Browsing by Author "McCabe, Christopher"
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Item Open Access A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan(2020-08-24) Heath, Anna; Rios, Juan David; Williamson-Urquhart, Sarah; Pechlivanoglou, Petros; Offringa, Martin; McCabe, Christopher; Hopkin, Gareth; Plint, Amy C; Dixon, Andrew; Beer, Darcy; Gouin, Serge; Joubert, Gary; Klassen, Terry P; Freedman, Stephen BAbstract Background Acute gastroenteritis is a leading cause of emergency department visits and hospitalizations among children in North America. Oral-rehydration therapy is recommended for children with mild-to-moderate dehydration, but children who present with vomiting are frequently offered intravenous rehydration in the emergency department (ED). Recent studies have demonstrated that the anti-emetic ondansetron can reduce vomiting, intravenous rehydration, and hospitalization when administered in the ED to children with dehydration. However, there is little evidence of additional benefit from prescribing ondansetron beyond the initial ED dose. Moreover, repeat dosing may increase the frequency of diarrhea. Despite the lack of evidence and potential adverse side effects, many physicians across North America provide multiple doses of ondansetron to be taken following ED disposition. Thus, the Multi-Dose Oral Ondansetron for Pediatric Gastroenteritis (DOSE-AGE) trial will evaluate the effectiveness of prescribing multiple doses of ondansetron to treat acute gastroenteritis-associated vomiting. This article specifies the statistical analysis plan (SAP) for the DOSE-AGE trial and was submitted before the outcomes of the study were available for analysis. Methods/design The DOSE-AGE study is a phase III, 6-center, placebo-controlled, double-blind, parallel design randomized controlled trial designed to determine whether participants who are prescribed multiple doses of oral ondansetron to administer, as needed, following their ED visit have a lower incidence of experiencing moderate-to-severe gastroenteritis, as measured by the Modified Vesikari Scale score, compared with a placebo. To assess safety, the DOSE-AGE trial will investigate the frequency and maximum number of diarrheal episodes following ED disposition, and the occurrence of palpitations, pre-syncope/syncope, chest pain, arrhythmias, and serious adverse events. For the secondary outcomes, the DOSE-AGE trial will investigate the individual elements of the Modified Vesikari Scale score and caregiver satisfaction with the therapy. Discussion The DOSE-AGE trial will provide evidence on the effectiveness of multiple doses of oral ondansetron, taken as needed, following an initial ED dose in children with acute gastroenteritis-associated vomiting. The data from the DOSE-AGE trial will be analyzed using this SAP. This will reduce the risk of producing data-driven results and bias in our reported outcomes. The DOSE-AGE study was registered on ClinicalTrials.gov on February 22, 2019. Trial registration ClinicalTrials.gov NCT03851835 . Registered on 22 February 2019.Item Open Access Impact of an addiction medicine consult team intervention in a Canadian inner city hospital on acute care utilization: a pragmatic quasi-experimental study(2022-03-12) Salvalaggio, Ginetta; Dong, Kathryn A.; Hyshka, Elaine; McCabe, Christopher; Nixon, Lara; Rosychuk, Rhonda J.; Dmitrienko, Klaudia; Krajnak, Judith; Mrklas, Kelly; Wild, T. C.Abstract Background Inner city patients have a higher illness burden and need for care, but experience more unmet care needs. Hospital Addiction Medicine Consult Teams (AMCTs) are a promising emerging intervention. The objective of this study was to assess the impact of a Canadian AMCT-like intervention for inner city patients on reduction in high emergency department (ED) use, hospital admission, and inpatient length of stay. Methods Using a community-engaged, two-arm, pre-post, longitudinal quasi-experimental study design, 572 patients reporting active substance use, unstable housing, unstable income, or a combination thereof (302 at intervention site, 270 at control sites) were enrolled. Survey and administrative health service data were collected at baseline, six months post-enrolment, and 12 months post-enrolment. Multivariable regression models tested the intervention effect, adjusting for clinically important covariables (inpatient status at enrolment, medical complexity, age, gender, Indigenous identity, shelter use, opioid use). Results Initial bivariable analyses demonstrated an intervention effect on reduction in admissions and length of stay, however, this effect was no longer significant after adjusting for covariables. There was no evidence of reduction in high ED use on either bivariable or subsequent multivariable analysis. Conclusions After adjusting for covariables, no AMCT intervention effect was detected for reduction in high ED use, inpatient admission, or hospital length of stay. Further research is recommended to assess other patient-oriented intervention outcomes.Item Open Access Interventions on gender equity in the workplace: a scoping review(2024-04-05) Tricco, Andrea C.; Parker, Amanda; Khan, Paul A.; Nincic, Vera; Robson, Reid; MacDonald, Heather; Warren, Rachel; Cleary, Olga; Zibrowski, Elaine; Baxter, Nancy; Burns, Karen E. A.; Coyle, Doug; Ndjaboue, Ruth; Clark, Jocalyn P.; Langlois, Etienne V.; Ahmed, Sofia B.; Witteman, Holly O.; Graham, Ian D.; El-Adhami, Wafa; Skidmore, Becky; Légaré, France; Curran, Janet; Hawker, Gillian; Watt, Jennifer; Bourgeault, Ivy L.; Leigh, Jeanna