Prediction of Long-Term Physical, Mental, and Cognitive Problems Following Critical Illness: Development and External Validation of the PROSPECT Prediction Model.

OBJECTIVES: ICU survivors often suffer from long-lasting physical, mental, and cognitive health problems after hospital discharge. As several interventions that treat or prevent these problems already start during ICU stay, patients at high risk should be identified early. This study aimed to develop a model for early prediction of post-ICU health problems within 48 hours after ICU admission. DESIGN: Prospective cohort study in seven Dutch ICUs. SETTING/PATIENTS: ICU patients older than 16 years and admitted for greater than or equal to 12 hours between July 2016 and March 2020. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Outcomes were physical problems (fatigue or ≥ 3 new physical symptoms), mental problems (anxiety, depression, or post-traumatic stress disorder), and cognitive impairment. Patient record data and questionnaire data were collected at ICU admission, and after 3 and 12 months, of 2,476 patients. Several models predicting physical, mental, or cognitive problems and a composite score at 3 and 12 months were developed using variables collected within 48 hours after ICU admission. Based on performance and clinical feasibility, a model, PROSPECT, predicting post-ICU health problems at 3 months was chosen, including the predictors of chronic obstructive pulmonary disease, admission type, expected length of ICU stay greater than or equal to 2 days, and preadmission anxiety and fatigue. Internal validation using bootstrapping on data of the largest hospital ( n = 1,244) yielded a C -statistic of 0.73 (95% CI, 0.70-0.76). External validation was performed on data ( n = 864) from the other six hospitals with a C -statistic of 0.77 (95% CI, 0.73-0.80). CONCLUSIONS: The developed and externally validated PROSPECT model can be used within 48 hours after ICU admission for identifying patients with an increased risk of post-ICU problems 3 months after ICU admission. Timely preventive interventions starting during ICU admission and follow-up care can prevent or mitigate post-ICU problems in these high-risk patients.

Development of Moral Injury in ICU Professionals During the COVID-19 Pandemic: A Prospective Serial Interview Study.

OBJECTIVES: During the COVID-19 pandemic, ICU professionals have faced moral problems that may cause moral injury. This study explored whether, how, and when moral injury among ICU professionals developed in the course of the COVID-19 pandemic. DESIGN: This is a prospective qualitative serial interview study. SETTING: Two hospitals among which one university medical center and one teaching hospital in the Netherlands. SUBJECTS: Twenty-six ICU professionals who worked during the COVID-19 pandemic. INTERVENTIONS: None. MEASUREMENTS MAIN RESULTS: In-depth interviews with follow-up after 6 and 12 months. In total, 62 interviews were conducted. ICU professionals narrated about anticipatory worry about life and death decisions, lack of knowledge and prognostic uncertainty about COVID-19, powerlessness and failure, abandonment or betrayal by society, politics, or the healthcare organization, numbness toward patients and families, and disorientation and self-alienation. Centrally, ICU professionals describe longitudinal processes by which they gradually numbed themselves emotionally from patients and families as well as potentially impactful events in their work. For some ICU professionals, organizational, societal, and political responses to the pandemic contributed to numbness, loss of motivation, and self-alienation. CONCLUSIONS: ICU professionals exhibit symptoms of moral injury such as feelings of betrayal, detachment, self-alienation, and disorientation. Healthcare organizations and ICU professionals themselves should be cognizant that these feelings may indicate that professionals might have developed moral injury or that it may yet develop in the future. Awareness should be raised about moral injury and should be followed up by asking morally injured professionals what they need, so as to not risk offering unwanted help.

Effect of Structural Moral Case Deliberation on Burnout Symptoms, Moral Distress, and Team Climate in ICU Professionals: A Parallel Cluster Randomized Trial.

