Association between contemporary hormonal contraception and ovarian cancer in women of reproductive age in Denmark : prospective, nationwide cohort study

Supported by a grant (11645) from the Novo Nordisk Foundation. The funder had no role in the study design; in the collection, analysis and interpretation of data, in the writing of the paper or in the decision to submit the paper for publication.Peer reviewedPublisher PD

Hormonal contraceptive use and risk of pancreatic cancer : A cohort study among premenopausal women

Drs. Mørch and Lidegaard were supported by a grant (No 11645) from the Novo Nordisk Foundation. The funder had no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the paper; or in the decision to submit the paper for publication. Correction: Hormonal contraceptive use and risk of pancreatic cancer—A cohort study among premenopausal women; Sedrah Arif Butt, Øjvind Lidegaard, Charlotte Skovlund, Philip C. Hannaford, Lisa Iversen, Shona Fielding, Lina Steinrud Mørch; PLOS, Published: March 28, 2019, https://doi.org/10.1371/journal.pone.0214771Peer reviewedPublisher PD

Short-form measures of diabetes-related emotional distress: The Problem Areas in Diabetes Scale (PAID)-5 and PAID-1

Aims/hypothesis: We wanted to identify a five-item short form of the Problem Areas in Diabetes Scale and a single-item measure for rapid screening of diabetes-related emotional distress. Methods: Using an existing database of 1,153 patients with diabetes, we conducted a principal-components analysis to identify a set of five items and then conducted a reliability analysis and validity checks. From those five items, we identified the item with the strongest psychometric properties as a one-item screening tool. Results: We identified a reliable and valid short version of the Problem Areas in Diabetes Scale (PAID) comprising five of the emotional-distress questions of the full PAID items (PAID-5, with items 3, 6, 12, 16, 19). The PAID-5 has satisfactory sensitivity (94%) and specificity (89%) for recognition of diabetes-related emotional distress. We also identified a one-item screening tool, the PAID-1 (Question 12: Worrying about the future and the possibility of serious complications), which has concurrent sensitivity and specificity of about 80% for the recognition of diabetes-related emotional distress. Conclusions/ interpretation: The PAID-5 and PAID-1 appear to be psychometrically robust short-form measures of diabetes-related emotional distress.Centro de Endocrinología Experimental y Aplicad

Interleukin-6 and C-reactive protein as prognostic biomarkers in metastatic colorectal cancer

OBJECTIVES: The aim was to explore the prognostic significance of IL-6 and markers of systemic inflammatory response (SIR), in particular C-reactive protein (CRP), in metastatic colorectal cancer (mCRC) patients, in the total study population and according to RAS and BRAF mutation status. RESULTS: High levels of pretreatment serum IL-6 or CRP were associated with impaired outcome, in terms of reduced PFS and OS. Patients with low versus high serum IL-6 levels had median OS of 26.0 versus 16.6 months, respectively (P < 0.001). Stratified according to increasing CRP levels, median OS varied from 24.3 months to 12.3 months, (P < 0.001). IL-6 and CRP levels affected overall prognosis also in adjusted analyses. The effect of IL-6 was particularly pronounced in patients with BRAF mutation (interaction P = 0.004). MATERIALS AND METHODS: IL-6 and CRP were determined in pre-treatment serum samples from 393 patients included in the NORDIC-VII trial, in which patients with mCRC received first line treatment. The effect of serum IL-6 and CRP on progression-free survival (PFS) and overall survival (OS) was estimated. CONCLUSIONS: High baseline serum consentrations of IL-6 or CRP were associated with impaired prognosis in mCRC. IL-6 and CRP give independent prognostic information in addition to RAS and BRAF mutation status

Prevalence and incidence rates of atrial fibrillation in Norway 2004-2014

Objective: To study time trends in incidence of atrial fibrillation (AF) in the entire Norwegian population from 2004 to 2014, by age and sex, and to estimate the prevalence of AF at the end of the study period. Methods: A national cohort of patients with AF (≥18 years) was identified from inpatient admissions with AF and deaths with AF as underlying cause (1994–2014), and AF outpatient visits (2008–2014) in the Cardiovascular Disease in Norway (CVDNOR) project. AF admissions or out-of-hospital death from AF, with no AF admission the previous 10 years defined incident AF. Age-standardised incidence rates (IR) and incidence rate ratios (IRR) were calculated. All AF cases identified through inpatient admissions and outpatient visits and alive as of 31 December 2014 defined AF prevalence. Results: We identified 175 979 incident AF cases (30% primary diagnosis, 69% secondary diagnosis, 0.6% out-of-hospital deaths). AF IRs (95% confidence intervals) per 100 000 person years were stable from 2004 (433 (426–440)) to 2014 (440 (433–447)). IRs were stable or declining across strata of sex and age with the exception of an average yearly increase of 2.4% in 18–44 year-olds: IRR 1.024 (1.014–1.034). In 2014, the prevalence of AF in the adult population was 3.4%. Conclusions: We found overall stable IRs of AF for the adult Norwegian population from 2004 to 2014. The prevalence of AF was 3.4% at the end of 2014, which is higher than reported in previous studies. Signs of an increasing incidence of early-onset AF (<45 years) are worrying and need further investigation.publishedVersio