P.; Lawford, Karen; Aiken, Alice; McCabe, Christopher; Shepperd, Sasha; Pattani, Reena; Leon, Natalie; Lundine, Jamie; Adisso, Évèhouénou L.; Ono, Santa; Rabeneck, Linda; Straus, Sharon E.Abstract Background Various studies have demonstrated gender disparities in workplace settings and the need for further intervention. This study identifies and examines evidence from randomized controlled trials (RCTs) on interventions examining gender equity in workplace or volunteer settings. An additional aim was to determine whether interventions considered intersection of gender and other variables, including PROGRESS-Plus equity variables (e.g., race/ethnicity). Methods Scoping review conducted using the JBI guide. Literature was searched in MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, ERIC, Index to Legal Periodicals and Books, PAIS Index, Policy Index File, and the Canadian Business & Current Affairs Database from inception to May 9, 2022, with an updated search on October 17, 2022. Results were reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension to scoping reviews (PRISMA-ScR), Sex and Gender Equity in Research (SAGER) guidance, Strengthening the Integration of Intersectionality Theory in Health Inequality Analysis (SIITHIA) checklist, and Guidance for Reporting Involvement of Patients and the Public (GRIPP) version 2 checklist. All employment or volunteer sectors settings were included. Included interventions were designed to promote workplace gender equity that targeted: (a) individuals, (b) organizations, or (c) systems. Any comparator was eligible. Outcomes measures included any gender equity related outcome, whether it was measuring intervention effectiveness (as defined by included studies) or implementation. Data analyses were descriptive in nature. As recommended in the JBI guide to scoping reviews, only high-level content analysis was conducted to categorize the interventions, which were reported using a previously published framework. Results We screened 8855 citations, 803 grey literature sources, and 663 full-text articles, resulting in 24 unique RCTs and one companion report that met inclusion criteria. Most studies (91.7%) failed to report how they established sex or gender. Twenty-three of 24 (95.8%) studies reported at least one PROGRESS-Plus variable: typically sex or gender or occupation. Two RCTs (8.3%) identified a non-binary gender identity. None of the RCTs reported on relationships between gender and other characteristics (e.g., disability, age, etc.). We identified 24 gender equity promoting interventions in the workplace that were evaluated and categorized into one or more of the following themes: (i) quantifying gender impacts; (ii) behavioural or systemic changes; (iii) career flexibility; (iv) increased visibility, recognition, and representation; (v) creating opportunities for development, mentorship, and sponsorship; and (vi) financial support. Of these interventions, 20/24 (83.3%) had positive conclusion statements for their primary outcomes (e.g., improved academic productivity, increased self-esteem) across heterogeneous outcomes. Conclusions There is a paucity of literature on interventions to promote workplace gender equity. While some interventions elicited positive conclusions across a variety of outcomes, standardized outcome measures considering specific contexts and cultures are required. Few PROGRESS-Plus items were reported. Non-binary gender identities and issues related to intersectionality were not adequately considered. Future research should provide consistent and contemporary definitions of gender and sex. Trial registration Open Science Framework https://osf.io/x8yae .Item Open Access Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial(2020-05-27) Freedman, Stephen B; Williamson-Urquhart, Sarah; Heath, Anna; Pechlivanoglou, Petros; Hopkin, Gareth; Gouin, Serge; Plint, Amy C; Dixon, Andrew; Beer, Darcy; Joubert, Gary; McCabe, Christopher; Finkelstein, Yaron; Klassen, Terry P.Abstract Background There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency department to promote oral rehydration therapy success. However, clinicians are also increasingly providing multiple doses of ondansetron for home use, creating unquantified cost and health system resource use implications without any evidence to support this expanding practice. Methods/design DOSE-AGE is a randomized, placebo-controlled, double-blinded, six-center, pragmatic clinical trial being conducted in six Canadian pediatric emergency departments (EDs). In September 2019 the study began recruiting children aged 6 months to 18 years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72 h of gastroenteritis symptoms and who were administered a dose of ondansetron during their ED visit. We are recruiting 1030 children (1:1 allocation via an internet-based, third-party, randomization service) to receive a 48-h supply (i.e., six doses) of ondansetron oral solution or placebo, administered on an as-needed basis. All participants, caregivers and outcome assessors will be blinded to group assignment. Outcome data will be collected by surveys administered to caregivers 24, 48 and 168 h following enrollment. The primary outcome is the development of moderate-to-severe gastroenteritis in the 7 days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale). Secondary outcomes include duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety. A preplanned economic evaluation will be conducted alongside the trial. Discussion Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis. Usage is increasing, despite the absence of supportive evidence. The incumbent additional costs associated with use, and potential side