Navigating the consent river: questions to consider before waiving consent requirements in pragmatic cluster randomised trials.

The robust design and conduct of pragmatic cluster randomised trials may be in tension with the ethical requirement to obtain written informed consent from prospective research participants. In our experience, researchers tend to focus on whether a waiver of consent is appropriate for their studies. However, pragmatic cluster randomised trials raise other important questions that have direct implications for determining when an alteration or waiver of consent is permissible.

Kidney Function and Body Composition in Adult Survivors of Unilateral, Non-Syndromic Wilms Tumor: A Report From the St. Jude Lifetime Cohort Study.

Background: The relationships among treatment exposures, body composition, and estimated glomerular filtration rate (eGFR) in adult survivors of Wilms tumor have not been well studied.

Methods: We evaluated body composition with dual-energy x-ray absorptiometry (DXA) and eGFR with the updated Chronic Kidney Disease Epidemiology Collaboration equations (creatinine only-eGFR, cystatin C only-eGFR, creatinine and cystatin C-eGFR) without race in 134 adults previously treated for unilateral, non-syndromic Wilms tumor at St. Jude Children's Research Hospital between 1964 and 2004 with chemotherapy and with (hemiabdomen [HA] or whole abdomen [WA]) or without radiation therapy (RT).

Profiling mRNA encoding glucocorticoid receptor α in saliva: Relationship to hair cortisol levels in individuals aged 15-25 years.

Objective: We assessed levels of mRNA encoding two glucocorticoid receptor (GR) isoforms (GRα and GRβ) in saliva and examined their relationship with hair cortisol levels and dental caries experience.

Design: Adolescents and young adults were assessed for dental caries experience, and hair cortisol was measured by ELISA. RNA was extracted from whole saliva using TRIzol, followed by quantitative real-time PCR analysis of GRα, GRβ, and glyceraldehyde 3-phosphate dehydrogenase (GAPDH).

Randomized Trials Using Provincial Health Numbers for Group Assignment.

Purpose: Using data from Ontario, Canada, this report shows how provincial government-assigned health card numbers can be used for individual-level randomization in large pragmatic trials. We describe how health card numbers are assigned and analyze the distribution of health card digits in a trial setting. We then provide an example of how they can be used for randomization and discuss the methodological and practical considerations of the approach.