Intraclass Correlation Coefficient Scores Research Articles

Talocalcaneal Tarsal Coalition Size: Evaluation and Reproducibility of MRI Measurements.

The size of talocalcaneal tarsal coalitions (TCCs) is one of the main factors that is thought to influence patient outcomes after resection. Magnetic resonance imaging (MRI) is increasingly being used to diagnose and characterize TCCs. However, there is no reproducible MRI-based measurement of TCC size reported in the literature. The purpose of this study was to create a method to reproducibly measure TCC size using MRI. Twenty-seven patients with TCCs diagnosed by a hindfoot coronal proton density (PD) MRI between 2017 and 2020 were included. Five independent raters measured coalition width, healthy posterior facet width, and healthy middle facet width on individual slices of coronal PD hindfoot MRIs using discrete MRI measurement guidelines. Individual slice measurements were summed to determine total size of the coalition and the remaining healthy cartilage of the posterior and middle facets. Inter-rater reliability of MRI measurements between the 5 independent examiners was evaluated using intraclass correlation coefficient (ICC). ICC was calculated for total coalition width, total healthy posterior facet width, total coalition width/total healthy posterior facet width, total coalition width/total healthy middle facet width, total coalition width/total healthy subtalar facet width (posterior facet+middle facet), and total coalition width/total subtalar facet width (coalition+posterior facet+middle facet). The ICC scores for all but one of the MRI measurements indicated good to excellent inter-rater reliability among the 5 examiners. The ICC was 0.932 (95% confidence interval: 0.881-0.966) for measurement of total coalition width/total healthy posterior facet width and 0.948 (95% confidence interval: 0.908-0.973) for measurement of total coalition width/total subtalar facet width (middle+posterior+coalition). Measurements of coalition size using novel MRI guidelines were reproducible with good to excellent inter-rater reliability. These guidelines allow for determination of TCC size using coronal PD MRI. Level II-diagnostic reproducibility study.

Validation of the Arabic translation of the caries impacts and experiences questionnaire for children.

The recently developed Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) is originally an English questionnaire targeting the assessment of caries-related quality of life from a child's point of view. This study aimed to translate and adapt the CARIES-QC into the Arabic language and to test its reliability and validity on Arabic-speaking children. A total of 234 children aged 5-16years answered the translated questionnaire. Internal consistency was measured using Cronbach's alpha; 62 children answered the questionnaire again to evaluate the test-retest reliability by calculating the intraclass correlation coefficient (ICC). Convergent validity was evaluated by correlating question scores with global question scores. Confirmatory factor analysis (CFA) was conducted to evaluate cross-cultural validity. Cronbach's alpha of the CARIES-QC/A was 0.905. The inter-item correlation coefficients of the CARIES-QC/A ranged from 0.240 to 0.850. The total ICC score was 0.960. CFA demonstrated acceptable fit to the data in the one-factor model. Convergent validity indicated moderate correlation with the global question (rs =.740). The CARIES-QC/A is a valid and reliable tool that could be used to evaluate oral health-related quality of life in Arabic-speaking children.

Critical Appraisal of Guidelines for Antithrombotic Therapy in Atrial Fibrillation Post-Percutaneous Coronary Intervention.

Objective:In our present study, our objective was to appraise guidelines on antithrombotic therapy in atrial fibrillation post-percutaneous coronary intervention and to explore the differences in treatment practices for better informed decision-making.Methods:We searched for English language guidelines published between January 2000 and December 2020 at MEDLINE, Embase and websites of guideline organizations. Guidelines with recommendations on antithrombotic regimens for patients with AF undergoing PCI were included. Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument was applied to assess guidelines. The reporting of conflicts of interest (COI) was evaluated separately by the RIGHT (Reporting Item for Practice Guidelines in Healthcare) checklist as supplementary items.Results:Sixteen guidelines were included, among which 13 (81.25%) were considered as ‘recommended’ and 1 (6.25%) as ‘unrecommended.’ The average scores of guidelines ranged from 55% to 88% (<60% as low quality, 60–70% as sufficient quality, and >70% as good quality). Among the 6 domains of AGREE II, scope and purpose (84%) and editorial independence(87%) were considered to be the fields in which CPGs performed best, evidenced by the highest mean AGREE II scores. The domains in which the reviewed CPGs received the lowest mean scores were stakeholder involvement (63%) and applicability (58%). The intraclass correlation coefficient scores were excellent in each domain. The overall quality of the selected CPGs was optimal, with the highest score in domain ‘scope and purpose’, and the lowest score in the domain ‘applicability.’ The reporting of COI was satisfactory.Conclusions:For the recommendations on antithrombotic strategies, guidelines with high AGREE II scores still exist discrepancy on the timing and selection. Current guidance documents on the treatment vary in methodological rigor and recommendations are not always consistent.

