Global Rating Of Change Scale Research Articles

Translation, cross-cultural adaptation, and psychometric properties of the Arabic version of the MedRisk instrument for measuring patient satisfaction with physical therapy care

Purpose This study aimed to translate, cross-culturally adapt, and validate the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care into Arabic (MRPS-Ar). Materials and Methods The 20-Item MRPS was translated and cross-culturally adapted into Arabic following international guidelines. Patients (n = 229) with musculoskeletal conditions who received physical therapy care completed the MRPS-Ar and global rating of change scale. Of these patients, 95 completed the MRPS-Ar twice. Factor structure, floor and ceiling effects, internal consistency, test-retest reliability, and construct validity of the MRPS-Ar were evaluated. Results Principal component analysis suggested 3-factor solution: a 7-item facility experience, 6-item therapeutic experience, and 3-item positive experience. The MRPS-Ar and its factors showed acceptable internal consistency (Cronbach’s alpha coefficients ranged from 0.819 to 0.936) and excellent test-retest reliability (ICCs ranged from 0.965 to 0.983). The global measures of satisfaction were significantly correlated with the global rating of change (Spearman’s rho = −0.678, p < 0.001 for item “overall satisfaction” and Spearman’s rho = −0.690, p < 0.001 for item “would return”). Conclusions The 18-item MRPS-Ar displayed adequate psychometric properties for measuring patients’ satisfaction with physical therapy care. The MRPS-Ar is a reliable and valid instrument that can be used in medical, clinical, and research fields.

Open-label observational study of effectiveness and tolerability of ipidacrine in treatment of patients with diabetic polyneuropathy (DIAMANT study)

Diabetic polyneuropathy (DPN) is one of the most common complications of diabetes mellitus, leading to the development of flaccid paresis, neuropathic pain syndrome, sensitive ataxia, as well as trophic disorders in the distal parts of the lower extremities.The purpose of the randomized, open-label, comparative, prospective study was to evaluate the effectiveness and tolerability of ipidacrine in the complex treatment of patients with DPN.Materials and methods. Patients with DPN (n = 60) were randomized into 2 groups. Both groups received basic therapy (alpha-lipoic acid, B vitamins, gabapentin); in the treatment of patients of the main group (n = 30), in addition, ipidacrine was used (Ipidacrine-SZ, North Star Co., Russia). We have analyzed the intensity of pain syndrome (VAS-P), the average daily dosage of gabapentin, and the results of the neuropathic dysfunctional scale (modified version, NDSm), Pittsburgh Sleep Quality Index, PSQI), Global Rating of Change Scale (GROC), the results of electroneuromyography (ENMG). The total duration of the observation and treatment period was 2 months.Results. After 2 months of therapy in the main group of patients, compared with the control group, there was significantly more complete pain control (VAS-P: 3.0 ± 0.9 vs 3.6 ± 0.8), a decrease in the average daily dosage of gabapentin (390 vs 500 mg/day), reduction in the severity of clinical manifestations of polyneuropathic syndrome (NDSm: 4.4 ± 1.0 vs 4.9 ± 1.0 points) and improvement in sleep quality (PSQI: 6.8 ± 1.3 vs 7.9 ± 1.7). According to ENMG data, patients in the main group showed a significant improvement in the neurophysiological parameters of both motor and sensory fibers, which was significantly more pronounced compared to the control group. A significantly larger proportion of patients in the main group assessed the improvement from the therapy as ‘pronounced’ (GROC: 10/33.3 % vs 6/20.0 %).Conclusions. The use of ipidacrine in complex therapy of patients with DPN can significantly reduce the clinical manifestations of disease and improve the neurophysiological parameters of the peripheral nerves of the lower extremities. Ipidacrine can be considered as a basic drug for the treatment of patients with neurological complications of diabetes mellitus.

