Disseminated histoplasmosis and AIDS: clinical aspects and diagnostic methods for early detection.

PubMed

Corti, M E; Cendoya, C A; Soto, I; Esquivel, P; Trione, N; Villafañe, M F; Corbera, K M; Helou, S; Negroni, R

2000-03-01

Disseminated histoplasmosis in AIDS patients is the focus of this paper. Cutaneous lesions are reported as a frequent clinical sign. Bone marrow aspiration and biopsy, blood cultures (lysis-centrifugation technique), bronchoalveolar lavage, and skin lesion scrapings are the most effective diagnostic methods. The identification of a specific antigen in blood and urine may be a rapid means of evaluation and follow-up of patients with this disease.

Evaluating the accessibility and utility of HIV-related point-of-care diagnostics for maternal health in rural South Africa: a study protocol

PubMed Central

Mashamba-Thompson, T P; Drain, P K; Sartorius, B

2016-01-01

Introduction Poor healthcare access is a major barrier to receiving antenatal care and a cause of high maternal mortality in South Africa (SA). ‘Point-of-care’ (POC) diagnostics is a powerful emerging healthcare approach to improve healthcare access. This study focuses on evaluating the accessibility and utility of POC diagnostics for maternal health in rural SA primary healthcare (PHC) clinics in order to generate a model framework of implementation of POC diagnostics in rural South African clinics. Method and analyses We will use several research methods, including a systematic review, quasi-experiments, survey, key informant interviews and audits. We will conduct a systematic review and experimental study to determine the impact of POC diagnostics on maternal health. We will perform a cross-sectional case study of 100 randomly selected rural primary healthcare clinics in KwaZulu-Natal to measure the context and patterns of POC diagnostics access and usage by maternal health providers and patients. We will conduct interviews with relevant key stakeholders to determine the reasons for POC deficiencies regarding accessibility and utility of HIV-related POC diagnostics for maternal health. We will also conduct a vertical audit to investigate all the quality aspects of POC diagnostic services including diagnostic accuracy in a select number of clinics. On the basis of information gathered, we will propose a model framework for improved implementation of POC diagnostics in rural South African public healthcare clinics. Statistical (Stata-13) and thematic (NVIVO) data analysis will be used in this study. Ethics and dissemination The study protocol was approved by the Ethics Committee of the University of KwaZulu-Natal (BE 484/14) and the KwaZulu-Natal Department of Health based on the Helsinki Declaration (HRKM 40/15). Findings of this study will be disseminated electronically and in print. They will be presented to conferences related to HIV/AIDS, diagnostics, maternal health and strengthening of health systems. PMID:27354074

[Methods of statistical analysis in differential diagnostics of the degree of brain glioma anaplasia during preoperative stage].

PubMed

Glavatskiĭ, A Ia; Guzhovskaia, N V; Lysenko, S N; Kulik, A V

2005-12-01

The authors proposed a possible preoperative diagnostics of the degree of supratentorial brain gliom anaplasia using statistical analysis methods. It relies on a complex examination of 934 patients with I-IV degree anaplasias, which had been treated in the Institute of Neurosurgery from 1990 to 2004. The use of statistical analysis methods for differential diagnostics of the degree of brain gliom anaplasia may optimize a diagnostic algorithm, increase reliability of obtained data and in some cases avoid carrying out irrational operative intrusions. Clinically important signs for the use of statistical analysis methods directed to preoperative diagnostics of brain gliom anaplasia have been defined

Studies on the foundation and development of diagnostic ultrasound

PubMed Central

Wagai, Toshio

2007-01-01

In recent years, various types of diagnostic imaging methods, such as CT, MRI, PET and Ultrasound, have been developed rapidly and become indispensable as clinical diagnostic tools. Among these imaging modalities, CT, MRI and PET all apply electromagnetic waves like radiation rays. In contrast, an ultrasound imaging method uses a completely different mechanical pressure wave: “sound”. Ultrasound has various features, including inaudible sound at very high frequencies, which allows its use in medical diagnoses. That is, ultrasound techniques can be applied in transmission, reflection and Doppler methods. Moreover, the sharp directivity of an ultrasound beam can also improve image resolution. Another big advantage of diagnostic ultrasound is that it does not harm the human body or cause any pain to patients. Given these various advantages, diagnostic ultrasound has recently been widely used in diagnosing cancer and cardiovascular disease and scanning fetuses (Fig. 1) as well as routine clinical examinations in hospitals. In this paper, I outline my almost 50-year history of diagnostic ultrasound research, particularly that performed at the early stage from 1950–56. PMID:24367150

Improved diagnostic yield compared with targeted gene sequencing panels suggests a role for whole-genome sequencing as a first-tier genetic test

PubMed Central

Lionel, Anath C; Costain, Gregory; Monfared, Nasim; Walker, Susan; Reuter, Miriam S; Hosseini, S Mohsen; Thiruvahindrapuram, Bhooma; Merico, Daniele; Jobling, Rebekah; Nalpathamkalam, Thomas; Pellecchia, Giovanna; Sung, Wilson W L; Wang, Zhuozhi; Bikangaga, Peter; Boelman, Cyrus; Carter, Melissa T; Cordeiro, Dawn; Cytrynbaum, Cheryl; Dell, Sharon D; Dhir, Priya; Dowling, James J; Heon, Elise; Hewson, Stacy; Hiraki, Linda; Inbar-Feigenberg, Michal; Klatt, Regan; Kronick, Jonathan; Laxer, Ronald M; Licht, Christoph; MacDonald, Heather; Mercimek-Andrews, Saadet; Mendoza-Londono, Roberto; Piscione, Tino; Schneider, Rayfel; Schulze, Andreas; Silverman, Earl; Siriwardena, Komudi; Snead, O Carter; Sondheimer, Neal; Sutherland, Joanne; Vincent, Ajoy; Wasserman, Jonathan D; Weksberg, Rosanna; Shuman, Cheryl; Carew, Chris; Szego, Michael J; Hayeems, Robin Z; Basran, Raveen; Stavropoulos, Dimitri J; Ray, Peter N; Bowdin, Sarah; Meyn, M Stephen; Cohn, Ronald D; Scherer, Stephen W; Marshall, Christian R

2018-01-01

Purpose Genetic testing is an integral diagnostic component of pediatric medicine. Standard of care is often a time-consuming stepwise approach involving chromosomal microarray analysis and targeted gene sequencing panels, which can be costly and inconclusive. Whole-genome sequencing (WGS) provides a comprehensive testing platform that has the potential to streamline genetic assessments, but there are limited comparative data to guide its clinical use. Methods We prospectively recruited 103 patients from pediatric non-genetic subspecialty clinics, each with a clinical phenotype suggestive of an underlying genetic disorder, and compared the diagnostic yield and coverage of WGS with those of conventional genetic testing. Results WGS identified diagnostic variants in 41% of individuals, representing a significant increase over conventional testing results (24% P = 0.01). Genes clinically sequenced in the cohort (n = 1,226) were well covered by WGS, with a median exonic coverage of 40 × ±8 × (mean ±SD). All the molecular diagnoses made by conventional methods were captured by WGS. The 18 new diagnoses made with WGS included structural and non-exonic sequence variants not detectable with whole-exome sequencing, and confirmed recent disease associations with the genes PIGG, RNU4ATAC, TRIO, and UNC13A. Conclusion WGS as a primary clinical test provided a higher diagnostic yield than conventional genetic testing in a clinically heterogeneous cohort. PMID:28771251

Improved diagnostic yield compared with targeted gene sequencing panels suggests a role for whole-genome sequencing as a first-tier genetic test.

PubMed

Lionel, Anath C; Costain, Gregory; Monfared, Nasim; Walker, Susan; Reuter, Miriam S; Hosseini, S Mohsen; Thiruvahindrapuram, Bhooma; Merico, Daniele; Jobling, Rebekah; Nalpathamkalam, Thomas; Pellecchia, Giovanna; Sung, Wilson W L; Wang, Zhuozhi; Bikangaga, Peter; Boelman, Cyrus; Carter, Melissa T; Cordeiro, Dawn; Cytrynbaum, Cheryl; Dell, Sharon D; Dhir, Priya; Dowling, James J; Heon, Elise; Hewson, Stacy; Hiraki, Linda; Inbar-Feigenberg, Michal; Klatt, Regan; Kronick, Jonathan; Laxer, Ronald M; Licht, Christoph; MacDonald, Heather; Mercimek-Andrews, Saadet; Mendoza-Londono, Roberto; Piscione, Tino; Schneider, Rayfel; Schulze, Andreas; Silverman, Earl; Siriwardena, Komudi; Snead, O Carter; Sondheimer, Neal; Sutherland, Joanne; Vincent, Ajoy; Wasserman, Jonathan D; Weksberg, Rosanna; Shuman, Cheryl; Carew, Chris; Szego, Michael J; Hayeems, Robin Z; Basran, Raveen; Stavropoulos, Dimitri J; Ray, Peter N; Bowdin, Sarah; Meyn, M Stephen; Cohn, Ronald D; Scherer, Stephen W; Marshall, Christian R

2018-04-01

PurposeGenetic testing is an integral diagnostic component of pediatric medicine. Standard of care is often a time-consuming stepwise approach involving chromosomal microarray analysis and targeted gene sequencing panels, which can be costly and inconclusive. Whole-genome sequencing (WGS) provides a comprehensive testing platform that has the potential to streamline genetic assessments, but there are limited comparative data to guide its clinical use.MethodsWe prospectively recruited 103 patients from pediatric non-genetic subspecialty clinics, each with a clinical phenotype suggestive of an underlying genetic disorder, and compared the diagnostic yield and coverage of WGS with those of conventional genetic testing.ResultsWGS identified diagnostic variants in 41% of individuals, representing a significant increase over conventional testing results (24%; P = 0.01). Genes clinically sequenced in the cohort (n = 1,226) were well covered by WGS, with a median exonic coverage of 40 × ±8 × (mean ±SD). All the molecular diagnoses made by conventional methods were captured by WGS. The 18 new diagnoses made with WGS included structural and non-exonic sequence variants not detectable with whole-exome sequencing, and confirmed recent disease associations with the genes PIGG, RNU4ATAC, TRIO, and UNC13A.ConclusionWGS as a primary clinical test provided a higher diagnostic yield than conventional genetic testing in a clinically heterogeneous cohort.

The Health Technology Assessment of companion diagnostics: experience of NICE.

PubMed

Byron, Sarah K; Crabb, Nick; George, Elisabeth; Marlow, Mirella; Newland, Adrian

2014-03-15

Companion diagnostics are used to aid clinical decision making to identify patients who are most likely to respond to treatment. They are becoming increasingly important as more new pharmaceuticals receive licensed indications that require the use of a companion diagnostic to identify the appropriate patient subgroup for treatment. These pharmaceuticals have proven benefit in the treatment of some cancers and other diseases, and also have potential to precisely tailor treatments to the individual in the future. However, the increasing use of companion diagnostics could place a substantial burden on health system resources to provide potentially high volumes of testing. This situation, in part, has led policy makers and Health Technology Assessment (HTA) bodies to review the policies and methods used to make reimbursement decisions for pharmaceuticals requiring companion diagnostics. The assessment of a pharmaceutical alongside the companion diagnostic used in the clinical trials may be relatively straightforward, although there are a number of challenges associated with assessing pharmaceuticals where a range of alternative companion diagnostics are available for use in routine clinical practice. The UK HTA body, the National Institute for Health and Care Excellence (NICE), has developed policy for considering companion diagnostics using its Technology Appraisal and Diagnostics Assessment Programs. Some HTA bodies in other countries have also adapted their policies and methods to accommodate the assessment of companion diagnostics. Here, we provide insight into the HTA of companion diagnostics for reimbursement decisions and how the associated challenges are being addressed, in particular by NICE. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

The clinical performance evaluation of novel protein chips for eleven biomarkers detection and the diagnostic model study.

PubMed

Luo, Yuan; Zhu, Xu; Zhang, Pengjun; Shen, Qian; Wang, Zi; Wen, Xinyu; Wang, Ling; Gao, Jing; Dong, Jin; Yang, Caie; Wu, Tangming; Zhu, Zheng; Tian, Yaping

2015-01-01

We aimed to develop and validate two novel protein chips, which are based on microarray chemiluminescence immunoassay and can simultaneously detected 11 biomarkers, and then to evaluate their clinical diagnostic value by comparing with the traditional methods. Protein chips were evaluated for limit of detection, specificity, common interferences, linearity, precision and accuracy. 11 biomarkers were simultaneously detected by traditional methods and protein chips in 3683 samples, which included 1723 cancer patients, 1798 benign diseases patients and 162 healthy controls. After assay validation, protein chips demonstrated high sensitivity, high specificity, good linearity, low imprecision and were free of common interferences. Compared with the traditional methods, protein chips have good correlation in the detection of all the 13 kinds of biomarkers (r≥0.935, P<0.001). For specific cancer detection, there were no statistically significant differences between the traditional method and novel protein chips, except that male protein chip showed significantly better diagnostic value on NSE detection (P=0.004) but significantly worse value on pro-GRP detection (P=0.012), female chip showed significantly better diagnostic value on pro-GRP detection (P=0.005). Furthermore, both male and female multivariate diagnostic models had significantly better diagnostic value than single detection of PGI, PG II, pro-GRP, NSE and CA125 (P<0.05). In addition, male models had significantly better diagnostic value than single CA199 and free-PSA (P<0.05), while female models observed significantly better diagnostic value than single CA724 and β-HCG (P<0.05). For total disease or cancer detection, the AUC of multivariate logistic regression for the male and female disease detection was 0.981 (95% CI: 0.975-0.987) and 0.836 (95% CI: 0.798-0.874), respectively. While, that for total cancer detection was 0.691 (95% CI: 0.666-0.717) and 0.753 (95% CI: 0.731-0.775), respectively. The new designed protein chips are simple, multiplex and reliable clinical assays and the multi-parameter diagnostic models based on them could significantly improve their clinical performance.

The clinical performance evaluation of novel protein chips for eleven biomarkers detection and the diagnostic model study

PubMed Central

Luo, Yuan; Zhu, Xu; Zhang, Pengjun; Shen, Qian; Wang, Zi; Wen, Xinyu; Wang, Ling; Gao, Jing; Dong, Jin; Yang, Caie; Wu, Tangming; Zhu, Zheng; Tian, Yaping

2015-01-01

We aimed to develop and validate two novel protein chips, which are based on microarray chemiluminescence immunoassay and can simultaneously detected 11 biomarkers, and then to evaluate their clinical diagnostic value by comparing with the traditional methods. Protein chips were evaluated for limit of detection, specificity, common interferences, linearity, precision and accuracy. 11 biomarkers were simultaneously detected by traditional methods and protein chips in 3683 samples, which included 1723 cancer patients, 1798 benign diseases patients and 162 healthy controls. After assay validation, protein chips demonstrated high sensitivity, high specificity, good linearity, low imprecision and were free of common interferences. Compared with the traditional methods, protein chips have good correlation in the detection of all the 13 kinds of biomarkers (r≥0.935, P<0.001). For specific cancer detection, there were no statistically significant differences between the traditional method and novel protein chips, except that male protein chip showed significantly better diagnostic value on NSE detection (P=0.004) but significantly worse value on pro-GRP detection (P=0.012), female chip showed significantly better diagnostic value on pro-GRP detection (P=0.005). Furthermore, both male and female multivariate diagnostic models had significantly better diagnostic value than single detection of PGI, PG II, pro-GRP, NSE and CA125 (P<0.05). In addition, male models had significantly better diagnostic value than single CA199 and free-PSA (P<0.05), while female models observed significantly better diagnostic value than single CA724 and β-HCG (P<0.05). For total disease or cancer detection, the AUC of multivariate logistic regression for the male and female disease detection was 0.981 (95% CI: 0.975-0.987) and 0.836 (95% CI: 0.798-0.874), respectively. While, that for total cancer detection was 0.691 (95% CI: 0.666-0.717) and 0.753 (95% CI: 0.731-0.775), respectively. The new designed protein chips are simple, multiplex and reliable clinical assays and the multi-parameter diagnostic models based on them could significantly improve their clinical performance. PMID:26884957

Syndrome diagnosis: human intuition or machine intelligence?

PubMed

Braaten, Oivind; Friestad, Johannes

2008-01-01

The aim of this study was to investigate whether artificial intelligence methods can represent objective methods that are essential in syndrome diagnosis. Most syndromes have no external criterion standard of diagnosis. The predictive value of a clinical sign used in diagnosis is dependent on the prior probability of the syndrome diagnosis. Clinicians often misjudge the probabilities involved. Syndromology needs objective methods to ensure diagnostic consistency, and take prior probabilities into account. We applied two basic artificial intelligence methods to a database of machine-generated patients - a 'vector method' and a set method. As reference methods we ran an ID3 algorithm, a cluster analysis and a naive Bayes' calculation on the same patient series. The overall diagnostic error rate for the the vector algorithm was 0.93%, and for the ID3 0.97%. For the clinical signs found by the set method, the predictive values varied between 0.71 and 1.0. The artificial intelligence methods that we used, proved simple, robust and powerful, and represent objective diagnostic methods.

Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders

PubMed Central

Mashamba-Thompson, Tivani P.; Jama, Ngcwalisa A.; Sartorius, Benn; Drain, Paul K.; Thompson, Rowan M.

2017-01-01

Introduction: Key stakeholders’ involvement is crucial to the sustainability of quality point-of-care (POC) diagnostics services in low-and-middle income countries. The aim of this study was to explore key stakeholder perceptions on the implementation of POC diagnostics in rural primary healthcare (PHC) clinics in South Africa. Method: We conducted a qualitative study encompassing in-depth interviews with multiple key stakeholders of POC diagnostic services for rural and resource-limited PHC clinics. Interviews were digitally recorded and transcribed verbatim prior to thematic content analysis. Thematic content analysis was conducted using themes guided by the World Health Organisation (WHO) quality-ASSURED (Affordable, Sensitive, Specific, User friendly, Rapid and to enable treatment at first visit and Robust, Equipment free and Delivered to those who need it) criteria for POC diagnostic services in resource-limited settings. Results: 11 key stakeholders participated in the study. All stakeholders perceived the main advantage of POC diagnostics as enabling access to healthcare for rural patients. Stakeholders perceived the current POC diagnostic services to have an ability to meet patients’ needs, but recommended further improvement of the following areas: research on cost-effectiveness; improved quality management systems; development of affordable POC diagnostic and clinic-based monitoring and evaluation. Conclusions: Key stakeholders of POC diagnostics in rural PHC clinics in South Africa highlighted the need to assess affordability and ensure quality assurance of current services before adopting new POC diagnostics and scaling up current POC diagnostics. PMID:28075337

Increasing role of arthropod bites in tularaemia transmission in Poland - case reports and diagnostic methods.

PubMed

Formińska, Kamila; Zasada, Aleksandra A; Rastawicki, Waldemar; Śmietańska, Karolina; Bander, Dorota; Wawrzynowicz-Syczewska, Marta; Yanushevych, Mariya; Niścigórska-Olsen, Jolanta; Wawszczak, Marek

2015-01-01

The study describes four cases of tularaemia - one developed after contact with rabbits and three developed after an arthropod bite. Due to non-specific clinical symptoms, accurate diagnosis of tularaemia may be difficult. The increasing contribution of the arthropod vectors in the transmission of the disease indicates that special effort should be made to apply sensitive and specific diagnostic methods for tularaemia, and to remind health-care workers about this route of Francisella tularensis infections. The advantages and disadvantages of various diagnostic methods - molecular, serological and microbiological culture - are discussed. The PCR as a rapid and proper diagnostic method for ulceroglandular tularaemia is presented.

Syndrome Diagnosis: Human Intuition or Machine Intelligence?

PubMed Central

Braaten, Øivind; Friestad, Johannes

2008-01-01

The aim of this study was to investigate whether artificial intelligence methods can represent objective methods that are essential in syndrome diagnosis. Most syndromes have no external criterion standard of diagnosis. The predictive value of a clinical sign used in diagnosis is dependent on the prior probability of the syndrome diagnosis. Clinicians often misjudge the probabilities involved. Syndromology needs objective methods to ensure diagnostic consistency, and take prior probabilities into account. We applied two basic artificial intelligence methods to a database of machine-generated patients - a ‘vector method’ and a set method. As reference methods we ran an ID3 algorithm, a cluster analysis and a naive Bayes’ calculation on the same patient series. The overall diagnostic error rate for the the vector algorithm was 0.93%, and for the ID3 0.97%. For the clinical signs found by the set method, the predictive values varied between 0.71 and 1.0. The artificial intelligence methods that we used, proved simple, robust and powerful, and represent objective diagnostic methods. PMID:19415142

Isothermal multiple displacement amplification: a methodical approach enhancing molecular routine diagnostics of microcarcinomas and small biopsies.

PubMed

Mairinger, Fabian D; Walter, Robert Fh; Vollbrecht, Claudia; Hager, Thomas; Worm, Karl; Ting, Saskia; Wohlschläger, Jeremias; Zarogoulidis, Paul; Zarogoulidis, Konstantinos; Schmid, Kurt W

2014-01-01

Isothermal multiple displacement amplification (IMDA) can be a powerful tool in molecular routine diagnostics for homogeneous and sequence-independent whole-genome amplification of notably small tumor samples, eg, microcarcinomas and biopsies containing a small amount of tumor. Currently, this method is not well established in pathology laboratories. We designed a study to confirm the feasibility and convenience of this method for routine diagnostics with formalin-fixed, paraffin-embedded samples prepared by laser-capture microdissection. A total of 250 μg DNA (concentration 5 μg/μL) was generated by amplification over a period of 8 hours with a material input of approximately 25 cells, approximately equivalent to 175 pg of genomic DNA. In the generated DNA, a representation of all chromosomes could be shown and the presence of elected genes relevant for diagnosis in clinical samples could be proven. Mutational analysis of clinical samples could be performed without any difficulty and showed concordance with earlier diagnostic findings. We established the feasibility and convenience of IMDA for routine diagnostics. We also showed that small amounts of DNA, which were not analyzable with current molecular methods, could be sufficient for a wide field of applications in molecular routine diagnostics when they are preamplified with IMDA.

Examining Curricular Integration Strategies To Optimize Learning Of The Anatomical Sciences

NASA Astrophysics Data System (ADS)

Lisk, Kristina Adriana Ayako

Background: Integration of basic and clinical science knowledge is essential to clinical practice. Although the importance of these two knowledge domains is well-recognized, successfully supporting the development of learners' integrated basic and clinical science knowledge, remains an educational challenge. In this dissertation, I examine curricular integration strategies to optimize learning of the anatomical sciences. Objectives: The studies were designed to achieve the following research aims: 1) to objectively identify clinically relevant content for an integrated musculoskeletal anatomy curriculum; 2) to examine the value of integrated anatomy and clinical science instruction compared to clinical science instruction alone on novices' diagnostic accuracy and diagnostic reasoning process; 3) to compare the effect of integrating and segregating anatomy and clinical science instruction along with a learning strategy (self-explanation) on novices' diagnostic accuracy. Methods: A modified Delphi was used to objectively select clinically relevant content for an integrated musculoskeletal anatomy curriculum. Two experimental studies were created to compare different instructional strategies to optimize learning of the curricular content. In both of these studies, novice learners were taught the clinical features of musculoskeletal pathologies using different learning approaches. Diagnostic performance was measured immediately after instruction and one-week later. Results: The results show that the Delphi method is an effective strategy to select clinically relevant content for integrated anatomy curricula. The findings also demonstrate that novices who were explicitly taught the clinical features of musculoskeletal diseases using causal basic science descriptions had superior diagnostic accuracy and a better understanding of the relative importance of key clinical features for disease categories. Conclusions: This research demonstrates how integration strategies can be applied at multiple levels of the curriculum. Further, this work shows the value of cognitive integration of anatomy and clinical science and it emphasizes the importance of purposefully linking the anatomical and clinical sciences in day-to-day teaching.

Systematic reviews of diagnostic tests in endocrinology: an audit of methods, reporting, and performance.

PubMed

Spencer-Bonilla, Gabriela; Singh Ospina, Naykky; Rodriguez-Gutierrez, Rene; Brito, Juan P; Iñiguez-Ariza, Nicole; Tamhane, Shrikant; Erwin, Patricia J; Murad, M Hassan; Montori, Victor M

2017-07-01

Systematic reviews provide clinicians and policymakers estimates of diagnostic test accuracy and their usefulness in clinical practice. We identified all available systematic reviews of diagnosis in endocrinology, summarized the diagnostic accuracy of the tests included, and assessed the credibility and clinical usefulness of the methods and reporting. We searched Ovid MEDLINE, EMBASE, and Cochrane CENTRAL from inception to December 2015 for systematic reviews and meta-analyses reporting accuracy measures of diagnostic tests in endocrinology. Experienced reviewers independently screened for eligible studies and collected data. We summarized the results, methods, and reporting of the reviews. We performed subgroup analyses to categorize diagnostic tests as most useful based on their accuracy. We identified 84 systematic reviews; half of the tests included were classified as helpful when positive, one-fourth as helpful when negative. Most authors adequately reported how studies were identified and selected and how their trustworthiness (risk of bias) was judged. Only one in three reviews, however, reported an overall judgment about trustworthiness and one in five reported using adequate meta-analytic methods. One in four reported contacting authors for further information and about half included only patients with diagnostic uncertainty. Up to half of the diagnostic endocrine tests in which the likelihood ratio was calculated or provided are likely to be helpful in practice when positive as are one-quarter when negative. Most diagnostic systematic reviews in endocrine lack methodological rigor, protection against bias, and offer limited credibility. Substantial efforts, therefore, seem necessary to improve the quality of diagnostic systematic reviews in endocrinology.

Diagnosis of Upper-Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of APTA

PubMed Central

Levenhagen, Kimberly; Davies, Claire; Perdomo, Marisa; Ryans, Kathryn

2017-01-01

Introduction: The Oncology Section of APTA developed a clinical practice guideline to aid the clinician in diagnosing secondary upper-quadrant cancer-related lymphedema. Methods: Following a systematic review of published studies and a structured appraisal process, recommendations were written to guide the physical therapist and other health care clinicians in their diagnostic process. Overall, clinical practice recommendations were formulated on the basis of the evidence for each diagnostic method and were assigned a grade based on the strength of the evidence for different patient presentations and clinical utility. Recommendations: In an effort to make these clinically applicable, recommendations were based on the characteristics as to the location and stage of a patient's upper-quadrant lymphedema. PMID:28748128

Diagnostic Accuracy Assessment of Sensititre and Agar Disk Diffusion for Determining Antimicrobial Resistance Profiles of Bovine Clinical Mastitis Pathogens▿

PubMed Central

Saini, V.; Riekerink, R. G. M. Olde; McClure, J. T.; Barkema, H. W.

2011-01-01

Determining the accuracy and precision of a measuring instrument is pertinent in antimicrobial susceptibility testing. This study was conducted to predict the diagnostic accuracy of the Sensititre MIC mastitis panel (Sensititre) and agar disk diffusion (ADD) method with reference to the manual broth microdilution test method for antimicrobial resistance profiling of Escherichia coli (n = 156), Staphylococcus aureus (n = 154), streptococcal (n = 116), and enterococcal (n = 31) bovine clinical mastitis isolates. The activities of ampicillin, ceftiofur, cephalothin, erythromycin, oxacillin, penicillin, the penicillin-novobiocin combination, pirlimycin, and tetracycline were tested against the isolates. Diagnostic accuracy was determined by estimating the area under the receiver operating characteristic curve; intertest essential and categorical agreements were determined as well. Sensititre and the ADD method demonstrated moderate to highly accurate (71 to 99%) and moderate to perfect (71 to 100%) predictive accuracies for 74 and 76% of the isolate-antimicrobial MIC combinations, respectively. However, the diagnostic accuracy was low for S. aureus-ceftiofur/oxacillin combinations and other streptococcus-ampicillin combinations by either testing method. Essential agreement between Sensititre automatic MIC readings and MIC readings obtained by the broth microdilution test method was 87%. Essential agreement between Sensititre automatic and manual MIC reading methods was 97%. Furthermore, the ADD test method and Sensititre MIC method exhibited 92 and 91% categorical agreement (sensitive, intermediate, resistant) of results, respectively, compared with the reference method. However, both methods demonstrated lower agreement for E. coli-ampicillin/cephalothin combinations than for Gram-positive isolates. In conclusion, the Sensititre and ADD methods had moderate to high diagnostic accuracy and very good essential and categorical agreement for most udder pathogen-antimicrobial combinations and can be readily employed in veterinary diagnostic laboratories. PMID:21270215

Conventional and molecular diagnostic strategies for prosthetic joint infections.

PubMed

Esteban, Jaime; Sorlí, Luisa; Alentorn-Geli, Eduard; Puig, Lluís; Horcajada, Juan P

2014-01-01

An accurate diagnosis of prosthetic joint infection (PJI) is the mainstay for an optimized clinical management. This review analyzes different diagnostic strategies of PJI, with special emphasis on molecular diagnostic tools and their current and future applications. Until now, the culture of periprosthetic tissues has been considered the gold standard for the diagnosis of PJI. However, sonication of the implant increases the sensitivity of those cultures and is being increasingly adopted by many centers. Molecular diagnostic methods compared with intraoperative tissue culture, especially if combined with sonication, have a higher sensitivity, a faster turnaround time and are not influenced by previous antimicrobial therapy. However, they still lack a system for detection of antimicrobial susceptibility, which is crucial for an optimized and less toxic therapy of PJI. More studies are needed to assess the clinical value of these methods and their cost-effectiveness.

Chagas disease diagnostic applications: present knowledge and future steps

PubMed Central

Balouz, Virginia; Agüero, Fernán; Buscaglia, Carlos A.

2017-01-01

Chagas disease, caused by the protozoan Trypanosoma cruzi, is a life-long and debilitating illness of major significance throughout Latin America, and an emergent threat to global public health. Being a neglected disease, the vast majority of Chagasic patients have limited access to proper diagnosis and treatment, and there is only a marginal investment into R&D for drug and vaccine development. In this context, identification of novel biomarkers able to transcend the current limits of diagnostic methods surfaces as a main priority in Chagas disease applied research. The expectation is that these novel biomarkers will provide reliable, reproducible and accurate results irrespective of the genetic background, infecting parasite strain, stage of disease, and clinical-associated features of Chagasic populations. In addition, they should be able to address other still unmet diagnostic needs, including early detection of congenital T. cruzi transmission, rapid assessment of treatment efficiency or failure, indication/prediction of disease progression and direct parasite typification in clinical samples. The lack of access of poor and neglected populations to essential diagnostics also stress the necessity of developing new methods operational in Point-of-Care (PoC) settings. In summary, emergent diagnostic tests integrating these novel and tailored tools should provide a significant impact on the effectiveness of current intervention schemes and on the clinical management of Chagasic patients. In this chapter, we discuss the present knowledge and possible future steps in Chagas disease diagnostic applications, as well as the opportunity provided by recent advances in high-throughput methods for biomarker discovery. PMID:28325368

Gene expression-based molecular diagnostic system for malignant gliomas is superior to histological diagnosis.

PubMed

Shirahata, Mitsuaki; Iwao-Koizumi, Kyoko; Saito, Sakae; Ueno, Noriko; Oda, Masashi; Hashimoto, Nobuo; Takahashi, Jun A; Kato, Kikuya

2007-12-15

Current morphology-based glioma classification methods do not adequately reflect the complex biology of gliomas, thus limiting their prognostic ability. In this study, we focused on anaplastic oligodendroglioma and glioblastoma, which typically follow distinct clinical courses. Our goal was to construct a clinically useful molecular diagnostic system based on gene expression profiling. The expression of 3,456 genes in 32 patients, 12 and 20 of whom had prognostically distinct anaplastic oligodendroglioma and glioblastoma, respectively, was measured by PCR array. Next to unsupervised methods, we did supervised analysis using a weighted voting algorithm to construct a diagnostic system discriminating anaplastic oligodendroglioma from glioblastoma. The diagnostic accuracy of this system was evaluated by leave-one-out cross-validation. The clinical utility was tested on a microarray-based data set of 50 malignant gliomas from a previous study. Unsupervised analysis showed divergent global gene expression patterns between the two tumor classes. A supervised binary classification model showed 100% (95% confidence interval, 89.4-100%) diagnostic accuracy by leave-one-out cross-validation using 168 diagnostic genes. Applied to a gene expression data set from a previous study, our model correlated better with outcome than histologic diagnosis, and also displayed 96.6% (28 of 29) consistency with the molecular classification scheme used for these histologically controversial gliomas in the original article. Furthermore, we observed that histologically diagnosed glioblastoma samples that shared anaplastic oligodendroglioma molecular characteristics tended to be associated with longer survival. Our molecular diagnostic system showed reproducible clinical utility and prognostic ability superior to traditional histopathologic diagnosis for malignant glioma.

Magnetic resonance neurography and diffusion tensor imaging: origins, history, and clinical impact of the first 50,000 cases with an assessment of efficacy and utility in a prospective 5000-patient study group.

PubMed

Filler, Aaron

2009-10-01

Methods were invented that made it possible to image peripheral nerves in the body and to image neural tracts in the brain. The history, physical basis, and dyadic tensor concept underlying the methods are reviewed. Over a 15-year period, these techniques-magnetic resonance neurography (MRN) and diffusion tensor imaging-were deployed in the clinical and research community in more than 2500 published research reports and applied to approximately 50,000 patients. Within this group, approximately 5000 patients having MRN were carefully tracked on a prospective basis. A uniform Neurography imaging methodology was applied in the study group, and all images were reviewed and registered by referral source, clinical indication, efficacy of imaging, and quality. Various classes of image findings were identified and subjected to a variety of small targeted prospective outcome studies. Those findings demonstrated to be clinically significant were then tracked in the larger clinical volume data set. MRN demonstrates mechanical distortion of nerves, hyperintensity consistent with nerve irritation, nerve swelling, discontinuity, relations of nerves to masses, and image features revealing distortion of nerves at entrapment points. These findings are often clinically relevant and warrant full consideration in the diagnostic process. They result in specific pathological diagnoses that are comparable to electrodiagnostic testing in clinical efficacy. A review of clinical outcome studies with diffusion tensor imaging also shows convincing utility. MRN and diffusion tensor imaging neural tract imaging have been validated as indispensable clinical diagnostic methods that provide reliable anatomic pathological information. There is no alternative diagnostic method in many situations. With the elapsing of 15 years, tens of thousands of imaging studies, and thousands of publications, these methods should no longer be considered experimental.

Cognitive aspect of diagnostic errors.

PubMed

Phua, Dong Haur; Tan, Nigel C K

2013-01-01

Diagnostic errors can result in tangible harm to patients. Despite our advances in medicine, the mental processes required to make a diagnosis exhibits shortcomings, causing diagnostic errors. Cognitive factors are found to be an important cause of diagnostic errors. With new understanding from psychology and social sciences, clinical medicine is now beginning to appreciate that our clinical reasoning can take the form of analytical reasoning or heuristics. Different factors like cognitive biases and affective influences can also impel unwary clinicians to make diagnostic errors. Various strategies have been proposed to reduce the effect of cognitive biases and affective influences when clinicians make diagnoses; however evidence for the efficacy of these methods is still sparse. This paper aims to introduce the reader to the cognitive aspect of diagnostic errors, in the hope that clinicians can use this knowledge to improve diagnostic accuracy and patient outcomes.

[The clinical manifestations and diagnostics of otitis media caused by tuberculosis].

PubMed

Kryukov, A I; Garov, E V; Ivoilov, A Yu; Shadrin, G B; Sidorina, N G; Lavrova, A S

2015-01-01

The objective of the present study was to clarify the characteristic pathognomonic features of middle ear lesions associated with tuberculosis and the approaches to their diagnostics under the present-day conditions. The study included 11 cases (18 ears) of tuberculosis otitis media and the related lesions of the mastoid process diagnosed with the use of clinical, roentgenological, cytological, bacteriological, pathomorphological, and molecular-genetic methods (including PCR diagnostics). The primary localization of tuberculosis in the middle ear was documented in 6 patients; in 5 patients, it was associated with pulmonary involvement. Five patients presented with smoldering exudative otitis media and the remaining six ones with suppurative perforating otitis media. The tuberculous process was diagnosed with the use of various methods including clinical examination, bacteriological (9%), cytological (27.3%), pathomorphological (18%) studies, and PCR diagnostics (55%). Diagnosis was made within a period from 1 month to 1.5 years after the application of the patients for medical assistance which suggests the difficulty of verification of tuberculous etiology of the disease of the middle ear. It is concluded that the high index of suspicion in the case of smoldering middle ear pathology facilitates its early diagnostics and successful treatment.

Electrophysiology of Cranial Nerve Testing: Trigeminal and Facial Nerves.

PubMed

Muzyka, Iryna M; Estephan, Bachir

2018-01-01

The clinical examination of the trigeminal and facial nerves provides significant diagnostic value, especially in the localization of lesions in disorders affecting the central and/or peripheral nervous system. The electrodiagnostic evaluation of these nerves and their pathways adds further accuracy and reliability to the diagnostic investigation and the localization process, especially when different testing methods are combined based on the clinical presentation and the electrophysiological findings. The diagnostic uniqueness of the trigeminal and facial nerves is their connectivity and their coparticipation in reflexes commonly used in clinical practice, namely the blink and corneal reflexes. The other reflexes used in the diagnostic process and lesion localization are very nerve specific and add more diagnostic yield to the workup of certain disorders of the nervous system. This article provides a review of commonly used electrodiagnostic studies and techniques in the evaluation and lesion localization of cranial nerves V and VII.

Single-cell proteomics: potential implications for cancer diagnostics.

PubMed

Gavasso, Sonia; Gullaksen, Stein-Erik; Skavland, Jørn; Gjertsen, Bjørn T

2016-01-01

Single-cell proteomics in cancer is evolving and promises to provide more accurate diagnoses based on detailed molecular features of cells within tumors. This review focuses on technologies that allow for collection of complex data from single cells, but also highlights methods that are adaptable to routine cancer diagnostics. Current diagnostics rely on histopathological analysis, complemented by mutational detection and clinical imaging. Though crucial, the information gained is often not directly transferable to defined therapeutic strategies, and predicting therapy response in a patient is difficult. In cancer, cellular states revealed through perturbed intracellular signaling pathways can identify functional mutations recurrent in cancer subsets. Single-cell proteomics remains to be validated in clinical trials where serial samples before and during treatment can reveal excessive clonal evolution and therapy failure; its use in clinical trials is anticipated to ignite a diagnostic revolution that will better align diagnostics with the current biological understanding of cancer.

An evidence-based diagnostic classification system for low back pain

PubMed Central

Vining, Robert; Potocki, Eric; Seidman, Michael; Morgenthal, A. Paige

2013-01-01

Introduction: While clinicians generally accept that musculoskeletal low back pain (LBP) can arise from specific tissues, it remains difficult to confirm specific sources. Methods: Based on evidence supported by diagnostic utility studies, doctors of chiropractic functioning as members of a research clinic created a diagnostic classification system, corresponding exam and checklist based on strength of evidence, and in-office efficiency. Results: The diagnostic classification system contains one screening category, two pain categories: Nociceptive, Neuropathic, one functional evaluation category, and one category for unknown or poorly defined diagnoses. Nociceptive and neuropathic pain categories are each divided into 4 subcategories. Conclusion: This article describes and discusses the strength of evidence surrounding diagnostic categories for an in-office, clinical exam and checklist tool for LBP diagnosis. The use of a standardized tool for diagnosing low back pain in clinical and research settings is encouraged. PMID:23997245

Diagnostic microbiology in veterinary dermatology: present and future.

PubMed

Guardabassi, Luca; Damborg, Peter; Stamm, Ivonne; Kopp, Peter A; Broens, Els M; Toutain, Pierre-Louis

2017-02-01

The microbiology laboratory can be perceived as a service provider rather than an integral part of the healthcare team. The aim of this review is to discuss the current challenges of providing a state-of-the-art diagnostic veterinary microbiology service including the identification (ID) and antimicrobial susceptibility testing (AST) of key pathogens in veterinary dermatology. The Study Group for Veterinary Microbiology (ESGVM) of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) identified scientific, technological, educational and regulatory issues impacting the predictive value of AST and the quality of the service offered by microbiology laboratories. The advent of mass spectrometry has significantly reduced the time required for ID of key pathogens such as Staphylococcus pseudintermedius. However, the turnaround time for validated AST methods has remained unchanged for many years. Beyond scientific and technological constraints, AST methods are not harmonized and clinical breakpoints for some antimicrobial drugs are either missing or inadequate. Small laboratories, including in-clinic laboratories, are usually not adequately equipped to run up-to-date clinical microbiologic diagnostic tests. ESGVM recommends the use of laboratories employing mass spectrometry for ID and broth micro-dilution for AST, and offering assistance by expert microbiologists on pre- and post-analytical issues. Setting general standards for veterinary clinical microbiology, promoting antimicrobial stewardship, and the development of new, validated and rapid diagnostic methods, especially for AST, are among the missions of ESGVM. © 2017 The Authors. Veterinary Dermatology published by John Wiley & Sons Ltd on behalf of the ESVD and ACVD.

Molecular and Nonmolecular Diagnostic Methods for Invasive Fungal Infections

PubMed Central

Arvanitis, Marios; Anagnostou, Theodora; Fuchs, Beth Burgwyn; Caliendo, Angela M.

2014-01-01

SUMMARY Invasive fungal infections constitute a serious threat to an ever-growing population of immunocompromised individuals and other individuals at risk. Traditional diagnostic methods, such as histopathology and culture, which are still considered the gold standards, have low sensitivity, which underscores the need for the development of new means of detecting fungal infectious agents. Indeed, novel serologic and molecular techniques have been developed and are currently under clinical evaluation. Tests like the galactomannan antigen test for aspergillosis and the β-glucan test for invasive Candida spp. and molds, as well as other antigen and antibody tests, for Cryptococcus spp., Pneumocystis spp., and dimorphic fungi, have already been established as important diagnostic approaches and are implemented in routine clinical practice. On the other hand, PCR and other molecular approaches, such as matrix-assisted laser desorption ionization (MALDI) and fluorescence in situ hybridization (FISH), have proved promising in clinical trials but still need to undergo standardization before their clinical use can become widespread. The purpose of this review is to highlight the different diagnostic approaches that are currently utilized or under development for invasive fungal infections and to identify their performance characteristics and the challenges associated with their use. PMID:24982319

Diagnostic work-up and loss of tuberculosis suspects in Jogjakarta, Indonesia

PubMed Central

2012-01-01

Background Early and accurate diagnosis of pulmonary tuberculosis (TB) is critical for successful TB control. To assist in the diagnosis of smear-negative pulmonary TB, the World Health Organisation (WHO) recommends the use of a diagnostic algorithm. Our study evaluated the implementation of the national tuberculosis programme's diagnostic algorithm in routine health care settings in Jogjakarta, Indonesia. The diagnostic algorithm is based on the WHO TB diagnostic algorithm, which had already been implemented in the health facilities. Methods We prospectively documented the diagnostic work-up of all new tuberculosis suspects until a diagnosis was reached. We used clinical audit forms to record each step chronologically. Data on the patient's gender, age, symptoms, examinations (types, dates, and results), and final diagnosis were collected. Results Information was recorded for 754 TB suspects; 43.5% of whom were lost during the diagnostic work-up in health centres, 0% in lung clinics. Among the TB suspects who completed diagnostic work-ups, 51.1% and 100.0% were diagnosed without following the national TB diagnostic algorithm in health centres and lung clinics, respectively. However, the work-up in the health centres and lung clinics generally conformed to international standards for tuberculosis care (ISTC). Diagnostic delays were significantly longer in health centres compared to lung clinics. Conclusions The high rate of patients lost in health centres needs to be addressed through the implementation of TB suspect tracing and better programme supervision. The national TB algorithm needs to be revised and differentiated according to the level of care. PMID:22333111

Clinical evaluation and validation of laboratory methods for the diagnosis of Bordetella pertussis infection: Culture, polymerase chain reaction (PCR) and anti-pertussis toxin IgG serology (IgG-PT).

PubMed

Lee, Adria D; Cassiday, Pamela K; Pawloski, Lucia C; Tatti, Kathleen M; Martin, Monte D; Briere, Elizabeth C; Tondella, M Lucia; Martin, Stacey W

2018-01-01

The appropriate use of clinically accurate diagnostic tests is essential for the detection of pertussis, a poorly controlled vaccine-preventable disease. The purpose of this study was to estimate the sensitivity and specificity of different diagnostic criteria including culture, multi-target polymerase chain reaction (PCR), anti-pertussis toxin IgG (IgG-PT) serology, and the use of a clinical case definition. An additional objective was to describe the optimal timing of specimen collection for the various tests. Clinical specimens were collected from patients with cough illness at seven locations across the United States between 2007 and 2011. Nasopharyngeal and blood specimens were collected from each patient during the enrollment visit. Patients who had been coughing for ≤ 2 weeks were asked to return in 2-4 weeks for collection of a second, convalescent blood specimen. Sensitivity and specificity of each diagnostic test were estimated using three methods-pertussis culture as the "gold standard," composite reference standard analysis (CRS), and latent class analysis (LCA). Overall, 868 patients were enrolled and 13.6% were B. pertussis positive by at least one diagnostic test. In a sample of 545 participants with non-missing data on all four diagnostic criteria, culture was 64.0% sensitive, PCR was 90.6% sensitive, and both were 100% specific by LCA. CRS and LCA methods increased the sensitivity estimates for convalescent serology and the clinical case definition over the culture-based estimates. Culture and PCR were most sensitive when performed during the first two weeks of cough; serology was optimally sensitive after the second week of cough. Timing of specimen collection in relation to onset of illness should be considered when ordering diagnostic tests for pertussis. Consideration should be given to including IgG-PT serology as a confirmatory test in the Council of State and Territorial Epidemiologists (CSTE) case definition for pertussis.

A Review of 20 Years of Research on Overdiagnosis and Underdiagnosis in the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) Project

PubMed Central

2016-01-01

The Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project represents an integration of research methodology into a community-based outpatient practice affiliated with an academic medical centre. The MIDAS project is the largest clinical epidemiological study using semi-structured interviews to assess a wide range of psychiatric disorders in a general clinical outpatient practice. In an early report from the MIDAS project, we found that across diagnostic categories clinicians using unstandardized, unstructured clinical interviews underrecognized diagnostic comorbidity, compared with the results of semi-structured interviews. Moreover, we found that the patients often wanted treatment for symptoms of disorders that were diagnosed as comorbid, rather than principal, conditions. This highlighted the importance, from the patient’s perspective, of conducting thorough diagnostic interviews to diagnose disorders that are not related to the patient’s chief complaint because patients often desire treatment for these additional diagnoses. While several of the initial papers from the MIDAS project identified problems with the detection of comorbid disorders in clinical practice, regarding the diagnosis of bipolar disorder we observed the emergence of an opposite phenomenon—clinician overdiagnosis. The results from the MIDAS project, along with other studies of diagnosis in routine clinical practice, have brought to the forefront the problem with diagnosis in routine clinical practice. An important question is what do these findings suggest about the community standard of care in making psychiatric diagnoses, and whether and how the standard of care should be changed? The implications are discussed. PMID:27253697

A Review of 20 Years of Research on Overdiagnosis and Underdiagnosis in the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) Project.

PubMed

Zimmerman, Mark

2016-02-01

The Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project represents an integration of research methodology into a community-based outpatient practice affiliated with an academic medical centre. The MIDAS project is the largest clinical epidemiological study using semi-structured interviews to assess a wide range of psychiatric disorders in a general clinical outpatient practice. In an early report from the MIDAS project, we found that across diagnostic categories clinicians using unstandardized, unstructured clinical interviews underrecognized diagnostic comorbidity, compared with the results of semi-structured interviews. Moreover, we found that the patients often wanted treatment for symptoms of disorders that were diagnosed as comorbid, rather than principal, conditions. This highlighted the importance, from the patient's perspective, of conducting thorough diagnostic interviews to diagnose disorders that are not related to the patient's chief complaint because patients often desire treatment for these additional diagnoses. While several of the initial papers from the MIDAS project identified problems with the detection of comorbid disorders in clinical practice, regarding the diagnosis of bipolar disorder we observed the emergence of an opposite phenomenon-clinician overdiagnosis. The results from the MIDAS project, along with other studies of diagnosis in routine clinical practice, have brought to the forefront the problem with diagnosis in routine clinical practice. An important question is what do these findings suggest about the community standard of care in making psychiatric diagnoses, and whether and how the standard of care should be changed? The implications are discussed. © The Author(s) 2016.

The modern trends of the evolution laser information technology in oncology

NASA Astrophysics Data System (ADS)

Mikov, A. A.; Svirin, V. N.

2008-04-01

Laser-optical information technologies and devices develop since the 70- years at the end of 20 century and are broadly used for diagnostics and treatment of oncological diseases to date. Although such methods as photodynamic therapy (PDT), laser-induce thermotherapy (LITT), fluorescent diagnostics and spectrophotometry already more than 30 years are used for treatment and diagnostics of oncological diseases, nevertheless, they are enough new methods and, as a rule, are used in large scientific centers and medical institutions. This is bound, first of all, with lack of information on modern method of cancer treatment, the absence of widely available laser procedures and corresponding devices in the polyclinics and even in district hospitals, as well as insufficient understanding of application areas, where laser methods has an advantage by comparison, for instance, with beam or chemotherapy. At present day laser methods are fast upcoming direction of the treatment oncological diseases. This is explained by progress in development essentially laser, particularly diode, improvement electronic and computing components and broad introduction software-algorithmic methods of control the undertaking therapeutic and diagnostic procedures. In article are considered new laser methods of the undertaking diagnostic and therapeutic procedures and is shown that introduction multiwave laser radiation for probe and influences on tissue, the different methods of the determination of the functional state of tissues, realization of the on-line diagnostics when carrying out the therapeutic procedures, automatic control systems of the power laser radiation, which depends on state patient tissue, as well as software-algorithmic methods of management session therapeutic and diagnostic procedures greatly raises efficiency of the treatment oncological diseases. On an example of the multipurpose laser therapeutic devices("MLTA") developed and introduced in clinical practice and multipurpose laser diagnostic complexes ("MLDC"), the realizing offered methods, are shown the basic tendencies of development laser methods in oncology, concrete technical decisions and the experimental clinical material showing increase of efficiency of treatment of a cancer at their realization are resulted. It is shown, that realization of the offered methods and technical technologies opens new competitive advantages laser technologies in comparison with beam and chemical-therapy at treatment of oncological diseases.

[Vest recorder used in diagnostics of occasionally occurring supraventricular tachycardia nearby sinus node - a case report].

PubMed

Adamczyk, Karolina; Średniawa, Beata; Mitręga, Katarzyna; Morawski, Stanisław; Musialik-Łydka, Agata; Kalarus, Zbigniew

2016-09-29

Symptoms such as palpitations, fainting, dizziness and unexplained loss of consciousness are often notified by patients in clinical practice. Cardiological causes of these ailments could be various, inter alia, atriaventricular conduction disorders, supraventricular arrythmias or more life-threatening ventricular arrythmias. Diagnostics of these disorders includes a series of basic non-invasive research and more advanced specialistic methods. Presented case report shows problems of arrythmias diagnostics and imperfections of avaible methods.

Correcting AUC for Measurement Error.

PubMed

Rosner, Bernard; Tworoger, Shelley; Qiu, Weiliang

2015-12-01

Diagnostic biomarkers are used frequently in epidemiologic and clinical work. The ability of a diagnostic biomarker to discriminate between subjects who develop disease (cases) and subjects who do not (controls) is often measured by the area under the receiver operating characteristic curve (AUC). The diagnostic biomarkers are usually measured with error. Ignoring measurement error can cause biased estimation of AUC, which results in misleading interpretation of the efficacy of a diagnostic biomarker. Several methods have been proposed to correct AUC for measurement error, most of which required the normality assumption for the distributions of diagnostic biomarkers. In this article, we propose a new method to correct AUC for measurement error and derive approximate confidence limits for the corrected AUC. The proposed method does not require the normality assumption. Both real data analyses and simulation studies show good performance of the proposed measurement error correction method.

Whole Genome Sequencing Increases Molecular Diagnostic Yield Compared with Current Diagnostic Testing for Inherited Retinal Disease.

PubMed

Ellingford, Jamie M; Barton, Stephanie; Bhaskar, Sanjeev; Williams, Simon G; Sergouniotis, Panagiotis I; O'Sullivan, James; Lamb, Janine A; Perveen, Rahat; Hall, Georgina; Newman, William G; Bishop, Paul N; Roberts, Stephen A; Leach, Rick; Tearle, Rick; Bayliss, Stuart; Ramsden, Simon C; Nemeth, Andrea H; Black, Graeme C M

2016-05-01

To compare the efficacy of whole genome sequencing (WGS) with targeted next-generation sequencing (NGS) in the diagnosis of inherited retinal disease (IRD). Case series. A total of 562 patients diagnosed with IRD. We performed a direct comparative analysis of current molecular diagnostics with WGS. We retrospectively reviewed the findings from a diagnostic NGS DNA test for 562 patients with IRD. A subset of 46 of 562 patients (encompassing potential clinical outcomes of diagnostic analysis) also underwent WGS, and we compared mutation detection rates and molecular diagnostic yields. In addition, we compared the sensitivity and specificity of the 2 techniques to identify known single nucleotide variants (SNVs) using 6 control samples with publically available genotype data. Diagnostic yield of genomic testing. Across known disease-causing genes, targeted NGS and WGS achieved similar levels of sensitivity and specificity for SNV detection. However, WGS also identified 14 clinically relevant genetic variants through WGS that had not been identified by NGS diagnostic testing for the 46 individuals with IRD. These variants included large deletions and variants in noncoding regions of the genome. Identification of these variants confirmed a molecular diagnosis of IRD for 11 of the 33 individuals referred for WGS who had not obtained a molecular diagnosis through targeted NGS testing. Weighted estimates, accounting for population structure, suggest that WGS methods could result in an overall 29% (95% confidence interval, 15-45) uplift in diagnostic yield. We show that WGS methods can detect disease-causing genetic variants missed by current NGS diagnostic methodologies for IRD and thereby demonstrate the clinical utility and additional value of WGS. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Gram stain method shows better sensitivity than clinical criteria for detection of bacterial vaginosis in surveillance of pregnant, low-income women in a clinical setting.

PubMed Central

Tam, M T; Yungbluth, M; Myles, T

1998-01-01

OBJECTIVE: The purpose of the study is to determine whether the Gram stain method is superior to the clinical criteria for the diagnosis of bacterial vaginosis in low-income pregnant women seen in a resident clinic setting. The clinical criteria is the current diagnostic method employed to diagnose bacterial vaginosis. STUDY DESIGN: In this study, 51 pregnant women with vaginal discharge were prospectively evaluated. All were screened using the clinical criteria, Gram stain method, and culture of the discharge. The modified scoring system instituted by Nugent et al. (J Clin Microbiol 29:297-301, 1991) was employed in reading the Gram stain smears. The clinical criteria were then compared with the Gram stain method. Isolation of moderate to many Gardnerella vaginalis growth by culture was used as the confirmatory finding. RESULTS: Sensitivity of the Gram stain method (91%) was significantly higher than that of the clinical criteria (46%), (sign test P = 0.0023, < 0.01). The Gram stain method also has both a low false-negative (4%) and high negative predictive value (96%), making it an ideal diagnostic test. CONCLUSION: The Gram stain method is a rapid and cost-effective test that is also highly reproducible and readily available in many laboratories. These features make the Gram stain method a more desirable screening procedure for bacterial vaginosis in a clinic population. PMID:9894174

Microcomputer Calculated Diagnostic X-Ray Exposure Factors: Clinical Evaluation

PubMed Central

Markivee, C. R.; Edwards, F. Marc; Leonard, Patricia

1981-01-01

Calculation of correct settings for the controls of a diagnostic x-ray machine was established as feasible in a microcomputer with 4K memory. The cost effectiveness and other findings in the application of this method are discussed.

Diagnostic trends in Clostridium difficile detection in Finnish microbiology laboratories.

PubMed

Könönen, Eija; Rasinperä, Marja; Virolainen, Anni; Mentula, Silja; Lyytikäinen, Outi

2009-12-01

Due to increased interest directed to Clostridium difficile-associated infections, a questionnaire survey of laboratory diagnostics of toxin-producing C. difficile was conducted in Finland in June 2006. Different aspects pertaining to C. difficile diagnosis, such as requests and criteria used for testing, methods used for its detection, yearly changes in diagnostics since 1996, and the total number of investigations positive for C. difficile in 2005, were asked in the questionnaire, which was sent to 32 clinical microbiology laboratories, including all hospital-affiliated and the relevant private clinical microbiology laboratories in Finland. The situation was updated by phone and email correspondence in September 2008. In June 2006, 28 (88%) laboratories responded to the questionnaire survey; 24 of them reported routinely testing requested stool specimens for C. difficile. Main laboratory methods included toxin detection (21/24; 88%) and/or anaerobic culture (19/24; 79%). In June 2006, 18 (86%) of the 21 laboratories detecting toxins directly from feces, from the isolate, or both used methods for both toxin A (TcdA) and B (TcdB), whereas only one laboratory did so in 1996. By September 2008, all of the 23 laboratories performing diagnostics for C. difficile used methods for both TcdA and TcdB. In 2006, the number of specimens processed per 100,000 population varied remarkably between different hospital districts. In conclusion, culturing C. difficile is common and there has been a favorable shift in toxin detection practice in Finnish clinical microbiology laboratories. However, the variability in diagnostic activity reported in 2006 creates a challenge for national monitoring of the epidemiology of C. difficile and related diseases.

Diagnostic methods for insect sting allergy.

PubMed

Hamilton, Robert G

2004-08-01

This review overviews advances from mid-2002 to the present in the validation and performance methods used in the diagnosis of Hymenoptera venom-induced immediate-type hypersensitivity. The general diagnostic algorithm for insect sting allergy is initially discussed with an examination of the AAAAI's 2003 revised practice parameter guidelines. Changes as a result of a greater recognition of skin test negative systemic reactors include repeat analysis of all testing and acceptance of serology as a complementary diagnostic test to the skin test. Original data examining concordance of venom-specific IgE results produced by the second-generation Pharmacia CAP System with the Johns Hopkins University radioallergosorbent test are presented. Diagnostic performance of honeybee venom-specific IgE assays used in clinical laboratories in North America is discussed using data from the Diagnostic Allergy Proficiency Survey conducted by the College of American Pathologists. Validity of venom-specific IgE antibody in postmortem blood specimens is demonstrated. The utility of alternative in-vivo (provocation) and in-vitro (basophil-based) diagnostic testing methods is critiqued. This overview supports the following conclusions. Improved practice parameter guidelines include serology and skin test as complementary in supporting a positive clinical history during the diagnostic process. Data are provided which support the analytical performance of commercially available venom-specific IgE antibody serology-based assays. Intentional sting challenge in-vivo provocation, in-vitro basophil flow cytometry (CD63, CD203c) based assays, and in-vitro basophil histamine and sulfidoleukotriene release assays have their utility in the study of difficult diagnostic cases, but their use will remain as supplementary, secondary diagnostic tests.

Whole exome sequencing in neurogenetic odysseys: An effective, cost- and time-saving diagnostic approach

PubMed Central

Córdoba, Marta; Rodriguez-Quiroga, Sergio Alejandro; Vega, Patricia Analía; Salinas, Valeria; Perez-Maturo, Josefina; Amartino, Hernán; Vásquez-Dusefante, Cecilia; Medina, Nancy; González-Morón, Dolores; Kauffman, Marcelo Andrés

2018-01-01

Background Diagnostic trajectories for neurogenetic disorders frequently require the use of considerable time and resources, exposing patients and families to so-called “diagnostic odysseys”. Previous studies have provided strong evidence for increased diagnostic and clinical utility of whole-exome sequencing in medical genetics. However, specific reports assessing its utility in a setting such as ours- a neurogeneticist led academic group serving in a low-income country—are rare. Objectives To assess the diagnostic yield of WES in patients suspected of having a neurogenetic condition and explore the cost-effectiveness of its implementation in a research group located in an Argentinean public hospital. Methods This is a prospective study of the clinical utility of WES in a series of 40 consecutive patients selected from a Neurogenetic Clinic of a tertiary Hospital in Argentina. We evaluated patients retrospectively for previous diagnostic trajectories. Diagnostic yield, clinical impact on management and economic diagnostic burden were evaluated. Results We demonstrated the clinical utility of Whole Exome Sequencing in our patient cohort, obtaining a diagnostic yield of 40% (95% CI, 24.8%-55.2%) among a diverse group of neurological disorders. The average age at the time of WES was 23 (range 3–70). The mean time elapsed from symptom onset to WES was 11 years (range 3–42). The mean cost of the diagnostic workup prior to WES was USD 1646 (USD 1439 to 1853), which is 60% higher than WES cost in our center. Conclusions WES for neurogenetics proved to be an effective, cost- and time-saving approach for the molecular diagnosis of this heterogeneous and complex group of patients. PMID:29389947

Designs and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics.

PubMed

Simon, Richard

2008-06-01

Developments in genomics and biotechnology provide unprecedented opportunities for the development of effective therapeutics and companion diagnostics for matching the right drug to the right patient. Effective co-development involves many new challenges with increased opportunity for success as well as delay and failure. Clinical trial designs and adaptive analysis plans for the prospective design of pivotal trials of new therapeutics and companion diagnostics are reviewed. Effective co-development requires careful prospective planning of the design and analysis strategy for pivotal clinical trials. Randomized clinical trials continue to be important for evaluating the effectiveness of new treatments, but the target populations for analysis should be prospectively specified based on the companion diagnostic. Post hoc analyses of traditionally designed randomized clinical trials are often deeply problematic. Clear separation is generally required of the data used for developing the diagnostic test, including their threshold of positivity, from the data used for evaluating treatment effectiveness in subsets determined by the test. Adaptive analysis can be used to provide flexibility to the analysis but the use of such methods requires careful planning and prospective definition in order to assure that the pivotal trial adequately limits the chance of erroneous conclusions.

Cost-Effectiveness Analysis of Diagnostic Options for Pneumocystis Pneumonia (PCP)

PubMed Central

Harris, Julie R.; Marston, Barbara J.; Sangrujee, Nalinee; DuPlessis, Desiree; Park, Benjamin

2011-01-01

Background Diagnosis of Pneumocystis jirovecii pneumonia (PCP) is challenging, particularly in developing countries. Highly sensitive diagnostic methods are costly, while less expensive methods often lack sensitivity or specificity. Cost-effectiveness comparisons of the various diagnostic options have not been presented. Methods and Findings We compared cost-effectiveness, as measured by cost per life-years gained and proportion of patients successfully diagnosed and treated, of 33 PCP diagnostic options, involving combinations of specimen collection methods [oral washes, induced and expectorated sputum, and bronchoalveolar lavage (BAL)] and laboratory diagnostic procedures [various staining procedures or polymerase chain reactions (PCR)], or clinical diagnosis with chest x-ray alone. Our analyses were conducted from the perspective of the government payer among ambulatory, HIV-infected patients with symptoms of pneumonia presenting to HIV clinics and hospitals in South Africa. Costing data were obtained from the National Institutes of Communicable Diseases in South Africa. At 50% disease prevalence, diagnostic procedures involving expectorated sputum with any PCR method, or induced sputum with nested or real-time PCR, were all highly cost-effective, successfully treating 77–90% of patients at $26–51 per life-year gained. Procedures using BAL specimens were significantly more expensive without added benefit, successfully treating 68–90% of patients at costs of $189–232 per life-year gained. A relatively cost-effective diagnostic procedure that did not require PCR was Toluidine Blue O staining of induced sputum ($25 per life-year gained, successfully treating 68% of patients). Diagnosis using chest x-rays alone resulted in successful treatment of 77% of patients, though cost-effectiveness was reduced ($109 per life-year gained) compared with several molecular diagnostic options. Conclusions For diagnosis of PCP, use of PCR technologies, when combined with less-invasive patient specimens such as expectorated or induced sputum, represent more cost-effective options than any diagnostic procedure using BAL, or chest x-ray alone. PMID:21858013

Probability or Reasoning: Current Thinking and Realistic Strategies for Improved Medical Decisions

PubMed Central

2017-01-01

A prescriptive model approach in decision making could help achieve better diagnostic accuracy in clinical practice through methods that are less reliant on probabilistic assessments. Various prescriptive measures aimed at regulating factors that influence heuristics and clinical reasoning could support clinical decision-making process. Clinicians could avoid time-consuming decision-making methods that require probabilistic calculations. Intuitively, they could rely on heuristics to obtain an accurate diagnosis in a given clinical setting. An extensive literature review of cognitive psychology and medical decision-making theory was performed to illustrate how heuristics could be effectively utilized in daily practice. Since physicians often rely on heuristics in realistic situations, probabilistic estimation might not be a useful tool in everyday clinical practice. Improvements in the descriptive model of decision making (heuristics) may allow for greater diagnostic accuracy. PMID:29209469

Probability or Reasoning: Current Thinking and Realistic Strategies for Improved Medical Decisions.

PubMed

Nantha, Yogarabindranath Swarna

2017-11-01

A prescriptive model approach in decision making could help achieve better diagnostic accuracy in clinical practice through methods that are less reliant on probabilistic assessments. Various prescriptive measures aimed at regulating factors that influence heuristics and clinical reasoning could support clinical decision-making process. Clinicians could avoid time-consuming decision-making methods that require probabilistic calculations. Intuitively, they could rely on heuristics to obtain an accurate diagnosis in a given clinical setting. An extensive literature review of cognitive psychology and medical decision-making theory was performed to illustrate how heuristics could be effectively utilized in daily practice. Since physicians often rely on heuristics in realistic situations, probabilistic estimation might not be a useful tool in everyday clinical practice. Improvements in the descriptive model of decision making (heuristics) may allow for greater diagnostic accuracy.

Systematic Review and Meta-Analysis of Studies Evaluating Diagnostic Test Accuracy: A Practical Review for Clinical Researchers-Part II. Statistical Methods of Meta-Analysis

PubMed Central

Lee, Juneyoung; Kim, Kyung Won; Choi, Sang Hyun; Huh, Jimi

2015-01-01

Meta-analysis of diagnostic test accuracy studies differs from the usual meta-analysis of therapeutic/interventional studies in that, it is required to simultaneously analyze a pair of two outcome measures such as sensitivity and specificity, instead of a single outcome. Since sensitivity and specificity are generally inversely correlated and could be affected by a threshold effect, more sophisticated statistical methods are required for the meta-analysis of diagnostic test accuracy. Hierarchical models including the bivariate model and the hierarchical summary receiver operating characteristic model are increasingly being accepted as standard methods for meta-analysis of diagnostic test accuracy studies. We provide a conceptual review of statistical methods currently used and recommended for meta-analysis of diagnostic test accuracy studies. This article could serve as a methodological reference for those who perform systematic review and meta-analysis of diagnostic test accuracy studies. PMID:26576107

Methods for Real-Time PCR-Based Diagnosis of Chlamydia pneumoniae, Chlamydia psittaci, and Chlamydia abortus Infections in an Opened Molecular Diagnostic Platform.

PubMed

Opota, Onya; Brouillet, René; Greub, Gilbert; Jaton, Katia

2017-01-01

The advances in molecular biology of the last decades have dramatically improved the field of diagnostic bacteriology. In particular, PCR-based technologies have impacted the diagnosis of infections caused by obligate intracellular bacteria such as pathogens from the Chlamydiacae family. Here, we describe a real-time PCR-based method using the Taqman technology for the diagnosis of Chlamydia pneumoniae, Chlamydia psittaci, and Chlamydia abortus infection. The method presented here can be applied to various clinical samples and can be adapted on opened molecular diagnostic platforms.

Multi-spectral fiber spectroscopy in 0,4-16μm range for biomedical applications(Conference Presentation)

NASA Astrophysics Data System (ADS)

Artyushenko, Viacheslav

2017-02-01

Various biomedical applications of fiber optics in a broad spectral range 0,4-16μm span from endoscopic imaging and Photo Dynamic Diagnostics (PDD) to laser power delivery for minimal invasive laser surgery, tissue coagulation and welding, Photo Dynamic Therapy (PDT), etc. Present review will highlight the latest results in advanced fiber solutions for a precise tissue diagnostics and control of some therapy methods - for so called "theranostic". Spectral fiber sensing for label free analysis of tissue composition helps to differentiate malignant and normal tissue to secure minimal invasive, but complete tumor removal or treatment. All key methods of Raman, fluorescence, diffuse reflection & MIR-absorption spectroscopy will be compared when used for the same spot of tissue - to select the most specific, sensitive and accurate method or to combine them for the synergy enhanced effect. The most informative spectral features for distinct organs/ tumor can be used to design special fiber sensors to be developed for portable and low cost applications with modern IT-features. Examples of multi-spectral tissue diagnostics promising for the future clinical applications will be presented to enable reduced mortality from cancer in the future. Translation of described methods into clinical practice will be discussed in comparison with the other method of optical diagnostics which should enhance modern medicine by less invasive, more precise and more effective methods of therapy to be fused with in-vivo diagnostics sensors & systems.

[Pilot tests using molecular diagnostic assay cervicovaginal infection during pregnancy].

PubMed

Beltrán-Montoya, J; Escudero-Gontes, S; Martínez-Huerta, N E; Ávila-Vergara, M A; Morales-Hernández, V; Canchola-Sotelo, C; Palacios-González, B; Vadillo-Ortega, F

2016-08-01

The prevalence of cervicovaginal infections during pregnancy has been associated with adverse perinatal outcomes however, the actual approach used for diagnosis is not effective. The aim of this study was to compare the diagnosis of vaginal infections in pregnant women using clinical, molecular diagnostic and traditional microbiological culture in a pilot study, to determine the prevalence and association with the development of preterm labor. We performed a nested cross-sectional study composed by 54 women in a cohort of pregnant women in Mexico City. Cervicovaginal infections were evaluated by clinical methods, microbiology culture and a commercially available molecular biology test. Prevalence of cervicovaginal infections during pregnancy was estimated between 28% and 50% according to methodologies. Considering the clinical diagnosis of preterm labor as the gold standard, all diagnostic tests were poor as predictors of preterm labor. Traditional approaches to establish the significance of cervicovaginal infection in pregnancy are exhausted, so be sought new ways to understand this complex relationship. Meanwhile it is recommended to continue to use traditional methods to identify infections during pregnancy in both knowledge of new methods aimed at understanding these relationships are sophisticated.

A computational framework for converting textual clinical diagnostic criteria into the quality data model.

PubMed

Hong, Na; Li, Dingcheng; Yu, Yue; Xiu, Qiongying; Liu, Hongfang; Jiang, Guoqian

2016-10-01

Constructing standard and computable clinical diagnostic criteria is an important but challenging research field in the clinical informatics community. The Quality Data Model (QDM) is emerging as a promising information model for standardizing clinical diagnostic criteria. To develop and evaluate automated methods for converting textual clinical diagnostic criteria in a structured format using QDM. We used a clinical Natural Language Processing (NLP) tool known as cTAKES to detect sentences and annotate events in diagnostic criteria. We developed a rule-based approach for assigning the QDM datatype(s) to an individual criterion, whereas we invoked a machine learning algorithm based on the Conditional Random Fields (CRFs) for annotating attributes belonging to each particular QDM datatype. We manually developed an annotated corpus as the gold standard and used standard measures (precision, recall and f-measure) for the performance evaluation. We harvested 267 individual criteria with the datatypes of Symptom and Laboratory Test from 63 textual diagnostic criteria. We manually annotated attributes and values in 142 individual Laboratory Test criteria. The average performance of our rule-based approach was 0.84 of precision, 0.86 of recall, and 0.85 of f-measure; the performance of CRFs-based classification was 0.95 of precision, 0.88 of recall and 0.91 of f-measure. We also implemented a web-based tool that automatically translates textual Laboratory Test criteria into the QDM XML template format. The results indicated that our approaches leveraging cTAKES and CRFs are effective in facilitating diagnostic criteria annotation and classification. Our NLP-based computational framework is a feasible and useful solution in developing diagnostic criteria representation and computerization. Copyright © 2016 Elsevier Inc. All rights reserved.

A Diagnostic Model for Dementia in Clinical Practice-Case Methodology Assisting Dementia Diagnosis.

PubMed

Londos, Elisabet

2015-04-02

Dementia diagnosis is important for many different reasons. Firstly, to separate dementia, or major neurocognitive disorder, from MCI (mild cognitive impairment), mild neurocognitive disorder. Secondly, to define the specific underlying brain disorder to aid treatment, prognosis and decisions regarding care needs and assistance. The diagnostic method of dementias is a puzzle of different data pieces to be fitted together in the best possible way to reach a clinical diagnosis. Using a modified case methodology concept, risk factors affecting cognitive reserve and symptoms constituting the basis of the brain damage hypothesis, can be visualized, balanced and reflected against test results as well as structural and biochemical markers. The model's origin is the case method initially described in Harvard business school, here modified to serve dementia diagnostics.

A Diagnostic Model for Dementia in Clinical Practice—Case Methodology Assisting Dementia Diagnosis

PubMed Central

Londos, Elisabet

2015-01-01

Dementia diagnosis is important for many different reasons. Firstly, to separate dementia, or major neurocognitive disorder, from MCI (mild cognitive impairment), mild neurocognitive disorder. Secondly, to define the specific underlying brain disorder to aid treatment, prognosis and decisions regarding care needs and assistance. The diagnostic method of dementias is a puzzle of different data pieces to be fitted together in the best possible way to reach a clinical diagnosis. Using a modified case methodology concept, risk factors affecting cognitive reserve and symptoms constituting the basis of the brain damage hypothesis, can be visualized, balanced and reflected against test results as well as structural and biochemical markers. The model’s origin is the case method initially described in Harvard business school, here modified to serve dementia diagnostics. PMID:26854146

Progress in the molecular diagnosis of Lyme disease.

PubMed

Ružić-Sabljić, Eva; Cerar, Tjaša

2017-01-01

Current laboratory testing of Lyme borreliosis mostly relies on serological methods with known limitations. Diagnostic modalities enabling direct detection of pathogen at the onset of the clinical signs could overcome some of the limitations. Molecular methods detecting borrelial DNA seem to be the ideal solution, although there are some aspects that need to be considered. Areas covered: This review represent summary and discussion of the published data obtained from literature searches from PubMed and The National Library of Medicine (USA) together with our own experience on molecular diagnosis of Lyme disease. Expert commentary: Molecular methods are promising and currently serve as supporting diagnostic testing in Lyme borreliosis. Since the field of molecular diagnostics is under rapid development, molecular testing could become an important diagnostic modality.

The rare and undiagnosed diseases diagnostic service - application of massively parallel sequencing in a state-wide clinical service.

PubMed

Baynam, Gareth; Pachter, Nicholas; McKenzie, Fiona; Townshend, Sharon; Slee, Jennie; Kiraly-Borri, Cathy; Vasudevan, Anand; Hawkins, Anne; Broley, Stephanie; Schofield, Lyn; Verhoef, Hedwig; Walker, Caroline E; Molster, Caron; Blackwell, Jenefer M; Jamieson, Sarra; Tang, Dave; Lassmann, Timo; Mina, Kym; Beilby, John; Davis, Mark; Laing, Nigel; Murphy, Lesley; Weeramanthri, Tarun; Dawkins, Hugh; Goldblatt, Jack

2016-06-11

The Rare and Undiagnosed Diseases Diagnostic Service (RUDDS) refers to a genomic diagnostic platform operating within the Western Australian Government clinical services delivered through Genetic Services of Western Australia (GSWA). GSWA has provided a state-wide service for clinical genetic care for 28 years and it serves a population of 2.5 million people across a geographical area of 2.5milion Km(2). Within this context, GSWA has established a clinically integrated genomic diagnostic platform in partnership with other public health system managers and service providers, including but not limited to the Office of Population Health Genomics, Diagnostic Genomics (PathWest Laboratories) and with executive level support from the Department of Health. Herein we describe report presents the components of this service that are most relevant to the heterogeneity of paediatric clinical genetic care. Briefly the platform : i) offers multiple options including non-genetic testing; monogenic and genomic (targeted in silico filtered and whole exome) analysis; and matchmaking; ii) is delivered in a patient-centric manner that is resonant with the patient journey, it has multiple points for entry, exit and re-entry to allow people access to information they can use, when they want to receive it; iii) is synchronous with precision phenotyping methods; iv) captures new knowledge, including multiple expert review; v) is integrated with current translational genomic research activities and best practice; and vi) is designed for flexibility for interactive generation of, and integration with, clinical research for diagnostics, community engagement, policy and models of care. The RUDDS has been established as part of routine clinical genetic services and is thus sustainable, equitably managed and seeks to translate new knowledge into efficient diagnostics and improved health for the whole community.

Comparison of computer systems and ranking criteria for automatic melanoma detection in dermoscopic images.

PubMed

Møllersen, Kajsa; Zortea, Maciel; Schopf, Thomas R; Kirchesch, Herbert; Godtliebsen, Fred

2017-01-01

Melanoma is the deadliest form of skin cancer, and early detection is crucial for patient survival. Computer systems can assist in melanoma detection, but are not widespread in clinical practice. In 2016, an open challenge in classification of dermoscopic images of skin lesions was announced. A training set of 900 images with corresponding class labels and semi-automatic/manual segmentation masks was released for the challenge. An independent test set of 379 images, of which 75 were of melanomas, was used to rank the participants. This article demonstrates the impact of ranking criteria, segmentation method and classifier, and highlights the clinical perspective. We compare five different measures for diagnostic accuracy by analysing the resulting ranking of the computer systems in the challenge. Choice of performance measure had great impact on the ranking. Systems that were ranked among the top three for one measure, dropped to the bottom half when changing performance measure. Nevus Doctor, a computer system previously developed by the authors, was used to participate in the challenge, and investigate the impact of segmentation and classifier. The diagnostic accuracy when using an automatic versus the semi-automatic/manual segmentation is investigated. The unexpected small impact of segmentation method suggests that improvements of the automatic segmentation method w.r.t. resemblance to semi-automatic/manual segmentation will not improve diagnostic accuracy substantially. A small set of similar classification algorithms are used to investigate the impact of classifier on the diagnostic accuracy. The variability in diagnostic accuracy for different classifier algorithms was larger than the variability for segmentation methods, and suggests a focus for future investigations. From a clinical perspective, the misclassification of a melanoma as benign has far greater cost than the misclassification of a benign lesion. For computer systems to have clinical impact, their performance should be ranked by a high-sensitivity measure.

