Table Of ContentA Practical Guide to Using
Qualitative Research
with Randomized
Controlled Trials
A Practical
Guide to Using
Qualitative
Research with
Randomized
Controlled Trials
Alicia O’Cathain
Professor of Health Services Research
School of Health and Related Research (ScHARR)
University of Sheffield, Sheffield, UK
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Preface
Why the book is needed
It is by no means innovative to use qualitative research with randomized con-
trolled trials (RCTs) in the field of health research. There are excellent examples
in the research literature and also many insightful methodological reflections
that have moved the field forward over recent years. In some research com-
munities where researchers have long recognized the complexity of the inter-
ventions they are evaluating, the complexity of the environments in which
RCTs are undertaken, or the complexity of communities or patient groups with
whom health interventions are tested, this combination of two very different
approaches to research is the norm. In other research communities, the add-
ition of qualitative research to the world of RCTs may be viewed with suspi-
cion and wariness. The book is mainly targeted at the first research community
because even though it may be the norm to combine qualitative research and
RCTs, there has been little practical guidance on how best to do this. The book
may also be useful to the second research community, showing them why they
might want to use qualitative research with RCTs and how they might go about
doing this.
Although many researchers have combined qualitative research and RCTs,
few have focused on integration of qualitative and quantitative data and find-
ings in this context. Integration has been a neglected or invisible aspect of
mixed methods research more widely and so it is not surprising to find that it is
also invisible in this context. The book makes a unique contribution by filling
this gap, detailing when and how integration can occur between qualitative re-
search and RCTs.
The reach of the book
The book focuses on qualitative research, with its emphasis on subjectivity, flexi-
bility, open data collection, depth, and context, and the RCT, with its emphasis
on objectivity, standardization, measurement, and a key goal of bias reduction.
The stark differences between the two methodologies make their combination a
most interesting ‘extreme case’ of mixed methods research. Indeed the book sits
within a framework of mixed methods research and more specifically mixed
methods evaluation. Readers familiar with these areas will see similarities with
vi PRefACe
these wider frameworks and also see how the extreme differences between
qualitative research and RCTs provide some unique challenges.
The book focuses on combining qualitative research specifically with RCTs
rather than the wider endeavour of experimental designs. Researchers engaging
with pre- test post- test designs and controlled before and after studies in their
evaluations, rather than RCTs, may find a lot within the book to guide their
practice. The book focuses on RCTs because there is a research community of
‘triallists’ who live, sleep, and breath RCTs, and infrastructures such as clinical
trials units to support the design and delivery of RCTs. The rules and regula-
tions around RCTs present a particular challenge for qualitative research.
The book focuses on health research because the majority of RCTs are under-
taken in this field. Health is a wide and varied field including health services
research, public health, technology assessment, health promotion, nursing,
rehabilitation, primary care, global health, and many more. The combination
of qualitative research and RCTs is central to all of these sub- specialisms of
applied health research and the book draws on examples from across a wide
spectrum of them. Although the focus of the book is health, the combination of
qualitative research and RCTs is also highly relevant to social and educational
research.
The book is about how to use qualitative research when preparing for,
or undertaking, an RCT. The focus is on a range of RCT designs including pilot
and pragmatic RCTs. It does not explain how to do qualitative research or how
to do RCTs; these issues are addressed in other excellent books. The focus of the
book is how to undertake qualitative research in the specific context of RCTs.
Who should read the book
The book is written for researchers who undertake qualitative research before
or during an RCT. Researchers often design and deliver qualitative research
with RCTs without having studied how to do it because it tends not to be ad-
dressed in any detail at the graduate degree level (Masters or PhD). Researchers
tend to learn through experience when they get their first job in this area. For
this reason the book takes the reader through the process of a research study,
from design to reporting, offering practical advice at each step.
