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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.

Page 1 of 4

  1. Content type: Study protocol

    Conducting prospective epidemiological studies of hospitalized patients with rare diseases like primary subarachnoid hemorrhage (pSAH) are difficult due to time and budgetary constraints. Routinely collected a...

    Authors: S. W. English, L. McIntyre, V. Saigle, M. Chassé, D. A. Fergusson, A. F. Turgeon, F. Lauzier, D. Griesdale, A. Garland, R. Zarychanski, A. Algird and C. van Walraven

    Citation: BMC Medical Research Methodology 2018 18:94

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  2. Content type: Technical advance

    Phase III randomized controlled trials (RCT) typically exclude certain patient subgroups, thereby potentially jeopardizing estimation of a drug’s effects when prescribed to wider populations and under routine ...

    Authors: Helene Karcher, Shuai Fu, Jie Meng, Mikkel Zöllner Ankarfeldt, Orestis Efthimiou, Mark Belger, Josep Maria Haro, Lucien Abenhaim and Clementine Nordon

    Citation: BMC Medical Research Methodology 2018 18:75

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  3. Content type: Research article

    Attrition occurs when a participant fails to respond to one or more study waves. The accumulation of attrition over several waves can lower the sample size and power and create a final sample that could differ...

    Authors: Samantha Spiers, Evrim Oral, Elizabeth T. H. Fontham, Edward S. Peters, James L. Mohler, Jeannette T. Bensen and Christine S. Brennan

    Citation: BMC Medical Research Methodology 2018 18:60

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  4. Content type: Research article

    Realist approaches seek to answer questions such as ‘how?’, ‘why?’, ‘for whom?’, ‘in what circumstances?’ and ‘to what extent?’ interventions ‘work’ using context-mechanism-outcome (CMO) configurations. Quanti...

    Authors: John A. Ford, Andy Jones, Geoff Wong, Allan Clark, Tom Porter and Nick Steel

    Citation: BMC Medical Research Methodology 2018 18:57

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  5. Content type: Research article

    Rapid response in health technology assessment is a synthesis of the best available evidence prepared in a timely manner to meet specific demands. We build a consensus among Brazilian specialists in health tec...

    Authors: Marcus Tolentino Silva, Everton Nunes da Silva and Jorge Otávio Maia Barreto

    Citation: BMC Medical Research Methodology 2018 18:51

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  6. Content type: Research article

    The successful initiation of people living with HIV/AIDS on antiretroviral therapy (ART) in South Africa has engendered challenges of poor retention in care and suboptimal adherence to medication. The adherenc...

    Authors: Ferdinand C. Mukumbang, Bruno Marchal, Sara Van Belle and Brian van Wyk

    Citation: BMC Medical Research Methodology 2018 18:47

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  7. Content type: Research article

    List randomization (LR), a survey method intended to mitigate biases related to sensitive true/false questions, has received recent attention from researchers. However, tests of its validity are limited, with ...

    Authors: Noah Haber, Guy Harling, Jessica Cohen, Tinofa Mutevedzi, Frank Tanser, Dickman Gareta, Kobus Herbst, Deenan Pillay, Till Bärnighausen and Günther Fink

    Citation: BMC Medical Research Methodology 2018 18:46

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  8. Content type: Research article

    Systematic reviews and meta-analyses of observational studies are frequently performed, but no widely accepted guidance is available at present. We performed a systematic scoping review of published methodolog...

    Authors: Monika Mueller, Maddalena D’Addario, Matthias Egger, Myriam Cevallos, Olaf Dekkers, Catrina Mugglin and Pippa Scott

    Citation: BMC Medical Research Methodology 2018 18:44

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  9. Content type: Study protocol

    Hybrid research designs targeting adults with neurologic disability are critical for improving the efficiency of models that can identify, track and intervene on identified health issues.

