"Advocates for Each Other": The creation and evaluation of a pragmatic peer navigation program for black patients in primary care with uncontrolled hypertension.

BACKGROUND: Black individuals in the U.S. and in our primary care clinic experience worse control of blood pressure compared to White individuals. OBJECTIVE: To address this inequity, our objectives were to (1) elicit from patients and community members their ideas for barriers and facilitators to blood pressure control; and (2) use their input to design and pilot a navigator program for Black patients in our clinic to improve blood pressure management. PATIENT INVOLVEMENT: We conducted three focus groups with 27 individuals and identified two main areas of need that informed the peer navigator program: (1) community-based services and (2) skill development for hypertension self-management. METHODS: Peer navigators from the Black community called participants at least monthly for 6-12 months and connected them with medical and social services. Available blood pressure data was used as the primary outcome to measure change pre- to post-peer navigation program. RESULTS: Among 499 eligible patients in the clinic, 53 (10.6%) enrolled in the peer navigation program. For those with baseline and follow-up blood pressure data, mean systolic blood pressure decreased from 155.9 to 142.4 mmHg after the program (change of -13.6, 95% CI -24.7 to -2.4) for the enrolled patients (N = 17) and from 139.1 to 137.1 mmHg (change of -2.5, -4.8 to 1.9) for unenrolled, comparison patients (N = 183). DISCUSSION: This community-informed peer navigation program to support Black patients with uncontrolled hypertension led to a 11.1 mmHg greater decrease in average systolic blood pressure for enrolled patients compared to the comparison group. However, the enrolled group started with a significantly higher systolic blood pressure at baseline with more room for improvement. While this study was conducted during the pandemic years, low uptake of this program needs to be addressed in expansion efforts. PRACTICAL VALUE: Clinic-based peer navigation for hypertension improved blood pressure control and was highly regarded by the subset of enrolled patients. Increasing uptake and sustainable funding for non-billable clinic roles remain areas of need. FUNDING: Grant from the Pacific Hospital Preservation & Development Authority.

A rapid priority setting exercise combining existing, emergent evidence with stakeholder knowledge identified broad topic uncertainties.

OBJECTIVES: The project aimed to rapidly identify priority topic uncertainties as a first step to identify future systematic review questions of pertinence to key international fecal incontinence (FI) stakeholders (patients, carers, health care professionals, policy makers and voluntary, community, or social enterprise representatives). The paper's aim is to share our methods, experience, and learning with other groups planning to deliver a rapid priority setting exercise. STUDY DESIGN AND SETTING: An evidence gap map incorporated three evidence streams: emerging evidence identified through horizon scanning; existing evidence identified through systematic searches of bibliographic databases; and FI stakeholder insights collected through an international survey. The evidence gap map was presented during an online workshop with stakeholders, where they shared their expertize to expand, refine, and rank topic uncertainties using ideation techniques, focus group discussions, consensus techniques, and online polling. RESULTS: The multistep methods used to deliver this priority setting exercise resulted in identification of broad priority topic uncertainties. The methods appear to have high acceptability and engagement with participants but await full evaluation. CONCLUSION: This project successfully followed robust methodology, building upon frameworks from published priority setting and evidence gap mapping projects while incorporating strong patient and public involvement components.

Trends in Utilization of Electronic Consultations Associated With Patient Payer and Language Among US Academic Medical Centers During the COVID-19 Pandemic.

