{"markup":"\u003C?xml version=\u00221.0\u0022 encoding=\u0022UTF-8\u0022 ?\u003E\n    \u003Chtml version=\u0022HTML+RDFa+MathML 1.1\u0022\n    xmlns:content=\u0022http:\/\/purl.org\/rss\/1.0\/modules\/content\/\u0022\n    xmlns:dc=\u0022http:\/\/purl.org\/dc\/terms\/\u0022\n    xmlns:foaf=\u0022http:\/\/xmlns.com\/foaf\/0.1\/\u0022\n    xmlns:og=\u0022http:\/\/ogp.me\/ns#\u0022\n    xmlns:rdfs=\u0022http:\/\/www.w3.org\/2000\/01\/rdf-schema#\u0022\n    xmlns:sioc=\u0022http:\/\/rdfs.org\/sioc\/ns#\u0022\n    xmlns:sioct=\u0022http:\/\/rdfs.org\/sioc\/types#\u0022\n    xmlns:skos=\u0022http:\/\/www.w3.org\/2004\/02\/skos\/core#\u0022\n    xmlns:xsd=\u0022http:\/\/www.w3.org\/2001\/XMLSchema#\u0022\n    xmlns:mml=\u0022http:\/\/www.w3.org\/1998\/Math\/MathML\u0022\u003E\n  \u003Chead\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/js\/js_itu2PgFdrjV-docKmLK8Jn5oXe_05RgvQh73eOhI_mE.js\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_at_symbol.js?nzlu9d\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_article_reference_popup.js?nzlu9d\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/js\/js_I8yX6RYPZb7AtMcDUA3QKDZqVkvEn35ED11_1i7vVpc.js\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022\u003E\n\u003C!--\/\/--\u003E\u003C![CDATA[\/\/\u003E\u003C!--\n(function(i,s,o,g,r,a,m){i[\u0022GoogleAnalyticsObject\u0022]=r;i[r]=i[r]||function(){(i[r].q=i[r].q||[]).push(arguments)},i[r].l=1*new Date();a=s.createElement(o),m=s.getElementsByTagName(o)[0];a.async=1;a.src=g;m.parentNode.insertBefore(a,m)})(window,document,\u0022script\u0022,\u0022\/\/www.google-analytics.com\/analytics.js\u0022,\u0022ga\u0022);ga(\u0022create\u0022, \u0022UA-15605596-27\u0022, {\u0022cookieDomain\u0022:\u0022auto\u0022});ga(\u0022set\u0022, \u0022page\u0022, location.pathname + location.search + location.hash);ga(\u0022send\u0022, \u0022pageview\u0022);ga(\u0027create\u0027, \u0027UA-189672-26\u0027, \u0027auto\u0027, {\u0027name\u0027: \u0027hwTracker\u0027});\r\nga(\u0027hwTracker.send\u0027, \u0027pageview\u0027);\n\/\/--\u003E\u003C!]]\u003E\n\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022\u003E\n\u003C!--\/\/--\u003E\u003C![CDATA[\/\/\u003E\u003C!--\njQuery.extend(Drupal.settings, {\u0022basePath\u0022:\u0022\\\/\u0022,\u0022pathPrefix\u0022:\u0022\u0022,\u0022highwire\u0022:{\u0022markup\u0022:[{\u0022requested\u0022:\u0022full-text\u0022,\u0022variant\u0022:\u0022full-text\u0022,\u0022view\u0022:\u0022full\u0022,\u0022pisa\u0022:\u0022spmdc;14\\\/49\\\/18\u0022},{\u0022requested\u0022:\u0022long\u0022,\u0022variant\u0022:\u0022full-text\u0022,\u0022view\u0022:\u0022full\u0022,\u0022pisa\u0022:\u0022spmdc;14\\\/49\\\/18\u0022}],\u0022ac\u0022:{\u0022spmdc;14\\\/49\\\/18\u0022:{\u0022access\u0022:{\u0022reprint\u0022:true,\u0022full\u0022:true},\u0022pisa_id\u0022:\u0022spmdc;14\\\/49\\\/18\u0022,\u0022atom_uri\u0022:\u0022\u0022,\u0022jcode\u0022:\u0022spmdc\u0022}}},\u0022googleanalytics\u0022:{\u0022trackOutbound\u0022:1,\u0022trackMailto\u0022:1,\u0022trackDownload\u0022:1,\u0022trackDownloadExtensions\u0022:\u00227z|aac|arc|arj|asf|asx|avi|bin|csv|doc(x|m)?|dot(x|m)?|exe|flv|gif|gz|gzip|hqx|jar|jpe?g|js|mp(2|3|4|e?g)|mov(ie)?|msi|msp|pdf|phps|png|ppt(x|m)?|pot(x|m)?|pps(x|m)?|ppam|sld(x|m)?|thmx|qtm?|ra(m|r)?|sea|sit|tar|tgz|torrent|txt|wav|wma|wmv|wpd|xls(x|m|b)?|xlt(x|m)|xlam|xml|z|zip\u0022,\u0022trackUrlFragments\u0022:1},\u0022ajaxPageState\u0022:{\u0022js\u0022:{\u0022sites\\\/all\\\/libraries\\\/cluetip\\\/jquery.cluetip.js\u0022:1,\u0022sites\\\/all\\\/libraries\\\/cluetip\\\/lib\\\/jquery.hoverIntent.js\u0022:1,\u0022sites\\\/all\\\/libraries\\\/cluetip\\\/lib\\\/jquery.bgiframe.min.js\u0022:1,\u0022sites\\\/all\\\/modules\\\/highwire\\\/highwire\\\/plugins\\\/highwire_markup_process\\\/js\\\/highwire_at_symbol.js\u0022:1,\u0022sites\\\/all\\\/modules\\\/highwire\\\/highwire\\\/plugins\\\/highwire_markup_process\\\/js\\\/highwire_article_reference_popup.js\u0022:1,\u0022sites\\\/all\\\/modules\\\/contrib\\\/google_analytics\\\/googleanalytics.js\u0022:1,\u00220\u0022:1}}});\n\/\/--\u003E\u003C!]]\u003E\n\u003C\/script\u003E\n\u003Clink type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EIn this session, presenters focused on patient perspectives in the context of clinical trials, patient-reported outcomes, and regulatory science in the medical device industry. Presenters discussed collaborative research, centers that evaluate medical devices, patient surveys, and patient preferences in nephrology.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ETreatments\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ETreatments\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENephrology\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EIn this session, presenters focused on patient perspectives in the context of clinical trials, patient-reported outcomes, and regulatory science in the medical device industry. Presenters discussed collaborative research, centers that evaluate medical devices, patient surveys, and patient preferences in nephrology.