between POC use and hormone receptor-positive breast cancer. The lack of power to distinguish effects of POC use on subtype development calls for the need of larger studies to confirm our finding.

Background: Urothelial carcinoma is the predominant (95%) bladder cancer subtype in industrialized nations. Animal and epidemiologic human studies suggest that hormonal factors may influence urothelial carcinoma risk. Methods: We used an analytic cohort of 333,919 women from the European Prospective Investigation into Cancer and Nutrition Cohort. Associations between hormonal factors and incident urothelial carcinoma (overall and by tumor grade, tumor aggressiveness, and non–muscle-invasive urothelial carcinoma) risk were evaluated using Cox proportional hazards models. Results: During a mean of 15 years of follow-up, 529 women developed urothelial carcinoma. In a model including number of full-term pregnancies (FTP), menopausal status, and menopausal hormone therapy (MHT), number of FTP was inversely associated with urothelial carcinoma risk (HR≥5vs1 = 0.48; 0.25–0.90; Ptrend in parous women = 0.010) and MHT use (compared with nonuse) was positively associated with urothelial carcinoma risk (HR = 1.27; 1.03–1.57), but no dose response by years of MHT use was observed. No modification of HRs by smoking status was observed. Finally, sensitivity analyses in never smokers showed similar HR patterns for the number of FTP, while no association between MHT use and urothelial carcinoma risk was observed. Association between MHT use and urothelial carcinoma risk remained significant only in current smokers. No heterogeneity of the risk estimations in the final model was observed by tumor aggressiveness or by tumor grade. A positive association between MTH use and non–muscle-invasive urothelial carcinoma risk was observed. Conclusions: Our results support that increasing the number of FTP may reduce urothelial carcinoma risk. Impact: More detailed studies on parity are needed to understand the possible effects of perinatal hormone changes in urothelial cells.

Medication errors are associated with adverse health outcomes and may prolong hospital stays and increase societal costs. Safety initiatives to reduce adverse health outcomes should be based on reliable information of current shortcomings. The aim of this study was to identify barriers to medication error reporting in a hospital and to describe heath personnel's views of the safety culture. Seven interviews with health personnel (two doctors, four nurses and one pharmacist) were conducted November 2016-January 2017 at the University Hospital of North Norway. Nurses, more frequently than doctors, reported medication errors and discussed reported errors at staff meetings. Doctors preferred to solve the problem directly, for example writing a new medication order, rather than writing a report when a medication error had been identified. There was variation between the wards regarding the perception of support, confidence in and focus on error reporting, which indicates different safety cultures within the hospital. Identified barriers to medication error reporting included lack of time, and the impression that the reporting system is complicated and not user-friendly. Staff also reported inadequate training using the system, which could contribute to the perception that the system is inaccessible. Hospital management should take actions to improve the safety culture throughout the hospital based on the barriers identified in this study. This could include stronger focus on the importance of reporting medication errors, a transparent review process and clearly communicated actions.

Source at https://doi.org/10.1186/s12889-019-6409-x. Licensed CC BY-NC-ND 4.0. Background: Antibiotic resistance is a global health threat. Public knowledge is considered a prerequisite for appropriate use of antibiotics and limited spread of antibiotic resistance. Our aim was to examine the level of knowledge of antibiotics and antibiotic resistance among Norwegian pharmacy customers, and to assess to which degree beliefs, attitudes and sociodemographic factors are associated with this knowledge. Methods: A questionnaire based, cross-sectional study was conducted among pharmacy customers in three Norwegian cities. The questionnaire covered 1) knowledge of antibiotics (13 statements) and antibiotic resistance (10 statements), 2) the general beliefs about medicines questionnaire (BMQ general) (three subdomains, four statements each), 3) attitudes toward antibiotic use (four statements), and 4) sociodemographic factors, life style and health. High knowledge level was defined as > 66% of maximum score. Factors associated with knowledge of antibiotics and antibiotic resistance were investigated through univariate and multiple linear regression. Hierarchical model regression was used to estimate a population average knowledge score weighted for age, gender and level of education. Results: Among 877 participants, 57% had high knowledge of antibiotics in general and 71% had high knowledge of antibiotic resistance. More than 90% knew that bacteria can become resistant against antibiotics and that unnecessary use of antibiotics can make them less effective. Simultaneously, more than 30% erroneously stated that antibiotics are effective against viruses, colds or influenza. Factors positively associated with antibiotic knowledge were health professional background, high education level, and a positive view on the value of medications in general. Male gender, a less restrictive attitude toward antibiotic use, and young age were negatively associated with antibiotic knowledge. The mean overall antibiotic knowledge score was relatively high (15.6 out of maximum 23 with estimated weighted population score at 14.8). Conclusions: Despite a high level of knowledge of antibiotics and antibiotic resistance among Norwegian pharmacy customers, there are obvious knowledge gaps. We suggest that action is taken to increase the knowledge level, and particularly target people in vocational, male dominated occupations outside the health service, and primary/secondary school curricula.

