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  1. Until recently a typical rule that has often been used for the endorsement of new medications by the Food and Drug Administration has been the existence of at least two statistically significant clinical trial...

    Authors: Don van Ravenzwaaij and John P. A. Ioannidis
    Citation: BMC Medical Research Methodology 2019 19:218
  2. Antimalarial clinical efficacy studies for uncomplicated Plasmodium falciparum malaria frequently encounter situations in which molecular genotyping is unable to discriminate between parasitic recurrence, either ...

    Authors: Prabin Dahal, Kasia Stepniewska, Philippe J. Guerin, Umberto D’Alessandro, Ric N. Price and Julie A. Simpson
    Citation: BMC Medical Research Methodology 2019 19:215
  3. Many population health surveys consist of a mixed-mode design that includes a face-to-face (F2F) interview followed by a paper-and-pencil (P&P) self-administered questionnaire (SAQ) for the sensitive topics. I...

    Authors: Elise Braekman, Sabine Drieskens, Rana Charafeddine, Stefaan Demarest, Finaba Berete, Lydia Gisle, Jean Tafforeau, Johan Van der Heyden and Guido Van Hal
    Citation: BMC Medical Research Methodology 2019 19:212
  4. Engaging those who influence, administer and/or who are active users (“knowledge users”) of health care systems, as co-producers of health research, can help to ensure that research products will better addres...

    Authors: Janet E. Jull, Laurie Davidson, Rachel Dungan, Tram Nguyen, Krista P. Woodward and Ian D. Graham
    Citation: BMC Medical Research Methodology 2019 19:211
  5. Large and complex population-based cancer data are becoming broadly available, thanks to purposeful linkage between cancer registry data and health electronic records. Aiming at understanding the explanatory p...

    Authors: Camille Maringe, Aurélien Belot, Francisco Javier Rubio and Bernard Rachet
    Citation: BMC Medical Research Methodology 2019 19:210
  6. The analysis of twin data presents a unique challenge. Second-born twins on average weigh less than first-born twins and have an elevated risk of perinatal mortality. It is not clear whether the risk differenc...

    Authors: Muhammad Abu Shadeque Mullah, James A. Hanley and Andrea Benedetti
    Citation: BMC Medical Research Methodology 2019 19:209
  7. Central cancer registries are often used to survey population-based samples of cancer survivors. These surveys are typically administered via paper or telephone. In most populations, web surveys obtain much lo...

    Authors: Morgan M. Millar, Joanne W. Elena, Lisa Gallicchio, Sandra L. Edwards, Marjorie E. Carter, Kimberly A. Herget and Carol Sweeney
    Citation: BMC Medical Research Methodology 2019 19:208
  8. Recently, there has been a heightened interest in developing and evaluating different methods for analysing observational data. This has been driven by the increased availability of large data resources such a...

    Authors: E. R. John, K. R. Abrams, C. E. Brightling and N. A. Sheehan
    Citation: BMC Medical Research Methodology 2019 19:207
  9. Clinical quality registries and other systems that conduct routine post-discharge surveillance of patient outcomes following surgery may have difficulty surveying patients who have limited proficiency in the l...

    Authors: Daniel Xue, Timothy Churches, Elizabeth Armstrong, Rajat Mittal, Justine Maree Naylor and Ian Andrew Harris
    Citation: BMC Medical Research Methodology 2019 19:206
  10. Increasing rates of long-term sickness absence are a worldwide problem. Belgium is the first country in Europe that aims to screen its entire population of sick leavers (sick leave > 6 weeks) for the risk of l...

    Authors: Kaat Goorts, Charlotte Vanovenberghe, Charlotte Lambreghts, Eline Bruneel, Dorina Rusu, Marc Du Bois, Sofie Vandenbroeck and Lode Godderis
    Citation: BMC Medical Research Methodology 2019 19:205

    The Correction to this article has been published in BMC Medical Research Methodology 2019 19:224

  11. Clinical study reports (CSRs) have been increasingly utilised within academic research in recent years. European Medicines Agency (EMA) Policy 0070 ‘Phase 1,’ which came into effect in January 2015, requires t...

    Authors: Jean-Marc Ferran and Sarah J. Nevitt
    Citation: BMC Medical Research Methodology 2019 19:204
  12. A standard or consensus definition of a systematic review does not exist. Therefore, if there is no definition about a systematic review in secondary studies that analyse them or the definition is too broad, i...

    Authors: Marina Krnic Martinic, Dawid Pieper, Angelina Glatt and Livia Puljak
    Citation: BMC Medical Research Methodology 2019 19:203
  13. It is unclear whether weighted or unweighted regression is preferred in the analysis of data derived from respondent driven sampling. Our objective was to evaluate the validity of various regression models, wi...

