Search

Background: Anxiety and emotional distress have not been studied in large, diverse samples of patients with pulmonary nodules., Research Question: How common are anxiety and distress in patients with newly identified pulmonary nodules, and what factors are associated with these outcomes?, Study Design and Methods: This study surveyed participants in the Watch the Spot Trial, a large, pragmatic clinical trial of more vs less intensive strategies for radiographic surveillance of patients with small pulmonary nodules. The survey included validated instruments to measure patient-centered outcomes such as nodule-related emotional distress (Impact of Event Scale-Revised) and anxiety (Six-Item State Anxiety Inventory) 6 to 8 weeks following nodule identification. Mixed-effects models were used to compare outcomes between study arms following adjustment for potential confounders and clustering within enrollment site, while also examining a limited number of prespecified explanatory factors, including nodule size, mode of detection, type of ordering clinician, and lack of timely notification prior to contact by the study team., Results: The trial enrolled 34,699 patients; 2,049 individuals completed the baseline survey (5.9%). Respondents and nonrespondents had similar demographic and nodule characteristics, although more respondents were non-Hispanic and White. Impact of Event Scale-Revised scores indicated mild, moderate, or severe distress in 32.2%, 9.4%, and 7.2% of respondents, respectively, with no difference in scores between study arms. Following adjustment, greater emotional distress was associated with larger nodule size and lack of timely notification by a clinician; distress was also associated with younger age, female sex, ever smoking, Black race, and Hispanic ethnicity. Anxiety was associated with lack of timely notification, ever smoking, and female sex., Interpretation: Almost one-half of respondents experienced emotional distress 6 to 8 weeks following pulmonary nodule identification. Strategies are needed to mitigate the burden of distress, especially in younger, female, ever smoking, and minoritized patients, and those with larger nodules., Clinical Trial Registration: ClinicalTrials.gov; No.: NCT02623712; URL: www., Clinicaltrials: gov., Competing Interests: Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: C. G. S. is supported by resources from the VA Portland Health Care System; he is the Medical Director of the VA Portland Health Care System lung nodule surveillance system and does not receive additional remuneration for this role. He has a grant from the Oregon Health & Science UniversityKnight Cancer Institute to develop a nodule/lung cancer risk prediction model that includes working with a for-profit company, Optellum, Ltd. Neither he nor the Knight Cancer Institute receive remuneration for this collaboration. M. K. G. received research support through his institution from Medial EarlySign to develop machine learning models of lung cancer risk; royalties from UpToDate to coauthor topics on lung cancer diagnosis and staging; and nonemployee compensation from the American Thoracic Society to serve as Deputy Editor of the Annals of the American Thoracic Society, all outside of the completed work. None declared (B. C., L. Q., S. E. G., C. P. K., E. W., R. A. M., L. T. V., K. F., J. S., E. d. B., V. V. M., D. A. A., D. S. D., K. K., D. L. M., R. S. W., R. S-B.)., (Copyright © 2023 American College of Chest Physicians. All rights reserved.)

