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Study design

This section considers manuscripts that investigate how choices of research methodology and study design can impact study results, including research participation and study outcomes.

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  1. Practical methods for facilitating process improvement are needed to support high quality, safe care. How best to specify (identify and define) process improvements – the changes that need to be made in a heal...

    Authors: Jan W. van der Scheer, Matthew Woodward, Akbar Ansari, Tim Draycott, Cathy Winter, Graham Martin, Karolina Kuberska, Natalie Richards, Ruth Kern and Mary Dixon-Woods

    Citation: BMC Medical Research Methodology 2021 21:103

    Content type: Technical advance

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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. 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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  4. 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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  5. 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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  6. 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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  7. 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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  8. 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

    Published on:

  9. 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

    Published on:

  10. 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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  11. 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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  12. 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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  13. 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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  14. 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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  15. 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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  16. 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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  17. 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

    Published on:

  18. Audit and feedback (A&F) interventions are one of the most common approaches for implementing evidence-based practices. A key barrier to more effective A&F interventions is the lack of a theory-guided approach...

    Authors: Heather L. Colquhoun, Kelly Carroll, Kevin W. Eva, Jeremy M. Grimshaw, Noah Ivers, Susan Michie and Jamie C. Brehaut

    Citation: BMC Medical Research Methodology 2021 21:20

    Content type: Research article

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  19. As the development of core outcome sets (COS) increases, guidance for developing and reporting high-quality COS continues to evolve; however, a number of methodological uncertainties still remain. The objectiv...

    Authors: Alexandria Remus, Valerie Smith and Francesca Wuytack

    Citation: BMC Medical Research Methodology 2021 21:10

    Content type: Research article

    Published on:

  20. Although human longevity tends to cluster within families, genetic studies on longevity have had limited success in identifying longevity loci. One of the main causes of this limited success is the selection o...

    Authors: Mar Rodríguez-Girondo, Niels van den Berg, Michel H. Hof, Marian Beekman and Eline Slagboom

    Citation: BMC Medical Research Methodology 2021 21:7

    Content type: Research article

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  21. Bariatric surgery may lead to symptomatic postprandial hypoglycaemia as a major side effect without established therapy so far. We aimed to develop an evidence-based study design of a clinical trial that tests...

    Authors: Matthias Hepprich, Marc Y. Donath and Lars G. Hemkens

    Citation: BMC Medical Research Methodology 2020 20:290

    Content type: Research article

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  22. Assessing benefits and harms of health interventions is resource-intensive and often requires feasibility and pilot trials followed by adequately powered randomised clinical trials. Data from feasibility and p...

    Authors: Ravinder Claire, Christian Gluud, Ivan Berlin, Tim Coleman and Jo Leonardi-Bee

    Citation: BMC Medical Research Methodology 2020 20:284

    Content type: Research article

    Published on:

  23. People who inject drugs (PWID) have been identified as frequent users of emergency department (ED) and hospital inpatient services. The specific challenges of record linkage in cohorts with numerous administra...

    Authors: Rehana Di Rico, Dhanya Nambiar, Belinda Gabbe, Mark Stoové and Paul Dietze

    Citation: BMC Medical Research Methodology 2020 20:283

    Content type: Research article

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  24. One of the Sustainable Development Goals is to reduce the global maternal mortality ratio to less than 70 per 100,000 live births by 2030. In South Africa, the flagship National Department of Health MomConnect...

    Authors: Eveline M Kabongo, Ferdinand C. Mukumbang, Peter Delobelle and Edward Nicol

    Citation: BMC Medical Research Methodology 2020 20:282

    Content type: Research article

    Published on:

  25. We consider the design of stepped wedge trials with continuous recruitment and continuous outcome measures. Suppose we recruit from a fixed number of clusters where eligible participants present continuously, ...

