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Article ; Online: Reconsidering stepped wedge cluster randomized trial designs with implementation periods: Fewer sequences or the parallel-group design with baseline and implementation periods are potentially more efficient.

Westgate, Philip M / Nigam, Shawn R / Shoben, Abigail B

2024 , Page(s) 17407745241244790

Abstract: Background/aims: When designing a cluster randomized trial, advantages and disadvantages of tentative designs must be weighed. The stepped wedge design is popular for multiple reasons, including its potential to increase power via improved efficiency ... ...

Abstract	Background/aims: When designing a cluster randomized trial, advantages and disadvantages of tentative designs must be weighed. The stepped wedge design is popular for multiple reasons, including its potential to increase power via improved efficiency relative to a parallel-group design. In many realistic settings, it will take time for clusters to fully implement the intervention. When designing the HEALing (Helping to End Addiction Long-term Methods: We compare efficiencies of stepped wedge designs with implementation periods consisting of three to nine sequences with a variety of corresponding designs. The three-sequence design is compared to the two-sequence modified design and to the parallel-group design with baseline and implementation periods analysed via analysis of covariance. Stepped wedge designs with implementation periods consisting of four or more sequences are compared to modified designs that remove all or a subset of 'middle' sequences. Efficiencies are based on the use of linear mixed effects models. Results: In the studied settings, the modified design is more efficient than the three-sequence stepped wedge design with implementation periods. The parallel-group design with baseline and implementation periods with analysis of covariance-based analysis is often more efficient than the three-sequence design. With respect to stepped wedge designs with implementation periods that are comprised of more sequences, there are often corresponding modified designs that improve efficiency. However, use of only the first and last sequences has the potential to be either relatively efficient or inefficient. Relative efficiency is impacted by the strength of the statistical correlation among outcomes from the same cluster; for example, the relative efficiencies of modified designs tend to be greater for smaller cluster auto-correlation values. Conclusion: If a three-sequence stepped wedge design with implementation periods is being considered for a future cluster randomized trial, then a corresponding modified design using only the first and last sequences should be considered if sole focus is on efficiency. However, a parallel-group design with baseline and implementation periods and analysis of covariance-based analysis can be a practical, efficient alternative. For stepped wedge designs with implementation periods and a larger number of sequences, modified versions that remove 'middle' sequences should be considered. Due to the potential sensitivity of design efficiencies, statistical correlation should be carefully considered.
Language	English
Publishing date	2024-04-22
Publishing country	England
Document type	Journal Article
ZDB-ID	2138796-5
ISSN	1740-7753 ; 1740-7745
ISSN (online)	1740-7753
ISSN	1740-7745
DOI	10.1177/17407745241244790
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Article ; Online: Predictors of Stress Exposure in Hospitalized Preterm Infants.

Nist, Marliese Dion / Harrison, Tondi M / Shoben, Abigail B / Pickler, Rita H

Advances in neonatal care : official journal of the National Association of Neonatal Nurses

2023 Volume 23, Issue 6, Page(s) 575–582

Abstract: Background: Stress exposure in the neonatal intensive care unit (NICU) is associated with poor outcomes in preterm infants. However, factors predicting subsequent NICU stress exposure have not been identified.: Purpose: To characterize NICU stressors ...

