Validation of a Screening Questionnaire for Chronic Leg Ulcers

2016 ◽  
Vol 15 (4) ◽  
pp. 320-324
Author(s):  
Kian Zarchi ◽  
Peter Theut Riis ◽  
Christine Graversgaard ◽  
Iben M. Miller ◽  
Michael Heidenheim ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Predictive Value ◽  
Large Scale ◽  
Chronic Wounds ◽  
Population Based ◽  
University Hospital ◽  
Leg Ulcers ◽  
Screening Questionnaire ◽  
Item Questionnaire ◽  
Chronic Leg Ulcers

The use of a validated screening questionnaire to identify individuals with chronic leg ulcers allows large-scale population-based studies to be conducted that measure and monitor the prevalence of the disease. The aim of this study was to design and validate such a screening questionnaire to identify patients with chronic leg ulcers. A simple 3-item questionnaire was developed at the Department of Dermatology, University Hospital of Zealand, Denmark. In total, 90 patients attending the department’s outpatient clinic for dermatological diseases and chronic wounds were included in this study. All included participants completed the questionnaire and were subsequently examined by dermatologists. We found that the constructed 3-item questionnaire in this study had a sensitivity and specificity of 95% and 93% and a positive predictive value and negative predictive value of 78% and 95%, respectively. Moreover, we found that the use of the 3-item questionnaire, as compared with a single question, in which the participants were asked whether they currently have a leg ulcer, resulted in significantly higher positive predictive value (+11.6%, P = .035) and specificity (+5.6%, P = .046) of the diagnostic test. Future studies are merited to investigate the diagnostic accuracy of the questionnaire in other populations and settings.

scholarly journals Use of SNP chips to detect rare pathogenic variants: retrospective, population based diagnostic evaluation

BMJ ◽  
2021 ◽  
pp. n214
Author(s):  
Weedon MN ◽  
Jackson L ◽  
Harrison JW ◽  
Ruth KS ◽  
Tyrrell J ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Predictive Value ◽  
Population Based ◽  
Genome Project ◽  
Personal Genome ◽  
Uk Biobank ◽  
Sequencing Data ◽  
Snp Chip ◽  
Pathogenic Variants ◽  
The Uk

Abstract Objective To determine whether the sensitivity and specificity of SNP chips are adequate for detecting rare pathogenic variants in a clinically unselected population. Design Retrospective, population based diagnostic evaluation. Participants 49 908 people recruited to the UK Biobank with SNP chip and next generation sequencing data, and an additional 21 people who purchased consumer genetic tests and shared their data online via the Personal Genome Project. Main outcome measures Genotyping (that is, identification of the correct DNA base at a specific genomic location) using SNP chips versus sequencing, with results split by frequency of that genotype in the population. Rare pathogenic variants in the BRCA1 and BRCA2 genes were selected as an exemplar for detailed analysis of clinically actionable variants in the UK Biobank, and BRCA related cancers (breast, ovarian, prostate, and pancreatic) were assessed in participants through use of cancer registry data. Results Overall, genotyping using SNP chips performed well compared with sequencing; sensitivity, specificity, positive predictive value, and negative predictive value were all above 99% for 108 574 common variants directly genotyped on the SNP chips and sequenced in the UK Biobank. However, the likelihood of a true positive result decreased dramatically with decreasing variant frequency; for variants that are very rare in the population, with a frequency below 0.001% in UK Biobank, the positive predictive value was very low and only 16% of 4757 heterozygous genotypes from the SNP chips were confirmed with sequencing data. Results were similar for SNP chip data from the Personal Genome Project, and 20/21 individuals analysed had at least one false positive rare pathogenic variant that had been incorrectly genotyped. For pathogenic variants in the BRCA1 and BRCA2 genes, which are individually very rare, the overall performance metrics for the SNP chips versus sequencing in the UK Biobank were: sensitivity 34.6%, specificity 98.3%, positive predictive value 4.2%, and negative predictive value 99.9%. Rates of BRCA related cancers in UK Biobank participants with a positive SNP chip result were similar to those for age matched controls (odds ratio 1.31, 95% confidence interval 0.99 to 1.71) because the vast majority of variants were false positives, whereas sequence positive participants had a significantly increased risk (odds ratio 4.05, 2.72 to 6.03). Conclusions SNP chips are extremely unreliable for genotyping very rare pathogenic variants and should not be used to guide health decisions without validation.

