Difficulties on the access to innovative targeted therapies for lung cancer in Spain

Purpose Spanish Lung Cancer Group (SLCG) conducted a review to analyze the barriers to access to innovative targeted therapies for non-small cell lung cancer (NSCLC) in clinical practice in Spain. Methods Review all relevant content published on websites of European Commission, European Medicines Agency, and Spanish Agency of Medicines and Medical Products regarding the authorization and access to oncology treatments. Results More than 20 targeted therapies are available to treat different molecular alterations in patients with NSCLC. European Commission has approved treatments for genomic alterations involving the following genes: ALK, RET, ROS1, EGFR, BRAF, NTRK, KRAS, MET. However, the availability of these therapies in Spain is not complete, as innovative treatments are not reimbursed or funded late, with only five of these alterations currently covered by National Health System. Conclusion SLCG considers imperative to improve the access in Spain to innovative treatments for NSCLC to reduce inequity across European countries (AU)

Difficulties on the access to innovative targeted therapies for lung cancer in Spain.

PURPOSE: Spanish Lung Cancer Group (SLCG) conducted a review to analyze the barriers to access to innovative targeted therapies for non-small cell lung cancer (NSCLC) in clinical practice in Spain. METHODS: Review all relevant content published on websites of European Commission, European Medicines Agency, and Spanish Agency of Medicines and Medical Products regarding the authorization and access to oncology treatments. RESULTS: More than 20 targeted therapies are available to treat different molecular alterations in patients with NSCLC. European Commission has approved treatments for genomic alterations involving the following genes: ALK, RET, ROS1, EGFR, BRAF, NTRK, KRAS, MET. However, the availability of these therapies in Spain is not complete, as innovative treatments are not reimbursed or funded late, with only five of these alterations currently covered by National Health System. CONCLUSION: SLCG considers imperative to improve the access in Spain to innovative treatments for NSCLC to reduce inequity across European countries.

The Use of Fissios App© as a Complement to a Face-to-Face Respiratory Physiotherapy Program versus an Attendance-Only Face-to-Face Physiotherapy Program in Patients Scheduled for Thoracic Surgical Procedures Reduces the Risk of Developing Postoperative Pulmonary Complications-A Quasi-Experimental Study.

Postoperative pulmonary complications (PPCs) increase the hospital length of stay (LOS) and the cost of healthcare associated with surgical procedures. Strategies to reduce PPCs begin before surgery and continue in the postoperative period. Fissios App© is a smartphone application that contains perioperative medical advice and a structured respiratory physiotherapy program. The objective was to implement the use of this app in a group of patients scheduled for a thoracic surgical procedure and determine its efficacy in reducing PPCs. This was a quasi-experimental study in which all patients attended a face-to-face respiratory physiotherapy program, and the intervention group used Fissios App© as a complement. We prospectively recorded the postoperative evolution of both groups, analyzed the categorical differences and quantitative variables, and created a binary logistic regression model. We recruited 393 patients (131 intervention and 262 control). The intervention group had a lower incidence of PPCs (12.2% versus 24% in the control group, p = 0.006), a shorter LOS (a median of 3 days (IQR = 2-5) versus 4 days (IQR = 3-6, p = 0.001) in the control group), and a reduction in the risk of developing PPCs by 63.5% (OR: 0.365, 95% CI: 0.17-0.78). The use of Fissios App© improved the clinical outcomes after surgery and reduced the probability of developing PPCs.

Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer.

