Rhonda Roberts

A double-blind, randomized, controlled, multicenter study to assess the safety and cardiovascular effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure after myocardial infarction.

BACKGROUND We sought to determine the safety and preliminary efficacy of transcatheter intramyocardial administration of myoblasts in patients with heart failure (HF). METHODS MARVEL is a randomized placebo-controlled trial of image-guided, catheter-based intramyocardial injection of placebo or myoblasts (400 or 800 million) in patients with class II to IV HF and ejection fraction <35%. Primary end points were frequency of serious adverse events (safety) and changes in 6-minute walk test and Minnesota Living With HF score (efficacy). Of 330 patients intended for enrollment, 23 were randomized (MARVEL-1) before stopping the study for financial reasons. RESULTS At 6 months, similar numbers of events occurred in each group: 8 (placebo), 7 (low dose), and 8 (high dose), without deaths. Ventricular tachycardia responsive to amiodarone was more frequent in myoblast-treated patients: 1 (placebo), 3 (low dose), and 4 (high dose). A trend toward improvement in functional capacity was noted in myoblast-treated groups (Δ6-minute walk test of -3.6 vs +95.6 vs +85.5 m [placebo vs low dose vs high dose; P = .50]) without significant changes in Minnesota Living With HF scores. CONCLUSIONS In HF patients with chronic postinfarction cardiomyopathy, transcatheter administration of myoblasts in doses of 400 to 800 million cells is feasible and may lead to important clinical benefits. Ventricular tachycardia may be provoked by myoblast injection but appears to be a transient and treatable problem. A large-scale outcome trial of myoblast administration in HF patients with postinfarction cardiomyopathy is feasible and warranted.

Identification of Patients With Stable Chest Pain Deriving Minimal Value From Noninvasive Testing: The PROMISE Minimal-Risk Tool, A Secondary Analysis of a Randomized Clinical Trial

Importance Guidelines recommend noninvasive testing for patients with stable chest pain, although many subsequently have normal test results and no adverse clinical events. Objective To describe a risk tool developed to use only pretest clinical data to identify patients with chest pain with normal coronary arteries and no clinical events during follow-up (minimal-risk cohort). Design, Setting, and Participants This secondary analysis of a randomized, pragmatic comparative effectiveness trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]) includes stable, symptomatic outpatients without known coronary artery disease referred for noninvasive testing at 193 sites in North America. Interventions Patients were randomized to receive coronary computed tomography angiography (CCTA) vs functional testing. Main Outcomes and Measures A low-risk tool was developed and internally validated from July 27, 2010, to September 19, 2013, in 4631 patients receiving CCTA as their initial test, with a median follow-up of 25 months. Logistic regression analysis was used to evaluate pretest variables to determine factors associated with minimal risk using a two-thirds random sample for model derivation (n = 3087) and a one-third sample for testing and validation (n = 1544). The model was then applied to the CCTA and functional testing arms, and test results and event rates were ascertained. Results A total of 1243 of 4631 patients (26.8%) were in the minimal-risk cohort. The final minimal-risk model included 10 clinical variables that together were correlated with normal CCTA results and no clinical events (C statistic = 0.725 for the derivation and validation subsets; 95% CI, 0.705-0.746): younger age; female sex; racial or ethnic minority; no history of hypertension, diabetes, or dyslipidemia; family history of premature coronary artery disease; never smoking; symptoms unrelated to physical or mental stress; and higher high-density lipoprotein cholesterol level. Across the entire PROMISE cohort, this model was associated with the lowest rates of severely abnormal test results (1.3% for CCTA; 5.6% for functional) and cardiovascular death or myocardial infarction (0.5% for a median of 25 months) among patients at the highest probability (10th decile) of minimal risk. Conclusions and Relevance In contemporary practice, more than 25% of patients with stable chest pain referred for noninvasive testing will have normal coronary arteries and no long-term clinical events. A clinical tool using readily available pretest variables discriminates such minimal-risk patients, for whom deferred testing may be considered. Trial Registration clinicaltrials.gov Identifier: NCT01174550