Biomagnetism using SQUIDs: status and perspectives

NASA Astrophysics Data System (ADS)

Sternickel, Karsten; Braginski, Alex I.

2006-03-01

Biomagnetism involves the measurement and analysis of very weak local magnetic fields of living organisms and various organs in humans. Such fields can be of physiological origin or due to magnetic impurities or markers. This paper reviews existing and prospective applications of biomagnetism in clinical research and medical diagnostics. Currently, such applications require sensitive magnetic SQUID sensors and amplifiers. The practicality of biomagnetic methods depends especially on techniques for suppressing the dominant environmental electromagnetic noise, and on suitable nearly real-time data processing and interpretation methods. Of the many biomagnetic methods and applications, only the functional studies of the human brain (magnetoencephalography) and liver susceptometry are in clinical use, while functional diagnostics of the human heart (magnetocardiography) approaches the threshold of clinical acceptance. Particularly promising for the future is the ongoing research into low-field magnetic resonance anatomical imaging using SQUIDs.

Clinical evaluation and validation of laboratory methods for the diagnosis of Bordetella pertussis infection: Culture, polymerase chain reaction (PCR) and anti-pertussis toxin IgG serology (IgG-PT)

PubMed Central

Cassiday, Pamela K.; Pawloski, Lucia C.; Tatti, Kathleen M.; Martin, Monte D.; Briere, Elizabeth C.; Tondella, M. Lucia; Martin, Stacey W.

2018-01-01

Introduction The appropriate use of clinically accurate diagnostic tests is essential for the detection of pertussis, a poorly controlled vaccine-preventable disease. The purpose of this study was to estimate the sensitivity and specificity of different diagnostic criteria including culture, multi-target polymerase chain reaction (PCR), anti-pertussis toxin IgG (IgG-PT) serology, and the use of a clinical case definition. An additional objective was to describe the optimal timing of specimen collection for the various tests. Methods Clinical specimens were collected from patients with cough illness at seven locations across the United States between 2007 and 2011. Nasopharyngeal and blood specimens were collected from each patient during the enrollment visit. Patients who had been coughing for ≤ 2 weeks were asked to return in 2–4 weeks for collection of a second, convalescent blood specimen. Sensitivity and specificity of each diagnostic test were estimated using three methods—pertussis culture as the “gold standard,” composite reference standard analysis (CRS), and latent class analysis (LCA). Results Overall, 868 patients were enrolled and 13.6% were B. pertussis positive by at least one diagnostic test. In a sample of 545 participants with non-missing data on all four diagnostic criteria, culture was 64.0% sensitive, PCR was 90.6% sensitive, and both were 100% specific by LCA. CRS and LCA methods increased the sensitivity estimates for convalescent serology and the clinical case definition over the culture-based estimates. Culture and PCR were most sensitive when performed during the first two weeks of cough; serology was optimally sensitive after the second week of cough. Conclusions Timing of specimen collection in relation to onset of illness should be considered when ordering diagnostic tests for pertussis. Consideration should be given to including IgG-PT serology as a confirmatory test in the Council of State and Territorial Epidemiologists (CSTE) case definition for pertussis. PMID:29652945

Minimal methylation classifier (MIMIC): A novel method for derivation and rapid diagnostic detection of disease-associated DNA methylation signatures.

PubMed

Schwalbe, E C; Hicks, D; Rafiee, G; Bashton, M; Gohlke, H; Enshaei, A; Potluri, S; Matthiesen, J; Mather, M; Taleongpong, P; Chaston, R; Silmon, A; Curtis, A; Lindsey, J C; Crosier, S; Smith, A J; Goschzik, T; Doz, F; Rutkowski, S; Lannering, B; Pietsch, T; Bailey, S; Williamson, D; Clifford, S C

2017-10-18

Rapid and reliable detection of disease-associated DNA methylation patterns has major potential to advance molecular diagnostics and underpin research investigations. We describe the development and validation of minimal methylation classifier (MIMIC), combining CpG signature design from genome-wide datasets, multiplex-PCR and detection by single-base extension and MALDI-TOF mass spectrometry, in a novel method to assess multi-locus DNA methylation profiles within routine clinically-applicable assays. We illustrate the application of MIMIC to successfully identify the methylation-dependent diagnostic molecular subgroups of medulloblastoma (the most common malignant childhood brain tumour), using scant/low-quality samples remaining from the most recently completed pan-European medulloblastoma clinical trial, refractory to analysis by conventional genome-wide DNA methylation analysis. Using this approach, we identify critical DNA methylation patterns from previously inaccessible cohorts, and reveal novel survival differences between the medulloblastoma disease subgroups with significant potential for clinical exploitation.

[Clinical diagnostics of ADHD in preschool-aged children].

PubMed

Merkt, Julia; Petermann, Franz

2015-03-01

Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent psychiatric disorders in childhood and adolescence and has many negative consequences for both the child and the family. Early identification of children with ADHD would be helpful for the prevention of long-term consequences. This review appraises questionnaires and clinical interviews that can be used for the diagnosis of ADHD in preschool-aged children (3-5 years). We compare and discuss both German and international methods. The role of questionnaires and clinical interviews in the diagnostic process of ADHD is discussed.

Sporotrichosis: From KOH to Molecular Biology.

PubMed

Arenas, Roberto; Sánchez-Cardenas, Carlos D; Ramirez-Hobak, Lourdes; Ruíz Arriaga, Leon Felipe; Vega Memije, Ma Elisa

2018-05-23

Sporotrichosis is a cosmopolitan, chronic granulomatous mycosis, acquired by traumatic inoculation and caused by Sporothrix schenckii complex . Several methods of diagnostic are available, from KOH to molecular biology. In this review, we describe from the simplest (clinical diagnosis) to the most advanced diagnostic techniques (molecular biology).

Molecular imaging in neuroendocrine tumors: molecular uptake mechanisms and clinical results.

PubMed

Koopmans, Klaas P; Neels, Oliver N; Kema, Ido P; Elsinga, Philip H; Links, Thera P; de Vries, Elisabeth G E; Jager, Pieter L

2009-09-01

Neuroendocrine tumors can originate almost everywhere in the body and consist of a great variety of subtypes. This paper focuses on molecular imaging methods using nuclear medicine techniques in neuroendocrine tumors, coupling molecular uptake mechanisms of radiotracers with clinical results. A non-systematic review is presented on receptor based and metabolic imaging methods. Receptor-based imaging covers the molecular backgrounds of somatostatin, vaso-intestinal peptide (VIP), bombesin and cholecystokinin (CCK) receptors and their link with nuclear imaging. Imaging methods based on specific metabolic properties include meta-iodo-benzylguanide (MIBG) and dimercapto-sulphuric acid (DMSA-V) scintigraphy as well as more modern positron emission tomography (PET)-based methods using radio-labeled analogues of amino acids, glucose, dihydroxyphenylalanine (DOPA), dopamine and tryptophan. Diagnostic sensitivities are presented for each imaging method and for each neuroendocrine tumor subtype. Finally, a Forest plot analysis of diagnostic performance is presented for each tumor type in order to provide a comprehensive overview for clinical use.

Methodologic Guide for Evaluating Clinical Performance and Effect of Artificial Intelligence Technology for Medical Diagnosis and Prediction.

PubMed

Park, Seong Ho; Han, Kyunghwa

2018-03-01

The use of artificial intelligence in medicine is currently an issue of great interest, especially with regard to the diagnostic or predictive analysis of medical images. Adoption of an artificial intelligence tool in clinical practice requires careful confirmation of its clinical utility. Herein, the authors explain key methodology points involved in a clinical evaluation of artificial intelligence technology for use in medicine, especially high-dimensional or overparameterized diagnostic or predictive models in which artificial deep neural networks are used, mainly from the standpoints of clinical epidemiology and biostatistics. First, statistical methods for assessing the discrimination and calibration performances of a diagnostic or predictive model are summarized. Next, the effects of disease manifestation spectrum and disease prevalence on the performance results are explained, followed by a discussion of the difference between evaluating the performance with use of internal and external datasets, the importance of using an adequate external dataset obtained from a well-defined clinical cohort to avoid overestimating the clinical performance as a result of overfitting in high-dimensional or overparameterized classification model and spectrum bias, and the essentials for achieving a more robust clinical evaluation. Finally, the authors review the role of clinical trials and observational outcome studies for ultimate clinical verification of diagnostic or predictive artificial intelligence tools through patient outcomes, beyond performance metrics, and how to design such studies. © RSNA, 2018.

Development and evaluation of a culture-free microbiota profiling platform (MYcrobiota) for clinical diagnostics.

PubMed

Boers, Stefan A; Hiltemann, Saskia D; Stubbs, Andrew P; Jansen, Ruud; Hays, John P

2018-06-01

Microbiota profiling has the potential to greatly impact on routine clinical diagnostics by detecting DNA derived from live, fastidious, and dead bacterial cells present within clinical samples. Such results could potentially be used to benefit patients by influencing antibiotic prescribing practices or to generate new classical-based diagnostic methods, e.g., culture or PCR. However, technical flaws in 16S rRNA gene next-generation sequencing (NGS) protocols, together with the requirement for access to bioinformatics, currently hinder the introduction of microbiota analysis into clinical diagnostics. Here, we report on the development and evaluation of an "end-to-end" microbiota profiling platform (MYcrobiota), which combines our previously validated micelle PCR/NGS (micPCR/NGS) methodology with an easy-to-use, dedicated bioinformatics pipeline. The newly designed bioinformatics pipeline processes micPCR/NGS data automatically and summarizes the results in interactive, but simple web reports. In order to explore the utility of MYcrobiota in clinical diagnostics, 47 clinical samples (40 "damaged skin" samples and 7 synovial fluids) were investigated using routine bacterial culture as comparator. MYcrobiota confirmed the presence of bacterial DNA in 37/37 culture-positive samples and detected bacterial taxa in 2/10 culture-negative samples. Moreover, 36/38 potentially relevant aerobic bacterial taxa and 3/3 mixtures of anaerobic bacteria were identified using culture and MYcrobiota, with the sensitivity and specificity being 95%. Interestingly, the majority of the 448 bacterial taxa identified using MYcrobiota were not identified using culture, which could potentially have an impact on clinical decision-making. Taken together, the development of MYcrobiota is a promising step towards the introduction of microbiota analysis into clinical diagnostic laboratories.

Pediatric idiopathic intracranial hypertension - Is the fixed threshold value of elevated LP opening pressure set too high?

PubMed

Gerstl, Lucia; Schoppe, Nikola; Albers, Lucia; Ertl-Wagner, Birgit; Alperin, Noam; Ehrt, Oliver; Pomschar, Andreas; Landgraf, Mirjam N; Heinen, Florian

2017-11-01

Idiopathic intracranial hypertension (IIH) in children is a rare condition of unknown etiology and various clinical presentations. The primary aim of this study was to evaluate if our pediatric IIH study group fulfilled the revised diagnostic criteria for IIH published in 2013, particularly with regard to clinical presentation and threshold value of an elevated lumbar puncture opening pressure. Additionally we investigated the potential utilization of MR-based and fundoscopic methods of estimating intracranial pressure for improved diagnosis. Clinical data were collected retrospectively from twelve pediatric patients diagnosed with IIH between 2008 and 2012 and revised diagnostic criteria were applied. Comparison with non-invasive methods for measuring intracranial pressure, MRI-based measurement (MR-ICP) and venous ophthalmodynamometry was performed. Only four of the twelve children (33%) fulfilled the revised diagnostic criteria for a definite diagnosis of IIH. Regarding noninvasive methods, MR-ICP (n = 6) showed a significantly higher mean of intracranial pressure compared to a healthy age- and sex-matched control group (p = 0.0043). Venous ophthalmodynamometry (n = 4) showed comparable results to invasive lumbar puncture. The revised diagnostic criteria for IIH may be too strict especially in children without papilledema. MR-ICP and venous ophthalmodynamometry are promising complementary procedures for monitoring disease progression and response to treatment. Copyright © 2017 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

[Bronchopulmonary ACTH-producing tumors].

PubMed

Pikunov, M Iu; Kuznetsov, N S; Latkina, N V; Dobreva, E A; Remizov, O V

2014-01-01

Neuroendocrine tumors have the ability to produce the hormones and vasoactive peptides. Excess of these hormones leads to different symptoms and syndromes because of organs' injuries. Detection of ACTH origin by using of modern diagnostic methods is not always possible. Lungs and bronchi are one of the most frequent localization of ACTH-producing tumors. It is considered that carcinoids with bronchopulmonary localization like a benign tumors in the clinical course. But at the same time carcinoid tends to metastasize, so timely diagnostics and treatment improve quality of life significant and increase the life expectancy of patients. The modern state of diagnostics and surgical treatment problem of ACTH-producing tumors with bronchopulmonary localization is presented in the article. It was described the brief historical background, clinical symptoms, instrumental and biochemical methods of diagnosis. The principles of surgical treatment are presented in the article.

Automation of diagnostic genetic testing: mutation detection by cyclic minisequencing.

PubMed

Alagrund, Katariina; Orpana, Arto K

2014-01-01

The rising role of nucleic acid testing in clinical decision making is creating a need for efficient and automated diagnostic nucleic acid test platforms. Clinical use of nucleic acid testing sets demands for shorter turnaround times (TATs), lower production costs and robust, reliable methods that can easily adopt new test panels and is able to run rare tests in random access principle. Here we present a novel home-brew laboratory automation platform for diagnostic mutation testing. This platform is based on the cyclic minisequecing (cMS) and two color near-infrared (NIR) detection. Pipetting is automated using Tecan Freedom EVO pipetting robots and all assays are performed in 384-well micro plate format. The automation platform includes a data processing system, controlling all procedures, and automated patient result reporting to the hospital information system. We have found automated cMS a reliable, inexpensive and robust method for nucleic acid testing for a wide variety of diagnostic tests. The platform is currently in clinical use for over 80 mutations or polymorphisms. Additionally to tests performed from blood samples, the system performs also epigenetic test for the methylation of the MGMT gene promoter, and companion diagnostic tests for analysis of KRAS and BRAF gene mutations from formalin fixed and paraffin embedded tumor samples. Automation of genetic test reporting is found reliable and efficient decreasing the work load of academic personnel.

Epidemiology of angina pectoris: role of natural language processing of the medical record

PubMed Central

Pakhomov, Serguei; Hemingway, Harry; Weston, Susan A.; Jacobsen, Steven J.; Rodeheffer, Richard; Roger, Véronique L.

2007-01-01

Background The diagnosis of angina is challenging as it relies on symptom descriptions. Natural language processing (NLP) of the electronic medical record (EMR) can provide access to such information contained in free text that may not be fully captured by conventional diagnostic coding. Objective To test the hypothesis that NLP of the EMR improves angina pectoris (AP) ascertainment over diagnostic codes. Methods Billing records of in- and out-patients were searched for ICD-9 codes for AP, chronic ischemic heart disease and chest pain. EMR clinical reports were searched electronically for 50 specific non-negated natural language synonyms to these ICD-9 codes. The two methods were compared to a standardized assessment of angina by Rose questionnaire for three diagnostic levels: unspecified chest pain, exertional chest pain, and Rose angina. Results Compared to the Rose questionnaire, the true positive rate of EMR-NLP for unspecified chest pain was 62% (95%CI:55–67) vs. 51% (95%CI:44–58) for diagnostic codes (p<0.001). For exertional chest pain, the EMR-NLP true positive rate was 71% (95%CI:61–80) vs. 62% (95%CI:52–73) for diagnostic codes (p=0.10). Both approaches had 88% (95%CI:65–100) true positive rate for Rose angina. The EMR-NLP method consistently identified more patients with exertional chest pain over 28-month follow-up. Conclusion EMR-NLP method improves the detection of unspecified and exertional chest pain cases compared to diagnostic codes. These findings have implications for epidemiological and clinical studies of angina pectoris. PMID:17383310

Clinical Reasoning in the Real World Is Mediated by Bounded Rationality: Implications for Diagnostic Clinical Practice Guidelines

PubMed Central

Bonilauri Ferreira, Ana Paula Ribeiro; Ferreira, Rodrigo Fernando; Rajgor, Dimple; Shah, Jatin; Menezes, Andrea; Pietrobon, Ricardo

2010-01-01

Background Little is known about the reasoning mechanisms used by physicians in decision-making and how this compares to diagnostic clinical practice guidelines. We explored the clinical reasoning process in a real life environment. Method This is a qualitative study evaluating transcriptions of sixteen physicians' reasoning during appointments with patients, clinical discussions between specialists, and personal interviews with physicians affiliated to a hospital in Brazil. Results Four main themes were identified: simple and robust heuristics, extensive use of social environment rationality, attempts to prove diagnostic and therapeutic hypothesis while refuting potential contradictions using positive test strategy, and reaching the saturation point. Physicians constantly attempted to prove their initial hypothesis while trying to refute any contradictions. While social environment rationality was the main factor in the determination of all steps of the clinical reasoning process, factors such as referral letters and number of contradictions associated with the initial hypothesis had influence on physicians' confidence and determination of the threshold to reach a final decision. Discussion Physicians rely on simple heuristics associated with environmental factors. This model allows for robustness, simplicity, and cognitive energy saving. Since this model does not fit into current diagnostic clinical practice guidelines, we make some propositions to help its integration. PMID:20421920

Accuracy of clinical tests in the diagnosis of anterior cruciate ligament injury: a systematic review

PubMed Central

2014-01-01

Background Numerous clinical tests are used in the diagnosis of anterior cruciate ligament (ACL) injury but their accuracy is unclear. The purpose of this study is to evaluate the diagnostic accuracy of clinical tests for the diagnosis of ACL injury. Methods Study Design: Systematic review. The review protocol was registered through PROSPERO (CRD42012002069). Electronic databases (PubMed, MEDLINE, EMBASE, CINAHL) were searched up to 19th of June 2013 to identify diagnostic studies comparing the accuracy of clinical tests for ACL injury to an acceptable reference standard (arthroscopy, arthrotomy, or MRI). Risk of bias was appraised using the QUADAS-2 checklist. Index test accuracy was evaluated using a descriptive analysis of paired likelihood ratios and displayed as forest plots. Results A total of 285 full-text articles were assessed for eligibility, from which 14 studies were included in this review. Included studies were deemed to be clinically and statistically heterogeneous, so a meta-analysis was not performed. Nine clinical tests from the history (popping sound at time of injury, giving way, effusion, pain, ability to continue activity) and four from physical examination (anterior draw test, Lachman’s test, prone Lachman’s test and pivot shift test) were investigated for diagnostic accuracy. Inspection of positive and negative likelihood ratios indicated that none of the individual tests provide useful diagnostic information in a clinical setting. Most studies were at risk of bias and reported imprecise estimates of diagnostic accuracy. Conclusion Despite being widely used and accepted in clinical practice, the results of individual history items or physical tests do not meaningfully change the probability of ACL injury. In contrast combinations of tests have higher diagnostic accuracy; however the most accurate combination of clinical tests remains an area for future research. Clinical relevance Clinicians should be aware of the limitations associated with the use of clinical tests for diagnosis of ACL injury. PMID:25187877

Clinical application of high throughput molecular screening techniques for pharmacogenomics

PubMed Central

Wiita, Arun P; Schrijver, Iris

2011-01-01

Genetic analysis is one of the fastest-growing areas of clinical diagnostics. Fortunately, as our knowledge of clinically relevant genetic variants rapidly expands, so does our ability to detect these variants in patient samples. Increasing demand for genetic information may necessitate the use of high throughput diagnostic methods as part of clinically validated testing. Here we provide a general overview of our current and near-future abilities to perform large-scale genetic testing in the clinical laboratory. First we review in detail molecular methods used for high throughput mutation detection, including techniques able to monitor thousands of genetic variants for a single patient or to genotype a single genetic variant for thousands of patients simultaneously. These methods are analyzed in the context of pharmacogenomic testing in the clinical laboratories, with a focus on tests that are currently validated as well as those that hold strong promise for widespread clinical application in the near future. We further discuss the unique economic and clinical challenges posed by pharmacogenomic markers. Our ability to detect genetic variants frequently outstrips our ability to accurately interpret them in a clinical context, carrying implications both for test development and introduction into patient management algorithms. These complexities must be taken into account prior to the introduction of any pharmacogenomic biomarker into routine clinical testing. PMID:23226057

Noninvasive metabolic profiling for painless diagnosis of human diseases and disorders.

PubMed

Mal, Mainak

2016-06-01

Metabolic profiling provides a powerful diagnostic tool complementary to genomics and proteomics. The pain, discomfort and probable iatrogenic injury associated with invasive or minimally invasive diagnostic methods, render them unsuitable in terms of patient compliance and participation. Metabolic profiling of biomatrices like urine, breath, saliva, sweat and feces, which can be collected in a painless manner, could be used for noninvasive diagnosis. This review article covers the noninvasive metabolic profiling studies that have exhibited diagnostic potential for diseases and disorders. Their potential applications are evident in different forms of cancer, metabolic disorders, infectious diseases, neurodegenerative disorders, rheumatic diseases and pulmonary diseases. Large scale clinical validation of such diagnostic methods is necessary in future.

Noninvasive metabolic profiling for painless diagnosis of human diseases and disorders

PubMed Central

Mal, Mainak

2016-01-01

Metabolic profiling provides a powerful diagnostic tool complementary to genomics and proteomics. The pain, discomfort and probable iatrogenic injury associated with invasive or minimally invasive diagnostic methods, render them unsuitable in terms of patient compliance and participation. Metabolic profiling of biomatrices like urine, breath, saliva, sweat and feces, which can be collected in a painless manner, could be used for noninvasive diagnosis. This review article covers the noninvasive metabolic profiling studies that have exhibited diagnostic potential for diseases and disorders. Their potential applications are evident in different forms of cancer, metabolic disorders, infectious diseases, neurodegenerative disorders, rheumatic diseases and pulmonary diseases. Large scale clinical validation of such diagnostic methods is necessary in future. PMID:28031956

EVOLUTION OF ENVIRONMENTAL IMMUNOCHEMISTRY

EPA Science Inventory

Enzyme-linked immunosorbent assays (ELISAs), initially developed for clinical applications, have made a tremendous impact as clinical diagnostic indicators. Pesticide chemists became attracted to the potential of these sensitive and selective methods in the 1970s. Thus, beg...

A panel of clinical and neuropathological features of cerebrovascular disease through the novel neuroimaging methods

PubMed Central

Alves, Gilberto Sousa; de Carvalho, Luiza de Amorim; Sudo, Felipe Kenji; Briand, Lucas; Laks, Jerson; Engelhardt, Eliasz

2017-01-01

ABSTRACT. The last decade has witnessed substantial progress in acquiring diagnostic biomarkers for the diagnostic workup of cerebrovascular disease (CVD). Advanced neuroimaging methods not only provide a strategic contribution for the differential diagnosis of vascular dementia (VaD) and vascular cognitive impairment (VCI), but also help elucidate the pathophysiological mechanisms ultimately leading to small vessel disease (SVD) throughout its course. Objective: In this review, the novel imaging methods, both structural and metabolic, were summarized and their impact on the diagnostic workup of age-related CVD was analysed. Methods: An electronic search between January 2010 and 2017 was carried out on PubMed/MEDLINE, Institute for Scientific Information Web of Knowledge and EMBASE. Results: The use of full functional multimodality in simultaneous Magnetic Resonance (MR)/Positron emission tomography (PET) may potentially improve the clinical characterization of VCI-VaD; for structural imaging, MRI at 3.0 T enables higher-resolution scanning with greater imaging matrices, thinner slices and more detail on the anatomical structure of vascular lesions. Conclusion: Although the importance of most of these techniques in the clinical setting has yet to be recognized, there is great expectancy in achieving earlier and more refined therapeutic interventions for the effective management of VCI-VaD. PMID:29354214

A field study evaluation of Petrifilm™ plates as a 24-h rapid diagnostic test for clinical mastitis on a dairy farm.

PubMed

Mansion-de Vries, Elisabeth Maria; Knorr, Nicole; Paduch, Jan-Hendrik; Zinke, Claudia; Hoedemaker, Martina; Krömker, Volker

2014-03-01

Clinical mastitis is one of the most common and expensive diseases of dairy cattle. To make an informed treatment decision, it is important to know the causative pathogen. However, no detection of bacterial growth can be made in approximately 30% of all clinical cases of mastitis. Before selecting the treatment regimen, it is important to know whether the mastitis-causing pathogen (MCP) is Gram-positive or Gram-negative. The aim of this field study was to investigate whether using two 3M Petrifilm™ products on-farm (which conveys a higher degree of sample freshness but also bears a higher risk for contamination than working in a lab) as 24-h rapid diagnostic of clinical mastitis achieved results that were comparable to the conventional microbiological diagnostic method. AerobicCount (AC)-Petrifilm™ and ColiformCount (CC)-Petrifilm™ were used to identify the total bacterial counts and Gram-negative bacteria in samples from clinical mastitis cases, respectively. Missing growth on both plates was classified as no bacterial detection. Growth only on the AC-Petrifilm™ was assessed as Gram-positive, and growth on both Petrifilm™ plates was assessed as Gram-negative bacterial growth. Additionally, milk samples were analysed by conventional microbiological diagnostic method on aesculin blood agar as a reference method. Overall, 616 samples from clinical mastitis cases were analysed. Using the reference method, Gram-positive and Gram-negative bacteria, mixed bacterial growth, contaminated samples and yeast were determined in 32.6%, 20.0%, 2.5%, 14.1% and 1.1% of the samples, respectively. In 29.7% of the samples, microbiological growth could not be identified. Using the Petrifilm™ concept, bacterial growth was detected in 59% of the culture-negative samples. The sensitivity of the Petrifilm™ for Gram-positive and Gram-negative MCP was 85.2% and 89.9%, respectively. The specificity was 75.4% for Gram-positive and 88.4% for Gram-negative MCP. For the culture-negative samples, sensitivity was 41.0% and specificity was 91.0%. The results indicate that the Petrifilm™ concept is suitable for therapeutic decision-making at the farm level or in veterinary practice. As this concept does not allow any statement about the genus or species of microorganisms, relevant MCP should be assessed periodically at the herd level with conventional microbiological diagnostics. Copyright © 2014 Elsevier B.V. All rights reserved.

Current status and future perspectives on molecular and serological methods in diagnostic mycology.

PubMed

Lau, Anna; Chen, Sharon; Sleiman, Sue; Sorrell, Tania

2009-11-01

Invasive fungal infections are an important cause of infectious morbidity. Nonculture-based methods are increasingly used for rapid, accurate diagnosis to improve patient outcomes. New and existing DNA amplification platforms have high sensitivity and specificity for direct detection and identification of fungi in clinical specimens. Since laboratories are increasingly reliant on DNA sequencing for fungal identification, measures to improve sequence interpretation should support validation of reference isolates and quality control in public gene repositories. Novel technologies (e.g., isothermal and PNA FISH methods), platforms enabling high-throughput analyses (e.g., DNA microarrays and Luminex xMAP) and/or commercial PCR assays warrant further evaluation for routine diagnostic use. Notwithstanding the advantages of molecular tests, serological assays remain clinically useful for patient management. The serum Aspergillus galactomannan test has been incorporated into diagnostic algorithms of invasive aspergillosis. Both the galactomannan and the serum beta-D-glucan test have value for diagnosing infection and monitoring therapeutic response.

Molecular methods for pathogen and microbial community detection and characterization: current and potential application in diagnostic microbiology.

PubMed

Sibley, Christopher D; Peirano, Gisele; Church, Deirdre L

2012-04-01

Clinical microbiology laboratories worldwide have historically relied on phenotypic methods (i.e., culture and biochemical tests) for detection, identification and characterization of virulence traits (e.g., antibiotic resistance genes, toxins) of human pathogens. However, limitations to implementation of molecular methods for human infectious diseases testing are being rapidly overcome allowing for the clinical evaluation and implementation of diverse technologies with expanding diagnostic capabilities. The advantages and limitation of molecular techniques including real-time polymerase chain reaction, partial or whole genome sequencing, molecular typing, microarrays, broad-range PCR and multiplexing will be discussed. Finally, terminal restriction fragment length polymorphism (T-RFLP) and deep sequencing are introduced as technologies at the clinical interface with the potential to dramatically enhance our ability to diagnose infectious diseases and better define the epidemiology and microbial ecology of a wide range of complex infections. Copyright © 2012 Elsevier B.V. All rights reserved.

Emerging commercial molecular tests for the diagnosis of bloodstream infection.

PubMed

Mwaigwisya, Solomon; Assiri, Rasha Assad M; O'Grady, Justin

2015-05-01

Bloodstream infection (BSI) by microorganisms can lead to sepsis. This condition has a high mortality rate, which rises significantly with delays in initiation of appropriate antimicrobial treatment. Current culture methods for diagnosing BSI have long turnaround times and poor clinical sensitivity. While clinicians wait for culture diagnosis, patients are treated empirically, which can result in inappropriate treatment, undesirable side effects and contribute to drug resistance development. Molecular diagnostics assays that target pathogen DNA can identify pathogens and resistance markers within hours. Early diagnosis improves antibiotic stewardship and is associated with favorable clinical outcomes. Nonetheless, limitations of current molecular diagnostic methods are substantial. This article reviews recent commercially available molecular methods that use pathogen DNA to diagnose BSI, either by testing positive blood cultures or directly testing patient blood. We critically assess these tests and their application in clinical microbiology. A view of future directions in BSI diagnosis is also provided.

Non-invasive diagnostics of the maxillary and frontal sinuses based on diode laser gas spectroscopy.

PubMed

Lewander, Märta; Lindberg, Sven; Svensson, Tomas; Siemund, Roger; Svanberg, Katarina; Svanberg, Sune

2012-03-01

Suspected, but objectively absent, rhinosinusitis constitutes a major cause of visits to the doctor, high health care costs, and the over-prescription of antibiotics, contributing to the serious problem of resistant bacteria. This situation is largely due to a lack of reliable and widely applicable diagnostic methods. A novel method for the diagnosis of rhinosinusitis based on non-intrusive diode laser gas spectroscopy is presented. The technique is based on light absorption by free gas (oxygen and water vapour) inside the sinuses, and has the potential to be a complementary diagnostic tool in primary health care. The method was evaluated on 40 patients with suspected sinus problems, referred to the diagnostic radiology clinic for low-dose computed tomography (CT), which was used as the reference technique. The data obtained with the new laser-based method correlated well with the grading of opacification and ventilation using CT. The sensitivity and specificity were estimated to be 93% and 61%, respectively, for the maxillary sinuses, and 94% and 86%, respectively, for the frontal sinuses. Good reproducibility was shown. The laser-based technique presents real-time clinical data that correlate well to CT findings, while being non-intrusive and avoiding the use of ionizing radiation.

A clinical utility study of exome sequencing versus conventional genetic testing in pediatric neurology

PubMed Central

Vissers, Lisenka E.L.M.; van Nimwegen, Kirsten J.M.; Schieving, Jolanda H.; Kamsteeg, Erik-Jan; Kleefstra, Tjitske; Yntema, Helger G.; Pfundt, Rolph; van der Wilt, Gert Jan; Krabbenborg, Lotte; Brunner, Han G.; van der Burg, Simone; Grutters, Janneke; Veltman, Joris A.; Willemsen, Michèl A.A.P.

2017-01-01

Purpose: Implementation of novel genetic diagnostic tests is generally driven by technological advances because they promise shorter turnaround times and/or higher diagnostic yields. Other aspects, including impact on clinical management or cost-effectiveness, are often not assessed in detail prior to implementation. Methods: We studied the clinical utility of whole-exome sequencing (WES) in complex pediatric neurology in terms of diagnostic yield and costs. We analyzed 150 patients (and their parents) presenting with complex neurological disorders of suspected genetic origin. In a parallel study, all patients received both the standard diagnostic workup (e.g., cerebral imaging, muscle biopsies or lumbar punctures, and sequential gene-by-gene–based testing) and WES simultaneously. Results: Our unique study design allowed direct comparison of diagnostic yield of both trajectories and provided insight into the economic implications of implementing WES in this diagnostic trajectory. We showed that WES identified significantly more conclusive diagnoses (29.3%) than the standard care pathway (7.3%) without incurring higher costs. Exploratory analysis of WES as a first-tier diagnostic test indicates that WES may even be cost-saving, depending on the extent of other tests being omitted. Conclusion: Our data support such a use of WES in pediatric neurology for disorders of presumed genetic origin. Genet Med advance online publication 23 March 2017 PMID:28333917

Diagnostic indices for vertiginous diseases

PubMed Central

2010-01-01

Background Vertigo and dizziness are symptoms which are reported frequently in clinical practice. We aimed to develop diagnostic indices for four prevalent vertiginous diseases: benign paroxysmal positional vertigo (BPPV), Menière's disease (MD), vestibular migraine (VM), and phobic postural vertigo (PPV). Methods Based on a detailed questionnaire handed out to consecutive patients presenting for the first time in our dizziness clinic we preselected a set of seven questions with desirable diagnostic properties when compared with the final diagnosis after medical workup. Using exact logistic regression analysis diagnostic scores, each comprising of four to six items that can simply be added up, were built for each of the four diagnoses. Results Of 193 patients 131 questionnaires were left after excluding those with missing consent or data. Applying the suggested cut-off points, sensitivity and specificity were 87.5 and 93.5% for BPPV, 100 and 87.4% for MD, 92.3 and 83.7% for VM, 73.7 and 84.1% for PPV, respectively. By changing the cut-off points sensitivity and specificity can be adjusted to meet diagnostic needs. Conclusions The diagnostic indices showed promising diagnostic properties. Once further validated, they could provide an ease to use and yet flexible tool for screening vertigo in clinical practice and epidemiological research. PMID:20973968

Electronic-nose devices - Potential for noninvasive early disease-detection applications

Treesearch

Alphus Dan Wilson

2017-01-01

Significant progress in the development of portable electronic devices is showing considerable promise to facilitate clinical diagnostic processes. The increasing global trend of shifts in healthcare policies and priorities toward shortening and improving the effectiveness of diagnostic procedures by utilizing non-invasive methods should provide multiple benefits of...

Controlled Trial Using Computerized Feedback to Improve Physicians' Diagnostic Judgments.

ERIC Educational Resources Information Center

Poses, Roy M.; And Others

1992-01-01

A study involving 14 experienced physicians investigated the effectiveness of a computer program (providing statistical feedback to teach a clinical diagnostic rule that predicts the probability of streptococcal pharyngitis), in conjunction with traditional lecture and periodic disease-prevalence reports. Results suggest the integrated method is a…

The applicability of real-time PCR in the diagnostic of cutaneous leishmaniasis and parasite quantification for clinical management: Current status and perspectives.

PubMed

Moreira, Otacilio C; Yadon, Zaida E; Cupolillo, Elisa

2017-09-29

Cutaneous leishmaniasis (CL) is spread worldwide and is the most common manifestation of leishmaniasis. Diagnosis is performed by combining clinical and epidemiological features, and through the detection of Leishmania parasites (or DNA) in tissue specimens or trough parasite isolation in culture medium. Diagnosis of CL is challenging, reflecting the pleomorphic clinical manifestations of this disease. Skin lesions vary in severity, clinical appearance, and duration, and in some cases, they can be indistinguishable from lesions related to other diseases. Over the past few decades, PCR-based methods, including real-time PCR assays, have been developed for Leishmania detection, quantification and species identification, improving the molecular diagnosis of CL. This review provides an overview of many real-time PCR methods reported for the diagnostic evaluation of CL and some recommendations for the application of these methods for quantification purposes for clinical management and epidemiological studies. Furthermore, the use of real-time PCR for Leishmania species identification is also presented. The advantages of real-time PCR protocols are numerous, including increased sensitivity and specificity and simpler standardization of diagnostic procedures. However, despite the numerous assays described, there is still no consensus regarding the methods employed. Furthermore, the analytical and clinical validation of CL molecular diagnosis has not followed international guidelines so far. A consensus methodology comprising a DNA extraction protocol with an exogenous quality control and an internal reference to normalize parasite load is still needed. In addition, the analytical and clinical performance of any consensus methodology must be accurately assessed. This review shows that a standardization initiative is essential to guide researchers and clinical laboratories towards the achievement of a robust and reproducible methodology, which will permit further evaluation of parasite load as a surrogate marker of prognosis and monitoring of aetiological treatment, particularly in multi-centric observational studies and clinical trials. Copyright © 2017 Elsevier B.V. All rights reserved.

Computer-aided diagnostic strategy selection.

PubMed

Greenes, R A

1986-03-01

Determination of the optimal diagnostic work-up strategy for the patient is becoming a major concern for the practicing physician. Overlap of the indications for various diagnostic procedures, differences in their invasiveness or risk, and high costs have made physicians aware of the need to consider the choice of procedure carefully, as well as its relation to management actions available. In this article, the author discusses research approaches that aim toward development of formal decision analytic methods to allow the physician to determine optimal strategy; clinical algorithms or rules as guides to physician decisions; improved measures for characterizing the performance of diagnostic tests; educational tools for increasing the familiarity of physicians with the concepts underlying these measures and analytic procedures; and computer-based aids for facilitating the employment of these resources in actual clinical practice.

Application of laser Raman spectroscopy in concentration measurements of multiple analytes in human body fluids

NASA Astrophysics Data System (ADS)

Qu, Jianan Y.; Suria, David; Wilson, Brian C.

1998-05-01

The primary goal of these studies was to demonstrate that NIR Raman spectroscopy is feasible as a rapid and reagentless analytic method for clinical diagnostics. Raman spectra were collected on human serum and urine samples using a 785 nm excitation laser and a single-stage holographic spectrometer. A partial east squares method was used to predict the analyte concentrations of interest. The actual concentrations were determined by a standard clinical chemistry. The prediction accuracy of total protein, albumin, triglyceride and glucose in human sera ranged from 1.5 percent to 5 percent which is greatly acceptable for clinical diagnostics. The concentration measurements of acetaminophen, ethanol and codeine inhuman urine have demonstrated the potential of NIR Raman technology in screening of therapeutic drugs and substances of abuse.

Rapid phenotypic antimicrobial susceptibility testing using nanoliter arrays.

PubMed

Avesar, Jonathan; Rosenfeld, Dekel; Truman-Rosentsvit, Marianna; Ben-Arye, Tom; Geffen, Yuval; Bercovici, Moran; Levenberg, Shulamit

2017-07-18

Antibiotic resistance is a major global health concern that requires action across all sectors of society. In particular, to allow conservative and effective use of antibiotics clinical settings require better diagnostic tools that provide rapid determination of antimicrobial susceptibility. We present a method for rapid and scalable antimicrobial susceptibility testing using stationary nanoliter droplet arrays that is capable of delivering results in approximately half the time of conventional methods, allowing its results to be used the same working day. In addition, we present an algorithm for automated data analysis and a multiplexing system promoting practicality and translatability for clinical settings. We test the efficacy of our approach on numerous clinical isolates and demonstrate a 2-d reduction in diagnostic time when testing bacteria isolated directly from urine samples.

Diagnostics of breast cancer by analysis of spectra diffuse reflections

NASA Astrophysics Data System (ADS)

Kuzmina, Natalya V.; Plaksin, Fedor G.; Polovnikov, Eugeny S.

2001-05-01

The work is dedicated to problems of diagnostic oncologic diseases by a spectroscopic-optical method and is prolongation of long-term examinations held earlier by Vovk S.M, Naumov S.A. and Pushkarev S.V. The actual spectra of a diffuse reflection removed in vivo and in vitro are given, is angry- and good-quality neoplasms, healthy tissue and blood of breast and other organs. Problems of a clinical oncology are in a center of attention in medicine because the cases of disease malignant swellings increase, which is stipulated by an irregularity of present methods of diagnostic.

Acute kidney injury—an overview of diagnostic methods and clinical management

PubMed Central

Hertzberg, Daniel; Rydén, Linda; Pickering, John W.; Sartipy, Ulrik

2017-01-01

Abstract Acute kidney injury (AKI) is a common condition in multiple clinical settings. Patients with AKI are at an increased risk of death, over both the short and long term, and of accelerated renal impairment. As the condition has become more recognized and definitions more unified, there has been a rapid increase in studies examining AKI across many different clinical settings. This review focuses on the classification, diagnostic methods and clinical management that are available, or promising, for patients with AKI. Furthermore, preventive measures with fluids, acetylcysteine, statins and remote ischemic preconditioning, as well as when dialysis should be initiated in AKI patients are discussed. The classification of AKI includes both changes in serum creatinine concentrations and urine output. Currently, no kidney injury biomarkers are included in the classification of AKI, but proposals have been made to include them as independent diagnostic markers. Treatment of AKI is aimed at addressing the underlying causes of AKI, and at limiting damage and preventing progression. The key principles are: to treat the underlying disease, to optimize fluid balance and optimize hemodynamics, to treat electrolyte disturbances, to discontinue or dose-adjust nephrotoxic drugs and to dose-adjust drugs with renal elimination. PMID:28616210

Alternative Confidence Interval Methods Used in the Diagnostic Accuracy Studies

PubMed Central

Gülhan, Orekıcı Temel

2016-01-01

Background/Aim. It is necessary to decide whether the newly improved methods are better than the standard or reference test or not. To decide whether the new diagnostics test is better than the gold standard test/imperfect standard test, the differences of estimated sensitivity/specificity are calculated with the help of information obtained from samples. However, to generalize this value to the population, it should be given with the confidence intervals. The aim of this study is to evaluate the confidence interval methods developed for the differences between the two dependent sensitivity/specificity values on a clinical application. Materials and Methods. In this study, confidence interval methods like Asymptotic Intervals, Conditional Intervals, Unconditional Interval, Score Intervals, and Nonparametric Methods Based on Relative Effects Intervals are used. Besides, as clinical application, data used in diagnostics study by Dickel et al. (2010) has been taken as a sample. Results. The results belonging to the alternative confidence interval methods for Nickel Sulfate, Potassium Dichromate, and Lanolin Alcohol are given as a table. Conclusion. While preferring the confidence interval methods, the researchers have to consider whether the case to be compared is single ratio or dependent binary ratio differences, the correlation coefficient between the rates in two dependent ratios and the sample sizes. PMID:27478491

Alternative Confidence Interval Methods Used in the Diagnostic Accuracy Studies.

PubMed

Erdoğan, Semra; Gülhan, Orekıcı Temel

2016-01-01

Background/Aim. It is necessary to decide whether the newly improved methods are better than the standard or reference test or not. To decide whether the new diagnostics test is better than the gold standard test/imperfect standard test, the differences of estimated sensitivity/specificity are calculated with the help of information obtained from samples. However, to generalize this value to the population, it should be given with the confidence intervals. The aim of this study is to evaluate the confidence interval methods developed for the differences between the two dependent sensitivity/specificity values on a clinical application. Materials and Methods. In this study, confidence interval methods like Asymptotic Intervals, Conditional Intervals, Unconditional Interval, Score Intervals, and Nonparametric Methods Based on Relative Effects Intervals are used. Besides, as clinical application, data used in diagnostics study by Dickel et al. (2010) has been taken as a sample. Results. The results belonging to the alternative confidence interval methods for Nickel Sulfate, Potassium Dichromate, and Lanolin Alcohol are given as a table. Conclusion. While preferring the confidence interval methods, the researchers have to consider whether the case to be compared is single ratio or dependent binary ratio differences, the correlation coefficient between the rates in two dependent ratios and the sample sizes.

Photoacoustic spectroscopic differences between normal and malignant thyroid tissues

NASA Astrophysics Data System (ADS)

Li, Li; Xie, Wengming; Li, Hui

2012-12-01

The thyroid is one of the main endocrine glands of human body, which plays a crucial role in the body's metabolism. Thyroid cancer mortality ranks only second to ovarian cancer in endocrine cancer. Routine diagnostic methods of thyroid diseases in present clinic exist misdiagnosis and missed diagnosis to varying degrees. Those lead to miss the best period of cancer treatment--early. Photoacoustic spectroscopy technology is a new tool, which provides an effective and noninvasive way for biomedical materials research, being highly sensitive and without sample pretreatment. In this paper, we use photoacoustic spectroscopy technology (PAST) to detect the absorption spectrum between normal and malignant thyroid tissues. The result shows that the photoacoustic spectroscopy technology (PAST) could differentiate malignant thyroid tissue from normal thyroid tissue very well. This technique combined with routine diagnostic methods has the potential to increase the diagnostic accuracy in clinical thyroid cancer diagnosis.

Principles and applications of polymerase chain reaction in medical diagnostic fields: a review

PubMed Central

Valones, Marcela Agne Alves; Guimarães, Rafael Lima; Brandão, Lucas André Cavalcanti; de Souza, Paulo Roberto Eleutério; de Albuquerque Tavares Carvalho, Alessandra; Crovela, Sergio

2009-01-01

Recent developments in molecular methods have revolutionized the detection and characterization of microorganisms in a broad range of medical diagnostic fields, including virology, mycology, parasitology, microbiology and dentistry. Among these methods, Polymerase Chain Reaction (PCR) has generated great benefits and allowed scientific advancements. PCR is an excellent technique for the rapid detection of pathogens, including those difficult to culture. Along with conventional PCR techniques, Real-Time PCR has emerged as a technological innovation and is playing an ever-increasing role in clinical diagnostics and research laboratories. Due to its capacity to generate both qualitative and quantitative results, Real-Time PCR is considered a fast and accurate platform. The aim of the present literature review is to explore the clinical usefulness and potential of both conventional PCR and Real-Time PCR assays in diverse medical fields, addressing its main uses and advances. PMID:24031310

[Hereditary motor and sensory neuropathy type 4A].

PubMed

2010-01-01

The first in the Russian Federation clinical cases of patients with autosomal-recessive type of hereditary motor and sensory neuropathy, type 4A, (HMSN 4A) are presented. In all cases, the diagnosis has been verified using molecular-genetic methods (DNA diagnostics). An analysis of features of clinical manifestations was performed in patients, aged from 5 to 34 years, with different disease duration (from 3-to 29 years). Criteria of selection of patients for DNA diagnostics for searching mutations in the GDAP1 gene are specified.

Fluorescence analysis of ubiquinone and its application in quality control of medical supplies

NASA Astrophysics Data System (ADS)

Timofeeva, Elvira O.; Gorbunova, Elena V.; Chertov, Aleksandr N.

2017-02-01

The presence of antioxidant issues such as redox potential imbalance in human body is a very important question for modern clinical diagnostics. Implementation of fluorescence analysis into optical diagnostics of such wide distributed in a human body antioxidant as ubiquinone is one of the steps for development of the device with a view to clinical diagnostics of redox potential. Recording of fluorescence was carried out with spectrometer using UV irradiation source with thin band (max at 287 and 330 nm) as a background radiation. Concentrations of ubiquinone from 0.25 to 2.5 mmol/l in explored samples were used for investigation. Recording data was processed using correlation analysis and differential analytical technique. The fourth derivative spectrum of fluorescence spectrum provided the basis for a multicomponent analysis of the solutions. As a technique in clinical diagnostics fluorescence analysis with processing method including differential spectrophotometry, it is step forward towards redox potential calculation and quality control in pharmacy for better health care.

Diagnostic potential of optical coherence tomography in non-melanoma skin cancer: a clinical study

NASA Astrophysics Data System (ADS)

Mogensen, Mette; Thrane, Lars; Jørgensen, Thomas Martini; Jemec, Gregor B. E.

2007-07-01

Introduction: Non-melanoma skin cancer (NMSC) is the most prevalent cancer in the Western World. OCT has proved potential in assisting clinical diagnosis and perhaps reducing the need for biopsies in NMSC. As non-invasive treatment is increasingly used for NMSC patients with superficial lesions, the development of non-invasive diagnostic technologies is highly relevant. Methods: The aim of this cross-sectional clinical study, enrolling 100 NMSC patients and 20 healthy volunteers, is to investigate the diagnostic accuracy and applicability of OCT in NMSC diagnosis. Our OCT-system has been developed at Risoe National Laboratory, Denmark and offers ppolarization sensitive-OCT (PS-OCT) that may have additional advantaged as NMSC differ in content of birefringent collagens from normal skin. Results: Basal cell carcinomas (BCC) can in some cases be distinguished from normal skin in OCT-images, as normal skin exhibits a layered structure this layering is not present in BCC and sometimes not in actinic keratosis (AK). BCC lesions seem to be clearly less reflective than normal tissue. The predictive value of OCT in NMSC will be presented from a clinical point of view. Discussion: The earlier a skin cancer is diagnosed, the better the prognosis. Estimation of diagnostic accuracy and abilities of OCT in clinical studies of skin cancer patients is essential to establish the role and future set-ups for diagnostic OCT-systems.

A closer look at diagnosis in clinical dental practice: part 1. Reliability, validity, specificity and sensitivity of diagnostic procedures.

PubMed

Pretty, Iain A; Maupomé, Gerardo

2004-04-01

Dentists are involved in diagnosing disease in every aspect of their clinical practice. A range of tests, systems, guides and equipment--which can be generally referred to as diagnostic procedures--are available to aid in diagnostic decision making. In this era of evidence-based dentistry, and given the increasing demand for diagnostic accuracy and properly targeted health care, it is important to assess the value of such diagnostic procedures. Doing so allows dentists to weight appropriately the information these procedures supply, to purchase new equipment if it proves more reliable than existing equipment or even to discard a commonly used procedure if it is shown to be unreliable. This article, the first in a 6-part series, defines several concepts used to express the usefulness of diagnostic procedures, including reliability and validity, and describes some of their operating characteristics (statistical measures of performance), in particular, specificity and sensitivity. Subsequent articles in the series will discuss the value of diagnostic procedures used in daily dental practice and will compare today's most innovative procedures with established methods.

Diagnostic sensitivity and specificity of a participatory disease surveillance method for highly pathogenic avian influenza in household chicken flocks in Indonesia.

PubMed

Robyn, M; Priyono, W B; Kim, L M; Brum, E

2012-06-01

A study was conducted to assess the diagnostic sensitivity and specificity of a disease surveillance method for diagnosis of highly pathogenic avian influenza (HPAI) outbreaks in household chicken flocks used by participatory disease surveillance (PDS) teams in Yogyakarta Province, Indonesia. The Government of Indonesia, in partnership with the Food and Agriculture Organization of the United Nations, has implemented a PDS method for the detection of HPAI outbreaks in poultry since 2006. The PDS method in Indonesia utilizes both a clinical case definition (CD) and the result of a commercial rapid antigen test kit Yogyakarta 55611, to diagnose HPAI outbreaks, primarily in backyard chicken flocks. The following diagnostic sensitivities and specificities were obtained relative to real-time reverse transcription-PCR as the gold standard diagnostic test: 1) 89% sensitivity (CI95: 75%-97%) and 96% specificity (CI95: 89%-99%) for the PDS CD alone; 2) 86% sensitivity (CI95: 71%-95%) and 99% specificity (CI95: 94%-100%) for the rapid antigen test alone; and 3) 84% sensitivity (CI95: 68%-94%) and 100% specificity (CI95: 96%-100%) for the PDS CD result combined with the rapid antigen test result. Based on these results, HPAI outbreaks in extensively raised household chickens can be diagnosed with sufficient sensitivity and specificity using the PDS method as implemented in Indonesia. Subject to further field evaluation, data from this study suggest that the diagnostic sensitivity of the PDS method may be improved by expanding the PDS CD to include more possible clinical presentations of HPAI and by increasing the number of rapid antigen tests to three different birds with HPAI-compatible signs of same flock.

panelcn.MOPS: Copy-number detection in targeted NGS panel data for clinical diagnostics.

PubMed

Povysil, Gundula; Tzika, Antigoni; Vogt, Julia; Haunschmid, Verena; Messiaen, Ludwine; Zschocke, Johannes; Klambauer, Günter; Hochreiter, Sepp; Wimmer, Katharina

2017-07-01

Targeted next-generation-sequencing (NGS) panels have largely replaced Sanger sequencing in clinical diagnostics. They allow for the detection of copy-number variations (CNVs) in addition to single-nucleotide variants and small insertions/deletions. However, existing computational CNV detection methods have shortcomings regarding accuracy, quality control (QC), incidental findings, and user-friendliness. We developed panelcn.MOPS, a novel pipeline for detecting CNVs in targeted NGS panel data. Using data from 180 samples, we compared panelcn.MOPS with five state-of-the-art methods. With panelcn.MOPS leading the field, most methods achieved comparably high accuracy. panelcn.MOPS reliably detected CNVs ranging in size from part of a region of interest (ROI), to whole genes, which may comprise all ROIs investigated in a given sample. The latter is enabled by analyzing reads from all ROIs of the panel, but presenting results exclusively for user-selected genes, thus avoiding incidental findings. Additionally, panelcn.MOPS offers QC criteria not only for samples, but also for individual ROIs within a sample, which increases the confidence in called CNVs. panelcn.MOPS is freely available both as R package and standalone software with graphical user interface that is easy to use for clinical geneticists without any programming experience. panelcn.MOPS combines high sensitivity and specificity with user-friendliness rendering it highly suitable for routine clinical diagnostics. © 2017 The Authors. Human Mutation published by Wiley Periodicals, Inc.

panelcn.MOPS: Copy‐number detection in targeted NGS panel data for clinical diagnostics

PubMed Central

Povysil, Gundula; Tzika, Antigoni; Vogt, Julia; Haunschmid, Verena; Messiaen, Ludwine; Zschocke, Johannes; Klambauer, Günter; Wimmer, Katharina

2017-01-01

Abstract Targeted next‐generation‐sequencing (NGS) panels have largely replaced Sanger sequencing in clinical diagnostics. They allow for the detection of copy‐number variations (CNVs) in addition to single‐nucleotide variants and small insertions/deletions. However, existing computational CNV detection methods have shortcomings regarding accuracy, quality control (QC), incidental findings, and user‐friendliness. We developed panelcn.MOPS, a novel pipeline for detecting CNVs in targeted NGS panel data. Using data from 180 samples, we compared panelcn.MOPS with five state‐of‐the‐art methods. With panelcn.MOPS leading the field, most methods achieved comparably high accuracy. panelcn.MOPS reliably detected CNVs ranging in size from part of a region of interest (ROI), to whole genes, which may comprise all ROIs investigated in a given sample. The latter is enabled by analyzing reads from all ROIs of the panel, but presenting results exclusively for user‐selected genes, thus avoiding incidental findings. Additionally, panelcn.MOPS offers QC criteria not only for samples, but also for individual ROIs within a sample, which increases the confidence in called CNVs. panelcn.MOPS is freely available both as R package and standalone software with graphical user interface that is easy to use for clinical geneticists without any programming experience. panelcn.MOPS combines high sensitivity and specificity with user‐friendliness rendering it highly suitable for routine clinical diagnostics. PMID:28449315

Imaging of neurodegenerative cognitive and behavioral disorders: practical considerations for dementia clinical practice.

PubMed

Atri, Alireza

2016-01-01

This chapter reviews clinical applications and imaging findings useful in medical practice relating to neurodegenerative cognitive/dementing disorders. The preponderance of evidence and consensus guidelines support an essential role of multitiered neuroimaging in the evaluation and management of neurodegenerative cognitive/dementia syndrome that range in severity from mild impairments to frank dementia. Additionally, imaging features are incorporated in updated clinical and research diagnostic criteria for most dementias, including Alzheimer's disease (AD), Dementia with Lewy bodies (DLB), Frontotemporal Lobar Degenerations/Frontotemporal Dementia (FTD), and Vascular Cognitive Impairment (VCI). Best clinical practices dictate that structural imaging, preferably with magnetic resonance imaging (MRI) when possible and computed tomography when not, be obtained as a first-tier approach during the course of a thorough clinical evaluation to improve diagnostic confidence and assess for nonneurodegenerative treatable conditions that may cause or substantially contribute to cognitive/behavioral symptoms or which may dictate a substantial change in management. These conditions include less common structural (e.g., mass lesions such as tumors and hematomas; normal-pressure hydrocephalus), inflammatory, autoimmune and infectious conditions, and more common comorbid contributing conditions (e.g., vascular cerebral injury causing leukoaraiosis, infarcts, or microhemorrhages) that can produce a mixed dementia syndrome. When, after appropriate clinical, cognitive/neuropsychologic, and structural neuroimaging assessment, a dementia specialist remains in doubt regarding etiology and appropriate management, second-tier imaging with molecular methods, preferably with fluorodexoyglucose positron emission tomography (PET) (or single-photon emission computed tomography if PET is unavailable) can provide more diagnostic specificity (e.g., help differentiate between atypical AD and FTD as the etiology for a frontal/dysexecutive syndrome). The potential clinical utility of other promising methods, whether already approved for use (e.g., amyloid PET) or as yet only used in research (e.g., tau PET, functional MRI, diffusor tensor imaging), remains to be proven for widespread use in community practice. However, these constitute unreimbursed third-tier options that merit further study for clinical and cost-effective utility. In the future, combination use of imaging methods will likely improve diagnostic accuracy. © 2016 Elsevier B.V. All rights reserved.

[Clinical applications of molecular imaging methods for patients with ischemic stroke].

PubMed

Yamauchi, Hiroshi; Fukuyama, Hidenao

2007-02-01

Several molecular imaging methods have been developed to visualize pathophysiology of cerebral ischemia in humans in vivo. PET and SPECT with specific ligands have been mainly used as diagnostic tools for the clinical usage of molecular imaging in patients with ischemic stroke. Recently, cellular MR imaging with specific contrast agents has been developed to visualize targeted cells in human stroke patients. This article reviews the current status in the clinical applications of those molecular imaging methods for patients with ischemic stroke.

Performance Evaluation of an Automated ELISA System for Alzheimer's Disease Detection in Clinical Routine.

PubMed

Chiasserini, Davide; Biscetti, Leonardo; Farotti, Lucia; Eusebi, Paolo; Salvadori, Nicola; Lisetti, Viviana; Baschieri, Francesca; Chipi, Elena; Frattini, Giulia; Stoops, Erik; Vanderstichele, Hugo; Calabresi, Paolo; Parnetti, Lucilla

2016-07-22

The variability of Alzheimer's disease (AD) cerebrospinal fluid (CSF) biomarkers undermines their full-fledged introduction into routine diagnostics and clinical trials. Automation may help to increase precision and decrease operator errors, eventually improving the diagnostic performance. Here we evaluated three new CSF immunoassays, EUROIMMUNtrademark amyloid-β 1-40 (Aβ1-40), amyloid-β 1-42 (Aβ1-42), and total tau (t-tau), in combination with automated analysis of the samples. The CSF biomarkers were measured in a cohort consisting of AD patients (n = 28), mild cognitive impairment (MCI, n = 77), and neurological controls (OND, n = 35). MCI patients were evaluated yearly and cognitive functions were assessed by Mini-Mental State Examination. The patients clinically diagnosed with AD and MCI were classified according to the CSF biomarkers profile following NIA-AA criteria and the Erlangen score. Technical evaluation of the immunoassays was performed together with the calculation of their diagnostic performance. Furthermore, the results for EUROIMMUN Aβ1-42 and t-tau were compared to standard immunoassay methods (INNOTESTtrademark). EUROIMMUN assays for Aβ1-42 and t-tau correlated with INNOTEST (r = 0.83, p < 0.001 for both) and allowed a similar interpretation of the CSF profiles. The Aβ1-42/Aβ1-40 ratio measured with EUROIMMUN was the best parameter for AD detection and improved the diagnostic accuracy of Aβ1-42 (area under the curve = 0.93). In MCI patients, the Aβ1-42/Aβ1-40 ratio was associated with cognitive decline and clinical progression to AD.The diagnostic performance of the EUROIMMUN assays with automation is comparable to other currently used methods. The variability of the method and the value of the Aβ1-42/Aβ1-40 ratio in AD diagnosis need to be validated in large multi-center studies.

An Item Response Theory Modeling of Alcohol and Marijuana Dependences: A National Drug Abuse Treatment Clinical Trials Network Study*

PubMed Central

Wu, Li-Tzy; Pan, Jeng-Jong; Blazer, Dan G.; Tai, Betty; Stitzer, Maxine L.; Brooner, Robert K.; Woody, George E.; Patkar, Ashwin A.; Blaine, Jack D.

2009-01-01

Objective: The aim of this study was to examine psychometric properties of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), diagnostics criteria for alcohol and marijuana dependences among 462 alcohol users and 311 marijuana users enrolled in two multisite trials of the National Drug Abuse Treatment Clinical Trials Network. Method: Diagnostic questions were assessed by the DSM-IV checklist. Data were analyzed by the item response theory and the multiple indicators–multiple causes method procedures. Results: Criterion symptoms of alcohol and marijuana dependences exhibited a high level of internal consistency. All individual symptoms showed good discrimination in distinguishing alcohol or marijuana users between high and low severity levels of the continuum. In both groups, “withdrawal” appeared to measure the most severe symptom of the dependence continuum. There was little evidence of measurement nonequivalence in assessing symptoms of dependence by gender, age, race/ethnicity, and educational level. Conclusions: These findings highlight the clinical utility of the DSM-IV checklist in assessing alcohol- and marijuana-dependence syndromes among treatment-seeking substance users. PMID:19371493

Real-time caries diagnostics by optical PNC method

NASA Astrophysics Data System (ADS)

Masychev, Victor I.; Alexandrov, Michail T.

2000-11-01

The results of hard tooth tissues research by the optical PNC- method in experimental and clinical conditions are presented. In the experiment under 90 test-sample of tooth slices with thickness about 1mm (enamel, dentine and cement) were researched. The results of the experiment were processed by the method of correlation analyze. Clinical researches were executed on teeth of 210 patients. The regions of tooth tissue diseases with initial, moderate and deep caries were investigated. Spectral characteristics of intact and pathologically changed tooth tissues are presented and their peculiar features are discussed. The results the optical PNC-method application while processing tooth carious cavities are presented in order to estimate efficiency of the mechanical and antiseptic processing of teeth. It is revealed that the PNC-method can be sued as for differential diagnostics of a degree dental carious stage, as for estimating of carefulness of tooth cavity processing before filling.

Express diagnostics of intact and pathological dental hard tissues by optical PNC method

NASA Astrophysics Data System (ADS)

Masychev, Victor I.; Alexandrov, Michail T.

2000-03-01

The results of hard tooth tissues research by the optical PNC- method in experimental and clinical conditions are presented. In the experiment under 90 test-sample of tooth slices with thickness about 1 mm (enamel, dentine and cement) were researched. The results of the experiment were processed by the method of correlation analyze. Clinical researches were executed on teeth of 210 patients. The regions of tooth tissue diseases with initial, moderate and deep caries were investigated. Spectral characteristics of intact and pathologically changed tooth tissues are presented and their peculiar features are discussed. The results the optical PNC- method application while processing tooth carious cavities are presented in order to estimate efficiency of the mechanical and antiseptic processing of teeth. It is revealed that the PNC-method can be used as for differential diagnostics of a degree dental carious stage, as for estimating of carefulness of tooth cavity processing before filling.

Teaching Techniques in Clinical Chemistry.

ERIC Educational Resources Information Center

Wilson, Diane

This master's thesis presents several instructional methods and techniques developed for each of eleven topics or subject areas in clinical chemistry: carbohydrate metabolism, lipid metabolism, diagnostic enzymology, endocrinology, toxicology, quality control, electrolytes, acid base balance, hepatic function, nonprotein nitrogenous compounds, and…

Diagnostic accuracy of stress perfusion CMR in comparison with quantitative coronary angiography: fully quantitative, semiquantitative, and qualitative assessment.

PubMed

Mordini, Federico E; Haddad, Tariq; Hsu, Li-Yueh; Kellman, Peter; Lowrey, Tracy B; Aletras, Anthony H; Bandettini, W Patricia; Arai, Andrew E

2014-01-01

This study's primary objective was to determine the sensitivity, specificity, and accuracy of fully quantitative stress perfusion cardiac magnetic resonance (CMR) versus a reference standard of quantitative coronary angiography. We hypothesized that fully quantitative analysis of stress perfusion CMR would have high diagnostic accuracy for identifying significant coronary artery stenosis and exceed the accuracy of semiquantitative measures of perfusion and qualitative interpretation. Relatively few studies apply fully quantitative CMR perfusion measures to patients with coronary disease and comparisons to semiquantitative and qualitative methods are limited. Dual bolus dipyridamole stress perfusion CMR exams were performed in 67 patients with clinical indications for assessment of myocardial ischemia. Stress perfusion images alone were analyzed with a fully quantitative perfusion (QP) method and 3 semiquantitative methods including contrast enhancement ratio, upslope index, and upslope integral. Comprehensive exams (cine imaging, stress/rest perfusion, late gadolinium enhancement) were analyzed qualitatively with 2 methods including the Duke algorithm and standard clinical interpretation. A 70% or greater stenosis by quantitative coronary angiography was considered abnormal. The optimum diagnostic threshold for QP determined by receiver-operating characteristic curve occurred when endocardial flow decreased to <50% of mean epicardial flow, which yielded a sensitivity of 87% and specificity of 93%. The area under the curve for QP was 92%, which was superior to semiquantitative methods: contrast enhancement ratio: 78%; upslope index: 82%; and upslope integral: 75% (p = 0.011, p = 0.019, p = 0.004 vs. QP, respectively). Area under the curve for QP was also superior to qualitative methods: Duke algorithm: 70%; and clinical interpretation: 78% (p < 0.001 and p < 0.001 vs. QP, respectively). Fully quantitative stress perfusion CMR has high diagnostic accuracy for detecting obstructive coronary artery disease. QP outperforms semiquantitative measures of perfusion and qualitative methods that incorporate a combination of cine, perfusion, and late gadolinium enhancement imaging. These findings suggest a potential clinical role for quantitative stress perfusion CMR. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Optimization and validation of sample preparation for metagenomic sequencing of viruses in clinical samples.

PubMed

Lewandowska, Dagmara W; Zagordi, Osvaldo; Geissberger, Fabienne-Desirée; Kufner, Verena; Schmutz, Stefan; Böni, Jürg; Metzner, Karin J; Trkola, Alexandra; Huber, Michael

2017-08-08

Sequence-specific PCR is the most common approach for virus identification in diagnostic laboratories. However, as specific PCR only detects pre-defined targets, novel virus strains or viruses not included in routine test panels will be missed. Recently, advances in high-throughput sequencing allow for virus-sequence-independent identification of entire virus populations in clinical samples, yet standardized protocols are needed to allow broad application in clinical diagnostics. Here, we describe a comprehensive sample preparation protocol for high-throughput metagenomic virus sequencing using random amplification of total nucleic acids from clinical samples. In order to optimize metagenomic sequencing for application in virus diagnostics, we tested different enrichment and amplification procedures on plasma samples spiked with RNA and DNA viruses. A protocol including filtration, nuclease digestion, and random amplification of RNA and DNA in separate reactions provided the best results, allowing reliable recovery of viral genomes and a good correlation of the relative number of sequencing reads with the virus input. We further validated our method by sequencing a multiplexed viral pathogen reagent containing a range of human viruses from different virus families. Our method proved successful in detecting the majority of the included viruses with high read numbers and compared well to other protocols in the field validated against the same reference reagent. Our sequencing protocol does work not only with plasma but also with other clinical samples such as urine and throat swabs. The workflow for virus metagenomic sequencing that we established proved successful in detecting a variety of viruses in different clinical samples. Our protocol supplements existing virus-specific detection strategies providing opportunities to identify atypical and novel viruses commonly not accounted for in routine diagnostic panels.

Music therapy with disorders of consciousness: current evidence and emergent evidence-based practice.

PubMed

Magee, Wendy L; O'Kelly, Julian

2015-03-01

Patients with prolonged disorders of consciousness (PDOC) stemming from acquired brain injury present one of the most challenging clinical populations in neurological rehabilitation. Because of the complex clinical presentation of PDOC patients, treatment teams are confronted with many medicolegal, ethical, philosophical, moral, and religious issues in day-to-day care. Accurate diagnosis is of central concern, relying on creative approaches from skilled clinical professionals using combined behavioral and neurophysiological measures. This paper presents the latest evidence for using music as a diagnostic tool with PDOC, including recent developments in music therapy interventions and measurement. We outline standardized clinical protocols and behavioral measures to produce diagnostic outcomes and examine recent research illustrating a range of benefits of music-based methods at behavioral, cardiorespiratory, and cortical levels using video, electrocardiography, and electroencephalography methods. These latest developments are discussed in the context of evidence-based practice in rehabilitation with clinical populations. © 2014 New York Academy of Sciences.

Towards advanced OCT clinical applications

NASA Astrophysics Data System (ADS)

Kirillin, Mikhail; Panteleeva, Olga; Agrba, Pavel; Pasukhin, Mikhail; Sergeeva, Ekaterina; Plankina, Elena; Dudenkova, Varvara; Gubarkova, Ekaterina; Kiseleva, Elena; Gladkova, Natalia; Shakhova, Natalia; Vitkin, Alex

2015-07-01

In this paper we report on our recent achievement in application of conventional and cross-polarization OCT (CP OCT) modalities for in vivo clinical diagnostics in different medical areas including gynecology, dermatology, and stomatology. In gynecology, CP OCT was employed for diagnosing fallopian tubes and cervix; in dermatology OCT for monitoring of treatment of psoriasis, scleroderma and atopic dermatitis; and in stomatology for diagnosis of oral diseases. For all considered application, we propose and develop different image processing methods which enhance the diagnostic value of the technique. In particular, we use histogram analysis, Fourier analysis and neural networks, thus calculating different tissue characteristics as revealed by OCT's polarization evolution. These approaches enable improved OCT image quantification and increase its resultant diagnostic accuracy.

Evaluating a mobile application for improving clinical laboratory test ordering and diagnosis.

PubMed

Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep

2018-04-20

Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.

Proband-only medical exome sequencing as a cost-effective first-tier genetic diagnostic test for patients without prior molecular tests and clinical diagnosis in a developing country: the China experience.

PubMed

Hu, Xuyun; Li, Niu; Xu, Yufei; Li, Guoqiang; Yu, Tingting; Yao, Ru-En; Fu, Lijun; Wang, Jiwen; Yin, Lei; Yin, Yong; Wang, Ying; Jin, Xingming; Wang, Xiumin; Wang, Jian; Shen, Yiping

2017-11-02

PurposeTo evaluate the performance of proband-only medical exome sequencing (POMES) as a cost-effective first-tier diagnostic test for pediatric patients with unselected conditions.MethodsA total of 1,323 patients were tested by POMES, which targeted 2,742 known disease-causing genes. Clinical relevant variants were Sanger-confirmed in probands and parents. We assessed the diagnostic validity and clinical utility of POMES by means of a survey questionnaire.ResultsPOMES, ordered by 136 physicians, identified 512 pathogenic or likely pathogenic variants associated with over 200 conditions. The overall diagnostic rate was 28.8%, ranging from 10% in neonatal intensive care unit patients to over 35% in pediatric intensive care unit patients. The test results had an impact on the management of the 45.1% of patients for whom there were positive findings. The average turnaround time was 57 days; the cost was $360/case.ConclusionWe adopted a relatively efficient and cost-effective approach in China for the molecular diagnosis of pediatric patients with suspected genetic conditions. While training for clinical geneticists and other specialists is lagging behind in China POMES is serving as a diagnostic equalizer for patients who do not normally receive extensive clinical evaluation and clinical diagnosis prior to testing. This Chinese experience should be applicable to other developing countries that are lacking clinical, financial, and personnel resources.GENETICS in MEDICINE advance online publication, 2 November 2017; doi:10.1038/gim.2017.195.

Teaching clinical reasoning: case-based and coached.

PubMed

Kassirer, Jerome P

2010-07-01

Optimal medical care is critically dependent on clinicians' skills to make the right diagnosis and to recommend the most appropriate therapy, and acquiring such reasoning skills is a key requirement at every level of medical education. Teaching clinical reasoning is grounded in several fundamental principles of educational theory. Adult learning theory posits that learning is best accomplished by repeated, deliberate exposure to real cases, that case examples should be selected for their reflection of multiple aspects of clinical reasoning, and that the participation of a coach augments the value of an educational experience. The theory proposes that memory of clinical medicine and clinical reasoning strategies is enhanced when errors in information, judgment, and reasoning are immediately pointed out and discussed. Rather than using cases artificially constructed from memory, real cases are greatly preferred because they often reflect the false leads, the polymorphisms of actual clinical material, and the misleading test results encountered in everyday practice. These concepts foster the teaching and learning of the diagnostic process, the complex trade-offs between the benefits and risks of diagnostic tests and treatments, and cognitive errors in clinical reasoning. The teaching of clinical reasoning need not and should not be delayed until students gain a full understanding of anatomy and pathophysiology. Concepts such as hypothesis generation, pattern recognition, context formulation, diagnostic test interpretation, differential diagnosis, and diagnostic verification provide both the language and the methods of clinical problem solving. Expertise is attainable even though the precise mechanisms of achieving it are not known.

Improved detection of Burkholderia pseudomallei from non-blood clinical specimens using enrichment culture and PCR: narrowing diagnostic gap in resource-constrained settings.

PubMed

Tellapragada, Chaitanya; Shaw, Tushar; D'Souza, Annet; Eshwara, Vandana Kalwaje; Mukhopadhyay, Chiranjay

2017-07-01

To evaluate the diagnostic utility of enrichment culture and PCR for improved case detection rates of non-bacteraemic form of melioidosis in limited resource settings. Clinical specimens (n = 525) obtained from patients presenting at a tertiary care hospital of South India with clinical symptoms suggestive of community-acquired pneumonia, lower respiratory tract infections, superficial or internal abscesses, chronic skin ulcers and bone or joint infections were tested for the presence of Burkholderia pseudomallei using conventional culture (CC), enrichment culture (EC) and PCR. Sensitivity, specificity, positive and negative predictive values of CC and PCR were initially deduced using EC as the gold standard method. Further, diagnostic accuracies of all the three methods were analysed using Bayesian latent class modelling (BLCM). Detection rates of B. pseudomallei using CC, EC and PCR were 3.8%, 5.3% and 6%, respectively. Diagnostic sensitivities and specificities of CC and PCR were 71.4, 98.4% and 100 and 99.4%, respectively in comparison with EC as the gold standard test. With Bayesian latent class modelling, EC and PCR demonstrated sensitivities of 98.7 and 99.3%, respectively, while CC showed a sensitivity of 70.3% for detection of B. pseudomallei. An increase of 1.6% (95% CI: 1.08-4.32%) in the case detection rate of melioidosis was observed in the study population when EC and/or PCR were used in adjunct to the conventional culture technique. Our study findings underscore the diagnostic superiority of enrichment culture and/or PCR over conventional microbiological culture for improved case detection of melioidosis from non-blood clinical specimens. © 2017 John Wiley & Sons Ltd.

Evaluation of the Ortho-Clinical Diagnostics Vitros ECi Anti-HCV test: comparison with three other methods.

PubMed

Watterson, Jeannette M; Stallcup, Paulina; Escamilla, David; Chernay, Patrick; Reyes, Alfred; Trevino, Sylvia C

2007-01-01

After observing a high incidence of low positive hepatitis C virus (HCV) antibody screens by the Ortho-Clinical Vitros ECi test (Orthoclinical Diagnostics, Raritan, NJ), we compared results against those obtained using another chemiluminescent analyzer, as well as two U.S. Food and Drug Administration (FDA)-approved confirmatory methodologies. To ascertain the true anti-HCV status of samples deemed low-positive by the Ortho-Clinical Vitros ECi test, we tested samples using the ADVIA Centaur HCV screen test (Siemens Medical Solutions Diagnostics), the Chiron recombinant immunoblot assay (RIBA) test (Chiron Corp., Emeryville, CA), and the Roche COBAS Amplicor HCV qualitative test (Roche Diagnostics, Indianapolis, IN) in a series of studies. Of 94 specimens positive by Vitros ECi, 19% were observed to be negative by Centaur. A separate study of 91 samples with signal-to-cutoff (s/co) values less than 8.0 showed that all but one was negative for HCV ribonucleic acid (RNA). In comparison with RIBA, 100% (77) samples positive by the Vitros ECi test with s/co values less than 12.0 were negative or indeterminate by RIBA. A final study comparing all four methods side-by-side showed 63% disagreement by Centaur for Vitros ECi low-positive samples, 75% disagreement by RIBA, and 97% disagreement by polymerase chain reaction (PCR). In conclusion, the Ortho-Clinical Vitros ECi Anti-HCV test yields a high rate of false-positive results in the low s/co range in our patient population. (c) 2007 Wiley-Liss, Inc.

Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD—‘Assessing QbTest Utility in ADHD’ (AQUA): a randomised controlled trial

PubMed Central

Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris

2014-01-01

Introduction The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current ‘gold standard’ ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. Methods and analysis This multisite randomised controlled trial will recruit young people (aged 6–17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. Ethics and dissemination The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval. Trial registration number NCT02209116. PMID:25448628

42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Payment for a new clinical diagnostic laboratory... SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.508 Payment for a new clinical diagnostic laboratory test. For a new clinical diagnostic laboratory test that is assigned a new or...

42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Payment for a new clinical diagnostic laboratory... SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.508 Payment for a new clinical diagnostic laboratory test. For a new clinical diagnostic laboratory test that is assigned a new or...

Molecular diagnostic methods for invasive fungal disease: the horizon draws nearer?

PubMed

Halliday, C L; Kidd, S E; Sorrell, T C; Chen, S C-A

2015-04-01

Rapid, accurate diagnostic laboratory tests are needed to improve clinical outcomes of invasive fungal disease (IFD). Traditional direct microscopy, culture and histological techniques constitute the 'gold standard' against which newer tests are judged. Molecular diagnostic methods, whether broad-range or fungal-specific, have great potential to enhance sensitivity and speed of IFD diagnosis, but have varying specificities. The use of PCR-based assays, DNA sequencing, and other molecular methods including those incorporating proteomic approaches such as matrix-assisted laser desorption ionisation-time of flight mass spectroscopy (MALDI-TOF MS) have shown promising results. These are used mainly to complement conventional methods since they require standardisation before widespread implementation can be recommended. None are incorporated into diagnostic criteria for defining IFD. Commercial assays may assist standardisation. This review provides an update of molecular-based diagnostic approaches applicable to biological specimens and fungal cultures in microbiology laboratories. We focus on the most common pathogens, Candida and Aspergillus, and the mucormycetes. The position of molecular-based approaches in the detection of azole and echinocandin antifungal resistance is also discussed.

