Institutionally chartered Data and Safety Monitoring Boards: structured approaches to assuring participant safety in clinical research

Data and Safety Monitoring Boards (DSMBs) derived from the need to monitor large federally funded multi-center clinical trials and evolved to include commercial and other large and complex trials. Eventually, academic health centers also created institutionally focused trial monitoring mechanisms. The basic general principles that define traditional DSMBs extend to the institutional level. The primary responsibilities are assuring safety of the participants, preserving the integrity of the trial, and ensuring the reliability of the results. Institutionally chartered DSMBs meet these responsibilities but usually have fewer members, have a structure specific to the needs of the trial, are more focused and/or have different scope reviewing smaller, single site, higher risk, and investigator-initiated studies and are flexible to accommodate institution-specific requirements and approaches. Their purpose is to meet the responsibilities of oversight for safety and data integrity, ensure proper study design, rigor and conduct, as well as provide statistical support appropriate to the setting of the research. Academic health centers should recognize the importance and existence of institution level safety and data monitoring and provide support as much as possible. Investigators should have sufficient resources available to assemble DSMBs. The Clinical and Translational Science Awards Collaborative DSMB Workgroup provides an online manual to assist investigators.

Patients Contributing to their Visit Notes: A Mixed Methods Evaluation of Pilot Experiments with OurNotes (Preprint)

BACKGROUND Patients are uniquely positioned to document both their subjective experiences and goals for a medical encounter. OBJECTIVE To assess the effects of 12-month pilot interventions of co-generated visit notes. METHODS Patients at 6 primary care practices in 4 academic health centers were asked to provide unstructured interval histories and an agenda for discussion prior to a scheduled primary care visit. Clinicians were invited to incorporate these submissions into visit notes, thereby generating “OurNotes.”174 providers participated, and 1,962 patients submitted at least 1 pre-visit form. RESULTS 76 providers (44%) and 525 patients (27%) responded; 74 providers and 321 patients remembered the OurNotes forms and answered survey questions. Patients found the history (81%) and agenda (89%) questions not difficult to answer; >90% thought sending answers before the visit a good idea; 69% thought the questions helped them prepare; we found no differences for patients reporting chronic conditions. Patients wanted to learn how to write better answers and to know whether their submissions were read. Clinicians thought interim histories (93%) and agendas (97%) a good idea; 69% usually/always incorporated them into notes; 37% thought they saved time in visit length; 53% reported no change. They suggested improving notifications when forms arrived, simplifying inserting submissions into notes, and teaching patients how to prepare submissions. All sites decided to continue with OurNotes after the pilots. CONCLUSIONS Overall, both patient and clinician respondents viewed the pilot interventions positively and encouraged further development, and each site chose to continue the practice. CLINICALTRIAL N/A

Development of a COVID-19 Application Ontology for the ACT Network

Clinical data networks that leverage large volumes of data in electronic health records (EHRs) are significant resources for research on coronavirus disease 2019 (COVID-19). Data harmonization is a key challenge in seamless use of multisite EHRs for COVID-19 research. We developed a COVID-19 application ontology in the national Accrual to Clinical Trials (ACT) network that enables harmonization of data elements that that are critical to COVID-19 research. The ontology contains over 50,000 concepts in the domains of diagnosis, procedures, medications, and laboratory tests. In particular, it has computational phenotypes to characterize the course of illness and outcomes, derived terms, and harmonized value sets for SARS-CoV-2 laboratory tests. The ontology was deployed and validated on the ACT COVID-19 network that consists of nine academic health centers with data on 14.5M patients. This ontology, which is freely available to the entire research community on GitHub at https://github.com/shyamvis/ACT-COVID-Ontology, will be useful for harmonizing EHRs for COVID-19 research beyond the ACT network.

Diversity, Equity, and Inclusion Efforts at a Departmental Level: Building a Committee as a Vehicle for Advancing Progress

Academic Health Centers (AHCs) across the nation are experiencing a reawakening to the importance of Diversity, Equity, and Inclusion (DEI). Such work impacts both employees and patients served by healthcare institutions. Yet, for departments without previously existing formal channels for this work, it is not always apparent where to begin. The current manuscript details a process for creating a committee as a vehicle for championing DEI efforts at thedepartment level within an AHC. The authors present a six-step model for forming a DEI committee and progress monitoring measures to remain accountable to identified objectives. In each step, the authors provide examples of their work with the goal for readers to tailor and applyeach step to their own departments’ DEI efforts. The current paper also identifies lessons learned with regard to barriers and facilitators of department-level DEI work. Reflections and next steps for DEI work beyond the proposed model are also discussed.

Strategies and settings of clinical pharmacogenetic implementation: a scoping review of pharmacogenetics programs

Pharmacogenetic (PGx) literature has shown beneficial outcomes in safety, efficacy and cost when evidence-based gene-drug decision making is incorporated into clinical practice. PGx programs with successfully implemented clinical services have been published in a variety of settings including academic health centers and community practice. The primary objective was to systematically scope the literature to characterize the current trends, extent, range and nature of clinical PGx programs. Forty articles representing 19 clinical PGx programs were included in analysis. Most programs are in urban, academic institutions. Education, governance and workflow were commonly described while billing/reimbursement and consent were not. This review provides an overview of current PGx models that can be used as a reference for institutions beginning the implementation process.

Development of a COVID-19 Application Ontology for the ACT Network

Clinical data networks that leverage large volumes of data in electronic health records (EHRs) are significant resources for research on coronavirus disease 2019 (COVID-19). Data harmonization is a key challenge in seamless use of multisite EHRs for COVID-19 research. We developed a COVID-19 application ontology in the national Accrual to Clinical Trials (ACT) network that enables harmonization of data elements that that are critical to COVID-19 research. The ontology contains over 50,000 concepts in the domains of diagnosis, procedures, medications, and laboratory tests. In particular, it has computational phenotypes to characterize the course of illness and outcomes, derived terms, and harmonized value sets for SARS-CoV-2 laboratory tests. The ontology was deployed and validated on the ACT COVID-19 network that consists of nine academic health centers with data on 14.5M patients. This ontology, which is freely available to the entire research community on GitHub at https://github.com/shyamvis/ACT-COVID-Ontology, will be useful for harmonizing EHRs for COVID-19 research beyond the ACT network.