Kappa Statistic For Agreement Research Articles

Correlation Between Clinical Assessment and Postmortem Lung Biopsy in Patients With Pulmonary Infiltrates and Respiratory Failure.

Pulmonary complications commonly cause mortality in critically ill patients with acute and chronic liver diseases in the intensive care unit. Pneumonia is the most common clinical diagnosis supported by radiological and microbiological results, which are subjective and often with poor yield. The study aimed to correlate clinical diagnosis and postmortem lung histology in patients with liver disease with respiratory failure. Records of acute and chronic liver disease patients with respiratory failure-associated mortality and postmortem lung biopsy from September 2009 to March 2020 were analyzed. Clinical diagnosis supported by radiological and/or microbiological data was compared with histology. One hundred eight patients (age 46.83±12.96 years), males 80 (74.1%), 63 (58.3%) cirrhosis of the liver, 30 (27.8%) acute-on-chronic-liver-failure, and 9 (8.3%) acute liver failure, were analyzed. Of the 76 patients (70.37 % of the total) with pneumonia, 33 (43.4 %) had histological evidence of pneumonia. Other histological diagnoses in these patients were normal or nonspecific changes in 27 (35.5 %) and alveolar hemorrhage in 13 (17.1 %). In the remaining 32 patients, histological diagnosis of pneumonia was evident in nine patients (28.1%). Using postmortem histology as the gold standard, the sensitivity, specificity, positive predictive value, and negative predictive valuefor clinical diagnosis of pneumonia were found to be 78.57%, 34.85%, 43.42%, and 71.88% respectively. The kappa statistics for agreement between the two was 0.12 (95% C.I. -0.04 to 0.27) suggesting poor agreement. Age and histological pneumonia predicted significant missed diagnosis. There is poor agreement between clinical diagnosis and postmortem histology. Postmortem lung biopsy helps with the unexplained cause of death.

"Am I really fat/thin?!" Self-perceived body image and correlation with nutritional status among medical students in Central Gujarat.

Adolescence is a crucial part of life characterised by rapid body changes that can be influenced by perceptions and misinformation regarding their body image. Body image is usually associated with self-esteem and self-worth. Therefore, it is important to address this issue at this transitional time. This study aims to understand the perception of body image and its correlation with nutritional status among first-year medical students. A cross-sectional study was conducted among first-year medical students enrolled in the MBBS curriculum. Data related to perception of body image were collected through a self-administered, pre-tested questionnaire. Height and weight were taken by the principal investigator at the time of data collection and body mass index (BMI) was calculated according to Asian criteria for BMI. Kappa statistics were used for the agreement between self-perceived body image and BMI. A total of 234 out of the 250 students enrolled in the first year gave consent for the study. The median (interquartile range [IQR]) age of the students was 18 (17-19) years and 72% were male students. One-fourth of the students were dissatisfied with their weight (26.9%) followed by height (25%). The Kappa statistics for agreement between BMI and self-perception about body weight was 0.373 (95% confidence interval [CI], standard error (SE) of Kappa = 0.048), showing poor agreement. One-fourth of the students were dissatisfied with their physical appearance. The agreement between perceived body weight and nutritional status was poor (64.53%).

Contrast enhanced ultrasound of liver lesions in patients treated for childhood malignancies

BackgroundPatients treated for cancer have a higher incidence of focal liver lesions than the general population and there is often concern for a malignant etiology. This can result in patient, caregiver and physician anxiety and is managed by a “wait and watch” approach, or immediate additional imaging, or biopsy, depending on the degree of clinical concern. Because it is a low-cost, easily accessible, radiation and sedation free modality, we investigated the value of contrast enhanced ultrasound (CEUS) to accurately distinguish benign from malignant liver lesions in patients treated for childhood malignancies.MethodsWe performed an IRB approved retrospective study of 68 subjects who were newly diagnosed, on treatment or off treatment for a pediatric malignancy and had liver lesions discovered on CT, MRI or non-contrast ultrasound and subsequently underwent CEUS between September 2013 and September 2021. Two experienced pediatric radiologists and a radiology trainee, blinded to the etiology of the liver lesions, independently reviewed the CEUS examinations and categorized lesions as benign, indeterminate, or malignant. The reference standard was biopsy for 19 lesions and clinical follow-up for 49. The sensitivity, specificity, positive and negative predictive value, and diagnostic accuracy of CEUS were calculated using only the benign and malignant CEUS classifications. Inter-reviewer agreement was assessed by Cohen’s kappa statistic.ResultsThere were 26 males and 42 females, mean age, 14.9 years (range, 1–52 years). Fifty subjects were off therapy, twelve receiving treatment, and six with newly diagnosed cancer. By the reference standard, 59 (87%) lesions were benign and 9 (13%) were malignant. Sensitivities of CEUS for the three reviewers ranged from 83 to 100% (95% CI, 35.9-100%), specificities from 93.1 to 96.0% (95% CI, 83.5-99.6%), PPV 60.0-71.4% (95% CI, 29.0-96.3%), NPV 98.0-100% (95% CI, 89.2-100%) and accuracy from 93.8 to 94.6% (95% CI, 85.1-99.7%). The kappa statistic for agreement between the two experienced radiologists was moderate at 0.58.ConclusionsCEUS is highly accurate in distinguishing benign from malignant etiologies of liver lesions in patients treated for pediatric malignancies.