Minimal clinically important difference in physical activity in patients with stroke

Background Estimates of the minimal clinically important difference (MCID) for stroke-related outcomes are needed, but the MCID for physical activity is unknown. Objective To provide an anchor-based estimate of the MCID for physical activity in patients with stroke. Methods This study included 31 patients with stroke admitted to a hospital and discharged home. Physical activity, including the daily number of steps and metabolic equivalents (METs), was evaluated shortly after informed consent was obtained following admission (baseline) and discharge using an Active-style Pro HJA-750C with a triaxial accelerometer. We calculated the number of steps and time rate (%) of sedentary behavior (SB), light-intensity physical activity (LPA), and moderate-to-vigorous physical activity (MVPA) per day. After discharge, the physical therapist rated each participant’s perceived amount of physical activity recovery on the Global Rating of Change scale (GRC). The mean change in each physical activity data point from baseline to after discharge in the group of participants who answered “a little better, meaningful” in the GRC was considered the MCID. Results Eighteen participants were included in the analysis. Participants’ physical function improved from baseline to at discharge during hospitalization, although mild motor paralysis persisted. MCID values for the step activity, SB, LPA, and MVPA were 1828 steps, -11.2%, 6.9%, 4.3% per day, respectively. Conclusion For researchers and clinicians, this study’s MCIDs provide a benchmark for interpreting changes in the effects of intervention studies, and specific guidelines for interventions in clinical practice. Further research with larger sample sizes is required to confirm these findings.

Intra-articular injection of gold micro-particles with hyaluronic acid for painful knee osteoarthritis

BackgroundRecently, in an open pilot study, we found up to two years, a potential pain-relieving effect of intra-articular gold micro-particles using the patient’s synovial fluid for patients with knee osteoarthritis (KOA). During the study the excluded group of patients, due to multisite pain, co-morbidities, and other exclusion criteria., received intra-articular gold micro-particles using hyaluronic acid,. We aimed to identify if pre-treatment characteristics influence the global outcome two years after intra-articular treatment for painful KOA with gold microparticles using hyaluronic acid.MethodsUsing hyaluronic acid as the carrier, 136 patients with KOA received intraarticular injections with 20 mg gold microparticles (72.000 particles, 20–40 μm in diameter). In the analysis, we included the Global Rating of Change Scale, Pain Detect Questionnaire (PDQ), Body Mass Index (BMI), and Kellgren & Lawrence score at the inclusion, Western Ontario, and McMaster Universities Osteoarthritis Index (WOMAC) sub-scores for pain, stiffness, and function at inclusion and two years.ResultsOn the Global Rating Change Scale, 69.1% of patients reported a positive effect, 28.7% no effect, and 2.2% worse. PDQ and the three WOMAC subscores all improved at two years of follow-up. PDQ ≥ 13 (P = 0.028), BMI (P = 0.022) and Kellgren & Lawrence grade 4 (P = 0.028) at inclusion reduced the effect with a minor odds ratio compared to the baseline effect of treatment (P = 0.025). WOMAC subscores at inclusion did not influence the outcome (P > 0.5).ConclusionsSevere osteoarthritis, obesity, and neuropathic pain, reduced the effect of intra-articular gold microparticles for knee OA.Trial registrationThe study followed the principles of the Declaration of Helsinki and was approved by the local ethics committee of the North Denmark Region by 27/07/2016 (N-20,160,045). The regional data protection agency approved the project by 06/07/2016 (2008-58-0028, ID 2016 − 116) and registered in ClinicalTrial.Gov by 04/01/2018 (NCT03389906).

Oswestry Disability Index, Roland-Morris Disability Questionnaire, and Quebec Back Pain Disability Scale: Responsiveness and Minimal Clinically Important Changes in Iranian People with Lumbar Disc Herniation Following Physiotherapy.

The present study aimed to investigate the responsiveness of the Persian version of the Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ), and Quebec Back Pain Disability Scale (QBPDS) and detect minimal clinically important changes (MCICs) of these questionnaires in people with lumbar disc herniation. Ninety-two patients with lumbar herniated disc completed the Persianversion of the ODI, RMDQ, and QBPDS before and after the physiotherapy intervention. Additionally, they completed a global rating of change scale after the final physiotherapy session to give an account of non-improved and improved outcomes. The responsiveness of these three disability questionnaires was represented by Receiver Operating Characteristic (ROC) and correlation analyses. The MCIC was defined as the best cut-off when sensitivity and specificity were optimally balanced. Area under the ROC curves are in the acceptable range for ODI and QBPDS (0.78 and 0.70, respectively). Moreover, ODI, RMDQ, and QBPDS have significant positive fair to moderate correlation with the external anchor (P<0.001). The MCIC values for ODI, RMDQ, and QBPDS were 13, 5.5, and 14.5 points, respectively. Our results revealed that the ODI and QBPDS questionnaires have adequate responsiveness to detect improvements in the functional status of lumbar herniated disc patients following a physiotherapy treatment. Therefore, the ODI and QBPDS seem to be superior to the RMDQ for use in randomized clinical trials and clinical settings in patients with herniated lumbar discs. The MCIC scores of 13 and 14.5 obtained for the ODI and QBPDS can help to identify important changes in the clinical status of an individual patient and treatment efficacy.

