Clinical utility and validity of minoxidil response testing in androgenetic alopecia.

PubMed

Goren, Andy; Shapiro, Jerry; Roberts, Janet; McCoy, John; Desai, Nisha; Zarrab, Zoulikha; Pietrzak, Aldona; Lotti, Torello

2015-01-01

Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3-6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patient's response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA. © 2014 Wiley Periodicals, Inc.

[Static posturography versus clinical tests in elderly people with vestibular pathology].

PubMed

Ortuño-Cortés, Miguel A; Martín-Sanz, Eduardo; Barona-de Guzmán, Rafael

2008-01-01

Balance can be quantified by clinical tests and through instrumental studies. The objective of this paper is to determine the correlation between static posturography and 4 clinical tests of balance in elderly people with vestibular disorders and to identify its capability to discriminate the groups studied. 60 patients with vestibular disorders and 60 healthy subjects performed 4 clinical tests (one leg standing with opened eyes, Timed Up and Go, Tinetti and Berg tests) and a static posturography analysis (NedSVE/IBV system) under 4 conditions: Romberg Test, Eyes Open (REO), Romberg Test, Eyes Closed (REC), Romberg Test on Foam with Eyes Open (RFEO), and Romberg Test on Foam with Eyes Closed (RFEC). RFEO correlated best with the clinical tests and RFEC was the worst. RFEO distinguished between healthy individuals and decompensated patients. RFEO gave the best information about postural balance in the elderly. RFEC was not useful. Static posturography can be useful to distinguish vestibular compensation status.

Linkage to care following community-based mobile HIV testing compared with clinic-based testing in Umlazi Township, Durban, South Africa.

PubMed

Bassett, I V; Regan, S; Luthuli, P; Mbonambi, H; Bearnot, B; Pendleton, A; Robine, M; Mukuvisi, D; Thulare, H; Walensky, R P; Freedberg, K A; Losina, E; Mhlongo, B

2014-07-01

The aim of the study was to assess HIV prevalence, disease stage and linkage to HIV care following diagnosis at a mobile HIV testing unit, compared with results for clinic-based testing, in a Durban township. This was a prospective cohort study. We enrolled adults presenting for HIV testing at a community-based mobile testing unit (mobile testers) and at an HIV clinic (clinic testers) serving the same area. Testers diagnosed with HIV infection, regardless of testing site, were offered immediate CD4 testing and instructed to retrieve results at the clinic. We assessed rates of linkage to care, defined as CD4 result retrieval within 90 days of HIV diagnosis and/or completion of antiretroviral therapy (ART) literacy training, for mobile vs. clinic testers. From July to November 2011, 6957 subjects were HIV tested (4703 mobile and 2254 clinic); 55% were female. Mobile testers had a lower HIV prevalence than clinic testers (10% vs. 36%, respectively), were younger (median 23 vs. 27 years, respectively) and were more likely to live >5 km or >30 min from the clinic (64% vs. 40%, respectively; all P < 0.001). Mobile testers were less likely to undergo CD4 testing (33% vs. 83%, respectively) but more likely to have higher CD4 counts [median (interquartile range) 416 (287-587) cells/μL vs. 285 (136-482) cells/μL, respectively] than clinic testers (both P < 0.001). Of those who tested HIV positive, 10% of mobile testers linked to care, vs. 72% of clinic testers (P < 0.001). Mobile HIV testing reaches people who are younger, who are more geographically remote, and who have earlier disease compared with clinic-based testing. Fewer mobile testers underwent CD4 testing and linked to HIV care. Enhancing linkage efforts may improve the impact of mobile testing for those with early HIV disease. © 2013 British HIV Association.

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

Review of the Reported Measures of Clinical Validity and Clinical Utility as Arguments for the Implementation of Pharmacogenetic Testing: A Case Study of Statin-Induced Muscle Toxicity.

PubMed

Jansen, Marleen E; Rigter, T; Rodenburg, W; Fleur, T M C; Houwink, E J F; Weda, M; Cornel, Martina C

2017-01-01

Advances from pharmacogenetics (PGx) have not been implemented into health care to the expected extent. One gap that will be addressed in this study is a lack of reporting on clinical validity and clinical utility of PGx-tests. A systematic review of current reporting in scientific literature was conducted on publications addressing PGx in the context of statins and muscle toxicity. Eighty-nine publications were included and information was selected on reported measures of effect, arguments, and accompanying conclusions. Most authors report associations to quantify the relationship between a genetic variation an outcome, such as adverse drug responses. Conclusions on the implementation of a PGx-test are generally based on these associations, without explicit mention of other measures relevant to evaluate the test's clinical validity and clinical utility. To gain insight in the clinical impact and select useful tests, additional outcomes are needed to estimate the clinical validity and utility, such as cost-effectiveness.

Does Pharmacogenomic Testing Improve Clinical Outcomes for Major Depressive Disorder? A Systematic Review of Clinical Trials and Cost-Effectiveness Studies.

PubMed

Rosenblat, Joshua D; Lee, Yena; McIntyre, Roger S

2017-06-01

Pharmacogenomic testing has become scalable and available to the general public. Pharmacogenomics has shown promise for predicting antidepressant response and tolerability in the treatment of major depressive disorder (MDD). In theory, pharmacogenomics can improve clinical outcomes by guiding antidepressant selection and dosing. The current systematic review examines the extant literature to determine the impact of pharmacogenomic testing on clinical outcomes in MDD and assesses its cost-effectiveness. The MEDLINE/PubMed and Google Scholar databases were systematically searched for relevant articles published prior to October 2015. Search terms included various combinations of the following: major depressive disorder (MDD), depression, mental illness, mood disorder, antidepressant, response, remission, outcome, pharmacogenetic, pharmacogenomics, pharmacodynamics, pharmacokinetic, genetic testing, genome wide association study (GWAS), CYP450, personalized medicine, cost-effectiveness, and pharmacoeconomics. Of the 66 records identified from the initial search, relevant clinical studies, written in English, assessing the cost-effectiveness and/or efficacy of pharmacogenomic testing for MDD were included. Each publication was critically examined for relevant data. Two nonrandomized, open-label, 8-week, prospective studies reported overall greater improvement in depressive symptom severity in the group of MDD subjects receiving psychiatric care guided by results of combinatorial pharmacogenomic testing (GeneSight) when compared to the unguided group. One industry-sponsored, randomized, double-blind, 10-week prospective study reported a trend for improved outcomes for the GeneSight-guided group; however, the trend did not reach statistical significance. Another industry-sponsored, randomized, double-blind, 12-week prospective study reported a 2.5-fold increase in remission rates in the CNSDose-guided group (P < .0001). One naturalistic, unblinded, industry-sponsored study showed clinical improvement when pharmacogenomics testing guided prescribing; however, this study lacked a control group. A single cost-effectiveness study concluded that single gene testing was not cost-effective. Conversely, a separate study reported that combinatorial pharmacogenomic testing is cost-effective. A limited number of studies have shown promise for the clinical utility of pharmacogenomic testing; however, cost-effectiveness of pharmacogenomics, as well as demonstration of improved health outcomes, is not yet supported with replicated evidence. © Copyright 2017 Physicians Postgraduate Press, Inc.

Chlamydia screening and prophylactic treatment in termination of pregnancy clinics in the Netherlands and Great Britain: a qualitative study.

PubMed

van den Berg, Georgina F; Picavet, Charles; Hoopman, Rianne; Lohr, Patricia A; Op de Coul, Eline L M

2016-12-01

Women having a termination of pregnancy (TOP) have higher rates of Chlamydia trachomatis (CT) than the general population. In this study, we explored CT treatment and prevention in Dutch TOP clinics in comparison to that provided in Great Britain (GB). A qualitative study including 14 semi-structured interviews with health care professionals (HCPs) in TOP clinics (the Netherlands: 9, GB: 5). Interviews were recorded, transcribed, and analysed by thematic content analysis. Prophylactic treatment with azithromycin is routinely prescribed after surgical TOP, but not after medical TOP ('abortion pill'). Sexually transmitted infections (STI) tests are offered to clients who are considered at high risk of having STI. Uptake varies according to health insurance coverage of STI testing. Some Dutch clinics are able to provide free testing for women under 25 years of age. Sexual health counselling is often limited to discussing birth control. The major difference between the Netherlands and GB is that GB TOP clinics more often offer free STI testing and prophylaxis to their clients. HCPs in Dutch TOP clinics consider STI testing an important part of their service, but financial barriers prevent testing on location. Dutch TOP clinics should offer STI tests to all women, and collaboration with public health services could improve STI testing and counselling for young people. Furthermore, clinics should treat all TOP clients with prophylactic azithromycin. This could prevent CT and other upper genital tract post-abortion infections.

VALIDATION OF A CLINICAL ASSESSMENT OF SPECTRAL RIPPLE RESOLUTION FOR COCHLEAR-IMPLANT USERS

PubMed Central

Drennan, Ward. R.; Anderson, Elizabeth S.; Won, Jong Ho; Rubinstein, Jay T.

2013-01-01

Objectives Non-speech psychophysical tests of spectral resolution, such as the spectral-ripple discrimination task, have been shown to correlate with speech recognition performance in cochlear implant (CI) users (Henry et al., 2005; Won et al. 2007, 2011; Drennan et al. 2008; Anderson et al. 2011). However, these tests are best suited for use in the research laboratory setting and are impractical for clinical use. A test of spectral resolution that is quicker and could more easily be implemented in the clinical setting has been developed. The objectives of this study were 1) To determine if this new clinical ripple test would yield individual results equivalent to the longer, adaptive version of the ripple discrimination test; 2) To evaluate test-retest reliability for the clinical ripple measure; and 3) To examine the relationship between clinical ripple performance and monosyllabic word recognition in quiet for a group of CI listeners. Design Twenty-eight CI recipients participated in the study. Each subject was tested on both the adaptive and the clinical versions of spectral ripple discrimination, as well as CNC word recognition in quiet. The adaptive version of spectral ripple employed a 2-up, 1-down procedure for determining spectral ripple discrimination threshold. The clinical ripple test used a method of constant stimuli, with trials for each of 12 fixed ripple densities occurring six times in random order. Results from the clinical ripple test (proportion correct) were then compared to ripple discrimination thresholds (in ripples per octave) from the adaptive test. Results The clinical ripple test showed strong concurrent validity, evidenced by a good correlation between clinical ripple and adaptive ripple results (r=0.79), as well as a correlation with word recognition (r = 0.7). Excellent test-retest reliability was also demonstrated with a high test-retest correlation (r = 0.9). Conclusions The clinical ripple test is a reliable non-linguistic measure of spectral resolution, optimized for use with cochlear implant users in a clinical setting. The test might be useful as a diagnostic tool or as a possible surrogate outcome measure for evaluating treatment effects in hearing. PMID:24552679

Are medical students being taught anatomy in a way that best prepares them to be a physician?

PubMed

Meral Savran, Mona; Tranum-Jensen, Jørgen; Frost Clementsen, Paul; Hastrup Svendsen, Jesper; Holst Pedersen, Jesper; Seier Poulsen, Steen; Arendrup, Henrik; Konge, Lars

2015-07-01

Reasoning in a clinical context is an attribute of medical expertise. Clinical reasoning in medical school can be encouraged by teaching basic science with a clinical emphasis. The aim of this study was to investigate whether anatomy is being taught in a way that facilitates the development of clinical reasoning. Two multiple-choice tests on thoracic anatomy were developed using a modified Delphi approach with groups of four clinical consultants and four teachers, respectively, expressing their opinions about knowledge relevant to thoracic anatomy. Validity was assessed by administering the tests to clinical consultants, anatomy teachers, and pre-course medical students. Post-course medical students took both tests to explore the focus of the course, i.e., whether it facilitated clinical reasoning. The pre-course students scored significantly lower than the teachers and post-course students on both tests and lower than the consultants on the consultants' test (P < 0.001 for all comparisons). The teachers significantly outperformed the consultants (P = 0.03 on the consultants' test, P < 0.001 on the teachers' test) and the medical students (P < 0.001 on both tests). The post-course students scored significantly lower on the consultants' test (P = 0.001) and significantly higher on the teachers' test (P = 0.02) than the consultants. This study demonstrates poor performances by medical students on a test containing clinically relevant anatomy, implying that the teaching they have received has not encouraged clinical reasoning. © 2015 Wiley Periodicals, Inc.

Improving clinical cognitive testing

PubMed Central

Gale, Seth A.; Barrett, A.M.; Boeve, Bradley F.; Chatterjee, Anjan; Coslett, H. Branch; D'Esposito, Mark; Finney, Glen R.; Gitelman, Darren R.; Hart, John J.; Lerner, Alan J.; Meador, Kimford J.; Pietras, Alison C.; Voeller, Kytja S.; Kaufer, Daniel I.

2015-01-01

Objective: To evaluate the evidence basis of single-domain cognitive tests frequently used by behavioral neurologists in an effort to improve the quality of clinical cognitive assessment. Methods: Behavioral Neurology Section members of the American Academy of Neurology were surveyed about how they conduct clinical cognitive testing, with a particular focus on the Neurobehavioral Status Exam (NBSE). In contrast to general screening cognitive tests, an NBSE consists of tests of individual cognitive domains (e.g., memory or language) that provide a more comprehensive diagnostic assessment. Workgroups for each of 5 cognitive domains (attention, executive function, memory, language, and spatial cognition) conducted evidence-based reviews of frequently used tests. Reviews focused on suitability for office-based clinical practice, including test administration time, accessibility of normative data, disease populations studied, and availability in the public domain. Results: Demographic and clinical practice data were obtained from 200 respondents who reported using a wide range of cognitive tests. Based on survey data and ancillary information, between 5 and 15 tests in each cognitive domain were reviewed. Within each domain, several tests are highlighted as being well-suited for an NBSE. Conclusions: We identified frequently used single-domain cognitive tests that are suitable for an NBSE to help make informed choices about clinical cognitive assessment. Some frequently used tests have limited normative data or have not been well-studied in common neurologic disorders. Utilizing standardized cognitive tests, particularly those with normative data based on the individual's age and educational level, can enhance the rigor and utility of clinical cognitive assessment. PMID:26163433

Successive potassium hydroxide testing for improved diagnosis of tinea pedis.

PubMed

Karaman, Bilge F; Topal, Suhan G; Aksungur, Varol L; Ünal, İlker; İlkit, Macit

2017-08-01

In this study, we investigated the role of successive potassium hydroxide (KOH) tests for the diagnosis of tinea pedis with different clinical presentations. The study included 135 patients with 200 lesions that were clinically suspicious for tinea pedis. Three samples of skin scrapings were taken from each lesion in the same session and were examined using a KOH test. This study offers an inexpensive, rapid, and useful technique for the daily practice of clinicians and mycologists managing patients with clinically suspected tinea pedis.

Clinical evidence supporting pharmacogenomic biomarker testing provided in US Food and Drug Administration drug labels.

PubMed

Wang, Bo; Canestaro, William J; Choudhry, Niteesh K

2014-12-01

Genetic biomarkers that predict a drug's efficacy or likelihood of toxicity are assuming increasingly important roles in the personalization of pharmacotherapy, but concern exists that evidence that links use of some biomarkers to clinical benefit is insufficient. Nevertheless, information about the use of biomarkers appears in the labels of many prescription drugs, which may add confusion to the clinical decision-making process. To evaluate the evidence that supports pharmacogenomic biomarker testing in drug labels and how frequently testing is recommended. Publicly available US Food and Drug Administration databases. We identified drug labels that described the use of a biomarker and evaluated whether the label contained or referenced convincing evidence of its clinical validity (ie, the ability to predict phenotype) and clinical utility (ie, the ability to improve clinical outcomes) using guidelines published by the Evaluation of Genomic Applications in Practice and Prevention Working Group. We graded the completeness of the citation of supporting studies and determined whether the label recommended incorporation of biomarker test results in therapeutic decision making. Of the 119 drug-biomarker combinations, only 43 (36.1%) had labels that provided convincing clinical validity evidence, whereas 18 (15.1%) provided convincing evidence of clinical utility. Sixty-one labels (51.3%) made recommendations about how clinical decisions should be based on the results of a biomarker test; 36 (30.3%) of these contained convincing clinical utility data. A full description of supporting studies was included in 13 labels (10.9%). Fewer than one-sixth of drug labels contained or referenced convincing evidence of clinical utility of biomarker testing, whereas more than half made recommendations based on biomarker test results. It may be premature to include biomarker testing recommendations in drug labels when convincing data that link testing to patient outcomes do not exist.

Are reports of cognitive testing among older electroconvulsive therapy recipients clinically valid?

PubMed

Plakiotis, Chris; Chin, Loi Fei; O'Connor, Daniel W

2014-03-01

Electroconvulsive therapy (ECT) administration rises in frequency with age, with older depressed adults often showing clinical features predictive of good response. Recent reviews suggest that older people experience few if any long-term cognitive adverse effects after contemporary ECT, despite their increased vulnerability to these. However, the broader clinical validity of research findings is not assured as most studies of ECT-related cognitive effects do not discuss cognitive test nonparticipants. This study examines whether cognitive test participants and nonparticipants are comparable. We recently completed a study of cognition in depressed patients 65 years and older treated with ECT. Only 35% of eligible patients completed neuropsychological testing at 2 time points, the remainder either refusing or unable to consent. To examine whether exclusion of most eligible patients from cognitive testing might have affected the clinical applicability of findings, we compared demographic and clinical characteristics of patients who participated with those who did not based on a subset of patients from our original study. The 2 patient groups differed in several respects. Most notably, nonparticipants were significantly more likely to be involuntary patients; to refuse food and fluids; and to require treatment with a bitemporal or mixed electrode placement. Our findings suggest cognitive test nonparticipants to be more severely psychiatrically unwell than test participants. As their exclusion might bias results and confound understanding of this important ECT-related topic, special mention of participation rates and comparison of participants and nonparticipants is recommended to establish the clinical relevance of future study findings.

Preclinical to Clinical Translation of Studies of Transcranial Direct-Current Stimulation in the Treatment of Epilepsy: A Systematic Review

PubMed Central

Regner, Gabriela G.; Pereira, Patrícia; Leffa, Douglas T.; de Oliveira, Carla; Vercelino, Rafael; Fregni, Felipe; Torres, Iraci L. S.

2018-01-01

Epilepsy is a chronic brain syndrome characterized by recurrent seizures resulting from excessive neuronal discharges. Despite the development of various new antiepileptic drugs, many patients are refractory to treatment and report side effects. Non-invasive methods of brain stimulation, such as transcranial direct current stimulation (tDCS), have been tested as alternative approaches to directly modulate the excitability of epileptogenic neural circuits. Although some pilot and initial clinical studies have shown positive results, there is still uncertainty regarding the next steps of investigation in this field. Therefore, we reviewed preclinical and clinical studies using the following framework: (1) preclinical studies that have been successfully translated to clinical studies, (2) preclinical studies that have failed to be translated to clinical studies, and (3) clinical findings that were not previously tested in preclinical studies. We searched PubMed, Web of Science, Embase, and SciELO (2002–2017) using the keywords “tDCS,” “epilepsy,” “clinical trials,” and “animal models.” Our initial search resulted in 64 articles. After applying inclusion and exclusion criteria, we screened 17 full-text articles to extract findings about the efficacy of tDCS, with respect to the therapeutic framework used and the resulting reduction in seizures and epileptiform patterns. We found that few preclinical findings have been translated into clinical research (number of sessions and effects on seizure frequency) and that most findings have not been tested clinically (effects of tDCS on status epilepticus and absence epilepsy, neuroprotective effects in the hippocampus, and combined use with specific medications). Finally, considering that clinical studies on tDCS have been conducted for several epileptic syndromes, most were not previously tested in preclinical studies (Rasmussen's encephalitis, drug resistant epilepsy, and hippocampal sclerosis-induced epilepsy). Overall, most studies report positive findings. However, it is important to underscore that a successful preclinical study may not indicate success in a clinical study, considering the differences highlighted herein. Although most studies report significant findings, there are still important insights from preclinical work that must be tested clinically. Understanding these factors may improve the evidence for the potential use of this technique as a clinical tool in the treatment of epilepsy. PMID:29623027

Pathways from Autism Spectrum Disorder (ASD) Diagnosis to Genetic Testing

PubMed Central

Barton, Krysta S.; Tabor, Holly K.; Starks, Helene; Garrison, Nanibaa’ A.; Laurino, Mercy; Burke, Wylie

2017-01-01

Purpose This study examines challenges faced by families and health providers related to genetic testing for autism spectrum disorder (ASD). Methods This qualitative study of 14 parents and 15 health providers identified an unstandardized three-step process for families who pursue ASD genetic testing. Results Step 1 is the clinical diagnosis of ASD, confirmed by providers practicing alone or in a team. Step 2 is the offer of genetic testing to find an etiology. For those offered testing, step 3 involves the parents’ decision whether to pursue testing. Despite professional guidelines and recommendations, interviews describe considerable variability in approaches to genetic testing for ASD, a lack of consensus among providers, and questions about clinical utility. Many families in our study were unaware of the option for genetic testing; testing decisions by parents appear to be influenced by both provider recommendations and insurance coverage. Conclusion Consideration of genetic testing for ASD should take into account different views about the clinical utility of testing and variability in insurance coverage. Ideally, policy makers from the range of clinical specialties involved in ASD care should revisit policies to clarify the purpose of genetic testing for ASD and promote consensus about its appropriate use. PMID:29048417

Interexaminer reliability in physical examination of patients with low back pain.

PubMed

Strender, L E; Sjöblom, A; Sundell, K; Ludwig, R; Taube, A

1997-04-01

Seventy-one patients with low back pain were examined by two physiotherapists (50 patients) and two physicians (21 patients). The two physiotherapists had worked together for many years, but the two physicians had not. The interexaminer reliability of the clinical tests included in the physical examination was evaluated. To evaluate the interexaminer reliability of clinical tests used in the physical examination of patients with low back pain under ideal circumstances, which was the case for the physiotherapists. Numerous clinical tests are used in the evaluation of patients with low back pain. To reach the correct diagnosis, only tests with an acceptable validity and reliability should be used. Previous studies have mainly shown low reliability. It is important that clinical tests not be rejected because of low reliability caused by differences between examiners in performance of the examination and in their definition of normal results. Two examiners, either two physiotherapists or two physicians, independently examined patients with low back pain. In approximately half of the clinical tests studied, an acceptable reliability was demonstrated. On the basis of the physiotherapists series, the reliability was acceptable for a number of clinical tests that are used in the evaluation of patients with low back pain. The results suggest that clinical tests should be standardized to a much higher degree than they are today.

Lyme disease testing in children in an endemic area.

PubMed

Al-Sharif, Bashar; Hall, Matthew C

2011-10-01

The purpose of this study was to determine clinician adherence to recommendations regarding diagnostic testing for Lyme disease (LD). The specific aims were to determine the rate of inappropriate test ordering for a diagnosis of erythema migrans and tack of confirmatory test ordering for positive LD screening tests. Using the data warehouse of Marshfield Clinic Research Foundation's Bioinformatics Research Center, cases were identified from 2002 through 2007. A retrospective chart abstraction was performed using Marshfield Clinic's electronic medical record. The study involved children (<19 years old). In 57% of cases, LD testing occurred after a clinical diagnosis of erythema migrans was made. Patients with any symptom in addition to erythema migrans were more likely to have testing (odds ratio (OR) = 3.52, 1.75-7.08). A positive LD screening test was not confirmed 24% of the time. Lack of ordering confirmatory testing was not associated with any clinical factors or site of the evaluation. This study found that some clinicians in an LD-endemic area do not follow guidelines for diagnosing children suspected to have Lyme disease.

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

PubMed Central

Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa.

PubMed

Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E

2008-06-01

To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.

How can point-of-care HbA1c testing be integrated into UK primary care consultations? - A feasibility study.

PubMed

Hirst, J A; Stevens, R J; Smith, I; James, T; Gudgin, B C; Farmer, A J

2017-08-01

Point-of-care (POC) HbA1c testing gives a rapid result, allowing testing and treatment decisions to take place in a single appointment. Trials of POC testing have not been shown to improve HbA1c, possibly because of how testing was implemented. This study aimed to identify key components of POC HbA1c testing and determine strategies to optimise implementation in UK primary care. This cohort feasibility study recruited thirty patients with type 2 diabetes and HbA1c>7.5% (58mmol/mol) into three primary care clinics. Patients' clinical care included two POC HbA1c tests over six months. Data were collected on appointment duration, clinical decisions, technical performance and patient behaviour. Fifty-three POC HbA1c consultations took place during the study; clinical decisions were made in 30 consultations. Five POC consultations with a family doctor lasted on average 11min and 48 consultations with nurses took on average 24min. Five POC study visits did not take place in one clinic. POC results were uploaded to hospital records from two clinics. In total, sixty-three POC tests were performed, and there were 11 cartridge failures. No changes in HbA1c or patient behaviour were observed. HbA1c measurement with POC devices can be effectively implemented in primary care. This work has identified when these technologies might work best, as well as potential challenges. The findings can be used to inform the design of a pragmatic trial to implement POC HbA1c testing. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Lifestyle and Clinical Health Behaviors and PSA Tests

ERIC Educational Resources Information Center

Norris, Cynthia; McFall, Stephanie

2006-01-01

This study assessed the association of lifestyle and clinical health behaviors with prostate specific antigen (PSA) tests. The study used cross-sectional data from the 2002 Behavioral Risk Factor Surveillance System (BRFSS). We used Stata 8.0 to take into account the complex sample design in analyses. Both lifestyle and clinical health behaviors…

Improving clinical cognitive testing: report of the AAN Behavioral Neurology Section Workgroup.

PubMed

Daffner, Kirk R; Gale, Seth A; Barrett, A M; Boeve, Bradley F; Chatterjee, Anjan; Coslett, H Branch; D'Esposito, Mark; Finney, Glen R; Gitelman, Darren R; Hart, John J; Lerner, Alan J; Meador, Kimford J; Pietras, Alison C; Voeller, Kytja S; Kaufer, Daniel I

2015-09-08

To evaluate the evidence basis of single-domain cognitive tests frequently used by behavioral neurologists in an effort to improve the quality of clinical cognitive assessment. Behavioral Neurology Section members of the American Academy of Neurology were surveyed about how they conduct clinical cognitive testing, with a particular focus on the Neurobehavioral Status Exam (NBSE). In contrast to general screening cognitive tests, an NBSE consists of tests of individual cognitive domains (e.g., memory or language) that provide a more comprehensive diagnostic assessment. Workgroups for each of 5 cognitive domains (attention, executive function, memory, language, and spatial cognition) conducted evidence-based reviews of frequently used tests. Reviews focused on suitability for office-based clinical practice, including test administration time, accessibility of normative data, disease populations studied, and availability in the public domain. Demographic and clinical practice data were obtained from 200 respondents who reported using a wide range of cognitive tests. Based on survey data and ancillary information, between 5 and 15 tests in each cognitive domain were reviewed. Within each domain, several tests are highlighted as being well-suited for an NBSE. We identified frequently used single-domain cognitive tests that are suitable for an NBSE to help make informed choices about clinical cognitive assessment. Some frequently used tests have limited normative data or have not been well-studied in common neurologic disorders. Utilizing standardized cognitive tests, particularly those with normative data based on the individual's age and educational level, can enhance the rigor and utility of clinical cognitive assessment. © 2015 American Academy of Neurology.

A literature review of clinical tests for lumbar instability in low back pain: validity and applicability in clinical practice.

PubMed

Ferrari, Silvano; Manni, Tiziana; Bonetti, Francesca; Villafañe, Jorge Hugo; Vanti, Carla

2015-01-01

Several clinical tests have been proposed on low back pain (LBP), but their usefulness in detecting lumbar instability is not yet clear. The objective of this literature review was to investigate the clinical validity of the main clinical tests used for the diagnosis of lumbar instability in individuals with LBP and to verify their applicability in everyday clinical practice. We searched studies of the accuracy and/or reliability of Prone Instability Test (PIT), Passive Lumbar Extension Test (PLE), Aberrant Movements Pattern (AMP), Posterior Shear Test (PST), Active Straight Leg Raise Test (ASLR) and Prone and Supine Bridge Tests (PB and SB) in Medline, Embase, Cinahl, PubMed, and Scopus databases. Only the studies in which each test was investigated by at least one study concerning both the accuracy and the reliability were considered eligible. The quality of the studies was evaluated by QUADAS and QAREL scales. Six papers considering 333 LBP patients were included. The PLE was the most accurate and informative clinical test, with high sensitivity (0.84, 95% CI: 0.69 - 0.91) and high specificity (0.90, 95% CI: 0.85 -0.97). The diagnostic accuracy of AMP depends on each singular test. The PIT and the PST demonstrated by fair to moderate sensitivity and specificity [PIT sensitivity = 0.71 (95% CI: 0.51 - 0.83), PIT specificity = 0.57 (95% CI: 039 - 0.78); PST sensitivity = 0.50 (95% CI: 0.41 - 0.76), PST specificity = 0.48 (95% CI: 0.22 - 0.58)]. The PLE showed a good reliability (k = 0.76), but this result comes from a single study. The inter-rater reliability of the PIT ranged by slight (k = 0.10 and 0.04), to good (k = 0.87). The inter-rater reliability of the AMP ranged by slight (k = -0.07) to moderate (k = 0.64), whereas the inter-rater reliability of the PST was fair (k = 0.27). The data from the studies provided information on the methods used and suggest that PLE is the most appropriate tests to detect lumbar instability in specific LBP. However, due to the lack of available papers on other lumbar conditions, these findings should be confirmed with studies on non-specific LBP patients.

Diagnostic value of the basophil activation test in evaluating Hymenoptera venom sensitization.

PubMed

Peternelj, Andreja; Silar, Mira; Bajrovic, Nissera; Adamic, Katja; Music, Ema; Kosnik, Mitja; Korosec, Peter

2009-01-01

Diagnosis of allergy to Hymenoptera venom is usually confirmed with skin testing and measurement of specific serum IgE antibody, tests which are sometimes inconclusive. In these cases, additional in vitro tests are necessary. The aim of this study was to show the applicability of the basophil activation test in detecting sensitization to Hymenoptera venom and to compare the test sensitivity and clinical positive-predictive value with skin prick tests and measurement of allergen-specific serum IgE. This prospective study was conducted between June 2004 and December 2007 and included a large group of 204 patients. All patients had a history of at least one systemic allergic reaction of Müller grades II-IV after a Hymenoptera sting. We compared results of the basophil activation test, specific serum IgE and skin prick tests with patients' clinical history and data on culprit insects. The overall clinical sensitivities of the basophil activation test, specific serum IgE and skin prick tests were 90%, 76% and 64%, respectively; the clinical positive-predictive values of the three tests were 79%, 73% and 78% for bee venom, 86%, 59% and 43% for wasp venom; and 84%, 77% and 22% for both venoms. Our results revealed a higher clinical sensitivity and comparable or better clinical positive-predictive value of basophil activation tests than skin prick tests and allergen-specific serum IgE in the detection of allergy to Hymenoptera venom.

The Society for Translational Medicine: clinical practice guidelines for sperm DNA fragmentation testing in male infertility

PubMed Central

Cho, Chak-Lam; Majzoub, Ahmad; Esteves, Sandro C.

2017-01-01

Sperm DNA fragmentation (SDF) testing has been emerging as a valuable tool for male fertility evaluation. While the essential role of sperm DNA integrity in human reproduction was extensively studied, the clinical indication of SDF testing is less clear. This clinical practice guideline provides recommendations of clinical utility of the test supported by evidence. It is intended to serve as a reference for fertility specialists in identifying the circumstances in which SDF testing should be of greatest clinical value. SDF testing is recommended in patients with clinical varicocele and borderline to normal semen parameters as it can better select varicocelectomy candidates. Outcomes of natural pregnancy and assisted reproductive techniques (ART) can be predicted by result of SDF tests. High SDF is also linked with recurrent pregnancy loss (RPL) and failure of ART. Result of SDF testing may change the management decision by selecting the most appropriate ART with the highest success rate for infertile couples. Several studies have demonstrated the benefit in using testicular instead of ejaculated sperm in men with high SDF, oligozoospermia or recurrent in vitro fertilization (IVF) failure. Infertile men with modifiable lifestyle factor may benefit from SDF testing by reinforcing risk factor modification and monitoring patient’s progress to intervention. PMID:29082206

The views of genitourinary medicine (GUM) clinic users on unlinked anonymous testing for HIV: evidence from a pilot study of clinics in two English cities.

PubMed

Datta, Jessica; Kessel, Anthony; Wellings, Kaye; Nanchahal, Kiran; Marks, Dalya; Kinghorn, George

2011-11-01

A study was undertaken of the views of users of two genitourinary medicine (GUM) clinics in England on unlinked anonymous testing (UAT) for HIV. The UAT programme measures the prevalence of HIV in the population, including undiagnosed prevalence, by testing residual blood (from samples taken for clinical purposes) which is anonymised and irreversibly unlinked from the source. 424 clinic users completed an anonymous questionnaire about their knowledge of, and attitudes towards, UAT. Only 1/7 (14%) were aware that blood left over from clinical testing may be tested anonymously for HIV. A large majority (89%) said they would agree to their blood being tested, although 74% wanted the opportunity to consent. These findings indicate broad support for UAT of blood in a group of patients whose samples are included in the HIV surveillance programme. The findings suggest the need for greater attention to be given to the provision of information and, if replicated in a larger survey, may justify a reappraisal of UK policy on UAT.

The utility of pre-test clinical scoring for clinical diagnosis of heparin-induced thrombocytopenia in cardiac surgery patients of a tertiary care centre in north India.

PubMed

Sachan, D; Gupta, N; Agarwal, P; Chaudhary, R

2011-08-01

Heparin-induced thrombocytopenia (HIT) should be diagnosed clinically as well as by laboratory assays for timely recognition, prevention and management of complications. To evaluate the clinical utility of pre-test clinical scoring system in combination with two immunoassays for the diagnosis of HIT in cardiac surgery patients. A total of 100 consecutive patients undergoing cardiac surgery were studied. Pre-test clinical scoring was carried out in patients with thrombocytopenia and further tested by two immunoassays, i.e., Heparin platelet factor 4 (H-PF4) enzyme-linked immunosorbent assay (ELISA) and particle gel immunoassay (PaGIA). Of the 100 patients studied, 42 patients developed thrombocytopenia post-operatively. On pre-test clinical scoring, low T-score was observed in 6 patients, intermediate in 28 and high score in 8 patients, whereas 19 patients (45.2%) were positive by H-PF4 ELISA and 10 (23.8%) by PaGIA for H-PF4 antibody. The difference in the incidence of clinically significant HIT antibodies in the three categories was statistically significant. A good correlation was also observed with ELISA optical density, T-scoring and PaGIA. Pre-test clinical scoring correlates well with the development of H-PF4 antibodies which are incriminated in the causation of thrombotic complications in patients with HIT. We also propose a protocol for diagnosing patients with clinical suspicion of HIT using pre-test clinical scoring and immunoassay. © 2011 The Authors. Transfusion Medicine © 2011 British Blood Transfusion Society.

Effects of structured written feedback by cards on medical students' performance at Mini Clinical Evaluation Exercise (Mini-CEX) in an outpatient clinic.

PubMed

Haghani, Fariba; Hatef Khorami, Mohammad; Fakhari, Mohammad

2016-07-01

Feedback cards are recommended as a feasible tool for structured written feedback delivery in clinical education while effectiveness of this tool on the medical students' performance is still questionable.  The purpose of this study was to compare the effects of structured written feedback by cards as well as verbal feedback versus verbal feedback alone on the clinical performance of medical students at the Mini Clinical Evaluation Exercise (Mini-CEX) test in an outpatient clinic. This is a quasi-experimental study with pre- and post-test comprising four groups in two terms of medical students' externship. The students' performance was assessed through the Mini-Clinical Evaluation Exercise (Mini-CEX) as a clinical performance evaluation tool. Structured written feedbacks were given to two experimental groups by designed feedback cards as well as verbal feedback, while in the two control groups feedback was delivered verbally as a routine approach in clinical education. By consecutive sampling method, 62 externship students were enrolled in this study and seven students were excluded from the final analysis due to their absence for three days. According to the ANOVA analysis and Post Hoc Tukey test,  no statistically significant difference was observed among the four groups at the pre-test, whereas a statistically significant difference was observed between the experimental and control groups at the post-test  (F = 4.023, p =0.012). The effect size of the structured written feedbacks on clinical performance was 0.19. Structured written feedback by cards could improve the performance of medical students in a statistical sense. Further studies must be conducted in other clinical courses with longer durations.

[How good are clinical investigative procedures for diagnosing meniscus lesions?].

PubMed

Jerosch, J; Riemer, S

2004-06-01

The purpose of this study was to evaluate different clinical meniscus tests. During 13 months we evaluated 64 patients with a suspected meniscus lesion in a prospective study. The age ranged from 16 to 76 years (average: 38.5 years). 66 % were male patients. Between the clinical examination and the arthroscopy there was no additional trauma to the knee. All patients were clinically examined in a standard manner by two independent orthopaedic surgeons. Clinical findings of the menisci were documented according to 12 well-described and commonly used meniscus tests. The arthroscopy was performed by a single surgeon who was not aware of the results of the clinical examination. This surgeon documented the intraarticular findings in a standardized operating report. A meniscus lesion/degeneration was documented when this was evident either by inspection or by palpation. The results showed either clinical meniscus tests with a high specificity and a low sensitivity or tests with a high sensitivity, but only a low specificity. We were not able to identify meniscus tests which showed both a high sensitivity and a high specificity. Even with access to MRI the clinical findings in knee joint with injured menisci still have a high diagnostic value. However, it seems to be necessary to combine different tests.

Assessing Clinical Reasoning (ASCLIRE): Instrument Development and Validation

ERIC Educational Resources Information Center

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

2015-01-01

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…

Impact of environmental adaptation on tear film assessments.

PubMed

Fagehi, R

2018-03-01

The purpose of this study was to investigate the effect of ocular environmental adaptation on clinical tear film assessment. Thirty subjects (male, mean age 23±2.5) participated in this study. A number of clinical tear film tests were applied, including: fluorescein tear break-up time (FTBUT), Schirmer test and tear prism height test (TPH). The tear physiology of each subject was evaluated twice, once immediately when they arrived from the external environment, and then after 30minutes adaptation in the exam room environment. The mean values were: Schirmer test A (22.1±2.99), Schirmer test B (24.2±2.63), FTBUT A (8.00±1.94), FTBUT B (9.13±2.04), TPH A (0.179±0.026) and TPH B* (0.187±0.023). Statistical testing using Wilcoxon-signed rank test showed a significant difference between the Schirmer test results measured at the different times (P=0.008). Also, the FTBUT and tear prism height test results showed significant differences between the two evaluation times, (P=0.001, 0.011, respectively) (A: tear assessed when the subject comes from the outside environment, B: tear film assessed after 30min adaptation in the clinical environment). This study showed a significant difference between the tear film test results evaluated when the subjects were assessed immediately from the outside environment and after an adaptation time in the clinic environment. Practitioners must consider the effect of differences between external and clinical environment adaptation on clinical tear film physiology. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Ultrasound transducer function: annual testing is not sufficient.

PubMed

Mårtensson, Mattias; Olsson, Mats; Brodin, Lars-Åke

2010-10-01

The objective was to follow-up the study 'High incidence of defective ultrasound transducers in use in routine clinical practice' and evaluate if annual testing is good enough to reduce the incidence of defective ultrasound transducers in routine clinical practice to an acceptable level. A total of 299 transducers were tested in 13 clinics at five hospitals in the Stockholm area. Approximately 7000-15,000 ultrasound examinations are carried out at these clinics every year. The transducers tested in the study had been tested and classified as fully operational 1 year before and since then been in normal use in the routine clinical practice. The transducers were tested with the Sonora FirstCall Test System. There were 81 (27.1%) defective transducers found; giving a 95% confidence interval ranging from 22.1 to 32.1%. The most common transducer errors were 'delamination' of the ultrasound lens and 'break in the cable' which together constituted 82.7% of all transducer errors found. The highest error rate was found at the radiological clinics with a mean error rate of 36.0%. There was a significant difference in error rate between two observed ways the clinics handled the transducers. There was no significant difference in the error rates of the transducer brands or the transducers models. Annual testing is not sufficient to reduce the incidence of defective ultrasound transducers in routine clinical practice to an acceptable level and it is strongly advisable to create a user routine that minimizes the handling of the transducers.

Agreement between clinical and laboratory methods assessing tonic and cross-link components of accommodation and vergence.

PubMed

Neveu, Pascaline; Priot, Anne-Emmanuelle; Philippe, Matthieu; Fuchs, Philippe; Roumes, Corinne

2015-09-01

Several tests are available to optometrists for investigating accommodation and vergence. This study sought to investigate the agreement between clinical and laboratory methods and to clarify which components are actually measured when tonic and cross-link of accommodation and vergence are assessed. Tonic vergence, tonic accommodation, accommodative vergence (AC/A) and vergence accommodation (CA/C) were measured using several tests. Clinical tests were compared to the laboratory assessment, the latter being regarded as an absolute reference. The repeatability of each test and the degree of agreement between the tests were quantified using Bland-Altman analysis. The values obtained for each test were found to be stable across repetitions; however, in most cases, significant differences were observed between tests supposed to measure the same oculomotor component. Tonic and cross-link components cannot be easily assessed because proximal and instrumental responses interfere with the assessment. Other components interfere with oculomotor assessment. Specifically, accommodative divergence interferes with tonic vergence estimation and the type of accommodation considered in the AC/A ratio affects its magnitude. Results on clinical tonic accommodation and clinical CA/C show that further investigation is needed to clarify the limitations associated with the use of difference of Gaussian as visual targets to open the accommodative loop. Although different optometric tests of accommodation and vergence rely on the same basic principles, the results of this study indicate that clinical and laboratory methods actually involve distinct components. These differences, which are induced by methodological choices, must be taken into account, when comparing studies or when selecting a test to investigate a particular oculomotor component. © 2015 The Authors. Clinical and Experimental Optometry © 2015 Optometry Australia.

Responsiveness of clinical tests for people with neck pain.

PubMed

Jørgensen, René; Ris, Inge; Juhl, Carsten; Falla, Deborah; Juul-Kristensen, Birgit

2017-12-28

Responsiveness of a clinical test is highly relevant in order to evaluate the effect of a given intervention. However, the responsiveness of clinical tests for people with neck pain has not been adequately evaluated. The objective of the present study was to examine the responsiveness of four clinical tests which are low cost and easy to perform in a clinical setting, including the craniocervical flexion test, cervical active range of movement, test for the cervical extensors and pressure pain threshold testing. This study is a secondary analysis of data collected in a previously published randomised controlled trial. Participants were randomized to either physical training, exercises and pain education combined or pain education only. Participants were tested on the clinical tests at baseline and at 4-month follow-up. An anchor-based approach using Receiver Operator Characteristics (ROC) curves was used to evaluate responsiveness of the clinical tests. The Neck Disability Index was used to discriminate between those who had improved and those who were unchanged at the 4-month follow-up. Minimum Clinically Important Difference (MCID), together with sensitivity, specificity, positive and negative predictive values, in addition to positive and negative likelihood ratios were calculated. In total, 164 participants completed the 4 month follow up. One-hundred forty four participants were classified as unchanged whereas 20 patients were considered to be improved. Twenty-six participants didn't complete all of the clinical tests, leaving a total of 138 to be included for analyses. Area Under Curve (AUC) ranged from 0.50-0.62 for the clinical tests, and were all below an acceptable level. MCID was generally large, and the corresponding sensitivity and specificity was low with sensitivity ranging from 20 to 60%, and specificity from 54 to 86%. LR+ (0.8-2.07) and LR- (0.7-1.1) showed low diagnostic value for all variables, with PPV ranging from 12.1 to 26.1 and NPV ranging from 84.7 to 89.2. Responsiveness of the included clinical tests was generally low when using change in NDI score as the anchor from baseline to the 4-month follow up. Further investigations of responsiveness are warranted, possibly using other anchors, which to a higher degree resemble similar dimensions as the clinical tests.

Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials.

PubMed

Wu, Zhichao; Medeiros, Felipe A

2018-03-20

Visual field testing is an important endpoint in glaucoma clinical trials, and the testing paradigm used can have a significant impact on the sample size requirements. To investigate this, this study included 353 eyes of 247 glaucoma patients seen over a 3-year period to extract real-world visual field rates of change and variability estimates to provide sample size estimates from computer simulations. The clinical trial scenario assumed that a new treatment was added to one of two groups that were both under routine clinical care, with various treatment effects examined. Three different visual field testing paradigms were evaluated: a) evenly spaced testing, b) United Kingdom Glaucoma Treatment Study (UKGTS) follow-up scheme, which adds clustered tests at the beginning and end of follow-up in addition to evenly spaced testing, and c) clustered testing paradigm, with clusters of tests at the beginning and end of the trial period and two intermediary visits. The sample size requirements were reduced by 17-19% and 39-40% using the UKGTS and clustered testing paradigms, respectively, when compared to the evenly spaced approach. These findings highlight how the clustered testing paradigm can substantially reduce sample size requirements and improve the feasibility of future glaucoma clinical trials.

Effects of an intensive clinical skills course on senior nursing students' self-confidence and clinical competence: A quasi-experimental post-test study.

PubMed

Park, Soohyun

2018-02-01

To foster nursing professionals, nursing education requires the integration of knowledge and practice. Nursing students in their senior year experience considerable stress in performing the core nursing skills because, typically, they have limited opportunities to practice these skills in their clinical practicum. Therefore, nurse educators should revise the nursing curricula to focus on core nursing skills. To identify the effect of an intensive clinical skills course for senior nursing students on their self-confidence and clinical competence. A quasi-experimental post-test study. A university in South Korea during the 2015-2016 academic year. A convenience sample of 162 senior nursing students. The experimental group (n=79) underwent the intensive clinical skills course, whereas the control group (n=83) did not. During the course, students repeatedly practiced the 20 items that make up the core basic nursing skills using clinical scenarios. Participants' self-confidence in the core clinical nursing skills was measured using a 10-point scale, while their clinical competence with these skills was measured using the core clinical nursing skills checklist. Independent t-test and chi-square tests were used to analyze the data. The mean scores in self-confidence and clinical competence were higher in the experimental group than in the control group. This intensive clinical skills courses had a positive effect on senior nursing students' self-confidence and clinical competence for the core clinical nursing skills. This study emphasizes the importance of reeducation using a clinical skills course during the transition from student to nursing professional. Copyright © 2017. Published by Elsevier Ltd.

An observational study of the impact of genetic testing for pain perception in the clinical management of chronic non-cancer pain.

PubMed

Sharma, Maneesh; Kantorovich, Svetlana; Lee, Chee; Anand, Natasha; Blanchard, John; Fung, Eric T; Meshkin, Brian; Brenton, Ashley; Richeimer, Steven

2017-06-01

Pain levels are a key metric in clinical care. However, the assessment of pain is limited to basic questionnaires and physician interpretation, which yield subjective data. Genetic markers of pain sensitivity, such as single nucleotide polymorphisms in the catechol-O-methyltransferase gene, have been shown to be associated with pain perception and have been used to provide objective information about a patient's pain. The goal of this study was to determine if physician treatment adjustments based on genetic tests of pain perception resulted in improved outcomes for patients. A prospective, longitudinal study was conducted with 134 chronic non-cancer pain patients genotyped for pain perception-related catechol-O-methyltransferase haplotypes. Physicians were provided with patients' results and asked to document 1) their assessment of benefit of the genetic test; 2) treatment changes made based on the genetic test; and 3) patient clinical responses to changes implemented. Based on genetic testing results, physicians adjusted treatment plans for 40% of patients. When medication changes were made based on genetic testing results, 72% of patients showed improvement in clinical status. When non-pharmacological actions were performed, 69% of physicians felt their patients' clinical status improved. Moreover, physicians believed the genetic test results were consistent with patient pain levels in 85% of cases. These results demonstrate that providing personalized medicine with genetic information related to pain perception affected physician clinical decision-making for a substantial proportion of patients in this study, and that the availability and utilization of this information was a contributing factor in clinical improvement. Copyright © 2017 Elsevier Ltd. All rights reserved.

Prioritization in comparative effectiveness research: the CANCERGEN Experience.

PubMed

Thariani, Rahber; Wong, William; Carlson, Josh J; Garrison, Louis; Ramsey, Scott; Deverka, Patricia A; Esmail, Laura; Rangarao, Sneha; Hoban, Carolyn J; Baker, Laurence H; Veenstra, David L

2012-05-01

Systematic approaches to stakeholder-informed research prioritization are a central focus of comparative effectiveness research. Genomic testing in cancer is an ideal area to refine such approaches given rapid innovation and potentially significant impacts on patient outcomes. To develop and pilot test a stakeholder-informed approach to prioritizing genomic tests for future study in collaboration with the cancer clinical trials consortium SWOG. We conducted a landscape analysis to identify genomic tests in oncology using a systematic search of published and unpublished studies, and expert consultation. Clinically valid tests suitable for evaluation in a comparative study were presented to an external stakeholder group. Domains to guide the prioritization process were identified with stakeholder input, and stakeholders ranked tests using multiple voting rounds. A stakeholder group was created including representatives from patient-advocacy groups, payers, test developers, regulators, policy makers, and community-based oncologists. We identified 9 domains for research prioritization with stakeholder feedback: population impact; current standard of care, strength of association; potential clinical benefits, potential clinical harms, economic impacts, evidence of need, trial feasibility, and market factors. The landscape analysis identified 635 studies; of 9 tests deemed to have sufficient clinical validity, 6 were presented to stakeholders. Two tests in lung cancer (ERCC1 and EGFR) and 1 test in breast cancer (CEA/CA15-3/CA27.29) were identified as top research priorities. Use of a diverse stakeholder group to inform research prioritization is feasible in a pragmatic and timely manner. Additional research is needed to optimize search strategies, stakeholder group composition, and integration with existing prioritization mechanisms.

Prioritization in Comparative Effectiveness Research: The CANCERGEN Experience in Cancer Genomics

PubMed Central

Thariani, Rahber; Wong, William; Carlson, Josh J; Garrison, Louis; Ramsey, Scott; Deverka, Patricia A; Esmail, Laura; Rangarao, Sneha; Hoban, Carolyn J; Baker, Laurence H; Veenstra, David L

2012-01-01

Background Systematic approaches to stakeholder-informed research prioritization are a central focus of comparative effectiveness research. Genomic testing in cancer is an ideal area to refine such approaches given rapid innovation and potentially significant impacts on patient outcomes. Objective To develop and pilot-test a stakeholder-informed approach to prioritizing genomic tests for future study in collaboration with the cancer clinical trials consortium SWOG. Methods We conducted a landscape-analysis to identify genomic tests in oncology using a systematic search of published and unpublished studies, and expert consultation. Clinically valid tests suitable for evaluation in a comparative study were presented to an external stakeholder group. Domains to guide the prioritization process were identified with stakeholder input, and stakeholders ranked tests using multiple voting rounds. Results A stakeholder group was created including representatives from patient-advocacy groups, payers, test developers, regulators, policy-makers, and community-based oncologists. We identified nine domains for research prioritization with stakeholder feedback: population impact; current standard of care, strength of association; potential clinical benefits, potential clinical harms, economic impacts, evidence of need, trial feasibility, and market factors. The landscape-analysis identified 635 studies; of 9 tests deemed to have sufficient clinical validity, 6 were presented to stakeholders. Two tests in lung cancer (ERCC1 and EGFR) and one test in breast cancer (CEA/CA15-3/CA27.29) were identified as top research priorities. Conclusions Use of a diverse stakeholder group to inform research prioritization is feasible in a pragmatic and timely manner. Additional research is needed to optimize search strategies, stakeholder group composition and integration with existing prioritization mechanisms. PMID:22274803

[Effectiveness and difficulty of education on nosocomial infection control for pre-clinical practice in the clinic, so-called inclusive clinical practice phase I, for students in the Faculty of Dentistry, Tokyo Medical and Dental University].

PubMed

Sunakawa, Mitsuhiro; Matsumoto, Hiroyuki

2009-03-01

It has been planned to give pre-clinical practice in the clinic, so-called inclusive clinical practice phase I, for fifth-grade students in the School of Dentistry, Faculty of Dentistry, Tokyo Medical and Dental University, to give them the clinical training needed to perform dental practice and clinical practicum for comprehensive patient care, namely inclusive clinical practice phase II. This study analyzed the educative efficiency of the class on nosocomial infection control (NIC) by comparing achievements pre- and post-test, and discussed appropriate education planning on the NIC for dental students. Sixty-two fifth-grade students in the 2007 academic year sat the pre- and post-tests; the mean score and standard deviation of these tests were 5.30 +/- 1.26 (n = 56) and 8.59 +/- 1.18 (n = 59), respectively. There was a statistically significant difference between them (paired t-test, p < 0.01). Another finding was that students with high scores in the post-test did not necessarily achieve high ratings in the pre-test. It is suggested that the introduction of pre- and post-tests and the clarification of main points in the class as a theme of NIC could be a useful tool for increasing the comprehension of students on the theme. Since students at lower grades will attend clinical practice in the university hospital, it is thought that students should be given NIC training early in the clinical course, and the current curriculum should be improved to increase the opportunity for students to study this important issue.

Basophil-activation tests in Hymenoptera allergy.

PubMed

Dubois, Anthony E J; van der Heide, Sicco

2007-08-01

Despite recent advances in our understanding of basophil biology and discovery of new markers for basophil activation, tests measuring basophil activation are not widely utilized in Hymenoptera allergy. Studies of the basophil-activation test in Hymenoptera allergy were examined and the clinical utility of this test was assessed. It has been demonstrated that the results of basophil-activation tests correlate quite well with those of serum IgE testing or skin-prick tests. Many studies compare test outcomes with history in patients and nonallergic controls, so that specificity in sensitized but clinically nonreactive individuals remains unknown. Although one study showed that the basophil-activation test might predict immunotherapy side effects, this could not be confirmed in a second study, and no role has been established for the basophil-activation test in the monitoring of venom immunotherapy. The basophil-activation test has no extra value in assessing sting challenges, although experience is limited. The measurement of basophil-activation markers may be useful in detecting IgE-mediated sensitization but the relevance for application of the basophil-activation test in prediction of clinical reactivity in Hymenoptera allergy is very limited. For this reason, this test currently has no established role in the diagnosis and management of patients with insect sting allergy.

Genomic tests for ovarian cancer detection and management.

PubMed

Myers, Evan R; Havrilesky, Laura J; Kulasingam, Shalini L; Sanders, Gillian D; Cline, Kathryn E; Gray, Rebecca N; Berchuck, Andrew; McCrory, Douglas C

2006-10-01

To assess the evidence that the use of genomic tests for ovarian cancer screening, diagnosis, and treatment leads to improved outcomes. PubMed and reference lists of recent reviews. We evaluated tests for: (a) single gene products; (b) genetic variations affecting risk of ovarian cancer; (c) gene expression; and (d) proteomics. For tests covered in recent evidence reports (cancer antigen 125 [CA-125] and breast cancer genes 1 and 2 [BRCA1/2]), we added studies published subsequent to the reports. We sought evidence on: (a) the analytic performance of tests in clinical laboratories; (b) the sensitivity and specificity of tests in different patient populations; (c) the clinical impact of testing in asymptomatic women, women with suspected ovarian cancer, and women with diagnosed ovarian cancer; (d) the harms of genomic testing; and (e) the impact of direct-to-consumer and direct-to-physician advertising on appropriate use of tests. We also constructed a computer simulation model to test the impact of different assumptions about ovarian cancer natural history on the relative effectiveness of different strategies. There are reasonable data on the clinical laboratory performance of most radioimmunoassays, but the majority of the data on other genomic tests comes from research laboratories. Genomic test sensitivity/specificity estimates are limited by small sample sizes, spectrum bias, and unrealistically large prevalences of ovarian cancer; in particular, estimates of positive predictive values derived from most of the studies are substantially higher than would be expected in most screening or diagnostic settings. We found no evidence relevant to the question of the impact of genomic tests on health outcomes in asymptomatic women. Although there is a relatively large literature on the association of test results and various clinical outcomes, the clinical utility of changing management based on these results has not been evaluated. We found no evidence that genomic tests for ovarian cancer have unique harms beyond those common to other tests for genetic susceptibility or other tests used in screening, diagnosis, and management of ovarian cancer. Studies of a direct-to-consumer campaign for BRCA1/2 testing suggest increased utilization, but the effect on "appropriateness" was unclear. Model simulations suggest that annual screening, even with a highly sensitive test, will not reduce ovarian cancer mortality by more than 50 percent; frequent screening has a very low positive predictive value, even with a highly specific test. Although research remains promising, adaptation of genomic tests into clinical practice must await appropriately designed and powered studies in relevant clinical settings.

From Usability Testing to Clinical Simulations: Bringing Context into the Design and Evaluation of Usable and Safe Health Information Technologies. Contribution of the IMIA Human Factors Engineering for Healthcare Informatics Working Group.

PubMed

Kushniruk, A; Nohr, C; Jensen, S; Borycki, E M

2013-01-01

The objective of this paper is to explore human factors approaches to understanding the use of health information technology (HIT) by extending usability engineering approaches to include analysis of the impact of clinical context through use of clinical simulations. Methods discussed are considered on a continuum from traditional laboratory-based usability testing to clinical simulations. Clinical simulations can be conducted in a simulation laboratory and they can also be conducted in real-world settings. The clinical simulation approach attempts to bring the dimension of clinical context into stronger focus. This involves testing of systems with representative users doing representative tasks, in representative settings/environments. Application of methods where realistic clinical scenarios are used to drive the study of users interacting with systems under realistic conditions and settings can lead to identification of problems and issues with systems that may not be detected using traditional usability engineering methods. In conducting such studies, careful consideration is needed in creating ecologically valid test scenarios. The evidence obtained from such evaluation can be used to improve both the usability and safety of HIT. In addition, recent work has shown that clinical simulations, in particular those conducted in-situ, can lead to considerable benefits when compared to the costs of running such studies. In order to bring context of use into the testing of HIT, clinical simulation, involving observing representative users carrying out tasks in representative settings, holds considerable promise.

Rapid Automated Antimicrobial Susceptibility Testing of Streptococcus pneumoniae by Use of the bioMerieux VITEK 2

PubMed Central

Jorgensen, James H.; Barry, Arthur L.; Traczewski, M. M.; Sahm, Daniel F.; McElmeel, M. Leticia; Crawford, Sharon A.

2000-01-01

The VITEK 2 is a new automated instrument for rapid organism identification and susceptibility testing. It has the capability of performing rapid susceptibility testing of Streptococcus pneumoniae with specially configured cards that contain enriched growth medium and antimicrobial agents relevant for this organism. The present study compared the results of testing of a group of 53 challenge strains of pneumococci with known resistance properties and a collection of clinical isolates examined in two study phases with a total of 402 and 416 isolates, respectively, with a prototype of the VITEK 2. Testing was conducted in three geographically separate laboratories; the challenge collection was tested by all three laboratories, and the unique clinical isolates were tested separately by the individual laboratories. The VITEK 2 results of tests with 10 antimicrobial agents were compared to the results generated by the National Committee for Clinical Laboratory Standards reference broth microdilution MIC test method. Excellent interlaboratory agreement was observed with the challenge strains. The overall agreement within a single twofold dilution of MICs defined by the VITEK 2 and reference method with the clinical isolates was 96.3%, although there were a number of off-scale MICs that could not be compared. The best agreement with the clinical isolates was achieved with ofloxacin and chloramphenicol (100%), and the lowest level of agreement among those drugs with sufficient on-scale MICs occurred with trimethoprim-sulfamethoxazole (89.7%). Overall there were 1.3% very major, 6.6% minor, and no major interpretive category errors encountered with the clinical isolates, although >80% of the minor interpretive errors involved only a single log2 dilution difference. The mean time for generation of susceptibility results with the clinical isolates was 8.1 h. The VITEK 2 provided rapid, reliable susceptibility category determinations with both the challenge and clinical isolates examined in this study. PMID:10921932

The impact of lay counselors on HIV testing rates: Quasi-experimental evidence from lay counselor redeployment in KwaZulu-Natal, South Africa.

PubMed

Hu, Janice; Geldsetzer, Pascal; Steele, Sarah Jane; Matthews, Philippa; Ortblad, Katrina; Solomon, Tsion; Shroufi, Amir; van Cutsem, Gilles; Tanser, Frank; Wyke, Sally; Vollmer, Sebastian; Pillay, Deenan; Mcconnell, Margaret; Bärnighausen, Till

2018-06-14

This study aimed to determine the causal effect of the number of lay counselors employed at a primary care clinic in rural South Africa on the number of clinic-based HIV tests performed. Fixed effects panel analysis. We collected monthly data on the number of lay counselors employed and HIV tests performed at nine primary care clinics in rural KwaZulu-Natal from January 2014 to December 2015. Using clinic- and month-level fixed effects regressions, we exploited the fact that lay counselors were removed from clinics at two quasi-random time points by a redeployment policy. A total of 24,526 HIV tests were conducted over the study period. 21 of 27 lay counselors were removed across the nine clinics in the two redeployment waves. A ten percent reduction in the number of lay counselors was associated with a 4.9% (95% confidence interval [CI]: 2.8 - 7.0, p < 0.001) decrease in the number of HIV tests performed. In absolute terms, losing one lay counselor from a clinic was associated with a mean of 29.7 (95% CI: 21.2 - 38.2, p < 0.001) fewer HIV tests carried out at the clinic per month. This study provides evidence for the crucial role that lay counselors play in the HIV response in rural South Africa. More broadly, this analysis supports the use of lay cadres in the HIV response and by extension UNAIDS' and the African Union's goal to triple the number of community health workers in sub-Saharan Africa by 2020.

Concurrent validity and clinical usefulness of several individually administered tests of children's social-emotional cognition.

PubMed

McKown, Clark

2007-03-01

In this study, the validity of 5 tests of children's social-emotional cognition, defined as their encoding, memory, and interpretation of social information, was tested. Participants were 126 clinic-referred children between the ages of 5 and 17. All 5 tests were evaluated in terms of their (a) concurrent validity, (b) incremental validity, and (c) clinical usefulness in predicting social functioning. Tests included measures of nonverbal sensitivity, social language, and social problem solving. Criterion measures included parent and teacher report of social functioning. Analyses support the concurrent validity of all measures, and the incremental validity and clinical usefulness of tests of pragmatic language and problem solving.

Current Experience in Testing Mitochondrial Nutrients in Disorders Featuring Oxidative Stress and Mitochondrial Dysfunction: Rational Design of Chemoprevention Trials

PubMed Central

Pagano, Giovanni; Aiello Talamanca, Annarita; Castello, Giuseppe; Cordero, Mario D.; d’Ischia, Marco; Gadaleta, Maria Nicola; Pallardó, Federico V.; Petrović, Sandra; Tiano, Luca; Zatterale, Adriana

2014-01-01

An extensive number of pathologies are associated with mitochondrial dysfunction (MDF) and oxidative stress (OS). Thus, mitochondrial cofactors termed “mitochondrial nutrients” (MN), such as α-lipoic acid (ALA), Coenzyme Q10 (CoQ10), and l-carnitine (CARN) (or its derivatives) have been tested in a number of clinical trials, and this review is focused on the use of MN-based clinical trials. The papers reporting on MN-based clinical trials were retrieved in MedLine up to July 2014, and evaluated for the following endpoints: (a) treated diseases; (b) dosages, number of enrolled patients and duration of treatment; (c) trial success for each MN or MN combinations as reported by authors. The reports satisfying the above endpoints included total numbers of trials and frequencies of randomized, controlled studies, i.e., 81 trials testing ALA, 107 reports testing CoQ10, and 74 reports testing CARN, while only 7 reports were retrieved testing double MN associations, while no report was found testing a triple MN combination. A total of 28 reports tested MN associations with “classical” antioxidants, such as antioxidant nutrients or drugs. Combinations of MN showed better outcomes than individual MN, suggesting forthcoming clinical studies. The criteria in study design and monitoring MN-based clinical trials are discussed. PMID:25380523

Factors associated with Chlamydia trachomatis testing in a high school based screening and previously in clinical practice: a cross-sectional study in Norway

PubMed Central

2013-01-01

Background High school based chlamydia screening has been shown to increase uptake and detect hidden infections among sexually active adolescents. Our study aimed to: i) examine the proportions of 15–20 year-olds tested in a high school based screening and previously in clinical practice, ii) determine chlamydia prevalence according to testing pattern, and iii) examine factors associated with testing in the two settings. Methods A population based cross-sectional study was conducted in 5 high schools in Norway in 2009, using web-questionnaires and Chlamydia trachomatis PCR in first-void urine (800 girls/818 boys, mean age 17.2 years). Only sexually active participants at risk for chlamydia infections were included in the analyses. Crude and multivariable logistic regression models were applied with ‘clinic based testing’ and ‘school based screening’ as outcome variables. Results 56% of girls and 21% of boys reported previous clinic based testing. In the school based screening, 93% were tested with no gender difference. 42% of girls and 74% of boys were tested for the first time at school (‘school-only test’). Both girls with clinic based testing and girls with school-only test had high chlamydia prevalence (7.3% vs 7.2%). Boys with clinic based testing had twice the prevalence of those with school-only test (6.2% vs 3.0%, p = 0.01). Half of infections were detected in participants with school-only test. One-fifth were repeat infections. In multivariable analysis of girls and boys combined, female gender, older age, early sexual debut, no condom use at first and last intercourse, steady relationship, and higher number of lifetime partners increased the odds of clinic based testing. The odds of school based screening increased with male gender, academic affiliation, later sexual debut, condom use at first intercourse, and current urogenital symptoms in multivariable analysis. Conclusions More than half the girls had been tested prior to the school based screening and had high prevalence independent of previous clinic based testing. School screening was mostly associated with factors unknown to increase chlamydia infection risk, while clinic based testing was associated with traditional risk factors. The unusually high and equal participation between genders and the detection of a large chlamydia reservoir confirms the value of school based screening suggesting this approach to be further explored in Norway. PMID:23915415

Sole Dependence on Urine Testing Strips and the Ability to Identify Clinically Significant Disease: Challenging the Current Paradigm for Heme Detection in General Clinical Situations.

PubMed

Rothschild, Bruce

2016-05-01

The ability of health care professionals to provide patient care is potentially compromised when predicated on untested, although longstanding, perspectives. One such example is urinalysis testing, which has been currently simplified to use only urine testing strips for detection of microscopic hematuria. To determine whether urine testing strips are sufficient for identification of clinically significant findings in urinalysis. To determine the presence of microscopic hematuria, I examined a collection of urine specimens that had tested heme negative during the 3-month study period. Of the 342 patients from whom urine specimens were examined during this interval, 50 had microscopic hematuria, despite having tested negative for heme via urine testing strip. Also, 30% were not receiving any medication known to produce microscopic hematuria, and 18% had clinically significant pathology. Diagnosis of significant clinical pathologic manifestations would have been compromised had microscopic examination not been performed on the urine specimens from the cohort individuals. Examination of the novel approach of including microscopic examination of specimens in a specific clinical situation challenges the dominant paradigm of reliance on assaying using urine testing strips only, revealing that the current method is not only unreliable for determining microscopic hematuria but also is less than optimal in general clinical practice. The findings of this study provide evidence of the importance of microscopic evaluation as a routine component of urinalysis. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The Abbott RealTime High Risk HPV test is a clinically validated human papillomavirus assay for triage in the referral population and use in primary cervical cancer screening in women 30 years and older: a review of validation studies.

PubMed

Poljak, Mario; Oštrbenk, Anja

2013-01-01

Human papillomavirus (HPV) testing has become an essential part of current clinical practice in the management of cervical cancer and precancerous lesions. We reviewed the most important validation studies of a next-generation real-time polymerase chain reaction-based assay, the RealTime High Risk HPV test (RealTime)(Abbott Molecular, Des Plaines, IL, USA), for triage in referral population settings and for use in primary cervical cancer screening in women 30 years and older published in peer-reviewed journals from 2009 to 2013. RealTime is designed to detect 14 high-risk HPV genotypes with concurrent distinction of HPV-16 and HPV-18 from 12 other HPV genotypes. The test was launched on the European market in January 2009 and is currently used in many laboratories worldwide for routine detection of HPV. We concisely reviewed validation studies of a next-generation real-time polymerase chain reaction (PCR)-based assay: the Abbott RealTime High Risk HPV test. Eight validation studies of RealTime in referral settings showed its consistently high absolute clinical sensitivity for both CIN2+ (range 88.3-100%) and CIN3+ (range 93.0-100%), as well as comparative clinical sensitivity relative to the currently most widely used HPV test: the Qiagen/Digene Hybrid Capture 2 HPV DNA Test (HC2). Due to the significantly different composition of the referral populations, RealTime absolute clinical specificity for CIN2+ and CIN3+ varied greatly across studies, but was comparable relative to HC2. Four validation studies of RealTime performance in cervical cancer screening settings showed its consistently high absolute clinical sensitivity for both CIN2+ and CIN3+, as well as comparative clinical sensitivity and specificity relative to HC2 and GP5+/6+ PCR. RealTime has been extensively evaluated in the last 4 years. RealTime can be considered clinically validated for triage in referral population settings and for use in primary cervical cancer screening in women 30 years and older.

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 Performance of a Molecular Test versus Clinician Assessment of Vaginitis

PubMed Central

Gaydos, Charlotte A.; Nyirjesy, Paul; Paradis, Sonia; Kodsi, Salma; Cooper, Charles K.

2018-01-01

ABSTRACT Vaginitis is a common complaint, diagnosed either empirically or using Amsel's criteria and wet mount microscopy. This study sought to determine characteristics of an investigational test (a molecular test for vaginitis), compared to reference, for detection of bacterial vaginosis, Candida spp., and Trichomonas vaginalis. Vaginal specimens from a cross-sectional study were obtained from 1,740 women (≥18 years old), with vaginitis symptoms, during routine clinic visits (across 10 sites in the United States). Specimens were analyzed using a commercial PCR/fluorogenic probe-based investigational test that detects bacterial vaginosis, Candida spp., and Trichomonas vaginalis. Clinician diagnosis and in-clinic testing (Amsel's test, potassium hydroxide preparation, and wet mount) were also employed to detect the three vaginitis causes. All testing methods were compared to the respective reference methods (Nugent Gram stain for bacterial vaginosis, detection of the Candida gene its2, and Trichomonas vaginalis culture). The investigational test, clinician diagnosis, and in-clinic testing were compared to reference methods for bacterial vaginosis, Candida spp., and Trichomonas vaginalis. The investigational test resulted in significantly higher sensitivity and negative predictive value than clinician diagnosis or in-clinic testing. In addition, the investigational test showed a statistically higher overall percent agreement with each of the three reference methods than did clinician diagnosis or in-clinic testing. The investigational test showed significantly higher sensitivity for detecting vaginitis, involving more than one cause, than did clinician diagnosis. Taken together, these results suggest that a molecular investigational test can facilitate accurate detection of vaginitis. PMID:29643195

Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

PubMed

Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso

2004-03-01

The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.

78 FR 65338 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

..., other clinical studies, or in vitro testing. Reports from animal testing are not included. \\3\\ Includes... serious risks from clinical trials within 15 calendar days for findings from in vitro testing that suggest...

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

Effectiveness of a computer-aided neuroanatomy program for entry-level physical therapy students: anatomy and clinical examination of the dorsal column-medial lemniscal system.

PubMed

McKeough, D Michael; Mattern-Baxter, Katrin; Barakatt, Edward

2010-01-01

The purpose of this study was to determine if a computer-aided instruction learning module improves students' knowledge of the neuroanatomy/physiology and clinical examination of the dorsal column-medial lemniscal (DCML) system. Sixty-one physical therapy students enrolled in a clinical neurology course in entry-level PT educational programs at two universities participated in the study. Students from University-1 (U1;) had not had a previous neuroanatomy course, while students from University-2 (U2;) had taken a neuroanatomy course in the previous semester. Before and after working with the learning module, students took a paper-and-pencil test on the neuroanatomy/physiology and clinical examination of the DCML system. Kruskal-Wallis one-way ANOVA and Mann-Whitney tests were used to determine if differences existed between neuroanatomy/physiology examination scores and clinical examination scores before and after taking the learning module, and between student groups based on university attended. For students from U1, neuroanatomy/physiology post-test scores improved significantly over pre-test scores (p < 0.001), while post-test scores of students from U2 did not (p = 0.60). Neuroanatomy/physiology pre-test scores from U2 were significantly better than those from U1 (p < 0.001); there was no significant difference in post-test scores (p = 0.062). Clinical examination pre-test and post-test scores from U2 were significantly better than those from U1 (p < 0.001). Clinical examination post-test scores improved significantly from the pre-test scores for both U1 (p < 0.001) and U2 (p < 0.001).

Making sense of a new technology in clinical practice: a qualitative study of patient and physician perspectives.

PubMed

Pals, Regitze A S; Hansen, Ulla M; Johansen, Clea B; Hansen, Christian S; Jørgensen, Marit E; Fleischer, Jesper; Willaing, Ingrid

2015-09-22

The number of new technologies for risk assessment available in health care is increasing. These technologies are intended to contribute to both improved care practices and improved patient outcomes. To do so however, there is a need to study how new technologies are understood and interpreted by users in clinical practice. The objective of this study was to explore patient and physician perspectives on the usefulness of a new technology to detect Cardiovascular Autonomic Neuropathy (CAN) in a specialist diabetes clinic. The technology is a handheld device that measures resting heart rate and conducts three cardiac autonomic reflex tests to evaluate heart rate variability. The study relied on three sources of data: observations of medical consultations where results of the CAN test were reported (n = 8); interviews with patients who had received the CAN test (n = 19); and interviews with physicians who reported results of the CAN test (n = 9). Data were collected at the specialist diabetes clinic between November 2013 and January 2014. Data were analysed using the concept of technological frames which is used to assess how physicians and patients understand and interpret the new technology. Physicians generally found it difficult to communicate test results to patients in terms that patients could understand and to translate results into meaningful implications for the treatment of patients. Results of the study indicate that patients did not recall having done the CAN test nor recall receiving the results. Furthermore, patients were generally unsure about the purpose of the CAN test and the implications of the results. Involving patients and physicians is essential when a new technology is introduced in clinical practice. This particularly includes the interpretation and communication processes related to its use. The integration of a new risk assessment technology into clinical practice can be accompanied by several challenges. It is suggested that more information about the CAN test be provided to patients and that a dialogue-based approach be used when communicating test results to patients in order to best support the use of the technology in clinical practice.

Nursing students' viewpoints toward two methods of clinical conference and clinical nursing round.

PubMed

Gheidanzadeh, Maryam; Baghersad, Zahra; Abazari, Parvaneh

2017-01-01

Clinical education provides a chance to combine theoretical knowledge and clinical skills. Students are the key elements in the evaluation of clinical education efficacy. The present study was aimed to define nursing students' viewpoints concerning conformity to the characteristics of clinical conference and clinical round. This descriptive analytical study was conducted on the bachelor's students of the 4 th -6 th semester of nursing. Sampling was conducted using census sampling method during the 2 nd semester of 2014-2015 school year. Data collection tool was a three-section researcher-made questionnaire containing demographic, nursing round, and clinical conference characteristics. Descriptive and inferential statistical tests (independent t -test, ANOVA, and Spearman and Pearson correlation coefficients) were used for data analysis. Participants were 134 bachelor's students of the 4 th -6 th semester of nursing. According to half of the participants, conformity to the characteristics of clinical conference (45.5%, 53%) and clinical round (44%, 51.5%) were poor and medium, respectively. Paired t -test showed a significant difference between students' viewpoints toward the planning of clinical conference and clinical nursing round ( P = 0.006, t = 2.77). According to the results of the present study on students' viewpoints, clinical education faces a serious challenge with regard to clinical education methods. Considering the necessity and importance of clinical education, more investigation should be conducted to detect its relevant factors and plan for its improvement.

What is the value of routinely testing full blood count, electrolytes and urea, and pulmonary function tests before elective surgery in patients with no apparent clinical indication and in subgroups of patients with common comorbidities: a systematic review of the clinical and cost-effective literature.

PubMed

Czoski-Murray, C; Lloyd Jones, M; McCabe, C; Claxton, K; Oluboyede, Y; Roberts, J; Nicholl, J P; Rees, A; Reilly, C S; Young, D; Fleming, T

2012-12-01

The evidence base which supported the National Institute for Health and Clinical Excellence (NICE) published Clinical Guideline 3 was limited and 50% was graded as amber. However, the use of tests as part of pre-operative work-up remains a low-cost but high-volume activity within the NHS, with substantial resource implications. The objective of this study was to identify, evaluate and synthesise the published evidence on the clinical effectiveness and cost-effectiveness of the routine use of three tests, full blood counts (FBCs), urea and electrolytes tests (U&Es) and pulmonary function tests, in the pre-operative work-up of otherwise healthy patients undergoing minor or intermediate surgery in the NHS. The aims of this study were to estimate the clinical effectiveness and cost-effectiveness of routine pre-operative testing of FBC, electrolytes and renal function and pulmonary function in adult patients classified as American Society of Anaesthesiologists (ASA) grades 1 and 2 undergoing elective minor (grade 1) or intermediate (grade 2) surgical procedures; to compare NICE recommendations with current practice; to evaluate the cost-effectiveness of mandating or withdrawing each of these tests in this patient group; and to identify the expected value of information and whether or not it has value to the NHS in commissioning further primary research into the use of these tests in this group of patients. The following electronic bibliographic databases were searched: (1) BIOSIS; (2) Cumulative Index to Nursing and Allied Health Literature; (3) Cochrane Database of Systematic Reviews; (4) Cochrane Central Register of Controlled Trials; (5) EMBASE; (6) MEDLINE; (7) MEDLINE In-Process & Other Non-Indexed Citations; (8) NHS Database of Abstracts of Reviews of Effects; (9) NBS Health Technology Assessment Database; and (10) Science Citation Index. To identify grey and unpublished literature, the Cochrane Register of Controlled Trials, National Research Register Archive, National Institute for Health Research Clinical Research Network Portfolio database and the Copernic Meta-search Engine were searched. A large routine data set which recorded the results of tests was obtained from Leeds Teaching Hospitals Trust. A systematic review of the literature was carried out. The searches were undertaken in March to April 2008 and June 2009. Searches were designed to retrieve studies that evaluated the clinical effectiveness and cost-effectiveness of routine pre-operative testing of FBC, electrolytes and renal function and pulmonary function in the above group of patients. A postal survey of current practice in testing patients in this group pre-operatively was undertaken in 2008. An exemplar cost-effectiveness model was constructed to demonstrate what form this would have taken had there been sufficient data. A large routine data set that recorded the results of tests was obtained from Leeds Teaching Hospitals Trust. This was linked to individual patient data with surgical outcomes, and regression models were estimated. A comprehensive and systematic search of both the clinical effectiveness and cost-effectiveness literature identified a large number of potentially relevant studies. However, when these studies were subjected to detailed review and quality assessment, it became clear that the literature provides no evidence on the clinical effectiveness and cost-effectiveness of these specific tests in the specific patient groups. The postal survey had a 17% response rate. Results reported that in ASA grade 1, patients aged < 40 years with no comorbidities undergoing minor surgery did not have routine tests for FBC, electrolytes and renal function and pulmonary function. The results from the regression model showed that the frequency of test use was not consistent with the hypothesis of their routine use. FBC tests were performed in only 58% of patients in the data set and U&E testing was carried out in only 57%. Systematic searches of the clinical effectiveness and cost-effectiveness literature found that there is no evidence on the clinical effectiveness or cost-effectiveness of these tests in this specific clinical context for the NHS. A survey of NHS hospitals found that respondent trusts were implementing current NICE guidance in relation to pre-operative testing generally, and a de novo analysis of routine data on test utilisation and post-operative outcome found that the tests were not be used in routine practice; rather, use was related to an expectation of a more complex clinical case. The paucity of published evidence is a limitation of this study. The studies included relied on non-UK health-care systems data, which may not be transferable. The inclusion of non-randomised studies is associated with an increased risk of bias and confounding. Scoping work to establish the likely mechanism of action by which tests would impact upon outcomes and resource utilisation established that the cause of an abnormal test result is likely to be a pivotal determinant of the cost-effectiveness of a pre-operative test and therefore evaluations would need to consider tests in the context of the underlying risk of specific clinical problems (i.e. risk guided rather than routine use). The time of universal utilisation of pre-operative tests for all surgical patients is likely to have passed. The evidence we have identified, though weak, indicates that tests are increasingly utilised in patients in whom there is a reason to consider an underlying raised risk of a clinical abnormality that should be taken into account in their clinical management. It is likely that this strategy has led to substantial resource savings for the NHS, although there is not a published evidence base to establish that this is the case. The total expenditure on pre-operative tests across the NHS remains significant. Evidence on current practice indicates that clinical practice has changed to such a degree that the original research question is no longer relevant to UK practice. Future research on the value of these tests in pre-operative work-up should be couched in terms of the clinical effectiveness and cost-effectiveness in the identification of specific clinical abnormalities in patients with a known underlying risk. We suggest that undertaking a multicentre study making use of linked, routinely collected data sets would identify the extent and nature of pre-operative testing in this group of patients. The National Institute for Health Research Health Technology Assessment programme.

The clinical effectiveness and cost-effectiveness of the PROGENSA® prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation.

