Prolonged Gastrointestinal Manifestations After Recovery From COVID-19.

BACKGROUND & AIMS: Acute enteric infections are well known to result in long-term gastrointestinal (GI) disorders. Although COVID-19 is principally a respiratory illness, it demonstrates significant GI tropism, possibly predisposing to prolonged gut manifestations. We aimed to examine the long-term GI impact of hospitalization with COVID-19. METHODS: Nested within a large-scale observational cohort study of patients hospitalized with COVID-19 across North America, we performed a follow-up survey of 530 survivors 12-18 months later to assess for persistent GI symptoms and their severity, and for the development of disorders of gut-brain interaction (DGBIs). Eligible patients were identified at the study site level and surveyed electronically. The survey instrument included the Rome IV Diagnostic Questionnaire for DGBI, a rating scale of 24 COVID-related symptoms, the Gastrointestinal Symptoms Rating Scale, and the Impact of Events-Revised trauma symptom questionnaire (a measure of posttraumatic stress associated with the illness experience). A regression analysis was performed to explore the factors associated with GI symptom severity at follow-up. RESULTS: Of the 530 invited patients, 116 responded (52.6% females; mean age, 55.2 years), and 73 of those (60.3%) met criteria for 1 or more Rome IV DGBI at follow-up, higher than the prevalence in the US general population (P < .0001). Among patients who experienced COVID-related GI symptoms during the index hospitalization (abdominal pain, nausea, vomiting, or diarrhea), 42.1% retained at least 1 of these symptoms at follow-up; in comparison, 89.8% of respondents retained any (GI or non-GI) COVID-related symptom. The number of moderate or severe GI symptoms experienced during the initial COVID-19 illness by self-report correlated with the development of DGBI and severity of GI symptoms at follow-up. Posttraumatic stress disorder (Impact of Events-Revised score ≥33) related to the COVID-19 illness experience was identified in 41.4% of respondents and those individuals had higher DGBI prevalence and GI symptom severity. Regression analysis revealed that higher psychological trauma score (Impact of Events-Revised) was the strongest predictor of GI symptom severity at follow-up. CONCLUSIONS: In this follow-up survey of patients 12-18 months after hospitalization with COVID-19, there was a high prevalence of DGBIs and persistent GI symptoms. Prolonged GI manifestations were associated with the severity of GI symptoms during hospitalization and with the degree of psychological trauma related to the illness experience.

User-Centered Design of a Clinical Tool for Shared Decision-making About Diet in Primary Care.

BACKGROUND: Health information technology is a leading cause of clinician burnout and career dissatisfaction, often because it is poorly designed by nonclinicians who have limited knowledge of clinicians' information needs and health care workflow. OBJECTIVE: Describe how we engaged primary care clinicians and their patients in an iterative design process for a software application to enhance clinician-patient diet discussions. DESIGN: Descriptive study of the steps followed when involving clinicians and their at-risk patients in the design of the content, layout, and flow of an application for collaborative dietary goal setting. This began with individual clinician and patient interviews to detail the desired informational content of the screens displayed followed by iterative reviews of intermediate and final versions of the program and its outputs. PARTICIPANTS: Primary care clinicians practicing in an urban federally qualified health center and two academic primary care clinics, and their patients who were overweight or obese with diet-sensitive conditions. MAIN MEASURES: Descriptions of the content, format, and flow of information from pre-visit dietary history to the display of evidence-based, guideline-driven suggested goals to final display of dietary goals selected, with information on how the patient might reach them and patients' confidence in achieving them. KEY RESULTS: Through three iterations of design and review, there was substantial evolution of the program's content, format, and flow of information. This involved "tuning" of the information desired: from too little, to too much, to the right amount displayed that both clinicians and patients believed would facilitate shared dietary goal setting. CONCLUSIONS: Clinicians' well-founded criticisms of the design of health information technology can be mitigated by involving them and their patients in the design of such tools that clinicians may find useful, and use, in their everyday medical practice.

Methods for development and application of data standards in an ontology-driven information model for measuring, managing, and computing social determinants of health for individuals, households, and communities evaluated through an example of asthma.