Abstract P1-08-10: Ki67 assessment based on international Ki67 working group recommendations and correlation with 21-gene assay results in a large integrated health care system: We might not be there yet

Abstract Background: While substantial evidence indicates that Ki67, a marker of proliferation, is strongly associated with breast cancer outcomes, its clinical utility has been limited given concerns about scoring inter-rater reliability and appropriate cut points. Nonetheless, Ki67 has been used in multiple clinical trials and results from POETIC indicated that low baseline Ki67 (ie, &amp;lt;10%) predicts good prognosis in postmenopausal women with hormone sensitive, early breast cancer. Further, the International Ki67 Working Group (IKWG) has developed website-based training materials to improve reproducibility of Ki67 scoring by immunohistochemistry (IHC) and recently considered the marker to be sufficiently validated to support treatment decisions in early ER+ breast cancer (≤ 5 no chemotherapy, ≥30 chemotherapy indicated). Our aims were to examine Ki67 scoring reproducibility following IKWG training and the extent to which low or high scores could accurately identify patients with low or high 21-gene assay Recurrence Scores (RS) who could selectively avoid this test. Methods: Setting and study population. The study was conducted within Kaiser Permanente Northern California (KPNC), an integrated health care system with over 4.4 million enrollees. We included a random sample of women aged 50+ years at diagnosis of node-negative, ER+PR+HER2- breast cancer with the 21-gene assay done on their surgical specimen from 2018-2020 (n=307). Ki67 staining, training and scoring. We retrieved archived core biopsy specimens, which were sent to NeoGenomics Laboratories, Inc for Ki67 staining and scoring by image analysis (IA) using the hot spot counting method. In addition, two KPNC pathologists specializing in semiquantitative IHC scoring underwent IKWG training and independently scored all slides using the global counting method, blinded to each other and to readings by AI; weighted Ki67 scores were calculated. Analysis. We examined inter-rater reliability across pathologists using intraclass correlation (ICC) and Kappa statistics. We also examined the percent of patients with low Ki67 scores (≤ 5, &amp;lt;10) by each pathologist and by AI who also had low RS (&amp;lt;26) and the percent who had high Ki67 scores (≥30) who also had high RS (≥26). Results: Approximately 83% of patients were ages 50-69 years (median 63), 61% were non-Hispanic white and 93% were stage 1A. The ICC for Ki67 scores (log-transformed) by the two pathologists was 0.82; using a dichotomous cut point of &amp;lt;10 vs ≥10%, the Kappa for the inter-rater reliability was 0.65. Among patients with Ki67 scores of &amp;lt;10% by IA (n=81), pathologist 1 (n=120) or pathologist 2 (n=111), the percent with a RS of &amp;lt;26 was 95.1% for IA, 95.8% for pathologist 1, and 94.6% for pathologist 2. Among patients with Ki67 scores ≤5, the percentages were 90.9%, 92.6% and 91.8% for IA, pathologist 1 and pathologist 2, respectively. Among patients with Ki67 scores ≥30 by AI (n=69), pathologist 1 (n=41) or pathologist 2 (n=35), the percent who had a RS ≥26 was 27.5% for IA, 41.5% for pathologist 1 and 51.4% for pathologist 2. Results are improved if we exclude all 50 patients with weak PR by IHC (1-10%); for example, among patients with Ki67 scores of &amp;lt;10%, the percent with a RS of &amp;lt;26 was 97.1% for IA, 98.1% for pathologist 1, and 97.9% for pathologist 2. Conclusion: Among women aged 50+ years with node-negative, ER+PR+HER2- breast cancer in our setting, approximately 5-10% of patients with Ki67 scores of ≤ 5% or &amp;lt;10% on core biopsies would have high RS (≥26) on surgical specimens and over 48% of cases with Ki67 scores ≥30 would have low RS (&amp;lt;26), which may be insufficiently accurate for avoiding the 21-gene or other multi-gene assays. Future studies are needed to examine whether restricting Ki67 testing to ER+HER2- patients with PR &amp;gt;10% would improve its clinical validity. Citation Format: Veronica C. Shim, Robin J Baker, Wen Jing, Sally S Agersborg, Thomas K Lee, Wamda Goreal, Ninah Achacoso, Catherine Lee, Marvella Villasenor, Amy Lin, Malathy Kapali, Laurel A Habel. Ki67 assessment based on international Ki67 working group recommendations and correlation with 21-gene assay results in a large integrated health care system: We might not be there yet [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-08-10.

