Acceptable Intraclass Correlation Research Articles

Patient-Reported Outcome Measures Used on Patients With Anterior Cruciate Ligament Injury.

Patient-reported knee-related rating scores and scales are widely used in reporting the clinical outcomes of anterior cruciate ligament (ACL) surgery. Understanding the psychometric properties of such measures is vital to recognizing the limitations that such measures may confer. The aim of this study was to review the available evidence as to the psychometric properties of patient-reported outcome measures (PROMs) used in ACL surgery. Eleven studies were identified, the majority being prospective cohort studies. Eight English, ACL-specific patient-reported outcome measures were identified and evaluated: Lysholm score, Tegner Activity Scale (TAS), Cincinnati score, ACL-Quality of Life (QOL) score, International Knee Documentation Committee (IKDC) Subjective Knee Form (SKF), Knee Injury and Osteoarthritis Outcome Score (KOOS)-ACL score, and ACL-Return to Sport Injury (RSI) scale. Only the Lysholm score, ACL-QOL, IKDC SKF, and ACL-RSI were evaluated for internal consistency, having an acceptable Cronbach's α (α>0.70). Most of the scoring systems were assessed for test-retest reliability, with four of them (Lysholm score, TAS, Cincinnati score, and IKDC SKF) having acceptable intraclass correlation coefficient (ICC) values (ICC > 0.70). Criterion validity was assessed for most measures with a good correlation with the IKDC. Effect sizes and standardized response means were large for three instruments that measured responsiveness (Lysholm score, TAS, and Cincinnati score) and moderate for one (ACL-QOL). Evidence is stronger and more robust for the Lysholm score, TAS, ACL-QOL, and IKDC SKF. However, there is variation in their psychometric properties as well as the aspect of knee-related health they are assessing. Hence, none can be universally applicable to all patients with ACL injuries. Recognizing these parameters is vital when choosing which instrument to use in reporting the outcomes of ACL injury or ACL surgery studies.

Validation of an Arabic version of the short form of the health literacy in dentistry scale: a cross-sectional study

BackgroundThe Arabic version of the short form of the Health Literacy in Dentistry scale (HeLD) had not yet been developed in previously published studies. This study aims to test the reliability and validity of an Arabic version of the short form of the HeLD questionnaire.MethodsThe short version of HeLD was translated into Arabic and the psychometric properties were evaluated in a sample of 1,889 female students in their first year of secondary school. Test–retest reliability was assessed using the intra-class correlation coefficient (ICC), and internal consistency reliability was assessed using Cronbach’s alpha. Content validity was investigated by creating a correlation matrix between the individual items of the HeLD-14, and criterion validity was determined using Pearson’s correlation between the HeLD-14 score and an overall oral health rating. Sensitivity analysis was assessed by testing the associations of the HeLD-14 score with oral health-related behaviours and residential area.ResultsThe Arabic version of HeLD-14 (A-HeLD-14) had acceptable ICC (0.54) and excellent internal consistency (Cronbach’s alpha: 0.92). The correlations between the items of the A-HeLD-14 varied from 0.3 to 0.9. The A-HeLD-14 showed a statistically significant correlation with the overall oral health rating (r = 0.37, p < 0.001). The median A-HeLD-14 score was significantly higher in participants who brushed their teeth frequently (51.31), visited the dentist regularly (52.00), consumed fresh fruit frequently (51) and consumed soda or energy drinks infrequently (51.00) than participants who brushed their teeth infrequently (41.50), visited the dentist irregularly (49.00), consumed fresh fruit infrequently (47) and consumed soda or energy drinks frequently (48.00).ConclusionThe A-HeLD-14 instrument demonstrates sufficient validity, reliability, and sensitivity for measuring oral health literacy among the Arabic-speaking population.

Psychometric Properties of the Turkish Adaptation of the Yale Physical Activity Survey.