Integrative Medicine Patients Have High Stress, Pain, and Psychological Symptoms

CONTEXT Integrative medicine (IM) is a rapidly growing field whose providers report clinical success in treating significant stress, chronic pain, and depressive and anxiety symptoms. While IM therapies have demonstrated efficacy for numerous medical conditions, IM for psychological symptoms has been slower to gain recognition in the medical community. OBJECTIVE AND DESIGN This large, cross-sectional study is the first of its kind to document the psychosocial profiles of 4182 patients at 9 IM clinics that form the BraveNet Practice-Based Research Network (PBRN). RESULTS IM patients reported higher levels of perceived stress, pain, and depressive symptoms, and lower levels of quality of life compared with national norms. Per provider reports, 60% of patients had at least one of the following: stress (9.3%), fatigue (10.2%), anxiety (7.7%), depression (7.2%), and/or sleep disorders (4.8%). Pain, having both physiological and psychological components, was also included and is the most common condition treated at IM clinics. Those with high stress, psychological conditions, and pain were most frequently treated with acupuncture, IM physician consultation, exercise, chiropractic services, diet/nutrition counseling, and massage. CONCLUSION With baseline information on clinical presentation and service utilization, future PBRN studies can examine promising interventions delivered at the clinic to treat stress and psychological conditions.

CHEER National Study of Chronic Rhinosinusitis Practice Patterns: Disease Comorbidities and Factors Associated with Surgery

Objectives (1) Describe national patterns of chronic rhinosinusitis (CRS) care across academic and community practices. (2) Determine the prevalence of comorbid disorders in CRS patients, including nasal polyposis, allergic rhinitis, asthma, and cystic fibrosis. (3) Identify demographic, clinical, and practice type factors associated with endoscopic sinus surgery (ESS). Study Design Multisite cross-sectional study. Setting Otolaryngology’s national research network CHEER (Creating Healthcare Excellence through Education and Research). Subjects and Methods A total of 17,828 adult patients with CRS were identified, of which 10,434 were seen at community practices (59%, n = 8 sites) and 7394 at academic practices (41%, n = 10 sites). Multivariate logistic regression was used to evaluate the association between demographic, practice type, and clinical factors and the odds of a patient undergoing ESS. Results The average age was 50.4 years; 59.5% of patients were female; and 88.3% were Caucasian. The prevalence of comorbid diseases was as follows: allergic rhinitis (35.1%), nasal polyposis (13.3%), asthma (4.4%), and cystic fibrosis (0.2%). In addition, 24.8% of patients at academic centers underwent ESS, as compared with 12.3% at community sites. In multivariate analyses, nasal polyposis (odds ratio [OR], 4.28), cystic fibrosis (OR, 2.42), and academic site type (OR, 1.86) were associated with ESS (P < .001), while adjusting for other factors. Conclusions We describe practice patterns of CRS care, as well as demographic and clinical factors associated with ESS. This is the first study of practice patterns in CRS utilizing the CHEER network and may be used to guide future research.

Tonsillectomy Bleed Rates across the CHEER Practice Research Network Pursuing Guideline Adherence and Quality Improvement

Objectives (1) Compare postoperative bleeding in the CHEER network (Creating Healthcare Excellence through Education and Research) among age groups, diagnoses, and practice types. (2) Report the incidence of bleeding by individual CHEER practice site based on practice guidelines. Study Design Retrospective data collection database review of the CHEER network based on ICD-9 and CPT codes related to tonsillectomy patients. Setting Multisite practice–based network. Subjects and Methods A total of 8347 subjects underwent tonsillectomy as determined by procedure code within the retrospective data collection database, and 107 had postoperative hemorrhage. These subjects had demographic information and related diagnoses based on the CPT and ICD-9 codes collected. Postoperative ICD-9 and CPT codes were used to identify patients who also had postoperative bleed. Variables included age (<12 vs ≥12 years), diagnoses (infectious vs noninfectious), and practice type (community vs academic). Statistical analysis included multivariate logistic regression variables predictive of postoperative bleeding, with P < .05 considered significant. Results Thirteen sites contributed data to the study (7 academic, 6 community). There was postoperative bleeding for an overall bleed rate of 1.3%. Patients ≥12 years old had a significantly increased bleed rate when compared with the younger group (odds ratio, 5.98; 95% confidence interval: 3.79-9.44; P < .0001). There was no significant difference in bleed rates when practices or diagnoses were compared. Conclusion A site descriptor database built to expedite clinical research can be used for practice assessment and quality improvement. These data were also useful to identify patient risk factors for posttonsillectomy bleed.

