Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): a Physician Cluster Randomized Trial.

BACKGROUND: For adults aged 76-85, guidelines recommend individualizing decision-making about whether to continue colorectal cancer (CRC) testing. These conversations can be challenging as they need to consider a patient's CRC risk, life expectancy, and preferences. OBJECTIVE: To promote shared decision-making (SDM) for CRC testing decisions for older adults. DESIGN: Two-arm, multi-site cluster randomized trial, assigning physicians to Intervention and Comparator arms. Patients were surveyed shortly after the visit to assess outcomes. Analyses were intention-to-treat. PARTICIPANTS AND SETTING: Primary care physicians affiliated with 5 academic and community hospital networks and their patients aged 76-85 who were due for CRC testing and had a visit during the study period. INTERVENTIONS: Intervention arm physicians completed a 2-h online course in SDM communication skills and received an electronic reminder of patients eligible for CRC testing shortly before the visit. Comparator arm received reminders only. MAIN MEASURES: The primary outcome was patient-reported SDM Process score (range 0-4 with higher scores indicating more SDM); secondary outcomes included patient-reported discussion of CRC screening, knowledge, intention, and satisfaction with the visit. KEY RESULTS: Sixty-seven physicians (Intervention n=34 and Comparator n=33) enrolled. Patient participants (n=466) were on average 79 years old, 50% with excellent or very good self-rated overall health, and 66% had one or more prior colonoscopies. Patients in the Intervention arm had higher SDM Process scores (adjusted mean difference 0.36 (95%CI (0.08, 0.64), p=0.01) than in the Comparator arm. More patients in the Intervention arm reported discussing CRC screening during the visit (72% vs. 60%, p=0.03) and had higher intention to follow through with their preferred approach (58.0% vs. 47.1, p=0.03). Knowledge scores and visit satisfaction did not differ significantly between arms. CONCLUSION: Physician training plus reminders were effective in increasing SDM and frequency of CRC testing discussions in an age group where SDM is essential. TRIAL REGISTRATION: The trial is registered on clinicaltrials.gov (NCT03959696).

Electronic physician notifications to improve guideline-based anticoagulation in atrial fibrillation: a randomized controlled trial.

BACKGROUND: Oral anticoagulants reduce the risk of stroke in patients with atrial fibrillation. However, many patients with atrial fibrillation at elevated stroke risk are not treated with oral anticoagulants. OBJECTIVE: To test whether electronic notifications sent to primary care physicians increase the proportion of ambulatory patients prescribed oral anticoagulants. DESIGN: Randomized controlled trial conducted from February to May 2017 within 18 practices in an academic primary care network. PARTICIPANTS: Primary care physicians (n = 175) and their patients with atrial fibrillation, at elevated stroke risk, and not prescribed oral anticoagulants. INTERVENTION: Patients of each physician were randomized to the notification or usual care arm. Physicians received baseline email notifications and up to three reminders with patient information, educational material and primary care guidelines for anticoagulation management, and surveys in the notification arm. MAIN MEASURES: The primary outcome was the proportion of patients prescribed oral anticoagulants at 3 months in the notification (n = 972) vs. usual care (n = 1364) arms, compared using logistic regression with clustering by physician. Secondary measures included survey-based physician assessment of reasons why patients were not prescribed oral anticoagulants and how primary care physicians might be influenced by the notification. KEY RESULTS: Over 3 months, a small proportion of patients were newly prescribed oral anticoagulants with no significant difference in the notification (3.9%, 95% CI 2.8-5.3%) and usual care (3.2%, 95% CI 2.4-4.2%) arms (p = 0.37). The most common, non-exclusive reasons why patients were not on oral anticoagulants included atrial fibrillation was transient (30%) or paroxysmal (12%), patient/family declined (22%), high bleeding risk (20%), fall risk (19%), and frailty (10%). For 95% of patients, physicians stated they would not change their management after reviewing the alert. CONCLUSIONS: Electronic physician notification did not increase anticoagulation in patients with atrial fibrillation at elevated stroke risk. Primary care physicians did not prescribe anticoagulants because they perceived the bleeding risk was too high or stroke risk was too low. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02950285.

Use of maternal health services: comparing refugee, immigrant and US-born populations.

