Early Incorporation to Palliative Care (EPC) in Patients With Advanced Non-Small Cell Lung Cancer: The PACO Randomized Clinical Trial.

BACKGROUND: Patients with non-small cell lung cancer (NSCLC) experience a considerable disease burden, evident in symptomatic and psychological spheres. Advanced cancer represents a complex scenario for patients and the healthcare team. Early palliative care (EPC) has been proven as a clinically meaningful strategy in this context by several randomized trials but not in a resource-limited setting. This study aimed to evaluate the effect of EPC compared with standard oncological care (SOC) in patients with metastatic NSCLC in Mexico. MATERIALS AND METHODS: A prospective, randomized clinical trial was conducted at Instituto Nacional de Cancerologia in Mexico. All patients had histologically confirmed metastatic NSCLC without previous treatment. Patients were randomly assigned (1:1) to receive SOC or SOC + EPC. The EPC group was introduced to the palliative care team at baseline after randomization, which was integrated by psychologists, bachelor's in nutrition, specialized nurses, and physicians. Patients randomized to this arm had programmed visits to meet with the team at baseline and through the 2nd, 4th-, and 6th cycles thereafter. The primary endpoint was overall survival (OS); secondary outcomes included quality of life (QoL), anxiety and depression, and symptom intensity. They were assessed using the instruments EORTC QLQ-C30 questionnaire, Edmonton Symptom Assessment Scale (ESAS), and the Hospital Anxiety and Depression Scale (HADS) (clinicaltrials.gov [NCT01631565]). Questionnaires were completed at baseline, at 2nd, 4th, and 6th cycles of treatment. RESULTS: Between March 2012 and June 2015, 201 patients were assessed for eligibility and 146 were enrolled and allocated to receive EPC (73) or SOC (73). Median OS for patients in the EPC vs SOC arm was 18.1 months (95% CI, 7.9-28.4) and 10.5 months (95% CI, 4.7-16.2) (P = .029). Having a poor performance status (HR 1.7 [1.2-2.5]; P = .004) and allocation to the control group (HR 1.5 [1.03-2.3]; P = .034) were independently associated with a worse OS. Those patients with a global QoL > 70 at baseline had a better OS if they were In the EPC arm (38.7 months (95% CI, 9.9-67.6) vs SOC 21.4 months (95% CI, 12.4-30.3)). Mean QoL had a numerical improvement in patients allocated to EPC after 6 cycles of follow-up, nonetheless this difference was not statistically significant (55.1 ±â€…23.7 vs 56.9 ±â€…25.3; P = .753). There were no significant differences in anxiety and depression at all study points. CONCLUSIONS: EPC is associated with a significant improvement in OS, although, we observed that the greatest benefit of providing EPC was observed in those with a global QoL > 70 at baseline. This study did not identify significant changes in terms of QoL or symptom burden between the study groups after follow-up. Evidence robustly suggests that EPC should be considered part of the multidisciplinary treatment of metastatic NSCLC patients since diagnosis. According to our study, EPC can be implemented in low- or middle-income countries (LMIC).

Integration of the geriatric palliative care in oncological care of elderly patient with cancer.

OBJECTIVES: The objective of this article is to describe the profile of the population attended to by the palliative geriatrics clinic and to evaluate the symptomatic control derived from the care provided. METHODS: During 2017 a model based on a holistic approach was implemented, in this model the team geriatric palliative care plays a fundamental role by being part of the palliative care team and functioning as a liaison with the oncology team and other required services. We outlined the profile of 100 patients aged 70 and older seen between 2017 and 2019 at our geriatric palliative care clinic. Descriptive statistics were used. In addition, the symptoms and the care clinic model effect on the symptomatic control were analyzed, as well as the complexity of patients in palliative care with IDC-Pal. RESULTS: The patients median age was 83.5 years. Patients were classified by type of management: 47% within the supportive care group and 53% with palliative care only; 58% had metastatic disease and 84% presented at least 1 comorbidity. Frailty was observed in 78% and a Karnofsky scale of 60 or less was observed in 59% of the overall population. SIGNIFICANCE OF RESULTS: Elderly cancer patients have a complex profile and may have multiple needs. Integrating geriatric palliative care can help to provide better and personalized care along with symptomatic control. Further studies are required to establish the ideal care model for these patients. Importantly, a personalized treatment with a geriatric palliative care specialist is a key element.

Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension.

BACKGROUND: The experience on informed consent form (ICF) readability at the Research Ethics Committee of the National Institute of Cancerology of Mexico (INCan) is described. OBJECTIVE: To evaluate the readability of a randomly-selected sample of ICFs submitted for review between March 1, 2022 and March 31, 2023. The number of pages, the time the reader takes to read the text and the level of education necessary to understand it were determined. RESULTS: More than half the ICFs from internal investigations were shown to be somewhat or very difficult to read; the level of education required to understand them was up to 9.9 years, and the reading time was short. The ICF texts from international multicenter investigations were aimed at an average education level of 5.5 years and had normal readability. Most ICFs from external trials require a reading time of more than 60 minutes per ICF. CONCLUSION: It is necessary to have tools that provide objectivity to the evaluation of ICFs under investigation by ethics committees, which should be indicators of their comprehension, such as readability of the documents.

