Global Rating of Change for Better or Worse-What Does It Mean When Patients Who Are Treated for Patellofemoral Pain Rate Their Change?

OBJECTIVE: To investigate how a global rating of change (GROC) score corresponds to change in Knee injury and Osteoarthritis Outcome Score (KOOS) subscales in people with patellofemoral pain (PFP). DESIGN: Secondary analysis of data from 3 clinical trials. METHODS: Four hundred ninety adolescents (10-18 years old) and adults (19-40 years old) with PFP completed KOOS (5 subscales, 0-100) at baseline and 3-month follow-up as well as GROC at 3-month follow-up. GROC category descriptors were mapped to 5 categories: worse, no change, a bit better, better, and much better. Gaussian approximation was then used to calculate the change in KOOS scores for each GROC category. RESULTS: Due to overlap between KOOS scores in "no change" and "a bit better," all analyses were performed on 4 categories. For all KOOS subscales, patients who reported being "worse" had negative KOOS scale change scores (≤ -2); patients reporting "no change" had KOOS scale change scores that ranged from -5 to 14; and patients feeling "better" or "much better" had positive KOOS scale change scores that ranged from 4 to 26 and ≥16, respectively. CONCLUSION: When patients with PFP reported feeling "worse," "better," or "much better," there was a small-to-substantial change across the different KOOS scales. This is in contrast to no difference between reporting "a bit better" or "no change" in KOOS. When patients say they feel a little better, clinicians should be less confident about whether change has truly occurred. J Orthop Sports Phys Ther 2024;54(10):657-671. Epub 25 July 2024. doi:10.2519/jospt.2024.12120.

Barriers and Facilitators of Using Standardized Outcome Measures in Stroke Rehabilitation in Saudi Arabia: A Cross-Sectional Study of Practice Among Neurophysiotherapists.

Background: Clinical guidelines emphasize the use of standardized outcome measures (SOMs) in post-stroke rehabilitation. However, the extent of SOM utilization among physiotherapists in this context in Saudi Arabia remains unclear. Aim: 1) assess the current use of SOMs by physiotherapists involved in stroke rehabilitation in Saudi Arabia and 2) identify facilitators and barriers influencing the use of SOMs. Methods: An online survey was administered using a three-section questionnaire designed for this study. The first section collected demographic data, the second evaluated the use of SOMs recommended by the American Physical Therapy Association, and the third explored factors facilitating or hindering SOM use in clinical practice. Only highly recommended outcome measures capturing the three levels of the International Classification of Functioning, and Disability (ICF) model were considered: body structure and function, activities, and participation. Poisson regression analysis was used to investigate the association between SOMs utilization and educational level, work experience, type of work facility, and the number of patients treated per week. Results: A total of 138 physiotherapists responded. Most participants (98.5%) used at least one outcome measure in clinical practice. Regression analysis showed that number of strokes treated per week and facility type were associated with the likelihood of using higher number of SOMs. Physiotherapists managing more than 10 stroke patients per week and working in private sector had significantly higher odds of using a greater number of SOMs. The most pronounced barriers were time restrictions and limited resources. Conclusion: Physiotherapists working with stroke patients in Saudi Arabia demonstrate a high awareness and positive attitude toward SOM utilization. Addressing barriers such as time management and resource allocation is crucial to enhancing SOM integration in clinical practice. Clinical Rehabilitation Impact: Organizational support in terms of adequate time and resources is needed to enhance the use of SOMs among physiotherapists.

Breast-cancer specific comprehensive archive of Patient-Reported Outcome Measures (PROMs) for clinical research and clinical practice in oncology: Results from the PRO4All project.

BACKGROUND: Inclusion of patient-reported outcomes (PROs) in oncology clinical trials is strongly recommended. However, selecting the most appropriate patient-reported outcome measures (PROMs) is not easy. This study aimed to develop a breast cancer (BC) specific comprehensive archive of PROMs. METHODS: As part of the PRO4All project, we identified available PROMs in oncology by searching facit.org, eortc.org, eprovide.mapi-trust.org, PubMed, ema.europa.eu (European Public Assessment Reports) and published reviews. For this analysis, only BC tools were extracted. We described information about PROM name, type of questionnaire, questionnaire variant(s), recall period, number of items, and presence of minimum clinically important difference (MCID) reference in literature. Then, we assigned each item to a specific domain according to a predefined taxonomy of 38 items for outcome classification. RESULTS: We identified and analyzed 383 PROMs. Of these, 29 were BC specific, but 2 were excluded because the questionnaires description was not available. 6 (22.2 %) were variants of another questionnaire. All questionnaires were self-reported. In 6 cases (22.2 %) the recall period to consider was the "last week". The mean number of items per questionnaire was 25.81 (range 6-71). 602 items were assigned to an outcome domain: emotional functioning/wellbeing in 26.6 % of cases, physical functioning in 14.1 %, delivery of care in 10.8 %, and general outcomes in 10.5 %. MCID reference was found only in 4 (14.8 %) cases. CONCLUSIONS: The newly developed archive represents a useful tool to optimize the use of PROMs in the evaluation of treatments in BC patients, promoting a patient-centered approach both in clinical research and practice.

