Design and rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension.

RATIONALE AND OBJECTIVE: APOL1 risk alleles are associated with increased cardiovascular and chronic kidney disease (CKD) risk. It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) targets to reduce cardiovascular disease. STUDY DESIGN: Multicenter, pragmatic, randomized controlled clinical trial. SETTING AND PARTICIPANTS: 6650 individuals with African ancestry and hypertension from 13 health systems. INTERVENTION: APOL1 genotyping with clinical decision support (CDS) results are returned to participants and providers immediately (intervention) or at 6 months (control). A subset of participants are re-randomized to pharmacogenomic testing for relevant antihypertensive medications (pharmacogenomic sub-study). CDS alerts encourage appropriate CKD screening and antihypertensive agent use. OUTCOMES: Blood pressure and surveys are assessed at baseline, 3 and 6 months. The primary outcome is change in systolic BP from enrollment to 3 months in individuals with two APOL1 risk alleles. Secondary outcomes include new diagnoses of CKD, systolic blood pressure at 6 months, diastolic BP, and survey results. The pharmacogenomic sub-study will evaluate the relationship of pharmacogenomic genotype and change in systolic BP between baseline and 3 months. RESULTS: To date, the trial has enrolled 3423 participants. CONCLUSIONS: The effect of patient and provider knowledge of APOL1 genotype on systolic blood pressure has not been well-studied. GUARDD-US addresses whether blood pressure improves when patients and providers have this information. GUARDD-US provides a CDS framework for primary care and specialty clinics to incorporate APOL1 genetic risk and pharmacogenomic prescribing in the electronic health record. TRIAL REGISTRATION: ClinicalTrials.govNCT04191824.

Effects of Testing and Disclosing Ancestry-Specific Genetic Risk for Kidney Failure on Patients and Health Care Professionals: A Randomized Clinical Trial.

IMPORTANCE: Risk variants in the apolipoprotein L1 (APOL1 [OMIM 603743]) gene on chromosome 22 are common in individuals of West African ancestry and confer increased risk of kidney failure for people with African ancestry and hypertension. Whether disclosing APOL1 genetic testing results to patients of African ancestry and their clinicians affects blood pressure, kidney disease screening, or patient behaviors is unknown. OBJECTIVE: To determine the effects of testing and disclosing APOL1 genetic results to patients of African ancestry with hypertension and their clinicians. DESIGN, SETTING, AND PARTICIPANTS: This pragmatic randomized clinical trial randomly assigned 2050 adults of African ancestry with hypertension and without existing chronic kidney disease in 2 US health care systems from November 1, 2014, through November 28, 2016; the final date of follow-up was January 16, 2018. Patients were randomly assigned to undergo immediate (intervention) or delayed (waiting list control group) APOL1 testing in a 7:1 ratio. Statistical analysis was performed from May 1, 2018, to July 31, 2020. INTERVENTIONS: Patients randomly assigned to the intervention group received APOL1 genetic testing results from trained staff; their clinicians received results through clinical decision support in electronic health records. Waiting list control patients received the results after their 12-month follow-up visit. MAIN OUTCOMES AND MEASURES: Coprimary outcomes were the change in 3-month systolic blood pressure and 12-month urine kidney disease screening comparing intervention patients with high-risk APOL1 genotypes and those with low-risk APOL1 genotypes. Secondary outcomes compared these outcomes between intervention group patients with high-risk APOL1 genotypes and controls. Exploratory analyses included psychobehavioral factors. RESULTS: Among 2050 randomly assigned patients (1360 women [66%]; mean [SD] age, 53 [10] years), the baseline mean (SD) systolic blood pressure was significantly higher in patients with high-risk APOL1 genotypes vs those with low-risk APOL1 genotypes and controls (137 [21] vs 134 [19] vs 133 [19] mm Hg; P = .003 for high-risk vs low-risk APOL1 genotypes; P = .001 for high-risk APOL1 genotypes vs controls). At 3 months, the mean (SD) change in systolic blood pressure was significantly greater in patients with high-risk APOL1 genotypes vs those with low-risk APOL1 genotypes (6 [18] vs 3 [18] mm Hg; P = .004) and controls (6 [18] vs 3 [19] mm Hg; P = .01). At 12 months, there was a 12% increase in urine kidney disease testing among patients with high-risk APOL1 genotypes (from 39 of 234 [17%] to 68 of 234 [29%]) vs a 6% increase among those with low-risk APOL1 genotypes (from 278 of 1561 [18%] to 377 of 1561 [24%]; P = .10) and a 7% increase among controls (from 33 of 255 [13%] to 50 of 255 [20%]; P = .01). In response to testing, patients with high-risk APOL1 genotypes reported more changes in lifestyle (a subjective measure that included better dietary and exercise habits; 129 of 218 [59%] vs 547 of 1468 [37%]; P < .001) and increased blood pressure medication use (21 of 218 [10%] vs 68 of 1468 [5%]; P = .005) vs those with low-risk APOL1 genotypes; 1631 of 1686 (97%) declared they would get tested again. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, disclosing APOL1 genetic testing results to patients of African ancestry with hypertension and their clinicians was associated with a greater reduction in systolic blood pressure, increased kidney disease screening, and positive self-reported behavior changes in those with high-risk genotypes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02234063.

