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Qualitative Methods, Trials and Systematic Reviews

Edited by: Prof David Gough (Systematic Reviews) and Dr Claire Snowdon (Trials)

The two sister-journals, Trials and Systematic Reviews, have, on the face of it, different readerships and deal with different issues. In both journals there is, however, a common and growing interest in the contribution of qualitative methods. We are seeing an expansion of the use and application of a range of techniques with entry into novel research areas and pursuit of new lines of inquiry. Our contributors are working within specific methods, with mixed methods, and across paradigms.

This special issue covers these innovative and challenging areas, with the aim of sharing methodological practice, findings and reflections to drive forward and further the respective fields.

  1. Research

    Convergent and sequential synthesis designs: implications for conducting and reporting systematic reviews of qualitative and quantitative evidence

    Systematic reviews of qualitative and quantitative evidence can provide a rich understanding of complex phenomena. This type of review is increasingly popular, has been used to provide a landscape of existing ...

    Quan Nha Hong, Pierre Pluye, Mathieu Bujold and Maggy Wassef

    Systematic Reviews 2017 6:61

    Published on: 23 March 2017

  2. Research

    Meta-analysis, complexity, and heterogeneity: a qualitative interview study of researchers’ methodological values and practices

    Complex or heterogeneous data pose challenges for systematic review and meta-analysis. In recent years, a number of new methods have been developed to meet these challenges. This qualitative interview study ai...

    Theo Lorenc, Lambert Felix, Mark Petticrew, G J Melendez-Torres, James Thomas, Sian Thomas, Alison O’Mara-Eves and Michelle Richardson

    Systematic Reviews 2016 5:192

    Published on: 16 November 2016

  3. Research

    What guidance is available for researchers conducting overviews of reviews of healthcare interventions? A scoping review and qualitative metasummary

    Overviews of reviews (overviews) compile data from multiple systematic reviews to provide a single synthesis of relevant evidence for decision-making. Despite their increasing popularity, there is limited meth...

    Michelle Pollock, Ricardo M. Fernandes, Lorne A. Becker, Robin Featherstone and Lisa Hartling

    Systematic Reviews 2016 5:190

    Published on: 14 November 2016

  4. Study protocol

    Postprandial effect of breakfast glycaemic index on vascular function, glycaemic control and cognitive performance (BGI study): study protocol for a randomised crossover trial

    Postprandial glycaemic response affects cognitive and vascular function. The acute effect of breakfast glycaemic index on vascular parameters is not sufficiently known. Also, the influence of breakfasts with d...

    Natalia Sanchez-Aguadero, Luis Garcia-Ortiz, Maria C. Patino-Alonso, Sara Mora-Simon, Manuel A. Gomez-Marcos, Rosario Alonso-Dominguez, Benigna Sanchez-Salgado and Jose I. Recio-Rodriguez

    Trials 2016 17:516

    Published on: 24 October 2016

  5. Research

    Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery

    The development and use of core outcome sets (COSs) in trials may improve data synthesis and reduce outcome reporting bias. The selection of outcomes in COSs is informed by views of key stakeholders, yet littl...

    Shelley Potter, Sara T. Brookes, Christopher Holcombe, Joseph A. Ward and Jane M. Blazeby

    Trials 2016 17:463

    Published on: 23 September 2016

  6. Research

    How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction)

    Randomised controlled trials (RCTs) often fail to recruit sufficient participants, despite altruism being cited as their motivation. Previous investigations of factors influencing participation decisions have ...

    Natalie Bidad, Lindsay MacDonald, Zoë E. Winters, Sarah J. L. Edwards, Marie Emson, Clare L. Griffin, Judith Bliss and Rob Horne

    Trials 2016 17:431

    Published on: 2 September 2016

  7. Research

    Stakeholders’ views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs

    We explored the views of key stakeholders to identify the ethical challenges of pragmatic trials investigating pharmaceutical drugs. A secondary aim was to capture stakeholders’ attitudes towards the implement...

    Shona Kalkman, Ghislaine J. M. W. van Thiel, Diederick E. Grobbee, Anna-Katharina Meinecke, Mira G. P. Zuidgeest and Johannes J. M. van Delden

    Trials 2016 17:419

    Published on: 22 August 2016

  8. Methodology

    The role of qualitative research in adding value to a randomised controlled trial: lessons from a pilot study of a guided e-learning intervention for managers to improve employee wellbeing and reduce sickness absence

    Despite the growing popularity of mixed-methods studies and considerable emphasis on the potential value of qualitative research to the trial endeavour, there remains a dearth of published studies reporting on...

