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  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. 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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  8. 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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  9. 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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  10. 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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  11. 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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  12. 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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  13. 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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  14. 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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  15. 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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  16. 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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  17. 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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  18. Royston-Parmar flexible parametric survival models (FPMs) can be fitted on either the cause-specific hazards or cumulative incidence scale in the presence of competing risks. An advantage of modelling within t...

    Authors: Sarwar I. Mozumder, Mark J. Rutherford and Paul C. Lambert

    Citation: BMC Medical Research Methodology 2021 21:52

    Content type: Research article

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  19. 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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  20. 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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  21. 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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  22. We propose a new measure of treatment effect based on the expected reduction in the number of patients to treat (RNT) which is defined as the difference of the reciprocals of clinical measures of interest betw...

    Authors: Chenyang Zhang and Guosheng Yin

    Citation: BMC Medical Research Methodology 2021 21:48

    Content type: Research article

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  23. Waist circumference is becoming recognized as a useful predictor of health risks in clinical research. However, clinical datasets tend to lack this measurement and self-reported values tend to be inaccurate. P...

    Authors: Weihong Zhou, Spencer Eckler, Andrew Barszczyk, Alex Waese-Perlman, Yingjie Wang, Xiaoping Gu, Zhong-Ping Feng, Yuzhu Peng and Kang Lee

    Citation: BMC Medical Research Methodology 2021 21:47

    Content type: Technical advance

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  24. This study investigated the ArmA-TH sub-scale measurement properties based on item response theory using the Rasch model.

    Authors: Montana Buntragulpoontawee, Jeeranan Khunachiva, Patreeya Euawongyarti, Nahathai Wongpakaran, Tinakon Wongpakaran, Atcharee Kaewma and Stephen Ashford

    Citation: BMC Medical Research Methodology 2021 21:46

    Content type: Research article

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  25. The results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that ...

    Authors: Kari Kanto, Tuomas Lähdeoja, Mika Paavola, Pasi Aronen, Teppo L. N. Järvinen, Jarkko Jokihaara, Clare L. Ardern, Teemu V. Karjalainen and Simo Taimela

    Citation: BMC Medical Research Methodology 2021 21:45

    Content type: Research article

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  26. Racial and ethnic minorities are often underrepresented in clinical trials, threatening the generalizability of trial results. Several factors may contribute to underrepresentation of minorities in clinical tr...

    Authors: Sheila V. Kusnoor, Victoria Villalta-Gil, Margo Michaels, Yvonne Joosten, Tiffany L. Israel, Marcia I. Epelbaum, Patricia Lee, Elizabeth T. Frakes, Jennifer Cunningham-Erves, Stephanie A. Mayers, Sarah C. Stallings, Nunzia B. Giuse, Paul A. Harris and Consuelo H. Wilkins

    Citation: BMC Medical Research Methodology 2021 21:44

    Content type: Research article

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  27. The case-crossover design is suited to medication safety studies but is vulnerable to exposure misclassification. Using the example of tricyclic antidepressants and the risk of hip fracture, we present a data ...

    Authors: Michael J. Leach, Elizabeth E. Roughead and Nicole L. Pratt

    Citation: BMC Medical Research Methodology 2021 21:43

    Content type: Technical advance

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  28. The COVID-19 pandemic continues to rage on, and clinical research has been promoted worldwide. We aimed to assess the clinical and methodological characteristics of treatment clinical trials that have been set...

    Authors: Beatrice Mainoli, Tiago Machado, Gonçalo S. Duarte, Luísa Prada, Nilza Gonçalves, Joaquim J. Ferreira and João Costa

    Citation: BMC Medical Research Methodology 2021 21:42

    Content type: Research article

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  29. Clinical interpretation of changes measured on a scale is dependent on knowing the minimum clinically important difference (MCID) for that scale: the threshold above which clinicians, patients, and researchers...

    Authors: Jennifer A. Watt, Areti Angeliki Veroniki, Andrea C. Tricco and Sharon E. Straus

    Citation: BMC Medical Research Methodology 2021 21:41

    Content type: Research article

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  30. Dynamic treatment regimens (DTRs) formalise the multi-stage and dynamic decision problems that clinicians often face when treating chronic or progressive medical conditions. Compared to randomised controlled t...

    Authors: Robert K. Mahar, Myra B. McGuinness, Bibhas Chakraborty, John B. Carlin, Maarten J. IJzerman and Julie A. Simpson

    Citation: BMC Medical Research Methodology 2021 21:39

    Content type: Research article

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  31. Data collection is the most critical stage in any population health study and correctly implementing fieldwork enhances the quality of collected information. However, even the most carefully planned large-scal...

    Authors: Mir Baz Khan, Sidrah Nausheen, Imtiaz Hussain, Kristy Hackett, Kaneez Zehra, Khalid Feroze, David Canning, Iqbal Shah and Sajid Bashir Soofi

    Citation: BMC Medical Research Methodology 2021 21:38

    Content type: Research article

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  32. Most health surveys have experienced a decline in response rates. A structured approach to evaluate whether a decreasing - and potentially more selective - response over time biased estimated trends in health ...

    Authors: Famke J. M. Mölenberg, Chris de Vries, Alex Burdorf and Frank J. van Lenthe

    Citation: BMC Medical Research Methodology 2021 21:37

    Content type: Research article

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  33. Time-to-event data that is subject to interval censoring is common in the practice of medical research and versatile statistical methods for estimating associations in such settings have been limited. For righ...

    Authors: Martin Nygård Johansen, Søren Lundbye-Christensen, Jacob Moesgaard Larsen and Erik Thorlund Parner

    Citation: BMC Medical Research Methodology 2021 21:36

    Content type: Technical advance

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  34. Randomized controlled trials are considered the gold standard to evaluate causal associations, whereas assessing causality in observational studies is challenging.