BACKGROUND: Approximately 20% of patients with non-small-cell lung cancer (NSCLC) receive a diagnosis of stage III disease. There is no current consensus regarding the most appropriate treatment for these patients. METHODS: In this open-label, phase 2 trial, we randomly assigned patients with resectable stage IIIA or IIIB NSCLC to receive neoadjuvant nivolumab plus platinum-based chemotherapy (experimental group) or chemotherapy alone (control group), followed by surgery. Patients in the experimental group who had R0 resections received adjuvant treatment with nivolumab for 6 months. The primary end point was a pathological complete response (0% viable tumor in resected lung and lymph nodes). Secondary end points included progression-free survival and overall survival at 24 months and safety. RESULTS: A total of 86 patients underwent randomization; 57 were assigned to the experimental group and 29 were assigned to the control group. A pathological complete response occurred in 37% of the patients in the experimental group and in 7% in the control group (relative risk, 5.34; 95% confidence interval [CI], 1.34 to 21.23; P = 0.02). Surgery was performed in 93% of the patients in the experimental group and in 69% in the control group (relative risk, 1.35; 95% CI, 1.05 to 1.74). Kaplan-Meier estimates of progression-free survival at 24 months were 67.2% in the experimental group and 40.9% in the control group (hazard ratio for disease progression, disease recurrence, or death, 0.47; 95% CI, 0.25 to 0.88). Kaplan-Meier estimates of overall survival at 24 months were 85.0% in the experimental group and 63.6% in the control group (hazard ratio for death, 0.43; 95% CI, 0.19 to 0.98). Grade 3 or 4 adverse events occurred in 11 patients in the experimental group (19%; some patients had events of both grades) and 3 patients in the control group (10%). CONCLUSIONS: In patients with resectable stage IIIA or IIIB NSCLC, perioperative treatment with nivolumab plus chemotherapy resulted in a higher percentage of patients with a pathological complete response and longer survival than chemotherapy alone. (Funded by Bristol Myers Squibb and others; NADIM II ClinicalTrials.gov number, NCT03838159; EudraCT number, 2018-004515-45.).

Implementación de una app de cuidados perioperatorios en cirugía torácica electiva / Implementation of a perioperative care App in elective thoracic surgery

Introducción: La inconsistencia en el diseño e implementación de los programas de cuidados perioperatorios limita su universalización, y es aquí donde las tecnologías en salud pueden estandarizar estos procesos. El objetivo del estudio es crear una app para smartphone con un programa de cuidados perioperatorios, implementarla en un grupo de pacientes programados para un procedimiento quirúrgico torácico y evaluar su utilización. Métodos: Estudio prospectivo y descriptivo. Se creó una app (Fissios App) que contiene 40 recomendaciones perioperatorias y un programa de 10 ejercicios de fisioterapia respiratoria. A los pacientes se les recomendó utilizarla antes y después de la cirugía; para medir su utilización se creó y se aplicó un cuestionario. Se realizó un análisis descriptivo de las variables de los pacientes, las respuestas del cuestionario y se evaluó su asociación. Resultados: Se incluyeron 131 pacientes, el 60,3% eran varones con una mediana de edad de 62 años (51-71), y el 26,72% habían completado estudios secundarios. El 89,3% resaltaron la facilidad para descargar y configurar la app. Más del 90% de los pacientes valoraron positivamente la claridad para explicar los ejercicios respiratorios y las recomendaciones perioperatorias. Ciento cuatro (79,4%) pacientes destacaron la contribución del uso de la app para afrontar el postoperatorio. Conclusiones: Se creó una app (Fissios App) con un programa de cuidados perioperatorios y se implementó satisfactoriamente sin importar la edad ni el nivel educativo de los pacientes. La herramienta explica claramente la información contenida, y su uso antes de la cirugía les ayudó a afrontar el postoperatorio, con un nivel adecuado de exigencia física y de tiempo de uso. (AU)

Introduction: The design and implementation inconsistency of perioperative care programs limits their universalization, and it is where e-Health can standardize these processes. The objective of the study is to create a Smartphone app with a perioperative care program, implement it in a group of patients scheduled for a thoracic surgical procedure, and evaluates its use. Methods: A prospective and descriptive study. We created a Smartphone app (Fissios App) which contains 40 perioperative recommendations and 10 chest physical exercises. Patients were recommended to use it before and after surgery; to measure its use, we created and applied a questionnaire. A descriptive analysis of patient variables and questionnaire responses was performed and their association evaluated. Results: One hundred fourpatients were included, the 60.3% were men with a median age of 62 years (51-71), and 26.72% had completed high school. The 89.3% of patients highlighted the ease of downloading and setting up the app. More than 90% of patients positively assessed clarity in explaining chest physical exercises and perioperative recommendations. One hundred four (79.4%) patients highlighted the contribution of the use of the app during the preoperative period to face the postoperative period. Conclusions: We created a Smartphone app (Fissios App) with a perioperative care program and it was successfully implemented regardless of the age or educational level of patients. The tool clearly explains the information contained and the patients reported that its use before surgery helped them to face the postoperative period, with an appropriate level of physical demand and time of use. (AU)

Implementation of a perioperative care App in elective thoracic surgery.

