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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. 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

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  2. 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

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  3. 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

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  4. 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

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  5. 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

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  6. 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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  7. 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

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  8. 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

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  9. 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

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  10. 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

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  11. 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

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  12. 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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  13. 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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  14. 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

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  15. 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

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  16. 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

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  17. 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

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  18. 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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  19. 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

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  20. The inclusion of ‘seldom heard’ groups in health and social care research is increasingly seen as important on scientific, policy and ethical grounds. British South Asians, the largest minority ethnic group in...

    Authors: Suman Prinjha, Nasima Miah, Ebrahim Ali and Andrew Farmer

    Citation: BMC Medical Research Methodology 2020 20:157

    Content type: Research article

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  21. Selection and selection bias are terms that lack consistent definitions and have varying meaning and usage across disciplines. There is also confusion in current definitions between underlying mechanisms that ...

    Authors: Jonas Björk, Anton Nilsson, Carl Bonander and Ulf Strömberg

    Citation: BMC Medical Research Methodology 2020 20:155

    Content type: Research article

    Published on:

  22. At times of increasing pressure on emergency departments, and the need for research into different models of service delivery, little is known about how to recruit patients for qualitative research in emergenc...

    Authors: Delyth Price, Michelle Edwards, Andrew Carson-Stevens, Alison Cooper, Freya Davies, Bridie Evans, Peter Hibbert, Thomas Hughes, Tim Rainer, Niro Siriwardena and Adrian Edwards

    Citation: BMC Medical Research Methodology 2020 20:151

    Content type: Research article

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  26. As technology is advancing, so are the possibilities for new data collection methods in research, potentially improving data quality and validity of the results. In Sweden, a system using frequent repeated dat...

    Authors: I. Axén, I. Jensen, E. Butler Forslund, B. Grahn, V. Jørgensen, C. H. Opava and L. Bodin

    Citation: BMC Medical Research Methodology 2020 20:124

    Content type: Research article

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  27. Patient participation in cancer clinical trials is suboptimal. A challenge to capturing physicians’ insights about trials has been low response to surveys. We conducted a study using varying combinations of ma...

    Authors: Caitlin C. Murphy, Simon J. Craddock Lee, Ann M. Geiger, John V. Cox, Chul Ahn, Rasmi Nair, David E. Gerber, Ethan A. Halm, Katharine McCallister and Celette Sugg Skinner

    Citation: BMC Medical Research Methodology 2020 20:123

    Content type: Research article

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  28. Cancer patients have to undergo a difficult medical therapy and are also confronted with various psychological, social and economic problems. Support is available from many providers, but patients often gain n...

    Authors: Nico Schneider, Anna Bäcker, Katja Brenk-Franz, Christian Keinki, Jutta Hübner, Florian Brandt, Geraldine von der Winkel, Lutz Hager, Bernhard Strauss and Uwe Altmann

    Citation: BMC Medical Research Methodology 2020 20:120

    Content type: Study protocol

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  29. Efforts to improve informed consent have led to calls for providing information a reasonable person would want to have, in a way that facilitates understanding of the reasons why one might or might not want to...

    Authors: Laura M. Beskow, Catherine M. Hammack-Aviran and Kathleen M. Brelsford

    Citation: BMC Medical Research Methodology 2020 20:119

    Content type: Research article

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  30. A nested case-control study is an efficient design that can be embedded within an existing cohort study or randomised trial. It has a number of advantages compared to the conventional case-control design, and ...

    Authors: Christopher Partlett, Nigel J. Hall, Alison Leaf, Edmund Juszczak and Louise Linsell

    Citation: BMC Medical Research Methodology 2020 20:117

    Content type: Research article

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  31. Rapid reviews (RRs) have emerged as an efficient alternative to time-consuming systematic reviews—they can help meet the demand for accelerated evidence synthesis to inform decision-making in healthcare. The s...

    Authors: Ingrid Arevalo-Rodriguez, Karen R. Steingart, Andrea C. Tricco, Barbara Nussbaumer-Streit, David Kaunelis, Pablo Alonso-Coello, Susan Baxter, Patrick M. Bossuyt, José Ignacio Emparanza and Javier Zamora

    Citation: BMC Medical Research Methodology 2020 20:115

    Content type: Research article

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  32. Enrolment in a research study requires the participant’s informed consent. In the case of minors, informed consent of the respective legal guardian is obtained in conjunction with informed assent of the undera...

