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Journal of Clinical Epidemiology

Iris L Maas, Sandra Nolte, Otto B Walter, Thomas Berger, Martin Hautzinger, Fritz Hohagen, Wolfgang Lutz, Björn Meyer, Johanna Schröder, Christina Späth, Jan Philipp Klein, Steffen Moritz, Matthias Rose
OBJECTIVE: To compare treatment effect estimates obtained from a Regression Discontinuity (RD) design with results from an actual randomized controlled trial (RCT). STUDY DESIGN AND SETTING: Data from an RCT (EVIDENT), which studied the effect of an internet intervention on depressive symptoms measured with the Patient Health Questionnaire (PHQ-9), were used to perform an RD analysis, in which treatment allocation was determined by a cut-off value at baseline (PHQ-9=10)...
November 16, 2016: Journal of Clinical Epidemiology
Lee Aymar Ndounga Diakou, Francine Ntoumi, Philippe Ravaud, Isabelle Boutron
BACKGROUND: In light of funding constraints in Sub-Saharan Africa (SSA), the value of research performed there must be increased. OBJECTIVE: To describe the epidemiology of published RCTs performed in SSA. METHODS: We searched PubMed, the Cochrane library and African Index Medicus to identify reports of all RCTs performed in SSA and published between January 1, 2014 and March 31, 2015. We systematically recorded the country of the affiliation of the corresponding author and the funding source...
November 16, 2016: Journal of Clinical Epidemiology
Philipp Storz-Pfennig
OBJECTIVE: The objective was to estimate the presence and extent to which potentially unnecessary and therefore maybe wasteful clinical trials regarding relevant interventions and outcomes in major clinical areas had been conducted. STUDY DESIGN AND METHODS: From current Cochrane collaboration systematic reviews in major medical fields (e.g. CVD, cancer, psychiatry) 13 different comparisons were sampled. A cumulative meta-analysis was conducted for each and trial sequential analysis applied to determine when in the course of evidence accrual evidence was found sufficient to reach a reliable conclusion...
November 16, 2016: Journal of Clinical Epidemiology
Karen A Robinson, Wesley E Davis, Victor D Dinglas, Pedro A Mendez-Tellez, Anahita Rabiee, Vineeth Sukrithan, Ramakrishna Yalamanchilli, Alison E Turnbull, Dale M Needham
BACKGROUND AND OBJECTIVE: There is a growing number of studies evaluating the physical, cognitive, mental health and health-related quality of life (QOL) outcomes of adults surviving critical illness. However, there is little consensus on the most appropriate instruments to measure these outcomes. To inform the development of such consensus, we conducted a systematic review of the performance characteristics of instruments measuring physical, cognitive, mental health and HRQOL outcomes in adult intensive care unit (ICU) survivors...
November 16, 2016: Journal of Clinical Epidemiology
Maria Petropoulou, Adriani Nikolakopoulou, Areti-Angeliki Veroniki, Patricia Rios, Afshin Vafaei, Wasifa Zarin, Myrsini Giannatsi, Shannon Sullivan, Andrea C Tricco, Anna Chaimani, Matthias Egger, Georgia Salanti
OBJECTIVE: To assess the characteristics and core statistical methodology specific to network meta-analyses (NMAs) in clinical research articles. STUDY DESIGN AND SETTING: We searched Medline, Embase and the Cochrane Database of Systematic Reviews from inception until April 14, 2015 for NMAs of randomized controlled trials (RCTs) including at least four different interventions. Two reviewers independently screened potential studies, while data abstraction was performed by a single reviewer and verified by a second...
November 15, 2016: Journal of Clinical Epidemiology
Nicola McCleary, Jill J Francis, Marion K Campbell, Craig R Ramsay, Martin P Eccles, Shaun Treweek, Julia Allan
No abstract text is available yet for this article.
November 15, 2016: Journal of Clinical Epidemiology
Peter Kent, Eleanor Boyle, Jennifer L Keating, Hanne B Albert, Jan Hartvigsen
OBJECTIVE: To quantify variability in the results of statistical analyses based on contingency tables and discuss the implications for the choice of sample size for studies that derive clinical prediction rules. STUDY DESIGN AND SETTING: An analysis of three pre-existing sets of large cohort data (n= 4,062 to 8,674) was performed. In each dataset, repeated random-sampling of various sample sizes, from n=100 up to n=2,000, was performed 100 times at each sample size and the variability in estimates of sensitivity, specificity, positive and negative likelihood ratios, post-test probabilities, odds ratios and risk/prevalence ratios, for each sample size was calculated...