Machine learning methods in automated detection of CT enterography findings in Crohn's disease: A feasibility study

PurposeQualitative findings in Crohn's disease (CD) can be challenging to reliably report and quantify. We evaluated machine learning methodologies to both standardize the detection of common qualitative findings of ileal CD and determine finding spatial localization on CT enterography (CTE). Materials and methodsSubjects with ileal CD and a CTE from a single center retrospective study between 2016 and 2021 were included. 165 CTEs were reviewed by two fellowship-trained abdominal radiologists for the presence and spatial distribution of five qualitative CD findings: mural enhancement, mural stratification, stenosis, wall thickening, and mesenteric fat stranding. A Random Forest (RF) ensemble model using automatically extracted specialist-directed bowel features and an unbiased convolutional neural network (CNN) were developed to predict the presence of qualitative findings. Model performance was assessed using area under the curve (AUC), sensitivity, specificity, accuracy, and kappa agreement statistics. ResultsIn 165 subjects with 29,895 individual qualitative finding assessments, agreement between radiologists for localization was good to very good (κ = 0.66 to 0.73), except for mesenteric fat stranding (κ = 0.47). RF prediction models had excellent performance, with an overall AUC, sensitivity, specificity of 0.91, 0.81 and 0.85, respectively. RF model and radiologist agreement for localization of CD findings approximated agreement between radiologists (κ = 0.67 to 0.76). Unbiased CNN models without benefit of disease knowledge had very similar performance to RF models which used specialist-defined imaging features. ConclusionMachine learning techniques for CTE image analysis can identify the presence, location, and distribution of qualitative CD findings with similar performance to experienced radiologists.

A time-adjusted control chart for monitoring surgical outcome variations.

Statistical Process Control (SPC) tools providing feedback to surgical teams can improve patient outcomes over time. However, the quality of routinely available hospital data used to build these tools does not permit full capture of the influence of patient case-mix. We aimed to demonstrate the value of considering time-related variables in addition to patient case-mix for detection of special cause variations when monitoring surgical outcomes with control charts. A retrospective analysis from the French nationwide hospital database of 151,588 patients aged 18 and older admitted for colorectal surgery between January 1st, 2014, and December 31st, 2018. GEE multilevel logistic regression models were fitted from the training dataset to predict surgical outcomes (in-patient mortality, intensive care stay and reoperation within 30-day of procedure) and applied on the testing dataset to build control charts. Surgical outcomes were adjusted on patient case-mix only for the classical chart, and additionally on secular (yearly) and seasonal (quarterly) trends for the enhanced control chart. The detection of special cause variations was compared between those charts using the Cohen's Kappa agreement statistic, as well as sensitivity and positive predictive value with the enhanced chart as the reference. Within the 5-years monitoring period, 18.9% (28/148) of hospitals detected at least one special cause variation using the classical chart and 19.6% (29/148) using the enhanced chart. 59 special cause variations were detected overall, among which 19 (32.2%) discordances were observed between classical and enhanced charts. The observed Kappa agreement between those charts was 0.89 (95% Confidence Interval [95% CI], 0.78 to 1.00) for detecting mortality variations, 0.83 (95% CI, 0.70 to 0.96) for intensive care stay and 0.67 (95% CI, 0.46 to 0.87) for reoperation. Depending on surgical outcomes, the sensitivity of classical versus enhanced charts in detecting special causes variations ranged from 0.75 to 0.89 and the positive predictive value from 0.60 to 0.89. Seasonal and secular trends can be controlled as potential confounders to improve signal detection in surgical outcomes monitoring over time.

World Health Organization Reporting System for Soft Tissue Cytopathology: Risk of malignancy and reproducibility of categories among observers.

In 2024, the World Health Organization (WHO) is scheduled to publish the WHO Reporting System for Soft Tissue Cytopathology (WHORSSTC). This system establishes categories with well-defined definitions, criteria, and estimated risks of malignancy (ROMs) for soft tissue tumors. The estimates of ROM are based on a relatively small number of published studies. Interobserver reproducibility is not addressed in the reporting system even though reproducibility of a reporting system is highly important. A manual search of one authors personal consultation files and teaching set (L.J.L.) was conducted for all cytologic specimens of soft tissue tumors accessioned between January 1, 1985 and December 31, 2022. Only cases with documented surgical pathology follow-up were included in the study. Slides from each case were evaluated independently by three cytopathologists with each case assigned to one of the WHORSSTC categories. A ROM for each of the WHORSSTC categories was calculated. Interobserver agreement was evaluated by the kappa and weighted kappa statistics. Risk for malignancy by category were: Category 1: 0%, Category 2: 28%, Category 3: 57%, Category 4: 47%, Category 5: 63%, and Category 6: 88%. Kappa statistics for agreement between raters varied from 0.2183 to 0.3465 and weighted kappa varied from 0.3778 to 0.5217. The WHORSSTC showed a progression of malignancy risk from the category "benign" (28%) to the category "malignant" (88%). Interobserver agreement was only fair.

