Two-Year Follow-Up of a Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program.

INTRODUCTION: Smoking cessation activities incorporated into lung cancer screening programs have been broadly recommended, but studies to date have not exhibited increased quit rates associated with cessation programs in this setting. We aimed to determine the long-term effectiveness of smoking cessation counseling in smokers presenting for lung cancer screening. METHODS: This was a randomized control trial of an intensive, telephone-based smoking cessation counseling intervention incorporating lung cancer screening results versus usual care (information pamphlet). This analysis reports on the long-term impact (24-mo) of the intervention on abstinence from smoking. RESULTS: A total of 337 active smokers who participated in the screening study were randomized to active smoking cessation counseling (n = 171) or control arm (n = 174) and completed a 24-month assessment. The 30-day smoking abstinence rates at 24 months postrandomization was 18.3% and 21.4% in the control and intervention arms, respectively-a 3.1% difference (95% confidence interval: -5.4 to 11.6, p = 0.48). No statistically significant differences in the 7-day abstinence, the use of pharmacologic cessation aids, nicotine replacement therapies, nor intent to quit in the following 30 days were noted (p > 0.05). The abstinence rates at 24-months were higher overall than at 12-months (19.9% versus 13.3%, p < 0.001), and smoking intensity was lower than at baseline for ongoing smokers. CONCLUSIONS: A telephone-based smoking cessation counseling intervention incorporating lung cancer screening results did not result in increased long-term cessation rates versus written information alone in unselected smokers undergoing lung cancer screening. Overall, quit rates were high and continued to improve throughout participation in the screening program. (ClinicalTrials.govNCT02431962).

A Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program.

INTRODUCTION: Smoking cessation activities incorporated into lung cancer screening programs have been broadly recommended, but studies to date have not shown increased quit rates associated with cessation programs in this setting. We aimed to determine the effectiveness of smoking cessation counseling in smokers presenting for lung cancer screening. METHODS: This study is a randomized control trial of an intensive telephone-based smoking cessation counseling intervention incorporating lung cancer screening results versus usual care (information pamphlet). All active smokers enrolled in the Alberta Lung Cancer Screening Study cohort were randomized on a 1:1 ratio with a primary endpoint of self-reported 30-day abstinence at 12 months. RESULTS: A total of 345 active smokers participating in the screening study were randomized to active smoking cessation counseling (n = 171) or control arm (n = 174). Thirty-day smoking abstinence at 12 months post-randomization was noted in 22 of 174 (12.6%) and 24 of 171 (14.0%) of participants in the control and intervention arms, respectively, a 1.4% difference (95% confidence interval: -5.9 to 8.7, p = 0.7). No statistically significant differences in 7-day or point abstinence were noted, nor were differences at 6 months or 24 months. CONCLUSIONS: A telephone-based smoking cessation counseling intervention incorporating lung cancer screening results did not result in increased 12-month cessation rates versus written information alone in unselected smokers undergoing lung cancer screening. Routine referral of all current smokers to counseling-based cessation programs may not improve long-term cessation in this patient cohort. Future studies should specifically focus on this subgroup of older long-term smokers to determine the optimal method of integrating smoking cessation with lung cancer screening (clinicaltrials.govNCT02431962).

Evaluation of an electronic health record structured discharge summary to provide real time adverse event reporting in thoracic surgery.