Clinical Decision Rules for Diagnostic Imaging in the Emergency Department: A Research Agenda.

PubMed

Finnerty, Nathan M; Rodriguez, Robert M; Carpenter, Christopher R; Sun, Benjamin C; Theyyunni, Nik; Ohle, Robert; Dodd, Kenneth W; Schoenfeld, Elizabeth M; Elm, Kendra D; Kline, Jeffrey A; Holmes, James F; Kuppermann, Nathan

2015-12-01

Major gaps persist in the development, validation, and implementation of clinical decision rules (CDRs) for diagnostic imaging. The objective of this working group and article was to generate a consensus-based research agenda for the development and implementation of CDRs for diagnostic imaging in the emergency department (ED). The authors followed consensus methodology, as outlined by the journal Academic Emergency Medicine (AEM), combining literature review, electronic surveys, telephonic communications, and a modified nominal group technique. Final discussions occurred in person at the 2015 AEM consensus conference. A research agenda was developed, prioritizing the following questions: 1) what are the optimal methods to justify the derivation and validation of diagnostic imaging CDRs, 2) what level of evidence is required before disseminating CDRs for widespread implementation, 3) what defines a successful CDR, 4) how should investigators best compare CDRs to clinical judgment, and 5) what disease states are amenable (and highest priority) to development of CDRs for diagnostic imaging in the ED? The concepts discussed herein demonstrate the need for further research on CDR development and implementation regarding diagnostic imaging in the ED. Addressing this research agenda should have direct applicability to patients, clinicians, and health care systems. © 2015 by the Society for Academic Emergency Medicine.

Fully Automated Quantification of the Striatal Uptake Ratio of [99mTc]-TRODAT with SPECT Imaging: Evaluation of the Diagnostic Performance in Parkinson's Disease and the Temporal Regression of Striatal Tracer Uptake

PubMed Central

Fang, Yu-Hua Dean; Chiu, Shao-Chieh; Lu, Chin-Song; Weng, Yi-Hsin

2015-01-01

Purpose. We aimed at improving the existing methods for the fully automatic quantification of striatal uptake of [99mTc]-TRODAT with SPECT imaging. Procedures. A normal [99mTc]-TRODAT template was first formed based on 28 healthy controls. Images from PD patients (n = 365) and nPD subjects (28 healthy controls and 33 essential tremor patients) were spatially normalized to the normal template. We performed an inverse transform on the predefined striatal and reference volumes of interest (VOIs) and applied the transformed VOIs to the original image data to calculate the striatal-to-reference ratio (SRR). The diagnostic performance of the SRR was determined through receiver operating characteristic (ROC) analysis. Results. The SRR measured with our new and automatic method demonstrated excellent diagnostic performance with 92% sensitivity, 90% specificity, 92% accuracy, and an area under the curve (AUC) of 0.94. For the evaluation of the mean SRR and the clinical duration, a quadratic function fit the data with R 2 = 0.84. Conclusions. We developed and validated a fully automatic method for the quantification of the SRR in a large study sample. This method has an excellent diagnostic performance and exhibits a strong correlation between the mean SRR and the clinical duration in PD patients. PMID:26366413

Fully Automated Quantification of the Striatal Uptake Ratio of [(99m)Tc]-TRODAT with SPECT Imaging: Evaluation of the Diagnostic Performance in Parkinson's Disease and the Temporal Regression of Striatal Tracer Uptake.

PubMed

Fang, Yu-Hua Dean; Chiu, Shao-Chieh; Lu, Chin-Song; Yen, Tzu-Chen; Weng, Yi-Hsin

2015-01-01

We aimed at improving the existing methods for the fully automatic quantification of striatal uptake of [(99m)Tc]-TRODAT with SPECT imaging. A normal [(99m)Tc]-TRODAT template was first formed based on 28 healthy controls. Images from PD patients (n = 365) and nPD subjects (28 healthy controls and 33 essential tremor patients) were spatially normalized to the normal template. We performed an inverse transform on the predefined striatal and reference volumes of interest (VOIs) and applied the transformed VOIs to the original image data to calculate the striatal-to-reference ratio (SRR). The diagnostic performance of the SRR was determined through receiver operating characteristic (ROC) analysis. The SRR measured with our new and automatic method demonstrated excellent diagnostic performance with 92% sensitivity, 90% specificity, 92% accuracy, and an area under the curve (AUC) of 0.94. For the evaluation of the mean SRR and the clinical duration, a quadratic function fit the data with R (2) = 0.84. We developed and validated a fully automatic method for the quantification of the SRR in a large study sample. This method has an excellent diagnostic performance and exhibits a strong correlation between the mean SRR and the clinical duration in PD patients.

Towards a Standard Psychometric Diagnostic Interview for Subjects at Ultra High Risk of Psychosis: CAARMS versus SIPS

PubMed Central

Fusar-Poli, P.; Cappucciati, M.; Rutigliano, G.; Lee, T. Y.; Beverly, Q.; Bonoldi, I.; Lelli, J.; Kaar, S. J.; Gago, E.; Rocchetti, M.; Patel, R.; Bhavsar, V.; Tognin, S.; Badger, S.; Calem, M.; Lim, K.; Kwon, J. S.; Perez, J.; McGuire, P.

2016-01-01

Background. Several psychometric instruments are available for the diagnostic interview of subjects at ultra high risk (UHR) of psychosis. Their diagnostic comparability is unknown. Methods. All referrals to the OASIS (London) or CAMEO (Cambridgeshire) UHR services from May 13 to Dec 14 were interviewed for a UHR state using both the CAARMS 12/2006 and the SIPS 5.0. Percent overall agreement, kappa, the McNemar-Bowker χ 2 test, equipercentile methods, and residual analyses were used to investigate diagnostic outcomes and symptoms severity or frequency. A conversion algorithm (CONVERT) was validated in an independent UHR sample from the Seoul Youth Clinic (Seoul). Results. There was overall substantial CAARMS-versus-SIPS agreement in the identification of UHR subjects (n = 212, percent overall agreement = 86%; kappa = 0.781, 95% CI from 0.684 to 0.878; McNemar-Bowker test = 0.069), with the exception of the brief limited intermittent psychotic symptoms (BLIPS) subgroup. Equipercentile-linking table linked symptoms severity and frequency across the CAARMS and SIPS. The conversion algorithm was validated in 93 UHR subjects, showing excellent diagnostic accuracy (CAARMS to SIPS: ROC area 0.929; SIPS to CAARMS: ROC area 0.903). Conclusions. This study provides initial comparability data between CAARMS and SIPS and will inform ongoing multicentre studies and clinical guidelines for the UHR psychometric diagnostic interview. PMID:27314005

Rapid detection of D-Dimers with mLabs® whole blood method for venous thromboembolism exclusion. Comparison with Vidas® D-Dimers assay.

PubMed

Gerotziafas, Grigoris T; Ray, Patrick; Gkalea, Vasiliki; Benzarti, Ahlem; Khaterchi, Amir; Cast, Claire; Pernet, Julie; Lefkou, Eleftheria; Elalamy, Ismail

2016-12-01

Easy to use point of care assays for D-Dimers measurement in whole blood from patients with clinical suspicion of venous thromboembolism (VTE) will facilitate the diagnostic strategy in the Emergency Department (ED) setting. We prospectively evaluated the diagnostic performance of the point-of-care mLabs® Whole Blood D-Dimers test and we compared it with the Vidas® D-Dimers assay. As part of the diagnostic algorithm applied in patients with clinical suspicion of VTE, the VIDAS® D-Dimers Test was prescribed by the emergency physician in charge. The mLabs® Whole Blood D-Dimers Test was used on the same samples. All patients had undergone exploration with the recommended imaging techniques for VTE diagnosis. Both assays were performed, on 99 emergency patients (mean age was 65 years) with clinical suspicion of VTE. In 3% of patients, VTE was documented with a reference imaging technique. The Bland and Altman test showed significant agreement between the two methods. Both assays showed equal sensitivity and negative predictive value for VTE. The mLabs whole blood assay is a promising point of care method for measurement of D-Dimers and exclusion of VTE diagnosis in the emergency setting which should be validated in a larger prospective study.

[Clinical decision making: Fostering critical thinking in the nursing diagnostic process through case studies].

PubMed

Müller-Staub, Maria; Stuker-Studer, Ursula

2006-10-01

Case studies, based on actual patients' situations, provide a method of clinical decision making to foster critical thinking in nurses. This paper describes the method and process of group case studies applied in continuous education settings. This method bases on Balints' case supervision and was further developed and combined with the nursing diagnostic process. A case study contains different phases: Pre-phase, selection phase, case delineation and case work. The case provider narratively tells the situation of a patient. This allows the group to analyze and cluster signs and symptoms, to state nursing diagnoses and to derive nursing interventions. Results of the case study are validated by applying the theoretical background and critical appraisal of the case provider. Learning effects of the case studies were evaluated by means of qualitative questionnaires and analyzed according to Mayring. Findings revealed the following categories: a) Patients' problems are perceived in a patient centred way, accurate nursing diagnoses are stated and effective nursing interventions implemented. b) Professional nursing tasks are more purposefully perceived and named more precise. c) Professional nursing relationship, communication and respectful behaviour with patients were perceived in differentiated ways. The theoretical framework is described in the paper "Clinical decision making and critical thinking in the nursing diagnostic process". (Müller-Staub, 2006).

Wound Healing Finally Enters the Age of Molecular Diagnostic Medicine

PubMed Central

Tatum, Owatha L.; Dowd, Scot E.

2012-01-01

Background Many wounds are difficult to heal because of the large, complex community of microbes present within the wound. The Problem Classical laboratory culture methods do not provide an accurate picture of the microbial interactions or representation of microorganisms within a wound. There is an inherent bias in diagnosis based upon classical culture stemming from the ability of certain organisms to thrive in culture while others are underrepresented or fail to be identified in culture altogether. Chronic wounds also contain polymicrobial infections existing as a cooperative community that is resistant to antibiotic therapy. Basic/Clinical Science Advances New methods in molecular diagnostic medicine allow the identification of nearly all organisms present in a wound irrespective of the ability of these organisms to be grown in culture. Advances in DNA analyses allow absolute identification of microorganisms from very small clinical specimens. These new methods also provide a quantitative representation of all microorganisms contributing to these polymicrobial infections. Clinical Care Relevance Technological advances in laboratory diagnostics can significantly shorten the time required to heal chronic wounds. Identification of the genetic signatures of organisms present within a wound allows clinicians to identify and treat the primary organisms responsible for nonhealing wounds. Conclusion Advanced genetic technologies targeting the specific needs of wound care patients are now accessible to all wound care clinicians. PMID:24527290

Rapid testing for malaria in settings where microscopy is available and peripheral clinics where only presumptive treatment is available: a randomised controlled trial in Ghana.

PubMed

Ansah, Evelyn K; Narh-Bana, Solomon; Epokor, Michael; Akanpigbiam, Samson; Quartey, Alberta Amu; Gyapong, John; Whitty, Christopher J M

2010-03-05

To test in West Africa the impact of rapid diagnostic tests on the prescription of antimalarials and antibiotics both where microscopy is used for the diagnosis of malaria and in clinical (peripheral) settings that rely on clinical diagnosis. Randomised, controlled, open label clinical trial. Four clinics in the rural Dangme West district of southern Ghana, one in which microscopy is used for diagnosis of malaria ("microscopy setting") and three where microscopy is not available and diagnosis of malaria is made on the basis of clinical symptoms ("clinical setting"). Patients with suspected malaria. Interventions Patients were randomly assigned to either a rapid diagnostic test or the current diagnostic method at the clinic (microscopy or clinical diagnosis). A blood sample for a research microscopy slide was taken for all patients. The primary outcome was the prescription of antimalarials to patients of any age whose double read research slide was negative for malaria. The major secondary outcomes were the correct prescription of antimalarials, the impact of test results on antibiotic prescription, and the correct prescription of antimalarials in children under 5 years. Of the 9236 patients screened, 3452 were randomised in the clinical setting and 3811 in the microscopy setting. Follow-up to 28 days was 97.6% (7088/7263). In the microscopy setting, 722 (51.6%) of the 1400 patients with negative research slides in the rapid diagnostic test arm were treated for malaria compared with 764 (55.0%) of the 1389 patients in the microscopy arm (adjusted odds ratio 0.87, 95% CI 0.71 to 1.1; P=0.16). In the clinical setting, 578 (53.9%) of the 1072 patients in the rapid diagnostic test arm with negative research slides were treated for malaria compared with 982 (90.1%) of the 1090 patients with negative slides in the clinical diagnosis arm (odds ratio 0.12, 95% CI 0.04 to 0.38; P=0.001). The use of rapid diagnostic tests led to better targeting of antimalarials and antibiotics in the clinical but not the microscopy setting, in both children and adults. There were no deaths in children under 5 years at 28 days follow-up in either arm. Where microscopy already exists, introducing rapid diagnostic tests had limited impact on prescriber behaviour. In settings where microscopy was not available, however, using rapid diagnostic tests led to a significant reduction in the overprescription of antimalarials, without any evidence of clinical harm, and to better targeting of antibiotics. Trial registration ClinicalTrials.gov NCT00493922.

Multiple sclerosis - etiology and diagnostic potential.

PubMed

Kamińska, Joanna; Koper, Olga M; Piechal, Kinga; Kemona, Halina

2017-06-30

Multiple sclerosis (MS) is a chronic inflammatory and demyelinating disease of autoimmune originate. The main agents responsible for the MS development include exogenous, environmental, and genetic factors. MS is characterized by multifocal and temporally scattered central nervous system (CNS) damage which lead to the axonal damage. Among clinical courses of MS it can be distinguish relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPSM), primary progressive multiple sclerosis (PPMS), and progressive-relapsing multiple sclerosis (RPMS). Depending on the severity of signs and symptoms MS can be described as benign MS or malignant MS. MS diagnosis is based on McDonald's diagnostic criteria, which link clinical manifestation with characteristic lesions demonstrated by magnetic resonance imaging (MRI), cerebrospinal fluid (CSF) analysis, and visual evoked potentials. Among CSF laboratory tests used to the MS diagnosis are applied: Tibbling & Link IgG index, reinbegrams, and CSF isoelectrofocusing for oligoclonal bands detection. It should be emphasized, that despite huge progress regarding MS as well as the availability of different diagnostics methods this disease is still a diagnostic challenge. It may result from fact that MS has diverse clinical course and there is a lack of single test, which would be of appropriate diagnostic sensitivity and specificity for quick and accurate diagnosis.

Clinical Problem Analysis (CPA): A Systematic Approach To Teaching Complex Medical Problem Solving.

ERIC Educational Resources Information Center

Custers, Eugene J. F. M.; Robbe, Peter F. De Vries; Stuyt, Paul M. J.

2000-01-01

Discusses clinical problem analysis (CPA) in medical education, an approach to solving complex clinical problems. Outlines the five step CPA model and examines the value of CPA's content-independent (methodical) approach. Argues that teaching students to use CPA will enable them to avoid common diagnostic reasoning errors and pitfalls. Compares…

The Diagnostic Validity and Reliability of an Internet-Based Clinical Assessment Program for Mental Disorders

PubMed Central

Klein, Britt; Meyer, Denny; Austin, David William; Abbott, Jo-Anne M

2015-01-01

Background Internet-based assessment has the potential to assist with the diagnosis of mental health disorders and overcome the barriers associated with traditional services (eg, cost, stigma, distance). Further to existing online screening programs available, there is an opportunity to deliver more comprehensive and accurate diagnostic tools to supplement the assessment and treatment of mental health disorders. Objective The aim was to evaluate the diagnostic criterion validity and test-retest reliability of the electronic Psychological Assessment System (e-PASS), an online, self-report, multidisorder, clinical assessment and referral system. Methods Participants were 616 adults residing in Australia, recruited online, and representing prospective e-PASS users. Following e-PASS completion, 158 participants underwent a telephone-administered structured clinical interview and 39 participants repeated the e-PASS within 25 days of initial completion. Results With structured clinical interview results serving as the gold standard, diagnostic agreement with the e-PASS varied considerably from fair (eg, generalized anxiety disorder: κ=.37) to strong (eg, panic disorder: κ=.62). Although the e-PASS’ sensitivity also varied (0.43-0.86) the specificity was generally high (0.68-1.00). The e-PASS sensitivity generally improved when reducing the e-PASS threshold to a subclinical result. Test-retest reliability ranged from moderate (eg, specific phobia: κ=.54) to substantial (eg, bulimia nervosa: κ=.87). Conclusions The e-PASS produces reliable diagnostic results and performs generally well in excluding mental disorders, although at the expense of sensitivity. For screening purposes, the e-PASS subclinical result generally appears better than a clinical result as a diagnostic indicator. Further development and evaluation is needed to support the use of online diagnostic assessment programs for mental disorders. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN121611000704998; http://www.anzctr.org.au/trial_view.aspx?ID=336143 (Archived by WebCite at http://www.webcitation.org/618r3wvOG). PMID:26392066

Diagnostic communication in the memory clinic: a conversation analytic perspective

PubMed Central

Peel, Elizabeth

2015-01-01

Objectives: Whether and how patients should be told their dementia diagnosis, has been an area of much debate. While there is now recognition that early diagnosis is important for dementia care little research has looked at how dementia-related diagnostic information is actually verbally communicated. The limited previous research suggests that the absence of explicit terminology (e.g., use of the term Alzheimer's) is problematic. This paper interrogates this assumption through a conversation analysis of British naturalistic memory clinic interaction. Method: This paper is based on video-recordings of communication within a UK memory clinic. Appointments with 29 patients and accompanying persons were recorded, and the corpus was repeatedly listened to, in conjunction with the transcripts in order to identify the segments of talk where there was an action hearable as diagnostic delivery, that is where the clinician is evaluating the patient's condition. Results: Using a conversation analytic approach this analysis suggests that diagnostic communication, which is sensitive and responsive to the patient and their carers, is not predicated on the presence or absence of particular lexical choices. There is inherent complexity regarding dementia diagnosis, especially in the ‘early stages’, which is produced through and reflected in diagnostic talk in clinical encounters. Conclusion: In the context of continuity of dementia care, diagnostic information is communicated in a way that conforms to intersubjective norms of minimizing catastrophic reactions in medical communication, and is sensitive to problems associated with ‘insight’ in terms of delivery and receipt or non-receipt of diagnosis. PMID:25647148

Is there any evidence for the validity of diagnostic criteria used for accommodative and nonstrabismic binocular dysfunctions?

PubMed Central

Cacho-Martínez, Pilar; García-Muñoz, Ángel; Ruiz-Cantero, María Teresa

2013-01-01

Purpose To analyze the diagnostic criteria used in the scientific literature published in the past 25 years for accommodative and nonstrabismic binocular dysfunctions and to explore if the epidemiological analysis of diagnostic validity has been used to propose which clinical criteria should be used for diagnostic purposes. Methods We carried out a systematic review of papers on accommodative and non-strabic binocular disorders published from 1986 to 2012 analysing the MEDLINE, CINAHL, PsycINFO and FRANCIS databases. We admitted original articles about diagnosis of these anomalies in any population. We identified 839 articles and 12 studies were included. The quality of included articles was assessed using the QUADAS-2 tool. Results The review shows a wide range of clinical signs and cut-off points between authors. Only 3 studies (regarding accommodative anomalies) assessed diagnostic accuracy of clinical signs. Their results suggest using the accommodative amplitude and monocular accommodative facility for diagnosing accommodative insufficiency and a high positive relative accommodation for accommodative excess. The remaining 9 articles did not analyze diagnostic accuracy, assessing a diagnosis with the criteria the authors considered. We also found differences between studies in the way of considering patients’ symptomatology. 3 studies of 12 analyzed, performed a validation of a symptom survey used for convergence insufficiency. Conclusions Scientific literature reveals differences between authors according to diagnostic criteria for accommodative and nonstrabismic binocular dysfunctions. Diagnostic accuracy studies show that there is only certain evidence for accommodative conditions. For binocular anomalies there is only evidence about a validated questionnaire for convergence insufficiency with no data of diagnostic accuracy. PMID:24646897

Clinical Data as an Adjunct to Ultrasound Reduces the False-Negative Malignancy Rate in BI-RADS 3 Breast Lesions

PubMed Central

Ackermann, S.; Schoenenberger, C.-A.; Zanetti-Dällenbach, R.

2016-01-01

Purpose: Ultrasound (US) is a well-established diagnostic procedure for breast examination. We investigated the malignancy rate in solid breast lesions according to their BI-RADS classification with a particular focus on false-negative BI-RADS 3 lesions. We examined whether patient history and clinical findings could provide additional information that would help determine further diagnostic steps in breast lesions. Materials and Methods: We conducted a retrospective study by exploring US BI-RADS in 1469 breast lesions of 1201 patients who underwent minimally invasive breast biopsy (MIBB) from January 2002 to December 2011. Results: The overall sensitivity and specificity of BI-RADS classification was 97.4% and 66.4%, respectively, with a positive (PPV) and negative predictive value (NPV) of 65% and 98%, respectively. In 506 BI-RADS 3 lesions, histology revealed 15 malignancies (2.4% malignancy rate), which corresponds to a false-negative rate (FNR) of 2.6%. Clinical evaluation and patient requests critically influenced the further diagnostic procedure, thereby prevailing over the recommendation given by the BI-RADS 3 classification. Conclusion: Clinical criteria including age, family and personal history, clinical examination, mammography and patient choice ensure adequate diagnostic procedures such as short-term follow-up or MIBB in patients with lesions classified as US-BI-RADS 3. PMID:27689181

Outcomes of Diagnostic Exome Sequencing in Patients With Diagnosed or Suspected Autism Spectrum Disorders.

PubMed

Rossi, Mari; El-Khechen, Dima; Black, Mary Helen; Farwell Hagman, Kelly D; Tang, Sha; Powis, Zöe

2017-05-01

Exome sequencing has recently been proved to be a successful diagnostic method for complex neurodevelopmental disorders. However, the diagnostic yield of exome sequencing for autism spectrum disorders has not been extensively evaluated in large cohorts to date. We performed diagnostic exome sequencing in a cohort of 163 individuals with autism spectrum disorder (66.3%) or autistic features (33.7%). The diagnostic yield observed in patients in our cohort was 25.8% (42 of 163) for positive or likely positive findings in characterized disease genes, while a candidate genetic etiology was reported for an additional 3.3% (4 of 120) of patients. Among the positive findings in the patients with autism spectrum disorder or autistic features, 61.9% were the result of de novo mutations. Patients presenting with psychiatric conditions or ataxia or paraplegia in addition to autism spectrum disorder or autistic features were significantly more likely to receive positive results compared with patients without these clinical features (95.6% vs 27.1%, P < 0.0001; 83.3% vs 21.2%, P < 0.0001, respectively). The majority of the positive findings were in recently identified autism spectrum disorder genes, supporting the importance of diagnostic exome sequencing for patients with autism spectrum disorder or autistic features as the causative genes might evade traditional sequential or panel testing. These results suggest that diagnostic exome sequencing would be an efficient primary diagnostic method for patients with autism spectrum disorders or autistic features. Moreover, our data may aid clinicians to better determine which subset of patients with autism spectrum disorder with additional clinical features would benefit the most from diagnostic exome sequencing. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Sensitivity and Specificity of Proposed "DSM-5" Diagnostic Criteria for Autism Spectrum Disorder

ERIC Educational Resources Information Center

McPartland, James C.; Reichow, Brian; Volkmar, Fred R.

2012-01-01

Objective: This study evaluated the potential impact of proposed "DSM-5" diagnostic criteria for autism spectrum disorder (ASD). Method: The study focused on a sample of 933 participants evaluated during the "DSM-IV" field trial; 657 carried a clinical diagnosis of an ASD, and 276 were diagnosed with a non-autistic disorder. Sensitivity and…

Recent developments in the management of invasive fungal infections in patients with oncohematological diseases.

PubMed

Ruhnke, Markus; Schwartz, Stefan

2016-12-01

Patients with hematological cancer have a high risk of invasive fungal diseases (IFDs). These infections are mostly life threatening and an early diagnosis and initiation of appropriate antifungal therapy are essential for the clinical outcome. Most commonly, Aspergillus and Candida species are involved. However, other non- Aspergillus molds are increasingly be identified in cases of documented IFDs. Important risk factors are long lasting granulocytopenia with neutrophil counts below 500/μl for more than 10 days or graft- versus -host disease resulting from allogeneic stem-cell transplantation. For definite diagnosis of IFD, various diagnostic tools have to be applied, including conventional mycological culture and nonconventional microbiological tests such as antibody/antigen and molecular tests, as well as histopathology and radiology. In the last few years, various laboratory methods, like the Aspergillus GM immunoassay ( Aspergillus GM EIA), 1,3-ß-D-glucan (BG) assay or polymerase chain reaction (PCR) techniques have been developed for better diagnosis. Since no single indirect test, including radiological methods, provides the definite diagnosis of an invasive fungal infection, the combination of different diagnostic procedures, which include microbiological cultures, histological, serological and molecular methods like PCR together with the pattern of clinical presentation, may currently be the best strategy for the prompt diagnosis, initiation and monitoring of IFDs. Early start of antifungal therapy is mandatory, but clinical diagnostics often do not provide clear evidence of IFD. Integrated care pathways have been proposed for management and therapy of IFDs with either the diagnostic driven strategy using the preemptive antifungal therapy as opposed to the clinical or empirical driven strategy using the 'traditional' empirical antifungal therapy. Antifungal agents preferentially used for systemic therapy of invasive fungal infections are amphotericin B preparations, fluconazole, voriconazole, posaconazole, caspofungin, anidulafungin, micafungin, and most recently isavuconazole. Clinical decision making must consider licensing status, local experience and availability, pharmacological and economic aspects.

The minimizing of fluorescence background in Raman optical activity and Raman spectra of human blood plasma.

PubMed

Tatarkovič, Michal; Synytsya, Alla; Šťovíčková, Lucie; Bunganič, Bohuš; Miškovičová, Michaela; Petruželka, Luboš; Setnička, Vladimír

2015-02-01

Raman optical activity (ROA) is inherently sensitive to the secondary structure of biomolecules, which makes it a method of interest for finding new approaches to clinical applications based on blood plasma analysis, for instance the diagnostics of several protein-misfolding diseases. Unfortunately, real blood plasma exhibits strong background fluorescence when excited at 532 nm; hence, measuring the ROA spectra appears to be impossible. Therefore, we established a suitable method using a combination of kinetic quenchers, filtering, photobleaching, and a mathematical correction of residual fluorescence. Our method reduced the background fluorescence approximately by 90%, which allowed speedup for each measurement by an average of 50%. In addition, the signal-to-noise ratio was significantly increased, while the baseline distortion remained low. We assume that our method is suitable for the investigation of human blood plasma by ROA and may lead to the development of a new tool for clinical diagnostics.

Multimodal fiber-probe spectroscopy as a clinical tool for diagnosing and classifying biological tissues

NASA Astrophysics Data System (ADS)

Cicchi, Riccardo; Anand, Suresh; Fantechi, Riccardo; Giordano, Flavio; Gacci, Mauro; Conti, Valerio; Nesi, Gabriella; Buccoliero, Anna Maria; Carini, Marco; Guerrini, Renzo; Pavone, Francesco Saverio

2017-07-01

An optical fiber probe for multimodal spectroscopy was designed, developed and used for tissue diagnostics. The probe, based on a fiber bundle with optical fibers of various size and properties, allows performing spectroscopic measurements with different techniques, including fluorescence, Raman, and diffuse reflectance, using the same probe. Two visible laser diodes were used for fluorescence spectroscopy, a laser diode emitting in the NIR was used for Raman spectroscopy, and a fiber-coupled halogen lamp for diffuse reflectance. The developed probe was successfully employed for diagnostic purposes on various tissues, including brain and bladder. In particular, the device allowed discriminating healthy tissue from both tumor and dysplastic tissue as well as to perform tumor grading. The diagnostic capabilities of the method, determined using a cross-validation method with a leave-one-out approach, demonstrated high sensitivity and specificity for all the examined samples, as well as a good agreement with histopathological examination performed on the same samples. The obtained results demonstrated that the multimodal approach is crucial for improving diagnostic capabilities with respect to what can be obtained from individual techniques. The experimental setup presented here can improve diagnostic capabilities on a broad range of tissues and has the potential of being used clinically for guiding surgical resection in the near future.

Panel-based Genetic Diagnostic Testing for Inherited Eye Diseases is Highly Accurate and Reproducible and More Sensitive for Variant Detection Than Exome Sequencing

PubMed Central

Bujakowska, Kinga M.; Sousa, Maria E.; Fonseca-Kelly, Zoë D.; Taub, Daniel G.; Janessian, Maria; Wang, Dan Yi; Au, Elizabeth D.; Sims, Katherine B.; Sweetser, David A.; Fulton, Anne B.; Liu, Qin; Wiggs, Janey L.; Gai, Xiaowu; Pierce, Eric A.

2015-01-01

Purpose Next-generation sequencing (NGS) based methods are being adopted broadly for genetic diagnostic testing, but the performance characteristics of these techniques have not been fully defined with regard to test accuracy and reproducibility. Methods We developed a targeted enrichment and NGS approach for genetic diagnostic testing of patients with inherited eye disorders, including inherited retinal degenerations, optic atrophy and glaucoma. In preparation for providing this Genetic Eye Disease (GEDi) test on a CLIA-certified basis, we performed experiments to measure the sensitivity, specificity, reproducibility as well as the clinical sensitivity of the test. Results The GEDi test is highly reproducible and accurate, with sensitivity and specificity for single nucleotide variant detection of 97.9% and 100%, respectively. The sensitivity for variant detection was notably better than the 88.3% achieved by whole exome sequencing (WES) using the same metrics, due to better coverage of targeted genes in the GEDi test compared to commercially available exome capture sets. Prospective testing of 192 patients with IRDs indicated that the clinical sensitivity of the GEDi test is high, with a diagnostic rate of 51%. Conclusion The data suggest that based on quantified performance metrics, selective targeted enrichment is preferable to WES for genetic diagnostic testing. PMID:25412400

Diagnosis of Upper Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of the American Physical Therapy Association

PubMed Central

Levenhagen, Kimberly; Davies, Claire; Perdomo, Marisa; Ryans, Kathryn

2017-01-01

Abstract The Oncology Section of the American Physical Therapy Association (APTA) developed a clinical practice guideline to aid the clinician in diagnosing secondary upper quadrant cancer-related lymphedema. Following a systematic review of published studies and a structured appraisal process, recommendations were written to guide the physical therapist and other health care clinicians in the diagnostic process. Overall clinical practice recommendations were formulated based on the evidence for each diagnostic method and were assigned a grade based on the strength of the evidence for different patient presentations and clinical utility. In an effort to maximize clinical applicability, recommendations were based on the characteristics as to the location and stage of a patient's upper quadrant lymphedema. PMID:28838217

Smartphone-Based Accurate Analysis of Retinal Vasculature towards Point-of-Care Diagnostics

PubMed Central

Xu, Xiayu; Ding, Wenxiang; Wang, Xuemin; Cao, Ruofan; Zhang, Maiye; Lv, Peilin; Xu, Feng

2016-01-01

Retinal vasculature analysis is important for the early diagnostics of various eye and systemic diseases, making it a potentially useful biomarker, especially for resource-limited regions and countries. Here we developed a smartphone-based retinal image analysis system for point-of-care diagnostics that is able to load a fundus image, segment retinal vessels, analyze individual vessel width, and store or uplink results. The proposed system was not only evaluated on widely used public databases and compared with the state-of-the-art methods, but also validated on clinical images directly acquired with a smartphone. An Android app is also developed to facilitate on-site application of the proposed methods. Both visual assessment and quantitative assessment showed that the proposed methods achieved comparable results to the state-of-the-art methods that require high-standard workstations. The proposed system holds great potential for the early diagnostics of various diseases, such as diabetic retinopathy, for resource-limited regions and countries. PMID:27698369

Evaluation of Targeted Next-Generation Sequencing for Detection of Bovine Pathogens in Clinical Samples.

PubMed

Anis, Eman; Hawkins, Ian K; Ilha, Marcia R S; Woldemeskel, Moges W; Saliki, Jeremiah T; Wilkes, Rebecca P

2018-07-01

The laboratory diagnosis of infectious diseases, especially those caused by mixed infections, is challenging. Routinely, it requires submission of multiple samples to separate laboratories. Advances in next-generation sequencing (NGS) have provided the opportunity for development of a comprehensive method to identify infectious agents. This study describes the use of target-specific primers for PCR-mediated amplification with the NGS technology in which pathogen genomic regions of interest are enriched and selectively sequenced from clinical samples. In the study, 198 primers were designed to target 43 common bovine and small-ruminant bacterial, fungal, viral, and parasitic pathogens, and a bioinformatics tool was specifically constructed for the detection of targeted pathogens. The primers were confirmed to detect the intended pathogens by testing reference strains and isolates. The method was then validated using 60 clinical samples (including tissues, feces, and milk) that were also tested with other routine diagnostic techniques. The detection limits of the targeted NGS method were evaluated using 10 representative pathogens that were also tested by quantitative PCR (qPCR), and the NGS method was able to detect the organisms from samples with qPCR threshold cycle ( C T ) values in the 30s. The method was successful for the detection of multiple pathogens in the clinical samples, including some additional pathogens missed by the routine techniques because the specific tests needed for the particular organisms were not performed. The results demonstrate the feasibility of the approach and indicate that it is possible to incorporate NGS as a diagnostic tool in a cost-effective manner into a veterinary diagnostic laboratory. Copyright © 2018 Anis et al.

[Two main mistakes in classificatory and clinical function of DSM-IV, in the case of differential diagnosis between Asperger and autistic disorder].

PubMed

Areta, Joaquín E

2009-01-01

Symptomatic description of what the DSM-IV understands for Asperger's and Autistic Disorder was analyzed. As a result of this revision there was found that a great amount of diagnostic criteria overlap, and lead to the impossibility to make a clear differential diagnosis. The classifying function is, thus, criticized. The clinical function of this diagnostic distinction is analyzed through a clinical case. It is shown it's lack of utility when a therapeutic method should be implemented in a case of Autistic Disorder. It is concluded that the statistical value of the results obtained by using this classificatory instrument should be examined due to this lack of distinction. Also, according to the therapeutic approach witch the author makes reference, it is shown that the diagnostic of any both disorders does not modify the general intervention strategy.

4D co-registration of X-ray and MR-mammograms: initial clinical results and potential incremental diagnostic value.

PubMed

Dietzel, Matthias; Hopp, Torsten; Ruiter, Nicole V; Kaiser, Clemens G; Kaiser, Werner A; Baltzer, Pascal A

2015-01-01

4D co-registration of X-ray- and MR-mammograms (XM and MM) is a new method of image fusion. The present study aims to evaluate its clinical feasibility, radiological accuracy, and potential clinical value. XM and MM of 25 patients were co-registered. Results were evaluated by a blinded reader. Precision of the 4D co-registration was "very good" (mean-score [ms]=7), and lesions were "easier to delineate" (ms=5). In 88.8%, "relevant additional diagnostic information" was present, accounting for a more "confident diagnosis" in 76% (ms=5). 4D co-registration is feasible, accurate, and of potential clinical value. Copyright © 2015 Elsevier Inc. All rights reserved.

Comparative evaluation of matrix-assisted laser desorption ionisation-time of flight mass spectrometry and conventional phenotypic-based methods for identification of clinically important yeasts in a UK-based medical microbiology laboratory.

PubMed

Fatania, Nita; Fraser, Mark; Savage, Mike; Hart, Jason; Abdolrasouli, Alireza

2015-12-01

Performance of matrix-assisted laser desorption ionisation-time of flight mass spectrometry (MALDI-TOF MS) was compared in a side-by side-analysis with conventional phenotypic methods currently in use in our laboratory for identification of yeasts in a routine diagnostic setting. A diverse collection of 200 clinically important yeasts (19 species, five genera) were identified by both methods using standard protocols. Discordant or unreliable identifications were resolved by sequencing of the internal transcribed spacer region of the rRNA gene. MALDI-TOF and conventional methods were in agreement for 182 isolates (91%) with correct identification to species level. Eighteen discordant results (9%) were due to rarely encountered species, hence the difficulty in their identification using traditional phenotypic methods. MALDI-TOF MS enabled rapid, reliable and accurate identification of clinically important yeasts in a routine diagnostic microbiology laboratory. Isolates with rare, unusual or low probability identifications should be confirmed using robust molecular methods. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The Development of a Post-Baccalaureate Certificate Program in Molecular Diagnostics

PubMed Central

Williams, Gail S.; Brown, Judith D.; Keagle, Martha B.

2000-01-01

A post-baccalaureate certificate program in diagnostic molecular sciences was created in 1995 by the Diagnostic Genetic Sciences Program in the School of Allied Health at the University of Connecticut. The required on-campus lecture and laboratory courses include basic laboratory techniques, health care issues, cell biology, immunology, human genetics, research, management, and molecular diagnostic techniques and laboratory in molecular diagnostics. These courses precede a 6-month, full-time practicum at an affiliated full-service molecular laboratory. The practicum includes amplification and blotting methods, a research project, and a choice of specialized electives including DNA sequencing, mutagenesis, in situ hybridization methods, or molecular diagnostic applications in microbiology. Graduates of the program are immediately eligible to sit for the National Credentialing Agency examination in molecular biology to obtain the credential Clinical Laboratory Specialist in Molecular Biology (CLSp(MB). This description of the University of Connecticut program may assist other laboratory science programs in creating similar curricula. PMID:11232107

The agony of choice in dermatophyte diagnostics-performance of different molecular tests and culture in the detection of Trichophyton rubrum and Trichophyton interdigitale.

PubMed

Kupsch, C; Ohst, T; Pankewitz, F; Nenoff, P; Uhrlaß, S; Winter, I; Gräser, Y

2016-08-01

Dermatophytosis caused by dermatophytes of the genera Trichophyton and Microsporum belong to the most frequent mycoses worldwide. Molecular detection methods proved to be highly sensitive and enable rapid and accurate detection of dermatophyte species from clinical specimens. For the first time, we compare the performance of different molecular methods with each other and with conventional diagnostics in the detection of dermatophytoses caused by Trichophyton rubrum and Trichophyton interdigitale in clinical specimens (nail, skin and hair). The compared molecular methods comprise two already published PCR-ELISAs, a published quantitative RT-PCR as well as a newly developed PCR-ELISA targeting the internal transcribed spacer region. We investigated the sensitivity of the assays by analysing 375 clinical samples. In 148 specimens (39.5%) a positive result was gained in at least one of the four molecular tests or by culture, but the number of detected agents differed significantly between some of the assays. The most sensitive assay, a PCR-ELISA targeting a microsatellite region, detected 81 T. rubrum infections followed by an internal transcribed spacer PCR-ELISA (60), quantitative RT-PCR (52) and a topoisomerase II PCR-ELISA (51), whereas cultivation resulted in T. rubrum identification in 37 samples. The pros and cons of all four tests in routine diagnostics are discussed. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Non-invasive diagnostic methods in dentistry

NASA Astrophysics Data System (ADS)

Todea, Carmen

2016-03-01

The paper, will present the most important non-invasive methods for diagnostic, in different fields of dentistry. Moreover, the laser-based methods will be emphasis. In orthodontics, 3D laser scanners are increasingly being used to establish database for normative population and cross-sectional growth changes but also to asses clinical outcomes in orthognatic surgical and non-surgical treatments. In prevention the main methods for diagnostic of demineralization and caries detection in early stages are represented by laser fluorescence - Quantitative Light Florescence (QLF); DiagnoDent-system-655nm; FOTI-Fiberoptic transillumination; DIFOTI-Digital Imaging Fiberoptic transillumination; and Optical Coherence Tomography (OCT). In odontology, Laser Doppler Flowmetry (LDF) is a noninvasive real time method used for determining the tooth vitality by monitoring the pulp microcirculation in traumatized teeth, fractured teeth, and teeth undergoing different conservative treatments. In periodontology, recently study shows the ability of LDF to evaluate the health of gingival tissue in periodontal tissue diseases but also after different periodontal treatments.

Comparative evaluation of fluorescent in situ hybridization and Giemsa microscopy with quantitative real-time PCR technique in detecting malaria parasites in a holoendemic region of Kenya.

PubMed

Osoga, Joseph; Waitumbi, John; Guyah, Bernard; Sande, James; Arima, Cornel; Ayaya, Michael; Moseti, Caroline; Morang'a, Collins; Wahome, Martin; Achilla, Rachel; Awinda, George; Nyakoe, Nancy; Wanja, Elizabeth

2017-07-24

Early and accurate diagnosis of malaria is important in treatment as well as in the clinical evaluation of drugs and vaccines. Evaluation of Giemsa-stained smears remains the gold standard for malaria diagnosis, although diagnostic errors and potential bias estimates of protective efficacy have been reported in practice. Plasmodium genus fluorescent in situ hybridization (P-Genus FISH) is a microscopy-based method that uses fluorescent labelled oligonucleotide probes targeted to pathogen specific ribosomal RNA fragments to detect malaria parasites in whole blood. This study sought to evaluate the diagnostic performance of P-Genus FISH alongside Giemsa microscopy compared to quantitative reverse transcription polymerase chain reaction (qRT-PCR) in a clinical setting. Five hundred study participants were recruited prospectively and screened for Plasmodium parasites by P-Genus FISH assay, and Giemsa microscopy. The microscopic methods were performed by two trained personnel and were blinded, and if the results were discordant a third reading was performed as a tie breaker. The diagnostic performance of both methods was evaluated against qRT-PCR as a more sensitive method. The number of Plasmodium positive cases was 26.8% by P-Genus FISH, 33.2% by Giemsa microscopy, and 51.2% by qRT-PCR. The three methods had 46.8% concordant results with 61 positive cases and 173 negative cases. Compared to qRT-PCR the sensitivity and specificity of P-Genus FISH assay was 29.3 and 75.8%, respectively, while microscopy had 58.2 and 93.0% respectively. Microscopy had a higher positive and negative predictive values (89.8 and 68.0% respectively) compared to P-Genus FISH (56.0 and 50.5%). In overall, microscopy had a good measure of agreement (76%, k = 0.51) compared to P-Genus FISH (52%, k = 0.05). The diagnostic performance of P-Genus FISH was shown to be inferior to Giemsa microscopy in the clinical samples. This hinders the possible application of the method in the field despite the many advantages of the method especially diagnosis of low parasite density infections. The P-Genus assay has great potential but application of the method in clinical setting would rely on extensive training of microscopist and continuous proficiency testing.

Medical image computing for computer-supported diagnostics and therapy. Advances and perspectives.

PubMed

Handels, H; Ehrhardt, J

2009-01-01

Medical image computing has become one of the most challenging fields in medical informatics. In image-based diagnostics of the future software assistance will become more and more important, and image analysis systems integrating advanced image computing methods are needed to extract quantitative image parameters to characterize the state and changes of image structures of interest (e.g. tumors, organs, vessels, bones etc.) in a reproducible and objective way. Furthermore, in the field of software-assisted and navigated surgery medical image computing methods play a key role and have opened up new perspectives for patient treatment. However, further developments are needed to increase the grade of automation, accuracy, reproducibility and robustness. Moreover, the systems developed have to be integrated into the clinical workflow. For the development of advanced image computing systems methods of different scientific fields have to be adapted and used in combination. The principal methodologies in medical image computing are the following: image segmentation, image registration, image analysis for quantification and computer assisted image interpretation, modeling and simulation as well as visualization and virtual reality. Especially, model-based image computing techniques open up new perspectives for prediction of organ changes and risk analysis of patients and will gain importance in diagnostic and therapy of the future. From a methodical point of view the authors identify the following future trends and perspectives in medical image computing: development of optimized application-specific systems and integration into the clinical workflow, enhanced computational models for image analysis and virtual reality training systems, integration of different image computing methods, further integration of multimodal image data and biosignals and advanced methods for 4D medical image computing. The development of image analysis systems for diagnostic support or operation planning is a complex interdisciplinary process. Image computing methods enable new insights into the patient's image data and have the future potential to improve medical diagnostics and patient treatment.

Study protocol of the internet user Cohort for Unbiased Recognition of gaming disorder in Early adolescence (iCURE), Korea, 2015–2019

PubMed Central

Jeong, Hyunsuk; Jo, Sun-Jin; Lee, Seung-Yup; Kim, Eunjin; Son, Hye Jung; Han, Hyun-ho; Lee, Hae Kook; Kweon, Yong-Sil; Bhang, Soo-young; Choi, Jung-Seok; Kim, Bung-Nyun; Gentile, Douglas A; Potenza, Marc N

2017-01-01

Introduction In 2013, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) proposed nine internet gaming disorder (IGD) diagnostic criteria as a condition warranting further empirical and clinical research. The aim of this study is to clarify the natural and clinical courses of IGD proposed DSM-5 in adolescents and to evaluate its risk and protective factors. Methods and analysis The Internet user Cohort for Unbiased Recognition of gaming disorder in Early Adolescence (iCURE) study is an ongoing multidisciplinary, prospective, longitudinal cohort study conducted in 21 schools in Korea. Participant recruitment commenced in March 2015 with the goal of registering 3000 adolescents. The baseline assessment included surveys on emotional, social and environmental characteristics. A parent or guardian completed questionnaires and a structured psychiatric comorbidity diagnostic interview regarding their children. Adolescents with the Internet Game Use-Elicited Symptom Screen total scores of 6 or higher were asked to participate in the clinical diagnostic interview. Two subcohorts of adolescents were constructed: a representative subcohort and a clinical evaluation subcohort. The representative subcohort comprises a randomly selected 10% of the iCURE to investigate the clinical course of IGD based on clinical diagnosis and to estimate the false negative rate. The clinical evaluation subcohort comprised participants meeting three or more of the nine IGD criteria, determined by clinical diagnostic interview, to show the clinical course of IGD. Follow-up data will be collected annually for the 3 years following the baseline assessments. The primary endpoint is 2-year incidence, remission and recurrence rates of IGD. Cross-sectional and longitudinal associations between exposures and outcomes as well as mediation factors will be evaluated. Ethics and dissemination This study is approved by the Institutional Review Board of the Catholic University of Korea. Results will be published in peer-reviewed journals. Trial registration number ClinicalTrials.gov (identifier: NCT02415322). PMID:28982839

New diagnostic methods for pneumonia in the ICU.

PubMed

Douglas, Ivor S

2016-04-01

Pneumonia leading to severe sepsis and critical illness including respiratory failure remains a common and therapeutically challenging diagnosis. Current clinical approaches to surveillance, early detection, and conventional culture-based microbiology are inadequate for optimal targeted antibiotic treatment and stewardship. Efforts to enhance diagnosis of community-acquired and health care-acquired pneumonia, including ventilator-associated pneumonia (VAP), are the focus of recent studies reviewed here. Newer surveillance definitions are sensitive for pneumonia in the ICU including VAP but consistently underdetect patients that are clinically shown to have bacterial VAP based on clinical diagnostic criteria and response to antibiotic treatment. Routinely measured plasma biomarkers, including procalcitonin and C-reactive protein, lack sufficient precision and predictive accuracy to inform diagnosis. Novel rapid microbiological diagnostics, including nucleic-acid amplification, mass spectrometry, and fluorescence microscopy-based technologies are promising approaches for the future. Exhaled breath biomarkers, including measurement of volatile organic compounds, represent a future approach. The integration of novel diagnostics for rapid microbial identification, resistance phenotyping, and antibiotic sensitivity testing into usual care practice could significantly transform the care of patients and potentially inform significantly improved targeted antimicrobial selection, de-escalation, and stewardship.

[Prostate biopsy under magnetic resonance imaging guidance].

PubMed

Kuplevatskiy, V I; CherkashiN, M A; Roshchin, D A; Berezina, N A; Vorob'ev, N A

2016-01-01

Prostate cancer (PC) is one of the most important problems in modern oncology. According to statistical data, PC ranks second in the cancer morbidity structure in the Russian Federation and developed countries and its prevalence has been progressively increasing over the past decade. A need for early diagnosis and maximally accurate morphological verification of the diagnosis in difficult clinical cases (inconvenient tumor location for standard transrectal biopsy; gland scarring changes concurrent with prostatitis and hemorrhage; threshold values of prostate-specific antigen with unclear changes in its doubling per unit time; suspicion of biochemical recurrence or clinical tumor progression after special treatment) leads to revised diagnostic algorithms and clinically introduced new high-tech invasive diagnostic methods. This paper gives the first analysis of literature data on Russian practice using one of the new methods to verify prostate cancer (transrectal prostate cancer under magnetic resonance imaging (MRI) guidance). The have sought the 1995-2015 data in the MEDLINE and Pubmed.

Ultrasound-Guided Percutaneous Thyroid Nodule Core Biopsy: Clinical Utility in Patients with Prior Nondiagnostic Fine-Needle Aspirate

PubMed Central

Vij, Abhinav; Seale, Melanie K.; Desai, Gaurav; Halpern, Elkan; Faquin, William C.; Parangi, Sareh; Hahn, Peter F.; Daniels, Gilbert H.

2012-01-01

Background Five percent to 20% of thyroid nodule fine-needle aspiration (FNA) samples are nondiagnostic. The objective of this study was to determine whether a combination of FNA and core biopsy (CFNACB) would yield a higher proportion of diagnostic readings compared with FNA alone in patients with a history of one or more prior nondiagnostic FNA readings. Methods We conducted a retrospective study of 90 core biopsies (CBs) performed in 82 subjects (55 women and 27 men) between 2006 and 2008 in an outpatient clinic. Results CFNACB yielded a diagnostic reading in 87%. The diagnostic reading yield of the CB component of CFNACB was significantly superior to the concurrent FNA component, with CB yielding a diagnosis in 77% of cases and FNA yielding a diagnosis in 47% (p<0.0001). The combination of CB and FNA had a higher diagnostic reading yield than either alone. In 69 nodules that had only one prior nondiagnostic FNA, CB was diagnostic in 74%, FNA was diagnostic in 52%, CFNACB was diagnostic in 87%, and CB performed significantly better than FNA (p=0.0135). In 21 nodules with two or more prior nondiagnostic FNAs, CFNACB and CB were diagnostic in 86%, FNA was diagnostic in 29%, and CB was significantly better than FNA (p=0.0005). Clinical, ultrasound, or histopathologic follow-up was available for 81% (73/90) of the CFNACB procedures. No subject with a benign CFNACB reading was diagnosed with thyroid malignancy in the follow-up period (range 4–37 months, mean 18 months), although one subject had minimal increase in nodule size and was awaiting repeat sonography at study conclusion. Conclusion Thyroid nodule CFNACB is safe and clinically useful in selected patients when a prior FNA reading is nondiagnostic. CFNACB is superior to either CB or FNA alone. CFNACB should be strongly considered as an alternative to surgery in individuals with two prior nondiagnostic FNAs. PMID:22304390

[The development of the methods for the determination of nickel and its urine levels by inversion voltamperometry].

PubMed

Antoshina, L I; Pavlovskaia, N A

1999-01-01

The authors created a method detecting nickel through inversion voltamperometry by Russian analyzer CVA = 1BM. The method is diagnostic in hygienic, clinical and toxicologic studies for measuring quantity of nickel that enters human body during occupational activities.

Tuberculous Lymphadenitis and Parotitis.

PubMed

Cataño, Juan Carlos; Robledo, Jaime

2016-12-01

Tuberculous lymphadenitis is the most common extrapulmonary manifestation of disseminated tuberculosis (TB). It is considered to be the local manifestation of the systemic disease that has disseminated to local lymph nodes, but a high index of suspicion is needed for the diagnosis, because there are several infectious and noninfectious diseases that can mimic the same clinical picture. In recent years, different diagnostic methods have been introduced, including fine-needle aspiration cytology, which has emerged as a simple outpatient diagnostic procedure that replaced the complete excisional node biopsy, and a number of molecular methods which have greatly improved diagnostic accuracy. This chapter covers the most actual knowledge in terms of epidemiology, clinical manifestations, pathogenesis, and treatment and emphasizes current trends in diagnosis of tuberculous lymphadenitis. TB parotid gland involvement is extremely rare, even in countries in which TB is endemic. Because of the clinical similarity, parotid malignancy and other forms of parotid inflammatory disease always take priority over the rarely encountered TB parotitis when it comes to differential diagnosis. As a result, clinicians often fail to make a timely diagnosis of TB parotitis when facing a patient with a slowly growing parotid lump. This chapter highlights the most important features of this uncommon disease.

Software for enhanced video capsule endoscopy: challenges for essential progress.

PubMed

Iakovidis, Dimitris K; Koulaouzidis, Anastasios

2015-03-01

Video capsule endoscopy (VCE) has revolutionized the diagnostic work-up in the field of small bowel diseases. Furthermore, VCE has the potential to become the leading screening technique for the entire gastrointestinal tract. Computational methods that can be implemented in software can enhance the diagnostic yield of VCE both in terms of efficiency and diagnostic accuracy. Since the appearance of the first capsule endoscope in clinical practice in 2001, information technology (IT) research groups have proposed a variety of such methods, including algorithms for detecting haemorrhage and lesions, reducing the reviewing time, localizing the capsule or lesion, assessing intestinal motility, enhancing the video quality and managing the data. Even though research is prolific (as measured by publication activity), the progress made during the past 5 years can only be considered as marginal with respect to clinically significant outcomes. One thing is clear-parallel pathways of medical and IT scientists exist, each publishing in their own area, but where do these research pathways meet? Could the proposed IT plans have any clinical effect and do clinicians really understand the limitations of VCE software? In this Review, we present an in-depth critical analysis that aims to inspire and align the agendas of the two scientific groups.

[Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs].

PubMed

He, Wei; Xie, Yanming; Wang, Yongyan

2011-12-01

Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.

Clinical data miner: an electronic case report form system with integrated data preprocessing and machine-learning libraries supporting clinical diagnostic model research.

PubMed

Installé, Arnaud Jf; Van den Bosch, Thierry; De Moor, Bart; Timmerman, Dirk

2014-10-20

Using machine-learning techniques, clinical diagnostic model research extracts diagnostic models from patient data. Traditionally, patient data are often collected using electronic Case Report Form (eCRF) systems, while mathematical software is used for analyzing these data using machine-learning techniques. Due to the lack of integration between eCRF systems and mathematical software, extracting diagnostic models is a complex, error-prone process. Moreover, due to the complexity of this process, it is usually only performed once, after a predetermined number of data points have been collected, without insight into the predictive performance of the resulting models. The objective of the study of Clinical Data Miner (CDM) software framework is to offer an eCRF system with integrated data preprocessing and machine-learning libraries, improving efficiency of the clinical diagnostic model research workflow, and to enable optimization of patient inclusion numbers through study performance monitoring. The CDM software framework was developed using a test-driven development (TDD) approach, to ensure high software quality. Architecturally, CDM's design is split over a number of modules, to ensure future extendability. The TDD approach has enabled us to deliver high software quality. CDM's eCRF Web interface is in active use by the studies of the International Endometrial Tumor Analysis consortium, with over 4000 enrolled patients, and more studies planned. Additionally, a derived user interface has been used in six separate interrater agreement studies. CDM's integrated data preprocessing and machine-learning libraries simplify some otherwise manual and error-prone steps in the clinical diagnostic model research workflow. Furthermore, CDM's libraries provide study coordinators with a method to monitor a study's predictive performance as patient inclusions increase. To our knowledge, CDM is the only eCRF system integrating data preprocessing and machine-learning libraries. This integration improves the efficiency of the clinical diagnostic model research workflow. Moreover, by simplifying the generation of learning curves, CDM enables study coordinators to assess more accurately when data collection can be terminated, resulting in better models or lower patient recruitment costs.

Outcome of Whole Exome Sequencing for Diagnostic Odyssey Cases of an Individualized Medicine Clinic: The Mayo Clinic Experience.

PubMed

Lazaridis, Konstantinos N; Schahl, Kimberly A; Cousin, Margot A; Babovic-Vuksanovic, Dusica; Riegert-Johnson, Douglas L; Gavrilova, Ralitza H; McAllister, Tammy M; Lindor, Noralane M; Abraham, Roshini S; Ackerman, Michael J; Pichurin, Pavel N; Deyle, David R; Gavrilov, Dimitar K; Hand, Jennifer L; Klee, Eric W; Stephens, Michael C; Wick, Myra J; Atkinson, Elizabeth J; Linden, David R; Ferber, Matthew J; Wieben, Eric D; Farrugia, Gianrico

2016-03-01

To describe the experience and outcome of performing whole-exome sequencing (WES) for resolution of patients on a diagnostic odyssey in the first 18 months of an individualized medicine clinic (IMC). The IMC offered WES to physicians of Mayo Clinic practice for patients with suspected genetic disease. DNA specimens of the proband and relatives were submitted to WES laboratories. We developed the Genomic Odyssey Board with multidisciplinary expertise to determine the appropriateness for IMC services, review WES reports, and make the final decision about whether the exome findings explain the disease. This study took place from September 30, 2012, to March 30, 2014. In the first 18 consecutive months, the IMC received 82 consultation requests for patients on a diagnostic odyssey. The Genomic Odyssey Board deferred 7 cases and approved 75 cases to proceed with WES. Seventy-one patients met with an IMC genomic counselor. Fifty-one patients submitted specimens for WES testing, and the results have been received for all. There were 15 cases in which a diagnosis was made on the basis of WES findings; thus, the positive diagnostic yield of this practice was 29%. The mean cost per patient for this service was approximately $8000. Medicaid supported 27% of the patients, and 38% of patients received complete or partial insurance coverage. The significant diagnostic yield, moderate cost, and notable health marketplace acceptance for WES compared with conventional genetic testing make the former method a rational diagnostic approach for patients on a diagnostic odyssey. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

Diagnostic grand rounds: a new teaching concept to train diagnostic reasoning.

PubMed

Stieger, Stefan; Praschinger, Andrea; Kletter, Kurt; Kainberger, Franz

2011-06-01

Diagnostic reasoning is a core skill in teaching and learning in undergraduate curricula. Diagnostic grand rounds (DGRs) as a subform of grand rounds are intended to train the students' skills in the selection of appropriate tests and in the interpretation of test results. The aim of this study was to test DGRs for their ability to improve diagnostic reasoning by using a pre-post-test design. During one winter term, all 398 fifth-year students (36.1% male, 63.9% female) solved 23 clinical cases presented in 8 DGRs. In an online questionnaire, a Diagnostic Thinking Inventory (DTI) with 41 items was evaluated for flexibility in thinking and structure of knowledge in memory. Results were correlated with those from a summative multiple-choice knowledge test and of the learning objectives in a logbook. The students' DTI scores in the post-test were significantly higher than those reported in the pre-test. DTI scores at either testing time did not correlate with medical knowledge as assessed by a multiple-choice knowledge test. Abilities acquired during clinical clerkships as documented in a logbook could only account for a small proportion of the increase in the flexibility subscale score. This effect still remained significant after accounting for potential confounders. Establishing DGRs proofed to be an effective way of successfully improving both students' diagnostic reasoning and the ability to select the appropriate test method in routine clinical practice. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

Bayesian evaluation of clinical diagnostic test characteristics of visual observations and remote monitoring to diagnose bovine respiratory disease in beef calves.

PubMed

White, Brad J; Goehl, Dan R; Amrine, David E; Booker, Calvin; Wildman, Brian; Perrett, Tye

2016-04-01

Accurate diagnosis of bovine respiratory disease (BRD) in beef cattle is a critical facet of therapeutic programs through promotion of prompt treatment of diseased calves in concert with judicious use of antimicrobials. Despite the known inaccuracies, visual observation (VO) of clinical signs is the conventional diagnostic modality for BRD diagnosis. Objective methods of remotely monitoring cattle wellness could improve diagnostic accuracy; however, little information exists describing the accuracy of this method compared to traditional techniques. The objective of this research is to employ Bayesian methodology to elicit diagnostic characteristics of conventional VO compared to remote early disease identification (REDI) to diagnose BRD. Data from previous literature on the accuracy of VO were combined with trial data consisting of direct comparison between VO and REDI for BRD in two populations. No true gold standard diagnostic test exists for BRD; therefore, estimates of diagnostic characteristics of each test were generated using Bayesian latent class analysis. Results indicate a 90.0% probability that the sensitivity of REDI (median 81.3%; 95% probability interval [PI]: 55.5, 95.8) was higher than VO sensitivity (64.5%; PI: 57.9, 70.8). The specificity of REDI (median 92.9%; PI: 88.2, 96.9) was also higher compared to VO (median 69.1%; PI: 66.3, 71.8). The differences in sensitivity and specificity resulted in REDI exhibiting higher positive and negative predictive values in both high (41.3%) and low (2.6%) prevalence situations. This research illustrates the potential of remote cattle monitoring to augment conventional methods of BRD diagnosis resulting in more accurate identification of diseased cattle. Copyright © 2016 Elsevier B.V. All rights reserved.

Clinical review: Current state and future perspectives in the diagnosis of diabetes insipidus: a clinical review.

PubMed

Fenske, Wiebke; Allolio, Bruno

2012-10-01

The differential diagnosis of diabetes insipidus (DI) is often challenging but essential, because treatment may vary substantially. This article analyzes the database and performance of currently used differential diagnostic tests for DI and discusses future perspectives for diagnostic improvement. A review of electronic and print data comprising original and review articles retrieved from the PubMed or Cochrane Library database up to January 2012 was conducted. The search term "polyuria polydipsia syndrome" was cross-referenced with underlying forms of disease and associated clinical, diagnostic, and therapeutic MeSH terms. In addition, references from review articles and textbook chapters were screened for papers containing original data. Search results were narrowed to articles containing primary data with a description of criteria for the differential diagnosis of DI. Fifteen articles on differential diagnosis of DI were identified, mainly consisting of small series of patients, and mostly covering only part of the differential diagnostic spectrum of DI. Test protocols differed, and prospective validation of diagnostic criteria was consistently missing. Inconsistent data were reported on the diagnostic superiority of direct plasma arginine vasopressin determination over the indirect water deprivation test. Both test methods revealed limitations, especially in the differentiation of disorders with a milder phenotype. The available data demonstrate limitations of current biochemical tests for the differential diagnosis of DI, potentially leading to incorrect diagnosis and treatment. The newly available assay for copeptin, the C terminus of the vasopressin precursor, holds promise for a higher diagnostic specificity and simplification of the differential diagnostic protocol in DI.

Quantitative comparison of DNA methylation assays for biomarker development and clinical applications.

PubMed

2016-07-01

DNA methylation patterns are altered in numerous diseases and often correlate with clinically relevant information such as disease subtypes, prognosis and drug response. With suitable assays and after validation in large cohorts, such associations can be exploited for clinical diagnostics and personalized treatment decisions. Here we describe the results of a community-wide benchmarking study comparing the performance of all widely used methods for DNA methylation analysis that are compatible with routine clinical use. We shipped 32 reference samples to 18 laboratories in seven different countries. Researchers in those laboratories collectively contributed 21 locus-specific assays for an average of 27 predefined genomic regions, as well as six global assays. We evaluated assay sensitivity on low-input samples and assessed the assays' ability to discriminate between cell types. Good agreement was observed across all tested methods, with amplicon bisulfite sequencing and bisulfite pyrosequencing showing the best all-round performance. Our technology comparison can inform the selection, optimization and use of DNA methylation assays in large-scale validation studies, biomarker development and clinical diagnostics.

[Hernia surgery in urology: part 1: inguinal, femoral and umbilical hernias - fundamentals of clinical diagnostics and treatment].

PubMed

Franz, T; Schwalenberg, T; Dietrich, A; Müller, J; Stolzenburg, J-U

2013-05-01

Hernias are a common occurrence with correspondingly huge clinical and economic impacts on the healthcare system. The most common forms of hernia which need to be diagnosed and treated in routine urological work are inguinal and umbilical hernias. With the objective of reconstructing and stabilizing the inguinal canal there are the possibilities of open and minimally invasive surgery and both methods can be performed with suture or mesh repair. Indications for surgery of umbilical hernias are infrequent although this is possible with little effort under local anesthesia. This article presents an overview of the epidemiology, pathogenesis, clinical symptoms, diagnostics and therapy of inguinal, femoral and umbilical hernias.

Textbook of respiratory medicine

DOE Office of Scientific and Technical Information (OSTI.GOV)

Murray, J.F.; Nadel, J.

1987-01-01

This book presents a clinical reference of respiratory medicine. It also details basic science aspects of pulmonary physiology and describes recently developed, sophisticated diagnostic tools and therapeutic methods. It also covers anatomy, physiology, pharmacology, and pathology; microbiologic, radiologic, nuclear medicine, and biopsy methods for diagnosis.

Remote Skin Tissue Diagnostics In Vivo By Fiber Optic Evanescent Wave Fourier Transform Infrared (FEW-FTIR) Spectroscopy

NASA Astrophysics Data System (ADS)

Kolyakov, Sergei; Afanasyeva, Natalia; Bruch, Reinhard; Afanasyeva, Natalia

1998-05-01

The new method of fiber optical evanescent wave Fourier transform infrared (FEW-FTIR) spectroscopy has been applied to the diagnostics of normal skin tissue, as well as precancerous and cancerous conditions. The FEW-FTIR technique is nondestructive and sensitive to changes of vibrational spectra in the IR region, without heating and damaging human and animal skin tissue. Therefore this method and technique is an ideal diagnostic tool for tumor and cancer characterization at an early stage of development on a molecular level. The application of fiber optic technology in the middle infrared (MIR) region is relatively inexpensive and can be adapted easily to any commercially available tabletop FTIR spectrometers. This method of diagnostics is fast (several seconds), and can be applied to many fields. Noninvasive medical diagnostics of skin cancer and other skin diseases in vivo, ex vivo, and in vitro allow for the development of convenient, remote clinical applications in dermatology and related fields. The spectral variations from normal to pathological skin tissue and environmental influence on skin have been measured.

Diagnostic image quality in gynaecological ultrasound: Who should measure it, what should we measure and how?

PubMed Central

Knapp, Karen

2013-01-01

Assessment of diagnostic image quality in gynaecological ultrasound is an important aspect of imaging department quality assurance. This may be addressed through audit, but who should undertake the audit, what should be measured and how, remains contentious. The aim of this study was to identify whether peer audit is a suitable method of assessing the diagnostic quality of gynaecological ultrasound images. Nineteen gynaecological ultrasound studies were independently assessed by six sonographers utilising a pilot version of an audit tool. Outcome measures were levels of inter-rater agreement using different data collection methods (binary scores, Likert scale, continuous scale), effect of ultrasound study difficulty on study score and whether systematic differences were present between reviewers of different clinical grades and length of experience. Inter-rater agreement ranged from moderate to good depending on the data collection method. A continuous scale gave the highest level of inter-rater agreement with an intra-class correlation coefficient of 0.73. A strong correlation (r = 0.89) between study difficulty and study score was yielded. Length of clinical experience between reviewers had no effect on the audit scores, but individuals of a higher clinical grade gave significantly lower scores than those of a lower grade (p = 0.04). Peer audit is a promising tool in the assessment of ultrasound image quality. Continuous scales seem to be the best method of data collection implying a strong element of heuristically driven decision making by reviewing ultrasound practitioners. PMID:27433192

Image processing and machine learning for fully automated probabilistic evaluation of medical images.

PubMed

Sajn, Luka; Kukar, Matjaž

2011-12-01

The paper presents results of our long-term study on using image processing and data mining methods in a medical imaging. Since evaluation of modern medical images is becoming increasingly complex, advanced analytical and decision support tools are involved in integration of partial diagnostic results. Such partial results, frequently obtained from tests with substantial imperfections, are integrated into ultimate diagnostic conclusion about the probability of disease for a given patient. We study various topics such as improving the predictive power of clinical tests by utilizing pre-test and post-test probabilities, texture representation, multi-resolution feature extraction, feature construction and data mining algorithms that significantly outperform medical practice. Our long-term study reveals three significant milestones. The first improvement was achieved by significantly increasing post-test diagnostic probabilities with respect to expert physicians. The second, even more significant improvement utilizes multi-resolution image parametrization. Machine learning methods in conjunction with the feature subset selection on these parameters significantly improve diagnostic performance. However, further feature construction with the principle component analysis on these features elevates results to an even higher accuracy level that represents the third milestone. With the proposed approach clinical results are significantly improved throughout the study. The most significant result of our study is improvement in the diagnostic power of the whole diagnostic process. Our compound approach aids, but does not replace, the physician's judgment and may assist in decisions on cost effectiveness of tests. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Developments in label-free microfluidic methods for single-cell analysis and sorting.

PubMed

Carey, Thomas R; Cotner, Kristen L; Li, Brian; Sohn, Lydia L

2018-04-24

Advancements in microfluidic technologies have led to the development of many new tools for both the characterization and sorting of single cells without the need for exogenous labels. Label-free microfluidics reduce the preparation time, reagents needed, and cost of conventional methods based on fluorescent or magnetic labels. Furthermore, these devices enable analysis of cell properties such as mechanical phenotype and dielectric parameters that cannot be characterized with traditional labels. Some of the most promising technologies for current and future development toward label-free, single-cell analysis and sorting include electronic sensors such as Coulter counters and electrical impedance cytometry; deformation analysis using optical traps and deformation cytometry; hydrodynamic sorting such as deterministic lateral displacement, inertial focusing, and microvortex trapping; and acoustic sorting using traveling or standing surface acoustic waves. These label-free microfluidic methods have been used to screen, sort, and analyze cells for a wide range of biomedical and clinical applications, including cell cycle monitoring, rapid complete blood counts, cancer diagnosis, metastatic progression monitoring, HIV and parasite detection, circulating tumor cell isolation, and point-of-care diagnostics. Because of the versatility of label-free methods for characterization and sorting, the low-cost nature of microfluidics, and the rapid prototyping capabilities of modern microfabrication, we expect this class of technology to continue to be an area of high research interest going forward. New developments in this field will contribute to the ongoing paradigm shift in cell analysis and sorting technologies toward label-free microfluidic devices, enabling new capabilities in biomedical research tools as well as clinical diagnostics. This article is categorized under: Diagnostic Tools > Biosensing Diagnostic Tools > Diagnostic Nanodevices. © 2018 Wiley Periodicals, Inc.

Proposed Diagnostic Criteria for Smartphone Addiction

PubMed Central

Lin, Yu-Hsuan; Chiang, Chih-Lin; Lin, Po-Hsien; Chang, Li-Ren; Ko, Chih-Hung; Lee, Yang-Han

2016-01-01

Background Global smartphone penetration has led to unprecedented addictive behaviors. The aims of this study are to develop diagnostic criteria of smartphone addiction and to examine the discriminative ability and the validity of the diagnostic criteria. Methods We developed twelve candidate criteria for characteristic symptoms of smartphone addiction and four criteria for functional impairment caused by excessive smartphone use. The participants consisted of 281 college students. Each participant was systematically assessed for smartphone-using behaviors by psychiatrist’s structured diagnostic interview. The sensitivity, specificity, and diagnostic accuracy of the candidate symptom criteria were analyzed with reference to the psychiatrists’ clinical global impression. The optimal model selection with its cutoff point of the diagnostic criteria differentiating the smartphone addicted subjects from non-addicted subjects was then determined by the best diagnostic accuracy. Results Six symptom criteria model with optimal cutoff point were determined based on the maximal diagnostic accuracy. The proposed smartphone addiction diagnostic criteria consisted of (1) six symptom criteria, (2) four functional impairment criteria and (3) exclusion criteria. Setting three symptom criteria as the cutoff point resulted in the highest diagnostic accuracy (84.3%), while the sensitivity and specificity were 79.4% and 87.5%, respectively. We suggested determining the functional impairment by two or more of the four domains considering the high accessibility and penetration of smartphone use. Conclusion The diagnostic criteria of smartphone addiction demonstrated the core symptoms “impaired control” paralleled with substance related and addictive disorders. The functional impairment involved multiple domains provide a strict standard for clinical assessment. PMID:27846211

Standardized Methods to Generate Mock (Spiked) Clinical Specimens by Spiking Blood or Plasma with Cultured Pathogens

PubMed Central

Dong, Ming; Fisher, Carolyn; Añez, Germán; Rios, Maria; Nakhasi, Hira L.; Hobson, J. Peyton; Beanan, Maureen; Hockman, Donna; Grigorenko, Elena; Duncan, Robert

2016-01-01

Aims To demonstrate standardized methods for spiking pathogens into human matrices for evaluation and comparison among diagnostic platforms. Methods and Results This study presents detailed methods for spiking bacteria or protozoan parasites into whole blood and virus into plasma. Proper methods must start with a documented, reproducible pathogen source followed by steps that include standardized culture, preparation of cryopreserved aliquots, quantification of the aliquots by molecular methods, production of sufficient numbers of individual specimens and testing of the platform with multiple mock specimens. Results are presented following the described procedures that showed acceptable reproducibility comparing in-house real-time PCR assays to a commercially available multiplex molecular assay. Conclusions A step by step procedure has been described that can be followed by assay developers who are targeting low prevalence pathogens. Significance and Impact of Study The development of diagnostic platforms for detection of low prevalence pathogens such as biothreat or emerging agents is challenged by the lack of clinical specimens for performance evaluation. This deficit can be overcome using mock clinical specimens made by spiking cultured pathogens into human matrices. To facilitate evaluation and comparison among platforms, standardized methods must be followed in the preparation and application of spiked specimens. PMID:26835651

MO-F-204-00: Preparing for the ABR Diagnostic and Nuclear Medical Physics Exams

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance of allmore » aspects of clinical medical physics. All parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those unique aspects of the nuclear exam, and how preparing for a second specialty differs from the first. Medical physicists who recently completed each ABR exam portion will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations How to prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations How to prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.« less

MO-F-204-02: Preparing for Part 2 of the ABR Diagnostic Physics Exam

DOE Office of Scientific and Technical Information (OSTI.GOV)

Szczykutowicz, T.

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance of allmore » aspects of clinical medical physics. All parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those unique aspects of the nuclear exam, and how preparing for a second specialty differs from the first. Medical physicists who recently completed each ABR exam portion will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations How to prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations How to prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.« less

MO-F-204-03: Preparing for Part 3 of the ABR Diagnostic Physics Exam

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zambelli, J.

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance of allmore » aspects of clinical medical physics. All parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those unique aspects of the nuclear exam, and how preparing for a second specialty differs from the first. Medical physicists who recently completed each ABR exam portion will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations How to prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations How to prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.« less

MO-F-204-01: Preparing for Part 1 of the ABR Diagnostic Physics Exam

DOE Office of Scientific and Technical Information (OSTI.GOV)

McKenney, S.

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance of allmore » aspects of clinical medical physics. All parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those unique aspects of the nuclear exam, and how preparing for a second specialty differs from the first. Medical physicists who recently completed each ABR exam portion will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations How to prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations How to prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.« less

WE-D-213-00: Preparing for the ABR Diagnostic and Nuclear Medicine Physics Exams

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR professional certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance ofmore » all aspects of clinical medical physics. All three parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation and skill sets necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those aspects that are unique to the nuclear exam. Medical physicists who have recently completed each of part of the ABR exam will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations How to Prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations How to Prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.« less

WE-D-213-01: Preparing for Part 1 of the ABR Diagnostic Physics Exam

DOE Office of Scientific and Technical Information (OSTI.GOV)

Simiele, S.

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR professional certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance ofmore » all aspects of clinical medical physics. All three parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation and skill sets necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those aspects that are unique to the nuclear exam. Medical physicists who have recently completed each of part of the ABR exam will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations How to Prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations How to Prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.« less

WE-D-213-03: Preparing for Part 3 of the ABR Diagnostic Physics Exam

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bevins, N.

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR professional certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance ofmore » all aspects of clinical medical physics. All three parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation and skill sets necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those aspects that are unique to the nuclear exam. Medical physicists who have recently completed each of part of the ABR exam will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations How to Prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations How to Prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.« less

WE-D-213-02: Preparing for Part 2 of the ABR Diagnostic Physics Exam

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zambelli, J.

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR professional certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance ofmore » all aspects of clinical medical physics. All three parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation and skill sets necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those aspects that are unique to the nuclear exam. Medical physicists who have recently completed each of part of the ABR exam will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations How to Prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations How to Prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.« less

Improving statistical inference on pathogen densities estimated by quantitative molecular methods: malaria gametocytaemia as a case study.

PubMed

Walker, Martin; Basáñez, María-Gloria; Ouédraogo, André Lin; Hermsen, Cornelus; Bousema, Teun; Churcher, Thomas S

2015-01-16

Quantitative molecular methods (QMMs) such as quantitative real-time polymerase chain reaction (q-PCR), reverse-transcriptase PCR (qRT-PCR) and quantitative nucleic acid sequence-based amplification (QT-NASBA) are increasingly used to estimate pathogen density in a variety of clinical and epidemiological contexts. These methods are often classified as semi-quantitative, yet estimates of reliability or sensitivity are seldom reported. Here, a statistical framework is developed for assessing the reliability (uncertainty) of pathogen densities estimated using QMMs and the associated diagnostic sensitivity. The method is illustrated with quantification of Plasmodium falciparum gametocytaemia by QT-NASBA. The reliability of pathogen (e.g. gametocyte) densities, and the accompanying diagnostic sensitivity, estimated by two contrasting statistical calibration techniques, are compared; a traditional method and a mixed model Bayesian approach. The latter accounts for statistical dependence of QMM assays run under identical laboratory protocols and permits structural modelling of experimental measurements, allowing precision to vary with pathogen density. Traditional calibration cannot account for inter-assay variability arising from imperfect QMMs and generates estimates of pathogen density that have poor reliability, are variable among assays and inaccurately reflect diagnostic sensitivity. The Bayesian mixed model approach assimilates information from replica QMM assays, improving reliability and inter-assay homogeneity, providing an accurate appraisal of quantitative and diagnostic performance. Bayesian mixed model statistical calibration supersedes traditional techniques in the context of QMM-derived estimates of pathogen density, offering the potential to improve substantially the depth and quality of clinical and epidemiological inference for a wide variety of pathogens.

Clinical whole-exome sequencing for the diagnosis of rare disorders with congenital anomalies and/or intellectual disability: substantial interest of prospective annual reanalysis.

