Lower Quadrant Edema Patient-Reported Outcome Measure Is Reliable, Valid, and Efficient for Patients With Lymphatic and Venous Disorders.

OBJECTIVE: The main aims of this study were: (1) to create a patient-reported outcome measure (PROM) item bank for measuring the impact of lower quadrant edema (LQE) on physical function using item response theory and (2) to assess reliability, validity, and administration efficiency of LQE PROM scores based on computerized adaptive test (CAT) and the reliability of a 10-item short form (SF). METHODS: This retrospective study included data from patients treated in outpatient rehabilitation clinics for lower quadrant edema who responded to all 30 candidate items at intake. Item response theory model assumptions of unidimensionality, local item independence, item fit, and presence of differential item functioning (DIF) were evaluated. LQE-CAT-generated scores were assessed for reliability, validity, and administration efficiency. LQE-SF-generated scores were assessed for reliability. RESULTS: The total cohort included 4894 patients (mean [SD] age = 65 [14] years; range = 14-89 years). A set of 20 items was selected for the item bank based on support for its unidimensionality and fit to the item response theory model, with reliability estimates greater than 0.92 for CAT and SF administration modes. No items demonstrated DIF with respect to tested variables. After controlling for scores at intake, scores discriminated among multiple patient groups in clinically logical ways with better outcomes observed for patients who were younger with less chronic symptoms and fewer comorbidities. Scores were responsive to change but the effect size was small (0.4). There were negligible floor and ceiling effects. CAT administration of the item bank required an average of 6.1 items (median = 5). Scores correlated highly with full-bank scores (Pearson correlation coefficient = 0.98). CONCLUSION: Scores on the LQE PROM were reliable, valid, and efficient for assessing perceived physical function of patients with lower quadrant edema. The LQE, CAT, and SF are suitable for research and routine clinical care. Reasons for the small effect size for change scores should be studied. IMPACT: The newly developed LQE PROM was reliable and valid and offered efficient administration modes for assessing perceived physical function of patients with LQE, both for research and routine clinical care in busy outpatient rehabilitation settings. As an item response theory-based measure, the LQE PROM allows administration of condition-specific functional questions with low response burden for patients. The 10-item LQE-SF offers a feasible alternative administration mode when CAT administration is not available. This study supports a transition to PROMs that are based on modern measurement approaches to achieve the combined benefits of high accuracy and efficiency.

The Stroke Upper and Lower Extremity Physical Function Measures Were Supported for Score Reliability, Validity, and Administration Efficiency for Patients Poststroke.

OBJECTIVE: The aims of this study were to (1) evaluate the suitability of newly developed items for calibration into 2 item banks for stroke upper extremity (SUE) and stroke lower extremity (SLE) physical function (PF) patient-reported outcome measures (PROMs) and to (2) assess score reliability and validity and PROM administration efficiency based on computerized adaptive testing (CAT). METHODS: A retrospective longitudinal study involving patients poststroke who were treated in outpatient rehabilitation clinics and responded to 28 and 25 region-specific candidate items addressing tasks related to upper or lower extremity PF, respectively, was conducted. Item response theory (IRT) model assumptions of unidimensionality, local independence, item fit, and presence of differential item functioning were evaluated. CAT-generated scores were assessed for reliability, validity, and administration efficiency, and 10-item short forms were assessed for reliability. RESULTS: Cohorts consisted of 2017 patients with stroke involving the upper extremity and 2107 patients with stroke involving the lower extremity (mean age [SD]: SUE = 62 [14] and SLE = 63 [14]; range = 14-89). Two solutions (SUE: 28-item; SLE: 24-item) supported unidimensionality and fit to the IRT model, with reliability estimates >0.93 for all administration modes. No items demonstrated differential item functioning. Scores discriminated among multiple patient groups in clinically logical ways, with better outcomes observed for patients who were younger, were male, had less chronicity, and had fewer comorbidities. The SUE and SLE, respectively, had 1 and 0.3% floor effects and 4.3 and 1.1% ceiling effects. Change score effect sizes were 0.5 (SUE) and 0.6 (SLE). Simulated CAT scores required an average of 6 (SUE) and 5.6 (SLE) items (median = 5). CONCLUSION: The stroke upper extremity and stroke lower extremity PROM scores were reliable, valid, and efficient and had moderate change effect sizes for assessing PF as perceived by patients poststroke with upper and lower extremity impairments. Scores had negligible floor and acceptable ceiling effects. Based on these results, the stroke PROMs are suitable for research and routine clinical practice. IMPACT: As IRT-based measures, these PROMs support clinical practice guideline recommendations for the use of outcome measures in neurologic physical therapy and the administration of condition-specific functional questions with low response burden for patients. The 10-item short forms offer a feasible alternative administration mode when CAT administration is not available.

Reliability, Validity, and Efficiency of an Item Response Theory-Based Balance Confidence Patient-Reported Outcome Measure.

