Validation study of postoperative liver failure and mortality risk scores after liver resection for perihilar cholangiocarcinoma

Background:Surgery for perihilar cholangiocarcinoma(PHCC)remains a challenging procedure with high morbidity and mortality.The Academic Medical Center(Amsterdam UMC)and Memorial Sloan Kettering Cancer Center proposed a postoperative mortality risk score(POMRS)and post-hepatectomy liver failure score(PHLFS)to predict patient outcomes.This study aimed to validate the POMRS and PHLFS for PHCC patients at Hokkaido University.Methods:Medical records of 260 consecutive PHCC patients who had undergone major hepatectomy with extrahepatic bile duct resection without pancreaticoduodenectomy at Hokkaido University between March 2001 and November 2018 were evaluated to validate the PHLFS and POMRS.Results:The observed risks for PHLF were 13.7%,24.5%,and 39.8%for the low-risk,intermediate-risk,and high-risk groups,respectively,in the study cohort.A receiver-operator characteristic(ROC)analysis revealed that the PHLFS had moderate predictive value,with an analysis under the curve(AUC)value of 0.62.Mortality rates based on the POMRS were 1.7%,5%,and 5.1%for the low-risk,intermediate-risk,and high-risk groups,respectively.The ROC analysis demonstrated an AUC value of 0.58.Conclusions:This external validation study showed that for PHLFS the threshold for discrimination in an Eastern cohort was reached(AUC>0.6),but it would require optimization of the model before use in clinical practice is acceptable.The POMRS were not applicable in the eastern cohort.Further external validation is recommended.

Snow and sea ice thermodynamics in the Arctic:Model validation and sensitivity study against SHEBA data

Evolution of the Arctic sea ice and its snow cover during the SHEBA year were simulated by applying a high-resolution thermodynamic snow/ice model （HIGHTSI）. Attention was paid to the impact of albedo on snow and sea ice mass balance, effect of snow on total ice mass balance, and the model vertical resolution. The SHEBA annual simulation was made applying the best possible external forcing data set created by the Sea Ice Model Intercomparison Project. The HIGHTSI control run reasonably reproduced the observed snow and ice thickness. A number of albedo schemes were incorporated into HIGHTSI to study the feedback processes between the albedo and snow and ice thickness. The snow thickness turned out to be an essential variable in the albedo parameterization. Albedo schemes dependent on the surface temperature were liable to excessive positive feedback effects generated by errors in the modelled surface temperature. The superimposed ice formation should be taken into account for the annual Arctic sea ice mass balance.

Validation of Peek Acuity application in pediatric screening programs in Paraguay

AIM： To validate the Peek Acuity mobile phone application in pediatric populations and compare its utility, both economic and diagnostic, against conventional screening methods using a pediatric ophthalmologist examination as the gold standard.METHODS： A cohort of 393 subjects from Fernando de la Mora, Paraguay（ages 6-16 y） were enrolled in the study. Subjects were randomly assigned a starting screening modality among： Peek Acuity, a single line of tumbling E optotypes set at 20/40, and Spot Vision Screener. Once completing the first screening modality, the subjects completed the two remaining techniques. Referral criteria were established based on the most current American Association of Pediatric Ophthalmology and Strabismus（AAPOS） recommendations： 20/40 for Peek Acuity and the tumbling E, and refractive error detection for the Spot Vision Screener. Subjects that failed to achieve the cutoff for any of the three screening techniques or subjects that passed the screening but were randomly selected to perform a comprehensive eye exam to determine the false negative rate, were evaluated by a pediatric ophthalmologist. This evaluation was considered the gold standard, and included vision assessment by a Snellen chart, strabismus evaluation, and cycloplegic refraction with dilated fundoscopy.RESULTS： We obtained 48% sensitivity, 83% specificity, 43% positive predictive value, and 86% negative predictive value for Peek Acuity＇s ability to refer compared to evaluation by a pediatric ophthalmologist, failing to achieve a desired sensitivity for implementation. Peek Acuity trended to overestimate the subject＇s visual acuity, providing a higher visual acuity that would not indicate referral for a comprehensive eye examination. However, its high specificity accurately predicted a significant number of children who did not need further evaluation. When comparing the three screening methods, no single screening modality outperformed the others. Peek Acuity represented a technology that was economically feasible compared to other screening modalities in low income settings, due to the prevalence of cell phone use.CONCLUSION： Peek Acuity represents an efficient tool that has potential for implementation in school screenings with different strategies aimed at pediatric populations due to its low cost and high specificity. An increase in sensitivity would improve detection of children with refractive errors.

