What can qualitative research do for randomised controlled trials? A systematic mapping review

Objective To develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. Design Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. Data sources MEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. Eligibility criteria Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. Results 296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. Conclusions A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit within their articles about the learning for trials and evidence-based practice.

[1]  M. Underwood,et al.  Influences on older people’s decision making regarding choice of topical or oral NSAIDs for knee pain: qualitative study , 2007, BMJ : British Medical Journal.

[2]  Claire Glenton,et al.  Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study , 2009, BMJ : British Medical Journal.

[3]  A. Ludbrook,et al.  Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial , 2009, BMJ : British Medical Journal.

[4]  A. Farmer,et al.  Designing and evaluating complex interventions to improve health care , 2007, BMJ : British Medical Journal.

[5]  C. Dowrick,et al.  Bmc Family Practice General Practitioners' Views on Reattribution for Patients with Medically Unexplained Symptoms: a Questionnaire and Qualitative Study , 2008 .

[6]  L. Abetz,et al.  Alzheimer’s disease treatment: Assessing caregiver preferences for mode of treatment delivery , 2009, Advances in therapy.

[7]  R. Byng,et al.  Exposing the key functions of a complex intervention for shared care in mental health: case study of a process evaluation , 2008, BMC health services research.

[8]  John W. Creswell,et al.  Mixed Methods Intervention Trials , 2009 .

[9]  Jenny Donovan,et al.  Quality improvement report , 2002, BMJ : British Medical Journal.

[10]  K. Malterud,et al.  Acupuncture for menopausal hot flashes: a qualitative study about patient experiences. , 2009, Journal of alternative and complementary medicine.

[11]  I. Higginson,et al.  The experience of using the SEIQoL-DW with patients with advanced chronic obstructive pulmonary disease (COPD): issues of process and outcome , 2010, Quality of Life Research.

[12]  Maria J Grant,et al.  A typology of reviews: an analysis of 14 review types and associated methodologies. , 2009, Health information and libraries journal.

[13]  C. Penn,et al.  Recommendations for communication to enhance informed consent and enrolment at multilingual research sites , 2009, African journal of AIDS research : AJAR.

[14]  M Sandelowski,et al.  Focus on qualitative methods: Using qualitative methods in intervention studies. , 1996, Research in nursing & health.

[15]  E. Halcomb,et al.  Mixed Methods Research for Nursing and the Health Sciences , 2009 .

[16]  S. Lees,et al.  A model for community representation and participation in HIV prevention trials among women who engage in transactional sex in Africa , 2008, AIDS care.

[17]  Nuria Romo,et al.  From illegal poison to legal medicine: a qualitative research in a heroin-prescription trial in Spain. , 2009, Drug and alcohol review.

[18]  T. Peters,et al.  Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study , 2002 .

[19]  N. Ahmed,et al.  Process evaluation of a school-based HIV/AIDS intervention in South Africa , 2009, Scandinavian journal of public health.

[20]  M. Petticrew,et al.  Developing and evaluating complex interventions: the new Medical Research Council guidance , 2008, BMJ : British Medical Journal.

[21]  A. Finset,et al.  "Four Habits" goes abroad: report from a pilot study in Norway. , 2008, Patient education and counseling.

[22]  E. Tutton,et al.  Fluid optimisation using a peripherally inserted central catheter (PICC) following proximal femoral fracture: Lessons learnt from a feasibility study , 2009 .

[23]  C. Chew‐Graham,et al.  Disclosure of symptoms of postnatal depression, the perspectives of health professionals and women: a qualitative study , 2009, BMC Family Practice.

[24]  Maria J. Grant.  Searching for qualitative research studies on the MEDLINE database : the development of an optimal search strategy , 2000 .

[25]  R. Chaisson,et al.  South African TB nurses' experiences of provider-initiated HIV counseling and testing in the Eastern Cape Province: a qualitative study , 2010, AIDS care.

[26]  F. Hu,et al.  Substituting brown rice for white rice to lower diabetes risk: a focus-group study in Chinese adults. , 2010, Journal of the American Dietetic Association.

[27]  D. Mant,et al.  Development and evaluation of complex interventions in health services research: case study of the Southampton heart integrated care project (SHIP) , 1999 .

[28]  Andrew Cole,et al.  Cancer expert doubts claims about prostate cancer trial , 2008, BMJ : British Medical Journal.

[29]  J Popay,et al.  Qualitative research and evidence-based healthcare , 1998, Journal of the Royal Society of Medicine.

[30]  R. Pill,et al.  Why do interventions work in some places and not others: a breastfeeding support group trial. , 2010, Social science & medicine.

[31]  Jennie Popay,et al.  Chapter 20: Qualitative research and Cochrane reviews , 2008 .

[32]  Elizabeth Allen,et al.  Process evaluation in randomised controlled trials of complex interventions , 2006, BMJ : British Medical Journal.

[33]  S. Gates,et al.  Response and non-response to postal questionnaire follow-up in a clinical trial--a qualitative study of the patient's perspective. , 2008, Journal of evaluation in clinical practice.

[34]  L. Spencer,et al.  Qualitative data analysis for applied policy research , 2002 .

[35]  A. Abernethy,et al.  Creating a Research Culture in a Palliative Care Service Environment: A Qualitative Study of the Evolution of Staff Attitudes to Research during a Large Longitudinal Controlled Trial (ISRCTN81117481) , 2008, Journal of palliative care.

[36]  V. Entwistle,et al.  Effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee: a mixed methods study of the feasibility of conducting a surgical placebo-controlled trial (the KORAL study). , 2010, Health technology assessment.

[37]  Tomoko Inoue,et al.  Searching for a way to live to the end: decision-making process in patients considering participation in cancer phase I clinical trials. , 2010, Oncology nursing forum.

[38]  T. Marteau,et al.  Maximising recruitment and retention of general practices in clinical trials: a case study. , 2008, The British journal of general practice : the journal of the Royal College of General Practitioners.

[39]  P. Sandercock,et al.  Framework for design and evaluation of complex interventions to improve health , 2000, BMJ : British Medical Journal.

[40]  Sara A Baker,et al.  Participant recruitment to a randomized trial of a community-based behavioral intervention for pre- and interconceptional women findings from the Central Pennsylvania Women's Health Study. , 2008, Women's health issues : official publication of the Jacobs Institute of Women's Health.