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Articles

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  1. In cardiovascular (CV) trials, analyzing the total number of events, rather than just time-to-first event, enhances understanding of participants' health. Adapting Cox models to account for between-subject het...

    Authors: Shun-Fu Lee, Chinthanie Ramasundarahettige, Hertzel C. Gerstein, William F. McIntyre, John Eikelboom, Martin J. O’Donnell, Yueci Zhou, Shrikant I. Bangdiwala and Lehana Thabane
    Citation: BMC Medical Research Methodology 2025 25:159
  2. To develop a Chinese visual analogue scale (VAS) value set for Europe Quality of Life Questionnaire (EQ-5D-3L) and compare it with the time trade-off (TTO) value set which was constructed based on the same sam...

    Authors: Lin Zhuo, Siyuan Gao, Rui Jin, Lang Zhuo and Xiuying Wang
    Citation: BMC Medical Research Methodology 2025 25:158
  3. Difference in Restricted Mean Survival Time (DRMST) has attracted attention and is increasingly used in non-inferiority (NI) trials because of its superior power in detecting treatment effects compared to haza...

    Authors: Austin Shih, Chih-Yuan Hsu and Yu Shyr
    Citation: BMC Medical Research Methodology 2025 25:157
  4. Whilst interest in efficient trial design has grown with the use of electronic health records (EHRs) to collect trial outcomes, practical challenges remain. Commonly raised concerns often revolve around data a...

    Authors: Ariel Wang, Anna E Seeley, Matthew R Sydes, Nicholas Jones, Simon de Lusignan, FD Richard Hobbs, Richard J McManus, Marney Williams and James P Sheppard
    Citation: BMC Medical Research Methodology 2025 25:156
  5. Accumulating evidence demonstrates that miRNAs exhibit enhanced diagnostic sensitivity and specificity compared to the conventional hepatocellular carcinoma (HCC) biomarker alpha-fetoprotein (AFP), particularl...

    Authors: Shuaiyang Wang, Mei Wu, Bei Xie, Xingyuan Ma, Jing Li, Bin Ma and Linjing Li
    Citation: BMC Medical Research Methodology 2025 25:155
  6. Identifying and understanding disease risk factors is crucial in epidemiology, particularly for chronic and noncommunicable diseases that often have complex interrelationships. Traditional statistical methods ...

    Authors: Yuanyuan Zhao and Jinzhu Jia
    Citation: BMC Medical Research Methodology 2025 25:154
  7. Value-adaptive designs for clinical trials are a novel set of emerging methods for delivering greater value for clinical research. There is increasing interest in using them within publicly funded health syste...

    Authors: Laura Flight, Alan Brennan, Stephen E. Chick, Martin Forster, Steven Julious and Puvan Tharmanathan
    Citation: BMC Medical Research Methodology 2025 25:153
  8. There is still demand for algorithms that can be used at the point of care, especially when dealing with events that do not present with a single obvious clinical indicator. The Spiegelhalter-Knill-Jones (SKJ)...

    Authors: Bart K. M. Jacobs, Tafadzwa Maseko, Lutgarde Lynen, Aquiles Rodrigo Henriquez-Trujillo and Jozefien Buyze
    Citation: BMC Medical Research Methodology 2025 25:152
  9. Gold standards used in validation of new tests may be imperfect, with sensitivity or specificity less than 100%. The impact of imperfection in a gold standard on measured test attributes has been demonstrated ...

    Authors: Mark S. Walker, Lukas Slipski and Yanina Natanzon
    Citation: BMC Medical Research Methodology 2025 25:151
  10. With the rise of large language models, the application of artificial intelligence in research is expanding, possibly accelerating specific stages of the research processes. This study aims to compare the accu...

    Authors: Kim Nordmann, Stefanie Sauter, Mirjam Stein, Johanna Aigner, Marie-Christin Redlich, Michael Schaller and Florian Fischer
    Citation: BMC Medical Research Methodology 2025 25:150
  11. Multiple treatment options frequently exist for a single medical condition with no single standard of care (SoC), rendering a classic randomised trial comparing a specific treatment to a control treatment infe...

