NCT05358522 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hemming K, Taljaard M, Forbes A
Analysis of cluster randomised stepped wedge trials with repeated cross-sectional samples. Trials. 2017 Mar 4;18(1):101. doi: 10.1186/s13063-017-1833-7.
Hogan JW, Lancaster T
Instrumental variables and inverse probability weighting for causal inference from longitudinal observational studies. Stat Methods Med Res. 2004 Feb;13(1):17-48. doi: 10.1191/0962280204sm351ra.
Hussey MA, Hughes JP
Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
Starks MA, Sanders GD, Coeytaux RR, Riley IL, Jackson LR 2nd, Brooks AM, Thomas KL, Choudhury KR, Califf RM, Hernandez AF
Assessing heterogeneity of treatment effect analyses in health-related cluster randomized trials: A systematic review. PLoS One. 2019 Aug 12;14(8):e0219894. doi: 10.1371/journal.pone.0219894. eCollection 2019.
White H
A Heteroskedasticity-Consistent Covariance-Matrix Estimator and a Direct Test for Heteroskedasticity. Econometrica 1980;48:817-38.
Zeger SL, Liang KY
Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 1986 Mar;42(1):121-30.

Learning Health System Clinician Feedback Using Patient-reported Data to Increase Implementation of Post-operative Opioid Prescribing Guidelines: a Stepped-wedge Cluster Randomized Trial

Details for clinical trial NCT05358522

Clinical trial NCT05358522 - References