Number needed to vaccinate with a COVID-19 booster to prevent a COVID-19-associated hospitalization during SARS-CoV-2 Omicron BA.1 variant predominance, December 2021-February 2022, VISION Network: a retrospective cohort study.

Background: Understanding the usefulness of additional COVID-19 vaccine doses-particularly given varying disease incidence-is needed to support public health policy. We characterize the benefits of COVID-19 booster doses using number needed to vaccinate (NNV) to prevent one COVID-19-associated hospitalization or emergency department encounter. Methods: We conducted a retrospective cohort study of immunocompetent adults at five health systems in four U.S. states during SARS-CoV-2 Omicron BA.1 predominance (December 2021-February 2022). Included patients completed a primary mRNA COVID-19 vaccine series and were either eligible to or received a booster dose. NNV were estimated using hazard ratios for each outcome (hospitalization and emergency department encounters), with results stratified by three 25-day periods and site. Findings: 1,285,032 patients contributed 938 hospitalizations and 2076 emergency department encounters. 555,729 (43.2%) patients were aged 18-49 years, 363,299 (28.3%) 50-64 years, and 366,004 (28.5%) ≥65 years. Most patients were female (n = 765,728, 59.6%), White (n = 990,224, 77.1%), and non-Hispanic (n = 1,063,964, 82.8%). 37.2% of patients received a booster and 62.8% received only two doses. Median estimated NNV to prevent one hospitalization was 205 (range 44-615) and NNV was lower across study periods for adults aged ≥65 years (110, 46, and 88, respectively) and those with underlying medical conditions (163, 69, and 131, respectively). Median estimated NNV to prevent one emergency department encounter was 156 (range 75-592). Interpretation: The number of patients needed to receive a booster dose was highly dependent on local disease incidence, outcome severity, and patient risk factors for moderate-to-severe disease. Funding: Funding was provided by the Centers for Disease Control and Prevention though contract 75D30120C07986 to Westat, Inc. and contract 75D30120C07765 to Kaiser Foundation Hospitals.

Estimated Effectiveness of JYNNEOS Vaccine in Preventing Mpox: A Multijurisdictional Case-Control Study - United States, August 19, 2022-March 31, 2023.

As of March 31, 2023, more than 30,000 monkeypox (mpox) cases had been reported in the United States in an outbreak that has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) and transgender persons (1). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic) was approved by the Food and Drug Administration (FDA) in 2019 for the prevention of smallpox and mpox via subcutaneous injection as a 2-dose series (0.5 mL per dose, administered 4 weeks apart) (2). To expand vaccine access, an Emergency Use Authorization was issued by FDA on August 9, 2022, for dose-sparing intradermal injection of JYNNEOS as a 2-dose series (0.1 mL per dose, administered 4 weeks apart) (3). Vaccination was available to persons with known or presumed exposure to a person with mpox (postexposure prophylaxis [PEP]), as well as persons at increased risk for mpox or who might benefit from vaccination (preexposure mpox prophylaxis [PrEP]) (4). Because information on JYNNEOS vaccine effectiveness (VE) is limited, a matched case-control study was conducted in 12 U.S. jurisdictions,† including nine Emerging Infections Program sites and three Epidemiology and Laboratory Capacity sites,§ to evaluate VE against mpox among MSM and transgender adults aged 18-49 years. During August 19, 2022-March 31, 2023, a total of 309 case-patients were matched to 608 control patients. Adjusted VE was 75.2% (95% CI = 61.2% to 84.2%) for partial vaccination (1 dose) and 85.9% (95% CI = 73.8% to 92.4%) for full vaccination (2 doses). Adjusted VE for full vaccination by subcutaneous, intradermal, and heterologous routes of administration was 88.9% (95% CI = 56.0% to 97.2%), 80.3% (95% CI = 22.9% to 95.0%), and 86.9% (95% CI = 69.1% to 94.5%), respectively. Adjusted VE for full vaccination among immunocompromised participants was 70.2% (95% CI = -37.9% to 93.6%) and among immunocompetent participants was 87.8% (95% CI = 57.5% to 96.5%). JYNNEOS is effective at reducing the risk for mpox. Because duration of protection of 1 versus 2 doses remains unknown, persons at increased risk for mpox exposure should receive the 2-dose series as recommended by the Advisory Committee on Immunization Practices (ACIP),¶ regardless of administration route or immunocompromise status.

Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States.