INTRODUCTION: The design and implementation inconsistency of perioperative care programs limits their universalization, and it is where e-Health can standardize these processes. The objective of the study is to create a Smartphone App with a perioperative care program, implement it in a group of patients scheduled for a thoracic surgical procedure, and evaluates its use. METHODS: A prospective and descriptive study. We created a Smartphone app (Fissios App) which contains 40 perioperative recommendations and 10 chest physical exercises. Patients were recommended to use it before and after surgery; to measure its use, we created and applied a questionnaire. A descriptive analysis of patient variables and questionnaire responses was performed and their association evaluated. RESULTS: One hundred four patients were included, 60.3% were men with a median age of 62 years (51-71), and 26.72% had completed high school. The 89.3% of patients highlighted the ease of downloading and setting up the app. More than 90% of patients positively assessed clarity in explaining chest physical exercises and perioperative recommendations. One hundred four (79.4%) patients highlighted the contribution of the use of the app during the preoperative period to face the postoperative period. CONCLUSIONS: We created a Smartphone app (Fissios App) with a perioperative care program and it was successfully implemented regardless of the age or educational level of patients. The tool clearly explains the information contained and the patients reported that its use before surgery helped them to face the postoperative period, with an appropriate level of physical demand and time of use.

Preoperative detection and evaluation of the need for psychological intervention in cancer and non-cancer patients referred to thoracic surgery.

OBJECTIVES: (a) to evaluate and compare the psychological treatment needs of patients with cancer and non-cancer, who are going to undergo scheduled thoracic surgery, and (b) evaluate and compare the diagnostic accuracy of the screening tests of psychological treatment needs for cancer and non-cancer patients. METHOD: The need for psychological treatment was evaluated in a total of 169 patients prior to thoracic surgery, through a clinical interview. The screening tests used were: the physician's judgment (yes/no), the Hospital Anxiety and Depression Scale (HADS) and, the single-item interview to assess depression "Do you feel depressed?" (DEPQ). RESULTS: The number of patients who needed psychological treatment in the total sample was 47 (27.81%), in non-cancer-patients: 22 (30.99%) and in cancer patients: 25 (25.51%). The participants with treatment needs were more often young women with primary education levels, with more fears and concerns regarding their disease. With respect to the screening tests, the HADS-T (cut-off point ≥13) obtained a sensitivity (SE) of 0.75 and Specificity (SP) of 0.81 in the total sample. In patients with cancer, the HADS total score (cut-off point ≥10) obtained an SE=0.84 and SP=0.80, and, in non-cancer patients, the HADS total score (cut-off point ≥13) showed an SE=0.59 and SP=0.84. The DEPQ and the physician's judgment did not achieve adequate levels of precision. CONCLUSIONS: A high percentage of patients have psychological treatment needs before performing thoracic surgery, which are similar for cancer and non-cancer patients. Preoperative detection of patients who need psychological intervention is feasible with a simple screening test: HADS, which achieves greater precision in cancer patients.

Thoracic surgery in Spain.

In this manuscript, we briefly report on the Spanish health care system and the current situation of Thoracic Surgery in the country. Our surgical speciality is approached in terms of national spread of thoracic units, education, technological development, and other relevant aspects. Thoracic Surgery national workforce is also reviewed and compared to sister specialities. Prospects and authors' recommendations for development are included. Total cost of public health care expenditure in Spain represents 9% of the gross domestic product (GDP) and the National Health System is included in the top ten more efficient systems in the World. Thoracic Surgery in Spain is an independent medical speciality. The access to training in accredited hospitals is uniformly regulated all around the country and represents the official and only route to certified medical specialization. 0.5 certified specialists in Thoracic Surgery per 100,000 habitants are working in the country, half of them being female in the age subset of 30-39. Currently, more than half of all anatomical resection in the country are performed via VATS. Seven centres are currently accredited by the Ministry of Health for lung transplantation, and the current rate of lung transplants is 7.1 per million of population. To note is the success of the non-heart-beating donors program developed in recent years. Three national professional and scientific societies are gathering most Spanish thoracic surgeons and promoting cooperative multidisciplinary studies on lung cancer and surgical techniques such are video-assisted and robotic lung resection. Implementing a national database of thoracic surgical procedures would be advisable to promote continuous clinical quality improvements.