scholarly journals 3124 Early Electrographic Seizure Detection by Neuro ICU Nurses via Bedside Real-Time Quantitative EEG

2019 ◽  
Vol 3 (s1) ◽  
pp. 38-38
Author(s):  
Safa Kaleem ◽  
Christa B. Swisher
Keyword(s):  
Positive Predictive Value ◽  
Real Time ◽  
Predictive Value ◽  
Quantitative Eeg ◽  
University Hospital ◽  
Duke University ◽  
Study Population ◽  
Time To Detection ◽  
Sensitivity Specificity ◽  
Improve Patient

OBJECTIVES/SPECIFIC AIMS: 1. Determine positive predictive value, negative predictive value, sensitivity, and specificity of Neuro ICU nurse interpretation of real-time bedside qEEG. 2. Determine difference in time to detection of first seizure between Neuro ICU nurse qEEG interpretation and EEG fellow reads of cEEG. 3. Determine what qualities of seizures make detection by neuro ICU nurses more or less likely – e.g. duration of seizures, type of seizures, spatial extent of seizures. METHODS/STUDY POPULATION: Recruit neuro ICU nurses taking care of 150 patients admitted to the Neuro ICU at Duke University Hospital who are initiated on cEEG monitoring. Nurses will be consented for their participation in the study. Neuro ICU nurses will evaluate the qEE RESULTS/ANTICIPATED RESULTS: From literature estimates of a 20% seizure prevalence in critical care settings, we hope to have 30 patients with seizures and 120 without. Based on prior study in the Duke Neuro ICU, we hypothesize that Neuro ICU nurses will have sensitivity and DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first prospective study of neuro ICU nurse interpretation of real-time bedside qEEG in patients with unknown NCSE/NCS presence. If nurse sensitivity, specificity, and positive predictive value are clinically useful, which we deem would be so at a sensitivity of 70% or greater, with acceptable false alarm rate, nurse readings of qEEG could significantly decrease the time to treatment of seizures in the Neuro ICU patient population, and perhaps could improve patient outcomes.

scholarly journals Investigating the impact of disease and health record duration on the eMERGE algorithm for rheumatoid arthritis

2020 ◽  
Vol 27 (4) ◽  
pp. 601-605
Author(s):  
Vanessa L Kronzer ◽  
Liwei Wang ◽  
Hongfang Liu ◽  
John M Davis ◽  
Jeffrey A Sparks ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Index Date ◽  
Model Performance ◽  
Area Under The Curve ◽  
Population Based ◽  
Health Record ◽  
The Impact

Abstract Objective The study sought to determine the dependence of the Electronic Medical Records and Genomics (eMERGE) rheumatoid arthritis (RA) algorithm on both RA and electronic health record (EHR) duration. Materials and Methods Using a population-based cohort from the Mayo Clinic Biobank, we identified 497 patients with at least 1 RA diagnosis code. RA case status was manually determined using validated criteria for RA. RA duration was defined as time from first RA code to the index date of biobank enrollment. To simulate EHR duration, various years of EHR lookback were applied, starting at the index date and going backward. Model performance was determined by sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve (AUC). Results The eMERGE algorithm performed well in this cohort, with overall sensitivity 53%, specificity 99%, positive predictive value 97%, negative predictive value 74%, and AUC 76%. Among patients with RA duration <2 years, sensitivity and AUC were only 9% and 54%, respectively, but increased to 71% and 85% among patients with RA duration >10 years. Longer EHR lookback also improved model performance up to a threshold of 10 years, in which sensitivity reached 52% and AUC 75%. However, optimal EHR lookback varied by RA duration; an EHR lookback of 3 years was best able to identify recently diagnosed RA cases. Conclusions eMERGE algorithm performance improves with longer RA duration as well as EHR duration up to 10 years, though shorter EHR lookback can improve identification of recently diagnosed RA cases.

scholarly journals Impact of COVID-19 pre-test probability on positive predictive value of high cycle threshold SARS-CoV-2 real-time reverse transcription PCR test results

2021 ◽  
pp. 1-18
Author(s):  
Jonathan B. Gubbay ◽  
Heather Rilkoff ◽  
Heather L. Kristjanson ◽  
Jessica D. Forbes ◽  
Michelle Murti ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Real Time ◽  
Reverse Transcription ◽  
Predictive Value ◽  
Large Scale ◽  
Rdrp Gene ◽  
Nucleic Acid Detection ◽  
Rt Pcr ◽  
Pcr Assay ◽  
Test Probability