OBJECTIVE: The aims of this study were to calibrate the original 16 items from the Activities-Specific Balance Confidence (ABC) Scale to create an item response theory (IRT)-based item bank and scoring metric of balance confidence (BC) and to assess psychometric properties of a computerized adaptive test (BC-CAT) and 6-item short-form (BC-SF) administration modes. METHODS: This retrospective study included data from patients who were treated in outpatient rehabilitation clinics and assessed for balance impairments by responding to the full ABC Scale at intake. IRT model assumptions of unidimensionality, local item independence, item fit, and presence of differential item functioning (DIF) were evaluated. BC-CAT-generated scores were assessed for reliability, validity, and administration efficiency, and the newly developed BC-SF was assessed for reliability. RESULTS: Total cohort included 20,354 patients (mean age [SD] = 66 [16] years; range = 14-89). All 16 items were retained in the final item bank based on support for unidimensionality and fit to the IRT model. No items demonstrated DIF. Reliability estimates were 0.95, 0.96, and 0.98 for the BC-SF, BC-CAT, and the full item bank, respectively. Scores discriminated among patient groups in clinically logical ways. After controlling for scores at intake, better outcomes were achieved for patients who were younger, had more acute symptoms, exercised more, and had fewer comorbidities. Scores were responsive to change with a moderate effect size, with negligible floor and ceiling effects. CAT scores were generated using an average of 4.7 items (median = 4) and correlated highly with full-bank scores (Pearson correlation coefficient = 0.99). CONCLUSION: The IRT-based BC patient-reported outcome measure (PROM) was reliable, valid, moderately responsive to change, and efficient, with excellent score coverage. The measure is suitable for research and routine clinical administration using the BC-CAT or BC-SF administration modes. The full ABC Scale can be administered for increased clinical content when appropriate. IMPACT: The newly developed BC-PROM was reliable and valid for assessing perceived BC. In addition, the BC-PROM has efficient administration modes with low patient response burden, which enhances feasibility and promotes use during routine clinical practice in busy rehabilitation settings. This study supports a transition to PROMs that are based on modern measurement approaches to achieve the combined benefits of high accuracy and efficiency.

Is Telerehabilitation a Viable Option for People With Low Back Pain? Associations Between Telerehabilitation and Outcomes During the COVID-19 Pandemic.

OBJECTIVE: The aims of this study were to examine associations between frequency of telerehabilitation (TR) and outcomes of functional status (FS), number of visits, and patient satisfaction during COVID-19 and to compare FS outcomes by TR delivery mode for individuals with low back pain. METHODS: Propensity score matching was used to match episodes of care with or without TR exposure by the probability of receiving TR. FS, visits, and satisfaction were compared for individuals without TR and those who received care by TR for "any," "few," "most," or "all" frequencies (4 matched samples), and FS was compared for individuals receiving synchronous, asynchronous, and mixed TR modes (3 matched samples). Standardized differences were used to compare samples before and after matching. Outcomes between matched samples were compared using z tests with 95% CI. RESULTS: The sample consisted of 91,117 episodes of care from 1398 clinics located in 46 states (58% women; mean age = 55 [SD = 18]). Of those, only 5013 episodes (5.5%) involved any amount of TR. All standardized differences between matched samples were <0.1. There was no significant difference in FS points (range = 0-100, with higher representing better FS) between matched samples, except for episodes that had ``few'' (-1.7) and ``all'' (+2.0) TR frequencies or that involved the asynchronous (-2.6) TR mode. These point differences suggest limited clinical importance. Episodes with any TR frequency involved significantly fewer visits (0.7-1.3) than episodes with no TR, except that those with the "most" TR frequency had non-significantly fewer visits (0.6). A smaller proportion of individuals with TR (-4.0% to -5.0%) than of individuals with no telerehabilitation reported being very satisfied with treatment results, except for those with the "all" TR frequency. CONCLUSIONS: A positive association between TR and rehabilitation outcomes was observed, with a trend for better FS outcomes and fewer visits when all care was delivered through TR. Satisfaction tended to be lower with TR use. Overall, this observational study showed that for people with low back pain, physical therapy delivered through TR was equally effective as and more efficient than in-person care, with a trend of higher effectiveness when used for all visits during the episode of care. No differences in FS outcomes were observed between care delivered with synchronous and mixed TR delivery modes and care delivered with no TR. However, the asynchronous mode of TR was associated with worse functional outcomes than no TR. Although the majority of people were very satisfied with their treatment results with and without TR, very high satisfaction rates were reported by a slightly smaller proportion of individuals with TR versus those without TR. Our results suggest that TR is a viable option for rehabilitation care for individuals with low back pain and should also be considered in the post-COVID-19 era.

Upper Quadrant Edema Patient-Reported Outcome Measure Is Reliable, Valid, and Efficient for Patients With Lymphatic and Venous Disorders.

