The hidden curriculum across medical disciplines: an examination of scope, impact, and context.

Background: While research suggests that manifestations of the hidden curriculum (HC) phenomenon have the potential to reinforce or undermine the values of an institution, very few studies have comprehensively measured its scope, impact, and the varied clinical teaching and learning contexts within which they occur. We explored the HC and examined the validity of newly developed constructs and determined the influence of context on the HC. Methods: We surveyed medical students (n =182), residents (n =148), and faculty (n = 140) from all disciplines at our institution between 2019 and 2020. Based on prior research and expertise, we measured participants' experience with the HC including perceptions of respect and disrespect for different medical disciplines, settings in which the HC is experienced, impact of the HC, personal actions, efficacy, and their institutional perceptions. We examined the factor structure, reliability, and validity of the HC constructs using exploratory factor analysis Cronbach's alpha, regression analysis and Pearson's correlations. Results: Expert judges (physician faculty and medical learners) confirmed the content validity of the items used and the analysis revealed new HC constructs reflecting negative expressions, positive impacts and expressions, negative impacts, personal actions, and positive institutional perceptions of the HC. Evidence for criterion validity was found for the negative impacts and the personal actions constructs and were significantly associated with the stage of respondents' career and gender. Support for convergent validity was obtained for HC constructs that were significantly correlated with certain contexts within which the HC occurs. Conclusion: More unique dimensions and contexts of the HC exist than have been previously documented. The findings demonstrate that specific clinical contexts can be targeted to improve negative expressions and impacts of the HC.

Contexte: Bien que la recherche suggère que les expressions du curriculum caché (CC) ont le potentiel de renforcer ou de miner les valeurs d'un établissement, très peu d'études ont mesuré de manière exhaustive sa portée, ses effets et les divers contextes d'enseignement et d'apprentissage cliniques dans lesquels elles se produisent. Nous avons exploré le CC, examiné la validité de nouvelles notions et déterminé l'influence du contexte sur le CC. Méthodes: Entre 2019 et 2020, nous avons interrogé des étudiants (n =182), des résidents (n =148) et des membres du corps professoral (n = 140) de notre établissement, toutes disciplines médicales confondues. Sur la base de recherches et d'expertises antérieures, nous avons mesuré l'expérience des participants par rapport au CC, y compris leurs perceptions du respect ou du non-respect des diverses disciplines médicales, les contextes dans lesquels ils ont été confrontés au CC, les effets et l'efficacité du CC, les perceptions de l'établissement et les actions personnelles des participants. Nous avons examiné la structure factorielle, la fiabilité et la validité des notions du CC à l'aide d'une analyse factorielle exploratoire, du coefficient alpha de Cronbach, d'une analyse de régression et des corrélations de Pearson. Résultats: Des juges experts (médecins enseignants et apprenants) ont confirmé la validité du contenu des éléments utilisés et l'analyse a révélé de nouvelles notions du CC reflétant des expressions et des effets négatifs, des expressions et des effets positifs, des actions personnelles et des perceptions positives du CC au sein des établissements. La validité de critère a été démontrée pour les notions d'impacts négatifs et d'actions personnelles et a été associée de manière significative à l'étape de la carrière des répondants et à leur sexe. La validité convergente a été confirmée pour les notions de CC qui étaient significativement corrélées à certains contextes dans lesquels le CC se manifeste. Conclusion: Il existe plus de dimensions et de contextes uniques du CC que ceux qui avaient été documentés par le passé. Nos résultats montrent que des contextes cliniques spécifiques peuvent être ciblés pour améliorer les expressions et les effets négatifs du CC.

Airway injury from the presence of endotracheal tubes and the association with subglottic secretion drainage: a prospective observational study.

