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Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

BMJ 2009; 339 doi: (Published 10 September 2009) Cite this as: BMJ 2009;339:b3496

Rapid Response:

This is relevant beyond trials of interventions in the organisation of care

Lewin and colleagues show the lack of attention paid to integration
of the qualitative research undertaken alongside randomised controlled
trials of organisational interventions, making the point that researchers
may be failing to exploit the potential of mixed methods research.1 This
has also been found when qualitative methods are used alongside trials of
other types of interventions and other quantitative methods.2 We undertook
a study of 75 mixed methods projects in health services research in
England and found that researchers may not integrate data or findings from
different components of their study, may not publish qualitative
components, or may publish each component in separate journals, sometimes
without reference to each other.2 This breaking up of a study into its
methodological pieces makes it hard for health professionals, policy
makers and patients to identify what can be learnt from a single research
project. Separate publication is often necessary due to the word limit of
journals but some researchers have found a way of publishing integration
within this constraint. A good model is the publication of one component
of a study first and then the publication of the second component can draw
on findings from the first publication within its introduction, results or
discussion to aid analysis or interpretation.3 We also interviewed 20
researchers and found that the way researchers use, integrate and report
methods is affected by their reasons for undertaking a mixed methods study
in the first place, how the researchers interact as a team, and structural
issues. Some researchers undertake mixed methods studies for strategic
reasons rather than the intrinsic value of combining methods e.g. they add
a qualitative component because they perceive that funding bodies will
like this, or to facilitate publication if the trial findings are null.4

Some research teams work as separate qualitative and quantitative teams in
a multidisciplinary fashion which leads to a lack of integration between
components; others meet frequently to share findings and interpretations
in an interdisciplinary way which can lead to publication of knowledge
accessed through integration of components.5 How researchers report their
studies can be determined by templates available within their community.6

If researchers see stand alone publications of different components of
studies then this perpetuates a lack of integration within studies. This,
along with other structural issues such as the lack of formal education
around ways of integrating data and findings, contributes to researchers
sometimes failing to deliver the promise of combining methods.7 Lewin and
colleagues also express concern about the quality of qualitative
components, and this too is relevant to wider mixed methods studies.8,9

This is by no means as depressing as it sounds. When we undertook our
study of mixed methods research, we found inspiring examples of
integration and publication of mixed methods studies. There is a need to
communicate these exemplars to the research community because we all learn
by seeing things done well.

1. Lewin S, Glenton C, Oxman DA. Use of qualitative methods alongside
randomised controlled trials of complex healthcare interventions:
methodological study. BMJ 2009; 339:b3496.

2. O'Cathain A, Murphy E, Nicholl J. Integration and publications as
indicators of 'yield' from mixed methods studies Journal of Mixed Methods
Research 2007;1(2):147-163.

3. Donovan JL, Peters TJ, Noble S, Powell P, Gillat D, Oliver SR, et
al. Who can best recruit to randomised trials? Randomised trial comparing
surgeons and nurses recruiting patients to a trial of treatments for
localized prostate cancer (the ProtecT study). Journal of Clinical
Epidemiology 2003;56:605-609.

4. O'Cathain A, Murphy E, Nicholl J. Why, and how, mixed methods
research is undertaken in health services research: a mixed methods study.
BMC Health Services Research 2007;7:85.

5. O'Cathain A, Murphy E, Nicholl J. Multidisciplinary,
interdisciplinary or dysfunctional? Team working in mixed methods
research. Qualitative Health Research 2008;18(11):1574-1585.

6. O'Cathain A. Reporting results. In: Andrew S, Halcomb E, editors.
Mixed methods research for nursing and the health sciences Blackwell
Publishing, 2009, pp 135-158.

7. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M.
Developing and evaluating complex interventions: the new Medical Research
Council guidance. BMJ 2008;337:a1655.

8. O'Cathain A, Murphy E, Nicholl J. The quality of mixed methods
studies in health services research. Journal of Health Services Research
and Policy 2008;13(2):92-98.

9.Pope C, Mays N. Critical reflections on the rise of qualitative
research. BMJ 2009;339:b3425.

Competing interests:
None declared

Competing interests: No competing interests

18 September 2009
Alicia O'Cathain
Senior Research Fellow
ScHARR, University of Sheffield, S1 4DA