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In June 2021, the US Food and Drug Administration (FDA) released a draft guidance for industry on core patient-reported outcomes (PROs) and related considerations for instrument selection and trial design in registrational cancer clinical trials, building on prior communications about the use of PROs to assess efficacy and tolerability in oncology drug development. The International Society for Quality of Life Research (ISOQOL) Standards and Best Practices Committee led an initiative to draft a commentary about the guidance, focusing on its positive aspects and areas that would benefit from additional clarification and consideration. For comprehensiveness, the authors reviewed existing public comments on the draft guidance, and the commentary underwent a thorough review process through three ISOQOL Special Interest Groups (Psychometrics, Clinical Practice, and Regulatory and Health Technology Assessment Engagement) followed by the ISOQOL Board. The goal of this commentary is to situate this new and relevant guidance document within the context of recent regulatory efforts on PROs and highlight areas in which further work may ultimately benefit the field.
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Neoplasias , Qualidade de Vida , Estados Unidos , Humanos , Qualidade de Vida/psicologia , United States Food and Drug Administration , Medidas de Resultados Relatados pelo Paciente , Neoplasias/tratamento farmacológico , OncologiaRESUMO
BACKGROUND: The COVID-19 pandemic was declared a public health emergency in March 2020. The British National Health Service (NHS) redirected medical attention towards prioritising COVID-19-positive patients in favour of less urgent care affecting cancer service provision. This study aims to explore experiences of healthcare professionals (HCPs) and investigate the impact of COVID-19 on decision-making in surgical oncology. METHODS: HCPs with experience in surgical oncology were recruited from January 2021 to June 2021. Qualitative semi-structured telephone interviews were conducted and transcribed verbatim. Interviews were conducted until data saturation. Thematic analysis was used to identify frequently discussed themes. RESULTS: A total of 13 participants were interviewed, identifying three main pandemic-related challenges: multi-disciplinary team (MDT) processes - telephone pre-operative assessments impoverished information elicited from in-person examination; service delivery - personal protective equipment (PPE) added complexity to surgical practice and more difficult communication; work routines - increased workload to deliver COVID-safe remote practices and decreased training time. CONCLUSIONS: COVID-19 influenced cancer service provision with teams making significant changes to ensure that effective clinical reasoning and surgical standards were maintained. Managing safe COVID-19 surgical care impacted daily-life and work stressors. Post crisis, service delivery is looking to integrate telemedicine within care whilst reducing its impact on workload and in-practice training.
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COVID-19 , Neoplasias , Oncologia Cirúrgica , Humanos , COVID-19/epidemiologia , Pandemias , Medicina Estatal , Atenção à SaúdeRESUMO
BACKGROUND: Patient-reported outcomes are critical for obtaining valuable patient insight into different surgical treatment options with comparable clinical outcomes. This study aimed to compare early postoperative patient-reported symptoms and functioning between thoracoscopic segmentectomy and lobectomy for small-sized (≤ 2 cm) peripheral non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: This study included 110 patients who underwent thoracoscopic segmentectomy or lobectomy for peripheral NSCLC ≤ 2 cm in a multicenter prospective longitudinal study (CN-PRO-Lung 1). Symptom severity, functional status, and short-term clinical outcomes were compared between the groups. Symptom severity and functional status were measured using the MD Anderson Symptom Inventory-Lung Cancer at baseline, daily post-surgery, and weekly post-discharge for up to 4 weeks. Both the proportion of moderate-to-severe scores and mean scores on a 0-10 scale were compared between the groups. RESULTS: Overall, 48 and 62 patients underwent thoracoscopic segmentectomy and lobectomy, respectively. No significant between-group differences were found in the severity of the top five symptoms (coughing, shortness of breath, pain, fatigue, and disturbed sleep) or in the impairment of all six function items (work, walking, general activity, enjoyment of life, mood, and relations with others) during both the 6-day postoperative hospitalization and the 4-week post-discharge (all p > 0.05). Short-term clinical outcomes of postoperative hospital stay, operative time, drainage time, postoperative in-hospital oral morphine equivalent dose, and complication rate were also comparable (all p > 0.05). CONCLUSIONS: In patients with peripheral NSCLC ≤ 2 cm, thoracoscopic segmentectomy and lobectomy might produce comparable symptom burden and functional impairment during the early postoperative period.