Textbook oncologic outcome is an easy-to-use composite quality measure that is strongly associated with survival in advanced-stage ovarian cancer.

OBJECTIVE: Textbook oncologic outcome (TOO) has been validated in surgical oncology as a composite quality measure correlated with oncologic outcomes. We aimed to assess the association between TOO and overall survival (OS) in patients undergoing primary treatment for advanced epithelial tubo-ovarian cancer (AEOC). METHODS: Patients undergoing surgery for AEOC between 2008 and 2019 were identified in the National Cancer Database (NCDB). Primary debulking surgery (PDS) and interval debulking surgery (IDS) cohorts were analyzed separately. TOO was defined as achieving complete debulking, length of hospital stay <10 days, no 30-day readmission, no death within 90 days, and initiation of adjuvant chemotherapy within 42 days. The Kaplan-Meier method was used to estimate 5-year OS by TOO status and Cox regression to evaluate the relationship between TOO and death within 5 years. RESULTS: A total of 21,657 patients were included: 51.4% in the PDS cohort and 48.6% in the IDS cohort. TOO was achieved (TOO+) in 20.5% of the PDS cohort and 39.2% of the IDS cohort. For the PDS cohort, achieving TOO was associated with improved 5-year OS: 59.0% TOO+ vs. 39.5% TOO- (HR 0.53, 95% CI 0.49-0.57). For the IDS cohort, a similar benefit was seen for 5-year OS: 43.9% TOO+ vs. 31.2% TOO- (HR 0.67, 95% CI 0.63-0.70). Multivariable analysis demonstrated that patients achieving TOO were at lower risk of death within 5 years in both the PDS cohort (HR 0.58, 95% CI 0.54-0.62) and the IDS cohort (HR 0.69, 95% CI 0.65-0.73). CONCLUSIONS: The TOO composite measure is associated with improved long-term survival and could be a useful quality assessment tool for patients undergoing primary treatment for AEOC, irrespective of surgical timing. This tool reflects the ability to deliver risk-based individualized decision-making using a multidisciplinary approach.

A 7-item Tampa Scale for Kinesiophobia in people with femoroacetabular impingement syndrome: evaluation of structural validity, hypothesis testing, internal consistency and minimally important change.

BACKGROUND: The 17-item Tampa Scale for Kinesiophobia (TSK) is a commonly used patient-reported outcome measure (PROM) to assess kinesiophobia, but the measurement properties of the TSK in people with femoroacetabular impingement syndrome (FAIS) are unknown. OBJECTIVES: 1) Revise the existing TSK by removing items, as needed, with inadequate functioning to optimise the TSK for people with FAIS, and 2) evaluate construct validity (both structural validity and hypothesis testing), internal consistency, and minimal important change. METHODS: Cross-sectional cohort study including 153 young adults with FAIS. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were used to evaluate structural validity and the TSK was revised to remove items with poor function, improving CFA model fit. Hypothesis testing, internal consistency (Cronbach's α) and minimal important change (distribution-based method) were also evaluated. RESULTS: A 7-item version of the TSK provided the best CFA model fit with 10-items functioning poorly and needing to be removed. The 7-item TSK was uni-dimensional (single factor in EFA) and had adequate structural validity (Standardised Root Measure Square = 0.0771). The 7-item TSK had insufficient hypothesis testing with moderate correlations to 8/14 PROMs measuring different constructs. The 7-item TSK had adequate internal consistency (α = 0.783). The minimal important change of the 7-item TSK was 6.00 points (0-100 point scale). CONCLUSION: We found that the '7-item TSK for FAIS', had superior structural validity to the original 17-item scale, suggesting that it may be more appropriate for use in this population. Further studies should evaluate other measurement properties of the 7-item scale.

Reliability and construct validity of three self-report questionnaires assessing dual-task difficulties in people with multiple sclerosis: an international study.