    Authors: Holly Jackson, Yiyun Shou, Nur Amira Binte Mohamed Azad, Jing Wen Chua, Rebecca Lynn Perez, Xinru Wang, Marlieke E. A. de Kraker and Yin Mo
    Citation: BMC Medical Research Methodology 2025 25:149
  12. This article describes how withdrawals and exclusions of study participants can be managed in COVID-19-cohort studies by NUKLEUS (German: NUM Klinische Epidemiologie- und Studienplattform), using NAPKON (Germa...

    Authors: Heike Valentin, Henriette Rau, Lizon Fiedler-Lacombe, Arne Blumentritt, Ekaterina Heim, Alexander Rudolph, Katrin Leyh, Monika Kraus, Bettina Lorenz-Depiereux, Irina Chaplinskaya, Christian Schäfer, Jens Schaller, Joerg Janne Vehreschild, Melanie Stecher, Margarete Scherer, Martin Witzenrath…
    Citation: BMC Medical Research Methodology 2025 25:148
  13. Most diagnostic accuracy studies have applied a complete case analysis (CCA) or single imputation approach to address missing values in the index test, which may lead to biased results. Therefore, this simulat...

    Authors: Katharina Stahlmann, Bastiaan Kellerhuis, Johannes B. Reitsma, Nandini Dendukuri and Antonia Zapf
    Citation: BMC Medical Research Methodology 2025 25:147
  14. The widespread use of long-term pharmacological treatments for chronic conditions has led to polypharmacy, raising concerns about adverse effects and interactions. Deprescribing, the discontinuation of drugs w...

    Authors: Nele Kornder, Norbert Donner-Banzhoff, Ina Staudt, Nina Grede, Annette Becker and Annika Viniol
    Citation: BMC Medical Research Methodology 2025 25:146
  15. Population-based, age-standardized net survival estimates provide valuable insights for comparing the effectiveness of cancer treatment and the prospects of cure in an international context. Although numerous ...

    Authors: András Wéber, Zoltán Vokó, Zoltán Kiss, István Szatmári, Mária Dobozi, Petra Parrag, Ibolya Fábián, György Rokszin, Péter Nagy, Csaba Polgár and István Kenessey
    Citation: BMC Medical Research Methodology 2025 25:145
  16. In biomedical research, the calculation of sample size is a critical component of study design. Adequate sample size ensures the reliability of statistical tests, including the chi-square test. This manuscript...

    Authors: Hanif Abdul Rahman, ⁠Amirul Ariffin Noraidi, ⁠Amal Nadhirah Hj Khalid, ⁠Alanna Zawani Mohamad-Adam, Nurrabiatul Haziqah Zahari and Nurezzah Ezzaty Tuming
    Citation: BMC Medical Research Methodology 2025 25:144
  17. In a wide range of diseases, it is necessary to utilize multiple data sources to obtain enough data for model training. However, performing centralized pooling of multiple data sources, while protecting each p...

    Authors: Rasmus Rask Kragh Jørgensen, Jonas Faartoft Jensen, Tarec El-Galaly, Martin Bøgsted, Rasmus Froberg Brøndum, Mikkel Runason Simonsen and Lasse Hjort Jakobsen
    Citation: BMC Medical Research Methodology 2025 25:143
  18. Evaluating recurrent events within a time-to-event analysis framework effectively utilizes all relevant information to address the clinical question of interest fully and has certain advantages in randomized c...

    Authors: Chen Shi, Jia-Wei Wei, Zi-Shu Zhan, Xiao-Han Xu, Ze-Lin Yan and Chun-Quan Ou
    Citation: BMC Medical Research Methodology 2025 25:142
  19. The standard regulatory approach to assess replication success is the two-trials rule, requiring both the original and the replication study to be significant with effect estimates in the same direction. The s...

    Authors: Jeanette Köppe, Charlotte Micheloud, Stella Erdmann, Rachel Heyard and Leonhard Held
    Citation: BMC Medical Research Methodology 2025 25:141
  20. Sharing clinical study data is endorsed by many funders and journals, international policy frameworks, and patients. Reuse of clinical study data demonstrably improves health research, and emerging technologie...

