Outcome Measurement Research Articles

Clinical outcomes measurement in pediatric lower limb prosthetics: A scoping review.

This study aimed to identify clinical measures that have been used to evaluate function, health related quality of life (HRQoL), and/or satisfaction in children who use lower limb prostheses (LLP). The data reported on psychometric properties for children who use LLP were collected for each measure. First, PubMed, CINAHL, and Web of Science databases were searched using broad search terms to identify standardized outcome measures of function, HRQoL, and/or satisfaction with treatment used in pediatric LLP research published in 2001 or after. For each of the eligible measures found, a second search was performed to identify psychometric properties (e.g., validity, reliability) assessed with children who use LLP. Forty-four standardized outcome measures were identified from 41 pediatric LLP research articles. Five measures (i.e., Gait Outcomes Assessment for Lower Limb Differences, Functional Mobility Assessment, Child Amputee Prosthetics Project- Prosthesis Satisfaction Inventory, Child Amputee Prosthetics Project- Functional Scale Index, and Lower Limb Function Questionnaire) had data on psychometric properties for children who use LLP. Few studies report psychometric data for assessing the overall HRQoL, function, and/or satisfaction for children who use LLP. Further research is needed to validate or create new outcome measures that assess the HRQoL, satisfaction, and/or function of children who use LLP.

The association between pre‐diagnostic levels of psychological distress and adverse effects after radical prostatectomy

AbstractObjectivesTo prospectively analyse the associations between pre‐diagnostic levels of anxiety and depression and patient‐reported urinary and sexual adverse effects after radical prostatectomy in a population‐based setting.Patients and MethodsIn three Norwegian county hospitals, men referred with a suspicion of prostate cancer were asked to fill out a patient‐reported outcome measurement (PROM) questionnaire prior to prostate biopsy. Those who later underwent radical prostatectomy were stratified into three distress groups according to their Hopkins Symptom Checklist 5‐score. Additional PROM questionnaires, including the EPIC‐26 to measure adverse effects, were collected at 6 and 12 months postoperatively. Multivariable mixed models were estimated and post hoc pairwise comparisons performed to explore differences in adverse effects between distress groups.ResultsA total of 416 men were included at baseline and of those, 365 (88%) returned questionnaires at 6 months and 360 (87%) at 12 months. After adjusting for confounders, men with high distress at baseline had worse urinary incontinence domain score (58.9 vs. 66.8, p = 0.028), more urinary bother (64.7 vs. 73.6, p = 0.04) and a higher risk of using incontinence pads (70.6% vs. 54.2%, p = 0.034) at 6 months than those with low distress. There was no difference in the sexual domain scores between distress groups postoperatively, but the high‐distress group expressed more sexual bother (24.9 vs. 37.5, p = 0.015) and the intermediate‐distress group had a greater probability of using sexual medications or devices (63.8% vs. 50.0%, p = 0.015) than the low‐distress group at 6 months. At 12 months scores generally improved slightly and differences between distress groups were less evident.ConclusionMen with higher levels of anxiety and depression before prostate biopsy report more urinary and sexual adverse effects after radical prostatectomy. This should be considered both in treatment decision‐making and during follow‐up after radical prostatectomy.

Using PROMIS Scores to Provide Cost-Conscious Follow-up After Foot and Ankle Surgery.