This study aimed to examine the convergent validity and test-retest reliability of the Turkish version of the Yale Physical Activity Survey (YPAS-TR). Eighty-one volunteer older adults were included in the study. Test-retest reliability was evaluated using the intraclass correlation coefficient. Correlation coefficients between YPAS-TR and Physical Activity Scale for the Elderly (PASE), Short Form-36, and Short Physical Performance Battery were examined for convergent validity. Acceptable intraclass correlation coefficient values were reached for YPAS-TR energy expenditure, total physical activity time and summary, vigorous, leisurely walking, moving, standing, and sitting indices (intraclass correlation coefficient = .96-.99). There was a moderate correlation between energy expenditure and total physical activity time with PASE (leisure time activities), PASE (household activities), and PASE (total) (r = .478, r = .468, r = .570, r = .406, r = .490, r = .550, respectively, p < .001). Also, a weak correlation was found between summary and leisurely walking index with PASE (household activities), standing index with PASE (leisure time activities), and PASE (total) (r = .285, p = .010; r = .257, p = .021; r = .238, p = .033; r = .283, p = .010; respectively). The results of the study suggest that the YPAS-TR is a valid and reliable measurement tool that can be used to assess the physical activity patterns of Turkish older adults.

Cross-cultural adaptation and psychometric properties of the Sinhala version of electronic health literacy scale: A cross-sectional validation study.

eHealth Literacy Scale (eHEALS) is the most widely used, valid and reliable tool to assess eHealth literacy skills, but no culturally appropriate tool exists to assess these skills among Sinhala-speaking Sri Lankans, including health professionals. This study aimed to cross-culturally adapt the original eHEALS from English to Sinhala and evaluate its psychometric properties. The study was conducted in two phases. The first phase involved translation and cross-cultural validation of the questionnaire. The second phase involved a cross-sectional survey conducted online among 268 health science students from a state university in Sri Lanka to confirm the psychometric properties of the questionnaire. An analysis of test-retest reliability was conducted with a subset of 72 students. The pre-final version of Sinhala eHEALS (Si-eHEALS) was developed following the cross-cultural adaptation process. The mean score of Si-eHEALS was 28.51±4.87. A satisfactory level of internal consistency was achieved (Cronbach’s alpha = 0.91). The test-retest reliability was acceptable (intraclass correlation coefficient -.776). Content validity index of Si-eHEALS was.97. The principal component analysis supported the unidimensionality of the scale, explaining 61.2 variance. There was a significant positive association between Si-eHEALS score with academic year (rs = .146, p = .017), self-rated internet skills (rs = .122, p = .046), usefulness of internet in health decision making (rs = .212, p < .001) and importance of ability to access health resources on the internet (rs = .230, p < .001), confirming concurrent validity. No significant difference based on gender (U = 5854, p = .550) and degree program (X2(2) = 2.965, p = .564) was found, confirming discriminant validity. In line with many previous validation studies, our study demonstrated good psychometric properties for Si-eHEALS. Si-eHEALS is a valid and reliable tool that assesses eHealth literacy in Sinhala speaking Sri Lankans, particularly health professionals.

Development of a Comprehensive Battery to Collect Social and Structural Determinants of Health (SSDOH) in Cognitively Normal or Very Mildly Impaired Persons.

Research addressing Alzheimer disease and related dementias must examine nonbiological factors influencing the risk for and expression of Alzheimer disease and related dementias. These factors address the interplay of cognition with lived experiences and social and structural determinants of health (SSDOH). However, coordinated measures of SSDOH are limited. The Knight Alzheimer Disease Research Center (ADRC) at Washington University in St. Louis developed and piloted a comprehensive battery to measure SSDOH. One hundred and twelve participants, very mildly cognitively impaired or unimpaired, enrolled in memory studies completed the electronic SSDOH battery. The Clinical Dementia Rating (CDR) determined the presence or absence of cognitive impairment. Four domains demonstrated above acceptable intraclass correlation scores for test-retest reliability (≥0.70), including adverse childhood events, discrimination, social status, and early education. Twenty very mildly impaired participants completed the electronic pilot study. Our findings indicate that participants with early-stage symptomatic Alzheimer disease are able to participate in electronic SSDOH data collection. In collaboration with the University of Pennsylvania ADRC, we replaced/modified certain assessments to increase intraclass correlation. The resulting battery, Social and Structural Life-courses Influencing Aging and Dementia (SS-DIAD), can serve as a SSDOH collection tool and is currently utilized in cognitively impaired and unimpaired research participants at both ADRCs.

Accuracy of Inflow Inversion Recovery (IFIR) for Upper Abdominal Arteries Evaluation: Comparison with Contrast-Enhanced MR and CTA.