    Authors: Dominik Soll, Maria Magdalena Guraiib, Nigel Campbell Rollins and Andreas Alois Reis

    Citation: BMC Medical Research Methodology 2020 20:114

    Content type: Research article

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  33. High patient participation in clinical research reduces selection bias and ensures the generalizability of study findings. We explored study-related factors that may influence patients’ willingness to particip...

    Authors: Angèle Gayet-Ageron, Sandrine Rudaz and Thomas Perneger

    Citation: BMC Medical Research Methodology 2020 20:93

    Content type: Research article

    Published on:

  34. The prevalence of oral HPV infection and HPV-related oropharyngeal squamous cell carcinoma (OPSCC) among Indigenous Australians is unknown. This paper outlines the engagement, consultation and recruitment stra...

    Authors: Joanne Hedges, Gail Garvey, Zell Dodd, Warren Miller, Terry Dunbar, Cathy Leane, Amanda Mitchell, Isaac Hill and Lisa Jamieson

    Citation: BMC Medical Research Methodology 2020 20:92

    Content type: Research article

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  35. In randomised controlled trials, the assumption of independence of individual observations is fundamental to the design, analysis and interpretation of studies. However, in individually randomised trials in pr...

    Authors: Beth Stuart, Taeko Becque, Michael Moore and Paul Little

    Citation: BMC Medical Research Methodology 2020 20:83

    Content type: Research article

    Published on:

  36. Modeling studies to inform the design of complex health services interventions often involves elements that differ from the intervention’s ultimate real-world use. These “hypothetical” elements include pilot p...

    Authors: Tavis Hayes, Natasha Hudek, Ian D. Graham, Doug Coyle and Jamie C. Brehaut

    Citation: BMC Medical Research Methodology 2020 20:76

    Content type: Research article

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  37. Exposure to unhealthy environments and inadequate child stimulation are main risk factors that affect children’s health and wellbeing in low- and middle-income countries. Interventions that simultaneously addr...

    Authors: Stella M. Hartinger, Nestor Nuño, Jan Hattendorf, Hector Verastegui, Walter Karlen, Mariela Ortiz and Daniel Mäusezahl

    Citation: BMC Medical Research Methodology 2020 20:73

    Content type: Research article

    Published on:

  38. One of the frequently used methods for assessing research trends and the impact of published scientific literature in a particular discipline is citation analysis. Journals may strive to improve their metrics ...

    Authors: Antonia Jelicic Kadic, Tanja Kovacevic, Edita Runjic, Ana Simicic Majce, Josko Markic, Branka Polic, Julije Mestrovic and Livia Puljak

    Citation: BMC Medical Research Methodology 2020 20:60

    Content type: Research article

    Published on:

  39. Among different investigators studying the same exposures and outcomes, there may be a lack of consensus about potential confounders that should be considered as matching, adjustment, or stratification variabl...

    Authors: Joshua D. Wallach, Stylianos Serghiou, Lingzhi Chu, Alexander C. Egilman, Vasilis Vasiliou, Joseph S. Ross and John P. A. Ioannidis

    Citation: BMC Medical Research Methodology 2020 20:64

    Content type: Research article

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  40. Participant recruitment for clinical research studies remains a significant challenge for researchers. Novel approaches to recruitment are necessary to ensure that populations are easier to reach. In the conte...

    Authors: Janelle Applequist, Cristina Burroughs, Artemio Ramirez Jr, Peter A. Merkel, Marc E. Rothenberg, Bruce Trapnell, Robert J. Desnick, Mustafa Sahin and Jeffrey P. Krischer

    Citation: BMC Medical Research Methodology 2020 20:58

    Content type: Research article

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  41. Trials are at risk of contamination bias which can occur when participants in the control group are inadvertently exposed to the intervention. This is a particular risk in rehabilitation studies where it is ea...