BACKGROUND: The reporting of adverse events (AE) remains an important part of quality improvement in thoracic surgery. The best methodology for AE reporting in surgery is unclear. An AE reporting system using an electronic discharge summary with embedded data collection fields, specifying surgical procedure and complications, was developed. The data are automatically transferred daily to a web-based reporting system. METHODS: We determined the accuracy and sustainability of this electronic real time data collection system (ERD) by comparing the completeness of record capture on procedures and complications with coded discharge data (administrative data), and with the standard of chart audit at two intervals. All surgical procedures performed for 2 consecutive months at initiation (Ti) and 1 year later (T1yr) were audited by an objective trained abstractor. A second abstractor audited 10% of the charts. RESULTS: The ERD captured 71/72 (99%) of charts at Ti and 56/65 (86%) at T1yr. Comparing the presence/absence of complications between ERD and chart audit demonstrated at Ti a high sensitivity and specificity, positive predictive value (PPV) of 95.5%, negative predictive value (NPV) of 93.9% with a kappa of 0.872 (95% CI 0.750 to 0.994), and at T1yr a sensitivity, specificity, PPV and NPV of 100% with a kappa of 1.0 (95% CI 1.0). Comparing the presence/absence of complications between administrative data and chart audit at Ti demonstrated a low sensitivity, high specificity and a kappa of 0.471 (95% CI 0.256 to 0.686), and at T1yr a low sensitivity, high specificity of 85% and a kappa of 0.479 (95% CI 0.245 to 0.714). CONCLUSIONS: We found that the ERD can provide accurate real time AE reporting in thoracic surgery, has advantages over previous reporting methodologies and is an alternative system for surgical clinical teams developing AE reporting systems.

Meta-analytic comparison of randomized and nonrandomized studies of breast cancer surgery.

BACKGROUND: Randomized controlled trials (RCTs) are thought to provide the most accurate estimation of "true" treatment effect. The relative quality of effect estimates derived from nonrandomized studies (nRCTs) remains unclear, particularly in surgery, where the obstacles to performing high-quality RCTs are compounded. We performed a meta-analysis of effect estimates of RCTs comparing surgical procedures for breast cancer relative to those of corresponding nRCTs. METHODS: English-language RCTs of breast cancer treatment in human patients published from 2003 to 2008 were identified in MEDLINE, EMBASE and Cochrane databases. We identified nRCTs using the National Library of Medicine's "related articles" function and reference lists. Two reviewers conducted all steps of study selection. We included studies comparing 2 surgical arms for the treatment of breast cancer. Information on treatment efficacy estimates, expressed as relative risk (RR) for outcomes of interest in both the RCTs and nRCTs was extracted. RESULTS: We identified 12 RCTs representing 10 topic/outcome combinations with comparable nRCTs. On visual inspection, 4 of 10 outcomes showed substantial differences in summary RR. The pooled RR estimates for RCTs versus nRCTs differed more than 2-fold in 2 of 10 outcomes and failed to demonstrate consistency of statistical differences in 3 of 10 cases. A statistically significant difference, as assessed by the z score, was not detected for any of the outcomes. CONCLUSION: Randomized controlled trials comparing surgical procedures for breast cancer may demonstrate clinically relevant differences in effect estimates in 20%-40% of cases relative to those generated by nRCTs, depending on which metric is used.

Resolution of chronic diarrhea after resection of a localized pulmonary carcinoid tumor.

Pulmonary carcinoid tumors are rarely associated with symptoms of the carcinoid syndrome, such as flushing and diarrhea. When present, these symptoms virtually always represent extensive hepatic metastases. In this article we describe the presentation, perioperative management, and presumed mechanisms of a patient with a localized pulmonary carcinoid with associated chronic diarrhea that resolved after operation.

REM sleep behaviour disorder treated with melatonin in a patient with Alzheimer's disease.

We report a case of a 68-year-old man with probable Alzheimer's disease who developed rapid eye movement (REM) sleep behaviour disorder. This was confirmed with polysomnography but the patient also had some sleep apnea, which prevented the use of clonazepam for treatment. Melatonin was successfully used as an alternative treatment.

Defining the optimal treatment of locally advanced esophageal cancer: a systematic review and decision analysis.

