Patient and public involvement in contemporary large intensive care trials: A meta-epidemiological study.

BACKGROUND: Patient and public involvement in randomised clinical trials has received increased focus, including in intensive care trials, but the frequency, method and extent is unknown. This meta-epidemiological study investigated patient and public involvement in contemporary, large ICU trials. METHODS: We systematically searched PubMed for large (≥225 randomised patients), contemporary trials (published between 1 January 2019 and 31 January 2022) assessing interventions in adult patients in ICU settings. Abstracts and full-text articles were assessed independently and in duplicate. Data were extracted using a pre-defined, pilot-tested data extraction form with details on trials, patient and public involvement including categories and numbers of individuals involved, methods of involvement, and trial stage(s) with involvement. Trials authors were contacted as necessary. RESULTS: We included 100 trials, with 18 using patient and public involvement; these were larger and conducted in more centres than trials without patient and public involvement. Among trials with patient and public involvement, patients (in 14/18 trials), clinicians (13 trials), and family members (12 trials) were primarily involved, mainly in the development of research design (15 trials) and development of research focus (13 trials) stages and mostly by discussion (12 trials) and solo interviews (10 trials). A median of 65 individuals (range 1-6894) were involved. CONCLUSIONS: We found patient and public involvement in a fifth of large, contemporary ICU trials. Primarily patients, families, and clinicians were included, particularly in the trial planning stages and mostly through interviews and discussions. Increased patient and public involvement in ICU trials is warranted.

Struggling to return to everyday life-The experiences of quality of life 1 year after delirium in the intensive care unit.

BACKGROUND: Many critically ill patients report a change in their health-related quality of life after intensive care unit (ICU) discharge. Patients who experience delirium during their ICU stay are perceived as a fragile group of ICU survivors, and the 'quality of life' phenomenon needs to be studied among these patients. AIM: To explore everyday life experiences of critically ill patients with delirium during the ICU stay, from ICU discharge until 1-year follow-up, focusing on their health-related quality of life and cognitive function. STUDY DESIGN: We used a descriptive qualitative research design and interviewed patients 1 year after ICU admission. The participants were recruited from a pre-planned one-year follow-up study of 'Agents Intervening against Delirium for patients in the Intensive Care Unit trial'. Data were analysed using Framework Analysis Method and content analysis. RESULTS: Nine women and eight men participated and reported a struggle when returning to everyday life or adapting to a new normality from hospital discharge to 1 year later. None of the participants had been aware of the challenges they would face after hospital discharge. They described a need for more information about these challenges to themselves and about primary care to better understand their situation and the struggles they experience during recovery. One overall theme emerged from the analysis 'From enduring to adapting' with three subthemes: 'Struggling to regain a functional life', 'Struggling to regain normal cognition' and 'Distressing manifestations from the ICU'. CONCLUSIONS: To improve recovery and the quality of rehabilitation for critically ill patients suffering from delirium, it is essential to understand the phenomenon of ICU survivorship and what this fragile group of patients is going through. It is necessary to bridge the gap between secondary and primary care so patients can receive optimal training and support when needed. RELEVANCE TO CLINICAL PRACTICE: Bridging the gap between primary and secondary healthcare services is urgently needed to improve rehabilitation for ICU survivors after critical illness.

Development of a core outcome set for general intensive care unit patients-A protocol.

INTRODUCTION: Different outcomes are reported in randomised clinical trials (RCTs) in intensive care unit (ICU) patients, and no core outcome set (COS) is available for ICU patients in general. Accordingly, we aim to develop a COS for ICU patients in general. METHODS: The COS will be developed in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Handbook, using a modified Delphi consensus process and semi-structured interviews involving adults who have survived acute admission to an ICU, family members, clinicians, researchers and other stakeholders. The modified Delphi process will include two steps. Step 1: conduction of a modified Delphi survey, developed and informed by combining the outputs of a literature search of outcomes in previous COSs and semi-structured interviews with key stakeholders. We plan at least two survey rounds to obtain consensus and refine the COS. Step 2: a consensus process regarding instruments or definitions to be recommended for the measurements of the outcomes selected in Step 1. A 'patient and public involvement panel' consisting of a smaller group of patients, family members, clinicians and researchers will be included in the development, analysis and interpretation of the COS. DISCUSSION: The outlined multiple method studies will establish a COS for ICU patients in general, which may be used to increase the standardisation and comparability of results of RCTs conducted in patients in the ICU setting.

Patient and public involvement in contemporary large intensive care trials: Protocol for a meta-epidemiological study.

BACKGROUND: Patient and public involvement (PPI) in randomized clinical trials (RCTs) has increased in recent years but remains the exception rather than the rule. We aim to assess the frequency and extent of PPI in large, contemporary RCTs conducted in an intensive care setting. METHODS AND DESIGN: We will conduct a meta-epidemiological study of RCTs conducted in intensive care settings published since 2019 and assess their use of PPI. We will extract trial characteristics and verify the use of PPI with trial authors unless specifically stated in the published paper. The primary outcome will be the proportion of trials that use PPI. Secondary outcomes will explore which groups are consulted, at which stage of the trial process this occurs, and by what means these opinions are collected and implemented. DISCUSSION: This meta-epidemiological study will provide an important insight into the use of PPI in large, contemporary intensive care trials. We wish to reveal ways in which patient involvement could be incorporated more broadly and purposefully here and help to empower clinicians, researchers and patients to collaborate further on future research processes and goals.

Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium.

PURPOSE: We assessed long-term outcomes in acutely admitted adult patients with delirium treated in intensive care unit (ICU) with haloperidol versus placebo. METHODS: We conducted pre-planned analyses of 1-year outcomes in the Agents Intervening against Delirium in the ICU (AID-ICU) trial, including mortality and health-related quality of life (HRQoL) assessed by Euroqol (EQ) 5-dimension 5-level questionnaire (EQ-5D-5L) index values and EQ visual analogue scale (EQ VAS) (deceased patients were assigned the numeric value zero). Outcomes were analysed using logistic and linear regressions with bootstrapping and G-computation, all with adjustment for the stratification variables (site and delirium motor subtype) and multiple imputations for missing HRQoL values. RESULTS: At 1-year follow-up, we obtained vital status for 96.2% and HRQoL data for 83.3% of the 1000 randomised patients. One-year mortality was 224/501 (44.7%) in the haloperidol group versus 251/486 (51.6%) in the placebo group, with an adjusted absolute risk difference of - 6.4%-points (95% confidence interval [CI] - 12.8%-points to - 0.2%-points; P = 0.045). These results were largely consistent across the secondary analyses. For HRQoL, the adjusted mean differences were 0.04 (95% CI - 0.03 to 0.11; P = 0.091) for EQ-5D-5L-5L index values, and 3.3 (95% CI - 9.3 to 17.5; P = 0.142) for EQ VAS. CONCLUSIONS: In acutely admitted adult ICU patients with delirium, haloperidol treatment reduced mortality at 1-year follow-up, but did not statistically significantly improve HRQoL.

Healthcare professionals' experiences during the initial stage of the COVID-19 pandemic in the intensive care unit: A qualitative study.

BACKGROUND: The COVID-19 pandemic called for rapidly considerable changes in the healthcare system. Healthcare professionals from different departments within the hospital settings were enrolled in the emergency preparedness. This study, therefore, aimed to explore the healthcare professionals' experiences attending the ICU-preparedness and caring for patients with COVID-19 during the initial stage of the pandemic. METHODS: A descriptive explorative qualitative study was conducted by interviewing healthcare professionals during spring 2020, exploring their experiences as part of the ICU-preparedness team and caring for patients with COVID-19 in the ICU. Healthcare professionals from different departments were recruited by purposive sampling. The interviews were transcribed verbatim and analysed using content analysis. FINDINGS: Sixteen nurses and four physicians from a university hospital in Denmark participated. The analysis revealed three main themes and eight sub-themes. The main themes were (1) Professionalism in work-life (adaption, the patient's welfare, insecurity, and security), (2) Community Spirit (responsibility and contribution), and (3) Institutional organisation (the role of management, loss of freedom, and information). INTERPRETATION: Despite work specialities and professions, the participants reported a uniformity of similar experiences of uncertainties, but also a sense of community arose during the first phase of COVID-19. RECOMMENDATIONS: To ensure resilience and mental health, and well-being for the healthcare professionals, comprehensive support should be provided. Guidelines for interventions and training are necessary to promote preparedness and reduce psychological stress.

Delirium in Intensive Care.

Purpose of Review: Delirium in the intensive care unit (ICU) has become increasingly acknowledged as a significant problem for critically ill patients affecting both the actual course of illness as well as outcomes. In this review, we focus on the current evidence and the gaps in knowledge. Recent Findings: This review highlights several areas in which the evidence is weak and further research is needed in both pharmacological and non-pharmacological treatment. A better understanding of subtypes and their different response to therapy is needed and further studies in aetiology are warranted. Larger studies are needed to explore risk factors for developing delirium and for examining long-term consequences. Finally, a stronger focus on experienced delirium and considering the perspectives of both patients and their families is encouraged. Summary: With the growing number of studies and a better framework for research leading to stronger evidence, the outcomes for patients suffering from delirium will most definitely improve in the years to come.

Caring for non-sedated mechanically ventilated patients in ICU: A qualitative study comparing perspectives of expert and competent nurses.

BACKGROUND: Sedation practice has evolved from deep to lighter or no sedation in mechanically ventilated patients in the intensive care unit (ICU). The care of conscious intubated patients constitutes a change in the nurse-patient interaction. OBJECTIVE: We aimed to compare the perspectives of expert and competent nurses regarding their interaction with non-sedated mechanically ventilated ICU patients. METHOD: The study had a qualitative comparative design applying semi-structured dyadic interviews. We interviewed five pairs of expert and competent ICU nurses with respectively >8 and 2-3 years of ICU experience and performed qualitative content analysis to explore the two perspectives. FINDINGS: We identified four main categories illustrating complexities of nurse-patient interaction: Managing frustration, Attempting dialogue, Negotiating reality and Alleviating discomfort. Expert nurses expressed more frustration and ambivalence towards light sedation than competent nurses, who took awake patients for granted. All nurses experienced communication issues, demanding patients, and inability to provide adequate patient comfort. CONCLUSION: Our study added to the knowledge of nurse-patient interaction by describing issues of frustration, ambivalence and insecurity in a contemporary context of minimal sedation. Expert nurses were mere concerned by awake patients than competent nurses. Lighter sedation in ICU requires better staffing and improved communication tools.