RESUMO
Introduction: Colombia has modified the nuclear medicine norms that impact the administration of radioactive iodine therapy in the treatment of thyroid cancer. Objective: To identify the areas of agreement regarding the issue, as well as the current and emergent requirements associated with the normative for the operation of nuclear medicine services that have an impact on the care of patients with thyroid cancer in Colombia. Materials and methods: We conducted a two-round Delphi study for each expert, clinical, and regulatory group. The first round explored views on the implications of the regulations that apply to nuclear medicine. The second round rated the statements from the first round by their relevance. Results: The issues regarding nuclear medicine services were related to the normative clarity and the lack of synergy and coherence among inspection, surveillance, and control bodies. The demands on the waste management system require a high economic investment that can influence the service offer and have an impact on the integral control of thyroid cancer. Unification of the auditors' criteria, delimitation of the acting agent functions, technical assistance to the services to comply with the normative, and the oversight of the inspection, surveillance, and control bodies by the regulatory entities are among the current and future needs. Conclusions: Our findings suggest that nuclear medicine services are going through a time of multiple institutional, regulatory, and economic challenges that put at risk the development and maintenance of nuclear medicine in cancer care.
Introducción. La modificación de las normas sobre medicina nuclear en Colombia ha afectado la administración de la terapia de yodo radioactivo en el tratamiento del cáncer de tiroides. Objetivos. Determinar las áreas de acuerdo en torno al problema, los requisitos actuales y los nuevos exigidos en la normativa para el funcionamiento de los servicios de medicina nuclear. Materiales y métodos. Se hizo un estudio Delphi de dos rondas con cada grupo de expertos, 'clínicos' y 'de entidades reguladoras'. En la primera ronda se exploraron los puntos de vista sobre las implicaciones de la normativa en medicina nuclear y, en la segunda, se calificaron las declaraciones de la primera según su relevancia. Resultados. La problemática de los servicios de medicina nuclear está relacionada con la claridad normativa, y la falta de sinergia y coherencia entre los organismos de inspección, vigilancia y control. Las exigencias del sistema de gestión de desechos requieren una alta inversión económica que puede influir en la oferta del servicio y repercutir en el control integral del cáncer de tiroides. Entre las necesidades presentes y futuras, se encuentran la unificación de criterios entre los auditores, la delimitación de funciones de los actuantes, la asistencia técnica para cumplir con la normativa, y la veeduría a los organismos de inspección, vigilancia y control por parte de los entes reguladores. Conclusión. Los hallazgos del estudio sugieren que los servicios de medicina nuclear atraviesan un momento de múltiples desafíos institucionales, normativos y económicos, que ponen en riesgo el desarrollo y mantenimiento de la medicina nuclear en la atención oncológica.
Assuntos
Medicina Nuclear , Neoplasias da Glândula Tireoide , Colômbia , Técnica Delphi , Humanos , Radioisótopos do Iodo , Percepção , Neoplasias da Glândula Tireoide/terapiaRESUMO
Resumen | Introducción. La modificación de las normas sobre medicina nuclear en Colombia ha afectado la administración de la terapia de yodo radioactivo en el tratamiento del cáncer de tiroides. Objetivos. Determinar las áreas de acuerdo en torno al problema, los requisitos actuales y los nuevos exigidos en la normativa para el funcionamiento de los servicios de medicina nuclear. Materiales y métodos. Se hizo un estudio Delphi de dos rondas con cada grupo de expertos, 'clínicos' y 'de entidades reguladoras'. En la primera ronda se exploraron los puntos de vista sobre las implicaciones de la normativa en medicina nuclear y, en la segunda, se calificaron las declaraciones de la primera según su relevancia. Resultados. La problemática de los servicios de medicina nuclear está relacionada con la claridad normativa, y la falta de sinergia y coherencia entre los organismos de inspección, vigilancia y control. Las exigencias del sistema de gestión de desechos requieren una alta inversión económica que puede influir en la oferta del servicio y repercutir en el control integral del cáncer de tiroides. Entre las necesidades presentes y futuras, se encuentran la unificación de criterios entre los auditores, la delimitación de funciones de los actuantes, la asistencia técnica para cumplir con la normativa, y la veeduría a los organismos de inspección, vigilancia y control por parte de los entes reguladores. Conclusión. Los hallazgos del estudio sugieren que los servicios de medicina nuclear atraviesan un momento de múltiples desafíos institucionales, normativos y económicos, que ponen en riesgo el desarrollo y mantenimiento de la medicina nuclear en la atención oncológica.
Abstract | Introduction: Colombia has modified the nuclear medicine norms that impact the administration of radioactive iodine therapy in the treatment of thyroid cancer. Objective: To identify the areas of agreement regarding the issue, as well as the current and emergent requirements associated with the normative for the operation of nuclear medicine services that have an impact on the care of patients with thyroid cancer in Colombia. Materials and methods: We conducted a two-round Delphi study for each expert, clinical, and regulatory group. The first round explored views on the implications of the regulations that apply to nuclear medicine. The second round rated the statements from the first round by their relevance. Results: The issues regarding nuclear medicine services were related to the normative clarity and the lack of synergy and coherence among inspection, surveillance, and control bodies. The demands on the waste management system require a high economic investment that can influence the service offer and have an impact on the integral control of thyroid cancer. Unification of the auditors' criteria, delimitation of the acting agent functions, technical assistance to the services to comply with the normative, and the oversight of the inspection, surveillance, and control bodies by the regulatory entities are among the current and future needs. Conclusions: Our findings suggest that nuclear medicine services are going through a time of multiple institutional, regulatory, and economic challenges that put at risk the development and maintenance of nuclear medicine in cancer care.
Assuntos
Neoplasias da Glândula Tireoide , Medicina Nuclear , Radioisótopos , Resíduos Radioativos , Serviços de SaúdeRESUMO
OBJECTIVE: To assess the effect of operational factors on the positivity rates of three HPV assays. METHODS: Within the cross-sectional ESTAMPA study, women aged 30-64 years were recruited at healthcare centers from Soacha, Colombia, during 2012-2015. Cervical samples were collected for cotesting with Hybrid Capture 2 (HC2; Qiagen, Gaithersburg, MD, USA), and either Aptima (Hologic, Marlborough, MA, USA) or Cobas 4800 (Roche Diagnostics, Indianapolis, IN, USA). The effect of operational factors on assay performance was assessed using adjusted positivity rates obtained from logistic regression models. RESULTS: There were 4168 women included. For samples collected in assay-specific medium, positivity rate differences were associated with the expertise of the nurse collecting the sample (P=0.014 HC2; P=0.091 Aptima) and if sample collection occurred after an initial cytology (P=0.025 HC2; P=0.033 Aptima). If PreservCyt medium (Hologic) was used, HC2 positivity differences were observed depending on the time between sample collection and processing (P=0.026) and on the laboratory technician processing the samples (P=0.003). No differences were observed for PreservCyt samples processed with Aptima or Cobas. CONCLUSION: Nurse expertise, collection of previous cytology, processing time, and laboratory technician could influence HPV assay performance. Suitable quality assurance protocols for HPV-based screening programs are required. ClinicalTrials.gov: NCT01881659.