OBJECTIVES: Moral case deliberation (MCD) is a team-based and facilitator-led, structured moral dialogue about ethical difficulties encountered in practice. This study assessed whether offering structural MCD in ICUs reduces burnout symptoms and moral distress and strengthens the team climate among ICU professionals. DESIGN: This is a parallel cluster randomized trial. SETTING: Six ICUs in two hospitals located in Nijmegen, between January 2020 and September 2021. SUBJECTS: Four hundred thirty-five ICU professionals. INTERVENTIONS: Three of the ICUs organized structural MCD. In three other units, there was no structural MCD or other structural discussions of moral problems. MEASUREMENTS AND MAIN RESULTS: The primary outcomes investigated were the three burnout symptoms-emotional exhaustion, depersonalization, and a low sense of personal accomplishment-among ICU professionals measured using the Maslach Burnout Inventory on a 0-6 scale. Secondary outcomes were moral distress (Moral Distress Scale) on a 0-336 scale and team climate (Safety Attitude Questionnaire) on a 0-4 scale. Organizational culture was an explorative outcome (culture of care barometer) and was measured on a 0-4 scale. Outcomes were measured at baseline and in 6-, 12-, and 21-month follow-ups. Intention-to-treat analyses were conducted using linear mixed models for longitudinal nested data. Structural MCD did not affect emotional exhaustion or depersonalization, or the team climate. It reduced professionals' personal accomplishment (-0.15; p < 0.05) but also reduced moral distress (-5.48; p < 0.01). Perceptions of organizational support (0.15; p < 0.01), leadership (0.19; p < 0.001), and participation opportunities (0.13; p < 0.05) improved. CONCLUSIONS: Although structural MCD did not mitigate emotional exhaustion or depersonalization, and reduced personal accomplishment in ICU professionals, it did reduce moral distress. Moreover, it did not improve team climate, but improved the organizational culture.

Development and External Validation of a Prediction Model for Quality of Life of ICU Survivors: A Subanalysis of the MONITOR-IC Prospective Cohort Study.

OBJECTIVES: To develop and externally validate a prediction model for ICU survivors' change in quality of life 1 year after ICU admission that can support ICU physicians in preparing patients for life after ICU and managing their expectations. DESIGN: Data from a prospective multicenter cohort study (MONITOR-IC) were used. SETTING: Seven hospitals in the Netherlands. PATIENTS: ICU survivors greater than or equal to 16 years old. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Outcome was defined as change in quality of life, measured using the EuroQol 5D questionnaire. The developed model was based on data from an academic hospital, using multivariable linear regression analysis. To assist usability, variables were selected using the least absolute shrinkage and selection operator method. External validation was executed using data of six nonacademic hospitals. Of 1,804 patients included in analysis, 1,057 patients (58.6%) were admitted to the academic hospital, and 747 patients (41.4%) were admitted to a nonacademic hospital. Forty-nine variables were entered into a linear regression model, resulting in an explained variance ( R2 ) of 56.6%. Only three variables, baseline quality of life, admission type, and Glasgow Coma Scale, were selected for the final model ( R2 = 52.5%). External validation showed good predictive power ( R2 = 53.2%). CONCLUSIONS: This study developed and externally validated a prediction model for change in quality of life 1 year after ICU admission. Due to the small number of predictors, the model is appealing for use in clinical practice, where it can be implemented to prepare patients for life after ICU. The next step is to evaluate the impact of this prediction model on outcomes and experiences of patients.

Adverse Events in Pediatric Critical Care Nonsurvivors With a Low Predicted Mortality Risk: A Multicenter Case Control Study.

