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BMC Medical Research Methodology

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https://www.readbyqxmd.com/read/28969588/design-considerations-and-analysis-planning-of-a-phase-2a-proof-of-concept-study-in-rheumatoid-arthritis-in-the-presence-of-possible-non-monotonicity
#1
Feng Liu, Stephen J Walters, Steven A Julious
BACKGROUND: It is important to quantify the dose response for a drug in phase 2a clinical trials so the optimal doses can then be selected for subsequent late phase trials. In a phase 2a clinical trial of new lead drug being developed for the treatment of rheumatoid arthritis (RA), a U-shaped dose response curve was observed. In the light of this result further research was undertaken to design an efficient phase 2a proof of concept (PoC) trial for a follow-on compound using the lessons learnt from the lead compound...
October 2, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28950850/item-response-models-for-the-longitudinal-analysis-of-health-related-quality-of-life-in-cancer-clinical-trials
#2
Antoine Barbieri, Jean Peyhardi, Thierry Conroy, Sophie Gourgou, Christian Lavergne, Caroline Mollevi
BACKGROUND: The use of health-related quality of life (HRQoL) as an endpoint in cancer clinical trials is growing rapidly. Hence, research into the statistical approaches used to analyze HRQoL data is of major importance, and could lead to a better understanding of the impact of treatments on the everyday life and care of patients. Amongst the models that are used for the longitudinal analysis of HRQoL, we focused on the mixed models from item response theory, to directly analyze raw data from questionnaires...
September 26, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28946857/predicting-the-multi-domain-progression-of-parkinson-s-disease-a-bayesian-multivariate-generalized-linear-mixed-effect-model
#3
Ming Wang, Zheng Li, Eun Young Lee, Mechelle M Lewis, Lijun Zhang, Nicholas W Sterling, Daymond Wagner, Paul Eslinger, Guangwei Du, Xuemei Huang
BACKGROUND: It is challenging for current statistical models to predict clinical progression of Parkinson's disease (PD) because of the involvement of multi-domains and longitudinal data. METHODS: Past univariate longitudinal or multivariate analyses from cross-sectional trials have limited power to predict individual outcomes or a single moment. The multivariate generalized linear mixed-effect model (GLMM) under the Bayesian framework was proposed to study multi-domain longitudinal outcomes obtained at baseline, 18-, and 36-month...
September 25, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28927376/systematic-review-of-statistical-approaches-to-quantify-or-correct-for-measurement-error-in-a-continuous-exposure-in-nutritional-epidemiology
#4
Derrick A Bennett, Denise Landry, Julian Little, Cosetta Minelli
BACKGROUND: Several statistical approaches have been proposed to assess and correct for exposure measurement error. We aimed to provide a critical overview of the most common approaches used in nutritional epidemiology. METHODS: MEDLINE, EMBASE, BIOSIS and CINAHL were searched for reports published in English up to May 2016 in order to ascertain studies that described methods aimed to quantify and/or correct for measurement error for a continuous exposure in nutritional epidemiology using a calibration study...
September 19, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28923013/pragmatic-clinical-trials-embedded-in-healthcare-systems-generalizable-lessons-from-the-nih-collaboratory
#5
Kevin P Weinfurt, Adrian F Hernandez, Gloria D Coronado, Lynn L DeBar, Laura M Dember, Beverly B Green, Patrick J Heagerty, Susan S Huang, Kathryn T James, Jeffrey G Jarvik, Eric B Larson, Vincent Mor, Richard Platt, Gary E Rosenthal, Edward J Septimus, Gregory E Simon, Karen L Staman, Jeremy Sugarman, Miguel Vazquez, Douglas Zatzick, Lesley H Curtis
BACKGROUND: The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc...
September 18, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28923007/patients-beliefs-regarding-informed-consent-for-low-risk-pragmatic-trials
#6
Rafael Dal-Ré, Antonio J Carcas, Xavier Carné, David Wendler
BACKGROUND: The requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients. METHODS: This was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night...
September 18, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28923006/repeat-a-framework-to-assess-empirical-reproducibility-in-biomedical-research
#7
Leslie D McIntosh, Anthony Juehne, Cynthia R H Vitale, Xiaoyan Liu, Rosalia Alcoser, J Christian Lukas, Bradley Evanoff
BACKGROUND: The reproducibility of research is essential to rigorous science, yet significant concerns of the reliability and verifiability of biomedical research have been recently highlighted. Ongoing efforts across several domains of science and policy are working to clarify the fundamental characteristics of reproducibility and to enhance the transparency and accessibility of research. METHODS: The aim of the proceeding work is to develop an assessment tool operationalizing key concepts of research transparency in the biomedical domain, specifically for secondary biomedical data research using electronic health record data...
