Search

Funding Acknowledgements National Institute for Health Research OnBehalf King"s Health Partners Patient & Public Involvement for Inherited Cardiac Conditions (PPIICC) group Background Inherited Cardiac Conditions (ICCs) affect up to 1:200 of the population and is the leading cause of sudden death in the under 40s. Research into developing interventions to support patients as they adjust to their diagnosis and genetic carrier status is underway; an example of which is the Psychoeducational Intervention Supporting patients with an ICC (PISICC) study. To ensure the appropriateness, acceptability and applicability of the intervention, patients and the public were involved in the development of PISICC intervention. Purpose To ensure the relevance and improve the quality of the PISICC study, Patient & Public Involvement for Inherited Cardiac Conditions (PPIICC) group was organised to guide the research project as this progressed through the three phases of the Medical Research Council framework for developing complex interventions. Methods Utilising INVOLVE guidelines, the PPIICC group was initiated by the researcher by inviting patients and families attending a local ICC clinic, members of the patient support group, Cardiomyopathy UK; and members of the existing PPI group of the local biomedical research centre. Ground rules, terms of engagement and provisions for meetings such as rooms, reimbursements for transport costs, childcare and compensation for time was established. The PPIICC group met up to three times per year within a three-year period with electronic exchanges in between. Members gave individual feedback to draft study materials and their views shaped the final versions. A modified Delphi study was used for the development of the PISICC intervention model. Figure 1 illustrates the activities undertaken by the group. Results The involvement of the PPIICC group throughout the development of the PISICC intervention model has contributed to the successful recruitment of 32 participants and completion of the qualitative study in Phase 1. In Phase 2 the group had a crucial role in ensuring that the education component of the PISICC intervention included advice on medication and physical activity; and for the group component of the intervention to include a mixed age group to enable sharing of varied experiences. In planning for Phase 3, the PPIICC group helped ensure that the trial processes for the planned feasibility study were not burdensome to participants which supported its full ethical approval by the UK Health Research Authority. Conclusions Patients and their families played an important role in designing the PISICC study. So far, their involvement has resulted in reaching recruitment targets for Phase 1 of the study, the development of a patient-informed psychoeducational intervention model and feasibility study protocol.

Background Long-term outcomes for individuals at risk of developing psychosis are heterogeneous; some develop a psychotic disorder, others continue to experience attenuated psychotic symptoms (APS) and some experience clinical remission and functional recovery. Existing UHR literature is primarily vulnerability- and disease-focused. In recent years, there has been a gradual shift in research to focus on more favourable outcomes, yet despite positive findings, very few UHR studies have directly investigated or even reported good outcomes in this population. Perhaps one major obstacle for this research is the lack of a sound definition of what constitutes a ‘good’ outcome for UHR individuals. The current study uses the Delphi method to systematically reach a consensus definition, amongst UHR clinical and research experts, of good outcome in this clinical population. To our knowledge, this is the first UHR-focused study to utilize the Delphi method. Methods A three-round online Delphi study was conducted and n=135 UHR-expert clinicians and researchers drawn from multiple continents were invited to take part. In Round 1, participants were asked to: i) select from a list of items those which they considered most important to the definition of good outcome in UHR and ii) make suggestions on ways in which good outcome could be determined in a standardised way. In Round 2, participants were asked rate the importance of each item to good outcome in UHR individuals, on a 5-point Likert scale. According to the proportion of participants who rated the items as ‘essential’ or ‘important’, items were: i) accepted as part of the consensus and included as a standard if rated by ≥80% or more of the group, ii) re-introduced in the third round and participants were given the opportunity to re-rate them if rated by between 50–79% of the group or iii) excluded if rated by less than 50% of participants. Results Forty-six (34.1%) participants responded to the first round of the Delphi process, 39 (84.7% retention rate) responded to Round 2, and 30 (76.9% retention rate) to Round 3. Of the 46 UHR-experts, 20 were psychiatrists, 17 were psychologists, 8 were researchers/lecturers and 1 was a social worker. Fifteen items were endorsed by ≥80% of the expert-participants as ‘essential’ or ‘important’ for defining UHR-specific good outcome at one-year follow-up. Items fell into one of the following categories: functioning, symptoms, other clinically relevant factors or personal wellbeing. ‘Daily functional capacity’ and and ‘self-reported improvement in mental health’ were rated as ‘essential’ to defining good outcome for an UHR individual at one-year, by 100% of the Delphi sample. A reduction in the distress associated with APS was deemed ‘important’ by 92.1% of the sample, more so than the complete remission of APS. Many similar items were rated with the same level of endorsement for the question on outcome at five-year follow-up. Twenty-one protective factors reached ≥80% endorsement for being essential or important for good outcome in UHR individuals and fell into at least one of the following categories: community support; mental health services support; cognitive factors; personal wellbeing; social network/support; substance use/abuse; daily living factors; and premorbid factors. Discussion This three-phase Delphi study achieved consensus on the core features of good outcome at one-year and five-years in the UHR population. The items that form this definition could be used in future research and clinically, to evaluate treatment and outcome of UHR individuals. They can also be of value to the development of intervention frameworks. Further studies involving other stakeholder groups, particularly individuals considered to be at risk of developing psychosis, are needed.