Impact of neoadjuvant therapy on postoperative complications in non-small-cell lung cancer patients subjected to anatomic lung resection.

OBJECTIVE: To study the impact of neoadjuvant therapies on postoperative complications and mortality among non-small-cell lung cancer (NSCLC) patients subjected to anatomic lung resection and included in the Spanish cohort of the video-assisted thoracic surgery (GE-VATS) multicenter database. METHODS: The study included a total of 3085 patients from 33 centers between December 2016 and March 2018. We performed a comparative analysis of the complications and mortality in patients who received neoadjuvant therapies (n = 263) versus those who did not (n = 2822). A propensity score-matched analysis was used to adjust for potential confounders. Association between exposure in two groups and outcomes were estimated by logistic regression weighted by inverse of probability of receiving the treatment that actually received. RESULTS: In the unadjusted analysis, the chemotherapy (CT) and chemoradiotherapy (CRT) group presented a higher frequency of ICU readmissions, reinterventions, empyema, cardiovascular complications, a greater frequency of atrial fibrillation, and an increased need for blood product transfusions. In the adjusted group, CT and CRT patients had a higher rate of cardiovascular complications (CT p = 0.002; OR 2.29; 95% CI 1.34-3.94 and CRT p = 0.001; OR 2.90; 95% CI 1.52-5-52), arrhythmias (CT p = 0.013; OR 2.23; 95% CI 1.18-4.20 and CRT p = 0.046; OR 2.22; 95% CI 1.01-4.90) and transfussions (CT p = 0.042; OR 2.95; 95% CI 1.04-8.35 and CRT p < 0.001; OR 7.74; 95% CI 3.01-19-92). CONCLUSIONS: Based on our series, neoadjuvant CT and CRT were associated with a higher rate of cardiovascular complications, arrhythmias and transfussions in patients with NSCLC subjected to anatomic lung resection.

Targeted therapy moves to earlier stages of non-small-cell lung cancer: emerging evidence, controversies and future challenges.

Lung cancer continues to be the leading cause of cancer mortality and a serious health problem despite the numerous advances made in the last decade and the rapid advance of research in this field. In recent years, there has been a decrease in mortality from lung cancer coinciding with the approval times of targeted therapy. To date, targeted therapy has been used in the context of advanced disease in clinical practice, with great benefits in survival and quality of life. The next step will be to incorporate targeted therapy into the treatment of earlier stages of non-small-cell lung cancer, and there is already a randomized trial showing a disease-free survival benefit. However, there are many questions that need to be resolved first. In the present review, the authors discuss the findings of published reports and ongoing clinical trials assessing the role of targeted therapies in nonmetastatic disease.

Lay abstract Despite major therapeutic advances over the last decade, lung cancer continues to present the highest mortality rate of all cancers. Precision and personalized therapy directed at specific alterations in the genetic material of the tumor as well as immunotherapy has significantly improved survival in metastatic non-small-cell lung cancer. The next step will be to incorporate precision medicine into the treatment of earlier stages of non-small-cell lung cancer. The recent publication of the results of the ADAURA phase III trial showing a significant improvement in disease-free survival in patients with resected EGFR-mutated non-small-cell lung cancer who received an adjuvant EGFR-directed tyrosine kinase inhibitor called osimertinib has opened the doors to the incorporation of this novel agent into routine clinical practice. However, there are many questions that need to be resolved first. In the present review, the authors discuss the findings of published reports and ongoing clinical trials assessing the role of precision medicine in nonmetastatic disease.