Objectives To determine use of recommended maternal healthcare services among refugee and immigrant women in a setting of near-universal insurance coverage. Methods Refugee women age ≥18 years, who arrived in the US from 2001 to 2013 and received care at the same Massachusetts community health center, were matched by age, gender, and date of care initiation to Spanish-speaking immigrants and US-born controls. The primary outcome was initiation of obstetrical care within the first trimester (12 weeks gestation). Secondary outcomes were number of obstetrical visits and attending a postpartum visit. Results We included 375 women with 763 pregnancies (women/pregnancies: 53/116 refugee, 186/368 immigrant, 136/279 control). More refugees (20.6 %) and immigrants (15.0 %) had their first obstetric visit after 12 weeks gestation than controls (6.0 %, p < 0.001). In logistic regression models adjusted for age, education, insurance, BMI, and median census tract household income, both refugee (odds ratio [OR] 4.58, 95 % confidence interval [CI] 1.73-12.13) and immigrant (OR 2.21, 95 % CI 1.00-4.84) women had delayed prenatal care initiation. Refugees had fewer prenatal visits than controls (median 12 vs. 14, p < 0.001). Refugees (73.3 %) and immigrant (78.3 %) women were more likely to have postpartum care (controls 54.8 %, p < 0.001) with differences persisting after adjustment (refugee [OR 2.00, 95 % CI 1.04-3.83] and immigrant [OR 2.79, 95 % CI 1.72-4.53]). Conclusions for Practice Refugee and immigrant women had increased risk for delayed initiation of prenatal care, but greater use of postpartum visits. Targeted outreach may be needed to improve use of beneficial care.

Talking, not training, increased the accuracy of physicians' diagnosis of their patients' preferences for colon cancer screening.

OBJECTIVE: Identify if primary care physicians (PCPs) accurately understand patient preferences for colorectal cancer (CRC) testing, whether shared decision making (SDM) training improves understanding of patient preferences, and whether time spent discussing CRC testing improves understanding of patient preferences. METHODS: Secondary analysis of a trial comparing SDM training plus a reminder arm to a reminder alone arm. PCPs and their patients completed surveys after visits assessing whether they discussed CRC testing, patient testing preference, and time spent discussing CRC testing. We compared patient and PCP responses, calculating concordance between patient-physician dyads. Multilevel models tested for differences in preference concordance by arm or time discussing CRC. RESULTS: 382 PCP and patient survey dyads were identified. Most dyads agreed on whether CRC testing was discussed (82%). Only 52% of dyads agreed on the patient's preference. SDM training did not impact accuracy of PCPs preference diagnoses (55%v.48%,p = 0.22). PCPs were more likely to accurately diagnose patient's preferences when discussions occurred, regardless of length. CONCLUSION: Only half of PCPs accurately identified patient testing preferences. Training did not impact accuracy. Visits where CRC testing was discussed resulted in PCPs better understanding patient preferences. PRACTICE IMPLICATIONS: PCPs should take time to discuss testing and elicit patient preferences.

Predicting post-stroke cognitive impairment using electronic health record data.

Importance: Secondary prevention interventions to reduce post-stroke cognitive impairment (PSCI) can be aided by the early identification of high-risk individuals who would benefit from risk factor modification. Objective: To develop and evaluate a predictive model to identify patients at increased risk of PSCI over 5 years using data easily accessible from electronic health records. Design: Cohort study with patients enrolled between 2003-2016 with follow-up through 2022. Setting: Primary care practices affiliated with two academic medical centers. Participants: Individuals 45 years or older, without prior stroke or prevalent cognitive impairment, with primary care visits and an incident ischemic stroke between 2003-2016 (development/internal validation cohort) or 2010-2022 (external validation cohort). Exposures: Predictors of PSCI were ascertained from the electronic health record. Main Outcome: The outcome was incident dementia/cognitive impairment within 5 years and beginning 3 months following stroke, ascertained using ICD-9/10 codes. For model variable selection, we considered potential predictors of PSCI and constructed 400 bootstrap samples with two-thirds of the model derivation sample. We ran 10-fold cross-validated Cox proportional hazards models using a least absolute shrinkage and selection operator (LASSO) penalty. Variables selected in >25% of samples were included. Results: The analysis included 332 incident diagnoses of PSCI in the development cohort (n=3,741), and 161 and 128 incident diagnoses in the internal (n=1,925) and external (n=2,237) validation cohorts. The c-statistic for predicting PSCI was 0.731 (95% CI: 0.694-0.768) in the internal validation cohort, and 0.724 (95% CI: 0.681-0.766) in the external validation cohort. A risk score based on the beta coefficients of predictors from the development cohort stratified patients into low (0-7 points), intermediate (8-11 points), and high (12-35 points) risk groups. The hazard ratios for incident PSCI were significantly different by risk categories in internal (High, HR: 6.2, 95% CI 4.1-9.3; Intermediate, HR 2.7, 95% CI: 1.8-4.1) and external (High, HR: 6.1, 95% CI: 3.9-9.6; Intermediate, HR 2.8, 95% CI: 1.9-4.3) validation cohorts. Conclusions and Relevance: Five-year risk of PSCI can be accurately predicted using routinely collected data. Model output can be used to risk stratify and identify individuals at increased risk for PSCI for preventive efforts.