Age-related change in gait efficacy and predictors of its decline: A 3-year longitudinal study.

This study aimed to calculate the minimal clinically important difference (MCID) for a modified Gait Efficacy Scale (mGES) over 3 years and to clarify the predictors of mGES decline. In total, 87 community-dwelling older adults were enrolled in this 3-year longitudinal study. The mGES, fall history and physical function (chair stand frequency, open-eyes one-leg stand, open-close stepping test, walking speed, walking endurance [shuttle stamina walk test] and physical activity) were assessed at baseline. After a 3-year follow-up period, the mGES and Global Rating of Change Scale were assessed. The MCID was calculated using anchor-based methods, with the Global Rating of Change Scale as an anchor. The participants were classified into the decline and keep groups based on whether the changes in the mGES were greater than the MCID. A logistic regression analysis was conducted using the mGES as the dependent variable and physical characteristics, fall history, and physical function as independent variables. The MCID for the mGES over 3 years was -7.38 points. A logistic regression analysis identified low open-close stepping (odds ratio, 0.87; 95% confidence interval, 0.782-0.985; P = 0.027) and the shuttle stamina walk test (odds ratio, 0.974; 95% confidence interval, 0.949-1.000; P = 0.049) as predictors of the mGES decline. These findings suggest that a change of 7.38 points in the mGES was clinically significant and that poor agility and walking endurance can predict future decline in the mGES. Geriatr Gerontol Int 2024; 24: 90-94.

Responsiveness and Minimal Clinically Important Difference of the Thai Version of the International Knee Documentation Committee Subjective Knee Form in Patients With Anterior Cruciate Ligament Injury.

The International Knee Documentation Committee Subjective Knee Form (IKDC-SKF) is a knee-specific patient-reported outcome (PRO) measure that is commonly used to evaluate patients with various knee disorders. The Thai version of the IKDC-SKF (Thai IKDC-SKF) was shown to have good validity and reliability; nonetheless, no data regarding its responsiveness are available. To evaluate the responsiveness of the Thai IKDC-SKF for assessing patients with anterior cruciate ligament (ACL) injury and determine the minimal clinically important difference (MCID) for this PRO measure. Cohort study (diagnosis); Level of evidence, 3. This prospective study included ACL-injured patients who were scheduled for ACL reconstruction (ACLR) at a single institution. The patients completed the Thai IKDC-SKF at the baseline and the 6-month postoperative follow-up. The global rating of change scale was an anchor question that evaluated patients' overall perception of a clinical change compared with their preoperative condition. The effect size and standardized response mean were calculated. The MCID was identified with an anchor-based approach by plotting a receiver operating characteristic curve and calculating the value that maximized the Youden index. Of 59 enrolled patients, 53 patients (89.8%) completed the preoperative and 6-month postoperative Thai IKDC-SKF. The mean (±SD) age of the participants was 32.3 ± 10.3 years, and 86.8% were men. The mean Thai IKDC-SKF score improved significantly from preoperatively to the 6-month follow-up (from 56.3 ± 14.9 to 70.8 ± 14.1, respectively; P < .001), with an effect size of 0.975 and a standardized response mean of 0.977. A receiver operating characteristic curve was generated to determine the ability of the Thai IKDC-SKF to distinguish between improved patients and unimproved patients, and the area under the curve was 0.80 (95% CI, 0.68-0.92), which was considered excellent. The MCID was 15.5, which yielded a sensitivity and specificity of 0.55 and 1, respectively. This study confirmed the responsiveness of the Thai IKDC-SKF for detecting a clinical change in ACL-injured patients after ACLR. The identified MCID of 15.5 can be used to calculate the significant clinical change and sample size in future studies.

Blood Flow Restriction Training in Nonspecific Shoulder Pain: Study Protocol of a Crossover Randomised Controlled Trial.