Background: Inflow-sensitive inversion recovery (IFIR) is a recently introduced technique to perform unenhanced magnetic resonance angiography (MRA). The purpose of our study is to determine the accuracy of IFIR-MRA in the evaluation of upper abdominal arteries, compared to standard MRA and computed tomography angiography (CTA). Materials and Methods: Seventy patients undergoing upper abdomen Magnetic Resonance Imaging (MRI) in different clinical settings were enrolled. The MRI protocol included an IFIR-MRA sequence that was intra-individually compared by using a qualitative 4-point scale in the same patients who underwent concomitant or close MRA (n = 65) and/or CTA (n = 44). Celiac trunk (CA), common-proper-left-right hepatic artery (C-P-L-R-HA), left gastric artery (LGA), gastroduodenal artery (GDA), splenic artery (SA), renal arteries (RA) and superior mesenteric artery (SMA) were assessed. Results: IFIR-MRA images were better rated in comparison with MRA. Particularly, all arteries obtained a statistically significant higher qualitative rating value (all p < 0.05). IFIR-MRA and MRA exhibited acceptable intraclass correlation coefficients (ICC) values for CA, C-L-R-HA, and SMA (ICC 0.507, 0.591, 0.615, 0.570, 0.525). IFIR-MRA and CTA showed significant correlations in C-P-L-R-HA (τ = 0.362, 0.261, 0.308, 0.307, respectively; p < 0.05), and in RA (τ = 0.279, p < 0.05). Conclusions: Compared to MRA, IFIR-MRA demonstrated a higher image quality in the majority of upper abdomen arterial vessels assessment. LHA and RHA branches could be better visualized with IFIR sequences, when visualizable. Based on these findings, we suggest to routinely integrate IFIR sequences in upper abdomen MRI studies.

Reliability and validity of the Japanese version of the Pediatric Quality of Life Inventory Infant Scales

BackgroundPedsQL Infant Scales (PedsQL-I) are used to assess parent-reported health-related quality of life for children younger than 2 years. We determined the feasibility, reliability, and validity of the Japanese version of the PedsQL-I.MethodsA total of 183 participants (parents) with infants aged 1–30 months were recruited from 8 day care centers and one pediatric clinic. Participants completed the PedsQL-I (infants aged 1–18 months), the PedsQL-I and the PedsQL-Toddler version (infants aged 19–30 months), and the Kessler-6 psychological distress scale (all participants). We determined feasibility, internal consistency, test–retest reliability, concurrent validity, convergent and discriminant validity, known-groups validity with regard to acute and chronic illness, and relative and transitional validity with PedsQL-Toddler for the use in infants aged 25–30 months.ResultsAll subscales were internally consistent (Cronbach’s alpha for 1–12 months: 0.88–0.98 and for 13–24 months: 0.85–0.97); test–retest reliability was acceptable (intra-class correlation coefficients > 0.40); and all scales were concurrently valid with the PedsQL-Toddler version (Pearson’s product-moment correlation coefficient for the total score = 0.74). The scales’ convergent and discriminant validity were acceptable (scaling success rate > 80%). Validation for known-groups showed that the Physical Health Summary score was sensitive to acute and chronic disease, the Psychosocial Health Summary score was sensitive to neither acute nor chronic disease, and the total score was sensitive to acute disease. Relative validity showed a ratio of 1.74 for the squared t values for the total score.ConclusionsThe PedsQL-I is suitable for assessing health-related quality of life in infants aged 1–24 months in prospective studies.

Interevaluator and Intraevaluator Reliability of Chest Wall Mobility Assessment in Young Asthmatics Subjects

