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Article ; Online: Protocol for harmonization of randomized trials testing the addition of behavioral therapy to buprenorphine for opioid use disorder.

McHugh, R Kathryn / Bailey, Allen J / Weiss, Roger D / Fitzmaurice, Garrett M

Drug and alcohol dependence reports

2024 Volume 11, Page(s) 100226

Abstract: Background: Although buprenorphine is an effective treatment for opioid use disorder (OUD), much remains to be understood about treatment non-response and methods for improving treatment retention. The addition of behavioral therapies to buprenorphine ... ...

Abstract	Background: Although buprenorphine is an effective treatment for opioid use disorder (OUD), much remains to be understood about treatment non-response and methods for improving treatment retention. The addition of behavioral therapies to buprenorphine has not yielded consistent benefits for opioid outcomes, on average. However, several studies suggest that certain subgroups may benefit from the combination of buprenorphine and behavioral therapy, highlighting the potential for personalized approaches to treatment. Furthermore, little is known about whether behavioral therapies improve buprenorphine retention or non-opioid (e.g., functional) outcomes. Methods: The objective of this project is to harmonize four previously conducted clinical trials testing the addition of behavioral therapy to buprenorphine maintenance for OUD and to use this larger dataset to answer critical clinical questions about the role of behavioral therapy in this population. Study aims include identifying potential moderators of the effect of the addition of behavioral therapy and quantifying the effect of behavioral therapy on buprenorphine retention and functional outcomes. Results: Analyses will consider outcomes of weeks of opioid use, weeks of retention in buprenorphine treatment, and functional outcomes as measured by the Addiction Severity Index. Analyses will include an indicator for each study to account for heterogeneity of samples and design. Conclusion: Results will help to inform clinical and research efforts to optimize the use of behavioral therapies in the treatment of OUD.
Language	English
Publishing date	2024-03-13
Publishing country	Netherlands
Document type	Journal Article
ISSN	2772-7246
ISSN (online)	2772-7246
DOI	10.1016/j.dadr.2024.100226
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Article ; Online: Temporal patterns of suicide and circulatory system disease-related mortality are inversely correlated in several countries.

Kaufman, Marc J / Fitzmaurice, Garrett M

BMC psychiatry

2021 Volume 21, Issue 1, Page(s) 153

Abstract: Background: Nearly 800,000 suicides occur worldwide annually and suicide rates are increasing faster than population growth. Unfortunately, the pathophysiology of suicide remains poorly understood, which has hindered suicide prevention efforts. However, ...

Abstract	Background: Nearly 800,000 suicides occur worldwide annually and suicide rates are increasing faster than population growth. Unfortunately, the pathophysiology of suicide remains poorly understood, which has hindered suicide prevention efforts. However, mechanistic clues may be found by studying effects of seasonality on suicide and other mortality causes. Suicides tend to peak in spring-summer periods and nadir in fall-winter periods while circulatory system disease-related mortality tends to exhibit the opposite temporal trends. This study aimed to determine for the first time whether monthly temporal cross-correlations exist between suicide and circulatory system disease-related mortality at the population level. If so and if common biological factors moderate risks for both mortality types, such factors may be discoverable and utilized to improve suicide prevention. Methods: We conducted time series analyses of monthly mortality data from northern (England and Wales, South Korea, United States) and southern (Australia, Brazil) hemisphere countries during the period 2009-2018 (N = 41.8 million all-cause mortality cases). We used a Poisson regression variant of the standard cosinor model to determine peak months of mortality. We also estimated cross-correlations between monthly mortality counts from suicide and from circulatory system diseases. Results: Suicide and circulatory disease-related mortality temporal patterns were negatively correlated in Australia (- 0.32), Brazil (- 0.57), South Korea (- 0.32), and in the United States (- 0.66), but no temporal correlation was discernable in England and Wales. Conclusions: The negative temporal cross-correlations between these mortality types we found in 4 of 5 countries studied suggest that seasonal factors broadly and inversely moderate risks for circulatory disease-related mortality and suicide, but not in all regions, indicating that the effect is not uniform. Since the seasonal factors of temperature and light exert opposite effects on suicide and circulatory disease-related mortality in several countries, we propose that physiologically-adaptive circulatory system responses to heat and light may increase risk for suicide and should be studied to determine whether they affect suicide risk. For example, heat and light increase production and release of the bioactive gas nitric oxide and reduce circulatory system disease by relaxing blood vessel tone, while elevated nitric oxide levels are associated with suicidal behavior, inverse effects that parallel the inverse temporal mortality patterns we detected.
MeSH term(s)	Australia ; Brazil ; England ; Humans ; Republic of Korea/epidemiology ; Seasons ; Suicide ; United States/epidemiology ; Wales
Language	English
Publishing date	2021-03-16
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ISSN	1471-244X
ISSN (online)	1471-244X
DOI	10.1186/s12888-021-03159-5
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Article ; Online: Permutation Tests for Assessing Potential Non-Linear Associations between Treatment Use and Multivariate Clinical Outcomes.