Characteristics of Cancer Patients Presenting to an Integrative Medicine Practice-Based Research Network

Objective: To assess psychosocial characteristics, symptoms and reasons for seeking integrative medicine (IM) care in cancer patients presenting to IM clinical practices. Study Design and Methods: A survey of 3940 patients was conducted at 8 IM sites. Patient reported outcome measures were collected and clinicians provided health status data. This analysis compares 353 participants self-identified as cancer patients with the larger noncancer cohort. Results: Mean age of the cancer cohort was 55.0 years. Participants were predominantly white (85.9%), female (76.4%), and well educated (80.5% completed college). For 15.2% of cancer patients, depression scores were consistent with depressive symptoms, and average scores for perceived stress were higher than normal, but neither were significantly different from noncancer patients. The most prevalent comorbid symptoms were chronic pain (39.8%), fatigue (33.5%), and insomnia (23.3%). In the cancer cohort, perceived stress was significantly associated with depression, fatigue, insomnia, pain, and QOL. Cancer patients who chose an IM clinical practice “seeking healthcare settings that address spirituality as an aspect of care” had significantly higher levels of perceived stress, depression, and pain than those not selecting this reason. Conclusions: Demographic characteristics, depression scores, perceived stress scores, and reasons for seeking integrative cancer care were not significantly different between cancer patients and noncancer patients. Perceived stress may be an important indicator of QOL. The association of perceived stress, depression and pain with seeking spirituality suggests that providing IM interventions, such as effective stress management techniques and pastoral or spiritual counseling, may be helpful to patients living with cancer.

Perceived Stress in Patients with Common Gastrointestinal Disorders: Associations with Quality of Life, Symptoms and Disease Management

Objective and Methods: Research supports relationships between stress and gastrointestinal (GI) symptoms and disorders. This pilot study assesses relationships between perceived stress, quality of life (QOL), and self‐reported pain ratings as an indicator of symptom management in patients who self‐reported gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD). Results: In the full sample (n = 402) perceived stress positively correlated with depression (r = 0.76, P < .0001), fatigue (r = 0.38, P < .0001), sleep disturbance (r = 0.40, P < .0001), average pain (r = 0.26, P < .0001), and worst pain (r = 0.25, P < .0001). Higher perceived stress also correlated with lower mental health–related QOL. Similar correlations were found for the participants with GERD (n = 188), IBS (n = 132), and IBD (n = 82). Finally, there were significant correlations in the GERD cohort between perceived stress, and average pain (r = 0.34, P < .0001) and worst pain (r = 0.29, P < .0001), and in the IBD cohort between perceived stress, and average pain (r = 0.32, P < .0001), and worst pain (r = 0.35, P < .01). Conclusions: Perceived stress broadly correlated with QOL characteristics in patients with GERD, IBS, and IBD, and their overall QOL was significantly lower than the general population. Perceived stress also appeared to be an indicator of symptom management (self‐reported pain ratings) in GERD and IBD, but not IBS. While future research using objective measures of stress and symptom/disease management is needed to confirm these associations, as well as to evaluate the ability of stress reduction interventions to improve perceived stress, QOL and disease management in these GI disorders, integrative medicine treatment programs would be most beneficial to study.

