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1.
Sci Rep ; 14(1): 15680, 2024 Jul 08.
Article in English | MEDLINE | ID: mdl-38977729

ABSTRACT

Extra-pulmonary TB (EPTB) is difficult to diagnose due to paucibacillary nature of disease. Current study evaluated accuracy of Truenat MTB and MTB-Rif Dx (TN), for detection of Mycobacterium tuberculosis and resistance to rifampicin. Samples were collected from 2103 treatment naive adults with presumptive EPTB, and tested by smear microscopy, liquid culture (LC) (MGIT-960) and GeneXpert MTB/RIF (GX) (Microbiological Reference Standards, MRS). TN results were compared to MRS and Composite Reference Standards (CRS, Microbiology, histopathology, radiology, clinical features prompting decision to treat, response to treatment). CRS grouped patients into 551 confirmed, 1096 unconfirmed, and 409 as unlikely TB. TN sensitivity and specificity was 73.7% and 90.4% against GX. Against LC, Overall sensitivity of GX was 67.6%, while that of TN was 62.3%. Highest sensitivity by TN was observed in pus samples (89%) and highest specificity (92%) in CSF samples, similar to GX. TN sensitivity was better in fluid and biopsy samples and slightly inferior for lymph node aspirates compared to GX. TN sensitivity for RIF resistance detection was slightly superior to GX. TN and GX results were further compared to Clinical Reference Standards. TN detected 170 TB patients initiated on treatment missed by GX, while GX detected 113 such patients missed by TN. Of 124 samples with RIF resistance discordance between GX and TN, GX reported 103/124 as sensitive, 3/124 as indeterminate and 18 as resistant (13/18 samples had low/very low DNA load) while TN reported RIF resistance indeterminate in 103/111 low/very low DNA load samples. Due to paucibacillary nature of EPTB samples, culture yield was poor and phenotypic drug susceptibility testing failed to resolve the discordance. The study establishes TN at par with GX and can be utilized for quick and accurate diagnosis of EPTB.


Subject(s)
Mycobacterium tuberculosis , Rifampin , Sensitivity and Specificity , Humans , Mycobacterium tuberculosis/genetics , Mycobacterium tuberculosis/isolation & purification , Mycobacterium tuberculosis/drug effects , Rifampin/pharmacology , Rifampin/therapeutic use , Adult , Female , Tuberculosis/diagnosis , Tuberculosis/microbiology , Tuberculosis/drug therapy , Male , Middle Aged , Microbial Sensitivity Tests , Drug Resistance, Bacterial/genetics , Aged , Young Adult , Tuberculosis, Extrapulmonary
2.
Endocrinol Metab (Seoul) ; 39(3): 489-499, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38721635

ABSTRACT

BACKGRUOUND: The Korean Endocrine Hormone Reference Standard Data Center (KEHRS DC) has created reference standards (RSs) for endocrine hormones since 2020. This study is the first of its kind, wherein the KEHRS DC established RSs for serum Cpeptide levels in a healthy Korean population. METHODS: Healthy Korean adults were recruited from May 2021 to September 2023. After excluding participants according to our criteria, serum samples were collected; each participant could then choose between fasting glucose only or fasting glucose plus an oral glucose tolerance test (OGTT). If their sample showed high glucose (≥100 mg/dL) or hemoglobin A1c (HbA1c) (≥5.70%), their C-peptide levels were excluded from analyzing the RSs. RESULTS: A total of 1,532 participants were recruited; however, only the data of 1,050 participants were analyzed after excluding those whose samples showed hyperglycemia or high HbA1c. Post-30-minute OGTT data from 342 subjects and post-120-minute OGTT data from 351 subjects were used. The means±2 standard deviations and expanded uncertainties of fasting, post-30-minute and 120-minute OGTT C-peptide levels were 1.26±0.82 and 0.34-3.18, 4.74±3.57 and 1.14-8.33, and 4.85±3.58 and 1.25-8.34 ng/mL, respectively. Serum C-peptide levels correlated with obesity, serum glucose levels, and HbA1c levels. CONCLUSION: The RSs for serum C-peptide levels established in this study are expected to be useful in both clinical and related fields.


Subject(s)
Blood Glucose , C-Peptide , Humans , C-Peptide/blood , Republic of Korea , Female , Male , Adult , Middle Aged , Blood Glucose/analysis , Glucose Tolerance Test/standards , Reference Standards , Reference Values , Glycated Hemoglobin/analysis , Young Adult , Aged , Biomarkers/blood
3.
J Breath Res ; 18(3)2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38740047

ABSTRACT

Standardisation is the road to improvement! If we all measure exhaled nitric oxide (NO) the same way, we will be successful in having data to make reference questions. Many research groups have published their reference equation, but most differ considerably. About 25 years ago, using the flow of 50 ml s-1was recommended and not using a nose clip. When collecting data worldwide, we still see publications that do not indicate what flow was used and that nose clip was utilised. Three things are needed: the analysing method, a flow recording and a filled-in nitric oxide questionnaire. The analysing method is because the techniques have different sensitivity, response times and calibration. The flow of 50 ml s-1is on the steep part of the NO output curve; therefore, we need to record the flow to analyse repeated measurements or compare results. The NO questionnaire controls individual factors that may influence the NO measurements, i.e. food intake, smoking and upper airway infection. An important tool in following old and new disease treatments, at home or in health care, is exhaled biomarkers. If we follow the standardisation we have agreed upon, we will be able to have data to say what a high or a low exhaled NO value is.