Validity and reliability of the spiritual care competency scale for oncology nurses in Taiwan

BackgroundNurses must have spiritual competence to provide holistic patient care. Therefore, the designed instrument to assess nurses’ competence could be a practical guide for health care professionals. This study aimed to evaluate the validity and reliability of the spiritual care competency scale (SCCS) for oncology nurses in Taiwan.MethodsThis study used a convenience sample from a regional teaching hospital in Taiwan from November 2017 to February 2019, who were asked to complete the SCCS. We employed scale-content validity index (S-CVI). Exploratory Factor Analysis (EFA) was also used to evaluate the structural factor of SCCS. Confirmatory Factor Analysis (CFA) verified the construct validity of SCCS scale for oncology nurses in Taiwan. Test–retest reliability were also measured in this study at 2-week interval.ResultsThe average S-CVI of SCCS was 0.96. The EFA produced four factors of 27 items, such as professionalization, improving the quality of spiritual care, personal support, patient counseling and referral, attitude towards patient spirituality and communication, assessment, implementation providing and evaluation of spiritual care. Fitting the 27 items yielded an acceptable model fit; X2/df = 2.41, RMSEA = 0.08, GFI = 0.80, AGFI = 0.80, CFI = 0.92, IFI = 0.92, NFI = 0.90, RFI = 0.90, TLI = 0.91, SRMR = 0.06. Cronbach’s alpha values were between 0.93 and 0.95, and the total Cronbach’s alpha was 0.96. The intraclass correlation coefficient (ICC) scores were between 0.43 and 0.88.ConclusionsThe result of this study demonstrated satisfactory validity and reliability for the SCCS in the nursing field in Taiwan. Implications for practice in this study serves as a reference for effectively evaluating nursing competency in spiritual care.

The effect of skeletal muscle area and attenuation in patients with sternum fracture due to blunt chest trauma.

This study aims to retrospectively investigate the imaging features of patients with sternum fracture (SF) and concomitant organ injuries. We also aimed to evaluate the potential prognostic effect of skeletal muscle area (TMA) and muscle attenuation (MuA) values. Computed tomography (CT) images of patients with SF were re-evaluated by two observers (Observer-1 and 2). Observer-3 has measured TMA and MuA values. Observer-1 has repeated the measurements blindly to the first measurement results to evaluate the inter-observer agreement. The length of hospital stay, death, hemiplegia, or quadriplegia were investigated from the archives. Mann-Whitney U-test or Student's t-test was used to investigate the relationship between linear variables. The intraclass correlation coefficient (ICC) score was used to evaluate the interobserver agreement. Logistic regression analysis was used to estimate the relative effect of variables by calculating unadjusted odds ratios (ORs) for categorical outcomes. Sixty-five patients had SF and 53 patients had SF and concomitant organ injuries. The most common injuries accompanying SF were rib fracture (73.58%) and lung contusion (60.38%). Manubrium fracture was the most common fracture location (52.3%), and 18 patients (27.7%) had displaced SF. Eight patients (15.1%) were discharged with plegia and five (9.4%) died. Hemothorax, displaced SF and decreased MuA were predictors of prolonged hospital stay, and the presence of cardiac contusion, displaced SF, hemothorax, and vertebra body fracture were independent factors for death. The presence of a displaced SF and decreased MuA value are important prognostic factors in patients with SF.

Development of Assessment Tool to Measure Children's Knowledge on Dengue Prevention Activities in Malaysia.

Dengue is one of the public health concerns in developing and developed countries. Since the main control measure for dengue is health prevention and control activities, especially among children, it is essential to assess children's knowledge on dengue prevention activities in preventing the disease. This study aimed to develop an assessment tool (CAB-IHBR-Dengue-C-01) attempting to measure children's knowledge of dengue prevention activities in Malaysia. Twelve (12) pictorials with descriptions were developed to capture children's understanding of the correct method of dengue prevention activities. Cronbach' alpha test was used to assess the internal consistency of the items, and the test and retest reliability method was used to measure the consistency of the questionnaire. For test-retest reliability analysis, tests were conducted twice, with an interval of two (2) weeks from the first test. In total, 58 respondents comprising of Malay, Chinese, and Indian aged between 7 and 12 years old were included in this study. The results showed the intraclass correlation coefficient (ICC) score was 0.640; with moderate reliability; meanwhile, Cronbach's alpha score was 0.606. In conclusion, CAB-IHBR-Dengue-C-01 (Cognitive Affective Behaviour-Institute for Health Behavioural Research-Dengue-Children-Version 01) is reliable to be used.