OBJECTIVES: Some patients with a low predicted mortality risk in the PICU die. The contribution of adverse events to mortality in this group is unknown. The aim of this study was to estimate the occurrence of adverse events in low-risk nonsurvivors (LN), compared with low-risk survivors (LS) and high-risk PICU survivors and nonsurvivors, and the contribution of adverse events to mortality. DESIGN: Case control study. Admissions were selected from the national Dutch PICU registry, containing 53,789 PICU admissions between 2006 and 2017, in seven PICUs. PICU admissions were stratified into four groups, based on mortality risk (low/high) and outcome (death/survival). Random samples were selected from the four groups. Cases were "LN." Control groups were as follows: "LS," "high-risk nonsurvivors" (HN), and "high-risk survivors" (HS). Adverse events were identified using the validated trigger tool method. SETTING: Patient chart review study. PATIENTS: Children admitted to the PICU with either a low predicted mortality risk (< 1%) or high predicted mortality risk (≥ 30%). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: In total, 419 patients were included (102 LN, 107 LS, 104 HN, and 106 HS). LN had more complex chronic conditions (93.1%) than LS (72.9%; p < 0.01), HN (49.0%; p < 0.001), and HS (48.1%; p < 0.001). The occurrence of adverse events in LN (76.5%) was higher than in LS (13.1%) and HN (47.1%) ( p < 0.001). The most frequent adverse events in LN were hospital-acquired infections and drug/fluid-related adverse events. LN suffered from more severe adverse events compared with LS and HS ( p < 0.001). In 30.4% of LN, an adverse event contributed to death. In 8.8%, this adverse event was considered preventable. CONCLUSIONS: Significant and preventable adverse events were found in low-risk PICU nonsurvivors. 76.5% of LN had one or more adverse events. In 30.4% of LN, an adverse event contributed to mortality.

Optimizing an existing prediction model for quality of life one-year post-intensive care unit: An exploratory analysis.

BACKGROUND: This study aimed to improve the PREPARE model, an existing linear regression prediction model for long-term quality of life (QoL) of intensive care unit (ICU) survivors by incorporating additional ICU data from patients' electronic health record (EHR) and bedside monitors. METHODS: The 1308 adult ICU patients, aged ≥16, admitted between July 2016 and January 2019 were included. Several regression-based machine learning models were fitted on a combination of patient-reported data and expert-selected EHR variables and bedside monitor data to predict change in QoL 1 year after ICU admission. Predictive performance was compared to a five-feature linear regression prediction model using only 24-hour data (R2  = 0.54, mean square error (MSE) = 0.031, mean absolute error (MAE) = 0.128). RESULTS: The 67.9% of the included ICU survivors was male and the median age was 65.0 [IQR: 57.0-71.0]. Median length of stay (LOS) was 1 day [IQR 1.0-2.0]. The incorporation of the additional data pertaining to the entire ICU stay did not improve the predictive performance of the original linear regression model. The best performing machine learning model used seven features (R2  = 0.52, MSE = 0.032, MAE = 0.125). Pre-ICU QoL, the presence of a cerebro vascular accident (CVA) upon admission and the highest temperature measured during the ICU stay were the most important contributors to predictive performance. Pre-ICU QoL's contribution to predictive performance far exceeded that of the other predictors. CONCLUSION: Pre-ICU QoL was by far the most important predictor for change in QoL 1 year after ICU admission. The incorporation of the numerous additional features pertaining to the entire ICU stay did not improve predictive performance although the patients' LOS was relatively short.

Morisprudence: a theoretical framework for studying the relationship linking moral case deliberation, organisational learning and quality improvement.

There is a claim that clinical ethics support services (CESS) improve healthcare quality within healthcare organisations. However, there is lack of strong evidence supporting this claim. Rather, the current focus is on the quality of CESS themselves or on individual learning outcomes. In response, this article proposes a theoretical framework leading to empirical hypotheses that describe the relationship between a specific type of CESS, moral case deliberation and the quality of care at the organisational level. We combine insights from the literature on CESS, organisational learning and quality improvement and argue that moral case deliberation causes healthcare professionals to acquire practical wisdom. At the organisational level, where improving quality is a continuous and collective endeavour, this practical wisdom can be aggregated into morisprudence, which is an ongoing formulation of moral judgements across cases encountered within the organisation. Focusing on the development of morisprudence enables refined scrutinisation of CESS-related quality claims.

New Physical, Mental, and Cognitive Problems 1 Year after ICU Admission: A Prospective Multicenter Study.