Evaluation of joint awareness after acetabular fracture:Validation of the Forgotten Joint Score according to the COSMIN checklist protocol

BACKGROUND A fracture of the acetabulum is an uncommon,but serious injury.Established outcome tools do not reflect the patient’s perspective after fracture of the hip joint.Originally designed for post-arthroplasty patients,the Forgotten Joint Score(FJS)is a patient-reported outcome measurement(PROM)tool evaluating the diseasespecific health-related quality of life(HR-QoL).AIM To validate the FJS in patients after acetabular fracture.METHODS In a prospective mono-centric cohort study,we evaluated 100 patients at mean 5.2±3.6 years after a fracture of the acetabulum.The validation study followed the complete COSMIN checklist protocol.For calculation of convergent validity,we used the Tegner-Activity Scale,the Western Ontario and McMaster Universities Osteoarthritis Index,the EuroQol-5D,and a subjective rating of change as an anchor variable.RESULTS We confirmed good internal consistency with a Cronbach‘s alpha of 0.95.With an intraclass correlation coefficient of 0.99(95%CI:0.97,0.99),test-retest reliability of the FJS was excellent.Correlation coefficients between the questionnaires were moderate to high ranging from|0.56|to|0.83|(absolute value).No relevant floor or ceiling effects occurred.Standard error of measurement was 3.2 and smallest detectable change(SDC)was 8.8.Thus,changes greater than 8.8 points between two assessments denote a real change in FJS.CONCLUSION The FJS is a valid and reliable tool for evaluation of patient-reported outcome in posttraumatic condition after acetabular fracture.The SDC indicating a real clinical improvement was 8.8 points in the FJS.We could confirm responsiveness of the FJS and found no relevant floor-or ceiling effects.

Validation of the Trail Making Test B for the Cognitive Assessment of Patients with Cancer in Palliative Care

Introduction: Cognitive impairment is common in patients with cancer;however, studies examining the adaptation and validation of instruments for use in patients with cancer are scarce. Purpose: The purpose of this study was to validate the Trail Making Test B (TMT-B) for use in patients with cancer. Methods: Ninety-four outpatients receiving palliative treatment and 39 healthy companions were assessed. Patients were tested with the TMT-B and answered questions regarding the presence and intensity of pain, fatigue, quality of sleep, anxiety, and depression, at two time points with a 7-day inter-assessment interval. Results: The instrument discriminated between patients, who were slower, and healthy companions with respect to the time required to complete the test, but not in terms of the number of errors. The test was stable for the healthy companions across the two assessments in terms of time to complete the TMT-B and the number of errors;for patients, the instrument was stable only for the number of errors. Performance on the TMT-B did not correlate with pain, fatigue, depression, anxiety, or sensation of rest. Conclusions: TMT-B cannot be considered fully validated. Further studies incorporating and comparing other instruments evaluating executive function and mental flexibility are needed.

Development of a Training Textbook for Countermeasures to “Verbal Abuse, Physical Assault, and Harassment in Pediatric Medical Settings”