Effect of COVID-19 on Thoracic Oncology Surgery in Spain: A Spanish Thoracic Surgery Society (SECT) Survey.

After the first wave of COVID-19, the Spanish Society of Thoracic Surgeons (SECT) surveyed its members to assess the impact of the pandemic on thoracic oncology surgery in Spain. In May 2020, all SECT members were invited to complete an online, 40-item, multiple choice questionnaire. The questionnaire was developed by the SECT Scientific Committee and sent via email. The overall response rate was 19.2%. The respondents answered at least 91.5% of the items, with only one exception (a question about residents). Most respondents (89.3%) worked in public hospitals. The reported impact of the pandemic on routine clinical activity was considered extreme or severe by 75.5% of respondents (25.5% and 50%, respectively). Multidisciplinary tumour boards were held either with fewer members attending or through electronic platforms (44.6% and 35.9%, respectively). Surgical activity decreased by 95.7%, with 41.5% of centers performing surgery only on oncological patients and 11.7% only in emergencies. Nearly 60% of respondents reported modifying standard protocols for early-stage cancer and in the preoperative workup. Most centers (≈80%) reported using full personal protective equipment when operating on COVID-19 positive patients. The COVID-19 pandemic severely affected thoracic oncology surgery in Spain. The lack of common protocols led to a variable care delivery to lung cancer patients.

Spanish Lung Cancer Group SCAT trial: surgical audit to lymph node assessment based on IASLC recommendations.

BACKGROUND: The Spanish Customized Adjuvant Therapy (SCAT) trial assessed the role of individualized adjuvant therapy in clinical N0 incidental pN1 and/or N2 non-small cell lung cancer (NSCLC) completely resected. We assessed surgical topics with an in-depth analysis of quality of lymphadenectomy based on International Association for the Study of Lung Cancer (IASLC) recommendations. METHODS: Patients with information about lymphadenectomy available were included (N=451). Prospectively collected data about tumor, type of resection, and postoperative morbidity and quality of lymph node dissection (LND) were retrospectively evaluated. Role of lymph node assessment on survival was analyzed using Kaplan-Meier curves, using regression models to identify prognostic factors. RESULTS: In 33.7%, 17.7% and 49.9% of cases, regions 7, 10 and 11 respectively were not assessed. In 21.1% of patients, less than three lymph node regions were biopsied, while in 19.6% of patients less than six lymph nodes were assessed. In 53,4% of patients only one N1 region was evaluated. From patients with positive N2, 8.9% had no N1 regions biopsied. Twenty-nine percent of patients with at least one N2 lymph node resected shown the highest region involved. Thirty-day postoperative mortality was unknown. Five-year overall survival (OS) was 61.7% (95% CI: 55.4-67.4%), 51.5% (95% CI: 39.2-62.4%) and 42.3% (95% CI: 32.1-52.2%) for patients with N1, N2 and N1+N2 disease, respectively (P<0.01). Both number of lymph nodes resected and number of lymph nodes involved by tumor were significantly related to prognosis. CONCLUSIONS: IASLC recommendations for surgical resections were not followed in a high proportion of surgical procedures. Hilar and mediastinal lymph node assessment and involvement showed to impact prognosis. Surgical issues such as postoperative mortality could not be evaluated owing to trial design.

Preoperative detection and evaluation of the need for psychological intervention in cancer and non-cancer patients referred to thoracic surgery.