PubMed

Nambot, Sophie; Thevenon, Julien; Kuentz, Paul; Duffourd, Yannis; Tisserant, Emilie; Bruel, Ange-Line; Mosca-Boidron, Anne-Laure; Masurel-Paulet, Alice; Lehalle, Daphné; Jean-Marçais, Nolwenn; Lefebvre, Mathilde; Vabres, Pierre; El Chehadeh-Djebbar, Salima; Philippe, Christophe; Tran Mau-Them, Frederic; St-Onge, Judith; Jouan, Thibaud; Chevarin, Martin; Poé, Charlotte; Carmignac, Virginie; Vitobello, Antonio; Callier, Patrick; Rivière, Jean-Baptiste; Faivre, Laurence; Thauvin-Robinet, Christel

2018-06-01

PurposeCongenital anomalies and intellectual disability (CA/ID) are a major diagnostic challenge in medical genetics-50% of patients still have no molecular diagnosis after a long and stressful diagnostic "odyssey." Solo clinical whole-exome sequencing (WES) was applied in our genetics center to improve diagnosis in patients with CA/ID.MethodsThis retrospective study examined 416 consecutive tests performed over 3 years to demonstrate the effectiveness of periodically reanalyzing WES data. The raw data from each nonpositive test was reanalyzed at 12 months with the most recent pipeline and in the light of new data in the literature. The results of the reanalysis for patients enrolled in the third year are not yet available.ResultsOf the 416 patients included, data for 156 without a diagnosis were reanalyzed. We obtained 24 (15.4%) additional diagnoses: 12 through the usual diagnostic process (7 new publications, 4 initially misclassified, and 1 copy-number variant), and 12 through translational research by international data sharing. The final yield of positive results was 27.9% through a strict diagnostic approach, and 2.9% through an additional research strategy.ConclusionThis article highlights the effectiveness of periodically combining diagnostic reinterpretation of clinical WES data with translational research involving data sharing for candidate genes.

[Definition of the Diagnosis Osteomyelitis-Osteomyelitis Diagnosis Score (ODS)].

PubMed

Schmidt, H G K; Tiemann, A H; Braunschweig, R; Diefenbeck, M; Bühler, M; Abitzsch, D; Haustedt, N; Walter, G; Schoop, R; Heppert, V; Hofmann, G O; Glombitza, M; Grimme, C; Gerlach, U-J; Flesch, I

2011-08-01

The disease "osteomyelitis" is characterised by different symptoms and parameters. Decisive roles in the development of the disease are played by the causative bacteria, the route of infection and the individual defense mechanisms of the host. The diagnosis is based on different symptoms and findings from the clinical history, clinical symptoms, laboratory results, diagnostic imaging, microbiological and histopathological analyses. While different osteomyelitis classifications have been published, there is to the best of our knowledge no score that gives information how sure the diagnosis "osteomyelitis" is in general. For any scientific study of a disease a valid definition is essential. We have developed a special osteomyelitis diagnosis score for the reliable classification of clinical, laboratory and technical findings. The score is based on five diagnostic procedures: 1) clinical history and risk factors, 2) clinical examination and laboratory results, 3) diagnostic imaging (ultrasound, radiology, CT, MRI, nuclear medicine and hybrid methods), 4) microbiology, and 5) histopathology. Each diagnostic procedure is related to many individual findings, which are weighted by a score system, in order to achieve a relevant value for each assessment. If the sum of the five diagnostic criteria is 18 or more points, the diagnosis of osteomyelitis can be viewed as "safe" (diagnosis class A). Between 8-17 points the diagnosis is "probable" (diagnosis class B). Less than 8 points means that the diagnosis is "possible, but unlikely" (class C diagnosis). Since each parameter can score six points at a maximum, a reliable diagnosis can only be achieved if at least 3 parameters are scored with 6 points. The osteomyelitis diagnosis score should help to avoid the false description of a clinical presentation as "osteomyelitis". A safe diagnosis is essential for the aetiology, treatment and outcome studies of osteomyelitis. © Georg Thieme Verlag KG Stuttgart · New York.

A data-driven algorithm integrating clinical and laboratory features for the diagnosis and prognosis of necrotizing enterocolitis.

PubMed

Ji, Jun; Ling, Xuefeng B; Zhao, Yingzhen; Hu, Zhongkai; Zheng, Xiaolin; Xu, Zhening; Wen, Qiaojun; Kastenberg, Zachary J; Li, Ping; Abdullah, Fizan; Brandt, Mary L; Ehrenkranz, Richard A; Harris, Mary Catherine; Lee, Timothy C; Simpson, B Joyce; Bowers, Corinna; Moss, R Lawrence; Sylvester, Karl G

2014-01-01

Necrotizing enterocolitis (NEC) is a major source of neonatal morbidity and mortality. Since there is no specific diagnostic test or risk of progression model available for NEC, the diagnosis and outcome prediction of NEC is made on clinical grounds. The objective in this study was to develop and validate new NEC scoring systems for automated staging and prognostic forecasting. A six-center consortium of university based pediatric teaching hospitals prospectively collected data on infants under suspicion of having NEC over a 7-year period. A database comprised of 520 infants was utilized to develop the NEC diagnostic and prognostic models by dividing the entire dataset into training and testing cohorts of demographically matched subjects. Developed on the training cohort and validated on the blind testing cohort, our multivariate analyses led to NEC scoring metrics integrating clinical data. Machine learning using clinical and laboratory results at the time of clinical presentation led to two nec models: (1) an automated diagnostic classification scheme; (2) a dynamic prognostic method for risk-stratifying patients into low, intermediate and high NEC scores to determine the risk for disease progression. We submit that dynamic risk stratification of infants with NEC will assist clinicians in determining the need for additional diagnostic testing and guide potential therapies in a dynamic manner. http://translationalmedicine.stanford.edu/cgi-bin/NEC/index.pl and smartphone application upon request.

Routine Ultrasound and Limited Computed Tomography for the Diagnosis of Acute Appendicitis

PubMed Central

Wiersma, Fraukje; Bakker, Rutger F. R.; Merkus, Jos W. S.; Breslau, Paul J.; Hamming, Jaap F.

2010-01-01

Background Acute appendicitis continues to be a challenging diagnosis. Preoperative radiological imaging using ultrasound (US) or computed tomography (CT) has gained popularity as it may offer a more accurate diagnosis than classic clinical evaluation. The optimal implementation of these diagnostic modalities has yet to be established. The aim of the present study was to investigate a diagnostic pathway that uses routine US, limited CT, and clinical re-evaluation for patients with acute appendicitis. Methods A prospective analysis was performed of all patients presenting with acute abdominal pain at the emergency department from June 2005 until July 2006 using a structured diagnosis and management flowchart. Daily practice was mimicked, while ensuring a valid assessment of clinical and radiological diagnostic accuracies and the effect they had on patient management. Results A total of 802 patients were included in this analysis. Additional radiological imaging was performed in 96.3% of patients with suspected appendicitis (n = 164). Use of CT was kept to a minimum (17.9%), with a US:CT ratio of approximately 6:1. Positive and negative predictive values for the clinical diagnosis of appendicitis were 63 and 98%, respectively; for US 94 and 97%, respectively; and for CT 100 and 100%, respectively. The negative appendicitis rate was 3.3%, the perforation rate was 23.5%, and the missed perforated appendicitis rate was 3.4%. No (diagnostic) laparoscopies were performed. Conclusions A diagnostic pathway using routine US, limited CT, and clinical re-evaluation for patients with acute abdominal pain can provide excellent results for the diagnosis and treatment of appendicitis. PMID:20582544

Diagnosis of Periodontal Diseases: Building a Bridge from Today's Methods to Tomorrow's Technology.

ERIC Educational Resources Information Center

Jeffcoat, Marjorie K.

1994-01-01

A discussion of advancements in diagnosis of periodontal diseases looks first at the screening process, reviews specific periodontal diseases and their clinical signs and symptoms, and explains both traditional and newly developed diagnostic tests. A framework for understanding the tests' clinical usefulness is also presented. (MSE)

Impact of transition from microscopy to molecular screening for detection of intestinal protozoa in Dutch patients.

PubMed

Svraka-Latifovic, S; Bouter, S; Naus, H; Bakker, L J; Timmerman, C P; Dorigo-Zetsma, J W

2014-11-01

Detection of intestinal protozoa by PCR methods has been described as being sensitive and specific, and as improving the diagnostic yield. Here we present the outcome of the transition from microscopy to molecular screening for detection of a select group of intestinal protozoa in faeces in our laboratory. Introduction of molecular screening for intestinal protozoa resulted in higher sensitivity, reduced hands-on-time, reduced time-to-results, leading to improved diagnostic efficiency. © 2014 The Authors Clinical Microbiology and Infection © 2014 European Society of Clinical Microbiology and Infectious Diseases.

Molecular methods for somatic mutation testing in lung adenocarcinoma: EGFR and beyond

PubMed Central

Rogers, Toni-Maree; Fellowes, Andrew; Bell, Anthony; Fox, Stephen

2015-01-01

Somatic mutational profiling in cancer has revolutionized the practice of clinical oncology. The discovery of driver mutations in non-small cell lung cancer (NSCLC) is an example of this. Molecular testing of lung adenocarcinoma is now considered standard of care and part of the diagnostic algorithm. This article provides an overview of the workflow of molecular testing in a clinical diagnostic laboratory discussing in particular novel assays that are currently in use for somatic mutation detection in NSCLC focussing on epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK), ROS1 and RET rearrangements. PMID:25870795

[Differential Diagnosis of Mediastinal and Hilar Lymphadenopathy with Focus on Occupational Diseases].

PubMed

Lux, H; Cavalcante, L Barreira; Baur, X

2018-06-01

Hilar and mediastinal lymphadenopathy may represent a diagnostic challenge in clinical practice. This article is intended to facilitate differential diagnosis by a systematic description of relevant pathologies, notably with occupational etiology. Clinical findings of relevant diseases, i. e. of tuberculosis, chronic beryllium disease, sarcoidosis, lung cancer, malignant lymphoma, Epstein-Barr virus infection, and histoplasmosis are compared.Case history, imaging and laboratory tests have important diagnostic impact. But also invasive methods can be necessary in order to exclude and prove malignancy, infection or autoimmune disease. © Georg Thieme Verlag KG Stuttgart · New York.

Applied Genomics: Data Mining Reveals Species-Specific Malaria Diagnostic Targets More Sensitive than 18S rRNA▿†‡

PubMed Central

Demas, Allison; Oberstaller, Jenna; DeBarry, Jeremy; Lucchi, Naomi W.; Srinivasamoorthy, Ganesh; Sumari, Deborah; Kabanywanyi, Abdunoor M.; Villegas, Leopoldo; Escalante, Ananias A.; Kachur, S. Patrick; Barnwell, John W.; Peterson, David S.; Udhayakumar, Venkatachalam; Kissinger, Jessica C.

2011-01-01

Accurate and rapid diagnosis of malaria infections is crucial for implementing species-appropriate treatment and saving lives. Molecular diagnostic tools are the most accurate and sensitive method of detecting Plasmodium, differentiating between Plasmodium species, and detecting subclinical infections. Despite available whole-genome sequence data for Plasmodium falciparum and P. vivax, the majority of PCR-based methods still rely on the 18S rRNA gene targets. Historically, this gene has served as the best target for diagnostic assays. However, it is limited in its ability to detect mixed infections in multiplex assay platforms without the use of nested PCR. New diagnostic targets are needed. Ideal targets will be species specific, highly sensitive, and amenable to both single-step and multiplex PCRs. We have mined the genomes of P. falciparum and P. vivax to identify species-specific, repetitive sequences that serve as new PCR targets for the detection of malaria. We show that these targets (Pvr47 and Pfr364) exist in 14 to 41 copies and are more sensitive than 18S rRNA when utilized in a single-step PCR. Parasites are routinely detected at levels of 1 to 10 parasites/μl. The reaction can be multiplexed to detect both species in a single reaction. We have examined 7 P. falciparum strains and 91 P. falciparum clinical isolates from Tanzania and 10 P. vivax strains and 96 P. vivax clinical isolates from Venezuela, and we have verified a sensitivity and specificity of ∼100% for both targets compared with a nested 18S rRNA approach. We show that bioinformatics approaches can be successfully applied to identify novel diagnostic targets and improve molecular methods for pathogen detection. These novel targets provide a powerful alternative molecular diagnostic method for the detection of P. falciparum and P. vivax in conventional or multiplex PCR platforms. PMID:21525225

[Pheochromocytoma in 8-year observation at a single endocrinological center in Wroclaw].

PubMed

Bednarek-Tupikowska, Grazyna; Bucyk, Barbara; Daroszewski, Jacek; Bidzińska-Speichert, Bozena; Bohdanowicz-Pawlak, Anna; Szymczak, Jadwiga; Bednorz, Włodzimierz; Podgórski, Franciszek; Zareba-Bogdał, Elzbieta; Kuliczkowska-Płaksej, Justyna; Lenarcik, Agnieszka; Filus, Alicja; Kałuzny, Marcin; Kubicka, Eliza; Syrycka, Joanna; Tupikowska, Małgorzata; Lizurej, Oskar; Bolanowski, Marek; Milewicz, Andrzej

2009-01-01

Pheochromocytoma is rare tumor with a highly variable clinical presentation. This report provides clinical picture, efficiency of diagnostics and treatment of pheochromocytoma in 8-years in the endocrinological center in Wroclaw. The records of 37 patients with pheochromocytoma were identified, who were treated in 2000-2007 in the Department of Endocrinology, Diabetology and Isotope Treatment in Wroclaw. There were 23 women (age 23-75 year) and 14 men (age 17-74). We studied frequency of clinical signs, usefulness of diagnostic methods and efficacy of treatment. The duration of the clinical history ranged from 2 months to 16 years. The most frequent symptoms were: hypertension paroxysmal and constant, palpitations, headache, sweating and anxiety. The most sensitive diagnostic method was increased concentration of urinary metanephrine in 24-hour urine. Computed tomography was the most widely used method for tumor localization. Adrenal pheochromocytoma was detecting by CT in all patients, predominated in right adrenal, in 1 case in urinary bladder. Surgery caused remission of hypertension in 59%, improvement in 26.8%, and no changes in 13.9% of patients. Malignancy was reported in 2 cases, 1 woman died after surgery. MEN 2A occur in 21.6%. The diagnosis of pheochromocytma is usually made after long duration of the disease. The study confirms that clinical presentation of pheochromocytoma is variable and nonspecific, this finding makes the diagnosis very difficult. The most typical symptom is paroxysmal hypertension, which is present only in 40%, other symptoms are nonspecific. The measurement of 24-hour urinary metanephrines was the best indicator. CT was almost always successful in localizing the tumor. Patients with pheochromocytoma should be consider for other endocrine diseases especially medullary carcinoma, primary hyperparathyroidism and other component of MEN 2A.

Prevalence, Clinical Presentation, and Differential Diagnosis of Pediatric Bipolar Disorder

PubMed Central

Goldstein, Benjamin I.; Birmaher, Boris

2016-01-01

Background Over the past 20 years, the evidence regarding pediatric bipolar disorder (BP) has increased substantially. As a result, recent concerns have focused primarily on prevalence and differential diagnosis. Method Selective review of the literature. Results BP as defined by rigorously applying diagnostic criteria has been observed among children and especially adolescents in numerous countries. In contrast to increasing diagnoses in clinical settings, prevalence in epidemiologic studies has not recently changed. BP-spectrum conditions among youth are highly impairing and confer high risk for conversion to BP-I and BP-II. Compared to adults, youth with BP have more mixed symptoms, more changes in mood polarity, are more often symptomatic and seem to have worse prognosis. The course, clinical characteristics, and comorbidities of BP among children and adolescents are in many ways otherwise similar to those of adults with BP. Nonetheless, many youth with BP receive no treatment and most do not receive BP-specific treatment. Conclusion Despite increased evidence supporting the validity of pediatric BP, discrepancies between clinical and epidemiologic findings suggest that diagnostic misapplication may be common. Simultaneously, low rates of treatment of youth with BP suggest that withholding of BP diagnoses may also be common. Clinicians should apply diagnostic criteria rigorously in order to optimize diagnostic accuracy and ensure appropriate treatment. PMID:22652925

Diagnosis and management of dementia with Lewy bodies

PubMed Central

Boeve, Bradley F.; Dickson, Dennis W.; Halliday, Glenda; Taylor, John-Paul; Weintraub, Daniel; Aarsland, Dag; Galvin, James; Attems, Johannes; Ballard, Clive G.; Bayston, Ashley; Beach, Thomas G.; Blanc, Frédéric; Bohnen, Nicolaas; Bonanni, Laura; Bras, Jose; Brundin, Patrik; Burn, David; Chen-Plotkin, Alice; Duda, John E.; El-Agnaf, Omar; Feldman, Howard; Ferman, Tanis J.; ffytche, Dominic; Fujishiro, Hiroshige; Galasko, Douglas; Goldman, Jennifer G.; Gomperts, Stephen N.; Graff-Radford, Neill R.; Honig, Lawrence S.; Iranzo, Alex; Kantarci, Kejal; Kaufer, Daniel; Kukull, Walter; Lee, Virginia M.Y.; Leverenz, James B.; Lewis, Simon; Lippa, Carol; Lunde, Angela; Masellis, Mario; Masliah, Eliezer; McLean, Pamela; Mollenhauer, Brit; Montine, Thomas J.; Moreno, Emilio; Mori, Etsuro; Murray, Melissa; O'Brien, John T.; Orimo, Sotoshi; Postuma, Ronald B.; Ramaswamy, Shankar; Ross, Owen A.; Salmon, David P.; Singleton, Andrew; Taylor, Angela; Thomas, Alan; Tiraboschi, Pietro; Toledo, Jon B.; Trojanowski, John Q.; Tsuang, Debby; Walker, Zuzana; Yamada, Masahito; Kosaka, Kenji

2017-01-01

The Dementia with Lewy Bodies (DLB) Consortium has refined its recommendations about the clinical and pathologic diagnosis of DLB, updating the previous report, which has been in widespread use for the last decade. The revised DLB consensus criteria now distinguish clearly between clinical features and diagnostic biomarkers, and give guidance about optimal methods to establish and interpret these. Substantial new information has been incorporated about previously reported aspects of DLB, with increased diagnostic weighting given to REM sleep behavior disorder and 123iodine-metaiodobenzylguanidine (MIBG) myocardial scintigraphy. The diagnostic role of other neuroimaging, electrophysiologic, and laboratory investigations is also described. Minor modifications to pathologic methods and criteria are recommended to take account of Alzheimer disease neuropathologic change, to add previously omitted Lewy-related pathology categories, and to include assessments for substantia nigra neuronal loss. Recommendations about clinical management are largely based upon expert opinion since randomized controlled trials in DLB are few. Substantial progress has been made since the previous report in the detection and recognition of DLB as a common and important clinical disorder. During that period it has been incorporated into DSM-5, as major neurocognitive disorder with Lewy bodies. There remains a pressing need to understand the underlying neurobiology and pathophysiology of DLB, to develop and deliver clinical trials with both symptomatic and disease-modifying agents, and to help patients and carers worldwide to inform themselves about the disease, its prognosis, best available treatments, ongoing research, and how to get adequate support. PMID:28592453

Precise Detection of IDH1/2 and BRAF Hotspot Mutations in Clinical Glioma Tissues by a Differential Calculus Analysis of High-Resolution Melting Data

PubMed Central

Hatae, Ryusuke; Yoshimoto, Koji; Kuga, Daisuke; Akagi, Yojiro; Murata, Hideki; Suzuki, Satoshi O.; Mizoguchi, Masahiro; Iihara, Koji

2016-01-01

High resolution melting (HRM) is a simple and rapid method for screening mutations. It offers various advantages for clinical diagnostic applications. Conventional HRM analysis often yields equivocal results, especially for surgically obtained tissues. We attempted to improve HRM analyses for more effective applications to clinical diagnostics. HRM analyses were performed for IDH1R132 and IDH2R172 mutations in 192 clinical glioma samples in duplicate and these results were compared with sequencing results. BRAFV600E mutations were analyzed in 52 additional brain tumor samples. The melting profiles were used for differential calculus analyses. Negative second derivative plots revealed additional peaks derived from heteroduplexes in PCR products that contained mutations; this enabled unequivocal visual discrimination of the mutations. We further developed a numerical expression, the HRM-mutation index (MI), to quantify the heteroduplex-derived peak of the mutational curves. Using this expression, all IDH1 mutation statuses matched those ascertained by sequencing, with the exception of three samples. These discordant results were all derived from the misinterpretation of sequencing data. The effectiveness of our approach was further validated by analyses of IDH2R172 and BRAFV600E mutations. The present analytical method enabled an unequivocal and objective HRM analysis and is suitable for reliable mutation scanning in surgically obtained glioma tissues. This approach could facilitate molecular diagnostics in clinical environments. PMID:27529619

Usefulness of component resolved analysis of cat allergy in routine clinical practice.

PubMed

Eder, Katharina; Becker, Sven; San Nicoló, Marion; Berghaus, Alexander; Gröger, Moritz

2016-01-01

Cat allergy is of great importance, and its prevalence is increasing worldwide. Cat allergens and house dust mite allergens represent the major indoor allergens; however, they are ubiquitous. Cat sensitization and allergy are known risk factors for rhinitis, bronchial hyperreactivity and asthma. Thus, the diagnosis of sensitization to cats is important for any allergist. 70 patients with positive skin prick tests for cats were retrospectively compared regarding their skin prick test results, as well as their specific immunoglobulin E antibody profiles with regard to their responses to the native cat extract, rFel d 1, nFel d 2 and rFel d 4. 35 patients were allergic to cats, as determined by positive anamnesis and/or nasal provocation with cat allergens, and 35 patients exhibited clinically non-relevant sensitization, as indicated by negative anamnesis and/or a negative nasal allergen challenge. Native cat extract serology testing detected 100% of patients who were allergic to cats but missed eight patients who showed sensitization in the skin prick test and did not have allergic symptoms. The median values of the skin prick test, as well as those of the specific immunoglobulin E antibodies against the native cat extract, were significantly higher for allergic patients than for patients with clinically non-relevant sensitization. Component based diagnostic testing to rFel d 1 was not as reliable. Sensitization to nFel d 2 and rFel d 4 was seen only in individual patients. Extract based diagnostic methods for identifying cat allergy and sensitization, such as the skin prick test and native cat extract serology, remain crucial in routine clinical practice. In our study, component based diagnostic testing could not replace these methods with regard to the detection of sensitization to cats and differentiation between allergy and sensitization without clinical relevance. However, component resolved allergy diagnostic tools have individual implications, and future studies may facilitate a better understanding of its use and subsequently may improve the clinical management of allergic patients.

42 CFR 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Code of Federal Regulations, 2014 CFR

2014-10-01

.... Nonphysician practitioners (that is, clinical nurse specialists, clinical psychologists, clinical social... that do not involve the use of contrast media; and (iii) Diagnostic mammograms if the approved portable...

MALDI TOF imaging mass spectrometry in clinical pathology: a valuable tool for cancer diagnostics (review).

PubMed

Kriegsmann, Jörg; Kriegsmann, Mark; Casadonte, Rita

2015-03-01

Matrix-assisted laser desorption/ionization (MALDI) time-of-flight (TOF) imaging mass spectrometry (IMS) is an evolving technique in cancer diagnostics and combines the advantages of mass spectrometry (proteomics), detection of numerous molecules, and spatial resolution in histological tissue sections and cytological preparations. This method allows the detection of proteins, peptides, lipids, carbohydrates or glycoconjugates and small molecules.Formalin-fixed paraffin-embedded tissue can also be investigated by IMS, thus, this method seems to be an ideal tool for cancer diagnostics and biomarker discovery. It may add information to the identification of tumor margins and tumor heterogeneity. The technique allows tumor typing, especially identification of the tumor of origin in metastatic tissue, as well as grading and may provide prognostic information. IMS is a valuable method for the identification of biomarkers and can complement histology, immunohistology and molecular pathology in various fields of histopathological diagnostics, especially with regard to identification and grading of tumors.

The use of biomarkers and molecular methods for the earlier diagnosis of invasive aspergillosis in immunocompromised patients.

PubMed

Ambasta, Anshula; Carson, Julie; Church, Deirdre L

2015-08-01

Invasive aspergillosis (IA) is an opportunistic infection that is often life threatening in the immunocompromised host. Early diagnosis is critical, especially given the efficacy and availability of several new anti-fungal therapies. Current (2008) diagnostic criteria have limited ability to detect early infection and are aimed at establishing disease. Although histopathology and culture techniques have traditionally been used to make a proven diagnosis of IA, their dependence on tissue samples and slow turnaround times hamper early confirmation of IA. Serologic detection of circulating galactomannan and 1,3-β-D-glucan fungal biomarkers show promise for improving the diagnosis of IA, and their use is included in the EORTC/MSG diagnostic criteria for IA. Numerous studies have evaluated the diagnostic performance of these two biomarkers and shown that they have suboptimal sensitivity when used alone for early diagnosis of proven IA. Currently available molecular assays also suffer from a lack of standardization. Evaluation of the use of different combinations of test methods to enhance diagnostic accuracy is also being done but prompt, accurate diagnosis of IA remains a clinical and diagnostic challenge. The clinical validity and limitations of biomarkers and current molecular methods for the early diagnosis of IA are summarized in this review with respect to the different patient populations at risk for this serious infection. © The Author 2015. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Clinical Outcomes and Cost Effectiveness of Accelerated Diagnostic Protocol in a Chest Pain Center Compared with Routine Care of Patients with Chest Pain

PubMed Central

Asher, Elad; Reuveni, Haim; Shlomo, Nir; Gerber, Yariv; Beigel, Roy; Narodetski, Michael; Eldar, Michael; Or, Jacob; Hod, Hanoch; Shamiss, Arie; Matetzky, Shlomi

2015-01-01

Aims The aim of this study was to compare in patients presenting with acute chest pain the clinical outcomes and cost-effectiveness of an accelerated diagnostic protocol utilizing contemporary technology in a chest pain unit versus routine care in an internal medicine department. Methods and Results Hospital and 90-day course were prospectively studied in 585 consecutive low-moderate risk acute chest pain patients, of whom 304 were investigated in a designated chest pain center using a pre-specified accelerated diagnostic protocol, while 281 underwent routine care in an internal medicine ward. Hospitalization was longer in the routine care compared with the accelerated diagnostic protocol group (p<0.001). During hospitalization, 298 accelerated diagnostic protocol patients (98%) vs. 57 (20%) routine care patients underwent non-invasive testing, (p<0.001). Throughout the 90-day follow-up, diagnostic imaging testing was performed in 125 (44%) and 26 (9%) patients in the routine care and accelerated diagnostic protocol patients, respectively (p<0.001). Ultimately, most patients in both groups had non-invasive imaging testing. Accelerated diagnostic protocol patients compared with those receiving routine care was associated with a lower incidence of readmissions for chest pain [8 (3%) vs. 24 (9%), p<0.01], and acute coronary syndromes [1 (0.3%) vs. 9 (3.2%), p<0.01], during the follow-up period. The accelerated diagnostic protocol remained a predictor of lower acute coronary syndromes and readmissions after propensity score analysis [OR = 0.28 (CI 95% 0.14–0.59)]. Cost per patient was similar in both groups [($2510 vs. $2703 for the accelerated diagnostic protocol and routine care group, respectively, (p = 0.9)]. Conclusion An accelerated diagnostic protocol is clinically superior and as cost effective as routine in acute chest pain patients, and may save time and resources. PMID:25622029

Potential Clinical Impact of The Filmarray Meningitis Encephalitis Panel In Children With Suspected Central Nervous System Infections

PubMed Central

Messacar, Kevin; Breazeale, Garrett; Robinson, Christine C.; Dominguez, Samuel R.

2016-01-01

The FilmArray Meningitis Encephalitis Panel, a multiplex PCR for testing of cerebrospinal fluid, was compared to conventional diagnostic methods in children with suspected central nervous system infections. The panel had comparable diagnostic yield (96% agreement) and improved time-to-diagnosis by 10.3 hours with potential for more judicious antimicrobial use, particularly acyclovir. PMID:27342782

Upper Extremity Injuries in Tennis Players: Diagnosis, Treatment, and Management

PubMed Central

Chung, Kevin C.; Lark, Meghan E.

2016-01-01

Synopsis Upper extremity tennis injuries are most commonly characterized as overuse injuries to the wrist, elbow and shoulder. The complex anatomy of these structures and their interaction with biomechanical properties of tennis strokes contributes to the diagnostic challenges. A thorough understanding of tennis kinetics, in combination with the current literature surrounding diagnostic and treatment methods, will improve clinical decision-making. PMID:27886833

LSTM for diagnosis of neurodegenerative diseases using gait data

NASA Astrophysics Data System (ADS)

Zhao, Aite; Qi, Lin; Li, Jie; Dong, Junyu; Yu, Hui

2018-04-01

Neurodegenerative diseases (NDs) usually cause gait disorders and postural disorders, which provides an important basis for NDs diagnosis. By observing and analyzing these clinical manifestations, medical specialists finally give diagnostic results to the patient, which is inefficient and can be easily affected by doctors' subjectivity. In this paper, we propose a two-layer Long Short-Term Memory (LSTM) model to learn the gait patterns exhibited in the three NDs. The model was trained and tested using temporal data that was recorded by force-sensitive resistors including time series, such as stride interval and swing interval. Our proposed method outperforms other methods in literature in accordance with accuracy of the predicted diagnostic result. Our approach aims at providing the quantitative assessment so that to indicate the diagnosis and treatment of these neurodegenerative diseases in clinic

Region of interest processing for iterative reconstruction in x-ray computed tomography

NASA Astrophysics Data System (ADS)

Kopp, Felix K.; Nasirudin, Radin A.; Mei, Kai; Fehringer, Andreas; Pfeiffer, Franz; Rummeny, Ernst J.; Noël, Peter B.

2015-03-01

The recent advancements in the graphics card technology raised the performance of parallel computing and contributed to the introduction of iterative reconstruction methods for x-ray computed tomography in clinical CT scanners. Iterative maximum likelihood (ML) based reconstruction methods are known to reduce image noise and to improve the diagnostic quality of low-dose CT. However, iterative reconstruction of a region of interest (ROI), especially ML based, is challenging. But for some clinical procedures, like cardiac CT, only a ROI is needed for diagnostics. A high-resolution reconstruction of the full field of view (FOV) consumes unnecessary computation effort that results in a slower reconstruction than clinically acceptable. In this work, we present an extension and evaluation of an existing ROI processing algorithm. Especially improvements for the equalization between regions inside and outside of a ROI are proposed. The evaluation was done on data collected from a clinical CT scanner. The performance of the different algorithms is qualitatively and quantitatively assessed. Our solution to the ROI problem provides an increase in signal-to-noise ratio and leads to visually less noise in the final reconstruction. The reconstruction speed of our technique was observed to be comparable with other previous proposed techniques. The development of ROI processing algorithms in combination with iterative reconstruction will provide higher diagnostic quality in the near future.

Divergences between clinical and research methods for assessing personality disorders: implications for research and the evolution of axis II.

PubMed

Westen, D

1997-07-01

The purpose of this study was to examine the extent to which instruments for assessing axis II diverge from clinical diagnostic processes. Subjects in the first study were 52 clinicians with experience in assessment and treatment of patients with personality disorders, who were surveyed about the methods they use in clinical practice to make diagnoses and other aspects of the diagnostic process. A second study replicated the major findings with a random national sample of 1,901 experienced psychiatrists and psychologists. Whereas current instruments rely primarily on direct questions derived from DSM-IV, clinicians of every theoretical persuasion found direct questions useful for assessing axis I disorders but only marginally so for axis II. They made axis II diagnoses, instead, by listening to patients describe interpersonal interactions and observing their behavior with the interviewer. In contrast to findings with current research instruments, most patients with personality disorders in clinical practice receive only one axis II diagnosis, and if they receive more than one, one is considered primary. Clinicians reported treating a substantial number of patients for enduring personality patterns that current axis II instruments do not assess, many of which meet neither axis I nor axis II criteria, notably problems with relatedness, work, self-esteem, and chronic subclinical depressive traits. Measurements of axis II were constructed by using a model derived from axis I instruments that diverges from clinical diagnostic procedures in a way that may be problematic for the assessment of personality disorders and the development of a more clinically and empirically sound taxonomy.

Diagnostic imaging of the nasolacrimal drainage system. Part I. Radiological anatomy of lacrimal pathways. Physiology of tear secretion and tear outflow.

PubMed

Maliborski, Artur; Różycki, Radosław

2014-04-17

Excessive watering of the eye is a common condition in ophthalmological practice. It may be the result of excessive production of tear fluid or obstruction and insufficiency of efferent tear pathways. The differentiation between obstruction and insufficiency of the lacrimal pathways is still clinically questionable. In the diagnostic process it is necessary to perform clinical tests and additional diagnostic imaging is often needed. Dacryocystography, with or without the extension of the dynamic phase or subtraction option, still remains the criterion standard for diagnostic imaging of the lacrimal obstruction. It may help to clarify the cause and exact place of the obstruction and provide information for further management, especially surgical treatment. Increasingly, new techniques are used in diagnostic imaging of the lacrimal tract, such as computed tomography, magnetic resonance, and isotopic methods. Adequate knowledge of the anatomy and physiology of the lacrimal system and the secretion and outflow of tears is the basis for proper diagnostic imaging. The purpose of this paper is to present the exact anatomy of the lacrimal system, with particular emphasis on the radiological anatomy and the current state of knowledge about the physiology of tear secretion and drainage.

Diagnostic Crossover in Anorexia Nervosa and Bulimia Nervosa: Implications for DSM-V

PubMed Central

Eddy, Kamryn T.; Dorer, David J.; Franko, Debra L.; Tahilani, Kavita; Thompson-Brenner, Heather; Herzog, David B.

2011-01-01

Objective The Diagnostic and Statistical Manual of Mental Disorders (DSM) is designed primarily as a clinical tool. Yet high rates of diagnostic “crossover” among the anorexia nervosa subtypes and bulimia nervosa may reflect problems with the validity of the current diagnostic schema, thereby limiting its clinical utility. This study was designed to examine diagnostic crossover longitudinally in anorexia nervosa and bulimia nervosa to inform the validity of the DSM-IV-TR eating disorders classification system. Method A total of 216 women with a diagnosis of anorexia nervosa or bulimia nervosa were followed for 7 years; weekly eating disorder symptom data collected using the Eating Disorder Longitudinal Interval Follow-Up Examination allowed for diagnoses to be made throughout the follow-up period. Results Over 7 years, the majority of women with anorexia nervosa experienced diagnostic crossover: more than half crossed between the restricting and binge eating/purging anorexia nervosa subtypes over time; one-third crossed over to bulimia nervosa but were likely to relapse into anorexia nervosa. Women with bulimia nervosa were unlikely to cross over to anorexia nervosa. Conclusions These findings support the longitudinal distinction of anorexia nervosa and bulimia nervosa but do not support the anorexia nervosa subtyping schema. PMID:18198267

Quantum Dots for Molecular Diagnostics of Tumors

PubMed Central

Zdobnova, T.A.; Lebedenko, E.N.; Deyev, S.М.

2011-01-01

Semiconductor quantum dots (QDs) are a new class of fluorophores with unique physical and chemical properties, which allow to appreciably expand the possibilities for the current methods of fluorescent imaging and optical diagnostics. Here we discuss the prospects of QD application for molecular diagnostics of tumors ranging from cancer-specific marker detection on microplates to non-invasive tumor imagingin vivo. We also point out the essential problems that require resolution in order to clinically promote QD, and we indicate innovative approaches to oncology which are implementable using QD. PMID:22649672

[Peculiarities of the early diagnostics of malignant nasopharyngal neoplasms].

PubMed

Baryshev, V V; Andreev, V G; Sevryukov, F E; Buyakova, M E; Akki, E D

The authors consider the risk factors and the specific clinical symptoms of the malignant nasopharyngal neoplasms as well as the methods for instrumental, laboratory, and pathomorphological diagnostics of this pathology. The full scale implementation of the recommendations for the timely detection of the tumours using the aforementioned diagnostic procedures and tests makes it possible to reduce to a minimum the interval between the establishment of the diagnosis and the onset of the relevant treatment at the early stages of the disease and thereby to ensure the improvement of its long-term outcomes.

42 CFR 414.506 - Procedures for public consultation for payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2010 CFR

2010-10-01

... a new clinical diagnostic laboratory test. 414.506 Section 414.506 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory test...

42 CFR 414.506 - Procedures for public consultation for payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2011 CFR

2011-10-01

... a new clinical diagnostic laboratory test. 414.506 Section 414.506 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory test...

Validation of next generation sequencing technologies in comparison to current diagnostic gold standards for BRAF, EGFR and KRAS mutational analysis.

PubMed

McCourt, Clare M; McArt, Darragh G; Mills, Ken; Catherwood, Mark A; Maxwell, Perry; Waugh, David J; Hamilton, Peter; O'Sullivan, Joe M; Salto-Tellez, Manuel

2013-01-01

Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical diagnosis and therapeutic decision-making in oncology owing to its enhanced sensitivity in DNA mutation detection, fast-turnaround of samples in comparison to current gold standard methods and the potential to sequence a large number of cancer-driving genes at the one time. We aim to test the diagnostic accuracy of current NGS technology in the analysis of mutations that represent current standard-of-care, and its reliability to generate concomitant information on other key genes in human oncogenesis. Thirteen clinical samples (8 lung adenocarcinomas, 3 colon carcinomas and 2 malignant melanomas) already genotyped for EGFR, KRAS and BRAF mutations by current standard-of-care methods (Sanger Sequencing and q-PCR), were analysed for detection of mutations in the same three genes using two NGS platforms and an additional 43 genes with one of these platforms. The results were analysed using closed platform-specific proprietary bioinformatics software as well as open third party applications. Our results indicate that the existing format of the NGS technology performed well in detecting the clinically relevant mutations stated above but may not be reliable for a broader unsupervised analysis of the wider genome in its current design. Our study represents a diagnostically lead validation of the major strengths and weaknesses of this technology before consideration for diagnostic use.

Feasibility of streamlining an interactive Bayesian-based diagnostic support tool designed for clinical practice

NASA Astrophysics Data System (ADS)

Chen, Po-Hao; Botzolakis, Emmanuel; Mohan, Suyash; Bryan, R. N.; Cook, Tessa

2016-03-01

In radiology, diagnostic errors occur either through the failure of detection or incorrect interpretation. Errors are estimated to occur in 30-35% of all exams and contribute to 40-54% of medical malpractice litigations. In this work, we focus on reducing incorrect interpretation of known imaging features. Existing literature categorizes cognitive bias leading a radiologist to an incorrect diagnosis despite having correctly recognized the abnormal imaging features: anchoring bias, framing effect, availability bias, and premature closure. Computational methods make a unique contribution, as they do not exhibit the same cognitive biases as a human. Bayesian networks formalize the diagnostic process. They modify pre-test diagnostic probabilities using clinical and imaging features, arriving at a post-test probability for each possible diagnosis. To translate Bayesian networks to clinical practice, we implemented an entirely web-based open-source software tool. In this tool, the radiologist first selects a network of choice (e.g. basal ganglia). Then, large, clearly labeled buttons displaying salient imaging features are displayed on the screen serving both as a checklist and for input. As the radiologist inputs the value of an extracted imaging feature, the conditional probabilities of each possible diagnosis are updated. The software presents its level of diagnostic discrimination using a Pareto distribution chart, updated with each additional imaging feature. Active collaboration with the clinical radiologist is a feasible approach to software design and leads to design decisions closely coupling the complex mathematics of conditional probability in Bayesian networks with practice.

Clinical neurophysiology and quantitative sensory testing in the investigation of orofacial pain and sensory function.

PubMed

Jääskeläinen, Satu K

2004-01-01

Chronic orofacial pain represents a diagnostic and treatment challenge for the clinician. Some conditions, such as atypical facial pain, still lack proper diagnostic criteria, and their etiology is not known. The recent development of neurophysiological methods and quantitative sensory testing for the examination of the trigeminal somatosensory system offers several tools for diagnostic and etiological investigation of orofacial pain. This review presents some of these techniques and the results of their application in studies on orofacial pain and sensory dysfunction. Clinical neurophysiological investigation has greater diagnostic accuracy and sensitivity than clinical examination in the detection of the neurogenic abnormalities of either peripheral or central origin that may underlie symptoms of orofacial pain and sensory dysfunction. Neurophysiological testing may also reveal trigeminal pathology when magnetic resonance imaging has failed to detect it, so these methods should be considered complementary to each other in the investigation of orofacial pain patients. The blink reflex, corneal reflex, jaw jerk, sensory neurography of the inferior alveolar nerve, and the recording of trigeminal somatosensory-evoked potentials with near-nerve stimulation have all proved to be sensitive and reliable in the detection of dysfunction of the myelinated sensory fibers of the trigeminal nerve or its central connections within the brainstem. With appropriately small thermodes, thermal quantitative sensory testing is useful for the detection of trigeminal small-fiber dysfunction (Adelta and C). In neuropathic conditions, it is most sensitive to lesions causing axonal injury. By combining different techniques for investigation of the trigeminal system, an accurate topographical diagnosis and profile of sensory fiber pathology can be determined. Neurophysiological and quantitative sensory tests have already highlighted some similarities among various orofacial pain conditions and have shown heterogeneity within clinical diagnostic categories. With the aid of neurophysiological recordings and quantitative sensory testing, it is possible to approach a mechanism-based classification of orofacial pain.

Quantifying the quality of medical x-ray images: An evaluation based on normal anatomy for lumbar spine and chest radiography

NASA Astrophysics Data System (ADS)

Tingberg, Anders Martin

Optimisation in diagnostic radiology requires accurate methods for determination of patient absorbed dose and clinical image quality. Simple methods for evaluation of clinical image quality are at present scarce and this project aims at developing such methods. Two methods are used and further developed; fulfillment of image criteria (IC) and visual grading analysis (VGA). Clinical image quality descriptors are defined based on these two methods: image criteria score (ICS) and visual grading analysis score (VGAS), respectively. For both methods the basis is the Image Criteria of the ``European Guidelines on Quality Criteria for Diagnostic Radiographic Images''. Both methods have proved to be useful for evaluation of clinical image quality. The two methods complement each other: IC is an absolute method, which means that the quality of images of different patients and produced with different radiographic techniques can be compared with each other. The separating power of IC is, however, weaker than that of VGA. VGA is the best method for comparing images produced with different radiographic techniques and has strong separating power, but the results are relative, since the quality of an image is compared to the quality of a reference image. The usefulness of the two methods has been verified by comparing the results from both of them with results from a generally accepted method for evaluation of clinical image quality, receiver operating characteristics (ROC). The results of the comparison between the two methods based on visibility of anatomical structures and the method based on detection of pathological structures (free-response forced error) indicate that the former two methods can be used for evaluation of clinical image quality as efficiently as the method based on ROC. More studies are, however, needed for us to be able to draw a general conclusion, including studies of other organs, using other radiographic techniques, etc. The results of the experimental evaluation of clinical image quality are compared with physical quantities calculated with a theoretical model based on a voxel phantom, and correlations are found. The results demonstrate that the computer model can be a useful toot in planning further experimental studies.

Decision support in psychiatry – a comparison between the diagnostic outcomes using a computerized decision support system versus manual diagnosis

PubMed Central

Bergman, Lars G; Fors, Uno GH

2008-01-01

Background Correct diagnosis in psychiatry may be improved by novel diagnostic procedures. Computerized Decision Support Systems (CDSS) are suggested to be able to improve diagnostic procedures, but some studies indicate possible problems. Therefore, it could be important to investigate CDSS systems with regard to their feasibility to improve diagnostic procedures as well as to save time. Methods This study was undertaken to compare the traditional 'paper and pencil' diagnostic method SCID1 with the computer-aided diagnostic system CB-SCID1 to ascertain processing time and accuracy of diagnoses suggested. 63 clinicians volunteered to participate in the study and to solve two paper-based cases using either a CDSS or manually. Results No major difference between paper and pencil and computer-supported diagnosis was found. Where a difference was found it was in favour of paper and pencil. For example, a significantly shorter time was found for paper and pencil for the difficult case, as compared to computer support. A significantly higher number of correct diagnoses were found in the diffilt case for the diagnosis 'Depression' using the paper and pencil method. Although a majority of the clinicians found the computer method supportive and easy to use, it took a longer time and yielded fewer correct diagnoses than with paper and pencil. Conclusion This study could not detect any major difference in diagnostic outcome between traditional paper and pencil methods and computer support for psychiatric diagnosis. Where there were significant differences, traditional paper and pencil methods were better than the tested CDSS and thus we conclude that CDSS for diagnostic procedures may interfere with diagnosis accuracy. A limitation was that most clinicians had not previously used the CDSS system under study. The results of this study, however, confirm that CDSS development for diagnostic purposes in psychiatry has much to deal with before it can be used for routine clinical purposes. PMID:18261222

Electronic decision support for diagnostic imaging in a primary care setting

PubMed Central

Reed, Martin H

2011-01-01

Methods Clinical guideline adherence for diagnostic imaging (DI) and acceptance of electronic decision support in a rural community family practice clinic was assessed over 36 weeks. Physicians wrote 904 DI orders, 58% of which were addressed by the Canadian Association of Radiologists guidelines. Results Of those orders with guidelines, 76% were ordered correctly; 24% were inappropriate or unnecessary resulting in a prompt from clinical decision support. Physicians followed suggestions from decision support to improve their DI order on 25% of the initially inappropriate orders. The use of decision support was not mandatory, and there were significant variations in use rate. Initially, 40% reported decision support disruptive in their work flow, which dropped to 16% as physicians gained experience with the software. Conclusions Physicians supported the concept of clinical decision support but were reluctant to change clinical habits to incorporate decision support into routine work flow. PMID:21486884

Brain collection, standardized neuropathologic assessment, and comorbidity in ADNI participants

PubMed Central

Franklin, Erin E.; Perrin, Richard J.; Vincent, Benjamin; Baxter, Michael; Morris, John C.; Cairns, Nigel J.

2015-01-01

Introduction The Alzheimer’s Disease Neuroimaging Initiative Neuropathology Core (ADNI-NPC) facilitates brain donation, ensures standardized neuropathologic assessments, and maintains a tissue resource for research. Methods The ADNI-NPC coordinates with performance sites to promote autopsy consent, facilitate tissue collection and autopsy administration, and arrange sample delivery to the NPC, for assessment using NIA-AA neuropathologic diagnostic criteria. Results The ADNI-NPC has obtained 45 participant specimens and neuropathologic assessments have been completed in 36 to date. Challenges in obtaining consent at some sites have limited the voluntary autopsy rate to 58%. Among assessed cases, clinical diagnostic accuracy for Alzheimer disease (AD) is 97%; however, 58% show neuropathologic comorbidities. Discussion Challenges facing autopsy consent and coordination are largely resource-related. The neuropathologic assessments indicate that ADNI’s clinical diagnostic accuracy for AD is high; however, many AD cases have comorbidities that may impact the clinical presentation, course, and imaging and biomarker results. These neuropathologic data permit multimodal and genetic studies of these comorbidities to improve diagnosis and provide etiologic insights. PMID:26194314

42 CFR 414.509 - Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2010 CFR

2010-10-01

... for a new clinical diagnostic laboratory test. 414.509 Section 414.509 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.509 Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory...

Impact of Data-driven Respiratory Gating in Clinical PET.

PubMed

Büther, Florian; Vehren, Thomas; Schäfers, Klaus P; Schäfers, Michael

2016-10-01

Purpose To study the feasibility and impact of respiratory gating in positron emission tomographic (PET) imaging in a clinical trial comparing conventional hardware-based gating with a data-driven approach and to describe the distribution of determined parameters. Materials and Methods This prospective study was approved by the ethics committee of the University Hospital of Münster (AZ 2014-217-f-N). Seventy-four patients suspected of having abdominal or thoracic fluorine 18 fluorodeoxyglucose (FDG)-positive lesions underwent clinical whole-body FDG PET/computed tomographic (CT) examinations. Respiratory gating was performed by using a pressure-sensitive belt system (belt gating [BG]) and an automatic data-driven approach (data-driven gating [DDG]). PET images were analyzed for lesion uptake, metabolic volumes, respiratory shifts of lesions, and diagnostic image quality. Results Forty-eight patients had at least one lesion in the field of view, resulting in a total of 164 lesions analyzed (range of number of lesions per patient, one to 13). Both gating methods revealed respiratory shifts of lesions (4.4 mm ± 3.1 for BG vs 4.8 mm ± 3.6 for DDG, P = .76). Increase in uptake of the lesions compared with nongated values did not differ significantly between both methods (maximum standardized uptake value [SUVmax], +7% ± 13 for BG vs +8% ± 16 for DDG, P = .76). Similarly, gating significantly decreased metabolic lesion volumes with both methods (-6% ± 26 for BG vs -7% ± 21 for DDG, P = .44) compared with nongated reconstructions. Blinded reading revealed significant improvements in diagnostic image quality when using gating, without significant differences between the methods (DDG was judged to be inferior to BG in 22 cases, equal in 12 cases, and superior in 15 cases; P = .32). Conclusion Respiratory gating increases diagnostic image quality and uptake values and decreases metabolic volumes compared with nongated acquisitions. Data-driven approaches are clinically applicable alternatives to belt-based methods and might help establishing routine respiratory gating in clinical PET/CT. (©) RSNA, 2016 Online supplemental material is available for this article.

Using qualitative research to inform development of a diagnostic algorithm for UTI in children.

PubMed

de Salis, Isabel; Whiting, Penny; Sterne, Jonathan A C; Hay, Alastair D

2013-06-01

Diagnostic and prognostic algorithms can help reduce clinical uncertainty. The selection of candidate symptoms and signs to be measured in case report forms (CRFs) for potential inclusion in diagnostic algorithms needs to be comprehensive, clearly formulated and relevant for end users. To investigate whether qualitative methods could assist in designing CRFs in research developing diagnostic algorithms. Specifically, the study sought to establish whether qualitative methods could have assisted in designing the CRF for the Health Technology Association funded Diagnosis of Urinary Tract infection in Young children (DUTY) study, which will develop a diagnostic algorithm to improve recognition of urinary tract infection (UTI) in children aged <5 years presenting acutely unwell to primary care. Qualitative methods were applied using semi-structured interviews of 30 UK doctors and nurses working with young children in primary care and a Children's Emergency Department. We elicited features that clinicians believed useful in diagnosing UTI and compared these for presence or absence and terminology with the DUTY CRF. Despite much agreement between clinicians' accounts and the DUTY CRFs, we identified a small number of potentially important symptoms and signs not included in the CRF and some included items that could have been reworded to improve understanding and final data analysis. This study uniquely demonstrates the role of qualitative methods in the design and content of CRFs used for developing diagnostic (and prognostic) algorithms. Research groups developing such algorithms should consider using qualitative methods to inform the selection and wording of candidate symptoms and signs.

Use of Electromagnetic Navigational Transthoracic Needle Aspiration (E-TTNA) for Sampling of Lung Nodules.

PubMed

Arias, Sixto; Lee, Hans; Semaan, Roy; Frimpong, Bernice; Ortiz, Ricardo; Feller-Kopman, David; Oakjones-Burgess, Karen; Yarmus, Lonny

2015-05-23

Lung nodule evaluation represents a clinical challenge especially in patients with intermediate risk for malignancy. Multiple technologies are presently available to sample nodules for pathological diagnosis. Those technologies can be divided into bronchoscopic and non-bronchoscopic interventions. Electromagnetic navigational bronchoscopy is being extensively used for the endobronchial approach to peripheral lung nodules but has been hindered by anatomic challenges resulting in a 70% diagnostic yield. Electromagnetic navigational guided transthoracic needle lung biopsy is novel non-bronchoscopic method that uses a percutaneous electromagnetic tip tracked needle to obtain core biopsy specimens. Electromagnetic navigational transthoracic needle aspiration complements bronchoscopic techniques potentially allowing the provider to maximize the diagnostic yield during one single procedure. This article describes a novel integrated diagnostic approach to pulmonary lung nodules. We propose the use of endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) for mediastinal staging; radial EBUS, navigational bronchoscopy and E-TTNA during one single procedure to maximize diagnostic yield and minimize the number of invasive procedures needed to obtain a diagnosis. This manuscript describes in detail how the navigation transthoracic procedure is performed. Additional clinical studies are needed to determine the clinical utility of this novel technology.

Development of Multiplex Reverse Transcription-Polymerase Chain Reaction for Simultaneous Detection of Influenza A, B and Adenoviruses

PubMed Central

Nakhaie, Mohsen; Soleimanjahi, Hoorieh; Mollaie, Hamid Reza; Arabzadeh, Seyed Mohamad Ali

2018-01-01

Background and objective: Millions of people in developing countries lose their lives due to acute respiratory infections, such as Influenza A & B and Adeno viruses. Given the importance of rapid identification of the virus, in this study the researchers attempted to design a method that enables detection of influenza A, B, and adenoviruses, quickly and simultaneously. The Multiplex RT PCR method was the preferred method for the detection of influenza A, B, and adenoviruses in clinical specimens because it is rapid, sensitive, specific, and more cost-effective than alternative methods Methods: After collecting samples from patients with respiratory disease, virus genome was extracted, then Monoplex PCR was used on positive samples and Multiplex RT-PCR on clinical specimens. Finally, by comparing the bands of these samples, the type of virus in the clinical samples was determined. Results: Performing Multiplex RT-PCR on 50 samples of respiratory tract led to following results; flu A: 12.5%, fluB: 50%, adeno: 27.5%, negative: 7.5%, and 2.5% contamination. Conclusion: Reverse transcription-multiplex Polymerase Chain Reaction (PCR) technique, a rapid diagnostic tool, has potential for high-throughput testing. This method has a significant advantage, which provides simultaneous amplification of numerous viruses in a single reaction. This study concentrates on multiplex molecular technologies and their clinical application for the detection and quantification of respiratory pathogens. The improvement in diagnostic testing for viral respiratory pathogens effects patient management, and leads to more cost-effective delivery of care. It limits unnecessary antibiotic use and improves clinical management by use of suitable treatment. PMID:29731796

Challenges to Global Implementation of Infrared Thermography Technology: Current Perspective

PubMed Central

Shterenshis, Michael

2017-01-01

Medical infrared thermography (IT) produces an image of the infrared waves emitted by the human body as part of the thermoregulation process that can vary in intensity based on the health of the person. This review analyzes recent developments in the use of infrared thermography as a screening and diagnostic tool in clinical and nonclinical settings, and identifies possible future routes for improvement of the method. Currently, infrared thermography is not considered to be a fully reliable diagnostic method. If standard infrared protocol is established and a normative database is available, infrared thermography may become a reliable method for detecting inflammatory processes. PMID:29138741

Challenges to Global Implementation of Infrared Thermography Technology: Current Perspective.

PubMed

Shterenshis, Michael

2017-01-01

Medical infrared thermography (IT) produces an image of the infrared waves emitted by the human body as part of the thermoregulation process that can vary in intensity based on the health of the person. This review analyzes recent developments in the use of infrared thermography as a screening and diagnostic tool in clinical and nonclinical settings, and identifies possible future routes for improvement of the method. Currently, infrared thermography is not considered to be a fully reliable diagnostic method. If standard infrared protocol is established and a normative database is available, infrared thermography may become a reliable method for detecting inflammatory processes.

Clinical study of quantitative diagnosis of early cervical cancer based on the classification of acetowhitening kinetics

NASA Astrophysics Data System (ADS)

Wu, Tao; Cheung, Tak-Hong; Yim, So-Fan; Qu, Jianan Y.

2010-03-01

A quantitative colposcopic imaging system for the diagnosis of early cervical cancer is evaluated in a clinical study. This imaging technology based on 3-D active stereo vision and motion tracking extracts diagnostic information from the kinetics of acetowhitening process measured from the cervix of human subjects in vivo. Acetowhitening kinetics measured from 137 cervical sites of 57 subjects are analyzed and classified using multivariate statistical algorithms. Cross-validation methods are used to evaluate the performance of the diagnostic algorithms. The results show that an algorithm for screening precancer produced 95% sensitivity (SE) and 96% specificity (SP) for discriminating normal and human papillomavirus (HPV)-infected tissues from cervical intraepithelial neoplasia (CIN) lesions. For a diagnostic algorithm, 91% SE and 90% SP are achieved for discriminating normal tissue, HPV infected tissue, and low-grade CIN lesions from high-grade CIN lesions. The results demonstrate that the quantitative colposcopic imaging system could provide objective screening and diagnostic information for early detection of cervical cancer.

[New Radiopharmaceuticals Based on Prostate-Specific Inhibitors of Membrane Antigen for Diagnostics and Therapy of Metastatic Prostate Cancer].

PubMed

Vlasova, O P; German, K E; Krilov, V V; Petriev, V M; Epstein, N B

2015-01-01

About 10.7% cases of prostate cancer were registered in Russia in 2011 (40,000 patients). More than half of cancer cases were revealed in advanced (III-IV) stages when metastases inevitably developed quickly. Clinical problem of early diagnostics and treatment of metastatic prostate cancer is still not solved. Anatomical imaging techniques have low sensitivity and specificity for the detection of this disease. Metabolic visualization methods which use prostate specific antigen (PSA) as a marker are also ineffective. This article describes prostate-specific membrane antigens (PSMA) that are proposed as a marker for diagnostics and therapy of prostate cancer. The most promising PSMA-based radiopharmaceutical agent for diagnostics has been developed and clinically tested in the European countries. These pharmaceuticals are based on small peptide molecules modified with urea, and have the highest affinity to PSMA. Favorable phannacokinetics, rapid accumulation in the tumor and rapid excretion from the body are beneficial features of these pharmaceuticals.

Diagnostic reasoning strategies and diagnostic success.

PubMed

Coderre, S; Mandin, H; Harasym, P H; Fick, G H

2003-08-01

Cognitive psychology research supports the notion that experts use mental frameworks or "schemes", both to organize knowledge in memory and to solve clinical problems. The central purpose of this study was to determine the relationship between problem-solving strategies and the likelihood of diagnostic success. Think-aloud protocols were collected to determine the diagnostic reasoning used by experts and non-experts when attempting to diagnose clinical presentations in gastroenterology. Using logistic regression analysis, the study found that there is a relationship between diagnostic reasoning strategy and the likelihood of diagnostic success. Compared to hypothetico-deductive reasoning, the odds of diagnostic success were significantly greater when subjects used the diagnostic strategies of pattern recognition and scheme-inductive reasoning. Two other factors emerged as independent determinants of diagnostic success: expertise and clinical presentation. Not surprisingly, experts outperformed novices, while the content area of the clinical cases in each of the four clinical presentations demonstrated varying degrees of difficulty and thus diagnostic success. These findings have significant implications for medical educators. It supports the introduction of "schemes" as a means of enhancing memory organization and improving diagnostic success.

A Gram Stain Hands-On Workshop Enhances First Year Medical Students' Technique Competency in Comprehension and Memorization.

PubMed

Delfiner, Matthew S; Martinez, Luis R; Pavia, Charles S

2016-01-01

Laboratory diagnostic tests have an essential role in patient care, and the increasing number of medical and health professions schools focusing on teaching laboratory medicine to pre-clinical students reflects this importance. However, data validating the pedagogical methods that best influence students' comprehension and interpretation of diagnostic tests have not been well described. The Gram stain is a simple yet significant and frequently used diagnostic test in the clinical setting that helps classify bacteria into two major groups, Gram positive and negative, based on their cell wall structure. We used this technique to assess which educational strategies may improve students' learning and competency in medical diagnostic techniques. Hence, in this randomized controlled study, we compared the effectiveness of several educational strategies (e.g. workshop, discussion, or lecture) in first year medical students' competency in comprehension and interpretation of the Gram stain procedure. We demonstrated that a hands-on practical workshop significantly enhances students' competency in memorization and overall comprehension of the technique. Interestingly, most students irrespective of their cohort showed difficulty in answering Gram stain-related analytical questions, suggesting that more emphasis should be allocated by the instructors to clearly explain the interpretation of the diagnostic test results to students in medical and health professional schools. This proof of principle study highlights the need of practical experiences on laboratory medical techniques during pre-clinical training to facilitate future medical doctors' and healthcare professionals' basic understanding and competency in diagnostic testing for better patient care.

Identification of Clinical Markers of Specific Language Impairment in Adults

ERIC Educational Resources Information Center

Poll, Gerard H.; Betz, Stacy K.; Miller, Carol A.

2010-01-01

Purpose: To investigate the usefulness of 3 tasks known to be effective diagnostic clinical markers of specific language impairment (SLI) in children: (a) nonword repetition, (b) sentence repetition, and (c) grammaticality judgments of finiteness marking. Method: Two groups of young adults, 13 with SLI and 18 with typical language, completed 3…

Testing the Efficacy of an Education-Based Training Tool to Improve Diagnostic Accuracy of Obsessive-Compulsive Disorder

ERIC Educational Resources Information Center

Glazier, Kimberly

2014-01-01

Objective: The study aimed to increase awareness of OCD symptomatology among doctoral students in clinical, counseling and school psychology through the implementation of a comprehensive OCD education-based training tool. Method: The program directors across all APA-accredited clinical, counseling, and school psychology doctoral graduate programs…

Validation of the Quantitative Diagnostic Thinking Inventory for Athletic Training: A Pilot Study

ERIC Educational Resources Information Center

Kicklighter, Taz; Barnum, Mary; Geisler, Paul R.; Martin, Malissa

2016-01-01

Context: The cognitive process of making a clinical decision lies somewhere on a continuum between novices using hypothetico-deductive reasoning and experts relying more on case pattern recognition. Although several methods exist for measuring facets of clinical reasoning in specific situations, none have been experimentally applied, as of yet, to…

Diagnostic Efficacy of Cell Block Immunohistochemistry, Smear Cytology, and Liquid-Based Cytology in Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Lesions: A Single-Institution Experience

PubMed Central

Qin, Shan-yu; Zhou, You; Li, Ping; Jiang, Hai-xing

2014-01-01

Background The diagnostic efficiency of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) cytology varies widely depending on the treatment method of the specimens. The present study aimed to evaluate the diagnostic efficacy of cell block (CB) immunohistochemistry, smear cytology (SC), and liquid-based cytology (LBC) in patients with pancreatic lesions without consulting an on-site cytopathologist. Methods This study prospectively enrolled 72 patients with pancreatic lesions. The EUS-FNA specimens were examined by SC, LBC, and CB immunohistochemistry. The diagnostic efficacy of the 3 methods was then compared. Patients’ final diagnosis was confirmed by surgical resection specimens, diagnostic imaging, and clinical follow-up. Results Our results included 60 malignant and 12 benign pancreatic lesions. The diagnostic sensitivity (90%), negative predictive value (66.7%), and accuracy (91.7%) of CB immunohistochemistry were significantly higher than those of SC (70.0%, 30.0%, and 75.0%, respectively) and LBC (73.3%, 31.6%, and 77.8%, respectively) (all P<0.05). The combination of CB and SC, or CB and LBC, did not significantly increase the efficacy compared to CB immunohistochemistry alone. Conclusion Our findings suggest that in the absence of an on-site cytopathologist, CB immunohistochemistry on EUS-FNA specimens offers a higher diagnostic efficacy in patients with pancreatic lesions than does SC and LBC. PMID:25259861

The Added Value of the Combined Use of the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule: Diagnostic Validity in a Clinical Swedish Sample of Toddlers and Young Preschoolers

ERIC Educational Resources Information Center

Zander, Eric; Sturm, Harald; Bölte, Sven

2015-01-01

The diagnostic validity of the new research algorithms of the Autism Diagnostic Interview-Revised and the revised algorithms of the Autism Diagnostic Observation Schedule was examined in a clinical sample of children aged 18-47 months. Validity was determined for each instrument separately and their combination against a clinical consensus…

A Vision for Better Health: Mass Spectrometry Imaging for Clinical Diagnostics

PubMed Central

Ye, Hui; Gemperline, Erin; Li, Lingjun

2012-01-01

Background Mass spectrometry imaging (MSI) is a powerful tool that grants the ability to investigate a broad mass range of molecules from small molecules to large proteins by creating detailed distribution maps of selected compounds. Its usefulness in biomarker discovery towards clinical applications has obtained success by correlating the molecular expression of tissues acquired from MSI with well-established histology. Results To date, MSI has demonstrated its versatility in clinical applications, such as biomarker diagnostics of different diseases, prognostics of disease severities and metabolic response to drug treatment, etc. These studies have provided significant insight in clinical studies over the years and current technical advances are further facilitating the improvement of this field. Although the underlying concept is simple, factors such as choice of ionization method, sample preparation, instrumentation and data analysis must be taken into account for successful applications of MSI. Herein, we briefly reviewed these key elements yet focused on the clinical applications of MSI that cannot be addressed by other means. Conclusions Challenges and future perspectives in this field are also discussed to conclude that the ever-growing applications with continuous development of this powerful analytical tool will lead to a better understanding of the biology of diseases and improvements in clinical diagnostics. PMID:23078851

Clinical Diagnosis of the Dampness and Mold Hypersensitivity Syndrome: Review of the Literature and Suggested Diagnostic Criteria

PubMed Central

Valtonen, Ville

2017-01-01

A great variety of non-specific symptoms may occur in patients living or working in moisture-damaged buildings. In the beginning, these symptoms are usually reversible, mild, and present irritation of mucosa and increased morbidity due to respiratory tract infections and asthma-like symptoms. Later, the disease may become chronic and a patient is referred to a doctor where the assessment of dampness and mold hypersensitivity syndrome (DMHS) often presents diagnostic challenges. Currently, unanimously accepted laboratory tests are not yet available. Therefore, the diagnosis of DMHS is clinical and is based on the patient’s history and careful examination. In this publication, I reviewed contemporary knowledge on clinical presentations, laboratory methods, and clinical assessment of DMHS. From the literature, I have not found any proposed diagnostic clinical criteria. Therefore, I propose five clinical criteria to diagnose DMHS: (1) the history of mold exposure in water-damaged buildings, (2) increased morbidity to due infections, (3) sick building syndrome, (4) multiple chemical sensitivity, and (5) enhanced scent sensitivity. If all the five criteria are met, the patient has a very probable DMHS. To resolve the current problems in assigning correct DMHS diagnosis, we also need novel assays to estimate potential risks of developing DMHS. PMID:28848553

Clinical Diagnosis of the Dampness and Mold Hypersensitivity Syndrome: Review of the Literature and Suggested Diagnostic Criteria.

PubMed

Valtonen, Ville

2017-01-01

A great variety of non-specific symptoms may occur in patients living or working in moisture-damaged buildings. In the beginning, these symptoms are usually reversible, mild, and present irritation of mucosa and increased morbidity due to respiratory tract infections and asthma-like symptoms. Later, the disease may become chronic and a patient is referred to a doctor where the assessment of dampness and mold hypersensitivity syndrome (DMHS) often presents diagnostic challenges. Currently, unanimously accepted laboratory tests are not yet available. Therefore, the diagnosis of DMHS is clinical and is based on the patient's history and careful examination. In this publication, I reviewed contemporary knowledge on clinical presentations, laboratory methods, and clinical assessment of DMHS. From the literature, I have not found any proposed diagnostic clinical criteria. Therefore, I propose five clinical criteria to diagnose DMHS: (1) the history of mold exposure in water-damaged buildings, (2) increased morbidity to due infections, (3) sick building syndrome, (4) multiple chemical sensitivity, and (5) enhanced scent sensitivity. If all the five criteria are met, the patient has a very probable DMHS. To resolve the current problems in assigning correct DMHS diagnosis, we also need novel assays to estimate potential risks of developing DMHS.

Evaluation of Accuracy of DIAGNOdent in Diagnosis of Primary and Secondary Caries in Comparison to Conventional Methods

PubMed Central

Nokhbatolfoghahaie, Hanieh; Alikhasi, Marzieh; Chiniforush, Nasim; Khoei, Farzaneh; Safavi, Nassimeh; Yaghoub Zadeh, Behnoush

2013-01-01

Introduction: Today the prevalence of teeth decays has considerably decreased. Related organizations and institutions mention several reasons for it such as improvement of decay diagnostic equipment and tools which are even capable of detecting caries in their initial stages. This resulted in reduction of costs for patients and remarkable increase in teeth life span. There are many methods for decay diagnostic, like: visual and radiographic methods, devices with fluorescence such as Quantitative light-induced fluorescence (QLF), Vista proof, Laser fluorescence (LF or DIAGNOdent), Fluorescence Camera (FC) and Digital radiography. Although DIAGNOdent is considered a valuable device for decay diagnostic ,there are concerns regarding its efficacy and accuracy. Considering the sensitivity of decaydiagnosis and the exorbitant annual expenses supported by government and people for caries treatment, finding the best method for early caries detection is of the most importance. Numerous studies were performed to compare different diagnostic methods with conflicting results. The objective of this study is a comparative review of the efficiency of DIAGNOdent in comparison to visual methods and radiographic methods in the diagnostic of teeth occlusal surfaces. Methods: Search of PubMed, Google Scholar electronic resources was performed in order to find clinical trials in English in the period between 1998 and 2013. Full texts of only 35 articles were available. Conclusion: Considering the sensitivity and specificity reported in the different studies, it seems that DIAGNOdent is an appropriate modality for caries detection as a complementary method beside other methods and its use alone to obtain treatment plan is not enough. PMID:25606325

Diagnostic Tests to Support Late-Stage Control Programs for Schistosomiasis and Soil-Transmitted Helminthiases.

PubMed

Hawkins, Kenneth R; Cantera, Jason L; Storey, Helen L; Leader, Brandon T; de Los Santos, Tala

2016-12-01

Global efforts to address schistosomiasis and soil-transmitted helminthiases (STH) include deworming programs for school-aged children that are made possible by large-scale drug donations. Decisions on these mass drug administration (MDA) programs currently rely on microscopic examination of clinical specimens to determine the presence of parasite eggs. However, microscopy-based methods are not sensitive to the low-intensity infections that characterize populations that have undergone MDA. Thus, there has been increasing recognition within the schistosomiasis and STH communities of the need for improved diagnostic tools to support late-stage control program decisions, such as when to stop or reduce MDA. Failure to adequately address the need for new diagnostics could jeopardize achievement of the 2020 London Declaration goals. In this report, we assess diagnostic needs and landscape potential solutions and determine appropriate strategies to improve diagnostic testing to support control and elimination programs. Based upon literature reviews and previous input from experts in the schistosomiasis and STH communities, we prioritized two diagnostic use cases for further exploration: to inform MDA-stopping decisions and post-MDA surveillance. To this end, PATH has refined target product profiles (TPPs) for schistosomiasis and STH diagnostics that are applicable to these use cases. We evaluated the limitations of current diagnostic methods with regards to these use cases and identified candidate biomarkers and diagnostics with potential application as new tools. Based on this analysis, there is a need to develop antigen-detecting rapid diagnostic tests (RDTs) with simplified, field-deployable sample preparation for schistosomiasis. Additionally, there is a need for diagnostic tests that are more sensitive than the current methods for STH, which may include either a field-deployable molecular test or a simple, low-cost, rapid antigen-detecting test.

Upper Extremity Injuries in Tennis Players: Diagnosis, Treatment, and Management.

PubMed

Chung, Kevin C; Lark, Meghan E

2017-02-01

Upper extremity tennis injuries are most commonly characterized as overuse injuries to the wrist, elbow, and shoulder. The complex anatomy of these structures and their interaction with biomechanical properties of tennis strokes contributes to the diagnostic challenges. A thorough understanding of tennis kinetics, in combination with the current literature surrounding diagnostic and treatment methods, will improve clinical decision-making. Copyright © 2016 Elsevier Inc. All rights reserved.

[Characteristics of morphological manifestations of anaphylactic shock in response to the administration of pharmaceutical preparations encountered in the practice of forensic medical expert-histologist].

PubMed

Denisova, O P; Kul'bitskiĭ, B N; Putintsev, V A; Bogomolova, I N; Bogomolov, D V

2012-01-01

The authors report the results of a forensic medical investigation of 6 cases of death associated with the administration of pharmaceutical products documented by forensic medical experts of the Russian Centre of Forensic Medical Expertise. The results of the study are compared with the clinical data and summarized using the methods of tanatogenetic analysis. The following main clinical variants of iatrogenic anaphylactic shock (IAS) are distinguished: bronchospastic IAS (n = 1), asphyxic IAS (n = 1), hemodynamic IAS (n = 3), and combined (bronchospastic plus hemodynamic) IAS (n = 1). The signs of all these variants are described allowing for their diagnostics and differentiation diagnostics. These data can be used for the purpose of forensic medical diagnostics and elucidation of the mechanisms of tanatogenesis.

High-sensitivity MALDI-TOF MS quantification of anthrax lethal toxin for diagnostics and evaluation of medical countermeasures.

PubMed

Boyer, Anne E; Gallegos-Candela, Maribel; Quinn, Conrad P; Woolfitt, Adrian R; Brumlow, Judith O; Isbell, Katherine; Hoffmaster, Alex R; Lins, Renato C; Barr, John R

2015-04-01

Inhalation anthrax has a rapid progression and high fatality rate. Pathology and death from inhalation of Bacillus anthracis spores are attributed to the actions of secreted protein toxins. Protective antigen (PA) binds and imports the catalytic component lethal factor (LF), a zinc endoprotease, and edema factor (EF), an adenylyl cyclase, into susceptible cells. PA-LF is termed lethal toxin (LTx) and PA-EF, edema toxin. As the universal transporter for both toxins, PA is an important target for vaccination and immunotherapeutic intervention. However, its quantification has been limited to methods of relatively low analytic sensitivity. Quantification of LTx may be more clinically relevant than LF or PA alone because LTx is the toxic form that acts on cells. A method was developed for LTx-specific quantification in plasma using anti-PA IgG magnetic immunoprecipitation of PA and quantification of LF activity that co-purified with PA. The method was fast (<4 h total time to detection), sensitive at 0.033 ng/mL LTx in plasma for the fast analysis (0.0075 ng/mL LTx in plasma for an 18 h reaction), precise (6.3-9.9% coefficient of variation), and accurate (0.1-12.7%error; n ≥ 25). Diagnostic sensitivity was 100% (n = 27 animal/clinical cases). Diagnostic specificity was 100% (n = 141). LTx was detected post-antibiotic treatment in 6/6 treated rhesus macaques and 3/3 clinical cases of inhalation anthrax and as long as 8 days post-treatment. Over the course of infection in two rhesus macaques, LTx was first detected at 0.101 and 0.237 ng/mL at 36 h post-exposure and increased to 1147 and 12,107 ng/mL in late-stage anthrax. This demonstrated the importance of LTx as a diagnostic and therapeutic target. This method provides a sensitive, accurate tool for anthrax toxin detection and evaluation of PA-directed therapeutics.

Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs†

PubMed Central

Clarke, Diana E.; Wilcox, Holly C.; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H.; Newcomer, Alison; Mckitty, Mellisha V.; Regier, Darrel A.; Narrow, William E.

2014-01-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients’ experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. PMID:24615761

Ebola virus disease: Biological and diagnostic evolution from 2014 to 2017.

PubMed

Mérens, A; Bigaillon, C; Delaune, D

2018-03-01

The Ebola virus disease outbreak observed in West Africa from March 2014 to June 2016 has led to many fundamental and applied research works. Knowledge of this virus has substantially increased. Treatment of many patients in epidemic countries and a few imported cases in developed countries led to developing new diagnostic methods and to adapt laboratory organization and biosafety precautions to perform conventional biological analyses. Clinical and biological monitoring of patients infected with Ebola virus disease helped to determine severity criteria and bad prognosis markers. It also contributed to showing the possibility of viral sanctuaries in patients and the risk of transmission after recovery. After a summary of recent knowledge of environmental and clinical viral persistence, we aimed to present new diagnostic methods and other biological tests that led to highlighting the pathophysiological consequences of Ebola virus disease and its prognostic markers. We also aimed to describe our lab experience in the care of Ebola virus-infected patients, especially technical and logistical changes between 2014 and 2017. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Development of an integrated Sasang constitution diagnosis method using face, body shape, voice, and questionnaire information

PubMed Central

2012-01-01

Background Sasang constitutional medicine (SCM) is a unique form of traditional Korean medicine that divides human beings into four constitutional types (Tae-Yang: TY, Tae-Eum: TE, So-Yang: SY, and So-Eum: SE), which differ in inherited characteristics, such as external appearance, personality traits, susceptibility to particular diseases, drug responses, and equilibrium among internal organ functions. According to SCM, herbs that belong to a certain constitution cannot be used in patients with other constitutions; otherwise, this practice may result in no effect or in an adverse effect. Thus, the diagnosis of SC type is the most crucial step in SCM practice. The diagnosis, however, tends to be subjective due to a lack of quantitative standards for SC diagnosis. Methods We have attempted to make the diagnosis method as objective as possible by basing it on an analysis of quantitative data from various Oriental medical clinics. Four individual diagnostic models were developed with multinomial logistic regression based on face, body shape, voice, and questionnaire responses. Inspired by SCM practitioners’ holistic diagnostic processes, an integrated diagnostic model was then proposed by combining the four individual models. Results The diagnostic accuracies in the test set, after the four individual models had been integrated into a single model, improved to 64.0% and 55.2% in the male and female patient groups, respectively. Using a cut-off value for the integrated SC score, such as 1.6, the accuracies increased by 14.7% in male patients and by 4.6% in female patients, which showed that a higher integrated SC score corresponded to a higher diagnostic accuracy. Conclusions This study represents the first trial of integrating the objectification of SC diagnosis based on quantitative data and SCM practitioners’ holistic diagnostic processes. Although the diagnostic accuracy was not great, it is noted that the proposed diagnostic model represents common rules among practitioners who have various points of view. Our results are expected to contribute as a desirable research guide for objective diagnosis in traditional medicine, as well as to contribute to the precise diagnosis of SC types in an objective manner in clinical practice. PMID:22762505

Clinical profiles and outcomes in idiopathic duct-centric chronic pancreatitis (type 2 autoimmune pancreatitis): the Mayo Clinic experience.