Importance: Electronic consultations (eConsultations) are increasingly used to obtain specialist guidance, avoiding unnecessary face-to-face patient visits for certain clinical questions. During the COVID-19 pandemic, when in-person care was limited, eConsultations may have helped clinicians obtain specialist input to guide patient care. Objective: To understand how the use of eConsultations changed during the COVID-19 pandemic and whether trends in eConsultation utilization differed based on patient's payer and primary language. Design, Setting, and Participants: This retrospective cohort study was conducted at 6 academic medical centers in the United States, all participating in the Association of American Colleges Coordinating Optimal Referral Experiences program. Participants included adult patients who had an outpatient visit, referral, or eConsultation during the study period. Data were analyzed from June 4, 2019, to July 28, 2020. Main Outcomes and Measures: The primary outcome was the eConsultation proportion of specialty contact, defined as the number of completed eConsultations divided by the sum of the number of completed eConsultations and specialty referrals, expressed as a percentage. eConsultation percentages of specialty contact were further stratified by payer type and language. Payers included commercial, Medicare, Medicaid, self-pay or uninsured, and other. Primary language included English and non-English languages. Results: A total of 14 545 completed eConsultations and 189 776 referrals were included. More eConsultations were completed for English-speaking patients (11 363 eConsultations [95.0%]) than non-English-speaking patients (597 eConsultations [5.0%]). Patients with commercial insurance represented the highest number of completed eConsultations (8848 eConsultations [60.8%]) followed by Medicare (3891 eConsultations [26.8%]), Medicaid (930 eConsultations [6.4%]), other insurance (745 eConsultations [5.1%]), and self-pay or no insurance (131 eConsultations [0.9%]). At the start of the pandemic, across all academic medical centers, the percentage of specialty contact conducted via eConsultation significantly increased by 6.21% (95% CI, 4.97%-7.44%; P < .001). When stratified by payer and language, the percentage of specialty contact conducted via eConsultation significantly increased at the beginning of the pandemic for both English-speaking patients (change, 6.09% (95% CI, 4.82% to 7.37%; P < .001) and non-English-speaking patients (change, 8.48% [95% CI, 5.79% to 11.16%]; P < .001) and for all payers, except self-pay and uninsured patients (change, -0.21% [95% CI, [-1.35% to 0.92%]; P = .70). Conclusions and Relevance: This retrospective cohort study found that eConsultations provided an accessible mechanism for clinicians to receive specialist input when in-person care was limited.

Rapid priority setting exercise on faecal incontinence for Cochrane Incontinence.

OBJECTIVE: This rapid priority setting exercise aimed to identify, expand, prioritise and explore stakeholder (patients, carers and healthcare practitioners) topic uncertainties on faecal incontinence (FI). DESIGN: An evidence gap map (EGM) was produced to give a visual overview of emerging trial evidence; existing systematic review-level evidence and FI stakeholder topic uncertainties derived from a survey. This EGM was used in a knowledge exchange workshop that promoted group discussions leading to the prioritisation and exploration of FI stakeholder identified topic uncertainties. RESULTS: Overall, a mismatch between the existing and emerging evidence and key FI stakeholder topic uncertainties was found. The prioritised topic uncertainties identified in the workshop were as follows: psychological support; lifestyle interventions; long-term effects of living with FI; education; constipation and the cultural impact of FI. When these six prioritised topic uncertainties were explored in more depth, the following themes were identified: education; impact and burden of living with FI; psychological support; healthcare service improvements and inconsistencies; the stigma of FI; treatments and management; culturally appropriate management and technology and its accessibility. CONCLUSIONS: Topic uncertainties identified were broad and wide ranging even after prioritisation. More research is required to unpick the themes emerging from the in-depth discussion and explore these further to achieve a consensus on deliverable research questions.

Clinical Use of an Electronic Pre-Visit Questionnaire Soliciting Patient Visit Goals and Interim History: A Retrospective Comparison Between Safety-net and Non-Safety-net Clinics.

INTRODUCTION/OBJECTIVES: We examined an initial step towards co-generation of clinic notes by inviting patients to complete a pre-visit questionnaire that could be inserted into clinic notes by providers and describe the experience in a safety-net and non-safety-net clinic. METHODS: We sent an electronic pre-visit questionnaire on visit goals and interim history to patients at a safety-net clinic and a non-safety-net clinic before clinic visits. We compared questionnaire utilization between clinics during a one-year period and performed a chart review of a sample of patients to examine demographics, content and usage of patient responses to the questionnaire. RESULTS: While use was low in both clinics, it was lower in the safety-net clinic (3%) compared to the non-safety-net clinic (10%). We reviewed a sample of respondents and found they were more likely to be White compared to the overall clinic populations (p < 0.05). There were no statistically significant differences in patient-typed notes (word count and number of visit goals) between the safety-net and non-safety-net samples however, patients at the safety-net clinic were less likely to have all of their goals addressed within the PCP documentation, compared to the non-safety-net clinic. CONCLUSIONS: Given potential benefits of this questionnaire as a communication tool, addressing barriers to use of technology among vulnerable patients is needed, including access to devices and internet, and support from caregivers or culturally concordant peer navigators.

Care partners reading patients' visit notes via patient portals: Characteristics and perceptions.

