Substantial Level Of Agreement Research Articles

Translation, cultural adaptation, and evaluation of the psychometric properties of the Arabic Gastroesophageal Reflux Disease Questionnaire (Ar-GerdQ)

Abstract Background: Gastroesophageal reflux disease (GERD) is a common chronic digestive disease that affects people in different communities at different rates. Because of the absence of a validated Arabic tool to assess GERD symptoms, this study aimed to validate and culturally adapt the GERD questionnaire (GerdQ) tool to Arabic speakers. Methods: Patients referred for pH testing with symptoms suggestive of GERD were recruited. A cross-sectional study was conducted from March 2023 to April 2023 by administering the Arabic GERD questionnaire (Ar-GerdQ) tool on two different occasions and comparing it with the short-form leeds dyspepsia questionnaire and the Reflux Symptom Index to establish reliability and construct validity. Results: A total of 52 participants were included in the study. The results of the internal consistency analysis of the Ar-GerdQ indicate that the test has good reliability, with a Cronbach’s alpha coefficient of 0.86 (95% CI: 0.75–0.91). Significant positive correlations with the short form leeds dyspepsia questionnaire (r = 0.59, P < 0.001, 95% CI: 0.29–0.78) and the reflux symptom index (r = 0.47, P = 0.01, 95% CI: 0.13–0.71) were demonstrated. Moreover, the intraclass correlation coefficient value was 0.60 (P < 0.001, 95% CI: 0.28–0.77), indicating a substantial level of agreement between the measurements. Conclusions: Our findings indicate that the Ar-GerdQ is useful for assessing reflux disease symptoms among Arabic speakers. Effective utilization of Ar-GerdQ will reduce unnecessary endoscopic requests in primary care settings.

#501 Evaluation of the accuracy of serum creatinine-based GFR calculations across the different levels of renal function among Filipinos

Abstract Background and Aims Chronic kidney disease (CKD) is a worldwide health concern which continues to increase in prevalence. Early studies have evaluated kidney function by measuring serum creatinine (sCr) and/or the estimated glomerular filtration rate (eGFR). To date, there are limited studies that correlate nuclear GFR scans and eGFR by equations that include the Cockroft-Gault (CG), Modification of Diet in Renal Disease (MDRD), and Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) 2021 in Asians, specifically in a Filipino population. This study aims to compare the accuracy of GFR scan results and GFR estimated from the formulas across different levels of kidney functions, age groups, gender, and co-morbidities among a Filipino subset. Method A cross-sectional study was done among 2986 patients who underwent Nuclear GFR scan in a single kidney center. Results obtained were compared to estimated GFR results. Weighted Kappa and Bland-Altman Analyses were used to test for agreement between the measured and estimated GFR results. Results Absolute GFR values derived from the three equations demonstrated moderate reliability with results from nuclear scan when intraclass correlation coefficients were calculated with CKD-EPI 2021 being the highest. When further categorized into GFR levels, there was substantial level of agreement between each equation and GFR scan, with all weighted kappa coefficients being at least 0.700 with CG having the highest result (Table 1). Furthermore, when subgroup analysis was done according to age group, gender, and comorbidities, CG was found to be the most accurate per category (Table 2). Conclusion CKD-EPI 2021 was the most accurate in the actual GFR values however we cannot fully eliminate the utility of CG due to its categorical accuracy and in monitoring the deterioration of renal function.

Performance evaluation of loop-mediated isothermal amplification, polymerase chain reaction and real-time polymerase chain reaction methods to detect Neisseria gonorrhoeae among symptomatic patients from India.

Background: Neisseria gonorrhoeae is one of the most important causative organisms in causing sexually transmitted infections. The clinical presentation of gonorrhoea mimics the symptoms of other sexually transmitted infections, and a proper diagnosis of the same is therefore crucial in patient management. The current study intended to compare different in-house molecular methods: that is, conventional PCR, real-time PCR, and LAMP assay for detection of N. gonorrhoeae. Methods: A total of 163 samples were collected from 145 patients who presented with urethral and vaginal discharge. Collected samples were processed for culture on GC agar base, and three different molecular diagnostic tests (conventional PCR, real-time PCR, and LAMP assay) were performed simultaneously on all the samples. Results: Culture of N. gonorrhoeae was positive in 17 out of 21 (80.9%) swab samples. With culture as the gold standard method, conventional and real-time PCR had a sensitivity of 94.1%, whereas the sensitivity of the LAMP assay was found to be 88.2%. All three methods had a specificity of 100%. In addition to swab samples, evaluation of urine samples by different molecular methods yielded a good concordance with a kappa value of 0.85 by conventional PCR and real-time PCR showing a perfect level of agreement, while the LAMP assay was found to have a substantial level of agreement. Conclusion: LAMP assay had a comparable diagnostic accuracy to other molecular methods for the detection of N. gonorrhoeae and can be used as a point-of-care test in resource-limited settings.