Performance of the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology Classification Criteria for antineutrophil cytoplasmic antibody-associated vasculitis in previously diagnosed adult patients from Türkiye.

Objectives: This study aimed to evaluate the applicability of the new 2022 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) criteria in Turkish adult patients previously diagnosed with antineutrophil cytoplasmic antibody-associated vasculitis (AAV). Patients and methods: One hundred sixty-four patients (96 males, 68 females; mean age: 49.6±14.4 years; range, 18 to 87 years) diagnosed with AAV by experienced rheumatologists between July 2016 and May 2022 were included in this retrospective cross-sectional study and reclassified based on the 1990 ACR criteria, the European Medicines Agency (EMEA) algorithm, and the 2022 ACR/EULAR criteria. For external validation, 83 patients (48 males, 35 females; mean age: 47.3±17.5 years; range, 19 to 81 years) diagnosed with immunoglobulin (Ig)A vasculitis were included. Results: One hundred twenty-six (76.8%) patients had granulomatosis with polyangiitis (GPA), 13 (7.9%) patients had eosinophilic granulomatosis with polyangiitis (EGPA), and 25 (15.2%) patients had microscopic polyangiitis (MPA). According to the criteria, the number of unclassified patients was nine (5.5%) for both the 2022 ACR/EULAR AAV classification criteria and the EMEA algorithm. The new criteria had an almost perfect agreement with the clinician's diagnosis (Cohen's kappa coefficient [κ]=0.858 for GPA, κ=0.820 for EGPA, and κ=0.847 for MPA). The kappa statistics for agreement of 2022 ACR/EULAR classification criteria with the EMEA algorithm were found 0.794 for GPA, 0.820 for EGPA, and 0.700 for MPA. None of the 83 patients diagnosed with IgA vasculitis could be classified as GPA, EGPA, or MPA using the new ACR/EULAR AAV classification criteria. Conclusion: The 2022 ACR/EULAR classification criteria for AAV showed substantial or perfect agreement with the clinical diagnosis and the EMEA algorithm.

Validation of Vascular Location Subcodes for Acute Ischemic Stroke by the International Classification of Diseases-10

BackgroundVascular region of infarct is part of the International Classification of Diseases-10 (ICD-10) coding scheme for ischemic stroke. These data could potentially be used for studies about vascular location, such as comparisons of anterior versus posterior circulation stroke. The objective of this study was to evaluate the validity of these subcodes. MethodsWe selected a random sample of 100 hospitalizations specifying 50 with anterior circulation ICD-10 ischemic stroke (carotid, anterior cerebral artery [CA], middle CA) and 50 with posterior circulation stroke (vertebral, basilar, cerebellar, posterior CA). The gold standard primary vascular distribution was scored using imaging studies and reports, blinded to the subcode. We compared gold-standard distribution to coded distribution and calculated the operating characteristics of ICD-10 posterior circulation versus anterior circulation codes with the gold standard. We also calculated the kappa statistic for agreement across all 7 vascular regions. ResultsIn our population of 100 strokes, mean NIHSS was 8 (SD, 8). Head CT was performed in 95 % (95/100) and MRI in 77 % (77/100). The gold standard classified 55 primary posterior circulation strokes (26 PCA, 16 cerebellar, 8 basilar, 5 vertebral), 44 primary anterior circulation strokes (35 MCA, 6 carotid, 3 ACA), and 1 stroke with no infarct on imaging. The accuracy of the ICD-10 classification for primary posterior circulation stroke versus anterior circulation/no infarct was: sensitivity 89 % (49/55); specificity 98 % (44/45); positive predictive value 98 % (49/50); negative predictive value 88 % (44/50). The reliability of the 7-region classification was excellent (kappa 0.85). ConclusionsWe found that ICD-10 classification of vascular location in routine practice correlates strongly with gold-standard localization for hospitalized ischemic stroke and supports validity in differentiating posterior versus anterior circulation. At a more granular vascular level, the location reliability was excellent, although limited data were available for some subcodes.

Comparison of the Automated OvaCyte Telenostic Faecal Analyser versus the McMaster and Mini-FLOTAC Techniques in the Estimation of Helminth Faecal Egg Counts in Equine.