    Authors: Richard Hooper, Jessica Kasza and Andrew Forbes

    Citation: BMC Medical Research Methodology 2020 20:279

    Content type: Research article

    Published on:

  26. To describe how using a combined approach of community-based participatory research and intervention mapping principles could inform the development of a tailored complex intervention to improve management of ...

    Authors: Monica Lakhanpaul, Lorraine Culley, Noelle Robertson, Emma C. Alexander, Deborah Bird, Nicky Hudson, Narynder Johal, Melanie McFeeters, Charlotte Hamlyn-Williams, Logan Manikam, Yebeen Ysabelle Boo, Maya Lakhanpaul and Mark R. D. Johnson

    Citation: BMC Medical Research Methodology 2020 20:271

    Content type: Research article

    Published on:

  27. Although recruitment is a major challenge for most randomized controlled trials, few report on the difficulties of recruitment, or how it might be enhanced. The objective of our study was to qualitatively expl...

    Authors: Jane M. Fletcher, Terry Saunders-Smith, Braden J. Manns, Ross Tsuyuki, Brenda R. Hemmelgarn, Marcello Tonelli and David J. T. Campbell

    Citation: BMC Medical Research Methodology 2020 20:270

    Content type: Research article

    Published on:

  28. Men, particularly those living in disadvantaged areas, are less likely to participate in weight management programmes than women despite similar levels of excess weight. Little is known about how best to recru...

    Authors: Matthew D. McDonald, Stephan U. Dombrowski, Rebecca Skinner, Eileen Calveley, Paula Carroll, Andrew Elders, Cindy M. Gray, Mark Grindle, Fiona M. Harris, Claire Jones and Pat Hoddinott

    Citation: BMC Medical Research Methodology 2020 20:249

    Content type: Research article

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  29. The German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigato...

    Authors: E. Nury, K. Bischoff, K. Wollmann, K. Nitschke, S. Lohner, M. Schumacher, G. Rücker and A. Blümle

    Citation: BMC Medical Research Methodology 2020 20:246

    Content type: Research article

    Published on:

  30. Very large cohorts that span an entire population raise new prospects for the conduct of multiple trials that speed up advances in prevention or treatment while reducing participant, financial and regulatory b...

    Authors: Melissa Wake, Yanhong Jessika Hu, Hayley Warren, Margie Danchin, Michael Fahey, Francesca Orsini, Maurizio Pacilli, Kirsten P. Perrett, Richard Saffery and Andrew Davidson

    Citation: BMC Medical Research Methodology 2020 20:238

    Content type: Technical advance

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  31. Evidence based medicine aims to integrate scientific evidence, clinical experience, and patient values and preferences. Individual health care professionals need to appraise the evidence from randomized trials...

    Authors: Hendrika J. Luijendijk, Matthew J. Page, Huibert Burger and Xander Koolman

    Citation: BMC Medical Research Methodology 2020 20:237

    Content type: Technical advance

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  32. Emergency Departments (EDs) are a first point-of-contact for many youth with mental health and suicidality concerns and can serve as an effective recruitment source for randomized controlled trials (RCTs) of m...

    Authors: Matthew Tracey, Yaron Finkelstein, Reva Schachter, Kristin Cleverley, Suneeta Monga, Melanie Barwick, Peter Szatmari, Myla E. Moretti, Andrew Willan, Joanna Henderson and Daphne J. Korczak

    Citation: BMC Medical Research Methodology 2020 20:231

    Content type: Research article

    Published on:

  33. COVID-19, the disease caused by the highly infectious and transmissible coronavirus SARS-CoV-2, has quickly become a morbid global pandemic. Although the impact of SARS-CoV-2 infection in children is less clin...

    Authors: Rosiane Lima, Elizabeth F. Gootkind, Denis De la Flor, Laura J. Yockey, Evan A. Bordt, Paolo D’Avino, Shen Ning, Katerina Heath, Katherine Harding, Jaclyn Zois, Grace Park, Margot Hardcastle, Kathleen A. Grinke, Sheila Grimmel, Susan P. Davidson, Pamela J. Forde…

    Citation: BMC Medical Research Methodology 2020 20:228

    Content type: Research article

    Published on:

  34. Methodological studies – studies that evaluate the design, analysis or reporting of other research-related reports – play an important role in health research. They help to highlight issues in the conduct of r...

