Cluster-Randomized Comparative Effectiveness Trial of Physician-Directed Clinical Decision Support Versus Patient-Directed Education to Promote Appropriate Use of Opioids for Chronic Pain.

We compared the effectiveness of physician-directed clinical decision support (CDS) administered via electronic health record versus patient-directed education to promote the appropriate use of opioids by conducting a cluster-randomized trial involving 82 primary care physicians and 951 of their patients with chronic pain. Primary outcomes were satisfaction with patient-physician communication consumer assessment of health care providers and system clinician and group survey (CG-CAHPS) and pain interference patient-reported outcomes measurement information system. Secondary outcomes included physical function (patient-reported outcomes measurement information system), depression (PHQ-9), high-risk opioid prescribing (>90 morphine milligram equivalents per day [≥90 mg morphine equivalent/day]), and co-prescription of opioids and benzodiazepines. We used multi-level regression to compare longitudinal difference-in-difference scores between arms. The odds of achieving the maximum CG-CAHPS score were 2.65 times higher in the patient education versus the CDS arm (P = .044; 95% confidence interval [CI] 1.03-6.80). However, baseline CG-CAHPS scores were dissimilar between arms, making these results challenging to interpret definitively. No difference in pain interference was found between groups (Coef = -0.64, 95% CI -2.66 to 1.38). The patient education arm experienced higher odds of Rx ≥ 90 milligrams morphine equivalent/day (odds ratio = 1.63; P = .010; 95% CI 1.13, 2.36). There were no differences between groups in physical function, depression, or co-prescription of opioids and benzodiazepines. These results suggest that patient-directed education may have the potential to improve satisfaction with patient-physician communication, whereas physician-directed CDS via electronic health records may have greater potential to reduce high-risk opioid dosing. More evidence is needed to ascertain the relative cost-effectiveness between strategies. PERSPECTIVE: This article presents the results of a comparative-effectiveness study of 2 broadly used communication strategies to catalyze dialog between patients and primary care physicians around chronic pain. The results add to the decision-making literature and offer insights about the relative benefits of physician-directed versus patient-directed interventions to promote the appropriate use of opioids.

Sex-based differences in remote monitoring of biometric, psychometric and biomarker indices in stable ischemic heart disease.

BACKGROUND: Sex-based differences are crucial to consider in the formulation of a personalized treatment plan. We evaluated sex-based differences in adherence and remotely monitored biometric, psychometric, and biomarker data among patients with stable ischemic heart disease (IHD). METHODS: The Prediction, Risk, and Evaluation of Major Adverse Cardiac Events (PRE-MACE) study evaluated patients with stable IHD over a 12-week period. We collected biometric and sleep data using remote patient monitoring via FitBit and psychometric data from Patient-Reported Outcomes Measurement Information System (PROMIS), Kansas City Cardiomyopathy (KCC) and Seattle Angina Questionnaire-7 (SAQ-7) questionnaires. Serum biomarker levels were collected at the baseline visit. We explored sex-based differences in demographics, adherence to study protocols, biometric data, sleep, psychometric data, and biomarker levels. RESULTS: There were 198 patients enrolled, with mean age 65.5 ± 11 years (± Standard deviation, SD), and 60% were females. Females were less adherent to weekly collection of PROMIS, KCC and SAQ-7 physical limitations questionnaires (all p < 0.05), compared to males. There was no difference in biometric physical activity. There was a statistically significant (p < 0.05) difference in sleep duration between sexes, with females sleeping 6 min longer. However, females reported higher PROMIS sleep disturbance scores (p < 0.001) and poorer psychometric scores overall (p < 0.05). A higher proportion of males had clinically significant elevations of median N-terminal pro-brain natriuretic peptide (p = 0.005) and high-sensitivity cardiac troponin levels (p < 0.001) compared to females. CONCLUSIONS: Among females and males with stable IHD, there are sex-based differences in remote monitoring behavior and data. Females are less adherent to psychometric data collection and report poorer psychometric and sleep quality scores than males. Elevated levels of biomarkers for MACE are more common in males. These findings may improve sex-specific understanding of IHD using remote patient monitoring.

Public Perspectives on Decisions About Emergency Care Seeking for Care Unrelated to COVID-19 During the COVID-19 Pandemic.

