Marco Monticone

Development of the Italian version of the oswestry disability index (ODI-I): A cross-cultural adaptation, reliability, and validity study

Study Design. Evaluation of the psychometric properties of a translated, culturally adapted questionnaire. Objective. Translating, culturally adapting, and validating the Italian version of the Oswestry Disability Index (ODI-I), allowing its use in Italian-speaking patients with low back pain inside and outside Italy. Summary of Background Data. Growing attention is devoted to standardized outcome measures to improve interventions for low back pain. A translated form of the ODI in patients with low back pain has never been validated within the Italian population. Methods. The ODI-I questionnaire was developed involving forward-backward translation, final review by an expert committee and test of the prefinal version to establish as better as possible proper correspondence with the original English latest version (2.1a). Psychometric testing included factor analysis, reliability by internal consistency (Cronbach α) and test-retest repeatability (Intraclass Coefficient Correlation), concurrent validity by comparing the ODI-I to Visual Analogue Scale, (Pearson correlation), and construct validity by comparing the ODI-I to Roland Morris Disability Questionnaire, RMDQ, and to Short Form Health Survey, Short Form Health Survey-36 (Pearson correlation). Results. The authors required a 3-month period before achieving a shared version of the ODI-I. The questionnaire was administered to 126 subjects, showing satisfying acceptability. Factor analysis demonstrated a 1-factor structure (45% of explained variance). The questionnaire showed high internal consistency (α = 0.855) and good test-retest reliability (ICC = 0.961). Concurrent validity was confirmed by a high correlation with Visual Analogue Scale (r = 0.73, P < 0.001), Construct validity revealed high correlations with RMDQ (r = 0.819, P < 0.001), and with Short Form Health Survey-36 domains, highly significant with the exception of Mental Health (r = −0.139, P = 0.126). Conclusion. The ODI outcome measure was successfully translated into Italian, showing good factorial structure and psychometric properties, replicating the results of existing language versions of the questionnaire. Its use is recommended in research practice.

Effect of a Long-lasting Multidisciplinary Program on Disability and Fear-Avoidance Behaviors in Patients With Chronic Low Back Pain: results of a randomized controlled trial

Objective:To evaluate the effect on disability, kinesiophobia, pain, and the quality of life of a long-lasting multidisciplinary program based on cognitive-behavioral therapy and targeted against fear-avoidance beliefs in patients with chronic low back pain. Methods:Study design: parallel-group, randomized, superiority controlled study. Ninety patients were randomly assigned to a multidisciplinary program consisting of cognitive-behavior therapy and exercise training (experimental group, 45 patients) or exercise training alone (control group, 45 patients). Before treatment (T1), 5 weeks later (instructive phase, T2), and 12 (posttreatment analysis, T3) and 24 months after the end of the instructive phase (1-year follow-up, T4), all of the patients completed a booklet containing the Roland-Morris Disability Questionnaire Scale (primary outcome), the Tampa Scale for Kinesiophobia, a pain numerical rating scale, and the Short-Form Health Survey. A linear mixed model for repeated measures was used to analyze each outcome measure, and the reliable change index/clinically significant change method was used to assess the clinical significance of the changes. Results:The linear mixed model analysis showed a remarkable group, time, and interaction effect for group * time in all of the primary and secondary outcomes (P always <0.001). The majority of the patients in the experimental group achieved a reliable and clinically significant improvement, whereas the majority of those in the control group experienced no change. Conclusions:The long-lasting multidisciplinary program was superior to the exercise program in reducing disability, fear-avoidance beliefs and pain, and enhancing the quality of life of patients with chronic low back pain. The effects were clinically tangible and lasted for at least 1 year after the intervention ended.

Development of the Italian version of the tampa scale of Kinesiophobia (TSK-I): Cross-cultural adaptation, factor analysis, reliability, and validity

Study Design. Evaluation of the psychometric properties of a translated and culturally adapted questionnaire. Objective. Translating, culturally adapting, and validating the Italian version of the Tampa Scale of Kinesiophobia (TSK-I) to allow its use for Italian-speaking patients with low back pain. Summary of Background Data. Increasing attention is being given to standardized outcome measures as a means of improving interventions for low back pain. A translated form of the TSK in patients with low back pain has never been validated in the Italian population. Methods. The development of the TSK-I questionnaire involved its translation and back-translation, a final review by an expert committee, and testing of the prefinal version to establish its correspondence to the original English version. Psychometric testing included factor analysis, reliability by internal consistency (Cronbachs alpha) and test-retest repeatability (Intraclass Coefficient Correlation), discriminant validity (Pearson correlation) by comparing TSK-I to a visual analogue scale, the Roland Morris Disability Questionnaire, Becks Depression Inventory and Anxiety Inventory. Results. It took the authors 5 months to achieve a shared version of the TSK-I, which proved to be satisfactorily acceptable when administered to 178 subjects. Factor analysis indicated a 2-factor 13-item solution (38% of explained variance). The questionnaire showed acceptable internal consistency (&agr; = 0.772) and high test-retest reliability (ICC = 0.956). Discriminant validity showed moderate to low correlations with visual analogue scale (r = 0.345), the Roland Morris Disability (r = 0.337), and Becks Depression Inventory and Anxiety Inventory (r = 0.258 and r = 283). The subscales were also psychometrically analyzed. Conclusion. The TSK was successfully translated into Italian, showing a good factorial structure and psychometric properties, and replicating the results of existing English versions of the questionnaire. Its use is recommended for research purposes.

