Implementing electronic patient reported outcomes in inflammatory bowel disease: patient participation, score reliability and validity.

BACKGROUND: Patient-reported outcome measures (PROMs) are recommended for assessing patient-centered outcomes in inflammatory bowel disease (IBD). The main aims were to assess the level of participation in an electronic PROM (ePROM) data collection system among patients with IBD, and evaluate reliability and validity of the resulting scores. METHODS: Patients included in the IBD registry of Maccabi Healthcare Services, a state-mandated healthcare provider for over 2.6 million people in Israel, were invited to complete the IBD-Control measure and a general health item, with follow-up ePROMs at 3 and 6 months including a global rating of change item. Descriptive statistics were used to compare patient characteristics by participation rate, and assess survey completion time. Initial scores were assessed for internal consistency reliability using Cronbach's alpha. Test-retest reliability was assessed using the intraclass correlation coefficient from paired scores of patients identified as unchanged between the initial and first follow-up. Construct validity was assessed by the ability of IBD-control scores to discriminate between patient sub-groups in expected ways. Empirical validity was assessed using ePROM score correlations with laboratory markers of disease activity. Score coverage was also assessed. RESULTS: A total of 13,588 patients were invited to participate [Mean age = 49 years (SD = 17); females = 51%]. Participation rate was 31.5%. Participants compared to non-participants were slightly older, were more likely to be female, to have a history of biologic treatment, to have higher socio-economic status, and to be more experienced in the usage of the digital patient portal. Median survey completion time was approximately 1:30 min. Internal consistency and test-retest reliability were 0.86 and 0.98, respectively. Scores discriminated between patient sub-groups in clinically expected ways, with expected correlations to laboratory markers of disease activity. A notable ceiling effect was observed (> 15%) for IBD-Control scores. CONCLUSIONS: Feasibility, reliability, and validity of the ePROM system was supported for measuring the level of perceived disease control in patients diagnosed with IBD in Israel. Additional research is needed to identify ways to increase patient participation, assess clinical implications of the identified measurement ceiling of the IBD-control, and evaluate the added value of the derived scores in support of clinical decision making.

Lymphoedema, a significant health problem in Israel: A descriptive community-based study.

Lymphoedema (LE) is recognised as a chronic disabling disease. Knowledge on patient characteristics, treatments, and outcomes in Israel is lacking. The aim of the study was to (a) describe demographic and health characteristics, treatments, utilisation, and functional outcomes of patients receiving physical therapy due to LE in a large nationwide healthcare provider in Israel; and (b) assess the feasibility of conducting a future practice-based evidence (PBE) study. This is a retrospective observational cohort study. Descriptive analyses of an electronic medical record database were performed. Data from 6013 patient episodes were analysed. A high proportion of patients had two or more comorbidities (80%) and chronic medication use (85%) with increasing rates over the 8-year period. The most frequent LE classification was stage 2 (45%). A majority of LE was in the lower limbs (51%) with increasing rates over the years. The most frequent treatment-related activity was measuring limb circumference and the most frequent intervention was educating for self-management. This study provides a first comprehensive description of patient characteristics receiving physical therapy for LE in Israel. The available database offers an opportunity for PBE studies. Recommendations for improvements in specific data collection processes were identified.

Development of Reliable and Valid Negative Mood Screening Tools for Orthopaedic Patients with Musculoskeletal Pain.