BACKGROUND: Care partners are key members of patients' health care teams, yet little is known about their experiences accessing patient information via electronic portals. OBJECTIVE: To better understand the characteristics and perceptions of care partners who read patients' electronic visit notes. PATIENT INVOLVEMENT: Focus groups with diverse patients from a community health center provided input into survey development. METHODS: We contacted patient portal users at 3 geographically distinct sites in the US via email in 2017 for an online survey including open ended questions which we qualitatively analyzed. RESULTS: Respondents chose whether to answer as care partners (N = 874) or patients (N = 28,782). Among care partner respondents, 44% were spouses, 43% children/other family members, and 14% friends/neighbors/other. Both care partners and patients reported that access to electronic notes was very important for promoting positive health behaviors, but care partners' perceptions of importance were consistently more positive than patients' perceptions of engagement behaviors. Open-ended comments included positive benefits such as: help with remembering the plan for care, coordinating care with other doctors, decreasing stress of care giving, improving efficiency of visits, and supporting patients from a geographical distance. They also offered suggestions for improving electronic portal and note experience for care partners such as having a separate log on for care partners; having doctors avoid judgmental language in their notes; and the ability to prompt needed medical care for patients. DISCUSSION: Care partners value electronic access to patients' health information even more than patients. The majority of care partners were family members, whose feedback is important for improving portal design that effectively engages these care team members. PRACTICAL VALUE: Patient care in the time of COVID-19 increasingly requires social distancing which may place additional burden on care partners supporting vulnerable patients. Access to patient notes may promote quality of care by keeping care partners informed, and care partner's input should be used to optimize portal design and electronic access to patient information.

Patients Contributing to Visit Notes: Mixed Methods Evaluation of OurNotes.

BACKGROUND: Secure patient portals are widely available, and patients use them to view their electronic health records, including their clinical notes. We conducted experiments asking them to cogenerate notes with their clinicians, an intervention called OurNotes. OBJECTIVE: This study aims to assess patient and provider experiences and attitudes after 12 months of a pilot intervention. METHODS: Before scheduled primary care visits, patients were asked to submit a word-constrained, unstructured interval history and an agenda for what they would like to discuss at the visit. Using site-specific methods, their providers were invited to incorporate the submissions into notes documenting the visits. Sites served urban, suburban, and rural patients in primary care practices in 4 academic health centers in Boston (Massachusetts), Lebanon (New Hampshire), Denver (Colorado), and Seattle (Washington). Each practice offered electronic access to visit notes (open notes) to its patients for several years. A mixed methods evaluation used tracking data and electronic survey responses from patients and clinicians. Participants were 174 providers and 1962 patients who submitted at least 1 previsit form. We asked providers about the usefulness of the submissions, effects on workflow, and ideas for the future. We asked patients about difficulties and benefits of providing the requested information and ideas for future improvements. RESULTS: Forms were submitted before 9.15% (5365/58,652) eligible visits, and 43.7% (76/174) providers and 26.76% (525/1962) patients responded to the postintervention evaluation surveys; 74 providers and 321 patients remembered receiving and completing the forms and answered the survey questions. Most clinicians thought interim patient histories (69/74, 93%) and patient agendas (72/74, 97%) as good ideas, 70% (52/74) usually or always incorporated them into visit notes, 54% (40/74) reported no change in visit length, and 35% (26/74) thought they saved time. Their most common suggestions related to improving notifications when patient forms were received, making it easier to find the form and insert it into the note, and educating patients about how best to prepare their submissions. Patient respondents were generally well educated, most found the history (259/321, 80.7%) and agenda (286/321, 89.1%) questions not difficult to answer; more than 92.2% (296/321) thought sending answers before the visit a good idea; 68.8% (221/321) thought the questions helped them prepare for the visit. Common suggestions by patients included learning to write better answers and wanting to know that their submissions were read by their clinicians. At the end of the pilot, all participating providers chose to continue the OurNotes previsit form, and sites considered expanding the intervention to more clinicians and adapting it for telemedicine visits. CONCLUSIONS: OurNotes interests patients, and providers experience it as a positive intervention. Participation by patients, care partners, clinicians, and electronic health record experts will facilitate further development.

Hepatitis C treatment outcomes among patients treated in co-located primary care and addiction treatment settings.