    Authors: Lisa Avery, Nooshin Rotondi, Constance McKnight, Michelle Firestone, Janet Smylie and Michael Rotondi
    Citation: BMC Medical Research Methodology 2019 19:202
  14. Longitudinal research has demonstrated that experiences of abuse and adversity are not consistently reported over time; however, there is a paucity of available evidence regarding the consistency of reporting ...

    Authors: Deborah Loxton, Jennifer Powers, Natalie Townsend, Melissa L. Harris and Peta Forder
    Citation: BMC Medical Research Methodology 2019 19:201
  15. New emerging diseases are public health concerns in which policy makers have to make decisions in the presence of enormous uncertainty. This is an important challenge in terms of emergency preparation requirin...

    Authors: Chawarat Rotejanaprasert, Andrew B. Lawson and Sopon Iamsirithaworn
    Citation: BMC Medical Research Methodology 2019 19:200
  16. The incorporation of repeated measurements into multivariable prediction research may greatly enhance predictive performance. However, the methodological possibilities vary widely and a structured overview of ...

    Authors: Joost D. J. Plate, Rutger R. van de Leur, Luke P. H. Leenen, Falco Hietbrink, Linda M. Peelen and M. J. C. Eijkemans
    Citation: BMC Medical Research Methodology 2019 19:199
  17. When investigating subgroup effects in meta-analysis, it is unclear whether accounting in meta-regression for between-trial variation in treatment effects, but not between-trial variation in treatment interact...

    Authors: Bruno R. da Costa and Alex J. Sutton
    Citation: BMC Medical Research Methodology 2019 19:198
  18. In the early years of life, the benefits of parental engagement in children’s learning are well documented. Early childhood educators are a potentially effective source of support, having opportunity to engage...

    Authors: Zvezdana Petrovic, Olivia Clayton, Jan Matthews, Catherine Wade, Lina Tan, Denny Meyer, Antony Gates, Alex Almendingen and Warren Cann
    Citation: BMC Medical Research Methodology 2019 19:197
  19. Several reviews have noted shortcomings regarding the quality and reporting of network meta-analyses (NMAs). We suspect that this issue may be partially attributable to limitations in current NMA software whic...

    Authors: Audrey Béliveau, Devon J. Boyne, Justin Slater, Darren Brenner and Paul Arora
    Citation: BMC Medical Research Methodology 2019 19:196
  20. Recruitment to health research remains a major challenge. Innovation is required to meet policy commitments to help patients take part in health research. One innovation that may help meet those policy goals i...

    Authors: Katherine Grady, Martin Gibson and Peter Bower
    Citation: BMC Medical Research Methodology 2019 19:195
  21. Validation studies on an ICD-10-based algorithm to identify major bleeding events are scarce, and mostly focused on positive predictive values.

    Authors: Emmanuel Oger, Marie-Anne Botrel, Catherine Juchault and Jacques Bouget
    Citation: BMC Medical Research Methodology 2019 19:194
  22. The importance of adjusting for cross-study heterogeneity in control group response rates when conducting network meta-analyses (NMA) was demonstrated using a case study involving a comparison of biologics for...

    Authors: Chris Cameron, Abhishek Varu, Arthur Lau, Mahdi Gharaibeh, Marcelo Paulino and Raina Rogoza
    Citation: BMC Medical Research Methodology 2019 19:193
  23. Locally produced generic drugs offer a cost–effective alternative to imported drugs to treat patients in Ethiopia. However, due to a lack of bioequivalence testing, additional assurance tests are needed to bui...

    Authors: Chalachew Alemayehu, Geoff Mitchell, Jane Nikles, Abraham Aseffa and Alexandra Clavarino
    Citation: BMC Medical Research Methodology 2019 19:192
  24. Online clinical risk prediction tools built on data from multiple cohorts are increasingly being utilized for contemporary doctor-patient decision-making and validation. This report outlines a comprehensive da...

    Authors: Johanna Tolksdorf, Michael W. Kattan, Stephen A. Boorjian, Stephen J. Freedland, Karim Saba, Cedric Poyet, Lourdes Guerrios, Amanda De Hoedt, Michael A. Liss, Robin J. Leach, Javier Hernandez, Emily Vertosick, Andrew J. Vickers and Donna P. Ankerst
    Citation: BMC Medical Research Methodology 2019 19:191
  25. In the original publication of this article [1], the author noted two corrections after publication.

