Table 1.
Description, distribution, timing and examples of different uses of qualitative research with trials
| Category | Subcategory | Description | Frequency 356 (100%) in 296 articles N (%) | Timing: percentage of subcategory undertaken at pretrial stage | Example |
|---|---|---|---|---|---|
| Intervention content and delivery | 254 (71%) | ||||
| Intervention development | Pretrial development work relating to intervention content and delivery | 48 (13%) | 100 | Gulbrandsen et al (2008)16 planned to undertake a pragmatic RCT of ‘four habits’, a clinical communication tool designed and evaluated in the USA for use in Norway. They used mixed methods research to identify ways to tailor the intervention content to meet the needs of local healthcare practice. They undertook 3 focus groups with local physicians who had been given the intervention training. They confirmed cultural alignment and informed elements of the training programme for use in the planned trial. | |
| Intervention components | Exploring individual components of a complex intervention as delivered in a specific trial | 10 (3%) | 0 | Romo et al17 undertook an RCT of hospital-based heroin prescription compared with methadone prescription for long-term socially-excluded opiate addicts for whom other treatments had failed. The aim of the qualitative research was to explore patients’ and relatives’ experience of the intervention as delivered within the trial. They undertook in-depth semi-structured interviews with 21 patients receiving the intervention and paired family members. They identified the resulting medicalisation of addiction as a separate component of the intervention. | |
| Models, mechanisms and underlying theory development | Developing models, mechanisms of action and underlying theories or concepts relating to an intervention in the context of a specific trial | 23 (6%) | 4 | Byng et al (2008)18 as part of a cluster RCT of a multifaceted facilitation process to improve care of patients with long-term mental illness undertook interviews with 46 practitioners and managers from 12 cluster sites to create 12 case studies. They investigated how a complex intervention led to developments in shared care for people with long-term mental illness. They identified core functions of shared care and developed a theoretical model: linking intervention specific, external and generic mechanisms to improved healthcare. | |
| Perceived value and benefits of intervention | Exploring accounts of perceived value and benefits of intervention given by recipients and providers of the intervention | 42 (12%) | 7 | Dowrick et al (2008)19 as part of an RCT of reattribution training in general practice for use with patients with medically unexplained symptoms undertook semi-structured interviews with 12 practitioners participating in the trial to explore attitudes to reattribution training among practitioners. They identified perceived direct and indirect benefits, for example, increased confidence in working with this group of patients and crossover into chronic disease management and understanding of what GPs valued about the intervention was seen as a potential mechanism for increasing the successful implementation of the intervention. | |
| Acceptability of intervention in principle | Exploring stakeholder perceptions of the ‘in principle’ acceptability of an intervention | 32 (9%) | 25 | Zhang et al (2010)20 undertook a pretrial study in preparation for a community-based RCT of reduction of risk of diabetes through long-term dietary change from white to brown rice. They undertook a mixed methods study with focus groups of 32 non-trial participants to explore cultural acceptability and prior beliefs about brown rice consumption among potential intervention recipients. They identified the beliefs held about brown rice that made it an unacceptable intervention. The results provided valuable insights to guide the design of patient information for the planned trial. | |
| Feasibility and acceptability of intervention in practice | Exploring stakeholder perceptions of the feasibility and acceptability of an intervention in practice | 83 (23%) | 24 | Pope et al (2010)21 as part of a cluster RCT of provider-initiated HIV counselling and testing of tuberculosis patients in South Africa undertook focus groups involving 18 trial intervention providers after the trial results were known to explore the structural and personal factors that might have reduced the acceptability or feasibility of the intervention delivery by the clinic nurses. The RCT showed a smaller than expected effect and the qualitative research provided insights into contextual factors that could have reduced the uptake of HIV testing and counselling, including a lack of space and privacy within the clinic itself. | |
