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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. Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to b...

    Authors: Rochelle Yang, Barry L. Carter, Tyler H. Gums, Brian M. Gryzlak, Yinghui Xu and Barcey T. Levy

    Citation: BMC Medical Research Methodology 2017 17:94

    Content type: Research article

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  2. Many medicines are dosed to achieve a particular therapeutic range, and monitored using therapeutic drug monitoring (TDM). The evidence base for a therapeutic range can be evaluated using systematic reviews, t...

    Authors: Lewis Cooney, Yoon K. Loke, Su Golder, Jamie Kirkham, Andrea Jorgensen, Ian Sinha and Daniel Hawcutt

    Citation: BMC Medical Research Methodology 2017 17:84

    Content type: Research article

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  3. We describe a novel strategy for power and sample size determination developed for studies utilizing investigational technologies with limited available preliminary data, specifically of imaging biomarkers. We...

    Authors: Christine E. McLaren, Wen-Pin Chen, Thomas D. O’Sullivan, Daniel L. Gillen, Min-Ying Su, Jeon H. Chen and Bruce J. Tromberg

    Citation: BMC Medical Research Methodology 2017 17:75

    Content type: Research article

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  4. Previous research has found that a “web-push” approach to data collection, which involves contacting people by mail to request an Internet survey response while withholding a paper response option until later ...

    Authors: Hope Seib McMaster, Cynthia A. LeardMann, Steven Speigle and Don A. Dillman

    Citation: BMC Medical Research Methodology 2017 17:73

    Content type: Research article

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  5. Evaluation of the potential effectiveness of a programme’s objectives (health or otherwise) is important in demonstrating how programmes work. However, evaluations are expensive and can focus on unrealistic ou...

    Authors: Melissa Belford, Tony Robertson and Ruth Jepson

    Citation: BMC Medical Research Methodology 2017 17:70

    Content type: Research article

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  6. Maternity intrapartum care research and clinical care more often focus on outcomes that minimise or prevent adverse health rather than on what constitutes positive health and wellbeing (salutogenesis). This wa...

    Authors: Valerie Smith, Deirdre Daly, Ingela Lundgren, Tine Eri, Cecily Begley, Mechthild M. Gross, Soo Downe, Zarko Alfirevic and Declan Devane

    Citation: BMC Medical Research Methodology 2017 17:61

    Content type: Study protocol

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  7. Obesity and obesity-related conditions, such as type 2 diabetes, are a major issue for Veteran health. Veterans Health Administration (VA) researchers and health systems leaders have worked separately and toge...

    Authors: Mona AuYoung, Laura J. Damschroder, Linda Kinsinger, Tannaz Moin and Caroline R. Richardson

    Citation: BMC Medical Research Methodology 2017 17:50

    Content type: Correspondence

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  8. The effects of postal questionnaire burden on return rates and answers given are unclear following treatment on an intensive care unit (ICU). We aimed to establish the effects of different postal questionnaire...

    Authors: Robert Hatch, Duncan Young, Vicki Barber, David A Harrison and Peter Watkinson

    Citation: BMC Medical Research Methodology 2017 17:49

    Content type: Research article

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  9. Propensity scores are typically applied in retrospective cohort studies. We describe the feasibility of matching on a propensity score derived from a retrospective cohort and subsequently applied in a prospect...

    Authors: Eric S. Johnson, John F. Dickerson, William M. Vollmer, Alee M. Rowley, Cheryl Ritenbaugh, Richard A. Deyo and Lynn DeBar

    Citation: BMC Medical Research Methodology 2017 17:42

    Content type: Research article

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  10. Sample selection can substantially affect the solutions generated using exploratory factor analysis. Validation studies of the 12-item World Health Organization (WHO) Disability Assessment Schedule 2.0 (WHODAS...

    Authors: Cadeyrn J. Gaskin, Sylvie D. Lambert, Steven J. Bowe and Liliana Orellana

    Citation: BMC Medical Research Methodology 2017 17:40

    Content type: Research article

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  11. Information and theory beyond copula concepts are essential to understand the dependence relationship between several marginal covariates distributions. In a therapeutic trial data scheme, most of the time, ce...

    Authors: Charles Fontaine, Jean-Pierre Daurès and Paul Landais

    Citation: BMC Medical Research Methodology 2017 17:27

    Content type: Research Article

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  12. Observational studies are widely used in pharmacoepidemiology. Several designs can be used, in particular self-controlled designs (case-crossover and self-controlled case series). These designs offer the advan...

    Authors: Nathalie Gault, Johann Castañeda-Sanabria, Yann De Rycke, Sylvie Guillo, Stéphanie Foulon and Florence Tubach

    Citation: BMC Medical Research Methodology 2017 17:25

    Content type: Research article

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  13. 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

    Content type: Research article

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  14. 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

    Content type: Research article

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  15. 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

    Content type: Research article

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  16. 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

    Content type: Research article

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  17. 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

    Content type: Research article

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  18. 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

    Content type: Research article

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  19. 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

    Content type: Research article

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  20. 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

    Content type: Research article

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  21. 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

    Content type: Research article

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  22. 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

    Content type: Study protocol

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  23. 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

    Content type: Research article

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  24. 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

    Content type: Research article

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  25. 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

    Content type: Research article

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  26. 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

    Content type: Debate

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  27. 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

    Content type: Research article

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  28. 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

    Content type: Research article

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  29. 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

    Content type: Research article

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  30. 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

    Content type: Research article

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  31. 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

    Content type: Correspondence

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  32. 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

    Content type: Research article

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  33. 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

    Content type: Study protocol

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  34. 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

    Content type: Research article

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  35. 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

    Content type: Research article

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  36. 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

    Content type: Research article

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  37. 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

    Content type: Research article

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  38. 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

    Content type: Research article

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  39. 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

    Content type: Technical advance

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  40. 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

    Content type: Research article

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  41. 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

    Content type: Research article

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  42. 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

    Content type: Research article

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  43. 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

    Content type: Research article

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  44. 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

    Content type: Research article

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  45. 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

    Content type: Research article

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  46. 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

    Content type: Research article

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  47. 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

    Content type: Research article

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