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003ECollaborative research is conducted with patients, rather than \u201con\u201d them, and a partnership is formed that enables the shared control of the production, use, and dissemination of knowledge gained from research. Celeste Castillo Lee, University of Michigan Health System, Ann Arbor, Michigan, USA, presented the patient perspective of clinical trials. When patients are partners in research, they can help to define research questions, design surveys, formulate recommendations, and define characteristics of a patient-centered trial.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003ECarolyn Y. Neuland, PhD, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA, discussed the mission of the Center for Devices and Radiologic Health (CDRH), which is to protect and promote public health. The CDRH\u0027s vision is that all patients have access to medical devices that are safe, effective, and of high quality. When evaluating devices, the CDRH takes into account patient preferences, which include anecdotal comments submitted to the FDA, opinions expressed on social media, qualitative ad hoc surveys, and patient-reported outcome instruments. Patient preference is defined as qualitative or quantitative assessments of the relative desirability or acceptability of attributes that differ among alternative diagnostic or therapeutic strategies.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EAn example of patient preferences and benefit-risk guidance is the tolerance of risk [FDA. \u003Ca href=\u0022http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm267829.htm\u0022\u003Ehttp:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm267829.htm\u003C\/a\u003E. Accessed December 12, 2014]. Some patients have a high tolerance for risk (ie, accepting great risk to gain a small benefit), whereas others are unwilling to take on much risk for a small benefit. The FDA strives to determine what patients believe to be a meaningful benefit during the process of evaluating the efficacy of a device. To facilitate this process, the patient preference initiative was developed to request patient views of a medical device. One pilot study involves a survey to determine the feasibility of eliciting and use of patient preferences in the topic of obesity and weight loss. The results from this study helped to determine minimum clinically meaningful weight loss from the patient perspective, and it allowed researchers to determine the values that patients assign to risks vs benefits.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EIn 2012, the Medical Device Innovation Consortium (MDIC) was formed in partnership with the FDA with a mission to improve regulatory science in the medical device industry. To achieve this mission, the MDIC aims to coordinate the development of tools, methods, and resources for the management of the life cycle of a medical device. One of MDIC\u0027s projects is called the Patient-Centeredness and Benefit-Risk Assessment Project, in which there are strategies to assess the patient perspective of benefits and risks associated with a device.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003ERonald D. Perrone, MD, Tufts Medical Center, Boston, Massachusetts, USA, discussed the challenges and opportunities in patient-reported outcome (PRO) measures for kidney disease. PROs are based on data, such as survey data that are directly reported by the patient. There are multiple tools that can be used, such as generic instruments that are useful to evaluate the overall health status and disease-specific instruments that evaluate factors that are more directly affected by the disease state. For example, a survey was used to evaluate patient outcomes related to pain in autosomal dominant polycystic kidney disease (ADPKD) [Bajwa ZH et al. \u003Cem\u003EKidney Int.\u003C\/em\u003E 2004]. In the survey, about 60% of the respondents reported abdominal pain as measured by the visual analog scale.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EIn the COHORT study [Rizk D et al. \u003Cem\u003EClin J Am Soc Nephrol\u003C\/em\u003E. 2009], a survey that included a physical component summary (PCS) and a mental component summary (MCS) found no significant difference from the general population. However, patients who received pain medication 30 days before the survey had a lower PCS score. In the HALT PKD study [Miskulin DC et al. \u003Cem\u003EAm J Kidney Dis.\u003C\/em\u003E 2014], patients with ADPKD completed the Short-Form-36 health survey (SF-36) and the HALT PKD Pain Questionnaire. Fifty percent of patients reported back pain, with 20% experiencing it often, usually, or always. In addition, patients with a lower estimated glomerular filtration rate were more likely to report that pain affected their daily lives.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EIn 2013, the FDA published a report of PROs in the areas of anemia secondary to chronic kidney disease, ADPKD, and nephrotic syndrome [Perrone RD et al. \u003Cem\u003EAm J Kidney Dis.