PubMed

Hart, Phil A; Levy, Michael J; Smyrk, Thomas C; Takahashi, Naoki; Abu Dayyeh, Barham K; Clain, Jonathan E; Gleeson, Ferga C; Pearson, Randall K; Petersen, Bret T; Topazian, Mark D; Vege, Santhi S; Zhang, Lizhi; Chari, Suresh T

2016-10-01

Idiopathic duct-centric chronic pancreatitis (IDCP), also known as type 2 autoimmune pancreatitis (AIP), is an uncommon subtype of AIP. International Consensus Diagnostic Criteria for IDCP propose that the diagnosis requires pancreatic histology and/or concurrent IBD. We examined our experience with IDCP (type 2 AIP) to assess the appropriateness of these criteria, and identify unique characteristics in patients presenting with acute pancreatitis. We reviewed the Mayo Clinic AIP database through May 2014 to identify subjects with either definitive (n=31) or probable (n=12) IDCP. We compared demographic and clinical factors based on strength of diagnostic confidence (definitive versus probable), presence of IBD, and acute pancreatitis as the presenting manifestation. Relapse-free survival was determined using the Kaplan-Meier method. The clinical profiles were similar irrespective of the diagnostic criteria fulfilled. Common clinical presentations included acute pancreatitis (n=25, 58.1%, 12 of whom (27.9%) had recurrent pancreatitis) and pancreatic mass/obstructive jaundice (n=15, 34.9%). The cumulative relapse rate was 10.6% at 3 years (median follow-up 2.9 years). Relapse-free survival was similar for the different diagnostic categories, but was decreased in those initially presenting with acute pancreatitis (p=0.047) or treated with steroids (vs surgery, p=0.049). The current diagnostic classification of probable IDCP and the inclusion of IBD as a supportive criterion appear valid, because patients have similar clinical profiles and disease-related outcomes to those with definitive IDCP. Concurrent IBD, especially in young patients, may suggest when IDCP is the underlying cause of recurrent acute pancreatitis, but additional studies are needed for validation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Quantum Cascade Laser-Based Infrared Microscopy for Label-Free and Automated Cancer Classification in Tissue Sections.

PubMed

Kuepper, Claus; Kallenbach-Thieltges, Angela; Juette, Hendrik; Tannapfel, Andrea; Großerueschkamp, Frederik; Gerwert, Klaus

2018-05-16

A feasibility study using a quantum cascade laser-based infrared microscope for the rapid and label-free classification of colorectal cancer tissues is presented. Infrared imaging is a reliable, robust, automated, and operator-independent tissue classification method that has been used for differential classification of tissue thin sections identifying tumorous regions. However, long acquisition time by the so far used FT-IR-based microscopes hampered the clinical translation of this technique. Here, the used quantum cascade laser-based microscope provides now infrared images for precise tissue classification within few minutes. We analyzed 110 patients with UICC-Stage II and III colorectal cancer, showing 96% sensitivity and 100% specificity of this label-free method as compared to histopathology, the gold standard in routine clinical diagnostics. The main hurdle for the clinical translation of IR-Imaging is overcome now by the short acquisition time for high quality diagnostic images, which is in the same time range as frozen sections by pathologists.

Use of dyes in cariology.

PubMed

van de Rijke, J W

1991-04-01

The property of dyes to enhance contrast by their colour can be used in clinical dentistry and in investigations in vitro or in vivo. They have been used for indication of affected dental tissues, improvement of diagnostic methods, enhancement of patient awareness and information about specific processes. The development of particular dye systems, aimed at clinical application, is often laborious because of toxic effects, lack of specificity, irreversible staining or difficulties with removal of the dye. Clinically used dyes are often visually observed, which means a qualitative assessment of the staining, while quantification of the staining, if performed at all, is confined mostly to laboratory experiments. In this paper the application of dyes, arranged according to their specific purpose in cariology, is discussed, and a brief historical overview is given of the development of two particular dye applications for which commercial dye systems are now available. If certain requirements are met, dyes can be of great help in detection and quantification when used with several diagnostic methods.

Functional diagnostics for thyrotropin hormone receptor autoantibodies: bioassays prevail over binding assays.

PubMed

Lytton, Simon David; Schluter, Anke; Banga, Paul J

2018-06-01

Autoantibodies to the thyrotropin hormone receptor (TSH-R) are directly responsible for the hyperthyroidism in Graves' disease and mediate orbital manifestations in Graves' orbitopathy (otherwise known as thyroid eye disease). These autoantibodies are heterogeneous in their function and collectively referred to as TRAbs. Measurement of TRAbs is clinically important for diagnosis of a variety of conditions and different commercial assays with high sensitivity and specificity are available for diagnostic purposes. This review provides overwhelming evidence that the TRAbs detected in binding assays by mainly the automated electrochemical luminescence immunoassays (ECLIA) do not distinguish TRAbs that stimulate the TSH-R (called TSIs or TSAbs) and TRAbs that just inhibit the binding of TSH without stimulating the TSH-R (called TBAbs). However, TSAbs and TBAbs have divergent pathogenic roles, and depending which fraction predominates cause different clinical symptoms and engender different therapeutic regimen. Therefore, diagnostic distinction of TSAbs and TBAbs is of paramount clinical importance. To date, only bioassays such as the Mc4 TSH-R bioassay (Thyretain TM , Quidel) and the Bridge assay (Immulite 2000, Siemens) can measure TSAbs, with only the former being able to distinguish between TSAbs and TBAbs. On this note, it is strongly recommended to only use the term TSI or TSAb when reporting the results of bioassays, whereas the results of automated TRAb binding assays should be reported as TRAbs (of undetermined functional significance). This review aims to present a technical and analytical account of leading commercial diagnostic methods of anti-TSH-R antibodies, a metaanalysis of their clinical performance and a perspective for the use of cell based TSH-R bioassays in the clinical diagnostics of Graves' disease.

Clinical Predictors of Shigella and Campylobacter Infection in Children in the United States

PubMed Central

Smith, Timothy; Ye, Xiangyang; Stockmann, Chris; Cohen, Daniel; Leber, Amy; Daly, Judy; Jackson, Jami; Selvarangan, Rangaraj; Kanwar, Neena; Bender, Jeffery; Bard, Jennifer Dien; Festekjian, Ara; Duffy, Susan; Larsen, Chari; Baca, Tanya; Holmberg, Kristen; Bourzac, Kevin; Chapin, Kimberle C; Pavia, Andrew; Leung, Daniel

2017-01-01

Abstract Background Infectious gastroenteritis is a major cause of morbidity and mortality among children worldwide. While most episodes are self-limiting, for select pathogens such as Shigella and Campylobacter, etiological diagnosis may allow effective antimicrobial therapy and aid public health interventions. Unfortunately, clinical predictors of such pathogens are not well established and are based on small studies using bacterial culture for identification. Methods We used prospectively collected data from a multi-center study of pediatric gastroenteritis employing multi-pathogen molecular diagnostics to determine clinical predictors associated with 1) Shigella and 2) Shigella or Campylobacter infection. We used machine learning algorithms for clinical predictor identification, then performed logistic regression on features extracted plus pre-selected variables of interest. Results Of 993 children enrolled with acute diarrhea, we detected Shigella spp. in 56 (5.6%) and Campylobacter spp. in 24 (2.4%). Compared with children who had neither pathogen detected (of whom, >70% had ≥1 potential pathogen identified), bloody diarrhea (odds ratio 4.0), headache (OR 2.2), fever (OR 7.1), summer (OR 3.3), and sick contact with GI illness (OR 2.2), were positively associated with Shigella, and out-of-state travel (OR 0.3) and vomiting and/or nausea (OR 0.4) were negatively associated (Table). For Shigella or Campylobacter, predictors were similar but season was no longer significantly associated with infection. Conclusion These results can create prediction models and assist clinicians with identifying patients who would benefit from diagnostic testing and earlier antibiotic treatment. This may curtail unnecessary antibiotic use, and help to direct and target appropriate use of stool diagnostics. Disclosures A. Leber, BioFIre Diagnostics: Research Contractor and Scientific Advisor, Research support, Speaker honorarium and Travel expenses J. Daly, Biofire: Grant Investigator, Grant recipient R. Selvarangan, BioFire Diagnostics: Board Member and Investigator, Consulting fee and Research grant Luminex Diagnostics: Investigator, Research grant J. Dien Bard, BioFire: Consultant and Investigator, Research grant and Speaker honorarium K. Holmberg, BioFire Diagnostics: Employee, Salary K. Bourzac, BioFire Diagnostics: Employee, Salary K. C. Chapin, BioFire Diagnstics: Investigator, Research support A. Pavia, BioFire Diagnostics: Grant Investigator, Research grant

Molecular diagnostics of neurodegenerative disorders.

PubMed

Agrawal, Megha; Biswas, Abhijit

2015-01-01

Molecular diagnostics provide a powerful method to detect and diagnose various neurological diseases such as Alzheimer's and Parkinson's disease. The confirmation of such diagnosis allows early detection and subsequent medical counseling that help specific patients to undergo clinically important drug trials. This provides a medical pathway to have better insight of neurogenesis and eventual cure of the neurodegenerative diseases. In this short review, we present recent advances in molecular diagnostics especially biomarkers and imaging spectroscopy for neurological diseases. We describe advances made in Alzheimer's disease (AD), Parkinson's disease (PD), Amyotrophic lateral sclerosis (ALS) and Huntington's disease (HD), and finally present a perspective on the future directions to provide a framework for further developments and refinements of molecular diagnostics to combat neurodegenerative disorders.

Computer-aided dermoscopy for diagnosis of melanoma

PubMed Central

Barzegari, Masoomeh; Ghaninezhad, Haiedeh; Mansoori, Parisa; Taheri, Arash; Naraghi, Zahra S; Asgari, Masood

2005-01-01

Background Computer-aided dermoscopy using artificial neural networks has been reported to be an accurate tool for the evaluation of pigmented skin lesions. We set out to determine the sensitivity and specificity of a computer-aided dermoscopy system for diagnosis of melanoma in Iranian patients. Methods We studied 122 pigmented skin lesions which were referred for diagnostic evaluation or cosmetic reasons. Each lesion was examined by two clinicians with naked eyes and all of their clinical diagnostic considerations were recorded. The lesions were analyzed using a microDERM® dermoscopy unit. The output value of the software for each lesion was a score between 0 and 10. All of the lesions were excised and examined histologically. Results Histopathological examination revealed melanoma in six lesions. Considering only the most likely clinical diagnosis, sensitivity and specificity of clinical examination for diagnosis of melanoma were 83% and 96%, respectively. Considering all clinical diagnostic considerations, the sensitivity and specificity were 100% and 89%. Choosing a cut-off point of 7.88 for dermoscopy score, the sensitivity and specificity of the score for diagnosis of melanoma were 83% and 96%, respectively. Setting the cut-off point at 7.34, the sensitivity and specificity were 100% and 90%. Conclusion The diagnostic accuracy of the dermoscopy system was at the level of clinical examination by dermatologists with naked eyes. This system may represent a useful tool for screening of melanoma, particularly at centers not experienced in the field of pigmented skin lesions. PMID:16000171

Exploration of Analysis Methods for Diagnostic Imaging Tests: Problems with ROC AUC and Confidence Scores in CT Colonography

PubMed Central

Mallett, Susan; Halligan, Steve; Collins, Gary S.; Altman, Doug G.

2014-01-01

Background Different methods of evaluating diagnostic performance when comparing diagnostic tests may lead to different results. We compared two such approaches, sensitivity and specificity with area under the Receiver Operating Characteristic Curve (ROC AUC) for the evaluation of CT colonography for the detection of polyps, either with or without computer assisted detection. Methods In a multireader multicase study of 10 readers and 107 cases we compared sensitivity and specificity, using radiological reporting of the presence or absence of polyps, to ROC AUC calculated from confidence scores concerning the presence of polyps. Both methods were assessed against a reference standard. Here we focus on five readers, selected to illustrate issues in design and analysis. We compared diagnostic measures within readers, showing that differences in results are due to statistical methods. Results Reader performance varied widely depending on whether sensitivity and specificity or ROC AUC was used. There were problems using confidence scores; in assigning scores to all cases; in use of zero scores when no polyps were identified; the bimodal non-normal distribution of scores; fitting ROC curves due to extrapolation beyond the study data; and the undue influence of a few false positive results. Variation due to use of different ROC methods exceeded differences between test results for ROC AUC. Conclusions The confidence scores recorded in our study violated many assumptions of ROC AUC methods, rendering these methods inappropriate. The problems we identified will apply to other detection studies using confidence scores. We found sensitivity and specificity were a more reliable and clinically appropriate method to compare diagnostic tests. PMID:25353643

Guided eruption of palatally impacted canines through combined use of 3-dimensional computerized tomography scans and the easy cuspid device.

PubMed

Caprioglio, Alberto; Siani, Lea; Caprioglio, Claudia

2007-01-01

The permanent maxillary canine has a high incidence of impaction. In the clinical treatment of impaction, the first problem is diagnosis and localization. The new diagnostic 3-dimensional systems shown in this article provide valid support in understanding anatomic connections and planning the movements needed for orthodontic correction. Thus, the clinician can reduce the incidence of iatrogenic damage of adjacent structures. This article reviews several biomedical systems for guided eruption of palatally impacted canines and discusses a new device for guided eruption of the surgically disimpacted tooth. This device, called Easy Cuspid, is designed to reduce recognized problems with reaction forces through a simple method. A clinical case of bilateral impaction of the permanent maxillary canines shows the application of the diagnostic method and the biomechanical system, Easy Cuspid.

Computer-aided diagnosis of retinopathy in retinal fundus images of preterm infants via quantification of vascular tortuosity

PubMed Central

Oloumi, Faraz; Rangayyan, Rangaraj M.; Ells, Anna L.

2016-01-01

Abstract. Retinopathy of prematurity (ROP), a disorder of the retina occurring in preterm infants, is the leading cause of preventable childhood blindness. An active phase of ROP that requires treatment is associated with the presence of plus disease, which is diagnosed clinically in a qualitative manner by visual assessment of the existence of a certain level of increase in the thickness and tortuosity of retinal vessels. The present study performs computer-aided diagnosis (CAD) of plus disease via quantitative measurement of tortuosity in retinal fundus images of preterm infants. Digital image processing techniques were developed for the detection of retinal vessels and measurement of their tortuosity. The total lengths of abnormally tortuous vessels in each quadrant and the entire image were then computed. A minimum-length diagnostic-decision-making criterion was developed to assess the diagnostic sensitivity and specificity of the values obtained. The area (Az) under the receiver operating characteristic curve was used to assess the overall diagnostic accuracy of the methods. Using a set of 19 retinal fundus images of preterm infants with plus disease and 91 without plus disease, the proposed methods provided an overall diagnostic accuracy of Az=0.98. Using the total length of all abnormally tortuous vessel segments in an image, our techniques are capable of CAD of plus disease with high accuracy without the need for manual selection of vessels to analyze. The proposed methods may be used in a clinical or teleophthalmological setting. PMID:28018938

A new generation of cancer genome diagnostics for routine clinical use: overcoming the roadblocks to personalized cancer medicine.

PubMed

Heuckmann, J M; Thomas, R K

2015-09-01

The identification of 'druggable' kinase gene alterations has revolutionized cancer treatment in the last decade by providing new and successfully targetable drug targets. Thus, genotyping tumors for matching the right patients with the right drugs have become a clinical routine. Today, advances in sequencing technology and computational genome analyses enable the discovery of a constantly growing number of genome alterations relevant for clinical decision making. As a consequence, several technological approaches have emerged in order to deal with these rapidly increasing demands for clinical cancer genome analyses. Here, we describe challenges on the path to the broad introduction of diagnostic cancer genome analyses and the technologies that can be applied to overcome them. We define three generations of molecular diagnostics that are in clinical use. The latest generation of these approaches involves deep and thus, highly sensitive sequencing of all therapeutically relevant types of genome alterations-mutations, copy number alterations and rearrangements/fusions-in a single assay. Such approaches therefore have substantial advantages (less time and less tissue required) over PCR-based methods that typically have to be combined with fluorescence in situ hybridization for detection of gene amplifications and fusions. Since these new technologies work reliably on routine diagnostic formalin-fixed, paraffin-embedded specimens, they can help expedite the broad introduction of personalized cancer therapy into the clinic by providing comprehensive, sensitive and accurate cancer genome diagnoses in 'real-time'. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Acid-fast Smear and Histopathology Results Provide Guidance for the Appropriate Use of Broad-Range Polymerase Chain Reaction and Sequencing for Mycobacteria.

PubMed

Miller, Kennon; Harrington, Susan M; Procop, Gary W

2015-08-01

New molecular diagnostic tests are attractive because of the potential they hold for improving diagnostics in microbiology. The value of these tests, which is often assumed, should be investigated to determine the best use of these potentially powerful tools. To investigate the usefulness of broad-range polymerase chain reaction (PCR), followed by sequencing, in mycobacterial infections. We reviewed the test performance of acid-fast bacilli (AFB) PCR and traditional diagnostic methods (histopathology, AFB smear, and culture). We assessed the diagnostic effect and cost of the unrestricted ordering of broad-range PCR for the detection and identification of mycobacteria in clinical specimens. The AFB PCR was less sensitive than culture and histopathology and was less specific than culture, AFB smear, and histopathology. During 18 months, $93 063 was spent on 183 patient specimens for broad-range PCR and DNA sequencing for mycobacteria to confirm one culture-proven Mycobacterium tuberculosis infection that was also known to be positive by AFB smear and histopathology. In this cohort, there was a false-negative AFB PCR for M tuberculosis and a false-positive AFB PCR for Mycobacterium lentiflavum . Testing of AFB smear-negative specimens from patients without an inflammatory response supportive of a mycobacterial infection is costly and has not been proven to improve patient care. Traditional diagnostics (histopathology, AFB smear, and culture) should remain the primary methods for the detection of mycobacteria in clinical specimens.

Development of a novel diagnostic algorithm to predict NASH in HCV-positive patients.

PubMed

Gallotta, Andrea; Paneghetti, Laura; Mrázová, Viera; Bednárová, Adriana; Kružlicová, Dáša; Frecer, Vladimir; Miertus, Stanislav; Biasiolo, Alessandra; Martini, Andrea; Pontisso, Patrizia; Fassina, Giorgio

2018-05-01

Non-alcoholic steato-hepatitis (NASH) is a severe disease characterised by liver inflammation and progressive hepatic fibrosis, which may progress to cirrhosis and hepatocellular carcinoma. Clinical evidence suggests that in hepatitis C virus patients steatosis and NASH are associated with faster fibrosis progression and hepatocellular carcinoma. A safe and reliable non-invasive diagnostic method to detect NASH at its early stages is still needed to prevent progression of the disease. We prospectively enrolled 91 hepatitis C virus-positive patients with histologically proven chronic liver disease: 77 patients were included in our study; of these, 10 had NASH. For each patient, various clinical and serological variables were collected. Different algorithms combining squamous cell carcinoma antigen-immunoglobulin-M (SCCA-IgM) levels with other common clinical data were created to provide the probability of having NASH. Our analysis revealed a statistically significant correlation between the histological presence of NASH and SCCA-IgM, insulin, homeostasis model assessment, haemoglobin, high-density lipoprotein and ferritin levels, and smoke. Compared to the use of a single marker, algorithms that combined four, six or seven variables identified NASH with higher accuracy. The best diagnostic performance was obtained with the logistic regression combination, which included all seven variables correlated with NASH. The combination of SCCA-IgM with common clinical data shows promising diagnostic performance for the detection of NASH in hepatitis C virus patients.

Patient-Centered Research

PubMed Central

Wicki, J; Perneger, TV; Junod, AF; Bounameaux, H; Perrier, A

2000-01-01

PURPOSE We aimed to develop a simple standardized clinical score to stratify emergency ward patients with clinically suspected PE into groups with a high, intermediate, or low probability of PE, in order to improve and simplify the diagnostic approach. METHODS Analysis of a database of 1090 consecutive patients admitted to the emergency ward for suspected PE, in whom diagnosis of PE was ruled in or out by a standard diagnostic algorithm. Logistic regression was used to predict clinical parameters associated with PE. RESULTS 296 out of 1090 patients (27%) were found to have PE. The optimal estimate of clinical probability was based on eight variables: recent surgery, previous thromboembolic event, older age, hypocapnia, hypoxemia, tachycardia, band atelectasis or elevation of a hemidiaphragm on chest X-ray. A probability score was calculated by adding points assigned to these variables. A cut-off score of 4 best identified patients with low probability of PE. 486 patients (49%) had a low clinical probability of PE (score < 4), of which 50 (10.3%) had a proven PE. The prevalence of PE was 38% in the 437 patients with an intermediate probability (score 5–8, n = 437) and 81% in the 63 patients with a high probability (score>9). CONCLUSION This clinical score, based on easily available and objective variables, provides a standardized assessment of the clinical probability of PE. Applying this score to emergency ward patients suspected of PE could allow a more efficient diagnostic process.

Diagnostic tests in HIV management: a review of clinical and laboratory strategies to monitor HIV-infected individuals in developing countries.

PubMed Central

Kimmel, April D.; Losina, Elena; Freedberg, Kenneth A.; Goldie, Sue J.

2006-01-01

We conducted a systematic review on the performance of diagnostic tests for clinical and laboratory monitoring of HIV-infected adults in developing countries. Diagnostic test information collected from computerized databases, bibliographies and the Internet were categorized as clinical (non-laboratory patient information), immunologic (information from immunologic laboratory tests), or virologic (information from virologic laboratory tests). Of the 51 studies selected for the review 28 assessed immunologic tests, 12 virologic tests and seven clinical and immunologic tests. Methods of performance evaluation were primarily sensitivity and specificity for the clinical category and correlation coefficients for immunologic and virologic categories. In the clinical category, the majority of test performance measures was reported as >70% sensitive and >65% specific. In the immunologic category, correlation coefficients ranged from r=0.54 to r=0.99 for different CD4 count enumeration techniques, while correlation for CD4 and total lymphocyte counts was between r=0.23 and r=0.74. In the virologic category, correlation coefficients for different human immunodeficiency virus (HIV) ribonucleic acid (RNA) quantification techniques ranged from r=0.54 to r=0.90. Future research requires consensus on designing studies, and collecting and reporting data useful for decision-makers. We recommend classifying information into clinically relevant categories, using a consistent definition of disease across studies and providing measures of both association and accuracy. PMID:16878233

Quality in the molecular microbiology laboratory.

PubMed

Wallace, Paul S; MacKay, William G

2013-01-01

In the clinical microbiology laboratory advances in nucleic acid detection, quantification, and sequence analysis have led to considerable improvements in the diagnosis, management, and monitoring of infectious diseases. Molecular diagnostic methods are routinely used to make clinical decisions based on when and how to treat a patient as well as monitor the effectiveness of a therapeutic regime and identify any potential drug resistant strains that may impact on the long term patient treatment program. Therefore, confidence in the reliability of the result provided by the laboratory service to the clinician is essential for patient treatment. Hence, suitable quality assurance and quality control measures are important to ensure that the laboratory methods and service meet the necessary regulatory requirements both at the national and international level. In essence, the modern clinical microbiology laboratory ensures the appropriateness of its services through a quality management system that monitors all aspects of the laboratory service pre- and post-analytical-from patient sample receipt to reporting of results, from checking and upholding staff competency within the laboratory to identifying areas for quality improvements within the service offered. For most European based clinical microbiology laboratories this means following the common International Standard Organization (ISO9001) framework and ISO15189 which sets out the quality management requirements for the medical laboratory (BS EN ISO 15189 (2003) Medical laboratories-particular requirements for quality and competence. British Standards Institute, Bristol, UK). In the United States clinical laboratories performing human diagnostic tests are regulated by the Centers for Medicare and Medicaid Services (CMS) following the requirements within the Clinical Laboratory Improvement Amendments document 1988 (CLIA-88). This chapter focuses on the key quality assurance and quality control requirements within the modern microbiology laboratory providing molecular diagnostics.

Clinically inappropriate post hoc exclusion of study participants from test accuracy calculations: the ROMA score, an example from a recent NICE diagnostic assessment.

PubMed

Lang, Shona; Armstrong, Nigel; Deshpande, Sohan; Ramaekers, Bram; Grimm, Sabine; de Kock, Shelley; Kleijnen, Jos; Westwood, Marie

2018-01-01

Objective To explore how the definition of the target condition and post hoc exclusion of participants can limit the usefulness of diagnostic accuracy studies. Methods We used data from a systematic review, conducted for a NICE diagnostic assessment of risk scores to inform secondary care decisions about specialist referral for women with suspected ovarian cancer, to explore how the definition of the target condition and post hoc exclusion of participants can limit the usefulness of diagnostic accuracy studies to inform clinical practice. Results Fourteen of the studies evaluated the ROMA score, nine used Abbott ARCHITECT tumour marker assays, five used Roche Elecsys. The summary sensitivity estimate (Abbott ARCHITECT) was highest, 95.1% (95% CI: 92.4 to 97.1%), where analyses excluded participants with borderline tumours or malignancies other than epithelial ovarian cancer and lowest, 75.0% (95% CI: 60.4 to 86.4%), where all participants were included. Results were similar for Roche Elecsys tumour marker assays. Although the number of patients involved was small, data from studies that reported diagnostic accuracy for both the whole study population and with post hoc exclusion of those with borderline or non-epithelial malignancies suggested that patients with borderline or malignancies other than epithelial ovarian cancer accounts for between 50 and 85% of false-negative ROMA scores. Conclusions Our results illustrate the potential consequences of inappropriate population selection in diagnostic studies; women with non-epithelial ovarian cancers or non-ovarian primaries, and those borderline tumours may be disproportionately represented among those with false negative, 'low risk' ROMA scores. These observations highlight the importance of giving careful consideration to how the target condition has been defined when assessing whether the diagnostic accuracy estimates reported in clinical studies will translate into clinical utility in real-world settings.

Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group.

PubMed

Garfield, Susan; Polisena, Julie; S Spinner, Daryl; Postulka, Anne; Y Lu, Christine; Tiwana, Simrandeep K; Faulkner, Eric; Poulios, Nick; Zah, Vladimir; Longacre, Michael

2016-01-01

Health technology assessments (HTAs) are increasingly used to inform coverage, access, and utilization of medical technologies including molecular diagnostics (MDx). Although MDx are used to screen patients and inform disease management and treatment decisions, there is no uniform approach to their evaluation by HTA organizations. The International Society for Pharmacoeconomics and Outcomes Research Devices and Diagnostics Special Interest Group reviewed diagnostic-specific HTA programs and identified elements representing common and best practices. MDx-specific HTA programs in Europe, Australia, and North America were characterized by methodology, evaluation framework, and impact. Published MDx HTAs were reviewed, and five representative case studies of test evaluations were developed: United Kingdom (National Institute for Health and Care Excellence's Diagnostics Assessment Programme, epidermal growth factor receptor tyrosine kinase mutation), United States (Palmetto's Molecular Diagnostic Services Program, OncotypeDx prostate cancer test), Germany (Institute for Quality and Efficiency in Healthcare, human papillomavirus testing), Australia (Medical Services Advisory Committee, anaplastic lymphoma kinase testing for non-small cell lung cancer), and Canada (Canadian Agency for Drugs and Technologies in Health, Rapid Response: Non-invasive Prenatal Testing). Overall, the few HTA programs that have MDx-specific methods do not provide clear parameters of acceptability related to clinical and analytic performance, clinical utility, and economic impact. The case studies highlight similarities and differences in evaluation approaches across HTAs in the performance metrics used (analytic and clinical validity, clinical utility), evidence requirements, and how value is measured. Not all HTAs are directly linked to reimbursement outcomes. To improve MDx HTAs, organizations should provide greater transparency, better communication and collaboration between industry and HTA stakeholders, clearer links between HTA and funding decisions, explicit recognition of and rationale for differential approaches to laboratory-developed versus regulatory-approved test, and clear evidence requirements. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Recent advances in low-cost microfluidic platforms for diagnostic applications.

PubMed

Tomazelli Coltro, Wendell Karlos; Cheng, Chao-Min; Carrilho, Emanuel; de Jesus, Dosil Pereira

2014-08-01

The use of inexpensive materials and cost-effective manufacturing processes for mass production of microfluidic devices is very attractive and has spurred a variety of approaches. Such devices are particularly suited for diagnostic applications in limited resource settings. This review describes the recent and remarkable advances in the use of low-cost substrates for the development of microfluidic devices for diagnostics and clinical assays. Thus, a plethora of new and improved fabrication methods, designs, capabilities, detections, and applications of microfluidic devices fabricated with paper, plastic, and threads are covered. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Expanding the Taxonomy of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)

PubMed Central

Peck, Christopher C.; Goulet, Jean-Paul; Lobbezoo, Frank; Schiffman, Eric L.; Alstergren, Per; Anderson, Gary C.; de Leeuw, Reny; Jensen, Rigmor; Michelotti, Ambra; Ohrbach, Richard; Petersson, Arne; List, Thomas

2014-01-01

Background There is a need to expand the current temporomandibular disorder (TMD) classification to include less common, but clinically important disorders. The immediate aim was to develop a consensus-based classification system and associated diagnostic criteria that have clinical and research utility for less common TMDs. The long-term aim was to establish a foundation, vis-à-vis this classification system, that will stimulate data collection, validity testing, and further criteria refinement. Methods A working group [members of the International RDC/TMD Consortium Network of the International Association for Dental Research (IADR), members of the Orofacial Pain Special Interest Group (SIG) of the International Association for the Study of Pain (IASP), and members from other professional societies] reviewed disorders for inclusion based on clinical significance, the availability of plausible diagnostic criteria, and the ability to operationalize and study the criteria. The disorders were derived from the literature when possible and based on expert opinion as necessary. The expanded TMD taxonomy was presented for feedback at international meetings. Results Of 56 disorders considered, 37 were included in the expanded taxonomy and were placed into the following four categories: temporomandibular joint disorders, masticatory muscle disorders, headache disorders, and disorders affecting associated structures. Those excluded were extremely uncommon, lacking operationalized diagnostic criteria, not clearly related to TMDs, or not sufficiently distinct from disorders already included within the taxonomy. Conclusions The expanded TMD taxonomy offers an integrated approach to clinical diagnosis and provides a framework for further research to operationalize and test the proposed taxonomy and diagnostic criteria. PMID:24443898

Diagnosis of Food Allergy.

PubMed

Gupta, Malika; Cox, Amanda; Nowak-Węgrzyn, Anna; Wang, Julie

2018-02-01

Food allergy diagnosis remains challenging. Most standard methods are unable to differentiate sensitization from clinical allergy. Recognizing food allergy is of utmost importance to prevent life-threatening reactions. On the other hand, faulty interpretation of tests leads to overdiagnosis and unnecessary food avoidances. Highly predictive models have been established for major food allergens based on skin prick testing and food-specific immunoglobulin E but are lacking for most other foods. Although many newer diagnostic techniques are improving the accuracy of food allergy diagnostics, an oral food challenge remains the only definitive method of confirming a food allergy. Copyright © 2017 Elsevier Inc. All rights reserved.

Diagnostic analysis of liver B ultrasonic texture features based on LM neural network

NASA Astrophysics Data System (ADS)

Chi, Qingyun; Hua, Hu; Liu, Menglin; Jiang, Xiuying

2017-03-01

In this study, B ultrasound images of 124 benign and malignant patients were randomly selected as the study objects. The B ultrasound images of the liver were treated by enhanced de-noising. By constructing the gray level co-occurrence matrix which reflects the information of each angle, Principal Component Analysis of 22 texture features were extracted and combined with LM neural network for diagnosis and classification. Experimental results show that this method is a rapid and effective diagnostic method for liver imaging, which provides a quantitative basis for clinical diagnosis of liver diseases.

Laboratory Diagnosis of Congenital Toxoplasmosis

PubMed Central

Pomares, Christelle

2016-01-01

Recent studies have demonstrated that screening and treatment for toxoplasmosis during gestation result in a decrease of vertical transmission and clinical sequelae. Early treatment was associated with improved outcomes. Thus, laboratory methods should aim for early identification of infants with congenital toxoplasmosis (CT). Diagnostic approaches should include, at least, detection of Toxoplasma IgG, IgM, and IgA and a comprehensive review of maternal history, including the gestational age at which the mother was infected and treatment. Here, we review laboratory methods for the diagnosis of CT, with emphasis on serological tools. A diagnostic algorithm that takes into account maternal history is presented. PMID:27147724

Visualization techniques for tongue analysis in traditional Chinese medicine

NASA Astrophysics Data System (ADS)

Pham, Binh L.; Cai, Yang

2004-05-01

Visual inspection of the tongue has been an important diagnostic method of Traditional Chinese Medicine (TCM). Clinic data have shown significant connections between various viscera cancers and abnormalities in the tongue and the tongue coating. Visual inspection of the tongue is simple and inexpensive, but the current practice in TCM is mainly experience-based and the quality of the visual inspection varies between individuals. The computerized inspection method provides quantitative models to evaluate color, texture and surface features on the tongue. In this paper, we investigate visualization techniques and processes to allow interactive data analysis with the aim to merge computerized measurements with human expert's diagnostic variables based on five-scale diagnostic conditions: Healthy (H), History Cancers (HC), History of Polyps (HP), Polyps (P) and Colon Cancer (C).

Cause and Effect: Testing a Mechanism and Method for the Cognitive Integration of Basic Science.

PubMed

Kulasegaram, Kulamakan; Manzone, Julian C; Ku, Cheryl; Skye, Aimee; Wadey, Veronica; Woods, Nicole N

2015-11-01

Methods of integrating basic science with clinical knowledge are still debated in medical training. One possibility is increasing the spatial and temporal proximity of clinical content to basic science. An alternative model argues that teaching must purposefully expose relationships between the domains. The authors compared different methods of integrating basic science: causal explanations linking basic science to clinical features, presenting both domains separately but in proximity, and simply presenting clinical features First-year undergraduate health professions students were randomized to four conditions: (1) science-causal explanations (SC), (2) basic science before clinical concepts (BC), (3) clinical concepts before basic science (CB), and (4) clinical features list only (FL). Based on assigned conditions, participants were given explanations for four disorders in neurology or rheumatology followed by a memory quiz and diagnostic test consisting of 12 cases which were repeated after one week. Ninety-four participants completed the study. No difference was found on memory test performance, but on the diagnostic test, a condition by time interaction was found (F[3,88] = 3.05, P < .03, ηp = 0.10). Although all groups had similar immediate performance, the SC group had a minimal decrease in performance on delayed testing; the CB and FL groups had the greatest decreases. These results suggest that creating proximity between basic science and clinical concepts may not guarantee cognitive integration. Although cause-and-effect explanations may not be possible for all domains, making explicit and specific connections between domains will likely facilitate the benefits of integration for learners.

Diagnosis of neglected tropical diseases among patients with persistent digestive disorders (diarrhoea and/or abdominal pain ≥14 days): Pierrea multi-country, prospective, non-experimental case-control study.

PubMed

Polman, Katja; Becker, Sören L; Alirol, Emilie; Bhatta, Nisha K; Bhattarai, Narayan R; Bottieau, Emmanuel; Bratschi, Martin W; Burza, Sakib; Coulibaly, Jean T; Doumbia, Mama N; Horié, Ninon S; Jacobs, Jan; Khanal, Basudha; Landouré, Aly; Mahendradhata, Yodi; Meheus, Filip; Mertens, Pascal; Meyanti, Fransiska; Murhandarwati, Elsa H; N'Goran, Eliézer K; Peeling, Rosanna W; Ravinetto, Raffaella; Rijal, Suman; Sacko, Moussa; Saye, Rénion; Schneeberger, Pierre H H; Schurmans, Céline; Silué, Kigbafori D; Thobari, Jarir A; Traoré, Mamadou S; van Lieshout, Lisette; van Loen, Harry; Verdonck, Kristien; von Müller, Lutz; Yansouni, Cédric P; Yao, Joel A; Yao, Patrick K; Yap, Peiling; Boelaert, Marleen; Chappuis, François; Utzinger, Jürg

2015-08-18

Diarrhoea still accounts for considerable mortality and morbidity worldwide. The highest burden is concentrated in tropical areas where populations lack access to clean water, adequate sanitation and hygiene. In contrast to acute diarrhoea (<14 days), the spectrum of pathogens that may give rise to persistent diarrhoea (≥14 days) and persistent abdominal pain is poorly understood. It is conceivable that pathogens causing neglected tropical diseases play a major role, but few studies investigated this issue. Clinical management and diagnostic work-up of persistent digestive disorders in the tropics therefore remain inadequate. Hence, important aspects regarding the pathogenesis, epidemiology, clinical symptomatology and treatment options for patients presenting with persistent diarrhoea and persistent abdominal pain should be investigated in multi-centric clinical studies. This multi-country, prospective, non-experimental case-control study will assess persistent diarrhoea (≥14 days; in individuals aged ≥1 year) and persistent abdominal pain (≥14 days; in children/adolescents aged 1-18 years) in up to 2000 symptomatic patients and 2000 matched controls. Subjects from Côte d'Ivoire, Indonesia, Mali and Nepal will be clinically examined and interviewed using a detailed case report form. Additionally, each participant will provide a stool sample that will be examined using a suite of diagnostic methods (i.e., microscopic techniques, rapid diagnostic tests, stool culture and polymerase chain reaction) for the presence of bacterial and parasitic pathogens. Treatment will be offered to all infected participants and the clinical treatment response will be recorded. Data obtained will be utilised to develop patient-centred clinical algorithms that will be validated in primary health care centres in the four study countries in subsequent studies. Our research will deepen the understanding of the importance of persistent diarrhoea and related digestive disorders in the tropics. A diversity of intestinal pathogens will be assessed for potential associations with persistent diarrhoea and persistent abdominal pain. Different diagnostic methods will be compared, clinical symptoms investigated and diagnosis-treatment algorithms developed for validation in selected primary health care centres. The findings from this study will improve differential diagnosis and evidence-based clinical management of digestive syndromes in the tropics. ClinicalTrials.gov; identifier: NCT02105714 .

Application of gray level mapping in computed tomographic colonography: a pilot study to compare with traditional surface rendering method for identification and differentiation of endoluminal lesions

PubMed Central

Chen, Lih-Shyang; Hsu, Ta-Wen; Chang, Shu-Han; Lin, Chih-Wen; Chen, Yu-Ruei; Hsieh, Chin-Chiang; Han, Shu-Chen; Chang, Ku-Yaw; Hou, Chun-Ju

2017-01-01

Objective: In traditional surface rendering (SR) computed tomographic endoscopy, only the shape of endoluminal lesion is depicted without gray-level information unless the volume rendering technique is used. However, volume rendering technique is relatively slow and complex in terms of computation time and parameter setting. We use computed tomographic colonography (CTC) images as examples and report a new visualization technique by three-dimensional gray level mapping (GM) to better identify and differentiate endoluminal lesions. Methods: There are 33 various endoluminal cases from 30 patients evaluated in this clinical study. These cases were segmented using gray-level threshold. The marching cube algorithm was used to detect isosurfaces in volumetric data sets. GM is applied using the surface gray level of CTC. Radiologists conducted the clinical evaluation of the SR and GM images. The Wilcoxon signed-rank test was used for data analysis. Results: Clinical evaluation confirms GM is significantly superior to SR in terms of gray-level pattern and spatial shape presentation of endoluminal cases (p < 0.01) and improves the confidence of identification and clinical classification of endoluminal lesions significantly (p < 0.01). The specificity and diagnostic accuracy of GM is significantly better than those of SR in diagnostic performance evaluation (p < 0.01). Conclusion: GM can reduce confusion in three-dimensional CTC and well correlate CTC with sectional images by the location as well as gray-level value. Hence, GM increases identification and differentiation of endoluminal lesions, and facilitates diagnostic process. Advances in knowledge: GM significantly improves the traditional SR method by providing reliable gray-level information for the surface points and is helpful in identification and differentiation of endoluminal lesions according to their shape and density. PMID:27925483

Cutaneous Leishmaniasis in Khyber Pakhtunkhwa Province of Pakistan: Clinical Diversity and Species-Level Diagnosis

PubMed Central

Khan, Nazma Habib; Bari, Arfan ul; Hashim, Rizwan; Khan, Inamullah; Muneer, Akhtar; Shah, Akram; Wahid, Sobia; Yardley, Vanessa; O'Neil, Brighid; Sutherland, Colin J.

2016-01-01

This study primarily aimed to identify the causative species of cutaneous leishmaniasis (CL) in the Khyber Pakhtunkhwa Province of Pakistan and to distinguish any species-specific variation in clinical manifestation of CL. Diagnostic performance of different techniques for identifying CL was assessed. Isolates of Leishmania spp. were detected by in vitro culture, polymerase chain reaction (PCR) on DNA extracted from dried filter papers and microscopic examination of direct lesion smears from patients visiting three major primary care hospitals in Peshawar. A total of 125 CL patients were evaluated. Many acquired the disease from Peshawar and the neighboring tribal area of Khyber Agency. Military personnel acquired CL while deployed in north and south Waziristan. Leishmania tropica was identified as the predominant infecting organism in this study (89.2%) followed by Leishmania major (6.8%) and, unexpectedly, Leishmania infantum (4.1%). These were the first reported cases of CL caused by L. infantum in Pakistan. PCR diagnosis targeting kinetoplast DNA was the most sensitive diagnostic method, identifying 86.5% of all samples found positive by any other method. Other methods were as follows: ribosomal DNA PCR (78.4%), internal transcribed spacer 2 region PCR (70.3%), culture (67.1%), and microscopy (60.5%). Clinical examination reported 14 atypical forms of CL. Atypical lesions were not significantly associated with the infecting Leishmania species, nor with “dry” or “wet” appearance of lesions. Findings from this study provide a platform for species typing of CL patients in Pakistan, utilizing a combination of in vitro culture and molecular diagnostics. Moreover, the clinical diversity described herein can benefit clinicians in devising differential diagnosis of the disease. PMID:27601518

[Thinking about the present primary open angle glaucoma early diagnosis concepts and methods].

PubMed

Ren, Zeqin

2014-05-01

Early diagnosis of primary open-angle glaucoma has not been clear and consistent in concepts and methods. At present, according to the pathophysiology process of optic nerve damage and its detection technology, early diagnosis on the concept still belongs to the early clinical diagnosis instead of preclinical diagnosis, and on the method depends on the fundus as morphological index combined with the visual field as functional index. The direction of early clinical diagnosis mainly lies in exploring more effective diagnosis index, rather than blindly adopt new diagnostic technology.

DNA decontamination methods for internal quality management in clinical PCR laboratories.

PubMed

Wu, Yingping; Wu, Jianyong; Zhang, Zhihui; Cheng, Chen

2018-03-01

The polymerase chain reaction (PCR) technique, one of the most commonly applied methods in diagnostic and molecular biology, has a frustrating downside: the occurrence of false-positive signals due to contamination. In previous research, various DNA decontamination methods have been developed to overcome this limitation. Unfortunately, the use of random or poorly focused sampling methods for monitoring air and/or object surfaces leads to the incomplete elimination during decontamination procedures. We herein attempted to develop a novel DNA decontamination method (environmental surveillance, including surface and air sampling) and quality management program for clinical molecular diagnostic laboratories (or clinical PCR laboratories). Here, we performed a step-by-step evaluation of current DNA decontamination methods and developed an effective procedure for assessing the presence of decontaminating DNA via PCR analysis. Performing targeted environmental surveillance by sampling, which reached optimal performance over 2 weeks, and the decontamination process had been verified as reliable. Additionally, the process was validated to not affect PCR amplification efficiency based on a comparative study. In this study, effective guidelines for DNA decontamination were developed. The method employed ensured that surface DNA contamination could be effectively identified and eliminated. Furthermore, our study highlighted the importance of overall quality assurance and good clinical laboratory practices for preventing contamination, which are key factors for compliance with regulatory or accreditation requirements. Taken together, we provided the evidence that the presented scheme ranged from troubleshooting to the elimination of surface contamination, could serve as critical foundation for developing regular environmental surveillance guidelines for PCR laboratories. © 2017 Wiley Periodicals, Inc.

The Importance of Considering Clinical Utility in the Construction of a Diagnostic Manual.

PubMed

Mullins-Sweatt, Stephanie N; Lengel, Gregory J; DeShong, Hilary L

2016-01-01

The development of major diagnostic manuals primarily has been guided by construct validity rather than clinical utility. The purpose of this article is to summarize recent research and theory examining the importance of clinical utility when constructing and evaluating a diagnostic manual. We suggest that construct validity is a necessary but not sufficient criterion for diagnostic constructs. This article discusses components of clinical utility and how these have applied to the current and forthcoming diagnostic manuals. Implications and suggestions for future research are provided.

Validation of wet mount microscopy against Trichomonas culture among women of reproductive age group in Western province, Sri Lanka.

PubMed

Banneheke, H; Fernandopulle, R; Gunasekara, U; Barua, A; Fernando, N; Wickremasinghe, R

2015-06-01

Wet mount microscopy is the most commonly used diagnostic method for trichomoniasis in clinical diagnostic services all over the world including Sri Lanka due to its availability, simplicity and is relatively inexpensive. However, Trichomonas culture and PCR are the gold standard tests. Unfortunately, neither the culture nor PCR is available for the diagnosis of trichomoniasis in Sri Lanka. Thus, it is important to validate the wet mount microscopy as it is the only available diagnostic test and has not been validated to date in Sri Lanka. The objective was to evaluate the validity and reliability of wet mount microscopy against gold standard Trichomonas culture among clinic based population of reproductive age group women in Western province, Sri Lanka. Women attending hospital and institutional based clinics were enrolled. They were interviewed and high vaginal swabs were taken for laboratory diagnosis by culture and wet mount microscopy. There were 601 participants in the age group of 15-45 years. Wet mount microscopy showed 68% sensitivity, 100% specificity, 100% positive (PPV) and 98% negative predictive values (NPV) (P=0.001, kappa=0.803) respectively against the gold standard culture. The area under the ROC curve was 0.840. Sensitivity of wet mount microscopy is low. However it has high validity and reliability as a specific diagnostic test for trichomoniasis. If it is to be used among women of reproductive age group in Western province, Sri Lanka, a culture method could be adopted as a second test to confirm the negative wet mount for symptomatic patients.

Interviewer-Perceived Honesty Mediates Racial Disparities in the Diagnosis of Schizophrenia

PubMed Central

Eack, Shaun M.; Bahorik, Amber L.; Newhill, Christina E.; Neighbors, Harold W.; Davis, Larry E.

2013-01-01

Objective African Americans are disproportionately diagnosed with schizophrenia, and the factors that contribute to this disparity are poorly understood. This study utilized data from the 1995 MacArthur Violence Risk Assessment Study to examine the impact of racial differences in sociodemographic characteristics, clinical presentation, and research interviewer perceptions of honesty on disparities in the diagnosis of schizophrenia in African Americans. Method African Americans (n = 215) and whites (n = 537) with severe mental illness receiving inpatient care were administered structured diagnostic, sociodemographic, and clinical measures during hospitalization. Assessments of interviewer-perceived honesty during diagnostic interviews were used to characterize interviewer perceptions of the patient, and their impact on racial disparities in the diagnosis of schizophrenia. Results African Americans were over three times as likely to be diagnosed with schizophrenia (n = 97, 45%) compared to whites (n = 101, 19%). Disparities in sociodemographic and clinical characteristics modestly contributed to disparities in diagnostic rates. In contrast, interviewer-perceived honesty proved to be a significant predictor of racial disparities in schizophrenia diagnoses that when accounted for, substantially reduced diagnostic disparities between African Americans and whites. Mediator analyses confirmed that interviewer-perceived honesty was the only consistent mediator of the relationship between race and schizophrenia diagnosis. Conclusions Interviewer perceptions patient honesty are important contributors to disparities in the diagnosis of schizophrenia among African Americans, and may be reflective of poor patient-clinician relationships. Methods of facilitating a trusting relationship between patients and clinicians are needed to improve the assessment and treatment of minorities seeking mental health care. PMID:22751938

Exploration of analysis methods for diagnostic imaging tests: problems with ROC AUC and confidence scores in CT colonography.

PubMed

Mallett, Susan; Halligan, Steve; Collins, Gary S; Altman, Doug G

2014-01-01

Different methods of evaluating diagnostic performance when comparing diagnostic tests may lead to different results. We compared two such approaches, sensitivity and specificity with area under the Receiver Operating Characteristic Curve (ROC AUC) for the evaluation of CT colonography for the detection of polyps, either with or without computer assisted detection. In a multireader multicase study of 10 readers and 107 cases we compared sensitivity and specificity, using radiological reporting of the presence or absence of polyps, to ROC AUC calculated from confidence scores concerning the presence of polyps. Both methods were assessed against a reference standard. Here we focus on five readers, selected to illustrate issues in design and analysis. We compared diagnostic measures within readers, showing that differences in results are due to statistical methods. Reader performance varied widely depending on whether sensitivity and specificity or ROC AUC was used. There were problems using confidence scores; in assigning scores to all cases; in use of zero scores when no polyps were identified; the bimodal non-normal distribution of scores; fitting ROC curves due to extrapolation beyond the study data; and the undue influence of a few false positive results. Variation due to use of different ROC methods exceeded differences between test results for ROC AUC. The confidence scores recorded in our study violated many assumptions of ROC AUC methods, rendering these methods inappropriate. The problems we identified will apply to other detection studies using confidence scores. We found sensitivity and specificity were a more reliable and clinically appropriate method to compare diagnostic tests.

Recent advances in diagnostic microbiology.

PubMed

Bravo, Lulette Tricia C; Procop, Gary W

2009-07-01

The past decade has seen a surge in the development of a variety of molecular diagnostics designed to rapidly identify or characterize medically important microorganisms. We briefly review important advances in molecular microbiology, and then discuss specific assays that have been implemented in clinical microbiology laboratories throughout the country. We also discuss emerging methods and technologies that will soon be more widely used for the prompt and accurate detection of the agents of infectious diseases.

Clinical applications of breath testing

PubMed Central

Paschke, Kelly M; Mashir, Alquam

2010-01-01

Breath testing has the potential to benefit the medical field as a cost-effective, non-invasive diagnostic tool for diseases of the lung and beyond. With growing evidence of clinical worth, standardization of methods, and new sensor and detection technologies the stage is set for breath testing to gain considerable attention and wider application in upcoming years. PMID:21173863

Family Cognitive Behavioral Therapy for Children and Adolescents with Clinical Anxiety Disorders

ERIC Educational Resources Information Center

Bogels, Susan M.; Siqueland, Lynne

2006-01-01

Objective: A family cognitive-behavioral therapy for children and adolescents ages 8 to 18 years with clinical anxiety disorders was developed and evaluated. Method: Seventeen families were measured before and after waitlist, after treatment, and at 3-month and 1-year follow-up. Results: No children changed their diagnostic status during waitlist,…

Inadequate Diagnostic Evaluation in Young Patients Registered with a Diagnosis of Dementia: A Nationwide Register-Based Study

PubMed Central

Salem, Lise Cronberg; Andersen, Birgitte Bo; Nielsen, T. Rune; Stokholm, Jette; Jørgensen, Martin Balslev; Waldemar, Gunhild

2014-01-01

Background Establishing a diagnosis of dementia in young patients may be complex and have significant implications for the patient. The aim of this study was to evaluate the quality of the diagnostic work-up in young patients diagnosed with dementia in the clinical routine. Methods Two hundred patients were randomly selected from 891 patients aged ≤65 years registered with a diagnosis of dementia for the first time in 2008 in Danish hospitals, and 159 medical records were available for review. Three raters evaluated their medical records for the completeness of the diagnostic work-up on which the diagnosis of dementia had been based, using evidence-based guidelines for the diagnostic evaluation of dementia as reference standards. Results According to the rater review, only 111 (70%) patients met the clinical criteria for dementia. An acceptable diagnostic work-up including all items of recommended basic diagnostic evaluation was performed in only 24%, although more often (28%) in the subgroup of patients where dementia was confirmed by raters. Conclusion This first nationwide study of unselected young patients registered with a diagnosis of dementia indicated that the concept of dementia may be misinterpreted by clinicians and that a diagnosis of dementia in the young is only rarely based on a complete basic diagnostic work-up, calling for increased competency. PMID:24711812

A Comparison of DSM-IV PDD and DSM-5 ASD Prevalence in an Epidemiologic Sample

PubMed Central

Kim, Young Shin; Fombonne, Eric; Koh, Yun-Joo; Kim, Soo-Jeong; Cheon, Keun-Ah; Leventhal, Bennett

2014-01-01

Objective Changes in autism diagnostic criteria found in DSM5 may affect Autism Spectrum Disorder (ASD) prevalence, research findings, diagnostic processes and eligibility for clinical and other services. Utilizing our published, total-population Korean prevalence data, we compute DSM5 ASD and Social Communication Disorder (SCD) prevalence and compare them to DSMIV Pervasive Developmental Disorder (PDD) prevalence estimates. We also describe individuals previously diagnosed with DSMIV PDD when diagnoses change with DSM-5 criteria. Method The target population was all 7-12-year-old children in a South Korean community (N= 55,266), those in regular and special education schools and a disability registry. We utilized the Autism Spectrum Screening Questionnaire for systematic, multi-informant screening. Parents of screen-positive children were offered comprehensive assessments using standardized diagnostic procedures, including the Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule. Best estimate clinical diagnoses were made using DSMIV PDD and DSM5 ASD and SCD criteria. Results DSM5 ASD estimated prevalence is 2.20% (CI: 1.77-3.64). Combined DSM-5 ASD and SCD prevalence is virtually same as DSM-IV PDD prevalence (2.64%). Most children with Autistic Disorder (99%), Asperger Disorder (92%), and PDD NOS (63%) met DSM-5 ASD criteria, whereas 1%, 8% and 32%, respectively, met SCD criteria. All remaining children (2% ) had other psychopathology, principally Attention Deficit Hyperactivity Disorder and anxiety disorder. Conclusion Our findings suggest that most individuals with a prior DSMIV PDD meet DSM5 diagnostic criteria for ASD and SCD. PDD, ASD or SCD, extant diagnostic criteria identify a large, clinically meaningful group of individuals and families who require evidence-based services. PMID:24745950

DIAGNOSTIC ACCURACY OF PHYSICAL EXAMINATION TESTS OF THE ANKLE/FOOT COMPLEX: A SYSTEMATIC REVIEW

PubMed Central

Schwieterman, Braun; Haas, Deniele; Columber, Kirby; Knupp, Darren

2013-01-01

Background: Orthopedic special tests of the ankle/foot complex are routinely used during the physical examination process in order to help diagnose ankle/lower leg pathologies. Purpose: The purpose of this systematic review was to investigate the diagnostic accuracy of ankle/lower leg special tests. Methods: A search of the current literature was conducted using PubMed, CINAHL, SPORTDiscus, ProQuest Nursing and Allied Health Sources, Scopus, and Cochrane Library. Studies were eligible if they included the following: 1) a diagnostic clinical test of musculoskeletal pathology in the ankle/foot complex, 2) description of the clinical test or tests, 3) a report of the diagnostic accuracy of the clinical test (e.g. sensitivity and specificity), and 4) an acceptable reference standard for comparison. The quality of included studies was determined by two independent reviewers using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Results: Nine diagnostic accuracy studies met the inclusion criteria for this systematic review; analyzing a total of 16 special tests of the ankle/foot complex. After assessment using the QUADAS-2, only one study had low risk of bias and low concerns regarding applicability. Conclusion: Most ankle/lower leg orthopedic special tests are confirmatory in nature and are best utilized at the end of the physical examination. Most of the studies included in this systematic review demonstrate notable biases, which suggest that results and recommendations in this review should be taken as a guide rather than an outright standard. There is need for future research with more stringent study design criteria so that more accurate diagnostic power of ankle/lower leg special tests can be determined. Level of Evidence: 3a PMID:24175128

Method for accurate registration of tissue autofluorescence imaging data with corresponding histology: a means for enhanced tumor margin assessment

NASA Astrophysics Data System (ADS)

Unger, Jakob; Sun, Tianchen; Chen, Yi-Ling; Phipps, Jennifer E.; Bold, Richard J.; Darrow, Morgan A.; Ma, Kwan-Liu; Marcu, Laura

2018-01-01

An important step in establishing the diagnostic potential for emerging optical imaging techniques is accurate registration between imaging data and the corresponding tissue histopathology typically used as gold standard in clinical diagnostics. We present a method to precisely register data acquired with a point-scanning spectroscopic imaging technique from fresh surgical tissue specimen blocks with corresponding histological sections. Using a visible aiming beam to augment point-scanning multispectral time-resolved fluorescence spectroscopy on video images, we evaluate two different markers for the registration with histology: fiducial markers using a 405-nm CW laser and the tissue block's outer shape characteristics. We compare the registration performance with benchmark methods using either the fiducial markers or the outer shape characteristics alone to a hybrid method using both feature types. The hybrid method was found to perform best reaching an average error of 0.78±0.67 mm. This method provides a profound framework to validate diagnostical abilities of optical fiber-based techniques and furthermore enables the application of supervised machine learning techniques to automate tissue characterization.

Point-of-care testing in the early diagnosis of acute pesticide intoxication: The example of paraquat.

PubMed

Wei, Ting-Yen; Yen, Tzung-Hai; Cheng, Chao-Min

2018-01-01

Acute pesticide intoxication is a common method of suicide globally. This article reviews current diagnostic methods and makes suggestions for future development. In the case of paraquat intoxication, it is characterized by multi-organ failure, causing substantial mortality and morbidity. Early diagnosis may save the life of a paraquat intoxication patient. Conventional paraquat intoxication diagnostic methods, such as symptom review and urine sodium dithionite assay, are time-consuming and impractical in resource-scarce areas where most intoxication cases occur. Several experimental and clinical studies have shown the potential of portable Surface Enhanced Raman Scattering (SERS), paper-based devices, and machine learning for paraquat intoxication diagnosis. Portable SERS and new SERS substrates maintain the sensitivity of SERS while being less costly and more convenient than conventional SERS. Paper-based devices provide the advantages of price and portability. Machine learning algorithms can be implemented as a mobile phone application and facilitate diagnosis in resource-limited areas. Although these methods have not yet met all features of an ideal diagnostic method, the combination and development of these methods offer much promise.

Meta-analysis of diagnostic test data: a bivariate Bayesian modeling approach.

PubMed

Verde, Pablo E

2010-12-30

In the last decades, the amount of published results on clinical diagnostic tests has expanded very rapidly. The counterpart to this development has been the formal evaluation and synthesis of diagnostic results. However, published results present substantial heterogeneity and they can be regarded as so far removed from the classical domain of meta-analysis, that they can provide a rather severe test of classical statistical methods. Recently, bivariate random effects meta-analytic methods, which model the pairs of sensitivities and specificities, have been presented from the classical point of view. In this work a bivariate Bayesian modeling approach is presented. This approach substantially extends the scope of classical bivariate methods by allowing the structural distribution of the random effects to depend on multiple sources of variability. Meta-analysis is summarized by the predictive posterior distributions for sensitivity and specificity. This new approach allows, also, to perform substantial model checking, model diagnostic and model selection. Statistical computations are implemented in the public domain statistical software (WinBUGS and R) and illustrated with real data examples. Copyright © 2010 John Wiley & Sons, Ltd.

Morphometrical study on senile larynx.

PubMed

Zieliński, R

2001-01-01

The aim of the study was a morphometrical macroscopic evaluation of senile larynges, according to its usefulness in ORL diagnostic and operational methods. Larynx preparations were taken from cadavers of both sexes, of age 65 and over, about 24 hours after death. Clinically important laryngeal diameters were collected using common morphometrical methods. A few body features were also being gathered. Computer statistical methods were used in data assessment, including basic statistics and linear correlations between diameters and between diameters and body features. The data presented in the study may be very helpful in evaluation of diagnostic methods. It may also help in selection of right operational tool' sizes, the most appropriate operational technique choice, preoperative preparations and designing and building virtual and plastic models for physicians' training.

Assessing clinical reasoning (ASCLIRE): Instrument development and validation.

PubMed

Kunina-Habenicht, Olga; Hautz, Wolf E; Knigge, Michel; Spies, Claudia; Ahlers, Olaf

2015-12-01

Clinical reasoning is an essential competency in medical education. This study aimed at developing and validating a test to assess diagnostic accuracy, collected information, and diagnostic decision time in clinical reasoning. A norm-referenced computer-based test for the assessment of clinical reasoning (ASCLIRE) was developed, integrating the entire clinical decision process. In a cross-sectional study participants were asked to choose as many diagnostic measures as they deemed necessary to diagnose the underlying disease of six different cases with acute or sub-acute dyspnea and provide a diagnosis. 283 students and 20 content experts participated. In addition to diagnostic accuracy, respective decision time and number of used relevant diagnostic measures were documented as distinct performance indicators. The empirical structure of the test was investigated using a structural equation modeling approach. Experts showed higher accuracy rates and lower decision times than students. In a cross-sectional comparison, the diagnostic accuracy of students improved with the year of study. Wrong diagnoses provided by our sample were comparable to wrong diagnoses in practice. We found an excellent fit for a model with three latent factors-diagnostic accuracy, decision time, and choice of relevant diagnostic information-with diagnostic accuracy showing no significant correlation with decision time. ASCLIRE considers decision time as an important performance indicator beneath diagnostic accuracy and provides evidence that clinical reasoning is a complex ability comprising diagnostic accuracy, decision time, and choice of relevant diagnostic information as three partly correlated but still distinct aspects.

Salivary biomarker development using genomic, proteomic and metabolomic approaches

PubMed Central

2012-01-01

The use of saliva as a diagnostic sample provides a non-invasive, cost-efficient method of sample collection for disease screening without the need for highly trained professionals. Saliva collection is far more practical and safe compared with invasive methods of sample collection, because of the infection risk from contaminated needles during, for example, blood sampling. Furthermore, the use of saliva could increase the availability of accurate diagnostics for remote and impoverished regions. However, the development of salivary diagnostics has required technical innovation to allow stabilization and detection of analytes in the complex molecular mixture that is saliva. The recent development of cost-effective room temperature analyte stabilization methods, nucleic acid pre-amplification techniques and direct saliva transcriptomic analysis have allowed accurate detection and quantification of transcripts found in saliva. Novel protein stabilization methods have also facilitated improved proteomic analyses. Although candidate biomarkers have been discovered using epigenetic, transcriptomic, proteomic and metabolomic approaches, transcriptomic analyses have so far achieved the most progress in terms of sensitivity and specificity, and progress towards clinical implementation. Here, we review recent developments in salivary diagnostics that have been accomplished using genomic, transcriptomic, proteomic and metabolomic approaches. PMID:23114182

Nanolock-Nanopore Facilitated Digital Diagnostics of Cancer Driver Mutation in Tumor Tissue.

PubMed

Wang, Yong; Tian, Kai; Shi, Ruicheng; Gu, Amy; Pennella, Michael; Alberts, Lindsey; Gates, Kent S; Li, Guangfu; Fan, Hongxin; Wang, Michael X; Gu, Li-Qun

2017-07-28

Cancer driver mutations are clinically significant biomarkers. In precision medicine, accurate detection of these oncogenic changes in patients would enable early diagnostics of cancer, individually tailored targeted therapy, and precise monitoring of treatment response. Here we investigated a novel nanolock-nanopore method for single-molecule detection of a serine/threonine protein kinase gene BRAF V600E mutation in tumor tissues of thyroid cancer patients. The method lies in a noncovalent, mutation sequence-specific nanolock. We found that the nanolock formed on the mutant allele/probe duplex can separate the duplex dehybridization procedure into two sequential steps in the nanopore. Remarkably, this stepwise unzipping kinetics can produce a unique nanopore electric marker, with which a single DNA molecule of the cancer mutant allele can be unmistakably identified in various backgrounds of the normal wild-type allele. The single-molecule sensitivity for mutant allele enables both binary diagnostics and quantitative analysis of mutation occurrence. In the current configuration, the method can detect the BRAF V600E mutant DNA lower than 1% in the tumor tissues. The nanolock-nanopore method can be adapted to detect a broad spectrum of both transversion and transition DNA mutations, with applications from diagnostics to targeted therapy.

Application of Multilabel Learning Using the Relevant Feature for Each Label in Chronic Gastritis Syndrome Diagnosis

PubMed Central

Liu, Guo-Ping; Yan, Jian-Jun; Wang, Yi-Qin; Fu, Jing-Jing; Xu, Zhao-Xia; Guo, Rui; Qian, Peng

2012-01-01

Background. In Traditional Chinese Medicine (TCM), most of the algorithms are used to solve problems of syndrome diagnosis that only focus on one syndrome, that is, single label learning. However, in clinical practice, patients may simultaneously have more than one syndrome, which has its own symptoms (signs). Methods. We employed a multilabel learning using the relevant feature for each label (REAL) algorithm to construct a syndrome diagnostic model for chronic gastritis (CG) in TCM. REAL combines feature selection methods to select the significant symptoms (signs) of CG. The method was tested on 919 patients using the standard scale. Results. The highest prediction accuracy was achieved when 20 features were selected. The features selected with the information gain were more consistent with the TCM theory. The lowest average accuracy was 54% using multi-label neural networks (BP-MLL), whereas the highest was 82% using REAL for constructing the diagnostic model. For coverage, hamming loss, and ranking loss, the values obtained using the REAL algorithm were the lowest at 0.160, 0.142, and 0.177, respectively. Conclusion. REAL extracts the relevant symptoms (signs) for each syndrome and improves its recognition accuracy. Moreover, the studies will provide a reference for constructing syndrome diagnostic models and guide clinical practice. PMID:22719781

A Practical Clinical Approach to Diagnosis of Fetal Alcohol Spectrum Disorders: Clarification of the 1996 Institute of Medicine Criteria

PubMed Central

Eugene Hoyme, H.; May, Philip A.; Kalberg, Wendy O.; Kodituwakku, Piyadasa; Phillip Gossage, J.; Trujillo, Phyllis M.; Buckley, David G.; Miller, Joseph H.; Aragon, Alfredo S.; Khaole, Nathaniel; Viljoen, Denis L.; Jones, Kenneth Lyons; Robinson, Luther K.

2006-01-01

Background. The adverse effects of alcohol on the developing human represent a spectrum of structural anomalies and behavioral and neurocognitive disabilities, most accurately termed fetal alcohol spectrum disorders (FASD). The first descriptions in the modern medical literature of a distinctly recognizable pattern of malformations associated with maternal alcohol abuse were reported in 1968 and 1973. Since that time, substantial progress has been made in developing specific criteria for defining and diagnosing this condition. Two sets of diagnostic criteria are now used most widely for evaluation of children with potential diagnoses in the FASD continuum, ie, the 1996 Institute of Medicine (IOM) criteria and the Washington criteria. Although both approaches have improved the clinical delineation of FASD, both suffer from significant drawbacks in their practical application in pediatric practice. Objective. The purpose of this report is to present specific clarifications of the 1996 IOM criteria for the diagnosis of FASD, to facilitate their practical application in clinical pediatric practice. Methods. A large cohort of children who were prenatally exposed to alcohol were identified, through active case-ascertainment methods, in 6 Native American communities in the United States and 1 community in the Western Cape Province of South Africa. The children and their families underwent standardized multidisciplinary evaluations, including a dysmorphology examination, developmental and neuropsychologic testing, and a structured maternal interview, which gathered data about prenatal drinking practices and other demographic and family information. Data for these subjects were analyzed, and revisions and clarifications of the existing IOM FASD diagnostic categories were formulated on the basis of the results. Results. The revised IOM method defined accurately and completely the spectrum of disabilities among the children in our study. On the basis of this experience, we propose specific diagnostic criteria for fetal alcohol syndrome and partial fetal alcohol syndrome. We also define alcohol-related birth defects and alcohol-related neurodevelopmental disorder from a practical standpoint. Conclusions. The 1996 IOM criteria remain the most appropriate diagnostic approach for children prenatally exposed to alcohol. The proposed revisions presented here make these criteria applicable in clinical pediatric practice. Pediatrics 2005;115:39–47; fetal alcohol syndrome, fetal alcohol spectrum disorders, diagnostic criteria, mental retardation, developmental disabilities. PMID:15629980

[Accuracy of three methods for the rapid diagnosis of oral candidiasis].

PubMed

Lyu, X; Zhao, C; Yan, Z M; Hua, H

2016-10-09

Objective: To explore a simple, rapid and efficient method for the diagnosis of oral candidiasis in clinical practice. Methods: Totally 124 consecutive patients with suspected oral candidiasis were enrolled from Department of Oral Medicine, Peking University School and Hospital of Stomatology, Beijing, China. Exfoliated cells of oral mucosa and saliva or concentrated oral rinse) obtained from all participants were tested by three rapid smear methods(10% KOH smear, gram-stained smear, Congo red stained smear). The diagnostic efficacy(sensitivity, specificity, Youden's index, likelihood ratio, consistency, predictive value and area under curve(AUC) of each of the above mentioned three methods was assessed by comparing the results with the gold standard(combination of clinical diagnosis, laboratory diagnosis and expert opinion). Results: Gram-stained smear of saliva(or concentrated oral rinse) demonstrated highest sensitivity(82.3%). Test of 10%KOH smear of exfoliated cells showed highest specificity(93.5%). Congo red stained smear of saliva(or concentrated oral rinse) displayed highest diagnostic efficacy(79.0% sensitivity, 80.6% specificity, 0.60 Youden's index, 4.08 positive likelihood ratio, 0.26 negative likelihood ratio, 80% consistency, 80.3% positive predictive value, 79.4% negative predictive value and 0.80 AUC). Conclusions: Test of Congo red stained smear of saliva(or concentrated oral rinse) could be used as a point-of-care tool for the rapid diagnosis of oral candidiasis in clinical practice. Trial registration: Chinese Clinical Trial Registry, ChiCTR-DDD-16008118.

Salivary diagnostics and its impact in dentistry, research, education, and the professional community.

PubMed

Slavkin, H C; Fox, C H; Meyer, D M

2011-10-01

Oral fluid-based (salivary) tests have the potential to create practical, point-of-care clinical instruments that are convenient, practical, and comfortable to use in dentistry and medicine. Currently, there are no simple, accurate, and inexpensive sampling, screening, or detection methods to support definitive diagnostic platforms across dental and medical disciplines. Though the benefits from advancing screening and detection technologies seem eminent, analytical, chemical, molecular, genetic, and protein markers are still under development. Clinical applications in patient care must be validated independently to ensure that they are clinically accurate, reliable, precise, and uniformly consistent for screening and detecting specific diseases or conditions. As technology designed to improve patient care through risk assessment, prevention, and disease management is transferred into clinical practice, dentistry may need to reassess its role in general health care. © International & American Associations for Dental Research

Candidate-based proteomics in the search for biomarkers of cardiovascular disease

PubMed Central

Anderson, Leigh

2005-01-01

The key concept of proteomics (looking at many proteins at once) opens new avenues in the search for clinically useful biomarkers of disease, treatment response and ageing. As the number of proteins that can be detected in plasma or serum (the primary clinical diagnostic samples) increases towards 1000, a paradoxical decline has occurred in the number of new protein markers approved for diagnostic use in clinical laboratories. This review explores the limitations of current proteomics protein discovery platforms, and proposes an alternative approach, applicable to a range of biological/physiological problems, in which quantitative mass spectrometric methods developed for analytical chemistry are employed to measure limited sets of candidate markers in large sets of clinical samples. A set of 177 candidate biomarker proteins with reported associations to cardiovascular disease and stroke are presented as a starting point for such a ‘directed proteomics’ approach. PMID:15611012

Auditory brainstem response (ABR) profiling tests as diagnostic support for schizophrenia and adult attention-deficit hyperactivity disorder (ADHD).

PubMed

Juselius Baghdassarian, Eva; Nilsson Markhed, Maria; Lindström, Eva; Nilsson, Björn M; Lewander, Tommy

2018-06-01

To evaluate the performances of two auditory brainstem response (ABR) profiling tests as potential biomarkers and diagnostic support for schizophrenia and adult attention-deficit hyperactivity disorder (ADHD), respectively, in an investigator-initiated blinded study design. Male and female patients with schizophrenia (n=26) and adult ADHD (n=24) meeting Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) diagnostic criteria and healthy controls (n=58) comprised the analysis set (n=108) of the total number of study participants (n=119). Coded sets of randomized ABR recordings were analysed by an independent party blinded to clinical diagnoses before a joint code-breaking session. The ABR profiling test for schizophrenia identified schizophrenia patients versus controls with a sensitivity of 84.6% and a specificity of 93.1%. The ADHD test identified patients with adult ADHD versus controls with a sensitivity of 87.5% and a specificity of 91.4%. The ABR profiling tests discriminated schizophrenia and ADHD versus healthy controls with high sensitivity and specificity. The methods deserve to be further explored in larger clinical studies including a broad range of psychiatric disorders to determine their utility as potential diagnostic biomarkers.

Microfluidic paper-based analytical devices for potential use in quantitative and direct detection of disease biomarkers in clinical analysis.

PubMed

Lim, Wei Yin; Goh, Boon Tong; Khor, Sook Mei

2017-08-15

Clinicians, working in the health-care diagnostic systems of developing countries, currently face the challenges of rising costs, increased number of patient visits, and limited resources. A significant trend is using low-cost substrates to develop microfluidic devices for diagnostic purposes. Various fabrication techniques, materials, and detection methods have been explored to develop these devices. Microfluidic paper-based analytical devices (μPADs) have gained attention for sensing multiplex analytes, confirming diagnostic test results, rapid sample analysis, and reducing the volume of samples and analytical reagents. μPADs, which can provide accurate and reliable direct measurement without sample pretreatment, can reduce patient medical burden and yield rapid test results, aiding physicians in choosing appropriate treatment. The objectives of this review are to provide an overview of the strategies used for developing paper-based sensors with enhanced analytical performances and to discuss the current challenges, limitations, advantages, disadvantages, and future prospects of paper-based microfluidic platforms in clinical diagnostics. μPADs, with validated and justified analytical performances, can potentially improve the quality of life by providing inexpensive, rapid, portable, biodegradable, and reliable diagnostics. Copyright © 2017 Elsevier B.V. All rights reserved.

How to Perform a Systematic Review and Meta-analysis of Diagnostic Imaging Studies.

PubMed

Cronin, Paul; Kelly, Aine Marie; Altaee, Duaa; Foerster, Bradley; Petrou, Myria; Dwamena, Ben A

2018-05-01

A systematic review is a comprehensive search, critical evaluation, and synthesis of all the relevant studies on a specific (clinical) topic that can be applied to the evaluation of diagnostic and screening imaging studies. It can be a qualitative or a quantitative (meta-analysis) review of available literature. A meta-analysis uses statistical methods to combine and summarize the results of several studies. In this review, a 12-step approach to performing a systematic review (and meta-analysis) is outlined under the four domains: (1) Problem Formulation and Data Acquisition, (2) Quality Appraisal of Eligible Studies, (3) Statistical Analysis of Quantitative Data, and (4) Clinical Interpretation of the Evidence. This review is specifically geared toward the performance of a systematic review and meta-analysis of diagnostic test accuracy (imaging) studies. Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Machine learning, medical diagnosis, and biomedical engineering research - commentary.

PubMed

Foster, Kenneth R; Koprowski, Robert; Skufca, Joseph D

2014-07-05

A large number of papers are appearing in the biomedical engineering literature that describe the use of machine learning techniques to develop classifiers for detection or diagnosis of disease. However, the usefulness of this approach in developing clinically validated diagnostic techniques so far has been limited and the methods are prone to overfitting and other problems which may not be immediately apparent to the investigators. This commentary is intended to help sensitize investigators as well as readers and reviewers of papers to some potential pitfalls in the development of classifiers, and suggests steps that researchers can take to help avoid these problems. Building classifiers should be viewed not simply as an add-on statistical analysis, but as part and parcel of the experimental process. Validation of classifiers for diagnostic applications should be considered as part of a much larger process of establishing the clinical validity of the diagnostic technique.

Experiences of intervertebral motion palpation in osteopathic practice - A qualitative interview study among Swedish osteopaths.

PubMed

Sposato, Niklas S; Bjerså, Kristofer

2017-01-01

Assessment in manual therapy includes quantitative and qualitative procedures, and intervertebral motion palpation (IMP) is one of the core assessment methods in osteopathic practice. The aim of this study was to explore osteopathic practitioners' experiences of clinical decision-making and IMP as a diagnostic tool for planning and evaluation of osteopathic interventions. The study was conducted with semi-structured interviews that included eight informants. Content analysis was used as the analytical procedure. In total, three categories emerged from the analysis: strategic decision-making, diagnostic usability of IMP, and treatment applicability of IMP. The study indicated that IMP was considered relevant and was given particular importance in cases where IMP findings confirmed clinical information attained from other stages in the diagnostic process as a whole. However, IMP findings were experienced as less important if they were not correlated to other findings. Copyright © 2016 Elsevier Ltd. All rights reserved.

An affordable and easy-to-use diagnostic method for keratoconus detection using a smartphone

NASA Astrophysics Data System (ADS)

Askarian, Behnam; Tabei, Fatemehsadat; Askarian, Amin; Chong, Jo Woon

2018-02-01

Recently, smartphones are used for disease diagnosis and healthcare. In this paper, we propose a novel affordable diagnostic method of detecting keratoconus using a smartphone. Keratoconus is usually detected in clinics with ophthalmic devices, which are large, expensive and not portable, and need to be operated by trained technicians. However, our proposed smartphone-based eye disease detection method is small, affordable, portable, and it can be operated by patients in a convenient way. The results show that the proposed keratoconus detection method detects severe, advanced, and moderate keratoconus with accuracies of 93%, 86%, 67%, respectively. Due to its convenience with these accuracies, the proposed keratoconus detection method is expected to be applied in detecting keratoconus at an earlier stage in an affordable way.