effects such as diarrhea and repeat visits, create an urgent need to evaluate the effect and safety of multiple doses of ondansetron in children focusing on post-emergency department visit and patient-centered outcomes. Trial Registration ClinicalTrials.gov: NCT03851835. Registered on 22 February 2019.Item Open Access PSMA PET/CT guided intensification of therapy in patients at risk of advanced prostate cancer (PATRON): a pragmatic phase III randomized controlled trial(2022-03-08) Ménard, Cynthia; Young, Sympascho; Zukotynski, Katherine; Hamilton, Robert J.; Bénard, François; Yip, Steven; McCabe, Christopher; Saad, Fred; Brundage, Michael; Nitulescu, Roy; Bauman, GlennAbstract Background Positron emission tomography targeting the prostate specific membrane antigen (PSMA PET/CT) has demonstrated unparalleled performance as a staging examination for prostate cancer resulting in substantial changes in management. However, the impact of altered management on patient outcomes is largely unknown. This study aims to assess the impact of intensified radiotherapy or surgery guided by PSMA PET/CT in patients at risk of advanced prostate cancer. Methods This pan-Canadian phase III randomized controlled trial will enroll 776 men with either untreated high risk prostate cancer (CAPRA score 6–10 or stage cN1) or biochemically recurrent prostate cancer post radical prostatectomy (PSA > 0.1 ng/mL). Patients will be randomized 1:1 to either receive conventional imaging or conventional plus PSMA PET imaging, with intensification of radiotherapy or surgery to newly identified disease sites. The primary endpoint is failure free survival at 5 years. Secondary endpoints include rates of adverse events, time to next-line therapy, as well as impact on health-related quality of life and cost effectiveness as measured by incremental cost per Quality Adjusted Life Years gained. Discussion This study will help create level 1 evidence needed to demonstrate whether or not intensification of radiotherapy or surgery based on PSMA PET findings improves outcomes of patients at risk of advanced prostate cancer in a manner that is cost-effective. Trial registration This trial was prospectively registered in ClinicalTrials.gov as NCT04557501 on September 21, 2020.Item Open Access Reducing readmission rates for individuals discharged from acute psychiatric care in Alberta using peer and text message support: Protocol for an innovative supportive program(2022-03-12) Eboreime, Ejemai; Shalaby, Reham; Mao, Wanying; Owusu, Ernest; Vuong, Wesley; Surood, Shireen; Bales, Kerry; MacMaster, Frank P.; McNeil, Diane; Rittenbach, Katherine; Ohinmaa, Arto; Bremault-Phillips, Suzette; Hilario, Carla; Greiner, Russ; Knox, Michelle; Chafe, Janet; Coulombe, Jeff; Xin-Min, Li; McLean, Carla; Rathwell, Rebecca; Snaterse, Mark; Spurvey, Pamela; Taylor, Valerie H.; McLean, Susan; Urichuk, Liana; Tzeggai, Berhe; McCabe, Christopher; Grauwiler, David; Jordan, Sara; Brown, Ed; Fors, Lindy; Savard, Tyla; Grunau, Mara; Kelton, Frank; Stauffer, Sheila; Cao, Bo; Chue, Pierre; Abba-Aji, Adam; Silverstone, Peter; Nwachukwu, Izu; Greenshaw, Andrew; Agyapong, Vincent I. O.Abstract Background Individuals discharged from inpatient psychiatry units have the highest readmission rates of all hospitalized patients. These readmissions are often due to unmet need for mental health care compounded by limited human resources. Reducing the need for hospital admissions by providing alternative effective care will mitigate the strain on the healthcare system and for people with mental illnesses and their relatives. We propose implementation and evaluation of an innovative program which augments Mental Health Peer Support with an evidence-based supportive text messaging program developed using the principles of cognitive behavioral therapy. Methods A pragmatic stepped-wedge cluster-randomized trial, where daily supportive text messages (Text4Support) and mental health peer support are the interventions, will be employed. We anticipate recruiting 10,000 participants at the point of their discharge from 9 acute care psychiatry sites and day hospitals across four cities in Alberta. The primary outcome measure will be the number of psychiatric readmissions within 30 days of discharge. We will also evaluate implementation outcomes such as reach, acceptability, fidelity, and sustainability. Our study will be guided by the Consolidated Framework for Implementation Research, and the Reach-Effectiveness-Adoption-Implementation-Maintenance framework. Data will be extracted from administrative data, surveys, and qualitative methods. Quantitative data will be analysed using machine learning. Qualitative interviews will be transcribed and analyzed thematically using both inductive and deductive approaches. Conclusions To our knowledge, this will be the first large-scale clinical trial to assess the impact of a daily supportive text message program with and without mental health peer support for individuals discharged from acute psychiatric care. We anticipate that the interventions will generate significant cost-savings by reducing readmissions, while improving access to quality community mental healthcare and reducing demand for acute care. It is envisaged that the results will shed light on the effectiveness, as well as contextual barriers and facilitators to implementation of automated supportive text message and mental health peer support interventions to reduce the psychological treatment and support gap for patients who have been discharged from acute psychiatric care. Trial registration clinicaltrials.gov, NCT05133726 . Registered 24 November 2021