Diagnostic Validity Research Articles

Identifying and Validating Alcohol Diagnostics for Injury-Related Trauma in South Africa: Protocol for a Mixed Methods Study.

The burden of alcohol use among patients with trauma and the relative injury risks is not routinely measured in South Africa. Given the prominent burden of alcohol on hospital trauma departments, South Africa needs practical, cost-effective, and accurate alcohol diagnostic tools for testing, surveillance, and clinical management of patients with trauma. This study aims to validate alcohol diagnostics for injury-related trauma and assess its use for improving national health practice and policy. The Alcohol Diagnostic Validation for Injury-Related Trauma study will use mixed methods across 3 work packages. Five web-based focus group discussions will be conducted with 6 to 8 key stakeholders, each across 4 areas of expertise (clinical, academic, policy, and operational) to determine the type of alcohol information that will be useful for different stakeholders in the injury prevention and health care sectors. We will then conduct a small pilot study followed by a validation study of alcohol diagnostic tools (clinical assessment, breath analysis, and fingerprick blood) against enzyme immunoassay blood concentration analysis in a tertiary hospital trauma setting with 1000 patients. Finally, selected alcohol diagnostic tools will be tested in a district hospital setting with a further 1000 patients alongside community-based participatory research on the use of the selected tools. Pilot data are being collected, and the protocol will be modified based on the results. Through this project, we hope to identify and validate the most appropriate methods of diagnosing alcohol-related injury and violence in a clinical setting. The findings from this study are likely to be highly relevant and could influence our primary beneficiaries-policy makers and senior health clinicians-to adopt new practices and policies around alcohol testing in injured patients. The findings will be disseminated to relevant national and provincial government departments, policy experts, and clinicians. Additionally, we will engage in media advocacy and with our stakeholders, including community representatives, work through several nonprofit partners to reach civil society organizations and share findings. In addition, we will publish findings in scientific journals. DERR1-10.2196/52949.

Diagnostic accuracy validation study of the M6 model without initial serum progesterone (M6NP) in triage of pregnancy of unknown location

ObjectivesThe M6 prediction model stratifies the risk of development of ectopic pregnancy (EP) for women with pregnancy of unknown location (PUL) into low risk or high risk, using human chorionic gonadotrophin (hCG) and progesterone levels at the initial visit to a gynaecological emergency room and hCG level at 48 h. This study evaluated a second model, the M6NP model, which does not include the progesterone level at the initial visit. The main aim of this study was to validate the diagnostic accuracy of the M6NP model in a population of French women. Study designBetween January and December 2021, all women with an hCG measurement from the gynaecological emergency department of a teaching hospital were screened for inclusion in this study. Women with a pregnancy location determined before or at the second visit were excluded. The diagnostic test was based on logistic regression of the M6NP model, with classification into two groups: high risk of EP (≥5%) and low risk of EP (<5%). The reference test was the final outcome based on clinical, biological and sonographic results: failed PUL (FPUL), intrauterine pregnancy (IUP) or EP. Diagnostic performance for risk prediction of EP, and also IUP and FPUL, was calculated. ResultsIn total, 759 women with possible PUL were identified. After screening, 341 women with PUL were included in the main analysis. Of these, 186 (54.5%) were classified as low risk, including three (1.6%) with a final outcome of EP. The remaining 155 women with PUL were classified as high risk, of whom 60 (38.7%), 66 (42.8%) and 29 (18.7%) had a final outcome of FPUL, IUP and EP, respectively. Of the 32 women with PUL with a final outcome of EP, 29 (90.6%) were classified as high risk and three (9.4%) were classified as low risk. Therefore, the performance of the M6NP model to predict EP had a negative predictive value of 98.4%, a positive predictive value of 18.7%, sensitivity of 90.6% and specificity of 59.2%. If the prediction model had been used, it is estimated that 4.5 visits per patient could have been prevented. ConclusionThe M6NP model could be used safely in the French population for risk stratification of PUL. Its use in clinical practice should result in a substantial reduction in the number of visits to a gynaecological emergency room.