Lower extremity movement quality in professional team sport athletes: Inter-rater agreement and relationships with quantitative results from the corresponding pattern

BackgroundAdequate movement control and quality can be prerequisite functions for performance of the lower extremity. The purposes of our work were 1) to explore the agreement of an efficient test battery assessing qualitative movement execution and 2) to determine its consistency with quantitative performance tests from the corresponding movement pattern.MethodsThe participants were professional male association football players competing in the first German Bundesliga. They performed four movement quality tests (Single-limb balance squat, Balance forward hop, Balance side hop, Balance 90° rotation hop) and the corresponding performance tests (Y-balance test, Forward hop for distance, Side hop test, Square hop test). Qualitative tests were judged by two experienced raters; the ratings were compared to determine inter-rater agreement using Kappa statistics. The relationship with the quantitative tests was determined using Spearman’s rank correlations.ResultsThirty participants (19 to 33 years old) were included in this study. We found an at least substantial level of agreement (Cohen’s Kappa, 0.64-0.84) with an excellent percentage of exact (83-93%) agreement between the two raters for the movement quality tests. Our findings revealed that the quantitative test results are only slightly related to the movement quality outcomes (ρ(27) <|0.3| and P > 0.2).ConclusionsConsequently, the qualitative test results provide unique information and complement corresponding quantitative performance tests in professional football athletes. Their observational judgement of foot position, lower limb alignment and upper body control in sagittal, frontal, and transverse planes is agreeable.

Grading system for assessing the confidence in the epileptogenic zone reported in published studies: A Delphi consensus study.

This study was undertaken to develop a standardized grading system based on expert consensus for evaluating the level of confidence in the localization of the epileptogenic zone (EZ) as reported in published studies, to harmonize and facilitate systematic reviews in the field of epilepsy surgery. We conducted a Delphi study involving 22 experts from 18 countries, who were asked to rate their level of confidence in the localization of the EZ for various theoretical clinical scenarios, using different scales. Information provided in these scenarios included one or several of the following data: magnetic resonance imaging (MRI) findings, invasive electroencephalography summary, and postoperative seizure outcome. The first explorative phase showed an overall interrater agreement of .347, pointing to large heterogeneity among experts' assessments, with only 17% of the 42 proposed scenarios associated with a substantial level of agreement. A majority showed preferences for the simpler scale and single-item scenarios. The successive Delphi voting phases resulted in a majority consensus across experts, with more than two thirds of respondents agreeing on the rating of each of the tested single-item scenarios. High or very high levels of confidence were ascribed to patients with either an Engel class I or class IA postoperative seizure outcome, a well-delineated EZ according to all available invasive EEG (iEEG) data, or a well-delineated focal epileptogenic lesion on MRI. MRI signs of hippocampal sclerosis or atrophy were associated with a moderate level of confidence, whereas a low level was ascribed to other MRI findings, a poorly delineated EZ according to iEEG data, or an Engel class II-IV postoperative seizure outcome. The proposed grading system, based on an expert consensus, provides a simple framework to rate the level of confidence in the EZ reported in published studies in a structured and harmonized way, offering an opportunity to facilitate and increase the quality of systematic reviews and guidelines in the field of epilepsy surgery.

Diagnosis of malignancy in oropharyngeal confocal laser endomicroscopy using GPT 4.0 with vision.