Development of the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire, SRS-22r-I: cross-cultural adaptation, factor analysis, reliability, and validity.

Study Design. Evaluation of the psychometric properties of a translated and culturally adapted questionnaire. Objective. Translating, culturally adapting, and validating the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire (SRS-22r-I) in order to allow its use with Italian-speaking patients with adolescent idiopathic scoliosis (AIS). Summary of Background Data. Increasing attention is being given to health-related quality of life measures as a means of adding information about the evaluation of AIS. A translated form of the revised SRS-22 has never been validated in Italian patients with AIS. Methods. The development of the SRS-22 questionnaire involved its translation and back-translation, a final review by an Expert Committee, and testing of the prefinal version to establish its correspondence to the original English version. Psychometric testing included factor analysis, reliability by internal consistency (Cronbach alpha) and test-retest repeatability (Intraclass Coefficient Correlation), and concurrent validity (Pearson correlation) by comparing the SRS-22r-I domains with the Short-Form Health Survey (SF-36) subscales. Results. It took 4 months to develop a shared version of the SRS-22r-I, which proved to be satisfactorily acceptable when administered to 223 subjects with AIS. Factor analysis indicated a 4-factor solution (54% of the explained variance), and the questionnaire had an acceptable level of internal consistency (&agr; = 0.77) and a high level of test-retest reliability (intraclass correlation coefficient = 0.957). In terms of concurrent validity, the correlations with the related Short-Form-36 subscales were moderate to good in the case of the Pain and Mental Health domains, and moderate in the case of the Function and Self-Image domains. Conclusion. The Italian translation of the SRS-22r has a good factorial structure and psychometric properties, and replicates the results of existing English versions of the questionnaire. Its use for research purposes can therefore be recommended.

Development of the Italian version of the knee injury and osteoarthritis outcome score for patients with knee injuries: cross-cultural adaptation, dimensionality, reliability, and validity

OBJECTIVE Translating, culturally adapting and validating an Italian version of the Knee injury and Osteoarthritis Outcome Score (KOOS-I) to allow its use with Italian-speaking patients with knee complaints. DESIGN The KOOS-I was developed by means of forward-backward translation, a final review by an expert committee, and a test of the pre-final version to establish its correspondence with the original English version. The psychometric testing included analysis of dimensionality using item-scale correlation after correction for overlap, reliability by means of internal consistency (Cronbachs alpha) and test-retest reliability (Intraclass Correlation Coefficients), and construct validity using an a priori hypothesised Pearson correlations with a Numerical Rating Scale (NRS) and the Short-Form 36 Health Survey (SF-36). RESULTS The questionnaire was administered to 224 subjects with knee injuries and proved to be acceptable. Hypothesised item-to-domain correlations were observed for all of the items. The questionnaire showed good internal consistency (0.782-0.977), and a high level of test-retest reliability (0.850-0.949). Construct validity was supported by the confirmation of the a priori hypothesised correlations. CONCLUSIONS The KOOS outcome measure was successfully translated into Italian, and proved to have good psychometric properties that replicated the results of existing versions. Its use is recommended for clinical and research purposes in patients with knee injuries.

Development of the Italian version of the Neck Pain and Disability Scale, NPDS-I: cross-cultural adaptation, reliability, and validity.

