Validated Outcome Measures Research Articles

Resilience in Oral Health Professional Education: A Scoping Review.

Resilience is defined as an individual's capacity to effectively adapt in the face of challenges without detrimental effects on their health and well-being. This scoping review identifies and rationalises the published concepts that underpin resilience in oral health professional (OHP) education. It provides recommendations for the development of evidence-based strategies for promoting resilience in OHP education. The PRISMA and Arksey and O'Malley methodological frameworks for scoping reviews were used to determine the methodology and answer the question 'What concepts contribute to resilience in OHP Education?'. The search strategy included published literature searches and internet searches. In total, 744 articles on resilience and coping were identified, and 59 were included after excluding irrelevant records. Most studies used surveys as their study design and focused on undergraduate dental students in North America and Asia. Three main themes were identified: factors that contribute to resilience, measurement tools and scales and enhancing resilience. This review highlights a positive correlation between increased resilience and improved outcomes for dental students. Resilience and its related factors are not well understood. There is insufficient evidence to support interventions for building resilience due to inconsistent measuring methods and limited research validating resilience scales in OHP education. Investigators should accurately understand the terminology for clarity and consistency. Validated outcome measures and student feedback should be used to determine the effectiveness of interventions. It is important to teach students coping strategies to manage stressors, and digital applications for building resilience should be developed and tested in OHP student populations.

The effect of blended tube feeding compared to conventional formula on clinical outcomes in adults: A systematic review.

To explore the effect of blended tube feeding compared to conventional formulas on nutritional status, quality of life, anthropometry, diarrhoea and tube blockages in adults receiving tube feeding. The protocol was registered (PROSPERO CRD42022372443). Five databases (MEDLINE, EMBASE, CINAHL, Scopus, CENTRAL) were searched from commencement of database to 14th June 2023 to identify studies comparing blended tube feeding to conventional formulas in adults receiving tube feeding. Certainty assessment was conducted using the Cochrane Risk of Bias Tools and the Grading of Recommendations, Assessment, Development and Evaluations framework, and a narrative synthesis of results is provided. From 4227 studies screened, eight were included (total n = 763 patients, 9-215 patients). Three studies were hospital-based and five were home-based with duration from 8 days-8 months. Blended tube feeding and conventional formulas were nutritionally equivalent in only three studies; energy and protein concentration of formulas ranged from 1.7-7.1 kJ/mL and 21-68.5 g/L for the blended tube feeding groups, and 4.2-6.7 kJ/mL and 39-100 g/L for the conventional groups. No studies assessed nutrition status or quality of life using validated measures. Blended tube feeding was associated with a clinically relevant reduction in diarrhoea with a low level of certainty. For remaining outcomes, there were inconclusive findings and an overall very low certainty of evidence for each. The effect of blended tube feeding compared to conventional formulas on all outcomes remains uncertain. Blended tube feeding may reduce the incidence of diarrhoea. Future research using nutritionally equivalent comparisons and validated outcome measures is required.

Comparing mechanical and enzymatic isolation procedures to isolate adipose-derived stromal vascular fraction: A systematic review.

The stromal vascular fraction of adipose tissue has gained popularity as regenerative therapy for tissue repair. Both enzymatic and mechanical intraoperative SVF isolation procedures exist. To date, the quest for the preferred isolation procedure persists, due to the absence of standardised yield measurements and a defined clinical threshold. This systematic review is an update of the systematic review published in 2018, where guidelines were proposed to improve and standardise SVF isolation procedures. An elaborate data search in MEDLINE (PubMed), EMBASE (Ovid) and the Cochrane Central Register of Controlled Trials was conducted from September 2016 to date. A total of 26 full-text articles met inclusion criteria, evaluating 33 isolation procedures (11 enzymatic and 22 mechanical). In general, enzymatic and mechanical SVF isolation procedures yield comparable outcomes concerning cell yield (2.3-18.0 × 105 resp. 0.03-26.7 × 105 cells/ml), and cell viability (70%-99% resp. 46%-97.5%), while mechanical procedures are more time consuming (8-20 min vs. 50-210 min) and cost-efficient. However, as most studies used poorly validated outcome measures on SVF characterisation, it still remains unclear which intraoperative SVF isolation method is preferred. Future studies are recommended to implement standardised guidelines to standardise methods and improve comparability between studies.

