A novel multistep approach to standardize the reported risk factors for in-hospital falls: a proof-of-concept study.

Background: Uncertainty and inconsistency in terminology regarding the risk factors (RFs) for in-hospital falls are present in the literature. Objective: (1) To perform a literature review to identify the fall RFs among hospitalized adults; (2) to link the found RFs to the corresponding categories of international health classifications to reduce the heterogeneity of their definitions; (3) to perform a meta-analysis on the risk categories to identify the significant RFs; (4) to refine the final list of significant categories to avoid redundancies. Methods: Four databases were investigated. We included observational studies assessing patients who had experienced in-hospital falls. Two independent reviewers performed the inclusion and extrapolation process and evaluated the methodological quality of the included studies. RFs were grouped into categories according to three health classifications (ICF, ICD-10, and ATC). Meta-analyses were performed to obtain an overall pooled odds ratio for each RF. Finally, protective RFs or redundant RFs across different classifications were excluded. Results: Thirty-six articles were included in the meta-analysis. One thousand one hundred and eleven RFs were identified; 616 were linked to ICF classification, 450 to ICD-10, and 260 to ATC. The meta-analyses and subsequent refinement of the categories yielded 53 significant RFs. Overall, the initial number of RFs was reduced by about 21 times. Conclusion: We identified 53 significant RF categories for in-hospital falls. These results provide proof of concept of the feasibility and validity of the proposed methodology. The list of significant RFs can be used as a template to build more accurate measurement instruments to predict in-hospital falls.

Cross-cultural adaptation and psychometric properties of the Italian version of the Patient-Specific Functional Scale (PSFS) in subjects with shoulder pain.

PURPOSE: To cross-culturally adapt the Patient-Specific Functional Scale (PSFS) into Italian and study its classic psychometric properties in subjects with shoulder pain (SP). MATERIALS AND METHODS: The PSFS was translated into Italian and administered to 109 SP subjects. Acceptability (time to administer, floor and ceiling effects), reliability (internal consistency [Cronbach's alpha], test-retest reliability [Intraclass Correlation Coefficient (ICC)], and measurement error [Standard Error of Measurement (SEM), Minimal Detectable Change, (MDC)]), were assessed. Moreover, construct validity was investigated through a-priori hypothesis testing, comparing the PSFS with the Disability of the Shoulder, Arm and Hand (DASH) scale, 36-item Short Form Health Survey (SF-36) and Numeric Pain Rating scale (NPRS). RESULTS: The PSFS was successfully adapted into Italian, and its acceptability was satisfied. Internal consistency was high (Cronbach's alpha = 0.925), and test-retest reliability was good (ICC = 0.866, 95% CI = 0.749-0.931). A SEM of 0.7 points and an MDC of 1.9 points were obtained. We observed moderate evidence for construct validity, with 4/6 correlations between other measures being respected. CONCLUSION: This study provided reliability and validity of the PSFS in a sample of Italian SP subjects. Future studies should assess the responsiveness of using the PSFS as an outcome measure to capture clinical changes after treatment.

The Patient-Specific Functional Scale is a reliable, and easy-to-use patient-reported outcome measure.The Patient-Specific Functional Scale was cross-cultural validated in the Italian language.The Patient-Specific Functional Scale has excellent internal consistency, high reliability, low measurement error, and moderate construct validity in subjects with shoulder pain.The Patient-Specific Functional Scale can be used in clinical practice by Italian physiotherapists to assess subjects with shoulder pain.

Psychometric properties of the Disability of Arm Shoulder and Hand (DASH) in subjects with frozen shoulder: a reliability and validity study.