National campaigns in the United States, such as Choosing Wisely, emphasize that decreasing low-value office visits maximizes health care value. Although patient-reported outcomes (PROs) are frequently used to quantify postoperative outcomes, they have not been assessed as a tool to help guide clinicians consider alternatives or discontinue in-person follow-up visits. The purpose of this study is to assess the frequency and cost of in-person follow-up visits after patients report substantial improvement defined as 2 consecutive improvements above preoperative Patient Reported Outcomes Measurement Information System (PROMIS) pain interference (PI) scores. Retrospective PROMIS PI data were obtained between 2015 and 2020 for common elective foot (n = 759) and ankle (n = 578) surgical procedures. Patients were divided into quartiles according to their preoperative PI score. Multivariable Cox proportional hazards models were used to investigate time to substantial improvement. Substantial improvement was defined as having 2 consecutive postoperative minimal clinically important differences (MCIDs) above preoperative PROMIS PI scores. MCID was measured using the distribution-based method. Multivariable negative binomial models were used to determine the number of visits and direct associated costs after substantial improvement. The cost to payors was estimated using reimbursement rates. Within 3 months, 12% to 46% of foot and 16% to 61% of ankle patients achieved substantial improvement. Results vary by preoperative pain quartile, with patients who report higher preoperative pain scores achieving earlier improvement. After achieving substantial improvement, foot and ankle patients averaged 3.60 and 4.01 follow-up visits during the remaining 9 months of the year. Visit costs averaged $266 and $322 per foot and ankle patient respectively. Postoperative follow-up visits are time-consuming and costly. Physicians might consider objective measures, such as PROMIS PI, to determine the need, timing, and alternatives for in-person follow-up visits for elective foot and ankle surgeries after patients demonstrate reliable clinical improvement. Level III, retrospective cohort study at a single institution.

What are patients' perspectives on the value of physical therapy? A prospective cohort study.

To assess and identify patients' perceptions about the overall value of physical therapy services for musculoskeletal conditions and how these values were associated with their outcomes. The association between the perceived value of physical therapy (as a score) and Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and physical function at 6-weeks was assessed in a prospective cohort. Generalised linear models were used to identify relationships between the value of physical therapy score and PROMIS outcomes. Kendall's tau was used to identify correlations between responses and outcomes. A total of 133 participants met the final inclusion criteria. The majority of participants were female (63.9%) with a mean age of 55.53 (SD 15.36) years. A majority of participants (63.9%) reported a previous positive personal experience with physical therapy. There was no significant relationship between perceived value of physical therapy and pain interference (β -0.32, p=0.07, 95% CI-0.67, 0.03) or physical function (β 0.19, p=0.29, 95% CI-0.16, 0.54). Stronger beliefs in agreement with the value of non-invasive treatment were significant, but weakly correlated with lower pain interference (r=-0.18, p=0.048) and higher physical function scores (r=0.22, p=0.03). Participants had an overall positive perception of the value of physical therapy prior to initiating physical therapy, but this perception was not associated with 6-week pain and function outcomes. A better understanding of the driving factors encouraging patients to seek physical therapy services is needed to provide value-based care.

Seroma control in axillary lymphadenectomy with Glubran 2® without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain)

BackgroundSeroma after breast cancer surgery is a frequent entity; therefore, different products have been described in literature with the aim to reduce it. The most studied ones have been the sealants products, being tested with aspirative drains. Symptomatic seroma represents the 19% after axillary lymphadenectomy without drains. The aim of this study is to analyze the effect of a sealant in the seroma control after axillary lymphadenectomy without drains and identify the risk factors related to symptomatic seroma.MethodsThis is a prospective, multicenter, international, and randomized clinical trial. Patients undergoing conservative surgery and axillary lymphadenectomy for breast cancer will be randomized to control group (lymphadenectomy without sealant) or interventional group (lymphadenectomy with sealant Glubran 2®). In any of the study groups, drains are placed. Patients who received neoadjuvant treatment are included. Measurements of the study outcomes will take place at baseline; at 7, 14, and 30 days post-surgery; and at 6–12 months. The primary outcome is symptomatic seroma. Secondary outcomes are seroma volume, morbidity, quality of life, and lymphedema.DiscussionSeveral studies compare the use of sealant products in axillary lymphadenectomy but generally with drains. We would like to demonstrate that patients who underwent axillary lymphadenectomy could benefit from an axillary sealant without drains and reduce axillary discomfort while maintaining a good quality of life. Assessing the relationship between axillary volume, symptoms, and related risk factors can be of great help in the control of seroma in patients who received breast cancer surgery.Trial registrationClinicalTrials.gov, NCT05280353. Registration date 02 August 2022.

Integrating large language models in systematic reviews: a framework and case study using ROBINS-I for risk of bias assessment

Large language models (LLMs) may facilitate and expedite systematic reviews, although the approach to integrate LLMs in the review process is unclear. This study evaluates GPT-4 agreement with human reviewers...