AM-UNet: automated mini 3D end-to-end U-net based network for brain claustrum segmentation.

Recent advances in deep learning (DL) have provided promising solutions to medical image segmentation. Among existing segmentation approaches, the U-Net-based methods have been used widely. However, very few U-Net-based studies have been conducted on automatic segmentation of the human brain claustrum (CL). The CL segmentation is challenging due to its thin, sheet-like structure, heterogeneity of its image modalities and formats, imperfect labels, and data imbalance. We propose an automatic optimized U-Net-based 3D segmentation model, called AM-UNet, designed as an end-to-end process of the pre and post-process techniques and a U-Net model for CL segmentation. It is a lightweight and scalable solution which has achieved the state-of-the-art accuracy for automatic CL segmentation on 3D magnetic resonance images (MRI). On the T1/T2 combined MRI CL dataset, AM-UNet has obtained excellent results, including Dice, Intersection over Union (IoU), and Intraclass Correlation Coefficient (ICC) scores of 82%, 70%, and 90%, respectively. We have conducted the comparative evaluation of AM-UNet with other pre-existing models for segmentation on the MRI CL dataset. As a result, medical experts confirmed the superiority of the proposed AM-UNet model for automatic CL segmentation. The source code and model of the AM-UNet project is publicly available on GitHub: https://github.com/AhmedAlbishri/AM-UNET.

Validation of an on-screen application-based measurement of shoulder range of motion over telehealth medium.

Shoulder range-of-motion (ROM) assessment is vital for the follow-up evaluation of operated patients and for the outcome-based research studies. The aim of this study was to investigate the accuracy and reliability of a remote on-screen application (app)-based method of shoulder ROM measurement through a telehealth medium. A consultant shoulder surgeon, a board-certified orthopedic resident, and a graduate medical doctor served as the examiners. The cohort consisted of 24 healthy volunteers and 16 symptomatic patients with expected shoulder ROM deficits. Shoulder ROM was first examined physically using a goniometer in the clinic and then over Zoom remote conferencing using the protractor extension app of the Chrome browser. Instrument validity was examined by comparing the goniometer method with the protractor app-based method of the expert shoulder consultant using Bland-Altman analysis. It showed only minor mean differences between the healthy volunteers and the patients in elevation (2.0° and 5.0°, respectively), abduction (2.0° and 3.0°, respectively), external rotation with the elbow adducted (1.9° and 0.2°, respectively), external rotation with the elbow abducted at 90° (0.4° and 4°, respectively), and internal rotation with elbow abducted at 90° (2.3° and 1.2°, respectively), with limits of agreement that were below the well-established minimal clinically important difference values. The intraclass correlation coefficient (ICC) values varied between 0.83 and 0.96 for the volunteers and between 0.90 and 0.98 for the patients, indicating excellent correlation between the 2 methods. The interobserver reliability between 2 examiners for the protractor app-based method as evaluated by ICC scores was excellent; it ranged between 0.86 and 0.98 for the volunteers and between 0.88 and 0.99 for the patients. Comparison of the protractor app-based method with the gold-standard goniometer method for the resident and the graduate doctor showed excellent ICC values. A protractor app-based method of measuring shoulder ROM over a telehealth medium is accurate and reliable compared with a clinical goniometer method. This validated method can be used during remote telehealth consultation with significant benefits of saving patients travel and time during the COVID-19 (coronavirus disease 2019) pandemic and even later.

Intrarater and Inter-rater Reliability of Pinch Dynamometer for Toe Grip Strength: A Cross-sectional Study

Introduction: Reduced Toe Grip Strength (TGS) is associated with an increased risk of knee pain. In India, toe grip is rarely examined and examination of TGS lacks quantifiable values. The pinch gauge dynamometer is an instrument/tool which is apposite in the assessment of grip strength. This study is a first of its kind to establish the reliability of pinch gauge dynamometer in assessing TGS. Aim: To evaluate intrarater and inter-rater reliability of pinch gauge dynamometer in measuring TGS. Materials and Methods: This cross-sectional study was conducted at the Department of Physiotherapy, deemed to be the university of Mangalore, Karnataka, India during the 1st week of August 2022. Out of 30 individuals, 15 were males and 15 were females. TGS was assessed using a Pinch gauge dynamometer. For data analysis, the mean of the three trials was used and the reliability test was calculated using the Intraclass Correlation Coefficient (ICC). The level of significance was set at 5%. Results: Intrarater reliability showed ICC scores of 0.991 and 0.985 for both right and left feet, and inter-rater reliability showed scores of 0.985 and 0.977, respectively. In the female group inter-rater agreement on right side pinch strength was 0.923 and left side was 0.924. Among males inter-rater agreement, right side ICC score was 0.983 and left side was 0.967 between the raters. Conclusion: The pinch gauge dynamometer is reliable for measuring TGS with excellent intra and inter-rater reliability values.