MuscleMap: An Open-Source, Community-Supported Consortium for Whole-Body Quantitative MRI of Muscle

Disorders affecting the neurological and musculoskeletal systems represent international health priorities. A significant impediment to progress in trials of new therapies is the absence of responsive, objective, and valid outcome measures sensitive to early disease changes. A key finding in individuals with neuromuscular and musculoskeletal disorders is the compositional changes to muscles, evinced by the expression of fatty infiltrates. Quantification of skeletal muscle composition by MRI has emerged as a sensitive marker for the severity of these disorders; however, little is known about the composition of healthy muscles across the lifespan. Knowledge of what is ‘typical’ age-related muscle composition is essential to accurately identify and evaluate what is ‘atypical’. This innovative project, known as the MuscleMap, will achieve the first important steps towards establishing a world-first, normative reference MRI dataset of skeletal muscle composition with the potential to provide valuable insights into various diseases and disorders, ultimately improving patient care and advancing research in the field.

Development and Validation of the Youth Back Activity Questionnaire: A Measure of Function for Adolescents with Low Back Pain.

Psychometric study. To develop a reliable and valid patient-reported outcome measure to assess functional ability in adolescents with low back pain (LBP) using the Rasch model. LBP is quite common in adolescence. Currently, no method adequately measures the functional ability of adolescents with LBP. Widely used outcome measures for LBP are problematic in adolescents, with significant ceiling/floor effects. Two hundred adolescents (15.4 ± 1.9 years; 56% female) with LBP. This study was comprised of two parts: Part 1: Development of the Youth Back Activity Questionnaire (YouthBAQ) (n = 75), and Part 2: Psychometric evaluation of the newly designed YouthBAQ using the Rasch Model (n = 125). Participants also completed the Oswestry Disability Index (ODI) and Micheli Functional Scale (MFS), Data Analysis: Reliability and construct validity of the YouthBAQ were assessed using Rasch analyses. Correlations with the ODI and MFS were used to determine the convergent validity of the YouthBAQ. Part 1: Based on the results of the Rasch analysis, 31 items were reduced to 14. Part 2. The 14-item YouthBAQ demonstrated good reliability and construct validity, with good item fit (>0.7 and <1.3), acceptable item hierarchy and spacing, response category functioning, unidimensionality (ratio >3:1), local independence (<0.30). The MFS demonstrated unacceptable reliability (person reliability = 0.62) and was not compared against the YouthBAQ. The ODI demonstrated acceptable reliability (person reliability =0.70), but poor construct validity among adolescents with LBP. The YouthBAQ demonstrated a moderate correlation with the ODI (r = 0.4). The YouthBAQ is a quick and easily understood measure of function with good validity and reliability in adolescents with LBP. The YouthBAQ is a more appropriate measure of functional ability than the ODI or MFS in this population.

External validation of the smartphone-based 6-minute walking test in patients with degenerative lumbar disorders undergoing epidural steroid injection

BackgroundThe 6-minute walking test (6WT) has previously shown to be reliable and valid outcome measure in patients undergoing surgery for degenerative lumbar disorders (DLD). A role of 6WT in conservatively treated patients undergoing epidural steroid injection (ESI) remains unclear. MethodsAbout 50 patients with DLD, scheduled for ESI were assessed by the smartphone-based 6WT and common paper-based patient-reported outcome measures (PROMs), including the Core Outcome Measures Index [COMI] back, Oswestry Disability Index (ODI) and Short Form Survey (SF-12). Pearson correlation coefficient (PCC) was used to define the relationship between 6WT and PROMs. Reliability of the 6WT was determined by intraclass correlation coefficient (ICC). Age- and sex-adjusted objective functional impairment (OFI) z-scores were calculated for each patient. ResultsA total of 50 patients (mean age 52 years, SD 13; 25% female), including 35 patients (70%) with lumbar disc herniation and 15 patients (30%) with lumbar spinal stenosis were included. The mean 6-minute walking distance (6WD) was 454.1 m (SD 89.1); the age- and sex-adjusted mean OFI z-score was −2.1 (SD 4.0). A total of 17 (34%) patients had mild, 8 (16%) moderate, and 4 (8%) severe OFI, while 21 (42%) had 6WT results within the normal population range (no OFI). The PCCs between the 6WD and VAS back pain were r=−0.30, ODI r=−0.43, COMI back r=−0.36, and PCS-12 r=0.51 (all p<.05). The ICC of the 6WT was β=0.92. ConclusionsThis external validation in a patient cohort with DLD, which was managed conservatively, confirms the reliability and content validity of the 6WT with similar PCCs with PROMs compared to the original surgical cohort. The results confirm the 6WT as a valid and useful tool for assessing OFI in patients with DLD and a broad range of functional restrictions in an outpatient setting.

