Evaluación y mejora de la calidad de los documentos de consentimiento informado en nueve hospitales del servicio murciano de salud

Calle-Urra, José Eduardo; Parra-Hidalgo, Pedro; Saturno-Hernández, Pedro Jesús; Fonseca-Miranda, Yadira; Martínez-Martínez, Mª Jesús

doi:10.4321/s1135-57272015000300008

Cited by 4 publications

(1 citation statement)

References 10 publications

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“…The education level of Chinese resident was relatively low, with 37.46% at or below the primary school level and 36.18% at the secondary school level [ 23 ], leading to the reading difficulties for the participants. Similarly, other studies found that ICFs from the United States, New Zealand, France, Spain, and Croatia failed to offer subjects complete information using clear and direct language [ 11 , 16 – 18 , 28 , 29 ]. 97% of Canadian ICFs used appropriate section headings to label the separate sections of content, and such headings were helpful for reading comprehension, and the results are just consistent with ours [ 16 ].…”

Section: Discussionmentioning

confidence: 88%

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

et al. 2016

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PurposeTo explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs.MethodsThe length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared.ResultsAmong the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02–4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05).ConclusionThe ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China.

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Section: Discussionmentioning

confidence: 88%

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

et al. 2016

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Percepción de los usuarios frente a la calidad de atención en salud del servicio de consulta externa según el modelo SERVQUAL

Boada-Niño¹,

Barbosa-López

Cobo-Mejía

2019

Revista Investig. Salud Univ. Boyacá

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Introducción. La atención en salud se mide en términos de calidad, efectividad, eficiencia y eficacia, a través de la satisfacción por parte de los usuarios. Objetivo. Determinar la percepción de la calidad de atención en salud de consulta externa en una Institución Prestadora de Servicios de Salud-IPS, en el primer semestre del año 2018. Método. Estudio de tipo descriptivo, con diseño transversal, donde se aplica el modelo SERVQUAL que evalúa cinco dimensiones: elementos tangibles, fiabilidad, capacidad de respuesta, seguridad y empatía; con una muestra de 282 usuarios. Resultados. Se obtuvo un promedio de 3,4711 en expectativas, 3,5140 para percepciones y 3,50 general, que equivale a un 70%, lo que significa satisfecho; a la vez, no se da asociación entre la percepción y las características sociodemográficas. Conclusiones. Es importante que generar estrategias organizacionales que permitan la mejora continua en cuanto a la estructura física de las instalaciones, insumos, equipos, personal, señalización, limpieza, comodidad, entre otras, al momento de prestar los servicios de salud.

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Formal Quality and Compliance of Informed Consent Forms in Critical Care and Surgical Areas in Spain: An Observational Study

et al. 2022

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(1) Background: The informed consent form must contain all the relevant information about the procedure to be performed to guarantee the patient’s freedom to choose. (2) Objective: To analyze the formal quality of, and compliance with informed consent forms in critical care and surgical areas in a county hospital in Spain. (3) Methods: The formal quality of informed consent forms in critical care and surgical areas from the hospital were analyzed, following the established formal quality criteria for informed consent forms. The compliance with specific criteria for each of the operated patients during the period of study was also evaluated. (4) Results: The formal quality of 224 informed consent forms was analyzed from 8 disciplines observing a median of non-compliances of 4 with a minimum of 1 and a maximum of 5, with the most breaches being in verifying the delivery of a copy to the patient and showing contraindications. The compliance of 376 documents from 188 operated patients were assessed, highlighting that the non-complied items were: the personalized risks and complete identification of the patient and the physician. A significant association was found between disciplines analyzed and the identification of the physician and personalized risks, with anesthesia and critical care showing the best compliance. (4) Conclusions: The informed consent forms in critical care and surgical areas were shown to have a deficient formal quality and an inadequate compliance. These deficiencies should be corrected to improve the information received by the patients and to guarantee their freedom to choose. As nurses have a responsibility to ensure that patients are adequately informed about both nursing interventions and care, as well as the surgical treatments they receive, consideration should be given to the possibility of nursing professionals taking the lead in obtaining informed consent.

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Evaluación y mejora de la calidad de los documentos de consentimiento informado en nueve hospitales del servicio murciano de salud

Abstract: The improvement achieved in the quality of informed consent documents is related to the effectiveness of corrective measures implemented.

Cited by 4 publications

References 10 publications

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

Percepción de los usuarios frente a la calidad de atención en salud del servicio de consulta externa según el modelo SERVQUAL

Formal Quality and Compliance of Informed Consent Forms in Critical Care and Surgical Areas in Spain: An Observational Study

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