Effectiveness and safety of caplacizumab in acquired thrombotic thrombocytopenic purpura: health technology assessment and classification according to the methodology established in Colombia.

OBJECTIVES: Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare hematological disease whose clinical management includes caplacizumab along with plasma exchange and immunosuppression, according to international guidelines. Caplacizumab has been available in Colombia since 2022. This study seeks to determine the therapeutic classification of caplacizumab according to the methodology of the Instituto de Evaluación Tecnológica en Salud. METHODS: The classification was carried out through a deliberative process following the modified Delphi technique, with a panel of experts, made up of four hemato-oncologists, a pharmaceutical chemist, and a patient. The results of effectiveness and safety obtained through a systematic review, therapeutic thresholds (clinical significance), and degree of acceptability (willingness to use the technology) were used for the classification. RESULTS: Fourteen effectiveness and safety outcomes were submitted for the classification process. Caplacizumab showed clinical significance for some effectiveness outcomes, was not considered inferior in terms of safety, and displayed acceptability of use. Through consensus, the panel determined that caplacizumab plus the standard regimen is superior to the standard regimen in terms of treatment response and composite outcome, and no different for the other effectiveness and safety outcomes. Likewise, in overall terms, the panel determined that caplacizumab together with the standard regimen is superior to the standard regimen. CONCLUSION: Treatment with caplacizumab together with the standard regimen was considered superior to the standard regimen for the treatment of patients with aTTP, as it showed clinically significant benefits in critical outcomes for decision making, and a safety profile no different to its comparator.

[Identification of quality indicators for physiotherapy: a systematic review.] / Identificación de indicadores de calidad para fisioterapia: una revisión sistemática.

BACKGROUND: Despite the emerging role that indicators have for the evaluation of quality in physiotherapy, these have been developed mainly for other areas of health and only some are relevant and applicable for physiotherapy. The objective of this review was to identify the quality indicators (QI) described or developed in the evidence that can be used to assess the quality of the provision of physiotherapy services. METHODS: A systematic review was carried out, in the databases Embase, Web of science SciELO, LILACS and OPEN GREY, until March 2021, in search of studies published in Spanish, English and Portuguese that described the development of QI specifically for the practice of physiotherapy. The methodological quality of the indicators was evaluated using the AIRE instrument. The indicators were classified following the Donabedian model. RESULTS: 8 studies were included that described 8 sets of QIs, with a total of 199 indicators. Six of the sets were published in the Netherlands. 62.5% of the total indicators were process, mostly related to the care of patients with musculoskeletal pathologies. Of the total of studies, 37.5% achieved high quality in three domains of the AIRE instrument. CONCLUSIONS: The QI described in the evidence were designed for specific national contexts based on their own health system, have a methodological quality and are focused on evaluating the care processes of physiotherapy services mainly in patients with musculoskeletal diseases.

OBJETIVO: A pesar del papel emergente que tienen los indicadores para la evaluación de la calidad en fisioterapia, estos han sido desarrollados principalmente para otras áreas de la salud y sólo algunos son relevantes y aplicables para la fisioterapia. El objetivo de esta revisión fue identificar los indicadores de calidad (IC) descritos o desarrollados en la evidencia que puedan ser utilizados para evaluar la calidad en la prestación de servicios de fisioterapia. METODOS: Se realizó una revisión sistemática, en las bases de datos Embase, Web of science SciELO, LILACS y OPEN GREY, hasta Marzo del 2021, en busca de estudios publicados en español, inglés y portugués que describieron el desarrollo de IC específicamente para la práctica de fisioterapia. Se evaluó la calidad metodológica de los indicadores por medio del instrumento AIRE. Se clasificaron los indicadores siguiendo el modelo de Donabedian. RESULTADOS: Se incluyeron 8 estudios que describieron 8 conjuntos de IC, con un total de 199 indicadores. Seis de los conjuntos fueron publicados en países bajos. El 62,5% del total de los indicadores eran de proceso, relacionados en su gran mayoría con la atención de pacientes con patologías musculoesqueléticas. Del total de estudios, el 37,5% alcanzó una alta calidad en tres dominios del instrumento AIRE. CONCLUSIONES: Los IC descritos en la evidencia fueron diseñados para contextos nacionales específicos basados en su propio sistema de salud, tienen una baja calidad metodológica y están concentrados en evaluar los procesos de atención de los servicios de fisioterapia principalmente en pacientes con enfermedades musculoesqueléticas.

Identificación de indicadores de calidad para fisioterapia: una revisión sistemática / Identification of quality indicators for physiotherapy: a systematic review

Fundamentos: A pesar del papel emergente que tienen los indicadores para la evaluación de la calidad en fisioterapia, estos han sido desarrollados principalmente para otras áreas de la salud y sólo algunos son relevantes y aplicables para la fisioterapia. El objetivo de esta revisión fue identificar los indicadores de calidad (IC) descritos o desarrollados en la evidencia que puedan ser utilizados para evaluar la calidad en la prestación de servicios de fisioterapia. Métodos: Se realizó una revisión sistemática, en las bases de datos Embase, Web of science SciELO, LILACS y OPEN GREY, hasta Marzo del 2021, en busca de estudios publicados en español, inglés y portugués que describieron el desarrollo de IC específicamente para la práctica de fisioterapia. Se evaluó la calidad metodológica de los indicadores por medio del instrumento AIRE. Se clasificaron los indicadores siguiendo el modelo de Donabedian. Resultados: Se incluyeron 8 estudios que describieron 8 conjuntos de IC, con un total de 199 indicadores. Seis de los conjuntos fueron publicados en países bajos. El 62,5% del total de los indicadores eran de proceso, relacionados en su gran mayoría con la atención de pacientes con patologías musculoesqueléticas. Del total de estudios, el 37,5% alcanzó una alta calidad en tres dominios del instrumento AIRE. Conclusiones: Los IC descritos en la evidencia fueron diseñados para contextos nacionales específicos basados en su propio sistema de salud, tienen una baja calidad metodológica y están concentrados en evaluar los procesos de atención de los servicios de fisioterapia principalmente en pacientes con enfermedades musculoesqueléticas.(AU)

Background: Despite the emerging role that indicators have for the evaluation of quality in physiotherapy, these have been developed mainly for other areas of health and only some are relevant and applicable for physiotherapy. The objective of this review was to identifythe quality indicators (QI) described or developed in the evidence that can be used to assess the quality of the provision of physiotherapy services. Methods: A systematic review was carried out, in the databases Embase, Web of science SciELO, LILACS and OPEN GREY, until March 2021, in search of studies published in Spanish, English and Portuguese that describedthe development of QI specifically for the practice of physiotherapy. The methodological quality of the indicatorswas evaluated using the AIRE instrument. The indicators were classified following the Donabedian model. Results: 8 studies were included that described 8 sets of QIs, with a total of 199 indicators. Six of the sets were published in the Netherlands. 62.5% of the total indicators were process, mostly related to the care of patientswith musculoskeletal pathologies. Of the total of studies, 37.5% achieved high quality in three domains of the AIRE instrument. Conclusions: The QI described in the evidence were designed for specific national contexts based on their own health system, have a methodological quality and are focused on evaluating the care processes of physiotherapyservices mainly in patients with musculoskeletal diseases.(AU)