Ren, Boyu / Lipsitz, Stuart R / Fitzmaurice, Garrett M / Weiss, Roger D

Multivariate behavioral research

2023 Volume 59, Issue 1, Page(s) 110–122

Abstract: In many psychometric applications, the relationship between the mean of an outcome and a quantitative covariate is too complex to be described by simple parametric functions; instead, flexible nonlinear relationships can be incorporated using penalized ... ...

Abstract	In many psychometric applications, the relationship between the mean of an outcome and a quantitative covariate is too complex to be described by simple parametric functions; instead, flexible nonlinear relationships can be incorporated using penalized splines. Penalized splines can be conveniently represented as a linear mixed effects model (LMM), where the coefficients of the spline basis functions are random effects. The LMM representation of penalized splines makes the extension to multivariate outcomes relatively straightforward. In the LMM, no effect of the quantitative covariate on the outcome corresponds to the null hypothesis that a fixed effect and a variance component are both zero. Under the null, the usual asymptotic chi-square distribution of the likelihood ratio test for the variance component does not hold. Therefore, we propose three permutation tests for the likelihood ratio test statistic: one based on permuting the quantitative covariate, the other two based on permuting residuals. We compare
MeSH term(s)	Linear Models ; Computer Simulation ; Likelihood Functions ; Chi-Square Distribution
Language	English
Publishing date	2023-06-28
Publishing country	United States
Document type	Journal Article
ISSN	1532-7906
ISSN (online)	1532-7906
DOI	10.1080/00273171.2023.2217662
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Article ; Online: Multiple imputation for non-monotone missing not at random data using the no self-censoring model.

Ren, Boyu / Lipsitz, Stuart R / Weiss, Roger D / Fitzmaurice, Garrett M

Statistical methods in medical research

2023 Volume 32, Issue 10, Page(s) 1973–1993

Abstract: Although approaches for handling missing data from longitudinal studies are well-developed when the patterns of missingness are monotone, fewer methods are available for non-monotone missingness. Moreover, the conventional missing at random assumption-a ... ...

Abstract	Although approaches for handling missing data from longitudinal studies are well-developed when the patterns of missingness are monotone, fewer methods are available for non-monotone missingness. Moreover, the conventional missing at random assumption-a natural benchmark for monotone missingness-does not model realistic beliefs about the non-monotone missingness processes (Robins and Gill, 1997). This has provided the impetus for alternative non-monotone missing not at random mechanisms. The "no self-censoring" model is such a mechanism and assumes the probability an outcome variable is missing is independent of its value when conditioning on all other possibly missing outcome variables and their missingness indicators. As an alternative to "weighting" methods that become computationally demanding with increasing number of outcome variables, we propose a multiple imputation approach under no self-censoring. We focus on the case of binary outcomes and present results of simulation and asymptotic studies to investigate the performance of the proposed imputation approach. We describe a related approach to sensitivity analysis to departure from no self-censoring. We discuss the relationship between missing at random and no self-censoring and prove that one is not a special case of the other. Finally, we discuss extensions to non-binary data settings. The proposed methods are illustrated with application to a substance use disorder clinical trial.
MeSH term(s)	Models, Statistical ; Computer Simulation ; Longitudinal Studies ; Probability
Language	English
Publishing date	2023-08-30
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1136948-6
ISSN	1477-0334 ; 0962-2802
ISSN (online)	1477-0334
ISSN	0962-2802
DOI	10.1177/09622802231188520
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Zs.A 3564: Show issues

