danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025Amazing summary (including the VA) and discussion of a complicated story. Congrats! #NephJC 380
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025Sometimes more lessons are learned from failures than successes. I've learned quite a bit from working through the challenges of this trial. #NephJC 1113
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025I would also add that the separation of 0.8 mg/dl is inflated by the baseline difference in phosphate (i.e., not all the result of the intervention). Also, the outcomes of all-cause mortality & hospitalization have substantial "noise." #NephJC 062
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025It was all randomized... however, the cluster-randomized portion of enrollment was likely biased. #NephJC 040
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025Correct. Electronic consent with educational materials and videos was mostly successful. The lack of dedicated coordinators- especially on-site coordinators- really left us vulnerable to events such as the pandemic and workforce turnover. #NephJC 165
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025The pivot to individual randomization was successful with regard to the reasons for the pivot: baseline phosphate narrowed substantially. Enrollment is a different story. #NephJC 041
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025Important to highlight the timing here. Enrollment was held for much of 2020 when the pandemic hit. The equally large (and lingering) challenge was the burden placed on the dialysis staff in the wake of the pandemic. This affects all aspects of trial without research staff. #NephJC 132
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025Enrollment? Yes. Opt-out consent would have led to incredible enrollment (see: TiME). However, this does not translate into fidelity of the intervention/phos separation (see: TiME). #NephJC 062
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025There is some hesitation to sign up for something you've been told is harmful... also hesitation on the part of the dialysis facility staff to approach select patients for this reason. #NephJC 273
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025This was not the intended design. The pivot to individual randomization was made to avoid the issues encountered with cluster randomization in this trial (namely post-randomization consent biasing enrollment). #NephJC 241
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025Correct- this (presumably) led to post-randomization bias. This was evident by difference in baseline phosphate (6.6 vs 5.7 mg/dl) and consent rates (38% vs 63%) for high vs low, respectively. #NephJC 261
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025Important design element here- HiLo obtained informed consent. Compare this to TiME, which was an opt-out consent for data collection (not the intervention). #NephJC 151
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025I also want to highlight that the HiLo PI was Myles Wolf (now at Cornell), and the trial leadership included Laura Dember (Penn), Tamara Isakova (NW), and Hrishikesh Chakraborty (DCRI). #NephJC 172
danieledmonston.bsky.social @danieledmonston.bsky.social · 06/08/2025My first post on Bluesky. Thanks for the invite, @hswapnil.medsky.social. I look forward to the discussion! COI: investigator on HiLo. #NephJC 4103