ANTECEDENTES: Se describe la experiencia sobre la legibilidad de los formatos de consentimiento informado (FCI) del Comité de Ética en Investigación del Instituto Nacional de Cancerología de México. OBJETIVO: Evaluar la legibilidad de una muestra seleccionada aleatoriamente de FCI sometidos para revisión entre el 1 de marzo de 2022 y el 31 de marzo de 2023. Se determinó el número de páginas, el tiempo que el lector invierte para leer el texto y el grado de escolaridad necesario para comprenderlo. RESULTADOS: Más de la mitad de FCI de investigaciones internas mostraron ser algo o muy difíciles de leer, la escolaridad necesaria para comprenderlos fue hasta de 9.9 años y el tiempo de lectura fue corto. Los textos de los FCI de investigaciones internacionales multicéntricas estuvieron dirigidos a un nivel escolar promedio de 5.5 años y tuvieron una legibilidad normal. La mayor parte de los ensayos externos requiere un tiempo de lectura superior a los 60 minutos por FCI. CONCLUSIÓN: Es necesario disponer de herramientas que den objetividad a la evaluación de los FCI en investigación por parte de los comités de ética y sean indicadores de su comprensión, tales como la legibilidad de los documentos.

Role of palliative care intervention in patients with vulvar cancer: a retrospective study.

OBJECTIVE: To describe the experience of a Mexican cancer centre in vulvar cancer and the opportunity to incorporate palliative care (PC) during treatment. PATIENTS AND METHODS: A retrospective study of clinical and sociodemographic characteristics of women with vulvar cancer referred to the PC service (PCS) between 2010 and 2021 is reported. Frequencies were estimated, as well as medians and IQRs, accordingly. Referral time and overall survival were estimated using the Kaplan-Meier method. RESULTS: 125 women with vulvar cancer were seen between 2010 and 2021, but only 42% were seen at PCS, mostly polysymptomatic, after several visits to the emergency room. 89% of the patients seen at PCS died at home. CONCLUSIONS: Vulvar cancer is a rare type of cancer, while squamous cell carcinoma is the most frequent type. At the time of referral, almost half of the patients had severe pain, bleeding, malodor, infection and urinary incontinence. Most of these patients lived in poverty, were poorly educated and had multiple surgeries. PC may play an important role in the care of patients with advanced vulvar cancer, relieving the physical and psychological symptoms, avoiding unnecessary hospitalisation and favouring death at home without pain and other symptoms.

Hacia la objetividad en la valoración ética: legibilidad como parte de la comprensión de los formatos de consentimiento informado / Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension

Resumen Antecedentes: Se describe la experiencia sobre la legibilidad de los formatos de consentimiento informado (FCI) del Comité de Ética en Investigación del Instituto Nacional de Cancerología de México. Objetivo: Evaluar la legibilidad de una muestra seleccionada aleatoriamente de FCI sometidos para revisión entre el 1 de marzo de 2022 y el 31 de marzo de 2023. Se determinó el número de páginas, el tiempo que el lector invierte para leer el texto y el grado de escolaridad necesario para comprenderlo. Resultados: Más de la mitad de FCI de investigaciones internas mostraron ser algo o muy difíciles de leer, la escolaridad necesaria para comprenderlos fue hasta de 9.9 años y el tiempo de lectura fue corto. Los textos de los FCI de investigaciones internacionales multicéntricas estuvieron dirigidos a un nivel escolar promedio de 5.5 años y tuvieron una legibilidad normal. La mayor parte de los ensayos externos requiere un tiempo de lectura superior a los 60 minutos por FCI. Conclusión: Es necesario disponer de herramientas que den objetividad a la evaluación de los FCI en investigación por parte de los comités de ética y sean indicadores de su comprensión, tales como la legibilidad de los documentos.

Abstract Background: The experience on informed consent form (ICF) readability at the Research Ethics Committee of the National Institute of Cancerology of Mexico (INCan) is described. Objective: To evaluate the readability of a randomly-selected sample of ICFs submitted for review between March 1, 2022 and March 31, 2023. The number of pages, the time the reader takes to read the text and the level of education necessary to understand it were determined. Results: More than half the ICFs from internal investigations were shown to be somewhat or very difficult to read; the level of education required to understand them was up to 9.9 years, and the reading time was short. The ICF texts from international multicenter investigations were aimed at an average education level of 5.5 years and had normal readability. Most ICFs from external trials require a reading time of more than 60 minutes per ICF. Conclusion: It is necessary to have tools that provide objectivity to the evaluation of ICFs under investigation by ethics committees, which should be indicators of their comprehension, such as readability of the documents.

Who judges medical practice?