Impact of psychosocial factors on the success of neuromodulation treatment for patients with persistent pain

IntroductionSignificant interindividual variability in spinal cord stimulation (SCS) outcomes exists. Due to its high cost and risks of complications, criteria to guide patient selection for SCS trials and their outcomes...

How to Monitor Disease Activity of Axial Spondyloarthritis in Clinical Practice.

Treatment guided by periodic and quantitative data assessment results in better outcomes compared to using clinical gestalt. While validated generic as well as specific disease activity measures for axial spondyloarthritis (axSpA) are available, there is vast scope to improve their actual utilization in routine clinical practice. In this review, we discuss available disease activity measures for axSpA, describe results from the survey conducted among general rheumatologists as well as Spondyloarthritis Research and Treatment Network (SPARTAN) members about disease activity measurement in daily practice, and discuss ways to improve axSpA disease activity using technological advances. We also discuss the definitions of active disease and target for the treatment of axSpA. The 2019 American College of Rheumatology (ACR)/Spondylitis Association of America (SAA)/Spondyloarthritis Research and Treatment Network (SPARTAN) axSpA treatment guidelines conditionally recommend the regular monitoring of disease activity using a validated measure such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or Ankylosing Spondylitis Disease Severity Index (ASDAS). Assessment of Spondyloarthritis International Society (ASAS)-European Alliance of Associations for Rheumatology (EULAR) guidelines recommend ASDAS as the most appropriate instrument for the assessment of disease activity, preferably calculated using C-reactive protein (CRP). ASAS has selected a core set of variables which were updated recently and have been endorsed by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) group in order to bring homogeneity in assessment of axSpA. In a recent study, Patient-Reported Outcomes Measurement Information System (PROMIS®) measures were able to discriminate inactive, moderate, and high-very high ASDAS activity groups. A newly developed semi-objective index P4 (pain, physical function, patient global, and physician global) correlates well with BASDAI and ASDAS in axSpA and can also be used for other rheumatic diseases in busy clinical practices. Regular disease activity monitoring is critical for long-term management of axSpA and shared decision-making. The integration of electronic health records and smart devices provides a great opportunity to capture patient-reported data. Automated capture of electronic patient-reported outcome measures (ePROMs) is a highly efficient way and results in consistent regular monitoring and may improve the long-term outcomes. While currently used measures focus only on musculoskeletal symptoms of axSpA, a composite disease activity measure that can also incorporate extra-articular manifestations may provide a better assessment of disease activity.

The Ankle Ligament Reconstruction-Return to Sport after Injury (ALR-RSI) is a valid and reliable measure to assess psychological readiness before returning to sport following peroneal tendon pathology surgery.

The objective of this study was to validate a scale that could help surgeons evaluate patients' psychological readiness to return to sport (RTS) after peroneal tendon pathology surgery. The Ankle Ligament Reconstruction-Return to Sport after Injury (ALR-RSI) scale, which had previously been validated in ankle ligament reconstruction patients, was adapted to evaluate the psychological preparedness for RTS in athletic patients who underwent peroneal tendinopathy surgery. The Foot and Ankle Outcome Score (FAOS) and Foot Ankle Ability Measurement (FAAM) scores were employed as patient-related outcome measurement (PROM) instruments. This study included 57 patients. There was a strong correlation between ALR-RSI and both FAOS and FAAM (r = -0.68 and 0.74, respectively). ALR-RSI was considerably higher in patients who returned to sports than in those who did not. The mean score was 72.9 ± 19.0 in patients who returned to the same preinjury level, 48.5 ± 24.0 in those who returned to a lower leveland 53.6 ± 31.1 in patients who changed their athletic activity (p < 0.0001). Furthermore, ALR-RSI showed at least a similar discrimination ability when compared to FAOS and FAAM. The test-retest intraclass correlation coefficient was 0.95. The Cronbach's α statistic used to measure the internal consistency was high (0.95). A Youden index of 0.65 was observed for a cut-off score of 68 points. ALR-RSI is a valid instrument for assessing psychological readiness to RTS in an athletic population following peroneal tendon surgery. When compared to the most commonly used PROMs, it was strongly correlated and demonstrated at least similar discrimination capacity. This could assist surgeons in identifying athletes who will have poor postoperative results and advising them on their capability to RTS. Level III.