A simplified CT-volumetry method for the canine liver.

Computed tomographic (CT) liver volumetry using the slice addition technique is an accurate, but a time-consuming method. Commonly used DICOM-viewing software only allows contouring of one area per image, which can be troublesome in the transverse plane as different lobes are separated. In this prospective, experimental, methods comparison study, we aimed to determine if hepatic contouring using sagittal reformatting and a reduced number of images would yield accurate results. Computed tomographic studies were performed in five canine cadavers and reviewed using sagittal reformatting. For each dog, the number of images that included the liver was used to create four stacks with progressively fewer images in which the liver would be contoured, each with the following median number of images: A: 60, B: 31, C: 16, and D: 9. Liver volume was calculated by three observers using the different stacks of images. After CT examination, the cadavers were dissected, the liver was removed, and its volume was determined by water displacement. Single score intraclass correlation coefficient was calculated to assess interobserver agreement. Kruskal-Wallis test was used to compare water displacement and CT-based volumes. There was excellent agreement between observers (intraclass correlation coefficient=0.957; 95% confidence interval,0.908-0.982, P<0.0001). No significant difference was found between the volumes obtained by CT-volumetry using each of the stacks and the volumes obtained by water displacement. Using sagittally reformatted images and hepatic contouring in as few as nine images can be an accurate and simple method for CT-volumetry of the canine liver.

Validity and Reliability Measurement of Bengali Translated Questionnaire for Urinary Incontinence Diagnosis

Objective: The aim of this study was to translate and verify the validity and reliability of the Bengali translated questionnaire for Urinary Incontinence Diagnosis (QUID), to ensure the diagnosis of urinary incontinence in Bangladesh.Material and Methods: Adaptation and psychometric properties testing of the Bengali-QUID were conducted with 67 respondents. Twenty respondents were included for pre-testing and adaptation; whereas, 47 respondents were considered for test-retest reliability. The content validity of the questionnaire was measured by expert opinion. Cornbach’s alpha statistical test was used to measure the internal consistency of the questionnaire, while the test-retest reliability was measured using the Intra-Class Correlation (2,1) model.Results: Content validity for all items of the questionnaire was &gt;0.75. In addition, the Cronbach's Alpha values for interitem correlation for Stress Urinary Incontinence and Urge Urinary Incontinence were (α&gt;0.8) and (α&gt;0.7), respectively. Furthermore, the reliability of the Bengali-QUID questionnaire had an Intra-class correlation score of 0.76.Conclusion: This study demonstrated that the Bengali version of QUID questionnaire was highly valid, and reliable for diagnosis of urinary incontinence among Bangladeshi women.

Reliability and validity of the Turkish version of Post-COVID-19 Functional Status Scale

Background/aimThe post-COVID-19 Functional Status (PCFS) has recently been developed for functional outcomes of COVID-19 upon discharge and in long term. The purpose of this study was to investigate the reliability and validity properties of the Turkish version of the PCFS in Turkish post-COVID-19 patients with hospitalized and nonhospitalized during infection.Materials and methods One hundred participants with post-COVID-19 were included in this cross-sectional study. Test-retest reliability of the Turkish version of PCFS assessed by intraclass correlation coefficient (ICC) and Cronbach’s alpha was calculated for internal consistency. For construct validity, correlation coefficients between the Turkish version of PCFS developed by translation-back translation method and modified Medical Research Council (mMRC) dyspnea scale (MMRC), London Chest Activities of Daily Living (LCADL) scale, Barthel Index (BI) were analyzed.Results For test-retest reliability analysis, ICC ranged between 0.734 and 0.880. The total ICC score was 0.821, indicating excellent reliability. The Cronbach’s alpha value of the PCFS test and retest scores were recorded as 0.821 indicating that the scale is quite reliable. The PCFS score was moderately correlated with the mMRC score (r = 0.534, p < 0.001) and weakly correlated with the LCADL self care (r = 0.311, p = 0.002), domestic (r = 0.277, p = 0.005), physical activity (r = 0.342, p < 0.001), leisure subscores (r = 0.434, p < 0.001) and total score (r = 0.399, p < 0.001).Conclusion The Turkish version of the PCFS scale is reliable scale that reflects activity limitation and functional status after COVID-19. The Turkish version of the PCFS will be a guide for rehabilitation professionals to understand functional limitation after COVID-19 and to direct interventions accordingly to functional status of the patients at discharge and in long term.