BACKGROUND: Negative mood is an important risk factor for poor clinical outcomes among individuals with musculoskeletal pain. Screening for negative mood can aid in identifying those who may need additional psychological interventions. Limitations of current negative mood screening tools include (1) high response burden, (2) a focus on single dimensions of negative mood, (3) poor precision for identifying individuals with low or high negative mood levels, and/or (4) design not specific for use in populations with orthopaedic conditions and musculoskeletal pain. QUESTIONS/PURPOSES: (1) Can item response theory methods be used to construct screening tools for negative mood (such as depression, anxiety, and anger) in patients undergoing physical therapy for orthopaedic conditions? (2) Do these tools demonstrate reliability and construct validity when used in a clinical setting? METHODS: This was a cross-sectional study involving outpatients having physical therapy in tertiary-care settings. A total of 431 outpatients with neck (n = 93), shoulder (n = 108), low back (n = 119), or knee (n = 111) conditions were enrolled between December 2014 and December 2015, with 24% (103 of 431) seeking care after orthopaedic surgery. Participants completed three validated psychological questionnaires measuring negative mood, resulting in 39 candidate items for item response theory analysis. Factor analysis was used to identify the dimensions (factors) assessed by the candidate items and select items that loaded on the main factor of interest (negative mood), establishing a unidimensional item set. Unidimensionality of an item set suggests they are assessing one main factor or trait, allowing unbiased score estimates. The identified items were assessed for their fit to the graded item response theory model. This model allows for items to vary by the level of difficulty they represent and by their ability to discriminate between patients at different levels of the trait being assessed, in this case, negative mood. Finally, a hierarchical bifactor model where multiple subfactors are allowed to load on an overall factor was used to confirm that the items identified as representing a unidimensional item set explained the large majority of variance of the overall factor, providing additional support for essential unidimensionality. Using the final item bank, we constructed a computer adaptive test administration mode, and reduced item sets were selected to create short forms including items with the highest information (reliability) at targeted score levels of the trait being measured, while also considering clinical content. RESULTS: We identified a 12-item bank for assessment of negative mood; eight-item and four-item short-form versions were developed to reduce administrative burden. Computer adaptive test administration used a mean ± SD of 8 ± 1 items. The item bank's reliability (0 = no reliability; 1 = perfect reliability) was 0.89 for the computer adaptive test administration, 0.86 for the eight-item short form, and 0.71 for the four-item short form. Reliability values equal to or greater than 0.7 are considered acceptable for group level measures. Construct validity sufficient for clinical practice was supported by more severe negative mood scores among individuals with a previous episode of pain in the involved anatomical region, pain and activity limitations during the past 3 months, a work-related injury, education less than a college degree, and income less than or equal to USD 50,000. CONCLUSION: These newly derived tools include short-form and computer adaptive test options for reliable and valid negative mood assessment in outpatient orthopaedic populations. Future research should determine the responsiveness of these measures to change and establish score thresholds for clinical decision-making. CLINICAL RELEVANCE: Orthopaedic providers can use these tools to inform prognosis, establish clinical benchmarks, and identify patients who may benefit from psychological and/or behavioral treatments.

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.

Comparisons Between Illness and Injury Outcomes: Potential Suppression Effects by Emotional Representations.

BACKGROUND: Based on recent findings that people perceive illness and injury as separate categories, we compared ill and injured participants with similar health conditions on illness perceptions and reported outcomes, e.g., functioning, distress, well-being. METHOD: A cross-sectional study with 182 ill and 160 injured participants affected by ankle, knee, or neck conditions compared them on standard measures of illness perception and other reported outcomes (self-assessed health; physical, emotional, and social functioning; depression, anxiety, and somatization; satisfaction with life, self-esteem, and acceptance of disability). RESULTS: The groups did not differ on the measured outcomes, but injury elicited stronger emotional representations, and illness was perceived as more chronic. After controlling for the effects of emotional representations, the injured group presented better outcomes on all outcome measures, including self-assessed health, physical functioning, emotional functioning, social functioning, vitality, health beliefs, depression, somatization, total distress, and acceptance of disability. CONCLUSION: Emotional representations may suppress the potential superior outcomes of injury compared with illness. The theoretical implications of these results for self-regulation theories are discussed, as well as clinical implications.

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.

Treatment Documentation in Practice-Based Evidence Research for Patients Receiving Physical Therapy Because of Lymphedema.