OBJECTIVES: (a) to evaluate and compare the psychological treatment needs of patients with cancer and non-cancer, who are going to undergo scheduled thoracic surgery, and (b) evaluate and compare the diagnostic accuracy of the screening tests of psychological treatment needs for cancer and non-cancer patients. METHOD: The need for psychological treatment was evaluated in a total of 169 patients prior to thoracic surgery, through a clinical interview. The screening tests used were: the physician's judgment (yes/no), the Hospital Anxiety and Depression Scale (HADS) and, the single-item interview to assess depression "Do you feel depressed?" (DEPQ). RESULTS: The number of patients who needed psychological treatment in the total sample was 47 (27.81%), in non-cancer-patients: 22 (30.99%) and in cancer patients: 25 (25.51%). The participants with treatment needs were more often young women with primary education levels, with more fears and concerns regarding their disease. With respect to the screening tests, the HADS-T (cut-off point ≥13) obtained a sensitivity (SE) of 0.75 and Specificity (SP) of 0.81 in the total sample. In patients with cancer, the HADS total score (cut-off point ≥10) obtained an SE=0.84 and SP=0.80, and, in non-cancer patients, the HADS total score (cut-off point ≥13) showed an SE=0.59 and SP=0.84. The DEPQ and the physician's judgment did not achieve adequate levels of precision. CONCLUSIONS: A high percentage of patients have psychological treatment needs before performing thoracic surgery, which are similar for cancer and non-cancer patients. Preoperative detection of patients who need psychological intervention is feasible with a simple screening test: HADS, which achieves greater precision in cancer patients.

Immunotherapy Moves to the Early-Stage Setting in Non-Small Cell Lung Cancer: Emerging Evidence and the Role of Biomarkers.

Despite numerous advances in targeted therapy and immunotherapy in the last decade, lung cancer continues to present the highest mortality rate of all cancers. Targeted therapy based on specific genomic alterations, together with PD-1 and CTLA-4 axis blocking-based immunotherapy, have significantly improved survival in advanced non-small cell lung cancer (NSCLC) and both therapies are now well-established in this clinical setting. However, it is time for immunotherapy to be applied in patients with early-stage disease, which would be an important qualitative leap in the treatment of lung cancer patients with curative intent. Preliminary data from a multitude of studies are highly promising, but therapeutic decision-making should be guided by an understanding of the molecular features of the tumour and host. In the present review, we discuss the most recently published studies and ongoing clinical trials, controversies, future challenges and the role of biomarkers in the selection of best therapeutic options.

Spanish Video-Assisted Thoracic Surgery Group: Method, Auditing, and Initial Results From a National Prospective Cohort of Patients Receiving Anatomical Lung Resections / Grupo Español de Cirugía Torácica Videoasistida: Método, Auditoría y Resultados Iniciales de una Cohorte Nacional Prospectiva de Pacientes Tratados con Resección Pulmonar Anatómica

INTRODUCTION: Our study sought to know the current implementation of video-assisted thoracoscopic surgery (VATS) for anatomical lung resections in Spain. We present our initial results and describe the auditing systems developed by the Spanish VATS Group (GEVATS). METHODS: We conducted a prospective multicentre cohort study that included patients receiving anatomical lung resections between 12/20/2016 and 03/20/2018. The main quality controls consisted of determining the recruitment rate of each centre and the accuracy of the perioperative data collected based on six key variables. The implications of a low recruitment rate were analysed for "90-day mortality" and "Grade IIIb-V complications". RESULTS: The series was composed of 3533 cases (1917 VATS; 54.3%) across 33 departments. The centres' median recruitment rate was 99% (25-75th:76-100%), with an overall recruitment rate of 83% and a data accuracy of 98%. We were unable to demonstrate a significant association between the recruitment rate and the risk of morbidity/mortality, but a trend was found in the unadjusted analysis for those centres with recruitment rates lower than 80% (centres with 95-100% rates as reference): grade IIIb-V OR = 0.61 (p = 0.081), 90-day mortality OR = 0.46 (p = 0.051). CONCLUSIONS: More than half of the anatomical lung resections in Spain are performed via VATS. According to our results, the centre's recruitment rate and its potential implications due to selection bias, should deserve further attention by the main voluntary multicentre studies of our speciality. The high representativeness as well as the reliability of the GEVATS data constitute a fundamental point of departure for this nationwide cohort