The Reproducibility of Deep Learning-Based Segmentation of the Prostate Gland and Zones on T2-Weighted MR Images.

Volume of interest segmentation is an essential step in computer-aided detection and diagnosis (CAD) systems. Deep learning (DL)-based methods provide good performance for prostate segmentation, but little is known about the reproducibility of these methods. In this work, an in-house collected dataset from 244 patients was used to investigate the intra-patient reproducibility of 14 shape features for DL-based segmentation methods of the whole prostate gland (WP), peripheral zone (PZ), and the remaining prostate zones (non-PZ) on T2-weighted (T2W) magnetic resonance (MR) images compared to manual segmentations. The DL-based segmentation was performed using three different convolutional neural networks (CNNs): V-Net, nnU-Net-2D, and nnU-Net-3D. The two-way random, single score intra-class correlation coefficient (ICC) was used to measure the inter-scan reproducibility of each feature for each CNN and the manual segmentation. We found that the reproducibility of the investigated methods is comparable to manual for all CNNs (14/14 features), except for V-Net in PZ (7/14 features). The ICC score for segmentation volume was found to be 0.888, 0.607, 0.819, and 0.903 in PZ; 0.988, 0.967, 0.986, and 0.983 in non-PZ; 0.982, 0.975, 0.973, and 0.984 in WP for manual, V-Net, nnU-Net-2D, and nnU-Net-3D, respectively. The results of this work show the feasibility of embedding DL-based segmentation in CAD systems, based on multiple T2W MR scans of the prostate, which is an important step towards the clinical implementation.

Inter- and intrarater reliability of measuring lengthening of magnetically controlled growing rods on digital radiographs.

The aim of this study was to determine inter- and intraobserver reliability of delta rod extension, and total rod length measured on digital x-rays in patients with early onset scoliosis (EOS) treated with magnetically controlled growing rods (MCGR). For the last decade, patients with EOS have been treated with MCGR. Replacement of MCGR relies heavily on the measurement done at every lengthening session. Only a few studies have looked at inter- and intraobserver reliability of rod lengthening, and none have used the delta extension before. 202 radiographs presented in random order were rated and measured twice with at least a 14-day interval and differing order of the radiographs. The measuring was done at both rods. All x-rays came from 15 patients diagnosed with EOS and treated with MCGR from 2009 until 2019. The total extension length and the delta extension (the difference in total extension length between two lengthening in succession) were measured, and the intraclass correlation coefficient (ICC) calculated for both measurements RESULTS: Intrarater ICC scores varied from moderate to good, but non-significantly. Interrater reliability increased significantly from moderate (ICC 0.72 [0.68; 0.76] and 0.73 [0.69; 0.77] to excellent (ICC 0.91 [0.88; 0.93] and 0.97 [0.96: 0.98]), when examining delta extension every sixth instead of every second month. Measuring rod lengthening on x-rays can be done every 6months, with an ample reliability. The ICC's for the delta extension with 2-3months interval were only moderately precise, compared to the near perfect ICC's for the total extension length.

P–792 The introduction of an embryo morphokinetics annotation quality assurance scheme across ten fertility clinics including 59 participants