BACKGROUND: Persons with substance use disorders face major barriers to hepatitis C virus (HCV) treatment. Co-location of addiction and HCV treatment is appealing, yet there are limited data on outcomes using this model. This study evaluated HCV outcomes of patients treated with direct-acting antivirals (DAAs) by primary care providers in two sites of co-located addiction/HCV care. METHODS: The study conducted a retrospective chart review for all patients receiving DAA treatment from 2016 to 2018 at 1) a hospital-based primary care clinic with an office-based buprenorphine program, and 2) a primary care clinic within an opioid treatment program (i.e. methadone clinic). The study classified patients into 3 groups according to treatment status: buprenorphine maintenance, methadone maintenance, or neither. Descriptive analyses compared patient demographics, clinical characteristics, adherence to monitoring and treatment, and the primary outcome of sustained virologic response at 12 weeks (SVR12), defined as an undetectable HCV viral load at least 12 weeks after completing treatment. RESULTS: This study included 50 patients who initiated DAA treatment. The majority of patients were unemployed (74.0%), did not smoke tobacco (54.0%), and had psychiatric comorbidities (80.0%). Many also experienced homelessness during treatment (22.0%) and experienced previous incarceration (36.0%). Only a few had recently injected drugs (4.0%). Seven of 7 (100%) patients were treated with buprenorphine, 21 of 24 (87.5%) patients were treated with methadone, and 17 of 19 (89.5%) patients receiving no opioid addiction treatment fully completed HCV DAA treatment. When including patients with missing SVR12 data with the cohort that did not achieve cure, we observe that 44 of 50 patients (88.0%) achieved SVR12. Excluding patients missing SVR12 data, we observed that 44 of 46 patients (95.7%) achieved SVR12. CONCLUSION: Persons with substance use disorders treated with DAAs in co-located primary care and addiction treatment settings can achieve high rates of cure despite significant comorbidities and barriers. DAA treatment should be expanded to co-located HCV and addiction settings.

Multiplatform molecular test performance in indeterminate thyroid nodules.

BACKGROUND: Approximately 25% of thyroid nodule fine-needle aspirates (FNAs) have cytology that is indeterminate for malignant disease. Accurate risk stratification of these FNAs with ancillary testing would reduce unnecessary thyroid surgery. METHODS: We evaluated the performance of an ancillary multiplatform test (MPTX) that has three diagnostic categories (negative, moderate, and positive). MPTX includes the combination of a mutation panel (ThyGeNEXT®) and a microRNA risk classifier (ThyraMIR®). A blinded, multicenter study was performed using consensus histopathology diagnosis among three pathologists to validate test performance. RESULTS: Unanimous consensus diagnosis was reached in 197 subjects with indeterminate thyroid nodules; 36% had disease. MPTX had 95% sensitivity (95% CI,86%-99%) and 90% specificity (95% CI,84%-95%) for disease in prevalence adjusted nodules with Bethesda III and IV cytology. Negative MPTX results ruledout disease with 97% negative predictive value (NPV; 95% CI,91%-99%) at a 30% disease prevalence, while positive MPTX results ruledin high risk disease with 75% positive predictive value (PPV; 95% CI,60%-86%). Such results are expected in four out of five Bethesda III and IV nodules tested, including RAS positive nodules in which the microRNA classifier was useful in rulingin disease. 90% of mutation panel false positives were due to analytically verified RAS mutations detected in benign adenomas. Moderate MPTX results had a moderate rate of disease (39%, 95% CI,23%-54%), primarily due to RAS mutations, wherein the possibility of disease could not be excluded. CONCLUSIONS: Our results emphasize that decisions for surgery should not solely be based on RAS or RAS-like mutations. MPTX informs management decisions while accounting for these challenges.

Patients Evaluate Visit Notes Written by Their Clinicians: a Mixed Methods Investigation.