    Authors: James H. Rimmer, Cassandra Herman, Brooks Wingo, Kevin Fontaine and Tapan Mehta

    Citation: BMC Medical Research Methodology 2018 18:28

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  10. Content type: Research article

    Most confirmatory randomised controlled clinical trials (RCTs) are designed with specified power, usually 80% or 90%, for a hypothesis test conducted at a given significance level, usually 2.5% for a one-sided...

    Authors: Michael Pearce, Siew Wan Hee, Jason Madan, Martin Posch, Simon Day, Frank Miller, Sarah Zohar and Nigel Stallard

    Citation: BMC Medical Research Methodology 2018 18:20

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  11. Content type: Research article

    Video vignettes are used to test the effects of physicians’ communication on patient outcomes. Methodological choices in video-vignette development may have far-stretching consequences for participants’ engage...

    Authors: Leonie N. C. Visser, Nadine Bol, Marij A. Hillen, Mathilde G. E. Verdam, Hanneke C. J. M. de Haes, Julia C. M. van Weert and Ellen M. A. Smets

    Citation: BMC Medical Research Methodology 2018 18:15

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  12. Content type: Research article

    While full disclosure of information on placebo control in participant information leaflets (PILs) in a clinical trial is ethically required during informed consent, there have been concerning voices such comp...

    Authors: Soyeon Cheon, Hi-Joon Park, Younbyoung Chae and Hyangsook Lee

    Citation: BMC Medical Research Methodology 2018 18:13

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  13. Content type: Correspondence

    Systematic reviews have been considered as the pillar on which evidence-based healthcare rests. Systematic review methodology has evolved and been modified over the years to accommodate the range of questions ...

    Authors: Zachary Munn, Cindy Stern, Edoardo Aromataris, Craig Lockwood and Zoe Jordan

    Citation: BMC Medical Research Methodology 2018 18:5

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  14. Content type: Research article

    Improving participation rates in epidemiologic studies using questionnaires and biological sampling is important for the generalizability of the outcome. The aim of this study was to examine the effects of pre...

    Authors: Marie Koitsalu, Martin Eklund, Jan Adolfsson, Henrik Grönberg and Yvonne Brandberg

    Citation: BMC Medical Research Methodology 2018 18:3

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  15. Content type: Research article

    Overuse of antibiotics contributes to the global threat of antimicrobial resistance. Antibiotic stewardship interventions address this threat by reducing the use of antibiotics in occasions or doses unlikely t...

    Authors: Patricia J. Lucas, Jenny Ingram, Niamh M. Redmond, Christie Cabral, Sophie L. Turnbull and Alastair D. Hay

    Citation: BMC Medical Research Methodology 2017 17:175

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  16. Content type: Technical advance

    Randomization is considered to be a key feature to protect against bias in randomized clinical trials. Randomization induces comparability with respect to known and unknown covariates, mitigates selection bias...

    Authors: Ralf-Dieter Hilgers, Diane Uschner, William F. Rosenberger and Nicole Heussen

    Citation: BMC Medical Research Methodology 2017 17:159

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  17. Content type: Research article

    There are detailed reviews about different recruitment strategies, but not with regard to differences between recruitment of hospital-based versus office-based physicians. Within this study, the two different ...

    Authors: S. R. Zeissig, V. Weyer-Elberich, K. Emrich, H. Binder, S. Fischbeck, B. H. Imruck, P. Friedrich-Mai, M. E. Beutel and M. Blettner

    Citation: BMC Medical Research Methodology 2017 17:150

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  18. Content type: Research article

    Several statistical approaches have been proposed to assess and correct for exposure measurement error. We aimed to provide a critical overview of the most common approaches used in nutritional epidemiology.

    Authors: Derrick A. Bennett, Denise Landry, Julian Little and Cosetta Minelli

    Citation: BMC Medical Research Methodology 2017 17:146

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  19. Content type: Research article

    The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that ...