Rationale: Comprehensive studies addressing the incidence of physical, mental, and cognitive problems after ICU admission are lacking. With an increasing number of ICU survivors, an improved understanding of post-ICU problems is necessary. Objectives: To determine the occurrence and cooccurrence of new physical, mental, and cognitive problems among ICU survivors 1 year after ICU admission, their impact on daily functioning, and risk factors associated with 1-year outcomes. Methods: Prospective multicenter cohort study, including ICU patients ⩾16 years of age, admitted for ⩾12 hours between July 2016 and June 2019. Patients, or proxies, rated their health status before and 1 year after ICU admission using questionnaires. Measurements and Main Results: Validated questionnaires were used to measure frailty, fatigue, new physical symptoms, anxiety and depression, post-traumatic stress disorder, cognitive impairment, and quality of life. Of the 4,793 patients included, 2,345 completed the questionnaires both before and 1 year after ICU admission. New physical, mental, and/or cognitive problems 1 year after ICU admission were experienced by 58% of the medical patients, 64% of the urgent surgical patients, and 43% of the elective surgical patients. Urgent surgical patients experienced a significant deterioration in their physical and mental functioning, whereas elective surgical patients experienced a significant improvement. Medical patients experienced an increase in symptoms of depression. A significant decline in cognitive functioning was experienced by all types of patients. Pre-ICU health status was strongly associated with post-ICU health problems. Conclusions: Overall, 50% of ICU survivors suffer from new physical, mental, and/or cognitive problems. An improved insight into the specific health problems of ICU survivors would enable more personalized post-ICU care.

The Impact of Nursing Delirium Preventive Interventions in the ICU: A Multicenter Cluster-randomized Controlled Clinical Trial.

Rationale: Delirium is common in critically ill patients and is associated with deleterious outcomes. Nonpharmacological interventions are recommended in current delirium guidelines, but their effects have not been unequivocally established. Objectives: To determine the effects of a multicomponent nursing intervention program on delirium in the ICU. Methods: A stepped-wedge cluster-randomized controlled trial was conducted in ICUs of 10 centers. Adult critically ill surgical, medical, or trauma patients at high risk of developing delirium were included. A multicomponent nursing intervention program focusing on modifiable risk factors was implemented as standard of care. The primary outcome was the number of delirium-free and coma-free days alive in 28 days after ICU admission. Measurements and Main Results: A total of 1,749 patients were included. Time spent on interventions per 8-hour shift was median (interquartile range) 38 (14-116) minutes in the intervention period and median 32 (13-73) minutes in the control period (P = 0.44). Patients in the intervention period had a median of 23 (4-27) delirium-free and coma-free days alive compared with a median of 23 (5-27) days for patients in the control group (mean difference, -1.21 days; 95% confidence interval, -2.84 to 0.42 d; P = 0.15). In addition, the number of delirium days was similar: median 2 (1-4) days (ratio of medians, 0.90; 95% confidence interval, 0.75 to 1.09; P = 0.27). Conclusions: In this large randomized controlled trial in adult ICU patients, a limited increase in the use of nursing interventions was achieved, and no change in the number of delirium-free and coma-free days alive in 28 days could be determined. Clinical trial registered with www.clinicaltrials.gov (NCT03002701).

Putting measurement on a diet: development of a core set of indicators for quality improvement in the ICU using a Delphi method.

BACKGROUND: The number and efficacy of indicators used to monitor and improve the quality of care in Intensive Care Units (ICU) is debatable. This study aimed to select a consensus-based core set of indicators for effective quality improvement in the ICU. METHODS: A Delphi study with a panel of intensivists, ICU nurses, and former ICU patients or relatives (n = 34) from general, teaching, and academic hospitals. Panelists completed a questionnaire in which they scored 69 preselected quality indicators on relevance using a nine-point Likert scale. Indicators were categorized using the rated relevance score into: 'accepted, 'equivocal' and 'excluded'. Questionnaire results were discussed in focus groups to reach consensus on the final set. RESULTS: Response rates for the questionnaire and focus groups were 100 and 68%, respectively. Consensus was reached on a final set of 17 quality indicators including patient reported outcome measures (PROMs) and patient reported experience measures (PREMs). Other quality indicators relate to the organization and outcome of ICU care, including safety culture, ICU standardized mortality ratio, and the process indicator 'learning from and improving after serious incidents'. CONCLUSIONS: ICU clinicians and former patients and relatives developed a consensus-based core set of ICU quality indicators that is relatively short but comprehensive and particularly tailored to end-users needs.