Importance: Delaying critical care for treatable conditions owing to fear of contracting COVID-19 in the emergency department (ED) is associated with avoidable morbidity and mortality. Objective: To assess and quantify how people decided whether to present to the ED during the COVID-19 pandemic for care unrelated to COVID-19 using conjoint analysis, a form of trade-off analysis that examines how individuals make complex decisions. Design, Setting, and Participants: This cross-sectional survey study was conducted using a nationwide sample from June 1, 2020, during the initial peak of the COVID-19 pandemic. Included participants were adults aged 18 years or older in the US who self-reported that they had not tested positive for COVID-19. Data were analyzed from July 2020 through May 2021. Exposures: Participants completed a self-administered online survey. Main Outcomes and Measures: Using a choice-based conjoint analysis survey, the relative importance was assessed for the following attributes for individuals in deciding whether to seek ED care for symptoms consistent with myocardial infarction or appendicitis: reduction in chance of dying because of ED treatment, crowdedness of ED with other patients, and chance of contracting COVID-19 in the ED. We also performed latent class analyses using conjoint data to identify distinct segments of the respondent population with similar choice patterns. Logistic regression was then used to explore whether patient sociodemographics and political affiliations were factors associated with decision-making. Results: Among 1981 individuals invited to participate, 933 respondents (47.1%) completed the survey; participants' mean (SD) age was 40.1 (13.0) years, and 491 (52.6%) were women. In latent class analyses, 158 individuals (16.9%) with symptoms of myocardial infarction and 238 individuals (25.5%) with symptoms of appendicitis prioritized avoidance of COVID-19 exposure in the ED (ie, chance of contracting COVID-19 in the ED or crowdedness of ED with other patients) over seeking appropriate care for symptoms. Having a usual source of care was a factor associated with lower odds of prioritizing avoidance of COVID-19 exposure (myocardial infarction scenario: adjusted odds ratio, 0.49 [95% CI, 0.32-0.76]; P = .001; appendicitis scenario: adjusted odds ratio, 0.57 [95% CI, 0.40-0.82]; P = .003), but most sociodemographic factors and political affiliations were not factors associated with decision-making. Conclusions and Relevance: This study found that up to one-quarter of individuals were willing to forgo potentially life-saving ED care to avoid exposure to COVID-19. These findings suggest that health care systems and public health organizations should develop effective communications for patients and the community at large that reassure and encourage timely health care for critical needs during the ongoing COVID-19 pandemic and other scenarios.

Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial.

INTRODUCTION: Chronic pain is highly prevalent and associated with a large burden of illness; there is a pressing need for safe, home-based, non-pharmacological, interventions. Virtual reality (VR) is a digital therapeutic known to be effective for acute pain, but its role in chronic pain is not yet fully elucidated. Here we present a protocol for the National Institute of Health (NIH) Back Pain Consortium (BACPAC) VR trial that evaluates the effectiveness of three forms of VR for patients with chronic lower back pain (cLBP), a highly prevalent form of chronic pain. METHODS AND ANALYSIS: The NIH BACPAC VR trial will randomise 360 patients with cLBP into one of three arms, each administered through a head-mounted display: 1) skills-based VR, a program incorporating principles of cognitive behavioural therapy, mindful meditation and physiological biofeedback therapy using embedded biometric sensors; 2) distraction-based VR, a program using 360-degree immersive videos designed to distract users from pain; and 3) sham VR, a non-immersive program using two-dimensional videos within a VR headset. Research participants will be monitored for 12 weeks using a combination of patient-reported outcomes administered via REDCap (Research Electronic Data Capture), wearable sensor data collected via Fitbit Charge 4 and electronic health record data. The primary outcome will be the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale. Secondary outcomes will include PROMIS Anxiety, PROMIS Sleep Disturbance, opioid prescription data and Pain Catastrophizing Scale Short Form. A subgroup analysis will explore patient level predictors for VR efficacy. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Review Board of Cedars-Sinai Health System in April 2020. The results will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04409353.

Biometric and Psychometric Remote Monitoring and Cardiovascular Risk Biomarkers in Ischemic Heart Disease.

