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  1. Research article

    Design considerations and analysis planning of a phase 2a proof of concept study in rheumatoid arthritis in the presence of possible non-monotonicity

    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 be...

    Feng Liu, Stephen J. Walters and Steven A. Julious

    BMC Medical Research Methodology 2017 17:149

    Published on: 2 October 2017

  2. Research Article

    Item response models for the longitudinal analysis of health-related quality of life in cancer clinical trials

    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,...

    Antoine Barbieri, Jean Peyhardi, Thierry Conroy, Sophie Gourgou, Christian Lavergne and Caroline Mollevi

    BMC Medical Research Methodology 2017 17:148

    Published on: 26 September 2017

  3. Research article

    Predicting the multi-domain progression of Parkinson’s disease: a Bayesian multivariate generalized linear mixed-effect model

    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.

    Ming Wang, Zheng Li, Eun Young Lee, Mechelle M. Lewis, Lijun Zhang, Nicholas W. Sterling, Daymond Wagner, Paul Eslinger, Guangwei Du and Xuemei Huang

    BMC Medical Research Methodology 2017 17:147

    Published on: 25 September 2017

  4. Research article

    Systematic review of statistical approaches to quantify, or correct for, measurement error in a continuous exposure in nutritional epidemiology

    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.

    Derrick A. Bennett, Denise Landry, Julian Little and Cosetta Minelli

    BMC Medical Research Methodology 2017 17:146

    Published on: 19 September 2017

  5. Research article

    Repeat: a framework to assess empirical reproducibility in biomedical research

    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 sev...

    Leslie D. McIntosh, Anthony Juehne, Cynthia R. H. Vitale, Xiaoyan Liu, Rosalia Alcoser, J. Christian Lukas and Bradley Evanoff

    BMC Medical Research Methodology 2017 17:143

    Published on: 18 September 2017

  6. Research article

    Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

    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 ...

    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…

    BMC Medical Research Methodology 2017 17:144

    Published on: 18 September 2017

  7. Research article

    Patients’ beliefs regarding informed consent for low-risk pragmatic trials

    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 statistic...

    Rafael Dal-Ré, Antonio J. Carcas, Xavier Carné and David Wendler

    BMC Medical Research Methodology 2017 17:145

    Published on: 18 September 2017

  8. Research article

    Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review

    We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting.

    Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P. Appleton, Philip M. Bath, Helen Snooks and A. Niroshan Siriwardena

    BMC Medical Research Methodology 2017 17:142

    Published on: 16 September 2017

  9. Research article

    Reporting of the translation and cultural adaptation procedures of the Addenbrooke’s Cognitive Examination version III (ACE-III) and its predecessors: a systematic review

    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 adap...

    Nadine Mirza, Maria Panagioti, Muhammad Wali Waheed and Waquas Waheed

    BMC Medical Research Methodology 2017 17:141

    Published on: 13 September 2017

  10. Correspondence

    Conducting a team-based multi-sited focused ethnography in primary care

    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 form...

    A.P. Bikker, H. Atherton, H. Brant, T. Porqueddu, J.L. Campbell, A. Gibson, B. McKinstry, C. Salisbury and S. Ziebland

    BMC Medical Research Methodology 2017 17:139

    Published on: 12 September 2017

  11. Debate

    Towards evidence-based computational statistics: lessons from clinical research on the role and design of real-data benchmark studies

    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 c...

    Anne-Laure Boulesteix, Rory Wilson and Alexander Hapfelmeier

    BMC Medical Research Methodology 2017 17:138

    Published on: 9 September 2017

  12. Research article

    Monte Carlo simulation-based estimation for the minimum mortality temperature in temperature-mortality association study

    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 (MM...

    Whanhee Lee, Ho Kim, Sunghee Hwang, Antonella Zanobetti, Joel D. Schwartz and Yeonseung Chung

    BMC Medical Research Methodology 2017 17:137

    Published on: 7 September 2017

  13. Research article

    Evidence mapping based on systematic reviews of therapeutic interventions for gastrointestinal stromal tumors (GIST)

    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 resea...