OBJECTIVES: To describe development and testing of a physical therapy treatment code documentation taxonomy. DESIGN: Clinician survey within a practice-based evidence study framework for patients with lymphedema. SETTING: Outpatient physical therapy clinics within a large public health care service using a central electronic medical record. PARTICIPANTS: Certified lymphedema therapists (CLTs) (N=43). INTERVENTION: Treatment coding of 10 treatment vignettes representing real-life clinical scenarios. The CLTs were asked to accurately select 35 activity-intervention combination codes. MAIN OUTCOME MEASURES: The CLT score represented percentage of treatment codes accurately selected by each therapist. The code score represented percentage of CLTs who accurately selected each treatment code. RESULTS: The mean CLT score was 91%, with 72% of CLTs meeting the 90% criterion. Personal feedback was provided to each CLT. The mean code score was also 91%; with 71% of treatment codes meeting the 90% criterion. We identified 9 low-score codes needing additional education or found to be redundant. These codes were either clarified or removed. CONCLUSIONS: The proposed treatment code documentation system for lymphedema therapy was found to be clear and accurately used by most CLTs. Specific needs for improvement were identified. Follow-up testing is warranted to ensure ongoing accurate implementation of the treatment documentation system.

Traumatic Brain Injury Patient, Injury, Therapy, and Ancillary Treatments Associated With Outcomes at Discharge and 9 Months Postdischarge.

OBJECTIVE: To examine associations of patient and injury characteristics, inpatient rehabilitation therapy activities, and neurotropic medications with outcomes at discharge and 9 months postdischarge for patients with traumatic brain injury (TBI). DESIGN: Prospective, longitudinal observational study. SETTING: Inpatient rehabilitation centers. PARTICIPANTS: Consecutive patients (N=2130) enrolled between 2008 and 2011, admitted for inpatient rehabilitation after an index TBI injury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Rehabilitation length of stay, discharge to home, and FIM at discharge and 9 months postdischarge. RESULTS: The admission FIM cognitive score was used to create 5 relatively homogeneous subgroups for subsequent analysis of treatment outcomes. Within each subgroup, significant associations were found between outcomes and patient and injury characteristics, time spent in therapy activities, and medications used. Patient and injury characteristics explained on average 35.7% of the variation in discharge outcomes and 22.3% in 9-month outcomes. Adding time spent and level of effort in therapy activities and percentage of stay using specific medications explained approximately 20% more variation for discharge outcomes and 12.9% for 9-month outcomes. After patient, injury, and treatment characteristics were used to predict outcomes, center differences added only approximately 1.9% additional variance explained. CONCLUSIONS: At discharge, greater effort during therapy sessions, time spent in more complex therapy activities, and use of specific medications were associated with better outcomes for patients in all admission FIM cognitive subgroups. At 9 months postdischarge, similar but less pervasive associations were observed for therapy activities, but not classes of medications. Further research is warranted to examine more specific combinations of therapy activities and medications that are associated with better outcomes.

New Dizziness Impact Measures of Positional, Functional, and Emotional Status Were Supported for Reliability, Validity, and Efficiency.

Objective: To calibrate the 25 items from the Dizziness Handicap Inventory (DHI) patient-reported outcome measure (PROM), using item response theory (IRT), into 1 or more item banks, and assess reliability, validity, and administration efficiency of scores derived from computerized adaptive test (CAT) or short form (SF) administration modes. Design: Retrospective cohort study. Setting: Outpatient rehabilitation clinics. Participants: Patients (N=28,815; women=69%; mean age [SD]=60 [18]) included in a large national dataset and assessed for dizziness-related conditions who responded to all DHI items at intake. Interventions: Not applicable. Main Outcome Measures: IRT model assumptions of unidimensionality, local item independence, item fit, and presence of differential item functioning (DIF) were evaluated. Generated scores were assessed for reliability, validity, and administration efficiency. Results: Patients were treated in 976 clinics from 49 US states for either vestibular-, brain injury-, or neck-related impairments. Three unidimensional item banks were calibrated, creating 3 distinct PROMs for Dizziness Functional Status (DFS, 13 items), Dizziness Positional Status (DPS, 4 items), and Dizziness Emotional Status (DES, 6 items). Two items did not fit into any domain. A DFS-CAT and a DFS 7-item SF were developed. Except for 2 items by age groups and 1 item by main impairment, no items were flagged for DIF; DIF impact was negligible. Median reliability estimates were 0.91, 0.72, and 0.79 for the DFS, DPS, and DES, respectively. Scores discriminated between patient groups in clinically logical ways and had a large effect size (>0.8), with acceptable floor and ceiling effects (<15%), except for a floor effect for DPS (20.4%). DFS-CAT scores were generated using a median of 8 items; they correlated highly with full-bank scores (r=0.99). Conclusion: The 3 dizziness impact PROMs demonstrated moderate to high reliability, were valid, and highly responsive to change; thus, they are suitable for research and routine clinical administration.

