Article
Statistics & Probability
Junwei Shen, Shirin Golchi, Erica E. M. Moodie, David Benrimoh
Summary: This study discusses the flexible designs for cluster-randomized trials and proposes two Bayesian group sequential designs to assess the effectiveness of a machine-learning based clinical decision support system for physicians treating patients with depression. The operating characteristics of these designs are explored via simulations, and recommendations are made based on the results.
Review
Medicine, General & Internal
Kelley M. Kidwell, Daniel Almirall
Summary: This article explains sequential, multiple assignment, randomized trial (SMART) study designs, where participants are randomized at 2 or more decision points depending on their response to prior treatment.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
(2023)
Article
Medicine, Research & Experimental
David M. Murray
Summary: This article identifies and analyzes the most influential methods reports for group-randomized trials and related designs published through 2020, highlighting 55 reports that have had a significant impact. These reports cover methods and issues related to group-randomized trials, individually randomized group treatment trials, and stepped wedge group-randomized trials.
Article
Economics
Y. U. E. H. A. O. Bai
Summary: This article examines the application of stratified randomization in randomized controlled trials and finds that a certain matched-pair design achieves the highest statistical precision for estimating the average treatment effect. In certain special cases, pairing units based on the baseline outcome can lead to optimal results.
AMERICAN ECONOMIC REVIEW
(2022)
Article
Oncology
Emily C. Zabor, Alexander M. Kaizer, Nathan A. Pennell, Brian P. Hobbs
Summary: This study proposes three randomized designs for early phase biomarker-guided oncology clinical trials, using optimal efficiency predictive probability method to monitor multiple biomarker subpopulations for futility. The simulation study demonstrates that potentially smaller phase II trials can be designed efficiently using randomization and futility stopping to obtain more information before phase III studies.
FRONTIERS IN ONCOLOGY
(2022)
Review
Oncology
Wim Ceelen, Kjetil Soreide
Summary: Surgery is crucial for the treatment of solid cancers and plays an important role in multimodal cancer management. Surgeons and multidisciplinary teams make decisions based on reliable data, preferably from trials, to provide the best care for cancer patients. Enhancing research literacy among surgical candidates is a priority for the development of the ESSO core curriculum, and a set of principles and emerging concepts is presented to guide surgical oncologists in reading, understanding, planning, and contributing to future surgeon-led cancer trials.
Review
Oncology
Giulia Lorenzoni, Elisabetta Petracci, Emanuela Scarpi, Ileana Baldi, Dario Gregori, Oriana Nanni
Summary: Sequential multiple assignments randomized trials (SMARTs) are an experimental design in which patients are randomized multiple times according to pre-specified decision rules. This study investigates the current state of SMART designs in oncology and identifies a discrepancy between the statistical literature and actual procedures used in cancer clinical trials. A systematic review found that SMART designs in oncology are still limited and there is a need for formal reporting guidelines.
BRITISH JOURNAL OF CANCER
(2023)
Review
Nutrition & Dietetics
Di Liu, Xiaoni Meng, Qiuyue Tian, Weijie Cao, Xin Fan, Lijuan Wu, Manshu Song, Qun Meng, Wei Wang, Youxin Wang
Summary: Observational studies, randomized controlled trials, and Mendelian randomization studies have found inconsistent results on the associations of vitamin D concentrations with multiple health outcomes. Lower concentrations of vitamin D are associated with higher risk for all-cause mortality, Alzheimer's disease, hypertension, schizophrenia, and type 2 diabetes. Vitamin D supplementation is associated with decreased risk for all-cause mortality but not for Alzheimer's disease, hypertension, schizophrenia, or type 2 diabetes.
