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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. Content type: Research article

    Multiple barriers may inhibit the adoption of clinical interventions and impede successful implementation. Use of standardised methods to prioritise barriers to target when selecting implementation interventio...

    Authors: Louise E. Craig, Leonid Churilov, Liudmyla Olenko, Dominique A. Cadilhac, Rohan Grimley, Simeon Dale, Cintia Martinez-Garduno, Elizabeth McInnes, Julie Considine, Jeremy M. Grimshaw and Sandy Middleton

    Citation: BMC Medical Research Methodology 2017 17:24

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  2. Content type: Research article

    The Government of Cambodia has committed to supporting family care for vulnerable children, including homeless populations. Collecting baseline data on the numbers and characteristics of homeless adolescents w...

    Authors: Lindsay Stark, Beth L. Rubenstein, Kimchoeun Pak, Rosemary Taing, Gary Yu, Sok Kosal and Leslie Roberts

    Citation: BMC Medical Research Methodology 2017 17:13

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  3. Content type: Research article

    Paramedics make important and increasingly complex decisions at scene about patient care. Patient safety implications of influences on decision making in the pre-hospital setting were previously under-research...

    Authors: Maxine Johnson, Rachel O’Hara, Enid Hirst, Andrew Weyman, Janette Turner, Suzanne Mason, Tom Quinn, Jane Shewan and A. Niroshan Siriwardena

    Citation: BMC Medical Research Methodology 2017 17:11

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  4. Content type: Research article

    Connected individuals (or nodes) in a network are more likely to be similar than two randomly selected nodes due to homophily and/or network influence. Distinguishing between these two influences is an importa...

    Authors: Kori Sauser Zachrison, Theodore J. Iwashyna, Achamyeleh Gebremariam, Meghan Hutchins and Joyce M Lee

    Citation: BMC Medical Research Methodology 2016 16:174

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  5. Content type: Research article

    This paper describes the methodological developments of the sexual health items included in the Health Behaviour in School-aged Children (HBSC) study since their mandatory inclusion in the study in 2002. The c...

    Authors: Honor Young, András Költő, Marta Reis, Elizabeth M. Saewyc, Nathalie Moreau, Lorraine Burke, Alina Cosma, Béat Windlin, Saoirse Nic Gabhainn and Emmanuelle Godeau

    Citation: BMC Medical Research Methodology 2016 16:169

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  6. Content type: Research article

    Conventional randomized placebo-controlled study design assumes the absence of drug*placebo interaction. We hypothesized the presence of such an interaction and that conventionally estimated drug effect might ...

    Authors: Muhammad M. Hammami, Safa Hammami, Reem Al-Swayeh, Eman Al-Gaai, Faduma Abdi Farah and Sophia J. S. De Padua

    Citation: BMC Medical Research Methodology 2016 16:166

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  7. Content type: Research article

    As biobanks play an increasing role in the genomic research that will lead to precision medicine, input from diverse and large populations of patients in a variety of health care settings will be important in ...

    Authors: Maureen E. Smith, Saskia C. Sanderson, Kyle B. Brothers, Melanie F. Myers, Jennifer McCormick, Sharon Aufox, Martha J. Shrubsole, Nanibaá A. Garrison, Nathaniel D. Mercaldo, Jonathan S. Schildcrout, Ellen Wright Clayton, Armand H. Matheny Antommaria, Melissa Basford, Murray Brilliant, John J. Connolly, Stephanie M. Fullerton…

    Citation: BMC Medical Research Methodology 2016 16:162

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  8. Content type: Research article

    Variation in development methods of Pressure Ulcer Risk Assessment Instruments has led to inconsistent inclusion of risk factors and concerns about content validity. A new evidenced-based Risk Assessment Instr...