Clinical Outcomes Among Patients With 1-Year Survival Following Intensive Care Unit Treatment for COVID-19.

IMPORTANCE: One-year outcomes in patients who have had COVID-19 and who received treatment in the intensive care unit (ICU) are unknown. OBJECTIVE: To assess the occurrence of physical, mental, and cognitive symptoms among patients with COVID-19 at 1 year after ICU treatment. DESIGN, SETTING, AND PARTICIPANTS: An exploratory prospective multicenter cohort study conducted in ICUs of 11 Dutch hospitals. Patients (N = 452) with COVID-19, aged 16 years and older, and alive after hospital discharge following admission to 1 of the 11 ICUs during the first COVID-19 surge (March 1, 2020, until July 1, 2020) were eligible for inclusion. Patients were followed up for 1 year, and the date of final follow-up was June 16, 2021. EXPOSURES: Patients with COVID-19 who received ICU treatment and survived 1 year after ICU admission. MAIN OUTCOMES AND MEASURES: The main outcomes were self-reported occurrence of physical symptoms (frailty [Clinical Frailty Scale score ≥5], fatigue [Checklist Individual Strength-fatigue subscale score ≥27], physical problems), mental symptoms (anxiety [Hospital Anxiety and Depression {HADS} subscale score ≥8], depression [HADS subscale score ≥8], posttraumatic stress disorder [mean Impact of Event Scale score ≥1.75]), and cognitive symptoms (Cognitive Failure Questionnaire-14 score ≥43) 1 year after ICU treatment and measured with validated questionnaires. RESULTS: Of the 452 eligible patients, 301 (66.8%) patients could be included, and 246 (81.5%) patients (mean [SD] age, 61.2 [9.3] years; 176 men [71.5%]; median ICU stay, 18 days [IQR, 11 to 32]) completed the 1-year follow-up questionnaires. At 1 year after ICU treatment for COVID-19, physical symptoms were reported by 182 of 245 patients (74.3% [95% CI, 68.3% to 79.6%]), mental symptoms were reported by 64 of 244 patients (26.2% [95% CI, 20.8% to 32.2%]), and cognitive symptoms were reported by 39 of 241 patients (16.2% [95% CI, 11.8% to 21.5%]). The most frequently reported new physical problems were weakened condition (95/244 patients [38.9%]), joint stiffness (64/243 patients [26.3%]) joint pain (62/243 patients [25.5%]), muscle weakness (60/242 patients [24.8%]) and myalgia (52/244 patients [21.3%]). CONCLUSIONS AND RELEVANCE: In this exploratory study of patients in 11 Dutch hospitals who survived 1 year following ICU treatment for COVID-19, physical, mental, or cognitive symptoms were frequently reported.

Coronavirus Disease 2019 Immediately Increases Burnout Symptoms in ICU Professionals: A Longitudinal Cohort Study.