| Fidelity, reach and dose of intervention | Describing the fidelity, reach and dose of an intervention as delivered in a specific trial | 12 (3%) | 0 | Mukoma et al (2009)22 as part of a school-based cluster RCT of an HIV education programme to delay onset of sexual intercourse and increase appropriate condom use undertook direct classroom observations (26 in 13 intervention schools), 25 semi-structured interviews with teachers (intervention deliverers) and 12 focus groups with pupils (recipients). They explored whether the intervention was implemented as planned, assessed quality and variation of intervention at a local level, and explored the relationship between fidelity of implementation and observed outcomes. They showed that the intervention was not implemented with high fidelity at many schools, and that the quality of delivery, and therefore the extent to which students were exposed to the intervention (dose), varied considerably. Observation and interview data did not always concur with quantitative assessment of fidelity (teachers’ logs). | |
| Implementation of the intervention in the real world | Identifying lessons for ‘real world’ implementation based on delivery of the intervention in the trial | 4 (1%) | 0 | Carnes et al (2008)23 as part of an RCT comparing advice to use topical or oral NSAIDs for knee pain in older people undertook telephone interviews with 30 trial participants to explore patient reports of adverse events and expressed preferences for using one mode of analgesia administration over the other. The trial showed equivalence of effect of topical and oral NSAIDS for knee pain. In the light of these findings, the qualitative research provided a model incorporating trial findings and patient preferences into decision-making advice for use in practice, as well as contributed to an empirically-informed lay model for understanding the use of NSAIDS as pain relief. | |
| Trial design, conduct and processes | 54 (15%) | ||||
| Recruitment and retention | Identifying ways of increasing recruitment and retention | 11 (3%) | 18 | Dormandy et al (2008)24 as part of a cluster trial of screening for haemoglobinopathies interviewed 20 GPs in the trial to explore why general practices joined the trial and stayed in it. They identified how to overcome barriers to recruitment in future trials in primary care. | |
| Diversity of participants | Identifying ways of broadening participation in a trial to improve diversity of population | 7 (2%) | 14 | Velott et al (2008)25 as part of a trial of a community-based behavioural intervention in interconceptional women undertook 2 focus groups with 4–6 facilitators and 13 interviews with trial recruitment facilitators to document strategies used and offer perceptions of success of strategies to recruit low income rural participants. They ensured inclusion of a hard to reach group in the trial. | |
| Trial participation | Improving understanding of how participants join trials and experience of participation | 4 (1%) | 25 | Kohara and Inoue (2010)26 as part of a cancer phase I clinical trial of an anticancer drug used qualitative research to reveal the decision making processes of patients participating in or declining a trial. They undertook interviews with 25 people who did and did not participate and observation of six recruitments and identified how recruiters could be more sensitive to patients. | |
| Acceptability of the trial in principle | Exploring stakeholders’ views of acceptability of a trial design | 5 (1%) | 60 | Campbell et al (2010)27 in relation to a proposed trial of arthroscopic lavage vs a placebo-surgical procedure for osteoarthritis of the knee undertook focus groups and 21 interviews with health professionals and patients to describe attitudes of stakeholders to a trial. In principle, the trial was acceptable, but placebo trials were not acceptable to some stakeholders. | |
| Acceptability of the trial in practice | Exploring stakeholders’ views of acceptability of a trial design in practice | 4 (1%) | 25 | Tutton and Gray (2009)28 as part of a feasibility trial of fluid optimisation after hip fracture undertook two focus groups with 17 staff and an interview with the research nurse to increase knowledge of implementation of the intervention and feasibility of the trial. They identified difficulty while recruiting for the trial in a busy healthcare environment. | |
| Ethical conduct | Strengthening the ethical conduct of a trial, for example, informed consent procedures | 16 (4%) | 12 | Penn and Evans (2009)29 as part of a community vs clinic-based antiretroviral medication in a multisite trial in South Africa undertook observation and interviews with 13 recruiters and 19 students going through two different informed consent processes in order to understand the effectiveness of using a modified informed consent process rather than a standard one. They identified ways of improving ethics and reducing anxiety when enrolling people in such trials. | |