    Authors: S. Coleman, J. Nixon, J. Keen, D. Muir, L. Wilson, E. McGinnis, N. Stubbs, C. Dealey and E. A. Nelson

    Citation: BMC Medical Research Methodology 2016 16:158

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  9. Content type: Research article

    Effective community-partnered and patient-centered outcomes research needs to address community priorities. However, optimal sampling methods to engage stakeholders from hard-to-reach, vulnerable communities t...

    Authors: Melissa A. Valerio, Natalia Rodriguez, Paula Winkler, Jaime Lopez, Meagen Dennison, Yuanyuan Liang and Barbara J. Turner

    Citation: BMC Medical Research Methodology 2016 16:146

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  10. Content type: Study protocol

    Hydroxyurea (HU) has been demonstrated to be efficacious in reducing complications in individuals with sickle cell anemia (SCA) but poor adherence is a barrier. Directly Observed Therapy (DOT) has been shown t...

    Authors: Abel Makubi, Philip Sasi, Mariam Ngaeje, Enrico M. Novelli, Bruno P. Mmbando, Mark T. Gladwin and Julie Makani

    Citation: BMC Medical Research Methodology 2016 16:140

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  11. Content type: Research article

    Sepsis and severe sepsis are common conditions in hospital settings, and are associated with high rates of morbidity and mortality, but reported incidences vary considerably. In this literature review, we desc...

    Authors: Saga Elise Mariansdatter, Andreas Halgreen Eiset, Kirstine Kobberøe Søgaard and Christian Fynbo Christiansen

    Citation: BMC Medical Research Methodology 2016 16:137

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  12. Content type: Research article

    Selective allocation of patients into the compared groups of a randomised trial may cause allocation bias, but the mechanisms behind the bias and its directionality are incompletely understood. We therefore an...

    Authors: Asger Paludan-Müller, David Ruben Teindl Laursen and Asbjørn Hróbjartsson

    Citation: BMC Medical Research Methodology 2016 16:133

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  13. Content type: Research article

    The self-controlled case series (SCCS) is a useful design for investigating associations between outcomes and transient exposures. The SCCS design controls for all fixed covariates, but effect modification can...

    Authors: Steven Hawken, Beth K. Potter, Julian Little, Eric I. Benchimol, Salah Mahmud, Robin Ducharme and Kumanan Wilson

    Citation: BMC Medical Research Methodology 2016 16:126

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  14. Content type: Research article

    There are a variety of methods for priority setting in health research but few studies have addressed how to prioritise the gaps that exist between research evidence and clinical practice. This study aimed to ...

    Authors: Nicole M. Rankin, Deborah McGregor, Phyllis N. Butow, Kate White, Jane L. Phillips, Jane M. Young, Sallie A. Pearson, Sarah York and Tim Shaw

    Citation: BMC Medical Research Methodology 2016 16:110

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  15. Content type: Debate

    Evidence syntheses, and in particular systematic reviews (SRs), have become one of the cornerstones of evidence-based health care. The Assessment of Multiple Systematic Reviews (AMSTAR) tool has become the mos...

    Authors: Uta Wegewitz, Beate Weikert, Alba Fishta, Anja Jacobs and Dawid Pieper

    Citation: BMC Medical Research Methodology 2016 16:111

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  16. Content type: Research article

    The Cohort Multiple Randomised Controlled Trial (cmRCT) is a newly proposed pragmatic trial design; recently several cmRCT have been initiated. This study tests the unresolved question of whether differential ...

    Authors: Alexander Pate, Jane Candlish, Matthew Sperrin and Tjeerd Pieter Van Staa

    Citation: BMC Medical Research Methodology 2016 16:109

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  17. Content type: Research article

    Our aim is to conduct an exploratory study to provide an in-depth characterization of a neighborhood’s social and physical environment in relation to cardiovascular health. A mixed-methods approach was used to...

    Authors: Usama Bilal, Julia Díez, Silvia Alfayate, Pedro Gullón, Isabel del Cura, Francisco Escobar, María Sandín and Manuel Franco

    Citation: BMC Medical Research Methodology 2016 16:104

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  18. Content type: Research article

    In observational studies, matched case-control designs are routinely conducted to improve study precision. How to select covariates for match or adjustment, however, is still a great challenge for estimating c...