PubMed

Nicholson, Amanda; Mahon, James; Boland, Angela; Beale, Sophie; Dwan, Kerry; Fleeman, Nigel; Hockenhull, Juliet; Dundar, Yenal

2015-10-01

There is no single definitive test to identify prostate cancer in men. Biopsies are commonly used to obtain samples of prostate tissue for histopathological examination. However, this approach frequently misses cases of cancer, meaning that repeat biopsies may be necessary to obtain a diagnosis. The PROGENSA(®) prostate cancer antigen 3 (PCA3) assay (Hologic Gen-Probe, Marlborough, MA, USA) and the Prostate Health Index (phi; Beckman Coulter Inc., Brea, CA, USA) are two new tests (a urine test and a blood test, respectively) that are designed to be used to help clinicians decide whether or not to recommend a repeat biopsy. To evaluate the clinical effectiveness and cost-effectiveness of the PCA3 assay and the phi in the diagnosis of prostate cancer. Multiple publication databases and trial registers were searched in May 2014 (from 2000 to May 2014), including MEDLINE, EMBASE, The Cochrane Library, ISI Web of Science, Medion, Aggressive Research Intelligence Facility database, ClinicalTrials.gov, International Standard Randomised Controlled Trial Number Register and World Health Organization International Clinical Trials Registry Platform. The assessment of clinical effectiveness involved three separate systematic reviews, namely reviews of the analytical validity, the clinical validity of these tests and the clinical utility of these tests. The assessment of cost-effectiveness comprised a systematic review of full economic evaluations and the development of a de novo economic model. The perspective of the evaluation was the NHS in England and Wales. Men suspected of having prostate cancer for whom the results of an initial prostate biopsy were negative or equivocal. The use of the PCA3 score or phi in combination with existing tests (including histopathology results, prostate-specific antigen level and digital rectal examination), multiparametric magnetic resonance imaging and clinical judgement. In addition to documents published by the manufacturers, six studies were identified for inclusion in the analytical validity review. The review identified issues concerning the precision of the PCA3 assay measurements. It also highlighted issues relating to the storage requirements and stability of samples intended for analysis using the phi assay. Fifteen studies met the inclusion criteria for the clinical validity review. These studies reported results for 10 different clinical comparisons. There was insufficient evidence to enable the identification of appropriate test threshold values for use in a clinical setting. In addition, the implications of adding either the PCA3 assay or the phi to clinical assessment were not clear. Furthermore, the addition of the PCA3 assay or the phi to clinical assessment plus magnetic resonance imaging was not found to improve discrimination. No published papers met the inclusion criteria for either the clinical utility review or the cost-effectiveness review. The results from the cost-effectiveness analyses indicated that using either the PCA3 assay or the phi in the NHS was not cost-effective. The main limitations of the systematic review of clinical validity are that the review conclusions are over-reliant on findings from one study, the descriptions of clinical assessment vary widely within reviewed studies and many of the reported results for the clinical validity outcomes do not include either standard errors or confidence intervals. The clinical benefit of using the PCA3 assay or the phi in combination with existing tests, scans and clinical judgement has not yet been confirmed. The results from the cost-effectiveness analyses indicate that the use of these tests in the NHS would not be cost-effective. This study is registered as PROSPERO CRD42014009595. The National Institute for Health Research Health Technology Assessment programme.

Prospective Clinical Evaluation of the Serologic Tuberculous Glycolipid Test in Combination with the Nucleic Acid Amplification Test

PubMed Central

Maekura, Ryoji; Kohno, Hiroaki; Hirotani, Atsushi; Okuda, Yoshinari; Ito, Masami; Ogura, Takeshi; Yano, Ikuya

2003-01-01

We have conducted a prospective controlled multicenter study to evaluate differences in the levels of clinical utility of the tuberculous glycolipid (TBGL) serodiagnostic test and the nucleic acid amplification test in patients with smear-negative active pulmonary tuberculosis (TB). The TBGL test and the PCR test were individually not so useful for the rapid diagnosis of smear-negative active pulmonary TB. However, clinical utility was considerably improved by using the TBGL test and the PCR test in combination, especially in patients with smear-negative and culture-negative active pulmonary TB and in patients with minimally advanced lesions. PMID:12624077

Non-invasive prenatal testing (NIPT): Europe's first multicenter post-market clinical follow-up study validating the quality in clinical routine.

PubMed

Flöck, Anne; Tu, Ngoc-Chi; Rüland, Anna; Holzgreve, Wolfgang; Gembruch, Ulrich; Geipel, Annegret

2017-11-01

Non-invasive prenatal tests (NIPT) for the determination of fetal aneuploidies from maternal blood are firmly established in clinical routine. For the first time, the accuracy of an NIPT for the determination of trisomies 21, 18 and 13 in singleton pregnancies was assessed by means of a prospective German-wide multicenter post-market clinical follow-up study, to reliably evaluate the quality in clinical routine. The study covered the indications for testing, the test results, the rate of invasive diagnostics and the pregnancy outcome. 2232 cases were tested for trisomy 21. Of these, 1946 cases were additionally examined for trisomy 18 and 13. Sensitivity and specificity for trisomy 21 (43/43) and for trisomy 13 (2/2) were 100%, for trisomy 18 the sensitivity was 80% (4/5) with a specificity of 99.8%. Three false-positive results for trisomy 18 were observed (FPR 0.15%). The no-call rate was 0.5%. In this subgroup, 27.3% (3/11) aneuploidies were diagnosed. The rate of invasive procedures was 2.6%. NIPT provides a very high quality for the fetal trisomies 21, 13 and 18 in clinical routine. The results support the recommendation that NIPT should be offered after genetic counseling and only in conjunction with a qualified ultrasound examination.

Profiles of Urine Drug Test in Clinical Pain Patients vs Pain Research Study Subjects.

PubMed

Lee, Cheng-ting; Vo, Trang T; Cohen, Abigail S; Ahmed, Shihab; Zhang, Yi; Mao, Jianren; Chen, Lucy

2016-04-01

To examine similarities and differences in urine drug test (UDT) results in clinical pain patients and pain subjects participating in pain research studies. An observational study with retrospective chart review and data analysis. We analyzed 1,874 UDT results obtained from 1) clinical pain patients (Clinical Group; n = 1,529) and 2) pain subjects consented to participate in pain research studies (Research Group; n = 345). Since several medications such as opioids used in pain management are drugs of abuse (DOA) and can result in a positive UDT, we specifically identified those cases of positive UDT due to nonprescribed DOA and designated these cases as positive UDT with DOA (PUD). We found that 1) there was a higher rate of PUD in clinical pain patients (41.3%) than in pain research study subjects (14.8%); 2) although subjects in the Research Group were informed ahead of time that UDT will be conducted as a screening test, a substantial number (14.8%) of pain research study subjects still showed PUD; 3) there were different types of DOA between clinical pain patients (cannabinoids as the top DOA) and research study subjects (cocaine as the top DOA); and 4) a common factor associated with PUD was opioid therapy in both Clinical Group and Research Group. These results support previous findings that PUD is a common finding in clinical pain patients, particularly in those prescribed opioid therapy, and we suggest that UDT be used as routine screening testing in pain research studies. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Assessment of statistical significance and clinical relevance.

PubMed

Kieser, Meinhard; Friede, Tim; Gondan, Matthias

2013-05-10

In drug development, it is well accepted that a successful study will demonstrate not only a statistically significant result but also a clinically relevant effect size. Whereas standard hypothesis tests are used to demonstrate the former, it is less clear how the latter should be established. In the first part of this paper, we consider the responder analysis approach and study the performance of locally optimal rank tests when the outcome distribution is a mixture of responder and non-responder distributions. We find that these tests are quite sensitive to their planning assumptions and have therefore not really any advantage over standard tests such as the t-test and the Wilcoxon-Mann-Whitney test, which perform overall well and can be recommended for applications. In the second part, we present a new approach to the assessment of clinical relevance based on the so-called relative effect (or probabilistic index) and derive appropriate sample size formulae for the design of studies aiming at demonstrating both a statistically significant and clinically relevant effect. Referring to recent studies in multiple sclerosis, we discuss potential issues in the application of this approach. Copyright © 2012 John Wiley & Sons, Ltd.

The impact of rheologically controlled materials on the identification of airway compromise on the clinical and videofluoroscopic swallowing examinations.

PubMed

Groher, Michael E; Crary, Michael A; Carnaby Mann, Giselle; Vickers, Zata; Aguilar, Carlos

2006-10-01

Numerous studies have suggested that the clinical evaluation of swallowing fails to adequately identify those patients who aspirate or do not aspirate on a videofluoroscopic swallowing examination. These conclusions, however, are based on comparisons between swallowed materials that were not rheologically matched. The present study used a battery of rheologically matched test materials, involving thin and thick liquids and cohesive and adhesive semisolids. Using these test items, results from a clinical swallow evaluation were compared to the results of a videofluorographic evaluation using identical test materials. Results suggest that the use of three test materials, including thin and thick liquids given in volumes of 5 and 10 ml, demonstrated the strongest associations between cough on the clinical examination and aspiration on the videofluoroscopic examination.

Clinical Trials

MedlinePlus

Clinical trials are research studies that test how well new medical approaches work in people. Each study ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to ...

Current nonclinical testing paradigm enables safe entry to First-In-Human clinical trials: The IQ consortium nonclinical to clinical translational database.

PubMed

Monticello, Thomas M; Jones, Thomas W; Dambach, Donna M; Potter, David M; Bolt, Michael W; Liu, Maggie; Keller, Douglas A; Hart, Timothy K; Kadambi, Vivek J

2017-11-01

The contribution of animal testing in drug development has been widely debated and challenged. An industry-wide nonclinical to clinical translational database was created to determine how safety assessments in animal models translate to First-In-Human clinical risk. The blinded database was composed of 182 molecules and contained animal toxicology data coupled with clinical observations from phase I human studies. Animal and clinical data were categorized by organ system and correlations determined. The 2×2 contingency table (true positive, false positive, true negative, false negative) was used for statistical analysis. Sensitivity was 48% with a 43% positive predictive value (PPV). The nonhuman primate had the strongest performance in predicting adverse effects, especially for gastrointestinal and nervous system categories. When the same target organ was identified in both the rodent and nonrodent, the PPV increased. Specificity was 84% with an 86% negative predictive value (NPV). The beagle dog had the strongest performance in predicting an absence of clinical adverse effects. If no target organ toxicity was observed in either test species, the NPV increased. While nonclinical studies can demonstrate great value in the PPV for certain species and organ categories, the NPV was the stronger predictive performance measure across test species and target organs indicating that an absence of toxicity in animal studies strongly predicts a similar outcome in the clinic. These results support the current regulatory paradigm of animal testing in supporting safe entry to clinical trials and provide context for emerging alternate models. Copyright © 2017 Elsevier Inc. All rights reserved.

The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field.

PubMed

Wolpaw, Benjamin J; Mathews, Catherine; Chopra, Mickey; Hardie, Diana; de Azevedo, Virginia; Jennings, Karen; Lurie, Mark N

2010-03-22

The rapid HIV antibody test is the diagnostic tool of choice in low and middle-income countries. Previous evidence suggests that rapid HIV diagnostic tests may underperform in the field, failing to detect a substantial number of infections. A research study inadvertently discovered that a clinic rapid HIV testing process was failing to detect cases of established (high antibody titer) infection, exhibiting an estimated 68.7% sensitivity (95% CI [41.3%-89.0%]) over the course of the first three weeks of observation. The setting is a public service clinic that provides STI diagnosis and treatment in an impoverished, peri-urban community outside of Cape Town, South Africa. The researchers and local health administrators collaborated to investigate the cause of the poor test performance and make necessary corrections. The clinic changed the brand of rapid test being used and later introduced quality improvement measures. Observations were made of the clinic staff as they administered rapid HIV tests to real patients. Estimated testing sensitivity was calculated as the number of rapid HIV test positive individuals detected by the clinic divided by this number plus the number of PCR positive, highly reactive 3rd generation ELISA patients identified among those who were rapid test negative at the clinic. In the period of five months after the clinic made the switch of rapid HIV tests, estimated sensitivity improved to 93.5% (95% CI [86.5%-97.6%]), during which time observations of counselors administering tests at the clinic found poor adherence to the recommended testing protocol. Quality improvement measures were implemented and estimated sensitivity rose to 95.1% (95% CI [83.5%-99.4%]) during the final two months of full observation. Poor testing procedure in the field can lead to exceedingly low levels of rapid HIV test sensitivity, making it imperative that stringent quality control measures are implemented where they do not already exist. Certain brands of rapid-testing kits may perform better than others when faced with sub-optimal use.

Repeat Chlamydia trachomatis testing among heterosexual STI outpatient clinic visitors in the Netherlands: a longitudinal study.

PubMed

Visser, Maartje; van Aar, Fleur; Koedijk, Femke D H; Kampman, Carolina J G; Heijne, Janneke C M

2017-12-20

Chlamydia infections are common in both men and women, are often asymptomatic and can cause serious complications. Repeat testing in high-risk groups is therefore indicated. In the Netherlands, guidelines on repeat chlamydia testing differ between testing facilities, and knowledge on repeat testing behaviour is limited. Here, we analyse the current repeat testing behaviour of heterosexual STI clinic visitors, and aim to identify groups for which repeat testing advice could be advantageous. Longitudinal surveillance data from all Dutch STI outpatient clinics were used, which included all STI clinic consultations carried out among heterosexual men and women between June 2014 and December 2015. Repeat testing was defined as returning to the same STI clinic between 35 days and 12 months after initial consultation. We calculated chlamydia positivity at repeat test stratified by initial test result and time between consultations. Logistic regression analyses were used to identify predictors of repeat testing, and predictors of having a chlamydia positive repeat test. In total, 140,486 consultations in 75,487 women and 46,286 men were available for analyses. Overall, 15.4% of women and 11.1% of men returned to the STI clinic within the study period. Highest chlamydia positivity at repeat test was seen 3-5 months after initial positive test. Among both women and men, repeat testing was associated with non-Western ethnicity, having had more than two sex partners in the past 6 months, reporting STI symptoms, having a history of STI, and having a chlamydia positive initial test. Among repeat testers, chlamydia positive repeat test was most strongly associated with younger age, followed by a chlamydia positive initial test. Repeat testing most often resulted in a positive test result among young heterosexuals (<25) and heterosexuals of any age with a chlamydia infection at the initial consultation. Further efforts are needed to determine optimal repeat testing strategies.

Clinically relevant diagnostic research in primary care: the example of B-type natriuretic peptides in the detection of heart failure.

PubMed

Kelder, Johannes C; Rutten, Frans H; Hoes, Arno W

2009-02-01

With the emergence of novel diagnostic tests, e.g. point-of-care tests, clinically relevant empirical evidence is needed to assess whether such a test should be used in daily practice. With the example of the value of B-type natriuretic peptides (BNP) in the diagnostic assessment of suspected heart failure, we will discuss the major methodological issues crucial in diagnostic research; most notably the choice of the study population and the data analysis with a multivariable approach. BNP have been studied extensively in the emergency care setting, and also several studies in the primary care are available. The usefulness of this test when applied in combination with other readily available tests is still not adequately addressed in the relevant patient domain, i.e. those who are clinically suspected of heart failure by their GP. Future diagnostic research in primary care should be targeted much more at answering the clinically relevant question 'Is it useful to add this (new) test to the other tests I usually perform, including history taking and physical examination, in patients I suspect of having a certain disease'.

Clinical utility of genetic testing in pediatric drug-resistant epilepsy: a pilot study.

PubMed

Ream, Margie A; Mikati, Mohamad A

2014-08-01

The utility of genetic testing in pediatric drug-resistant epilepsy (PDRE), its yield in "real life" clinical practice, and the practical implications of such testing are yet to be determined. To start to address the above gaps in our knowledge as they apply to a patient population seen in a tertiary care center. We retrospectively reviewed our experience with the use of clinically available genetic tests in the diagnosis and management of PDRE in one clinic over one year. Genetic testing included, depending on clinical judgment, one or more of the following: karyotype, chromosomal microarray, single gene sequencing, gene sequencing panels, and/or whole exome sequencing (WES). We were more likely to perform genetic testing in patients with developmental delay, epileptic encephalopathy, and generalized epilepsy. In our unique population, the yield of specific genetic diagnosis was relatively high: karyotype 14.3%, microarray 16.7%, targeted single gene sequencing 15.4%, gene panels 46.2%, and WES 16.7%. Overall yield of diagnosis from at least one of the above tests was 34.5%. Disease-causing mutations that were not clinically suspected based on the patients' phenotypes and representing novel phenotypes were found in 6.9% (2/29), with an additional 17.2% (5/29) demonstrating pharmacologic variants. Three patients were incidentally found to be carriers of recessive neurologic diseases (10.3%). Variants of unknown significance (VUSs) were identified in 34.5% (10/29). We conclude that genetic testing had at least some utility in our patient population of PDRE, that future similar larger studies in various populations are warranted, and that clinics offering such tests must be prepared to address the complicated questions raised by the results of such testing. Copyright © 2014. Published by Elsevier Inc.

ROC curves in clinical chemistry: uses, misuses, and possible solutions.

PubMed

Obuchowski, Nancy A; Lieber, Michael L; Wians, Frank H

2004-07-01

ROC curves have become the standard for describing and comparing the accuracy of diagnostic tests. Not surprisingly, ROC curves are used often by clinical chemists. Our aims were to observe how the accuracy of clinical laboratory diagnostic tests is assessed, compared, and reported in the literature; to identify common problems with the use of ROC curves; and to offer some possible solutions. We reviewed every original work using ROC curves and published in Clinical Chemistry in 2001 or 2002. For each article we recorded phase of the research, prospective or retrospective design, sample size, presence/absence of confidence intervals (CIs), nature of the statistical analysis, and major analysis problems. Of 58 articles, 31% were phase I (exploratory), 50% were phase II (challenge), and 19% were phase III (advanced) studies. The studies increased in sample size from phase I to III and showed a progression in the use of prospective designs. Most phase I studies were powered to assess diagnostic tests with ROC areas >/=0.70. Thirty-eight percent of studies failed to include CIs for diagnostic test accuracy or the CIs were constructed inappropriately. Thirty-three percent of studies provided insufficient analysis for comparing diagnostic tests. Other problems included dichotomization of the gold standard scale and inappropriate analysis of the equivalence of two diagnostic tests. We identify available software and make some suggestions for sample size determination, testing for equivalence in diagnostic accuracy, and alternatives to a dichotomous classification of a continuous-scale gold standard. More methodologic research is needed in areas specific to clinical chemistry.

Clinical review: Distinguishing constitutional delay of growth and puberty from isolated hypogonadotropic hypogonadism: critical appraisal of available diagnostic tests.

PubMed

Harrington, Jennifer; Palmert, Mark R

2012-09-01

Determining the etiology of delayed puberty during initial evaluation can be challenging. Specifically, clinicians often cannot distinguish constitutional delay of growth and puberty (CDGP) from isolated hypogonadotropic hypogonadism (IHH), with definitive diagnosis of IHH awaiting lack of spontaneous puberty by age 18 yr. However, the ability to make a timely, correct diagnosis has important clinical implications. The aim was to describe and evaluate the literature regarding the ability of diagnostic tests to distinguish CDGP from IHH. A PubMed search was performed using key words "puberty, delayed" and "hypogonadotropic hypogonadism," and citations within retrieved articles were reviewed to identify studies that assessed the utility of basal and stimulation tests in the diagnosis of delayed puberty. Emphasis was given to a test's ability to distinguish prepubertal adolescents with CDGP from those with IHH. Basal gonadotropin and GnRH stimulation tests have limited diagnostic specificity, with overlap in gonadotropin levels between adolescents with CDGP and IHH. Stimulation tests using more potent GnRH agonists and/or human chorionic gonadotropin may have better discriminatory value, but small study size, lack of replication of diagnostic thresholds, and prolonged protocols limit clinical application. A single inhibin B level in two recent studies demonstrated good differentiation between groups. Distinguishing IHH from CDGP is an important clinical issue. Basal inhibin B may offer a simple, discriminatory test if results from recent studies are replicated. However, current literature does not allow for recommendation of any diagnostic test for routine clinical use, making this an important area for future investigation.

Changes in pathology test ordering by early career general practitioners: a longitudinal study.

PubMed

Magin, Parker J; Tapley, Amanda; Morgan, Simon; Henderson, Kim; Holliday, Elizabeth G; Davey, Andrew R; Ball, Jean; Catzikiris, Nigel F; Mulquiney, Katie J; van Driel, Mieke L

2017-07-17

To assess the number of pathology tests ordered by general practice registrars during their first 18-24 months of clinical general practice. Longitudinal analysis of ten rounds of data collection (2010-2014) for the Registrar Clinical Encounters in Training (ReCEnT) study, an ongoing, multicentre, cohort study of general practice registrars in Australia. The principal analysis employed negative binomial regression in a generalised estimating equations framework (to account for repeated measures on registrars).Setting, participants: General practice registrars in training posts with five of 17 general practice regional training providers in five Australian states. The registrar participation rate was 96.4%. Number of pathology tests requested per consultation. The time unit for analysis was the registrar training term (the 6-month full-time equivalent component of clinical training); registrars contributed data for up to four training terms. 876 registrars contributed data for 114 584 consultations. The number of pathology tests requested increased by 11% (95% CI, 8-15%; P < 0.001) per training term. Contrary to expectations, pathology test ordering by general practice registrars increased significantly during their first 2 years of clinical practice. This causes concerns about overtesting. As established general practitioners order fewer tests than registrars, test ordering may peak during late vocational training and early career practice. Registrars need support during this difficult period in the development of their clinical practice patterns.

Patient characteristics driving clinical utility in psychiatric pharmacogenetics: a reanalysis from the AB-GEN multicentric trial.

PubMed

Menchón, J M; Espadaler, J; Tuson, M; Saiz-Ruiz, J; Bobes, J; Vieta, E; Álvarez, E; Pérez, V

2018-05-04

Clinical utility of commercial multi-gene pharmacogenetic tests in depression is starting to be studied with some promising results on efficacy and tolerability. Among the next steps is the definition of the patient profile that is most likely to benefit from testing. Here we present a reanalysis of data from the AB-GEN randomized clinical trial showing that clinical utility of pharmacogenetic testing can be markedly influenced by patient characteristics such as age, baseline severity and duration of current depressive episode.Trial registration ClinicalTrials.gov NCT02529462.

Examining the postural awareness and flexibility changes in physical therapy students who took clinical Pilates class.

PubMed

Atilgan, Esra; Tarakci, Devrim; Mutluay, Fatma

2017-01-01

This study aimed to evaluate postural awareness and changes in posture and flexibility of students who took Clinical Pilates class as an elective course at the undergraduate level. The study conducted from 2013-2016 included 98 students who took Clinical Pilates class at the Department of Physical Therapy and Rehabilitation, School of Health Sciences, Istanbul Medipol University, Turkey. The flexibility levels of the study participants were measured before and after the Clinical Pilates education using finger-to-floor test and modified Schober's test. Observational posture analysis and postural awareness were recorded using the scale prepared by the researchers. The post-education evaluations showed that postural distortions were fixed, and a significant increase in the postural awareness of the students was observed compared with the pre-education period. The results of both modified Schober's test and finger-to-floor test, which were used to measure the flexibility levels, showed a statistically significant increase in post-education scores compared with those of the pre-education period. This study showed that the Clinical Pilates course increased postural awareness and flexibility of physical therapy students and fixed postural distortions. Thus, the inclusion of Clinical Pilates class in the undergraduate education is considered to be important.

Examining the postural awareness and flexibility changes in physical therapy students who took clinical Pilates class

PubMed Central

Atilgan, Esra; Tarakci, Devrim; Mutluay, Fatma

2017-01-01

Objective: This study aimed to evaluate postural awareness and changes in posture and flexibility of students who took Clinical Pilates class as an elective course at the undergraduate level. Methods: The study conducted from 2013-2016 included 98 students who took Clinical Pilates class at the Department of Physical Therapy and Rehabilitation, School of Health Sciences, Istanbul Medipol University, Turkey. The flexibility levels of the study participants were measured before and after the Clinical Pilates education using finger-to-floor test and modified Schober’s test. Observational posture analysis and postural awareness were recorded using the scale prepared by the researchers. Results: The post-education evaluations showed that postural distortions were fixed, and a significant increase in the postural awareness of the students was observed compared with the pre-education period. The results of both modified Schober’s test and finger-to-floor test, which were used to measure the flexibility levels, showed a statistically significant increase in post-education scores compared with those of the pre-education period. Conclusion: This study showed that the Clinical Pilates course increased postural awareness and flexibility of physical therapy students and fixed postural distortions. Thus, the inclusion of Clinical Pilates class in the undergraduate education is considered to be important. PMID:28811786

A quick behavioral dichotic word test is prognostic for clinical response to cognitive therapy for depression: A replication study.

PubMed

Bruder, Gerard E; Haggerty, Agnes; Siegle, Greg J

2017-02-01

There are no commonly used clinical indicators of whether an individual will benefit from cognitive therapy (CT) for depression. A prior study found right ear (left hemisphere) advantage for perceiving dichotic words predicted CT response. This study replicates this finding at a different research center in clinical trials that included clinically representative samples and community therapists. Right-handed individuals with unipolar major depressive disorder who subsequently received 12-14 weeks of CT at the University of Pittsburgh were tested on dichotic fused words and complex tones tests. Responders to CT showed twice the mean right ear advantage in dichotic fused words performance than non-responders. Patients with a right ear advantage greater than the mean for healthy controls had an 81% response rate to CT, whereas those with performance lower than the mean for controls had a 46% response rate. Individuals with a right ear advantage, indicative of strong left hemisphere language dominance, may be better at utilizing cognitive processes and left frontotemporal cortical regions critical for success of CT for depression. Findings at two clinical research centers suggest that verbal dichotic listening may be a clinically disseminative brief, inexpensive and easily automated test prognostic for response to CT across diverse clinical settings. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Vestibular Assessments in Children With Global Developmental Delay: An Exploratory Study.

PubMed

Dannenbaum, Elizabeth; Horne, Victoria; Malik, Farwa; Villeneuve, Myriam; Salvo, Lora; Chilingaryan, Gevorg; Lamontagne, Anouk

2016-01-01

To compare results of 3 clinical vestibular tests between children with global developmental delay (GDD) and children with typical development (TD) and investigate the test-retest reliability. Twenty children with GDD (aged 4.1-12.1 years) and 11 age-matched controls with TD participated. Participants with GDD underwent 2 sessions of testing. Each session consisted of the Clinical Test of Sensory Interaction and Balance (CTSIB), Dynamic Visual Acuity (DVA) test, and the modified Emory Clinical Vestibular Chair Test (m-ECVCT). Up to 33% of the children with GDD had abnormal DVA scores. m-ECVCT results of children with GDD demonstrated larger variance than children with TD. The CTSIB score was significantly reduced in the group with GDD. The test-retest reliability varied, with good reliability for the m-ECVCT and CTSIB, and fair reliability for the DVA. Findings suggest vestibular involvement in children in GDD. The clinical tests demonstrated moderate test-retest reliability.

Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis.

PubMed

Schwebke, Jane R; Gaydos, Charlotte A; Nyirjesy, Paul; Paradis, Sonia; Kodsi, Salma; Cooper, Charles K

2018-06-01

Vaginitis is a common complaint, diagnosed either empirically or using Amsel's criteria and wet mount microscopy. This study sought to determine characteristics of an investigational test (a molecular test for vaginitis), compared to reference, for detection of bacterial vaginosis, Candida spp., and Trichomonas vaginalis Vaginal specimens from a cross-sectional study were obtained from 1,740 women (≥18 years old), with vaginitis symptoms, during routine clinic visits (across 10 sites in the United States). Specimens were analyzed using a commercial PCR/fluorogenic probe-based investigational test that detects bacterial vaginosis, Candida spp., and Trichomonas vaginalis Clinician diagnosis and in-clinic testing (Amsel's test, potassium hydroxide preparation, and wet mount) were also employed to detect the three vaginitis causes. All testing methods were compared to the respective reference methods (Nugent Gram stain for bacterial vaginosis, detection of the Candida gene its2 , and Trichomonas vaginalis culture). The investigational test, clinician diagnosis, and in-clinic testing were compared to reference methods for bacterial vaginosis, Candida spp., and Trichomonas vaginalis The investigational test resulted in significantly higher sensitivity and negative predictive value than clinician diagnosis or in-clinic testing. In addition, the investigational test showed a statistically higher overall percent agreement with each of the three reference methods than did clinician diagnosis or in-clinic testing. The investigational test showed significantly higher sensitivity for detecting vaginitis, involving more than one cause, than did clinician diagnosis. Taken together, these results suggest that a molecular investigational test can facilitate accurate detection of vaginitis. Copyright © 2018 Schwebke et al.

Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.

PubMed

Cho, Alex H; Killeya-Jones, Ley A; O'Daniel, Julianne M; Kawamoto, Kensaku; Gallagher, Patrick; Haga, Susanne; Lucas, Joseph E; Trujillo, Gloria M; Joy, Scott V; Ginsburg, Geoffrey S

2012-01-18

Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT) assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA) for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm), or the SRA alone ("SRA" arm). Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm). Risk counseling is provided by clinic staff (not study staff external to the clinic). Fasting plasma glucose, insulin levels, body mass index (BMI), and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk information in a primary care setting can help improve patients' clinical outcomes, risk perceptions, and/or their engagement in healthy behavior change. In addition, study design features such as the use of existing clinic personnel for risk counseling could inform the future development and implementation of care models for the use of individual genetic risk information in primary care. ClinicalTrials.gov: NCT00849563.

Effect of home testing of international normalized ratio on clinical events.

PubMed

Matchar, David B; Jacobson, Alan; Dolor, Rowena; Edson, Robert; Uyeda, Lauren; Phibbs, Ciaran S; Vertrees, Julia E; Shih, Mei-Chiung; Holodniy, Mark; Lavori, Philip

2010-10-21

Warfarin anticoagulation reduces thromboembolic complications in patients with atrial fibrillation or mechanical heart valves, but effective management is complex, and the international normalized ratio (INR) is often outside the target range. As compared with venous plasma testing, point-of-care INR measuring devices allow greater testing frequency and patient involvement and may improve clinical outcomes. We randomly assigned 2922 patients who were taking warfarin because of mechanical heart valves or atrial fibrillation and who were competent in the use of point-of-care INR devices to either weekly self-testing at home or monthly high-quality testing in a clinic. The primary end point was the time to a first major event (stroke, major bleeding episode, or death). The patients were followed for 2.0 to 4.75 years, for a total of 8730 patient-years of follow-up. The time to the first primary event was not significantly longer in the self-testing group than in the clinic-testing group (hazard ratio, 0.88; 95% confidence interval, 0.75 to 1.04; P=0.14). The two groups had similar rates of clinical outcomes except that the self-testing group reported more minor bleeding episodes. Over the entire follow-up period, the self-testing group had a small but significant improvement in the percentage of time during which the INR was within the target range (absolute difference between groups, 3.8 percentage points; P<0.001). At 2 years of follow-up, the self-testing group also had a small but significant improvement in patient satisfaction with anticoagulation therapy (P=0.002) and quality of life (P<0.001). As compared with monthly high-quality clinic testing, weekly self-testing did not delay the time to a first stroke, major bleeding episode, or death to the extent suggested by prior studies. These results do not support the superiority of self-testing over clinic testing in reducing the risk of stroke, major bleeding episode, and death among patients taking warfarin therapy. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT00032591.).

The clinical effectiveness and cost-effectiveness of testing for cytochrome P450 polymorphisms in patients with schizophrenia treated with antipsychotics: a systematic review and economic evaluation.

PubMed

Fleeman, N; McLeod, C; Bagust, A; Beale, S; Boland, A; Dundar, Y; Jorgensen, A; Payne, K; Pirmohamed, M; Pushpakom, S; Walley, T; de Warren-Penny, P; Dickson, R

2010-01-01

To determine whether testing for cytochrome P450 (CYP) polymorphisms in adults entering antipsychotic treatment for schizophrenia leads to improvement in outcomes, is useful in medical, personal or public health decision-making, and is a cost-effective use of health-care resources. The following electronic databases were searched for relevant published literature: Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, EMBASE, Health Technology Assessment database, ISI Web of Knowledge, MEDLINE, PsycINFO, NHS Economic Evaluation Database, Health Economic Evaluation Database, Cost-effectiveness Analysis (CEA) Registry and the Centre for Health Economics website. In addition, publicly available information on various genotyping tests was sought from the internet and advisory panel members. A systematic review of analytical validity, clinical validity and clinical utility of CYP testing was undertaken. Data were extracted into structured tables and narratively discussed, and meta-analysis was undertaken when possible. A review of economic evaluations of CYP testing in psychiatry and a review of economic models related to schizophrenia were also carried out. For analytical validity, 46 studies of a range of different genotyping tests for 11 different CYP polymorphisms (most commonly CYP2D6) were included. Sensitivity and specificity were high (99-100%). For clinical validity, 51 studies were found. In patients tested for CYP2D6, an association between genotype and tardive dyskinesia (including Abnormal Involuntary Movement Scale scores) was found. The only other significant finding linked the CYP2D6 genotype to parkinsonism. One small unpublished study met the inclusion criteria for clinical utility. One economic evaluation assessing the costs and benefits of CYP testing for prescribing antidepressants and 28 economic models of schizophrenia were identified; none was suitable for developing a model to examine the cost-effectiveness of CYP testing. Tests for determining genotypes appear to be accurate although not all aspects of analytical validity were reported. Given the absence of convincing evidence from clinical validity studies, the lack of clinical utility and economic studies, and the unsuitability of published schizophrenia models, no model was developed; instead key features and data requirements for economic modelling are presented. Recommendations for future research cover both aspects of research quality and data that will be required to inform the development of future economic models.

Validation of Mismatch Negativity and P3a for Use in Multi-Site Studies of Schizophrenia: Characterization of Demographic, Clinical, Cognitive, and Functional Correlates in COGS-2

PubMed Central

Light, Gregory A.; Swerdlow, Neal R.; Thomas, Michael L.; Calkins, Monica E.; Green, Michael F.; Greenwood, Tiffany A.; Gur, Raquel E.; Gur, Ruben C.; Lazzeroni, Laura C.; Nuechterlein, Keith H.; Pela, Marlena; Radant, Allen D.; Seidman, Larry J.; Sharp, Richard F.; Siever, Larry J.; Silverman, Jeremy M.; Sprock, Joyce; Stone, William S.; Sugar, Catherine A.; Tsuang, Debby W.; Tsuang, Ming T.; Braff, David L.; Turetsky, Bruce I.

2014-01-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP data was obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. PMID:25449710

Validation of mismatch negativity and P3a for use in multi-site studies of schizophrenia: characterization of demographic, clinical, cognitive, and functional correlates in COGS-2.

PubMed

Light, Gregory A; Swerdlow, Neal R; Thomas, Michael L; Calkins, Monica E; Green, Michael F; Greenwood, Tiffany A; Gur, Raquel E; Gur, Ruben C; Lazzeroni, Laura C; Nuechterlein, Keith H; Pela, Marlena; Radant, Allen D; Seidman, Larry J; Sharp, Richard F; Siever, Larry J; Silverman, Jeremy M; Sprock, Joyce; Stone, William S; Sugar, Catherine A; Tsuang, Debby W; Tsuang, Ming T; Braff, David L; Turetsky, Bruce I

2015-04-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP recordings were obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. Published by Elsevier B.V.

INHERITED NEUROPATHIES: CLINICAL OVERVIEW AND UPDATE

PubMed Central

KLEIN, CHRISTOPHER J.; DUAN, XIAOHUI; SHY, MICHAEL E.

2014-01-01

Inherited neuropathy is a group of common neurologic disorders with heterogeneous clinical presentations and genetic causes. Detailed neuromuscular evaluations, including nerve conduction studies, laboratory testing, and histopathologic examination, can assist in identification of the inherited component beyond family history. Genetic testing increasingly enables definitive diagnosis of specific inherited neuropathies. Diagnosis, however, is often complex, and neurologic disability may have both genetic and acquired components in individual patients. The decision of which genetic test to order or whether to order genetic tests is often complicated, and the strategies to maximize the value of testing are evolving. Apart from rare inherited metabolic neuropathies, treatment approaches remain largely supportive. We provide a clinical update of the various types of inherited neuropathies, their differential diagnoses, and distinguishing clinical features (where available). A framework is provided for clinical evaluations, including the inheritance assessment, electrophysiologic examinations, and specific genetic tests. PMID:23801417

Comparison of two commercial rapid in-clinic serological tests for detection of antibodies against Leishmania spp. in dogs.

PubMed

Athanasiou, Labrini V; Petanides, Theodoros A; Chatzis, Manolis K; Kasabalis, Dimitrios; Apostolidis, Kosmas N; Saridomichelakis, Manolis N

2014-03-01

Antibodies against Leishmania spp. are detected in most dogs with clinical signs of leishmaniasis due to Leishmania infantum. Accurate, rapid in-clinic serological tests may permit immediate confirmation of the diagnosis and implementation of therapeutic measures. The aim of the current study was to evaluate the diagnostic accuracy of 2 commercial, rapid in-clinic serological tests for the detection of anti-Leishmania antibodies in sera of dogs, the Snap Canine Leishmania Antibody Test kit (IDEXX Laboratories Inc., Westbrook, Maine) and the ImmunoRun Antibody Detection kit (Biogal Galed Labs, Kibbutz Galed, Israel), using indirect fluorescent antibody test (IFAT) as the reference method. A total of 109 sera collected from 65 seropositive and 44 seronegative dogs were used. The sensitivities of the Snap and ImmunoRun kits were 89.23% (95% confidence interval: 79.05-95.54%) and 86.15% (95% confidence interval: 75.33-93.45%), respectively, and the specificity of both tests was 100%. A good agreement between each of the rapid in-clinic serological tests and IFAT and between the 2 rapid in-clinic serological tests was witnessed. Both rapid in-clinic serological tests showed an adequate diagnostic accuracy and can be used for the fast detection of antibodies against L. infantum in dogs.

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.

A novel suction/coagulation integrated probe for achieving better hemostasis: development and clinical use.

PubMed

Takahashi, Hidekazu; Haraguchi, Naotsugu; Nishimura, Junichi; Hata, Taishi; Matsuda, Chu; Yamamoto, Hirofumi; Mizushima, Tsunekazu; Mori, Masaki; Doki, Yuichiro; Nakajima, Kiyokazu

2018-06-01

Modern electrosurgical tools have a specific coagulation mode called "soft coagulation". However, soft coagulation has not been widely accepted for surgical operations. To optimize the soft coagulation environment, we developed a novel suction device integrated with an electrosurgical probe, called the "Suction ball coagulator" (SBC). In this study, we aimed to optimize the SBC design with a prototyping process involving a bench test and preclinical study; then, we aimed to demonstrate the feasibility, safety, and potential effectiveness of the SBC for laparoscopic surgery in clinical settings. SBC prototyping was performed with a bench test. Device optimization was performed in a preclinical study with a domestic swine bleeding model. Then, SBC was tested in a clinical setting during 17 clinical laparoscopic colorectal surgeries. In the bench tests, two tip hole sizes and patterns showed a good suction capacity. The preclinical study indicated the best tip shape for accuracy. In clinical use, no device-related adverse event was observed. Moreover, the SBC was feasible for prompt hemostasis and blunt dissections. In addition, SBC could evacuate vapors generated by tissue ablation using electroprobe during laparoscopic surgery. We successfully developed a novel, integrated suction/coagulation probe for hemostasis and commercialized it.

Further examination of embedded performance validity indicators for the Conners' Continuous Performance Test and Brief Test of Attention in a large outpatient clinical sample.

PubMed

Sharland, Michael J; Waring, Stephen C; Johnson, Brian P; Taran, Allise M; Rusin, Travis A; Pattock, Andrew M; Palcher, Jeanette A

2018-01-01

Assessing test performance validity is a standard clinical practice and although studies have examined the utility of cognitive/memory measures, few have examined attention measures as indicators of performance validity beyond the Reliable Digit Span. The current study further investigates the classification probability of embedded Performance Validity Tests (PVTs) within the Brief Test of Attention (BTA) and the Conners' Continuous Performance Test (CPT-II), in a large clinical sample. This was a retrospective study of 615 patients consecutively referred for comprehensive outpatient neuropsychological evaluation. Non-credible performance was defined two ways: failure on one or more PVTs and failure on two or more PVTs. Classification probability of the BTA and CPT-II into non-credible groups was assessed. Sensitivity, specificity, positive predictive value, and negative predictive value were derived to identify clinically relevant cut-off scores. When using failure on two or more PVTs as the indicator for non-credible responding compared to failure on one or more PVTs, highest classification probability, or area under the curve (AUC), was achieved by the BTA (AUC = .87 vs. .79). CPT-II Omission, Commission, and Total Errors exhibited higher classification probability as well. Overall, these findings corroborate previous findings, extending them to a large clinical sample. BTA and CPT-II are useful embedded performance validity indicators within a clinical battery but should not be used in isolation without other performance validity indicators.

Clinical study in genital herpes: natural Gene-Eden-VIR/Novirin versus acyclovir, valacyclovir, and famciclovir.

PubMed

Polansky, Hanan; Javaherian, Adrian; Itzkovitz, Edan

2016-01-01

This paper reports the results of a clinical study that tested the effect of suppressive treatment with the botanical product Gene-Eden-VIR/Novirin on the number of genital herpes outbreaks. The results in this study were compared to those published in clinical studies of acyclovir, valacyclovir, and famciclovir. The framework was a retrospective chart review. The population included 139 participants. The treatment was one to four capsules of Gene-Eden-VIR/Novirin per day. The duration of treatment was 2-48 months. The study included three controls recommended by the US Food and Drug Administration (FDA): baseline, no treatment, and dose response. The treatment decreased the number of outbreaks per year in 90.8% of the participants. The treatment also decreased the mean number of outbreaks per year from 7.27 and 5.5 in the control groups to 2.39 (P<0.0001 and P<0.001, respectively). The treated participants reported no adverse experiences. Out of the 15 tests that compared Gene-Eden-VIR/Novirin to the three drugs, Gene-Eden-VIR/Novirin had superior efficacy in eight tests, inferior efficacy in three tests, and comparable efficacy in four tests. Gene-Eden-VIR/Novirin also had superior safety. The clinical study showed that the natural Gene-Eden-VIR/Novirin decreases the number of genital herpes outbreaks without any side effects. The study also showed that the clinical effects reported in this study are mostly better than those reported in the reviewed studies of acyclovir, valacyclovir, and famciclovir.

Corrections of clinical chemistry test results in a laboratory information system.

PubMed

Wang, Sihe; Ho, Virginia

2004-08-01

The recently released reports by the Institute of Medicine, To Err Is Human and Patient Safety, have received national attention because of their focus on the problem of medical errors. Although a small number of studies have reported on errors in general clinical laboratories, there are, to our knowledge, no reported studies that focus on errors in pediatric clinical laboratory testing. To characterize the errors that have caused corrections to have to be made in pediatric clinical chemistry results in the laboratory information system, Misys. To provide initial data on the errors detected in pediatric clinical chemistry laboratories in order to improve patient safety in pediatric health care. All clinical chemistry staff members were informed of the study and were requested to report in writing when a correction was made in the laboratory information system, Misys. Errors were detected either by the clinicians (the results did not fit the patients' clinical conditions) or by the laboratory technologists (the results were double-checked, and the worksheets were carefully examined twice a day). No incident that was discovered before or during the final validation was included. On each Monday of the study, we generated a report from Misys that listed all of the corrections made during the previous week. We then categorized the corrections according to the types and stages of the incidents that led to the corrections. A total of 187 incidents were detected during the 10-month study, representing a 0.26% error detection rate per requisition. The distribution of the detected incidents included 31 (17%) preanalytic incidents, 46 (25%) analytic incidents, and 110 (59%) postanalytic incidents. The errors related to noninterfaced tests accounted for 50% of the total incidents and for 37% of the affected tests and orderable panels, while the noninterfaced tests and panels accounted for 17% of the total test volume in our laboratory. This pilot study provided the rate and categories of errors detected in a pediatric clinical chemistry laboratory based on the corrections of results in the laboratory information system. A direct interface of the instruments to the laboratory information system showed that it had favorable effects on reducing laboratory errors.

The Behind-the-Knee test: an efficient model for evaluating mechanical and chemical irritation.

PubMed

Farage, Miranda A

2006-05-01

The 'Behind-the-Knee' method (BTK test), using the popliteal fossa as a test site, evaluates both the inherent chemical irritation, and the potential for mechanical irritation of substrates and products. This approach eliminates some of the difficulties of in-use clinical test systems while still providing reliable results. In this publication, examples of the results of BTK tests on several materials are presented with direct comparisons, where possible, with results of in-use clinical testing conducted on the same materials. In in-use clinical tests, volunteer panelists were provided with catamenial products to use in place of their normal product. In the BTK test, samples were applied daily to the popliteal fossa using an elastic athletic band. In both studies, irritation reactions were scored visually. Levels of irritation in the BTK test are consistently higher than those of standard patch tests, illustrating the contribution of mechanical irritation to the overall irritant potential of materials and products. Repeated tests on identical test materials demonstrated that the BTK test results are reproducible. Side-by-side comparisons of the BTK test and in-use clinical tests demonstrated that the BTK test produces results of similar quality to the in-use clinical. By using several concurrent panels with a common test material, it is possible to compare the irritant properties of several materials at once. We have tested over 25 different materials in over 35 BTK studies. The test method has proven reliable and versatile in testing a wide variety of materials, including menstrual pads, topsheets, interlabial pads, pantiliners, tampons and lotion coatings on products. Unlike in-use clinicals, the BTK test allows the direct comparison of two products at one time on the same individual, and is easily adapted to investigative programs. It is subject to fewer confounding factors, is much easier to implement, has a shorter turnaround time, and is less expensive than in-use clinical testing. Importantly, unlike standard patch tests, the BTK test evaluates both the inherent chemical irritation associated with materials and the mechanical irritation owing to friction. Although the BTK test was developed using catamenial products, the test system provides a valuable alternative for evaluating any material where mechanical irritation may play a role, including textiles, facial tissues, baby and adult diapers, and laundry products that may leave residues on fabrics.

Does sensitivity measured from screening test-sets predict clinical performance?

NASA Astrophysics Data System (ADS)

Soh, BaoLin P.; Lee, Warwick B.; Mello-Thoms, Claudia R.; Tapia, Kriscia A.; Ryan, John; Hung, Wai Tak; Thompson, Graham J.; Heard, Rob; Brennan, Patrick C.

2014-03-01

Aim: To examine the relationship between sensitivity measured from the BREAST test-set and clinical performance. Background: Although the UK and Australia national breast screening programs have regarded PERFORMS and BREAST test-set strategies as possible methods of estimating readers' clinical efficacy, the relationship between test-set and real life performance results has never been satisfactorily understood. Methods: Forty-one radiologists from BreastScreen New South Wales participated in this study. Each reader interpreted a BREAST test-set which comprised sixty de-identified mammographic examinations sourced from the BreastScreen Digital Imaging Library. Spearman's rank correlation coefficient was used to compare the sensitivity measured from the BREAST test-set with screen readers' clinical audit data. Results: Results shown statistically significant positive moderate correlations between test-set sensitivity and each of the following metrics: rate of invasive cancer per 10 000 reads (r=0.495; p < 0.01); rate of small invasive cancer per 10 000 reads (r=0.546; p < 0.001); detection rate of all invasive cancers and DCIS per 10 000 reads (r=0.444; p < 0.01). Conclusion: Comparison between sensitivity measured from the BREAST test-set and real life detection rate demonstrated statistically significant positive moderate correlations which validated that such test-set strategies can reflect readers' clinical performance and be used as a quality assurance tool. The strength of correlation demonstrated in this study was higher than previously found by others.

Evaluation of a Novel Single-Tube Method for Extended Genotyping of Human Papillomavirus

PubMed Central

Serrano, I.; Wennington, H.; Graham, C.; Cubie, H.; Boland, E.; Fu, G.; Cuschieri, K.

2017-01-01

ABSTRACT The use of high-risk human papillomavirus (HPV) testing for surveillance and clinical applications is increasing globally, and it is important that tests are evaluated to ensure they are fit for this purpose. In this study, the performance of a new HPV genotyping test, the Papilloplex high-risk HPV (HR-HPV) test, was compared to two well-established genotyping tests. Preliminary clinical performance was also ascertained for the detection of CIN2+ in a disease-enriched retrospective cohort. A panel of 500 cervical liquid-based cytology samples with known clinical outcomes were tested by the Papilloplex HR-HPV test. Analytical concordance was compared to two assays: a Linear Array (LA) HPV genotyping test and an Optiplex HPV genotyping test. The initial clinical performance for the detection for CIN2+ samples was performed and compared to that of two clinically validated HPV tests: a RealTime High-Risk HPV test (RealTime) and a Hybrid Capture 2 HPV test (HC2). High agreement for HR-HPV was observed between the Papilloplex and LA and Optiplex HPV tests (97 and 95%, respectively), with kappa values for HPV16 and HPV18 being 0.90 and 0.81 compared to the LA and 0.70 and 0.82 compared to the Optiplex test. The sensitivity, specificity, positive predictive value, and negative predictive value of the Papilloplex test for the detection of CIN2+ were 92, 54, 33, and 96%, respectively, and very similar to the values observed with RealTime and HC2. The Papilloplex HR-HPV test demonstrated a analytical performance similar to those of the two HPV genotyping tests at the HR-HPV level and the type-specific level. The preliminary data on clinical performance look encouraging, although further longitudinal studies within screening populations are required to confirm these findings. PMID:29237790

SFEMG in ocular myasthenia gravis diagnosis.

PubMed

Padua, L; Stalberg, E; LoMonaco, M; Evoli, A; Batocchi, A; Tonali, P

2000-07-01

In typical cases, the patient's history and clinical examination make it possible to diagnose ocular myasthenia gravis (OMG). But, in many cases a clear clinical picture is not present and OMG diagnosis is very difficult because gold diagnostic standard tests are not available. The diagnostic tests for OMG are usually unable to display a good sensitivity and specificity simultaneously. In this paper, we studied 86 cases submitted for suspected OMG. The patients were studied clinically and with various other tests used in OMG diagnosis (SFEMG, repetitive nerve stimulation, Ab anti AChR titration, tensilon test). SFEMG showed the highest sensitivity (100%) while Ab anti AChR showed the highest specificity (100%). To our knowledge this is the largest population of suspected OMG studied using most of the diagnostic parameters, reported in the literature.

Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

PubMed

Logvinov, Ilana

2014-03-01

Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

Diagnosis of vulvovaginitis: comparison of clinical and microbiological diagnosis.

PubMed

Esim Buyukbayrak, Esra; Kars, Bulent; Karsidag, Ayse Yasemin Karageyim; Karadeniz, Bernan Ilkay; Kaymaz, Ozge; Gencer, Serap; Pirimoglu, Zehra Meltem; Unal, Orhan; Turan, Mehmet Cem

2010-11-01

The purpose of the present study was to compare the current diagnostic clinical and laboratory approaches to women with vulvovaginal discharge complaint. The secondary outcomes were to determine the prevalence of infections in our setting and to look for the relation between vulvovaginal infections and predisposing factors if present. Premenopausal women applying to our gynecology outpatient clinic with vaginal discharge complaint were enrolled prospectively into the study. Each patient evaluated clinically with direct observation of vaginal secretions, wet mount examination, whiff test, vaginal pH testing and chlamydia rapid antigen test. Each patient also evaluated microbiologically with vaginal discharge culture and gram staining. Clinical diagnosis was compared with the microbiological diagnosis (the gold standard). Diagnostic accuracy was measured with sensitivity, specificity, positive (ppv) and negative predictive values (npv). 460 patients were included in the study. 89.8% of patients received a clinical diagnosis whereas only 36% of them had microbiological diagnosis. The sensitivity, specificity, ppv, npv of clinical diagnosis over microbiological culture results were 95, 13, 38, 82%, respectively. The most commonly encountered microorganisms by culture were Candida species (17.4%) and Gardnerella vaginalis (10.2%). Clinically, the most commonly made diagnoses were mixed infection (34.1%), bacterial vaginosis (32.4%) and fungal infection (14.1%). Symptoms did not predict laboratory results. Predisposing factors (DM, vaginal douching practice, presence of IUD and usage of oral contraceptive pills) were not found to be statistically important influencing factors for vaginal infections. Clinical diagnosis based on combining symptoms with office-based testing improves diagnostic accuracy but is insufficient. The most effective approach also incorporates laboratory testing as an adjunct when a diagnosis is in question or treatment is failing.

Clinical classification and neuro-vestibular evaluation in chronic dizziness.

PubMed

Oh, Sun-Young; Kim, Do-Hyung; Yang, Tae-Ho; Shin, Byoung-Soo; Jeong, Seul-Ki

2015-01-01

This study attempts to clarify the clinical characteristics of chronic dizziness and its relationships with specific vestibular, oculomotor, autonomic and psychiatric dysfunctions. 73 Patients with idiopathic chronic dizziness were recruited and classified based on history taking and clinical examination into the following four clinical subgroups; vestibular migraine (VM), dysautonomia, psychogenic, and unspecified groups. They were also evaluated using oculomotor, otolithic and autonomic function tests, and psychologic investigation. Patients in the VM group showed a high proportion of abnormality on smooth pursuit and otolithic function testing compared to the other groups. The dysautonomia group revealed significant abnormalities in sympathetic and cardiovagal autonomic function, while the psychogenic group had a high frequency of abnormality in sympathetic autonomic testing and in Beck's anxiety inventory scale. The unspecified group showed abnormalities on saccade, smooth pursuit and autonomic function testing. Clinical classification of patients with chronic dizziness was relevant and they showed a correlation with disease-specific abnormal results in oculomotor, otolithic, autonomic function and psychology testing. Appropriate diagnostic investigation based on precise clinical diagnosis of chronic dizziness reduces the need for extensive laboratory testing, neuroimaging, and other low-yield tests. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

A comprehensive test of clinical reasoning for medical students: An olympiad experience in Iran.

PubMed

Monajemi, Alireza; Arabshahi, Kamran Soltani; Soltani, Akbar; Arbabi, Farshid; Akbari, Roghieh; Custers, Eugene; Hadadgar, Arash; Hadizadeh, Fatemeh; Changiz, Tahereh; Adibi, Peyman

2012-01-01

Although some tests for clinical reasoning assessment are now available, the theories of medical expertise have not played a major role in this filed. In this paper, illness script theory was chose as a theoretical framework and contemporary clinical reasoning tests were put together based on this theoretical model. This paper is a qualitative study performed with an action research approach. This style of research is performed in a context where authorities focus on promoting their organizations' performance and is carried out in the form of teamwork called participatory research. Results are presented in four parts as basic concepts, clinical reasoning assessment, test framework, and scoring. we concluded that no single test could thoroughly assess clinical reasoning competency, and therefore a battery of clinical reasoning tests is needed. This battery should cover all three parts of clinical reasoning process: script activation, selection and verification. In addition, not only both analytical and non-analytical reasoning, but also both diagnostic and management reasoning should evenly take into consideration in this battery. This paper explains the process of designing and implementing the battery of clinical reasoning in the Olympiad for medical sciences students through an action research.

American Association for Clinical Chemistry

MedlinePlus

... did not need additional cardiac testing. Read the study LAB TESTS ONLINE USPSTF Updates Draft Recommendations on Cervical Cancer ... to follow colleagues and receive updates when they post in a forum, as well as enhanced email and messaging tools. Search ... AACC Programs and Partners Lab Tests Online Harmonization.net Commission on Accreditation in Clinical ...

Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial

PubMed Central

Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

2016-01-01

[Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists. PMID:27134355

Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial.

PubMed

Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

2016-03-01

[Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists.

Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis.

PubMed

Ward, S; Scope, A; Rafia, R; Pandor, A; Harnan, S; Evans, P; Wyld, L

2013-10-01

Gene expression profiling (GEP) and expanded immunohistochemistry (IHC) tests aim to improve decision-making relating to adjuvant chemotherapy for women with early breast cancer. The aim of this report is to assess the clinical effectiveness and cost-effectiveness of nine GEP and expanded IHC tests compared with current prognostic tools in guiding the use of adjuvant chemotherapy in patients with early breast cancer in England and Wales. The nine tests are BluePrint, Breast Cancer Index (BCI), IHC4, MammaPrint, Mammostrat, NPI plus (NPI+), OncotypeDX, PAM50 and Randox Breast Cancer Array. Databases searched included MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE and The Cochrane Library. Databases were searched from January 2009 to May 2011 for the OncotypeDX and MammaPrint tests and from January 2002 to May 2011 for the other tests. A systematic review of the evidence on clinical effectiveness (analytical validity, clinical validity and clinical utility) and cost-effectiveness was conducted. An economic model was developed to evaluate the cost-effectiveness of adjuvant chemotherapy treatment guided by four of the nine test (OncotypeDX, IHC4, MammaPrint and Mammostrat) compared with current clinical practice in England and Wales, using clinicopathological parameters, in women with oestrogen receptor-positive (ER+), lymph node-negative (LN-), human epidermal growth factor receptor type 2-negative (HER2-) early breast cancer. The literature searches for clinical effectiveness identified 5993 citations, of which 32 full-text papers or abstracts (30 studies) satisfied the criteria for the effectiveness review. A narrative synthesis was performed. Evidence for OncotypeDX supported the prognostic capability of the test. There was some evidence on the impact of the test on decision-making and to support the case that OncotypeDX predicts chemotherapy benefit; however, few studies were UK based and limitations in relation to study design were identified. Evidence for MammaPrint demonstrated that the test score was a strong independent prognostic factor, but the evidence is non-UK based and is based on small sample sizes. Evidence on the Mammostrat test showed that the test was an independent prognostic tool for women with ER+, tamoxifen-treated breast cancer. The three studies appeared to be of reasonable quality and provided data from a UK setting (one study). One large study reported on clinical validity of the IHC4 test, with IHC4 score a highly significant predictor of distant recurrence. This study included data from a UK setting and appeared to be of reasonable quality. Evidence for the remaining five tests (PAM50, NPI+, BCI, BluePrint and Randox) was limited. The economic analysis suggests that treatment guided using IHC4 has the greatest potential to be cost-effective at a £20,000 threshold, given the low cost of the test; however, further research is needed on the analytical validity and clinical utility of IHC4, and the exact cost of the test needs to be confirmed. Current limitations in the evidence base produce significant uncertainty in the results. OncotypeDX has a more robust evidence base, but further evidence on its impact on decision-making in the UK and the predictive ability of the test in an ER+, LN-, HER- population receiving current drug regimens is needed. For MammaPrint and Mammostrat there were significant gaps in the available evidence and the estimates of cost-effectiveness produced were not considered to be robust by the External Assessment Group. Methodological weaknesses in the clinical evidence base relate to heterogeneity of patient cohorts and issues arising from the retrospective nature of the evidence. Further evidence is required on the clinical utility of all of the tests and on UK-based populations. A key area of uncertainty relates to whether the tests provide prognostic or predictive ability. The clinical evidence base for OncotypeDX is considered to be the most robust. The economic analysis suggested that treatment guided using IHC4 has the most potential to be cost-effective at a threshold of £20,000; however, the evidence base to support IHC4 needs significant further research. PROSPERO 2011:CRD42011001361, available from www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42011001361.

Short-Term Memory and Auditory Processing Disorders: Concurrent Validity and Clinical Diagnostic Markers

ERIC Educational Resources Information Center

Maerlender, Arthur

2010-01-01

Auditory processing disorders (APDs) are of interest to educators and clinicians, as they impact school functioning. Little work has been completed to demonstrate how children with APDs perform on clinical tests. In a series of studies, standard clinical (psychometric) tests from the Wechsler Intelligence Scale for Children, Fourth Edition…

Development and Testing of the Collaboration in the Clinical Learning Environment (CCLE) Tool

ERIC Educational Resources Information Center

Hooven, Katie J.

2016-01-01

The purpose of this study was to develop and psychometrically test the Collaboration in the Clinical Learning Environment (CCLE) Tool. The researcher acknowledged two distinct populations that required input into this particular tool development: staff nurses who work on floors that are considered clinical learning environments for students, and…

Graded aerobic treadmill testing in pediatric sports-related concussion: safety, clinical use, and patient outcomes.

PubMed

Cordingley, Dean; Girardin, Richard; Reimer, Karen; Ritchie, Lesley; Leiter, Jeff; Russell, Kelly; Ellis, Michael J

2016-12-01

OBJECTIVE The objectives of this study were 2-fold: 1) to evaluate the safety, tolerability, and clinical use of graded aerobic treadmill testing in pediatric patients with sports-related concussion (SRC), and 2) to evaluate the clinical outcomes of treatment with a submaximal aerobic exercise program in patients with physiological post-concussion disorder (PCD). METHODS The authors conducted a retrospective chart review of pediatric patients (age < 20 years) with SRC who were referred to a multidisciplinary pediatric concussion program and underwent graded aerobic treadmill testing between October 9, 2014, and February 11, 2016. Clinical assessments were carried out by a single neurosurgeon and included clinical history taking, physical examination, and recording specific patient-reported concussion-related symptoms using the Post-Concussion Symptom Scale (PCSS). Graded aerobic treadmill testing using a modified Balke protocol for incremental increases in intensity was used as a diagnostic tool to assess physiological recovery, classify post-concussion syndrome (PCS) subtype, and reassess patients following treatment. Patients with a symptom-limited threshold on treadmill testing (physiological PCD) were treated with an individually tailored submaximal exercise prescription and multidisciplinary targeted therapies. RESULTS One hundred six patients (mean age 15.1 years, range 11-19 years) with SRC underwent a total of 141 treadmill tests. There were no serious complications related to treadmill testing in this study. Overall, 138 (97.9%) of 141 tests were well tolerated and contributed valuable clinical information. Treadmill testing confirmed physiological recovery in 63 (96.9%) of 65 patients tested, allowing successful return to play in 61 (93.8%). Treadmill testing was used to diagnose physiological PCD in 58 patients and cervicogenic PCD in 1 patient. Of the 41 patients with physiological PCD who had complete follow-up and were treated with tailored submaximal exercise prescription, 37 (90.2%) were classified as clinically improved and 33 (80.5%) successfully returned to sporting activities. Patients who did not respond or experienced an incomplete response to submaximal aerobic exercise treatment included 7 patients with migraine headaches and 1 patient with a postinjury psychiatric disorder. CONCLUSIONS Graded aerobic treadmill testing is a safe, tolerable, and clinically valuable tool that can assist in the evaluation and management of pediatric SRC. Future research is needed to confirm the clinical value of this tool in return-to-play decision making. Studies are also needed to understand the pathophysiology of physiological PCD and the effects of targeted treatment.

[Clinical competence evaluation using the Objective Structured Clinical Examination (OSCE) in medical internship at UNAM].

PubMed

Trejo Mejía, Juan Andrés; Martínez González, Adrián; Méndez Ramírez, Ignacio; Morales López, Sara; Ruiz Pérez, Leobardo C; Sánchez Mendiola, Melchor

2014-01-01

The Objective Structured Clinical Examination (OSCE) is a widely used measurement tool to assess clinical competence in the health sciences. There is little published evidence of its use in Mexican medical schools. To assess clinical competence in medical students with an OSCE, before and after the Medical Internship. Prospective cohort study, pre- post-test research design. The assessed population was medical students at UNAM Faculty of Medicine in Mexico in their Internship year. The instrument was an 18-stations OSCE, three stations per academic area of the Internship curriculum. We assessed the clinical competence of 278 students in a pretest OSCE when starting the Internship year, and tested them 10 months later with an equivalent post-test OSCE. The sample of students was 30.4% of the total Internship population. Test reliability with Cronbach's alpha was 0.62 in the pre-test and 0.64 in the post-test. The global mean score in the pretest OSCE was 55.6 ± 6.6 and in the post-test 63.2 ± 5.7 (p < 0.001), with a Cohen's d of 1.2. The clinical competence of medical students measured with an OSCE is higher after the medical internship year. This difference suggests that the internship can influence the development of clinical competence in medical students.

Obtaining patient test results from clinical laboratories: a survey of state law for pharmacists.

PubMed

Witry, Matthew J; Doucette, William R

2009-01-01

To identify states with laws that restrict to whom clinical laboratories may release copies of laboratory test results and to describe how these laws may affect pharmacists' ability to obtain patient laboratory test results. Researchers examined state statutes and administrative codes for all 50 states and the District of Columbia at the University of Iowa Law Library between June and July 2007. Researchers also consulted with lawyers, state Clinical Laboratory Improvement Amendments officers, and law librarians. Laws relating to the study objective were analyzed. 34 jurisdictions do not restrict the release of laboratory test results, while 17 states have laws that restrict to whom clinical laboratories can send copies of test results. In these states, pharmacists will have to use alternative sources, such as physician offices, to obtain test results. Pharmacists must consider state law before requesting copies of laboratory test results from clinical laboratories. This may be an issue that state pharmacy associations can address to increase pharmacist access to important patient information.

[NPT (near patient test) in the pharmacy: document and practice guidelines 2008].

PubMed

Stuard, S; Cesarone, M R; Belcaro, G; Ledda, A; Cornelli, U; Di Renzo, A; Grossi, M G; Pellegrini, L; Gizzi, G; Vinciguerra, G; Dugall, M; Corsi, M; Ippolito, E; Di Palma, T; Zulli, C; Del Boccio, G

2008-10-01

NPT tests in the pharmacy. Blood testing can be made with NPT (near patient testing) directly in the pharmacy. Most tests can be made with a single drop of blood (i.e. from a finger) and results are comparable with results from blood test obtained with standard vein blood samples. NPT is basically used for: 1 - evaluating the risk of a disease. 2 evaluating or confirming the presence of a disease. 3 to manage and monitor treatments. The social role of the pharmacy in NPT (particularly in cardiovascular screening) is very important as the pharmacy is an institution with capillary diffusion in the territory. The pharmacy often constitutes an important, first-level consultancy point for the population, particularly where health institutions are far away (small villages) or not easily accessible. Rules for NPT. Guidelines for NPT testing in the pharmacy have been proposed and discussed in a consensus meeting (Spoleto, 2007). NPT guidelines suggest operating management and technical procedures and indicate prospective lines of action defining new roles for the pharmacy. Coagulation tests can be now made in the pharmacy at a very low cost and with an efficacy comparable to blood tests obtained with a vein sample. Results can be read in seconds. This test is also available for personal use and home testing. NPT: The Clinical Study. The evaluation of the results of a clinical study (patients with venous thrombosis/pulmonary embolisation, patients with fibrillation and patients with artificial cardiac valves) indicates that costing is very favourable for NPT which may reduce costs and improve management of many clinical conditions and their monitoring. Training and control systems help NPT testing to be reliable and useful to screen and manage most clinical and risk conditions. The clinical study also shows the positive correlation between NPT tests and standard' tests. In conclusion NPT tests are now very reliable and cost-effective and can be used for screening, diagnosis and to monitor treatments.

Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

PubMed

Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

2017-11-01

Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

Reducing inpatient heritable thrombophilia testing using a clinical decision-making tool.

PubMed

Smith, Tyler W; Pi, David; Hudoba, Monika; Lee, Agnes Y Y

2014-04-01

To evaluate the impact of a clinical decision-making tool, designed to educate physicians regarding heritable thrombophilia (HT) testing, on the volume of testing in hospitalised patients in the tertiary care setting. We performed a retrospective cohort study over a 6-year period (2007-2012) at a single tertiary care centre intervention site and two regional control sites. In January 2010, the intervention site instituted a policy change whereby physicians ordering HT testing on inpatients needed to complete a pre-preprinted order (PPO) form that outlined the limitations of HT testing in the hospitalised setting. Failure to complete the PPO within 24 h resulted in test cancellation. Our main outcome measure was the volume of HT testing performed at the three study sites. Introduction of the PPO resulted in a 79.4% (95% CI 71.2% to 87.6%) reduction in factor V Leiden (FVL) testing at the intervention site. This decrease was significantly greater compared with those in the two control teaching hospitals over the same time periods (33.7% and 43.6%; both p<0.001). Reductions in FVL testing postintervention were observed among all ordering specialists. Similar postintervention reductions in testing volumes were observed for antithrombin (57.4%), protein C (61.9%) and protein S (62.2%) activity assays. In a large tertiary care hospital, the introduction of a clinical decision-making tool significantly reduced HT testing in inpatients across clinical specialties. The impact on patient outcome should be assessed in further studies.

Frequency and determinants of consistent STI/HIV testing among men who have sex with men testing at STI outpatient clinics in the Netherlands: a longitudinal study.

PubMed

Visser, Maartje; Heijne, Janneke C M; Hogewoning, Arjan A; van Aar, Fleur

2017-09-01

Men who have sex with men (MSM) are at highest risk for STIs and HIV infections in the Netherlands. However, official guidelines on STI testing among MSM are lacking. They are advised to test for STIs at least every six months, but their testing behaviour is not well known. This study aimed to get insight into the proportion and determinants of consistent 6-monthly STI testing among MSM testing at STI outpatient clinics in the Netherlands. This study included longitudinal surveillance data of STI consultations among MSM from all 26 STI outpatient clinics in the Netherlands between 1 June 2014 and 31 December 2015. Multinomial logistic regression analysis was used to identify determinants of consistent 6-monthly testing compared with single testing and inconsistent testing. Determinants of time between consultations among men with multiple consultations were analysed using a Cox Prentice-Williams-Peterson gap-time model. A total of 34 605 STI consultations of 18 634 MSM were included. 8966 (48.1%) men had more than one consultation, and 3516 (18.9%) men tested consistently 6-monthly. Indicators of high sexual risk behaviour, including having a history of STI, being HIV positive and having more than 10 sex partners, were positively associated with both being a consistent tester and returning to the STI clinic sooner. Men who were notified by a partner or who reported STI symptoms were also more likely to return to the STI clinic sooner, but were less likely to be consistent testers, identifying a group of event-driven testers. The proportion of consistent 6-monthly testers among MSM visiting Dutch STI outpatient clinics was low. Testing behaviour was associated with sexual risk behaviour, but exact motives to test consistently remain unclear. Evidence-based testing guidelines are needed to achieve optimal reductions in STI transmission in the future. 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/.

Experience using the «Shetty test» for initial foot and ankle fracture screening in the Emergency Department.

PubMed

Ojeda-Jiménez, J; Méndez-Ojeda, M M; Martín-Vélez, P; Tejero-García, S; Pais-Brito, J L; Herrera-Pérez, M

2018-03-20

The indiscriminate practice of radiographs for foot and ankle injuries is not justified and numerous studies have corroborated the usefulness of clinical screening tests such as the Ottawa Ankle Rules. The aim of our study is to clinically validate the so-called Shetty Test in our area. A cross-sectional observational study by applying the Shetty test to patients seen in the Emergency Department. We enrolled 100 patients with an average age of 39.25 (16-86). The Shetty test was positive on 14 occasions. Subsequent radiography revealed a fracture in 10 cases: 4 were false positives. The test was negative in the remaining 86 patients and radiography confirmed the absence of fracture (with sensitivity of 100% and specificity of 95.56%, positive predictive value of 71.40%, and negative predictive value of 100%). The Shetty test is a valid clinical screening tool to decide whether simple radiography is indicated for foot and ankle injuries. It is a simple, quick and reproducible test. Copyright © 2018 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Use of Subjective Global Assessment, Patient-Generated Subjective Global Assessment and Nutritional Risk Screening 2002 to evaluate the nutritional status of non-critically ill patients on parenteral nutrition.

PubMed

Badia-Tahull, M B; Cobo-Sacristán, S; Leiva-Badosa, E; Miquel-Zurita, M E; Méndez-Cabalerio, N; Jódar-Masanés, R; Llop-Talaverón, J

2014-02-01

To evaluate the nutritional status of non-critically ill digestive surgery patients at the moment of parenteral nutrition initiation using three different nutritional test tools and to study their correlation. To study the association between the tests and the clinical and laboratory parameters used in the follow-up of PN treatment. Prospective study over 4 months. Anthropometric and clinical variables were recorded. Results of Subjective Global Assessment; Patient-Generated Subjective Global Assessment; and Nutritional Risk Screening 2002 were compared applying kappa test. Relationship between the clinical and laboratory parameters with Subjective Global Assessment was studied by multinominal regression and with the other two tests by multiple linear regression models. Age and sex were included as adjustment variables. Malnutrition in 45 studied patients varied from 51% to 57%. Subjective Global Assessment correlated well with Patient-Generated Subjective Global Assessment and Nutritional Risk Screening 2002 (κ = 0531 p = 0.000). The test with the greatest correlation with the clinical and analytical variables was the Nutritional Risk Screening 2002. Worse nutritional state in this test was associated with worse results in albumin (B = -0.087; CI = -0.169/-0.005], prealbumin (B = -0.005; CI = [-0.011/-0.001]), C-reactive protein (B = 0.006;CI = [0.001/ 0.011]) and leukocytes (B = 0.134; CI = [0.031/0.237]) at the en of parenteral nutrition treatment. Half of the digestive surgery patients were at malnutritional risk at the moment of initiating parenteral nutrition. Nutritional Risk Screening 2002 was the test with best association with the parameters used in the clinical follow-up of parenteral nutrition treated patients. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Stakeholder Assessment of the Evidence for Cancer Genomic Tests: Insights from Three Case Studies

PubMed Central

Deverka, Patricia A.; Schully, Sheri D.; Ishibe, Naoko; Carlson, Josh J.; Freedman, Andrew; Goddard, Katrina A.B.; Khoury, Muin J.; Ramsey, Scott D.

2015-01-01

Insufficient evidence on the net benefits and harms of genomic tests in real-world settings is a translational barrier for genomic medicine. Purpose Understanding stakeholders’ assessment of the current evidence base for clinical practice and coverage decisions should be a critical step to influence research, policy, and practice. Methods Twenty-two stakeholders participated in a workshop exploring the evidence of genomic tests for clinical and coverage decision-making. Stakeholders completed a survey prior to and during the meeting. They also discussed if they would recommend for or against current clinical use of each test. Results At baseline, the level of confidence on the clinical validity and clinical utility of each test varied, although the group expressed greater confidence for EGFR mutation and Lynch Syndrome (LS) testing than for Oncotype DX. Following the discussion, survey results reflected even less confidence for Oncotype DX and EGFR testing, but not LS. The majority of stakeholders would consider clinical use for all three tests, but under the conditions of additional research or a shared clinical decision-making approach. Conclusion Stakeholder engagement in unbiased settings is necessary to understand various perspectives about evidentiary thresholds in genomic medicine. Participants recommended the use of various methods for evidence generation and synthesis. PMID:22481130

Objective assessment of attention in delirium: a narrative review.

PubMed

Tieges, Zoë; Brown, Laura J E; MacLullich, Alasdair M J

2014-12-01

Inattention is a core feature of delirium, and valid assessment of attention is central to diagnosis. Methods of measuring attention in delirium can be divided into two broad categories: (i) objective neuropsychological testing; and (ii) subjective grading of behaviour during interview and clinical examination. Here, we review and critically evaluate studies of objective neuropsychological testing of attention in delirium. We examine the implications of these studies for delirium detection and monitoring in clinical practice and research, and how these studies inform understanding of the nature of attentional deficits in delirium. Searches of MEDLINE and ISI Web of Knowledge databases were performed to identify studies in which objective tests of attention had been administered to patients with delirium, who had been diagnosed using DSM or ICD criteria. Sixteen publications were identified. The attention tests administered in these studies were grouped into the following categories: measures of attention span, vigilance tests, other pen-and-paper tests (e.g. Trail Making Test) and computerised tests of speeded reaction, vigilance and sustained attention. Patients with delirium showed deficits on all tasks, although most tasks were not considered pure measures of attention. Five papers provided data on differential diagnosis from dementia. Cancellation tests, spatial span tests and computerised tests of sustained attention discriminated delirium from dementia. Five studies presented reliability or validity statistics. The existing evidence base on objective assessment of attention in delirium is small. Objective testing of attention is underdeveloped but shows considerable promise in clinical practice and research. Copyright © 2014 John Wiley & Sons, Ltd.

Analytical validation of a novel multiplex test for detection of advanced adenoma and colorectal cancer in symptomatic patients.

PubMed

Dillon, Roslyn; Croner, Lisa J; Bucci, John; Kairs, Stefanie N; You, Jia; Beasley, Sharon; Blimline, Mark; Carino, Rochele B; Chan, Vicky C; Cuevas, Danissa; Diggs, Jeff; Jennings, Megan; Levy, Jacob; Mina, Ginger; Yee, Alvin; Wilcox, Bruce

2018-05-30

Early detection of colorectal cancer (CRC) is key to reducing associated mortality. Despite the importance of early detection, approximately 40% of individuals in the United States between the ages of 50-75 have never been screened for CRC. The low compliance with colonoscopy and fecal-based screening may be addressed with a non-invasive alternative such as a blood-based test. We describe here the analytical validation of a multiplexed blood-based assay that measures the plasma concentrations of 15 proteins to assess advanced adenoma (AA) and CRC risk in symptomatic patients. The test was developed on an electrochemiluminescent immunoassay platform employing four multi-marker panels, to be implemented in the clinic as a laboratory developed test (LDT). Under the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) regulations, a United States-based clinical laboratory utilizing an LDT must establish performance characteristics relating to analytical validity prior to releasing patient test results. This report describes a series of studies demonstrating the precision, accuracy, analytical sensitivity, and analytical specificity for each of the 15 assays, as required by CLIA/CAP. In addition, the report describes studies characterizing each of the assays' dynamic range, parallelism, tolerance to common interfering substances, spike recovery, and stability to sample freeze-thaw cycles. Upon completion of the analytical characterization, a clinical accuracy study was performed to evaluate concordance of AA and CRC classifier model calls using the analytical method intended for use in the clinic. Of 434 symptomatic patient samples tested, the percent agreement with original CRC and AA calls was 87% and 92% respectively. All studies followed CLSI guidelines and met the regulatory requirements for implementation of a new LDT. The results provide the analytical evidence to support the implementation of the novel multi-marker test as a clinical test for evaluating CRC and AA risk in symptomatic individuals. Copyright © 2018 Elsevier B.V. All rights reserved.

Adherence to Standards for Reporting Diagnostic Accuracy in Emergency Medicine Research.

PubMed

Gallo, Lucas; Hua, Nadia; Mercuri, Mathew; Silveira, Angela; Worster, Andrew

2017-08-01

Diagnostic tests are used frequently in the emergency department (ED) to guide clinical decision making and, hence, influence clinical outcomes. The Standards for Reporting of Diagnostic Accuracy (STARD) criteria were developed to ensure that diagnostic test studies are performed and reported to best inform clinical decision making in the ED. The objective was to determine the extent to which diagnostic studies published in emergency medicine journals adhered to STARD 2003 criteria. Diagnostic studies published in eight MEDLINE-listed, peer-reviewed, emergency medicine journals over a 5-year period were reviewed for compliance to STARD criteria. A total of 12,649 articles were screened and 114 studies were included in our study. Twenty percent of these were randomly selected for assessment using STARD 2003 criteria. Adherence to STARD 2003 reporting standards for each criteria ranged from 8.7% adherence (criteria-reporting adverse events from performing index test or reference standard) to 100% (multiple criteria). Just over half of STARD criteria are reported in more than 80% studies. As poorly reported studies may negatively impact their clinical usefulness, it is essential that studies of diagnostic test accuracy be performed and reported adequately. Future studies should assess whether studies have improved compliance with the STARD 2015 criteria amendment. © 2017 by the Society for Academic Emergency Medicine.

Characteristics of clients who access mobile compared to clinic HIV counselling and testing services: a matched study from Cape Town, South Africa.

PubMed

Meehan, Sue-Ann; Naidoo, Pren; Claassens, Mareli M; Lombard, Carl; Beyers, Nulda

2014-12-20

Studies within sub-Saharan African countries have shown that mobile services increase uptake of HIV counselling and testing (HCT) services when compared to clinics and are able to access different populations, but these have included provider-initiated HCT in clinics. This study aimed to compare the characteristics of clients who self-initiated HCT at either a mobile or a clinic service in terms of demographic and socio-economic variables, also comparing reasons for accessing a particular health service provider. This study took place in eight areas around Cape Town. A matched design was used with one mobile HCT service matched with one or more clinics (offering routine HCT services) within each of the eight areas. Adult clients who self-referred for an HIV test within a specified time period at either a mobile or clinic service were invited to participate in the study. Data were collected between February and April 2011 using a questionnaire. Summary statistics were calculated for each service type within a matched pair and differences of outcomes from pairs were used to calculate effect sizes and 95% confidence intervals. 1063 participants enrolled in the study with 511 from mobile and 552 from clinic HCT services. The proportion of males accessing mobile HCT significantly exceeded that of clinic HCT (p < 0.001). The mean age of participants attending mobile HCT was higher than clinic participants (p = 0.023). No significant difference was found for socio-economic variables between participants, with the exception of access to own piped water (p = 0.029). Participants who accessed mobile HCT were significantly more likely to report that they were just passing, deemed an "opportunistic" visit (p = 0.014). Participants who accessed clinics were significantly more likely to report the service being close to home or work (p = 0.035). An HCT strategy incorporating a mobile HCT service, has a definite role to play in reaching those population groups who do not typically access HCT services at a clinic, especially males and those who take advantage of the opportunity to test. Mobile HCT services can complement clinic services.

Correlates of having never been HIV tested among entrants to substance abuse treatment clinics: empiric findings from real-world New England settings.

PubMed

Chadwick, Jeanne J; Andrade, Leonardo F; Altice, Frederick L; Petry, Nancy M

2014-01-01

Routine testing is the cornerstone to identifying HIV, but not all substance abuse treatment patients have been tested. This study is a real-world evaluation of predictors of having never been HIV tested among patients initiating substance abuse treatment. Participants (N = 614) from six New England clinics were asked whether they had ever been HIV tested. Eighty-five patients (13.8%) reported having never been tested and were compared to those who had undergone testing. Clinic, male gender (adjusted odds ratio (AOR) = 1.91, 95% confidence interval (CI) = 1.07-3.41), and having fewer employment (AOR = 0.31; 95% CI = 0.11-0.88) and medical problems (AOR = 0.40, 95% CI = 0.17-0.99) were independently correlated with having never been HIV tested. Thus, there is still considerable room for improved testing strategies as a clinically significant minority of substance abuse patients have never undergone HIV testing when they initiate treatment.

Retesting for genital Chlamydia trachomatis among visitors of a sexually transmitted infections clinic: randomized intervention trial of home- versus clinic-based recall.

PubMed

Götz, Hannelore M; Wolfers, Mireille E G; Luijendijk, Ad; van den Broek, Ingrid V F

2013-05-24

Reinfections of Chlamydia trachomatis (Ct) are common. In a two-armed intervention study at an urban STI clinic in the Netherlands, heterosexual Ct-positive visitors received an invitation for retesting after 4-5 months. Interventions were either home-based sampling by mailed test-kit, or clinic-based testing without appointment. Data collection included socio-demographic and sexual behavioural variables at first (T0) and repeat test (T1). Participation in retesting, prevalence and determinants of repeat infection among study participants are described and compared with findings from non-participants. Of the 216 visitors enrolled in the study, 75 accepted retesting (35%). The retest participation was 46% (50/109) in the home group versus 23% (25/107) in the clinic group (p = 0.001). Men were less often retested than women (15% versus 43%, p < 0.001). The overall chlamydia positivity rate at retest was 17.3% (13/75) compared to 12.4% seen at all visits at the STI clinic in 2011. Repeated infections were more frequent among non-Dutch than Dutch participants (27.0% versus 7.9%; p = 0.04) and in persons reporting symptoms (31.0% versus 7.0%; p = 0.01). Both untreated infections of current partners as well as unprotected sex with new partners contribute to repeated infections. The high rate of repeated infections indicates the need for interventions to increase retesting; improvement of partner-management and risk reduction counselling remain necessary. Home- based testing was more effective than clinic-based testing. However other strategies, including self-triage of patients, may also increase repeat testing rates and personal preferences should be taken into account.

