Informed consent for research in ICU obtained before ICU admission

Objective: To analyze the procedure of the informed consent for ICU research obtained before ICU admission. Design: Prospective, open, observational study. Setting: 20-bed surgical ICU of atertiary teaching university hospital and the ward before and after ICU. Patients: Patients, scheduled for elective cardiac surgery, who accepted to participate in acoagulation study. Interventions: Patients underwent the same informed consent procedure, including an oral presentation of the coagulation study and an informative leaflet the day before surgery on the ward. Measurements and results: Between January and August2001, we included 38patients; 36survived ICU. Ten to 12days after surgery, 8/36(22%) patients did not know they had participated in astudy, and 9/36(25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4(3-6) vs3(1-5)days; p = 0.004]. None of these patients (0/9 vs10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure. Conclusions: Even when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, asubstantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participatio

ICU research: the impact of invasiveness on informed consent

Purpose: Studies into the preferences of patients and relatives regarding informed consent for intensive care unit (ICU) research are ongoing. We investigated the impact of a study's invasiveness on the choice of who should give consent and on the modalities of informed consent. Methods: At ICU discharge, randomized pairs of patients and relatives were asked to answer a questionnaire about informed consent for research. One group received a vignette of a noninvasive study; the other, of an invasive study. Each study comprised two scenarios, featuring either a conscious or unconscious patient. Multivariate models assessed independent factors related to their preferences. Results: A total of 185 patients (40%) and 125 relatives (68%) responded. The invasiveness of a study had no impact on which people were chosen to give consent. This increased the desire to get more than one person to give consent and decreased the acceptance of deferred or two-step consent. Up to 31% of both patients and relatives chose people other than the patient himself to give consent, even when the patient was conscious. A range of 3 to 17% of the respondents reported that they would accept a waiving of consent. Younger respondents and individuals feeling coerced into study participation wanted to be the decision makers. Conclusions: Study invasiveness had no impact on patients' and relatives' preferences about who should give consent. Many patients and relatives were reluctant to give consent alone. Deferred and two-step consent were less acceptable for the invasive study. Further work should investigate whether sharing the burden of informed consent with a second person facilitates participation in ICU researc

Informed consent for research obtained during the intensive care unit stay

INTRODUCTION: Patients in the intensive care unit (ICU) may be in an inadequate condition to give their informed consent for research. The aim of this study was to analyse the ability to recall participation in a clinical trial for which ICU patients had given their consent. METHODS: The data presented are a two-step observational study: first, a protocolled informed consent procedure was conducted then the informed consent was given by the patient, and second, a patient interview was held 10 ± 2 days later by the same investigator. The primary endpoints were the ability to recall their participation in the clinical trial, as well as its purpose and related risks. As secondary endpoints, we investigated whether asking questions about the clinical trial or reading the informative leaflet was related to the recall. To be included in the study, the patient had to have a Glasgow Coma Scale score of 15, be fully oriented and free of mechanical ventilation, and be judged competent by both the investigator and the attending physician. Patients admitted to the ICU after major surgery or trauma were eligible. However, patients who refused to participate, or those whose next-of-kin gave consent, were excluded. RESULTS: Of the 44 patients, 35 (80%) recognized, 10 to 12 days after informed consent had been obtained, that they had participated in the clinical trial, but only 14 out of 44 (32%) could recall the clinical trial purpose and its related risks. More patients with complete recall had read the informative leaflet or asked at least one question before signing the informed consent. Asking at least one question was associated with complete recall. CONCLUSION: Our results confirm that obtaining informed consent for research during an ICU stay is associated with poor patient recall of participation in a clinical trial and its components (purpose and risk). Whether encouraging reading the informative leaflet and asking questions about the clinical trial improves the informed consent procedure remains to be fully investigated

Coercion in intensive care, an insufficiently explored issue—a scoping review of qualitative narratives of patient’s experiences

Purpose The use of coercion, in a clinical context as imposing a measure against a patient’s opposition or declared will, can occur in various forms in intensive care units (ICU). One prime example of a formal coercive measure in the ICU is the use of restraints, which are applied for patients’ own safety. Through a database search, we sought to evaluate patient experiences related to coercive measures. Results For this scoping review, clinical databases were searched for qualitative studies. A total of nine were identified that fulfilled the inclusion and the CASP criteria. Common themes emerging from the studies on patient experiences included communication issues, delirium, and emotional reactions. Statements from patients revealed feelings of compromised autonomy and dignity that came with a loss of control. Physical restraints were only one concrete manifestation of formal coercion as perceived by patients in the ICU setting. Conclusion There are few qualitative studies focusing on patient experiences of formal coercive measures in the ICU. In addition to the experience of restricted physical movement, the perception of loss of control, loss of dignity, and loss of autonomy suggests that restraining measures are just one element in a setting that may be perceived as informal coercion