Background Community-dwelling persons with dementia commonly use dietary supplements (DS), often without receiving help with the administration. Patient safety is a concern, as DS-drug interactions and adverse events are potential complications. Since many persons with dementia buy their DS in pharmacies, we investigated Norwegian pharmacy employees’ attitudes and professional practice behaviors related to DS. Methods We conducted a survey in eight Norwegian municipalities of pharmacy employees involved in the sale of DS. The questionnaire covered demographics and investigated attitudes toward DS, professional practice behaviors related to the sale of DS, experiences with customers with dementia, and perceived and attributed responsibilities with regard to patient safety. Results One hundred and five employees responded (response rate: 52%). Most employees regarded general practitioners (GPs) as primarily responsible for safeguarding the use of DS by persons with dementia and rated themselves less responsible. Thirty-seven percent of the employees reported personal use of DS (past or current use). Nine percent considered some of the DS to have symptomatic or prophylactic effects against dementia. Forty-eight percent confirmed that they informed customers about potential adverse events; 42% indicated that they did this sometimes. Sixteen percent checked regularly for DS-drug interactions, and two-thirds checked depending on the customers’ health, the type of drug or the type of DS. One-quarter regularly asked about the co-use of prescription drugs (PD) when selling DS, while only 2% asked about the co-use of DS when dispensing PD. Only 25% reported access to independent scientific information on all or most DS sold in their pharmacy. Eight percent had experienced unsafe use of DS by persons with dementia. Six percent had been taught about counselling persons with dementia. Education level influenced professional practice behavior to some extent. Conclusion Pharmacy employees do not see themselves as primarily responsible for the safe use of DS by persons with dementia. Moreover, they have limited experience with the unsafe use of DS by these persons. There is potential for improvement regarding tools and educational interventions for pharmacy employees to provide sufficient help to persons with dementia who use DS. Electronic supplementary material The online version of this article (10.1186/s12906-019-2587-4) contains supplementary material, which is available to authorized users.

Receptor-defined subtypes of breast cancer represent distinct cancer types and have differences in risk factors. Whether the two main hormonal forms of oral contraceptives (OCs); i.e. progestin-only (POC) and combined oral contraceptives (COC), are differentially associated with these subtypes are not well known. The aim of this study was to assess the effect of POC and COC use on hormone receptor-defined breast cancer risk in premenopausal women in a prospective population-based cohort – The Norwegian Women and Cancer study (NOWAC). Information on OC use was collected from 74,862 premenopausal women at baseline. Updated information was applied when follow-up information became available. Multiple imputation was performed to handle missing data, and multivariable Cox regression models were used to calculate hazard ratios (HR) for breast cancer. 1245 incident invasive breast cancer cases occurred. POC use ≥ five years was associated with ER+ (HR = 1.59, 95% CI 1.09 – 2.32, p(trend) = 0.03) and ER+/PR+ cancer (HR = 1.63, 95% CI 1.07 – 2.48, p(trend) = 0.05), and was not associated with ER− (p(heterogeneity) = 0.36) or ER−/PR− (p(heterogeneity) = 0.49) cancer. COC use was associated with ER− and ER−/PR− cancer, but did not increase risk of ER+ and ER+/PR+ cancer. Current COC use gave different estimates for ER/PR-defined subtypes (p(heterogeneity) = 0.04). This is the first study to show significant associations between POC use and hormone receptor-positive breast cancer. The lack of power to distinguish effects of POC use on subtype development calls for the need of larger studies to confirm our finding.