    Authors: Evgeny Bobrov, Christina Habermehl, Daniel Strech, Tracey Weissgerber and René Bernard
    Citation: BMC Medical Research Methodology 2025 25:140
  21. Time-to-event data is commonly used in non-inferiority clinical trials. While the hazard ratio is a popular summary measure in this context, the difference in restricted mean survival time has been theoretical...

    Authors: S. D. Lana Broer, Ian R. White, Tim P. Morris, Isabelle R. Weir, Marta Fiocco and Matteo Quartagno
    Citation: BMC Medical Research Methodology 2025 25:139
  22. Codelists play a crucial role in ensuring accurate and standardized communication within healthcare. However, preparation of high-quality codelists is a rigorous and time-consuming process. The literature focu...

    Authors: A. Aslam, L. Walker, M. Abaho, H. Cant, M. O’Connell, A. S. Abuzour, L. Hama, P. Schofield, F. S. Mair, R. A. Ruddle, O. Popoola, M. Sperrin, J. Y. Tsang, E. Shantsila, M. Gabbay, A. Clegg…
    Citation: BMC Medical Research Methodology 2025 25:138
  23. Herein we coin the terms non-Markovian error and biased Markovian error to describe categories of scientific errors for which general progress within a field of study may be unlikely to result in scientific self-...

    Authors: Jon Agley, Sarah E. Deemer and David B. Allison
    Citation: BMC Medical Research Methodology 2025 25:137
  24. Many segments of the population are underrepresented in biomedical research (UBR). Lack of diversity in health research limits understanding of individual and population level differences and risks the general...

    Authors: Lauren O. Thomann, Katherine A. Hanson, Jane Plomp, Jason L. Vassy and Sherilyn J. Sawyer
    Citation: BMC Medical Research Methodology 2025 25:136
  25. Understanding dose-response relationships is crucial in optimizing clinical outcomes, particularly in complex interventions such as psychotherapy. While dose-response research is common in pharmaceutical conte...

    Authors: Mollie Payne, Dominic Stringer, Ben Carter, Amy Hardy and Richard Emsley
    Citation: BMC Medical Research Methodology 2025 25:135
  26. Supervised machine learning is increasingly being used to estimate clinical predictive models. Several supervised machine learning models involve hyper-parameters, whose values must be judiciously specified to...

    Authors: Christopher Meaney, Xuesong Wang, Jun Guan and Therese A. Stukel
    Citation: BMC Medical Research Methodology 2025 25:134
  27. Consolidation of treatment effects from randomized controlled trials (RCT) is considered one of the highest forms of evidence in research. Cluster randomized trials (CRT) are increasingly used in the assessmen...

    Authors: Joseph Alvin Ramos Santos, Emilia Riggi and Gian Luca Di Tanna
    Citation: BMC Medical Research Methodology 2025 25:133
  28. Finite mixture models have been recently applied in time-to-event data to identify subgroups with distinct hazard functions, yet they often assume differing covariate effects on failure times across latent cla...

    Authors: Fu-Wen Liang, Wenyaw Chan, Michael D. Swartz and Bouthaina S. Dabaja
    Citation: BMC Medical Research Methodology 2025 25:132
  29. Indirect treatment comparisons can provide evidence of relative efficacy for novel therapies when implementation of a randomised controlled trial is infeasible. However, such comparisons are vulnerable to unme...

    Authors: Steven Soutar, Amy Macdougall, Jamie Wallis, Joseph E. O’Reilly and Lewis Carpenter
    Citation: BMC Medical Research Methodology 2025 25:131
  30. Systematic reviews (SRs) are essential to formulate evidence-based guidelines but require time-consuming and costly literature screening. Large Language Models (LLMs) can be a powerful tool to expedite SRs.

