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Background  Hand rehabilitation needs valid evaluation tools; the 400-point Hand Assessment (HA) is an exhaustive but not standardised tool. The aim of this study was to validate a standardised version of this test.    Methods  A modified version and a standardised prototype was made for this prospective validation study (four centres, three countries). Psychometric properties studied: reliability (intra-rater and inter-rater, standard error of measurement [SEM], minimum detectable change [MDC],internal consistency); content validity, construct validity with Jebsen Taylor hand function test, Q uick DASH, MOS-SF 36 and pain; responsiveness, using an anchor-based approach (ROC curve with area under curve, mean response change) with calculation of MCID. For SEM, MDC and responsiveness,  Quick DASH was used for comparison.    Results  One hundred and seventy-six patients with hand/wrist injuries were included between May 2013 and February 2015. One hundred and seventy were available for final analysis: 67% men; mean age 43.4 ± 13.2 years; both manual and office workers (46, 5% of each); 37% had a hand or wrist fracture.   Reliability:  ICC intra-rater = 0.967 [0.938–0.982]; inter-rater = 0.868 [0.754–0.932]. Distribution-based approach: for 400-point HA/Q uick DASH: SEM = 3.48/4.52, MDC = 9.065/12.53, internal consistency of 400-point HA: Cronbach α = 0.886.   Validity:  Content validity was good according to COSMIN guidelines. Construct validity: correlation coefficient: Jebsen-Taylor hand function test = − 0.573 [− 0.666–0.464], Q uick DASH = − 0.432 at T0 [− 0.545–0.303], − 0.551 at T3 [− 0.648–0.436]; MOS-SF 36 physical component = 0.395 [0.263–0.513]; no correlation with MOS-SF 36 mental component = 0.142 [− 0.009 + 0.286] and pain = − 0.166 [− 0.306 + 0.018].   Responsiveness:  Anchor-based approach: AUC Δ400-point HA = 0.666 [0.583–0.749], AUC ΔQ uick DASH = 0.556 [0.466–0.646]. MCID (optimal ROC curve cut-off): 6.07 for 400-point HA, − 2.27 for Q uick DASH. MCID with mean response change + 12.034 ± 9.067 for 400-point HA and − 8.03 ± –9.7 for Q uick DASH. The patient’s global impression of change was only correlated with the Δ400-point HA.    Conclusions  The 400-point HA standardised version has good psychometric properties. For responsiveness, we propose an MCID of at least 12.3/100. However, these results must be confirmed in other populations and pathologies.    Trial registration  This study was retrospectively registered into ISCTRN registry (Number  ISRCTN25874481 ) the 07/02/2019.

Prospective multicentre validation study of a new standardised version of the 400-point hand assessment