I1 World Congress for Integrative Medicine & Health 2017 - A global forum for exploring the future of comprehensive patient care Benno Brinkhaus1, Torkel Falkenberg2,3, Aviad Haramati4,5, and Stefan N. Willich1 1Institute for Social Medicine, Epidemiology and Health Economics, Charite – Universitatsmedizin Berlin, Berlin, Germany; 2Department of Neurobiology Care Sciences and Society, Division of Nursing, Research Group Integrative Care, Karolinska Institutet, Stockholm, Sweden; 3I C – The Integrative Care Science Center, Jarna, Sweden; 4Department of Biochemistry, Molecular and Cellular Biology, Georgetown University, Medical Center, Washington, DC, USA; 5Department of Medicine, Georgetown University Medical Center, Washington, DC, USA We are excited to present the abstracts of the keynote speakers, parallel sessions and oral and poster presentations of the World Congress on Integrative Medicine & Health (WCIMH 2017; http://www.ecim-iccmr.org/2017/) to be held in Berlin on May 3-5, 2017, which will be jointly convened by the European Society of Integrative Medicine (ESIM) and the International Society for Complementary Medicine Research (ISCMR). The Congress will take place in association with a number of national and international organizations from North America and other continents. Consequently, the congress will provide the most comprehensive global forum and perspective in the field of Complementary and Integrative Medicine in 2017. The congress goal is reflected in its tag line: The Future of Comprehensive Patient Care - Strengthening the Alliance of Researchers, Educators and Providers. We believe that by bringing together researchers, educators and providers, who are addressing various aspects of Integrative Medicine and health, we can build on the evidence obtained through research to inform clinical education and practice and thereby create a better platform for comprehensive patient care. The main themes of the Congress are: Clinical care: The practice of Integrative Medicine should be based on distinct definitions, should be informed by evidence and evolve from guidelines that are developed by experts from conventional and complementary medicine. Education: Academic leaders and health officials have called for future clinicians to possess the knowledge and skills to understand how Integrative Medicine can be incorporated into conventional care to improve the health of the public. Therefore, it is essential to share best practices in how to create robust curricular opportunities for medical students to experience systematic teaching of the principles, strengths and limitations of Integrative Medicine. Research: Within this Congress scientists will showcase the highest quality research worldwide in this field and will provide the state-of-the-science evidence base through plenary lectures, symposia and abstract presentations. Traditional healing systems (THS): Traditional healing practices and practitioners are an important and often underestimated part of health care. THS is found in almost every country in the world and the demand for its services is increasing. Research contributing to evidence informed decision making is imperative to develop a cohesive and integrative approach to health care that allows governments, health care practitioners and, most importantly, those who use health care services, to access THS in a safe, respectful, cost-efficient and effective manner. Arts and medicine: For the first time at a research congress, this theme will explore the important contributions of the arts (music, visual arts, dancing, etc,) for integrative therapeutic interventions to achieve optimal health and healing. Given the ambitious scope of this worldwide international congress, the four authors of the present editorial serve as co-presidents and they are guided by the International Organizing Committee consisting of many experts from around the world including Myeong S. Lee, Jianping Liu, Kenji Watanabe (from Far East Asia), Renee Street (Africa), Amie. Steel (Australia), Paulo Arturo Caceres Guido, Chin An Lin (South America), Heather Boon, Josephine Briggs, John Weeks (North America) and Abdullah Al-Bedah, Mohamed Khalil, Elad Schiff (Middle East and Israel). The programming for each of the five themes is directed by WCIMH 2017 theme subcommittees involving some of the most highly regarded clinicians, educators and researchers in the world in this field (in alphabetic order): Linda Balneaves, Lesley Braun, Eva Bojner Horwitz, Gustav Dobos, Jeffery Dusik, David Eisenberg, Iva Fattorini, Eckhart G. Hahn, Suzanne B. Hanser, Frederick Hecht, George Lewith, Harald Matthes, Andreas Michalsen, Judy Rollins, Volker Scheid, Michael Teut, Robert Saper, Claudia M. Witt, Merlin Wilcox and Darong Wu. The Local Organizing Board is coordinated by M. Cree. We are very grateful to all organisations and individuals working diligently to making this first World Congress for Integrative Medicine & Health in 2017 a great success. We are also pleased to announce that the opening welcome will include the Director General for the World Health Organization, Dr Margaret Chan (on video). All plenary speakers are internationally recognized experts in the field of Complementary and Integrative Medicine such as Josephine B Briggs (US) and Merlin Willcox (UK) as keynote speakers for the theme traditional healing systems; Klaus Linde (Ger) and Michael Moore (UK) for the research theme; Lisa M Wong (US) and Tores Theorell (Sweden) will address the theme of arts and medicine; Darong Wu (China) and Jeffery A Dusek (US) are presenting on the theme of clinical care; and Aviad Haramati and David Eisenberg (both US) will close the Congress with presentations on education. In addition, more than 100 oral presentations in over 40 parallel sessions will be in the program to provide newly emerging data from recent research projects, experiences from new treatment aspects in clinical care, descriptions of new models of education in medicine, information about integration of traditional healing systems in health care systems and new aspects on the integration of arts in medicine. In addition, more than 400 posters will be presented in guided poster sessions during the three days of the Congress. To translate the congress goals and objectives into a tangible action for the field, a Berlin Agreement is being developed. With the title ‘Social and Self-responsibility in practicing and fostering Integrate Health and Medicine Globally,’ this document is meant to help shape the future of comprehensive patient care in Integrative Medicine, and addresses the responsibilities of all participants, including patients and citizens, physicians and all colleagues working in the healthcare system. The Berlin Agreement has been developed by the WCIMH 2017 congress presidents and the International Organizing Committee to create a document for further distribution to the scientific and clinical community and to health care stakeholders, decision makers, and politicians. We anticipate having the final version of the Berlin Agreement endorsed by a number of organizations prior to the Congress and also soliciting the support of congress at the WCIMH 2017 in Berlin. Our hope is that this document will provide an important impetus for further engagement world-wide after the Congress has concluded. Immediately before the start of WCIMH 2017 on Wednesday May 3rd 2017 there will be several high-quality pre-conference workshops covering all congress topics. Reflecting the political situation in recent years, especially in Europe, we have arranged for a unique half-day workshop on the topic: “Refugees with Chronic Diseases between the Middle-East and Europe: The Role of Traditional and Integrative Medicine in Bridging Gaps”, The speakers are all from the Middle East and Europe and will address how Integrative Medicine may serve as an important element to overcome the problematic health situation of refugees around the world. We are convinced that the field of Complementary and Integrative Medicine, including traditional healing systems and medicine and the arts, will benefit from The 2017 World Congress on Integrative Medicine & Health—a preeminent scientific international forum that is focused on highlighting advances in these thematic areas. We invite all practitioners, educators and researchers in the field of Integrative Medicine to come together, participate and engage together to make this Congress an exciting meeting for the successful advancement of Integrative Medicine across the globe.