Abstract Objectives Performance characteristics of SARS-CoV-2 nucleic acid detection assays are understudied within contexts of low pre-test probability, including screening asymptomatic persons without epidemiological links to confirmed cases, or asymptomatic surveillance testing. SARS-CoV-2 detection without symptoms may represent presymptomatic or asymptomatic infection, resolved infection with persistent RNA shedding, or a false positive test. This study assessed positive predictive value of SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) assays by retesting positive specimens from five pre-test probability groups ranging from high to low with an alternate assay. Methods A total of 122 rRT-PCR positive specimens collected from unique patients between March and July 2020 were retested using a laboratory-developed nested RT-PCR assay targeting the RNA-dependent RNA polymerase (RdRp) gene followed by Sanger sequencing. Results Significantly fewer (15.6%) positive results in the lowest pre-test probability group (facilities with institution-wide screening having ≤ 3 positive asymptomatic cases) were reproduced with the nested RdRp gene RT-PCR assay than in each of the four groups with higher pre-test probability (individual group range 50·0% to 85·0%). Conclusions Large-scale SARS-CoV-2 screening testing initiatives among low pre-test probability populations should be evaluated thoroughly prior to implementation given the risk of false positives and consequent potential for harm at the individual and population level.

scholarly journals Validation of Diagnosis and Procedure Codes for Revascularization for Peripheral Artery Disease in Ontario Administrative Databases

2021 ◽  
Vol 44 (2) ◽  
pp. E36-43
Author(s):  
Jean Jacob-Brassard ◽  
Mohammed Al-Omran ◽  
Thérèse A. Stukel ◽  
Muhammad Mamdani ◽  
Douglas S. Lee ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Peripheral Artery Disease ◽  
Predictive Value ◽  
Population Based ◽  
Administrative Databases ◽  
Peripheral Artery ◽  
Predictive Values ◽  
Diagnosis Codes ◽  
Artery Disease ◽  
Procedure Codes

Purpose: To estimate the positive predictive value of diagnosis and procedure codes for open and endovascular revascularization for peripheral artery disease (PAD) in Ontario administrative databases. Methods: We conducted a retrospective validation study using population-based Ontario administrative databases (2005-2019) to identify a random sample of 600 patients who underwent revascularization for PAD at two academic centres, based on ICD-10 diagnosis codes and Canada Classification of Health Intervention procedure codes. Administrative data coding was compared to the gold standard diagnosis (PAD vs. non-PAD) and revascularization approach (open vs. endovascular) extracted through blinded hospital chart re-abstraction. Positive predictive values and 95% confidence intervals were calculated. Combinations of procedure codes with or without supplemental physician claims codes were evaluated to optimize the positive predictive value. Results: The overall positive predictive value of PAD diagnosis codes was 87.5% (84.6%-90.0%). The overall positive predictive value of revascularization procedure codes was 94.3% (92.2%-96.0%), which improved through supplementation with physician fee claim codes to 98.1% (96.6%-99.0%). Algorithms to identify individuals revascularized for PAD had combined positive predictive values ranging from 82.8% (79.6%-85.8%) to 95.7% (93.5%-97.3%). Conclusion: Diagnosis and procedure codes with or without physician claims codes allow for accurate identifi-cation of individuals revascularized for PAD in Ontario administrative databases.

scholarly journals Gold Standard Evaluation of an Automatic HAIs Surveillance System

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Beatriz Villamarín-Bello ◽  
Berta Uriel-Latorre ◽  
Florentino Fdez-Riverola ◽  
María Sande-Meijide ◽  
Daniel Glez-Peña
Keyword(s):  
Positive Predictive Value ◽  
Predictive Value ◽  
Gold Standard ◽  
Infection Type ◽  
University Hospital ◽  
Kappa Index ◽  
Best Value ◽  
Health Event ◽  
High Level ◽  
Hospital Acquired

Hospital-acquired Infections (HAIs) surveillance, defined as the systematic collection of data related to a certain health event, is considered an essential dimension for a prevention HAI program to be effective. In recent years, new automated HAI surveillance methods have emerged with the wide adoption of electronic health records (EHR). Here we present the validation results against the gold standard of HAIs diagnosis of the InNoCBR system deployed in the Ourense University Hospital Complex (Spain). Acting as a totally autonomous system, InNoCBR achieves a HAI sensitivity of 70.83% and a specificity of 97.76%, with a positive predictive value of 77.24%. The kappa index for infection type classification is 0.67. Sensitivity varies depending on infection type, where bloodstream infection attains the best value (93.33%), whereas the respiratory infection could be improved the most (53.33%). Working as a semi-automatic system, InNoCBR reaches a high level of sensitivity (81.73%), specificity (99.47%), and a meritorious positive predictive value (94.33%).

