{"id":4567,"date":"2022-11-30T09:36:59","date_gmt":"2022-11-30T09:36:59","guid":{"rendered":"https:\/\/perseivivarium.com\/blog\/?p=4567"},"modified":"2024-02-09T09:13:59","modified_gmt":"2024-02-09T09:13:59","slug":"the-value-of-real-world-studies-with-patient-reported-outcomes-pros-and-how-to-implement-them","status":"publish","type":"post","link":"https:\/\/perseivivarium.com\/blog\/the-value-of-real-world-studies-with-patient-reported-outcomes-pros-and-how-to-implement-them\/","title":{"rendered":"The value of Real-World Studies with Patient-Reported Outcomes (PROs) and how to implement them"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.14.7&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.14.7&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.14.7&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.14.7&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;-70px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1>The value of Real-World Studies with Patient-Reported Outcomes (PROs) and how to implement them<\/h1>\n<p>by Ana-D\u00edaz Roncero, November 30, 2022<\/p>\n<p>[\/et_pb_text][et_pb_image src=&#8221;https:\/\/perseivivarium.com\/blog\/wp-content\/uploads\/2022\/11\/The-value-of-real-life-studies-with-patient-reported-data-PROs-and-how-to-implement-them-1.jpg&#8221; title_text=&#8221;The value of real-life studies with patient-reported data (PROs) and how to implement them&#8221; _builder_version=&#8221;4.14.7&#8243; _module_preset=&#8221;default&#8221; width=&#8221;85%&#8221; module_alignment=&#8221;center&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.14.7&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span style=\"font-weight: 400;\">We are becoming more accustomed to the implementation of <\/span><b>studies using Real-Life Data or Real-World Data (RWD) <\/b><span style=\"font-weight: 400;\">for the generation of evidence that helps us to better <\/span><b>understand the management of diseases and the use of treatments in real life. <\/b><span style=\"font-weight: 400;\">This information helps us gain a more concrete view of <\/span><b>the patient\u2019s daily life outside of the hospital, <\/b><span style=\"font-weight: 400;\">as well as <\/span><b>the effectiveness of the therapy prescribed by the healthcare professional, thus complementing the clinical studies. <\/b><span style=\"font-weight: 400;\">These studies have become more and more important, to the point where, between 2018 and 2019,<\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/vision-use-real-world-evidence-eu-medicines-regulation\" target=\"_blank\" rel=\"noopener\"> <span style=\"font-weight: 400;\">40% of the new applications for commercialization of products contained studies using Real-World Evidence (RWE).<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">These Real-World Studies can be generated using <\/span><b>data reported by healthcare professionals during their daily clinical practice <\/b><span style=\"font-weight: 400;\">and\/or <\/span><b>using data reported by patients (PROs)<\/b><span style=\"font-weight: 400;\">. We have already discussed the use of PROs in<\/span><a href=\"https:\/\/perseivivarium.com\/blog\/patient-reported-outcomes-pro-and-patient-reported-outcomes-measures-prom-what-are-they-and-what-do-they-provide\/\" target=\"_blank\" rel=\"noopener\"> <span style=\"font-weight: 400;\">other articles<\/span><\/a><span style=\"font-weight: 400;\">, and they are continuing to provide more value to these kinds of studies.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The PROs enable an<\/span><a href=\"https:\/\/journal.emwa.org\/observational-studies\/patient-reported-outcomes-how-useful-are-they\/\" target=\"_blank\" rel=\"noopener\"> <span style=\"font-weight: 400;\">understanding of the real current status of the patient and his or her treatment during the course of the disease<\/span><\/a><span style=\"font-weight: 400;\">, through the collection of <\/span><b>symptoms, events, quality of life, etc. directly from the patient, without intervention by the healthcare professional. <\/b><span style=\"font-weight: 400;\">In addition, the PROs also help to <\/span><b>empower the patients, enabling them to participate actively in the investigation of their disease or treatment.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">In order to do this, <\/span><b>validated <\/b><span style=\"font-weight: 400;\">digital platforms are being used more and more. These enable a <\/span><b>reduction in data loss <\/b><span style=\"font-weight: 400;\">or data entry errors, <\/span><b>immediate access to the information, an increased willingness to communicate sensitive information, and real-time tracking <\/b><span style=\"font-weight: 400;\">of compliance, as noted in<\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3227331\/\" target=\"_blank\" rel=\"noopener\"> <span style=\"font-weight: 400;\">\u201c<em>Patient-reported outcomes: A new era in clinical research<\/em>\u201d<\/span><\/a><span style=\"font-weight: 400;\">. <\/span><span style=\"font-weight: 400;\">In this way, the patient\u2019s information can be collected at the time it occurs, promoting accuracy and reliability of the data.