BACKGROUND: In the United States, more than 30,000 cases of mpox (formerly known as monkeypox) had occurred as of March 1, 2023, in an outbreak disproportionately affecting transgender persons and gay, bisexual, and other men who have sex with men. In 2019, the JYNNEOS vaccine was approved for subcutaneous administration (0.5 ml per dose) to prevent mpox infection. On August 9, 2022, an emergency use authorization was issued for intradermal administration (0.1 ml per dose); however, real-world effectiveness data are limited for either route. METHODS: We conducted a case-control study based on data from Cosmos, a nationwide Epic electronic health record (EHR) database, to assess the effectiveness of JYNNEOS vaccination in preventing medically attended mpox disease among adults. Case patients had an mpox diagnosis code or positive orthopoxvirus or mpox virus laboratory result, and control patients had an incident diagnosis of human immunodeficiency virus (HIV) infection or a new or refill order for preexposure prophylaxis against HIV infection between August 15, 2022, and November 19, 2022. Odds ratios and 95% confidence intervals were estimated from conditional logistic-regression models, adjusted for confounders; vaccine effectiveness was calculated as (1 - odds ratio for vaccination in case patients vs. controls) × 100. RESULTS: Among 2193 case patients and 8319 control patients, 25 case patients and 335 control patients received two doses (full vaccination), among whom the estimated adjusted vaccine effectiveness was 66.0% (95% confidence interval [CI], 47.4 to 78.1), and 146 case patients and 1000 control patients received one dose (partial vaccination), among whom the estimated adjusted vaccine effectiveness was 35.8% (95% CI, 22.1 to 47.1). CONCLUSIONS: In this study using nationwide EHR data, patients with mpox were less likely to have received one or two doses of JYNNEOS vaccine than control patients. The findings suggest that JYNNEOS vaccine was effective in preventing mpox disease, and a two-dose series appeared to provide better protection. (Funded by the Centers for Disease Control and Prevention and Epic Research.).

Effectiveness of BNT162b2 COVID-19 Vaccination in Children and Adolescents.

OBJECTIVES: We assessed BNT162b2 vaccine effectiveness (VE) against mild to moderate and severe coronavirus disease 2019 (COVID-19) in children and adolescents through the Omicron BA.4/BA.5 period. METHODS: Using VISION Network records from April 2021 to September 2022, we conducted a test-negative, case-control study assessing VE against COVID-19-associated emergency department/urgent care (ED/UC) encounters and hospitalizations using logistic regression, conditioned on month and site, adjusted for covariates. RESULTS: We compared 9800 ED/UC cases with 70 232 controls, and 305 hospitalized cases with 2612 controls. During Delta, 2-dose VE against ED/UC encounters at 12 to 15 years was initially 93% (95% confidence interval 89 to 95), waning to 77% (69% to 84%) after ≥150 days. At ages 16 to 17, VE was initially 93% (86% to 97%), waning to 72% (63% to 79%) after ≥150 days. During Omicron, VE at ages 12 to 15 was initially 64% (44% to 77%), waning to 13% (3% to 23%) after ≥150 days; at ages 16 to 17 VE was 31% (10% to 47%) during days 60 to 149, waning to 7% (-8 to 20%) after 150 days. A monovalent booster increased VE to 54% (40% to 65%) at ages 12 to 15 and 46% (30% to 58%) at ages 16 to 17. At ages 5 to 11, 2-dose VE was 49% (33% to 61%) initially and 41% (29% to 51%) after 150 days. During Delta, VE against hospitalizations at ages 12 to 17 was high (>97%), and at ages 16 to 17 remained 98% (73% to 100%) beyond 150 days; during Omicron, hospitalizations were too infrequent to precisely estimate VE. CONCLUSIONS: BNT162b2 protected children and adolescents against mild to moderate and severe COVID-19. VE was lower during Omicron predominance including BA.4/BA.5, waned after dose 2 but increased after a monovalent booster. Children and adolescents should receive all recommended COVID-19 vaccinations.

Patient and Epidemiological Factors Associated With Influenza Testing in Hospitalized Adults With Acute Respiratory Illnesses, 2016-2017 to 2019-2020.

