Perpetual Data Analytics with the SDE for “Living" Clinical Guidelines

The Scientific Data Engine™ (SDE) empowers medical societies to manage regional “living” clinical guidelines by shifting data analytics to technology. 

Donna Conroy, MS, Founder & CEO, SciMar ONE, LLC 

Global COVID-19 outcomes vary for many reasons including differing healthcare capacities, infrastructure, political and socioeconomic challenges.5  A major contribution is delayed, non-existent or limited clinical guidelines. The WHO’s first global report on COVID-19 was 31 December 2019. A large majority of LMICs still have no/limited guidance including 46% of African countries.6 Wealthier regions, such as USA and EU delivered guidelines four and seven months afterwards. Dagens et al. reported on the quality of early guidelines: “Guidelines available early in the covid-19 pandemic had methodological weaknesses and neglected vulnerable groups. A framework for development of clinical guidelines during public health emergencies is needed to ensure rigorous methods and the inclusion of vulnerable populations.”7  

The difficultly of producing clinical guidelines during a pandemic is complicated by:  

1) Methodological approaches that are laborious/time-consuming for physician volunteers to implement.  

2) Data evolving quickly. Soumya Swaminathan,MD, WHO Chief Scientist, commented on the challenge of keeping up with data during COVID-19. The WHO reviewed 500-1,000 publications daily.1  

3) Organizing clinical data takes 80% of guideline development time.2,3,4  

4) Timed updates fail to acknowledge new evidence.  

Lack of/poor clinical guidelines create disparities in patient care, contributing to detrimental public health outcomes globally.    

References in supplemental document. 

A disparity exists in COVID-19 guideline development from medical societies globally. We seek to help all medical societies, especially LMICs, develop and maintain regionally appropriate “living” guidelines for emerging diseases beginning with COVID-19. The focus is on emerging diseases impacting global public health, requiring up-to-date clinical guidelines for equitable treatment and management of patients. This global need requires AI-powered technology to consistently analyze data and notify committees of potential guidelines updates aligned to specific regional needs.    

Partnering with European Society of Clinical Microbiology & Infectious Disease (ESCMID), the SDE will  meet this need. In this research-oriented process, SciMar and ESCMID will compare human alone vs. human+SDE technology in the development of COVID-19 clinical guidelines using the GRADE-ADOLOPMENT approach. Early discussions established a baseline of application needs. Touchpoints throughout the R&D allow for feedback, ongoing needs and recommendations for improving SDE transition. 

Upon development, the Guideline SDE platform will be offered to medical societies globally for regional guideline development. The SDE strives to replace redundant, time-consuming tasks associated with guideline development with AI that keeps pace with new data. Success allows medical societies to adopt regionally-appropriate “living” clinical guidelines for emerging diseases and improve global response to public health challenges. 

Trinity Challenge grant monies establish a philanthropic arm of SciMar that will be self-sustaining by year four.

We have agreed to build the Guideline SDE in a research-oriented way with our partner, The European Society of Clinical Microbiology and Infectious Diseases (ESCMID). ESCMID has agreed to test the platform during its production. 

The primary research questions relate to the evaluation of human alone vs. human + AI in a head-to-head study comparing development of COVID-19 clinical guidelines congruent with GRADE-ADOLOPMENT approach. We will publish interim results with ESCMID in an abstract. Following the completion of research and development, we will publish a summary of results in a peer-reviewed publication.  

If the Guideline SDE meets predetermined goals and is deemed successful in developing and maintaining “living” clinical guidelines, SciMar will continue to develop new emerging disease-specific SDEs. Revenue from pharmaceutical focused drug development SDEs will subsidize this readily assessable public-good arm of SciMar serving medical societies guideline development committees for FREE.    

The European Society of Clinical Microbiology and Infectious Disease (ESCMID) is a well-known and respected medical society with members from all European countries and all continents. ESCMID reaches more than 8,500 individual and 30,000 affiliated members around the world who are microbiologists and infectious disease specialists.   

ESCMID is responsible for developing evidence-based COVID-19 clinical guidelines. In partnership with ESCMID, we will compare human alone vs. human + AI technology in the development of COVID-19 clinical guidelines using GRADE-ADOLOPMENT approach.   

The potential impact of incorporating an Evidence to Decision (EtD) framework in an AI-assisted technology should allow for rapid development of regionally based, living COVID-19 guidelines. 

Providing medical practitioners expedited access to current and validated clinical knowledge, typically found in guidelines, should advance patient care overall. Specifically, we hope to increase knowledge in LMICs still suffering effects of the COVID-19 pandemic. 

