Table 3 Guidance for researchers and commissioners on writing proposals for the qualitative research undertaken with trials

Aim

Describe the aim of the qualitative research. Where appropriate identify aims specific to the trial e.g. ‘to explore patient views on adherence to the trial intervention’ rather than using general aims e.g. ‘to explore patient experiences’.

Rationale

Describe the rationale for including qualitative research; identify areas of uncertainty to be explored. Include a statement addressing the ways in which the aims of the qualitative research will ‘add value’ to the trial.

Methods

Provide a clear account of the proposed methods of data collection including the location and timing of data collection, and the skills and seniority of the person who will undertake data collection.

Describe the sample frame, sampling method(s), and sample size. Where the sample frame is trial participants, specify whether intervention, control or both will be included.

Describe and reference the proposed approach to analysis. A rationale for the approach to be taken may be included.

Identify the qualitative research skills and seniority of the person who will undertake the analysis and write-up.

Integration with trial

Outline suggestions for integrating and synthesising qualitative data / findings with the trial results.

Costs

Describe the full costs of the qualitative research and highlight any dedicated equipment, software, staff, and transcription costs.

Leadership

Identify which of the co-applicants will take overall responsibility for the qualitative research and describe their role in the design, data collection, analysis and write-up of the study.