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  1. Sample size calculation is a key point in the design of a randomized controlled trial. With time-to-event outcomes, it’s often based on the logrank test. We provide a sample size calculation method for a compo...

    Authors: Jordi Cortés Martínez, Ronald B. Geskus, KyungMann Kim and Guadalupe Gómez Melis

    Citation: BMC Medical Research Methodology 2021 21:99

    Content type: Research

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  2. Viral haemorrhagic fevers are characterized by irregular outbreaks with high mortality rate. Difficulties arise when implementing therapeutic trials in this context. The outbreak duration is hard to predict an...

    Authors: Pauline Manchon, Drifa Belhadi, France Mentré and Cédric Laouénan

    Citation: BMC Medical Research Methodology 2021 21:98

    Content type: Research article

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  3. In longitudinal critical care studies, researchers may be interested in summarizing an exposure over time and evaluating its association with a long-term outcome. For example, the number of days a patient has ...

    Authors: Rameela Raman, Wencong Chen, Michael O. Harhay, Jennifer L. Thompson, E. Wesley Ely, Pratik P. Pandharipande and Mayur B. Patel

    Citation: BMC Medical Research Methodology 2021 21:97

    Content type: Research article

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  4. Diagnosis performances of case-identifying algorithms developed in healthcare database are usually assessed by comparing identified cases with an external data source. When this is not feasible, intra-database...

    Authors: Nicolas H. Thurin, Pauline Bosco-Levy, Patrick Blin, Magali Rouyer, Jérémy Jové, Stéphanie Lamarque, Séverine Lignot, Régis Lassalle, Abdelilah Abouelfath, Emmanuelle Bignon, Pauline Diez, Marine Gross-Goupil, Michel Soulié, Mathieu Roumiguié, Sylvestre Le Moulec, Marc Debouverie…

    Citation: BMC Medical Research Methodology 2021 21:95

    Content type: Research article

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  5. Systematic reviews (SRs) are considered one of the most reliable types of studies in evidence-based medicine. SRs rely on a comprehensive and systematic data gathering, including the search of academic literat...

    Authors: Tobias Justesen, Josefine Freyberg and Anders N. Ø. Schultz

    Citation: BMC Medical Research Methodology 2021 21:94

    Content type: Research article

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  6. The availability of large epidemiological or clinical data storing biological samples allow to study the prognostic value of novel biomarkers, but efficient designs are needed to select a subsample on which to...

    Authors: Francesca Graziano, Maria Grazia Valsecchi and Paola Rebora

    Citation: BMC Medical Research Methodology 2021 21:93

    Content type: Research article

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  7. Clinical trials in home hospice settings are important to build the evidence base for practice, but balancing the burden and benefit of clinical trial conduct for clinicians, patients, and family caregivers is...

    Authors: Jennifer Tjia, Margaret Clayton, Germán Chiriboga, Brooke Staples, Geraldine Puerto, Lynley Rappaport and Susan DeSanto-Madeya

    Citation: BMC Medical Research Methodology 2021 21:92

    Content type: Research article

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  8. During the COVID-19 emergency, IRST IRCCS, an Italian cancer research institute and promoter of no profit clinical studies, adapted its activities and procedures as per European and national guidelines to main...

    Authors: Linda Valmorri, Bernadette Vertogen, Chiara Zingaretti, Anna Miserocchi, Roberta Volpi, Alberto Clemente, Isabella Bondi, Irene Valli, Britt Rudnas, Giovanni Martinelli and Oriana Nanni

    Citation: BMC Medical Research Methodology 2021 21:91

    Content type: Commentary

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  9. Healthcare-associated infections (HAIs) represent a major Public Health issue. Hospital-based prevalence studies are a common tool of HAI surveillance, but data quality problems and non-representativeness can ...

    Authors: A. D’Ambrosio, J. Garlasco, F. Quattrocolo, C. Vicentini and C. M. Zotti

    Citation: BMC Medical Research Methodology 2021 21:90

    Content type: Technical advance

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  10. Survival analyses methods (SAMs) are central to analysing time-to-event outcomes. Appropriate application and reporting of such methods are important to ensure correct interpretation of the data. In this study...