The potential to develop and maintain “living” clinical guidelines that keep pace with scientific advancements, while using validated EtD framework could create a new guideline development model for managing future pandemics and emerging diseases that positively impacts global patient care.  

SciMar will scale the Guideline SDE bi-directionally by:  

1) Building SDEs for new and existing emerging diseases that are scientifically complicated and impacting high volumes of patients globally with unmet medical needs, and 

2) Offering the system to more medical societies around the world with a focus on low- & middle-income countries (LMIC). This will increase the impact of the system to millions of patients suffering from various diseases located in different parts of the world.  

Our yearly plan to scale the SDE is as follows:  

2021-2022: Product Development: Build the first Guideline SDE for COVID-19 in partnership with ESCMID. Concurrently, SciMar’s LMIC resources will begin to identify regions with the highest clinical guideline needs and explore opportunities to bring this technology forward.  

2022-2023: Growth: When complete, offer the COVID-19 SDE to other medical societies around the world developing / updating COVID-19 clinical guidelines- with a focus on LMIC. Begin testing the guideline development SDE in another emerging disease to determine and potentially improve the data model’s ability to adapt quickly to other diseases (testing pandemic preparedness).  

2023-2024: Scale Bi-directionally: Continue to develop and share other disease-specific SDEs with medical societies as needed around the world, including LMIC. 

In partnership with ESCMID, we will conduct a direct comparison of humans vs. humans + SDE in guideline development and maintenance, and measure twelve endpoints.  

The endpoints test the ability of human plus SDE across three variables: SPEED, ACCURRACY and COST to complete four tasks:  

1) Identification of relevant data meeting pre-determined criteria  

2) Sorting of data congruent with inclusion/exclusion criteria  

3) Data analysis: grading of clinical data  

4) Keeping pace with new clinical evidence (for earlier updates to COVID-19 clinical guidelines).  

Results of 12 assessments (3 variables x 4 tasks) will answer which components of EtD framework can be successfully implemented by AI technology to reduce time challenges of guideline development and its ability to provide timely information for regionally appropriate “living” guidelines.  

These results will be generated twice - at initial guideline development and at the study end, approximately one year later to account for the fourth task: keeping pace with new clinical evidence.  

Results from primary findings will be used to answer secondary questions in year 2-3 around the global impact (specifically in LMICs) of living guidelines in a follow-up study highlighting successes and challenges incorporating the Guideline SDE by region. 

Three potential perceptual barriers may include: 

1) Perception that the intention of the system is to replace doctors and methodologists vs. the intention to assist them in completing redundant data analytical tasks of data identification, parsing and tagging. 

2) Perception that bias is contained in the system 

3) Perceptual concern that the system’s output (data and the analysis) may not be as good or comprehensive as a trained methodologist.  

We plan to overcome these perceptual barriers by conducting the pilot in a research-oriented method to provide metrics. We intend to publish findings in well-known journals to alleviate and overcome perceptual barriers.  

Beyond perceptual barriers, we anticipate cultural barriers in certain areas of the world in “allowing” adoption of the system into a country. Whether these barriers are truly cultural or political, SciMar will work with physicians within medical societies to help bring education and understanding of the purity and transparency of Guideline SDE goals: to reduce emerging disease among a country’s population.

Microsoft for Startups 

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We seek grant funds from The Trinity Challenge to transition our current SDE technology and build a sustainable philanthropic arm serving the needs of global medical societies’ guideline development committees.  

By year four, profits from our main revenue source will subsidize this readily assessable public-good / philanthropic arm of SciMar allowing us to provide the Guideline SDE to medical societies for free.    

Since our initial application, Microsoft has selected the pharma drug development SDE for the Microsoft for Startups program. Our advocate from the program is helping us navigate the Microsoft ecosystem to gain enterprise level support for the pharma drug development SDE, providing Azure credits and a variety of other resources to assist us. Recently, we were introduced to Microsoft’s philanthropic arm. There is a possibility of Microsoft providing similar resources for the Guideline SDE if we were to win grant money from The Trinity Challenge. 

Partnering with the Bill & Melinda Gates Foundation would be valuable from a consultative perspective, as the foundation has experience in physically meeting with locals from LMICs to understand regional needs. We would appreciate consultative session(s) with the organization to understand best practices and/or key learnings from their collective knowledge. We would apply these learnings when we speak to medical experts/health authorities tasked with/involved in incorporation or development of clinical guidelines.  

Finally, it would be appreciated if GSK adopts the drug development SDE while ESCMID pilots the Guideline SDE to help us better understand stakeholder synergies.