Diagnostic performance evaluation of urine HIV-1 antibody rapid test kits in a real-life routine care setting in China

ObjectivesTo evaluate the diagnostic performance of urine HIV antibody rapid test kits in screening diverse populations and to analyse subjects’ willingness regarding reagent types, purchase channels, acceptable prices, and self-testing.DesignsDiagnostic...

Factors Associated with Nutritional Risk Assessment in Critically Ill Patients Using the Malnutrition Universal Screening Tool (MUST).

Background: Malnutrition is an underdiagnosed condition that negatively affects the clinical outcomes of patients, being associated with an increased risk of adverse events, increased hospital stay, and higher mortality. Therefore, nutritional assessment is a required and necessary process in patient care. The objective of this study was to identify the factors associated with nutritional risk by applying the Malnutrition Universal Screening Tool (MUST) scale in a population of critically ill patients. Methods: This was an observational, analytical, and retrospective study. Sociodemographic, clinical, hematological, and biochemical variables and their relationship with nutritional risk and mortality were analyzed. Results: Of 630 patients, the leading cause of admission was pathologies of the circulatory and respiratory system (50%); 28.4% were at high nutritional risk; and mortality was 11.6% and associated with nutritional risk, hemoglobin, and plasma urea nitrogen. Conclusions: The presence of gastrointestinal symptoms and the type of nutritional support received during hospitalization could increase the likelihood of presenting a medium/high nutritional risk, while polycythemia reduced this probability. An associative model was found to determine nutritional risk with an adequate specificity and diagnostic validity index.

Obsessive-Compulsive Disorder as an Epiphenomenon of Comorbid Bipolar Disorder? An Updated Systematic Review.

Bipolar disorder (BD) and obsessive-compulsive disorder (OCD) comorbidity is an emerging condition in psychiatry, with relevant nosological, clinical, and therapeutic implications. We updated our previous systematic review on epidemiology and standard diagnostic validators (including phenomenology, course of illness, heredity, biological markers, and treatment response) of BD-OCD. Relevant papers published until (and including) 15 October 2023 were identified by searching the electronic databases MEDLINE, Embase, PsychINFO, and Cochrane Library, according to the PRISMA statement (PROSPERO registration number, CRD42021267685). We identified 38 new articles, which added to the previous 64 and raised the total to 102. The lifetime comorbidity prevalence ranged from 0.26 to 27.8% for BD and from 0.3 to 53.3% for OCD. The onset of the two disorders appears to be often overlapping, although the appearance of the primary disorder may influence the outcome. Compared to a single diagnosis, BD-OCD exhibited a distinct pattern of OC symptoms typically following an episodic course, occurring in up to 75% of cases (vs. 3%). Notably, these OC symptoms tended to worsen during depressive episodes (78%) and improve during manic or hypomanic episodes (64%). Similarly, a BD course appears to be chronic in individuals with BD-OCD in comparison to patients without. Additionally, individuals with BD-OCD comorbidity experienced more depressive episodes (mean of 8.9 ± 4.2) compared to those without comorbidity (mean of 4.1 ± 2.7). We found a greater likelihood of antidepressant-induced manic/hypomanic episodes (60% vs. 4.1%), and mood stabilizers with antipsychotic add-ons emerging as a preferred treatment. In line with our previous work, BD-OCD comorbidity encompasses a condition of greater nosological and clinical complexity than individual disorders.

Clinical Endocrinology-Time for a Reset?

Measurement of blood levels of circulating hormones has always been the cornerstone of the biochemical diagnosis of endocrine diseases, with the objective of detecting hormone excess or insufficiency. Unfortunately, the dynamic nature of hormone secretion means single-point measurements of many hormones often lack diagnostic validity. Endocrinologists have devised complex dynamic tests as indirect assessments of the functioning of the hormone system under investigation. Recent advances in the measurement of dynamic hormone changes across the day now offer an opportunity to reconsider whether there might be better ways both to diagnose and to monitor the therapy of endocrine conditions.

