This included examination of the hypothesized scale structure of the questionnaire, internal consistency reliability estimation, known groups validity testing, and evaluation of the responsiveness of the QLQ-BN20 to changes over time in health status.
Furthermore, this was a non-prospectively randomized study, and the evaluation of responsiveness to sorafenib may have been incomplete due to the involvement of different institutions.
Third, this study examined reliability and validity through a cross-sectional study only, and thus requires further evaluation of responsiveness before and after intervention and in longitudinal studies.
Despite the ordinal nature of FIM + FAM data, parametric and non-parametric evaluation of responsiveness in this large dataset gave very similar results.
TQs facilitate evaluation of responsiveness and minimal important change (MIC) thresholds for PROMs, through being used as 'anchors' – that is to say, the PROM scores of those responding in a particular category of the TQ are categorised for analysis, and then used to dichotomise PROM score improvements; in Receiver Operator Characteristic (ROC) curves for example [ 7].
Here, we report the evaluation of responsiveness (change between admission and discharge) within the various subscales using paired t tests.
Recent reviews of measures of foot function, foot health and foot pain indicate that few have undergone adequate evaluation of responsiveness, thereby limiting their use in clinical trials [ 6- 11].
In addition, tables are well organized to illustrate decision making on hypovolaemia, assessment of fluid responsiveness and evaluation of ventricular function.
As we employed the transition question of the SF-36 which covers the change in health compared to one year before, the evaluation of responsiveness focussed on the period between t0 and t2.
Given the increasing use of the FHSQ and MFPDI in foot and ankle research, there is a need for a more detailed evaluation of responsiveness of these instruments in order to determine whether it is appropriate to employ them as outcome measures in clinical trials of interventions for foot disorders.