Correction to: Effects of workload, work complexity, and repeated alerts on alert fatigue in a clinical decision support system.

Following publication of the original article [1], the authors reported that the article erroneously stated that Dr. Ancker was affiliated with the Tehran University of Medical Sciences. Dr. Ancker is not affiliated with that institution.

Effect of a Self-management Support Intervention on Asthma Outcomes in Older Adults: The SAMBA Study Randomized Clinical Trial.

IMPORTANCE: Older adults with asthma have worse control and outcomes than younger adults. Interventions to address suboptimal self-management among older adults with asthma are typically not tailored to the specific needs of the patient. OBJECTIVE: To test the effect of a comprehensive, patient-tailored asthma self-management support intervention for older adults on clinical and self-management outcomes. DESIGN, SETTING, AND PARTICIPANTS: Three-arm randomized clinical trial conducted between February 2014 and December 2017 at primary care practices and personal residences in New York City. Adults 60 years and older with persistent, uncontrolled asthma were identified from electronic medical records at an academic medical center and a federally qualified health center. Of 1349 patients assessed for eligibility, 406 met eligibility criteria, consented to participate, and were randomized to 1 of 3 groups: home-based intervention, clinic-based intervention, or control (usual care). A total of 391 patients received the allocated treatment. INTERVENTIONS: Screening for psychosocial, physical, cognitive, and environmental barriers to asthma control and self-management with actions to address identified barriers. The intervention was delivered in the home or primary care practices by asthma care coaches. MAIN OUTCOMES AND MEASURES: Primary outcomes were the Asthma Control Test, Mini Asthma Quality of Life Questionnaire, Medication Adherence Rating Scale, metered dose inhaler technique, and emergency department visits for asthma care. Primary analyses compared intervention (home or clinic based) with usual care. RESULTS: Of the 391 patients who received treatment, 58 (15.1%) were men, and the mean (SD) age was 67.8 (7.4) years. After accounting for baseline scores, scores on the asthma control test were better in the intervention groups vs the control group (difference-in-differences at 3 months, 1.2; 95% CI, 0.2-2.2; P = .02; 6 months, 1.0; 95% CI, 0.0-2.1; P = .049; 12 months, 0.6; 95% CI, -0.5 to 1.8; P = .28; and overall, χ2 = 13.4, with 4 degrees of freedom; P = .01). Emergency department visits were lower at 12 months for the intervention groups vs the control group (16 [6.2%] vs 17 [12.7%]; P = .03; adjusted odds ratio, 0.8; 95% CI, 0.6-0.99; P = .03). Statistically significant improvements were observed for the intervention vs control patients in quality of life (overall effect: χ2 = 10.5, with 4 degrees of freedom; P = .01), medication adherence (overall effect: χ2 = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique (metered-dose inhaler technique, correctly completed steps at 12 months, median [range]: 75% [0%-100%] vs 58% [0%-100%]). No significant differences in outcomes were observed between patients receiving the intervention in home vs practice settings. CONCLUSIONS AND RELEVANCE: An intervention directed by patients' needs and barriers improved asthma outcomes and self-management behaviors among older adults. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02316223.

Successful recruitment and retention of diverse participants in a genomics clinical trial: a good invitation to a great party.

