Did psychosocial status, sociodemographics and smoking status affect non-attendance in control participants in the Danish Lung Cancer Screening Trial? A nested observational study.
- 作者列表："Malmqvist J","Siersma V","Thorsen H","Heleno B","Rasmussen JF","Brodersen J
OBJECTIVES:We investigated if psychosocial status, sociodemographics and smoking status affected non-attendance in the control group in the randomised Danish Lung Cancer Screening Trial (DLCST). DESIGN AND SETTING:This study was an observational study nested in the DLCST. Due to large non-attendance in the control group in the second screening round we made an additional effort to collect questionnaire data from non-attenders in this group in the third screening round. We used a condition-specific questionnaire to assess psychosocial status. We analysed the differences in psychosocial status in the third and preceding rounds between non-attenders and attenders in the control group in multivariable linear regression models adjusted for sociodemographics and smoking status reported at baseline. Differences in sociodemographics and smoking status were analysed with χ2 tests (categorical variables) and t-tests (continuous variables). PRIMARY OUTCOME MEASURE:Primary outcome was psychosocial status. PARTICIPANTS:All control persons participating in the third screening round in the DLCST were included. RESULTS:Non-attenders in the third round had significantly worse psychosocial status than attenders in the scales: 'behaviour' 0.77 (99% CI 0.18 to 1.36), 'self-blame' 0.59 (99% CI 0.14 to 1.04), 'focus on airway symptoms' 0.22 (99% CI 0.08 to 0.36), 'stigmatisation' 0.51 (99% CI 0.16 to 0.86), 'introvert' 0.56 (99% CI 0.23 to 0.89) and 'harms of smoking' 0.35 (99% CI 0.11 to 0.59). Moreover, non-attenders had worse scores than attendees in the preceding screening rounds. Non-attenders also reported worse sociodemographics at baseline. CONCLUSIONS:Non-attenders had a significantly worse psychosocial status and worse sociodemographics compared with attenders. The results of our study contribute with evidence of non-response and attrition driven by psychosocial status, which in turn may be influenced by the screening intervention itself. This can be used to adjust cancer screening trial results for bias due to differential non-attendance. TRIAL REGISTRATION NUMBER:Clinicaltrials.gov Protocol Registration System (NCT00496977).
目的: 我们调查了在随机丹麦肺癌筛查试验 (DLCST) 中，心理社会状况、社会人口统计学和吸烟状况是否影响对照组的不出勤。 设计和地点: 本研究是一项嵌套在 DLCST 中的观察性研究。由于对照组在第二轮筛查中有大量未出勤，我们在第三轮筛查中额外努力收集该组未出勤者的问卷数据。我们使用特定条件的问卷来评估社会心理状态。我们在校正了基线时报告的社会人口统计学和吸烟状况的多变量线性回归模型中，分析了对照组中未就诊者和就诊者在第 3 轮和前一轮中的心理社会状态差异。采用 χ 2 检验 (分类变量) 和 t 检验 (连续变量) 分析社会人口统计学和吸烟状况的差异。 主要结局指标: 主要结局为社会心理状态。 参与者: 纳入所有参加 DLCST 第 3 轮筛查的对照组人员。 结果: 第三轮未关注者的社会心理状况显著差于量表中的关注者: “行为” 0.77 (99% CI 0.18 ~ 1.36), '自责' 0.59 (99% CI 0.14 ~ 1.04)，'关注气道症状' 0.22 (99% CI 0.08 ~ 0.36)，'污名化' 0.51 (99% CI 0.16 ~ 0.86)，'内向' 0.56(99% CI 0.23 ~ 0.89) 和 '吸烟的危害' 0.35 (99% CI 0.11 ~ 0.59)。此外，非参试者的得分比前几轮筛选中的参试者差。未就诊者在基线时也报告了更差的社会人口统计学。 结论: 与关注者相比，未关注者的心理社会状况显著较差，社会人口统计学较差。我们的研究结果提供了心理社会状态驱动的无反应和损耗的证据，而心理社会状态又可能受到筛查干预本身的影响。这可用于调整癌症筛查试验结果，以确定因不同不出勤而产生的偏倚。 试用注册号: Clinicaltrials.gov 协议注册系统 (NCT00496977)。
METHODS:BACKGROUND:The objectives of this study are to assess the chest drainage volumes of patients undergoing anatomic resection of non-small cell lung carcinoma and to determine the safety and effectiveness of administering enoxaparin for thromboprophylaxis. METHODS:A total of 77 patients were included in the study. A study was conducted on the first group of 42 patients in which enoxaparin prophylaxis (enoxaparin, 40 mg) was subcutaneously injected once a day for a period of three days after the patients underwent anatomic pulmonary resection between March 2016 and March 2018. An enoxaparin-free group was identified and included 35 patients who received no enoxaparin prophylaxis after undergoing anatomic pulmonary resection between February 2013 and February 2016. We compared the changes in hemoglobin (Hb) levels, postoperative 3-day drainage volume, transfusion volume, pulmonary complications and length of stay between the two groups. RESULTS:No differences in postoperative Hb levels, chest drainage volume, transfusion volume, postoperative complications, and length of stay were observed between the two groups. Deep-vein thrombosis was noted in a patient in the enoxaparin-free group. No major bleeding was noted in either group. CONCLUSION:We found that for patients undergoing anatomic resection of primary lung cancer, the blood transfusion and chest drainage volumes did not differ, regardless of whether the patients were given enoxaparin. To the best of our knowledge, the impact of low-molecular-weight heparin on chest tube drainage volume for patients undergoing anatomic resection of non-small cell lung carcinoma has not been investigated before.