A Digital Intervention to Promote Self-Management Self-Efficacy Among Community-Dwelling Individuals With Stroke: Pilot Randomized Controlled Trial.

Digital interventions provided through smartphones or the internet that are guided by a coach have been proposed as promising solutions to support the self-management of chronic conditions. However, digital intervention for poststroke self-management is limited; we developed the interactive Self-Management Augmented by Rehabilitation Technologies (iSMART) intervention to address this gap. This study aimed to examine the feasibility and initial effects of the iSMART intervention to improve self-management self-efficacy in people with stroke. A parallel, 2-arm, nonblinded, randomized controlled trial of 12-week duration was conducted. A total of 24 participants with mild-to-moderate chronic stroke were randomized to receive either the iSMART intervention or a manual of stroke rehabilitation (attention control). iSMART was a coach-guided, technology-supported self-management intervention designed to support people managing chronic conditions and maintaining active participation in daily life after stroke. Feasibility measures included retention and engagement rates in the iSMART group. For both the iSMART intervention and active control groups, we used the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure to assess the feasibility, acceptability, and appropriateness, respectively. Health measures included the Participation Strategies Self-Efficacy Scale and the Patient-Reported Outcomes Measurement Information System's Self-Efficacy for Managing Chronic Conditions. The retention rate was 82% (9/11), and the engagement (SMS text message response) rate was 78% for the iSMART group. Mean scores of the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure were 4.11 (SD 0.61), 4.44 (SD 0.73), and 4.36 (SD 0.70), respectively, which exceeded our benchmark (4 out of 5), suggesting high feasibility, acceptability, and appropriateness of iSMART. The iSMART group showed moderate-to-large effects in improving self-efficacy in managing emotions (r=0.494), symptoms (r=0.514), daily activities (r=0.593), and treatments and medications (r=0.870), but the control group showed negligible-to-small effects in decreasing self-efficacy in managing emotions (r=0.252), symptoms (r=0.262), daily activities (r=0.136), and treatments and medications (r=0.049). In addition, the iSMART group showed moderate-to-large effects of increasing the use of participation strategies for management in the home (r=0.554), work (r=0.633), community (r=0.673), and communication activities (r=0.476). In contrast, the control group showed small-to-large effects of decreasing the use of participation strategies for management in the home (r=0.567), work (r=0.342, community (r=0.215), and communication activities (r=0.379). Our findings support the idea that iSMART was feasible to improve poststroke self-management self-efficacy. Our results also support using a low-cost solution, such as SMS text messaging, to supplement traditional therapeutic patient education interventions. Further evaluation with a larger sample of participants is still needed. ClinicalTrials.gov 202004137; https://clinicaltrials.gov/study/NCT04743037?id=202004137&rank=1.

Mid-term outcomes of a kinematically designed cruciate retaining total knee arthroplasty.