Background: Baricitinib and dexamethasone have randomised trials supporting their use for the treatment of patients with COVID-19. We assessed the combination of baricitinib plus remdesivir versus dexamethasone plus remdesivir in preventing progression to mechanical ventilation or death in hospitalised patients with COVID-19., Methods: In this randomised, double-blind, double placebo-controlled trial, patients were enrolled at 67 trial sites in the USA (60 sites), South Korea (two sites), Mexico (two sites), Singapore (two sites), and Japan (one site). Hospitalised adults (≥18 years) with COVID-19 who required supplemental oxygen administered by low-flow (≤15 L/min), high-flow (>15 L/min), or non-invasive mechanical ventilation modalities who met the study eligibility criteria (male or non-pregnant female adults ≥18 years old with laboratory-confirmed SARS-CoV-2 infection) were enrolled in the study. Patients were randomly assigned (1:1) to receive either baricitinib, remdesivir, and placebo, or dexamethasone, remdesivir, and placebo using a permuted block design. Randomisation was stratified by study site and baseline ordinal score at enrolment. All patients received remdesivir (≤10 days) and either baricitinib (or matching oral placebo) for a maximum of 14 days or dexamethasone (or matching intravenous placebo) for a maximum of 10 days. The primary outcome was the difference in mechanical ventilation-free survival by day 29 between the two treatment groups in the modified intention-to-treat population. Safety analyses were done in the as-treated population, comprising all participants who received one dose of the study drug. The trial is registered with ClinicalTrials.gov, NCT04640168., Findings: Between Dec 1, 2020, and April 13, 2021, 1047 patients were assessed for eligibility. 1010 patients were enrolled and randomly assigned, 516 (51%) to baricitinib plus remdesivir plus placebo and 494 (49%) to dexamethasone plus remdesivir plus placebo. The mean age of the patients was 58·3 years (SD 14·0) and 590 (58%) of 1010 patients were male. 588 (58%) of 1010 patients were White, 188 (19%) were Black, 70 (7%) were Asian, and 18 (2%) were American Indian or Alaska Native. 347 (34%) of 1010 patients were Hispanic or Latino. Mechanical ventilation-free survival by day 29 was similar between the study groups (Kaplan-Meier estimates of 87·0% [95% CI 83·7 to 89·6] in the baricitinib plus remdesivir plus placebo group and 87·6% [84·2 to 90·3] in the dexamethasone plus remdesivir plus placebo group; risk difference 0·6 [95% CI -3·6 to 4·8]; p=0·91). The odds ratio for improved status in the dexamethasone plus remdesivir plus placebo group compared with the baricitinib plus remdesivir plus placebo group was 1·01 (95% CI 0·80 to 1·27). At least one adverse event occurred in 149 (30%) of 503 patients in the baricitinib plus remdesivir plus placebo group and 179 (37%) of 482 patients in the dexamethasone plus remdesivir plus placebo group (risk difference 7·5% [1·6 to 13·3]; p=0·014). 21 (4%) of 503 patients in the baricitinib plus remdesivir plus placebo group had at least one treatment-related adverse event versus 49 (10%) of 482 patients in the dexamethasone plus remdesivir plus placebo group (risk difference 6·0% [2·8 to 9·3]; p=0·00041). Severe or life-threatening grade 3 or 4 adverse events occurred in 143 (28%) of 503 patients in the baricitinib plus remdesivir plus placebo group and 174 (36%) of 482 patients in the dexamethasone plus remdesivir plus placebo group (risk difference 7·7% [1·8 to 13·4]; p=0·012)., Interpretation: In hospitalised patients with COVID-19 requiring supplemental oxygen by low-flow, high-flow, or non-invasive ventilation, baricitinib plus remdesivir and dexamethasone plus remdesivir resulted in similar mechanical ventilation-free survival by day 29, but dexamethasone was associated with significantly more adverse events, treatment-related adverse events, and severe or life-threatening adverse events. A more individually tailored choice of immunomodulation now appears possible, where side-effect profile, ease of administration, cost, and patient comorbidities can all be considered., Funding: National Institute of Allergy and Infectious Diseases., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Functional impairment of interferon, a natural antiviral component of the immune system, is associated with the pathogenesis and severity of COVID-19. We aimed to compare the efficacy of interferon beta-1a in combination with remdesivir compared with remdesivir alone in hospitalised patients with COVID-19., Methods: We did a double-blind, randomised, placebo-controlled trial at 63 hospitals across five countries (Japan, Mexico, Singapore, South Korea, and the USA). Eligible patients were hospitalised adults (aged ≥18 years) with SARS-CoV-2 infection, as confirmed by a positive RT-PCR test, and who met one of the following criteria suggestive of lower respiratory tract infection: the presence of radiographic infiltrates on imaging, a peripheral oxygen saturation on room air of 94% or less, or requiring supplemental oxygen. Patients were excluded if they had either an alanine aminotransferase or an aspartate aminotransferase concentration more than five times the upper limit of normal; had impaired renal function; were allergic to the study product; were pregnant or breast feeding; were already on mechanical ventilation; or were anticipating discharge from the hospital or transfer to another hospital within 72 h of enrolment. Patients were randomly assigned (1:1) to receive intravenous remdesivir as a 200 mg loading dose on day 1 followed by a 100 mg maintenance dose administered daily for up to 9 days and up to four doses of either 44 μg interferon beta-1a (interferon beta-1a group plus remdesivir group) or placebo (placebo plus remdesivir group) administered subcutaneously every other day. Randomisation was stratified by study site and disease severity at enrolment. Patients, investigators, and site staff were masked to interferon beta-1a and placebo treatment; remdesivir treatment was given to all patients without masking. The primary outcome was time to recovery, defined as the first day that a patient attained a category 1, 2, or 3 score on the eight-category ordinal scale within 28 days, assessed in the modified intention-to-treat population, defined as all randomised patients who were classified according to actual clinical severity. Safety was assessed in the as-treated population, defined as all patients who received at least one dose of the assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04492475., Findings: Between Aug 5, 2020, and Nov 11, 2020, 969 patients were enrolled and randomly assigned to the interferon beta-1a plus remdesivir group (n=487) or to the placebo plus remdesivir group (n=482). The mean duration of symptoms before enrolment was 8·7 days (SD 4·4) in the interferon beta-1a plus remdesivir group and 8·5 days (SD 4·3) days in the placebo plus remdesivir group. Patients in both groups had a time to recovery of 5 days (95% CI not estimable) (rate ratio of interferon beta-1a plus remdesivir group vs placebo plus remdesivir 0·99 [95% CI 0·87-1·13]; p=0·88). The Kaplan-Meier estimate of mortality at 28 days was 5% (95% CI 3-7%) in the interferon beta-1a plus remdesivir group and 3% (2-6%) in the placebo plus remdesivir group (hazard ratio 1·33 [95% CI 0·69-2·55]; p=0·39). Patients who did not require high-flow oxygen at baseline were more likely to have at least one related adverse event in the interferon beta-1a plus remdesivir group (33 [7%] of 442 patients) than in the placebo plus remdesivir group (15 [3%] of 435). In patients who required high-flow oxygen at baseline, 24 (69%) of 35 had an adverse event and 21 (60%) had a serious adverse event in the interferon beta-1a plus remdesivir group compared with 13 (39%) of 33 who had an adverse event and eight (24%) who had a serious adverse event in the placebo plus remdesivir group., Interpretation: Interferon beta-1a plus remdesivir was not superior to remdesivir alone in hospitalised patients with COVID-19 pneumonia. Patients who required high-flow oxygen at baseline had worse outcomes after treatment with interferon beta-1a compared with those given placebo., Funding: The National Institute of Allergy and Infectious Diseases (USA)., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Multiple morbidity is the norm in advanced COPD and contributes to high symptom burden and worse outcomes., Research Question: Can distinct comorbidity profiles be identified and validated in a community-based sample of patients with COPD from a large integrated health care system using a standard, commonly used diagnostic code-based comorbidity index and downstream 2-year health care use data?, Study Design and Methods: In this retrospective cohort study, we used latent class analysis (LCA) to identify comorbidity profiles in a population-based sample of 91,453 patients with a COPD diagnosis between 2011 and 2015. We included specific comorbid conditions from the Charlson Comorbidity Index (CCI) and accounted for variation in underlying prevalence of different comorbidities across the three study sites. Sociodemographic, clinical, and health-care use data were obtained from electronic health records (EHRs). Multivariate logistic regression analysis was used to compare rates of acute and postacute care use by class., Results: The mean age was 71 ± 11 years, 55% of patients were women, 23% of patients were people of color, and 80% of patients were former or current smokers. LCA identified four distinct comorbidity profiles with progressively higher CCI scores: low morbidity (61%; 1.9 ± 1.4), metabolic renal (21%; 4.7 ± 1.8), cardiovascular (12%; 4.6 ± 1.9), and multimorbidity (7%; 7.5 ± 1.7). In multivariate models, during 2 years of follow-up, a significant, nonoverlapping increase was found in the odds of having any all-cause acute (hospitalizations, observation stays, and ED visits) and postacute care use across the comorbidity profiles., Interpretation: Distinct comorbidity profiles can be identified in patients with COPD using standard EHR-based diagnostic codes, and these profiles are associated with subsequent acute and postacute care use. Population-based risk stratification schemes for end-to-end, comprehensive COPD management should consider integrating comorbidity profiles such as those found in this study., (Copyright © 2021 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Purpose: The aim of this study was to examine radiologists' beliefs about existing guidelines for pulmonary nodule evaluation., Methods: A self-administered survey was developed to ascertain awareness of, agreement with, and adherence to published guidelines, including those from the Fleischner Society and the Lung CT Screening Reporting and Data System (Lung-RADS™). Surveys were distributed to 514 radiologists at 13 health care systems that are participating in a large, pragmatic trial of pulmonary nodule evaluation. Prespecified comparisons were made among groups defined by type of health system, years of experience, reader volume, and study arm., Results: The response rate was 26.3%. Respondents were most familiar with guidelines from Fleischner (94%) and Lung-RADS (71%). For both incidental and screening-detected nodules, self-reported adherence to preferred guidelines was very high (97% and 94%, respectively), and most respondents believed that the benefits of adherence outweigh the harms (81% and 74%, respectively). Underlying evidence was thought to be high in quality by 68% of respondents for screening-detected nodules and 41% for incidental nodules. Approximately 70% of respondents believed that the frequency of recommended follow-up was "just right" for both guidelines. Radiologists who practice in nonintegrated health care systems were more likely to believe that the evidence was high in quality (79.5% versus 57.1%) and that the benefits of adherence outweigh the harms (85.1% versus 67.5%). Low-volume readers had lower awareness and self-reported adherence than higher volume readers., Conclusions: Radiologists reported high levels of familiarity and agreement with and adherence to guidelines for pulmonary nodule evaluation, but many overestimated the quality of evidence in support of the recommendations., (Copyright © 2020 American College of Radiology. All rights reserved.)