Evaluating students' perception of their clinical placements - testing the clinical learning environment and supervision and nurse teacher scale (CLES + T scale) in Germany.

PubMed

Bergjan, Manuela; Hertel, Frank

2013-11-01

Clinical nursing education in Germany has not received attention in nursing science and practice for a long time, as it often seems to be a more or less "formalized appendix" of nursing education. Several development projects of clinical education taking place are mainly focused on the qualification of clinical preceptors. However, the clinical context and its influence on learning processes have still not been sufficiently investigated. The aim of this study was the testing of a German version of the clinical learning environment and supervision and nurse teacher scale (CLES + T scale). The sample of the pilot study consists of first-, second- and third-year student nurses (n=240) of a university nursing school from January to March 2011. Psychometric testing of the instrument is carried out by selected methods of classical testing theories using SPPS 19. The results show transferability of all subcategories of the CLES + T scale in the non-academic nursing education system of a university hospital in Germany, without the teacher scale. The strongest factor is "supervisory relationship". The German version of the CLES + T scale may help to evaluate and compare traditional and new models in clinical nursing education. Copyright © 2012 Elsevier Ltd. All rights reserved.

Efficient strategies to find diagnostic test accuracy studies in kidney journals.

PubMed

Rogerson, Thomas E; Ladhani, Maleeka; Mitchell, Ruth; Craig, Jonathan C; Webster, Angela C

2015-08-01

Nephrologists looking for quick answers to diagnostic clinical questions in MEDLINE can use a range of published search strategies or Clinical Query limits to improve the precision of their searches. We aimed to evaluate existing search strategies for finding diagnostic test accuracy studies in nephrology journals. We assessed the accuracy of 14 search strategies for retrieving diagnostic test accuracy studies from three nephrology journals indexed in MEDLINE. Two investigators hand searched the same journals to create a reference set of diagnostic test accuracy studies to compare search strategy results against. We identified 103 diagnostic test accuracy studies, accounting for 2.1% of all studies published. The most specific search strategy was the Narrow Clinical Queries limit (sensitivity: 0.20, 95% CI 0.13-0.29; specificity: 0.99, 95% CI 0.99-0.99). Using the Narrow Clinical Queries limit, a searcher would need to screen three (95% CI 2-6) articles to find one diagnostic study. The most sensitive search strategy was van der Weijden 1999 Extended (sensitivity: 0.95; 95% CI 0.89-0.98; specificity 0.55, 95% CI 0.53-0.56) but required a searcher to screen 24 (95% CI 23-26) articles to find one diagnostic study. Bachmann 2002 was the best balanced search strategy, which was sensitive (0.88, 95% CI 0.81-0.94), but also specific (0.74, 95% CI 0.73-0.75), with a number needed to screen of 15 (95% CI 14-17). Diagnostic studies are infrequently published in nephrology journals. The addition of a strategy for diagnostic studies to a subject search strategy in MEDLINE may reduce the records needed to screen while preserving adequate search sensitivity for routine clinical use. © 2015 Asian Pacific Society of Nephrology.

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

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

2014-12-01

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. 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. 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. NCT02209116. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

A study to derive a clinical decision rule for triage of emergency department patients with chest pain: design and methodology

PubMed Central

Hess, Erik P; Wells, George A; Jaffe, Allan; Stiell, Ian G

2008-01-01

Background Chest pain is the second most common chief complaint in North American emergency departments. Data from the U.S. suggest that 2.1% of patients with acute myocardial infarction and 2.3% of patients with unstable angina are misdiagnosed, with slightly higher rates reported in a recent Canadian study (4.6% and 6.4%, respectively). Information obtained from the history, 12-lead ECG, and a single set of cardiac enzymes is unable to identify patients who are safe for early discharge with sufficient sensitivity. The 2007 ACC/AHA guidelines for UA/NSTEMI do not identify patients at low risk for adverse cardiac events who can be safely discharged without provocative testing. As a result large numbers of low risk patients are triaged to chest pain observation units and undergo provocative testing, at significant cost to the healthcare system. Clinical decision rules use clinical findings (history, physical exam, test results) to suggest a diagnostic or therapeutic course of action. Currently no methodologically robust clinical decision rule identifies patients safe for early discharge. Methods/design The goal of this study is to derive a clinical decision rule which will allow emergency physicians to accurately identify patients with chest pain who are safe for early discharge. The study will utilize a prospective cohort design. Standardized clinical variables will be collected on all patients at least 25 years of age complaining of chest pain prior to provocative testing. Variables strongly associated with the composite outcome acute myocardial infarction, revascularization, or death will be further analyzed with multivariable analysis to derive the clinical rule. Specific aims are to: i) apply standardized clinical assessments to patients with chest pain, incorporating results of early cardiac testing; ii) determine the inter-observer reliability of the clinical information; iii) determine the statistical association between the clinical findings and the composite outcome; and iv) use multivariable analysis to derive a highly sensitive clinical decision rule to guide triage decisions. Discussion The study will derive a highly sensitive clinical decision rule to identify low risk patients safe for early discharge. This will improve patient care, lower healthcare costs, and enhance flow in our busy and overcrowded emergency departments. PMID:18254973

An assessment of the utilization of the preclinical rodent model literature in clinical trials of putative therapeutics for the treatment of alcohol use disorders.

PubMed

Barajaz, Ashley M; Kliethermes, Christopher L

2017-12-01

Rodent models of Alcohol Use Disorders (AUD) are used extensively by preclinical researchers to develop new therapeutics for the treatment of AUD. Although these models play an important role in the development of novel, targeted therapeutics, their role in bringing therapeutics to clinical trials is unclear, as off-label use of existing medications not approved for the treatment of AUD is commonly seen in the clinic and clinical trials. In the current study, we used the Clinicaltrials.gov database to obtain a list of drugs that have been tested for efficacy in a clinical trial between 1997 and 2017. We then conducted a set of literature searches to determine which of the 98 unique drugs we identified had shown efficacy in a rodent model of an AUD prior to being tested in a clinical trial. We found that slightly less than half of the drugs tested in clinical trials (48%) had shown prior efficacy in any rodent model of an AUD, while the remaining 52% of drugs were used off-label, or in some cases, following non-published studies. This study raises the question of how clinical researchers incorporate results from preclinical studies in the decision to bring a drug to a clinical trial. Our results underscore the need for ongoing communication among preclinical and clinical researchers. Copyright © 2017 Elsevier B.V. All rights reserved.

Projective Techniques: An International Perspective.

ERIC Educational Resources Information Center

Piotrowski, Chris; And Others

The findings of the following four recent surveys on clinical test use in the United States, the Netherlands, Japan, and Hong Kong are reviewed: (1) "Clinical Psychological Test Usage in Japan: A Comparative Study with a Survey in the U.S.A." (T. Ogawa and C. Piotrowski, 1992); (2) "Patterns of Psychological Test Use in Hong…

Reliability of clinical diagnosis and laboratory testing techniques currently used for identification of canine parvovirus enteritis in clinical settings

PubMed Central

FAZ, Mirna; MARTÍNEZ, José Simón; QUIJANO-HERNÁNDEZ, Israel; FAJARDO, Raúl

2016-01-01

Canine parvovirus type 2 (CPV-2) is the main etiological agent of viral enteritis in dogs. Actually in literature, CPV-2 has been reported with clinical signs that vary from the classical disease, and immunochromatography test and PCR technique have been introduced to veterinary hospitals to confirm CPV-2 diagnosis and other infections. However, the reliability of these techniques has been poorly analyzed. In this study, we evaluated the sensitivity and specificity of veterinary clinical diagnosis, immunochromatography test and PCR technique. Our data indicate that variations in the clinical signs of CPV-2 complicate the gathering of an appropriate diagnosis; and immunochromatography test and PCR technique do not have adequate sensitivity to diagnose positive cases. PMID:27818461

Development and Validation of Targeted Next-Generation Sequencing Panels for Detection of Germline Variants in Inherited Diseases.

PubMed

Santani, Avni; Murrell, Jill; Funke, Birgit; Yu, Zhenming; Hegde, Madhuri; Mao, Rong; Ferreira-Gonzalez, Andrea; Voelkerding, Karl V; Weck, Karen E

2017-06-01

- The number of targeted next-generation sequencing (NGS) panels for genetic diseases offered by clinical laboratories is rapidly increasing. Before an NGS-based test is implemented in a clinical laboratory, appropriate validation studies are needed to determine the performance characteristics of the test. - To provide examples of assay design and validation of targeted NGS gene panels for the detection of germline variants associated with inherited disorders. - The approaches used by 2 clinical laboratories for the development and validation of targeted NGS gene panels are described. Important design and validation considerations are examined. - Clinical laboratories must validate performance specifications of each test prior to implementation. Test design specifications and validation data are provided, outlining important steps in validation of targeted NGS panels by clinical diagnostic laboratories.

Computerized neurocognitive testing in the management of sport-related concussion: an update.

PubMed

Resch, Jacob E; McCrea, Michael A; Cullum, C Munro

2013-12-01

Since the late nineties, computerized neurocognitive testing has become a central component of sport-related concussion (SRC) management at all levels of sport. In 2005, a review of the available evidence on the psychometric properties of four computerized neuropsychological test batteries concluded that the tests did not possess the necessary criteria to warrant clinical application. Since the publication of that review, several more computerized neurocognitive tests have entered the market place. The purpose of this review is to summarize the body of published studies on psychometric properties and clinical utility of computerized neurocognitive tests available for use in the assessment of SRC. A review of the literature from 2005 to 2013 was conducted to gather evidence of test-retest reliability and clinical validity of these instruments. Reviewed articles included both prospective and retrospective studies of primarily sport-based adult and pediatric samples. Summaries are provided regarding the available evidence of reliability and validity for the most commonly used computerized neurocognitive tests in sports settings.

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

Self-Testing of Vision in Age-Related Macula Degeneration: A Longitudinal Pilot Study Using a Smartphone-Based Rarebit Test

PubMed Central

2015-01-01

Purpose. There is a need for efficient self-tests of vision in patients with neovascular age-related macula degeneration. A new tablet/smartphone application aiming to meet this need is described and its performance is assessed in a longitudinal pilot study. Materials and Methods. The new MultiBit Test (MBT) employs segmented digits defined by rarebits, that is, receptive field-size bright dots briefly presented against a dark background. The number of rarebits per digit segment was varied in a cyclic fashion, in preset steps. There were no fixation demands. Twenty-eight patients with neovascular AMD of varying severity were monitored for an average of 30 weeks. Test scores were evaluated on an individual basis, by contrasting observed trends with the clinical status recorded at independently scheduled clinical examinations. Results. Serial plots of MBT results revealed gradual improvement after successful antineovascular treatment. Recurrences were signalled by gradual deteriorations of results. Test results remained stable during clinically stable time intervals. MBT results agreed well with clinical assessments whereas an acuity test performed at chance level. The MBT was well accepted by all subjects. Conclusions. The MBT appears to have a good potential for effective self-testing of vision in AMD and merits large-scale studies. Exploration of MBT performance with other forms of macula conditions may be worthwhile. PMID:26124958

Investigation of potential cognitive tests for use with older adults in audiology clinics.

PubMed

Vaughan, Nancy; Storzbach, Daniel; Furukawa, Izumi

2008-01-01

Cognitive declines in working memory and processing speed are hallmarks of aging. Deficits in speech understanding also are seen in aging individuals. A clinical test to determine whether the cognitive aging changes contribute to aging speech understanding difficulties would be helpful for determining rehabilitation strategies in audiology clinics. To identify a clinical neurocognitive test or battery of tests that could be used in audiology clinics to help explain deficits in speech recognition in some older listeners. A correlational study examining the association between certain cognitive test scores and speech recognition performance. Speeded (time-compressed) speech was used to increase the cognitive processing load. Two hundred twenty-five adults aged 50 through 75 years were participants in this study. Both batteries of tests were administered to all participants in two separate sessions. A selected battery of neurocognitive tests and a time-compressed speech recognition test battery using various rates of speech were administered. Principal component analysis was used to extract the important component factors from each set of tests, and regression models were constructed to examine the association between tests and to identify the neurocognitive test most strongly associated with speech recognition performance. A sequencing working memory test (Letter-Number Sequencing [LNS]) was most strongly associated with rapid speech understanding. The association between the LNS test results and the compressed sentence recognition scores (CSRS) was strong even when age and hearing loss were controlled. The LNS is a sequencing test that provides information about temporal processing at the cognitive level and may prove useful in diagnosis of speech understanding problems, and in the development of aural rehabilitation and training strategies.

Accuracy of clinical neurological examination in diagnosing lumbo-sacral radiculopathy: a systematic literature review.

PubMed

Tawa, Nassib; Rhoda, Anthea; Diener, Ina

2017-02-23

Lumbar radiculopathy remains a clinical challenge among primary care clinicians in both assessment and diagnosis. This often leads to misdiagnosis and inappropriate treatment of patients resulting in poor health outcomes, exacerbating this already debilitating condition. This review evaluated 12 primary diagnostic accuracy studies that specifically assessed the performance of various individual and grouped clinical neurological tests in detecting nerve root impingement, as established in the current literature. Eight electronic data bases were searched for relevant articles from inception until July 2016. All primary diagnostic studies which investigated the accuracy of clinical neurological test (s) in diagnosing lumbar radiculopathy among patients with low back and referred leg symptoms were screened for inclusion. Qualifying studies were retrieved and independently assessed for methodological quality using the 'Quality Assessment of Diagnostic tests Accuracy Studies' criteria. A total of 12 studies which investigated standard components of clinical neurological examination of (sensory, motor, tendon reflex and neuro-dynamics) of the lumbo-sacral spine were included. The mean inter-observer agreement on quality assessment by two independent reviewers was fair (k = 0.3 - 0.7). The diagnostic performance of sensory testing using MR imaging as a reference standard demonstrated a sensitivity (confidence interval 95%) 0.61 (0.47-0.73) and a specificity of 0.63 (0.38-0.84). Motor tests sensitivity was poor to moderate, ranging from 0.13 (0.04-0.31) to 0.61 (0.36-0.83). Generally, the diagnostic performance of reflex testing was notably good with specificity ranging from (confidence interval 95%) 0.60 (0.51-0.69) to 0.93 (0.87-0.97) and sensitivity ranging from 0.14 (0.09-0.21) to 0.67 (0.21-0.94). Femoral nerve stretch test had a high sensitivity of (confidence interval 95%) 1.00 (0.40-1.00) and specificity of 0.83 (0.52-0.98) while SLR test recorded a mean sensitivity of 0.84 (0.72-0.92) and specificity of 0.78 (0.67-0.87). There is a scarcity of studies on the diagnostic accuracy of clinical neurological examination testing. Furthermore there seem to be a disconnect among researchers regarding the diagnostic utility of lower limb neuro-dynamic tests which include the Straight Leg Raise and Femoral Nerve tests for sciatic and femoral nerve respectively. Whether these tests are able to detect the presence of disc herniation and subsequent nerve root compression or hyper-sensitivity of the sacral and femoral plexus due to mechanical irritation still remains debatable.

Indications for laboratory tests in primary care: assessment of the most frequent indications and requests with blank clinical information

PubMed Central

Salinas, Maria; López-Garrigós, Maite; Flores, Emilio; Leiva-Salinas, Maria; Esteban, Patricia; Ahumada, Miguel; Leiva-Salinas, Carlos

2016-01-01

Introduction The aim of this work is twofold. Firstly, to study the temporal evolution in the number of laboratory requests from primary care without clinical indication, and to analyse the number of such requests before and after the implementation of an automated requesting procedure. Secondly, to investigate what are the most frequent clinical indications that prompted laboratory testing. Materials and methods This is a retrospective observational study conducted from January 2009 to December 2015. We counted the requests without clinical question, calculated the number of such requests per total number of requests and listed the most frequent indications. Results The number of tests requests with a blank clinical indication was significantly higher in 2009 when compared to 2015 (80% vs. 20%; P < 0.001). For every year in this 7-year period, dyslipidemia, essential hypertension and diabetes were the most prevalent diagnoses that prompted a laboratory test in primary care, accounting for more than 20% of all indications. Conclusions The number of primary care requests without patient clinical question has decreased after the implementation of an automated requesting procedure. Disorders of lipid metabolism, essential hypertension and diabetes mellitus were the most prevalent diagnoses that prompted a laboratory test in primary care. PMID:27812310

Instrumented Static and Dynamic Balance Assessment after Stroke Using Wii Balance Boards: Reliability and Association with Clinical Tests

PubMed Central

Bower, Kelly J.; McGinley, Jennifer L.; Miller, Kimberly J.; Clark, Ross A.

2014-01-01

Background and Objectives The Wii Balance Board (WBB) is a globally accessible device that shows promise as a clinically useful balance assessment tool. Although the WBB has been found to be comparable to a laboratory-grade force platform for obtaining centre of pressure data, it has not been comprehensively studied in clinical populations. The aim of this study was to investigate the measurement properties of tests utilising the WBB in people after stroke. Methods Thirty individuals who were more than three months post-stroke and able to stand unsupported were recruited from a single outpatient rehabilitation facility. Participants performed standardised assessments incorporating the WBB and customised software (static stance with eyes open and closed, static weight-bearing asymmetry, dynamic mediolateral weight shifting and dynamic sit-to-stand) in addition to commonly employed clinical tests (10 Metre Walk Test, Timed Up and Go, Step Test and Functional Reach) on two testing occasions one week apart. Test-retest reliability and construct validity of the WBB tests were investigated. Results All WBB-based outcomes were found to be highly reliable between testing occasions (ICC  = 0.82 to 0.98). Correlations were poor to moderate between WBB variables and clinical tests, with the strongest associations observed between task-related activities, such as WBB mediolateral weight shifting and the Step Test. Conclusions The WBB, used with customised software, is a reliable and potentially useful tool for the assessment of balance and weight-bearing asymmetry following stroke. Future research is recommended to further investigate validity and responsiveness. PMID:25541939

Instrumented static and dynamic balance assessment after stroke using Wii Balance Boards: reliability and association with clinical tests.

PubMed

Bower, Kelly J; McGinley, Jennifer L; Miller, Kimberly J; Clark, Ross A

2014-01-01

The Wii Balance Board (WBB) is a globally accessible device that shows promise as a clinically useful balance assessment tool. Although the WBB has been found to be comparable to a laboratory-grade force platform for obtaining centre of pressure data, it has not been comprehensively studied in clinical populations. The aim of this study was to investigate the measurement properties of tests utilising the WBB in people after stroke. Thirty individuals who were more than three months post-stroke and able to stand unsupported were recruited from a single outpatient rehabilitation facility. Participants performed standardised assessments incorporating the WBB and customised software (static stance with eyes open and closed, static weight-bearing asymmetry, dynamic mediolateral weight shifting and dynamic sit-to-stand) in addition to commonly employed clinical tests (10 Metre Walk Test, Timed Up and Go, Step Test and Functional Reach) on two testing occasions one week apart. Test-retest reliability and construct validity of the WBB tests were investigated. All WBB-based outcomes were found to be highly reliable between testing occasions (ICC  = 0.82 to 0.98). Correlations were poor to moderate between WBB variables and clinical tests, with the strongest associations observed between task-related activities, such as WBB mediolateral weight shifting and the Step Test. The WBB, used with customised software, is a reliable and potentially useful tool for the assessment of balance and weight-bearing asymmetry following stroke. Future research is recommended to further investigate validity and responsiveness.

Bridging barriers to clinic-based HIV testing with new technology: translating self-implemented testing for African American youth.

PubMed

Catania, J A; Dolcini, M M; Harper, G W; Dowhower, D P; Dolcini-Catania, L G; Towner, S L; Timmons, A; Motley, D N; Tyler, D H

2015-12-01

Numerous barriers to clinic-based HIV testing exist (e.g., stigmatization) for African American youth. These barriers may be addressed by new technology, specifically HIV self-implemented testing (SIT). We conducted a series of formative phase 3 translation studies (49 face-to-face interviews, 9 focus groups, 1 advisory panel review) among low-income African American youth (15-19 years) and providers of adolescent services in two US cities to identify potential translation difficulties of the OraQuick SIT. Based on content analysis, we found that providers and African American youth viewed SITs positively compared to clinic-based testing. Data suggest that SITs may reduce social stigma and privacy concerns and increase convenience and normalization of HIV testing. Challenges with SIT implementation include difficulties accessing confirmatory testing, coping with adverse outcomes, and instructional materials that may be inappropriate for low socioeconomic status (SES) persons. Study results underscore the need for translation studies to identify specific comprehension and implementation problems African American youth may have with oral SITs.

Clinical Utility of Epstein-Barr Virus DNA Testing in the Treatment of Nasopharyngeal Carcinoma Patients.

PubMed

Kim, Kelly Y; Le, Quynh-Thu; Yom, Sue S; Ng, Raymond H W; Chan, K C Allen; Bratman, Scott V; Welch, John J; Divi, Rao L; Petryshyn, Raymond A; Conley, Barbara A

2017-08-01

Epstein-Barr virus (EBV) DNA analysis has been shown to be useful for early detection, prognostication, and monitoring of treatment response of nasopharyngeal carcinoma (NPC), and the recent literature provides growing evidence of the clinical utility of EBV DNA testing, particularly to inform treatment decisions for NPC patients. Despite the fact that NPC is a rare disease, the NRG Oncology cooperative group has successfully activated a phase 2/3 randomized clinical trial for NPC with international partners and in that process has discovered that the development of a harmonized EBV DNA test is absolutely critical for integration into clinical trials and for future deployment in clinical and central laboratories. In November 2015, the National Cancer Institute (NCI) convened a workshop of international experts in the treatment of NPC and EBV testing to provide a forum for discussing the state of EBV DNA testing and its clinical utility, and to stimulate consideration of future studies and clinical practice guidelines for EBV DNA. This review provides a summary of that discussion. Published by Elsevier Inc.

Problem solving strategies integrated into nursing process to promote clinical problem solving abilities of RN-BSN students.

PubMed

Wang, Jing-Jy; Lo, Chi-Hui Kao; Ku, Ya-Lie

2004-11-01

A set of problem solving strategies integrated into nursing process in nursing core courses (PSNP) was developed for students enrolled in a post-RN baccalaureate nursing program (RN-BSN) in a university in Taiwan. The purpose of this study, therefore, was to evaluate the effectiveness of PSNP on students' clinical problem solving abilities. The one-group post-test design with repeated measures was used. In total 114 nursing students with 47 full-time students and 67 part-time students participated in this study. The nursing core courses were undertaken separately in three semesters. After each semester's learning, students would start their clinical practice, and were asked to submit three written nursing process recordings during each clinic. Assignments from the three practices were named post-test I, II, and III sequentially, and provided the data for this study. The overall score of problem solving indicated that score on the post-test III was significantly better than that on post-test I and II, meaning both full-time and part-time students' clinical problem solving abilities improved at the last semester. In conclusion, problem-solving strategies integrated into nursing process designed for future RN-BSN students are recommendable.

A POC Clinical Trial for PTSD with a First-In-Class Vasopressin 1a Receptor Antagonist

DTIC Science & Technology

2017-10-01

the major objective will be to continue to recruit and enroll subjects to participate in the clinical study that will test the effect of SRX246, a...8 9. Quad Chart…………………………………………………………… 9 1. INTRODUCTION: The project will test the clinical efficacy of a novel, first-in-class vasopressin 1a...in 42 PTSD patients. In addition, the study also will test in PTSD patients i) the safety and tolerability of SRX246 (160 mg PO BID) and ii) the

Muscular exercise can cause highly pathological liver function tests in healthy men

PubMed Central

Pettersson, Jonas; Hindorf, Ulf; Persson, Paula; Bengtsson, Thomas; Malmqvist, Ulf; Werkström, Viktoria; Ekelund, Mats

2008-01-01

Aim To investigate the effect of intensive muscular exercise (weightlifting) on clinical chemistry parameters reflecting liver function in healthy men. Methods Fifteen healthy men, used to moderate physical activity not including weightlifting, performed an 1 h long weightlifting programme. Blood was sampled for clinical chemistry parameters [aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LD), gamma-glutamyl transferase (γGT), alkaline phosphatase (ALP), bilirubin, creatine kinase (CK) and myoglobin] at repeated intervals during 7 days postexercise and at a follow-up examination 10–12 days postexercise. Results Five out of eight studied clinical chemistry parameters (AST, ALT, LD, CK and myoglobin) increased significantly after exercise (P < 0.01) and remained increased for at least 7 days postexercise. Bilirubin, γGT and ALP remained within the normal range. Conclusion The liver function parameters, AST and ALT, were significantly increased for at least 7 days after the exercise. In addition, LD and, in particular, CK and myoglobin showed highly elevated levels. These findings highlight the importance of imposing restrictions on weightlifting prior to and during clinical studies. Intensive muscular exercise, e.g. weightlifting, should also be considered as a cause of asymptomatic elevations of liver function tests in daily clinical practice. What is already known about this subject The occurrence of idiosyncratic drug hepatotoxicity is a major problem in all phases of clinical drug development and the leading cause of postmarketing warnings and withdrawals.Physical exercise can result in transient elevations of liver function tests.There is no consensus in the literature on which forms of exercise may cause changes in liver function tests and to what extent. What this study adds Weightlifting results in profound increases in liver function tests in healthy men used to moderate physical activity, not including weightlifting.Liver function tests are significantly increased for at least 7 days after weightlifting.It is important to impose relevant restrictions on heavy muscular exercise prior to and during clinical studies. PMID:17764474

Clinical application of pharmacogenetics: focusing on practical issues.

PubMed

Chang, Matthew T; McCarthy, Jeanette J; Shin, Jaekyu

2015-01-01

Recent large-scale genetic-based studies have transformed the field of pharmacogenetics to identify, characterize and leverage genetic information to inform patient care. Genetic testing can be used to alter drug selection, optimize drug dosing and prevent unnecessary adverse events. As precision medicine becomes the mainstay in the clinic, it becomes critical for clinicians to utilize pharmacogenetics to guide patient care. One primary challenge is identifying patients where genetic tests that can potentially impact patient care. To address this challenge, our review highlights many practical issues clinicians may encounter: identifying candidate patients and clinical laboratories for pharmacogenetic testing, selecting highly curated resources to help asses test validity, reimbursing costs of pharmacogenetic tests, and interpreting of pharmacogenetic test results.

Certainty rating in pre-and post-tests of study modules in an online clinical pharmacy course - A pilot study to evaluate teaching and learning.

PubMed

Luetsch, Karen; Burrows, Judith

2016-10-14

Graduate and post-graduate education for health professionals is increasingly delivered in an e-learning environment, where automated, continuous formative testing with integrated feedback can guide students' self-assessment and learning. Asking students to rate the certainty they assign to the correctness of their answers to test questions can potentially provide deeper insights into the success of teaching, with test results informing course designers whether learning outcomes have been achieved. It may also have implications for decision making in clinical practice. A study of pre-and post-tests for five study modules was designed to evaluate the teaching and learning within a pharmacotherapeutic course in an online postgraduate clinical pharmacy program. Certainty based marking of multiple choice questions (MCQ) was adapted for formative pre- and post-study module testing by asking students to rate their certainty of correctness of MCQ answers. Paired t-tests and a coding scheme were used to analyse changes in answers and certainty between pre-and post-tests. A survey evaluated students' experience with the novel formative testing design. Twenty-nine pharmacists enrolled in the postgraduate program participated in the study. Overall 1315 matched pairs of MCQ answers and certainty ratings between pre- and post-module tests were available for evaluation. Most students identified correct answers in post-tests and increased their certainty compared to pre-tests. Evaluation of certainty ratings in addition to correctness of answers identified MCQs and topic areas for revision to course designers. A survey of students showed that assigning certainty ratings to their answers assisted in structuring and focusing their learning throughout online study modules, facilitating identification of areas of uncertainty and gaps in their clinical knowledge. Adding certainty ratings to MCQ answers seems to engage students with formative testing and feedback and focus their learning in a web-based postgraduate pharmacy course. It also offers deeper insight into the successful delivery of online course content, identifying areas for improvement of teaching and content delivery as well as test question design.

A comprehensive test of clinical reasoning for medical students: An olympiad experience in Iran

PubMed Central

Monajemi, Alireza; Arabshahi, Kamran Soltani; Soltani, Akbar; Arbabi, Farshid; Akbari, Roghieh; Custers, Eugene; Hadadgar, Arash; Hadizadeh, Fatemeh; Changiz, Tahereh; Adibi, Peyman

2012-01-01

Background: Although some tests for clinical reasoning assessment are now available, the theories of medical expertise have not played a major role in this filed. In this paper, illness script theory was chose as a theoretical framework and contemporary clinical reasoning tests were put together based on this theoretical model. Materials and Methods: This paper is a qualitative study performed with an action research approach. This style of research is performed in a context where authorities focus on promoting their organizations’ performance and is carried out in the form of teamwork called participatory research. Results: Results are presented in four parts as basic concepts, clinical reasoning assessment, test framework, and scoring. Conclusion: we concluded that no single test could thoroughly assess clinical reasoning competency, and therefore a battery of clinical reasoning tests is needed. This battery should cover all three parts of clinical reasoning process: script activation, selection and verification. In addition, not only both analytical and non-analytical reasoning, but also both diagnostic and management reasoning should evenly take into consideration in this battery. This paper explains the process of designing and implementing the battery of clinical reasoning in the Olympiad for medical sciences students through an action research. PMID:23555113

Clinical competency evaluation of Brazilian chiropractic interns

PubMed Central

Facchinato, Ana Paula A.; Benedicto, Camila C.; Mora, Aline G.; Cabral, Dayane M.C.; Fagundes, Djalma J.

2015-01-01

Objective This study compares the results of an objective structured clinical examination (OSCE) between 2 groups of students before an internship and after 6 months of clinical practice in an internship. Methods Seventy-two students participated, with 36 students in each cohort. The OSCEs were performed in the simulation laboratory before the participants' clinical practice internship and after 6 months of the internship. Students were tested in 9 stations for clinical skills and knowledge. The same procedures were repeated for both cohorts. The t test was used for unpaired parametric samples and Fisher's exact test was used for comparison of proportions. Results There was no difference in the mean final score between the 2 groups (p = .34 for test 1; p = .08 for test 2). The performance of the students in group 1 was not significantly different when performed before and after 6 months of clinical practice, but in group 2 there was a significant decrease in the average score after 6 months of clinical practice. Conclusions There was no difference in the cumulative average score for the 2 groups before and after 6 months of clinical practice in the internship. There were differences within the cohorts, however, with a significant decrease in the average score in group 2. Issues pertaining to test standardization and student motivation for test 2 may have influenced the scores. PMID:25588200

Clinical verification of a unilateral otolith test

NASA Astrophysics Data System (ADS)

Wetzig, J.; Hofstetter-Degen, K.; Maurer, J.; von Baumgarten, R. J.

In a previous study 13 we reported promising results for a new test to differentiate in vivo unilateral otolith functions. That study pointed to a need for further validation on known pathological cases. In this presentation we will detail the results gathered on a group of clinically verified vestibular defectives (verum) and a normal (control) group. The subjects in the verum group were former patients of the ENT clinic of the university hospital. These subjects had usually suffered from neurinoma of the VIIth cranial nerve or inner ear infections. All had required surgical intervention including removal of the vestibular system. The patients were contacted usually two or more years postoperatively. A group of students from the pre- and clinical phase of medical training served as control. Both groups were subjected to standardized clinical tests. These tests served to reconfirm the intra- or postoperative diagnosis of unilateral vestibular loss in the verum group. In the control group they had to establish the normalcy of the responses of the vestibular system. Both groups then underwent testing on our exccentric rotary chair in the manner described before 13. Preliminary results of the trials indicate that this test may indeed for the first time offer a chance to look at isolated otolith apparati in vivo.

Clinic flow for STI, HIV, and TB patients in an urban infectious disease clinic offering point-of-care testing services in Durban, South Africa.

PubMed

Stime, Katrina J; Garrett, Nigel; Sookrajh, Yukteshwar; Dorward, Jienchi; Dlamini, Ntuthu; Olowolagba, Ayo; Sharma, Monisha; Barnabas, Ruanne V; Drain, Paul K

2018-05-11

Many clinics in Southern Africa have long waiting times. The implementation of point-of-care (POC) tests to accelerate diagnosis and improve clinical management in resource-limited settings may improve or worsen clinic flow and waiting times. The objective of this study was to describe clinic flow with special emphasis on the impact of POC testing at a large urban public healthcare clinic in Durban, South Africa. We used time and motion methods to directly observe patients and practitioners. We created patient flow maps and recorded individual patient waiting and consultation times for patients seeking STI, TB, or HIV care. We conducted semi-structured interviews with 20 clinic staff to ascertain staff opinions on clinic flow and POC test implementation. Among 121 observed patients, the total number of queues ranged from 4 to 7 and total visit times ranged from 0:14 (hours:minutes) to 7:38. Patients waited a mean of 2:05 for standard-of-care STI management, and approximately 4:56 for STI POC diagnostic testing. Stable HIV patients who collected antiretroviral therapy refills waited a mean of 2:42 in the standard queue and 2:26 in the fast-track queue. A rapid TB test on a small sample of patients with the Xpert MTB/RIF assay and treatment initiation took a mean of 6:56, and 40% of patients presenting with TB-related symptoms were asked to return for an additional clinic visit to obtain test results. For all groups, the mean clinical assessment time with a nurse or physician was 7 to 9 min, which accounted for 2 to 6% of total visit time. Staff identified poor clinic flow and personnel shortages as areas of concern that may pose challenges to expanding POC tests in the current clinic environment. This busy urban clinic had multiple patient queues, long clinical visits, and short clinical encounters. Although POC testing ensured patients received a diagnosis sooner, it more than doubled the time STI patients spent at the clinic and did not result in same-day diagnosis for all patients screened for TB. Further research on implementing POC testing efficiently into care pathways is required to make these promising assays a success.

The clinical utility of naturalistic action test in differentiating mild cognitive impairment from early dementia in memory clinic.

PubMed

Bruce, Irene; Ntlholang, Ontefetse; Crosby, Lisa; Cunningham, Conal; Lawlor, Brian

2016-03-01

This study aimed to examine the validity of the Naturalistic Action Test in differentiating Mild Cognitive Impairment from early dementia compared to clinical diagnosis and ascertain Naturalistic Action Test cut-off points. This was a cross-sectional study of 70 consecutive patients diagnosed with Mild Cognitive Impairment attending the memory clinic in St James's Hospital, Dublin, Ireland. Patients with a diagnosis of Mild Cognitive Impairment who attended for routine annual assessment were asked to participate in the study. The Naturalistic Action Test was carried out after the patient had completed their routine assessment in the clinic. The Area under the Curve, AUC ± SE was 0.808 ± 0.058, p < 0.001 with 95% CI (0.695-0.922). There was concordance in 40 and discrepancy in 30 patients between the NAT and the gold standard consensus diagnosis (PPV 38%, NPV 96%, sensitivity 94%, specificity 46% and accuracy 59%) using cut-off point of ≥14 for normal function on Naturalistic Action Test. The difference was not related to age, sex, level of education or informant. Using the Youden index, we determined a Naturalistic Action Test cut-off score of ≥11 for Mild Cognitive Impairment in our study (PPV 50%, NPV 91%, sensitivity 78%, specificity 73% and accuracy of 74%). There was discrepancy in 18 patients using the new cut-off point (≥11 for Mild Cognitive Impairment vs ≤10 for dementia). The Naturalistic Action Test is a useful tool that can increase diagnostic accuracy in differentiating Mild Cognitive Impairment from early dementia. Copyright © 2015 John Wiley & Sons, Ltd.

Who tests whom? A comprehensive overview of Chlamydia trachomatis test practices in a Dutch region among different STI care providers for urogenital, anorectal and oropharyngeal sites in young people: a cross-sectional study.

PubMed

den Heijer, Casper D J; van Liere, G A F S; Hoebe, C J P A; van Bergen, J E A M; Cals, J W L; Stals, F S; Dukers-Muijrers, N H T M

2016-05-01

To evaluate and compare Chlamydia trachomatis (CT) diagnostic test practices of different sexually transmitted infection (STI) care providers in 16-29 year olds from one defined geographic Dutch region (280,000 inhabitants). Both number and proportion of positive CT tests (ie, test positivity) were assessed, and factors associated with these outcomes. Data on laboratory testing and diagnosis of urogenital, anorectal and oropharyngeal CT between 2006 and 2010 were retrieved from general practitioners (GPs), gynaecologists, an STI clinic and a population-based chlamydia screening programme. Multivariable regression analyses explored associations between age, sex, test year, socio-economic status (SES) and STI care provider and the outcomes being the number of tests and test positivity. Overall, 22,831 tests were performed (1868 positive; 8.2%). Extragenital (ie, anorectal and oropharyngeal) tests accounted for 4% of all tests (7.5% positive) and were almost exclusively (99%) performed by the STI clinic. STI clinics tested most men (37.2% of all tested men), whereas GPs tested most women (29.9% of all tested women). GPs and STI clinics accounted for 73.3% (1326/1808) of urogenital CT diagnoses. In women, the number of tests increased with age, whereas test positivity decreased for all STI care providers. Lower SES was associated with higher test positivity in GP and gynaecology patients. STI clinics performed most CT tests in men, whereas GPs performed most CT tests in women. GPs and STI clinics accounted for the majority of positives. Extragenital CT testing is rarely performed outside the STI clinic and needs to be promoted, especially in men who have sex with men. 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/

Central implementation strategies outperform local ones in improving HIV testing in Veterans Healthcare Administration facilities.

PubMed

Goetz, Matthew Bidwell; Hoang, Tuyen; Knapp, Herschel; Burgess, Jane; Fletcher, Michael D; Gifford, Allen L; Asch, Steven M

2013-10-01

Pilot data suggest that a multifaceted approach may increase HIV testing rates, but the scalability of this approach and the level of support needed for successful implementation remain unknown. To evaluate the effectiveness of a scaled-up multi-component intervention in increasing the rate of risk-based and routine HIV diagnostic testing in primary care clinics and the impact of differing levels of program support. Three arm, quasi-experimental implementation research study. Veterans Health Administration (VHA) facilities. Persons receiving primary care between June 2009 and September 2011 INTERVENTION: A multimodal program, including a real-time electronic clinical reminder to facilitate HIV testing, provider feedback reports and provider education, was implemented in Central and Local Arm Sites; sites in the Central Arm also received ongoing programmatic support. Control Arm sites had no intervention Frequency of performing HIV testing during the 6 months before and after implementation of a risk-based clinical reminder (phase I) or routine clinical reminder (phase II). The adjusted rate of risk-based testing increased by 0.4 %, 5.6 % and 10.1 % in the Control, Local and Central Arms, respectively (all comparisons, p < 0.01). During phase II, the adjusted rate of routine testing increased by 1.1 %, 6.3 % and 9.2 % in the Control, Local and Central Arms, respectively (all comparisons, p < 0.01). At study end, 70-80 % of patients had been offered an HIV test. Use of clinical reminders, provider feedback, education and social marketing significantly increased the frequency at which HIV testing is offered and performed in VHA facilities. These findings support a multimodal approach toward achieving the goal of having every American know their HIV status as a matter of routine clinical practice.

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.

Clinical prediction of Gardnerella vaginalis in general practice

PubMed Central

O'Dowd, T.C.; West, R.R.

1987-01-01

In a study of 162 women with vaginal symptoms the clinical features of increased discharge, yellow discharge, 'high cheese' odour and pH greater than 5 were statistically strongly associated with the presence of Gardnerella vaginalis, confirmed by microbiological culture. The sensitivities and specificities of these clinical tests, although not as high as those of previously described sideroom tests using the amine test and microscopy for 'clue cells' nevertheless allow the clinician to predict G. vaginalis reliably and initiate treatment at first consultation. PMID:3499508

Breast Cancer: Treatment Options

MedlinePlus

... A clinical trial is a research study that tests a new approach to treatment. Doctors want to learn whether the new treatment is safe, effective, and possibly better than the standard treatment. Clinical trials can test a new drug and how often it should ...

To test or not to test? Laboratory support for the diagnosis of Lyme borreliosis: a position paper of ESGBOR, the ESCMID study group for Lyme borreliosis.

PubMed

Dessau, R B; van Dam, A P; Fingerle, V; Gray, J; Hovius, J W; Hunfeld, K-P; Jaulhac, B; Kahl, O; Kristoferitsch, W; Lindgren, P-E; Markowicz, M; Mavin, S; Ornstein, K; Rupprecht, T; Stanek, G; Strle, F

2018-02-01

Lyme borreliosis (LB) is a tick-borne infection caused by Borrelia burgdorferi sensu lato. The most frequent clinical manifestations are erythema migrans and Lyme neuroborreliosis. Currently, a large volume of diagnostic testing for LB is reported, whereas the incidence of clinically relevant disease manifestations is low. This indicates overuse of diagnostic testing for LB with implications for patient care and cost-effective health management. The recommendations provided in this review are intended to support both the clinical diagnosis and initiatives for a more rational use of laboratory testing in patients with clinically suspected LB. This is a narrative review combining various aspects of the clinical and laboratory diagnosis with an educational purpose. The literature search was based on existing systematic reviews, national and international guidelines and supplemented with specific citations. The main recommendations according to current European case definitions for LB are as follows. Typical erythema migrans should be diagnosed clinically and does not require laboratory testing. The diagnosis of Lyme neuroborreliosis requires laboratory investigation of the spinal fluid including intrathecal antibody production, and the remaining disease manifestations require testing for serum antibodies to B. burgdorferi. Testing individuals with non-specific subjective symptoms is not recommended, because of a low positive predictive value. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Test-retest reliability of the Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) scale.

PubMed

Gustafsson, Margareta; Blomberg, Karin; Holmefur, Marie

2015-07-01

The Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) scale evaluates the student nurses' perception of the learning environment and supervision within the clinical placement. It has never been tested in a replication study. The aim of the present study was to evaluate the test-retest reliability of the CLES + T scale. The CLES + T scale was administered twice to a group of 42 student nurses, with a one-week interval. Test-retest reliability was determined by calculations of Intraclass Correlation Coefficients (ICCs) and weighted Kappa coefficients. Standard Error of Measurements (SEM) and Smallest Detectable Difference (SDD) determined the precision of individual scores. Bland-Altman plots were created for analyses of systematic differences between the test occasions. The results of the study showed that the stability over time was good to excellent (ICC 0.88-0.96) in the sub-dimensions "Supervisory relationship", "Pedagogical atmosphere on the ward" and "Role of the nurse teacher". Measurements of "Premises of nursing on the ward" and "Leadership style of the manager" had lower but still acceptable stability (ICC 0.70-0.75). No systematic differences occurred between the test occasions. This study supports the usefulness of the CLES + T scale as a reliable measure of the student nurses' perception of the learning environment within the clinical placement at a hospital. Copyright © 2015 Elsevier Ltd. All rights reserved.

Health-related physical fitness measures: reference values and reference equations for use in clinical practice.

PubMed

Tveter, Anne Therese; Dagfinrud, Hanne; Moseng, Tuva; Holm, Inger

2014-07-01

To provide reference values and reference equations for frequently used clinical field tests of health-related physical fitness for use in clinical practice. Cross-sectional design. General community. Convenience sample of volunteers (N=370) between 18 and 90 years of age were recruited from a wide range of settings (ie, work sites, schools, community centers for older adults) and different geographic locations (ie, urban, suburban, rural) in southeastern Norway. Not applicable. The participants conducted 5 clinical field tests (6-minute walk test, stair test, 30-second sit-to-stand test, handgrip test, fingertip-to-floor test). The results of the field tests showed that performance remained unchanged until approximately 50 years of age; after that, performance deteriorated with increasing age. Grip strength (79%), meters walked in 6 minutes (60%), and seconds used on the stair test (59%) could be well predicted by age, sex, height, and weight in participants ≥50 years of age, whereas the performance on all tests was less well predicted in participants <50 years of age. The reference values and reference equations provided in this study may increase the applicability and interpretability of the 6-minute walk test, stair test, 30-second sit-to-stand test, handgrip test, and fingertip-to-floor test in clinical practice. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Impact of add-on laboratory testing at an academic medical center: a five year retrospective study.

PubMed

Nelson, Louis S; Davis, Scott R; Humble, Robert M; Kulhavy, Jeff; Aman, Dean R; Krasowski, Matthew D

2015-01-01

Clinical laboratories frequently receive orders to perform additional tests on existing specimens ('add-ons'). Previous studies have examined add-on ordering patterns over short periods of time. The objective of this study was to analyze add-on ordering patterns over an extended time period. We also analyzed the impact of a robotic specimen archival/retrieval system on add-on testing procedure and manual effort. In this retrospective study at an academic medical center, electronic health records from were searched to obtain all add-on orders that were placed in the time period of May 2, 2009 to December 31, 2014. During the time period of retrospective study, 880,359 add-on tests were ordered on 96,244 different patients. Add-on testing comprised 3.3 % of total test volumes. There were 443,411 unique ordering instances, leading to an average of 1.99 add-on tests per instance. Some patients had multiple episodes of add-on test orders at different points in time, leading to an average of 9.15 add-on tests per patient. The majority of add-on orders were for chemistry tests (78.8 % of total add-ons) with the next most frequent being hematology and coagulation tests (11.2 % of total add-ons). Inpatient orders accounted for 66.8 % of total add-on orders, while the emergency department and outpatient clinics had 14.8 % and 18.4 % of total add-on orders, respectively. The majority of add-ons were placed within 8 hours (87.3 %) and nearly all by 24 hours (96.8 %). Nearly 100 % of add-on orders within the emergency department were placed within 8 hours. The introduction of a robotic specimen archival/retrieval unit saved an average of 2.75 minutes of laboratory staff manual time per unique add-on order. This translates to 24.1 hours/day less manual effort in dealing with add-on orders. Our study reflects the previous literature in showing that add-on orders significantly impact the workload of the clinical laboratory. The majority of add-on orders are clinical chemistry tests, and most add-on orders occur within 24 hours of original specimen collection. Robotic specimen archival/retrieval units can reduce manual effort in the clinical laboratory associated with add-on orders.

Usability Testing of a Complex Clinical Decision Support Tool in the Emergency Department: Lessons Learned.

PubMed

Press, Anne; McCullagh, Lauren; Khan, Sundas; Schachter, Andy; Pardo, Salvatore; McGinn, Thomas

2015-09-10

As the electronic health record (EHR) becomes the preferred documentation tool across medical practices, health care organizations are pushing for clinical decision support systems (CDSS) to help bring clinical decision support (CDS) tools to the forefront of patient-physician interactions. A CDSS is integrated into the EHR and allows physicians to easily utilize CDS tools. However, often CDSS are integrated into the EHR without an initial phase of usability testing, resulting in poor adoption rates. Usability testing is important because it evaluates a CDSS by testing it on actual users. This paper outlines the usability phase of a study, which will test the impact of integration of the Wells CDSS for pulmonary embolism (PE) diagnosis into a large urban emergency department, where workflow is often chaotic and high stakes decisions are frequently made. We hypothesize that conducting usability testing prior to integration of the Wells score into an emergency room EHR will result in increased adoption rates by physicians. The objective of the study was to conduct usability testing for the integration of the Wells clinical prediction rule into a tertiary care center's emergency department EHR. We conducted usability testing of a CDS tool in the emergency department EHR. The CDS tool consisted of the Wells rule for PE in the form of a calculator and was triggered off computed tomography (CT) orders or patients' chief complaint. The study was conducted at a tertiary hospital in Queens, New York. There were seven residents that were recruited and participated in two phases of usability testing. The usability testing employed a "think aloud" method and "near-live" clinical simulation, where care providers interacted with standardized patients enacting a clinical scenario. Both phases were audiotaped, video-taped, and had screen-capture software activated for onscreen recordings. Phase I: Data from the "think-aloud" phase of the study showed an overall positive outlook on the Wells tool in assessing a patient for a PE diagnosis. Subjects described the tool as "well-organized" and "better than clinical judgment". Changes were made to improve tool placement into the EHR to make it optimal for decision-making, auto-populating boxes, and minimizing click fatigue. Phase II: After incorporating the changes noted in Phase 1, the participants noted tool improvements. There was less toggling between screens, they had all the clinical information required to complete the tool, and were able to complete the patient visit efficiently. However, an optimal location for triggering the tool remained controversial. This study successfully combined "think-aloud" protocol analysis with "near-live" clinical simulations in a usability evaluation of a CDS tool that will be implemented into the emergency room environment. Both methods proved useful in the assessment of the CDS tool and allowed us to refine tool usability and workflow.

MOON-test - determination of motor performance in the pediatric oncology.

PubMed

Götte, M; Kesting, S; Albrecht, C; Worth, A; Bös, K; Boos, J

2013-05-01

Pediatric cancer patients suffer from various negative consequences due to the disease, the medical therapy and the inactivity during the intensive treatment. Only few studies have systematically identified the adverse effects of cancer on motor performance in childhood. To determine the motor performance of pediatric cancer patients, a motor performance test was developed which is applicable for this specific patient group. Eight test items with reference values for healthy children were merged to the MOON-test (test for motor performance in the oncology). MOON was tested for feasibility and acceptance in 33 patients aged 4-18 years. Feasibility was confirmed for children with different types of cancer (hematological malignancies and solid tumors) and with amputation, endoprosthesis, during aplasia as well as reduced general condition. Furthermore the patients showed a broad acceptance. Based on the study findings, the use of MOON-test as a standardized motor performance diagnostic tool in clinical routine of oncological acute clinics as well as rehabilitation clinics can be recommended.· © Georg Thieme Verlag KG Stuttgart · New York.

Inter- and intra-observer reliability of clinical movement-control tests for marines

PubMed Central

2012-01-01

Background Musculoskeletal disorders particularly in the back and lower extremities are common among marines. Here, movement-control tests are considered clinically useful for screening and follow-up evaluation. However, few studies have addressed the reliability of clinical tests, and no such published data exists for marines. The present aim was therefore to determine the inter- and intra-observer reliability of clinically convenient tests emphasizing movement control of the back and hip among marines. A secondary aim was to investigate the sensitivity and specificity of these clinical tests for discriminating musculoskeletal pain disorders in this group of military personnel. Methods This inter- and intra-observer reliability study used a test-retest approach with six standardized clinical tests focusing on movement control for back and hip. Thirty-three marines (age 28.7 yrs, SD 5.9) on active duty volunteered and were recruited. They followed an in-vivo observation test procedure that covered both low- and high-load (threshold) tasks relevant for marines on operational duty. Two independent observers simultaneously rated performance as “correct” or “incorrect” following a standardized assessment protocol. Re-testing followed 7–10 days thereafter. Reliability was analysed using kappa (κ) coefficients, while discriminative power of the best-fitting tests for back- and lower-extremity pain was assessed using a multiple-variable regression model. Results Inter-observer reliability for the six tests was moderate to almost perfect with κ-coefficients ranging between 0.56-0.95. Three tests reached almost perfect inter-observer reliability with mean κ-coefficients > 0.81. However, intra-observer reliability was fair-to-moderate with mean κ-coefficients between 0.22-0.58. Three tests achieved moderate intra-observer reliability with κ-coefficients > 0.41. Combinations of one low- and one high-threshold test best discriminated prior back pain, but results were inconsistent for lower-extremity pain. Conclusions Our results suggest that clinical tests of movement control of back and hip are reliable for use in screening protocols using several observers with marines. However, test-retest reproducibility was less accurate, which should be considered in follow-up evaluations. The results also indicate that combinations of low- and high-threshold tests have discriminative validity for prior back pain, but were inconclusive for lower-extremity pain. PMID:23273285

[Diagnostic test scale SI5: Assessment of sacroiliac joint dysfunction].

PubMed

Acevedo González, Juan C; Quintero Oliveros, Silvia

2015-01-01

Sacroiliac joint dysfunction is a known cause of low back pain. We think that a diagnostic score scale (SI5) may be performed to assess diagnostic utility of clinical signs of sacroiliac joint dysfunction. The primary aim of the present study was to conduct the pilot study of our new diagnostic score scale, the SI5, for sacroiliac joint syndrome. We reviewed the literature on clinical characteristics, diagnostic tests and imaging most commonly used in diagnosing sacroiliac joint dysfunction. Our group evaluated the diagnostic utility of these aspects and we used those considered most representative to develop the SI5 diagnostic scale. The SI5 scale was applied to 22 patients with low back pain; afterwards, the standard test for diagnosing this pathology (selective blockage of the SI joint) was also performed on these patients. The sensitivity and specificity for each sign were also assessed and the diagnostic scale called SI5 was then proposed, based on these data. The most sensitive clinical tests for diagnosing SI joint dysfunction were 2 patient-reported clinical characteristics, the Laguerre Test, sacroiliac rocking test and Yeomans test (greater than 80% sensitivity). The tests with greatest diagnostic specificity (>80%) were the Lewitt test, Piedallu test and Gillet test. The proposed SI5 test score scale showed sensitivity of 73% and specificity of 71%. Sacroiliac joint syndrome has been shown to produce low back pain frequently; however, the diagnostic value of examination tests for sacroiliac joint pain has been questioned by other authors. The pilot study on the SI5 diagnostic score scale showed good sensitivity and specificity. However, the process of statistical validation of the SI5 needs to be continued. Copyright © 2014 Sociedad Española de Neurocirugía. Published by Elsevier España. All rights reserved.

Prolaris Cell Cycle Progression Test for Localized Prostate Cancer: A Health Technology Assessment

PubMed Central

Schaink, Alexis; Li, Chunmei; Wells, David; Holubowich, Corinne

2017-01-01

Background Prostate cancer is very common and many localized tumours are non-aggressive. Determining which cancers are aggressive is important for choosing the most appropriate treatment (e.g., surgery, radiation, active surveillance). Current clinical risk stratification is reliable in forecasting the prognosis of groups of men with similar clinical and pathologic characteristics, but there is residual uncertainty at the individual level. The Prolaris cell cycle progression (CCP) test, a genomic test that estimates how fast tumour cells are proliferating, could potentially be used to improve the accuracy of individual risk assessment. This health technology assessment sought to determine the clinical utility, economic impact, and patients' perceptions of the value of the CCP test in low- and intermediate-risk localized prostate cancer. Methods We conducted a systematic review of the clinical and economic evidence of the CCP test in low-and intermediate-risk, localized prostate cancer. Medical and health economic databases were searched from 2010 to June or July 2016. The critical appraisal of the clinical evidence included risk of bias and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also analyzed the potential budget impact of adding the CCP test into current practice, from the perspective the Ontario Ministry of Health and Long-Term Care. Finally, we conducted qualitative interviews with men with prostate cancer, on the factors that influenced their treatment decision-making. Results For the review of clinical effectiveness, we screened 3,021 citations, and two before–after studies met our inclusion criteria. In one study, the results of the CCP test appeared to change the treatment plan (from initial to final plan) in 64.9% of cases overall (GRADE rating of the quality of evidence: Very low). In the other study, the CCP test changed the treatment received in nearly half of cases overall, compared with the initial plan (GRADE: Very low). No evidence was available on clinical outcomes of patients whose treatment was informed by CCP results. For the review of cost-effectiveness, 100 citations were identified and screened. No studies met the inclusion criteria. In our economic evaluation, we estimated that publicly funding the CCP test would result in a total net budget impact of $41.3 million in the first 5 years, mostly due to the cost of the CCP test. In our model, the relatively small cost savings ($7.3 million) due to treatment change (increased use of active surveillance and decreased use of interventional treatment) was not large enough to offset the high cost of the test. Patients viewed the test as potentially helpful but, due to the complexity of treatment decision-making, were unsure the test would ultimately change their treatment choices. Conclusions We found no evidence to demonstrate the impact of the Prolaris CCP test on patient-important clinical outcomes. The limited evidence available shows that the test appears to provide information that, when considered in addition to clinical risk stratification, may change the treatment plan or actual treatment for some low- and intermediate-risk prostate cancer patients. As a result, there is insufficient data to inform the cost-effectiveness of the CCP test. Publicly funding the CCP test would result in a large incremental cost to the provincial budget. PMID:28572867

A new condition for assessing the clinical efficiency of a diagnostic test.

PubMed

Bokhari, Ehsan; Hubert, Lawrence

2015-09-01

When prediction using a diagnostic test outperforms simple prediction using base rates, the test is said to be "clinically efficient," a term first introduced into the literature by Meehl and Rosen (1955) in Psychological Bulletin. This article provides three equivalent conditions for determining the clinical efficiency of a diagnostic test: (a) Meehl-Rosen (Meehl & Rosen, 1955); (b) Dawes (Dawes, 1962); and (c) the Bokhari-Hubert condition, introduced here for the first time. Clinical efficiency is then generalized to situations where misclassification costs are considered unequal (for example, false negatives are more costly than false positives). As an illustration, the clinical efficiency of an actuarial device for predicting violent and dangerous behavior is examined that was developed as part of the MacArthur Violence Risk Assessment Study. (c) 2015 APA, all rights reserved.

A clinical decision support system for diagnosis of Allergic Rhinitis based on intradermal skin tests.

PubMed

Jabez Christopher, J; Khanna Nehemiah, H; Kannan, A

2015-10-01

Allergic Rhinitis is a universal common disease, especially in populated cities and urban areas. Diagnosis and treatment of Allergic Rhinitis will improve the quality of life of allergic patients. Though skin tests remain the gold standard test for diagnosis of allergic disorders, clinical experts are required for accurate interpretation of test outcomes. This work presents a clinical decision support system (CDSS) to assist junior clinicians in the diagnosis of Allergic Rhinitis. Intradermal Skin tests were performed on patients who had plausible allergic symptoms. Based on patient׳s history, 40 clinically relevant allergens were tested. 872 patients who had allergic symptoms were considered for this study. The rule based classification approach and the clinical test results were used to develop and validate the CDSS. Clinical relevance of the CDSS was compared with the Score for Allergic Rhinitis (SFAR). Tests were conducted for junior clinicians to assess their diagnostic capability in the absence of an expert. The class based Association rule generation approach provides a concise set of rules that is further validated by clinical experts. The interpretations of the experts are considered as the gold standard. The CDSS diagnoses the presence or absence of rhinitis with an accuracy of 88.31%. The allergy specialist and the junior clinicians prefer the rule based approach for its comprehendible knowledge model. The Clinical Decision Support Systems with rule based classification approach assists junior doctors and clinicians in the diagnosis of Allergic Rhinitis to make reliable decisions based on the reports of intradermal skin tests. Copyright © 2015 Elsevier Ltd. All rights reserved.

Health-Care Referrals from Direct-to-Consumer Genetic Testing

PubMed Central

Giovanni, Monica A.; Fickie, Matthew R.; Lehmann, Lisa S.; Green, Robert C.; Meckley, Lisa M.; Veenstra, David

2010-01-01

Background: Direct-to-consumer genetic testing (DTC-GT) provides personalized genetic risk information directly to consumers. Little is known about how and why consumers then communicate the results of this testing to health-care professionals. Aim: To query specialists in clinical genetics about their experience with individuals who consulted them after DTC-GT. Methods: Invitations to participate in a questionnaire were sent to three different groups of genetic professionals, totaling 4047 invitations, asking questions about individuals who consulted them after DTC-GT. For each case reported, respondents were asked to describe how the case was referred to them, the patient's rationale for DTC-GT, and the type of DTC-GT performed. Respondents were also queried about the consequences of the consultations in terms of additional testing ordered. The costs associated with each consultation were estimated. A clinical case series was compiled based upon clinician responses. Results: The invitation resulted in 133 responses describing 22 cases of clinical interactions following DTC-GT. Most consultations (59.1%) were self-referred to genetics professionals, but 31.8% were physician referred. Among respondents, 52.3% deemed the DTC-GT to be “clinically useful.” BRCA1/2 testing was considered clinically useful in 85.7% of cases; 35.7% of other tests were considered clinically useful. Subsequent referrals from genetics professionals to specialists and/or additional diagnostic testing were common, generating individual downstream costs estimated to range from $40 to $20,600. Conclusions: This clinical case series suggests that approximately half of clinical geneticists who saw patients after DTC-GT judged that testing was clinically useful, especially the BRCA1/2 testing. Further studies are needed in larger and more diverse populations to better understand the interactions between DTC-GT and the health-care system. PMID:20979566

Health-care referrals from direct-to-consumer genetic testing.

PubMed

Giovanni, Monica A; Fickie, Matthew R; Lehmann, Lisa S; Green, Robert C; Meckley, Lisa M; Veenstra, David; Murray, Michael F

2010-12-01

direct-to-consumer genetic testing (DTC-GT) provides personalized genetic risk information directly to consumers. Little is known about how and why consumers then communicate the results of this testing to health-care professionals. to query specialists in clinical genetics about their experience with individuals who consulted them after DTC-GT. invitations to participate in a questionnaire were sent to three different groups of genetic professionals, totaling 4047 invitations, asking questions about individuals who consulted them after DTC-GT. For each case reported, respondents were asked to describe how the case was referred to them, the patient's rationale for DTC-GT, and the type of DTC-GT performed. Respondents were also queried about the consequences of the consultations in terms of additional testing ordered. The costs associated with each consultation were estimated. A clinical case series was compiled based upon clinician responses. the invitation resulted in 133 responses describing 22 cases of clinical interactions following DTC-GT. Most consultations (59.1%) were self-referred to genetics professionals, but 31.8% were physician referred. Among respondents, 52.3% deemed the DTC-GT to be "clinically useful." BRCA1/2 testing was considered clinically useful in 85.7% of cases; 35.7% of other tests were considered clinically useful. Subsequent referrals from genetics professionals to specialists and/or additional diagnostic testing were common, generating individual downstream costs estimated to range from $40 to $20,600. this clinical case series suggests that approximately half of clinical geneticists who saw patients after DTC-GT judged that testing was clinically useful, especially the BRCA1/2 testing. Further studies are needed in larger and more diverse populations to better understand the interactions between DTC-GT and the health-care system.

Design of a Tablet Computer App for Facilitation of a Molecular Blood Culture Test in Clinical Microbiology and Preliminary Usability Evaluation.

PubMed

Samson, Lasse L; Pape-Haugaard, Louise; Meltzer, Michelle C; Fuchs, Martin; Schønheyder, Henrik C; Hejlesen, Ole

2016-03-18

User mobility is an important aspect of the development of clinical information systems for health care professionals. Mobile phones and tablet computers have obtained widespread use by health care professionals, offering an opportunity for supporting the access to patient information through specialized applications (apps) while supporting the mobility of the users. The use of apps for mobile phones and tablet computers may support workflow of complex tasks, for example, molecular-based diagnostic tests in clinical microbiology. Multiplex Blood Culture Test (MuxBCT) is a molecular-based diagnostic test used for rapid identification of pathogens in positive blood cultures. To facilitate the workflow of the MuxBCT, a specialized tablet computer app was developed as an accessory to the diagnostic test. The app aims to reduce the complexity of the test by step-by-step guidance of microscopy and to assist users in reaching an exact bacterial or fungal diagnosis based on blood specimen observations and controls. Additionally, the app allows for entry of test results, and communication thereof to the laboratory information system (LIS). The objective of the study was to describe the design considerations of the MuxBCT app and the results of a preliminary usability evaluation. The MuxBCT tablet app was developed and set up for use in a clinical microbiology laboratory. A near-live simulation study was conducted in the clinical microbiology laboratory to evaluate the usability of the MuxBCT app. The study was designed to achieve a high degree of realism as participants carried out a scenario representing the context of use for the MuxBCT app. As the MuxBCT was under development, the scenario involved the use of molecular blood culture tests similar to the MuxBCT for identification of microorganisms from positive blood culture samples. The study participants were observed, and their interactions with the app were recorded. After the study, the participants were debriefed to clarify observations. Four medical laboratory technicians, for example, representative of end users of the app, participated in the clinical simulation study. Using the MuxBCT app, the study participants successfully identified and reported all microorganisms from the positive blood cultures examined. Three of the four participants reported that they found the app useful, while one study participant reported that she would prefer to make notes on paper and later enter them into the LIS. The preliminary usability evaluation results indicate that use of the MuxBCT tablet app can facilitate the workflow of the MuxBCT diagnostic test.

Prevalence of upper airway obstruction in patients with apparently asymptomatic euthyroid multi nodular goitre

PubMed Central

Menon, Sunil K.; Jagtap, Varsha S.; Sarathi, Vijaya; Lila, Anurag R.; Bandgar, Tushar R.; Menon, Padmavathy S; Shah, Nalini S.

2011-01-01

Aims: To study the prevalence of upper airway obstruction (UAO) in “apparently asymptomatic” patients with euthyroid multinodular goitre (MNG) and find correlation between clinical features, UAO on pulmonary function test (PFT) and tracheal narrowing on computerised tomography (CT). Materials and Methods: Consecutive patients with apparently asymptomatic euthyroid MNG attending thyroid clinic in a tertiary centre underwent clinical examination to elicit features of UAO, PFT, and CT of neck and chest. Statistical Analysis Used: Statistical analysis was done with SPSS version 11.5 using paired t-test, Chi square test, and Fisher's exact test. P value of <0.05 was considered to be significant. Results: Fifty-six patients (52 females and four males) were studied. The prevalence of UAO (PFT) and significant tracheal narrowing (CT) was 14.3%. and 9.3%, respectively. Clinical features failed to predict UAO or significant tracheal narrowing. Tracheal narrowing (CT) did not correlate with UAO (PFT). Volume of goitre significantly correlated with degree of tracheal narrowing. Conclusions: Clinical features do not predict UAO on PFT or tracheal narrowing on CT in apparently asymptomatic patients with euthyroid MNG. PMID:21966649

Management of Chronic Periodontitis Using Subgingival Irrigation of Ozonized Water: A Clinical and Microbiological Study.

PubMed

Issac, Annie V; Mathew, Jayan Jacob; Ambooken, Majo; Kachappilly, Arun Jose; Pk, Ajithkumar; Johny, Thomas; Vk, Linith; Samuel, Anju

2015-08-01

Adjunctive use of professional subgingival irrigation with scaling and root planing (SRP) has been found to be beneficial in eradicating the residual microorganisms in the pocket. To evaluate the effect of ozonized water subgingival irrigation on microbiologic parameters and clinical parameters namely Gingival index, probing pocket depth, and clinical attachment level. Thirty chronic periodontitis patients with probing pocket depth ≥6mm on at least one tooth on contra lateral sides of opposite arches were included in the study. The test sites were subjected to ozonized water subgingival irrigation with subgingival irrigation device fitted with a modified subgingival tip. Control sites were subjected to scaling and root planing only. The following clinical parameters were recorded initially and after 4 weeks at the test sites and control sites. Plaque Index, Gingival Index, probing pocket depth, clinical attachment level. Microbiologic sampling was done for the test at the baseline, after scaling, immediately after ozonized water subgingival irrigation and after 4 weeks. In control sites microbiologic sampling was done at the baseline, after scaling and after 4 weeks. The following observations were made after 4 weeks. The results were statistically analysed using independent t-test and paired t-test. Test sites showed a greater reduction in pocket depth and gain in clinical attachment compared to control sites. The total anaerobic counts were significantly reduced by ozonized water subgingival irrigation along with SRP compared to SRP alone. Ozonized water subgingival irrigation can improve the clinical and microbiological parameters in patients with chronic periodontitis when used as an adjunct to scaling and root planing.

Correlation between urodynamic tests, history and clinical findings in treatment of women with urinary incontinence.

PubMed

Borges, João Bosco Ramos; Guarisi, Telma; Camargo, Ana Carolina Marchesini de; Borges, Pítia Cárita de Godoy

2010-12-01

The aim of this study was to evaluate the role of urodynamic test in diagnosis of urinary incontinence, comparing detailed data of history and physical examination, and some easy- to-apply clinical tests. A cross-sectional retrospective study was carried out by reviewing the medical charts of 55 patients with complaint of loss of urine, seen at the Urogynecology Service of Women's Health Outpatient Clinic of Hospital Universitário de Jundiaí, between October 2006 and March 2007. The patients answered a specific questionnaire involving the epidemiological and physical examination variables considered in this study. They were submitted to physical examination and urodynamic tests. The complaint of loss of urine upon exertion, either isolated or associated with urge incontinence, was confirmed by urodynamic tests in most women, and only 4 of 49 symptomatic women had negative results. The clinical sign was present in 35 patients (63.6%), and 46 patients (83.6%) had the exertion component in the urodynamic test. The exertion component was observed in 10 (18%) out of 15 patients without symptoms (30%). The positive and negative predictive values of the clinical sign for diagnosis of any type of urinary incontinence in this studied group were 97.1 and 26.7%, respectively. As for the clinical complaint of urinary loss upon exertion, the positive and negative predictive values for any type of urinary incontinence were 92 and 40%, respectively. For the clinical complaint of urge incontinence, the positive and negative predictive values of 92.5 and 23.1%, respectively. It was concluded that the urodynamic evaluation is an important instrument to evaluate the severity of incontinence, although it was not necessary to diagnose loss of urine. The finding of urinary loss during physical examination had low sensitivity and specificity in diagnosis of the type of loss of urine. Urodynamic tests had better performance in demonstrating urinary incontinence in patients with complaint of incontinence upon exertion and without loss of urine seen upon physical examination than in confirming urge incontinence in patients with those symptoms.

Clinical assessment of pitch perception.

PubMed

Vaerenberg, Bart; Pascu, Alexandru; Del Bo, Luca; Schauwers, Karen; De Ceulaer, Geert; Daemers, Kristin; Coene, Martine; Govaerts, Paul J

2011-07-01

The perception of pitch has recently gained attention. At present, clinical audiologic tests to assess this are hardly available. This article reports on the development of a clinical test using harmonic intonation (HI) and disharmonic intonation (DI). Prospective collection of normative data and pilot study in hearing-impaired subjects. Tertiary referral center. Normative data were collected from 90 normal-hearing subjects recruited from 3 different language backgrounds. The pilot study was conducted on 18 hearing-impaired individuals who were selected into 3 pathologic groups: high-frequency hearing loss (HF), low-frequency hearing loss (LF), and cochlear implant users (CI). Normative data collection and exploratory diagnostics by means of the newly constructed HI/DI tests using intonation patterns to find the just noticeable difference (JND) for pitch discrimination in low-frequency harmonic complex sounds presented in a same-different task. JND for pitch discrimination using HI/DI tests in the hearing population and pathologic groups. Normative data are presented in 5 parameter statistics and box-and-whisker plots showing median JNDs of 2 (HI) and 3 Hz (DI). The results on both tests are statistically abnormal in LF and CI subjects, whereas they are not significantly abnormal in the HF group. The HI and DI tests allow the clinical assessment of low-frequency pitch perception. The data obtained in this study define the normal zone for both tests. Preliminary results indicate possible abnormal TFS perception in some hearing-impaired subjects.

Overdiagnosis across medical disciplines: a scoping review

PubMed Central

de Groot, Joris A H; Reitsma, Johannes B; Moons, Karel G M; Hooft, Lotty; Naaktgeboren, Christiana A

2017-01-01

Objective To provide insight into how and in what clinical fields overdiagnosis is studied and give directions for further applied and methodological research. Design Scoping review. Data sources Medline up to August 2017. Study selection All English studies on humans, in which overdiagnosis was discussed as a dominant theme. Data extraction Studies were assessed on clinical field, study aim (ie, methodological or non-methodological), article type (eg, primary study, review), the type and role of diagnostic test(s) studied and the context in which these studies discussed overdiagnosis. Results From 4896 studies, 1851 were included for analysis. Half of all studies on overdiagnosis were performed in the field of oncology (50%). Other prevalent clinical fields included mental disorders, infectious diseases and cardiovascular diseases accounting for 9%, 8% and 6% of studies, respectively. Overdiagnosis was addressed from a methodological perspective in 20% of studies. Primary studies were the most common article type (58%). The type of diagnostic tests most commonly studied were imaging tests (32%), although these were predominantly seen in oncology and cardiovascular disease (84%). Diagnostic tests were studied in a screening setting in 43% of all studies, but as high as 75% of all oncological studies. The context in which studies addressed overdiagnosis related most frequently to its estimation, accounting for 53%. Methodology on overdiagnosis estimation and definition provided a source for extensive discussion. Other contexts of discussion included definition of disease, overdiagnosis communication, trends in increasing disease prevalence, drivers and consequences of overdiagnosis, incidental findings and genomics. Conclusions Overdiagnosis is discussed across virtually all clinical fields and in different contexts. The variability in characteristics between studies and lack of consensus on overdiagnosis definition indicate the need for a uniform typology to improve coherence and comparability of studies on overdiagnosis. PMID:29284720

Evaluation of direct-to-consumer low-volume lab tests in healthy adults.

PubMed

Kidd, Brian A; Hoffman, Gabriel; Zimmerman, Noah; Li, Li; Morgan, Joseph W; Glowe, Patricia K; Botwin, Gregory J; Parekh, Samir; Babic, Nikolina; Doust, Matthew W; Stock, Gregory B; Schadt, Eric E; Dudley, Joel T

2016-05-02

Clinical laboratory tests are now being prescribed and made directly available to consumers through retail outlets in the USA. Concerns with these test have been raised regarding the uncertainty of testing methods used in these venues and a lack of open, scientific validation of the technical accuracy and clinical equivalency of results obtained through these services. We conducted a cohort study of 60 healthy adults to compare the uncertainty and accuracy in 22 common clinical lab tests between one company offering blood tests obtained from finger prick (Theranos) and 2 major clinical testing services that require standard venipuncture draws (Quest and LabCorp). Samples were collected in Phoenix, Arizona, at an ambulatory clinic and at retail outlets with point-of-care services. Theranos flagged tests outside their normal range 1.6× more often than other testing services (P < 0.0001). Of the 22 lab measurements evaluated, 15 (68%) showed significant interservice variability (P < 0.002). We found nonequivalent lipid panel test results between Theranos and other clinical services. Variability in testing services, sample collection times, and subjects markedly influenced lab results. While laboratory practice standards exist to control this variability, the disparities between testing services we observed could potentially alter clinical interpretation and health care utilization. Greater transparency and evaluation of testing technologies would increase their utility in personalized health management. This work was supported by the Icahn Institute for Genomics and Multiscale Biology, a gift from the Harris Family Charitable Foundation (to J.T. Dudley), and grants from the NIH (R01 DK098242 and U54 CA189201, to J.T. Dudley, and R01 AG046170 and U01 AI111598, to E.E. Schadt).

Evaluation of direct-to-consumer low-volume lab tests in healthy adults

PubMed Central

Kidd, Brian A.; Hoffman, Gabriel; Zimmerman, Noah; Li, Li; Morgan, Joseph W.; Glowe, Patricia K.; Botwin, Gregory J.; Parekh, Samir; Babic, Nikolina; Doust, Matthew W.; Stock, Gregory B.; Schadt, Eric E.; Dudley, Joel T.

2016-01-01

BACKGROUND. Clinical laboratory tests are now being prescribed and made directly available to consumers through retail outlets in the USA. Concerns with these test have been raised regarding the uncertainty of testing methods used in these venues and a lack of open, scientific validation of the technical accuracy and clinical equivalency of results obtained through these services. METHODS. We conducted a cohort study of 60 healthy adults to compare the uncertainty and accuracy in 22 common clinical lab tests between one company offering blood tests obtained from finger prick (Theranos) and 2 major clinical testing services that require standard venipuncture draws (Quest and LabCorp). Samples were collected in Phoenix, Arizona, at an ambulatory clinic and at retail outlets with point-of-care services. RESULTS. Theranos flagged tests outside their normal range 1.6× more often than other testing services (P < 0.0001). Of the 22 lab measurements evaluated, 15 (68%) showed significant interservice variability (P < 0.002). We found nonequivalent lipid panel test results between Theranos and other clinical services. Variability in testing services, sample collection times, and subjects markedly influenced lab results. CONCLUSION. While laboratory practice standards exist to control this variability, the disparities between testing services we observed could potentially alter clinical interpretation and health care utilization. Greater transparency and evaluation of testing technologies would increase their utility in personalized health management. FUNDING. This work was supported by the Icahn Institute for Genomics and Multiscale Biology, a gift from the Harris Family Charitable Foundation (to J.T. Dudley), and grants from the NIH (R01 DK098242 and U54 CA189201, to J.T. Dudley, and R01 AG046170 and U01 AI111598, to E.E. Schadt). PMID:27018593

The UK Clinical Aptitude Test and clinical course performance at Nottingham: a prospective cohort study.

PubMed

Yates, Janet; James, David

2013-02-26

The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Verbal Reasoning, Quantitative Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admission panels in advance of the selection process. Our first study showed little evidence of any predictive validity for performance in the first two years of the Nottingham undergraduate course.The study objective was to determine whether the UKCAT scores had any predictive value for the later parts of the course, largely delivered via clinical placements. Students entering the course in 2007 and who had taken the UKCAT were asked for permission to use their anonymised data in research. The UKCAT scores were incorporated into a database with routine pre-admission socio-demographics and subsequent course performance data. Correlation analysis was followed by hierarchical multivariate linear regression. The original study group comprised 204/254 (80%) of the full entry cohort. With attrition over the five years of the course this fell to 185 (73%) by Year 5. The Verbal Reasoning score and the UKCAT Total score both demonstrated some univariate correlations with clinical knowledge marks, and slightly less with clinical skills. No parts of the UKCAT proved to be an independent predictor of clinical course marks, whereas prior attainment was a highly significant predictor (p <0.001). This study of one cohort of Nottingham medical students showed that UKCAT scores at admission did not independently predict subsequent performance on the course. Whilst the test adds another dimension to the selection process, its fairness and validity in selecting promising students remains unproven, and requires wider investigation and debate by other schools.

Testing a model of research intention among U.K. clinical psychologists: a logistic regression analysis.

PubMed

Eke, Gemma; Holttum, Sue; Hayward, Mark

2012-03-01

Previous research highlights barriers to clinical psychologists conducting research, but has rarely examined U.K. clinical psychologists. The study investigated U.K. clinical psychologists' self-reported research output and tested part of a theoretical model of factors influencing their intention to conduct research. Questionnaires were mailed to 1,300 U.K. clinical psychologists. Three hundred and seventy-four questionnaires were returned (29% response-rate). This study replicated in a U.K. sample the finding that the modal number of publications was zero, highlighted in a number of U.K. and U.S. studies. Research intention was bimodally distributed, and logistic regression classified 78% of cases successfully. Outcome expectations, perceived behavioral control and normative beliefs mediated between research training environment and intention. Further research should explore how research is negotiated in clinical roles, and this issue should be incorporated into prequalification training. © 2012 Wiley Periodicals, Inc.

Comparison of clinical diagnosis and microbiological test results in vaginal infections.

PubMed

Karaca, M; Bayram, A; Kocoglu, M E; Gocmen, A; Eksi, F

2005-01-01

Lower genital tract infections continue to be a problem due to the fact that the clinical diagnosis is usually inadequate, and subsequent care is suboptimal. This study aimed at evaluating the accuracy of clinical diagnosis by comparing it with microbiologic test results, and to determine the causative agents of vaginal infections. Sixty-seven nonpregnant women (18-45 years of age) with the clinical diagnosis of lower genital tract infection were enrolled in the study. Patients were not included if they had a history of vaginal infection during the previous three-month period or intrauterine device. The clinical diagnosis was based on the combinations of symptoms, direct observation of wet mount, homogeneous discharge, vaginal pH > 4.5, and detection of the amine odor after exposure of vaginal secretions to 10% KOH. Vaginal samples were taken with two cotton swabs, one was used for pH determination, and the second was utilized for microbiological tests. Gram staining and cultures with Sabouraud agar and chocolate agar were performed for microbiological diagnosis, and the results were compared. The clinical diagnoses included 26 (38.8%) candidiasis, 18 (26.8%) bacterial vaginosis, three (4.5%) trichomoniasis, and 20 (29.9%) mixed vaginal infections. Of the 26 patients with clinical diagnoses of candidiasis, 12 (46.1%) revealed Candiada albicans, nine (34.6) patients revealed microorganisms other than candida species, and five (19.2%) patients had no growth. Five (27.8%) bacterial vaginosis patients revealed Gardnarella vaginalis and 12 patients (66.6%) did not grow any microorganism. The overall rate of accurate clinical diagnoses confirmed by microbiological test results was 43.2%. Seventeen (43.6) of the 39 microbiological test results correlated with clinical diagnosis, and no growth was observed in 28 (41.8%) cultures. We conclude that the clinical diagnosis of vaginal infection is inadequate and should be confirmed with microbiological testing if the resources are avaliable.

Analytical validation of an ultra low-cost mobile phone microplate reader for infectious disease testing.

PubMed

Wang, Li-Ju; Naudé, Nicole; Demissie, Misganaw; Crivaro, Anne; Kamoun, Malek; Wang, Ping; Li, Lei

2018-07-01

Most mobile health (mHealth) diagnostic devices for laboratory tests only analyze one sample at a time, which is not suitable for large volume serology testing, especially in low-resource settings with shortage of health professionals. In this study, we developed an ultra-low-cost clinically-accurate mobile phone microplate reader (mReader), and clinically validated this optical device for 12 infectious disease tests. The mReader optically reads 96 samples on a microplate at one time. 771 de-identified patient samples were tested for 12 serology assays for bacterial/viral infections. The mReader and the clinical instrument blindly read and analyzed all tests in parallel. The analytical accuracy and the diagnostic performance of the mReader were evaluated across the clinical reportable categories by comparison with clinical laboratorial testing results. The mReader exhibited 97.59-99.90% analytical accuracy and <5% coefficient of variation (CV). The positive percent agreement (PPA) in all 12 tests achieved 100%, negative percent agreement (NPA) was higher than 83% except for one test (42.86%), and overall percent agreement (OPA) ranged 89.33-100%. We envision the mReader can benefit underserved areas/populations and low-resource settings in rural clinics/hospitals at a low cost (~$50 USD) with clinical-level analytical quality. It has the potential to improve health access, speed up healthcare delivery, and reduce health disparities and education disparities by providing access to a low-cost spectrophotometer. Copyright © 2018 Elsevier B.V. All rights reserved.

An empirical definition of clinical supervision.

PubMed

Milne, Derek

2007-11-01

The growing recognition of clinical supervision as the basis for high-quality mental health services is apparent in policy, research and clinical practice, but an empirical definition is required to progress research and practice. A logical analysis was used to draft a working definition, and then a systematic review of 24 empirical studies of clinical supervision produced a best evidence synthesis, which was used to test and improve this definition. The logical analysis indicated that the most popular definition (Bernard & Goodyear, 1992) failed all four necessary tests of a good definition: precision, specification, operationalization and corroboration. The systematic review synthesis was then used to test the working definition, which passed these tests (with two amendments). These two complementary review approaches created a firmer basis for advancing research and practice.

Patch testing in Israeli children with suspected allergic contact dermatitis: A retrospective study and literature review.