Subject(s)
Breath Tests , Exhalation , Nitric Oxide , Humans , Biomarkers/analysis , Breath Tests/methods , Nitric Oxide/analysis , Nitric Oxide/metabolism , Reference Values , Surveys and Questionnaires
4.
Belitung Nurs J ; 10(2): 176-184, 2024.
Article in English | MEDLINE | ID: mdl-38690299

ABSTRACT

Background: Basic non-military flight nurse training is essential for enhancing nurses' competency in conducting aeromedical evacuations. Trained nurses possessing flight nurse proficiency are indispensable for ensuring stable patient conditions amidst the unique physical, physiological, and psychological challenges encountered during flights. Objective: This study aimed to describe the experiences and perceptions of nurses and air ambulance service providers regarding aeromedical evacuations. Methods: This study employed a qualitative descriptive design. Data were gathered from February to July 2023 through semi-structured online interviews with seven nurses and air ambulance service providers engaged in aeromedical evacuation. Content analysis was utilized to interpret the interview data. Results: Seven themes were generated: 1) Experiences in aeromedical evacuation experiences, 2) Challenges faced by nurses and air ambulance service providers during aeromedical evacuations, 3) Essential knowledge for nurses involved in aeromedical evacuations, 4) Efforts to improve nurses' knowledge and skills, 5) Leveling of flight nurse training, 6) Flight nurse training methods, and 7) Flight nurse training evaluation strategies. Conclusion: Nurses and air ambulance service providers acknowledge the significant influence of the flight environment on changes in patient conditions during aeromedical evacuations. To effectively manage alterations in patient conditions during flights, healthcare workers equipped with aviation health competency are imperative. One approach to enhancing the competency of healthcare workers is through flight nurse training. The findings from this study serve as a valuable resource for policymakers and health-related institutions endeavoring to formulate aeromedical evacuation strategies.

5.
Arch Argent Pediatr ; : e202310296, 2024 May 30.
Article in English, Spanish | MEDLINE | ID: mdl-38787857

ABSTRACT

Introduction. Head circumference (HC) is an indicator of brain growth; growth charts are necessary to determine normal or pathological variations. Objectives. To present the first Argentine HC reference charts between birth and 19 years of age and to compare them with the Nellhaus charts, which have been used in our country to date. Population and methods. These references were developed based on combined data from the National Survey on Nutrition and Health of 2018 and cross-sectional studies conducted between 2004 and 2007 in the provinces of Buenos Aires and La Pampa, which included 8326 healthy children and adolescents. Growth curves were adjusted using the LMS method. To assess the differences between these reference charts and the Nellhaus charts, at different ages, the 2nd, 50th, and 98th percentiles were plotted. Results. HC showed a variable increase in size with age, which was greater in the first years of life, and a slight increase at puberty. The values for the 98th percentile of the Argentine reference charts werehigher than those of the Nellhaus charts at all ages. The values for the 2nd percentile of the national reference were lower than those of the Nellhaus charts during the first 2 years of life, similar between 3 and 7 years of age, and higher after this age. Conclusions. The Argentine curves adequately describe the growth pattern of HC. The differences found with the Nellhaus charts may be attributed to secular changes.


Introducción. El perímetro cefálico (PC) es un indicador del crecimiento cerebral y es necesario contar con referencias de crecimiento que permitan determinar variaciones normales o patológicas. Objetivos. Presentar las primeras referencias argentinas de perímetro cefálico entre el nacimiento y los 19 años, y compararlas con las referencias de Nellhaus, utilizadas en nuestro país hasta la actualidad. Población y métodos. Para la construcción de estas referencias, se combinaron datos de la Encuesta Nacional de Nutrición y Salud 2018 y estudios transversales realizados entre 2004 y 2007 en las provincias de Buenos Aires y La Pampa, que incluyeron 8326 niños, niñas y adolescentes sanos. Las curvas de crecimiento fueron ajustadas con el método LMS. Para evaluar la magnitud de las diferencias entre estas referencias y las de Nellhaus, a diferentes edades, se graficaron los centilos 2, 50 y 98. Resultados. El PC mostró un incremento de tamaño variable con la edad, de mayor magnitud en los primeros años de vida, y un ligero incremento en la pubertad. Los valores del centilo 98 de las referencias argentinas fueron mayores que los de Nellhaus en todas las edades. Los valores del centilo 2 de la referencia nacional fueron menores que los de Nellhaus durante los primeros 2 años de vida, similares entre los 3 y 7 años, y mayores a partir de esta edad. Conclusiones. Las curvas argentinas describen adecuadamente el patrón de crecimiento del PC. Las diferencias halladas con la referencia de Nellhaus pueden atribuirse a cambios seculares.