Gastrointestinal helminth parasites continue to be a significant threat to the health of equine. OvaCyte Telenostic (OCT) (Telenostic Ltd., Kilkenny, Ireland) has developed an automated digital microscope utilising Artificial Intelligence to identify and count the clinically important helminth species in equine, bovine, and ovine host species. In this paper, the performance of the OCT analyser was evaluated for the detection and counting of equine helminth species parasites and its performance compared to the currently accepted benchmark methods of faecal egg counts being the McMaster and the Mini-FLOTAC techniques. A pairwise comparison of tests was assessed based on the correlation of egg counts and Cohen's kappa agreement statistics for dichotomized outcomes. Bayesian latent class analysis was used to estimate the sensitivity and specificity of all three techniques in the absence of a gold standard for four helminth parasites (strongyles, Anoplocephala spp., Parascaris spp. and Strongyloides westeri). Based on the analysis of 783 equine faecal samples, we found a high level (ρ ≥ 0.94) of correlation between each pairwise comparison of techniques for strongyle egg counts. Cohen's kappa agreement between techniques was high for strongyles and S. westeri, moderate for Parascaris spp., and low for Anoplocephala spp. All three techniques had a high sensitivity and specificity (>0.90) for strongyles. Across helminth parasites, the sensitivity of the OCT was the highest of the three techniques evaluated for strongyles (0.98 v 0.96 and 0.94), Anoplocephala spp. (0.86 v 0.44 and 0.46) and Parascaris spp. (0.96 v 0.83 and 0.96); but lowest for S. westeri (0.74 v 0.88 and 0.88), compared to McMaster and Mini-FLOTAC, respectively. In terms of specificity, OCT was the lowest in two species (Parascaris spp. 0.96, Anoplocephala spp. 0.95). In conclusion, OCT has a sensitivity and specificity statistically similar to both McMaster and Mini-FLOTAC, and had a higher correlation with Mini-FLOTAC. The OCT point of care faecal analyser offers improved workflow, test turn-around time and does not require trained laboratory personnel to operate or interpret the results.

Metabarcoding using nanopore long-read sequencing for the unbiased characterization of apicomplexan haemoparasites.

Apicomplexan haemoparasites generate significant morbidity and mortality in humans and other animals, particularly in many low-to-middle income countries. Malaria caused by Plasmodium remains responsible for some of the highest numbers of annual deaths of any human pathogen, whilst piroplasmids, such as Babesia and Theileria can have immense negative economic effects through livestock loss. Diagnosing haemoparasites via traditional methods like microscopy is challenging due to low-level and transient parasitaemia. PCR-based diagnostics overcome these limitations by being both highly sensitive and specific, but they may be unable to accurately detect coinfections or identify novel species. In contrast, next-generation sequencing (NGS)-based methods can characterize all pathogens from a group of interest concurrently, although, the short-read platforms previously used have been limited in the taxonomic resolution achievable. Here, we used Oxford Nanopore Technologies' (ONT) long-read MinION™ sequencer to conduct apicomplexan haemoparasite metabarcoding via sequencing the near full-length 18S ribosomal RNA gene, demonstrating its ability to detect Babesia, Hepatozoon, Neospora, Plasmodium, Theileria and Toxoplasma species. This method was tested on blood-extracted DNA from 100 dogs and the results benchmarked against qPCR and Illumina-based metabarcoding. For two common haemoparasites, nanopore sequencing performed as well as qPCR (kappa agreement statistics > 0.98), whilst also detecting one pathogen, Hepatozoon felis, missed by the other techniques. The long-reads obtained by nanopore sequencing provide an improved species-level taxonomic resolution whilst the method's broad applicability mean it can be used to explore apicomplexan communities from diverse mammalian hosts, on a portable sequencer that easily permits adaptation to field use.

Assessment of early diabetic retinopathy severity using ultra-widefield Clarus versus conventional five-field and ultra-widefield Optos fundus imaging

To compare early diabetic retinopathy (DR) severity level and the abilities in detecting early DR lesions among conventional five-field, ultrawide-field (UWF) Optos, and UWF Clarus fundus imaging methods. This was a single-center, prospective, clinic-based, and comparative study. In total, 157 consecutive patients with diabetes mellitus were enrolled in this study. All patients underwent comprehensive ophthalmological examinations. Following mydriasis, each eye was examined with conventional five-field, UWF Optos, and UWF Clarus fundus imaging methods. The initial UWF images were overlaid with a template mask that obscured the retina, which created a five-field view from UWF images (covered UWF images). The covered UWF images were then graded, after which the template mask was removed, and the original UWF images were also evaluated. All images were graded using the International Clinical DR severity scale. DR grades were compared and analyzed by weighted kappa statistics among the three fundus imaging methods. In total, 157 consecutive patients with diabetes (302 eyes) were enrolled in this study. Weighted kappa statistics for agreement were 0.471 (five-field vs. covered Optos), 0.809 (five-field vs. covered Clarus), 0.396 (covered Optos vs. covered Clarus), 0.463 (five-field vs. Optos), 0.521 (five-field vs. Clarus 133°), 0.500 (five-field vs. Clarus 200°), 0.323 (Optos vs. Clarus 133°), and 0.349 (Optos vs. Clarus 200°). The area under curve of covered Clarus images was higher than that of conventional five-field images at three different thresholds. Compared with conventional five-field and Optos fundus imaging methods, Clarus fundus imaging methods exhibited excellent performance in assessing early DR severity. Thus, Clarus fundus imaging methods were superior for early detection of DR.