Objectives: In a previous project aimed at informing patient-centered care for people with multiple chronic conditions, we performed highly stratified quantitative benefit-harm assessments for 2 top priority questions. In this current work, our goal was to describe the process and approaches we developed and to qualitatively glean important elements from it that address patient-centered care., Methods: We engaged patients, caregivers, clinicians, and guideline developers as stakeholder representatives throughout the process of the quantitative benefit-harm assessment and investigated whether the benefit-harm balance differed based on patient preferences and characteristics (stratification). We refined strategies to select the most applicable, valid, and precise evidence., Results: Two processes were important when assessing the balance of benefits and harms of interventions: (1) engaging stakeholders and (2) stratification by patient preferences and characteristics. Engaging patients and caregivers through focus groups, preference surveys, and as co-investigators provided value in prioritizing research questions, identifying relevant clinical outcomes, and clarifying the relative importance of these outcomes. Our strategies to select evidence for stratified benefit-harm assessments considered consistency across outcomes and subgroups. By quantitatively estimating the range in the benefit-harm balance resulting from true variation in preferences, we clarified whether the benefit-harm balance is preference sensitive., Conclusions: Our approaches for engaging patients and caregivers at all phases of the stratified quantitative benefit-harm assessments were feasible and revealed how sensitive the benefit-harm balance is to patient characteristics and individual preferences. Accordingly, this sensitivity can suggest to guideline developers when to tailor recommendations for specific patient subgroups or when to explicitly leave decision making to individual patients and their providers., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: The benefits and harms of diabetes treatments need to be carefully weighed in people with type II diabetes mellitus (DM) and multiple chronic conditions (MCCs). Our objective was to quantitatively assess the benefits and harms of the addition of basal insulin (insulin) vs. sulfonylurea (SU) to metformin in people with DM and MCCs., Study Design and Setting: Data inputs into the benefit-harms analysis included (1) baseline risks of patient-centered outcomes (death, myocardial infarction, stroke, severe hypoglycemia, diarrhea, nausea) from cohorts and trials; (2) treatment effects for the addition of insulin vs. SU from a network meta-analysis; and (3) patient preference survey for outcome weights. Statistical analysis calculated the probability that adding insulin has greater benefits than harms, when compared with an SU, overall and by prespecified subgroups., Results: Including the six outcomes, the probability of net benefit for insulin compared with SU was similar, across subgroups by age and diabetes duration (probability range, using conditional logit weights: 0.44-0.56). Adding patient preferences for treatment burden associated with insulin injections shifted the probability to favor SU over insulin (probability range, using conditional logit weights: 0.01-0.12)., Conclusion: In people with DM and MCCs, we demonstrated incomplete evidence to conclude if basal insulin or SU should be added in people with DM and MCCs on metformin alone. The benefit-harm balance was sensitive to treatment preferences, that is., perceived treatment burden, indicating the importance of shared-decision making in caring for people with MCCs who are at high risk for experiencing harms associated with diabetes management., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Inhaled therapies are the cornerstone of pharmacologic management for COPD. Each device requires a unique series of steps to be most effective, making appropriate instruction in inhaler technique a key part of the management of COPD., Objectives: Examine characteristics of patients and devices associated with poor technique among patients with COPD., Methods: Cross-sectional study of subjects with COPD using at least one of: metered dose inhaler, Advair Diskus, Spiriva Handihaler, identified from the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT) registry. Technique was assessed face-to-face using manufacturer-provided dummy inhalers, with standardized checklists for each device. We used logistic regression to model associations with poor inhaler technique, defined as an error in ≥20% of the steps, as a function of patient characteristics, with educational attainment the primary predictor., Results: 688 individuals meet eligibility criteria, 65.5% had poor technique for at least one device. In adjusted analyses, Black race was associated with poor technique (OR 3.25, 95%CI 1.86-5.67) while greater than high school education was associated with decreased odds of poor technique (OR 0.35, 95%CI 0.17-0.70 for trade school/some college, OR 0.25, 95%CI 0.11-0.61 for college or more, p ≤ 0.001 for test of linear trend). The percentage of errors varied between devices, with subjects making proportionally the most errors for MDIs., Conclusions: Poor inhaler technique is common among individuals with COPD, varies between devices, and is associated with race and educational attainment. Tailored educational interventions to teach inhaler technique should be part of the process of initiating and monitoring inhaled therapies., (Published by Elsevier Ltd.)