OBJECTIVE: To describe methods to approach application of data standards to integrate social determinants of health (SDoH) into EHRs through evaluation of a case of clinical decision support for pediatric asthma. MATERIALS AND METHODS: We identified a list of environmental factors important for managing pediatric asthma. We identified and integrated data from local outdoor air quality monitors with elements available from the clinic's EHR and self-reported indoor air quality questionnaire data. We assessed existing SDoH frameworks, assessment tools, and terminologies to identify representative data standards for these environmental SDoH measures. RESULTS: We found many-to-many relationships between the multiple framework domains, the environmental exposure measures collected, and existing standards. The majority of concepts did not accurately align with environmental exposure measurements. We propose an ontology-driven information framework methodology to apply standards for SDoH measurements to support measuring, managing, and computing SDoH data. DISCUSSION: To support methods of integrating SDoH data in the EHR via an ontology-driven information framework, a common SDoH ecosystem should be developed descriptively and prescriptively integrating framework domains, assessment tools, and standard ontologies to support future data sharing, aggregation, and interoperability. A hierarchical object-oriented information model should be adopted to manage SDoH to extend beyond patient-centered orientation of EHRs to orient to households and communities. CONCLUSION: SDoH data pose unique challenges and opportunities in collecting, measuring, and managing health information. Future work is needed to define data standards for implementing SDoH in a hierarchical, object-oriented information model representing multiple units of orientation including individuals, households, and communities.

A Medical School's Community Engagement Approach to Improve Population Health.

The U.S. spends trillions annually on health care that affects only 16% of health outcomes, with 84% driven by social factors, behaviors, and the physical environment. Medical schools are focusing more on these social determinants of health. We describe an academic community engagement unit with unique methods for partnering with the surrounding community to improve its members' health. Annually, a Call for Ideas asked community members to identify important health problems and propose solutions. A panel of community members and academic researchers reviewed submitted ideas and selects those addressing significant issues, that are also feasible, can be accomplished in a year, and are potentially scalable. Financial, project development, and evaluation support is provided where needed. Three Calls for Ideas generated 268 ideas from 249 individuals: 35% focused on social and behavioral factors, 33% on health behaviors, 16% on health care, and 6% on the physical environment. Half were submitted by individuals and half by community service organizations. Twenty-four (9%) were selected for implementation; 19 have been successfully implemented while 5 are under development. People with lived experience can identify barriers to health in their communities and effective mitigating interventions. By seeking community leadership and mutual benefit, academicians can gain community members' trust and meet both community and academic needs by establishing true partnerships, recognizing power dynamics and structural biases, and using language and approaches that respect the importance and power of lived experiences in identifying approaches to enhancing community health.

Use of Stakeholder Focus Groups to Define the Mission and Scope of a new Department of Population Health.

BACKGROUND: The focus and funding of US healthcare is evolving from volume to value-based, and healthcare leaders, managers, payers, and researchers are increasingly focusing on managing populations of patients. Simultaneously, there is increasing interest in getting "upstream" from disease management to promote health and prevent disease. Hence, the term "population health" has both clinical and community-based connotations relevant to the tripartite mission of US medical schools. OBJECTIVE: To seek broad input for the strategic development of the Department of Population Health in a new medical school at a tier 1 research university. DESIGN: Focus groups with facilitated consensus development. PARTICIPANTS: Eighty-one persons representing the Dell Medical School and other schools at the University of Texas at Austin, city/county government, community nonprofit organizations, and faculty from other local university schools along with selected national academic leaders. APPROACH: Focus groups with subsequent consensus development of emphases identified premeeting by participants by e-mail exchanges. KEY RESULTS: The resulting departmental strategic plan included scope of work, desired characteristics of leaders, and early impact activities in seven areas of interest: community engagement and health equity, primary care and value-based health, occupational and environment medicine, medical education, health services and community-based research, health informatics and data analysis, and global health. CONCLUSIONS: Medical schools should have a primary focus in population, most effectively at the departmental level. Engaging relevant academic and community stakeholders is an effective model for developing this emerging discipline in US medical schools.

Use of diphenhydramine as an adjunctive sedative for colonoscopy in patients on chronic opioid therapy: a randomized controlled trial.