OBJECTIVE: The main aims of this study were to (1) create a patient-reported outcome measure (PROM) item bank for measuring the impact of upper quadrant edema (UQE) on physical function by calibrating responses to newly developed items; and (2) assess reliability, validity, and administration efficiency of scores based on computerized adaptive test (CAT) and 10-item short-form (SF) administration modes. METHODS: This was a retrospective study including data from patients treated in outpatient rehabilitation clinics for UQE that responded to all 27 candidate items at intake. Item response theory model assumptions of unidimensionality, local item independence, item fit, and presence of differential item functioning were evaluated. UQE-CAT- and UQE-SF-generated scores were assessed for reliability, validity, and administration efficiency. RESULTS: The total cohort included 3486 patients (mean [SD] age = 61 [13] years; range = 14-89 years). After removing 2 items, a 25-item solution was supported for its unidimensionality and fit to the item response theory model with reliability estimates of more than 0.93 for scores based on both CAT and SF administration modes. No items demonstrated differential item functioning. Scores discriminated among multiple patient groups in clinically logical ways and were moderately responsive to change with negligible floor and acceptable ceiling effects. CAT scores were generated using an average of 5.6 items (median = 5). CONCLUSION: Scores on the UQE PROM were reliable, valid, and efficient for assessing perceived physical function of patients with upper quadrant edema; thus, the measure is suitable for research and routine clinical administration. IMPACT: The newly developed UQE PROM is reliable and valid and offers efficient administration modes for assessing perceived physical function of patients with UQE caused by lymphatic and venous disorders, both for research and routine clinical care in busy outpatient rehabilitation settings. As an item response theory-based measure, the UQE PROM allows administration of condition-specific functional questions with low response burden for patients. This study supports a transition to PROMs that are based on modern measurement approaches to achieve high accuracy and efficiency.

Telerehabilitation During the COVID-19 Pandemic in Outpatient Rehabilitation Settings: A Descriptive Study.

OBJECTIVE: COVID-19 has widely affected delivery of health care. In response, telerehabilitation (TR) has emerged as alternative care model. Aims were: (1) to describe baseline patient characteristics and available unadjusted outcomes for episodes of care administered during COVID-19 using TR versus traditional in-person care, and (2) to describe TR frequency levels by condition and telecommunication modes. METHODS: A descriptive retrospective observational design was used to report patient variables and outcomes including physical function, number of visits, and patient satisfaction, by TR frequency (few, most, or all visits) and telecommunication modes. Standardized differences were used to compare baseline characteristics between episodes with and without TR. RESULTS: Sample consisted of 222,680 patients (59% female; mean [SD] age = 55 [18] years). Overall TR rate was 6% decreasing from 10% to 5% between second and third quarters of 2020. Outcome measures were available for 90% to 100% of episodes. Thirty-seven percent of clinicians administered care via TR. Patients treated using TR compared with in-person care were more likely to be younger and live in large metropolitan areas. From those with TR, 55%, 20%, and 25% had TR during few, most, or all visits, respectively. TR care was administered equally across orthopedic body parts, with lower use for nonorthopedic conditions such as stroke, edema, and vestibular dysfunction. TR was primarily administered using synchronous (video or audio) modes. The rate of patients reported being very satisfied with their treatment results was 3% higher for no TR compared with TR. CONCLUSIONS: These results provide new knowledge about to whom and how TR is being administered during the pandemic in outpatient rehabilitation practices throughout the United States. The database assessed was found to be suitable for conducting studies on associations between TR and diverse outcome measures, controlling for a comprehensive set of patient characteristics, to advance best TR care models, and promote high-quality care. IMPACT: This study provided detailed and robust descriptive information using an existing national patient database containing patient health and demographic characteristics, outcome measures, and telerehabilitation (TR) administration data. Findings support the feasibility to conduct future studies on associations between TR care and patient outcomes, adjusting for a wide range of patient characteristics and clinical setting factors that may be associated with the probability of receiving TR. The finding of limited and decreasing use of TR over the study period calls for studies aimed to better understand facilitators and inhibitors of TR use by rehabilitation therapists during everyday practice to promote its use when clinically appropriate.

The Lower Extremity Physical Function Patient-Reported Outcome Measure Was Reliable, Valid, and Efficient for Patients With Musculoskeletal Impairments.

