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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. Controlling bias is key to successful randomized controlled trials for behaviour change. Bias can be generated at multiple points during a study, for example, when participants are allocated to different group...

    Authors: Philippe J Giabbanelli and Rik Crutzen

    Citation: BMC Medical Research Methodology 2014 14:130

    Content type: Research article

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  2. Focus groups are commonly used to explore participants’ experiences in health and social care research. Although it is suggested that having demographically homogenous groups may help put participants at ease,...

    Authors: Nan Greenwood, Theresa Ellmers and Jess Holley

    Citation: BMC Medical Research Methodology 2014 14:107

    Content type: Research article

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  3. Paper questionnaires are a common means to collect self-reported information in population-based epidemiological studies. Over the past decades, the response rates to epidemiological studies have been decreasi...

    Authors: Elisa Flüß, Christine M Bond, Gareth T Jones and Gary J Macfarlane

    Citation: BMC Medical Research Methodology 2014 14:104

    Content type: Research article

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  4. In 2012 mobile phone numbers were included into the ongoing New South Wales Population Health Survey (NSWPHS) using an overlapping dual-frame design. Previously in the NSWPHS the sample was selected using rand...

    Authors: Margo L Barr, Raymond A Ferguson, Phil J Hughes and David G Steel

    Citation: BMC Medical Research Methodology 2014 14:102

    Content type: Technical advance

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  5. Randomised controlled trials may be of limited use to evaluate the multidisciplinary and multimodal interventions required to effectively treat complex patients in routine clinical practice; pragmatic action r...

    Authors: Jack J Bell, Tony Rossi, Judith D Bauer and Sandra Capra

    Citation: BMC Medical Research Methodology 2014 14:98

    Content type: Research article

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  6. Insight into local health service provision in rural communities is limited in the literature. The dominant workforce focus in the rural health literature, while revealing issues of shortage of maldistribution...

    Authors: Robyn Adams, Anne Jones, Sophie Lefmann and Lorraine Sheppard

    Citation: BMC Medical Research Methodology 2014 14:94

    Content type: Research article

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  7. Estimates of prevalence are known to be affected by the design of cross-sectional studies. A pan-European study provided an opportunity to compare the effect of two cross-sectional study designs on estimates o...

    Authors: Georgi Nellis, Irja Lutsar, Heili Varendi, Karolin Toompere, Mark A Turner, Jennifer Duncan and Tuuli Metsvaht

    Citation: BMC Medical Research Methodology 2014 14:89

    Content type: Research article

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  8. This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, givi...

    Authors: Ulrike Lorch, Martin O’Kane and Jorg Taubel

    Citation: BMC Medical Research Methodology 2014 14:84

    Content type: Correspondence

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  9. The Patient Reported Outcomes Measurement Information System 43-item short form (PROMIS-43) and the five-level EQ-5D (EQ-5D-5L) are recently developed measures of health-related quality of life (HRQL) that hav...

    Authors: Fang-Ju Lin, A Simon Pickard, Jerry A Krishnan, Min J Joo, David H Au, Shannon S Carson, Suzanne Gillespie, Ashley G Henderson, Peter K Lindenauer, Mary Ann McBurnie, Richard A Mularski, Edward T Naureckas, William M Vollmer and Todd A Lee

    Citation: BMC Medical Research Methodology 2014 14:78

    Content type: Research article

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  10. Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as ...

    Authors: Ian Shrier, John S Raglin, Emily B Levitan, Murray A Mittleman, Russell J Steele and Janette Powell

    Citation: BMC Medical Research Methodology 2014 14:77

    Content type: Research article

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  11. Sequence symmetry analysis (SSA) is a potential tool for rapid detection of adverse drug events (ADRs) associated with newly marketed medicines utilizing computerized claims data. SSA is robust to patient spec...

    Authors: Nicole L Pratt, Jenni Ilomäki, Chris Raymond and Elizabeth E Roughead

    Citation: BMC Medical Research Methodology 2014 14:66

    Content type: Research article

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  12. Randomized controlled trials that test the effectiveness of mobile health-based weight loss programs are attractive to participants, funders, and researchers because of the low implementation cost, minimal par...

    Authors: Kathryn A Paez, Susan J Griffey, Jennifer Thompson and Matthew W Gillman

    Citation: BMC Medical Research Methodology 2014 14:65

    Content type: Research article

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  13. Many investigators are interested in recruiting veterans from recent conflicts in Afghanistan and Iraq with Traumatic Brain Injury (TBI) and/or Post Traumatic Stress Disorder (PTSD). Researchers pursuing such ...