November 12, 2016: Journal of Clinical Epidemiology
Tobias Bluhmki, Peter Bramlage, Michael Volk, Matthias Kaltheuner, Thomas Danne, Wolfgang Rathmann, Jan Beyersmann
OBJECTIVE: Complex longitudinal sampling and the observational structure of patient registers in health services research are associated with methodological challenges regarding data management and statistical evaluation. We exemplify common pitfalls and want to stimulate discussions on the design, development, and deployment of future longitudinal patient registers and register-based studies. STUDY DESIGN AND SETTING: For illustrative purposes, we employ data from the prospective, observational, German DIabetes Versorgungs-Evaluation (DIVE) register...
November 11, 2016: Journal of Clinical Epidemiology
M Hassan Murad, Gordon H Guyatt, Juan Pablo Domecq, Robin W M Vernooij, Patricia J Erwin, Joerg J Meerpohl, Gabriela J Prutsky, Elie A Akl, Katharina Mueller, Dirk Bassler, Stefan Schandelmaier, Stephen D Walter, Jason W Busse, Benjamin Kasenda, Gennaro Pagano, Hector Pardo-Hernandez, Victor M Montori, Zhen Wang, Matthias Briel
OBJECTIVE: We explored how investigators of ongoing or planned trials respond to the publication of a trial stopped early for benefit addressing a similar question. STUDY DESIGN AND SETTING: We searched multiple databases from the date of publication of the truncated trial through August, 2015. Independent reviewers selected trials and extracted data. RESULTS: We identified 207 trials truncated for early benefit; of which 102 (49%) were followed by subsequent trials (262 subsequent trials, median 2 per truncated trial, range 1-13)...
November 7, 2016: Journal of Clinical Epidemiology
Shingai Machingaidze, Babalwa Zani, Amber Abrams, Solange Durao, Quinette Louw, Tamara Kredo, Karen Grimmer, Taryn Young
OBJECTIVES: Clinical Practice Guideline (CPGs) development has evolved over the past decade, with greater emphasis now being placed on transparency, rigour of development, and reporting standards. Our evaluation assesses the quality of the guideline development processes and reporting of selected South African primary care CPGs. STUDY DESIGN: CPGs were iteratively identified by two authors, seeking CPGs reflecting common conditions with which patients present in South African primary care settings...
November 4, 2016: Journal of Clinical Epidemiology
Andrea Icks, Alexandra Dittrich, Manuela Brüne, Oliver Kuss, Annika Hoyer, Burkhard Haastert, Alexander Begun, Silke Andrich, Jonas Hoffmann, Matthias Kaltheuner, Nadja Chernyak
OBJECTIVE: To analyse the impact of different recall lengths on agreement between self-reported physician visits and those documented in health insurance data applying an experimental design. STUDY DESIGN AND SETTING: We randomly assigned 432 patients with diabetes to one of two versions of a written survey, each asking about the number of physician visits over a 3 or 6 month recall period. Health insurance data were linked individually. RESULTS: In both groups, the mean number of self-reported physician visits per month was lower than in the insurance data, with a larger difference in the 6 month group (-0...
November 4, 2016: Journal of Clinical Epidemiology
Carlos Gómez Restrepo, Sergio Muñoz N, Alvaro J Ruiz, Fernando Lanas
The Latin American Clinical Epidemiology Network (LatinCLEN) was born in the nineties as a branch of the International Clinical Epidemiology Network (INCLEN). Clinical Epidemiology Units that made up this network in the region were initially composed of health professionals trained in Australia and North America. From these units, second and third generation training centers started to develop in the region, with the main purpose of introducing clinical research methodology and critical appraisal, as well as health economics and biostatistics...
October 24, 2016: Journal of Clinical Epidemiology
Viet-Thi Tran, Raphael Porcher, Viet-Chi Tran, Philippe Ravaud
OBJECTIVE: Sample size in surveys with open-ended questions relies on the principle of data saturation. Determining the point of data saturation is complex because researchers have information on only what they have found. The decision to stop data collection is solely dictated by the judgment and experience of researchers. In this article, we present how mathematical modeling may be used to describe and extrapolate the accumulation of themes during a study to help researchers determine the point of data saturation...
October 24, 2016: Journal of Clinical Epidemiology
Marc Aerts, Girma Minalu, Stefan Bösner, Frank Buntinx, Bernard Burnand, Jörg Haasenritter, Lilli Herzig, J André Knottnerus, Staffan Nilsson, Walter Renier, Carol Sox, Harold Sox, Norbert Donner-Banzhoff
OBJECTIVE: To construct a clinical prediction rule for coronary artery disease (CAD) presenting with chest pain in primary care. STUDY DESIGN: Meta-Analysis using 3099 patients from 5 studies. To identify candidate predictors, we used random forest trees, multiple imputation of missing values and logistic regression within individual studies. To generate a prediction rule on the pooled data, we applied a regression model that took account of the differing standard data sets collected by the 5 studies...