Purpose: To evaluate interrater and intrarater reliability of chest wall mobility using cirtometry in individuals with asthma and controls. Methods: Twenty-six controlled individuals with asthma group (AG) and 12 healthy individuals control group (CG) underwent chest wall mobility assessed by cirtometry. The measurements were performed manually by 2 independent evaluators at 3 levels: axillary, xiphoid and abdominal using a tape, in 2 different days. For the analyses, the average of 3 measurements and the highest value were considered. Results: Interrater reliability in AG showed acceptable intraclass correlation coefficient (ICC) for the axillary (0.76 and 0.75), good for the xiphoid (0.91 and 0.93), and abdominal level (0.91 and 0.91) for the average and highest value. In CG, ICC values were acceptable for the 3 levels: axillary (0.64 and 0.71), xiphoid (0.66 and 0.93), and abdominal level (0.61 and 0.91) also for the average and highest value. The analysis with the mean and the highest values found it acceptable for the axillary and good for the xiphoid and abdominal levels. Intrarater ICC was good for all levels in AG, axillary (0.86), xiphoid (0.93), and abdominal (0.96), for both evaluators. In CG, for evaluator 1, it was acceptable for the axillary and good for the xiphoid and abdominal levels. Regarding evaluator 2, it was good for the axillary and xiphoid and acceptable at the abdominal level. Conclusion: Cirtometry is a reliable tool to measure the chest wall mobility in controlled asthma individuals and in healthy individuals. The average of the 3 measurements or the highest value of the evaluations may be considered in clinical assessments. Axillary mobility was lower in the asthma group.

The geometric features of tibiofemoral joint associated with anterior cruciate ligament injury: Reliability of measurements on conventional MRI

PurposeTo evaluate the measurement reliability of the geometric features of tibiofemoral joint on conventional knee MRI and also identify the features associated with increased risk of ACL injury. MethodsThis retrospective case-control study included knee MRIs of 60 patients with ACL injury (34 men, 26 women; mean age 34 ± 13.6 SD) and 60 normal individuals (31 men, 29 women; mean age 36 ± 11.4 SD). Geometric features of distal femur (intercondylar notch width, transcondylar width, and intercondylar notch angle) and tibial plateau (medial tibial plateau slope, lateral tibial plateau slope, and medial tibial plateau depth) were independently measured by two radiologists for each of the patients. Intraclass correlation coefficient (ICC) values were calculated to assess the reliability of the measurements. Variables with acceptable ICC values were included in the final logistic regression model, but the remaining were only reported descriptively. ResultsThere was good to excellent agreement between the radiologist in the measurement of ICNW and TCW. However, the agreement between the radiologists was not acceptable for the rest of the variables. The univariate logistic regression model showed as ICNW decreases, the risk of ACL injury increases (OR = 0.12, 95% CI [0.02, 0.60], p = 0.01). ConclusionsOur results suggest that ICNW and TCW are the only geometric features of the tibiofemoral joint that can be reliably measured on conventional knee MRI. Moreover, decreased ICNW is associated with an increased risk of ACL injury.

Reliability of Smartphone Applications for the Quantification of Oxygen Saturation.

BackgroundSmartphone technology is rapidly evolving and advancing, with many of them offering health applications being used for oximetry purposes, including the Samsung Health/S Health application. Measuring oxygen saturation is one of the important indications to monitor patients with COVID-19, as well as other health conditions. These applications can be used for measuring oxygen saturation to provide a convenient solution for clinical decisions.MethodsOxygen saturation measurements were collected using the Samsung Health application for Samsung Galaxy smartphone with a sensor and camera flash and a low-cost portable digital display (liquid crystal display (LCD)) finger pulse oximeter. Intra-session reliability was established to determine the consistency between the measures. Intra-class correlation coefficients (ICCs) were calculated with 95% confidence intervals (CIs) reported for both methods. The Bland-Altman plot was used to compare the level of agreement between the two measurement methods.ResultsThere was a statistically significant average difference between pulse oximeter and Samsung Health application measurements (t125 = 4.407, p < 0.001), and on average, pulse oximeter measurement was 0.510 points higher than Samsung Health application measurement (95% CI = 0.281-0.740). The pulse oximeter and Samsung Health application scores were moderately correlated (r = 0.462). The results of the intra-session reliability test produced an acceptable ICC value of 0.557, indicating moderate reliability and consistent results for the measurement of oxygen saturation with both methods. The Bland-Altman plot showed a consistently equal distribution of data points scattered above and below zero.ConclusionSmartphone health applications can be used with moderate reliability to measure oxygen saturation.

Infant with Clefts Observation Outcomes Instrument (iCOO): A New Outcome for Infants and Young Children with Orofacial Clefts.