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In addition, some studies have demonstrated that patient adherence to data collection through an electronic device is usually high, and the results appear conclusive. This was the case with a<\/span><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33951061\/\" target=\"_blank\" rel=\"noopener\"> <span style=\"font-weight: 400;\">study of patients with multiple sclerosis<\/span><\/a><span style=\"font-weight: 400;\"> that demonstrated that, in addition to <\/span><b>high adherence to the technology<\/b><span style=\"font-weight: 400;\">, the <\/span><b>changes in PROs over time enabled the prediction of clinical relapses<\/b><span style=\"font-weight: 400;\">. This suggests a potential for generating clinical research and improving the care for patients with this disease.<\/span><\/p>\n<p><a href=\"https:\/\/www.caaring.com\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Caaring<\/span><\/a><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.caaring.com\/\" target=\"_blank\" rel=\"noopener\">\u00ae<\/a>, our digital platform for patients, enables the <\/span><b>generation of research about the management of diseases in real life, using data that are 100% reported by patients. <\/b><span style=\"font-weight: 400;\">The patients report information about <\/span><b>events, therapy, quality of life\u2026 at the right time, without the need for the investigator to intervene. <\/b><span style=\"font-weight: 400;\">The results obtained from these data help to improve and adapt the way in which diseases are managed, as well as developing personalized therapies based on the patient\u2019s condition.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ultimately, Real-World Studies provide evidence about diseases and treatments that complement the results from clinical studies. The use of PROs is gaining special relevance, as they help to understand the real-time situation of the patient without intervention by the healthcare professional, thus enabling the professional to adapt the patient\u2019s care and treatment as needed. It is to be hoped that this is just the beginning, and that, through technology, their use will continue increasing in the future.<\/span><\/p>\n<p><a href=\"https:\/\/twitter.com\/hashtag\/realworldstudies?src=hashtag_click\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">#RealWorldStudies <\/span><\/a><a href=\"https:\/\/twitter.com\/hashtag\/realworlddata?src=hashtag_click\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">#RealWorldData\u00a0<\/span><\/a><a href=\"https:\/\/twitter.com\/hashtag\/PatientReportedOutcomes?src=hashtag_click\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">#PatientReportedOutcomes<\/span><\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;20px|0px|0px|0px&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;3.27.4&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h4>Share<\/h4>\n<p>[\/et_pb_text][et_pb_code _builder_version=&#8221;3.19.8&#8243; link_option_url_new_window=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_code][et_pb_team_member name=&#8221;Ana D\u00edaz-Roncero&#8221; position=&#8221;Business Development&#8221; image_url=&#8221;https:\/\/perseivivarium.com\/blog\/wp-content\/uploads\/2021\/05\/Ana-Diaz-Roncero.jpg&#8221; _builder_version=&#8221;4.14.7&#8243; link_option_url=&#8221;https:\/\/www.linkedin.com\/in\/ana-diaz-roncero-gonzalez\/&#8221; link_option_url_new_window=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Persei vivarium<\/p>\n<p>[\/et_pb_team_member][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>We are becoming more accustomed to the implementation of studies using Real-World Data (RWD) for the generation of evidence that helps us to better understand the management of diseases and the use of treatments in real life. This information helps us gain a more concrete view of the patient\u2019s daily life outside of the hospital.<\/p>\n","protected":false},"author":2,"featured_media":4594,"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":[159],"tags":[200,240,294,98],"class_list":["post-4567","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-insights","tag-patient-reported-outcomes","tag-patient-reported-data","tag-real-life-studies","tag-real-world-data"],"_links":{"self":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts\/4567","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/comments?post=4567"}],"version-history":[{"count":20,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts\/4567\/revisions"}],"predecessor-version":[{"id":4596,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts\/4567\/revisions\/4596"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/media\/4594"}],"wp:attachment":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/media?parent=4567"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/categories?post=4567"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/tags?post=4567"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}