OBJECTIVE: To calibrate the Lower Extremity Functional Scale (LEFS) items into a regional lower extremity physical function (LEPF) item bank and assess reliability, validity, and efficiency of computerized adaptive test (CAT) and short form (SF) administration modes. DESIGN: Retrospective cohort. SETTING: Data were collected from patients treated in outpatient rehabilitation clinics for musculoskeletal impairments of the hip, knee, foot, and ankle that responded to all 20 LEFS items at intake. PARTICIPANTS: Patients aged 14 years or older who started an episode of care during January 2016-October 2019 and identified the lower extremity region as the source of a primary musculoskeletal complaint. Total cohort included 78,186 patients (mean age, 53±19y, range, 14-89y). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Item response theory (IRT) model assumptions of unidimensionality, local item independence, item fit, and presence of differential item functioning (DIF) were studied. LEPF-CAT- and LEPF-SF-generated scores were evaluated. RESULTS: An 18-item solution was supported for its unidimensionality and fit to the IRT model, with reliability estimates >0.9 for all administration modes. No DIF impact on LEPF scores was identified. Scores discriminated between multiple patient groups in clinically logical ways and were highly responsive to change, with negligible floor or ceiling effects. CAT scores were generated using an average of 4.9 items (median, 4). CONCLUSIONS: The LEPF scores were reliable, valid, and efficient for assessing perceived physical function of patients with musculoskeletal impairments of the hip, knee, foot, and ankle; thus, it was found suitable for research and routine clinical administration. These findings are limited to the type of patients included in this study, with further validation needed to assess their generalizability.

Associations between interim patient-reported outcome measures and functional status at discharge from rehabilitation for non-specific lumbar impairments.

PURPOSE: Identify impact of frequency and timing of interim Patient-Reported Outcome Measures (PROMs) assessments during episodes of care for rehabilitation services in outpatient clinical settings on functional status (FS) outcomes at discharge for patients with low back pain. METHODS: FS outcomes of patients who had no interim PROMs were compared to outcomes of six patient groups defined by interim timing (early, mid, late) and frequency (1, 2 or more). For each comparison, patients were matched using propensity score matching for variables known to be associated with FS outcomes and for episode duration (days) and number of visits. FS was assessed using the lumbar computerized adaptive test (LCAT) where scores range from 0 to 100 with higher scores representing better physical function. RESULTS: A sample of 140,336 patients was considered for matching (mean age = 58 [SD = 17] range 18-89; 60% females) with 83,101 patients (59%) having no interim PROMs. Patients who had only one interim PROM, administered during early (first 2 weeks), mid (weeks 3-4), or late (week 5 or later) timing, had 4.6, 2.7, and 1.0 additional FS score points at discharge compared to those without an interim PROM, respectively (p < 0.001). Having two or more interim PROMs was associated with an additional 1.2 FS points compared to having only one interim assessment, but only if the first interim was administered early. CONCLUSIONS: Optimal utilization of interim PROM assessment during clinical practice to enhance treatment outcomes was related to administering the first interim PROM within the first 2 weeks after the initial evaluation.

Clinical Interpretation of the Neck Functional Status Computerized Adaptive Test.

BACKGROUND: Clinical interpretation of patient-reported outcome measures is an essential step in patient-centered care. Interpretation of scores derived from the Neck Functional Status Computerized Adaptive Test (NFS-CAT) has not been studied. OBJECTIVES: To (1) assess the reliability of point estimates and improvement scores, (2) determine thresholds of minimal clinically important improvement (MCII), and (3) develop a functional staging model to facilitate clinical interpretation of NFS-CAT scores. METHODS: A secondary retrospective cohort analysis was performed using data from patients aged 14 to 89 years who started an episode of care for neck impairments during 2016-2017 and completed the NFS-CAT at admission. The reliability of point estimates and of improvement scores was derived from the NFS-CAT standard error of measurement. The MCII was estimated by combining distribution- and anchor-based approaches. A functional staging model was developed to describe clinical meaningfulness of the quantitative scores provided by the NFS-CAT. RESULTS: Of 250 741 patients who completed the NFS-CAT at admission (mean ± SD age, 54 ± 16 years; 65% female), 169±039 (67%) also completed the NFS-CAT at discharge. The standard error of measurement was stable across the measurement continuum, ranging from 3.7 to 3.9 NFS-CAT points. Minimal detectable improvement was 6.8 points at the 90% confidence level. The estimate of the MCII was 8.1 points, with more change points needed to achieve the MCII for patients with lower baseline scores. Large rates of functional staging change during treatment were observed, demonstrating responsiveness of the functional staging model. CONCLUSION: This study demonstrated how the NFS-CAT can be interpreted to better assist clinicians and patients with neck impairments during outpatient rehabilitation. LEVEL OF EVIDENCE: Therapy, level 2b. J Orthop Sports Phys Ther 2019;49(12):875-886. Epub 10 Jul 2019. doi:10.2519/jospt.2019.8862.

Impact of Risk Adjustment on Provider Ranking for Patients With Low Back Pain Receiving Physical Therapy.