Abstract Study question Can a group-wide quality assurance scheme be developed to effectively determine inter-operator agreement for morphokinetic parameters of interest. Summary answer Very strong agreement was found between all operators except for one, therefore this scheme effectively identified areas of improvement in inter-operator annotations. What is known already Where fertility clinics use embryo morphokinetics to determine viability potential, quality assurance of annotations is essential. Embryo selection algorithms rely on the manual determination of certain morphokinetic parameters. Variations in these parameters can lead to differences in the algorithm score attributed to an embryo thus potentially affecting its fate. It is vital that all embryologists involved in embryo annotation and selection are consistent with their annotation approach through regular quality assurance mechanisms. Study design, size, duration Each participant was required to annotate the same three embryos for morphokinetic parameters of interest, including tPB2, tPNf, t2 to t5, t8, tM, tSB, tB. Participants were also required to grade embryos at 68 hours post insemination (hpi), 112hpi and to assess additional parameters used for embryo selection or future investigations, such as the extent of morula compaction. The aim of this scheme is to release new distribution each quarter to ensure regular participation. Participants/materials, setting, methods All embryologists responsible for embryo annotation in a single, UK fertility group were enrolled onto the scheme. A total of 59 participants from 10 fertility clinics in the UK were included. Inter-operator agreement was assessed using two-way, mixed intraclass correlation coefficient (ICC) for consistency. Five categories of agreement were determined based on ICC score; very weak (0–0.2), weak (0.21–0.4), moderate (0.41–0.6), strong (0.61–0.8) and very strong (0.81–1.0). Main results and the role of chance Very strong agreement (0.81–1.0) was observed between all operators for all parameters assessed except for one operator who showed a weak agreement (0.21–0.4) with all other operators. Descriptive statistics revealed standard deviations (SD) ranging from 0.34 (t3) to 3.43 (t5). For each parameter the SD across the three assessed embryos ranged from 0.34–3.43; tPB2 (0.11–0.98), tPNf (2.06–4.40), t2 (0.22–0.80), t3 (0.16–0.70), t4 (0.39–0.65). t5 (2.40–5.44), t8 (0.33–2.72), tM (1.00–2.72), tSB (1.08–2.67), tB (1.12–1.81). These results indicate a high concordance with less subjective annotations such as the cell stage divisions and more variability with the subjective annotations such as the blastulation parameters. The concordance with less well practiced or understood annotations, such as extent of morula compaction, planar or tetrahedral orientation at the four cell stage as well as angle of extrusion of second polar body in relation to the first polar body, was poorer as indicated using descriptive statistics. This highlighted the need for experience in performing these annotations before drawing conclusions regarding their predictive nature in relation to an embryo’s viability. Limitations, reasons for caution The variability between more subjective parameters would be expected to be higher than others. The participation in these schemes can create false environments which do not reflect how an embryologist would usually score; they may spend longer on some decisions given the nature of the scheme. Wider implications of the findings: Quality assurance of morphokinetic annotations across clinics utilising standardised selection models is crucial. Robust annotation policies and education programmes are essential in achieving consistent results between operators. Quality assurance schemes can identify individuals who lack consistency overall and can identify reliably annotated parameters to inform inclusion in embryo selection algorithms. Trial registration number Not applicable

Abstract CT161: A homologous recombination repair (HRR) functional assay to stratify patients with metastatic prostate cancer for PARP inhibitor treatment in the TOPARP-B clinical trial

Abstract Background: PARP inhibitors (PARPi) are approved for the treatment of metastatic prostate cancer (mPC) associated to various DNA damage repair (DDR) gene mutations; but clinical benefit differs among patients. Biomarkers of homologous recombination repair (HRR) deficiency may help refine patient stratification for a more precise therapy selection. We report an exploratory analysis from the TOPARP-B phase II clinical trial of olaparib in mPC (NCT01682772), investigating the predictive value of an HRR function assay detecting RAD51 foci by immunofluorescence in tumor biopsies. Design: We analyzed formalin-fixed paraffin-embedded (FFPE) primary or metastatic biopsies from mPC patients treated with olaparib in the clinical trial. We evaluated baseline HRR function based on detection of RAD51 and γH2AX foci in geminin-positive tumor cells by immunofluorescence (IF). All samples were scored by two trained readers blinded to genomic and clinical data. Samples were considered HRR deficient (HRD) when RAD51 scores were low, pre-defined as &amp;lt;10% tumor cells presenting ≥5 RAD51 foci/cell. The association of the RAD51 score, response to olaparib and survival (radiographic progression-free survival, rPFS, and overall survival, OS) was analyzed by Chi-Square and log-rank tests. Results: RAD51 and γH2AX were successfully scored in 52 cases, in the same biopsies previously used for NGS in the clinical trial. All tumors showed abundant DNA damage (γH2AX scores &amp;gt;40%). The intra-class correlation score (ICC) between the two blinded readers was 0.88. Overall, 22 of 52 (42%) cases were considered as HRD based on low RAD51 scores. Response rate (based on the composite RECIST/PSA/CTC trial criteria) was 15/22 (68%) vs 7/30 (23%) for patients with low vs high RAD51 scores (p=0.001). Patients with low RAD51 scores also had longer rPFS (median 9.3 vs 2.9 months p=0.002) and overall survival (median 17.4 vs 9.5 months, p=0.05) from initiation of olaparib. All 16/16 cases with BRCA1/2 alterations were identified as RAD51 low. For patients with PALB2 mutations, 2/2 patients with biallelic loss showed RAD51 low scores and responded to olaparib, whereas 2/2 patients with monoallelic PALB2 mutations showed RAD51 high scores and did not respond to olaparib. Mutations in ATM and CDK12 did not associate with low RAD51. Indeed, 10/11 ATM-mutated and 8/10 CDK12-mutated tumors presented high RAD51 scores; RECIST/PSA responses were observed in two patients with ATM mutations and high RAD51 scores. Conclusion: A RAD51-based IF assay performed on FFPE biopsies can detect prostate cancers with deficient HRR function, including BRCA1/2 and biallelic PALB2 mutated cases, and may be useful for patient stratification for PARP inhibitor treatment in prostate cancer. Further validation of the assay in larger cohorts is warranted. Citation Format: Sara Arce-Gallego, Alba Llop-Guevara, Suzanne Carreira, Nuria Porta, Roberta Fasani, Diletta Bianchini, George Seed, Pasquale Rescigno, Alec Paschalis, Claudia Bertan, Chloe Baker, Jane Goodall, Susana Miranda, Ruth Riisnaes, Ines Figueiredo, Ana Ferreira, Rita Pereira, Bora Gurel, Daniel Nava Rodrigues, Wei Yuan, Jan Rekowski, Emma Hall, Violeta Serra, Johann S. de Bono, Joaquin Mateo. A homologous recombination repair (HRR) functional assay to stratify patients with metastatic prostate cancer for PARP inhibitor treatment in the TOPARP-B clinical trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr CT161.

