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

2021 ◽  
pp. 105566562110403
Author(s):  
Todd C. Edwards ◽  
Carrie L. Heike ◽  
Kathleen A. Kapp-Simon ◽  
Salene M. Jones ◽  
Brian G. Leroux ◽  
...  

Objective We evaluated the measurement properties for item and domain scores of the Infant with Clefts Observation Outcomes Instrument (iCOO). Design Cross-sectional (before lip surgery) and longitudinal study (preoperative baseline and 2 days and 2 months after lip surgery). Setting Three academic craniofacial centers and national online advertisements. Participants 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. Main Outcome Measure(s) Caregiver observation items ( n = 61) and global impression of health and function items ( n = 8) across eight health domains. Results 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. Conclusions 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.

2018 ◽  
Vol 77 (9) ◽  
pp. 1311-1317 ◽  
Author(s):  
Uta Kiltz ◽  
Désirée van der Heijde ◽  
Annelies Boonen ◽  
Nurullah Akkoc ◽  
Wilson Bautista-Molano ◽  
...  

ObjectivesTo evaluate construct validity, interpretability, reliability and responsiveness as well as determination of cut-off points for good and poor health within the original English version and the 18 translations of the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI) in 23 countries worldwide in patients with spondyloarthritis (SpA).MethodsA representative sample of patients with SpA fulfilling the ASAS classification criteria for axial (axSpA) or peripheral SpA was used. The construct validity of the ASAS HI was tested using Spearman correlation with several standard health outcomes for axSpA. Test–retest reliability was assessed by intraclass correlation coefficients (ICCs) in patients with stable disease (interval 4–7 days). In patients who required an escalation of therapy because of high disease activity, responsiveness was tested after 2–24weeks using standardised response mean (SRM).ResultsAmong the 1548 patients, 64.9% were men, with a mean (SD) age 42.0 (13.4) years. Construct validity ranged from low (age: 0.10) to high (Bath AnkylosingSpondylitisFunctioning Index: 0.71). Internal consistency was high (Cronbach’s α of 0.93). The reliability among 578 patients was good (ICC=0.87 (95% CI 0.84 to 0.89)). Responsiveness among 246 patients was moderate-large (SRM=−0.44 for non-steroidal anti-inflammatory drugs, −0.69 for conventional synthetic disease-modifying antirheumatic drug and −0.85 for tumour necrosis factor inhibitor). The smallest detectable change was 3.0. Values ≤5.0 have balanced specificity to distinguish good health as opposed to moderate health, and values ≥12.0 are specific to represent poor health as opposed to moderate health.ConclusionsThe ASAS HI proved to be valid, reliable and responsive. It can be used to evaluate the impact of SpA and its treatment on functioning and health. Furthermore, comparison of disease impact between populations is possible.


2016 ◽  
Vol 10 (1) ◽  
pp. 190-205 ◽  
Author(s):  
Siamak Bashardoust Tajali ◽  
Joy C. MacDermid ◽  
Ruby Grewal ◽  
Chris Young

Study Design: Cross-sectional reliability and validity study. Purpose: 1. To determine intrarater, interrater and inter instrument reliabilities and validity of two digital electro goniometry to measure active wrist/finger range of motions (ROMs) in patients with limited motion. 2. To determine intrarater and interrater reliabilities of digital goniometry to measure torques of PIP passive flexion of the index finger in patients with limited motion. Methods: The study was designed in a randomized block plan on 44 patients (24 women, 20 men) with limited wrist or hand motions. Two experienced raters measured active wrist ROMs, and active and passive index PIP flexion using two digital goniometers. All measures were repeated by one rater 2-5 days after the initial measurements. The reliability measures were analyzed using Intraclass Correlation Coefficients (ICCs) and the construct validity was determined by correlation coefficients analysis between sub measures of scores; patient rated pain and function (PRWE) and quick Disabilities of the Arm, Shoulder and Hand (quick DASH) scores. Results: The intrarater, interrater and inter instrument reliabilities were high in most ROM measures (range 0.64-0.97) for both types of electro-goniometers. The 95% limit of agreements and Bland and Altman plots did not show progressive changes. There was a significant difference in force application between the raters when performing passive ROM measures for PIP index, but the same rater produced consistent force. Most of the NK and J-Tech ROM measures were moderately correlated with the patient rated pain and function scores (range 0.32-0.63).


Author(s):  
Alex Bató ◽  
Valentin Brodszky ◽  
L. Hunor Gergely ◽  
Krisztián Gáspár ◽  
Norbert Wikonkál ◽  
...  

