Diagnostic Yield and Safety of Pleural Cryobiopsy during Medical Thoracoscopy to Diagnose Pleural Effusion. A Systematic Review and Meta-Analysis.

OBJECTIVE: Current evidence on the diagnostic yield and safety of pleural cryobiopsy (CB) is based on a series of heterogeneous studies with limited cohorts. A pooled analysis of these studies could improve the evidence and contribute to a better understanding of this new technique. METHODOLOGY: We performed a systematic review and meta-analysis of published studies that included data on the yield and diagnostic safety of pleural CB compared with procedures performed using conventional flexible forceps. The heterogeneity of the analysis was evaluated by determining the I2 index, while study quality was measured with the QUADAS-2 tool. RESULTS: Seven studies involving 356 patients were used for the final evaluation. In 55.6%, the etiology of the pleural effusion was malignant, 61.1% of which were lung cancer. The diagnostic yield of pleural CB was 95% (95% CI 92-97) vs. 91% (95% CI 87-94) with conventional flexible forceps (P =  .019). Mild bleeding was reported in 67% of CB procedures (95% CI 62-72) compared with 85% of conventional flexible forceps procedures (95% CI 79-90) (P <  .001). CB specimens were larger, and fewer artifacts were detected. A pooled analysis of the detection of molecular changes could not be performed. Heterogeneity was moderate to high, although the quality of the studies was acceptable. CONCLUSIONS: Pleural CB is a safe technique with a high yield for etiological diagnosis of pleural effusion, and larger specimens with fewer artifacts are obtained. Molecular determinations should be investigated in more depth.

Safety and efficacy of the C-Tb skin test to diagnose Mycobacterium tuberculosis infection, compared with an interferon γ release assay and the tuberculin skin test: a phase 3, double-blind, randomised, controlled trial.

BACKGROUND: Targeted screening and treatment of Mycobacterium tuberculosis infection substantially reduces the risk of developing active tuberculosis. C-Tb (Statens Serum Institute, Copenhagen, Denmark) is a novel specific skin test based on ESAT-6 and CFP10 antigens. We investigated the safety and diagnostic potential of C-Tb compared with established tests in the contact-tracing setting. METHODS: Negative controls, close contacts, occasional contacts, and patients with active pulmonary tuberculosis were enrolled at 13 centres in Spain. We compared C-Tb with the QuantiFERON-TB Gold In-Tube ([QFT] Qiagen, Hilden, Germany) interferon γ release assay (IGRA) and the purified protein derivative (PPD) RT 23 tuberculin skin test ([TST] Statens Serum Institute). All participants older than 5 years were tested with QFT. Some participants in the negative control group received C-Tb without the TST to test for potential interactions between C-Tb and PPD RT 23. The rest were randomly assigned in blocks of ten and tested with both C-Tb and TST, with five in each block receiving injection of C-Tb in the right arm and the TST in the left arm and five vice versa. The primary and safety analyses were done in all participants randomly assigned to a group who received any test. This trial is registered with ClinicalTrials.gov, number NCT01631266, and with EudraCT, number 2011-005617-36. FINDINGS: From July 24, 2012, to Oct 2, 2014, 979 participants were enrolled, of whom 263 were negative controls, 299 were occasional contacts, 316 were close contacts, and 101 were patients with tuberculosis. 970 (99%) participants completed the trial. Induration sizes were similar for C-Tb and TST, but TST positivity was affected by BCG vaccination status. We found a strong positive trend towards C-Tb test positivity with increasing risk of infection, from 3% in negative controls to 16% in occasional contacts, to 43% in close contacts. C-Tb and QFT results were concordant in 785 (94%) of 834 participants aged 5 years and older, and results did not differ significantly between exposure groups. The safety profile of C-Tb was similar to that for the TST. INTERPRETATION: C-Tb delivered IGRA-like results in a field-friendly format. Being unaffected by BCG vaccination status, the C-Tb skin test might provide more accurate treatment guidance in settings where the TST is commonly used. FUNDING: Statens Serum Institut.

Occupational and Biomass Exposure in Chronic Obstructive Pulmonary Disease: Results of a Cross-Sectional Analysis of the On-Sint Study. / Exposición laboral y a biomasa en la enfermedad pulmonar obstructiva crónica: resultados de un análisis transversal del estudio On-Sint.