Background: COPD is a major cause of morbidity and mortality in the United States as well as throughout the rest of the world. An exacerbation of COPD (periodic escalations of symptoms of cough, dyspnea, and sputum production) is a major contributor to worsening lung function, impairment in quality of life, need for urgent care or hospitalization, and cost of care in COPD. Research conducted over the past decade has contributed much to our current understanding of the pathogenesis and treatment of COPD. Additionally, an evolving literature has accumulated about the prevention of acute exacerbations., Methods: In recognition of the importance of preventing exacerbations in patients with COPD, the American College of Chest Physicians (CHEST) and Canadian Thoracic Society (CTS) joint evidence-based guideline (AECOPD Guideline) was developed to provide a practical, clinically useful document to describe the current state of knowledge regarding the prevention of acute exacerbations according to major categories of prevention therapies. Three key clinical questions developed using the PICO (population, intervention, comparator, and outcome) format addressed the prevention of acute exacerbations of COPD: nonpharmacologic therapies, inhaled therapies, and oral therapies. We used recognized document evaluation tools to assess and choose the most appropriate studies and to extract meaningful data and grade the level of evidence to support the recommendations in each PICO question in a balanced and unbiased fashion., Results: The AECOPD Guideline is unique not only for its topic, the prevention of acute exacerbations of COPD, but also for the first-in-kind partnership between two of the largest thoracic societies in North America. The CHEST Guidelines Oversight Committee in partnership with the CTS COPD Clinical Assembly launched this project with the objective that a systematic review and critical evaluation of the published literature by clinical experts and researchers in the field of COPD would lead to a series of recommendations to assist clinicians in their management of the patient with COPD., Conclusions: This guideline is unique because it provides an up-to-date, rigorous, evidence-based analysis of current randomized controlled trial data regarding the prevention of COPD exacerbations.