Abstract Purpose Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that affects up to 1% of the population in Europe. The EQ-5D is the most commonly used generic instrument for measuring health-related quality of life among HS patients. This study aims to compare the measurement properties of the two adult versions of EQ-5D (EQ-5D-3L and EQ-5D-5L) in patients with HS. Methods We recruited 200 consecutive patients with HS (mean age 37 years, 38% severe or very severe HS) to participate in a multicentre cross-sectional survey. Patients completed the EQ-5D-3L, EQ-5D-5L, Dermatology Life Quality Index (DLQI) and Skindex-16 questionnaires. Results More than twice as many different health state profiles occurred in the EQ-5D-5L compared to the EQ-5D-3L (101 vs. 43). A significant reduction in ceiling effect was found for the mobility, self-care and usual activities dimensions. A good agreement was established between the EQ-5D-3L and EQ-5D-5L with an intraclass correlation coefficient of 0.872 (95% CI 0.830–0.903; p < 0.001) that was confirmed by a Bland-Altman plot. EQ-5D-5L improved both the absolute and relative informativity in all dimensions except for anxiety/depression. EQ-5D-3L and EQ-5D-5L demonstrated similar convergent validity with DLQI and Skindex-16. EQ-5D-5L was able to better discriminate between known groups of patients based on the number of comorbidities and disease severity (HS-Physician's Global Assessment). Conclusion In patients with HS, the EQ-5D-5L outperformed the EQ-5D-3L in feasibility, ceiling effects, informativity and known-groups validity for many important clinical characteristics. We recommend using the EQ-5D-5L in HS patients across various settings, including clinical care, research and economic evaluations.


2021 ◽  
Vol 10 (5) ◽  
pp. 937
Author(s):  
Gauri Bapayeva ◽  
Gulzhanat Aimagambetova ◽  
Alpamys Issanov ◽  
Sanja Terzic ◽  
Talshyn Ukybassova ◽  
...  

Although it is clear that infertility leads to heightened stress for patients, the impact of depressed mood and anxiety on treatment outcome is inconsistently reported. The aim of this study was to evaluate the effect of stress, depression and anxiety on in vitro fertilization (IVF) outcomes in Kazakhstani public assisted reproductive technology (ART) clinics. The prospective cohort study was performed between June 2019 and September 2020 using questionnaires to assess psychological stress, depressed mood and anxiety in women referred to IVF clinics in two public clinical centers in Kazakhstan, Nur-Sultan and Aktobe. Our study sample comprised 142 women with the average age of 33.9 ± 4.9 years, and infertility duration 6.0 ± 3.5 years. More than half of respondents had Center for Epidemiological Studies Depression Scale (CES-D) scores higher than 16, indicating their risk of developing clinical depression. Ninety-one percent of women from Aktobe city were at risk for clinical depression (p < 0.001). Aktobe city respondents had higher stress subscale scores and anxiety scale scores (p < 0.001) than Nur-Sultan respondents. Statistical analysis showed that IVF outcome was not significantly associated with depression and stress, while the higher anxiety scale scores were negatively associated with clinical pregnancy after IVF.


Biomolecules ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. 295
Author(s):  
Kjersti Sletten Bakken ◽  
Ingvild Oma ◽  
Synne Groufh-Jacobsen ◽  
Beate Stokke Solvik ◽  
Lise Mette Mosand ◽  
...  

Mild to moderate iodine deficiency is common among women of childbearing age. Data on iodine status in infants are sparse, partly due to the challenges in collecting urine. Urinary iodine concentration (UIC) is considered a good marker for recent dietary iodine intake and status in populations. The aim of this study was to investigate the reliability of iodine concentration measured in two spot-samples from the same day of diaper-retrieved infant urine and in their mothers’ breastmilk. We collected urine and breastmilk from a sample of 27 infants and 25 mothers participating in a cross-sectional study at two public healthcare clinics in Norway. The reliability of iodine concentration was assessed by calculating the intraclass correlation coefficients (ICC) and the coefficient of variation (CV). The ICC for infants’ urine was 0.64 (95% confidence interval (CI) 0.36–0.82), while the ICC for breastmilk was 0.83 (95% CI 0.65–0.92) Similarly, the intraindividual CV for UIC was 0.25 and 0.14 for breastmilk iodine concentration (BIC). Compared to standard methods of collecting urine for measuring iodine concentration, the diaper-pad collection method does not substantially affect the reliability of the measurements.


2020 ◽  
Author(s):  
David Høyrup Christiansen ◽  
Gareth McCray ◽  
Trine Nøhr Winding ◽  
Johan Hviid Andersen ◽  
Kent Jacob Nielsen ◽  
...  

