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538 results on '"Shan, Guogen"'

1. Rationale and Design for the BLOCK-SAH Study (Pterygopalatine Fossa Block as an Opioid-Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage): A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial with a Sequential Parallel Comparison Design

Author

Busl, Katharina M., Smith, Cameron R., Troxel, Andrea B., Fava, Maurizio, Illenberger, Nicholas, Pop, Ralisa, Yang, Wenqing, Frota, Luciola Martins, Gao, Hanzhi, Shan, Guogen, Hoh, Brian L., and Maciel, Carolina B.

Published
2024
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4. Contributors

Author

Albert, Paul S., primary, Allotey, Prince A., additional, Appleton, Allison A., additional, Attwood, Kristopher, additional, Bergsland, Niels, additional, Bernick, Charles, additional, Chakraborty, Saptarshi, additional, Chen, Zhen, additional, Desai, Gauri, additional, Dodge Francis, Carolee, additional, Dwyer, Michael, additional, Feingold, Beth J., additional, Gao, Xinyu, additional, Harel, Ofer, additional, Holdsworth, Elizabeth A., additional, Hong, Xuan, additional, Kim, Sung Duk, additional, Kordas, Katarzyna, additional, Ledsham, Victoria, additional, Lin, Betty, additional, Liu, Jingxia, additional, Miecznikowski, Jeffrey C., additional, Miller, Austin, additional, Park, Soyun, additional, Shan, Guogen, additional, Sill, Michael, additional, Szapudi, Istvan, additional, Vahter, Marie, additional, Vexler, Albert, additional, Vexler, David, additional, Yu, Jihnhee, additional, Zhou, Jiaojiao, additional, and Zivadinov, Robert, additional

Published
2024
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15. Sample size calculation for the sequential parallel comparison design with binary endpoint using exact methods.

Author

Shan, Guogen and Zhang, Yahui

Subjects
*FALSE positive error, *SAMPLE size (Statistics), *STATISTICAL sampling, *ORDER statistics, *DRUG efficacy, *ERROR rates
Abstract

High placebo responses in clinical trial could reduce the treatment effect leading to the failure of a promising drug. Several strategies have been developed to minimize high placebo responses, including the sequential parallel comparison design (SPCD). For a study with binary outcome, the existing statistical methods to test the drug effectiveness always rely on the asymptotic limiting distribution. When a study's sample size is small to medium, the asymptotic approaches do not have satisfactory performance with regard to type I error rate and statistical power. For that reason, we propose utilizing exact conditional approach to calculate sample size based on the existing test statistics to order the sample space. The proposed method controls the type I error rate under the unconditional framework. We compare the proposed exact sample sizes using different test statistics and the sample size for a randomized parallel study. We would recommend using exact sample sizes for the SPCD with small- to medium sample sizes and the SPCD with extreme response rates. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Two-stage response adaptive randomization designs for multi-arm trials with binary outcome.

Author

Lu, Xinlin and Shan, Guogen

Subjects
*NULL hypothesis
Abstract

In recent years, adaptive randomization methods have gained significant popularity in clinical research and trial design due to their ability to provide both efficiency and flexibility in adjusting the statistical procedures of ongoing clinical trials. For a study to compare multiple treatments, a multi-arm two-stage design could be utilized to select the best treatment from the first stage and further compare that treatment with control in the second stage. The traditional design used equal randomization in both stages. To better utilize the interim results from the first stage, we propose to develop response adaptive randomization two-stage designs for a multi-arm clinical trial with binary outcome. Two allocation methods are considered: (1) an optimal allocation based on a sequential design; (2) the play-the-winner rule. Optimal multi-arm two-stage designs are obtained under three criteria: minimizing the expected number of failures, minimizing the average expected sample size, and minimizing the expected sample size under the null hypothesis. Simulation studies show that the proposed adaptive design based on the play-the-winner rule has good performance. A phase II trial for patients with pancreas adenocarcinoma and a germline BRCA $/$ / PALB2 mutation was used to illustrate the application of the proposed response adaptive randomization designs. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Planning for Safe Hospital Discharge by Identifying Patients Likely to Fall After Discharge

Author

Wright, Jonathan R., Koch-Hanes, Trisha, Cortney, Ciera, Lutjens, Kathryn, Raines, Kristopher, Shan, Guogen, and Young, Daniel

