1、A Practical Guide toUsing Qualitative Research withRandomized ControlledTrials 1A Practical Guide toUsing Qualitative Research with Randomized ControlledTrialsAlicia OCathainProfessor of Health Services ResearchSchool of Health and Related Research(ScHARR)University of Sheffield,Sheffield,UK 1Great
2、Clarendon Street,Oxford,OX26DP,United KingdomOxford University Press is a department of the University of Oxford.It furthers the Universitys objective of excellence in research,scholarship,and education by publishing worldwide.Oxford is a registered trade markofOxford University Press in the UK and
3、in certain other countries Oxford University Press2018The moral rights of the author have been assertedFirst Edition published in 2018Impression:1All rights reserved.No part of this publication may be reproduced,storedina retrieval system,or transmitted,in any form or by any means,withouttheprior pe
4、rmission in writing of Oxford University Press,or as expressly permittedby law,by licence or under terms agreed with the appropriate reprographicsrights organization.Enquiries concerning reproduction outside the scopeoftheabove should be sent to the Rights Department,Oxford University Press,attheadd
5、ressaboveYou must not circulate this work in any otherformand you must impose this same condition on any acquirerPublished in the United States of America by Oxford UniversityPress198 Madison Avenue,NewYork,NY 10016,United States of AmericaBritish Library Cataloguing in PublicationDataData available
6、Library of Congress Control Number:2017959068ISBN 978 0 19 880208 2Printed and boundbyCPI Group(UK)Ltd,Croydon,CR0 4YYOxford University Press makes no representation,express or implied,thatthedrug dosages in this book are correct.Readers must therefore alwayscheckthe product information and clinical
7、 procedures with the most up-to-datepublished product information and data sheets provided by the manufacturersand the most recent codes of conduct and safety regulations.The authorsandthe publishers do not accept responsibility or legal liability for any errorsinthetext or for the misuse or misappl
8、ication of material in this work.Exceptwhereotherwise stated,drug dosages and recommendations are for the non-pregnantadult who is not breast-feedingLinks to third party websites are provided by Oxford in good faithandfor information only.Oxford disclaims any responsibility for the materialscontaine
9、d in any third party website referenced in thiswork.PrefaceWhy thebook isneededIt 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 methodologi
10、cal 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 patien
11、t 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 re
12、search 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
13、 they might go about doingthis.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
14、 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 andRCTs.The reach ofthebookThe book focuses on qualitative research,with its emphasis on subjectivi
15、ty,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
16、 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 PRefACevithese wider frameworks and also see how the extreme differences between qualitative research and RCTs provide some unique c
17、hallenges.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 boo
18、k 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
19、 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 mo
20、re.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 releva
21、nt to social and educational research.The book is about how to use qualitative research when preparing for,orundertaking,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
22、 other excellent books.The focus of the book is how to undertake qualitative research in the specific context ofRCTs.Who should read thebookThe book is written for researchers who undertake qualitative research before or during an RCT.Researchers often design and deliver qualitative research with RC
23、Ts 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
24、study,from design to reporting,offering practical advice at eachstep.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-pe
25、rienced at undertaking qualitative research with RCTs may also get some-thing from the book because it brings together a diverse range of guidance and PRefACeviireflections in a single place.Researchers on funding panels,on editorial boards of journals,and who review grant applications and journal a
26、rticles that com-bine qualitative research and RCTs may find the book helpful when making decisions about the methodological rigour of the research in front ofthem.Finally,graduate students(Masters and PhD level)may undertake qualita-tive research before or during an RCT for their dissertation or th
27、esis.The book offers practical guidance and a wide-reaching set of references within which to embed any empiricalwork.The authors perspectiveI 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
28、 some of the content of the book.Iam happy with this diversity of views can generate learning.My viewsare Ithink 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 Isupport RCTs an