The American Board of Internal Medicine Foundation's Choosing Wisely campaign aims to curb health-care costs and improve patient care by soliciting lists from medical societies of the top five tests or treatments in their specialty that are used too frequently and inappropriately. The American Thoracic Society (ATS) and American College of Chest Physicians created a joint task force, which produced a top five list for adult pulmonary medicine. Our top five recommendations, which were approved by the executive committees of the ATS and American College of Chest Physicians and published by Choosing Wisely in October 2013, are as follows: (1) Do not perform CT scan surveillance for evaluation of indeterminate pulmonary nodules at more frequent intervals or for a longer period of time than recommended by established guidelines; (2) do not routinely offer pharmacologic treatment with advanced vasoactive agents approved only for the management of pulmonary arterial hypertension to patients with pulmonary hypertension resulting from left heart disease or hypoxemic lung diseases (groups II or III pulmonary hypertension); (3) for patients recently discharged on supplemental home oxygen following hospitalization for an acute illness, do not renew the prescription without assessing the patient for ongoing hypoxemia; (4) do not perform chest CT angiography to evaluate for possible pulmonary embolism in patients with a low clinical probability and negative results of a highly sensitive D-dimer assay; (5) do not perform CT scan screening for lung cancer among patients at low risk for lung cancer. We hope pulmonologists will use these recommendations to stimulate frank discussions with patients about when these tests and treatments are indicated--and when they are not.