"Nonspecific shoulder pain" encompasses various non-traumatic musculoskeletal shoulder disorders, diverging from diagnostic terminologies that refer to precise tissue-oriented clinical diagnosis. Blood flow restriction (BFR) training, involving partial arterial inflow and complete venous outflow restriction, has exhibited acute hypoalgesic effects primarily in healthy populations by increasing their pain thresholds. This study aims to examine whether a single BFR session with low-load exercises can alleviate pain perception among nonspecific shoulder pain patients. Conducted as a single-blind crossover randomised clinical trial, 48 adults (age range: 18 to 40) presenting with nonspecific shoulder pain will partake in two trial sessions. Random assignment will place participants into BFR or sham BFR groups and ask them to perform one exercise with BFR. Subsequently, participants will complete a shoulder girdle loading regimen comprising six exercises. The second session will involve participants switching treatment groups. Pain pressure thresholds (PPTs), shoulder pain and disability via the shoulder pain and disability index (SPADI), maximal voluntary isometric contraction (MVIC) of shoulder external rotators, pain during active abduction, and peak pain during shoulder external rotation will be evaluated using the numeric pain rating scale (NPRS). Immediate post-exercise assessments will include patient-perceived pain changes using the global rating of change scale (GROC) and participant-rated perceived exertion (RPE), employing a modified Borg's scale (Borg CR10) post-BFR or sham BFR exercise session. Each session will encompass three assessment periods, and a combination of mixed-effect models and descriptive statistics will underpin the analysis. This protocol was approved by Cyprus National Bioethics Committee (ΕΕΒΚ/2023/48), and was registered in ClinicalTrials.gov (Registration number: NCT05956288). Conclusion: The anticipated outcomes of this study illuminated the acute effects of BFR training on pain perception within the context of nonspecific shoulder pain, potentially advancing strategies for managing pain intensity using BFR techniques.

Confirmatory structural validation and refinement of the Recurrent Urinary Tract Infection Symptom Scale.

To confirm the structural validity of the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), determining whether a bifactor model appropriately fits the questionnaire's structure and identifying areas for refinement. Used in conjunction with established clinical testing methods, this patient-reported outcome measure addresses the urgent need to validate the patient perspective. A clinically and demographically diverse sample of 389 people experiencing recurrent UTI across 37 countries (96.9% female biological sex, aged 18-87 years) completed the RUTISS online. A bifactor graded response model was fitted to the data, identifying potential items for deletion if they indicated significant differential item functioning (DIF) based on sociodemographic characteristics, contributed to local item dependence or demonstrated poor fit or discrimination capability. The final RUTISS comprised a 3-item symptom frequency section, a 1-item global rating of change scale and an 11-item general 'rUTI symptom and pain severity' subscale with four sub-factor domains measuring 'urinary symptoms', 'urinary presentation', 'UTI pain and discomfort' and 'bodily sensations'. The bifactor model fit indices were excellent (root mean square error of approximation [RMSEA] =0.041, comparative fit index [CFI] =0.995, standardised root mean square residual [SRMSR] =0.047), and the mean-square fit statistics indicated that all items were productive for measurement (mean square fit indices [MNSQ] =0.64 - 1.29). Eighty-one per cent of the common model variance was accounted for by the general factor and sub-factors collectively, and all factor loadings were greater than 0.30 and communalities greater than 0.60. Items indicated high discrimination capability (slope parameters >1.35). The 15-item RUTISS is a patient-generated, psychometrically robust questionnaire that dynamically assesses the patient experience of recurrent UTI symptoms and pain. This brief tool offers the unique opportunity to enhance patient-centred care by supporting shared decision-making and patient monitoring.

Comparison of the physiotherapy with and without focus on the scapulothoracic joint on pain, range of motion, functional disability, quality of life, and treatment effectiveness of patients after arthroscopic shoulder rotator cuff tendon repair: A randomized controlled trial with short-term follow-up