Background: Data are limited on influenza testing among adults with acute respiratory illness (ARI)-associated hospitalizations. We identified factors associated with influenza testing in adult ARI-associated hospitalizations across the 2016-2017 through 2019-2020 influenza seasons. Methods: Using data from 4 health systems in the United States, we identified hospitalizations that had an ARI discharge diagnosis or respiratory virus test. A hospitalization with influenza testing was based on testing performed within 14 days before through 72 hours after admission. We used random forest analysis to identify patient characteristics and influenza activity indicators that were most important in terms of their relationship to influenza testing. Results: Across 4 seasons, testing rates ranged from 14.8%-19.4% at 3 pooled sites and 60.1%-78.5% at a fourth site with different testing practices. Discharge diagnoses of pneumonia or infectious disease of noninfluenza etiology, presence of ARI signs/symptoms, hospital admission month, and influenza-like illness activity level were consistently among the variables with the greatest relative importance. Conclusions: Select ARI diagnoses and indicators of influenza activity were the most important factors associated with influenza testing among ARI-associated hospitalizations. Improved understanding of which patients are tested may enhance influenza burden estimates and allow for more timely clinical management of influenza-associated hospitalizations.

Vaccine Effectiveness Against Influenza-Associated Urgent Care, Emergency Department, and Hospital Encounters During the 2021-2022 Season, VISION Network.

BACKGROUND: Following historically low influenza activity during the 2020-2021 season, the United States saw an increase in influenza circulating during the 2021-2022 season. Most viruses belonged to the influenza A(H3N2) 3C.2a1b 2a.2 subclade. METHODS: We conducted a test-negative case-control analysis among adults ≥18 years of age at 3 sites within the VISION Network. Encounters included emergency department/urgent care (ED/UC) visits or hospitalizations with ≥1 acute respiratory illness (ARI) discharge diagnosis codes and molecular testing for influenza. Vaccine effectiveness (VE) was calculated by comparing the odds of influenza vaccination ≥14 days before the encounter date between influenza-positive cases (type A) and influenza-negative and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-negative controls, applying inverse probability-to-be-vaccinated weights, and adjusting for confounders. RESULTS: In total, 86 732 ED/UC ARI-associated encounters (7696 [9%] cases) and 16 805 hospitalized ARI-associated encounters (649 [4%] cases) were included. VE against influenza-associated ED/UC encounters was 25% (95% confidence interval (CI), 20%-29%) and 25% (95% CI, 11%-37%) against influenza-associated hospitalizations. VE against ED/UC encounters was lower in adults ≥65 years of age (7%; 95% CI, -5% to 17%) or with immunocompromising conditions (4%; 95% CI, -45% to 36%). CONCLUSIONS: During an influenza A(H3N2)-predominant influenza season, modest VE was observed. These findings highlight the need for improved vaccines, particularly for A(H3N2) viruses that are historically associated with lower VE.

Relationships Between Social Vulnerability and Coronavirus Disease 2019 Vaccination Coverage and Vaccine Effectiveness.

BACKGROUND: Coronavirus disease 2019 (COVID-19) vaccination coverage remains lower in communities with higher social vulnerability. Factors such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure risk and access to healthcare are often correlated with social vulnerability and may therefore contribute to a relationship between vulnerability and observed vaccine effectiveness (VE). Understanding whether these factors impact VE could contribute to our understanding of real-world VE. METHODS: We used electronic health record data from 7 health systems to assess vaccination coverage among patients with medically attended COVID-19-like illness. We then used a test-negative design to assess VE for 2- and 3-dose messenger RNA (mRNA) adult (≥18 years) vaccine recipients across Social Vulnerability Index (SVI) quartiles. SVI rankings were determined by geocoding patient addresses to census tracts; rankings were grouped into quartiles for analysis. RESULTS: In July 2021, primary series vaccination coverage was higher in the least vulnerable quartile than in the most vulnerable quartile (56% vs 36%, respectively). In February 2022, booster dose coverage among persons who had completed a primary series was higher in the least vulnerable quartile than in the most vulnerable quartile (43% vs 30%). VE among 2-dose and 3-dose recipients during the Delta and Omicron BA.1 periods of predominance was similar across SVI quartiles. CONCLUSIONS: COVID-19 vaccination coverage varied substantially by SVI. Differences in VE estimates by SVI were minimal across groups after adjusting for baseline patient factors. However, lower vaccination coverage among more socially vulnerable groups means that the burden of illness is still disproportionately borne by the most socially vulnerable populations.

