Table 2 Questions that qualitative researcha can address in a feasibility study for a randomised controlled trial
Category of question | Sub-category | Examples of possible questions |
|---|---|---|
Intervention content and delivery | Intervention development | To what extent does the planned intervention need to be refined or adapted to make it more acceptable to users or more relevant or useful to the specific context in which it is delivered? |
Intervention components | Consider the different aspects of the intervention and which are fixed and flexible. The intervention may be different in practice from the planned intervention and may need to be documented so it can be delivered consistently in the full trial. | |
Mechanisms of action | How might the intervention be working? How might it produce the outcomes important to the trial? Data collected to address these questions may be interpreted in relation to the theory upon which the intervention is based or may help to develop new theory. | |
Perceived value, benefits, harms or unintended consequences of the intervention | What value do service providers and intervention users place on the intervention and the outcomes it plans to deliver? What benefits and harms do they feel they have experienced from the intervention so that these can be measured in the full trial? | |
Acceptability of intervention in principle | Are service users or health care providers unhappy with any aspect of the content or delivery of the intervention? | |
Feasibility and acceptability of intervention in practice | What are service users or health care providers’ views of the implementation of the intervention? Has implementation varied by setting? Are there any important intervention-context interactions? Should implementation be tailored by setting? | |
Fidelity, reach and dose of intervention | Is the right amount of the intervention getting to the right recipients in the right way? Do those delivering the intervention and/or receiving it adhere to the planned intervention? If not, what are the reasons for this? What are the limits of acceptable tailoring of the intervention? | |
Trial design, conduct and processes | Recruitment and retention | How do the planned recruitment practices work in the field? Do recruitment practices need to be improved to increase recruitment rates and levels of informed consent? If so, how? Are the trial participants willing to be randomised? Are clinicians willing to recruit patients, or are they uncomfortable? Are there ways in which trial procedures could be improved to increase retention rates? |
Diversity of participants | Are the planned recruitment practices likely to result in recruitment of the desired range of participants for the trial? If not, how might recruitment practices be improved? | |
Trial participation | How is the planned trial communication implemented by recruiters and received by participants? How can trial communication be improved to ensure recruiters understand patients’ views about participating in the trial? | |
Acceptability of the trial in principle | Is the trial design acceptable to patients, recruiters and service providers in principle? | |
Acceptability of the trial in practice | Is the trial design acceptable to patients, recruiters and service providers in practice, or are there ways in which participants try to alter the procedures? | |
Ethical conduct | Are the informed consent procedures appropriate and acceptable to likely trial participants? | |
Adaptation of trial conduct to local context | Will the planned trial procedures allow the trial to operate effectively in the proposed context? Do any changes need to be made to these procedures? | |
Impact of trial on staff, researchers, participants and the health system | Does this trial have any unanticipated negative impacts on recruiters, participants, other stakeholders and the health system? How can these impacts be minimised (e.g. workload involved in recruitment, numbers of measures undertaken)? | |
Patient and public involvement | How is patient and public involvement best achieved in the trial? | |
Outcomes | Breadth and selection of outcomes | Are outcomes important to service users selected for measurement in the full trial—both primary and secondary? Do some trial participants feel that they have experienced or noticed improvements in some outcomes that need to be included in the full trial? |
Measures | Accuracy of measures | Are the process and outcome measures valid for this participant group? |
Completion of measures | Can completion rates of measures be improved? | |
Development of measures | If validated measures do not exist for all the outcomes to be measured in the full trial, can they be developed in preparation for the trial? |