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  1. In settings requiring synthetic data generation based on a clinical cohort, e.g., due to data protection regulations, heterogeneity across individuals might be a nuisance that we need to control or faithfully ...

    Authors: Kiana Farhadyar, Federico Bonofiglio, Maren Hackenberg, Max Behrens, Daniela Zöller and Harald Binder
    Citation: BMC Medical Research Methodology 2024 24:198
  2. In the context of clinical research, there is an increasing need for new study designs that help to incorporate already available data. With the help of historical controls, the existing information can be uti...

    Authors: Stephanie Wied, Martin Posch and Ralf-Dieter Hilgers
    Citation: BMC Medical Research Methodology 2024 24:197
  3. Systematic reviews and data synthesis of randomised clinical trials play a crucial role in clinical practice, research, and health policy. Trial sequential analysis can be used in systematic reviews to control...

    Authors: Christian Gunge Riberholt, Markus Harboe Olsen, Joachim Birch Milan, Sigurlaug Hanna Hafliðadóttir, Jeppe Houmann Svanholm, Elisabeth Buck Pedersen, Charles Chin Han Lew, Mark Aninakwah Asante, Johanne Pereira Ribeiro, Vibeke Wagner, Buddheera W. M. B. Kumburegama, Zheng-Yii Lee, Julie Perrine Schaug, Christina Madsen and Christian Gluud
    Citation: BMC Medical Research Methodology 2024 24:196
  4. Early identification of children at high risk of developing myopia is essential to prevent myopia progression by introducing timely interventions. However, missing data and measurement error (ME) are common ch...

    Authors: Hongyu Lai, Kaiye Gao, Meiyan Li, Tao Li, Xiaodong Zhou, Xingtao Zhou, Hui Guo and Bo Fu
    Citation: BMC Medical Research Methodology 2024 24:194
  5. Missing data are common in observational studies and often occur in several of the variables required when estimating a causal effect, i.e. the exposure, outcome and/or variables used to control for confoundin...

    Authors: Rheanna M. Mainzer, Margarita Moreno-Betancur, Cattram D. Nguyen, Julie A. Simpson, John B. Carlin and Katherine J. Lee
    Citation: BMC Medical Research Methodology 2024 24:193
  6. Many existing healthcare ranking systems are notably intricate. The standards for peer review and evaluation often differ across specialties, leading to contradictory results among various ranking systems. The...

    Authors: Xiaoling Peng, Moyuan Huang, Xinyang Li, Tianyi Zhou, Guiping Lin and Xiaoguang Wang
    Citation: BMC Medical Research Methodology 2024 24:192
  7. Handling missing data in clinical prognostic studies is an essential yet challenging task. This study aimed to provide a comprehensive assessment of the effectiveness and reliability of different machine learn...

    Authors: Imad El Badisy, Nathalie Graffeo, Mohamed Khalis and Roch Giorgi
    Citation: BMC Medical Research Methodology 2024 24:191
  8. Distributed statistical analyses provide a promising approach for privacy protection when analyzing data distributed over several databases. Instead of directly operating on data, the analyst receives anonymou...

    Authors: Daniel Schalk, Raphael Rehms, Verena S. Hoffmann, Bernd Bischl and Ulrich Mansmann
    Citation: BMC Medical Research Methodology 2024 24:190
  9. Accurate prediction of subject recruitment, which is critical to the success of a study, remains an ongoing challenge. Previous prediction models often rely on parametric assumptions which are not always met o...

    Authors: Villasante-Tezanos Alejandro, Yong-Fang Kuo, Kurinec Christopher, Li Yisheng and Xiaoying Yu
    Citation: BMC Medical Research Methodology 2024 24:189
  10. Comprehending the research dataset is crucial for obtaining reliable and valid outcomes. Health analysts must have a deep comprehension of the data being analyzed. This comprehension allows them to suggest pra...

    Authors: Marziyeh Afkanpour, Elham Hosseinzadeh and Hamed Tabesh
    Citation: BMC Medical Research Methodology 2024 24:188
  11. Real-world evidence is receiving considerable attention as a way to evaluate the efficacy and safety of medical products for substance use disorders (SUDs). However, the feasibility of using real-world data (R...