METHODS::The aim of the present study was to compare the safety and efficacy of cryoablation (CA) and microwave ablation (MWA) as treatments for non-small cell lung cancer (NSCLC). Patients with stage IIIB or IV NSCLC treated with CA (n=45) or MWA (n=56) were enrolled in the present study. The primary endpoint was progression-free survival (PFS); the secondary endpoints included overall survival (OS) time and adverse events (AEs). The median PFS times between the two groups were not significantly different (P=0.36): CA, 10 months [95% confidence interval (CI), 7.5-12.4] vs. MWA, 11 months (95% CI, 9.5-12.4). The OS times between the two groups were also not significantly different (P=0.07): CA, 27.5 months (95% CI, 22.8-31.2 months) vs. MWA, 18 months (95% CI, 12.5-23.5). For larger tumors (>3 cm), patients treated with MWA had significantly longer median PFS (P=0.04; MWA, 10.5 months vs. CA, 7.0 months) and OS times (P=0.04; MWA, 24.5 months vs. CA, 14.5 months) compared patients treated with CA. However, for smaller tumors (≤3 cm), median PFS (P=0.79; MWA, 11.0 months vs. CA, 13.0 months) and OS times (P=0.39; MWA, 30.0 months vs. CA, 26.5 months) between the two groups did not differ significantly. The incidence rates of AEs were similar in the two groups (P>0.05). The number of applicators, tumor size and length of the lung traversed by applicators were associated with a higher risk of pneumothorax and intra-pulmonary hemorrhage in the two groups. Treatment with CA resulted in significantly less intraprocedural pain compared with treatment with MWA (P=0.001). Overall, the present study demonstrated that CA and MWA were comparably safe and effective procedures for the treatment of small tumors. However, treatment with MWA was superior compared with CA for the treatment of large tumors.
METHODS:BACKGROUND:BRAF mutations occurring in 1%-5% of patients with non-small-cell lung cancer (NSCLC) are therapeutic targets for these cancers but the impact of the exact mutation on clinical activity is unclear. The French National Cancer Institute (INCA) launched the AcSé vemurafenib trial to assess the efficacy and safety of vemurafenib in cancers with various BRAF mutations. We herein report the results of the NSCLC cohort. PATIENTS AND METHODS:Tumour samples were screened for BRAF mutations in INCA-certified molecular genetic centres. Patients with BRAF-mutated tumours progressing after ≥1 line of treatment were proposed vemurafenib 960 mg twice daily. Between October 2014 and July 2018, 118 patients were enrolled in the NSCLC cohort. The primary outcome was the objective response rate (ORR) assessed every 8 weeks (RECIST v1.1). A sequential Bayesian approach was planned with an inefficacy bound of 10% for ORR. If no early stopping occurred, the treatment was of interest if the estimated ORR was ≥30% with a 90% probability. Secondary outcomes were tolerance, response duration, progression-free survival (PFS), and overall survival (OS). RESULTS:Of the 118 patients enrolled, 101 presented with a BRAFV600 mutation and 17 with BRAFnonV600 mutations; the median follow-up was 23.9 months. In the BRAFnonV600 cohort, no objective response was observed and this cohort was stopped. In the BRAFV600 cohort, 43/96 patients had objective responses. The mean Bayesian estimated success rate was 44.9% [95% confidence intervals (CI) 35.2%-54.8%]. The ORR had a 99.9% probability of being ≥30%. Median response duration was 6.4 months, median PFS was 5.2 months (95% CI 3.8-6.8), and OS was 10 months (95% CI 6.8-15.7). The vemurafenib safety profile was consistent with previous publications. CONCLUSION:Routine biomarker screening of NSCLC should include BRAFV600 mutations. Vemurafenib monotherapy is effective for treating patients with BRAFV600-mutated NSCLC but not those with BRAFnonV600 mutations. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02304809.