THU203 Self-puberty Staging In Endocrine Encounters During The COVID Pandemic

Abstract Disclosure: C. Ebo: None. J. McCray: None. K. Bowers: None. S.R. Rose: None. N. Yayah Jones: None. Background and Objective: Telemedicine became increasingly necessary during the COVID 19 pandemic. It presents challenges for evaluating pubertal staging, essential for endocrine care. Studies testing validity of pubertal self-staging compared with clinical examination have had conflicting results and have not focused on telemedicine encounters. The aim of this study was to determine validity and reliability of patients’ self-staging pubertal assessments for potential use at home during telemedicine visits. Methods: Study included patients [referred to Cincinnati Children Hospital Medical Center pediatric endocrinology center for specialty care], age 7-22y, who required pubertal staging as part of their comprehensive evaluation. Upon clinic check-in, patients received a packet with description of study procedure and rationale; an option to “opt in” or “opt out” of the study; written sex-specific instructions on how to do self-pubertal staging; and gender-appropriate illustration sheet(s) depicting Tanner (T) stages. Boys’ packets included drawings and descriptions for pubic hair (PH) stages T1-T5; girls’ packets included drawings and descriptions for PH and also for breast development (BR) stages T1-T5. Patients who “opted in” were given <10 minutes alone in their clinic room to choose the image(s) that most resembled their bodies. Their selection went in a sealed envelope. Patients then underwent their clinic visit with physical examination by a board-certified pediatric endocrinologist including BR staging for girls, assessment of testicular size in boys, and PH staging in both sexes. Results: We received 243 self-assessments (51.4% girls), of which 80% were complete with self- and endocrinologist staging (48.0% girls). Mean age of participants was 12.8y. Mean BMI was 22.2 kg/m2 (boys), 23.7 (girls). Hypothyroidism was the most common endocrine diagnosis among participants. We calculated a Tanner stage kappa statistic for agreement with the endocrinologist with 95%CI for BR/PH by sex. Kappa >0.60 was considered strong agreement; 0.40-0.60 moderate agreement; 0.20-0.40 fair agreement. Agreement for girls was highest in T1 (BR 0.65, 95%CI 0.44-0.86; PH 0.57, 95%CI 0.35-0.79) and T5 (BR 0.57, 95%CI 0.37-0.77; PH 0.65, 95%CI 0.47-0.83). Agreement for boys PH was highest in T1 (0.73, 95%CI 0.59-0.87) and T2 (0.58, 95%CI 0.59-0.87). A greater level of agreement was found when female (F) and male (M) T stages were grouped by pre-puberty (T1; BR 0.65, FPH 0.57, MPH 0.73), early-mid puberty (T2-3; BR 0.60, FPH 0.52, MPH 0.59), and late puberty (T4-5; BR 0.76, FPH 0.74, MPH 0.79). Conclusion: Using self-staging of puberty, children and adolescents can distinguish between "puberty" and "no puberty", although differentiating between later pubertal stages is less reliable. These results contribute to defining utility and limitations of self-staging during telemedicine visits. Presentation: Thursday, June 15, 2023

Evaluation of the Completeness of Managed Care Data to Identify Cancer Diagnoses and Treatments for Patients in the SEER-Medicare Data.

The utility of codes on Medicare Advantage (MA) data to capture cancer diagnoses and treatment for cancer patients is unknown. This study compared cancer diagnoses and treatments on MA encounter data (MA data) with the Surveillance, Epidemiology, and End-Results (SEER) data. Subjects were patients enrolled in either MA or Medicare fee-for-service (MFFS) when diagnosed with incident breast, colorectal, prostate, or lung cancer, 2015-2017, in a SEER cancer registry. MA data, from 2 months before to 12 months following SEER diagnosis, were reviewed to identify cancer diagnoses, surgery, chemotherapy, and radiotherapy (RT). MA data were compared with SEER to determine their sensitivity to capture cancer diagnoses and sensitivity/specificity to identify surgeries. The agreement between SEER and Medicare data regarding receipt of chemotherapy and RT was measured by Kappa statistics. A similar comparison to SEER diagnoses/treatments was made using MFFS claims to provide context for the SEER-MA comparison. The study included 186,449 patients, 38% in MA. MA data had 92%+ sensitivity to identify SEER cancer diagnosis and 90%+ sensitivity for cancer surgery. Specificity for surgery was >84%, except for breast cancer (52%). Kappa statistics for agreement between SEER and MA data regarding chemotherapy varied by cancer, 0.61-0.82, and for receipt of RT exceeded 0.75 for all cancers. Results observed for MFFS claims were similar to those in MA data. For 4 common cancers, MA data included most cancer diagnoses and general types of cancer treatment reported in the SEER data. More research is needed to assess additional cancers and detailed treatments.

Feasibility of screening for cognitive impairment among older persons and referral by community health workers in Wakiso district, Uganda.