OBJECTIVE: To evaluate the reliability and validity of the Dual-Tasking Questionnaire (DTQ), Dual-Task Screening-List (DTSL), and Dual-Task-Impact on Daily-life Activities Questionnaire (DIDA-Q). DESIGN: Multi-center, cross-sectional study SETTING: PwMS were recruited from seven MS centers across six countries (Belgium, Chile, Italy, Israel, Spain, and Turkey). PARTICIPANTS: A total of 356 pwMS (mean age 47.5±11.5, EDSS 3.79±1.83) were enrolled. INTERVENTIONS: Not applicable MAIN OUTCOME MEASURES: The reliability (internal consistency, test-retest, and measurement error) and construct validity (structural and convergent) were assessed. RESULTS: The DTQ, DTSL, and DIDA-Q demonstrated excellent test-retest reliability [Intraclass correlation coefficients (95% CI): 0.84 (0.80-0.87) to 0.90 (0.87-0.92)] and internal consistency (Cronbach's α: 0.86 to 0.96). As hypothesized, the three questionnaires showed a strong correlation with each other, moderate-to-strong correlations with other self-report questionnaires (perceived walking difficulties, fatigue, and fear of falling), and low-to-moderate correlations with cognitive information processing speed, manual dexterity, and dual-task walking performance (walking with word list generation task), showing convergent validity. The DIDA-Q exhibited systematically superior properties. These results were also verified in subsets from six different countries. In the structural validity analysis, all questionnaires displayed two main factors, allocated as 'motor-driven' and 'cognitive-driven' subscales. CONCLUSIONS: The DTQ, DTSL, and DIDA-Q have good-to-excellent measurement properties, with the highest properties observed in DIDA-Q. The use of these self-reported questionnaires can be used in research and clinical practice to assess the impact of dual-task difficulties on the daily life of ambulatory pwMS.

Middle-range scores from the patient determined disease steps scale reflect varying levels of walking dysfunction in multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is a leading cause of neurological disability among young and middle-aged adults worldwide, and disability is measured using a variety of approaches, including patient reported outcome measures (PROMs) such as the Patient Determined Disease Steps (PDDS) scale. There is limited evidence for the validity of inferences from the middle-range of scores on the PDDS (i.e., 3 "gait disability" - 6 "bilateral support"), but that range of scores seemingly represents moderate disability characterized by varying levels of walking dysfunction. PURPOSE: The current study examined whether the middle-range of scores from the PDDS reflect varying levels of walking dysfunction among people with MS. METHOD: Participants (N = 374) completed the Patient Determined Disease Steps (PDDS) scale, Multiple Sclerosis Walking Scale-12 (MSWS-12), timed 25-foot walk (T25FW), six-minute walk (6 MW), Modified Fatigue Impact Scale (MFIS), and Multiple Sclerosis Impact Scale-29 (MSIS-29), and underwent a neurological exam for generating an Expanded Disability Status Scale (EDSS) score as part of screening and baseline data collection for a clinical trial of exercise training in MS. We undertook a series of linear trend analyses that examined differences in the outcomes of EDSS, T25FW, 6 MW, MSWS-12, MFIS subscales, and MSIS-29 subscales across the 4 levels of PDDS scores (i.e., 3-6). RESULTS: There were statistically significant and strong linear trends for EDSS (F1,370 = 306.1, p < .0001, η2 = 0.48), T25FW (F1,370 = 161.0, p < .0001, η2 = 0.32), 6 MW (F1,370 = 178.9, p < .0001, η2 = 0.34), and MSWS-12 (F1,370 = 97.0, p < .0001, η2 = 0.24). There was a strong correlation between PDDS and EDSS scores (rs = 0.695, 95% CI = 0.643, 0.748). Both PDDS and EDSS scores had strong correlations with walking outcomes, yet weaker correlations with measures of fatigue and QOL. CONCLUSION: The PDDS could serve as a simple, inexpensive, and rapidly administered PROM for remote screening and early detection of walking dysfunction for initial eligibility into clinical trials and practice for managing mobility-specific disability in MS. REGISTRATION: The study was registered on ClinicalTrials.gov on March 19, 2018 (NCT03468868).

Comparative responsiveness of the PROMIS-29 and SF-36 instruments in individuals with chronic musculoskeletal pain.