PURPOSE: African ancestry (AA) individuals are inadequately included in translational genomics research, limiting generalizability of findings and benefits of genomic discoveries for populations already facing disproportionately poor health outcomes. We aimed to determine the impact of stakeholder-engaged strategies on recruitment and retention of AA adult patients into a clinical trial testing them for renal risk variants nearly exclusive to AAs. METHODS: Our academic-clinical-community team developed ten key strategies that recognize AAs' barriers and facilitators for participation. Using electronic health records (EHRs), we identified potentially eligible patients. Recruiters reached out through letters, phone calls, and at medical visits. RESULTS: Of 5481 AA patients reached, 51% were ineligible, 37% enrolled, 4% declined, 7% were undecided when enrollment finished. We retained 93% at 3-month and 88% at 12-month follow-up. Those enrolled are more likely female, seen at community sites, and reached through active strategies, than those who declined. Those retained are more likely female, health-literate, and older. While many patients have low income, low clinician trust, and perceive racism in health care, none of these attributes correlate with retention. CONCLUSION: With robust stakeholder engagement, recruiters from patients' communities, and active approaches, we successfully recruited and retained AA patients into a genomic clinical trial.

Views Of Primary Care Providers On Testing Patients For Genetic Risks For Common Chronic Diseases.

We surveyed 488 primary care providers in community and academic practices in New York City in the period 2014-16 about their views on genetic testing for chronic diseases. The majority of the providers, most of whom were current or recent physicians in training, had had formal genetics education and had positive views of the utility of genetic testing. However, they felt unprepared to work with patients at high risk for genetic conditions and were not confident about interpreting test results. Many were concerned that genetic testing might lead to insurance discrimination and lacked trust in companies that offer genetic tests. These findings point to some of the attitudes and knowledge gaps among the providers that should be considered in the clinical implementation of genomic medicine for chronic conditions. Enhanced training, guidelines, clinical tools, and awareness of patient protections might support the effective adoption of genomic medicine by primary care providers.

A risk-based intervention approach to eliminate diabetes health disparities.

Type 2 diabetes plays a major role in racial/ethnic health disparities. We conducted the first study to examine whether multifaceted interventions targeting patients with poorly controlled diabetes (HgbA1c >9%) can reduce racial/ethnic disparities in diabetes control. Among 4595 patients with diabetes at a Federally Qualified Health Center in New York, a higher percentage of blacks (32%) and Hispanics/Latinos (32%) had poorly controlled diabetes than whites (25%) at baseline (prevalence ratio, 1.28; 95% CI, 1.14-1.43; P<0.001). After four years, this percentage was reduced in all groups (blacks, 21%; Hispanics/Latinos, 20%; whites, 20%; P<0.001 for each relative to baseline). Disparities in diabetes control also were significantly reduced (change in disparity relative to whites: blacks, P=0.03; Hispanics/Latinos, P=0.008). In this diverse population, interventions targeting patients with poorly controlled diabetes not only improved diabetes control in all racial/ethnic groups, but significantly reduced disparities. This approach warrants further testing and may help reduce disparities in other populations.

Implementation of Care Management: An Analysis of Recent AHRQ Research.

Care management (CM) is a promising team-based, patient-centered approach "designed to assist patients and their support systems in managing medical conditions more effectively." As little is known about its implementation, this article describes CM implementation and associated lessons from 12 Agency for Healthcare Research and Quality-sponsored projects. Two rounds of data collection resulted in project-specific narratives that were analyzed using an iterative approach analogous to framework analysis. Informants also participated as coauthors. Variation emerged across practices and over time regarding CM services provided, personnel delivering these services, target populations, and setting(s). Successful implementation was characterized by resource availability (both monetary and nonmonetary), identifying as well as training employees with the right technical expertise and interpersonal skills, and embedding CM within practices. Our findings facilitate future context-specific implementation of CM within medical homes. They also inform the development of medical home recognition programs that anticipate and allow for contextual variation.

A Culture of Understanding: Reflections and Suggestions from a Genomics Research Community Board.