Background: Experimental and epidemiologic data suggest that higher circulating prolactin is associated with breast cancer risk; however, how various risk factors for breast cancer influence prolactin levels in healthy women is not clear. Methods: We analyzed cross-sectional associations between several suggested reproductive and lifestyle risk factors for breast cancer and circulating prolactin among pre- and postmenopausal women, taking into account the use of current postmenopausal hormone therapy, among 2,560 controls from a breast cancer nested case–control study within the EPIC cohort. Results: Adjusted geometric mean prolactin levels were significantly higher among premenopausal women, and among postmenopausal women using hormone therapy compared with nonusers (8.2, 7.0, and 6.3 ng/mL, respectively; Pcat = Conclusions: Our study shows that current hormone therapy use, especially the use of combined hormone therapy, is associated with higher circulating prolactin levels in postmenopausal women, and confirms prior findings of lower circulating prolactin in parous women. Impact: Our study extends the knowledge linking various breast cancer risk factors with circulating prolactin. Cancer Epidemiol Biomarkers Prev; 23(11); 2532–42. ©2014 AACR.

An organized mammography screening program was gradually implemented in Norway during the period 1996-2004. Norwegian authorities have initiated an evaluation of the program. Our study focused on breast cancer mortality. Using Poisson regression, we compared the change in breast cancer mortality from before to during screening in four counties starting the program early controlling for change in breast cancer mortality during the same time in counties starting the program late. A follow-up model included death in all breast cancers diagnosed during the follow-up period. An evaluation model included only breast cancers diagnosed in ages where screening was offered. The study group had been invited for screening one to three times and followed for on average of 5.9 years. In the follow-up model, 314 breast cancer deaths were observed in the study group, and 523, 404 and 638, respectively, in the four control groups. The ratio between the changes in breast cancer mortality between early and late starting counties was 0.93 (95% confidence interval [CI] 0.77-1.12). In the evaluation model, this ratio was 0.89 (95% CI: 0.71-1.12). In Norway, where 40% of women used regular mammography prior to the program, the implementation of the organized mammography screening program was associated with a statistically nonsignificant decrease in breast cancer mortality of around 11%.