Confocal Laser Endomicroscopy (CLE) is an imaging tool, that has demonstrated potential for intraoperative, real-time, non-invasive, microscopical assessment of surgical margins of oropharyngeal squamous cell carcinoma (OPSCC). However, interpreting CLE images remains challenging. This study investigates the application of OpenAI's Generative Pretrained Transformer (GPT) 4.0 with Vision capabilities for automated classification of CLE images in OPSCC. CLE Images of histological confirmed SCC or healthy mucosa from a database of 12 809 CLE images from 5 patients with OPSCC were retrieved and anonymized. Using a training data set of 16 images, a validation set of 139 images, comprising SCC (83 images, 59.7%) and healthy normal mucosa (56 images, 40.3%) was classified using the application programming interface (API) of GPT4.0. The same set of images was also classified by CLE experts (two surgeons and one pathologist), who were blinded to the histology. Diagnostic metrics, the reliability of GPT and inter-rater reliability were assessed. Overall accuracy of the GPT model was 71.2%, the intra-rater agreement was κ = 0.837, indicating an almost perfect agreement across the three runs of GPT-generated results. Human experts achieved an accuracy of 88.5% with a substantial level of agreement (κ = 0.773). Though limited to a specific clinical framework, patient and image set, this study sheds light on some previously unexplored diagnostic capabilities of large language models using few-shot prompting. It suggests the model`s ability to extrapolate information and classify CLE images with minimal example data. Whether future versions of the model can achieve clinically relevant diagnostic accuracy, especially in uncurated data sets, remains to be investigated.

Consensus on the detection and management of patients with depression and pain as an associated somatic symptom

IntroductionGlobally, depression is the most common psychiatric disorder and is frequently associated with somatic symptom disorders, including pain as a physical symptom. There is a current need to improve the detection and management of the individuals in which depression and pain coexist. Hence, the aim of this document is to provide recommendations in the diagnosis and management of patients with major depressive disorder (MDD) who have pain as a physical symptom (PPS), in order to reduce the variability of clinical practice. Material and methodsThe methodology used is based on the internationally recognized RAND/UCLA consensus method. The scientific committee, consisted of a group of eight multidisciplinary experts, defined 12 clinically relevant questions. After the systematic review of the literature, the scientific committee assessed the evidence and developed recommendations. The panel group with 15 participants validated these recommendations using a single Delphi round. To conclude, there was a final consensus meeting held to redefine with minor modifications the final recommendations. ResultsThe scientific committee developed a total of 19 recommendations on the diagnosis and detection, impact of PPS in MDD, treatment of MDD with associated PPS, use of healthcare resources, additional recommendations, and care coordination of these patients. Globally, a substantial level of agreement (≥80%) was reached on all items during the Delphi round. All the 19 achieved consensus, seven of them (37%) were agreed with unanimity during the Delphi round. The recommendations with higher consensus were in relation to diagnosis, impact of PPS in MDD, treatment and use of healthcare resources. ConclusionsCurrently, the evidence base for patients with MDD and PPS is still being developed and this consensus statement aims to bridge that gap by providing practical recommendations.

Ki67 assessment protocol as an integral biomarker for avoiding radiotherapy in the LUMINA breast cancer trial.

The LUMINA trial demonstrated a very low local recurrence rate in women ≥55 years with low-risk luminal A breast cancer (defined as grade I-II, T1N0, hormone receptor positive, HER2 negative and Ki67 index ≤13.25%) treated with breast-conserving surgery and endocrine therapy (but no other systemic therapy), supporting the safe omission of radiation in these women. Here we describe the protocol for Ki67 assessment, the companion diagnostic used to guide omission of adjuvant radiotherapy. Ki67 immunohistochemistry was performed on full-face sections at one of three regional labs. Pathologists trained in the International Ki67 in Breast Cancer Working Group (IKWG) method demarcated tumour areas on scanned slides and scored 100 nuclei from each of at least five randomly selected 1-mm fields. For cases with high Ki67 heterogeneity, further virtual cores were selected and scored in order to confidently assign a case as luminal A (≤13.25%) or B (>13.25%). Interlaboratory variability was assessed through an annual quality assurance programme during the study period. From the quality assurance programme, the mean Ki67 index across all cases/labs was 13%. The observed intraclass correlation coefficient (ICC) and kappa statistics were ≥0.9 and ≥0.7, respectively, indicating a substantial level of agreement. Median scoring time was 4 min per case. The IKWG-recommended scoring method, performed directly from slides, requiring up to four scored fields, is concordant with the LUMINA scoring method (ICC ≥ 0.9). Ki67 is a practical, reproducible, and inexpensive biomarker that can identify low-risk luminal A breast cancers as potential candidates for radiation de-escalation. ClinicalTrials.gov number, NCT01791829.

