Plasma angiotensin peptides as biomarkers of rheumatoid arthritis are correlated with anti-ACE2 auto-antibodies level and disease intensity.

BACKGROUND: This study aimed to explore a correlation between plasma angiotensin II/(1-7) (Ang II/Ang-(1-7)) ratio, anti-ACE2 autoantibodies level and disease activity in rheumatoid arthritis (RA) patients. METHODS: In a pilot study, the plasma level of Ang II, Ang-(1-7), and anti-ACE2 autoantibodies of twelve RA patients (five in active stage and seven in remission) were measured using an LC-MS/MS method and an ELISA kit, respectively. RESULTS: The Ang-(1-7) level was significantly higher in the remission group than in the active RA patients (7.63 ± 2.61 vs. 1.29 ± 0.81 ng/mL). On the contrary, the Ang II level was higher in those with active RA compared to the remission group (5.43 ± 1.82 vs. 0.87 ± 0.16 ng/mL). The mean ELISA score of anti-ACE2 autoantibodies in patients with active RA was significantly higher than patients in remission (1.41 ± 0.11 vs. 1.81 ± 0.11, p < 0.05). CONCLUSION: This study result suggests that the angiotensin peptides concentration and anti-ACE2 autoantibodies levels can be used as biomarkers of RA. This will help clinicians evaluate better treatment success rates and disease prognosis to prevent long-term complications of RA.

Design and Evaluation of the Electronic Patient-Generated Index.

BACKGROUND: The patient-generated index (PGI) is an individualized measure of health-related quality of life. Previous work testing the PGI in the oncology setting identified threats to content validity due to navigational and computational completion errors using the paper format. OBJECTIVE: The purpose of this pilot study was to refine and evaluate the usability and acceptability of an electronic PGI (ePGI) prototype in the outpatient radiation oncology setting. METHODS: This pilot study used adaptive agile web design, cognitive interview, and survey methods. RESULTS: Three iterations of testing and refining the ePGI were required. Fifteen patients completed the refined ePGI using touch screen tablets with little or no coaching required. Nearly all participants rated the ePGI as "easy" or "very" easy to use, understand, and navigate. Up to one half stated they did not share this type of information with their clinician but felt the information on the ePGI would be useful to discuss when making decisions about their care. Eight clinicians participated, all of whom felt the ePGI was a useful tool to initiate dialogue about quality of life issues, reveal infrequent or unusual effects of treatment, and assist with symptom management. DISCUSSION: The pilot study indicates the ePGI may be useful for use at the point of care. Larger studies are needed to explore the influence it may have in decision-making and restructuring patient/provider communication.

Context Matters for Nurses Leading Pain Improvement in U.S. Hospitals.

BACKGROUND: Pain continues to be a problem in hospitalized patients. Contextual factors contribute to the success of pain quality improvement efforts. AIMS: This paper describes nurse team leaders' perceptions of organizational context and factors perceived to help and hinder the process of leading a unit-based improvement effort focused on pain. DESIGN: Qualitative descriptive design. SETTING: Interviews took place over the telephone. PARTICIPANTS: Nurses from 106 hospitals across the United States. METHODS: Investigators interviewed 125 nurses leading a unit-based pain quality improvement project in partnership with the National Database of Nursing Quality Indicators. Lewin's Field Theory guided a thematic analysis. RESULTS: Key contextual factors related to the amount of change in the health care environment and characteristics of the organization and providers. Helping forces included characteristics of nurses, teamwork, a culture of quality, opportunities for learning, pain management resources, and accountability for pain management. Hindering forces included: barriers to involvement, attitudes and relationships, lack of knowledge, and types of patients. CONCLUSIONS: Overcoming the pervasive barriers of constant change and lack of staff involvement while also capitalizing on the culture of quality and characteristics of the health care team may further enhance and sustain improvement efforts related to pain management of hospitalized patients. New models for influencing quality improvement could be strengthened with involving frontline staff in both planning and implementation of improvement efforts. CLINICAL IMPLICATIONS: Because of the diverse responses, it is recommended that each unit conduct a force-field analysis to guide successful implementation of improvement efforts.

Diffusion of a Distress Management Guideline into practice.

OBJECTIVE: The purpose of this study was to explore system and clinician-related barriers, and predictors for the adoption of the National Comprehensive Cancer Network Distress Management Guideline (DMG) into oncology outpatient practice. METHODS: This descriptive, correlational study surveyed a national sample of oncology nurses working in an outpatient setting who completed the survey electronically or by mail. RESULTS: Study respondents (n = 409) were predominantly certified nurses (84%) yet largely unfamiliar with the DMG; 17% of respondents were using the DMG. Time, staff uncertainties and ambiguous accountability were the largest barriers to not assessing distress. Compared with those not using any assessment tool, those using the DMG were more comfortable discussing distress, worked as an oncology nurse longer, scored colleagues higher on valuing distress screening and had more organizational processes in place to support evidence-based practices. Significant predictors of DMG use included higher familiarity with the DMG (OR 3.81, p < .001), lower perceived barriers (OR 0.41, p = .001), non-profit status (OR 3.93, p = .05) and urban or rural (versus suburban) work settings (OR 04.59, p = .04; overall model chi-square 133.25, df 12, p < .001, Nagelkerke R(2) .67). CONCLUSIONS: This study identified barriers and predictors to using the DMG, which are amenable to interventions. DMG adoption may be augmented by interventions, which increase familiarity with the guideline. Additionally, adoption of the DMG may improve through explicit articulation of the responsibilities oncology team members have in cancer-related distress screening and management. Further studies are needed to evaluate the efficacy of such interventions and their impact on patient care outcomes.

Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I.

BACKGROUND: An important issue for patients with cancer treated with novel therapeutics is how they weigh the effects of treatment on survival and quality of life (QOL). We compared QOL in patients enrolled to SWOG S1400I, a substudy of the LungMAP biomarker-driven master protocol. METHODS: SWOG S1400I was a randomized phase III trial comparing nivolumab plus ipilimumab vs nivolumab for treatment of immunotherapy-naïve disease in advanced squamous cell lung cancer. The primary endpoint was the MD Anderson Symptom Inventory-Lung Cancer severity score at week 7 and week 13 with a target difference of 1.0 points, assessed using multivariable linear regression. A composite risk model for progression-free and overall survival was derived using best-subset selection. RESULTS: Among 158 evaluable patients, median age was 67.6 years and most were male (66.5%). The adjusted MD Anderson Symptom Inventory-Lung Cancer severity score was 0.04 points (95% confidence interval [CI] = -0.44 to 0.51 points; P = .89) at week 7 and 0.12 points (95% CI = -0.41 to 0.65; P = .66) at week 13. A composite risk model showed that patients with high levels of appetite loss and shortness of breath had a threefold increased risk of progression or death (hazard ratio [HR] = 3.06, 95% CI = 1.88 to 4.98; P < .001) and that those with high levels of both appetite loss and work limitations had a fivefold increased risk of death (HR = 5.60, 95% CI = 3.27 to 9.57; P < .001)-compared with those with neither risk category. CONCLUSIONS: We found no evidence of a benefit of ipilimumab added to nivolumab compared with nivolumab alone for QOL in S1400I. A risk model identified patients at high risk of poor survival, demonstrating the prognostic relevance of baseline patient-reported outcomes even in those with previously treated advanced cancer.

Assessing content validity of the patient generated index using cognitive interviews.

The effects of cancer and its treatment on quality of life contribute to patient and clinician decisions. Health-related quality of life (HRQL) is a subjective concept, leading to variation in its definition. This presents challenges when measuring HRQL and evaluating interventions. The designers of the Patient Generated Index (PGI) addressed these challenges by having individuals identify areas of their lives affected by illness and treatment, then report on these self-defined areas. We used cognitive interviews to collect information about patient understanding of the PGI, the response processes used to complete the PGI, and how well the PGI reflected participant HRQL. Interview data support the content validity of the PGI in comprehensively defining and adequately sampling participant HRQL as an individualized construct. Findings also support our recommendation to revise PGI formatting to reduce response errors. We make recommendations to reduce the cognitive demands the PGI places on respondents.

Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer: The Lung-MAP S1400I Phase 3 Randomized Clinical Trial.

IMPORTANCE: Nivolumab plus ipilimumab is superior to platinum-based chemotherapy in treatment-naive advanced non-small cell lung cancer (NSCLC). Nivolumab is superior to docetaxel in advanced pretreated NSCLC. OBJECTIVE: To determine whether the addition of ipilimumab to nivolumab improves survival in patients with advanced, pretreated, immunotherapy-naive squamous (Sq) NSCLC. DESIGN, SETTING, AND PARTICIPANTS: The Lung Cancer Master Protocol (Lung-MAP) S1400I phase 3, open-label randomized clinical trial was conducted from December 18, 2015, to April 23, 2018, randomizing patients in a 1:1 ratio to nivolumab alone or combined with ipilimumab. The median follow-up in surviving patients was 29.5 months. The trial was conducted through the National Clinical Trials Network and included patients with advanced immunotherapy-naive SqNSCLC and a Zubrod score of 0 (asymptomatic) to 1 (symptomatic but completely ambulatory) with disease progression after standard platinum-based chemotherapy. Randomization was stratified by sex and number of prior therapies (1 vs 2 or more). Data were analyzed from May 3, 2018, to February 1, 2021. INTERVENTIONS: Nivolumab, 3 mg/kg intravenously every 2 weeks, with or without ipilimumab, 1 mg/kg intravenously every 6 weeks, until disease progression or intolerable toxic effects. MAIN OUTCOMES AND MEASURES: The primary end point was overall survival (OS). Secondary end points included investigator-assessed progression-free survival (IA-PFS) and response per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1. RESULTS: Of 275 enrolled patients, 252 (mean age, 67.5 years [range 41.8-90.3 years]; 169 men [67%]; 206 White patients [82%]) were deemed eligible (125 randomized to nivolumab/ipilimumab and 127 to nivolumab). The study was closed for futility at a planned interim analysis. Overall survival was not significantly different between the groups (hazard ratio [HR], 0.87; 95% CI, 0.66-1.16; P = .34). Median survival was 10 months (95% CI, 8.0-14.4 months) in the nivolumab/ipilimumab group and 11 months (95% CI, 8.6-13.7 months) in the nivolumab group. The IA-PFS HR was 0.80 (95% CI, 0.61-1.03; P = .09); median IA-PFS was 3.8 months (95% CI, 2.7-4.4 months) in the nivolumab/ipilimumab group and 2.9 months (95% CI, 1.8-4.0 months) in the nivolumab alone group. Response rates were 18% (95% CI, 12%-25%) with nivolumab/ipilimumab and 17% (95% CI, 10%-23%) with nivolumab. Median response duration was 28.4 months (95% CI, 4.9 months to not reached) with nivolumab/ipilimumab and 9.7 months with nivolumab (95% CI, 4.2-23.1 months). Grade 3 or higher treatment-related adverse events occurred in 49 of 124 patients (39.5%) who received nivolumab/ipilimumab and in 41 of 123 (33.3%) who received nivolumab alone. Toxic effects led to discontinuation in 31 of 124 patients (25%) on nivolumab/ipilimumab and in 19 of 123 (15%) on nivolumab. CONCLUSIONS AND RELEVANCE: In this phase 3 randomized clinical trial, ipilimumab added to nivolumab did not improve outcomes in patients with advanced, pretreated, immune checkpoint inhibitor-naive SqNSCLC. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02785952.