    Jill Russell, Lee Berney, Stephen Stansfeld, Doris Lanz, Sally Kerry, Tarani Chandola and Kamaldeep Bhui

    Trials 2016 17:396

    Published on: 9 August 2016

  9. Research

    “I didn’t really understand it, I just thought it’d help”: exploring the motivations, understandings and experiences of patients with advanced lung cancer participating in a non-placebo clinical IMP trial

    Few studies have explored in depth the experiences of patients with advanced cancer who are participating in clinical investigational medicinal product trials. However, integrated qualitative studies in such t...

    Emily Harrop, Simon Noble, Michelle Edwards, Stephanie Sivell, Barbara Moore and Annmarie Nelson

    Trials 2016 17:329

    Published on: 20 July 2016

  10. Research

    What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges

    Clinical trials oversight by a Trial Steering Committee (TSC) is mandated by Good Clinical Practice. This study used qualitative methods to explore the role and valued attributes of the TSC to inform planned u...

    Anne Daykin, Lucy E. Selman, Helen Cramer, Sharon McCann, Gillian W. Shorter, Matthew R. Sydes, Carrol Gamble, Rhiannon Macefield, J. Athene Lane and Alison Shaw

    Trials 2016 17:307

    Published on: 1 July 2016

  11. Research

    The role of therapeutic optimism in recruitment to a clinical trial in a peripartum setting: balancing hope and uncertainty

    Hope has therapeutic value because it enables people to cope with uncertainty about their future health. Indeed, hope, or therapeutic optimism (TO), is seen as an essential aspect of the provision and experien...

    Nina Hallowell, Claire Snowdon, Susan Morrow, Jane E. Norman, Fiona C. Denison and Julia Lawton

    Trials 2016 17:267

    Published on: 1 June 2016

  12. Research

    Identifying configurations of behavior change techniques in effective medication adherence interventions: a qualitative comparative analysis

    Interventions to improve medication adherence are diverse and complex. Consequently, synthesizing this evidence is challenging. We aimed to extend the results from an existing systematic review of intervention...

    Leila Kahwati, Meera Viswanathan, Carol E. Golin, Heather Kane, Megan Lewis and Sara Jacobs

    Systematic Reviews 2016 5:83

    Published on: 4 May 2016

  13. Research

    ‘The trial is owned by the team, not by an individual’: a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology

    Challenges exist in recruitment to trials involving interventions delivered by different clinical specialties. Collaboration is required between clinical specialty and research teams. The aim of this study was...

    Sean Strong, Sangeetha Paramasivan, Nicola Mills, Caroline Wilson, Jenny L. Donovan and Jane M. Blazeby

    Trials 2016 17:212

    Published on: 26 April 2016

  14. Research

    Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals

    Recruiting and consenting women to peripartum trials can be challenging as the women concerned may be anxious, in pain, and exhausted; there may also be limited time for discussion and decision-making to occur...

    Julia Lawton, Claire Snowdon, Susan Morrow, Jane E. Norman, Fiona C. Denison and Nina Hallowell

    Trials 2016 17:195

    Published on: 11 April 2016

  15. Research

    Exploring non-participation in primary care physical activity interventions: PACE-UP trial interview findings

    Trials in primary care to increase physical activity (PA) typically experience poor recruitment rates and may not recruit those with lower PA levels and who are most in need of the intervention. Despite the we...

    Rebecca Normansell, Rebecca Holmes, Christina Victor, Derek G Cook, Sally Kerry, Steve Iliffe, Michael Ussher, Julia Fox-Rushby, Peter Whincup and Tess Harris

    Trials 2016 17:178

    Published on: 1 April 2016

  16. Methodology

    Why, when and how to update a meta-ethnography qualitative synthesis

    Meta-ethnography is a unique, systematic, qualitative synthesis approach widely used to provide robust evidence on patient and clinician beliefs and experiences and understandings of complex social phenomena. ...

    Emma F. France, Mary Wells, Heidi Lang and Brian Williams

    Systematic Reviews 2016 5:44

    Published on: 15 March 2016

  17. Research

    Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy)

    Surgical trials have typically experienced recruitment difficulties when compared with other types of oncology trials. Qualitative studies have an important role to play in exploring reasons for low recruitmen...

    Emily Harrop, John Kelly, Gareth Griffiths, Angela Casbard and Annmarie Nelson

    Trials 2016 17:35

    Published on: 19 January 2016

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