ADS Capstone Chronicles Revised

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‭medication‬ ‭use‬ ‭module‬ ‭(HHS,‬ ‭n.d.)‬ ‭to‬ ‭represent‬ ‭the‬ ‭true‬ ‭underlying‬‭frequencies‬‭of‬ ‭adverse‬ ‭events‬ ‭for‬ ‭particular‬ ‭drugs‬ ‭in‬ ‭relation‬ ‭to‬ ‭severity‬ ‭of‬ ‭outcome.‬ ‭Data‬ ‭was‬ ‭sourced‬ ‭from‬ ‭ADReCS‬ ‭(Cai‬ ‭et‬ ‭al.,‬ ‭2015),‬ ‭FAERS,‬ ‭MEPS‬ ‭from‬ ‭2012‬ ‭to‬ ‭2019,‬ ‭PubChem‬ ‭(NCBI,‬ ‭n.d.),‬‭DrugBank‬‭(Wishart‬ ‭et‬ ‭al.,‬ ‭2018),‬ ‭Anatomical‬ ‭Therapeutic‬ ‭Chemical‬ ‭(ATC)‬ ‭system‬ ‭(World‬ ‭Health‬ ‭Organization,‬‭n.d.),‬‭and‬‭Kyoto‬‭Encyclopedia‬ ‭of‬ ‭Genes‬ ‭and‬ ‭Genomes‬ ‭(Kanehisa‬ ‭&‬ ‭Goto,‬ ‭2000).‬ ‭The‬ ‭variable‬ ‭of‬ ‭interest‬ ‭was‬ ‭clinical‬ ‭severity‬ ‭of‬ ‭ADRs:‬ ‭recovered,‬ ‭recovering,‬ ‭not‬ ‭recovered,‬ ‭resolved‬ ‭with‬ ‭sequelae,‬ ‭and‬ ‭fatal.‬ ‭Using‬ ‭a‬ ‭penalized,‬ ‭cumulative‬‭model,‬ ‭and‬ ‭common‬ ‭terminology‬ ‭criteria‬ ‭for‬ ‭adverse‬ ‭events’‬ ‭5-grade‬ ‭system‬ ‭(HHS,‬ ‭2017),‬‭the‬‭authors‬‭assigned‬‭numerical‬‭scores‬ ‭of‬ ‭1-5‬ ‭to‬ ‭the‬ ‭outcomes,‬ ‭which‬ ‭correspond‬ ‭with‬ ‭mild,‬ ‭moderate,‬ ‭severe,‬ ‭life-threatening,‬ ‭and‬ ‭death.‬ ‭The‬ ‭results‬ ‭provide‬ ‭a‬ ‭new‬ ‭framework‬ ‭of‬ ‭drug‬ ‭classification‬‭and‬‭severity‬‭that‬‭was‬‭added‬‭as‬ ‭an update to ADReCS (Cai et al., 2015).‬ ‭3.8 Current Limitations‬ ‭All‬ ‭of‬ ‭the‬ ‭models‬ ‭and‬ ‭tools‬ ‭above‬ ‭have‬ ‭similar‬ ‭themes‬ ‭of‬ ‭limitations‬ ‭which‬ ‭are‬ ‭addressed‬ ‭in‬ ‭this‬ ‭project.‬ ‭First,‬ ‭the‬ ‭models‬ ‭lack‬‭information‬‭about‬‭patient‬‭demographics‬ ‭like‬ ‭sex,‬ ‭age,‬ ‭and‬ ‭weight.‬ ‭These‬ ‭are‬ ‭often‬ ‭important‬ ‭factors‬‭to‬‭consider‬‭when‬‭it‬‭comes‬ ‭to‬ ‭adverse‬ ‭reactions‬ ‭to‬ ‭drugs,‬ ‭especially‬ ‭because‬ ‭clinical‬ ‭research‬ ‭has‬ ‭a‬ ‭historical‬ ‭gender‬‭gap‬‭and‬‭pharmacokinetics‬‭was‬‭found‬ ‭to‬ ‭be‬ ‭studied‬ ‭90x‬ ‭more‬ ‭in‬ ‭males‬ ‭than‬ ‭females‬‭in‬‭clinical‬‭trials‬‭(Staggs,‬‭et‬‭al.,‬‭n.d.).‬ ‭Figure‬ ‭3‬ ‭shows‬ ‭that‬ ‭adverse‬ ‭events‬ ‭in‬ ‭females‬ ‭are‬ ‭reported‬ ‭at‬ ‭a‬ ‭higher‬ ‭frequency‬ ‭than‬ ‭males,‬ ‭on‬ ‭average.‬ ‭The‬ ‭models‬ ‭explained‬‭above‬‭cannot‬‭be‬‭interpreted‬‭in‬‭the‬ ‭context‬ ‭of‬ ‭patients’‬ ‭needs‬ ‭and‬ ‭circumstances.‬ ‭Second,‬ ‭the‬ ‭models‬ ‭do‬ ‭not‬ ‭consider‬ ‭pricing‬ ‭of‬ ‭drugs‬ ‭as‬ ‭a‬ ‭feature.‬ ‭Controlling‬ ‭for‬ ‭demographic‬ ‭and‬ ‭economic‬ ‭features‬ ‭will‬ ‭add‬‭a‬‭biopsychosocial‬‭angle‬‭to‬

