Case study 3: Farquhar and colleagues [47] undertook a qualitative study to explore the feasibility, acceptability and appropriateness of a widely used quality of life instrument. This was undertaken within a pilot trial in preparation for a Phase III trial of a complex intervention for intractable breathlessness in patients with advanced chronic obstructive airways disease.

Research question: In the introduction of the paper the authors explain that it was important to explore the feasibility and acceptability of the instrument because it had not been used with this patient group.

Design and data collection: The instrument is administered in the context of an interview. Data collection for the qualitative study consisted of the audio-recordings of these interviews. 13 patients in the intervention and control arms of the pilot trial completed the instrument on 3-5 occasions each.

Analysis: Framework analysis was used and is referenced.

Reporting: Although not mentioned in the title of the paper, the authors are clear in the abstract that this qualitative research was undertaken in the context of a Phase II trial in preparation for a Phase III trial. The key words include ‘feasibility studies’. Within the methods section of the paper they state that the pilot trial was published elsewhere and give references so that readers can connect the different components of this study if required. The qualitative findings are described in detail using quotes from participants; they identify the difficulties participants had completing the instrument at different stages of the pilot trial. The authors state clearly in the conclusion section of the paper the implications of this work for both the full trial and for the future development of the instrument. The instrument was rejected for use in the full trial because of the difficulties identified.