Involvement of patients and carers was identified at the outset as a priority for this research.
In workstream 1, two patient representatives contributed to the design of documentation for the cohort study and provided their perspective on study processes, questions and data interpretation through attendance at associated workstream meetings. A dedicated section of the meeting was devoted to patient feedback and the meeting was followed by an informal discussion between the research lead, a study research nurse and the patient representatives. When possible, any comments received from the patient representatives were incorporated into relevant study documentation or procedures. A newsletter to inform participants about the progress of the research was initiated by the patient representatives who assisted in the design and review of this document.
In workstream 3, the input of patient and carer representatives was crucial in the design and piloting of the interview topic guide, and the interpretation of the findings arising from the qualitative interviews, including review of the main study findings and input into the writing of the results. A summary of the results of the qualitative work was subsequently sent to participants, following review by the patient representatives.
Patient and carer involvement for this programme of work culminated in the development of a ‘Patient User Group’, convened at the start of workstream 4. This group was developed, following experiences in workstream 1, to increase the number of patient representatives involved and so reduce any burden on the two initial representatives involved. Ten patients or carers with experience of SWHSIs were invited to attend the inaugural meeting in March 2015, with five representatives subsequently attending. This resulted in a diverse group, with a mix of age, sex, SWHSI history and previous research experience. A further two meetings were convened during workstream 4 to provide comment on patient-facing documentation and study procedures and to discuss the interpretation of the results of the pilot, feasibility RCT. As in workstream 1, when possible, any comments received from the patient representatives were incorporated into study documentation or procedures. One member of the group was subsequently recruited to act as a patient and public representative for the workstream 4 Management Group meetings. The member provided a patient perspective on the trial processes and documentation, and made substantial contributions. This patient representative also contributed to and reviewed the summary of workstream 4 for this report and the associated papers arising from this workstream. In addition, a lay representative was also included in the workstream 4 Data Monitoring and Ethics Committee to provide patient input on data quality and patient safety and to advise on any issues arising during the trial.
The inclusion of patient and carer representatives has been instrumental in shaping this research programme and will undoubtedly be beneficial in shaping future research in this area. The mix of patients and carers providing input to the individual workstreams and in the Patient User Group provided the research programme team with a diverse range of experiences to draw on and consider when making decisions in relation to this research programme. Given the number of patient and public members involved in the various stages of this programme, there was naturally a range of views noted regarding patient and carer experiences, study procedures and documentation; however, in the vast majority of cases there was a consensus of opinion regarding progression of this research.