6.
Skeletal Radiol ; 2024 May 22.
Article in English | MEDLINE | ID: mdl-38775948

ABSTRACT

OBJECTIVE: To evaluate the prevalence of shoulder adhesive capsulitis (AC) signs on MR studies of patients with various common shoulder conditions. METHODS: MR images of 316 patients were retrospectively evaluated. Patients were divided into three groups: controls (66 patients), clinical AC (63 patients), and study group (187 patients). The final diagnosis of AC was reached clinically. The study group was composed of patients with focal and massive rotator cuff tears, active hydroxyapatite deposition disease, fractures around the shoulder, and post-surgery. The following AC signs were evaluated: inferior glenohumeral ligament (IGHL) thickening; coracohumeral ligament (CHL) thickening; and hyperintensity of the inferior glenohumeral ligament, which was graded in four classes. RESULTS: The IGHL signal intensity was statistically higher in patients with fractures than in controls (P = 0.008). There was no statistically significant difference in IGHL signal between the AC group and patients with massive rotator cuff tears and active hydroxyapatite deposition disease (P > 0.1). IGHL thickness in patients with fractures, massive rotator ruptures, and active hydroxyapatite deposition disease was significantly higher compared to controls (P < 0.02) and significantly lower compared to the AC group (P < 0.0001). Based on these findings, a grading system for fibro-inflammatory capsular changes is proposed. CONCLUSION: MR AC signs are frequent in patients with shoulder conditions other than AC; however, in these patients, capsular changes are less prominent than in patients with clinical AC.

7.
J Healthc Qual Res ; 39(4): 214-223, 2024.
Article in Spanish | MEDLINE | ID: mdl-38594160

ABSTRACT

BACKGROUND AND OBJECTIVE: In Spain, Quality Units play a key and unique role in advising healthcare centers on the methodology of healthcare quality. The objectives of the study were to develop computer algorithms to obtain a synthetic indicator of standard compliance for Quality Units and to pilot its functioning in these units. MATERIALS AND METHODS: The Excel program was used to establish evaluation algorithms, and quantitatively interrelate and weight various categories of standards, as a computer evaluation tool, to build a continuous improvement cycle system, and offer a global synthetic indicator of compliance. The tool was tested in a prospective multicenter pilot study, in which coordinators of Quality Units from different health centers and care settings participated, to evaluate the usefulness of the tool and compliance with the standards, in addition to analyzing the content validity of each standard. RESULTS: The formulas for the structured computer algorithms were developed, consecutively, in a «PLAN-DO-CHECK-ACT¼ improvement cycle for the 9 categories of standards, resulting in a single synthetic indicator of compliance. Twenty-one Quality Units participated in the piloting. The overall average compliance rate for the synthetic indicator was 55.63% with differences between centers (P=.002) and between categories (P<.0001), but not by autonomous communities (P=.86) or by areas (P=.97). Content validity was ensured through the variable of «understanding¼ of the standards (P<.001), and through their «justification¼ with documentary evidence (P<.001). CONCLUSIONS: The computer tool with the synthetic indicator have allowed for the evaluation of standard compliance in Quality Units of healthcare centers.


Subject(s)
Guideline Adherence , Quality Indicators, Health Care , Pilot Projects , Prospective Studies , Spain , Humans , Algorithms , Quality Improvement , Quality of Health Care/standards
8.
Gland Surg ; 13(3): 340-350, 2024 Mar 27.
Article in English | MEDLINE | ID: mdl-38601290

ABSTRACT

Background: The changing medical education environment emphasizes the need for time efficiency, increasing the demand for competency-based medical education to improve trainees' learning strategies. This study was performed to determine the competencies required for successful performance of robotic thyroidectomy (RT) and to determine the consensus of experts for performance of RT. Methods: Data were collected through 12 semi-structured interviews with RT experts and 11 field observations. Cognitive task analysis was performed to determine the competencies required for experts to perform RT. A modified Delphi methodology was used to determine how 20 experts rated the importance of each item of RT performance on a Likert 7-point scale. The criteria for the Delphi consensus were set at a Cronbach's α≥0.80 with two survey rounds. Results: After 11 field observations and 12 semi-structured interviews, 89 items were identified within six modules. These items were grouped into sub-modules according to their theme. The modified Delphi survey, involving 21 experts, reached the consensus standard during the second round (Cronbach's α=0.954), enabling the identification of the 64 most important items within six modules related to RT performance: midline incision to isthmectomy (MID module; n=8), lateral dissection (LAT module; n=7), preservation of inferior parathyroid glands (INF module; n=16), preservation of recurrent laryngeal nerve and dissection of the ligament of Berry (BER module; n=21), dissection of the thyroid upper pole (SUP module; n=10), and specimen removal and closure (END module; n=2). Conclusions: This mixed-method study combining qualitative and quantitative methodology identified modules of core competencies required to perform RT. These modules can be used as a standard and objective guide to train surgeons to perform RT and evaluate outcomes.