Background. In Norway, an organized screening mammography program, the Norwegian Breast Cancer Screening Program (NBCSP) started in four counties in 1996 and became nationwide in 2004. We collected data on pre-program screening activity, and in view of this activity we evaluated the potential impact of the program on breast cancer mortality in Norway. Methods. We searched data sources on mammography activity in Norway. Three data sources reported on examination activity, and two on self-reported examinations. We aimed at calculating annual number of women examined by mammography from 1983 to 2008, and coverage rate in program and non-program Norwegian counties. Results. The annual number of women examined increased from 5000 in 1983 to 110 000 in 1993 to reach its maximum of 131 000 in 2002, excluding program examinations. The annual number of women examined in the organized program increased from 1996 to a steady state about 190 000 in 2004. Prior to start of the organized program, 40% of women in target age groups reported to have had mammography examination. During the years 1996 – 2002, 64% of fiparticipants in the organized program reported to have been examined previously. Assuming that the Norwegian program would in absence of prior screening have decreased breast cancer mortality by 25%, and that the activity in- and outside the organized program were equally effective, the measured effect of the organized program would under actual circumstances be a reduction of 11%. Conclusion. The example of Norway illustrates that although monitoring of screening outcome is highly warranted, this may be seriously jeopardized if use of mammography examinations was widespread prior to implementation of an organized program.

To examine patterns of use of hormone therapy (HT), including duration of use, in North Norway in 1996, 2002 and 2005.Within the NOWAC cohort we conducted a cross-sectional comparison of questionnaire data among women aged 48-62 years in 1996 (N=8822), 2002 (N=6262) and 2005 (N=4830). Response rates for first time respondents: 58% in 1996 and 66% in 2005. The 2002 participants were second time respondents including 4814 of the 1996 participants. The partial dependence was managed statistically using generalized estimating equations (GEE) and linear mixed models.Use of HT increased from 1996 (30.5% current, 43.3% ever) to 2002 (38.2% current, 59.3% ever), and decreased toward 2005 (14.7% current, 35.8% ever). High-dose combinations were still the most used HT products in 2005, although low-dose estrogen products and tibolone had gained market shares. Current use of HT among pre-/perimenopausal women was 9.4% in 1996, 13.2% in 2002 and 0.6% in 2005. Mean duration of current HT use was 3.7 years in 1996, 5.8 years in 2002 and 6.3 years in 2005 (p0.05). In 2005 current HT use was not associated with formerly known predictors, except age and menopausal status.Succeeding high levels of HT use in 2002, the prevalence in 2005 is below that in 1996, in accordance with national policies. In 2005 climacteric complaints seems to be the only predictor of HT use. Extensive long-term use in 2005 raises questions regarding compliance with treatment recommendations.

Purpose: This study investigates the validity, reliability, and detection limit of a visual examination method utilizing the Tyndall effect to enhance visible detection of particles. The suitability of the method for compatibility testing of intravenous fluids in a hospital pharmacy context is discussed. Methods: A panel of 20 inspectors examined 20 samples, with and without particles, using two light sources (halogen lightbulb in a focused desk lamp and a red pocket laser pointer). The samples contained particles of different origin (precipitate, polystyrene standards), varying size, and concentrations. Light obscuration and turbidimetric measurements were used to obtain numeric references. The samples were divided into rejection probability zones, and the validity (sensitivity, specificity, and likelihood ratios) and reliability (inter-rater agreement coefficients Fleiss9 kappa and Gwet9s AC1) were estimated. Results: The sensitivity of the laser pointer for detecting microprecipitates was quite high; however, it also showed a high false rejection rate. The specificity was slightly higher for the focused desk lamp than the laser pointer. The likelihood ratios were not within the recommended limits of a useful test, indicating that the method could not securely confirm the presence/absence of particles in the samples. The inter-rater agreement coefficients indicated fair to moderate agreement between the inspectors. Conclusions: The validity and reliability were not satisfactory for either of the light sources. The visual detection limit seemed to be around 5 μm, although we propose that an exact detection limit is not that relevant for compatibility testing. Based on the current findings, the visual examination method cannot be recommended as the sole method for judging compatibility of parenteral nutrition and drugs, but rather in a program of several methods. In the hospital pharmacy, the method may be a resource, together with theoretical considerations, in situations where other methods are unavailable; however, use of in-line-filters is essential to protect the patient. LAY ABSTRACT: Many patients under intensive care are in need of several intravenous drugs simultaneously. These drugs cannot be given in the same infusion line unless compatibility has been documented. Incompatibilities can result in, for example, precipitation of particles. Injected particles can harm the patient and should be avoided. Visual screening of blends of drugs for possible incompatibility, using a focused light source to enhance visual detection based on the Tyndall effect, could be a quick and easy methodology to identify incompatibility. In the following study the objective was to investigate how reliable visual inspection, with the utilization of the Tyndall effect, is at detecting particles and precipitations in blends of intravenous drugs and parenteral nutrition mixtures. Twenty inspectors each examined 20 different samples with two different light sources. Some of the samples were without particles (clean), and some contained different types and degrees of particle contamination. The inspectors9 judgment of the samples was recorded and validity and reliability parameters were calculated to evaluate the method9s suitability. The conclusion was that because of false positive and negative findings the visual inspection method alone is not enough to securely document compatibility/incompatibility, but it is more suitable as support together with additional methods.