Active involvement of people with lived experience of suicide in suicide research: a Delphi consensus study

BackgroundThe importance and value of involvement of people with lived experience of suicide has been recognized in suicide research and prevention. Nonetheless, clear guidance on research collaboration and co-production is lacking. This study aimed to address this gap by developing a set of guidelines on active involvement of people with lived experience of suicide in suicide studies., i.e., conducting research with or by people with lived experience, rather than to, about or for them.MethodsThe Delphi method was used to determine statements on best practice for the active involvement of people with lived experience of suicide in suicide research. Statements were compiled through a systematic search of the scientific and grey literature, and reviewing qualitative data from a recent related study conducted by the authors. Two expert panels: people with lived experience of suicide (n = 44) and suicide researchers (n = 29) rated statements over three rounds of an online survey. Statements endorsed by at least 80% of panellists of each panel were included in the guidelines.ResultsPanellists endorsed 96 out of 126 statements in 17 sections covering the full research cycle from deciding on the research question and securing funding, to conducting research and disseminating and implementing outcomes. Overall, there was a substantial level of agreement between the two panels regarding support from research institutions, collaboration and co-production, communication and shared decision making, conducting research, self-care, acknowledgment, and dissemination and implementation. However, panels also disagreed on specific statements regarding representativeness and diversity, managing expectations, time and budgeting, training, and self-disclosure.ConclusionsThis study identified consensus recommendations on active involvement of people with lived experience of suicide in suicide research, including co-production. Support from research institutions and funders, and training on co-production for researchers and people with lived experience, are needed for successful implementation and uptake of the guidelines.

Comparison of a validated decision-support tool to a standard of care triage system for knee osteoarthritis assessment: a proof-of-concept study.

Patients with knee osteoarthritis (OA) in northwestern Ontario are referred by their primary care provider (PCP) to a centralized assessment clinic for evaluation by an advanced practice physiotherapist (APP) to determine if they will require surgical management. However, many patients are found to not require surgical management, resulting in delays for patients who do. A decision-support tool was developed to address this issue and to guide treatment options by determining the need for surgical or nonsurgical approaches. We used a proof-of-concept method to assess the use of the decision-support tool in northwestern Ontario. Data from 100 consecutive patients assessed for knee OA management were collected from the Thunder Bay centralized assessment clinic. Two levels of agreement analyses (calculated using Cohen κ statistic) were performed, between the APP assessment decision (surgical or non-surgical) and the decision-support tool recommendation, and between the surgeon's decision (surgical or non-surgical) and the decision-support tool recommendation. We found a near-perfect agreement (κ = 0.870, n = 65) between the APP decision and the decision-support tool recommendation, when controlled for patient preference. There was a substantial level of agreement (κ = 0.618, n = 72) between the decision-support tool recommendation and the surgeon's decision. The decision-support tool recommendation showed considerable agreement with the decisions of the APP and surgeon indicating that it could be a valuable tool to guide PCPs caring for patients with knee OA. The applicability of a decision-support tool in northwestern Ontario displayed promising results, but further research is needed to examine the feasibility in a primary care setting.

Redefining and categorizing emergency medical service opioid-related incidents in Massachusetts.

To create a novel emergency medical service (EMS) opioid-related incident (ORI) tiering framework to describe more accurately the opioid epidemic in Massachusetts. By classifying the data, we could more accurately detail differing trends among the new categories. Free-text fields of Massachusetts EMS reports, from 2013 through 2020, were analyzed to identify ORIs and then categorized into a five-tier severity cascade based on symptom presentation: 'dead on arrival,' 'acute overdose,' 'intoxication,' 'withdrawal' and 'other ORI.' As a validation of the new classification, an emergency medical technician, paramedic and emergency medical physician reviewed clinical reports and assigned a severity category to 100 randomly selected cases. The algorithm then assessed the same 100 cases to determine if it could accurately identify the severity category for each case. Validation of the algorithm by clinical review indicated a substantial level of agreement between the algorithm and the reviewers. Over half of all ORIs were acute overdose (55%), 21% were intoxication, 20% were other ORI, 3% were withdrawal, and 1% were dead on arrival. Overall ORIs decreased in 2020, but the number of 'dead on arrival' increased 32% from 2019. Administration of naloxone also differed between the categories, with 95% of acute overdose and 29% of intoxication receiving naloxone. This novel categorization of emergency medical service opioid-related incidents in Massachusetts, United States, reveals new trend details and strains on the emergency medical service system. Using these categories also improves dataset linkage within the state and interstate rate comparisons.