Background Patients with stable ischemic heart disease represent a heterogeneous population at variable risk for major adverse cardiac events (MACE). Because MACE typically occurs outside the hospital, we studied whether biometric and psychometric remote patient monitoring are associated with MACE risk biomarkers. Methods and Results In 198 patients with stable ischemic heart disease (mean age 65±11 years, 60% women), we evaluated baseline measures, including biometric (FitBit 2) and psychometric (acquired via smartphone-administered patient-reported outcomes) remote monitoring, in the PRE-MACE (Prediction, Risk, and Evaluation of Major Adverse Cardiac Events) study. In multivariable adjusted regression analyses, we examined the association of these measures with biomarkers of MACE risk, including NT-proBNP (N-terminal pro-b-type natriuretic peptide), u-hs-cTnI (ultra-high sensitivity cardiac-specific troponin I), and hs-CRP (high-sensitivity C-reactive) protein. Both biometric and psychometric measures were associated with NT-proBNP. Specifically, step count, heart rate, physical activity, global health score, and physical function score were all inversely related, whereas physical limitation score was directly related (P≤0.05 for all). However, only biometric measures (step count and heart rate) were associated with u-hs-cTnI (inversely related, P<0.05), while only the psychometric measures of physical limitation were associated with hs-CRP (directly related, P≤0.05). Conclusions In stable ischemic heart disease patients, remotely monitored measures were associated with MACE risk biomarkers. Both biometric and psychometric measures were related to NT-proBNP. In contrast, biometric measures were uniquely related to u-hs-cTnI, while psychometric indices were uniquely related to hs-CRP. Further investigation could assess the predictive value of these metrics for MACE in ischemic heart disease.

Chronic Constipation in the United States: Results From a Population-Based Survey Assessing Healthcare Seeking and Use of Pharmacotherapy.

OBJECTIVES: Chronic idiopathic constipation (CIC) is characterized by unsatisfactory defecation and difficult or infrequent stools. CIC affects 9%-20% of adults in the United States, and although prevalent, gaps in knowledge remain regarding CIC healthcare seeking and medication use in the community. We recruited a population-based sample to determine the prevalence and predictors of (i) individuals having discussed their constipation symptoms with a healthcare provider and (ii) the use of constipation therapies. METHODS: We recruited a representative sample of Americans aged 18 years or older who had experienced constipation. Those who met the Rome IV criteria for irritable bowel syndrome and opioid-induced constipation were excluded. The survey included questions on constipation severity, healthcare seeking, and the use of constipation medications. We used multivariable regression methods to adjust for confounders. RESULTS: Overall, 4,702 participants had experienced constipation (24.0% met the Rome IV CIC criteria). Among all respondents with previous constipation, 37.6% discussed their symptoms with a clinician (primary care provider 87.6%, gastroenterologist 26.0%, and urgent care/emergency room physician 7.7%). Age, sex, race/ethnicity, marital status, employment status, having a source of usual care, insurance status, comorbidities, locus of control, and constipation severity were associated with seeking care (P < 0.05). Overall, 47.8% of respondents were taking medication to manage their constipation: over-the-counter medication(s) only, 93.5%; prescription medication(s) only, 1.3%; and both over-the-counter medication(s) and prescription medication(s), 5.2%. DISCUSSION: We found that 3 of 5 Americans with constipation have never discussed their symptoms with a healthcare provider. Furthermore, the use of prescription medications for managing constipation symptoms is low because individuals mainly rely on over-the-counter therapies.

A protocol integrating remote patient monitoring patient reported outcomes and cardiovascular biomarkers.