Background There is increasing ambiguity towards national mammographic screening programs due to varying publicized estimates of overdiagnosis, i.e., breast cancer that would not have been diagnosed in the women’s lifetime outside screening. This analysis compares the cumulative incidence of breast cancer in screened and unscreened women in Norway from the start of the fully implemented Norwegian Breast Cancer Screening Program (NBCSP) in 2005. Methods Subjects were 53 363 women in the Norwegian Women and Cancer (NOWAC) study, aged 52–79 years, with follow-up through 2010. Mammogram and breast cancer risk factor information were taken from the most recent questionnaire (2002–07) before the start of individual follow-up. The analysis differentiated screening into incidence (52–69 years) and post screening (70–79 years). Relative risks (RR) were estimated by Poisson regression. Results The analysis failed to detect a significantly increased cumulative incidence rate in screened versus other women 52–79 years. RR of breast cancer among women outside the NBCSP, the “control group”, was non-significantly reduced by 7% (RR = 0∙93; 95% confidence interval 0∙79 to 1∙10) compared to those in the program. The RR was attenuated when adjusted for risk factors; RRadj = 0∙97 (0∙82 to 1∙15). The control group consisted of two subpopulations, those who only had a mammogram outside the program (RRadj =1∙04; 0∙86 to 1∙26) and those who never had a mammogram (RRadj = 0∙77; 0∙59 to 1∙01). These groups differed significantly with respect to risk factors for breast cancer, partly as a consequence of the prescription rules for hormone therapy which indicate a mammogram. Conclusions In the fully implemented NBCSP, no significant difference was found in cumulative incidence rates of breast cancer between NOWAC women screened and not screened. Naïve comparisons of screened and unscreened women may be affected by important differences in risk factors. The current challenge for the screening program is to improve the diagnostics used at prevalence screenings (ages 50–51).

Perfluoroalkyl acids (PFAAs) are ubiquitously present in human blood samples and the effects of these compounds on human health are not fully characterized. This study was conducted in order to investigate the applicability of peripheral blood gene expressions for exploring the impact of perfluorooctane sulfonate (PFOS), perfluorooctanoate (PFOA) and perfluorohexane sulfonate (PFHxS) exposure on the general population. PFOS, PFOA and PFHxS were analyzed in blood samples from a representative group of 270 healthy, postmenopausal Norwegian women (48-62 years). Gene expression was measured in the same samples using the Applied Biosystems microarray platform. Forty-eight different gene sets, all previously linked to PFAA exposure were explored in relation to the selected PFAAs. Two gene sets, both related to the citric acid cycle, were differentially expressed between the “PFOS high” (>30ng/ml, n=42) and the “PFOS low” (

Background Postmenopausal hormone therapy (HT) influences endogenous hormone concentrations and increases the risk of breast cancer. Gene expression profiling may reveal the mechanisms behind this relationship. Our objective was to explore potential associations between sex hormones and gene expression in whole blood from a population-based, random sample of postmenopausal women Methods Gene expression, as measured by the Applied Biosystems microarray platform, was compared between hormone therapy (HT) users and non-users and between high and low hormone plasma concentrations using both gene-wise analysis and gene set analysis. Gene sets found to be associated with HT use were further analysed for enrichment in functional clusters and network predictions. The gene expression matrix included 285 samples and 16185 probes and was adjusted for significant technical variables. Results Gene-wise analysis revealed several genes significantly associated with different types of HT use. The functional cluster analyses provided limited information on these genes. Gene set analysis revealed 22 gene sets that were enriched between high and low estradiol concentration (HT-users excluded). Among these were seven oestrogen related gene sets, including our gene list associated with systemic estradiol use, which thereby represents a novel oestrogen signature. Seven gene sets were related to immune response. Among the 15 gene sets enriched for progesterone, 11 overlapped with estradiol. No significant gene expression patterns were found for testosterone, follicle stimulating hormone (FSH) or sex hormone binding globulin (SHBG). Conclusions Distinct gene expression patterns associated with sex hormones are detectable in a random group of postmenopausal women, as demonstrated by the finding of a novel oestrogen signature.