    Authors: Peter J Bayley, Jennifer Y Kong, Drew A Helmer, Aaron Schneiderman, Lauren A Roselli, Stephanie M Rosse, Jordan A Jackson, Janet Baldwin, Linda Isaac, Michael Nolasco, Marc R Blackman, Matthew J Reinhard, John Wesson Ashford and Julie C Chapman

    Citation: BMC Medical Research Methodology 2014 14:48

    Content type: Research article

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  14. In the UK care homes are one of the main providers of long term care for older people with dementia. Despite the recent increase in care home research, residents with dementia are often excluded from studies. ...

    Authors: Sue L Davies, Claire Goodman, Jill Manthorpe, Adam Smith, Natasha Carrick and Steve Iliffe

    Citation: BMC Medical Research Methodology 2014 14:47

    Content type: Research article

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  15. The effectiveness of multiple innovative recruitment strategies for enrolling Black/African American participants to the Adventist Health Study-2 (AHS-2) is described. The study’s focus is diet and breast, pro...

    Authors: Patti Herring, Terry Butler, Sonja Hall, Hannelore Bennett, Susanne B Montgomery and Gary Fraser

    Citation: BMC Medical Research Methodology 2014 14:46

    Content type: Research article

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  16. Recruiting cancer patients is a barrier often encountered in research trials. However, very few randomized trials explore strategies to improve participation rates. The purpose of this study was to evaluate th...

    Authors: Christine Paul, Ryan Courtney, Rob Sanson-Fisher, Mariko Carey, David Hill, Jody Simmons and Shiho Rose

    Citation: BMC Medical Research Methodology 2014 14:44

    Content type: Research article

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  17. Longitudinal prospective birth cohort studies are pivotal to identifying fundamental causes and determinants of disease and health over the life course. There is limited information about the challenges, reten...

    Authors: Megan Lawrance, Susan M Sayers and Gurmeet R Singh

    Citation: BMC Medical Research Methodology 2014 14:31

    Content type: Research article

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  18. Recruitment to trials is complex and often protracted; selection bias may compromise generalisability. In the mental health field (as elsewhere), diverse factors have been described as hindering researcher acc...

    Authors: Rohan Borschmann, Sue Patterson, Dilkushi Poovendran, Danielle Wilson and Tim Weaver

    Citation: BMC Medical Research Methodology 2014 14:23

    Content type: Research article

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  19. When developing new measuring instruments or deciding upon one for research, consideration of the ‘best’ method of administration for the target population should be made. Current evidence is inconsistent in d...

    Authors: Claudia Rutherford, Jane Nixon, Julia M Brown, Donna L Lamping and Stefan J Cano

    Citation: BMC Medical Research Methodology 2014 14:22

    Content type: Research article

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  20. Vignettes are short stories about a hypothetical person, traditionally used within research (quantitative or qualitative) on sensitive topics in the developed world. Studies using vignettes in the developing w...

    Authors: Annabelle Gourlay, Gerry Mshana, Isolde Birdthistle, Grace Bulugu, Basia Zaba and Mark Urassa

    Citation: BMC Medical Research Methodology 2014 14:21

    Content type: Research article

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  21. Self-reported colorectal cancer (CRC) screening behavior is often subject to over-reporting bias. We examined how the inclusion of a future intention to screen item (viz. asking about future intentions to get scr...

    Authors: Timothy J Beebe, Jeanette Y Ziegenfuss, Sarah M Jenkins, Kandace A Lackore and Timothy P Johnson

    Citation: BMC Medical Research Methodology 2014 14:19

    Content type: Research article

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  22. Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Lifestyle intervention can prevent progression to type 2 diabetes in high risk populations. We designed a randomised...

    Authors: Jennifer J Infanti, Angela O’Dea, Irene Gibson, Brian E McGuire, John Newell, Liam G Glynn, Ciaran O’Neill, Susan B Connolly and Fidelma P Dunne

    Citation: BMC Medical Research Methodology 2014 14:13

    Content type: Research article

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  23. Recruiting the required number of participants is vital to the success of clinical research and yet many studies fail to achieve their expected recruitment rate. Increasing research participation is a key agen...

    Authors: Lisa Newington and Alison Metcalfe

    Citation: BMC Medical Research Methodology 2014 14:10

    Content type: Research article

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  24. Tracing mail survey responses is useful for the management of reminders but may cause concerns about anonymity among prospective participants. We examined the impact of numbering return envelopes on the partic...