BackgroundRotator cuff tears are prevalent shoulder injuries, significantly affecting shoulder stabilization and patient quality of life. Despite rehabilitation efforts post-arthroscopic surgery, the efficacy of scapular-focused exercises remains uncertain with limited supportive evidence. PurposeThis study aimed to compare the immediate and short-term effects of emphasizing scapulothoracic joint rehabilitation in addition to conventional physiotherapy on pain, range of motion (ROM), function, quality of life, and treatment effectiveness in patients after shoulder arthroscopic rotator cuff tendon repair (ARCR). Study DesignTwo arms, parallel-group, randomized controlled trial, with concealed allocation MethodsThis parallel-group randomized controlled trial, with concealed allocation, was conducted in a clinic setting on 28 participants aged 30-75 years, exhibiting progressive degenerative full-thickness tears of rotator cuff muscles and undergoing ARCR, provided the tear size was small or medium. Participants were randomly allocated to receive 21 sessions of conventional rehabilitation (n = 14) or comprehensive rehabilitation (with a focus on scapula training; n = 14) in 12 weeks (reporting of intervention complied with Consensus on Exercise Reporting Template (CERT) and Template for Intervention Description and Replication (TIDieR) Guideline). Pain (as primary outcome), ROM, functional disability, quality of life, and treatment effectiveness were assessed both pre- and post-intervention, along with a 3-month follow-up. Participants, assessors, and statistician were blinded to group assignment. For the reporting of the RCT, the Consolidated Standards of Reporting Trials (CONSORT) has been used. ResultsTrial was completed with 28 participants and no dropouts. The analysis of variance revealed statistically significant group-by-time interaction (p < 0.05) for all outcome measures except for active ROMs (p > 0.05). Multiple comparison analysis showed statistically significant between-group differences (p < 0.05) at 3-month follow-up with large effect size (>0.8 Hedges’ g) for all outcomes (mean differences: visual analog scale: 1.3, American Shoulder and Elbow Surgeons: −17.3, Shoulder Pain and Disability Index: 17.6, Western Ontario Rotator Cuff: −19.5, QuickDASH: 17.8), except for extension ROM (passive ROM: confidence interval = −25.4 to 0.56; active ROM: confidence interval = −20.0 to 6.0). The differences in American Shoulder and Elbow Surgeons and Western Ontario Rotator Cuff were also clinically significant based on their minimally clinical important difference cutoff points. For the Global Rating of Change scale, more participants stated “much improved” in the comprehensive group than in the conventional. No adverse effects were reported. ConclusionsComprehensive rehabilitation, compared to conventional physiotherapy, has shown a statistically and clinically significant difference in improving pain, ROM, functional disability, quality of life, and treatment effectiveness in patients after ARCR.

Responsiveness and Minimal Important Change of the Arabic Disabilities of the Arm, Shoulder and Hand (DASH) in Patients with Upper Extremity Musculoskeletal Disorders.

The aim of this study was to examine the responsiveness of the Arabic Disabilities of the Arm, Shoulder and Hand (DASH) and to quantify its minimal important change (MIC) for improvement. People with upper extremity musculoskeletal problems who were receiving physical therapy were evaluated at baseline and again during a follow-up appointment, with a median time frame of 7 days between the two testing sessions (range of 6 to 72 days). The participants completed the Arabic DASH, Global Assessment of Function (GAF), Numeric Pain Rating Scale (NPRS) and Global Rating of Change Scale (GRC). The responsiveness of the Arabic DASH was assessed by examining the pre-specified hypotheses. The MIC for improvement was determined using the receiver operating characteristic method (MICROC) and the predictive modeling method (MICpred). As hypothesized, a change in the Arabic DASH demonstrated a significant positive correlation with changes in the GAF (r = 0.69), NPRS (r = 0.68) and GRC (r = 0.73). Consistent with our hypotheses, the DASH change scores could be used to differentiate between participants who improved and those who did not improve (area under the receiver operating characteristic curve = 0.87), and they showed a large magnitude of change (effect size = 1.53, standardized response mean = 1.42) in patients who improved. All the hypotheses specified a priori were supported by the results. The Arabic DASH MICROC and MICpred were estimated to be 14.22 and 14.85. The interaction between the DASH change and baseline score was not a significant predictor of status (improved vs. not improved) (p = 0.75), indicating that the DASH MIC was not baseline-dependent. The Arabic DASH demonstrated sufficient responsiveness, supporting the idea that the Arabic DASH is capable of detecting changes in upper extremity function over time. The value of the Arabic DASH MIC was similar when estimated using the predictive modeling and ROC methods, and the MIC was not dependent on baseline status.

Responsiveness of the Arabic Quick Disabilities of the Arm, Shoulder and Hand in Patients with Upper Extremity Musculoskeletal Disorders.