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Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Assistência ao Convalescente , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Humanos , Estudos Longitudinais , Neoplasias Pulmonares/cirurgia , Alta do Paciente , Medidas de Resultados Relatados pelo Paciente , Pneumonectomia , Período Pós-Operatório , Estudos ProspectivosRESUMO
INTRODUCTION: Primary spontaneous pneumothorax (PSP) is a relatively common disease. Different studies have been published but lung resection, when no emphysema-like changes (ELC) are detected, is unclear. The aim of our study is to retrospectively investigate the role of lung resection of the apex of the lung in patients with no ELC. METHODS: This is a retrospective multicenter study of 516 patients who underwent surgical treatment of PSP with no ELC between January 2007 and December 2017. Patients were divided into two groups: pleurodesis alone group, only mechanical pleurodesis performed (53 patients), and apical resection group, apical resection of the lung and mechanical pleurodesis performed (463 patients). The following were the primary end points considered: recurrence rate and perioperative complications; the following were the secondary end points considered: length of stay, chest tube removal, residual pleural space, prolonged air leak, and reoperation rate. RESULTS: No differences were found in the baseline and operative characteristics of the two groups. Both primary end points were statistically different: recurrence rate (15.1% versus 6.5%, P = 0.023) and perioperative complications (18.9% versus 7.3%, P = 0.004). Among secondary end points length of stay (6.94 versus 5.55, P = 0.033) and prolonged air leak (15.1% versus 4.3%, P = 0.001) were statistically different. On multivariate analysis, lung resection emerged as a protective factor for recurrence (hazard ratio 0.182, P < 0.001). CONCLUSIONS: In our experience, apical lung resection in patients without ELC may reduce recurrence rate and perioperative complications when compared with pleurodesis alone.
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Pneumotórax , Enfisema Pulmonar , Humanos , Pneumotórax/etiologia , Pneumotórax/cirurgia , Estudos Retrospectivos , Vesícula , Recidiva Local de Neoplasia , Pleurodese , Pulmão , Enfisema Pulmonar/cirurgia , Recidiva , Cirurgia Torácica Vídeoassistida , Resultado do TratamentoRESUMO
BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) assesses quality of life (QOL) in patients with lung cancer and was the first EORTC module developed for use in international clinical trials. Since its publication in 1994, major treatment advances with possible effects on QOL have occurred. These changes called for an update of the module and its international psychometric validation. We aimed to investigate the scale structure and psychometric properties of the updated lung cancer module, QLQ-LC29, in patients with lung cancer. METHODS: This international, observational field study was done in 19 hospitals across 12 countries. Patients aged older than 18 years with a confirmed diagnosis of lung cancer and no other previous primary tumour, and who were mentally fit with sufficient language skills to understand and complete the questionnaire were included. Patients were asked during a hospital visit to fill in the paper versions of the core questionnaire EORTC QLQ-C30 plus QLQ-LC29, and investigators selected half of these patients to complete the questionnaire again 2-4 weeks later. Our primary aim was to assess the scale structure and psychometric properties of EORTC QLQ-LC29. We analysed scale structure using confirmatory factor analysis; reliability using Cronbach's α value (internal consistency) and intra-class coefficient (test-retest reliability); sensitivity using independent t tests stratified by Karnofsky performance status; and responsiveness to change over time by ANOVA. This study is registered with ClinicalTrials.gov, NCT02745691. FINDINGS: Between April 12, 2016, and Sept 26, 2018, 523 patients with a confirmed diagnosis of either non-small-cell lung cancer (n=442) or small-cell lung cancer (n=81) were recruited. Confirmatory factor analysis provided a solution composed of five multi-item scales (coughing, shortness of breath, fear of progression, hair problems, and surgery-related symptoms) plus 15 single symptom or side-effect items: χ2=370·233, root mean square error of approximation=0·075, and comparative-fit index=0·901. Cronbach's α for internal consistencies of all multi-item scales were above the threshold of 0·70. Intra-class coefficients for test-retest reliabilities ranged between 0·82 and 0·97. Three (shortness of breath, fear of progression, and hair problems) of the five multi-item scales showed responsiveness to change over time (p values <0·05), as did nine of 15 single symptom items. Four (coughing, shortness of breath, fear of progression, and surgery-related symptoms) of the five multi-item scales and ten of the 15 single symptom items were sensitive to known group differences (ie, lower vs higher Karnofsky performance status). INTERPRETATION: Results determined the psychometric properties of the updated lung cancer module, which is ready for use in international clinical studies. FUNDING: EORTC Quality of Life Group.
