Comparison of a Voluntary Safety Reporting System to a Global Trigger Tool for Identifying Adverse Events in an Oncology Population.

OBJECTIVE: There is a lack of research on adverse event (AE) detection in oncology patients, despite the propensity for iatrogenic harm. Two common methods include voluntary safety reporting (VSR) and chart review tools, such as the Institute for Healthcare Improvement's Global Trigger Tool (GTT). Our objective was to compare frequency and type of AEs detected by a modified GTT compared with VSR for identifying AEs in oncology patients in a larger clinical trial. METHODS: Patients across 6 oncology units (from July 1, 2013, through May 29, 2015) were randomly selected. Retrospective chart reviews were conducted by a team of nurses and physicians to identify AEs using the GTT. The VSR system was queried by the department of quality and safety of the hospital. Adverse event frequencies, type, and harm code for both methods were compared. RESULTS: The modified GTT detected 0.90 AEs per patient (79 AEs in 88 patients; 95% [0.71-1.12] AEs per patient) that were predominantly medication AEs (53/79); more than half of the AEs caused harm to the patients (41/79, 52%), but only one quarter were preventable (21/79; 27%). The VSR detected 0.24 AEs per patient (21 AEs in 88 patients; 95% [0.15-0.37] AEs per patient), a large plurality of which were medication/intravenous related (8/21); more than half did not cause harm (70%). Only 2% of the AEs (2/100) were detected by both methods. CONCLUSIONS: Neither the modified GTT nor the VSR system alone is sufficient for detecting AEs in oncology patient populations. Further studies exploring methods such as automated AE detection from electronic health records and leveraging patient-reported AEs are needed.

Serial Perioperative Assessment of Free Flap Perfusion With Laser Angiography.

STUDY DESIGN: Prospective cohort study. OBJECTIVE: Reconstruction with microvascular free flaps is quite predictable but excessive fluids intraoperatively and excessive use of vasopressors have been implicated in postoperative complications. However, vasopressors assist in limiting fluid administration and counteract vasodilatory effects of general anesthetics, while maintaining proper intravascular volume. This is of paramount importance during surgery to ensure adequate tissue and organ perfusion. The purpose of this study is to quantify perfusion changes in free flaps at specific time points during peri- and postoperative periods, incorporating SPY technology. METHODS: A prospective study of patients who underwent free flap reconstruction was conducted (n = 9), using SPY laser angiography with indocyanine green to assess effects of general anesthetics and vasopressors on flap perfusion. Free flaps were evaluated prior to pedicle division, after inset and anastomosis, and in the immediate postoperative setting. Mean perfusion, mean arterial pressure, total operative time, fluid shifts, and vasopressor use were recorded. Data were analyzed with univariate and multivariable analyses. RESULTS: Those with major complications in this cohort, on average received less vasopressors, had shorter operation times and less blood loss, however, they received more fluids intraoperatively. CONCLUSION: Changes in mean perfusion to the free flap during the intraoperative and immediate postoperative period are nominal.

Inflammatory Biomarker Trends Predict Respiratory Decline in COVID-19 Patients.

In this single-center, retrospective cohort analysis of hospitalized coronavirus disease 2019 (COVID-19) patients, we investigate whether inflammatory biomarker levels predict respiratory decline in patients who initially present with stable disease. Examination of C-reactive protein (CRP) trends reveals that a rapid rise in CRP levels precedes respiratory deterioration and intubation, although CRP levels plateau in patients who remain stable. Increasing CRP during the first 48 h of hospitalization is a better predictor (with higher sensitivity) of respiratory decline than initial CRP levels or ROX indices (a physiological score of respiratory function). CRP, the proinflammatory cytokine interleukin-6 (IL-6), and physiological measures of hypoxemic respiratory failure are correlated, which suggests a mechanistic link. Our work shows that rising CRP predicts subsequent respiratory deterioration in COVID-19 and may suggest mechanistic insight and a potential role for targeted immunomodulation in a subset of patients early during hospitalization.

Diagnosing sepsis is subjective and highly variable: a survey of intensivists using case vignettes.

BACKGROUND: Sepsis is the focus of national quality improvement programs and a recent public reporting measure from the Centers for Medicare and Medicaid Services. However, diagnosing sepsis requires interpreting nonspecific signs and can therefore be subjective. We sought to quantify interobserver variability in diagnosing sepsis. METHODS: We distributed five case vignettes of patients with suspected or confirmed infection and organ dysfunction to a sample of practicing intensivists. Respondents classified cases as systemic inflammatory response syndrome, sepsis, severe sepsis, septic shock, or none of the above. Interobserver variability was calculated using Fleiss' κ for the five-level classification, and for answers dichotomized as severe sepsis/septic shock versus not-severe sepsis/septic shock and any sepsis category (sepsis, severe sepsis, or septic shock) versus not-sepsis. RESULTS: Ninety-four physicians completed the survey. Most respondents (88%) identified as critical care specialists; other specialties included pulmonology (39%), anesthesia (19%), surgery (9%), and emergency medicine (9%). Respondents had been in practice for a median of 8 years, and 90% practiced at academic hospitals. Almost all respondents (83%) felt strongly or somewhat confident in their ability to apply the traditional consensus sepsis definitions. However, overall interrater agreement in sepsis diagnoses was poor (Fleiss' κ 0.29). When responses were dichotomized into severe sepsis/septic shock versus not-severe sepsis/septic shock or any sepsis category versus not-sepsis, agreement was still poor (Fleiss' κ 0.23 and 0.18, respectively). Seventeen percent of respondents classified one of the five cases as severe sepsis/septic shock, 27.7% rated two cases, 33.0% respondents rated three cases, 19.2% rated four cases, and 3.2% rated all five cases as severe sepsis/septic shock. Among respondents who felt strongly confident in their ability to use sepsis definitions (n = 45), agreement was no better (Fleiss' κ 0.28 for the five-category classification, and Fleiss' κ 0.21 for the dichotomized severe sepsis/septic shock classification). Cases were felt to be extremely or very realistic in 74% of responses; only 3% were deemed unrealistic. CONCLUSIONS: Diagnosing sepsis is extremely subjective and variable. Objective criteria and standardized methodology are needed to enhance consistency and comparability in sepsis research, surveillance, benchmarking, and reporting.

