Introduction
Life supporting therapy in intensive care units (ICUs) has been increasingly offered to patients with poor long-term prognoses [
1,
2], including those with advanced, end-stage organ dysfunction or a poor functional status [
3‐
5]. While such therapies should not automatically be considered as non-beneficial, they should be provided only to well-informed patients or relatives in accordance with their preferences and values, and only if treatment intensity remains proportional to the expected outcome [
6,
7]. Nevertheless, one in three deaths occurs during or shortly after ICU treatment [
2], frequently following disproportionate levels of care [
8‐
13].
An ethically-based clinical decision-making process has to rely on both individual perceptions and objective criteria, followed by interdisciplinary discussions that enrich the process for the benefit of the patient. However, expressing a perception of excessive care (PEC) to colleagues, and more specifically to senior ones, necessitates a safe climate in which clinicians are empowered to speak up and in which they feel that their opinion is valued and subsequently integrated into the decision-making process [
14]. In addition to enhancing trust and cohesion in a team, such a climate may also reduce uncertainty in decision-makers by favoring intra- and interdisciplinary transfer of knowledge, experience and values [
14]. Several studies have already shown that concordant prognostic estimates [
15,
16] or perceptions of inappropriate [
17] or futile care [
18] by two clinicians may be considerably more predictive about the patient’s short- and long-term outcomes than usually thought. However, whether the quality of the ethical climate prevailing in a unit further improves the identification of patients receiving excessive care, and impacts on patient outcomes and written treatment-limitation decision (TLD), is unknown.
The objectives of the current multicenter study were to assess whether the quality of the ethical climate in an ICU is associated with the prognostic value of PEC(s) with regard to patients’ one-year outcomes and with the time from PEC(s) until written TLD during ICU stay or death. We hypothesized that the better the ethical climate, the more the PEC(s) would be predictive about patients’ one-year outcomes and the shorter the time until written TLD or death.
Discussion
In this large, multicenter, prospective, ICU study, we found that concordant PECs by at least two clinicians were far more predictive about the primary composite endpoint of death, not living at home, or having poor quality of life one year after ICU admission, compared to absence of PEC. We found evidence of a difference in one-year outcomes, time until death and written TLD in patients with concordant PECs across the four ethical climates identified by our questionnaire. The evidence of a difference in time until written TLD disappeared after adjusting for differential case-mix, hospital and country characteristics.
In contrast to the study by Detsky et al. [
16], clinicians in our study were not explicitly expected to provide prognostic estimates about the patients’ outcomes. We preferred to focus on the intuitive-heuristic more than the analytic-deductive part of the complex ethical decision-making process [
26,
27], by asking clinicians whether they felt that the care provided to their patient on a specific day was consistent with the expected outcome in terms of survival and quality of life, and whether this amount of care was in line with the patient’s or relatives’ wishes. We also didn’t focus on futile care, such as in the studies of Neville et al. [
18], because this terminology presupposes a high degree of certainty concerning the final fatal prognosis, whereas nowadays technological innovation frequently excludes patients’ spontaneous death in ICU [
6,
7]. By doing so, we acknowledged uncertainty [
26] (benefit vs. harm) and patient and family autonomy, as an integral part of the complex ethical decision-making process at the bedside [
28]. Nevertheless, PEC was highly predictive about patients’ one-year outcomes, more specifically when expressed by two or more than two clinicians.
Concordant PECs by at least two different clinicians were more predictive about the combined endpoint in the good compared to the poor ethical climate (
P = 0.028). Patients with concordant PECs also had a higher risk of death and of receiving a written TLD in the good compared to the poor climate. The difference in endpoints between the average and the poor climates was less obvious, but still in favor of the former compared to the latter, thus objectively validating our EDMCQ instrument [
14]. Unfortunately, we can neither exclude nor confirm self-fulfilling prophecy in the good climate. However, it is of note that it took about 14 days to identify all patients with concordant PECs in both climates and, for half of these patients, another 5 days to die in the good vs. 14 days in the poor climate (
P = 0.002). In line with the results of the EDMCQ, this suggests that the decision to forgo life sustaining treatment in the good climate was not premature, and once excessive care was perceived by at least two clinicians, it occurred in a timely fashion. Furthermore, in a sub-analysis, we found no difference in risk of death between patients with concordant PECs by different professionals in the poor climate, as opposed to the good climate. This indicates that identification of patients with excessive care by doctors in the poor climate was not followed by active decision-making. In addition to, respectively, increasing the risk of prolonged suffering and complicated grief in patients and relatives [
29,
30], decision-paralysis as a strategy to cope with prognostic uncertainty [
8,
12,
31] may also induce moral distress and increase intention to leave in clinicians [
6,
32‐
34]; a fact that is even more pertinent considering the high number of concordant PEC records perceived as violating the patient’s or relatives’ wishes in this study. After weighting for the specific case-mix within a hospital and country, only the risk of receiving a written TLD in the good compared to the poor climate was no longer significantly different. This may suggest that the quality of the ethical climate in an ICU is important in identifying patients receiving excessive care and in subsequently triggering the decision-making process at end-of-life, whereas formalizing that process via a written TLD seems more case-mix and culture dependent. This is in line with previous studies showing a huge variability in written TLDs between countries and ICUs [
35].