Advances in implant material and design have allowed for improvements in total knee arthroplasty (TKA) outcomes. A cruciate retaining (CR) TKA provides the least constraint of TKA designs by preserving the native posterior cruciate ligament. Limited research exists that has examined clinical outcomes or patient reported outcome measures (PROMs) of a large cohort of patients undergoing a CR TKA utilizing a kinematically designed implant. It was hypothesized that the studied CR Knee System would demonstrate favorable outcomes and a clinically significant improvement in pain and functional scores. To assess both short-term and mid-term clinical outcomes and PROMs of a novel CR TKA design. A retrospective, multi-surgeon study identified 255 knees undergoing a TKA utilizing a kinematically designed CR Knee System (JOURNEY™ II CR; Smith and Nephew, Inc., Memphis, TN) at an urban, academic medical institution between March 2015 and July 2021 with a minimum of two-years of clinical follow-up with an orthopedic surgeon. Patient demographics, surgical information, clinical outcomes, and PROMs data were collected via query of electronic medical records. The PROMs collected in the present study included the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) and Patient-Reported Outcomes Measurement Information System (PROMIS®) scores. The significance of improvements in mean PROM scores from preoperative scores to scores collected at six months and two-years postoperatively was analyzed using Independent Samples t-tests. Of the 255 patients, 65.5% were female, 43.8% were White, and patients had an average age of 60.6 years. Primary osteoarthritis (96.9%) was the most common primary diagnosis. The mean surgical time was 105.3 minutes and mean length of stay was 2.1 d with most patients discharged home (92.5%). There were 18 emergency department (ED) visits within 90 d of surgery resulting in a 90 d ED visit rate of 7.1%, including a 2.4% orthopedic-related ED visit rate and a 4.7% non-orthopedic-related ED visit rate. There were three (1.2%) hospital readmissions within 90 d postoperatively. With a mean time to latest follow-up of 3.3 years, four patients (1.6%) required revision, two for arthrofibrosis, one for aseptic femoral loosening, and one for peri-prosthetic joint infection. There were significant improvements in KOOS JR, PROMIS Pain Intensity, PROMIS Pain Interference, PROMIS Mobility, and PROMIS Physical Health from preoperative scores to six month and two-year postoperative scores. The evaluated implant is an effective, novel design offering excellent outcomes and low complication rates. At a mean follow up of 3.3 years, four patients required revisions, three aseptic and one septic, resulting in an overall implant survival rate of 98.4% and an aseptic survival rate of 98.8%. The results of our study demonstrate the utility of this kinematically designed implant in the setting of primary TKA.

Predictive Criterion Validity of the Parsley Symptom Index Against the Patient-Reported Outcomes Measurement Information System-10 in a Chronic Disease Cohort: Retrospective Cohort Study.

Approximately 60% of US adults live with chronic disease, imposing a significant burden on patients and the health care system. With the rise of telehealth, patient-reported outcomes measures (PROMs) have emerged as pivotal tools for managing chronic disease. While numerous PROMs exist, few have been designed explicitly for telehealth settings. The Parsley Symptom Index (PSI) is an electronic patient-reported outcome measure (ePROM) developed specifically for telehealth environments. Our aim is to determine whether the PSI predicts changes in the established Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) Global Health, a 10-question short form. We conducted a retrospective cohort study using data from 367 unique patients, amassing 1170 observations between August 30, 2017, and January 30, 2023. Patients completed the PSI and the PROMIS-10 multiple times throughout the study period. Using univariate regression models, we assess the predictive criterion validity of the PSI against PROMIS-10 scores. This study revealed significant relationships between the PSI and PROMIS-10 physical and mental health scores through comprehensive univariate analyses, thus establishing support for the criterion validity of the PSI. These analyses highlighted the PSI's potential as an insightful tool for understanding and predicting both mental and physical health dimensions. Our findings emphasize the importance of the PSI in capturing the nuanced interactions between symptomatology and health outcomes. These insights reinforce the value of the PSI in clinical contexts and support its potential as a versatile tool in both research and practice.

Exploring the Interrelationships Between Physical Function, Functional Exercise Capacity, and Exercise Self-Efficacy in Persons Living with HIV.

To determine if there were differences between the subjective and objective assessments of physical activity while controlling for sociodemographic, anthropometric, and clinical characteristics. A total of 810 participants across eight sites located in three countries. Subjective instruments were the two subscales of Self-efficacy for Exercise Behaviors Scale: Making Time for Exercise and Resisting Relapse and Patient-Reported Outcomes Measurement Information System, which measured physical function. The objective measure of functional exercise capacity was the 6-minute Walk Test. Both univariate and multivariant analyses were used. Physical function was significantly associated with Making Time for Exercise (β = 1.76, p = .039) but not with Resisting Relapse (β = 1.16, p = .168). Age (β = -1.88, p = .001), being employed (β = 16.19, p < .001) and race (βs = 13.84-31.98, p < .001), hip-waist ratio (β = -2.18, p < .001), and comorbidities (β = 7.31, p < .001) were significant predictors of physical functioning. The model predicting physical function accounted for a large amount of variance (adjusted R2 = .938). The patterns of results predicting functional exercise capacity were similar. Making Time for Exercise self-efficacy scores significantly predicted functional exercise capacity (β = 0.14, p = .029), and Resisting Relapse scores again did not (β = -0.10, p = .120). Among the covariates, age (β = -0.16, p < .001), gender (β = -0.43, p < .001), education (β = 0.08, p = .026), and hip-waist ratio (β = 0.09, p = .034) were significant. This model did not account for much of the overall variance in the data (adjusted R2 = .081). We found a modest significant relationship between physical function and functional exercise capacity (r = 0.27). Making Time for Exercise Self-efficacy was more significant than Resisting Relapse for both physical function and functional exercise capacity. Interventions to promote achievement of physical activity need to use multiple measurement strategies.

