Aspect of the trial | Qualitative research contribution in the feasibility study of the SAFER trial programme | Example |
---|---|---|
Intervention | ||
 Developing the intervention | - | - |
 Improving the intervention | ✓ | Informed decision to remove requirement to check heart rate parameters when a participant was set up with the screening device |
 Describing the intervention | ✓ | Described the form of the screening programme across different practices |
 Understanding how the intervention works: mechanisms of impact | ✓ | Identified drivers of screening uptake |
 Developing, refining or challenging theory | ✓ | Developed logic model of the intervention to inform programme theory |
 Understanding implementation | ✓ | Demonstrated the important and hidden role of practice receptionists in the trial |
 Exploring the feasibility of the intervention | ✓ | Highlighted practical aspects which impede patient and staff participation |
 Exploring the acceptability of the intervention | ✓ | Identified participant and health professional concerns about participants only receiving results if they had a ‘positive’ AF result |
 Understanding fidelity, reach and dose of the intervention | ✓ | Described the form of the screening programme across different practices |
 Identifying the value of the intervention | ✓ | Exposed patient and staff views on the importance of screening for and detecting AF |
 Identifying perceived benefits and  harms | ✓ | Described benefits and harms, both those articulated by participants and those seen in observations |
 Understanding the context in which the intervention is tested | ✓ | Analysed practice differences which affect trial processes |
Conduct | ||
 Identifying effective and efficient recruitment practices | ✓ | Contributed to improvements in recruitment processes (e.g. revisions to participant information, enhanced media coverage) |
 Improving retention of participants | ✓ | Suggested improvements to participant information based on participant feedback Highlighted the importance of brief feedback and a thank you message to be shared with practices and patients |
 Maximising diversity | ✓ | Identified challenges for some participants in engaging and understanding trial material; suggested changes to participant documents to increase the clarity of the message |
 Understanding impact on participants, practitioners, and researchers of the RCT | ✓ | Suggested changes to staff training and documentation to reduce burden on staff |
 Undertaking an RCT that is acceptable | ✓ | Improved participant information around selection of participants |
 Improving ethical conduct | ✓ | Highlighted potential confusion from participant information about the length of the screening programme Reinforced participant information about action to take in the event of symptoms |
 Adapting RCT procedures to fit local contexts | - | - |
Outcomes of the RCT | ||
 Selecting outcomes important to patients and practitioners | - | - |
 Understanding variation in outcomes | ✓ | Identified contributory reasons for differential uptake of screening between patient groups |
Measures in the RCT | ||
 Identifying the accuracy of proposed measures | - | - |
 Improving completion of outcome measures | ✓ | Clarified requirements for staff completing CRFs (case report forms) |
 Developing outcome measures | ✓ | Informed the timing and content of harms of screening questionnaires |
 Understanding the health condition in the RCT | ✓ | Contributed to an understanding of the burden of AF for patients |