Parent-child discrepancies in health-related quality of life of children and adolescents with myalgic encephalomyelitis/chronic fatigue syndrome.

Few studies have examined parent-child discrepancies on self-report measures of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) symptomatology and health-related quality of life (HRQOL). The aim of this study was to investigate parent-child reporting discrepancies between a pediatric sample of diagnosed patients with ME/CFS and controls to better understand the role of children and adolescent reporting. Data for this study were drawn from a community-based epidemiological study of pediatric ME/CFS in the Chicagoland area. A total of 147 parent-child dyads (75 pairs with ME/CFSand 72 control pairs) completed measures assessing HRQOL and ME/CFS symptomatology. At the individual level, agreement was assessed using intra-class correlation coefficient (ICC) scores. Agreement was measured at the group level by a comparison of means using paired-sample t-tests. Intra-class correlations revealed varied agreement in both parent-child pairs of children who met at least one case definition of ME/CFS and in parent-child pairs in the control group. The current study provides support for the existence of discrepancies between parent-child reports of ME/CFS symptomatology and HRQOL measures. Limitations and future directions are discussed.

Deep learning for semi-automated unidirectional measurement of lung tumor size in CT

BackgroundPerforming Response Evaluation Criteria in Solid Tumor (RECISTS) measurement is a non-trivial task requiring much expertise and time. A deep learning-based algorithm has the potential to assist with rapid and consistent lesion measurement.PurposeThe aim of this study is to develop and evaluate deep learning (DL) algorithm for semi-automated unidirectional CT measurement of lung lesions.MethodsThis retrospective study included 1617 lung CT images from 8 publicly open datasets. A convolutional neural network was trained using 1373 training and validation images annotated by two radiologists. Performance of the DL algorithm was evaluated 244 test images annotated by one radiologist. DL algorithm’s measurement consistency with human radiologist was evaluated using Intraclass Correlation Coefficient (ICC) and Bland-Altman plotting. Bonferroni’s method was used to analyze difference in their diagnostic behavior, attributed by tumor characteristics. Statistical significance was set at p < 0.05.ResultsThe DL algorithm yielded ICC score of 0.959 with human radiologist. Bland-Altman plotting suggested 240 (98.4 %) measurements realized within the upper and lower limits of agreement (LOA). Some measurements outside the LOA revealed difference in clinical reasoning between DL algorithm and human radiologist. Overall, the algorithm marginally overestimated the size of lesion by 2.97 % compared to human radiologists. Further investigation indicated tumor characteristics may be associated with the DL algorithm’s diagnostic behavior of over or underestimating the lesion size compared to human radiologist.ConclusionsThe DL algorithm for unidirectional measurement of lung tumor size demonstrated excellent agreement with human radiologist.

Turkish validity and reliability of the COVERS pain scale.

The objective of this study is to determine the Turkish validity and reliability of COVERS. This study was conducted on 41 newborns as methodological design. The scales, such as newborn information form, COVERS, preterm infant pain profile (PIPP), and neonatal infant pain scale (NIPS), were used in the study. Validity (e.g., language, content concurrent, and construct) and internal consistency and inter-rater reliability of the scale were conducted. It was found that COVERS showed a high correlation with PIPP and NIPS, and the item-total correlation of COVERS was above 0.30 during and after heel lance procedure. The Cronbach's α values were 0.77 and 0.83 during and after heel lance procedure, respectively. The kappa values of the items of COVERS were between 0.38 and 0.78 during heel lance procedure. It was concluded in this study that there was a moderate correlation in intraclass correlation coefficients for scores of COVERS during both diaper change and heel lance procedures. It has been concluded that the scale is valid and reliable in 27-week-old and older newborns.