Effects of Group Exercise Intervention on Quality of Life and Physical Parameters in Patients with Childhood Cancer: A Systematic Review.

Although the survival rates of childhood cancer are increasing, children diagnosed as having cancer experience psychological and physical problems and a declining quality of life (QOL). A systematic review of PubMed databases was conducted up to September 2023 to identify studies reporting the effects of group exercise intervention in children with cancer. The inclusion criteria were pre-specified, including children aged ≤19 years old who received group exercise intervention and interventional studies written in English. Studies involving non-exercise intervention or non-group intervention were excluded. Five studies were included in the present review. In three studies, QOL and physical parameters were improved after group exercise intervention, and in two studies, only physical parameters were improved. Improvements in QOL were achieved through psychosocial variables, improved scores of subscales of pain and hurt, nausea, and procedure-related anxiety, and reduced cancer-related fatigue. All studies had high numbers of participants who completed the intervention. However, all studies showed a high risk of bias regarding the selection of the reported results, and most studies showed a high risk of bias regarding deviations from the intended intervention and outcome measurement. The reviewed studies showed that group exercise intervention for children with cancer could improve their QOL and/or physical parameters.

Core outcome measurement set for research and clinical practice in post-COVID-19 condition (long COVID) in children and young people: an international Delphi consensus study "PC-COS Children".

The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of children and young people with post-COVID-19. To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in children and young people. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined core outcomes from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72%) contributing to both Delphi rounds. The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments. As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: PedsQL multidimensional fatigue scale for "fatigue"; PedsQL gastrointestinal symptom scales for "gastrointestinal"; PedsQL cognitive functioning scale for "neurocognitive" and EQ-5D for "physical functioning". Despite proposing outcome measurement instruments for the remaining three core outcomes ("cardiovascular", "post-exertional malaise", "work/occupational and study changes"), a consensus was not achieved. Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in children and young people in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide.

Validation of the Oswestry Disability Index in Adult Spinal Deformity.

Retrospective cohort. To examine the validity of the Oswestry Disability Index (ODI) in patients with adult spinal deformity (ASD) treated with surgery. The ODI is a patient-reported outcome measure of low back pain and disability. Although nearly ubiquitous in ASD research, the measure has not been validated in this patient population. A registry of patients with ASD was queried for baseline and 1-year PROM data, including the ODI, the Scoliosis Research Society-22r (SRS-22r), and the Patient Reported Outcomes Measurement Information System-Pain Interference (PI) and Physical Function (PF) CATs. Internal reliability was assessed with Cronbach alpha, where values ≥0.7 are considered reliable. Validity was assessed with Spearman correlation coefficients calculated for the ODI against validated Patient-Reported Outcomes Measurement Information System (PROMIS)-PI and PF, and legacy measures SRS-Pain and SRS-Activity. Responsiveness to change was measured with the adjusted effect size. A total of 325 patients were enrolled, with 208 completing baseline and 1-year patient-reported outcome measures. The majority (149, 72%) were females and White (193, 93%), median Charlson Comorbidity Index 0 (interquartile range: 0-2). The majority of cases included sagittal plane deformity [mean T1PA: 24.2° (13.9)]. Cronbach alpha showed excellent internal reliability (baseline = 0.89, 1 yr = 0.90). ODI was valid, with strong correlations between PROMIS-PI, PROMIS-PF, SRS-Pain, and SRS-Activity at baseline and 1-year follow-up. All measures were responsive to change, with the ODI showing greater responsiveness than PROMIS-PI, PROMIS-PF, and SRS-Activity. The ODI is a valid measure of disability as measured by pain and function in patients with ASD. It is responsive to change in a manner not different from validated PROMIS-CAT or the SRS-22r legacy measure. It is multidimensional, however, as it assesses both pain and function simultaneously. It does not measure disability related to self-image and may not account for all disease-related disability in patients with ASD.