BACKGROUND: Chronic musculoskeletal pain (CMP) impacts Health-Related Quality of Life (HRQoL). Several questionnaires are widely used for evaluating the HRQoL, such as Patient Reported Outcomes Measurement Information System 29-item Health Profile (PROMIS-29) and 36-Item Short Form Health Survey (SF-36). This study aimed to assess and compare the responsiveness of PROMIS-29 and SF-36 in individuals with CMP. METHODS: The prospective study collected data from 215 patients with CMP. The participants completed both questionnaires at baseline and a 4-week follow-up with the global perceived effect (GPE) scale. The internal and external responsiveness methods evaluated the responsiveness of the instruments. The effect size (ES) and standardized response mean (SRM) assessed the internal responsiveness. External responsiveness was measured by Spearman's correlation coefficients (r) and area under the receiver operating curve (AUC). The responsiveness of the PROMIS-29 and SF-36 were compared in similar constructs. RESULTS: The PROMIS-29 demonstrated responsiveness as moderate in fatigue (ES = -0.79, SRM = -0.64), moderate to large in pain interference (ES = -0.94, SRM = -0.64), and large effect in pain intensity subscale (ES = -1.25, SRM = -1.16). The SF-36 bodily pain exhibited moderate responsiveness (ES = 0.73, SRM = 0.60). Spearman's correlation showed moderate between GPE and change scores of PROMIS-29 physical function (r = 0.31), fatigue (r = -0.36), pain intensity (r = 0.45), and weak between GPE and changes score of SF-36 (r = 0.15-0.26). Besides, the AUC of the PROMIS-29 fatigue, and pain intensity scale were 0.701 and 0.725, respectively, indicating superior discriminative ability. CONCLUSIONS: The PROMIS-29 and SF-36 were the most responsive in assessing the pain domain for physical health and PROMIS-29 fatigue domain for mental health among individuals with CMP. The PROMIS-29 demonstrated superior results compared to the SF-36. Other domains related to HRQoL could be considered in other assessment instruments.

Influence of nationality on the trajectories of pain, disability and health related quality of life in neck and back patients - The Norwegian Neck and Back Registry.

PURPOSE: The aim of the current study was to examine differences in trajectories of pain, disability, and health related quality of life (HRQOL) between non-Norwegian and Norwegian patients with neck and back pain over 12 months. METHODS: The study is based on data from the Norwegian Neck and Back Registry (NNRR). The data include demographics and patient-reported outcome measures such as pain rating, the Oswestry Disability Index and HRQOL. Data were collected at baseline, 6 and 12 months after consultation for neck and back pain in specialist health care. RESULTS: A total of 5012 patients were included. We found a significant main effect of nationality. Non-Norwegian patients showed higher levels of pain and disability and lower HRQOL than Norwegian patients. Both patient groups exhibited an improvement in all three outcomes at 6- and 12-month follow-ups. The improvement was similar for pain with the greatest improvement taking place during the first 6 months and then slightly flattening out. For disability and HRQOL, we observed a differential effect over time as a function of nationality. Both groups reported an improvement the first 6 months, however, while the Norwegian patients continued their improvement to 12 months, non-Norwegian patients had increasing disability and lower HRQOL at 12 months. CONCLUSION: Both patient groups improved over the 12-month period. Non-Norwegian patients showed an overall higher level of pain, disability and lower HRQOL compared to Norwegian patients, with a differential effect over time as a function of nationality for disability and HRQOL. Suggesting that future studies should focus on potential systemic barriers that may affect the recovery of neck and back patients based on nationality.

Development and validation of the Child Hemophilia Treatment Experience Measure: A new observer-reported outcome measure.

INTRODUCTION: The Child Hemophilia Treatment Experience Measure (Child Hemo-TEM) was developed to capture the treatment burden experience of children with haemophilia (CwH). AIM: Describe the development of this novel haemophilia-specific measure. METHODS: Interviews were conducted with clinical experts, CwH and CwH's caregivers. Interviews were analysed according to adapted grounded theory principles. Based on the analysis, a preliminary measure was developed and debriefed. Psychometric analyses were performed according to an a priori analysis plan using data collected in a cross-sectional web survey and a final measure was generated. RESULTS: Interviews with four clinical experts, 25 CwH ages 8 to <12 years, and 25 caregivers of CwH <12 years were conducted. Concepts endorsed by ≥10% of CwH and caregivers were: adherence, ease of use, emotional impacts, physical impacts, treatment concerns, and interference with daily life. Cognitive debriefing assessments were conducted to ensure participant understanding and item relevance. Caregivers found the measure to be understandable, comprehensive, and relevant. However, several issues with CwH completing the measure were identified and it was decided to only develop an observer-reported outcome version. Data for psychometric validation was collected in a web survey (N = 187). Item reduction dropped 12 items. Factor analysis generated a single, 7-item, internally consistent (α = .855) factor, which consisted of items covering all relevant a priori concepts. The majority of a priori convergent and all known groups validity hypotheses were confirmed. CONCLUSIONS: The study findings provide evidence that the Child Hemo-TEM is a brief, well-designed, and valid and reliable measure of haemophilia treatment burden.

Postoperative pain after parotid surgery-comparison between superficial/total parotidectomy and extracapsular dissection: a prospective observational study.