BACKGROUND: The objective of this study was to combine systematic review and decision analytic techniques to determine the optimal treatment strategy for patients with locally advanced esophageal cancer. METHODS: We performed a systematic review of all randomized trials of patients with locally advanced esophageal cancer that included one of the following strategies compared with surgery alone: chemoradiotherapy followed by surgery, chemotherapy followed by surgery, or surgery with adjuvant chemoradiotherapy. Using the estimates of relative risk for mortality and overall quality of life we constructed a decision model. The outcome of interest was expected quality-adjusted life-years (QALY). RESULTS: The meta-analysis showed for the first year, the relative risk (95% confidence interval) of death for treatments compared with surgery were 0.87 (0.75 to 1.02) for chemoradiotherapy followed by surgery, 0.94 (0.82 to 1.08) for chemotherapy followed by surgery, and 1.33 (0.93 to 1.93) for surgery with adjuvant chemoradiotherapy. The QALYs gained for surgery alone, chemoradiotherapy followed by surgery, chemotherapy followed by surgery, and surgery with adjuvant chemoradiotherapy strategies were 2.07, 2.18, 2.14, and 1.99, respectively. If the reduction in utility for multimodality treatment was increased to 21%, the QALYs gained for surgery alone, chemoradiotherapy followed by surgery, chemotherapy followed by surgery, and surgery with adjuvant chemoradiotherapy were 2.07, 2.03, 1.99, and 1.85, respectively. CONCLUSIONS: Chemoradiotherapy followed by surgery appears to be associated with the best survival and the largest expected gain in QALYs. However, the improvement in quality-adjusted life expectancy is modest at 40 days, and surgery alone becomes the preferred strategy if the reduction in utility associated with multimodality treatment is increased to 21%.

Retrospective analysis of the clinical performance of anterior mediastinotomy.

BACKGROUND: Accurate staging of patients with lung cancer is imperative in generating an appropriate treatment strategy. This study examined the clinical performance of anterior mediastinotomy in staging patients with suspected left upper lobe non-small cell lung cancer. METHODS: This study was designed as a retrospective cohort. All patients with suspected left upper lobe cancer and otherwise normal computed tomography scan results were eligible. Patients with clinically unresectable disease (advanced disease or not fit for surgery) were excluded. After exclusions, 151 patients were stratified into two groups: 117 patients had cervical and anterior mediastinotomy as part of preoperative staging, and 34 had cervical mediastinoscopy only. The primary outcome was rate of preventable thoracotomy defined as thoracotomy during which either metastases to aortopulmonary or paraaortic lymph nodes, or mediastinal invasion was identified. RESULTS: The rate of preventable thoracotomy for the anterior mediastinotomy arm was 4 (3.4%) of 117, compared with 1 (2.9%) of 34 for cervical mediastinoscopy-only arm (p = 0.99). The rate of morbidity in the anterior mediastinotomy arm was 8 (6.8%) of 117, compared with 2 (5.8%) of 34 for the cervical mediastinoscopy-only arm (p = 0.99). Anterior mediastinotomy patients stayed in hospital 1 day longer (p = 0.008). Anterior mediastinotomy was successful at harvesting one or more lymph nodes in 67% of patients. Five patients (4.3%) who underwent anterior mediastinotomy were spared a thoracotomy by identification of metastases to aortopulmonary lymph nodes. CONCLUSIONS: In patients with suspected left upper lobe lung cancer and otherwise normal computed tomography scan results, anterior mediastinotomy does not significantly reduce the rate of preventable thoracotomy.

Levels of evidence and grades of recommendations in general thoracic surgery.

OBJECTIVES: To determine the grades of recommendations and levels of evidence available if the formal practice of evidence-based medicine is applied to general thoracic surgery. METHODS: Three general thoracic surgeons, by consensus, developed a sample of 10 clinically important questions. The first 3 steps of evidence-based medicine (creation of answerable clinical questions, search for best external evidence, and critical appraisal of literature) were performed. Abstracts and appropriate articles were identified through Medline from January 1999 through December 2001. A hierarchical series of search strategies was employed to identify the best level of evidence. The best evidence found was categorized according to the Oxford Centre for Evidence-Based Medicine into 4 grades of recommendations (A-D) and 5 levels of evidence (1-5). RESULTS: The best evidence found for the 10 sample questions was categorized as grade A recommendations in 5 and grade B, also in 5 questions. The levels of evidence found were la in 3 studies, 1b in 5, and 2b in 2. CONCLUSIONS: A formal evidence-based-medicine approach to general thoracic surgery found the grades of recommendation and levels of evidence for a sample of clinically important questions to be high.