    Authors: Moses M. Ngari, Susanne Schmitz, Christopher Maronga, Lazarus K. Mramba and Michel Vaillant

    Citation: BMC Medical Research Methodology 2021 21:89

    Content type: Research article

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  11. Crowdsourcing engages the help of large numbers of people in tasks, activities or projects, usually via the internet. One application of crowdsourcing is the screening of citations for inclusion in a systemati...

    Authors: Anna H. Noel-Storr, Patrick Redmond, Guillaume Lamé, Elisa Liberati, Sarah Kelly, Lucy Miller, Gordon Dooley, Andy Paterson and Jenni Burt

    Citation: BMC Medical Research Methodology 2021 21:88

    Content type: Research article

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  12. Short-term associations between extreme heat events and adverse health outcomes are well-established in epidemiologic studies. However, the use of different exposure definitions across studies has limited our ...

    Authors: Shan Jiang, Joshua L. Warren, Noah Scovronick, Shannon E. Moss, Lyndsey A. Darrow, Matthew J. Strickland, Andrew J. Newman, Yong Chen, Stefanie T. Ebelt and Howard H. Chang

    Citation: BMC Medical Research Methodology 2021 21:87

    Content type: Research article

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  13. Health-related quality of life (HRQoL) tools are limited by the indicators included in the construct and variation in interpretation by different researchers. Neutral Theory describes the ideal construct that ...

    Authors: Ravi Jandhyala

    Citation: BMC Medical Research Methodology 2021 21:86

    Content type: Research article

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  14. Asset-based indices are widely-used proxy measures of wealth in low and middle-income countries (LMIC). The stability of these indices within households over time is not known.

    Authors: Jithin Sam Varghese, John A. Maluccio, Solveig A. Cunningham, Manuel Ramirez-Zea and Aryeh D. Stein

    Citation: BMC Medical Research Methodology 2021 21:85

    Content type: Research article

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  15. When quantifying the probability of survival in cancer patients using cancer registration data, it is common to estimate marginal relative survival, which under assumptions can be interpreted as marginal net s...

    Authors: Paul C. Lambert, Elisavet Syriopoulou and Mark R. Rutherford

    Citation: BMC Medical Research Methodology 2021 21:84

    Content type: Research article

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  16. Generalized linear mixed models (GLMMs), typically used for analyzing correlated data, can also be used for smoothing by considering the knot coefficients from a regression spline as random effects. The result...

    Authors: Muhammad Abu Shadeque Mullah, James A. Hanley and Andrea Benedetti

    Citation: BMC Medical Research Methodology 2021 21:83

    Content type: Research article

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  17. The COVID-19 pandemic has become a source of fear across the world. Measuring the level or significance of fear in different populations may help identify populations and areas in need of public health and edu...

    Authors: Ashley Elizabeth Muller, Jan Peter William Himmels and Stijn Van de Velde

    Citation: BMC Medical Research Methodology 2021 21:82

    Content type: Research article

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  18. Identifying how unwarranted variations in healthcare delivery arise is challenging. Experimental vignette studies can help, by isolating and manipulating potential drivers of differences in care. There is a la...

    Authors: Jessica Sheringham, Isla Kuhn and Jenni Burt

    Citation: BMC Medical Research Methodology 2021 21:81

    Content type: Research article

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  19. Research participation is beneficial to patients, clinicians and healthcare services. There is currently poor alignment between UK clinical research activity and local prevalence of disease. The National Insti...

    Authors: Tanvi Rai, Sharon Dixon and Sue Ziebland

    Citation: BMC Medical Research Methodology 2021 21:80

    Content type: Research article

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  20. An assumption in many analyses of longitudinal patient-reported outcome (PRO) data is that there is a single population following a single health trajectory. One approach that may help researchers move beyond ...