9.
Clin Neuroradiol ; 2024 Apr 19.
Article in English | MEDLINE | ID: mdl-38639770

ABSTRACT

PURPOSE: Pre-surgical information about tumor consistency could facilitate neurosurgical planning. This study used multi-dynamic-multi-echo (MDME)-based relaxometry for the quantitative determination of pituitary tumor consistency, with the aim of predicting lesion resectability. METHODS: Seventy-two patients with suspected pituitary adenomas, who underwent preoperative 3 T MRI between January 2020 and January 2022, were included in this prospective study. Lesion-specific T1-/T2-relaxation times (T1R/T2R) and proton density (PD) metrics were determined. During surgery, data about tumor resectability were collected. A Receiver Operating Characteristic (ROC) curve analysis was performed to investigate the diagnostic performance (sensitivity/specificity) for discriminating between easy- and hard-to-remove by aspiration (eRAsp and hRAsp) lesions. A Mann-Whitney-U-test was done for group comparison. RESULTS: A total of 65 participants (mean age, 54 years ± 15, 33 women) were enrolled in the quantitative analysis. Twenty-four lesions were classified as hRAsp, while 41 lesions were assessed as eRAsp. There were significant differences in T1R (hRAsp: 1221.0 ms ± 211.9; eRAsp: 1500.2 ms ±â€¯496.4; p = 0.003) and T2R (hRAsp: 88.8 ms ± 14.5; eRAsp: 137.2 ms ± 166.6; p = 0.03) between both groups. The ROC analysis revealed an area under the curve of 0.72 (95% CI: 0.60-0.85) at p = 0.003 for T1R (cutoff value: 1248 ms; sensitivity/specificity: 78%/58%) and 0.66 (95% CI: 0.53-0.79) at p = 0.03 for T2R (cutoff value: 110 ms; sensitivity/specificity: 39%/96%). CONCLUSION: MDME-based relaxometry enables a non-invasive, pre-surgical characterization of lesion consistency and, therefore, provides a modality with which to predict tumor resectability.

10.
Jpn Dent Sci Rev ; 60: 128-136, 2024 Dec.
Article in English | MEDLINE | ID: mdl-38450159

ABSTRACT

The accuracy of artificial intelligence-aided (AI) caries diagnosis can vary considerably depending on numerous factors. This review aimed to assess the diagnostic accuracy of AI models for caries detection and classification on bitewing radiographs. Publications after 2010 were screened in five databases. A customized risk of bias (RoB) assessment tool was developed and applied to the 14 articles that met the inclusion criteria out of 935 references. Dataset sizes ranged from 112 to 3686 radiographs. While 86 % of the studies reported a model with an accuracy of ≥80 %, most exhibited unclear or high risk of bias. Three studies compared the model's diagnostic performance to dentists, in which the models consistently showed higher average sensitivity. Five studies were included in a bivariate diagnostic random-effects meta-analysis for overall caries detection. The diagnostic odds ratio was 55.8 (95 % CI= 28.8 - 108.3), and the summary sensitivity and specificity were 0.87 (0.76 - 0.94) and 0.89 (0.75 - 0.960), respectively. Independent meta-analyses for dentin and enamel caries detection were conducted and showed sensitivities of 0.84 (0.80 - 0.87) and 0.71 (0.66 - 0.75), respectively. Despite the promising diagnostic performance of AI models, the lack of high-quality, adequately reported, and externally validated studies highlight current challenges and future research needs.

11.
Health Technol Assess ; 28(16): 1-93, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38551135

ABSTRACT

Background: Guidelines for sepsis recommend treating those at highest risk within 1 hour. The emergency care system can only achieve this if sepsis is recognised and prioritised. Ambulance services can use prehospital early warning scores alongside paramedic diagnostic impression to prioritise patients for treatment or early assessment in the emergency department. Objectives: To determine the accuracy, impact and cost-effectiveness of using early warning scores alongside paramedic diagnostic impression to identify sepsis requiring urgent treatment. Design: Retrospective diagnostic cohort study and decision-analytic modelling of operational consequences and cost-effectiveness. Setting: Two ambulance services and four acute hospitals in England. Participants: Adults transported to hospital by emergency ambulance, excluding episodes with injury, mental health problems, cardiac arrest, direct transfer to specialist services, or no vital signs recorded. Interventions: Twenty-one early warning scores used alongside paramedic diagnostic impression, categorised as sepsis, infection, non-specific presentation, or other specific presentation. Main outcome measures: Proportion of cases prioritised at the four hospitals; diagnostic accuracy for the sepsis-3 definition of sepsis and receiving urgent treatment (primary reference standard); daily number of cases with and without sepsis prioritised at a large and a small hospital; the minimum treatment effect associated with prioritisation at which each strategy would be cost-effective, compared to no prioritisation, assuming willingness to pay £20,000 per quality-adjusted life-year gained. Results: Data from 95,022 episodes involving 71,204 patients across four hospitals showed that most early warning scores operating at their pre-specified thresholds would prioritise more than 10% of cases when applied to non-specific attendances or all attendances. Data from 12,870 episodes at one hospital identified 348 (2.7%) with the primary reference standard. The National Early Warning Score, version 2 (NEWS2), had the highest area under the receiver operating characteristic curve when applied only to patients with a paramedic diagnostic impression of sepsis or infection (0.756, 95% confidence interval 0.729 to 0.783) or sepsis alone (0.655, 95% confidence interval 0.63 to 0.68). None of the strategies provided high sensitivity (> 0.8) with acceptable positive predictive value (> 0.15). NEWS2 provided combinations of sensitivity and specificity that were similar or superior to all other early warning scores. Applying NEWS2 to paramedic diagnostic impression of sepsis or infection with thresholds of > 4, > 6 and > 8 respectively provided sensitivities and positive predictive values (95% confidence interval) of 0.522 (0.469 to 0.574) and 0.216 (0.189 to 0.245), 0.447 (0.395 to 0.499) and 0.274 (0.239 to 0.313), and 0.314 (0.268 to 0.365) and 0.333 (confidence interval 0.284 to 0.386). The mortality relative risk reduction from prioritisation at which each strategy would be cost-effective exceeded 0.975 for all strategies analysed. Limitations: We estimated accuracy using a sample of older patients at one hospital. Reliable evidence was not available to estimate the effectiveness of prioritisation in the decision-analytic modelling. Conclusions: No strategy is ideal but using NEWS2, in patients with a paramedic diagnostic impression of infection or sepsis could identify one-third to half of sepsis cases without prioritising unmanageable numbers. No other score provided clearly superior accuracy to NEWS2. Research is needed to develop better definition, diagnosis and treatments for sepsis. Study registration: This study is registered as Research Registry (reference: researchregistry5268). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/136/10) and is published in full in Health Technology Assessment; Vol. 28, No. 16. See the NIHR Funding and Awards website for further award information.