Abstract	Background: Stress exposure in the neonatal intensive care unit (NICU) is associated with poor outcomes in preterm infants. However, factors predicting subsequent NICU stress exposure have not been identified. Purpose: To characterize NICU stressors experienced by preterm infants during the first 2 weeks of life and identify demographic, perinatal, and institutional variables associated with stress exposure. Methods: A secondary analysis of data from a nonexperimental, prospective study was conducted using data from 60 very preterm infants born 28 to 31 weeks gestational age. Stress exposures during the first 2 weeks of life, operationalized as number of invasive procedures, were characterized by type and quantity for each infant using data extracted from electronic health records. Associations between number of invasive procedures and demographic, perinatal, or institutional variables were analyzed using linear regressions with robust standard errors. Results: Preterm infants experienced, on average, 98 (SD = 41.8) invasive procedures. Of these invasive procedures, nasal and/or oral suctioning episodes (58.1%), followed by skin-breaking procedures (32.6%), were most frequent. Differences in the number of invasive procedures were found for maternal race; infants born to Black mothers experienced fewer total invasive procedures than infants born to White mothers. The number of invasive procedures also varied across NICUs. Implications for practice and research: Preterm infant stress exposure differed by maternal race and NICU, consistent with research findings of differential treatment of diverse infants. Further research is needed to understand the reasons for these differences and to identify best practices to standardize neonatal care.
MeSH term(s)	Infant ; Female ; Infant, Newborn ; Humans ; Infant, Premature ; Prospective Studies ; Infant, Very Low Birth Weight ; Mothers ; Intensive Care Units, Neonatal
Language	English
Publishing date	2023-09-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	2171013-2
ISSN	1536-0911 ; 1536-0903
ISSN (online)	1536-0911
ISSN	1536-0903
DOI	10.1097/ANC.0000000000001099
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Article: Internet Survey of Risk Factors Associated With Training and Competition in Dogs Competing in Agility Competitions.

Pechette Markley, Arielle / Shoben, Abigail B / Kieves, Nina R

Frontiers in veterinary science

2022 Volume 8, Page(s) 791617

Abstract: Objective: ...

Abstract	Objective:
Language	English
Publishing date	2022-01-04
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2834243-4
ISSN	2297-1769
ISSN	2297-1769
DOI	10.3389/fvets.2021.791617
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Article ; Online: Information growth for sequential monitoring of clinical trials with a stepped wedge cluster randomized design and unknown intracluster correlation.

Brown, Siobhan P / Shoben, Abigail B

Clinical trials (London, England)

2020 Volume 17, Issue 2, Page(s) 176–183

Abstract: Background/aims: In a stepped wedge study design, study clusters usually start with the baseline treatment and then cross over to the intervention at randomly determined times. Such designs are useful when the intervention must be delivered at the ... ...

Abstract	Background/aims: In a stepped wedge study design, study clusters usually start with the baseline treatment and then cross over to the intervention at randomly determined times. Such designs are useful when the intervention must be delivered at the cluster level and are becoming increasingly common in practice. In these trials, if the outcome is death or serious morbidity, one may have an ethical imperative to monitor the trial and stop before maximum enrollment if the new therapy is proven to be beneficial. In addition, because formal monitoring allows for the stoppage of trials when a significant benefit for new therapy has been ruled out, their use can make a research program more efficient. However, use of the stepped wedge cluster randomized study design complicates the implementation of standard group sequential monitoring methods. Both the correlation of observations introduced by the clustered randomization and the timing of crossover from one treatment to the other impact the rate of information growth, an important component of an interim analysis. Methods: We simulated cross-sectional stepped wedge study data in order to evaluate the impact of sequential monitoring on the Type I error and power when the true intracluster correlation is unknown. We studied the impact of varying intracluster correlations, treatment effects, methods of estimating the information growth, and boundary shapes. Results: While misspecified information growth can impact both the Type I error and power of a study in some settings, we observed little inflation of the Type I error and only moderate reductions in power across a range of misspecified information growth patterns in our simulations. Conclusion: Taking the study design into account and using either an estimate of the intracluster correlation from the ongoing study or other data in the same clusters should allow for easy implementation of group sequential methods in future stepped wedge designs.
MeSH term(s)	Analysis of Variance ; Cluster Analysis ; Cross-Over Studies ; Cross-Sectional Studies ; Humans ; Models, Statistical ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/statistics & numerical data ; Research Design ; Sample Size
Language	English
Publishing date	2020-02-06
Publishing country	England
Document type	Journal Article
ZDB-ID	2138796-5
ISSN	1740-7753 ; 1740-7745
ISSN (online)	1740-7753
ISSN	1740-7745
DOI	10.1177/1740774520901488
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Book: Epidemiology and biostatistics

Kestenbaum, Bryan / Shoben, Abigail B. / Adeney, Kathryn L.

an introduction to clinical research

2009

Author's details	Bryan Kestenbaum. Contrib. author Abigail B. Shoben. Ed. Kathryn L. Adeney
Language	English
Size	XIII, 242 S. : graph. Darst., 235 mm x 155 mm
Publisher	Springer Science+Business Media
Publishing place	New York, NY
Publishing country	United States
Document type	Book
HBZ-ID	HT016088651
ISBN	978-0-387-88432-5 ; 9780387884332 ; 0-387-88432-7 ; 0387884335
Database	Catalogue ZB MED Medicine, Health

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Shelf mark	Loan status	Location
2009 A 4870	order for loan	Magazin

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Article ; Online: Mindfulness-based Interventions Across the Cancer Continuum in the United States: A Scoping Review.