    Authors: Maria Pufulete, Jessica Harris, Stephen Dorman, Lynn Cook, Chiara Bucciarelli-Ducci, John P. Greenwood, Richard Anderson, Rachel Brierley and Barnaby C. Reeves
    Citation: BMC Medical Research Methodology 2019 19:190

    The original article was published in BMC Medical Research Methodology 2019 19:116

  26. Several literature reviews have been published focusing on the prevalence and/or preventability of hospital readmissions. To our knowledge, none focused on the different causes which have been used to evaluate...

    Authors: R. G. Singotani, F. Karapinar, C. Brouwers, C. Wagner and M. C. de Bruijne
    Citation: BMC Medical Research Methodology 2019 19:189

    The Correction to this article has been published in BMC Medical Research Methodology 2019 19:214

  27. The Pain Medication Questionnaire (PMQ) assesses the risk of opioid abuse in people with non-oncological chronic pain.

    Authors: Sheila Raposo Galindo, Manoel Henrique da Nóbrega Marinho, Robert J. Gatchel, Tatiana de Paula Santana da Silva, Eduardo Henrique Soares Viana, Selene Cordeiro Vasconcelos and Murilo Duarte da Costa Lima
    Citation: BMC Medical Research Methodology 2019 19:188
  28. When conducing Phase-III trial, regulatory agencies and investigators might want to get reliable information about rare but serious safety outcomes during the trial. Bayesian non-inferiority approaches have be...

    Authors: Camille Aupiais, Corinne Alberti, Thomas Schmitz, Olivier Baud, Moreno Ursino and Sarah Zohar
    Citation: BMC Medical Research Methodology 2019 19:187
  29. Population attributable fractions (PAF) measure the proportion of disease prevalence that would be avoided in a hypothetical population, similar to the population of interest, but where a particular risk facto...

    Authors: John Ferguson, Neil O’Leary, Fabrizio Maturo, Salim Yusuf and Martin O’Donnell
    Citation: BMC Medical Research Methodology 2019 19:186
  30. An overarching objective in research comparing different sample groups is to ensure that the reported differences in outcomes are not affected by differences between groups in the functioning of the measuremen...

    Authors: Curt Hagquist
    Citation: BMC Medical Research Methodology 2019 19:185
  31. This article describes a bibliometric review of the scientific production, geographical distribution, collaboration, impact, and subject area focus of pneumonia research indexed on the Web of Science over a 15...

    Authors: José M. Ramos-Rincón, Héctor Pinargote-Celorio, Isabel Belinchón-Romero and Gregorio González-Alcaide
    Citation: BMC Medical Research Methodology 2019 19:184
  32. Individual participant data meta-analysis (IPD-MA) is considered the gold standard for investigating subgroup effects. Frequently used regression-based approaches to detect subgroups in IPD-MA are: meta-regres...

    Authors: Michail Belias, Maroeska M. Rovers, Johannes B. Reitsma, Thomas P. A. Debray and Joanna IntHout
    Citation: BMC Medical Research Methodology 2019 19:183
  33. Long-term clinical outcomes are necessary to assess the cost-effectiveness of new treatments over a lifetime horizon. Without long-term clinical trial data, current practice to extrapolate survival beyond the ...

    Authors: Shannon Cope, Dieter Ayers, Jie Zhang, Katharine Batt and Jeroen P. Jansen
    Citation: BMC Medical Research Methodology 2019 19:182
  34. Loneliness and social isolation are major determinants of mental wellbeing, especially among older adults. The effectiveness of interventions to address loneliness and social isolation among older adults has b...

    Authors: Janet Ige, Lynn Gibbons, Issy Bray and Selena Gray
    Citation: BMC Medical Research Methodology 2019 19:181
  35. The use of systematic review methods are widely recognized to be essential in the development of recommendations in clinical practice guidelines to prove their trustworthiness. The objective of this study was ...

    Authors: Chiara Trevisiol, Michela Cinquini, Aline S. C. Fabricio, Massimo Gion and Anne W. S. Rutjes
    Citation: BMC Medical Research Methodology 2019 19:180
  36. Health services have not provided adequate support for young people with long term health conditions to transfer from child to adult services. National Institute of Health and Care (NICE) guidance on transitio...

    Authors: Helen Eke, Astrid Janssens, Johnny Downs, Richard M. Lynn, Cornelius Ani and Tamsin Ford
    Citation: BMC Medical Research Methodology 2019 19:179
  37. Current methods for assessing strength of evidence prioritize the contributions of randomized controlled trials (RCTs). The objective of this study was to characterize strength of evidence (SOE) tools in recen...