Sepsis is a life-threatening condition in which an abnormal response to infection causes heart, lung or kidney failure. People with sepsis need urgent treatment. They need to be prioritised at the emergency department rather than waiting in the queue. Paramedics attempt to identify people with possible sepsis using an early warning score (based on simple measurements, such as blood pressure and heart rate) alongside their impression of the patient's diagnosis. They can then alert the hospital to assess the patient quickly. However, an inaccurate early warning score might miss cases of sepsis or unnecessarily prioritise people without sepsis. We aimed to measure how accurately early warning scores identified people with sepsis when used alongside paramedic diagnostic impression. We collected data from 71,204 people that two ambulance services transported to four different hospitals in 2019. We recorded paramedic diagnostic impressions and calculated early warning scores for each patient. At one hospital, we linked ambulance records to hospital records and identified who had sepsis. We then calculated the accuracy of using the scores alongside diagnostic impression to diagnose sepsis. Finally, we used modelling to predict how many patients (with and without sepsis) paramedics would prioritise using different strategies based on early warning scores and diagnostic impression. We found that none of the currently available early warning scores were ideal. When they were applied to all patients, they prioritised too many people. When they were only applied to patients whom the paramedics thought had infection, they missed many cases of sepsis. The NEWS2, score, which ambulance services already use, was as good as or better than all the other scores we studied. We found that using the NEWS2, score in people with a paramedic impression of infection could achieve a reasonable balance between prioritising too many patients and avoiding missing patients with sepsis.


Subject(s)
Early Warning Score , Emergency Medical Services , Sepsis , Adult , Humans , Cost-Benefit Analysis , Retrospective Studies , Sepsis/diagnosis
12.
Front Pediatr ; 12: 1207609, 2024.
Article in English | MEDLINE | ID: mdl-38333086

ABSTRACT

Background: There is an increasing consensus on the relevance of musculoskeletal fitness for health throughout the life cycle, requiring evaluation approaches and description of results capable of characterizing different age groups and body sizes. This study aimed to describe the musculoskeletal fitness of young Portuguese people aged 10-18 through handgrip strength (HGS) and vertical jump power (VJP) and investigate differences between the sexes. Methods: The sample included 736 participants (359 girls recruited from schools. HGS (kg) was assessed using a handheld dynamometer, and VJP (W) was assessed using a force platform; both measurements were standardized for body mass. Results: Higher HGS and VJP were observed in boys than in girls from 13 years old (13 years: p ≤ 0.05; 14-18 years: p ≤ 0.001), with no significant differences before this age. The percentile distributions of HGS and VJP are described for each sex using the lambda, mu, sigma (LMS) method. The pattern of development of these variables as a function of age is presented. Conclusions: Handgrip strength and vertical jump power show differences between the sexes from 13 years of age and similar trajectories to populations in other countries in the same age group.