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Carcinoma Pulmonar de Células não Pequenas/psicologia , Psicometria , Carcinoma de Pequenas Células do Pulmão/psicologia , Idoso , Carcinoma Pulmonar de Células não Pequenas/epidemiologia , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma Pulmonar de Células não Pequenas/terapia , Feminino , Humanos , Idioma , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Carcinoma de Pequenas Células do Pulmão/epidemiologia , Carcinoma de Pequenas Células do Pulmão/patologia , Carcinoma de Pequenas Células do Pulmão/terapia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: In early-stage Non-Small Cell Lung Cancer (NSCLC) patients, little is known about how to measure patient participation in Shared-Decision Making (SDM). We examined the psychometric properties and clinical acceptability of the Decision Self-Efficacy scale (DSE) in a cohort of patients undergoing to Stereotactic Ablative Radiotherapy (SABR) or Video-assisted Thoracoscopic Surgery (VATS) to capture patient involvement in treatment decisions. METHODS: In the context of a prospective longitudinal study (Life after Lung Cancer-LiLAC) involving 244 patients with early-stage NSCLC, 158 (64.7%) patients completed the DSE either on paper or electronically online prior to treatment with SABR or VATS pulmonary resection. DSE psychometric properties were examined using: principal components analysis of item properties and internal structure, and internal construct validity; we also performed a sensitivity analysis according to Eastern Cooperative Oncology Group Performance Status (ECOG PS), gender, age and treatment received (VATS or SABR) difference. RESULTS: Exploratory factor analysis using polychoric correlations substantiated that the 11 item DSE is one scale accounting for 81% of the variance. We calculated a value of 0.96 for Cronbach's alpha for the total DSE score. DSE scores did not differ by gender (p = 0.37), between the two treatment groups (p = 0.09) and between younger and older patients (p = 0.4). However, patients with an ECOG PS > 1 have a DSE mean of 73.8 (SD 26) compared to patients with a PS 0-1 who have a DSE mean of 85.8 (SD 20.3 p = 0.002). CONCLUSION: Findings provide preliminary evidence for the reliability and validity of the DSE questionnaire in this population. However, future studies are warranted to identify the most appropriate SDM tool for clinical practice in the lung cancer treatment field.
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Carcinoma Pulmonar de Células não Pequenas/psicologia , Tomada de Decisão Compartilhada , Neoplasias Pulmonares/psicologia , Medidas de Resultados Relatados pelo Paciente , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/terapia , Análise Fatorial , Feminino , Humanos , Estudos Longitudinais , Neoplasias Pulmonares/terapia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Radiocirurgia/efeitos adversos , Reprodutibilidade dos Testes , Cirurgia Torácica Vídeoassistida/efeitos adversosRESUMO
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) covers 13 typical symptoms of lung cancer patients and was the first module developed in conjunction with the EORTC core quality-of-life (QL) questionnaire. This review investigates how the module has been used and reported in cancer clinical trials in the 20 years since its publication. Thirty-six databases were searched with a prespecified algorithm. This search plus an additional hand search generated 770 hits, 240 of which were clinical studies. Two raters extracted data using a coding scheme. Analyses focused on the randomized controlled trials (RCTs). Of the 240 clinical studies that were identified using the LC13, 109 (45%) were RCTs. More than half of the RCTs were phase 3 trials (n = 58). Twenty RCTs considered QL as the primary endpoint, and 68 considered it as a secondary endpoint. QL results were addressed in the results section of the article (n = 89) or in the abstract (n = 92); and, in half of the articles, QL results were presented in the form of tables (n = 53) or figures (n = 43). Furthermore, QL results had an impact on the evaluation of the therapy that could be clearly demonstrated in the 47 RCTs that yielded QL differences between treatment and control groups. The EORTC QLQ-LC13 fulfilled its mission to be used as a standard instrument in lung cancer clinical trials. An update of the LC13 is underway to keep up with new therapeutic trends and to ensure optimized and relevant QL assessment in future trials.