Adapting the Dietary Fat and Free Sugar Short Questionnaire: A Comprehensive Polish Modification for Enhanced Precision in Nutritional Assessments.

This study aimed to investigate whether The Dietary Fat and Free Sugar-Short Questionnaire (DFS) is a reliable and valid measure that can be used in Polish conditions. It involved 291 participants, aged 14 to 70 (M = 25.9, SD = 10.1), the majority of whom were women (75%). The questionnaire consisted of, among others, Polish DFS version, FFQ-6, TFEQ, and SCOFF. Test-retest reliability was established on the group of 26 students with a 2-week interval. Participants' percentage of energy intake from both free sugars and saturated fats based on FFQ was correlated with DFS total and subscales scores. To investigate convergent and divergent validity, DFS scores with TFEQ correlations were performed. Diagnostic validity was established based on difference analysis between groups with the risk of eating disorders and those without the risk of those based on SCOFF. Test-retest reliability (rtr = 0.856) and internal consistency (α = 0.797) indicated excellent reliability. DFS correlated significantly with FFQ for both total scores (r = 0.82) and each subscale: sugar (0.79), fat (0.75), and fat-sugar (0.59). The correlations of DFS and TFEQ were statistically significant for cognitive restraint (r = 0.32) and uncontrolled eating (r = 0.19). There also have been found significant differences based on SCOFF regarding DFS. The results suggest good reliability and validity of the Polish version of DFS.

Spanish transcultural adaptation of the 4AT score for the evaluation of delirium in the emergency department: a prospective diagnostic test accuracy study

BackgroundDelirium is one of the most common adverse events in older people during hospitalization, especially in the emergency department. Reliable, easy-to-use instruments are necessary to properly manage delirium in this setting. This study aims to evaluate the diagnostic validity of the Spanish version of the 4 ‘A’s Test (4AT) in the ED.MethodsA diagnostic accuracy study was conducted in patients over 65 years old admitted to the Emergency Department who did not have a formal diagnosis of dementia or a severe mental health disorder. Face and content validity were evaluated by an expert panel. Emergency nurses performed the evaluation with 4AT, whilst blinded and trained researchers assessed patients with the Revised Delirium Rating Scale as the gold standard. The content validity index, sensitivity, specificity, positive and negative predictive values, likelihood ratios, Youden’s Index and ROC curves were calculated to evaluate the diagnostic accuracy of the instrument.ResultsOf 393 eligible patients, 380 were finally analyzed. Content validity yielded a median content validity index of 4 (interquartile range: 0). The Spanish 4AT sensitivity (95.83%; 95% ECI: 78.9–99.9%), specificity (92.98%; 95% CI: 89.8–95.4%), positive predictive value (47.92%) and negative predictive value (99.7%) were satisfactory. Youden’s index was 0.89. Positive likelihood ratio was 13.65, and negative likelihood ratio 0.045. The area under the curve was 0.97.ConclusionsThe Spanish version of the 4AT for use in the Emergency Departments is easy-to-use and applicable. The validation results indicate that it is a valid instrument with sufficient predictive validity to identify patients at risk of delirium in the Emergency Departments. Moreover, it is a tool that facilitates the management of an adverse event that is associated with increased mortality and morbidity.

Diagnostic validity of the fifth Integrated version of IQ scales Wechsler children in students with learning disabilities in Mazandaran province

In this Research, the "diagnostic validity of the fifth integrated version of Wechsler IQ scales for children with learning disabilities in Mazandaran province Students" has been studied. The main question of the research is whether the fifth integrated version of Wechsler Intelligence Scales for children with learning disabilities in Mazandaran province has diagnostic validity. The present research method is in the field of psychometric studies, which is a subset of the methodological research method. The research community includes all students of Mazandaran province who are studying in the first elementary school (first, second and third grade) in the 97-98 academic year and as students with learning disabilities in private and public centres under Coverage of educational-therapeutic services, consisting of 240 students with learning disabilities were selected as the sample size using purposive sampling. The measurement Instrument in this Research is the fifth integrated version of the Wechsler Children's Intelligence Scale, which has good validity and reliability. The statistical model used in the present Research to determine diagnostic validity is the confidence interval method. Finally, the research findings showed that the tests of "Digit Span Forward", " Digit Span Backward" and "sentences recall" in students with learning disabilities have diagnostic validity and can exclude students with learning disabilities from other students.

