Challenges Addressing Lung Cancer Screening for Patients With Multimorbidity in Primary Care: A Qualitative Study.

PURPOSE: Many individuals who are eligible for lung cancer screening have comorbid conditions complicating their shared decision-making conversations with physicians. The goal of our study was to better understand how primary care physicians (PCPs) factor comorbidities into their evaluation of the risks and benefits of lung cancer screening and into their shared decision-making conversations with patients. METHODS: We conducted semistructured interviews by videoconference with 15 PCPs to assess the extent of shared decision-making practices and explore their understanding of the intersection of comorbidities and lung cancer screening, and how that understanding informed their clinical approach to this population. RESULTS: We identified 3 themes. The first theme was whether to discuss or not to discuss lung cancer screening. PCPs described taking additional steps for individuals with complex comorbidities to decide whether to initiate this discussion and used subjective clinical judgment to decide whether the conversation would be productive and beneficial. PCPs made mental assessments that factored in the patient's health, life expectancy, quality of life, and access to support systems. The second theme was that shared decision making is not a simple discussion. When PCPs did initiate discussions about lung cancer screening, although some believed they could provide objective information, others struggled with personal biases. The third theme was that ultimately, the decision to be screened was up to the patient. Patients had the final say, even if their decision was discordant with the PCP's advice. CONCLUSIONS: Shared decision-making conversations about lung cancer screening differed substantially from the standard for patients with complex comorbidities. Future research should include efforts to characterize the risks and benefits of LCS in patients with comorbidities to inform guidelines and clinical application.

Adverse Events Following Limited Resection versus Stereotactic Body Radiation Therapy for Early Stage Lung Cancer.

Rationale: Approximately a quarter of patients with early stage lung cancer are not medically fit for lobectomy. Limited resection and stereotactic body radiation therapy (SBRT) have emerged as alternatives for these patients. Given the equipoise on the effectiveness of the two treatments, treatment-related adverse events (AEs) could have a significant impact on patients' decision-making and treatment outcomes. Objectives: To compare the AE profile between SBRT versus limited resection. Methods: Data were derived from a prospective cohort of patients with stage I-IIA non-small cell lung cancer who were deemed as high-risk for lobectomy recruited from five centers across the United States. Propensity scores and inverse probability weighting were used to compare the rates of 30- and 90-day AEs among patients treated with limited resection versus SBRT. Results: Overall, 65% of 252 patients underwent SBRT. After adjusting for propensity scores, there was no significant difference in developing at least one AE comparing SBRT to limited resection (odds ratio [OR]: 1.00; 95% confidence interval [CI]: 0.65-1.55 and OR: 1.27; 95% CI: 0.84-1.91 at 30 and 90 days, respectively). SBRT was associated with lower risk of infectious AEs than limited resection at 30 days (OR: 0.05; 95% CI: 0.01-0.39) and 90 days posttreatment (OR: 0.41; 95% CI: 0.17-0.98). Additionally, SBRT was associated with persistently elevated risk of fatigue (OR: 2.47; 95% CI: 1.34-4.54 at 30 days and OR: 2.69; 95% CI: 1.52-4.77 at 90 days, respectively), but significantly lower risks of respiratory AEs (OR: 0.36; 95% CI: 0.20-0.65 and OR: 0.51; 95% CI: 0.31-0.86 at 30 and 90 days, respectively). Conclusions: Though equivalent in developing at least one AE, we found that SBRT is associated with less toxicity than limited resection in terms of infectious and respiratory AEs but higher rates of fatigue that persisted up to 3 months posttreatment. This information, combined with data about oncologic effectiveness, can help patients' decision-making regarding these alternative therapies.

Concordance of patients' beliefs about chronic obstructive pulmonary disease, their comorbidities, and their medications.

OBJECTIVE: To test the association of chronic obstructive pulmonary disease (COPD) illness and medication beliefs with those specific to hypertension or diabetes in patients with COPD and coexisting chronic conditions. METHODS: A cross-sectional analysis of data collected from a sample of 282 adults with COPD and comorbid hypertension or diabetes recruited from primary care practices in New York, NY, and Chicago, IL. Beliefs about COPD, hypertension, and diabetes were measured using the Brief Illness Perception Questionnaire. Higher scores indicate a more adaptive view of the illness. Beliefs about medications were measured using the 10-item Beliefs about Medicines Questionnaire; higher scores on the two subscales indicate increased concerns and necessity, respectively. RESULTS: In adjusted analyses, scores for COPD and hypertension as well as COPD and diabetes illness beliefs, medication necessity, and medication concern were significantly associated. CONCLUSION: Patients with COPD and comorbid hypertension or diabetes have consistent beliefs about their diseases and the medications used to treat them. PRACTICE IMPLICATIONS: The consistency of beliefs across conditions may help in the development of a more holistic approach to disease management in patients with COPD who have comorbid illnesses and contribute to a better understanding of the Common-Sense Model of Illness Representation.