BACKGROUND: Although tobacco smoke is the main risk factor for chronic obstructive pulmonary disease (COPD), other inhaled toxics have also been associated with the disease. The present study analyzes data from exposure to these substances in a cohort of patients with COPD and assesses their impact on the clinical presentation of the disease. METHODS: This is a cross-sectional analysis of the Clinical presentation, diagnosis and course of chronic obstructive pulmonary disease (On-Sint) study. All patients were smokers or ex-smokers as per protocol. In addition, during the inclusion visit patients were enquired about their occupational and biomass exposure history. The clinical features of patients with and without an added risk factor to tobacco were compared and those significant were entered in a multivariate logistic regression analysis, expressed as odds ratio (OR). RESULTS: The sample size was 1214 patients with COPD, of which 1012 (83.4%) had tobacco as the only risk factor and 202 (16.6%) had additional ones, mainly 174 (14.3%) with occupational gases and 32 (2.6%) with biomass exposure. The geographical distribution of this exposure showed a preference for the northern parts of the country and the East coast. The biomass exposure was rather low. Male gender (OR: 2.180), CAT score (OR: 1.036) and the use of long-term oxygen therapy (OR: 1.642) were associated with having an additional risk factor in the multivariate analysis. CONCLUSIONS: Occupational exposures are more common than biomass in Spain. COPD caused by tobacco plus other inhalants has some differential features and a more impaired quality of life.

Management of malignant pleural effusion by an indwelling pleural catheter: A cost-efficiency analysis.

BACKGROUND: For patients that are expected to survive for longer, the risk of complications combined with the need for more vacuum drainage bottles have become barriers to the placement of indwelling pleural catheter (IPC), since these could increase costs. OBJETIVES: The objective of the current article is to determine the cost and efficiency of treating malignant pleural effusion (MPE) with IPC in Spanish hospitals. METHODS: We compared the cost associated with the use of IPC per outpatient and per inpatient. We analyzed the number of consultations, length of hospital stay, and outcome of the procedure. RESULTS: Fifty-five patients were recruited. Spontaneous pleurodesis was achieved in 34.4% of the cases. Post-catheterization complications were observed in 7.2%. Supplementary procedures were unnecessary and 87.7% of the patients reported improved dyspnea. In 64.9% of the cases, the IPCs were inserted during hospitalization with a median hospitalization time of 4 days (1-7.5). There were differences in the number of visits with more consultations being observed in the outpatient group. There was no difference in the number of vacuum drainage bottles used. The complications supposed a cost increase of €1045.6 per outpatient and €432.54 per inpatient. The overall average cost of treatment per outpatient was €3310.2 and €5450.3 per inpatient. CONCLUSIONS: The treatment with IPC was effective, safe, without need of any more procedures and led to improved dyspnea in more than 85% of the patients. The cost is lower in the outpatient group, although complications represent an increased cost in both groups.

Evaluation of the COPD Assessment Test and GOLD patient types: a cross-sectional analysis.

BACKGROUND: The COPD Assessment Test (CAT) has been recently developed to quantify COPD impact in routine practice. However, no relationship with other measures in the Global Initiative for Obstructive Lung Disease (GOLD) strategy has been evaluated. The present study aimed to evaluate the relationship of the CAT with other GOLD multidimensional axes, patient types, and the number of comorbidities. METHODS: This was a cross-sectional analysis of the Clinical presentation, diagnosis, and course of chronic obstructive pulmonary disease (On-Sint) study. The CAT score was administered to all participants at the inclusion visit. A GOLD 2011 strategy consisting of modified Medical Research Council scale (MRC) scores was devised to study the relationship between the CAT, and GOLD 2011 axes and patient types. The relationship with comorbidities was assessed using the Charlson comorbidity index, grouped as zero, one to two, and three or more. RESULTS: The CAT questionnaire was completed by 1,212 patients with COPD. The CAT maintained a relationship with all the three axes, with a ceiling effect for dyspnea and no distinction between mild and moderate functional impairment. The CAT score increased across GOLD 2011 patient types A-D, with similar scores for types B and C. Within each GOLD 2011 patient type, there was a considerably wide distribution of CAT values. CONCLUSION: Our study indicates a correlation between CAT and the GOLD 2011 classification axes as well as the number of comorbidities. The CAT score can help clinicians, as a complementary tool to evaluate patients with COPD within the different GOLD patient types.