Diagnostic Validity of Chronic Kidney Disease in Health Claims Data Over Time: Results from a Cohort of Community-Dwelling Older Adults in Germany.

The validity of ICD-10 diagnostic codes for chronic kidney disease (CKD) in health claims data has not been sufficiently studied in the general population and over time. We used data from the Berlin Initiative Study (BIS), a prospective longitudinal cohort of community-dwelling individuals aged ≥70 years in Berlin, Germany. With estimated glomerular filtration rate (eGFR) as reference, we assessed the diagnostic validity (sensitivity, specificity, positive [PPV], and negative predictive values [NPV]) of different claims-based ICD-10 codes for CKD stages G3-5 (eGFR <60mL/min/1.73m²: ICD-10 N18.x-N19), G3 (eGFR 30-<60mL/min/1.73m²: N18.3), and G4-5 (eGFR <30mL/min/1.73m²: N18.4-5). We analysed trends over five study visits (2009-2019). We included data of 2068 participants at baseline (2009-2011) and 870 at follow-up 4 (2018-2019), of whom 784 (38.9%) and 440 (50.6%) had CKD G3-5, respectively. At baseline, sensitivity for CKD in claims data ranged from 0.25 (95%-confidence interval [CI] 0.22-0.28) to 0.51 (95%-CI 0.48-0.55) for G3-5, depending on the included ICD-10 codes, 0.20 (95%-CI 0.18-0.24) for G3, and 0.36 (95%-CI 0.25-0.49) for G4-5. Over the course of 10 years, sensitivity increased by 0.17 to 0.29 in all groups. Specificity, PPVs, and NPVs remained mostly stable over time and ranged from 0.82-0.99, 0.47-0.89, and 0.66-0.98 across all study visits, respectively. German claims data showed overall agreeable performance in identifying older adults with CKD, while differentiation between stages was limited. Our results suggest increasing sensitivity over time possibly attributable to improved CKD diagnosis and awareness.

RegionalMRI volumetry using NeuroQuant versus visual rating scales in patients with cognitive impairment and dementia.

The aims were to compare the novel regional brain volumetric measures derived by the automatic software NeuroQuant (NQ) with clinically used visual rating scales of medial temporal lobe atrophy (MTA), global cortical atrophy-frontal (GCA-f), and posterior atrophy (PA) brain regions, assessing their diagnostic validity, and to explore if combining automatic and visual methods would increase diagnostic prediction accuracy. Brain magnetic resonance imaging (MRI) examinations from 86 patients with subjective and mild cognitive impairment (i.e., non-dementia, n = 41) and dementia (n = 45) from the Memory Clinic at Oslo University Hospital were assessed using NQ volumetry and with visual rating scales. Correlations, receiver operating characteristic analyses calculating area under the curves (AUCs) for diagnostic accuracy, and logistic regression analyses were performed. The correlations between NQ volumetrics and visual ratings of corresponding regions were generally high between NQ hippocampi/temporal volumes and MTA (r = -0.72/-0.65) and between NQ frontal volume and GCA-f (r = -0.62) but lower between NQ parietal/occipital volumes and PA (r = -0.49/-0.37). AUCs of each region, separating non-dementia from dementia, were generally comparable between the two methods, except that NQ hippocampi volume did substantially better than visual MTA (AUC = 0.80vs. 0.69). Combining both MRI methods increased only the explained variance of the diagnostic prediction substantially regarding the posterior brain region. The findings of this study encourage the use of regional automatic volumetry in locations lacking neuroradiologists with experience in the rating of atrophy typical of neurodegenerative diseases, and in primary care settings.

Validating the Glenoid Track Concept Using Dynamic Arthroscopic Assessment.