Subjects
Falls (Accidents) -- Risk factors -- Prevention, Hospitals -- Admission and discharge, Physical therapists -- Practice, Company business planning, Health
Abstract

Objective. Acute care physical therapists recommend discharge locations and services in part to help prevent falls during post-discharge recovery. Therapists may use standardized tests to inform their recommendation decisions, but evidence linking test scores with fall risk after discharge is lacking. The primary purpose of this study was to explore the associations between Tinetti Performance-Oriented Mobility Assessment (POMA) and Activity Measure for Post-Acute Care Inpatient Mobility Short Form (AM-PAC IMSF) scores and falls in the first 30 days after hospital discharge. Anticipating that agreement between therapist recommendations and discharge locations and services (discharge agreement), age, and sex could impact those associations, these factors were included in this investigation. Methods. In this observational cohort study, 258 hospitalized patients consented to medical record data extraction and answered a phone survey 30 days after discharge to report whether they had experienced a fall since leaving the hospital. POMA and AM-PAC IMSF tests were administered for every patient. Participants' age, sex, diagnosis, last POMA score, last AM-PAC IMSF score, physical therapist discharge recommendations, actual discharge location and services, discharge date, and phone number were collected from their medical records. Results. When analyzed alone, higher POMA scores were associated with lower odds of falling, but the association was not significant after adjustment for other factors. Neither AM-PAC IMSF scores, age, nor sex were associated with falls. Discharge agreement, however, was associated with 59% lower odds of falling after adjustment for other factors. Conclusion. Participants, who were discharged to the location with the services recommended by their physical therapist, were less likely to fall. Tinetti POMA and AM-PAC IMSF scores did not discriminate well participants who would fall. Impact. Findings in this study inform those involved in discharge planning on the value of implementing physical therapist recommendations in reducing fall risk after hospital discharge. Lay Summary. If physical therapist discharge recommendations are implemented, patients are less likely to fall during the month after hospital discharge. Balance and mobility test scores may provide therapists valuable information, but they are limited in their ability to identify who will fall after discharge. Keywords: Accidental Falls, Acute Care, Adult, Balance, Introduction Falls are among the most common and serious problems the United States health care system must address. They are a leading cause of mortality and morbidity among older adults. [...]

Published
2022
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21. A Research Protocol to Study the Priming Effects of Breathing Low Oxygen on Enhancing Training-Related Gains in Walking Function for Persons With Spinal Cord Injury: The BO2ST Trial

Author

Muter, William M., primary, Mansson, Linda, additional, Tuthill, Christopher, additional, Aalla, Shreya, additional, Barth, Stella, additional, Evans, Emily, additional, McKenzie, Kelly, additional, Prokup, Sara, additional, Yang, Chen, additional, Sandhu, Milap, additional, Rymer, W. Zev, additional, Edgerton, Victor R., additional, Gad, Parag, additional, Mitchell, Gordon S., additional, Wu, Samuel S., additional, Shan, Guogen, additional, Jayaraman, Arun, additional, and Trumbower, Randy D., additional

Published
2023
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25. Continuity corrected score confidence interval for the difference in proportions in paired data.

Author

Chang, Peter, Liu, Rongzi, Hou, Tingting, Yan, Xinyu, and Shan, Guogen

Subjects
PROBABILITY theory
Abstract

For paired binary data, the hybrid method and the score method are often recommended for use to calculate the confidence interval for risk difference. These asymptotic intervals do not control the coverage probability. We propose to develop a new score interval with continuity correction to further improve the performance of the existing intervals. The traditional correction value may be too large which leads to a wide interval. For that reason, we propose three different correction values to identify the optimal correction interval with balanced coverage probability and interval width. From simulation studies, we find that a small correction value for the score interval has good performance. In addition, we derive the non-iterative solutions for the developed continuity correction score intervals. [ABSTRACT FROM AUTHOR]

Published
2024
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37. The BOOST Trial: Breathing Low Oxygen To Enhance Spinal Neuromodulation Training in Persons With SCI

Author

Muter, William, primary, Prokup, Sara, additional, Tuthill, Christopher, additional, Evans, Emily, additional, Barth, Stella, additional, Mitchell, Gordon, additional, Link, Angela, additional, Shan, Guogen, additional, Sandhu, Milap, additional, Edgerton, VR, additional, Gad, Parag, additional, Slocum, Chloe, additional, Zafonte, Ross, additional, and O'Brien, Randy, Megan, additional

Published
2023
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