There has been limited community engagement in the burgeoning field of genomics research. In the wake of a new discovery of genetic variants that increase the risk of kidney failure and are almost unique to people of African ancestry, community and clinical leaders in Harlem, New York, formed a community board to inform the direction of related research. The board advised all aspects of a study to assess the impact of testing for these genetic variants at primary care sites that serve diverse populations, including explaining genetic risk to participants. By reflecting on the board's experiences, we found that community voices can have tangible impact on research that navigates the controversial intersection of race, ancestry, and genomics by heightening vigilance, fostering clear communication between researchers and the community, and encouraging researchers to cede some control. Our reflections and work provide a strong justification for longitudinal community partnerships in genomics research.

Patient Beliefs Have a Greater Impact Than Barriers on Medication Adherence in a Community Health Center.

PURPOSE: Nonadherence to medicines contributes to poor health outcomes, especially for patients with complicated medicine regimens. We examined adherence among patients at a family health center and the impact that barriers to getting medicines and negative beliefs about medicines have on adherence. METHODS: A survey was administered incorporating the 8-item Morisky Medication Adherence Scale, questions from the Beliefs about Medicine Questionnaire, and questions about patients' external barriers to getting medicines. Low adherence was examined by any external barrier and by higher negative beliefs, adjusting for patient characteristics. RESULTS: The convenience sample of 343 participants is demographically representative of the larger population. Among these patients, 54% report low adherence, 51% have at least 1 barrier to adherence, and 52% report more negative than positive beliefs about medicines. When beliefs and barriers are examined together, patients with negative beliefs are 49% less likely to adhere than those with more positive beliefs, whereas barriers show no significant impact on adherence. CONCLUSIONS: Negative beliefs about medicines are as prevalent in this population as external barriers to accessing medicines, but negative beliefs were more significantly associated with adherence than external barriers. Physicians should identify and address patients' negative beliefs about medicines to improve adherence rates.

Effects of workload, work complexity, and repeated alerts on alert fatigue in a clinical decision support system.

BACKGROUND: Although alert fatigue is blamed for high override rates in contemporary clinical decision support systems, the concept of alert fatigue is poorly defined. We tested hypotheses arising from two possible alert fatigue mechanisms: (A) cognitive overload associated with amount of work, complexity of work, and effort distinguishing informative from uninformative alerts, and (B) desensitization from repeated exposure to the same alert over time. METHODS: Retrospective cohort study using electronic health record data (both drug alerts and clinical practice reminders) from January 2010 through June 2013 from 112 ambulatory primary care clinicians. The cognitive overload hypotheses were that alert acceptance would be lower with higher workload (number of encounters, number of patients), higher work complexity (patient comorbidity, alerts per encounter), and more alerts low in informational value (repeated alerts for the same patient in the same year). The desensitization hypothesis was that, for newly deployed alerts, acceptance rates would decline after an initial peak. RESULTS: On average, one-quarter of drug alerts received by a primary care clinician, and one-third of clinical reminders, were repeats for the same patient within the same year. Alert acceptance was associated with work complexity and repeated alerts, but not with the amount of work. Likelihood of reminder acceptance dropped by 30% for each additional reminder received per encounter, and by 10% for each five percentage point increase in proportion of repeated reminders. The newly deployed reminders did not show a pattern of declining response rates over time, which would have been consistent with desensitization. Interestingly, nurse practitioners were 4 times as likely to accept drug alerts as physicians. CONCLUSIONS: Clinicians became less likely to accept alerts as they received more of them, particularly more repeated alerts. There was no evidence of an effect of workload per se, or of desensitization over time for a newly deployed alert. Reducing within-patient repeats may be a promising target for reducing alert overrides and alert fatigue.

A qualitative investigation of the impact of asthma and self-management strategies among older adults.

OBJECTIVE: We sought feedback from elderly patients living with asthma to understand their experience with assuming self-management roles for their asthma in order to inform the design and implementation of a primary care-based strategy that could best support their asthma control. METHODS: We held six focus groups with a total of 31 English- and Spanish-speaking older adults with a current diagnosis of asthma. Focus groups addressed the effect of asthma on patients' lives and self-management strategies. Transcripts were analyzed using constant comparative techniques. RESULTS: Asthma exerted a consistent effect on patients' physical and psychological well-being. Common barriers to self-care included misuse of controller medications and uncertainty whether shortness of breath, fatigue, and cough were due to their asthma or some other chronic illness. Patients developed coping strategies to continue with daily activities even when experiencing symptoms, but did not recognize attainable asthma quality of life. CONCLUSIONS: Asthma had a distinct impact on elderly adults' quality of life; due to their longstanding history with this condition, many patients had accepted these symptoms as a "new normal." Developing strategies to reorient patients' perceptions of the possibilities for managing their illness will be critical to the success of asthma self-management support programs specific to older adults.