    Authors: Hongkai Li, Zhongshang Yuan, Ping Su, Tingting Wang, Yuanyuan Yu, Xiaoru Sun and Fuzhong Xue

    Citation: BMC Medical Research Methodology 2016 16:102

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  19. Content type: Correspondence

    Community-based research has gained increasing recognition in health research over the last two decades. Such participatory research approaches are lauded for their ability to anchor research in lived experien...

    Authors: Mona Loutfy, Saara Greene, V. Logan Kennedy, Johanna Lewis, Jamie Thomas-Pavanel, Tracey Conway, Alexandra de Pokomandy, Nadia O’Brien, Allison Carter, Wangari Tharao, Valerie Nicholson, Kerrigan Beaver, Danièle Dubuc, Jacqueline Gahagan, Karène Proulx-Boucher, Robert S. Hogg…

    Citation: BMC Medical Research Methodology 2016 16:101

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  20. Content type: Research article

    There is currently no guidance for selecting a specific difference to be detected in a superiority trial. We explored 3 factors that in our opinion should influence the difference to be detected (type of outco...

    Authors: Angèle Gayet-Ageron, Anne-Sophie Jannot, Thomas Agoritsas, Sandrine Rudaz, Christophe Combescure and Thomas Perneger

    Citation: BMC Medical Research Methodology 2016 16:89

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  21. Content type: Study protocol

    Placebo effects are mediated by expectancy, which is highly influenced by psychosocial factors of a treatment context. These factors are difficult to standardize. Furthermore, dedicated placebo research often ...

    Authors: Bjoern Horing, Nathan D. Newsome, Paul Enck, Sabarish V. Babu and Eric R. Muth

    Citation: BMC Medical Research Methodology 2016 16:84

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  22. Content type: Research article

    A systematic review on the use of incentives to promote questionnaire return in clinical trials suggest they are effective, but not all studies have sufficient funds to use them. Promising an incentive once da...

    Authors: Pollyanna Hardy, Jennifer L. Bell and Peter Brocklehurst

    Citation: BMC Medical Research Methodology 2016 16:82

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  23. Content type: Research article

    Action research (AR) and randomized controlled trials (RCTs) are usually considered to be theoretically and practically incompatible. However, we argue that their respective strengths and weaknesses can be com...

    Authors: Karen Day, Timothy W. Kenealy and Nicolette F. Sheridan

    Citation: BMC Medical Research Methodology 2016 16:70

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  24. Content type: Research article

    Given the worldwide proliferation of cellphones, this paper examines their potential use for the surveillance of non-communicable disease (NCD) risk factors in a Middle Eastern country.

    Authors: Abla M. Sibai, Lilian A. Ghandour, Rawan Chaaban and Ali H. Mokdad

    Citation: BMC Medical Research Methodology 2016 16:64

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  25. Content type: Research article

    The Drug-Taking Confidence Questionnaire evaluates a drug user’s confidence in his or her ability to resist the urge to consume psychoactive substances in high-risk situations. This study’s objective was to de...

    Authors: Selene Cordeiro Vasconcelos, Everton Botelho Sougey, Iracema da Silva Frazão, Nigel Ernest Turner, Vânia Pinheiro Ramos and Murilo Duarte da Costa Lima

    Citation: BMC Medical Research Methodology 2016 16:55

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  26. Content type: Research article

    This study aimed to characterise the factors relating to participation in a postal follow-up study in Aboriginal and non-Aboriginal individuals, given the need to quantify potential biases from loss to follow-...

    Authors: Lina Gubhaju, Emily Banks, Rona Macniven, Grace Joshy, Bridgette J. McNamara, Adrian Bauman and Sandra J. Eades

    Citation: BMC Medical Research Methodology 2016 16:53

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  27. Content type: Technical advance

    An increasing number of qualitative evidence syntheses papers are found in health care literature. Many of these syntheses use a strictly exhaustive search strategy to collect articles, mirroring the standard ...