BACKGROUND: Frozen Shoulder (FS) is a painful condition characterized by severe pain and progressive restriction of shoulder movement, leading to functional impairment and reduced quality of life. While different Patient Reported Outcome Measurements (PROMs) tools exist for assessing shoulder diseases, few specific PROMs are validated for FS patients. PURPOSE: This study aims to assess the psychometric properties of the Disability of Arm, Shoulder, and Hand (DASH) questionnaire in FS patients. METHODS: One hundred and twenty-four subjects (mean ± SD age = 55.4 ± 7.9 years; 55.6% female) diagnosed with FS were included and completed the DASH questionnaire, the Numerical Pain Rating Scale (NPRS), the Shoulder Pain and Disability Index (SPADI), and the Short-Form Health Survey 36 (SF-36). Floor or ceiling effects were investigated. Structural validity was analysed through a unidimensional Confirmatory Factor Analysis (CFA), internal consistency through Cronbach's alpha, test-retest reliability through the Intraclass Correlation coefficient (ICC), measurement error through the Standard Error of Measurement (SEM), and the Minimum Detectable Change (MDC), and construct validity through the hypothesis testing with the correlation with the other outcome measures used. RESULTS: No floor or ceiling effects were observed. CFA confirmed a one-factor structure after addressing local item dependency (Root Mean Square Error of Approximation = 0.055; Standardized Root Mean Square Residual = 0.077; Comparative Fit Index = 0.970; Tucker-Lewis Index = 0.968). Cronbach's alpha was high (= 0.951), and test-retest reliability was excellent (ICC = 0.999; 95% CI: 0.998-1.000). SEM was equal to 0.5 points, and MDC to 1.5 points. Construct validity was considered satisfactory as 80% of the a-priori hypotheses were met. CONCLUSION: The DASH questionnaire demonstrated good psychometric properties in FS patients, supporting its use as a valuable tool for assessing the impact of FS in clinical and research settings.

Rasch analysis of the forgotten joint score in patients with total hip arthroplasty.

OBJECTIVE: To assess the internal construct validity, including local independence, unidimensionality, monotonicity, and invariance, reliability, and targeting of the Forgotten Joint Score within the Rasch Measurement Theory framework. DESIGN: Cross-sectional study. PATIENTS: A total of 111 patients with total hip arthroplasty at least 3 months after surgery. METHODS: The Forgotten Joint Score was submitted to each subject during their rehabilitative treatment in an Italian centre and then to Rasch analysis. RESULTS: The base Rasch analysis showed a satisfactory fit to the model with strict unidimensionality and no differential item functioning. However, monotonicity (11 out of 12 items showed disordered thresholds) and local independence were  violated. After rescoring 10 items and creating 5 subtests to account for local dependence, the scale satisfied all the other Rasch model requirements (i.e. invariance, local independence, monotonicity, unidimensionality, and multi-group invariance), with reliability indexes (> 0.850) for measurement at the individual level and proper targeting. A raw-score-to-measure conversion table was provided. CONCLUSION: After structural (i.e. collapsing items categories) and non-structural (i.e. creating subtests) strategies, the Forgotten Joint Score satisfied the measurement requirements of the Rasch model, and it can be used in patients with total hip arthroplasty in clinical and research settings.

When 'good' is not good enough: a retrospective Rasch analysis study of the Berg Balance Scale for persons with Multiple Sclerosis.

Background: The Berg Balance Scale (BBS) is one of the most used tools to quantify balance in Persons with Multiple Sclerosis, a population at high risk of falling. Aim: To evaluate the measurement characteristics of the BBS in Multiple Sclerosis through Rasch analysis. Design: Retrospective study. Setting: Outpatients in three Italian Rehabilitation centers. Population: Eight hundred and fourteen persons with Multiple Sclerosis able to stand independently for more than 3 s. Methods: The sample (N = 1,220) was split into one validating (B1) and three confirmatory subsamples. Following the Rasch analysis performed on B1, the item estimates were exported and anchored to the three confirmatory subsamples. After obtaining the same final solution across all samples, we studied the convergent and discriminant validity of the final BBS-MS using the EDSS, the ABC scale, and the number of falls. Results: The base analysis on the B1 subsample failed the monotonicity, local independence, and unidimensionality requirements and did not fit the Rasch model. After grouping locally dependent items, the BBS-MS fitted the model (χ28 = 23.8; p = 0.003) and satisfied all requirements for adequate internal construct validity (ICV). However, it was mistargeted to the sample, given the striking prevalence of higher scores (targeting index 1.922) with a distribution-independent Person Separation Index sufficient for individual measurements (0.962). The B1 item estimates were anchored to the confirmatory samples with confirmation of adequate fit (χ2 = [19.0, 22.8], value of ps = [0.015, 0.004]) and satisfaction of all ICV requirements for all subsamples. The final BBS-MS directly correlated with the ABC scale (rho = 0.523) and inversely with EDSS (rho = -0.573). The BBS-MS estimates significantly differed across groups according to the pre-specified hypotheses (between the three EDSS groups, between the ABC cut-offs, distinguishing 'fallers' vs. 'non-fallers', and between the 'low' vs. 'moderate' vs. 'high' levels of physical functioning; and, finally, between 'no falls' vs. 'one or more falls'). Conclusion: This study supports the internal construct validity and reliability of the BBS-MS in an Italian multicentre sample of persons with Multiple Sclerosis. However, as the scale is slightly mistargeted to the sample, it represents a candidate tool to assess balance, mainly in more disabled people with an advanced walking disability.

