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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

    Q methodology is an evidenced approach to researching subjectivity, involving a combination of qualitative and quantitative techniques. The methodology has been used successfully in healthcare research to expl...

    Authors: Melissa Kirschbaum, Tony Barnett and Merylin Cross

    Citation: BMC Medical Research Methodology 2019 19:101

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  2. Content type: Research article

    Bayesian adaptive designs can improve the efficiency of trials, and lead to trials that can produce high quality evidence more quickly, with fewer patients and lower costs than traditional methods. The aim of ...

    Authors: Elizabeth G. Ryan, Julie Bruce, Andrew J. Metcalfe, Nigel Stallard, Sarah E. Lamb, Kert Viele, Duncan Young and Simon Gates

    Citation: BMC Medical Research Methodology 2019 19:99

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  3. Content type: Research article

    Evaluation of complex interventions (CI) is challenging for health researchers and requires innovative approaches. The objective of this work is to present the main methods used to evaluate CI.

    Authors: Laetitia Minary, Justine Trompette, Joëlle Kivits, Linda Cambon, Cyril Tarquinio and François Alla

    Citation: BMC Medical Research Methodology 2019 19:92

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  4. Content type: Research article

    Reliable data from health surveys are essential to describe the status and trends in health indicators by means of information not available from official registers. In Denmark, nationally representative healt...

    Authors: Heidi Amalie Rosendahl Jensen, Ola Ekholm, Michael Davidsen and Anne Illemann Christensen

    Citation: BMC Medical Research Methodology 2019 19:91

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  5. Content type: Research article

    Studies in both paediatric and psychiatric settings often experience problems in recruitment. This can compromise the ability of the study to recruit to target, meaning studies are potentially underpowered. It...

    Authors: Maria E. Loades, Lucie Smith, Nina Higson-Sweeney, Lucy Beasant, Paul Stallard, David Kessler and Esther Crawley

    Citation: BMC Medical Research Methodology 2019 19:89

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  6. Content type: Research article

    Biomarkers of inflammation predictive of cystic fibrosis (CF) disease outcomes would increase the power of clinical trials and contribute to better personalization of clinical assessments. A representative pat...

    Authors: Theodore G. Liou, Frederick R. Adler, Natalia Argel, Fadi Asfour, Perry S. Brown, Barbara A. Chatfield, Cori L. Daines, Dixie Durham, Jessica A. Francis, Barbara Glover, Theresa Heynekamp, John R. Hoidal, Judy L. Jensen, Ruth Keogh, Carol M. Kopecky, Noah Lechtzin…

    Citation: BMC Medical Research Methodology 2019 19:88

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  7. Content type: Research article

    There is evidence that the physician response rate is declining. In response to this, methods for increasing the physician response rate are currently being explored. This paper examines the response rate and ...

    Authors: Lesley Weaver, Timothy J. Beebe and Todd Rockwood

    Citation: BMC Medical Research Methodology 2019 19:73

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  8. Content type: Research article

    Surveys are established methods for collecting population data that are unavailable from other sources; however, response rates to surveys are declining. A number of methods have been identified to increase su...

    Authors: Siân Harrison, Jane Henderson, Fiona Alderdice and Maria A. Quigley

    Citation: BMC Medical Research Methodology 2019 19:65

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  9. Content type: Research article

    Our work was motivated by the need to, given serum availability and/or financial resources, decide on which samples to test in a serum bank for different pathogens. Simulation-based sample size calculations we...

    Authors: Stéphanie Blaizot, Sereina A. Herzog, Steven Abrams, Heidi Theeten, Amber Litzroth and Niel Hens

    Citation: BMC Medical Research Methodology 2019 19:51

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  10. Content type: Research article

    EHR phenotyping offers the ability to rapidly assemble a precisely defined cohort of patients prescreened for eligibility to participate in health-related research. Even so, stakeholders in the process must st...

    Authors: Laura M. Beskow, Kathleen M. Brelsford and Catherine M. Hammack

    Citation: BMC Medical Research Methodology 2019 19:42

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  11. Content type: Research article

    Precarious status migrants are a group of persons who are vulnerable, heterogeneous, and often suspicious of research teams. They are underrepresented in population-based research projects, and strategies to r...

    Authors: Margaux Fête, Josephine Aho, Magalie Benoit, Patrick Cloos and Valéry Ridde

    Citation: BMC Medical Research Methodology 2019 19:41

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  12. Content type: Research article

    Looked after children and care leavers have an increased risk of drug and alcohol use compared to their non-LAC peers. Despite high prevalence rates within this population, looked after children are reported t...

    Authors: Hayley Alderson, Rebecca Brown, Alex Copello, Eileen Kaner, Gillian Tober, Raghu Lingam and Ruth McGovern

    Citation: BMC Medical Research Methodology 2019 19:38

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  13. Content type: Research article

    The aim of the Hellenic National Nutrition and Health Survey was to assess nutritional intake, health status and various behaviors in a representative sample of the Greek population.

    Authors: Emmanuella Magriplis, Ioannis Dimakopoulos, Dimitra Karageorgou, Anastasia-Vasiliki Mitsopoulou, Ioanna Bakogianni, Renata Micha, George Michas, Triantafyllia Ntouroupi, Sophia-Maria Tsaniklidou, Kostantina Argyri, George Danezis, Constantinos Georgiou, Demosthenes B. Panagiotakos and Antonis Zampelas

    Citation: BMC Medical Research Methodology 2019 19:37

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  14. Content type: Research article

    Self-management support programmes are effective in a range of chronic conditions however there is limited evidence for their use in the treatment of chronic headaches. The aim of this study was to test the fe...