Beliefs and attitudes about lung cancer screening among smokers.

The National Lung Screening Trial (NLST) recently reported that annual computed tomography (CT) screening is associated with decreased lung cancer mortality in high-risk smokers. Beliefs about lung cancer and screening, particularly across race and ethnicity, and their influence on CT screening utilization are largely unexamined. Our study recruited asymptomatic, high-risk smokers, 55-74 years of age from primary care clinics in an academic urban hospital. Guided by the self-regulation theory, we evaluated cognitive and affective beliefs about lung cancer. Intention to screen for lung cancer with a CT scan was assessed by self-report. We used univariate and logistic regression analyses to compare beliefs about screening and intention to screen among minority (Blacks and Hispanics) and non-minority participants. Overall, we enrolled 108 participants, of which 40% were Black and 34% were Hispanic; the mean age was 62.3 years, and median pack-years of smoking was 26. We found that intention to screen was similar among minorities and non-minorities (p=0.19); however, Hispanics were less likely to report intention to screen if they had to pay for the test (p=0.02). Fatalistic beliefs, fear of radiation exposure, and anxiety related to CT scans were significantly associated with decreased intention to screen (p<0.05). Several differences were observed in minority versus non-minority participants' beliefs toward lung cancer and screening. In conclusion, we found that concerns about cost, which were particularly prominent among Hispanics, as well as fatalism and radiation exposure fears may constitute barriers to lung cancer screening. Lung cancer screening programs should address these factors to ensure broad participation, particularly among minorities.

Survival and risk of adverse events in older patients receiving postoperative adjuvant chemotherapy for resected stages II-IIIA lung cancer: observational cohort study.

OBJECTIVE: To compare the survival and risk of serious adverse events in older patients with stages II-IIIA non-small cell lung cancer treated with or without postoperative platinum based chemotherapy. DESIGN: Observational cohort study. SETTING: Cases of lung cancer in Surveillance Epidemiology and End Results registry linked to Medicare files, 1992-2005, and follow-up data to December 2007. PARTICIPANTS: 3324 patients aged more than 65 years with resected stages II-IIIA lung cancer. MAIN OUTCOME MEASURES: Primary outcome was overall survival and secondary outcome was the rate of serious adverse events among older patients treated with or without adjuvant chemotherapy. RESULTS: Overall, 21% (n = 684) of patients received platinum based chemotherapy. Analyses adjusted, stratified, or matched by propensity scores showed that chemotherapy was associated with improved survival (hazard ratio range 0.78-0.81). The beneficial effect of chemotherapy was also observed among patients treated with radiation therapy (0.75-0.77) or without radiation therapy (0.74-0.77); however, chemotherapy was not beneficial for patients aged 80 or more (1.32-1.46). Adjuvant chemotherapy was associated with an increased odds of serious adverse events (odds ratio 2.0, 95% confidence interval 1.5 to 2.6). CONCLUSIONS: Platinum based adjuvant chemotherapy is associated with reduced mortality and increased risk of serious adverse events in older patients with stages II-IIIA lung cancer. The magnitude of the benefit is similar to that observed in randomised controlled trials carried out among selected patients.

Primary prevention of sudden cardiac death in silent cardiac sarcoidosis: role of programmed ventricular stimulation.