OBJECTIVES: ICU professionals are at risk of developing burnout due to coronavirus disease 2019. This study assesses the prevalence and incidence of burnout symptoms and moral distress in ICU professionals before and during the coronavirus disease 2019 crisis. DESIGN: This is a longitudinal open cohort study. SETTING: Five ICUs based in a single university medical center plus another adult ICU based on a separate teaching hospital in the Netherlands. SUBJECTS: All ICU professionals were sent a baseline survey in October-December 2019 (252 respondents, response rate: 53%), and a follow-up survey was sent in May-June 2020 (233 respondents, response rate: 50%). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Burnout symptoms and moral distress measured with the Maslach Burnout Inventory and the Moral Distress Scale, respectively. The prevalence of burnout symptoms was 23.0% before coronavirus disease 2019 and 36.1% at postpeak time, with higher rates in nurses (38.0%) than in physicians (28.6%). Reversely, the incidence rate of new burnout cases among physicians was higher (26.7%) than nurses (21.9%). Higher prevalence of burnout symptoms was observed in the postpeak coronavirus disease 2019 period (odds ratio, 1.83; 95% CI, 1.32-2.53), for nurses (odds ratio, 1.77; 95% CI, 1.03-3.04), for professionals working overtime (odds ratio 2.11; 95% CI, 1.48-3.02), and for professionals directly engaged with care for coronavirus disease 2019 patients (odds ratio, 1.87; 95% CI, 1.35-2.60). Physicians were more likely than nurses to develop burnout symptoms due to coronavirus disease 2019 (odds ratio, 3.56; 95% CI, 1.06-12.21). CONCLUSIONS: This study shows that overburdening of ICU professionals during an extended period of time leads to symptoms of burnout. Working long hours and under conditions of scarcity of staff, time, and resources comes at the price of ICU professionals' mental health.

Physical, Mental, and Cognitive Health Status of ICU Survivors Before ICU Admission: A Cohort Study.

OBJECTIVES: Although patient's health status before ICU admission is the most important predictor for long-term outcomes, it is often not taken into account, potentially overestimating the attributable effects of critical illness. Studies that did assess the pre-ICU health status often included specific patient groups or assessed one specific health domain. Our aim was to explore patient's physical, mental, and cognitive functioning, as well as their quality of life before ICU admission. DESIGN: Baseline data were used from the longitudinal prospective MONITOR-IC cohort study. SETTING: ICUs of four Dutch hospitals. PATIENTS: Adult ICU survivors (n = 2,467) admitted between July 2016 and December 2018. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patients, or their proxy, rated their level of frailty (Clinical Frailty Scale), fatigue (Checklist Individual Strength-8), anxiety and depression (Hospital Anxiety and Depression Scale), cognitive functioning (Cognitive Failure Questionnaire-14), and quality of life (Short Form-36) before ICU admission. Unplanned patients rated their pre-ICU health status retrospectively after ICU admission. Before ICU admission, 13% of all patients was frail, 65% suffered from fatigue, 28% and 26% from symptoms of anxiety and depression, respectively, and 6% from cognitive problems. Unplanned patients were significantly more frail and depressed. Patients with a poor pre-ICU health status were more often likely to be female, older, lower educated, divorced or widowed, living in a healthcare facility, and suffering from a chronic condition. CONCLUSIONS: In an era with increasing attention for health problems after ICU admission, the results of this study indicate that a part of the ICU survivors already experience serious impairments in their physical, mental, and cognitive functioning before ICU admission. Substantial differences were seen between patient subgroups. These findings underline the importance of accounting for pre-ICU health status when studying long-term outcomes.

Nonpharmacologic Interventions to Prevent or Mitigate Adverse Long-Term Outcomes Among ICU Survivors: A Systematic Review and Meta-Analysis.

