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Article ; Online: Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder

Samuel C. Peter / James G. Murphy / Katie Witkiewitz / Sarah B. Hand / Fridtjof Thomas / Karen Chandler Johnson / Ronald Cowan / Matt Harris / Karen J. Derefinko

Trials, Vol 24, Iss 1, Pp 1-

2023 Volume 15

Abstract: Abstract Background Buprenorphine-naloxone is a medication shown to improve outcomes for individuals seeking treatment for opioid use disorder (OUD); however, outcomes are limited by low medication adherence rates. This is especially true during the ... ...

Abstract	Abstract Background Buprenorphine-naloxone is a medication shown to improve outcomes for individuals seeking treatment for opioid use disorder (OUD); however, outcomes are limited by low medication adherence rates. This is especially true during the early stages of treatment. Methods The present study proposes to utilize a sequential multiple assignment randomized trial design to compare two psychological interventions targeting buprenorphine-naloxone adherence: (1) contingency management (CM) and (2) brief motivational interviewing plus substance-free activities session plus mindfulness (BSM). Participants will be N = 280 adults who present to a university-based addictions clinic seeking treatment for OUD. Participants will be randomized to condition to receive 4 sessions of their assigned intervention (CM or BSM). Participants who are adherent, defined as attending physician appointments and having buprenorphine present in urine toxicology, will enter maintenance intervention for an additional 6 months. Those who are not adherent will be re-randomized to receive either the other intervention or both interventions. Follow-up will occur at 8 months post-randomization. Conclusions This novel design will examine the benefit of sequential treatment decisions following non-adherence. The primary outcome of this study is buprenorphine-naloxone medication adherence, as assessed by physician visit attendance and presence of buprenorphine in urine. Results will elicit the relative efficacy of CM and BSM compared to one another and whether keeping the initial treatment approach when adding the alternative approach for initially non-adherent individuals is beneficial. Trial registration ClinicalTrials.gov NCT04080180
Keywords	Behavioral economics ; Contingency management ; Substance-free activities ; Brief motivational intervention ; Opioid use disorder ; Sequential Multiple Assignment Randomized Trial ; Medicine (General) ; R5-920
Subject code	150
Language	English
Publishing date	2023-03-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Loss of cerebellar function selectively affects intrinsic rhythmicity of eupneic breathing

Yu Liu / Shuhua Qi / Fridtjof Thomas / Brittany L. Correia / Angela P. Taylor / Roy V. Sillitoe / Detlef H. Heck

Biology Open, Vol 9, Iss

2020 Volume 4

Abstract: Respiration is controlled by central pattern generating circuits in the brain stem, whose activity can be modulated by inputs from other brain areas to adapt respiration to autonomic and behavioral demands. The cerebellum is known to be part of the ... ...

Abstract	Respiration is controlled by central pattern generating circuits in the brain stem, whose activity can be modulated by inputs from other brain areas to adapt respiration to autonomic and behavioral demands. The cerebellum is known to be part of the neuronal circuitry activated during respiratory challenges, such as hunger for air, but has not been found to be involved in the control of spontaneous, unobstructed breathing (eupnea). Here we applied a measure of intrinsic rhythmicity, the CV2, which evaluates the similarity of subsequent intervals and is thus sensitive to changes in rhythmicity at the temporal resolution of individual respiratory intervals. The variability of intrinsic respiratory rhythmicity was reduced in a mouse model of cerebellar ataxia compared to their healthy littermates. Irrespective of that difference, the average respiratory rate and the average coefficient of variation (CV) were comparable between healthy and ataxic mice. We argue that these findings are consistent with a proposed role of the cerebellum in modulating the duration of individual respiratory intervals, which could serve the purpose of coordinating respiration with other rhythmic orofacial movements, such as fluid licking and swallowing.
Keywords	respiration ; motor skills disorder ; ataxia ; arrhythmia ; cerebellum ; Science ; Q ; Biology (General) ; QH301-705.5
Language	English
Publishing date	2020-04-01T00:00:00Z
Publisher	The Company of Biologists
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Evidence of chronic kidney disease in veterans with incident diabetes mellitus.