BACKGROUND AND AIMS: Chronic opioid use increases tolerance to sedatives. Diphenhydramine is recommended for difficult-to-sedate patients during endoscopic procedures. We hypothesized that the addition of diphenhydramine to midazolam and fentanyl would improve objective and subjective measures of procedural sedation. METHODS: This randomized, double-blind, placebo-controlled trial included patients on chronic opioids undergoing colonoscopy. Patients were randomized to receive 50 mg of diphenhydramine intravenously (n = 61) or placebo (n = 58), in addition to fentanyl and midazolam. Baseline characteristics, amount of fentanyl and midazolam, procedure times, and adverse events were recorded. Quality of sedation was assessed by the physician and nurse. Patients rated pain and amnesia on a 10-point scale. RESULTS: There was no difference in amounts of fentanyl (125.4 ± 56.2 µg vs 126.9 ± 53.5 µg, P = .88) and midazolam (4.9 ± 2.1 mg vs 5 ± 1.9 mg, P = .79) used. The mean sedation scores from the physician (6.2 ± 1.1 vs 5.3 ± 1.2, P =.0002) and nurses (5.6 ± 1.5 vs 5.1 ± 1.4, P =.04) were statistically significant in favor of the diphenhydramine arm. Patient scores for pain (2.05 ± 2.17 vs 3.09 ± 3.95, P =.047) and amnesia (7.8 ± 3.4 vs 6.5 ± 3.8, P =.047) favored the group that received diphenhydramine. Qualitative assessment showed no significant difference between the groups. There was no difference in induction time (P = .86), procedure duration (P = .98), or recovery time (P = .16). Hypotensive episodes were more common in the placebo group (P = .027). CONCLUSIONS: In patients on chronic opioid therapy, administration of diphenhydramine does not allow for lower doses of procedural sedatives but improves quality of sedation without increasing the number of adverse events. (Clinical trial registration number: NCT T01967433.).

The Impact on Endoscopic Resource Utilization After a Targeted Intervention for Cost-Minimization of EGD and Colonoscopy.

OBJECTIVES: The need to define the cost of endoscopic procedures becomes increasingly important in an era of providing low-cost, high-quality care. We examined the impact of informing endoscopists of the cost of accessories and pathology specimens as a cost-minimization strategy. METHODS: We conducted a prospective observational cohort study of therapeutic outpatient esophagogastroduodenoscopy (EGD) and colonoscopy. During the pre-intervention phase (phase 1), the endoscopists were not briefed on the cost of accessories or pathology specimens obtained during the procedure. During a 3-week intervention phase and the post-intervention phase (phase 2) endoscopists were informed of the dollar value of accessories and pathology specimens after the completion of all procedures. In all cases the institutional costs (not charges) were used. The endoscopists were blinded to their observation. RESULTS: A total of 969 EGD, colonoscopy, and EGD+colonoscopy performed by 6 endoscopists were reviewed, 456 procedures in phase 1 and 513 procedures in phase 2. There was no significant difference between phases 1 and 2 in total device and pathology cost in dollars (188.8±151.4 vs. 188.9±151.8, P=0.99), total device cost (36.2±107.9 vs. 39.0±95.96, P=0.67) and total pathology cost (152.6±101.3 vs. 149.9±112.5, P=0.70). There was not a significant difference in total device and pathology cost when examined by specific procedures performed, or for any of the endoscopists between phases 1 and 2. CONCLUSIONS: Making endoscopists more cost conscious by informing them of the costs of each procedure during EGD and colonoscopy does not result in lower procedural costs. Analysis of cost-minimization strategies involving procedures in other health-care settings and procedures using high-cost accessories are warranted.

Industry Support of Medical Research: Important Opportunity or Treacherous Pitfall?

Pharmaceutical and device manufacturers fund more than half of the medical research in the U.S. Research funding by for-profit companies has increased over the past 20 years, while federal funding has declined. Research funding from for-profit medical companies is seen as tainted by many academicians because of potential biases and prior misbehavior by both investigators and companies. Yet NIH is encouraging partnerships between the public and private sectors to enhance scientific discovery. There are instances, such as methods for improving drug adherence and post-marketing drug surveillance, where the interests of academician researchers and industry could be aligned. We provide examples of ethically performed industry-funded research and a set of principles and benchmarks for ethically credible academic-industry partnerships that could allow academic researchers, for-profit companies, and the public to benefit.