PubMed

Zafrir, Yaron; Trattner, Akiva; Hodak, Emmillia; Eldar, Oren; Lapidoth, Moshe; Ben Amitai, Dan

2018-01-01

Childhood allergic contact dermatitis is recognized as a significant clinical problem. The objective was to evaluate the rate of positive patch tests in Israeli children with clinically suspected allergic contact dermatitis, identify possible sex and age differences, compare results with those in Israeli adults, and review pediatric studies in the literature. The study sample included 343 children and adolescents (197 female, 146 male; 1-18 years of age, mean age 11.8 years) with clinically suspected allergic contact dermatitis who underwent patch testing with a standard pediatric series of 23 allergens at a tertiary medical center from 1999 to 2012. Data on clinical characteristics and test results were collected retrospectively from the medical files. Ninety-eight subjects (28.6%) (75 girls [38.1%], 23 boys [15.8%]) had at least one positive reaction. The most frequent reactions were to nickel sulfate, followed by potassium dichromate and cobalt chloride. Nickel sulfate sensitivity was more common in girls, especially those younger than 3 years and older than 12 years. The prevalence of contact sensitization was similar in subjects with and without atopic dermatitis (50% and 51%, respectively). Nickel is the most common allergen in Israeli children, especially girls. Patch testing should be performed in children with clinically suspected allergic contact dermatitis regardless of atopic background. © 2017 Wiley Periodicals, Inc.

Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.

PubMed

Haukoos, Jason S; Hopkins, Emily; Byyny, Richard L; Conroy, Amy A; Silverman, Morgan; Eisert, Sheri; Thrun, Mark; Wilson, Michael; Boyett, Brian; Heffelfinger, James D

2009-08-01

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

Balance ability of 7 and 10 year old children in the population: results from a large UK birth cohort study.

PubMed

Humphriss, Rachel; Hall, Amanda; May, Margaret; Macleod, John

2011-01-01

The literature contains many reports of balance function in children, but these are often on atypical samples taken from hospital-based clinics and may not be generalisable to the population as a whole. The purpose of the present study is to describe balance test results from a large UK-based birth cohort study. Data from the Avon Longitudinal Study of Parents and Children (ALSPAC) were analysed. A total of 5402 children completed the heel-to-toe walking test at age 7 years. At age 10 years, 6915 children underwent clinical tests of balance including beam-walking, standing heel-to-toe on a beam and standing on one leg. A proportion of the children returned to the clinic for retesting within 3 months allowing test-retest agreement to be measured. Frequency distributions for each of the balance tests are given. Correlations between measures of dynamic balance at ages 7 and 10 years were weak. The static balance of 10 year old children was found to be poorer with eyes closed than with eyes open, and poorer in boys than in girls for all measures. Balance on one leg was poorer than heel-to-toe balance on a beam. A significant learning effect was found when first and second attempts of the tests were compared. Measures of static and dynamic balance appeared independent. Consistent with previous reports in the literature, test-retest reliability was found to be low. This study provides information about the balance ability of children aged 7 and 10 years and provides clinicians with reference data for balance tests commonly used in the paediatric clinic. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Home-based HIV testing for men preferred over clinic-based testing by pregnant women and their male partners, a nested cross-sectional study.

PubMed

Osoti, Alfred Onyango; John-Stewart, Grace; Kiarie, James Njogu; Barbra, Richardson; Kinuthia, John; Krakowiak, Daisy; Farquhar, Carey

2015-07-30

Male partner HIV testing and counseling (HTC) is associated with enhanced uptake of prevention of mother-to-child HIV transmission (PMTCT), yet male HTC during pregnancy remains low. Identifying settings preferred by pregnant women and their male partners may improve male involvement in PMTCT. Participants in a randomized clinical trial (NCT01620073) to improve male partner HTC were interviewed to determine whether the preferred male partner HTC setting was the home, antenatal care (ANC) clinic or VCT center. In this nested cross sectional study, responses were evaluated at baseline and after 6 weeks. Differences between the two time points were compared using McNemar's test and correlates of preference were determined using logistic regression. Among 300 pregnant female participants, 54% preferred home over ANC clinic testing (34.0%) or VCT center (12.0%). Among 188 male partners, 68% preferred home-based HTC to antenatal clinic (19%) or VCT (13%). Men who desired more children and women who had less than secondary education or daily income < $2 USD were more likely to prefer home-based over other settings (p < 0.05 for all comparisons). At 6 weeks, the majority of male (81%) and female (65%) participants recommended home over alternative HTC venues. Adjusting for whether or not the partner was tested during follow-up did not significantly alter preferences. Pregnant women and their male partners preferred home-based compared to clinic or VCT-center based male partner HTC. Home-based HTC during pregnancy appears acceptable and may improve male testing and involvement in PMTCT.

[Safety evaluation and risk control measures of Cassiae Semen].

PubMed

Zhao, Yi-Meng; Wu, Li; Zhang, Shuo; Zhang, Li; Gao, Xue-Min; Sun, Xiao-Bo; Wang, Chun

2017-11-01

In this study, the authors reviewed domestic and foreign literatures, conducted the textual research on origin and development of Cassia Semen, studied records in ancient books and ancient and modern literatures, clinical adverse reactions and relevant experimental studies in recent years, and summarized the clinical features and influencing factors related to the safety of Cassiae Semen. According to the findings,Cassia Semen's safety risks are mainly liver and kidney system damages, with the main clinical features of fatigue, anorexia, disgusting of oil, yellow urine and gray stool; digestive system injury, with the main clinical features of diarrhea, abdominal distension, nausea and loose stool; reproductive system damage, with the main clinical features of vaginal bleeding. Allergic reactions and clinical adverse events, with the main clinical features for numb mouth, itching skin, nausea and vomiting, diarrhea, wheezing and lip cyanosis were also reported. The toxicological studies on toxic components of Cassiae Semen obtusifolia were carried out through acute toxicity test, subacute toxicity test, subchronic toxicity test and chronic toxicity test. Risk factors might include patients, compatibility and physicians. Physicians should strictly abide by the medication requirements in the Pharmacopoeia, pay attention to rational compatibility, appropriate dosage,correct usage and appropriate processing, control the dosage below 15 g to avoid excessive intake, strictly control the course of treatment to avoid accumulated poisoning caused by long-term administration. At the same time, clinicians should pay attention to the latest research progress, update the knowledge structure, quickly find the latest and useful materials from clinical practice, scientific research and drug information and other literatures, make evaluation and judgment for the materials, establish a traditional Chinese medicine intelligence information library, and strengthen the control over adverse effects with a pre-warning consciousness. The authors suggested standardizing clinical medication of Cassiae Semen, and avoiding misuse or excessive use; clinicians should prescribe it in strict accordance with there commended usage and dosage in the Pharmacopoeia, and focus on the safety signal accumulation in clinic, while strengthening studies for toxic substance basis and toxicity mechanism, in order to give full play to Cassiae Semen's clinical efficacy and reduce its adverse reactions. Copyright© by the Chinese Pharmaceutical Association.

Pilot study: incorporation of pharmacogenetic testing in medication therapy management services.

PubMed

Haga, Susanne B; Allen LaPointe, Nancy M; Moaddeb, Jivan; Mills, Rachel; Patel, Mahesh; Kraus, William E

2014-11-01

Aim: To describe the rationale and design of a pilot study evaluating the integration of pharmacogenetic (PGx) testing into pharmacist-delivered medication therapy management (MTM). Study rationale: Clinical delivery approaches of PGx testing involving pharmacists may overcome barriers of limited physician knowledge about and experience with testing. Study design: We will assess the addition of PGx testing to MTM services for cardiology patients taking three or more medications including simvastatin or clopidogrel. We will measure the impact of MTM plus PGx testing on drug/dose adjustment and clinical outcomes. Factors associated with delivery, such as time to prepare and conduct MTM and consult with physicians will be recorded. Additionally, patient interest and satisfaction will be measured. Anticipated results: We anticipate that PGx testing can be practically integrated into standard a MTM service, providing a viable delivery model for testing. Conclusion: Given the lack of evidence of an effective PGx delivery models, this study will provide preliminary evidence regarding a pharmacist-delivered approach.

Psychosocial impact of prognostic genetic testing in the care of uveal melanoma patients: protocol of a controlled prospective clinical observational study.

PubMed

Erim, Yesim; Scheel, Jennifer; Breidenstein, Anja; Metz, Claudia Hd; Lohmann, Dietmar; Friederich, Hans-Christoph; Tagay, Sefik

2016-07-07

Uveal melanoma patients with a poor prognosis can be detected through genetic analysis of the tumor, which has a very high sensitivity. A large number of patients with uveal melanoma decide to receive information about their individual risk and therefore routine prognostic genetic testing is being carried out on a growing number of patients. It is obvious that a positive prediction for recidivism in the future will emotionally burden the respective patients, but research on the psychosocial impact of this innovative method is lacking. The aim of the current study is therefore to investigate the psychosocial impact (psychological distress and quality of life) of prognostic genetic testing in patients with uveal melanoma. This study is a non-randomized controlled prospective clinical observational trial. Subjects are patients with uveal melanoma, in whom genetic testing is possible. Patients who consent to genetic testing are allocated to the intervention group and patients who refuse genetic testing form the observational group. Both groups receive cancer therapy and psycho-oncological intervention when needed. The psychosocial impact of prognostic testing is investigated with the following variables: resilience, social support, fear of tumor progression, depression, general distress, cancer-specific and general health-related quality of life, attitude towards genetic testing, estimation of the perceived risk of metastasis, utilization and satisfaction with psycho-oncological crisis intervention, and sociodemographic data. Data are assessed preoperatively (at initial admission in the clinic) and postoperatively (at discharge from hospital after surgery, 6-12 weeks, 6 and 12 months after initial admission). Genetic test results are communicated 6-12 weeks after initial admission to the clinic. We created optimal conditions for investigation of the psychosocial impact of prognostic genetic testing. This study will provide information on the course of disease and psychosocial outcomes after prognostic genetic testing. We expect that empirical data from our study will give a scientific basis for medico-ethical considerations.

Cheyletiella infestation in the dog: observations on diagnostic methods and clinical signs.

PubMed

Saevik, B K; Bredal, W; Ulstein, T L

2004-10-01

The aims of this study were to evaluate the ability of diagnostic methods to detect naturally occurring Cheyletiella infestation in dogs, and to quantify and relate the number of mites and eggs present to clinical signs. Privately owned dogs with skin problems were eligible for inclusion in the study. Four diagnostic tests were performed on each dog in the following order: tape impression, hair plucking, skin scraping and vacuum cleaning. Dogs with positive test results for Cheyletiella infestation in at least one of the tests under evaluation were included in the study (n=27). The severity of pruritus and scaling was graded on a four-point fixed scale. The diagnostic findings in vacuum cleaning samples provided a semiquantitative measure of the grade of infestation. The vacuum cleaning test gave a positive test result in all dogs and was significantly more efficient than the other tests evaluated (P<0.01). The number of diagnostic findings varied considerably among the different vacuum samples. No significant relationship between the number of diagnostic findings and severity of clinical signs was detected.

Transitioning the Defense Automated Neurobehavioral Assessment (DANA) to Operational Use

DTIC Science & Technology

2013-10-01

science concentrates on CONUS-based studies such as testing DANA in clinical drug, fatigue/alertness, concussion and/or depression protocols. The...operationally deployed into the military. 15. SUBJECT TERMS neurocognitive, assessment, NCAT, concussion , mTBI, mild traumatic brain injury, psychological...concentrate)on)CONUS@based)studies)such)as)testing) DANA)in)clinical)drug,)fatigue/alertness,) concussion )and/or)depression)protocols.))The) second

Clinical, biomechanical and morphological assessment of anterior cruciate ligament Kevlar®-based artificial prosthesis in rabbit model.

PubMed

de la Garza-Castro, Santiago; González-Rivera, Carlos E; Vílchez-Cavazos, Félix; Morales-Avalos, Rodolfo; Barrera-Flores, Francisco J; Elizondo-Omaña, Rodrigo E; Soto-Dominguez, Adolfo; Acosta-Olivo, Carlos; Mendoza-Lemus, Oscar F

2017-07-27

The aim of this study was to evaluate the clinical, biomechanical and morphological characteristics of a Kevlar®-based prosthetic ligament as a synthetic graft of the anterior cruciate ligament (ACL) in an experimental animal model in rabbits. A total of 27 knees of rabbits randomly divided into 3 groups (control, ACL excision and ACL replacement with a Kevlar® prosthesis) were analyzed using clinical, biomechanical and morphological tests at 6, 12 and 18 weeks postprocedure. The mean displacement in mechanical testing was 0.73 ± 0.06 mm, 1.58 ± 0.19 mm and 0.94 ± 0.20 mm for the control, ACL excision and ACL replacement with synthetic prosthesis groups, respectively. The results showed an improvement in the stability of the knee with the use of the Kevlar® synthetic prosthesis in the biomechanical testing (p<0.05) compared with rabbits that underwent ACL excision, in addition to displacements that were larger but comparable to that in the control group (p>0.05), between the replacement group and the control group. The histological study revealed a good morphological adaptation of the synthetic material to the knee. This study proposes a new animal model for the placement and evaluation of Kevlar®-based synthetic ACL implants. The studied prosthesis showed promising behavior in the clinical and biomechanical tests and in the histological analysis. This study lays the foundation for further basic and clinical studies of artificial ACL prostheses using this material.

Clinical Assessment and Diagnostics of Patients With Hand Disorders: A Case Study Approach.

PubMed

Leow, Mabel Qi He; Lim, Rebecca Qian Ru; Tay, Shian Chao

Clinical assessment of the hand is important for diagnosing underlying hand disorders. Using a case study approach, the clinical assessment for three disorders of the hands is presented: trigger finger (stenosing tenosynovitis), carpal tunnel syndrome, and ulnar-sided wrist injury (styloid impingement). We assess the annular one pulley and finger range of motion for patients with trigger finger. To diagnose for carpal tunnel syndrome, assessment for Tinel's sign, Phalen's sign, abductor pollicis brevis muscle bulk, two-point discrimination, and obtaining a nerve conduction study are performed. Assessment for ulnar-sided wrist injury includes wrist range of motion, assessment of distal radial ulnar joint stability, provocation tests, grip strength, x-ray, and magnetic resonance imaging. This article begins with a description of the hand and wrist anatomy. For each case study, the clinical history is described, followed by a discussion of the pathophysiology, clinical assessments, and diagnostic tests.

Pilot study: assessing the clinical diagnosis of allergy in atopic children using a microarray assay in addition to skin prick testing and serum specific IgE.

PubMed

Foong, Ru-Xin; Roberts, Graham; Fox, Adam Tobias; du Toit, George

2016-01-01

Children with atopic dermatitis (AD) are at risk of developing allergy. Alongside clinical history, testing modalities include skin prick tests (SPT), specific immunoglobulin-E (sp-IgE) and recently, microarray assays. The aim of this pilot study was to assess current tests and the ISAC sIgE-112 system in the diagnosis of food and aeroallergen allergy. Children aged 0-11 years with moderate to severe AD were included. An initial allergy assessment including clinical history, SPT and sp-IgE was performed to determine food and aeroallergen sensitization. A second independent clinical assessment using the same information given to the first assessor and ISAC test results for food and aeroallergen sensitization was also made for each participant. The results from both were compared. 30 children [mean age 3.91 years (SD 3.3)] were included; 53.3 and 46.7 % had moderate and severe AD, respectively. Sp-IgE tests had a higher percentage of positive results compared to SPT and ISAC tests for common allergens. There was a significant difference between the three tests in detecting aeroallergen sensitization (p = 0.038), especially between sp-IgE and ISAC tests, but no significant difference between the tests for food allergen sensitization. There was good agreement between the two assessors; 70 % of the children had a change in diagnosis, with 60 % having at least one diagnosis added and 40 % having at least one diagnosis removed. There is a role for the use of ISAC testing in diagnosing sensitization and allergy in children with AD as it leads to a change in diagnosis for many patients. Further work is required to assess its clinical and cost effectiveness.

Organizational characteristics of HIV/syphilis testing services for men who have sex with men in South China: a social entrepreneurship analysis and implications for creating sustainable service models.

PubMed

Tucker, Joseph D; Muessig, Kathryn E; Cui, Rosa; Bien, Cedric H; Lo, Elaine J; Lee, Ramon; Wang, Kaidi; Han, Larry; Liu, Feng-Ying; Yang, Li-Gang; Yang, Bin; Larson, Heidi; Peeling, Rosanna W

2014-11-25

UNAIDS has called for greater HIV/syphilis testing worldwide just as local HIV/syphilis testing programs are cut or altered. New models are needed to make HIV/syphilis testing services sustainable while retaining their essential public health function. Social entrepreneurship, using business principles to promote a social cause, provides a framework to pilot programs that sustainably expand testing. Drawing on fieldwork in two South Chinese cities, we examined organizational and financial characteristics of current HIV/syphilis testing systems for men who have sex with men (MSM) in addition to new pilot programs focused on revenue-generation for sustainability. We undertook a qualitative study to explore organizational and financial characteristics of HIV/syphilis testing for MSM. Data were collected from men who have sex with men and policy stakeholders in Guangzhou and Hong Kong. Framework analysis was used to identify themes and then code the data. Our qualitative research study included MSM and policy stakeholders (n = 84). HIV/syphilis testing services were implemented at a wide range of organizations which we grouped broadly as independent community-based organizations (CBOs), independent clinics, and hybrid CBO-clinic sites. From an organizational perspective, hybrid CBO-clinic sites offered the inclusive environment of an MSM CBO linked to the technical capacity and trained staff of a clinic. From a financial perspective, stakeholders expressed concern about the sustainability and effectiveness of sexual health services reliant on external funding. We identified four hybrid CBO-clinic organizations that launched pilot testing programs in order to generate revenue while expanding HIV testing. Many MSM CBOs are searching for new organizational models to account for decreased external support. Hybrid CBO-clinic organizations create a strong foundation to increase HIV/syphilis testing using social entrepreneurship models in China.

Development of a clinically validated bulk failure test for ceramic crowns.

PubMed

Kelly, J Robert; Rungruanganunt, Patchnee; Hunter, Ben; Vailati, Francesca

2010-10-01

Traditional testing of ceramic crowns creates a stress state and damage modes that differ greatly from those seen clinically. There is a need to develop and communicate an in vitro testing protocol that is clinically valid. The purpose of this study was to develop an in vitro failure test for ceramic single-unit prostheses that duplicates the failure mechanism and stress state observed in clinically failed prostheses. This article first compares characteristics of traditional load-to-failure tests of ceramic crowns with the growing body of evidence regarding failure origins and stress states at failure from the examination of clinically failed crowns, finite element analysis (FEA), and data from clinical studies. Based on this analysis, an experimental technique was systematically developed and test materials were identified to recreate key aspects of clinical failure in vitro. One potential dentin analog material (an epoxy filled with woven glass fibers; NEMA grade G10) was evaluated for elastic modulus in blunt contact and for bond strength to resin cement as compared to hydrated dentin. Two bases with different elastic moduli (nickel chrome and resin-based composite) were tested for influence on failure loads. The influence of water during storage and loading (both monotonic and cyclic) was examined. Loading piston materials (G10, aluminum, stainless steel) and piston designs were varied to eliminate Hertzian cracking and to improve performance. Testing was extended from a monolayer ceramic (leucite-filled glass) to a bilayer ceramic system (glass-infiltrated alumina). The influence of cyclic rate on mean failure loads was examined (2 Hz, 10 Hz, 20 Hz) with the extremes compared statistically (t test; α=.05). Failure loads were highly influenced by base elastic modulus (t test; P<.001). Cyclic loading while in water significantly decreased mean failure loads (1-way ANOVA; P=.003) versus wet storage/dry cycling (350 N vs. 1270 N). G10 was not significantly different from hydrated dentin in terms of blunt contact elastic behavior or resin cement bond strength. Testing was successful with the bilayered ceramic, and the cycling rate altered mean failure loads only slightly (approximately 5%). Test methods and materials were developed to validly simulate many aspects of clinical failure. Copyright © 2010 The Editorial Council of the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.

Genetic testing of aetiology of intellectual disability in a dedicated physical healthcare outpatient clinic for adults with intellectual disability.

PubMed

Wallace, R A

2016-02-01

No guidelines exist for assessment of aetiology of intellectual disability in adults with intellectual disability by adult physicians, although robust guidelines exist for paediatric populations. It was speculated that the paediatric guidelines would also be suitable for adults. In rural/regional setting with limited clinical genetics, to perform a quality assurance evaluation on genetics assessment of aetiology of developmental disability in adults attending a dedicated healthcare clinic for adults with intellectual disability, compared results with paediatric standards, speculates if these seem appropriate for adults and speculates on a role for clinical genetics services. Retrospective chart audit of eligible patients looking at genetic clinical assessment, tests selected (molecular karyotype, G banding, metabolics), and yields of positive results. The results were compared with the recommended paediatric guidelines. Of 117 eligible adult patients, ideal genetic history was incomplete for 40% of patients without Down syndrome because of physician cause and lack of information. The number of abnormal genetic results increased from 46% to 66%, mainly from the molecular karyotype, though not all may have been clinically relevant. The improved yield from this test was similar to that in paediatric studies. Use of G banding and metabolic testing could be refined. Improvement can be made in clinical genetic assessment, but results generally support use of molecular karyotyping as first tier testing of cause of unknown intellectual disability in adults, as in the case for paediatric populations. The study highlights a necessary complementary role for clinical geneticists to interpret abnormal results. © 2016 Royal Australasian College of Physicians.

Development and psychometric testing of Holistic Clinical Assessment Tool (HCAT) for undergraduate nursing students.

PubMed

Wu, Xi Vivien; Enskär, Karin; Pua, Lay Hoon; Heng, Doreen Gek Noi; Wang, Wenru

2016-09-22

A major focus in nursing education is on the judgement of clinical performance, and it is a complex process due to the diverse nature of nursing practice. A holistic approach in assessment of competency is advocated. Difficulties in the development of valid and reliable assessment measures in nursing competency have resulted in the development of assessment instruments with an increase in face and content validity, but few studies have tested these instruments psychometrically. It is essential to develop a holistic assessment tool to meet the needs of the clinical education. The study aims to develop a Holistic Clinical Assessment Tool (HCAT) and test its psychometric properties. The HCAT was developed based on the systematic literature review and the findings of qualitative studies. An expert panel was invited to evaluate the content validity of the tool. A total of 130 final-year nursing undergraduate students were recruited to evaluate the psychometric properties (i.e. factor structure, internal consistency and test-retest reliability) of the tool. The HCAT has good content validity with content validity index of .979. The exploratory factor analysis reveals a four-factor structure of the tool. The internal consistency and test-retest reliability of the HCAT are satisfactory with Cronbach alpha ranging from .789 to .965 and Intraclass Correlation Coefficient ranging from .881 to .979 for the four subscales and total scale. HCAT has the potential to be used as a valid measure to evaluate clinical competence in nursing students, and provide specific and ongoing feedback to enhance the holistic clinical learning experience. In addition, HCAT functions as a tool for self-reflection, peer-assessment and guides preceptors in clinical teaching and assessment.

Does the MCAT predict medical school and PGY-1 performance?

PubMed

Saguil, Aaron; Dong, Ting; Gingerich, Robert J; Swygert, Kimberly; LaRochelle, Jeffrey S; Artino, Anthony R; Cruess, David F; Durning, Steven J

2015-04-01

The Medical College Admissions Test (MCAT) is a high-stakes test required for entry to most U. S. medical schools; admissions committees use this test to predict future accomplishment. Although there is evidence that the MCAT predicts success on multiple choice-based assessments, there is little information on whether the MCAT predicts clinical-based assessments of undergraduate and graduate medical education performance. This study looked at associations between the MCAT and medical school grade point average (GPA), Medical Licensing Examination (USMLE) scores, observed patient care encounters, and residency performance assessments. This study used data collected as part of the Long-Term Career Outcome Study to determine associations between MCAT scores, USMLE Step 1, Step 2 clinical knowledge and clinical skill, and Step 3 scores, Objective Structured Clinical Examination performance, medical school GPA, and PGY-1 program director (PD) assessment of physician performance for students graduating 2010 and 2011. MCAT data were available for all students, and the PGY PD evaluation response rate was 86.2% (N = 340). All permutations of MCAT scores (first, last, highest, average) were weakly associated with GPA, Step 2 clinical knowledge scores, and Step 3 scores. MCAT scores were weakly to moderately associated with Step 1 scores. MCAT scores were not significantly associated with Step 2 clinical skills Integrated Clinical Encounter and Communication and Interpersonal Skills subscores, Objective Structured Clinical Examination performance or PGY-1 PD evaluations. MCAT scores were weakly to moderately associated with assessments that rely on multiple choice testing. The association is somewhat stronger for assessments occurring earlier in medical school, such as USMLE Step 1. The MCAT was not able to predict assessments relying on direct clinical observation, nor was it able to predict PD assessment of PGY-1 performance. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

Clinical relevance of small copy-number variants in chromosomal microarray clinical testing.

PubMed

Hollenbeck, Dana; Williams, Crescenda L; Drazba, Kathryn; Descartes, Maria; Korf, Bruce R; Rutledge, S Lane; Lose, Edward J; Robin, Nathaniel H; Carroll, Andrew J; Mikhail, Fady M

2017-04-01

The 2010 consensus statement on diagnostic chromosomal microarray (CMA) testing recommended an array resolution ≥400 kb throughout the genome as a balance of analytical and clinical sensitivity. In spite of the clear evidence for pathogenicity of large copy-number variants (CNVs) in neurodevelopmental disorders and/or congenital anomalies, the significance of small, nonrecurrent CNVs (<500 kb) has not been well established in a clinical setting. We investigated the clinical significance of all nonpolymorphic small, nonrecurrent CNVs (<500 kb) in patients referred for CMA clinical testing over a period of 6 years, from 2009 to 2014 (a total of 4,417 patients). We excluded from our study patients with benign or likely benign CNVs and patients with only recurrent microdeletions/microduplications <500 kb. In total, 383 patients (8.67%) were found to carry at least one small, nonrecurrent CNV, of whom 176 patients (3.98%) had one small CNV classified as a variant of uncertain significance (VUS), 45 (1.02%) had two or more small VUS CNVs, 20 (0.45%) had one small VUS CNV and a recurrent CNV, 113 (2.56%) had one small pathogenic or likely pathogenic CNV, 17 (0.38%) had two or more small pathogenic or likely pathogenic CNVs, and 12 (0.27%) had one small pathogenic or likely pathogenic CNV and a recurrent CNV. Within the pathogenic group, 80 of 142 patients (56% of all small pathogenic CNV cases) were found to have a single whole-gene or exonic deletion. The themes that emerged from our study are presented in the Discussion section. Our study demonstrates the diagnostic clinical relevance of small, nonrecurrent CNVs <500 kb during CMA clinical testing and underscores the need for careful clinical interpretation of these CNVs.Genet Med 19 4, 377-385.

Laboratory and clinical evaluation of on-site urine drug testing.

PubMed

Beck, Olof; Carlsson, Sten; Tusic, Marinela; Olsson, Robert; Franzen, Lisa; Hulten, Peter

2014-11-01

Products for on-site urine drug testing offer the possibility to perform screening for drugs of abuse directly at the point-of-care. This is a well-established routine in emergency and dependency clinics but further evaluation of performance is needed due to inherent limitations with the available products. Urine drug testing by an on-site product was compared with routine laboratory methods. First, on-site testing was performed at the laboratory in addition to the routine method. Second, the on-site testing was performed at a dependency clinic and urine samples were subsequently sent to the laboratory for additional analytical investigation. The on-site testing products did not perform with assigned cut-off levels. The subjective reading between the presence of a spot (i.e. negative test result) being present or no spot (positive result) was difficult in 3.2% of the cases, and occurred for all parameters. The tests performed more accurately in drug negative samples (specificity 96%) but less accurately for detecting positives (sensitivity 79%). Of all incorrect results by the on-site test the proportion of false negatives was 42%. The overall agreement between on-site and laboratory testing was 95% in the laboratory study and 98% in the clinical study. Although a high degree of agreement was observed between on-site and routine laboratory urine drug testing, the performance of on-site testing was not acceptable due to significant number of false negative results. The limited sensitivity of on-site testing compared to laboratory testing reduces the applicability of these tests.

Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PubMed

Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

2017-02-01

This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

Psychometric characteristics of Clinical Reasoning Problems (CRPs) and its correlation with routine multiple choice question (MCQ) in Cardiology department.

PubMed

Derakhshandeh, Zahra; Amini, Mitra; Kojuri, Javad; Dehbozorgian, Marziyeh

2018-01-01

Clinical reasoning is one of the most important skills in the process of training a medical student to become an efficient physician. Assessment of the reasoning skills in a medical school program is important to direct students' learning. One of the tests for measuring the clinical reasoning ability is Clinical Reasoning Problems (CRPs). The major aim of this study is to measure psychometric qualities of CRPs and define correlation between this test and routine MCQ in cardiology department of Shiraz medical school. This study was a descriptive study conducted on total cardiology residents of Shiraz Medical School. The study population consists of 40 residents in 2014. The routine CRPs and the MCQ tests was designed based on similar objectives and were carried out simultaneously. Reliability, item difficulty, item discrimination, and correlation between each item and the total score of CRPs were all measured by Excel and SPSS software for checking psycometeric CRPs test. Furthermore, we calculated the correlation between CRPs test and MCQ test. The mean differences of CRPs test score between residents' academic year [second, third and fourth year] were also evaluated by Analysis of variances test (One Way ANOVA) using SPSS software (version 20)(α=0.05). The mean and standard deviation of score in CRPs was 10.19 ±3.39 out of 20; in MCQ, it was 13.15±3.81 out of 20. Item difficulty was in the range of 0.27-0.72; item discrimination was 0.30-0.75 with question No.3 being the exception (that was 0.24). The correlation between each item and the total score of CRP was 0.26-0.87; the correlation between CRPs test and MCQ test was 0.68 (p<0.001). The reliability of the CRPs was 0.72 as calculated by using Cronbach's alpha. The mean score of CRPs was different among residents based on their academic year and this difference was statistically significant (p<0.001). The results of this present investigation revealed that CRPs could be reliable test for measuring clinical reasoning in residents. It can be included in cardiology residency assessment programs.

The autonomic laboratory

NASA Technical Reports Server (NTRS)

Low, P. A.; Opfer-Gehrking, T. L.

1999-01-01

The autonomic nervous system can now be studied quantitatively, noninvasively, and reproducibly in a clinical autonomic laboratory. The approach at the Mayo Clinic is to study the postganglionic sympathetic nerve fibers of peripheral nerve (using the quantitative sudomotor axon reflex test [QSART]), the parasympathetic nerves to the heart (cardiovagal tests), and the regulation of blood pressure by the baroreflexes (adrenergic tests). Patient preparation is extremely important, since the state of the patient influences the results of autonomic function tests. The autonomic technologist in this evolving field needs to have a solid core of knowledge of autonomic physiology and autonomic function tests, followed by training in the performance of these tests in a standardized fashion. The range and utilization of tests of autonomic function will likely continue to evolve.

The effect of short-term workshop on improving clinical reasoning skill of medical students

PubMed Central

Yousefichaijan, Parsa; Jafari, Farshad; Kahbazi, Manijeh; Rafiei, Mohammad; Pakniyat, AbdolGhader

2016-01-01

Background: Clinical reasoning process leads clinician to get purposeful steps from signs and symptoms toward diagnosis and treatment. This research intends to investigate the effect of teaching clinical reasoning on problem-solving skills of medical students. Methods: This research is a semi-experimental study. Nineteen Medical student of the pediatric ward as case group participated in a two-day workshop for training clinical reasoning. Before the workshop, they filled out Diagnostic Thinking Inventory (DTI) questionnaires. Fifteen days after the workshop the DTI questionnaire completed and "key feature" (KF) test and "clinical reasoning problem" (CRP) test was held. 23 Medical student as the control group, without passing the clinical reasoning workshop DTI questionnaire completed, and KF test and CRP test was held. Results: The average score of the DTI questionnaire in the control group was 162.04 and in the case group before the workshop was 153.26 and after the workshop was 181.68. Compare the average score of the DTI questionnaire before and after the workshop there is a significant difference. The difference between average KF test scores in the control and the case group was not significant but between average CRP test scores was significant. Conclusion: Clinical reasoning workshop is effectiveness in promoting problem-solving skills of students. PMID:27579286

The effect of short-term workshop on improving clinical reasoning skill of medical students.

PubMed

Yousefichaijan, Parsa; Jafari, Farshad; Kahbazi, Manijeh; Rafiei, Mohammad; Pakniyat, AbdolGhader

2016-01-01

Clinical reasoning process leads clinician to get purposeful steps from signs and symptoms toward diagnosis and treatment. This research intends to investigate the effect of teaching clinical reasoning on problem-solving skills of medical students. This research is a semi-experimental study. Nineteen Medical student of the pediatric ward as case group participated in a two-day workshop for training clinical reasoning. Before the workshop, they filled out Diagnostic Thinking Inventory (DTI) questionnaires. Fifteen days after the workshop the DTI questionnaire completed and "key feature" (KF) test and "clinical reasoning problem" (CRP) test was held. 23 Medical student as the control group, without passing the clinical reasoning workshop DTI questionnaire completed, and KF test and CRP test was held. The average score of the DTI questionnaire in the control group was 162.04 and in the case group before the workshop was 153.26 and after the workshop was 181.68. Compare the average score of the DTI questionnaire before and after the workshop there is a significant difference. The difference between average KF test scores in the control and the case group was not significant but between average CRP test scores was significant. Clinical reasoning workshop is effectiveness in promoting problem-solving skills of students.

Neurophysiology of the pelvic floor in clinical practice: a systematic literature review

PubMed Central

Bianchi, Francesca; Squintani, Giovanna Maddalena; Osio, Maurizio; Morini, Alberto; Bana, Cristina; Ardolino, Gianluca; Barbieri, Sergio; Bertolasi, Laura; Caramelli, Riccardo; Cogiamanian, Filippo; Currà, Antonio; de Scisciolo, Giuseppe; Foresti, Camillo; Frasca, Vittorio; Frasson, Emma; Inghilleri, Maurizio; Maderna, Luca; Motti, Luisa; Onesti, Emanuela; Romano, Marcello Calogero; Del Carro, Ubaldo

2017-01-01

Summary Neurophysiological testing of the pelvic floor is recognized as an essential tool to identify pathophysiological mechanisms of pelvic floor disorders, support clinical diagnosis, and aid in therapeutic decisions. Nevertheless, the diagnostic value of these tests in specific neurological diseases of the pelvic floor is not completely clarified. Seeking to fill this gap, the members of the Neurophysiology of the Pelvic Floor Study Group of the Italian Clinical Neurophysiology Society performed a systematic review of the literature to gather available evidence for and against the utility of neurophysiological tests. Our findings confirm the utility of some tests in specific clinical conditions [e.g. concentric needle electromyography, evaluation of sacral reflexes and of pudendal somatosensory evoked potentials (pSEPs) in cauda equina and conus medullaris lesions, and evaluation of pSEPs and perineal sympathetic skin response in spinal cord lesions], and support their use in clinical practice. Other tests, particularly those not currently supported by high-level evidence, when employed in individual patients, should be evaluated in the overall clinical context, or otherwise used for research purposes.

The Ling 6(HL) test: typical pediatric performance data and clinical use evaluation.

PubMed

Glista, Danielle; Scollie, Susan; Moodie, Sheila; Easwar, Vijayalakshmi

2014-01-01

The Ling 6(HL) test offers a calibrated version of naturally produced speech sounds in dB HL for evaluation of detection thresholds. Aided performance has been previously characterized in adults. The purpose of this work was to evaluate and refine the Ling 6(HL) test for use in pediatric hearing aid outcome measurement. This work is presented across two studies incorporating an integrated knowledge translation approach in the characterization of normative and typical performance, and in the evaluation of clinical feasibility, utility, acceptability, and implementation. A total of 57 children, 28 normally hearing and 29 with binaural sensorineural hearing loss, were included in Study 1. Children wore their own hearing aids fitted using Desired Sensation Level v5.0. Nine clinicians from The Network of Pediatric Audiologists participated in Study 2. A CD-based test format was used in the collection of unaided and aided detection thresholds in laboratory and clinical settings; thresholds were measured clinically as part of routine clinical care. Confidence intervals were derived to characterize normal performance and typical aided performance according to hearing loss severity. Unaided-aided performance was analyzed using a repeated-measures analysis of variance. The audiologists completed an online questionnaire evaluating the quality, feasibility/executability, utility/comparative value/relative advantage, acceptability/applicability, and interpretability, in addition to recommendation and general comments sections. Ling 6(HL) thresholds were reliably measured with children 3-18 yr old. Normative and typical performance ranges were translated into a scoring tool for use in pediatric outcome measurement. In general, questionnaire respondents generally agreed that the Ling 6(HL) test was a high-quality outcome evaluation tool that can be implemented successfully in clinical settings. By actively collaborating with pediatric audiologists and using an integrated knowledge translation framework, this work supported the creation of an evidence-based clinical tool that has the potential to be implemented in, and useful to, clinical practice. More research is needed to characterize performance in alternative listening conditions to facilitate use with infants, for example. Future efforts focused on monitoring the use of the Ling 6(HL) test in daily clinical practice may help describe whether clinical use has been maintained across time and if any additional adaptations are necessary to facilitate clinical uptake. American Academy of Audiology.

Expert Systems In Medical Studies - A New Twist

NASA Astrophysics Data System (ADS)

Slagle, James R.; Long, John M.; Wick, Michael R.; Matts, John P.; Leon, Arthur S.

1986-03-01

The use of experts to evaluate large amounts of trial data results in increasingly expensive and time consuming research. We are investigating the role expert systems can play in reducing the time and expense of research projects. Current methods in large clinical studies for evaluating data are often crude and superficial. We have developed, for a large clinical trial, an expert system for analysis of treadmill exercise ECG test results. In the cases we are studying, a patient is given a treadmill exercise ECG test once a year for five years. Pairs of these exercise tests are then evaluated by cardiologists to determine the condition of the patient's heart. The results of our system show great promise for the use of expert systems in reducing the time and expense of large clinical trials.

Accuracy of physical examination for chronic lumbar radiculopathy

PubMed Central

2013-01-01

Background Clinical examination of patients with chronic lumbar radiculopathy aims to clarify whether there is nerve root impingement. The aims of this study were to investigate the association between findings at clinical examination and nerve root impingement, to evaluate the accuracy of clinical index tests in a specialised care setting, and to see whether imaging clarifies the cause of chronic radicular pain. Methods A total of 116 patients referred with symptoms of lumbar radiculopathy lasting more than 12 weeks and at least one positive index test were included. The tests were the straight leg raising test, and tests for motor muscle strength, dermatome sensory loss, and reflex impairment. Magnetic resonance imaging (n = 109) or computer tomography (n = 7) were imaging reference standards. Images were analysed at the level of single nerve root(s), and nerve root impingement was classified as present or absent. Sensitivities, specificities, and positive and negative likelihood ratios (LR) for detection of nerve root impingement were calculated for each individual index test. An overall clinical evaluation, concluding on the level and side of the radiculopathy, was performed. Results The prevalence of disc herniation was 77.8%. The diagnostic accuracy of individual index tests was low with no tests reaching positive LR >4.0 or negative LR <0.4. The overall clinical evaluation was slightly more accurate, with a positive LR of 6.28 (95% CI 1.06–37.21) for L4, 1.74 (95% CI 1.04–2.93) for L5, and 1.29 (95% CI 0.97–1.72) for S1 nerve root impingement. An overall clinical evaluation, concluding on the level and side of the radiculopathy was also performed, and receiver operating characteristic (ROC) analysis with area under the curve (AUC) calculation for diagnostic accuracy of this evaluation was performed. Conclusions The accuracy of individual clinical index tests used to predict imaging findings of nerve root impingement in patients with chronic lumbar radiculopathy is low when applied in specialised care, but clinicians’ overall evaluation improves diagnostic accuracy slightly. The tests are not very helpful in clarifying the cause of radicular pain, and are therefore inaccurate for guidance in the diagnostic workup of the patients. The study population was highly selected and therefore the results from this study should not be generalised to unselected patient populations in primary care nor to even more selected surgical populations. PMID:23837886

An Alternative Study of Transfer of Learning in Clinical Evaluation.

ERIC Educational Resources Information Center

Patel, Vimla; Cranton, Patricia A.

The use of an alternative methodology to study transfer of learning in clinical instruction during medical school was investigated. The environment in which clinical instruction takes place was examined, after which hypotheses were proposed and tested in a quasi-experimental design. The first phase of the study, an ethnographic analysis of the…

Cellular telephone interference with medical equipment.

PubMed

Tri, Jeffrey L; Severson, Rodney P; Firl, Allen R; Hayes, David L; Abenstein, John P

2005-10-01

To assess the potential electromagnetic interference (EMI) effects that new or current-generation cellular telephones have on medical devices. For this study, performed at the Mayo Clinic in Rochester, Minn, between March 9, 2004, and April 24, 2004, we tested 16 different medical devices with 6 cellular telephones to assess the potential for EMI. Two of the medical devices were tested with both new and old interface modules. The 6 cellular telephones chosen represent the different cellular technology protocols in use: Code Division Multiple Access (2 models), Global System for Mobile communications, Integrated Digital Enhanced Network, Time Division Multiple Access, and analog. The cellular telephones were tested when operating at or near their maximum power output. The medical devices, connected to clinical simulators during testing, were monitored by observing the device displays and alarms. Of 510 tests performed, the incidence of clinically important interference was 1.2%; EMI was Induced in 108 tests (21.2%). Interference occurred in 7 (44%) of the 16 devices tested. Cellular telephones can interfere with medical equipment. Technology changes in both cellular telephones and medical equipment may continue to mitigate or may worsen clinically relevant interference. Compared with cellular telephones tested in previous studies, those currently in use must be closer to medical devices before any interference is noticed. However, periodic testing of cellular telephones to determine their effects on medical equipment will be required.

A proof of concept study to assess the potential of PCR testing to detect natural Mycobacterium bovis infection in South American camelids.

PubMed

Crawshaw, Timothy R; Chanter, Jeremy I; McGoldrick, Adrian; Line, Kirsty

2014-02-07

Cases of Mycobacterium bovis infection South American camelids have been increasing in Great Britain. Current antemortem immunological tests have some limitations. Cases at post mortem examination frequently show extensive pathology. The feasibility of detecting Mycobacterium bovis DNA in clinical samples was investigated. A sensitive extraction methodology was developed and used on nasal swabs and faeces taken post-mortem to assess the potential for a PCR test to detect Mycobacterium bovis in clinical samples. The gross pathology of the studied South American camelids was scored and a significantly greater proportion of South American camelids with more severe pathology were positive in both the nasal swab and faecal PCR tests. A combination of the nasal swab and faecal PCR tests detected 63.9% of all the South American camelids with pathology that were tested. The results suggest that antemortem diagnosis of Mycobacterium bovis in South American camelids may be possible using a PCR test on clinical samples, however more work is required to determine sensitivity and specificity, and the practicalities of applying the test in the field.

Pre-test and post-test evaluation of students' perceptions of a collaborative clinical education model on the learning environment.

PubMed

Henderson, Amanda; Heel, Alison; Twentyman, Michelle; Lloyd, Belinda

2006-01-01

This study investigated the impact of a collaborative clinical education model on students' perception of the psycho-social learning environment. A pre-test and post-test quasi experimental design. A tertiary referral centre. Second and third year undergraduate nursing students were asked to rate their perceptions of the psycho-social learning environment at the completion of the clinical practicum. TOOL: The tool used to measure psycho-social perceptions of the clinical learning environment was the Clinical Learning Environment Inventory previously validated in Australian health care contexts. A collaborative arrangement with the university and ward staff where eight students are placed on a ward and a ward staff member is paid by the university to be 'off-line' from a clinical workload to supervise the students. This is in contrast to the standard facilitation model where students are placed with registered nurses in different localities under the supervision of a 'roving' registered nurse paid by the university. No significant differences were found in pre-test mean scores when comparing wards. Significant differences in post-test scores for the intervention group were identified in the sub scales of Student Involvement, Satisfaction, Personalisation and Task Orientation. The adoption of a collaborative clinical education model where students are integrated into the ward team and the team is responsible for student learning can positively enhance capacity for student learning during their clinical practicum.

Development and Implementation of a Pharmacist-Managed Clinical Pharmacogenetics Service

PubMed Central

Crews, Kristine R.; Cross, Shane J.; McCormick, John N.; Baker, Donald K.; Molinelli, Alejandro R.; Mullins, Richard; Relling, Mary V.; Hoffman, James M.

2011-01-01

Purpose The development and implementation of a pharmacist-managed Clinical Pharmacogenetics service is described. Summary Therapeutic drug monitoring (TDM) is a well-accepted role of the pharmacist. Pharmacogenetics, the study of genetic factors that influence the variability in drug response among patients, is a rapidly evolving discipline that integrates knowledge of pharmacokinetics and pharmacodynamics with modern advances in genetic testing. There is growing evidence for the clinical utility of pharmacogenetics, and pharmacists can play an essential role in the thoughtful application of pharmacogenetics to patient care. A pharmacist-managed Clinical Pharmacogenetics service was designed and implemented. The goal of the service is to provide clinical pharmacogenetic testing for gene products important to the pharmacodynamics of medications used in our patients. The service is modeled after and integrated with an already established Clinical Pharmacokinetics service. All clinical pharmacogenetic test results are first reported to one of the pharmacists, who reviews the result and provides a written consult. The consult includes an interpretation of the result and recommendations for any indicated changes to therapy. In 2009, 136 clinical pharmacogenetic tests were performed, consisting of 66 TPMT tests, 65 CYP2D6 tests, and 5 UGT1A1 tests. Our service has been met with positive clinician feedback. Conclusion Our experience demonstrates the feasibility of the design and function of a pharmacist-managed Clinical Pharmacogenetics service at an academic specialty hospital. The successful implementation of this service highlights the leadership role that pharmacists can take in moving pharmacogenetics from research to patient care, thereby potentially improving patient outcomes. PMID:21200062

Understanding the Role of P Values and Hypothesis Tests in Clinical Research.

PubMed

Mark, Daniel B; Lee, Kerry L; Harrell, Frank E

2016-12-01

P values and hypothesis testing methods are frequently misused in clinical research. Much of this misuse appears to be owing to the widespread, mistaken belief that they provide simple, reliable, and objective triage tools for separating the true and important from the untrue or unimportant. The primary focus in interpreting therapeutic clinical research data should be on the treatment ("oomph") effect, a metaphorical force that moves patients given an effective treatment to a different clinical state relative to their control counterparts. This effect is assessed using 2 complementary types of statistical measures calculated from the data, namely, effect magnitude or size and precision of the effect size. In a randomized trial, effect size is often summarized using constructs, such as odds ratios, hazard ratios, relative risks, or adverse event rate differences. How large a treatment effect has to be to be consequential is a matter for clinical judgment. The precision of the effect size (conceptually related to the amount of spread in the data) is usually addressed with confidence intervals. P values (significance tests) were first proposed as an informal heuristic to help assess how "unexpected" the observed effect size was if the true state of nature was no effect or no difference. Hypothesis testing was a modification of the significance test approach that envisioned controlling the false-positive rate of study results over many (hypothetical) repetitions of the experiment of interest. Both can be helpful but, by themselves, provide only a tunnel vision perspective on study results that ignores the clinical effects the study was conducted to measure.

Preemptive Pharmacogenomic Testing for Precision Medicine

PubMed Central

Ji, Yuan; Skierka, Jennifer M.; Blommel, Joseph H.; Moore, Brenda E.; VanCuyk, Douglas L.; Bruflat, Jamie K.; Peterson, Lisa M.; Veldhuizen, Tamra L.; Fadra, Numrah; Peterson, Sandra E.; Lagerstedt, Susan A.; Train, Laura J.; Baudhuin, Linnea M.; Klee, Eric W.; Ferber, Matthew J.; Bielinski, Suzette J.; Caraballo, Pedro J.; Weinshilboum, Richard M.; Black, John L.

2017-01-01

Significant barriers, such as lack of professional guidelines, specialized training for interpretation of pharmacogenomics (PGx) data, and insufficient evidence to support clinical utility, prevent preemptive PGx testing from being widely clinically implemented. The current study, as a pilot project for the Right Drug, Right Dose, Right Time–Using Genomic Data to Individualize Treatment Protocol, was designed to evaluate the impact of preemptive PGx and to optimize the workflow in the clinic setting. We used an 84-gene next-generation sequencing panel that included SLCO1B1, CYP2C19, CYP2C9, and VKORC1 together with a custom-designed CYP2D6 testing cascade to genotype the 1013 subjects in laboratories approved by the Clinical Laboratory Improvement Act. Actionable PGx variants were placed in patient's electronic medical records where integrated clinical decision support rules alert providers when a relevant medication is ordered. The fraction of this cohort carrying actionable PGx variant(s) in individual genes ranged from 30% (SLCO1B1) to 79% (CYP2D6). When considering all five genes together, 99% of the subjects carried an actionable PGx variant(s) in at least one gene. Our study provides evidence in favor of preemptive PGx testing by identifying the risk of a variant being present in the population we studied. PMID:26947514

Difference of Success Rates of Mineral Trioxide Aggregate Pulpotomies Performed Both by Undergraduate Dental Students and by an Expert Operator: A Retrospective Study.

PubMed

Pasini, Marco; Giuca, Maria Rita; Gatto, Roberto; Caruso, Silvia

2017-01-01

The aim of this retrospective study was to evaluate the clinical and radiographic success of pulpotomy on primary molars performed by dental students compared to that performed by an expert operator. The study was conducted on 142 second primary molars in 102 children. The patients were randomly selected from the available records. The test group (treated by dental students) included 51 subjects (28 males and 23 females, mean age: 7.2 ± 1) and the control group included 51 children (29 males and 22 females, mean age: 7.4 ± 1.2 years). After pulpotomy, a clinical and radiographic evaluation after 12 months was performed. Chi-square test and odds ratio were calculated and significance level was set at p < 0.05. The success rate was significantly lower, 81.6% ( p < 0.05), in the test group than in the control group (93%). The test group showed less clinical and radiographic success (86% and 80%, resp.) compared to the control group (97.2% for clinical success and 93% for radiographic success). Pulpotomy with MTA is an effective method that ensures a good percentage of success. The clinical experience of the operator is a contributing factor.

Interventions to evaluate fitness to drive among people with chronic conditions: Systematic review of literature.

PubMed

Marino, Marta; de Belvis, Antonio; Basso, Danila; Avolio, Maria; Pelone, Ferruccio; Tanzariello, Maria; Ricciardi, Walter

2013-01-01

When an health condition has been identified, the question of whether to continue driving depends not on a medical diagnosis, but on the functional consequences of the illness. The complex nature of physical and mental impairments and their relationship with safe driving make the availability of evidence based tools necessary for health professionals. The review aims at identifying and summarizing scientific findings concerning the relationship between neuropsychological and clinical screening tests and fitness to drive among people with chronic conditions. Studies were searched for driving ability evaluation by road test or simulator, clinical/neuropsychological examinations of participants with chronic diseases or permanent disablement impairing driving performance, primary outcomes as fatal/non-fatal traffic injuries and secondary outcomes as fitness to drive assessment. Twenty-seven studies fulfilled the inclusion criteria. Some studies included more than one clinical condition. The illness investigated were Alzheimer Disease (n=6), Parkinson Disease (n=8), Cardiovascular Accident (n=4), Traumatic Brain Injuries (n=3), Sleep Apnea Syndrome (n=2), Narcolepsy (n=1), Multiple Sclerosis (n=1) and Hepatic Encephalopathy (n=1), comorbidities (n=3). No studies match inclusion criteria about Myasthenia Gravis, Diabetes Mellitus, Renal Diseases, Hearing Disorders and Sight Diseases. No studies referred to primary outcomes. The selected studies provided opposite evidences. It would be reasonable to argue that some clinical and neuropsychological tests are effective in predicting fitness to drive even if contrasting results support that driving performance decreases as a function of clinical and neuropsychological decline in some chronic diseases. Nevertheless we found no evidence that clinical and neuropsychological screening tests would lead to a reduction in motor vehicle crashes involving chronic disabled drivers. It seems necessary to develop tests with proven validity for identifying high-risk drivers so that physicians can provide guidance to their patients in chronic conditions, and also to medical advisory boards working with licensing offices. Copyright © 2012 Elsevier Ltd. All rights reserved.

Stakeholder views on pharmacogenomic testing.

PubMed

Patel, Haridarshan N; Ursan, Iulia D; Zueger, Patrick M; Cavallari, Larisa H; Pickard, A Simon

2014-02-01

Pharmacogenomics has an important role in the evolution of personalized medicine, and its widespread uptake may ultimately depend on the interests and perspectives of key players in health care. Our aim was to summarize studies on stakeholder perspectives and attitudes toward pharmacogenomic testing. Thus, we conducted a review of original research studies that reported stakeholder views on pharmacogenomic testing using a structured approach in PubMed, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature, and EMBASE. A standardized data abstraction form was developed that included stakeholder group of interest-patients, general public, providers, and payers. Stakeholder views regarding barriers to pharmacogenetic implementation were organized into the following themes: ancillary information-related, clinical, economic, educational, ethical or legal, medical mistrust, and practicality. Of 34 studies that met our inclusion criteria, 37 perspectives were reported (15 on providers, 9 on the general public, 9 on patients, and 4 on payers). The most common topics that arose in studies of providers related to clinical usefulness of genetic data (n=11) and educational needs (n=11). Among the general public, the most common concerns were medical mistrust (n=5), insufficient education (n=5), and practicality (n=5). The most prevalent issues from the patient perspective were ethical or legal (n=6) and economic (n=5) issues. Among payers, leading issues were practicality (n=4) and clinical usefulness (n=3). There was overlap in the topics and concerns across stakeholder perspectives, including lack of knowledge about pharmacogenomic testing. Views on issues related to privacy, cost, and test result dissemination varied by stakeholder perspective. Limited research had been conducted in underrepresented groups. Efforts to address the issues raised by stakeholders may facilitate the implementation of pharmacogenomic testing into clinical practice. © 2013 American College of Clinical Pharmacy.

Regression of Moral Reasoning during Medical Education: Combined Design Study to Evaluate the Effect of Clinical Study Years

PubMed Central

Hren, Darko; Marušić, Matko; Marušić, Ana

2011-01-01

Background Moral reasoning is important for developing medical professionalism but current evidence for the relationship between education and moral reasoning does not clearly apply to medical students. We used a combined study design to test the effect of clinical teaching on moral reasoning. Methods We used the Defining Issues Test-2 as a measure of moral judgment, with 3 general moral schemas: Personal Interest, Maintaining Norms, and Postconventional Schema. The test was applied to 3 consecutive cohorts of second year students in 2002 (n = 207), 2003 (n = 192), and 2004 (n = 139), and to 707 students of all 6 study years in 2004 cross-sectional study. We also tested 298 age-matched controls without university education. Results In the cross-sectional study, there was significant main effect of the study year for Postconventional (F(5,679) = 3.67, P = 0.003) and Personal Interest scores (F(5,679) = 3.38, P = 0.005). There was no effect of the study year for Maintaining Norms scores. 3rd year medical students scored higher on Postconventional schema score than all other study years (p<0.001). There were no statistically significant differences among 3 cohorts of 2nd year medical students, demonstrating the absence of cohort or point-of-measurement effects. Longitudinal study of 3 cohorts demonstrated that students regressed from Postconventional to Maintaining Norms schema-based reasoning after entering the clinical part of the curriculum. Interpretation Our study demonstrated direct causative relationship between the regression in moral reasoning development and clinical teaching during medical curriculum. The reasons may include hierarchical organization of clinical practice, specific nature of moral dilemmas faced by medical students, and hidden medical curriculum. PMID:21479204

Clinical classification in low back pain: best-evidence diagnostic rules based on systematic reviews.

PubMed

Petersen, Tom; Laslett, Mark; Juhl, Carsten

2017-05-12

Clinical examination findings are used in primary care to give an initial diagnosis to patients with low back pain and related leg symptoms. The purpose of this study was to develop best evidence Clinical Diagnostic Rules (CDR] for the identification of the most common patho-anatomical disorders in the lumbar spine; i.e. intervertebral discs, sacroiliac joints, facet joints, bone, muscles, nerve roots, muscles, peripheral nerve tissue, and central nervous system sensitization. A sensitive electronic search strategy using MEDLINE, EMBASE and CINAHL databases was combined with hand searching and citation tracking to identify eligible studies. Criteria for inclusion were: persons with low back pain with or without related leg symptoms, history or physical examination findings suitable for use in primary care, comparison with acceptable reference standards, and statistical reporting permitting calculation of diagnostic value. Quality assessments were made independently by two reviewers using the Quality Assessment of Diagnostic Accuracy Studies tool. Clinical examination findings that were investigated by at least two studies were included and results that met our predefined threshold of positive likelihood ratio ≥ 2 or negative likelihood ratio ≤ 0.5 were considered for the CDR. Sixty-four studies satisfied our eligible criteria. We were able to construct promising CDRs for symptomatic intervertebral disc, sacroiliac joint, spondylolisthesis, disc herniation with nerve root involvement, and spinal stenosis. Single clinical test appear not to be as useful as clusters of tests that are more closely in line with clinical decision making. This is the first comprehensive systematic review of diagnostic accuracy studies that evaluate clinical examination findings for their ability to identify the most common patho-anatomical disorders in the lumbar spine. In some diagnostic categories we have sufficient evidence to recommend a CDR. In others, we have only preliminary evidence that needs testing in future studies. Most findings were tested in secondary or tertiary care. Thus, the accuracy of the findings in a primary care setting has yet to be confirmed.

Droplet digital PCR-based EGFR mutation detection with an internal quality control index to determine the quality of DNA.

PubMed

Kim, Sung-Su; Choi, Hyun-Jeung; Kim, Jin Ju; Kim, M Sun; Lee, In-Seon; Byun, Bohyun; Jia, Lina; Oh, Myung Ryurl; Moon, Youngho; Park, Sarah; Choi, Joon-Seok; Chae, Seoung Wan; Nam, Byung-Ho; Kim, Jin-Soo; Kim, Jihun; Min, Byung Soh; Lee, Jae Seok; Won, Jae-Kyung; Cho, Soo Youn; Choi, Yoon-La; Shin, Young Kee

2018-01-11

In clinical translational research and molecular in vitro diagnostics, a major challenge in the detection of genetic mutations is overcoming artefactual results caused by the low-quality of formalin-fixed paraffin-embedded tissue (FFPET)-derived DNA (FFPET-DNA). Here, we propose the use of an 'internal quality control (iQC) index' as a criterion for judging the minimum quality of DNA for PCR-based analyses. In a pre-clinical study comparing the results from droplet digital PCR-based EGFR mutation test (ddEGFR test) and qPCR-based EGFR mutation test (cobas EGFR test), iQC index ≥ 0.5 (iQC copies ≥ 500, using 3.3 ng of FFPET-DNA [1,000 genome equivalents]) was established, indicating that more than half of the input DNA was amplifiable. Using this criterion, we conducted a retrospective comparative clinical study of the ddEGFR and cobas EGFR tests for the detection of EGFR mutations in non-small cell lung cancer (NSCLC) FFPET-DNA samples. Compared with the cobas EGFR test, the ddEGFR test exhibited superior analytical performance and equivalent or higher clinical performance. Furthermore, iQC index is a reliable indicator of the quality of FFPET-DNA and could be used to prevent incorrect diagnoses arising from low-quality samples.

Muscular exercise can cause highly pathological liver function tests in healthy men.

PubMed

Pettersson, Jonas; Hindorf, Ulf; Persson, Paula; Bengtsson, Thomas; Malmqvist, Ulf; Werkström, Viktoria; Ekelund, Mats

2008-02-01

The occurrence of idiosyncratic drug hepatotoxicity is a major problem in all phases of clinical drug development and the leading cause of postmarketing warnings and withdrawals. Physical exercise can result in transient elevations of liver function tests. There is no consensus in the literature on which forms of exercise may cause changes in liver function tests and to what extent. Weightlifting results in profound increases in liver function tests in healthy men used to moderate physical activity, not including weightlifting. Liver function tests are significantly increased for at least 7 days after weightlifting. It is important to impose relevant restrictions on heavy muscular exercise prior to and during clinical studies. To investigate the effect of intensive muscular exercise (weightlifting) on clinical chemistry parameters reflecting liver function in healthy men. Fifteen healthy men, used to moderate physical activity not including weightlifting, performed an 1 h long weightlifting programme. Blood was sampled for clinical chemistry parameters [aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LD), gamma-glutamyl transferase (gamma GT), alkaline phosphatase (ALP), bilirubin, creatine kinase (CK) and myoglobin] at repeated intervals during 7 days postexercise and at a follow-up examination 10-12 days postexercise. Five out of eight studied clinical chemistry parameters (AST, ALT, LD, CK and myoglobin) increased significantly after exercise (P < 0.01) and remained increased for at least 7 days postexercise. Bilirubin, gamma GT and ALP remained within the normal range. The liver function parameters, AST and ALT, were significantly increased for at least 7 days after the exercise. In addition, LD and, in particular, CK and myoglobin showed highly elevated levels. These findings highlight the importance of imposing restrictions on weightlifting prior to and during clinical studies. Intensive muscular exercise, e.g. weightlifting, should also be considered as a cause of asymptomatic elevations of liver function tests in daily clinical practice.

Intraoperatively Testing the Anastomotic Integrity of Esophagojejunostomy Using Methylene Blue.

PubMed

Celik, S; Almalı, N; Aras, A; Yılmaz, Ö; Kızıltan, R

2017-03-01

Intraoperative testing of gastrointestinal anastomosis effectively ensures anastomotic integrity. This study investigated whether the routine use of methylene blue intraoperatively identified leaks to reduce the postoperative proportion of clinical leaks. This study retrospectively analyzed consecutive total gastrectomies performed from January 2007 to December 2014 in a university hospital setting by a general surgical group that exclusively used the methylene blue test. All surgeries were performed for gastric or junctional cancers (n = 198). All reconstructions (Roux-en Y esophagojejunostomy) were performed using a stapler. The methylene blue test was used in 108 cases (group 1) via a nasojejunal tube. No test was performed for the other 90 cases (group 2). Intraoperative leakage rate, postoperative clinical leakage rate, length of hospitalization, and mortality rate were the outcome measures. The intraoperative leakage rate was 7.4% in group 1. The postoperative clinical leakage rate was 8.6%. The postoperative clinical leakage rate was 3.7% in group 1 and 14.4% in group 2 (p = 0.007). There were no postoperative clinical leaks when an intraoperative leak led to concomitant intraoperative repair. The median length of hospital stay was 6 days in group 1 and 8 days in group 2 (p < 0.001). One death occurred in each group. No test-related complications were observed. The methylene blue test for esophagojejunostomy is a safe and reliable method for the assessment of anastomosis integrity, especially in cases with difficult esophagojejunostomic construction.

Discordance of physician clinical judgment vs. pneumonia severity index (PSI) score to admit patients with low risk community-acquired pneumonia: a prospective multicenter study.

PubMed

Marcos, Pedro J; Restrepo, Marcos I; González-Barcala, Francisco J; Soni, Nilam J; Vidal, Iria; Sanjuàn, Pilar; Llinares, Diego; Ferreira-Gonzalez, Lucía; Rábade, Carlos; Otero-González, Isabel; Marcos, Pedro; Verea-Hernando, Héctor

2017-06-01

The relationship between clinical judgment and the pneumonia severity index (PSI) score in deciding the site of care for patients with community-acquired pneumonia (CAP) has not been well investigated. The objective of the study was to determine the clinical factors that influence decision-making to hospitalize low-risk patients (PSI ≤2) with CAP. An observational, prospective, multicenter study of consecutive CAP patients was performed at five hospitals in Spain. Patients admitted with CAP and a PSI ≤2 were identified. Admitting physicians completed a patient-specific survey to identify the clinical factors influencing the decision to admit a patient. The reason for admission was categorized into 1 of 6 categories. We also assessed whether the reason for admission was associated with poorer clinical outcomes [intensive care unit (ICU) admission, 30-day mortality or readmission]. One hundred and fifty-five hospitalized patients were enrolled. Two or more reasons for admission were seen in 94 patients (60.6%), including abnormal clinical test results (60%), signs of clinical deterioration (43.2%), comorbid conditions (28.4%), psychosocial factors (28.4%), suspected H1N1 pneumonia (20.6%), and recent visit to the emergency department (ED) in the past 2 weeks (7.7%). Signs of clinical deterioration and abnormal clinical test results were associated with poorer clinical outcomes (P<0.005). Low-risk patients with CAP and a PSI ≤2 are admitted to the hospital for multiple reasons. Abnormal clinical test results and signs of clinical deterioration are two specific reasons for admission that are associated with poorer clinical outcomes in low risk CAP patients.

No Clinically Significant Difference Between Adult and Pediatric IKDC Subjective Knee Evaluation Scores in Adults

PubMed Central

Stegmeier, Nicole; Oak, Sameer R.; O’Rourke, Colin; Strnad, Greg; Spindler, Kurt P.; Jones, Morgan; Farrow, Lutul D.; Andrish, Jack; Saluan, Paul

2017-01-01

Background: Two versions of the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation form currently exist: the original version (1999) and a recently modified pediatric-specific version (2011). Comparison of the pediatric IKDC with the adult version in the adult population may reveal that either version could be used longitudinally. Hypothesis: We hypothesize that the scores for the adult IKDC and pediatric IKDC will not be clinically different among adult patients aged 18 to 50 years. Study Design: Randomized crossover study design. Level of Evidence: Level 2. Methods: The study consisted of 100 participants, aged 18 to 50 years, who presented to orthopaedic outpatient clinics with knee problems. All participants completed both adult and pediatric versions of the IKDC in random order with a 10-minute break in between. We used a paired t test to test for a difference between the scores and a Welch’s 2-sample t test to test for equivalence. A least-squares regression model was used to model adult scores as a function of pediatric scores, and vice versa. Results: A paired t test revealed a statistically significant 1.6-point difference between the mean adult and pediatric scores. However, the 95% confidence interval (0.54-2.66) for this difference did not exceed our a priori threshold of 5 points, indicating that this difference was not clinically important. Equivalence testing with an equivalence region of 5 points further supported this finding. The adult and pediatric scores had a linear relationship and were highly correlated with an R2 of 92.6%. Conclusion: There is no clinically relevant difference between the scores of the adult and pediatric IKDC forms in adults, aged 18 to 50 years, with knee conditions. Clinical Relevance: Either form, adult or pediatric, of the IKDC can be used in this population for longitudinal studies. If the pediatric version is administered in adolescence, it can be used for follow-up into adulthood. PMID:28080306

Knowledge and Practices of Toxoplasmosis among Clinical Laboratory Professionals: A Cross-Sectional Study in Durango, Mexico.

PubMed

Alvarado-Esquivel, Cosme; Sánchez-Anguiano, Luis Francisco; Berumen-Segovia, Luis Omar; Hernández-Tinoco, Jesús; Rico-Almochantaf, Yazmin Del Rosario; Cisneros-Camacho, Alfredo; Cisneros-Martínez, Jorge Arturo

2017-11-18

Background : The aim of this study was to determine the level of knowledge and practices about toxoplasmosis in a sample of clinical laboratory professionals in Mexico. Methods : 192 clinical laboratory professionals were surveyed. They were asked about (1) Toxoplasma gondii ; (2) clinical manifestations, diagnosis, treatment, and epidemiology of toxoplasmosis; and (3) their practices with respect to toxoplasmosis. Results : The range of animals infected by T. gondii was known by 44.8% of participants. Clinical aspects of toxoplasmosis were known by up to 44.3% of subjects. Correct answers about the interpretation of serological markers of T. gondii infection were provided by up to 32.8% of participants. A minority (32.2%) of participants knew about a high number of false positive results of anti- T. gondii IgM antibody tests. Most participants (90.1%) did not know what the anti- T. gondii IgG avidity test was. Up to 55.7% of participants provided incorrect answers about the interpretation of serology tests for the treatment of pregnant women. Common routes of T. gondii infection were known by <15% of participants. Most (84.4%) participants had not performed tests for detection T. gondii infection. Conclusions : Results indicate incomplete knowledge of T. gondii infection and toxoplasmosis and a limited practice of laboratory tests among the professionals surveyed.

Influence networks among substance abuse treatment clinics: implications for the dissemination of innovations.

PubMed

Johnson, Kimberly; Quanbeck, Andrew; Maus, Adam; Gustafson, David H; Dearing, James W

2015-09-01

Understanding influence networks among substance abuse treatment clinics may speed the diffusion of innovations. The purpose of this study was to describe influence networks in Massachusetts, Michigan, New York, Oregon, and Washington and test two expectations, using social network analysis: (1) Social network measures can identify influential clinics; and (2) Within a network, some weakly connected clinics access out-of-network sources of innovative evidence-based practices and can spread these innovations through the network. A survey of 201 clinics in a parent study on quality improvement provided the data. Network measures and sociograms were obtained from adjacency matrixes created by UCINet. We used regression analysis to determine whether network status relates to clinics' adopting innovations. Findings suggest that influential clinics can be identified and that loosely linked clinics were likely to join the study sooner than more influential clinics but were not more likely to have improved outcomes than other organizations. Findings identify the structure of influence networks for SUD treatment organizations and have mixed results on how those structures impacted diffusion of the intervention under study. Further study is necessary to test whether use of knowledge of the network structure will have an effect on the pace and breadth of dissemination of innovations.

76 FR 33303 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-08

... comments should be received within 60 days of this notice. Proposed Project Survey of Rapid Influenza... Description The Survey of Rapid Influenza Diagnostic Testing Practices in Clinical Laboratories is a national systematic study investigating rapid influenza diagnostic testing practices in clinical [[Page 33304...

The Role of In Vitro Susceptibility Testing in the Management of Candida and Aspergillus.

PubMed

Ostrosky-Zeichner, Luis; Andes, David

2017-08-15

Antifungal susceptibility testing has evolved from a research technique to a standardized and well-validated tool for the clinical management of fungal infections and for epidemiological studies. Genetic mutations and phenotypic resistance in vitro have been shown to correlate with clinical outcomes and treatment failures, and this in turn has led to the creation of clinical breakpoints and, more recently, epidemiological cutoff values for clinically relevant fungal pathogens. Resistance mechanisms for Candida and Aspergillus species have been extensively described and their corresponding genetic mutations can now be readily detected. Epidemiological studies have been able to detect the emergence of regional clonal and nonclonal resistance in several countries. The clinical microbiology laboratory is expected to transition from culture and traditional susceptibility testing to molecular methods for detection, identification, and resistance profiling over the next 5-10 years. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Clinical and electrophysiologic attributes as predictors of results of autonomic function tests

NASA Technical Reports Server (NTRS)

Wu, C. L.; Denq, J. C.; Harper, C. M.; O'Brien, P. C.; Low, P. A.

1998-01-01

Autonomic dysfunction is a feature of some neuropathies and not others. It has been suggested that some clinical and electrophysiologic attributes are predictable of autonomic impairment detected using laboratory testing; however, dear guidelines are unavailable. We evaluated 138 relatively unselected patients with peripheral neuropathy who underwent neurologic evaluation, electromyography (EMG), nerve conduction studies, and autonomic function tests to determine which variables were predictive of laboratory findings of autonomic failure. The variables evaluated were 1) clinical somatic neuropathic findings, 2) clinical autonomic symptoms, and 3) electrophysiologic findings. Autonomic symptoms were strongly predictive (Rs = 0.40, p < 0.001) of autonomic failure. Among the non-autonomic indices, absent ankle reflexes were mildly predictive (Rs = 0.19, p = 0.022) of autonomic impairment, but all others were not (duration, clinical pattern, severity, weakness, sensory loss). Electrophysiologic changes of an axonal neuropathy predicted autonomic impairment while demyelinating neuropathy did not. We conclude that autonomic studies will most likely be abnormal in patients who have symptoms of autonomic involvement and those who have an axonal neuropathy.

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.

PubMed

Koren, Eugen; Smith, Holly W; Shores, Elizabeth; Shankar, Gopi; Finco-Kent, Deborah; Rup, Bonita; Barrett, Yu-Chen; Devanarayan, Viswanath; Gorovits, Boris; Gupta, Shalini; Parish, Thomas; Quarmby, Valerie; Moxness, Michael; Swanson, Steven J; Taniguchi, Gary; Zuckerman, Linda A; Stebbins, Christopher C; Mire-Sluis, Anthony

2008-04-20

The appropriate evaluation of the immunogenicity of biopharmaceuticals is of major importance for their successful development and licensure. Antibodies elicited by these products in many cases cause no detectable clinical effects in humans. However, antibodies to some therapeutic proteins have been shown to cause a variety of clinical consequences ranging from relatively mild to serious adverse events. In addition, antibodies can affect drug efficacy. In non-clinical studies, anti-drug antibodies (ADA) can complicate interpretation of the toxicity, pharmacokinetic (PK) and pharmacodynamic (PD) data. Therefore, it is important to develop testing strategies that provide valid assessments of antibody responses in both non-clinical and clinical studies. This document provides recommendations for antibody testing strategies stemming from the experience of contributing authors. The recommendations are intended to foster a more unified approach to antibody testing across the biopharmaceutical industry. The strategies proposed are also expected to contribute to better understanding of antibody responses and to further advance immunogenicity evaluation.

Neurocognitive function in clinically stable individuals with long-term bipolar I disorder: Comparisons with schizophrenia patients and controls.

PubMed

Lin, Pei-Yun; Wang, Peng-Wei; Chen, Cheng-Sheng; Yen, Cheng-Fang

2017-05-01

This study compared the levels of the five domains of neurocognitive function-executive function, attention, memory, verbal comprehension, and perceptual organization-among clinically stable individuals with long-term bipolar I disorder, individuals with long-term schizophrenia, and a group of controls. We recruited a total of 93 clinically stable individuals with bipolar I disorder, 94 individuals with schizophrenia, and 106 controls in this study. Their neurocognitive function was measured using a series of neurocognitive function tests: the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III), Line Cancellation Test, Visual Form Discrimination, Controlled Oral Word Association Test, Wisconsin Card Sorting Test, Continuous Performance Task, and Wechsler Memory Scale-Third Edition. Neurocognitive function was compared among the three groups through a multivariate analysis of variance. The results indicated that when the effect of age was controlled, clinically stable individuals with bipolar I disorder and those with schizophrenia demonstrated poor neurocognitive function on all tests except for the WAIS-III Similarity and Information and the Line Cancellation Test. The individuals with bipolar I disorder had similar levels of neurocognitive function compared with the schizophrenia group, but higher levels of neurocognitive function on the WAIS-III Comprehension, Controlled Oral Word Association Test, and Wechsler Memory Scale-Third Edition Auditory Immediate and Delayed Index and Visual Immediate and Delayed Index. The conclusions of this study suggest that compared with controls, individuals with long-term bipolar I disorder and those with long-term schizophrenia have poorer neurocognitive function, even when clinically stable. Individuals with long-term bipolar I disorder and those with long-term schizophrenia have similar levels of deficits in several domains of neurocognitive function. Copyright © 2017. Published by Elsevier Taiwan.

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

Prostate Cancer Screening

MedlinePlus

... decrease the risk of dying from cancer. Scientists study screening tests to find those with the fewest risks and ... or routine screening test for prostate cancer. Screening tests for prostate cancer are under study, and there are screening clinical trials taking place ...

Toxoplasma gondii seroprevalence and association with equine protozoal myeloencephalitis: A case-control study of Californian horses.

PubMed

James, K E; Smith, W A; Packham, A E; Conrad, P A; Pusterla, N

2017-06-01

While toxoplasmosis is not commonly considered a clinical disease of equines, previous seroprevalence studies have reported differing background rates of Toxoplasma gondii infection in horses globally. The objective of this study was to evaluate possible associations between T. gondii seroprevalence and clinical signs of equine protozoal myeloencephalitis (EPM) in horses. Using a case-control study design, 720 Californian horses with neurologic signs compatible with EPM were compared to healthy, non-neurologic horses for the presence of T. gondii antibodies (using indirect fluorescent antibody tests [IFAT]). Toxoplasma gondii seroprevalence among cases and controls was determined at standard serum cut-offs: 40, 80, 160, 320, and 640. At a T. gondii titre cut-off of 320, horses with clinical signs compatible with EPM had 3.55 times the odds of a seropositive test compared to those without clinical signs (P<0.01) when adjusted for covariates. When restricted to the autumn season and at the same titre cut-off, an EPM suspect horse had 6.4 times the odds of testing seropositive to T. gondii, compared to non-neurologic horses. The association between high T. gondii titres and clinical signs compatible with EPM is potentially reflective of toxoplasmosis in equines. Serologic testing of cerebrospinal fluid and isolation of T. gondii in EPM suspect cases should be considered. Future studies investigating the relationship between T. gondii and EPM are warranted. Copyright © 2017 Elsevier Ltd. All rights reserved.

Management of Chronic Periodontitis Using Subgingival Irrigation of Ozonized Water: A Clinical and Microbiological Study

PubMed Central

Mathew, Jayan Jacob; Ambooken, Majo; Kachappilly, Arun Jose; PK, Ajithkumar; Johny, Thomas; VK, Linith; Samuel, Anju

2015-01-01

Introduction Adjunctive use of professional subgingival irrigation with scaling and root planing (SRP) has been found to be beneficial in eradicating the residual microorganisms in the pocket. Objective To evaluate the effect of ozonized water subgingival irrigation on microbiologic parameters and clinical parameters namely Gingival index, probing pocket depth, and clinical attachment level. Materials and Methods Thirty chronic periodontitis patients with probing pocket depth ≥6mm on at least one tooth on contra lateral sides of opposite arches were included in the study. The test sites were subjected to ozonized water subgingival irrigation with subgingival irrigation device fitted with a modified subgingival tip. Control sites were subjected to scaling and root planing only. The following clinical parameters were recorded initially and after 4 weeks at the test sites and control sites. Plaque Index, Gingival Index, probing pocket depth, clinical attachment level. Microbiologic sampling was done for the test at the baseline, after scaling, immediately after ozonized water subgingival irrigation and after 4 weeks. In control sites microbiologic sampling was done at the baseline, after scaling and after 4 weeks. The following observations were made after 4 weeks. The results were statistically analysed using independent t-test and paired t-test. Result Test sites showed a greater reduction in pocket depth and gain in clinical attachment compared to control sites. The total anaerobic counts were significantly reduced by ozonized water subgingival irrigation along with SRP compared to SRP alone. Conclusion Ozonized water subgingival irrigation can improve the clinical and microbiological parameters in patients with chronic periodontitis when used as an adjunct to scaling and root planing. PMID:26436042

Usability Testing of a National Substance Use Screening Tool Embedded in Electronic Health Records.

PubMed

Press, Anne; DeStio, Catherine; McCullagh, Lauren; Kapoor, Sandeep; Morley, Jeanne; Conigliaro, Joseph

2016-07-08

Screening, brief intervention, and referral to treatment (SBIRT) is currently being implemented into health systems nationally via paper and electronic methods. The purpose of this study was to evaluate the integration of an electronic SBIRT tool into an existing paper-based SBIRT clinical workflow in a patient-centered medical home. Usability testing was conducted in an academic ambulatory clinic. Two rounds of usability testing were done with medical office assistants (MOAs) using a paper and electronic version of the SBIRT tool, with two and four participants, respectively. Qualitative and quantitative data was analyzed to determine the impact of both tools on clinical workflow. A second round of usability testing was done with the revised electronic version and compared with the first version. Personal workflow barriers cited in the first round of testing were that the electronic health record (EHR) tool was disruptive to patient's visits. In Round 2 of testing, MOAs reported favoring the electronic version due to improved layout and the inclusion of an alert system embedded in the EHR. For example, using the system usability scale (SUS), MOAs reported a grade "1" for the statement, "I would like to use this system frequently" during the first round of testing but a "5" during the second round of analysis. The importance of testing usability of various mediums of tools used in health care screening is highlighted by the findings of this study. In the first round of testing, the electronic tool was reported as less user friendly, being difficult to navigate, and time consuming. Many issues faced in the first generation of the tool were improved in the second generation after usability was evaluated. This study demonstrates how usability testing of an electronic SBRIT tool can help to identify challenges that can impact clinical workflow. However, a limitation of this study was the small sample size of MOAs that participated. The results may have been biased to Northwell Health workers' perceptions of the SBIRT tool and their specific clinical workflow.

Demystifying the Clinical Diagnosis of Greater Trochanteric Pain Syndrome in Women.

PubMed

Ganderton, Charlotte; Semciw, Adam; Cook, Jill; Pizzari, Tania

2017-06-01

To evaluate the diagnostic accuracy of 10 clinical tests that can be used in the diagnosis of greater trochanteric pain syndrome (GTPS) in women, and to compare these clinical tests to magnetic resonance imaging (MRI) findings. Twenty-eight participants with GTPS (49.5 ± 22.0 years) and 18 asymptomatic participants (mean age ± standard deviation [SD], 52.5 ± 22.8 years) were included. A blinded physiotherapist performed 10 pain provocation tests potentially diagnostic for GTPS-palpation of the greater trochanter, resisted external derotation test, modified resisted external derotation test, standard and modified Ober's tests, Patrick's or FABER test, resisted hip abduction, single-leg stance test, and the resisted hip internal rotation test. A sample of 16 symptomatic and 17 asymptomatic women undertook a hip MRI scan. Gluteal tendons were evaluated and categorized as no pathology, mild tendinosis, moderate tendinosis/partial tear, or full-thickness tear. Clinical test analyses show high specificity, high positive predictive value, low to moderate sensitivity, and negative predictive value for most clinical tests. All symptomatic and 88% of asymptomatic participants had pathological gluteal tendon changes on MRI, from mild tendinosis to full-thickness tear. The study found the Patrick's or FABER test, palpation of the greater trochanter, resisted hip abduction, and the resisted external derotation test to have the highest diagnostic test accuracy for GTPS. Tendon pathology on MRI is seen in both symptomatic and asymptomatic women.

Illustrating idiographic methods for translation research: moderation effects, natural clinical experiments, and complex treatment-by-subgroup interactions.