ADVANCES IN NUTRITION
(2022)
Review
Health Care Sciences & Services
Sujata Purja, Sunuk Park, SuA Oh, Minji Kim, EunYoung Kim
Summary: The objective of this study was to evaluate the reporting quality of randomized controlled trials (RCTs) using adaptive design (AD) based on the 2020 AD Consolidated Standards for Reporting Trials 2010 extension (ACE) guidelines. A total of 109 RCTs were included in the study, and the mean compliance rate for the ACE checklist items was found to be 69.75% ± 16.02. Key methodological items, such as allocation concealment, were poorly reported, and there was suboptimal reporting of checklist items related to interim analyzes. The study concluded that stricter adherence to the ACE guidelines is necessary to improve the reporting quality of RCTs with AD.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2023)
Article
Education, Special
Jennifer R. Ledford, Kathleen N. Zimmerman
Summary: This article discusses resources available for evaluating the rigor of single-case designs, specifically focusing on the commonly used multiple baseline design. The authors explore the characteristics of concurrence and response-guided baseline condition duration, commonly cited as necessary for high rigor in multiple baseline designs. They suggest that nonconcurrence and response-independent baseline condition duration may be appropriate in certain situations. The article also recommends improved reporting and graphing for researchers and calls for future research to determine experimental differences when these design variations are used.
REMEDIAL AND SPECIAL EDUCATION
(2023)
Article
Health Care Sciences & Services
Amra Hot, Patrick M. Bossuyt, Oke Gerke, Simone Wahl, Werner Vach, Antonia Zapf
Summary: Diagnostic accuracy studies focus on the accuracy of new experimental tests, while randomized test-treatment studies evaluate the impact of diagnostic information on treatment strategies and patient outcomes. However, the various designs and inconsistent nomenclature in the literature pose challenges, highlighting the need for further research on these complex studies.
BMC MEDICAL RESEARCH METHODOLOGY
(2021)
Article
Political Science
Naoki Egami, Soichiro Yamauchi
Summary: This article investigates how to improve the difference-in-differences (DID) design with multiple pretreatment periods. It first clarifies three benefits of multiple pretreatment periods using potential outcomes and then proposes a new estimator, double DID, which contains the two-way fixed effects regression as a special case. The article also generalizes the double DID to the staggered adoption design. Empirical applications demonstrate the effectiveness of the proposed methods and an open-source R package is provided for implementation.
POLITICAL ANALYSIS
(2023)
Article
Respiratory System
Corey E. Ventetuolo, Jude Moutchia, Grayson L. Baird, Dina H. Appleby, Robyn L. McClelland, Jasleen Minhas, Jeff Min, John H. Holmes, Ryan J. Urbanowicz, Nadine Al-Naamani, Steven M. Kawut
Summary: This study found that sex differences have an impact on baseline 6-minute walk distance, hemodynamics, and functional class in pulmonary arterial hypertension (PAH). Females had shorter 6MWD, higher cardiac index, and lower right atrial pressure and mean pulmonary artery pressure. Age and body mass index modulated the relationship between sex and these outcomes. The study suggests that sex, age, and body size should be taken into consideration in the evaluation and interpretation of surrogate outcomes in PAH.
ANNALS OF THE AMERICAN THORACIC SOCIETY
(2023)
Article
Geriatrics & Gerontology
Sarah L. Szanton, Bruce Leff, Qiwei Li, Jill Breysse, Sandra Spoelstra, Judith Kell, James Purvis, Qian-Li Xue, Jonathan Wilson, Laura N. Gitlin
Summary: The CAPABLE program showed substantial improvements in activities of daily living and instrumental activities of daily living in all six trials, with varying outcomes for other factors. Studies implementing the full-tested dose of CAPABLE demonstrated more improvement in activities of daily living and cost savings than studies implementing a decreased dose.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY
(2021)
Article
Gastroenterology & Hepatology
Katharina Zimmermann-Fraedrich, Heiko Pohl, Thomas Roesch, Douglas K. Rex, Cesare Hassan, Evelien Dekker, Michal Filip Kaminski, Michael Bretthauer, Jocelyn de Heer, Yuki Werner, Guido Schachschal, Stefan Groth
Summary: Results from tandem trials are more likely to show positive outcomes compared to parallel trials, possibly due to the use of different parameters, definitions, and methods, as well as a higher likelihood of bias. Therefore, positive results from tandem studies should only be accepted if they are accompanied by positive results from parallel trials.
Article
Public, Environmental & Occupational Health
M. Carolina Danovaro-Holliday, Dale A. Rhoda, Mona Lacoul, Mary L. Prier, Jhalak Sharma Gautam, Tara Nath Pokhrel, Sameer Mani Dixit, Rajesh Man Rajbhandari, Anindya Sekhar Bose
Summary: Coverage of the measles-rubella vaccine varied by geographical region, with higher rates in rural areas compared to urban areas in Nepal. The most significant predictor of vaccination was informing caregivers in advance about the vaccination campaign.