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Article ; Online: Methods for handling missing binary data in substance use disorder trials.

Ren, Boyu / Lipsitz, Stuart R / Weiss, Roger D / Fitzmaurice, Garrett M

Drug and alcohol dependence

2023 Volume 250, Page(s) 110897

Abstract: Missing data are a ubiquitous problem in longitudinal substance use disorder (SUD) clinical trials. In particular, the rates of missingness are often high and study participants often intermittently skip their scheduled outcome assessments, leading to so- ...

Abstract	Missing data are a ubiquitous problem in longitudinal substance use disorder (SUD) clinical trials. In particular, the rates of missingness are often high and study participants often intermittently skip their scheduled outcome assessments, leading to so-called "non-monotone" missing data patterns. Moreover, when the primary outcome is a measure of substance use, study investigators often have strong prior beliefs based on their clinical experience that those participants with missing data are more likely to be using substances at those occasions, i.e., data are missing not at random (MNAR). Although approaches for handling missing data are well-developed when the missing data patterns are monotone, arising primarily from study participants withdrawing from the trial prematurely, fewer methods are available for non-monotone missingness. In this paper we review some conventional, as well as more novel, methods for handling non-monotone missingness in SUD trials when the repeatedly measured outcome variable is binary (e.g., denoting presence/absence of substance use). We compare and contrast the different approaches using data from a longitudinal clinical trial of four psychosocial treatments from the Collaborative Cocaine Treatment Study. We conclude by making some recommendations to the SUD research community concerning how more principled methods for handling missing data can be incorporated in the analysis and reporting of trial results.
MeSH term(s)	Humans ; Models, Statistical ; Longitudinal Studies ; Outcome Assessment, Health Care ; Substance-Related Disorders/therapy ; Research Design
Language	English
Publishing date	2023-07-13
Publishing country	Ireland
Document type	Journal Article ; Review ; Research Support, N.I.H., Extramural
ZDB-ID	519918-9
ISSN	1879-0046 ; 0376-8716
ISSN (online)	1879-0046
ISSN	0376-8716
DOI	10.1016/j.drugalcdep.2023.110897
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Zs.A 1310: Show issues

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Article ; Online: Longitudinal Description and Prediction of Smoking Among Borderline Patients: An 18-Year Follow-Up Study.

Brañas, Marcelo J A A / Frankenburg, Frances R / Temes, Christina M / Fitzmaurice, Garrett M / Zanarini, Mary C

The Journal of clinical psychiatry

2023 Volume 84, Issue 6

Abstract: Objective:: Methods:: Results:: Conclusions: ...

Abstract	Objective: Methods: Results: Conclusions:
MeSH term(s)	Adult ; Humans ; Follow-Up Studies ; Longitudinal Studies ; Tobacco Smoking ; Smoking/epidemiology ; Alcoholism ; Borderline Personality Disorder/diagnosis ; Borderline Personality Disorder/epidemiology ; Borderline Personality Disorder/psychology
Language	English
Publishing date	2023-11-08
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	716287-x
ISSN	1555-2101 ; 0160-6689
ISSN (online)	1555-2101
ISSN	0160-6689
DOI	10.4088/JCP.22m14756
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Zs.B 108: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 247: Show issues

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Article: Impact of pediatric versus adult colonoscope on terminal ileum intubation: a retrospective study.