    Authors: Jae-Yung Kwon, Richard Sawatzky, Jennifer Baumbusch, Sandra Lauck and Pamela A. Ratner

    Citation: BMC Medical Research Methodology 2021 21:79

    Content type: Research article

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  21. Missing data is a pervasive problem in clinical research. Generative adversarial imputation nets (GAIN), a novel machine learning data imputation approach, has the potential to substitute missing data accurate...

    Authors: Weinan Dong, Daniel Yee Tak Fong, Jin-sun Yoon, Eric Yuk Fai Wan, Laura Elizabeth Bedford, Eric Ho Man Tang and Cindy Lo Kuen Lam

    Citation: BMC Medical Research Methodology 2021 21:78

    Content type: Research article

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  22. Patient-reported outcome measures (PROMs) are commonly-used surrogates for clinical outcomes in cancer research. When researching severe diseases such as cancer, it is difficult to avoid the problem of incompl...

    Authors: Pimrapat Gebert, Daniel Schindel, Johann Frick, Liane Schenk and Ulrike Grittner

    Citation: BMC Medical Research Methodology 2021 21:77

    Content type: Research article

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  23. The expansion of access to antiretroviral therapy (ART) has been accompanied by an increase in pre-treatment drug resistance (PDR). While it is critical to monitor the increasing prevalence of PDR across count...

    Authors: Lawrence Mbuagbaw, Clémence Ongolo-Zogo, Olivia C. Mendoza, Babalwa Zani, Frederick Morfaw, Agatha Nyambi, Annie Wang, Michel Kiflen, Hussein El-Kechen, Alvin Leenus, Mark Youssef, Nadia Rehman, Lucas Hermans, Virginia MacDonald and Silvia Bertagnolio

    Citation: BMC Medical Research Methodology 2021 21:76

    Content type: Research article

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  24. In non-inferiority trials, there is a concern that intention-to-treat (ITT) analysis, by including participants who did not receive the planned interventions, may bias towards making the treatment and control ...

    Authors: Anthony D. Bai, Adam S. Komorowski, Carson K. L. Lo, Pranav Tandon, Xena X. Li, Vaibhav Mokashi, Anna Cvetkovic, Aidan Findlater, Laurel Liang, George Tomlinson, Mark Loeb and Dominik Mertz

    Citation: BMC Medical Research Methodology 2021 21:75

    Content type: Research article

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  25. Chest pain is among the most common presenting complaints in the emergency department (ED). Swift and accurate risk stratification of chest pain patients in the ED may improve patient outcomes and reduce unnec...

    Authors: Nan Liu, Marcel Lucas Chee, Zhi Xiong Koh, Su Li Leow, Andrew Fu Wah Ho, Dagang Guo and Marcus Eng Hock Ong

    Citation: BMC Medical Research Methodology 2021 21:74

    Content type: Research article

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  26. Recommendations within guidelines are developed by synthesising the best available evidence; when limited evidence is identified recommendations are generally based on informal consensus. However, there are po...

    Authors: P. Carter, K. J. M. O’Donoghue, K. Dworzynski, L. O’Shea, V. Roberts, T. Reeves, A. Bastounis, M. A. Mugglestone, J. Fawke and S. Pilling

    Citation: BMC Medical Research Methodology 2021 21:73

    Content type: Research article

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  27. Missing data are common in randomised controlled trials (RCTs) and can bias results if not handled appropriately. A statistically valid analysis under the primary missing-data assumptions should be conducted, ...

    Authors: Ping-Tee Tan, Suzie Cro, Eleanor Van Vogt, Matyas Szigeti and Victoria R. Cornelius

    Citation: BMC Medical Research Methodology 2021 21:72

    Content type: Research article

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  28. Burn is a tragic event for an individual, the family, and community. It can cause irreparable physical, mental, economic, and social injury. Researches well documented that a quick visit to a healthcare center...