What does coercion in intensive care mean for patients and their relatives? A thematic qualitative study

Background: The need for an ethical debate about the use of coercion in intensive care units (ICU) may not be as obvious as in other areas of medicine, such as psychiatry. Coercive measures are often necessary to treat critically ill patients in the ICU. It is nevertheless important to keep these measures to a minimum in order to respect the dignity of patients and the cohesion of the clinical team. A deeper understanding of what patients and their relatives perceive during their ICU stay will shed different light on intensive care management. Patients' experiences of loss of control, dependency and abandonment may lead to a new approach towards a broader approach to the concept of coercion in intensive care. The aim of our research is to explore the experiences of patients and relatives in the ICU and to determine when it might be possible to reduce feelings and memories of coercion. Methods: We conducted and analysed 29 semi-structured interviews with patients and relatives who had been in the ICU a few months previously. Following a coding and categorisation process in MAXQDA™, a rigorous qualitative methodology was used to identify themes relevant to our research. Results: Five main themes emerged: memory issues; interviewees' experiences of restricting measures and coercive treatment; patients' negative perception of situational and relational dependency with the risk of informal coercion; patients' perceptions of good care in a context of perceived dependency; progression from perception of coercion and dependency to respect for the person. All patients were grateful to have survived. However, coercion in the form of restraint, restriction of movement, and coercive treatment in the ICU was also acknowledged by patients and relatives. These included elements of informal coercion beyond restraints, such as a perceived negative sense of dependence, surrender, and asymmetrical interaction between the patient and health providers. Conclusions: To capture the full range of patients' experiences of coercion, it is necessary to expand the concept of coercion to include less obvious forms of informal coercion that may occur in dependency situations. This will help identify solutions to avoid or reduce negative recollections that may persist long after discharge and negatively affect the patients' quality of life. Keywords: Autonomy; Coercion; Ethics; Formal–informal; Intensive care unit; Patient experiences

Risk factors for reperfusion injury after lung transplantation

Objective: To assess the influence of recipient's and donor's factors as well as surgical events on the occurrence of reperfusion injury after lung transplantation. Design and setting: Retrospective study in the surgical intensive care unit (ICU) of auniversity hospital. Methods: We collected data on 60 lung transplantation donor/recipient pairs from June1993 to May2001, and compared the demographic, peri- and postoperative variables of patients who experienced reperfusion injury (35%) and those who did not. Results: The occurrence of high systolic pulmonary pressure immediately after transplantation and/or its persistence during the first 48 h after surgery was associated with reperfusion injury, independently of preoperative values. Reperfusion injury was associated with difficult hemostasis during transplantation (p = 0.03). Patients with reperfusion injury were more likely to require the administration of catecholamine during the first 48 h after surgery (p = 0.014). The extubation was delayed (p = 0.03) and the relative odds of ICU mortality were significantly greater (OR 4.8, 95% CI: 1.06, 21.8) in patients with reperfusion injury. Our analysis confirmed that preexisting pulmonary hypertension increased the incidence of reperfusion injury (p < 0.01). Conclusions: Difficulties in perioperative hemostasis were associated with reperfusion injury. Occurrence of reperfusion injury was associated with postoperative systolic pulmonary hypertension, longer mechanical ventilation and higher mortality. Whether early recognition and treatment of pulmonary hypertension during transplantation can prevent the occurrence of reperfusion injury needs to be investigate

Point of care management of heparin administration after heart surgery: A randomized, controlled trial

Objectives: Determination of activated partial thromboplastin time (aPTT) is used in coagulation management after heart surgery. Results from the central laboratory take long to be obtained. We sought to shorten the time to obtain coagulation results and the desired coagulation state and to reduce blood loss and transfusions using point of care (POC) aPTT determination. Design: Randomized, controlled trial. Setting: University-affiliated 20-bed surgical ICU. Patients and participants: Forty-two patients planned for valve surgery (Valves) and 84 for coronary artery bypass grafting (CABG) with cardiopulmonary bypass. Interventions: Valves and CABG were randomized to postoperative coagulation management monitored either by central laboratory aPTT (Lab group) or by POC aPTT (POC group). Heparin was administered according to guidelines. Measurements and results: POC aPTT results were available earlier than Lab aPTT after venipuncture in Valves (3 ± 2 vs. 125 ± 68 min) and in CABG (3 ± 4 vs. 114 ± 62 min). Heparin was introduced earlier in the POC group in Valves (7 ± 23 vs. 13 ± 78 h, p = 0.01). Valves of the POC group bled significantly less than Valves in the Lab group (647 ± 362 ml vs. 992 ± 647ml, p < 0.04), especially during the first 8 h after ICU admission. There was no difference in bleeding in CABG (1074 ± 869 ml vs. 1102 ± 620, p = NS). In Valves, fewer patients in the POC group than in the Lab group needed blood transfusions (1/21 vs. 8/21; p = 0.03). No difference was detected in CABG. Conclusions: In Valves in the POC group the time to the desired coagulation state was reduced, as was the thoracic blood loss, reducing the number of patients transfused. This improvement was not observed in CABG. Side effects were similar in the two group