Lawsuits due to patient perception of inappropriate medical actions are a growing reality in medical practice, which entails widespread concern in the medical community. Lawsuits often entail additional circumstances beyond the primary concern of preventing or sanctioning acts of medical negligence. CETREMI proposes various recommendations aimed at legal and medical professionals to improve this circumstance and avoid harming the doctor-patient relationship.

Las demandas judiciales por la percepción del paciente de una actuación médica inadecuada son una realidad creciente en la práctica médica, la cual entraña una preocupación extendida en el gremio médico. Las demandas judiciales frecuentemente conllevan circunstancias adicionales a la primaria preocupación de prevenir o sancionar actos de negligencia médica. CETREMI emite algunas recomendaciones a los profesionales jurídicos y médicos para mejorar esta situación y evitar daños en la relación médico-paciente.

¿Quién juzga la actuación médica? / Who judges medical practice?

Resumen Las demandas judiciales por la percepción del paciente de una actuación médica inadecuada son una realidad creciente en la práctica médica, la cual entraña una preocupación extendida en el gremio médico. Las demandas judiciales frecuentemente conllevan circunstancias adicionales a la primaria preocupación de prevenir o sancionar actos de negligencia médica. CETREMI emite algunas recomendaciones a los profesionales jurídicos y médicos para mejorar esta situación y evitar daños en la relación médico-paciente.

Abstract Lawsuits due to patient perception of inappropriate medical actions are a growing reality in medical practice, which entails widespread concern in the medical community. Lawsuits often entail additional circumstances beyond the primary concern of preventing or sanctioning acts of medical negligence. CETREMI proposes various recommendations aimed at legal and medical professionals to improve this circumstance and avoid harming the doctor-patient relationship.

New interaction modalities between the pharmaceutical industry and physicians.

Due to sanitary restrictions secondary to the COVID-19 pandemic, various interactions between the pharmaceutical industry and physicians have changed. One of them has been the method for promoting medicinal products through academic meetings around diseases of financial interest. A recent modality has been unilateral promotion by the pharmaceutical industry through academic events with the invitation of so-called "experts" for the promotion of a specific drug. These meetings are often biased not towards optimal care of a disease, but rather towards commercial promotion of a specific drug, which may or may not be the best option, without considering associated therapeutic alternatives. The Committee of Ethics and Transparency in the Physician-Industry Relationship, of the National Academy of Medicine, analyzes this new circumstance and proposes some considerations to the medical community.

Debido a las restricciones sanitarias secundarias a la pandemia de COVID-19, diversas interacciones entre la industria farmacéutica y los médicos cambiaron. Una de ellas ha sido el método promocional de medicamentos a través de reuniones académicas en torno a padecimientos de interés financiero. Una modalidad reciente ha sido la promoción unilateral de un fármaco determinado por parte de la industria farmacéutica por medio de eventos académicos con la invitación de aparentes "expertos". Estas reuniones frecuentemente están sesgadas no hacia la atención óptima de un padecimiento, sino a la promoción comercial de un medicamento específico que pudiera o no ser la mejor opción o sin la consideración de alternativas terapéuticas asociadas. El Comité de Ética y Transparencia en la Relación Médico-Industria, de la Academia Nacional de Medicina de México, analiza esta nueva circunstancia y propone algunas consideraciones a la comunidad médica.

Nuevas modalidades de interacción entre la industria farmacéutica y los médicos / New interaction modalities between the pharmaceutical industry and physicians

Resumen Debido a las restricciones sanitarias secundarias a la pandemia de COVID-19, diversas interacciones entre la industria farmacéutica y los médicos cambiaron. Una de ellas ha sido el método promocional de medicamentos a través de reuniones académicas en torno a padecimientos de interés financiero. Una modalidad reciente ha sido la promoción unilateral de un fármaco determinado por parte de la industria farmacéutica por medio de eventos académicos con la invitación de aparentes "expertos". Estas reuniones frecuentemente están sesgadas no hacia la atención óptima de un padecimiento, sino a la promoción comercial de un medicamento específico que pudiera o no ser la mejor opción o sin la consideración de alternativas terapéuticas asociadas. El Comité de Ética y Transparencia en la Relación Médico-Industria, de la Academia Nacional de Medicina de México, analiza esta nueva circunstancia y propone algunas consideraciones a la comunidad médica.

Abstract Due to sanitary restrictions secondary to the COVID-19 pandemic, various interactions between the pharmaceutical industry and physicians have changed. One of them has been the method for promoting medicinal products through academic meetings around diseases of financial interest. A recent modality has been unilateral promotion by the pharmaceutical industry through academic events with the invitation of so-called "experts" for the promotion of a specific drug; these meetings are often biased not towards optimal care of a disease, but rather towards commercial promotion of a specific drug, which may or may not be the best option, without considering associated therapeutic alternatives. The Committee of Ethics and Transparency in the Physician-Industry Relationship, of the National Academy of Medicine, analyzes this new circumstance and proposes some considerations to the medical community.

Lecciones aprendidas y retos en la integración de cuidados paliativos en oncología. Experiencia en el Instituto Nacional de Cancerología.

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