Participatory Design and Development of a Patient-centered Toolkit to Engage Hospitalized Patients and Care Partners in their Plan of Care.

Patient engagement has been identified as a key strategy for improving patient outcomes. In this paper, we describe the development and pilot testing of a web-based patient centered toolkit (PCTK) prototype to improve access to health information and to engage hospitalized patients and caregivers in the plan of care. Individual and group interviews were used to identify plan of care functional and workflow requirements and user interface design enhancements. Qualitative methods within a participatory design approach supported the development of a PCTK prototype that will be implemented on intensive care and oncology units to engage patients and professional care team members developing their plan of care during an acute hospitalization.

Influence of patients' preferences and treatment site on cancer patients' end-of-life care.

BACKGROUND: Research suggests that patients' end-of-life (EOL) care is determined primarily by the medical resources available, and not by patient preferences. The authors examined whether patients' desire for life-extending therapy was associated with their EOL care. METHODS: Coping with Cancer is a multisite, prospective, longitudinal study of patients with advanced cancer. Three hundred one patients were interviewed at baseline and followed until death, a median of 4.5 months later. Multivariate analyses examined the influence of patients' preferences and treatment site on whether patients received intensive care or hospice services in the final week of life. RESULTS: Eighty-three of 301 patients (27.6%) with advanced cancer wanted life-extending therapy at baseline. Patients who understood that their disease was terminal or who reported having EOL discussions with their physicians were less likely to want life-extending care compared with others (23.4% vs 42.6% and 20.7% vs 44.4%, respectively; P≤.003). Patients who were treated at Yale Cancer Center received more intensive care (odds ratio [OR], 3.14; 95% confidence interval [CI], 1.16-8.47) and less hospice services (OR, 0.52; 95% CI, 0.29-0.92) compared with patients who were treated at Parkland Hospital. However, in multivariate analyses that controlled for confounding influences, patients who preferred life-extending care were more likely to receive intensive care (adjusted OR [AOR], 2.91; 95% CI, 1.09-7.72) and were less likely to receive hospice services (AOR, 0.45; 95% CI, 0.26-0.78). Treatment site was not identified as a significant predictor of EOL care. CONCLUSIONS: The treatment preferences of patients with advanced cancer may play a more important role in determining the intensity of medical care received at the EOL than previously recognized. Future research is needed to determine the mechanisms by which patients' preferences for care and treatment site interact to influence EOL care.

Exhaled nitric oxide: a marker of pulmonary hemodynamics in heart failure.

OBJECTIVES: We sought to test the hypothesis that patients with decompensated heart failure (HF) lose a compensatory process whereby nitric oxide (NO) maintains pulmonary vascular tone. BACKGROUND: Exhaled nitric oxide (eNO) partially reflects vascular endothelial NO release. Levels of eNO are elevated in patients with compensated HF and correlate inversely with pulmonary artery pressures (PAP), reflecting pulmonary vasodilatory activity. METHODS: We measured the mean mixed expired NO content of a vital-capacity breath using chemiluminescence in patients with compensated HF (n = 30), decompensated HF (n = 7) and in normal control subjects (n = 90). Pulmonary artery pressures were also measured in patients with HF. The eNO and PAP were determined sequentially during therapy with intravenous vasodilators in patients with decompensated HF (n = 7) and in an additional group of patients with HF (n = 13) before and during administration of milrinone. RESULTS: The eNO was higher in patients with HF than in control subjects (9.9 +/- 1.1 ppb vs. 6.2 +/- 0.4 ppb, p = 0.002) and inversely correlated with PAP (r = -0.81, p < 0.00001). In marked contrast, patients with decompensated HF exhibited even higher levels of eNO (20.4 +/- 6.2 ppb) and PAP, but there was a loss of the inverse relationship between these two variables. During therapy (7.3 +/- 6 days) with sodium nitroprusside and diuresis, hemodynamics improved, eNO concentrations fell (11.2 +/- 1.2 ppb vs. before treatment, p < 0.05), and the relationship between eNO and PAP was restored. After milrinone, eNO rose proportionally with decreased PAP (p < 0.05). CONCLUSIONS: Elevated eNO may reflect a compensatory circulatory mechanism in HF that is lost in patients with clinically decompensated HF. The eNO may be an easily obtainable and quantifiable measure of the response to therapy in advanced HF.