Abstract Background: The Musculoskeletal Health Questionnaire (MSK-HQ) has been developed to measure musculoskeletal health status across musculoskeletal conditions and settings. However, the MSK-HQ needs to be further evaluated across settings and different languages.Objective: The objective of the study was to evaluate and compare measurement properties of the MSK-HQ across Danish (DK) and English (UK) cohorts of patients from primary care physiotherapy services with musculoskeletal pain. Methods: MSK-HQ was translated into Danish according to international guidelines. Measurement invariance was assessed by differential item functioning (DIF) analyses. Test-retest reliability, measurement error, responsiveness and minimal clinically important change (MCIC) were evaluated and compared between DK (n=153) and UK (n=166) cohorts. Results: The Danish version demonstrated acceptable face and construct validity. Out of the 14 MSK-HQ items, three items showed DIF for language (pain/stiffness at night, understanding condition and confidence in managing symptoms) and three items showed DIF for pain location (walking, washing/dressing and physical activity levels). Intraclass Correlation Coefficients for test-retest were 0.86 (95% CI 0.81 to 0.91) for DK cohort and 0.77 (95% CI 0.49 to 0.90) for the UK cohort. The systematic measurement error was 1.6 and 3.9 points for the DK and UK cohorts respectively, with random measurement error being 8.6 and 9.9 points. Receiver operating characteristic (ROC) curves of the change scores against patients’ own judgment at 3 months exceeded 0.70 in both cohorts. Absolute and relative MCIC estimates were 8-10 points and 26% for the DK cohort and 6-8 points and 29% for the UK cohort.Conclusions: The measurement properties of MSK-HQ were acceptable across countries, but seem more suited for group than individual level evaluation. Researchers and clinicians should be aware that some discrepancy exits and should take the observed measurement error into account when evaluating change in scores over time.


2021 ◽  
Vol 8 ◽  
Author(s):  
Yunru Liao ◽  
Zhenlan Yang ◽  
Zijing Li ◽  
Rui Zeng ◽  
Jing Wang ◽  
...  

Purpose: Purpose of this study is to evaluate the measuring consistency of central refraction between multispectral refraction topography (MRT) and autorefractometry.Methods: This was a descriptive cross-sectional study including subjects in Sun Yat-sen Memorial Hospital from September 1, 2020, to December 31, 2020, ages 20 to 35 years with a best corrected visual acuity of 20/20 or better. All patients underwent cycloplegia, and the refractive status was estimated with autorefractometer, experienced optometrist and MRT. We analyzed the central refraction of the autorefractometer and MRT. The repeatability and reproducibility of values measured using both devices were evaluated using intraclass correlation coefficients (ICCs).Results: A total of 145 subjects ages 20 to 35 (290 eyes) were enrolled. The mean central refraction of the autorefractometer was −4.69 ± 2.64 diopters (D) (range −9.50 to +4.75 D), while the mean central refraction of MRT was −4.49 ± 2.61 diopters (D) (range −8.79 to +5.02 D). Pearson correlation analysis revealed a high correlation between the two devices. The intraclass correlation coefficient (ICC) also showed high agreement. The intrarater and interrater ICC values of central refraction were more than 0.90 in both devices and conditions. At the same time, the mean central refraction of experienced optometrist was −4.74 ± 2.66 diopters (D) (range −9.50 to +4.75D). The intra-class correlation coefficient of central refraction measured by MRT and subjective refraction was 0.939.Conclusions: Results revealed that autorefractometry, experienced optometrist and MRT show high agreement in measuring central refraction. MRT could provide a potential objective method to assess peripheral refraction.


10.2196/20172 ◽  
2021 ◽  
Vol 4 (1) ◽  
pp. e20172
Author(s):  
Masanori Tanaka ◽  
Manabu Saito ◽  
Michio Takahashi ◽  
Masaki Adachi ◽  
Kazuhiko Nakamura