We describe the protocol, design, and methodology of the Prediction, Risk, and Evaluation of Major Adverse Cardiac Events (PRE-MACE) study as a multicomponent remote patient monitoring in cardiology. Using biosensor, biomarkers, and patient-reported outcomes in participants with stable ischemic heart disease, the PRE-MACE study is designed to measure cross-sectional correlations and establish the ability of remote monitoring to predict major adverse cardiovascular event (MACE) biomarkers and incident MACE at baseline and 12-month follow-up. It will further assess the adherence and cost-effectiveness of remote monitoring and blood sampling over the initial months. Despite medication and lifestyle changes, patients with cardiovascular disease can experience MACE due to undertreatment, poor adherence, or failure to recognize clinical or biochemical changes that presage MACE. Identifying patients using remote monitoring to detect MACE forerunners has potential to improve outcomes, avoid MACE, and reduce resource utilization. Data collection will include: (1) continuous remote monitoring using wearable biosensors; (2) biomarker measurements using plasma and at-home micro-sampling blood collection; and (3) patient-reported outcomes to monitor perceived stress, anxiety, depression, and health-related quality of life. Two hundred participants will be followed for 90 days with a subset (n = 80) monitored for 180 days. All participants will be followed up for MACE at 12 months.The PRE-MACE study will utilize remote monitoring with biosensors, biomarkers, and patient-reported outcomes to identify intermediate biomarkers of MACE in patients with stable ischemic heart disease. If shown to be effective, this intervention can be utilized between health visits to predict MACE and reduce financial impact of MACE.

Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial.

OBJECTIVES: Therapeutic virtual reality (VR) has emerged as an effective, drug-free tool for pain management, but there is a lack of randomized, controlled data evaluating its effectiveness in hospitalized patients. We sought to measure the impact of on-demand VR versus "health and wellness" television programming for pain in hospitalized patients. METHODS: We performed a prospective, randomized, comparative effectiveness trial in hospitalized patients with an average pain score of ≥3 out of 10 points. Patients in the experimental group received a library of 21 VR experiences administered using the Samsung Gear Oculus headset; control patients viewed specialized television programming to promote health and wellness. Clinical staff followed usual care; study interventions were not protocolized. The primary outcome was patient-reported pain using a numeric rating scale, as recorded by nursing staff during usual care. Pre- and post-intervention pain scores were compared immediately after initial treatment and after 48- and 72-hours. RESULTS: There were 120 subjects (61 VR; 59 control). The mean within-subject difference in immediate pre- and post-intervention pain scores was larger in the VR group (-1.72 points; SD 3.56) than in the control group (-0.46 points; SD 3.01); this difference was significant in favor of VR (P < .04). When limited to the subgroup of patients with severe baseline pain (≥7 points), the effect of VR was more pronounced vs. control (-3.04, SD 3.75 vs. -0.93, SD 2.16 points; P = .02). In regression analyses adjusting for pre-intervention pain, time, age, gender, and type of pain, VR yielded a .59 (P = .03) and .56 (P = .04) point incremental reduction in pain versus control during the 48- and 72-hour post-intervention periods, respectively. CONCLUSIONS: VR significantly reduces pain versus an active control condition in hospitalized patients. VR is most effective for severe pain. Future trials should evaluate standardized order sets that interpose VR as an early non-drug option for analgesia.

Comparing the Real-World Effectiveness of Competing Colonoscopy Preparations: Results of a Prospective Trial.

OBJECTIVES: National societies provide little guidance regarding which colonoscopy bowel preps are best tolerated and most effective; this reflects a lack of comparative effectiveness studies that directly evaluate the available preps in a "real-world" setting. To address this gap, we conducted a prospective, commercially unfunded comparative effectiveness study of currently available bowel preps and measured their impact on bowel cleansing. METHODS: We included patients aged ≥18 years, who presented for an outpatient colonoscopy at a large medical center serving more than 70 academic and community-based endoscopists who are free to prescribe the bowel prep of their choice. The primary outcome was bowel cleansing quality as measured by the Boston Bowel Preparation Scale. We performed regression models with random effects on the outcomes to adjust for confounding. RESULTS: Approximately 4,339 colonoscopies were performed by 75 endoscopists. Magnesium citrate, MiraLAX with Gatorade, MoviPrep, OsmoPrep, Prepopik/Clenpiq, and Suprep all had significantly higher prep tolerability compared with GoLYTELY (all P < 0.05). For bowel cleansing, Suprep (7.28 ± 1.66; P < 0.001), MoviPrep (7.11 ± 1.62; P = 0.004), and MiraLAX with Gatorade (7.09 ± 1.64; P < 0.001) had higher total Boston Bowel Preparation Scale scores compared with GoLYTELY (6.67 ± 1.87); there were no significant differences among the remaining preps. Split-prep dosing was associated with better cleansing; however, men, opioid and tricyclic antidepressent users, and patients with diabetes and cirrhosis had worse cleansing (all P < 0.05). CONCLUSIONS: In this prospective, real-world comparative effectiveness study of available bowel preps, we found that MiraLAX with Gatorade, MoviPrep, and Suprep were prospectively associated with superior tolerability and bowel cleansing.