Confocal laser microscopy for assessment of surgical margins during radical prostatectomy.

To evaluate the feasibility of confocal laser microscopy (CLM) for intraoperative margin assessment as faster alternative to neurovascular structure-adjacent frozen-section examination (NeuroSAFE) during robot-assisted radical prostatectomy (RARP). Surgical margins were assessed during 50 RARP procedures in patients scheduled for NeuroSAFE. Posterolateral sections were cut and imaged with CLM and further processed to conform with the NeuroSAFE protocol. Secondary resection (SR) was performed in case a positive surgical margin (PSM) was observed with NeuroSAFE. Afterwards, the CLM images were non-blinded assessed for the presence of PSMs. The accuracy of both NeuroSAFE and CLM was compared with conventional histopathology. Agreement for detection of PSMs between NeuroSAFE and CLM was evaluated with Cohen's kappa coefficient. Procedure times were compared with a Wilcoxon signed-ranks test. In total, 96 posterolateral sections of RP specimens were evaluated for the presence of PSMs. CLM identified 15 (16%) PSMs and NeuroSAFE identified 14 (15%) PSMs. CLM had a calculated sensitivity, specificity, positive predictive value and negative predictive value of 86%, 96%, 80% and 98% respectively for the detection of PSMs compared to definite pathology. After SR, residual tumour was found in six of 13 cases (46%), which were all identified by both techniques. There was a substantial level of agreement between CLM and NeuroSAFE (κ = 0.80). The median procedure time for CLM was significantly shorter compared to NeuroSAFE (8 vs 50 min, P< 0.001). The main limitation of this study was the non-blinded assessment of the CLM images. Compared to NeuroSAFE, CLM is a promising technique for intraoperative margin assessment and is able to reduce the time of intraoperative margin assessment.

Is 18F-FDG PET Needed to Assess 177Lu-PSMA Therapy Eligibility? A VISION-like, Single-Center Analysis.

18F-FDG and prostate-specific membrane antigen (PSMA) PET have been used to assess eligibility for PSMA-targeted therapy by some centers. However, it remains unclear whether both examinations are needed as a part of workup in the clinical practice or whether PSMA PET alone, as was done in the positive phase 3 VISION trial, is sufficient to identify suitable candidates. The aim was to reanalyze all patients who underwent both 18F-FDG and PSMA PET for PSMA-targeted therapy eligibility assessment using the VISION trial criteria. Methods: Eighty-nine men with metastatic castration-resistant prostate cancer referred to 177Lu-PSMA therapy from June 2019 to October 2021 who underwent both 18F-FDG and PSMA PET (using either 68Ga-PSMA-11 or 18F-PSMA-1007) examinations within 2 wk were included in this analysis. Eligibility status was determined in accordance with either knowledge of both 18F-FDG and PSMA PET (clinical routine) or VISION criteria with PSMA PET-only (study reassessment, done twice with liver only for PSMA-11 and liver/spleen as reference for PSMA-1007). A metastasis seen on 18F-FDG PET or CT but not on PSMA PET was denoted as a mismatch finding and led to exclusion from 177Lu-PSMA therapy. On the basis of clinical assessment, 52 patients received 177Lu-PSMA therapy, and 37 did not; all patients were reassessed. Results: Patients treated with 177Lu-PSMA therapy had significantly longer overall survival than those not treated (12.4 vs. 6.8 mo, P < 0.01). PSMA-only analysis (spleen/liver reference) and 18F-FDG/PSMA mismatch reads had substantial agreement (Cohen κ = 0.73). Eighteen percent (n = 16/89) of patients had a mismatch finding based on 18F-FDG/PSMA PET. With the liver/spleen reference, a minor fraction of patients who had no mismatch finding (and were therefore treated) would have been withheld from therapy by PSMA-only analysis (3%). Three percent (n = 3) of all patients had an 18F-FDG/PSMA mismatch finding not detected by PSMA PET-only (VISION-like) analysis. For patients not receiving PSMA therapy, the overall survival was not statistically significantly different comparing 18F-FDG/PSMA mismatch versus nonmismatch (P = 0.61) patients. Conclusion: 18F-FDG and PSMA PET provide complementary information, yet less than 5% of patients had mismatch findings not detected using PSMA PET-only. Based on our data, 18F-FDG/PSMA mismatch examination and PSMA-only analysis have a substantial level of agreement.

