Therapeutics https://evidenceaccelerator.org/ en A Community of “Accelerators” https://evidenceaccelerator.org/blog/community-accelerators <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--title--blog-post.html.twig x field--node--title.html.twig * field--node--blog-post.html.twig * field--title.html.twig * field--string.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--title.html.twig' --> <span class="field field--name-title field--type-string field--label-hidden">A Community of “Accelerators”</span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--title.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-date--blog-post.html.twig * field--node--field-date.html.twig * field--node--blog-post.html.twig * field--field-date.html.twig * field--datetime.html.twig x field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field.html.twig' --> <div class="field field--name-field-date field--type-datetime field--label-hidden field__item"> <!-- THEME DEBUG --> <!-- THEME HOOK: 'time' --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/time.html.twig' --> <time datetime="2021-09-01T12:00:00Z" class="datetime">Wednesday, September 01, 2021</time> <!-- END OUTPUT from 'core/themes/classy/templates/field/time.html.twig' --> </div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--uid--blog-post.html.twig x field--node--uid.html.twig * field--node--blog-post.html.twig * field--uid.html.twig * field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--uid.html.twig' --> <span class="field field--name-uid field--type-entity-reference field--label-hidden"> <!-- THEME DEBUG --> <!-- THEME HOOK: 'username' --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/user/username.html.twig' --> <span>mmcnamara</span> <!-- END OUTPUT from 'core/themes/classy/templates/user/username.html.twig' --> </span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--uid.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--created--blog-post.html.twig x field--node--created.html.twig * field--node--blog-post.html.twig * field--created.html.twig * field--created.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--created.html.twig' --> <span class="field field--name-created field--type-created field--label-hidden">Wed, 09/01/2021 - 11:03</span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--created.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-authors--blog-post.html.twig * field--node--field-authors.html.twig * field--node--blog-post.html.twig * field--field-authors.html.twig x field--text-long.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--text-long.html.twig' --> <div class="clearfix text-formatted field field--name-field-authors field--type-text-long field--label-hidden field__item"><p><strong>Authors:</strong><br /><em>Aloka G. Chakravarty, PhD, </em>Senior Statistical Advisor, Office of the Commissioner, U.S. Food and Drug Administration<em> <br /> Tamar Lasky, PhD, FISPE, </em>Senior Advisor for Real-World Evidence, Office of the Commissioner, U.S. Food and Drug Administration <em>    </em><br /><span><span><em>Amar Bhat, PhD</em></span></span>, Chief Operating Officer, Reagan-Udall Foundation for the FDA</p></div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--text-long.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--body--blog-post.html.twig * field--node--body.html.twig * field--node--blog-post.html.twig * field--body.html.twig x field--text-with-summary.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--text-with-summary.html.twig' --> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p><span><span><span>In June of 2021, the Therapeutics Parallel Analysis (TxPA) work group of the COVID-19 Evidence Accelerator paused to conduct a retrospective or “retro”. For those of you who are unfamiliar with the expression, a retro is an opportunity to review the work of a previous cycle or “sprint” in Agile terminology. A retro allows the Evidence Accelerator community the opportunity to step back and see how far we have come, what went well, and where we could make improvements. </span></span></span></p> <p><span><span><span>The retro revealed a few themes which we plan to discuss in some detail in a series of blog posts.  This first article examines the development of “Community” in the Evidence Accelerator. </span></span></span></p> <p><span><span><span>Our first TxPA workstream focused on the question of hydroxychloroquine use in COVID-19 patients concluded in the fall of 2020 resulting in our first </span><a href="https://doi.org/10.1371/journal.pone.0248128"><span>publication</span></a><span>.  The TxPA work group has made significant progress since the Fall of 2020, focusing on our two current workstreams: Natural History of Coagulopathy and Remdesivir. The questions that we chose to tackle were developed collaboratively between FDA and the broader Evidence Accelerator community, specifically: </span></span></span></p> <ul><li><span><span><span>What is the natural history of coagulopathy in COVID-19 patients?</span></span></span></li> <li><span><span><span>Can we assess the effectiveness of remdesivir in hospitalized COVID-19 patients?