Predicting post-stroke cognitive impairment using electronic health record data.

BACKGROUND: Secondary prevention interventions to reduce post-stroke cognitive impairment (PSCI) can be aided by the early identification of high-risk individuals who would benefit from risk factor modification. AIMS: To develop and evaluate a predictive model to identify patients at increased risk of PSCI over 5 years using data easily accessible from electronic health records. METHODS: Cohort study that included primary care patients from two academic medical centers. Patients were aged 45 years or older, without prior stroke or prevalent cognitive impairment, with primary care visits and an incident ischemic stroke between 2003 and 2016 (development/internal validation cohort) or 2010 and 2022 (external validation cohort). Predictors of PSCI were ascertained from the electronic health record. The outcome was incident dementia/cognitive impairment within 5 years and beginning 3 months following stroke, ascertained using International Classification of Diseases, Ninth/Tenth Revision (ICD-9/10) codes. For model variable selection, we considered potential predictors of PSCI and constructed 400 bootstrap samples with two-thirds of the model derivation sample. We ran 10-fold cross-validated Cox proportional hazards models using a least absolute shrinkage and selection operator (LASSO) penalty. Variables selected in >25% of samples were included. RESULTS: The analysis included 332 incident diagnoses of PSCI in the development cohort (n = 3741), and 161 and 128 incident diagnoses in the internal (n = 1925) and external (n = 2237) validation cohorts, respectively. The C-statistic for predicting PSCI was 0.731 (95% confidence interval (CI): 0.694-0.768) in the internal validation cohort, and 0.724 (95% CI: 0.681-0.766) in the external validation cohort. A risk score based on the beta coefficients of predictors from the development cohort stratified patients into low (0-7 points), intermediate (8-11 points), and high (12-23 points) risk groups. The hazard ratios (HRs) for incident PSCI were significantly different by risk categories in internal (high, HR: 6.2, 95% CI: 4.1-9.3; Intermediate, HR: 2.7, 95% CI: 1.8-4.1) and external (high, HR: 6.1, 95% CI: 3.9-9.6; Intermediate, HR: 2.8, 95% CI: 1.9-4.3) validation cohorts. CONCLUSION: Five-year risk of PSCI can be accurately predicted using routinely collected data. Model output can be used to risk stratify and identify individuals at increased risk for PSCI for preventive efforts. DATA ACCESS STATEMENT: Mass General Brigham data contain protected health information and cannot be shared publicly. The data processing scripts used to perform analyses will be made available to interested researchers upon reasonable request to the corresponding author.

Identifying a Heterogeneous Effect of Atrial Fibrillation Screening in Older Adults: A Secondary Analysis of the VITAL-AF Trial.

Background: One-time atrial fibrillation (AF) screening trials have produced mixed results; however, it is unclear if there is a subset for whom screening is effective. Identifying such a subgroup would support targeted screening. Methods: We conducted a secondary analysis of VITAL-AF, a randomized trial of one-time, single-lead ECG screening during primary care visits. We tested two approaches to identify a subgroup where screening is effective. First, we developed an effect-based model using a T-learner. Specifically, we separately predicted the likelihood of AF diagnosis under screening and usual care conditions; the difference in probabilities was the predicted screening effect. Second, we used a validated AF risk model to test for a heterogeneous screening effect. We used interaction testing to determine if observed AF diagnosis rates in the screening and usual care groups differed when stratified by decile of the predicted screening effect and predicted AF risk. Results: Baseline characteristics were similar between the screening (n=15187) and usual care (n=15078) groups (mean age 74 years, 59% female). In the effect-based analysis, in the highest decile of predicted screening effectiveness (n=3026), AF diagnosis rates were higher in the screening group (6.50 vs. 3.06 per 100 person-years, rate difference 3.45, 95%CI 1.62 to 5.28). In this group, the mean age was 84 years and 68% were female. The risk-based analysis did not identify a subgroup where screening was more effective. Predicted screening effectiveness and predicted baseline AF risk were poorly correlated (Spearman coefficient 0.13). Conclusions: In a secondary analysis of the VITAL-AF trial, we identified a small subgroup where one-time screening was associated with increased AF diagnoses using an effect-based approach. In this study, predicted AF risk was a poor proxy for predicted screening effectiveness. These data caution against the assumption that high AF risk is necessarily correlated with high screening effectiveness.

