Problems in specimen collection for sexually transmitted diseases.

PubMed

Larsen, B

1985-03-01

Laboratory methods for the diagnosis of sexually transmitted diseases (STDs) are continuously undergoing improvement. It remains the responsibility of the clinician to become familiar with the tests available for the diagnosis of STDs. Those tests depend on obtaining clinical specimens from the proper site and on transporting them to the laboratory under satisfactory conditions.

Comparison of outcomes in patients undergoing defibrillation threshold testing at the time of implantable cardioverter-defibrillator implantation versus no defibrillation threshold testing.

PubMed

Hall, Burr; Jeevanantham, Vinodh; Levine, Ethan; Daubert, James; McNitt, Scott; Hall, Freburr; Jeevanantham, Vinodh; Levine, Ethan; Daubert, James; McNitt, Scott; Hall, Fred Morady And Frank Pelosiburr; Jeevanantham, Vinodh; Levine, Ethan; Daubert, James; McNitt, Scott; Morady, Fred Morady And Frank Pelosid; Pelosi, Frank

2007-01-01

Inability to perform defibrillation threshold (DFT) testing during implantable cardioverter defibrillator (ICD) implantation due to co-morbidities may influence long-term survival. Retrospective review at The University of Michigan (1999-2004) identified 55 patients undergoing ICD implantation without DFT testing ("No-DFT group"). A randomly selected sample of patients (n = 57) undergoing standard DFT testing ("DFT group") was compared in terms of appropriate shocks, clinical shock efficacy and all-cause mortality. DFT testing was withheld due to hypotension, atrial fibrillation with inability to exclude left atrial thrombus, left ventricular thrombus, CHF and/or ischemia. The No-DFT group had a similar appropriate shock rate, but lower total survival (69.1% vs. 91.2%, p = 0.004) than the DFT group. The No-DFT group had a higher incidence of ventricular fibrillation (VF) episodes (9.1% vs. 3.1%, p = 0.037), and deaths attributable to VF (3 of 17 deaths vs. 0 of 5 deaths) compared to the DFT group. Multivariate analysis found a trend toward increased risk of death in the No-DFT group (HR 3.18, 95% CI 0.82-12.41, p = 0.095) after adjusting for baseline differences in gender distribution, NYHA class and prior CABG. In summary, overall mortality was higher in the No-DFT group. More deaths attributable to VF occurred in the No-DFT group. Thus, DFT testing should therefore remain the standard of care. Nevertheless, ICD therapy should not be withheld in patients who meet appropriate implant criteria simply on the basis of clinical scenarios that preclude routine DFT testing. (Cardiol J 2007; 14: 463-469).

Analytical and clinical performance of the Hologic Aptima HCV Quant Dx Assay for the quantification of HCV RNA in plasma samples.

PubMed

Schønning, Kristian; Pedersen, Martin Schou; Johansen, Kim; Landt, Bodil; Nielsen, Lone Gilmor; Weis, Nina; Westh, Henrik

2017-10-01

Chronic hepatitis C virus (HCV) infection can be effectively treated with directly acting antiviral (DAA) therapy. Measurement of HCV RNA is used to evaluate patient compliance and virological response during and after treatment. To compare the analytical performance of the Aptima HCV Quant Dx Assay (Aptima) and the COBAS Ampliprep/COBAS TaqMan HCV Test v2.0 (CAPCTMv2) for the quantification of HCV RNA in plasma samples, and compare the clinical utility of the two tests in patients undergoing treatment with DAA therapy. Analytical performance was evaluated on two sets of plasma samples: 125 genotyped samples and 172 samples referred for quantification of HCV RNA. Furthermore, performance was evaluated using dilutions series of four samples containing HCV genotype 1a, 2b, 3a, and 4a, respectively. Clinical utility was evaluated on 118 plasma samples obtained from 13 patients undergoing treatment with DAAs. Deming regression of results from 187 plasma samples with HCV RNA >2 Log IU/mL indicated that the Aptima assay quantified higher than the CAPCTMv2 test for HCV RNA >4.9 Log IU/mL. The linearity of the Aptima assay was excellent across dilution series of four HCV genotypes (slope of the regression line: 1.00-1.02). The Aptima assay detected significantly more replicates below targeted 2 Log IU/mL than the CAPCTMv2 test, and yielded clearly interpretable results when used to analyze samples from patients treated with DAAs. The analytical performance of the Aptima assay makes it well suited for monitoring patients with chronic HCV infection undergoing antiviral treatment. Copyright © 2017 Elsevier B.V. All rights reserved.

Molecular diagnostics of lung cancer in the clinic.

PubMed

Sholl, Lynette

2017-10-01

According to current practice guidelines, all patients with advanced non-small cell lung cancer (NSCLC) should undergo predictive biomarker testing. For squamous cell carcinoma patients, PD-L1 immunohistochemistry is indicated to select patients for immunotherapy in the first line. For lung adenocarcinoma, all patients with advanced disease should undergo testing for epidermal growth factor receptor ( EGFR ) mutations, ALK and ROS1 rearrangements, and PD-L1 expression to predict response to EGFR, ALK, or ROS1 targeted inhibitors or immunotherapy, respectively. Besides these, a number of other biomarkers are under clinical investigation as predictors of response to targeted therapies, including BRAF , ERBB2 , MET splice mutations and amplification, and RET rearrangements. Successful testing for this complex array of molecular targets demands careful coordination between proceduralists, pathologists and molecular laboratories to ensure proper tumor tissue handling following biopsy as well as judicious use of diagnostic immunohistochemistry. Even so, sample failure rates due to inadequate tumor tissue are high in practice, particularly when using sequential testing methods. Use of next generation sequencing (NGS) in clinical practice can enable detection of multiple targets and multiple alteration types (mutation, gene copy change, and rearrangement) simultaneously even with small amounts of input nucleic acids, thus increasing molecular testing success rates. In patients with an established lung cancer diagnosis but with prohibitively limited amounts of tumor tissue or who are experiencing relapse, analyses of circulating tumor DNA (ctDNA) from the plasma can serve as an alternate testing substrate, however the more limited clinical sensitivity of this approach must be taken into account. This review will explore the indications for and pitfalls of routine NGS and plasma genotyping in the clinic, including the intersection of these technologies.

Molecular diagnostics of lung cancer in the clinic

PubMed Central

2017-01-01

According to current practice guidelines, all patients with advanced non-small cell lung cancer (NSCLC) should undergo predictive biomarker testing. For squamous cell carcinoma patients, PD-L1 immunohistochemistry is indicated to select patients for immunotherapy in the first line. For lung adenocarcinoma, all patients with advanced disease should undergo testing for epidermal growth factor receptor (EGFR) mutations, ALK and ROS1 rearrangements, and PD-L1 expression to predict response to EGFR, ALK, or ROS1 targeted inhibitors or immunotherapy, respectively. Besides these, a number of other biomarkers are under clinical investigation as predictors of response to targeted therapies, including BRAF, ERBB2, MET splice mutations and amplification, and RET rearrangements. Successful testing for this complex array of molecular targets demands careful coordination between proceduralists, pathologists and molecular laboratories to ensure proper tumor tissue handling following biopsy as well as judicious use of diagnostic immunohistochemistry. Even so, sample failure rates due to inadequate tumor tissue are high in practice, particularly when using sequential testing methods. Use of next generation sequencing (NGS) in clinical practice can enable detection of multiple targets and multiple alteration types (mutation, gene copy change, and rearrangement) simultaneously even with small amounts of input nucleic acids, thus increasing molecular testing success rates. In patients with an established lung cancer diagnosis but with prohibitively limited amounts of tumor tissue or who are experiencing relapse, analyses of circulating tumor DNA (ctDNA) from the plasma can serve as an alternate testing substrate, however the more limited clinical sensitivity of this approach must be taken into account. This review will explore the indications for and pitfalls of routine NGS and plasma genotyping in the clinic, including the intersection of these technologies. PMID:29114472

Clinical predictors of elective total joint replacement in persons with end-stage knee osteoarthritis.

PubMed

Zeni, Joseph A; Axe, Michael J; Snyder-Mackler, Lynn

2010-05-06

Arthritis is a leading cause of disability in the United States. Total knee arthroplasty (TKA) has become the gold standard to manage the pain and disability associated with knee osteoarthritis (OA). Although more than 400,000 primary TKA surgeries are performed each year in the United States, not all individuals with knee OA elect to undergo the procedure. No clear consensus exists on criteria to determine who should undergo TKA. The purpose of this study was to determine which clinical factors will predict the decision to undergo TKA in individuals with end-stage knee OA. Knowledge of these factors will aid in clinical decision making for the timing of TKA. Functional data from one hundred twenty persons with end-stage knee OA were obtained through a database. All of the individuals complained of knee pain during daily activities and had radiographic evidence of OA. Functional and clinical tests, collectively referred to as the Delaware Osteoarthritis Profile, were completed by a physical therapist. This profile consisted of measuring height, weight, quadriceps strength and active knee range of motion, while functional mobility was assessed using the Timed Up and Go (TUG) test and the Stair Climbing Task (SCT). Self-perceived functional ability was measured using the activities of daily living subscale of the Knee Outcome Survey (KOS-ADLS). A logistic regression model was used to identify variables predictive of TKA use. Forty subjects (33%) underwent TKA within two years of evaluation. These subjects were significantly older and had significantly slower TUG and SCT times (p < 0.05). Persons that underwent TKA were also significantly weaker, had lower self-reported function and had less knee extension than persons who did not undergo TKA. No differences between groups were seen for BMI, gender, knee flexion ROM and unilateral versus bilateral joint disease. Using backward regression, age, knee extension ROM and KOS-ADLS together significantly predicted whether or not a person would undergo TKA (p

Anxiety levels in women undergoing prenatal maternal serum screening for Down syndrome: the effect of a fast reporting system by mobile phone short-message service.

PubMed

Cheng, Po-Jen; Wu, Tzong-Lin; Shaw, Sheng-Wen; Chueh, Ho-Yen; Lin, Cheng-Tao; Hsu, Jenn-Jeih; Hsieh, T'sang-T'ang; Soong, Yung-Kuei

2008-05-01

To study the effect of fast reporting by mobile phone short-message service (SMS) on anxiety levels in women undergoing prenatal biochemical screening for Down syndrome. From January 2005 to December 2006, 2782 women undergoing prenatal biochemical serum screening were randomized into fast reporting by SMS (group A) or without mobile phone reporting (group B). Anxiety levels were measured with the Spielberger State-Trait Anxiety Inventory (STAI) before prenatal screen testing, before the appointed clinic (when the SMS report had already been given to group A), and 3 days after the appointed clinic (when the full screening report had been given to groups A and B). For screen-negative women, anxiety scores did not differ between groups before prenatal screen testing and 3 days after the appointed clinic. The state-anxiety scores measured on the second occasion had declined significantly in group A. The state-anxiety scores in both groups increased over the 3-week period after being informed of positive screen results. The trait- and state-anxiety scores at all points did not differ between the two groups of screen-positive women. The provision of a routine reporting system plus additional SMS report revealed some overall benefits in reducing anxiety among women with screen-negative result. 2008 John Wiley & Sons, Ltd

Clinically Enhancing Local Anesthesia Techniques for Endodontic Treatment.

PubMed

Bahcall, James; Xie, Qian

2017-02-01

Local anesthesia is one of the most important drugs given to patients who undergo endodontic treatment. Yet, clinicians often do not view local anesthetic agents as drugs and, therefore, struggle clinically to consistently achieve profound pulpal anesthesia. To improve the clinical effects of local anesthesia for endodontic treatment, in conjunction with selecting the correct type of local anesthesia, clinicians need to thoroughly understand how the local anesthetic process works and how to objectively test for clinical signs of pulpal anesthesia and integrate supplemental anesthesia when appropriate.

Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation.

PubMed

Levett, D Z H; Jack, S; Swart, M; Carlisle, J; Wilson, J; Snowden, C; Riley, M; Danjoux, G; Ward, S A; Older, P; Grocott, M P W

2018-03-01

The use of perioperative cardiopulmonary exercise testing (CPET) to evaluate the risk of adverse perioperative events and inform the perioperative management of patients undergoing surgery has increased over the last decade. CPET provides an objective assessment of exercise capacity preoperatively and identifies the causes of exercise limitation. This information may be used to assist clinicians and patients in decisions about the most appropriate surgical and non-surgical management during the perioperative period. Information gained from CPET can be used to estimate the likelihood of perioperative morbidity and mortality, to inform the processes of multidisciplinary collaborative decision making and consent, to triage patients for perioperative care (ward vs critical care), to direct preoperative interventions and optimization, to identify new comorbidities, to evaluate the effects of neoadjuvant cancer therapies, to guide prehabilitation and rehabilitation, and to guide intraoperative anaesthetic practice. With the rapid uptake of CPET, standardization is key to ensure valid, reproducible results that can inform clinical decision making. Recently, an international Perioperative Exercise Testing and Training Society has been established (POETTS www.poetts.co.uk) promoting the highest standards of care for patients undergoing exercise testing, training, or both in the perioperative setting. These clinical cardiopulmonary exercise testing guidelines have been developed by consensus by the Perioperative Exercise Testing and Training Society after systematic literature review. The guidelines have been endorsed by the Association of Respiratory Technology and Physiology (ARTP). Copyright © 2017. Published by Elsevier Ltd.

"Am I carrier?" The patient's lived experience of thrombophilia genetic screening and its outcome.

PubMed

Graffigna, Guendalina; Leone, Daniela; Vegni, Elena

2014-01-01

How do patients with thrombophilia experience a physician's request to undergo a genetic test? How do they experience the test outcome? To answer these questions, we conducted an interpretative phenomenological analysis study, based on 10 in-depth interviews with patients who underwent genetic testing for thrombophilia in Italy, half with positive and half with negative results. The experience of undergoing genetic screening for thrombophilia plays an important role in reconfiguring patients' signification of their illness experience. A positive outcome becomes a cue to reorganize in a more adaptive way the illness meaning at the cognitive and emotive levels, whereas a negative outcome appears more distressing and confusing. As a clinical implication of the study, clinicians should consider communicating carefully with the patients regardless from the positive/negative test results and they should explore the patient's specific reaction and understanding of test result.

Health Orientation, Knowledge, and Attitudes toward Genetic Testing and Personalized Genomic Services: Preliminary Data from an Italian Sample.

