Development , validation , and incorporation of a small number of disease-specific patient-based instruments will improve the quality of research and care of CM-I patients
OBJECT Chiari malformation Type I ( CM-I ) is a common and often debilitating neurological disease .
Efforts to improve treatment of CM-I are impeded by inconsistent and limited methods of evaluating clinical outcomes .
Accurately measuring outcomes after surgery for adult Chiari I malformation: determining the most valid and responsive instruments.
BACKGROUND There has been a transition to using patient-reported outcome instruments ( PROi ) to assess surgical effectiveness . However , none of these instruments have been vali date d for outcomes of adult Chiari I malformation ( CMI ) . OBJECTIVE The aim of this study was to determine the relative validity and responsiveness of various PROi in measuring outcomes after surgery for CMI . METHODS Fifty patients undergoing suboccipital craniotomy for adult CMI were prospect ively followed for 1 year . Baseline and 1-year patient-reported outcomes ( visual analog scale for head pain and visual analog scale for neck pain , Neck Disability Index [ NDI ] , Headache Disability Index , SF-12 , Zung Self-Rating Depression Scale , and EuroQol-5D [ EQ-5D ] ) were assessed . A level of improvement in general health after surgery was defined as meaningful improvement . Receiver-operating characteristic curves were generated to assess the validity of PROi to discriminate between meaningful improvement and not . The difference between st and ardized response means ( SRMs ) in patients reporting meaningful improvement vs not as calculated to determine the relative responsiveness of each outcome instrument . RESULTS For pain and disability , the NDI was the most accurate discriminator of meaningful effectiveness ( area under the curve : 0.90 ) and also most responsive to postoperative improvement ( st and ardized response means difference : 1.87 ) . For general health and quality of life , the SF-12 PCS , EQ-5D , and Zung Self-Rating Depression Scale were all accurate discriminators ; however , SF-12 Physical Component Scale ( SF-12 PCS ) and EQ-5D were most accurate . SF-12 PCS was also most responsive . CONCLUSION For pain and disability , NDI is the most valid and responsive measure of improvement after surgery for CMI . For health-related quality of life , SF-12 PCS and EQ-5D are the most valid and responsive measures . NDI with SF-12 or EQ-5D is the most valid in patients with CMI and should be considered in cost-effectiveness studies
Development , validation , and incorporation of a small number of disease-specific patient-based instruments will improve the quality of research and care of CM-I patients
OBJECT Chiari malformation Type I ( CM-I ) is a common and often debilitating neurological disease .
Efforts to improve treatment of CM-I are impeded by inconsistent and limited methods of evaluating clinical outcomes .