PURPOSE: Laryngeal and tracheal injuries are known complications of endotracheal intubation. Endotracheal tubes (ETTs) with subglottic suction devices (SSDs) are commonly used in the critical care setting. There is concern that herniation of tissue into the suction port of these devices may lead to tracheal injury resulting in serious clinical consequences such as tracheal stenosis. We aimed to describe the type and location of tracheal injuries seen in intubated critically ill patients and assess injuries at the suction port as well as in-hospital complications associated with those injuries. METHODS: We conducted a prospective observational study of 57 critically ill patients admitted to a level 3 intensive care unit who were endotracheally intubated and underwent percutaneous tracheostomy. Investigators performed bronchoscopy and photographic evaluation of the airway during the percutaneous tracheostomy procedure to evaluate tracheal and laryngeal injury. RESULTS: Forty-one (72%) patients intubated with ETT with SSD and sixteen (28%) patients with standard ETT were included in the study. Forty-seven (83%) patients had a documented airway injury ranging from hyperemia to deep ulceration of the mucosa. A common tracheal injury was at the site of the tracheal cuff. Injury at the site of the subglottic suction device was seen in 5/41 (12%) patients. There were no in-hospital complications. CONCLUSIONS: Airway injury was common in critically ill patients following endotracheal intubation, and tracheal injury commonly occurred at the site of the endotracheal cuff. Injury occurred at the site of the subglottic suction port in some patients although the clinical consequences of these injuries remain unclear.

RéSUMé: OBJECTIF: Les lésions laryngées et trachéales sont des complications connues de l'intubation endotrachéale. Les sondes endotrachéales (SET) avec dispositifs d'aspiration sous-glottiques (DASG) sont couramment utilisées aux soins intensifs. On craint qu'une hernie tissulaire dans l'orifice d'aspiration de ces dispositifs n'entraîne des lésions trachéales, résultant en de graves conséquences cliniques telles qu'une sténose trachéale. Nous avons cherché à décrire le type et l'emplacement des lésions trachéales observées chez les patients gravement malades intubés et à évaluer les lésions au port d'aspiration ainsi que les complications hospitalières associées à ces lésions. MéTHODE: Nous avons mené une étude observationnelle prospective auprès de 57 patients gravement malades admis dans une unité de soins intensifs de niveau 3 qui ont été intubés par voie endotrachéale et ont subi une trachéostomie percutanée. Les chercheurs ont réalisé une bronchoscopie et une évaluation photographique des voies aériennes au cours de la trachéostomie percutanée afin d'évaluer les lésions trachéales et laryngées. RéSULTATS: Quarante et un (72 %) intubés par SET avec DASG et seize (28 %) patients avec SET standard ont été inclus dans l'étude. Quarante-sept (83 %) patients ont présenté une lésion documentée des voies aériennes allant de l'hyperémie à l'ulcération profonde de la muqueuse. Une lésion trachéale commune était localisée sur le site du ballonnet trachéal. Une lésion au site du dispositif d'aspiration sous-glottique a été observée chez 5/41 (12 %) patients. Il n'y a pas eu de complications à l'hôpital. CONCLUSION: Les lésions des voies aériennes étaient fréquentes chez les patients gravement malades après une intubation endotrachéale, et les lésions trachéales se produisaient généralement au site du ballonnet endotrachéal. Des lésions se sont produites au site de l'orifice d'aspiration sous-glottique chez certains patients, bien que les conséquences cliniques de ces lésions restent incertaines.

Wellness and Coping of Physicians Who Worked in ICUs During the Pandemic: A Multicenter Cross-Sectional North American Survey.

