Things left unsaid: important topics that are not discussed between patients with systemic sclerosis, their carers and their healthcare professionals-a discourse analysis.

INTRODUCTION: Systemic sclerosis (SSc) is a rare condition that can be complicated by interstitial lung fibrosis (SSc-ILD)-a major cause of mortality. This study explored information and communication needs of patients with SSc-ILD and their carers to understand what they are and whether they are met. METHODS: Qualitative research was performed, including in-depth individual interviews and observed conversations between pairs of patients, physicians and nurses, and between patients and physicians discussing experiences of SSc-ILD. The study was performed in Germany, Italy, Spain, the UK and the USA. Participants included 42 SSc-treating physicians, 21 patients with diagnosed SSc-ILD, 16 specialist nurses and five carers. RESULTS: Prognosis and mortality were the main unspoken topics acknowledged by patients, carers and healthcare professionals. Patients and carers felt afraid to ask physicians about mortality, and most physicians reported avoiding the question because their duty was to give patients hope and avoid causing additional distress. Patients often felt unable to ask physicians about relationships, family and work because of time constraints or because they felt these were not topics physicians would be concerned about. Often, specialist nurses felt that they had insufficient knowledge to provide adequate support. CONCLUSION: Key topics, including mortality and prognosis, are rarely openly discussed, leaving patients uncertain and anxious about the future. By communicating about difficult but important topics, physicians and nurses could help patients and carers manage and plan their lives. This study shows that a multi-professional team-based communication approach is likely to better address patient needs and priorities. KEY POINTS: • Key topics in SSc or SSc-ILD, such as mortality and prognosis, are rarely openly discussed in clinical consultations. • By communicating difficult but important topics, physicians and nurses could help patients manage their disease and plan their lives. • A multi-professional team-based communication approach is likely to better address patient needs and priorities and could be easily implemented without the need for significant additional resources.

Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations.

Introduction Transparent collaborations between patient organisations (POs) and clinical research sponsors (CRS) can identify and address the unmet needs of patients and caregivers. These insights can improve clinical trial participant experience and delivery of medical innovations necessary to advance health outcomes and standards of care. We share our experiences from such a collaboration undertaken surrounding the SENSCIS® clinical trial (NCT02597933), and discuss its impact during, and legacy beyond, the trial.Summary We describe the establishment of a community advisory board (CAB): a transparent, multiyear collaboration between the scleroderma patient community and a CRS. We present shared learnings from the collaboration, which is split into three main areas: (1) the implementation and conduct of the clinical trial; (2) analysis and dissemination of the results; and (3) aspects of the collaboration not related to the trial.1. The scleroderma CAB reviewed and provided advice on trial conduct and reporting. This led to the improvement and optimisation of trial procedures; meaningful, patient-focused adaptations were made to address challenges relevant to scleroderma-associated interstitial lung disease patients.2. To ensure that results of the trial were accessible to lay audiences and patients, written lay summaries were developed by the trial sponsor with valuable input from the CAB to ensure that language and figures were understandable.3. The CAB and the CRS also collaborated to co-develop opening tools for medication blister packs and bottles. In addition, to raise disease awareness among physicians, patients and caregivers, educational materials to improve diagnosis and management of scleroderma were co-created and delivered by the CAB and CRS.Conclusions This collaboration between POs and a CRS, in a rare disease condition, led to meaningful improvements in patient safety, comfort and self-management and addressed information needs. This collaboration may serve as a template of best practice for future collaborations between POs, research sponsors and other healthcare stakeholders.