cee1ae049450018f30e8207a43e57325 healthcare_a2022v10n6p1036.pdf 0e3d81465b3ca1a7d6c797637da29e6ac461ea11 healthcare_a2022v10n6p1036.pdf d06dfee9fdb363919b7199ae15d723e473452307e1fda67cf22dc2fc23a4b28d healthcare_a2022v10n6p1036.pdf Title: Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial Subject: The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. Methods: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. Results: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. Conclusions: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects. Keywords: aged; informed consent form; nurses; randomized controlled trial Author: Maria López-Parra, Francesc Zamora-Carmona, Mònica Sianes-Gallén, Esmeralda López-González, Dolors Gil-Rey, Helena Costa-Ventura, Miriam Borrás-Sánchez, Gemma Rayo-Posadas, Marta Arizu-Puigvert and Roser Vives-Vilagut Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Thu Jun 2 12:22:32 2022 CEST ModDate: Thu Jun 2 12:30:49 2022 CEST Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 9 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 431008 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- OHKNFJ+VnURWPalladioL Type 1 Custom yes yes no 10 0 BDDTLD+URWPalladioL-Bold Type 1 Custom yes yes no 15 0 LNZKUN+URWPalladioL-Roma Type 1 Custom yes yes no 20 0 STGTLQ+URWPalladioL-Ital Type 1 Custom yes yes no 24 0 JODPWK+VnURWPalladioL-Bold Type 1 Custom yes yes no 28 0 XAOEUN+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 46 0 URYLRZ+URWPalladioL-BoldItal Type 1 Custom yes yes no 69 0 LGTZLE+CMSY10 Type 1 Builtin yes yes no 73 0 JFBEHA+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 84 0 JFBEIC+PalatinoLinotype TrueType WinAnsi yes yes no 87 0 JFBEIE+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 90 0 JFBGIK+PalatinoLinotype,BoldItalic TrueType WinAnsi yes yes no 93 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2023-05-30 02:32:17 CEST RepresentationInformation: healthcare_a2022v10n6p1036.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2022-06-21 12:07:27 CEST Size: 431008 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 201 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@44c8afef Item: Title: Materials and Methods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7b69c6ba Item: Title: Results Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@46daef40 Item: Title: Discussion Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@12f41634 Item: Title: Conclusions Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@13c27452 Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@262b2c86 Info: Title: Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial Author: Maria López-Parra, Francesc Zamora-Carmona, Mònica Sianes-Gallén, Esmeralda López-González, Dolors Gil-Rey, Helena Costa-Ventura, Miriam Borrás-Sánchez, Gemma Rayo-Posadas, Marta Arizu-Puigvert and Roser Vives-Vilagut Subject: The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. Methods: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. Results: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. Conclusions: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects. 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