Alkhatib, Amer A / Fitzmaurice, Garrett M / Kumar, Shiva

Annals of gastroenterology

2022 Volume 35, Issue 2, Page(s) 169–176

Abstract: Background: Various possible predictors of successful terminal ileal intubation (TII) have been explored but the role of the type of colonoscope is unclear.: Methods: We carried out a retrospective review of a prospectively collected database of all ... ...

Abstract	Background: Various possible predictors of successful terminal ileal intubation (TII) have been explored but the role of the type of colonoscope is unclear. Methods: We carried out a retrospective review of a prospectively collected database of all colonoscopies performed at a single endoscopy unit between May 2015 and July 2020. The primary outcome measure was successful TII in patients with specific indications for ileal examination. The primary predictor was the type of endoscope, pediatric or adult, used during the procedure. Univariate and multivariate analyses were performed. Results: In 5845 colonoscopies fulfilling the study criteria, the overall TII rate was 67.8%. In univariate analysis, the use of a pediatric colonoscope was associated with a higher TII rate (72.1% vs. 58.8%, P<0.001). Other variables associated with successful TII based on univariate analysis included the patient's age, male sex, body mass index, endoscopists' specialty, place of training, shorter colonoscope insertion time, shorter duration of the procedure, longer withdrawal time, procedures performed in the afternoon, type of sedation administered during colonoscopy, and cleanliness of the colon. Multivariate analysis yielded an adjusted odds ratio (OR) of 1.40 (95% confidence interval [CI] 1.21-1.62) for the use of a pediatric colonoscope. Propensity score-matching analysis also showed superiority of the pediatric colonoscope in achieving TII compared to an adult colonoscope, OR 1.35 (95%CI 1.17-1.57). Conclusions: Pediatric colonoscope increases the success of TII during colonoscopy. For endoscopists performing colonoscopy with intent to examine the terminal ileum, it is recommended to choose a pediatric colonoscope to maximize the success rate.
Language	English
Publishing date	2022-02-21
Publishing country	Greece
Document type	Journal Article
ZDB-ID	2032850-3
ISSN	1108-7471
ISSN	1108-7471
DOI	10.20524/aog.2022.0700
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Zs.A 2455: Show issues

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Article ; Online: Cognitive behavioral therapy for anxiety and opioid use disorder: Development and pilot testing.

McHugh, R Kathryn / Fitzmaurice, Garrett M / Votaw, Victoria R / Geyer, Rachel B / Ragnini, Kael / Greenfield, Shelly F / Weiss, Roger D

Journal of substance use and addiction treatment

2024 Volume 160, Page(s) 209296

Abstract: Introduction: Anxiety disorders are highly prevalent among people with opioid use disorder (OUD), and they have a negative impact on disorder course and treatment outcomes. The objective of this Stage 1 A/1B behavioral treatment development trial was to ...

Abstract	Introduction: Anxiety disorders are highly prevalent among people with opioid use disorder (OUD), and they have a negative impact on disorder course and treatment outcomes. The objective of this Stage 1 A/1B behavioral treatment development trial was to develop a novel cognitive-behavioral therapy (CBT) protocol for co-occurring anxiety disorders and OUD. Methods: Following a period of iterative manual development involving patient interviews and feedback from content experts, we tested a 12-session individual CBT protocol in a small, open pilot trial (N = 5). This was followed by a small, randomized controlled trial (N = 32), comparing the new protocol to 12 sessions of manualized Individual Drug Counseling. All participants also received medication for OUD. Results: Overall, support for feasibility and acceptability was strong, based on recruitment and retention rates and patient satisfaction ratings. Within-subjects results identified 11-point reductions in anxiety symptom severity (on a 0-56 point scale); these gains were sustained through 3 months of follow-up. However, these changes did not differ between randomized conditions. With respect to opioid outcomes, 85 % of participants were abstinent in the prior month at the end of treatment. Opioid use outcomes also did not differ by treatment condition. Conclusions: These results support the feasibility and acceptability of a CBT protocol for co-occurring anxiety and OUD. However, in this small pilot trial results do not show an initial benefit over an evidence-based psychosocial treatment targeted to OUD alone, in combination with medication for OUD.
MeSH term(s)	Humans ; Cognitive Behavioral Therapy/methods ; Opioid-Related Disorders/psychology ; Opioid-Related Disorders/therapy ; Pilot Projects ; Male ; Adult ; Female ; Anxiety Disorders/therapy ; Middle Aged ; Treatment Outcome ; Feasibility Studies ; Patient Satisfaction
Language	English
Publishing date	2024-01-24
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ISSN	2949-8759
ISSN (online)	2949-8759
DOI	10.1016/j.josat.2024.209296
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Article ; Online: Pathways to Health Reported by Patients With Borderline Personality Disorder With a Good Overall Outcome Versus a Fair-Poor Outcome Over 24 Years of Prospective Follow-Up.