    Authors: Kevin P. Weinfurt, Adrian F. Hernandez, Gloria D. Coronado, Lynn L. DeBar, Laura M. Dember, Beverly B. Green, Patrick J. Heagerty, Susan S. Huang, Kathryn T. James, Jeffrey G. Jarvik, Eric B. Larson, Vincent Mor, Richard Platt, Gary E. Rosenthal, Edward J. Septimus, Gregory E. Simon…

    Citation: BMC Medical Research Methodology 2017 17:144

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  20. Content type: Correspondence

    Focused ethnography is an applied and pragmatic form of ethnography that explores a specific social phenomenon as it occurs in everyday life. Based on the literature a problem-focused research question is form...

    Authors: A.P. Bikker, H. Atherton, H. Brant, T. Porqueddu, J.L. Campbell, A. Gibson, B. McKinstry, C. Salisbury and S. Ziebland

    Citation: BMC Medical Research Methodology 2017 17:139

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  21. Content type: Research article

    Knowing about predictors of attrition in a panel is important to initiate early measures against loss of participants. We investigated attrition in both early and late phase of an online panel with special foc...

    Authors: Nicole Rübsamen, Manas K. Akmatov, Stefanie Castell, André Karch and Rafael T. Mikolajczyk

    Citation: BMC Medical Research Methodology 2017 17:132

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  22. Content type: Research article

    The Barthel Index (BI) is a measure of independence in activities of daily living (ADL). In the modified Barthel Index (MBI), a five-point system replaced the original two or three or four point rating system....

    Authors: Tomoko Ohura, Kimitaka Hase, Yoshie Nakajima and Takeo Nakayama

    Citation: BMC Medical Research Methodology 2017 17:131

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  23. Content type: Research article

    This cohort study examined the impact of the lengths of lookback and confirmation periods as well as the definition of confirmatory events on the number of incident cancer cases identified and age-standardized...

    Authors: Jonas Czwikla, Kathrin Jobski and Tania Schink

    Citation: BMC Medical Research Methodology 2017 17:122

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  24. Content type: Research article

    Each year over five million people develop chronic non-malignant pain and can experience healthcare as an adversarial struggle. The aims of this study were: (1) to bring together qualitative evidence syntheses...

    Authors: Fran Toye, Kate Seers, Erin Hannink and Karen Barker

    Citation: BMC Medical Research Methodology 2017 17:116

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  25. Content type: Research Article

    The Matchpoint trial aims to identify the optimal dose of ponatinib to give with conventional chemotherapy consisting of fludarabine, cytarabine and idarubicin to chronic myeloid leukaemia patients in blastic ...

    Authors: Kristian Brock, Lucinda Billingham, Mhairi Copland, Shamyla Siddique, Mirjana Sirovica and Christina Yap

    Citation: BMC Medical Research Methodology 2017 17:112

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  26. Content type: Research article

    African Americans have been historically under-represented in genetic studies. More research is needed on effective recruitment strategies for this population, especially on approaches that supplement traditio...

    Authors: Rebecca Salowe, Laura O’Keefe, Sayaka Merriam, Roy Lee, Naira Khachatryan, Prithvi Sankar, Eydie Miller-Ellis, Amanda Lehman, Victoria Addis, Windell Murphy, Jeffrey Henderer, Maureen Maguire and Joan O’Brien

    Citation: BMC Medical Research Methodology 2017 17:101

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  27. Content type: Research article

    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

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  28. Content type: Research article

    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

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  29. Content type: Research article

    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

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  30. Content type: Research article

    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

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  31. Content type: Research article

    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

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  32. Content type: Study protocol

    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

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  33. Content type: Correspondence

    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

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  34. Content type: Research article

    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

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  35. Content type: Research article

    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

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  36. Content type: Research article

    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

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  37. Content type: Research Article

    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

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  38. Content type: Research article

    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

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  39. 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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  40. 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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  41. 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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  42. 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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  43. 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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  44. 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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  45. 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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  46. 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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