Feasibility of Patient-Centric Remote Dried Blood Sampling: The Prediction, Risk, and Evaluation of Major Adverse Cardiac Events (PRE-MACE) Study.

Background: Remote patient monitoring can shift important data collection opportunities to low-cost settings. Here, we evaluate whether the quality of blood-samples taken by patients at home differs from samples taken from the same patients by clinical staff. We examine the effects of socio-demographic and patient reported outcomes (PRO) survey data on remote blood sampling compliance and quality. Methods: Samples were collected both in-clinic by study-staff and remotely by subjects at home. During cataloging the samples were graded for quality. We used chi-squared tests and logistic regressions to examine differences in quality and compliance between samples taken in-clinic versus samples taken by subjects at-home. Results: 64.6% of in-clinic samples and 69.7% of samples collected remotely at home received a Good (compared to Not Good) quality grade (chi2 = 4.91; p =.03). Regression analysis found remote samples had roughly 1.5 times higher odds of being Good quality compared to samples taken in-clinic (p <.001; 95% CI 1.18-2.03). Increased anxiety reduced odds of contributing a Good sample (p =.04; 95% CI.95-1.0). Response rates were significantly higher for in-clinic sampling (95.8% vs 89.8%; p <.001). Conclusion: Blood-samples taken by patients at home using a microsampling device yielded higher quality samples than those taken in-clinic.

Validity of Physician and Administrator Peer Review for Selecting Specialist Narrow Network Participants.

Increasingly, insurers control costs by selectively contracting with high-performing, low-cost providers through "narrow networks." Health care systems are faced with selecting specialists for inclusion in these shared-risk contracts. One approach is to use peer ratings, but it remains uncertain whether physicians can identify which of their peers are quantitatively high-quality, highly efficient care providers. If the results of administrator and physician peer ratings were a reliable stand-in for empirical scores, then they might substitute for the resource- and time-intensive task of quantitative performance ratings. This study examines whether peer ratings correlate with empirical ratings from a multisource, quantitative performance score derived from electronic health record (EHR) data. The authors evaluated 74 specialists' quantitative performance using a composite of metrics derived from EHR data. A single-item survey was administered separately that asked 32 primary care physicians (PCPs) to rate the specialists on their orientation to value-based health care. Bivariate and multivariate relationships were assessed between mean PCP ratings and quantitative performance scores, and logistic regression with receiver operating characteristic curve analysis was employed to evaluate the accuracy of peer review in classifying specialists scoring in the top quartile of quantitative performance. Correlations between PCP ratings and quantitative scores were positive and significant (r = 0.70; P < 0.0001). Multivariable linear regression explained 52% of the variance in quantitative scores. Peer ratings predicted top-quartile performance with an accuracy of 82%. Physician and administrator peer ratings identified top-performing specialists fairly accurately, suggesting that PCPs are well positioned as both stewards and assessors of specialist efficiency and quality.

Differences in Online Consumer Ratings of Health Care Providers Across Medical, Surgical, and Allied Health Specialties: Observational Study of 212,933 Providers.