Effect of a Patient Decision Aid on Preferences for Colorectal Cancer Screening Among Older Adults: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Guidelines recommend individualized decision-making for colorectal cancer (CRC) screening among adults aged 76 to 84 years, a process that includes a consideration of health state and patient preference. Objective: To determine whether a targeted patient decision aid would align older adults' screening preference with their potential to benefit from CRC screening. Design, Setting, and Participants: This is a prespecified secondary analysis from a randomized clinical trial. Participants aged 70 to 84 years who were not up to date with screening and had an appointment within 6 weeks were purposively sampled by health state (poor, intermediate, or good) at 14 community-based primary care practices and block randomized to receive the intervention or control. Patients were recruited from March 1, 2012, to February 28, 2015, and these secondary analyses were performed from January 15 to March 1, 2022. Interventions: Patient decision aid targeted to age and sex. Main Outcomes and Measures: The primary outcome of this analysis was patient preference for CRC screening. The a priori hypothesis was that the decision aid (intervention) group would reduce the proportion preferring screening among those in poor and intermediate health compared with the control group. Results: Among the 424 participants, the mean (SD) age was 76.8 (4.2) years; 248 (58.5%) of participants were women; and 333 (78.5%) were White. The proportion preferring screening in the intervention group was less than in the control group for those in the intermediate health state (34 of 76 [44.7%] vs 40 of 73 [54.8%]; absolute difference, -10.1% [95% CI, -26.0% to 5.9%]) and in the poor health state (24 of 62 [38.7%] vs 33 of 61 [54.1%]; absolute difference, -15.4% [95% CI, -32.8% to 2.0%]). These differences were not statistically significant. The proportion of those in good health who preferred screening was similar between the intervention and control groups (44 of 74 [59.5%] for intervention vs 46 of 75 [61.3%] for control; absolute difference, -1.9% [95% CI, -17.6% to 13.8%]). Conclusions and Relevance: The findings of this secondary analysis of a clinical trial did not demonstrate statistically significant differences in patient preferences between the health groups. Additional studies that are appropriately powered are needed to determine the effect of the decision aid on the preferences of older patients for CRC screening by health state. Trial Registration: ClinicalTrials.gov Identifier: NCT01575990.

Effectiveness of Homologous and Heterologous COVID-19 Booster Doses Following 1 Ad.26.COV2.S (Janssen [Johnson & Johnson]) Vaccine Dose Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults - VISION Network, 10 States, December 2021-March 2022.

CDC recommends that all persons aged ≥18 years receive a single COVID-19 vaccine booster dose ≥2 months after receipt of an Ad.26.COV2.S (Janssen [Johnson & Johnson]) adenovirus vector-based primary series vaccine; a heterologous COVID-19 mRNA vaccine is preferred over a homologous (matching) Janssen vaccine for booster vaccination. This recommendation was made in light of the risks for rare but serious adverse events following receipt of a Janssen vaccine, including thrombosis with thrombocytopenia syndrome and Guillain-Barré syndrome† (1), and clinical trial data indicating similar or higher neutralizing antibody response following heterologous boosting compared with homologous boosting (2). Data on real-world vaccine effectiveness (VE) of different booster strategies following a primary Janssen vaccine dose are limited, particularly during the period of Omicron variant predominance. The VISION Network§ determined real-world VE of 1 Janssen vaccine dose and 2 alternative booster dose strategies: 1) a homologous booster (i.e., 2 Janssen doses) and 2) a heterologous mRNA booster (i.e., 1 Janssen dose/1 mRNA dose). In addition, VE of these booster strategies was compared with VE of a homologous booster following mRNA primary series vaccination (i.e., 3 mRNA doses). The study examined 80,287 emergency department/urgent care (ED/UC) visits¶ and 25,244 hospitalizations across 10 states during December 16, 2021-March 7, 2022, when Omicron was the predominant circulating variant.** VE against laboratory-confirmed COVID-19-associated ED/UC encounters was 24% after 1 Janssen dose, 54% after 2 Janssen doses, 79% after 1 Janssen/1 mRNA dose, and 83% after 3 mRNA doses. VE for the same vaccination strategies against laboratory-confirmed COVID-19-associated hospitalizations were 31%, 67%, 78%, and 90%, respectively. All booster strategies provided higher protection than a single Janssen dose against ED/UC visits and hospitalizations during Omicron variant predominance. Vaccination with 1 Janssen/1 mRNA dose provided higher protection than did 2 Janssen doses against COVID-19-associated ED/UC visits and was comparable to protection provided by 3 mRNA doses during the first 120 days after a booster dose. However, 3 mRNA doses provided higher protection against COVID-19-associated hospitalizations than did other booster strategies during the same time interval since booster dose. All adults who have received mRNA vaccines for their COVID-19 primary series vaccination should receive an mRNA booster dose when eligible. Adults who received a primary Janssen vaccine dose should preferentially receive a heterologous mRNA vaccine booster dose ≥2 months later, or a homologous Janssen vaccine booster dose if mRNA vaccine is contraindicated or unavailable. Further investigation of the durability of protection afforded by different booster strategies is warranted.

Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5-17 Years - VISION Network, 10 States, April 2021-January 2022.

The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, and 16-17 years (1-3). Limited real-world data on 2-dose mRNA vaccine effectiveness (VE) in persons aged 12-17 years (referred to as adolescents in this report) have also indicated high levels of protection against SARS-CoV-2 (the virus that causes COVID-19) infection and COVID-19-associated hospitalization (4-6); however, data on VE against the SARS-CoV-2 B.1.1.529 (Omicron) variant and duration of protection are limited. Pfizer-BioNTech VE data are not available for children aged 5-11 years. In partnership with CDC, the VISION Network* examined 39,217 emergency department (ED) and urgent care (UC) encounters and 1,699 hospitalizations† among persons aged 5-17 years with COVID-19-like illness across 10 states during April 9, 2021-January 29, 2022,§ to estimate VE using a case-control test-negative design. Among children aged 5-11 years, VE against laboratory-confirmed COVID-19-associated ED and UC encounters 14-67 days after dose 2 (the longest interval after dose 2 in this age group) was 46%. Among adolescents aged 12-15 and 16-17 years, VE 14-149 days after dose 2 was 83% and 76%, respectively; VE ≥150 days after dose 2 was 38% and 46%, respectively. Among adolescents aged 16-17 years, VE increased to 86% ≥7 days after dose 3 (booster dose). VE against COVID-19-associated ED and UC encounters was substantially lower during the Omicron predominant period than the B.1.617.2 (Delta) predominant period among adolescents aged 12-17 years, with no significant protection ≥150 days after dose 2 during Omicron predominance. However, in adolescents aged 16-17 years, VE during the Omicron predominant period increased to 81% ≥7 days after a third booster dose. During the full study period, including pre-Delta, Delta, and Omicron predominant periods, VE against laboratory-confirmed COVID-19-associated hospitalization among children aged 5-11 years was 74% 14-67 days after dose 2, with wide CIs that included zero. Among adolescents aged 12-15 and 16-17 years, VE 14-149 days after dose 2 was 92% and 94%, respectively; VE ≥150 days after dose 2 was 73% and 88%, respectively. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations, including a booster dose for those aged 12-17 years.

Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance - VISION Network, 10 States, August 2021-January 2022.

CDC recommends that all persons aged ≥12 years receive a booster dose of COVID-19 mRNA vaccine ≥5 months after completion of a primary mRNA vaccination series and that immunocompromised persons receive a third primary dose.* Waning of vaccine protection after 2 doses of mRNA vaccine has been observed during the period of the SARS-CoV-2 B.1.617.2 (Delta) variant predominance† (1-5), but little is known about durability of protection after 3 doses during periods of Delta or SARS-CoV-2 B.1.1.529 (Omicron) variant predominance. A test-negative case-control study design using data from eight VISION Network sites§ examined vaccine effectiveness (VE) against COVID-19 emergency department/urgent care (ED/UC) visits and hospitalizations among U.S. adults aged ≥18 years at various time points after receipt of a second or third vaccine dose during two periods: Delta variant predominance and Omicron variant predominance (i.e., periods when each variant accounted for ≥50% of sequenced isolates).¶ Persons categorized as having received 3 doses included those who received a third dose in a primary series or a booster dose after a 2 dose primary series (including the reduced-dosage Moderna booster). The VISION Network analyzed 241,204 ED/UC encounters** and 93,408 hospitalizations across 10 states during August 26, 2021-January 22, 2022. VE after receipt of both 2 and 3 doses was lower during the Omicron-predominant than during the Delta-predominant period at all time points evaluated. During both periods, VE after receipt of a third dose was higher than that after a second dose; however, VE waned with increasing time since vaccination. During the Omicron period, VE against ED/UC visits was 87% during the first 2 months after a third dose and decreased to 66% among those vaccinated 4-5 months earlier; VE against hospitalizations was 91% during the first 2 months following a third dose and decreased to 78% ≥4 months after a third dose. For both Delta- and Omicron-predominant periods, VE was generally higher for protection against hospitalizations than against ED/UC visits. All eligible persons should remain up to date with recommended COVID-19 vaccinations to best protect against COVID-19-associated hospitalizations and ED/UC visits.

