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Estudo da Repetibilidade e Reprodutibilidade em Ensaios de Desfibrilhadores e Monitores de Sinais Vitais
| Name: | Description: | Size: | Format: | |
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| 4.22 MB | Adobe PDF |
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Advisor(s)
Abstract(s)
O desempenho adequado dos equipamentos de suporte de vida constitui um requisito
fundamental para a eficácia dos cuidados clínicos, uma vez que qualquer desvio funcional pode
comprometer a segurança do paciente e conduzir a diagnósticos ou tratamentos incorretos.
Para garantir o cumprimento deste requisito, realizam-se ensaios de acordo com métodos
rigorosamente definidos, que podem ser aprimorados de modo a refletir com maior fidelidade
o real estado de conformidade dos equipamentos.
Neste contexto, o presente estudo propõe alterações aos métodos de ensaio de
desfibrilhadores e monitores de sinais vitais ao nível da repetibilidade, com o objetivo de
estabelecer o número mínimo de medições aceitável em cada ensaio, e ao nível da
reprodutibilidade, para verificar se a variabilidade entre operadores deve ser considerada. Para
o efeito, procedeu-se a uma análise estatística a partir de medições obtidas em ensaios, a qual
englobou testes de hipóteses, boxplots, gráficos Bland-Altman, coeficientes de correlação
intraclasse e modelos lineares mistos robustos.
Os resultados revelaram que, no caso dos desfibrilhadores, são necessárias cinco medições para
o parâmetro de energia e quatro para os parâmetros de sincronismo e tempo de carga.
Relativamente aos monitores de sinais vitais, verificou-se que a saturação de oxigénio e o ritmo
cardíaco podem ser avaliados com um número inferior de medições ao praticado, sendo
suficiente realizar duas ou até uma única medição. Quanto à pressão arterial não invasiva,
constatou-se que o número atualmente definido de três medições é adequado.
Adicionalmente, concluiu-se que a influência do operador é reduzida, o que confirma que,
desde que devidamente formados, diferentes operadores podem executar os procedimentos
sem comprometer a fiabilidade dos resultados.
Contudo, o estudo apresenta algumas limitações, entre as quais se destacam o número
reduzido de medições e equipamentos analisados, bem como a necessidade de aproximação à
normalidade em alguns testes, o que, em amostras pequenas, pode comprometer a robustez
das conclusões. Face a estas limitações, recomenda-se a realização de estudos adicionais que
ampliem o tamanho e a diversidade da amostra, de modo a obter resultados mais confiáveis.
The proper performance of life support equipment is a fundamental requirement for effective clinical care, as any functional deviation can compromise patient safety and lead to incorrect diagnoses or treatments. To ensure compliance with this requirement, tests are carried out in accordance with strictly defined methods, which can be improved to more accurately reflect the actual state of compliance of the equipment. In this context, this study proposes changes to the testing methods for defibrillators and vital sign monitors in terms of repeatability, with the aim of establishing the minimum acceptable number of measurements in each test, and in terms of reproducibility, to verify whether variability between operators should be considered. To this end, a statistical analysis was performed based on measurements obtained in tests, which included hypothesis tests, boxplots, Bland-Altman plots, intraclass correlation coefficients, and robust mixed linear models. The results revealed that, in the case of defibrillators, five measurements are necessary for the energy parameter and four for the synchronisation and charging time parameters. With regard to vital sign monitors, it was found that oxygen saturation and heart rate can be assessed with fewer measurements than currently practised, with two or even a single measurement being sufficient. As for non-invasive blood pressure, it was found that the currently defined number of three measurements is adequate. Additionally, it was concluded that operator influence is reduced, confirming that, provided they are properly trained, different operators can perform the procedures without compromising the reliability of the results. However, the study has some limitations, including the small number of measurements and equipment analysed, as well as the need to approximate normality in some tests, which, in small samples, may compromise the robustness of the conclusions. Given these limitations, further studies are recommended to increase the size and diversity of the sample in order to obtain more reliable results.
The proper performance of life support equipment is a fundamental requirement for effective clinical care, as any functional deviation can compromise patient safety and lead to incorrect diagnoses or treatments. To ensure compliance with this requirement, tests are carried out in accordance with strictly defined methods, which can be improved to more accurately reflect the actual state of compliance of the equipment. In this context, this study proposes changes to the testing methods for defibrillators and vital sign monitors in terms of repeatability, with the aim of establishing the minimum acceptable number of measurements in each test, and in terms of reproducibility, to verify whether variability between operators should be considered. To this end, a statistical analysis was performed based on measurements obtained in tests, which included hypothesis tests, boxplots, Bland-Altman plots, intraclass correlation coefficients, and robust mixed linear models. The results revealed that, in the case of defibrillators, five measurements are necessary for the energy parameter and four for the synchronisation and charging time parameters. With regard to vital sign monitors, it was found that oxygen saturation and heart rate can be assessed with fewer measurements than currently practised, with two or even a single measurement being sufficient. As for non-invasive blood pressure, it was found that the currently defined number of three measurements is adequate. Additionally, it was concluded that operator influence is reduced, confirming that, provided they are properly trained, different operators can perform the procedures without compromising the reliability of the results. However, the study has some limitations, including the small number of measurements and equipment analysed, as well as the need to approximate normality in some tests, which, in small samples, may compromise the robustness of the conclusions. Given these limitations, further studies are recommended to increase the size and diversity of the sample in order to obtain more reliable results.
Description
Keywords
Test methods Repeatability Reproducibility Defibrillators Vital signs monitors Métodos de ensaio Repetibilidade Reprodutibilidade Desfibrilhadores Monitores de sinais vitais