We evaluated the measurement properties for item and domain scores of the Infant with Clefts Observation Outcomes Instrument (iCOO). Cross-sectional (before lip surgery) and longitudinal study (preoperative baseline and 2 days and 2 months after lip surgery). Three academic craniofacial centers and national online advertisements. Primary caregivers with an infant with cleft lip with or without cleft palate (CL ± P) scheduled to undergo primary lip repair. There were 133 primary caregivers at baseline, 115 at 2 days postsurgery, and 112 at 2 months postsurgery. Caregiver observation items (n = 61) and global impression of health and function items (n = 8) across eight health domains. Mean age at surgery was 6.0 months (range 2.7-11.8 months). Five of eight iCOO domains have scale scores, with Cronbach's alphas ranging from 0.67 to 0.87. Except for the Facial Skin and Mouth domain, iCOO scales had acceptable intraclass correlation coefficients (ICCs) ranging from 0.76 to 0.84. The internal consistency of the Global Impression items across all domains was 0.90 and had acceptable ICCs (range 0.76-0.91). Sixteen out of 20 (nonscale) items had acceptable ICCs (range 0.66-0.96). As anticipated, iCOO scores 2 days postoperatively were generally lower than baseline and scores 2 months postsurgery were consistent with baseline or higher. The iCOO took approximately 10 min to complete. The iCOO meets measurement standards and may be used for assessing the impact of cleft-related treatments in clinical research and care. More research is needed on its use in various treatment contexts.

Discrepancies between self-reported and device-measured sleep parameters in adults with multiple sclerosis.

Sleep problems are a common consequence of multiple sclerosis; however, there is limited evidence regarding the agreement between device-measured and self-reported sleep parameters in adults with multiple sclerosis. The present study examined the agreement between self-reported and device-measured parameters of sleep quality in a sample of adults with multiple sclerosis. Participants (n = 49) completed a 7-day sleep diary and wore a wrist-worn ActiGraph GT3×+ (ActiGraph Corp., Pensecola, FL) for seven consecutive nights to quantify self-reported and device-measured sleep parameters, respectively. There was a significant discrepancy between self-reported and device-measured parameters of total time in bed (mean difference = 19.8 [51.3] min), sleep onset latency (mean difference = 22.2 [19.5] min), and frequency of awakenings during the night (mean difference = 12.8 [6.8]). Intraclass correlation estimates indicated poor agreement between methods on most parameters, except for total time in bed (intraclass correlation = 0.80). Bland-Altman plots suggested that total time in bed and total sleep time had acceptable levels of agreement and linear regression analyses indicated that sleep onset latency (F = 113.91, B = -1.34, P < .001), number of awakenings (F = 543.34, B = 1.85, P < .001), and sleep efficiency (F = 18.39, B = -0.77, P < .001) had significant proportional bias. Our results draw attention to the discrepancies between sleep parameter measurements and highlight the importance of including both self-report and device-measured outcomes for a complete and accurate representation of sleep in adults with multiple sclerosis. Cederberg KLJ, Mathison BG, Schuetz ML, Motl RW. Discrepancies between self-reported and device-measured sleep parameters in adults with multiple sclerosis. J Clin Sleep Med. 2022;18(2):415-421.

Psychometric properties of the Food Environment Assessment Survey Tool (FEAST) in people with mobility impairment.

Approximately one in ten adults under the age of 65 in the USA has a mobility impairing disability. People with mobility impairment generally have poorer dietary habits contributing to obesity and related negative health outcomes. This article presents the psychometric properties of the Food Environment Assessment Survey Tool (FEAST) instrument that measures barriers to accessing healthy food from the perspective of people with mobility impairment (PMI). The current study presents cross-sectional data from two sequential independent surveys. Surveys were administered online to a national sample of PMI. Participants represented PMI living throughout the USA. The pilot FEAST survey involved 681 participants and was used to shape the final instrument; 25 % completed a retest survey. After following empirically and theoretically guided item reduction strategies, the final FEAST instrument was administered to a separate sample of 304 PMI. The final twenty-seven-item FEAST instrument includes items measuring Neighbourhood Environment, Home Environment, Personal Control and Access to Support (Having Help, Food Delivery Services, Parking/Transportation). The final four scales had acceptable intra-class correlations, indicating that the scales could be used as reliable measures of the hypothesised constructs in future studies. The FEAST instrument is the first of its kind developed to assess the food environment from the perspective of PMI themselves. Future studies would benefit from using this measure in research and practice to help guide the development of policy aimed at improving access to healthy food and promoting healthy eating in community-dwelling PMI.

