Pragmatic Evidence-Based Decision-Making: Using Systems Science Tools to Inform Implementation of Colorectal Cancer Screening Interventions

Background: Health administrators and other decision-makers often need to grapple with a number of challenging decisions about whether and how to implement evidence-based interventions (EBIs) aimed to improve colorectal cancer (CRC) screening and outcomes in their local populations and settings. Examples of these decisions include whether to adopt EBI(s) given the resource requirements, which EBI(s) are the best fit for the local context, and how to plan for EBI implementation. Tools are needed to help make these decisions given the best available evidence. The goal of this study was to enhance system science methodologies to support these implementation-related decisions and understand how decision-makers want to engage with and receive information about CRC screening EBIs through systems science tools. Methods: Three types of systems science tools were developed specifically to support decision-making about CRC screening EBI implementation. These tools were 1) an interactive, web-based simulation tool reporting the short-term and long-term effectiveness and cost-effectiveness of different EBIs, 2) system support maps documenting implementation activities and resource adequacy from the perspective of implementation agents, and 3) process flow diagrams describing the process steps and stakeholder roles involved in a previously implemented EBI. Individual interviews and small focus groups with diverse implementation agents and decision-makers were used to optimize these tools by assessing their information needs and preferences, decision-making goals, and prior experiences with implementation. Results: Forty-nine individuals with expertise in CRC prevention and control participated in individual or small group sessions about the utility of systems science tools for guiding EBI implementation. Broadly, they provided insight into the multiple applications of using these types of tools across implementation phases and identified multi-level opportunities to use these tools to inform implementation. Discussion: Participants advocated for using system science tools as a form of pragmatic evidence-based decision-making, highlighting their interest in making data-driven decisions but allowing for other practical considerations, such as local preferences about EBI selection, as well. While decision-makers identified many potential benefits of utilizing these types of methodologies to inform implementation research, additional research is needed to investigate how to best integrate the fields of implementation science and systems science.Doctor of Philosoph

Reach and effectiveness of a centralized navigation program for patients with positive fecal immunochemical tests requiring follow-up colonoscopy

Completion rates for follow-up colonoscopies after an abnormal fecal immunochemical test (FIT) are suboptimal in federally qualified health center (FQHC) settings. We implemented a screening intervention that included mailed FIT outreach to North Carolina FQHC patients from June 2020 to September 2021 and centralized patient navigation to support patients with abnormal FITs in completing follow-up colonoscopy. We evaluated the reach and effectiveness of navigation using electronic medical record data and navigator call logs detailing interactions with patients. Reach assessments included the proportion of patients successfully contacted by phone and who agreed to participate in navigation, intensity of navigation provided (including types of barriers to colonoscopy identified and total navigation time), and differences in these measures by socio-demographic characteristics. Effectiveness outcomes included colonoscopy completion, timeliness of follow-up colonoscopy (i.e., within 9 months), and bowel prep adequacy. Among 514 patients who completed a mailed FIT, 38 patients had an abnormal result and were eligible for navigation. Of these, 26 (68%) accepted navigation, 7 (18%) declined, and 5 (13%) could not be contacted. Among navigated patients, 81% had informational needs, 38% had emotional barriers, 35% had financial barriers, 12% had transportation barriers, and 42% had multiple barriers to colonoscopy. Median navigation time was 48.5 min (range: 24–277 min). Colonoscopy completion differed across groups – 92% of those accepting navigation completed colonoscopy within 9 months, versus 43% for those declining navigation. We found that centralized navigation was widely accepted in FQHC patients with abnormal FIT, and was an effective strategy, resulting in high colonoscopy completion rates

Characterizing chronological accumulation of comorbidities in healthy veterans: a computational approach.

Understanding patient accumulation of comorbidities can facilitate healthcare strategy and personalized preventative care. We applied a directed network graph to electronic health record (EHR) data and characterized comorbidities in a cohort of healthy veterans undergoing screening colonoscopy. The Veterans Affairs Cooperative Studies Program #380 was a prospective longitudinal study of screening and surveillance colonoscopy. We identified initial instances of three-digit ICD-9 diagnoses for participants with at least 5 years of linked EHR history (October 1999 to December 2015). For diagnoses affecting at least 10% of patients, we calculated pairwise chronological relative risk (RR). iGraph was used to produce directed graphs of comorbidities with RR > 1, as well as summary statistics, key diseases, and communities. A directed graph based on 2210 patients visualized longitudinal development of comorbidities. Top hub (preceding) diseases included ischemic heart disease, inflammatory and toxic neuropathy, and diabetes. Top authority (subsequent) diagnoses were acute kidney failure and hypertensive chronic kidney failure. Four communities of correlated comorbidities were identified. Close analysis of top hub and authority diagnoses demonstrated known relationships, correlated sequelae, and novel hypotheses. Directed network graphs portray chronologic comorbidity relationships. We identified relationships between comorbid diagnoses in this aging veteran cohort. This may direct healthcare prioritization and personalized care

Risk of COVID-19 after natural infection or vaccinationResearch in context

Summary: Background: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. Methods: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7–15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. Findings: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05–0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01–0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. Interpretation: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. Funding: National Institutes of Health

Risk of COVID-19 after natural infection or vaccinationResearch in context

Background: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. Methods: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7–15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. Findings: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05–0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01–0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. Interpretation: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. Funding: National Institutes of Health