Adaptation and validation into Spanish of a specific questionnaire on quality of life in patients with tracheostomy (TQOL).

BACKGROUND AND OBJECTIVE: A long-term tracheostomy can have significant negative effects on quality of life because it causes physical, functional, sensory, psychological, social, economic, and work impairments to the life of the individual. The objective of this study was to validate in Spanish a quality-of-life questionnaire for these patients. MATERIALS AND METHODS: A psychometric validation study of a questionnaire in 45 patients over 18 years of age, with tracheostomy for six months, who understand Spanish and have a good understanding of the questions of the SF-36 questionnaire and a specific quality of life questionnaire for the patient with tracheostomy (TQOL-versión española). This Vquestionnaire is a modification and cultural adaptation into Spanish of the original English instrument named Tracheostomy Specific Quality of Life Questionnaire (TQOL). The two questionnaires (TQOL-versión española) and the SF-36 were completed 6 months after the tracheostomy and between 30 and 50 days after the first administration. The reliability, repeatability, and construct validity of the TQOL-versión española were evaluated. The construct validity was assessed by the correlation between the results of the TQOL-versión española and the dimensions of the SF-36 questionnaire. RESULTS: The reliability of the TQOL-versión española measured by Cronbach's alpha coefficient was .814, with variation between items from .783 to .817 in the sample at 6 months and from .794 in the validation sample, with variation between items from .758 to .813. There was intraclass correlation for the total score of the scale using the concordance analysis of Bland-Altman and agreement for the individual questions with the McNemar symmetry test. There was also a good correlation between the scales of the TQOL-versión española and the dimensions of the S-F36. CONCLUSIONS: The TQOL-versión española showed good reliability, repeatability, and construct validity, therefore it is a useful tool to assess the impact on individual patients with a tracheostomy in place for more than 6 months, and to establish strategies at the healthcare and social levels to improve the quality of daily life.

Therapy-Induced Modulation of the Tumor Microenvironment: New Opportunities for Cancer Therapies.

Advances in immunotherapy have achieved remarkable clinical outcomes in tumors with low curability, but their effects are limited, and increasing evidence has implicated tumoral and non-tumoral components of the tumor microenvironment as critical mediators of cancer progression. At the same time, the clinical successes achieved with minimally invasive and optically-guided surgery and image-guided and ablative radiation strategies have been successfully implemented in clinical care. More effective, localized and safer treatments have fueled strong research interest in radioimmunotherapy, which has shown the potential immunomodulatory effects of ionizing radiation. However, increasingly more observations suggest that immunosuppressive changes, metabolic remodeling, and angiogenic responses in the local tumor microenvironment play a central role in tumor recurrence. In this review, we address challenges to identify responders vs. non-responders to the immune checkpoint blockade, discuss recent developments in combinations of immunotherapy and radiotherapy for clinical evaluation, and consider the clinical impact of immunosuppressive changes in the tumor microenvironment in the context of surgery and radiation. Since the therapy-induced modulation of the tumor microenvironment presents a multiplicity of forms, we propose that overcoming microenvironment related resistance can become clinically relevant and represents a novel strategy to optimize treatment immunogenicity and improve patient outcome.