INTRODUCCIÓN: Nuestro estudio buscó conocer el grado de implementación actual de la cirugía toracoscópica asistida por video (VATS, por sus siglas en inglés) para las resecciones pulmonares anatómicas en España. Presentamos nuestros resultados iniciales y describimos los sistemas de auditoría desarrollados por el grupo español de VATS (GEVATS). MÉTODOS: Realizamos un estudio de cohortes prospectivo multicéntrico que incluyó pacientes que fueron tratados con resecciones pulmonares anatómicas entre el 20/12/2016 y el 20/03/2018. Los controles de calidad principales consistieron en determinar la tasa de reclutamiento de cada centro y la precisión de los datos perioperatorios recolectados en base a seis variables clave. Se analizaron las implicaciones de una baja tasa de reclutamiento para "mortalidad a los 90 días" y "complicaciones de grado IIIb-V". RESULTADOS: La serie estaba compuesta por 3533 casos (1917 VATS; 54,3%) en 33 servicios. La mediana de la tasa de reclutamiento de los centros fue del 99% (p25-p75: 76-100%), con una tasa de reclutamiento global del 83% y una precisión de los datos del 98%. No pudimos demostrar una asociación significativa entre la tasa de reclutamiento y el riesgo de morbi-mortalidad, pero se encontró una tendencia en el análisis no ajustado para aquellos centros con tasas de reclutamiento inferiores al 80% (usando los centros con tasas de 95-100% como referencia): OR = 0,61 para el grado IIIb-V (p = 0,081), OR = 0,46 para la mortalidad a los 90 días (p = 0,051). CONCLUSIONES: Más de la mitad de las resecciones pulmonares anatómicas en España se realizan a través de VATS. Según nuestros resultados, la tasa de reclutamiento del centro y sus posibles implicaciones debido al sesgo de selección, deberían recibir más atención por parte de los principales estudios multicéntricos voluntarios de nuestra especialidad. La alta representatividad y la confiabilidad de los datos de GEVATS constituyen un punto de partida fundamental para esta cohorte nacional

When the Need is Greater Than Feasible / Cuando la necesidad es mayor de lo factible

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Spanish Video-Assisted Thoracic Surgery Group: Method, Auditing, and Initial Results From a National Prospective Cohort of Patients Receiving Anatomical Lung Resections.

INTRODUCTION: Our study sought to know the current implementation of video-assisted thoracoscopic surgery (VATS) for anatomical lung resections in Spain. We present our initial results and describe the auditing systems developed by the Spanish VATS Group (GEVATS). METHODS: We conducted a prospective multicentre cohort study that included patients receiving anatomical lung resections between 12/20/2016 and 03/20/2018. The main quality controls consisted of determining the recruitment rate of each centre and the accuracy of the perioperative data collected based on six key variables. The implications of a low recruitment rate were analysed for "90-day mortality" and "Grade IIIb-V complications". RESULTS: The series was composed of 3533 cases (1917 VATS; 54.3%) across 33 departments. The centres' median recruitment rate was 99% (25-75th:76-100%), with an overall recruitment rate of 83% and a data accuracy of 98%. We were unable to demonstrate a significant association between the recruitment rate and the risk of morbidity/mortality, but a trend was found in the unadjusted analysis for those centres with recruitment rates lower than 80% (centres with 95-100% rates as reference): grade IIIb-V OR=0.61 (p=0.081), 90-day mortality OR=0.46 (p=0.051). CONCLUSIONS: More than half of the anatomical lung resections in Spain are performed via VATS. According to our results, the centre's recruitment rate and its potential implications due to selection bias, should deserve further attention by the main voluntary multicentre studies of our speciality. The high representativeness as well as the reliability of the GEVATS data constitute a fundamental point of departure for this nationwide cohort.

Implementación de un programa de cribado del malestar emocional en un servicio de cirugía torácica / Implementing a distress screening program in a thoracic surgery service