Assistive technologies, including orthotic devices, for the management of contractures in adults after a stroke.

Contractures (reduced range of motion and increased stiffness of a joint) are a frequent complication of stroke. Contractures can interfere with function and cause cosmetic and hygiene problems. Preventing and managing contractures might improve rehabilitation and recovery after stroke. To assess the effects of assistive technologies for the management of contractures in adults after a stroke. We searched CENTRAL, MEDLINE, Embase, five other databases, and three trials registers in May 2022. We also searched for reference lists of relevant studies, contacted experts in the field, and ran forward citation searches. Randomised controlled studies (RCTs) that used electrical, mechanical, or electromechanical devices to manage contractures in adults with stroke were eligible for inclusion in this review. We planned to include studies that compared assistive technologies against no treatment, routine therapy, or another assistive technology. Three review authors (working in pairs) selected all studies, extracted data, and assessed risk of bias. The primary outcomes were passive joint range of motion (PROM) with and without standardised force, and indirect measures of PROM. The secondary outcomes included hygiene. We also wanted to evaluate the adverse effects of assistive technology. Effects were expressed as mean differences (MDs) or standardised mean differences (SMDs) with 95% confidence intervals (CIs). Seven studies fulfilled the inclusion criteria. Five of these were meta-analysed; they included 252 adults treated in acute and subacute rehabilitation settings. All studies compared assistive technology with routine therapy; one study also compared assistive technology with no treatment, but we were unable to obtain separate data for stroke participants. The assistive technologies used in the studies were electrical stimulation, splinting, positioning using a hinged board, and active repetitive motor training using a non-robotic device with electrical stimulation. Only one study applied stretching to end range. Treatment duration ranged from four to 12 weeks. The overall risk of bias was high for all studies. We are uncertain whether: • electrical stimulation to wrist extensors improves passive range of wrist extension (MD -7.30°, 95% CI -18.26° to 3.66°; 1 study, 81 participants; very low-certainty evidence); • a non-robotic device with electrical stimulation to shoulder flexors improves passive range of shoulder flexion (MD -9.00°, 95% CI -25.71° to 7.71°; 1 study; 50 participants; very low-certainty evidence); • assistive technology improves passive range of wrist extension with standardised force (SMD -0.05, 95% CI -0.39 to 0.29; four studies, 145 participants; very low-certainty evidence): • a non-robotic device with electrical stimulation to elbow extensors improves passive range of elbow extension (MD 0.41°, 95% CI -0.15° to 0.97°; 1 study, 50 participants; very low-certainty evidence). One study reported the adverse outcome of pain when using a hinged board to apply stretch to wrist and finger flexors, and another study reported skin breakdown when using a thumb splint. No studies reported hygiene or indirect measures of PROM. Only seven small RCTs met the eligibility criteria of this review, and all provided very low-certainty evidence. Consequently, we cannot draw firm conclusions on the effects of assistive technology compared with routine therapy or no therapy. It was also difficult to confirm whether there is a risk of harm associated with treatment using assistive technology. Future studies should apply adequate treatment intensity (i.e. magnitude and the duration of stretch) and use valid and reliable outcome measures. Such studies might better identify the role of assistive technology in the management of contractures in adults after a stroke.

Step Test Evaluation of Performance on Stairs (STEPS): Assessing Stair Function in Older Adults.