PubMed

Oliveri, Serena; Masiero, Marianna; Arnaboldi, Paola; Cutica, Ilaria; Fioretti, Chiara; Pravettoni, Gabriella

2016-01-01

Objective . The study aims at assessing personality tendencies and orientations that could be closely correlated with knowledge, awareness, and interest toward undergoing genetic testing. Methods. A sample of 145 subjects in Italy completed an online survey, investigating demographic data, health orientation, level of perceived knowledge about genetic risk, genetic screening, and personal attitudes toward direct to consumer genetic testing (DTCGT). Results . Results showed that respondents considered genetic assessment to be helpful for disease prevention, but they were concerned that results could affect their life planning with little clinical utility. Furthermore, a very high percentage of respondents (67%) had never heard about genetic testing directly available to the public. Data showed that personality tendencies, such as personal health consciousness, health internal control, health esteem, and confidence, motivation to avoid unhealthiness and motivation for healthiness affected the uptake of genetic information and the interest in undergoing genetic testing. Conclusions . Public knowledge and attitudes toward genetic risk and genetic testing among European countries, along with individual personality and psychological tendencies that could affect these attitudes, remain unexplored. The present study constitutes one of the first attempts to investigate how such personality tendencies could motivation to undergo genetic testing and engagement in lifestyle changes.

Health Orientation, Knowledge, and Attitudes toward Genetic Testing and Personalized Genomic Services: Preliminary Data from an Italian Sample

PubMed Central

Arnaboldi, Paola; Cutica, Ilaria; Fioretti, Chiara

2016-01-01

Objective. The study aims at assessing personality tendencies and orientations that could be closely correlated with knowledge, awareness, and interest toward undergoing genetic testing. Methods. A sample of 145 subjects in Italy completed an online survey, investigating demographic data, health orientation, level of perceived knowledge about genetic risk, genetic screening, and personal attitudes toward direct to consumer genetic testing (DTCGT). Results. Results showed that respondents considered genetic assessment to be helpful for disease prevention, but they were concerned that results could affect their life planning with little clinical utility. Furthermore, a very high percentage of respondents (67%) had never heard about genetic testing directly available to the public. Data showed that personality tendencies, such as personal health consciousness, health internal control, health esteem, and confidence, motivation to avoid unhealthiness and motivation for healthiness affected the uptake of genetic information and the interest in undergoing genetic testing. Conclusions. Public knowledge and attitudes toward genetic risk and genetic testing among European countries, along with individual personality and psychological tendencies that could affect these attitudes, remain unexplored. The present study constitutes one of the first attempts to investigate how such personality tendencies could motivation to undergo genetic testing and engagement in lifestyle changes. PMID:28105428

Assessment of the use of oral fluid as a matrix for drug monitoring in patients undergoing treatment for opioid addiction.

PubMed

Kunkel, Frank; Fey, Elizabeth; Borg, Damon; Stripp, Richard; Getto, Christine

2015-01-01

Drug testing is an important clinical tool that is available to physicians who are assessing the effectiveness of drug treatment as well as patient compliance to the administered program. While urine has traditionally been the matrix of choice for drug monitoring, oral fluid, a filtrate of the blood, has shown great promise as an alternative matrix for such applications. Oral fluid collection can be accomplished without the need for highly trained medical staff through the use of a simple, noninvasive oral fluid collection device, which obtains an adequate sample in only a few minutes. There has been a significant amount of research performed on the use of oral fluid for forensic toxicology application; however, more studies assessing the use of oral fluid drug testing are required to validate its ability to achieve clinical drug monitoring goals. Testing for various drugs in oral fluid may yield a different result when compared to the same drugs in urine, requiring an assessment of the utility of oral fluid for such practices. The purpose of this study was to examine the application of oral fluid drug testing in patients undergoing buprenorphine treatment for opioid dependence. A retrospective analysis of drug testing results obtained from 6,928 patients (4,560 unobserved urine collections and 2,368 observed oral fluid collections) monitored for heroin metabolite, amphetamine, benzodiazepines, buprenorphine, tetrahydrocannabinol, cocaine, codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, and oxymorphone was completed. Results of this statistical exercise indicated that patients undergoing observed oral fluid collection tested positive more frequently than those unobserved urine collections for several illicit drugs and prescription medications targeted. Oral fluid was shown to detect illicit drug use as well as noncompliance in this patient population under the studied conditions more often than the urine specimens.

Comparison between the Effects of Rocuronium, Vecuronium, and Cisatracurium Using Train-of-Four and Clinical Tests in Elderly Patients

PubMed Central

Sagir, Ozlem; Yucesoy Noyan, Funda; Koroglu, Ahmet; Cicek, Muslum; Ilksen Toprak, Huseyin

2013-01-01

Background Postoperative residual blockade, longer duration of action for neuromuscular blockade, and slower recovery were relatively common in elderly patients. Objectives We aimed to investigate the safety of train-of-four ratio and clinical tests in the assessment of patient recovery, and to determine the effects of the rocuronium, vecuronium, and cisatracurium on intubation, extubation and recovery times in elderly patients undergoing abdominal surgery. Patients and Methods After obtaining institutional approval and informed consent, 60 patients over 60 years old and undergoing elective abdominal operations were included in this double-blind, randomized clinical trial. Following a standard anesthesia induction, 0.6mg kg-1 rocuronium, 0.1mg kg-1 vecuronium, and 0.1mg kg-1 cisatracurium were administered to the patients in Group R, Group V, and Group C, respectively. Train-of-four (TOF) ratios were recorded at 10-minute intervals during and after the operation. Modified Aldrete Score (MAS) and clinical tests were recorded in the recovery room at 10-minute intervals. In addition, intubation and extubation times, duration of recovery room stay, and any complications were recorded. Results Intubation time was found to be shorter in Group R than that in Groups V and C (P ˂ 0.001). Times to positive visual disturbances and grip strength tests were shorter in Group C than that in Group V (P = 0.016 and P = 0.011, respectively). In Group R and group C, time to TOF ≥ 0.9 was significantly longer than all positive clinical test times except grip strength (P < 0.05). Conclusions We hold the opinion that cisatracurium is safer in elderly patients compared to other drugs. We also concluded that the usage of TOF ratio together with clinical tests is suitable for assessment of neuromuscular recovery in these patients. PMID:24223350

Postoperative hyperglycaemia of diabetic patients undergoing cardiac surgery - a clinical audit.

PubMed

Lehwaldt, Daniela; Kingston, Mary; O'Connor, Sheila

2009-01-01

Previous studies have shown that hyperglycaemia is associated with postoperative complications in cardiac surgical patients. Conversely, well-controlled glucose levels are said to reduce major infectious complications in diabetic patients. The purpose of this clinical audit was to evaluate the blood glucose levels of diabetic patients undergoing cardiac surgery and to determine the effectiveness of postoperative glycaemic control. A group of 150 patients from a large Irish cardiac surgery centre was selected by convenience sampling. An audit tool was designed to capture the patients' blood glucose levels, treatment regimes and postoperative complications. The findings showed major variations between 'high', 'good' and 'borderline' blood glucose levels in the pre- and postoperative phase. Although blood glucose testing practices seemed inconsistent, mean levels measured 'borderline'. Furthermore, the treatment regimes varied greatly and suggest a lack of consensus regarding the management of postoperative hyperglycaemia. A total of 52% (n = 78) patients developed 114 complications with a level of 21.4% (n = 32) postoperative wound infections. The findings from this audit highlight the importance of regular blood glucose testing to enable early detection of hyperglycaemia and timely initiation of appropriate treatments regimes for diabetic patients undergoing cardiac surgery. Findings also show that hyperglycaemia derangement may make a difference in the recovery phase. While patients will benefit from lesser wound infections, hospitals might save costs involved with treating postoperative complications. More consistent blood glucose testing might be achieved through the use of evidence-based protocols. However, the education of staff is as important as it develops knowledge on the complex metabolic interactions of diabetic patients undergoing cardiac surgery. While this means investing in staff education and policy development, costs for daily care and expensive treatments for complications will be saved as patient recovery will be speedier and less eventful.

Carbon dioxide field flooding reduces neurologic impairment after open heart surgery.

PubMed

Martens, Sven; Neumann, Katrin; Sodemann, Christian; Deschka, Heinz; Wimmer-Greinecker, Gerhard; Moritz, Anton

2008-02-01

Air emboli released from incompletely deaired cardiac chambers may cause neurocognitive decline after open heart surgery. Carbon dioxide (CO2) field flooding is reported to reduce residual intracavital air during cardiac surgery. A protective effect of carbon dioxide insufflation on postoperative brain function remains unproven in clinical trials. Eighty patients undergoing heart valve operations by median sternotomy were randomly assigned to either CO2 insufflation (group I, n = 39) or unprotected controls (group II, n = 41). Preoperative evaluation included neurocognitive test batteries consisting of six different tests, and objective measurements of brain function by means of P300 wave auditory-evoked potentials (peak latencies, ms). Neurocognitive testing and P300 measurements were repeated on postoperative day 5. Neurocognitive deficit (ND) was defined as a 20% decrement in two or more tests. Preoperatively, P300 peak latencies did not differ between groups (374 +/- 75 vs 366 +/- 72 ms, not significant [n.s.]). Five days after surgery, P300 peak latencies were significantly shorter with CO2 protection as compared with the unprotected control group (group I: 390 +/- 68 ms, group II: 429 +/- 75 ms, p = 0.02). Clinical outcome was comparable as for mortality (group I: 1 patient; group II: 2 patients) and cerebrovascular events or confusional syndromes (group I: 5 patients; group II: 4 patients) or other clinical variables as intubation time or hospital stay. Neurocognitive test batteries did not reveal differences between groups. Shorter P300 peak latencies after surgery indicate less brain damage in patients who underwent heart valve operations with CO2 flooding of the thoracic cavity. Even if these findings were not supported by clinical results or neurocognitive test batteries in our cohort, carbon dioxide field flooding has proven efficiency and should be advocated for all patients undergoing open heart surgery.

Diagnostic and Prognostic Significance of DSM-5 Attenuated Psychosis Syndrome in Services for Individuals at Ultra High Risk for Psychosis.

PubMed

Fusar-Poli, Paolo; De Micheli, Andrea; Cappucciati, Marco; Rutigliano, Grazia; Davies, Cathy; Ramella-Cravaro, Valentina; Oliver, Dominic; Bonoldi, Ilaria; Rocchetti, Matteo; Gavaghan, Lauren; Patel, Rashmi; McGuire, Philip

2018-02-15

The diagnostic and prognostic significance of the DSM-5-defined Attenuated Psychosis Syndrome (DSM-5-APS) in individuals undergoing an ultra high risk (UHR) clinical assessment for suspicion of psychosis risk is unknown. Prospective cohort study including all consecutive help-seeking individuals undergoing both a DSM-5-APS and a Comprehensive Assessment of At Risk Mental States (CAARMS 12/2006) assessment for psychosis risk at the Outreach and Support in South London (OASIS) UHR service (March 2013-April 2014). The diagnostic significance of DSM-5-APS was assessed with percent overall agreement, prevalence bias adjusted kappa, Bowker's test, Stuart-Maxwell test, residual analysis; the prognostic significance with Cox regression, Kaplan-Meier failure function, time-dependent area under the curve (AUC) and net benefits analysis. The impact of specific revisions of the DSM-5-APS was further tested. In 203 help-seeking individuals undergoing UHR assessment, the agreement between the DSM-5-APS and the CAARMS 12/2006 was only moderate (kappa 0.59). Among 142 nonpsychotic cases, those meeting DSM-5-APS criteria had a 5-fold probability (HR = 5.379) of developing psychosis compared to those not meeting DSM-5-APS criteria, with a 21-month cumulative risk of psychosis of 28.17% vs 6.49%, respectively. The DSM-5-APS prognostic accuracy was acceptable (AUC 0.76 at 24 months) and similar to the CAARMS 12/2006. The DSM-5-APS designation may be clinically useful to guide the provision of indicated interventions within a 7%-35% (2-year) range of psychosis risk. The removal of the criterion E or C of the DSM-5-APS may improve its prognostic performance and transdiagnostic value. The DSM-5-APS designation may be clinically useful in individuals accessing clinical services for psychosis prevention. © The Author 2017. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com

Understanding of multigene test results among males undergoing germline testing for inherited prostate cancer: Implications for genetic counseling.

PubMed

Giri, Veda N; Obeid, Elias; Hegarty, Sarah E; Gross, Laura; Bealin, Lisa; Hyatt, Colette; Fang, Carolyn Y; Leader, Amy

2018-04-14

Genetic testing (GT) for prostate cancer (PCA) is rising, with limited insights regarding genetic counseling (GC) needs of males. Genetic Evaluation of Men (GEM) is a prospective multigene testing study for inherited PCA. Men undergoing GC were surveyed on knowledge of cancer risk and genetics (CRG) and understanding of personal GT results to identify GC needs. GEM participants with or high-risk for PCA were recruited. Pre-test GC was in-person, with video and handout, or via telehealth. Post-test disclosure was in-person, by phone, or via telehealth. Clinical and family history data were obtained from participant surveys and medical records. Participants completed measures of knowledge of CRG, literacy, and numeracy pre-test and post-test. Understanding of personal genetic results was assessed post-test. Factors associated with knowledge of CRG and understanding of personal genetic results were examined using multivariable linear regression or McNemar's test. Among 109 men who completed pre- and post-GT surveys, multivariable analysis revealed family history meeting hereditary cancer syndrome (HCS) criteria was significantly predictive of higher baseline knowledge (P = 0.040). Of 101 men who responded definitively regarding understanding of results, 13 incorrectly reported their result (McNemar's P < 0.001). Factors significantly associated with discordance between reported and actual results included having a variant of uncertain significance (VUS) (P < 0.001) and undergoing GC via pre-test video and post-test phone disclosure (P = 0.015). While meeting criteria for HCS was associated with higher knowledge of CRG, understanding of personal GT results was lacking among a subset of males with VUS. A more exploratory finding was lack of understanding of results among men who underwent GC utilizing video and phone. Studies optimizing GC strategies for males undergoing multigene testing for inherited PCA are warranted. © 2018 Wiley Periodicals, Inc.

Evidence that personal genome testing enhances student learning in a course on genomics and personalized medicine.