OBJECTIVES: Few surveys have focused on physician moral distress, burnout, and professional fulfilment. We assessed physician wellness and coping during the COVID-19 pandemic. DESIGN: Cross-sectional survey using four validated instruments. SETTING: Sixty-two sites in Canada and the United States. SUBJECTS: Attending physicians (adult, pediatric; intensivist, nonintensivist) who worked in North American ICUs. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: We analysed 431 questionnaires (43.3% response rate) from 25 states and eight provinces. Respondents were predominantly male (229 [55.6%]) and in practice for 11.8 ± 9.8 years. Compared with prepandemic, respondents reported significant intrapandemic increases in days worked/mo, ICU bed occupancy, and self-reported moral distress (240 [56.9%]) and burnout (259 [63.8%]). Of the 10 top-ranked items that incited moral distress, most pertained to regulatory/organizational ( n = 6) or local/institutional ( n = 2) issues or both ( n = 2). Average moral distress (95.6 ± 66.9), professional fulfilment (6.5 ± 2.1), and burnout scores (3.6 ± 2.0) were moderate with 227 physicians (54.6%) meeting burnout criteria. A significant dose-response existed between COVID-19 patient volume and moral distress scores. Physicians who worked more days/mo and more scheduled in-house nightshifts, especially combined with more unscheduled in-house nightshifts, experienced significantly more moral distress. One in five physicians used at least one maladaptive coping strategy. We identified four coping profiles (active/social, avoidant, mixed/ambivalent, infrequent) that were associated with significant differences across all wellness measures. CONCLUSIONS: Despite moderate intrapandemic moral distress and burnout, physicians experienced moderate professional fulfilment. However, one in five physicians used at least one maladaptive coping strategy. We highlight potentially modifiable factors at individual, institutional, and regulatory levels to enhance physician wellness.

The role of nutrition rehabilitation in the recovery of survivors of critical illness: underrecognized and underappreciated.

Many survivors of critical illness face significant physical and psychological disability following discharge from the intensive care unit (ICU). They are often malnourished, a condition associated with poor outcomes, and nutrition remains problematic particularly in the early phases of ICU recovery. Yet nutrition rehabilitation, the process of restoring or optimizing nutritional status following illness, is seldom prioritized, possibly because it is an underrecognized and underappreciated area in critical care rehabilitation and research. To date, 16 original studies have been published where one of the objectives includes measurement of indices relating to nutritional status (e.g., nutrition intake or factors impacting nutrition intake) in ICU survivors. The primary aim of this narrative review is to provide a comprehensive summary of key themes arising from these studies which form the basis of our current understanding of nutritional recovery and rehabilitation in ICU survivors. ICU survivors face a multitude of barriers in achieving optimal nutrition that are of physiological (e.g., poor appetite and early satiety), functional (e.g., dysphagia, reduced ability to feed independently), and psychological (e.g., low mood, body dysmorphia) origins. Organizational-related barriers such as inappropriate feeding times and meal interruptions frequently impact an ICU survivor's ability to eat. Healthcare providers working on wards frequently lack knowledge of the specific needs of recovering critically ill patients which can negatively impact post-ICU nutrition care. Unsurprisingly, nutrition intake is largely inadequate following ICU discharge, with the largest deficits occurring in those who have had enteral nutrition prematurely discontinued and rely on an oral diet as their only source of nutrition. With consideration to themes arising from this review, pragmatic strategies to improve nutrition rehabilitation are explored and directions for future research in the field of post-ICU nutrition recovery and rehabilitation are discussed. Given the interplay between nutrition and physical and psychological health, it is imperative that enhancing the nutritional status of an ICU survivor is considered when developing multidisciplinary rehabilitation strategies. It must also be recognized that dietitians are experts in the field of nutrition and should be included in stakeholder meetings that aim to enhance ICU rehabilitation strategies and improve outcomes for survivors of critical illness.

Dietary Management of Blood Glucose in Medical Critically Ill Overweight and Obese Patients: An Open-Label Randomized Trial.