BACKGROUND: Health care consumers are increasingly using online ratings to select providers, but differences in the distribution of scores across specialties and skew of the data have the potential to mislead consumers about the interpretation of ratings. OBJECTIVE: The objective of our study was to determine whether distributions of consumer ratings differ across specialties and to provide specialty-specific data to assist consumers and clinicians in interpreting ratings. METHODS: We sampled 212,933 health care providers rated on the Healthgrades consumer ratings website, representing 29 medical specialties (n=128,678), 15 surgical specialties (n=72,531), and 6 allied health (nonmedical, nonnursing) professions (n=11,724) in the United States. We created boxplots depicting distributions and tested the normality of overall patient satisfaction scores. We then determined the specialty-specific percentile rank for scores across groupings of specialties and individual specialties. RESULTS: Allied health providers had higher median overall satisfaction scores (4.5, interquartile range [IQR] 4.0-5.0) than physicians in medical specialties (4.0, IQR 3.3-4.5) and surgical specialties (4.2, IQR 3.6-4.6, P<.001). Overall satisfaction scores were highly left skewed (normal between -0.5 and 0.5) for all specialties, but skewness was greatest among allied health providers (-1.23, 95% CI -1.280 to -1.181), followed by surgical (-0.77, 95% CI -0.787 to -0.755) and medical specialties (-0.64, 95% CI -0.648 to -0.628). As a result of the skewness, the percentages of overall satisfaction scores less than 4 were only 23% for allied health, 37% for surgical specialties, and 50% for medical specialties. Percentile ranks for overall satisfaction scores varied across specialties; percentile ranks for scores of 2 (0.7%, 2.9%, 0.8%), 3 (5.8%, 16.6%, 8.1%), 4 (23.0%, 50.3%, 37.3%), and 5 (63.9%, 89.5%, 86.8%) differed for allied health, medical specialties, and surgical specialties, respectively. CONCLUSIONS: Online consumer ratings of health care providers are highly left skewed, fall within narrow ranges, and differ by specialty, which precludes meaningful interpretation by health care consumers. Specialty-specific percentile ranks may help consumers to more meaningfully assess online physician ratings.

Erratum: Author Correction: Economic analysis of implementing virtual reality therapy for pain among hospitalized patients.

[This corrects the article DOI: 10.1038/s41746-018-0026-4.].

Online physician ratings fail to predict actual performance on measures of quality, value, and peer review.

Objective: Patients use online consumer ratings to identify high-performing physicians, but it is unclear if ratings are valid measures of clinical performance. We sought to determine whether online ratings of specialist physicians from 5 platforms predict quality of care, value of care, and peer-assessed physician performance. Materials and Methods: We conducted an observational study of 78 physicians representing 8 medical and surgical specialties. We assessed the association of consumer ratings with specialty-specific performance scores (metrics including adherence to Choosing Wisely measures, 30-day readmissions, length of stay, and adjusted cost of care), primary care physician peer-review scores, and administrator peer-review scores. Results: Across ratings platforms, multivariable models showed no significant association between mean consumer ratings and specialty-specific performance scores (ß-coefficient range, -0.04, 0.04), primary care physician scores (ß-coefficient range, -0.01, 0.3), and administrator scores (ß-coefficient range, -0.2, 0.1). There was no association between ratings and score subdomains addressing quality or value-based care. Among physicians in the lowest quartile of specialty-specific performance scores, only 5%-32% had consumer ratings in the lowest quartile across platforms. Ratings were consistent across platforms; a physician's score on one platform significantly predicted his/her score on another in 5 of 10 comparisons. Discussion: Online ratings of specialist physicians do not predict objective measures of quality of care or peer assessment of clinical performance. Scores are consistent across platforms, suggesting that they jointly measure a latent construct that is unrelated to performance. Conclusion: Online consumer ratings should not be used in isolation to select physicians, given their poor association with clinical performance.

Economic analysis of implementing virtual reality therapy for pain among hospitalized patients.

Virtual reality (VR) has emerged as a novel and effective non-pharmacologic therapy for pain, and there is growing interest to use VR in the acute hospital setting. We sought to explore the cost and effectiveness thresholds VR therapy must meet to be cost-saving as an inpatient pain management program. The result is a framework for hospital administrators to evaluate the return on investment of implementing inpatient VR programs of varying effectiveness and cost. Utilizing decision analysis software, we compared adjuvant VR therapy for pain management vs. usual care among hospitalized patients. In the VR strategy, we analyzed potential cost-savings from reductions in opioid utilization and hospital length of stay (LOS), as well as increased reimbursements from higher patient satisfaction as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. The average overall hospitalization cost-savings per patient for the VR program vs. usual care was $5.39 (95% confidence interval -$11.00 to $156.17). In a probabilistic sensitivity analysis across 1000 hypothetical hospitals of varying size and staffing, VR remained cost-saving in 89.2% of trials. The VR program was cost-saving so long as it reduced LOS by ≥14.6%; the model was not sensitive to differences in opioid use or HCAHPS. We conclude that inpatient VR therapy may be cost-saving for a hospital system primarily if it reduces LOS. In isolation, cost-savings from reductions in opioid utilization and increased HCAHPS-related reimbursements are not sufficient to overcome the costs of VR.