A Lifestyle Modification Program for Secondary Prevention of Atrial Fibrillation: A Pilot Study.

Background: Lifestyle modification programs, such as cardiac rehabilitation, may reduce atrial fibrillation (AF) burden and improve quality of life (QOL), but remain unproven. The objective of this pilot study was to assess feasibility, acceptability, and preliminary effectiveness of an exercise and nutrition-based cardiac rehabilitation-like program for AF patients. Methods: We enrolled overweight adults aged ≥ 30 years with symptomatic AF in a 12-week cardiac lifestyle group program, including 6 virtual and 6 in-person visits. All visits included discussion and education about nutrition, exercise, and behavior modification. In-person visits included supervised aerobic exercise and strength training. Outcomes at baseline and 12 weeks included feasibility of participation, acceptability, change in weight and BMI, and changes in survey-based AF burden, symptoms, and QOL. Results: From 84 invitees, 11 (13.1%) were enrolled (mean age 64; baseline BMI 38 kg/m2); 9 (82%) completed the program. Patients attended an average of 9.7 (81%) visits (Range: 6-11). Mean weight loss was 9.1 pounds (Range: 0-16); mean BMI decrease was 1.4 kg/m2 (Range: 0-2.6). Patients found the program helpful overall: all reported making diet and exercise changes during the program. Compared to baseline, patients reported decreased AF burden (12.9 vs. 11.7, p = 0.03) and symptom (10.1 vs. 5.6, p = 0.003) scores at the conclusion of the program. Patients also reported increased QOL overall (68.9 vs. 86.4, p = 0.001). Conclusions: Participation in a cardiac rehab-like program was feasible and acceptable for overweight patients with symptomatic AF. Results suggest preliminary effectiveness of the program for reducing AF burden and symptoms and increasing QOL.

Screening for undiagnosed atrial fibrillation using a single-lead electrocardiogram at primary care visits: patient uptake and practitioner perspectives from the VITAL-AF trial.

BACKGROUND: Screening for atrial fibrillation (AF) is appealing because AF is common, when undiagnosed may increase stroke risk, and stroke is preventable with anticoagulants. This study assessed patient and primary care practitioner (PCP) acceptability of screening for AF using a 30-s single-lead electrocardiogram (SL-ECG) during outpatient visits. METHODS: Secondary analyses of a cluster randomized trial. All patients ≥ 65 years old without prevalent AF seen during a 1-year period and their PCPs. Screening using a SL-ECG was performed by medical assistants during check-in at 8 intervention sites among verbally consenting patients. PCPs were notified of "possible AF" results; management was left to their discretion. Control practices continued with usual care. Following the trial, PCPs were surveyed about AF screening. Outcomes included screening uptake and results, and PCP preferences for screening. RESULTS: Fifteen thousand three hundred ninety three patients were seen in intervention practices (mean age 73.9 years old, 59.7% female). Screening occurred at 78% of 38,502 individual encounters, and 91% of patients completed ≥ 1 screening. The positive predictive value of a "Possible AF" result (4.7% of SL-ECG tracings) at an encounter prior to a new AF diagnosis was 9.5%. Same-day 12-lead ECGs were slightly more frequent among intervention (7.0%) than control (6.2%) encounters (p = 0.07). Among the 208 PCPs completing a survey (73.6%; 78.9% intervention, 67.7% control), most favored screening for AF (87.2% vs. 83.6%, respectively), though SL-ECG screening was favored by intervention PCPs (86%) while control PCPs favored pulse palpation (65%). Both groups were less certain if AF screening should be done outside of office visits with patch monitors (47% unsure) or consumer devices (54% unsure). CONCLUSIONS: Though the benefits and harms of screening for AF remain uncertain, most older patients underwent screening and PCPs were able to manage SL-ECG results, supporting the feasibility of routine primary care screening. PCPs exposed to a SL-ECG device preferred it over pulse palpation. PCPs were largely uncertain about AF screening done outside of practice visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT03515057. Registered May 3, 2018.

