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Table 1 Qualitative research contribution in the feasibility study of the SAFER trial programme

From: How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme

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
  1. The aspects of the trial listed in the first column of this table come from the ‘aspects of an RCT’ framework by O’Cathain and colleagues [30, 34]