October 20, 2016: Journal of Clinical Epidemiology
Hoover Quitian-Reyes, Carlos Gómez-Restrepo, Maria Juliana Gómez, Salome Naranjo, Patricia Heredia, John Villegas
OBJECTIVE: This study aimed to quantify the number of years of life lost (YLL) in traffic accidents in Bogota, Colombia. STUDY DESIGN AND SETTING: The years of life lost were calculated using the 'age-standardized expected years of life lost' method, the table of Japanese adjusted life expectancy and the database of the Institute of Legal Medicine and Forensic Science between September 2012 and August 2013. RESULTS: During a period of one year, 430 people died and 10,056...
October 19, 2016: Journal of Clinical Epidemiology
Nicole L De La Mata, Mi-Young Ahn, Nagalingeswaran Kumarasamy, Penh Sun Ly, Oon Tek Ng, Kinh Van Nguyen, Tuti Parwati Merati, Thuy Thanh Pham, Man Po Lee, Nicolas Durier, Matthew G Law
OBJECTIVE: To compare two HIV cohorts to determine whether a pseudo-random sample can represent the entire study population. STUDY DESIGN AND SETTING: HIV-positive patients receiving care at 8 sites in 7 Asian countries. TAHOD pseudo-randomly selected a patient sample, while TAHOD-LITE included all patients. We compared patient demographics, CD4 count and HIV viral load testing for each cohort. Risk factors associated with CD4 count response, HIV viral load suppression (<400 copies/mL) and survival were determined for each cohort...
October 19, 2016: Journal of Clinical Epidemiology
Carlos Gómez-Restrepo, Salomé Naranjo-Lujan, Martín Rondón, Andrés Acosta, Patricia Maldonado, Carlos Arango Villegas, Jaime Hurtado, Juan Carlos Hernández, María Del Pilar Angarita, Marcela Peña, Miguel Ángel Saavedra, Hoover Quitian
OBJECTIVES: In Colombia, some studies have estimated medical costs associated to traffic accidents. It is required to assess results by city or region and determine the influence of variables such as alcohol consumption. The main objective of this study is to identify health care costs associated to traffic accidents in Bogota, and determine whether alcohol consumption can increase them. DESIGN: and settings: Cross sectional costs study conducted in patients over 18 years treated in the emergency rooms of 6 different hospitals in Bogota, Colombia...
October 19, 2016: Journal of Clinical Epidemiology
Robin Nance, Joseph Delaney, John W McEvoy, Michael J Blaha, Gregory Burke, Ana Navas-Acien, Joel D Kaufman, Elizabeth C Oelsner, Robyn L McClelland
OBJECTIVE: Smoking as an epidemiological exposure can be quantified in many ways including duration, intensity, pack-years, recency, and age at initiation. However it is not clear which of these are most important for cardiovascular disease (CVD), and how they should be modeled. STUDY DESIGN AND SETTING: Using the Multi-Ethnic Study of Atherosclerosis, Cox models for time to incident CVD adjusted for age, sex, race/ethnicity, education category, and income category were compared which included various characterizations of smoking history...
October 18, 2016: Journal of Clinical Epidemiology
Fernando Lanas, Pamela Serón, Sergio Muñoz, Paula Margozzini, Teresa Puig
OBJECTIVES: Obesity is an important determinant of cardiovascular risk. However, the optimal measure and cutoffs in Latin America are not defined. We sought to assess the relationship between body mass index (BMI), waist circumference (WC) and waist-to-height ratio (WHtR) with risk factor prevalence and estimated coronary heart disease (CHD) risk and to assess if recommended cutoffs apply to the Chilean population. STUDY DESIGN AND SETTING: Data from 2,200 men and 3,216 women from the Chilean Health Survey 2009-2010 were analyzed...
October 17, 2016: Journal of Clinical Epidemiology
Nathalie Charpak, Juan Gabriel Ruiz
Kangaroo Mother Care (KMC) is a human-based care intervention devised to complement neonatal care for low birth weight and premature infants. Kangaroo position (skin-to-skin contact on the mother's chest) offers thermal regulation, physiological stability, appropriate stimulation and enhances bonding and breastfeeding. Kangaroo nutrition is based on breastfeeding and kangaroo discharge policy relies on family empowerment and early discharge in kangaroo position with close ambulatory follow-up. We describe how the evidence has been developed, and how it has been put into practice by means of direct preterm infants care and dissemination of the method, including training of KMC excellence centers in many countries not only in Latin America but worldwide...
October 17, 2016: Journal of Clinical Epidemiology
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