‭adverse‬ ‭drug‬ ‭events‬ ‭from‬ ‭which‬ ‭individual‬ ‭differences‬ ‭and‬ ‭financial‬ ‭burden‬ ‭can‬ ‭be‬ ‭inferred.‬ ‭Finally,‬ ‭while‬ ‭deep‬ ‭learning‬ ‭approaches‬ ‭are‬ ‭robust,‬ ‭the‬ ‭computational‬ ‭load‬ ‭and‬ ‭model‬ ‭complexity‬ ‭are‬ ‭not‬ ‭accessible,‬ ‭and‬ ‭most‬ ‭of‬ ‭the‬ ‭published‬ ‭models‬ ‭appear‬ ‭to‬ ‭be‬ ‭theoretical‬ ‭and‬ ‭static,‬ ‭instead‬ ‭of‬‭practical‬‭with‬‭model‬‭retraining‬‭to‬ ‭stay‬ ‭up‬ ‭to‬ ‭date.‬ ‭The‬ ‭model‬ ‭architecture‬ ‭cannot‬ ‭be‬ ‭interpreted‬ ‭and‬ ‭the‬ ‭high‬ ‭performance‬ ‭is‬ ‭due‬ ‭to‬ ‭modeling‬ ‭obvious‬ ‭relationships‬ ‭between‬ ‭adverse‬ ‭events‬ ‭and‬ ‭drug‬‭interactions‬‭and‬‭side‬‭effects,‬‭which‬‭are‬ ‭established‬ ‭causal‬ ‭variables‬ ‭by‬ ‭drug‬ ‭manufacturers‬ ‭and‬ ‭chemistry‬ ‭research.‬ ‭The‬ ‭models‬ ‭are‬ ‭also‬ ‭tested‬ ‭with‬ ‭the‬ ‭same‬ ‭benchmark‬ ‭datasets‬ ‭which‬ ‭limits‬ ‭the‬ ‭ability‬ ‭to‬ ‭identify‬ ‭novel‬ ‭insights.‬ ‭Most‬ ‭of‬ ‭the‬ ‭models‬ ‭have‬ ‭low‬ ‭performance‬ ‭metrics‬ ‭for‬ ‭the‬ ‭testing‬ ‭set‬ ‭for‬ ‭multiclass‬ ‭classification,‬ ‭which‬ ‭highlights‬ ‭poor‬ ‭choices‬ ‭in‬ ‭data‬ ‭cleaning,‬‭feature‬‭engineering,‬‭and‬‭balancing‬

‭outcome classes during training.‬ ‭Figure 3‬ ‭ADR‬‭Sex Representation‬

‭3.9 Addressing Limitations‬ ‭In‬ ‭this‬ ‭project,‬ ‭interpretable‬ ‭models‬ ‭are‬ ‭produced‬‭where‬‭coefficient‬‭values‬‭are‬‭useful‬ ‭and‬ ‭informative.‬ ‭Input‬ ‭features‬ ‭capture‬ ‭individual‬ ‭differences‬ ‭in‬ ‭people‬ ‭and‬ ‭economic‬ ‭features‬ ‭(U.S.‬ ‭Centers‬ ‭for‬ ‭Medicare‬ ‭&‬ ‭Medicaid‬ ‭Services‬ ‭[CMMS],‬ ‭2024)‬ ‭in‬ ‭addition‬ ‭to‬ ‭specific‬ ‭drug‬ ‭compounds.‬ ‭This‬ ‭is‬ ‭the‬ ‭first‬ ‭step‬ ‭towards‬ ‭a‬ ‭precision‬‭public‬‭health‬‭approach‬‭to‬‭drug‬‭risk‬ ‭assessment‬ ‭with‬ ‭these‬ ‭specific‬ ‭input‬ ‭features.‬

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