Emerson, Brent / Reddy, Menaka / Reiter, Paul L / Shoben, Abigail B / Klatt, Maryanna / Chakraborty, Subhankar / Katz, Mira L

American journal of health promotion : AJHP

2024 Volume 38, Issue 4, Page(s) 560–575

Abstract: Objective: To review mindfulness-based interventions (MBIs) tested in randomized controlled trials (RCT) across the cancer continuum.: Data source: Articles identified in PubMed, CINAHL, Web of Science, PsycINFO, and Embase.: Study inclusion and ... ...

Abstract	Objective: To review mindfulness-based interventions (MBIs) tested in randomized controlled trials (RCT) across the cancer continuum. Data source: Articles identified in PubMed, CINAHL, Web of Science, PsycINFO, and Embase. Study inclusion and exclusion criteria: Two independent reviewers screened articles for: (1) topic relevance; (2) RCT study design; (3) mindfulness activity; (4) text availability; (5) country (United States); and (6) mindfulness as the primary intervention component. Data extraction: Twenty-eight RCTs met the inclusion criteria. Data was extracted on the following variables: publication year, population, study arms, cancer site, stage of cancer continuum, participant demographic characteristics, mindfulness definition, mindfulness measures, mindfulness delivery, and behavioral theory. Data synthesis: We used descriptive statistics and preliminary content analysis to characterize the data and identify emerging themes. Results: A definition of mindfulness was reported in 46% of studies and 43% measured mindfulness. Almost all MBIs were tested in survivorship (50%) or treatment (46%) stages of the cancer continuum. Breast cancer was the focus of 73% of cancer-site specific studies, and most participants were non-Hispanic white females. Conclusion: The scoping review identified 5 themes: (1) inconsistency in defining mindfulness; (2) differences in measuring mindfulness; (3) underrepresentation of racial/ethnic minorities; (4) underrepresentation of males and cancer sites other than breast; and (5) the lack of behavioral theory in the design, implementation, and evaluation of the MBI.
MeSH term(s)	Male ; Female ; Humans ; United States ; Mindfulness ; Breast Neoplasms ; Research Design ; Text Messaging
Language	English
Publishing date	2024-01-11
Publishing country	United States
Document type	Review ; Journal Article
ZDB-ID	645160-3
ISSN	2168-6602 ; 0890-1171
ISSN (online)	2168-6602
ISSN	0890-1171
DOI	10.1177/08901171241227316
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Article ; Online: Internet-based survey of the frequency and types of orthopedic conditions and injuries experienced by dogs competing in agility.

Pechette Markley, Arielle / Shoben, Abigail B / Kieves, Nina R

Journal of the American Veterinary Medical Association

2021 Volume 259, Issue 9, Page(s) 1001–1008

Abstract: Objective: To describe the frequency and types of injuries experienced by dogs competing and training in agility and identify breed and geographic differences in frequency and types of injuries.: Sample: Surveys completed by owners of 4,701 dogs.: ... ...