13.
Mod Pathol ; 37(1): 100384, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37972928

ABSTRACT

Tumor-agnostic testing for NTRK1-3 gene rearrangements is required to identify patients who may benefit from TRK inhibitor therapies. The overarching objective of this study was to establish a high-quality pan-TRK immunohistochemistry (IHC) screening assay among 18 large regional pathology laboratories across Canada using pan-TRK monoclonal antibody clone EPR17341 in a ring study design. TRK-fusion positive and negative tumor samples were collected from participating sites, with fusion status confirmed by panel next-generation sequencing assays. Each laboratory received: (1) unstained sections from 30 cases of TRK-fusion-positive or -negative tumors, (2) 2 types of reference standards: TRK calibrator slides and IHC critical assay performance controls (iCAPCs), (3) EPR17341 antibody, and (4) suggestions for developing IHC protocols. Participants were asked to optimize the IHC protocol for their instruments and detection systems by using iCAPCs, to stain the 30 study cases, and to report the percentage scores for membranous, cytoplasmic, and nuclear staining. TRK calibrators were used to assess the analytical sensitivity of IHC protocols developed by using the 2 reference standards. Fifteen of 18 laboratories achieved diagnostic sensitivity of 100% against next-generation sequencing. The diagnostic specificity ranged from 40% to 90%. The results did not differ significantly between positive scores based on the presence of any type of staining vs the presence of overall staining in ≥1% of cells. The median limit of detection measured by TRK calibrators was 76,000 molecules/cell (range 38,000 to >200,000 molecules/cell). Three different patterns of staining were observed in 19 TRK-positive cases, cytoplasmic-only in 7 samples, nuclear and cytoplasmic in 9 samples, and cytoplasmic and membranous in 3 samples. The Canadian multicentric pan-TRK study illustrates a successful strategy to accelerate the multicenter harmonization and implementation of pan-TRK immunohistochemical screening that achieves high diagnostic sensitivity by using laboratory-developed tests where laboratories used centrally developed reference materials. The measurement of analytical sensitivity by using TRK calibrators provided additional insights into IHC protocol performance.


Subject(s)
Neoplasms , Humans , Immunohistochemistry , Canada , Antibodies, Monoclonal , Receptor, trkA/genetics , Oncogene Proteins, Fusion/genetics , Biomarkers, Tumor/genetics
14.
Chinese Journal of School Health ; (12): 309-312, 2024.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-1013485

ABSTRACT

Abstract@#In the context of frequent public health events, effective school health education is an important measure to improve students health literacy and public health system of China. The study examined the National Health Education Standards in the U.S., based on a literature review and comparative analysis, to provide guidance for China. Using the method of liberature riview paper interprets the curriculum of National Health Education Standards in the U.S. and provides a mirror for China. Health Education standards in the U.S. are characterized by their academic quality, standardized framework, assessment program, equity principles, and other components. A mirror for China includes promoting the construction of the standards based health education curriculum, developing the skills based health education curriculum system, and constructing a performancebased comprehensive evaluation system.

15.
Chinese Journal of School Health ; (12): 277-282, 2024.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-1012520

ABSTRACT

Objective@#To evaluate the performance of four simplified screening methods of elevated blood pressure commonly used among children and adolescents according to Chinese guidelines for prevention and treatment of hypertension (revised in 2018), so as to provide a reference for the early detection of the elevated blood pressure among children and adolescents.@*Methods@#Stratified cluster random sampling method was used to monitor the physical fitness of 5 211 children and adolescents in a city of Shanxi Province from October to November 2021. Chinese guidelines for prevention and treatment of hypertension was considered as gold standard, and sensitivity, specificity, area under the curve (AUC) and Kappa value were calculated to evaluate the screening effectiveness of formula method, height specific method, age group specific method, sex and age specific method for screening elevated blood pressure.@*Results@#The detection rates of elevated blood pressure among children and adolescents screened by gold standard, formula method, height specific method,age group specific method, sex and age specific method were 21.9%, 24.0%, 21.1%, 24.5% and 20.2%, respectively. There was no significant difference between prevalence of elevated blood pressure screened by formula method, sex and age specific method and gold standard( χ 2=1.21, 1.41, P >0.05), whereas height specific method and age group specific method had significant differences with gold standard ( χ 2=20.39, 67.09, P <0.05). AUC was the largest for height specific method [0.94(95% CI =0.93-0.95)], and the smallest for age group specific method [0.87(95% CI = 0.86 -0.88)]. The Kappa values of height specific method (0.89) and sex and age specific method (0.89) were both greater than 0.85 , which were more consistent with the screening effectiveness of gold standard. When comparing by sex, age and body mass index (BMI), the screening effectivenesses were consistent with the overall in boys, 6-11 years and normal body weight groups, while the screening effectivenesses were different in girls, 12-17 years, overweight and obese groups. The AUC (0.87), Kappa value (0.71) and sensitivity (82.33%) of age group specific method were the lowest and the screening effectiveness was the worst.@*Conclusion@#Height specific method is more effective and can be used for early identification and self detection of blood pressure abnormalities among children and adolescents.