Zanarini, Mary C / Hein, Katherine E / Temes, Christina M / Frankenburg, Frances R / Fitzmaurice, Garrett M

Journal of personality disorders

2023 Volume 37, Issue 4, Page(s) 456–468

Abstract: Our objective was to determine pathways to health reported by patients with borderline personality disorder (BPD) who had and had not attained a good overall outcome over 24 years of prospective follow-up. Overall outcome symptomatically and ... ...

Abstract	Our objective was to determine pathways to health reported by patients with borderline personality disorder (BPD) who had and had not attained a good overall outcome over 24 years of prospective follow-up. Overall outcome symptomatically and psychosocially and 11 pathways to health related to vocation, relationships, activities, and psychiatric treatment that patients reported were helpful to their functioning or feeling better about themselves were assessed at 12 contiguous 2-year follow-up periods using a semistructured interview. Good outcome patients reported significantly higher rates of pathways related to work performance, relationships with friends, relationship with a partner/spouse, and athletic activities. In contrast, patients with a fair-poor outcome reported significantly higher rates of psychotherapy and psychotropic medication as pathways. Taken together, the results of this study suggest that a good overall outcome is significantly associated with reported vocational, interpersonal, and activity pathways, while a fair-poor outcome is significantly associated with reported treatment-related pathways.
MeSH term(s)	Humans ; Borderline Personality Disorder/therapy ; Follow-Up Studies ; Prospective Studies ; Emotions ; Psychotherapy
Language	English
Publishing date	2023-09-18
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	639252-0
ISSN	1943-2763 ; 0885-579X
ISSN (online)	1943-2763
ISSN	0885-579X
DOI	10.1521/pedi.2023.37.4.456
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Zs.A 2287: Show issues

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Book: Applied longitudinal analysis

Fitzmaurice, Garrett M. / Laird, Nan M. / Ware, James H.

(Wiley series in probability and statistics ; A John Wiley & Sons, Inc., publication)

2004

Author's details	Garrett M. Fitzmaurice ; Nan M. Laird ; James H. Ware
Series title	Wiley series in probability and statistics A John Wiley & Sons, Inc., publication
Keywords	Biometry / methods ; Longitudinal Studies ; Regression Analysis ; Multivariate Analysis ; Longitudinal method ; Regression analysis ; Multivariate analysis ; Medical statistics ; Längsschnittuntersuchung ; Ökonometrie
Subject	Ökonometrische Analyse ; Längsschnittanalyse ; Langzeituntersuchung ; Langzeitstudie ; Längsschnittstudie ; Longitudinale Analyse ; Longitudinalstudie ; Longitudinal study ; Longitudinalanalyse ; Longitudinal analysis ; Langzeitforschung
Subject code	519.53
Language	English
Size	XIX, 506 S. : graph. Darst.
Publisher	Wiley-Interscience
Publishing place	Hoboken, NJ
Publishing country	United States
Document type	Book
Note	Ex. mit unterschiedlichen ISBNs
HBZ-ID	HT014259745
ISBN	0-471-21487-6 ; 978-0-471-21487-8
Database	Catalogue ZB MED Medicine, Health

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2005 A 2892	order for loan	Magazin

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