Our aim was to produce an intervention that replicated the experience of face-to-face physiotherapy breathing retraining in an accessible self-guided format. We acquired the media in a high-quality video file format to‘future-proof’ our content as much as possible and facilitate distribution using different technologies. The available technologies for distribution at the time of the original funding application were videotape, DVD and the internet. Although we knew that distributing video via the internet was possible, we chose the DVD as the distribution format for this project because, at the time, DVD players were becoming more popular and fewer people in the UK had access to the internet. In 2009 (when the funding application was written) the broadband network and hardware required to view internet-distributed video was not established or as widespread as it is now. Since then, distributing video via the internet has become ubiquitous. Reformatting our original video files for distribution via the internet will be relatively straightforward.
To enable people to identify with the patients seen on screen on the DVD, it was decided to involve genuine individuals with asthma (rather than actors) to take on the roles of patients. A local specialist respiratory physiotherapist (Denise Gibson) was asked to play the role of the breathing retraining physiotherapist. Dr Mark Porter (who has considerable experience of fronting medical programmes on both radio and television) kindly agreed to be the‘presenter’ for the DVD.
The DVD production team consisted of AB, MT and DG, the psychology team developing the booklet,
patient representatives, a commercial company (Zemedia) and staff at Solent University Studios, Southampton. AB produced a draft script for the DVD, based on a combination of the written Face-To-Face Protocol, the developing Breathing Freely booklet and discussions with physiotherapists. This was then shared with our psychology team members, patient representatives and others in the research team. Input from TMG patient representatives was of great importance in these revisions, and these representatives were involved in and commented on all revision steps, providing verbal and written comment on patient perspectives of the intervention. In addition, the iterative person-based think-aloud process for the development of digital
behavioural interventions that was used in the development process for this intervention (described in detail in Chapter 6) used a representative sample of 29 adults with asthma purposively sampled for diversity of age, sex, education and symptom profile. These patients looked at draft versions of the intervention and provided feedback and comment using a formal qualitative methodology, and this was used to modify the intervention based on their reactions and comments. Several revisions to the script were subsequently made in response to comments and feedback from within the team. A professional media production team (Zemedia) had been identified by AB in 2009 during the initial funding application process and its main representative (Tim O’Riordan) had been regularly attending project meetings from 2011. Zemedia were employed to translate our script into a filmable story, to film the scenes and to create and produce the final DVD. Script refinement and preparation for filming continued over the first year of the research programme, during which period there were several team meetings to agree on patient roles and locations and to design‘story boards’ for individual scenes. Filming took place over 3 days in May and June 2012, in Solent University Studios and on location in patients’ homes, with Steve Bowles of Zemedia and AB directing. Clips from the filming were shared within the research team for comment in terms of what to include/exclude, what voiceovers were appropriate and general formatting of the DVD. It was not felt appropriate to seek patient feedback on the developing DVD itself at that stage as it would not have been possible to refilm scenes because of time and financial constraints. Tim O’Riordan was responsible for the editing and post-production work that resulted in the final version of the DVD used in the trial. Feedback on the DVD as used by participants was sought as part of the research trial and is described elsewhere in this report.
Patient and public involvement (PPI) was central to this project, with two PPI representatives on the TMG attending TMG meetings and commenting on all stages of the process, and with the patient charity Asthma UK being a partner in the process. With the partnership of the charity and the active involvement of patients in all stages of the trial, in particular in the development and optimisation of the DVD intervention and booklet, we feel that there was complete PPI involvement overall. We did not experience any difficulty in obtaining PPI or in acting on it and would recommend that further trials in this clinical area integrate PPI into their processes as much as possible and involve patient charities if possible.
DOI: 10.3310/hta21530 HEALTH TECHNOLOGY ASSESSMENT 2017 VOL. 21 NO. 53
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Chapter 6 Process evaluation
I
n line with Medical Research Council (MRC) guidance for developing and evaluating complex interventions38and the MRC process evaluation framework,39qualitative and quantitative processevaluations were nested within the trial to allow for a more detailed exploration of aspects that may be relevant to trial outcomes that might inform policy and practice. The qualitative process evaluation was conducted after the BREATHE trial 3-month follow-up with a sample of participants who had taken part in the intervention arms of the trial, to capture their perspectives on the interventions and understand what aspects were perceived as strengths and weaknesses.
The aim of the quantitative process evaluation was to explore participants’ reported expectations of the interventions, their experiences and their level of engagement with the interventions. Measures for the quantitative process evaluation were taken immediately after randomisation and at each of the 3-month, 6-month and 12-month follow-up time points. Like the qualitative process evaluation, only those who had taken part in the intervention arms of the trial were included.
The methodology and findings of the qualitative and quantitative process evaluations are each reported in more detail in the following sections.