The Early Functional Abilities-revised may bridge the gap between the disorder of consciousness and the functional independence scales: evidence from Rasch analysis.

BACKGROUND: There is a tremendous clinical and research need to bridge the gap between disorder of consciousness and functional independence scales with a single unidimensional measure in people with acquired brain injury. AIM: To calibrate an essentially unidimensional subset of items from the Italian Early Functional Abilities (EFA), demonstrating internal construct validity and sufficient reliability for individual patient measurement. DESIGN: Multicenter observational cross-sectional study. SETTING: Inpatients from 11 different Italian Rehabilitation centers. POPULATION: Three hundred sixty-two adult patients with a disorder of consciousness due to an acquired brain injury. METHODS: The Italian version of EFA was administered to the sample and then submitted to Mokken analysis, Confirmatory Factor Analysis, Rasch analysis, Confirmatory Bifactor Analysis, and external construct validity. RESULTS: According to Mokken Analysis (all item scalability coefficients Hj positive; all item-pair scalability coefficients Hij >0.3; scale coefficient H=0.762), and Confirmatory Factor Analysis (RMSEA=0.081; SRMR=0.048; CFI=0.995; TLI=0.995), the Italian EFA showed a sufficient preliminary unidimensionality. Within Rasch Analysis, a final 12-item solution for the EFA (EFA-R) was calibrated. EFA-R is "essentially unidimensional" according to the following requirements: 1) analysis of residual correlations which supported item essential local independence; 2) a robust correlation between item subtests (rho=0.950); 3) only 2.1% of cases with significant difference between person parameter estimates by different subscales; 4) an explained common variance equal to 0.916 obtained from a final Confirmatory Bifactor Analysis. It also satisfied invariance requirement (unconditional χ220=9.81; P=0.457, conditional class-interval based χ235=33.1; P=0.557), and monotonicity. The reliability (Person Separation Index=0.887) was adequate for person measurements. A practical raw-score-to-measure conversion table based on the EFA-R calibration was devised. Finally, EFA-R strongly correlated with Coma Recovery Scale-Revised (rho=0.922) and motor FIM™ (rho=0.808). CONCLUSIONS: EFA-R is an essentially unidimensional subset of 12 items with adequate internal construct validity and sufficient reliability for individual patient measurement under the Rasch Model Theory framework. CLINICAL REHABILITATION IMPACT: EFA-R has the potential to measure people's functional abilities whose consciousness is improving despite ongoing severe motor-functional impairments during the early stages of rehabilitation. It provides "a measurement bridge" between the disorder of consciousness and the functional independence scales in patients with severe acquired brain injury.

Efficacy of a multiple-component and multifactorial personalized fall prevention program in a mixed population of community-dwelling older adults with stroke, Parkinson's Disease, or frailty compared to usual care: The PRE.C.I.S.A. randomized controlled trial.