Cannabis Use and Bleomycin: An Overview and Case Study of Pulmonary Toxicity.

BACKGROUND: Legalization efforts in many states have heightened awareness of the medicinal uses of cannabis, and oncology nurses are more frequently caring for patients who have used or are using cannabis. Significant epidemiologic data on the prevalence of cannabis use in patients with cancer are not yet available, and not much is known about the effects of cannabis on cancer treatment. OBJECTIVES: This article describes the effects cannabis may have on the lungs, reviews indications for cannabis use in patients with cancer, and explores an atypical case of progressive pulmonary toxicity in a young patient with a history of Hodgkin lymphoma and cannabis use. METHODS: A review of the literature on cannabis-associated lung injury was conducted, with 32 articles selected for full review. FINDINGS: As cannabis use in cancer care continues to gain support, further research evaluating cannabis use in patients treated with bleomycin is warranted. In addition, the pros and cons of cannabis use must be fully evaluated and discussed with the patient with cancer prior to recommending its use.

Translating research on the distress thermometer into practice.

Distress is commonly experienced by people with cancer. The National Comprehensive Cancer Network (NCCN) developed a guideline for screening and managing distress in 1999 and has updated the guideline on an annual basis ever since. Using the five-phase framework for translational research, this article summarizes research findings related to the guideline and associated distress thermometer for each phase of translational research. The NCCN Distress Management Guideline is a useful tool to screen for and manage distress. However, additional research is needed, particularly in the areas of impact on outcomes of importance to patients.

Validity of the Patient Generated Index as a quality-of-life measure in radiation oncology.

PURPOSE/OBJECTIVES: To evaluate psychometric properties of an instrument designed to measure individualized health-related quality of life (HRQOL). DESIGN: Repeated measures of self-reported quality of life. SETTING: An outpatient radiation therapy department in the western part of the United States. SAMPLE: 86 adults with cancer receiving their first course of radiation therapy. METHODS: The Patient Generated Index (PGI), the National Comprehensive Cancer Network's Distress Thermometer (DT), and the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core-30 (QLQ-C30). MAIN RESEARCH VARIABLES: Convergent validity, responsiveness, sensitivity, and response shift. FINDINGS: PGI scores were inversely correlated with scores on the DT (r = -0.49, -0.55, -0.44; p < 0.001), as well as the role (r = 0.31, 0.4, 0.38; p < 0.01), emotional (r = 0.33, 0.41, 0.33; p < 0.01), social functioning (r = 0.27, 0.49, 0.42; p < 0.05), pain (r = -0.29, -0.39, -0.39; p < 0.01), and fatigue (r = -0.35, -0.25, -0.47; p < 0.05) QLQ-C30 subscales at all measurement times. The PGI was responsive to those reporting high or low DT scores (t = 4.42, 3.32, 2.9; p < 0.05). A small-to-moderate effect size was detected in those who had an increase (effect size = 0.51) or decrease (effect size = 0.38) in HRQOL over time. Participants reconceptualized HRQOL over time. CONCLUSIONS: Data supported the PGI as a valid measure of individualized HRQOL. IMPLICATIONS FOR NURSING: The PGI potentially provides a more patient-centered measure of HRQOL in patients with cancer. Additional testing is needed in larger, more diverse groups.

An evidence-based conceptual analysis of presence.

Presence is recognized as a quality and an intervention of nursing care. As technology replaces human touch, economic constraints decrease time spent with the patient and the demand for holistic care increases, the act and quality of presence gains significance. Presence is described as transformative to the patient care experience, having the potential to hinder or facilitate the healing process. This conceptual analysis utilizes an evidence-based approach of presence for use in theory development and concept measurement.