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Judith White;
Kathleen L. Withers;
Mauro Lencioni;
Grace Carolan-Rees;
Antony R. Wilkes;
Kathryn Wood;
Hammah Patrick;
David Cunningham;
Michael Griffith
Purpose: To formally test and validate a patient-reported outcome measure (PROM) for patients with cardiac arrhythmias undergoing catheter ablation procedures in the UK [Cardiff Cardiac Ablation PROM (C-CAP)]. Methods: A multicentre, prospective, observational cohort study with consecutive patient enrolment from three UK sites was conducted. Patients were sent C-CAP questionnaires before and after an ablation procedure. Pre-ablation C-CAP1 (17 items) comprised four domains: patient expectations; condition and symptoms; restricted activity and healthcare visits; medication and general health. Post-ablation C-CAP2 (19 items) comprised five domains including change in symptoms and procedural complications. Both questionnaires also included the generic EQ-5D-5L tool (EuroQol). Reliability, validity, and responsiveness measures were calculated. Results: A total of 517 valid pre-ablation and 434 post-ablation responses were received; questionnaires showed good feasibility and item acceptability. Internal consistency was good (Cronbach’s alpha > 0.7) and test–retest reliability was acceptable for all scales. C-CAP scales showed high responsiveness (effect size > 0.8). Patients improved significantly (p < 0.001) following ablation across all disease-specific and global scales. Minimal clinically important difference was calculated. Improvement beyond the smallest detectable change of 9 points (symptom severi ty scale), 3 points (frequency and duration of symptoms scale), and 8 points (impact on life scale) indicates an important change. Amendments to the C-CAP questionnaires were identified through the validation process and made to produce the final tools. Conclusions: The final C-CAP questionnaires are valid, reliable, and responsive tools for measuring symptom change, impact, and expectations in patients undergoing ablation for cardiac arrhythmias. C-CAP questionnaires provide a tool with disease-specific and generic domains to explore how cardiac ablation procedures in the UK impact upon patients’ lives.
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Natoshia R. Cunningham;
Susmita Kashikar-Zuck;
Constance Mara;
Kenneth R. Goldschneider;
Dennis A. Revicki;
Carlton D Dampier;
David D. Sherry;
Lori Crosby;
Adam Carle;
Karon F. Cook;
Esi M. Morgan
Pain behaviors are important indicators of functioning in chronic pain; however, no self-reported pain behavior instrument has been developed for pediatric populations. The purpose of this study was to create a brief pediatric measure of patient-reported pain behaviors as part of the Patient-Reported Outcome Measurement Information System (PROMIS). A pool of 47 candidate items for this measure had been previously developed through qualitative research. In this study, youth with chronic pain associated with juvenile fibromyalgia, juvenile idiopathic arthritis, or sickle cell disease (ages 8-18 years) from 3 pediatric centers completed all 47 candidate items for development of the pain behavior item bank along with established measures of pain interference, depressive symptoms, fatigue, average pain intensity, and pain catastrophizing. Caregivers reported on sociodemographic information and health history. Psychometric properties of the pain behavior items were examined using an item response theory framework with confirmatory factor analysis and examination of differential item functioning, internal consistency, and test information curves. Results were used along with expert consensus and alignment with the adult PROMIS pain behavior items to arrive at an 8-item pediatric pain behavior short form, and all 47 items were retained in a calibrated item bank. Confirmatory factor analysis and correlations with validated measures of pain, pain interference, and psychosocial functioning provided support for the short form's reliability and validity. The new PROMIS pediatric pain behavior scale provides a reliable, precise, and valid measure for future research on pain behavior in school-aged children with chronic pain.
Introduction Rapid growth of the older adult population requires greater epidemiologic characterization of dementia. We developed national prevalence estimates of diagnosed dementia and subtypes in the highest risk United States (US) population. Methods We analyzed Centers for Medicare & Medicaid administrative enrollment and claims data for 100% of Medicare fee-for-service beneficiaries enrolled during 2011–2013 and age ≥68 years as of December 31, 2013 (n = 21.6 million). Results Over 3.1 million (14.4%) beneficiaries had a claim for a service and/or treatment for any dementia subtype. Dementia not otherwise specified was the most common diagnosis (present in 92.9%). The most common subtype was Alzheimer's (43.5%), followed by vascular (14.5%), Lewy body (5.4%), frontotemporal (1.0%), and alcohol induced (0.7%). The prevalence of other types of diagnosed dementia was 0.2%. Discussion This study is the first to document concurrent prevalence of primary dementia subtypes among this US population. The findings can assist in prioritizing dementia research, clinical services, and caregiving resources.
