Exemplar Trial Intro - MyTEMP. (2-min video)

• Summary: Dr. Amit Garg introduces the exemplar MyTEMP pragmatic trial and the curriculum wheel.

Exemplar Trial Overview - MyTEMP. (12-min video & 20-slide presentation)

• Summary: Dr. Amit Garg overviews MyTEMP, a pragmatic, two-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority trial done at hemodialysis centres. This trial assessed whether personalized cooler dialysate, implemented as a centre-wide policy, reduced the risk of cardiovascular-related death or hospital admission compared with standard temperature dialysate.

MyTEMP writing committee. Personalised cooler dialysate for patients receiving maintenance haemodialysis (MyTEMP): a pragmatic, cluster-randomised trial. Lancet. 2022 Nov 12;400(10364):1693-1703. (11-page paper) * An institutional login (e.g., university or research institute e-mail address) is required to access this material. 

• Summary: Publication in The Lancet describing the MyTEMP pragmatic trial, which aimed to establish whether delivering maintenance hemodialysis with a centre-wide policy of personalized cooler dialysate is superior to standard temperature dialysate in reducing the risk of cardiovascular-related death or hospital admission with myocardial infarction, ischemic stroke, or congestive heart failure.

Exemplar Trial - MyTEMP. (18-min video & 26-slide presentation)

• Summary: Dr. Amit Garg breaks down the MyTEMP trial across the sections of the curriculum wheel.

Garg AX, et al. Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP). ClinicalTrials.gov identifier: NCT02628366. Updated 2023-06-29. (8-section website)

• Summary: Public registration of the trial (i.e., study overview, contacts and locations, study plan, collaborators and investigators, publications, study record dates). 

Al-Jaishi AA, et al. Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP): Rationale and Design of a Pragmatic, Registry-Based, Cluster Randomized Controlled Trial. Can J Kidney Health Dis. 2020 Feb 5;7:2054358119887988. (18-page paper)

• Summary: Trial protocol describing the Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP) trial.

Dixon SN, et al. MyTEMP: Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial. Can J Kidney Health Dis. 2021 Aug 27;8:20543581211041182. Erratum in: Can J Kidney Health Dis. 2022 Jul 6;9:20543581221110098. (11-page paper)

• Summary: Prespecified statistical analysis plan for the MyTEMP trial. i.e., The primary analysis followed an intent-to-treat approach, and the primary outcome was analyzed at the patient-level as the hazard ratio of time-to-first event, estimated from a sub-distribution hazards model. Within-centre correlation was accounted for using a robust sandwich estimator and the between-group difference in the mean drop in intradialytic systolic blood pressure (obtained during the dialysis sessions throughout the trial period) was analyzed at the centre-level using an unadjusted random-effects linear mixed model.

Al-Jaishi AA, et al. Simple compared to covariate-constrained randomization methods in balancing baseline characteristics: a case study of randomly allocating 72 hemodialysis centers in a cluster trial. Trials. 2021 Sep 15;22(1):626. (13-page paper)

• Summary: A study exploring the covariate-constrained randomization approach used in the MyTEMP trial. i.e., In a mock-trial-scenario with 72 clusters, constraining the randomization using historical information achieved better balance on baseline characteristics compared with simple randomization. However, the magnitude of benefit was modest.

Al-Jaishi AA, et al. Health Services Use and Outcomes for Hospital Admissions With a Major Cardiovascular Event Recorded in Health Care Administrative Data in Patients Receiving Maintenance Hemodialysis: A Retrospective Cohort Study. Can J Kidney Health Dis. 2023 Apr 13;10:20543581231165708. (9-page paper)

• Summary: An observational study illustrating the importance of the primary outcome in the MyTEMP trial. Specifically, in patients receiving maintenance hemodialysis, hospital admissions of major cardiovascular events routinely recorded in health administrative databases were associated with significant use of health service resources and poor health outcomes.

Presseau J, et al. Barriers and facilitators to healthcare professional behaviour change in clinical trials using the Theoretical Domains Framework: a case study of a trial of individualized temperature-reduced haemodialysis. Trials. 2017 May 22;18(1):227. (16-page paper)

• Summary: To inform intervention implementation in the MyTEMP trial across many hemodialysis centres, this study assessed hemodialysis physicians’ and nurses’ perceived barriers and enablers to individualized dialysis temperature use.

Ward JM, e al. Patient and caregiver involvement in a multicentre clustered hemodialysis trial. CMAJ. 2018 Nov 7;190(Suppl):S32-S33. (2-page paper)

• Summary: A commentary highlighting patient and caregiver involvement in the MyTEMP trial, overviewing aspects related to, e.g., altered patient consent, research ethics board considerations, assessment of patient and caregiver perspectives related to the risk of the intervention, and considerations when engaging participants who are living with a condition associated with poor quality of life and lower life expectancy.

Mustafa RA, et al. Effect of Lowering the Dialysate Temperature in Chronic Hemodialysis: A Systematic Review and Meta-Analysis. Clin J Am Soc Nephrol. 2016 Mar 7;11(3):442-57. (16-page paper)

• Summary: To summarize the evidence related to dialysate temperature, this systematic review and meta-analysis examined the reported benefits and harms of lower temperature dialysis. This earlier work (2016) illustrated that high–quality, large, multicentre, randomized trials were needed to determine whether reduced temperature dialysis affects patient mortality and major adverse cardiovascular events; this served as further justification for the MyTEMP trial (2022).