An Informatics Consult approach for generating clinical evidence for treatment decisions

Abstract

An Informatics Consult has been proposed in which clinicians request novel evidence from large scale health data resources, tailored to the treatment of a specific patient, with return of results in clinical timescales. However, the availability of such consultations is lacking. We seek to provide an Informatics Consult for a situation where a treatment indication and contraindication coexist in the same patient, i.e., anti-coagulation use for stroke prevention in a patient with both atrial fibrillation (AF) and liver cirrhosis. We examined four sources of evidence for the effect of warfarin on stroke risk (efficacy) or all-cause mortality (safety) from: (i) randomised controlled trials (RCTs), (ii) meta- analysis of prior observational studies, (iii) trial emulation (using population electronic health records (N = 3,854,710) and (iv) genetic evidence (Mendelian randomisation). We developed prototype forms to request an Informatics Consult and return of results in electronic health record systems. We found 0 RCT reports and 0 trials recruiting for patients with AF and cirrhosis. We found broad concordance across the three new sources of evidence we generated. Meta-analysis of prior observational studies showed that warfarin use was associated with lower stroke risk (hazard ratio [HR] = 0.71). In a target trial emulation, warfarin was associated with lower all-cause mortality (HR = 0.61) and ischaemic stroke (HR = 0.27). Mendelian randomisation served as a drug target validation where we found that lower levels of vitamin K1 (warfarin is a vitamin K1 antagonist) are associated with lower stroke risk. A pilot survey with an independent sample of 34 clinicians revealed that 85% of clinicians found information on prognosis useful and that 79% thought that they should have access to the Informatics Consult as a service within their healthcare systems. We identified candidate steps for automation to scale evidence generation and to accelerate the return of results within clinical timescales.

Developing learning health systems in the UK: Priorities for action

“…Surveys of clinicians using the platform showed that 85% found information on prognosis useful and 79% thought they should have access to the platform as a service. 67 By providing information on the prevalence of conditions as well as information on the safety and efficacy of a particular medication, it is hoped that this will stimulate further initiatives to generate new analyses for a wider range of prognostic outcomes. Given the rising trends of multimorbidity, especially in younger people, the Informatics Consult may contribute to the creation of a knowledge base generated from real-world datasets to address the current gaps in randomised control trials (arising from the exclusion of patients with comorbid conditions).…”

The Development of a Proof-of-Concept Physician-Driven Informatics Consult System for the Individualized Treatment of Patients with Orthopaedic Conditions

“…Additionally, with advances in data interoperability, this feature could be bene cial for physicians in small, remote practices who do not routinely treat a high volume of PHF injuries and could bene t from peer comparison. (20) Figure 1 displays the Treatment Comparators data visualizations. For the reference class displayed in Fig.…”

“…Despite anticipated modi cations to future iterations and data sources, there is enthusiasm among physicians for ICSCEDIT in its current form and tools with similar functionality. (20) Though, beyond just physicians, we believe that patients, health system administrators, and payers all would be interested users of a system like ICSCEDIT to guide individual and population health-level treatment decisions. ICSCEDIT and similar systems bring incredible value to assist physicians when faced with di cult treatment decisions.…”

“…(19) Furthermore, informatics consult services currently employ a team of researchers and data scientists to eld requests and return responses to physicians within a number of days. We believe that we can build upon the informatic consult service concept (19,20) to develop an informatics consult system to allow for physicians to perform dynamic searches and receive immediate data summaries at the point of care when treatment decisions are being made. Therefore, our objective is to demonstrate proof-of-concept of a physician-driven informatics consult system that has the key design and functional elements that will maximize usability, and drive improvements in the quality and safety of orthopaedic care.…”

Comparing clinical trial population representativeness to real-world populations: an external validity analysis encompassing 43 895 trials and 5 685 738 individuals across 989 unique drugs and 286 conditions in England

“…For example, a patient with atrial fibrillation might wish to know how anticoagulant use might affect their liver cirrhosis, but because most patients with hepatic conditions are underrepresented or excluded in cardiovascular RCTs, this information is scarce. 12 Similarly, treatment risk or benefit information is important to clinicians as a factor to consider when making clinical treatment decisions, which will affect a patient's health outcome, but this is also scarce. Furthermore, vulnerabilities tend to overlap, the prevalence of chronic conditions increases with age, and drugs are prescribed for each condition separately.…”