Menopausal hormone therapy (MHT) is characterized by use of different constituents, regimens and routes of administration. We investigated the association between the use of different types of MHT and breast cancer risk in the EPIC cohort study. The analysis is based on data from 133,744 postmenopausal women. Approximately 133,744 postmenopausal women contributed to this analysis. Information on MHT was derived from country-specific self-administered questionnaires with a single baseline assessment. Incident breast cancers were identified through population cancer registries or by active follow-up (mean: 8.6 yr). Overall relative risks (RR) and 95% confidence interval (CI) were derived from country-specific Cox proportional hazard models estimates. A total of 4312 primary breast cancers were diagnosed during 1,153,747 person-years of follow-up. Compared with MHT never users, breast cancer risk was higher among current users of estrogen only (RR: 1.42, 95% CI 1.23-1.64) and higher still among current users of combined MHT (RR: 1.77, 95% CI 1.40-2.24; p = 0.02 for combined vs. estrogen-only). Continuous combined regimens conferred a 43% (95% CI: 19-72%) greater risk compared with sequential regimens. There was no significant difference between progesterone and testosterone derivatives in sequential regimens. There was no significant variation in risk linked to the estrogenic component of MHT, neither for oral vs. cutaneous administration nor for estradiol compounds vs. conjugated equine estrogens. Estrogen-only and combined MHT uses were associated with increased breast cancer risk. Continuous combined preparations were associated with the highest risk. Further studies are needed to disentangle the effects of the regimen and the progestin component.

To assess how postmenopausal women with severe vasomotor symptoms who volunteer for an acupuncture trial (ACUFLASH) differ from the general population (the Norwegian Women and Cancer study, NOWAC); and to describe the use of dietary supplements and medication during trial intervention and follow-up.Questionnaire data on postmenopausal women regarding demography and use of dietary supplements and medication were compared between the ACUFLASH trial (baseline, 2006-2007, n = 267) and the NOWAC study (2004-2005, n = 331). Additionally, the trial intervention groups, acupuncture and self-care (n = 134) or self-care alone (n = 133), were compared regarding supplements and medication use.The prevalence of dietary supplement use was higher among women with severe vasomotor symptoms (83.9%) than in the population-based sample (74.3%), with particularly extensive use of cod liver oil. The prevalence of medication use was 46.4% in ACUFLASH and 55.0% in NOWAC. Trial participants reported poorer self-reported health, higher education level and tended to be former oral contraceptive users and smokers. At trial baseline, 48.5% of the acupuncture group and 60.3% of the self-care group used dietary supplements (p 0.05), while 48.5% in the acupuncture group and 45.0% in the self-care group used medication (p 0.05). Use of supplements for vasomotor symptoms increased significantly in the self-care group at 12 weeks, while it remained unchanged in the acupuncture group. Hormone therapy use increased significantly in both groups after intervention.Postmenopausal women suffering severe vasomotor symptoms used more dietary supplements than the general population. They also had poorer self-reported health, but their medication use was similar to that of the general population. Acupuncture did not influence use of dietary supplements in the randomized intervention.

Objectives: To describe the intake of vitamins thiamine (B1), riboflavin (B2), B6 (pyridoxine), B12 (cobalamine) and C (ascorbic acid) and their food sources among 27 centres in 10 countries participating in the European Prospective Investigation into Cancer and Nutrition (EPIC) study. Methods: Between 1995 and 2000, 36 034 persons aged between 35 and 74 years were administered a standardized 24-h dietary recall using a computerized interview software programme (EPIC-SOFT). Intakes of the four B vitamins and vitamin C were estimated using the standardized EPIC Nutrient Database (ENDB). Mean intakes were adjusted for age and weighted by season and day of recall. Results: Intake of B vitamins did not vary considerably between centres, except in the UK health-conscious cohort, in which substantially higher intakes of thiamine and lower intakes of vitamin B12 were reported compared with other centres. Overall, meat was the most important contributor to the B vitamins in all centres except in the UK health-conscious group. Vitamin C showed a clear geographical gradient, with higher intakes in the southern centres as compared with the northern ones; this was more pronounced in men than in women. Vegetables and fruits were major contributors to vitamin C in all centres, but juices and potatoes were also important sources in the northern centres. Conclusions: This study showed no major differences across centres in the mean intakes of B vitamins (thiamine, riboflavin, B6, B12), whereas a tendency towards a north-south gradient was observed for vitamin C. European Journal of Clinical Nutrition (2009) 63, S122-S149; doi: 10.1038/ejcn.2009.78