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Neoplasias Pulmonares , Qualidade de Vida , Ensaios Clínicos como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e Questionários/estatística & dados numéricosRESUMO
OBJECTIVES: Our goal was to evaluate gender representation among session leaders and abstract presenters at European cardio-thoracic surgical annual meetings. METHODS: We did a descriptive study of the gender distribution among session leaders and abstract presenters at 2 European cardio-thoracic international meetings from 2017 to 2022. Data from publicly available programmes were used to generate a list of session leaders and abstract presenters. The primary outcome was to evaluate the proportion of female sessions leaders at the annual meetings. Descriptive analyses were performed including the Cochran-Armitage trend test for linear trend of proportions. RESULTS: A total of 1025 sessions of 11 annual meetings of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society of Thoracic Surgeons were examined. A total of 397 (13.2%) out of 3007 total session leaders and 955 (15.2%) out of 6251 abstract presenters were female. From 2017 to 2022, the proportions of both female session leaders and abstract presenters trended significantly [10.4% to 21.9% (P < 0.001) and 13.7% to 18.3% (P < 0.001), respectively]. The EACTS female members and female meeting attendees significantly increased from 2017 to 2022 [11.1% to 15.9% (P < 0.001) and 23.7% to 26.9% (P < 0.001)], respectively. Most of the women attendees at the EACTS and the European Society of Thoracic Surgeons meetings who were session leaders and speakers came from Germany, Italy, the United Kingdom and the United States. CONCLUSIONS: Women are under-represented compared to men in leadership and speaking roles at European cardio-thoracic surgical annual meetings. In the past few years, an encouraging positive trend over time for female leadership roles has been noted; as a result, the proportion of female society members is represented at the annual meetings. However, a substantial gender gap still exists in leading roles of meeting attendees.
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Cirurgiões , Cirurgia Torácica , Procedimentos Cirúrgicos Torácicos , Masculino , Humanos , Feminino , Estados Unidos , Sociedades Médicas , Reino UnidoRESUMO
Background: Dyspnoea is common following surgical resection for non-small cell lung cancer (NSCLC). The effects range from reduced quality of life to impact on adjuvant therapy outcomes. Currently, dyspnoea beyond the immediate postoperative phase and risk factors are not well characterised. We hope to assess the evolution of patient-reported dyspnoea after anatomic lung resection and associated factors. Methods: Single-centre cohort study with analysis on data collected longitudinally of 131 patients undergoing anatomic lung resections for NSCLC between September 2014 and December 2018. The European Organization for Research and Treatment Lung Cancer-specific Quality of Life Questionnaire Dyspnoea Scale was used to measure dyspnoea before and after surgery. Multivariable regression analysis was used to identify factors associated with clinically meaningful perioperative changes in dyspnoea at 6-12 months. Results: Mean Dyspnoea Scale scores preoperatively and 6-12 months after resection were 12.6 (standard deviation 17.4) and 17.9 (standard deviation 20.5), respectively. Of all patients 31% experienced a clinically meaningful increase in dyspnoea, defined as >10 points between Dyspnoea Scale scores preoperatively and at 6-12 months. Comparatively, 71% of patients without preoperative symptoms of dyspnoea developed a clinically meaningful increase of dyspnoea postoperatively. After adjusting the analysis for baseline factors and preoperative Dyspnoea Scale score, female sex remained the only patient factor associated with increased postoperative dyspnoea at 6-12 months after surgery (P=0.046). A total of 34% of patients reported increased dyspnoea after lobectomies and 9% after segmentectomies (P=0.014). Segmentectomy (as opposed to larger resections) was the only surgical factor associated with lower risk of increased dyspnoea (P=0.057). Conclusions: A clinically meaningful increase in dyspnoea is frequent after lung resection. Postoperative evolution of dyspnoea is non-predictable using objective baseline factors highlighting the importance of patient reported symptoms and involvement in clinical consultation.
