{"id":15130,"date":"2021-07-02T18:43:59","date_gmt":"2021-07-02T22:43:59","guid":{"rendered":"https:\/\/mdic-spi.org\/?p=15130"},"modified":"2022-02-11T12:29:13","modified_gmt":"2022-02-11T17:29:13","slug":"patient-centered-identification-of-meaningful-regulatory-endpoints-for-medical-devices-to-treat-parkinsons-disease-pcor-project-aim-1-paper","status":"publish","type":"post","link":"https:\/\/mdic-spi.org\/patient-centered-identification-of-meaningful-regulatory-endpoints-for-medical-devices-to-treat-parkinsons-disease-pcor-project-aim-1-paper\/","title":{"rendered":"Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson’s Disease (PCOR Project Aim 1 Paper)"},"content":{"rendered":"

[et_pb_section fb_built=”1″ _builder_version=”4.9.3″ _module_preset=”default” background_color=”#005ca8″ min_height=”96px” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” global_module=”13944″ saved_tabs=”all” global_colors_info=”{}”][et_pb_row _builder_version=”4.9.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.9.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_search placeholder=”BEGIN YOUR SEARCH HERE…” button_color=”#e2a632″ placeholder_color=”#424242″ _builder_version=”4.14.2″ _module_preset=”default” form_field_background_color=”#FFFFFF” form_field_text_color=”#000000″ button_text_color=”#ffffff” border_width_all=”0px” global_colors_info=”{}”][\/et_pb_search][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”4.9.0″ _module_preset=”default” background_enable_color=”off” global_colors_info=”{}”][et_pb_fullwidth_post_title author=”off” comments=”off” featured_image=”off” text_background=”on” text_bg_color=”#FFFFFF” _builder_version=”4.9.10″ _module_preset=”default” use_background_color_gradient=”on” background_color_gradient_start=”#005ca8″ background_color_gradient_end=”rgba(0,92,168,0.31)” background_color_gradient_overlays_image=”on” background_image=”https:\/\/mdic-spi.org\/wp-content\/uploads\/2021\/02\/circuitry-header-background-scaled.jpg” global_colors_info=”{}”][\/et_pb_fullwidth_post_title][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Patient Introduction for Article” module_class=”article-patient-intro” _builder_version=”4.9.0″ _module_preset=”default” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” global_colors_info=”{}”][et_pb_row admin_label=”Patient Perspective – Row Toggle” _builder_version=”4.9.0″ _module_preset=”default” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.7.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_toggle title=”Patient Introduction” open=”on” open_toggle_text_color=”#FFFFFF” icon_color=”#FFFFFF” use_icon_font_size=”on” icon_font_size=”23px” open_icon_color=”#FFFFFF” open_use_icon_font_size=”on” open_icon_font_size=”23px” _builder_version=”4.14.2″ _module_preset=”default” title_text_color=”#FFFFFF” title_level=”h3″ body_text_color=”#FFFFFF” background_color=”#85bfd1″ text_orientation=”left” hover_enabled=”0″ border_width_all=”0px” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

A growing body of literature has developed identifying outcomes that matter to patients. The study that these published articles (Aims 1, 2 & 3 of MDIC\u2019s PCOR project<\/a>) are based on demonstrates an approach to identifying outcomes of medical devices for Parkinson\u2019s disease that are meaningful to patients and regulators. This approach is of interest to patients who seek to provide input to the design of medical device clinical trials to ensure that what matters to patients is incorporated into study endpoints. Although Parkinson\u2019s disease was the disease focused on for this study, the approach can be used to study patient perspectives about other disease or treatment areas. This paper summarizes Aim 1 of the project, describing the process that was used to identify nine specific aspects of potential treatments for Parkinson\u2019s disease that should be measured in a clinical trial for a medical device for these patients.<\/p>\n

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Summary<\/h2>\n

Parkinson\u2019s disease (PD) is a neurodegenerative condition, causing motor, cognitive, psychological, somatic, and autonomic symptoms. This article, published in the journal MDM Policy & Practice describes Aim 1 of the MDIC Parkinson\u2019s disease PCOR project<\/a>, in which nine meaningful patient-centric attributes were identified for use in clinical trial design and quantitative patient preference studies. These nine attributes were benefits and risks related to therapeutics for Parkinson\u2019s disease as well as time until a medical device is available for patient use and number of oral medicines taken each day to treat Parkinson\u2019s disease and their side effects. This prospective approach identified meaningful and relevant benefits, risks, and other considerations that may be used for clinical trial design and quantitative patient preference studies.<\/p>\n

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A growing body of literature has developed identifying outcomes that matter to patients. The study that these published articles (Aims 1, 2 & 3 of MDIC\u2019s PCOR project) are based on demonstrates an approach to identifying outcomes of medical devices for Parkinson\u2019s disease that are meaningful to patients and regulators. This approach is of interest […]<\/p>\n","protected":false},"author":4,"featured_media":15141,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[7,4,5,16,6,8],"tags":[41,62,56],"yoast_head":"\nPatient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson's Disease (PCOR Project Aim 1 Paper) - MDIC<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdic-spi.org\/patient-centered-identification-of-meaningful-regulatory-endpoints-for-medical-devices-to-treat-parkinsons-disease-pcor-project-aim-1-paper\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson's Disease (PCOR Project Aim 1 Paper) - MDIC\" \/>\n<meta property=\"og:description\" content=\"A growing body of literature has developed identifying outcomes that matter to patients. 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