BACKGROUND: Enteral nutrition (EN) increases hyperglycemia due to high carbohydrate concentrations while providing insufficient protein. The study tested whether an EN formula with very high-protein- and low-carbohydrate-facilitated glucose control delivered higher protein concentrations within a hypocaloric protocol. METHODS: This was a multicenter, randomized, open-label clinical trial with parallel design in overweight/obese mechanically ventilated critically ill patients prescribed 1.5 g protein/kg ideal body weight/day. Patients received either an experimental very high-protein (37%) and low-carbohydrate (29%) or control high-protein (25%) and conventional-carbohydrate (45%) EN formula. RESULTS: A prespecified interim analysis was performed after enrollment of 105 patients (52 experimental, 53 control). Protein and energy delivery for controls and experimental groups on days 1-5 were 1.2 ± 0.4 and 1.1 ± 0.3 g/kg ideal body weight/day (P = .83), and 18.2 ± 6.0 and 12.5 ± 3.7 kcals/kg ideal body weight/day (P < .0001), respectively. The combined rate of glucose events outside the range of >110 and ≤150 mg/dL were not different (P = .54, primary endpoint); thereby the trial was terminated. The mean blood glucose for the control and the experimental groups were 138 (-SD 108, +SD 177) and 126 (-SD 99, +SD 160) mg/dL (P = .004), respectively. Mean rate of glucose events >150 mg/dL decreased (Δ = -13%, P = .015), whereas that of 80-110 mg/dL increased (Δ = 14%, P = .0007). Insulin administration decreased 10.9% (95% CI, -22% to 0.1%; P = .048) in the experimental group relative to the controls. Glycemic events ≤80 mg/dL and rescue dextrose use were not different (P = .23 and P = .53). CONCLUSIONS: A very high-protein and low-carbohydrate EN formula in a hypocaloric protocol reduces hyperglycemic events and insulin requirements while increasing glycemic events between 80-110 mg/dL.

Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial.

Background: Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. Principles of treatment include early antibiotic administration and operative source control. A further therapeutic option may be open abdomen (OA) management with active negative peritoneal pressure therapy (ANPPT) to remove inflammatory ascites and ameliorate the systemic damage from SCIAS. Although there is now a biologic rationale for such an intervention as well as non-standardized and erratic clinical utilization, this remains a novel therapy with potential side effects and clinical equipoise. Methods: The Closed Or Open after Laparotomy (COOL) study will constitute a prospective randomized controlled trial that will randomly allocate eligible surgical patients intra-operatively to either formal closure of the fascia or use of the OA with application of an ANPTT dressing. Patients will be eligible if they have free uncontained intra-peritoneal contamination and physiologic derangements exemplified by septic shock OR a Predisposition-Infection-Response-Organ Dysfunction Score ≥ 3 or a World-Society-of-Emergency-Surgery-Sepsis-Severity-Score ≥ 8. The primary outcome will be 90-day survival. Secondary outcomes will be logistical, physiologic, safety, bio-mediators, microbiological, quality of life, and health-care costs. Secondary outcomes will include days free of ICU, ventilation, renal replacement therapy, and hospital at 30 days from the index laparotomy. Physiologic secondary outcomes will include changes in intensive care unit illness severity scores after laparotomy. Bio-mediator outcomes for participating centers will involve measurement of interleukin (IL)-6 and IL-10, procalcitonin, activated protein C (APC), high-mobility group box protein-1, complement factors, and mitochondrial DNA. Economic outcomes will comprise standard costing for utilization of health-care resources. Discussion: Although facial closure after SCIAS is considered the current standard of care, many reports are suggesting that OA management may improve outcomes in these patients. This trial will be powered to demonstrate a mortality difference in this highly lethal and morbid condition to ensure critically ill patients are receiving the best care possible and not being harmed by inappropriate therapies based on opinion only. Trial registration: ClinicalTrials.gov, NCT03163095.

Defining and Using Preoperative Predictors of Diabetic Remission Following Bariatric Surgery.

BACKGROUND: Diabetes remission is defined as the return of glycemic control in the absence of medication or insulin use after bariatric surgery. We sought to identify and assess the clinical utility of a predictive model for remission of type 2 diabetes mellitus in a population seeking bariatric surgery. METHOD: A retrospective cohort design was applied to presurgical data on patients referred for Roux-en-Y gastric bypass (RYGB) or vertical sleeve gastrectomy (VSG). The model developed from logistic regression was compared with a published model through receiver operating characteristic analyses. RESULTS: At 12 months postoperatively, 59.7% of the cohort was remitted, with no differences between RYGB and VSG. Logistic regression analyses yielded a model in which 4 preoperative variables reliably predicted remission. A Hosmer-Lemeshow goodness-of-fit test result of 0.204 indicated good fit of the developed prediction model to our outcome data. The predictive accuracy of this prediction model was compared with a published model, and an associated variation with diabetes years was substituted for age in our patient population. Our model was the most accurate. CONCLUSIONS: Using these predictors, healthcare providers may be able to better counsel patients who are living with diabetes and considering bariatric surgery on the likelihood of achieving remission from the intervention. This refined prediction model requires further testing in a larger sample to evaluate its external validity.

