Assessment of patients' self-perceived intensive care unit discomforts: Validation of the 18-item version of the IPREA.

BACKGROUND AND AIMS: We reported the validation of the 18-item version of the 'Inconforts des Patients de REAnimation (IPREA)' questionnaire that includes 2 new items exploring feeling depressed and shortness of breath during an intensive care unit (ICU) stay. METHODS: The validation process was integrated in a multicenter, cluster-randomized, controlled, two-parallel group study built to assess the effectiveness of a tailored multicomponent program for reducing self-perceived discomfort in the ICU. All patients aged 18 years or older who survived an ICU stay of 3 calendar days or more were eligible for inclusion. Data collection included demographics (sex, age), type of admission (medical and surgical), health status scores at admission (Knaus score and McCabe index, Simplified Acute Physiology Score (SAPS) II), specific ICU therapeutics such as mechanical ventilation (MV), noninvasive ventilation (NIV), use of vasopressors, or renal replacement therapy (RRT), and ICU stay duration. RESULTS: A total of 994 patients were included. The initial structure of IPREA was confirmed using confirmatory factor analysis showing satisfactory fit (RMSEA at 0.042, CFI at 0.912). No multidimensional structure was identified, allowing the calculation of an overall discomfort score. The three highest discomforts were sleep deprivation, thirst, and perfusion lines and other devices, and the 3 lowest discomforts were limited visiting hours, hunger, and isolation. The overall discomfort score of the 18-item version of IPREA did not differ between men and women. Higher age was significantly correlated with a lower overall discomfort score. While MV was not linked to self-reported discomfort, patients treated by NIV reported higher overall discomfort scores than patients not treated by NIV. CONCLUSION: The 18-item version of IPREA is easy to use and possesses satisfactory psychometric properties. The availability of a reliable and valid French questionnaire asking about patients' self-perceived ICU discomforts enables feedback from the health care team to be incorporated in a continuous quality health care improvement strategy. TRIAL REGISTRATION: clinicaltrial.gov NCT02442934 (registration date: May 18, 2015, retrospectively registered).

The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs.

BACKGROUND: Post-intensive care syndrome includes the multiple consequences of an intensive care unit (ICU) stay for patients and families. It has become a new challenge for intensivists. Prevention programs have been disappointing, except for ICU diaries, which report the patient's story in the ICU. However, the effectiveness of ICU diaries for patients and families is still controversial, as the interpretation of the results of previous studies was open to criticism hampering an expanded use of the diary. The primary objective of the study is to evaluate the post-traumatic stress syndrome in patients. The secondary objectives are to evaluate the post-traumatic stress syndrome in families, anxiety and depression symptoms in patients and families, and the recollected memories of patients. Endpoints will be evaluated 3 months after ICU discharge or death. METHODS: A prospective, multicenter, randomized, assessor-blind comparative study of the effect of an ICU diary on patients and families. We will compare two groups: one group with an ICU diary written by staff and family and given to the patient at ICU discharge or to the family in case of death, and a control group without any ICU diary. Each of the 35 participating centers will include 20 patients having at least one family member who will likely visit the patient during their ICU stay. Patients must be ventilated within 48 h after ICU admission and not have any previous chronic neurologic or acute condition responsible for cognitive impairments that would hamper their participation in a phone interview. Three months after ICU discharge or death of the patient, a psychologist will contact the patient and family by phone. Post-traumatic stress syndrome will be evaluated using the Impact of Events Scale-Revised questionnaire, anxiety and depression symptoms using the Hospital Anxiety and Depression Scale questionnaire, both in patients and families, and memory recollection using the ICU Memory Tool Questionnaire in patients. The content of a randomized sample of diaries of each center will be analyzed using a grid. An interview of the patients in the intervention arm will be conducted 6 months after ICU discharge to analyze in depth how they use the diary. DISCUSSION: This study will provide new insights on the impact of ICU diaries on post-traumatic stress disorders in patients and families after an ICU stay. TRIAL REGISTRATION: ClinicalTrial.gov, ID: NCT02519725 . Registered on 13 July 2015.

Population pharmacokinetics of micafungin in ICU patients with sepsis and mechanical ventilation.

OBJECTIVES: To identify the factors associated with the interindividual pharmacokinetic (PK) variability of micafungin and to evaluate the probability of reaching the previously determined PK/pharmacodynamic efficacy thresholds (AUC/MIC >5000 for non-parapsilosis Candida sp. and ≥285 for Candida parapsilosis) with the recommended 100 mg daily dose in ICU patients with sepsis and mechanical ventilation. METHODS: One hundred patients were included and 436 concentrations were available for PK analysis performed with NONMEM software. PTA was determined by Monte Carlo simulations. RESULTS: Micafungin obeyed a two-compartment model with first-order elimination from the central compartment. Mean parameter estimates (percentage interindividual variability) were 1.34 L/h (34%) for clearance (CL), 11.80 L (38%) and 7.68 L (39%) for central (Vc) and peripheral (Vp) distribution volumes, respectively, and 4.67 L/h (37%) for distribution clearance. CL, Vc and Vp increased by 14% when the albumin level was ≤25 g/L and CL decreased by 25% when SOFA score was ≥10. Body weight was related to CL, Vc and Vp by allometric models. PTA was ≥90% in Candida albicans and Candida glabrata infections, except when the MIC was ≥0.015 mg/L, and ranged between 0% and 40% for C. parapsilosis infections with MIC ≥0.5 mg/L. CONCLUSIONS: A possible increase in the dose should be evaluated for infections due to C. parapsilosis and for infections due to C. albicans and C. glabrata with MICs ≥0.015 mg/L.

Predicting whether the ICU can help older patients: score needed.