Treatment of therapy-refractive ulcera cruris of various origins with autologous keratinocytes in fibrin sealant

VASA ◽  
2005 ◽  
Vol 34 (1) ◽  
pp. 25-29 ◽  
Author(s):  
Johnsen ◽  
Ermuth ◽  
Tanczos ◽  
Bannasch ◽  
Horch ◽  
...  
Keyword(s):  
Observational Study ◽  
Fibrin Sealant ◽  
Chronic Wounds ◽  
Leg Ulcers ◽  
Impaired Wound Healing ◽  
Skin Excision ◽  
The Mean ◽  
High Degree ◽  
Chronic Leg Ulcers ◽  
Suspended Cells

Background: Evaluation of the effects of cultivated, subconfluent, autologous keratinocytes in fibrin sealant (BioSeed®-S) on the healing of therapy-refractive chronic wounds. Patients and methods: Open observational study in 60 patients with chronic leg ulcers and impaired wound healing of various origins. After whole-skin excision and cultivation of the autologous keratinocytes, the suspended cells were applied to the preconditioned wound in fibrin sealant. Wound epithelization and wound size were recorded at defined times. Results: Fifty-two of the 60 participating patients could be evaluated. After 6 weeks, 29 ulcers (55.8%) were healed. The mean epithelization increased between the 8th and 42nd postoperative day from 23% to 62.5%. In 50.0% of the patients, global assessment of the wound showed a high degree of epithelization or healing after 42 days. In 32.6 % of treated patients, improvement was observed, while no healing tendency was to be found in 17.4%. Conclusion: The present observational study indicates that the transplantation of autologous keratinocytes suspended in fibrin sealant could be of advantage in the treatment of refractive leg ulcers.

ROLE OF MAMMOGRAPHY AND CORE BIOPSY IN THE DIAGNOSIS OF BREAST TUMOR

2017 ◽  
pp. 69-72
Author(s):  
Trong Hung Phan ◽  
Cong Thuan Dang ◽  
Thanh Thao Nguyen
Keyword(s):  
Breast Cancer ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Breast Tumor ◽  
Core Biopsy ◽  
Breast Tumors ◽  
Breast Disease ◽  
University Hospital ◽  
Sensitivity Specificity

Introduction: Breast tumor is a popular disease. Breast cancer is the most common cancer in women. Mammography is the chosen screening test and ultrasound-guided core-needle biopsy provides (US-CNB) the pathologic result for treatment. Objective: To study the role of mammography and core biopsy in diagnosis of breast tumors. Materials and methodology: Prospective and retrospective study of 33 breast tumors examined mammograms at Hue University Hospital and Hue Central Hospital from 7/2014 to 4/2017. Results: Mean age of breast cancer: 52 years old, of benign breast disease: 53 years old. 86% of all cases admitted to hospital due to self-detecting breast tumor. Locations: 0-3h 33.3%, 9-12h 27.2%. Sensitivity, specificity and accuracy of mammography were 76.9%, 28.6% and 66.7% respectively. Sensitivity, specificity, positive predictive value, negative predictive value, accuracy value of US-CNB were 95.2%, 85.6%, 95.2%, 85.6% and 92.9%, respectively. The value of combined with mammograms and US-CNB has improved the specificity and positive predictive value to 100%, accuracy value to 95.2%. Moreover, this combination discovered 7.1% breast cancer more. Conclusion: US-CNB is a safe and less traumatic diagnostic tool with high pathologic efficiency. Combining mammography and US-CNB increases the diagnostic value. Key words: Breast tumor, breast cancer, mammograms

Basic variables at different positivity thresholds of a quantitative immunochemical test for faecal occult blood

2002 ◽  
Vol 9 (3) ◽  
pp. 99-103 ◽  
Author(s):  
G. Castiglione ◽  
G. Grazzini ◽  
G. Miccinesi ◽  
T. Rubeca ◽  
C. Sani ◽  
...  
Keyword(s):  
High Risk ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Occult Blood ◽  
Recall Rate ◽  
Population Based ◽  
Detection Rates ◽  
Predictive Values ◽  
Faecal Occult Blood ◽  
Faecal Occult