PubMed

Ridenour, Ty A; Wittenborn, Andrea K; Raiff, Bethany R; Benedict, Neal; Kane-Gill, Sandra

2016-03-01

A critical juncture in translation research involves the preliminary studies of intervention tools, provider training programs, policies, and other mechanisms used to leverage knowledge garnered at one translation stage into another stage. Potentially useful for such studies are rigorous techniques for conducting within-subject clinical trials, which have advanced incrementally over the last decade. However, these methods have largely not been utilized within prevention or translation contexts. The purpose of this manuscript is to demonstrate the flexibility, wide applicability, and rigor of idiographic clinical trials for preliminary testing of intervention mechanisms. Specifically demonstrated are novel uses of state-space modeling for testing intervention mechanisms of short-term outcomes, identifying heterogeneity in and moderation of within-person treatment mechanisms, a horizontal line plot to refine sampling design during the course of a clinic-based experimental study, and the need to test a treatment's efficacy as treatment is administered along with (e.g., traditional 12-month outcomes).

[The antibacterial activity of oregano essential oil (Origanum heracleoticum L.) against clinical strains of Escherichia coli and Pseudomonas aeruginosa].

PubMed

Sienkiewicz, Monika; Wasiela, Małgorzata; Głowacka, Anna

2012-01-01

The aim of this study was to investigate the antibacterial properties of oregano (Origanum heracleoticum L.) essential oil against clinical strains of Escherichia coli and Pseudomonas aeruginosa. The antibacterial activity of oregano essential oil was investigate against 2 tested and 20 clinical bacterial strains of Escherichia coli and 20 clinical strains o Pseudomonas aeruginosa come from patients with different clinical conditions. The agar dilution method was used for microbial growth inhibition at various concentrations ofoil. Susceptibility testing to antibiotics was carried out using disc-diffusion method. The results of experiments showed that the tested oil was active against all of the clinical strains from both genus of bacteria, but strains of Escherichia coli were more sensitive to tested oil. Essential oil from Origanum heracleoticum L. inhibited the growth of Escherichia coli and Pseudomonas aeruginosa clinical strains with different patters of resistance. The obtained outcomes will enable further investigations using oregano essential oil obtained from Origanum heracleoticum L. as alternative antibacterial remedies enhancing healing process in bacterial infections and as an effective means for the prevention of antibiotic-resistant strain development.

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

Indirect zirconia-reinforced lithium silicate ceramic CAD/CAM restorations: Preliminary clinical results after 12 months.

PubMed

Zimmermann, Moritz; Koller, Christina; Mehl, Albert; Hickel, Reinhard

2017-01-01

No clinical data are available for the new computer-aided design/computer-assisted manufacture (CAD/CAM) material zirconia-reinforced lithium silicate (ZLS) ceramic. This study describes preliminary clinical results for indirect ZLS CAD/CAM restorations after 12 months. Indirect restorations were fabricated, using the CEREC method and intraoral scanning (CEREC Omnicam, CEREC MCXL). Sixty-seven restorations were seated adhesively (baseline). Sixty restorations were evaluated after 12 months (follow-up), using modified FDI criteria. Two groups were established, according to ZLS restorations' post-processing procedure prior to adhesive seating: group I (three-step polishing, n = 32) and group II (fire glazing, n = 28). Statistical analysis was performed with Mann-Whitney U test and Wilcoxon test (P < .05). The success rate of indirect ZLS CAD/CAM restorations after 12 months was 96.7%. Two restorations clinically failed as a result of bulk fracture (failure rate 3.3%). No statistically significant differences were found for baseline and follow-up criteria (Wilcoxon test, P > .05). Statistically significant differences were found for criteria surface gloss for group I and group II (Mann-Whitney U test, P < .05). This study demonstrates ZLS CAD/CAM restorations have a high clinical success rate after 12 months. A longer clinical evaluation period is necessary to draw further conclusions.

Toward a clinical practice guide in pharmacogenomics testing for functional polymorphisms of drug-metabolizing enzymes. Gene/drug pairs and barriers perceived in Spain

PubMed Central

Agúndez, José A. G.; Abad-Santos, Francisco; Aldea, Ana; Alonso-Navarro, Hortensia; Bernal, María L.; Borobia, Alberto M.; Borrás, Emma; Carballo, Miguel; Carvajal, Alfonso; García-Muñiz, José D.; Gervasini, Guillermo; Jiménez-Jiménez, Félix J.; Lucena, María I.; Martínez, Carmen; Sacristán, José A.; Salado, Inés; Sinués, Blanca; Vicente, Jorge; García-Martín, Elena

2012-01-01

The development of clinical practice recommendations or guidelines for the clinical use of biomarkers is an issue of great importance with regard to adverse drug reactions. The potential of pharmacogenomic biomarkers has been extensively investigated in recent years. However, several barriers to implementing the use of pharmacogenomics testing exist. We conducted a survey among members of the Spanish Societies of Pharmacology and Clinical Pharmacology to obtain information about the perception of such barriers and to compare the perceptions of participants about the relative importance of major gene/drug pairs. Of 11 potential barriers, the highest importance was attributed to lack of institutional support for pharmacogenomics testing, and to the issues related to the lack of guidelines. Of the proposed gene/drug pairs the highest importance was assigned to HLA-B/abacavir, UGT1A1/irinotecan, and CYP2D6/tamoxifen. In this perspective article, we compare the relative importance of 29 gene/drug pairs in the Spanish study with that of the same pairs in the American Society for Clinical Pharmacology and Therapeutics study, and we provide suggestions and areas of focus to develop a guide for clinical practice in pharmacogenomics testing. PMID:23233861

Does It Matter if You "Kill" the Patient or Order Too Many Tests? Scoring Alternatives for a Test of Clinical Reasoning Skill

ERIC Educational Resources Information Center

Childs, Ruth A.; Dunn, Jennifer L.; van Barneveld, Christina; Jaciw, Andrew P.

2007-01-01

This study compares five scoring approaches for a test of clinical reasoning skills. All of the approaches incorporate information about the correct item responses selected and the errors, such as selecting too many responses or selecting a response that is inappropriate and/or harmful to the patient. The approaches are combinations of theoretical…

Scleroderma Research Foundation

MedlinePlus

... with suspected lung hypertension. Scleroderma Patients Needed for Research Study to Evaluate Internet Self-Management Program January-2017 ... year before a standard clinical test could. Clinical Research Study for Scleroderma with Interstitial Lung Disease (lung scarring) ...

Expertise in Clinical Psychology. The Effects of University Training and Practical Experience on Expertise in Clinical Psychology

PubMed Central

Vollmer, Sabine; Spada, Hans; Caspar, Franz; Burri, Salome

2013-01-01

How do university training and subsequent practical experience affect expertise in clinical psychology? To answer this question we developed methods to assess psychological knowledge and the competence to diagnose, construct case conceptualizations, and plan psychotherapeutic treatment: a knowledge test and short case studies in a first study, and a complex, dynamically evolving case study in the second study. In our cross-sectional studies, psychology students, trainees in a certified postgraduate psychotherapist curriculum, and behavior therapists with more than 10 years of experience were tested (100 in total: 20 each of novice, intermediate, and advanced university students, postgraduate trainees, and therapists). Clinical knowledge and competence increased up to the level of trainees but unexpectedly decreased at the level of experienced therapists. We discuss the results against the background of expertise research and the training of clinical psychologists (in Germany). Important factors for the continuing professional development of psychotherapists are proposed. PMID:23543213

Improving the quality of cognitive screening assessments: ACEmobile, an iPad-based version of the Addenbrooke's Cognitive Examination-III.

PubMed

Newman, Craig G J; Bevins, Adam D; Zajicek, John P; Hodges, John R; Vuillermoz, Emil; Dickenson, Jennifer M; Kelly, Denise S; Brown, Simona; Noad, Rupert F

2018-01-01

Ensuring reliable administration and reporting of cognitive screening tests are fundamental in establishing good clinical practice and research. This study captured the rate and type of errors in clinical practice, using the Addenbrooke's Cognitive Examination-III (ACE-III), and then the reduction in error rate using a computerized alternative, the ACEmobile app. In study 1, we evaluated ACE-III assessments completed in National Health Service (NHS) clinics ( n  = 87) for administrator error. In study 2, ACEmobile and ACE-III were then evaluated for their ability to capture accurate measurement. In study 1, 78% of clinically administered ACE-IIIs were either scored incorrectly or had arithmetical errors. In study 2, error rates seen in the ACE-III were reduced by 85%-93% using ACEmobile. Error rates are ubiquitous in routine clinical use of cognitive screening tests and the ACE-III. ACEmobile provides a framework for supporting reduced administration, scoring, and arithmetical error during cognitive screening.

Deciphering Sources of Variability in Clinical Pathology.

PubMed

Tripathi, Niraj K; Everds, Nancy E; Schultze, A Eric; Irizarry, Armando R; Hall, Robert L; Provencher, Anne; Aulbach, Adam

2017-01-01

The objectives of this session were to explore causes of variability in clinical pathology data due to preanalytical and analytical variables as well as study design and other procedures that occur in toxicity testing studies. The presenters highlighted challenges associated with such variability in differentiating test article-related effects from the effects of experimental procedures and its impact on overall data interpretation. These presentations focused on preanalytical and analytical variables and study design-related factors and their influence on clinical pathology data, and the importance of various factors that influence data interpretation including statistical analysis and reference intervals. Overall, these presentations touched upon potential effect of many variables on clinical pathology parameters, including animal physiology, sample collection process, specimen handling and analysis, study design, and some discussion points on how to manage those variables to ensure accurate interpretation of clinical pathology data in toxicity studies. This article is a brief synopsis of presentations given in a session entitled "Deciphering Sources of Variability in Clinical Pathology-It's Not Just about the Numbers" that occurred at the 35th Annual Symposium of the Society of Toxicologic Pathology in San Diego, California.

Detection of fetal sex chromosome aneuploidy by massively parallel sequencing of maternal plasma DNA: initial experience in a Chinese hospital.

PubMed

Yao, H; Jiang, F; Hu, H; Gao, Y; Zhu, Z; Zhang, H; Wang, Y; Guo, Y; Liu, L; Yuan, Y; Zhou, L; Wang, J; Du, B; Qu, N; Zhang, R; Dong, Y; Xu, H; Chen, F; Jiang, H; Liu, Y; Zhang, L; Tian, Z; Liu, Q; Zhang, C; Pan, X; Yang, S; Zhao, L; Wang, W; Liang, Z

2014-07-01

To evaluate the performance of a massively parallel sequencing (MPS)-based test in detecting fetal sex chromosome aneuploidy (SCA) and to present a comprehensive clinical counseling protocol for SCA-positive patients. This was a retrospective study in a large patient cohort of 5950 singleton pregnancies which underwent MPS-based testing as a prenatal screening test for trisomies 21, 18 and 13, with X and Y chromosomes as secondary findings, in Southwest Hospital in China. MPS-based SCA-positive women were offered the choice of knowing whether their SCA results were positive and those who did commenced a two-stage post-test clinical counseling protocol. In Stage 1, general information about SCA was given, and women were given the option of invasive testing for confirmation of findings; in Stage 2, those who had chosen to undergo invasive testing were informed about the specific SCA affecting their fetus and their management options. Thirty-three cases were classified as SCA-positive by MPS-based testing. After Stage 1 of the two-stage post-test clinical counseling session, 33 (100%) of these pregnant women chose to know the screening test results, and 25 (75.76%) underwent an invasive diagnostic procedure and karyotype analysis, in one of whom karyotyping failed. In thirteen cases, karyotyping confirmed the MPS-based test results (two X0 cases, seven XXX cases, three XXY cases and one XYY case), giving a positive predictive value of 54.17% (13/24 cases confirmed by karyotyping). After post-test clinical counseling session Stage 2, seven women chose to terminate the pregnancy: one X0 case, two XXX cases, the three XXY cases and the single XYY case. Six women decided to continue with pregnancy: one X0 case and five XXX cases. Our study showed the feasibility of clinical application of the MPS-based test in the non-invasive detection of fetal SCA. Together with a two-stage post-test clinical counseling protocol, it leads to a well-informed decision-making procedure. Copyright © 2014 ISUOG. Published by John Wiley & Sons Ltd.

Effect of cooling of cooked white rice on resistant starch content and glycemic response.

PubMed

Sonia, Steffi; Witjaksono, Fiastuti; Ridwan, Rahmawati

2015-01-01

Cooling of cooked starch is known to cause starch retrogradation which increases resistant starch content. This study aimed to determine the effect of cooling of cooked white rice on resistant starch content and glycemic response in healthy subjects. Resistant starch contents were analyzed on freshly cooked white rice (control rice), cooked white rice cooled for 10 hours at room temperature (test rice I), and cooked white rice cooled for 24 hours at 4°C then reheated (test rice II). The results showed that resistant starch contents in control rice, test rice I, and test rice II were 0.64 g/100 g, 1.30 g/100 g, and 1.65 g/100 g, respectively. Test rice II had higher resistant starch content than test rice I, hence used in the clinical study along with control rice to characterize glycemic response in 15 healthy adults. The clinical study was a randomized, single-blind crossover study. In the clinical study, test rice II significantly lowered glycemic response compared with control rice (125±50.1 vs 152±48.3 mmol.min/L, respectively; p=0.047). In conclusion, cooling of cooked white rice increased resistant starch content. Cooked white rice cooled for 24 hours at 4°C then reheated lowered glycemic response compared with freshly cooked white rice.

Ranitidine-induced anaphylaxis: clinical features, cross-reactivity, and skin testing.

PubMed

Park, K H; Pai, J; Song, D-G; Sim, D W; Park, H J; Lee, J-H; Jeong, K Y; Pan, C-H; Shin, I; Park, J-W

2016-04-01

Histamine H2 receptor antagonists are commonly prescribed medications and are known to be well tolerated. However, 99 cases of ranitidine-induced anaphylaxis occurred in Korea from 2007 to 2014. The purpose of this study was to determine the incidence, clinical features, and diagnostic methods for ranitidine-induced anaphylaxis. Ranitidine-related pharmacovigilance data from 2007 to 2014 were reviewed. Adverse drug reactions with causal relationships were selected, and clinical manifestations, outcomes, and drug-related information were assessed. For further investigation, 8 years of pharmacovigilance data were collected at a single centre. Twenty-three patients participated in in vivo and in vitro studies. Skin tests, oral provocation tests, and laboratory tests were performed, including tests using other kinds of histamine H2 receptor antagonists. Over 7 years, 584 patients suffered adverse reactions to ranitidine. The most common manifestation was cutaneous symptoms. Among them, 99 patients (17.0%) experienced anaphylaxis. In a single-centre study, skin prick tests were positive in 91.7% of ranitidine-induced anaphylaxis patients (11/12); the optimal concentration was 20 mg/mL. Detection of ranitidine-specific immunoglobulin E failed. Cimetidine and proton pump inhibitors showed no cross-reactivity with ranitidine based on the skin prick test, oral provocation test, or clinical determination. Surprisingly, 82.6% of patients reintroduced ranitidine and re-experienced the same adverse reactions because ranitidine was not considered the culprit drug. Although ranitidine is known as a safe drug, it can also cause diverse adverse reactions, including anaphylaxis. This study demonstrates the need to pay attention to adverse reactions to ranitidine and consider ranitidine as a cause of anaphylaxis. © 2016 John Wiley & Sons Ltd.

Diagnostic accuracy of physical examination tests of the ankle/foot complex: a systematic review.

PubMed

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

2013-08-01

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. The purpose of this systematic review was to investigate the diagnostic accuracy of ankle/lower leg special tests. 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. 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. 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. 3a.

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

From High-Throughput Microarray-Based Screening to Clinical Application: The Development of a Second Generation Multigene Test for Breast Cancer Prognosis

PubMed Central

Brase, Jan C.; Kronenwett, Ralf; Petry, Christoph; Denkert, Carsten; Schmidt, Marcus

2013-01-01

Several multigene tests have been developed for breast cancer patients to predict the individual risk of recurrence. Most of the first generation tests rely on proliferation-associated genes and are commonly carried out in central reference laboratories. Here, we describe the development of a second generation multigene assay, the EndoPredict test, a prognostic multigene expression test for estrogen receptor (ER) positive, human epidermal growth factor receptor (HER2) negative (ER+/HER2−) breast cancer patients. The EndoPredict gene signature was initially established in a large high-throughput microarray-based screening study. The key steps for biomarker identification are discussed in detail, in comparison to the establishment of other multigene signatures. After biomarker selection, genes and algorithms were transferred to a diagnostic platform (reverse transcription quantitative PCR (RT-qPCR)) to allow for assaying formalin-fixed, paraffin-embedded (FFPE) samples. A comprehensive analytical validation was performed and a prospective proficiency testing study with seven pathological laboratories finally proved that EndoPredict can be reliably used in the decentralized setting. Three independent large clinical validation studies (n = 2,257) demonstrated that EndoPredict offers independent prognostic information beyond current clinicopathological parameters and clinical guidelines. The review article summarizes several important steps that should be considered for the development process of a second generation multigene test and offers a means for transferring a microarray signature from the research laboratory to clinical practice. PMID:27605191

Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research.

PubMed

Phillips, Kathryn A; Deverka, Patricia A; Sox, Harold C; Khoury, Muin J; Sandy, Lewis G; Ginsburg, Geoffrey S; Tunis, Sean R; Orlando, Lori A; Douglas, Michael P

2017-10-01

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address.Genet Med advance online publication 13 April 2017.

Effectiveness-implementation Hybrid Designs

PubMed Central

Curran, Geoffrey M.; Bauer, Mark; Mittman, Brian; Pyne, Jeffrey M.; Stetler, Cheryl

2013-01-01

Objectives This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a “hybrid effectiveness-implementation” typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. Results An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention’s impact on relevant outcomes. Conclusions The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice. PMID:22310560

Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research

PubMed Central

Phillips, Kathryn A.; Deverka, Patricia A.; Sox, Harold C.; Khoury, Muin J.; Sandy, Lewis G.; Ginsburg, Geoffrey S.; Tunis, Sean R.; Orlando, Lori A.; Douglas, Michael P.

2017-01-01

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address. Genet Med advance online publication 13 April 2017 PMID:28406488

International consensus on the most useful physical examination tests used by physiotherapists for patients with headache: A Delphi study.

PubMed

Luedtke, K; Boissonnault, W; Caspersen, N; Castien, R; Chaibi, A; Falla, D; Fernández-de-Las-Peñas, C; Hall, T; Hirsvang, J R; Horre, T; Hurley, D; Jull, G; Krøll, L S; Madsen, B K; Mallwitz, J; Miller, C; Schäfer, B; Schöttker-Königer, T; Starke, W; von Piekartz, H; Watson, D; Westerhuis, P; May, A

2016-06-01

A wide range of physical tests have been published for use in the assessment of musculoskeletal dysfunction in patients with headache. Which tests are used depends on a physiotherapist's clinical and scientific background as there is little guidance on the most clinically useful tests. To identify which physical examination tests international experts in physiotherapy consider the most clinically useful for the assessment of patients with headache. Delphi survey with pre-specified procedures based on a systematic search of the literature for physical examination tests proposed for the assessment of musculoskeletal dysfunction in patients with headache. Seventeen experts completed all three rounds of the survey. Fifteen tests were included in round one with eleven additional tests suggested by the experts. Finally eleven physical examination tests were considered clinically useful: manual joint palpation, the cranio-cervical flexion test, the cervical flexion-rotation test, active range of cervical movement, head forward position, trigger point palpation, muscle tests of the shoulder girdle, passive physiological intervertebral movements, reproduction and resolution of headache symptoms, screening of the thoracic spine, and combined movement tests. Eleven tests are suggested as a minimum standard for the physical examination of musculoskeletal dysfunctions in patients with headache. Copyright © 2016 Elsevier Ltd. All rights reserved.

OFFICE RADIOBIOLOGY AND THE TEST OF DIVIDED-DOSE IRRADIATION

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

Scanlon, P.W.

1963-08-01

A simple and quantitatively accurate radiobiologic test system for office use by the clinical radiotherapist is described. Radiation inhibition of Lemna minor, or duckweed grown in an aquarium, forms the basis of the test system. Results are reported from radiation-inhibition studies using this system with time-dose variables appropriate to the radiation dose. The system proved adequate for testing the relative biologic effectiveness of the various quantities of radiation employed in clinical radiotherapy. (C.H.)

South Africa: Durban's ante-natal clinic environment and its impact on a woman's choice to test for HIV during pregnancy.

PubMed

Groves, Allison K; Eyakuze, Cynthia

2010-10-01

Informed consent, counselling and confidentiality are key tenets of a human rights approach to HIV testing. In this article, based on an oral poster presentation at AIDS 2010, Allison K. Groves and Cynthia Eyakuze discuss the results of a study on HIV testing of women in ante-natal clinics in Durban, South Africa and how communication about testing may undermine the practice of obtaining informed consent.

Assessing clinical reasoning in optometry using the script concordance test.

PubMed

Faucher, Caroline; Dufour-Guindon, Marie-Pier; Lapointe, Gabrielle; Gagnon, Robert; Charlin, Bernard

2016-05-01

Clinical reasoning is central to any health profession but its development among learners is difficult to assess. Over the last few decades, the script concordance test (SCT) has been developed to solve this dilemma and has been used in many health professions; however, no study has been published on the use of the script concordance test in optometry. The purpose of this study was to develop and validate a script concordance test for the field of optometry. A 101-question script concordance test (27 short clinical scenarios) was developed and administered online to a convenience sample of 23 second-year and 19 fourth-year students of optometry. It was also administered to a reference panel of 12 experienced optometrists to develop the scoring key. An item-total correlation was calculated for each question. Cronbach's alpha coefficient was used to evaluate the script concordance test reliability and a t-test compared the two groups. A final 77-question script concordance test was created by eliminating questions with low item-total correlation. Cronbach's alpha for this optimised 77-question script concordance test was 0.80. A group comparison revealed that the second-year students' scores (n = 23; mean score = 66.4 ± 7.87 per cent) were statistically lower (t = -4.141; p < 0.001) than those of the fourth-year students (n = 19; mean score = 75.5 ± 5.97 per cent). The online script concordance test developed for this study was found to be both reliable and capable of discriminating between second- and fourth-year optometric students. These results demonstrate that the script concordance test may be considered as a new tool in the optometric educators' assessment arsenal. Further studies will be needed to cover additional levels of professional development. © 2016 The Authors. Clinical and Experimental Optometry © 2016 Optometry Australia.

Video head impulse test: a review of the literature.

PubMed

Alhabib, Salman F; Saliba, Issam

2017-03-01

Video head impulse test (vHIT) is a new testing which able to identify the overt and covert saccades and study the gain of vestibulo-ocular reflex (VOR) of each semicircular canal. The aim of this study is to review the clinical use of vHIT in patients with vestibular disorders in different diseases. PubMed and Cochrane databases were searched for all articles that defined vHIT, compared vHIT with another clinical test, and studied the efficacy of vHIT as diagnostic tools with vestibular disease. 37 articles about vHIT were reviewed. All articles studied the vHIT in English and French languages up to May 2015 were included in the review. Editorial articles or short comments, conference abstracts, animal studies, and language restriction were excluded from the review. Four systems were used in the literature to do the vHIT. vHIT is physiological quick test, which studied the VOR at high frequency of each semicircular canal by calculating the duration ratio between the head impulse and gaze deviation. vHIT is more sensitive than clinical head impulse test (cHIT), especially in patient with isolated covert saccades. vHIT test is diagnostic of vestibular weakness by gain reduction and the appearance of overt and covert saccades. If the vHIT is normal, then caloric test is mandatory to rule out a peripheral origin of vertigo. It is recommended to test each semicircular canal, as isolated vertical canal weakness was identified in the literature. More investigation would be required to determine the evolution of the VOR gain with the progression of the vestibular disease.

The Diagnosis of Urinary Tract Infection in Young Children (DUTY) Study Clinical Rule: Economic Evaluation.

PubMed

Hollingworth, William; Busby, John; Butler, Christopher C; O'Brien, Kathryn; Sterne, Jonathan A C; Hood, Kerenza; Little, Paul; Lawton, Michael; Birnie, Kate; Thomas-Jones, Emma; Harman, Kim; Hay, Alastair D

2017-04-01

To estimate the cost-effectiveness of a two-step clinical rule using symptoms, signs and dipstick testing to guide the diagnosis and antibiotic treatment of urinary tract infection (UTI) in acutely unwell young children presenting to primary care. Decision analytic model synthesising data from a multicentre, prospective cohort study (DUTY) and the wider literature to estimate the short-term and lifetime costs and healthcare outcomes (symptomatic days, recurrent UTI, quality adjusted life years) of eight diagnostic strategies. We compared GP clinical judgement with three strategies based on a 'coefficient score' combining seven symptoms and signs independently associated with UTI and four strategies based on weighted scores according to the presence/absence of five symptoms and signs. We compared dipstick testing versus laboratory culture in children at intermediate risk of UTI. Sampling, culture and antibiotic costs were lowest in high-specificity DUTY strategies (£1.22 and £1.08) compared to clinical judgement (£1.99). These strategies also approximately halved urine sampling (4.8% versus 9.1% in clinical judgement) without reducing sensitivity (58.2% versus 56.4%). Outcomes were very similar across all diagnostic strategies. High-specificity DUTY strategies were more cost-effective than clinical judgement in the short- (iNMB = £0.78 and £0.84) and long-term (iNMB =£2.31 and £2.50). Dipstick tests had poorer cost-effectiveness than laboratory culture in children at intermediate risk of UTI (iNMB = £-1.41). Compared to GPs' clinical judgement, high specificity clinical rules from the DUTY study could substantially reduce urine sampling, achieving lower costs and equivalent patient outcomes. Dipstick testing children for UTI is not cost-effective. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

EXAMINING EVIDENCE IN U.S. PAYER COVERAGE POLICIES FOR MULTI-GENE PANELS AND SEQUENCING TESTS

PubMed Central

Chambers, James D.; Saret, Cayla J.; Anderson, Jordan E.; Deverka, Patricia A.; Douglas, Michael P.; Phillips, Kathryn A.

2017-01-01

Objectives The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions. Methods We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study. Results Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73–100 percent), clinical studies in 69 percent (50–87 percent), technology assessments 47 percent (33–86 percent), systematic reviews or meta-analyses 31 percent (7–71 percent), and CEAs 5 percent (0–7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types. Conclusions Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions. PMID:29065945

EXAMINING EVIDENCE IN U.S. PAYER COVERAGE POLICIES FOR MULTI-GENE PANELS AND SEQUENCING TESTS.

PubMed

Chambers, James D; Saret, Cayla J; Anderson, Jordan E; Deverka, Patricia A; Douglas, Michael P; Phillips, Kathryn A

2017-01-01

The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions. We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study. Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73-100 percent), clinical studies in 69 percent (50-87 percent), technology assessments 47 percent (33-86 percent), systematic reviews or meta-analyses 31 percent (7-71 percent), and CEAs 5 percent (0-7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types. Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions.

Nursing Outcomes for Patients with Risk of Perioperative Positioning Injury.

PubMed

de Lima, Luciana Bjorklund; E Cardozo, Michelle Cardoso; Bernardes, Daniela de Souza; Rabelo-Silva, Eneida Rejane

2018-04-16

To select and refine the outcomes and indicators of Nursing Outcomes Classification for the diagnosis of risk for perioperative positioning injury. Validation study on expert consensus and refinement through pilot study. Eight outcomes and 35 indicators were selected in consensus. After clinical testing was performed, in which 10 patients were assessed at five different times. Eight outcomes and 33 indicators remained in the protocol. This study made it possible to select the most relevant outcomes and indicators to be measured for this diagnosis in clinical practice. Validation studies by consensus and clinical testing are important to promote the accuracy, creating opportunities to legitimize, and improve the concepts of taxonomies. © 2018 NANDA International, Inc.

[Clinical Tests Testing New Therapies for Stargardt Disease].

PubMed

Kousal, B; Ďuďáková, Ľ; Hlavatá, L; Lišková, P

2016-02-01

To provide information on currently ongoing clinical trials for Stargardt disease. We have searched the clinical trial register (www.clinicaltrials.gov) for the keyword "Stargardt" and list active ongoing studies. There are currently eight registered clinical trials enrolling patients with Stargardt disease; all in phase I or II aiming at four mechanisms of action: inhibition of the production of vitamin A toxic dimers, gene therapy restoring wild type transcription of the ABCA4 gene, neuroprotection preventing retinal cells from oxidative damage, and replacement of the damaged retinal pigment epithelium using stem cell therapy. The basic prerequisite for enrolment in the vast majority of clinical trials is confirmation of the clinical diagnosis by mutational analysis. The wide variety of therapies that are registered as clinical trials for Stargardt disease significantly raises the possibility that effective treatments will be available in the near future for this currently incurable condition and that molecular genetic testing should be increasingly considered. Stargardt disease, clinical trial, ABCA4, mutation.

Serological and molecular tools to diagnose visceral leishmaniasis: 2-years’ experience of a single center in Northern Italy

PubMed Central

Ortalli, Margherita; Attard, Luciano; Vanino, Elisa; Gaibani, Paolo; Vocale, Caterina; Rossini, Giada; Cagarelli, Roberto; Pierro, Anna; Billi, Patrizia; Mastroianni, Antonio; Di Cesare, Simona; Codeluppi, Mauro; Franceschini, Erica; Melchionda, Fraia; Gramiccia, Marina; Scalone, Aldo; Gentilomi, Giovanna A.; Landini, Maria P.

2017-01-01

The diagnosis of visceral leishmaniasis (VL) remains challenging, due to the limited sensitivity of microscopy, the poor performance of serological methods in immunocompromised patients and the lack of standardization of molecular tests. The aim of this study was to implement a combined diagnostic workflow by integrating serological and molecular tests with standardized clinical criteria. Between July 2013 and June 2015, the proposed workflow was applied to specimens obtained from 94 in-patients with clinical suspicion of VL in the Emilia-Romagna region, Northern Italy. Serological tests and molecular techniques were employed. Twenty-one adult patients (22%) had a confirmed diagnosis of VL by clinical criteria, serology and/or real-time polymerase chain reaction; 4 of these patients were HIV-positive. Molecular tests exhibited higher sensitivity than serological tests for the diagnosis of VL. In our experience, the rK39 immunochromatographic test was insufficiently sensitive for use as a screening test for the diagnosis of VL caused by L. infantum in Italy. However, as molecular tests are yet not standardized, further studies are required to identify an optimal screening test for Mediterranean VL. PMID:28832646

Validity and reliability of the NAB Naming Test.

PubMed

Sachs, Bonnie C; Rush, Beth K; Pedraza, Otto

2016-05-01

Confrontation naming is commonly assessed in neuropsychological practice, but few standardized measures of naming exist and those that do are susceptible to the effects of education and culture. The Neuropsychological Assessment Battery (NAB) Naming Test is a 31-item measure used to assess confrontation naming. Despite adequate psychometric information provided by the test publisher, there has been limited independent validation of the test. In this study, we investigated the convergent and discriminant validity, internal consistency, and alternate forms reliability of the NAB Naming Test in a sample of adults (Form 1: n = 247, Form 2: n = 151) clinically referred for neuropsychological evaluation. Results indicate adequate-to-good internal consistency and alternate forms reliability. We also found strong convergent validity as demonstrated by relationships with other neurocognitive measures. We found preliminary evidence that the NAB Naming Test demonstrates a more pronounced ceiling effect than other commonly used measures of naming. To our knowledge, this represents the largest published independent validation study of the NAB Naming Test in a clinical sample. Our findings suggest that the NAB Naming Test demonstrates adequate validity and reliability and merits consideration in the test arsenal of clinical neuropsychologists.

Recognizing and Reducing Analytical Errors and Sources of Variation in Clinical Pathology Data in Safety Assessment Studies.

PubMed

Schultze, A E; Irizarry, A R

2017-02-01

Veterinary clinical pathologists are well positioned via education and training to assist in investigations of unexpected results or increased variation in clinical pathology data. Errors in testing and unexpected variability in clinical pathology data are sometimes referred to as "laboratory errors." These alterations may occur in the preanalytical, analytical, or postanalytical phases of studies. Most of the errors or variability in clinical pathology data occur in the preanalytical or postanalytical phases. True analytical errors occur within the laboratory and are usually the result of operator or instrument error. Analytical errors are often ≤10% of all errors in diagnostic testing, and the frequency of these types of errors has decreased in the last decade. Analytical errors and increased data variability may result from instrument malfunctions, inability to follow proper procedures, undetected failures in quality control, sample misidentification, and/or test interference. This article (1) illustrates several different types of analytical errors and situations within laboratories that may result in increased variability in data, (2) provides recommendations regarding prevention of testing errors and techniques to control variation, and (3) provides a list of references that describe and advise how to deal with increased data variability.

Risks of Prostate Cancer Screening

MedlinePlus

... decrease the risk of dying from cancer. Scientists study screening tests to find those with the fewest risks and ... or routine screening test for prostate cancer. Screening tests for prostate cancer are under study, and there are screening clinical trials taking place ...

Comparison of clients of a mobile health van and a traditional STD clinic.

PubMed

Ellen, Jonathan M; Bonu, Sekhar; Arruda, Jaime S; Ward, Michael A; Vogel, Ruth

2003-04-01

The objective of this study was to determine if there were any demographic, behavioral, and clinical differences between clients seen aboard a mobile sexually transmitted disease (STD)/HIV clinic compared with those seen in a traditional municipal STD/HIV health clinic for receipt of STD/HIV services. Clients seen in the two different settings were interviewed about demographic characteristics, reasons for their visit, STD history, their HIV/STD risk factors, and the risk factors of their sex partners. Clients in both settings were also offered testing for syphilis, gonorrhea, chlamydia, and HIV. Results suggested that clients seen at the mobile clinic were older, more likely to be injecting drug users themselves and/or to have sex partners who were, or had engaged in prostitution for money or drugs. Over half (54.4%) of the mobile clinic clients sought testing for HIV, and they were far less likely to be seeking care for symptoms of an STD. In contrast, only 7.1% of municipal clinic clients indicated HIV testing as the reason for their visit, whereas nearly two thirds (64.5%) reported symptoms of disease. Two percent of municipal clinic clients and 5.4% of mobile clinic clients had a positive HIV test ( p<.001), and 17.8% of STD clinic clients and 5.6% of mobile van clients had a positive gonorrhea and/or test ( p<.001). These data suggest that a mobile STD/HIV clinic may be an effective strategy to reach individuals at high risk for HIV who are not being served by traditional municipal STD/HIV health clinics.

AMO Teledioptric System for age-related macular degeneration

NASA Astrophysics Data System (ADS)

Chou, Jim-Son; Ting, Albert C.

1994-05-01

A 2.5 X magnification system consisting of a two-zone intraocular implant and a spectacle was developed, tested, and clinically tried by fifty patients with cataract ad age-related macular degeneration. Optical bench testing results and clinical data confirmed that the field of view of the system was 2.6 times wider than an equivalent external telescope. The study also demonstrated that the implant itself was clinically equivalent to a standard monofocal intraocular lens for cataract. The clinical study indicated that higher magnification without compromising the compactness and optical quality was needed as the disease progressed. Also, a sound vision rehabilitation process is important to provide patients the full benefits of the system.

Correlation between lumbo-ventricular perfusion and MRI-CSF flow studies in idiopathic normal pressure hydrocephalus.

PubMed

Hakim, R; Black, P M

1998-01-01

After the initial description of normal pressure hydrocephalus (NPH) and its clinical triad, there has been a continuous interest from clinicians and researchers to set different diagnostic criteria that would make the selection of candidates for shunt surgery easier and more precise. A preliminary group of 12 patients was given a diagnosis of idiopathic normal pressure hydrocephalus by clinical and radiologic criteria. Each patient underwent two different tests: a magnetic resonance imaging-cerebrospinal fluid (MRI-CSF) flow study and a lumbo-ventricular perfusion test. The purpose was to compare the correlation of the results obtained with these tests and the clinical results obtained after CSF diversion. Eleven patients were given shunts and one was managed with lumbar punctures. One year after treatment, 10 of the 12 patients had improved with good results. The MRI-CSF flow studies were reliable in six patients; there were five false negatives and one false positive. The lumbo-ventricular perfusion test showed reliability in nine patients; there were two false negatives and one false positive. In only three patients were the results of both of these tests in accordance with the outcome. Even though there are few patients in this study so far, the data suggests that at the present time the most predictive guides for the diagnosis of NPH and its outcome after shunting are the clinical criteria and the radiological findings in computed tomography (CT) and/or MRI rather than lumbo-ventricular perfusion and CSF flow studies.

Presymptomatic electrophysiological tests predict clinical onset and survival in SOD1(G93A) ALS mice.

PubMed

Mancuso, Renzo; Osta, Rosario; Navarro, Xavier

2014-12-01

We assessed the predictive value of electrophysiological tests as a marker of clinical disease onset and survival in superoxide-dismutase 1 (SOD1)(G93A) mice. We evaluated the accuracy of electrophysiological tests in differentiating transgenic versus wild-type mice. We made a correlation analysis of electrophysiological parameters and the onset of symptoms, survival, and number of spinal motoneurons. Presymptomatic electrophysiological tests show great accuracy in differentiating transgenic versus wild-type mice, with the most sensitive parameter being the tibialis anterior compound muscle action potential (CMAP) amplitude. The CMAP amplitude at age 10 weeks correlated significantly with clinical disease onset and survival. Electrophysiological tests increased their survival prediction accuracy when evaluated at later stages of the disease and also predicted the amount of lumbar spinal motoneuron preservation. Electrophysiological tests predict clinical disease onset, survival, and spinal motoneuron preservation in SOD1(G93A) mice. This is a methodological improvement for preclinical studies. © 2014 Wiley Periodicals, Inc.

Eliciting preferences for priority setting in genetic testing: a pilot study comparing best-worst scaling and discrete-choice experiments.

PubMed

Severin, Franziska; Schmidtke, Jörg; Mühlbacher, Axel; Rogowski, Wolf H

2013-11-01

Given the increasing number of genetic tests available, decisions have to be made on how to allocate limited health-care resources to them. Different criteria have been proposed to guide priority setting. However, their relative importance is unclear. Discrete-choice experiments (DCEs) and best-worst scaling experiments (BWSs) are methods used to identify and weight various criteria that influence orders of priority. This study tests whether these preference eliciting techniques can be used for prioritising genetic tests and compares the empirical findings resulting from these two approaches. Pilot DCE and BWS questionnaires were developed for the same criteria: prevalence, severity, clinical utility, alternatives to genetic testing available, infrastructure for testing and care established, and urgency of care. Interview-style experiments were carried out among different genetics professionals (mainly clinical geneticists, researchers and biologists). A total of 31 respondents completed the DCE and 26 completed the BWS experiment. Weights for the levels of the six attributes were estimated by conditional logit models. Although the results derived from the DCE and BWS experiments differed in detail, we found similar valuation patterns in the DCE and BWS experiments. The respondents attached greatest value to tests with high clinical utility (defined by the availability of treatments that reduce mortality and morbidity) and to testing for highly prevalent conditions. The findings from this study exemplify how decision makers can use quantitative preference eliciting methods to measure aggregated preferences in order to prioritise alternative clinical interventions. Further research is necessary to confirm the survey results.

Durability of bonds and clinical success of adhesive restorations

PubMed Central

Carvalho, Ricardo M.; Manso, Adriana P.; Geraldeli, Saulo; Tay, Franklin R.; Pashley, David H.

2013-01-01

Resin-dentin bond strength durability testing has been extensively used to evaluate the effectiveness of adhesive systems and the applicability of new strategies to improve that property. Clinical effectiveness is determined by the survival rates of restorations placed in non-carious cervical lesions (NCCL). While there is evidence that the bond strength data generated in laboratory studies somehow correlates with the clinical outcome of NCCL restorations, it is questionable whether the knowledge of bonding mechanisms obtained from laboratory testing can be used to justify clinical performance of resin-dentin bonds. There are significant morphological and structural differences between the bonding substrate used in in vitro testing versus the substrate encountered in NCCL. These differences qualify NCCL as a hostile substrate for bonding, yielding bond strengths that are usually lower than those obtained in normal dentin. However, clinical survival time of NCCL restorations often surpass the durability of normal dentin tested in the laboratory. Likewise, clinical reports on the long-term survival rates of posterior composite restorations defy the relatively rapid rate of degradation of adhesive interfaces reported in laboratory studies. This article critically analyzes how the effectiveness of adhesive systems is currently measured, to identify gaps in knowledge where new research could be encouraged. The morphological and chemical analysis of bonded interfaces of resin composite restorations in teeth that had been in clinical service for many years, but were extracted for periodontal reasons, could be a useful tool to observe the ultrastructural characteristics of restorations that are regarded as clinically acceptable. This could help determine how much degradation is acceptable for clinical success. PMID:22192252

Combining skin prick, immediate skin application and specific-IgE testing in the diagnosis of peanut allergy in children.

PubMed

Wainstein, Brynn Kevin; Yee, Anthony; Jelley, Donna; Ziegler, Mary; Ziegler, John B

2007-05-01

Previous studies have suggested various diagnostic cut-offs of allergy tests for the diagnosis of clinical peanut allergy in children. There are few data relating to the use of combinations of these tests in children. We aimed to determine the validity of previously reported diagnostic cut-off levels of peanut allergen skin tests and peanut specific-immunoglobulin (Ig) E, as well as the usefulness of combinations of these, for predicting clinical peanut allergy in our Allergy Clinic. Children attending the Allergy Clinic with a positive peanut skin prick test (SPT; n = 84) were included in the study. Immediate skin application food tests (I-SAFT) using 1 g of peanut butter (positive if any wheals were detected at 15 min), peanut specific-IgE levels and open-label peanut food challenges were performed. Fifty-two of 85 peanut challenges were positive. Skin prick test specificity was 67% at >or=8 mm and 100% at >or=15 mm. The I-SAFT was 82% specific. A peanut specific-IgE level of 0.37 kU/l was 98% sensitive but 33% specific. A level of 10 kU/l was 100% specific. Combinations of a SPT of >or=8 mm with a positive I-SAFT and a peanut specific-IgE >or=0.37 kU/l were 88% specific with a sensitivity of 38%. Using challenge outcomes as the standard, available in vitro and in vivo diagnostic tests for peanut allergy have poor sensitivity and specificity and combining them does not significantly improve their clinical usefulness. Previously described diagnostic cut-off levels do not have general applicability. Allergy practitioners may need to interpret results of allergy tests in the context of their own practices.

Design of a Tablet Computer App for Facilitation of a Molecular Blood Culture Test in Clinical Microbiology and Preliminary Usability Evaluation

PubMed Central

Pape-Haugaard, Louise; Meltzer, Michelle C; Fuchs, Martin; Schønheyder, Henrik C; Hejlesen, Ole

2016-01-01

Background User mobility is an important aspect of the development of clinical information systems for health care professionals. Mobile phones and tablet computers have obtained widespread use by health care professionals, offering an opportunity for supporting the access to patient information through specialized applications (apps) while supporting the mobility of the users. The use of apps for mobile phones and tablet computers may support workflow of complex tasks, for example, molecular-based diagnostic tests in clinical microbiology. Multiplex Blood Culture Test (MuxBCT) is a molecular-based diagnostic test used for rapid identification of pathogens in positive blood cultures. To facilitate the workflow of the MuxBCT, a specialized tablet computer app was developed as an accessory to the diagnostic test. The app aims to reduce the complexity of the test by step-by-step guidance of microscopy and to assist users in reaching an exact bacterial or fungal diagnosis based on blood specimen observations and controls. Additionally, the app allows for entry of test results, and communication thereof to the laboratory information system (LIS). Objective The objective of the study was to describe the design considerations of the MuxBCT app and the results of a preliminary usability evaluation. Methods The MuxBCT tablet app was developed and set up for use in a clinical microbiology laboratory. A near-live simulation study was conducted in the clinical microbiology laboratory to evaluate the usability of the MuxBCT app. The study was designed to achieve a high degree of realism as participants carried out a scenario representing the context of use for the MuxBCT app. As the MuxBCT was under development, the scenario involved the use of molecular blood culture tests similar to the MuxBCT for identification of microorganisms from positive blood culture samples. The study participants were observed, and their interactions with the app were recorded. After the study, the participants were debriefed to clarify observations. Results Four medical laboratory technicians, for example, representative of end users of the app, participated in the clinical simulation study. Using the MuxBCT app, the study participants successfully identified and reported all microorganisms from the positive blood cultures examined. Three of the four participants reported that they found the app useful, while one study participant reported that she would prefer to make notes on paper and later enter them into the LIS. Conclusions The preliminary usability evaluation results indicate that use of the MuxBCT tablet app can facilitate the workflow of the MuxBCT diagnostic test. PMID:26993432

Clinical measures of balance in people with type two diabetes: A systematic literature review.

PubMed

Dixon, C J; Knight, T; Binns, E; Ihaka, B; O'Brien, D

2017-10-01

Approximately 422 million people have diabetes mellitus worldwide, with the majority diagnosed with type 2 diabetes mellitus (T2DM). The complications of diabetes mellitus include diabetic peripheral neuropathy (DPN) and retinopathy, both of which can lead to balance impairments. Balance assessment is therefore an integral component of the clinical assessment of a person with T2DM. Although there are a variety of balance measures available, it is uncertain which measures are the most appropriate for this population. Therefore, the aim of this study was to conduct a systematic review on clinical balance measures used with people with T2DM and DPN. Databases searched included: CINAHL plus, MEDLINE, SPORTDiscus, Dentistry and Oral Sciences source, and SCOPUS. Key terms, inclusion and exclusion criteria were used to identify appropriate studies. Identified studies were critiqued using the Downs and Black appraisal tool. Eight studies were included, these studies incorporated a total of ten different clinical balance measures. The balance measures identified included the Dynamic Balance Test, balance walk, tandem and unipedal stance, Functional Reach Test, Clinical Test of Sensory Interaction and Balance, Berg Balance Scale, Tinetti Performance-Oriented Mobility Assessment, Activity-Specific Balance Confidence Scale, Timed Up and Go test, and the Dynamic Gait Index. Numerous clinical balance measures were used for people with T2DM. However, the identified balance measures did not assess all of the systems of balance, and most had not been validated in a T2DM population. Therefore, future research is needed to identify the validity of a balance measure that assesses these systems in people with T2DM. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Clinical pharmacogenomics: patient perspectives of pharmacogenomic testing and the incidence of actionable test results in a chronic disease cohort.

PubMed

Mukherjee, Chandrama; Sweet, Kevin M; Luzum, Jasmine A; Abdel-Rasoul, Mahmoud; Christman, Michael F; Kitzmiller, Joseph P

2017-09-01

This study aimed to examine pharmacogenomic test results and patient perspectives at an academic cardiovascular medicine clinic. Test results for three common cardiovascular drug-gene tests (warfarin- CYP2C9-VKORC1 , clopidogrel- CYP2C19 and simvastatin- SLCO1B1 ) of 208 patients in the Ohio State University-Coriell Personalized Medicine Collaborative were examined to determine the incidence of potentially actionable test results. A post-hoc, anonymous, patient survey was also conducted. Potentially actionable test results for at least one of the three drug-gene tests were determined in 170 (82%) patients. Survey responses (n = 134) suggested that patients generally considered their test results to be important (median of 7.5 on a 10-point scale of importance) and were interested (median of 7.3 on a 10-point scale of interest) in a Clinical Pharmacogenomic Service. Attitudes toward pharmacogenomic testing were generally favorable, and potentially actionable test results were not uncommon in this cardiovascular medicine cohort.

Quantification of human motion: gait analysis-benefits and limitations to its application to clinical problems.

PubMed

Simon, Sheldon R

2004-12-01

The technology supporting the analysis of human motion has advanced dramatically. Past decades of locomotion research have provided us with significant knowledge about the accuracy of tests performed, the understanding of the process of human locomotion, and how clinical testing can be used to evaluate medical disorders and affect their treatment. Gait analysis is now recognized as clinically useful and financially reimbursable for some medical conditions. Yet, the routine clinical use of gait analysis has seen very limited growth. The issue of its clinical value is related to many factors, including the applicability of existing technology to addressing clinical problems; the limited use of such tests to address a wide variety of medical disorders; the manner in which gait laboratories are organized, tests are performed, and reports generated; and the clinical understanding and expectations of laboratory results. Clinical use is most hampered by the length of time and costs required for performing a study and interpreting it. A "gait" report is lengthy, its data are not well understood, and it includes a clinical interpretation, all of which do not occur with other clinical tests. Current biotechnology research is seeking to address these problems by creating techniques to capture data rapidly, accurately, and efficiently, and to interpret such data by an assortment of modeling, statistical, wave interpretation, and artificial intelligence methodologies. The success of such efforts rests on both our technical abilities and communication between engineers and clinicians.

An inexpensive modification of the laboratory computer display changes emergency physicians' work habits and perceptions.

PubMed

Marinakis, Harry A; Zwemer, Frank L

2003-02-01

Little is known about how the availability of laboratory data affects emergency physicians' practice habits and satisfaction. We modified our clinical information system to display laboratory test status with continuous updates, similar to an airport arrival display. The objective of this study was to determine whether the laboratory test status display altered emergency physicians' work habits and increased satisfaction compared with the time period before implementation of laboratory test status. A retrospective analysis was performed of emergency physicians' actual use of the clinical information system before and after implementation of the laboratory test status display. Emergency physicians were retrospectively surveyed regarding the effect of laboratory test status display on their practice habits and clinical information system use. Survey responses were matched with actual use of the clinical information system. Data were analyzed by using dependent t tests and Pearson correlation coefficients. The study was conducted at a university hospital. Clinical information system use by 46 emergency physicians was analyzed. Twenty-five surveys were returned (71.4% of available emergency physicians). All emergency physicians perceived fewer clinical information system log ons per day after laboratory test status display. The actual average decrease was 19%. Emergency physicians who reported the greatest decrease in log ons per day tended to have the greatest actual decrease (r =-0.36). There was no significant correlation between actual and perceived total time logged on (r =0.08). In regard to effect on emergency physicians' practice habits, 95% reported increased efficiency, 80% reported improved satisfaction with data access, and 65% reported improved communication with patients. An inexpensive computer modification, laboratory test status display, significantly increased subjective efficiency, changed work habits, and improved satisfaction regarding data access and patient communication among emergency physicians. Knowledge of the test queue changed emergency physician behavior and improved satisfaction.

Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact.

PubMed

Curran, Geoffrey M; Bauer, Mark; Mittman, Brian; Pyne, Jeffrey M; Stetler, Cheryl

2012-03-01

This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.

Evaluation of leishmanin skin test and its relationship with the clinical form and duration of cutaneous leishmaniasis.

PubMed

Sadeghian, Giti; Momeni, Ali; Siadat, Amir Hossein; Yousefi, Pedram

2006-12-10

Cellular immunity plays a major role in natural defense against cutaneous leishmaniasis. The leishmanin skin test (LST) is one method of evaluating the infected individual's immune response to leishmania. Our objective in this study was to evaluate the relationship between positivity of the LST with duration of disease, clinical form, number of lesions, and age and gender of the patient. This open study was performed on 198 patients who were affected by cutaneous leishmaniasis before any treatment was administered. Following confirmation of the diagnosis of cutaneous leishmaniasis, relevant data were recorded, including age, gender, occupation, address, duration of disease, clinical form, location of the lesions, and the number of the lesions. After performing the leishmanin skin test, patients were treated for leishmaniasis according to the type and severity of the disease. For patients whose LST was initially negative, the test was repeated every 15 days. If the LST was still negative after 4 months, the test was repeated every 3 months; if the LST remained negative 12 months after the first test, the result was considered negative. The collected data were statistically analyzed using the SPSS program. In 179 patients (90.4%) the test was positive at the time of the first test. In 7 patients (3.8%) it became positive during treatment, and in 12 patients (6 percent) the test remained negative until the end of study. There was no significant relationship between the skin lesion number and the positivity of the leishmanin skin test (p = 0.98). There was no significant relationship between age group and diameter of the induration. All of the patients who had negative leishmnanin test at the 12 months followup visit had one lesion only. This study showed that there is no relationship between age, gender, or duration of disease with positivity of the LST or degree of positivity, but there is a significant relationship with the clinical form of cutaneous leishmaniasis at the final test (12 patients). This study showed that there is no significant relationship between positivity of LST and the type of treatment.

Short-interval test-retest interrater reliability of the Structured Clinical Interview for DSM-III-R personality disorders (SCID-II) in outpatients.

PubMed

Dreessen, L; Arntz, A

1998-01-01

The short-interval test-retest interrater reliability of the Structured Clinical Interview for DSM-III-R personality disorders (SCID-II) was studied in a psychotherapy outpatient group whose main complaint was mostly an Axis I anxiety disorder. Using a test-retest approach to assess interrater reliability, three sources of variance were taken into account (rater variance in the elicitation and interpretation of information and patient variance across interviews). Base rate requirements were established before calculating reliability coefficients. On the whole, interrater agreement on the SCID-II was found to be satisfactory, except for the histrionic personality traits. This is the first study that has estimated short-interval test-retest interrater reliability of the SCID-II in outpatients, and also the first that has studied single SCID-II traits and dimensional diagnoses. The results found support the use of the SCID-II as a diagnostic instrument for clinical and research purposes.

Home-based versus clinic-based specimen collection in the management of Chlamydia trachomatis and Neisseria gonorrhoeae infections.

PubMed

Fajardo-Bernal, Luisa; Aponte-Gonzalez, Johanna; Vigil, Patrick; Angel-Müller, Edith; Rincon, Carlos; Gaitán, Hernando G; Low, Nicola

2015-09-29

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most frequent causes of bacterial sexually transmitted infections (STIs). Management strategies that reduce losses in the clinical pathway from infection to cure might improve STI control and reduce complications resulting from lack of, or inadequate, treatment. To assess the effectiveness and safety of home-based specimen collection as part of the management strategy for Chlamydia trachomatis and Neisseria gonorrhoeae infections compared with clinic-based specimen collection in sexually-active people. We searched the Cochrane Sexually Transmitted Infections Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS on 27 May 2015, together with the World Health Organization International Clinical Trials Registry (ICTRP) and ClinicalTrials.gov. We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies. Randomized controlled trials (RCTs) of home-based compared with clinic-based specimen collection in the management of C. trachomatis and N. gonorrhoeae infections. Three review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We contacted study authors for additional information. We resolved any disagreements through consensus. We used standard methodological procedures recommended by Cochrane. The primary outcome was index case management, defined as the number of participants tested, diagnosed and treated, if test positive. Ten trials involving 10,479 participants were included. There was inconclusive evidence of an effect on the proportion of participants with index case management (defined as individuals tested, diagnosed and treated for CT or NG, or both) in the group with home-based (45/778, 5.8%) compared with clinic-based (51/788, 6.5%) specimen collection (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.60 to 1.29; 3 trials, I² = 0%, 1566 participants, moderate quality). Harms of home-based specimen collection were not evaluated in any trial. All 10 trials compared the proportions of individuals tested. The results for the proportion of participants completing testing had high heterogeneity (I² = 100%) and were not pooled. We could not combine data from individual studies looking at the number of participants tested because the proportions varied widely across the studies, ranging from 30% to 96% in home group and 6% to 97% in clinic group (low-quality evidence). The number of participants with positive test was lower in the home-based specimen collection group (240/2074, 11.6%) compared with the clinic-based group (179/967, 18.5%) (RR 0.72, 95% CI 0.61 to 0.86; 9 trials, I² = 0%, 3041 participants, moderate quality). Home-based specimen collection could result in similar levels of index case management for CT or NG infection when compared with clinic-based specimen collection. Increases in the proportion of individuals tested as a result of home-based, compared with clinic-based, specimen collection are offset by a lower proportion of positive results. The harms of home-based specimen collection compared with clinic-based specimen collection have not been evaluated. Future RCTs to assess the effectiveness of home-based specimen collection should be designed to measure biological outcomes of STI case management, such as proportion of participants with negative tests for the relevant STI at follow-up.

Reliability, standard error, and minimum detectable change of clinical pressure pain threshold testing in people with and without acute neck pain.

PubMed

Walton, David M; Macdermid, Joy C; Nielson, Warren; Teasell, Robert W; Chiasson, Marco; Brown, Lauren

2011-09-01

Clinical measurement. To evaluate the intrarater, interrater, and test-retest reliability of an accessible digital algometer, and to determine the minimum detectable change in normal healthy individuals and a clinical population with neck pain. Pressure pain threshold testing may be a valuable assessment and prognostic indicator for people with neck pain. To date, most of this research has been completed using algometers that are too resource intensive for routine clinical use. Novice raters (physiotherapy students or clinical physiotherapists) were trained to perform algometry testing over 2 clinically relevant sites: the angle of the upper trapezius and the belly of the tibialis anterior. A convenience sample of normal healthy individuals and a clinical sample of people with neck pain were tested by 2 different raters (all participants) and on 2 different days (healthy participants only). Intraclass correlation coefficient (ICC), standard error of measurement, and minimum detectable change were calculated. A total of 60 healthy volunteers and 40 people with neck pain were recruited. Intrarater reliability was almost perfect (ICC = 0.94-0.97), interrater reliability was substantial to near perfect (ICC = 0.79-0.90), and test-retest reliability was substantial (ICC = 0.76-0.79). Smaller change was detectable in the trapezius compared to the tibialis anterior. This study provides evidence that novice raters can perform digital algometry with adequate reliability for research and clinical use in people with and without neck pain.

A critical analysis of test-retest reliability in instrument validation studies of cancer patients under palliative care: a systematic review

PubMed Central

2014-01-01

Background Patient-reported outcome validation needs to achieve validity and reliability standards. Among reliability analysis parameters, test-retest reliability is an important psychometric property. Retested patients must be in a clinically stable condition. This is particularly problematic in palliative care (PC) settings because advanced cancer patients are prone to a faster rate of clinical deterioration. The aim of this study was to evaluate the methods by which multi-symptom and health-related qualities of life (HRQoL) based on patient-reported outcomes (PROs) have been validated in oncological PC settings with regards to test-retest reliability. Methods A systematic search of PubMed (1966 to June 2013), EMBASE (1980 to June 2013), PsychInfo (1806 to June 2013), CINAHL (1980 to June 2013), and SCIELO (1998 to June 2013), and specific PRO databases was performed. Studies were included if they described a set of validation studies. Studies were included if they described a set of validation studies for an instrument developed to measure multi-symptom or multidimensional HRQoL in advanced cancer patients under PC. The COSMIN checklist was used to rate the methodological quality of the study designs. Results We identified 89 validation studies from 746 potentially relevant articles. From those 89 articles, 31 measured test-retest reliability and were included in this review. Upon critical analysis of the overall quality of the criteria used to determine the test-retest reliability, 6 (19.4%), 17 (54.8%), and 8 (25.8%) of these articles were rated as good, fair, or poor, respectively, and no article was classified as excellent. Multi-symptom instruments were retested over a shortened interval when compared to the HRQoL instruments (median values 24 hours and 168 hours, respectively; p = 0.001). Validation studies that included objective confirmation of clinical stability in their design yielded better results for the test-retest analysis with regard to both pain and global HRQoL scores (p < 0.05). The quality of the statistical analysis and its description were of great concern. Conclusion Test-retest reliability has been infrequently and poorly evaluated. The confirmation of clinical stability was an important factor in our analysis, and we suggest that special attention be focused on clinical stability when designing a PRO validation study that includes advanced cancer patients under PC. PMID:24447633

Clinical usefulness of the pendulum test using a NK table to measure the spasticity of patients with brain lesions.

PubMed

Kim, Yong-Wook

2013-10-01

. [Purpose] The purpose of the present study was to investigate the clinical usefulness (reliability and validity) of the pendulum test using a Noland-Kuckhoff (NK) table with an attached electrogoniometer to measure the spasticity of patients with brain lesions. [Subjects] The subjects were 31 patients with stroke or traumatic brain injury. [Methods] The intraclass correlation coefficient (ICC) was used to verify the test-retest reliability of spasticity measures obtained using the pendulum test. Pearson's product correlation coefficient was used to examine the validity of the pendulum test using the amplitude of the patellar tendon reflex (PTR) test, an objective and quantitative measure of spasticity. [Results] The test-retest reliability was high, reflecting a significant correlation between the test and the retest (ICCs = 0.95-0.97). A significant negative correlation was found between the amplitude of the PTR test and the four variables measured in the pendulum test (r = -0.77- -0.85). [Conclusion] The pendulum test using a NK table is an objective measure of spasticity and can be used in the clinical setting in place of more expensive and complicated equipment. Further studies are needed to investigate the therapeutic effect of this method on spasticity.

Reliability and validity of clinical tests to assess the anatomical integrity of the cervical spine in adults with neck pain and its associated disorders: Part 1-A systematic review from the Cervical Assessment and Diagnosis Research Evaluation (CADRE) Collaboration.

PubMed

Lemeunier, Nadège; da Silva-Oolup, S; Chow, N; Southerst, D; Carroll, L; Wong, J J; Shearer, H; Mastragostino, P; Cox, J; Côté, E; Murnaghan, K; Sutton, D; Côté, P

2017-09-01

To determine the reliability and validity of clinical tests to assess the anatomical integrity of the cervical spine in adults with neck pain and its associated disorders. We updated the systematic review of the 2000-2010 Bone and Joint Decade Task Force on Neck Pain and its Associated Disorders. We also searched the literature to identify studies on the reliability and validity of Doppler velocimetry for the evaluation of cervical arteries. Two independent reviewers screened and critically appraised studies. We conducted a best evidence synthesis of low risk of bias studies and ranked the phases of investigations using the classification proposed by Sackett and Haynes. We screened 9022 articles and critically appraised 8 studies; all 8 studies had low risk of bias (three reliability and five validity Phase II-III studies). Preliminary evidence suggests that the extension-rotation test may be reliable and has adequate validity to rule out pain arising from facet joints. The evidence suggests variable reliability and preliminary validity for the evaluation of cervical radiculopathy including neurological examination (manual motor testing, dermatomal sensory testing, deep tendon reflexes, and pathological reflex testing), Spurling's and the upper limb neurodynamic tests. No evidence was found for doppler velocimetry. Little evidence exists to support the use of clinical tests to evaluate the anatomical integrity of the cervical spine in adults with neck pain and its associated disorders. We found preliminary evidence to support the use of the extension-rotation test, neurological examination, Spurling's and the upper limb neurodynamic tests.

Clinical decision making in response to performance validity test failure in a psychiatric setting.

PubMed

Marcopulos, Bernice A; Caillouet, Beth A; Bailey, Christopher M; Tussey, Chriscelyn; Kent, Julie-Ann; Frederick, Richard

2014-01-01

This study examined the clinical utility of a performance validity test (PVT) for screening consecutive referrals (N = 436) to a neuropsychology service at a state psychiatric hospital treating both civilly committed and forensic patients. We created a contingency table with Test of Memory Malingering (TOMM) pass/fail (355/81) and secondary gain present/absent (181/255) to examine pass rates associated with patient demographic, clinical and forensic status characteristics. Of the 81 failed PVTs, 48 had secondary gain defined as active criminal legal charges; 33 failed PVTs with no secondary gain. These individuals tended to be older, female, Caucasian, and civilly committed compared with the group with secondary gain who failed. From estimations of TOMM False Positive Rate and True Positive Rate we estimated base rates of neurocognitive malingering for our clinical population using the Test Validation Summary (TVS; Frederick & Bowden, 2009 ). Although PVT failure is clearly more common in a group with secondary gain (31%), there were a number of false positives (11%). Clinical ratings of patients without gain who failed suggested cognitive deficits, behavioral issues, and inattention. Low scores on PVTs in the absence of secondary gain provide useful information on test engagement and can inform clinical decisions about testing.

A comprehensive overview of urogenital, anorectal and oropharyngeal Neisseria gonorrhoeae testing and diagnoses among different STI care providers: a cross-sectional study.

PubMed

den Heijer, Casper D J; Hoebe, Christian J P A; van Liere, Geneviève A F S; van Bergen, Jan E A M; Cals, Jochen W L; Stals, Frans S; Dukers-Muijrers, Nicole H T M

2017-04-20

Gonorrhoea, caused by Neisseria gonorrhoeae (NG), can cause reproductive morbidity, is increasingly becoming resistant to antibiotics and is frequently asymptomatic, which shows the essential role of NG test practice. In this study we wanted to compare NG diagnostic testing procedures between different STI care providers serving a defined geographic Dutch region (280,000 inhabitants). Data on laboratory testing and diagnosis of urogenital and extragenital (i.e. anorectal and oropharyngeal) NG were retrieved from general practitioners (GPs), an STI clinic, and gynaecologists (2006-2010). Per provider, we assessed their contribution regarding the total number of tests performed and type of populations tested, the proportion of NG positives re-tested (3-12 months after treatment) and test-of-cure (TOC, within 3 months post treatment). Overall, 17,702 NG tests (48.7% STI clinic, 38.2% GPs, 13.1% gynaecologists) were performed during 15,458 patient visits. From this total number of tests, 2257 (12.7%) were extragenital, of which 99.4% were performed by the STI clinic. Men were mostly tested at the STI clinic (71%) and women by their GP (43%). NG positivity per visit was 1.6%; GP 1.9% (n = 111), STI clinic 1.7% (n = 131) and gynaecology 0.2% (n = 5). NG positivity was associated with Chlamydia trachomatis positivity (OR: 2.06, 95% confidence interval: 1.46-2.92). Per anatomical location, the proportion of NG positives re-tested were: urogenital 20.3% (n = 36), anorectal 43.6% (n = 17) and oropharyngeal 57.1% (n = 20). NG positivity among re-tests was 16.9%. Proportions of NG positives with TOC by anatomical location were: urogenital 10.2% (n = 18), anorectal 17.9% (n = 7) and oropharyngeal 17.1% (n = 6). To achieve best practice in relation to NG testing, we recommend that: 1) GPs test at extragenital sites, especially men who have sex with men (MSM), 2) all care providers consider re-testing 3 to 12 months after NG diagnosis and 3) TOC is performed following oropharyngeal NG diagnosis in settings which provide services to higher-risk men and women (such as STI clinics).

Making it work: health care provider perspectives on strategies to increase colorectal cancer screening in federally qualified health centers.

PubMed

Gwede, Clement K; Davis, Stacy N; Quinn, Gwendolyn P; Koskan, Alexis M; Ealey, Jamila; Abdulla, Rania; Vadaparampil, Susan T; Elliott, Gloria; Lopez, Diana; Shibata, David; Roetzheim, Richard G; Meade, Cathy D

2013-12-01

Colorectal cancer screening (CRCS) rates are low among men and women who seek health care at federally qualified health centers (FQHCs). This study explores health care providers' perspectives about their patient's motivators and impediments to CRCS and receptivity to preparatory education. A mixed methods design consisting of in-depth interviews, focus groups, and a short survey is used in this study. The participants of this study are 17 health care providers practicing in FQHCs in the Tampa Bay area. Test-specific patient impediments and motivations were identified including fear of abnormal findings, importance of offering less invasive fecal occult blood tests, and need for patient-centered test-specific educational materials in clinics. Opportunities to improve provider practices were identified including providers' reliance on patients' report of symptoms as a cue to recommend CRCS and overemphasis of clinic-based guaiac stool tests. This study adds to the literature on CRCS test-specific motivators and impediments. Providers offered unique approaches for motivating patients to follow through with recommended CRCS and were receptive to in-clinic patient education. Findings readily inform the design of educational materials and interventions to increase CRCS in FQHCs.

Using Theater to Teach Clinical Empathy: A Pilot Study

PubMed Central

Leong, David; Anderson, Aaron; Wenzel, Richard P.

2007-01-01

Background Clinical empathy, a critical skill for the doctor–patient relationship, is infrequently taught in graduate medical education. No study has tested if clinical empathy can be taught effectively. Objective To assess whether medicine residents can learn clinical empathy techniques from theater professors. Design A controlled trial of a clinical empathy curriculum taught and assessed by 4 theater professors. Setting Virginia Commonwealth University, Richmond, Virginia, a large urban university and health system. Participants Twenty Internal Medicine residents: 14 in the intervention group, 6 in the control group. Intervention Six hours of classroom instruction and workshop time with professors of theater. Measurements Scores derived from an instrument with 6 subscores designed to measure empathy in real-time patient encounters. Baseline comparisons were made using two-sample T tests. A mixed-effects analysis of variance model was applied to test for significance between the control and intervention groups. Results The intervention group demonstrated significant improvement (p ≤ .011) across all 6 subscores between pre-intervention and post-intervention observations. Compared to the control group, the intervention group had better posttest scores in 5 of 6 subscores (p ≤ .01). Limitations The study was neither randomized nor blinded. Conclusions Collaborative efforts between the departments of theater and medicine are effective in teaching clinical empathy techniques. PMID:17486385

Multiplex tests to identify gastrointestinal bacteria, viruses and parasites in people with suspected infectious gastroenteritis: a systematic review and economic analysis.

PubMed

Freeman, Karoline; Mistry, Hema; Tsertsvadze, Alexander; Royle, Pam; McCarthy, Noel; Taylor-Phillips, Sian; Manuel, Rohini; Mason, James

2017-04-01

Gastroenteritis is a common, transient disorder usually caused by infection and characterised by the acute onset of diarrhoea. Multiplex gastrointestinal pathogen panel (GPP) tests simultaneously identify common bacterial, viral and parasitic pathogens using molecular testing. By providing test results more rapidly than conventional testing methods, GPP tests might positively influence the treatment and management of patients presenting in hospital or in the community. To systematically review the evidence for GPP tests [xTAG ® (Luminex, Toronto, ON, Canada), FilmArray (BioFire Diagnostics, Salt Lake City, UT, USA) and Faecal Pathogens B (AusDiagnostics, Beaconsfield, NSW, Australia)] and to develop a de novo economic model to compare the cost-effectiveness of GPP tests with conventional testing in England and Wales. Multiple electronic databases including MEDLINE, EMBASE, Web of Science and the Cochrane Database were searched from inception to January 2016 (with supplementary searches of other online resources). Eligible studies included patients with acute diarrhoea; comparing GPP tests with standard microbiology techniques; and patient, management, test accuracy or cost-effectiveness outcomes. Quality assessment of eligible studies used tailored Quality Assessment of Diagnostic Accuracy Studies-2, Consolidated Health Economic Evaluation Reporting Standards and Philips checklists. The meta-analysis included positive and negative agreement estimated for each pathogen. A de novo decision tree model compared patients managed with GPP testing or comparable coverage with patients managed using conventional tests, within the Public Health England pathway. Economic models included hospital and community management of patients with suspected gastroenteritis. The model estimated costs (in 2014/15 prices) and quality-adjusted life-year losses from a NHS and Personal Social Services perspective. Twenty-three studies informed the review of clinical evidence (17 xTAG, four FilmArray, two xTAG and FilmArray, 0 Faecal Pathogens B). No study provided an adequate reference standard with which to compare the test accuracy of GPP with conventional tests. A meta-analysis (of 10 studies) found considerable heterogeneity; however, GPP testing produces a greater number of pathogen-positive findings than conventional testing. It is unclear whether or not these additional 'positives' are clinically important. The review identified no robust evidence to inform consequent clinical management of patients. There is considerable uncertainty about the cost-effectiveness of GPP panels used to test for suspected infectious gastroenteritis in hospital and community settings. Uncertainties in the model include length of stay, assumptions about false-positive findings and the costs of tests. Although there is potential for cost-effectiveness in both settings, key modelling assumptions need to be verified and model findings remain tentative. No test-treat trials were retrieved. The economic model reflects one pattern of care, which will vary across the NHS. The systematic review and cost-effectiveness model identify uncertainties about the adoption of GPP tests within the NHS. GPP testing will generally correctly identify pathogens identified by conventional testing; however, these tests also generate considerable additional positive results of uncertain clinical importance. An independent reference standard may not exist to evaluate alternative approaches to testing. A test-treat trial might ascertain whether or not additional GPP 'positives' are clinically important or result in overdiagnoses, whether or not earlier diagnosis leads to earlier discharge in patients and what the health consequences of earlier intervention are. Future work might also consider the public health impact of different testing treatments, as test results form the basis for public health surveillance. This study is registered as PROSPERO CRD2016033320. The National Institute for Health Research Health Technology Assessment programme.

Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings:  A Health Program Evaluation Framework Case Study From East Africa.

PubMed

Zhang, Helen L; Omondi, Michael W; Musyoka, Augustine M; Afwamba, Isaac A; Swai, Remigi P; Karia, Francis P; Muiruri, Charles; Reddy, Elizabeth A; Crump, John A; Rubach, Matthew P

2016-08-01

Using a clinical research laboratory as a case study, we sought to characterize barriers to maintaining Good Clinical Laboratory Practice (GCLP) services in a developing world setting. Using a US Centers for Disease Control and Prevention framework for program evaluation in public health, we performed an evaluation of the Kilimanjaro Christian Medical Centre-Duke University Health Collaboration clinical research laboratory sections of the Kilimanjaro Clinical Research Institute in Moshi, Tanzania. Laboratory records from November 2012 through October 2014 were reviewed for this analysis. During the 2-year period of study, seven instrument malfunctions suspended testing required for open clinical trials. A median (range) of 9 (1-55) days elapsed between instrument malfunction and biomedical engineer service. Sixteen (76.1%) of 21 suppliers of reagents, controls, and consumables were based outside Tanzania. Test throughput among laboratory sections used a median (range) of 0.6% (0.2%-2.7%) of instrument capacity. Five (55.6%) of nine laboratory technologists left their posts over 2 years. These findings demonstrate that GCLP laboratory service provision in this setting is hampered by delays in biomedical engineer support, delays and extra costs in commodity procurement, low testing throughput, and high personnel turnover. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Atherosclerotic renal artery stenosis: epidemiology, cardiovascular outcomes, and clinical prediction rules.

PubMed

Zoccali, Carmine; Mallamaci, Francesca; Finocchiaro, Pietro

2002-11-01

Atherosclerotic renal artery stenosis is the most common primary disease of the renal arteries, and it is associated with two major clinical syndromes, ischemic renal disease and hypertension. The prevalence of this disease in the population is undefined because there is no simple and reliable test that can be applied on a large scale. Renal artery involvement in patients with coronary heart disease and/or heart failure is frequent, and it may influence cardiovascular outcomes and survival in these patients. Suspecting renal arterial stenosis in patients with recurrent episodes of pulmonary edema is justified by observations showing that about one third of elderly patients with heart failure display atherosclerotic renal disease. Whether interventions aimed at restoring arterial patency may reduce the high mortality in patients with heart failure is still unclear because, to date, no prospective study has been carried out in these patients. Increased awareness of the need for cost containment has renewed the interest in clinical cues for suspecting renovascular hypertension. In this regard, the DRASTIC study constitutes an important attempt at validating clinical prediction rules. In this study, a clinical rule was derived that predicted renal artery stenosis as efficiently as renal scintigraphy (sensitivity: clinical rule, 65% versus scintigraphy, 72%; specificity: 87% versus 92%). When tested in a systematic and quantitative manner, clinical findings can perform as accurately as more complex tests in the detection of renal artery stenosis.

[Skills lab training in veterinary medicine. Effective preparation for clinical work at the small animal clinic of the University for Veterinary Medicine Hannover, Foundation].

PubMed

Engelskirchen, Simon; Ehlers, Jan; Kirk, Ansgar T; Tipold, Andrea; Dilly, Marc

2017-09-20

During five and a half years of studying veterinary medicine, students should in addition to theoretical knowledge acquire sufficient practical skills. Considering animal welfare and ethical aspects, opportunities for hands-on learning on living animals are limited because of the high annual number of students. The first German veterinary clinical-skills lab, established in 2013 at the University for Veterinary Medicine Hannover, Foundation (TiHo), offers opportunities for all students to learn, train and repeat clinical skills on simulators and models as frequently as they would like, until they feel sufficiently confident to transfer these skills to living animals. This study describes the establishment of clinical-skills lab training within the students' practical education, using the example of the small-animal clinic of the TiHo. Two groups of students were compared: without skills lab training (control group K) and with skills lab training (intervention group I). At the end of both the training and a subsequent 10-week clinical rotation in different sections of the clinic, an objective structured clinical examination (OSCE) was performed, testing the students' practical skills at 15 stations. An additional multiple-choice test was performed before and after the clinical rotation to evaluate the increased theoretical knowledge. Students of group I achieved significantly (p ≤ 0.05) better results in eight of the 15 tested skills. The multiple-choice test revealed a significant (p ≤ 0.05) gain of theoretical knowledge in both groups without any differences between the groups. Students displayed a high degree of acceptance of the skills lab training. Using simulators and models in veterinary education is an efficient teaching concept, and should be used continually and integrated in the curriculum.

Predicting the clinical performance of dental students with a manual dexterity test

PubMed Central

Lugassy, Diva; Levanon, Yafi; Pilo, Raphael; Shelly, Asaf; Rosen, Gal; Meirowitz, Avi

2018-01-01

Dentists must be skilled when using dental mirrors. Working with mirrors requires spatial perception, bimanual coordination, perceptual learning and fine motor skills. Many studies have attempted to determine the predictors of manual skills among pre-clinical students, but consensus has yet to be reached. We hypothesized that valid and reliable occupational therapy test performance regarding indirect vision would differ between dental students and junior dentists and would explain the variance in manual skill performance in pre-clinical courses. To test this hypothesis, we applied the Purdue Pegboard test and O’Connor Tweezer Dexterity test under different conditions of direct and indirect vision. We administered these tests to students in phantom-head academic courses in 2015 and 2016 and to junior dentists. Students performed the tests at three time points: before phantom training (T0), at the end of the training (T1) and in the middle of the following year of study (T2). Dentists performed the same tests twice at 1st and 2nd trials one week apart. The results showed that indirect tasks were significantly more difficult to perform for both groups. These dexterity tests were sensitive enough to detect students’ improvement after phantom training. The dentists’ performances were significantly better than those of students at T0, specifically with regard to the use of tweezers under direct and indirect vision (the O’Connor test). A regression analysis showed that students’ manual grades obtained at the beginning of the phantom course, their performance on the Purdue test using both hands, and their performance on the O’Connor test under indirect vision predicted phantom course success in 80% of cases. The O’Connor test under indirect vision is the most informative means of monitoring and predicting the manual skills required in the pre-clinical year of dentistry studies. PMID:29518127

Superior Diagnostic Performance of Malaria Rapid Diagnostic Tests as compared to Blood Smears in U.S. Clinical Practice

PubMed Central

Stauffer, William M.; Cartwright, Charles P.; Olson, Douglas; Juni, Billie Anne; Taylor, Charlotte M; Bowers, Susan H.; Hanson, Kevan L.; Rosenblatt, Jon E.; Boulware, David R.

2010-01-01

Background Approximately 4 million U.S. travelers to developing countries are ill enough to seek healthcare with 1,500 malaria cases reported in the U.S. annually. The diagnosis of malaria is frequently delayed due to the time to prepare malaria blood films and lack of technical expertise. An easy, reliable rapid diagnostic test (RDT) with high sensitivity and negative predictive value (NPV), particularly for Plasmodium falciparum, would be clinically useful. The study objective was to determine the diagnostic performance of the FDA-approved NOW® Malaria Test in comparison to traditional thick and thin blood smears for malaria diagnosis. Methods This prospective study tested 852 consecutive blood samples sent for thick and thin smears with blinded, malaria rapid tests at three hospital laboratories during 2003–2006. Polymerase chain reaction (PCR) verified positive tests and discordant results. Results Malaria occurred in 11% (95/852). The rapid test had superior performance than the standard Giemsa thick blood smear (P=.003). The rapid test’s sensitivity for all malaria was 97% (92/95) vs. 85% (81/95) by blood smear, and the RDT had superior NPV of 99.6% vs. 98.2% (P=.001). The P. falciparum performance was excellent with 100% rapid test sensitivity versus only 88% (65/74) by blood smear (P=.003). Conclusions This operational study demonstrates the FDA-approved rapid malaria test is superior to a single set of blood smears performed under routine U.S. clinical laboratory conditions. The most valuable clinical role of the RDT is in the rapid diagnosis or the exclusion of P. falciparum malaria, which is particularly useful in outpatient settings when evaluating febrile travelers. PMID:19686072

Poor Positive Predictive Value of Lyme Disease Serologic Testing in an Area of Low Disease Incidence

PubMed Central

Lantos, Paul M.; Branda, John A.; Boggan, Joel C.; Chudgar, Saumil M.; Wilson, Elizabeth A.; Ruffin, Felicia; Fowler, Vance; Auwaerter, Paul G.; Nigrovic, Lise E.

2015-01-01

Background. Lyme disease is diagnosed by 2-tiered serologic testing in patients with a compatible clinical illness, but the significance of positive test results in low-prevalence regions has not been investigated. Methods. We reviewed the medical records of patients who tested positive for Lyme disease with standardized 2-tiered serologic testing between 2005 and 2010 at a single hospital system in a region with little endemic Lyme disease. Based on clinical findings, we calculated the positive predictive value of Lyme disease serology. Next, we reviewed the outcome of serologic testing in patients with select clinical syndromes compatible with disseminated Lyme disease (arthritis, cranial neuropathy, or meningitis). Results. During the 6-year study period 4723 patients were tested for Lyme disease, but only 76 (1.6%) had positive results by established laboratory criteria. Among 70 seropositive patients whose medical records were available for review, 12 (17%; 95% confidence interval, 9%–28%) were found to have Lyme disease (6 with documented travel to endemic regions). During the same time period, 297 patients with a clinical illness compatible with disseminated Lyme disease underwent 2-tiered serologic testing. Six of them (2%; 95% confidence interval, 0.7%–4.3%) were seropositive, 3 with documented travel and 1 who had an alternative diagnosis that explained the clinical findings. Conclusions. In this low-prevalence cohort, fewer than 20% of positive Lyme disease tests are obtained from patients with clinically likely Lyme disease. Positive Lyme disease test results may have little diagnostic value in this setting. PMID:26195017

Pediatric Allergic Contact Dermatitis: Clinical and Epidemiological Study in a Tertiary Hospital.

PubMed

Ortiz Salvador, J M; Esteve Martínez, A; Subiabre Ferrer, D; Victoria Martínez, A M; de la Cuadra Oyanguren, J; Zaragoza Ninet, V

Few epidemiological studies have investigated the incidence of allergic contact dermatitis in children. Underdiagnosis has been observed in some studies, with many cases in which the condition is not suspected clinically and patch tests are not performed. However, the prevalence of pediatric sensitization to allergens has been reported to be as high as 20%, and the diagnosis should therefore be contemplated as a possibility in this age group. We performed a retrospective analysis of the skin allergy database of the Dermatology Department of Consorcio Hospital General Universitario de Valencia. Children between 0 and 16 years of age diagnosed with allergic contact dermatitis in the previous 15 years (between 2000 and 2015) were included in the analysis. Epidemiological (age, sex, history of atopy) and clinical (site of the lesions, allergen series applied, positive reactions, and their relevance) variables were gathered. Patch tests had been performed on 4,593 patients during the study period. Of these, 265 (6%) were children aged between 0 and 16 years. A positive reaction to at least one of the allergens tested was observed in 144 (54.3%) patients in that group. The allergens most frequently identified were the following (in decreasing order of frequency): thiomersal, cobalt chloride, colophony, paraphenylenediamine, potassium dichromate, mercury, and nickel. The sensitization was considered relevant in 177 (61.3%) cases. More than half of the children studied showed sensitization to 1 or more allergens, with a high percentage of relevant sensitizations. All children with a clinical suspicion of allergic contact dermatitis should be referred for patch testing. As no standardized test series have been developed for this age group, a high level of clinical suspicion and knowledge of the allergens most commonly involved are required when selecting the allergens to be tested. Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

Posturography and locomotor tests of dynamic balance after long-duration spaceflight.