Article
Emergency Medicine
Megan L. Hutchcraft, Oluwabusola Ola, Eric M. McLaughlin, Erinn M. Hade, Andrew J. Murphy, Heather A. Frey, Ashley Larrimore, Ashish R. Panchal
Summary: This study evaluated the association between prehospital obstetric population who used emergency medical services (EMS) and hypertensive disorders of pregnancy, finding that hypertension is common in this population, especially in wealthier areas. Prehospital management should focus on the identification and treatment of severe hypertension.
PREHOSPITAL EMERGENCY CARE
(2022)
Article
Social Sciences, Mathematical Methods
Rebecca Roberts Andridge, Katherine Jenny Thompson
Summary: The U.S. Census Bureau historically used nearest neighbor or random hot deck imputation to handle missing survey data. Nearest neighbor imputation is preferred for its precision and robustness against misspecified response mechanisms, while random hot deck imputation ignores auxiliary information. K-nearest neighbor imputation is a compromise between the two methods. However, using the Approximate Bayesian Bootstrap method for nearest neighbor imputation leads to variance underestimation.
JOURNAL OF SURVEY STATISTICS AND METHODOLOGY
(2023)
Article
Multidisciplinary Sciences
Justice Moses K. A. Aheto, Oliver T. Pannell, Winfred Dotse-Gborgbortsi, Mary Trimner, Andrew Tatem, Dale Rhoda, Felicity Cutts, C. Edson Utazi
Summary: The study identified factors affecting childhood vaccination coverage in Nigeria, including ownership of health cards/documents, receipt of Vitamin A, maternal education level, socio-economic status, and access to healthcare. Urban residence and ethnic group were also found to be significant factors. The study suggests addressing socio-economic factors and healthcare access issues to reduce inequalities in vaccination coverage.
Article
Public, Environmental & Occupational Health
Mark A. A. Klebanoff, Erinn M. M. Hade
Summary: Short interpregnancy interval is associated with increased risk of preterm delivery. Results from within-sibship analysis are similar to between-person analysis, but differ from the full cohort.
PAEDIATRIC AND PERINATAL EPIDEMIOLOGY
(2023)
Article
Public, Environmental & Occupational Health
Courtney D. Lynch, Sara Conroy, Kenneth A. Jackson, Rachel M. Smith, Erinn M. Hade
Summary: This study aimed to assess the impact of modernisation of non-emergency medical transportation services on patient satisfaction, prenatal care utilization, and preterm delivery. A randomised controlled pilot trial was conducted among pregnant Medicaid recipients in Franklin County, Ohio. The results showed that enhanced smart transportation services, compared to usual transportation, increased satisfaction with transportation services among pregnant women. However, there were no significant effects on prenatal care utilization and preterm delivery.
PAEDIATRIC AND PERINATAL EPIDEMIOLOGY
(2023)
Article
Anesthesiology
Annelise A. Madison, Megan Renna, Rebecca Andridge, Juan Peng, M. Rosie Shrout, John Sheridan, Maryam Lustberg, Bhuvaneswari Ramaswamy, Robert Wesolowski, Nicole O. Williams, Anne M. Noonan, Raquel E. Reinbolt, Daniel G. Stover, Mathew A. Cherian, William B. Malarkey, Janice K. Kiecolt-Glaser
Summary: Individuals respond differently to inflammation. Pain, sadness, and fatigue are common correlates of inflammation among breast cancer survivors. This study found that breast cancer survivors who experienced chronic social stress were more likely to report pain and sadness in response to increases in IL-1Ra.
Article
Communication
Brady T. West, Rebecca R. Andridge
Summary: Among various explanations for recent errors in pre-election polls, selection bias due to non-ignorable partisan nonresponse bias has received relatively less attention. This study introduces a new measure to detect and adjust for this type of bias in estimating the proportion of likely voters for a specific candidate. Using data from 18 pre-election polls conducted in the US and UK, the study rigorously evaluates the effectiveness of the measure by comparing it with official outcomes and alternative data sources.