PubMed

Salari, Keyan; Karczewski, Konrad J; Hudgins, Louanne; Ormond, Kelly E

2013-01-01

An emerging debate in academic medical centers is not about the need for providing trainees with fundamental education on genomics, but rather the most effective educational models that should be deployed. At Stanford School of Medicine, a novel hands-on genomics course was developed in 2010 that provided students the option to undergo personal genome testing as part of the course curriculum. We hypothesized that use of personal genome testing in the classroom would enhance the learning experience of students. No data currently exist on how such methods impact student learning; thus, we surveyed students before and after the course to determine its impact. We analyzed responses using paired statistics from the 31 medical and graduate students who completed both pre-course and post-course surveys. Participants were stratified by those who did (N = 23) or did not (N = 8) undergo personal genome testing. In reflecting on the experience, 83% of students who underwent testing stated that they were pleased with their decision compared to 12.5% of students who decided against testing (P = 0.00058). Seventy percent of those who underwent personal genome testing self-reported a better understanding of human genetics on the basis of having undergone testing. Further, students who underwent personal genome testing demonstrated an average 31% increase in pre- to post-course scores on knowledge questions (P = 3.5×10(-6)); this was significantly higher (P = 0.003) than students who did not undergo testing, who showed a non-significant improvement. Undergoing personal genome testing and using personal genotype data in the classroom enhanced students' self-reported and assessed knowledge of genomics, and did not appear to cause significant anxiety. At least for self-selected students, the incorporation of personal genome testing can be an effective educational tool to teach important concepts of clinical genomic testing.

Clinical Utility and Pitfalls of Ultrasound Guided Foreign Body Removal in War Fighters

DTIC Science & Technology

2013-10-01

training, with pre-test and post-test components. Physicians will undergo pre-testing with the removal of one wooden foreign body from a turkey breast ...project. The physicians are trained with a turkey breast simulator. They will be evaluated and measured on their performance and competency development...foreign bodies were the same. A 1 cm piece of a wooden toothpick was used to represent a traditional foreign body implanted in the cadaver tissue

Predictors of Breast Cancer Screening in Asian and Latina University Students

ERIC Educational Resources Information Center

Regan, Pamela C.; Durvasula, Ramani S.

2008-01-01

Preventative screening in the form of clinical breast examinations remains among the best protections against breast cancer. Despite the benefits that regular examinations confer, many women fail to obtain screening tests. Because ethnic minority women are particularly unlikely to undergo regular screening, and experience increased mortality and…

Participation of low-income women in genetic cancer risk assessment and BRCA 1/2 testing: the experience of a safety-net institution.

PubMed

Komenaka, Ian K; Nodora, Jesse N; Madlensky, Lisa; Winton, Lisa M; Heberer, Meredith A; Schwab, Richard B; Weitzel, Jeffrey N; Martinez, Maria Elena

2016-07-01

Some communities and populations lack access to genetic cancer risk assessment (GCRA) and testing. This is particularly evident in safety-net institutions, which serve a large segment of low-income, uninsured individuals. We describe the experience of a safety-net clinic with limited resources in providing GCRA and BRCA1/2 testing. We compared the proportion and characteristics of high-risk women who were offered and underwent GCRA and genetic testing. We also provide a description of the mutation profile for affected women. All 125 patients who were offered GCRA accepted to undergo GCRA. Of these, 72 % had a breast cancer diagnosis, 70 % were Hispanic, 52.8 % were non-English speakers, and 66 % did not have health insurance. Eighty four (67 %) were offered genetic testing and 81 (96 %) agreed. Hispanic women, those with no medical insurance, and those with a family history of breast cancer were significantly more likely to undergo testing (p > 0.01). Twelve of 81 (15 %) patients were found to have deleterious mutations, seven BRCA1, and five BRCA2. Our experience shows that it is possible to offer GCRA and genetic testing even in the setting of limited resources for these services. This is important given that a large majority of the low-income women in our study agreed to undergo counseling and testing. Our experience could serve as a model for similar low-resource safety-net health settings.

USE OF THE PROSTATE HEALTH INDEX FOR DETECTION OF PROSTATE CANCER: RESULTS FROM A LARGE ACADEMIC PRACTICE

PubMed Central

Tosoian, Jeffrey J.; Druskin, Sasha C.; Andreas, Darian; Mullane, Patrick; Chappidi, Meera; Joo, Sarah; Ghabili, Kamyar; Agostino, Joseph; Macura, Katarzyna J.; Carter, H. Ballentine; Schaeffer, Edward M.; Partin, Alan W.; Sokoll, Lori J.; Ross, Ashley E.

2016-01-01

BACKGROUND The Prostate Health Index (phi) outperforms PSA and other PSA derivatives for the diagnosis of prostate cancer (PCa). The impact of phi testing in the real-world clinical setting has not been previously assessed. METHODS In a single, large, academic center, phi was tested in 345 patients presenting for diagnostic evaluation for PCa. Findings on prostate biopsy (including Grade Group [GG], defined as GG1: Gleason score [GS] 6, GG2: GS 3+4=7, GG3: GS 4+3=7, GG4: GS 8, and GG5: GS 9-10), magnetic resonance imaging (MRI), and radical prostatectomy (RP) were prospectively recorded. Biopsy rates and outcomes were compared to a contemporary cohort that did not undergo phi testing (n=1318). RESULTS Overall, 39% of men with phi testing underwent prostate biopsy. No men with phi<19.6 were diagnosed with PCa, and only 3 men with phi<27 had cancer of GG≥2. Phi was superior to PSA for the prediction of any PCa (AUC 0.72 vs. 0.47) and GG≥2 PCa (AUC 0.77 vs. 0.53) on prostate biopsy. Among men undergoing MRI and phi, no men with phi<27 and PI-RADS≤3 had GG≥2 cancer. For those men proceeding to RP, increasing phi was associated with higher pathologic GG (p=0.002) and stage (p=0.001). Compared to patients who did not undergo phi testing, the use of phi was associated with a 9% reduction in the rate of prostate biopsy (39% vs. 48%; p<0.001). Importantly, the reduction in biopsy among the phi population was secondary to decreased incidence of negative (8%) and GG1 (1%) biopsies, while the proportion of biopsies detecting GG≥2 cancers remained unchanged. CONCLUSIONS In this large, real-time clinical experience, phi outperformed PSA alone, was associated with high-grade PCa, and provided complementary information to MRI. Incorporation of phi into clinical practice reduced the rate of unnecessary biopsies without changing the frequency of detection of higher grade cancers. PMID:28117387

Incidence of Pneumothorax in Patients With Lymphangioleiomyomatosis Undergoing Pulmonary Function and Exercise Testing.

PubMed

Taveira-DaSilva, Angelo M; Julien-Williams, Patricia; Jones, Amanda M; Moss, Joel

2016-07-01

Because pneumothorax is frequent in lymphangioleiomyomatosis, patients have expressed concerns regarding the risk of pneumothorax associated with pulmonary function or exercise testing. Indeed, pneumothorax has been reported in patients with lung disease after both of these tests. The aim of this study was to determine the incidence of pneumothorax in patients with lymphangioleiomyomatosis during admissions to the National Institutes of Health Clinical Research Center between 1995 and 2015. Medical records were reviewed to identify patients who had a pneumothorax during their stay at the National Institutes of Health. A total of 691 patients underwent 4,523 pulmonary function tests and 1,900 exercise tests. Three patients developed pneumothorax after pulmonary function tests and/or exercise tests. The incidence of pneumothorax associated with lung function testing was 0.14 to 0.29 of 100 patients or 0.02 to 0.04 of 100 tests. The incidence of pneumothorax in patients undergoing exercise testing was 0.14 to 0.28 of 100 patients or 0.05 to 0.10 of 100 tests. The risk of pneumothorax associated with pulmonary function or exercise testing in patients with lymphangioleiomyomatosis is low. Published by Elsevier Inc.

The Comprehensive Soldier and Family Fitness Program Evaluation. Report 4. Evaluation of Resilience Training and Mental and Behavioral Health Outcomes

DTIC Science & Technology

2013-04-01

Corporation. Meyer, G. J., Finn, S. E., Eyde , L. D., Kay, G. G., Moreland, K. L., Dies, R. R.,…Reed, G. M. (2001). Psychological testing and...reduce Naval basic training attrition rates by improving psychological functioning. BOOT STRAP was tested among recruits undergoing a stressful...and Clinical Psychology , 23, 603-619. Pituch, K. A., Whittaker, T. A., & Stapleton, L. M. (2005). A comparison of methods to test for mediation

Use of thromboelastography to tailor dual-antiplatelet therapy in patients undergoing treatment of intracranial aneurysms with the Pipeline embolization device.

PubMed

McTaggart, Ryan A; Choudhri, Omar A; Marcellus, Mary L; Brennan, Tom; Steinberg, Gary K; Dodd, Robert L; Do, Huy M; Marks, Michael P

2015-06-01

Platelet function testing is controversial and not well studied in patients with neurovascular disease. To evaluate the performance of thromboelastography (TEG) as a platelet function test in neurovascular patients treated with the Pipeline embolization device (PED). A prospective protocol was instituted for platelet function testing in patients undergoing repair of intracranial aneurysms with the PED. All patients received dual antiplatelet therapy (DAT) and their response to both P2Y12 inhibitors and aspirin was quantified with TEG. Each patient's DAT induction strategy was tailored based on the percentage ADP-induced and percentage arachidonic acid-induced platelet inhibition reported by TEG. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Patients were followed up clinically and/or angiographically at 30 days, 6 months, and 1 year. Thirty-four PED procedures were performed on 31 patients. TEG results altered the DAT strategy in 35% of patients. Technical success with the Pipeline placement was 100%. Two patients had minor strokes and five had transient ischemic attacks (TIAs). There have been no hemorrhagic complications. No patient had permanent neurologic deficits. Six of eight (75%) of patients with thromboembolic/TIA events were ADP-induced hyporesponders by TEG. Our 6- and 12-month angiographic occlusion rates were 78.9% and 89.5%, respectively. The 19 major branches covered by the PED that were assessed by follow-up imaging have all remained patent. Platelet function testing with TEG altered our DAT induction strategy in a significant number of cases. No hemorrhagic or disabling thromboembolic complications were seen in this series. Future studies should compare methods of platelet function testing and, possibly, no platelet function testing in neurovascular patients undergoing flow diversion and/or stent-assisted treatment of intracranial aneurysms. 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.

HIV testing and clinical status upon admission to a specialized health care unit in Pará, Brazil

PubMed Central

Abati, Paulo Afonso Martins; Segurado, Aluisio Cotrim

2015-01-01

OBJECTIVE To analyze the clinical and laboratory characteristics of HIV-infected individuals upon admission to a reference health care center. METHODS This cross-sectional study was conducted between 1999 and 2010 on 527 individuals with confirmed serological diagnosis of HIV infection who were enrolled in an outpatient health care service in Santarém, PA, Northern Brazil. Data were collected from medical records and included the reason for HIV testing, clinical status, and count of peripheral CD4+ T lymphocytes upon enrollment. The data were divided into three groups, according to the patient’s year of admission – P1 (1999-2002), P2 (2003-2006), and P3 (2007-2010) – for comparative analysis of the variables of interest. RESULTS In the study group, 62.0% of the patients were assigned to the P3 group. The reason for undergoing HIV testing differed between genders. In the male population, most tests were conducted because of the presence of symptoms suggesting infection. Among women, tests were the result of knowledge of the partner’s seropositive status in groups P1 and P2. Higher proportion of women undergoing testing because of symptoms of HIV/AIDS infection abolished the difference between genders in the most recent period. A higher percentage of patients enrolling at a more advanced stage of the disease was observed in P3. CONCLUSIONS Despite the increased awareness of the number of HIV/AIDS cases, these patients have identified their serological status late and were admitted to health care units with active disease. The HIV/AIDS epidemic in Pará presents specificities in its progression that indicate the complex characteristics of the epidemic in the Northern region of Brazil and across the country. PMID:25741647

HIV testing and clinical status upon admission to a specialized health care unit in Pará, Brazil.

PubMed

Abati, Paulo Afonso Martins; Segurado, Aluisio Cotrim

2015-01-01

OBJECTIVE To analyze the clinical and laboratory characteristics of HIV-infected individuals upon admission to a reference health care center. METHODS This cross-sectional study was conducted between 1999 and 2010 on 527 individuals with confirmed serological diagnosis of HIV infection who were enrolled in an outpatient health care service in Santarém, PA, Northern Brazil. Data were collected from medical records and included the reason for HIV testing, clinical status, and count of peripheral CD4+ T lymphocytes upon enrollment. The data were divided into three groups, according to the patient's year of admission - P1 (1999-2002), P2 (2003-2006), and P3 (2007-2010) - for comparative analysis of the variables of interest. RESULTS In the study group, 62.0% of the patients were assigned to the P3 group. The reason for undergoing HIV testing differed between genders. In the male population, most tests were conducted because of the presence of symptoms suggesting infection. Among women, tests were the result of knowledge of the partner's seropositive status in groups P1 and P2. Higher proportion of women undergoing testing because of symptoms of HIV/AIDS infection abolished the difference between genders in the most recent period. A higher percentage of patients enrolling at a more advanced stage of the disease was observed in P3. CONCLUSIONS Despite the increased awareness of the number of HIV/AIDS cases, these patients have identified their serological status late and were admitted to health care units with active disease. The HIV/AIDS epidemic in Pará presents specificities in its progression that indicate the complex characteristics of the epidemic in the Northern region of Brazil and across the country.

Factors That Influence Surgical Margin State in Patients Undergoing Cold Knife Conization - A Single Center Experience.

PubMed

Aluloski, Igor; Tanturovski, Mile; Petrusevska, Gordana; Jovanovic, Rubens; Kostadinova-Kunovska, Slavica

2017-12-01

To evaluate the factors that influence the surgical margin state in patients undergoing cold knife conization at the University Clinic of Gynecology and Obstetrics in Skopje, Republic of Macedonia Materials and methods: We have retrospectively analyzed the medical records of all patients that underwent a cold knife conization at our Clinic in 2015. We cross-referenced the surgical margin state with the histopathological diagnosis (LSIL, HSIL or micro-invasive/invasive cancer), menopausal status of the patients, number of pregnancies, surgeon experience, operating time and cone depth. The data was analyzed with the Chi square test, Fisher's exact test for categorical data and Student's T test for continuous data and univariate and multivariate logistical regressions were performed. A total of 246 medical records have neen analyzed, out of which 29 (11.79%) patients had LSIL, 194 (78.86%) had HSIL and 23 (9.34%) patients suffered micro-invasive/invasive cervical cancer. The surgical margins were positive in 78 (31.7%) of the patients. The average age of the patients was 41.13 and 35 (14.23%) of the patients were menopausal. The multivariate logistic regression identified preoperative forceps biopsy of micro-invasive SCC, HSIL or higher cone specimen histology and shorter cone depth as independent predictors of surgical margin involvement in patients undergoing cold knife conization. In the current study, we have found no association between the inherent characteristics of the patient and the surgeon and the surgical margin state after a CKC. The most important predictors for positive margins were the severity of the lesion and the cone depth.

