Table 1

Approach to data analysis and synthesis

1. Familiarising with qualitative dataInitially two complementary data-coding frameworks were developed for all interview and audiorecorded consent discussion data using broad a priori codes identified from initial reading related to the Consent Study aims and objectives including approach to recruitment and RWPC (please see our linked paper for further details of this stage 1 analysis (add reference to sister paper) .
Stage 2 analysis was then conducted for the 19 matched audiorecorded consent discussions and parental telephone interview data. LR listened to and read telephone interviews/transcripts and audiorecorded consent discussions/transcripts for each family and noted down initial ideas on themes.
2. Generating initial codesDuring the initial data familiarisation stage LR and KW identified data-driven codes and concepts. Analysis was based on a thematic analysis approach, a method for identifying, analysing and reporting patterns (or themes) within data.
3. Developing the coding frameworkWe then reflected on the Realpe framework and other data driven areas of interest from the stage 1 analysis and initial coding, to help organise matched data framework. We were interested in whether the health professional explained the uncertainty of the trial to the parents, gave the parents a balanced view of the two drugs, explained the study procedures well (eg, randomisation) and responded to questions and answers. LR organised data on each of these aspects of trial recruitment and other data-driven areas of interest. KW second coded 15% (n=3 matched data sets) of transcripts using a framework.
4. Defining and naming themesFollowing review and reconciliation, LR and KW revised and ordered themes and related data into steps in an excel spreadsheet. The sequence and content of steps involved consideration what parents prioritised when they described aspects of the trial and the trial discussion during interviews, as well as of how the absence/presence of a particular step in the audiorecorded discussion appeared to hinder/help parental understanding when explored during their interview with LR. Regular weekly or bi weekly meetings were held to discuss the developing framework over a 3-month period.
5. Completion of coding of transcriptsIn the final stage of analysis, LR considered the matched analysis framework (and related model) in reference to the wider data set (stage 1), which included an additional 11 interviews. This final stage aimed to ensure that the analysis and related model reflected aspects of recruitment and RWPC discussions that were important to all parents in the sample.
6. Write upLR and KW developed the initial manuscript. LR led the development of themes and KW developed the final model and manuscript write-up in collaboration with LR and MDL.
  • RWPC, research without prior consent.