| Adaptation of trial conduct to local context | Addressing local issues which may impact on the feasibility of a trial | 2 (1%) | 50 | Shagi et al (2008)30 as part of a feasibility study for an efficacy and safety phase III trial of vaginal microbicide undertook participatory action research, including interviews and workshops, to explore the feasibility of a community liaison system. They reported on improving the ethical conduct, recruitment and retention for the main trial. | |
| Impact of trial on staff, researchers or participants | Understanding how the trial affects different stakeholders, for example, workload | 5 (1%) | 20 | Grbich et al (2008)31 as part of a factorial cluster trial of different models of palliative care including educational outreach and case conferences undertook qualitative research to explore the effect of the trial on staff. They undertook a longitudinal focus group study (11 in total) with staff delivering the intervention and collecting the data at three time points during the trial. The reported impact on the trial was improved trial procedures and keeping people on board with the trial. | |
| Outcomes | 5 (1%) | ||||
| Breadth of outcomes | Identifies the range of outcomes important to participants in the trial | 1 (<1%) | 0 | Alraek and Malterud (2009)32 as part of a pragmatic RCT of acupuncture to reduce symptoms of the menopause used written answers to an open question on a questionnaire to 127 patients in an intervention arm to describe reported changes in health in the acupuncture arm of the trial, concluding that the range of outcomes in the trial were not comprehensive. | |
| Variation in outcomes | Explains differences in outcomes between clusters or participants in a trial | 4 (1%) | 0 | Hoddinott et al (2010)33 in a cluster RCT of community breastfeeding support groups to increase breastfeeding rates undertook 64 ethnographic in-depth interviews, 13 focus groups and 17 observations to produce a locality case study for each of 7 intervention clusters. Explained variation in the 7 communities and why rates decreased in some as well as increased in others. | |
| Measures of process and outcome | 10 (3%) | ||||
| Accuracy of measures | Assesses validity of process and outcome measures in the trial | 7 (2%) | 43 | Farquhar et al (2010)34 in a phase II pilot RCT of breathlessness intervention for chronic obstructive pulmonary disease used qualitative research to explore the feasibility of using an outcome measure for the main trial. They used longitudinal interviews with 13 patients in the intervention arm on 51 occasions and recordings of participants completing a questionnaire. They rejected the use of the outcome measure for the main trial because of lack of validity in this patient group. | |
| Completion of outcome measures | Explores why participants complete measures or not | 1 (<1%) | 0 | Nakash et al (2008)35 within an RCT of mechanical supports for severe ankle sprains used qualitative research to examine factors affecting response and non-response to a survey measuring outcomes. They undertook interviews with 22 participants, 8 of whom had not responded, and identified reasons for non-response such as not understanding the trial and feeling fully recovered. | |
| Development of outcome measures | Contributes to the development of a new process and secondary outcome measures | 2 (1%) | 0 | Abetz et al (2009)36 within a double-blind placebo RCT of patch treatment in Alzheimer's disease used qualitative research to identify items for an instrument for use in their RCT and check the acceptability of a developed questionnaire on career satisfaction. They undertook 3 focus groups with 24 careers prior to the RCT to identify items and 10 cognitive interviews during the RCT to contribute to assessment of the validity of measures used. | |
| Target condition | Experience of the disease, behaviour or beliefs | Explores the experience of having or treating a condition that the intervention is aimed at, or a related behaviour or belief | 33 (9%) | 6 | Chew-Graham et al (2009)37 within a pragmatic RCT of anti-depressants vs counselling for postnatal depression undertook qualitative research to explore patient and health professional views about disclosure of symptoms of postnatal depression. They undertook interviews with 61 staff and patients from both arms of the trial, offering reflections on implications for clinical practice in this patient group. |
GPs, general practitioners; NSAIDs, non-steroidal anti-inflammatory drugs; RCT, randomised controlled trial.