Background Early detection and intervention for neurodevelopmental disorders are effective. Several types of paper questionnaires have been developed to assess these conditions in early childhood; however, the psychometric equivalence between the web-based and the paper versions of these questionnaires is unknown. Objective This study examined the interformat reliability of the web-based parent-rated version of the Autism Spectrum Screening Questionnaire (ASSQ), Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS), Developmental Coordination Disorder Questionnaire 2007 (DCDQ), and Strengths and Difficulties Questionnaire (SDQ) among Japanese preschoolers in a community developmental health check-up setting. Methods A set of paper-based questionnaires were distributed for voluntary completion to parents of children aged 5 years. The package of the paper format questionnaires included the ASSQ, ADHD-RS, DCDQ, parent-reported SDQ (P-SDQ), and several additional demographic questions. Responses were received from 508 parents of children who agreed to participate in the study. After 3 months, 300 parents, who were among the initial responders, were randomly selected and asked to complete the web-based versions of these questionnaires. A total of 140 parents replied to the web-based format and were included as a final sample in this study. Results We obtained the McDonald ω coefficients for both the web-based and paper formats of the ASSQ (web-based: ω=.90; paper: ω=.86), ADHD-RS total and subscales (web-based: ω=.88-.94; paper: ω=.87-.93), DCDQ total and subscales (web-based: ω=.82-.94; paper: ω=.74-.92), and P-SDQ total and subscales (web-based: ω=.55-.81; paper: ω=.52-.80). The intraclass correlation coefficients between the web-based and paper formats were all significant at the 99.9% confidence level: ASSQ (r=0.66, P<.001); ADHD-RS total and subscales (r=0.66-0.74, P<.001); DCDQ total and subscales (r=0.66-0.71, P<.001); P-SDQ Total Difficulties and subscales (r=0.55-0.73, P<.001). There were no significant differences between the web-based and paper formats for total mean score of the ASSQ (P=.76), total (P=.12) and subscale (P=.11-.47) mean scores of DCDQ, and the P-SDQ Total Difficulties mean score (P=.20) and mean subscale scores (P=.28-.79). Although significant differences were found between the web-based and paper formats for mean ADHD-RS scores (total: t132=2.83, P=.005; Inattention subscale: t133=2.15, P=.03; Hyperactivity/Impulsivity subscale: t133=3.21, P=.002), the effect sizes were small (Cohen d=0.18-0.22). Conclusions These results suggest that the web-based versions of the ASSQ, ADHD-RS, DCDQ, and P-SDQ were equivalent, with the same level of internal consistency and intrarater reliability as the paper versions, indicating the applicability of the web-based versions of these questionnaires for assessing neurodevelopmental disorders.


2019 ◽  
Vol 57 (2) ◽  
pp. 169-176
Author(s):  
Anna Lena Sundell ◽  
Anna-Karin Nilsson ◽  
Agneta Marcusson ◽  
Carl-Johan Törnhage

Objective: Data on the association between body mass index (BMI) and dental caries in children with orofacial clefts are sparse. Therefore, studies on the impact of BMI on caries frequency in children with cleft lip and/or palate (CL/P) are of importance. The aim of the current study was to investigate the association between BMI and frequency of dental caries in children with and without CL/P. Height, weight, and BMI in children with CL/P were also compared to controls. Design: This study used a cross-sectional case-control design. Participants: One hundred and thirty-nine 5- and 10-year-old children with CL/P and 299 age-matched controls. Main Outcome Measures: Caries was recorded according to the International Caries Detection and Assessment System. Height and weight were recorded, and BMI was calculated as weight/height2. Results: There was no correlation between BMI and caries frequency. Weight, height, and BMI were significantly lower in all children with CL/P compared to controls. After adjustment for international adoption, only BMI was significantly lower in CL/P children compared to controls. Non-adopted children with CL/P were significantly heavier and longer than adopted children with CL/P. Conclusions: Five- and 10-year-old children with corrected CL/P seemed to have a lower BMI than controls, but there was no association between BMI and caries frequency. Internationally adopted children with CL/P were lighter and shorter than non-adopted CL/P children and controls.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Gabriel N. Valbuena ◽  
Sophia Apostolidou ◽  
Rhiannon Roberts ◽  
Julie Barnes ◽  
Wendy Alderton ◽  
...  

Abstract Understanding the normal temporal variation of serum molecules is a critical factor for identifying useful candidate biomarkers for the diagnosis and prognosis of chronic disease. Using small RNA sequencing in a longitudinal study of 66 women with no history of cancer, we determined the distribution and dynamics (via intraclass correlation coefficients, ICCs) of the miRNA profile over 3 time points sampled across 2–5 years in the course of the screening trial, UKCTOCS. We were able to define a subset of longitudinally stable miRNAs (ICC >0.75) that were individually discriminating of women who had no cancer over the study period. These miRNAs were dominated by those originating from the C14MC cluster that is subject to maternal imprinting. This assessment was not significantly affected by common confounders such as age, BMI or time to centrifugation nor alternative methods to data normalisation. Our analysis provides important benchmark data supporting the development of miRNA biomarkers for the impact of life-course exposure as well as diagnosis and prognostication of chronic disease.


Sign in / Sign up

Export Citation Format

Share Document