Test–retest reliability of the Turkish translation of the Penn Computerized Neurocognitive Battery

Psychiatric disorders are associated with cognitive dysfunction (CD), and reliable screening and follow-up of CD is essential both for research and clinical practice globally; yet, most assessments are in Western languages. We aimed to evaluate the test–retest reliability of the Turkish version of the Penn Computerized Neurocognitive Battery (PennCNB) to guide confident interpretation of results. Fifty-eight healthy individuals completed the PennCNB Turkish version in two sessions. After quality control, reliability analysis was conducted using Intraclass Correlation Coefficients (ICC), corrected for practice effects. Most measures were not significantly different between the sessions and had acceptable ICC values, with several exceptions. Scores were improved considerably for some memory measures, including immediate Facial Memory and Spatial Memory, and for incorrect responses in abstraction and mental flexibility, with correspondingly acceptable ICCs. Test–retest assessment of the Turkish version of the PennCNB shows that it can be used as a reliable real-time measurement of cognitive function in snapshot cross-sectional or longitudinal determinations. Preliminary validity assessment in this normative sample showed expected positive correlations with education level and negative correlations with age. Thus, the Turkish version of the PennCNB can be considered a reliable neuropsychological testing tool in research and clinical practice. Practice effects should be considered, especially when applied in short intervals. Significantly better performances in the retest, beyond practice effect, likely reflect nonlinear improvements in some participants who “learned how to learn” the memory tests or had insight on solving the abstraction and mental flexibility test.

Psychometric properties of the critical thinking disposition assessment test amongst medical students in China: a cross-sectional study

BackgroundCritical thinking disposition helps medical students and professionals overcome the effects of personal values and beliefs when exercising clinical judgment. The lack of effective instruments to measure critical thinking disposition in medical students has become an obstacle for training and evaluating students in undergraduate programs in China. The aim of this study was to evaluate the psychometric properties of the CTDA test.MethodsA total of 278 students participated in this study and responded to the CTDA test. Cronbach’s α coefficient, internal consistency, test-retest reliability, floor effects and ceiling effects were measured to assess the reliability of the questionnaire. Construct validity of the pre-specified three-domain structure of the CTDA was evaluated by explanatory factor analysis (EFA) and confirmatory factor analysis (CFA). The convergent validity and discriminant validity were also analyzed.ResultsCronbach’s alpha coefficient for the entire questionnaire was calculated to be 0.92, all of the domains showed acceptable internal consistency (0.81–0.86), and the test-retest reliability indicated acceptable intra-class correlation coefficients (ICCs) (0.93, p < 0.01). The EFA and the CFA demonstrated that the three-domain model fitted the data adequately. The test showed satisfactory convergent and discriminant validity.ConclusionsThe CTDA is a reliable and valid questionnaire to evaluate the disposition of medical students towards critical thinking in China and can reasonably be applied in critical thinking programs and medical education research.

Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies

BackgroundTo evaluate the psychometric and measurement properties of two patient-reported outcome instruments, the menstrual pictogram superabsorbent polymer-containing version 3 (MP SAP-c v3) and Uterine Fibroid Daily Bleeding Diary (UF-DBD).Test-retest reliability, criterion, construct validity, responsiveness, missingness and comparability of the MP SAP-c v3 and UF-DBD versus the alkaline hematin (AH) method and a patient global impression of severity (PGI-S) were analyzed in post hoc trial analyses.ResultsAnalyses were based on data from up to 756 patients. The full range of MP SAP-c v3 and UF-DBD response options were used, with score distributions reflecting the cyclic character of the disease. Test-retest reliability of MP SAP-c v3 and UF-DBD scores was supported by acceptable intraclass correlation coefficients when stability was defined by the AH method and Patient Global Impression of Severity (PGI-S) scores (0.80–0.96 and 0.42–0.94, respectively). MP SAP-c v3 and UF-DBD scores demonstrated strong and moderate-to-strong correlations with menstrual blood loss assessed by the AH method. Scores increased in monotonic fashion, with greater disease severities, defined by the AH method and PGI-S scores; differences between groups were mostly statistically significant (P < 0.05). MP SAP-c v3 and UF-DBD were sensitive to changes in disease severity, defined by the AH method and PGI-S. MP SAP-c v3 and UF-DBD showed a lower frequency of missing patient data versus the AH method, and good agreement with the AH method.ConclusionsThis evidence supports the use of the MP SAP-c v3 and UF-DBD to assess clinical efficacy endpoints in UF phase III studies replacing the AH method.