Background: Fall risk in the elderly is a major public health issue due to the injury-related consequences and the risk of associated long-term disability. However, delivering preventive interventions in usual clinical practice still represents a challenge. Aim: To evaluate the efficacy of a multiple-component combined with a multifactorial personalized intervention in reducing fall rates in a mixed population of community-dwelling elderly compared to usual care. Design: Randomized Controlled Trial (NCT03592420, clinicalTrials.gov). Setting: Outpatients in two Italian centers. Population: 403 community-dwelling elderly at moderate-to-high fall risk, including subjects with Parkinson's Disease and stroke. Methods: After the randomization, the described interventions were administered to the intervention group (n = 203). The control group (n = 200) received usual care and recommendations to minimize fall risk factors. In addition, each participant received a fall diary, followed by 12 monthly phone calls. The primary endpoint was the total number of falls in each group over 12 months, while the secondary endpoints were other fall-related indicators recorded at one year. In addition, participants' functioning was assessed at baseline (T1) and 3-month (T3). Results: 690 falls were reported at 12 months, 48.8% in the intervention and 51.2% in the control group, with 1.66 (± 3.5) and 1.77 (± 3.2) mean falls per subject, respectively. Subjects with ≥ 1 fall and ≥2 falls were, respectively, 236 (58.6%) and 148 (36.7%). No statistically significant differences were observed between groups regarding the number of falls, the falling probability, and the time to the first fall. According to the subgroup analysis, no significant differences were reported. However, a statistically significant difference was found for the Mini-BESTest (p = 0.004) and the Fullerton Advanced Balance Scale (p = 0.006) for the intervention group, with a small effect size (Cohen's d 0.26 and 0.32, respectively), at T1 and T3 evaluations. Conclusions: The intervention was ineffective in reducing the number of falls, the falling probability, and the time to the first fall at 12 months in a mixed population of community-dwelling elderly. A significant improvement for two balance indicators was recorded in the intervention group. Future studies are needed to explore different effects of the proposed interventions to reduce falls and consequences.

'Less is more': validation with Rasch analysis of five short-forms for the Brain Injury Rehabilitation Trust Personality Questionnaires (BIRT-PQs).

BACKGROUND: Previous analyses demonstrated a lack of unidimensionality, item redundancy, and substantial administrative burden for the Brain Injury Rehabilitation Trust Personality Questionnaires (BIRT-PQs). OBJECTIVE: To use Rasch Analysis to calibrate five short-forms of the BIRT-PQs, satisfying the Rasch model requirements. METHODS: BIRT-PQs data from 154 patients with severe Acquired Brain Injury (s-ABI) and their caregivers (total sample = 308) underwent Rasch analysis to examine their internal construct validity and reliability according to the Rasch model. RESULTS: The base Rasch analyses did not show sufficient internal construct validity according to the Rasch model for all five BIRT-PQs. After rescoring 18 items, and deleting 75 of 150 items, adequate internal construct validity was achieved for all five BIRT-PQs short forms (model chi-square p-values ranging from 0.0053 to 0.6675), with reliability values compatible with individual measurements. CONCLUSIONS: After extensive modifications, including a 48% reduction of the item load, we obtained five short forms of the BIRT-PQs satisfying the strict measurement requirements of the Rasch model. The ordinal-to-interval measurement conversion tables allow measuring on the same metric the perception of the neurobehavioral disability for both patients with s-ABI and their caregivers.

The unidimensionality of the five Brain Injury Rehabilitation Trust Personality Questionnaires (BIRT-PQs) may be improved: preliminary evidence from classical psychometrics.

Objective: To assess the internal construct validity (ICV) of the five Brain Injury Rehabilitation Trust Personality Questionnaires (BIRT-PQ) with Classical Test Theory methods.Methods: Multicenter cross-sectional study involving 11 Italian rehabilitation centers. BIRT-PQs were administered to patients with severe Acquired Brain Injury and their respective caregivers. ICV was assessed by the mean of an internal consistency analysis (ICA) and a Confirmatory Factor Analysis (CFA).Results: Data from 154 patients and their respective caregivers were pooled, giving a total sample of 308 subjects. Despite good overall values (alphas ranging from 0.811 to 0.937), the ICA revealed that several items within each scale did not contribute as expected to the total score. This result was confirmed by the CFA, which showed the misfit of the data to a unidimensional model (RMSEA ranging from 0.077 to 0.097). However, after accounting for local dependency found within the data, fitness to a unidimensional model improved significantly (RMSEA ranging from 0.050 to 0.062).Conclusion: Despite some limitations, our analyses demonstrated the lack of ICV for the BIRT-PQ total scores. It is envisaged that a more comprehensive ICV analysis will be performed with Rasch analysis, aiming to improve both the measurement properties and the administrative burden of each BIRT-PQ.