A hybrid model for combining case-control and cohort studies in systematic reviews of diagnostic tests

PubMed Central

Chen, Yong; Liu, Yulun; Ning, Jing; Cormier, Janice; Chu, Haitao

2014-01-01

Systematic reviews of diagnostic tests often involve a mixture of case-control and cohort studies. The standard methods for evaluating diagnostic accuracy only focus on sensitivity and specificity and ignore the information on disease prevalence contained in cohort studies. Consequently, such methods cannot provide estimates of measures related to disease prevalence, such as population averaged or overall positive and negative predictive values, which reflect the clinical utility of a diagnostic test. In this paper, we propose a hybrid approach that jointly models the disease prevalence along with the diagnostic test sensitivity and specificity in cohort studies, and the sensitivity and specificity in case-control studies. In order to overcome the potential computational difficulties in the standard full likelihood inference of the proposed hybrid model, we propose an alternative inference procedure based on the composite likelihood. Such composite likelihood based inference does not suffer computational problems and maintains high relative efficiency. In addition, it is more robust to model mis-specifications compared to the standard full likelihood inference. We apply our approach to a review of the performance of contemporary diagnostic imaging modalities for detecting metastases in patients with melanoma. PMID:25897179

Major Depressive Disorder with Sub-threshold Bipolarity in the National Comorbidity Survey Replication

PubMed Central

Angst, Jules; Cui, Lihong; Swendsen, J. Joel; Rothen, S.; Cravchik, Anibal; Kessler, Ronald; Merikangas, Kathleen

2011-01-01

Objectives There is growing clinical and epidemiologic evidence indicating that major mood disorders form a spectrum from Major Depressive Disorder (MDD) to pure mania. The present investigation examined the prevalence and clinical correlates of MDD with sub-threshold bipolarity vs. pure MDD in the National Comorbidity Survey Replication (NCS-R). Methods The NCS-R is a nationally representative face-to-face household survey of the U.S. population conducted between February, 2001 and April, 2003. Lifetime history of mood disorders, symptoms and clinical indicators of severity were collected using version 3.0 of the WHO Composite International Diagnostic Interview, a fully structured lay-administered diagnostic interview. Results Nearly 40% of study participants with a history of major depressive disorder had a history of sub-threshold hypomania. This subgroup had a younger age of disorder onset, more episodes of depression, and higher rates of comorbidity than those without a history of hypomania, and lower levels of clinical severity than those with bipolar II disorder. Conclusions The findings demonstrate heterogeneity of major depressive disorder and support the validity of inclusion of sub-threshold mania in the diagnostic classification. The broadening of criteria for bipolar disorder would have important implications for research and clinical practice. PMID:20713498

Clinical and public health implications of acute and early HIV detection and treatment: a scoping review

PubMed Central

Rutstein, Sarah E.; Ananworanich, Jintanat; Fidler, Sarah; Johnson, Cheryl; Sanders, Eduard J.; Sued, Omar; Saez-Cirion, Asier; Pilcher, Christopher D.; Fraser, Christophe; Cohen, Myron S.; Vitoria, Marco; Doherty, Meg; Tucker, Joseph D.

2017-01-01

Abstract Introduction: The unchanged global HIV incidence may be related to ignoring acute HIV infection (AHI). This scoping review examines diagnostic, clinical, and public health implications of identifying and treating persons with AHI. Methods: We searched PubMed, in addition to hand-review of key journals identifying research pertaining to AHI detection and treatment. We focused on the relative contribution of AHI to transmission and the diagnostic, clinical, and public health implications. We prioritized research from low- and middle-income countries (LMICs) published in the last fifteen years. Results and Discussion: Extensive AHI research and limited routine AHI detection and treatment have begun in LMIC. Diagnostic challenges include ease-of-use, suitability for application and distribution in LMIC, and throughput for high-volume testing. Risk score algorithms have been used in LMIC to screen for AHI among individuals with behavioural and clinical characteristics more often associated with AHI. However, algorithms have not been implemented outside research settings. From a clinical perspective, there are substantial immunological and virological benefits to identifying and treating persons with AHI – evading the irreversible damage to host immune systems and seeding of viral reservoirs that occurs during untreated acute infection. The therapeutic benefits require rapid initiation of antiretrovirals, a logistical challenge in the absence of point-of-care testing. From a public health perspective, AHI diagnosis and treatment is critical to: decrease transmission via viral load reduction and behavioural interventions; improve pre-exposure prophylaxis outcomes by avoiding treatment initiation for HIV-seronegative persons with AHI; and, enhance partner services via notification for persons recently exposed or likely transmitting. Conclusions: There are undeniable clinical and public health benefits to AHI detection and treatment, but also substantial diagnostic and logistical barriers to implementation and scale-up. Effective early ART initiation may be critical for HIV eradication efforts, but widespread use in LMIC requires simple and accurate diagnostic tools. Implementation research is critical to facilitate sustainable integration of AHI detection and treatment into existing health systems and will be essential for prospective evaluation of testing algorithms, point-of-care diagnostics, and efficacious and effective first-line regimens. PMID:28691435

Predictors of physician confidence to diagnose pneumonia and determine illness severity in ventilated patients. Australian and New Zealand practice in intensive care (ANZPIC II).

PubMed

Boots, R J; Lipman, J; Bellomo, R; Stephens, D; Heller, R E

2005-02-01

The manner in which elements of clinical history, physical examination and investigations influence subjectively assessed illness severity and outcome prediction is poorly understood. This study investigates the relationship between clinician and objectively assessed illness severity and the factors influencing clinician's diagnostic confidence and illness severity rating for ventilated patients with suspected pneumonia in the intensive care unit (ICU). A prospective study of fourteen ICUs included all ventilated admissions with a clinical diagnosis of pneumonia. Data collection included pneumonia type - community-acquired (CAP), hospital-acquired (HAP) and ventilator-associated (VAP), clinician determined illness severity (CDIS), diagnostic methods, clinical diagnostic confidence (CDC), microbiological isolates and antibiotic use. For 476 episodes of pneumonia (48% CAP, 24% HAP, 28% VAP), CDC was greatest for CAP (64% CAP, 50% HAP and 49% VAP, P<0.01) or when pneumonia was considered "life-threatening" (84% high CDC, 13% medium CDC and 3% low CDC, P<0. 001). "Life-threatening" pneumonia was predicted by worsening gas exchange (OR 4.8, CI 95% 2.3-10.2, P<0.001), clinical signs of consolidation (OR 2.0, CI 95% 1.2-3.2, P<0.01) and the Sepsis-Related Organ Failure Assessment (SOFA) Score (OR 1.1, CI 95% 1.1-1.2, P<0.001). Diagnostic confidence increased with CDIS (OR 16.3, CI 95% 8.4-31.4, P<0.001), definite pathogen isolation (OR 3.3, CI 95% 2.0-5.6) and clinical signs of consolidation (OR 2.1, CI 95% 1.3-3.3, P=0.001). Although the CDIS, SOFA Score and the Simplified Acute Physiologic Score (SAPS II) were all associated with mortality, the SAPS II Score was the best predictor of mortality (P = 0. 02). Diagnostic confidence for pneumonia is moderate but increases with more classical presentations. A small set of clinical parameters influence subjective assessment. Objective assessment using SAPS II Scoring is a better predictor of mortality.

Overcoming the problem of diagnostic heterogeneity in applying measurement-based care in clinical practice: the concept of psychiatric vital signs.

PubMed

Zimmerman, Mark; Young, Diane; Chelminski, Iwona; Dalrymple, Kristy; Galione, Janine N

2012-02-01

Measurement-based care refers to the use of standardized scales to measure the outcome of psychiatric treatment. Diagnostic heterogeneity poses a challenge toward the adoption of a measurement-based care approach toward outcome evaluation in clinical practice. In the present article, we propose adopting the concept of psychiatric vital signs to facilitate measurement-based care. Medical vital signs are measures of basic physiologic functions that are routinely determined in medical settings. Vital signs are often a primary outcome measure, and they are also often adjunctive measurements. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services project, we examined the frequency of depression and anxiety in a diagnostically heterogeneous group of psychiatric outpatients to determine the appropriateness of considering their measurement as psychiatric vital signs. Three thousand psychiatric outpatients were interviewed with the Structured Clinical Interview for DSM-IV supplemented with items from the Schedule for Affective Disorders and Schizophrenia. We determined the frequency of depression and anxiety evaluated according to the Schedule for Affective Disorders and Schizophrenia items. In the entire sample of 3000 patients, 79.3% (n = 2378) reported clinically significant depression of at least mild severity, 64.4% (n = 1932) reported anxiety of at least mild severity, and 87.4% (n = 2621) reported either anxiety or depression. In all 10 diagnostic categories examined, most patients had clinically significant anxiety or depression of at least mild severity. These findings support the routine assessment of anxiety and depression in clinical practice because almost all patients will have these problems as part of their initial presentation. Even for those patients without depression or anxiety, the case could be made that the measurement of depression and anxiety is relevant and analogous to measuring certain physiologic parameters in medical practice such as blood pressure and body temperature regardless of the reason for the visit. Copyright © 2012 Elsevier Inc. All rights reserved.

The STARD statement for reporting diagnostic accuracy studies: application to the history and physical examination.

PubMed

Simel, David L; Rennie, Drummond; Bossuyt, Patrick M M

2008-06-01

The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Nonsystematic review of the STARD statement. Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient's history and physical examination.

Non-invasive 13C-glucose breath test using residual gas analyzer-mass spectrometry: a novel tool for screening individuals with pre-diabetes and type 2 diabetes.

PubMed

Ghosh, Chiranjit; Maity, Abhijit; Banik, Gourab D; Som, Suman; Chakraborty, Arpita; Selvan, Chitra; Ghosh, Shibendu; Ghosh, Barnali; Chowdhury, Subhankar; Pradhan, Manik

2014-09-01

We report, for the first time, the clinical feasibility of a novel residual gas analyzer mass spectrometry (RGA-MS) method for accurate evaluation of the (13)C-glucose breath test ((13)C-GBT) in the diagnosis of pre-diabetes (PD) and type 2 diabetes mellitus (T2D). In T2D or PD, glucose uptake is impaired and results in blunted isotope enriched (13)CO2 production in exhaled breath samples. Using the Receiver operating characteristics (ROC) curve analysis, an optimal diagnostic cut-off point of the (13)CO2/(12)CO2 isotope ratios expressed as the delta-over-baseline (DOB) value, was determined to be δDOB(13)C‰ = 28.81‰ for screening individuals with non-diabetes controls (NDC) and pre-diabetes (PD), corresponding to a sensitivity of 100% and specificity of 94.4%. We also determined another optimal diagnostic cut-off point of δDOB(13)C‰ = 19.88‰ between individuals with PD and T2D, which exhibited 100% sensitivity and 95.5% specificity. Our RGA-MS methodology for the (13)C-GBT also manifested a typical diagnostic positive and negative predictive value of 96% and 100%, respectively. The diagnostic accuracy, precision and validity of the results were also confirmed by high-resolution optical cavity enhanced integrated cavity output spectroscopy (ICOS) measurements. The δDOB(13)C‰ values measured with RGA-MS method, correlated favourably (R(2) = 0.979) with those determined by the laser based ICOS method. Moreover, we observed that the effects of endogenous CO2 production related to basal metabolic rates in individuals were statistically insignificant (p = 0.37 and 0.73) on the diagnostic accuracy. Our findings suggest that the RGA-MS is a valid and sufficiently robust method for the (13)C-GBT which may serve as an alternative non-invasive point-of-care diagnostic tool for routine clinical practices as well as for large-scale diabetes screening purposes in real-time.

The Clinical Usefulness of Endoscopic Ultrasound-Guided Fine Needle Aspiration and Biopsy for Rectal and Perirectal Lesions

PubMed Central

Soh, Jae Seung; Lee, Ho-Su; Lee, Seohyun; Bae, Jungho; Lee, Hyo Jeong; Park, Sang Hyoung; Yang, Dong-Hoon; Kim, Kyung-Jo; Ye, Byong Duk; Myung, Seung-Jae; Yang, Suk-Kyun; Kim, Jin-Ho

2015-01-01

Background/Aims Endoscopic ultrasound-guided fine needle aspiration and/or biopsy (EUS-FNA/B) have been used to diagnose subepithelial tumors (SETs) and extraluminal lesions in the gastrointestinal tract. Our group previously reported the usefulness of EUS-FNA/B for rectal and perirectal lesions. This study reports our expanded experience with EUS-FNA/B for rectal and perirectal lesions in terms of diagnostic accuracy and safety. We also included our new experience with EUS-FNB using the recently introduced ProCore needle. Methods From April 2009 to March 2014, EUS-FNA/B for rectal and perirectal lesions was performed in 30 consecutive patients. We evaluated EUS-FNA/B performance by comparing histological diagnoses with final results. We also investigated factors affecting diagnostic accuracy. Results Among 10 patients with SETs, EUS-FNA/B specimen results revealed a gastrointestinal stromal tumor in 4 patients and malignant lymphoma in 1 patient. The diagnostic accuracy of EUS-FNA/B was 50% for SETs (5/10). Among 20 patients with non-SET lesions, 8 patients were diagnosed with malignant disease and 7 were diagnosed with benign disease based on both EUS-FNA/B and the final results. The diagnostic accuracy of EUS-FNA/B for non-SET lesions was 75% (15/20). The size of lesions was the only factor related to diagnostic accuracy (P=0.027). Two complications of mild fever and asymptomatic pneumoperitoneum occurred after EUS-FNA/B. Conclusions The overall diagnostic accuracy of EUS-FNA/B for rectal and perirectal lesions was 67% (20/30). EUS-FNA/B is a clinically useful method for cytological and histological diagnoses of rectal and perirectal lesions. PMID:25931998

Overcoming the errors of in-house PCR used in the clinical laboratory for the diagnosis of extrapulmonary tuberculosis.

PubMed

Kunakorn, M; Raksakai, K; Pracharktam, R; Sattaudom, C

1999-03-01

Our experiences from 1993 to 1997 in the development and use of IS6110 base PCR for the diagnosis of extrapulmonary tuberculosis in a routine clinical setting revealed that error-correcting processes can improve existing diagnostic methodology. The reamplification method initially used had a sensitivity of 90.91% and a specificity of 93.75%. The concern was focused on the false positive results of this method caused by product-carryover contamination. This method was changed to single round PCR with carryover prevention by uracil DNA glycosylase (UDG), resulting in a 100% specificity but only 63% sensitivity. Dot blot hybridization was added after the single round PCR, increasing the sensitivity to 87.50%. However, false positivity resulted from the nonspecific dot blot hybridization signal, reducing the specificity to 89.47%. The hybridization of PCR was changed to a Southern blot with a new oligonucleotide probe giving the sensitivity of 85.71% and raising the specificity to 99.52%. We conclude that the PCR protocol for routine clinical use should include UDG for carryover prevention and hybridization with specific probes to optimize diagnostic sensitivity and specificity in extrapulmonary tuberculosis testing.

Single-centre study of the diagnostic performance of plasma metanephrines with seated sampling for the diagnosis of phaeochromocytoma/paraganglioma.

PubMed

Boot, Christopher; Toole, Barry; Johnson, Sarah J; Ball, Stephen; Neely, Dermot

2017-01-01

Background Measurement of plasma metanephrines is regarded as one of the best screening tests for phaeochromocytoma/paraganglioma. Current guidelines recommend that samples are ideally collected in the supine position after 30 min rest and interpreted using supine reference ranges, in order to optimize the diagnostic performance of the test. Current practice in our centre is to collect samples for plasma metanephrines from seated patients. The aim of the study was to determine, if seated sampling for plasma metanephrines provides acceptable diagnostic performance in our centre. Methods Clinical and laboratory data of 113 patients, gathered over a four-year period 2010-2014, were reviewed. All had undergone preoperative plasma metanephrines measurement and had postoperative histopathology confirmation or exclusion of phaeochromocytoma/paraganglioma. Results Of 113 patients included in the study, 40 had a histological diagnosis of phaeochromocytoma/paraganglioma. The remaining 73 patients had an alternative adrenal pathology. The diagnostic sensitivity of normetanephrine or metanephrine above the upper limit of our in-house seated reference range was 93%. However, excluding three cases of paraganglioma determined clinically and biochemically to be non-functional raised the sensitivity to 100%. Diagnostic specificity was 90%. Applying published supine reference ranges made no difference to diagnostic sensitivity in this group of patients but decreased diagnostic specificity to 75%. Conclusions While these data are derived from a relatively small study population, they demonstrate acceptable diagnostic performance for seated plasma metanephrines as a screening test for phaeochromocytoma/paraganglioma. These data highlight a high diagnostic sensitivity for plasma metanephrines with seated sampling in our centre.

[Analysis of characteristics and influence factors of diagnostic delay of endometriosis].

PubMed

Han, X T; Guo, H Y; Kong, D L; Han, J S; Zhang, L F

2018-02-25

Objective: To access the influence factors of diagnostic delay of endometriosis. Methods: We designed a questionnaire of diagnostic delay of endometriosis. From February 2014 to February 2016, 400 patients who had dysmenorrhea and diagnosed with endometriosis by surgery in Peking University Third Hospital were surveyed retrospectively. Time and risk factors of diagnostic delay were analyzed. Results: The diagnostic delay of 400 patients was 13.0 years (0.2-43.0 years), 78.5%(314/400) patients thought pain was a normal phenomenon and didn't see the doctor. Patients who suffered dysmenorrhea at menarche experienced longer diagnostic delay than those who had dysmenorrhea after menarche (18.0 vs 4.5 years; Z= 191.800, P< 0.01) . Patients who suffered aggravating dysmenorrhea experienced shorter delay time than those who suffered stable or relieving dysmenorrhea (11.0 vs 12.5 vs 18.0 years; Z= 8.270, P< 0.05) , with the difference statistically significant, single factor analysis shows. Severe dysmenorrhea, deep infiltration endometriosis (DIE) , family history of dysmenorrhea or endometriosis, previous surgical history of endometriosis, high stage, with infertility, adenomyoma or other symptoms, could help to shorten diagnostic delay with no significant difference ( P> 0.05) . By multiple logistic regression analysis, the results shown that whether have dysmenorrhea at menarche and clinical diagnosis time were the independent factors affecting delayed diagnosis ( P< 0.01) . Conclusions: Diagnostic delay of endometriosis is common and the mean delay time is 13.0 years mainly due to the unawareness of dysmenorrhea. Dysmenorrhea at menarche, clinical diagnosis time and dysmenorrhea intensity are the factors affecting time of diagnostic delay.

Evaluation of the diagnostic yield of dental radiography and cone-beam computed tomography for the identification of anatomic landmarks in small to medium-sized brachycephalic dogs.

PubMed

Döring, Sophie; Arzi, Boaz; Barich, Catherine R; Hatcher, David C; Kass, Philip H; Verstraete, Frank J M

2018-01-01

OBJECTIVE To evaluate the diagnostic yield of dental radiography (Rad method) and 3 cone-beam CT (CBCT) methods for the identification of predefined anatomic landmarks in brachycephalic dogs. ANIMALS 19 client-owned brachycephalic dogs admitted for evaluation and treatment of dental disease. PROCEDURES 26 predefined anatomic landmarks were evaluated separately by use of the RAD method and 3 CBCT software modules (serial CBCT slices and custom cross sections, tridimensional rendering, and reconstructed panoramic views). A semiquantitative scoring system was used, and mean scores were calculated for each anatomic landmark and imaging method. The Friedman test was used to evaluate values for significant differences in diagnostic yield. For values that were significant, the Wilcoxon signed rank test was used with the Bonferroni-Holm multiple comparison adjustment to determine significant differences among each of the 6 possible pairs of diagnostic methods. RESULTS Differences of diagnostic yield among the Rad and 3 CBCT methods were significant for 19 of 26 anatomic landmarks. For these landmarks, Rad scores were significantly higher than scores for reconstructed panoramic views for 4 of 19 anatomic landmarks, but Rad scores were significantly lower than scores for reconstructed panoramic views for 8 anatomic landmarks, tridimensional rendering for 18 anatomic landmarks, and serial CBCT slices and custom cross sections for all 19 anatomic landmarks. CONCLUSIONS AND CLINICAL RELEVANCE CBCT methods were better suited than dental radiography for the identification of anatomic landmarks in brachycephalic dogs. Results of this study can serve as a basis for CBCT evaluation of dental disorders in brachycephalic dogs.

The role of modern diagnostic imaging in diagnosing and differentiating kidney diseases in children.

PubMed

Maliborski, Artur; Zegadło, Arkadiusz; Placzyńska, Małgorzata; Sopińska, Małgorzata; Lichosik, Marianna; Jobs, Katarzyna

2018-01-01

Urinary tract diseases are in the group of the most commonly diagnosed medical conditions in pediatric patients. Many diseases with different etiologies are accompanied by pain, fever, hematuria, or urinary tract dysfunction. Those most common ones in children are urinary tract infections and congenital malformation. They can also represent tumors or changes caused by systemic diseases. Clinical tests and even more often additional imaging studies are required to make a proper diagnosis of urinary tract diseases. Just a few decades ago urography, cystography or voiding cystourethrography were the main methods in diagnostic imaging of the urinary tract. Today's imaging methods supported by digital radiographic and fluoroscopy systems, high sensitivity detectors with quantum detection, advanced algorithms eliminating motion artifacts, modern medical imaging monitors with a resolution of three or even eight megapixels significantly differ from conventional radiographic methods. The methods that are currently usually performed are: computed tomography, magnetic resonance imaging, isotopic methods and ultrasonography using elastography and new solutions in Doppler imaging. Modern techniques are currently focused on reducing radiation exposure with better imaging capabilities. The development of these techniques became an essential diagnostic aid in nephrological and urological practice. The aim of this paper is to present the latest solutions that are currently used in the diagnostic imaging of urinary tract diseases.

A novel diagnostic method for malaria using loop-mediated isothermal amplification (LAMP) and MinION™ nanopore sequencer.

PubMed

Imai, Kazuo; Tarumoto, Norihito; Misawa, Kazuhisa; Runtuwene, Lucky Ronald; Sakai, Jun; Hayashida, Kyoko; Eshita, Yuki; Maeda, Ryuichiro; Tuda, Josef; Murakami, Takashi; Maesaki, Shigefumi; Suzuki, Yutaka; Yamagishi, Junya; Maeda, Takuya

2017-09-13

A simple and accurate molecular diagnostic method for malaria is urgently needed due to the limitations of conventional microscopic examination. In this study, we demonstrate a new diagnostic procedure for human malaria using loop mediated isothermal amplification (LAMP) and the MinION™ nanopore sequencer. We generated specific LAMP primers targeting the 18S-rRNA gene of all five human Plasmodium species including two P. ovale subspecies (P. falciparum, P. vivax, P. ovale wallikeri, P. ovale curtisi, P. knowlesi and P. malariae) and examined human blood samples collected from 63 malaria patients in Indonesia. Additionally, we performed amplicon sequencing of our LAMP products using MinION™ nanopore sequencer to identify each Plasmodium species. Our LAMP method allowed amplification of all targeted 18S-rRNA genes of the reference plasmids with detection limits of 10-100 copies per reaction. Among the 63 clinical samples, 54 and 55 samples were positive by nested PCR and our LAMP method, respectively. Identification of the Plasmodium species by LAMP amplicon sequencing analysis using the MinION™ was consistent with the reference plasmid sequences and the results of nested PCR. Our diagnostic method combined with LAMP and MinION™ could become a simple and accurate tool for the identification of human Plasmodium species, even in resource-limited situations.

Shoulder pain in primary care: diagnostic accuracy of clinical examination tests for non-traumatic acromioclavicular joint pain

PubMed Central

2013-01-01

Background Despite numerous methodological flaws in previous study designs and the lack of validation in primary care populations, clinical tests for identifying acromioclavicular joint (ACJ) pain are widely utilised without concern for such issues. The aim of this study was to estimate the diagnostic accuracy of traditional ACJ tests and to compare their accuracy with other clinical examination features for identifying a predominant ACJ pain source in a primary care cohort. Methods Consecutive patients with shoulder pain were recruited prospectively from primary health care clinics. Following a standardised clinical examination and diagnostic injection into the subacromial bursa, all participants received a fluoroscopically guided diagnostic block of 1% lidocaine hydrochloride (XylocaineTM) into the ACJ. Diagnostic accuracy statistics including sensitivity, specificity, predictive values, positive and negative likelihood ratios (LR+ and LR-) were calculated for traditional ACJ tests (Active Compression/O’Brien’s test, cross-body adduction, localised ACJ tenderness and Hawkins-Kennedy test), and for individual and combinations of clinical examination variables that were associated with a positive anaesthetic response (PAR) (P≤0.05) defined as 80% or more reduction in post-injection pain intensity during provocative clinical tests. Results Twenty two of 153 participants (14%) reported an 80% PAR. None of the traditional ACJ tests were associated with an 80% PAR (P<0.05) and combinations of traditional tests were not able to discriminate between a PAR and a negative anaesthetic response (AUC 0.507; 95% CI: 0.366, 0.647; P>0.05). Five clinical examination variables (repetitive mechanism of pain onset, no referred pain below the elbow, thickened or swollen ACJ, no symptom provocation during passive glenohumeral abduction and external rotation) were associated with an 80% PAR (P<0.05) and demonstrated an ability to accurately discriminate between an PAR and NAR (AUC 0.791; 95% CI 0.702, 0.880; P<0.001). Less than two positive clinical features resulted in 96% sensitivity (95% CI 0.78, 0.99) and a LR- 0.09 (95% CI 0.02, 0.41) and four positive clinical features resulted in 95% specificity (95% CI 0.90, 0.98) and a LR+ of 4.98 (95% CI 1.69, 13.84). Conclusions In this cohort of primary care patients with predominantly subacute or chronic ACJ pain of non-traumatic onset, traditional ACJ tests were of limited diagnostic value. Combinations of other history and physical examination findings were able to more accurately identify injection-confirmed ACJ pain in this cohort. PMID:23634871

The Study of Cardiovascular Health Outcomes in the Era of Claims Data: The Cardiovascular Health Study

PubMed Central

Psaty, Bruce M; Delaney, Joseph A; Arnold, Alice M; Curtis, Lesley H; Fitzpatrick, Annette L; Heckbert, Susan R; McKnight, Barbara; Ives, Diane; Gottdiener, John S; Kuller, Lewis H; Longstreth, W T

2015-01-01

Background Increasingly, the diagnostic codes from administrative claims data are being used as clinical outcomes. Methods and Results Data from the Cardiovascular Health Study (CHS) were used to compare event rates and risk-factor associations between adjudicated hospitalized cardiovascular events and claims-based methods of defining events. The outcomes of myocardial infarction (MI), stroke, and heart failure (HF) were defined in three ways: 1) the CHS adjudicated event (CHS[adj]); 2) selected ICD9 diagnostic codes only in the primary position for Medicare claims data from the Center for Medicare and Medicaid Services (CMS[1st]); and 3) the same selected diagnostic codes in any position (CMS[any]). Conventional claims-based methods of defining events had high positive predictive values (PPVs) but low sensitivities. For instance, the PPV of an ICD9 code of 410.×1 for a new acute MI in the first position was 90.6%, but this code identified only 53.8% of incident MIs. The observed event rates were low. For MI, the incidence was 14.9 events per 1000 person years for CHS[adj] MI, 8.6 for CMS[1st] and 12.2 for CMS[any]. In general, CVD risk factor associations were similar across the three methods of defining events. Indeed, traditional CVD risk factors were also associated with all first hospitalizations not due to an MI. Conclusions The use of diagnostic codes from claims data as clinical events, especially when restricted to primary diagnoses, leads to an underestimation of event rates. Additionally, claims-based events data represent a composite endpoint that includes the outcome of interest and selected (misclassified) non-event hospitalizations. PMID:26538580

Cancer Imaging Phenomics Toolkit (CaPTk) | Informatics Technology for Cancer Research (ITCR)

Cancer.gov

CaPTk is a software toolkit to facilitate translation of quantitative image analysis methods that help us obtain rich imaging phenotypic signatures of oncologic images and relate them to precision diagnostics and prediction of clinical outcomes, as well as to underlying molecular characteristics of cancer. The stand-alone graphical user interface of CaPTk brings analysis methods from the realm of medical imaging research to the clinic, and will be extended to use web-based services for computationally-demanding pipelines.

Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain

PubMed Central

Laslett, Mark; McDonald, Barry; Tropp, Hans; Aprill, Charles N; Öberg, Birgitta

2005-01-01

Background The tissue origin of low back pain (LBP) or referred lower extremity symptoms (LES) may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. Methods We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC) statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. Results In a sample of chronic LBP patients (n = 216) with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement (PCC) was estimated at 13%. "Exact" agreement between clinical and reference standard diagnoses was 32% and "clinical agreement" 51%. For six pathoanatomic categories (disc, facet joint, sacroiliac joint, hip joint, nerve root and spinal stenosis), PCC was 33% with actual agreement 56%. There was no overlap of 95% confidence intervals on any comparison. Diagnostic agreement on the six most common patho-anatomic categories produced a kappa of 0.31. Conclusion Clinical diagnoses agree with reference standards diagnoses more often than chance. Using available reference standards, most patients can have a tissue source of pain identified. PMID:15943873

[What should we know about cardiac amyloidosis? From clinical signs to treatment].

PubMed

Földeák, Dóra; Nemes, Attila; Kalapos, Anita; Domsik, Péter; Kormányos, Árpád; Krenács, László; Bagdi, Enikő; Borbényi, Zita

2017-11-01

Systemic amyloidosis is a rare disease, in which the heart involvement is rather frequent and determines survival remarkably. Regarding the disease and organ involvement, new diagnostic procedures help to establish the diagnosis and to start the adequate treatment as soon as possible. Cardiac involvement is more likely to be characterised by monoclonal immunglobulin free light chain (AL amyloidosis) type and transthyretin type. In case of AL amyloidosis, heart involvement can lead to serious consequences. Biomarker assessments for cardiac function are important to determine disease severity at the beginning and to measure response to the treatment. In case of amyloidosis, the incidence of the heart involvement grows with age. The prevalence is not known exactly, but probably there are more cases than recognised. The authors present the clinical signs and diagnostic methods, emphasizing the importance of the cardiac examination methods. Orv Hetil. 2017; 158(46): 1811-1818.

Consolidation of molecular testing in clinical virology.

PubMed

Scagnolari, Carolina; Turriziani, Ombretta; Monteleone, Katia; Pierangeli, Alessandra; Antonelli, Guido

2017-04-01

The development of quantitative methods for the detection of viral nucleic acids have significantly improved our ability to manage disease progression and to assess the efficacy of antiviral treatment. Moreover, major advances in molecular technologies during the last decade have allowed the identification of new host genetic markers associated with antiviral drug response but have also strongly revolutionized the way we see and perform virus diagnostics in the coming years. Areas covered: In this review, we describe the history and development of virology diagnostic methods, dedicating particular emphasis on the gradual evolution and recent advances toward the introduction of multiparametric platforms for the syndromic diagnosis. In parallel, we outline the consolidation of viral genome quantification practice in different clinical settings. Expert commentary: More rapid, accurate and affordable molecular technology can be predictable with particular emphasis on emerging techniques (next generation sequencing, digital PCR, point of care testing and syndromic diagnosis) to simplify viral diagnosis in the next future.

An Overview on Prenatal Screening for Chromosomal Aberrations.

PubMed

Hixson, Lucas; Goel, Srishti; Schuber, Paul; Faltas, Vanessa; Lee, Jessica; Narayakkadan, Anjali; Leung, Ho; Osborne, Jim

2015-10-01

This article is a review of current and emerging methods used for prenatal detection of chromosomal aneuploidies. Chromosomal anomalies in the developing fetus can occur in any pregnancy and lead to death prior to or shortly after birth or to costly lifelong disabilities. Early detection of fetal chromosomal aneuploidies, an atypical number of certain chromosomes, can help parents evaluate their pregnancy options. Current diagnostic methods include maternal serum sampling or nuchal translucency testing, which are minimally invasive diagnostics, but lack sensitivity and specificity. The gold standard, karyotyping, requires amniocentesis or chorionic villus sampling, which are highly invasive and can cause abortions. In addition, many of these methods have long turnaround times, which can cause anxiety in mothers. Next-generation sequencing of fetal DNA in maternal blood enables minimally invasive, sensitive, and reasonably rapid analysis of fetal chromosomal anomalies and can be of clinical utility to parents. This review covers traditional methods and next-generation sequencing techniques for diagnosing aneuploidies in terms of clinical utility, technological characteristics, and market potential. © 2015 Society for Laboratory Automation and Screening.

Optical caries diagnostics: comparison of laser spectroscopic PNC method with method of laser integral fluorescence

NASA Astrophysics Data System (ADS)

Masychev, Victor I.

2000-11-01

In this research we present the results of approbation of two methods of optical caries diagnostics: PNC-spectral diagnostics and caries detection by laser integral fluorescence. The research was conducted in a dental clinic. PNC-method analyses parameters of probing laser radiation and PNC-spectrums of stimulated secondary radiations: backscattering and endogenous fluorescence of caries-involved bacterias. He-Ne-laser ((lambda) =632,8 nm, 1-2mW) was used as a source of probing (stimulated) radiation. For registration of signals, received from intact and pathological teeth PDA-detector was applied. PNC-spectrums were processed by special algorithms, and were displayed on PC monitor. The method of laser integral fluorescence was used for comparison. In this case integral power of fluorescence of human teeth was measured. As a source of probing (stimulated) radiation diode lasers ((lambda) =655 nm, 0.1 mW and 630nm, 1mW) and He-Ne laser were applied. For registration of signals Si-photodetector was used. Integral power was shown in a digital indicator. Advantages and disadvantages of these methods are described in this research. It is disclosed that the method of laser integral power of fluorescence has the following characteristics: simplicity of construction and schema-technical decisions. However the method of PNC-spectral diagnostics are characterized by considerably more sensitivity in diagnostics of initial caries and capability to differentiate pathologies of various stages (for example, calculus/initial caries). Estimation of spectral characteristics of PNC-signals allows eliminating a number of drawbacks, which are character for detection by method of laser integral fluorescence (for instance, detection of fluorescent fillings, plagues, calculus, discolorations generally, amalgam, gold fillings as if it were caries.

Ocular toxocariasis: new diagnostic and therapeutic perspectives.

PubMed

Martínez-Pulgarín, Dayron F; Muñoz-Urbano, Marcela; Gomez-Suta, Luz D; Delgado, Olinda M; Rodriguez-Morales, Alfonso J

2015-01-01

To provide an updated insight of concepts regarding the overview, epidemiology, risk factors, clinical manifestations, diagnosis, treatment and prevention of ocular toxocariasis. Perspective of literature review. Review and synthesis of literature about toxocariasis, with interpretation and perspective. A literature search for "ocular toxocariasis" was performed using PubMed, ScienceDirect, Scopus, SciELO and LILACS databases. Mild to moderate infections are frequently reported in ocular toxocariasis which usually occurs in children and typically presents as unilateral vision impairment, blindness is common and could present invasion of the retina. There are three groups of presentation of toxocariasis (according to the physical examination): chronic endophthalmitis, posterior granuloma and peripheral granuloma. Standard diagnosis of ocular toxocariasis is based on the identification of clinical signs, supported by additional diagnostic methods. Regarding treatment, there is no commonly accepted regimen but most of the authors prefer to use steroids and anthelminthic agents, but nowadays there are no standardized parameters in terms of dosage, duration and route of administration. Surgery has been recommended in some cases. Toxocariasis is still a problem of public health, particularly in developing countries with an increasing epidemiological burden in terms of morbidity and mortality and most of the authors agree on the utmost relevance of its prevention. Clinical experience and suspicion of ophthalmologists make an important role in its diagnosis, but always with supportive diagnostic methods. Additional studies should explore new therapeutic options for toxocariasis.

Assessment of Semi-Structured Clinical Interview for Mobile Phone Addiction Disorder

PubMed Central

Alavi, Seyyed Salman; Jannatifard, Fereshteh; Mohammadi Kalhori, Soroush; Sepahbodi, Ghazal; BabaReisi, Mohammad; Sajedi, Sahar; Farshchi, Mojtaba; KhodaKarami, Rasul; Hatami Kasvaee, Vahid

2016-01-01

Objective: The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) classified mobile phone addiction disorder under “impulse control disorder not elsewhere classified”. This study surveyed the diagnostic criteria of DSM-IV-TR for the diagnosis of mobile phone addiction in correspondence with Iranian society and culture. Method: Two hundred fifty students of Tehran universities were entered into this descriptive-analytical and cross-sectional study. Quota sampling method was used. At first, semi- structured clinical interview (based on DSM-IV-TR) was performed for all the cases, and another specialist reevaluated the interviews. Data were analyzed using content validity, inter-scorer reliability (Kappa coefficient) and test-retest via SPSS18 software. Results: The content validity of the semi- structured clinical interview matched the DSM–IV-TR criteria for behavioral addiction. Moreover, their content was appropriate, and two items, including “SMS pathological use” and “High monthly cost of using the mobile phone” were added to promote its validity. Internal reliability (Kappa) and test–retest reliability were 0.55 and r = 0.4 (p<0. 01) respectively. Conclusion: The results of this study revealed that semi- structured diagnostic criteria of DSM-IV-TR are valid and reliable for diagnosing mobile phone addiction, and this instrument is an effective tool to diagnose this disorder. PMID:27437008

Neuroimaging-based biomarkers in psychiatry: clinical opportunities of a paradigm shift.

PubMed

Fu, Cynthia H Y; Costafreda, Sergi G

2013-09-01

Neuroimaging research has substantiated the functional and structural abnormalities underlying psychiatric disorders but has, thus far, failed to have a significant impact on clinical practice. Recently, neuroimaging-based diagnoses and clinical predictions derived from machine learning analysis have shown significant potential for clinical translation. This review introduces the key concepts of this approach, including how the multivariate integration of patterns of brain abnormalities is a crucial component. We survey recent findings that have potential application for diagnosis, in particular early and differential diagnoses in Alzheimer disease and schizophrenia, and the prediction of clinical response to treatment in depression. We discuss the specific clinical opportunities and the challenges for developing biomarkers for psychiatry in the absence of a diagnostic gold standard. We propose that longitudinal outcomes, such as early diagnosis and prediction of treatment response, offer definite opportunities for progress. We propose that efforts should be directed toward clinically challenging predictions in which neuroimaging may have added value, compared with the existing standard assessment. We conclude that diagnostic and prognostic biomarkers will be developed through the joint application of expert psychiatric knowledge in addition to advanced methods of analysis.

LASER BIOLOGY AND MEDICINE: Application of tunable diode lasers for a highly sensitive analysis of gaseous biomarkers in exhaled air

NASA Astrophysics Data System (ADS)

Stepanov, E. V.; Milyaev, Varerii A.

2002-11-01

The application of tunable diode lasers for a highly sensitive analysis of gaseous biomarkers in exhaled air in biomedical diagnostics is discussed. The principle of operation and the design of a laser analyser for studying the composition of exhaled air are described. The results of detection of gaseous biomarkers in exhaled air, including clinical studies, which demonstrate the diagnostic possibilities of the method, are presented.

Food allergy diagnosis and therapy: where are we now?

PubMed Central

Syed, Aleena; Kohli, Arunima; Nadeau, Kari C

2014-01-01

Food allergy is a growing worldwide epidemic that adversely effects up to 10% of the population. Causes and risk factors remain unclear and diagnostic methods are imprecise. There is currently no accepted treatment for food allergy. Therefore, there is an imminent need for greater understanding of food allergies, revised diagnostics and development of safe, effective therapies. Oral immunotherapy provides a particularly promising avenue, but is still highly experimental and not ready for clinical use. PMID:23998729

[Pathogenesis, diagnosis and therapy of Legionella infections].

PubMed

Lück, P C; Steinert, M

2006-05-01

Legionella species are ubiquitous in aquatic environments. About 50 years ago they entered the engineered (technical) environment, i.e. warm water systems with zones of stagnation. Since that time they represent a hygienic problem. After transmission to humans via aerosols legionellae might cause Legionella pneumonia (legionnaires' disease) or influenza-like respiratory infections (Pontiac fever). Epidemiological data suggest that Legionella strains might differ substantially in their virulence properties. Although the molecular basis is not understood L. pneumophila serogroup 1 especially MAb 3/1-positive strains cause the majority of infections. The main virulence feature is the ability to multiply intracellularly. After uptake into macrophages legionellae multiply in a specialized vacuole and finally lyse their host cells. Several bacterial factors like surface components, secretion systems and iron uptake systems are involved in this process. Since the clinical picture of Legionella pneumonia does not allow differentiation from pneumoniae caused by other pathogens, microbiological diagnostic methods are needed to establish the diagnosis. Cultivation of legionellae from clinical specimens, detection of antigens and DNA in patients' samples and detection of antibodies in serum samples are suitable methods. However, none of the diagnostic tests presently available offers the desired quality with respect to sensitivity and specificity. Therefore, the standard technique is to use several diagnostic tests in parallel. Advantages and disadvantages of the diagnostic procedures are discussed. Therapeutic options for Legionella infections are newer macrolides like azithromycin and chinolones (ciprofloxacin, levofloxacin and moxifloxacin).

[Molecular diagnostics of ALK-positive lung cancer].

PubMed

Tímár, József; Lotz, Gábor; Rásó, Erzsébet; Moldvay, Judit

2017-09-20

ALK translocation is the 3rd most frequent genetic aberration in lung adenocarcinoma, and several inhibitors are now clinically available in first and second line settings. Accordingly, molecular diagnostics of ALK-positive lung cancer is very important and can be done with the rational combination of several methods. All international recommendations suggest that, except for cytological samples, screening technology for ALK-positive tumors is immunohistochemistry using a validated test. It is highly recommended that in case of ALK protein positive samples gene translocation must be confirmed by fluorescent in situ hybridization (FISH). In case of cytological samples FISH technique must be used as ALK diagnostics. In equivocal cases the genetic alteration of ALK can be confirmed by alternative molecular techniques such as next generation sequencing or RNAbased PCR methods. Upon administration of ALK inhibitors, acquired resistance is frequent which is mostly due to ALK amplification and/or mutation. It is evident that the diagnostics of these secondary ALK gene alterations must be done from recurrent tumors or circulating nucleic acids.

Point of Care- A Novel Approach to Periodontal Diagnosis-A Review

PubMed Central

Nayak, Prathibha Anand; Rana, Shivendra

2017-01-01

Periodontal disease, one of the prevalent oral diseases, is characterized by gingival inflammation and periodontal tissue destruction. Diagnosing this disease is challenging to the clinicians as the disease process is discontinuous and shows periods of exacerbation and remission. Traditional diagnostic methods basically tells about the past tissue destruction so new diagnostic methods are required which is able to detect the active state of the disease, determine the future progression and also estimates the response to the therapy, thereby helping in the better clinical management of the patient. Both saliva and Gingival crevicular fluid (GCF) are believed to be reliable medium to detect the biomarkers which plays a pivotal role in measuring the disease activity. Keeping these observations in mind rapid chairside tests are developed to diagnose periodontal disease called as Point of Care (POC) diagnostics which simplifies diagnosis and helps in improving the prognosis. This review article highlights about the biomarkers used in the diagnosis and throws light on the various available point of care diagnostic devices. PMID:28969294

[Diagnostic imaging of breast cancer : An update].

PubMed

Funke, M

2016-10-01

Advances in imaging of the female breast have substantially influenced the diagnosis and probably also the therapy and prognosis of breast cancer in the past few years. This article gives an overview of the most important imaging modalities in the diagnosis of breast cancer. Digital mammography is considered to be the gold standard for the early detection of breast cancer. Digital breast tomosynthesis can increase the diagnostic accuracy of mammography and is used for the assessment of equivocal or suspicious mammography findings. Other modalities, such as ultrasound and contrast-enhanced magnetic resonance imaging (MRI) play an important role in the diagnostics, staging and follow-up of breast cancer. Percutaneous needle biopsy is a rapid and minimally invasive method for the histological verification of breast cancer. New breast imaging modalities, such as contrast-enhanced spectral mammography, diffusion-weighted MRI and MR spectroscopy can possibly further improve breast cancer diagnostics; however, further studies are necessary to prove the advantages of these methods so that they cannot yet be recommended for routine clinical use.

Clinical and diagnostic utility of saliva as a non-invasive diagnostic fluid:
a systematic review

PubMed Central

Nunes, Lazaro Alessandro Soares; Mussavira, Sayeeda

2015-01-01

This systematic review presents the latest trends in salivary research and its applications in health and disease. Among the large number of analytes present in saliva, many are affected by diverse physiological and pathological conditions. Further, the non-invasive, easy and cost-effective collection methods prompt an interest in evaluating its diagnostic or prognostic utility. Accumulating data over the past two decades indicates towards the possible utility of saliva to monitor overall health, diagnose and treat various oral or systemic disorders and drug monitoring. Advances in saliva based systems biology has also contributed towards identification of several biomarkers, development of diverse salivary diagnostic kits and other sensitive analytical techniques. However, its utilization should be carefully evaluated in relation to standardization of pre-analytical and analytical variables, such as collection and storage methods, analyte circadian variation, sample recovery, prevention of sample contamination and analytical procedures. In spite of all these challenges, there is an escalating evolution of knowledge with the use of this biological matrix. PMID:26110030

Molecular Diagnostics of Ageing and Tackling Age-related Disease.

PubMed

Timmons, James A

2017-01-01

As average life expectancy increases there is a greater focus on health-span and, in particular, how to treat or prevent chronic age-associated diseases. Therapies which were able to control 'biological age' with the aim of postponing chronic and costly diseases of old age require an entirely new approach to drug development. Molecular technologies and machine-learning methods have already yielded diagnostics that help guide cancer treatment and cardiovascular procedures. Discovery of valid and clinically informative diagnostics of human biological age (combined with disease-specific biomarkers) has the potential to alter current drug-discovery strategies, aid clinical trial recruitment and maximize healthy ageing. I will review some basic principles that govern the development of 'ageing' diagnostics, how such assays could be used during the drug-discovery or development process. Important logistical and statistical considerations are illustrated by reviewing recent biomarker activity in the field of Alzheimer's disease, as dementia represents the most pressing of priorities for the pharmaceutical industry, as well as the chronic disease in humans most associated with age. Copyright © 2016 Elsevier Ltd. All rights reserved.

Understanding the reliability of diagnostic variables in a Chinese Medicine examination.

PubMed

O'Brien, Kylie A; Abbas, Estelle; Zhang, Jiansheng; Guo, Zhi-Xin; Luo, Ruizhi; Bensoussan, Alan; Komesaroff, Paul A

2009-07-01

The question of the objectivity of the clinical examination has been raised in relation to Western and non-Western medical systems. Western practitioners are often skeptical about Traditional Chinese Medicine (TCM), on the basis that its diagnostic variables and subcategories of disease appear subjective and not repeatable. We conducted a study investigating the reproducibility of individual diagnostic observations within three of the four diagnostic methods used in a TCM examination: inspection, palpation, and auscultation. Three TCM practitioners participated in the study, and examined 45 adults who had mild-to-moderate hypercholesterolemia but were otherwise healthy. Results indicated that while there are certain features of the TCM system that are highly objective and repeatable, such as detection of the presence of shen, character of breath sounds, and pulse speed, there are other features that are subjective and unreliable, such as color under the eyes and tongue body color. This poses a challenge for TCM practitioners to improve their clinical practice and demonstrates to Western medical practitioners that TCM does in part rest on a rigorous and objective empirical basis.

Benefit-risk Evaluation for Diagnostics: A Framework (BED-FRAME).

PubMed

Evans, Scott R; Pennello, Gene; Pantoja-Galicia, Norberto; Jiang, Hongyu; Hujer, Andrea M; Hujer, Kristine M; Manca, Claudia; Hill, Carol; Jacobs, Michael R; Chen, Liang; Patel, Robin; Kreiswirth, Barry N; Bonomo, Robert A

2016-09-15

The medical community needs systematic and pragmatic approaches for evaluating the benefit-risk trade-offs of diagnostics that assist in medical decision making. Benefit-Risk Evaluation of Diagnostics: A Framework (BED-FRAME) is a strategy for pragmatic evaluation of diagnostics designed to supplement traditional approaches. BED-FRAME evaluates diagnostic yield and addresses 2 key issues: (1) that diagnostic yield depends on prevalence, and (2) that different diagnostic errors carry different clinical consequences. As such, evaluating and comparing diagnostics depends on prevalence and the relative importance of potential errors. BED-FRAME provides a tool for communicating the expected clinical impact of diagnostic application and the expected trade-offs of diagnostic alternatives. BED-FRAME is a useful fundamental supplement to the standard analysis of diagnostic studies that will aid in clinical decision making. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Neuropsychological Criteria for Mild Cognitive Impairment Improves Diagnostic Precision, Biomarker Associations, and Progression Rates

PubMed Central

Bondi, Mark W.; Edmonds, Emily C.; Jak, Amy J.; Clark, Lindsay R.; Delano-Wood, Lisa; McDonald, Carrie R.; Nation, Daniel A.; Libon, David J.; Au, Rhoda; Galasko, Douglas; Salmon, David P.

2014-01-01

We compared two methods of diagnosing mild cognitive impairment (MCI): conventional Petersen/Winblad criteria as operationalized by the Alzheimer’s Disease Neuroimaging Initiative (ADNI) and an actuarial neuropsychological method put forward by Jak and Bondi designed to balance sensitivity and reliability. 1,150 ADNI participants were diagnosed at baseline as cognitively normal (CN) or MCI via ADNI criteria (MCI: n = 846; CN: n = 304) or Jak/Bondi criteria (MCI: n = 401; CN: n = 749), and the two MCI samples were submitted to cluster and discriminant function analyses. Resulting cluster groups were then compared and further examined for APOE allelic frequencies, cerebrospinal fluid (CSF) Alzheimer’s disease (AD) biomarker levels, and clinical outcomes. Results revealed that both criteria produced a mildly impaired Amnestic subtype and a more severely impaired Dysexecutive/Mixed subtype. The neuropsychological Jak/Bondi criteria uniquely yielded a third Impaired Language subtype, whereas conventional Petersen/Winblad ADNI criteria produced a third subtype comprising nearly one-third of the sample that performed within normal limits across the cognitive measures, suggesting this method’s susceptibility to false positive diagnoses. MCI participants diagnosed via neuropsychological criteria yielded dissociable cognitive phenotypes, significant CSF AD biomarker associations, more stable diagnoses, and identified greater percentages of participants who progressed to dementia than conventional MCI diagnostic criteria. Importantly, the actuarial neuropsychological method did not produce a subtype that performed within normal limits on the cognitive testing, unlike the conventional diagnostic method. Findings support the need for refinement of MCI diagnoses to incorporate more comprehensive neuropsychological methods, with resulting gains in empirical characterization of specific cognitive phenotypes, biomarker associations, stability of diagnoses, and prediction of progression. Refinement of MCI diagnostic methods may also yield gains in biomarker and clinical trial study findings because of improvements in sample compositions of ‘true positive’ cases and removal of ‘false positive’ cases. PMID:24844687

A Methodology for Anatomic Ultrasound Image Diagnostic Quality Assessment.

PubMed

Hemmsen, Martin Christian; Lange, Theis; Brandt, Andreas Hjelm; Nielsen, Michael Bachmann; Jensen, Jorgen Arendt

2017-01-01

This paper discusses the methods for the assessment of ultrasound image quality based on our experiences with evaluating new methods for anatomic imaging. It presents a methodology to ensure a fair assessment between competing imaging methods using clinically relevant evaluations. The methodology is valuable in the continuing process of method optimization and guided development of new imaging methods. It includes a three phased study plan covering from initial prototype development to clinical assessment. Recommendations to the clinical assessment protocol, software, and statistical analysis are presented. Earlier uses of the methodology has shown that it ensures validity of the assessment, as it separates the influences between developer, investigator, and assessor once a research protocol has been established. This separation reduces confounding influences on the result from the developer to properly reveal the clinical value. This paper exemplifies the methodology using recent studies of synthetic aperture sequential beamforming tissue harmonic imaging.

Examination of Neurological Subtle Signs in ADHD as a Clinical Tool for the Diagnosis and Their Relationship to Spatial Working Memory

ERIC Educational Resources Information Center

Ferrin, Maite; Vance, Alasdair

2012-01-01

Background: Neurological subtle signs (NSS) are minor neurological abnormalities that have been shown to be increased in a number of neurodevelopmental conditions. For attention deficit/hyperactivity disorder (ADHD), it remains unclear whether NSS may aid the clinical diagnostic process. Methods: This study explored the association of total and…

A Practical Approach to Tumor Heterogeneity in Clinical Research and Diagnostics.

PubMed

Stanta, Giorgio; Bonin, Serena

2018-01-01

This Pathobiology issue tries to better define the complex phenomenon of intratumor heterogeneity (ITH), mostly from a practical point of view. This topic has been chosen because ITH is a central issue in tumor development and has to be investigated directly in patient tissue and immediately applied in the treatment of the presenting patient. Different types of ITH should be considered: clonal genetic and epigenetic evolution, morphological heterogeneity, and tumor sampling, heterogeneity resulting from microenvironmental autocrine and paracrine interaction, and stochastic plasticity related to different functional cell efficiencies. For a higher level of reproducibility in clinical research and diagnostics, it is necessary to establish standardized analytical methods, including microdissection. In situ techniques can be pivotal to explore tumor microenvironment and can be improved with associated digital analysis. Liquid biopsies for plasma DNA analysis are at present the best method to study recurrent tumors with treatment adaptation, and widespread clinical use could be beneficial. The different types of tumor genomic instabilities could have pragmatic applications to rank ITH for clinical applications: treatment approaches differ in patients with a high nucleotide mutation rate and patients with high copy number alterations. © 2017 S. Karger AG, Basel.

MO-F-204-04: Preparing for Parts 2 & 3 of the ABR Nuclear Medicine Physics Exam

DOE Office of Scientific and Technical Information (OSTI.GOV)

MacDougall, R.

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance of allmore » aspects of clinical medical physics. All parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those unique aspects of the nuclear exam, and how preparing for a second specialty differs from the first. Medical physicists who recently completed each ABR exam portion will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations How to prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations How to prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.« less

WE-D-213-04: Preparing for Parts 2 & 3 of the ABR Nuclear Medicine Physics Exam

DOE Office of Scientific and Technical Information (OSTI.GOV)

MacDougall, R.

Adequate, efficient preparation for the ABR Diagnostic and Nuclear Medical Physics exams is key to successfully obtain ABR professional certification. Each part of the ABR exam presents its own challenges: Part I: Determine the scope of basic medical physics study material, efficiently review this material, and solve related written questions/problems. Part II: Understand imaging principles, modalities, and systems, including image acquisition, processing, and display. Understand the relationship between imaging techniques, image quality, patient dose and safety, and solve related written questions/problems. Part III: Gain crucial, practical, clinical medical physics experience. Effectively communicate and explain the practice, performance, and significance ofmore » all aspects of clinical medical physics. All three parts of the ABR exam require specific skill sets and preparation: mastery of basic physics and imaging principles; written problem solving often involving rapid calculation; responding clearly and succinctly to oral questions about the practice, methods, and significance of clinical medical physics. This symposium focuses on the preparation and skill sets necessary for each part of the ABR exam. Although there is some overlap, the nuclear exam covers a different body of knowledge than the diagnostic exam. A separate speaker will address those aspects that are unique to the nuclear exam. Medical physicists who have recently completed each of part of the ABR exam will share their experiences, insights, and preparation methods to help attendees best prepare for the challenges of each part of the ABR exam. In accordance with ABR exam security policy, no recalls or exam questions will be discussed. Learning Objectives: How to prepare for Part 1 of the ABR exam by determining the scope of basic medical physics study material and related problem solving/calculations How to Prepare for Part 2 of the ABR exam by understanding diagnostic and/or nuclear imaging physics, systems, dosimetry, safety and related problem solving/calculations How to Prepare for Part 3 of the ABR exam by effectively communicating the practice, methods, and significance of clinical diagnostic and/or nuclear medical physics.« less

Evaluation of recombinase polymerase amplification for detection of begomoviruses by plant diagnostic clinics.

PubMed

Londoño, Maria A; Harmon, Carrie L; Polston, Jane E

2016-03-22

Plant viruses in the genus Begomovirus, family Geminiviridae often cause substantial crop losses. These viruses have been emerging in many locations throughout the tropics and subtropics. Like many plant viruses, they are often not recognized by plant diagnostic clinics due in large part to the lack of rapid and cost effective assays. An isothermal amplification assay, Recombinase polymerase amplification (RPA), was evaluated for its ability to detect three begomoviruses and for its suitability for use in plant diagnostic clinics. Methods for DNA extraction and separation of amplicons from proteins used in the assay were modified and compared to RPA manufacturer's protocols. The modified RPA assays were compared to PCR assays for sensitivity, use in downstream applications, cost, and speed. Recombinase polymerase amplification (RPA) assays for the detection of Bean golden yellow mosaic virus, Tomato mottle virus and Tomato yellow leaf curl virus (TYLCV) were specific, only amplifying the target viruses in three different host species. RPA was able to detect the target virus when the template was in a crude extract generated using a simple inexpensive extraction method, while PCR was not. Separation of RPA-generated amplicons from DNA-binding proteins could be accomplished by several methods, all of which were faster and less expensive than that recommended by the manufacturer. Use of these modifications resulted in an RPA assay that was faster than PCR but with a similar reagent cost. This modified RPA was the more cost effective assay when labor is added to the cost since RPA can be performed much faster than PCR. RPA had a sensitivity approximate to that of ELISA when crude extract was used as template. RPA-generated amplicons could be used in downstream applications (TA cloning, digestion with a restriction endonuclease, direct sequencing) similar to PCR but unlike some other isothermal reactions. RPA could prove useful for the cost effective detection of plant viruses by plant diagnostic clinics. It can be performed in one hour or less with a reagent cost similar to that of PCR but with a lower labor cost, and with an acceptable level of sensitivity and specificity.

Remote skin tissue diagnostics in vivo by fiber optic evanescent wave Fourier transform infrared (FEW-FTIR) spectroscopy

NASA Astrophysics Data System (ADS)

Afanasyeva, Natalia I.; Kolyakov, Sergei F.; Butvina, Leonid N.

1998-04-01

The new method of fiber-optical evanescent wave Fourier transform IR (FEW-FTIR) spectroscopy has been applied to the diagnostics of normal tissue, as well as precancerous and cancerous conditions. The FEW-FTIR technique is nondestructive and sensitive to changes of vibrational spectra in the IR region, without heating and damaging human and animal skin tissue. Therefore this method and technique is an ideal diagnostic tool for tumor and cancer characterization at an early stage of development on a molecular level. The application of fiber optic technology in the middle IR region is relatively inexpensive and can be adapted easily to any commercially available tabletop FTIR spectrometers. This method of diagnostics is fast, remote, and can be applied to many fields Noninvasive medical diagnostics of skin cancer and other skin diseases in vivo, ex vivo, and in vitro allow for the development convenient, remote clinical applications in dermatology and related fields. The spectral variations from normal to pathological skin tissue and environmental influence on skin have been measured and assigned in the regions of 850-4000 cm-1. The lipid structure changes are discussed. We are able to develop the spectral histopathology as a fast and informative tool of analysis.

Developing system for delivery of optical radiation in medicobiological researches

NASA Astrophysics Data System (ADS)

Loschenov, Victor B.; Taraz, Majid

2004-06-01

Methods of optical diagnostics and methods of photodynamic therapy are actively used in medico-biological researches. The system for delivery of optical radiation is one of the key methods in these researches. Usually these systems use flexible optical fibers with diameters from 200 to 1000 micron. Two types of systems for delivery are subdivided, first for diagnostic researches, second for therapeutic procedures. Existing diagnostic catheters, which have most widely applied in medicine, have bifurcated with diameter of the tip equal 1.8 mm. These devices, which are called fiber-optical catheters, satisfy the majority endoscopes researches. However, till now the problem of optical-diagnostics inside tissue is not soled. Especially it is important at diagnostics of a mammary gland, livers, thyroid glands tumor, tumor of a brain and some other studies connected with punctures. In these cases, it is necessary that diameter of fiber-optical catheters be less than one millimeter. This work is devoted to the development of these catheters. Also in clinical procedures such as photodynamic therapy (PDT) and interstitial laser photocoagulation (ILP), cylindrical light diffusing tips are rapidly becoming a popular device for the administration of the desired light dose for the illumination of hollow organs, such as bronchus, trachea and oesophagus. This work is devoted to the development of these catheters.

Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials.

PubMed

Van Heertum, Ronald L; Scarimbolo, Robert; Ford, Robert; Berdougo, Eli; O'Neal, Michael

2015-01-01

In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes.

Assessment of the Validity of the Research Diagnostic Criteria for Temporomandibular Disorders: Overview and Methodology

PubMed Central

Schiffman, Eric L.; Truelove, Edmond L.; Ohrbach, Richard; Anderson, Gary C.; John, Mike T.; List, Thomas; Look, John O.

2011-01-01

AIMS The purpose of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project was to assess the diagnostic validity of this examination protocol. An overview is presented, including Axis I and II methodology and descriptive statistics for the study participant sample. This paper details the development of reliable methods to establish the reference standards for assessing criterion validity of the Axis I RDC/TMD diagnoses. Validity testing for the Axis II biobehavioral instruments was based on previously validated reference standards. METHODS The Axis I reference standards were based on the consensus of 2 criterion examiners independently performing a comprehensive history, clinical examination, and evaluation of imaging. Intersite reliability was assessed annually for criterion examiners and radiologists. Criterion exam reliability was also assessed within study sites. RESULTS Study participant demographics were comparable to those of participants in previous studies using the RDC/TMD. Diagnostic agreement of the criterion examiners with each other and with the consensus-based reference standards was excellent with all kappas ≥ 0.81, except for osteoarthrosis (moderate agreement, k = 0.53). Intrasite criterion exam agreement with reference standards was excellent (k ≥ 0.95). Intersite reliability of the radiologists for detecting computed tomography-disclosed osteoarthrosis and magnetic resonance imaging-disclosed disc displacement was good to excellent (k = 0.71 and 0.84, respectively). CONCLUSION The Validation Project study population was appropriate for assessing the reliability and validity of the RDC/TMD Axis I and II. The reference standards used to assess the validity of Axis I TMD were based on reliable and clinically credible methods. PMID:20213028

Diagnosis of Bubonic Plague by PCR in Madagascar under Field Conditions

PubMed Central

Rahalison, L.; Vololonirina, E.; Ratsitorahina, M.; Chanteau, S.

2000-01-01

The diagnostic value of a PCR assay that amplifies a 501-bp fragment of the Yersinia pestis caf1 gene has been determined in a reference laboratory with 218 bubo aspirates collected from patients with clinically suspected plague managed in a regional hospital in Madagascar. The culture of Y. pestis and the detection of the F1 antigen (Ag) by enzyme-linked immunosorbent assay (ELISA) were used as reference diagnostic methods. The sensitivity of PCR was 89% (57 of 64) for the Y. pestis-positive patients, and 80.7% (63 of 78) for the F1 Ag-positive patients. The specificity of PCR for the culture-, F1 Ag-, and antibody-negative patients (n = 105) was 100%. Because in Madagascar most patients with plague are managed and their clinical samples are collected in remote villages, the usefulness of PCR was evaluated for routine diagnostic use in the operational conditions of the control program. The sensitivity of PCR was 50% (25 of 50) relative to the results of culture and 35.2% (19 of 54) relative to the results of the F1 Ag immunocapture ELISA. The specificity of PCR under these conditions was 96%. In conclusion, the PCR method was found to be very specific but not as sensitive as culture or the F1 Ag detection method. The limitation in sensitivity may have been due to suboptimal field conditions and the small volumes of samples used for DNA extraction. This technique is not recommended as a routine diagnostic test for plague in Madagascar. PMID:10618097

Accuracy of dementia diagnosis: a direct comparison between radiologists and a computerized method.

PubMed

Klöppel, Stefan; Stonnington, Cynthia M; Barnes, Josephine; Chen, Frederick; Chu, Carlton; Good, Catriona D; Mader, Irina; Mitchell, L Anne; Patel, Ameet C; Roberts, Catherine C; Fox, Nick C; Jack, Clifford R; Ashburner, John; Frackowiak, Richard S J

2008-11-01

There has been recent interest in the application of machine learning techniques to neuroimaging-based diagnosis. These methods promise fully automated, standard PC-based clinical decisions, unbiased by variable radiological expertise. We recently used support vector machines (SVMs) to separate sporadic Alzheimer's disease from normal ageing and from fronto-temporal lobar degeneration (FTLD). In this study, we compare the results to those obtained by radiologists. A binary diagnostic classification was made by six radiologists with different levels of experience on the same scans and information that had been previously analysed with SVM. SVMs correctly classified 95% (sensitivity/specificity: 95/95) of sporadic Alzheimer's disease and controls into their respective groups. Radiologists correctly classified 65-95% (median 89%; sensitivity/specificity: 88/90) of scans. SVM correctly classified another set of sporadic Alzheimer's disease in 93% (sensitivity/specificity: 100/86) of cases, whereas radiologists ranged between 80% and 90% (median 83%; sensitivity/specificity: 80/85). SVMs were better at separating patients with sporadic Alzheimer's disease from those with FTLD (SVM 89%; sensitivity/specificity: 83/95; compared to radiological range from 63% to 83%; median 71%; sensitivity/specificity: 64/76). Radiologists were always accurate when they reported a high degree of diagnostic confidence. The results show that well-trained neuroradiologists classify typical Alzheimer's disease-associated scans comparable to SVMs. However, SVMs require no expert knowledge and trained SVMs can readily be exchanged between centres for use in diagnostic classification. These results are encouraging and indicate a role for computerized diagnostic methods in clinical practice.

Accuracy of dementia diagnosis—a direct comparison between radiologists and a computerized method

PubMed Central

Stonnington, Cynthia M.; Barnes, Josephine; Chen, Frederick; Chu, Carlton; Good, Catriona D.; Mader, Irina; Mitchell, L. Anne; Patel, Ameet C.; Roberts, Catherine C.; Fox, Nick C.; Jack, Clifford R.; Ashburner, John; Frackowiak, Richard S. J.

2008-01-01

There has been recent interest in the application of machine learning techniques to neuroimaging-based diagnosis. These methods promise fully automated, standard PC-based clinical decisions, unbiased by variable radiological expertise. We recently used support vector machines (SVMs) to separate sporadic Alzheimer's disease from normal ageing and from fronto-temporal lobar degeneration (FTLD). In this study, we compare the results to those obtained by radiologists. A binary diagnostic classification was made by six radiologists with different levels of experience on the same scans and information that had been previously analysed with SVM. SVMs correctly classified 95% (sensitivity/specificity: 95/95) of sporadic Alzheimer's disease and controls into their respective groups. Radiologists correctly classified 65–95% (median 89%; sensitivity/specificity: 88/90) of scans. SVM correctly classified another set of sporadic Alzheimer's disease in 93% (sensitivity/specificity: 100/86) of cases, whereas radiologists ranged between 80% and 90% (median 83%; sensitivity/specificity: 80/85). SVMs were better at separating patients with sporadic Alzheimer's disease from those with FTLD (SVM 89%; sensitivity/specificity: 83/95; compared to radiological range from 63% to 83%; median 71%; sensitivity/specificity: 64/76). Radiologists were always accurate when they reported a high degree of diagnostic confidence. The results show that well-trained neuroradiologists classify typical Alzheimer's disease-associated scans comparable to SVMs. However, SVMs require no expert knowledge and trained SVMs can readily be exchanged between centres for use in diagnostic classification. These results are encouraging and indicate a role for computerized diagnostic methods in clinical practice. PMID:18835868

Decision curve analysis: a novel method for evaluating prediction models.

PubMed

Vickers, Andrew J; Elkin, Elena B

2006-01-01

Diagnostic and prognostic models are typically evaluated with measures of accuracy that do not address clinical consequences. Decision-analytic techniques allow assessment of clinical outcomes but often require collection of additional information and may be cumbersome to apply to models that yield a continuous result. The authors sought a method for evaluating and comparing prediction models that incorporates clinical consequences,requires only the data set on which the models are tested,and can be applied to models that have either continuous or dichotomous results. The authors describe decision curve analysis, a simple, novel method of evaluating predictive models. They start by assuming that the threshold probability of a disease or event at which a patient would opt for treatment is informative of how the patient weighs the relative harms of a false-positive and a false-negative prediction. This theoretical relationship is then used to derive the net benefit of the model across different threshold probabilities. Plotting net benefit against threshold probability yields the "decision curve." The authors apply the method to models for the prediction of seminal vesicle invasion in prostate cancer patients. Decision curve analysis identified the range of threshold probabilities in which a model was of value, the magnitude of benefit, and which of several models was optimal. Decision curve analysis is a suitable method for evaluating alternative diagnostic and prognostic strategies that has advantages over other commonly used measures and techniques.

Rapid and accurate detection of KRAS mutations in colorectal cancers using the isothermal-based optical sensor for companion diagnostics

PubMed Central

Koo, Bonhan; Lee, Tae Yoon; Lee, Jeong Hoon; Shin, Yong; Lim, Seok-Byung

2017-01-01

Although KRAS mutational status testing is becoming a companion diagnostic tool for managing patients with colorectal cancer (CRC), there are still several difficulties when analyzing KRAS mutations using the existing assays, particularly with regard to low sensitivity, its time-consuming, and the need for large instruments. We developed a rapid, sensitive, and specific mutation detection assay based on the bio-photonic sensor termed ISAD (isothermal solid-phase amplification/detection), and used it to analyze KRAS gene mutations in human clinical samples. To validate the ISAD-KRAS assay for use in clinical diagnostics, we examined for hotspot KRAS mutations (codon 12 and codon 13) in 70 CRC specimens using PCR and direct sequencing methods. In a serial dilution study, ISAD-KRAS could detect mutations in a sample containing only 1% of the mutant allele in a mixture of wild-type DNA, whereas both PCR and direct sequencing methods could detect mutations in a sample containing approximately 30% of mutant cells. The results of the ISAD-KRAS assay from 70 clinical samples matched those from PCR and direct sequencing, except in 5 cases, wherein ISAD-KRAS could detect mutations that were not detected by PCR and direct sequencing. We also found that the sensitivity and specificity of ISAD-KRAS were 100% within 30 min. The ISAD-KRAS assay provides a rapid, highly sensitive, and label-free method for KRAS mutation testing, and can serve as a robust and near patient testing approach for the rapid detection of patients most likely to respond to anti-EGFR drugs. PMID:29137388

Diagnostic Yield of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

PubMed Central

2011-01-01

Background: New transbronchial needle aspiration (TBNA) technologies have been developed, but their clinical effectiveness and determinants of diagnostic yield have not been quantified. Prospective data are needed to determine risk-adjusted diagnostic yield. Methods: We prospectively enrolled patients undergoing TBNA of mediastinal lymph nodes in the American College of Chest Physicians Quality Improvement Registry, Evaluation, and Education (AQuIRE) multicenter database and recorded clinical, procedural, and provider information. All clinical decisions, including type of TBNA used (conventional vs endobronchial ultrasound-guided), were made by the attending bronchoscopist. The primary outcome was obtaining a specific diagnosis. Results: We enrolled 891 patients at six hospitals. Most procedures (95%) were performed with ultrasound guidance. A specific diagnosis was made in 447 cases. Unadjusted diagnostic yields were 37% to 54% for different hospitals, with significant between-hospital heterogeneity (P = .0001). Diagnostic yield was associated with annual hospital TBNA volume (OR, 1.003; 95% CI, 1.000-1.006; P = .037), smoking (OR, 1.55; 95% CI, 1.02-2.34; P = .042), biopsy of more than two sites (OR, 0.57; 95% CI, 0.38-0.85; P = .015), lymph node size (reference > 1-2 cm, ≤ 1 cm: OR, 0.51; 95% CI, 0.34-0.77; P = .003; > 2-3 cm: OR, 2.49; 95% CI, 1.61-3.85; P < .001; and > 3 cm: OR, 3.61; 95% CI, 2.17-6.00; P < .001), and positive PET scan (OR, 3.12; 95% CI, 1.39-7.01; P = .018). Biopsy was performed on more and smaller nodes at high-volume hospitals (P < .0001). Conclusions: To our knowledge, this is the first bronchoscopy study of risk-adjusted diagnostic yields on a hospital-level basis. High-volume hospitals were associated with high diagnostic yields. This study also demonstrates the value of procedural registries as a quality improvement tool. A larger number and variety of participating hospitals is needed to verify these results and to further investigate other determinants of diagnostic yield. PMID:21659432

The STARD Statement for Reporting Diagnostic Accuracy Studies: Application to the History and Physical Examination

PubMed Central

Rennie, Drummond; Bossuyt, Patrick M. M.

2008-01-01

Summary Objective The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Setting Nonsystematic review of the STARD statement. Interventions Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. Measurements and Main Results The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. Conclusions The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient’s history and physical examination. PMID:18347878

Is there a role for antibody testing in the diagnosis of invasive candidiasis?

PubMed

Quindós, Guillermo; Moragues, María Dolores; Pontón, José

2004-03-01

During the last decades, the use of antibody tests for the diagnosis of invasive mycoses has declined as a consequence of the general belief that they are insensitive and non-specific. However, there is a clear evidence that antibodies can be detected in highly immunodeficient patients (such as bone marrow transplant recipients), and that those antibodies are useful for the diagnosis. Antibody tests are currently in use as diagnostic tools for some primary mycoses, such as the endemic mycoses, aspergilloma, allergic bronchopulmonary aspergilosis and sporothrichosis. For invasive candidiasis, diagnostic methods must differentiate Candida colonization of mucous membranes or superficial infection from tissue invasion by this microorganism. Substantial progress has been made in diagnosis of invasive candidiasis with the development of a variety of methods for the detection of antibodies and antigens. However, no single test has found widespread clinical use and there is a consensus that diagnosis based on a single specimen lacks sensitivity. It is necessary to test sequential samples taken while the patient is at greatest risk for developing invasive candidiasis to optimize the diagnosis. Results obtained from a panel of diagnostic tests in association with clinical aspects will likely be the most useful strategy for early diagnosis and therapy.

Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs.

PubMed

Clarke, Diana E; Wilcox, Holly C; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H; Newcomer, Alison; McKitty, Mellisha V; Regier, Darrel A; Narrow, William E

2014-06-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients' experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. Copyright © 2013, American Psychiatric Association. All rights reserved.

Molecular diagnostics for human leptospirosis.

PubMed

Waggoner, Jesse J; Pinsky, Benjamin A

2016-10-01

The definitive diagnosis of leptospirosis, which results from infection with spirochetes of the genus Leptospira, currently relies on the use of culture, serological testing (microscopic agglutination testing), and molecular detection. The purpose of this review is to describe new molecular diagnostics for Leptospira and discuss advancements in the use of available methods. Efforts have been focused on improving the clinical sensitivity of Leptospira detection using molecular methods. In this review, we describe a reoptimized pathogenic species-specific real-time PCR (targeting lipL32) that has demonstrated improved sensitivity, findings by two groups that real-time reverse-transcription PCR assays targeting the 16S rrs gene can improve detection, and two new loop-mediated amplification techniques. Quantitation of leptospiremia, detection in different specimen types, and the complementary roles played by molecular detection and microscopic agglutination testing will be discussed. Finally, a protocol for Leptospira strain subtyping using variable number tandem repeat targets and high-resolution melting will be described. Molecular diagnostics have an established role for the diagnosis of leptospirosis and provide an actionable diagnosis in the acute setting. The use of real-time reverse-transcription PCR for testing serum/plasma and cerebrospinal fluid, when available, may improve the detection of Leptospira without decreasing clinical specificity.

Proteome-based bacterial identification using matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS): A revolutionary shift in clinical diagnostic microbiology.

PubMed

Nomura, Fumio

2015-06-01

Rapid and accurate identification of microorganisms, a prerequisite for appropriate patient care and infection control, is a critical function of any clinical microbiology laboratory. Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) is a quick and reliable method for identification of microorganisms, including bacteria, yeast, molds, and mycobacteria. Indeed, there has been a revolutionary shift in clinical diagnostic microbiology. In the present review, the state of the art and advantages of MALDI-TOF MS-based bacterial identification are described. The potential of this innovative technology for use in strain typing and detection of antibiotic resistance is also discussed. This article is part of a Special Issue entitled: Medical Proteomics. Copyright © 2014 Elsevier B.V. All rights reserved.

Personalized medicine in psychiatry.

PubMed

Wium-Andersen, Ida Kim; Vinberg, Maj; Kessing, Lars Vedel; McIntyre, Roger S

2017-01-01

Personalized medicine is a model in which a patient's unique clinical, genetic, and environmental characteristics are the basis for treatment and prevention. Aim, method, and results: This review aims to describe the current tools, phenomenological features, clinical risk factors, and biomarkers used to provide personalized medicine. Furthermore, this study describes the target areas in which they can be applied including diagnostics, treatment selection and response, assessment of risk of side-effects, and prevention. Personalized medicine in psychiatry is challenged by the current taxonomy, where the diagnostic categories are broad and great biological heterogeneity exists within each category. There is, thus, a gap between the current advanced research prospects and clinical practice, and the current taxonomy is, thus, a poor basis for biological research. The discussion proposes possible solutions to narrow this gap and to move psychiatric research forward towards personalized medicine.

Socio-economic, gender and health services factors affecting diagnostic delay for tuberculosis patients in urban Zambia.

PubMed

Needham, D M; Foster, S D; Tomlinson, G; Godfrey-Faussett, P

2001-04-01

In-depth interviews regarding health seeking behaviour were conducted with 202 adults registered with pulmonary tuberculosis at the centralized Chest Clinic in Lusaka, Zambia. The median (mean) diagnostic delay was 8.6 (9) weeks, and was significantly associated with the following factors: female sex, lower education, more than six instances of health-seeking encounters, outpatient diagnosis of tuberculosis, and visiting a private doctor or traditional healer. More effective tuberculosis control interventions require novel methods of accessing women and less educated people. Decentralization of public tuberculosis care and improved integration with private sector health providers may also reduce diagnostic delay.

Coupling gene-based and classic veterinary diagnostics improves interpretation of health and immune function in the Agassiz’s desert tortoise (Gopherus agassizii)

USGS Publications Warehouse

Drake, Karla K.; Bowen, Lizabeth; Lewison, Rebecca L.; Esque, Todd C.; Nussear, Kenneth E.; Braun, Josephine; Waters, Shannon C.; Miles, A. Keith

2017-01-01

The analysis of blood constituents is a widely used tool to aid in monitoring of animal health and disease. However, classic blood diagnostics (i.e. hematologic and plasma biochemical values) often do not provide sufficient information to determine the state of an animal’s health. Field studies on wild tortoises and other reptiles have had limited success in drawing significant inferences between blood diagnostics and physiological and immunological condition. However, recent research using gene transcription profiling in the threatened Mojave desert tortoise (Gopherus agassizii) has proved useful in identifying immune or physiologic responses and overall health. To improve our understanding of health and immune function in tortoises, we evaluated both standard blood diagnostic (body condition, hematologic, plasma biochemistry values, trace elements, plasma proteins, vitamin A levels) and gene transcription profiles in 21 adult tortoises (11 clinically abnormal; 10 clinically normal) from Clark County, NV, USA. Necropsy and histology evaluations from clinically abnormal tortoises revealed multiple physiological complications, with moderate to severe rhinitis or pneumonia being the primary cause of morbidity in all but one of the examined animals. Clinically abnormal tortoises had increased transcription for four genes (SOD, MyD88, CL and Lep), increased lymphocyte production, biochemical enzymes and organics, trace elements of copper, and decreased numbers of leukocytes. We found significant positive correlations between increased transcription for SOD and increased trace elements for copper, as well as genes MyD88 and Lep with increased inflammation and microbial insults. Improved methods for health assessments are an important element of monitoring tortoise population recovery and can support the development of more robust diagnostic measures for ill animals, or individuals directly impacted by disturbance.