    Authors: K. Robinson, F. Allen, J. Darby, C. Fox, A. L. Gordon, J. C. Horne, P. Leighton, E. Sims and P. A. Logan

    Citation: BMC Medical Research Methodology 2020 20:46

    Content type: Debate

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  42. This article describes the design and baseline sample of a single-site trial comparing Individual Placement and Support (IPS) supported employment delivered within a Veterans Health Administration (VHA) primar...

    Authors: Lori L. Davis, Catherine M. Blansett, Mercy N. Mumba, David MacVicar, Richard Toscano, Patricia Pilkinton, Whitney Gay and Al Bartolucci

    Citation: BMC Medical Research Methodology 2020 20:33

    Content type: Research article

    Published on:

  43. Outcomes in observational studies may not best estimate those expected in the HIV vaccine efficacy trials. We compared retention in Simulated HIV Vaccine Efficacy Trials (SiVETs) and observational cohorts draw...

    Authors: Andrew Abaasa, Jim Todd, Stephen Nash, Yunia Mayanja, Pontiano Kaleebu, Patricia E. Fast and Matt Price

    Citation: BMC Medical Research Methodology 2020 20:32

    Content type: Research article

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  44. Patient and public involvement (PPI) has become enshrined as an important pillar of health services empirical research, including PPI roles during stages of research development and analysis and co-design appr...

    Authors: S. Park, N. Khan, F. Stevenson and A. Malpass

    Citation: BMC Medical Research Methodology 2020 20:29

    Content type: Technical advance

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  45. The quality of medical research importantly depends, among other aspects, on a valid statistical planning of the study, analysis of the data, and reporting of the results, which is usually guaranteed by a bios...

    Authors: Antonia Zapf, Geraldine Rauch and Meinhard Kieser

    Citation: BMC Medical Research Methodology 2020 20:23

    Content type: Debate

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  46. Multicenter studies from Europe and the United States have developed specifically standardized questionnaires for assessing and comparing sedentary behavior, but they cannot be directly applied for South Ameri...

    Authors: Augusto César Ferreira De Moraes, Marcus Vinícius Nascimento-Ferreira, Claudia Lucia de Moraes Forjaz, Juan Carlos Aristizabal, Leticia Azzaretti, Walter Viana Nascimento Junior, Maria L. Miguel-Berges, Estela Skapino, Carlos Delgado, Luis A. Moreno and Heráclito Barbosa Carvalho

    Citation: BMC Medical Research Methodology 2020 20:5

    Content type: Research article

    Published on:

  47. There is a growing interest in the use of Bayesian adaptive designs in late-phase clinical trials. This includes the use of stopping rules based on Bayesian analyses in which the frequentist type I error rate ...

    Authors: Nigel Stallard, Susan Todd, Elizabeth G. Ryan and Simon Gates

    Citation: BMC Medical Research Methodology 2020 20:4

    Content type: Research Article

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  48. Cohort studies are pivotal in understanding the natural history, and to thereby determine the incidence of a disease. The conduct of large-scale community-based cohort studies is challenging with reference to ...

    Authors: Kulandaipalayam Natarajan Sindhu, Manikandan Srinivasan, Sathyapriya Subramaniam, Anita Shirley David, Venkata Raghava Mohan, Jacob John and Gagandeep Kang

    Citation: BMC Medical Research Methodology 2019 19:244

    Content type: Research article

    Published on:

  49. The Multiphase Optimization Strategy (MOST) is designed to maximize the impact of clinical healthcare interventions, which are typically multicomponent and increasingly complex. MOST often relies on factorial ...

    Authors: Jocelyn Kuhn, Radley Christopher Sheldrick, Sarabeth Broder-Fingert, Andrea Chu, Lisa Fortuna, Megan Jordan, Dana Rubin and Emily Feinberg

    Citation: BMC Medical Research Methodology 2019 19:239

    Content type: Technical advance

    Published on:

  50. Trainee research collaboratives (TRCs) have pioneered high quality, prospective ‘snap-shot’ surgical cohort studies in the UK. Outcomes After Kidney injury in Surgery (OAKS) was the first TRC cohort study to a...

    Authors: Dmitri Nepogodiev

    Citation: BMC Medical Research Methodology 2019 19:237

    Content type: Research article

    Published on:

    The Correction to this article has been published in BMC Medical Research Methodology 2020 20:27

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