Development and validation of a 5-year mortality prediction model using regularized regression and Medicare data.

PURPOSE: De-implementation of low-value services among patients with limited life expectancy is challenging. Robust mortality prediction models using routinely collected health care data can enhance health care stakeholders' ability to identify populations with limited life expectancy. We developed and validated a claims-based prediction model for 5-year mortality using regularized regression methods. METHODS: Medicare beneficiaries age 66 or older with an office visit and at least 12 months of pre-visit continuous Medicare A/B enrollment were identified in 2008. Five-year mortality was assessed through 2013. Secondary outcomes included 30-, 90-, and 180-day and 1-year mortality. Claims-based predictors, including comorbidities and indicators of disability, frailty, and functional impairment, were selected using regularized logistic regression, applying the least absolute shrinkage and selection operator (LASSO) in a random 80% training sample. Model performance was assessed and compared with the Gagne comorbidity score in the 20% validation sample. RESULTS: Overall, 183 204 (24%) individuals died. In addition to demographics, 161 indicators of comorbidity and function were included in the final model. In the validation sample, the c-statistic was 0.825 (0.823-0.828). Median-predicted probability of 5-year mortality was 14%; almost 4% of the cohort had a predicted probability greater than 80%. Compared with the Gagne score, the LASSO model led to improved 5-year mortality classification (net reclassification index = 9.9%; integrated discrimination index = 5.2%). CONCLUSIONS: Our claims-based model predicting 5-year mortality showed excellent discrimination and calibration, similar to the Gagne score model, but resulted in improved mortality classification. Regularized regression is a feasible approach for developing prediction tools that could enhance health care research and evaluation of care quality.

Individualized Colorectal Cancer Screening Discussions Between Older Adults and Their Primary Care Providers: A Cross-Sectional Study.

Introduction. Discussions of colorectal cancer (CRC) screening with older adults should be individualized to maximize appropriate screening. Our aim was to describe CRC screening discussions and explore their associations with patient characteristics and screening intentions. Methods. Cross-sectional survey of 422 primary care patients aged ≥70 years and eligible for CRC screening, including open-ended questions about CRC screening discussions. Primary outcomes were the frequency with which CRC screening discussions occurred, who had those discussions, and the domains that emerged from thematic analysis of participants' brief reports of their discussions. We also examined the associations between 1) patient characteristics and whether a screening discussion occurred and 2) the domains discussed and what screening decisions were made. Results. Of 422 participants, 209 reported having discussions and 201 responded to open-ended questions about CRC discussions. In a regression analysis, several factors were associated with increased odds of having a discussion: participants' preference to pursue screening (odds ratio [OR] 2.3, 95% confidence interval [CI] 1.3, 3.9), good health (OR 2.9, 95% CI 1.7, 4.8), and receipt of the decision aid (OR 2.1, 95% CI 1.4, 3.2). Our thematic analysis identified five domains related to discussion content and three related to discussion process. The CRC screening-related information domain was the most commonly discussed content domain, and the timing/frequency domain was associated with increased odds of intent to pursue screening. Decision-making role, the most commonly discussed process domain, was associated with increased odds of the intent to forgo CRC screening. Conclusions and Relevance. CRC screening discussions varied by type of participant and content. Future work is needed to determine if interventions focused on specific domains alters the appropriateness of participants' colorectal cancer screening intentions.

Developing a Quality Measurement Strategy in an Academic Primary Care Setting: An Environmental Scan.

PURPOSE: The purpose of this project was to: (1) develop a strategy for primary care quality measurement using an environmental scan and interviews to identify best practices and candidate measures; (2) present recommendations to facilitate successful measurement. METHODS: Following stakeholder interviews and review of existing measures, we created a three-tiered recommendation system for selecting and implementing measures. We also developed a framework for reviewing and prioritizing measures and prepared a detailed project report. RESULTS: Interviews provided a broader perspective on measuring quality, including implementing measures, measuring value, and identifying measurement gaps. Our recommendations fall into three tiers: Tier 1 measures can be implemented quickly and include clinical processes and outcomes for preventive care and disease states. Tier 2 measures require modifications to electronic health record, workflows, and/or staff preparation. Tier 3 (Strategic Vision) addresses topics that should be incorporated in the future to ensure high-quality primary care (adherence, patient activation, patient experience, teamness, staff satisfaction, and value), and infrastructure development to support ongoing quality measurement. CONCLUSIONS: Implementing a quality measurement strategy is challenging and labor-intensive but is necessary to improve healthcare quality. Our work demonstrates the effort and investment required to progress quality measurement and offers recommendations for successfully undertaking this type of endeavor.