A non-pregnant woman with elevated beta-HCG: A case of para-neoplastic syndrome in ovarian cancer.

PubMed

Goldstein, Jennifer; Pandey, Prasamsa; Fleming, Nicole; Westin, Shannon; Piha-Paul, Sarina

2016-08-01

There is a broad range of possible diagnoses for an elevated beta human chorionic gonadotropin (β-hCG) in the absence of intrauterine or ectopic pregnancy. When women of child bearing potential undergo evaluation for clinical trial, it is often unclear what course of evaluation to take when a pregnancy test is positive. We describe the clinical course of a patient with widely metastatic mucinous ovarian carcinoma with metastasis to the peritoneum, lymph nodes and liver. The patient was found to have a mildly elevated β-hCG during initial evaluation for clinical trial. Extensive work up for ectopic pregnancy, trophoblastic disease, and phantom β-hCG were negative. The patient's β-hCG levels continued to rise until initiation of therapy. She was treated on a phase I protocol with restaging scans revealing a partial response. The β-hCG was retested and declined in conjunction with her response, consistent with paraneoplastic β-hCG. Here, we propose a decision making algorithm to evaluate a patient with an elevated β-hCG undergoing assessment for clinical trial.

Randomized trial of harp therapy during in vitro fertilization-embryo transfer.

PubMed

Murphy, Erin M; Nichols, Jennifer; Somkuti, Steve G; Sobel, Michael; Braverman, Andrea; Barmat, Larry I

2014-04-01

This study evaluated whether harp therapy reduces levels of stress and improves clinical outcomes in patients undergoing embryo transfer. This prospective randomized trial enrolled 181 women undergoing embryo transfer, who were randomized to harp therapy during embryo transfer or standard treatment. Patients underwent standardized psychological testing and physiologic assessment of stress. The study was conducted in a reproductive medicine practice. No statistically significant differences were found in the heart and respiratory rates, nor was there a significant difference in event-based anxiety at baseline. Harp therapy had a significantly larger decrease in state anxiety from pre- to post-embryo transfer. Clinical pregnancy was 53% versus 48% for the harp therapy and standard treatment groups, respectively. Harp therapy decreases state, or event-based, anxiety, significantly lowering state scores posttransfer and having a positive effect on acute levels of stress. There was an increased pregnancy rate, but larger sample sizes are needed to evaluate whether harp therapy has an effect on clinical outcomes.

International Technology Transfer of a GCLP-Compliant HIV-1 Neutralizing Antibody Assay for Human Clinical Trials

PubMed Central

Todd, Christopher A.; Greene, Kelli M.; Montefiori, David C.; Sarzotti-Kelsoe, Marcella

2012-01-01

The Collaboration for AIDS Vaccine Discovery/Comprehensive Antibody – Vaccine Immune Monitoring Consortium (CAVD/CA-VIMC) assisted an international network of laboratories in transferring a validated assay used to judge HIV-1 vaccine immunogenicity in compliance with Good Clinical Laboratory Practice (GCLP) with the goal of adding quality to the conduct of endpoint assays for Human Immunodeficiency Virus I (HIV-1) vaccine human clinical trials. Eight Regional Laboratories in the international setting (Regional Laboratories), many located in regions where the HIV-1 epidemic is most prominent, were selected to implement the standardized, GCLP-compliant Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells (TZM-bl NAb Assay). Each laboratory was required to undergo initial training and implementation of the immunologic assay on-site and then perform partial assay re-validation, competency testing, and undergo formal external audits for GCLP compliance. Furthermore, using a newly established external proficiency testing program for the TZM-bl NAb Assay has allowed the Regional Laboratories to assess the comparability of assay results at their site with the results of neutralizing antibody assays performed around the world. As a result, several of the CAVD/CA-VIMC Regional Laboratories are now in the process of conducting or planning to conduct the GCLP-compliant TZM-bl NAb Assay as an indicator of vaccine immunogenicity for ongoing human clinical trials. PMID:22303476

International technology transfer of a GCLP-compliant HIV-1 neutralizing antibody assay for human clinical trials.

PubMed

Ozaki, Daniel A; Gao, Hongmei; Todd, Christopher A; Greene, Kelli M; Montefiori, David C; Sarzotti-Kelsoe, Marcella

2012-01-01

The Collaboration for AIDS Vaccine Discovery/Comprehensive Antibody-Vaccine Immune Monitoring Consortium (CAVD/CA-VIMC) assisted an international network of laboratories in transferring a validated assay used to judge HIV-1 vaccine immunogenicity in compliance with Good Clinical Laboratory Practice (GCLP) with the goal of adding quality to the conduct of endpoint assays for Human Immunodeficiency Virus I (HIV-1) vaccine human clinical trials. Eight Regional Laboratories in the international setting (Regional Laboratories), many located in regions where the HIV-1 epidemic is most prominent, were selected to implement the standardized, GCLP-compliant Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells (TZM-bl NAb Assay). Each laboratory was required to undergo initial training and implementation of the immunologic assay on-site and then perform partial assay re-validation, competency testing, and undergo formal external audits for GCLP compliance. Furthermore, using a newly established external proficiency testing program for the TZM-bl NAb Assay has allowed the Regional Laboratories to assess the comparability of assay results at their site with the results of neutralizing antibody assays performed around the world. As a result, several of the CAVD/CA-VIMC Regional Laboratories are now in the process of conducting or planning to conduct the GCLP-compliant TZM-bl NAb Assay as an indicator of vaccine immunogenicity for ongoing human clinical trials.

Short term clinical effectiveness of a 0.07% cetylpyridinium chloride mouth rinse in patients undergoing fixed orthodontic appliance treatment.

PubMed

Pahwa, Narinder; Kumar, Atul; Gupta, Siddharth

2011-07-01

To test the short term clinical effectiveness of commercially available 0.07%.cetylpyridinium chloride mouth rinse in patients undergoing fixed orthodontic treatment as compared to a placebo mouth rinse and patients using toothbrush and toothpaste. Forty-five subjects for this double blind study were assigned randomly into three groups of 15 each. Gingival inflammation, plaque accumulation, and bleeding on probing, were recorded at baseline (10 days after prophylaxis), and at the end of one month in all the three groups and compared. Paired t test showed significant differences in bleeding index for pre and post treatment recordings for cetylpyridinium group. Modified gingival index showed no significant difference in the cetylpyridinium group. For plaque index significant difference was found for cetylpyridinium and control groups. Cetylpyridinium mouth rinse 0.7% was found to be effective in reducing the bleeding and plaque index scores. It was not effective in reducing the modified gingival index scores. Cetylpyridinium mouth rinse 0.07% improves the oral hygiene of orthodontic patients when used as an adjunct to normal oral hygiene measures.

Hospital-Acquired Pneumonia in Patients Undergoing Coronary Artery Bypass Graft; Comparison of the Center for Disease Control Clinical Criteria With Physicians’ Judgment

PubMed Central

Baghban, Mahboubeh; Paknejad, Omalbanin; Yousefshahi, Fardin; Gohari Moghadam, Keivan; Bina, Payvand; Samimi Sadeh, Saghar

2014-01-01

Background: Following coronary artery bypass graft (CABG), patients are at high risk (3.2%-8.3%) for developing hospital-acquired pneumonia (HAP) with mortality rate of 24% to 50%. Some of routine features in patients undergoing CABG are similar to clinical criteria of Center of Disease Control (CDC) for diagnosis of pneumonia. This may lead to over-diagnosis of pneumonia in these patients. Objectives: This study aimed to assess the frequency of CDC criteria for diagnosis of pneumonia in patients undergoing CABG. Patients and Methods: This study was performed on CABG candidates admitted to post cardiac surgery Intensive Care Unit (ICU) in a six-month period. Patient’s records, Chest-X-Ray, and Laboratory tests were assessed for PNU1-CDC criteria for HAP diagnosis. At the same time, a physician who was unaware of the study protocol assessed the clinical diagnosis. Then the results were compared with CDC criteria-based diagnosis. Results: Of total 300 patients, 9 (3%) met CDC criteria for diagnosis of pneumonia while none of the cases were diagnosed as HAP according to the physicians’ clinical diagnosis. All nine patients were discharged with proper general condition and no need of antibiotic therapy. This study showed that loss of consciousness, tachypnea, dyspnea, PaO2 < 60 mm Hg, PaO2/FiO2 < 240, and local infiltration in 24 hours of operation were misleading features of CDC criteria, which were not considered in physicians’ clinical judgment to establish the diagnosis. Conclusions: Our findings suggest that in Post-CABG patients, physicians could judge the occurrence of HAP more accurately in comparison to making the diagnosis based on CDC criteria alone. Expert physician may intentionally do not take some of these criteria into account according the patients’ course of disease. Therefore, it is suggested that the value of these criteria in special group of patients like those undergoing CABG should be re-evaluated. PMID:25289379

Hospital-acquired pneumonia in patients undergoing coronary artery bypass graft; comparison of the center for disease control clinical criteria with physicians' judgment.

PubMed

Baghban, Mahboubeh; Paknejad, Omalbanin; Yousefshahi, Fardin; Gohari Moghadam, Keivan; Bina, Payvand; Samimi Sadeh, Saghar

2014-08-01

Following coronary artery bypass graft (CABG), patients are at high risk (3.2%-8.3%) for developing hospital-acquired pneumonia (HAP) with mortality rate of 24% to 50%. Some of routine features in patients undergoing CABG are similar to clinical criteria of Center of Disease Control (CDC) for diagnosis of pneumonia. This may lead to over-diagnosis of pneumonia in these patients. This study aimed to assess the frequency of CDC criteria for diagnosis of pneumonia in patients undergoing CABG. This study was performed on CABG candidates admitted to post cardiac surgery Intensive Care Unit (ICU) in a six-month period. Patient's records, Chest-X-Ray, and Laboratory tests were assessed for PNU1-CDC criteria for HAP diagnosis. At the same time, a physician who was unaware of the study protocol assessed the clinical diagnosis. Then the results were compared with CDC criteria-based diagnosis. Of total 300 patients, 9 (3%) met CDC criteria for diagnosis of pneumonia while none of the cases were diagnosed as HAP according to the physicians' clinical diagnosis. All nine patients were discharged with proper general condition and no need of antibiotic therapy. This study showed that loss of consciousness, tachypnea, dyspnea, PaO2 < 60 mm Hg, PaO2/FiO2 < 240, and local infiltration in 24 hours of operation were misleading features of CDC criteria, which were not considered in physicians' clinical judgment to establish the diagnosis. Our findings suggest that in Post-CABG patients, physicians could judge the occurrence of HAP more accurately in comparison to making the diagnosis based on CDC criteria alone. Expert physician may intentionally do not take some of these criteria into account according the patients' course of disease. Therefore, it is suggested that the value of these criteria in special group of patients like those undergoing CABG should be re-evaluated.

Clinical and radiographic evaluation of maxillary central incisors exposure in patients undergoing maxillary advancement

PubMed Central

Trento, Guilherme dos Santos; Bernabé, Felipe Bueno Rosettti; da Costa, Delson João; Rebellato, Nelson Luis Barbosa; Klüppel, Leandro Eduardo; Scariot, Rafaela

2015-01-01

Abstract Introduction: Patients with dentofacial deformities may undergo orthodontic or orthodontic-surgical treatment. Both modalities can affect esthetics. Objective: This study aims to evaluate clinical and radiographic changes in exposure of maxillary central incisors occurring after orthognathic surgery for maxillary advancement. Methods: A total of 17 patients who underwent orthognathic surgery for maxillary advancement between September, 2010 and July, 2011 were selected. Exposure of maxillary central incisors was evaluated clinically and by lateral cephalograms. Measurements were taken one week before and three months after surgery. Data were paired in terms of sex, age, nasolabial angle, height and thickness of the upper lip, the amount of maxillary advancement, clinical exposure and inclination of maxillary central incisor by statistical tests (CI 95%). Results: After maxillary advancement, incisor clinical exposure had increased even with relaxed lips and under forced smile. Moreover, there was a mean increase of 23.33% revealed by lateral cephalograms. There was an inverse correlation between upper lip thickness and incisors postsurgical exposure revealed by radiographic images (p = 0.002). Conclusions: Significant changes in the exposure of maxillary central incisors occur after maxillary advancement, under the influence of some factors, especially lip thickness. PMID:26691970

Clinical feasibility of pre-operative neurodevelopmental assessment of infants undergoing open heart surgery.

PubMed

Campbell, Miranda; Rabbidge, Bridgette; Ziviani, Jenny; Sakzewski, Leanne

2017-08-01

Assessing the neurodevelopmental status of infants with congenital heart disease before surgery provides a means of identifying those at heightened risk of developmental delay. This study aimed to investigate factors impacting clinical feasibility of pre-operative neurodevelopmental assessment of infants undergoing early open heart surgery. Infants who underwent open heart surgery prior to 4 months of age participated in this cross-sectional study. The Test of Infant Motor Performance and Prechtl's Assessment of General Movements were undertaken on infants pre-operatively. When assessments could not be undertaken, reasons were ascribed to either infant or environmental circumstances. Demographic data and Aristotle scores were compared between groups of infants who did or did not undergo assessment. Binary logistic regression was used to explore associations. A total of 60 infants participated in the study. Median gestational age was 38.78 weeks (interquartile range: 36.93-39.72). Of these infants, 37 (62%) were unable to undergo pre-operative assessment. Twenty-four (40%) could not complete assessment due to infant-related factors and 13 (22%) due to environmental-related factors. For every point increase in the Aristotle Patient-Adjusted Complexity score, the infants likelihood of being unable to undergo assessment increased by 35% (odds ratio: 0.35; 95% confidence interval: 1.03-1.77, P = 0.03). Over half of the infants undergoing open heart surgery were unable to complete pre-operative neurodevelopmental assessment. The primary reason for this was infant-related medical instability. Findings suggest further research is warranted to investigate whether the Aristotle Patient-Adjusted Complexity score might serve as an indicator to inform developmental surveillance with this medically fragile cohort. © 2017 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

Risk of radiation pneumonitis in patients receiving taxane-based trimodality therapy for locally advanced esophageal cancer.