BACKGROUND: Patients actively involved in their care demonstrate better health outcomes. Using secure internet portals, clinicians are increasingly offering patients access to their narrative visit notes (open notes), but we know little about their understanding of notes written by clinicians. OBJECTIVE: We examined patients' views on the clarity, accuracy, and thoroughness of notes, their suggestions for improvement, and associations between their perceptions and willingness to recommend clinicians to others. DESIGN: We conducted an online survey of patients in 3 large health systems, June-October 2017. We performed a mixed methods analysis of survey responses regarding a self-selected note. PARTICIPANTS: Respondents were 21,664 patients aged 18 years or older who had read at least 1 open note in the previous 12 months. MAIN MEASURES: We asked to what degree the patient recalled understanding the note, whether it described the visit accurately, whether anything important was missing, for suggestions to improve the note, and whether they would recommend the authoring clinician to others. KEY RESULTS: Nearly all patients (96%) reported they understood all or nearly all of the self-selected note, with few differences by clinician type or specialty. Overall, 93% agreed or somewhat agreed the note accurately described the visit, and 6% reported something important missing from the note. The most common suggestions for improvement related to structure and content, jargon, and accuracy. Patients who reported understanding only some or very little of the note, or found inaccuracies or omissions, were much less likely to recommend the clinician to family and friends. CONCLUSIONS: Patients overwhelmingly report understanding their visit notes and usually find them accurate, with few disparities according to sociodemographic or health characteristics. They have many suggestions for improving their quality, and if they understand a note poorly or find inaccuracies, they often have less confidence in their clinicians.

Correction: OpenNotes After 7 Years: Patient Experiences With Ongoing Access to Their Clinicians' Outpatient Visit Notes.

[This corrects the article DOI: 10.2196/13876.].

Electronic Consults for Infectious Diseases in a United States Multisite Academic Health System.

We launched Infectious Disease electronic consultations (eConsults) in 2018. During the first 15.5 months, primary care practitioners submitted 328 eConsults; the most frequent reasons were a positive culture or polymerase chain reaction (PCR) result, syphilis, and latent tuberculosis. Practitioners commonly requested advice on antimicrobial choice, clinical evaluation, and indications for treatment. Internal phone consultations decreased after eConsult implementation.

Incremental utility of expanded mutation panel when used in combination with microRNA classification in indeterminate thyroid nodules.

INTRODUCTION: Focused and expanded mutation panels were assessed for the incremental utility of using an expanded panel in combination with microRNA risk classification. METHODS: Molecular results were reviewed for patients who underwent either a focused mutation panel (ThyGenX®) or an expanded mutation panel (ThyGeNEXT®) for strong and weak oncogenic driver mutations and fusions. microRNA results (ThyraMIR®) predictive of malignancy, including strong positive results highly specific for malignancy, were examined. RESULTS: Results of 12 993 consecutive patients were reviewed (focused panel = 8619, expanded panel = 4374). The expanded panel increased detection of strong drivers by 8% (P < .001), with BRAFV600E and TERT promoters being the most common. Strong drivers were highly correlated with positive microRNA results of which 90% were strongly positive. The expanded panel increased detection of coexisting drivers by 4% (P < .001), with TERT being the most common partner often paired with RAS. It increased the detection of weak drivers, with RAS and GNAS being the most common. 49% of nodules with weak drivers had positive microRNA results of which 33% were strongly positive. The expanded panel also decreased the number of nodules lacking mutations and fusions by 15% (P < .001), with 8% of nodules having positive microRNA results of which 22% were strongly positive. CONCLUSIONS: Using expanded mutation panels that include less common mutations and fusions can offer increased utility when used in combination with microRNA classification, which helps to identify high risk of malignancy in the cases where risk is otherwise uncertain due to the presence of only weak drivers or the absence of all drivers.

Mortality After Discontinuation of Primary Care-Based Chronic Opioid Therapy for Pain: a Retrospective Cohort Study.