The book may also be useful to researchers leading RCTs so they can plan
well for the use of qualitative research with the RCT and understand the tasks
and resources needed by their colleagues to best do their job. Researchers ex-
perienced at undertaking qualitative research with RCTs may also get some-
thing from the book because it brings together a diverse range of guidance and
PRefACe vii
reflections in a single place. Researchers on funding panels, on editorial boards
of journals, and who review grant applications and journal articles that com-
bine qualitative research and RCTs may find the book helpful when making
decisions about the methodological rigour of the research in front of them.
Finally, graduate students (Masters and PhD level) may undertake qualita-
tive research before or during an RCT for their dissertation or thesis. The book
offers practical guidance and a wide-r eaching set of references within which to
embed any empirical work.
The author’s perspective
I will set out my beliefs and values here so readers can understand how these
have shaped the book. Readers may hold different views and therefore disagree
with some of the content of the book. I am happy with this—d iversity of views
can generate learning. My views are
◆ I think it is important to measure the effectiveness of interventions that
attempt to improve health. RCTs reduce confounding and bias when
measuring effectiveness. Because of this I support RCTs and do not attempt
to challenge the ‘RCT paradigm’. I do however recommend that researchers
think about how they undertake RCTs and consider innovative changes that
offer a better balance between the strengths and weaknesses of RCTs.
◆ I think that relying on RCTs (and accompanying economic modelling) as the
only source of evidence of effectiveness is highly problematic. I believe that
bringing other methods into play alongside RCTs, particularly qualitative re-
search, can generate more useful evidence of effectiveness than RCTs alone.
◆ I want researchers to think carefully about the value of combining qualitative
research with RCTs, to move beyond thinking about qualitative research as an
addition to RCTs and think about the evaluation as a whole with the qualitative
research and RCT as equally valued parts of it. The reality can be quite different,
with qualitative research viewed as an add-o n to the core of the evaluation—
the RCT. My language in the book may sometimes portray this latter dynamic
because this is the context in which I currently operate, but my goal is that re-
searchers practice within an ‘equally valued parts of an evaluation’ paradigm.
Language
The term ‘randomized controlled trial’ is used throughout the book and ab-
breviated to RCT. In some research communities and countries it is called a
‘randomized clinical trial’.
viii PRefACe
How to use the book
The book is written so that it is accessible to busy researchers and students who
are likely to be reading it in conjunction with other books and methodological
journal articles. It is short and easy to read with direction to further reading for
those interested in delving deeper into the various topics covered.
Each chapter offers an overview of the material to be covered to allow readers
to decide whether it is worthwhile reading the whole chapter. Key points are
summarized at the end of each chapter to allow readers to digest the learning
points quickly. Examples are described in most chapters within boxes to help
readers who learn through examples.
Overview of the book
The book is divided into three parts:
◆ Part 1 Introducing qualitative research in the context of RCTs: overview of
rationales, study designs and paradigms
◆ Part 2 Practical guidance for using qualitative research with RCTs
◆ Part 3 Engaging relevant stakeholders
Part 2 offers the practical guidance promised within title of the book. Each
chapter focuses on key steps when undertaking qualitative research in the
context of RCTs: writing a proposal, selecting research questions, collecting
data, analysing data, integrating qualitative and quantitative components, and
publishing. Part 1 is less about the practical side of doing this type of research—
it sets the scene for the practical aspects. Part 3 is focused on the human beings
we work closely with during our research and offers much practical advice to
ensure these interactions are positive and fruitful.
As another way of making the book a practical guide, at the end of each
chapter a small number of questions is listed to prompt readers to think about
the projects they are designing or undertaking.
Acknowledgements
A heart- felt personal thanks to James, family, and friends, who always asked
how the book was going. They made writing the book feel like an exciting
process.
Professional thanks to ScHARR at the University of Sheffield UK for
giving me study leave to write large parts of the book, Dr Vicki Plano Clark
for encouraging me to write the book, the UK Medical Research Council for
funding the methodological work that made the book possible, co- authors on
the QUART study which spawned the book, colleagues who read and com-
mented on chapters, and colleagues from around the world who do such won-
derful research through combining qualitative methods and RCTs.