The probability of dying or surviving with a poor quality of life at one year in patients without concordant PECs was 53.5, 59.1, 64.0 and 51.8% from good to poor climate, respectively, largely exceeding that of many malignancies [
36]. Therefore, in line with the definition of disproportionate care [
6,
8,
9], clinicians did not find poor prognosis sufficient by itself to lead to a PEC. Concordant PECs by at least two clinicians increased the probability of reaching the combined endpoint to 100% in the good, 95.6% in the average
(+) and 94.7% in the average
(−) climate, compared to 85.9% in the poor. Despite the poor prognosis we found a relatively low incidence of written TLDs within the 14 days in these patients; ranging from 20% in the poor to only 35% in the good and about 45% in average climates (
P = 0.011). Although caution in interpreting this result is required due to small sample size, these probabilities highlight the urgent need for improving advance-care planning before ICU admission [
37], as well as triage and decision-making at end-of-life in ICU. This should more specifically be achieved via ethical climates that favor interdisciplinary reflection and collaboration [
6,
8,
14,
32,
38,
39], and early involvement of palliative care [
30,
37,
40]. Our EDMCQ instrument may be used for that purpose [
14,
32].
Our study has several limitations. First, the participating ICUs were not selected at random, which may have affected the external validity of our results. Second, inclusion of patients was left at the discretion of the attending doctor. However, except in the average
(−) climate (ESM 2), we found no evidence of a difference in ICU mortality rates or length of stay in the subgroup of patients admitted for monitoring only across climates, indicating that the attending doctors included patients in a similar way. We further minimized confounding bias by accounting for differences in case-mix, using inverse probability weighting based on propensity scores. Third, we did not use classical severity-of-illness scores in our analysis. However, in line with our primary objective, we preferred to include short- and long-term prognostic factors [
4,
5] that are commonly used by clinicians during decision-making, rather than classical severity-of-illness scores which have never been validated for predicting long-term outcomes. Fourth, one has to keep in mind that the incidence of patients with concordant PECs is probably underestimated, as patients admitted prior to the study period and those who remained in ICU for longer than the study period (and were expected to reach more clinician concordance with time) were excluded from the analysis. Finally, although the ICU experience of clinicians was similar, we cannot exclude that the lower number of participating doctors in the good compared to the poor climate may have biased our results in favor of the latter, concealing even larger differences between the two.
Acknowledgements
This study was supported by a European Society of Intensive Care Medicine/European Critical Care Research Network clinical research award and a Fonds voor Wetenschappelijk Onderzoek senior clinical investigators grant (1800513N) obtained in 2012 by DB. We are grateful to Ariella Van Sompel for having performed the factor and cluster analysis together with VDB and RP (under supervision of SVH and SVS) and Jolien Roels for having performed the data cleaning and the univariate analysis (under supervision of DB, SVB and SVS). Participating centers and local investigators: Belgium: University Hospital, Vrije Universiteit Brussel, Brussels (Herbert Spapen, Marie-Claire Van Malderen, Godelieve Opdenacker), Leuven University Hospital, Leuven (Geert Meyfroidt, Dieter Mesotten, Joost Wauters, Marie Van Laer and Alexander Wilmer, Joost Wauters, Helga Ceunen), ZNA Stuivenberg, Antwerpen (Inneke E De Laet, Anita Jans), Ghent University Hospital, Gent (Dominique Benoit, Sandra Oeyen, Ingrid Herck, Stephanie