PubMed

Shaikh, Talha; Churilla, Thomas M; Monpara, Pooja; Scott, Walter J; Cohen, Steven J; Meyer, Joshua E

There are limited data regarding clinical and treatment factors associated with radiation pneumonitis (RP) in patients receiving taxane-based trimodality therapy for esophageal cancer. The purpose of this study was to identify predictors of RP in patients undergoing trimodality therapy. We retrospectively reviewed patients undergoing chemoradiation followed by esophagectomy between 2006 and 2011. The association between clinical and dosimetric factors with RP was assessed using χ 2 test and Mann-Whitney U test. Multivariable regression was used to assess the relationship between grade 2+ RP and clinical/dosimetric factors. Receiver operator curves were generated to identify threshold doses for RP. A total of 139 patients were included; 19 (13.7%) patients experienced grade 2+ RP. Patients with upper/middle thoracic tumors (P = .038) and receiving higher radiation doses (P = .038) were more likely to develop grade 2+ RP. There was no association between taxane-based therapy and grade 2+ RP (P = .728). The percent volume of lung receiving 5 Gy (V5; P < .001), 10 Gy (P < .001), 20 Gy (V20; P < .001), and 30 Gy (P < .001) was associated with an increased risk of grade 2+ RP. On multivariable regression, the lung V5 (odds ratio, 1.101; 95% confidence interval, 1.1014-1.195) and V20 (odds ratio, 1.149; 95% confidence interval, 1.1015-1.301) remained associated with grade 2+ RP. A V5 ≤65% and V20 ≤25% were identified as optimal thresholds for increased grade 2+ RP. Dosimetric parameters are strong predictors of symptomatic RP in patients undergoing trimodality therapy for esophageal cancer. Mitigating the risk of RP in these patients should be an important consideration during treatment planning. Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Frozen embryo transfer prevents the detrimental effect of high estrogen on endometrium receptivity.

PubMed

Adeviye Erşahin, Aynur; Acet, Mustafa; Erşahin, Suat Süphan; Dokuzeylül Güngör, Nur

2017-03-15

To investigate whether serum levels of estradiol affect reproductive outcomes of normoresponder women undergoing fresh embryo transfer (ET) versus frozen-thawed ET (FET). Two hundred fifty-five normoresponder women underwent fresh ET in their first or second in vitro fertilization cycle. Ninety-two women with negative pregnacy test results underwent FET. Clinical and ongoing pregnancy rates, implantation, and live birth rates of women undergoing fresh ET versus FET were compared. One hundred forty-seven (57.65%) out of the 255 normoresponder women receiving FET had positive beta-human chorionic gonadotrophin (hCG) results. The remaining 108 women had negative beta-hCG results. The clinical pregnancy rates of the fresh ET group were found as 55.69% (n=142). Ninety-two of the 108 women with failed pregnancies underwent FET; 72.83% had positive beta-hCG results (n=67), and 70.65% had clinical pregnancy (n=65). Both biochemical and clinical pregnancy rates of women undergoing FET increased significantly (p<0.012 and p<0.013, respectively). Ongoing pregnancy (60.87% vs. 52.94%) and live birth rates (59.87% vs. 48.63%) were similar in both fresh and FET groups. Serum E2 levels of women who failed to conceive were significantly higher than those women did conceive. Serum progesterone levels of women who conceived versus those that did not were similar. The detrimental effect of high serum estradiol levels on endometrial receptivity could be prevented by FET.

Frozen embryo transfer prevents the detrimental effect of high estrogen on endometrium receptivity

PubMed Central

Erşahin, Aynur Adeviye; Acet, Mustafa; Erşahin, Suat Süphan; Dokuzeylül Güngör, Nur

2017-01-01

Objective: To investigate whether serum levels of estradiol affect reproductive outcomes of normoresponder women undergoing fresh embryo transfer (ET) versus frozen-thawed ET (FET). Material and Methods: Two hundred fifty-five normoresponder women underwent fresh ET in their first or second in vitro fertilization cycle. Ninety-two women with negative pregnacy test results underwent FET. Clinical and ongoing pregnancy rates, implantation, and live birth rates of women undergoing fresh ET versus FET were compared. Results: One hundred forty-seven (57.65%) out of the 255 normoresponder women receiving FET had positive beta-human chorionic gonadotrophin (hCG) results. The remaining 108 women had negative beta-hCG results. The clinical pregnancy rates of the fresh ET group were found as 55.69% (n=142). Ninety-two of the 108 women with failed pregnancies underwent FET; 72.83% had positive beta-hCG results (n=67), and 70.65% had clinical pregnancy (n=65). Both biochemical and clinical pregnancy rates of women undergoing FET increased significantly (p<0.012 and p<0.013, respectively). Ongoing pregnancy (60.87% vs. 52.94%) and live birth rates (59.87% vs. 48.63%) were similar in both fresh and FET groups. Serum E2 levels of women who failed to conceive were significantly higher than those women did conceive. Serum progesterone levels of women who conceived versus those that did not were similar. Conclusion: The detrimental effect of high serum estradiol levels on endometrial receptivity could be prevented by FET. PMID:28506949

An Inexpensive, Point-of-Care Urine Test for Bladder Cancer in Patients Undergoing Hematuria Evaluation.

PubMed

Acharya, Abhinav P; Theisen, Kathryn M; Correa, Andres; Meyyappan, Thiagarajan; Apfel, Abraham; Sun, Tao; Tarin, Tatum V; Little, Steven R

2017-11-01

Although hematuria (blood in urine) is the most common symptom of bladder cancer, 70-98% of hematuria cases are benign. These hematuria patients unnecessarily undergo costly, invasive, and expensive evaluation for bladder cancer. Therefore, there remains a need for noninvasive office-based tests that can rapidly and reliably rule out bladder cancer in patients undergoing hematuria evaluation. Herein, a clinical assay for matrix metalloproteinases ("Ammps") is presented, which generates a visual signal based on the collagenase activity (in urine of patients) on the Ammps substrates. Ammps substrates are generated by crosslinking gelatin with Fe(II) chelated alginate nanoparticles, which precipitate in urine samples. The cleavage of gelatin-conjugated alginate (Fe(II)) nanoparticles by collagenases generates free-floating alginate (Fe(II)) nanoparticles that participate in Fenton's reaction to generate a visual signal. In a pilot study of 88 patients, Ammps had 100% sensitivity, 85% specificity, and a negative predictive value (NPV) of 100% for diagnosing bladder cancer. This high NPV can be useful in ruling out bladder cancer in patients referred for hematuria evaluation. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Evaluation of the C6 Lyme Enzyme Immunoassay for the Diagnosis of Lyme Disease in Children and Adolescents.

PubMed

Lipsett, Susan C; Branda, John A; McAdam, Alexander J; Vernacchio, Louis; Gordon, Caroline D; Gordon, Catherine R; Nigrovic, Lise E

2016-10-01

The commercially-available C6 Lyme enzyme immunoassay (EIA) has been approved to replace the standard whole-cell sonicate EIA as a first-tier test for the diagnosis of Lyme disease and has been suggested as a stand-alone diagnostic. However, the C6 EIA has not been extensively studied in pediatric patients undergoing evaluation for Lyme disease. We collected discarded serum samples from children and adolescents (aged ≤21 years) undergoing conventional 2-tiered testing for Lyme disease at a single hospital-based clinical laboratory located in an area endemic for Lyme disease. We performed a C6 EIA on all collected specimens, followed by a supplemental immunoblot if the C6 EIA result was positive but the whole-cell sonicate EIA result was negative. We defined a case of Lyme disease as either a clinician-diagnosed erythema migrans lesion or a positive standard 2-tiered serologic result in a patient with symptoms compatible with Lyme disease. We then compared the performance of the C6 EIA alone and as a first-tier test followed by immunoblot, with that of standard 2-tiered serology for the diagnosis of Lyme disease. Of the 944 specimens collected, 114 (12%) were from patients with Lyme disease. The C6 EIA alone had sensitivity similar to that of standard 2-tiered testing (79.8% vs 81.6% for standard 2-tiered testing; P = .71) with slightly lower specificity (94.2% vs 98.8% 2; P < .002). Addition of a supplemental immunoblot improved the specificity of the C6 EIA to 98.6%. For children and adolescents undergoing evaluation for Lyme disease, the C6 EIA could guide initial clinical decision making, although a supplemental immunoblot should still be performed. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

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.

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.

Honey prevents oral mocositis in children undergoing chemotherapy: A quasi-experimental study with a control group.

PubMed

Kobya Bulut, Hacer; Güdücü Tüfekci, Fatma

2016-12-01

There are numerous pharmacological and non-pharmacological treatment options available in the treatment of oral mucositis. However, in spite of so many methods and products, medical professionals have not come to a consensus as to which of these offer the best results. This study was conducted to assess the effect of oral care with honey on children undergoing chemotherapy for the prevention and healing of oral mucositis. This quasi-experimental study was conducted on children undergoing chemotherapy. The study group consisted of 83 children who attended clinics and polyclinics for chemotherapy. All the children were included in the study period. The study was completed with a total of 76 children except for seven patients who were excluded from the study. The data were collected using a form and the World Health Organization Mucositis Assessment Index. The data were analyzed using percentage distributions, means, a chi-square test, a t-test, a variance analysis, and a Friedman test. Ethics approval of the study was obtained from the Institution Ethics Committee. It was found that the severity of oral mucositis in the children in the experimental group was significantly less than the control group. The mucositis recovery period in the experimental group was significantly shorter than the control group. Regular oral care with honey for children undergoing chemotherapy for hematological cancers prevents mucositis and also accelerates recovery of it when started after mucositis onset. Copyright © 2016. Published by Elsevier Ltd.

Clinical Validation of a miRNA Blood Test to Identify High-Risk Individuals Eligible for Low-Dose Computed Tomography Screening for Lung Cancer Early Detection

DTIC Science & Technology

2015-10-01

screening. The project requires the use of serum samples obtained from at-risk subjects (heavy smokers with defined characteristics) undergoing...screening. The project requires the use of serum samples obtained from at-risk subjects (heavy smokers with defined characteristics) that were collected

Language Deficits in Children with Psychiatric Disorders: Educational Implications.

ERIC Educational Resources Information Center

Lutz, Margaret M.

The study was designed to determine if there was an identifiable pattern of language deficit in 10 children (6 to 12 years old) undergoing treatment in a hospital inpatient psychiatry ward for behavioral and emotional problems. Ss were administered the standard hearing and speech clinic test battery which included the Binet Memory for Sentences,…

Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent: results in 18,671 consecutive studies.

PubMed

Kusnetzky, Lisa L; Khalid, Adnan; Khumri, Taiyeb M; Moe, Tabitha G; Jones, Philip G; Main, Michael L

2008-04-29

We sought to define acute mortality in hospitalized patients undergoing clinically indicated echocardiography with and without use of an ultrasound contrast agent. The U.S. Food and Drug Administration recently issued a boxed warning and new contraindications for the perflutren-containing ultrasound contrast agents following post-marketing reports of 4 patient deaths that were temporally related to Definity (Bristol-Myers Squibb Medical Imaging, Billerica, Massachusetts) administration. To appreciate the incremental risk of any medical procedure, the ambient risk of untoward outcome in the population in question must first be defined. There are no published data on short-term major adverse cardiac events in hospitalized patients undergoing echocardiography, either with or without administration of an ultrasound contrast agent. A retrospective analysis of hospitalized patients undergoing clinically indicated echocardiography between January 2005 and October 2007, within Saint Luke's Health System, Kansas City, Missouri, was performed. Studies were separated into 2 groups, those performed without contrast enhancement (n = 12,475) and those performed with Definity (n = 6,196). Vital status within 24 h of the echocardiographic study was available for all patients using a combination of the Social Security Death Master File and Saint Luke's Health System medical records. Incidence of death within 24 h was compared by chi-square test between Definity and unenhanced procedures. Of the 18,671 patient events, 72 patients died within 24 h. Of those that underwent unenhanced echocardiography, 46 died within 24 h (0.37%). Of patients receiving Definity during the echocardiogram, 26 died within 24 h (0.42%). There was no statistical difference between these 2 groups (p = 0.60). No patient died within 1 h of the echocardiographic study. In a random sampling from the unenhanced (n = 201) and Definity groups (n = 202), patients who underwent Definity-enhanced echocardiography exhibited higher clinical acuity, and more significant comorbidities. Approximately 0.4% of hospitalized patients die within 24 h of echocardiography. There is no increased mortality risk associated with Definity-enhanced examinations, despite evidence for higher clinical acuity and more comorbid conditions in patients undergoing contrast studies.

Infection, Alveolar Osteitis, and Adverse Effects Using Metronidazole in Healthy Patients Undergoing Third Molar Surgery: A Meta-analysis.

PubMed

Isiordia-Espinoza, Mario Alberto; Aragon-Martinez, Othoniel H; Bollogna-Molina, Ronell E; Alonso-Castro, Ángel J

2018-06-01

The aim of this systematic review and meta-analysis was to evaluate the risk of surgical infection, alveolar osteitis, and adverse effects using systemic metronidazole in comparison with placebo in healthy patients undergoing third molar surgery. The eligible reports were identified from diverse science sources. Clinical trials meeting the inclusion and exclusion criteria and an acceptable Oxford Quality Score were included in this study. The evaluation of risk was done using the Risk Reduction Calculator and Review Manager 5.3., from the Cochrane Library. A significant risk reduction was assumed when the upper limit of the 95% confidence intervals was <1 and the lower limit did not cross zero (negative number) alongside a p value of <0.05 for the overall test. Data of 667 patients from five clinical trials were used for the assessment of risk. Our analysis showed no reduction of the risk of infection or dry socket in patients receiving metronidazole compared to whom took placebo. Meanwhile, the adverse effects did not exhibit a difference between the studied groups. The routine use of systemic metronidazole to prevent surgical site infection and/or dry socket in healthy patients undergoing third molar surgery is not recommended.

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.

Towards improving diagnosis of memory loss in general practice: TIMeLi diagnostic test accuracy study protocol.