September 18, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28915851/assessment-of-consent-models-as-an-ethical-consideration-in-the-conduct-of-prehospital-ambulance-randomised-controlled-clinical-trials-a-systematic-review
#8
Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P Appleton, Philip M Bath, Helen Snooks, A Niroshan Siriwardena
BACKGROUND: We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. METHODS: A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data...
September 16, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28903725/reporting-of-the-translation-and-cultural-adaptation-procedures-of-the-addenbrooke-s-cognitive-examination-version-iii-ace-iii-and-its-predecessors-a-systematic-review
#9
Nadine Mirza, Maria Panagioti, Muhammad Wali Waheed, Waquas Waheed
BACKGROUND: The ACE-III, a gold standard for screening cognitive impairment, is restricted by language and culture, with no uniform set of guidelines for its adaptation. To develop guidelines a compilation of all the adaptation procedures undertaken by adapters of the ACE-III and its predecessors is needed. METHODS: We searched EMBASE, Medline and PsychINFO and screened publications from a previous review. We included publications on adapted versions of the ACE-III and its predecessors, extracting translation and cultural adaptation procedures and assessing their quality...
September 13, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28899354/conducting-a-team-based-multi-sited-focused-ethnography-in-primary-care
#10
LETTER
A P Bikker, H Atherton, H Brant, T Porqueddu, J L Campbell, A Gibson, B McKinstry, C Salisbury, S Ziebland
Focused ethnography is an applied and pragmatic form of ethnography that explores a specific social phenomenon as it occurs in everyday life. Based on the literature a problem-focused research question is formulated before the data collection. The data generation process targets key informants and situations so that relevant results on the pre-defined topic can be obtained within a relatively short time-span. As part of a theory based evaluation of alternative forms of consultation (such as video, phone and email) in primary care we used the focused ethnographic method in a multisite study in general practice across the UK...
September 12, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28899342/measuring-the-burden-of-treatment-for-chronic-disease-implications-of-a-scoping-review-of-the-literature
#11
Adem Sav, Asiyeh Salehi, Frances S Mair, Sara S McMillan
BACKGROUND: Although there has been growing research on the burden of treatment, the current state of evidence on measuring this concept is unknown. This scoping review aimed to provide an overview of the current state of knowledge as well as clear recommendations for future research, within the context of chronic disease. METHODS: Four health-based databases, Scopus, CINAHL, Medline, and PsychInfo, were comprehensively searched for peer-reviewed articles published between the periods of 2000-2016...
September 12, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28888225/towards-evidence-based-computational-statistics-lessons-from-clinical-research-on-the-role-and-design-of-real-data-benchmark-studies
#12
Anne-Laure Boulesteix, Rory Wilson, Alexander Hapfelmeier
BACKGROUND: The goal of medical research is to develop interventions that are in some sense superior, with respect to patient outcome, to interventions currently in use. Similarly, the goal of research in methodological computational statistics is to develop data analysis tools that are themselves superior to the existing tools. The methodology of the evaluation of medical interventions continues to be discussed extensively in the literature and it is now well accepted that medicine should be at least partly "evidence-based"...
September 9, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28882125/evidence-mapping-based-on-systematic-reviews-of-therapeutic-interventions-for-gastrointestinal-stromal-tumors-gist
#13
Mónica Ballesteros, Nadia Montero, Antonio López-Pousa, Gerard Urrútia, Ivan Solà, Gabriel Rada, Hector Pardo-Hernandez, Xavier Bonfill
BACKGROUND: Gastrointestinal Stromal Tumours (GISTs) are the most common mesenchymal tumours. Currently, different pharmacological and surgical options are used to treat localised and metastatic GISTs, although this research field is broad and the body of evidence is scattered and expanding. Our objectives are to identify, describe and organise the current available evidence for GIST through an evidence mapping approach. METHODS: We followed the methodology of Global Evidence Mapping (GEM)...