Bracke, Charlotte Clauwaert), Institut Jules Bordet, Bruxelles (Meert Anne-Pascale, Leclercq Nathalie), CHU-Brugmann, Bruxelles (Devriendt Jacques), CHU Saint Pierre, Bruxelles (Dechamps Philippe), Czech Republic: Liberec District Hospital, Liberec (Ivana Zykova), Masaryk University, Brno and University Hospital, Brno (Jan Malaska), Third Faculty of Medicine, Charles University, Prague (Matous Schmidt), Hospital and Polyclinic Havirov, Havirov (Igor Satinsky), Institute for Experimental and Clinical Medicine, Prague (Eva Kieslichova), 3rd Medical Department, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague (Jarmila Krizova), Karlovy Vary District Hospital, Karlovy Vary (Robert Janda), Pardubice District Hospital, Pardubice (Magdalena Fortova, Jiri Matyas), First Faculty of Medicine, Charles University and General University Hospital, Prague (Katerina Rusinova, Ondrej Kopecky), Denmark: Herning Hospital, Herning (Christian Alves Køhler Pedersen), Kolding Hospital, Kolding (Stine Hebsgaard), Vejle Hospital, Vejle (Rikke Frank Aagaard Johnsen), Holbæk Hospital, Holbæk (Tina Charlotte Bitsch Hansen), France: Saint-Etienne University Hospital and Jacques Lisfranc Medical School, Saint-Etienne (Michael Darmon), Saint-Louis University Hospital, APHP, Université Paris-7, Paris (Danielle Reuter, Elie Azoulay), Institut Paoli Calmette, Marseilles (Djamel Mokart), Montfermeil Hospital, Montfermeil (François Vincent), Germany: University Hospital Jena, Jena (Christiane S. Hartog), Viersen General Hospital, Viersen (Peter Gretenkort), Tettnang Hospital, Tettnang (Andrej Michalsen), Greece: Agia Olga Hospital, Athens (Aikaterini Kounougeri), Evangelismos Hospital, Athens (Serafim Nanas), Agios Pavlos Hospital, Thessaloniki (Despina Papachristou), AHEPA University Hospital, Thessaloniki, (Ioanna Soultati), G.Gennimatas Hospital, Thessaloniki (Dimitrios Lathyris), Hippokratio General Hospital, Thessaloniki (Marili Pasakiotou), Papageorgiou General Hospital, Thessaloniki (Marina Oikonomou), Hungary: Semmelweis University Budapest, Budapest (Gábor Élő, Orsolya Szűcs), Kaposi Mór Teaching Hospital, Kaposvár University, Kaposvár (János Fogas), St. Stephen and St. Leslie Metropolitan Hospital, Budapest (Ilona Bobek), Italy: Azienda Ospedaliero Universitaria, “Maggiore della Carità”, Novara, and Department of Translational Medicine, Università del Piemonte Orientale, Novara (Francesco Della Corte, Carlo Olivieri, Rosanna Vaschetto, Laura Cancelliere), Ospedale Civile San Salvatore, and Department of Life, Health and Environmental Sciences (MeSVA), University of L’Aquila and Department of Emergency, San Salvatore Hospital, L’Aquila (Franco Marinangeli, Tullio Pozone, Alessandra Ciccozzi), The Netherlands: Canisius Wilhelmina Ziekenhuis, Nijmegen (A. Schouten, Monique Bruns), Medical Center Leeuwarden, Leeuwarden (Rik T. Gerritsen, Matty Koopmans), Erasmus University Hospital of Rotterdam (Erwin Kompanje, Ditty van Duijn), University of Groningen and University Medical Center Groningen, Groningen (Jan G. Zijlstra, Anne KL Reyners), Wilhelmina Ziekenhuis Assen, Assen (Johan G. Lutisan), Portugal: Hospital S.António, Porto (Raquel Monte, José António Pinho, Pedro Pimenta), CHVNG, Vila Nova de Gaia (Paula Fernandes, Ana Isabel Paixão), Instituto Português de Oncologia, Porto (Filomena Faria), Sweden: Sahlgrenska University Hospital, Gothenburg (Johan A. Malmgren), Sahlgrenska University Hospital/Östra, Gothenburg (Bertil Andersson), Skåne University Hospital, Malmö (Eva Åkerman), Karolinska University Hospital, Karolinska (Andreas Hvarfner), The Hospital of Norrköping, Norrköping (Robert Svensson), United Kingdom: King’s College Hospital, London (Victoria Metaxa), USA: Beth Israel Deaconess Medical Center and Harvard Medical School, Boston MA (Daniel Talmor, Ariel Mueller, Valerie Banner-Goodspeed), Henry Mayo Newhall Memorial Hospital, Valencia, CA (Dee Rickett), Mayo Clinic, Rochester, MN (Michael E. Wilson, Richard Hinds).