Variation in the Use of Vestibular Diagnostic Testing for Patients Presenting to Otolaryngology Clinics with Dizziness

Objective We used a national otolaryngology practice–based research network database to characterize the utilization of vestibular function testing in patients diagnosed with dizziness and/or a vestibular disorder. Study Design Database review. Setting The Creating Healthcare Excellence through Education and Research (CHEER) practice-based research network of academic and community providers Subjects and Methods Dizzy patients in the CHEER retrospective database were identified through ICD-9 codes; vestibular testing procedures were identified with CPT codes. Demographics and procedures per patient were tabulated. Analysis included number and type of vestibular tests ordered, stratified by individual clinic and by practice type (community vs academic). Chi-square tests were performed to assess if the percentage of patients receiving testing was statistically significant across clinics. A logistic regression model was used to examine the association between receipt of testing and being tested on initial visit. Results A total of 12,468 patients diagnosed with dizziness and/or a vestibular disorder were identified from 7 community and 5 academic CHEER network clinics across the country. One-fifth of these patients had at least 1 vestibular function test. The percentage of patients tested varied widely by site, from 3% to 72%; academic clinics were twice as likely to test. Initial visit vestibular testing also varied, from 0% to 96% of dizzy patients, and was 15 times more likely in academic clinics. Conclusion There is significant variation in use and timing of vestibular diagnostic testing across otolaryngology clinics. The CHEER network research database does not contain outcome data. These results illustrate the critical need for research that examines outcomes as related to vestibular testing.

Thyroid Disease and Surgery in CHEER: The Nation's Otolaryngology-Head and Neck Surgery Practice-Based Network

Objectives (1) Describe thyroid-related diagnoses and procedures in Creating Healthcare Excellence through Education and Research (CHEER) across academic and community sites. (2) Compare management of malignant thyroid disease across these sites. (3) Provide practice-based data related to flexible laryngoscopy vocal fold assessment before and after thyroid surgery based on the American Academy of Otolaryngology—Head and Neck Surgery Foundation’s clinical practice guidelines. Study Design Review of retrospective data collection (RDC) database of the CHEER network using ICD-9 and CPT codes related to thyroid conditions. Setting Multisite practice-based network. Subjects and Methods There were 3807 thyroid patients (1392 malignant, 2415 benign) with 10,160 unique visits identified from 1 year of patient data in the RDC. Analysis was performed for identified cohort of patients using demographics, site characteristics, and diagnostic and procedural distribution. Results Mean number of patients with thyroid disease per site was 238 (range, 23-715). In community practices, 19% of patients with thyroid disease had cancer versus 45% in the academic setting (P < .001). While academic sites manage more cancer patients, community sites are also surgically treating thyroid cancer and performed more procedures per cancer patient (4.2 vs 3.5, P < .001). Vocal fold function was assessed by flexible laryngoscopy in 34.0% of preoperative patients and in 3.7% postoperatively. Conclusion This is the first overview of malignant and benign thyroid disease through CHEER. It shows how the RDC can be used alone and with national guidelines to inform of clinical practice patterns in academic and community sites. This demonstrates the potential for future thyroid-related studies utilizing the otolaryngology–head and neck surgery practice-based research network.

Burden of Hearing Loss on Communication Partners and Its Influence on Pursuit of Hearing Evaluation

Objective: Describe how the burden on the communication partner (CP) from the patient’s hearing loss, as perceived by both the patient and their CP, influences a patient’s pursuit of hearing evaluation. Design: Cross-sectional design. Demographics, perception of patient’s hearing loss, and associated burden on the CP were collected from both patient and CP via online questionnaires. Patients and their CPs from Duke University Medical Center Otolaryngology Clinic, 55 to 75 years of age, being seen for any reason, who indicated a CP has expressed concern about their hearing. Final sample was 245 matched pairs. Results: Based on completed questionnaires, on average, patients perceived their own hearing loss as more burdensome to the CP than the CP did. However, CPs of patients who believed themselves to have no hearing handicap scored the patient’s hearing loss 54.3% higher than the patient. The patient’s perspective about the amount of burden their hearing loss placed on the CP predicted patients seeking a hearing evaluation. Conclusions: Recognition of early stage hearing loss and associated burden on CPs may be delayed in patients; CPs may help elucidate unrecognized concerns. Educational approaches that raise awareness of burden of hearing loss on CPs along with hearing loss indications could be a feasible, multidimensional strategy to promote help seeking behaviors.