Stair negotiation is crucial for functional independence and is a leading cause of fall-related injuries in older adults. The Step Test Evaluation of Performance on Stairs (STEPS) is a quick and easily administered outcome measure for assessing stair negotiation. This study investigated the reliability and concurrent content validity of the STEPS test to determine its usefulness in older adults. Eighty-two community-dwelling older adults (mean age 81.2years, 51 females) were assessed on the STEPS test, Timed Up and Go (TUG), 5-times sit to stand (5XSTS), stair self-efficacy (SSE) questionnaire, and time to ascend and descend stairs. Participants repeated the STEPS test 7 to 14days later for intrarater reliability by the same rater. Spearman rank and intraclass correlations were used to determine the association of measures and intrarater reliability. The mean STEPS score was 15.6 (SD=3.7) out of 20. The STEPS total score demonstrated excellent intra- and interrater reliability. It had moderate to good and significant correlations with TUG, 5XSTS, SSE, and time to ascend and descend measures. Faster performance on the 5XSTS, TUG, and time to ascend and descend correlated with better performance on the STEPS test, indicating validity for assessing balance and mobility during stair negotiation in older adults. Lower SSE correlated with lower observer ratings of performance on stairs (STEPS scores), indicating agreement between participant reports of self-efficacy and observer ratings of performance. Step Test Evaluation of Performance on Stairs items that demonstrated the most frequent loss of points were balance (use of handrail), step continuity, foot placement, and self-propulsion (ascent only). Assessment of older adults' safety and performance on stairs is vital given the increased difficulty of stair navigation and the high risk for injurious falls in this population. This study demonstrates that the STEPS test is a reliable and valid outcome measure for assessing stair performance in older adults.

A useful cognitive motor dual task paradigm in prodromal and manifest Huntington’s disease

IntroductionIndividuals with Huntington's disease (HD) experience increased difficulty with balance throughout disease progression. Adding a simultaneous cognitive task to a balance assessment, referred to as a dual task (DT) paradigm, may have a deleterious effect on balance, which can be expressed in terms of a Dual Task Cost (DTC), relative to a single task (ST) condition. The aim of this study is to explore whether a cognitive-motor DT paradigm uncovers balance deficits in prodromal (Pro-HD) and manifest HD, compared to healthy adults (HA). MethodsBalance under ST and DT conditions was examined using the BTracks Balance Plate and Balance software in 30 individuals with HD, 17 individuals with Pro-HD, and 20 HA. During the DT condition, participants were simultaneously administered a version of the Paced Auditory Serial Addition Test (PASAT). DTC is calculated as the relative ratio of ST to DT, controlling for ST performance: DTC= (ST − DT)/ST x100. ResultsThe HA group performed significantly better than the HD group on both the ST and DT conditions (p < 0.01), while balance scores between the HA and the Pro-HD groups were not significantly different. The DTC scores, however, were significantly better in the HA compared to both the HD (p < 0.001) and Pro-HD (p < 0.05) groups. ConclusionOur findings indicate that the addition of a cognitive task interferes with participant's balance, reflecting real-life performance, and may have additional value for estimating transition to manifest disease, appraising fall risk, or serving as a valid outcome measure in observational and interventional trials in HD.

Artificial intelligence for optimizing recruitment and retention in clinical trials: a scoping review.

The objective of our research is to conduct a comprehensive review that aims to systematically map, describe, and summarize the current utilization of artificial intelligence (AI) in the recruitment and retention of participants in clinical trials. A comprehensive electronic search was conducted using the search strategy developed by the authors. The search encompassed research published in English, without any time limitations, which utilizes AI in the recruitment process of clinical trials. Data extraction was performed using a data charting table, which included publication details, study design, and specific outcomes/results. The search yielded 5731 articles, of which 51 were included. All the studies were designed specifically for optimizing recruitment in clinical trials and were published between 2004 and 2023. Oncology was the most covered clinical area. Applying AI to recruitment in clinical trials has demonstrated several positive outcomes, such as increasing efficiency, cost savings, improving recruitment, accuracy, patient satisfaction, and creating user-friendly interfaces. It also raises various technical and ethical issues, such as limited quantity and quality of sample size, privacy, data security, transparency, discrimination, and selection bias. While AI holds promise for optimizing recruitment in clinical trials, its effectiveness requires further validation. Future research should focus on using valid and standardized outcome measures, methodologically improving the rigor of the research carried out.

