Statistical Analysis Plan for RECITAL: a non-inferiority randomised control trial evaluating a virtual fracture clinic compared with in-person care for people with simple fractures

2The Fracture Clinic Trial (RECITAL) is a prospective two-arm, parallel-group randomised controlled trial, using a non-inferiority design with nested economic and process evaluations. It aims to determine whether virtual care produces non-inferior physical function outcomes compared to in-person care for patients with simple fractures at 12-week follow-up, measured using the Patient-Specific Functional Scale (PSFS). This statistical analysis plan pre-specifies the method of analysis for every outcome and key variable collected in the trial. The primary outcome is physical function measured using the PSFS at 12 weeks. A higher score indicates the patient has better function. The PSFS score at 12 weeks will be compared between treatment groups in a generalised linear mixed model. The non-inferiority margin was pre-specified as a mean difference of 0.7 points less on the 0-10 scale PSFS; thus, non-inferiority will be declared if the lower bound of the 95% confidence interval around the mean difference is higher than -0.7. The primary analysis will be based on an intention-to-treat dataset. The analysis plan also includes planned sensitivity analyses, including covariate adjustments and subgroup analyses. 4 Administrative information4.1 Study identifiersProtocol publication: Teng MJ, Zadro JR, Pickles K, et al. RECITAL: a non-inferiority randomised control trial evaluating a virtual fracture clinic compared with in-person care for people with simple fractures (study protocol). BMJ Open 2024;14:e080800. doi:10.1136/bmjopen-2023-080800[1]. This study is prospectively registered on the Australian New Zealand Clinical Trials Registry (ANZCTR). Trial registration number ACTRN12623000934640. 4.2 Revision history O_TBL View this table: org.highwire.dtl.DTLVardef@afa071org.highwire.dtl.DTLVardef@4e75bcorg.highwire.dtl.DTLVardef@113c652org.highwire.dtl.DTLVardef@1413e5aorg.highwire.dtl.DTLVardef@64b898_HPS_FORMAT_FIGEXP M_TBL C_TBL 4.3 Contribution and approvals4.3.1 Contributors to the statistical analysis plan O_TBL View this table: org.highwire.dtl.DTLVardef@930462org.highwire.dtl.DTLVardef@4cfa9org.highwire.dtl.DTLVardef@1dd9285org.highwire.dtl.DTLVardef@1be6f3corg.highwire.dtl.DTLVardef@178d53d_HPS_FORMAT_FIGEXP M_TBL C_TBL 4.3.2 ApprovalsThe undersigned have reviewed this plan and approve it as final. They find it to be consistent with the requirements of the protocol as it applies to their respective areas. They also find it to be compliant with ICH-E9 principles and, in particular, confirm that this analysis plan was developed in a completely blinded manner (i.e. without knowledge of the effect of the intervention(s) being assessed). O_FIG O_LINKSMALLFIG WIDTH=200 HEIGHT=129 SRC="FIGDIR/small/25333243v1_ufig1.gif" ALT="Figure 1"> View larger version (14K): org.highwire.dtl.DTLVardef@1f7cff1org.highwire.dtl.DTLVardef@74e382org.highwire.dtl.DTLVardef@47338org.highwire.dtl.DTLVardef@286fe6_HPS_FORMAT_FIGEXP M_FIG C_FIG