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Patients with curable non-surgical lung cancer are often current smokers, have co-existing medical comorbidities and are treated with curative radiotherapy. To maximise the benefits of modern radiotherapy, there is an urgent need to optimise the patient's health to improve survival and quality of life. METHODS AND ANALYSIS: The Yorkshire Cancer Research-funded Prehabilitation Radiotherapy Exercise, smoking Habit cessation and Balanced diet Study (PREHABS) (L426) is a single-centre prospective feasibility study to assess embedding behavioural changes into the radical radiotherapy pathway of patients with lung cancer. Feasibility will be assessed by measuring acceptability, demand and implementation. The duration of the study is 24 months. PREHABS has two workstreams: the intervention study and the theory of change (ToC) study.Intervention study: PREHABS will commence at the R-IDEAL phase 2 trial (exploratory) based on existing evidence and includes support for smoking cessation, increasing activity and dietary well-being. Patients undergoing radical radiotherapy for lung cancer will be recruited from the oncology department at Leeds Teaching Hospitals NHS Trust (LTHT). ToC study: to maximise the acceptability and adherence to the PREHABS, we will use a ToC approach to qualitatively explore the key barriers and enablers of implementing a tailored programme of 'prehabilitation'. The PREHABS ToC study participants will be recruited from patients with lung cancer undergoing radical radiotherapy and staff from the LTHT oncology department. ANALYSIS: The primary endpoint analysis will report the number of participants and adherence to the study interventions. Secondary endpoints include continued engagement with study interventions post-treatment. The analysis will focus on descriptive statistics. Thematic analysis of the qualitative data from the ToC study will identify consensus on intervention optimisation and delivery. ETHICS AND DISSEMINATION: On 12 May 2021, the Cambridge East Ethics Committee granted ethical approval (21/EE/0048). The study is registered in the National Institute for Health and Care Research (NIHR) portfolio. The results will be disseminated through publication in peer-reviewed scientific journals and presented at conferences. TRIAL REGISTRATION NUMBER: NIHR portfolio 48420.
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Neoplasias Pulmonares , Humanos , Procedimentos Clínicos , Dieta , Estudos de Viabilidade , Neoplasias Pulmonares/radioterapia , Exercício Pré-Operatório , Estudos Prospectivos , Qualidade de Vida , Fumar Tabaco , Ensaios Clínicos Fase II como AssuntoRESUMO
The treatment landscape of resectable early-stage non-small cell lung cancer (NSCLC) is transforming due to the approval of novel adjuvant and neoadjuvant systemic treatments. The European Medicines Agency (EMA) recently approved adjuvant osimertinib, adjuvant atezolizumab, adjuvant pembrolizumab, and neoadjuvant nivolumab combined with chemotherapy, and the approval of other agents or new indications may follow soon. Despite encouraging results, many unaddressed questions remain. Moreover, the transformed treatment paradigm in resectable NSCLC can pose major challenges to healthcare systems and magnify existing disparities in care as differences in reimbursement may vary across different European countries. This Viewpoint discusses the challenges and controversies in resectable early-stage NSCLC and how existing inequalities in access to these treatments could be addressed.
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The treatment landscape of resectable early-stage non-small cell lung cancer (NSCLC) is set to change significantly due to encouraging results from randomized trials evaluating neoadjuvant and adjuvant immunotherapy, as well as adjuvant targeted therapy. As of January 2024, marketing authorization has been granted for four new indications in Europe, and regulatory approvals for other study regimens are expected. Because cost-effectiveness and reimbursement criteria for novel treatments often differ between European countries, access to emerging developments may lead to inequalities due to variations in recommended and available lung cancer care throughout Europe. This Series paper (i) highlights the clinical studies reshaping the treatment landscape in resectable early-stage NSCLC, (ii) compares and contrasts approaches taken by the European Medicines Agency (EMA) for drug approval to that taken by the United States Food and Drug Administration (FDA), and (iii) evaluates the differences in access to emerging treatments from an availability perspective across European countries.
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Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported superior symptom control of electronic patient-reported outcome (ePRO)-based symptom management after lung cancer surgery for up to 1 month postdischarge. Here, we present the long-term results (1-12 months) of this multicenter, randomized trial, where patients were assigned 1:1 to receive postoperative ePRO-based symptom management or usual care daily postsurgery, twice weekly postdischarge until 1 month, and at 3, 6, 9, and 12 months postdischarge. Long-term patient-reported outcomes were assessed with MD Anderson Symptom Inventory-Lung Cancer module. Per-protocol analyses were performed with 55 patients in the ePRO group and 57 in the usual care group. At 12 months postdischarge, the ePRO group reported significantly fewer symptom threshold events (any of the five target symptom scored ≥4; median [IQR], 0 [0-0] v 0 [0-1]; P = .040) than the usual care group. From 1 to 12 months postdischarge, the ePRO group consistently reported significantly lower composite scores for physical interference (estimate, -0.86 [95% CI, -1.32 to -0.39]) and affective interference (estimate, -0.70 [95% CI, -1.14 to -0.26]). Early intensive ePRO-based symptom management after lung cancer surgery reduced symptom burden and improved functional status for up to 1 year postdischarge, supporting its integration into standard care.