PubMed

Cohen, Helen S; Kimball, Kay T; Mulavara, Ajitkumar P; Bloomberg, Jacob J; Paloski, William H

2012-01-01

The currently approved objective clinical measure of standing balance in astronauts after space flight is the Sensory Organization Test battery of computerized dynamic posturography. No tests of walking balance are currently approved for standard clinical testing of astronauts. This study determined the sensitivity and specificity of standing and walking balance tests for astronauts before and after long-duration space flight. Astronauts were tested on an obstacle avoidance test known as the Functional Mobility Test (FMT) and on the Sensory Organization Test using sway-referenced support surface motion with eyes closed (SOT 5) before and six months after (n=15) space flight on the International Space Station. They were tested two to seven days after landing. Scores on SOT tests decreased and scores on FMT increased significantly from pre- to post-flight. In other words, post-flight scores were worse than pre-flight scores. SOT and FMT scores were not significantly related. ROC analyses indicated supra-clinical cut-points for SOT 5 and for FMT. The standard clinical cut-point for SOT 5 had low sensitivity to post-flight astronauts. Higher cut-points increased sensitivity to post-flight astronauts but decreased specificity to pre-flight astronauts. Using an FMT cut-point that was moderately highly sensitive and highly specific plus SOT 5 at the standard clinical cut-point was no more sensitive than SOT 5, alone. FMT plus SOT 5 at higher cut-points was more specific and more sensitive. The total correctly classified was highest for FMT, alone, and for FMT plus SOT 5 at the highest cut-point. These findings indicate that standard clinical comparisons are not useful for identifying problems. Testing both standing and walking balance will be more likely to identify balance deficits.

Public health and clinical impact of increasing emergency department-based HIV testing: perspectives from the 2007 conference of the National Emergency Department HIV Testing Consortium.

PubMed

Kecojevic, Aleksandar; Lindsell, Christopher J; Lyons, Michael S; Holtgrave, David; Torres, Gretchen; Heffelfinger, James; Brown, Jeremy; Couture, Eileen; Jung, Julianna; Connell, Samantha; Rothman, Richard E

2011-07-01

Understanding perceived benefits and disadvantages of HIV testing in emergency departments (EDs) is imperative to overcoming barriers to implementation. We codify those domains of public health and clinical care most affected by implementing HIV testing in EDs, as determined by expert opinion. Opinions were systematically collected from attendees of the 2007 National ED HIV Testing Consortium meeting. Structured evaluation of strengths, weaknesses, opportunities, and threats analysis was conducted to assess the impact of ED-based HIV testing on public health. A modified Delphi method was used to assess the impact of ED-based HIV testing on clinical care from both individual patient and individual provider perspectives. Opinions were provided by 98 experts representing 42 academic and nonacademic institutions. Factors most frequently perceived to affect public health were (strengths) high volume of ED visits and high prevalence of HIV, (weaknesses) undue burden on EDs, (opportunities) reduction of HIV stigma, and (threats) lack of resources in EDs. Diagnostic testing and screening for HIV were considered to have a favorable impact on ED clinical care from both individual patient and individual provider perspectives; however, negative test results were not perceived to have any benefit from the provider's perspective. The need for HIV counseling in the ED was considered to have a negative impact on clinical care from the provider's perspective. Experts in ED-based HIV testing perceived expanded ED HIV testing to have beneficial impacts for both the public health and individual clinical care; however, limited resources were frequently cited as a possible impediment. Many issues must be resolved through further study, education, and policy changes if the full potential of HIV testing in EDs is to be realized. Copyright © 2011. Published by Mosby, Inc.

Differentiating clinical groups using the serial color-word test (S-CWT).

PubMed

Hentschel, Uwe; Rubino, I Alex; Bijleveld, Catrien

2011-04-01

The present study attempted to differentiate 11 diagnostic groups by means of the Serial Color-Word Test (S-CWT), using multivariate discriminant analysis. Two alternative scoring systems of the S-CWT were outlined. Asample of 514 individuals who had clinical diagnoses of various types and 397 controls who had no diagnostic findings comprised the sample. The first discriminant analysis failed to differentiate the groups adequately. The groups were consequently reduced to four (schizophrenia, bipolar disorders, temporo-mandibular joint pain dysfunction syndrome, and eating disturbances), which gave better reclassification findings for a clinical application of the test. This classification gave over 55% correct assignments. The final four groups had a statistically significant discrimination on the test, which remained stable also in a bootstrap procedure. Implications for treatment indications and outcomes as well as strategies for further studies using the S-CWT are discussed.

The Brain Health Registry: An internet-based platform for recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies.

PubMed

Weiner, Michael W; Nosheny, Rachel; Camacho, Monica; Truran-Sacrey, Diana; Mackin, R Scott; Flenniken, Derek; Ulbricht, Aaron; Insel, Philip; Finley, Shannon; Fockler, Juliet; Veitch, Dallas

2018-05-08

Recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies and clinical trials limit the development of new treatments. Widespread Internet use allows data capture from participants in an unsupervised setting. The Brain Health Registry, a website and online registry, collects data from participants and their study partners. The Brain Health Registry obtains self and study partner report questionnaires and neuropsychological data, including the Cogstate Brief Battery, Lumos Labs Neurocognitive Performance Test, and MemTrax Memory Test. Participants provide informed consent before participation. Baseline and longitudinal data were obtained from nearly 57,000 and 28,000 participants, respectively. Over 18,800 participants were referred to, and nearly 1800 were enrolled in, clinical Alzheimer's disease and aging studies, including five observational studies and seven intervention trials. Online assessments of participants and study partners provide useful information at relatively low cost for neuroscience studies and clinical trials and may ultimately be used in routine clinical practice. Copyright © 2018 the Alzheimer's Association. All rights reserved.

Safety and clinical performance of acoustic reflex tests.

PubMed

Hunter, L L; Ries, D T; Schlauch, R S; Levine, S C; Ward, W D

1999-12-01

Safety and effectiveness of acoustic reflex tests are important issues because these tests are widely applied to screen for retrocochlear pathology. Previous studies have reported moderately high sensitivity and specificity for detection of acoustic neuroma. However, there have been reports of possible iatrogenic hearing loss resulting from acoustic reflex threshold (ART) and decay (ARD) tests. This study assessed safety and clinical performance of ART tests for detection of acoustic neuroma. We report a case in which ARD testing resulted in a significant bilateral permanent threshold shift. This case was the impetus for us to investigate the clinical utility of ART and ARD tests. We analyzed sensitivity and specificity of ART, as well as asymmetry in pure-tone thresholds (PTT) for detection of acoustic neuroma in 56 tumor and 108 non-tumor ears. Sensitivity and specificity were higher for PTT asymmetry than for ART. Ipsilateral ART at 1000 Hz had poor sensitivity and specificity for detection of acoustic neuroma, and involves some potential risk to residual hearing for presentation levels higher than 115 dB SPL. Approximately half of the acoustic neuroma group had ipsilateral ARTs that would require administration of ARD tests at levels exceeding 115 dB SPL. Therefore, we conclude that PTT asymmetry is a more effective test for detection of acoustic neuroma, and involves no risk to residual hearing. Future studies of contralateral reflex threshold and ARD in combination with PTT asymmetry are recommended.

Clinical Applications of Gastrointestinal Manometry in Children

PubMed Central

2014-01-01

Manometry is a noninvasive diagnostic tool for identifying motility dysfunction of the gastrointestinal tract. Despite the great technical advances in monitoring motility, performance of the study in pediatric patients has several limitations that should be considered during the procedure and interpretation of the test results. This article reviews the clinical applications of conventional esophageal and anorectal manometries in children by describing a technique for performing the test. This review will develop the uniformity required for the methods of performance, the parameters for measurement, and interpretation of test results that could be applied in pediatric clinical practice. PMID:24749084

Physical examination tests of the shoulder: a systematic review and meta-analysis of diagnostic test performance.

PubMed

Gismervik, Sigmund Ø; Drogset, Jon O; Granviken, Fredrik; Rø, Magne; Leivseth, Gunnar

2017-01-25

Physical examination tests of the shoulder (PETS) are clinical examination maneuvers designed to aid the assessment of shoulder complaints. Despite more than 180 PETS described in the literature, evidence of their validity and usefulness in diagnosing the shoulder is questioned. This meta-analysis aims to use diagnostic odds ratio (DOR) to evaluate how much PETS shift overall probability and to rank the test performance of single PETS in order to aid the clinician's choice of which tests to use. This study adheres to the principles outlined in the Cochrane guidelines and the PRISMA statement. A fixed effect model was used to assess the overall diagnostic validity of PETS by pooling DOR for different PETS with similar biomechanical rationale when possible. Single PETS were assessed and ranked by DOR. Clinical performance was assessed by sensitivity, specificity, accuracy and likelihood ratio. Six thousand nine-hundred abstracts and 202 full-text articles were assessed for eligibility; 20 articles were eligible and data from 11 articles could be included in the meta-analysis. All PETS for SLAP (superior labral anterior posterior) lesions pooled gave a DOR of 1.38 [1.13, 1.69]. The Supraspinatus test for any full thickness rotator cuff tear obtained the highest DOR of 9.24 (sensitivity was 0.74, specificity 0.77). Compression-Rotation test obtained the highest DOR (6.36) among single PETS for SLAP lesions (sensitivity 0.43, specificity 0.89) and Hawkins test obtained the highest DOR (2.86) for impingement syndrome (sensitivity 0.58, specificity 0.67). No single PETS showed superior clinical test performance. The clinical performance of single PETS is limited. However, when the different PETS for SLAP lesions were pooled, we found a statistical significant change in post-test probability indicating an overall statistical validity. We suggest that clinicians choose their PETS among those with the highest pooled DOR and to assess validity to their own specific clinical settings, review the inclusion criteria of the included primary studies. We further propose that future studies on the validity of PETS use randomized research designs rather than the accuracy design relying less on well-established gold standard reference tests and efficient treatment options.

A proof of concept study to assess the potential of PCR testing to detect natural Mycobacterium bovis infection in South American camelids

PubMed Central

2014-01-01

Background Cases of Mycobacterium bovis infection South American camelids have been increasing in Great Britain. Current antemortem immunological tests have some limitations. Cases at post mortem examination frequently show extensive pathology. The feasibility of detecting Mycobacterium bovis DNA in clinical samples was investigated. Findings A sensitive extraction methodology was developed and used on nasal swabs and faeces taken post-mortem to assess the potential for a PCR test to detect Mycobacterium bovis in clinical samples. The gross pathology of the studied South American camelids was scored and a significantly greater proportion of South American camelids with more severe pathology were positive in both the nasal swab and faecal PCR tests. A combination of the nasal swab and faecal PCR tests detected 63.9% of all the South American camelids with pathology that were tested. Conclusions The results suggest that antemortem diagnosis of Mycobacterium bovis in South American camelids may be possible using a PCR test on clinical samples, however more work is required to determine sensitivity and specificity, and the practicalities of applying the test in the field. PMID:24507471

Adjusted regression trend test for a multicenter clinical trial.

PubMed

Quan, H; Capizzi, T

1999-06-01

Studies using a series of increasing doses of a compound, including a zero dose control, are often conducted to study the effect of the compound on the response of interest. For a one-way design, Tukey et al. (1985, Biometrics 41, 295-301) suggested assessing trend by examining the slopes of regression lines under arithmetic, ordinal, and arithmetic-logarithmic dose scalings. They reported the smallest p-value for the three significance tests on the three slopes for safety assessments. Capizzi et al. (1992, Biometrical Journal 34, 275-289) suggested an adjusted trend test, which adjusts the p-value using a trivariate t-distribution, the joint distribution of the three slope estimators. In this paper, we propose an adjusted regression trend test suitable for two-way designs, particularly for multicenter clinical trials. In a step-down fashion, the proposed trend test can be applied to a multicenter clinical trial to compare each dose with the control. This sequential procedure is a closed testing procedure for a trend alternative. Therefore, it adjusts p-values and maintains experimentwise error rate. Simulation results show that the step-down trend test is overall more powerful than a step-down least significant difference test.

Value analysis of postoperative staging imaging for asymptomatic, early-stage breast cancer: implications of clinical variation on utility and cost.

PubMed

Pellet, Andrew C; Erten, Mujde Z; James, Ted A

2016-06-01

Routine staging imaging for early-stage breast cancer is not recommended. Despite this, there is clinical practice variation with imaging studies obtained for asymptomatic patients with a positive sentinel node (SN+). We characterize the utility, cost, and clinical implications of imaging studies obtained in asymptomatic SN+ patients. A retrospective review was performed of asymptomatic, clinically node-negative patients who were found to have a positive sentinel node after surgery. The type of imaging, subsequent tests/interventions, frequency of additional malignancy detected, and costs were recorded. From April 2009 to April 2013, a total of 50 of 113 (44%) asymptomatic patients underwent staging imaging for a positive sentinel node; 11 (22%) patients had at least 1 subsequent imaging study or diagnostic intervention. No instance of metastatic breast cancer was identified, with a total cost of imaging calculated at $116,905. Staging imaging for asymptomatic SN+ breast cancer demonstrates clinical variation. These tests were associated with low utility, increased costs, and frequent false positives leading to subsequent testing/intervention. Evidence-based standardization may help increase quality by decreasing unnecessary variation and cost. Copyright © 2015 Elsevier Inc. All rights reserved.

The Clinical Delivery of Pharmacogenetic Testing Services: A Proposed Partnership between Genetic Counselors and Pharmacists

PubMed Central

Mills, Rachel; Haga, Susanne B.

2013-01-01

One of the basic questions in the early uses of pharmacogenetic (PGx) testing revolves around the clinical delivery of testing. Because multiple health professionals may play a role in the delivery of PGx testing, various clinical delivery models have begun to be studied. We propose that a partnership between genetic counselors and pharmacists can assist clinicians in the delivery of comprehensive PGx services. Based on their expert knowledge of pharmacokinetics and pharmacodynamics, pharmacists can facilitate the appropriate application of PGx test results to adjust medication use as warranted and act as a liaison to the healthcare team recommending changes in medication based on test results and patient input. Genetic counselors are well-trained in genetics as well as risk communication and counseling methodology, but have limited knowledge of pharmaceuticals. The complementary knowledge and skill set supports the partnership between genetic counselors and pharmacists to provide effective PGx testing services. PMID:23746189

Clinical Tests Combined with Color Doppler Versus Color Doppler Alone in Identifying Incompetent Perforator Veins of the Lower Limb: A Prospective Analytical Study.

PubMed

Sureshkumar, Sathasivam; Vignesh, Narayan; Venkatachalam, J; Vijayakumar, Chellappa; Sudharsanan, Sundaramurthi

2018-01-05

Background The color Doppler, a better investigation to identify the perforators objectively has replaced the clinical examination for the same. However, this has led to a significant number of negative explorations and cosmetic disfigurement. Objective To compare the efficacy of the clinical tests combined with the color Doppler versus color Doppler alone to identify the perforator incompetence during the surgery for primary varicose veins of the lower limb. Methods This was a prospective analytical study, including 61 lower limb varicose vein patients who belonged to the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) class four-six, planned for the surgical treatment for perforator incompetence, excluding those requiring additional vascular or nonvascular procedure, recurrent varicose veins and those who had injection sclerotherapy prior to the surgery. The clinical tests, including Trendelenburg's test, multiple tourniquet tests and, the Fegan's tests were performed and incompetent perforators were marked on a template as 'C' to indicate the clinically positive perforator incompetence. The patients were then examined with the color Doppler ultrasound and the pathological incompetent perforators were marked as 'D'. The surgical management of the perforator incompetence was done by stab ligation. The incision was made in the color Doppler 'D' marked sites as it has been the standard protocol. The number of incompetent perforators identified during the surgical exploration were categorized as 'D' positive or 'C' and 'D' positive and were recorded in the specified proforma. Results It was found that the mean number of the perforator incompetence identified by the color Doppler alone was 8.2 whereas during the surgery, only a mean of six perforators was identified, leading to 20 unnecessary explorations per 10 patients (8.2 vs. 6; mean difference 2.229; P <0.001). The mean number of the perforator incompetence identified by the color Doppler combined with the clinical tests was 4.5 and during the surgery, a mean of four perforators was identified (4.5 vs. 4; mean difference 0.377; P <0.001). The color Doppler combined with the clinical examination lead to only four unnecessary explorations per 10 patients. Conclusion A combination of both the clinical tests and the color Doppler ultrasound has a higher accuracy in detecting perforator incompetence and can reduce the number of negative explorations by the rate of 16 unnecessary explorations per 10 patients.

Can physical joint simulators be used to anticipate clinical wear problems of new joint replacement implants prior to market release?

PubMed

Medley, John B

2016-05-01

One of the most important mandates of physical joint simulators is to provide test results that allow the implant manufacturer to anticipate and perhaps avoid clinical wear problems with their new products. This is best done before market release. This study gives four steps to follow in conducting such wear simulator testing. Two major examples involving hip wear simulators are discussed in which attempts had been made to predict clinical wear performance prior to market release. The second one, involving the DePuy ASR implant systems, is chosen for more extensive treatment by making it an illustrative example to explore whether wear simulator testing can anticipate clinical wear problems. It is concluded that hip wear simulator testing did provide data in the academic literature that indicated some risk of clinical wear problems prior to market release of the ASR implant systems. This supports the idea that physical joint simulators have an important role in the pre-market testing of new joint replacement implants. © IMechE 2016.

The diagnostic accuracy of serological tests for Lyme borreliosis in Europe: a systematic review and meta-analysis.

PubMed

Leeflang, M M G; Ang, C W; Berkhout, J; Bijlmer, H A; Van Bortel, W; Brandenburg, A H; Van Burgel, N D; Van Dam, A P; Dessau, R B; Fingerle, V; Hovius, J W R; Jaulhac, B; Meijer, B; Van Pelt, W; Schellekens, J F P; Spijker, R; Stelma, F F; Stanek, G; Verduyn-Lunel, F; Zeller, H; Sprong, H

2016-03-25

Interpretation of serological assays in Lyme borreliosis requires an understanding of the clinical indications and the limitations of the currently available tests. We therefore systematically reviewed the accuracy of serological tests for the diagnosis of Lyme borreliosis in Europe. We searched EMBASE en MEDLINE and contacted experts. Studies evaluating the diagnostic accuracy of serological assays for Lyme borreliosis in Europe were eligible. Study selection and data-extraction were done by two authors independently. We assessed study quality using the QUADAS-2 checklist. We used a hierarchical summary ROC meta-regression method for the meta-analyses. Potential sources of heterogeneity were test-type, commercial or in-house, Ig-type, antigen type and study quality. These were added as covariates to the model, to assess their effect on test accuracy. Seventy-eight studies evaluating an Enzyme-Linked ImmunoSorbent assay (ELISA) or an immunoblot assay against a reference standard of clinical criteria were included. None of the studies had low risk of bias for all QUADAS-2 domains. Sensitivity was highly heterogeneous, with summary estimates: erythema migrans 50% (95% CI 40% to 61%); neuroborreliosis 77% (95% CI 67% to 85%); acrodermatitis chronica atrophicans 97% (95% CI 94% to 99%); unspecified Lyme borreliosis 73% (95% CI 53% to 87%). Specificity was around 95% in studies with healthy controls, but around 80% in cross-sectional studies. Two-tiered algorithms or antibody indices did not outperform single test approaches. The observed heterogeneity and risk of bias complicate the extrapolation of our results to clinical practice. The usefulness of the serological tests for Lyme disease depends on the pre-test probability and subsequent predictive values in the setting where the tests are being used. Future diagnostic accuracy studies should be prospectively planned cross-sectional studies, done in settings where the test will be used in practice.

Predicting Performance during Clinical Years from the New Medical College Admission Test.

ERIC Educational Resources Information Center

Caroline, Jan D.; And Others

1983-01-01

The results of a predictive validity study of the new Medical College Admission Test (MCAT) using criteria from the clinical years of undergraduate medical education are discussed. The criteria included course grades and faculty ratings of clerks in internal medicine, surgery, obstetrics and gynecology, pediatrics, and psychiatry. (Author/MLW)

Impact of clinical teaching on students knowledge acquisition.

PubMed

Manzar, Shabih

2003-08-01

We are in the process of curriculum revision and for that we need to know the strengths and weaknesses of the current teaching program and the venue that may need more attention. To proceed with this aim, we conducted this study. The study was conducted on 2 groups of students rotating through nursery as a part of Pediatrics clerkship at King Faisal University, Dammam, KSA, during a 2 month study, April through to May 2001. A 15 item questionnaire was developed for testing. By using a pre-test post-test model, we looked at the scores achieved by the students on the questionnaire before and after 2 weeks of intensive clinical teaching. In the first group of students, the mean percentage of correctly answered questions were higher in the post-test (78%) as compared to pre-test (64%), which was statistically significant, p=0.02. A similar trend was noted in the second group, the mean percentage of correctly answered questions were higher in the post-test (64%) as compared to pre-test (78%), which was also statistically significant, p=0.004. We concluded that our method of clinical teaching followed during nursery rotation was effective in increasing students knowledge. However, attention is needed on some topics in which students are noted to be relatively weak.

Clinical Tests Have Limited Predictive Value for Chronic Ankle Instability When Conducted in the Acute Phase of a First-Time Lateral Ankle Sprain Injury.

PubMed

Doherty, Cailbhe; Bleakley, Chris; Hertel, Jay; Caulfield, Brian; Ryan, John; Delahunt, Eamonn

2018-04-01

To evaluate whether a battery of clinical assessments for acute lateral ankle sprain (LAS) can be used to predict long-term recovery. Cohort study. University biomechanics laboratory. Individuals (N=82) were assessed using a clinical test battery within 2 weeks of incurring a first-time LAS. Not applicable. The clinical test battery included scores on the talar glide test (degrees), the anterior drawer, talar tilt, figure of 8 for swelling (millimeters) and knee to wall (millimeters) tests, and handheld goniometric range of motion (inversion, eversion, and plantarflexion [in degrees]). Scores on the Cumberland Ankle Instability Tool taken 12 months after the clinical test battery were used to classify participants as having chronic ankle instability (CAI) or as being LAS copers. Forty percent of participants were designated as having CAI, with 60% being designated as LAS copers. A logistic regression analysis revealed that a combined model using scores from the talar glide, talar tilt, and anterior drawer tests in addition to plantarflexion range of motion was statistically significant (P<.01) and correctly classified cases with moderate accuracy (68.8%). The final model had moderate sensitivity (64%) and good specificity (72%). The clinical tests used in this investigation have limited predictive value for CAI when conducted in the acute phase of a first-time LAS injury. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Overdiagnosis across medical disciplines: a scoping review.

PubMed

Jenniskens, Kevin; de Groot, Joris A H; Reitsma, Johannes B; Moons, Karel G M; Hooft, Lotty; Naaktgeboren, Christiana A

2017-12-27

To provide insight into how and in what clinical fields overdiagnosis is studied and give directions for further applied and methodological research. Scoping review. Medline up to August 2017. All English studies on humans, in which overdiagnosis was discussed as a dominant theme. Studies were assessed on clinical field, study aim (ie, methodological or non-methodological), article type (eg, primary study, review), the type and role of diagnostic test(s) studied and the context in which these studies discussed overdiagnosis. From 4896 studies, 1851 were included for analysis. Half of all studies on overdiagnosis were performed in the field of oncology (50%). Other prevalent clinical fields included mental disorders, infectious diseases and cardiovascular diseases accounting for 9%, 8% and 6% of studies, respectively. Overdiagnosis was addressed from a methodological perspective in 20% of studies. Primary studies were the most common article type (58%). The type of diagnostic tests most commonly studied were imaging tests (32%), although these were predominantly seen in oncology and cardiovascular disease (84%). Diagnostic tests were studied in a screening setting in 43% of all studies, but as high as 75% of all oncological studies. The context in which studies addressed overdiagnosis related most frequently to its estimation, accounting for 53%. Methodology on overdiagnosis estimation and definition provided a source for extensive discussion. Other contexts of discussion included definition of disease, overdiagnosis communication, trends in increasing disease prevalence, drivers and consequences of overdiagnosis, incidental findings and genomics. Overdiagnosis is discussed across virtually all clinical fields and in different contexts. The variability in characteristics between studies and lack of consensus on overdiagnosis definition indicate the need for a uniform typology to improve coherence and comparability of studies on overdiagnosis. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Asthma in pregnancy: association between the Asthma Control Test and the Global Initiative for Asthma classification and comparisons with spirometry.

PubMed

de Araujo, Georgia Véras; Leite, Débora F B; Rizzo, José A; Sarinho, Emanuel S C

2016-08-01

The aim of this study was to identify a possible association between the assessment of clinical asthma control using the Asthma Control Test (ACT) and the Global Initiative for Asthma (GINA) classification and to perform comparisons with values of spirometry. Through this cross-sectional study, 103 pregnant women with asthma were assessed in the period from October 2010 to October 2013 in the asthma pregnancy clinic at the Clinical Hospital of the Federal University of Pernambuco. Questionnaires concerning the level of asthma control were administered using the Global Initiative for Asthma classification, the Asthma Control Test validated for asthmatic expectant mothers and spirometry; all three methods of assessing asthma control were performed during the same visit between the twenty-first and twenty-seventh weeks of pregnancy. There was a significant association between clinical asthma control assessment using the Asthma Control Test and the Global Initiative for Asthma classification (p<0.001). There were also significant associations between the results of the subjective instruments of asthma (the GINA classification and the ACT) and evidence of lung function by spirometry. This study shows that both the Global Initiative for Asthma classification and the Asthma Control Test can be used for asthmatic expectant mothers to assess the clinical control of asthma, especially at the end of the second trimester, which is assumed to be the period of worsening asthma exacerbations during pregnancy. We highlight the importance of the Asthma Control Test as a subjective instrument with easy application, easy interpretation and good reproducibility that does not require spirometry to assess the level of asthma control and can be used in the primary care of asthmatic expectant mothers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of problem based learning as an instructional tool for acquisition of content knowledge and promotion of critical thinking among medical students.

PubMed

Tayyeb, Rakhshanda

2013-01-01

To assess effectiveness of PBL as an instructional tool in clinical years to improve learning of undergraduate students in terms of acquisition of content knowledge, critical thinking and problem solving skills through problem based learning and traditional way of teaching. Quasi-experimental study. Fatima Jinnah Medical College for Women, Lahore, from October 2009 to April 2010. Final year medical students attending Obstetrics and Gynaecology and Surgery rotations were inducted as participants in this study. Two batches of 50 students each attended Gynaecology rotation and two batches attended Surgery rotation, i.e. 100 students in each. Each batch was divided into two groups i.e. A and B of 25 students each. Group-A learnt through traditional teaching, involving bedside teaching and lectures in wards and Group-B learnt relevant clinical knowledge through a modified PBL process. Content knowledge was tested by MCQs testing recall while clinical reasoning and problem were assessed by MCQs testing analysis and critical thinking. Intra-group comparison of mean scores of pre and post-test scores was done using paired sample t-tests while for intergroup comparison of mean scores was done through independent sample t-test. Teaching through traditional method significantly improved content knowledge, (p = 0.001) but did not considerably improve clinical reasoning and problem solving skills (p = 0.093) whereas, content knowledge of students who studied through PBL remained the same (p = 0.202) but there was marked improvement in their clinical reasoning and problem solving skills (p = < 0.001). PBL is an effective instructional tool to foster critical thinking and problem solving skills among medical students.

Optimization and evaluation of Flexicult® Vet for detection, identification and antimicrobial susceptibility testing of bacterial uropathogens in small animal veterinary practice.

PubMed

Guardabassi, Luca; Hedberg, Sandra; Jessen, Lisbeth Rem; Damborg, Peter

2015-10-26

Urinary tract infection (UTI) is a common reason for antimicrobial prescription in dogs and cats. The objective of this study was to optimize and evaluate a culture-based point-of-care test for detection, identification and antimicrobial susceptibility testing of bacterial uro-pathogens in veterinary practice. Seventy-two urine samples from dogs and cats with suspected UTI presenting to seven veterinary facilities were used by clinical staff and an investigator to estimate sensitivity and specificity of Flexicult Vet A compared to laboratory reference standards for culture and susceptibility testing. Subsequently, the test was modified by inclusion of an oxacillin-containing compartment for detection of methicillin-resistant staphylococci. The performance of the modified product (Flexicult Vet B) for susceptibility testing was evaluated in vitro using a collection of 110 clinical isolates. Bacteriuria was reported by the laboratory in 25 (35 %) samples from the field study. The sensitivity and specificity of Flexicult Vet A for detection of bacteriuria were 83 and 100 %, respectively. Bacterial species were correctly identified in 53 and 100 % of the positive samples by clinical staff and the investigator, respectively. The susceptibility results were interpreted correctly by clinical staff for 70 % of the 94 drug-strain combinations. Higher percentages of correct interpretation were observed when the results were interpreted by the investigator in both the field (76 %) and the in vitro study (94 %). The most frequent errors were false resistance to β-lactams (ampicillin, amoxicillin-clavulanate and cephalotin) in Escherichia coli for Flexicult Vet A, and false amoxicillin-clavulanate resistance in E. coli and false ampicillin susceptibility in Staphylococcus pseudintermedius for Flexicult Vet B. The latter error can be prevented by categorizing staphylococcal strains growing in the oxacillin compartment as resistant to all β-lactams. Despite the shortcomings regarding species identification by clinical staff and β-lactam susceptibility testing of E. coli, Flexicult Vet B (commercial name Flexicult(®) Vet) is a time- and cost-effective point-of-care test to guide antimicrobial choice and facilitate implementation of antimicrobial use guidelines for treatment of UTIs in small animals, provided that clinical staff is adequately trained to interpret the results and that clinics meet minimum standards to operate in-house culture.

Psychometric characteristics of Clinical Reasoning Problems (CRPs) and its correlation with routine multiple choice question (MCQ) in Cardiology department

PubMed Central

DERAKHSHANDEH, ZAHRA; AMINI, MITRA; KOJURI, JAVAD; DEHBOZORGIAN, MARZIYEH

2018-01-01

Introduction: Clinical reasoning is one of the most important skills in the process of training a medical student to become an efficient physician. Assessment of the reasoning skills in a medical school program is important to direct students’ learning. One of the tests for measuring the clinical reasoning ability is Clinical Reasoning Problems (CRPs). The major aim of this study is to measure psychometric qualities of CRPs and define correlation between this test and routine MCQ in cardiology department of Shiraz medical school. Methods: This study was a descriptive study conducted on total cardiology residents of Shiraz Medical School. The study population consists of 40 residents in 2014. The routine CRPs and the MCQ tests was designed based on similar objectives and were carried out simultaneously. Reliability, item difficulty, item discrimination, and correlation between each item and the total score of CRPs were all measured by Excel and SPSS software for checking psycometeric CRPs test. Furthermore, we calculated the correlation between CRPs test and MCQ test. The mean differences of CRPs test score between residents’ academic year [second, third and fourth year] were also evaluated by Analysis of variances test (One Way ANOVA) using SPSS software (version 20)(α=0.05). Results: The mean and standard deviation of score in CRPs was 10.19 ±3.39 out of 20; in MCQ, it was 13.15±3.81 out of 20. Item difficulty was in the range of 0.27-0.72; item discrimination was 0.30-0.75 with question No.3 being the exception (that was 0.24). The correlation between each item and the total score of CRP was 0.26-0.87; the correlation between CRPs test and MCQ test was 0.68 (p<0.001). The reliability of the CRPs was 0.72 as calculated by using Cronbach's alpha. The mean score of CRPs was different among residents based on their academic year and this difference was statistically significant (p<0.001). Conclusion: The results of this present investigation revealed that CRPs could be reliable test for measuring clinical reasoning in residents. It can be included in cardiology residency assessment programs. PMID:29344528

[Laboratory diagnosis of genital herpes--direct immunofluorescence method].

PubMed

Majewska, Anna; Romejko-Wolniewicz, Ewa; Zareba-Szczudlik, Julia; Kilijańczyk, Marek; Gajewska, Małgorzata; Młynarczyk, Grazyna

2013-07-01

Aim of the study was to determine clinical usefulness of direct immunofluorescence method in the laboratory diagnosis of genital herpes in women. Overall 187 anogenital swabs were collected from 120 women. Using a dacron-tipped applicator 83 swabs were collected from women suspected of genital herpes and 104 from patients with no signs of genital infection. All samples were tested using cell culture (Vero cell line) and then direct immunofluorescence method (DIF) for the identification of antigens of herpes simplex viruses: HSV-1 and HSV-2. Characteristic cytopathic effect (CPE), indicative of alphaherpesvirus infection, was observed in 43.4% of cultures with clinical specimens collected from women with suspected genital herpes and in 29.8% of cultures of clinical specimens taken from patients with no clinical symptoms of genital herpes. Herpes simplex viruses were determined in 73 samples by direct immunofluorescence method after amplification of the virus in cell culture. The DIF test confirmed the diagnosis based on the microscopic CPE observation in 85%. In 15% of samples (taken from pregnant women without clinical signs of infection) we reported positive immunofluorescence in the absence of CPE. The frequency of antigen detection was statistically significantly higher in samples that were positive by culture study (chi-square test with Yates's correction, p < 0.01). This method proved to be highly sensitive (97%) in women with clinically suspected infection. High negative predictive value (99%) proves the clinical utility of the DIF in these group of patients. In asymptomatic infections, viral antigens were detected most frequently in the swabs from the cervical canal, and in cases of suspected genital herpes in swabs taken from the vestibule of the vagina and the vulva. However, there was no statistically significant difference in the frequency of detection of Herpes Simplex Virus antigens in specimens from different parts of the genital tract in both groups of women (chi-square test, p > 0.05). In our study HHV-1 was the main causative agent of genital herpes. The growing worldwide prevalence of genital herpes, challenges with the clinical diagnosis, and availability of effective antiviral therapy are the main reasons for a growing interest in rapid, proper laboratory diagnosis of infected patients. Optimal testing diagnostic algorithm depends on patient population, clinical circumstances and availability. Our results indicated that combination of laboratory tests may help to establish the diagnosis if genital herpes is suspected but there are no typical signs.

A mixed methods study to assess the feasibility of a randomised controlled trial of invasive urodynamic testing versus clinical assessment and non-invasive tests prior to surgery for stress urinary incontinence in women: the INVESTIGATE-I study.

PubMed

Hilton, Paul; Armstrong, Natalie; Brennand, Catherine; Howel, Denise; Shen, Jing; Bryant, Andrew; Tincello, Douglas G; Lucas, Malcolm G; Buckley, Brian S; Chapple, Christopher R; Homer, Tara; Vale, Luke; McColl, Elaine

2015-09-08

The position of invasive urodynamic testing (IUT) in diagnostic pathways for urinary incontinence is unclear, and systematic reviews have called for further trials evaluating clinical utility. The objective of this study was to inform the decision whether to proceed to a definitive randomised trial of IUT compared to clinical assessment with non-invasive tests, prior to surgery in women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI). A mixed methods study comprising a pragmatic multicentre randomised pilot trial, a qualitative face-to face interview study with patients eligible for the trial, an exploratory economic evaluation including value of information study, a survey of clinicians' views about IUT, and qualitative telephone interviews with purposively sampled survey respondents. Only the first and second of these elements are reported here. Trial participants were randomised to either clinical assessment with non-invasive tests (control arm) or clinical assessment with non-invasive tests plus IUT (intervention arm). The main outcome measures of these feasibility studies were confirmation that units can identify and recruit eligible women, acceptability of investigation strategies and data collection tools, and acquisition of outcome data to determine the sample size for a definitive trial. The primary outcome proposed for a definitive trial was ICIQ-FLUTS (total score) 6 months after surgery or the start of nonsurgical treatment. Of 284 eligible women, 222 (78%) were recruited, 165/219 (75%) returned questionnaires at baseline, and 125/200 returned them (63%) at follow-up. Most women underwent surgery; management plans were changed in 19 (19%) participants following IUT. Participants interviewed were positive about the trial and the associated documentation. All elements of a definitive trial were rehearsed. Such a trial would require between 232 and 922 participants, depending on the target difference in the primary outcome. We identified possible modifications to our protocol for application in a definitive trial including clarity over inclusion/exclusions, screening processes, reduction in secondary outcomes, and modification to patient questionnaire booklets and bladder diaries. A definitive trial of IUT versus clinical assessment prior to surgery for SUI or stress predominant MUI is feasible and remains relevant. Current Controlled Trials: ISRCTN 71327395, registered 7 June 2010.

Knowledge and Practices of Toxoplasmosis among Clinical Laboratory Professionals: A Cross-Sectional Study in Durango, Mexico

PubMed Central

Sánchez-Anguiano, Luis Francisco; Berumen-Segovia, Luis Omar; Hernández-Tinoco, Jesús; Rico-Almochantaf, Yazmin del Rosario; Cisneros-Camacho, Alfredo; Cisneros-Martínez, Jorge Arturo

2017-01-01

Background: The aim of this study was to determine the level of knowledge and practices about toxoplasmosis in a sample of clinical laboratory professionals in Mexico. Methods: 192 clinical laboratory professionals were surveyed. They were asked about (1) Toxoplasma gondii; (2) clinical manifestations, diagnosis, treatment, and epidemiology of toxoplasmosis; and (3) their practices with respect to toxoplasmosis. Results: The range of animals infected by T. gondii was known by 44.8% of participants. Clinical aspects of toxoplasmosis were known by up to 44.3% of subjects. Correct answers about the interpretation of serological markers of T. gondii infection were provided by up to 32.8% of participants. A minority (32.2%) of participants knew about a high number of false positive results of anti-T. gondii IgM antibody tests. Most participants (90.1%) did not know what the anti-T. gondii IgG avidity test was. Up to 55.7% of participants provided incorrect answers about the interpretation of serology tests for the treatment of pregnant women. Common routes of T. gondii infection were known by <15% of participants. Most (84.4%) participants had not performed tests for detection T. gondii infection. Conclusions: Results indicate incomplete knowledge of T. gondii infection and toxoplasmosis and a limited practice of laboratory tests among the professionals surveyed. PMID:29156547

Degree of vertical integration between the undergraduate program and clinical internship with respect to lumbopelvic diagnostic and therapeutic procedures taught at the canadian memorial chiropractic college.

PubMed

Vermet, Shannon; McGinnis, Karen; Boodham, Melissa; Gleberzon, Brian J

2010-01-01

The objective of this study was to determine to what extent the diagnostic and therapeutic procedures taught in the undergraduate program used for patients with lumbopelvic conditions are expected to be utilized by students during their clinical internship program at Canadian Memorial Chiropractic College or are being used by the clinical faculty. A confidential survey was distributed to clinical faculty at the college. It consisted of a list of diagnostic and therapeutic procedures used for lumbopelvic conditions taught at that college. Clinicians were asked to indicate the frequency with which they performed or they required students to perform each item. Seventeen of 23 clinicians responded. The following procedures were most likely required to be performed by clinicians: posture; ranges of motion; lower limb sensory, motor, and reflex testing; and core orthopedic tests. The following were less likely to be required to be performed: Waddell testing, Schober's test, Gillet tests, and abdominal palpation. Students were expected to perform (or clinicians performed) most of the mobilization (in particular, iliocostal, iliotransverse, and iliofemoral) and spinal manipulative therapies (in particular, the procedures referred to as the lumbar roll, lumbar pull/hook, and upper sacroiliac) taught at the college. This study suggests that there was considerable, but not complete, vertical integration between the undergraduate and clinical education program at this college.

Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa.

PubMed

Jaya, Ziningi; Drain, Paul K; Mashamba-Thompson, Tivani P

2017-01-01

Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC) clinics in rural KwaZulu-Natal (KZN), South Africa. We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic's compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor). A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05. Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2%) of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics' average rating score for compliance to the WHO guidelines ranged between 64.4% (CI: 44%- 84%) and 89.2% (CI: 74%- 100%).Ten out of eleven of the clinics were rated as moderate (70-89%). All clinic have scored highest for the following audit component: equipment; process control and specimen management; and facility ad safety, with 100%. Clinics obtained the lowest scores for the assessment audit component followed by process improvement and organisation, with 40.9% (CI: 15.7-66.1%), 45.5% (CI: 10.4-80.5%) and 56.8% (CI: 31.8 81.8%), respectively. A statistically significant correlation was observed between the following: category of staff performing the HIV rapid tests in the audited clinics and service and satisfactory audit component; weekly average number of patients using the audited PHC clinics and service and satisfactory audit component; number of HIV lay counsellors in the audited clinics and quality control audit component with p<0.05. In the small audit of primary healthcare clinics located within the rural part of KwaZulu-Natal, results revealed an overall moderate rating of the quality management system for rapid HIV testing. Improvements in the organisation, quality control, process improvement and assessment components could enable a higher quality assurance rating for rural HIV testing in KwaZulu-Natal.

Liver function testing with nuclear medicine techniques is coming of age.

PubMed

Bennink, Roelof J; Tulchinsky, Mark; de Graaf, Wilmar; Kadry, Zakiyah; van Gulik, Thomas M

2012-03-01

Liver function is a broad term, as the organ participates in a multitude of different physiological and biochemical processes, including metabolic, synthetic, and detoxifying functions. However, it is the function of the hepatocyte that is central to sustaining normal life and dealing with disease states. When the liver begins to fail in severely ill patients, it forecasts a terminal outcome. However, unlike the glomerular filtration rate which clearly quantifies the key renal function, at most practice sites, there is no clinically available quantitative test for liver function. Although it is commonplace to assess indirect evidence of that function (by measuring blood levels of its end products and by-products) and to detect an acute injury (by following rising transaminases), a widely available test that would directly measure hepatocellular function is lacking. This article reviews current knowledge on liver function studies and focuses on those nuclear medicine tests available to study the whole liver and regional liver function. The clinical application driving these tests, prediction of remnant liver function after partial hepatectomy for primary liver malignancy or metastatic disease, is addressed here in detail. The test was recently validated for this specific application and was shown to be better than the current standard of practice (computed tomography volumetry), particularly in patients with hepatic comorbidities like cirrhosis, steatosis, or cholestasis. Furthermore, early assessment of regional liver function increase after preoperative portal vein embolization becomes possible with this technology. The limiting factor to a wider acceptance of this test is based on the lack of clinical software that would allow calculation of liver function parameters. This article provides information that enables a clinical nuclear medicine facility to provide this test using readily available equipment. Furthermore, it addresses emerging clinical applications that are under investigation. Copyright © 2012 Elsevier Inc. All rights reserved.

Systematic review of the clinical and economic value of gene expression profiles for invasive early breast cancer available in Europe.

PubMed

Blok, E J; Bastiaannet, E; van den Hout, W B; Liefers, G J; Smit, V T H B M; Kroep, J R; van de Velde, C J H

2018-01-01

Gene expression profiles with prognostic capacities have shown good performance in multiple clinical trials. However, with multiple assays available and numerous types of validation studies performed, the added value for daily clinical practice is still unclear. In Europe, the MammaPrint, OncotypeDX, PAM50/Prosigna and Endopredict assays are commercially available. In this systematic review, we aim to assess these assays on four important criteria: Assay development and methodology, clinical validation, clinical utility and economic value. We performed a literature search covering PubMed, Embase, Web of Science and Cochrane, for studies related to one or more of the four selected assays. We identified 147 papers for inclusion in this review. MammaPrint and OncotypeDX both have evidence available, including level IA clinical trial results for both assays. Both assays provide prognostic information. Predictive value has only been shown for OncotypeDX. In the clinical utility studies, a higher reduction in chemotherapy was achieved by OncotypeDX, although the number of available studies differ considerably between tests. On average, economic evaluations estimate that genomic testing results in a moderate increase in total costs, but that these costs are acceptable in relation to the expected improved patient outcome. PAM50/prosigna and EndoPredict showed comparable prognostic capacities, but with less economical and clinical utility studies. Furthermore, for these assays no level IA trial data are available yet. In summary, all assays have shown excellent prognostic capacities. The differences in the quantity and quality of evidence are discussed. Future studies shall focus on the selection of appropriate subgroups for testing and long-term outcome of validation trials, in order to determine the place of these assays in daily clinical practice. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

A Clinical Study of Subtype-based Prevalence of Dry Eye.

PubMed

Rege, Aditya; Kulkarni, Varsha; Puthran, Neelam; Khandgave, Tejaswini

2013-10-01

Dry Eye is a multifactorial disease of the tearfilm and the ocular surface which may be due to reduced tear production or excessive tear evaporation resulting in discomfort, visual disturbance, and tear film instability with a potential damage to the ocular surface. Various population-based studies have been done to find out the prevalence and the magnitude of the problem. Women Health Study reported prevalence of 7.8% after screening 36995 subjects above 49 years by interview. The prevalence reported by Blue Mountain Study was 15.3% .The Beaver Dam Study and Shiphai Eye studies are other studies reporting prevalence of 14.5% and 33.7% respectively. McMonnies questionnaire is a widely used screening instrument for Dry-Eye syndromes with sensitivity reportedly varying between 87% and 98% and specificity between 87% and 97%. Prevalence studies use McMonnie's questionnaire for screening individuals for Dry Eye, whereafter tests like Schirmer's test, Tear Film Break Up Time test, Rose Bengal test, Lissamine Green test and Meibomian Gland Dysfunction test are useful for further evaluation. While these tests help to differentiate the subtypes of Dry Eye such as Lipid Anomaly Dry Eye, Aqueous Tear Deficiency and Mucin Layer Deficiency, however, their sensitivity and specificity has not been widely studied. Additionally, very few studies have reported the prevalence of the various subtypes of Dry Eye. To determine the subtype-based prevalence of Dry Eye, to study the specificity and sensitivity of clinical tests for Dry Eye and to correlate McMonnies questionnaire with Dry Eye tests results. A prospective, cross-sectional, observational study, duly approved by the Institutional Ethics Committee, was conducted from October 2010 to April 2012. A total of 4750 subjects above 18 yrs of age were screened by the McMonnies questionnaire. Respondents having a score greater than 14.5 were subjected to clinical Dry Eye tests. The data obtained was analyzed using chi-square test. p value < 0.005 was considered statistically significant.The specificity and sensitivity of each clinical test was calculated using Schirmer's test as gold standard. The prevalence of Dry Eye was 15.4%, with a female preponderance (p = 0.01) and a significant increase with age above 60 years was noted (p<0.0001). Tear Film Break Up Time was the most reliable test with a good sensitivity (68.85%) and specificity (78.32%). Lipid Anomaly Dry Eye was the most prevalent (14.48%) followed by Aqueous Tear Deficiency (13.36%) and Mucin Layer Deficiency (3.51%). A positive correlation between McMonnies score and severity of Dry Eye was seen. This study suggests that Lipid Layer Anomaly is the most prevalent subtype in Dry Eye. Tear Film Break Up Time test is the most likely test to diagnose mild Dry Eye. McMonies Questionnaire can be effectively used for screening of a large population. Tear Film Break Up Time was found to have better sensitivity as well as specificity than other tests used for diagnosing Dry Eye.

The responsiveness of sensibility and strength tests in patients undergoing carpal tunnel decompression

PubMed Central

2011-01-01

Background Several clinical measures of sensory and motor function are used alongside patient-rated questionnaires to assess outcomes of carpal tunnel decompression. However there is a lack of evidence regarding which clinical tests are most responsive to clinically important change over time. Methods In a prospective cohort study 63 patients undergoing carpal tunnel decompression were assessed using standardised clinician-derived and patient reported outcomes before surgery, at 4 and 8 months follow up. Clinical sensory assessments included: touch threshold with monofilaments (WEST), shape-texture identification (STI™ test), static two-point discrimination (Mackinnon-Dellon Disk-Criminator) and the locognosia test. Motor assessments included: grip and tripod pinch strength using a digital grip analyser (MIE), manual muscle testing of abductor pollicis brevis and opponens pollicis using the Rotterdam Intrinsic Handheld Myometer (RIHM). The Boston Carpal Tunnel Questionnaire (BCTQ) was used as a patient rated outcome measure. Results Relative responsiveness at 4 months was highest for the BCTQ symptom severity scale with moderate to large effects sizes (ES = -1.43) followed by the BCTQ function scale (ES = -0.71). The WEST and STI™ were the most responsive sensory tests at 4 months showing moderate effect sizes (WEST ES = 0.55, STI ES = 0.52). Grip and pinch strength had a relatively higher responsiveness compared to thenar muscle strength but effect sizes for all motor tests were very small (ES ≤0.10) or negative indicating a decline compared to baseline in some patients. Conclusions For clinical assessment of sensibility touch threshold assessed by monofilaments (WEST) and tactile gnosis measured with the STI™ test are the most responsive tests and are recommended for future studies. The use of handheld myometry (RIHM) for manual muscle testing, despite more specifically targeting thenar muscles, was less responsive than grip or tripod pinch testing using the digital grip analyser (MIE). When assessing power and pinch strength the effect of other concomitant conditions such as degenerative joint disease on strength needs to be considered. PMID:22032626

Selective testing strategies for diagnosing group A streptococcal infection in children with pharyngitis: a systematic review and prospective multicentre external validation study

PubMed Central

Cohen, Jérémie F.; Cohen, Robert; Levy, Corinne; Thollot, Franck; Benani, Mohamed; Bidet, Philippe; Chalumeau, Martin

2015-01-01

Background: Several clinical prediction rules for diagnosing group A streptococcal infection in children with pharyngitis are available. We aimed to compare the diagnostic accuracy of rules-based selective testing strategies in a prospective cohort of children with pharyngitis. Methods: We identified clinical prediction rules through a systematic search of MEDLINE and Embase (1975–2014), which we then validated in a prospective cohort involving French children who presented with pharyngitis during a 1-year period (2010–2011). We diagnosed infection with group A streptococcus using two throat swabs: one obtained for a rapid antigen detection test (StreptAtest, Dectrapharm) and one obtained for culture (reference standard). We validated rules-based selective testing strategies as follows: low risk of group A streptococcal infection, no further testing or antibiotic therapy needed; intermediate risk of infection, rapid antigen detection for all patients and antibiotic therapy for those with a positive test result; and high risk of infection, empiric antibiotic treatment. Results: We identified 8 clinical prediction rules, 6 of which could be prospectively validated. Sensitivity and specificity of rules-based selective testing strategies ranged from 66% (95% confidence interval [CI] 61–72) to 94% (95% CI 92–97) and from 40% (95% CI 35–45) to 88% (95% CI 85–91), respectively. Use of rapid antigen detection testing following the clinical prediction rule ranged from 24% (95% CI 21–27) to 86% (95% CI 84–89). None of the rules-based selective testing strategies achieved our diagnostic accuracy target (sensitivity and specificity > 85%). Interpretation: Rules-based selective testing strategies did not show sufficient diagnostic accuracy in this study population. The relevance of clinical prediction rules for determining which children with pharyngitis should undergo a rapid antigen detection test remains questionable. PMID:25487666

Clinical Muscle Testing Compared with Whole-Body Magnetic Resonance Imaging in Facio-scapulo-humeral Muscular Dystrophy.

PubMed

Regula, J U; Jestaedt, L; Jende, F; Bartsch, A; Meinck, H-M; Weber, M-A

2016-12-01

The objective of this study was to evaluate the clinical usefulness of whole-body magnetic resonance imaging (MRI) in facio-scapulo-humeral muscular dystrophy (FSHD). In 20 patients with genetically proven FSHD1, we prospectively assessed muscular involvement and correlated the results of semi-quantitative manual muscle testing and other parameters such as disease duration, creatine kinase (CK) levels and repeat length of the D4Z4 locus with whole-body MRI. Clinical muscle testing revealed the trapezius, pectoralis and infraspinatus as the most severely affected muscles in the shoulder, and the knee flexors and gluteus medius in the hip girdle. MRI revealed the trapezius and serratus anterior muscles in the shoulder, and the hamstrings and adductor muscles in the hip girdle, as the most severely affected muscle groups. Overall, degrees of fatty degeneration on MRI scans correlated significantly with clinical weakness. Moreover, we could detect clear affection of the trunk muscles. Corresponding to earlier reports, asymmetric involvement was frequent in both clinical examination and MRI scoring. Moreover, MRI revealed inhomogeneous muscle degeneration in a considerable proportion of both, muscles and patients. Both clinical and MRI scores significantly correlated to disease duration, but not to fragment size or CK levels. Fatty degeneration in whole-body MRI correlates well to clinical muscle testing of the extremities but gives more information on deeper or trunk muscles. It shows structural changes in muscular disorders and may become an excellent tool for assessment of muscle involvement and follow-up studies.

The value of the UK Clinical Aptitude Test in predicting pre-clinical performance: a prospective cohort study at Nottingham Medical School.

PubMed

Yates, Janet; James, David

2010-07-28

The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Quantitative Reasoning, Verbal Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admissions panels in advance of the selection process. As yet the predictive validity of the test against course performance is largely unknown.The study objective was to determine whether UKCAT scores predict performance during the first two years of the 5-year undergraduate medical course at Nottingham. We studied a single cohort of students, who entered Nottingham Medical School in October 2007 and had taken the UKCAT. We used linear regression analysis to identify independent predictors of marks for different parts of the 2-year preclinical course. Data were available for 204/260 (78%) of the entry cohort. The UKCAT total score had little predictive value. Quantitative Reasoning was a significant independent predictor of course marks in Theme A ('The Cell'), (p = 0.005), and Verbal Reasoning predicted Theme C ('The Community') (p < 0.001), but otherwise the effects were slight or non-existent. This limited study from a single entry cohort at one medical school suggests that the predictive value of the UKCAT, particularly the total score, is low. Section scores may predict success in specific types of course assessment.The ultimate test of validity will not be available for some years, when current cohorts of students graduate. However, if this test of mental ability does not predict preclinical performance, it is arguably less likely to predict the outcome in the clinical years. Further research from medical schools with different types of curriculum and assessment is needed, with longitudinal studies throughout the course.

PPG, APG, duplex: which noninvasive tests are most appropriate for the management of patients with chronic venous insufficiency?

PubMed

Marston, William A

2002-03-01

Numerous noninvasive tests have been described for assistance in the diagnosis and treatment of patients with chronic venous insufficiency (CVI). These tests include venous duplex ultrasound examination in the supine and standing positions, photoplethysmography (PPG), and air plethysmography (APG). The goal of these studies is to provide accurate information describing the anatomic or the hemodynamic characteristics of the patient with CVI, precluding the need for invasive studies. These tests will be reviewed including the typical information obtained, the usefulness of this information, and the relevance for clinical management of patients with CVI. Based on the clinical class, recommendations for a noninvasive testing protocol are outlined. Copyright 2002 by W.B. Saunders Company

[Clinical Application of Non-invasive Diagnostic Tests for Liver Fibrosis].

PubMed

Shin, Jung Woo; Park, Neung Hwa

2016-07-25

The diagnostic assessment of liver fibrosis is an important step in the management of patients with chronic liver diseases. Liver biopsy is considered the gold standard to assess necroinflammation and fibrosis. However, recent technical advances have introduced numerous serum biomarkers and imaging tools using elastography as noninvasive alternatives to biopsy. Serum markers can be direct or indirect markers of the fibrosis process. The elastography-based studies include transient elastography, acoustic radiation force imaging, supersonic shear wave imaging and magnetic resonance elastography. As accumulation of clinical data shows that noninvasive tests provide prognostic information of clinical relevance, non-invasive diagnostic tools have been incorporated into clinical guidelines and practice. Here, the authors review noninvasive tests for the diagnosis of liver fibrosis.

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.

Activities of Tannins--From In Vitro Studies to Clinical Trials.

PubMed

Sieniawska, Elwira

2015-11-01

Tannins are considered as valuable plant secondary metabolites providing many benefits for human health. In this review information was gathered about bioactivity in vitro and in vivo, as well as about conducted clinical trials. The literature research was based on ScienceDirect, Scopus, and Cochrane databases and presents a wide range of tested activities of tannins. The described clinical trials verify laboratory tests and show the effective health benefits taken from supplementation with tannins.

Effects of a simulated emergency airway management education program on the self-efficacy and clinical performance of intensive care unit nurses.

PubMed

Han, Myong-Ja; Lee, Ju-Ry; Shin, Yu-Jung; Son, Jeong-Suk; Choi, Eun-Joo; Oh, Yun-Hee; Lee, Soon-Haeng; Choi, Hye-Ran

2017-12-21

To examine the effects of a simulated emergency airway management education program on the self-efficacy and clinical performance among nurses in intensive care units. A one-group, pre- and post-test design was used. Thirty-five nurses who were working in adult intensive care units participated in this study. The simulation education program included lectures, skill demonstration, skill training, team-based practice, and debriefing. Self-efficacy and clinical performance questionnaires were completed before the program and 1 week after its completion. The data were analyzed by using descriptive statistics and the paired t-test to compare the mean differences between the pre-test and post-test. The scores before and after education were compared. After education, there was a significant improvement in the nurses' self-efficacy and clinical performance in emergency airway management situations. Simulation education effectively improved the self-efficacy and clinical performance of the nurses who were working in intensive care units. Based on the program for clinical nurses within a hospital, it will provide information that might advance clinical nursing education. © 2017 Japan Academy of Nursing Science.

Institutional mistrust in the organization of pharmaceutical clinical trials

PubMed Central

2010-01-01

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects' compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. PMID:18633728

Defining thresholds of specific IgE levels to grass pollen and birch pollen allergens improves clinical interpretation.

PubMed

Van Hoeyveld, Erna; Nickmans, Silvie; Ceuppens, Jan L; Bossuyt, Xavier

2015-10-23

Cut-off values and predictive values are used for the clinical interpretation of specific IgE antibody results. However, cut-off levels are not well defined, and predictive values are dependent on the prevalence of disease. The objective of this study was to document clinically relevant diagnostic accuracy of specific IgE for inhalant allergens (grass pollen and birch pollen) based on test result interval-specific likelihood ratios. Likelihood ratios are independent of the prevalence and allow to provide diagnostic accuracy information for test result intervals. In a prospective study we included consecutive adult patients presenting at an allergy clinic with complaints of rhinitis or rhinoconjunctivitis. The standard for diagnosis was a suggestive clinical history of grass or birch pollen allergy and a positive skin test. Specific IgE was determined with the ImmunoCAP Fluorescence Enzyme Immuno-Assay. We established specific IgE test result interval related likelihood ratios for clinical allergy to inhalant allergens (grass pollen, rPhl p 1,5, birch pollen, rBet v 1). The likelihood ratios for allergy increased with increasing specific IgE antibody levels. The likelihood ratio was <0.03 for specific IgE <0.1 kU/L, between 0.1 and 1.4 for specific IgE between 0.1 kU/L and 0.35 kU/L, between 1.4 and 4.2 for specific IgE between 0.35 kU/L and 3.5 kU/L, >6.3 for specific IgE>0.7, and very high (∞) for specific IgE >3.5 kU/L. Test result interval specific likelihood ratios provide a useful tool for the interpretation of specific IgE test results for inhalant allergens. Copyright © 2015 Elsevier B.V. All rights reserved.

What variables can influence clinical reasoning?

PubMed

Ashoorion, Vahid; Liaghatdar, Mohammad Javad; Adibi, Peyman

2012-12-01

Clinical reasoning is one of the most important competencies that a physician should achieve. Many medical schools and licensing bodies try to predict it based on some general measures such as critical thinking, personality, and emotional intelligence. This study aimed at providing a model to design the relationship between the constructs. Sixty-nine medical students participated in this study. A battery test devised that consist four parts: Clinical reasoning measures, personality NEO inventory, Bar-On EQ inventory, and California critical thinking questionnaire. All participants completed the tests. Correlation and multiple regression analysis consumed for data analysis. There is low to moderate correlations between clinical reasoning and other variables. Emotional intelligence is the only variable that contributes clinical reasoning construct (r=0.17-0.34) (R(2) chnage = 0.46, P Value = 0.000). Although, clinical reasoning can be considered as a kind of thinking, no significant correlation detected between it and other constructs. Emotional intelligence (and its subscales) is the only variable that can be used for clinical reasoning prediction.

Merits and pitfalls of genetic testing in a hypertrophic cardiomyopathy clinic.

PubMed

Arad, Michael; Monserrat, Lorenzo; Haron-Khun, Shiraz; Seidman, Jonathan G; Seidman, Christine E; Arbustini, Eloisa; Glikson, Michael; Freimark, Dov

2014-11-01

Hypertrophic cardiomyopathy (HCM) is a familial disease with autosomal dominant inheritance and age-dependent penetrance, caused primarily by mutations of sarcomere genes. Because the clinical variability of HCM is related to its genetic heterogeneity, genetic studies may improve the diagnosis and prognostic evaluation in HCM. To analyze the impact of genetic diagnosis on the clinical management of HCM. Genetic studies were performed for either research or clinical reasons. Once the disease-causing mutation was identified, the management plan was reevaluated. Family members were invited to receive genetic counseling and encouraged to be tested for the mutation. Ten mutations in sarcomere protein genes were identified in 9 probands: 2 novel and 8 previously described. Advanced heart failure or sudden death in a young person prompted the genetic study in 8 of the 9 families. Of 98 relatives available for genotyping, only 53 (54%) agreed to be tested. The compliance was higher in families with sudden death and lower in what appeared to be sporadic HCM or elderly-onset disease. Among the healthy we identified 9 carriers and 19 non-carriers. In 6 individuals the test result resolved an uncertainty about "possible HCM." In several cases the genetic result was also used for family planning and played a role in decisions on cardioverter-defibrillator implantation. Recurrence of a same mutation in different families created an opportunity to apply the information from the literature for risk stratification of individual patients. We suggest that the clinical context determines the indication for genetic testing and interpretation of the results.

Synthesizing Information from Language Samples and Standardized Tests in School-Age Bilingual Assessment

ERIC Educational Resources Information Center

Ebert, Kerry Danahy; Pham, Giang

2017-01-01

Purpose: Although language samples and standardized tests are regularly used in assessment, few studies provide clinical guidance on how to synthesize information from these testing tools. This study extends previous work on the relations between tests and language samples to a new population--school-age bilingual speakers with primary language…

Antibiotic resistance and virulence traits in clinical and environmental Enterococcus faecalis and Enterococcus faecium isolates.

PubMed

Rathnayake, I U; Hargreaves, M; Huygens, F

2012-07-01

This study compared virulence and antibiotic resistance traits in clinical and environmental Enterococcus faecalis and Enterococcus faecium isolates. E. faecalis isolates harboured a broader spectrum of virulence determinants compared to E. faecium isolates. The virulence traits Cyl-A, Cyl-B, Cyl-M, gel-E, esp and acm were tested and environmental isolates predominantly harboured gel-E (80% of E. faecalis and 31.9% of E. faecium) whereas esp was more prevalent in clinical isolates (67.8% of E. faecalis and 70.4% of E. faecium). E. faecalis and E. faecium isolated from water had different antibiotic resistance patterns compared to those isolated from clinical samples. Linezolid resistance was not observed in any isolates tested and vancomycin resistance was observed only in clinical isolates. Resistance to other antibiotics (tetracycline, gentamicin, ciprofloxacin and ampicillin) was detected in both clinical and water isolates. Clinical isolates were more resistant to all the antibiotics tested compared to water isolates. Multi-drug resistance was more prevalent in clinical isolates (71.2% of E. faecalis and 70.3% of E. faecium) compared to water isolates (only 5.7% E. faecium). tet L and tet M genes were predominantly identified in tetracycline-resistant isolates. All water and clinical isolates resistant to ciprofloxacin and ampicillin contained mutations in the gyrA, parC and pbp5 genes. A significant correlation was found between the presence of virulence determinants and antibiotic resistance in all the isolates tested in this study (p<0.05). The presence of antibiotic resistant enterococci, together with associated virulence traits, in surface recreational water could be a public health risk. Copyright © 2012 Elsevier GmbH. All rights reserved.

The quality of veterinary in-clinic and reference laboratory biochemical testing.

PubMed

Rishniw, Mark; Pion, Paul D; Maher, Tammy

2012-03-01

Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

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.

Association with isokinetic ankle strength measurements and normal clinical muscle testing in sciatica patients.

PubMed

Ustun, N; Erol, O; Ozcakar, L; Ceceli, E; Ciner, O Akar; Yorgancioglu, Z R

2013-01-01

Sensitive muscle strength tests are needed to measure muscle strength in the diagnosis and management of sciatica patients. The aim of this study was to assess the isokinetic muscle strength in sciatica patients' and control subjects' ankles that exhibited normal ankle muscle strength when measured clinically. Forty-six patients with L5 and/or S1 nerve compression, and whose age, sex, weight, and height matched 36 healthy volunteers, were recruited to the study. Heel-walking, toe-walking, and manual muscle testing were used to perform ankle dorsiflexion and plantar flexion strengths in clinical examination. Patients with normal ankle dorsiflexion and plantar flexion strengths assessed by manual muscle testing and heel-and toe-walking tests were included in the study. Bilateral isokinetic (concentric/concentric) ankle plantar-flexion-dorsiflexion measurements of the patients and controls were performed within the protocol of 30°/sec (5 repetitions). Peak torque and peak torque/body weight were obtained for each ankle motion of the involved limb at 30°/s speed. L5 and/or S1 nerve compression was evident in 46 patients (76 injured limbs). Mean disease duration was two years. The plantar flexion muscle strength of the patients was found to be lower than that of the controls (p=0.036). The dorsiflexion muscle strength of the patients was found to be the same as that of the controls (p=0.211). Isokinetic testing is superior to clinical muscle testing when evaluating ankle plantar flexion torque in sciatica patients. Therefore, isokinetic muscle testing may be helpful when deciding whether to place a patient into a focused rehabilitation program.

Studies and applications of NiTi shape memory alloys in the medical field in China.

PubMed

Dai, K; Chu, Y

1996-01-01

The biomedical study of NiTi shape memory alloys has been undertaken in China since 1978. A series of stimulating corrosion tests, histological observations, toxicity tests, carcinogenicity tests, trace nickel elements analysis and a number of clinical trials have been conducted. The results showed that the NiTi shape memory alloy is a good biomaterial with good biocompatibility and no obvious local tissue reaction, carcinogenesis or erosion of implants were found experimentally or clinically. In 1981, on the basis of fundamental studies, a shape memory staple was used for the first time inside the human body. Subsequently, various shape memory devices were designed and applied clinically for internal fixation of fractures, spine surgery, endoprostheses, gynaecological and craniofacial surgery. Since 1990, a series of internal stents have been developed for the management of biliary, tracheal and esophageal strictures and urethrostenosis as well as vascular obturator for tumour management. Several thousand cases have been treated and had a 1-10 year follow-up and good clinical results with a rather low complication rate were obtained.

Assessment of maternal antibody decay and response to canine parvovirus vaccination using a clinic-based enzyme-linked immunosorbent assay.

PubMed

Waner, T; Naveh, A; Wudovsky, I; Carmichael, L E

1996-10-01

Interference caused by maternal antibodies is considered a major cause of canine parvovirus (CPV) vaccination failure. In this study, an immunoblot clinic-based enzyme-linked immunosorbent assay (ELISA) method was used to detect CPV antibodies in sera of pregnant bitches and their offspring to study the response of pups to vaccination. With a easily accessible procedure for CPV antibody determination, the veterinarian should be able to gauge the response of pups after vaccination. The validity of the technique was tested in parallel against the standard hemagglutination inhibition (HI) test. Results of the ELISA were correlated with those of the standard HI method for quantification of CPV antibodies. With the ELISA, successfully immunized pups were identified, allowing for a more reliable and cost-effective program of vaccination. This simple clinic-based test could be used for the assessment of vaccination status of pups during the critical phase of 6 to about 16 weeks of age. This study is the first in which vaccination response to CPV in pups was followed, using a clinic-based ELISA for CPV antibody monitoring.

Use of a medication control officer to reduce bias in a clinical trial: lessons learned from the scleroderma lung study.

PubMed

Hsu, Vivien M; Khanna, Dinesh; Smith, Edwin; Filemon, Tan; Whelton, Sean; Lopata, Mel; Davis, John C; Polito, Albert; Heck, Louis; Molitor, Jerry; Abeles, Micha; Granda, Jose; Korn, Joseph; Clements, Philip

2010-02-01

Scleroderma Lung Study (SLS) was designed to evaluate the efficacy and safety of oral cyclophosphamide (CYC) versus placebo taken for 1 year for scleroderma-associated interstitial lung disease. An independent medication control officer (MCO), usually a physician, at each center was assigned to monitor laboratory and clinical toxicity of study medication and regulate its dosing based on these results. By having an MCO who watched and managed toxicity, the study investigators were free to care for study patients and to assess study outcomes without the potential bias of knowing toxicity data (toxicity from cyclophosphamide is distinctive - cytopenias and hematuria in particular). To assess the usefulness of an MCO, whose chief role was to maintain safety while retaining the blinding in the clinical trial. Patients had safety laboratory testing every 2-4 weeks and results were sent directly to the MCO within 2 days of the test. Other clinical adverse events (AEs) were reported by the patient to a nurse coordinator who reported them to the MCO who then managed the AEs to preserve the blinding of investigators caring for the patients. The MCO was provided pre-determined algorithms for dose adjustments of test medication based on the presence and severity of laboratory abnormalities. Safety monitoring by the MCO was effective in the early detection of drug toxicity with provision of appropriate medical intervention on a timely basis. At the same time, investigator blinding appeared to be maintained. The testing of MCO effectiveness in maintaining blinding and consistency was not defined as an a priori hypothesis and thus complete data relating to the efficacy of the MCO were not collected in a prospective fashion. An MCO and pre-specified monitoring and dosing guidelines, coupled with uniform pre-specified responses to AEs, may be used effectively to preserve investigator blinding and provide consistency in response to AEs in a clinical trial setting, even when AEs of the test medication are distinctive.

Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

PubMed

Bradbury, Angela R; Patrick-Miller, Linda; Long, Jessica; Powers, Jacquelyn; Stopfer, Jill; Forman, Andrea; Rybak, Christina; Mattie, Kristin; Brandt, Amanda; Chambers, Rachelle; Chung, Wendy K; Churpek, Jane; Daly, Mary B; Digiovanni, Laura; Farengo-Clark, Dana; Fetzer, Dominique; Ganschow, Pamela; Grana, Generosa; Gulden, Cassandra; Hall, Michael; Kohler, Lynne; Maxwell, Kara; Merrill, Shana; Montgomery, Susan; Mueller, Rebecca; Nielsen, Sarah; Olopade, Olufunmilayo; Rainey, Kimberly; Seelaus, Christina; Nathanson, Katherine L; Domchek, Susan M

2015-06-01

Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies. Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group developed a tiered-binned genetic counseling approach proposed to facilitate informed consent and improve outcomes of cancer susceptibility multiplex testing. In this model, tier 1 "indispensable" information is presented to all patients. More specific tier 2 information is provided to support variable informational needs among diverse patient populations. Clinically relevant information is "binned" into groups to minimize information overload, support informed decision making, and facilitate adaptive responses to testing. Seven essential elements of informed consent are provided to address the unique limitations, risks, and uncertainties of multiplex testing. A tiered-binned model for informed consent and genetic counseling has the potential to address the challenges of multiplex testing for cancer susceptibility and to support informed decision making and adaptive responses to testing. Future prospective studies including patient-reported outcomes are needed to inform how to best incorporate multiplex testing for cancer susceptibility into clinical practice.Genet Med 17 6, 485-492.

Clinical Usefulness of the Pendulum Test Using a NK Table to Measure the Spasticity of Patients with Brain Lesions

PubMed Central

Kim, Yong-Wook

2013-01-01

. [Purpose] The purpose of the present study was to investigate the clinical usefulness (reliability and validity) of the pendulum test using a Noland-Kuckhoff (NK) table with an attached electrogoniometer to measure the spasticity of patients with brain lesions. [Subjects] The subjects were 31 patients with stroke or traumatic brain injury. [Methods] The intraclass correlation coefficient (ICC) was used to verify the test–retest reliability of spasticity measures obtained using the pendulum test. Pearson's product correlation coefficient was used to examine the validity of the pendulum test using the amplitude of the patellar tendon reflex (PTR) test, an objective and quantitative measure of spasticity. [Results] The test–retest reliability was high, reflecting a significant correlation between the test and the retest (ICCs = 0.95–0.97). A significant negative correlation was found between the amplitude of the PTR test and the four variables measured in the pendulum test (r = −0.77– −0.85). [Conclusion] The pendulum test using a NK table is an objective measure of spasticity and can be used in the clinical setting in place of more expensive and complicated equipment. Further studies are needed to investigate the therapeutic effect of this method on spasticity. PMID:24259775

Treatment of Chronic Breath-Holding in an Adult with Severe Mental Retardation: A Clinical Case Study

ERIC Educational Resources Information Center

Reed, Derek D.; Martens, Brian K.

2008-01-01

We describe a clinical case study surrounding the behavioral assessment and operant treatment of, an adult with severe mental retardation who engaged in chronic breath-holding. In this clinical case, previous neurological and medical testing had ruled out biological bases for the individual's breath-holding. A functional behavioral assessment…

Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

PubMed

Frank, Bryan L

2017-10-01

Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

Does patient-perceived handicap correspond to the modified clinical test for the sensory interaction on balance?

PubMed

Loughran, Sean; Gatehouse, Stuart; Kishore, Ameet; Swan, Iain R C

2006-01-01

To determine whether patient self-reported handicap correlates with scores obtained from the modified Clinical Test for the Sensory Interaction on Balance as assessed by the Neurocom VSR Balance Master platform. Prospective observational. Balance clinic in tertiary referral center. Patients referred with dizziness or imbalance as their primary complaint. The modified Clinical Test for the Sensory Interaction on Balance scores as assessed by the Neurocom VSR Balance Master platform, the Dizziness Handicap Inventory, and the Health Utilities Index Marks 2 and 3. One hundred fifty-nine patients were entered into the study. The mean age of participants was 54.5 years, with a female-to-male ratio of 2.1:1. The scores for the Dizziness Handicap Inventory and Health Utilities Index are similar between sexes, and although the Dizziness Handicap Inventory score did not correlate with age, Health Utilities Index 2 and 3 scores did show a negative correlation with increasing age. There are weak, positive correlations between the Dizziness Handicap Inventory and the firm surface conditions of the modified Clinical Test for the Sensory Interaction on Balance but no useful correlation with the foam conditions. Similar weak negative correlations were found between the Health Utilities Index 2 and 3 and the modified Clinical Test for the Sensory Interaction on Balance scores. Patient-perceived handicap of imbalance appears to correlate poorly with assessment of postural stability using the modified Clinical Test for the Sensory Interaction on Balance.

The Clinical Practice of Assessing Cognitive Function in Adults Receiving Electroconvulsive Therapy: Whom Are We Missing?

PubMed

Obbels, Jasmien; Vanbrabant, Koen; Bouckaert, Filip; Verwijk, Esmée; Sienaert, Pascal

2016-06-01

Cognition can be affected by electroconvulsive therapy (ECT). Good clinical practice includes neuropsychological assessment, although this is seldom a part of routine clinical practice. It looks like a substantial part of patients fail to complete cognitive assessments. This constitutes a problem in the generalizability of published clinical research on cognitive side effects. Most studies of ECT-related cognitive adverse effects do not discuss this important issue of so-called cognitive test nonparticipants. Recent findings suggest that cognitive test nonparticipants are more severely ill, and probably more vulnerable to cognitive side effects. To examine the feasibility of a neuropsychological test battery in daily clinical practice, in an adult population referred for ECT. We reviewed the clinical records of 84 patients referred for ECT. Demographic and clinical characteristics of those patients who were able to complete our routine cognitive testing at baseline are compared with those who could not complete the assessment. From 84 ECT patients, 60 (71%) completed a pre-ECT cognitive assessment, whereas 24 (29%) did not. Patients with a unipolar depression, with psychotic symptoms, who started their treatment with a bitemporal electrode placement were more likely to be test noncompleters than test completers. Patients with a unipolar depression, with psychotic features, who are treated with a bitemporal electrode placement, have a higher likelihood of not completing a pre-ECT cognitive assessment. These patients probably represent a subgroup more vulnerable to cognitive side effects.

Clinical Application of Pharmacogenetics: Where are We Now?

PubMed Central

2014-01-01

Pharmacogenetic (PGx) testing has the potential to improve drug therapy in an individual by informing appropriate drug dosing or drug selection in order to maximize efficacy and safety. Although multiple studies have illustrated the potential benefits of such testing when applied to specific drugs across a broad range of therapy areas, the uptake of PGx testing in routine clinical practice has been relatively limited. Implementation appears to be hampered by the absence of sufficiently strong evidence linking the results of testing with actionable benefits in terms of clinical outcomes. Meanwhile, there are now adequate data to allow dosing recommendations as have been developed by bodies including the Dutch Pharmacogenetics Working Group (DPWG) and the Clinical Pharmacogenetics Implementation Consortium (CPIC) in several settings, including TPMT/thiopurines, CYP2C19/clopidogrel, CYP2D6/codeine, VKORC1-CYP2C9/warfarin, HLA-B*5701/abacavir, SLCO1B1/simvastatin and HLAB*5801/allopurinol. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) have also recently initiated surveys in order to better understand the extent of, and the role played by, PGx testing in clinical practice. This should help identify where further training and education may be beneficial. To this end, in collaboration with ESPT, the IFCC Pharmacogenetic Laboratory Network has now been formed, with the aim of improving the uptake and quality of PGx testing. PMID:27683445

Atopy patch tests in young adult patients with atopic dermatitis and controls: dose-response relationship, objective reading, reproducibility and clinical interpretation.

PubMed

Bygum, Anette; Mortz, Charlotte Gotthard; Andersen, Klaus Ejner

2003-01-01

The clinical interpretation and reproducibility of atopy patch tests was studied in 23 selected young adult patients with atopic dermatitis and 25 healthy controls using standard inhalant allergens. Non-invasive measurements were used for objective assessment of test reactions and the participants were retested after 6 weeks. Ten of 19 (53%) evaluable patients with atopic dermatitis had at least one positive atopy patch test. However, there was no clear clinical relevance of the atopy patch test results when related to patient history and distribution of dermatitis. Reproducible and dose-dependent results were obtained with Dermatophagoides pteronyssinus, grass and cat with a reproducibility rate of 0.69 to 0.81 in patients and 0.60-0.96 in controls. A unique finding was a significant positive correlation between a positive atopy patch test, allergen dose and increase in transepidermal water loss and erythema, while measurement of capacitance did not distinguish between positive and negative reactions. The results of the present study do not support the routine use of atopy patch tests in the evaluation of adult patients with atopic dermatitis.

A comparative, randomized, controlled study on clinical efficacy and dental staining reduction of a mouthwash containing Chlorhexidine 0.20% and Anti Discoloration System (ADS).

PubMed

Marrelli, Massimo; Amantea, Massimiliano; Tatullo, Marco

2015-01-01

A good control of bacterial plaque is an essential factor for the success of periodontal therapy, therefore it is the main objective that the clinician together with the patient must get to have a healthy periodontium. The plaque control with mouthwashes is the most important home therapy as it helps to reduce the formation of plaque between the mechanical removal with a toothbrush. Authors analyzed the clinical data from a trial carried out with 3 different mouthwashes containing 0.2% Chlorhexidine (CHX). In addition, the ADS (Anti Discoloration System - Curaden Healthcare) was tested in comparison with the other mouthwashes without this system. We tested antiplaque activity showed by 3 of the most commercialized mouthwashes, moreover, we tested the ability in reducing the dental staining related to the oral assumption of Chlorhexidine. Our results demonstrated the clinical efficacy of the 3 mouthwashes with CHX. Particularly performing was the anti discoloration system (Curaden Healthcare), with a clinical detection of dental stainings significantly less than the others tested. This study demonstrated the clinical efficacy of ADS system in the reduction of tooth staining, without a loss of antiplaque activity with respect to the competing mouthwashes containing CHX.

Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa

PubMed Central

Jaya, Ziningi; Drain, Paul K.

2017-01-01

Introduction Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC) clinics in rural KwaZulu-Natal (KZN), South Africa. Material and methods We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic’s compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor). A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05. Results Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2%) of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics’ average rating score for compliance to the WHO guidelines ranged between 64.4% (CI: 44%– 84%) and 89.2% (CI: 74%– 100%).Ten out of eleven of the clinics were rated as moderate (70–89%). All clinic have scored highest for the following audit component: equipment; process control and specimen management; and facility ad safety, with 100%. Clinics obtained the lowest scores for the assessment audit component followed by process improvement and organisation, with 40.9% (CI: 15.7–66.1%), 45.5% (CI: 10.4–80.5%) and 56.8% (CI: 31.8 81.8%), respectively. A statistically significant correlation was observed between the following: category of staff performing the HIV rapid tests in the audited clinics and service and satisfactory audit component; weekly average number of patients using the audited PHC clinics and service and satisfactory audit component; number of HIV lay counsellors in the audited clinics and quality control audit component with p<0.05. Discussion In the small audit of primary healthcare clinics located within the rural part of KwaZulu-Natal, results revealed an overall moderate rating of the quality management system for rapid HIV testing. Improvements in the organisation, quality control, process improvement and assessment components could enable a higher quality assurance rating for rural HIV testing in KwaZulu-Natal. PMID:28829801

Clinical implementation of KRAS testing in metastatic colorectal carcinoma: the pathologist's perspective.

PubMed

Ross, Jeffrey S

2012-10-01

Mutation status of the KRAS gene identifies a distinct disease subtype of metastatic colorectal carcinoma that does not respond to antibody therapeutics targeting the epidermal growth factor receptor. This is currently the only validated marker in metastatic colorectal carcinoma with a clear implication in treatment selection. KRAS testing is widely accepted in clinical practice to guide metastatic colorectal carcinoma therapeutic decisions, and there are many commercially available platforms to perform the test. To evaluate the critical role of pathologists in the full implementation of KRAS testing by optimizing tumor tissue collection and fixation procedures and by choosing testing technologies and reliable Clinical Laboratory Improvement Amendments of 1988-certified laboratories to perform the tests. Prospective clinical trials, retrospective studies, and quality assessment and survey reports were identified in the following databases: PubMed, American Society of Clinical Oncology Proceedings (American Society of Clinical Oncology Annual Meeting and Gastrointestinal Cancer Symposium) and European Society for Medical Oncology Proceedings (Annals of Oncology European Society for Medical Oncology Congress and Annals of Oncology World Congress on Gastrointestinal Cancers). More bona fide standards are needed to address the variety of available test methods, which have different performance characteristics including speed, sensitivity to detect rare mutations, and technical requirements. Refined standards addressing timing of KRAS testing, laboratory performance and accuracy, quality assurance and control, proper tissue collection, and appropriate result reporting would also be greatly beneficial. Pathologists should be aware that the amount of information they need to manage will increase, because future trends and technological advances will enhance the predictive power of diagnostic tests or the scope of the biomarker panels tested routinely across tumor types.