Background The impact of risk adjustment on clinic quality ranking for patients treated in physical therapy outpatient clinics is unknown. Objectives To compare clinic ranking, based on unadjusted versus risk-adjusted outcomes for patients with low back pain (LBP) who are treated in physical therapy outpatient clinics. Methods This retrospective cohort study involved a secondary analysis of data from adult patients with LBP treated in outpatient physical therapy clinics from 2014 to 2016. Patients with complete outcomes data at admission and discharge were included to develop the risk-adjustment model. Clinics with complete outcomes data for at least 50% of patients and at least 10 complete episodes of care per clinician per year were included for ranking assessment. The R2 shrinkage and predictive ratio were used to assess overfitting. Agreement between unadjusted and adjusted rankings was assessed with percentile ranking by deciles or 3 distinct quality ranks based on uncertainty assessment. Results The primary sample included 414 125 patients (mean ± SD age, 57 ± 17 years; 60% women) treated by 12 569 clinicians from 3048 clinics from all US states; 82% of patients from 2107 clinics were included in the ranking assessment. The R2 shrinkage was less than 1%, with a predictive ratio of 1. Risk adjustment impacted ranking for 70% or 31% of clinics, based on deciles or 3 distinct quality levels, respectively. Conclusion Important changes in ranking were found after adjusting for basic patient characteristics of those admitted to physical therapy for treatment of LBP. Risk-adjustment profiling is necessary to more accurately reflect quality of care when treating patients with LBP. Level of Evidence Therapy, level 2b. J Orthop Sports Phys Ther 2018;48(8):637-648. Epub 22 May 2018. doi:10.2519/jospt.2018.7981.

Calibration and validation of an item bank for measuring general physical function of patients in medical rehabilitation settings.

OBJECTIVE: The objective of this study was to report the item response theory (IRT) calibration of an 18-item bank to measure general physical function (GPF) in a wide range of conditions and evaluate the validity of the derived scores. METHODS: All 18 items were administered to a large sample of patients (n=2337) who responded to the items in the context of their outpatient rehabilitation care. The responses, collected 1997- 2000, were modeled using the graded response model, an IRT model appropriate for items with two or more response options. Inter-item consistency was evaluated based on Cronbach's alpha and item to total correlations. Validity of scores was evaluated based on known-groups comparisons (age, number of health problems, symptom severity). The strength of a single, general factor was evaluated using a bi-factor model. Results were used to evaluate IRT assumption and as an indicator of construct validity. Local independence of item responses was also evaluated. RESULTS: Response data met the assumptions of unidimensionality and local independence. Explained common variance of a single general factor was 0.88 (omega hierarchical =0.86). Only two of the 153 pairs of item residuals were flagged for local dependence. Inter-item consistency was high (0.93) as were item to total correlations (mean =0.61). Substantial variation was found in both IRT location (difficulty) and discrimination parameters. All omnibus known-groups comparisons were statistically significant (p<0.001). CONCLUSION: Item responses fit the IRT unidimensionality assumptions and were internally consistent. The usefulness of GPF scores in discriminating among patients with different levels of physical function was confirmed. Future studies should evaluate the validity of GPF scores based on an adaptive administration of items.

The Development and Psychometric Properties of the Patient Self-Report Neck Functional Status Questionnaire (NFSQ).

STUDY DESIGN: Retrospective analysis of cross-sectional data. OBJECTIVE: To describe the development of a new self-report Neck Functional Status Questionnaire (NFSQ) and to assess its psychometric properties and practical application. The NFSQ was designed to assess functional status in patients with cervical (spine) disorders who seek outpatient therapy. BACKGROUND: Many patients seek outpatient therapy due to cervical disorders. Currently, no patient-reported outcome measures exist that capture the ability to perform functional activity in a manner that reflects the experience of this patient population. METHODS: Four hundred thirty-nine patients who were being treated for cervical disorders responded to a set of survey questions to assess activity-related functional outcomes associated with cervical disorders. Using item response theory, we assessed candidate items for unidimensionality and local independence, item fit, person separation, precision, targeting, and differential item functioning. We also compared discriminant validity of functional status measures estimated by the item response theory model (NFSQ fixed) and measures generated using a simulated computerized adaptive test (NFSQ computerized adaptive test). RESULTS: Based on expert opinion and subsequent processing and analyses, a final set of 28 items was used to develop the NFSQ. Unidimensionality and local independence were supported. The mean ± SD sample ability level of 57.6 ± 14.3 (scale range, 0-100) matched well with the mean item difficulty of the NFSQ of 51.3 ± 7.4. Differential item functioning was negligible for levels of age group, sex, and symptom acuity. The NFSQ computerized adaptive test measures were as precise as the NFSQ fixed measures. CONCLUSION: Study results supported the preliminary validity of the 28-item NFSQ for use in assessing patients with different levels of functional status related to their cervical disorders in outpatient rehabilitation settings.

The self-report fecal incontinence and constipation questionnaire in patients with pelvic-floor dysfunction seeking outpatient rehabilitation.

