Embedding an Education Intervention about Shared Decision Making into an RCT: Ensuring competency and fidelity.

Objective: To describe the outcomes of training nephrology clinicians and clinical research participants, to use the Best Case/Worst Case Communication intervention, for discussions about dialysis initiation for patients with life-limiting illness, during a randomized clinical trial to ensure competency, fidelity to the intervention, and adherence to study protocols and the intervention throughout the trial. Methods: We enrolled 68 nephrologists at ten study sites and randomized them to receive training or wait-list control. We collected copies of completed graphic aids (component of the intervention), used with study-enrolled patients, to measure fidelity and adherence. Results: We trained 34 of 36 nephrologists to competence and 27 completed the entire program. We received 60 graphic aids for study-enrolled patients for a 73% return rate in the intervention arm. The intervention fidelity score for the graphic aid reflected completion of all elements throughout the study. Conclusion: We successfully taught the Best Case/Worst Case Communication intervention to clinicians as research participants within a randomized clinical trial. Innovation: Decisions about dialysis are an opportunity to discuss prognosis and uncertainty in relation to consideration of prolonged life supporting therapy. Our study reveals a strategy to evaluate adherence to a communication intervention in real time during a clinical study.

Innovations in Surgical Communication-Provide Your Opinion, Don't Hide It.

This Viewpoint discusses why surgeons should reveal their initial impressions about surgery so that they can move forward in a space of deliberation to consider whether their inclination makes sense for the patient.

Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure.

INTRODUCTION: Given the burdens of treatment and poor prognosis, older adults with kidney failure would benefit from improved decision making and palliative care to clarify goals, address symptoms, and reduce unwanted procedures. Best Case/Worst Case (BC/WC) is a communication tool that uses scenario planning to support patients' decision making. This article describes the protocol for a multisite, cluster randomised trial to test the effect of training nephrologists to use the BC/WC communication tool on patient receipt of palliative care, and quality of life and communication. METHODS AND ANALYSIS: We are enrolling attending nephrologists, at 10 study sites in the USA, who see outpatients with advanced chronic kidney disease considering dialysis. We aim to enrol 320 patients with an estimated glomerular filtration rate of ≤24 mL/min/1.73 m2 who are age 60 and older and have a predicted survival of 18 months or less. Nephrologists will be randomised in a 1:1 ratio to receive training to use the communication tool (intervention) at study initiation or after study completion (wait-list control). Patients in the intervention group will receive care from a nephrologist trained to use the BC/WC communication tool. Patients in the control group will receive usual care. Using chart review and surveys of patients and caregivers, we will test the efficacy of the BC/WC intervention with receipt of palliative care as the primary outcome. Secondary outcomes include intensity of treatment at the end of life, the effect of the intervention on quality of communication (QOC) between nephrologists and patients (using the QOC scale), the change in quality of life (using the Functional Assessment of Chronic Illness Therapy-Palliative Care scale) and receipt of dialysis. ETHICS AND DISSEMINATION: Approvals have been granted by the Institutional Review Board at the University of Wisconsin (ID: 2022-0193), with each study site ceding review to the primary IRB. All nephrologists will be consented and given a copy of the consent form. No patients or caregivers will be recruited or consented until their nephrology provider has chosen to participate in the study. Results will be disseminated via submission for publication in a peer-reviewed journal and at national meetings. TRIAL REGISTRATION NUMBER: NCT04466865.

Evaluation of Prescribing Patterns Following Surgical Procedures in Opioid Naïve Patients at a Veterans Affairs Teaching Hospital.

OBJECTIVES: To evaluate facility postoperative opioid prescribing patterns in comparison to published guidelines and adherence to opioid safety mandates. METHODS: This quality analysis was performed between November 2019 and March 2020. Patients were identified to have been opioid naïve prior to receiving a new opioid prescription postoperatively during the study period. Patient charts were reviewed, and patients were contacted to collect desired data. Statistical analysis was performed to evaluate distributions of morphine equivalent daily dose and opioid day supply prescribed across study subpopulations. RESULTS: Ninety-four of 100 prescriptions evaluated were determined to be within quantity or duration recommendations of the selected guideline. Statistical analysis found no significantly different distributions between the duration and quantity of opioid prescribed at discharge and patient-specific risk factors. Forty-eight patients did not use the entire quantity of the initial opioid prescription dispensed. Of those patients, 26 still had opioids within the home. Opioid risk review documentation was completed in 19 of 65 patients indicated for documentation. CONCLUSION: Most opioid prescriptions provided within the study period aligned with recommendations from author-selected guidelines. However, a review of risk prior to opioid prescribing frequently was not performed. The number of patients utilizing less than 50% of prescribed opioids, and few refills indicate that reductions in opioids prescribed would improve safety for both patients and the surrounding community without increasing the risk for the under-treatment of postoperative pain. Improved prescribing habits and patient safety will be targeted through provider education regarding risk review documentation in opioid naïve patients.