Failure after isolated Bankart repair has led surgeons to consider when to address the Hill-Sachs lesion, which is thought to be a contributor to recurrent instability. One approach utilizes the glenoid track concept to determine whether a Hill-Sachs lesion is classified as "off-track," suggesting that the addition of a remplissage procedure may aid stability. However, the accuracy and reliability of using this approach require validation using an appropriate reference. To determine the accuracy and reliability of using the glenoid track concept against dynamic arthroscopic assessment of Hill-Sachs lesion engagement. Cohort study (diagnosis); Level of evidence, 3. A total of 49 patients undergoing arthroscopic Bankart repair surgery for recurrent traumatic anterior shoulder instability were enrolled in this diagnostic validation study. Shoulders were classified as on-track or off-track using 3-dimensional computed tomography (3DCT) and static arthroscopic measurements. These classifications were compared with dynamic arthroscopic assessment (engagement of the Hill-Sachs lesion on the anterior glenoid rim in the 'athletic position') to determine their accuracy and reliability. The 3DCT-based measurements to determine glenoid track status had a higher positive predictive value (66% vs 42%), higher specificity (47% vs 42%), and higher accuracy (65% vs 59%) compared with static arthroscopic measurements. Static arthroscopic measurements to determine glenoid track status had a higher negative predictive value (96% vs 64%) and higher sensitivity (96% vs 81%) compared with 3DCT-based measurements. Interrater reliability (Krippendorff α) was 'fair' for determining the glenoid track status using 3DCT (0.368; 95% CI, 0.217-0.519) and 'moderate' for static arthroscopic measurements (0.523; 95% CI, 0.364-0.666). Intrarater reliability (intraclass correlation coefficient [ICC] 3,k) was 'moderate' for 3DCT measurements (0.660; 95% CI, 0.444-0.798) and 'good' for static arthroscopic measurements (0.769; 95% CI, 0.629-0.862). Determining glenoid track status using either 3DCT or static arthroscopic measurements yielded moderate accuracy and reliability. Surgeons using the glenoid track concept to aid surgical decision-making in traumatic recurrent anterior shoulder instability should utilize 3DCT or static arthroscopic measurements with caution.

Diagnostic reliability and accuracy of the hydraulic contrast lift protocol in the radiographic detection of sinus lift and perforation: ex vivo randomized split-mouth study in an ovine model

ObjectivesAssessing the diagnostic reliability, validity, and accuracy of the hydraulic contrast lift protocol during transcrestal sinus floor elevation in detecting the lift and perforation of the sinus membrane before graft material application and assessing the effect of its use on the operator’s diagnostic confidence.Material and methodsA single-blind randomized split-mouth study on fresh refrigerated sheep heads. The first intervention consisted of injecting 0.5 ml iodinated contrast medium on the test side and 0.5 ml saline on the control side. In the second intervention artificial sinus membrane perforations were created followed by injecting 0.5 ml iodinated contrast medium on the test side and 0.5 ml saline on the control side. Intraoperative periapical radiographs were taken for both interventions. The resulting 40 radiographs were assessed by 10 examiners to provide interpretations and confidence ratings. The primary endpoints were diagnostic reliability, validity, accuracy, and perceived diagnostic confidence.ResultsIn the hydraulic contrast lift protocol, the detection rate was 99% for sinus elevations and 98% for perforations, the saline protocol yielded a detection rate of 28% and 20% respectively. The hydraulic contrast lift protocol demonstrated a high level of inter-rater agreement for the diagnosis of elevations (p < 0.001) and perforations (p < 0.001), strong diagnostic validity for the diagnosis of elevations (p < 0.001) and perforations (p < 0.001), high sensitivity and specificity (p < 0.001) and higher mean diagnostic confidence ratings for both interventions when compared to the saline protocol (p < 0.001). The difference between the predicted probability for correct diagnosis of the hydraulic contrast lift protocol and the saline protocol was significant (p < 0.001) for the detection of both elevations and perforations.ConclusionFollowing the hydraulic contrast lift protocol, the use of a radiographic contrast medium can reliably confirm sinus membrane lift and detect perforation during transcrestal sinus floor elevation prior to bone graft application in addition to improving the diagnostic confidence of the operator while relying on periapical radiographs.