BACKGROUND: Fecal incontinence and constipation affect men and women of all ages. OBJECTIVE: The purpose of this study was to psychometrically analyze the Fecal Incontinence and Constipation Questionnaire (FICQ) in patients seeking outpatient rehabilitation services due to pelvic-floor dysfunction (PFD). DESIGN: This was a retrospective analysis of cross-sectional data from 644 patients (mean age=52 years, SD=16, range=18-91) being treated for PFD in 64 outpatient rehabilitation clinics in 20 states (United States). METHODS: We assessed the 20-item FICQ for unidimensionality and local independence, differential item functioning (DIF), item fit, item hierarchical structure, and test precision using an item response theory model. RESULTS: Factor analyses supported the 2-factor subscales as originally defined; items related to severity of leakage or constipation. Removal of 2 leakage items improved unidimensionality and local independence of the leakage scale. Among the remaining items, 2 items were suggestive of adjustment for DIF by age group and by number of PFD comorbid conditions. Item difficulties were suitable for patients with PFD with no ceiling or floor effect. Mean item difficulty parameters for leakage and constipation subscales ranged from 38.8 to 62.3 and 28.1 to 63.3 (0-100 scale), respectively. Endorsed leakage items representing highest difficulty levels were related to delay defecation and confidence to control bowel leakage. Endorsed constipation items representing highest difficulty levels were related to the need to strain during a bowel movement and the frequency of bowel movements. LIMITATIONS: A limitation of this study was the lack of medical diagnostic criteria to classify patients. CONCLUSIONS: After removing 2 items and adjusting for DIF, the results supported sound psychometric properties of the FICQ items and its initial use for patients with PFD in outpatient rehabilitation services.

Psychometric properties and practicability of the self-report urinary incontinence questionnaire in patients with pelvic-floor dysfunction seeking outpatient rehabilitation.

BACKGROUND: Pelvic-floor dysfunction (PFD) affects a substantial proportion of individuals, mostly women. In responding to the demands in measuring PFD outcomes in outpatient rehabilitation, the Urinary Incontinence Questionnaire (UIQ) was developed by FOTO in collaboration with an experienced physical therapist who has a specialty in treating patients with PFD. OBJECTIVE: The purpose of this study was to evaluate psychometric properties and practicability of the 21-item UIQ in patients seeking outpatient physical therapy services due to PFD. DESIGN: This was a retrospective analysis of cross-sectional data from 1,628 patients (mean age=53 years, SD=16, range=18-91) being treated for their PFD in 91 outpatient physical therapy clinics in 24 states (United States). METHODS: Using a 2-parameter logistic item response theory (IRT) procedure and the graded response model, the UIQ was assessed for unidimensionality and local independence, differential item functioning (DIF), discriminating ability, item hierarchical structure, and test precision. RESULTS: Four items were dropped to improve unidimensionality and discriminating ability. Remaining UIQ items met IRT assumptions of unidimensionality and local independence. One item was adjusted for DIF by age group. Item difficulties were suitable for patients with PFD with no ceiling or floor effect. Item difficulty parameters ranged from -2.20 to 0.39 logits. Endorsed items representing highest difficulty levels were related to control urine flow, impact of leaking urine on life, and confidence to control the urine leakage problem. Item discrimination parameters ranged from 0.48 to 1.18. Items with higher discriminating abilities were those related to impact on life of leaking urine, confidence to control the urine leakage problem, and the number of protective garments for urine leakage. LIMITATIONS: Because this study was a secondary analysis of prospectively collected data, missing data might have influenced our results. CONCLUSIONS: Preliminary analyses supported sound psychometric properties of the UIQ items and their initial use for patients with PFD in outpatient physical therapy services.

Characteristics of patients seeking outpatient rehabilitation for pelvic-floor dysfunction.

BACKGROUND: Pelvic-floor dysfunction (PFD) affects a substantial proportion of individuals, especially women. OBJECTIVE: The purposes of this study were: (1) to describe the characteristics of individuals with disorders associated with PFD who were seeking outpatient physical therapy services and (2) to identify the prevalence of specific pelvic-floor disorders in the group. DESIGN: This was a prospective, longitudinal, cohort study of 2,452 patients (mean age=50 years, SD=16, range=18-91) being treated in 109 outpatient physical therapy clinics in 26 states (United States) for their PFD. METHODS: This study examined patient demographic variables and summarized patient self-reported responses to questions related to urinary and bowel functioning at admission prior to receiving the therapy for their PFD disorders. RESULTS: Patients primarily were female (92%), were under 65 years of age (39%: 18 to <45 years; 39%: 45 to <65 years; 21%: 65 years or older), and had chronic symptoms (74%). Overall, 67% of the patients reported that they had urinary problems, 27% reported bowel problems, and 39% had pelvic pain. Among those who had urinary or bowel disorders, 32% and 54% reported leakage and constipation, respectively, as their only problem. Among patients who had pelvic pain, most (56%) reported that the pain was in the abdominal area. Combinations of urinary, bowel, or pelvic-floor pain disorders occurred in 31% of the patients. LIMITATIONS: Because this study was a secondary analysis of data collected prospectively, the researchers were not in control of the data collection procedure. Missing data were common. CONCLUSIONS: Data suggested most patients with PFD receiving outpatient physical therapy services were female, younger than 65 years, and had disorders lasting for more than 90 days. Combinations of urinary, bowel, or pelvic-floor pain disorders were not uncommon.