Cognitive Distortion Scale for Bangladesh: Development and Properties

The purpose of the study was to develop a scale for assessing cognitive distortions in Bangladesh and establishing psychometric properties for Bangladeshi population. The scale was named as Bangladesh Cognitive Distortion Scale (BCDS). Items were constructed through three stages of intensive expert evaluation where 128 respondents participated and both item analysis and factor analysis were undertaken. Finalized BCDS with 39 items was administered to 478 respondents to calculate its psychometric properties. Concurrent validity of BCDS was found 0.828 by calculating correlation between the score of BCDS and clinician’s subjective rating. Predictive validity considering anxiety and depression scale was found 0.756 and 0.841, respectively. Convergent validity (0.670) was confirmed through the correlation between the DAS and BCDS and divergent validity was established by the discriminate value (F=649.564, α&lt;0.01) of clinical and non-clinical groups. Internal consistency reliability of BCDS (Cronbach Alpha- 0.962 and test-retest- 0.890) was found very high. The cut-off point for measuring cognitive distortion by BCDS was found 56 with sensitivity 87% and specificity 88%. According to the percentile norm, total score 56 to 72, 73 to 91, 92 to 109, 110 and above represents the mild, moderate, severe, and profound levels of cognitive distortions respectively. BCDS not only will help both clinicians and researchers to assess cognitive distortions within a short time but also could be used as a valid and reliable outcome measure in cognitive behavior therapy. Dhaka Univ. J. Biol. Sci. 33(2): 97-109, 2024 (July)

The Indian Geriatrics Quality of Life Inventory Scale (IGQOLI): Development and Validation of a Scale to Evaluate the Quality of Life among Geriatric Population of India.

Quality of life (QOL) refers to an individual's perception of their overall life and well-being. As people age, their QOL often deteriorates. Although various outcome measures exist to assess QOL, most are limited in scope and not specific to the Indian ethnicity of geriatrics. Therefore, a new outcome measure was developed and validated to more accurately evaluate the QOL for the geriatric population in India. The outcome measure was developed in three stages, followed by validation. Data was collected using multistage cluster sampling from 13 subdivisions of Jaipur district. A total of 423 participants were interviewed face-to-face. The collected data was analyzed using SPSS version 20, and the reliability and validity of the outcome measure were assessed. The Indian Geriatrics Quality of Life Inventory (IGQOL) scale demonstrated excellent reliability, with a Cronbach's alpha (α) of 0.95 and an intraclass correlation coefficient of 0.93. The measure also exhibited excellent face and content validity, with a K value of 1. Correlation analysis revealed a significant relationship with other outcome measures, with a Pearson correlation coefficient value of > 7 and a p-value of < 0.05. The study concludes that the IGQOLI scale is a reliable and valid outcome measure for evaluating the QOL in the geriatric population in India.

Improving outcome measures in late onset Pompe disease: Modified Rasch-Built Pompe-Specific Activity scale.

The Rasch-Built Pompe-Specific Activity (R-PAct) scale is a patient-reported outcome measure specifically designed to quantify the effects of Pompe disease on daily life activities, developed for use in Dutch- and English-speaking countries. This study aimed to validate the R-PAct for use in other countries. Four other language versions (German, French, Italian, and Spanish) of the R-PAct were created and distributed among Pompe patients (≥16 years old) in Germany, France, Spain, Italy, and Switzerland and pooled with data of newly diagnosed patients from Australia, Belgium, Canada, the Netherlands, New Zealand, the USA, and the UK and the original validation cohort (n = 186). The psychometric properties of the scale were assessed by exploratory factor analysis and Rasch analysis. Data for 520 patients were eligible for analysis. Exploratory factor analysis suggested that the items separated into two domains: Activities of Daily Living and Mobility. Both domains independently displayed adequate Rasch model measurement properties, following the removal of one item ("Are you able to practice a sport?") from the Mobility domain, and can be added together to form a "higher order" factor as well. Differential item functioning (DIF)-by-language assessment indicated DIF for several items; however, the impact of accounting for DIF was negligible. We recalibrated the nomogram (raw score interval-level transformation) for the updated 17-item R-PAct scale. The minimal detectable change value was 13.85 for the overall R-PAct. After removing one item, the modified-R-PAct scale is a valid disease-specific patient-reported outcome measure for patients with Pompe disease across multiple countries.

