The longitudinal study of subjective wellbeing and absenteeism of healthcare workers considering post-COVID condition and the COVID-19 pandemic toll.

Experts have warned against the pandemic burden on healthcare workers early on, however little is known about the evolution of this burden with time, in addition to the long-term effects of post-COVID symptoms in healthcare workers. Staff at the Geneva University Hospitals in Switzerland had an online follow-up in July and December 2021, on their physical and mental health, quality of life and functional capacity using validated scales. Descriptive analyses compared the prevalence of symptoms, functional impairment and quality of life in SARS-CoV-2 positive and negative individuals at baseline and at follow-up. Out of the initial n = 3,083 participants that answered at baseline in July 2021, n = 900 (mean age of 46.4 years, 70.1% women) completed the follow-up in December 2021. With time, more individuals reported fatigue (+ 9.4%), headache (+ 9.0%), insomnia (+ 2.3%), cognitive impairment (+ 1.4%), stress/burnout (+ 8.8%), pain (+ 8.3%), digestive symptoms (+ 3.6%), dyspnea (+ 1.0%), and cough (+ 7.7%) compared to baseline, with a differentially larger increase in symptoms in the SARS-CoV-2 negative group. Individuals had more functional impairment (12.7% at baseline and 23.9% at follow-up), with more absenteeism and worsening quality of life. Healthcare workers are potentially suffering from long term consequences of the pandemic burden, calling for urgent action and solutions.

The pandemic toll and post-acute sequelae of SARS-CoV-2 in healthcare workers at a Swiss University Hospital.

Healthcare workers have potentially been among the most exposed to SARS-CoV-2 infection as well as the deleterious toll of the pandemic. This study has the objective to differentiate the pandemic toll from post-acute sequelae of SARS-CoV-2 infection in healthcare workers compared to the general population. The study was conducted between April and July 2021 at the Geneva University Hospitals, Switzerland. Eligible participants were all tested staff, and outpatient individuals tested for SARS-CoV-2 at the same hospital. The primary outcome was the prevalence of symptoms in healthcare workers compared to the general population, with measures of COVID-related symptoms and functional impairment, using prevalence estimates and multivariable logistic regression models. Healthcare workers (n = 3083) suffered mostly from fatigue (25.5 %), headache (10.0 %), difficulty concentrating (7.9 %), exhaustion/burnout (7.1 %), insomnia (6.2 %), myalgia (6.7 %) and arthralgia (6.3 %). Regardless of SARS-CoV-2 infection, all symptoms were significantly higher in healthcare workers than the general population (n = 3556). SARS-CoV-2 infection in healthcare workers was associated with loss or change in smell, loss or change in taste, palpitations, dyspnea, difficulty concentrating, fatigue, and headache. Functional impairment was more significant in healthcare workers compared to the general population (aOR 2.28; 1.76-2.96), with a positive association with SARS-CoV-2 infection (aOR 3.81; 2.59-5.60). Symptoms and functional impairment in healthcare workers were increased compared to the general population, and potentially related to the pandemic toll as well as post-acute sequelae of SARS-CoV-2 infection. These findings are of concern, considering the essential role of healthcare workers in caring for all patients including and beyond COVID-19.

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 research.

Research in critically ill patients: standards of informed consent.

Patients in critical care lose their capability to make a judgement, and constitute a 'vulnerable population' needing special and reinforced protection. Even if the standard of informed consent is an essential way of demonstrating respect for the patient's autonomy, the usual informed-consent procedure is not as applicable as required or sufficient to warrant this ethical principle in critical care.

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.

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 +/- 647 ml, 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 groups.

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 a tertiary teaching university hospital and the ward before and after ICU. PATIENTS: Patients, scheduled for elective cardiac surgery, who accepted to participate in a coagulation 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 August 2001, we included 38 patients; 36 survived ICU. Ten to 12 days after surgery, 8/36 (22%) patients did not know they had participated in a study, 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) vs 3 (1-5) days; p = 0.004]. None of these patients (0/9 vs 10/27; 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, a substantial 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 participation.

Low apolipoprotein A-I level at intensive care unit admission and systemic inflammatory response syndrome exacerbation.

OBJECTIVE: Examine whether a low serum level of apolipoprotein A-I at intensive care unit (ICU) admission is associated with a further increase of the number of systemic inflammatory response syndrome (SIRS) criteria. DESIGN: Prospective observational study. SETTING: A 20-bed, university-affiliated, surgical ICU. PATIENTS: Patients admitted after major surgery, multiple trauma, or acute pancreatitis without septic shock. INTERVENTIONS: We defined as the SIRS Exacerb group patients who presented a further increase of the number of SIRS criteria during their ICU stay or, in the presence of four SIRS criteria at ICU admission, those who presented a further aggravation of organ failure. Other patients were attributed to the SIRS No Exacerb group. From day 1 to 6, we measured apolipoprotein A-I, high-density lipoprotein and total cholesterol, triglycerides, C-reactive protein, procalcitonin, serum amyloid A, interleukin 6, interleukin-1 receptor antagonist, albumin, and other nutrition-linked variables. We looked at laboratory values or factors present at ICU admission according to the two groups. MEASUREMENTS AND MAIN RESULTS: From 63 patients analyzed, 29 (46%) were assigned to the SIRS Exacerb group. Age, sex, and SAPS II and SIRS scores at ICU admission did not differ between the groups. Patients in the SIRS Exacerb group presented more often a septic event (5/29 vs. 0/34, p =.02), had a higher hospital mortality (6/29 vs. 0/34, p =.007), and had a longer ICU stay (p =.0023). At admission, inflammatory variables such as the C-reactive protein, serum amyloid A, interleukin 6, interleukin-1 receptor antagonist plasma levels, and other lipid or nutrition-linked variables were similar between the two groups. Apolipoprotein A-I levels were lower in the SIRS Exacerb group (median [interquartile range]: 68 [56-81] vs. 84 [69-94] mg/dL, p =.028). CONCLUSION: A low serum level of apolipoprotein A-I at ICU admission is associated with an increase of the number of SIRS criteria during the ICU stay.