    Authors: Touraj Ahmadi-Jouybari, Somayeh Najafi-Ghobadi, Reza Karami-Matin, Saeid Najafian-Ghobadi and Khadijeh Najafi-Ghobadi,

    Citation: BMC Medical Research Methodology 2021 21:71

    Content type: Research article

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  29. Conventional methods for phase I dose-escalation trials in oncology are based on a single treatment schedule only. More recently, however, multiple schedules are more frequently investigated in the same trial.

    Authors: Burak Kürsad Günhan, Sebastian Weber, Abdelkader Seroutou and Tim Friede

    Citation: BMC Medical Research Methodology 2021 21:69

    Content type: Research article

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  30. The spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the ...

    Authors: Suzanne M. Simkovich, Lisa M. Thompson, Maggie L. Clark, Kalpana Balakrishnan, Alejandra Bussalleu, William Checkley, Thomas Clasen, Victor G. Davila-Roman, Anaite Diaz-Artiga, Ephrem Dusabimana, Lisa de las Fuentes, Steven Harvey, Miles A. Kirby, Amy Lovvorn, Eric D. McCollum, Erick E. Mollinedo…

    Citation: BMC Medical Research Methodology 2021 21:68

    Content type: Research article

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  31. Staquet et al. and Brenner both developed correction methods to estimate the sensitivity and specificity of a binary-response index test when the reference standard is imperfect and its sensitivity and specifi...

    Authors: Chinyereugo M. Umemneku Chikere, Kevin J. Wilson, A. Joy Allen and Luke Vale

    Citation: BMC Medical Research Methodology 2021 21:67

    Content type: Research article

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  32. Cancer patients’ prognoses are complicated by comorbidities. Prognostic prediction models with inappropriate comorbidity adjustments yield biased survival estimates. However, an appropriate claims-based comorb...

    Authors: Sanghee Lee, Yoon Jung Chang and Hyunsoon Cho

    Citation: BMC Medical Research Methodology 2021 21:66

    Content type: Research article

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  33. The best way to calculate statistics from medical data is to use the data of individual patients. In some settings, this data is difficult to obtain due to privacy restrictions. In Germany, for example, it is ...

    Authors: Stefan Lenz, Moritz Hess and Harald Binder

    Citation: BMC Medical Research Methodology 2021 21:64

    Content type: Technical advance

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  34. No standards exist for the handling and reporting of data quality in health research. This work introduces a data quality framework for observational health research data collections with supporting software i...

    Authors: Carsten Oliver Schmidt, Stephan Struckmann, Cornelia Enzenbach, Achim Reineke, Jürgen Stausberg, Stefan Damerow, Marianne Huebner, Börge Schmidt, Willi Sauerbrei and Adrian Richter

    Citation: BMC Medical Research Methodology 2021 21:63

    Content type: Research article

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  35. In case-control studies most algorithms allow the controls to be sampled several times, which is not always optimal. If many controls are available and adjustment for several covariates is necessary, matching ...

    Authors: Pavlos Mamouris, Vahid Nassiri, Geert Molenberghs, Marjan van den Akker, Joep van der Meer and Bert Vaes

    Citation: BMC Medical Research Methodology 2021 21:62

    Content type: Research article

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  36. Recruitment of general practitioners (GPs) and their patients is reported as one of the most challenging steps when undertaking primary care research. The present paper describes the recruitment process of a c...

    Authors: Sonia Lech, Julie L. O’Sullivan, Leonard Wellmann, Juliana Supplieth, Susanne Döpfmer, Paul Gellert, Adelheid Kuhlmey and Johanna Nordheim

    Citation: BMC Medical Research Methodology 2021 21:61

    Content type: Research article

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  37. The 2018 World Health Organization HIV guidelines were based on the results of a network meta-analysis (NMA) of published trials. This study employed individual patient-level data (IPD) and aggregate data (AgD...

    Authors: Steve Kanters, Mohammad Ehsanul Karim, Kristian Thorlund, Aslam H. Anis, Michael Zoratti and Nick Bansback

    Citation: BMC Medical Research Methodology 2021 21:60

    Content type: Research article

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  38. Randomized controlled trials in orthopaedics are powered to mainly find large effect sizes. A possible discrepancy between the estimated and the real mean difference is a challenge for statistical inference ba...