PubMed

Creavin, Sam T; Cullum, Sarah J; Haworth, Judy; Wye, Lesley; Bayer, Antony; Fish, Mark; Purdy, Sarah; Ben-Shlomo, Yoav

2016-07-19

People with cognitive problems, and their families, report distress and uncertainty whilst undergoing evaluation for dementia and perceive that traditional diagnostic evaluation in secondary care is insufficiently patient centred. The James Lind Alliance has prioritised research to investigate the role of primary care in supporting a more effective diagnostic pathway, and the topic is also of interest to health commissioners. However, there are very few studies that investigate the accuracy of diagnostic tests for dementia in primary care. We will conduct a prospective diagnostic test accuracy study to evaluate the accuracy of a range of simple tests for diagnosing all-cause-dementia in symptomatic people aged over 70 years who have consulted with their general practitioner (GP). We will invite eligible people to attend a research clinic where they will undergo a range of index tests that a GP could perform in the surgery and also be assessed by a specialist in memory disorders at the same appointment. Participating GPs will request neuroimaging and blood tests and otherwise manage patients in line with their usual clinical practice. The reference standard will be the consensus judgement of three experts (neurologist, psychiatrist and geriatrician) based on information from the specialist assessment, GP records and investigations, but not including items in the index test battery. The target condition will be all-cause dementia but we will also investigate diagnostic accuracy for sub-types where possible. We will use qualitative interviews with patients and focus groups with clinicians to help us understand the acceptability and feasibility of diagnosing dementia in primary care using the tests that we are investigating. Our results will help clinicians decide on which tests to perform in someone where there is concern about possible dementia and inform commissioning of diagnostic pathways.

Treatment and Prognosis of Isolated Local Relapse after Stereotactic Body Radiotherapy for Clinical Stage I Non-Small-Cell Lung Cancer: Importance of Salvage Surgery.

PubMed

Hamaji, Masatsugu; Chen, Fengshi; Matsuo, Yukinori; Ueki, Nami; Hiraoka, Masahiro; Date, Hiroshi

2015-11-01

Many efforts have been made to detect local relapse (LR) in the follow-up after stereotactic body radiotherapy (SBRT) for non-small-cell lung cancer (NSCLC) although limited data are available on its treatment and prognosis. We aimed to characterize treatment options and clarify long-term outcomes of isolated LR after SBRT for patients with clinical stage I NSCLC. We reviewed our institutional database in search of patients with isolated LR after SBRT for clinical stage I NSCLC at our institution between 1999 and 2013. Patient characteristics were compared with Mann-Whitney U test, χ2 test, or Fisher's exact test as appropriate. Survival outcomes were estimated with Kaplan-Meier method. Potential prognostic factors were investigated using Cox proportional hazard model. Of 308 patients undergoing SBRT for clinical stage I NSCLC, 49 patients were identified to have isolated LR. Twelve patients underwent salvage surgery, none underwent radiotherapy, and eight patients received chemotherapy, whereas 29 patients received best supportive care. No patient characteristic except operability was significantly related with patient selection for LR treatments. Five-year overall survival (OS) rate of the whole cohort was 47.9% from SBRT and 25.7% from LR. Salvage surgery was associated with improved OS after LR (p = 0.014), and 5-year OS for patients undergoing salvage surgery was 79.5% from LR. It was confirmed that our patient selection for salvage surgery for isolated LR was associated with favorable survival outcomes. Operability based on multidisciplinary conferences, rather than measurable patient characteristics, is essential for appropriate patient selection for salvage surgery.

Cerebroprotective effect of piracetam in patients undergoing open heart surgery.

PubMed

Holinski, Sebastian; Claus, Benjamin; Alaaraj, Nour; Dohmen, Pascal Maria; Neumann, Konrad; Uebelhack, Ralf; Konertz, Wolfgang

2011-01-01

Reduction of cognitive function is a possible side effect after the use of cardiopulmonary bypass (CPB) during cardiac surgery. Since it has been proven that piracetam is cerebroprotective in patients undergoing coronary bypass surgery, we investigated the effects of piracetam on the cognitive performance of patients undergoing open heart surgery. Patients scheduled for elective open heart surgery were randomized to the piracetam or placebo group in a double-blind study. Patients received 12 g of piracetam or placebo at the beginning of the operation. Six neuropsychological subtests from the Syndrom Kurz Test and the Alzheimer's Disease Assessment Scale were performed preoperatively and on day 3, postoperatively. To assess the overall cognitive function and the degree of cognitive decline across all tests after the surgery, we combined the six test-scores by principal component analysis. A total of 88 patients with a mean age of 67 years were enrolled into the study. The mean duration of CPB was 110 minutes. Preoperative clinical parameters and overall cognitive functions were not significantly different between the groups. The postoperative combined score of the neuropsychological tests showed deterioration of cognitive function in both groups (piracetam: preoperative 0.19 ± 0.97 vs. postoperative -0.97 ± 1.38, p <0.0005 and placebo: preoperative -0.14 ± 0.98 vs. postoperative -1.35 ± 1.23, p <0.0005). Patients taking piracetam did not perform better than those taking placebo, and both groups had the same decline of overall cognitive function (p = 0.955). Piracetam had no cerebroprotective effect in patients undergoing open heart surgery. Unlike the patients who underwent coronary surgery, piracetam did not reduce the early postoperative decline of neuropsychological abilities in heart valve patients.

Biomarkers for the clinical evaluation of the cognitively impaired elderly: amyloid is not enough

PubMed Central

McEvoy, Linda K; Brewer, James B

2012-01-01

The number of elderly patients seeking clinical treatment for memory problems will rise sharply in coming years as our population ages. These patients present a challenge for diagnosis and prognosis since cognitive problems in older patients can arise from many etiologies, some of which are curable. With the development of clinically available biomarkers for detecting Alzheimer’s disease pathology in living patients, evaluation of cognitively impaired elderly patients is about to undergo a major paradigm shift. This article describes the two classes of biomarkers available for assessing Alzheimer’s disease risk: those that indicate presence of amyloid pathology and those that provide evidence of neuronal injury and neurodegeneration. We argue that, currently, incorporation of biomarkers of neurodegeneration can help in patient prognosis whereas tests for amyloid, if used in isolation, have potential for harm. Amyloid tests are clinically useful only when evidence suggests progressive cognitive decline or neurodegeneration. PMID:23420460

"The impact of failing to identify suspect effort in patients undergoing adult attention-deficit/hyperactivity disorder (ADHD) assessment": Correction to Marshall et al. (2016).

PubMed

2016-10-01

Reports an error in "The Impact of Failing to Identify Suspect Effort in Patients Undergoing Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Assessment" by Paul S. Marshall, James B. Hoelzle, Danielle Heyerdahl and Nathaniel W. Nelson ( Psychological Assessment , Advanced Online Publication, Jan 11, 2016, np). In the article, the penultimate sentence of the abstract should read “These results suggest that a significant percentage of those making a suspect effort will be diagnosed with ADHD using the most commonly employed assessment methods: an interview alone (71%); an interview and ADHD behavior rating scales combined (65%); and an interview, behavior rating scales, and most continuous performance tests combined (62%).” All versions of this article have been corrected. (The following abstract of the original article appeared in record 2016-00618-001.) This retrospective study examines how many adult patients would plausibly receive a diagnosis of attention-deficit/hyperactivity disorder (ADHD) if performance and symptom validity measures were not administered during neuropsychological evaluations. Five hundred fifty-four patients were extracted from an archival clinical dataset. A total of 102 were diagnosed with ADHD based on cognitive testing, behavior rating scales, effort testing, and clinical interview; 115 were identified as putting forth suspect effort in accordance with the Slick, Sherman, and Iverson (1999) criteria. From a clinical decision-making perspective, suspect effort and ADHD groups were nearly indistinguishable on ADHD behavior, executive function, and functional impairment rating scales, as well as on cognitive testing and key clinical interview questions. These results suggest that a significant percentage of those making a suspect effort will be diagnosed with ADHD using the most commonly employed assessment methods: an interview alone (71%); an interview and ADHD behavior rating scales combined (65%); and an interview, behavior rating scales, and most continuous performance tests combined (57%). This research makes clear that it is essential to evaluate task engagement and possible symptom amplification during clinical evaluations. PsycINFO Database Record (c) 2016 APA, all rights reserved

Prognostic nutritional index is associated with survival after total gastrectomy for patients with gastric cancer.

PubMed

Ishizuka, Mitsuru; Oyama, Yusuke; Abe, Akihito; Tago, Kazuma; Tanaka, Genki; Kubota, Keiichi

2014-08-01

To investigate the influence of clinical characteristics including nutritional markers on postoperative survival in patients undergoing total gastrectomy (TG) for gastric cancer (GC). One hundred fifty-four patients were enrolled. Uni- and multivariate analyses using the Cox proportional hazard model were performed to explore the most valuable clinical characteristic that was associated with postoperative survival. Multivariate analysis using twelve clinical characteristics selected from univariate analyses revealed that age (≤ 72/>72), carcinoembryonic antigen (≤ 20/>20) (ng/ml), white blood cell count (≤ 9.5/>9.5) (× 10(3)/mm(3)), prognostic nutritional index (PNI) (≤ 45/>45) and lymph node metastasis (negative/positive) were associated with postoperative survival. Kaplan-Meier analysis and log-rank test showed that patients with higher PNI (>45) had a higher postoperative survival rate than those with lower PNI (≤ 45) (p<0.001). PNI is associated with postoperative survival of patients undergoing TG for GC and is able to divide such patients into two independent groups before surgery. Copyright© 2014 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

PHYSICAL EXAMINATIONS FOR DIAGNOSING MENISCAL INJURIES: CORRELATION WITH SURGICAL FINDINGS

PubMed Central

Gobbo, Ricardo da Rocha; Rangel, Victor de Oliveira; Karam, Francisco Consoli; Pires, Luiz Antônio Simões

2015-01-01

Objective: A set of five maneuvers for meniscal injuries (McMurray, Apley, Childress and Steinmann 1 and 2) was evaluated and their sensitivity, specificity, accuracy and likelihood were calculated. The same methods were applied to each test individually. Methods: One hundred and fifty-two patients of both sexes who were going to undergo videoarthroscopy on the knee were examined blindly by one of five residents at this hospital, without knowledge of the clinical data and why the patient was going to undergo an operation. This examination was conducted immediately before the videoarthroscopy and its results were recorded in an electronic spreadsheet. The set of maneuvers was considered positive when one was positive. In the individual analysis, it was enough for the test to be positive. Results: The analysis showed that the set of five meniscal tests presented sensitivity of 89%, specificity of 42%, accuracy of 75%, positive likelihood of 1.53 and negative likelihood of 0.26. Individually, the tests presented accuracy of between 48% and 53%. Conclusion: The set of maneuvers for meniscal injuries presented a good accuracy and significant value, especially for ruling out injury. Individually, the tests had less diagnostic value, although the Apley test had better specificity. PMID:27047833

Characterization of BRCA2 Mutation in a Series of Functional Assays

DTIC Science & Technology

2005-05-01

9 Appendices .................................................................................... 10 Abstract Mutations in the BRCA2 gene account for...approximately 20% of all hereditary breast cancer. Many individuals undergo expensive clinical testing for mutations in the BRCA2 gene in order to...BRCA2 breast and ovarian cancer predisposition gene was identified in 1995. Mutations in the gene account for approximately 20% of all hereditary breast

Short term clinical effectiveness of a 0.07% cetylpyridinium chloride mouth rinse in patients undergoing fixed orthodontic appliance treatment

PubMed Central

Pahwa, Narinder; Kumar, Atul; Gupta, Siddharth

2011-01-01

Objectives To test the short term clinical effectiveness of commercially available 0.07%.cetylpyridinium chloride mouth rinse in patients undergoing fixed orthodontic treatment as compared to a placebo mouth rinse and patients using toothbrush and toothpaste. Method Forty-five subjects for this double blind study were assigned randomly into three groups of 15 each. Gingival inflammation, plaque accumulation, and bleeding on probing, were recorded at baseline (10 days after prophylaxis), and at the end of one month in all the three groups and compared. Results Paired t test showed significant differences in bleeding index for pre and post treatment recordings for cetylpyridinium group. Modified gingival index showed no significant difference in the cetylpyridinium group. For plaque index significant difference was found for cetylpyridinium and control groups. Conclusion Cetylpyridinium mouth rinse 0.7% was found to be effective in reducing the bleeding and plaque index scores. It was not effective in reducing the modified gingival index scores. Cetylpyridinium mouth rinse 0.07% improves the oral hygiene of orthodontic patients when used as an adjunct to normal oral hygiene measures. PMID:23960507

The clinical features of angular cheilitis occurring during orthodontic treatment: a multi-centre observational study.

PubMed

Cross, David; Eide, May L; Kotinas, Anastasios

2010-06-01

To report the prevalence and clinical features of angular cheilitis occurring in patients undergoing orthodontic treatment. Cross-sectional, observational study. Three centres were involved; Glasgow Dental Hospital and two specialist orthodontic practices, one in Scotland and one in Greece. Six hundred and sixty consecutive patients undergoing orthodontic treatment were examined over a 9 month period. The presence and absence of angular cheilitis was recorded. A six-point clinical scale was used to describe the clinical features of angular cheilitis when present. Chi-squared tests were used to investigate the association between the presence of angular cheilitis and oral hygiene level/appliance type. Eleven per cent of orthodontic patients in this Western European population, showed signs of angular cheilitis. No correlation was found between the presence of angular cheilitis and gender. Good oral hygiene was associated with a reduced prevalence (P<0.01). Angular cheilitis is a multifactorial condition that can occur in a small percentage of patients during orthodontic treatment. Good oral hygiene may be associated with a reduced risk. A new clinical grade of angular cheilitis is suggested that may help future research. Further studies are required to investigate the microbiological features associated with angular cheilitis occurring in orthodontic patients, as well as associations with medical conditions, such as asthma.

Inspiratory Muscle Training and Functional Capacity in Patients Undergoing Cardiac Surgery.