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial.

BACKGROUND: Improvements in software and design and reduction in cost have made virtual reality (VR) a practical tool for immersive, three-dimensional (3D), multisensory experiences that distract patients from painful stimuli. OBJECTIVE: The objective of the study was to measure the impact of a onetime 3D VR intervention versus a two-dimensional (2D) distraction video for pain in hospitalized patients. METHODS: We conducted a comparative cohort study in a large, urban teaching hospital in medical inpatients with an average pain score of ≥3/10 from any cause. Patients with nausea, vomiting, dementia, motion sickness, stroke, seizure, and epilepsy and those placed in isolation were excluded. Patients in the intervention cohort viewed a 3D VR experience designed to reduce pain using the Samsung Gear Oculus VR headset; control patients viewed a high-definition, 2D nature video on a 14-inch bedside screen. Pre- and postintervention pain scores were recorded. Difference-in-difference scores and the proportion achieving a half standard deviation pain response were compared between groups. RESULTS: There were 50 subjects per cohort (N=100). The mean pain reduction in the VR cohort was greater than in controls (-1.3 vs -0.6 points, respectively; P=.008). A total of 35 (65%) patients in the VR cohort achieved a pain response versus 40% of controls (P=.01; number needed to treat=4). No adverse events were reported from VR. CONCLUSIONS: Use of VR in hospitalized patients significantly reduces pain versus a control distraction condition. These results indicate that VR is an effective and safe adjunctive therapy for pain management in the acute inpatient setting; future randomized trials should confirm benefit with different visualizations and exposure periods. TRIAL REGISTRATION: Clinicaltrials.gov NCT02456987; https://clinicaltrials.gov/ct2/show/NCT02456987 (Archived by WebCite at http://www.webcitation.org/6pJ1P644S).

PRISM, a Patient-Reported Outcome Instrument, Accurately Measures Symptom Change in Refractory Gastroesophageal Reflux Disease.

BACKGROUND: Most patients with gastroesophageal reflux disease (GERD) experience relief following treatment with proton pump inhibitors (PPIs) (Vakil et al. in Am J Gastroenterol 101:1900-1920, 2006; Everhart and Ruhl in Gastroenterology 136:376-386, 2009). As many as 17-44% of patients, however, exhibit only partial response to therapy. Most extant GERD patient-reported outcome (PRO) instruments fail to meet development best practices as described by the FDA (Talley and Wiklund in Qual Life Res 14:21-33, 2005; Van Pinxteren et al. in Cochrane Database Syst Rev 18:CD002095, 2004; El-Serag et al. in Aliment Pharmacol Ther 32:720-737, 2010). AIM: To develop and validate a PRO instrument for clinical trials involving patients with GERD who are PPI partial responders. METHODS: We prepared a systematic literature review, held patient focus groups, convened an expert panel, and conducted cognitive interviews to establish content validity. Eligible participants took PPI therapy for at least 8 weeks, had undergone an upper endoscopy, and scored at least 8 points on the GerdQ [6]. Qualitative data guided development of 26 draft items. Items were reviewed by expert panels and debriefed with patients. The resulting 21-item instrument underwent psychometric evaluation during a Phase IIB trial. RESULTS: During the trial, confirmatory factor analysis (n = 220) resulted in a four-factor model displaying the highest goodness of fit. All domains had a high inter-item correlation (Cronbach's α > 0.8). Test-retest reliability and convergent validity were strong, with highly significant (p < 0.01) correlations between average weekly PRISM scores and severity anchors and significant (p < 0.05) correlations with anchor subscales. Cumulative distribution functions revealed significant differences between responders and non-responders. CONCLUSIONS: Analysis in a clinical trial setting demonstrated strong psychometric properties suggesting validity of PRISM. Developed in line with FDA guidance on PROs, PRISM represents an important new outcome measure for patients with GERD with a partial response to PPI therapy.

A Large-Scale Initiative Inviting Patients to Share Personal Fitness Tracker Data with Their Providers: Initial Results.