A Rasch analysis of the Conley Scale in patients admitted to a general hospital.

Purpose: The Conley Scale (CS) is a widely used tool for assessing the risk of falling for inpatients. The purpose of this study was to assess its unidimensionality, internal construct validity, targeting and reliability using Confirmatory Factor Analysis (CFA) and Rasch analysis (RA).Methods: The CS was administrated to a sample of 58,370 subjects admitted to a general hospital.Results: The CFA supported the unidimensionality of the CS (Root Mean Square Error of Approximation (RMSEA) = 0.040) only after adjusting for local dependency between two items. The scale did not fit the Rasch model (χ218 = 4688.5; p = 0.0000) and this was confirmed notwithstanding adjusting for type-I error (by creating 10-subsample of 250 subjects) and extensive post-hoc modifications. The analysis of targeting showed a marked floor effect (47.1%), whereas the reliability appeared adequate for group measurement (0.800) only after adjusting for the skewed distribution of the calibrating sample.Conclusion: The results of this study suggested that the CS, although unidimensional, could not provide interval-scale measurement of the risk of falling, had a measurement range that mismatched the ability range of the population being measured, and had a reliability inadequate for individual person measurements. Given these findings, the use of the CS to identify inpatients at risk of falling is not recommended.Implications for rehabilitationThe Conley Scale is a unidimensional tool according to Confirmatory Factor Analysis.However, Rasch analysis demonstrated that the tool could not provide interval-scale measurement of the risk of falling, had a measurement range that did not fit the ability range of the population being measured, and had a level of reliability which was inadequate for its intended purpose, that is individual person measurement.The diagnostic utility of the known published cutoff is severely hampered by the severe mistargeting and reduced reliability of the tool.Given these shortcomings, the Conley Scale cannot be recommended to identify inpatients at risk of falling.

Can we scientifically and reliably measure the level of consciousness in vegetative and minimally conscious States? Rasch analysis of the coma recovery scale-revised.

OBJECTIVES: (1) To appraise, by the means of Rasch analysis, the internal validity and reliability of the Coma Recovery Scale-Revised (CRS-R) in a sample of patients with disorder of consciousness (DOC); and (2) to provide information about the comparability of CRS-R scores across persons with DOC across different settings and groups, including different etiologies. DESIGN: Multicenter observational prospective study. SETTING: Two rehabilitation wards, 1 intermediate care facility, and 2 nursing homes in Italy. PARTICIPANTS: Consecutively admitted patients (N=129) for which assessments at 2 different time points were available, giving a total sample of 258 observations. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: CRS-R. RESULTS: After controlling for any possible dependency between persons' measures collected at different time points, and for uniform differential item functioning by etiology showed by the visual subscale, Rasch analysis demonstrated adequate satisfaction of all the model's requirements, including adequate ordering of scoring categories, unidimensionality, local independence, invariance (χ(2)21=27.798, P=.146), and absence of differential item functioning across patients' sex, age, time, and setting. The reliability (person separation index=.896) was adequate for individual person measurement. We devised a practical raw score to measure conversion tables based on the CRS-R calibrations. CONCLUSIONS: The CRS-R is a psychometrically sound and robust measurement tool. The linear measures of ability derived from the CRS-R total scores do satisfy all the principles of scientific measurement and are sufficiently reliable for high stakes assessments, such as the diagnosis of the level of consciousness in individual patients. Future studies are needed to directly explore the capabilities of the CRS-R measures to reduce the risk of vegetative state misdiagnosis.

Is the Berg Balance Scale an internally valid and reliable measure of balance across different etiologies in neurorehabilitation? A revisited Rasch analysis study.

