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Study design

Section edited by Demosthenes Panagiotakos

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. 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:

  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. 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

    Published on:

  8. 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

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  9. 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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  10. 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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  11. 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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  12. 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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  13. 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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  14. 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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  15. 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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  16. 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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  17. 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

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  18. 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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  19. 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

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  20. 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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  21. 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

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  22. 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:

  23. 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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  24. 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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  25. 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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  26. 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

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  27. 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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  28. 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

    Published on:

  29. 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

    Published on:

  30. 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:

  31. 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

    Published on:

  32. 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:

  33. 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:

  34. 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

  35. Falls are common among older people, and General Practitioners (GPs) could play an important role in implementing strategies to manage fall risk. Despite this, fall prevention is not a routine activity in gene...

    Authors: Amy C. W. Tan, Lindy Clemson, Lynette Mackenzie, Catherine Sherrington, Chris Roberts, Anne Tiedemann, Constance D. Pond, Fiona White and Judy M. Simpson

    Citation: BMC Medical Research Methodology 2019 19:236

    Content type: Research article

    Published on:

  36. Consent to link survey data with health-related administrative datasets is increasingly being sought but little is known about the influence of recruiting via online technologies on participants’ consents. The...

    Authors: Anna Graves, Deirdre McLaughlin, Janni Leung and Jennifer Powers

    Citation: BMC Medical Research Methodology 2019 19:235

    Content type: Research article

    Published on:

  37. Our population is ageing and in 2050 more than one out of five people will be 60 years or older; 80% of whom will be living in a low-and-middle income country. Living longer does not entail living healthier; h...

    Authors: Christina Daskalopoulou, Kia-Chong Chua, Artemis Koukounari, Francisco Félix Caballero, Martin Prince and A. Matthew Prina

    Citation: BMC Medical Research Methodology 2019 19:226

    Content type: Research article

    Published on:

    The Research article to this article has been published in BMC Medical Research Methodology 2019 19:225

  38. In the absence of a consensus on definition and measurement of healthy ageing, we created a healthy ageing index tallying with the functional ability framework provided by the World Health Organization. To cre...

    Authors: Christina Daskalopoulou, Martin Prince, Artemis Koukounari, Josep Maria Haro, Demosthenes B. Panagiotakos and A. Matthew Prina

    Citation: BMC Medical Research Methodology 2019 19:225

    Content type: Research article

    Published on:

    The Research article to this article has been published in BMC Medical Research Methodology 2019 19:226

  39. Goal Attainment Scaling (GAS) is an instrument that is intended to evaluate the effect of an intervention by assessing change in daily life activities on an individual basis. However, GAS has not been validate...

    Authors: C. M. W. Gaasterland, M. C. Jansen van der Weide, K. C. B. Roes and J. H. van der Lee

    Citation: BMC Medical Research Methodology 2019 19:227

    Content type: Research article

    Published on:

  40. Central cancer registries are often used to survey population-based samples of cancer survivors. These surveys are typically administered via paper or telephone. In most populations, web surveys obtain much lo...

    Authors: Morgan M. Millar, Joanne W. Elena, Lisa Gallicchio, Sandra L. Edwards, Marjorie E. Carter, Kimberly A. Herget and Carol Sweeney

    Citation: BMC Medical Research Methodology 2019 19:208

    Content type: Research article

    Published on:

  41. Increasing rates of long-term sickness absence are a worldwide problem. Belgium is the first country in Europe that aims to screen its entire population of sick leavers (sick leave > 6 weeks) for the risk of l...

    Authors: Kaat Goorts, Charlotte Vanovenberghe, Charlotte Lambreghts, Eline Bruneel, Dorina Rusu, Marc Du Bois, Sofie Vandenbroeck and Lode Godderis

    Citation: BMC Medical Research Methodology 2019 19:205

    Content type: Research article

    Published on:

    The Correction to this article has been published in BMC Medical Research Methodology 2019 19:224

  42. A standard or consensus definition of a systematic review does not exist. Therefore, if there is no definition about a systematic review in secondary studies that analyse them or the definition is too broad, i...

    Authors: Marina Krnic Martinic, Dawid Pieper, Angelina Glatt and Livia Puljak

    Citation: BMC Medical Research Methodology 2019 19:203

    Content type: Research article

    Published on:

  43. In the early years of life, the benefits of parental engagement in children’s learning are well documented. Early childhood educators are a potentially effective source of support, having opportunity to engage...

    Authors: Zvezdana Petrovic, Olivia Clayton, Jan Matthews, Catherine Wade, Lina Tan, Denny Meyer, Antony Gates, Alex Almendingen and Warren Cann

    Citation: BMC Medical Research Methodology 2019 19:197

    Content type: Study protocol

    Published on:

  44. Health services have not provided adequate support for young people with long term health conditions to transfer from child to adult services. National Institute of Health and Care (NICE) guidance on transitio...

    Authors: Helen Eke, Astrid Janssens, Johnny Downs, Richard M. Lynn, Cornelius Ani and Tamsin Ford

    Citation: BMC Medical Research Methodology 2019 19:179

    Content type: Research article

    Published on:

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