    Authors: Lawrence Mbuagbaw, Daeria O. Lawson, Livia Puljak, David B. Allison and Lehana Thabane

    Citation: BMC Medical Research Methodology 2020 20:226

    Content type: Commentary

    Published on:

  35. Parallel intervention studies involving volunteers usually require a procedure to allocate the subjects to study-arms. Statistical models to evaluate the different outcomes of the study-arms will include study...

    Authors: Eric D. Schoen and Suzan Wopereis

    Citation: BMC Medical Research Methodology 2020 20:222

    Content type: Technical advance

    Published on:

  36. Because of unknown features of the COVID-19 and the complexity of the population affected, standard clinical trial designs on treatments may not be optimal in such patients. We propose two independent clinical...

    Authors: Shesh N. Rai, Chen Qian, Jianmin Pan, Anand Seth, Deo Kumar Srivastava and Aruni Bhatnagar

    Citation: BMC Medical Research Methodology 2020 20:220

    Content type: Research article

    Published on:

  37. Realist methodologies are increasingly being used to evaluate complex interventions in health and social care. Programme theory (ideas and assumptions of how a particular intervention works) development is the...

    Authors: Susanne Coleman, Judy M. Wright, Jane Nixon, Lisette Schoonhoven, Maureen Twiddy and Joanne Greenhalgh

    Citation: BMC Medical Research Methodology 2020 20:217

    Content type: Research article

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  38. This paper reports the construction and use of a specific method for qualitative medical research: The Inductive Process to Analyze the Structure of lived Experience (IPSE), an inductive and phenomenological appr...

    Authors: Jordan Sibeoni, Laurence Verneuil, Emilie Manolios and Anne Révah-Levy

    Citation: BMC Medical Research Methodology 2020 20:216

    Content type: Technical advance

    Published on:

  39. Collection of biospecimens is a critical first step to understanding the impact of COVID-19 on pregnant women and newborns - vulnerable populations that are challenging to enroll and at risk of exclusion from ...

    Authors: Lydia L. Shook, Jessica E. Shui, Adeline A. Boatin, Samantha Devane, Natalie Croul, Lael M. Yonker, Juan D. Matute, Rosiane S. Lima, Muriel Schwinn, Dana Cvrk, Laurel Gardner, Robin Azevedo, Suzanne Stanton, Evan A. Bordt, Laura J. Yockey, Alessio Fasano…

    Citation: BMC Medical Research Methodology 2020 20:215

    Content type: Research article

    Published on:

  40. Evidence is needed regarding effective incentive strategies to increase clinician survey response rates. Cash cards are increasingly used as survey incentives; they are appealing because of their convenience a...

    Authors: Lydia E. Pace, Yeonsoo S. Lee, Nadine Tung, Jada G. Hamilton, Camila Gabriel, Sahitya C. Raja, Colby Jenkins, Anthony Braswell, Susan M. Domchek, Heather Symecko, Kelsey Spielman, Beth Y. Karlan, Jenny Lester, Daniella Kamara, Jeffrey Levin, Kelly Morgan…

    Citation: BMC Medical Research Methodology 2020 20:210

    Content type: Research article

    Published on:

  41. Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical featu...

    Authors: J. Mark FitzGerald, Trung N. Tran, Marianna Alacqua, Alan Altraja, Vibeke Backer, Leif Bjermer, Unnur Bjornsdottir, Arnaud Bourdin, Guy Brusselle, Lakmini Bulathsinhala, John Busby, Giorgio W. Canonica, Victoria Carter, Isha Chaudhry, You Sook Cho, George Christoff…

    Citation: BMC Medical Research Methodology 2020 20:212

    Content type: Research article

    Published on:

  42. Recruitment of adolescents to intervention studies is a known challenge. For randomized controlled trials (RCT) to be generalizable, reach must be assessed, which means ascertaining how many of the intended po...