\u003C\/em\u003E 2013]. The purpose of the report was to outline how the FDA reviews and evaluates PRO instruments that are used in clinical trials as data to support their claims of a given medical product. The end point model was created to help develop PROs, in which the concept such as the indication or supportive concept is defined and related to an end point. For example, for an indication concept of treatment of ADPKD symptoms, the patient-reported end point could be the total ADPKD symptoms score.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EAnother strategy to elicit feedback from patients is to hold a focus group. This allows patients affected by the disease to express their beliefs and perspectives regarding multiple aspects of the disease and its treatment. For example, focus groups that included 117 patients with ADPKD were held in the United States, Europe, and Japan that allowed patients to relate emotional and physical impairments caused by the disease [ERA-EDTA. 2011]. After 25% of the focus groups were held, saturation was achieved, meaning that all of the emotional and physical concepts of ADPKD were identified.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EFor the quantitative measurement of PROs, cross-sectional and longitudinal studies can be conducted.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EFrancesca Tentori, MD, Arbor Research Collaborative for Health, Ann Arbor, Michigan, USA, and Vanderbilt University Medical Center, Nashville, Tennessee, USA, described patient preferences in nephrology. Patient preferences are important because lower MCS and PCS scores are associated with mortality [Mapes DL et al. \u003Cem\u003EKidney J.\u003C\/em\u003E 2003]. Yet, the practice of routinely evaluating the quality of life (QOL) of patients varies widely across countries participating in the Dialysis Outcomes Practice Patterns Study (DOPPS).\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EThere are limitations of tools that are presently used to assess patient-centered outcomes. For example, many tools are time-consuming; therefore, only selected patients complete the assessment, and they may be too burdensome for many facilities to use on a routine basis.\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EThe DOPPS study [Rayner HC et al. \u003Cem\u003EAm J Kidney Dis.\u003C\/em\u003E 2014] evaluated patient-reported recovery time in 23 patients who underwent frequent hemodialysis (HD) and 22 controls. The study validated the recovery time tool, because the score was associated with fatigue, dialysis stress, disease stress, SF-36 subscales, and health utilities. The tool found that recovery time varied across multiple countries, with 19% to 41% stating that recovery time was \u0026lt; 2 hours and 35% to 48% indicating that recovery time was 2 to 6 hours (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). In addition, lower MCS and PCS scores were associated with longer time to recovery after HD.\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/49\/18\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Patient-Reported Recovery Time After Hemodialysis\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1125856394\u0022 data-figure-caption=\u0022Patient-Reported Recovery Time After Hemodialysis\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/49\/18\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/49\/18\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/49\/18\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15295\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-15\u0022 class=\u0022first-child\u0022\u003EPatient-Reported Recovery Time After Hemodialysis\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EAdapted from \u003Cem\u003EAm J Kid Diseases\u003C\/em\u003E, Vol 64, Rayner HC et al, Recovery Time, Quality of Life, and Mortality in Hemodialysis Patients: The Dialysis Outcomes and Practice Patterns Study (DOPPS), Pages 86\u201394, Copyright (2014), with permission from National Kidney Foundation, Inc.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EQOL and patient satisfaction are likely not the only factors that patients with kidney disease are concerned about. The EPOCH-RRT study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01952600\u0026amp;atom=%2Fspmdc%2F14%2F49%2F18.atom\u0022\u003ENCT01952600\u003C\/a\u003E] sought to identify factors that are most important to patients with kidney disease who require HD through patient interviews. These data will be compared with data gathered from the PDOPPS study, which will assess outcomes in patients undergoing peritoneal dialysis.\u003C\/p\u003E\n         \u003Cp id=\u0022p-17\u0022\u003EIn conclusion, patient preferences can be used in clinical trials to assess the effectiveness of a medical device through various patient-reported instruments. The FDA has integrated patient preferences into their assessment of medical devices to determine meaningful benefits of a product [Perrone RD et al. \u003Cem\u003EAm J Kidney Dis.\u003C\/em\u003E 2013].\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/49\/18.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzlu9d\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzlu9d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}