Purpose: An endobronchial valve developed for treatment of severe emphysema has characteristics favorable for bronchoscopic treatment of air leaks. We present the results of a consecutive case series treating complex alveolopleural fistula with valves., Description: Patients with air leaks that persisted after treatment gave consent and compassionate use approval was obtained. Bronchoscopy with balloon occlusion was used to identify the airways to be treated. IBV Valves (Spiration, Redmond, WA) were placed after airway measurement., Evaluation: During a 15-month period, 8 valve placement procedures were performed in 7 patients and all had improvement in the air leak. The median duration of air leakage was 4 weeks before and 1 day after treatment, with a mean of 4.5 days. Discharge within 2 to 3 days of the procedure occurred in 57% of the patients. A median of 3.5 valves (mode, 2.4) were used, and all valve removals were successful. There were no procedural or valve-related complications., Conclusions: Removable endobronchial valves appear to be a safe and effective intervention for prolonged air leaks., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

During the last decade, mounting evidence worldwide has heightened awareness that patients with diverse health conditions commonly do not receive recommended care despite the proliferation of clinical practice guidelines. This is a particular problem for patients with COPD, who only receive recommended care during 30% to 55% of encounters with providers. Considering that COPD is the fourth leading cause of death worldwide, failure to implement guideline-directed care represents a major concern for respiratory professional societies. For other health conditions, inadequacies of care have stimulated public and private agencies to increase provider accountability by linking the results of performance measures to various quality-improvement interventions. Despite limited evidence that these interventions improve care, widespread adoption of value-based reimbursement has occurred in the United States and United Kingdom, and the prominence of these strategies in health-care reform suggest future growth and the likely proliferation of the performance measures upon which they are based. Of note, relatively few performance measures exist for COPD as compared with other conditions that have less impact on global health. The lack of COPD measures diminishes public awareness of COPD, allows diversion of quality improvement resources toward other conditions with existing measures, and negatively impacts COPD care. Respiratory professional societies can play an important role in stimulating the development of valid COPD measures derived from COPD practice guidelines and coordinate future measures to avoid burdensome reporting requirements for physicians if COPD measures are developed by competing payers and agencies in a fragmented or non-patient-centered manner.

Background: This consensus statement was developed based on the understanding that patients with advanced lung or heart disease are not being treated consistently and effectively for relief of dyspnea., Methods: A panel of experts was convened. After a literature review, the panel developed 23 statements covering five domains that were considered relevant to the topic condition. Endorsement of these statements was assessed by levels of agreement or disagreement on a five-point Likert scale using two rounds of the Delphi method., Results: The panel defined the topic condition as "dyspnea that persists at rest or with minimal activity and is distressful despite optimal therapy of advanced lung or heart disease." The five domains were: measurement of patient-reported dyspnea, oxygen therapy, other therapies, opioid medications, and ethical issues. In the second round of the Delphi method, 34 of 56 individuals (61%) responded, and agreement of at least 70% was achieved for 20 of the 23 statements., Conclusions: For patients with advanced lung or heart disease, we suggest that: health-care professionals are ethically obligated to treat dyspnea, patients should be asked to rate the intensity of their breathlessness as part of a comprehensive care plan, opioids should be dosed and titrated for relief of dyspnea in the individual patient, both the patient and clinician should reassess whether specific treatments are serving the goal of palliating dyspnea without causing adverse effects, and it is important for clinicians to communicate about palliative and end-of-life care with their patients.

Patients with advanced cancer often do not receive high-quality pain and symptom management or support with coordination of care, communication, and decision making. Implementing quality indicators that are reflective of the scope of care, feasible to implement, and supported by evidence might help to identify areas and settings most in need of improvement. However, recent reviews and policy initiatives identified only a few indicators that met these criteria. To help advance quality indicator development and implementation in this area, we developed a conceptual framework based on previous related initiatives, updated reviews of end-of-life cancer quality indicators and relevant data sources, and expert input. The framework describes five steps for developing and assessing a quality indicator for end-of-life care, defining the 1) population of focus, 2) broad quality domains, 3) specific target areas, 4) steps of the care process, and 5) evaluation criteria for quality indicators. The defined population includes seriously or terminally ill cancer patients, who are unlikely to recover or stabilize, and their families. Domains include the structure and processes of care; the physical, psychiatric, psychosocial, spiritual, and cultural aspects of care; as well as the care of the imminently dying, ethical and legal issues, and the delivery of care. Evaluation criteria include importance; scientific acceptability, including validity, evidence to improve outcomes, reliability, responsiveness, and variability; usability; and feasibility, including ready data sources. By using this conceptual framework, indicator developers, researchers, and policymakers can refine and implement indicator sets to effectively evaluate and improve care at the end of life.