A Decision Aid to Promote Appropriate Colorectal Cancer Screening among Older Adults: A Randomized Controlled Trial.

BACKGROUND: Concerns have been raised about both over- and underutilization of colorectal cancer (CRC) screening in older patients and the need to align screening behavior with likelihood of net benefit. OBJECTIVE: The purpose of this study was to test a novel use of a patient decision aid (PtDA) to promote appropriate CRC screening in older adults. METHODS: A total of 424 patients ages 70 to 84 y who were not up to date with CRC screening participated in a double-blinded randomized controlled trial of a PtDA targeted to older adults making decisions about whether to undergo CRC screening from March 2012 to February 2015. INTERVENTION: Patients were randomized to a targeted PtDA or an attention control. The PtDA was designed to facilitate individualized decision making-helping patients understand the potential risks, benefits, and uncertainties of CRC screening given advanced age, health state, preferences, and values. OUTCOMES: Two composite outcomes, appropriate CRC screening behavior 6 mo after the index visit and appropriate screening intent immediately after the visit, were defined as completed screening or intent for patients in good health, discussion about screening with their provider for patients in intermediate health, and no screening or intent for patients in poor health. Health state was determined by age and Charlson Comorbidity Index. RESULTS: Four hundred twelve (97%) and 421 (99%) patients were analyzed for the primary and secondary outcomes, respectively. Appropriate screening behavior at 6 mo was higher in the intervention group (55% v. 45%, P = 0.023) as was appropriate screening intent following the provider visit (61% v. 47%, P = 0.003). LIMITATIONS: The study took place in a single geographic region. The appropriate CRC screening classification system used in this study has not been formally validated. CONCLUSIONS: A PtDA for older adults promoted appropriate CRC screening behavior and intent. TRIAL REGISTRATION: Clinicaltrials.gov, registration number NCT01575990. https://clinicaltrials.gov/ct2/show/NCT01575990?term=epic-d&rank=1.

Implementation and Evaluation of a Novel Colorectal Cancer Decision Aid Using a Centralized Delivery Strategy.

BACKGROUND: Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States; however, CRC screening reduces both incidence and mortality rates. Patient decision aids (DAs) are an evidence-based strategy to support patients making health-related decisions. CRC screening DAs can be unsuccessful due to provider preferences for colonoscopy and lack of effective DA implementation strategies within clinical settings. METHODS: A hybrid implementation-effectiveness study was conducted testing the feasibility of using an existing centralized preventive health screening outreach infrastructure to implement a novel CRC DA across a health care system. Participants included primary care patients at one of three study clinics. Implementation was assessed by determining whether patients remembered receiving the DA and were aware of CRC screening options. Effectiveness was measured by comparing overall screening rates between the control and intervention groups. RESULTS: Using a centralized delivery system was a feasible and efficient method for implementing DAs to a large academic health system. More than 90% of the intervention group remembered receiving the DA, and 80% found it helpful in their decision-making process. The DA was successful in improving CRC screening knowledge; however, overall CRC screening rates significantly decreased between the control and intervention periods (50.8% vs. 39.2%, respectively; p = 0.03). CONCLUSION: Centralized delivery is a feasible method for DA implementation. Although DAs increase knowledge, the true effectiveness of CRC DAs in clinical settings is unknown, as a result of the number in screening tests, diversity in DA format, and the variability in dissemination and implementation practices.

Design of a randomized clinical trial of a colorectal cancer screening decision aid to promote appropriate screening in community-dwelling older adults.