PURPOSE: To evaluate postoperative pain and discomfort after parotid surgery with regard to different surgical approaches. METHODS: This clinical study was carried out at a single tertiary referral center (2021-2022) and included 2 groups of adult patients (mean age 56.6 ± 12.7 vs. 53.4 ± 14.1 years) following elective parotid surgery due to a parotid tumor of any entity. The first group (SP/TP group) consisted of 31 patients after superficial parotidectomy (SP) or total parotidectomy (TP) (n = 31). The second group (ECD group) included all patients who had undergone extracapsular dissection (ECD) (n = 51). Primary endpoints comprised pain on ambulation as well as maximum and minimum pain (NRS 0-10) on the first three postoperative days (PODs). A neuropathic pain component (evaluated on POD 1 and 3), the analgesic score (collected from the patient file on POD 1-3), treatment-related side-effects/pain-associated impairments, and patient satisfaction (all measured on the 1st POD) were defined as secondary endpoints. Patients were surveyed using the standardized and validated "Quality Improvement in Postoperative Pain Treatment" (QUIPS) questionnaire and the painDETECT® questionnaire. Comparisons were performed using independent t tests, Wilcoxon tests, and χ2 tests, and the respective effect sizes were calculated. RESULTS: Looking at the first postoperative day, patients of both groups (SP/TP vs. ECD) reported comparable pain on ambulation (2.8 ± 2.0 vs. 2.6 ± 1.8; p = 0.628, r = 0.063), maximum (3.5 ± 2.2 vs. 3.5 ± 2.3; p = 0.992, r = 0.002) and minimum pain (1.1 ± 1.04 vs. 1.0 ± 1.2; p = 0.206, r = 0.157). Furthermore, there were no significant differences in pain-related restrictions or pain medication requirement. The patients in both groups were equally satisfied with their pain therapy (p = 0.282, R = 0.135). The sum score of the painDETECT® questionnaire delivered clearly negative (< 12) results on average (POD1: 6.81; POD3: 6.59); no significant difference between the groups was found (p = 0.991, R2 < .001). CONCLUSION: Neither surgical technique on the parotid gland was significantly superior to the other in terms of postoperative pain perception. Overall, postoperative pain can be classified as mild to moderate following parotid surgery. A neuropathic pain component could be excluded for the acute postoperative phase. TRIAL REGISTRATION: The study was registered in the German Registry for Clinical Studies (DRKS) (application No.: DRKS00016520).

Development and Content Validation of the Patient's Qualitative Assessment of Treatment - Real-World (PQAT-RW): An Instrument to Evaluate Benefits and Disadvantages of Treatments in Real-World Settings.

Purpose: Quantifying patient-perceived benefits and disadvantages of treatments in a real-world setting is increasingly important in healthcare decision-making. The Patient's Qualitative Assessment of Treatment (PQAT) assesses patient-perceived benefits and disadvantages of treatment, and associated trade-offs potentially influencing patients' willingness to continue treatment. It has then been modified to capture patients' perceived magnitude of benefits and disadvantages of treatment quantitatively, as well as qualitatively (PQATv2). However, the PQAT and the PQATv2 were designed for use and validated in a clinical trial setting. The objective of this study was to adapt and test the content validity of a version of the PQATv2 for use in real-world settings (PQAT-RW). Patients and Methods: The PQATv2 was adapted for use in real-world settings (PQAT-RW), and its content was validated in 16 patients with varied chronic medical conditions and medication regimens via semi-structured qualitative interviews. Results: All participants reported that the PQAT-RW was "easy to understand". The majority (n = 11/16) reported that the items covered all important aspects of their treatment experience, and that no items needed to be removed or added to the instrument. Analysis of free-text responses identified eight global concepts considered by participants when evaluating the benefits and disadvantages of treatment: treatment effectiveness, side effects and method of administration were most frequently considered (as both benefits and disadvantages), followed by frequency of administration, financial considerations, storage, packaging and drug preparation. Conclusion: The results of this study support the content validity of the PQAT-RW. They also demonstrate that using qualitative responses to contextualize quantitative responses provides unique insight into diverse and individualized patient-perceived benefits and disadvantages, and their relative importance, in real-world settings.

Differences of TF-CBT treatment effects using various outcome measures: a meta-analysis.