The Promising 2-Year Performance of the Patient-Reported Outcomes Measurement Information System in Primary Hip Arthroscopy for Femoroacetabular Impingement Syndrome

Background: Minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds have been previously defined for the Patient-Reported Outcomes Measurement Information System (PROMIS) at 1-year follow-up in patients undergoing hip arthroscopy for femoroacetabular impingement syndrome; however, the MCID and PASS thresholds are yet to be defined for the PROMIS at 2-year follow-up. Purpose: (1) To establish MCID and PASS thresholds for the PROMIS Pain Interference (PROMIS-PI) and PROMIS Physical Function (PROMIS-PF) at 2-year follow-up and (2) to correlate PROMIS scores with hip-specific patient-reported outcome measure (PROM) scores. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: Patients undergoing primary hip arthroscopy for femoroacetabular impingement syndrome between August and November 2020 with preoperative and minimum 2-year postoperative data were identified. Collected scores included those for the PROMIS-PI, PROMIS-PF, Hip Outcome Score–Activities of Daily Living (HOS-ADL), Hip Outcome Score–Sports Subscale (HOS-SS), International Hip Outcome Tool–12 (iHOT-12), and visual analog scale (VAS) for pain. MCID thresholds were calculated using the distribution-based method and PASS thresholds using the anchor-based method. Pearson correlation coefficients were used to compare scores between PROMs. Results: A total of 65 patients met the criteria for inclusion (72.3% female; mean age, 36.9 ± 13.5 years; mean body mass index, 26.2 ± 6.0). The mean follow-up was 25.3 ± 3.3 months. Significant preoperative to postoperative improvements were observed for all PROMs (P < .001). MCID thresholds and achievement rates were as follows: HOS-ADL, 10.1 and 75%, respectively; HOS-SS, 13.8 and 79%, respectively; iHOT-12, 14.0 and 67%, respectively; VAS pain, –13.8 and 78%, respectively; PROMIS-PI, –4.7 and 65%, respectively; and PROMIS-PF, 5.8 and 60%, respectively. PASS thresholds and achievement rates were as follows: HOS-ADL, 78.7 and 67%, respectively; HOS-SS, 76.4 and 62%, respectively; iHOT-12, 67.4 and 60%, respectively; VAS pain, 25.5 and 61%, respectively; PROMIS-PI, 57.0 and 65%, respectively; and PROMIS-PF, 45.6 and 58%, respectively. PROMIS-PI scores correlated most strongly with HOS-ADL (r = −0.836), HOS-SS (r = −0.767), and iHOT-12 (r = −0.719) scores and exhibited at least moderate correlations (r≥−0.595) with the other PROM scores. PROMIS-PF demonstrated moderate correlations with all the other PROM scores (r≥−0.586). Strong correlations were seen between the hip-specific PROM scores (r≥−0.745). Conclusion: This study defined 2-year MCID and PASS thresholds for the PROMIS-PI and PROMIS-PF and demonstrated moderate to strong correlations between PROMIS scores and hip-specific PROM scores.

Development and initial validation of the AL-PROfile patient-reported outcome measure in light chain (AL) amyloidosis.

To evaluate the psychometric properties of the AL-PROfile, a patient-reported outcome measure combining the Patient-Reported Outcomes Measurement Information System (PROMIS)-29, two items from PROMIS Cognitive Function, and select Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items. Content validity was assessed through cognitive debriefing interviews of 20 patients who completed the AL-PROfile (Study 1). Study 2 involved 297 participants who completed the AL-PROfile and Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Reliability (internal consistency and test-retest reliability) and validity (convergent and discriminant validity, known groups validity by stage/organ involvement) were calculated. Study 1 participants found the AL-PROfile straightforward confirming the relevance of the included content. Some felt that certain questions were not related to their amyloidosis experience. Study 2 demonstrated acceptable internal consistency for all domains/items except PROMIS Cognitive Function and acceptable test-retest reliability for all except PROMIS Cognitive Function and PRO-CTCAE nausea. Large correlations were seen for the same domain across measures while correlations for divergent domains within a measure and different domains across different measures were small. The PRO-CTCAE items showed small to medium correlations with each other and with PROMIS and SF-36 domains. Stage was associated with physical function, fatigue, social roles, swelling, and shortness of breath scores. The AL-PROfile has acceptable reliability and validity for use in systemic light chain amyloidosis patients.