Background: Recently, abuse, assault, and harassment in pediatric medical settings have become more serious. We extracted typical problems from a nationwide simultaneous survey on abuse in the pediatric medical field and developed a training textbook to simulate or discuss these issues with colleagues. This study aimed to confirm the validity and usability of the contents of this training textbook. Methods: The textbook was mailed to the heads of 51 medical institutions affiliated with the Society of Ambulatory and General Pediatrics of Japan (SAGPJ) and the participants of the SAGPJ online workshop, who were asked to evaluate the textbook using a three-point scale to answer the following questions and provide opinions and impressions about the textbook. Q1. Do you think the whole content and structure of this textbook are useful? Q2. Would you use this textbook as a training textbook for all staff at your facility? A simple tabulation was performed on the evaluation using a three-point scale, while content analysis was performed on the opinions and impressions of the participants. Results: In response to Q1 and Q2, all 63 staff members from 55 facilities answered “3: Yes.” Opinions and impressions on the training textbook included “I think it can be used for workplace training” and “it is useful for exchanging various opinions among staff members and gaining a common opinion.” Conclusion: We developed a training textbook on abuse, assault, and harassment in pediatric medical settings based on a nationwide survey and confirmed the validity and usability of its contents.

Ten Rules of Foot Care—The Development of a Short Questionnaire for Patients with Diabetes

Objective: The aim of this study was to develop and validate a questionnaire for patients with diabetes to assess the foot self-care. Methods: A validation study was carried out in a sample of 200 patients with diabetes. Item analyses included the assessment of difficulty index, discrimination capacity and the correlation of items with the total score of the questionnaire. Factor analysis was used to test construct validity. Test-retest reliability was assessed with a sample of 31 patients. Criterion validity was determined by comparing the scores of patients with a history of foot ulcers with the scores of patients without this complication. Results: The internal consistency assessed by the Cronbach’s alpha (0.731) and test-retest reliability (r = 0.714, p = 0.001) for all sections were acceptable. Factor analysis revealed three factors: foot care, footwear and foot-damaging behavior, which explained 54.34% of the variance. All items had factor loading of greater than 0.4. Patients with diabetic neuropathy had a lower score after completing the foot care education questionnaire (Mann-Whitney U, p < 0.001). Conclusion: This questionnaire meets the reliability and validity conditions necessary for its application in our patients with diabetes.

Accuracy of ultrasound elastography for predicting breast cancer response to neoadjuvant chemotherapy: A systematic review and meta-analysis

BACKGROUND Several studies have reported the prognostic value of ultrasound elastography(UE)in patients receiving neoadjuvant chemotherapy(NACT)for breast cancer.However,the assessment of parameters differed between shear-wave elastography and strain elastography in terms of measured elasticity parameter and mode of imaging.It is important,therefore,to assess the accuracy of the two modes of elastography.AIM To assess the accuracy of UE for predicting the pathologic complete response(pCR)in breast cancer patients following NACT.METHODS A comprehensive and systematic search was performed in the databases of MEDLINE,EMBASE,SCOPUS,PubMed Central,CINAHL,Web of Science and Cochrane library from inception until December 2020.Meta-analysis was performed using STATA software“Midas”package.RESULTS A total of 14 studies with 989 patients were included.The pooled sensitivities were 86%[95%confidence interval(CI):76%-92%]for UE,77%(95%CI:68%-84%)for shear-wave elasto-graphy,and 92%(95%CI:73%-98%)for strain-wave elastography.The pooled score specificities were 86%(95%CI:80%-90%)for UE,84%(95%CI:72%-91%)for shear-wave elasticity,and 87%(95%CI:81%-92%)for strain-wave elastography.A significant heterogeneity was found among studies based on the chi-square test results and an I2 statistic>75%.CONCLUSION Strain-wave type of UE can accurately predict the pCR following NACT amongst breast cancer patients.Studies exploring its accuracy in different ethnic populations are required to strengthen the evidence.

The effectiveness of the TAX 327 nomogram in predicting overall survival in Chinese patients with metastatic castration-resistant prostate cancer