This study aimed to examine the responsiveness of the Arabic Disabilities of the Arm, Shoulder and Hand short version (Quick-DASH) in patients with upper extremity musculoskeletal disorders. Participants with upper extremity musculoskeletal disorders (N = 88) under physical therapy care were assessed at initial visit and later at a follow-up visit, and they completed the Arabic Quick-DASH, DASH, Numeric Pain Rating Scale (NPRS), Global Assessment of Function (GAF), and the Global Rating of Change Scale (GRC). Responsiveness of the Arabic Quick-DASH was assessed by examining six pre-defined hypotheses. Consistent with the pre-defined hypotheses, the Arabic Quick-DASH changes scores exhibited significant positive correlation with the change in DASH (r = 0.98), GAF (r = 0.67), NPRS (r = 0.72), and the GRC (r = 0.78). As hypothesized, the Arabic Quick-DASH showed a large effect size above the pre-determined level (ES = 1.61, SRM = 1.49) in patients who reported improved upper extremity function. The Arabic Quick-DASH change score discriminated between patients who reported improvement versus no improvement in upper extremity function (area under the receiver operating characteristic curve = 0.90). The results supported 100% (six out of six) of the pre-defined hypotheses. The Arabic Quick-DASH demonstrated sufficient responsiveness where all the pre-defined hypotheses were supported, leading to the established validity of the Arabic Quick-DASH change score as a measure of change in upper extremity function and symptoms. The minimal importance change in the Arabic Quick-DASH needs to be determined in future studies.

Feasibility of ballistic strength training to improve mobility of inpatients with traumatic brain injury

The objective of this study was to investigate the feasibility of ballistic strength training (BST) to improve the mobility of individuals recovering from traumatic brain injury (TBI) in an inpatient rehabilitation centre. Participants had a maximum of eight usual physiotherapy sessions substituted with BST sessions. The feasibility of BST was assessed in terms of recruitment, attendance, adverse events (AEs), and participant acceptability of the intervention. The clinical aspects of feasibility were assessed by recording the ability of participants to complete the exercises and acquire skills. Secondary measures included the 10-metre walk test, the 6-minute walk test, and the Global Rating of Change scale. Fourteen of 22 eligible individuals with TBI in an inpatient rehabilitation centre consented to participate in the study, of whom two were excluded. No intervention-related AEs occurred. Participants attended 97% (71/73) of the total sessions. Participants positively accepted the intervention as rated on a visual analogue scale, M (SD) = 9.2 (0.9). All participants were able to complete the BST exercises. Participants significantly improved comfortable walking speed and walking capacity (p &lt; 0.01). Participants perceived a meaningful change in walking ability. BST appears to be a promising rehabilitation method that may improve the walking outcomes of individuals with TBI in an inpatient rehabilitation setting. Larger-scale clinical trials are warranted.

Initial effect of high-volume mobilisation with movement on shoulder range of motion and pain in patients with rotator cuff-related shoulder pain: protocol for a randomised controlled trial (Evolution Trial)

IntroductionMobilisation with movement (MWM) is commonly used for treating patients with rotator cuff-related shoulder pain (RCRSP). However, the evidence supporting MWM efficacy for improving shoulder range of motion (ROM) and...

Sensitivity to Change and Responsiveness of the Upper Extremity Fugl-Meyer Assessment in Individuals With Moderate to Severe Acute Stroke.

The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a widely used outcome measure for quantifying motor impairment in stroke recovery. Meaningful change (responsiveness) in the acute to subacute phase of stroke recovery has not been determined. Determine responsiveness and sensitivity to change of the FMA-UE from 1-week to 6-weeks (subacute) after stroke in individuals with moderate to severe arm impairment who received standard clinical care. A total of 51 participants with resulting moderate and severe UE hemiparesis after stroke had FMA-UE assessment at baseline (within 2 weeks of stroke) and 6-weeks later. Sensitivity to change was assessed using Glass's delta, standardized response means (SRM), standard error of measure (SEM), and minimal detectable change (MDC). Responsiveness was assessed with the minimal clinically important difference (MCID), estimated using receiver operating characteristic curve analysis with patient-reported global rating of change scales (GROC) and a provider-reported modified Rankin Scale (mRS) as anchors. The MCID estimates were 13, 12, and 9 anchored to the GROC Arm Weakness, GROC Recovery, and mRS. Glass's delta and the SRM revealed large effect sizes, indicating high sensitivity to change, (∆ = 1.24, 95% CI [0.64, 1.82], SRM = 1.10). Results for the SEM and MDC were 2.46 and 6.82, respectively. The estimated MCID for the FMA-UE for individuals with moderate to severe motor impairment from 1 to 6-weeks after stroke is 13. These estimates will provide clinical context for FMA-UE change scores by helping to identify the change in upper-extremity motor impairment that is both beyond measurement error and clinically meaningful.