    Authors: Emilia Gvozdenović, Lucio Malvisi, Elisa Cinconze, Stijn Vansteelandt, Phoebe Nakanwagi, Emmanuel Aris and Dominique Rosillon

    Citation: BMC Medical Research Methodology 2021 21:35

    Content type: Research article

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  35. Ensemble modeling aims to boost the forecasting performance by systematically integrating the predictive accuracy across individual models. Here we introduce a simple-yet-powerful ensemble methodology for fore...

    Authors: Gerardo Chowell and Ruiyan Luo

    Citation: BMC Medical Research Methodology 2021 21:34

    Content type: Research article

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  36. To evaluate the completeness of reporting abstracts of systematic reviews (SRs) before and after the publication of the PRISMA-A checklist in 2013 and to assess if an association exists between abstract charac...

    Authors: Milagros Adobes Martin, Sala Santamans Faustino, Inmaculada Llario Almiñana, Riccardo Aiuto, Roberto Rotundo and Daniele Garcovich

    Citation: BMC Medical Research Methodology 2021 21:33

    Content type: Research article

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  37. Natural or quasi experiments are appealing for public health research because they enable the evaluation of events or interventions that are difficult or impossible to manipulate experimentally, such as many p...

    Authors: Frank de Vocht, Srinivasa Vittal Katikireddi, Cheryl McQuire, Kate Tilling, Matthew Hickman and Peter Craig

    Citation: BMC Medical Research Methodology 2021 21:32

    Content type: Technical advance

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  38. Scale-up BP was a quasi-experimental implementation study, following a successful randomised controlled trial of the roll-out of telemonitoring in primary care across Lothian, Scotland. Our primary objective w...

    Authors: Richard A. Parker, Paul Padfield, Janet Hanley, Hilary Pinnock, John Kennedy, Andrew Stoddart, Vicky Hammersley, Aziz Sheikh and Brian McKinstry

    Citation: BMC Medical Research Methodology 2021 21:31

    Content type: Research article

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  39. In infectious disease transmission dynamics, the high heterogeneity in individual infectiousness indicates that few index cases generate large numbers of secondary cases, which is commonly known as superspread...

    Authors: Shi Zhao, Mingwang Shen, Salihu S. Musa, Zihao Guo, Jinjun Ran, Zhihang Peng, Yu Zhao, Marc K. C. Chong, Daihai He and Maggie H. Wang

    Citation: BMC Medical Research Methodology 2021 21:30

    Content type: Research article

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  40. Statistical methods for modeling longitudinal and time-to-event data has received much attention in medical research and is becoming increasingly useful. In clinical studies, such as cancer and AIDS, longitudi...

    Authors: Julius S. Ngwa, Howard J. Cabral, Debbie M. Cheng, David R. Gagnon, Michael P. LaValley and L. Adrienne Cupples

    Citation: BMC Medical Research Methodology 2021 21:29

    Content type: Research article

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  41. COVID-19 has led to the adoption of unprecedented mitigation measures which could trigger many unintended consequences. These unintended consequences can be far-reaching and just as important as the intended o...

    Authors: Anne-Marie Turcotte-Tremblay, Idriss Ali Gali Gali and Valéry Ridde

    Citation: BMC Medical Research Methodology 2021 21:28

    Content type: Commentary

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  42. Ethnographic approaches offer a method and a way of thinking about implementation. This manuscript applies a specific case study method to describe the impact of the longitudinal interplay between implementati...

    Authors: Jennifer M. Van Tiem, Heather Schacht Reisinger, Julia E. Friberg, Jaime R. Wilson, Lynn Fitzwater, Ralph J. Panos and Jane Moeckli

    Citation: BMC Medical Research Methodology 2021 21:27

    Content type: Research article

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  43. Over 2 billion people suffer from vision impairment or blindness globally, and access to validated visual measurement tools in imperative in accurately describing and managing the burden of eye disease. The pr...

    Authors: William Mitchell, Srinivas Marmamula, Nazlee Zebardast, Weiwen Ng, Joseph J. Locascio, Thirupathi Kumbam, Satya Brahmanandam and Navya Rekha Barrenkala

    Citation: BMC Medical Research Methodology 2021 21:26

    Content type: Research article

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  44. Many respondent-driven sampling (RDS) methodologies have been employed to investigate hard-to-reach populations; however, these methodologies present some limits. We describe a minimally investigated RDS metho...

    Authors: Maxime Inghels, Arsène Kra Kouassi, Serge Niangoran, Anne Bekelynck, Séverine Carillon, Lazare Sika, Mariatou Koné, Christine Danel, Annabel Desgrées du Loû and Joseph Larmarange

    Citation: BMC Medical Research Methodology 2021 21:25

    Content type: Research article

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  45. Early pregnancy weights are needed to quantify gestational weight gain accurately. Different methods have been used in previous studies to impute early-pregnancy weights. However, no studies have systematicall...

    Authors: Jiaxi Yang, Dongqing Wang, Anne Marie Darling, Enju Liu, Nandita Perumal, Wafaie W. Fawzi and Molin Wang

    Citation: BMC Medical Research Methodology 2021 21:24

    Content type: Research article

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  46. Trials of novel agents are required to improve the care of patients with rare diseases, but trial feasibility may be uncertain due to concerns over insufficient patient numbers. We aimed to determine the size ...

    Authors: M. S. M. Persson, K. E. Harman, K. S. Thomas, J. R. Chalmers, Y. Vinogradova, S. M. Langan, J. Hippisley-Cox and S. Gran

    Citation: BMC Medical Research Methodology 2021 21:22

    Content type: Research article

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