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6. Performance of mixed effects models and generalized estimating equations for continuous outcomes in partially clustered trials including both independent and paired data.

Author

Lange, Kylie M., Sullivan, Thomas R., Kasza, Jessica, and Yelland, Lisa N.

Subjects
*GENERALIZED estimating equations, *FALSE positive error, *MULTIPLE birth, *TREATMENT effectiveness, *CLUSTER sampling
Abstract

Many clinical trials involve partially clustered data, where some observations belong to a cluster and others can be considered independent. For example, neonatal trials may include infants from single or multiple births. Sample size and analysis methods for these trials have received limited attention. A simulation study was conducted to (1) assess whether existing power formulas based on generalized estimating equations (GEEs) provide an adequate approximation to the power achieved by mixed effects models, and (2) compare the performance of mixed models vs GEEs in estimating the effect of treatment on a continuous outcome. We considered clusters that exist prior to randomization with a maximum cluster size of 2, three methods of randomizing the clustered observations, and simulated datasets with uninformative cluster size and the sample size required to achieve 80% power according to GEE‐based formulas with an independence or exchangeable working correlation structure. The empirical power of the mixed model approach was close to the nominal level when sample size was calculated using the exchangeable GEE formula, but was often too high when the sample size was based on the independence GEE formula. The independence GEE always converged and performed well in all scenarios. Performance of the exchangeable GEE and mixed model was also acceptable under cluster randomization, though under‐coverage and inflated type I error rates could occur with other methods of randomization. Analysis of partially clustered trials using GEEs with an independence working correlation structure may be preferred to avoid the limitations of mixed models and exchangeable GEEs. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Cost-Effectiveness and Value of Information Analysis of an Ambient Intelligent Geriatric Management (AmbIGeM) System Compared to Usual Care to Prevent Falls in Older People in Hospitals

Author

Pham, Clarabelle T., primary, Visvanathan, Renuka, additional, Strong, Mark, additional, Wilson, Edward C. F., additional, Lange, Kylie, additional, Dollard, Joanne, additional, Ranasinghe, Damith, additional, Hill, Keith, additional, Wilson, Anne, additional, and Karnon, Jonathan, additional

Published
2022
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28. Quinine Effects on Gut and Pancreatic Hormones and Antropyloroduodenal Pressures in Humans-Role of Delivery Site and Sex

Author

Rezaie, Peyman, Bitarafan, Vida, Rose, Braden D., Lange, Kylie, Rehfeld, Jens F., Horowitz, Michael, Feinle-Bisset, Christine, Rezaie, Peyman, Bitarafan, Vida, Rose, Braden D., Lange, Kylie, Rehfeld, Jens F., Horowitz, Michael, and Feinle-Bisset, Christine

Abstract

Context: The bitter substance quinine modulates the release of a number of gut and gluco-regulatory hormones and upper gut motility. As the density of bitter receptors may be higher in the duodenum than the stomach, direct delivery to the duodenum may be more potent in stimulating these functions. The gastrointestinal responses to bitter compounds may also be modified by sex. Background: We have characterized the effects of intragastric (IG) versus intraduodenal (ID) administration of quinine hydrochloride (QHCl) on gut and pancreatic hormones and antropyloroduodenal pressures in healthy men and women. Methods: 14 men (26±2 years, BMI: 22.2±0.5 kg/m2) and 14 women (28±2 years, BMI: 22.5±0.5 kg/m2) received 600 mg QHCl on 2 separate occasions, IG or ID as a 10-mL bolus, in randomized, double-blind fashion. Plasma ghrelin, cholecystokinin, peptide YY, glucagon-like peptide-1 (GLP-1), insulin, glucagon, and glucose concentrations and antropyloroduodenal pressures were measured at baseline and for 120 minutes following QHCl. Results: Suppression of ghrelin (P=0.006), stimulation of cholecystokinin (P=0.030), peptide YY (P=0.017), GLP-1 (P=0.034), insulin (P=0.024), glucagon (P=0.030), and pyloric pressures (P=0.050), and lowering of glucose (P=0.001) were greater after ID-QHCl than IG-QHCl. Insulin stimulation (P=0.021) and glucose reduction (P=0.001) were greater in females than males, while no sex-associated effects were found for cholecystokinin, peptide YY, GLP-1, glucagon, or pyloric pressures. Conclusion: ID quinine has greater effects on plasma gut and pancreatic hormones and pyloric pressures than IG quinine in healthy subjects, consistent with the concept that stimulation of small intestinal bitter receptors is critical to these responses. Both insulin stimulation and glucose lowering were sex-dependent.