    Authors: Fouad Trad, Ryan Yammine, Jana Charafeddine, Marlene Chakhtoura, Maya Rahme, Ghada El-Hajj Fuleihan and Ali Chehab
    Citation: BMC Medical Research Methodology 2025 25:130
  31. The demand for rehabilitation services is rising due to the aging population and increasing number of chronic conditions. High-quality research is essential to address these challenges, with recent mandates em...

    Authors: Ahmed Elghzali, Daniel Molina, Mahad Chaudhry, Jacob Duncan, Annes Elfar, Eli Oldham, Brody Dennis, Eli Paul, Alicia Ito Ford and Matt Vassar
    Citation: BMC Medical Research Methodology 2025 25:129
  32. The Cass Review aimed to provide recommendations for the delivery of services for gender diverse children and young people in England. The final product of this project, the Cass report, relied on commissioned...

    Authors: Chris Noone, Alex Southgate, Alex Ashman, Éle Quinn, David Comer, Duncan Shrewsbury, Florence Ashley, Jo Hartland, Joanna Paschedag, John Gilmore, Natacha Kennedy, Thomas E. Woolley, Rachel Heath, Ryan Goulding, Victoria Simpson, Ed Kiely…
    Citation: BMC Medical Research Methodology 2025 25:128
  33. Staircase designs are incomplete stepped wedge designs that, unlike standard stepped wedge designs, require clusters to contribute data for only a limited number of trial periods. Previous work has provided fo...

    Authors: Ehsan Rezaei-Darzi, Kelsey L. Grantham, Andrew B. Forbes and Jessica Kasza
    Citation: BMC Medical Research Methodology 2025 25:127
  34. Vulnerable subgroups of the population, such as care home residents, often face elevated mortality risks during crises like pandemics or wars. To correctly model and interpret the excess mortality of vulnerabl...

    Authors: Marije H. Sluiskes, Eva A. S. Koster, Jelle J. Goeman, Mar Rodríguez-Girondo, Hein Putter and Liesbeth C. de Wreede
    Citation: BMC Medical Research Methodology 2025 25:126
  35. To perform a quantitative and qualitative analysis of spin bias in randomized clinical trials (RCTs) focusing on botulinum toxin (BTX-A) for managing bruxism.

    Authors: Graziela De Luca Canto, Patrícia Pauletto, Cristine Miron Stefani, Thais Marques Simek Vega Gonçalves, Nelson Carvas Junior, Carlos Flores-Mir, Ana Carolina Pereira Nunes Pinto and Virginia Fernandes Moça Trevisani
    Citation: BMC Medical Research Methodology 2025 25:125
  36. Restricted mean survival time (RMST) quantifies survival benefits in single-endpoint analysis, while restricted mean time lost (RMTL) measures event-related time loss in competing risks settings. Both provide ...

    Authors: Shuyu Chen, Mengyao Wang, Xingyou Zhou, Wenbin Zhang, Chengfeng Zhang and Zheng Chen
    Citation: BMC Medical Research Methodology 2025 25:123
  37. Diverse populations are more exposed to life course influences on adverse ageing, including brain ageing. Research into dementia in the United Kingdom inadvertently lacks diversity. Therefore, there is a need ...

    Authors: Katrina Messiha, Nicole Thomas, C. Brayne, D. M. Agnello, L. Delfmann, M. Giné-Garriga, S. Lippke and J. Downey
    Citation: BMC Medical Research Methodology 2025 25:122
  38. REFRACT is a randomised trial aimed at rapidly evaluating multiple novel therapies against standard treatment for relapsed or refractory follicular lymphoma (rrFL) using a minimal number of patients. To this e...

    Authors: Charlotte Gaskell, Kim Linton, Mark Bishton, Graham McIlroy, Siân Lax, Sonia Fox, Louise Hopkins, Rebecca Collings, Malcolm Rhodes, Tania Seale and Aimee Jackson
    Citation: BMC Medical Research Methodology 2025 25:121
  39. The cluster randomised trial (CRT) design is increasingly used to evaluate the impact of school-based interventions for improving social-emotional functioning outcomes in pupils. Good knowledge is required on ...