    Authors: Kimberley White, Rachel Potter, Shilpa Patel, Vivien P. Nichols, Kirstie L. Haywood, Siew Wan Hee, Dipesh Mistry, Dawn Carnes, Stephanie J. C. Taylor, Martin Underwood and Manjit S. Matharu

    Citation: BMC Medical Research Methodology 2019 19:30

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  15. Content type: Research article

    It is challenging to manage data collection as planned and creation of opportunities to adapt during the course of enrolment may be needed. This paper aims to summarize the different sampling strategies adopte...

    Authors: Ala’a Alkerwi, Jessica Pastore, Nicolas Sauvageot, Gwenaëlle Le Coroller, Valéry Bocquet, Marylène d’Incau, Gloria Aguayo, Brice Appenzeller, Dritan Bejko, Torsten Bohn, Laurent Malisoux, Sophie Couffignal, Stephanie Noppe, Charles Delagardelle, Jean Beissel, Anna Chioti…

    Citation: BMC Medical Research Methodology 2019 19:27

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  16. Content type: Research article

    Recruitment to clinical trials can be challenging. Methods that improve the efficiency of trial recruitment are needed to increase successful study completions. The aim of this study was to ascertain whether s...

    Authors: Amy Rogers, Robert W. V. Flynn, Isla S. Mackenzie and Thomas M. MacDonald

    Citation: BMC Medical Research Methodology 2019 19:24

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  17. Content type: Technical advance

    The continual reassessment method (CRM) is a model-based design for phase I trials, which aims to find the maximum tolerated dose (MTD) of a new therapy. The CRM has been shown to be more accurate in targeting...

    Authors: Graham M. Wheeler, Adrian P. Mander, Alun Bedding, Kristian Brock, Victoria Cornelius, Andrew P. Grieve, Thomas Jaki, Sharon B. Love, Lang’o Odondi, Christopher J. Weir, Christina Yap and Simon J. Bond

    Citation: BMC Medical Research Methodology 2019 19:18

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  18. Content type: Research article

    Data are limited regarding how to effectively and efficiently identify patient priorities for research or clinical care. Our goal was to compare the comprehensiveness and efficiency of group concept mapping (G...

    Authors: Kristin L. Rising, Marianna LaNoue, Alexzandra T. Gentsch, Amanda M. B. Doty, Amy Cunningham, Brendan G. Carr, Judd E. Hollander, Lori Latimer, Larry Loebell, Gail Weingarten, Neva White and Geoffrey Mills

    Citation: BMC Medical Research Methodology 2019 19:7

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  19. Content type: Research article

    Studies elucidating health-related information and special needs of Syrian migrants living in Germany are urgently required. However, data is scarce and finding appropriate sampling strategies to obtain repres...

    Authors: Tobias Weinmann, Amal AlZahmi, Andreas Schneck, Julian Felipe Mancera Charry, Günter Fröschl and Katja Radon

    Citation: BMC Medical Research Methodology 2019 19:5

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  20. Content type: Research article

    In a randomised controlled trial, contamination is defined as the receipt of active intervention amongst participants in the control arm. This review assessed the processes leading to contamination, its typica...

    Authors: Nicholas Magill, Ruth Knight, Paul McCrone, Khalida Ismail and Sabine Landau

    Citation: BMC Medical Research Methodology 2019 19:4

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  21. Content type: Research article

    There are significant challenges to the successful conduct of non-inferiority trials because they require large numbers to demonstrate that an alternative intervention is “not too much worse” than the standard...

    Authors: Iris Lansdorp-Vogelaar, Reshma Jagsi, Jinani Jayasekera, Natasha K. Stout, Sandra A. Mitchell and Eric J. Feuer

    Citation: BMC Medical Research Methodology 2019 19:3

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  22. Content type: Research article

    Although in recent years there has been a strong increase in published research on theories (e.g. realist evaluation, normalization process theory) driving and guiding process evaluations of complex interventi...

    Authors: P. Masterson-Algar, C. R. Burton and J. Rycroft-Malone

    Citation: BMC Medical Research Methodology 2018 18:180

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  23. Content type: Research article

    Workplace health interventions incorporating qualitative and quantitative components (mixed methods) within a Participatory Action Research approach can increase understanding of contextual issues ensuring rea...

    Authors: Marguerite C. Sendall, Laura K. McCosker, Alison Brodie, Melissa Hill and Phil Crane

    Citation: BMC Medical Research Methodology 2018 18:167

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  24. Content type: Research article

    In Sweden, human tissue samples obtained from diagnostic and surgical procedures have for decades been routinely stored in a formalin-fixed, paraffin-embedded, form. Through linkage with nationwide registers, ...

    Authors: Jessica Carlsson, Sabina Davidsson, Jonna Fridfeldt, Francesca Giunchi, Valentina Fiano, Chiara Grasso, Renata Zelic, Lorenzo Richiardi, Ove Andrén, Andreas Pettersson, Michelangelo Fiorentino and Olof Akre

    Citation: BMC Medical Research Methodology 2018 18:161

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  25. Content type: Research article

    Integrated knowledge translation (IKT) is a research approach in which knowledge users (KUs) co-produce research. The rationale for IKT is that it leads to research that is more relevant and useful to KUs, the...

    Authors: Mary Ann O’Brien, Andrea Carson, Lisa Barbera, Melissa C. Brouwers, Craig C. Earle, Ian D. Graham, Nicole Mittmann and Eva Grunfeld

    Citation: BMC Medical Research Methodology 2018 18:150

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  26. 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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  27. 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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  28. 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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  29. 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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  30. 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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  31. 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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  32. 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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  33. 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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  34. 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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  35. 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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  36. 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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  37. 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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  38. 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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  39. 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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  40. 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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  41. 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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  42. 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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  43. 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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  44. 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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