Effect of Patient Navigation on Time to Diagnostic Resolution among Patients with Colorectal Cancer Related Abnormalities

PubMed Central

Lee, Ji-Hyun; Fulp, William; Wells, Kristen J.; Meade, Cathy D.; Calcano, Ercilia; Roetzheim, Richard

2013-01-01

Objectives The objective of this study is to evaluate whether a patient navigation (PN) program is effective in reducing delay in diagnostic resolution among medically underserved patients with colorectal cancer (CRC) related abnormalities in Tampa Bay, Florida. Methods This study involved 10 primary care clinics randomized either to receive navigation or serve as controls (5 clinics per arm). Each clinic identified all subjects with colorectal-related abnormalities in the year prior to the clinic beginning participation in the Moffitt Patient Navigation Research Program. Patients with CRC related abnormalities were navigated from time of a colorectal abnormality to diagnostic resolution. Control patients received usual care, and outcome information was obtained from medical record abstraction. Using a frailty Cox proportional hazard model, we examined the length of time between colorectal abnormality and definitive diagnosis. Results 193 patients were eligible for the study because of a colorectal cancer related abnormality (75 navigated; 118 control). Analysis of PN effect by two time periods of resolution (0-4 months and > 4 months) showed a lagged effect of PN. The adjusted time-varying PN effect on diagnostic resolution compared to control was marginally significant (adjusted Hazard Ratio, aHR=1.15, 95% CI: 1.02-1.29) after controlling for insurance status. The predicted aHR at 4 months was 1.2, but showed no significant effect until 12 months. Conclusions For patients having an abnormal symptom of CRC, PN appeared to have a positive effect over time and sped diagnostic resolution after 4 months. However, the small sample size limits drawing a definitive conclusion regarding the positive PN effect. PMID:24113902

Coupling gene-based and classic veterinary diagnostics improves interpretation of health and immune function in the Agassiz’s desert tortoise (Gopherus agassizii)

PubMed Central

Bowen, Lizabeth; Lewison, Rebecca L.; Esque, Todd C.; Nussear, Kenneth E.; Braun, Josephine; Waters, Shannon C.; Miles, A. Keith

2017-01-01

Abstract The analysis of blood constituents is a widely used tool to aid in monitoring of animal health and disease. However, classic blood diagnostics (i.e. hematologic and plasma biochemical values) often do not provide sufficient information to determine the state of an animal’s health. Field studies on wild tortoises and other reptiles have had limited success in drawing significant inferences between blood diagnostics and physiological and immunological condition. However, recent research using gene transcription profiling in the threatened Mojave desert tortoise (Gopherus agassizii) has proved useful in identifying immune or physiologic responses and overall health. To improve our understanding of health and immune function in tortoises, we evaluated both standard blood diagnostic (body condition, hematologic, plasma biochemistry values, trace elements, plasma proteins, vitamin A levels) and gene transcription profiles in 21 adult tortoises (11 clinically abnormal; 10 clinically normal) from Clark County, NV, USA. Necropsy and histology evaluations from clinically abnormal tortoises revealed multiple physiological complications, with moderate to severe rhinitis or pneumonia being the primary cause of morbidity in all but one of the examined animals. Clinically abnormal tortoises had increased transcription for four genes (SOD, MyD88, CL and Lep), increased lymphocyte production, biochemical enzymes and organics, trace elements of copper, and decreased numbers of leukocytes. We found significant positive correlations between increased transcription for SOD and increased trace elements for copper, as well as genes MyD88 and Lep with increased inflammation and microbial insults. Improved methods for health assessments are an important element of monitoring tortoise population recovery and can support the development of more robust diagnostic measures for ill animals, or individuals directly impacted by disturbance. PMID:28835840

Coupling gene-based and classic veterinary diagnostics improves interpretation of health and immune function in the Agassiz's desert tortoise (Gopherus agassizii).

PubMed

Drake, K Kristina; Bowen, Lizabeth; Lewison, Rebecca L; Esque, Todd C; Nussear, Kenneth E; Braun, Josephine; Waters, Shannon C; Miles, A Keith

2017-01-01

The analysis of blood constituents is a widely used tool to aid in monitoring of animal health and disease. However, classic blood diagnostics (i.e. hematologic and plasma biochemical values) often do not provide sufficient information to determine the state of an animal's health. Field studies on wild tortoises and other reptiles have had limited success in drawing significant inferences between blood diagnostics and physiological and immunological condition. However, recent research using gene transcription profiling in the threatened Mojave desert tortoise ( Gopherus agassizii ) has proved useful in identifying immune or physiologic responses and overall health. To improve our understanding of health and immune function in tortoises, we evaluated both standard blood diagnostic (body condition, hematologic, plasma biochemistry values, trace elements, plasma proteins, vitamin A levels) and gene transcription profiles in 21 adult tortoises (11 clinically abnormal; 10 clinically normal) from Clark County, NV, USA. Necropsy and histology evaluations from clinically abnormal tortoises revealed multiple physiological complications, with moderate to severe rhinitis or pneumonia being the primary cause of morbidity in all but one of the examined animals. Clinically abnormal tortoises had increased transcription for four genes (SOD, MyD88, CL and Lep), increased lymphocyte production, biochemical enzymes and organics, trace elements of copper, and decreased numbers of leukocytes. We found significant positive correlations between increased transcription for SOD and increased trace elements for copper, as well as genes MyD88 and Lep with increased inflammation and microbial insults. Improved methods for health assessments are an important element of monitoring tortoise population recovery and can support the development of more robust diagnostic measures for ill animals, or individuals directly impacted by disturbance.

Practical issues in implementing whole-genome-sequencing in routine diagnostic microbiology.

PubMed

Rossen, J W A; Friedrich, A W; Moran-Gilad, J

2018-04-01

Next generation sequencing (NGS) is increasingly being used in clinical microbiology. Like every new technology adopted in microbiology, the integration of NGS into clinical and routine workflows must be carefully managed. To review the practical aspects of implementing bacterial whole genome sequencing (WGS) in routine diagnostic laboratories. Review of the literature and expert opinion. In this review, we discuss when and how to integrate whole genome sequencing (WGS) in the routine workflow of the clinical laboratory. In addition, as the microbiology laboratories have to adhere to various national and international regulations and criteria for their accreditation, we deliberate on quality control issues for using WGS in microbiology, including the importance of proficiency testing. Furthermore, the current and future place of this technology in the diagnostic hierarchy of microbiology is described as well as the necessity of maintaining backwards compatibility with already established methods. Finally, we speculate on the question of whether WGS can entirely replace routine microbiology in the future and the tension between the fact that most sequencers are designed to process multiple samples in parallel whereas for optimal diagnosis a one-by-one processing of the samples is preferred. Special reference is made to the cost and turnaround time of WGS in diagnostic laboratories. Further development is required to improve the workflow for WGS, in particular to shorten the turnaround time, reduce costs, and streamline downstream data analyses. Only when these processes reach maturity will reliance on WGS for routine patient management and infection control management become feasible, enabling the transformation of clinical microbiology into a genome-based and personalized diagnostic field. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

DSM-5 AND ICD-11 DEFINITIONS OF POSTTRAUMATIC STRESS DISORDER: INVESTIGATING “NARROW” AND “BROAD” APPROACHES

PubMed Central

Stein, Dan J.; McLaughlin, Katie A.; Koenen, Karestan C.; Atwoli, Lukoye; Friedman, Matthew J.; Hill, Eric D.; Maercker, Andreas; Petukhova, Maria; Shahly, Victoria; van Ommeren, Mark; Alonso, Jordi; Borges, Guilherme; de Girolamo, Giovanni; de Jonge, Peter; Demyttenaere, Koen; Florescu, Silvia; Karam, Elie G.; Kawakami, Norito; Matschinger, Herbert; Okoliyski, Michail; Posada-Villa, Jose; Scott, Kate M.; Viana, Maria Carmen; Kessler, Ronald C.

2014-01-01

Background The development of the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) and ICD-11 has led to reconsideration of diagnostic criteria for posttraumatic stress disorder (PTSD). The World Mental Health (WMH) Surveys allow investigation of the implications of the changing criteria compared to DSM-IV and ICD-10. Methods WMH Surveys in 13 countries asked respondents to enumerate all their lifetime traumatic events (TEs) and randomly selected one TE per respondent for PTSD assessment. DSMIV and ICD-10 PTSD were assessed for the 23,936 respondents who reported lifetime TEs in these surveys with the fully structured Composite International Diagnostic Interview (CIDI). DSM-5 and proposed ICD-11 criteria were approximated. Associations of the different criteria sets with indicators of clinical severity (distress-impairment, suicidality, comorbid fear-distress disorders, PTSD symptom duration) were examined to investigate the implications of using the different systems. Results A total of 5.6% of respondents met criteria for “broadly defined” PTSD (i.e., full criteria in at least one diagnostic system), with prevalence ranging from 3.0% with DSM-5 to 4.4% with ICD-10. Only one-third of broadly defined cases met criteria in all four systems and another one third in only one system (narrowly defined cases). Between-system differences in indicators of clinical severity suggest that ICD-10 criteria are least strict and DSM-IV criteria most strict. The more striking result, though, is that significantly elevated indicators of clinical significance were found even for narrowly defined cases for each of the four diagnostic systems. Conclusions These results argue for a broad definition of PTSD defined by any one of the different systems to capture all clinically significant cases of PTSD in future studies. PMID:24894802

Accuracy of LightCycler(R) SeptiFast for the detection and identification of pathogens in the blood of patients with suspected sepsis: a systematic review protocol.

PubMed

Dark, Paul; Wilson, Claire; Blackwood, Bronagh; McAuley, Danny F; Perkins, Gavin D; McMullan, Ronan; Gates, Simon; Warhurst, Geoffrey

2012-01-01

Background There is growing interest in the potential utility of molecular diagnostics in improving the detection of life-threatening infection (sepsis). LightCycler® SeptiFast is a multipathogen probe-based real-time PCR system targeting DNA sequences of bacteria and fungi present in blood samples within a few hours. We report here the protocol of the first systematic review of published clinical diagnostic accuracy studies of this technology when compared with blood culture in the setting of suspected sepsis. Methods/design Data sources: the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects (DARE), the Health Technology Assessment Database (HTA), the NHS Economic Evaluation Database (NHSEED), The Cochrane Library, MEDLINE, EMBASE, ISI Web of Science, BIOSIS Previews, MEDION and the Aggressive Research Intelligence Facility Database (ARIF). diagnostic accuracy studies that compare the real-time PCR technology with standard culture results performed on a patient's blood sample during the management of sepsis. three reviewers, working independently, will determine the level of evidence, methodological quality and a standard data set relating to demographics and diagnostic accuracy metrics for each study. Statistical analysis/data synthesis: heterogeneity of studies will be investigated using a coupled forest plot of sensitivity and specificity and a scatter plot in Receiver Operator Characteristic (ROC) space. Bivariate model method will be used to estimate summary sensitivity and specificity. The authors will investigate reporting biases using funnel plots based on effective sample size and regression tests of asymmetry. Subgroup analyses are planned for adults, children and infection setting (hospital vs community) if sufficient data are uncovered. Dissemination Recommendations will be made to the Department of Health (as part of an open-access HTA report) as to whether the real-time PCR technology has sufficient clinical diagnostic accuracy potential to move forward to efficacy testing during the provision of routine clinical care. Registration PROSPERO-NIHR Prospective Register of Systematic Reviews (CRD42011001289).

Validation of consensus panel diagnosis in dementia.

PubMed

Gabel, Matthew J; Foster, Norman L; Heidebrink, Judith L; Higdon, Roger; Aizenstein, Howard J; Arnold, Steven E; Barbas, Nancy R; Boeve, Bradley F; Burke, James R; Clark, Christopher M; Dekosky, Steven T; Farlow, Martin R; Jagust, William J; Kawas, Claudia H; Koeppe, Robert A; Leverenz, James B; Lipton, Anne M; Peskind, Elaine R; Turner, R Scott; Womack, Kyle B; Zamrini, Edward Y

2010-12-01

The clinical diagnosis of dementing diseases largely depends on the subjective interpretation of patient symptoms. Consensus panels are frequently used in research to determine diagnoses when definitive pathologic findings are unavailable. Nevertheless, research on group decision making indicates that many factors can adversely affect panel performance. To determine conditions that improve consensus panel diagnosis. Comparison of neuropathologic diagnoses with individual and consensus panel diagnoses based on clinical scenarios only, fludeoxyglucose F 18 positron emission tomography images only, and scenarios plus images. Expert and trainee individual and consensus panel deliberations using a modified Delphi method in a pilot research study of the diagnostic utility of fludeoxyglucose F 18 positron emission tomography. Forty-five patients with pathologically confirmed Alzheimer disease or frontotemporal dementia. Statistical measures of diagnostic accuracy, agreement, and confidence for individual raters and panelists before and after consensus deliberations. The consensus protocol using trainees and experts surpassed the accuracy of individual expert diagnoses when clinical information elicited diverse judgments. In these situations, consensus was 3.5 times more likely to produce positive rather than negative changes in the accuracy and diagnostic certainty of individual panelists. A rule that forced group consensus was at least as accurate as majority and unanimity rules. Using a modified Delphi protocol to arrive at a consensus diagnosis is a reasonable substitute for pathologic information. This protocol improves diagnostic accuracy and certainty when panelist judgments differ and is easily adapted to other research and clinical settings while avoiding the potential pitfalls of group decision making.

Comparison of laser spectroscopic PNC method with laser integral fluorescence in optical caries diagnostics

NASA Astrophysics Data System (ADS)

Masychev, Victor I.

2001-05-01

In this research we represent the results of approbation of two methods of optical caries diagnostics: PNC-spectral diagnostics and caries detection by laser integral fluorescence. The research was conducted in a dental clinic. PNC-method analyzes parameters of probing laser radiation and PNC-spectrums of stimulated secondary radiations: backscattering and endogenous fluorescence of caries- involved bacteria. Ia-Ne laser ((lambda) equals632.8 nm, 1-2 mW) was used as a source of probing (stimulated) radiation. For registration of signals, received from intact and pathological teeth PDA-detector was applied. PNC-spectrums were processed by special algorithms, and were displayed on PC monitor. The method of laser integral fluorescence was used for comparison. In this case integral power of fluorescence of human teeth was measured. As a source of probing (stimulated) radiation diode lasers ((lambda) equals655 nm, 0.1 mW and 630 nm, 1 mW) and Ia-Na laser were applied. For registration of signals Si-photodetector was used. Integral power was shown in a digital indicator. Advantages and disadvantages of these methods are described in this research. It is disclosed that the method of laser integral power of fluorescence has the following characteristics: simplicity of construction and schema-technical decisions. However the method of PNC-spectral diagnostics are characterized by considerably more sensitivity in diagnostics of initial caries and capability to differentiate pathologies of various stages (for example, calculus/initial caries). Estimation of spectral characteristics of PNC-signals allows eliminating a number of drawbacks, which are character for detection by method of laser integral fluorescence (for instance, detection of fluorescent fillings, plagues, calculus, discolorations generally, amalgam, gold fillings as if it were caries).

Evaluation of gastric emptying function in clinical practice.

PubMed

Poitras, P; Picard, M; Déry, R; Giguère, A; Picard, D; Morais, J; Plourde, V; Boivin, M

1997-11-01

In this retrospective analysis, we compared different methods to evaluate gastric emptying function, aiming to improve the sensitivity and the clinical availability of our diagnostic testing. In the first study, we compared, in 72 patients clinically suspected of gastroparesis, the emptying of a meal containing two solid nutrients with different disintegration rates: 111In-labeled scrambled eggs and 99Tc-labeled liver cubes. Gastric emptying of 111In-labeled egg was delayed in 12 of our patients and the evacuation of the 99Tc-labeled liver was prolonged in 19 patients. The choice of the nutrient was not important for the identification of diabetic gastroparesis (43% vs 57%; NS), but it was determinant in the case of patients suspected of idiopathic gastroparesis (12% were positive with the egg and 25% with the liver; P < 0.05). In the second study, we compared two different diagnostic methods in 46 patients: a simple radiological detection of the gastric emptying of radiopaque pellets, and the scintigraphic emptying of a solid meal containing 99Tc-labeled liver cubes. Both tests correlated perfectly in 78% of our patients. In 15% of the population (six of these seven patients were diabetics suspected of gastroparesis) the scintigraphic method was normal, while the evacuation of radiopaque pellets was delayed. For clinical purposes, we therefore propose: (1) the scintigraphic method should use liver rather than egg as a radiolabeled tracer in order to improve the sensitivity of the test for detection of gastroparesis; and (2) the radiological detection of radiopaque markers is a reliable and convenient method for the detection of gastroparesis in clinical practice. It is possibly more sensitive than scintigraphy.

Laboratory Diagnosis of Congenital Toxoplasmosis.

PubMed

Pomares, Christelle; Montoya, Jose G

2016-10-01

Recent studies have demonstrated that screening and treatment for toxoplasmosis during gestation result in a decrease of vertical transmission and clinical sequelae. Early treatment was associated with improved outcomes. Thus, laboratory methods should aim for early identification of infants with congenital toxoplasmosis (CT). Diagnostic approaches should include, at least, detection of Toxoplasma IgG, IgM, and IgA and a comprehensive review of maternal history, including the gestational age at which the mother was infected and treatment. Here, we review laboratory methods for the diagnosis of CT, with emphasis on serological tools. A diagnostic algorithm that takes into account maternal history is presented. Copyright © 2016 Pomares and Montoya.

Clinical instrumentation and applications of Raman spectroscopy

PubMed Central

Pence, Isaac

2016-01-01

Clinical diagnostic devices provide new sources of information that give insight about the state of health which can then be used to manage patient care. These tools can be as simple as an otoscope to better visualize the ear canal or as complex as a wireless capsule endoscope to monitor the gastrointestinal tract. It is with tools such as these that medical practitioners can determine when a patient is healthy and to make an appropriate diagnosis when he/she is not. The goal of diagnostic medicine then is to efficiently determine the presence and cause of disease in order to provide the most appropriate intervention. The earliest form of medical diagnostics relied on the eye – direct visual observation of the interaction of light with the sample. This technique was espoused by Hippocrates in his 5th century BCE work Epidemics, in which the pallor of a patient’s skin and the coloring of the bodily fluids could be indicative of health. In the last hundred years, medical diagnosis has moved from relying on visual inspection to relying on numerous technological tools that are based on various types of interaction of the sample with different types of energy – light, ultrasound, radio waves, X-rays etc. Modern advances in science and technology have depended on enhancing technologies for the detection of these interactions for improved visualization of human health. Optical methods have been focused on providing this information in the micron to millimeter scale while ultrasound, X-ray, and radio waves have been key in aiding in the millimeter to centimeter scale. While a few optical technologies have achieved the status of medical instruments, many remain in the research and development phase despite persistent efforts by many researchers in the translation of these methods for clinical care. Of these, Raman spectroscopy has been described as a sensitive method that can provide biochemical information about tissue state while maintaining the capability of delivering this information in real-time, non-invasively, and in an automated manner. This review presents the various instrumentation considerations relevant to the clinical implementation of Raman spectroscopy and reviews a subset of interesting applications that have successfully demonstrated the efficacy of this technique for clinical diagnostics and monitoring in large (n ≥ 50) in vivo human studies. PMID:26999370

A systematic review of methods to diagnose oral dryness and salivary gland function

PubMed Central

2012-01-01

Background The most advocated clinical method for diagnosing salivary dysfunction is to quantitate unstimulated and stimulated whole saliva (sialometry). Since there is an expected and wide variation in salivary flow rates among individuals, the assessment of dysfunction can be difficult. The aim of this systematic review is to evaluate the quality of the evidence for the efficacy of diagnostic methods used to identify oral dryness. Methods A literature search, with specific indexing terms and a hand search, was conducted for publications that described a method to diagnose oral dryness. The electronic databases of PubMed, Cochrane Library, and Web of Science were used as data sources. Four reviewers selected publications on the basis of predetermined inclusion and exclusion criteria. Data were extracted from the selected publications using a protocol. Original studies were interpreted with the aid of Quality Assessment of Diagnostic Accuracy Studies (QUADAS) tool. Results The database searches resulted in 224 titles and abstracts. Of these abstracts, 80 publications were judged to meet the inclusion criteria and read in full. A total of 18 original studies were judged relevant and interpreted for this review. In all studies, the results of the test method were compared to those of a reference method. Based on the interpretation (with the aid of the QUADAS tool) it can be reported that the patient selection criteria were not clearly described and the test or reference methods were not described in sufficient detail for it to be reproduced. None of the included studies reported information on uninterpretable/intermediate results nor data on observer or instrument variation. Seven of the studies presented their results as a percentage of correct diagnoses. Conclusions The evidence for the efficacy of clinical methods to assess oral dryness is sparse and it can be stated that improved standards for the reporting of diagnostic accuracy are needed in order to assure the methodological quality of studies. There is need for effective diagnostic criteria and functional tests in order to detect those individuals with oral dryness who may require oral treatment, such as alleviation of discomfort and/or prevention of diseases. PMID:22870895

Frequency and Clinical Epidemiology of Canine Monocytic Ehrlichiosis in Dogs Infested with Ticks from Sinaloa, Mexico

PubMed Central

Sosa-Gutierrez, Carolina Guadalupe; Quintero Martinez, Maria Teresa; Gaxiola Camacho, Soila Maribel; Esteve-Gassent, Maria D.; Gordillo-Pérez, María-Guadalupe

2013-01-01

Ehrlichia canis is a rickettsial intracellular obligate bacterial pathogen and agent of canine monocytic ehrlichiosis. The prevalence of this disease in veterinary medicine can vary depending on the diagnostic method used and the geographic location. One hundred and fifty-two canine blood samples from six veterinary clinics and two shelters from Sinaloa State (Mexico) were analyzed in this study. All animals were suspected of having Canine Monocytic Ehrlichiosis (CME). The diagnostic methods used were the ELISA (Snap4Dx, IDEXX) together with blood smear and platelet count. From all dogs blood samples analyzed, 74.3% were positive to E. canis by ELISA and 40.1% were positive by blood smear. The sensitivity and specificity observed in the ELISA test were 78.8% and 86.7%. In addition, thrombocytopenia was presented in 87.6% of positive dogs. The predominant clinical manifestations observed were fever, anorexia, depression, lethargy, and petechiae. Consequently, this is the first report in which the morulae were visualized in the blood samples, and E. canis-specific antibodies were detected in dogs from Sinaloa, Northwest of Mexico. PMID:26464910

[Descartes' influence on the development of the anatomoclinical method].

PubMed

González Hernández, A; Domínguez Rodríguez, M V; Fabre Pi, O; Cubero González, A

2010-01-01

The development of the anatomical-clinical method was a huge advance for modern medicine since it revealed a new approach to understanding diagnostic procedures. This change in medical thinking towards a more scientific basis has gradually evolved over several centuries, reaching its brilliant zenith with the contributions of the French school. There are certain similarities between the guidelines of the anatomical-clinical method and René Descartes' philosophical principles, so it is fair to consider him as one of the major precursors in this new line of thinking that definitely influenced the historical course of medicine.

Investigating the use of an antiscatter grid in chest radiography for average adults with a computed radiography imaging system

PubMed Central

Wood, T J; Avery, G; Balcam, S; Needler, L; Smith, A; Saunderson, J R; Beavis, A W

2015-01-01

Objective: The aim of this study was to investigate via simulation a proposed change to clinical practice for chest radiography. The validity of using a scatter rejection grid across the diagnostic energy range (60–125 kVp), in conjunction with appropriate tube current–time product (mAs) for imaging with a computed radiography (CR) system was investigated. Methods: A digitally reconstructed radiograph algorithm was used, which was capable of simulating CR chest radiographs with various tube voltages, receptor doses and scatter rejection methods. Four experienced image evaluators graded images with a grid (n = 80) at tube voltages across the diagnostic energy range and varying detector air kermas. These were scored against corresponding images reconstructed without a grid, as per current clinical protocol. Results: For all patients, diagnostic image quality improved with the use of a grid, without the need to increase tube mAs (and therefore patient dose), irrespective of the tube voltage used. Increasing tube mAs by an amount determined by the Bucky factor made little difference to image quality. Conclusion: A virtual clinical trial has been performed with simulated chest CR images. Results indicate that the use of a grid improves diagnostic image quality for average adults, without the need to increase tube mAs, even at low tube voltages. Advances in knowledge: Validated with images containing realistic anatomical noise, it is possible to improve image quality by utilizing grids for chest radiography with CR systems without increasing patient exposure. Increasing tube mAs by an amount determined by the Bucky factor is not justified. PMID:25571914

Improved DNA hybridization parameters by Twisted Intercalating Nucleic Acid (TINA).

PubMed

Schneider, Uffe Vest

2012-01-01

This thesis establishes oligonucleotide design rules and applications of a novel group of DNA stabilizing molecules collectively called Twisted Intercalating Nucleic Acid - TINA. Three peer-reviewed publications form the basis for the thesis. One publication describes an improved and rapid method for determination of DNA melting points and two publications describe the effects of positioning TINA molecules in parallel triplex helix and antiparallel duplex helix forming DNA structures. The third publication establishes that TINA molecules containing oligonucleotides improve an antiparallel duplex hybridization based capture assay's analytical sensitivity compared to conventionel DNA oligonucleotides. Clinical microbiology is traditionally based on pathogenic microorganisms' culture and serological tests. The introduction of DNA target amplification methods like PCR has improved the analytical sensitivity and total turn around time involved in clinical diagnostics of infections. Due to the relatively weak hybridization between the two strands of double stranded DNA, a number of nucleic acid stabilizing molecules have been developed to improve the sensitivity of DNA based diagnostics through superior binding properties. A short introduction is given to Watson-Crick and Hoogsteen based DNA binding and the derived DNA structures. A number of other nucleic acid stabilizing molecules are described. The stabilizing effect of TINA molecules on different DNA structures is discussed and considered in relation to other nucleic acid stabilizing molecules and in relation to future use of TINA containing oligonucleotides in clinical diagnostics and therapy. In conclusion, design of TINA modified oligonucleotides for antiparallel duplex helixes and parallel triplex helixes follows simple purpose dependent rules. TINA molecules are well suited for improving multiplex PCR assays and can be used as part of novel technologies. Future research should test whether combinations of TINA molecules and other nucleic acid stabilizing molecules can increase analytical sensitivity whilst maintaining nucleobase mismatch discrimination in triplex helix based diagnostic assays.

Sensitivity and specificity of the amer dizziness diagnostic scale (adds) for patients with vestibular disorders.

PubMed

Al Saif, Amer; Alsenany, Samira

2015-01-01

[Purpose] To investigate the sensitivity and specificity of a newly developed diagnostic tool, the Amer Dizziness Diagnostic Scale (ADDS), to evaluate and differentially diagnose vestibular disorder and to identify the strengths and weaknesses of the scale and its usefulness in clinical practice. [Subjects and Methods] Two hundred subjects of both genders (72 males, 128 females) aged between 18 to 60 (49.5±7.8) who had a history of vertigo and/or dizziness symptoms for this previous two weeks or less were recruited for the study. All subjects were referred by otolaryngologists, neurologists or family physicians in and around Jeddah, Kingdom of Saudi Arabia. On the first clinic visit, all the patients were evaluated once using the ADDS, following which they underwent routine testing of clinical signs and symptoms, audiometry, and a neurological examination, coupled with tests of Vestibulo-Ocular Reflex function, which often serves as the "gold standard" for determining the probability of a vestibular deficit. [Results] The results show that the ADDS strongly correlated with "true-positive" and "true-negative" responses for determining the probability of a vestibular disorder (r =0.95). A stepwise linear regression was conducted and the results indicate that the ADDS was a significant predictor of "true-positive" and "true-negative" responses in vestibular disorders (R(2) =0.90). Approximately 90% of the variability in the vestibular gold standard test was explained by its relationship to the ADDS. Moreover, the ADDS was found to have a sensitivity of 96% and a specificity of 96%. [Conclusion] This study showed that the Amer Dizziness Diagnostic Scale has high sensitivity and specificity and that it can be used as a method of differential diagnosis for patients with vestibular disorders.

Development and validation of the JAX Cancer Treatment Profile™ for detection of clinically actionable mutations in solid tumors

PubMed Central

Ananda, Guruprasad; Mockus, Susan; Lundquist, Micaela; Spotlow, Vanessa; Simons, Al; Mitchell, Talia; Stafford, Grace; Philip, Vivek; Stearns, Timothy; Srivastava, Anuj; Barter, Mary; Rowe, Lucy; Malcolm, Joan; Bult, Carol; Karuturi, Radha Krishna Murthy; Rasmussen, Karen; Hinerfeld, Douglas

2015-01-01

Background The continued development of targeted therapeutics for cancer treatment has required the concomitant development of more expansive methods for the molecular profiling of the patient’s tumor. We describe the validation of the JAX Cancer Treatment Profile™ (JAX-CTP™), a next generation sequencing (NGS)-based molecular diagnostic assay that detects actionable mutations in solid tumors to inform the selection of targeted therapeutics for cancer treatment. Methods NGS libraries are generated from DNA extracted from formalin fixed paraffin embedded tumors. Using hybrid capture, the genes of interest are enriched and sequenced on the Illumina HiSeq 2500 or MiSeq sequencers followed by variant detection and functional and clinical annotation for the generation of a clinical report. Results The JAX-CTP™ detects actionable variants, in the form of single nucleotide variations and small insertions and deletions (≤50bp) in 190 genes in specimens with a neoplastic cell content of ≥10%. The JAX-CTP™ is also validated for the detection of clinically actionable gene amplifications. Conclusions There is a lack of consensus in the molecular diagnostics field on the best method for the validation of NGS-based assays in oncology, thus the importance of communicating methods, as contained in this report. The growing number of targeted therapeutics and the complexity of the tumor genome necessitates continued development and refinement of advanced assays for tumor profiling to enable precision cancer treatment. PMID:25562415

Exploring cognitive integration of basic science and its effect on diagnostic reasoning in novices.

PubMed

Lisk, Kristina; Agur, Anne M R; Woods, Nicole N

2016-06-01

Integration of basic and clinical science knowledge is increasingly being recognized as important for practice in the health professions. The concept of 'cognitive integration' places emphasis on the value of basic science in providing critical connections to clinical signs and symptoms while accounting for the fact that clinicians may not spontaneously articulate their use of basic science knowledge in clinical reasoning. In this study we used a diagnostic justification test to explore the impact of integrated basic science instruction on novices' diagnostic reasoning process. Participants were allocated to an integrated basic science or clinical science training group. The integrated basic science group was taught the clinical features along with the underlying causal mechanisms of four musculoskeletal pathologies while the clinical science group was taught only the clinical features. Participants completed a diagnostic accuracy test immediately after initial learning, and one week later a diagnostic accuracy and justification test. The results showed that novices who learned the integrated causal mechanisms had superior diagnostic accuracy and better understanding of the relative importance of key clinical features. These findings further our understanding of cognitive integration by providing evidence of the specific changes in clinical reasoning when basic and clinical sciences are integrated during learning.

The Accuracy of Diagnostic Tests for Lyme Disease in Humans, A Systematic Review and Meta-Analysis of North American Research.

PubMed

Waddell, Lisa A; Greig, Judy; Mascarenhas, Mariola; Harding, Shannon; Lindsay, Robbin; Ogden, Nicholas

2016-01-01

There has been an increasing incidence of Lyme disease (LD) in Canada and the United States corresponding to the expanding range of the Ixodes tick vector and Lyme disease agent (Borrelia burgdorferi sensu stricto). There are many diagnostic tests for LD available in North America, all of which have some performance issues, and physicians are concerned about the appropriate use and interpretation of these tests. The objective of this systematic review is to summarize the North American evidence on the accuracy of diagnostic tests and test regimes at various stages of LD. Included in the review are 48 studies on diagnostic tests used in North America published since 1995. Thirteen studies examined a two-tier serological test protocol vs. clinical diagnosis, 24 studies examined single assays vs. clinical diagnosis, 9 studies examined single immunoblot vs. clinical diagnosis, 7 studies compared culture or PCR direct detection methods vs. clinical diagnosis, 22 studies compared two or more tests with each other and 8 studies compared a two-tiered serological test protocol to another test. Recent studies examining the sensitivity and specificity of various test protocols noted that the Immunetics® C6 B. burgdorferi ELISA™ and the two tier approach have superior specificity compared to proposed replacements, and the CDC recommended western blot algorithm has equivalent or superior specificity over other proposed test algorithms. There is a dramatic increase in test sensitivity with progression of B. burgdorferi infection from early to late LD. Direct detection methods, culture and PCR of tissue or blood samples were not as sensitive or timely compared to serological testing. It was also noted that there are a large number of both commercial (n = 42) and in-house developed tests used by private laboratories which have not been evaluated in the primary literature.

The Accuracy of Diagnostic Tests for Lyme Disease in Humans, A Systematic Review and Meta-Analysis of North American Research

PubMed Central

Lindsay, Robbin; Ogden, Nicholas

2016-01-01

There has been an increasing incidence of Lyme disease (LD) in Canada and the United States corresponding to the expanding range of the Ixodes tick vector and Lyme disease agent (Borrelia burgdorferi sensu stricto). There are many diagnostic tests for LD available in North America, all of which have some performance issues, and physicians are concerned about the appropriate use and interpretation of these tests. The objective of this systematic review is to summarize the North American evidence on the accuracy of diagnostic tests and test regimes at various stages of LD. Included in the review are 48 studies on diagnostic tests used in North America published since 1995. Thirteen studies examined a two-tier serological test protocol vs. clinical diagnosis, 24 studies examined single assays vs. clinical diagnosis, 9 studies examined single immunoblot vs. clinical diagnosis, 7 studies compared culture or PCR direct detection methods vs. clinical diagnosis, 22 studies compared two or more tests with each other and 8 studies compared a two-tiered serological test protocol to another test. Recent studies examining the sensitivity and specificity of various test protocols noted that the Immunetics® C6 B. burgdorferi ELISA™ and the two tier approach have superior specificity compared to proposed replacements, and the CDC recommended western blot algorithm has equivalent or superior specificity over other proposed test algorithms. There is a dramatic increase in test sensitivity with progression of B. burgdorferi infection from early to late LD. Direct detection methods, culture and PCR of tissue or blood samples were not as sensitive or timely compared to serological testing. It was also noted that there are a large number of both commercial (n = 42) and in-house developed tests used by private laboratories which have not been evaluated in the primary literature. PMID:28002488

Diagnostic methods for assessing maxillary skeletal and dental transverse deficiencies: A systematic review

PubMed Central

Sawchuk, Dena; Currie, Kris; Vich, Manuel Lagravere; Palomo, Juan Martin

2016-01-01

Objective To evaluate the accuracy and reliability of the diagnostic tools available for assessing maxillary transverse deficiencies. Methods An electronic search of three databases was performed from their date of establishment to April 2015, with manual searching of reference lists of relevant articles. Articles were considered for inclusion if they reported the accuracy or reliability of a diagnostic method or evaluation technique for maxillary transverse dimensions in mixed or permanent dentitions. Risk of bias was assessed in the included articles, using the Quality Assessment of Diagnostic Accuracy Studies tool-2. Results Nine articles were selected. The studies were heterogeneous, with moderate to low methodological quality, and all had a high risk of bias. Four suggested that the use of arch width prediction indices with dental cast measurements is unreliable for use in diagnosis. Frontal cephalograms derived from cone-beam computed tomography (CBCT) images were reportedly more reliable for assessing intermaxillary transverse discrepancies than posteroanterior cephalograms. Two studies proposed new three-dimensional transverse analyses with CBCT images that were reportedly reliable, but have not been validated for clinical sensitivity or specificity. No studies reported sensitivity, specificity, positive or negative predictive values or likelihood ratios, or ROC curves of the methods for the diagnosis of transverse deficiencies. Conclusions Current evidence does not enable solid conclusions to be drawn, owing to a lack of reliable high quality diagnostic studies evaluating maxillary transverse deficiencies. CBCT images are reportedly more reliable for diagnosis, but further validation is required to confirm CBCT's accuracy and diagnostic superiority. PMID:27668196

Machine Learning Approach to Extract Diagnostic and Prognostic Thresholds: Application in Prognosis of Cardiovascular Mortality

PubMed Central

Mena, Luis J.; Orozco, Eber E.; Felix, Vanessa G.; Ostos, Rodolfo; Melgarejo, Jesus; Maestre, Gladys E.

2012-01-01

Machine learning has become a powerful tool for analysing medical domains, assessing the importance of clinical parameters, and extracting medical knowledge for outcomes research. In this paper, we present a machine learning method for extracting diagnostic and prognostic thresholds, based on a symbolic classification algorithm called REMED. We evaluated the performance of our method by determining new prognostic thresholds for well-known and potential cardiovascular risk factors that are used to support medical decisions in the prognosis of fatal cardiovascular diseases. Our approach predicted 36% of cardiovascular deaths with 80% specificity and 75% general accuracy. The new method provides an innovative approach that might be useful to support decisions about medical diagnoses and prognoses. PMID:22924062

Sensitivity and specificity of proposed DSM-5 diagnostic criteria for autism spectrum disorder Running Head: DSM-5 ASD

PubMed Central

McPartland, James C.; Reichow, Brian; Volkmar, Fred R.

2012-01-01

Objective This study evaluated the potential impact of proposed DSM-5 diagnostic criteria for autism spectrum disorder (ASD). Method This study focused on a sample of 977 participants evaluated during the DSM-IV field trial; 657 carried a clinical diagnosis of an ASD, and 276 were diagnosed with a non-autistic disorder. Sensitivity and specificity for proposed DSM-5 diagnostic criteria were evaluated using field trial symptom checklists as follows: (a) individual field trial checklist items (e.g., nonverbal communication), (b) checklist items grouped together as described by a single DSM-5 symptom (e.g., nonverbal and verbal communication), (c) individual DSM-5 criterion (e.g., social-communicative impairment), and (d) overall diagnostic criteria. Results When applying proposed DSM-5 diagnostic criteria for ASD, 60.6% (95% confidence interval: 57–64%) of cases with a clinical diagnosis of an ASD met revised DSM-5 diagnostic criteria for ASD. Overall specificity was high, with 94.9% (95% confidence interval: 92–97%) of individuals accurately excluded from the spectrum. Sensitivity varied by diagnostic subgroup (Autistic Disorder =.76; Asperger’s Disorder = .25; PDD-NOS = .28) and cognitive ability (IQ < 70 = .70; IQ ≥ 70 = .46). Conclusions Proposed DSM-5 criteria substantially alter the composition of the autism spectrum. Revised criteria improve specificity, but exclude a substantial portion of cognitively able individuals and those with ASDs other than Autistic Disorder. A more stringent diagnostic rubric holds significant public health ramifications regarding service eligibility and compatibility of historical and future research. PMID:22449643

Clostridium difficile infection in patients with inflammatory bowel disease

PubMed Central

Saidel-Odes, Lisa; Borer, Abraham; Odes, Selwyn

2011-01-01

Clostridium difficile infection in patients with inflammatory bowel disease has become a serious clinical problem over the past few years. This review is focused on the current changes in epidemiology, pertinent clinical aspects, standard and newer diagnostic methods, established and novel therapies, and prevention of infection. There is emphasis on the importance of clinical awareness, rapid detection by stool testing, and appropriate antibiotic therapy, while newer technologies, antibiotics and other treatments are explored. PMID:24713726

Clinical characteristic of amoebic liver abscesses in the North of Iraq.

PubMed

Baban, F A

2000-06-01

The purpose of the study was to find out the clinical characteristic of amoebic liver abscesses in this area, the simplest method for diagnosis and to determine the effectiveness of treatment by metronidazole therapy proved by disappearance of symptoms and regression in the size of the abscesses by ultrasound. We studied prospectively all cases of suspected liver abscesses admitted to our unit over 2 years (1990 & 1991). A special case sheet was prepared. Daily follow up of patients was carried out in hospital for at least 10 days. Patients were later followed up by ultrasound after discharge. We compared the rate of infection from the hospital records over the last 9 years up to the end of 1998. We found the clinical features of the disease similar to those mentioned in essential text books of medicine, except that pain is not always epigastric while fever may be absent and hepatomegaly is not marked. Ultrasound is a simple, cheap diagnostic test, which is available. Metronidazole is an effective treatment and none of the patients required an invasive method for diagnosis or treatment. None had secondary bacterial infection. Amoebic liver abscess if untreated is a grave disorder. We concluded that recognizing the disorder clinically and proving it by ultrasound is the main method for diagnostic confirmation. Following the hospital records of the last 9 years, it seems that the rate of infection is declining in this area.

EVALUATION AND IMPORTANCE OF SELECTED MICROBIOLOGICAL METHODS IN THE DIAGNOSIS OF HUMAN BRUCELLOSIS

PubMed Central

Šiširak, Maida; Hukić, Mirsada

2009-01-01

Brucellosis is an important public health problem in Bosnia and Herzegovina. The diagnosis of bru-cellosis in the country without any experiences with this kind of infection may be very difficult. The aim of this study was to evaluate diagnostic methods: Rose Bengal test, blood cultures and ELISA IgM and IgG in the patients with brucellosis. The study included 91 brucellosis patients in the period 2004 to 2007. All the patients were treated at the Clinic for Infectious Diseases, University of Sarajevo Clinics Centre. Blood cultures were positive in 28/91 (30, 8%) patients. This method often needs a long period of incubation and specimens need to be obtained early. These limitations make serology the most useful tool for the laboratory diagnosis of Brucella infection. Rose Bengal is a rapid plate agglutination test, very sensitive irrespective of the stage of the disease. In our study, Rose Bengal test was positive in all patients 91/91 (100, 0%). Brucella IgM antibodies with ELISA were positive in 59/91 (64, 8%). Brucella IgG antibodies with ELISA were positive in 51/91 (56%). In order to determine the diagnostic value of the different tests, we compared the sensitivity among test-methods: Rose Bengal test-100.0%, blood culture-30.8%, ELISA IgM-64.8% and ELISA IgG-56.1%. Sensitivity of test methods was different in the different stages of illness. It is necessary to use combination of different tests such are blood culture, Rose Bengal test and ELISA in order to ensure the diagnosis. Rose Bengal test is excellent for the screening. Blood culture is a method of choice for the diagnosis acute infection. ELISA is a very good method for the diagnostic chronic disease and relapse. PMID:19754473

Biomarker detection of global infectious diseases based on magnetic particles.

PubMed

Carinelli, Soledad; Martí, Mercè; Alegret, Salvador; Pividori, María Isabel

2015-09-25

Infectious diseases affect the daily lives of millions of people all around the world, and are responsible for hundreds of thousands of deaths, mostly in the developing world. Although most of these major infectious diseases are treatable, the early identification of individuals requiring treatment remains a major issue. The incidence of these diseases would be reduced if rapid diagnostic tests were widely available at the community and primary care level in low-resource settings. Strong research efforts are thus being focused on replacing standard clinical diagnostic methods, such as the invasive detection techniques (biopsy or endoscopy) or expensive diagnostic and monitoring methods, by affordable and sensitive tests based on novel biomarkers. The development of new methods that are needed includes solid-phase separation techniques. In this context, the integration of magnetic particles within bioassays and biosensing devices is very promising since they greatly improve the performance of a biological reaction. The diagnosis of clinical samples with magnetic particles can be easily achieved without pre-enrichment, purification or pretreatment steps often required for standard methods, simplifying the analytical procedures. The biomarkers can be specifically isolated and preconcentrated from complex biological matrixes by magnetic actuation, increasing specificity and the sensitivity of the assay. This review addresses these promising features of the magnetic particles for the detection of biomarkers in emerging technologies related with infectious diseases affecting global health, such as malaria, influenza, dengue, tuberculosis or HIV. Copyright © 2015 Elsevier B.V. All rights reserved.

Diagnostic performance of a rapid in-clinic test for the detection of Canine Parvovirus under different storage conditions and vaccination status.

PubMed

Kantere, Maria C; Athanasiou, Labrini V; Spyrou, Vassiliki; Kyriakis, Constantinos S; Kontos, Vassilios; Chatzopoulos, Dimitrios C; Tsokana, Constantina N; Billinis, Charalambos

2015-04-01

Canine parvovirus (CPV) is one of the most common causes of acute haemorrhagic enteritis in young dogs, while clinical diagnosis is often indecisive. The aim of our study was to evaluate the diagnostic accuracy of an in-clinic rapid test in the detection of CPV infection in dogs. To this end, we compared the Rapid Diagnostic Kit of Canine Parvovirus, Coronavirus and Rotavirus antigen (Quicking(®)) to PCR, which is considered as the most reliable diagnostic method. A total of 78 duplicated faecal samples were collected from diarrhoeic dogs. Vaccination history within a month prior to the onset of diarrhoea was reported for 12 of the sampled dogs. The rapid diagnostic test was performed in 23 of the faecal samples directly, while the rest were placed into a sterile cotton tipped swab suitable for collection and transportation of viruses (Sigma Σ-VCM(®)) and stored at -20 °C. The sensitivity of the Quicking rapid diagnostic test compared to PCR in the total number of samples, in samples from non-vaccinated dogs and in samples tested directly after collection were 22.22% (95% CI: 13.27-33.57%), 26.67% (95% CI: 16.08-39.66%) and 76.47% (95% CI: 50.10-93.04%) respectively, while the specificity of the test was 100% in any case. In conclusion, negative results do not exclude parvoenteritis from the differential diagnosis, especially in dogs with early vaccination history, but a positive result almost certainly indicates CPV infection. An improved sensitivity may be expected when the test is performed immediately. Copyright © 2015 Elsevier B.V. All rights reserved.

Diagnosing cancer in primary care: results from the National Cancer Diagnosis Audit

PubMed Central

Swann, Ruth; McPhail, Sean; Witt, Jana; Shand, Brian; Abel, Gary A; Hiom, Sara; Rashbass, Jem; Lyratzopoulos, Georgios; Rubin, Greg

2018-01-01

Background Continual improvements in diagnostic processes are needed to minimise the proportion of patients with cancer who experience diagnostic delays. Clinical audit is a means of achieving this. Aim To characterise key aspects of the diagnostic process for cancer and to generate baseline measures for future re-audit. Design and setting Clinical audit of cancer diagnosis in general practices in England. Method Information on patient and tumour characteristics held in the English National Cancer Registry was supplemented by information from GPs in participating practices. Data items included diagnostic timepoints, patient characteristics, and clinical management. Results Data were collected on 17 042 patients with a new diagnosis of cancer during 2014 from 439 practices. Participating practices were similar to non-participating ones, particularly regarding population age, urban/rural location, and practice-based patient experience measures. The median diagnostic interval for all patients was 40 days (interquartile range [IQR] 15–86 days). Most patients were referred promptly (median primary care interval 5 days [IQR 0–27 days]). Where GPs deemed diagnostic delays to have occurred (22% of cases), patient, clinician, or system factors were responsible in 26%, 28%, and 34% of instances, respectively. Safety netting was recorded for 44% of patients. At least one primary care-led investigation was carried out for 45% of patients. Most patients (76%) had at least one existing comorbid condition; 21% had three or more. Conclusion The findings identify avenues for quality improvement activity and provide a baseline for future audit of the impact of 2015 National Institute for Health and Care Excellence guidance on management and referral of suspected cancer. PMID:29255111

Recent advances in photodynamic diagnosis of gastric cancer using 5-aminolevulinic acid.

PubMed

Koizumi, Noriaki; Harada, Yoshinori; Minamikawa, Takeo; Tanaka, Hideo; Otsuji, Eigo; Takamatsu, Tetsuro

2016-01-21

Photodynamic diagnosis based on 5-aminolevulinic acid-induced protoporphyrin IX has been clinically applied in many fields based upon its evidenced efficacy and adequate safety. In order to establish a personalized medicine approach for treating gastric cancer patients, rapid intraoperative detection of malignant lesions has become important. Feasibility of photodynamic diagnosis using 5-aminolevulinic acid for gastric cancer patients has been investigated, especially for the detection of peritoneal dissemination and lymph node metastasis. This method enables intraoperative real-time fluorescence detection of peritoneal dissemination, exhibiting higher sensitivity than white light observation without histopathological examination. The method also enables detection of metastatic foci within excised lymph nodes, exhibiting a diagnostic accuracy comparable to that of a current molecular diagnostics technique. Although several complicating issues still need to be resolved, such as the effect of tissue autofluorescence and the insufficient depth penetration of excitation light, this simple and rapid method has the potential to become a useful diagnostic tool for gastric cancer, as well as urinary bladder cancer and glioma.

Current Evidence Regarding the Diagnostic Methods for Pediatric Lumbar Spondylolisthesis: A Report From the Scoliosis Research Society Evidence Based Medicine Committee.

PubMed

Kim, Han Jo; Crawford, Charles H; Ledonio, Charles; Bess, Shay; Larson, A Noelle; Gates, Marilyn; Oetgen, Matthew; Sanders, James O; Burton, Douglas

Structured literature review. The Scoliosis Research Society (SRS) requested an assessment of the current state of peer-reviewed evidence regarding pediatric lumbar spondylolisthesis with the goal of identifying what is known and what gaps remain in further understanding the diagnostic methods for pediatric spondylolisthesis. Spondylolisthesis in the lumbar spine is common among children and adolescents and no formal synthesis of the published literature regarding diagnostic methods has been previously performed. A comprehensive literature search was performed. Abstracts were reviewed and data from included studies were analyzed by the committee. From 6600 initial citations with abstract, 663 articles underwent full-text review. The best available evidence for the clinical questions regarding diagnostic methods was provided by 26 included studies. Six of the studies were graded as Level III (retrospective comparative), and represent the current best available evidence whereas 20 of the studies were graded as Level IV (retrospective case series) evidence. No Level V (expert opinion) studies were included in the final list. None of the studies were graded as Level I or Level II. Plain radiography is the workhorse imaging modality for diagnosing spondylolisthesis. No association between radiologic grade of spondylolisthesis and clinical presentation were noted; however, grade III and IV slips more often required surgery, and increasing slip angles were associated with worse baseline outcome scores. There is Level III evidence that the Meyerding grade appears to be more accurate for measuring slip percentage whereas the Lonstein Slip angle and Dubousset Lumbosacral Kyphosis angles are the best for measuring lumbosacral kyphosis in spondylolisthesis. In addition, higher sacral table index, pelvic incidence, sacral slope, and lower sacral table angle were associated with spondylolisthesis. True incidence could not be determined by the current literature available. However, studies in adolescent athletes demonstrated an incidence of 6% to 7% across studies. The current "best available" evidence to guide the diagnosis and characterization of pediatric spondylolisthesis is presented. Future studies are needed to provide more high-quality evidence to answer these clinically relevant questions. Level III, review of Level III studies. Copyright © 2017 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.

Diagnostic decision-making and strategies to improve diagnosis.

PubMed

Thammasitboon, Satid; Cutrer, William B

2013-10-01

A significant portion of diagnostic errors arises through cognitive errors resulting from inadequate knowledge, faulty data gathering, and/or faulty verification. Experts estimate that 75% of diagnostic failures can be attributed to clinician diagnostic thinking failure. The cognitive processes that underlie diagnostic thinking of clinicians are complex and intriguing, and it is imperative that clinicians acquire explicit appreciation and application of different cognitive approaches to make decisions better. A dual-process model that unifies many theories of decision-making has emerged as a promising template for understanding how clinicians think and judge efficiently in a diagnostic reasoning process. The identification and implementation of strategies for decreasing or preventing such diagnostic errors has become a growing area of interest and research. Suggested strategies to decrease diagnostic error incidence include increasing clinician's clinical expertise and avoiding inherent cognitive errors to make decisions better. Implementing Interventions focused solely on avoiding errors may work effectively for patient safety issues such as medication errors. Addressing cognitive errors, however, requires equal effort on expanding the individual clinician's expertise. Providing cognitive support to clinicians for robust diagnostic decision-making serves as the final strategic target for decreasing diagnostic errors. Clinical guidelines and algorithms offer another method for streamlining decision-making and decreasing likelihood of cognitive diagnostic errors. Addressing cognitive processing errors is undeniably the most challenging task in reducing diagnostic errors. While many suggested approaches exist, they are mostly based on theories and sciences in cognitive psychology, decision-making, and education. The proposed interventions are primarily suggestions and very few of them have been tested in the actual practice settings. Collaborative research effort is required to effectively address cognitive processing errors. Researchers in various areas, including patient safety/quality improvement, decision-making, and problem solving, must work together to make medical diagnosis more reliable. © 2013 Mosby, Inc. All rights reserved.

[The quality management in clinical diagnostic laboratory in conditions of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary)].

PubMed

Nikolaev, N S; Nazarova, V V; Dobrovol'skaia, N Iu; Orlova, A V; Pchelova, N N

2014-10-01

The article presents experience of clinical diagnostic laboratory of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary) in the area of quality management of medical laboratory services on the basis of evaluation of efficacy and effectiveness of processes. The factors effecting quality of functioning of clinical diagnostic laboratory are indicated. The criteria and indicators of efficacy of work of employees of clinical diagnostic laboratory are presented.

Overcoming regulatory and economic challenges facing pharmacogenomics.

PubMed

Cohen, Joshua P

2012-09-15

The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

Juvenile retinoschisis: a model for molecular diagnostic testing of X-linked ophthalmic disease.

PubMed Central

Sieving, P A; Yashar, B M; Ayyagari, R

1999-01-01

BACKGROUND AND PURPOSE: X-linked juvenile retinoschisis (RS) provides a starting point to define clinical paradigms and understand the limitations of diagnostic molecular testing. The RS phenotype is specific, but the broad severity range is clinically confusing. Molecular diagnostic testing obviates unnecessary examinations for boys at-risk and identifies carrier females who otherwise show no clinical signs. METHODS: The XLRS1 gene has 6 exons of 26-196 base-pair size. Each exon is amplified by a single polymerase chain reaction and then sequenced, starting with exons 4 through 6, which contain mutation "hot spots." RESULTS: The 6 XLRS1 exons are sequenced serially. If alterations are found, they are compared with mutations in our > 120 XLRS families and with the > 300 mutations reported worldwide. Point mutations, small deletions, or rearrangements are identified in nearly 90% of males with a clinical diagnosis of RS. XLRS1 has very few sequence polymorphisms. Carrier-state testing produces 1 of 3 results: (1) positive, in which the woman has the same mutation as an affected male relative or known in other RS families; (2) negative, in which she lacks the mutation of her affected male relative; and (3) uninformative, in which no known mutation is identified or no information exists about the familial mutation. CONCLUSIONS: Molecular RS screening is an effective diagnostic tool that complements the clinician's skills for early detection of at-risk males. Useful outcomes of carrier testing depend on several factors: (1) a male relative with a clear clinical diagnosis; (2) a well-defined inheritance pattern; (3) high disease penetrance; (4) size and organization of the gene; and (5) the types of disease-associated mutations. Ethical questions include molecular diagnostic testing of young at-risk females before the age of consent, the impact of this information on the emotional health of the patient and family, and issues of employability and insurance coverage. Images FIGURE 2A FIGURE 2B PMID:10703138

Atrophic Rhinitis of Swine

USDA-ARS?s Scientific Manuscript database

This book chapter for the 8th edition of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals describes the current state of knowledge regarding progressive atrophic rhinitis of swine. Topics covered include clinical signs and lesions, characteristics and methods of detection for...

Diagnostic quality of 50 and 100 µm computed radiography compared with screen–film mammography in operative breast specimens

PubMed Central

Pagliari, C M; Hoang, T; Reddy, M; Wilkinson, L S; Poloniecki, J D; Given-Wilson, R M

2012-01-01

Objective To compare reader ratings of the clinical diagnostic quality of 50 and 100 μm computed radiography (CR) systems with screen–film mammography (SFM) in operative specimens. Methods Mammograms of 57 fresh operative breast specimens were analysed by 10 readers. Exposures were made with identical position and compression with three mammographic systems (Fuji 100CR, 50CR and SFM). Images were anonymised and readers blinded to the CR system used. A five-point comparative scoring system (−2 to +2) was used to assess seven quality criteria and overall diagnostic value. Statistical analysis was subsequently performed of reader ratings (n=16 925). Results For most quality criteria, both CR systems were rated as equivalent to or better than SFM. The CR systems were significantly better at demonstrating skin edge and background tissue (p<1×10−5). Microcalcification was best demonstrated on the CR50 system (p<1×10−5). The overall diagnostic value of both CR systems was rated as being as good as or better than SFM (p<1×10−5). Conclusion In this clinical setting, the overall diagnostic performance of both CR systems was as good as or better than SFM, with the CR50 system performing better than the CR100. PMID:22096218

Rett Syndrome: Revised Diagnostic Criteria and Nomenclature

PubMed Central

Neul, Jeffrey L.; Kaufmann, Walter E.; Glaze, Daniel G.; Christodoulou, John; Clarke, Angus J.; Bahi-Buisson, Nadia; Leonard, Helen; Bailey, Mark E. S.; Schanen, N. Carolyn; Zappella, Michele; Renieri, Alessandra; Huppke, Peter; Percy, Alan K.

2010-01-01

Objective Rett syndrome (RTT) is a severe neurodevelopmental disease that affects approximately 1 in 10,000 live female births and is often caused by mutations in Methyl-CpG-binding protein 2 (MECP2). Despite distinct clinical features, the accumulation of clinical and molecular information in recent years has generated considerable confusion regarding the diagnosis of RTT. The purpose of this work was revise and clarify 2002 consensus criteria for the diagnosis of RTT in anticipation of treatment trials. Method RettSearch members, representing the majority of the international clinical RTT specialists, participated in an iterative process to come to a consensus on a revised and simplified clinical diagnostic criteria for RTT. Results The clinical criteria required for the diagnosis of classic and atypical RTT were clarified and simplified. Guidelines for the diagnosis and molecular evaluation of specific variant forms of RTT were developed. Interpretation These revised criteria provide clarity regarding the key features required for the diagnosis of RTT and reinforce the concept that RTT is a clinical diagnosis based on distinct clinical criteria, independent of molecular findings. We recommend that these criteria and guidelines be utilized in any proposed clinical research. PMID:21154482

Socio-demographic and academic correlates of clinical reasoning in a dental school in South Africa.

PubMed

Postma, T C; White, J G

2017-02-01

There are no empirical studies that describe factors that may influence the development of integrated clinical reasoning skills in dental education. Hence, this study examines the association between outcomes of clinical reasoning in relation with differences in instructional design and student factors. Progress test scores, including diagnostic and treatment planning scores, of fourth and fifth year dental students (2009-2011) at the University of Pretoria, South Africa served as the outcome measures in stepwise linear regression analyses. These scores were correlated with the instructional design (lecture-based teaching and learning (LBTL = 0) or case-based teaching and learning (CBTL = 1), students' grades in Oral Biology, indicators of socio-economic status (SES) and gender. CBTL showed an independent association with progress test scores. Oral Biology scores correlated with diagnostic component scores. Diagnostic component scores correlated with treatment planning scores in the fourth year of study but not in the fifth year of study. 'SES' correlated with progress test scores in year five only, while gender showed no correlation. The empirical evidence gathered in this study provides support for scaffolded inductive teaching and learning methods to develop clinical reasoning skills. Knowledge in Oral Biology and reading skills may be important attributes to develop to ensure that students are able to reason accurately in a clinical setting. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Description of the mental processes occurring during clinical reasoning].

PubMed

Pottier, P; Planchon, B

2011-06-01

Clinical reasoning is a highly complex system with multiple inter-dependent mental activities. Gaining a better understanding of those cognitive processes has two practical implications: for physicians, being able to analyse their own reasoning method may prove to be helpful in diagnostic dead end; for medical teachers, identifying problem-solving strategies used by medical students may foster an appropriate individual feed-back aiming at improving their clinical reasoning skills. On the basis of a detailed literature review, the main diagnostic strategies and their related pattern of mental processes are described and illustrated with a concrete example, going from the patient's complaint to the chosen solution. Inductive, abductive and deductive diagnostic approaches are detailed. Different strategies for collecting data (exhaustive or oriented) and for problem-building are described. The place of problem solving strategies such as pattern-recognition, scheme inductive process, using of clinical script, syndrome grouping and mental hypotheses test is considered. This work aims at breaking up mental activities in process within clinical reasoning reminding that expert reasoning is characterised by the ability to use and structure the whole of these activities in a coherent system, using combined strategies in order to guarantee a better accuracy of their diagnosis. Copyright © 2010 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.

Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: a pragmatic approach.

PubMed

Antonelli, Giorgia; Padoan, Andrea; Aita, Ada; Sciacovelli, Laura; Plebani, Mario

2017-08-28

Background The International Standard ISO 15189 is recognized as a valuable guide in ensuring high quality clinical laboratory services and promoting the harmonization of accreditation programmes in laboratory medicine. Examination procedures must be verified in order to guarantee that their performance characteristics are congruent with the intended scope of the test. The aim of the present study was to propose a practice model for implementing procedures employed for the verification of validated examination procedures already used for at least 2 years in our laboratory, in agreement with the ISO 15189 requirement at the Section 5.5.1.2. Methods In order to identify the operative procedure to be used, approved documents were identified, together with the definition of performance characteristics to be evaluated for the different methods; the examination procedures used in laboratory were analyzed and checked for performance specifications reported by manufacturers. Then, operative flow charts were identified to compare the laboratory performance characteristics with those declared by manufacturers. Results The choice of performance characteristics for verification was based on approved documents used as guidance, and the specific purpose tests undertaken, a consideration being made of: imprecision and trueness for quantitative methods; diagnostic accuracy for qualitative methods; imprecision together with diagnostic accuracy for semi-quantitative methods. Conclusions The described approach, balancing technological possibilities, risks and costs and assuring the compliance of the fundamental component of result accuracy, appears promising as an easily applicable and flexible procedure helping laboratories to comply with the ISO 15189 requirements.

Medicalising normality? Using a simulated dataset to assess the performance of different diagnostic criteria of HIV-associated cognitive impairment

PubMed Central

De Francesco, Davide; Leech, Robert; Sabin, Caroline A.; Winston, Alan

2018-01-01

Objective The reported prevalence of cognitive impairment remains similar to that reported in the pre-antiretroviral therapy era. This may be partially artefactual due to the methods used to diagnose impairment. In this study, we evaluated the diagnostic performance of the HIV-associated neurocognitive disorder (Frascati criteria) and global deficit score (GDS) methods in comparison to a new, multivariate method of diagnosis. Methods Using a simulated ‘normative’ dataset informed by real-world cognitive data from the observational Pharmacokinetic and Clinical Observations in PeoPle Over fiftY (POPPY) cohort study, we evaluated the apparent prevalence of cognitive impairment using the Frascati and GDS definitions, as well as a novel multivariate method based on the Mahalanobis distance. We then quantified the diagnostic properties (including positive and negative predictive values and accuracy) of each method, using bootstrapping with 10,000 replicates, with a separate ‘test’ dataset to which a pre-defined proportion of ‘impaired’ individuals had been added. Results The simulated normative dataset demonstrated that up to ~26% of a normative control population would be diagnosed with cognitive impairment with the Frascati criteria and ~20% with the GDS. In contrast, the multivariate Mahalanobis distance method identified impairment in ~5%. Using the test dataset, diagnostic accuracy [95% confidence intervals] and positive predictive value (PPV) was best for the multivariate method vs. Frascati and GDS (accuracy: 92.8% [90.3–95.2%] vs. 76.1% [72.1–80.0%] and 80.6% [76.6–84.5%] respectively; PPV: 61.2% [48.3–72.2%] vs. 29.4% [22.2–36.8%] and 33.9% [25.6–42.3%] respectively). Increasing the a priori false positive rate for the multivariate Mahalanobis distance method from 5% to 15% resulted in an increase in sensitivity from 77.4% (64.5–89.4%) to 92.2% (83.3–100%) at a cost of specificity from 94.5% (92.8–95.2%) to 85.0% (81.2–88.5%). Conclusion Our simulations suggest that the commonly used diagnostic criteria of HIV-associated cognitive impairment label a significant proportion of a normative reference population as cognitively impaired, which will likely lead to a substantial over-estimate of the true proportion in a study population, due to their lower than expected specificity. These findings have important implications for clinical research regarding cognitive health in people living with HIV. More accurate methods of diagnosis should be implemented, with multivariate techniques offering a promising solution. PMID:29641619

Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders.

PubMed

Mashamba-Thompson, Tivani P; Jama, Ngcwalisa A; Sartorius, Benn; Drain, Paul K; Thompson, Rowan M

2017-01-08

Key stakeholders' involvement is crucial to the sustainability of quality point-of-care (POC) diagnostics services in low-and-middle income countries. The aim of this study was to explore key stakeholder perceptions on the implementation of POC diagnostics in rural primary healthcare (PHC) clinics in South Africa. We conducted a qualitative study encompassing in-depth interviews with multiple key stakeholders of POC diagnostic services for rural and resource-limited PHC clinics. Interviews were digitally recorded and transcribed verbatim prior to thematic content analysis. Thematic content analysis was conducted using themes guided by the World Health Organisation (WHO) quality-ASSURED (Affordable, Sensitive, Specific, User friendly, Rapid and to enable treatment at first visit and Robust, Equipment free and Delivered to those who need it) criteria for POC diagnostic services in resource-limited settings. 11 key stakeholders participated in the study. All stakeholders perceived the main advantage of POC diagnostics as enabling access to healthcare for rural patients. Stakeholders perceived the current POC diagnostic services to have an ability to meet patients' needs, but recommended further improvement of the following areas: research on cost-effectiveness; improved quality management systems; development of affordable POC diagnostic and clinic-based monitoring and evaluation. Key stakeholders of POC diagnostics in rural PHC clinics in South Africa highlighted the need to assess affordability and ensure quality assurance of current services before adopting new POC diagnostics and scaling up current POC diagnostics.

The Importance of Conditional Probability in Diagnostic Reasoning and Clinical Decision Making: A Primer for the Eye Care Practitioner.

PubMed

Sanfilippo, Paul G; Hewitt, Alex W; Mackey, David A

2017-04-01

To outline and detail the importance of conditional probability in clinical decision making and discuss the various diagnostic measures eye care practitioners should be aware of in order to improve the scope of their clinical practice. We conducted a review of the importance of conditional probability in diagnostic testing for the eye care practitioner. Eye care practitioners use diagnostic tests on a daily basis to assist in clinical decision making and optimizing patient care and management. These tests provide probabilistic information that can enable the clinician to increase (or decrease) their level of certainty about the presence of a particular condition. While an understanding of the characteristics of diagnostic tests are essential to facilitate proper interpretation of test results and disease risk, many practitioners either confuse or misinterpret these measures. In the interests of their patients, practitioners should be aware of the basic concepts associated with diagnostic testing and the simple mathematical rule that underpins them. Importantly, the practitioner needs to recognize that the prevalence of a disease in the population greatly determines the clinical value of a diagnostic test.

Evaluating Diagnostic Point-of-Care Tests in Resource-Limited Settings

PubMed Central

Drain, Paul K; Hyle, Emily P; Noubary, Farzad; Freedberg, Kenneth A; Wilson, Douglas; Bishai, William; Rodriguez, William; Bassett, Ingrid V

2014-01-01

Diagnostic point-of-care (POC) testing is intended to minimize the time to obtain a test result, thereby allowing clinicians and patients to make an expeditious clinical decision. As POC tests expand into resource-limited settings (RLS), the benefits must outweigh the costs. To optimize POC testing in RLS, diagnostic POC tests need rigorous evaluations focused on relevant clinical outcomes and operational costs, which differ from evaluations of conventional diagnostic tests. Here, we reviewed published studies on POC testing in RLS, and found no clearly defined metric for the clinical utility of POC testing. Therefore, we propose a framework for evaluating POC tests, and suggest and define the term “test efficacy” to describe a diagnostic test’s capacity to support a clinical decision within its operational context. We also proposed revised criteria for an ideal diagnostic POC test in resource-limited settings. Through systematic evaluations, comparisons between centralized diagnostic testing and novel POC technologies can be more formalized, and health officials can better determine which POC technologies represent valuable additions to their clinical programs. PMID:24332389

Implementation of HIV and Tuberculosis Diagnostics: The Importance of Context

PubMed Central

Dominique, Joyelle K.; Ortiz-Osorno, Alberto A.; Fitzgibbon, Joseph; Gnanashanmugam, Devasena; Gilpin, Christopher; Tucker, Timothy; Peel, Sheila; Peter, Trevor; Kim, Peter; Smith, Steven

2015-01-01

Background. Novel diagnostics have been widely applied across human immunodeficiency virus (HIV) and tuberculosis prevention and treatment programs. To achieve the greatest impact, HIV and tuberculosis diagnostic programs must carefully plan and implement within the context of a specific healthcare system and the laboratory capacity. Methods. A workshop was convened in Cape Town in September 2014. Participants included experts from laboratory and clinical practices, officials from ministries of health, and representatives from industry. Results. The article summarizes best practices, challenges, and lessons learned from implementation experiences across sub-Saharan Africa for (1) building laboratory programs within the context of a healthcare system; (2) utilizing experience of clinicians and healthcare partners in planning and implementing the right diagnostic; and (3) evaluating the effects of new diagnostics on the healthcare system and on patient health outcomes. Conclusions. The successful implementation of HIV and tuberculosis diagnostics in resource-limited settings relies on careful consideration of each specific context. PMID:26409272

A systematic review of diagnostic criteria for psoriasis in adults and children: evidence from studies with a primary aim to develop or validate diagnostic criteria.

PubMed

Burden-Teh, E; Phillips, R C; Thomas, K S; Ratib, S; Grindlay, D; Murphy, R

2017-11-06

The diagnosis of psoriasis in adults and children is made clinically, for both patient management and the selection of participants in research. Diagnostic criteria provide a structure for clinical assessment, which in turn helps standardize patient recruitment into clinical trials and case definitions in observational studies. The aim of this systematic review was to identify and critically appraise the published studies to date that had a primary research aim to develop or validate diagnostic criteria for psoriasis. A search of Ovid MEDLINE and Ovid Embase was conducted in October 2016. The primary objective was to record the sensitivity and specificity of diagnostic criteria for psoriasis. Secondary objectives included diagnostic recommendations, applicability to children and study characteristics. Diagnostic accuracy studies were critically appraised for risk of bias using the QUADAS-2 tool. Twenty-three studies met the inclusion criteria. None detailed clinical examination-based diagnostic criteria. The included criteria varied from genetic and molecular diagnostic models to skin imaging, histopathology, and questionnaire-based, computer-aided and traditional Chinese medicine criteria. High sensitivity and specificity (> 90%) were reported in many studies. However, the study authors often did not specify how the criteria would be used clinically or in research. This review identified studies with varying risk of bias, and due to each study developing separate criteria meta-analysis was not possible. Clinical examination-based diagnostic criteria are currently lacking for psoriasis. Future research could follow an international collaborative approach and employ study designs allowing high-quality diagnostic accuracy testing. Existing and newly developed criteria require validation. © 2017 British Association of Dermatologists.

A bioinformatics approach to identify patients with symptomatic peanut allergy using peptide microarray immunoassay

PubMed Central

Lin, Jing; Bruni, Francesca M.; Fu, Zhiyan; Maloney, Jennifer; Bardina, Ludmilla; Boner, Attilio L.; Gimenez, Gustavo; Sampson, Hugh A.

2013-01-01

Background Peanut allergy is relatively common, typically permanent, and often severe. Double-blind, placebo-controlled food challenge is considered the gold standard for the diagnosis of food allergy–related disorders. However, the complexity and potential of double-blind, placebo-controlled food challenge to cause life-threatening allergic reactions affects its clinical application. A laboratory test that could accurately diagnose symptomatic peanut allergy would greatly facilitate clinical practice. Objective We sought to develop an allergy diagnostic method that could correctly predict symptomatic peanut allergy by using peptide microarray immunoassays and bioinformatic methods. Methods Microarray immunoassays were performed by using the sera from 62 patients (31 with symptomatic peanut allergy and 31 who had outgrown their peanut allergy or were sensitized but were clinically tolerant to peanut). Specific IgE and IgG4 binding to 419 overlapping peptides (15 mers, 3 offset) covering the amino acid sequences of Ara h 1, Ara h 2, and Ara h 3 were measured by using a peptide microarray immunoassay. Bioinformatic methods were applied for data analysis. Results Individuals with peanut allergy showed significantly greater IgE binding and broader epitope diversity than did peanut-tolerant individuals. No significant difference in IgG4 binding was found between groups. By using machine learning methods, 4 peptide biomarkers were identified and prediction models that can predict the outcome of double-blind, placebo-controlled food challenges with high accuracy were developed by using a combination of the biomarkers. Conclusions In this study, we developed a novel diagnostic approach that can predict peanut allergy with high accuracy by combining the results of a peptide microarray immunoassay and bioinformatic methods. Further studies are needed to validate the efficacy of this assay in clinical practice. PMID:22444503

Optimization of OSEM parameters in myocardial perfusion imaging reconstruction as a function of body mass index: a clinical approach*

PubMed Central

de Barros, Pietro Paolo; Metello, Luis F.; Camozzato, Tatiane Sabriela Cagol; Vieira, Domingos Manuel da Silva

2015-01-01

Objective The present study is aimed at contributing to identify the most appropriate OSEM parameters to generate myocardial perfusion imaging reconstructions with the best diagnostic quality, correlating them with patients’ body mass index. Materials and Methods The present study included 28 adult patients submitted to myocardial perfusion imaging in a public hospital. The OSEM method was utilized in the images reconstruction with six different combinations of iterations and subsets numbers. The images were analyzed by nuclear cardiology specialists taking their diagnostic value into consideration and indicating the most appropriate images in terms of diagnostic quality. Results An overall scoring analysis demonstrated that the combination of four iterations and four subsets has generated the most appropriate images in terms of diagnostic quality for all the classes of body mass index; however, the role played by the combination of six iterations and four subsets is highlighted in relation to the higher body mass index classes. Conclusion The use of optimized parameters seems to play a relevant role in the generation of images with better diagnostic quality, ensuring the diagnosis and consequential appropriate and effective treatment for the patient. PMID:26543282

Detection of Intestinal Protozoa in the Clinical Laboratory

PubMed Central

McHardy, Ian H.; Wu, Max; Shimizu-Cohen, Robyn; Couturier, Marc Roger

2014-01-01

Despite recent advances in diagnostic technology, microscopic examination of stool specimens remains central to the diagnosis of most pathogenic intestinal protozoa. Microscopy is, however, labor-intensive and requires a skilled technologist. New, highly sensitive diagnostic methods have been developed for protozoa endemic to developed countries, including Giardia lamblia (syn. G. intestinalis/G. duodenalis) and Cryptosporidium spp., using technologies that, if expanded, could effectively complement or even replace microscopic approaches. To date, the scope of such novel technologies is limited and may not include common protozoa such as Dientamoeba fragilis, Entamoeba histolytica, or Cyclospora cayetanensis. This minireview describes canonical approaches for the detection of pathogenic intestinal protozoa, while highlighting recent developments and FDA-approved tools for clinical diagnosis of common intestinal protozoa. PMID:24197877

Detection of intestinal protozoa in the clinical laboratory.

PubMed

McHardy, Ian H; Wu, Max; Shimizu-Cohen, Robyn; Couturier, Marc Roger; Humphries, Romney M

2014-03-01

Despite recent advances in diagnostic technology, microscopic examination of stool specimens remains central to the diagnosis of most pathogenic intestinal protozoa. Microscopy is, however, labor-intensive and requires a skilled technologist. New, highly sensitive diagnostic methods have been developed for protozoa endemic to developed countries, including Giardia lamblia (syn. G. intestinalis/G. duodenalis) and Cryptosporidium spp., using technologies that, if expanded, could effectively complement or even replace microscopic approaches. To date, the scope of such novel technologies is limited and may not include common protozoa such as Dientamoeba fragilis, Entamoeba histolytica, or Cyclospora cayetanensis. This minireview describes canonical approaches for the detection of pathogenic intestinal protozoa, while highlighting recent developments and FDA-approved tools for clinical diagnosis of common intestinal protozoa.

[Acute hepatitis in infectious diseases].

PubMed

Podymova, S D

2013-01-01

Hepatitis A, B, C, D, E, G are the most common causes of acute hepatitis, however, there are many infectious diseases affecting liver and with fever, early diagnostics of which is very important for the clinic of internal diseases. This review presents infections, causing fever and hepatitis, but not necessarily accompanied by jaundice. Leptospirosis, yellow fever have been considered, in which liver damage determines the clinic and the prognosis of the disease. In other cases, such as infectious mononucleosis, cytomegalovirus and herpetic hepatitis, typho-para-typhoid infections, typhoid, pneumonia, some viral diseases, malaria, Legionnaire's disease, hepatitis do not have their independent status and represent one of the important syndromes of a common disease. Modern methods of diagnostics and treatment of these diseases have been described.

Controlling the Display of Capsule Endoscopy Video for Diagnostic Assistance

NASA Astrophysics Data System (ADS)

Vu, Hai; Echigo, Tomio; Sagawa, Ryusuke; Yagi, Keiko; Shiba, Masatsugu; Higuchi, Kazuhide; Arakawa, Tetsuo; Yagi, Yasushi

Interpretations by physicians of capsule endoscopy image sequences captured over periods of 7-8 hours usually require 45 to 120 minutes of extreme concentration. This paper describes a novel method to reduce diagnostic time by automatically controlling the display frame rate. Unlike existing techniques, this method displays original images with no skipping of frames. The sequence can be played at a high frame rate in stable regions to save time. Then, in regions with rough changes, the speed is decreased to more conveniently ascertain suspicious findings. To realize such a system, cue information about the disparity of consecutive frames, including color similarity and motion displacements is extracted. A decision tree utilizes these features to classify the states of the image acquisitions. For each classified state, the delay time between frames is calculated by parametric functions. A scheme selecting the optimal parameters set determined from assessments by physicians is deployed. Experiments involved clinical evaluations to investigate the effectiveness of this method compared to a standard-view using an existing system. Results from logged action based analysis show that compared with an existing system the proposed method reduced diagnostic time to around 32.5 ± minutes per full sequence while the number of abnormalities found was similar. As well, physicians needed less effort because of the systems efficient operability. The results of the evaluations should convince physicians that they can safely use this method and obtain reduced diagnostic times.