Pain in patients who are critically ill remains undertreated despite decades of research, guideline development and distribution, and intense educational efforts. By nature of their complex medical conditions, these patients present unique challenges to the delivery of optimal pain treatment. Outdated clinical practices and faulty systems, such as a formulary that allows dangerous prescriptions, present additional obstacles. A multidisciplinary and patient-centered continuous quality improvement process is essential to identifying barriers and implementing evidence-based solutions to the problem of undertreated pain in hospital ICUs. This article addresses barriers common to the ICU setting and presents a number of structured approaches that have been shown to be successful in improving pain treatment in patients who are critically ill.

In the ICU where critically ill patients receive aggressive life-sustaining interventions, suffering is common and death can be expected in up to 20% of patients. High-quality pain management is a part of optimal therapy and requires knowledge and skill in pharmacologic, behavioral, social, and communication strategies grounded in the holistic palliative care approach. This contemporary review article focuses on pain management within comprehensive palliative and end-of-life care. These key points emerge from the transdisciplinary review: (1) all ICU patients experience opportunities for discomfort and suffering regardless of prognosis or goals, thus palliative therapy is a requisite approach for every patient, of which pain management is a principal component; (2) for those dying in the ICU, an explicit shift in management to comfort-oriented care is often warranted and may be the most beneficial treatment the health-care team can offer; (3) communication and cultural sensitivity with the patient-family unit is a principal approach for optimizing palliative and pain management as part of comprehensive ICU care; (4) ethical and legal misconceptions about the escalation of opiates and other palliative therapies should not be barriers to appropriate care, provided the intention of treatment is alleviation of pain and suffering; (5) standardized instruments, performance measurement, and care delivery aids are effective strategies for decreasing variability and improving palliative care in the complex ICU setting; and (6) comprehensive palliative care should addresses family and caregiver stress associated with caring for critically ill patients and anticipated suffering and loss.

This article addresses conventional pharmacologic and nonpharmacologic treatment of pain in patients in ICUs. For the critically ill patient, opioids have been the mainstay of pain control. The optimal choice of opioid and dosing regimen for a specific patient varies depending on factors such as the pharmacokinetics and physicochemical characteristics of an opioid and the body's handling of the opioid, concomitant sedative regimen, potential or actual adverse drug events, and development of tolerance. The clinician must appreciate that favorable pharmacokinetic properties such as a short-elimination half-life do not necessarily translate into clinical advantages in the ICU setting. A variety of medications have been proposed as alternatives or adjuncts to the opioids for pain control that have unique considerations when contemplated for use in the critically ill patient. Most have been relatively unstudied in the ICU setting, and many have limitations with respect to availability of the GI route of administration in patients with questionable GI absorptive function. Nonpharmacologic, complementary therapies are low cost, easy to provide, and safe, and many clinicians can implement them with little difficulty or resources. However, the evidence base for their effectiveness is limited. At present, insufficient research evidence is available to support a broad implementation of nonpharmacologic therapies in ICUs.

Background: The Agency for Healthcare Research and Quality ranks prevention of venous thromboembolism (VTE) as a top priority for patient safety; however, no guidelines or population-based research exist to guide management for podiatric surgery patients. The objective of our study was to determine the incidence and risk factors for postprocedure VTE in podiatric surgery., Methods: A 5-year retrospective analysis of patients undergoing podiatric surgery in a large not-for-profit health maintenance organization serving > 485,000 members in the Pacific Northwest from 1999 to 2004., Results: We identified 16,804 surgical procedures in 7,264 patients and detected 22 symptomatic postprocedure VTEs. The overall incidence of postprocedure VTE was 0.30%. Three risk factors were significantly and independently associated with VTE in podiatric surgery: prior VTE (incidence, 4.6%; relative risk, 23.0; p < 0.001), use of hormone replacement therapy or oral contraceptives (incidence, 0.55%; relative risk, 4.2; p = 0.01), and obesity (incidence, 0.48%; relative risk, 3.0; p = 0.02)., Conclusions: We identified a low overall risk of VTE in podiatric surgery, suggesting that routine prophylaxis is not warranted. However, for patients with a history of VTE, periprocedure prophylaxis is suggested based on the level of risk. For podiatry surgery patients with two or more risk factors for VTE, periprocedure prophylaxis should be considered. Until a prospective study is completed testing recommendations, guidelines and care decisions for podiatric surgery patients will continue to be based on retrospective data, expert consensus, and clinical judgment.