Using intake and change in multiple psychosocial measures to predict functional status outcomes in people with lumbar spine syndromes: a preliminary analysis.

BACKGROUND: Managing patients with lumbar spine syndromes who are seeking outpatient physical therapy represents a complex problem where psychosocial constructs such as fear-avoidance beliefs regarding physical activities or work activities, somatization, and depressive symptoms may affect functional status (FS) outcomes. OBJECTIVE: The purpose of this study was to determine whether intake or changes in fear-avoidance beliefs regarding physical or work activities, somatization, and depressive symptoms assessed simultaneously affect FS outcomes prediction. DESIGN: This study was a secondary analysis of prospectively collected, longitudinal, observational cohort data. METHODS: Data analyzed were from adult patients (n=323) with lumbar syndromes classified as elevated versus not elevated on single-item screening instruments for fear-avoidance beliefs regarding physical or work activities, somatization, and depressive symptoms at intake and discharge. Prediction of minimal clinically important difference in FS was assessed separately for intake and change from intake to discharge classifications using logistic regression models controlling for important variables. RESULTS: Intake and change models were strong (McFadden rho-squared values=.31 and .49, respectively). Patients classified as not elevated in fear-avoidance beliefs regarding physical activities but elevated in fear-avoidance beliefs regarding work activities, somatization, and depressive symptoms at intake were 5 out of 100 times less likely to report clinically important outcomes compared with being elevated in each measure. Patients not elevated in fear-avoidance beliefs regarding work activities and somatization at intake and discharge were 8 to 14 times more likely to report clinically important outcomes compared with being elevated in each measure. LIMITATIONS: Sample size was limited. Data analyses were retrospective with no control of missing data. CONCLUSIONS: Combinations of multiple psychosocial constructs were important predictors of FS outcomes and may assist patient management by: (1) identifying patients with elevated psychosocial constructs at intake and (2) tracking change in psychosocial variables for improved outcomes prediction. This model may prove helpful for future clinical and research applications to determine optimal psychosocial screening methods.

Baseline dependency of minimal clinically important improvement.

BACKGROUND: Minimal clinically important improvement (MCII) is the smallest outcome measure change important to patients. Research suggests that MCII is dependent on patients' baseline functional status measures. OBJECTIVE: The purposes of this study were: (1) to confirm whether MCII is dependent on patients' admission scores and (2) to test whether MCII is dependent on selected demographic characteristics. STUDY DESIGN AND SETTING: This was a prospective, longitudinal, observational cohort study of 6,651 patients with orthopedic knee impairments treated in 332 outpatient rehabilitation clinics in 27 states in the United States. OUTCOME MEASURES: Patient self-reports of functional status (FS) from the Lower Extremity Functional Scale were assessed using a computerized adaptive testing application (0-100 scale). METHODS: An anchored-based longitudinal method, with a 15-point Likert-type scale (-7 to +7), was used to provide a global rating of change (GROC). The MCII threshold for the GROC was defined at a cut-score of +3 or greater and was determined using nonparametric receiver operating characteristic curve analysis for each of the following variables: sex, symptom acuity, age group, and quartile of baseline FS scores. RESULTS: The results showed that MCII was dependent on patient baseline and demographic characteristics. Patients who were male, were younger, had more-acute symptoms, or had lower FS scores at admission required more FS change to report meaningful change. LIMITATIONS: As this study was a secondary analysis, how the length of treatment mediated the relationship between the independent and dependent variables was unclear. CONCLUSIONS: Although a single MCII index may provide a standard cut-score defining the smallest FS change that is meaningful to patients, researchers and clinicians should be aware that MCII is context specific and not a fixed attribute. Current results may help researchers, clinicians, and policy makers to interpret FS change related to the importance of the change to the patient.

Translating shoulder computerized adaptive testing generated outcome measures into clinical practice.