Association Between Marital Status and Racial Disparities in Esophageal Cancer Care.

PURPOSE: This study was designed to examine the impact of marital status on racial disparities in esophageal cancer care. PATIENTS AND METHODS: We performed a secondary analysis of data collected from the state cancer registry maintained by the Michigan Department of Health and Human Services. We identified patients with an esophageal cancer diagnosis between January 1, 2000, and December 31, 2013. χ2 test and logistics regression were used to analyze 6,809 patients who met our eligibility criteria. Statistical significance was defined as P ≤ .05. RESULTS: Approximately 88.4% of our patients were White and 11.6% were Black. A significantly higher number of White patients were married when compared with Blacks (62.9% v 31.8%, respectively; P < .0001). There was no significant difference in cancer staging between the 2 groups (P = .0671). Married Blacks had similar rates of esophagectomy, chemotherapy, and radiation as married Whites. Both single groups had lower rates of esophagectomy and chemotherapy than married Whites, but single Blacks were the least likely to undergo esophagectomy. Single patients were more likely to refuse treatment. CONCLUSION: Marital status differs significantly in Black and White patients with esophageal cancer and may help explain racial disparities in cancer care. Further research is needed to explore reasons for care underutilization in single patients and whether these differences translate into clinical outcomes.

Is Lactic Acidosis After Lung Transplantation Associated With Worse Outcomes?

BACKGROUND: Elevated lactate levels may be caused by increased production suggestive of tissue ischemia; however, they may also occur without evidence of ischemia, by catecholamine activation of beta receptors. The purpose of this study was to determine the factors associated with increased lactate levels during and after lung transplantation and to evaluate whether lactate levels were associated with increased time to extubation and postoperative complications. METHODS: This was a retrospective study of patients who underwent lung transplantation between January 2015 and May 2017 at the University of Michigan, Ann Arbor, MI. Multivariable linear regression was used to determine the factors associated with peak lactate levels and to find the associations between lactate levels and outcomes of nitric oxide time, intubation time, length of stay, and creatinine level. Logistic regression was used to determine the associations between lactate levels and acute kidney injury and atrial fibrillation. RESULTS: A total of 86 patients underwent single-lung transplantation (n = 17; 20%) or double-lung transplantation (n = 69; 80%). All patients initially had normal lactate levels. On univariate analysis, lactate levels at several time points were correlated with subsequent acute kidney injury, increased time to extubation, and increased nitric oxide time. After adjustment, the study found that higher peak intensive care unit lactate levels (regression coefficient B = 0.046; interquartile range, 0.006, 0.086; P = .025) were associated with longer length of stay. CONCLUSIONS: Cardiopulmonary bypass time, total ischemic time, and catecholamine use were associated with higher lactate levels, whereas nitric oxide and higher pulmonary artery pressures were associated with lower levels. Increased lactate levels were independently associated with longer intubation times, postoperative acute kidney injury, and longer length of stay.

Gender Disparity in Referral for Definitive Care of Malignant Pleural Effusions.

BACKGROUND: Gender disparities exist in cancer care. Malignant pleural effusions (MPEs) carry a poor prognosis and are managed by different physicians. This study sought to evaluate referral patterns and gender differences for definitive treatment and outcomes of MPE patients. MATERIALS AND METHODS: Patients diagnosed with MPE from 1999 to 2015 at a quaternary care hospital were retrospectively reviewed to obtain patient history, referral to thoracic surgery for definitive management, and outcomes. Analysis was performed using chi-squared/Fisher's exact test, logistic regression models, and multivariate analysis. RESULTS: 224/686 patients (32.7%) were referred to thoracic surgery. No survival difference existed between referral and nonreferral groups or referred patients who received or did not receive pleurodesis. 405 patients (59.0%) were women. Women were statistically significantly less likely to be referred than men (27.9% versus 39.5%, P = 0.0014). This disparity persisted when comorbidities were controlled for (P = 0.0004) and when gynecologic cancers (e.g., uterine, ovarian, but not including breast; 55 female patients) were excluded from analysis (28.9% versus 39.5%, P = 0.0049). Women had statistically significantly more thoracenteses (3.34 versus 2.19, P < 0.0001) and improved survival compared with males (median survival = 136 d versus 54; P = 0.0004). CONCLUSIONS: Gender disparity exists in referral patterns for definitive management of MPE; women are less likely to be referred than men. Women have longer survival and a greater number of thoracenteses performed, despite a lower referral rate for definitive care. Further research is needed to understand the differences in referral rates and outcomes between men and women.