Headspace volatile components of Canadian grown low-tannin faba bean (Vicia faba L.) genotypes.

BACKGROUND: As flavor is a prerequisite for palatability of new crop varieties, 13 Canadian-grown, low-tannin faba bean genotypes were evaluated for volatile components isolated with headspace solid-phase microextraction, and analyzed with gas chromatography-mass spectrometry. RESULTS: A total of 45 volatiles consisting of aldehydes, aromatic hydrocarbons, alcohols, ketones and alkanes represented on average 57, 15, 14, 5 and 4.5% of the total peak area, respectively. Total extractable volatiles were highly location dependent, whereas 10 headspace volatiles (1-pentanol, 1-hexanol, pentanal, (E)-2-heptenal, 2-ethylfuran, 2-pentylfuran, acetone, 2-butanone, 2-heptanone and 3-octen-2-one) were genotype specific and/or regulated by environmental conditions. Multivariate data analysis performed on the functional group of the volatiles using principal component analysis and cluster analysis demonstrates that the total extractable volatiles were the major factor segregating faba bean genotypes. CONCLUSION: The solid-phase microextraction technique proved to be a rapid and effective method for routine evaluation of faba bean volatile profile that may be applicable in a screening/plant breeding program.

Elderly persons with ICU-acquired weakness: the potential role for ß-hydroxy-ß-methylbutyrate (HMB) supplementation?

Intensive care unit (ICU)-acquired weakness is common and characterized by muscle loss, weakness, and paralysis. It is associated with poor short-term outcomes, including increased mortality, but the consequences of reduced long-term outcomes, including decreased physical function and quality of life, can be just as devastating. ICU-acquired weakness is particularly relevant to elderly patients who are increasingly consuming ICU resources and are at increased risk for ICU-acquired weakness and complications, including mortality. Elderly patients often enter critical illness with reduced muscle mass and function and are also at increased risk for accelerated disuse atrophy with acute illness. Increasingly, intensivists and researchers are focusing on strategies and therapies aimed at improving long-term neuromuscular function. ß-Hydroxy-ß-methylbutyrate (HMB), an ergogenic supplement, has shown efficacy in elderly patients and certain clinical populations in counteracting muscle loss. The present review discusses ICU-acquired weakness, as well as the unique physiology of muscle loss and skeletal muscle function in elderly patients, and then summarizes the evidence for HMB in elderly patients and in clinical populations. We subsequently postulate on the potential role and strategies in studying HMB in elderly ICU patients to improve muscle mass and function.

Clinical evidence for pharmaconutrition in major elective surgery.

In recent years, standard nutrition preparations have been modified by adding specific nutrients, such as arginine, ω-3 fatty acids, glutamine, and others, which have been shown to upregulate host immune response, modulate inflammatory response, and improve protein synthesis after surgery. Most randomized trials and several meta-analyses have shown that perioperative administration of enteral arginine, ω-3 fatty acids, and nucleotides (immunonutrition) reduced infection rate and length of hospital stay in patients with upper and lower gastrointestinal (GI) cancer. The most pronounced benefits of immunonutrition were found in subgroups of high-risk and malnourished patients. Promising but not conclusive results have been found in non-GI surgery, especially in head and neck surgery and in cardiac surgery, but larger trials are required before recommending immunonutrition as a routine practice. Conflicting results on the real benefit of parenteral glutamine supplementation in patients undergoing elective major surgery have been published. In conclusion, enteral diets supplemented with specific nutrients significantly improved short-term outcome in patients with cancer undergoing elective GI surgery. Future research should investigate a molecular signaling pathway and identify specific mechanisms of action of immune-enhancing substrates.