STUDY DESIGN: Prospective longitudinal cohort study. INTRODUCTION: Increased use of computerized adaptive tests (CATs) to generate outcome measures during rehabilitation has stimulated questions concerning score interpretation. PURPOSE OF THE STUDY: The purpose of the study was to describe meaningful interpretations of scores from patient self-report shoulder functional status (FS) outcome measures estimated using a shoulder CAT (score range=0-100). METHODS: We applied four approaches to the clinical interpretation of outcomes data from 30,987 patients with shoulder impairments receiving outpatient rehabilitation in 518 clinics in 30 states (United States) between August 2007 and July 2009. First, we used standard error of estimates to construct 95% confidence intervals for each CAT estimated score. Second, we estimated the percentile rank (PR) of FS scores. Third, we used two threshold approaches to define individual patient-level change: statistically reliable change (i.e., minimal detectable change or MDC) and clinically important change. Fourth, we developed and applied a functional staging model, the Shoulder Function Classification System (SFCS). RESULTS: Precision of a single score was estimated by FS score ±4. Based on score distribution, 25th, 50th, and 75th PRs corresponded to intake FS scores of 43, 52, and 59 and discharge FS scores of 59, 68, and 80, respectively. MDC calculations indicated that changes in FS scores of 11 or more units represented statistically reliable change. FS score increments of eight or more units were estimated to represent minimal clinically important improvement based on receiver operating characteristic. The five-level SFCS was judged to be clinically logical and provide insight for clinical interpretation of patient progress. CONCLUSIONS: Results may improve clinical interpretation of CAT-generated outcome measures and assist clinicians using patient-reported outcomes during clinical practice. LEVEL OF EVIDENCE: Therapy level 2c.

Computerized adaptive test for patients with lumbar spine impairments produced valid and responsive measures of function.

STUDY DESIGN: Outcomes instrument validation study. OBJECTIVE: We evaluated administrative efficiency and psychometric adequacy of a computerized adaptive test (CAT) for patients with lumbar spine impairments seeking rehabilitation in outpatient therapy clinics. SUMMARY OF BACKGROUND DATA: CATs promise efficient outcomes data collection in clinical applications with little loss of measurement precision compared to paper and pencil surveys. The lumbar CAT has been developed and simulated and is currently used routinely in therapy clinics. The CAT has not been assessed for administrative efficiency, and the outcomes measures estimated using the CAT have not been assessed using prospective data collection for validity, sensitivity to change, or responsiveness. METHODS: Data from 17,439 patients with lumbar spine impairments receiving outpatient rehabilitation in 377 clinics in 30 states (United States) were analyzed. We evaluated efficiency of routine CAT administration and assessed construct validity, sensitivity to change, and responsiveness of CAT measures of lumbar functional status (FS). RESULTS: On average, patients took less than 2 minutes (standard deviation <1 minute) to answer 7 CAT items (standard deviation, 3), which produced precise estimates of FS that adequately covered the content range with negligible floor and ceiling effects. Patients who were older had more chronic symptoms, had more surgeries, had more comorbidities, and did not exercise before receiving rehabilitation reported worse discharge FS. A total of 66% of patients obtained statistically significant change (95% confidence interval minimal detectable change) at discharge. Change of 5 FS units (scale, 0-100) represented minimal clinically important improvement, which 70% of patients obtained. Minimal detectable change and minimal clinically important improvement were associated with intake FS. CONCLUSION: We concluded the lumbar CAT administration was efficient, and CAT FS measures were precise, valid, sensitive, and responsive, supporting lumbar CAT use in clinical and research applications.

Clinical interpretation of outcome measures generated from a lumbar computerized adaptive test.

BACKGROUND: A computerized adaptive test (CAT) provides a way of efficiently estimating functional status in people with specific impairments. OBJECTIVE: The purpose of this study was to describe meaningful interpretations of functional status (FS) estimated using a lumbar CAT developed using items from the Back Pain Functional Scale (BPFS) and selected physical functioning items. Design and Setting This was a prospective longitudinal cohort study of 17,439 patients with lumbar spine impairments in 377 outpatient rehabilitation clinics in 30 states. Outcome Measures Patient self-reports of functional status were assessed using a lumbar CAT (0-100 scale). METHODS: Outcome data were interpreted using 4 methods. First, the standard error of the estimate was used to construct a 95% confidence interval for each CAT estimated score. Second, percentile ranks of FS scores were presented. Third, 2 threshold approaches were used to define individual patient-level change: minimal detectable change (MDC) and clinically important change. Fourth, a functional staging model, the Back Pain Function Classification System (BPFCS), was developed and applied. RESULTS: On average, precision of a single score was estimated by FS score+/-4. Based on score distribution, 25th, 50th and 75th percentile ranks corresponded to intake FS scores of 44, 51, and 59, and discharge FS scores of 54, 62, and 74, respectively. An MDC(95) value of 8 or more represented statistically reliable change. Receiver operating characteristic analyses supported that changes in FS scores of 5 or more represented minimal clinically important improvement. The BPFCS appeared clinically logical and provided insight for clinical interpretation of patient progress. LIMITATIONS: The BPFCS should be assessed for validity using prospective designs. CONCLUSIONS: Results may improve clinical interpretation of CAT-generated outcome measures and assist clinicians using patient-reported outcomes during physical therapist practice.