Patient and Healthcare Professional Insights of Home- and Remote-Based Clinical Assessment: A Qualitative Study from Spain and Brazil to Determine Implications for Clinical Trials and Current Practice.

INTRODUCTION: The SARS-CoV-2 virus pandemic has accelerated the growing trend towards using home- and remote-based medical testing (H/RMT). The aim of this study was to gather insights and explore the opinions of patients and healthcare professionals (HCPs) in Spain and Brazil regarding H/RMT and the impact of decentralised clinical trials. METHODS: This qualitative study consisted of in-depth open question interviews of HCPs and patients/caregivers followed by a workshop that aimed to determine the advantages and barriers to H/RMT in general, and in the context of clinical trials. RESULTS: There were 47 participants in the interviews (37 patients, 2 caregivers, 8 HCPs) and 32 in the validation workshops (13 patients, 7 caregivers, 12 HCPs). The main advantages for the use of H/RMT in current practice were the comfort and convenience, the ability to improve the relationship between HCPs and patients and personalise patient care, and the increased patient awareness towards their disease. Barriers to H/RMT included accessibility, digitalisation, and the training requirements for both HCPs and patients. Furthermore, according to the Brazilian participants, there is a general distrust in the logistical management of H/RMT. Patients indicated that the convenience of H/RMT did not influence their decision to participate in a clinical trial, with the main reason for participating in a clinical trial being to improve health; however, H/RMT in clinical research does aid adherence to the long-term follow-up associated with trials and provides access to patients living far from the clinical sites. CONCLUSION: Insights from patients and HCPs suggest that the advantages of H/RMT may outweigh the barriers, and that social, cultural and geographical factors and the HCP-patient relationship are critical aspects to be considered. Moreover, the convenience of H/RMT does not appear to be a driver for participating in a clinical trial but can facilitate patient diversity and study adherence.

Development and Validation of Patient-Reported Outcome Measures (PROM) and Patient-Reported Experience Measures (PREM) in Home Respiratory Therapies: Oxygen Therapy, CPAP Treatment, Mechanical Ventilation, and Aerosol Therapy.

Introduction: Home respiratory therapies (HRT) are treatments aimed at diseases that are generally chronic and that have a significant impact on the biopsychosocial aspects of patients' lives. No validated patient-reported outcome measures (PROM) and patient-reported experience measures (PREM) are available to assess the impact of these treatments on quality of life (QoL) in HRT. The objective of this work was to identify and validate PROMs and PREMs in HRT. Methods: The process was divided into 5 stages: review of the literature, patient interviews, qualitative validation workshops, cognitive validation, and psychometric validation. For the identification of PROM and PREM, consensus techniques were used with patients, caregivers, specialist doctors, and therapists. The evaluation was based on items that were collected from questionnaires on diseases commonly treated with HRT techniques in clinical practice. The psychometric validation was analyzed by a team of psychologists trained in the methodology. Results: For the literature review, 20 articles met the inclusion and exclusion criteria. After patient interviews, the research team selected 40 PROM items for each treatment from the total of 51 PROM questionnaires found for respiratory diseases. For the validation workshops, the list of selected items had to be reduced to a final number of 15. After the workshops, 8 preliminary questionnaires were drawn up (4 PROMs and 4 PREMs). A second validation round was then held and the questionnaires were modified with the list of PREMs and PROMs resulting from the whole process. The psychometric validation of PROM and PREM questionnaires for each of the therapies consisted of an exploratory factor analysis (EFA) and a confirmatory factor analysis (CFA). Overall, 1299 questionnaires answered by 650 patients were obtained. Conclusions: A preliminary set of PREMs and PROMs associated with HRT with good reliability indexes was developed: Cronbach's alpha and Composite Reliability Index (CRI). These are questionnaires with a 5-point Likert scale that the patient can quickly complete and which provide excellent scores for acceptability, reliability, and validity in psychometric tests. This may offer HRT units a robust basis for better monitoring of patient outcomes and needs and improve healthcare quality and clinical outcomes.

Introducción: Las terapias respiratorias domiciliarias (TRD) son tratamientos dirigidos a patologías, generalmente crónicas, que tienen un impacto significativo en los aspectos biopsicosociales de la vida del paciente. No hay PROM y PREM validados informados por los pacientes para evaluar el impacto de los tratamientos en sí mismos en la calidad de vida (CdV) en la TRD. El objetivo de este trabajo es identificar y validar las PROM y PREM en las TRD. Métodos: Se ha realizado un proceso de cinco etapas: investigación bibliográfica, entrevistas a pacientes, talleres de validación cualitativa, validación cognitiva y validación psicométrica. Para la identificación de PRO y PRE se utilizaron técnicas de consenso con pacientes, cuidadores, médicos especialistas y terapeutas. Se basó en ítems recogidos de cuestionarios relacionados con patologías prevalentes tratadas con TRD y que se utilizan en la práctica clínica. Para la validación psicométrica, un equipo de psicólogos metodólogos realizó los análisis. Resultados: Para la revisión bibliográfica, 20 artículos cumplieron con los criterios de inclusión y exclusión. Después de las entrevistas con los pacientes, el equipo de investigación seleccionó 40 ítems PRO para cada terapia de un total de 51 cuestionarios PRO encontrados para enfermedades respiratorias. Con los talleres de validación se tuvo que reducir la lista de ítems seleccionados a una lista final de 15. Después de los talleres se realizaron 8 cuestionarios preliminares (4 PRO y 4 PRE). Luego de una segunda validación, los cuestionarios fueron modificados con la lista de PRE y PRO resultante de todo el proceso. La validación psicométrica de los cuestionarios PROM y PREM en cada una de las terapias consistió en un análisis factorial exploratorio (EFA) y un análisis factorial confirmatorio (AFC). Se obtuvieron 1.299 cuestionarios respondidos por 650 pacientes. Conclusiones: Se ha desarrollado un primer conjunto de PREM y PROM relacionados con la TRD, con buenos índices de fiabilidad: alfa de Cronbach y Composite Reliability Index (CRI). Se trata de cuestionarios con una escala de 5 puntos Likert que el paciente puede completar rápidamente con excelentes puntuaciones de aceptabilidad, fiabilidad y validez en las pruebas psicométricas. Los servicios de TRD ahora podrían tener una base para un mejor seguimiento de los resultados y las necesidades de los pacientes y, por lo tanto, para mejorar la calidad de la atención médica y los resultados clínicos.

Relationship between serum dioxin-like polychlorinated biphenyls and post-testicular maturation in human sperm.

The relationship between dioxin-like polychlorinated biphenyl (DL-PCB) levels in serum and semen parameters were investigated. Our case-control included two groups of patients. Total concentrations of PCBs were significantly higher in the low semen quality (n=24) than in the normal semen quality (n=26) group. A significant negative correlation was found between PCB 126 and viability in men with low semen quality, while PCBs 77 and 81 were positively correlated with morphology, and PCB 118, mono-ortho and total DL-PCBs were positively correlated with volume. In the normal semen quality group, PCB 189 and 118 were negatively correlated with sperm motility and volume, respectively. In addition, positive significant correlations were found between PCB 77, 23 and total non-ortho PCBs with regard to morphology. Our findings suggest that sperm motility, viability, volume and morphology are parameters sensitive to alteration by exposure to DL-PCBs, although PCB effects on spermatogenesis were not of clinical significance.