Real-Time Electronic Tracking of Diarrheal Episodes and Laxative Therapy Enables Verification of Clostridium difficile Clinical Testing Criteria and Reduction of Clostridium difficile Infection Rates.

PubMed

Truong, Cynthia Y; Gombar, Saurabh; Wilson, Richard; Sundararajan, Gopalakrishnan; Tekic, Natasa; Holubar, Marisa; Shepard, John; Madison, Alexandra; Tompkins, Lucy; Shah, Neil; Deresinski, Stan; Schroeder, Lee F; Banaei, Niaz

2017-05-01

Health care-onset health care facility-associated Clostridium difficile infection (HO-CDI) is overdiagnosed for several reasons, including the high prevalence of C. difficile colonization and the inability of hospitals to limit testing to patients with clinically significant diarrhea. We conducted a quasiexperimental study from 22 June 2015 to 30 June 2016 on consecutive inpatients with C. difficile test orders at an academic hospital. Real-time electronic patient data tracking was used by the laboratory to enforce testing criteria (defined as the presence of diarrhea [≥3 unformed stools in 24 h] and absence of laxative intake in the prior 48 h). Outcome measures included C. difficile test utilization, HO-CDI incidence, oral vancomycin utilization, and clinical complications. During the intervention, 7.1% (164) and 9.1% (211) of 2,321 C. difficile test orders were canceled due to absence of diarrhea and receipt of laxative therapy, respectively. C. difficile test utilization decreased upon implementation from an average of 208.8 tests to 143.0 tests per 10,000 patient-days ( P < 0.001). HO-CDI incidence rate decreased from an average of 13.0 cases to 9.7 cases per 10,000 patient-days ( P = 0.008). Oral vancomycin days of therapy decreased from an average of 13.8 days to 9.4 days per 1,000 patient-days ( P = 0.009). Clinical complication rates were not significantly different in patients with 375 canceled orders compared with 869 episodes with diarrhea but negative C. difficile results. Real-time electronic clinical data tracking is an effective tool for verification of C. difficile clinical testing criteria and safe reduction of inflated HO-CDI rates. Copyright © 2017 American Society for Microbiology.

Poor Positive Predictive Value of Lyme Disease Serologic Testing in an Area of Low Disease Incidence.

PubMed

Lantos, Paul M; Branda, John A; Boggan, Joel C; Chudgar, Saumil M; Wilson, Elizabeth A; Ruffin, Felicia; Fowler, Vance; Auwaerter, Paul G; Nigrovic, Lise E

2015-11-01

Lyme disease is diagnosed by 2-tiered serologic testing in patients with a compatible clinical illness, but the significance of positive test results in low-prevalence regions has not been investigated. We reviewed the medical records of patients who tested positive for Lyme disease with standardized 2-tiered serologic testing between 2005 and 2010 at a single hospital system in a region with little endemic Lyme disease. Based on clinical findings, we calculated the positive predictive value of Lyme disease serology. Next, we reviewed the outcome of serologic testing in patients with select clinical syndromes compatible with disseminated Lyme disease (arthritis, cranial neuropathy, or meningitis). During the 6-year study period 4723 patients were tested for Lyme disease, but only 76 (1.6%) had positive results by established laboratory criteria. Among 70 seropositive patients whose medical records were available for review, 12 (17%; 95% confidence interval, 9%-28%) were found to have Lyme disease (6 with documented travel to endemic regions). During the same time period, 297 patients with a clinical illness compatible with disseminated Lyme disease underwent 2-tiered serologic testing. Six of them (2%; 95% confidence interval, 0.7%-4.3%) were seropositive, 3 with documented travel and 1 who had an alternative diagnosis that explained the clinical findings. In this low-prevalence cohort, fewer than 20% of positive Lyme disease tests are obtained from patients with clinically likely Lyme disease. Positive Lyme disease test results may have little diagnostic value in this setting. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

A note on sample size calculation for mean comparisons based on noncentral t-statistics.

PubMed

Chow, Shein-Chung; Shao, Jun; Wang, Hansheng

2002-11-01

One-sample and two-sample t-tests are commonly used in analyzing data from clinical trials in comparing mean responses from two drug products. During the planning stage of a clinical study, a crucial step is the sample size calculation, i.e., the determination of the number of subjects (patients) needed to achieve a desired power (e.g., 80%) for detecting a clinically meaningful difference in the mean drug responses. Based on noncentral t-distributions, we derive some sample size calculation formulas for testing equality, testing therapeutic noninferiority/superiority, and testing therapeutic equivalence, under the popular one-sample design, two-sample parallel design, and two-sample crossover design. Useful tables are constructed and some examples are given for illustration.

Longitudinal Brain Magnetic Resonance Imaging CO2 Stress Testing in Individual Adolescent Sports-Related Concussion Patients: A Pilot Study.

PubMed

Mutch, W Alan C; Ellis, Michael J; Ryner, Lawrence N; Morissette, Marc P; Pries, Philip J; Dufault, Brenden; Essig, Marco; Mikulis, David J; Duffin, James; Fisher, Joseph A

2016-01-01

Advanced neuroimaging studies in concussion have been limited to detecting group differences between concussion patients and healthy controls. In this small pilot study, we used brain magnetic resonance imaging (MRI) CO2 stress testing to longitudinally assess cerebrovascular responsiveness (CVR) in individual sports-related concussion (SRC) patients. Six SRC patients (three males and three females; mean age = 15.7, range = 15-17 years) underwent longitudinal brain MRI CO2 stress testing using blood oxygen level-dependent (BOLD) MRI and model-based prospective end-tidal CO2 targeting under isoxic conditions. First-level and second-level comparisons were undertaken using statistical parametric mapping (SPM) to score the scans and compare them to an atlas of 24 healthy control subjects. All tests were well tolerated and without any serious adverse events. Anatomical MRI was normal in all study participants. The CO2 stimulus was consistent between the SRC patients and control subjects and within SRC patients across the longitudinal study. Individual SRC patients demonstrated both quantitative and qualitative patient-specific alterations in CVR (p < 0.005) that correlated strongly with clinical findings, and that persisted beyond clinical recovery. Standardized brain MRI CO2 stress testing is capable of providing a longitudinal assessment of CVR in individual SRC patients. Consequently, larger prospective studies are needed to examine the utility of brain MRI CO2 stress testing as a clinical tool to help guide the evaluation, classification, and longitudinal management of SRC patients.

Does Cognitive Behavioral Therapy for Youth Anxiety Outperform Usual Care in Community Clinics? An Initial Effectiveness Test

ERIC Educational Resources Information Center

Southam-Gerow, Michael A.; Weisz, John R.; Chu, Brian C.; McLeod, Bryce D.; Gordis, Elana B.; Connor-Smith, Jennifer K.

2010-01-01

Objective: Most tests of cognitive behavioral therapy (CBT) for youth anxiety disorders have shown beneficial effects, but these have been efficacy trials with recruited youths treated by researcher-employed therapists. One previous (nonrandomized) trial in community clinics found that CBT did not outperform usual care (UC). The present study used…

Interictal and Postictal Performances on Dichotic Listening Test in Children with Focal Epilepsy

ERIC Educational Resources Information Center

Carlsson, G.; Wiegand, G.; Stephani, U.

2011-01-01

Dichotic listening test (DL) is an important tool to disclose speech dominance in healthy subjects and in clinical cases. The aim of this study was to probe if focal epilepsy in children reveals a corresponding suppression of the ear reports contralateral to seizure onset site. Thus, 15 children and adolescents with clinically and…

Cataract Research Testing

NASA Image and Video Library

2016-04-18

Dr. Rafat Ansari and James King testing their dynamic light scattering clinical device in NASA's Vision Research Laboratory at NASA Glenn. The objective is to diagnose eye diseases non-invasively long before the clinical symptoms appear and help find non-surgical medical treatments. The device shown was recently used in humans by ophthalmologists and scientists for the study of early onset of cataracts.

Learned Helplessness and Depression in a Clinical Population: A Test of Two Behavioral Hypotheses

ERIC Educational Resources Information Center

And Others; Price, Kenneth P.

1978-01-01

This study was undertaken to extend the learned helplessness phenomenon to a clinical population and to test the competing hypotheses of Seligman and Lewinsohn. 96 male hospitalized psychiatric and medical patients were randomly assigned to one of four experimental conditions. Results replicate the learned helplessness phenomenon in a group of…

"People like numbers": a descriptive study of cognitive assessment methods in clinical practice for Aboriginal Australians in the Northern Territory.

PubMed

Dingwall, Kylie M; Pinkerton, Jennifer; Lindeman, Melissa A

2013-01-31

Achieving culturally fair assessments of cognitive functioning for Aboriginal people is difficult due to a scarcity of appropriately validated tools for use with this group. As a result, some Aboriginal people with cognitive impairments may lack fair and equitable access to services. The objective of this study was to examine current clinical practice in the Northern Territory regarding cognitive assessment for Aboriginal people thereby providing some guidance for clinicians new to this practice setting. Qualitative enquiry was used to describe practice context, reasons for assessment, and current practices in assessing cognition for Aboriginal Australians. Semi-structured interviews were conducted with 22 clinicians working with Aboriginal clients in central and northern Australia. Results pertaining to assessment methods are reported. A range of standardised tests were utilised with little consistency across clinical practice. Nevertheless, it was recognised that such tests bear severe limitations, requiring some modification and significant caution in their interpretation. Clinicians relied heavily on informal assessment or observations, contextual information and clinical judgement. Cognitive tests developed specifically for Aboriginal people are urgently needed. In the absence of appropriate, validated tests, clinicians have relied on and modified a range of standardised and informal assessments, whilst recognising the severe limitations of these. Past clinical training has not prepared clinicians adequately for assessing Aboriginal clients, and experience and clinical judgment were considered crucial for fair interpretation of test scores. Interpretation guidelines may assist inexperienced clinicians to consider whether they are achieving fair assessments of cognition for Aboriginal clients.

Use of the 1 tuberculin unit (TU) Mantoux test in the assessment of tuberculous infection in children following neonatal BCG vaccination.

PubMed

Hoskyns, E W; Simpson, H; Monk, P

1994-10-01

BCG vaccination alters the response to tuberculin testing and influences the potential validity of the Heaf test in the diagnosis of tuberculosis. This study used a purified protein derivative 1 tuberculin unit (TU) Mantoux test with a cut off of 5 mm induration as an indicator of tuberculous infection in high risk children to determine whether this would distinguish infection from previous neonatal BCG vaccination. Children at high risk of tuberculosis on chest radiography, Heaf test, or contact history who had been screened in the contact tracing clinic and referred for further assessment were included in the study. After clinical examination, chest radiography, and Mantoux testing they were assigned to three groups (tuberculous disease, chemoprophylaxis, or no treatment) and followed up for 6-24 months in the outpatient clinic and subsequently by postal questionnaire. Comparison of the Heaf and Mantoux tests showed a difference in the results with 82% of cases positive by the Heaf test and 59% positive by the Mantoux test. Using the Mantoux test result in combination with clinical and radiographic findings 194 children were allocated to the three groups as follows: primary tuberculosis (5), chemoprophylaxis (101), no treatment (88). During follow up for a mean (range) time of 46 (11-102) months four additional cases received treatment for primary tuberculosis, two in the chemoprophylaxis group and two in the untreated group. The use of the 1 TU Mantoux test after neonatal BCG vaccination reduced the number of children receiving treatment from 129 to 93-that is, by 36%. Although the numbers are small, there was no increase in the later development of tuberculosis.

Comparative study of indirect immunofluorescence, enzyme-linked immunosorbent assay, and the Tzanck smear test for the diagnosis of pemphigus.

PubMed

Zhou, Tingting; Fang, Siyue; Li, Chunlei; Hua, Hong

2016-11-01

Pemphigus is one of the potentially fatal autoimmune blistering diseases. An early and accurate diagnosis is important for prognosis and therapy. It may be difficult to diagnosis based on clinical grounds alone. Direct and indirect immunofluorescence, enzyme-linked immunosorbent assay, the Tzanck smear test, or histopathology are all available for the diagnosis of pemphigus. However, there are no generally accepted diagnostic criteria for the diagnosis of this condition at present. To evaluate the diagnostic value of indirect immunofluorescence, enzyme-linked immunosorbent assay, and the Tzanck smear test for the diagnosis of pemphigus in dental clinics. A single-center retrospective study was conducted, and the clinical data of 33 patients with pemphigus and 61 controls were collected and analyzed from the Department of Oral Medicine, Peking University School of Stomatology, during 2010-2014. The sensitivities and specificities of indirect immunofluorescence, enzyme-linked immunosorbent assay, and the Tzanck smear test were calculated and compared in two groups. Sensitivities for the Tzanck smear test, indirect immunofluorescence, and enzyme-linked immunosorbent assay were 96.7%, 84.8%, and 84.8%, respectively, whereas the specificities of these tests were 60%, 91.8%, and 96.7%, respectively. The serial tests for the Tzanck smear test and enzyme-linked immunosorbent assay showed 82% sensitivity and 98.7% specificity. The serial test for the Tzanck smear test and enzyme-linked immunosorbent assay may represent a simple, rapid, and reliable way to definitive diagnosis of pemphigus. It is recommended as a common test for the diagnosis of pemphigus in dental clinics. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Sero-prevalence and associated risk factors for hepatitis C virus infection among voluntary counseling testing and anti retroviral treatment clinic attendants in Adwa hospital, northern Ethiopia.

PubMed

Atsbaha, Ataklti Hailu; Asmelash Dejen, Tsehaye; Belodu, Rashmi; Getachew, Konjit; Saravanan, Muthupandian; Wasihun, Araya Gebreyesus

2016-02-23

Hepatitis C virus (HCV) is a major health concern where about 3% of the world's population is infected globally. In Ethiopia the prevalence ranges from 0.9 to 1.3% in the general populations. Human immune deficiency virus (HIV) patients due to their weak immune response are heavily affected by the virus. There is no data on magnitude and associated risk factors for HCV infection among voluntary counseling, testing center and anti retroviral treatment clinic Attendants in the study area. Therefore, the aim of this study was to determine the sero-prevalence and associated risk factors for HCV infection among voluntary counseling testing and anti retroviral treatment clinic attendants Adwa general hospital. Cross sectional study was carried out among 302 participants (151 HIV-negative from VCT and 151 HIV-positive from ART follow up) clinics of Adwa hospital from September to December, 2014. About 5 ml of venous blood samples were collected from study participants for anti HCV antibody tests. Univariate analyses were used to identify associated variables with anti HCV positivity. Variables having p < 0.05 were considered as statistically significant association. Out of the total 302 participants, 52.6% of them were females and 47.4% males. The mean age of the participants was 34.1 year (SD ± 10.5). The overall sero-prevalence of HCV in this study was 4.3%. The prevalence HCV (6.6%) was higher among the ART clinic attendants than the VCT (2%) clinic attendants. History of hospitalization (p = 0.001), tooth extraction (p = 0.018) and blood transfusion (p = 0.041) showed statistically significant association with anti-HCV antibody. HCV sero-prevalence in this study was high. The prevalence was three fold higher among HIV positive patients than their counter parts. Thus, screening of HCV should be done among HIV patients for close monitoring and better management in HIV patients.

Low power and type II errors in recent ophthalmology research.

PubMed

Khan, Zainab; Milko, Jordan; Iqbal, Munir; Masri, Moness; Almeida, David R P

2016-10-01

To investigate the power of unpaired t tests in prospective, randomized controlled trials when these tests failed to detect a statistically significant difference and to determine the frequency of type II errors. Systematic review and meta-analysis. We examined all prospective, randomized controlled trials published between 2010 and 2012 in 4 major ophthalmology journals (Archives of Ophthalmology, British Journal of Ophthalmology, Ophthalmology, and American Journal of Ophthalmology). Studies that used unpaired t tests were included. Power was calculated using the number of subjects in each group, standard deviations, and α = 0.05. The difference between control and experimental means was set to be (1) 20% and (2) 50% of the absolute value of the control's initial conditions. Power and Precision version 4.0 software was used to carry out calculations. Finally, the proportion of articles with type II errors was calculated. β = 0.3 was set as the largest acceptable value for the probability of type II errors. In total, 280 articles were screened. Final analysis included 50 prospective, randomized controlled trials using unpaired t tests. The median power of tests to detect a 50% difference between means was 0.9 and was the same for all 4 journals regardless of the statistical significance of the test. The median power of tests to detect a 20% difference between means ranged from 0.26 to 0.9 for the 4 journals. The median power of these tests to detect a 50% and 20% difference between means was 0.9 and 0.5 for tests that did not achieve statistical significance. A total of 14% and 57% of articles with negative unpaired t tests contained results with β > 0.3 when power was calculated for differences between means of 50% and 20%, respectively. A large portion of studies demonstrate high probabilities of type II errors when detecting small differences between means. The power to detect small difference between means varies across journals. It is, therefore, worthwhile for authors to mention the minimum clinically important difference for individual studies. Journals can consider publishing statistical guidelines for authors to use. Day-to-day clinical decisions rely heavily on the evidence base formed by the plethora of studies available to clinicians. Prospective, randomized controlled clinical trials are highly regarded as a robust study and are used to make important clinical decisions that directly affect patient care. The quality of study designs and statistical methods in major clinical journals is improving overtime, 1 and researchers and journals are being more attentive to statistical methodologies incorporated by studies. The results of well-designed ophthalmic studies with robust methodologies, therefore, have the ability to modify the ways in which diseases are managed. Copyright © 2016 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Barriers and facilitators to reducing frequent laboratory testing for patients who are stable on warfarin: a mixed methods study of de-implementation in five anticoagulation clinics.

PubMed

Barnes, Geoffrey D; Misirliyan, Sevan; Kaatz, Scott; Jackson, Elizabeth A; Haymart, Brian; Kline-Rogers, Eva; Kozlowski, Jay; Krol, Gregory; Froehlich, James B; Sales, Anne

2017-07-14

Patients on chronic warfarin therapy require regular laboratory monitoring to safely manage warfarin. Recent studies have challenged the need for routine monthly blood draws in the most stable warfarin-treated patients, suggesting the safety of less frequent laboratory testing (up to every 12 weeks). De-implementation efforts aim to reduce the use of low-value clinical practices. To explore barriers and facilitators of a de-implementation effort to reduce the use of frequent laboratory tests for patients with stable warfarin management in nurse/pharmacist-run anticoagulation clinics, we performed a mixed-methods study conducted within a state-wide collaborative quality improvement collaborative. Using a mixed-methods approach, we conducted post-implementation semi-structured interviews with a total of eight anticoagulation nurse or pharmacist staff members at five participating clinic sites to assess barriers and facilitators to de-implementing frequent international normalized ratio (INR) laboratory testing among patients with stable warfarin control. Interview guides were based on the Tailored Implementation for Chronic Disease (TICD) framework. Informed by interview themes, a survey was developed and administered to all anticoagulation clinical staff (n = 62) about their self-reported utilization of less frequent INR testing and specific barriers to de-implementing the standard (more frequent) INR testing practice. From the interviews, four themes emerged congruent with TICD domains: (1) staff overestimating their actual use of less frequent INR testing (individual health professional factors), (2) barriers to appropriate patient engagement (incentives and resources), (3) broad support for an electronic medical record flag to identify potentially eligible patients (incentives and resources), and (4) the importance of personalized nurse/pharmacist feedback (individual health professional factors). In the survey (65% response rate), staff report offering less frequent INR testing to 56% (46-66%) of eligible patients. Most survey responders (n = 24; 60%) agreed that an eligibility flag in the electronic medical record would be very helpful. Twenty-four (60%) respondents agreed that periodic, personalized feedback on use of less frequent INR testing would also be helpful. Leveraging information system notifications, reducing additional work load burden for participating patients and providers, and providing personalized feedback are strategies that may improve adoption and utilization new policies in anticoagulation clinics that focus on de-implementation.

Clinical Experience of Using Cortical Auditory Evoked Potentials in the Treatment of Infant Hearing Loss in Australia

PubMed Central

Punch, Simone; Van Dun, Bram; King, Alison; Carter, Lyndal; Pearce, Wendy

2016-01-01

This article presents the clinical protocol that is currently being used within Australian Hearing for infant hearing aid evaluation using cortical auditory evoked potentials (CAEPs). CAEP testing is performed in the free field at two stimulus levels (65 dB sound pressure level [SPL], followed by 55 or 75 dB SPL) using three brief frequency-distinct speech sounds /m/, /ɡ/, and /t/, within a standard audiological appointment of up to 90 minutes. CAEP results are used to check or guide modifications of hearing aid fittings or to confirm unaided hearing capability. A retrospective review of 83 client files evaluated whether clinical practice aligned with the clinical protocol. It showed that most children could be assessed as part of their initial fitting program when they were identified as a priority for CAEP testing. Aided CAEPs were most commonly assessed within 8 weeks of the fitting. A survey of 32 pediatric audiologists provided information about their perception of cortical testing at Australian Hearing. The results indicated that clinical CAEP testing influenced audiologists' approach to rehabilitation and was well received by parents and that they were satisfied with the technique. Three case studies were selected to illustrate how CAEP testing can be used in a clinical environment. Overall, CAEP testing has been effectively integrated into the infant fitting program. PMID:27587921

Evaluation of a simple test of reaction time for baseline concussion testing in a population of high school athletes.

PubMed

MacDonald, James; Wilson, Julie; Young, Julie; Duerson, Drew; Swisher, Gail; Collins, Christy L; Meehan, William P

2015-01-01

A common sequela of concussions is impaired reaction time. Computerized neurocognitive tests commonly measure reaction time. A simple clinical test for reaction time has been studied previously in college athletes; whether this test is valid and reliable when assessing younger athletes remains unknown. Our study examines the reliability and validity of this test in a population of high school athletes. Cross-sectional study. Two American High Schools. High school athletes (N = 448) participating in American football or soccer during the academic years 2011 to 2012 and 2012 to 2013. All study participants completed a computerized baseline neurocognitive assessment that included a measure of reaction time (RT comp), in addition to a clinical measure of reaction time that assessed how far a standard measuring device would fall prior to the athlete catching it (RT clin). Validity was assessed by determining the correlation between RT clin and RT comp. Reliability was assessed by measuring the intraclass correlation coefficients (ICCs) between the repeated measures of RT clin and RT comp taken 1 year apart. In the first year of study, RT clin and RT comp were positively but weakly correlated (rs = 0.229, P < 0.001). In the second year, there was no significant correlation between RT clin and RT comp (rs = 0.084, P = 0.084). Both RT clin [ICC = 0.608; 95% confidence interval (CI), 0.434-0.728] and RT comp (ICC = 0.691; 95% CI, 0.554-0.786) had marginal reliability. In a population of high school athletes, RT clin had poor validity when compared with RT comp as a standard. Both RT clin and RT comp had marginal test-retest reliability. Before considering the clinical use of RT clin in the assessment of sport-related concussions sustained by high school athletes, the factors affecting reliability and validity should be investigated further. Reaction time impairment commonly results from concussion and is among the most clinically important measures of the condition. The device evaluated in this study has previously been investigated as a reaction time measure in college athletes. This study investigates the clinical generalizability of the device in a younger population. A video abstract showing how the RT clin device is used in practice is available as Supplemental Digital Content 1, http://links.lww.com/JSM/A43.

[Hot topics of circulating tumor DNA testing in breast cancer].

PubMed

Liu, Y H; Zhou, B; Xu, L; Xin, L

2017-02-01

The progress of gene detection technologies represented by next generation sequencing (NGS) and digital PCR laid a foundation for studies of circulating tumor DNA (ctDNA) in breast cancer. In 2014, the NGS workgroup organized by the College of American Pathologists (CAP) published the College of American Pathologists ' Laboratory Standards for Next - Generation Sequencing Clinical Tests, which provides a blueprint for the standardization of gene testing. In 2015, the Guidelines for Diagnostic Next - generation Sequencing published by the European Society of Human Genetics claimed that NGS is unacceptable in clinical practice before studies guided by guidelines are approved. Although existing studies show the benefits of ctDNA testing in disease monitoring and prognosis analyzing, we have a ways to go to normalize the procedure and build strict detection criteria.

The Alzheimer’s Disease Centers’ Uniform Data Set (UDS): The Neuropsychological Test Battery

PubMed Central

Weintraub, Sandra; Salmon, David; Mercaldo, Nathaniel; Ferris, Steven; Graff-Radford, Neill R.; Chui, Helena; Cummings, Jeffrey; DeCarli, Charles; Foster, Norman L.; Galasko, Douglas; Peskind, Elaine; Dietrich, Woodrow; Beekly, Duane L.; Kukull, Walter A.; Morris, John C.

2009-01-01

The neuropsychological test battery from the Uniform Data Set (UDS) of the Alzheimer’s Disease Centers (ADC) program of the National Institute on Aging (NIA) consists of brief measures of attention, processing speed, executive function, episodic memory and language. This paper describes development of the battery and preliminary data from the initial UDS evaluation of 3,268 clinically cognitively normal men and women collected over the first 24 months of utilization. The subjects represent a sample of community-dwelling, individuals who volunteer for studies of cognitive aging. Subjects were considered “clinically cognitively normal” based on clinical assessment, including the Clinical Dementia Rating scale and the Functional Assessment Questionnaire. The results demonstrate performance on tests sensitive to cognitive aging and to the early stages of Alzheimer disease (AD) in a relatively well-educated sample. Regression models investigating the impact of age, education, and gender on test scores indicate that these variables will need to be incorporated in subsequent normative studies. Future plans include: 1) determining the psychometric properties of the battery; 2) establishing normative data, including norms for different ethnic minority groups; and 3) conducting longitudinal studies on cognitively normal subjects, individuals with mild cognitive impairment, and individuals with AD and other forms of dementia. PMID:19474567

Limits of clinical tests to screen autonomic function in diabetes type 1.

PubMed

Ducher, M; Bertram, D; Sagnol, I; Cerutti, C; Thivolet, C; Fauvel, J P

2001-11-01

A precocious detection of cardiac autonomic dysfunction is of major clinical interest that could lead to a more intensive supervision of diabetic patients. However, classical clinical exploration of cardiac autonomic function is not easy to undertake in a reproducible way. Thus, respective interests of autonomic nervous parameters provided by both clinical tests and computerized analysis of resting blood pressure were checked in type 1 diabetic patients without orthostatic hypotension and microalbuminuria. Thirteen diabetic subjects matched for age and gender to thirteen healthy subjects volunteered to participate to the study. From clinical tests (standing up, deep breathing, Valsalva maneuver, handgrip test), autonomic function was scored according to Ewing's methodology. Analysis of resting beat to beat blood pressure provided autonomic indices of the cardiac function (spectral analysis or Z analysis). 5 of the 13 diabetic patients exhibited a pathological score (more than one pathological response) suggesting the presence of cardiovascular autonomic dysfunction. The most discriminative test was the deep breathing test. However, spectral indices of BP recordings and baro-reflex sensitivity (BRS) of these 5 subjects were similar to those of healthy subjects and of remaining diabetic subjects. Alteration in Ewing's score given by clinical tests may not reflect an alteration of cardiac autonomic function in asymptomatic type 1 diabetic patients, because spectral indices of sympathetic and parasympathetic (including BRS) function were within normal range. Our results strongly suggest to confront results provided by both methodologies before concluding to an autonomic cardiac impairment in asymptomatic diabetic patients.

Impact of a Routine, Opt-Out HIV Testing Program on HIV Testing and Case Detection in North Carolina Sexually-Transmitted Disease Clinics

PubMed Central

Klein, Pamela W.; Messer, Lynne C.; Myers, Evan R.; Weber, David J.; Leone, Peter A.; Miller, William C.

2016-01-01

The impact of routine, opt-out HIV testing programs in clinical settings is inconclusive. The objective of this study was to estimate the impact of an expanded, routine HIV testing program in North Carolina sexually transmitted disease (STD) clinics on HIV testing and case detection. Adults aged 18–64 who received an HIV test in a North Carolina STD clinic July 1, 2005 through June 30, 2011 were included in this analysis, dichotomized at the date of implementation on November 1, 2007. HIV testing and case detection counts and rates were analyzed using interrupted time series analysis, and Poisson and multilevel logistic regression. Pre-intervention, 426 new HIV-infected cases were identified from 128,029 tests (0.33%), whereas 816 new HIV-infected cases were found from 274,745 tests post-intervention (0.30%). Pre-intervention, HIV testing increased by 55 tests per month (95% confidence interval [CI]: 41, 72), but only 34 tests per month (95% CI: 26, 42) post-intervention. Increases in HIV testing rates were most pronounced in females and non-Hispanic whites. A slight pre-intervention decline in case detection was mitigated by the intervention (mean difference [MD]=0.01; 95% CI: −0.02, 0.05). Increases in case detection rates were observed among females and non-Hispanic blacks. The impact of a routine HIV screening in North Carolina STD clinics was marginal, with the greatest benefit among persons not traditionally targeted for HIV testing. The use of a pre-intervention comparison period identified important temporal trends that otherwise would have been ignored. PMID:24825338

Clinical history as a predictor of penicillin skin test outcome.

PubMed

Wong, Benjamin B L; Keith, Paul K; Waserman, Susan

2006-08-01

Up to 10% of the population reports an "allergy" to penicillin, whereas approximately 1.1% has positive penicillin skin test results. Where penicillin skin tests are unavailable, some have advocated using history to decide whether to use a penicillin-related antibiotic. To determine if clinical history predicts penicillin skin test results. Retrospective medical record review of 94 consecutive patients who had previously taken penicillin referred for penicillin allergy. Case histories were taken, penicillin skin tests performed, and an oral challenge recommended if skin test results were negative. Of 91 cases studied, the average patient age was 27 years (range, 6 months to 82 years; 36% female). Fifty-two (57%) experienced hives as their main adverse reaction. Sixteen (18%) had at least 1 positive test result. Of this group, 9 had hives as their main symptom, whereas 1 had respiratory problems and 1 had angioedema. Most patients with positive skin test results had experienced their reaction at least 3 years ago. Regression analysis showed that age, sex, and clinical history, including type of reaction, time of reaction after penicillin ingestion, or time since the last reaction, were not associated with skin test positivity. Seventy-two (96%) of the 75 patients who had negative skin test results underwent oral challenge. Seventy had negative challenge results. The negative predictive value of a negative penicillin skin test result was 97%. Clinical history was not predictive of subsequent penicillin skin test results.

Antibiotic therapy as an adjunct to scaling and root planing in smokers: a systematic review and meta-analysis.

PubMed

Assem, Naida Zanini; Alves, Márcio Luiz Ferro; Lopes, Alessandra Barreto; Gualberto, Erivan Clementino; Garcia, Valdir Gouveia; Theodoro, Letícia Helena

2017-07-03

The aim of this study was to perform a systematic review and meta-analysis to examine the effect of systemic antibiotics in the periodontal treatment of smokers. The selection criteria were as follows: controlled randomized clinical trials; studies published in English; studies with smoker patients diagnosed with chronic periodontitis; patients without systemic diseases; studies that used systemic antibiotic therapy associated with periodontal treatment; studies that presented results for the test and control groups and assessments of clinical periodontal parameters, such as probing depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL). The differences in average weights were calculated with a confidence interval (CI) of 95% for PD reduction, CAL gain and BOP. The means of the periodontal clinical parameters were compared between the baseline and post-treatment periods between the test groups and the control groups. The heterogeneity was assessed using the Cochran Q test (Q (df = 3), α = 5%). A total of 67 articles were found, and after the selection process, three randomized controlled trials were included in the meta-analysis. The results indicate that SRP associated with systemic antibiotics promoted additional benefits when compared to SRP alone, with a greater reduction of PD (p = 0.0359, CI = -0.42, -0.01) and a gain of CAL (p = 0.0161, CI = -0.39, -0.04). There was a modest PD reduction (PD, DM -0.21) and a modest CAL gain (CAL, DM -0.22). The results of our meta-analysis reveal the clinical benefits of systemic antibiotics as an adjunct to the non-surgical periodontal treatment of smokers. These clinical improvements, although statistically significant, appeared to be of little clinical relevance.

Evidence for Trait Related Theory of Mind Impairment in First Episode Psychosis Patients and Its Relationship with Processing Speed: A 3 Year Follow-up Study.

PubMed

Ayesa-Arriola, Rosa; Setién-Suero, Esther; Neergaard, Karl D; Ferro, Adele; Fatjó-Vilas, Mar; Ríos-Lago, Marcos; Otero, Soraya; Rodríguez-Sánchez, Jose M; Crespo-Facorro, Benedicto

2016-01-01

This study aimed to confirm whether first-episode psychosis patients present a stable trait impairment in theory of mind (ToM) and to examine the potential relationship between ToM and clinical symptomatology and neurocognition. Patients with a first episode of psychosis (N = 160) and healthy controls (N = 159) were assessed with an extensive neuropsychological test battery, which included a mental state decoding task known as "The Reading the Mind in the Eyes" (Eyes test), at baseline and reassessed after 1 and 3 years. The clinical group performed below healthy controls on the Eyes test while not showing test-retest differences between baseline and follow-up administrations. Analyses revealed age, education and premorbid IQ as potential moderators. Poorer performance on the Eyes test was not linked to clinical symptomatology but was associated with greater neurocognitive deficit, particularly related to processing speed. The persistence of ToM deficits in patients suggests that there are trait related metalizing impairments in first episode psychosis. This study shows the influence of processing speed and moderator variables on efficient ToM.

Evidence for Trait Related Theory of Mind Impairment in First Episode Psychosis Patients and Its Relationship with Processing Speed: A 3 Year Follow-up Study

PubMed Central

Ayesa-Arriola, Rosa; Setién-Suero, Esther; Neergaard, Karl D.; Ferro, Adele; Fatjó-Vilas, Mar; Ríos-Lago, Marcos; Otero, Soraya; Rodríguez-Sánchez, Jose M.; Crespo-Facorro, Benedicto

2016-01-01

This study aimed to confirm whether first-episode psychosis patients present a stable trait impairment in theory of mind (ToM) and to examine the potential relationship between ToM and clinical symptomatology and neurocognition. Patients with a first episode of psychosis (N = 160) and healthy controls (N = 159) were assessed with an extensive neuropsychological test battery, which included a mental state decoding task known as “The Reading the Mind in the Eyes” (Eyes test), at baseline and reassessed after 1 and 3 years. The clinical group performed below healthy controls on the Eyes test while not showing test-retest differences between baseline and follow-up administrations. Analyses revealed age, education and premorbid IQ as potential moderators. Poorer performance on the Eyes test was not linked to clinical symptomatology but was associated with greater neurocognitive deficit, particularly related to processing speed. The persistence of ToM deficits in patients suggests that there are trait related metalizing impairments in first episode psychosis. This study shows the influence of processing speed and moderator variables on efficient ToM. PMID:27199826

Nonclinical safety testing of biopharmaceuticals--Addressing current challenges of these novel and emerging therapies.

PubMed

Brennan, Frank R; Baumann, Andreas; Blaich, Guenter; de Haan, Lolke; Fagg, Rajni; Kiessling, Andrea; Kronenberg, Sven; Locher, Mathias; Milton, Mark; Tibbitts, Jay; Ulrich, Peter; Weir, Lucinda

2015-10-01

Non-clinical safety testing of biopharmaceuticals can present significant challenges to human risk assessment with these often innovative and complex drugs. Hot Topics in this field were discussed recently at the 4th Annual European Biosafe General Membership meeting. In this feature article, the presentations and subsequent discussions from the main sessions are summarized. The topics covered include: (i) wanted versus unwanted immune activation, (ii) bi-specific protein scaffolds, (iii) use of Pharmacokinetic (PK)/Pharmacodynamic (PD) data to impact/optimize toxicology study design, (iv) cytokine release and challenges to human translation (v) safety testing of cell and gene therapies including chimeric antigen receptor T (CAR-T) cells and retroviral vectors and (vi) biopharmaceutical development strategies encompassing a range of diverse topics including optimizing entry of monoclonal antibodies (mAbs) into the brain, safety testing of therapeutic vaccines, non-clinical testing of biosimilars, infection in toxicology studies with immunomodulators and challenges to human risk assessment, maternal and infant anti-drug antibody (ADA) development and impact in non-human primate (NHP) developmental toxicity studies, and a summary of an NC3Rs workshop on the future vision for non-clinical safety assessment of biopharmaceuticals. Copyright © 2015 Elsevier Inc. All rights reserved.

Initial report of a hepatitis investigation in rural Belize.

PubMed

Hoffman, K J; Gaydos, J C; Krieg, R E; Duncan, J F; MacArthy, P O; Ticehurst, J R; Jaramillo, R; Reyes, L G; Sjogren, M H; Legters, L J

1993-01-01

In spring 1991, Belizian health officials expressed concern about a possible hepatitis outbreak in a banana farming district. A study was designed to identify cases and to address the serological prevalence of hepatitis virus markers. Three populations were studied: (i) persons meeting a clinical case definition for hepatitis; (ii) designated banana workers; and (iii) people in a random sample of households in the community. Information was collected using questionnaires and sera were collected for laboratory testing. This report presents the preliminary results of a study conducted in June 1991. Among people who met the clinical case definition, 24% of 42 tested had immunoglobulin M antibody to hepatitis B virus (HBV) core antigen (anti-HBc IgM). In the worker and household survey populations, 284 and 280 people, respectively, were tested for anti-HBc IgM. In each group, 4% were positive. HBV surface antigen was found in 37% of 43 clinical cases, 18% of workers, and 13% of people in the household survey. Among the 3 study populations, the prevalence of HBV core antibody (anti-HBc) ranged from 73% to 81%. Almost all tested persons had evidence of prior hepatitis A virus infection. Evidence of prior infection with hepatitis viruses A and B was widespread, but an aetiology could not be established for most of the clinical cases. However, the prevalence of hepatitis B markers in this population was very high compared to other reports from the Caribbean.

Tetherless ergonomics workstation to assess nurses' physical workload in a clinical setting.

PubMed

Smith, Warren D; Nave, Michael E; Hreljac, Alan P

2011-01-01

Nurses are at risk of physical injury when moving immobile patients. This paper describes the development and testing of a tetherless ergonomics workstation that is suitable for studying nurses' physical workload in a clinical setting. The workstation uses wearable sensors to record multiple channels of body orientation and muscle activity and wirelessly transmits them to a base station laptop computer for display, storage, and analysis. In preparation for use in a clinical setting, the workstation was tested in a laboratory equipped for multi-camera video motion analysis. The testing included a pilot study of the effect of bed height on student nurses' physical workload while they repositioned a volunteer posing as a bedridden patient toward the head of the bed. Each nurse subject chose a preferred bed height, and data were recorded, in randomized order, with the bed at this height, at 0.1 m below this height, and at 0.1 m above this height. The testing showed that the body orientation recordings made by the wearable sensors agreed closely with those obtained from the video motion analysis system. The pilot study showed the following trends: As the bed height was raised, the nurses' trunk flexion at both thoracic and lumbar sites and lumbar muscle effort decreased, whereas trapezius and deltoid muscle effort increased. These trends will be evaluated by further studies of practicing nurses in the clinical setting.

A concise evidence-based physical examination for diagnosis of acromioclavicular joint pathology: a systematic review.

PubMed

Krill, Michael K; Rosas, Samuel; Kwon, KiHyun; Dakkak, Andrew; Nwachukwu, Benedict U; McCormick, Frank

2018-02-01

The clinical examination of the shoulder joint is an undervalued diagnostic tool for evaluating acromioclavicular (AC) joint pathology. Applying evidence-based clinical tests enables providers to make an accurate diagnosis and minimize costly imaging procedures and potential delays in care. The purpose of this study was to create a decision tree analysis enabling simple and accurate diagnosis of AC joint pathology. A systematic review of the Medline, Ovid and Cochrane Review databases was performed to identify level one and two diagnostic studies evaluating clinical tests for AC joint pathology. Individual test characteristics were combined in series and in parallel to improve sensitivities and specificities. A secondary analysis utilized subjective pre-test probabilities to create a clinical decision tree algorithm with post-test probabilities. The optimal special test combination to screen and confirm AC joint pathology combined Paxinos sign and O'Brien's Test, with a specificity of 95.8% when performed in series; whereas, Paxinos sign and Hawkins-Kennedy Test demonstrated a sensitivity of 93.7% when performed in parallel. Paxinos sign and O'Brien's Test demonstrated the greatest positive likelihood ratio (2.71); whereas, Paxinos sign and Hawkins-Kennedy Test reported the lowest negative likelihood ratio (0.35). No combination of special tests performed in series or in parallel creates more than a small impact on post-test probabilities to screen or confirm AC joint pathology. Paxinos sign and O'Brien's Test is the only special test combination that has a small and sometimes important impact when used both in series and in parallel. Physical examination testing is not beneficial for diagnosis of AC joint pathology when pretest probability is unequivocal. In these instances, it is of benefit to proceed with procedural tests to evaluate AC joint pathology. Ultrasound-guided corticosteroid injections are diagnostic and therapeutic. An ultrasound-guided AC joint corticosteroid injection may be an appropriate new standard for treatment and surgical decision-making. II - Systematic Review.

Special Physical Examination Tests for Superior Labrum Anterior-Posterior Shoulder Tears: An Examination of Clinical Usefulness

PubMed Central

Sandrey, Michelle A.

2013-01-01

Reference/Citation: Calvert E, Chambers GK, Regan W, Hawkins RH, Leith JM. Special physical examination tests for superior labrum anterior-posterior shoulder injuries are clinically limited and invalid: a diagnostic systematic review. J Clin Epidemiol. 2009;62(5):558–563. Clinical Question: The systematic review focused on diagnostic accuracy studies to determine if evidence was sufficient to support the use of superior labrum anterior-posterior (SLAP) physical examination tests as valid and reliable. The primary question was whether there was sufficient evidence in the published literature to support the use of SLAP physical examination tests as valid and reliable diagnostic test procedures. Data Sources: Studies published in English were identified through database searches on MEDLINE, EMBASE, and the Cochrane database (1970–2004) using the search term SLAP lesions. The medical subject headings of arthroscopy, shoulder joint, and athletic injuries were combined with test or testing, physical examination, and sensitivity and specificity to locate additional sources. Other sources were identified by rereviewing the reference lists of included studies and review articles. Study Selection: Studies were eligible based on the following criteria: (1) published in English, (2) focused on the physical examination of SLAP lesions, and (3) presented original data. A study was excluded if the article was limited to a clinical description of 1 or more special tests without any research focus to provide clinical accuracy data or if it did not focus on the topic. Data Extraction: The abstracts that were located through the search strategies were reviewed, and potentially relevant abstracts were selected. Strict epidemiologic methods were used to obtain and collate all relevant studies; the authors developed a study questionnaire to record study name, year of publication, study design, sample size, and statistics. Validity of the diagnostic test study was determined by applying the 5 criteria proposed by Calvert et al. If the study met the inclusion and validity criteria, 95% confidence intervals were calculated for each sensitivity, specificity, and positive and negative likelihood ratio reported. No specific information was provided about the procedure if the reviewers disagreed on how the evaluation criteria were applied. Main Results: The specific search criteria led to the identification of 29 full-text articles. The studies were reviewed, and inclusion and exclusion criteria were applied. This resulted in 14 excluded studies and 15 eligible studies for analysis. Of the 15 eligible studies, 1 evaluated only a single physical examination test for a SLAP lesion or biceps tendon injury, and 10 studies evaluated 2 to 6 physical examination tests for a SLAP lesion or biceps tendon injury. Nine studies reported sensitivities and specificities greater than 75%, 4 had sensitivities less than 75%, 3 had specificities less than 75%, 1 did not report sensitivity, and 2 did not report specificities. When validity was assessed for those 15 papers, only 1 study that evaluated the biceps tendon met the 5 critical appraisal criteria of Calvert et al and calculated 95% confidence intervals. When the Speed and Yergason tests were each compared with the gold standard (arthroscopy), the confidence intervals for the positive and negative likelihood ratios spanned 1. This indicated that the test result is unlikely to change the odds of having or not having the condition, respectively. Conclusions: The literature currently used as a reference for teaching in medical schools and continuing education lacks the necessary validity to help rule in or out a SLAP lesion or biceps tendon involvement. Based on the results from the systematic review conducted by Calvert et al, no tests clinically diagnose a SLAP lesion. This is a cause for concern as magnetic resonance imaging or magnetic resonance arthrography, which are frequently used to assess a possible SLAP lesion, may also have diagnostic flaws and may be cost prohibitive. Performing arthroscopy on every patient to rule the condition in or out is unethical, especially if a SLAP lesion is not present. More rigorous validity studies should be conducted for SLAP lesion physical examination tests using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) tool or Standards for Reporting Diagnostic Accuracy (STARD) criteria. PMID:23914880

How to: evaluate a diagnostic test.

PubMed

Leeflang, Mariska M G; Allerberger, Franz

2018-06-12

The development of an in vitro diagnostic test from a good idea to a clinically relevant tool takes several steps, with more stringent requirements at every step. This article aims to summarize the necessary questions to be asked about a test and to illustrate study designs answering these questions. We also aim to relate the Regulation (EU) 2017/746 to the needs of evidence-based diagnostic testing, where applicable. We used literature on evidence-based diagnostics, a text book on clinical trials in the development and marketing of medical devices and the English version of Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices. The combination of different test uses and different stages of development determine the required test characteristics and suitability of study designs. In an earlier stage of test development it may be crucial to know whether a test can differentiate diseased persons from healthy controls, while this tells us little about how a test will perform in practice. Later stages focus on the diagnostic accuracy of a test in a clinically relevant situation. However, a test that perfectly distinguishes between patients with and without a certain condition may still have little effect on patient outcomes. Therefore, randomized controlled trials of testing may be needed, as well as post-marketing monitoring. Both researchers and users of tests need to be aware of the limitations of diagnostic test accuracy and realize that accuracy is only indirectly linked to people's health status. Copyright © 2018. Published by Elsevier Ltd.

Use of anti-mullerian hormone for testing ovarian reserve: a survey of 796 infertility clinics worldwide.

PubMed

Tobler, Kyle J; Shoham, Gon; Christianson, Mindy S; Zhao, Yulian; Leong, Milton; Shoham, Zeev

2015-10-01

The aim of this study is to assess how anti-mullerian hormone (AMH) is used worldwide to test ovarian reserve and guide in vitro fertilization (IVF) cycle management. An internet-based survey was sent electronically to registered IVF providers within the IVF-Worldwide.com network. This survey consisted of nine questions which assessed the clinics' use of AMH. The questionnaire was completed online through the IVF-Worldwide.com website, and quality assurance tools were used to verify that only one survey was completed per clinical IVF center. Results are reported as the proportion of IVF cycles represented by a particular answer choice. Survey responses were completed from 796 globally distributed IVF clinics, representing 593,200 IVF cycles worldwide. Sixty percent of the respondent-IVF cycles reported to use AMH as a first line test, and 54 % reported it as the best test for evaluating ovarian reserve. Eighty-nine percent reported that AMH results were extremely relevant or relevant to clinical practice. However in contrast, for predicting live birth rate, 81 % reported age as the best predictor. AMH is currently considered a first line test for evaluating ovarian reserve and is considered relevant to clinical practice by the majority of IVF providers.

HIS-Based Support of Follow-Up Documentation – Concept and Implementation for Clinical Studies

PubMed Central

Herzberg, S.; Fritz, F.; Rahbar, K.; Stegger, L.; Schäfers, M.; Dugas, M.

2011-01-01

Objective Follow-up data must be collected according to the protocol of each clinical study, i.e. at certain time points. Missing follow-up information is a critical problem and may impede or bias the analysis of study data and result in delays. Moreover, additional patient recruitment may be necessary due to incomplete follow-up data. Current electronic data capture (EDC) systems in clinical studies are usually separated from hospital information systems (HIS) and therefore can provide limited functionality to support clinical workflow. In two case studies, we assessed the feasibility of HIS-based support of follow-up documentation. Methods We have developed a data model and a HIS-based workflow to provide follow-up forms according to clinical study protocols. If a follow-up form was due, a database procedure created a follow-up event which was translated by a communication server into an HL7 message and transferred to the import interface of the clinical information system (CIS). This procedure generated the required follow-up form and enqueued a link to it in a work list of the relating study nurses and study physicians, respectively. Results A HIS-based follow-up system automatically generated follow-up forms as defined by a clinical study protocol. These forms were scheduled into work lists of study nurses and study physicians. This system was integrated into the clinical workflow of two clinical studies. In a study from nuclear medicine, each scenario from the test concept according to the protocol of the single photon emission computer tomography/computer tomography (SPECT/CT) study was simulated and each scenario passed the test. For a study in psychiatry, 128 follow-up forms were automatically generated within 27 weeks, on average five forms per week (maximum 12, minimum 1 form per week). Conclusion HIS-based support of follow-up documentation in clinical studies is technically feasible and can support compliance with study protocols. PMID:23616857

Assessment of the diagnostic value of a urinary adipsin rapid strip test for pre-eclampsia: A prospective multicenter study.

PubMed

Peng, Bing; Zhang, Li; Yan, Jianying; Qi, Hongbo; Zhang, Weiyuan; Fan, Ling; Hu, Yayi; Lin, Li; Li, Xiaotian; Hu, Rong; Xie, Lan; Zhang, Jianping; Wu, Yanqiao; Li, Li; Zhou, Rong

2017-01-01

The purpose of the present study was to evaluate the clinical value of the rapid strip test of urinary adipsin for the quick diagnosis of pre-eclampsia. In a multicenter diagnostic test study, we studied the diagnostic accuracy of the rapid strip test of urinary adipsin in women presenting with pre-eclampsia. A total of 204 pre-eclampsia patients and 254 healthy pregnant women were recruited for this study, respectively. The rapid strip test of urinary adipsin was used to detect the adipsin in the urine of each patient. The diagnostic value of the rapid strip test of urinary adipsin for pre-eclampsia was demonstrated by its high sensitivity and specificity (95.10% and 97.64%, respectively). The diagnostic accuracy was 96.51%. The consistency analysis showed that the kappa value was 0.93 compared with the gold standard diagnosis of pre-eclampsia. The rapid strip test of urinary adipsin is a non-invasive test for the diagnosis of pre-eclampsia with high sensitivity and specificity. It could help the quick diagnosis of pre-eclampsia in clinical practice greatly. © 2016 Japan Society of Obstetrics and Gynecology.

A Clinically Meaningful Interpretation of the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) II and III Data.

PubMed

Cronin, Paul; Dwamena, Ben A

2018-05-01

This study aimed to calculate the multiple-level likelihood ratios (LRs) and posttest probabilities for a positive, indeterminate, or negative test result for multidetector computed tomography pulmonary angiography (MDCTPA) ± computed tomography venography (CTV) and magnetic resonance pulmonary angiography (MRPA) ± magnetic resonance venography (MRV) for each clinical probability level (two-, three-, and four-level) for the nine most commonly used clinical prediction rules (CPRs) (Wells, Geneva, Miniati, and Charlotte). The study design is a review of observational studies with critical review of multiple cohort studies. The settings are acute care, emergency room care, and ambulatory care (inpatients and outpatients). Data were used to estimate pulmonary embolism (PE) pretest probability for each of the most commonly used CPRs at each probability level. Multiple-level LRs (positive, indeterminate, negative test) were generated and used to calculate posttest probabilities for MDCTPA, MDCTPA + CTV, MRPA, and MRPA + MRV from sensitivity and specificity results from Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) II and PIOPED III for each clinical probability level for each CPR. Nomograms were also created. The LRs for a positive test result were higher for MRPA compared to MDCTPA without venography (76 vs 20) and with venography (42 vs 18). LRs for a negative test result were lower for MDCTPA compared to MRPA without venography (0.18 vs 0.22) and with venography (0.12 vs 0.15). In the three-level Wells score, the pretest clinical probability of PE for a low, moderate, and high clinical probability score is 5.7, 23, and 49. The posttest probability for an initially low clinical probability PE for a positive, indeterminate, and negative test result, respectively, for MDCTPA is 54, 5 and 1; for MDCTPA + CTV is 52, 2, and 0.7; for MRPA is 82, 6, and 1; and for MRPA + MRV is 72, 3, and 1; for an initially moderate clinical probability PE for MDCTPA is 86, 22, and 5; for MDCTPA + CTV is 85, 10, and 4; for MRPA is 96, 25, and 6; and for MRPA + MRV is 93, 14, and 4; and for an initially high clinical probability of PE for MDCTPA is 95, 47, and 15; for MDCTPA + CTV is 95, 27, and 10; for MRPA is 99, 52, and 17; and for MRPA + MRV is 98, 34, and 13. For a positive test result, LRs were considerably higher for MRPA compared to MDCTPA. However, both a positive MRPA and MDCTPA have LRs >10 and therefore can confirm the presence of PE. Performing venography reduced the LR for a positive and negative test for both MDCTPA and MRPA. The nomograms give posttest probabilities for a positive, indeterminate, or negative test result for MDCTPA and MRPA (with and without venography) for each clinical probability level for each of the CPR. Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Development and psychometric testing of a Clinical Reasoning Evaluation Simulation Tool (CREST) for assessing nursing students' abilities to recognize and respond to clinical deterioration.

PubMed

Liaw, Sok Ying; Rashasegaran, Ahtherai; Wong, Lai Fun; Deneen, Christopher Charles; Cooper, Simon; Levett-Jones, Tracy; Goh, Hongli Sam; Ignacio, Jeanette

2018-03-01

The development of clinical reasoning skills in recognising and responding to clinical deterioration is essential in pre-registration nursing education. Simulation has been increasingly used by educators to develop this skill. To develop and evaluate the psychometric properties of a Clinical Reasoning Evaluation Simulation Tool (CREST) for measuring clinical reasoning skills in recognising and responding to clinical deterioration in a simulated environment. A scale development with psychometric testing and mixed methods study. Nursing students and academic staff were recruited at a university. A three-phase prospective study was conducted. Phase 1 involved the development and content validation of the CREST; Phase 2 included the psychometric testing of the tool with 15 second-year and 15 third-year nursing students who undertook the simulation-based assessment; Phase 3 involved the usability testing of the tool with nine academic staff through a survey questionnaire and focus group discussion. A 10-item CREST was developed based on a model of clinical reasoning. A content validity of 0.93 was obtained from the validation of 15 international experts. The construct validity was supported as the third-year students demonstrated significantly higher (p<0.001) clinical reasoning scores than the second-year students. The concurrent validity was also supported with significant positive correlations between global rating scores and almost all subscale scores, and the total scores. The predictive validity was supported with an existing tool. The internal consistency was high with a Cronbach's alpha of 0.92. A high inter-rater reliability was demonstrated with an intraclass correlation coefficient of 0.88. The usability of the tool was rated positively by the nurse educators but the need to ease the scoring process was highlighted. A valid and reliable tool was developed to measure the effectiveness of simulation in developing clinical reasoning skills for recognising and responding to clinical deterioration. Copyright © 2017. Published by Elsevier Ltd.

Evaluation of LOINC for Representing Constitutional Cytogenetic Test Result Reports

PubMed Central

Heras, Yan Z.; Mitchell, Joyce A.; Williams, Marc S.; Brothman, Arthur R.; Huff, Stanley M.

2009-01-01

Genetic testing is becoming increasingly important to medical practice. Integrating genetics and genomics data into electronic medical records is crucial in translating genetic discoveries into improved patient care. Information technology, especially Clinical Decision Support Systems, holds great potential to help clinical professionals take full advantage of genomic advances in their daily medical practice. However, issues relating to standard terminology and information models for exchanging genetic testing results remain relatively unexplored. This study evaluates whether the current LOINC standard is adequate to represent constitutional cytogenetic test result reports using sample result reports from ARUP Laboratories. The results demonstrate that current standard terminology is insufficient to support the needs of coding cytogenetic test results. The terminology infrastructure must be developed before clinical information systems will be able to handle the high volumes of genetic data expected in the near future. PMID:20351857

Evaluation of LOINC for representing constitutional cytogenetic test result reports.

PubMed

Heras, Yan Z; Mitchell, Joyce A; Williams, Marc S; Brothman, Arthur R; Huff, Stanley M

2009-11-14

Genetic testing is becoming increasingly important to medical practice. Integrating genetics and genomics data into electronic medical records is crucial in translating genetic discoveries into improved patient care. Information technology, especially Clinical Decision Support Systems, holds great potential to help clinical professionals take full advantage of genomic advances in their daily medical practice. However, issues relating to standard terminology and information models for exchanging genetic testing results remain relatively unexplored. This study evaluates whether the current LOINC standard is adequate to represent constitutional cytogenetic test result reports using sample result reports from ARUP Laboratories. The results demonstrate that current standard terminology is insufficient to support the needs of coding cytogenetic test results. The terminology infrastructure must be developed before clinical information systems will be able to handle the high volumes of genetic data expected in the near future.

Outcomes of and risk factors for presumed canine H3N2 influenza virus infection in a metropolitan outbreak.

PubMed

Dunn, Danielle; Creevy, Kate E; Krimer, Paula M

2018-04-15

OBJECTIVE To determine clinical signs, case fatality rate, and factors associated with positive results of PCR testing for canine influenza virus (CIV) in dogs during an H3N2 CIV outbreak in the Atlanta area. DESIGN Cross-sectional study. ANIMALS 220 dogs with a nasal swab specimen submitted to an Atlanta-area diagnostic laboratory between May 1 and July 2, 2015, for PCR assay detection of CIV specifically or CIV and 5 other respiratory pathogens. PROCEDURES Veterinarians of tested dogs were surveyed by various means to collect information regarding clinical signs, survival status at the time of survey completion, vaccination history (≤ 12 months prior to testing), and travel history (≤ 2 months prior to testing). Data were compared between CIV-positive and CIV-negative dogs. RESULTS Surveys for 120 (55%) dogs were completed. Forty (33%) of these dogs had positive results of CIV testing. No significant differences were identified between CIV-positive and CIV-negative dogs regarding breed, sex, reproductive status, duration of clinical signs prior to testing, other dogs in the household, or travel history. When other factors were controlled for, CIV-positive dogs were more likely to be adult (> 1 year of age) than juvenile (≤ 1 year of age) and to be inappetent. Only 1 (3%) CIV-positive dog died during the study period (shortly after it was evaluated because of respiratory signs). CONCLUSIONS AND CLINICAL RELEVANCE From May 1 to July 2, 2015, the reported clinical signs of dogs tested during the Georgia H3N2 CIV outbreak were similar to those reported for dogs with H3N8 CIV infection, and the case fatality rate was low.

Celiac disease in non-clinical populations of Japan.

PubMed

Fukunaga, Mai; Ishimura, Norihisa; Fukuyama, Chika; Izumi, Daisuke; Ishikawa, Nahoko; Araki, Asuka; Oka, Akihiko; Mishiro, Tomoko; Ishihara, Shunji; Maruyama, Riruke; Adachi, Kyoichi; Kinoshita, Yoshikazu

2018-02-01

Celiac disease is a chronic autoimmune enteropathy caused by gluten ingestion. While its prevalence in Western countries is reported to be as high as 1%, the prevalence has not been evaluated in a large-scale study of a Japanese population. The aim of our study was to clarify the possible presence of celiac disease in a Japanese non-clinical population as well as in patients showing symptoms suggestive of the disease. Serum samples were collected from 2008 non-clinical adults and 47 patients with chronic unexplained abdominal symptoms between April 2014 and June 2016. The anti-tissue transglutaminase (TTG) immunoglobulin A antibody titer was determined as a screening test for celiac disease in all subjects, and individuals with a value of >2 U/mL subsequently underwent testing for the presence of serum endomysial IgA antibody (EMA) as confirmation. Those testing positive for EMA or with a high concentration (>10 U/mL) of TTG were further investigated by histopathological examinations of duodenal mucosal biopsy specimens and HLA typing tests. Of the 2008 non-clinical adults from whom serum samples were collected, 161 tested positive for TTG, and all tested negative for EMA. Four subjects who had a high TTG titer were invited to undergo confirmatory testing, and the histopathological results confirmed the presence of celiac disease in only a single case (0.05%). Of the 47 symptomatic patients, one (2.1%) was found to have a high TTG titer and was diagnosed with celiac disease based on duodenal histopathological findings. The presence of celiac disease in a non-clinical Japanese population was low at 0.05% and was rarely found in patients with unexplained chronic abdominal symptoms.

Imaging tests in staging and surveillance of non-metastatic breast cancer: changes in routine clinical practice and cost implications.

PubMed

De Placido, S; De Angelis, C; Giuliano, M; Pizzi, C; Ruocco, R; Perrone, V; Bruzzese, D; Tommasielli, G; De Laurentiis, M; Cammarota, S; Arpino, G; Arpino, G

2017-03-14

Although guidelines do not recommend computerised tomography (CT), positron emission tomography (PET) or magnetic resonance imaging (MRI) for the staging or follow-up of asymptomatic patients with non-metastatic breast cancer, they are often requested in routine clinical practice. The aim of this study was to determine the staging and follow-up patterns, and relative costs in a large population of breast cancer patients living and treated in a Southern Italian region. We analysed the clinical computerised information recorded by 567 primary-care physicians assisting about 650 000 inhabitants in the Campania region. Patients with non-metastatic breast cancer were identified and divided into calendar years from 2001 to 2010. The number of diagnostic tests prescribed per 100 patients (N/Pts) and the mean cost per patient was determined 3 months before diagnosis and up to 1 year after diagnosis. Costs are expressed in constant 2011 euros. We identified 4680 newly diagnosed cases of asymptomatic non-metastatic breast cancer. N/Pts increased significantly (P<0.0001) from 2001 to 2010. The mean number of prescribed mammograms, bone scans, abdominal ultrasound and chest X-rays ('routine tests'), and costs was unchanged. However, the number of CT, PET scans and MRI ('new tests')prescriptions almost quadrupled and the mean cost per patient related to these procedures significantly increased from [euro ]357 in 2001 to [euro ]830 in 2010 (P<0.0001). New test prescriptions and relative costs significantly and steadily increased throughout the study period. At present there is no evidence that the delivery of new tests to asymptomatic patients improves breast cancer outcome. Well-designed clinical trials are urgently needed to shed light on the impact of these tests on clinical outcome and overall survival.

[Development and Effects of Assertiveness Training applying Dongsasub Training for Nursing Students in Clinical Practice].

PubMed

Kim, Myoungsuk

2016-08-01

This study was conducted to develop assertiveness training applying Dongsasub training for junior nursing students, and to verify effectiveness of the training on assertiveness behavior, self-esteem, clinical practice stress, and clinical competence. The study design was a non-equivalent control group non-synchronized design. Participants were 63 nursing students in clinical training (31 students in the experimental group and 32 students in the control group). The assertiveness training applying Dongsasub training consisted of four sessions. Outcome variables included assertiveness behavior, self-esteem, clinical practice stress, and clinical competence. Data were analyzed using Chi-square, Fisher's exact test and independent samples t-test with SPSS/WIN 21.0. Scores of assertiveness behavior (t=-2.49, p=.015), self-esteem (t=-4.80, p<.001) and clinical competence (t=-2.33, p=.023) were significantly higher and clinical practice stress (t=4.22, p<.001) was significantly lower in the experimental group compared to the control group. Results indicate that the assertiveness training applying Dongsasub training can be used as a nursing intervention to lower clinical practice stress and improve the clinical competence of nursing students.

A critical evaluation of developmental and reproductive toxicology in nonhuman primates.

PubMed

Faqi, Ali S

2012-02-01

The nonhuman primates (NHPs) are used in many areas of biomedical research where their similarities to humans make them exclusively valuable animal models. The use of NHPs in pre-clinical testing is expected to increase due to the increase in the development of biological compounds for therapeutic uses. The regulatory agencies around the world including Food and Drug Administration (FDA) generally requires developmental and reproductive toxicity (DART) testing of all new drugs to be used by women of childbearing age or men of reproductive potential. NHPs are most frequently used for DART testing when commonly used rodents and/or rabbits are not pharmacologically relevant species. Animal studies are unique in that assessment of reproduction and development as DART studies are not performed in controlled clinical trials; therefore, pre-clinical safety assessment forms the basis for risk assessment for marketed drug products. This paper provides a critical evaluation of developmental and reproductive toxicity studies in NHPs. The manuscript will focus on species selection, limitation of International Conference for Harmonization stages (A-F) using NHPs as a test system, study designs, logistical/technical challenges, and strength, and limitations. It will also pinpoint confounding factors inherent to the test system that may complicate the interpretation of the NHP DART data.

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

PubMed

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

2017-09-01

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. 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. 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. 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.

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

Web-Based Activity Within a Sexual Health Economy: Observational Study.

PubMed

Turner, Katy Me; Zienkiewicz, Adam K; Syred, Jonathan; Looker, Katharine J; de Sa, Joia; Brady, Michael; Free, Caroline; Holdsworth, Gillian; Baraitser, Paula

2018-03-07

Regular testing for sexually transmitted infections (STIs) is important to maintain sexual health. Self-sampling kits ordered online and delivered in the post may increase access, convenience, and cost-effectiveness. Sexual health economies may target limited resources more effectively by signposting users toward Web-based or face-to-face services according to clinical need. The aim of this paper was to investigate the impact of two interventions on testing activity across a whole sexual health economy: (1) the introduction of open access Web-based STI testing services and (2) a clinic policy of triage and signpost online where users without symptoms who attended clinics for STI testing were supported to access the Web-based service instead. Data on attendances at all specialist public sexual health providers in an inner-London area were collated into a single database. Each record included information on user demographics, service type accessed, and clinical activity provided, including test results. Clinical activity was categorized as a simple STI test (could be done in a clinic or online), a complex visit (requiring face-to-face consultation), or other. Introduction of Web-based services increased total testing activity across the whole sexual health economy by 18.47% (from 36,373 to 43,091 in the same 6-month period-2014-2015 and 2015-2016), suggesting unmet need for testing in the area. Triage and signposting shifted activity out of the clinic onto the Web-based service, with simple STI testing in the clinic decreasing from 16.90% (920/5443) to 12.25% (511/4172) of total activity, P<.001, and complex activity in the clinic increasing from 69.15% (3764/5443) to 74.86% (3123/4172) of total activity, P<.001. This intervention created a new population of online users with different demographic and clinical profiles from those who use Web-based services spontaneously. Some triage and signposted users (29.62%, 375/1266) did not complete the Web-based testing process, suggesting the potential for missed diagnoses. This evaluation shows that users can effectively be transitioned from face-to-face to Web-based services and that this introduces a new population to Web-based service use and changes the focus of clinic-based activity. Further development is underway to optimize the triage and signposting process to support test completion. ©Katy ME Turner, Adam K Zienkiewicz, Jonathan Syred, Katharine J Looker, Joia de Sa, Michael Brady, Caroline Free, Gillian Holdsworth, Paula Baraitser. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 07.03.2018.

Prior HIV testing among STD patients in Guangdong Province, China: opportunities for expanding detection of sexually transmitted HIV infection.

PubMed

Tucker, Joseph D; Yang, Li-Gang; Yang, Bin; Young, Darwin; Henderson, Gail E; Huang, Shu-Jie; Lu, He-Kun; Chen, Xiang-Sheng; Cohen, Myron S

2012-03-01

Expanding HIV testing is important among individuals at increased risk for sexual HIV transmission in China, but little is known about prior HIV testing experiences among sexually transmitted disease (STD) patients. This cross-sectional study of 1792 outpatients from 6 public STD clinics in Guangdong Province recorded detailed information about ever having been tested for HIV infection in addition to sociodemographic variables, health seeking, clinical STD history, and HIV stigma using a validated survey instrument. A total of 456 (25.4%) of the STD patients in this sample had ever been tested for HIV infection. STD patients who were male, had higher income, more education, were at City A and City C, received STD services at public facilities, had used intravenous drugs, and had a history of an STD were more likely to ever receive an HIV test in multivariate analysis. Low perceived HIV risk was the most common reason for not receiving an HIV test. Only 7.7% of the sample reported fear of discrimination or loss of face as influencing their lack of HIV testing. Incomplete prior HIV screening among STD patients in China suggests the need for broadening HIV testing opportunities at STD clinics and similar clinical settings attended by those with increased sexual risk.

In Vivo Measurement of Drug Efficacy in Breast Cancer

DTIC Science & Technology

2016-10-01

analysis. At the clinical level, this study will result in pertinent data regarding several agents currently in clinical trials. At the basic science ...clinical level, this study will result in pertinent data regarding several agents currently in clinical trials. At the basic science level, we will...mg/kg BLZ-945 or encapsulated drug were tested in BALB/C mice expressing tumors in mammary fat pads, showing limited additional efficacy as seen

Implementation Considerations for Multisite Clinical Trials with Cognitive Neuroscience Tasks

PubMed Central

Keefe, Richard S. E.; Harvey, Philip D.

2008-01-01

Multisite clinical trials aimed at cognitive enhancement across various neuropsychiatric conditions have employed standard neuropsychological tests as outcome measures. While these tests have enjoyed wide clinical use and have proven reliable and predictive of functional disability, a number of implementation challenges have arisen when these tests are used in clinical trials. These issues are likely to be magnified in future studies when cognitive neuroscience (CN) procedures are explored in these trials, because in their current forms CN procedures are less standardized and more difficult to teach and monitor. For multisite trials, we anticipate that the most challenging issues will include assuring tester competence, monitoring tester performance, specific challenges with complex assessment methods, and having resources available for adequate monitoring of data quality. Suggestions for overcoming these implementation challenges are offered. PMID:18495645

Forensic Luminol Blood Test for Preventing Cross-contamination in Dentistry: An Evaluation of a Dental School Clinic.

PubMed

Bortoluzzi, Marcelo Carlos; Cadore, Peterson; Gallon, Andrea; Imanishi, Soraia Almeida Watanabe

2014-10-01

More than 200 different diseases may be transmitted from exposure to blood in the dental setting. The aim of this study is to identify possible faults in the crosscontamination chain control in a dental school clinic searching for traces of blood in the clinical contact surfaces (CCS) through forensic luminol blood test. Traces of invisible blood where randomly searched in CCS of one dental school clinic. Forty eight surfaces areas in the CCS were tested and the presence of invisible and remnant blood was identified in 28 (58.3%) items. We suggest that the luminol method is suitable for identifying contamination with invisible blood traces and this method may be a useful tool to prevent cross-contamination in the dental care setting.

[Development and effects of emotional intelligence program for undergraduate nursing students: mixed methods research].

PubMed

Lee, Oi Sun; Gu, Mee Ock

2014-12-01

This study was conducted to develop and test the effects of an emotional intelligence program for undergraduate nursing students. The study design was a mixed method research. Participants were 36 nursing students (intervention group: 17, control group: 19). The emotional intelligence program was provided for 4 weeks (8 sessions, 20 hours). Data were collected between August 6 and October 4, 2013. Quantitative data were analyzed using Chi-square, Fisher's exact test, t-test, repeated measure ANOVA, and paired t-test with SPSS/WIN 18.0. Qualitative data were analyzed using content analysis. Quantitative results showed that emotional intelligence, communication skills, resilience, stress coping strategy, and clinical competence were significantly better in the experimental group compared to the control group. According to the qualitative results, the nursing students experienced improvement in emotional intelligence, interpersonal relationships, and empowerment, as well as a reduction in clinical practice stress after participation in the emotional intelligence program. Study findings indicate that the emotional intelligence program for undergraduate nursing students is effective and can be recommended as an intervention for improving the clinical competence of undergraduate students in a nursing curriculum.

A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: study design, implementation, and baseline cohort characteristics.

PubMed

Koethe, John R; Westfall, Andrew O; Luhanga, Dora K; Clark, Gina M; Goldman, Jason D; Mulenga, Priscilla L; Cantrell, Ronald A; Chi, Benjamin H; Zulu, Isaac; Saag, Michael S; Stringer, Jeffrey S A

2010-03-12

The benefit of routine HIV-1 viral load (VL) monitoring of patients on antiretroviral therapy (ART) in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree). Dedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation) to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months. From December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites. A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings. Clinicaltrials.gov NCT00929604.

Relationship between antimicrobial susceptibility of clinical mastitis pathogens and treatment outcome in cows.

PubMed

Hoe, Fernanda G H; Ruegg, Pamela L

2005-11-01

To determine whether there was any association between results of in vitro antimicrobial susceptibility testing of pathogens isolated from cows with mild or moderate clinical mastitis and outcome of treatment. Observational study. 133 cows with mild or moderate mastitis in a single quarter. Cows were treated by means of intramammary infusion of pirlimycin (50 mg) in the affected quarter once daily for 2 days; additional intramammary treatments with the same product were administered if the milk continued to appear abnormal. Duration of treatment and days until clinical cure were recorded. Bacterial isolates were tested for antimicrobial susceptibility by means of a broth micro-dilution technique. Environmental streptococci, coliforms, and coagulase-negative Staphylococcus spp were the most commonly isolated pathogens. Duration of treatment and days until clinical cure were not significantly different for cows from which pathogens that were susceptible or resistant to pirlimycin were isolated. Bacteriologic cure rates 14 and 21 days after treatment were not significantly different for cows with mastitis caused by susceptible or resistant bacteria. Similar results were found when data only from cows with mastitis caused by gram-positive isolates were analyzed. In the present study, differences in clinical outcome for cows with mild or moderate mastitis that could be attributed to differences in results of in vitro susceptibility testing were not identified. The use of in vitro susceptibility testing to guide intramammary mastitis treatment cannot be recommended on the basis of results of this study.

[Myasthenia gravis in infancy. A report of 12 cases].

PubMed

Garófalo-Gómez, N; Sardiñas-Hernández, N L; Vargas-Díaz, J; Rojas-Massipe, E; Novoa-López, L

Myasthenia gravis (MG) shows specific clinical features in children. It is essential to know this and also the use of diagnostic techniques used in infancy and childhood for correct diagnosis. To analyze the clinical behaviour of this disorder and the use of complementary tests in the diagnosis of paediatric patients. We studied a group of 12 children diagnosed as having MG, who were admitted to the Instituto de Neurolog a y Neurocirug a de Ciudad de La Habana (Cuba) between March 1997 and June 2001. Data were obtained from the clinical histories regarding the clinical picture, anticholinesterase test, repetitive stimulation test (RST), simple fibre test (SFT), computerized axial tomography (CAT) of the mediastinum and the treatment given in each case. Juvenile myasthenia gravis (JMG) presented in 91% of the patients studied. The average age of onset of JMG was 7.45 years, with no difference in presentation in the two sexes. The extrinsic muscles of the eye were most affected and the form with generalized clinical involvement predominated at the time of admission. The RST was positive in four of the nine patients in whom it was done (44%) and the SFT was positive in the six cases in which it was done. No changes were found in the mediastinum on CAT scanning. Mestinon and prednisone were the most commonly used drugs. In our group JMG was the most frequent form seen. Neurophysiological studies were very useful diagnostic tools.

Earlier Detection of Hepatitis C Virus Infection Through Routine Hepatitis C Virus Antibody Screening of Human Immunodeficiency Virus-Positive Men Who Have Sex With Men Attending A Sexually Transmitted Infection Outpatient Clinic: A Longitudinal Study.

PubMed

van Rooijen, Martijn; Heijman, Titia; de Vrieze, Nynke; Urbanus, Anouk; Speksnijder, Arjen; van Leeuwen, Petra; de Vries, Henry; Prins, Maria

2016-09-01

In 2007, routine hepatitis C virus (HCV) antibody testing was introduced for men who have sex with men (MSM) with a human immunodeficiency virus (HIV)-positive or unknown status attending a Dutch sexually transmitted infection (STI) outpatient clinic. We evaluated whether this screening resulted in additional and earlier HCV diagnoses among MSM who also attend HIV clinics. At first STI consultation, HIV-positive MSM and MSM opting-out of HIV testing (HIV-status-unknown) were tested for HCV antibodies (anti-HCV). During follow-up consultations, only previously HCV-negative men were tested. Retrospectively, STI clinic and HIV clinic HCV diagnosis dates were compared. One hundred twelve (6.4%) of 1742 (95% confidence interval [CI], 5.3-7.6%) HIV-positive and 3 (0.7%) of 446 (95% CI, 0.2-2.0%) HIV-status-unknown MSM tested anti-HCV-positive at first consultation. During follow-up consultations, 32 HIV-positive (incidence HCV-positive: 2.35/100 person years (PY) (95% CI, 1.66-3.33)) and 0 (1-sided, 97.5% CI, 0.0-3.76) HIV-status-unknown MSM became anti-HCV-positive. Four (11.8%) of 34 HIV-positive MSM notified by their sexual partner of HCV tested anti-HCV-positive.Of 163 HIV-positive MSM with HCV antibodies, 78 reported a history of HCV. HCV diagnosis data at the HIV clinic was requested for the remaining 85 MSM and available for 54 MSM. Of these 54 MSM, 28 (51.9%) had their first HCV diagnosis at the STI clinic, of whom 7 concurrently with HIV. At their next scheduled HIV clinic consultation, 3 HCV cases probably would have been missed. The introduction of routine anti-HCV testing at the STI outpatient clinic resulted in additional and earlier HCV detection among HIV-positive MSM. Testing should be continued among HIV-positive MSM, at least for those not (yet) under the care of an HIV clinic and those notified of HCV by their sexual partner.

Human papillomavirus testing for triage of women with cytologic evidence of low-grade squamous intraepithelial lesions: baseline data from a randomized trial. The Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesions Triage Study (ALTS) Group.

PubMed

2000-03-01

Human papillomavirus (HPV) infections appear to be central to the development of cervical cancer. This study addresses the question of whether testing women who have low-grade squamous intraepithelial lesions (LSILs) of the uterine cervix for HPV DNA is useful as a triage strategy. Four clinical centers in different areas of the United States participated in a randomized clinical trial of the use of HPV DNA testing in women with cytologic evidence of atypical squamous cells of undetermined significance (ASCUS) or LSIL. The study sample in this article consists only of women who had LSIL at enrollment. Within 6 months of an LSIL diagnosis (based on a Pap smear read by a community-based cytopathologist), women who were 18 years of age or older completed a standardized questionnaire and underwent a pelvic examination that included collection of cervical specimens for HPV DNA testing by Hybrid Capture II (HCII)(R) assay. Among the 642 women referred with LSIL who had analyzable test results, the mean chronologic age and age at first coitus were similar among the four clinical centers, despite the centers' ethnic and geographic diversity. Overall, HPV DNA was detected in cervical samples from 532 (82.9%) of the 642 women (95% confidence interval = 79.7%-85.7%). This high frequency of HPV positivity was confirmed by polymerase chain reaction (PCR) assays in a subset of 210 paired specimens tested by HCII and PCR (81.4% were positive by both methods). Because a very high percentage of women with an LSIL diagnosis from Pap smears are positive for HPV DNA by HCII testing, there is limited potential for this assay to direct decisions about the clinical management of women with LSIL. The role of HPV testing in the management of women with ASCUS is still under study.

"Think aloud" and "Near live" usability testing of two complex clinical decision support tools.

PubMed

Richardson, Safiya; Mishuris, Rebecca; O'Connell, Alexander; Feldstein, David; Hess, Rachel; Smith, Paul; McCullagh, Lauren; McGinn, Thomas; Mann, Devin

2017-10-01

Low provider adoption continues to be a significant barrier to realizing the potential of clinical decision support. "Think Aloud" and "Near Live" usability testing were conducted on two clinical decision support tools. Each was composed of an alert, a clinical prediction rule which estimated risk of either group A Streptococcus pharyngitis or pneumonia and an automatic order set based on risk. The objective of this study was to further understanding of the facilitators of usability and to evaluate the types of additional information gained from proceeding to "Near Live" testing after completing "Think Aloud". This was a qualitative observational study conducted at a large academic health care system with 12 primary care providers. During "Think Aloud" testing, participants were provided with written clinical scenarios and asked to verbalize their thought process while interacting with the tool. During "Near Live" testing participants interacted with a mock patient. Morae usability software was used to record full screen capture and audio during every session. Participant comments were placed into coding categories and analyzed for generalizable themes. Themes were compared across usability methods. "Think Aloud" and "Near Live" usability testing generated similar themes under the coding categories visibility, workflow, content, understand-ability and navigation. However, they generated significantly different themes under the coding categories usability, practical usefulness and medical usefulness. During both types of testing participants found the tool easier to use when important text was distinct in its appearance, alerts were passive and appropriately timed, content was up to date, language was clear and simple, and each component of the tool included obvious indicators of next steps. Participant comments reflected higher expectations for usability and usefulness during "Near Live" testing. For example, visit aids, such as automatically generated order sets, were felt to be less useful during "Near-Live" testing because they would not be all inclusive for the visit. These complementary types of usability testing generated unique and generalizable insights. Feedback during "Think Aloud" testing primarily helped to improve the tools' ease of use. The additional feedback from "Near Live" testing, which mimics a real clinical encounter, was helpful for eliciting key barriers and facilitators to provider workflow and adoption. Copyright © 2017 Elsevier B.V. All rights reserved.

Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial).

PubMed

Labhardt, Niklaus Daniel; Ringera, Isaac; Lejone, Thabo Ishmael; Masethothi, Phofu; Thaanyane, T'sepang; Kamele, Mashaete; Gupta, Ravi Shankar; Thin, Kyaw; Cerutti, Bernard; Klimkait, Thomas; Fritz, Christiane; Glass, Tracy Renée

2016-04-14

Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART) in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation. This two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test). The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms. This trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow-up visits at the clinic could be a pragmatic approach to improve the care cascade in similar settings. NCT02692027 , registered February 21, 2016.

The Brief Fear of Negative Evaluation Scale (BFNE): translation and validation study of the Iranian version.