In Uganda, cognitive impairment in older persons aged ≥ 60 years is often undiagnosed due to inadequate appreciation of the condition compounded with limitations of trained human resource able to conduct appropriate cognitive evaluations. Use of Community Health Workers (CHWs) especially in hard-to-reach communities can be an important link for older persons to the health facilities where they can receive adequate evaluations and interventions for cognitive challenges. The aim of the study was to assess the feasibility of screening for cognitive impairment among older persons and referral by CHWs in Wakiso district, Uganda. This was a sequential explanatory mixed methods study. The CHWs received a one-day training on causes, signs and symptoms, and management of cognitive impairment and screened older persons ≥ 60 years for cognitive impairment using the Alzheimer's Disease scale 8 (AD8). Psychiatric clinical officers (PCOs) administered the AD8 and the Mini Mental State Examination to the older persons after assessment by the CHWs who then referred them for appropriate clinical care. We conducted Kappa statistic for agreement between the CHWs and PCOs and compared raw scores of the CHWs to Experts scores using Bland Altman and pair plots and corresponding analyses. We also conducted focus group discussions for the older persons, caregivers and CHWs. We collected data from 385 older persons. We involved 12 CHWs and 75% were females, majority were married (58.3%) with at least a secondary education (66.7%). There was 96.4% (CI 94.5-98.2%) agreement between PCOs and CHWs in identifying cognitive impairment with the PCOs identifying 54/385 (14.0: 95%CI 10.7-17.9%) older persons compared to 58/385 (15.1: 95%CI 11.6-19.0%) identified by CHWs. Of the 58 identified to have cognitive impairment by the CHWs, 93.1% were referred for care. The average difference between the score of the expert and that of the CHW was - 0.042 with a 95% CI of -1.335 to 1.252. Corresponding Bland Altman and pair plots showed high agreement between the measurements although CHWs scored higher values with increasing scores. CHWs can be trained to identify and refer older persons with cognitive impairment in the communities.

Visual diagnosis of female genital schistosomiasis in Zambian women from hand-held colposcopy: agreement of expert image review and association with clinical symptoms.

Background:Female genital schistosomiasis (FGS) can occur in S. haematobiuminfection and is caused by egg deposition in the genital tract. Confirming a diagnosis of FGS is challenging due to the lack of a diagnostic reference standard. A 2010 expert-led consensus meeting proposed visual inspection of the cervicovaginal mucosa as an adequate reference standard for FGS diagnosis. The agreement of expert human reviewers for visual-FGS has not been previously described. Methods: In two Zambian communities, non-menstruating, non-pregnant, sexually-active women aged 18-31 years participating in the HPTN 071 (PopART) Population-Cohort were enrolled in a cross-sectional study. Self-collected genital swabs and a urine specimen were collected at a home visit; trained midwives performed cervicovaginal lavage (CVL) and hand-held colposcopy at a clinic visit. S. haematobiumeggs and circulating anodic antigen (CAA) were detected from urine. Twosenior physicians served asexpert reviewers and independently diagnosed visual-FGS as the presence of sandy patches, rubbery papules or abnormal blood vessels in cervicovaginal images obtained by hand-held colposcopy. PCR-FGS was defined as SchistosomaDNA detected by real-time PCR in any genital specimen (CVL or genital swab). Results: Of 527 women with cervicovaginal colposcopic images, 468/527 (88.8%) were deemed interpretable by Reviewer 1 and 417/527 (79.1%) by Reviewer 2. Visual-FGS was detected in 35.3% (165/468) of participants by expert review of colposcopic images by Reviewer 1 and in 63.6% (265/417) by Reviewer 2.Cohen's kappa statistic for agreement between the two reviewers was 0.16, corresponding to "slight" agreement. The reviewers made concordant diagnoses in 38.7% (204/527) participants (100 negative, 104 positive) and discordant diagnoses in 31.8% (168/527) participants. Conclusions:The unexpectedly low level of correlation between expert reviewers highlights the imperfect nature of visual diagnosis for FGS based on cervicovaginal images. This finding is a call to action for improved point-of-care diagnostics for female genital schistosomiasis.

Visual diagnosis of female genital schistosomiasis in Zambian women from hand-held colposcopy: agreement of expert image review.

Female genital schistosomiasis (FGS) can occur in S. haematobium infection and is caused by parasite egg deposition in the genital tract. Confirming a diagnosis of FGS is challenging due to the lack of a diagnostic reference standard. A 2010 expert-led consensus meeting proposed visual inspection of the cervicovaginal mucosa as an adequate reference standard for FGS diagnosis. The agreement of expert human reviewers for visual-FGS has not been previously described. Methods: In two Zambian communities, non-menstruating, non-pregnant, sexually-active women aged 18-31 years participating in the HPTN 071 (PopART) Population-Cohort were enrolled in a cross-sectional study. Self-collected genital swabs and a urine specimen were collected at a home visit; trained midwives performed CVL and hand-held colposcopy at a clinic visit. S. haematobium eggs and circulating anodic antigen (CAA) were detected from urine. Two expert reviewers independently diagnosed visual-FGS as the presence of sandy patches, rubbery papules or abnormal blood vessels in digital cervicovaginal images obtained by hand-held colposcopy. PCR-FGS was defined as Schistosoma DNA detected by real-time PCR in any genital specimen (CVL or genital swab). Results: Of 527 women with cervicovaginal colposcopic images, 468/527 (88.8%) were deemed interpretable by Reviewer 1 and 417/527 (79.1%) by Reviewer 2. Visual-FGS was detected in 35.3% (165/468) of participants by expert review of colposcopic images by Reviewer 1 and in 63.6% (265/417) by Reviewer 2. Cohen's kappa statistic for agreement between the two expert reviewers was 0.16, corresponding to "slight" agreement. The reviewers made concordant diagnoses in 38.7% (204/527) participants (100 negative, 104 positive) and discordant diagnoses in 31.8% (168/527) participants. Conclusions: The unexpectedly low level of correlation between expert reviewers highlights the imperfect nature of visual diagnosis for FGS based on cervicovaginal images obtained with a hand-held colposcope. This finding is a call to action for improved point-of-care diagnostics for female genital schistosomiasis.