OBJECTIVES: Screening by faecal occult blood testing (FOBT) is effective in decreasing mortality and incidence of colorectal cancer (CRC). Immunochemical tests have proved to be more cost effective than guaiac FOBTs. The latex agglutination test (LAT) has the advantage of being a fully automated, quantitative test. The aim of this study is to interpret the overall experience with LAT according to different positivity thresholds. SETTING: A population based screening programme is currently running involving subjects aged 50–70, invited every 2 years to have an FOBT. LAT is the standard screening test and has a positivity threshold for further diagnostic tests of 100 ng haemoglobin/ml of sample solution. METHODS: Positivity rates, detection rates for CRC high risk adenomas, and positive predictive values for CRC, high risk adenomas, and low risk adenomas were calculated for several positivity thresholds. RESULTS: 19 132 attendances at screening were recorded (11 774 at first screening, 7358 at subsequent screenings). Progressively increasing the positivity threshold from 100 to 200 ng/ml showed (a) a decrease in positivity rate; (b) a decrease in detection rates for CRC or high risk adenomas; (c) an increase in positive predictive values for cancer; (d) an increase in positive predictive value for high risk adenomas. CONCLUSIONS: Increasing the positivity threshold of the LAT reduces recall rate and improves positive predictive value for cancer or high risk adenomas but substantially decreases the detection rate of CRC and high risk adenomas. For this reason increasing the positivity cut off for LATs is not advisable. On the other hand decreasing the positivity threshold would increase recall rate and sensitivity of screening. Careful evaluation of sensitivity of the quantitative results of the LAT for interval cancers is needed to definitively assess the optimal positivity threshold for LATs in population based screening programmes.

Efficacy and Safety of a Hyaluronic Acid-Containing Gauze Pad in the Treatment of Chronic Venous or Mixed-Origin Leg Ulcers: A Prospective, Multicenter, Randomized Controlled Trial

2021 ◽  
Vol 66 (6) ◽  
pp. 147-157
Author(s):  
Jacek Mikosinski ◽  
Anna Di Landro ◽  
Krzysztofa Łuczak-Szymerska ◽  
Emilie Soriano ◽  
Carol Caverzasio ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Chronic Wounds ◽  
Treatment Time ◽  
Complete Healing ◽  
Leg Ulcers ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Multicenter Randomized Controlled Trial ◽  
Mixed Origin ◽  
Chronic Leg Ulcers

Introduction. Hyaluronic acid (HA)-containing formulations routinely are utilized along with standard therapy to promote faster healing of chronic wounds; evidence to guide clinical decisions on the use of topical HA in the healing of vascular leg ulcers is limited. Objective. This study compared the efficacy and safety of an HA-impregnated gauze pad with an identical gauze pad without HA in the treatment of chronic leg ulcers of vascular origin. Materials and Methods. A prospective, multicenter, multinational, parallel-group, randomized, double-blind, clinical study was conducted between June 13, 2017, and December 31, 2018. Adults with 1 or more chronic leg ulcers of venous or mixed origin between 2 months and 4 years’ duration were eligible to participate. Participants were randomized to treatment consisting of standard care (ie, ulcer cleansing, debridement/anesthesia as necessary, and optimized compression) and either application of a gauze pad containing 0.05% HA or a neutral comparator once daily for a maximum of 20 weeks. The primary efficacy endpoint was complete ulcer healing (100% reepithelialization of the wound area centrally assessed by 1 independent and experienced assessor blinded with respect to the treatment applied, as shown on digital photographs taken under standardized conditions at or before 20 weeks and confirmed 3 weeks later). Secondary efficacy endpoints included the percentage of completely healed target ulcers, residual area of target ulcer relative to baseline, the condition of the periulcerous skin, the total amount of analgesics used, the incidence of infection at the ulcer site of the target ulcer, patient adherence to treatment, time to achieve complete healing as centrally assessed, and pain intensity as measured by a visual analog scale. Results. Among the 168 participants (82 in the HA gauze pad group and 86 in the neutral gauze pad group), 33 (39.8%) in the HA group experienced complete healing of the target ulcer, which was significantly higher than the neutral comparator group (15, 18.5%; P = .002). Results in the full analysis and per-protocol sets were consistent with the primary results; no significant difference was noted in outcomes when participants’ wounds were stratified according to baseline ulcer size. Conclusions. HA delivered in a gauze pad formulation could be a beneficial treatment for chronic leg ulcers of venous or mixed origin.

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