OBJECTIVE: ICU survivors suffer from long-lasting physical, mental, and cognitive health impairments, also called "postintensive care syndrome". However, an overview of the effectiveness of interventions to prevent or mitigate these impairments is lacking. The aim of this study is to assess the effectiveness of nonpharmacologic interventions. DATA SOURCES: PubMed, CINAHL, PsycINFO, Embase, and Cochrane Library were systematically searched from inception until July 19, 2018. STUDY SELECTION: (Non)randomized clinical trials, controlled before-after studies, and interrupted time series were included. Outcomes of interest included patients physical, mental and cognitive outcomes, quality of life, and outcomes such as social functioning and functional status, measured after hospital discharge. DATA EXTRACTION: Two independent reviewers selected studies, extracted data, and assessed the risk of bias. Pooled mean differences and standardized mean differences were calculated using random-effect meta-analyses. DATA SYNTHESIS: After screening 17,008 articles, 36 studies, including 10 pilot studies, were included (n = 5,165 ICU patients). Interventions were subdivided into six categories: 1) exercise and physical rehabilitation programs; 2) follow-up services; 3) psychosocial programs; 4) diaries; 5) information and education; and 6) other interventions. Many outcomes favored the interventions, but significant differences were only found for diaries in reducing depression (two studies, n = 88; standardized mean difference, 0.68; 95% CI, 0.14-1.21) and anxiety (two studies, n = 88; standardized mean difference, 0.44; 95% CI, 0.01-0.87) and exercise programs in improving the Short Form Health Survey-36 Mental Component Score (seven studies, n = 664; mean difference, 2.62; 95% CI, 0.92-4.32). CONCLUSIONS: There is thin evidence that diaries and exercise programs have a positive effective on mental outcomes. Despite outcomes favoring the intervention group, other commonly used nonpharmacologic interventions in daily ICU practice are not supported by conclusive evidence from this meta-analysis. To improve recovery programs for ICU survivors, more evidence is needed from robust intervention studies using standardized outcomes.

Prophylactic Haloperidol Effects on Long-term Quality of Life in Critically Ill Patients at High Risk for Delirium: Results of the REDUCE Study.

BACKGROUND: Delirium incidence in intensive care unit patients is high and associated with impaired long-term outcomes. The use of prophylactic haloperidol did not improve short-term outcome among critically ill adults at high risk of delirium. This study evaluated the effects of prophylactic haloperidol use on long-term quality of life in this group of patients and explored which factors are associated with change in quality of life. METHODS: A preplanned secondary analysis of long-term outcomes of the pRophylactic haloperidol usE for DeliriUm in iCu patients at high risk for dElirium (REDUCE) study was conducted. In this multicenter randomized clinical trial, nondelirious intensive care unit patients were assigned to prophylactic haloperidol (1 or 2 mg) or placebo (0.9% sodium chloride). In all groups, patients finally received study medication for median duration of 3 days [interquartile range, 2 to 6] until onset of delirium or until intensive care unit discharge. Long-term outcomes were assessed using the Short Form-12 questionnaire at intensive care unit admission (baseline) and after 1 and 6 months. Quality of life was summarized in the physical component summary and mental component summary scores. Differences between the haloperidol and placebo group and factors associated with changes in quality of life were analyzed. RESULTS: Of 1,789 study patients, 1,245 intensive care unit patients were approached, of which 887 (71%) responded. Long-term quality of life did not differ between the haloperidol and placebo group (physical component summary mean score of 39 ± 11 and 39 ± 11, respectively, and P = 0.350; and mental component summary score of 50 ± 10 and 51 ± 10, respectively, and P = 0.678). Age, medical and trauma admission, quality of life score at baseline, risk for delirium (PRE-DELIRIC) score, and the number of sedation-induced coma days were significantly associated with a decline in long-term quality of life. CONCLUSIONS: Prophylactic haloperidol use does not affect long-term quality of life in critically ill patients at high risk for delirium. Several factors, including the modifiable factor number of sedation-induced coma days, are associated with decline in long-term outcomes.

Effects of patient safety auditing in hospital care: results of a mixed-method evaluation (part 1).

OBJECTIVE: To evaluate the effectiveness of internal auditing in hospital care focussed on improving patient safety. DESIGN, SETTING AND PARTICIPANTS: A before-and-after mixed-method evaluation study was carried out in eight departments of a university medical center in the Netherlands. INTERVENTION(S): Internal auditing and feedback focussed on improving patient safety. MAIN OUTCOME MEASURE(S): The effect of internal auditing was assessed 15 months after the audit, using linear mixed models, on the patient, professional, team and departmental levels. The measurement methods were patient record review on adverse events (AEs), surveys regarding patient experiences, safety culture and team climate, analysis of administrative hospital data (standardized mortality rate, SMR) and safety walk rounds (SWRs) to observe frontline care processes on safety. RESULTS: The AE rate decreased from 36.1% to 31.3% and the preventable AE rate from 5.5% to 3.6%; however, the differences before and after auditing were not statistically significant. The patient-reported experience measures regarding patient safety improved slightly over time (P < 0.001). The SMR, patient safety culture and team climate remained unchanged after the internal audit. The SWRs showed that medication safety and information security were improved (P < 0.05). CONCLUSIONS: Internal auditing was associated with improved patient experiences and observed safety on wards. No effects were found on adverse outcomes, safety culture and team climate 15 months after the internal audit.