Effect of clinic-based single-lead electrocardiogram rhythm assessment on oral anticoagulation prescriptions in patients with previously diagnosed atrial fibrillation.

Background: Despite benefits of oral anticoagulation (OAC), many individuals with diagnosed atrial fibrillation (AF) do not receive OAC. Objective: The purpose of this study was to assess whether cardiac rhythm assessment for AF impacted use of OAC in patients with previously diagnosed AF. Methods: VITAL-AF was a cluster randomized controlled trial conducted in 16 primary care practices assessing the efficacy of AF rhythm assessment with single-lead electrocardiogram in routine care. Patients 65 years and older were offered rhythm assessment at visits. In this secondary analysis, we evaluated rhythm assessment uptake and compared initiation and discontinuation of OAC in patients with previously diagnosed AF from intervention and control arms over 1 year. Results: The study included 4593 patients with previously diagnosed AF (2250 intervention; 2343 control). In the intervention arm, 2022 (89.9%) completed rhythm assessment (median 2 visits with rhythm assessment) and 40.1% had ≥1 "Possible AF" result. Initiation of OAC was similar in the intervention (17.7%) and control (19.1%) arms but was influenced by the rhythm assessment result: higher with a "Possible AF" (26.1%; adjusted odds ratio [aOR] 1.62; 95% confidence interval [CI] 1.04-2.51), and lower with a "Normal" result (9.9%; aOR 0.45; 95% CI 0.29-0.71) compared to control. OAC discontinuation was similar in the intervention (6.3%) and control (7.2%) arms, with lower discontinuation with a "Possible AF" result (3.8%; aOR 0.51; 95% CI 0.32-0.81). Conclusions: Including patients with previously diagnosed AF in a point-of-care rhythm assessment strategy did not increase overall OAC use compared to the control arm. However, the rhythm assessment result influenced both initiation and discontinuation of OAC.

Performance of Single-Lead Handheld Electrocardiograms for Atrial Fibrillation Screening in Primary Care: The VITAL-AF Trial.

Background: Handheld single-lead electrocardiographic (1L ECG) devices are increasingly used for atrial fibrillation (AF) screening, but their real-world performance is not well understood. Objectives: The purpose of this study was to quantify the diagnostic test characteristics of 1L ECG automated interpretations for prospective AF screening. Methods: We calculated the diagnostic test characteristics of the AliveCor KardiaMobile 1L ECG (AliveCor, US) algorithm using unblinded cardiologist overread as the gold standard using single 30s tracings administered by medical assistants among individuals aged ≥65 years participating in the VITAL-AF trial (NCT03515057) of population-based AF screening embedded within routine primary care. Results: A total of 14,230 individuals (mean age 74 ± 7 years, 60% women, 82% White) had 31,376 tracings reviewed by 13 cardiologists. A total of 24,906 (79.6%) tracings had an AliveCor interpretation of normal, 5,046 (16.1%) were unclassified, 797 (2.5%) were possible AF, and 573 (1.8%) were no analysis. Cardiologists read 808 (2.6%) tracings as AF. AliveCor possible AF had a PPV of 51.7% (95% CI: 47.8%-55.6%). AliveCor normal had an NPV of 99.8% (95% CI: 99.7%-99.8%). The AliveCor algorithm had an overall sensitivity of 51.0% (95% CI: 47.1%-54.9%) and a specificity of 98.7% (95% CI: 98.6%-98.9%). AliveCor tracings interpreted as unclassified (PPV 5.9%, 95% CI: 5.1%-6.7%) and no analysis (PPV 6.5%, 95% CI: 4.6%-8.9%) had low predictive values for AF and were increasingly prevalent at older ages (13.7% for age 65-69 years to 28.1% for age ≥85 years, P < 0.01). Conclusions: In an older primary care population undergoing AF screening with handheld 1L ECGs, automated algorithm interpretations were sufficiently accurate to exclude the presence of AF but not to establish an AF diagnosis.

Cohort design and natural language processing to reduce bias in electronic health records research.