16.
Chinese Journal of School Health ; (12): 273-276, 2024.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-1012519

ABSTRACT

Objective@#To explore two visual acuity standards for examining uncorrected visual acuity (UCVA) to define poor vision in lower grade elementary school students, and to compare the difference of screening myopia rates when combined with non cycloplegic auto refraction (NCAR), so as to provide a scientific basis for standardizing UCVA examination methods using CAR as the gold standard of authenticity and reliability.@*Methods@#From March 22nd to April 9th, 2023, a total of 549 first and second grade students aged 7-8 years from a primary school in Hefei City were selected for the study by convenient cluster sampling method. Two methods were employed for UCVA examination:the first method involved charts where the student could not make mistakes in identifying at least half of the characters per line (V1), and the second method used charts with character sizes ranging from 4.0 -4.5, 4.6-5.0 and 5.1-5.3, without allowing 1, 2 and 3 errors per line (V2). While NCAR was performed, then 187 students underwent CAR examination. Paired Wilcoxon rank-sum test and McNemar test were used to compare the differences between V1 and V2 methods in defining poor vision and screening myopia rates. Using CAR as the gold standard, the authenticity and reliability of defining screening myopia rates through the combination of V1 and V2 methods along with NCAR were evaluated.@*Results@#The UCVA examination results for V1 and V2 showed statistically significant differences in both the right eye [5.0(4.9,5.0), 4.9(4.8,5.0)] and the left eye [ 5.0 (4.9,5.0), 4.9(4.8,5.0)] ( Z=-13.95, -13.34, P <0.01). The detection rates of poor vision for the right eye were 43.53% for V1 and 63.21% for V2, and the left eye with 44.08% for V1 and 62.11% for V2, with statistically significant differences ( χ 2= 106.01 , 95.09, P <0.01). When screening myopia rates were assessed for UCNA methods combined with NCAR, the right eye rates were 21.49% for V1 and 24.59% for V2, and the left eye rates were 21.31% for V1 and 23.13% for V2, with statistically significant differences ( χ 2=15.06, 8.10, P <0.01). Using CAR as the gold standard, the detection rates in the right eye and left eye were 16.58 % and 17.11%, respectively. The Youden indices for defining screening myopia in the right eye were 0.80 for V1 and 0.79 for V2, and the left eye with 0.85 for V1 and 0.83 for V2. The agreement rates for the right eye were 91.98 % for V1 and 89.30% for V2, and the left eye with 94.12% for V1 and 91.98% for V2. The Kappa values for the right eye were 0.73 for V1 and 0.67 for V2, and the left eye with 0.81 for V1 and 0.75 for V2.@*Conclusions@#Authenticity and reliability of two UCVA examination methods combined with NCAR in defining screening myopia are higher in V1 than V2 methods. It is recommended to unify the visual acuity examination methods by requiring the correct identification of more than half of the total number of visual markers in a row.

17.
Chinese Journal of School Health ; (12): 157-161, 2024.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-1012459

ABSTRACT

Abstract@#To help children and adolescents grow up healthily, using literature, comparative analysis and other research methods, the historical development of Japan s physical fitness assessment system for children and adolescents are analyzed for the content structure of the latest version of its physical fitness assessment system (Sports adaptability assessment Ⅱ). On the basis of this analysis, some practical suggestions are proposed for improving the National Physical Fitness Standards for Students in China, such as adding a physical fitness assessment system for preschoolers, grouping the test subjects by age and setting common test indicators for males and females. Thus, the improved National Student Physical Fitness Standard is more aligned with the physical and mental growth patterns of Chinese children and adolescents.

18.
Article in Spanish | LILACS-Express | LILACS, BNUY | ID: biblio-1556987

ABSTRACT

Introducción: la gastrosquisis congénita (GC) es una patología con creciente demanda asistencial. Atentos a esto, en el Centro Hospitalario Pereira Rossell (CHPR) se implementó un protocolo de cuidados llevado adelante por un equipo multidisciplinario. En este trabajo nos proponemos evaluar el impacto en la sobrevida y morbilidad a partir de su aplicación. Material y método: estudio comparativo tipo antes y después de pacientes portadores de GC (n = 47), 29 de una cohorte histórica (GH) y 18 de una cohorte posaplicación de protocolo (GP). Con edad gestacional ≥ 36 semanas y peso al nacer ≥ 2500 g, asistidos en el CHPR entre los años 2016 y 2021. Resultados: no se observaron diferencias perinatales entre ambos grupos, ni en la incidencia de GQ complicadas. En el GP se observó mayor incidencia de cierre abdominal precoz (p < 0,01), menor necesidad de realización de silo quirúrgico (p < 0,01), menor tiempo de administración de ventilación mecánica (p = 0,03), de uso total de opioides (p < 0,01), de administración de nutrición parenteral (p = 0,03), e inicio más temprano de la alimentación enteral (p = 0,03). Sin diferencias en la sobrevida al egreso hospitalario. Conclusiones: la aplicación de un protocolo estandarizado se asoció a una reducción significativa en el tiempo de cierre abdominal, de ventilación mecánica, nutrición parenteral y de opioides, con inicio más precoz de la nutrición enteral.