    Authors: Markus Saarijärvi, Lars Wallin, Philip Moons, Hanna Gyllensten and Ewa-Lena Bratt

    Citation: BMC Medical Research Methodology 2020 20:205

    Content type: Research article

    Published on:

  43. Psychological safety is a dynamic team-level phenomenon which exists when team members believe that it is safe to take interpersonal risks. In healthcare teams, the presence of psychological safety is critical...

    Authors: Róisín O’Donovan, Desirée Van Dun and Eilish McAuliffe

    Citation: BMC Medical Research Methodology 2020 20:203

    Content type: Research article

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  44. Social media has changed the way surgeons communicate worldwide, particularly in dissemination of trial results. However, it is unclear if social media could be used in recruitment to surgical trials. This stu...

    Authors: Carly Nichola Bisset, Ben Carter, Jennifer Law, Jonathan Hewitt, Kat Parmar and Susan Joan Moug

    Citation: BMC Medical Research Methodology 2020 20:201

    Content type: Research article

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  45. Although there is trial evidence that complex interventions are effective for the self-management of heart failure, little evidence supports their effectiveness in routine practice. We used Social Practice The...

    Authors: Julia Frost, Jennifer Wingham, Nicky Britten, Colin Greaves, Charles Abraham, Fiona C. Warren, Hasnain Dalal and Rod S. Taylor

    Citation: BMC Medical Research Methodology 2020 20:181

    Content type: Research article

    Published on:

  46. Linking survey data to administrative records requires informed participant consent. When linkage includes child data, this includes parental and child consent. Little is known of the potential impacts of intr...

    Authors: Kelly Morgan, Nicholas Page, Rachel Brown, Sara Long, Gillian Hewitt, Marcos Del Pozo-Banos, Ann John, Simon Murphy and Graham Moore

    Citation: BMC Medical Research Methodology 2020 20:178

    Content type: Research article

    Published on:

  47. Although the benefits of using methodological frameworks are increasingly recognised, to date, there is no formal definition of what constitutes a ‘methodological framework’, nor is there any published guidanc...

    Authors: Nicola McMeekin, Olivia Wu, Evi Germeni and Andrew Briggs

    Citation: BMC Medical Research Methodology 2020 20:173

    Content type: Research article

    Published on:

  48. A key component of the implementation process is identifying potential barriers and facilitators that need to be addressed. The Theoretical Domains Framework (TDF) is one of the most commonly used frameworks f...

    Authors: Nicole Etherington, Isabel Braganca Rodrigues, Lora Giangregorio, Ian D. Graham, Alison M. Hoens, Danielle Kasperavicius, Christine Kelly, Julia E. Moore, Matteo Ponzano, Justin Presseau, Kathryn M. Sibley and Sharon Straus

    Citation: BMC Medical Research Methodology 2020 20:169

    Content type: Research article

    Published on:

  49. High response rates are essential when questionnaires are used within research, as representativeness can affect the validity of studies and the ability to generalise the findings to a wider population.

    Authors: Michaela Goodwin, Tanya Walsh, William Whittaker, Richard Emsley, Matt Sutton, Martin Tickle, Michael P. Kelly and Iain A. Pretty

    Citation: BMC Medical Research Methodology 2020 20:163

    Content type: Research article

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  50. Awareness of model-based designs for dose-finding studies such as the Continual Reassessment Method (CRM) is now becoming more commonplace amongst clinicians, statisticians and trial management staff. In some ...

    Authors: Erik van Werkhoven, Samantha Hinsley, Eleni Frangou, Jane Holmes, Rosemarie de Haan, Maria Hawkins, Sarah Brown and Sharon B Love

    Citation: BMC Medical Research Methodology 2020 20:162

    Content type: Technical advance

    Published on:

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