The IGNITE network: a model for genomic medicine implementation and research.

BACKGROUND: Patients, clinicians, researchers and payers are seeking to understand the value of using genomic information (as reflected by genotyping, sequencing, family history or other data) to inform clinical decision-making. However, challenges exist to widespread clinical implementation of genomic medicine, a prerequisite for developing evidence of its real-world utility. METHODS: To address these challenges, the National Institutes of Health-funded IGNITE (Implementing GeNomics In pracTicE; www.ignite-genomics.org ) Network, comprised of six projects and a coordinating center, was established in 2013 to support the development, investigation and dissemination of genomic medicine practice models that seamlessly integrate genomic data into the electronic health record and that deploy tools for point of care decision making. IGNITE site projects are aligned in their purpose of testing these models, but individual projects vary in scope and design, including exploring genetic markers for disease risk prediction and prevention, developing tools for using family history data, incorporating pharmacogenomic data into clinical care, refining disease diagnosis using sequence-based mutation discovery, and creating novel educational approaches. RESULTS: This paper describes the IGNITE Network and member projects, including network structure, collaborative initiatives, clinical decision support strategies, methods for return of genomic test results, and educational initiatives for patients and providers. Clinical and outcomes data from individual sites and network-wide projects are anticipated to begin being published over the next few years. CONCLUSIONS: The IGNITE Network is an innovative series of projects and pilot demonstrations aiming to enhance translation of validated actionable genomic information into clinical settings and develop and use measures of outcome in response to genome-based clinical interventions using a pragmatic framework to provide early data and proofs of concept on the utility of these interventions. Through these efforts and collaboration with other stakeholders, IGNITE is poised to have a significant impact on the acceleration of genomic information into medical practice.

Expanding access to high-quality plain-language patient education information through context-specific hyperlinks.

Medical records, which are increasingly directly accessible to patients, contain highly technical terms unfamiliar to many patients. A federally qualified health center (FQHC) sought to help patients interpret their records by embedding context-specific hyperlinks to plain-language patient education materials in its portal. We assessed the impact of this innovation through a 3-year retrospective cohort study. A total of 12,877 (10% of all patients) in this safety net population had used the MPC links. Black patients, Latino patients comfortable using English, and patients covered by Medicaid were more likely to use the informational hyperlinks than other patients. The positive association with black race and Latino ethnicity remained statistically significant in multivariable models that controlled for insurance type. We conclude that many of the sociodemographic factors associated with the digital divide do not present barriers to accessing context-specific patient education information once in the portal. In fact, this type of highly convenient plain-language patient education may provide particular value to patients in traditionally disadvantaged groups.

Associations between healthcare quality and use of electronic health record functions in ambulatory care.

OBJECTIVES: Contemporary electronic health records (EHRs) offer a wide variety of features, creating opportunities to influence healthcare quality in different ways. This study was designed to assess the relationship between physician use of individual EHR functions and healthcare quality. MATERIALS AND METHODS: Sixty-five providers eligible for "meaningful use" were included. Data were abstracted from office visit records during the study timeframe (183 095 visits with 61 977 patients). Three EHR functions were considered potential predictors: acceptance of best practice alerts, use of order sets, and viewing panel-level reports. Eighteen clinical quality measures from the "meaningful use" program were abstracted. RESULTS: Use of condition-specific best-practice alerts and order sets was associated with better scores on clinical quality measures capturing processes in diabetes, cancer screening, tobacco cessation, and pneumonia vaccination. For example, providers above the median in use of tobacco-related alerts had higher performance on tobacco cessation intervention metrics (median 80.6% vs. 66.7%; P < .001), and providers above the median in use of diabetes order sets had higher quality on diabetes low density lipoprotein (LDL) testing (68.2% vs. 59.5%; P == .001). Post hoc examination of the results showed that the positive associations were with measures of healthcare processes (such as rates of LDL testing), whereas there were no positive associations with measures of healthcare outcomes (such as LDL levels). DISCUSSION: Among primary care providers in the ambulatory setting using a single EHR, intensive use of certain EHR functions was associated with increased adherence to recommended care as measured by performance on electronically reported "meaningful use" quality measures. This study is relevant to current policy as it uses quality metrics constructed by contemporary certified EHR technology, and quantitative EHR use metrics rather than self-reported use. CONCLUSION: In the early stages of the "meaningful use" program, use of specific EHR functions was associated with higher performance on healthcare process metrics.