Randomized trial of a comparison of rehabilitation or drug therapy for urgency urinary incontinence: 1-year follow-up.

INTRODUCTION AND HYPOTHESIS: Our goal was to compare the long-term efficacy of bladder training (BT), pelvic floor muscle training (PFMT), combined pelvic floor rehabilitation (CPFR), and drug therapy (DT) in patients with urgency urinary incontinence (UUI). METHODS: This multicenter single-blind randomized controlled trial compared the efficacy of BT, PFMT, DT, and CPFR at baseline and 3- and 12-month follow-ups. Outcome measures included number of voids/24 h, number of UUI episodes, Quality of Life related to UUI (QOL-rUI), urogynecologic visual analog scale, and self-reported function and disability. RESULTS: A significant improvement was found for all treatment groups at 3 and 12 months in urinary frequency, UUI episodes, QOL-rUI, and number of daily pads. Only CPFR showed a significant decrease of 4 voids/24 h and a significant increase in self-reported function. CONCLUSIONS: The study demonstrated long-term benefits of DT, BT, PFMT, and CPFR in the treatment of UUI with a slight advantage for CPFR.

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.

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.

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.

Single-item screens identified patients with elevated levels of depressive and somatization symptoms in outpatient physical therapy.

OBJECTIVE: Develop efficient and accurate screening tools to identify elevated levels of depressive or somatization symptoms, which can adversely affect functional status outcomes. METHODS: We conducted a secondary analysis of prospectively collected depressive and somatization symptoms (Symptom Checklist 90-Revised) data from 10,920 patients receiving outpatient physical therapy for a variety of neuromusculoskeletal diagnoses. Item response theory methods were used to analyze data, with particular emphasis on differential item functioning among groups of patients, and to identify potential screening items. Screening item accuracy for identifying patients with elevated symptoms was assessed with receiver-operating characteristic analyses. RESULTS: Seven items for depressive and 10 items for somatization symptoms represented unidimensional scales. Differential item functioning was negligible for demographic and clinical variables known to affect functional status outcomes. Items providing maximum information at the 88th percentile for depressive and 77th percentile for somatization scales accurately dichotomized patients into elevated versus not elevated symptom levels. CONCLUSIONS: Lack of differential item functioning suggested depressive and somatization screening could be useful in routine clinical practice and allowed the development of single-item screens that accurately identified patients with elevated depressive or somatization symptoms. Item response theory-based single-item screens may facilitate evaluation and management of heterogeneous populations receiving outpatient physical therapy.

Practice-based evidence research in rehabilitation: an alternative to randomized controlled trials and traditional observational studies.

Sound rigorous methods are needed by researchers and providers to address practical questions about risks, benefits, and costs of interventions as they occur in routine clinical practice such as: Are treatments used in daily practice associated with intended outcomes? For whom does an intervention work best? With limited clinical resources, what are the best interventions to use for specific types of patients? Answers to such questions can help clinicians, patients, researchers, and health care administrators learn from, and improve, real-world everyday clinical practice. In this article, we describe existing research designs to demonstrate clinical usefulness and comparative effectiveness of rehabilitation treatments. We compare randomized controlled trials and observational cohort studies of various types, including those that use instrumental variables or propensity scores to control for potential patient or treatment selection effects. We argue that practice-based evidence (PBE) study designs include features that address limitations inherent in both randomized trials and traditional observational studies, and also reduce the need for instrumental variables and propensity scores methods. We give examples of how PBE designs have been used in various rehabilitation areas to determine better treatments for specific types of patients.

Efficient Screening for Fear of Movement in Outpatient Settings: Short Form and Computer Adaptive Tests for Fear Avoidance and Negative Pain Coping.