The discursive construction of self-diagnosed “pornography addiction”

Addiction is a term recently extended to problem sexual behaviours. Proponents of pornography addiction (PA) argue that pornography is comparable to drugs in its impact on brain processes and behaviour, producing effects similar to substance abuse disorders. Critics, however, assert that PA lacks diagnostic validity, that supporting research is methodologically unsound, and that diagnosis obscures the social contexts and discursive practices in which sexual behaviours are embedded. This study investigates how self-identified pornography addicts describe their experiences and explores the implicit motives and meanings at play in this identity construction. Using a psychoanalytically informed discursive methodology, the authors analyzed interviews with 10 self-identified pornography addicts, focusing on the meaning of self-diagnosis, the process of self-labelling, and participants’ psychological investment in diagnosis. Participants perceived an enslavement to desire as central to their addiction identities. Underlying this identity work were defences and conflicts about power, gender, sexuality, and perversion, as well as histories of disturbed attachment and deprivation by parental figures. The PA diagnosis counteracted feelings of shame and allowed participants to speak more freely about their difficulties. However, it also precluded more nuanced self-understandings and identity possibilities. The article concludes with a discussion of the mental health and psychotherapeutic implications of those presenting with self-diagnosed PA.

Profiles of Autistic Youth with and Without Co-occurring Behavioral Health and Neurodevelopmental Disorders: A Latent Class Analysis.

Autism spectrum disorder (ASD) diagnosis relies on clinical observation and documentation, but the presence of comorbidities can affect diagnostic validity across clinicians and exacerbate access to timely care. This study used latent class analysis to optimize subgroup identification based on functional level and associated comorbidities using the Behavior Assessment System for Children, Third Edition (BASC-3), and Vineland Adaptive Behavior Scales, Third Edition (Vineland-3), in a pediatric population referred for autism evaluation. This retrospective study reviewed clinical data extracted over a 3-year period (2018-2021). A latent class analysis was used to explore the presence of latent groups guided by the likelihood ratio test and fit indices. Additional analyses contrasted ASD and non-ASD groups on the BASC-3 and Vineland-3 variables. There were 191 included participants (mean age 65.9 months, 76.4% male), of whom over half (60.7%) had an ASD diagnosis. Using 185 cases, the exploratory latent class analysis showed the emergence of 4 distinct subgroups. Composition of classes varied on ASD diagnosis, neurodevelopmental difficulties, behavioral health concerns, and intellectual disability. When contrasting ASD and non-ASD groups, significant between-group differences were observed across Vineland-3 variables and BASC-3 adaptive skills subscales indicating poorer social and adaptive functioning. Latent class analysis of commonly used behavioral and adaptive measures can help distinguish between subgroups of pediatric patients referred for ASD evaluations and assist in triage of cases based on severity.

Diagnostic validity of p16, E-cadherin, cyclin D1, p53, and HPV E6/E7 mRNA in CIN 3-like squamous cell carcinoma of the cervix.

Cervical intraepithelial neoplasia grade 3 (CIN 3)-like SCC is a recently identified deceptive growth pattern that closely mimics endocervical crypt involvement by CIN 3. As CIN 3-like SCC is indistinguishable from endocervical crypt involvement by CIN 3, it poses a significant challenge for pathologists. We examined 23 cases of CIN 3-like SCC, 6 of which also had concomitant conventional invasive SCC, and 9 cases of endocervical crypt involvement by CIN 3 as a control group. Immunohistochemistry was used to investigate the expression of p16, E-cadherin, cyclin D1, and p53, and the expression of human papillomavirus (HPV) E6/E7 mRNA, the key virus carcinogen of HPV, was detected. The clinicopathological, immunohistochemical, and molecular characteristics of endocervical crypt involvement by CIN 3, CIN 3-like SCC, and the concomitant conventional invasive SCC element were examined. CIN 3-like SCC exhibited a characteristic morphology similar to endocervical crypt involvement by CIN 3, with pushing borders invading into the wall of the cervix, often to a significant depth in most cases. Immunophenotypic features of E-cadherin, p16, cyclin D1, and p53 differed between CIN 3-like SCC and conventional invasive SCC, both in staining intensity and region. E6/E7 mRNA expression was higher in CIN 3-like SCC than in endocervical crypt involvement by CIN 3 (P < 0.05). CIN 3-like SCC is the type of cancer, presenting numerous challenges and potential for confusion as it mimics the phenotypes of endocervical crypt involvement by CIN 3.