Increased Confidence and Deeper Understanding of Fatigue Following Participation in Fatigue Education and Management Education in Systemic Sclerosis: A Mixed Methods Evaluation of a Virtual Intervention.

No fatigue-specific programs exist for people with systemic sclerosis (SSc) despite the burden of fatigue and negative impact on daily activities. This study used a convergent parallel mixed methods design to evaluate the impact of an adapted virtual intervention, Fatigue and Activity Management Education in Systemic Sclerosis (FAME-iSS), in the United States. Eighteen people with SSc participated in three separate six-week FAME-iSS programs. Participants completed the modified Fatigue Impact Scale (m-FIS), the Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPESCA), the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms, and the Hospital Anxiety and Depression Scale (HADS) before, immediately after, and three months post intervention. Data were analyzed using descriptive and nonparametric inferential statistics. Participants' perceptions of the program and their use of fatigue management strategies were qualitatively analyzed using content analysis. Eighty-nine percent of participants were women with a mean ± SD age of 52.0 ± 11.6 years and a mean ± SD disease duration of 13.7 ± 14.5 years, and more than 70% had a college degree. Significant improvements were observed for self-efficacy on the PROMIS Self-Efficacy for Managing Symptoms (P = 0.002) and SEPESCA (P = 0.016) immediately post intervention, which continued to significantly improve up to the three-month follow-up (P = 0.006 and 0.035, respectively). Significant improvements were also observed for the m-FIS between baseline and the three-month follow-up (P = 0.029). Participants reported a deeper understanding of fatigue and that they liked sharing strategies and experiences with each other along with the facilitator, citing that "there was a power in our group because we had a common condition." FAME-iSS resulted in improvements in the impact of fatigue and self-efficacy for managing symptoms and performing energy conservation strategies. Feedback was positive, and the virtual format allowed for greater accessibility and sharing of strategies.

Long-Term Functional Outcome in Patients With Isolated Thalamic Stroke: The KOSCO Study.

Information on the long-term prognosis in patients with isolated thalamic stroke is sparse. We report the functional outcomes of patients with thalamic stroke up to 24 months from the KOSCO (Korean Stroke Cohort for Functioning and Rehabilitation) study. Isolated thalamic stroke was defined as the presence of lesions solely in the thalamus, excluding cases with lesions in other brain parenchyma areas apart from the thalamus, as identified by brain magnetic resonance imaging or computed tomography scans. The Fugl-Meyer Assessment, the Functional Ambulatory Category, the Korean Mini-Mental State Examination, the American Speech-Language-Hearing Association National Outcome Measurement System Swallowing Scale, and the short version of the Korean Frenchay Aphasia Screening Test were used to assess physical impairment. The Functional Independence Measure and modified Rankin Scale were used to assess functional outcomes. All measurements were conducted up to 24 months poststroke. A total of 297 patients were included, consisting of 235 with ischemic and 62 with hemorrhagic stroke. Except for the Functional Ambulatory Category and Functional Independence Measure, all physical impairments showed significant improvement up to 3 months poststroke (P<0.001) and reached a plateau. The Functional Ambulatory Category and Functional Independence Measure scores continued to improve up to 12 months poststroke (P<0.05) and reached a plateau. At 7 days poststroke, 47.5% of patients had no disability (modified Rankin Scale score<2), whereas at 24 months poststroke, 76.4% of patients had no significant disability. Patients showed rapid recovery from physical impairment up to 3 months poststroke, with additional improvements in ambulatory function and independence observed up to 12 months poststroke. Additionally, relatively favorable long-term functional prognosis at 24 months after onset was demonstrated. These results could provide insights into the proper management regarding functional outcomes of patients with isolated thalamic stroke.