PubMed

Tavoli, Azadeh; Melyani, Mahdiyeh; Bakhtiari, Maryam; Ghaedi, Gholam Hossein; Montazeri, Ali

2009-07-09

The Brief Fear of Negative Evaluation Scale (BFNE) is a commonly used instrument to measure social anxiety. This study aimed to translate and to test the reliability and validity of the BFNE in Iran. The English language version of the BFNE was translated into Persian (Iranian language) and was used in this study. The questionnaire was administered to a consecutive sample of 235 students with (n = 33, clinical group) and without social phobia (n = 202, non-clinical group). In addition to the BFNE, two standard instruments were used to measure social phobia severity: the Social Phobia Inventory (SPIN), and the Social Interaction Anxiety Scale (SIAS). All participants completed a brief background information questionnaire, the SPIN, the SIAS and the BFNE scales. Statistical analysis was performed to test the reliability and validity of the BFNE. In all 235 students were studied (111 male and 124 female). The mean age for non-clinical group was 22.2 (SD = 2.1) years and for clinical sample it was 22.4 (SD = 1.8) years. Cronbach's alpha coefficient (to test reliability) was acceptable for both non-clinical and clinical samples (alpha = 0.90 and 0.82 respectively). In addition, 3-week test-retest reliability was performed in non-clinical sample and the intraclass correlation coefficient (ICC) was quite high (ICC = 0.71). Validity as performed using convergent and discriminant validity showed satisfactory results. The questionnaire correlated well with established measures of social phobia such as the SPIN (r = 0.43, p < 0.001) and the SIAS (r = 0.54, p < 0.001). Also the BFNE discriminated well between men and women with and without social phobia in the expected direction. Factor analysis supported a two-factor solution corresponding to positive and reverse-worded items. This validation study of the Iranian version of BFNE proved that it is an acceptable, reliable and valid measure of social phobia. However, since the scale showed a two-factor structure and this does not confirm to the theoretical basis for the BFNE, thus we suggest the use of the BFNE-II when it becomes available in Iran. The validation study of the BFNE-II is in progress.

Ubiquitous testing using tablets: its impact on medical student perceptions of and engagement in learning.

PubMed

Kim, Kyong-Jee; Hwang, Jee-Young

2016-03-01

Ubiquitous testing has the potential to affect medical education by enhancing the authenticity of the assessment using multimedia items. This study explored medical students' experience with ubiquitous testing and its impact on student learning. A cohort (n=48) of third-year students at a medical school in South Korea participated in this study. The students were divided into two groups and were given different versions of 10 content-matched items: one in text version (the text group) and the other in multimedia version (the multimedia group). Multimedia items were delivered using tablets. Item response analyses were performed to compare item characteristics between the two versions. Additionally, focus group interviews were held to investigate the students' experiences of ubiquitous testing. The mean test score was significantly higher in the text group. Item difficulty and discrimination did not differ between text and multimedia items. The participants generally showed positive responses on ubiquitous testing. Still, they felt that the lectures that they had taken in preclinical years did not prepare them enough for this type of assessment and clinical encounters during clerkships were more helpful. To be better prepared, the participants felt that they needed to engage more actively in learning in clinical clerkships and have more access to multimedia learning resources. Ubiquitous testing can positively affect student learning by reinforcing the importance of being able to understand and apply knowledge in clinical contexts, which drives students to engage more actively in learning in clinical settings.

Limited diagnostic accuracy of magnetic resonance imaging and clinical tests for detecting partial-thickness tears of the rotator cuff.

PubMed

Brockmeyer, Matthias; Schmitt, Cornelia; Haupert, Alexander; Kohn, Dieter; Lorbach, Olaf

2017-12-01

The reliable diagnosis of partial-thickness tears of the rotator cuff is still elusive in clinical practise. Therefore, the purpose of the study was to determine the diagnostic accuracy of MR imaging and clinical tests for detecting partial-thickness tears of the rotator cuff as well as the combination of these parameters. 334 consecutive shoulder arthroscopies for rotator cuff pathologies performed during the time period between 2010 and 2012 were analyzed retrospectively for the findings of common clinical signs for rotator cuff lesions and preoperative MR imaging. These were compared with the intraoperative arthroscopic findings as "gold standard". The reports of the MR imaging were evaluated with regard to the integrity of the rotator cuff. The Ellman Classification was used to define partial-thickness tears of the rotator cuff in accordance with the arthroscopic findings. Descriptive statistics, sensitivity, specificity, positive and negative predictive value were calculated. MR imaging showed 80 partial-thickness and 70 full-thickness tears of the rotator cuff. The arthroscopic examination confirmed 64 partial-thickness tears of which 52 needed debridement or refixation of the rotator cuff. Sensitivity for MR imaging to identify partial-thickness tears was 51.6%, specificity 77.2%, positive predictive value 41.3% and negative predictive value 83.7%. For the Jobe-test, sensitivity was 64.1%, specificity 43.2%, positive predictive value 25.9% and negative predictive value 79.5%. Sensitivity for the Impingement-sign was 76.7%, specificity 46.6%, positive predictive value 30.8% and negative predictive value 86.5%. For the combination of MR imaging, Jobe-test and Impingement-sign sensitivity was 46.9%, specificity 85.4%, positive predictive value 50% and negative predictive value 83.8%. The diagnostic accuracy of MR imaging and clinical tests (Jobe-test and Impingement-sign) alone is limited for detecting partial-thickness tears of the rotator cuff. Additionally, the combination of MR imaging and clinical tests does not improve diagnostic accuracy. Level II, Diagnostic study.

HIV counseling and testing practices among clients presenting at a market HIV clinic in Kampala, Uganda: a cross-sectional study.

PubMed

Matovu, Joseph Kb; Bukuluki, Paul W; Mafigiri, David K; Mudondo, Harriet

2017-09-01

Uptake of HIV counseling and testing (HCT) among informal sector workers is not well documented. To assess HCT practices among clients presenting for HIV services at a market HIV clinic in Kampala, Uganda. Between August 1 and September 15, 2009, clients presenting for HIV services at a market HIV clinic were invited to participate in the study. Socio-demographic and HCT data were collected from consenting adults aged 16+ years. Descriptive statistics were performed using STATA version 14.1. Of 224 individuals who consented to the interview, n=139 62 % were market vendors while n=85 38 % were engaged in other market-related activities. Majority of the respondents, n=165, 73.7 %, had ever tested for HIV; of these, n=148,89.7 % had ever tested for 2+ times. The main reasons for repeat testing were the need to confirm previous HIV test results, n=126, 85.1% and the belief that the previous HIV test results were false, n=35, 23.6 %. Uptake of couples' HCT was low, n=63, 38.2 %, despite the fact that n=200, 89 % had ever heard of couples' HCT. These findings indicate high rates of repeat testing but low rates of couples' HCT uptake in this population.

The British Association for Sexual Health and HIV 2016 UK national audit and survey of clinic policies in relation to risk assessment, HIV testing and follow-up.

PubMed

Bhaduri, S; Curtis, H; McClean, H; Sullivan, A K

2018-01-01

This national audit of 142 clinics demonstrated that the majority of clinics surveyed had policies and agreed clinical practice for alcohol and recreational drug enquiry, as well as documentation of HIV test refusal, although this was not the case in 24% of clinics as regards alcohol usage, 21% of clinics as regards recreational drugs use and 43% of clinics as regards chemsex usage. Regarding management of HIV test refusal, there was no policy or agreed practice in 13% of clinics with respect to men having sex with men (MSM) attenders, and in 18% of clinics for heterosexual attenders. Seventy percent of clinics had HIV point of care tests (POCT) available. Recommendations include: all clinics should have a policy of routine enquiry about alcohol, recreational drugs and chemsex, all clinics should record reasons for HIV test refusal and all clinics should provide testing alternatives to improve uptake, e.g. point of care testing or home sampling.

Angiogenic factors combined with clinical risk factors to predict preterm pre-eclampsia in nulliparous women: a predictive test accuracy study.

PubMed

Myers, J E; Kenny, L C; McCowan, L M E; Chan, E H Y; Dekker, G A; Poston, L; Simpson, N A B; North, R A

2013-09-01

To assess the performance of clinical risk factors, uterine artery Doppler and angiogenic markers to predict preterm pre-eclampsia in nulliparous women. Predictive test accuracy study. Prospective multicentre cohort study Screening for Pregnancy Endpoints (SCOPE). Low-risk nulliparous women with a singleton pregnancy were recruited. Clinical risk factor data were obtained and plasma placental growth factor (PlGF), soluble endoglin and soluble fms-like tyrosine kinase-1 (sFlt-1) were measured at 14-16 weeks of gestation. Prediction models were developed using multivariable stepwise logistic regression. Preterm pre-eclampsia (delivered before 37(+0)  weeks of gestation). Of the 3529 women recruited, 187 (5.3%) developed pre-eclampsia of whom 47 (1.3%) delivered preterm. Controls (n = 188) were randomly selected from women without preterm pre-eclampsia and included women who developed other pregnancy complications. An area under a receiver operating characteristic curve (AUC) of 0.76 (95% CI 0.67-0.84) was observed using previously reported clinical risk variables. The AUC improved following the addition of PlGF measured at 14-16 weeks (0.84; 95% CI 0.77-0.91), but no further improvement was observed with the addition of uterine artery Doppler or the other angiogenic markers. A sensitivity of 45% (95% CI 0.31-0.59) (5% false-positive rate) and post-test probability of 11% (95% CI 9-13) were observed using clinical risk variables and PlGF measurement. Addition of plasma PlGF at 14-16 weeks of gestation to clinical risk assessment improved the identification of nulliparous women at increased risk of developing preterm pre-eclampsia, but the performance is not sufficient to warrant introduction as a clinical screening test. These findings are marker dependent, not assay dependent; additional markers are needed to achieve clinical utility. © 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.

Reliability Measure of a Clinical Test: Appreciation of Music in Cochlear Implantees (AMICI)

PubMed Central

Cheng, Min-Yu; Spitzer, Jaclyn B.; Shafiro, Valeriy; Sheft, Stanley; Mancuso, Dean

2014-01-01

Purpose The goals of this study were (1) to investigate the reliability of a clinical music perception test, Appreciation of Music in Cochlear Implantees (AMICI), and (2) examine associations between the perception of music and speech. AMICI was developed as a clinical instrument for assessing music perception in persons with cochlear implants (CIs). The test consists of four subtests: (1) music versus environmental noise discrimination, (2) musical instrument identification (closed-set), (3) musical style identification (closed-set), and (4) identification of musical pieces (open-set). To be clinically useful, it is crucial for AMICI to demonstrate high test-retest reliability, so that CI users can be assessed and retested after changes in maps or programming strategies. Research Design Thirteen CI subjects were tested with AMICI for the initial visit and retested again 10–14 days later. Two speech perception tests (consonant-nucleus-consonant [CNC] and Bamford-Kowal-Bench Speech-in-Noise [BKB-SIN]) were also administered. Data Analysis Test-retest reliability and equivalence of the test’s three forms were analyzed using paired t-tests and correlation coefficients, respectively. Correlation analysis was also conducted between results from the music and speech perception tests. Results Results showed no significant difference between test and retest (p > 0.05) with adequate power (0.9) as well as high correlations between the three forms (Forms A and B, r = 0.91; Forms A and C, r = 0.91; Forms B and C, r = 0.95). Correlation analysis showed high correlation between AMICI and BKB-SIN (r = −0.71), and moderate correlation between AMICI and CNC (r = 0.4). Conclusions The study showed AMICI is highly reliable for assessing musical perception in CI users. PMID:24384082

Verification of an Automated, Digital Dispensing Platform for At-Will Broth Microdilution-Based Antimicrobial Susceptibility Testing.

PubMed

Smith, Kenneth P; Kirby, James E

2016-09-01

With rapid emergence of multidrug-resistant bacteria, there is often a need to perform susceptibility testing for less commonly used or newer antimicrobial agents. Such testing can often be performed only by using labor-intensive, manual dilution methods and lies outside the capacity of most clinical labs, necessitating reference laboratory testing and thereby delaying the availability of susceptibility data. To address the compelling clinical need for microbiology laboratories to perform such testing in-house, we explored a novel, automated, at-will broth microdilution-based susceptibility testing platform. Specifically, we used the modified inkjet printer technology in the HP D300 digital dispensing system to dispense, directly from stock solutions into a 384-well plate, the 2-fold serial dilution series required for broth microdilution testing. This technology was combined with automated absorbance readings and data analysis to determine MICs. Performance was verified by testing members of the Enterobacteriaceae for susceptibility to ampicillin, cefazolin, ciprofloxacin, colistin, gentamicin, meropenem, and tetracycline in comparison to the results obtained with a broth microdilution reference standard. In precision studies, essential and categorical agreement levels were 96.8% and 98.3%, respectively. Furthermore, significantly fewer D300-based measurements were outside ±1 dilution from the modal MIC, suggesting enhanced reproducibility. In accuracy studies performed using a panel of 80 curated clinical isolates, rates of essential and categorical agreement and very major, major, and minor errors were 94%, 96.6%, 0%, 0%, and 3.4%, respectively. Based on these promising initial results, it is anticipated that the D300-based methodology will enable hospital-based clinical microbiology laboratories to perform at-will broth microdilution testing of antimicrobials and to address a critical testing gap. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Impact of the rapid antigen detection test in diagnosis and treatment of acute pharyngotonsillitis in a pediatric emergency room.

PubMed

Cardoso, Débora Morais; Gilio, Alfredo Elias; Hsin, Shieh Huei; Machado, Beatriz Marcondes; de Paulis, Milena; Lotufo, João Paulo B; Martinez, Marina Baquerizo; Grisi, Sandra Josefina E

2013-01-01

To evaluate the impact of the routine use of rapid antigen detection test in the diagnosis and treatment of acute pharyngotonsillitis in children. This is a prospective and observational study, with a protocol compliance design established at the Emergency Unit of the University Hospital of Universidade de São Paulo for the care of children and adolescents diagnosed with acute pharyngitis. 650 children and adolescents were enrolled. Based on clinical findings, antibiotics would be prescribed for 389 patients (59.8%); using the rapid antigen detection test, they were prescribed for 286 patients (44.0%). Among the 261 children who would not have received antibiotics based on the clinical evaluation, 111 (42.5%) had positive rapid antigen detection test. The diagnosis based only on clinical evaluation showed 61.1% sensitivity, 47.7% specificity, 44.9% positive predictive value, and 57.5% negative predictive value. The clinical diagnosis of streptococcal pharyngotonsillitis had low sensitivity and specificity. The routine use of rapid antigen detection test led to the reduction of antibiotic use and the identification of a risk group for complications of streptococcal infection, since 42.5% positive rapid antigen detection test patients would not have received antibiotics based only on clinical diagnosis.

Diagnosis of Acute Gout: A Clinical Practice Guideline From the American College of Physicians.

PubMed

Qaseem, Amir; McLean, Robert M; Starkey, Melissa; Forciea, Mary Ann

2017-01-03

The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the diagnosis of gout. This guideline is based on a systematic review of published studies on gout diagnosis, identified using several databases, from database inception to February 2016. Evaluated outcomes included the accuracy of the test results; intermediate outcomes (results of laboratory and radiographic tests, such as serum urate and synovial fluid crystal analysis and radiographic or ultrasonography changes); clinical decision making (additional testing and pharmacologic or dietary management); short-term clinical (patient-centered) outcomes, such as pain and joint swelling and tenderness; and adverse effects of the tests. This guideline grades the evidence and recommendations by using the ACP grading system, which is based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. The target audience for this guideline includes all clinicians, and the target patient population includes adults with joint inflammation suspected to be gout. ACP recommends that clinicians use synovial fluid analysis when clinical judgment indicates that diagnostic testing is necessary in patients with possible acute gout. (Grade: weak recommendation, low-quality evidence).

Temporal unfolding of declining episodic memory on the Free and Cued Selective Reminding Test in the predementia phase of Alzheimer's disease: Implications for clinical trials.

PubMed

Grober, Ellen; Veroff, Amy E; Lipton, Richard B

2018-01-01

Free and Cued Selective Reminding Test (FCSRT) performance identifies patients with preclinical disease at elevated risk for developing Alzheimer's dementia, predicting diagnosis better than other memory tests. Based on literature mapping FCSRT performance to clinical outcomes and biological markers, and on longitudinal preclinical data from the Baltimore Longitudinal Study of Aging, we developed the Stages of Objective Memory Impairment (SOMI) model. Five sequential stages of episodic memory decline are defined by Free Recall (FR) and Total Recall (TR) score ranges and years prior to dementia diagnosis. We sought to replicate the SOMI model using longitudinal assessments of 142 Einstein Aging Study participants who developed AD over 10 years. Time to diagnosis was at least seven years if FR was intact, at least four years if TR was intact, and two years if TR was impaired, consistent with SOMI model predictions. The SOMI identified incipient dementia with excellent sensitivity and specificity. The SOMI model provides an efficient approach for clinical trial cognitive screening in advance of more costly biomarker studies and ultimately in clinical practice, and provides a vocabulary for understanding AD biomarker patterns and for re-analysis of existing clinical trial data.

Sensitivity of mouse bioassay in clinical wound botulism.

PubMed

Wheeler, Charlotte; Inami, Gregory; Mohle-Boetani, Janet; Vugia, Duc

2009-06-15

California has an ongoing epidemic of wound botulism (WB) among injection drug users (IDUs). We retrospectively studied a cohort of patients with WB and determined the sensitivity of the mouse bioassay-the gold standard laboratory test for confirmation of botulism-in verifying WB. We defined a clinical case of WB as an acute, bilateral, descending, flaccid paralysis starting with 1 cranial nerve palsies in an IDU with no other explainable diagnosis. We calculated the sensitivity of the mouse bioassay as the proportion of clinical WB cases that had positive serum toxin test results by mouse bioassay. We compared serum toxin-positive with serum toxin-negative patients. Of 73 patients with WB, 50 tested serum toxin positive, yielding a sensitivity of 68%. Serum toxin-positive patients did not differ significantly from serum toxin-negative patients with respect to demographic characteristics or injection drug use practices or in days from patient symptom onset to collection of specimens for testing. Patients did not differ significantly by clinical characteristics, except that serum toxin-positive patients were more likely than serum toxin-negative patients to have required mechanical ventilation during their hospital courses (74% vs. 43%; P = .01). In this study, the mouse bioassay failed to detect botulinum toxin in the serum samples of nearly one-third of IDUs with characteristic WB. Such patients should be considered to have probable WB. Physicians should be aware of the test's limitations and base their final diagnosis of suspected WB on clinical criteria when the mouse bioassay produces negative results.

Clinical efficacy of dim light melatonin onset testing in diagnosing delayed sleep phase syndrome.

PubMed

Rahman, Shadab A; Kayumov, Leonid; Tchmoutina, Ekaterina A; Shapiro, Colin M

2009-05-01

Delayed Sleep Phase Syndrome (DSPS) arises from biological clock desynchrony and accounts for 10% of chronic insomnia patients. Currently DSPS is diagnosed based on sleep/wake cycle disruptions rather than examining the underlying biological clock alterations. The objective of the study was to determine the sensitivity and specificity of the Dim Light Melatonin Onset (DLMO) Test in diagnosing DSPS in a clinical setting. Fifty-six patients (mean age 28 years) symptomatic of DSPS participated in the study. Following an initial assessment of DSPS using sleep diaries, participants underwent two consecutive nights of polysomnography (PSG), with an imposed sleep period on the second night to demonstrate the delay in the timing of habitual sleep period and to thereby confirm DSPS. Circadian phase delays were also measured using melatonin secretion profiles, and the efficacy of diagnosing DSPS using DLMO was compared to using sleep diaries and PSG. Melatonin secretion was assayed for each individual by ELISA using saliva samples. Main outcome measures included the time of melatonin secretion onset, clinical sensitivity and specificity of the DLMO test. The time of melatonin secretion onset was significantly delayed in DSPS patients. Clinical sensitivity and specificity of the DLMO test in diagnosing DSPS were 90.3% and 84.0%, respectively. The DLMO test is an accurate tool for differentiating between sleep disorder patients with or without underlying circadian rhythm disruption. It is effective for phase typing DSPS patients in a clinical setting.

Degree of Vertical Integration Between the Undergraduate Program and Clinical Internship with Respect to Lumbopelvic Diagnostic and Therapeutic Procedures Taught at the Canadian Memorial Chiropractic College

PubMed Central

Vermet, Shannon; McGinnis, Karen; Boodham, Melissa; Gleberzon, Brian J.

2010-01-01

Purpose: The objective of this study was to determine to what extent the diagnostic and therapeutic procedures taught in the undergraduate program used for patients with lumbopelvic conditions are expected to be utilized by students during their clinical internship program at Canadian Memorial Chiropractic College or are being used by the clinical faculty. Methods: A confidential survey was distributed to clinical faculty at the college. It consisted of a list of diagnostic and therapeutic procedures used for lumbopelvic conditions taught at that college. Clinicians were asked to indicate the frequency with which they performed or they required students to perform each item. Results: Seventeen of 23 clinicians responded. The following procedures were most likely required to be performed by clinicians: posture; ranges of motion; lower limb sensory, motor, and reflex testing; and core orthopedic tests. The following were less likely to be required to be performed: Waddell testing, Schober's test, Gillet tests, and abdominal palpation. Students were expected to perform (or clinicians performed) most of the mobilization (in particular, iliocostal, iliotransverse, and iliofemoral) and spinal manipulative therapies (in particular, the procedures referred to as the lumbar roll, lumbar pull/hook, and upper sacroiliac) taught at the college. Conclusion: This study suggests that there was considerable, but not complete, vertical integration between the undergraduate and clinical education program at this college. PMID:20480014

"Testing-only" visits: an assessment of missed diagnoses in clients attending sexually transmitted disease clinics.

PubMed

Xu, Fujie; Stoner, Bradley P; Taylor, Stephanie N; Mena, Leandro; Martin, David H; Powell, Suzanne; Markowitz, Lauri E

2013-01-01

At sexually transmitted disease (STD) clinics, advances in testing technology coupled with increasing demands and diminishing resources have promoted the use of testing-only visits (clinic visits with testing for STDs but no full examination) to meet increasing demands for STD services. The aims of the present study were to estimate the prevalence of STD diagnoses that could become "missed diagnoses" if patients would use testing-only visits and to examine patient characteristics associated with these potential missed diagnoses. We conducted a self-administered survey of STD-related symptoms and sexual risk behaviors in patients seeking routine clinical care at 3 STD clinics. Medical charts were abstracted to estimate the prevalence of viral STDs, trichomoniasis, and other diagnoses from standard clinical services that could become missed diagnoses. Of 2582 patients included, the median age was 24 years and 50% were women. In women, overall, 3.2% were diagnosed as having a viral STD; 9.6%, trichomoniasis; and 41.0%, vulvovaginal candidiasis or symptomatic bacterial vaginosis. The prevalence of these potential missed diagnoses varied by patient characteristics, but in women who reported no symptoms, the prevalence of trichomoniasis was still 6.3%. In men, 19.3% received a diagnosis of urethritis but tested negative for both gonorrhea and chlamydia; this prevalence varied from 15.7% in those who reported no symptoms to 32.6% in those who reported malodor. A high proportion of STD clients received diagnoses from standard care visits that would be missed by testing-only visits. When patients, even those asymptomatic, use testing-only visits, missed diagnoses of STDs or related genital tract conditions can be substantial. The potential disadvantages of testing-only visits should be weighed against the advantages of such visits.

Clinical learning environment and supervision: experiences of Norwegian nursing students - a questionnaire survey.

PubMed

Skaalvik, Mari Wolff; Normann, Hans Ketil; Henriksen, Nils

2011-08-01

To measure nursing students' experiences and satisfaction with their clinical learning environments. The primary interest was to compare the results between students with respect to clinical practice in nursing homes and hospital wards. Clinical learning environments are important for the learning processes of nursing students and for preferences for future workplaces. Working with older people is the least preferred area of practice among nursing students in Norway. A cross-sectional design. A validated questionnaire was distributed to all nursing students from five non-randomly selected university colleges in Norway. A total of 511 nursing students completed a Norwegian version of the questionnaire, Clinical Learning Environment, Supervision and Nurse Teacher (CLES+T) evaluation scale in 2009. Data including descriptive statistics were analysed using the Statistical Program for the Social Sciences. Factor structure was analysed by principal component analysis. Differences across sub-groups were tested with chi-square tests and Mann-Whitney U test for categorical variables and t-tests for continuous variables. Ordinal logistic regression analysis of perceptions of the ward as a good learning environment was performed with supervisory relationships and institutional contexts as independent variables, controlling for age, sex and study year. The participating nursing students with clinical placements in nursing homes assessed their clinical learning environment significantly more negatively than those with hospital placements on nearby all sub-dimensions. The evidence found in this study indicates that measures should be taken to strengthen nursing homes as learning environments for nursing students. To recruit more graduated nurses to work in nursing homes, actions to improve the learning environment are needed. © 2011 Blackwell Publishing Ltd.

Predoctoral Dental Students' Perceptions of Dental Implant Training: Effect of Preclinical Simulation and Clinical Experience.

PubMed

Prasad, Soni; Bansal, Naveen

2017-04-01

The aims of this study were to assess 1) differences in perceptions of dental implant training between dental students who received didactic training alone (control group) and those who received didactic plus simulation training (test group); 2) differences in response between students with and without clinical experience in implant dentistry; and 3) the interaction effect of simulation training and clinical experience on students' satisfaction. A survey was distributed to the control group in 2014 and to the test group in 2015; both groups were at the same U.S. dental school. Data were collected on confidence levels with various implant restorative procedures along with overall satisfaction and number of implant restorations performed by each student. The response rate was 78.7% in the control group and 81.3% in the test group. In the control group, 85.7% of students reported being satisfied with implant training compared to 90.8% of students in the test group. The interaction effect of simulation training and clinical experience on overall student satisfaction was OR=1.5 at 95% CI: 0.8, 3.0. The students who had clinical experience with implant restorative procedures had significantly greater satisfaction than those who did not (OR=4.8, 95% CI: 2.1, 11.1, p<0.01). This study found that both the simulation and clinical experience affected these students' confidence and satisfaction levels with implant education: they were almost five times more satisfied with implant training when clinical experience in implant restorative procedures was a part of their implant education.

The relationship between nurses’ clinical competence and burnout in neonatal intensive care units

PubMed Central

Soroush, Fatemehzahra; Zargham-Boroujeni, Ali; Namnabati, Mahboobeh

2016-01-01

Background: Nurses’ clinical competency plays an important role in the care of preterm infants. On the other hand, burnout is one of the most important factors in reducing the nurses’ efficiency. With regard to the importance of the role of nurses, and the vulnerability of the infants, the purpose of this study was to investigate the relationship between nurses’ burnout and clinical competency in NICUs. Materials and Methods: The descriptive cross-sectional study was conducted with the participation of 86 nurses working in the NICUs of hospitals in Isfahan, Iran. Census sampling method was used in the NICUs of educational hospitals in 2014. Data were collected by a questionnaire including demographic characteristics, Patricia clinical competency, and Maslach burnout scales. Data were analyzed by the statistical tests of independent t-test and Pearson correlations test with the significance level of α < 0.05. Results: Six dimensions of clinical competency and three dimensions of nurses’ burnout were assessed at three levels (weak, moderate, and strong levels). Statistical tests showed that clinical competency was at a moderate level in all fields. Of the dimensions of nurses’ burnout, emotional exhaustion was moderate, depersonalization was weak, and personal performance was strong. The results showed that nurses’ burnout and clinical competency in the NICUs were at a moderate level and had a significant negative relationship (r = −0.322, P = 0.003). Conclusions: Results showed that burnout had a negative relationship with competency. Therefore, managers are suggested to improve nurses’ competency and diminish their job burnout through better and more applicable planning. PMID:27563328

Notification and counselling of hepatitis positive blood donors, their immediate emotional response, contact-testing and their follow-up: Study from a tertiary care hospital!

PubMed

Tiwari, Aseem K; Bhardwaj, Gunjan; Dara, Ravi C; Arora, Dinesh; Aggarwal, Geet; Bhargava, Richa; Madan, Kaushal

2018-04-13

Post-donation counselling informs donors of unusual test results. Timely notification and counselling regarding their Transfusion Transmitted Infection (TTI) status is necessary for early clinical intervention in the donor and reducing risk of transmission. We share our experience with respect to Hepatitis B (HBV) and Hepatitis C (HCV) positive donors who were counselled and followed-up for clinical outcome. It was prospective 2-year study in TTI positive blood donors. Confirmed positive HBV/ HCV donors were notified to attend the donor-clinic or to visit local hepatologist for further management. At donor clinic, donor's immediate emotional response was observed; donors were offered contact-testing, associated risk factors were noted, counselled, referred to hepatologist, treated and followed-up for clinical outcome. Of 481 donors (0.91%) confirmed positives, 351 were contacted telephonically; 280 promised to attend donor clinic and 71 were referred to their local hepatologist. 145 donors attended the donor clinic, eventually. Most common immediate emotional response noted were 'feeling of fear' (55.2%) and 'disbelief' (35.2%). Most common associated risk factor was history of medical treatment/ injections without knowledge of sterilisation. Five donors availed contact testing and four (spouses in all four cases) came out positive. Of 98 donors contacted post-counselling; 89 went to hepatologist. No medication was advised to seven donors (low viral load), 59 donors completed treatment course and 23 donors were undergoing treatment at time of follow-up. Nine donors opted for alternative treatment or "no treatment". Donor-clinic proved beneficial to substantial number of donors and their families. Copyright © 2018 Elsevier Ltd. All rights reserved.

Comparative testing of disinfectant efficacy on planktonic bacteria and bacterial biofilms using a new assay based on kinetic analysis of metabolic activity.

PubMed

Günther, F; Scherrer, M; Kaiser, S J; DeRosa, A; Mutters, N T

2017-03-01

The aim of our study was to develop a new reproducible method for disinfectant efficacy testing on bacterial biofilms and to evaluate the efficacy of different disinfectants against biofilms. Clinical multidrug-resistant strains were chosen as test isolates to ensure practical relevance. We compared the standard qualitative suspension assay for disinfectant testing, which does not take into account biofilm formation, to the new biofilm viability assay that uses kinetic analysis of metabolic activity in biofilms after disinfectant exposure to evaluate disinfectant efficacy. In addition, the efficacy of four standard disinfectants to clinical isolates was tested using both methods. All tested disinfectants were effective against test isolates when in planktonic state using the standard qualitative suspension assay, while disinfectants were only weakly effective against bacteria in biofilms. Disinfectant efficacy testing on planktonic organisms ignores biofilms and overestimates disinfectant susceptibility of bacteria. However, biofilm forming, e.g. on medical devices or hospital surfaces, is the natural state of bacterial living and needs to be considered in disinfectant testing. Although bacterial biofilms are the predominant manner of bacterial colonization, most standard procedures for antimicrobial susceptibility testing and efficacy testing of disinfectants are adapted for application to planktonic bacteria. To our knowledge, this is the first study to use a newly developed microplate-based biofilm test system that uses kinetic analysis of the metabolic activity in biofilms, after disinfectant exposure, to evaluate disinfectant efficacy. Our study shows that findings obtained from disinfectant efficacy testing on planktonic bacteria cannot be extrapolated to predict disinfectant efficacy on bacterial biofilms of clinically relevant multidrug-resistant organisms. © 2016 The Society for Applied Microbiology.

The prevalence of latex allergy in children seen in a university hospital allergy clinic.

PubMed

Novembre, E; Bernardini, R; Brizzi, I; Bertini, G; Mugnaini, L; Azzari, C; Vierucci, A

1997-01-01

Natural rubber latex allergy is responsible for a wide spectrum of clinical symptoms, ranging from rhinoconjunctivitis to severe anaphylaxis, in both adults and children. An association between allergy to latex and allergy to various fruits has been reported. This study investigated the prevalence and clinical significance of latex sensitization in children seen in a university hospital allergy clinic. A total of 453 consecutive children were screened in a 7-month period. A detailed clinical history with particular attention to the past surgical history and the eventual presence of latex- or food-induced allergic symptoms was obtained. Skin prick tests (SPT) for the more important inhalant allergens and foods were performed on all children. In patients with positive latex SPT, latex challenge and additional SPT for some fresh foods (avocado, pineapple, apricot, grape, banana, pear, apple, orange, almond, and chestnut) were also performed. RAST for the same food antigens, as well as patch test with latex and a standard battery of contact allergens, was also done. Of 326 atopic children, 10 (3%) presented positive skin test to latex, but only five (1.5%) also had a positive clinical history to latex exposure. Latex challenge was positive in 3/9 positive-latex-SPT children. None of the nonatopic children had positive skin test to latex or symptoms to latex exposure. A history of previous surgery was found in 5/10 positive-latex-SPT children, in 63/316 negative-latex-SPT atopic children (P < 0.05), and in 23/127 nonatopic children. RAST to latex was positive in 5/10 positive-latex-SPT children. Associated fruit-specific IgE (SPT and/or RAST) were found in all latex-symptomatic children and in 2/5 latex-asymptomatic children. Apple, kiwi, and chestnut were the most common SPT-positive foods. Only one patient with clinical allergy to latex and positive skin tests to fruits had a history of clinical symptoms after ingestion of kiwi and orange. The natural history of the positive-latex-SPT children without clinical reactions to latex exposure and the clinical significance of the association of latex and fruit sensitivity require further studies.

Unsuspected Leptospirosis Is a Cause of Acute Febrile Illness in Nicaragua

PubMed Central

Reller, Megan E.; Wunder, Elsio A.; Miles, Jeremy J.; Flom, Judith E.; Mayorga, Orlando; Woods, Christopher W.; Ko, Albert I.; Dumler, J. Stephen; Matute, Armando J.

2014-01-01

Background Epidemic severe leptospirosis was recognized in Nicaragua in 1995, but unrecognized epidemic and endemic disease remains unstudied. Methodology/Principal Findings To determine the burden of and risk factors associated with symptomatic leptospirosis in Nicaragua, we prospectively studied patients presenting with fever at a large teaching hospital. Epidemiologic and clinical features were systematically recorded, and paired sera tested by IgM-ELISA to identify patients with probable and possible acute leptospirosis. Microscopic Agglutination Test and PCR were used to confirm acute leptospirosis. Among 704 patients with paired sera tested by MAT, 44 had acute leptospirosis. Patients with acute leptospirosis were more likely to present during rainy months and to report rural residence and fresh water exposure. The sensitivity of clinical impression and acute-phase IgM detected by ELISA were poor. Conclusions/Significance Leptospirosis is a common (6.3%) but unrecognized cause of acute febrile illness in Nicaragua. Rapid point-of-care tests to support early diagnosis and treatment as well as tests to support population-based studies to delineate the epidemiology, incidence, and clinical spectrum of leptospirosis, both ideally pathogen-based, are needed. PMID:25058149

Testing homogeneity of proportion ratios for stratified correlated bilateral data in two-arm randomized clinical trials.

PubMed

Pei, Yanbo; Tian, Guo-Liang; Tang, Man-Lai

2014-11-10

Stratified data analysis is an important research topic in many biomedical studies and clinical trials. In this article, we develop five test statistics for testing the homogeneity of proportion ratios for stratified correlated bilateral binary data based on an equal correlation model assumption. Bootstrap procedures based on these test statistics are also considered. To evaluate the performance of these statistics and procedures, we conduct Monte Carlo simulations to study their empirical sizes and powers under various scenarios. Our results suggest that the procedure based on score statistic performs well generally and is highly recommended. When the sample size is large, procedures based on the commonly used weighted least square estimate and logarithmic transformation with Mantel-Haenszel estimate are recommended as they do not involve any computation of maximum likelihood estimates requiring iterative algorithms. We also derive approximate sample size formulas based on the recommended test procedures. Finally, we apply the proposed methods to analyze a multi-center randomized clinical trial for scleroderma patients. Copyright © 2014 John Wiley & Sons, Ltd.

Comparative In Vitro Efficacy of Doripenem and Imipenem Against Multi-Drug Resistant Pseudomonas aeruginosa.

PubMed

Wali, Nadia; Mirza, Irfan Ali

2016-04-01

To compare the in vitro efficacy of doripenem and imipenem against multi-drug resistant (MDR) Pseudomonas aeruginosa from various clinical specimens. Descriptive cross-sectional study. Department of Microbiology, Armed Forces Institute of Pathology, Rawalpindi, from November 2012 to November 2013. MDR Pseudomonas aeruginosa isolates from various clinical samples were included in the study. Susceptibility of Pseudomonas aeruginosa against doripenem and imipenem was performed by E-test strip and agar dilution methods. The results were interpreted as recommended by Clinical Laboratory Standard Institute (CLSI) guidelines. The maximum number of Pseudomonas aeruginosa were isolated from pure pus and pus swabs. In vitro efficacy of doripenem was found to be more effective as compared to imipenem against MDR Pseudomonas aeruginosa with both E-test strip and agar dilution methods. Overall, p-values of 0.014 and 0.037 were observed when susceptibility patterns of doripenem and imipenem were evaluated with E-test strip and agar dilution methods. In vitro efficacy of doripenem was found to be better against MDR Pseudomonas aeruginosaas compared to imipenem when tested by both E-test and agar dilution methods.

Development of guidance on the timeliness in response to acute kidney injury warning stage test results for adults in primary care: an appropriateness ratings evaluation

PubMed Central

Blakeman, Tom; Griffith, Kathryn; Lasserson, Dan; Lopez, Berenice; Tsang, Jung Y; Campbell, Stephen; Tomson, Charles

2016-01-01

Objectives Tackling the harm associated with acute kidney injury (AKI) is a global priority. In England, a national computerised AKI algorithm is being introduced across the National Health Service (NHS) to drive this change. The study sought to maximise its clinical utility and minimise the potential for burden on clinicians and patients in primary care. Design An appropriateness ratings evaluation using the RAND/UCLA Appropriateness Method. Setting Clinical scenarios were developed to test the timeliness in (1) communication of AKI warning stage test results from clinical pathology services to primary care, and (2) primary care clinician response to an AKI warning stage test result. Participants A 10-person panel was purposively sampled with representation from clinical biochemistry, acute and emergency medicine and general practice. General practitioners (GPs) represented typical practice in relation to rural and urban practice, out of hours care, GP commissioning and those interested in reducing the impact of medicalisation and ‘overdiagnosis’. Results There was agreement that delivery of AKI warning stage test results through interruptive methods of communication (ie, telephone) from laboratories to primary care was the appropriate next step for patients with an AKI warning stage 3 test result. In the context of acute illness, waiting up to 72 hours to respond to an AKI warning stage test result was deemed an inappropriate action in 62 out of the 65 (94.5%) cases. There was agreement that a clinician response was required within 6 hours, or less, in 39 out of 40 (97.5%) clinical cases relating AKI warning stage test results in the presence of moderate hyperkalaemia. Conclusions The study has informed national guidance to support a timely and calibrated response to AKI warning stage test results for adults in primary care. Further research is needed to support effective implementation, with a view to examine the effect on health outcomes and costs. PMID:27729353

Predictors of Academic Success for the National Board Dental Hygiene Examination and the Southern Regional Testing Agency Clinical Exam

ERIC Educational Resources Information Center

Efurd, Melissa G.

2012-01-01

The purpose for conducting this study was to investigate and describe the relationship between applicant criteria for a dental hygiene program and subsequent outcomes on credentialing exams: the National Board Dental Hygiene Exam and the Southern Regional Testing Agency clinical exam. Because admission criteria play a crucial role in applicant…

Incremental Criterion Validity of the WJ-III COG Clinical Clusters: Marginal Predictive Effects beyond the General Factor

ERIC Educational Resources Information Center

McGill, Ryan J.

2015-01-01

The current study examined the incremental validity of the clinical clusters from the Woodcock-Johnson III Tests of Cognitive Abilities (WJ-III COG) for predicting scores on the Woodcock-Johnson III Tests of Achievement (WJ-III ACH). All participants were children and adolescents (N = 4,722) drawn from the nationally representative WJ-III…

Lost in translation: neuropsychiatric drug development.

PubMed

Becker, Robert E; Greig, Nigel H

2010-12-08

Recent studies have identified troubling method and practice lapses in neuropsychiatric drug developments. These problems have resulted in errors that are of sufficient magnitude to invalidate clinical trial data and interpretations. We identify two potential sources for these difficulties: investigators selectively choosing scientific practices for demonstrations of efficacy in human-testing phases of drug development and investigators failing to anticipate the needs of practitioners who must optimize treatment for the individual patient. When clinical investigators neglect to use clinical trials as opportunities to test hypotheses of disease mechanisms in humans, the neuropsychiatric knowledge base loses both credibility and scope. When clinical investigators do not anticipate the need to translate discoveries into applications, the practitioner cannot provide optimal care for the patient. We conclude from this evidence that clinical trials, and other aspects of neuropsychiatric drug development, must adopt more practices from basic science and show greater responsiveness to conditions of clinical practice. We feel that these changes are necessary to overcome current threats to the validity and utility of studies of neurological and psychiatric drugs.

Clinical Tests Combined with Color Doppler Versus Color Doppler Alone in Identifying Incompetent Perforator Veins of the Lower Limb: A Prospective Analytical Study

PubMed Central

Vignesh, Narayan; Venkatachalam, J; Vijayakumar, Chellappa; Sudharsanan, Sundaramurthi

2018-01-01

Background The color Doppler, a better investigation to identify the perforators objectively has replaced the clinical examination for the same. However, this has led to a significant number of negative explorations and cosmetic disfigurement. Objective To compare the efficacy of the clinical tests combined with the color Doppler versus color Doppler alone to identify the perforator incompetence during the surgery for primary varicose veins of the lower limb. Methods This was a prospective analytical study, including 61 lower limb varicose vein patients who belonged to the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) class four-six, planned for the surgical treatment for perforator incompetence, excluding those requiring additional vascular or nonvascular procedure, recurrent varicose veins and those who had injection sclerotherapy prior to the surgery. The clinical tests, including Trendelenburg’s test, multiple tourniquet tests and, the Fegan’s tests were performed and incompetent perforators were marked on a template as ‘C’ to indicate the clinically positive perforator incompetence. The patients were then examined with the color Doppler ultrasound and the pathological incompetent perforators were marked as ‘D’. The surgical management of the perforator incompetence was done by stab ligation. The incision was made in the color Doppler ‘D’ marked sites as it has been the standard protocol. The number of incompetent perforators identified during the surgical exploration were categorized as ‘D’ positive or ’C’ and ‘D’ positive and were recorded in the specified proforma. Results It was found that the mean number of the perforator incompetence identified by the color Doppler alone was 8.2 whereas during the surgery, only a mean of six perforators was identified, leading to 20 unnecessary explorations per 10 patients (8.2 vs. 6; mean difference 2.229; P <0.001). The mean number of the perforator incompetence identified by the color Doppler combined with the clinical tests was 4.5 and during the surgery, a mean of four perforators was identified (4.5 vs. 4; mean difference 0.377; P <0.001). The color Doppler combined with the clinical examination lead to only four unnecessary explorations per 10 patients. Conclusion A combination of both the clinical tests and the color Doppler ultrasound has a higher accuracy in detecting perforator incompetence and can reduce the number of negative explorations by the rate of 16 unnecessary explorations per 10 patients. PMID:29531879

Clinical relevance is associated with allergen-specific wheal size in skin prick testing.

PubMed

Haahtela, T; Burbach, G J; Bachert, C; Bindslev-Jensen, C; Bonini, S; Bousquet, J; Bousquet-Rouanet, L; Bousquet, P J; Bresciani, M; Bruno, A; Canonica, G W; Darsow, U; Demoly, P; Durham, S R; Fokkens, W J; Giavi, S; Gjomarkaj, M; Gramiccioni, C; Kowalski, M L; Losonczy, G; Orosz, M; Papadopoulos, N G; Stingl, G; Todo-Bom, A; von Mutius, E; Köhli, A; Wöhrl, S; Järvenpää, S; Kautiainen, H; Petman, L; Selroos, O; Zuberbier, T; Heinzerling, L M

2014-03-01

Within a large prospective study, the Global Asthma and Allergy European Network (GA(2) LEN) has collected skin prick test (SPT) data throughout Europe to make recommendations for SPT in clinical settings. To improve clinical interpretation of SPT results for inhalant allergens by providing quantitative decision points. The GA(2) LEN SPT study with 3068 valid data sets was used to investigate the relationship between SPT results and patient-reported clinical relevance for each of the 18 inhalant allergens as well as SPT wheal size and physician-diagnosed allergy (rhinitis, asthma, atopic dermatitis, food allergy). The effects of age, gender, and geographical area on SPT results were assessed. For each allergen, the wheal size in mm with an 80% positive predictive value (PPV) for being clinically relevant was calculated. Depending on the allergen, from 40% (blatella) to 87-89% (grass, mites) of the positive SPT reactions (wheal size ≥ 3 mm) were associated with patient-reported clinical symptoms when exposed to the respective allergen. The risk of allergic symptoms increased significantly with larger wheal sizes for 17 of the 18 allergens tested. Children with positive SPT reactions had a smaller risk of sensitizations being clinically relevant compared with adults. The 80% PPV varied from 3 to 10 mm depending on the allergen. These 'reading keys' for 18 inhalant allergens can help interpret SPT results with respect to their clinical significance. A SPT form with the standard allergens including mm decision points for each allergen is offered for clinical use. © 2013 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.

Diagnostic accuracy of clinical tests of the hip: a systematic review with meta-analysis.

PubMed

Reiman, Michael P; Goode, Adam P; Hegedus, Eric J; Cook, Chad E; Wright, Alexis A

2013-09-01

Hip Physical Examination (HPE) tests have long been used to diagnose a myriad of intra-and extra-articular pathologies of the hip joint. Useful clinical utility is necessary to support diagnostic imaging and subsequent surgical decision making. Summarise and evaluate the current research and utility on the diagnostic accuracy of HPE tests for the hip joint germane to sports related injuries and pathology. A computer-assisted literature search of MEDLINE, CINHAL and EMBASE databases (January 1966 to January 2012) using keywords related to diagnostic accuracy of the hip joint. This systematic review with meta-analysis utilised the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for the search and reporting phases of the study. Der-Simonian and Laird random effects models were used to summarise sensitivities (SN), specificities (SP), likelihood ratios and diagnostic OR. The employed search strategy revealed 25 potential articles, with 10 demonstrating high quality. Fourteen articles qualified for meta-analysis. The meta-analysis demonstrated that most tests possess weak diagnostic properties with the exception of the patellar-pubic percussion test, which had excellent pooled SN 95 (95% CI 92 to 97%) and good specificity 86 (95% CI 78 to 92%). Several studies have investigated pathology in the hip. Few of the current studies are of substantial quality to dictate clinical decision-making. Currently, only the patellar-pubic percussion test is supported by the data as a stand-alone HPE test. Further studies involving high quality designs are needed to fully assess the value of HPE tests for patients with intra- and extra-articular hip dysfunction.

The clinical diagnostic reasoning process determining the use of endoscopy in diagnosing peptic ulcer disease.

PubMed

Gul, Naheed; Quadri, Mujtaba

2011-09-01

To evaluate the clinical diagnostic reasoning process as a tool to decrease the number of unnecessary endoscopies for diagnosing peptic ulcer disease. tudy Cross-sectional KAP study. Shifa College of Medicine, Islamabad, from April to August 2010. Two hundred doctors were assessed with three common clinical scenarios of low, intermediate and high pre-test probability for peptic ulcer disease using a questionnaire. The differences between the reference estimates and the respondents' estimates of pre-test and post test probability were used for assessing the ability of estimating the pretest probability and the post test probability of the disease. Doctors were also enquired about the cost-effectiveness and safety of endoscopy. Consecutive sampling technique was used and the data was analyzed using SPSS version 16. In the low pre-test probability settings, overestimation of the disease probability suggested the doctors' inability to rule out the disease. The post test probabilities were similarly overestimated. In intermediate pre-test probability settings, both over and under estimation of probabilities were noticed. In high pre-test probability setting, there was no significant difference in the reference and the responders' intuitive estimates of post test probability. Doctors were more likely to consider ordering the test as the disease probability increased. Most respondents were of the opinion that endoscopy is not a cost-effective procedure and may be associated with a potential harm. Improvement is needed in doctors' diagnostic ability by more emphasis on clinical decision-making and application of bayesian probabilistic thinking to real clinical situations.

Integrating genomics into clinical oncology: ethical and social challenges from proponents of personalized medicine.

PubMed

McGowan, Michelle L; Settersten, Richard A; Juengst, Eric T; Fishman, Jennifer R

2014-02-01

The use of molecular tools to individualize health care, predict appropriate therapies, and prevent adverse health outcomes has gained significant traction in the field of oncology under the banner of "personalized medicine" (PM). Enthusiasm for PM in oncology has been fueled by success stories of targeted treatments for a variety of cancers based on their molecular profiles. Though these are clear indications of optimism for PM, little is known about the ethical and social implications of personalized approaches in clinical oncology. The objective of this study is to assess how a range of stakeholders engaged in promoting, monitoring, and providing PM understand the challenges of integrating genomic testing and targeted therapies into clinical oncology. The study involved the analysis of in-depth interviews with 117 stakeholders whose experiences and perspectives on PM span a wide variety of institutional and professional settings. Despite their considerable enthusiasm for this shift, promoters, monitors, and providers of PM identified 4 domains that provoke heightened ethical and social concerns: (1) informed consent for cancer genomic testing, (2) privacy, confidentiality, and disclosure of genomic test results, (3) access to genomic testing and targeted therapies in oncology, and (4) the costs of scaling up pharmacogenomic testing and targeted cancer therapies. These specific concerns are not unique to oncology, or even genomics. However, those most invested in the success of PM view oncologists' responses to these challenges as precedent setting because oncology is farther along the path of clinical integration of genomic technologies than other fields of medicine. This study illustrates that the rapid emergence of PM approaches in clinical oncology provides a crucial lens for identifying and managing potential frictions and pitfalls that emerge as health care paradigms shift in these directions. © 2014 Published by Elsevier Inc.

Clinical assessment of effusion in knee osteoarthritis—A systematic review

PubMed Central

Maricar, Nasimah; Callaghan, Michael J.; Parkes, Matthew J.; Felson, David T.; O׳Neill, Terence W.

2016-01-01

Objective The aim of this systematic review was to determine the validity and inter- and intra-observer reliability of the assessment of knee joint effusion in osteoarthritis (OA) of the knee. Methods MEDLINE, Web of Knowledge, CINAHL, EMBASE, and AMED were searched from their inception to February 2015. Articles were included according to a priori defined criteria: samples containing participants with knee OA; prospective evaluation of clinical tests and assessments of knee effusion that included reliability, sensitivity, and specificity of these tests. Results A total of 10 publications were reviewed. Eight of these considered reliability and four on validity of clinical assessments against ultrasound effusion. It was not possible to undertake a meta-analysis of reliability or validity because of differences in study designs and the clinical tests. Intra-observer kappa agreement for visible swelling ranged from 0.37 (suprapatellar) to 1.0 (prepatellar); for bulge sign 0.47 and balloon sign 0.37. Inter-observer kappa agreement for visible swelling ranged from −0.02 (prepatellar) to 0.65 (infrapatellar), the balloon sign −0.11 to 0.82, patellar tap −0.02 to 0.75 and bulge sign kappa −0.04 to 0.14 or reliability coefficient 0.97. Reliability and diagnostic accuracy tended to be better in experienced observers. Very few data looked at performance of individual clinical tests with sensitivity ranging 18.2–85.7% and specificity 35.3–93.3%, both higher with larger effusions. Conclusion The majority of unstandardized clinical tests to assess joint effusion in knee OA had relatively low intra- and inter-observer reliability. There is some evidence experience improved reliability and diagnostic accuracy of tests. Currently there is insufficient evidence to recommend any particular test in clinical practice. PMID:26581486

Clinical assessment of effusion in knee osteoarthritis-A systematic review.

PubMed

Maricar, Nasimah; Callaghan, Michael J; Parkes, Matthew J; Felson, David T; O'Neill, Terence W

2016-04-01

The aim of this systematic review was to determine the validity and inter- and intra-observer reliability of the assessment of knee joint effusion in osteoarthritis (OA) of the knee. MEDLINE, Web of Knowledge, CINAHL, EMBASE, and AMED were searched from their inception to February 2015. Articles were included according to a priori defined criteria: samples containing participants with knee OA; prospective evaluation of clinical tests and assessments of knee effusion that included reliability, sensitivity, and specificity of these tests. A total of 10 publications were reviewed. Eight of these considered reliability and four on validity of clinical assessments against ultrasound effusion. It was not possible to undertake a meta-analysis of reliability or validity because of differences in study designs and the clinical tests. Intra-observer kappa agreement for visible swelling ranged from 0.37 (suprapatellar) to 1.0 (prepatellar); for bulge sign 0.47 and balloon sign 0.37. Inter-observer kappa agreement for visible swelling ranged from -0.02 (prepatellar) to 0.65 (infrapatellar), the balloon sign -0.11 to 0.82, patellar tap -0.02 to 0.75 and bulge sign kappa -0.04 to 0.14 or reliability coefficient 0.97. Reliability and diagnostic accuracy tended to be better in experienced observers. Very few data looked at performance of individual clinical tests with sensitivity ranging 18.2-85.7% and specificity 35.3-93.3%, both higher with larger effusions. The majority of unstandardized clinical tests to assess joint effusion in knee OA had relatively low intra- and inter-observer reliability. There is some evidence experience improved reliability and diagnostic accuracy of tests. Currently there is insufficient evidence to recommend any particular test in clinical practice. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Validity of cervical auscultation in the screening for aspiration.

PubMed

Al Hawat, A; Woisard, V; Perez-Begout, L; Sarrabère, E; Grand, S; Puech, M

2014-01-01

Cervical auscultation could improve the performance of bedside swallowing test to predict aspiration, especially silent aspiration. The aim of this study is to compare the predictive values of bedside swallowing test performed with and without cervical auscultation by logopedist students who had intensive training on cervical auscultation. 64 patients were included in the study. They all underwent swallowing test alone, combined swallowing test and cervical auscultation, and videofluoroscopic swallowing study as defined gold standard. Two logopedist students, at the end of their training, performed the auscultation and noted their results. 128 tests were performed, 96% of the tests were judged positive for aspiration. When comparing the results of the two different clinical tests, the detection of clinical signs is not improved by the addition of auscultation. Using a penetration aspiration scale threshold >5, the area under the curve measured for the swallowing test alone was significantly higher than that measured for the combined tests (p = 0.03) (0.66 for the swallowing test alone (95% CI between 0.49 and 0.83), and 0.50 for the combined tests (95% CI between 0.31 and 0.69). This study showed no advantage in performing cervical auscultation with bedside swallowing test. Cervical auscultation seems to hamper the assessment, mainly the perception of wet voice and laryngeal motion. These results are compatible with literature but need further confirmation using studies performed with trained logopedists.

Placental growth factor (alone or in combination with soluble fms-like tyrosine kinase 1) as an aid to the assessment of women with suspected pre-eclampsia: systematic review and economic analysis.

PubMed

Frampton, Geoff K; Jones, Jeremy; Rose, Micah; Payne, Liz

2016-11-01

Pre-eclampsia (PE) prediction based on blood pressure, presence of protein in the urine, symptoms and laboratory test abnormalities can result in false-positive diagnoses. This may lead to unnecessary antenatal admissions and preterm delivery. Blood tests that measure placental growth factor (PlGF) or the ratio of soluble fms-like tyrosine kinase 1 (sFlt-1) to PlGF could aid prediction of PE if either were added to routine clinical assessment or used as a replacement for proteinuria testing. To evaluate the diagnostic accuracy and cost-effectiveness of PlGF-based tests for patients referred to secondary care with suspected PE in weeks 20-37 of pregnancy. Systematic reviews and an economic analysis. Bibliographic databases including MEDLINE, EMBASE, Web of Science and The Cochrane Library and Database of Abstracts of Reviews of Effects were searched up to July 2015 for English-language references. Conferences, websites, systematic reviews and confidential company submissions were also accessed. Systematic reviews of test accuracy and economic studies were conducted to inform an economic analysis. Test accuracy studies were required to include women with suspected PE and report quantitatively the accuracy of PlGF-based tests; their risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) criteria. The economic studies review had broad eligibility criteria to capture any types of economic analysis; critical appraisal employed standard checklists consistent with National Institute for Health and Care Excellence criteria. Study selection, critical appraisal and data extraction in both reviews were performed by two reviewers. An independent economic analysis was conducted based on a decision tree model, using the best evidence available. The model evaluates costs (2014, GBP) from a NHS and Personal Social Services perspective. Given the short analysis time horizon, no discounting was undertaken. Four studies were included in the systematic review of test accuracy: two on Alere's Triage ® PlGF test (Alere, Inc., San Diego, CA, USA) for predicting PE requiring delivery within a specified time and two on Roche Diagnostics' Elecsys ® sFlt-1 to PlGF ratio test (Roche Diagnostics GmbH, Mannheim, Germany) for predicting PE within a specified time. Three studies were included in the systematic review of economic studies, and two confidential company economic analyses were assessed separately. Study heterogeneity precluded meta-analyses of test accuracy or cost-analysis outcomes, so narrative syntheses were conducted to inform the independent economic model. The model predicts that, when supplementing routine clinical assessment for rule-out and rule-in of PE, the two tests would be cost-saving in weeks 20-35 of gestation, and marginally cost-saving in weeks 35-37, but with minuscule impact on quality of life. Length of neonatal intensive care unit stay was the most influential parameter in sensitivity analyses. All other sensitivity analyses had negligible effects on results. No head-to-head comparisons of the tests were identified. No studies investigated accuracy of PlGF-based tests when used as a replacement for proteinuria testing. Test accuracy studies were found to be at high risk of clinical review bias. The Triage and Elecsys tests would save money if added to routine clinical assessment for PE. The magnitude of savings is uncertain, but the tests remain cost-saving under worst-case assumptions. Further research is required to clarify how the test results would be interpreted and applied in clinical practice. This study is registered as PROSPERO CRD42015017670. The National Institute for Health Research Health Technology Assessment programme.

A simple screening test for the detection of metallo-β-lactamase-producing Pseudomonas aeruginosa and Acinetobacter in a tertiary care hospital.

PubMed

Wan Nor Amilah, W A W; Noor Izani, N J; Ng, W K; Ashraful Haq, J

2012-12-01

Clinical utilization of carbapenems remains under threat with the emergence of acquired carbapenemase-producing bacteria, particularly metallo-β-lactamases (MBL). Rapid detection of MBL-producing Gram-negative bacilli is essential to prevent their widespread dissemination. However, no standardized detection method is available for routine laboratory use. The purpose of the study was to evaluate a chelating-agent based double disk synergic test and disk potentiation test for MBL-producing strain detection and to determine the isolation rate of MBL-producing Pseudomonas aeruginosa and Acinetobacter from clinical samples in our tertiary teaching hospital. A total of 22 and 66 imipenem-resistant P. aeruginosa and Acinetobacter isolates respectively were tested with ceftazidime (CAZ) disk by modified double disk synergic test and disk potentiation test using ethylenediaminetetraacetic acid (EDTA) and 2-mercaptopropionic acid (as chelating agents) to detect MBL production. The tests were compared with EDTA-phenanthroline-imipenem (EPI) microdilution MIC test as gold standard. MBL positive strains were detected in 17 (77.3%) P. aeruginosa and 2 (3.5%) Acinetobacter isolates. The disk potentiation test with 2-mercaptopropionic acid (2-MPA) dilution of 1:12 provided the most acceptable sensitivities and specificities (88.2% sensitivity and 100% specificity in P. aeruginosa; 100% sensitivity and specificity in Acinetobacter) compared to other screening methods used in this study. This study provided useful information on the local prevalence of MBL-producing P. aeruginosa and Acinetobacter in our hospital. Disc potentiation test with CAZ/2-MPA disc appears to be reliable and convenient MBL detection method in the routine clinical laboratory.

Evaluation of the need for routine clinical testing of PALB2 c.1592delT mutation in BRCA negative Northern Finnish breast cancer families.

PubMed

Haanpää, Maria; Pylkäs, Katri; Moilanen, Jukka S; Winqvist, Robert

2013-08-13

Testing for mutations in the BRCA1 and BRCA2 genes among high-risk breast cancer patients has become a routine practice among clinical geneticists. Unfortunately, however, the genetic background of a majority of the cases coming to the clinics remains currently unexplained, making genetic counseling rather challenging. In recent years it has become evident world-wide that also women carrying a heterozygous germline mutation in PALB2 are at significantly increased risk of getting breast cancer. We have previously studied the clinical as well as biological impact of the PALB2 c.1592delT founder mutation occurring in about 1% of Finnish breast cancer patients unselected for their family history of disease, and our results demonstrated a 40% increased breast cancer risk by age 70 for female mutation carriers. Thus, this relatively common mutation in PALB2 is associated with a high risk of developing breast cancer. The aim of the current study was to analyze whether female index individuals of breast cancer families who had tested negative for germline mutations in BRCA1/BRCA2 as part of genetic counseling services should be offered mutation testing for PALB2 c.1592delT. The study cohort consisted of altogether 223 individuals who had contacted the Department of Clinical Genetics at the Oulu University Hospital in Finland between the years 1997 and 2011 for counseling on hereditary breast and/or ovarian cancer risk. 101 of them met our inclusion criteria. Of these, 10 persons were now deceased, but 6 of them had participated in one of our previous studies on PALB2. Seventy (77%) of the remaining 91 persons responded positively to our study invitation. Chart review of updated pedigree data led to the exclusion of 14 further individuals not meeting the selection criteria. Of the 56 alive affected female individuals screened for PALB2 c.1592delT, altogether two (3.6%) tested positive for this mutation. In addition, of the previously tested but now deceased 6 persons eligible for the current study, one more mutation carrier was observed. Therefore, overall 4.8% (3/62) of the tested individuals belonging to the Northern Finnish 1997-2011 study cohort turned out to be carriers of the PALB2 c.1592delT allele. Given the potential benefits versus harms of this testing, the result of our study suggest that PALB2 c.1592delT should be a routine part of the genetic counseling protocol for Finnish high-risk breast cancer cases tested negative for mutations in BRCA1/BRCA2.

Pigment tests evaluated by a model of chromatic discrimination.

PubMed

Smith, V C; Pokorny, J; Yeh, T

1993-08-01

Clinical color-vision tests are evaluated within the framework of a model of chromatic discrimination in terms of cone excitation. The motivation for this study was to derive a method for evaluation of test design, test sensitivity, and observer performance. The discrimination model is based on the assumption that chromatic discrimination is mediated in two independent channels, one for short-wavelength cones and one for long- and middle-wavelength cones. Luminance-dependent templates are derived for each channel, and they describe chromatic-discrimination behavior of the young color-normal observer. The templates incorporate receptor- and opponent-level gain controls. We show how the chromaticities of clinical tests can be calculated in cone-excitation units and how discrimination behavior on the tests can be plotted on the templates. The tests include the Farnsworth-Munsell 100-hue, the Farnsworth Panel D-15, the Farnsworth Panel D-15 desaturated, the American Optical Hardy-Rand-Rittler, the Farnsworth F2 plate, the Standard Pseudoisochromatic Plates, Part II, the Ishihara, and the Minimalist tests. Clinical-test data collected on young color-normal observers at different illumination levels show the validity of the techniques.

A practical blueprint to systematically study life-long health consequences of novel medically assisted reproductive treatments

PubMed Central

Mulder, Callista L; Serrano, Joana B; Catsburg, Lisa A E; Roseboom, Tessa J; Repping, Sjoerd; van Pelt, Ans M M

2018-01-01

Abstract In medicine, safety and efficacy are the two pillars on which the implementation of novel treatments rest. To protect the patient from unnecessary or unsafe treatments, usually, a stringent path of (pre) clinical testing is followed before a treatment is introduced into routine patient care. However, in reproductive medicine several techniques have been clinically introduced without elaborate preclinical studies. Moreover, novel reproductive techniques may harbor safety risks not only for the patients undergoing treatment, but also for the offspring conceived through these techniques. If preclinical (animal) studies were performed, efficacy and functionality the upper hand. When a new medically assisted reproduction (MAR) treatment was proven effective (i.e. if it resulted in live birth) the treatment was often rapidly implemented in the clinic. For IVF, the first study on the long-term health of IVF children was published a decade after its clinical implementation. In more recent years, prospective follow-up studies have been conducted that provided the opportunity to study the health of large groups of children derived from different reproductive techniques. Although such studies have indicated differences between children conceived through MAR and children conceived naturally, results are often difficult to interpret due to the observational nature of these studies (and the associated risk of confounding factors, e.g. subfertility of the parents), differences in definitions of clinical outcome measures, lack of uniformity in assessment protocols and heterogeneity of the underlying reasons for fertility treatment. With more novel MARs waiting at the horizon, there is a need for a framework on how to assess safety of novel reproductive techniques in a preclinical (animal) setting before they are clinically implemented. In this article, we provide a blueprint for preclinical testing of safety and health of offspring generated by novel MARs using a mouse model involving an array of tests that comprise the entire lifespan. We urge scientists to perform the proposed extensive preclinical tests for novel reproductive techniques with the goal to acquire knowledge on efficacy and the possible health effects of to-be implemented reproductive techniques to safeguard quality of novel MARs. PMID:29635479

Validation, Intrarater and Interrater Reliability Study of the Lateral-Anterior Drawer Test for Detecting Posterior Cruciate Ligament Ruptures: Study Protocol of a Prospective Controlled Single-Blinded Cross-Sectional Study.

PubMed

Seeber, Gesine H; Thalhamer, Christoph; Hahne, Julia; Matthijs, Omer

2018-05-29

Commonly used clinical tests for posterior cruciate ligament (PCL) rupture detection exhibit several limitations, thus requiring more precise clinical PCL tests. The lateral-anterior drawer (LAD) test has been proposed as a manually applied testing alternative but not yet been evaluated in vivo. Fifteen patients presenting with an MRI-confirmed acute or chronic unilateral PCL rupture and 15 subjects with no prior knee injury in their medical history will be included in this prospective single-blinded cross-sectional cohort study. Three examiners with different lengths of working experience (range 1-30 years), blinded to MRI outcomes and patient history, will use the LAD test on both knees of each participant to test for PCL integrity. Examiners will independently document the PCL status of each knee on a blank case report form. Fleiss-Kappa values will be calculated to investigate whether the LAD test shows clinically significant interrater and intrarater reliability. Furthermore, LAD test outcomes will be compared with MRI which serves as reference standard to check for concurrent validity. Moreover, LAD test accuracy with respect to tester experience will be evaluated. The study will be conducted in agreement with the World Medical Association Declaration of Helsinki (2013). Ethical permission (EK16-081-0616) to conduct this study was obtained from the review board of the city of Vienna on 1 September 2016. All personal and research data will be used in accordance with the Austrian Federal Data Protection Act and will be anonymised before publication in relevant international peer-reviewed journals. DRKS00013268; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The cost of implementing rapid HIV testing in sexually transmitted disease clinics in the United States.

PubMed

Eggman, Ashley A; Feaster, Daniel J; Leff, Jared A; Golden, Matthew R; Castellon, Pedro C; Gooden, Lauren; Matheson, Tim; Colfax, Grant N; Metsch, Lisa R; Schackman, Bruce R

2014-09-01

Rapid HIV testing in high-risk populations can increase the number of persons who learn their HIV status and avoid spending clinic resources to locate persons identified as HIV infected. We determined the cost to sexually transmitted disease (STD) clinics of point-of-care rapid HIV testing using data from 7 public clinics that participated in a randomized trial of rapid testing with and without brief patient-centered risk reduction counseling in 2010. Costs included counselor and trainer time, supplies, and clinic overhead. We applied national labor rates and test costs. We calculated median clinic start-up costs and mean cost per patient tested, and projected incremental annual costs of implementing universal rapid HIV testing compared with current testing practices. Criteria for offering rapid HIV testing and methods for delivering nonrapid test results varied among clinics before the trial. Rapid HIV testing cost an average of US $22/patient without brief risk reduction counseling and US $46/patient with counseling in these 7 clinics. Median start-up costs per clinic were US $1100 and US $16,100 without and with counseling, respectively. Estimated incremental annual costs per clinic of implementing universal rapid HIV testing varied by whether or not brief counseling is conducted and by current clinic testing practices, ranging from a savings of US $19,500 to a cost of US $40,700 without counseling and a cost of US $98,000 to US $153,900 with counseling. Universal rapid HIV testing in STD clinics with same-day results can be implemented at relatively low cost to STD clinics, if brief risk reduction counseling is not offered.

A cross-sectional study of attitudes about the use of genetic testing for clinical care among patients with an alcohol use disorder.

PubMed

Strobel, Brittany; McManus, Lauren; Leong, Shirley; Blow, Frederic; Slaymaker, Valerie; Berrettini, Wade; Gordon, Adam J; O'Brien, Charles; Oslin, David

2013-01-01

Modification and individualization of medical treatments due to genetic testing has the potential to revolutionize healthcare delivery. As evidence mounts that genetic testing may improve treatment decisions for patients with alcohol use disorder (AUD), we explored patient concerns and attitudes toward genetic testing. Subjects of two USA cross-sectional AUD studies were surveyed regarding their attitudes regarding the use of genetic testing for AUD treatment. Four hundred and fifty-seven participants were surveyed. Overall, subjects showed a high degree of willingness to provide DNA for clinical use and recognized genetics as important to the pathophysiology of a number of disorders including AUD. There were, however, significant concerns expressed related to insurance denial or employment problems. We found that patients enrolled in AUD studies had some concerns about use of genetic testing. The patients in these two samples were, however, willing and knowledgeable about providing DNA samples.

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.

Preliminary evaluation of the impact of a Web-based HIV testing programme in Abruzzo Region on the prevention of late HIV presentation and associated mortality.

PubMed

Polilli, Ennio; Sozio, Federica; Di Stefano, Paola; Clerico, Luigi; Di Iorio, Giancarlo; Parruti, Giustino

2018-04-01

This study aimed to analyze the efficacy of a Web-based testing programme in terms of the prevention of late HIV presentation. The clinical characteristics of patients diagnosed with HIV via the Web-based testing programme were compared to those of patients diagnosed in parallel via standard diagnostic care procedures. This study included the clinical and demographic data of newly diagnosed HIV patients enrolled at the study clinic between February 2014 and June 2017. These patients were diagnosed either via standard diagnostic procedures or as a result of the Web-based testing programme. Eighty-eight new cases of HIV were consecutively enrolled; their mean age was 39.1±13.0 years. Fifty-nine patients (67%) were diagnosed through standard diagnostic procedures and 29 (33%) patients came from the Web-based testing programme. Late presentation (62% vs. 34%, p=0.01) and AIDS-defining conditions at presentation (13 vs. 1, p=0.02) were significantly more frequent in the standard care group than in the Web-based group; four of 13 patients with AIDS diagnosed under standard diagnostic procedures died, versus none in the Web-based testing group (p<0.001). Web-based recruitment for voluntary and free HIV testing helped to diagnose patients with less advanced HIV disease and no risk of death, from all at-risk groups, in comparison with standard care testing. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Collaborative derivation of reference intervals for major clinical laboratory tests in Japan.

PubMed

Ichihara, Kiyoshi; Yomamoto, Yoshikazu; Hotta, Taeko; Hosogaya, Shigemi; Miyachi, Hayato; Itoh, Yoshihisa; Ishibashi, Midori; Kang, Dongchon

2016-05-01

Three multicentre studies of reference intervals were conducted recently in Japan. The Committee on Common Reference Intervals of the Japan Society of Clinical Chemistry sought to establish common reference intervals for 40 laboratory tests which were measured in common in the three studies and regarded as well harmonized in Japan. The study protocols were comparable with recruitment mostly from hospital workers with body mass index ≤28 and no medications. Age and sex distributions were made equal to obtain a final data size of 6345 individuals. Between-subgroup differences were expressed as the SD ratio (between-subgroup SD divided by SD representing the reference interval). Between-study differences were all within acceptable levels, and thus the three datasets were merged. By adopting SD ratio ≥0.50 as a guide, sex-specific reference intervals were necessary for 12 assays. Age-specific reference intervals for females partitioned at age 45 were required for five analytes. The reference intervals derived by the parametric method resulted in appreciable narrowing of the ranges by applying the latent abnormal values exclusion method in 10 items which were closely associated with prevalent disorders among healthy individuals. Sex- and age-related profiles of reference values, derived from individuals with no abnormal results in major tests, showed peculiar patterns specific to each analyte. Common reference intervals for nationwide use were developed for 40 major tests, based on three multicentre studies by advanced statistical methods. Sex- and age-related profiles of reference values are of great relevance not only for interpreting test results, but for applying clinical decision limits specified in various clinical guidelines. © The Author(s) 2015.

An exploratory study on emotion recognition in patients with a clinically isolated syndrome and multiple sclerosis.

PubMed

Jehna, Margit; Neuper, Christa; Petrovic, Katja; Wallner-Blazek, Mirja; Schmidt, Reinhold; Fuchs, Siegrid; Fazekas, Franz; Enzinger, Christian

2010-07-01

Multiple sclerosis (MS) is a chronic multifocal CNS disorder which can affect higher order cognitive processes. Whereas cognitive disturbances in MS are increasingly better characterised, emotional facial expression (EFE) has rarely been tested, despite its importance for adequate social behaviour. We tested 20 patients with a clinically isolated syndrome suggestive of MS (CIS) or MS and 23 healthy controls (HC) for the ability to differ between emotional facial stimuli, controlling for the influence of depressive mood (ADS-L). We screened for cognitive dysfunction using The Faces Symbol Test (FST). The patients demonstrated significant decreased reaction-times regarding emotion recognition tests compared to HC. However, the results also suggested worse cognitive abilities in the patients. Emotional and cognitive test results were correlated. This exploratory pilot study suggests that emotion recognition deficits might be prevalent in MS. However, future studies will be needed to overcome the limitations of this study. Copyright 2010 Elsevier B.V. All rights reserved.

'Mechanical restraint-confounders, risk, alliance score': testing the clinical validity of a new risk assessment instrument.

PubMed

Deichmann Nielsen, Lea; Bech, Per; Hounsgaard, Lise; Alkier Gildberg, Frederik

2017-08-01

Unstructured risk assessment, as well as confounders (underlying reasons for the patient's risk behaviour and alliance), risk behaviour, and parameters of alliance, have been identified as factors that prolong the duration of mechanical restraint among forensic mental health inpatients. To clinically validate a new, structured short-term risk assessment instrument called the Mechanical Restraint-Confounders, Risk, Alliance Score (MR-CRAS), with the intended purpose of supporting the clinicians' observation and assessment of the patient's readiness to be released from mechanical restraint. The content and layout of MR-CRAS and its user manual were evaluated using face validation by forensic mental health clinicians, content validation by an expert panel, and pilot testing within two, closed forensic mental health inpatient units. The three sub-scales (Confounders, Risk, and a parameter of Alliance) showed excellent content validity. The clinical validations also showed that MR-CRAS was perceived and experienced as a comprehensible, relevant, comprehensive, and useable risk assessment instrument. MR-CRAS contains 18 clinically valid items, and the instrument can be used to support the clinical decision-making regarding the possibility of releasing the patient from mechanical restraint. The present three studies have clinically validated a short MR-CRAS scale that is currently being psychometrically tested in a larger study.

Performance of a lateral flow immunochromatography test for the rapid diagnosis of active tuberculosis in a large multicentre study in areas with different clinical settings and tuberculosis exposure levels.

PubMed

Manga, Selene; Perales, Rocio; Reaño, Maria; D'Ambrosio, Lia; Migliori, Giovanni Battista; Amicosante, Massimo

2016-11-01

Tuberculosis (TB) continues to cause an outsized burden of morbidity and mortality worldwide, still missing efficient and largely accessible diagnostic tools determining an appropriate control of the disease. Serological tests have the potentially to impact TB diagnosis, in particular in extreme clinical settings. The diagnostic performances of the TB-XT HEMA EXPRESS (HEMA-EXPRESS) immunochromatographic rapid test for active TB diagnosis, based on use of multiple Mycobacterium tuberculosis (MTB) specific antigens, have been evaluated in a large study multicentre TB case-finding study, in populations with different exposure level to TB. A total of 1,386 subjects were enrolled in the six participating centres in Peru: 290 active-TB and 1,096 unaffected subjects. The TB prevalence (overall 20.5%) varied between 4.0% and 41.1% in the different study groups. Overall, the HEMA-EXPRESS test had 30.6% sensitivity (range 3.9-77.9%) and 84.6% specificity (range 51.6-97.3%). A significant inverse correlation between test accuracy (overall 73.5%, range 40.4-96.4%) and TB prevalence in the various study populations was observed (Pearson's r=-0.7985; P=0.05). HEMA-EXPRESS, is rapid and relatively inexpensive test suitable for routine use in TB diagnosis. In low TB prevalence conditions, test performance appears in line with WHO Target Product Profile for TB diagnostics. Performances appear suboptimal in high TB prevalence settings. Appropriate set-up in operative clinical settings has to be considered for novel serological tests for TB diagnosis, particularly for formats suitable for point-of-care use.

The Utilization of a Clinical Decision Support System to Manage Adult Type 2 Diabetes: A Correlational Study

ERIC Educational Resources Information Center

Faught, I. Charie

2012-01-01

While the Institute of Medicine (2001) has promoted health information technology to improve the process of care such as compliance with clinical practice guidelines and quicker access to clinical information, diagnostic tests, and treatment results, very little was known about how a clinical decision support system can contribute to diabetes…

The current status of oral contraceptive clinical development in Japan.

PubMed

Kuwabara, Y

1989-01-01

Since the oral contraceptive guideline was issued in April 1987, Japanese pharmaceutical firms have been asking physicians to perform clinical studies of the low-dose OCs. At present, eight products from six companies are under clinical development. Ethinyl estradiol (30-35 micrograms per tablet) as an estrogen component is common to all the test drugs. The progestin component in each OC is norethindrone, levonorgestrel, or desogestrel. Phase I clinical studies on small numbers of healthy volunteers showed that they could tolerate the test drugs without any serious complaints. The effects on endocrine systems, including the inhibition of ovulation, were also examined. Pharmacokinetic parameters of active ingredients were comparable to those of Western women, and no substantial difference seemed to exist between Japanese and Western women. As an example, the results of phase I studies of OJK-777 (Ortho-Novum 7/7/7) are mentioned. Phase III clinical studies, which are "open studies," are now under progress with more than 3,000 women. The major objectives are to examine (1) how well the drugs are tolerated, and the dropout rates; (2) the effects on cycle control, especially bleeding patterns; (3) effects on the cardiovascular system, including coagulation and lipid metabolism; (4) effects on hormone secretions. Although some women have been taking the test drugs for more than 12 cycles, overall statistics are not yet available, because the guideline requires long-term administration (for more than 24 cycles). However, some characteristic features observed thus far are discussed.

B-type natriuretic peptide and its clinical utility in patients with heart failure.

PubMed

Wu, A H

2001-10-01

The implementation of entirely new clinical laboratory tests such as BNP assays is much more difficult today than it ever has been in the past. Medicare and Medicaid have been operating for many years on fixed reimbursements based on Diagnosis Related Groups (DRGs). Many third-party payers now have capitated contracts, i.e., a fixed reimbursement per member per month, regardless of the number of tests ordered and performed. Laboratories are now cost centers and not sources of revenue, thus the limited amount of income from fee-for-service reimbursements may not sufficient to cover the expenses for performing all testing. Therefore, in order to justify BNP testing, laboratory directors and hospital administrators must be able to demonstrate that implementation of BNP testing results in a savings for the hospital as a whole, even if the laboratory has a negative cost balance. If BNP testing can lead to a reduction or elimination of other tests, or if it improves the efficiency and accuracy of CHF diagnosis so that the number of inappropriate admissions is reduced, the test may be justified. Table 2 lists some specific areas where BNP might impact the other clinical areas. Outcome studies should be performed to determine if any of these changes in clinical practices can be justified.

Standardizing in vitro diagnostics tasks in clinical trials: a call for action.

PubMed

Lippi, Giuseppe; Simundic, Ana-Maria; Rodriguez-Manas, Leocadio; Bossuyt, Patrick; Banfi, Giuseppe

2016-05-01

Translational research is defined as the process of applying ideas, insights and discoveries generated through basic scientific inquiry to treatment or prevention of human diseases. Although precise information is lacking, several lines of evidence attest that up to 95% early-phase studies may not translate into tangible outcomes for improving clinical management. Major theoretical hurdles exist in the translational process, but is it also undeniable that many studies may have failed for practical reasons, such as the use of inappropriate diagnostic testing for evaluating efficacy, effectiveness or safety of a given medical intervention, or poor quality in laboratory testing. This can generate biased test results and result in misconceptions during data interpretation, eventually leading to no clinical benefit, possible harm, and a waste of valuable resources. From a genuine economic perspective, it can be estimated that over 10 million euros of funding may be lost each year in clinical trials in the European Union due to preanalytical and analytical problems. These are mostly attributions to the heterogeneity of current guidelines and recommendations for the testing process, to the poor evidence base for basic pre-analytical, analytical and post-analytical requirements in clinical trials, and to the failure to thoughtfully integrate the perspectives of clinicians, patients, nurses and diagnostic companies in laboratory best practices. The most rational means for filling the gap between what we know and what we practice in clinical trials cannot discount the development of multidisciplinary teams including research scientists, clinicians, nurses, patients associations and representative of in vitro diagnostic (IVD) companies, who should actively interplay and collaborate with laboratory professionals to adapt and disseminate evidence-based recommendations about biospecimen collection and management into the research settings, from preclinical to phase III studies.

A Pilot Study of a Culturally Targeted Video Intervention to Increase Participation of African American Patients in Cancer Clinical Trials

PubMed Central

Libin, Alexander V.; Wang, Hong; Swain, Sandra M.

2012-01-01

Purpose. Barriers to clinical trial participation among African American cancer patients are well characterized in the literature. Attitudinal barriers encompassing fear, distrust, and concerns about ethical misconduct are also well documented. To increase trial accrual, these attitudes must be adequately addressed, yet there remains a lack of targeted interventions toward this end. We developed a 15-minute culturally targeted video designed to impact six specific attitudes of African American cancer patients toward therapeutic trials. We conducted a pilot study to test in the first such intervention to increase intention to enroll. Patients and Methods. The primary study outcome was self-reported likelihood to participate in a therapeutic trial. Using a mixed methods approach, we developed the Attitudes and Intention to Enroll in Therapeutic Clinical Trials (AIET) instrument, a 30-item questionnaire measuring six attitudinal barriers to African American trial participation. We enrolled 108 eligible active treatment patients at a large urban cancer institute. McNemar's test for matched pairs was used to assess changes in attitudes and likelihood to enroll in a clinical trial at baseline and immediately after the video. Pre- and post-video AIET summative scores were analyzed by paired t-test for each attitudinal barrier. Results. Patients' likelihood of enrolling in a clinical trial significantly increased post-video with 36% of the sample showing positive changes in intention [McNemar's χ2 = 33.39, p < .001]. Paired t-tests showed significant changes in all six attitudinal barriers measured via AIET summative scores from pre- to post-video. Conclusion. These data suggest utility of our video for increasing African American participation in clinical trials. PMID:22639112