Based on the results of TAX 327, a nomogram was developed to predict the overall survival of metastatic castration-resistant prostate cancer （mCRPC） after first-line chemotherapy. The nomogram, however, has not been validated in an independent dataset, especially in a series out of clinical trials. Thus, the objective of the current study was to validate the TAX 327 nomogram in a community setting in China. A total of 146 patients with mCRPC who received first-line chemotherapy （docetaxel or mitoxantrone） were identified. Because clinical trials are limited in China's Mainland, those patients did not receive investigational treatment after the failure of first-line chemotherapy. The predicted overall survival rate was calculated from the TAX 327 nomogram. The validity of the model was assessed with discrimination, calibration and decision curve analysis. The median survival of the cohort was 21 months （docetaxel） and 19 months （mitoxantrone） at last follow-up. The predictive c-index of the TAX 327 nomogram was 0.66 （95% CI： 0.54-0.70）. The calibration plot demonstrated that the 2-year survival rate was underestimated by the nomogram. Decision curve analysis showed a net benefit of the nomogram at a threshold probability greater than 30%. In conclusion, the present validation study did not confirm the predictive value of the TAX 327 nomogram in a contemporary community series of men in China, and further studies with a large sample size to develop or validate nomograms for predicting survival and selecting therapies in advanced prostate cancer are necessary.

Disordered eating behaviour and eating disorder among adolescents with type 1 diabetes:An integrative review

BACKGROUND Type 1 diabetes(DT1)in adolescents brings behavioural changes,altered nutritional habits,and eating disorders.AIM To identify and analyze the validated instruments that examine the disordered eating behaviour and eating disorders among adolescents with DT1.METHODS An integrative review was accomplished based on the following databases:PubMed,LILACS,CINAHL,Scopus,Web of Science,and Reference Citation Analysis(RCA),including publications in Portuguese,English,or Spanish,without time limit and time published.RESULTS The main instruments to evaluate disordered eating behaviour were The Diabetes Eating Problem Survey-Revised,The Diabetes Eating Problem Survey,and the eating attitudes test-26,and for eating disorders the main instruments used were The Bulimic Investigation Test of Edinburgh,The Binge Eating Scale,The Child Eating Disorder Examination,The five questions of the(Sick,Control,One,Fat and Food),and The Mind Youth Questionnaire.These instruments showed an effect in evaluating risks regarding nutritional habits or feeding grievances,with outcomes related to weight control,inadequate use of insulin,and glycaemia unmanageability.We did not identify publication bias.CONCLUSION Around the world,the most used scale to study the risk of disordered eating behaviour or eating disorder is The Diabetes Eating Problem Survey-Revised.International researchers use this scale to identify high scores in adolescents with DT1 and a relationship with poorer glycemic control and psychological problems related to body image.

Multidimensional Pain Inventory(MPI):Adaptation to Orthodontic Patients and Its Psychometric Properties

Background: Pain perception may result from orthodontic treatment and should be considered in clinical management. Its assessment should not be limited to the intensity of perceived pain but should also consider the psychosocial and behavioral aspects involved. Objective: The aims of this study were to adapt and validate the Multidimensional Pain Inventory (MPI) for orthodontic patients, and present a proposal to calculate an overall score of the pain-related aspects and compare these scores with the usual methodology used. Methods: Face validity of the MPI was estimated and orthodontic version (MPI-Orthodontic) was developed. Factorial validity was evaluated by confirmatory analysis. Convergent and discriminant validity and reliability were estimated. The fit of Second-Order Hierarchical Models was estimated. Concurrent validity of MPI-Orthodontic was evaluated against the Visual Analogue Scale. Invariance of the factorial models was evaluated for independent samples and according to sex and age. Overall score was calculated using the matrix of regression weights and compared to simple arithmetic mean. Results: 507 individuals (63.3% women;age: 26.32 (SD = 11.70) years) participated. For the fit of Part I (psychosocial aspects) of the MPI-Orthodontic, it added correlation between two items and excluded one item;for Part II (behavioral aspects) two items were excluded. The models presented adequate fit to the sample. Reliability was adequate. MPI-Orthodontic presented invariance for independent samples and adequate concurrent and divergent validity. Score obtained with the simple arithmetic mean was overestimated for Part I and underestimated for Part II. Conclusion: MPI-Orthodontic was valid, reliable and invariant for the evaluation of the orthodontic pain. It is recommended to calculate overall weighted scores for pain assessment.