PUBLIC OPINION QUARTERLY
(2023)
Article
Oncology
Annelise A. Madison, Rebecca Andridge, Anthony H. Kantaras, Megan E. Renna, Jeanette M. Bennett, Catherine M. Alfano, Stephen P. Povoski, Doreen M. Agnese, Maryam Lustberg, Robert Wesolowski, William E. Carson III, Nicole O. Williams, Raquel E. Reinbolt, Sagar D. Sardesai, Anne M. Noonan, Daniel G. Stover, Mathew A. Cherian, William B. Malarkey, Janice K. Kiecolt-Glaser
Summary: Depression combined with inflammation or intestinal permeability may contribute to poorer subjective and objective cognitive function in breast cancer survivors. These findings suggest that survivors with depression accompanied by immune dysregulation may be more aware of depression-related cognitive deficits compared to other depressed survivors.
Article
Immunology
Tamara Rivera, Jennifer Brustrom, Maite Vera Antelo, E. Benjamin Puertas, Dale A. Rhoda, Martha Velandia-Gonzalez
Summary: Health workers play a key role in promoting vaccine acceptance. The study shows that although nearly all respondents believe that the COVID-19 vaccine is safe and effective, 59% expressed concerns about potential adverse effects. Respondents' attitudes towards vaccines are influenced by social processes, with varying effects across different demographic and geographic subgroups.
Article
Pediatrics
Bharathi J. Zvara, Sarah A. Keim, Rebecca Andridge, Sarah E. Anderson
Summary: Sensitive and responsive parenting supports optimal growth and development in children across cultures. Self-compassion has been found to be positively related to sensitive parenting. However, there is still limited research on the associations between self-compassion, depressive symptoms, socioeconomic status, and sensitive parenting.
Article
Psychology, Multidisciplinary
Megan E. Renna, Annelise A. Madison, Juan Peng, Marcella Rosie Shrout, Maryam Lustberg, Bhuvaneswari Ramaswamy, Robert Wesolowski, Jeffrey B. VanDeusen, Nicole O. Williams, Sagar D. Sardesai, Anne M. Noonan, Raquel E. Reinbolt, Daniel G. Stover, Mathew Cherian, William B. Malarkey, Rebecca Andridge, Janice K. Kiecolt-Glaser
Summary: This study examined the impact of emotion regulation strategies on breast cancer survivors. It found that higher levels of worry and lower levels of mindfulness were associated with memory problems, focus problems, and pain sensitivity.
ANNALS OF BEHAVIORAL MEDICINE
(2023)
Article
Cardiac & Cardiovascular Systems
Dike Ojji, Angela Aifah, Juliet Iwelunmor, Erinn M. Hade, Deborah Onakomaiya, Calvin Colvin, Shivani Mishra, Nafesa Kanneh, Ashlin Rakhra, Gabriel Shedul, Daniel Henry, Adrian Duah, Daphne Lew, Geetha P. Bansal, Angela Attah, Gbenga Ogedegbe, Anyiekere Ekanem
Summary: Insufficient training of non-physician healthcare workers could hinder the successful integration of cardiovascular disease management into HIV chronic care. However, this study showed that a training program for community nurses improved their knowledge of managing hypertension in persons living with HIV and was highly rated by participants.
Article
Health Care Sciences & Services
E. Benjamin Puertas, Martha Velandia-Gonzalez, Lauren Vulanovic, Lisa Bayley, Karen Broome, Claudia Ortiz, Nina Rise, Maite Vera Antelo, Dale A. Rhoda
Summary: Healthcare workers in the Caribbean play a critical role in promoting vaccination but some of them exhibit vaccine hesitancy. A survey conducted among healthcare workers in the Caribbean revealed that the majority expressed clear intention to get vaccinated for COVID-19 as soon as possible, however, nurses, allied health professionals, and younger respondents showed relatively lower intention to be vaccinated and higher levels of vaccine hesitancy compared to physicians and older respondents.
LANCET REGIONAL HEALTH-AMERICAS
(2022)
Article
Public, Environmental & Occupational Health
Erinn M. Hade, Courtney D. Lynch, Jason A. Benedict, Rachel M. Smith, Danielle D. Ding, Steven G. Gabbe, Patricia Temple Gabbe
Summary: The study results indicated that participation in the Moms2B program leads to improved pregnancy and infant outcomes, particularly among non-Hispanic Black women with high-risk pregnancies.
MATERNAL AND CHILD HEALTH JOURNAL
(2022)