    Authors: Guneet S. Janda, Molly Moore Jeffery, Reshma Ramachandran, Joseph S. Ross and Joshua D. Wallach
    Citation: BMC Medical Research Methodology 2024 24:187
  12. According to long-term follow-up data of malignant tumor patients, assessing treatment effects requires careful consideration of competing risks. The commonly used cause-specific hazard ratio (CHR) and sub-dis...

    Authors: Haoning Shen, Chengfeng Zhang, Yu Song, Zhiheng Huang, Yanjie Wang, Yawen Hou and Zheng Chen
    Citation: BMC Medical Research Methodology 2024 24:186
  13. Digital mental health interventions (DMHIs) overcome traditional barriers enabling wider access to mental health support and allowing individuals to manage their treatment. How individuals engage with DMHIs im...

    Authors: Jack Elkes, Suzie Cro, Rachel Batchelor, Siobhan O’Connor, Ly-Mee Yu, Lauren Bell, Victoria Harris, Jacqueline Sin and Victoria Cornelius
    Citation: BMC Medical Research Methodology 2024 24:184
  14. While there is an interest in defining longitudinal change in people with chronic illness like Parkinson’s disease (PD), statistical analysis of longitudinal data is not straightforward for clinical researcher...

    Authors: Anne-Marie Hanff, Rejko Krüger, Christopher McCrum and Christophe Ley
    Citation: BMC Medical Research Methodology 2024 24:183
  15. Spillover of effect, whether positive or negative, from intervention to control group patients invalidates the Stable Unit Treatment Variable Assumption (SUTVA). SUTVA is critical to valid causal inference fro...

    Authors: James C. Hurley
    Citation: BMC Medical Research Methodology 2024 24:182
  16. Synthetic Electronic Health Records (EHRs) are becoming increasingly popular as a privacy enhancing technology. However, for longitudinal EHRs specifically, little research has been done into how to properly e...

    Authors: Jim L. Achterberg, Marcel R. Haas and Marco R. Spruit
    Citation: BMC Medical Research Methodology 2024 24:181
  17. There is a growing awareness of the need to adequately integrate sex and gender into health-related research. Although it is widely known that the entangled dimensions sex/gender are not comprehensively consid...

    Authors: Christina Hartig, Sophie Horstmann, Katharina Jacke, Ute Kraus, Lisa Dandolo, Alexandra Schneider, Kerstin Palm and Gabriele Bolte
    Citation: BMC Medical Research Methodology 2024 24:180
  18. Randomised, cluster-based study designs in schools are commonly used to evaluate children’s physical activity interventions. Sample size estimation relies on accurate estimation of the intra-cluster correlatio...

    Authors: Ruth Salway, Russell Jago, Frank de Vocht, Danielle House, Alice Porter, Robert Walker, Ruth Kipping, Christopher G. Owen, Mohammed T. Hudda, Kate Northstone and Esther van Sluijs
    Citation: BMC Medical Research Methodology 2024 24:179
  19. Statistical regression models are used for predicting outcomes based on the values of some predictor variables or for describing the association of an outcome with predictors. With a data set at hand, a regres...

    Authors: Georg Heinze, Mark Baillie, Lara Lusa, Willi Sauerbrei, Carsten Oliver Schmidt, Frank E. Harrell and Marianne Huebner
    Citation: BMC Medical Research Methodology 2024 24:178
  20. Appropriately defining and using the minimal important change (MIC) and the minimal clinically important difference (MCID) are crucial for determining whether the results are clinically significant. The aim of...

    Authors: Zongshi Qin, Yidan Zhu, Dong-Dong Shi, Rumeng Chen, Sen Li and Jiani Wu
    Citation: BMC Medical Research Methodology 2024 24:177
  21. Prediction models are often externally validated with data from a single study or cohort. However, the interpretation of performance estimates obtained with single-study external validation is not as straightf...

    Authors: Jordi de Winkel, Carolien C. H. M. Maas, Bob Roozenbeek, David van Klaveren and Hester F. Lingsma
    Citation: BMC Medical Research Methodology 2024 24:176
  22. Childhood stunting is a major indicator of child malnutrition and a focus area of Global Nutrition Targets for 2025 and Sustainable Development Goals. Risk factors for childhood stunting are well studied and w...

    Authors: Jonathan Mkungudza, Halima S. Twabi and Samuel O. M. Manda
    Citation: BMC Medical Research Methodology 2024 24:175
  23. Simulation is an important tool for assessing the performance of statistical methods for the analysis of data and for the planning of studies. While methods are available for the simulation of correlated binar...

