Garth Fuller

Long-term Risk of Acute Diverticulitis Among Patients With Incidental Diverticulosis Found During Colonoscopy

BACKGROUND & AIMS Colonic diverticulosis is the most common finding during routine colonoscopy, and patients often question the significance of these lesions. Guidelines state that these patients have a 10% to 25% lifetime risk of developing acute diverticulitis. However, this value was determined based on limited data, collected before population-based colonoscopy, so the true number of cases of diverticulosis was not known. We measured the long-term risk of acute diverticulitis among patients with confirmed diverticulosis discovered incidentally on colonoscopy. METHODS We performed a retrospective study using administrative and clinical data from the Veterans Affairs Greater Los Angeles Healthcare System, collecting data on patients who underwent colonoscopies from January 1996 through January 2011. We identified patients diagnosed with diverticulosis, determined incidence rates per 1000 patient-years, and analyzed a subgroup of patients with rigorously defined events confirmed by imaging or surgery. We used a Cox proportional hazards model to identify factors associated with the development of diverticulitis. RESULTS We identified 2222 patients with baseline diverticulosis. Over an 11-year follow-up period, 95 patients developed diverticulitis (4.3%; 6 per 1000 patient-years); of these, 23 met the rigorous definition of diverticulitis (1%; 1.5 per 1000 patient-years). The median time-to-event was 7.1 years. Each additional decade of age at time of diagnosis reduced the risk for diverticulitis by 24% (hazard ratio, 0.76; 95% confidence interval, 0.6-0.9). CONCLUSIONS Based on a study of the Veterans Affairs Greater Los Angeles Healthcare System, only about 4% of patients with diverticulosis develop acute diverticulitis, contradicting the common belief that diverticulosis has a high rate of progression. We also found that younger patients have a higher risk of diverticulitis, with risk increasing per year of life. These results can help inform patients with diverticulosis about their risk of developing acute diverticulitis.

Increased Risk for Irritable Bowel Syndrome After Acute Diverticulitis

BACKGROUND & AIMS Individuals with diverticulosis frequently also have irritable bowel syndrome (IBS), but there are no longitudinal data to associate acute diverticulitis with subsequent IBS, functional bowel disorders, or related emotional distress. In patients with postinfectious IBS, gastrointestinal disorders cause long-term symptoms, so we investigated whether diverticulitis might lead to IBS. We compared the incidence of IBS and functional bowel and related affective disorders among patients with diverticulitis. METHODS We performed a retrospective study of patients followed up for an average of 6.3 years at a Veterans Administration medical center. Patients with diverticulitis were identified based on International Classification of Diseases, 9th revision codes, selected for the analysis based on chart review (cases, n = 1102), and matched with patients without diverticulosis (controls, n = 1102). We excluded patients with prior IBS, functional bowel, or mood disorders. We then identified patients who were diagnosed with IBS or functional bowel disorders after the diverticulitis attack, and controls who developed these disorders during the study period. We also collected information on mood disorders, analyzed survival times, and calculated adjusted hazard ratios. RESULTS Cases were 4.7-fold more likely to be diagnosed later with IBS (95% confidence interval [CI], 1.6-14.0; P = .006), 2.4-fold more likely to be diagnosed later with a functional bowel disorder (95% CI, 1.6-3.6; P < .001), and 2.2-fold more likely to develop a mood disorder (CI, 1.4-3.5; P < .001) than controls. CONCLUSIONS Patients with diverticulitis could be at risk for later development of IBS and functional bowel disorders. We propose calling this disorder postdiverticulitis IBS. Diverticulitis appears to predispose patients to long-term gastrointestinal and emotional symptoms after resolution of inflammation; in this way, postdiverticulitis IBS is similar to postinfectious IBS.

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)

Computer-Generated Vs. Physician-Documented History of Present Illness (HPI): Results of a Blinded Comparison

Objectives:Healthcare delivery now mandates shorter visits with higher documentation requirements, undermining the patient–provider interaction. To improve clinic visit efficiency, we developed a patient–provider portal that systematically collects patient symptoms using a computer algorithm called Automated Evaluation of Gastrointestinal Symptoms (AEGIS). AEGIS also automatically “translates” the patient report into a full narrative history of present illness (HPI). We aimed to compare the quality of computer-generated vs. physician-documented HPIs.Methods:We performed a cross-sectional study with a paired sample design among individuals visiting outpatient adult gastrointestinal (GI) clinics for evaluation of active GI symptoms. Participants first underwent usual care and then subsequently completed AEGIS. Each individual thereby had both a physician-documented and a computer-generated HPI. Forty-eight blinded physicians assessed HPI quality across six domains using 5-point scales: (i) overall impression, (ii) thoroughness, (iii) usefulness, (iv) organization, (v) succinctness, and (vi) comprehensibility. We compared HPI scores within patient using a repeated measures model.Results:Seventy-five patients had both computer-generated and physician-documented HPIs. The mean overall impression score for computer-generated HPIs was higher than physician HPIs (3.68 vs. 2.80; P<0.001), even after adjusting for physician and visit type, location, mode of transcription, and demographics. Computer-generated HPIs were also judged more complete (3.70 vs. 2.73; P<0.001), more useful (3.82 vs. 3.04; P<0.001), better organized (3.66 vs. 2.80; P<0.001), more succinct (3.55 vs. 3.17; P<0.001), and more comprehensible (3.66 vs. 2.97; P<0.001).Conclusions:Computer-generated HPIs were of higher overall quality, better organized, and more succinct, comprehensible, complete, and useful compared with HPIs written by physicians during usual care in GI clinics.