Point and counterpoint: patient control of access to data in their electronic health records.

Information collection, storage, and management is central to the practice of health care. For centuries, patients' and providers' expectations kept medical records confidential between providers and patients. With the advent of electronic health records, patient health information has become more widely available to providers and health care managers and has broadened its potential use beyond individual patient care. Adhering to the principles of Fair Information Practice, including giving patients control over the availability and use of their individual health records, would improve care by fostering the sharing of sensitive information between patients and providers. However, adherence to such principles could put patients at risk for unsafe care as a result of both missed opportunities for providing needed care as well as provision of contraindicated care, as it would prevent health care providers from having full access to health information. Patients' expectations for the highest possible quality and safety of care, therefore, may be at odds with their desire to limit provider access to their health records. Conversely, provider expectations that patients would willingly seek care for embarrassing conditions and disclose sensitive information may be at odds with patients' information privacy rights. An open dialogue between patients and providers will be necessary to balance respect for patient rights with provider need for patient information.

Designing a patient-centered user interface for access decisions about EHR data: implications from patient interviews.

BACKGROUND: Electronic health records change the landscape of patient data sharing and privacy by increasing the amount of information collected and stored and the number of potential recipients. Patients desire granular control over who receives what information in their electronic health record (EHR), but there are no current patient interfaces that allow them to record their preferences for EHR access. OBJECTIVE: Our aim was to derive the user needs of patients regarding the design of a user interface that records patients' individual choices about who can access data in their EHRs. DESIGN: We used semi-structured interviews. SETTING: The study was conducted in Central Indiana. PARTICIPANTS: Thirty patients with data stored in an EHR, the majority of whom (70 %) had highly sensitive health EHR data, were included in the study. APPROACH: We conducted a thematic and quantitative analysis of transcribed interview data. KEY RESULTS: Patients rarely knew what data were in their EHRs, but would have liked to know. They also wanted to be able to control who could access what information in their EHR and wanted to be notified when their data we re accessed. CONCLUSIONS: We derived six implications for the design of a patient-centered tool to allow individual choice in the disclosure of EHR: easy patient access to their EHRs; an overview of current EHR sharing permissions; granular, hierarchical control over EHR access; EHR access controls based on dates; contextual privacy controls; and notification when their EHRs are accessed.

Patient preferences in controlling access to their electronic health records: a prospective cohort study in primary care.

INTRODUCTION: Previous studies have measured individuals' willingness to share personal information stored in electronic health records (EHRs) with health care providers, but none has measured preferences among patients when they are allowed to determine the parameters of provider access. METHODS: Patients were given the ability to control access by doctors, nurses, and other staff in a primary care clinic to personal information stored in an EHR. Patients could restrict access to all personal data or to specific types of sensitive information, and could restrict access for a specific time period. Patients also completed a survey regarding their understanding of and opinions regarding the process. RESULTS: Of 139 eligible patients who were approached, 105 (75.5 %) were enrolled, and preferences were collected from all 105 (100 %). Sixty patients (57 %) did not restrict access for any providers. Of the 45 patients (43 %) who chose to limit the access of at least one provider, 36 restricted access only to all personal information in the EHR, while nine restricted access of some providers to a subset of the their personal information. Thirty-four (32.3 %) patients blocked access to all personal information by all doctors, nurses, and/or other staff, 26 (24.8 %) blocked access by all doctors and/or nurses, and five (4.8 %) denied access to all doctors, nurses, and staff. CONCLUSIONS: A significant minority of patients chose to restrict access by their primary care providers to personal information contained in an EHR, and few chose to restrict access to specific types of information. More research is needed to identify patient goals and understanding of the implications when facing decisions of this sort, and to identify the impact of patient education regarding information contained in EHRs and their use in the clinical care setting.

Designing a system for patients controlling providers' access to their electronic health records: organizational and technical challenges.