BACKGROUND: Despite known risks of using chronic opioid therapy (COT) for pain, the risks of discontinuation of COT are largely uncharacterized. OBJECTIVE: To evaluate mortality, prescription opioid use, and primary care utilization of patients discontinued from COT, compared with patients maintained on opioids. DESIGN: Retrospective cohort study of patients with chronic pain enrolled in an opioid registry as of May 2010. PARTICIPANTS: Patients with chronic pain enrolled in the opioid registry of a primary care clinic at an urban safety-net hospital in Seattle, WA. MAIN OUTCOMES AND MEASURES: Discontinuation from the opioid registry was the exposure of interest. Pre-specified main outcomes included mortality, prescription and primary care utilization data, and reasons for discontinuation. Data was collected through March 2015. KEY RESULTS: The study cohort comprised 572 patients with a mean age of 54.9 ± 10.1 years. COT was discontinued in 344 patients (60.1%); 254 (73.8%) discontinued patients subsequently filled at least one opioid prescription in Washington State, and 187 (54.4%) continued to visit the clinic. During the study period, 119 (20.8%) registry patients died, and 21 (3.7%) died of definite or possible overdose: 17 (4.9%) discontinued patients died of overdose, whereas 4 (1.75%) retained patients died of overdose. Most patients had at least one provider-initiated reason for COT discontinuation. Discontinuation of COT was associated with a hazard ratio for death of 1.35 (95% CI, 0.92 to 1.98, p = 0.122) and for overdose death of 2.94 (1.01-8.61, p = 0.049), after adjusting for age and race. CONCLUSIONS: In this cohort of patients prescribed COT for chronic pain, mortality was high. Discontinuation of COT did not reduce risk of death and was associated with increased risk of overdose death. Improved clinical strategies, including multimodal pain management and treatment of opioid use disorder, may be needed for this high-risk group.

Effect of lowering initiation thresholds in a primary care-based buprenorphine treatment program.

BACKGROUND: Office-based buprenorphine treatment is effective for opioid use disorder. Scant research has examined programmatic factors impacting successful initiation of treatment. To increase initiation of eligible patients, our buprenorphine program implemented changes to lower treatment thresholds. Most notable among these was elimination of a requirement that patients demonstrate abstinence from stimulants prior to initiating buprenorphine. METHODS: This observational, retrospective study included patients screened for primary care-based buprenorphine treatment under high- and low-threshold conditions from 2015 to 2017. Background characteristics and treatment data were extracted from the electronic medical record and clinical registry. Chi-squared tests were used to compare proportions of patients initiated within 90 days of screening and retained to 60 days after initiation, under both conditions. Multivariate logistic regression was employed to compare relative odds of buprenorphine initiation after adjustment for several covariates. All analyses were stratified by recent stimulant use. RESULTS: The sample of 168 patients included 96 in the high-threshold group and 72 in the low-threshold group. Among patients with recent stimulant use, low-threshold conditions were associated with a higher proportion of patients initiated (69% versus 35%, p = 0.002) and higher relative odds of initiation (aOR = 7.01, 95% CI = 2.26-21.80) but also with a lower proportion of patients retained (63% versus 100%, p = 0.004). Among patients without recent stimulant use, low-threshold conditions did not change these measures by a statistically significant margin. CONCLUSIONS: Lower-threshold policies may increase buprenorphine treatment initiation for patients with co-occurring stimulant use. However, patients using stimulants may require additional supports to remain engaged.

OpenNotes After 7 Years: Patient Experiences With Ongoing Access to Their Clinicians' Outpatient Visit Notes.

BACKGROUND: Following a 2010-2011 pilot intervention in which a limited sample of primary care doctors offered their patients secure Web-based portal access to their office visit notes, the participating sites expanded OpenNotes to nearly all clinicians in primary care, medical, and surgical specialty practices. OBJECTIVE: The aim of this study was to examine the ongoing experiences and perceptions of patients who read ambulatory visit notes written by a broad range of doctors, nurses, and other clinicians. METHODS: A total of 3 large US health systems in Boston, Seattle, and rural Pennsylvania conducted a Web-based survey of adult patients who used portal accounts and had at least 1 visit note available in a recent 12-month period. The main outcome measures included patient-reported behaviors and their perceptions concerning benefits versus risks. RESULTS: Among 136,815 patients who received invitations, 21.68% (29,656/136,815) responded. Of the 28,782 patient respondents, 62.82% (18,081/28,782) were female, 72.90% (20,982/28,782) were aged 45 years or older, 76.94% (22,146/28,782) were white, and 14.30% (4115/28,782) reported fair or poor health. Among the 22,947 who reported reading 1 or more notes, 3 out of 4 reported reading them for 1 year or longer, half reported reading at least 4 notes, and 37.74% (8588/22,753) shared a note with someone else. Patients rated note reading as very important for helping take care of their health (16,354/22,520, 72.62%), feeling in control of their care (15,726/22,515, 69.85%), and remembering the plan of care (14,821/22,516, 65.82%). Few were very confused (737/22,304, 3.3%) or more worried (1078/22,303, 4.83%) after reading notes. About a third reported being encouraged by their clinicians to read notes and a third told their clinicians they had read them. Less educated, nonwhite, older, and Hispanic patients, and individuals who usually did not speak English at home, were those most likely to report major benefits from note reading. Nearly all respondents (22,593/22,947, 98.46%) thought Web-based access to visit notes a good idea, and 62.38% (13,427/21,525) rated this practice as very important for choosing a future provider. CONCLUSIONS: In this first large-scale survey of patient experiences with a broad range of clinicians working in practices in which shared notes are well established, patients find note reading very important for their health management and share their notes frequently with others. Patients are rarely troubled by what they read, and those traditionally underserved in the United States report particular benefit. However, fewer than half of clinicians and patients actively address their shared notes during visits. As the practice continues to spread rapidly in the United States and internationally, our findings indicate that OpenNotes brings benefits to patients that largely outweigh the risks.