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Neoplasias Pulmonares , Medidas de Resultados Relatados pelo Paciente , Humanos , Neoplasias Pulmonares/cirurgia , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Qualidade de VidaRESUMO
BACKGROUND: Patient satisfaction reflects the perception of the customer about the level of quality of care received during the episode of hospitalization. OBJECTIVE: To compare the levels of satisfaction of patients submitted to lung resection in two different thoracic surgical units. METHODS: Prospective analysis of 280 consecutive patients submitted to pulmonary resection for neoplastic disease in two centers (center A: 139 patients; center B: 141 patients; 2009-2010). Patients' satisfaction was assessed at discharge through the EORTC-InPatSat32 module, a 32-item, multi-scale self-administered anonymous questionnaire. Each scale (ranging from 0 to 100 in score) was compared between the two units. Multivariable regression and bootstrap were used to verify factors associated with the patients' general satisfaction (dependent variable). RESULTS: Patients from unit B reported a higher general satisfaction (91.5 vs. 88.3, p = 0.04), mainly due to a significantly higher satisfaction in the doctor-related scales (doctors' technical skill: p = 0.001; doctors' interpersonal skill: p = 0.008; doctors' availability: p = 0.005, and doctors information provision: p = 0.0006). Multivariable regression analysis and bootstrap confirmed that level of care in unit B (p = 0.006, bootstrap frequency 60%) along with lower level of education of the patient population (p = 0.02, bootstrap frequency 62%) were independent factors associated with a higher general patient satisfaction. CONCLUSION: We were able to show a different level of patient satisfaction in patients operated on in two different thoracic surgery units. A reduced level of patient satisfaction may trigger changes in the management policy of individual units in order to meet patients' expectations and improve organizational efficiency.
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Neoplasias Pulmonares/cirurgia , Satisfação do Paciente/estatística & dados numéricos , Idoso , Competência Clínica , Escolaridade , Feminino , Unidades Hospitalares , Humanos , Masculino , Análise Multivariada , Relações Médico-Paciente , Estudos Prospectivos , Inquéritos e QuestionáriosRESUMO
Thymomas are rare epithelial tumors of the mediastinum with relatively good prognosis compared to other thoracic malignancies. Surgery is considered the best treatment and the most important determinant of long-term survival even in advanced stages. Nevertheless, complete resection may be challenging and require a multimodality approach. We present a case of a stage IVa thymoma surgically treated. The superior vena cava was completely occluded and, after resection, reconstruction was deemed unnecessary due to sufficient venous return through the azygos-inferior vena cava system. In our opinion, despite the morbidity of surgery in advanced thymomas, it should always be considered in expert hands.
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BACKGROUND: We investigated the association between preoperative quality of life and long-term survival in patients undergoing surgical resection for non-small cell lung cancer. METHODS: Retrospective analysis was conducted on 388 consecutive patients who completed the quality of life assessment through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and lung cancer specific module (LC13), before anatomic lung resection for non-small cell lung cancer (2014-2018). Survival distribution was estimated by the Kaplan-Meier method. Cox proportional hazards regression and competing risk regression analyses were used to assess the independent association of preoperative patient-reported outcomes with overall and cancer-specific survival. RESULTS: Higher score in patient-reported physical functioning was significantly associated with longer overall survival. Factors significantly associated with poorer overall survival remained older age (P = .005), low body mass index (P = .007), male sex (P < .001), and nodal involvement (P = .007). Competing regression analysis found that worse baseline lung cancer-specific dyspnea (P = .03), low body mass index (P = .01), worse performance status (P = .03), and lymph node involvement (P = .01) were significantly associated with poorer cancer-specific survival. CONCLUSIONS: Higher patient-reported physical function score was associated with longer overall survival after resection. Our study highlights the significance of routinely collecting quality of life data to aid preoperative decision making in non-small cell lung cancer.