Justin Gatwood / Marie Chisholm-Burns / Robert Davis / Fridtjof Thomas / Praveen Potukuchi / Adriana Hung / Csaba P Kovesdy

PLoS ONE, Vol 13, Iss 2, p e

2018 Volume 0192712

Abstract: While chronic kidney disease (CKD) is regularly evaluated among patients with diabetes, kidney function may be significantly impaired before diabetes is diagnosed. Moreover, disparities in the severity of CKD in such a population are likely. This study ... ...

Abstract	While chronic kidney disease (CKD) is regularly evaluated among patients with diabetes, kidney function may be significantly impaired before diabetes is diagnosed. Moreover, disparities in the severity of CKD in such a population are likely. This study evaluated the extent of CKD in a national cohort of 36,764 US veterans first diagnosed with diabetes between 2003 and 2013 and prior to initiating oral antidiabetic therapy. Evidence of CKD (any stage) at the time of diabetes diagnosis was determined using eGFR and urine-albumin-creatinine ratios, the odds of which were assessed using logistic regression controlling for patient characteristics. CKD was evident in 31.6% of veterans prior to being diagnosed with diabetes (age and gender standardized rates: 241.8 per 1,000 adults [overall] and 247.7 per 1,000 adult males), over half of whom had at least moderate kidney disease (stage 3 or higher). The odds of CKD tended to increase with age (OR: 1.88; 95% CI: 1.82-1.93), hemoglobin A1C (OR: 1.05; 95% CI: 1.04-1.06), systolic blood pressure (OR: 1.04; 95% CI: 1.027-1.043), and BMI (OR: 1.016; 95% CI: 1.011-1.020). Both Asian Americans (OR: 1.53; 95% CI: 1.15-2.04) and African Americans (OR: 1.11; 95% CI: 1.03-1.20) had higher adjusted odds of CKD compared to whites, and prevalence was highest in the Upper Midwest and parts of the Mid-South. Results suggest that evidence of CKD is common among veterans before a diabetes diagnosis, and certain populations throughout the country, such as minorities, may be afflicted at higher rates.
Keywords	Medicine ; R ; Science ; Q
Subject code	616
Language	English
Publishing date	2018-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Impact of pharmacy services on initial clinical outcomes and medication adherence among veterans with uncontrolled diabetes

Justin D. Gatwood / Marie Chisholm-Burns / Robert Davis / Fridtjof Thomas / Praveen Potukuchi / Adriana Hung / M. Shawn McFarland / Csaba P. Kovesdy

BMC Health Services Research, Vol 18, Iss 1, Pp 1-

2018 Volume 9

Abstract: Abstract Background Diabetes remains a growing public health threat but evidence supports the role that pharmacists can play in improving diabetes medication use and outcomes. To improve the quality of care, the Veterans Health Administration has widely ... ...

Abstract	Abstract Background Diabetes remains a growing public health threat but evidence supports the role that pharmacists can play in improving diabetes medication use and outcomes. To improve the quality of care, the Veterans Health Administration has widely adopted care models that integrate clinical pharmacists, but more data are needed to interpret the impact of these services. Our objective was to assess clinical pharmacy services’ impact on outcomes and oral antidiabetic medication (OAD) use among veterans with uncontrolled diabetes in the first year of therapy. Methods This was a retrospective cohort analysis using the Veterans Affairs (VA) Corporate Data Warehouse to identify the first diagnosis of and initiation of OAD therapy for uncomplicated, uncontrolled diabetes (A1C > 7.0%) during 2002–2014. Receipt of clinical pharmacy services was identified using codes within VA electronic health records, and clinical values were obtained at or near the initial fill date and 365 days later. Use of OADs was assessed by proportion of days covered (PDC) for one year following the first filled prescription. Veterans having received clinical pharmacy services were matched 1:1 to those having not seen a clinical pharmacist in the first year of therapy, and generalized linear models assessed changes and differences in outcomes. Results The analysis included 5749 patients in each cohort. On average, patients saw a clinical pharmacist 2.5 times throughout the first year of OAD therapy. Adherence to OAD medications was higher in veterans having seen a pharmacist (84.3% vs. 82.4%, p < 0.0001) and more such patients achieved a PDC of at least 80% (72.2% vs. 68.2%, p < 0.0001). After one year of OAD therapy, mean change in hemoglobin A1C was greater among those receiving pharmacy services (− 1.5% vs. -1.4%, p < 0.0001). Conclusion Pharmacist participation in diabetes patients’ primary care positively affects the multifaceted needs of patients with this condition and comorbid chronic disease.
Keywords	Adherence ; Veterans ; Diabetes ; Disease management ; Pharmacy services ; Public aspects of medicine ; RA1-1270
Subject code	610
Language	English
Publishing date	2018-11-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A web-based tool to predict acute kidney injury in patients with ST-elevation myocardial infarction

Benjamin R Zambetti / Fridtjof Thomas / Inyong Hwang / Allen C Brown / Mason Chumpia / Robert T Ellis / Darshan Naik / Rami N Khouzam / Uzoma N Ibebuogu / Guy L Reed

PLoS ONE, Vol 12, Iss 7, p e

Development, internal validation and comparison.