Venous blood gas parameters, electrolytes, glucose and lactate concentration in sick neonatal foals: Direct venipuncture versus push-pull technique.

Blood collection by indwelling intravenous catheter (IVC) avoids repeated venipuncture, which could cause thrombophlebitis risk, anxiety and pain in patients. To compare blood gas parameters, electrolytes, glucose, lactate and haematocrit concentration obtained from venous blood samples collected via a jugular IVC by push-pull (PP) technique to those obtained by venipuncture in hospitalised foals, at the time of catheter placement (T0) and 24hours after the beginning of intravenous therapy (T24). Prospective observational study. Paired blood samples were drawn from hospitalised foals at T0 and T24. In each foal, one venous blood sample was collected via IVC by the following PP technique: 2.4mL of blood was aspirated and immediately reinfused through the catheter three times consecutively, then 1mL of blood was collected using a 1mL heparinised syringe. Thereafter, another sample was collected by direct venipuncture of the contralateral jugular vein, with an identical 1mL heparinised syringe, with a 1-inch, 20-G needle. All samples were analysed with an automated blood gas analyser within 10minutes of collection. The agreement between the two techniques was assessed by Bland-Altman analysis and intraclass correlation coefficient (ICC). The level of agreement of blood gas values obtained by the two different techniques was high with very small bias and clinically acceptable ICC (>0.907 at T0; >0.794 at T24) for all variables, except for haematocrit (bias -3.52 at T0; -2.44 at T24) and PvO2 at T0 and T24 (ICC 0.669 and 0.733, respectively). Potential sub-clinical catheter-related complications were not investigated by ultrasound or bacterial culture of the catheter; short duration of the study. PP technique appears to be acceptable for collection of blood samples for venous blood gas parameters, as well as electrolytes, glucose and lactate in sick neonatal foals.

Validation study of the Japanese version of MD Anderson Symptom Inventory for Brain Tumor module.

The MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) module is a widely used instrument for measuring symptom burden and interference of daily activities in brain tumor patients. This study aims to develop and validate its Japanese version (MDASI-BT-Japanese). Following forward and backward translation of the original MDASI-BT into Japanese, understandability and feasibility were assessed by cognitive debriefing. Subsequently, patients with brain tumors were asked to fill out MDASI-BT-Japanese and European Quality of Life-5 Dimensions (EQ-5D). Feasibility, reliability and validity of MDASI-BT-Japanese were assessed. Cognitive debriefing confirmed overall ease of completion and good understandability. The study population composed of 140 patients with brain tumors (most commonly gliomas). The mean symptom severity score and mean interference score were 1.9±1.7 and 2.8±2.7, respectively. The top items included distress and drowsiness for symptom severity and general activity and work for interference. The median time required was 4minutes (range, 0.5-30), and missing values were seen in 1%. Internal consistency was proven by excellent Cronbach's coefficient alpha (0.94 for symptom severity, 0.92 for interference). Test-retest reliability was assessed with acceptable intra-class correlation coefficient (mean, 0.76). Correlation efficient ranged between 0.7 and 0.9 for convergent validity. Known-group validity was confirmed by significantly different mean symptom severity score and mean interference score among patients with different performance status. As evidence of concurrent validity, MDASI-BT-Japanese correlated with EQ-5D in the hypothesized magnitude and direction. The newly developed MDASI-BT-Japanese has demonstrated feasibility, reliability and validity in evaluation of clinical benefit in Japanese-speaking brain tumor patients.

