Corrigendum to “Preventing severe hypoglycemia in adults with type 2 diabetes (PHT2): Design, delivery and evaluation framework for a randomized controlled trial” [Contemp Clin Trials 2024 Apr:139:107456, pgs 1–11] (Contemporary Clinical Trials (2024) 139, (S1551714424000302), (10.1016/j.cct.2024.107456))
Year: 2025
Type: erratum
Abstract: © 2024 Elsevier Inc.We are requesting two corrigenda to the published paper: 1. The authors regret there was an error in the description of the analytic methods for the primary outcome. In section 2.10, the last sentence of the first paragraph states, “Models will be fit using generalized estimating equations (GEE) and robust variance estimation to account for correlation due to patient clustering in clinics and the misspecified mean-variance relationship in using Poisson regression for a binary outcome.” This sentence should read, “Models will be fit using generalized estimating equations (GEE) and robust variance estimation to account for correlation due to patient clustering in the intervention arm within group training session cohorts, and the misspecified mean-variance relationship in using Poisson regression for a binary outcome.” The original trial design was a cluster randomized trial, with randomization at the clinic level. The original text was based on the cluster randomized design, and this methodology would have been appropriate because training cohorts would have been nested within clinics. Unfortunately, this text was not corrected when the trial switched to an individual level randomization due to a change in how the delivery system structured diabetes care. 2. The authors regret there was an error in one of the values describing the power to detect a difference in the study's primary outcome. In section 2.11, the sentence reads, “Assuming 60% of participants in the Proactive Care Management group self-report a severe hypoglycemia event in 12-month look-back, a trial with 204 participants (102 per group) will have 90% power to detect a 26.6% absolute difference between groups (i.e., 37.4% severe hypoglycemia rate in the my hypo compass arm) and 80% power for a 19.7% difference for the primary outcome”. This sentence should read, “Assuming 60% of participants in the Proactive Care Management group self-report a severe hypoglycemia event in 12-month look-back, a trial with 204 participants (102 per group) will have 90% power to detect a 22.6% absolute difference between groups (i.e., 37.4% severe hypoglycemia rate in the my hypo compass arm) and 80% power for a 19.7% difference for the primary outcome.” The authors would like to apologise for any inconvenience caused.
Source: Figshare
Authors: James D. Ralston, Melissa Anderson, Janet Ng, Ayat Bashir, Kelly Ehrlich, Dena Burns-Hunt, Meredith Cotton, Laurel Hansell, Clarissa Hsu, Helen Hunt, Andrew J. Karter, Shaula M. Levy, Evette Ludman, Lawrence Madziwa, Emily M. Omura, Kristine Rogers, Brandie Sevey, James Shaw, Susan M. Shortreed, Umesh Singh, Jane Speight, Amber Sweeny, Katherine Tschernisch, S. Sergei Tschernisch, Laura Yarborough
Institution: Newcastle University
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6980823960
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