    Mónica Ballesteros, Nadia Montero, Antonio López-Pousa, Gerard Urrútia, Ivan Solà, Gabriel Rada, Hector Pardo-Hernandez and Xavier Bonfill

    BMC Medical Research Methodology 2017 17:135

    Published on: 7 September 2017

  14. Research article

    Addressing data privacy in matched studies via virtual pooling

    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, conf...

    P. Saha-Chaudhuri and C.R. Weinberg

    BMC Medical Research Methodology 2017 17:136

    Published on: 7 September 2017

  15. Research article

    Longitudinal studies that use data collected as part of usual care risk reporting biased results: a systematic review

    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 b...

    Delaram Farzanfar, Asmaa Abumuamar, Jayoon Kim, Emily Sirotich, Yue Wang and Eleanor Pullenayegum

    BMC Medical Research Methodology 2017 17:133

    Published on: 6 September 2017

  16. Research article

    Factors associated with attrition in a longitudinal online study: results from the HaBIDS panel

    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 foc...

    Nicole Rübsamen, Manas K. Akmatov, Stefanie Castell, André Karch and Rafael T. Mikolajczyk

    BMC Medical Research Methodology 2017 17:132

    Published on: 31 August 2017

  17. Research article

    Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board

    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 ...

    Isabelle Gautier, Perrine Janiaud, Nelly Rollet, Nicolas André, Michel Tsimaratos, Catherine Cornu, Salma Malik, Stéphanie Gentile and Behrouz Kassaï

    BMC Medical Research Methodology 2017 17:130

    Published on: 23 August 2017

  18. Research article

    Using Bayesian statistics to estimate the likelihood a new trial will demonstrate the efficacy of a new treatment

    The common frequentist approach is limited in providing investigators with appropriate measures for conducting a new trial. To answer such important questions and one has to look at Bayesian statistics.

    David J. Biau, Samuel Boulezaz, Laurent Casabianca, Moussa Hamadouche, Philippe Anract and Sylvie Chevret

    BMC Medical Research Methodology 2017 17:128

    Published on: 22 August 2017

  19. Technical advance

    Methods for significance testing of categorical covariates in logistic regression models after multiple imputation: power and applicability analysis

    Multiple imputation is a recommended method to handle missing data. For significance testing after multiple imputation, Rubin’s Rules (RR) are easily applied to pool parameter estimates. In a logistic regressi...

    Iris Eekhout, Mark A. van de Wiel and Martijn W. Heymans

    BMC Medical Research Methodology 2017 17:129

    Published on: 22 August 2017

  20. Research article

    Statistical methods for elimination of guarantee-time bias in cohort studies: a simulation study

    Aspirin has been considered to be beneficial in preventing cardiovascular diseases and cancer. Several pharmaco-epidemiology cohort studies have shown protective effects of aspirin on diseases using various st...

    In Sung Cho, Ye Rin Chae, Ji Hyeon Kim, Hae Rin Yoo, Suk Yong Jang, Gyu Ri Kim and Chung Mo Nam

    BMC Medical Research Methodology 2017 17:126

    Published on: 22 August 2017

  21. Research article

    The impact of self-interviews on response patterns for sensitive topics: a randomized trial of electronic delivery methods for a sexual behaviour questionnaire in rural South Africa

    Self-interviews, where the respondent rather than the interviewer enters answers to questions, have been proposed as a way to reduce social desirability bias associated with interviewer-led interviews. Compute...

    Guy Harling, Dumile Gumede, Tinofa Mutevedzi, Nuala McGrath, Janet Seeley, Deenan Pillay, Till W. Bärnighausen and Abraham J. Herbst

    BMC Medical Research Methodology 2017 17:125

    Published on: 17 August 2017

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