Investigating force-time characteristics of prone thoracic SMT and self-reported patient outcome measures: a feasibility study

BackgroundSpinal manipulative therapy (SMT) is commonly used to treat musculoskeletal conditions, including thoracic spine pain. Applying patient-specific force-time characteristics are believed to be important to improve SMT’s effectiveness. Investigating SMT as part of a multimodal approach is fundamental to account for the complexity of chiropractic clinical practice. Therefore, pragmatic investigations balancing minimal disruptions to the clinical encounter at the same time as ensuring a robust data quality with rigorous protocols are needed. Consequently, preliminary studies are required to assess the study protocol, quality of data recorded and the sustainability of such investigation. Therefore, this study examined the feasibility of investigating SMT force-time characteristics and clinical outcome measures in a clinical setting.MethodsIn this mixed-methods study, providers recorded thoracic SMT force-time characteristics delivered to patients with thoracic spinal pain during regular clinical encounters. Self-reported clinical outcomes of pain, stiffness, comfort during the SMT (using an electronic visual analogue scale), and global rating of change scale were measured before and after each SMT application. Feasibility was quantitatively assessed for participant recruitment, data collection and data quality. Qualitative data assessed participants’ perceptions on the impact of data collection on patient management and clinical flow.ResultsTwelve providers (58% female, 27.3 ± 5.0 years old) and twelve patients (58% female, 37.2 ± 14.0 years old) participated in the study. Enrolment rate was greater than 40%, data collection rate was 49% and erroneous data was less than 5%. Participant acceptance was good with both providers and patients reporting positive experience with the study.ConclusionsRecording SMT force-time characteristics and self-reported clinical outcome measures during a clinical encounter may be feasible with specific modification to the current protocol. The study protocol did not negatively impact patient management. Specific strategies to optimize the data collection protocol for the development of a large clinical database are being developed.

Responsiveness and the Minimal Important Change of Knee Injury and Osteoarthritis Outcome Score Following Physiotherapy Intervention in Iraqi People with Knee Osteoarthritis

Background: The Knee Injury Osteoarthritis Outcome Score (KOOS) is a widely used patient-reported questionnaire to evaluate individuals with knee osteoarthritis or a history of knee injuries. Objectives: The aim of this study was to evaluate the responsiveness and establish the minimal important change (MIC) for the Arabic version of KOOS in Iraqi individuals with knee osteoarthritis following physiotherapy intervention. Methods: Fifty volunteers (13 male and 37 female, mean age: 59.3±9.6 years old) with an orthopedic diagnosis of knee osteoarthritis participated in this study. The Arabic KOOS was completed by the participants once before the intervention and once after completing a 4-week physiotherapy treatment program. A seven-item global rating of change scale was used as an external anchor to assess the participants' opinion about the treatment and its possible changes. Responsiveness was evaluated by calculating the receiver operating characteristic (ROC) curve, and the MIC was established by identifying an optimal cut-off on the ROC curve. Results: All subscales of the Arabic KOOS showed an area under the curve &gt; 0.70. The MICs reflecting the values required by the participants to feel the improvement were 15.5, 14.5, 11, 11.5, and 12.5 for the pain, symptoms, activities of daily living, sports and recreation, and quality of life subscales, respectively. Conclusions: All subscales of the Arabic KOOS are responsive to physiotherapy treatment. Therapists and researchers can use the MIC values to evaluate whether their prescribed treatment was satisfactory and effective from their patients' point of view.

Cross-cultural adaptation and validation of the Northwick park neck pain questionnaire to Urdu language