Pain is a common and distressing symptom in ICU patients. Yet a major challenge exists in assessing and evaluating the pain. Although the patient's self-report of pain is the "gold standard" for pain assessment, other methods must be considered when patients are unable to self-report. Currently only two pain behavior instruments have been tested for their reliability, validity, and feasibility of use in ICUs: the pain behavior scale and the Critical-Care Pain Observation Tool. Other tools, albeit with less validity testing, include the pain assessment, intervention, and notation (PAIN) algorithm and a pain behaviors checklist. When established tools are insufficient to evaluate a patient's pain, alternative methods of augmenting a pain evaluation should be considered. These can include the completion of a pain risk profile, use of surrogates, or performance of an analgesic trial. Meticulous attention to the evaluation of a critically ill patient's pain provides the basis for selection of pain interventions and the subsequent assessment of the intervention's effectiveness.

Palliative care aims to improve the quality of life of patients and their families and reduce suffering from life-threatening illness. In assessing palliative care efficacy, researchers must consider a broad range of potential outcomes, including those experienced by the patient's family/caregivers, clinicians, and the health care system. The purpose of this article is to summarize the discussions and recommendations of an Outcomes Working Group convened to advance the palliative care research agenda, particularly in the context of randomized controlled trials. These recommendations address the conceptualization of palliative care outcomes, sources of outcomes data, application of outcome measures in clinical trials, and the methodological challenges to outcome measurement in palliative care populations. As other fields have developed and refined methodological approaches that address their particular research needs, palliative care researchers must do the same to answer important clinical questions in rigorous and credible ways.

Background: The extent to which patients with obstructive lung disease receive recommended processes of care is largely unknown. We assessed the quality of care delivered to a national sample of the US population., Methods: We extracted medical records for 2 prior years from consenting participants in a random telephone survey in 12 communities and measured the quality of care provided with 45 explicit, process-based quality indicators for asthma and COPD developed using the modified Delphi expert panel methodology. Multivariate logistic regression evaluated effects of patient demographics, insurance, and other characteristics on the quality of health care., Results: We identified 2,394 care events among 260 asthma participants and 1,664 events among 169 COPD participants. Overall, participants received 55.2% of recommended care for obstructive lung disease. Asthma patients received 53.5% of recommended care; routine management was better (66.9%) than exacerbation care (47.8%). COPD patients received 58.0% of recommended care but received better exacerbation care (60.4%) than routine care (46.1%). Variation was seen in mode of care with considerable deficits in documenting recommended aspects of medical history (41.4%) and use of diagnostic studies (40.1%). Modeling demonstrated modest variation between racial groups, geographic areas, insurance types, and other characteristics., Conclusions: Americans with obstructive lung disease received only 55% of recommended care. The deficits and variability in the quality of care for obstructive lung disease present ample opportunity for quality improvement. Future endeavors should assess reasons for low adherence to recommended processes of care and assess barriers in delivery of care.

Study Objectives: To explore the quality of the dying experience and associations to higher quality ratings for people who died in an ICU., Design: Retrospective study using medical record review and surveys of family members with the Quality of Dying and Death (QODD) instrument., Setting: Four ICUs affiliated with a university and a Veterans Affairs Medical Center., Participants: Ninety-four family members of 38 ICU decedents., Measurements and Results: We explored associations between components of the ICU experience and the overall rating of the quality of the dying experience. Overall, family members reported that symptoms were poorly controlled: pain under control most or all of the time in 47%, and breathing comfortably most or all of the time in 3% of patients. Families expressed a moderate and variable view of the quality of dying resulting in an overall ICU QODD score of 60 +/- 14 (on a scale of 0 to 100) [mean +/- SD]. Higher ICU QODD scores were associated with control of pain (r = 0.42, p = 0.009), control of events (r = 0.62, p < 0.001), a "preparation for death" aspect of the dying experience--feeling at peace with dying (r = 0.69, p < 0.001), and a "whole-person concern"--keeping one's dignity and self-respect (r = 0.50, p < 0.001)., Conclusions: After adjusting for symptom and personal care scores, certain whole-person and preparation-for-death aspects of the dying process, and not aggressiveness of end-of-life care, remained the most associated to quality ratings. While future research should explore the important predictors of quality of dying in the ICU, this study suggests that care at the end of life in the ICU include not only managing pain, but also supporting dignity, respect, and peace, and maximizing patient control.