Diagnostic Validation and Feasibility of a Non-invasive Haemoglobin Screening Device (EzeCheck) for 'Anaemia Mukt Bharat' in India.

Anaemia remains a major public health issue in India despite several efforts. It is crucial to introduce technology-based innovations for the mass screening and early diagnosis of anaemia. Traditional anaemia screening requires drawing blood and laboratory analysis and can be logistically expensive in resource-constrained settings. A non-invasive haemoglobin test for mass screening in such settings is vital which can quickly and efficiently screen large populations. This study validated the haemoglobin estimation between the invasive haematology analyzer and the non-invasive EzeCheck (EzeRx Health Tech Pvt. Ltd.,Bhubaneswar, Odisha, India) in the community setting. We conducted a cross-sectional study among 416 urban slum members in Bhubaneswar, India. We used inter-rater reliability (kappa statistic) of haemoglobin estimation between the haematology analyzer and EzeCheck devices. The finding showed a moderate agreement between both devices (kappa=0.4221). Between both devices, 91.59% of the results were with +/-1.5 difference; 43.51%, no difference; 33.65%, less than one difference; and 14.42%, +/-1 to +/-1.5 difference of haemoglobin estimation. There was no significant difference in overall anaemia status estimates between the devices. Mass screening in schools and communities with non-invasive haemoglobin tests can help identify anaemic people for early diagnosis and bring patients for timely treatment, which can be used in remote areas to support 'Anaemia Mukt Bharat'.

P454 Systemic free thiols associate with clinical and biochemical disease activity in Inflammatory Bowel Disease: a prospective diagnostic validation study

Abstract Background In the pathophysiology of inflammatory bowel diseases (IBD), oxidative stress plays an important role. Lower levels of plasma free thiols (FT) reflect a higher oxidative stress burden and correlate with IBD disease activity. However, their clinical significance as biomarker for disease activity remains unclear. This study aimed to prospectively validate the utility of plasma FT levels as biomarker for clinical, biochemical, and endoscopic disease activity in patients with IBD. Methods In an ongoing prospective diagnostic trial aiming to include 100 IBD patients, we conducted an interim analysis of plasma FT levels in 52 patients with IBD (24 Crohn's disease [CD], 21 ulcerative colitis [UC], and 7 patients with undetermined IBD). Clinical disease activity was quantified by the Harvey-Bradshaw Index (HBI) for CD and Simple Clinical Colitis Activity Index (SCCAI) for UC. Biochemical disease activity was determined by measuring blood C-reactive protein [CRP] and faecal calprotectin [fCal]). Endoscopic disease activity was quantified with the Mayo endoscopic subscore for UC and the Simple Endoscopic Score (SES-CD) for CD. Plasma FT levels were assessed for correlations with disease activity parameters using linear and logistic regressions models. Discriminative capacity of biomarkers was evaluated through calculating receiver operating characteristics (ROC) statistics. Results Plasma FT levels were significantly negatively correlated in clinical parameters, like HBI (r = -0.53, p &amp;lt; 0.05) (Fig. 1A). Other inflammatory biomarkers, like CRP, were also negatively correlated with plasma FT levels and were reduced in patients with active IBD (r = -0.43, p &amp;lt; 0.05) (Fig. 1B). Plasma FT levels accurately discriminated between CD patients with clinically quiescent (HBI &amp;lt; 5) and active disease (HBI ≥ 5) (AUC = 0.80, p = 0.02, Fig. 1C), better than fCal (AUC = 0.55, p = 0.83). Plasma FT were not significantly different for biochemically quiescent (CRP &amp;lt; 5 mg/l) and active (CRP ≥ 5mg/l) disease (AUC = 0.69, p = 0.20, Fig. 1D). Both Mayo and SES-CD scores, after adjusting for confounders, also exhibited a trend towards negative association with plasma FT levels (Fig. 1E). Figure 1 Conclusion Further completion of the trial will reveal whether systemic FT levels will reflect endoscopically observed disease activity, and this interim analysis shows strong correlations FT levels and parameters of clinically and biochemically active disease. Measuring systemic FTs in IBD may be a promising, minimally invasive strategy to monitor IBD disease activity. Funding None