Establishment of molecular diagnostics targeting the 23S ribosomal RNA gene for the detection of Mycoplasma suis infection in Thai domestic pigs

Mycoplasma (M.) suis is a pathogenic hemotropic Mycoplasma sp. that causes acute hemolytic anemia or chronic infection in pigs. M. suis infection can be diagnosed using several methods, including molecular diagnosis such as conventional PCR (cPCR) and quantitative PCR (qPCR). In these cases, the common target is the 16S rRNA gene; however, this genetic marker cannot distinguish hemoplasma at the species level owing to high sequence identity. Therefore, the 23S rRNA gene has emerged as another target gene. Other than PCR, the loop-mediated isothermal amplification (LAMP) method can be applied for M. suis. The objective of the present study was to establish cPCR, TaqMan qPCR, and LAMP assays in which the 23S rRNA gene is used to detect M. suis infection in Thai domestic pigs. The analytical sensitivity of cPCR was determined as 7.46 × 104 copies/μl of plasmid DNA, whereas those of qPCR and LAMP were 7.46 × 102 copies/μl. There was no cross reaction with other pathogens in any of the assays. To evaluate the diagnostic performance of the assays, they were tested using 173 samples of genomic DNA. The detection percentage of M. suis infection was 24.86% (43/173; 95% CI: 18.61%–31.89%), 28.32% (49/173; 95% CI: 21.75%–35.66%), and 29.48% (51/173; 95% CI: 22.80%–36.88%) using cPCR, qPCR, and LAMP, respectively. Using qPCR as a reference assay, cPCR showed 81.63% sensitivity, 97.58% specificity, and an almost perfect level of agreement (kappa = 0.823). In comparison, LAMP showed 77.55% sensitivity, 89.52% specificity, and a substantial level of agreement (kappa = 0.662). All assays tested here could be applied in veterinary diagnostic laboratories for monitoring porcine health in the herds. Furthermore, the LAMP assay could be used as a screening test in farm practice without the need for any special equipment.

The development and validation of a medicines optimisation tool to protect the physical health of people with severe mental illness (OPTIMISE)

BackgroundThe life expectancy of people with severe mental illness (SMI) is shorter than those without SMI, with multimorbidity and poorer physical health contributing to health inequality. Screening tools could potentially assist the optimisation of medicines to protect the physical health of people with SMI. The aim of our research was to design and validate a medicines optimisation tool (OPTIMISE) to help clinicians to optimise physical health in people with SMI.MethodsA review of existing published guidelines, PubMed and Medline was carried out. Literature was examined for medicines optimisation recommendations and also for reference to the management of physical illness in people with mental illness. Potential indicators were grouped according to physiological system. A multidisciplinary team with expertise in mental health and the development of screening tools agreed that 83 indicators should be included in the first draft of OPTIMISE. The Delphi consensus technique was used to develop and validate the contents. A 17-member multidisciplinary panel of experts from the UK and Ireland completed 2 rounds of Delphi consensus, rating their level of agreement to 83 prescribing indicators using a 5-point Likert scale. Indicators were accepted for inclusion in the OPTIMISE tool after achieving a median score of 1 or 2, where 1 indicated strongly agree and 2 indicated agree, and 75th centile value of ≤ 2. Interrater reliability was assessed among 4 clinicians across 20 datasets and the chance corrected level of agreement (kappa) was calculated. The kappa statistic was interpreted as poor if 0.2 or less, fair if 0.21–0.4, moderate if 0.41–0.6, substantial if 0.61–0.8, and good if 0.81–1.0.ResultsConsensus was achieved after 2 rounds of Delphi for 62 prescribing indicators where 53 indicators were accepted after round 1 and a further 9 indicators were accepted after round 2. Interrater reliability of OPTIMISE between physicians and pharmacists indicated a substantial level of agreement with a kappa statistic of 0.75.ConclusionsOPTIMISE is a 62 indicator medicines optimisation tool designed to assist decision making in those treating adults with SMI. It was developed using a Delphi consensus methodology and interrater reliability is substantial. OPTIMISE has the potential to improve medicines optimisation by ensuring preventative medicines are considered when clinically indicated. Further research involving the implementation of OPTIMISE is required to demonstrate its true benefit.Trial registrationThis article does not report the results of a health care intervention on human participants.