Spondyloarthritis Research Consortium of Canada sacroiliac joint inflammation and structural scores: change score reliability and recalibration utility in children

BackgroundThe SPARCC sacroiliac joint inflammation (SIS) and structural (SSS) scores are reliable measures to quantify abnormalities in the pediatric sacroiliac joint. We aimed to evaluate the utility of online calibration modules for the SIS and SSS and the reliability of their component change scores.MethodsChange score reliability of 6 raters was assessed by overall and pairwise intraclass correlation coefficients (ICCs) before and after the use of real-time iterative calibration (RETIC) modules for both the SIS and SSS comprised of 20 adult cases. Acceptable ICC for change scores was > 0.7 for SIS and > 0.5 for all SSS components. Sensitivity to change was assessed by the standardized response mean (SRM).ResultsIn scoring exercise 1, the SIS had acceptable reliability with a change score ICC of 0.80 and sclerosis was the only SSS lesion that met the acceptability threshold with a change score ICC of 0.52. After RETIC calibration, the SIS overall (ICC = 0.83) and mean pairwise (ICC = 0.83) change scores remained reliable with a large SRM (0.90). All SSS components except sclerosis met the overall and mean pairwise change score ICC acceptability thresholds—backfill: overall = 0.54, mean pairwise = 0.50; fat metaplasia: overall = 0.65, mean pairwise = 0.57; erosion: overall = 0.60, mean pairwise = 0.58; and ankylosis: overall = 0.96, mean pairwise = 0.96. The SSS RETIC module augmented the number of SSS components surpassing the acceptability threshold from 1 to 4. Sensitivity to change, as measured by the SRM, was large for erosion (0.96), moderate for backfill (0.55) and sclerosis (0.70), and small for fat metaplasia (0.36) and ankylosis (0.28).ConclusionRETIC modules improved the overall reliability of SPARCC SIS and SSS change scores for previously calibrated raters. SIS recalibration was not as helpful to the most experienced raters who achieved high levels of agreement before recalibration. The SPARCC SIS and all SSS components except sclerosis are reliable measures to quantify change over time in children. A pediatric-specific RETIC tool should be developed to enhance the calibration of readers.

Development and initial validation of an electronic personal assessment questionnaire for menstrual, pelvic pain and gynaecological hormonal disorders (ePAQ-MPH)

ObjectiveMenstrual disorders, pelvic-pain and gynaecological hormonal conditions in women can have a significant impact on quality-of-life. Reliable assessment and monitoring of these intimate conditions is challenging. Patient reported outcome measures (PROMs) can be invaluable in providing objective assessment, but no comprehensive PROM assessing all of these conditions and their impact on quality of life is currently available. The purpose of this study was to develop and undertake initial psychometric testing of a comprehensive interactive electronic patient reported outcome measure for these conditions. Study designA prototype electronic PROM (ePAQ-MPH) was developed following systematic literature review, semi structured interviews with 25 patients and expert panel review. Exploratory factor analysis was undertaken in 291 women attending a menstrual-disorders clinic; establishing a domain structure and enabling item reduction. Two validated PROMS (Women’s Health Questionnaire and Menstrual Distress Questionnaire) were completed to assess criterion validity in 213 patients. Test-retest reliability was carried out in 30 women completing ePAQ-MPH at least one week apart. Patients' views on ‘Value’ and ‘Burden’ were assessed in 278 women using a validated 10-item survey measuring questionnaire utility (QQ-10). Confirmatory factor analysis (CFA) of the revised version of ePAQ-MPH following item reduction was undertaken in a different sample of 254 women. ResultsExploratory factor analysis identified 18 domains (Cronbach’s α > 0.7) and 30 redundant items. Test-retest analysis found acceptable intra-class correlations of 0.6–0.9 (p < 0.05). Eight domains were compared with Menstrual Distress Questionnaire showing moderate or strong correlation in seven domains. Ten domains were compared with Women’s Health Questionnaire, six of which showed moderate correlation. Mean QQ-10 Value and Burden scores were 76 and 25, respectively (SD=15.8 and 15.5). The mean completion time for ePAQ-MPH was 31 min. CFA of the revised version 2 instrument with 15 domains showed good model fit. ConclusionsWhilst wider psychometric testing of the revised version of ePAQ-MPH is required, including in different settings and in assessments of data quality and responsiveness, initial analysis provides some evidence for reliability, validity and acceptability of this multi-dimensional electronic PROM. ePAQ-MPH shows potential for both patient assessment and roles in service evaluation and research.