Background: Diagnostic criteria of posttraumatic stress disorder in children and adolescents and corresponding instruments have undergone significant changes over time. However, the impact of different outcome measures on treatment effects in the context of posttraumatic stress symptoms (PTSS) has not yet been explored.Objective: TF-CBT is a well-researched first-line treatment for PTSS among children and adolescents and thus, an ideal candidate to examine the potential influence of different outcome measures by meta-analysis.Method: A comprehensive literature search was conducted in December 2023 using seven databases. Studies included RCTs as well as non-controlled studies examining the effects of TF-CBT on pediatric PTSS. We extracted treatment effects and investigated whether there were systematic differences in the effects based on the outcome measures and their underlying DSM version.Results: In total, 76 studies (35 RCTS) met the eligibility criteria. Hedges g effect sizes with 95% confidence intervals (CI) were computed and high-risk of bias studies were excluded. No significant difference was observed between DSM-IV and DSM-5 based instruments. Individual outcome measures were found to be comparable overall, with some appearing somewhat more sensitive to change. Although a small but significant difference in true effect sizes for individual outcome measures was found, this only concerned the UCLA PTSD (g = 1.06) and the CPSS (g = 1.61) with the effect most likely being due to chance or confounding variables. TF-CBT showed large effect sizes on PTSS in within-study comparison (g = 1.32) and medium between-studies effect sizes (g = .57).Conclusions: While we could not establish equivalence, there seems to be no difference regarding the measurement of treatment effects based on outcome measure and underlying DSM version. The updated TF-CBT effect size confirmed it as an effective treatment for PTSS and secondary outcomes in children and adolescents.

No difference between outcome measures for posttraumatic stress symptoms in children and adolescents and their underlying DSM-criteria could be established.TF-CBT has again been confirmed TF-CBT as a treatment of first choice for PTSS in children and adolescents.

Translation, Cross-Culture Adaptation and Measurement Properties of the Simplified Chinese Version of the Osteoarthritis Knowledge Scale.

OBJECTIVE: The aim of this study was to culturally adapt the Osteoarthritis Knowledge Scale (OAKS) into a simplified Chinese version and to evaluate its measurement properties among Chinese-speaking populations. METHODS: The OAKS scale was translated and cross-culturally adapted following COSMIN guidelines. A total of 368 participants were recruited, including individuals with knee or hip osteoarthritis (OA), healthcare professionals, and individuals without OA. The study evaluated the scale's internal consistency, test-retest reliability, and factor structure using Exploratory Factor Analysis (EFA). RESULTS: The translated OAKS scale demonstrated acceptable levels of reliability across different groups. Cronbach's alpha for the KOAKS was 0.70 overall, with subgroup values ranging from 0.70 to 0.71. For the HOAKS, Cronbach's alpha was 0.77 overall, with subgroup values ranging from 0.63 to 0.72. Test-retest reliability showed high Intraclass Correlation Coefficient (ICC) values for both scales (KOAKS: ICC = 0.960; HOAKS: ICC = 0.982). EFA revealed that the overall OAKS explained a substantial portion of the variance (60.51%), with KOAKS accounting for 59.35% and HOAKS accounting for 54.68% of the variance. CONCLUSION: The simplified Chinese version of the OAKS is a reliable tool for assessing OA knowledge among Chinese-speaking patients, healthcare professionals, and the general public. The findings highlight the necessity for continuous improvement and adaptation of educational interventions to address specific knowledge gaps within the Chinese context.

The Influence of Kinesiophobia and Pain Catastrophizing on Disease-Specific Quality of Life in Patients With Recurrent Patellofemoral Instability.

BACKGROUND: The Banff Patellofemoral Instability Instrument 2.0 (BPII 2.0) is a disease-specific, quality of life patient-reported outcome measure (PROM) that is valid and reliable in patients with recurrent lateral patellofemoral instability (LPI). Quality of life encompasses the physical, emotional, and psychological aspects of patient functioning and recovery. PURPOSES: To concurrently validate the BPII 2.0 to the Tampa Scale for Kinesiophobia (TSK-11), the Pain Catastrophizing Scale (PCS), and the Anterior Cruciate Ligament-Return to Sport after Injury Scale (ACL-RSI) in patients presenting with recurrent LPI and to assess baseline values for the PROMs in patients with LPI. STUDY DESIGN: Cohort study (Diagnosis); Level of evidence, 2. METHODS: A total of 107 consecutive patients with recurrent LPI were assessed between January and October 2021. Patients completed the BPII 2.0, TSK-11, PCS, and ACL-RSI. A Pearson r correlation coefficient was employed to examine relationships between the PROMs. Baseline values, as well as floor and ceiling effects and Cronbach alpha, were assessed for all PROMs. RESULTS: All 107 patients completed the 4 PROMs. Patients included 28 men (26.2%) and 79 women (73.8%), with a mean (SD) age of 25.7 (9.8) years. The mean (SD) age at first dislocation was 14.8 (6.3) years. The TSK-11, PCS, and ACL-RSI were all statistically significantly correlated with the BPII 2.0 (P < .01; 2-tailed), with moderate correlations (r = -0.361-0.628) The R2 values indicated an overlap of the constructs measured by the PROMs. CONCLUSION: A statistically significant correlation was evident between the BPII 2.0 and the other PROMs. The BPII 2.0 does not explicitly measure kinesiophobia or pain catastrophizing; however, the significant statistical relationship of the TSK-11 and PCS to the BPII 2.0 suggests that this information is being captured and reflected.