    Authors: Rhys A. Bowden, Jessica Kasza and Andrew B. Forbes
    Citation: BMC Medical Research Methodology 2024 24:174
  24. In order to facilitate the tracing of infectious diseases in a small area and to effectively carry out disease control and epidemiological investigations, this research proposes a novel spatiotemporal model to...

    Authors: Linyi Wang, Yue Wu, Yin He and Yu Zhang
    Citation: BMC Medical Research Methodology 2024 24:173
  25. We have introduced the R package jmBIG to facilitate the analysis of large healthcare datasets and the development of predictive models. This package provides a comprehensive set of tools and functions specifi...

    Authors: Atanu Bhattacharjee, Bhrigu Kumar Rajbongshi and Gajendra K. Vishwakarma
    Citation: BMC Medical Research Methodology 2024 24:172
  26. Dimension reduction methods do not always reduce their underlying indicators to a single composite score. Furthermore, such methods are usually based on optimality criteria that require discarding some informa...

    Authors: Siamak Noorbaloochi, Barbara A. Clothier and Maureen Murdoch
    Citation: BMC Medical Research Methodology 2024 24:171
  27. Wolbachia symbiosis in Aedes aegypti is an emerging biocontrol measure against dengue. However, assessing its real-world efficacy is challenging due to the non-randomised, field-based nature of most intervention ...

    Authors: Jo Yi Chow, Lin Geng, Somya Bansal, Borame Sue Lee Dickens, Lee Ching Ng, Ary Anthony Hoffmann and Jue Tao Lim
    Citation: BMC Medical Research Methodology 2024 24:170
  28. Although aggregate data (AD) from randomised clinical trials (RCTs) are used in the majority of network meta-analyses (NMAs), other study designs (e.g., cohort studies and other non-randomised studies, NRS) ca...

    Authors: Tasnim Hamza, Guido Schwarzer and Georgia Salanti
    Citation: BMC Medical Research Methodology 2024 24:169
  29. Understanding the complex interactions between genes and their causal effects on diseases is crucial for developing targeted treatments and gaining insight into biological mechanisms. However, the analysis of ...

    Authors: Jack Kelly, Xiaoguang Xu, James M. Eales, Bernard Keavney, Carlo Berzuini, Maciej Tomaszewski and Hui Guo
    Citation: BMC Medical Research Methodology 2024 24:168
  30. Pocock-Simon’s minimisation method has been widely used to balance treatment assignments across prognostic factors in randomised controlled trials (RCTs). Previous studies focusing on the survival outcomes hav...

    Authors: Ryusei Kimura, Shogo Nomura, Kengo Nagashima and Yasunori Sato
    Citation: BMC Medical Research Methodology 2024 24:166
  31. Standard systematic review can be labor-intensive and time-consuming meaning that it can be difficult to provide timely evidence when there is an urgent public health emergency such as a pandemic. The Clinical...

    Authors: Tianqi Yu, Xi Yang, Justin Clark, Lifeng Lin, Luis Furuya-Kanamori and Chang Xu
    Citation: BMC Medical Research Methodology 2024 24:165
  32. The research on sodium-glucose cotransporter 2 (SGLT2) inhibitors has been increasing rapidly in the last decade, as well as indications for their use. This study aimed to analyze the methodological characteri...

    Authors: Fran Šaler, Marin Viđak and Livia Puljak
    Citation: BMC Medical Research Methodology 2024 24:164
  33. Systematic reviews and meta-analyses are essential tools in contemporary evidence-based medicine, synthesizing evidence from various sources to better inform clinical decision-making. However, the conclusions ...

    Authors: Wenshan Han, Zheng Wang, Mengli Xiao, Zhe He, Haitao Chu and Lifeng Lin
    Citation: BMC Medical Research Methodology 2024 24:162
  34. Lack of diversity in participants throughout the research process limits the generalizability of findings and may contribute to health disparities. There are unique challenges to recruitment of families to ped...

    Authors: Carolyn R. Bates, Renee M. Gilbert, Kelsey M. Dean, Keith J. August, Christie A. Befort, Shallyn Ward, Mary Gibson and Meredith L. Dreyer Gillette
    Citation: BMC Medical Research Methodology 2024 24:161
  35. POINCARE-2 trial aimed to assess the effectiveness of a strategy designed to tackle fluid overload through daily weighing and subsequent administration of treatments in critically ill patients. Even in highly ...