Validating Performance Standards via Latent Class Analysis

AbstractValidity of performance standards is a key element for the defensibility of standard setting results, and validating performance standards requires collecting multiple pieces of evidence at every step during the standard setting process. This study employs a statistical procedure, latent class analysis, to set performance standards and compares latent class analysis results with previously established performance standards via the modified‐Angoff method for cross‐validation. The context of the study is an operational large‐scale science assessment administered in one of the southern states in the United States. Results show that the number of classes that emerged in the latent class analysis concurs with the number of existing performance levels. In addition, there is a substantial level of agreement between latent class analysis results and modified‐Angoff method in terms of classifying students into the same performance levels. Overall, the findings establish evidence for the validity of the performance standards identified via the modified‐Angoff method. Practical implications of the study findings are discussed.

Artificial intelligence in positioning between mandibular third molar and inferior alveolar nerve on panoramic radiography

Determining the exact positional relationship between mandibular third molar (M3) and inferior alveolar nerve (IAN) is important for surgical extractions. Panoramic radiography is the most common dental imaging test. The purposes of this study were to develop an artificial intelligence (AI) model to determine two positional relationships (true contact and bucco-lingual position) between M3 and IAN when they were overlapped in panoramic radiographs and compare its performance with that of oral and maxillofacial surgery (OMFS) specialists. A total of 571 panoramic images of M3 from 394 patients was used for this study. Among the images, 202 were classified as true contact, 246 as intimate, 61 as IAN buccal position, and 62 as IAN lingual position. A deep convolutional neural network model with ResNet-50 architecture was trained for each task. We randomly split the dataset into 75% for training and validation and 25% for testing. Model performance was superior in bucco-lingual position determination (accuracy 0.76, precision 0.83, recall 0.67, and F1 score 0.73) to true contact position determination (accuracy 0.63, precision 0.62, recall 0.63, and F1 score 0.61). AI exhibited much higher accuracy in both position determinations compared to OMFS specialists. In determining true contact position, OMFS specialists demonstrated an accuracy of 52.68% to 69.64%, while the AI showed an accuracy of 72.32%. In determining bucco-lingual position, OMFS specialists showed an accuracy of 32.26% to 48.39%, and the AI showed an accuracy of 80.65%. Moreover, Cohen’s kappa exhibited a substantial level of agreement for the AI (0.61) and poor agreements for OMFS specialists in bucco-lingual position determination. Determining the position relationship between M3 and IAN is possible using AI, especially in bucco-lingual positioning. The model could be used to support clinicians in the decision-making process for M3 treatment.

Utility and reliability of the Clinical Frailty Scale in patients scheduled for major vascular surgery: a prospective, observational, multicentre observer-blinded study

BackgroundFrailty is a distinctive health state associated with a loss of physiological reserve that results in higher rates of perioperative complications and impaired return to pre-morbid functional status. It is prevalent in the vascular population; however routine assessment is not common despite national guidance to the contrary. We aimed to evaluate the reliability of the Clinical Frailty Scale in assessing frailty in the surgical vascular population.MethodsIn this prospective, observational, observer-blinded study, we compared assessment of frailty in patients scheduled for major vascular surgery attending the pre-operative assessment clinic using the Clinical Frailty Scale against the Edmonton Frailty Scale.The study investigator completed the Edmonton Frailty Scale assessment; this was compared to the Clinical Frailty Scale assessments performed by the pre-assessment consultant and pre-assessment nurse, who were blinded to the Edmonton Frailty Scale score. The inter-rater reliability of the Clinical Frailty Scale between the pre-assessment consultant and pre-assessment nurse was determined by comparing their frailty scores for each patient.ResultsNinety-seven patients were included in the analysis (median age 72 years, 84% male and 16% female). There was a moderate level of agreement between the Edmonton and Clinical Frailty Scale score for both consultants (87.6% agreement) and pre-assessment nurses (87.6% agreement). There was a substantial level of agreement between consultants and pre-assessment nurses for the Clinical Frailty Scale (89.7% agreement)ConclusionsThe Clinical Frailty Scale is a useful tool to assess frailty in the vascular surgical population. It is more practical than the Edmonton Frailty Scale: quick to complete, requires minimal training and can be used when physical disability is present.Trial registrationThe study was approved by the Wales Health and Care Research Ethics Service (REC reference 17/WA/0160, IRAS 201173). Trial registration: NCT03403673. Registered 19 January 2018, https://clinicaltrials.gov/ct2/show/NCT03403673