Evidence-based hierarchy of pain outcome measures for osteoarthritis clinical trials and meta-analyses.

OBJECTIVE: To rank commonly used patient-reported outcome measures (PROMs) for assessing pain in osteoarthritis trials according to their assay sensitivity, defined as the ability of a PROM to distinguish an effective from a less effective intervention or placebo, proposing a hierarchy for PROM selection in trials and data-extraction in meta-analyses. DESIGN: Analysis of trials with placebo, sham, or non-intervention control that included ≥100 patients per arm with knee/hip osteoarthritis, reporting treatment effects on ≥2 pain PROMs. Treatment effects from all PROMs were standardized on a 0-100 scale. Negative mean differences indicated a larger effect of the experimental treatment compared to control. We ranked PROMs by assay sensitivity using a Bayesian multi-outcome synthesis random-effects model. RESULTS: 135 trials comprising 57,141 participants were included. The ranking of PROMs from highest to lowest assay sensitivity was as follows: pain overall, pain on stairs, pain at night, pain on walking, pain at rest, WOMAC pain, WOMAC global, Lequesne index. Pain overall, the highest-ranked PROM, had a pooled mean difference of -6.96 (95%CrI -7.94, -6.02), while WOMAC pain, the most reported PROM in our study, had a pooled mean difference of -4.90 (95%CrI -5.55, -4.26). The pooled ratio of mean differences between pain overall and WOMAC pain was 1.42 (95%CrI 1.30, 1.55), representing a 42% larger effect size with pain overall. CONCLUSIONS: Pain overall has better assay sensitivity than other pain PROMs. Investigators should consider the hierarchy proposed in this study to guide PROM selection in osteoarthritis clinical trials and data extraction in osteoarthritis meta-analyses.

Development of Symptom Specific Dysphagia Quality of Life Questionnaire in Tamil.

BACKGROUND: Swallowing intricately involves sensorimotor systems, pivotal for integrating upper digestive and respiratory functions. Dysphagia, challenging swallowing, often precipitates anxiety and depression, deeply affecting the quality of life (QOL). Understanding patient-centric symptoms is vital for assessing dysphagia's QOL impact. AIM: This study aimed at developing and validating the Symptom Specific Dysphagia Quality of Life Questionnaire in Tamil (SSDQOL-T). METHOD: SSDQOL-T was developed in Tamil and underwent rigorous content validation. This questionnaire was administered to 120 normal individuals and 32 dysphagia patients, assessing various swallowing difficulties and their QOL impact. RESULTS: Results indicate SSDQOL-T's good internal consistency (Cronbach's α = 0.78). Significant differences in swallowing ability and QOL were noted across age groups, with older adults experiencing heightened symptoms. A high significance in mean score was obtained between healthy adults and dysphagia across all sub-domains with a 'p-value' of 0.0005. Symptoms that were found to have high significance were cough/gag reflex, regurgitation, odynophagia, globus sensation, heartburn and tiredness when compared between mechanical and degenerative dysphagia group. Strong correlations were found between SSDQOL-T scores and the Dysphagia Handicap Index in Tamil (r = 0.89). CONCLUSION: The SSDQOL-T questionnaire provides a robust tool for evaluating dysphagia-related QOL in the Tamil-speaking population. Its validation underscores its clinical relevance and utility for understanding the multidimensional impact of dysphagia. This study emphasizes the importance of culturally sensitive assessment tools in comprehensively evaluating dysphagia's QOL implications.

Twenty-five years of experience with patient-reported outcome measures in soft-tissue sarcoma patients: a systematic review.

PURPOSE: As the importance of the patient's perspective on treatment outcome is becoming increasingly clear, the availability of patient-reported outcome measures (PROMs) has grown accordingly. There remains insufficient information regarding the quality of PROMs in patients with soft-tissue sarcomas (STSs). The objectives of this systematic review were (1) to identify all PROMs used in STS patients and (2) to critically appraise the methodological quality of these PROMs. METHODS: Literature searches were performed in MEDLINE and Embase on April 22, 2024. PROMs were identified by including all studies that evaluate (an aspect of) health-related quality of life in STS patients by using a PROM. Second, studies that assessed measurement properties of the PROMs utilized in STS patients were included. Quality of PROMs was evaluated by performing a COSMIN analysis. RESULTS: In 59 studies, 39 PROMs were identified, with the Toronto Extremity Salvage Score (TESS) being the most frequently utilized. Three studies evaluated methodological quality of PROMs in the STS population. Measurement properties of the TESS, Quick Disability of the Arm, Shoulder and Hand (QuickDASH) and European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) were reported. None of the PROMs utilized in the STS population can be recommended for use based on the current evidence and COSMIN analysis. CONCLUSION: To ensure collection of reliable outcomes, PROMs require methodological evaluation prior to utilization in the STS population. Research should prioritize on determining relevant content and subsequently selecting the most suitable PROM for assessment.