    Authors: Thomas V Perneger, Stéphane Cullati, Sandrine Rudaz, Thomas Agoritsas, Ralph E Schmidt, Christophe Combescure and Delphine S Courvoisier

    Citation: BMC Medical Research Methodology 2014 14:6

    Content type: Research article

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  25. Authors: Katie Gallacher, Bhautesh Jani, Deborah Morrison, Sara Macdonald, David Blane, Patricia Erwin, Carl R May, Victor M Montori, David T Eton, Fiona Smith, G David Batty and Frances S Mair

    Citation: BMC Medical Research Methodology 2014 13:160

    Content type: Erratum

    Published on:

    The original article was published in BMC Medical Research Methodology 2013 13:10

  26. To assess concordance between Medicare claims and Surveillance, Epidemiology, and End Results (SEER) reports of incident BM among prostate cancer (PCa) patients. The prevalence and consequences of bone metasta...

    Authors: Eberechukwu Onukwugha, Candice Yong, Arif Hussain, Brian Seal and C Daniel Mullins

    Citation: BMC Medical Research Methodology 2014 14:1

    Content type: Research article

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  27. Accrual to Cancer Control and Supportive Care (CCL) studies can be challenging. Our objective was to identify facilitators and perceived barriers to successful Children’s Oncology Group (COG) CCL accrual from ...

    Authors: David VanHoff, Tanya Hesser, Katherine Patterson Kelly, David Freyer, Susan Stork and Lillian Sung

    Citation: BMC Medical Research Methodology 2013 13:154

    Content type: Research article

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  28. The UK leads the world in recruitment of patients to cancer clinical trials, with a six-fold increase in recruitment during 2001–2010. However, there are large variations across cancer centres. This paper deta...

    Authors: Deborah Fenlon, Kim Chivers Seymour, Ikumi Okamoto, Jane Winter, Alison Richardson, Julia Addington-Hall, Jessica L Corner, Peter W Smith, Christine M May, Matthew Breckons and Claire Foster

    Citation: BMC Medical Research Methodology 2013 13:153

    Content type: Research article

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  29. Employing waiting list control designs in psychological and behavioral intervention research may artificially inflate intervention effect estimates. This exploratory randomized controlled trial tested this pro...

    Authors: John A Cunningham, Kypros Kypri and Jim McCambridge

    Citation: BMC Medical Research Methodology 2013 13:150

    Content type: Research article

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  30. Randomised controlled trials are becoming increasingly costly and time-consuming. In 2011, Royston and colleagues proposed a particular class of multi-arm multi-stage (MAMS) designs intended to speed up the ev...

    Authors: Daniel J Bratton, Patrick PJ Phillips and Mahesh KB Parmar

    Citation: BMC Medical Research Methodology 2013 13:139

    Content type: Research article

    Published on:

  31. The way in which maternity care is provided affects perinatal outcomes for pregnant adolescents; including the likelihood of preterm birth. The study purpose was to assess the feasibility of recruiting pregnan...

    Authors: Jyai Allen, Helen Stapleton, Sally Tracy and Sue Kildea

    Citation: BMC Medical Research Methodology 2013 13:138

    Content type: Research article

    Published on:

  32. The Current Opioid Misuse Measure (COMM) is a self-report questionnaire designed to help identify aberrant drug-related behavior in respondents who have been prescribed opioids for chronic pain. The full-lengt...

    Authors: Matthew D Finkelman, Ronald J Kulich, Driss Zoukhri, Niels Smits and Stephen F Butler

    Citation: BMC Medical Research Methodology 2013 13:126

    Content type: Research article

    Published on:

  33. Treatment duration varies with the type of therapy and a patient’s recovery speed. Including such a variation in randomized controlled trials (RCTs) enables comparison of the actual therapeutic potential of di...

    Authors: Hilbert W van der Glas and Robert J van Grootel

    Citation: BMC Medical Research Methodology 2013 13:123

    Content type: Research article

    Published on:

  34. Epidemiologic studies often struggle to adequately represent populations and outcomes of interest. Differences in methodology, data analysis and research questions often mean that reviews and synthesis of the ...

    Authors: Joanne Allen, Kerry J Inder, Terry J Lewin, John R Attia, Frances J Kay-Lambkin, Amanda L Baker, Trevor Hazell and Brian J Kelly

    Citation: BMC Medical Research Methodology 2013 13:122

    Content type: Debate

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  35. Measurement of health-related quality of life (HRQoL) in dementia is difficult. At some point people with dementia become unable to meaningfully assess their own HRQoL. At such a point in time researchers need...