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Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Masculino , Neoplasias Pulmonares/patologia , Estudos Retrospectivos , Qualidade de Vida , Pneumonectomia/métodos , Pulmão/patologia , Estadiamento de NeoplasiasRESUMO
Background: Women's participation in the surgical workforce has increased. The aim of the study is to acquire objective data regarding practice, training, satisfaction, and discrimination of women surgeons working in cardiothoracic and vascular surgery in Italy. Methods: An 83-item questionnaire was distributed through social media and sent to e-mails of women surgeons from November through December 2020. A sub-analysis on women working in cardiac, thoracic, and vascular surgery was performed. Results: Overall, 222 respondents were included (48 cardiac, 62 thoracic, and 112 vascular surgeons). Thirty-six percent partially abandoned surgical activities in favor of other professional activities, not including the operating room. On average, our respondents took part in 33% of all surgical cases performed in their units; however, of 12 high complexity surgeries per month, less than one is performed by them. Only 7 female participants who answered the questionnaire were in leadership positions. Many respondents struggle with lack of mentorship and missing opportunities in operating room. A high percentage of women experienced discrimination due to their gender in their professional life, and 59% claimed to have been subject to sexual harassment. Conclusions: In Italy, women thoracic, cardiac, and vascular surgeons face lack of mentorship, opportunities in the operating room, and gender-related issues including some episodes of sexual harassment. Diversity, equity, and inclusion should become strategic priorities in all institutions. Among our respondents, surgical exposure is limited, which may deter a surgical career and play a crucial role in surgeons' dissatisfaction, that also include poor work-life-balance, and a large amount of administrative work. Surgical societies may address these issues by providing structured mentorship programs and networking opportunities. Societies' contributions might substantially impact supporting and retaining women at different stages of their careers.
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INTRODUCTION: Segmentectomy and lobectomy are the main surgical procedures for early-stage lung cancer. However, few studies have analysed patient-reported outcomes after segmentectomy versus lobectomy. This study aims to compare patient-reported outcomes-such as symptoms, daily functioning and quality of life-between thoracoscopic segmentectomy and lobectomy for early-stage lung cancer during the 1 year after surgery. METHODS AND ANALYSIS: Overall, 788 newly diagnosed patients with early-stage lung cancer (tumour size ≤2 cm), who are scheduled to undergo thoracoscopic segmentectomy or lobectomy, will be recruited in this multicentre, prospective cohort study. The patients will receive standardised care after surgery. The Perioperative Symptom Assessment for Lung Surgery-a validated lung cancer surgery-specific scale-will be used to assess the symptoms and functions at baseline, at discharge and monthly after discharge for 1 year. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Lung Cancer module 29 will be used to assess the patients' quality of life at the same time points. The primary outcome will be the shortness of breath scores during the first year after thoracoscopic segmentectomy and lobectomy and will be compared using mixed-effects models. The secondary outcomes will include other symptoms, indicators of daily functioning, quality of life scores and traditional clinical outcomes. These will be compared using mixed-effects models and the Student's t-test, non-parametric test or Χ2 test. Propensity score matching will be used to ensure an even distribution of known confounders between the groups. ETHICS AND DISSEMINATION: The Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital approved this study (approval number: SCCHEC-02-2022-002). All participants will be instructed to provide informed consent. The manuscript is based on protocol version 3.0. The study results will be presented at medical conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR2200060753.
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Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Carcinoma Pulmonar de Células não Pequenas/patologia , Pneumonectomia/métodos , Qualidade de Vida , Estudos Prospectivos , Neoplasias Pulmonares/cirurgia , Neoplasias Pulmonares/patologia , Pulmão/patologia , Medidas de Resultados Relatados pelo Paciente , Estudos Retrospectivos , Estadiamento de Neoplasias , Resultado do Tratamento , Estudos Multicêntricos como AssuntoRESUMO
The symposium Patient-centered care in thoracic care: a holistic approach was held on June 22, 2021, as a virtual event in the context of the European conference on general thoracic surgery. Its aim was to explore how to improve patient outcomes in thoracic surgery by using enhanced recovery after surgery (ERAS®) frameworks and collaboration within healthcare. During the four presentations, topics on patient mobilization and physical rehabilitation, pain management, and the role of chest drainage in facilitating perioperative care were discussed. Strategies to minimize opioid consumption and incorporate patients' experiences as quality indicators were described. There were two main ideas that were considered pivotal to achieve optimal care: (I) the use of simple, easily implementable perioperative protocols and practices to improve compliance from both patients and the healthcare team, and (II) promote a better recovery with early mobilization and reducing the patient's levels of pain. Among the key learnings that emerged from the presentations are the importance of taking the patient's experiences into account, including what they value the most after surgery, and how technology can enable better care. The use of digital chest drainage systems emerged as a way for improving patient outcomes and experiences across several key indicators.