PubMed

Cordeiro, André Luiz Lisboa; de Melo, Thiago Araújo; Neves, Daniela; Luna, Julianne; Esquivel, Mateus Souza; Guimarães, André Raimundo França; Borges, Daniel Lago; Petto, Jefferson

2016-04-01

Cardiac surgery is a highly complex procedure which generates worsening of lung function and decreased inspiratory muscle strength. The inspiratory muscle training becomes effective for muscle strengthening and can improve functional capacity. To investigate the effect of inspiratory muscle training on functional capacity submaximal and inspiratory muscle strength in patients undergoing cardiac surgery. This is a clinical randomized controlled trial with patients undergoing cardiac surgery at Instituto Nobre de Cardiologia. Patients were divided into two groups: control group and training. Preoperatively, were assessed the maximum inspiratory pressure and the distance covered in a 6-minute walk test. From the third postoperative day, the control group was managed according to the routine of the unit while the training group underwent daily protocol of respiratory muscle training until the day of discharge. 50 patients, 27 (54%) males were included, with a mean age of 56.7±13.9 years. After the analysis, the training group had significant increase in maximum inspiratory pressure (69.5±14.9 vs. 83.1±19.1 cmH2O, P=0.0073) and 6-minute walk test (422.4±102.8 vs. 502.4±112.8 m, P=0.0031). We conclude that inspiratory muscle training was effective in improving functional capacity submaximal and inspiratory muscle strength in this sample of patients undergoing cardiac surgery.

Intraperitoneal bupivacaine with or without incisional bupivacaine for postoperative analgesia in dogs undergoing ovariohysterectomy.

PubMed

Kalchofner Guerrero, Karin S; Campagna, Ivo; Bruhl-Day, Rodolfo; Hegamin-Younger, Cecilia; Guerrero, Tomas G

2016-09-01

Intraperitoneal (IP) bupivacaine provides postoperative analgesia in dogs undergoing ovariohysterectomy (OHE) alone or in combination with incisional (INC) bupivacaine. This study investigated whether the combination of INC and IP bupivacaine is superior to IP bupivacaine alone. Prospective, randomized, blinded clinical study. Thirty-nine privately owned dogs undergoing OHE, aged 25 ± 23 months and weighing 11.8 ± 5.7 kg. Dogs were premedicated with acepromazine (0.05 mg kg(-1) ) and morphine (0.5 mg kg(-1) ) intramuscularly (IM); anaesthesia was induced with propofol and maintained with isoflurane in oxygen. Carprofen (4 mg kg(-1) ) was administered subcutaneously (SC) after intubation. Bupivacaine (3 mg kg(-1) ) IP was administered before complete closure of the linea alba to all dogs. Dogs were randomly assigned into two groups: group B received bupivacaine (n = 20; 1 mg kg(-1) ) and group S received saline (n = 19; 0.2 mL kg(-1) ) INC as a subcutaneous 'splash' before skin closure. Postoperative analgesia was assessed with a dynamic interactive visual analogue scale, the short form of the Glasgow Composite Pain Scale, and mechanical nociceptive threshold (MNT) measurement at 0.5, 1, 2, 4, 6, 8, 12 and 20 hours after surgery by one blinded observer. Parametric data were tested using t-test; nonparametric data were analysed using the two-sample Wilcoxon test (p < 0.05). There was no significant difference between groups with regard to age, weight, surgical and anaesthetic duration, incision length, sedation and pain scores. MNT values decreased in both groups at all time points as compared with the baseline. No dog required rescue analgesia. No postoperative complications were observed. Bupivacaine IP and carprofen SC after morphine IM did provide satisfactory postoperative analgesia in dogs undergoing OHE with the anaesthetic protocol used. There appears to be no clinical advantage to adding bupivacaine INC. Neither protocol could prevent the development of primary hyperalgesia. © 2016 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia.

Hemochromatosis and Iron Overload Screening (HEIRS) study design for an evaluation of 100,000 primary care-based adults.

PubMed

McLaren, Christine E; Barton, James C; Adams, Paul C; Harris, Emily L; Acton, Ronald T; Press, Nancy; Reboussin, David M; McLaren, Gordon D; Sholinsky, Phyliss; Walker, Ann P; Gordeuk, Victor R; Leiendecker-Foster, Catherine; Dawkins, Fitzroy W; Eckfeldt, John H; Mellen, Beverly G; Speechley, Mark; Thomson, Elizabeth

2003-02-01

The HEIRS Study will evaluate the prevalence, genetic and environmental determinants, and potential clinical, personal, and societal impact of hemochromatosis and iron overload in a multiethnic, primary care-based sample of 100,000 adults over a 5-year period. Participants are recruited from 5 Field Centers. Laboratory testing and data management and analysis are performed in a Central Laboratory and Coordinating Center, respectively. Participants undergo testing for serum iron measures and common mutations of the hemochromatosis gene ( ) on chromosome 6p and answer questions on demographics, health, and genetic testing attitudes. Participants with elevated values of transferrin saturation and serum ferritin and/or C282Y homozygosity are invited to undergo a comprehensive clinical examination (CCE), as are frequency-matched control subjects. These examinations provide data on personal and family medical history, lifestyle characteristics, physical examination, genetic counseling, and assessment of ethical, legal, and social implications. Primary and secondary causes of iron overload will be distinguished by clinical criteria. Iron overload will be confirmed by quantification of iron stores. Recruiting family members of cases will permit DNA analysis for additional genetic factors that affect iron overload. Of the first 50,520 screened, 51% are white, 24% are African American, 11% are Asian, 11% are Hispanic, and 3% are of other, mixed, or unidentified race; 63% are female and 37% are male. Information from the HEIRS Study will inform policy regarding the feasibility, optimal approach, and potential individual and public health benefits and risks of primary care-based screening for iron overload and hemochromatosis.

Clinical pharmacogenetics implementation: approaches, successes, and challenges.

PubMed

Weitzel, Kristin W; Elsey, Amanda R; Langaee, Taimour Y; Burkley, Benjamin; Nessl, David R; Obeng, Aniwaa Owusu; Staley, Benjamin J; Dong, Hui-Jia; Allan, Robert W; Liu, J Felix; Cooper-Dehoff, Rhonda M; Anderson, R David; Conlon, Michael; Clare-Salzler, Michael J; Nelson, David R; Johnson, Julie A

2014-03-01

Current challenges exist to widespread clinical implementation of genomic medicine and pharmacogenetics. The University of Florida (UF) Health Personalized Medicine Program (PMP) is a pharmacist-led, multidisciplinary initiative created in 2011 within the UF Clinical Translational Science Institute. Initial efforts focused on pharmacogenetics, with long-term goals to include expansion to disease-risk prediction and disease stratification. Herein we describe the processes for development of the program, the challenges that were encountered and the clinical acceptance by clinicians of the genomic medicine implementation. The initial clinical implementation of the UF PMP began in June 2012 and targeted clopidogrel use and the CYP2C19 genotype in patients undergoing left heart catheterization and percutaneous-coronary intervention (PCI). After 1 year, 1,097 patients undergoing left heart catheterization were genotyped preemptively, and 291 of those underwent subsequent PCI. Genotype results were reported to the medical record for 100% of genotyped patients. Eighty patients who underwent PCI had an actionable genotype, with drug therapy changes implemented in 56 individuals. Average turnaround time from blood draw to genotype result entry in the medical record was 3.5 business days. Seven different third party payors, including Medicare, reimbursed for the test during the first month of billing, with an 85% reimbursement rate for outpatient claims that were submitted in the first month. These data highlight multiple levels of success in clinical implementation of genomic medicine. © 2014 Wiley Periodicals, Inc.

Opt-out provider-initiated HIV testing and counselling in primary care outpatient clinics in Zambia

PubMed Central

Chipukuma, Julien M; Chiko, Matimba M; Wamulume, Chibesa S; Bolton-Moore, Carolyn; Reid, Stewart E

2011-01-01

Abstract Objective To increase case-finding of infection with human immunodeficiency virus (HIV) in Zambia and their referral to HIV care and treatment by supplementing existing client-initiated voluntary counselling and testing (VCT), the dominant mode of HIV testing in the country. Methods Lay counsellors offered provider-initiated HIV testing and counselling (PITC) to all outpatients who attended primary clinics and did not know their HIV serostatus. Data on counselling and testing were collected in registers. Outcomes of interest included HIV testing coverage, the acceptability of testing, the proportion testing HIV-positive (HIV+), the proportion enrolling in HIV care and treatment and the time between testing and enrolment. Findings After the addition of PITC to VCT, the number tested for HIV infection in the nine clinics was twice the number undergoing VCT alone. Over 30 months, 44 420 patients were counselled under PITC and 31 197 patients, 44% of them men, accepted testing. Of those tested, 21% (6572) were HIV+; 38% of these HIV+ patients (2515) enrolled in HIV care and treatment. The median time between testing and enrolment was 6 days. The acceptability of testing rose over time. Conclusion The introduction of routine PITC using lay counsellors into health-care clinics in Lusaka, Zambia, dramatically increased the uptake and acceptability of HIV testing. Moreover, PITC was incorporated rapidly into primary care outpatient departments. Maximizing the number of patients who proceed to HIV care and treatment remains a challenge and warrants further research. PMID:21556300

Awareness of Pap testing and factors associated with intent to undergo Pap testing by level of sexual experience in unmarried university students in Korea: results from an online survey

PubMed Central

2014-01-01

Background Young and unmarried women have not been a target group for cervical cancer prevention in Korea. No previous studies have investigated the awareness of Pap testing, the intention to undergo Pap testing, or the factors associated with that intention, in this group of women. This information would be useful for an expansion in the focus of primary cervical cancer prevention. This study aimed to compare the awareness of Pap testing between groups of unmarried university students in Korea, and to investigate the factors associated with the intention to undergo Pap testing, by level of sexual experience. Methods A total of 475 unmarried university students who had never undergone a Pap test completed a web-based survey. Differences in awareness of the importance of the Pap test, confidence in Pap testing, intention to undergo the test, attitudes, subjective norms, perceived control, stigma, and shame by level of sexual experience were analysed using independent t-tests. Associations between measurement variables and intention to undergo Pap testing were analysed using correlation analysis. Variables yielding significant associations (p < 0.05) were included in a stepwise multiple regression model of intention to undergo Pap testing. Results Most participants perceived that the need for regular Pap testing was less important (score, 77.76) than other methods of cervical cancer prevention. They were not confident that is was an effective method of cervical cancer prevention for themselves (score, 59.56). There were differences in confidence in Pap testing and in the factors associated with intention to undergo Pap testing between sexually experienced and sexually inexperienced students. Regardless of level of sexual experience, the subjective norm was the most important predictor of intention to undergo Pap testing. Conclusions There was a low level of Pap screening awareness among the students. The factors associated with intention to undergo Pap testing differed by level of sexual experience. Social influence was an important factor that could be used to increase the intention to receive a Pap test in the university student population. Strategies to increase the intention to undergo Pap screening should be introduced and should be adapted to the level of sexual experience. PMID:25163938

Chlorhexidine allergy in four specialist allergy centres in the United Kingdom, 2009–13: clinical features and diagnostic tests

PubMed Central

Helbert, M.; Sargur, R.; Swallow, K.; Harper, N.; Garcez, T.; Savic, S.; Savic, L.; Eren, E.

2017-01-01

Summary We describe an observational survey of diagnostic pathways in 104 patients attending four specialist allergy clinics in the United Kingdom following perioperative hypersensitivity reactions to chlorhexidine reactions. The majority were life‐threatening. Men undergoing urological or cardiothoracic surgery predominated. Skin prick testing and specific immunoglobulin (sIg)E testing were the most common tests used for diagnosis. Fifty‐three per cent of diagnoses were made on the basis of a single positive test. Where multiple tests were performed the sensitivity of intradermal, basophil activation and skin prick testing was 68% (50–86%), 50% (10–90%) and 35% (17–55%), respectively. Seven per cent were negative on screening tests initially, and 12 cases were only positive for a single test despite multiple testing. Intradermal tests appeared most sensitive in this context. Additional sensitization to other substances used perioperatively, particularly neuromuscular blocking agents (NMBA), was found in 28 patients, emphasizing the need to test for possible allergy to all drugs to which the patient was exposed even where chlorhexidine is positive. PMID:28194756

Cognitive Function Before and After Left Heart Catheterization.

PubMed

Scott, David A; Evered, Lisbeth; Maruff, Paul; MacIsaac, Andrew; Maher, Sarah; Silbert, Brendan S

2018-03-10

Hospital procedures have been associated with cognitive change in older patients. This study aimed to document the prevalence of mild cognitive impairment in individuals undergoing left heart catheterization (LHC) before the procedure and the incidence of cognitive decline to 3 months afterwards. We conducted a prospective, observational, clinical investigation of elderly participants undergoing elective LHC. Cognition was assessed using a battery of written tests and a computerized cognitive battery before the LHC and then at 3 months afterwards. The computerized tests were also administered at 24 hours (or discharge) and 7 days after LHC. A control group of 51 community participants was recruited to calculate cognitive decline using the Reliable Change Index. Of 437 participants, mild cognitive impairment was identified in 226 (51.7%) before the procedure. Computerized tests detected an incidence of cognitive decline of 10.0% at 24 hours and 7.5% at 7 days. At 3 months, written tests detected an incidence of cognitive decline of 13.1% and computerized tests detected an incidence of 8.5%. Cognitive decline at 3 months using written tests was associated with increasing age, whereas computerized tests showed cognitive decline was associated with baseline amnestic mild cognitive impairment, diabetes mellitus, and prior coronary stenting. More than half the patients aged >60 years presenting for LHC have mild cognitive impairment. LHC is followed by cognitive decline in 8% to 13% of individuals at 3 months after the procedure. Subtle cognitive decline both before and after LHC is common and may have important clinical implications. URL: www.anzctr.org.au. Unique identifier: ACTRN12607000051448. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Microbial identification system for Space Station Freedom

NASA Technical Reports Server (NTRS)

Brown, Harlan D.; Scarlett, Janie B.; Skweres, Joyce A.; Fortune, Russell L.; Staples, John L.; Pierson, Duane L.

1989-01-01

The Environmental Health System (EHS) and Health Maintenance Facility (HMF) on Space Station Freedom will require a comprehensive microbiology capability. This requirement entails the development of an automated system to perform microbial identifications on isolates from a variety of environmental and clinical sources and, when required, to perform antimicrobial sensitivity testing. The unit currently undergoing development and testing is the Automated Microbiology System II (AMS II) built by Vitek Systems, Inc. The AMS II has successfully completed 12 months of laboratory testing and evaluation for compatibility with microgravity operation. The AMS II is a promising technology for use on Space Station Freedom.

