Bloodstream infections (BSIs) are a major cause of morbidity and mortality worldwide. Although recent clinical trials have increasingly adopted patient-centred outcome measures, patient-informed selection of outcome measures remains limited in infectious disease research. Greater deliberate engagement and partnership with patients and families are required to ensure that outcomes reflect priorities that are meaningful to those with lived experience. Our study aims to incorporate patient-informed perspectives into outcome selection for BSI clinical trials.

We will undertake an exploratory sequential mixed methods study nested with the currently running international BALANCE+ trial of Gram-negative BSI (NCT06537609). All study materials will be co-developed and piloted with patient partners. Phase I will consist of virtual focus groups with past patient and family member participants of the BALANCE+ trial from intensive care and ward settings (total of 24–40 participants), using purposive sampling to maximise variation across demographic characteristics. Data will be audio-recorded and transcribed verbatim and analysed thematically using dual independent coding and consensus methods. Phase II will encompass development and administration of a survey (total ~100 respondents) to rank and prioritise outcomes identified in phase I, with responses descriptively summarised and integrated with qualitative findings. In phase III, virtual meetings with relevant parties including patients/families and investigators/study team members in the infectious disease field will be held to generate consensus-based recommendations and inform implementations with BALANCE+ and future trials.

Ethics approval has been obtained from the University of Calgary for all study activities and participating BALANCE+ sites to enable recruitment. Study findings will be disseminated through peer-reviewed publications, community engagement, conference presentations and integration into ongoing and future trials.

Sedation is commonly used in critically ill patients to facilitate procedures and care as well as provide comfort but can carry risks such as delirium and prolonged mechanical ventilation. Although current guidelines advocate for light sedation, sedation practices are influenced by clinicians’ subjective interpretations. Patients and families may experience distress and unmet needs, and little is known about their perspectives and experiences in the context of contemporary light sedation practices.

This study aimed to understand the perceptions and experiences of both patient and family members in the intensive care unit (ICU) of current sedation practices.

Canadian, closed, mixed ICU setting.

Critically ill adult patients and adult family members.

Patients and family members were interviewed, using a semi-structured interview questionnaire, and Braun and Clarke inductive thematic analysis was used to identify themes and subthemes in the data.

We conducted semi-structured interviews with 10 family members and 10 patients. Family members and patients reported that sedation was needed for patient comfort. Family members also described the need for sedation for patient and staff safety, as well as their own comfort. While both groups described sedation as necessary for enduring the medical procedures in the ICU, both groups reported concerns of sedation use, including negative physiological and cognitive patient outcomes. Patients and family members also recommended strategies for improving how sedation use is communicated in the ICU.

Perceptions and experiences of patient and families with sedation care practices in the ICU were multifaceted with both positive and negative outcomes reported including psychological and emotional concerns with sedation use. Key recommendations were provided for improving sedation practices with families emphasising the need for family-centred care and patients highlighting the need for self-determination.