Driving perioperative nutrition quality improvement processes forward!

Evidence supporting the important role of nutrition therapy in surgical patients has evolved, with several randomized trials and meta-analyses of randomized trials clearly demonstrating benefits. Despite this evidence, surgeons and anesthesiologists have been slow to adopt recommended practices, and the traditional dogma of delaying the initiation of and restricting the amount of nutrition during the postoperative period persists. Consequently, the nutrition therapy received by surgical patients remains suboptimal; thus, patients suffer worse clinical outcomes. Knowledge translation (KT) describes the process of moving evidence learned from clinical research, and summarized in clinical practice guidelines, to its incorporation into clinical and policy decision making. In this paper, we apply Graham et al's knowledge-to-action model to illuminate our understanding of the issues pertinent to KT in surgical nutrition. We illustrate various components of this model using empirically derived research, commentaries, and published studies from both critical care and surgical nutrition. Barriers to improving surgical nutrition practice may be related to (1) the nature of the underlying evidence and clinical practice guidelines; (2) guideline implementation factors; (3) characteristics of the health system, hospital, and surgical team; (4) provider attitudes and beliefs; and (5) patient factors (eg, type of surgery, underlying disease, and nutrition status). Interventions tailored to overcoming these barriers must be developed, evaluated, and implemented. A system of audit and feedback must guide this process and evaluate improvements over time so that every patient undergoing major surgery will have the opportunity to be optimally assessed and managed according to best nutrition practices.

Nutrition therapy of the severely obese, critically ill patient: summation of conclusions and recommendations.

This report compiles the conclusions and recommendations for nutrition therapy of the obese, critically ill patient derived by the group of experts participating in this workshop on obesity in critical care nutrition. The recommendations are based on consensus opinions of the group after review of the current literature. Obesity clearly adds to the complexity of nutrition therapy in the intensive care unit (ICU). Obesity alters the incidence and severity of comorbidities, tolerance of the prescribed regimen, and ultimately patient outcome through the course of hospitalization. Although the basic principles of critical care nutrition apply to the obese ICU patient, a high-protein, hypocaloric regimen should be provided to reduce the fat mass, improve insulin sensitivity, and preserve lean body mass. The ideal enteral formula should have a low nonprotein calorie to nitrogen ratio and have a variety of pharmaconutrient agents added to modulate immune responses and reduce inflammation.

Current strategies of critical care assessment and therapy of the obese patient (hypocaloric feeding): what are we doing and what do we need to do?

Two of the most challenging issues in the clinical management of the obese patient are assessing energy requirements and whether hypocaloric (permissive) underfeeding should be employed. Multiple predictive equations have been used in the literature to estimate resting metabolic rate, although no consensus has emerged regarding which prediction equation is most accurate and precise in the obese population. Hypocaloric, or permissive underfeeding, specifically refers to the intentional administration of calories that are less than predicted energy expenditure. Thus far, very few studies performed have been performed to assess the efficacy of hypocaloric feeding in the obese hospitalized patient. It is concluded that the optimal caloric intake of obese patients in the intensive care unit remains unclear given the limitation of the existing data.

Monitoring nutrition therapy in the critically ill patient with obesity.

Obesity compounds the metabolic response to critical illness and augments the consequences of overfeeding. Effective monitoring is essential for the prevention of, or to avoid, worsening of preexistent morbidities associated with obesity during the implementation of specialized nutrition support. This monitoring should guide the clinician toward the selection of appropriate therapeutic options to reduce complications from significant hyperglycemia, dyslipidemia, hypercapnia, fluid overload, and worsening of hepatic steatosis. Conventional nutrition outcome markers should be employed, with their limitations understood, when used for the critically ill obese patient.

Phenolics, phytic acid, and phytase in Canadian-grown low-tannin faba bean (Vicia faba L.) genotypes.