Parent-reported outcome measures evaluating communication in individuals with rare neurodevelopmental disorders: A systematic review.

Communication impairments are a leading concern for parent caregivers of individuals with rare neurodevelopmental disorders (RNDDs). Clinical trials of disease modifying therapies require valid and responsive outcome measures that are relevant to individuals with RNDDs. Identifying and evaluating current psychometric properties for communication measures is a critical step towards the selection and use of appropriate instruments. This systematic review offers (1) a description of parent-reported communication measures and (2) evidence for their psychometric properties, in RNDDs. The systematic review protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO; CRD42022334649). MEDLINE (Ovid), Embase, PsychINFO, Web of Science, CINAHL Plus, Cochrane Library, ClinicalTrials.gov, the Australian New Zealand Clinical Trials Registry were searched from inception to August 2023. Methodological assessment of quality was completed using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. Parent-reported measures used in observational studies and clinical trials were identified. Data on utility, reliability and validity for RNDDs were extracted. Sixteen parent-reported communication measures were used in RNDD research, the Vineland Adaptive Behavior Scales being most commonly used. Validation data in RNDDs were identified for six of these measures. Limitations related to sample size or the scope of psychometric testing. Many communication measures have been used for RNDDs but there are few data validating their use. Valid and reliable methods of measuring communication in persons with RNDDs is a priority for future high-quality clinical trials. What is already known on the subject Communication is a critical domain for families with a child with a rare neurodevelopmental disorder (RNDD). Validated outcome measures are essential for accurate evaluation and interpretation of responses to treatments in clinical trials. What this paper adds to existing knowledge We identified 16 parent-reported communication measures that have been used with RNDDs, but only six measures had validation data for at least one RNDD. High quality evidence is accumulating, with all validation studies in this review published between 2020 to 2023. Modifications of existing measures may be required to assess communication for RNDDs. What are the clinical implications of this work? This systematic review catalogues the available psychometric data for communication measures and indicates an ongoing need for new validation studies to ensure they are fit-for-purpose for upcoming clinical trials in RNDDs. This review will inform the selection of communication measures for clinical trials and research studies.

Development and validation of the Oral Lichen Planus-Disease Activity Scale: a novel tool for comprehensive clinical assessment.

To develop and validate the Oral Lichen Planus-Disease Activity Scale (OLP-DAS) for assessing overall disease activity of OLP. The OLP-DAS was created by refining the Thongprasom criteria, incorporating inputs from the literature and expert review, and integrating pain assessment. Content validity was evaluated in a virtual meeting with 8 Oral Medicine specialists. Reliability and validity of the final version were examined. Seventeen OLP subjects were assessed for disease activity by 10 investigators using the OLP-DAS, Oral Disease Severity Score (ODSS), OLP-Investigator Global Assessment (OLP-IGA), and Reticular-Erythema-Ulcerative (REU) scale. Convergent validity was assessed by rating 160 OLP subjects using the OLP-DAS, ODSS, and OLP-IGA. Inter-rater and intra-rater reliability, along with convergent validity, were analyzed using intraclass correlation coefficients (ICCs) and Spearman's rank correlation coefficients (rs). The final OLP-DAS achieved excellent content validity indices. Inter-rater and intra-rater ICCs for total OLP-DAS scores were 0.93 and 0.96, respectively. Total OLP-DAS scores exhibited strong positive correlations with the ODSS and OLP-IGA (rs = 0.94 and rs = 0.76; P < 0.001, respectively). The OLP Severity Index (OLP-SI), a component of the OLP-DAS, showed very strong positive correlations with OLP disease activity parameters of the ODSS (rs = 0.90; P < 0.001). The OLP-DAS is a valid and reliable clinician-reported outcome measure (CROM) for evaluating OLP disease activity. The OLP-DAS, as a standardized CROM for OLP, is valuable for both routine clinical assessments and research applications.