    Authors: Alexander MM Arons, Paul FM Krabbe, Carla JM Schölzel-Dorenbos, Gert Jan van der Wilt and Marcel GM Olde Rikkert

    Citation: BMC Medical Research Methodology 2013 13:110

    Content type: Research article

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  36. There is little published guidance as to the sample size required for a pilot or feasibility trial despite the fact that a sample size justification is a key element in the design of a trial. A sample size jus...

    Authors: Sophie AM Billingham, Amy L Whitehead and Steven A Julious

    Citation: BMC Medical Research Methodology 2013 13:104

    Content type: Research article

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  37. The counterfactual approach provides a clear and coherent framework to think about a variety of important concepts related to causation. Meanwhile, directed acyclic graphs have been used as causal diagrams in ...

    Authors: Etsuji Suzuki, Toshiharu Mitsuhashi, Toshihide Tsuda and Eiji Yamamoto

    Citation: BMC Medical Research Methodology 2013 13:101

    Content type: Research article

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  38. Many researchers favor repeated measures designs because they allow the detection of within-person change over time and typically have higher statistical power than cross-sectional designs. However, the pletho...

    Authors: Yi Guo, Henrietta L Logan, Deborah H Glueck and Keith E Muller

    Citation: BMC Medical Research Methodology 2013 13:100

    Content type: Correspondence

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  39. Cognitive mapping is a participatory research methodology that documents, in visual form, a construct of the local environment in which people live and work. We adapted this method to provide detailed data abo...

    Authors: Jonathan Stadler, Charles Dugmore, Emilie Venables, Catherine MacPhail and Sinead Delany-Moretlwe

    Citation: BMC Medical Research Methodology 2013 13:96

    Content type: Research article

    Published on:

  40. Longitudinal cohort studies are highly valued in epidemiologic research for their ability to establish exposure-disease associations through known temporal sequences. A major challenge in cohort studies is rec...

    Authors: Jaime L Horton, Isabel G Jacobson, Alyson J Littman, John E Alcaraz, Besa Smith and Nancy F Crum-Cianflone

    Citation: BMC Medical Research Methodology 2013 13:90

    Content type: Research article

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  41. As there are limited patients for chronic lymphocytic leukaemia trials, it is important that statistical methodologies in Phase II efficiently select regimens for subsequent evaluation in larger-scale Phase II...

    Authors: Christina Yap, Andrew Pettitt and Lucinda Billingham

    Citation: BMC Medical Research Methodology 2013 13:87

    Content type: Research article

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  42. The use of teams is a well-known approach in a variety of settings, including health care, in both developed and developing countries. Team performance is comprised of teamwork and task work, and ascertaining ...

    Authors: Kojo Yeboah-Antwi, Gail Snetro-Plewman, Karen Z Waltensperger, Davidson H Hamer, Chilobe Kambikambi, William MacLeod, Stephen Filumba, Bias Sichamba and David Marsh

    Citation: BMC Medical Research Methodology 2013 13:84

    Content type: Research article

    Published on:

  43. To compare the results of a new-user cohort study design and the self-controlled case series (SCCS) design using the risk of hospitalisation for pneumonia in those dispensed proton pump inhibitors compared to ...

    Authors: Emmae N Ramsay, Nicole L Pratt, Philip Ryan and Elizabeth E Roughead

    Citation: BMC Medical Research Methodology 2013 13:82

    Content type: Research article

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  44. Drug interactions can have a significant impact on the response to combinatorial therapy for anticancer treatment. In some instances these interactions can be anticipated based on pre-clinical models. However,...

    Authors: Wenfeng Kang, Robert S DiPaola and Alexei Vazquez

    Citation: BMC Medical Research Methodology 2013 13:77

    Content type: Research article

    Published on:

  45. Non-inferiority (NI) trials in drug research are used to demonstrate that a new treatment is not less effective than an active comparator. Since phase IV trials typically aim at informing a clinical decision, ...

    Authors: Rosemarie DLC Bernabe, Grace Wangge, Mirjam J Knol, Olaf H Klungel, Johannes JM van Delden, Anthonius de Boer, Arno W Hoes, Jan AM Raaijmakers and Ghislaine JMW van Thiel

    Citation: BMC Medical Research Methodology 2013 13:70

    Content type: Research article

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  46. The quality of a consultation provided by a physician can have a profound impact on the quality of care and patient engagement in treatment decisions. When the COPD Assessment Test (CAT) was developed, one of ...

    Authors: Kevin Gruffydd-Jones, Helen Marsden, Steve Holmes, Peter Kardos, Roger Escamilla, Roberto Dal Negro, June Roberts, Gilbert Nadeau, David Leather and Paul Jones

    Citation: BMC Medical Research Methodology 2013 13:63

    Content type: Correspondence

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