BACKGROUND: Cardiac involvement in sarcoidosis is often silent and may lead to sudden death. This study was designed to assess the value of programmed electric stimulation of the ventricle (PES) for risk stratification in patients with sarcoidosis and evidence of preclinical cardiac involvement on imaging studies. METHODS AND RESULTS: Patients with biopsy-proven systemic sarcoidosis but without cardiac symptoms who had evidence of cardiac sarcoidosis on positron emission tomography (PET) or cardiac MRI (CMR) were included. All patients underwent baseline evaluation, echocardiographic assessment of left ventricular function, and programmed electric stimulation of the ventricle. Patients were followed for survival and arrhythmic events. Seventy-six patients underwent PES of the ventricle. Eight (11%) were inducible for sustained ventricular arrhythmias and received an implantable defibrillator. None of the noninducible patients received a defibrillator. Left ventricular ejection fraction was lower in patients with inducible ventricular arrhythmia (36.4±4.2% versus 55.8±1.5%, P<0.05). Over a median follow-up of 5 years, 6 of 8 patients in the group with inducible ventricular arrhythmias had ventricular arrhythmia or died, compared with 1 death in the negative group (P<0.0001). CONCLUSIONS: In patients with biopsy-proven sarcoidosis and evidence of cardiac involvement on PET or CMR alone, positive PES may help to identify patients at risk for ventricular arrhythmia. More importantly, patients in this cohort with a negative PES appear to have a benign course within the first several years following diagnosis. PES may help to guide the use of implantable cardioverter defibrillators in this population.

Use of herbal remedies and adherence to inhaled corticosteroids among inner-city asthmatic patients.

BACKGROUND: Complementary and alternative medicines (CAM), such as herbal remedies, are widely used by patients with chronic diseases, such as asthma. However, it is unclear whether use of the herbal remedies is associated with decreased adherence to inhaled corticosteroids (ICSs), a key component of asthma management. OBJECTIVE: To examine the association among use of herbal remedies, adherence to prescribed ICSs, and medication and disease beliefs. METHODS: We surveyed 326 adults with persistent asthma who received care at 2 inner-city outpatient clinics. Patients were asked about CAM use (teas, herbs, and rubs) for the treatment of asthma in the prior 6 months. Medication adherence was assessed using the Medication Adherence Report Scale, a validated self-report measure. Univariate and multiple regression analyses were used to assess the relationship among herbal remedy use, adherence to ICSs, and medication and disease beliefs. RESULTS: Overall, 25.4% (95% confidence interval, 20%-30%) of patients reported herbal remedy use. Univariate analyses showed that herbal remedy use was associated with decreased ICS adherence and increased asthma morbidity. In multivariable analysis, herbal remedy use was associated with lower ICS adherence (odds ratio, 0.4; 95% confidence interval, 0.2-0.8) after adjusting for confounders. Herbal remedy users were also more likely to worry about the adverse effects of ICSs (P = .01). CONCLUSIONS: The use of herbal remedies was associated with lower adherence to ICSs and worse outcomes among inner-city asthmatic patients. Medication beliefs, such as worry about ICS adverse effects, may in part mediate this relationship. Physicians should routinely ask patients with asthma about CAM use, especially those whose asthma is poorly controlled.

Safety and tolerability of an antiasthma herbal Formula (ASHMI) in adult subjects with asthma: a randomized, double-blinded, placebo-controlled, dose-escalation phase I study.

BACKGROUND: Complementary and alternative medicines are increasingly used for the treatment of asthma in Western countries. A novel three-herb antiasthma herbal medicine intervention (ASHMI; Sino-Lion Pharmaceutical Company; Shan Dong China) was demonstrated to be effective and safe in a murine model of asthma and in a preliminary clinical study in China. OBJECTIVE: The objective of this study was to evaluate the safety and tolerability of ASHMI in adult subjects with allergic asthma. DESIGN: Randomized, double-blind, placebo-controlled, dose escalation, phase I trial aimed at developing a botanical drug under the United States Food and Drug Administration Investigational New Drug title. INTERVENTIONS: Subjects received one of three doses of ASHMI or placebo: 600 mg (2 capsules); 1200 mg (4 capsules); or 1800 mg (6 capsules) twice daily for 1 week. Four (4) ASHMI and 2 placebo subjects were treated at each dose level. Subjects continued to use their conventional asthma medications for the duration of the study. OUTCOME MEASURES: Vital signs, physical examination, laboratory data, and electrocardiogram data were monitored throughout the study to assess occurrence of adverse events (AEs). Immunomodulatory studies were performed to evaluate the effect of ASHMI on cytokine, chemokine, and growth factor levels. RESULTS: Twenty (20) nonsmoking, allergic subjects with asthma were included in the study. Eight (8) subjects (4 ASHMI and 4 placebo) reported mild gastrointestinal symptoms. No grade 3 AEs were observed during the study period. Vital signs, electrocardiogram findings, and laboratory results obtained at pre- and post-treatment visits remained within normal range. No abnormal immunologic alterations were detected. CONCLUSION: In this phase I study, ASHMI appeared to be safe and well tolerated by subjects with asthma. These findings allowed initiation of a larger phase II study to assess the efficacy of ASHMI.