    Authors: Kitty Parker, Michael Nunns, ZhiMin Xiao, Tamsin Ford, Paul Stallard, Willem Kuyken, Nick Axford and Obioha C. Ukoumunne
    Citation: BMC Medical Research Methodology 2025 25:120
  40. Choice of survey administration features in surveys mapping population health may influence the participation and the generalizability of the results. This randomized study aimed to investigate whether three d...

    Authors: MS Grønkjær, P Elsborg, CJ Lau, M Bekker-Jeppesen, N Gøtzsche, MH Jacobsen, AH Andreasen and MH Eliasen
    Citation: BMC Medical Research Methodology 2025 25:119
  41. There has been extensive debate about the role of social media and smartphone use in youth mental health and self-harm. Research to date lacks sufficient detail to determine the mechanisms underpinning any ass...

    Authors: Amanda Bye, Emma Wilson-Lemoine, Kylee Trevillion, Ben Carter and Rina Dutta
    Citation: BMC Medical Research Methodology 2025 25:118
  42. Pregnancy and birth cohort studies are essential for studying the social and biological determinants of human health, yet racial and ethnic minority populations are underrepresented due to low recruitment and ...

    Authors: Slawa Rokicki, Amulya Gobburu, Melissa Weidner, Nashwah Azam, Michelle Jansen, Zorimar Rivera-Núñez, Adriana De Resende, Veenat Parmar, Gloria Bachmann, Nancy Reilly, Reynold Panettieri, Maria Gloria Dominguez-Bello, Daniel B. Horton, Martin J. Blaser and Emily S. Barrett
    Citation: BMC Medical Research Methodology 2025 25:117
  43. Large language models (LLMs) like ChatGPT showed great potential in aiding medical research. A heavy workload in filtering records is needed during the research process of evidence-based medicine, especially m...

    Authors: Xiangming Cai, Yuanming Geng, Yiming Du, Bart Westerman, Duolao Wang, Chiyuan Ma and Juan J. Garcia Vallejo
    Citation: BMC Medical Research Methodology 2025 25:116
  44. Self-report methods are widely used to assess energy intake but are prone to measurement errors. We aimed to identify under-reported, over-reported, and plausible self-reported energy intake by dietary recalls...

    Authors: Leinys S. Santos-Báez, Michele N. Ravelli, Diana A. Díaz-Rizzolo, Collin J. Popp, Dympna Gallagher, Bin Cheng, Dale Schoeller and Blandine Laferrère
    Citation: BMC Medical Research Methodology 2025 25:115
  45. Rare events data have proven difficult to explain and predict. Standard statistical procedures can sharply underestimate the probability of rare events, such as intravenous immune globulin therapy (IVIg) for b...

    Authors: Onur Baser, Huseyin Yuce and Gabriela Samayoa
    Citation: BMC Medical Research Methodology 2025 25:114
  46. The aim of equality, equity, diversity, and inclusion (EDI) is to ensure fair treatment, equal opportunities, equitable outcomes, and representation. The NIHR Research Design Service (RDS) EDI toolkit (

    Authors: Ellesha Smith, Carol Akroyd, Rebecca Barnes, Emma Beeston, Jonathan Broomfield, Sylwia Bujkiewicz, Natalie Darko, Christopher Newby, Mark J. Rutherford, Aiden Smith, Rachael Stannard, Freya Tyrer and Laura J. Gray
    Citation: BMC Medical Research Methodology 2025 25:113
  47. Machine learning models have been employed to predict COVID-19 infections and mortality, but many models were built on training and testing sets from different periods. The purpose of this study is to investig...

    Authors: Mingming Chen, Qihang Qian, Xiang Pan and Tenglong Li
    Citation: BMC Medical Research Methodology 2025 25:111
  48. Expert panels are often used as a reference standard when no gold standard is available in diagnostic test accuracy research. It is often unclear what study and expert panel characteristics produce the best es...

    Authors: B. E. Kellerhuis, K. Jenniskens, E. Schuit, L. Hooft, K. G. M. Moons and J. B. Reitsma
    Citation: BMC Medical Research Methodology 2025 25:106

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