Teens, technology, and health care.

Teens are avid users of new technologies and social media. Nearly 95% of US adolescents are online at least occasionally. Health care professionals and organizations that work with teens should identify online health information that is both accurate and teen friendly. Early studies indicate that some of the new health technology tools are acceptable to teens, particularly texting, computer-based psychosocial screening, and online interventions. Technology is being used to provide sexual health education, medication reminders for contraception, and information on locally available health care services. This article reviews early and emerging studies of technology use to promote teen health.

How is the electronic health record being used? Use of EHR data to assess physician-level variability in technology use.

BACKGROUND: Studies of the effects of electronic health records (EHRs) have had mixed findings, which may be attributable to unmeasured confounders such as individual variability in use of EHR features. OBJECTIVE: To capture physician-level variations in use of EHR features, associations with other predictors, and usage intensity over time. METHODS: Retrospective cohort study of primary care providers eligible for meaningful use at a network of federally qualified health centers, using commercial EHR data from January 2010 through June 2013, a period during which the organization was preparing for and in the early stages of meaningful use. RESULTS: Data were analyzed for 112 physicians and nurse practitioners, consisting of 430,803 encounters with 99,649 patients. EHR usage metrics were developed to capture how providers accessed and added to patient data (eg, problem list updates), used clinical decision support (eg, responses to alerts), communicated (eg, printing after-visit summaries), and used panel management options (eg, viewed panel reports). Provider-level variability was high: for example, the annual average proportion of encounters with problem lists updated ranged from 5% to 60% per provider. Some metrics were associated with provider, patient, or encounter characteristics. For example, problem list updates were more likely for new patients than established ones, and alert acceptance was negatively correlated with alert frequency. CONCLUSIONS: Providers using the same EHR developed personalized patterns of use of EHR features. We conclude that physician-level usage of EHR features may be a valuable additional predictor in research on the effects of EHRs on healthcare quality and costs.

Implementing Institute of Medicine recommendations on collection of patient race, ethnicity, and language data in a community health center.

The Institute for Family Health is one of the first health care organizations to implement the 2009 Institute of Medicine recommendations on collection of patient race, ethnicity, and language data as a means of identifying and addressing health disparities. This paper describes the implementation process and lessons learned from the project.

Context matters: the experience of 14 research teams in systematically reporting contextual factors important for practice change.

PURPOSE: We aimed to advance the internal and external validity of research by sharing our empirical experience and recommendations for systematically reporting contextual factors. METHODS: Fourteen teams conducting research on primary care practice transformation retrospectively considered contextual factors important to interpreting their findings (internal validity) and transporting or reinventing their findings in other settings/situations (external validity). Each team provided a table or list of important contextual factors and interpretive text included as appendices to the articles in this supplement. Team members identified the most important contextual factors for their studies. We grouped the findings thematically and developed recommendations for reporting context. RESULTS: The most important contextual factors sorted into 5 domains: (1) the practice setting, (2) the larger organization, (3) the external environment, (4) implementation pathway, and (5) the motivation for implementation. To understand context, investigators recommend (1) engaging diverse perspectives and data sources, (2) considering multiple levels, (3) evaluating history and evolution over time, (4) looking at formal and informal systems and culture, and (5) assessing the (often nonlinear) interactions between contextual factors and both the process and outcome of studies. We include a template with tabular and interpretive elements to help study teams engage research participants in reporting relevant context. CONCLUSIONS: These findings demonstrate the feasibility and potential utility of identifying and reporting contextual factors. Involving diverse stakeholders in assessing context at multiple stages of the research process, examining their association with outcomes, and consistently reporting critical contextual factors are important challenges for a field interested in improving the internal and external validity and impact of health care research.