Electronic health record (EHR) datasets are statistically powerful but are subject to ascertainment bias and missingness. Using the Mass General Brigham multi-institutional EHR, we approximated a community-based cohort by sampling patients receiving longitudinal primary care between 2001-2018 (Community Care Cohort Project [C3PO], n = 520,868). We utilized natural language processing (NLP) to recover vital signs from unstructured notes. We assessed the validity of C3PO by deploying established risk models for myocardial infarction/stroke and atrial fibrillation. We then compared C3PO to Convenience Samples including all individuals from the same EHR with complete data, but without a longitudinal primary care requirement. NLP reduced the missingness of vital signs by 31%. NLP-recovered vital signs were highly correlated with values derived from structured fields (Pearson r range 0.95-0.99). Atrial fibrillation and myocardial infarction/stroke incidence were lower and risk models were better calibrated in C3PO as opposed to the Convenience Samples (calibration error range for myocardial infarction/stroke: 0.012-0.030 in C3PO vs. 0.028-0.046 in Convenience Samples; calibration error for atrial fibrillation 0.028 in C3PO vs. 0.036 in Convenience Samples). Sampling patients receiving regular primary care and using NLP to recover missing data may reduce bias and maximize generalizability of EHR research.

Application of 2021 American Diabetes Association Glycemic Treatment Clinical Practice Recommendations in Primary Care.

OBJECTIVE: We aimed to identify the proportion of primary care patients meeting criteria for sodium-glucose cotransporter 2 inhibitors (SGLT2is) and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for cardiorenal comorbidities per 2021 American Diabetes Association (ADA) Standards of Care recommendations using readily available electronic health record (EHR) characteristics. RESEARCH DESIGN AND METHODS: We applied 2021 ADA recommendations to a primary care cohort of 13,350 adults with type 2 diabetes (T2D). RESULTS: We found that 33% of patients with diabetes would be eligible for an SGLT2i or GLP-1 RA based on cardiorenal comorbidities, 13% of patients met criteria for an SGLT2i based on heart failure or albuminuric chronic kidney disease (CKD), and 18% of patients met criteria for either agent based on atherosclerotic cardiovascular disease or CKD with an albumin-to-creatinine ratio of ≤300 mg/g. CONCLUSIONS: This EHR algorithm identified one-third of primary care patients with T2D as meeting criteria for SGLT2i and GLP-1 RA based on strict comorbidity definitions according to 2021 ADA recommendations.

Patient, provider, and clinic factors associated with the use of cervical cancer screening.

Cervical cancer screening delivery remains suboptimal. Understanding the multiple influences on use of screening is important to designing interventions. We describe the influence of patient, primary care provider (PCP), and clinic characteristics on whether a woman is up-to-date with cervical screening as of December 2016. PCPs (n = 194) and their female screen-eligible patients age 21-65 years (n = 32,115) were included in this cross-sectional analysis of patients from two primary care networks linked to a contemporaneous PCP survey. Principal independent variables for patients included: age, race, insurance, continuity of care; for PCP included: overall satisfaction with the practice of medicine, gender, hours worked per week, financial support for achieving clinical targets; and for clinic included: routine receipt of data on preventive care performance and language translation resources. Overall, 66.6% of women were up-to-date. Women were less likely to be up-to-date with cervical cancer screening if they were younger and were more likely to be screened if they were Black, Hispanic or Asian vs. White. Women with greater continuity of primary care or with a female PCP were more likely to be up-to-date (1.52; 1.33-1.75); those who received care in a clinic that was less prepared to manage language translation were less likely to be up-to-date (0.78; 0.65-0.95). Patient, provider, and clinic factors all influence use of cervical cancer screening. Systems interventions like improving continuity of care, promoting translation services, or enhanced efforts to track screening among patients of male PCPs may improve delivery.

Doctors of chiropractic working with or within integrated healthcare delivery systems: a scoping review protocol.