BACKGROUND: Appropriate colorectal cancer screening in older adults should be aligned with the likelihood of net benefit. In general, patient decision aids improve knowledge and values clarity, but in older adults, they may also help patients identify their individual likelihood of benefit and foster individualized decision-making. We report on the design of a randomized clinical trial to understand the effects of a patient decision aid on appropriate colorectal cancer screening. This report includes a description of the baseline characteristics of participants. METHODS: English-speaking primary care patients aged 70-84 years who were not currently up to date with screening were recruited into a randomized clinical trial comparing a tailored colorectal cancer screening decision aid with an attention control. The intervention group received a decision aid that included a values clarification exercise and individualized decision-making worksheet, while the control group received an educational pamphlet on safe driving behaviors. The primary outcome was appropriate screening at 6 months based on chart review. We used a composite measure to define appropriate screening as screening for participants in good health, a discussion about screening for patients in intermediate health, and no screening for patients in poor health. Health state was objectively determined using patients' Charlson Comorbidity Index score and age. RESULTS: A total of 14 practices in central North Carolina participated as part of a practice-based research network. In total, 424 patients were recruited to participate and completed a baseline visit. Overall, 79% of participants were White and 58% female, with a mean age of 76.8 years. Patient characteristics between groups were similar by age, gender, race, education, insurance coverage, or work status. Overall, 70% had some college education or more, 57% were married, and virtually all had Medicare insurance (90%). The three primary medical conditions among the cohort were a history of diabetes, pneumonia, and cancer (28%, 26%, and 21%, respectively). CONCLUSION: We designed a randomized clinical trial to test a novel use of a patient decision aid to promote appropriate colorectal cancer screening and have recruited a diverse study population that seems similar between the intervention and control groups. The study should be able to determine the ability of a patient decision aid to increase individualized and appropriate colorectal cancer screening.

Developing and Evaluating a Clinic-Based Decision Aid Delivery System.

Background: Despite evidence of their benefits, decision aids (DAs) have not been widely adopted in clinical practice. Quality improvement methods could help embed DA delivery into primary care workflows and facilitate DA delivery and uptake, defined as reading or watching DA materials. Objectives: 1) Work with clinic staff and providers to develop and test multiple processes for DA delivery; 2) implement a systems approach to measuring delivery and uptake; 3) compare uptake and patient satisfaction across delivery models. Methods: We employed a microsystems approach to implement three DA delivery models into primary care processes and workflows: within existing disease management programs, by physician request, and by mail. We developed a database and tracking tools linked to our electronic health record and designed clinic-based processes to measure uptake and satisfaction. Results: A total of 1144 DAs were delivered. Depending on delivery method, 51% to 73% of patients returned to the clinic within 6 months. Nurses asked 67% to 75% of this group follow-up questions, and 65% to 79% recalled receiving the DA. Among them, uptake was 23% to 27%. Satisfaction among patients who recalled receiving the DA was high. Eighty-two to 93% of patients reported that they liked receiving this patient education information, and 82% to 91% reported that receiving patient education information like this is useful to them. Conclusion: Our results demonstrate the realities of clinical practice. One fourth to one third of patients did not return for a follow-up visit. Although nurses were able to assess uptake in the course of their usual duties, the results did not achieve the standards typically expected of clinical research. Despite these limitations, uptake, though modest, was similar across delivery methods, suggesting that there are multiple strategies for implementing DAs in clinical practice.

Relationship between Physicians' Uncertainty about Clinical Assessments and Patient-Centered Recommendations for Colorectal Cancer Screening in the Elderly.

OBJECTIVE: The goal of this study was to examine associations between physicians' clinical assessments, their certainty in these assessments, and the likelihood of a patient-centered recommendation about colorectal cancer (CRC) screening in the elderly. METHODS: Two hundred seventy-six primary care physicians in the United States read 3 vignettes about an 80-year-old female patient and answered questions about her life expectancy, their confidence in their life expectancy estimate, the balance of benefits/downsides of CRC screening, their certainty in their benefit/downside assessment, and the best course of action regarding CRC screening. We used logistic regression to determine the relationship between these variables and patient-centered recommendations about CRC screening. RESULTS: In bivariate analyses, physicians had higher odds of making a patient-centered recommendation about CRC screening when their clinical assessments did not lead to a clear screening recommendation or when they experienced uncertainty in their clinical assessments. However, in a multivariate regression model, only benefit/downside assessment and best course of action remained statistically significant predictors of a patient-centered recommendation. CONCLUSIONS: Our findings demonstrate that when the results of clinical assessments do not lead to obvious screening decisions or when physicians feel uncertain about their clinical assessments, they are more likely to make patient-centered recommendations. Existing uncertainty frameworks do not adequately describe the uncertainty associated with patient-centered recommendations found in this study. Adapting or modifying these frameworks to better reflect the constructs associated with uncertainty and the interactions between uncertainty and the complexity inherent in clinical decisions will facilitate a more complete understanding of how and when physicians choose to include patients in clinical decisions.