Requirements for diagnosis of malaria at different levels of the laboratory network in Africa.

PubMed

Long, Earl G

2009-06-01

The rapid increase of resistance to cheap, reliable antimalarials, the increasing cost of effective drugs, and the low specificity of clinical diagnosis has increased the need for more reliable diagnostic methods for malaria. The most commonly used and most reliable remains microscopic examination of stained blood smears, but this technique requires skilled personnel, precision instruments, and ideally a source of electricity. Microscopy has the advantage of enabling the examiner to identify the species, stage, and density of an infection. An alternative to microscopy is the rapid diagnostic test (RDT), which uses a labeled monoclonal antibody to detect circulating parasitic antigens. This test is most commonly used to detect Plasmodium falciparum infections and is available in a plastic cassette format. Both microscopy and RDTs should be available at all levels of laboratory service in endemic areas, but in peripheral laboratories with minimally trained staff, the RDT may be a more practical diagnostic method.

The diagnostic accuracy of dermoscopy for scabies.

PubMed

Park, Ju Hyuk; Kim, Chul Woo; Kim, Sang Seok

2012-05-01

Scabies is a contagious skin infestation characterized clinically by nocturnal pruritus, visible burrows and contagiousness. Dermoscopy has been suggested as an alternative for diagnosing scabies. But, there have been few well-designed studies evaluating the diagnostic accuracy of dermoscopy. We tried to confirm the diagnostic accuracy of dermoscopy for diagnosing scabies. We also tried to demonstrate specific circumstances in which dermoscopic identification of mites ("with dermoscopy") is more useful in diagnosing scabies, and to identify the specific clinical findings that could be used as a possible marker in diagnosing scabies. We compared the scraping procedure "with dermoscopy" and "without it" in 49 patients, measuring the duration and outcome of each procedure. Also, we tried to find the specific clinical factors associated with our objects. The skin scraping "with dermoscopy" was superior to "without it" with respect to the duration and accuracy of the procedure. A history of previous steroid treatment was associated with the superiority of dermoscopy. The correlation between the presence of visible burrows and the positive outcomes of "with dermoscopy" was statistically significant. Skin scraping with dermoscopy is implicated as the diagnostic method of choice for scabies at the present time. Dermoscopy is especially useful in diagnosis of incognito scabies. In addition, the presence of visible burrows could be a reliable positive marker of scabies in the absence of dermoscopy or microscopy data.

Evaluating the diagnostic accuracy of the Xpert MTB/RIF assay on bronchoalveolar lavage fluid: A retrospective study.

PubMed

Lu, Yanjun; Zhu, Yaowu; Shen, Na; Tian, Lei; Sun, Ziyong

2018-02-08

Limited data on the diagnostic accuracy of the Xpert MTB/RIF assay using bronchoalveolar lavage fluid from patients with suspected pulmonary tuberculosis (PTB) have been reported in China. Therefore, a retrospective study was designed to evaluate the diagnostic accuracy of this assay. Clinical, radiological, and microbiological characteristics of 238 patients with suspected PTB were reviewed retrospectively. The sensitivity, specificity, positive predictive value, and negative predictive value for the diagnosis of active PTB were calculated for the Xpert MTB/RIF assay using TB culture or final diagnosis based on clinical and radiological evaluation as the reference standard. The sensitivity and specificity of the Xpert MTB/RIF assay were 84.5% and 98.9%, respectively, and those for smear microscopy were 36.2% and 100%, respectively, when compared to the culture method. However, compared with the sensitivity and specificity of final diagnosis based on clinical and radiological evaluation, the sensitivity and specificity of the assay were 72.9% and 98.7%, respectively, which were significantly higher than those for smear microscopy. The Xpert MTB/RIF assay on bronchoalveolar lavage fluid could serve as an additional rapid diagnostic tool for PTB in a high TB-burden country and improve the time to TB treatment initiation in patients with PTB. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Systematic review of the diagnosis of scabies in therapeutic trials.

PubMed

Thompson, M J; Engelman, D; Gholam, K; Fuller, L C; Steer, A C

2017-07-01

Human scabies (infestation with the mite Sarcoptes scabiei var hominis) causes a significant disease burden worldwide, yet there are no agreed diagnostic guidelines. We aimed to determine whether a consistent approach to diagnosing scabies has been used for published scabies therapeutic trials. The data sources used were the MEDLINE, Embase and Cochrane databases, from 1946 to 29 August 2013. Eligible studies were trials of therapeutic interventions against scabies in human subjects, published in English, enrolling patients with scabies, and using various therapeutic interventions. Language was a limitation of this study as some relevant trials published in languages other than English may have been excluded. Each study was reviewed by two independent authors, who assessed the clinical examination and testing approaches used for scabies diagnosis in the included studies. We found that of 71 included trials, 40 (56%) specified which clinical findings were used for diagnosis, which were predominantly rash, rash distribution, pruritus and mite burrows. Parasitological testing was used in 63% of trials (n = 45) and was used more frequently in clinic-based than in field studies. Nearly one-quarter of trials (24%, n = 17) did not define the diagnostic method used. Overall, the diagnostic approaches were poorly described, prohibiting accurate comparison of existing studies. This review further supports the need for consensus diagnostic guidelines for scabies. © 2017 British Association of Dermatologists.

Molecular pathology curriculum for medical laboratory scientists: A report of the association for molecular pathology training and education committee.

PubMed

Taylor, Sara; Bennett, Katie M; Deignan, Joshua L; Hendrix, Ericka C; Orton, Susan M; Verma, Shalini; Schutzbank, Ted E

2014-05-01

Molecular diagnostics is a rapidly growing specialty in the clinical laboratory assessment of pathology. Educational programs in medical laboratory science and specialized programs in molecular diagnostics must address the training of clinical scientists in molecular diagnostics, but the educational curriculum for this field is not well defined. Moreover, our understanding of underlying genetic contributions to specific diseases and the technologies used in molecular diagnostics laboratories change rapidly, challenging providers of training programs in molecular diagnostics to keep their curriculum current and relevant. In this article, we provide curriculum recommendations to molecular diagnostics training providers at both the baccalaureate and master's level of education. We base our recommendations on several factors. First, we considered National Accrediting Agency for Clinical Laboratory Sciences guidelines for accreditation of molecular diagnostics programs, because educational programs in clinical laboratory science should obtain its accreditation. Second, the guidelines of several of the best known certifying agencies for clinical laboratory scientists were incorporated into our recommendations. Finally, we relied on feedback from current employers of molecular diagnostics scientists, regarding the skills and knowledge that they believe are essential for clinical scientists who will be performing molecular testing in their laboratories. We have compiled these data into recommendations for a molecular diagnostics curriculum at both the baccalaureate and master's level of education. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Decision analysis to complete diagnostic research by closing the gap between test characteristics and cost-effectiveness.

PubMed

Schaafsma, Joanna D; van der Graaf, Yolanda; Rinkel, Gabriel J E; Buskens, Erik

2009-12-01

The lack of a standard methodology in diagnostic research impedes adequate evaluation before implementation of constantly developing diagnostic techniques. We discuss the methodology of diagnostic research and underscore the relevance of decision analysis in the process of evaluation of diagnostic tests. Overview and conceptual discussion. Diagnostic research requires a stepwise approach comprising assessment of test characteristics followed by evaluation of added value, clinical outcome, and cost-effectiveness. These multiple goals are generally incompatible with a randomized design. Decision-analytic models provide an important alternative through integration of the best available evidence. Thus, critical assessment of clinical value and efficient use of resources can be achieved. Decision-analytic models should be considered part of the standard methodology in diagnostic research. They can serve as a valid alternative to diagnostic randomized clinical trials (RCTs).

Clinical Diagnosis of Dental Caries in the 21st Century: Introductory Paper - ORCA Saturday Afternoon Symposium, 2016.

PubMed

Machiulskiene, Vita; Carvalho, Joana Christina

2018-03-05

Classifications employed to measure dental caries should first of all reflect the dynamics of the disease, in order to provide a solid basis for subsequent treatment decisions and for further monitoring of dental health of individual patients and populations. The contemporary philosophy of dental caries management implies that nonoperative treatment of caries lesions should be implemented whenever possible, limiting operative interventions to the severe and irreversible cases. The ORCA Saturday Afternoon Symposium 2016, held back-to-back to the 63rd ORCA Congress in Athens, Greece, was intended to provide an update on general requirements for clinical caries diagnosis and to overview caries diagnostic classifications including their rationale, validation, advantages, and limitations. Clinical caries diagnostic criteria and caries management outcomes are interrelated, and any diagnostic classification disregarding this concept is outdated, according to the current understanding of oral health care. Choosing clinical caries diagnostic classifications that assess the activity status of detected lesions should be a priority for dental professionals since these classifications favor the best clinical practice directed towards nonoperative interventions. The choice of clinical caries diagnostic classifications in research, in clinical practice, and in public health services should be guided by the best available scientific evidence. The clinical caries diagnostic classifications should be universally applicable in all these fields. Policy making in oral health care and the underlying policy analyses should follow the same standards. Any clinical caries diagnostic classification disregarding the universality of its use is of limited or no interest in the context of the clinical caries diagnosis of today. © 2018 S. Karger AG, Basel.

Clinical Management and Use of Health Care Resources in the Treatment of Nasal Polyposis in Spanish Allergy Centers: The POLAR Study.

PubMed

Rondón, C; Dávila, I; Navarro Pulido, A M; Sánchez, M C; Montoro, J; Matheu, V; Lluch-Bernal, M; Fernández-Parra, B; Ibáñez, M D; Dordal, M T; Colás, C; Antón, E; Valero, A

2015-01-01

Nasal polyposis (NP) is a chronic inflammatory disease that constitutes a major health problem with significant comorbidities and a considerable associated socioeconomic burden. To describe the clinical features and management of patients with NP attending Spanish allergy centers, the use of health care resources, and the degree of compliance with the diagnostic and therapeutic recommendations of the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS). We performed a multicenter, observational, and cross-sectional epidemiologic study of 671 patients consulting for NP in 67 Spanish allergy departments. We used sociodemographic and clinical questionnaires to evaluate clinical characteristics, use of health care resources, diagnostic methods, and treatment administered. NP was closely associated with asthma (66%), allergic rhinitis (45.9%), and hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) (26%). Atopy was present in the 50% of cases, with Dermatophagoides pteronyssinus as the most frequent sensitizing allergen. Eleven percent of NP patients visited the emergency department during the previous year, and more than 58% used primary care, allergy, or otorhinolaryngology services. The most frequently used diagnostic tests were skin prick tests (93.6%) and anterior rhinoscopy (79.4%). Intranasal corticosteroids were the drug class most frequently prescribed by allergists (74.6%). Specific immunotherapy was prescribed in 21% of patients. NP is a chronic inflammatory disease that generates considerable use of health care resources. The close association with atopy, asthma, and NSAID hypersensitivity highlights the usefulness of an allergy workup in all patients with NP. Analysis of the clinical management of NP by allergists in Spain revealed a high degree of compliance with EPOS diagnostic and therapeutic recommendations.

An Empirically Derived Taxonomy for Personality Diagnosis: Bridging Science and Practice in Conceptualizing Personality

PubMed Central

Westen, Drew; Shedler, Jonathan; Bradley, Bekh; DeFife, Jared A.

2013-01-01

Objective The authors describe a system for diagnosing personality pathology that is empirically derived, clinically relevant, and practical for day-to-day use. Method A random national sample of psychiatrists and clinical psychologists (N=1,201) described a randomly selected current patient with any degree of personality dysfunction (from minimal to severe) using the descriptors in the Shedler-Westen Assessment Procedure–II and completed additional research forms. Results The authors applied factor analysis to identify naturally occurring diagnostic groupings within the patient sample. The analysis yielded 10 clinically coherent personality diagnoses organized into three higher-order clusters: internalizing, externalizing, and borderline-dysregulated. The authors selected the most highly rated descriptors to construct a diagnostic prototype for each personality syndrome. In a second, independent sample, research interviewers and patients’ treating clinicians were able to diagnose the personality syndromes with high agreement and minimal comorbidity among diagnoses. Conclusions The empirically derived personality prototypes described here provide a framework for personality diagnosis that is both empirically based and clinically relevant. PMID:22193534

[Computer-assisted phonetography as a diagnostic aid in functional dysphonia].

PubMed

Airainer, R; Klingholz, F

1991-07-01

A total of 160 voice-trained and untrained subjects with functional dysphonia were given a "clinical rating" according to their clinical findings. This was a certain value on a scale that recorded the degree of functional voice disorder ranging from a marked hypofunction to an extreme hyperfunction. The phonetograms of these patients were approximated by ellipses, whereby the definition and quantitative recording of several phonetogram parameters were rendered possible. By means of a linear combination of phonetogram parameters, a "calculated assessment" was obtained for each patient that was expected to tally with the "clinical rating". This paper demonstrates that a graduation of the dysphonic clinical picture with regard to the presence of hypofunctional or hyperfunctional components is possible via computerised phonetogram evaluation. In this case, the "calculated assessments" for both male and female singers and non-singers must be computed using different linear combinations. The method can be introduced as a supplementary diagnostic procedure in the diagnosis of functional dysphonia.

Congenital syphilis in the 21st century.

PubMed

Rodríguez-Cerdeira, C; Silami-Lopes, V G

2012-10-01

While the prevalence of congenital syphilis continues to be low throughout most of the developed world, there has been a slight resurgence of the disease in several European countries, including Spain. In this context, we need to become more familiar with the signs and symptoms of this disease and consider its diagnosis in patients with only mild clinical manifestations. A definitive diagnosis may be difficult or even impossible in patients whose diagnostic tests reveal low positive titers or inconsistent results. The cornerstone of congenital syphilis control is prenatal screening and the treatment of infected mothers with penicillin, an effective and economical intervention. Based on a review of the literature supplemented by data from our own clinical experience, this article provides a detailed description of the clinical manifestations of congenital syphilis as well as the various diagnostic methods and treatments available. Copyright © 2011 Elsevier España, S.L. y AEDV. All rights reserved.

Clinical Application of Genome and Exome Sequencing as a Diagnostic Tool for Pediatric Patients: a Scoping Review of the Literature.

PubMed

Smith, Hadley Stevens; Swint, J Michael; Lalani, Seema R; Yamal, Jose-Miguel; de Oliveira Otto, Marcia C; Castellanos, Stephan; Taylor, Amy; Lee, Brendan H; Russell, Heidi V

2018-05-14

Availability of clinical genomic sequencing (CGS) has generated questions about the value of genome and exome sequencing as a diagnostic tool. Analysis of reported CGS application can inform uptake and direct further research. This scoping literature review aims to synthesize evidence on the clinical and economic impact of CGS. PubMed, Embase, and Cochrane were searched for peer-reviewed articles published between 2009 and 2017 on diagnostic CGS for infant and pediatric patients. Articles were classified according to sample size and whether economic evaluation was a primary research objective. Data on patient characteristics, clinical setting, and outcomes were extracted and narratively synthesized. Of 171 included articles, 131 were case reports, 40 were aggregate analyses, and 4 had a primary economic evaluation aim. Diagnostic yield was the only consistently reported outcome. Median diagnostic yield in aggregate analyses was 33.2% but varied by broad clinical categories and test type. Reported CGS use has rapidly increased and spans diverse clinical settings and patient phenotypes. Economic evaluations support the cost-saving potential of diagnostic CGS. Multidisciplinary implementation research, including more robust outcome measurement and economic evaluation, is needed to demonstrate clinical utility and cost-effectiveness of CGS.

Development of an integrated Sasang constitution diagnosis method using face, body shape, voice, and questionnaire information.

PubMed

Do, Jun-Hyeong; Jang, Eunsu; Ku, Boncho; Jang, Jun-Su; Kim, Honggie; Kim, Jong Yeol

2012-07-04

Sasang constitutional medicine (SCM) is a unique form of traditional Korean medicine that divides human beings into four constitutional types (Tae-Yang: TY, Tae-Eum: TE, So-Yang: SY, and So-Eum: SE), which differ in inherited characteristics, such as external appearance, personality traits, susceptibility to particular diseases, drug responses, and equilibrium among internal organ functions. According to SCM, herbs that belong to a certain constitution cannot be used in patients with other constitutions; otherwise, this practice may result in no effect or in an adverse effect. Thus, the diagnosis of SC type is the most crucial step in SCM practice. The diagnosis, however, tends to be subjective due to a lack of quantitative standards for SC diagnosis. We have attempted to make the diagnosis method as objective as possible by basing it on an analysis of quantitative data from various Oriental medical clinics. Four individual diagnostic models were developed with multinomial logistic regression based on face, body shape, voice, and questionnaire responses. Inspired by SCM practitioners' holistic diagnostic processes, an integrated diagnostic model was then proposed by combining the four individual models. The diagnostic accuracies in the test set, after the four individual models had been integrated into a single model, improved to 64.0% and 55.2% in the male and female patient groups, respectively. Using a cut-off value for the integrated SC score, such as 1.6, the accuracies increased by 14.7% in male patients and by 4.6% in female patients, which showed that a higher integrated SC score corresponded to a higher diagnostic accuracy. This study represents the first trial of integrating the objectification of SC diagnosis based on quantitative data and SCM practitioners' holistic diagnostic processes. Although the diagnostic accuracy was not great, it is noted that the proposed diagnostic model represents common rules among practitioners who have various points of view. Our results are expected to contribute as a desirable research guide for objective diagnosis in traditional medicine, as well as to contribute to the precise diagnosis of SC types in an objective manner in clinical practice.

[Mass spectrometry in the clinical microbiology laboratory].

PubMed

Jordana-Lluch, Elena; Martró Català, Elisa; Ausina Ruiz, Vicente

2012-12-01

Infectious diseases are still a cause of high mortality and morbidity rates. Current microbiological diagnostic methods are based on culture and phenotypic identification of isolated microorganisms, which can be obtained in about 24-48 h. Given that the microbiological identification is of major importance for patient management, new diagnostic methods are needed in order to detect and identify microorganisms in a timely and accurate manner. Over the last few years, several molecular techniques based on the amplification of microbial nucleic acids have been developed with the aim of reducing the time needed for the identification of the microorganisms involved in different infectious processes. On the other hand, mass spectrometry has emerged as a rapid and consistent alternative to conventional methods for microorganism identification. This review describes the most widely used mass spectrometry technologies -matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) and electrospray ionization time-of-flight (ESI-TOF)-, both for protein and nucleic acid analysis, as well as the commercial platforms available. Related publications of most interest in clinical microbiology are also reviewed. Copyright © 2011 Elsevier España, S.L. All rights reserved.

Determination of optimal glycerol concentration for optical tissue clearing

NASA Astrophysics Data System (ADS)

Youn, Eungjun; Son, Taeyoon; Kim, Han-Sung; Jung, Byungjo

2012-02-01

The laser scattering in tissue is significant in diagnostic and therapeutic purposes of laser. Many studies have been conducted to minimize laser scattering in tissue and therefore, to maximize the clinical efficacy by enhancing photon density. Optical clearing agents (OCAs) have been employed for optical tissue clearing (OTC). This study was aimed to investigate the optimal concentration of an OCA, glycerol, in topical application,, so that it can be utilized for clinical diagnosis and therapy in dermatology. Glycerol was topically applied to avoid possible edema caused by dermal injection. The effect of OTC was quantitatively evaluated as a function of the concentration of glycerol with various methods. Optical methods such as optical coherence tomography (OCT) and an integrating sphere were used to assess the enhancement of light penetration depth and refractive index matching. In addition, a non-optical method, ultrasound scanner, was utilized to evaluate quantitatively collagen dissociation. The results revealed that 70 % glycerol was the optimal concentration of OTC for topical application. This study may provide a guideline regarding to the use of glycerol for optimal diagnostic and therapeutic effects in dermatology.

Advanced imaging techniques for small bowel Crohn's disease: what does the future hold?

PubMed

Pita, Inês; Magro, Fernando

2018-01-01

Treatment of Crohn's disease (CD) is intrinsically reliant on imaging techniques, due to the preponderance of small bowel disease and its transmural pattern of inflammation. Ultrasound (US), computed tomography (CT) and magnetic resonance imaging (MRI) are the most widely employed imaging methods and have excellent diagnostic accuracy in most instances. Some limitations persist, perhaps the most clinically relevant being the distinction between inflammatory and fibrotic strictures. In this regard, several methodologies have recently been tested in animal models and human patients, namely US strain elastography, shear wave elastography, contrast-enhanced US, magnetization transfer MRI and contrast dynamics in standard MRI. Technical advances in each of the imaging methods may expand their indications. The addition of oral contrast to abdominal US appears to substantially improve its diagnostic capabilities compared to standard US. Ionizing dose-reduction methods in CT can decrease concern about cumulative radiation exposure in CD patients and diffusion-weighted MRI may reduce the need for gadolinium contrast. Clinical indexes of disease activity and severity are also increasingly relying on imaging scores, such as the recently developed Lémann Index. In this review we summarize some of the recent advances in small bowel CD imaging and how they might affect clinical practice in the near future.

New clinical opportunities for retinal vascular imaging: adaptive optics to OCT angiography

NASA Astrophysics Data System (ADS)

Rosen, Richard; Chui, Toco; Weitz, Rishard; Dubra, Alfredo; Carroll, Joseph; Garcia, Patricia; Pinhas, Alexander; Scripsema, Nicole; Mo, Shelley; Agemy, Steven; Krawitz, Brian

2018-03-01

As techniques of retinal imaging have evolved, anatomic features that were only assessable in the laboratory have become available in the clinic for patient care. The retinal capillaries were initially described on microscope sections in the pathology laboratory. As optical methods have advanced these features have become part of the routine clinical landscape inspected daily by physicians. This paper briefly traces the evolution of these techniques and shows how they fit into the modern diagnostic armamentarium of ophthalmic retinal care.

Hematology of the domestic ferret (Mustela putorius furo).

PubMed

Smith, Stephen A; Zimmerman, Kurt; Moore, David M

2015-01-01

Pet ferrets are presented to veterinary clinics for routine care and treatment of clinical diseases and female reproductive problems. In addition to obtaining clinical history, additional diagnostic testing may be required, including hematological assessments. This article describes common blood collection methods, including venipuncture sites, volume of blood that can be safely collected, and handling of the blood. Hematological parameters for normal ferrets are provided along with a description of the morphology of ferret leukocytes to assist in performing a differential count.

A new method to address verification bias in studies of clinical screening tests: cervical cancer screening assays as an example.

PubMed

Xue, Xiaonan; Kim, Mimi Y; Castle, Philip E; Strickler, Howard D

2014-03-01

Studies to evaluate clinical screening tests often face the problem that the "gold standard" diagnostic approach is costly and/or invasive. It is therefore common to verify only a subset of negative screening tests using the gold standard method. However, undersampling the screen negatives can lead to substantial overestimation of the sensitivity and underestimation of the specificity of the diagnostic test. Our objective was to develop a simple and accurate statistical method to address this "verification bias." We developed a weighted generalized estimating equation approach to estimate, in a single model, the accuracy (eg, sensitivity/specificity) of multiple assays and simultaneously compare results between assays while addressing verification bias. This approach can be implemented using standard statistical software. Simulations were conducted to assess the proposed method. An example is provided using a cervical cancer screening trial that compared the accuracy of human papillomavirus and Pap tests, with histologic data as the gold standard. The proposed approach performed well in estimating and comparing the accuracy of multiple assays in the presence of verification bias. The proposed approach is an easy to apply and accurate method for addressing verification bias in studies of multiple screening methods. Copyright © 2014 Elsevier Inc. All rights reserved.

[Clinical analysis of thoracoscopy of 30 coalworker's pneumoconiosiswith pleural effusion cases].

PubMed

Liang, Yandong; Jiang, Ruiling; Yu, Chunxiao; Huang, Cheng

2015-07-01

To investigate the diagnostic value of thoracoscopy on idiopathic coalworker's pneumoconiosis with pleural effusion in general medicine. Routine (general medicine) thoracoscopyof patients suffering from iIdiopathiccoalworker's pneumoconiosis with pleural effusion, pathological examination of lesions obtained (direct vision). Pathological examination revealed grayish-white miliary nodules with multiple protruding nodules, irregular focal pleura thickening, pulmonary congestion, edema, fibrous adhesion. Thorascopy produced a diagnostic rate of 93.3%. Confirmed cases includes 13 cases of tuberculous pleurisy, 11 cases of malignant pleural effusion, 4 cases of cardiac insufficiency with pleural effusion and 2 cases of idiopathic pleural effusion, with no serious complications. Thoracoscopy of idiopathic coalworker's pneumoconiosis with pleural effusion is a safe, accurate diagnostic methodin general medicine, and could benefit the establishment of a treatment method quickly, visual observation of the lesions of patients suffering from coalworker's pneumoconiosis with pleural effusion using thoracoscopy, and at the same time offer preliminary investigationof the correlation between the intensity and compactibilityof coal macule distribution and clinical stages of coalworker's Pneumoconiosis.

VIRUS ISOLATION AND MOLECULAR DETECTION OF BLUETONGUE AND EPIZOOTIC HEMORRHAGIC DISEASE VIRUSES FROM NATURALLY INFECTED WHITE-TAILED DEER (ODOCOILEUS VIRGINIANUS).

PubMed

Kienzle, Clara; Poulson, Rebecca L; Ruder, Mark G; Stallknecht, David E

2017-10-01

Hemorrhagic disease in North America is caused by multiple serotypes of epizootic hemorrhagic disease virus (EHDV) and bluetongue virus (BTV). Diagnostic tests for detection of EHDV and BTV include virus isolation (VI), reverse transcriptase (RT)-PCR, and real-time RT-PCR (rRT-PCR). Our objective was to compare the diagnostic capabilities of three rRT-PCR protocols for detection of EHDV and BTV from naturally infected white-tailed deer (Odocoileus virginianus). We compared the effectiveness of these assays to traditional viral detection methods (e.g., VI) for historic and current clinical cases. Because of the variable nature of tissue collection and storage before diagnostic testing, an evaluation of viral persistence on multiple freeze-thaw events was also conducted. Two of the rRT-PCR assays provided for reliable detection of EHDV and BTV from 100% of clinically affected and VI-confirmed infected animals. Additionally, no significant change in viral titer was observed on multiple freeze-thaw events.

Swapping Horses Midstream: Factors Related to Physicians’ Changing Their Minds About a Diagnosis

PubMed Central

Eva, Kevin W.; Link, Carol L.; Lutfey, Karen E.; McKinlay, John B.

2013-01-01

Purpose Premature closure has been identified as the single most common cause of diagnostic error. The authors conducted a factorial experiment to explore which variables exert an unconfounded influence on physicians’ diagnostic flexibility (changing their minds about the most likely diagnosis during a clinical case presentation). Methods In 2007–2008, 256 practicing physicians viewed a clinically authentic vignette simulating a patient presenting with possible coronary heart disease (CHD), provided their initial impression midway through the case, answered questions about the case, indicated how they would continue their clinical investigation, and made a final diagnosis. The authors used general linear models to determine which patient factors (age, gender, socioeconomic status, race), physician factors (gender, age/experience), and process variables were related to the likelihood of physicians’ changing their minds about the most likely diagnosis. Results Physicians who had less experience, those who named a non-CHD diagnosis as their initial impression, and those who did not ask for information about the patient’s prior cardiac disease history were the most likely to change their minds. Participants’ certainty in their initial diagnosis, the additional information desired, the diagnostic hypotheses generated, and the follow-up intended were not related to the likelihood of change in diagnostic hypotheses. Discussion While efforts encouraging physicians to avoid cognitive biases and to reason in a more analytic manner may yield some benefit, this study suggests that experience is a more important determinant of diagnostic flexibility than is the consideration of additional diagnoses or the amount of additional information collected. PMID:20592506

Candida bloodstream infection: a clinical microbiology laboratory perspective.

PubMed

Pongrácz, Júlia; Kristóf, Katalin

2014-09-01

The incidence of Candida bloodstream infection (BSI) has been on the rise in several countries worldwide. Species distribution is changing; an increase in the percentage of non-albicans species, mainly fluconazole non-susceptible C. glabrata was reported. Existing microbiology diagnostic methods lack sensitivity, and new methods need to be developed or further evaluation for routine application is necessary. Although reliable, standardized methods for antifungal susceptibility testing are available, the determination of clinical breakpoints remains challenging. Correct species identification is important and provides information on the intrinsic susceptibility profile of the isolate. Currently, acquired resistance in clinical Candida isolates is rare, but reports indicate that it could be an issue in the future. The role of the clinical microbiology laboratory is to isolate and correctly identify the infective agent and provide relevant and reliable susceptibility data as soon as possible to guide antifungal therapy.

Clinical evaluation of cobas core anti-dsDNA EIA quant.

PubMed

González, Concepción; Guevara, Paloma; García-Berrocal, Belén; Alejandro Navajo, José; Manuel González-Buitrago, José

2004-01-01

The measurement of antibodies to double-stranded DNA (anti-dsDNA) is a useful tool for the diagnosis and monitoring of patients with connective tissue diseases, particularly systemic lupus erythematosus (SLE). The aim of the present study was to compare a new enzyme-linked immunosorbent assay (ELISA) for the measurement of anti-dsDNA antibodies, which uses purified double-stranded plasmid DNA as the antigen (anti-dsDNA EIA Quant; Roche Diagnostics, Mannheim, Germany), with an established ELISA. The clinical usefulness of this new ELISA was also assessed. We measured anti-dsDNA antibodies in 398 serum samples that were divided into four groups: 1). routine samples sent to our laboratory for an antinuclear antibody (ANA) test (n=229), 2). samples from blood donors (n=74), 3). samples from patients with SLE (n=48), and 4) samples from patients with other autoimmune diseases (n=47). The methods used were the Cobas Core Anti-dsDNA EIA Quant (Roche Diagnostics, Mannheim, Germany) and the Anti-dsDNA test (Gull Diagnostics, Bois d'Arcy, France). We obtained a kappa index and Spearman correlation coefficient in the comparative study, and sensitivity, specificity, predictive values, and likelihood ratios in the clinical study. The results obtained show a good agreement between the two methods in both the qualitative results (kappa=0.91) and the quantitative data (r=0.854). The best accuracy, predictive values, likelihood ratios, and correlation with active disease were obtained with the Roche anti-dsDNA assay. Copyright 2004 Wiley-Liss, Inc.

The Research Diagnostic Criteria for Temporomandibular Disorders. I: overview and methodology for assessment of validity.

PubMed

Schiffman, Eric L; Truelove, Edmond L; Ohrbach, Richard; Anderson, Gary C; John, Mike T; List, Thomas; Look, John O

2010-01-01

The purpose of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project was to assess the diagnostic validity of this examination protocol. The aim of this article is to provide an overview of the project's methodology, descriptive statistics, and data for the study participant sample. This article also details the development of reliable methods to establish the reference standards for assessing criterion validity of the Axis I RDC/TMD diagnoses. The Axis I reference standards were based on the consensus of two criterion examiners independently performing a comprehensive history, clinical examination, and evaluation of imaging. Intersite reliability was assessed annually for criterion examiners and radiologists. Criterion examination reliability was also assessed within study sites. Study participant demographics were comparable to those of participants in previous studies using the RDC/TMD. Diagnostic agreement of the criterion examiners with each other and with the consensus-based reference standards was excellent with all kappas > or = 0.81, except for osteoarthrosis (moderate agreement, k = 0.53). Intrasite criterion examiner agreement with reference standards was excellent (k > or = 0.95). Intersite reliability of the radiologists for detecting computed tomography-disclosed osteoarthrosis and magnetic resonance imaging-disclosed disc displacement was good to excellent (k = 0.71 and 0.84, respectively). The Validation Project study population was appropriate for assessing the reliability and validity of the RDC/TMD Axis I and II. The reference standards used to assess the validity of Axis I TMD were based on reliable and clinically credible methods.

Information engineering for molecular diagnostics.

PubMed Central

Sorace, J. M.; Ritondo, M.; Canfield, K.

1994-01-01

Clinical laboratories are beginning to apply the recent advances in molecular biology to the testing of patient samples. The emerging field of Molecular Diagnostics will require a new Molecular Diagnostics Laboratory Information System which handles the data types, samples and test methods found in this field. The system must be very flexible in regards to supporting ad-hoc queries. The requirements which are shaping the developments in this field are reviewed and a data model developed. Several queries which demonstrate the data models ability to support the information needs of this area have been developed and run. These results demonstrate the ability of the purposed data model to meet the current and projected needs of this rapidly expanding field. PMID:7949937

Diagnosis demystified: CT as diagnostic tool in endodontics

PubMed Central

Shruthi, Nagaraja; Sreenivasa Murthy, B V; Sundaresh, K J; Mallikarjuna, Rachappa

2013-01-01

Diagnosis in endodontics is usually based on clinical and radiographical presentations, which are only empirical methods. The role of healing profession is to apply knowledge and skills towards maintaining and restoring the patient's health. Recent advances in imaging technologies have added to correct interpretation and diagnosis. CT is proving to be an effective tool in solving endodontic mysteries through its three-dimensional visualisation. CT imaging offers many diagnostic advantages to produce reconstructed images in selected projection and low-contrast resolution far superior to that of all other X-ray imaging modalities. This case report is an endeavour towards effective treatment planning of cases with root fracture, root resorption using spiral CT as an adjuvant diagnostic tool. PMID:23814212

Chromosomal Microarray Testing in 42 Korean Patients with Unexplained Developmental Delay, Intellectual Disability, Autism Spectrum Disorders, and Multiple Congenital Anomalies.

PubMed

Lee, Sun Ho; Song, Wung Joo

2017-09-01

Chromosomal microarray (CMA) is a high-resolution, high-throughput method of identifying submicroscopic genomic copy number variations (CNVs). CMA has been established as the first-line diagnostic test for individuals with developmental delay (DD), intellectual disability (ID), autism spectrum disorders (ASDs), and multiple congenital anomalies (MCAs). CMA analysis was performed in 42 Korean patients who had been diagnosed with unexplained DD, ID, ASDs, and MCAs. Clinically relevant CNVs were discovered in 28 patients. Variants of unknown significance were detected in 13 patients. The diagnostic yield was high (66.7%). CMA is a superior diagnostic tool compared with conventional karyotyping and fluorescent in situ hybridization.

Food and Drug Administration Regulation of in Vitro Diagnostic Devices

PubMed Central

Mansfield, Elizabeth; O’Leary, Timothy J.; Gutman, Steven I.

2005-01-01

The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification [510(k)] pathway. We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation. PMID:15681468

Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial.

PubMed

Reyburn, Hugh; Mbakilwa, Hilda; Mwangi, Rose; Mwerinde, Ombeni; Olomi, Raimos; Drakeley, Chris; Whitty, Christopher J M

2007-02-24

To compare rapid diagnostic tests (RDTs) for malaria with routine microscopy in guiding treatment decisions for febrile patients. Randomised trial. Outpatient departments in northeast Tanzania at varying levels of malaria transmission. 2416 patients for whom a malaria test was requested. Staff received training on rapid diagnostic tests; patients sent for malaria tests were randomised to rapid diagnostic test or routine microscopy Proportion of patients with a negative test prescribed an antimalarial drug. Of 7589 outpatient consultations, 2425 (32%) had a malaria test requested. Of 1204 patients randomised to microscopy, 1030 (86%) tested negative for malaria; 523 (51%) of these were treated with an antimalarial drug. Of 1193 patients randomised to rapid diagnostic test, 1005 (84%) tested negative; 540 (54%) of these were treated for malaria (odds ratio 1.13, 95% confidence interval 0.95 to 1.34; P=0.18). Children aged under 5 with negative rapid diagnostic tests were more likely to be prescribed an antimalarial drug than were those with negative slides (P=0.003). Patients with a negative test by any method were more likely to be prescribed an antibiotic (odds ratio 6.42, 4.72 to 8.75; P<0.001). More than 90% of prescriptions for antimalarial drugs in low-moderate transmission settings were for patients for whom a test requested by a clinician was negative for malaria. Although many cases of malaria are missed outside the formal sector, within it malaria is massively over-diagnosed. This threatens the sustainability of deployment of artemisinin combination treatment, and treatable bacterial diseases are likely to be missed. Use of rapid diagnostic tests, with basic training for clinical staff, did not in itself lead to any reduction in over-treatment for malaria. Interventions to improve clinicians' management of febrile illness are essential but will not be easy. Clinical trials NCT00146796 [ClinicalTrials.gov].

Study of Cardiovascular Health Outcomes in the Era of Claims Data: The Cardiovascular Health Study.

PubMed

Psaty, Bruce M; Delaney, Joseph A; Arnold, Alice M; Curtis, Lesley H; Fitzpatrick, Annette L; Heckbert, Susan R; McKnight, Barbara; Ives, Diane; Gottdiener, John S; Kuller, Lewis H; Longstreth, W T

2016-01-12

Increasingly, the diagnostic codes from administrative claims data are being used as clinical outcomes. Data from the Cardiovascular Health Study (CHS) were used to compare event rates and risk factor associations between adjudicated hospitalized cardiovascular events and claims-based methods of defining events. The outcomes of myocardial infarction (MI), stroke, and heart failure were defined in 3 ways: the CHS adjudicated event (CHS[adj]), selected International Classification of Diseases, Ninth Edition diagnostic codes only in the primary position for Medicare claims data from the Center for Medicare & Medicaid Services (CMS[1st]), and the same selected diagnostic codes in any position (CMS[any]). Conventional claims-based methods of defining events had high positive predictive values but low sensitivities. For instance, the positive predictive value of International Classification of Diseases, Ninth Edition code 410.x1 for a new acute MI in the first position was 90.6%, but this code identified only 53.8% of incident MIs. The observed event rates for CMS[1st] were low. For MI, the incidence was 14.9 events per 1000 person-years for CHS[adj] MI, 8.6 for CMS[1st] MI, and 12.2 for CMS[any] MI. In general, cardiovascular disease risk factor associations were similar across the 3 methods of defining events. Indeed, traditional cardiovascular disease risk factors were also associated with all first hospitalizations not resulting from an MI. The use of diagnostic codes from claims data as clinical events, especially when restricted to primary diagnoses, leads to an underestimation of event rates. Additionally, claims-based events data represent a composite end point that includes the outcome of interest and selected (misclassified) nonevent hospitalizations. © 2015 American Heart Association, Inc.

Sonoelastographic evaluation with the determination of compressibility ratio for symmetrical prostatic regions in the diagnosis of clinically significant prostate cancer

PubMed Central

Słapa, Rafał Z.; Jakubowski, Wiesław S.; Migda, Bartosz; Dmowski, Tadeusz

2014-01-01

Aim Sonoelastography is a technique that assesses tissue hardness/compressibility. Utility and sensitivity of the method in prostate cancer diagnostics were assessed compared to the current gold standard in prostate cancer diagnostics i.e. systematic biopsy. Material and methods The study involved 84 patients suspected of prostate cancer based on elevated PSA levels or abnormal per rectal examination findings. Sonoelastography was used to evaluate the prostate gland. In the case of regions with hardness two-fold greater than that of symmetric prostate area (strain ratio >2), targeted biopsy was used; which was followed by an ultrasound-guided 8- or 10-core systematic biopsy (regardless of sonoelastography-indicated sites) as a reference point. Results The mean age of patients was 69 years. PSA serum levels ranged between 1.02 and 885 ng/dl. The mean prostate volume was 62 ml (19–149 ml). Prostate cancer was found in 39 out of 84 individuals. Statistically significant differences in strain ratios between cancers and benign lesions were shown. Sonoelastography guided biopsy revealed 30 lesions – overall sensitivity 77% (sensitivity of the method – 81%). Sonoelastographic sensitivity increased depending on cancer stage according to the Gleason grading system: 6–60%, 7–75%, 8–83%, 9/10–100%. The estimated sensitivity of systematic biopsy was 92%. Conclusions Sonoelastography shows higher diagnostic sensitivity in prostate cancer diagnostics compared to conventional imaging techniques, i.e. grey-scale TRUS, Doppler ultrasound. It allows to reduce the number of collected tissue cores, and thus limit the incidence of complications as well as the costs involved. Sonoelastography using the determination of compressibility ratio for symmetrical prostatic regions may prove useful in the detection of clinically significant prostate cancer. PMID:26674065

Rapid and effective processing of blood specimens for diagnostic PCR using filter paper and Chelex-100.

PubMed Central

Polski, J M; Kimzey, S; Percival, R W; Grosso, L E

1998-01-01

AIM: To provide a more efficient method for isolating DNA from peripheral blood for use in diagnostic DNA mutation analysis. METHODS: The use of blood impregnated filter paper and Chelex-100 in DNA isolation was evaluated and compared with standard DNA isolation techniques. RESULTS: In polymerase chain reaction (PCR) based assays of five point mutations, identical results were obtained with DNA isolated routinely from peripheral blood and isolated using the filter paper and Chelex-100 method. CONCLUSION: In the clinical setting, this method provides a useful alternative to conventional DNA isolation. It is easily implemented and inexpensive, and provides sufficient, stable DNA for multiple assays. The potential for specimen contamination is reduced because most of the steps are performed in a single microcentrifuge tube. In addition, this method provides for easy storage and transport of samples from the point of acquisition. PMID:9893748

The Assessment of Math Learning Difficulties in a Primary Grade-4 Child with High Support Needs: Mixed Methods Approach

ERIC Educational Resources Information Center

Mundia, Lawrence

2012-01-01

This mixed-methods study incorporated elements of survey, case study and action research approaches in investigating an at-risk child. Using an in-take interview, a diagnostic test, an error analysis, and a think-aloud clinical interview, the study identified the child's major presenting difficulties. These included: inability to use the four…

Diagnostic and Prognostic Significance of Brief Limited Intermittent Psychotic Symptoms (BLIPS) in Individuals at Ultra High Risk

PubMed Central

Fusar-Poli, Paolo; Cappucciati, Marco; De Micheli, Andrea; Rutigliano, Grazia; Bonoldi, Ilaria; Tognin, Stefania; Ramella-Cravaro, Valentina; Castagnini, Augusto; McGuire, Philip

2017-01-01

Background: Brief Limited Intermittent Psychotic Symptoms (BLIPS) are key inclusion criteria to define individuals at ultra high risk for psychosis (UHR). Their diagnostic and prognostic significance is unclear. Objectives: To address the baseline diagnostic relationship between BLIPS and the ICD-10 categories and examine the longitudinal prognostic impact of clinical and sociodemographic factors. Methods: Prospective long-term study in UHR individuals meeting BLIPS criteria. Sociodemographic and clinical data, including ICD-10 diagnoses, were automatically drawn from electronic health records and analyzed using Kaplan–Meier failure function (1-survival), Cox regression models, bootstrapping methods, and Receiver Operating Characteristics (ROC) curve. Results: Eighty BLIPS were included. At baseline, two-thirds (68%) of BLIPS met the diagnostic criteria for ICD-10 Acute and Transient Psychotic Disorder (ATPD), most featuring schizophrenic symptoms. The remaining individuals met ICD-10 diagnostic criteria for unspecified nonorganic psychosis (15%), mental and behavioral disorders due to use of cannabinoids (11%), and mania with psychotic symptoms (6%). The overall 5-year risk of psychosis was 0.54. Recurrent episodes of BLIPS were relatively rare (11%) but associated with a higher risk of psychosis (hazard ratio [HR] 3.98) than mono-episodic BLIPS at the univariate analysis. Multivariate analysis revealed that seriously disorganizing or dangerous features increased greatly (HR = 4.39) the risk of psychosis (0.89 at 5-year). Bootstrapping confirmed the robustness of this predictor (area under the ROC = 0.74). Conclusions: BLIPS are most likely to fulfill the ATPD criteria, mainly acute schizophrenic subtypes. About half of BLIPS cases develops a psychotic disorder during follow-up. Recurrent BLIPS are relatively rare but tend to develop into psychosis. BLIPS with seriously disorganizing or dangerous features have an extreme high risk of psychosis. PMID:28053130

Current diagnostic procedures for diagnosing vertigo and dizziness

PubMed Central

Walther, Leif Erik

2017-01-01

Vertigo is a multisensory syndrome that otolaryngologists are confronted with every day. With regard to the complex functions of the sense of orientation, vertigo is considered today as a disorder of the sense of direction, a disturbed spatial perception of the body. Beside the frequent classical syndromes for which vertigo is the leading symptom (e.g. positional vertigo, vestibular neuritis, Menière’s disease), vertigo may occur as main or accompanying symptom of a multitude of ENT-related diseases involving the inner ear. It also concerns for example acute and chronic viral or bacterial infections of the ear with serous or bacterial labyrinthitis, disorders due to injury (e.g. barotrauma, fracture of the oto-base, contusion of the labyrinth), chronic-inflammatory bone processes as well as inner ear affections in the perioperative course. In the last years, diagnostics of vertigo have experienced a paradigm shift due to new diagnostic possibilities. In the diagnostics of emergency cases, peripheral and central disorders of vertigo (acute vestibular syndrome) may be differentiated with simple algorithms. The introduction of modern vestibular test procedures (video head impulse test, vestibular evoked myogenic potentials) in the clinical practice led to new diagnostic options that for the first time allow a complex objective assessment of all components of the vestibular organ with relatively low effort. Combined with established methods, a frequency-specific assessment of the function of vestibular reflexes is possible. New classifications allow a clinically better differentiation of vertigo syndromes. Modern radiological procedures such as for example intratympanic gadolinium application for Menière’s disease with visualization of an endolymphatic hydrops also influence current medical standards. Recent methodical developments significantly contributed to the possibilities that nowadays vertigo can be better and more quickly clarified in particular in otolaryngology. PMID:29279722

Cost-effectiveness of malaria diagnosis using rapid diagnostic tests compared to microscopy or clinical symptoms alone in Afghanistan.

PubMed

Hansen, Kristian S; Grieve, Eleanor; Mikhail, Amy; Mayan, Ismail; Mohammed, Nader; Anwar, Mohammed; Baktash, Sayed H; Drake, Thomas L; Whitty, Christopher J M; Rowland, Mark W; Leslie, Toby J

2015-05-28

Improving access to parasitological diagnosis of malaria is a central strategy for control and elimination of the disease. Malaria rapid diagnostic tests (RDTs) are relatively easy to perform and could be used in primary level clinics to increase coverage of diagnostics and improve treatment of malaria. A cost-effectiveness analysis was undertaken of RDT-based diagnosis in public health sector facilities in Afghanistan comparing the societal and health sector costs of RDTs versus microscopy and RDTs versus clinical diagnosis in low and moderate transmission areas. The effect measure was 'appropriate treatment for malaria' defined using a reference diagnosis. Effects were obtained from a recent trial of RDTs in 22 public health centres with cost data collected directly from health centres and from patients enrolled in the trial. Decision models were used to compare the cost of RDT diagnosis versus the current diagnostic method in use at the clinic per appropriately treated case (incremental cost-effectiveness ratio, ICER). RDT diagnosis of Plasmodium vivax and Plasmodium falciparum malaria in patients with uncomplicated febrile illness had higher effectiveness and lower cost compared to microscopy and was cost-effective across the moderate and low transmission settings. RDTs remained cost-effective when microscopy was used for other clinical purposes. In the low transmission setting, RDTs were much more effective than clinical diagnosis (65.2% (212/325) vs 12.5% (40/321)) but at an additional cost (ICER) of US$4.5 per appropriately treated patient including a health sector cost (ICER) of US$2.5 and household cost of US$2.0. Sensitivity analysis, which varied drug costs, indicated that RDTs would remain cost-effective if artemisinin combination therapy was used for treating both P. vivax and P. falciparum. Cost-effectiveness of microscopy relative to RDT is further reduced if the former is used exclusively for malaria diagnosis. In the health service setting of Afghanistan, RDTs are a cost-effective intervention compared to microscopy. RDTs remain cost-effective across a range of drug costs and if microscopy is used for a range of diagnostic services. RDTs have significant advantages over clinical diagnosis with minor increases in the cost of service provision. The trial was registered at ClinicalTrials.gov under identifier NCT00935688.

[Current status and clinical application prospect of Akabane's test].

PubMed

Wang, Wenjie; Du, Yanjun

2016-06-12

The Akabane's test is one of the meridian diagnostic methods. Compared with the current meridian diagnostic methods, it has the advantages of convenience and efficiency, but it also has several disadvantages such as the accuracy is difficult to control, the outcome interpretation is limited, etc. In this paper, the influence factors of Akabane's test were analyzed one by one, especially proposed personal opinion on outcome interpretation, which could ascertain the location and nature of disease, leading to disease syndrome. With accurate syndrome, the treatment plan could be established. The application prospect of Akabane's test was initially explored, and it was proposed that wearable automation equipment could be one of the development directions.

Oral exfoliative cytology in the diagnosis of paracoccidioidomycosis.

PubMed

de Araújo, M S; Mesquita, R A; Corrêa, L; de Sousa, S O

2001-01-01

To assess the efficacy of conventional oral exfoliative cytology as a diagnostic tool in paracoccidioidomycosis. Cytologic smears and incisional biopsies were obtained from 10 patients with a clinical suspicion and oral manifestations of paracoccidioidomycosis. Cytologic smears and sections of the incisional biopsy underwent methenamine silver staining for fungi according to the Gomori-Grocott method. The dry glass slides were examined at 400 or 1,000 x magnification, and the presence and shape of yeasts of Paracoccidioides brasiliensis were investigated. Yeasts of the fungus P brasiliensis were clearly identified in cytologic smears and sections from incisional biopsies in all cases analyzed (100.0%). Cytology of oral samples proved an effective diagnostic method for the detection of paracoccidioidomycosis in humans.

Practice advisory: The utility of EEG theta/beta power ratio in ADHD diagnosis

PubMed Central

Gloss, David; Varma, Jay K.; Pringsheim, Tamara; Nuwer, Marc R.

2016-01-01

Objective: To evaluate the evidence for EEG theta/beta power ratio for diagnosing, or helping to diagnose, attention-deficit/hyperactivity disorder (ADHD). Methods: We identified relevant studies and classified them using American Academy of Neurology criteria. Results: Two Class I studies assessing the ability of EEG theta/beta power ratio and EEG frontal beta power to identify patients with ADHD correctly identified 166 of 185 participants. Both studies evaluated theta/beta power ratio and frontal beta power in suspected ADHD or in syndromes typically included in an ADHD differential diagnosis. A bivariate model combining the diagnostic studies shows that the combination of EEG frontal beta power and theta/beta power ratio has relatively high sensitivity and specificity but is insufficiently accurate. Conclusions: It is unknown whether a combination of standard clinical examination and EEG theta/beta power ratio increases diagnostic certainty of ADHD compared with clinical examination alone. Recommendations: Level B: Clinicians should inform patients with suspected ADHD and their families that the combination of EEG theta/beta power ratio and frontal beta power should not replace a standard clinical evaluation. There is a risk for significant harm to patients from ADHD misdiagnosis because of the unacceptably high false-positive diagnostic rate of EEG theta/beta power ratio and frontal beta power. Level R: Clinicians should inform patients with suspected ADHD and their families that the EEG theta/beta power ratio should not be used to confirm an ADHD diagnosis or to support further testing after a clinical evaluation, unless such diagnostic assessments occur in a research setting. PMID:27760867

Accuracy of dengue clinical diagnosis with and without NS1 antigen rapid test: Comparison between human and Bayesian network model decision.

PubMed

Sa-Ngamuang, Chaitawat; Haddawy, Peter; Luvira, Viravarn; Piyaphanee, Watcharapong; Iamsirithaworn, Sopon; Lawpoolsri, Saranath

2018-06-18

Differentiating dengue patients from other acute febrile illness patients is a great challenge among physicians. Several dengue diagnosis methods are recommended by WHO. The application of specific laboratory tests is still limited due to high cost, lack of equipment, and uncertain validity. Therefore, clinical diagnosis remains a common practice especially in resource limited settings. Bayesian networks have been shown to be a useful tool for diagnostic decision support. This study aimed to construct Bayesian network models using basic demographic, clinical, and laboratory profiles of acute febrile illness patients to diagnose dengue. Data of 397 acute undifferentiated febrile illness patients who visited the fever clinic of the Bangkok Hospital for Tropical Diseases, Thailand, were used for model construction and validation. The two best final models were selected: one with and one without NS1 rapid test result. The diagnostic accuracy of the models was compared with that of physicians on the same set of patients. The Bayesian network models provided good diagnostic accuracy of dengue infection, with ROC AUC of 0.80 and 0.75 for models with and without NS1 rapid test result, respectively. The models had approximately 80% specificity and 70% sensitivity, similar to the diagnostic accuracy of the hospital's fellows in infectious disease. Including information on NS1 rapid test improved the specificity, but reduced the sensitivity, both in model and physician diagnoses. The Bayesian network model developed in this study could be useful to assist physicians in diagnosing dengue, particularly in regions where experienced physicians and laboratory confirmation tests are limited.

Diagnostic work-up and loss of tuberculosis suspects in Jogjakarta, Indonesia.

PubMed

Ahmad, Riris Andono; Matthys, Francine; Dwihardiani, Bintari; Rintiswati, Ning; de Vlas, Sake J; Mahendradhata, Yodi; van der Stuyft, Patrick

2012-02-15

Early and accurate diagnosis of pulmonary tuberculosis (TB) is critical for successful TB control. To assist in the diagnosis of smear-negative pulmonary TB, the World Health Organisation (WHO) recommends the use of a diagnostic algorithm. Our study evaluated the implementation of the national tuberculosis programme's diagnostic algorithm in routine health care settings in Jogjakarta, Indonesia. The diagnostic algorithm is based on the WHO TB diagnostic algorithm, which had already been implemented in the health facilities. We prospectively documented the diagnostic work-up of all new tuberculosis suspects until a diagnosis was reached. We used clinical audit forms to record each step chronologically. Data on the patient's gender, age, symptoms, examinations (types, dates, and results), and final diagnosis were collected. Information was recorded for 754 TB suspects; 43.5% of whom were lost during the diagnostic work-up in health centres, 0% in lung clinics. Among the TB suspects who completed diagnostic work-ups, 51.1% and 100.0% were diagnosed without following the national TB diagnostic algorithm in health centres and lung clinics, respectively. However, the work-up in the health centres and lung clinics generally conformed to international standards for tuberculosis care (ISTC). Diagnostic delays were significantly longer in health centres compared to lung clinics. The high rate of patients lost in health centres needs to be addressed through the implementation of TB suspect tracing and better programme supervision. The national TB algorithm needs to be revised and differentiated according to the level of care.

[Clinical picture, diagnostics and prophylaxis of a syndrome in conditions of the Far North].

PubMed

Ukhocskiĭ, D M; Tegza, V Iu; Rezvantsev, M V; Vasil'chenko, V V; Belikova, T M

2014-10-01

The analysis of a clinical picture barometeosensitivity in a seaside zone of the Far North is carried out in the article. A diagnostic test included the following laboratory assessments: complete blood count, complete urinary analysis, biomedical measurement assessment, immunology blood research and functional renal test; analysis of the level of an electrolyte in the blood and hormone receptor status; and the following instrumental diagnostics: The auscultatory Korotkov's method of determining blood pressure, electrocardiography, variational pulsometry, chest X-ray, mechanocardiography, echocardiography and abdominal ultrasound; and also consultation of ophthalmologist and neuropathologist. Every patient should keep a diary "weather - health" before and after the treatment. Peculiarities of cardiovascular system, vegetative systems and neuroendocrine system of servicemen, coming to the Far North and mechanisms of development of barometeosensivity were revealed. It has been established that atmospheric pressure variation affects systolic and diastolic blood pressure, heart rate, systolic discharge, Kerdo index, effectiveness of myocardial function, end-diastolic and end-systolic volume, level of cholesterol, triglycerides, kalium, adrenalin, triiodothyronine, blood plasma and plasma renin activity in barometeosensetiv servicemen. The criteria of diagnostics of barometeosensivity in conditions of the Far North are suggested. The influence of baromemteosensivity on the combat capability of serviceman is researched.

Multiplex PCR Tests for Detection of Pathogens Associated with Gastroenteritis

PubMed Central

Zhang, Hongwei; Morrison, Scott; Tang, Yi-Wei

2016-01-01

Synopsis A wide range of enteric pathogens can cause infectious gastroenteritis. Conventional diagnostic algorithms including culture, biochemical identification, immunoassay and microscopic examination are time consuming and often lack sensitivity and specificity. Advances in molecular technology have as allowed its use as clinical diagnostic tools. Multiplex PCR based testing has made its way to gastroenterology diagnostic arena in recent years. In this article we present a review of recent laboratory developed multiplex PCR tests and current commercial multiplex gastrointestinal pathogen tests. We will focus on two FDA cleared commercial syndromic multiplex tests: Luminex xTAG GPP and Biofire FimArray GI test. These multiplex tests can detect and identify multiple enteric pathogens in one test and provide results within hours. Multiplex PCR tests have shown superior sensitivity to conventional methods for detection of most pathogens. The high negative predictive value of these multiplex tests has led to the suggestion that they be used as screening tools especially in outbreaks. Although the clinical utility and benefit of multiplex PCR test are to be further investigated, implementing these multiplex PCR tests in gastroenterology diagnostic algorithm has the potential to improve diagnosis of infectious gastroenteritis. PMID:26004652

Source localization of rhythmic ictal EEG activity: a study of diagnostic accuracy following STARD criteria.

PubMed

Beniczky, Sándor; Lantz, Göran; Rosenzweig, Ivana; Åkeson, Per; Pedersen, Birthe; Pinborg, Lars H; Ziebell, Morten; Jespersen, Bo; Fuglsang-Frederiksen, Anders

2013-10-01

Although precise identification of the seizure-onset zone is an essential element of presurgical evaluation, source localization of ictal electroencephalography (EEG) signals has received little attention. The aim of our study was to estimate the accuracy of source localization of rhythmic ictal EEG activity using a distributed source model. Source localization of rhythmic ictal scalp EEG activity was performed in 42 consecutive cases fulfilling inclusion criteria. The study was designed according to recommendations for studies on diagnostic accuracy (STARD). The initial ictal EEG signals were selected using a standardized method, based on frequency analysis and voltage distribution of the ictal activity. A distributed source model-local autoregressive average (LAURA)-was used for the source localization. Sensitivity, specificity, and measurement of agreement (kappa) were determined based on the reference standard-the consensus conclusion of the multidisciplinary epilepsy surgery team. Predictive values were calculated from the surgical outcome of the operated patients. To estimate the clinical value of the ictal source analysis, we compared the likelihood ratios of concordant and discordant results. Source localization was performed blinded to the clinical data, and before the surgical decision. Reference standard was available for 33 patients. The ictal source localization had a sensitivity of 70% and a specificity of 76%. The mean measurement of agreement (kappa) was 0.61, corresponding to substantial agreement (95% confidence interval (CI) 0.38-0.84). Twenty patients underwent resective surgery. The positive predictive value (PPV) for seizure freedom was 92% and the negative predictive value (NPV) was 43%. The likelihood ratio was nine times higher for the concordant results, as compared with the discordant ones. Source localization of rhythmic ictal activity using a distributed source model (LAURA) for the ictal EEG signals selected with a standardized method is feasible in clinical practice and has a good diagnostic accuracy. Our findings encourage clinical neurophysiologists assessing ictal EEGs to include this method in their armamentarium. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

A semi-automated, field-portable microscopy platform for clinical diagnostic applications

NASA Astrophysics Data System (ADS)

Jagannadh, Veerendra Kalyan; Srinivasan, Rajesh; Gorthi, Sai Siva

2015-08-01

Clinical microscopy is a versatile diagnostic platform used for diagnosis of a multitude of diseases. In the recent past, many microfluidics based point-of-care diagnostic devices have been developed, which serve as alternatives to microscopy. However, these point-of-care devices are not as multi-functional and versatile as clinical microscopy. With the use of custom designed optics and microfluidics, we have developed a versatile microscopy-based cellular diagnostic platform, which can be used at the point of care. The microscopy platform presented here is capable of detecting infections of very low parasitemia level (in a very small quantity of sample), without the use of any additional computational hardware. Such a cost-effective and portable diagnostic device, would greatly impact the quality of health care available to people living in rural locations of the world. Apart from clinical diagnostics, it's applicability to field research in environmental microbiology has also been outlined.

Periprosthetic Joint Infections: Clinical and Bench Research

PubMed Central

Legout, Laurence; Senneville, Eric

2013-01-01

Prosthetic joint infection is a devastating complication with high morbidity and substantial cost. The incidence is low but probably underestimated. Despite a significant basic and clinical research in this field, many questions concerning the definition of prosthetic infection as well the diagnosis and the management of these infections remained unanswered. We review the current literature about the new diagnostic methods, the management and the prevention of prosthetic joint infections. PMID:24288493

Clinical practice: vocal nodules in dysphonic children.

PubMed

Martins, Regina Helena Garcia; Branco, Anete; Tavares, Elaine Lara Mendes; Gramuglia, Andrea Cristina Jóia

2013-09-01

Common among children, vocal symptoms are a cause of concern for parents who seek elucidation of their diagnosis and treatment. Vocal nodules are the major cause of dysphonias in children and are related to vocal abuse. We conducted a literature review considering clinical, physiopathological, epidemiological, and histological aspects of vocal nodules, as well as diagnostic methods, highlighting the main studies addressing this issue. The controversial points of treatments were also discussed.

Metabolomics for Biomarker Discovery: Moving to the Clinic

PubMed Central

Zhang, Aihua; Sun, Hui; Yan, Guangli; Wang, Ping; Wang, Xijun

2015-01-01

To improve the clinical course of diseases, more accurate diagnostic and assessment methods are required as early as possible. In order to achieve this, metabolomics offers new opportunities for biomarker discovery in complex diseases and may provide pathological understanding of diseases beyond traditional technologies. It is the systematic analysis of low-molecular-weight metabolites in biological samples and has become an important tool in clinical research and the diagnosis of human disease and has been applied to discovery and identification of the perturbed pathways. It provides a powerful approach to discover biomarkers in biological systems and offers a holistic approach with the promise to clinically enhance diagnostics. When carried out properly, it could provide insight into the understanding of the underlying mechanisms of diseases, help to identify patients at risk of disease, and predict the response to specific treatments. Currently, metabolomics has become an important tool in clinical research and the diagnosis of human disease and becomes a hot topic. This review will highlight the importance and benefit of metabolomics for identifying biomarkers that accurately screen potential biomarkers of diseases. PMID:26090402

DSM-5 pathological personality traits and the personality assessment inventory.

PubMed

Hopwood, Christopher J; Wright, Aidan G C; Krueger, Robert F; Schade, Nick; Markon, Kristian E; Morey, Leslie C

2013-06-01

Section 3 of the DSM-5 will include a pathological personality trait system rooted in the quantitative epistemology of personality and clinical psychology. This system has the potential to enhance the clinical utility of the diagnostic nosology by providing a means for the dimensional assessment of individuals with psychopathology. However, there is limited research on the associations of DSM-5 traits with common mental disorders and related clinical phenomena as measured by currently popular assessment instruments. The purpose of this article was to evaluate the convergence of the DSM-5 trait system with a well-validated broadband clinical instrument, the Personality Assessment Inventory (PAI). Bivariate correlations were examined and factor analytic methods were used to examine the degree to which the DSM-5 traits and PAI capture common variance in personality and mental health. In a student sample (N = 1,001), we found broad convergence between the DSM-5 traits and PAI, which could be organized effectively using five factors. The implications of these findings for using traits to address issues related to diagnostic co-occurrence and heterogeneity in routine clinical assessment are discussed.

CpG Methylation Analysis—Current Status of Clinical Assays and Potential Applications in Molecular Diagnostics

PubMed Central

Sepulveda, Antonia R.; Jones, Dan; Ogino, Shuji; Samowitz, Wade; Gulley, Margaret L.; Edwards, Robin; Levenson, Victor; Pratt, Victoria M.; Yang, Bin; Nafa, Khedoudja; Yan, Liying; Vitazka, Patrick

2009-01-01

Methylation of CpG islands in gene promoter regions is a major molecular mechanism of gene silencing and underlies both cancer development and progression. In molecular oncology, testing for the CpG methylation of tissue DNA has emerged as a clinically useful tool for tumor detection, outcome prediction, and treatment selection, as well as for assessing the efficacy of treatment with the use of demethylating agents and monitoring for tumor recurrence. In addition, because CpG methylation occurs early in pre-neoplastic tissues, methylation tests may be useful as markers of cancer risk in patients with either infectious or inflammatory conditions. The Methylation Working Group of the Clinical Practice Committee of the Association of Molecular Pathology has reviewed the current state of clinical testing in this area. We report here our summary of both the advantages and disadvantages of various methods, as well as the needs for standardization and reporting. We then conclude by summarizing the most promising areas for future clinical testing in cancer molecular diagnostics. PMID:19541921

Integration of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry in blood culture diagnostics: a fast and effective approach.

PubMed

Klein, Sabrina; Zimmermann, Stefan; Köhler, Christine; Mischnik, Alexander; Alle, Werner; Bode, Konrad A

2012-03-01

Sepsis is a major cause of mortality in hospitalized patients worldwide, with lethality rates ranging from 30 to 70 %. Sepsis is caused by a variety of different pathogens, and rapid diagnosis is of outstanding importance, as early and adequate antimicrobial therapy correlates with positive clinical outcome. In recent years, matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry (MS) fingerprinting has become a powerful tool in microbiological diagnostics. The direct identification of micro-organisms in a positive blood culture by MALDI-TOF MS can shorten the diagnostic procedure significantly. Therefore, the aim of the present study was to evaluate whether identification rates could be improved by using the new Sepsityper kit from Bruker Daltonics for direct isolation and identification of bacteria from positive blood cultures by MALDI-TOF MS compared with the use of conventional separator gel columns, and to integrate the MALDI-TOF MS-based identification method into the routine course of blood culture diagnostics in the setting of a microbiological laboratory at a university hospital in Germany. The identification of Gram-negative bacteria by MALDI-TOF MS was significantly better using the Sepsityper kit compared with a separator gel tube-based method (99 and 68 % correct identification, respectively). For Gram-positive bacteria, only 73 % were correctly identified by MALDI-TOF with the Sepsityper kit and 59 % with the separator gel tube assay. A major problem of both methods was the poor identification of Gram-positive grape-like clustered cocci. As differentiation of Staphylococcus aureus from coagulase-negative staphylococci is of clinical importance, a PCR was additionally established that was capable of identifying S. aureus directly from positive blood cultures, thus closing this diagnostic gap. Another benefit of the PCR approach is the possibility of directly detecting the genes responsible for meticillin resistance in staphylococci and for vancomycin resistance in enterococci, which is of high importance for early adequate treatment. Both of the described methods were finally integrated into a protocol for fast and effective identification of bacteria from positive blood cultures.

Diagnostic Accuracy of MRI-guided Percutaneous Transthoracic Needle Biopsy of Solitary Pulmonary Nodules

DOE Office of Scientific and Technical Information (OSTI.GOV)

Liu, Shangang, E-mail: 1198685580@qq.com; Li, Chengli, E-mail: chenglilichina@yeah.net; Yu, Xuejuan, E-mail: yuxuejuan2011@126.com

2015-04-15

ObjectiveThe purpose of our study was to evaluate the diagnostic accuracy of MRI-guided percutaneous transthoracic needle biopsy (PTNB) of solitary pulmonary nodules (SPNs).MethodsRetrospective review of 69 patients who underwent MR-guided PTNB of SPNs was performed. Each case was reviewed for complications. The final diagnosis was established by surgical pathology of the nodule or clinical and imaging follow-up. Pneumothorax rate and diagnostic accuracy were compared between two groups according to nodule diameter (≤2 vs. >2 cm) using χ{sup 2} chest and Fisher’s exact test, respectively.ResultsThe success rate of single puncture was 95.6 %. Twelve (17.4 %) patients had pneumothorax, with 1 (1.4 %) requiring chestmore » tube insertion. Mild hemoptysis occurred in 7 (7.2 %) patients. All of the sample material was sufficient for histological diagnostic evaluation. Pathological analysis of biopsy specimens showed 46 malignant, 22 benign, and 1 nondiagnostic nodule. The final diagnoses were 49 malignant nodules and 20 benign nodules basing on postoperative histopathology and clinical follow-up data. One nondiagnostic sample was excluded from calculating diagnostic performance. A sensitivity, specificity, accuracy, positive predictive value, and negative predictive value in diagnosing SPNs were 95.8, 100, 97.0, 100, and 90.9 %, respectively. Pneumothorax rate, diagnostic sensitivity, and accuracy were not significantly different between the two groups (P > 0.05).ConclusionsMRI-guided PTNB is safe, feasible, and high accurate diagnostic technique for pathologic diagnosis of pulmonary nodules.« less

APPLICATION OF ISOTOPE ENCEPHALOGRAPHY AND ELECTROENCEPHALOSCOPY FOR LOCALIZATION OF BRAIN TUMOURS

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shamov, V.N.; Badmayev, C.N.; Bekhtereva, N.P.

1959-10-31

The problems of diagnosis and localization of brain tumors in some cases present many difficulities and make the neurosurgeon seek for additional methods of investigation. In such circumstances usage of the tracer technique in diagnostics is of considerable help, as it has obvious advantages compared with other methods of investigation, such as safety, painlessness, non-traumatism, absence of undesirable after effects, accuracy, and relative simplicity. The present communication is based on the results of clinical observations on 150 patients with verified brain tumors. Analyses of the data show that the accuracy of the brain tumor localizations vary, depending upon the depthmore » of the tumor site and conceniration of labelled material in the area of tumor growth. The diagnostic value of the method is doubtful in cases of tumors of posterior fossa, base of the brain, or the lesions of median line. The application of isotope encephalography is successfully supplemented by the new method of investigations, i.e., electroencephaloscopy, which allows the localization of deeply set tumors. Possibilities and limitations of the method are discussed. It is concluded that the isotope encephalography and electroencephaloscopy represent very valuable diagnostic methods which alongside with other auxiliary methods are widely used in diagnosis of brain tumors. (C.H.)« less

The DSM diagnostic criteria for vaginismus.

PubMed

Binik, Yitzchak M

2010-04-01

Vaginal spasm has been considered the defining diagnostic characteristic of vaginismus for approximately 150 years. This remarkable consensus, based primarily on expert clinical opinion, is preserved in the DSM-IV-TR. The available empirical research, however, does not support this definition nor does it support the validity of the DSM-IV-TR distinction between vaginismus and dyspareunia. The small body of research concerning other possible ways or methods of diagnosing vaginismus is critically reviewed. Based on this review, it is proposed that the diagnoses of vaginismus and dyspareunia be collapsed into a single diagnostic entity called "genito-pelvic pain/penetration disorder." This diagnostic category is defined according to the following five dimensions: percentage success of vaginal penetration; pain with vaginal penetration; fear of vaginal penetration or of genito-pelvic pain during vaginal penetration; pelvic floor muscle dysfunction; medical co-morbidity.

77 FR 41188 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-12

... technological advances, such as new test methods and the electronic transmission of laboratory information... potential need for educational materials and resources for sites that test under a Provider-performed Microscopy Certificate; and the increased use of culture-independent microbiology diagnostics and the impact...

Advantages of virulotyping foodborne pathogens over traditional identification and characterization methods

USDA-ARS?s Scientific Manuscript database

This chapter provides an overview regarding the advantages of virulotyping over historic serology-based, PCR-based on genes that identify an organism, or enzymatic and biochemical-based analyses of foodborne pathogens in clinical diagnostics and food industry microbiology testing. Traditional ident...

Diagnostic tools in maxillofacial fractures: Is there really a need of three-dimensional computed tomography?

PubMed Central

Shah, Sheerin; Uppal, Sanjeev K.; Mittal, Rajinder K.; Garg, Ramneesh; Saggar, Kavita; Dhawan, Rishi

2016-01-01

Introduction: Because of its functional and cosmetic importance, facial injuries, especially bony fractures are clinically very significant. Missed and maltreated fractures might result in malocclusion and disfigurement of the face, thus making accurate diagnosis of the fracture very essential. In earlier times, conventional radiography along with clinical examination played a major role in diagnosis of maxillofacial fractures. However, it was noted that the overlapping nature of bones and the inability to visualise soft tissue swelling and fracture displacement, especially in face, makes radiography less reliable and useful. Computed tomography (CT), also called as X-ray computed radiography, has helped in solving this problem. This clinical study is to compare three-dimensional (3D) CT reconstruction with conventional radiography in evaluating the maxillofacial fractures preoperatively and effecting the surgical management, accordingly. Materials and Methods: Fifty patients, with suspected maxillofacial fractures on clinical examination, were subjected to conventional radiography and CT face with 3D reconstruction. The number and site of fractures in zygoma, maxilla, mandible and nose, detected by both the methods, were enumerated and compared. The final bearing of these additional fractures, on the management protocol, was analysed. Results: CT proved superior to conventional radiography in diagnosing additional number of fractures in zygoma, maxilla, mandible (subcondylar) and nasal bone. Coronal and axial images were found to be significantly more diagnostic in fracture sites such as zygomaticomaxillary complex, orbital floor, arch, lateral maxillary wall and anterior maxillary wall. Conclusion: 3D images gave an inside out picture of the actual sites of fractures. It acted as mind's eye for pre-operative planning and intra-operative execution of surgery. Better surgical treatment could be given to 33% of the cases because of better diagnostic ability of CT. PMID:27833286

[Severity classification of chronic obstructive pulmonary disease based on deep learning].

PubMed

Ying, Jun; Yang, Ceyuan; Li, Quanzheng; Xue, Wanguo; Li, Tanshi; Cao, Wenzhe

2017-12-01

In this paper, a deep learning method has been raised to build an automatic classification algorithm of severity of chronic obstructive pulmonary disease. Large sample clinical data as input feature were analyzed for their weights in classification. Through feature selection, model training, parameter optimization and model testing, a classification prediction model based on deep belief network was built to predict severity classification criteria raised by the Global Initiative for Chronic Obstructive Lung Disease (GOLD). We get accuracy over 90% in prediction for two different standardized versions of severity criteria raised in 2007 and 2011 respectively. Moreover, we also got the contribution ranking of different input features through analyzing the model coefficient matrix and confirmed that there was a certain degree of agreement between the more contributive input features and the clinical diagnostic knowledge. The validity of the deep belief network model was proved by this result. This study provides an effective solution for the application of deep learning method in automatic diagnostic decision making.

[Cholera in pediatrics].

PubMed

Lezama-Basulto, L A; Mota-Hernández, F

1993-09-01

Cholerae is a grave and acute bacterial intestine infection which is caused by a bacilo, V. cholerae 01, that produces toxic products. Its clinical symptoms range from abundant liquid diarrhoea combined with vomiting and rapid dehydration. It is highly lethal when right treatment is not applied. There are also cases of cholera where victims do not show any symptoms of it, that is asymptomatic carriers. Any clinical suspicion of cholerae has to be corroborated by epidemiological data and its diagnostic confirmation should be done by isolating the bacteria, V. cholerae. When beginning the treatment, it is not necessary to confirm the diagnostic and this is based on the restitution of the liquids lost through vomiting and facing using any methods that are recommended for any other type of diarrhoea. The antimicrobial treatment is used only for grave cases. This present revision includes recent knowledge about cholerae emphasising on the effective management of cases through an adequate use of right treatment methods and also using the principal prevention measures against dissemination of this disease.

Diagnosing cystic fibrosis-related diabetes: current methods and challenges.

PubMed

Prentice, Bernadette; Hameed, Shihab; Verge, Charles F; Ooi, Chee Y; Jaffe, Adam; Widger, John

2016-07-01

Cystic fibrosis-related diabetes (CFRD) is the end-point of a spectrum of glucose abnormalities in cystic fibrosis that begins with early insulin deficiency and ultimately results in accelerated nutritional decline and loss of lung function. Current diagnostic and management regimens are unable to entirely reverse this clinical decline. This review summarises the current understanding of the pathophysiology of CFRD, the issues associated with using oral glucose tolerance tests in CF and the challenges faced in making the diagnosis of CFRD. Medline database searches were conducted using search terms "Cystic Fibrosis Related Diabetes", "Cystic Fibrosis" AND "glucose", "Cystic Fibrosis" AND "insulin", "Cystic Fibrosis" AND "Diabetes". Additionally, reference lists were studied. Expert commentary: Increasing evidence points to early glucose abnormalities being clinically relevant in cystic fibrosis and as such novel diagnostic methods such as continuous glucose monitoring or 30 minute sampled oral glucose tolerance test (OGTT) may play a key role in the future in the screening and diagnosis of early glucose abnormalities in CF.

Leveling the Playing Field: Bringing Development of Biomarkers and Molecular Diagnostics up to the Standards for Drug Development

PubMed Central

Poste, George; Carbone, David P.; Parkinson, David R.; Verweij, Jaap; Hewitt, Stephen; Jessup, J. Milburn

2012-01-01

Molecular diagnostics are increasingly important in clinical research to stratify or identify molecularly profiled patient cohorts for targeted therapies, to modify the dose of a therapeutic, or to assess early response to therapy or monitor patients. Molecular diagnostics can also be used to identify pharmocogenetic risk of adverse drug reactions. The articles of this CCR Focus section on Molecular Diagnosis describe the development and use of markers for medical decision-making in the cancer patient. They define the sources of preanalytic variability to minimize as well as the regulatory and financial challenges in diagnostic development and integration into clinical practice. They also outline an NCI program to assist diagnostic development. Molecular diagnostic clinical tests require rigor in their development and clinical validation with sufficient sensitivity, specificity and validity that is comparable to that used for development of therapeutics. These diagnostics must be offered at a realistic cost that reflects both their clinical value and the costs associated with their development. When genome sequencing technologies move into the clinic, they must be integrated with and traceable to current technology because they may identify more efficient and accurate approaches to drug development. In addition, regulators may define progressive drug approval for companion diagnostics that requires further evidence regarding efficacy and safety before full approval. A way to accomplish this is to emphasize Phase IV post-marketing hypothesis driven clinical trials with biological characterization that permits accurate definition of the association of low prevalence gene alterations with toxicity or response in large cohorts. PMID:22422403