    Authors: Charlotte Benoot, Karin Hannes and Johan Bilsen

    Citation: BMC Medical Research Methodology 2016 16:21

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  28. Content type: Research article

    It is well recognized that treatment effects may not be homogeneous across the study population. Subgroup analyses constitute a fundamental step in the assessment of evidence from confirmatory (Phase III) clin...

    Authors: Julien Tanniou, Ingeborg van der Tweel, Steven Teerenstra and Kit C. B. Roes

    Citation: BMC Medical Research Methodology 2016 16:20

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  29. Content type: Research article

    Inefficient experimental designs are common in animal-based biomedical research, wasting resources and potentially leading to unreplicable results. Here we illustrate the intrinsic statistical power of split-p...

    Authors: Michael Walker, Carole Fureix, Rupert Palme, Jonathan A. Newman, Jamie Ahloy Dallaire and Georgia Mason

    Citation: BMC Medical Research Methodology 2016 16:11

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  30. Content type: Research article

    With the increase of clinical trial costs during the last decades, the design of feasibility studies has become an essential process to reduce avoidable and costly protocol amendments. This design includes tim...

    Authors: Iñaki Soto-Rey, Benjamin Trinczek, Yannick Girardeau, Eric Zapletal, Nadir Ammour, Justin Doods, Martin Dugas and Fleur Fritz

    Citation: BMC Medical Research Methodology 2015 15:44

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  31. Content type: Research article

    Informed consent is the foundation of the ethical conduct of health research. Obtaining informed consent may unwittingly interfere with the data collected in research studies, particularly if they concern sens...

    Authors: Lambert Felix, Patrick Keating and Jim McCambridge

    Citation: BMC Medical Research Methodology 2015 15:41

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  32. Content type: Research article

    Survey research in healthcare is an important tool to collect information about healthcare delivery, service use and overall issues relating to quality of care. Unfortunately, physicians are often a group with...

    Authors: Ceara Tess Cunningham, Hude Quan, Brenda Hemmelgarn, Tom Noseworthy, Cynthia A Beck, Elijah Dixon, Susan Samuel, William A Ghali, Lindsay L Sykes and Nathalie Jetté

    Citation: BMC Medical Research Methodology 2015 15:32

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  33. Content type: Research article

    Low participation rates reduce effective sample size, statistical power and can increase risk for selection bias. Previous research suggests that offering choice of participation mode can improve participation...

    Authors: Naomi Heijmans, Jan van Lieshout and Michel Wensing

    Citation: BMC Medical Research Methodology 2015 15:29

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  34. Content type: Research article

    Effective strategies for contacting and recruiting study participants are critical in conducting clinical research. In this study, we conducted two sequential randomized controlled trials of mail- and telephon...

    Authors: Victor D Dinglas, Minxuan Huang, Kristin A Sepulveda, Mariela Pinedo, Ramona O Hopkins, Elizabeth Colantuoni and Dale M Needham

    Citation: BMC Medical Research Methodology 2015 15:5

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  35. Content type: Research article

    General Practitioners (GPs) respond poorly to postal surveys. Consequently there is potential for reduced data quality and bias in the findings. In general population surveys, response to postal questionnaires...

    Authors: Elizabeth Cottrell, Edward Roddy, Trishna Rathod, Elaine Thomas, Mark Porcheret and Nadine E Foster

    Citation: BMC Medical Research Methodology 2015 15:3

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  36. Content type: Research article

    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

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  37. Content type: Research article

    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

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  38. Content type: Research article

    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

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  39. Content type: Technical advance

    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

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  40. Content type: Research article

    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

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  41. Content type: Research article

    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

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  42. Content type: Research article

    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

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  43. Content type: Correspondence

    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

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  44. Content type: Research article

    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

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  45. Content type: Research article

    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

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