2017 Volume 0181658

Abstract: In ST-elevation myocardial infarction (STEMI), acute kidney injury (AKI) may increase subsequent morbidity and mortality. Still, it remains difficult to predict AKI risk in these patients. We sought to 1) determine the frequency and clinical outcomes of ... ...

Abstract	In ST-elevation myocardial infarction (STEMI), acute kidney injury (AKI) may increase subsequent morbidity and mortality. Still, it remains difficult to predict AKI risk in these patients. We sought to 1) determine the frequency and clinical outcomes of AKI and, 2) develop, validate and compare a web-based tool for predicting AKI.In a racially diverse series of 1144 consecutive STEMI patients, Stage 1 or greater AKI occurred in 12.9% and was severe (Stage 2-3) in 2.9%. AKI was associated with increased mortality (5.7-fold, unadjusted) and hospital stay (2.5-fold). AKI was associated with systolic dysfunction, increased left ventricular end-diastolic pressures, hypotension and intra-aortic balloon counterpulsation. A computational algorithm (UT-AKI) was derived and internally validated. It showed higher sensitivity and improved overall prediction for AKI (area under the curve 0.76) vs. other published indices. Higher UT-AKI scores were associated with more severe AKI, longer hospital stay and greater hospital mortality.In a large, racially diverse cohort of STEMI patients, Stage 1 or greater AKI was relatively common and was associated with significant morbidity and mortality. A web-accessible, internally validated tool was developed with improved overall value for predicting AKI. By identifying patients at increased risk, this tool may help physicians tailor post-procedural diagnostic and therapeutic strategies after STEMI to reduce AKI and its associated morbidity and mortality.
Keywords	Medicine ; R ; Science ; Q
Subject code	610 ; 616
Language	English
Publishing date	2017-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Expression levels of obesity-related genes are associated with weight change in kidney transplant recipients.

Ann Cashion / Ansley Stanfill / Fridtjof Thomas / Lijing Xu / Thomas Sutter / James Eason / Mang Ensell / Ramin Homayouni

PLoS ONE, Vol 8, Iss 3, p e

2013 Volume 59962

Abstract: The aim of this study was to investigate the association of gene expression profiles in subcutaneous adipose tissue with weight change in kidney transplant recipients and to gain insights into the underlying mechanisms of weight gain.A secondary data ... ...

Abstract	The aim of this study was to investigate the association of gene expression profiles in subcutaneous adipose tissue with weight change in kidney transplant recipients and to gain insights into the underlying mechanisms of weight gain.A secondary data analysis was done on a subgroup (n = 26) of existing clinical and gene expression data from a larger prospective longitudinal study examining factors contributing to weight gain in transplant recipients. Measurements taken included adipose tissue gene expression profiles at time of transplant, baseline and six-month weight, and demographic data. Using multivariate linear regression analysis controlled for race and gender, expression levels of 1553 genes were significantly (p<0.05) associated with weight change. Functional analysis using Gene Ontology and Kyoto Encyclopedia of Genes and Genomes classifications identified metabolic pathways that were enriched in this dataset. Furthermore, GeneIndexer literature mining analysis identified a subset of genes that are highly associated with obesity in the literature and Ingenuity pathway analysis revealed several significant gene networks associated with metabolism and endocrine function. Polymorphisms in several of these genes have previously been linked to obesity.We have successfully identified a set of molecular pathways that taken together may provide insights into the mechanisms of weight gain in kidney transplant recipients. Future work will be done to determine how these pathways may contribute to weight gain.
Keywords	Medicine ; R ; Science ; Q
Subject code	570 ; 616
Language	English
Publishing date	2013-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The recruitment experience of a randomized clinical trial to aid young adult smokers to stop smoking without weight gain with interactive technology

Mace Coday / Phyllis Richey / Fridtjof Thomas / Quynh T. Tran / Sarah B. Terrell / Fran Tylavsky / Danielle Miro / Margaret Caufield / Karen C. Johnson

Contemporary Clinical Trials Communications, Vol 2, Iss C, Pp 61-

2016 Volume 68

Abstract: Multiple recruitment strategies are often needed to recruit an adequate number of participants, especially hard to reach groups. Technology-based recruitment methods hold promise as a more robust form of reaching and enrolling historically hard to reach ... ...