29、d do not attempt to challenge the RCT paradigm.Ido however recommend that researchers think about how they undertake RCTs and consider innovative changes that offer a better balance between the strengths and weaknesses ofRCTs.Ithink that relying on RCTs(and accompanying economic modelling)as the onl
30、y source of evidence of effectiveness is highly problematic.Ibelieve that bringing other methods into play alongside RCTs,particularly qualitative re-search,can generate more useful evidence of effectiveness than RCTsalone.Iwant researchers to think carefully about the value of combining qualitative
31、 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-on to the core of
32、the evaluation the RCT.My language in the book may sometimes portray this latter dynamic because this is the context in which Icurrently operate,but my goal is that re-searchers practice within an equally valued parts of an evaluation paradigm.LanguageThe term randomized controlled trial is used thr
33、oughout the book and ab-breviated to RCT.In some research communities and countries it is called a randomized clinical trial.PRefACeviiiHow touse thebookThe 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 m
34、ethodological 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 cha
35、pter.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 ofthebookThe book is divided into threeparts:Part1 Introducing qualitative researc
36、h in the context of RCTs:overview of rationales,study designs and paradigms Part2 Practical guidance for using qualitative research withRCTs Part3 Engaging relevant stakeholdersPart2 offers the practical guidance promised within title of the book.Each chapter focuses on key steps when undertaking qu
37、alitative research in the context of RCTs:writing a proposal,selecting research questions,collecting data,analysing data,integrating qualitative and quantitative components,and publishing.Part1 is less about the practical side of doing this type of research it sets the scene for the practical aspect
38、s.Part3 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 reade
39、rs to think about the projects they are designing or undertaking.AcknowledgementsA 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 f
40、or 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
41、on chapters,and colleagues from around the world who do such won-derful research through combining qualitative methods andRCTs.ContentsAbbreviations xiiiPart1 Introducing qualitative research with RCTs:overview of rationales,study designs,and paradigms 1 Rationales for using qualitative research wit
42、h RCTs 3 2 Frameworks,study designs,and guidance 16 3 How qualitative research can contribute to generating evidence of effectiveness 28 4 Using qualitative research with different types of RCTs 42 5 Paradigms 55 6 Theories underpinning the intervention 65Part2 Practical guidance for using qualitati
43、ve research withRCTs 7 Writing a proposal 79 8 Selecting research questions 88 9 Collecting data 97 10 Analysing the qualitative data 112 11 Integrating qualitative and quantitative data and findings 119 12 Publishing journal articles 141 13 Assessing the quality of qualitative research undertaken w
44、ith RCTs 151Part3 Engaging relevant stakeholders 14 Team working 159 15 Engaging with key stakeholders 167 16 Having an impact on health,health care,and health policy 177References 183Index 199 AbbreviationsGP General practitionerHIV Human immunodeficiencyvirusMRC Medical Research CouncilNHS Nationa
45、l Health ServiceNIHR National Institute for Health ResearchPPI Patient and public involvementQUART QUAlitative Research inTrialsQUARTER2 Qualitative Research with Trials:Excellent Reporting version2RCT Randomized controlledtrialRE-AIM Reach,Efficacy,Adoption,Implementation,and MaintenanceSMARTs Sequ
46、ential multiple assignment randomizedtrialsTB TuberculosisUK United KingdomUSA United States of America Part1Introducing qualitative research withRCTs:overview ofrationales,study designs,and paradigms Chapter1Rationales forusing qualitative research withRCTsOverviewRead this chapter to learnabout De
47、finitions of qualitative research and randomized controlled trials(RCTs)Types of interventions where qualitative research is most relevant Reasons for using qualitative research withRCTs When not to use qualitative research withRCTs Relevance of qualitative research to different fields of health res
48、earch1.1 IntroductionIt is common to hear researchers say they will undertake qualitative research to explain the results of the trial.This chapter is about the wide range of reasons why it is important to use qualitative research with RCTs.Before addressing these,definitions of qualitative research
49、 and RCTs aregiven.1.2 Definitions ofqualitative researchThere is no single accepted definition or set of beliefs about qualitative research but rather a variety of understandings held by different academic disciplines,research communities,and individual researchers.Some researchers may dis-agree wi
50、th the definitions given below but they have been deliberately selected because of their relevance to researchers engaged with the production of an evidence base to improve health and healthcare.While reflecting on the contribution of qualitative research to evidence-based medicine and health care,B