    Authors: Marie Buzzi, Laetitia Ricci, Sébastien Gibot, Laurent Argaud, Julio Badie, Cédric Bruel, Claire Charpentier, Hervé Outin, Guillaume Louis, Alexandra Monnier, Jean-Pierre Quenot, Francis Schneider, Laetitia Minary and Nelly Agrinier
    Citation: BMC Medical Research Methodology 2024 24:160
  36. In randomized clinical trials, treatment effects may vary, and this possibility is referred to as heterogeneity of treatment effect (HTE). One way to quantify HTE is to partition participants into subgroups ba...

    Authors: Edward Xu, Joseph Vanghelof, Yiyang Wang, Anisha Patel, Jacob Furst, Daniela Stan Raicu, Johannes Tobias Neumann, Rory Wolfe, Caroline X. Gao, John J. McNeil, Raj C. Shah and Roselyne Tchoua
    Citation: BMC Medical Research Methodology 2024 24:158
  37. Network analysis, commonly used to describe the patterns of multimorbidity, uses the strength of association between conditions as weight to classify conditions into communities and calculate centrality statis...

    Authors: Mohammad Reza Baneshi, Annette Dobson and Gita D. Mishra
    Citation: BMC Medical Research Methodology 2024 24:157
  38. Authors: Soledad Munoz‑Ramirez, Begona Escribano‑Lopez, Vallivana Rodrigo‑Casares, Carlos Vergara‑Hernandez, Desamparados Gil‑Mary, Ignacio Sorribes‑Monrabal, Maria Garces‑Sanchez, Maria‑Jesus Munoz‑Del‑Barrio, Ana‑Maria Albors‑Fernandez, Maria‑Isabel Ubeda‑Sansano, Maria‑Victoria Planelles‑Cantarino, Ester‑Maria Largo‑blanco, Eva Suarez‑Vicent, Javier Garcia‑Rubio, Patricia Bruijning‑Verhagen, Alejandro Orrico‑Sanchez…
    Citation: BMC Medical Research Methodology 2024 24:156

    The original article was published in BMC Medical Research Methodology 2021 21:273

  39. There is increasing interest in the capacity of adaptive designs to improve the efficiency of clinical trials. However, relatively little work has investigated how economic considerations – including the costs...

    Authors: Charlie Welch, Martin Forster, Sarah Ronaldson, Ada Keding, Belen Corbacho-Martín and Puvan Tharmanathan
    Citation: BMC Medical Research Methodology 2024 24:155
  40. Engaging researchers as research subjects is key to informing the development of effective and relevant research practices. It is important to understand how best to engage researchers as research subjects.

    Authors: Elizabeth R. Stevens, Charles M. Cleland, Amelia Shunk and Omar El Shahawy
    Citation: BMC Medical Research Methodology 2024 24:153
  41. When different researchers study the same research question using the same dataset they may obtain different and potentially even conflicting results. This is because there is often substantial flexibility in ...

    Authors: Maximilian M. Mandl, Andrea S. Becker-Pennrich, Ludwig C. Hinske, Sabine Hoffmann and Anne-Laure Boulesteix
    Citation: BMC Medical Research Methodology 2024 24:152
  42. The test-negative design (TND) is an observational study design to evaluate vaccine effectiveness (VE) that enrolls individuals receiving diagnostic testing for a target disease as part of routine care. VE is ...

    Authors: Yanan Huo, Yang Yang, M. Elizabeth Halloran, Ira M. Longini Jr. and Natalie E. Dean
    Citation: BMC Medical Research Methodology 2024 24:151
  43. Effectiveness in health care is a specific characteristic of each intervention and outcome evaluated. Especially with regard to surgical interventions, organization, structure and processes play a key role in ...

    Authors: Arianna Scala, Teresa Angela Trunfio and Giovanni Improta
    Citation: BMC Medical Research Methodology 2024 24:150
  44. Throughout the Covid-19 pandemic, researchers have made use of electronic health records to research this disease in a rapidly evolving environment of questions and discoveries. These studies are prone to coll...

    Authors: Annastazia Learoyd, Jennifer Nicholas, Nicholas Hart and Abdel Douiri
    Citation: BMC Medical Research Methodology 2024 24:149

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