BackgroundDespite its widespread use for assessing pain and disability in patients suffering from neck pain, the Northwick Park Neck Pain Questionnaire (NPQ) has yet to be translated and validated in Urdu. The purpose of the present study was to translate and cross-culturally adapt the NPQ into Urdu language (NPQ-U), and to investigate the NPQ-U’s psychometric properties in patients with non-specific neck pain (NSNP).MethodsThe NPQ was translated and cross-culturally adapted into Urdu in accordance with the previously described guidelines. The study included 150 NSNP patients and 50 healthy participants. The NPQ-U, Urdu version of neck disability index (NDI-U), neck pain and disability scale (NPDS), and numerical pain rating scale (NPRS) were completed by all participants on first visit. After three weeks of physical therapy, the patients completed all of the questionnaires listed above, along with the global rating of change scale. Test-retest reliability was determined on 46 randomly selected patients who completed the NPQ-U again two days after the first response. The NPQ-U was evaluated for internal consistency, content validity, construct (convergent and discriminative) validity, factor analysis, and responsiveness.ResultsThe NPQ-U demonstrated excellent test-retest reliability (intra-class correlation coefficient = 0.96) and high internal consistency (Cronbach’s alpha = 0.89). There were no floor or ceiling effects for the NPQ-U total score, indicating good content validity. A single factor was extracted, which explained 54.56% of the total variance. For convergent validity, the NPQ-U showed a strong correlation with NDI-U (r = 0.89, P < 0.001), NPDS (r = 0.71, P < 0.001), and NPRS (r = 0.73, P < 0.001). The results revealed a significant difference between patients and healthy controls in the NPQ-U total scores (P < 0.001) demonstrating significant discriminative validity. A significant difference in the NPQ-U change scores between the stable and the improved groups (P < 0.001) confirmed its responsiveness. Furthermore, the NPQ-U change score showed a moderate correlation with NPDS change score (r = 0.60, P < 0.001) and NPRS change score (r = 0.68, P < 0.001), but a strong correlation with NDI-U change score (r = 0.75, P < 0.001).ConclusionThe NPQ-U is a reliable, valid, and responsive tool for assessing neck pain and disability in Urdu-speaking patients with NSNP.

Translation and validation of the Urdu version of the neck pain and disability scale

Purpose To translate and cross-culturally adapt the neck pain and disability scale (NPDS) into Urdu language (NPDS-U), and to investigate the NPDS-U’s psychometric properties in patients with non-specific neck pain (NSNP). Methods The NPDS was translated and cross-culturally adapted into Urdu in accordance with the previously described guidelines. The study included 200 NSNP patients and 50 healthy participants. The NPDS-U, Urdu version of neck disability index (NDI-U), neck Bournemouth questionnaire (NBQ), and numerical pain rating scale (NPRS) were completed by all participants. After three weeks of physiotherapy, the patients completed all of the above-mentioned questionnaires, along with the global rating of change scale. Reliability, factor analysis, validity, and responsiveness were all tested. Results The NPDS-U demonstrated excellent test-retest reliability (ICC2,1=0.92) and high internal consistency (Cronbach’s alpha = 0.96). There were no floor or ceiling effects. A three-factor structure was extracted, which explained 70.42% of the total variance. The NPDS-U showed moderate to strong correlations with NPRS, NDI-U, and NBQ (r = 0.67–0.76, p < 0.001). A significant difference in the NPDS-U change scores between the stable and the improved groups (p < 0.001) confirmed its responsiveness. Conclusion The NPDS-U is a reliable, valid, and responsive scale for assessing neck pain and disability in Urdu-speaking patients with NSNP.

Recommendations for a core outcome measurement set for clinical trials in whiplash associated disorders.

Inconsistent reporting of outcomes in clinical trials of treatments for whiplash associated disorders (WAD) hinders effective data pooling and conclusions about treatment effectiveness. A multidisciplinary International Steering Committee recently recommended 6 core outcome domains: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life and Pain. This study aimed to reach consensus and recommend a core outcome set (COS) representing each of the 6 domains. Forty-three patient-reported outcome measures (PROMs) were identified for Physical Functioning, 2 for perceived recovery, 37 for psychological functioning, 17 for quality of life, and 2 for pain intensity. They were appraised in 5 systematic reviews following COSMIN methodology. No PROMs of Work and Social Functioning in WAD were identified. No PROMs had undergone evaluation of content validity in patients with WAD, but some had moderate-to-high-quality evidence for sufficient internal structure. Based on these results, the International Steering Committee reached 100% consensus to recommend the following COS: Neck Disability Index or Whiplash Disability Questionnaire (Physical Functioning), the Global Rating of Change Scale (Perceived Recovery), one of the Pictorial Fear of Activity Scale-Cervical, Pain Self-Efficacy Questionnaire, Pain Catastrophizing Scale, Harvard Trauma Questionnaire, or Posttraumatic Diagnostic Scale (Psychological Functioning), EQ-5D-3L or SF-6D (Quality of Life), numeric pain rating scale or visual analogue scale (Pain), and single-item questions pertaining to current work status and percent of usual work (Work and Social Functioning). These recommendations reflect the current status of research of PROMs of the 6 core outcome domains and may be modified as evidence grows.