Development and validation of a disease-targeted quality of life instrument for chronic diverticular disease: the DV-QOL.

BackgroundColonic diverticular disease is typically conceived as acute diverticulitis attacks surrounded by periods of clinical silence. However, evolving data indicate that many patients have persistent symptoms and diminished health-related quality of life (HRQOL) long after acute attacks. We developed a disease-targeted HRQOL measure for symptomatic uncomplicated diverticular disease (SUDD)—the diverticulitis quality of life (DV-QOL) instrument.MethodsWe conducted a systematic literature review to craft a conceptual model of SUDD HRQOL. This was complemented by three focus groups including 45 SUDD patients. We developed items based on our literature search, focus groups, and cognitive debriefings. We administered the items to SUDD patients with persistent symptoms following a confirmed diverticulitis event. We created scales based on factor analysis and evaluated the scales for reliability and validity.ResultsConcept elicitation revealed a range of illness experiences attributed to SUDD. Coding of 20,490 transcribed words yielded a 52-code network with four primary, condition-related concepts: (1) physical symptoms (e.g., bloating); (2) behaviors (e.g., restrictions); (3) cognitions and concerns (e.g., fear); and (4) impact and consequences (e.g., absenteeism, anxiety). Based on patient language, we developed the 17-item DV-QOL instrument. In a cross-sectional validation sample of 197 patients, DV-QOL discriminated between patients with recent versus distant diverticulitis events and correlated highly with Short Form 36 and hospital anxiety and depression scores.ConclusionsPatients with SUDD attribute a wide range of negative psychological, social, and physical symptoms to their condition, both during and after acute attacks; DV-QOL captures these symptoms in a valid, reliable manner.

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. controls.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.

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 (β-coefficient range, -0.04, 0.04), primary care physician scores (β-coefficient range, -0.01, 0.3), and administrator scores (β-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 physicians 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.

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.

Mo1131 Development and Validation of Prism: A Patient Reported Outcome Measure for GERD Patients Who Are Partial or Non-Responders to PPI Therapy

Background: Most patients with gastro-esophageal reflux disease (GERD) experience relief following treatment with proton pump inhibitors (PPI). As many as 17-44% of patients, however, exhibit partial or non-response to PPI therapy. Self-report of symptoms is fundamental to diagnosing and monitoring treatment response in these patients, yet most extant GERD PRO instruments fail to meet development best-practices as described by the FDA. We therefore sought to develop and validate a PRO instrument for clinical trials involving patients with GERD who are PPI partial-responders. Methods: We conducted a systematic literature review, held patient focus groups, convened an expert panel, and conducted cognitive interviews in order to establish content validity. Eligible participants took PPI therapy for at least 8 weeks, had undergone an upper endoscopy revealing no more than L.A. Classification Grade A esophagitis, and scored at least 8 points on the GerdQ. We used ATLAS.TI software to code focus group transcripts, generating frequencies at the domain, subdomain, and primary code levels. Results informed the construction of a conceptual framework, and guided development of 26 draft items. These items and subsequent revisions were reviewed by two expert panels and debriefed with cognitive interview participants. These efforts resulted in PRISM, a 21-item instrument that underwent psychometric evaluation during a Phase IIB drug trial (Protocol SPD557-206). Results: A diverse sample participated in focus groups (N=38; mean age=50.8; 55%M), saturating the codebook and supporting a preliminary conceptual framework. Following drafting of items, a new sample of patients participated in cognitive interviews for purposes of item revision (N=20; Age=52.6; 55%M). During the trial, an exploratory item assessment (n=104) revealed that all but one of the PRISM items met expectations for internal and external indices. A confirmatory factor analysis (n=220) resulted in a 4-factor model displaying the highest goodness-of-fit scores. All domains had a high inter-item correlation (Cronbachs α>0.8). Test-retest reliability was excellent with intraclass correlation also exceeding 0.8. Evidence for convergent validity was strong, with highly significant (p<.01) correlations between average weekly PRISM scores and severity anchors, and significant (p<.05) correlations with RDQ sub-scales. Three of 4 PRISM sub-scale scores were highly responsive to changes in both self-reported severity and symptom relief. Cumulative distribution functions revealed significant differences between responders and non-responders. Conclusion: PRISM demonstrates strong validity and psychometric properties in a clinical trial setting. Developed in line with FDA guidance on PROs, PRISM represents an new outcome measure for GERD patients with partial or nonresponse to PPI therapy.

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