Abstract	Objective: To describe the frequency and types of injuries experienced by dogs competing and training in agility and identify breed and geographic differences in frequency and types of injuries. Sample: Surveys completed by owners of 4,701 dogs. Procedures: The study involved an internet-based survey. Participants were asked whether their dog had ever had an injury that kept it from participating in agility for > 1 week and, if so, to identify the location and type of injury. Results: Owners of 1,958 (41.7%) dogs reported that their dogs had experienced an injury. The most common injury locations were the shoulder region (n = 589 [30.1% of all dogs with an injury]) and iliopsoas muscle (380 [19.4%]). The percentage of Border Collies sustaining an injury (549/1,052 [51.9%]) was significantly higher than percentages of other breeds. Percentage of dogs that sustained an injury varied by country, with the highest percentage reported in Australia (93/174 [53.4%]) and lowest percentage reported in the US (1,149/2,889 [39.8%]). Conclusions and clinical relevance: Results suggested that, among dogs competing and training in agility, injuries to the shoulder region were substantially more common than injuries in other anatomic locations, with iliopsoas muscle injuries second most common. The frequency and types of injuries varied among breeds and geographic regions. Findings may help guide clinical evaluations when agility dogs are seen in clinical practice for performance issues or lameness. Further studies regarding regional differences in injury rates are required.
MeSH term(s)	Animals ; Australia ; Dog Diseases/epidemiology ; Dogs ; Internet ; Musculoskeletal Diseases/veterinary ; Surveys and Questionnaires
Language	English
Publishing date	2021-10-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	390811-2
ISSN	1943-569X ; 0003-1488
ISSN (online)	1943-569X
ISSN	0003-1488
DOI	10.2460/javma.259.9.1001
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Zs.A 423: Show issues

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Article ; Online: Lower centrifugation speed and time are positively associated with platelet concentration in a canine autologous conditioned plasma system.

Goodale, Margaret B / Phelps, Holly A / Barnhard, Jennifer A / Shoben, Abigail B / Brunke, Matthew W

Journal of the American Veterinary Medical Association

2023 Volume 261, Issue 11, Page(s) 1–6

Abstract: Objective: To evaluate the effect of variable centrifugation protocols on the cellular composition of the final product of a canine autologous conditioned plasma double-syringe system.: Animals: 30 client-owned healthy adult medium- to large-breed ( ... ...

Abstract	Objective: To evaluate the effect of variable centrifugation protocols on the cellular composition of the final product of a canine autologous conditioned plasma double-syringe system. Animals: 30 client-owned healthy adult medium- to large-breed (17- to 45-kg) dogs. Methods: 35 mL of anticoagulated whole blood from each subject was aliquoted into 3 samples: a baseline and 2 double syringes. The syringes were processed for platelet-rich plasma (PRP). Each double syringe was randomly assigned to 1 of 5 groups, which varied in centrifugation settings between 580 and 1,304 X g and 5 and 10 minutes. CBC analysis was performed on each of the samples to determine cellular composition. A mixed-effect linear model was fit to the data. Results: 60 PRP samples and 30 whole blood samples were analyzed. Manufacturer settings generated a platelet fold change > 1 but did not increase concentration to the extent expected. When comparing speed alone, increased centrifugation force was associated with lower platelet fold change. When comparing time alone, increased centrifugation time was also associated with lower platelet fold change and lower leukocyte concentration. Clinical relevance: Autologous conditioned plasma double syringes require a low volume of initial whole blood, making them preferable for canine PRP in clinical settings. This study aimed to evaluate the effect of the centrifugation protocol on the final product cellular composition in dogs and add to the available data on protocols to maximize platelet yield in PRP. Due to inherent individual variability, this study emphasized the importance of evaluating biological samples prior to administration to predict and improve patient outcomes.
MeSH term(s)	Animals ; Dogs ; Blood Platelets ; Centrifugation/veterinary ; Centrifugation/methods ; Platelet-Rich Plasma ; Random Allocation
Language	English
Publishing date	2023-08-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	390811-2
ISSN	1943-569X ; 0003-1488
ISSN (online)	1943-569X
ISSN	0003-1488
DOI	10.2460/javma.23.04.0218
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Article ; Online: Differences in obesity-related health behaviors and health outcomes by rural and Appalachian residency.

Zhang, Xiaochen / Shoben, Abigail B / Felix, Ashley S / Focht, Brian C / Paskett, Electra D

Cancer causes & control : CCC

2023 Volume 34, Issue 12, Page(s) 1113–1121

Abstract: Purpose: Obesity and health behaviors are the major modifiable contributors to cancer and health disparities. We examined the differences in obesity-related health behaviors, and health outcomes by rural and Appalachian residency in Ohio.: Methods: ... ...