BACKGROUND: Electronic health records (EHRs) are proliferating, and financial incentives encourage their use. Applying Fair Information Practice principles to EHRs necessitates balancing patients' rights to control their personal information with providers' data needs to deliver safe, high-quality care. We describe the technical and organizational challenges faced in capturing patients' preferences for patient-controlled EHR access and applying those preferences to an existing EHR. METHODS: We established an online system for capturing patients' preferences for who could view their EHRs (listing all participating clinic providers individually and categorically-physicians, nurses, other staff) and what data to redact (none, all, or by specific categories of sensitive data or patient age). We then modified existing data-viewing software serving a state-wide health information exchange and a large urban health system and its primary care clinics to allow patients' preferences to guide data displays to providers. RESULTS: Patients could allow or restrict data displays to all clinicians and staff in a demonstration primary care clinic, categories of providers (physicians, nurses, others), or individual providers. They could also restrict access to all EHR data or any or all of five categories of sensitive data (mental and reproductive health, sexually transmitted diseases, HIV/AIDS, and substance abuse) and for specific patient ages. The EHR viewer displayed data via reports, data flowsheets, and coded and free text data displayed by Google-like searches. Unless patients recorded restrictions, by default all requested data were displayed to all providers. Data patients wanted restricted were not displayed, with no indication they were redacted. Technical barriers prevented redacting restricted information in free textnotes. The program allowed providers to hit a "Break the Glass" button to override patients' restrictions, recording the date, time, and next screen viewed. Establishing patient-control over EHR data displays was complex and required ethical, clinical, database, and programming expertise and difficult choices to overcome technical and health system constraints. CONCLUSIONS: Assessing patients' preferences for access to their EHRs and applying them in clinical practice requires wide-ranging technical, clinical, and bioethical expertise, to make tough choices to overcome significant technical and organization challenges.

Provider responses to patients controlling access to their electronic health records: a prospective cohort study in primary care.

INTRODUCTION: Applying Fair Information Practice principles to electronic health records (EHRs) requires allowing patient control over who views their data. METHODS: We designed a program that captures patients' preferences for provider access to an urban health system's EHR. Patients could allow or restrict providers' access to all data (diagnoses, medications, test results, reports, etc.) or only highly sensitive data (sexually transmitted infections, HIV/AIDS, drugs/alcohol, mental or reproductive health). Except for information in free-text reports, we redacted EHR data shown to providers according to patients' preferences. Providers could "break the glass" to display redacted information. We prospectively studied this system in one primary care clinic, noting redactions and when users "broke the glass," and surveyed providers about their experiences and opinions. RESULTS: Eight of nine eligible clinic physicians and all 23 clinic staff participated. All 105 patients who enrolled completed the preference program. Providers did not know which of their patients were enrolled, nor their preferences for accessing their EHRs. During the 6-month prospective study, 92 study patients (88 %) returned 261 times, during which providers viewed their EHRs 126 times (48 %). Providers "broke the glass" 102 times, 92 times for patients not in the study and ten times for six returning study patients, all of whom had restricted EHR access. Providers "broke the glass" for six (14 %) of 43 returning study patients with redacted data vs. zero among 49 study patients without redactions (p = 0.01). Although 54 % of providers agreed that patients should have control over who sees their EHR information, 58 % believed restricting EHR access could harm provider-patient relationships and 71 % felt quality of care would suffer. CONCLUSIONS: Patients frequently preferred restricting provider access to their EHRs. Providers infrequently overrode patients' preferences to view hidden data. Providers believed that restricting EHR access would adversely impact patient care. Applying Fair Information Practice principles to EHRs will require balancing patient preferences, providers' needs, and health care quality.

The impact of chronic opioid use on colonoscopy outcomes.