Objectives: To describe the intake of the fat-soluble nutrients retinol, beta-carotene, vitamin E and vitamin D and their food sources among 27 redefined centres in 10 countries participating in the European Prospective Investigation into Cancer and Nutrition (EPIC) study. Methods: Between 1995 and 2000, 36 034 subjects (age range: 35-74 years) completed a single standardized 24-h dietary recall using a computerized interview software program (EPIC-SOFT). Intakes of the fat-soluble nutrients were estimated using the standardized EPIC Nutrient Database. Results: For all the nutrients, in most centres, men had a higher level of intake than did women, even after adjustments for total energy intake and anthropometric confounders. Distinct regional gradients from northern to southern European countries were observed for all nutrients. The level intake of beta-carotene and vitamin E also showed some differences by level of education, smoking status and physical activity. No meaningful differences in the nutrient intake were observed by age range. Conclusions: These results show differences by study centre, gender, age and various lifestyle variables in the intake of retinol, beta-carotene, vitamin E and vitamin D between 10 European countries. European Journal of Clinical Nutrition (2009) 63, S150-S178; doi: 10.1038/ejcn.2009.79

Background Hormone replacement therapy use (HRT) is associated with increased breast cancer risk. Our primary objective was to explore hormone levels in plasma according to HRT use, body mass index (BMI) and menopausal status. A secondary objective was to validate self-reported questionnaire information on menstruation and HRT use in the Norwegian Women and Cancer postgenome cohort (NOWAC). Methods We conducted a cross-sectional study of sex hormone levels among 445 women aged 48–62 who answered an eight-page questionnaire in 2004 and agreed to donate a blood sample. The samples were drawn at the women's local general physician's offices in the spring of 2005 and sent by mail to NOWAC, Tromsø, together with a two-page questionnaire. Plasma levels of sex hormones and Sex Hormone Binding Globulin (SHBG) were measured by immunometry. 20 samples were excluded, leaving 425 hormone measurements. Results 20% of postmenopausal women were HRT users. The plasma levels of estradiol (E2) increased with an increased E2 dose, and use of systemic E2-containing HRT suppressed the level of Follicle Stimulating Hormone (FSH). SHBG levels increased mainly among users of oral E2 preparations. Vaginal E2 application did not influence hormone levels. There was no difference in BMI between HRT users and non-users. Increased BMI was associated with increased E2 and decreased FSH and SHBG levels among non-users. Menopausal status defined by the two-page questionnaire showed 92% sensitivity (95% CI 89–96%) and 73% specificity (95% CI 64–82%), while the eight-page questionnaire showed 88% sensitivity (95% CI 84–92%) and 87% specificity (95% CI 80–94%). Current HRT use showed 100% specificity and 88% of the HRT-users had plasma E2 levels above the 95% CI of non-users. Conclusion Users of systemic E2-containing HRT preparations have plasma E2 and FSH levels comparable to premenopausal women. BMI has an influence on hormone levels among non-users. NOWAC questionnaires provide valid information on current HRT use and menopausal status among Norwegian women who are between 48 and 62 years old.

to quantify sales of authorized natural remedies (ANRs) in Norway, to compare the Norwegian authorization scheme with similar schemes in Sweden, Denmark and the EU, and to identify factors influencing the number of marketed ANRs.descriptive statistics are used to present sales of ANRs in Norway. The ANRs are classified by indication group and assigned a recommended daily dose (RDD) according to the posology section in the Summary of Product Characteristics (SPC). Document analysis of regulation and general information concerning natural remedies is used to compare the authorization schemes for ANRs in Scandinavia and for traditional herbal medicinal products (THMs) in the EU. Four cases of herbs are described to illustrate the consequences of this regulation and identify possible influencing factors.sales, in terms of both mean consumer prices and number of RDDs, and the factors found to influence the number of marketed ANRs.total sales of ANRs in Norway in 2003 wereeuro1.5 per capita (3% of the food supplement market), or 5.5 RDD/1,000/day, and the sales have tended to decline. Norway has very few ANRs compared with Sweden and Denmark. Changes in Norwegian ANR regulation in 2004 have harmonized application requirements in Scandinavia, but results have yet to be seen. THMs are subject to the same quality requirements as ANRs, and will replace the ANRs over the next 7 years. Several factors have influenced the manufacturers' application incentive, e.g., application costs, differentiated VAT rates, consumer knowledge and surveillance by health authorities.sales of authorized compared to unauthorized natural remedies in Norway are very low and the ANRs are in a weak position compared to Denmark and Sweden. Surveillance by health authorities and increased consumer knowledge of ANRs is probably more stimulating with respect to application incentive than lower application costs. Introducing THMs will hopefully increase the number of quality-controlled products on the Scandinavian market.