Abstract	Purpose: Obesity and health behaviors are the major modifiable contributors to cancer and health disparities. We examined the differences in obesity-related health behaviors, and health outcomes by rural and Appalachian residency in Ohio. Methods: Cross-sectional survey data from the 2011-2019 Behavioral Risk Factor Surveillance System were obtained from the Ohio Department of Health. County-level identifiers were used to classify urban non-Appalachian, urban Appalachian, rural non-Appalachian, and rural Appalachian residency. Self-reported weight, height, health behaviors, and health conditions were used. Logistic regression was used to assess the difference in health behaviors and health outcomes by rural and Appalachian residency. All analyses incorporated with sample weights. Results: Among Ohio residents, compared to urban non-Appalachian residents, urban Appalachian and rural Appalachian residents had a higher prevalence of obesity, hypertension, high cholesterol, and cardiovascular diseases, as well as lower rates of healthy diet and physical activity. No difference was found in trends of obesity and obesity-related health outcomes in 2011-2019 by rural and Appalachian residency. However, rural Appalachian residents had a greater increase in obesity, hypertension, and diabetes, whereas rural non-Appalachian had favorable changes in obesity-related health behaviors. Additionally, associations between health behaviors and obesity-related health outcomes differed by rural and Appalachian residency. Conclusions: Findings underscore the importance of distinguishing between urban non-Appalachian, urban Appalachian, rural non-Appalachian, and rural Appalachian populations when assessing health disparities. While the trends of obesity and obesity-related health outcomes did not differ, the association between health behaviors and obesity-related outcomes differed by rural and Appalachian residency.
MeSH term(s)	Humans ; Cross-Sectional Studies ; Internship and Residency ; Obesity/epidemiology ; Health Behavior ; Hypertension/complications ; Outcome Assessment, Health Care ; Rural Population
Language	English
Publishing date	2023-07-27
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1064022-8
ISSN	1573-7225 ; 0957-5243
ISSN (online)	1573-7225
ISSN	0957-5243
DOI	10.1007/s10552-023-01741-8
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Article ; Online: Overall success rate of a safe and efficacious drug: Results using six phase 1 designs, each followed by standard phase 2 and 3 designs.

Ruppert, Amy S / Shoben, Abigail B

Contemporary clinical trials communications

2018 Volume 12, Page(s) 40–50

Abstract: To evaluate the overall success rate of a new drug, phase 1, 2, and 3 trials were simulated using eight toxicity and two non-decreasing efficacy profiles. Six phase 1 designs including the standard 3 + 3, CCD, BOIN, mTPI, mTPI-2, and CRM were considered ... ...

Abstract	To evaluate the overall success rate of a new drug, phase 1, 2, and 3 trials were simulated using eight toxicity and two non-decreasing efficacy profiles. Six phase 1 designs including the standard 3 + 3, CCD, BOIN, mTPI, mTPI-2, and CRM were considered with standard phase 2 and 3 designs. Based on our results, phase 1 design recommendations are provided when data informing the general shape of the dose-toxicity curve exist. If a large jump in toxicity between dose levels is expected, the standard 3 + 3 design is recommended; it more often recognized when the MTD was exceeded and had the highest overall success rates. If gradually increasing toxicity is expected, a nonstandard design other than the CRM is recommended. Nonstandard designs were more aggressive in dosing and MTD estimation than the standard 3 + 3 and had higher overall success rates, but the CRM was too aggressive and most frequently overestimated the true MTD. If fairly constant, safe toxicity is expected across dose levels, the BOIN or CRM designs are recommended; they escalated to the highest dose most frequently with superior overall success rates. Without data informing the shape of the dose-toxicity curve, nonstandard phase 1 designs with a modified excessive toxicity rule more easily eliminating unsafe dose levels are recommended. With this modification, MTD overestimation error decreased and overall success rates were similar or higher with nonstandard designs. Among nonstandard designs, the modified CCD and BOIN perform well and are as transparent and simple to implement as the standard 3 + 3 design.
Language	English
Publishing date	2018-08-24
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2018.08.010
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