Introducción: El objetivo del presente estudio es examinar la precisión diagnóstica de los test de cribado utilizados para detectar la necesidad de atención psicológica en pacientes remitidos para cirugía torácica. Métodos: Se evaluó la presencia de malestar emocional en un total de 105 pacientes remitidos para cirugía torácica por medio de la entrevista clínica psicológica (variable criterio). Los métodos de cribado utilizados fueron: el juicio del médico (sí/no), la Escala Hospitalaria de Ansiedad y Depresión (HADS), la pregunta única para evaluar depresión "¿se siente usted deprimido?" (ADEP) (1-5) y la pregunta única para medir ansiedad "¿se siente ansioso?" (AANA) (1-5). Resultados: De acuerdo con la entrevista entrevista clínica psicológica, el 34% de los pacientes fueron casos clínicos que requerían intervención psicológica. La puntuación total de la escala HADS (punto de corte 10) mostró una sensibilidad del 0,89, especificidad del 0,75 y un ABC de 0,883; la ADEP (punto de corte 1) mostró una sensibilidad del 0,79, especificidad del 0,74 y ABC del 0,795; la AANS (>1) obtuvo una sensibilidad del 0,78, especificidad del 0,41 y ABC de 0,69 y el juicio del médico mostró una sensibilidad del 0,47 y especificidad del 0,86. Conclusiones: Un alto porcentaje de pacientes remitidos para cirugía torácica requirieron intervención psicológica. El mejor instrumento para identificar a aquellos pacientes con necesidades psicológicas, tomando la entrevista psicológica como variable criterio, fue la puntuación total del HADS. Este instrumento es simple y breve, bien aceptado por los pacientes, de fácil aplicación en un servicio de cirugía torácica y tiene buena capacidad diagnóstica

Introduction: The aim of the present study was to examine the diagnostic accuracy of screening tests in detecting cases requiring psychological intervention among patients referred for thoracic surgery. Methods: Emotional distress was evaluated in 105 patients referred for thoracic surgery by means of a diagnostic psychological interview (criterion variable). The screening ability of the following methods was analyzed: the physician's opinion (Yes/No), Hospital Anxiety and Depression Scale (HADS), single-item interview: «Are you depressed?» (Depression Question, ADEP) (1-5) and the single-item interview: «Are you anxious?» (Anxiety Question, ANXQ) (1-5). Results: According to the clinical interview, 34% of the patients were clinical cases requiring psychological intervention. The total HADS (cut-off point of 10) showed a sensitivity = 0.89, specificity = 0.75 and AUC = 0.883; the ADEP scale (>1) showed a sensitivity = 0.79, specificity = 0.74 and AUC = 0.795; the ANXQ scale (>1) showed a sensitivity = 0.78, specificity = 0.41 and AUC = 0.690; and the physician's opinion showed a sensitivity = 0.47 and specificity = 0.86. Conclusions: A high percentage of patients referred for thoracic surgery required psychological intervention. The best instrument to identify those patients requiring psychological care, taking a psychological interview as the criterion variable, was the total HADS score. This test is brief, simple and well accepted by patients; it is easy to implement within a thoracic surgery service and has a good diagnostic accuracy

Implementing a distress screening program in a thoracic surgery service. / Implementación de un programa de cribado del malestar emocional en un servicio de cirugía torácica.

INTRODUCTION: The aim of the present study was to examine the diagnostic accuracy of screening tests in detecting cases requiring psychological intervention among patients referred for thoracic surgery. METHODS: Emotional distress was evaluated in 105 patients referred for thoracic surgery by means of a diagnostic psychological interview (criterion variable). The screening ability of the following methods was analyzed: the physician's opinion (Yes/No), Hospital Anxiety and Depression Scale (HADS), single-item interview: «Are you depressed?¼ (Depression Question, ADEP) (1-5) and the single-item interview: «Are you anxious?¼ (Anxiety Question, ANXQ) (1-5). RESULTS: According to the clinical interview, 34% of the patients were clinical cases requiring psychological intervention. The total HADS (cut-off point of 10) showed a sensitivity=0.89, specificity=0.75 and AUC=0.883; the ADEP scale (>1) showed a sensitivity=0.79, specificity=0.74 and AUC=0.795; the ANXQ scale (>1) showed a sensitivity=0.78, specificity=0.41 and AUC=0.690; and the physician's opinion showed a sensitivity=0.47 and specificity=0.86. CONCLUSIONS: A high percentage of patients referred for thoracic surgery required psychological intervention. The best instrument to identify those patients requiring psychological care, taking a psychological interview as the criterion variable, was the total HADS score. This test is brief, simple and well accepted by patients; it is easy to implement within a thoracic surgery service and has a good diagnostic accuracy.