Thirteen low-tannin faba bean genotypes grown at two locations in north central Alberta in 2009 were evaluated to investigate the variation in seed characteristics, phenolic and phytate contents, and phytase and antioxidant activities and to elucidate the relationship of these components as a breeding strategy. Seed characteristics including color were predominantly genotype dependent. The faba bean genotypes with total phenolic content ranging from 5.5 to 41.8 mg of catechin equiv/g of sample was linearly related to tannin content and the best predictor of antioxidant activity. Phytic acid content and phytase activity varied significantly among genotypes and between locations, ranging from 5.9 to 15.1 g/kg and from 1606 to 2154 FTU/kg sample, respectively. Multivariate data analysis performed on 19 components analyzed in this study using principal component analysis (PCA) and cluster analysis demonstrate that differences in seed characteristics, phenolic components, phytic acid, and phytase are major factors in segregating faba bean genotypes. The relatively low phytic acid content and high phytase activity of these low-tannin faba bean genotypes are beneficial/essential traits for their use in human and animal nutrition.

Persistent organ dysfunction plus death: a novel, composite outcome measure for critical care trials.

INTRODUCTION: Due to resource limitations, few critical care interventions have been rigorously evaluated with adequately powered randomized clinical trials (RCTs). There is a need to improve the efficiency of RCTs in critical care so that more definitive high quality RCTs can be completed with the available resources. The objective of this study was to validate and demonstrate the utility of a novel composite outcome measure, persistent organ dysfunction (POD) plus death, for clinical trials of critically ill patients. METHODS: We performed a secondary analysis of a dataset from a prospective randomized trial involving 38 intensive care units (ICUs) in Canada, Europe, and the United States. We define POD as the persistence of organ dysfunction requiring supportive technologies during the convalescent phase of critical illness and it is present when a patient has an ongoing requirement for vasopressors, dialysis, or mechanical ventilation at the outcome assessments time points. In 600 patients enrolled in a randomized trial of nutrition therapy and followed prospectively for six months, we evaluated the prevalence of POD and its association with outcome. RESULTS: At 28 days, 2.3% of patients had circulatory failure, 13.7% had renal failure, 8.7% had respiratory failure, and 27.2% had died, for an overall prevalence of POD + death = 46.0%. Of survivors at Day 28, those with POD, compared to those without POD, had a higher mortality rate in the six-month follow-up period, had longer ICU and hospital stays, and a reduced quality of life at three months. Given these rates of POD + death and using a two-sided Chi-squared test at alpha = 0.05, we would require 616 patients per arm to detect a 25% relative risk reduction (RRR) in mortality, but only 286 per arm to detect the same RRR in POD + mortality. CONCLUSIONS: POD + death may be a valid composite outcome measure and compared to mortality endpoints, may reduce the sample size requirements of clinical trials of critically ill patients. Further validation in larger clinical trials is required.

Evaluation of standard and modified severity of illness scores in the obstetric patient.

PURPOSE: To test discrimination and calibration of APACHE-II and SAPS-II risk prediction scores in a cohort of obstetric patients, and to evaluate the effect of modifying these scores for the physiological changes in pregnancy. MATERIALS AND METHODS: A retrospective review of obstetric patients, 12 weeks gestation to 48 hours postpartum, admitted to the ICU for more than 24 hours. APACHE-II and SAPS-II, and versions modified for the physiological changes of pregnancy, were evaluated by receiver operating characteristic (ROC) curves and standardized mortality ratios (SMR). Multivariable analysis identified other parameters associated with mortality. RESULTS: Data were obtained from 332 patients from 5 countries, with a mortality rate of 12%. Mean (± SD) APACHE-II score was 16.8 ± 6.1 and SAPS-II score 26.5 ± 15.8. Good discrimination was demonstrated with area under the ROC curves of 0.82 and 0.78 respectively, with no improvement after modification for altered maternal physiology. APACHE-II overestimated mortality, with an SMR of 0.43 (0.52 after including diagnostic weighting) compared with 0.89 for SAPS-II. Bilirubin, albumin and Glasgow Coma Scale were independently associated with mortality. CONCLUSION: APACHE-II and SAPS-II are good discriminators of illness severity and may be valuable for comparing obstetric cohorts, but APACHE-II significantly over-estimates mortality.