Emotional Distress, Anxiety, and General Health Status in Patients With Newly Identified Small Pulmonary Nodules: Results From the Watch the Spot Trial.

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.

Neonatal Outcomes After Delivery in Water.

OBJECTIVE: To assess neonatal intensive care unit (NICU) admissions and neonatal outcomes after water birth or land birth in an alternative birthing center. METHODS: We conducted a prospective observational study of preselected low-risk parturients separated into three groups depending on their location for labor and delivery: land-land, water-land, and water-water. Delivery outcomes, labor length, maternal pain assessment, need for newborn resuscitation, and NICU admission and diagnoses were collected. The primary outcome was admission to the NICU. RESULTS: There were 2,077 total deliveries from April 2015 to December 2019, consisting of 458 land-land deliveries, 730 water-land deliveries, and 889 water-water deliveries. The rate of NICU admission was 2.8% (95% CI 1.5-4.8%) for land-land deliveries, 4.1% (2.8-5.8%) for water-land deliveries, and 2.0% (1.2-3.2%) for water-water deliveries. A post hoc power analysis revealed a 70% power to detect a 2.1% difference in NICU admissions between the water-land and water-water groups. CONCLUSION: In this cohort of low-risk pregnant women, births in water and on land were associated with similar rates of admission to the NICU.

Initiating Pharmacologic Treatment in Tobacco-Dependent Adults. An Official American Thoracic Society Clinical Practice Guideline.

Background: Current tobacco treatment guidelines have established the efficacy of available interventions, but they do not provide detailed guidance for common implementation questions frequently faced in the clinic. An evidence-based guideline was created that addresses several pharmacotherapy-initiation questions that routinely confront treatment teams.Methods: Individuals with diverse expertise related to smoking cessation were empaneled to prioritize questions and outcomes important to clinicians. An evidence-synthesis team conducted systematic reviews, which informed recommendations to answer the questions. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach was used to rate the certainty in the estimated effects and the strength of recommendations.Results: The guideline panel formulated five strong recommendations and two conditional recommendations regarding pharmacotherapy choices. Strong recommendations include using varenicline rather than a nicotine patch, using varenicline rather than bupropion, using varenicline rather than a nicotine patch in adults with a comorbid psychiatric condition, initiating varenicline in adults even if they are unready to quit, and using controller therapy for an extended treatment duration greater than 12 weeks. Conditional recommendations include combining a nicotine patch with varenicline rather than using varenicline alone and using varenicline rather than electronic cigarettes.Conclusions: Seven recommendations are provided, which represent simple practice changes that are likely to increase the effectiveness of tobacco-dependence pharmacotherapy.

Stakeholder Research Priorities for Smoking Cessation Interventions within Lung Cancer Screening Programs. An Official American Thoracic Society Research Statement.

RATIONALE: Smoking cessation counseling in conjunction with low-dose computed tomography (LDCT) lung cancer screening is recommended in multiple clinical practice guidelines. The best approach for integrating effective smoking cessation interventions within this setting is unknown. OBJECTIVES: To summarize evidence, identify research gaps, prioritize topics for future research, and propose standardized tools for use in conducting research on smoking cessation interventions within the LDCT lung cancer screening setting. METHODS: The American Thoracic Society convened a multistakeholder committee with expertise in tobacco dependence treatment and/or LDCT screening. During an in-person meeting, evidence was reviewed, research gaps were identified, and key questions were generated for each of three research domains: (1) target population to study; (2) adaptation, development, and testing of interventions; and (3) implementation of interventions with demonstrated efficacy. We also identified standardized measures for use in conducting this research. A larger stakeholder panel then ranked research questions by perceived importance in an online survey. Final prioritization was generated hierarchically on the basis of average rank assigned. RESULTS: There was little consensus on which questions within the population domain were of highest priority. Within the intervention domain, research to evaluate the effectiveness in the lung cancer screening setting of evidence-based smoking cessation interventions shown to be effective in other contexts was ranked highest. In the implementation domain, stakeholders prioritized understanding strategies to identify and overcome barriers to integrating smoking cessation in lung cancer screening settings. CONCLUSIONS: This statement offers an agenda to stimulate research surrounding the integration and implementation of smoking cessation interventions with LDCT lung cancer screening.

An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice.

RATIONALE: Annual low-radiation-dose computed tomography (LDCT) screening for lung cancer has been shown to reduce lung cancer mortality among high-risk individuals and is now recommended by multiple organizations. However, LDCT screening is complex, and implementation requires careful planning to ensure benefits outweigh harms. Little guidance has been provided for sites wishing to develop and implement lung cancer screening programs. OBJECTIVES: To promote successful implementation of comprehensive LDCT screening programs that are safe, effective, and sustainable. METHODS: The American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) convened a committee with expertise in lung cancer screening, pulmonary nodule evaluation, and implementation science. The committee reviewed the evidence from systematic reviews, clinical practice guidelines, surveys, and the experience of early-adopting LDCT screening programs and summarized potential strategies to implement LDCT screening programs successfully. MEASUREMENTS AND MAIN RESULTS: We address steps that sites should consider during the main three phases of developing an LDCT screening program: planning, implementation, and maintenance. We present multiple strategies to implement the nine core elements of comprehensive lung cancer screening programs enumerated in a recent ACCP/ATS statement, which will allow sites to select the strategy that best fits with their local context and workflow patterns. Although we do not comment on cost-effectiveness of LDCT screening, we outline the necessary costs associated with starting and sustaining a high-quality LDCT screening program. CONCLUSIONS: Following the strategies delineated in this policy statement may help sites to develop comprehensive LDCT screening programs that are safe and effective.