Validation of the Korean Ankylosing Spondylitis Quality of Life Questionnaire.

Measuring accurate and reliable scores of quality of life in patients with ankylosing spondylitis (AS) is important in both decision-making and treatment planning for the disease. Questionnaire, The ankylosing spondylitis quality of life (ASQoL), is one of the representative tools for assessing how seriously AS patients view their disease severity, activity, as well as their overall health. To make these types of questionnaires readable and understandable, local language translation of surveys should be required. A Korean version of the ASQoL questionnaire has accordingly been developed. This study assessed the Korean version of the ASQoL survey to evaluate the reliability and validity of it. Translation and reverse translation of the English ASQoL survey were conducted. A total of 120 consecutive AS patients received a mail including the Korean-translated 36-Item Short Form Survey (SF-36), the ASQoL survey, and the visual analog scale (pain). The coefficient of intraclass correlation and Cronbach's alpha were computed, and factor analysis, as well as reliability assessments utilizing the kappa agreement statistics for each item, was undertaken. By analyzing the responses to SF-36 and ASQoL questionnaire utilizing Pearson's correlation coefficient, construct validity was calculated. Factor analysis was performed regarding pain, physical function, and mental function. The kappa statistic of agreement was larger than 0.6 for all items. The ASQoL questionnaire had adequate test and re-test reliability (0.814). Furthermore, Cronbach'sα, the internal consistency, was very good (0.877). The Korean-translated ASQoL questionnaire demonstrated a significantly strong correlation between the single domain and total SF-36 scores. The Korean version of the ASQoL questionnaire showed acceptable properties of measurement and successful translation. Thus, it can be said that the questionnaire is appropriate for evaluating the outcomes of Korean patients with AS.

P003: A retrospective study to evaluate the reliability of staging and risk stratification of adolescent and adult patients with Hodgkin’s lymphoma registered in the lymphoma clinic at Tata Memorial Centre.

Table 1: Baseline characteristics Purpose: Risk stratification is a key factor,which depends on staging, clinical and laboratory parameters in determining the treatment in Hodgkin’s lymphoma (HL). However, this is highly prone to erroneous results due to overlapping components in the staging systems and inter-observer variability.We conducted this study to assess the reliability of risk stratification performed by our clinicians at our busy multidisciplinary clinic (MDC). Methods: A retrospective analysisof newly diagnosed HL patients from the multidisciplinary clinic database for the year 2016-18was conducted.All patients underwent an 18-FDG PET/CT scan and other evaluations as per our institutional checklist. The reliability of staging and risk stratification done during the MDC was compared with a team of independent experts (medical oncology, radiation oncology and nuclear medicine) based on a standard reference. The concordance testing was done using kappa statistic for agreement (≥ 0.8 as perfect agreement) andP <0.05 was considered significant. Results: 120 patients were analyzed, and the baseline characteristics are described in Table 1. The patients initially underwent staging by MDC and were risk stratified into early favorable (16 patients [13.5%]), early unfavorable (29 patients [24%]) and advanced (75 patients [62.5%]). A discordance rate of 10% (12 patients) was observed in disease staging and 8.3% in risk stratification (10 patients) between the MDC and the expert team. All deviations were due to up-staging of patients by MDC, of which 9 patients in early favorable were misclassified as early unfavorable and 1 patient as advanced from early unfavorable. This resulted in 10 patients receiving higher dose of chemotherapy and radiation. However, no patients were under treated. On completion of treatment, 82%of patientshadcomplete response, 12%had partial responseand 5%had disease progression. Our results show that the discordance rates were not significantbetween the independent reviewers and MDC team with kappa score of 0.859 for stagingand 0.847 for risk stratification. Conclusion: Despite our busy setting, the risk stratification was found to be reliable and comparable to reference standards. One reason for this would be the involvement of a multidisciplinary team in our lymphoma clinic. Yet, 8% of the patients received a more intense therapy than needed, demonstrating the need for a simpler, objective and technology driven risk stratification process.