INTRODUCTION: Back and neck pain are the leading causes of disability worldwide. Doctors of chiropractic (DCs) are trained to manage these common conditions and can provide non-pharmacological treatment aligned with international clinical practice guidelines. Although DCs practice in over 90 countries, chiropractic care is rarely available within integrated healthcare delivery systems. A lack of DCs in private practice, particularly in low-income communities, may also limit access to chiropractic care. Improving collaboration between medical providers and community-based DCs, or embedding DCs in medical settings such as hospitals or community health centres, will improve access to evidence-based care for musculoskeletal conditions. METHODS AND ANALYSES: This scoping review will map studies of DCs working with or within integrated healthcare delivery systems. We will use the recommended six-step approach for scoping reviews. We will search three electronic data bases including Medline, Embase and Web of Science. Two investigators will independently review all titles and abstracts to identify relevant records, screen the full-text articles of potentially admissible records, and systematically extract data from selected articles. We will include studies published in English from 1998 to 2020 describing medical settings that have established formal relationships with community-based DCs (eg, shared medical record) or where DCs practice in medical settings. Data extraction and reporting will be guided by the Proctor Conceptual Model for Implementation Research, which has three domains: clinical intervention, implementation strategies and outcome measurement. Stakeholders from diverse clinical fields will offer feedback on the implications of our findings via a web-based survey. ETHICS AND DISSEMINATION: Ethics approval will not be obtained for this review of published and publicly accessible data, but will be obtained for the web-based survey. Our results will be disseminated through conference presentations and a peer-reviewed publication. Our findings will inform implementation strategies that support the adoption of chiropractic care within integrated healthcare delivery systems.

Designing a Strategy Trial for the Management of Gout: The Use of a Modified Delphi Panel.

OBJECTIVE: Disagreement exists between rheumatology and primary care societies regarding gout management. This paper describes a formal process for gathering input from stakeholders in the planning of a trial to compare gout management strategies. METHODS: We recruited patients, nurses, physician assistants, primary care clinicians, and rheumatologists to participate in a modified Delphi panel (mDP) to provide input on design of a trial focused on optimal management for primary care patients with gout. The 16 panelists received a plain-language briefing document that discussed the rationale for the trial, key clinical issues in gout, and aspects of trial design. The panelists also received information and considerations on nine voting questions (VQs), judged to be the key design questions. Cognitive interviews with panelists ensured that the VQs were understood by the range of panelists involved in the mDP. Panelists were asked to score all VQs from 1 (definitely no) to 9 (definitely yes). Two voting rounds were conducted-round 1 by email and round 2 by video conference. RESULTS: The VQs were modified through the cognitive interviews. The round 1 voting resulted in consensus on eight items, with consensus defined as median voting score in the same tercile (1-3, 4-6 or 7-9). Re-voting at the meeting (round 2) reached consensus on the remaining item. CONCLUSION: An mDP with various stakeholders facilitated consensus on the design of a trial of different management strategies for chronic gout. This method may be useful for designing trials of clinical questions with substantial disagreement across stakeholders.

A culturally tailored navigator program for colorectal cancer screening in a community health center: a randomized, controlled trial.

BACKGROUND: Minority racial/ethnic groups have low colorectal cancer (CRC) screening rates. OBJECTIVE: To evaluate a culturally tailored intervention to increase CRC screening, primarily using colonoscopy, among low income and non-English speaking patients. DESIGN: Randomized controlled trial conducted from January to October of 2007. SETTING: Single, urban community health center serving a low-income, ethnically diverse population. PATIENTS: A total of 1,223 patients 52-79 years of age overdue for CRC screening, randomized to intervention (n = 409) vs. usual care control (n = 814) groups. INTERVENTION: Intervention patients received an introductory letter with educational material followed by phone or in-person contact by a language-concordant "navigator." Navigators (n = 5) were community health workers trained to identify and address patient-reported barriers to CRC screening. Individually tailored interventions included patient education, procedure scheduling, translation and explanation of bowel preparation, and help with transportation and insurance coverage. Rates of colorectal cancer screening were assessed for intervention and usual care control patients. RESULTS: Over a 9-month period, intervention patients were more likely to undergo CRC screening than control patients (27% vs. 12% for any CRC screening, p < 0.001; 21% vs. 10% for colonoscopy completion, p < 0.001). The higher screening rate resulted in the identification of 10.5 polyps per 100 patients in the intervention group vs. 6.8 in the control group (p = 0.04). LIMITATIONS: Patients were from one health center. Some patients may have obtained CRC screening outside our system. CONCLUSIONS: A culturally tailored, language-concordant navigator program designed to identify and overcome barriers to colorectal cancer screening can significantly improve colonoscopy rates for low income, ethnically and linguistically diverse patients. ClinicalTrials.gov registration number: NCT00476970.