Karthik Vishwanathan1, Shantanu Jain1,2, Amit Patel1. 1. Department of Orthopaedics, Pramukhswami Medical College, Karamsad 388325, India. 2. Department of Orthopaedics, Convenient Hospitals Limited, AB Road, LIG Square, Indore 452008, Madhya Pradesh, India.
Abstract
BACKGROUND: The Nottingham Clavicle Score (NCS) has been recently described for functional outcome assessment after injuries to clavicle and the Acromioclavicular joint. However; validity and responsiveness are context specific psychometric terms and the NCS has not been previously described in surgically treated clavicle shaft fractures. Aim of the present study was to investigate validity and responsiveness of the NCS in clavicle fractures treated with titanium flexible nailing. METHODS: This prospective study was undertaken on consecutively operated clavicle shaft fractures treated with titanium elastic nail from November 2013 to August 2016. Functional assessment using NCS was done at two and six months postoperatively. Construct validity was also evaluated by formulating the null hypothesis that there would be no difference in NCS at six months after open and closed reduction and in 15B1 and 15B2 fracture sub-types. The above two hypotheses were formulated based on previous studies that used Constant score and DASH score. Pre-specified hypothesis and results in accordance with the hypotheses suggest satisfactory construct validity. Responsiveness was evaluated using standardized response mean (SRM) and Effect size (ES). ES and SRM values ≥0.80 suggest satisfactory responsiveness. The proportion of patients having the least possible score of 0 points (floor effect) and the highest possible score of 100 points (ceiling effect) was evaluated at two and six months postoperatively. Floor and ceiling effect of <15% suggests satisfactory internal validity. RESULTS: Thirty six consecutively operated patients were included in the study. The NCS at two months and six months was 69.6 ± 9.6 and 87.2 ± 7.1 respectively. The NCS at six months after fixation was 88.7 ± 4.8 in closed reduction cohort and 84.7 ± 9.4 in the open reduction cohort and this difference was not significant (p = 0.1). The NCS at six months after fixation was 85.3 ± 8.3 in 15B1 clavicular fractures and 89.7 ± 4.0 in 15B2 clavicular shaft fractures and this difference was also not significant (p = 0.07). All results pertaining to construct validity were in accordance with our hypothesis thereby suggesting that NCS demonstrates satisfactory construct validity. The ES and SRM were 1.8 and 2.6 respectively. NCS showed no ceiling (0%) or floor effect (0%) at two and six months postoperatively thereby suggesting adequate internal validity of the NCS. CONCLUSION: NCS has satisfactory construct validity, internal validity and responsiveness in surgically treated clavicle shaft fractures with titanium elastic nailing.
BACKGROUND: The Nottingham Clavicle Score (NCS) has been recently described for functional outcome assessment after injuries to clavicle and the Acromioclavicular joint. However; validity and responsiveness are context specific psychometric terms and the NCS has not been previously described in surgically treated clavicle shaft fractures. Aim of the present study was to investigate validity and responsiveness of the NCS in clavicle fractures treated with titanium flexible nailing. METHODS: This prospective study was undertaken on consecutively operated clavicle shaft fractures treated with titanium elastic nail from November 2013 to August 2016. Functional assessment using NCS was done at two and six months postoperatively. Construct validity was also evaluated by formulating the null hypothesis that there would be no difference in NCS at six months after open and closed reduction and in 15B1 and 15B2 fracture sub-types. The above two hypotheses were formulated based on previous studies that used Constant score and DASH score. Pre-specified hypothesis and results in accordance with the hypotheses suggest satisfactory construct validity. Responsiveness was evaluated using standardized response mean (SRM) and Effect size (ES). ES and SRM values ≥0.80 suggest satisfactory responsiveness. The proportion of patients having the least possible score of 0 points (floor effect) and the highest possible score of 100 points (ceiling effect) was evaluated at two and six months postoperatively. Floor and ceiling effect of <15% suggests satisfactory internal validity. RESULTS: Thirty six consecutively operated patients were included in the study. The NCS at two months and six months was 69.6 ± 9.6 and 87.2 ± 7.1 respectively. The NCS at six months after fixation was 88.7 ± 4.8 in closed reduction cohort and 84.7 ± 9.4 in the open reduction cohort and this difference was not significant (p = 0.1). The NCS at six months after fixation was 85.3 ± 8.3 in 15B1 clavicular fractures and 89.7 ± 4.0 in 15B2 clavicular shaft fractures and this difference was also not significant (p = 0.07). All results pertaining to construct validity were in accordance with our hypothesis thereby suggesting that NCS demonstrates satisfactory construct validity. The ES and SRM were 1.8 and 2.6 respectively. NCS showed no ceiling (0%) or floor effect (0%) at two and six months postoperatively thereby suggesting adequate internal validity of the NCS. CONCLUSION: NCS has satisfactory construct validity, internal validity and responsiveness in surgically treated clavicle shaft fractures with titanium elastic nailing.
Authors: Caroline B Terwee; Sandra D M Bot; Michael R de Boer; Daniëlle A W M van der Windt; Dirk L Knol; Joost Dekker; Lex M Bouter; Henrica C W de Vet Journal: J Clin Epidemiol Date: 2006-08-24 Impact factor: 6.437
Authors: J L Marsh; Theddy F Slongo; Julie Agel; J Scott Broderick; William Creevey; Thomas A DeCoster; Laura Prokuski; Michael S Sirkin; Bruce Ziran; Brad Henley; Laurent Audigé Journal: J Orthop Trauma Date: 2007 Nov-Dec Impact factor: 2.512
Authors: Vinzenz Smekal; Alexander Irenberger; Peter Struve; Markus Wambacher; Dietmar Krappinger; Franz Sebastian Kralinger Journal: J Orthop Trauma Date: 2009-02 Impact factor: 2.512