</span></span></span></li> </ul><p><span><span><span>To address these questions, we worked with a community of volunteer groups known collectively as “Accelerators” with access to datasets, tools, and/or methodologies to build a robust and credible real-world evidence-base. Each group (Table 1) chose which question set they would like to tackle, based on their own interests and available resources. By working with groups willing to conduct these analyses in parallel using a common analytical plan, our goal was to gather quick insights into the management and treatment of patients with COVID-19. </span></span></span></p> <img alt="table 1" data-entity-type="file" data-entity-uuid="5f31d974-f48e-4e75-bcb2-7263b12d063e" height="310" src="/sites/default/files/inline-images/retro%20chart%203.jpg" width="606" class="align-center" loading="lazy" /><p> </p> <p><span><span><span>Each member of this newly formed community came to the group with different motivations; the wish to contribute to addressing the public health emergency, a desire to learn from peers regarding how they would tackle common problems, or an opportunity to showcase and sharpen their skills and expertise applying the most recent methods of real-world evidence. Below are some of the lessons learned from this process from the perspective of the community. </span></span></span></p> <ol><li><span><span><span><strong>Agreeing on a common analytical plan takes time.</strong> The TxPA community has substantial skills and expertise in designing and executing observational studies using real-world data. The teams authoring the analytical plans needed to iterate with others within the community to develop common plans, one for each question set. The newness of this disease, combined with the still-evolving methods and the varied level of expertise of those in the community meant that we needed to spend time to develop and refine these analytical plans and protocols. Over the course of several weeks, the groups reviewed multiple drafts and weighed the costs and benefits of different statistical approaches and methodologies. </span></span></span></li> <li><span><span><span><strong>Each dataset presents its own unique challenges.</strong> By sharing experiences, the community was able to accelerate and share learnings amongst themselves. Groups with one type of dataset, e.g., electronic health records, appreciated hearing about the challenges and solutions of using different types of data, e.g., Chargemaster data or insurance claims. An example was medication use definitions, i.e., how did various groups identify the medications used in their analysis, whether medications of primary interest, e.g., remdesivir, or concomitant medications such as anticoagulants. While some groups used NDC codes, others used RxNORMS, or simple text searches. See our <a href="https://www.evidenceaccelerator.org/blog/covid-19-evidence-accelerator-workgroup-coordinate-medication-use-definitions-across-evidence">January 28, 2021 blog</a> for more on this particular challenge.</span></span></span></li> <li><span><span><span><strong>Contributors vary in how much time and resources they can devote.</strong> Along the way, some groups had to drop out or divert personnel as they realized that their other obligations precluded them from continuing. Lack of funding for the groups may have also been a factor for other groups, although other factors were certainly at play. Bandwidth concerns also impacted the speed with which results were generated and analyzed. As a result, the groups shared their results over a wider timeframe than originally anticipated. This was a particularly useful insight which we will need to consider when planning future research activities.</span></span></span></li> </ol><p><span><span><span>One reoccurring theme was the value of community, and having a venue for an exchange of ideas, knowledge, and even problems. In the fast-paced world of scientists responding to a fast-moving pandemic, access to fellow scientists doing different work, and approaching problems in varied ways was exciting, inspiring and invaluable.</span> <span>We will look to incorporate these and other lessons as we evolve the Evidence Accelerator and plan future research activities. </span></span></span></p> <p><span><span><span>Additional lessons learned from the retro, grouped along other themes, will be explored in future posts. Stay tuned!</span></span></span></p></div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--text-with-summary.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-blog-tags--blog-post.html.twig * field--node--field-blog-tags.html.twig * field--node--blog-post.html.twig * field--field-blog-tags.html.twig x field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> <div class="field field--name-field-blog-tags field--type-entity-reference field--label-hidden field--entity-reference-target-type-taxonomy-term clearfix field__items"> <div class="field__item"><a href="/taxonomy/term/15" hreflang="en">Therapeutics</a></div> <div class="field__item"><a href="/taxonomy/term/30" hreflang="en">FDA</a></div> <div class="field__item"><a href="/taxonomy/term/33" hreflang="en">Hydroxychloroquine</a></div> </div> <!-- END OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-topic--blog-post.html.twig * field--node--field-topic.html.twig * field--node--blog-post.html.twig * field--field-topic.html.twig x field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> <div class="field field--name-field-topic field--type-entity-reference field--label-above field--entity-reference-target-type-taxonomy-term clearfix"> <div class="field__label">Topic</div> <div class="field__items"> <div class="field__item"><a href="/taxonomy/term/20" hreflang="en">Data/data analytics</a></div> <div class="field__item"><a href="/taxonomy/term/23" hreflang="en">Real world evidence</a></div> </div> </div> <!