Clinical and radiographic predictors in diagnosing sputum smear- negative pulmonary tuberculosis in HIV-negative patients： a cross- sectional study in China

Background In county-level tuberculosis （TB） dispensaries in China,the accurate diagnosis of sputum smear-negative pulmonary tuberculosis （SNPT） needs to be improved by developing and validating clinical and radiographic predictors.Methods The study was conducted simultaneously in three counties per province in Chongqing Municipality and Liaoning Province in China between May 2005 and May 2006.A total of 432 new SNPT patients who are HIV-negative and more than 15 years old diagnosed by expert panels in county-level TB dispensaries were recruited.Their sputum samples were collected for culture before anti-TB treatment,and the treatment outcomes （changes of X-rays） were followed up at the end of the 6th month.Results Of the 432 SNPT patients,sputum culture positive （9.7%） or culture negative with good changes of X-rays at the end of the 6th month （73.6%） was validated as SNPT.Four predictive variables were associated with validated SNPT in the multivariate logistic regression model：age ≤55 years old （odds ratio （OR） 5.66; 95% CI 2.69-11.91）,〉60 days of cough （OR 3.73; 95% CI 1.10-12.65）,≥10% of pulmonary consolidation in the lungs （OR 5.40; 95% CI 2.90-10.06）,and pulmonary consolidation in the upper lobe anterior segment （OR 3.00; 95% CI 1.57-5.72）.The area under the receiver operating characteristic curve of the model was 0.77 （95% CI 0.71-0.83）.Conclusion Four predictors of clinical and radiological characteristics that had a good diagnostic performance of SNPT deserve to be recommended as index indicators of SNPT diagnosis in county-level TB dispensaries in China.

Validity and Reliability of a Mental Health Recovery Checklist for Young Adults

The purpose of the present study is to evaluate the internal consistency and construct validity of a self-report checklist measuring clinical mental health recovery across six key domains:family and relationships,occupation and school,physical health,mental health,spirituality,and social support systems.The Mental Health Recovery Checklist(MHRC)was developed at The Dorm,an intensive outpatient mental health treatment program for young adults in New York,NY,and Washington DC that services individuals between the ages of 18 and 35 years old.The present study is cross-sectional,as data were pulled from clients’records who were discharged between January 2018 and May 2023.Pearson Correlations and Cronbach’s alpha were used to determine scale reliability.To establish validity,an Exploratory Factor Analysis(EFA)was conducted to assess a single-factor model using Principal Axis Factoring.Cronbach’s alpha was high(α=0.88),indicating good reliability.In the EFA,all items loaded strongly on a single factor.The unidimensional structure revealed in the EFA highlights the interconnected nature of various life domains as they pertain to mental health recovery in young adults.Future research is warranted to explore whether there are additional dimensions of mental health recovery that have not been assessed in the present scale.

Validation of the Investigator 24plex QS Kit:a 6-dye multiplex PCR assay for forensic application in the Chinese Han population

The Investigator 24plex QS Kit(QIAGEN,Hilden,Germany)is a 6-dye fluorescent chemistry short tandem repeat(STR)polymerase chain reaction(PCR)amplification system that simultaneously amplifies 20 of the expanded Combined DNA Index System(CODIS)core STR loci,SE33,DYS391,and the standard sex-determining locus,amelogenin,as well as two special internal performance quality sensor controls(QS1 and QS2),which are included in the primer mix to check the PCR performance.This study was designed to be a pilot evaluation of this STR-PCR kit in a Chinese Han population regarding the PCR conditions,sensitivity,precision,accuracy,repeatability,reproducibility,and concordance;tolerance to PCR inhibitors;applicability to real“forensic-type”samples;species specificity;mixture,balance and stutter analyses,and utility in a population investigation.The exhaustive validation studies demonstrated that the Investigator 24plex QS system is accurate,sensitive and robust for STR genotyping.In addition,these genetic markers in the population data in our study indicated that they can also be useful for forensic identification and paternity testing in the Chinese Han population.