The Myanmar Version of the Oswestry Disability Questionnaire: A Cross-Cultural Adaptation, Reliability and Validity Study in the Low Back Pain Population

Objective: To translate and cross-culturally adapt the Myanmar version of the Oswestry Disability Questionnaire (M-ODQ), and examine its reliability and validity in the low back pain (LBP) population. Material and Methods: The M-ODQ was cross-culturally adapted in accordance with the ISPOR guidelines for translation. Prefinal testing was done on 20 individuals with LBP, with minor changes. The test-retest reliability, internal consistency, concurrent and construct validity, plus ceiling and floor effects of the M-ODQ were conducted on 101 individuals with LBP, via calculating the intraclass correlation coefficient ICC(2,1), Cronbach’s alpha, and Spearman’s rank correlation coefficient by correlating with the Myanmar version of the Roland-Morris Disability Questionnaire (M-RMDQ), visual analogue scale (VAS), back performance scale (BPS), and the Stark quality of life (QoL) questionnaire. The level of significance was set at p-value&lt;0.05 for all statistical analyses.Results: The test-retest reliability and internal consistency of the M-ODQ showed an ICC(2,1) of 0.91 and a Cronbach’s alpha of 0.703, thus indicating that the M-ODQ had an acceptable level of reliability. A moderate correlation between the M-ODQ and M-RMDQ (rho=0.56); and fair correlation with the VAS (rho=0.253), BPS (rho=0.336), and the physical component of the Stark QoL questionnaire (rho= -0.274) were found. Weak or no correlation was demonstrated with the mental component of the Stark QoL questionnaire (rho= -0.204). No ceiling or floor effects of the M-ODQ occurred in this study. Conclusion: The M-ODQ is a reliable and valid outcome measure for assessing disability among LBP patients in the Myanmar population.

Disability in cluster headache is more than attack frequency - results from and validation of the English version of the Cluster Headache Impact Questionnaire (CHIQ)

BackgroundCluster headache (CH) is associated with high disability. The Cluster Headache Impact Questionnaire (CHIQ) is a short, disease-specific disability questionnaire first developed and validated in German. Here, we validated the English version of this questionnaire.MethodsThe CHIQ was assessed together with nonspecific headache-related disability questionnaires in CH patients from a tertiary headache center and an American self-help group. Results155 active episodic and chronic CH patients were included. The CHIQ showed good internal consistency (Cronbach’s α = 0.91) and test-retest reliability (ICC = 0.93, n = 44). Factor analysis identified a single factor. Convergent validity was shown by significant correlations with the Headache Impact Test™ (HIT-6™, ρ = 0.72, p < 0.001), the Hospital Anxiety and Depression Scale (HADS depression: ρ = 0.53, HADS anxiety: ρ = 0.61, both p< 0.001), the Perceived Stress Scale (PSS-10, ρ = 0.61, p < 0.001) and with CH attack frequency (ρ = 0.29, p < 0.001). Chronic CH patients showed the highest CHIQ scores (25.4 ± 7.9, n = 76), followed by active episodic CH and episodic CH patients in remission (active eCH: 22.2 ± 8.7, n = 79; eCH in remission: 14.1 ± 13.1, n = 127; p < 0.001). Furthermore, the CHIQ was graded into 5 levels from “no to low impact” to “extreme impact” based on the patients’ perception. Higher CHIQ grading was associated with higher attack and acute medication frequency, HIT-6™, HADS and PSS scores.ConclusionThe English version of the CHIQ is a reliable, valid, and disease-specific patient-reported outcome measure to assess the impact of headaches on CH patients.

Single-Row Repair Versus Double-Row Repair in the Surgical Management of Achilles Insertional Tendinopathy: A Systematic Review.