Published
2022

41. Patient Acceptability of a Novel Technological Solution (Ambient Intelligent Geriatric Management System) to Prevent Falls in Geriatric and General Medicine Wards: A Mixed-Methods Study

Author

Dollard, Joanne, primary, Hill, Keith D., additional, Wilson, Anne, additional, Ranasinghe, Damith C., additional, Lange, Kylie, additional, Jones, Katherine, additional, Boyle, Eileen Mary, additional, Zhou, Mengqi, additional, Ng, Nicholas, additional, and Visvanathan, Renuka, additional

Published
2022
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46. Gastric emptying measurement of liquid nutrients using the .sup.13C-octanoate breath test in critically ill patients: a comparison with scintigraphy

Author

Nguyen, Nam Q., Bryant, Laura K., Burgstad, Carly M., Chapman, Marianne, Deane, Adam, Bellon, Max, and Lange, Kylie

Subjects
General Electric Co., Medical research -- Analysis, Medicine, Experimental -- Analysis, Radiation -- Analysis, Health care industry
Abstract

Purpose Scintigraphy is considered the most accurate technique for the measurement of gastric emptying (GE) but, for patients in the intensive care unit, it is technically demanding, involves radiation and can interfere with care. The .sup.13C-octanoate breath test (.sup.13C-OBT) is a simple, non-invasive technique that does not involve radiation exposure. Aim To evaluate the performance of the .sup.13C-OBT in the assessment of GE in critically ill patients. Methods The GE was assessed in 33 mechanically ventilated patients (23 M; 54.3 ± 3.0 yrs; APACHE II: 22.0 ± 1.1). Following test meal administration (100 ml Ensure.sup.®), concurrent scintigraphic measurement and breath samples (.sup.13C-OBT) were collected over 4 h. Scintigraphic meal retention was determined and the gastric emptying coefficient (GEC) and half emptying time [t50.sub.(BT)] were calculated for the .sup.13C-OBT. Delayed GE was defined as meal retention >13 % at 180 min. Results Delayed GE was identified in 27/33 patients. Meal retention correlated modestly with t50.sub.(BT) (r = 0.55-0.66; P < 0.001) and well with GEC (r = -0.63 to -0.74; P < 0.0001). The strength of agreement between the two techniques was highest between GEC and retention at 120 min. The best cut-off GEC for defining delayed GE was 3.25 (AUC = 0.75; 95 % CI = 0.52-0.99; P = 0.05), with 89 % sensitivity and 67 % specificity to detect delayed GE. The GE was delayed in all (23/23) patients with feed intolerance (GRV > 250 ml) on scintigraphy and 91 % (21/23) patients on .sup.13C-OBT. Conclusion In critical illness, there was a correlation between .sup.13C-OBT and gastric scintigraphy, with GEC performing as a better and more sensitive marker of detecting delayed GE than t50. However the relatively wide 95 % confidence intervals suggest that .sup.13C-OBT is more suitable as a technique to assess GE in a group setting for research studies rather than for individual patients in clinical practice., Author(s): Nam Q. Nguyen [sup.1] [sup.2], Laura K. Bryant [sup.1], Carly M. Burgstad [sup.1], Marianne Chapman [sup.2] [sup.3], Adam Deane [sup.2] [sup.3], Max Bellon [sup.4], Kylie Lange [sup.2], Dylan Bartholomeuz [...]

Published
2013
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48. Effectiveness of the Wearable Sensor-based Ambient Intelligent Geriatric Management (AmbIGeM) System in Preventing Falls in Older People in Hospitals

Author

Visvanathan, Renuka, primary, Ranasinghe, Damith C, additional, Lange, Kylie, additional, Wilson, Anne, additional, Dollard, Joanne, additional, Boyle, Eileen, additional, Jones, Katherine, additional, Chesser, Michael, additional, Ingram, Katharine, additional, Hoskins, Stephen, additional, Pham, Clarabelle, additional, Karnon, Jonathan, additional, and Hill, Keith D, additional

Published
2021
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