Study Design. Evaluation of the psychometric properties of the Neck Pain and Disability Scale (NPDS). Objective. Translating, culturally adapting, and validating the Italian version of the NPDS-I. Summary of Background Data. Great importance is devoted to validated and comprehensive outcome measures to improve interventions for neck pain. A translated form of a functional scale in patients with neck pain has never been studied within the Italian population. Methods. The Italian version of the NPDS questionnaire was developed involving forward-backward translation and final review by an expert committee to establish multidimensional correspondence with the original English form. Psychometric testing included factor analysis with Varimax rotation, reliability by internal consistency (Cronbachs alpha) and test-retest repeatability (Spearmans rank test), validity by comparing the Italian version of SF-36 to NPDS-I (Pearsons correlation); further subscales comparisons to single SF-36 domains were also conducted. Results. The authors required a 4-month period before achieving a shared version of the NPDS-I. The form was administered to 157 subjects, presenting good acceptability. Factor analyses demonstrated 3 subscales (63% of explained variance), defined as neck dysfunction related to general activities (subscale 1, 8 items), neck pain and cognitive-behavioral aspects (subscale 2, 8 items), neck dysfunction related to activities of the cervical spine (subscale 3, 4 items). The questionnaire showed high internal consistency (NPDS: 0.942, subscale 1: 0.919, subscale 2: 0.856, subscale 3: 0.889) and good test-retest reliability (P < 0.001). Validity was explained by high correlations with SF-36 total score (r = −0.47, P < 0.001) and with single SF-36 domains scores, highly significant (P < 0.001) with the exception of physical role domain (r = −0.17, P = 0.035). Finally, the 3 subscales demonstrated good correlations when compared with selected SF-36 domains. Conclusion. The NPDS-I outcome questionnaire was successfully translated into Italian, showing good multidimensional and psychometric properties, supporting the results of the already existing versions of the scale. Its use is recommended in clinical and research practice.

In-patient multidisciplinary rehabilitation for Parkinson's disease: A randomized controlled trial

This study was undertaken to evaluate the effects of an inpatient 2‐month multidisciplinary rehabilitative program of task‐oriented exercises, cognitive–behavioral training, and occupational therapy on motor impairment, activities of daily living, and quality of life (QoL) in subjects with long‐duration Parkinsons disease (PD).

Chronic neck pain and treatment of cognitive and behavioural factors: Results of a randomised controlled clinical trial

Purpose Although there is growing evidence in favour of the bio-psychosocial approach to the treatment of persistent neck pain, it is questioned whether treating psychological factors can improve patient perceptions of disability, pain and quality of life. This randomised, controlled study with 12 months’ follow-up was conducted to evaluate the efficacy of adding cognitive-behavioural principles to exercises for chronic neck pain.

A Novel Adaptive, Real-Time Algorithm to Detect Gait Events From Wearable Sensors

A real-time, adaptive algorithm based on two inertial and magnetic sensors placed on the shanks was developed for gait-event detection. For each leg, the algorithm detected the Initial Contact (IC), as the minimum of the flexion/extension angle, and the End Contact (EC) and the Mid-Swing (MS), as minimum and maximum of the angular velocity, respectively. The algorithm consisted of calibration, real-time detection, and step-by-step update. Data collected from 22 healthy subjects (21 to 85 years) walking at three self-selected speeds were used to validate the algorithm against the GaitRite system. Comparable levels of accuracy and significantly lower detection delays were achieved with respect to other published methods. The algorithm robustness was tested on ten healthy subjects performing sudden speed changes and on ten stroke subjects (43 to 89 years). For healthy subjects, F1-scores of 1 and mean detection delays lower than 14 ms were obtained. For stroke subjects, F1-scores of 0.998 and 0.944 were obtained for IC and EC, respectively, with mean detection delays always below 31 ms. The algorithm accurately detected gait events in real time from a heterogeneous dataset of gait patterns and paves the way for the design of closed-loop controllers for customized gait trainings and/or assistive devices.

Responsiveness and minimal important changes for the knee injury and osteoarthritis outcome score in subjects undergoing rehabilitation after total knee arthroplasty

ObjectiveThe aim of this study was to evaluate the responsiveness and minimal important changes for the Knee Injury and Osteoarthritis Outcome Score (KOOS) in subjects undergoing rehabilitation after total knee arthroplasty. DesignAt the beginning and end of a rehabilitation program, 148 patients completed the KOOS. A global perception of change scale was also completed at the end of the program and collapsed to produce a dichotomous outcome (improved vs. stable). Responsiveness was assessed on the KOOS subscales and calculated by distribution methods (effect size; standardized response mean). The minimal important changes of the KOOS subscales were assessed using anchor-based methods (receiver operating characteristic curves) to compute the best cutoff levels between the improved and stable subjects. ResultsThe effect sizes ranged from 0.83 to 1.35, and the standardized response means ranged from 0.76 to 1.22. The receiver operating characteristic analyses revealed an area under the curve of 0.89, 0.88, 0.94, 0.93, and 0.85 for the Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and Quality of Life subscales, respectively, showing discriminative capacities; the minimal important changes were 16.7 for Pain (sensitivity: 83%; specificity: 82%), 10.7 for Symptoms (80%; 80%), 18.4 for Activities of Daily Living (82%; 82%), 12.5 for Sport/Recreation (96%; 78%), and 15.6 for Quality of Life (88%; 67%). ConclusionsThe KOOS was sensitive in detecting clinical changes. The authors recommend taking the minimal important changes provided into account when assessing patient improvement or planning studies in this clinical context.