The Diagnostic Yield of Malignancy Comparing Cytology, FISH, and Molecular Analysis of Cell Free Cytology Brush Supernatant in Patients With Biliary Strictures Undergoing Endoscopic Retrograde Cholangiography (ERC): A Prospective Study.

BACKGROUND: Routine cytology of biliary stricture brushings obtained during endoscopic retrograde cholangiopancreatography (ERCP) has suboptimal sensitivity for malignancy. We compared the individual and combined ability of cytology, fluorescence in situ hybridization (FISH) analysis and PCR-based mutation profiling (MP) to detect malignancy in standard biliary brushings. METHODS: We performed a prospective study of patients undergoing ERCP using histology or 1 year follow-up to determine patient outcomes. MP was performed on free-DNA from biliary brushing specimens using normally discarded supernatant fluid. MP examined KRAS point mutations and tumor suppressor gene associated loss of heterozygosity mutations at 10 genomic loci. FISH examined chromosome specific gains or losses. RESULTS: A total of 101 patients were included in final analysis and 69% had malignancy. Cytology had 26% sensitivity and 100% specificity for malignancy. Using either FISH or MP in combination with cytology increased sensitivity to 44% and 56%, respectively. The combination of all 3 tests (cytology, FISH, and MP) had the highest sensitivity for malignancy (66%). There was no difference in the specificity of cytology, FISH or MP testing when examined alone or in combination. MP improved diagnostic yield of each procedure from 22% to 100%; FISH improved yield to 90%. MP detected 21 malignancies beyond that identified by cytology; FISH detected an additional 13. The combination of FISH and MP testing detected an additional 28 malignancies. CONCLUSIONS: Both MP and FISH are complimentary molecular tests that can significantly increase detection of biliary malignancies when used in combination with routine cytology of standard biliary brush specimens.

Incremental value of DNA analysis in pancreatic cysts stratified by clinical risk factors.

BACKGROUND AND AIMS: We determined the incremental predictive value of pancreatic cyst fluid molecular analysis to assessing malignancy risk over long-term follow-up of a well-characterized cohort, given the underlying predictive value of imaging parameters routinely used to triage such patients. METHODS: Patients who lacked initial cytologic malignancy in cyst fluid and had final pathology or a follow-up period of more than 2 years were included. Patient outcomes determined the malignancy-free survival of patients with high-risk stigmata (HRS), worrisome features (WFs), and DNA abnormalities. DNA analysis included 3 abnormalities: loss of heterozygosity mutations among a panel of tumor suppressor genes, Kras mutation, and elevated DNA quantity. RESULTS: Included were 478 patients; 209 had surgical pathology-derived outcomes and 269 had clinical follow-up of >2 years. Eleven percent had malignant outcome. Forty-two patients had HRS, 272 lacked both HRS and WFs, and 164 lacked HRS but had WFs. DNA abnormalities did not statistically change long-term malignancy risk in patients with HRS or in patients lacking both HRS and WFs. Among patients with WFs, the presence of ≥2 DNA abnormalities significantly increased malignancy risk (relative risk, 5.2; P = .002) and the absence of all DNA abnormalities significantly decreased risk (relative risk, .4; P = .040). Sensitivity analysis confirmed results of survival analysis over differing baseline malignancy probabilities. CONCLUSIONS: Our study defines the clinical characteristic of patients in which DNA abnormality testing has the greatest impact on patient outcomes. Use of DNA abnormality testing is supported in a carefully selected patient population limited to cysts with WFs.