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Clinical Epidemiology

María Barroso, Silvia Pérez-Fernández, M Mar Vila, M Dolors Zomeño, Ruth Martí-Lluch, Ferran Cordon, Rafel Ramos, Roberto Elosua, Irene R Degano, Montse Fitó, Carmen Cabezas, Gemma Salvador, Conxa Castell, María Grau
Background: The validity of a cardiovascular risk self-screening method was assessed. The results obtained for self-measurement of blood pressure, a point-of-care system's assessment of lipid profile and glycated hemoglobin, and a self-administered questionnaire (sex, age, diabetes, tobacco consumption) were compared with the standard screening (gold standard) conducted by a health professional. Methods: Crossover clinical trial on a population-based sample from Girona (north-eastern Spain), aged 35-74, with no cardiovascular disease at recruitment...
2018: Clinical Epidemiology
Trude Eid Robsahm, Per Helsing, Yngvar Nilssen, Linda Vos, Syed Mohammad H Rizvi, Lars A Akslen, Marit B Veierød
Purpose: The purpose of this study was to examine why Norway has the highest rate of mortality due to cutaneous melanoma (CM) in Europe. The Norwegian Malignant Melanoma Registry (NMMR) enables the study of clinical and histopathological characteristics of patients who die due to CM. Results: The NMMR and the Norwegian Cause of Death Registry provided data on the clinical and histopathological factors as well as the date and cause of death, through June 2015 for all first invasive CMs diagnosed in 2008-2012 (n=8087)...
2018: Clinical Epidemiology
Andreas Stang, Christopher Baethge
Background: Results of randomized controlled trials (RCTs) are usually accompanied by a table that compares covariates between the study groups at baseline. Sometimes, the investigators report p values for imbalanced covariates. The aim of this debate is to illustrate the pro and contra of the use of these p values in RCTs. Pro: Low p values can be a sign of biased or fraudulent randomization and can be used as a warning sign. They can be considered as a screening tool with low positive-predictive value...
2018: Clinical Epidemiology
Kasper Adelborg, Jens Sundbøll, Morten Schmidt, Hans Erik Bøtker, Noel S Weiss, Lars Pedersen, Henrik Toft Sørensen
Background: Histamine H2 receptor activation promotes cardiac fibrosis and apoptosis in mice. However, the potential effectiveness of histamine H2 receptor antagonists (H2RAs) in humans with heart failure is largely unknown. We examined the association between H2RA initiation and all-cause mortality among patients with heart failure. Methods: Using Danish medical registries, we conducted a nationwide population-based active-comparator cohort study of new users of H2RAs and proton pump inhibitors (PPIs) after first-time hospitalization for heart failure during the period 1995-2014...
2018: Clinical Epidemiology
Daniel G Whitney, Edward A Hurvitz, Jennifer M Ryan, Maureen J Devlin, Michelle S Caird, Zachary P French, Elie C Ellenberg, Mark D Peterson
Purpose: Individuals with cerebral palsy (CP) are at increased risk for frailty and chronic disease due to factors experienced throughout the lifespan, such as excessive sedentary behaviors and malnutrition. However, little is known about noncommunicable diseases (NCDs) and multimorbidity profiles in young adults with CP. The study objective was to compare NCD and multimorbidity profiles between young adults with and without CP. Methods: A clinic-based sample of adults (18-30 years) with (n=452) and without (n=448) CP was examined at the University of Michigan Medical Center...
2018: Clinical Epidemiology
Jonas Hoffmann, Burkhard Haastert, Manuela Brüne, Matthias Kaltheuner, Alexander Begun, Nadja Chernyak, Andrea Icks
Aims: Patients with diabetes are probably often unaware of their comorbidities. We estimated agreement between self-reported comorbidities and administrative data. Methods: In a random sample of 464 diabetes patients, data from a questionnaire asking about the presence of 14 comorbidities closely related to diabetes were individually linked with statutory health insurance data. Results: Specificities were >97%, except cardiac insufficiency (94...
2018: Clinical Epidemiology
Christine Chen, Wen-Chung Lee
Characterizing the relations between exposures and diseases is the central tenet of epidemiology. Researchers may want to evaluate exposure-disease causation by assessing whether the disease under concern is induced by the various exposures - the so-called "attribution". In this paper, the authors propose a method to attribute diseases to multiple pathways based on the causal-pie model. The method can also be used to evaluate the potential impact of an intervention strategy and to allocate responsibility in tort-law liability issues...