Process evaluation of the effects of patient safety auditing in hospital care (part 2).

OBJECTIVE: To identify factors that explain the observed effects of internal auditing on improving patient safety. DESIGN SETTING AND PARTICIPANTS: A process evaluation study within eight departments of a university medical centre in the Netherlands. INTERVENTION(S): Internal auditing and feedback for improving patient safety in hospital care. MAIN OUTCOME MEASURE(S): Experiences with patient safety auditing, percentage implemented improvement actions tailored to the audit results and perceived factors that hindered or facilitated the implementation of improvement actions. RESULTS: The respondents had positive audit experiences, with the exception of the amount of preparatory work by departments. Fifteen months after the audit visit, 21% of the intended improvement actions based on the audit results were completely implemented. Factors that hindered implementation were short implementation time: 9 months (range 5-11 months) instead of the 15 months' planned implementation time; time-consuming and labour-intensive implementation of improvement actions; and limited organizational support for quality improvement (e.g. insufficient staff capacity and time, no available quality improvement data and information and communication technological (ICT) support). CONCLUSIONS: A well-constructed analysis and feedback of patient safety problems is insufficient to reduce the occurrence of poor patient safety outcomes. Without focus and support in the implementation of audit-based improvement actions, quality improvement by patient safety auditing will remain limited.

The occurrence of adverse events in low-risk non-survivors in pediatric intensive care patients: an exploratory study.

We studied the occurrence of adverse events (AEs) in low-risk non-survivors (LNs), compared to low-risk survivors (LSs), high-risk non-survivors (HNs), and high-risk survivors (HSs) in two pediatric intensive care units (PICUs). The study was performed as a retrospective patient record review study, using a PICU-trigger tool. A random sample of 48 PICU patients (0-18 years) was chosen, stratified into four subgroups of 12 patients: LNs, LSs, HNs, and HSs. Primary outcome was the occurrence of AEs. The severity, preventability, and nature of the indentified AEs were determined. In total, 45 AEs were found in 20 patients. The occurrence of AEs in the LN group was significantly higher compared to that in the LS group and HN group (AE occurrence: LN 10/12 patients, LS 1/12 patients; HN 2/12 patients; HS 7/12 patients; LN-LS difference, p < 0.001; LN-HN difference, p < 0.01). The AE rate in the LN group was significantly higher compared to that in the LS and HN groups (median [IQR]: LN 0.12 [0.07-0.29], LS 0 [0-0], HN 0 [0-0], and HS 0.03 [0.0-0.17] AE/PICU day; LN-LS difference, p < 0.001; LN-HN difference, p < 0.01). The distribution of the AEs among the four groups was as follows: 25 AEs (LN), 2 AEs (LS), 8 AEs (HN), and 10 AEs (HS). Fifteen of forty-five AEs were preventable. In 2/12 LN patients, death occurred after a preventable AE. CONCLUSION: The occurrence of AEs in LNs was higher compared to that in LSs and HNs. Some AEs were severe and preventable and contributed to mortality. What is Known: • 59-76% of all PICU patients encounter at least one adverse event during their PICU stay. • It is unknown if adverse events play a role in death of low-risk PICU patients. What is New: • In low-risk PICU non-survivors, occurrence of adverse events is higher compared to low-risk PICU survivors and to high-risk PICU non-survivors. • Severe and preventable adverse events occur in low-risk PICU non-survivors, some contributing to mortality.