Evaluating performance of multiplex real time PCR for the diagnosis of malaria at elimination targeted low transmission settings of Ethiopia

BackgroundMalaria incidence has declined in Ethiopia in the past 10 years. Current malaria diagnostic tests, including light microscopy and rapid antigen-detecting diagnostic tests (RDTs) cannot reliably detect low-density infections. Studies have shown that nucleic acid amplification tests are highly sensitive and specific in detecting malaria infection. This study took place with the aim of evaluating the performance of multiplex real time PCR for the diagnosis of malaria using patient samples collected from health facilities located at malaria elimination targeted low transmission settings in Ethiopia.MethodsA health facility-based, cross-sectional survey was conducted in selected malaria sentinel sites. Malaria-suspected febrile outpatients referred to laboratory for malaria testing between December 2019 and March 2020 was enrolled into this study. Sociodemographic information and capillary blood samples were collected from the study participants and tested at spot with RDTs. Additionally, five circles of dry blood spot (DBS) samples on Whatman filter paper and thick and thin smear were prepared for molecular testing and microscopic examination, respectively. Multiplex real time PCR assay was performed at Ethiopian Public Health Institute (EPHI) malaria laboratory. The performance of multiplex real time PCR assay, microscopy and RDT for the diagnosis of malaria was compared and evaluated against each other.ResultsOut of 271 blood samples, multiplex real time PCR identified 69 malaria cases as Plasmodium falciparum infection, 16 as Plasmodium vivax and 3 as mixed infections. Of the total samples, light microscopy detected 33 as P. falciparum, 18 as P. vivax, and RDT detected 43 as P. falciparum, 17 as P. vivax, and one mixed infection. Using light microscopy as reference test, the sensitivity and specificity of multiplex real time PCR were 100% (95% CI (93–100)) and 83.2% (95% CI (77.6–87.9)), respectively. Using multiplex real time PCR as a reference, light microscopy and RDT had sensitivity of 58% (95% CI 46.9–68.4) and 67% (95% CI 56.2–76.7); and 100% (95% CI 98–100) and 98.9% (95% CI 96–99.9), respectively. Substantial level of agreement was reported between microscopy and multiplex real time PCR results with kappa value of 0.65.ConclusionsMultiplex real-time PCR had an advanced performance in parasite detection and species identification on febrile patients’ samples than did microscopy and RDT in low malaria transmission settings. It is highly sensitive malaria diagnostic method that can be used in malaria elimination programme, particularly for community based epidemiological samples. Although microscopy and RDT had reduced performance when compared to multiplex real time PCR, still had an acceptable performance in diagnosis of malaria cases on patient samples at clinical facilities.

Domiciliary medication review (ReMeDo): development, reliability and acceptability of a tool for community pharmacists.

Polymedication and medication hoarding in patients' homes may increase the risk of drug-related problems (DRPs). Community pharmacists can prevent DRPs through medication reconciliation and review. This study aims to (1) develop a tool for community pharmacists to perform domiciliary medication review (ReMeDo) and (2) assess the interrater and test-retest reliability and acceptability of the tool. The ReMeDo tool was first developed 6 years before this study to perform medication review during pharmacist home visits. A literature review was performed to update the content of the existing tool. Ten pharmacy students participated in the assessment of the interrater and test-retest reliability using three vignettes based on former ReMeDo patients. Test-retest reliability coefficients were calculated for the entire tool and each segment. Global and individual interrater reliability coefficients were also computed. Acceptability was assessed through a satisfaction survey. The ReMeDo tool was structured to guide the collection of information before, during and after the pharmacist home visit. The global kappa coefficients for interrater and test-retest reliability were 0.70 (95% confidence interval (CI), 0.67 to 0.73) and 0.71 (95% CI, 0.68 to 0.74), respectively. The test-retest reliability coefficients for each segment and the interrater reliability coefficients for participants were higher than 0.60 (except for one participant), demonstrating a moderate to substantial level of agreement. The tool was deemed acceptable by participants. The ReMeDo tool proved to be reliable and acceptable for use by community pharmacists to perform medication review in patients' homes.