2018: Clinical Epidemiology
Heiner Claessen, Maria Narres, Burkhard Haastert, Werner Arend, Falk Hoffmann, Stephan Morbach, Gerhard Rümenapf, Tatjana Kvitkina, Heiko Friedel, Christian Günster, Ingrid Schubert, Walter Ullrich, Benjamin Westerhoff, Adrian Wilk, Andrea Icks
Background and purpose: Lower-extremity amputations (LEAs) in people with diabetes are associated with reduced quality of life and increased health care costs. Detailed knowledge on amputation rates (ARs) is of utmost importance for future health care and economics strategies. We conducted the present cohort study in order to estimate the incidences of LEA as well as relative and attributable risk due to diabetes and to investigate time trends for the period 2008-2012. Methods: On the basis of the administrative data from three large branches of German statutory health insurers, covering ~34 million insured people nationwide (about 40% of the German population), we estimated age-sex-standardized AR (first amputation per year) in the populations with and without diabetes for any, major, and minor LEAs...
2018: Clinical Epidemiology
Jenna Wong, Michal Abrahamowicz, David L Buckeridge, Robyn Tamblyn
Objective: Physicians commonly prescribe antidepressants for indications other than depression that are not evidence-based and need further evaluation. However, lack of routinely documented treatment indications for medications in administrative and medical databases creates a major barrier to evaluating antidepressant use for indications besides depression. Thus, the aim of this study was to derive a model to predict when primary care physicians prescribe antidepressants for indications other than depression and to identify important determinants of this prescribing practice...
2018: Clinical Epidemiology
Thomas Bøjer Rasmussen, Sinna Pilgaard Ulrichsen, Mette Nørgaard
Background: Monitoring hospital outcomes and clinical processes as a measure of clinical performance is an integral part of modern health care. The risk-adjusted cumulative sum (CUSUM) chart is a frequently used sequential analysis technique that can be implemented to monitor a wide range of different types of outcomes. Objective: The aim of this study was to describe how risk-adjusted CUSUM charts based on population-based nationwide medical registers were used to monitor 30-day mortality in Danish hospitals and to give an example on how alarms of increased hospital mortality from the charts can guide further in-depth analyses...
2018: Clinical Epidemiology
Mihai Dorin Vartolomei, Shoji Kimura, Matteo Ferro, Beat Foerster, Mohammad Abufaraj, Alberto Briganti, Pierre I Karakiewicz, Shahrokh F Shariat
Objective: To investigate the impact of moderate wine consumption on the risk of prostate cancer (PCa). We focused on the differential effect of moderate consumption of red versus white wine. Design: This study was a meta-analysis that includes data from case-control and cohort studies. Materials and methods: A systematic search of Web of Science, Medline/PubMed, and Cochrane library was performed on December 1, 2017. Studies were deemed eligible if they assessed the risk of PCa due to red, white, or any wine using multivariable logistic regression analysis...
2018: Clinical Epidemiology
Masao Iwagami, Kathryn E Mansfield, Joseph F Hayes, Kate Walters, David Pj Osborn, Liam Smeeth, Dorothea Nitsch, Laurie A Tomlinson
Objective: We investigated the burden of chronic kidney disease (CKD) among patients with severe mental illness (SMI). Methods: We identified patients with SMI among all those aged 25-74 registered in the UK Clinical Practice Research Datalink as on March 31, 2014. We compared the prevalence of CKD (two measurements of estimated glomerular filtration rate <60 mL/min/1.73 m2 for ≥3 months) and renal replacement therapy between patients with and without SMI. For patients with and without a history of lithium prescription separately, we used logistic regression to examine the association between SMI and CKD, adjusting for demographics, lifestyle characteristics, and known CKD risk factors...
2018: Clinical Epidemiology
Edouard Chatignoux, Amélie Gabet, Elodie Moutengou, Philippe Pirard, Yvon Motreff, Christophe Bonaldi, Valérie Olié
Background: The terrorist attacks in Paris and Nice in 2015 and 2016 generated widespread emotional stress in France. Given that acute emotional stress is a well-known trigger for cardiovascular disease, we investigated whether these attacks had any short-term impact on hospitalizations for acute cardiovascular disease in France. Methods: Annual hospital discharge data from 2009 to 2016 were extracted from the French Hospital Discharge Database. All hospitalizations with a primary diagnosis of acute coronary syndrome, heart failure, or stroke were selected...