-- END OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> Wed, 01 Sep 2021 15:03:12 +0000 mmcnamara 95 at https://evidenceaccelerator.org COVID-19 Evidence Accelerator workgroup to coordinate medication use definitions across Evidence Accelerator data partners https://evidenceaccelerator.org/blog/covid-19-evidence-accelerator-workgroup-coordinate-medication-use-definitions-across-evidence <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--title--blog-post.html.twig x field--node--title.html.twig * field--node--blog-post.html.twig * field--title.html.twig * field--string.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--title.html.twig' --> <span class="field field--name-title field--type-string field--label-hidden">COVID-19 Evidence Accelerator workgroup to coordinate medication use definitions across Evidence Accelerator data partners</span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--title.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-date--blog-post.html.twig * field--node--field-date.html.twig * field--node--blog-post.html.twig * field--field-date.html.twig * field--datetime.html.twig x field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field.html.twig' --> <div class="field field--name-field-date field--type-datetime field--label-hidden field__item"> <!-- THEME DEBUG --> <!-- THEME HOOK: 'time' --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/time.html.twig' --> <time datetime="2021-01-28T12:00:00Z" class="datetime">Thursday, January 28, 2021</time> <!-- END OUTPUT from 'core/themes/classy/templates/field/time.html.twig' --> </div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--uid--blog-post.html.twig x field--node--uid.html.twig * field--node--blog-post.html.twig * field--uid.html.twig * field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--uid.html.twig' --> <span class="field field--name-uid field--type-entity-reference field--label-hidden"> <!-- THEME DEBUG --> <!-- THEME HOOK: 'username' --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/user/username.html.twig' --> <span>webmin</span> <!-- END OUTPUT from 'core/themes/classy/templates/user/username.html.twig' --> </span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--uid.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--created--blog-post.html.twig x field--node--created.html.twig * field--node--blog-post.html.twig * field--created.html.twig * field--created.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--node--created.html.twig' --> <span class="field field--name-created field--type-created field--label-hidden">Thu, 01/28/2021 - 16:19</span> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--node--created.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-authors--blog-post.html.twig * field--node--field-authors.html.twig * field--node--blog-post.html.twig * field--field-authors.html.twig x field--text-long.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--text-long.html.twig' --> <div class="clearfix text-formatted field field--name-field-authors field--type-text-long field--label-hidden field__item"><p><strong>Authors:</strong><br /><span><span><span><em>Tamar Lasky, PhD, FISPE, </em></span></span></span><span><span><span><span><span>Senior Advisor for Real-World Evidence, </span></span></span></span></span><span><span><span><span><span>Office of the Commissioner, </span></span></span></span></span><span><span><span>U.S. Food and Drug Administration</span></span></span><br /><span><span><span><em><span>Aloka G. Chakravarty, PhD, </span></em>Senior Statistical Advisor (Act.), Office of the Commissioner, U.S. Food and Drug Administration</span></span></span><em>       </em></p></div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--text-long.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--body--blog-post.html.twig * field--node--body.html.twig * field--node--blog-post.html.twig * field--body.html.twig x field--text-with-summary.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'core/themes/classy/templates/field/field--text-with-summary.html.twig' --> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p>During a recent COVID-19 Evidence Accelerator (EvAcc) Therapeutics Parallel Analysis meeting<sup><a href="#_ftn1" name="_ftnref1" id="_ftnref1"><span><span><span><span><span>1</span></span></span></span></span></a></sup> we saw the synergy and creativity that arises when multiple partners work on the same data challenges. As all of us listened (and have been listening) to data partners express frustration over wrangling medication use codes, an idea emerged: “Why don’t we all put our heads together on this issue and solve it together?” Such collaboration is a goal of the Evidence Accelerator, and a key data challenge in real-world studies is the inclusion of medication use data (from prescribing to dispensing).