    Authors: Lauri Raittio, Antti Launonen, Ville M. Mattila and Aleksi Reito

    Citation: BMC Medical Research Methodology 2021 21:59

    Content type: Research article

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  39. Interrupted time series analysis is increasingly used to evaluate the impact of large-scale health interventions. While segmented regression is a common approach, it is not always adequate, especially in the p...

    Authors: Andrea L. Schaffer, Timothy A. Dobbins and Sallie-Anne Pearson

    Citation: BMC Medical Research Methodology 2021 21:58

    Content type: Technical advance

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  40. Estimation that employs instrumental variables (IV) can reduce or eliminate bias due to confounding. In observational studies, instruments result from natural experiments such as the effect of clinician prefer...

    Authors: Todd A. MacKenzie, Pablo Martinez-Camblor and A. James O’Malley

    Citation: BMC Medical Research Methodology 2021 21:56

    Content type: Research article

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  41. Cancer treatment is increasingly dependent on biomarkers for prognostication and treatment selection. Potential biomarkers are frequently evaluated in prospective-retrospective studies in which biomarkers are ...

    Authors: Wei Zhang, Zhiwei Zhang, Julia Krushkal and Aiyi Liu

    Citation: BMC Medical Research Methodology 2021 21:55

    Content type: Technical advance

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  42. Recruiting asymptomatic participants with early disease stages into studies is challenging and only little is known about facilitators and barriers to screening and recruitment of study participants. Thus we a...

    Authors: Jan Henrik Terheyden, Charlotte Behning, Anna Lüning, Ludmila Wintergerst, Pier G. Basile, Diana Tavares, Beatriz A. Melício, Sergio Leal, George Weissgerber, Ulrich F. O. Luhmann, David P. Crabb, Adnan Tufail, Carel Hoyng, Moritz Berger, Matthias Schmid, Rufino Silva…

    Citation: BMC Medical Research Methodology 2021 21:54

    Content type: Research article

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  43. Beginning in 2019, stepped-wedge designs (SWDs) were being used in the investigation of interventions to reduce opioid-related deaths in communities across the United States. However, these interventions are c...

    Authors: Lior Rennert, Moonseong Heo, Alain H. Litwin and Victor De Gruttola

    Citation: BMC Medical Research Methodology 2021 21:53

    Content type: Research article

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  44. Systematic Reviews (SRs) can build the groundwork for evidence-based health care decision-making. A sound methodological quality of SRs is crucial. AMSTAR (A Measurement Tool to Assess Systematic Reviews) is a...

    Authors: Stefanie Bühn, Peggy Ober, Tim Mathes, Uta Wegewitz, Anja Jacobs and Dawid Pieper

    Citation: BMC Medical Research Methodology 2021 21:51

    Content type: Research article

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  45. Outbreaks of infectious diseases generate outbreaks of scientific evidence. In 2016 epidemics of Zika virus emerged, and in 2020, a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused a p...

    Authors: Aziz Mert Ipekci, Diana Buitrago-Garcia, Kaspar Walter Meili, Fabienne Krauer, Nirmala Prajapati, Shabnam Thapa, Lea Wildisen, Lucia Araujo-Chaveron, Lukas Baumann, Sanam Shah, Tessa Whiteley, Gonzalo Solís-García, Foteini Tsotra, Ivan Zhelyazkov, Hira Imeri, Nicola Low…

    Citation: BMC Medical Research Methodology 2021 21:50

    Content type: Research article

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  46. Population segmentation permits the division of a heterogeneous population into relatively homogenous subgroups. This scoping review aims to summarize the clinical applications of data driven and expert driven...

    Authors: Jun Jie Benjamin Seng, Amelia Yuting Monteiro, Yu Heng Kwan, Sueziani Binte Zainudin, Chuen Seng Tan, Julian Thumboo and Lian Leng Low

    Citation: BMC Medical Research Methodology 2021 21:49

    Content type: Research article

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