Approximately 6% of people will report Achilles tendon pain during their lifetime, and one-third of these individuals will have Achilles insertional tendinopathy (AIT). For patients who have failed conservative treatment, surgical repair is performed. Achilles tendon repair can occur through various techniques, including a single-row or double-row repair. To determine if there are significant advantages to double-row repair over single-row repair with respect to biomechanical and clinical outcomes. Systematic review; Level of evidence, 3. A systematic review of the literature was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. An electronic search of the EMBASE and PubMed databases was performed for all studies related to surgical treatment of AIT, which yielded 1431 unique results. These included both biomechanical and clinical studies. Clinical studies in which patients were not diagnosed with AIT, underwent surgery for repair of acute Achilles tendon rupture, or studies that included additional procedures such as a concomitant flexor hallucis longus transfer were excluded. Eligible studies were independently screened by 2 reviewers. A risk-of-bias assessment was conducted using the Cochrane Risk Of Bias In Non-randomized Studies-of Interventions and risk-of-bias tool for randomized trials tools. A total of 23 studies were included, 4 of which were biomechanical studies and 19 were clinical studies. Biomechanical comparison found that there was a significant advantage to using double-row versus single-row fixation with respect to load at yield (354.7 N vs 198.7 N; P = .01) and mean peak load (433.9 N vs 212 N; P = .042). There was no significant difference between double-row and single-row repair with respect to load to failure. Significant heterogeneity of the studies did not allow for a statistical comparison of the clinical outcomes between double-row and single-row repairs. Although biomechanical studies favor double-row repair for AIT, the current data available on the clinical outcomes are not sufficient to determine if there is a clinical advantage of double-row repair. Larger, prospective randomized controlled trials utilizing validated outcome measures are needed to further elucidate whether the biomechanical advantages associated with double-row repair also translate into improved patient-reported outcomes.

Exercise and Cognitive Function Chronic Kidney Disease: A Systematic Review and Meta-Analysis of Efficacy and Harms.

People living with chronic kidney disease (CKD) are at higher risk of cognitive impairment. Exercise may improve cognitive function. This systematic review and meta-analysis of randomized controlled trials (RCTs) was completed to determine the efficacy and harms of exercise in improving cognitive function in people living with CKD. A systematic literature review identified RCTs of people with any stage of CKD, with an intervention that exercised large-muscle groups, and with a validated outcome measure of cognitive function. First, harms were analyzed. Then a random-effects meta-analysis was completed with subsequent planned subgroup analyses to investigate heterogeneity between CKD stages and treatments, between different exercise types, durations and intensities, and between different outcome methodologies. Finally, quality of evidence was rated. Nineteen trials randomized 1160 participants. Harms were reported on 94 occasions in intervention groups vs. 83 in control. The primary analysis found that exercise had a small but statistically significant effect on cognition in CKD (effect size (ES) = 0.22; 95% confidence intervals (CI95) = 0.00, 0.44; P = 0.05). However, the quality of evidence was rated as low. Subgroup analyses found that type of exercise moderated the effect on cognition (χ2 = 7.62; P = 0.02), with positive effects only observed following aerobic exercise (ES = 0.57; CI95 = 0.21, 0.93; P = 0.002). Across the spectrum of CKD, exercise had a small but positive and clinically meaningful effect on cognitive function and did not appear to be harmful. Aerobic exercise was particularly beneficial. However, results must be interpreted cautiously due to the low quality of evidence. Nevertheless, care teams may choose to recommend aerobic exercise interventions to prevent cognitive decline. Researchers should design unbiased studies to clarify what intensity and duration of exercise is required to maximize efficiency of such exercise interventions.

Is the Epworth Sleepiness scale a valid outcome measure to evaluate the effectiveness of positive airway pressure treatments on daytime sleepiness? Psychometric insights from measurement invariance and response shifts.

Although the validity of the Epworth Sleepiness Scale (ESS) as an effectiveness measure for sleep apnea treatments such as continuous positive airway pressure (CPAP) has been supported by multiple studies, some researchers continue to challenge it. They suggest that in addition to its impact on relieving patients' daytime sleepiness, CPAP also alters the internal standards patients use to evaluate their sleepiness (i.e., response shift; RS), confounding the meaning of the difference in the ESS scores. We believe an issue yet to be addressed in this debate is that all existing evidence of RS has been obtained through the then-test approach, a retrospective method sensitive to various cognitive mechanisms. Thus, in the current study, we re-examined this issue using the structural equation modeling (SEM) approach, a method that can be directly applied to randomized clinical trial (RCT) data without retrospective measures. With the ESS data from two independent RCTs, we conducted cross-sectional and longitudinal measure invariance tests in SEM to examine whether CPAP would lead to RS. The ESS demonstrated cross-sectional and longitudinal scalar invariance against CPAP treatments. Its factorial pattern, loadings, and thresholds were invariant between the treatment and control groups and pre- and post-treatment, supporting the comparability of the observed mean ESS scores across time and groups. Our results support the validity of the average difference scores of the ESS for quantifying the effectiveness of CPAP on group-level daytime sleepiness in RCTs with relatively large sample sizes.