S7.1d Reliability of bedside point-of-care tests for Candida neoformans , M. tuberculosis and S. pneumoniae in adults living with HIV presenting with suspected central nervous system infection (CNS) in low- and middle-income settings: Preliminary results from the DREAMM study

S7.1 Update in management of fungal infection in adult hematology, September 23, 2022, 10:30 AM - 12:00 PMBackgroundBedside point-of-care (POC) testing, with parallel laboratory testing, represents a unique opportunity to improve and speed up the diagnostic workup of people living with HIV with suspected CNS infection in resource-limited settings.ObjectivesTo assess the agreement between POC tests for Cryptococcus neoformans, Mycobacterium tuberculosis, and Streptococcus pneumoniae performed at the bedside and in the routine laboratory, in African low- and middle-income countries (LMICs).MethodsFrom January 2018 to March 2021, the following POC tests were performed in parallel at the bedside and in the routine laboratory: Cryptococcal antigen lateral flow assay (CrAg LFA, Immy) in blood and cerebrospinal fluid (CSF), tuberculosis lipoarabinomannan (TB-LAM, Alere) in urine, and, where indicated, pneumococcal antigen (Streptococcus pneumoniae (SP), Biosynex) in CSF.Participants: HIV-infected adults (>18 years old) suspected of CNS infection.Setting: The prospective multicenter DREAMM project (Driving Reduced AIDS Meningo-Encephalitis Mortality) in five hospital sites in Cameroon, Malawi, and Tanzania.Primary outcome: Cohen's kappa statistic of agreement between the results of POC tests obtained at the bedside and the routine laboratory.ResultsThe study included 356 consecutive participants (mean age 39.5 +/- 10 years; 68.7% ART-experienced; 46.3% male; median CD4 count 75/mm3; abnormal mental status 75%). In total, 148/355 (41.7%) participants had positive bedside CrAg in blood, 140/315 (44.4%) positive bedside CrAg in CSF, 64/339 (18.9%) positive bedside TB-LAM in urine, and 10/175 (5.7%) positive bedside SP in CSF. Kappa statistics evaluating agreement between bedside and laboratory test results were: 0.98 [95% confidence interval (CI) 0.96-1.00; n = 347] for blood CrAg, 0.99 (95%CI, 0.98-1.00; n = 307) for CSF CrAg, 0.92 (95% CI, 0.87-0.98; n = 330) for urinary TB-LAM, and 0.68 (95%CI, 0.40-0.96; n = 34) for CSF SP.ConclusionsBedside POC tests for Cryptococcus spp. are highly reliable and can be safely performed in parallel to laboratory testing to expedite targeted treatment in people living with HIV with suspected CNS infection in African LMICs. Other bedside POC tests need further evaluation before large-scale implementation.

Minimal residual disease comparison between Ig/TCR PCR versus NGS assays in children with Philadelphia chromosome-positive acute lymphoblastic leukemia: A report from the COG AALL1631 study.

10023 Background: Minimal residual disease (MRD) assessment by immunoglobulin/T-cell receptor (Ig/TCR) polymerase chain reaction (PCR) is currently being used in the international pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) trial EsPhALL2017/AALL1631 for risk stratification. MRD concordance has previously been demonstrated between Ig/TCR PCR and flow cytometry in Ph+ALL. We sought to assess concordance of MRD assessment between conventional Ig/TCR PCR and next-generation sequencing (NGS) assays. Methods: MRD was assessed in all pts on AALL1631 by Ig/TCR PCR at end-induction IB; those with MRD &lt;5x10-4 were classified as standard-risk (SR) and randomized to treatment with imatinib and one of two chemotherapy regimens without hematopoietic stem cell transplant (HSCT), whereas pts with end-induction 1B MRD ≥ 5x10-4 were considered high-risk (HR) and assigned to HSCT after consolidation chemotherapy. Residual diagnostic and end-induction IB samples from consenting pts were assessed for NGS MRD by the clonoSEQ assay (Adaptive Biotechnologies) in blinded fashion and subsequently compared to Ig/TCR MRD to determine concordance as related to MRD-based HSCT recommendations ( ie, MRD ≥ 5x10-4 consistent with HR group assignment). MRD values were calculated using the kappa statistic for agreement above chance. Results: Sixty-seven pts had matched samples available for MRD assessment at end-induction 1B by both Ig/TCR PCR and NGS (Table). NGS MRD was evaluable for all 67 pts and stratified as 62 SR (&lt;5x10-4) and 5 HR (≥5x10-4). In contrast, Ig/TCR PCR results were inevaluable for 3 pts (unsatisfactory sample quality) and indeterminate (positive, but not quantifiable) in 4 pts. Of the remaining 60 pts, 55 met SR and 5 HR criteria using Ig/TCR PCR. There was only 1 discordant case between the two methods for MRD-based HSCT recommendation among these 60 pts with a kappa statistic for agreement above chance of 0.88. Conclusions: NGS and Ig/TCR PCR assays were highly concordant in MRD assessment for risk stratification at a threshold of 5x10-4 in pediatric pts with Ph+ALL enrolled on AALL1631. Of note, the NGS assay yielded MRD results amenable for risk stratification in 100% pts compared to 89.6% for the Ig/TCR PCR methodology. These data support the use of NGS MRD testing for risk stratification in pediatric Ph+ALL.[Table: see text]