Abstract	Multiple recruitment strategies are often needed to recruit an adequate number of participants, especially hard to reach groups. Technology-based recruitment methods hold promise as a more robust form of reaching and enrolling historically hard to reach young adults. The TARGIT study is a randomized two-arm clinical trial in young adults using interactive technology testing an efficacious proactive telephone Quitline versus the Quitline plus a behavioral weight management intervention focusing on smoking cessation and weight change. All randomized participants in the TARGIT study were required to be a young adult smoker (18–35 years), who reported smoking at least 10 cigarettes per day, had a BMI < 40 kg/m2, and were willing to stop smoking and not gain weight. Traditional recruitment methods were compared to technology-based strategies using standard descriptive statistics based on counts and proportions to describe the recruitment process from initial pre-screening (PS) to randomization into TARGIT. Participants at PS were majority Black (59.80%), female (52.66%), normal or over weight (combined 62.42%), 29.5 years old, and smoked 18.4 cigarettes per day. There were differences in men and women with respect to reasons for ineligibility during PS (p < 0.001; ignoring gender specific pregnancy-related ineligibility). TARGIT experienced a disproportionate loss of minorities during recruitment as well as a prolonged recruitment period due to either study ineligibility or not completing screening activities. Recruitment into longer term behavioral change intervention trials can be challenging and multiple methods are often required to recruit hard to reach groups. ClinicalTrials.gov Identifier NCT01199185: The NHLBI funded TARGIT as part of a U01 Cooperative Agreement and as such the study design was approved. They did not have input into the data collection, analysis, or the interpretation of the data or in the writing of this report.
Keywords	Recruitment methods ; Barriers to recruitment ; Minority participation ; Young adult smokers ; Preventing post cessation weight gain ; Interactive technology ; Medicine (General) ; R5-920
Language	English
Publishing date	2016-04-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Generalization and dilution of association results from European GWAS in populations of non-European ancestry

PLoS Biology, Vol 11, Iss 9, p e

the PAGE study.

2013 Volume 1001661

Abstract: The vast majority of genome-wide association study (GWAS) findings reported to date are from populations with European Ancestry (EA), and it is not yet clear how broadly the genetic associations described will generalize to populations of diverse ... ...

Abstract	The vast majority of genome-wide association study (GWAS) findings reported to date are from populations with European Ancestry (EA), and it is not yet clear how broadly the genetic associations described will generalize to populations of diverse ancestry. The Population Architecture Using Genomics and Epidemiology (PAGE) study is a consortium of multi-ancestry, population-based studies formed with the objective of refining our understanding of the genetic architecture of common traits emerging from GWAS. In the present analysis of five common diseases and traits, including body mass index, type 2 diabetes, and lipid levels, we compare direction and magnitude of effects for GWAS-identified variants in multiple non-EA populations against EA findings. We demonstrate that, in all populations analyzed, a significant majority of GWAS-identified variants have allelic associations in the same direction as in EA, with none showing a statistically significant effect in the opposite direction, after adjustment for multiple testing. However, 25% of tagSNPs identified in EA GWAS have significantly different effect sizes in at least one non-EA population, and these differential effects were most frequent in African Americans where all differential effects were diluted toward the null. We demonstrate that differential LD between tagSNPs and functional variants within populations contributes significantly to dilute effect sizes in this population. Although most variants identified from GWAS in EA populations generalize to all non-EA populations assessed, genetic models derived from GWAS findings in EA may generate spurious results in non-EA populations due to differential effect sizes. Regardless of the origin of the differential effects, caution should be exercised in applying any genetic risk prediction model based on tagSNPs outside of the ancestry group in which it was derived. Models based directly on functional variation may generalize more robustly, but the identification of functional variants remains challenging.
Keywords	Biology (General) ; QH301-705.5
Subject code	580
Language	English
Publishing date	2013-09-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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