We conducted a mail survey of practicing pediatricians in Georgia to assess their knowledge, attitudes, and behaviors regarding recording patients' environmental histories. Of 477 eligible pediatricians, 266 (55.8%) responded. Fewer than one in five reported having received training in environmental history-taking. Pediatricians reported that they strongly believe in the importance of environmental exposures in children's health, and 53.5% of respondents reported experience with a patient who was seriously affected by an environmental exposure. Pediatricians agreed moderately strongly that environmental history-taking is useful in identifying potentially hazardous exposures and in helping prevent these exposures. Respondents reported low self-efficacy regarding environmental history-taking, discussing environmental exposures with parents, and finding diagnosis and treatment resources related to environmental exposures. The probability of self-reported history-taking varied with the specific exposure, with environmental tobacco smoke and pets most frequently queried and asbestos, mercury, formaldehyde, and radon rarely queried. The pediatricians' preferred information resources include the American Academy of Pediatrics, newsletters, and patient education materials. Pediatricians are highly interested in pediatric environmental health but report low self-efficacy in taking and following up on environmental histories. There is considerable opportunity for training in environmental history-taking and for increasing the frequency with which such histories are taken.
Background/Objectives:The aim of this study is to determine whether vitamin D status is associated with incident urinary incontinence (UI) among community-dwelling older adults.Subjects/Methods:The University of Alabama at Birmingham Study of Aging is a prospective cohort study of community-dwelling Medicare enrollees. Standardized assessment of UI was conducted using the validated Incontinence Severity Index. The analysis of 25-hydroxyvitamin D [25(OH)D] levels was performed on stored baseline sera. UI was assessed every 6-12 months for up to 42 months. The analyses included multivariable logistic regression and Cox proportional hazard models.Results:Of 350 participants (175 male, 147 black, mean age 73.6±5.8), 54% (189/350) were vitamin D deficient (25(OH)D <20 ng/ml) and 25% (87/350) were vitamin D insufficient (25(OH)D: 20 ng/ml to <30 ng/ml). Among the 187 subjects with no UI at baseline, 57% (107/187) were vitamin D deficient and 24% (45/187) were vitamin D insufficient. A total of 175 of the 187 subjects had follow-up evaluation for incident UI over 42 months, and incident UI occurred in 37% (65/175). After adjustment, cumulative incident UI at 42 months was associated with baseline vitamin D insufficiency (P=0.03) and demonstrated a trend association with deficiency (P=0.07). There was no association between baseline vitamin D status and the time to incident UI.Conclusions:These preliminary results support an association between vitamin D and incident UI in community-dwelling older adults. Future studies may target specific at-risk groups, such as men with BPH or women with pelvic floor disorders for evaluation of the impact of vitamin D supplementation on urinary symptoms.
by
C. L. Comella;
J.S. Perlmutter;
Hyder Jinnah;
T. A. Waliczek;
A. R. Rosen;
W. R. Galpern;
C. A. Adler;
R. L. Barbano;
Stewart Factor;
C. G. Goetz;
J. Jankovic;
S. G. Reich;
R. L. Rodriguez;
W. L. Severt;
M. Zurowski;
S. H. Fox;
G. T. Stebbins
Introduction: The aim of this study was to test the clinimetric properties of the Comprehensive Cervical Dystonia Rating Scale. This is a modular scale with modifications of the Toronto Western Spasmodic Torticollis Rating Scale (composed of three subscales assessing motor severity, disability, and pain) now referred to as the revised Toronto Western Spasmodic Torticollis Scale-2; a newly developed psychiatric screening instrument; and the Cervical Dystonia Impact Profile-58 as a quality of life measure. Methods: Ten dystonia experts rated subjects with cervical dystonia using the comprehensive scale. Clinimetric techniques assessed each module of the scale for reliability, item correlation, and factor structure. Results: There were 208 cervical dystonia patients (73% women; age, 59±10 years; duration, 15±12 years). Internal consistency of the motor severity subscale was acceptable (Cronbach's alpha=0.57). Item to total correlations showed that elimination of items with low correlations (<0.20) increased alpha to 0.71. Internal consistency estimates for the subscales for disability and pain were 0.88 and 0.95, respectively. The psychiatric screening scale had a Cronbach's alpha of 0.84 and satisfactory item to total correlations. When the subscales of the Toronto Western Spasmodic Torticollis Scale-2 were combined with the psychiatric screening scale, Cronbach's alpha was 0.88, and construct validity assessment demonstrated four rational factors: motor; disability; pain; and psychiatric disorders. The Cervical Dystonia Impact Profile-58 had an alpha of 0.98 and its construction was validated through a confirmatory factor analysis. Conclusions: The modules of the Comprehensive Cervical Dystonia Rating Scale are internally consistent with a logical factor structure.