Because the need for intensive care exceeds its availability in several countries, intensivists must admit those patients most likely to benefit. Intensive care unit admissions of elderly patients will increase substantially in the near future. Decreased self sufficiency and quality of life are common after hospitalization in older patients and they may require discharge to a nursing home, although some patients feel that life in a nursing home would be worse than dying. We have much to learn about matching the use of life-supporting treatments to the health-related values of older patients. A specific outcome-prediction score for older patients would help improve quality of care.

Epidemiology and economic evaluation of severe sepsis in France: age, severity, infection site, and place of acquisition (community, hospital, or intensive care unit) as determinants of workload and cost.

PURPOSE: Severe sepsis is a leading cause of death in critically ill patients. We evaluated cost and workload according to infection site, place and time of acquisition, and severity. MATERIAL AND METHOD: We used a prospective 3-year database from 6 intensive care units (ICUs) including 1698 patients. RESULTS: Of the 1698 patients, 713 (42%) had severe sepsis at admission and 339 during the ICU stay (211 had both). Mortality was twice as high in patients with than those without ICU-acquired infection, independent of the presence of severe sepsis at admission. The mean (SD; median) cost of severe sepsis was 22 800 (21 400 ; 15 800 ). Among patients with severe sepsis at admission, workload and cost were higher for pneumonia, peritonitis, and multiple-site infections and for hospital-acquired (17,400 [14,700; 17,400]) vs community-acquired infection (12,600 [12,100 ; 8900 ]). Intensive care unit-acquired severe sepsis was associated with greater than 3-fold increases in workload and costs. By multiple linear regression, older age, emergency surgery, septic shock, Acute Physiological and Chronic Health Evaluation II score, and hospital or ICU-acquired severe sepsis were independently associated with higher costs. CONCLUSIONS: The wide variations in cost and workload invite efforts to identify patient subgroups most likely to benefit from high-cost treatments and from prevention, particularly targeting severe nosocomial infections.

Body mass index. An additional prognostic factor in ICU patients.

OBJECTIVE: To examine the association between body mass index (BMI) and mortality in adult intensive care unit (ICU) patients. DESIGN. A prospective multi-center study. INTERVENTIONS: None. METHODS: A cohort study (yielding the OUTCOMEREA database) was conducted over 2 years in 6 medical-surgical ICUs. In each participating ICU, the following were collected daily: demographic information, admission height and weight, comorbidities, severity scores (SAPS II, LOD, and SOFA), ICU and hospital lengths of stay, and ICU and hospital mortality rates. RESULTS: A total of 1,698 patients were examined and divided into 4 groups based on BMI: <18.5, 18.5-24.9, 25-29.9, and >30 kg/m(2). These groups differed significantly for age, gender, admission category (medical, scheduled surgery, unscheduled surgery), ICU and hospital lengths of stay, and comorbidities. Severity at admission and within the first 2 days was similar in the 4 groups, except for the SOFA score. Overall hospital mortality was 31.3% (532 out of 1,698 patients). By multivariate analysis, a BMI below 18.5 kg/m(2) was independently associated with increased mortality (odds ratio 1.63; 95% confidence intervals 1.11-2.39). None of the other BMI categories were associated with higher mortality and even a BMI>30 kg/m(2) was protective of mortality (odds ratio 0.60, 95% confidence intervals 0.40-0.88). CONCLUSIONS: A low BMI was independently associated with higher mortality and a high BMI with lower mortality in this large cohort of critically ill patients. Since BMI is absent from currently available scoring systems, further studies are needed to determine whether adding BMI would improve the effectiveness of scores in predicting mortality.

Calibration and discrimination by daily Logistic Organ Dysfunction scoring comparatively with daily Sequential Organ Failure Assessment scoring for predicting hospital mortality in critically ill patients.

OBJECTIVE: The Logistic Organ Dysfunction (LOD) score has been proved effective in evaluating severity during the first day in an intensive care unit but has not been evaluated later. To evaluate attributable mortality related to nosocomial events, organ dysfunction scores that remain accurate throughout the intensive care unit stay are needed. The objective of this study was to evaluate how accurately daily LOD scoring predicts mortality comparatively with daily Sequential Organ Failure Assessment (SOFA) scoring. DESIGN: Prospective multicenter study. SETTING: Six intensive care units in France. PATIENTS: A total of 1685 patients with intensive care unit stays longer than 48 hrs were included in this study (511 hospital deaths). Median age was 66 yrs, and median Simplified Acute Physiology Score II at admission was 38. For each patient, a senior physician recorded the variables needed to compute organ dysfunction scores daily throughout the intensive care unit stay. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: SOFA and LOD scores were computed daily during the first 7 days. Calibration was evaluated based on goodness-of-fit by the Hosmer-Lemeshow chi-square statistic (lower chi-square values and higher values indicate better fit) and discrimination based on the receiver operating characteristics (ROC) area under the curve (AUC; a ROC-AUC of 1 indicates faultless discrimination and a ROC-AUC of 0.5 indicates the effects of chance alone). Because calibration of both scores was poor at all time points ( p<.001), customization was performed using the total score (model 1) or separate introduction of each dysfunction (model 2). The performance of customized LOD and SOFA scores on a given day in predicting mortality was assessed in those patients who spent at least one more calendar day in the intensive care unit. The original LOD and SOFA scores had satisfactory ROC-AUC values (0.720 to 0.766). Internal consistency of both scores was acceptable ( p< 10(-4) for each organ dysfunction). After customization, the original scores calibrated well between days 1 and 7. Discrimination by both scores was better with model 2 (AUC-ROC, 0.729-0.784). CONCLUSION: Daily LOD and SOFA scores showed good accuracy and internal consistency, and they could be used to adjust severity for events occurring in the intensive care unit.