    Authors: D. L. Katz, M. C. Karlsen, M. Chung, M. M. Shams-White, L. W. Green, J. Fielding, A. Saito and W. Willett
    Citation: BMC Medical Research Methodology 2019 19:178
  38. The use of real-world data to generate evidence requires careful assessment and validation of critical variables before drawing clinical conclusions. Prospective clinical trial data suggest that anatomic origi...

    Authors: Patricia Luhn, Deborah Kuk, Gillis Carrigan, Nathan Nussbaum, Rachael Sorg, Rebecca Rohrer, Melisa G. Tucker, Brandon Arnieri, Michael D. Taylor and Neal J. Meropol
    Citation: BMC Medical Research Methodology 2019 19:177
  39. Muscular dystrophies (MDs) are a group of inherited conditions characterized by progressive muscle degeneration and weakness. The rarity and heterogeneity of the population with MD have hindered therapeutic de...

    Authors: Xiaoxue Chen, Abiy Agiro, Ann S. Martin, Ann M. Lucas and Kevin Haynes
    Citation: BMC Medical Research Methodology 2019 19:174
  40. Research reporting guidelines are increasingly commonplace and shown to improve the quality of published health research and health outcomes. Despite severe health inequities among Indigenous Peoples and the p...

    Authors: Tania Huria, Suetonia C. Palmer, Suzanne Pitama, Lutz Beckert, Cameron Lacey, Shaun Ewen and Linda Tuhiwai Smith
    Citation: BMC Medical Research Methodology 2019 19:173
  41. Hospitals are common recruitment sites for injury and disability studies. However, the clinical and rehabilitation environment can create unique challenges for researchers to recruit participant populations. W...

    Authors: Michelle S. Fitts, Taeha Condon, John Gilroy, Katrina Bird, Erica Bleakley, Lauren Matheson, Jennifer Fleming, Alan R. Clough, Adrian Esterman, Paul Maruff and India Bohanna
    Citation: BMC Medical Research Methodology 2019 19:172
  42. Participants in voluntary research present a different demographic profile than those who choose not to participate, affecting the generalizability of many studies. Efforts to evaluate these differences have f...

    Authors: Simone Dahrouge, Catherine Deri Armstrong, William Hogg, Jatinderpreet Singh and Clare Liddy
    Citation: BMC Medical Research Methodology 2019 19:171
  43. Assessing the risk of bias (RoB) in included studies is one of the key methodological aspects of systematic reviews. Cochrane systematic reviews appraise RoB of randomised controlled trials (RCTs) with the Coc...

    Authors: Ognjen Barcot, Matija Boric, Tina Poklepovic Pericic, Marija Cavar, Svjetlana Dosenovic, Ivana Vuka and Livia Puljak
    Citation: BMC Medical Research Methodology 2019 19:170
  44. Longitudinal qualitative research is starting to be used in applied health research, having been popular in social research for several decades. There is potential for a large volume of complex data to be capt...

    Authors: Laura Sheard and Claire Marsh
    Citation: BMC Medical Research Methodology 2019 19:169
  45. Today we are often interested in the predictive value of a continuous marker with respect to the expected difference in outcome between a new treatment and a standard treatment. We can investigate this in a ra...

    Authors: Maren Eckert and Werner Vach
    Citation: BMC Medical Research Methodology 2019 19:168
  46. Patient Reported Outcomes (PRO) are gaining more and more importance in the context of clinical trials. The assessment of PRO is frequently performed by questionnaires where the multiple items of a questionnai...

    Authors: Manuel Feißt, André Hennigs, Jörg Heil, Helfried Moosbrugger, Augustin Kelava, Ilona Stolpner, Meinhard Kieser and Geraldine Rauch
    Citation: BMC Medical Research Methodology 2019 19:167
  47. Analysis of competing risks is commonly achieved through a cause specific or a subdistribution framework using Cox or Fine & Gray models, respectively. The estimation of treatment effects in observational data...

    Authors: Michael Andrew Barrowman, Niels Peek, Mark Lambie, Glen Philip Martin and Matthew Sperrin
    Citation: BMC Medical Research Methodology 2019 19:166
  48. Although criticisms regarding the dichotomisation of continuous variables are well known, applying logit model to dichotomised outcomes is the convention because the odds ratios are easily obtained and they ap...

    Authors: Ying Chen, Yilin Ning, Shih Ling Kao, Nathalie C. Støer, Falk Müller-Riemenschneider, Kavita Venkataraman, Eric Yin Hao Khoo, E-Shyong Tai and Chuen Seng Tan
    Citation: BMC Medical Research Methodology 2019 19:165

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