OBJECTIVES: To assess, within the context of Rasch analysis, (1) the internal validity and reliability of the Berg Balance Scale (BBS) in a sample of rehabilitation patients with varied balance abilities; and (2) the comparability of the BBS measures across different neurologic diseases. DESIGN: Observational prospective study. SETTING: Rehabilitation ward of an Italian district hospital. PARTICIPANTS: Consecutively admitted inpatients and outpatients (N=217); for 85 participants, data were collected both on admission and discharge, giving a total sample of 302 observations. INTERVENTION: Not applicable. MAIN OUTCOME MEASURE: BBS. RESULTS: Most of the BBS items had to be rescored, and 2 items (static sitting and standing balance) had to be deleted, to attain adequate internal construct validity (χ(2)(24)=35.68; P=.059). The reliability of the Rasch-modified BBS (BBS-12) (total score, 0-35) was high (.957), indicating precision of measurement at the individual level. The analysis of differential item functioning (DIF) showed invariance of the item calibrations across patients' sex, age, and etiology. After adjusting for the possible effect of repeated measurements on person estimates, the analysis of DIF by timing of assessment confirmed the stability of the item hierarchy across time. A practical ruler was provided to convert item raw scores into Rasch estimates of balance ability. CONCLUSIONS: This study supports the internal validity and reliability of the BBS-12 as a measurement tool independent of the etiology of the neurologic disease causing the balance impairment. In view of some sample-related issues and that not all possible etiologies encountered in the neurorehabilitation settings were tested, a larger multicenter study is warranted to confirm these findings.

Unified Balance Scale: an activity-based, bed to community, and aetiology-independent measure of balance calibrated with Rasch analysis.

OBJECTIVE: To build a new activity-based, "bed to community", aetiology-independent measure of balance within the neurological rehabilitation setting by merging some existing scales. METHODS: Balance scales were selected using a conceptual framework and subsequently administered to a convenience sample of adult patients with balance problems due to different neurological aetiologies. Data were then processed using classical psychometric analyses and Rasch analysis in order to construct a new balance measurement tool. RESULTS: The Berg Balance Scale, the Tinetti Scales and the Fullerton Advanced Balance Scale were selected and administered to a sample of patients, giving 302 observations. Classical psychometric analyses (item and scale analysis; confirmatory factor analysis) were undertaken on the pooled 40-item set with confirmation of unidimensionality. The subsequent Rasch analysis allowed the identification of a 27-item set satisfying the Rasch Model's requirements for fundamental measurement, with further confirmation of unidimensionality by post-hoc confirmatory factor analysis. CONCLUSION: The new scale (Unified Balance Scale) holds proven measurement properties and may be a candidate tool for "bed to community" balance measurement for patients with balance problems within the neuro-rehabilitation setting. Future studies are warranted to explore further its external validity and other clinical properties, as well as to improve its usability.

Unified Balance Scale: classic psychometric and clinical properties.

OBJECTIVE: To evaluate the classic psychometric and clinical profile of the Unified Balance Scale, a novel Rasch-based measure of balance. METHODS: The Unified Balance Scale was administered to 219 neurological patients (providing 302 observations) admitted to rehabilitation, together with: Timed Up & Go, 10-meters walking test, Functional Ambulation Classification (FAC), Walking Handicap Scale, FIM™, Trunk Control Test, Motricity Index, and posturographic indexes. Analyses included: concurrent validity, external construct validity (convergent, divergent and discriminant validity), responsiveness, interpretability, predictive validity and usability. RESULTS: External construct validity (e.g. correlation with FAC: rho=0.80; with the motor FIM™: rho=0.55), adequate responsiveness (effect size 1.13), interpretability (the relationship of Unified Balance Scale scores with those of the originating scales and, indirectly, with the risk of falling), and, finally, predictive validity (e.g. relative risk of nursing home admission: 4.33 (95% confidence interval 2.43-7.73) for Unified Balance Scale scores ≤ 2 on admission) were demonstrated for the Unified Balance Scale. Analysis of usability suggested a mean administration time of 20-30 min. CONCLUSION: Although further studies are needed to generalize these results to different samples, to confirm its fall risk estimation capabilities and to improve its usability, the Unified Balance Scale presents itself as a psychometrically sound outcome measurement tool to evaluate the effectiveness both of fall reduction plans and of rehabilitation interventions aimed at improving balance.