Definition and validation of the nursing diagnosis label “wish to die”: a research protocol

BackgroundEuthanasia has been incorporated into the health services of seven countries. The legalisation of these practices has important repercussions for the competences of nurses, and it raises questions about their role. When a patient with advanced disease expresses a wish to die, what is expected of nurses? What are the needs of these patients, and what kind of care plan do they require? What level of autonomy might nurses have when caring for these patients? The degree of autonomy that nurses might or should have when it comes to addressing such a wish and caring for these patients has yet to be defined. Recognising the wish to die as a nursing diagnosis would be an important step towards ensuring that these patients receive adequate nursing care.This study-protocol aims to define and validate the nursing diagnosis wish to die in patients with advanced disease, establishing its defining characteristics and related factors; to define nursing-specific interventions for this new diagnosis.MethodsA prospective three-phase study will be carried out. Phase-A) Foundational knowledge: an umbrella review of systematic reviews will be conducted; Phase-B) Definition and validation of the diagnostic nomenclature, defining characteristics and related factors by means of an expert panel, a Delphi study and application of Fehring’s diagnostic content validation model; Phase-C) Definition of nursing-specific interventions for the new diagnosis. At least 200 academic and clinical nurses with expertise in the field of palliative care or primary health care will be recruited as participants across the three phases.DiscussionThe definition of the wish to die as a nursing diagnosis would promote greater recognition and autonomy for nurses in the care of patients who express such a wish, providing an opportunity to alleviate underlying suffering through nursing-specific interventions and drawing attention to the needs of patients with advanced disease. The new diagnosis would be an addition to nursing science and would provide a framework for providing care to people with advanced disease who express such a wish. Nurses would gain professional autonomy about identifying, exploring and responding clinically to such a wish.

Validation of Diagnostic Accuracy and Disease Severity Correlation of Chest Computed Tomography Severity Scores in Patients with COVID-19 Pneumonia.

The aim of our study was to establish and compare the diagnostic accuracy and clinical applicability of published chest CT severity scoring systems used for COVID-19 pneumonia assessment and to propose the most efficient CT scoring system with the highest diagnostic performance and the most accurate prediction of disease severity. This retrospective study included 218 patients with PCR-confirmed SARS-CoV-2 infection and chest CT. Two radiologists blindly evaluated CT scans and calculated nine different CT severity scores (CT SSs). The diagnostic validity of CT SSs was tested by ROC analysis. Interobserver agreement was excellent (intraclass correlation coefficient: 0.982-0.995). The predominance of either consolidations or a combination of consolidations and ground-glass opacities (GGOs) was a predictor of more severe disease (both p < 0.005), while GGO prevalence alone was not. Correlation between all CT SSs was high, ranging from 0.848 to 0.971. CT SS 30 had the highest diagnostic accuracy (AUC = 0.805) in discriminating mild from severe COVID-19 disease compared to all the other proposed scoring systems (AUC range 0.755-0.788). In conclusion, CT SS 30 achieved the highest diagnostic accuracy in predicting the severity of COVID-19 disease while maintaining simplicity, reproducibility, and applicability in complex clinical settings.