A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach

AIMS To select a core list of standard outcomes for diabetes to be routinely applied internationally, including patient-reported outcomes. METHODS We conducted a structured systematic review of outcome measures, focusing on adults with either type 1 or type 2 diabetes. This process was followed by a consensus-driven modified Delphi panel, including a multidisciplinary group of academics, health professionals and people with diabetes. External feedback to validate the set of outcome measures was sought from people with diabetes and health professionals. RESULTS The panel identified an essential set of clinical outcomes related to diabetes control, acute events, chronic complications, health service utilisation, and survival that can be measured using routine administrative data and/or clinical records. Three instruments were recommended for annual measurement of patient-reported outcome measures: the WHO Well-Being Index for psychological well-being; the depression module of the Patient Health Questionnaire for depression; and the Problem Areas in Diabetes scale for diabetes distress. A range of factors related to demographic, diagnostic profile, lifestyle, social support and treatment of diabetes were also identified for case-mix adjustment. CONCLUSIONS We recommend the standard set identified in this study for use in routine practice to monitor, benchmark and improve diabetes care. The inclusion of patient-reported outcomes enables people living with diabetes to report directly on their condition in a structured way

Interim analyses of data as they accumulate in laboratory experimentation

BACKGROUND: Techniques for interim analysis, the statistical analysis of results while they are still accumulating, are highly-developed in the setting of clinical trials. But in the setting of laboratory experiments such analyses are usually conducted secretly and with no provisions for the necessary adjustments of the Type I error-rate. DISCUSSION: Laboratory researchers, from ignorance or by design, often analyse their results before the final number of experimental units (humans, animals, tissues or cells) has been reached. If this is done in an uncontrolled fashion, the pejorative term 'peeking' has been applied. A statistical penalty must be exacted. This is because if enough interim analyses are conducted, and if the outcome of the trial is on the borderline between 'significant' and 'not significant', ultimately one of the analyses will result in the magical P = 0.05. I suggest that Armitage's technique of matched-pairs sequential analysis should be considered. The conditions for using this technique are ideal: almost unlimited opportunity for matched pairing, and a short time between commencement of a study and its completion. Both the Type I and Type II error-rates are controlled. And the maximum number of pairs necessary to achieve an outcome, whether P = 0.05 or P > 0.05, can be estimated in advance. SUMMARY: Laboratory investigators, if they are to be honest, must adjust the critical value of P if they analyse their data repeatedly. I suggest they should consider employing matched-pairs sequential analysis in designing their experiments

Short-form measures of diabetes-related emotional distress: The Problem Areas in Diabetes Scale (PAID)-5 and PAID-1

Aims/hypothesis: We wanted to identify a five-item short form of the Problem Areas in Diabetes Scale and a single-item measure for rapid screening of diabetes-related emotional distress. Methods: Using an existing database of 1,153 patients with diabetes, we conducted a principal-components analysis to identify a set of five items and then conducted a reliability analysis and validity checks. From those five items, we identified the item with the strongest psychometric properties as a one-item screening tool. Results: We identified a reliable and valid short version of the Problem Areas in Diabetes Scale (PAID) comprising five of the emotional-distress questions of the full PAID items (PAID-5, with items 3, 6, 12, 16, 19). The PAID-5 has satisfactory sensitivity (94%) and specificity (89%) for recognition of diabetes-related emotional distress. We also identified a one-item screening tool, the PAID-1 (Question 12: Worrying about the future and the possibility of serious complications), which has concurrent sensitivity and specificity of about 80% for the recognition of diabetes-related emotional distress. Conclusions/ interpretation: The PAID-5 and PAID-1 appear to be psychometrically robust short-form measures of diabetes-related emotional distress.Centro de Endocrinología Experimental y Aplicad

ABO phenotypes and malaria related outcomes in mothers and babies in The Gambia: a role for histo-blood groups in placental malaria?

BACKGROUND: Host susceptibility to P.falciparum is critical for understanding malaria in pregnancy, its consequences for the mother and baby, and for improving malaria control in pregnant women. Yet host genetic factors which could influence placental malaria risk are little studied and there are no reports of the role of blood group polymorphisms on pregnancy outcomes in malaria endemic areas. This study analyses the association between ABO blood group phenotypes in relation to placental malaria pathology. METHODS: A total of 198 mother/child pairs delivering in Banjul and the Kombo-St Mary District (The Gambia) were analysed. ABO blood group was measured by agglutination. Placental malaria parasites wee enumerated and the presence of malaria pigment noted. Birth anthropometry was recorded and placental weight. Maternal and infant haemoglobin was measured. RESULTS: 89 (45%) subjects were primiparae and 110 (55%)multiparae. The ABO phenotype distribution was 38(A), 52(B), 6(AB) and 102(O). Placental histo-pathology showed active placental malaria in 74 (37%), past infection in 42 (21%) and no infection in 82 cases (41%). In primiparae blood group O was associated with a higher risk of active infection (OR = 2.99; 95% CI = 1.24–7.25), and a lower risk of past infection (OR = 0.31, 0.10–1.01, p < 0.05). In multiparae the O phenotype was associated with reduced prevalence of active or past placental infection (OR = 0.45; 95% CI 0.21–0.98). The mean feto-placental weight ratio was significantly higher in multiparae with group O women compared to non-O phenotypes (5.74 vs 5.36; p = 0.04). Among primiparae with active placental infection, mean birth weight was higher in children of mothers with the O phenotype (p = 0.04). CONCLUSION: These results indicate that blood group O was significantly associated with increased placental malaria infection in primiparae and reduced risk of infection in multiparae. This parity related susceptibility was not present with other ABO phenotypes. Cell surface glycans, such as ABO and related antigens have special relevance in reproductive biology and could modulate specific cell interactions as those associated with the pathogenesis of placental malaria