<img alt="Why don't we all put our heads together on this issue and solve it together?" data-entity-type="file" data-entity-uuid="2d599cc0-f015-4739-93ab-47ead0e18eaa" height="229" src="/sites/default/files/inline-images/PullOutQuote3_0.jpg" width="573" class="align-right" loading="lazy" /></p> <p><span><span><span>Medication lists enter the EvAcc analyses of real-world data (RWD) when, for example, we consider treatments a patient may have received in the progression of the disease or when we describe the course of a specific treatment and collect information on other medical conditions and medications that may be relevant to our specific study question. (These are often covariates or potential confounders in propensity score modeling.) The task is daunting because there are many medications, formulations, coding systems, and opportunities for misspellings, non-standard abbreviations, truncations of names, and other issues. In short, data partners have been putting hours of time into getting the medication use data in shape.</span></span></span></p> <p><span><span><span>The data challenge is complex. One of the Accelerators (Keith Marsolo, Duke University) explained, “Within the [Electronic Health Record] EHR, information on medication exposure can be found in four broad domains: prescribing/orders, procedures, administrations, and dispensing. (Self-reported medications and those delivered in home health visits tend to be slotted into one of those areas.)  Depending on the study question, it may be necessary to look in any/all of those domains to gain a complete understanding of exposure. (A caveat: The domains may be incomplete. For example, a health system may only have dispensing information for surgery patients that covers the 90 days prior to surgery.)  Data within these domains will be coded in a variety of formats: CPT/HCPCS for procedures, NDC for dispensing, NDC or RxNorm for administrations (depending on site) and RxNorm for prescribing/orders.”</span></span></span></p> <p><span><span><span>There are, of course, additional complexities related to the coding standard that are enough to make your head spin, underscoring that the EvAcc community needs to work together to standardize approaches to medication use information and agree on practices. Fortunately, the EvAcc community has a wealth of expertise from which to draw!</span></span></span></p> <p><span><span><span>Some points to consider: </span></span></span></p> <p><span><span><span>Medication use data includes prescribing/orders, procedures, administrations, and dispensing, as well as self-reported use and other events. These considerations can, and should, be incorporated in our conceptual and operational definitions and, as Keith so rightly points out, will vary with the research context. For example, when we are describing practice, we may rely on the prescribing orders; when we are using medications to indicate co-morbidities, we may combine prescribing and physician orders with self-report, administrations, dispensing, etc.; and when we are seeking to describe the result of medication exposure, we may prefer administration and dispensing data. These will vary with the specific question and the state of the field. Regarding Keith’s point about the multiple coding systems, it will be useful to explore how others have developed code to use the medication data in different types of analyses. And then, perhaps, we could tackle additional nuances and complexities.</span></span></span></p> <p><span><span><span>Looking forward to seeing the result of this collaboration.</span></span></span></p> <p>The <em>ad hoc</em> Medication Use Definitions Working Group kicked off on February 1. The limited duration workgroup will develop resources to guide use of medication data in the EvAcc, and to share those resources with the broader research community. This effort is intended to save time and energy, allowing us to focus on critical scientific questions. Contact <a href="mailto:EvidenceAccelerator@reaganudall.org">EvidenceAccelerator@reaganudall.org</a> for more information.</p> <p><br /><sup><a href="#_ftnref1" name="_ftn1" id="_ftn1">1</a></sup><span><sup> The COVID-19 Evidence Accelerator includes two primary objectives: 1) convening the COVID-19 real-world data community to share lessons learned and keep pace with new developments and 2) pursuing discrete, prioritized research questions in our Parallel Analysis format. In the Parallel Analysis approach, data partners agree on a common protocol and query their data sources to generate information, which is then presented side-by-side, or in parallel</sup>.</span></p> <hr /></div> <!-- END OUTPUT from 'core/themes/classy/templates/field/field--text-with-summary.html.twig' --> <!-- THEME DEBUG --> <!-- THEME HOOK: 'field' --> <!-- FILE NAME SUGGESTIONS: * field--node--field-blog-tags--blog-post.html.twig * field--node--field-blog-tags.html.twig * field--node--blog-post.html.twig * field--field-blog-tags.html.twig x field--entity-reference.html.twig * field.html.twig --> <!-- BEGIN OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> <div class="field field--name-field-blog-tags field--type-entity-reference field--label-hidden field--entity-reference-target-type-taxonomy-term clearfix field__items"> <div class="field__item"><a href="/taxonomy/term/15" hreflang="en">Therapeutics</a></div> <div class="field__item"><a href="/taxonomy/term/30" hreflang="en">FDA</a></div> <div class="field__item"><a href="/taxonomy/term/36" hreflang="en">real world evidence</a></div> <div class="field__item"><a href="/taxonomy/term/35" hreflang="en">data analytics</a></div> </div> <!-- END OUTPUT from 'themes/custom/corporateplus/templates/field--entity-reference.html.twig' --> Thu, 28 Jan 2021 21:19:24 +0000 webmin 98 at https://evidenceaccelerator.org