BACKGROUND: Endoscopic procedures are frequently performed on patients chronically on opioids, raising concerns about the safety and efficacy of conventional sedation. AIMS: We hypothesized that chronic opioid use is associated with longer procedure times, higher dosages of sedation medications, and an increase in adverse effects. METHODS: This is a retrospective review from June 2012 to June 2013. Patients on chronic opioids (opioids use ≥ 12 weeks) were compared to randomly selected patients matched for age, race, and sex. Multivariate regression analysis was performed to identify factors that were independently predictive of longer procedure times. RESULTS: Patients on chronic opioids required higher doses of fentanyl (122.0 ± 45.3 vs. 105.8 ± 47.2 µg; P < 0.0001) and midazolam (5.3 ± 5.3 vs. 4.4 ± 2 mg; P = 0.0037) and were more likely to receive diphenhydramine (42.8 vs. 22.6 %; P < 0.001). The induction period (11.3 ± 8.8 vs. 7.5 ± 4.0 min), duration of procedure (39.1 ± 17.5 vs. 33.4 ± 14.1 min), and recovery times (38.7 ± 15.3 vs. 33.8 ± 12.1 min) were significantly longer for patients on chronic opioids. In the multivariate regression analysis, opioid use was an independent predictor of longer procedure duration (P < 0.05). Hypotensive episodes did not differ between groups (2.8 vs. 2.7 %; P = 0.8). However, patients on chronic opioids experienced more pain (13.4 vs. 5.9 %; P 0.001) and hypertensive episodes (8.1 vs. 2.8 %; P 0.002). CONCLUSION: Patients on chronic opioids represent a high-risk population with longer procedural times and more discomfort, despite higher dosages of sedative agents. Prospective studies are required to define the risks and benefits of more costly alternative sedation strategies for patients on chronic opioids.

DCLK1 is detectable in plasma of patients with Barrett's esophagus and esophageal adenocarcinoma.

BACKGROUND: Doublecortin-like kinase 1 (DCLK1), a putative tumor stem cell marker has been shown to be highly expressed in the stromal and epithelial compartments in colon and pancreatic cancer as well as Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC). AIM: To prospectively investigate whether the immunohistochemical expression of DCLK1 was associated with detectable DCLK1 plasma expression in patients with existing BE and EAC. METHODS: Immunohistochemistry was performed on paraffin-embedded sections using DCLK1 antibody and scored based on staining intensity and tissue involvement. Purified human plasma samples were subjected to Western blot and ELISA analysis. RESULTS: Forty (40) patients were enrolled: 10 controls (normal endoscopy) and 30 with BE/EAC (13 nondysplastic BE [NDBE], 9 dysplastic BE [DBE] and 8 EAC). Mean epithelial DCLK1 staining was as follows: controls = 0.11, NDBE = 3.83, DBE = 6.0, EAC = 7.17. Mean stromal DCLK1 staining was as follows: NDBE = 5.83, DBE = 5.375, EAC = 10.83. DCLK1 was detected by plasma Western blot in 1 control and in all patients with BE/EAC p < 0.0005. Plasma DCLK1 was elevated by ELISA in EAC compared to other groups, p < 0.05. CONCLUSIONS: Increased expression of DCLK1 was observed in the epithelium, stroma and plasma of patients with BE/EAC. Furthermore, the presence of detectable DCLK1 in plasma of BE/EAC patients may provide a less invasive, detection tool in those patients as well as represent a novel molecular marker distinguishing between normal esophageal mucosa and BE or EAC.

Effect of hyoscine N-butylbromide on adenoma detection rate: meta-analysis of randomized clinical trials.

BACKGROUND AND AIM: Anti-spasmodic drugs may facilitate mucosal inspection during colonoscopy. The impact of hyoscine N-butylbromide (HBB) on polyp detection rate (PDR) and adenoma detection rate (ADR) is unclear. METHODS: We conducted a reproducible literature search of multiple databases. Two reviewers independently compared manuscripts for PDR, ADR, advanced adenoma detection rate (AADR), and rates of complications. Pooling was conducted by fixed-effects and random-effects models. Relative risk (RR) estimates were calculated (95% confidence interval). I(2) index assessed heterogeneity. RESULTS: Patient demographics were comparable. The pooled analysis showed a trend toward improving PDR and ADR among the HBB group compared with the placebo group but failed to reach statistical significance, (46% vs 43%, RR = 1.08 [0.94, 1.25], P = 0.27), (31% vs 28%, RR = 1.12 [0.97, 1.29], P = 0.11) respectively. CONCLUSION: HBB during colonoscopy may provide marginal improvements in ADR and PDR. However, heterogeneity in the available data precludes firm conclusions at this time.