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Jeanette M. Tetrault;
Janet P. Tate;
E. Jennifer Edelman;
Adam J. Gordon;
Vincent Lo Re;
Joseph K. Lim;
David Rimland;
Joseph Goulet;
Stephen Crystal;
Julie R. Gaither;
Cynthia L. Gibert;
Maria C. Rodriguez-Barradas;
Lynn E. Fiellin;
Kendall Bryant;
Amy C. Justice;
David A. Fiellin
Introduction: Individuals with HIV and hepatitis C (HCV) infection, alcohol use disorder, or who are prescribed potentially hepatotoxic medications may be at increased risk for buprenorphine (BUP) associated hepatotoxicity. Materials and methods: We examined a cohort of HIV-infected and uninfected patients receiving an initial BUP prescription between 2003 and 2012. We compared changes in alanine and aspartate aminotransferases (ALT and AST) and total bilirubin (TB) stratified by HIV status. We identified cases of liver enzyme elevation (LEE), TB elevation (TBE), and conducted chart review to assess for cases of drug induced liver injury (DILI) and death. We examined associations between age, sex, race, HIV-infection, HCV-infection, alcohol use disorder, and prescription of other potentially heptatotoxic medications with the composite endpoint of LEE, TBE, and DILI. Results: Of 666 patients prescribed BUP, 36% were HIV-infected, 98% were male, 60% had RNA-confirmed HCV infection, 50% had a recent diagnosis of alcohol use disorder, and 64% were prescribed other potentially hepatotoxic medications. No clinically significant changes were observed in median ALT, AST and TB and these changes did not differ between HIV-infected and uninfected patients. Compared with uninfected patients, HIV-infected (OR 7.3, 95% CI 2.1–26.1, p = 0.002), HCV-infected (OR 4.9 95% CI 1.6–15.2, p = 0.007) or HIV/HCV co-infected patients (OR 6.9, 95%CI 2.1–22.2, p = 0.001) were more likely to have the composite endpoint of LEE, TB elevation or DILI, in analyses that excluded 60 patients with evidence of pre-existing liver injury. 31 patients had LEE, 14/187 HIV-infected and 17/340 uninfected (p = 0.25); 11 had TBE, including 9/186 HIV-infected and 2/329 uninfected (p = 0.002); 8 experienced DILI, 4/202 HIV-infected and 4/204 uninfected (p = 0.45). There were no significant associations with alcohol use disorder or prescription of other potentially hepatotoxic medications after adjustment for HIV/HCV status. Conclusions: Liver enzymes and TB are rarely elevated in HIV-infected and uninfected patients receiving BUP. Risk of hepatotoxicity was greater in individuals infected with HIV, HCV, or HIV/HCV co-infection, who may benefit from increased monitoring.
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Paula Frew;
Saad Omer;
Kimberly Parker;
Marcus Bolton;
Jay Schamel;
Eve Shapiro;
Lauren Owens;
Diane Saint-Victor;
Sahithi Boggavarapu;
Nikia Braxton;
Matthew Archibald ;
Ameeta Kalokhe;
Takeia Horton;
Christin M Root;
Vincent L Fenimore;
Aaron Anderson
BACKGROUND: Underrepresentation of older-age racial and ethnic minorities in clinical research is a significant barrier to health in the United States, as it impedes medical research advancement of effective preventive and therapeutic strategies. OBJECTIVE: The objective of the study was to develop and test the feasibility of a community-developed faith-based intervention and evaluate its potential to increase the number of older African Americans in clinical research. METHODS: Using a cluster-randomized design, we worked with six matched churches to enroll at least 210 persons. We provided those in the intervention group churches with three educational sessions on the role of clinical trials in addressing health disparity topics, and those in the comparison group completed surveys at the same timepoints. All persons enrolled in the study received ongoing information via newsletters and direct outreach on an array of clinical studies seeking participants. We evaluated the short-, mid-, and longer-term effects of the interventional program on clinical trial-related outcomes (ie, screening and enrollment). RESULTS: From 2012 to 2013, we enrolled a balanced cohort of 221 persons in the program. At a 3-month follow-up, mean intention to seek information about clinical trials was higher than baseline in both treatment (mu=7.5/10; sigma=3.1) and control arms (mu=6.6/10; sigma=3.3), with the difference more pronounced in the treatment arm. The program demonstrated strong retention at 3-month (95.4%, 211/221) and 6-month timepoints (94.1%, 208/221). CONCLUSIONS: The "Dose of Hope" program addressed an unmet need to reach an often overlooked audience of older African Americans who are members of churches and stimulate their interest in clinical trial participation. The program demonstrated its appeal in the delivery of effective messages and information about health disparities, and the role of clinical research in addressing these challenges.