OBJECTIVE: The purpose of this study was to develop screening measures using item response theory (IRT) for 2 factors highly relevant to fear of movement (FoM): fear avoidance and negative pain coping. METHODS: A total of 431 patients with neck (n = 93), shoulder (n = 108), low back (n = 119), or knee (n = 111) conditions seeking physical therapy completed 8 validated psychological questionnaires measuring fear avoidance and negative pain coping, resulting in 97 candidate items for IRT analysis. Unidimensionality and local independence were assessed using exploratory factor analyses followed by confirmatory factor analyses. Items were assessed for model fit to the graded response model for ordinal items. Using the final item bank, a computer adaptive test (CAT) administration mode was constructed, and reduced item sets were selected to create short forms (SFs), including items with highest information (reliability) at the different levels of the trait being measured while also considering clinical content. RESULTS: The results supported a 28-item bank for fear avoidance and 16-item bank for negative pain coping. A 10-item and 8-item SF were developed for fear avoidance and negative pain coping, respectively. Additionally, 4-item form versions were created to provide options with lower administrative burden. CAT administration used a mean (median) of 7.7 (8) and 7.0 (7) items for fear avoidance and negative pain coping, respectively. All factors demonstrated construct validity by discriminating patient groups in expected clinical patterns. CONCLUSION: These newly derived SFs and CAT administration modes provide reliable, valid, and efficient options to screen for fear avoidance and negative pain coping in populations with musculoskeletal pain. IMPACT: These tools, collectively referred to as the Screening for Pain Vulnerability and Resilience tools, address a critical need for standard FoM screening processes that aid in clinical decision-making to identify who might benefit from psychologically informed approaches.

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.

Effect of fear-avoidance beliefs of physical activities on a model that predicts risk-adjusted functional status outcomes in patients treated for a lumbar spine dysfunction.

STUDY DESIGN: Retrospective analysis of a prospective, longitudinal cohort study of 30 858 patients being treated for a lumbar spine dysfunction in outpatient physical therapy. OBJECTIVES: To determine effect of adding a single-item screening variable classifying patients with elevated versus not-elevated scores of fear-avoidance beliefs of physical activities at intake, on a model predicting risk-adjusted functional status (FS) outcomes. BACKGROUND: Outcomes must be risk-adjusted before making meaningful interpretations. Elevated fear-avoidance beliefs scores have been predictive of poor outcomes. But the importance of elevated fear-avoidance scores in a multivariable model predicting FS outcomes needs further study. METHODS: Using retrospective analyses, predictive ability (R2) of multivariable linear regression models of discharge FS with and without classification by elevated versus not-elevated fear-avoidance scores were compared, while controlling for intake FS, age, symptom acuity, surgical history, gender, number of comorbidities, and payer. Percent variance controlled and beta coefficients (95% confidence intervals) of each variable in both models were compared. A split-half design was used for model cross-validation. Predictive ratios (predicted FS, divided by actual discharge FS) were assessed. RESULTS: Adding fear-avoidance beliefs classification to the discharge FS model improved (P<.001) model predictive ability but only slightly (R2 without, and with, fear-avoidance classification, 0.2997 and 0.3010, respectively). Variables impacted models similarly (95% confidence intervals not different). Fear-avoidance classification added 0.2% data variance control to the existing model. Cross-validation was supported. Predictive ratios were 1.09 and 1.10, without and with fear-avoidance, respectively. CONCLUSION: Although screening for elevated fear-avoidance beliefs of physical activities significantly improves the FS outcomes predictive model, the amount of additional meaningful interpretation of FS outcomes was minimal. Exploration of other clinically relevant variables designed to improve outcomes prediction is warranted. LEVEL OF EVIDENCE: Prognosis, level 2c.

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.

Adjusting Quality Measures For Social Risk Factors Can Promote Equity In Health Care.

Risk adjustment of quality measures using clinical risk factors is widely accepted; risk adjustment using social risk factors remains controversial. We argue here that social risk adjustment is appropriate and necessary in defined circumstances and that social risk adjustment should be the default option when there are valid empirical arguments for and against adjustment for a given measure. Social risk adjustment is an important way to avoid exacerbating inequity in the health care system.