2018: Clinical Epidemiology
Rutger A Middelburg, Jean-Louis H Kerkhoffs, Johanna G van der Bom
Background: Hematology-oncology patients often become severely thrombocytopenic and receive prophylactic platelet transfusions when their platelet count drops below 10×109 platelets/L. This so-called "platelet count trigger" of 10×109 platelets/L is recommended because currently available evidence suggests this is the critical concentration at which bleeding risk starts to increase. Yet, exposure time and lag time may have biased the results of studies on the association between platelet counts and bleeding risks...
2018: Clinical Epidemiology
Magnus Spangsberg Boesen, Melinda Magyari, Alfred Peter Born, Lau Caspar Thygesen
Objective: To validate the Danish National Patient Register's (NPR) diagnoses of pediatric acquired demyelinating syndromes (ADS) including multiple sclerosis (MS). Study design and setting: We identified ADS diagnostic groups using International Classification of Diseases (ICD) codes and reviewed medical records to validate the NPR diagnoses during 2008-2015. Results: Among 409 children in the study, 184 children had a validated and final ADS diagnosis after reviewing medical records as follows: optic neuritis (ON; n=46), transverse myelitis (TM; n=16), acute disseminated encephalomyelitis (ADEM; n=50), clinically isolated syndrome (CIS) including dissemination in space (CIS [DIS]) but not dissemination in time (n=6), neuromyelitis optica spectrum disorder (NMOsd; n=5), and MS (n=61)...
2018: Clinical Epidemiology
Hermann Brenner, Jing Qian, Simone Werner
Objective: Fecal immunochemical tests (FITs) for hemoglobin in stool are increasingly used for colorectal cancer screening. Reported sensitivities and specificities have strongly varied between studies, but it is unclear to what extent such variation reflects differences between tests or between study population characteristics. We aimed to evaluate the key parameters of FIT performance for detecting advanced neoplasia (AN) according to sex and age. Methods: Sex- and age-specific sensitivity, specificity, positive predictive values (PPVs) and negative predictive values (NPVs) for detecting AN of a quantitative FIT (FOB Gold®) were evaluated among 3211 men and women aged 50-79 years who underwent screening colonoscopy in Germany...
2018: Clinical Epidemiology
Lisa Sm Eurelings, Jan Willem van Dalen, Gerben Ter Riet, Eric P Moll van Charante, Edo Richard, Willem A van Gool
Background: Previous findings suggest that apathy symptoms independently of depressive symptoms measured using the Geriatric Depression Scale (GDS) are associated with cardiovascular disease (CVD) in older individuals. Aims: To study whether apathy and depressive symptoms in older people are associated with future CVD, stroke, and mortality using individual patient-data meta-analysis. Methods: Medline, Embase, and PsycInfo databases up to September 3, 2013, were systematically searched without language restrictions...
2018: Clinical Epidemiology
Loan R van Hoeven, Aukje L Kreuger, Kit Cb Roes, Peter F Kemper, Hendrik Koffijberg, Floris J Kranenburg, Jan Mm Rondeel, Mart P Janssen
Background: To enhance the utility of transfusion data for research, ideally every transfusion should be linked to a primary clinical indication. In electronic patient records, many diagnostic and procedural codes are registered, but unfortunately, it is usually not specified which one is the reason for transfusion. Therefore, a method is needed to determine the most likely indication for transfusion in an automated way. Study design and methods: An algorithm to identify the most likely transfusion indication was developed and evaluated against a gold standard based on the review of medical records for 234 cases by 2 experts...
2018: Clinical Epidemiology
Jay Jh Park, Kristian Thorlund, Edward J Mills
Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules...
2018: Clinical Epidemiology
Ruben Pa van Eijk, Marinus Jc Eijkemans, Dimitris Rizopoulos, Leonard H van den Berg, Stavros Nikolakopoulos
Objective: Amyotrophic lateral sclerosis (ALS) clinical trials based on single end points only partially capture the full treatment effect when both function and mortality are affected, and may falsely dismiss efficacious drugs as futile. We aimed to investigate the statistical properties of several strategies for the simultaneous analysis of function and mortality in ALS clinical trials. Methods: Based on the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database, we simulated longitudinal patterns of functional decline, defined by the revised amyotrophic lateral sclerosis functional rating scale (ALSFRS-R) and conditional survival time...
2018: Clinical Epidemiology
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