a160da1cbf57848ad5f090add028ff6e 283220.pdf 2da0895516e26b2d668444c731aad5b06e16601c 283220.pdf 48b0509a6402ccef58ae14665952303a1103f0176c48522d026e9ed54a8d52ce 283220.pdf Title: PROSHADE Protocol: Designing and Evaluating a Decision Aid for Promoting Shared Decision Making in Opportunistic Screening for Prostate Cancer: A Mix-Method Study Subject: Background: Opportunistic prostate-specific antigen (PSA) screening may reduce prostate cancer mortality risk but is associated with false positive results, biopsy complications and overdiagnosis. Although different organisations have emphasised the importance of shared decision making (SDM) to assist men in deciding whether to undergo prostate cancer screening, recent evaluations show that the available decision aids fail to facilitate SDM, mainly because they do not consider the patients’ perspective in their design. We aim to systematically develop and test a patient decision aid to promote SDM in prostate cancer screening, following the Knowledge to Action framework. Methods: (1) Feasibility study: a quantitative survey evaluating the population and clinician (urologists and general practitioners) knowledge of the benefits and risks derived from PSA determination and the awareness of the available recommendations. Focus groups to explore the challenges patients and clinicians face when discussing prostate cancer screening, the relevance of a decision aid and how best to integrate it into practice. (2) Patient decision aid development: Based on this data, an evidence-based multicomponent SDM patient decision aid will be developed. (3) User-testing: an assessment of the prototype of the initial patient decision aid through a user-testing design based on mix-methods (questionnaire and semi-structured review). The decision aid will be refined through several iterative cycles of feedback and redesign. (4) Validation: an evaluation of the patient decision aid through a cluster-randomised controlled trial. Discussion: The designed patient decision aid will provide balanced information on screening benefits and risks and should help patients to consider their personal preferences and to take a more active role in decision making. Conclusions: The well-designed patient decision aid (PDA) will provide balanced information on screening benefits and risks and help patients consider their personal preferences. Keywords: prostate cancer screening; prostate specific antigen (PSA); shared decision making (SDM) Author: Blanca Lumbreras, Lucy Anne Parker, Pablo Alonso-Coello, Javier Mira-Bernabeu, Luis Gómez-Pérez, Juan Pablo Caballero-Romeu, Salvador Pertusa-Martínez, Ana Cebrián-Cuenca, Irene Moral-Peláez, Maite López-Garrigós, Carlos Canelo-Aybar, Elena Ronda, Mercedes Guilabert, Antonio Prieto-González and Ildefonso Hernández-Aguado Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Fri Jul 22 11:28:27 2022 CEST ModDate: Fri Jul 22 11:31:26 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: 500639 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- JYPLJJ+VnURWPalladioL-Bold Type 1 Custom yes yes no 10 0 AZBFJT+VnURWPalladioL Type 1 Custom yes yes no 15 0 YHANRF+URWPalladioL-Bold Type 1 Custom yes yes no 19 0 ESYLKF+URWPalladioL-Roma Type 1 Custom yes yes no 24 0 AHXSCQ+URWPalladioL-Ital Type 1 Custom yes yes no 28 0 LWQXII+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 46 0 IRWHZX+TimesNewRomanPSMT Type 1C WinAnsi yes yes no 49 0 NLEELM+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 77 0 NLEELO+PalatinoLinotype TrueType WinAnsi yes yes no 80 0 NLEENA+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 83 0 NLEGAJ+Calibri CID TrueType Identity-H yes yes yes 86 0 NLEGCJ+Calibri,Bold CID TrueType Identity-H yes yes yes 92 0 JLZORU+EURM10 Type 1 Builtin yes yes no 104 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2023-11-07 02:39:06 CET RepresentationInformation: 283220.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2023-11-06 10:29:41 CET Size: 500639 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 232 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Background Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@4d3167f4 Item: Title: Materials and Methods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@ed9d034 Children: Item: Title: Study Overview Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@6121c9d6 Children: Item: Title: Phase 1: Feasibility Test Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@87f383f Item: Title: Phase 2: Patient Decision Aid Development Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@4eb7f003 Item: Title: Phase 3: User-Testing Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@eafc191 Item: Title: Phase 4: Validation of the PDA Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@612fc6eb Item: Title: Data Collection Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1060b431 Item: Title: Statistical Analysis Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@612679d6 Item: Title: Study Status Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@11758f2a Item: Title: Ethics and Dissemination Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@e720b71 Item: Title: Discussion Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1b26f7b2 Item: Title: Challenges and Limitations Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@491cc5c9 Item: Title: Conclusions Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@74ad1f1f Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@6a1aab78 Info: Title: PROSHADE Protocol: Designing and Evaluating a Decision Aid for Promoting Shared Decision Making in Opportunistic Screening for Prostate Cancer: A Mix-Method Study Author: Blanca Lumbreras, Lucy Anne Parker, Pablo Alonso-Coello, Javier Mira-Bernabeu, Luis Gómez-Pérez, Juan Pablo Caballero-Romeu, Salvador Pertusa-Martínez, Ana Cebrián-Cuenca, Irene Moral-Peláez, Maite López-Garrigós, Carlos Canelo-Aybar, Elena Ronda, Mercedes Guilabert, Antonio Prieto-González and Ildefonso Hernández-Aguado Subject: Background: Opportunistic prostate-specific antigen (PSA) screening may reduce prostate cancer mortality risk but is associated with false positive results, biopsy complications and overdiagnosis. Although different organisations have emphasised the importance of shared decision making (SDM) to assist men in deciding whether to undergo prostate cancer screening, recent evaluations show that the available decision aids fail to facilitate SDM, mainly because they do not consider the patients’ perspective in their design. We aim to systematically develop and test a patient decision aid to promote SDM in prostate cancer screening, following the Knowledge to Action framework. Methods: (1) Feasibility study: a quantitative survey evaluating the population and clinician (urologists and general practitioners) knowledge of the benefits and risks derived from PSA determination and the awareness of the available recommendations. Focus groups to explore the challenges patients and clinicians face when discussing prostate cancer screening, the relevance of a decision aid and how best to integrate it into practice. (2) Patient decision aid development: Based on this data, an evidence-based multicomponent SDM patient decision aid will be developed. (3) User-testing: an assessment of the prototype of the initial patient decision aid through a user-testing design based on mix-methods (questionnaire and semi-structured review). The decision aid will be refined through several iterative cycles of feedback and redesign. (4) Validation: an evaluation of the patient decision aid through a cluster-randomised controlled trial. Discussion: The designed patient decision aid will provide balanced information on screening benefits and risks and should help patients to consider their personal preferences and to take a more active role in decision making. Conclusions: The well-designed patient decision aid (PDA) will provide balanced information on screening benefits and risks and help patients consider their personal preferences. 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