BACKGROUND: Personal fitness trackers (PFT) have substantial potential to improve healthcare. OBJECTIVE: To quantify and characterize early adopters who shared their PFT data with providers. METHODS: We used bivariate statistics and logistic regression to compare patients who shared any PFT data vs. patients who did not. RESULTS: A patient portal was used to invite 79,953 registered portal users to share their data. Of 66,105 users included in our analysis, 499 (0.8%) uploaded data during an initial 37-day study period. Bivariate and regression analysis showed that early adopters were more likely than non-adopters to be younger, male, white, health system employees, and to have higher BMIs. Neither comorbidities nor utilization predicted adoption. CONCLUSION: Our results demonstrate that patients had little intrinsic desire to share PFT data with their providers, and suggest that patients most at risk for poor health outcomes are least likely to share PFT data. Marketing, incentives, and/or cultural change may be needed to induce such data-sharing.

Impact of National Institutes of Health Gastrointestinal PROMIS Measures in Clinical Practice: Results of a Multicenter Controlled Trial.

OBJECTIVES: The National Institutes of Health (NIH) created the Patient Reported Outcomes Measurement Information System (PROMIS) to allow efficient, online measurement of patient-reported outcomes (PROs), but it remains untested whether PROMIS improves outcomes. Here, we aimed to compare the impact of gastrointestinal (GI) PROMIS measures vs. usual care on patient outcomes. METHODS: We performed a pragmatic clinical trial with an off-on study design alternating weekly between intervention (GI PROMIS) and control arms at one Veterans Affairs and three university-affiliated specialty clinics. Adults with GI symptoms were eligible. Intervention patients completed GI PROMIS symptom questionnaires on an e-portal 1 week before their visit; PROs were available for review by patients and their providers before and during the clinic visit. Usual care patients were managed according to customary practices. Our primary outcome was patient satisfaction as determined by the Consumer Assessment of Healthcare Providers and Systems questionnaire. Secondary outcomes included provider interpersonal skills (Doctors' Interpersonal Skills Questionnaire (DISQ)) and shared decision-making (9-item Shared Decision Making Questionnaire (SDM-Q-9)). RESULTS: There were 217 and 154 patients in the GI PROMIS and control arms, respectively. Patient satisfaction was similar between groups (P>0.05). Intervention patients had similar assessments of their providers' interpersonal skills (DISQ 89.4±11.7 vs. 89.8±16.0, P=0.79) and shared decision-making (SDM-Q-9 79.3±12.4 vs. 79.0±22.0, P=0.85) vs. CONCLUSIONS: This is the first controlled trial examining the impact of NIH PROMIS in clinical practice. One-time use of GI PROMIS did not improve patient satisfaction or assessment of provider interpersonal skills and shared decision-making. Future studies examining how to optimize PROs in clinical practice are encouraged before widespread adoption.

Computer versus physician identification of gastrointestinal alarm features.

OBJECTIVE: It is important for clinicians to inquire about "alarm features" as it may identify those at risk for organic disease and who require additional diagnostic workup. We developed a computer algorithm called Automated Evaluation of Gastrointestinal Symptoms (AEGIS) that systematically collects patient gastrointestinal (GI) symptoms and alarm features, and then "translates" the information into a history of present illness (HPI). Our study's objective was to compare the number of alarms documented by physicians during usual care vs. that collected by AEGIS. METHODS: We performed a cross-sectional study with a paired sample design among patients visiting adult GI clinics. Participants first received usual care by their physicians and then completed AEGIS. Each individual thus contributed both a physician-documented and computer-generated HPI. Blinded physician reviewers enumerated the positive alarm features (hematochezia, melena, hematemesis, unintentional weight loss, decreased appetite, and fevers) mentioned in each HPI. We compared the number of documented alarms within patient using the Wilcoxon signed-rank test. RESULTS: Seventy-five patients had both physician and AEGIS HPIs. AEGIS identified more patients with positive alarm features compared to physicians (53% vs. 27%; p<.001). AEGIS also documented more positive alarms (median 1, interquartile range [IQR] 0-2) vs. physicians (median 0, IQR 0-1; p<.001). Moreover, clinicians documented only 30% of the positive alarms self-reported by patients through AEGIS. CONCLUSIONS: Physicians documented less than one-third of red flags reported by patients through a computer algorithm. These data indicate that physicians may under report alarm features and that computerized "checklists" could complement standard HPIs to bolster clinical care.