Systematic review of applications and properties of the NoMAD instrument for assessing implementation outcomes: Study protocol.

Background: Implementation outcomes measures can be used to assess the implementation of complex health and social care interventions, but evidence for the use of these measures, and their psychometric properties, remains limited. The NoMAD ( Normalisation Me asure Development) survey, based on Normalisation Process Theory, was developed to assess, monitor, or measure factors likely to affect normalisation of a new practice from the perspective of participants who are engaged in an implementation process. Since publication in 2015, NoMAD has been translated into several languages and is increasingly being used in health and care research. This systematic review will identify, appraise, and synthesise the existing literature on the use of NoMAD as an implementation outcome measure, focusing on use and application across different studies and settings, and on its properties as a measurement tool. Methods: We will systematically search the bibliographic databases Web of Science, Scopus and PubMed for articles reporting empirical data in peer-reviewed journals. A citation search will also be undertaken in Google Scholar for primary NoMAD publications. Studies will be eligible for inclusion if they: (a) specify using NoMAD as a method and report results from using it, and/or (b) report a translation and/or validation study of NoMAD's measurement properties. Screening of abstracts and full text articles will be done independently by two researchers. Data extraction will be structured to allow collection and descriptive synthesis of data on study characteristics, use of NoMAD, psychometric results, and authors' reflections and recommendations. Conclusions: This review will provide the first synthesis of how NoMAD has been applied in health and care research, and evidence on its properties as an outcome measure since its publication. This will be used to update existing freely accessible guidance for researchers and other users, and disseminated through peer-reviewed publications, and engagement activities with researchers and practitioners.

Background: Implementation outcome measures are survey tools that have been developed to assess the success of implementation of health and social care interventions. Using theory, the NoMAD ( Normalisation Me asure Development) survey was developed to assess implementation processes, by asking structured questions of persons who are involved in a specific implementation. Once measures like NoMAD are used enough over time, and in a range of studies of different kinds of interventions in different settings, we can collate evidence from those studies to decide (1) how useful they are, and (2) how scientifically robust they are for making assessments in research. In this review, we will search the published literature for papers that report data from studies using NoMAD and summarise their characteristics and results to provide recommendations about how useful and scientifically robust NoMAD is at this time. Methods:We will search databases (Web of Science, Scopus and PubMed), and a google search engine for published studies. We will include papers if they have used the NoMAD survey in their research and report results in their paper or have translated it into another language and tested it scientifically. Decisions about whether to include a paper will be made independently by two researchers, compared, and then agreed. A structured form will be used to capture the same information from each paper. We will summarise information on the studies, how they used NoMAD, what scientific evidence they provide about it, and what authors thought about using it. Conclusions: This will be the first review of studies using the NoMAD survey since it was published in 2015. The results will be used to update publicly available guidance for researchers and other users. We will also share our findings directly through engagement activities with researchers and practitioners and will publish them in scientific journals.

Identifying the content of the Lower Extremity Motor Activity Log based on the International Classification of Functioning, Disability and Health.

PURPOSE: To identify the content and the constructs measured in the Lower Extremity Motor Activity Log (LE-MAL) based on the International Classification of Functioning, Disability and Health (ICF) framework and to determine whether the instrument items fit within the ICF mobility domain. METHODS: Concepts and constructs measured within each scale were linked to the best-matched ICF categories and classified using established linking rules. Two independent researchers determined the initial linkages. A final consensus was reached with the other researchers. The agreement was analysed through the agreement percentage and the kappa coefficient. RESULTS: The subscales assess performance through information about need or dependency, personal and environmental factors, and appraisal of the items. Thirteen concepts were identified in LE-MAL: two concepts for the Assistance Scale are covered in the environmental factors component; 10 concepts for the Functional Performance Scale where all items are covered in the mobility domain; one concept for the confidence scale is covered in the body functions component. CONCLUSIONS: The general construct of LE-MAL assessed is performance in the ICF mobility domain and provides additional information about the mental function, environmental factors, independence, appraisal, and personal factors. The study highlighted the conceptual connection between the LE-MAL and the ICF framework.

The use of the lower extremities influences the quality and independence of gait in neurological populations.No studies have analysed the Lower Extremity Motor Activity Log (LE-MAL) content with a theoretical framework.Theoretical framework linkage complements the content validity of the LE-MAL.Linking with the International Classification of Functioning, Disability and Health (ICF) aids clinics in report writing and treatment planning.