Summary: Introduction: congenital gastroschisis is an increasingly demanded pathology, therefore a care protocol was implemented at the Pereira Rossell Pediatric Hospital (CHPR), and it has been carried out by a multidisciplinary team. In this paper, we aim at assessing the morbidity and mortality impact of survival and morbidity of this application. Materials and Methods: comparative before and after study of a historical cohort (GH, n=29) versus a post-protocol application cohort (GP, n=18), in patients with a gestational age ≥36 weeks and birth weight ≥2500 grams assisted in CHPR between 2016-2021. Results: no perinatal differences were observed between both groups or in the incidence of complicated GQ. In the GP, a higher incidence of early abdominal closure was decreased (GH 3.4% vs GP 67%, p<0.01), less need to perform a surgical silo (GH 100% vs GP 33%, p<0.01 ), shorter mechanical ventilation administration time (GH 2 days vs GP 0.5 days, p=0.03), total use of opioids (GH 3.5 days vs GP 7 days, p<0.01) , of administration of parenteral nutrition (GH 24.5 days vs GP 20 days, p=0.03), and earlier start of enteral feeding (GH 11 days vs GP 7 days, p=0.03). No differences in survival after hospital discharge (93% vs 89%, p=0.63). Conclusions: the application of a standardized protocol was linked to a significant reduction in the time of abdominal closure, mechanical ventilation, parenteral nutrition, and opioids, with earlier initiation of enteral nutrition.


Introdução: a gastrosquise congênita (GC) é uma patologia com demanda crescente de atendimento e, porém, foi implementado um protocolo de atendimento por equipe multidisciplinar no Centro Hospitalar Pediátrico Pereira Rossell (CHPR). Neste trabalho propomos avaliar o impacto na mortalidade e morbidade depois de sua aplicação. Material e Métodos: estudo comparativo antes e depois de pacientes com CG (n=47), sendo 29 de uma coorte histórica (GH) e 18 de uma coorte pós-aplicação de protocolo (GP). Idade gestacional ≥ 36 semanas e peso ao nascer ≥ 2.500 gramas atendidos no CHPR entre os anos de 2016-2021. Resultados: não foram observadas diferenças perinatais entre os dois grupos ou na incidência de QG complicada. No GP observou-se maior incidência de fechamento abdominal precoce (p<0,01), menor necessidade de silos cirúrgicos (p<0,01), menor tempo de administração de ventilação mecânica (p=0,03) e uso total de opioides. (p<0,01), administração de nutrição parenteral (p=0,03) e início mais precoce da alimentação enteral (p=0,03). Não houve diferenças na sobrevivência até a alta hospitalar. Conclusões: a aplicação de protocolo padronizado foi associada à redução significativa do tempo de fechamento abdominal, ventilação mecânica, nutrição parenteral e opioides, com início mais precoce da nutrição enteral.

19.
Saudi Pharm J ; 31(12): 101825, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37965488

ABSTRACT

India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying high-quality and affordable medicines across the globe. Ensuring the quality and safety of the marketed medicinal products is one of the most important components of the drug regulatory framework and assessment of the quality of medicines is usually achieved by referring to the public standards of the official Pharmacopoeia. In India, the Indian Pharmacopoeia (IP) is published at regular intervals to fulfill the requirements of the Drugs and Cosmetics Act, 1940 to ensure the quality of medicines being manufactured and/or marketed in India. The present article aims to provide an overview of the history of the IP, its standards-setting process, and the current status of monographs in the 9th edition of the IP 2022. Special focus is placed on the newly added and upgraded general chapters and monographs within the IP 2022. There are a total of 223 general chapters and 3152 drug monographs available under various categories in the IP 2022. This study also highlights a total of 92 new drug monograph additions and 412 monograph revisions in the IP 2022. It is anticipated that the standards laid down in the IP 2022 will play an imperative role in delivering quality medicines to patients within and outside India.

20.
J Med Radiat Sci ; 2023 Nov 27.
Article in English | MEDLINE | ID: mdl-38009579

ABSTRACT

INTRODUCTION: The International Atomic Energy Agency (IAEA) introduced a Quality Management Audits in Nuclear Medicine (QUANUM) programme, to improve nuclear medicine practice standards aligned with international standards through self-assessments. The absence of quality management audits in nuclear medicine departments could potentially result in a compromise in the safety and quality of patient care. To date, there is no evidence that quality audits have been conducted in nuclear medicine departments of this middle-income country. This quality audit, therefore, assessed conformance to the IAEA QUANUM programme in four nuclear medicine departments. METHODS: The study adopted a quantitative methodological exploratory approach. The IAEA QUANUM programme was used to audit nuclear medicine services' overall activity such as clinical practice, management, radiopharmacy, general and radiation safety, quality assurance, operations and services. The data was collected via document analysis in four nuclear medicine department identified as Sites A-D. RESULTS: Overall results showed that Site A conformed with 247 out of 370 (67%) counts and non-conformed with 123 out of 370 (33%) counts whilst Site B conformed with 205 out of 342 (60%) counts and non-conformed with 137 out of 342 counts (40%). Site C conformed with 259 out of 345 (75%) counts and non-conformed with 86 out of 345 (25%) counts. Site D conformed with 166 out of 349 (48%) counts and non-conformed with 183 out of 349 (52%) counts. The study yielded 125 overall recommendations. CONCLUSIONS: All the sites demonstrated good compliance to international standards in radionuclide therapy. Site A complied poorly in strategies and policies, whilst Site B complied poorly in quality control of equipment. Site C showed poor compliance to human resource development and Site D showed aspects pertaining to administration and management as well as evaluation of quality systems.

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