The effects of Park sham needles: a pilot study

BACKGROUND： When performing clinical trials involving acupuncture, it can be difficult to choose a placebo control. OBJECTIVE： To validate the Park sham needle for use as a double-blind control intervention. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS： Two different methods were employed. First, a researcher blinded to needle type administered the Park sham or a real needle, chosen at random, on the arms of 16 healthy volunteers. The researcher and the volunteers independently recorded which needle type they thought had been applied at each acupuncture point. Second, 19 patients with shoulder impingement syndrome were randomly assigned to receive acupuncture applied with the real needle or the Park sham needle, once a week for 6 weeks alongside a course of physiotherapy. At the end of the 6 sessions the patients recorded which needle type they thought was being used. The results were analyzed with a Fisher＇s exact test. This study was carried out in the Outpatient Department of Physiotherapy in Chafing Cross Hospital, London, UK, on healthy volunteers and patients with shoulder impingement pain. The age range was 23 to 54 and 22 to 74 years respectively. RESULTS： Of the healthy volunteers, there was no difference （P=0.23） between the number of needles that were correctly （n=43） or incorrectly identified （n=53）. All patients thought that they had received the real needles. The researcher correctly identified all needles that were applied. CONCLUSION： The researcher delivering the acupuncture recognized the needle type. However, both healthy and patient volunteers were blind to the needle type. This demonstrates that the Park sham needle is an effective single-blind control. It should be noted that the number of patients recruited was small and the study was underpowered to detect an effect of treatment.

Forensic Validation Studies of a Novel 35-InDel Multiplex Polymerase Chain Reaction System

Background:A difficulty associated with forensic applications is the detection of degraded biological materials.Due to the large amplicon sizes of short tandem repeat alleles,valid genotyping results cannot be obtained from degraded biological materials.Recently,insertion/deletion(InDel)polymorphisms have been used in forensic applications for their widespread distributions in the human genome,short amplicon sizes,and low mutation rates.Purpose:Human identification InDel panels have mostly been designed for European populations.Therefore,our laboratory independently developed a multiplex polymerase chain reaction(PCR)system with 35 polymorphic InDel loci to be used for human identification in China.Forensic validation studies were conducted on this novel 35-InDel multiplex PCR system.Methods:The 35 InDel loci were screened in the database,and then used with the traditional PCR amplification and capillary electrophoresis platform combined with five-color fluorescence parallel detection technology.Validation studies were performed on this novel panel,including accuracy,repeatability and reproducibility,species specificity,sensitivity,stability,forensic case sample detection,and mixture studies.In addition,forensic efficiency assessments were conducted in populations from different continents.Results:The data of validated studies indicated that the novel 35-InDel panel was accurate,stable,and efficient for forensic purposes.For human identification,the cumulative power of discrimination values for the these 35 InDel loci in East Asian,South Asian,European,American,and African populations were 0.999999999999995,0.999999999999995,0.999999999999971,0.9999999999999960,and 0.999999999998166,respectively.Conclusions:In this study,a set of 35 InDel loci were conducted in a multiplex amplification system for human identification of degraded DNA sample,and this new assay was efficient and stable.The present results suggested that the 35-InDel panel was a reliable tool for forensic use and could be efficiently used for human identification in the East Asian populations.

MP-PIC simulation of circulating fluidized beds using an EMMS based drag model for Geldart B particles

In this study the multiphase particle-in-cell(MP-PIC)method is used for the simulation of two pilot-scale circulating fluidized beds(CFBs)with quartz sand belonging to Geldart’s group B as bed material.The simulations were performed using a homogeneous drag model as well as a structure dependent drag model based on the energy minimization multi-scale method(EMMS).The results are compared with experimental data from literature as well as experiments.The simulations with the EMMS based drag model show a good agreement of the time-averaged axial solids concentration,circulation rate and riser pressure drop.Furthermore,a lower grid sensitivity is observed compared to the homogeneous drag model.In contrast to the conventional drag model a dense bottom zone is predicted by the EMMS based drag model.An overprediction of the solid concentration in the dense bottom zone is presumably due to an overprediction of the cluster diameter that is calculated using an empirical cluster diameter correlation.This shows the necessity for a new meso-scale cluster correlation for the simulation of Geldart B particles.Furthermore,the results of the time-averaged radial solids concentration differ from the expectations of a core-annulus flow indicating that a mesh refinement at the walls is necessary.Finally,the importance of using a realistic particle size distribution is identified.