September 7, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28882105/addressing-data-privacy-in-matched-studies-via-virtual-pooling
#14
P Saha-Chaudhuri, C R Weinberg
BACKGROUND: Data confidentiality and shared use of research data are two desirable but sometimes conflicting goals in research with multi-center studies and distributed data. While ideal for straightforward analysis, confidentiality restrictions forbid creation of a single dataset that includes covariate information of all participants. Current approaches such as aggregate data sharing, distributed regression, meta-analysis and score-based methods can have important limitations. METHODS: We propose a novel application of an existing epidemiologic tool, specimen pooling, to enable confidentiality-preserving analysis of data arising from a matched case-control, multi-center design...
September 7, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28882102/monte-carlo-simulation-based-estimation-for-the-minimum-mortality-temperature-in-temperature-mortality-association-study
#15
Whanhee Lee, Ho Kim, Sunghee Hwang, Antonella Zanobetti, Joel D Schwartz, Yeonseung Chung
BACKGROUND: Rich literature has reported that there exists a nonlinear association between temperature and mortality. One important feature in the temperature-mortality association is the minimum mortality temperature (MMT). The commonly used approach for estimating the MMT is to determine the MMT as the temperature at which mortality is minimized in the estimated temperature-mortality association curve. Also, an approximate bootstrap approach was proposed to calculate the standard errors and the confidence interval for the MMT...
September 7, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28877680/longitudinal-studies-that-use-data-collected-as-part-of-usual-care-risk-reporting-biased-results-a-systematic-review
#16
Delaram Farzanfar, Asmaa Abumuamar, Jayoon Kim, Emily Sirotich, Yue Wang, Eleanor Pullenayegum
BACKGROUND: Longitudinal studies using data collected as part of usual care risk providing biased results if visit times are related to the outcome of interest. Statistical methods for mitigating this bias are available but rarely used. This lack of use could be attributed to a lack of need or to a lack of awareness of the issue. METHODS: We performed a systematic review of longitudinal studies that used data collected as part of patients' usual care and were published in MEDLINE or EMBASE databases between January 2005 through May 13(th) 2015...
September 6, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28877666/multiple-imputation-for-handling-missing-outcome-data-when-estimating-the-relative-risk
#17
Thomas R Sullivan, Katherine J Lee, Philip Ryan, Amy B Salter
BACKGROUND: Multiple imputation is a popular approach to handling missing data in medical research, yet little is known about its applicability for estimating the relative risk. Standard methods for imputing incomplete binary outcomes involve logistic regression or an assumption of multivariate normality, whereas relative risks are typically estimated using log binomial models. It is unclear whether misspecification of the imputation model in this setting could lead to biased parameter estimates...
September 6, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28859617/factors-associated-with-attrition-in-a-longitudinal-online-study-results-from-the-habids-panel
#18
Nicole Rübsamen, Manas K Akmatov, Stefanie Castell, André Karch, Rafael T Mikolajczyk
BACKGROUND: Knowing about predictors of attrition in a panel is important to initiate early measures against loss of participants. We investigated attrition in both early and late phase of an online panel with special focus on preferences regarding mode of participation. METHODS: We used data from the HaBIDS panel that was designed to investigate knowledge, attitudes, and practice regarding infections in the German general population. HaBIDS was divided into two phases: an initial phase when some participants could choose their preferred mode of participation (paper-and-pencil or online) and an extended phase when participants were asked to become members of an online panel that was not limited regarding its duration (i...
August 31, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28841846/validity-and-reliability-of-a-performance-evaluation-tool-based-on-the-modified-barthel-index-for-stroke-patients
#19
Tomoko Ohura, Kimitaka Hase, Yoshie Nakajima, Takeo Nakayama
BACKGROUND: The Barthel Index (BI) is a measure of independence in activities of daily living (ADL). In the modified Barthel Index (MBI), a five-point system replaced the original two or three or four point rating system. Based on this modified measure, the performance evaluation tool MBI (PET-MBI) was developed in Japan. Although the reliability and validity of PET-MBI have been verified for older people, the use of this tool in stroke patients has not been evaluated. This study investigated the validity and reliability of PET-MBI for stroke patients...
August 25, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28835231/trends-in-the-number-and-the-quality-of-trial-protocols-involving-children-submitted-to-a-french-institutional-review-board
#20
Isabelle Gautier, Perrine Janiaud, Nelly Rollet, Nicolas André, Michel Tsimaratos, Catherine Cornu, Salma Malik, Stéphanie Gentile, Behrouz Kassaï
BACKGROUND: There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118) before and after the initiation of the EU Pediatric Regulation...
August 23, 2017: BMC Medical Research Methodology
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