Evaluation of rapid screening and pre-emptive contact isolation for detecting and controlling methicillin-resistant Staphylococcus aureus in critical care: an interventional cohort study

INTRODUCTION: Rapid diagnostic tests may allow early identification of previously unknown methicillin-resistant Staphylococcus aureus (MRSA) carriers at intensive care unit (ICU) admission. The aim of this study was twofold: first, to assess whether a new molecular MRSA screening test can substantially decrease the time between ICU admission and identification of MRSA carriers; and, second, to examine the combined effect of rapid testing and pre-emptive contact isolation on MRSA infections. METHOD: Since November 2003, patients admitted for longer than 24 hours to two adult ICUs were screened systematically on admission using quick, multiplex immunocapture-coupled PCR (qMRSA). Median time intervals from admission to notification of test results were calculated for a five-month intervention phase (November 2003–March 2004) and compared with a historical control period (April 2003–October 2003) by nonparametric tests. ICU-acquired MRSA infection rates were determined for an extended surveillance period (January 2003 through August 2005) and analyzed by Poisson regression methods. RESULTS: During the intervention phase, 97% (450/462) of patients admitted to the surgical ICU and 80% (470/591) of patients admitted to the medical ICU were screened. On-admission screening identified the prevalence of MRSA to be 6.7% (71/1053). Without admission screening, 55 previously unknown MRSA carriers would have been missed in both ICUs. Median time from ICU admission to notification of test results decreased from 87 to 21 hours in the surgical ICU (P < 0.001) and from 106 to 23 hours in the medical ICU (P < 0.001). In the surgical ICU, 1,227 pre-emptive isolation days for 245 MRSA-negative patients were saved by using the qMRSA test. After adjusting for colonization pressure, the systematic on-admission screening and pre-emptive isolation policy was associated with a reduction in medical ICU acquired MRSA infections (relative risk 0.3, 95% confidence interval 0.1–0.7) but had no effect in the surgical ICU (relative risk 1.0, 95% confidence interval 0.6–1.7). CONCLUSION: The qMRSA test decreased median time to notification from four days to one day and helped to identify previously unknown MRSA carriers rapidly. A strategy linking the rapid screening test to pre-emptive isolation and cohorting of MRSA patients substantially reduced MRSA cross-infections in the medical but not in the surgical ICU

Feasibility of a multiple-choice mini mental state examination for chronically critically ill patients:

Objectives: Following treatment in an ICU, up to 70% of chronically critically ill patients present neurocognitive impairment that can have negative effects on their quality of life, daily activities, and return to work. The Mini Mental State Examination is a simple, widely used tool for neurocognitive assessment. Although of interest when evaluating ICU patients, the current version is restricted to patients who are able to speak. This study aimed to evaluate the feasibility of a visual, multiple-choice Mini Mental State Examination for ICU patients who are unable to speak.Design: The multiple-choice Mini Mental State Examination and the standard Mini Mental State Examination were compared across three different speaking populations. The interrater and intrarater reliabilities of the multiple-choice Mini Mental State Examination were tested on both intubated and tracheostomized ICU patients.Setting: Mixed 36-bed ICU and neuropsychology department in a university hospital.Subjects: Twenty-six healthy volunteers, 20 neurological patients, 46 ICU patients able to speak, and 30 intubated or tracheostomized ICU patients.Interventions: None.Measurements and Main Results: Multiple-choice Mini Mental State Examination results correlated satisfactorily with standard Mini Mental State Examination results in all three speaking groups: healthy volunteers: intraclass correlation coefficient = 0.43 (95% CI, –0.18 to 0.62); neurology patients: 0.90 (95% CI, 0.82–0.95); and ICU patients able to speak: 0.86 (95% CI, 0.70–0.92). The interrater and intrarater reliabilities were good (0.95 [0.87–0.98] and 0.94 [0.31–0.99], respectively). In all populations, a Bland-Altman analysis showed systematically higher scores using the multiple-choice Mini Mental State Examination.Conclusions: Administration of the multiple-choice Mini Mental State Examination to ICU patients was straightforward and produced exploitable results comparable to those of the standard Mini Mental State Examination. It should be of interest for the assessment and monitoring of the neurocognitive performance of chronically critically ill patients during and after their ICU stay. The multiple-choice Mini Mental State Examination tool’s role in neurorehabilitation and its utility in monitoring neurocognitive functions in ICU should be assessed in future studies