Analyses of the Complexity of Patients Undergoing Attended Polysomnography in the Era of Home Sleep Apnea Tests

PubMed Central

Colaco, Brendon; Herold, Daniel; Johnson, Matthew; Roellinger, Daniel; Naessens, James M.; Morgenthaler, Timothy I.

2018-01-01

Study Objectives: Health care complexity includes dimensions of patient comorbidity and the level of services needed to meet patient demands. Home sleep apnea tests (HSAT) are increasingly used to test medically uncomplicated patients suspected of having moderate to severe obstructive sleep apnea (OSA). Patients with significant comorbidities or other sleep disorders are not candidates for HSAT and require attended in-center polysomnography. We hypothesized that this trend would result in increasingly complex patients being studied in sleep centers. Methods: Our study had two parts. To ascertain trends in sleep patient comorbidity, we used administrative diagnostic codes from patients undergoing polysomnography at the Mayo Clinic Center for Sleep Medicine from 2005 to June 2015 to calculate the Charlson and the Elixhauser comorbidity indices. We measured the level of services provided in two ways: (1) in a subset of patients from the past 2 months of 2015, we evaluated correlation of these morbidity indices with an internally developed Polysomnogram Clinical Index (PSGCI) rating anticipated patient care needs from 0 to 3 and (2) we measured the sleep study complexity based on polysomnography protocol design. Results: In 43,780 patients studied from 2005 to June 2015, the Charlson index increased from a mean of 1.38 to 1.88 (3.1% per year, P < .001) and the mean Elixhauser index increased from 2.61 to 3.35 (2.5% per year, P < .001). Both comorbidity indices were significantly higher at the highest (Level 3) level of the PSGCI (P < .001), and sleep study complexity increased over time. Conclusions: The complexity of patients undergoing attended polysomnography has increased by 28% to 36% over the past decade as measured by validated comorbidity indices, and these indices correlate with the complexity of rendered care during polysomnography. These findings have implications for increasing requirements for staffing, monitoring capabilities, and facility design of future sleep centers. Commentary: A commentary on this article appears in this issue on page 499. Citation: Colaco B, Herold D, Johnson M, Roellinger D, Naessens JM, Morgenthaler TI. Analyses of the complexity of patients undergoing attended polysomnography in the era of home sleep apnea tests. J Clin Sleep Med. 2018;14(4):631–639. PMID:29609716

Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial.

PubMed

Xhepa, Erion; Byrne, Robert A; Schulz, Stefanie; Helde, Sandra; Gewalt, Senta; Cassese, Salvatore; Linhardt, Maryam; Ibrahim, Tareq; Mehilli, Julinda; Hoppe, Katharina; Grupp, Katharina; Kufner, Sebastian; Böttiger, Corinna; Hoppmann, Petra; Burgdorf, Christof; Fusaro, Massimiliano; Ott, Ilka; Schneider, Simon; Hengstenberg, Christian; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan

2014-06-01

Vascular closure devices (VCD) have been introduced into clinical practice with the aim of increasing the procedural efficiency and clinical safety of coronary angiography. However, clinical studies comparing VCD and manual compression have yielded mixed results, and large randomised clinical trials comparing the two strategies are missing. Moreover, comparative efficacy studies between different VCD in routine clinical use are lacking. The Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial is a prospective, randomised clinical trial designed to compare the outcomes associated with the use of VCD or manual compression to achieve femoral haemostasis. The test hypothesis is that femoral haemostasis after coronary angiography achieved using VCD is not inferior to manual compression in terms of access-site-related vascular complications. Patients undergoing coronary angiography via the common femoral artery will be randomised in a 1:1:1 fashion to receive FemoSeal VCD, EXOSEAL VCD or manual compression. The primary endpoint is the incidence of the composite of arterial access-related complications (haematoma ≥5 cm, pseudoaneurysm, arteriovenous fistula, access-site-related bleeding, acute ipsilateral leg ischaemia, the need for vascular surgical/interventional treatment or documented local infection) at 30 days after randomisation. According to power calculations based on non-inferiority hypothesis testing, enrolment of 4,500 patients is planned. The trial is registered at www.clinicaltrials.gov (study identifier: NCT01389375). The safety of VCD as compared to manual compression in patients undergoing transfemoral coronary angiography remains an issue of clinical equipoise. The aim of the ISAR-CLOSURE trial is to assess whether femoral haemostasis achieved through the use of VCD is non-inferior to manual compression in terms of access-site-related vascular complications.

Awake craniotomy and multilingualism: language testing during anaesthesia for awake craniotomy in a bilingual patient.

PubMed

Costello, T G

2014-08-01

An awake craniotomy for epilepsy surgery is presented where a bilingual patient post-operatively reported temporary aphasia of his first language (Spanish). This case report discusses the potential causes for this clinical presentation and methods to prevent the occurrence of this in future patients undergoing this form of surgery. Copyright © 2014 Elsevier Ltd. All rights reserved.

Update on Molecular Testing for Cytologically Indeterminate Thyroid Nodules.

PubMed

Nishino, Michiya; Nikiforova, Marina

2018-04-01

- Approximately 15% to 30% of thyroid nodules that undergo fine-needle aspiration are classified as cytologically indeterminate, presenting management challenges for patients and clinicians alike. During the past several years, several molecular tests have been developed to reduce the diagnostic uncertainty of indeterminate thyroid fine-needle aspirations. - To review the methodology, clinical validation, and recent peer-reviewed literature for 4 molecular tests that are currently marketed for cytologically indeterminate thyroid fine-needle aspiration specimens: Afirma, ThyroSeq, ThyGenX/ThyraMIR, and RosettaGX Reveal. - Peer-reviewed literature retrieved from PubMed search, data provided by company websites and representatives, and authors' personal experiences. - The 4 commercially available molecular tests for thyroid cytology offer unique approaches to improve the risk stratification of thyroid nodules. Familiarity with data from the validation studies as well as the emerging literature about test performance in the postvalidation setting can help users to select and interpret these tests in a clinically meaningful way.

Specific balance training included in an endurance-resistance exercise program improves postural balance in elderly patients undergoing haemodialysis.

PubMed

Frih, Bechir; Mkacher, Wajdi; Jaafar, Hamdi; Frih, Ameur; Ben Salah, Zohra; El May, Mezry; Hammami, Mohamed

2018-04-01

The purpose of this study was to evaluate the effects of 6 months of specific balance training included in endurance-resistance program on postural balance in haemodialysis (HD) patients. Forty-nine male patients undergoing HD were randomly assigned to an intervention group (balance training included in an endurance-resistance training, n = 26) or a control group (resistance-endurance training only, n = 23). Postural control was assessed using six clinical tests; Timed Up and Go test, Tinetti Mobility Test, Berg Balance Scale, Unipodal Stance test, Mini-Balance Evaluation Systems Test and Activities Balance Confidence scale. All balance measures increased significantly after the period of rehabilitation training in the intervention group. Only the Timed Up and Go, Berg Balance Scale, Mini-Balance Evaluation Systems Test and Activities Balance Confidence scores were improved in the control group. The ranges of change in these tests were greater in the balance training group. In HD patients, specific balance training included in a usual endurance-resistance training program improves static and dynamic balance better than endurance-resistance training only. Implications for rehabilitation Rehabilitation using exercise in haemodialysis patients improved global mobility and functional abilities. Specific balance training included in usual endurance resistance training program could lead to improved static and dynamic balance.

Profile of Roche's Ariosa Harmony prenatal test.

PubMed

Bevilacqua, Elisa; Resta, Serena; Carlin, Andrew; Kang, Xin; Cos Sanchez, Teresa; de Marchin, Jérôme; Jani, Jacques C

2018-06-18

Roche's Ariosa Harmony TM Prenatal Test, a noninvasive cfDNA (cell-free DNA) method for major trisomies has been available since January-2013 at the authors unit and tests were sent to California. From July-2017 onwards, prenatal cfDNA has been reimbursed in Belgium for all pregnancies, however since then samples are sent to a local technology transfer center. Little data are available on patient's profile and choices towards cfDNA and on the performance of local technology transfer centers. Areas covered: The profiles and choices of women regarding this test were evaluated. Further, the performance of cfDNA at the local center was compared to the one in California. The results showed that women from the Netherlands, as compared to Belgium, were more likely to undergo cfDNA testing for maternal request and would be less likely to undergo karyotyping if cfDNA were unavailable, and therefore are better candidates for cfDNA testing, when this is used as first-line screening. The local test failure rate was nearly twice that of the main laboratory in California, however when repeated, the success rate was quite high. Expert commentary: The findings highlight the importance of conducting these types of studies, before decisions about clinical implementation are made by national governments and ministries of health.

Effect of caffeine on SPECT myocardial perfusion imaging during regadenoson pharmacologic stress: rationale and design of a prospective, randomized, multicenter study.

PubMed

Tejani, Furqan H; Thompson, Randall C; Iskandrian, Ami E; McNutt, Bruce E; Franks, Billy

2011-02-01

Caffeine attenuates the coronary hyperemic response to adenosine by competitive A₂(A) receptor blockade. This study aims to determine whether oral caffeine administration compromises diagnostic accuracy in patients undergoing vasodilator stress myocardial perfusion imaging (MPI) with regadenoson, a selective adenosine A(2A) agonist. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study includes patients with suspected coronary artery disease who regularly consume caffeine. Each participant undergoes three SPECT MPI studies: a rest study on day 1 (MPI-1); a regadenoson stress study on day 3 (MPI-2), and a regadenoson stress study on day 5 with double-blind administration of oral caffeine 200 or 400 mg or placebo capsules (MPI-3; n = 90 per arm). Only participants with ≥ 1 reversible defect on the second MPI study undergo the subsequent stress MPI test. The primary endpoint is the difference in the number of reversible defects on the two stress tests using a 17-segment model. Pharmacokinetic/pharmacodynamic analyses will evaluate the effect of caffeine on the regadenoson exposure-response relationship. Safety will also be assessed. The results of this study will show whether the consumption of caffeine equivalent to 2-4 cups of coffee prior to an MPI study with regadenoson affects the diagnostic validity of stress testing (ClinicalTrials.gov number, NCT00826280).

Minimal cosmetic revision required after minimally invasive pectus repair.

PubMed

Murphy, Brittany L; Naik, Nimesh D; Roskos, Penny L; Glasgow, Amy E; Moir, Christopher R; Habermann, Elizabeth B; Klinkner, Denise B

2018-05-09

Despite surgical correction procedures for pectus deformities, remaining cosmetic asymmetry may have significant psychological effects. We sought to evaluate factors associated with plastic surgery (PS) consultation and procedures for these deformities at an academic institution. We reviewed patients aged 0-21 diagnosed with a pectus excavatum or carinatum deformity at our institution between January 2001 and October 2016. Pectus diagnoses were identified by ICD-9/ICD-10 codes and surgical repair by CPT codes; patients receiving PS consultation were identified by clinical note service codes. Student's t tests, Fisher's exact tests, and Chi-squared tests were utilized. 2158 patients were diagnosed with a pectus deformity; 442 (20.4%) underwent surgical correction. 19/442 (4.3%) sought PS consultation, either for pectus excavatum [14/19 (73.7%)], carinatum [4/19 (21.0%)], and both [1/19 (5.3%)], (p = 0.02). Patients seeking PS consultation were more likely to be female (p < 0.01), have scoliosis (p = 0.02), or undergo an open repair (p < 0.01). The need for PS consultation did not correlate with Haller index, p = 0.78. PS consultation associated with pectus deformity repair was rare, occurring in < 5% of patients undergoing repair. Patients who consulted PS more commonly included females, patients with scoliosis, and those undergoing open repair. These patients would likely benefit most from multidisciplinary pre-operative discussions regarding repair of the global deformity.

Platelet Aggregometry Testing: Molecular Mechanisms, Techniques and Clinical Implications

PubMed Central

Koltai, Katalin; Kesmarky, Gabor; Feher, Gergely; Tibold, Antal

2017-01-01

Platelets play a fundamental role in normal hemostasis, while their inherited or acquired dysfunctions are involved in a variety of bleeding disorders or thrombotic events. Several laboratory methodologies or point-of-care testing methods are currently available for clinical and experimental settings. These methods describe different aspects of platelet function based on platelet aggregation, platelet adhesion, the viscoelastic properties during clot formation, the evaluation of thromboxane metabolism or certain flow cytometry techniques. Platelet aggregometry is applied in different clinical settings as monitoring response to antiplatelet therapies, the assessment of perioperative bleeding risk, the diagnosis of inherited bleeding disorders or in transfusion medicine. The rationale for platelet function-driven antiplatelet therapy was based on the result of several studies on patients undergoing percutaneous coronary intervention (PCI), where an association between high platelet reactivity despite P2Y12 inhibition and ischemic events as stent thrombosis or cardiovascular death was found. However, recent large scale randomized, controlled trials have consistently failed to demonstrate a benefit of personalised antiplatelet therapy based on platelet function testing. PMID:28820484

Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery

PubMed Central

Warner, Matthew A; Welsby, Ian J; Norris, Phillip J; Silliman, Christopher C; Armour, Sarah; Wittwer, Erica D; Santrach, Paula J; Meade, Laurie A; Liedl, Lavonne M; Nieuwenkamp, Chelsea M; Douthit, Brian; van Buskirk, Camille M; Schulte, Phillip J; Kor, Daryl J

2017-01-01

Introduction The transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care (POC) washing of allogeneic RBCs may remove these BRMs, thereby mitigating their impact on post-transfusion respiratory complications. Methods and analysis This is a multicenter randomised clinical trial of standard allogeneic versus washed allogeneic RBC transfusion for adult patients undergoing cardiac surgery testing the hypothesis that POC RBC washing is feasible, safe, and efficacious and will reduce recipient immune and physiologic responses associated with transfusion-related respiratory complications. Relevant clinical outcomes will also be assessed. This investigation will enrol 170 patients at two hospitals in the USA. Simon’s two-stage design will be used to assess the feasibility of POC RBC washing. The primary safety outcomes will be assessed using Wilcoxon Rank-Sum tests for continuous variables and Pearson chi-square test for categorical variables. Standard mixed modelling practices will be employed to test for changes in biomarkers of lung injury following transfusion. Linear regression will assess relationships between randomised group and post-transfusion physiologic measures. Ethics and dissemination Safety oversight will be conducted under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained by the DSMB as well as the institutional review boards at each institution prior to enrolling the first study participant. This study aims to provide important information regarding the feasibility of POC washing of allogeneic RBCs and its potential impact on ameliorating post-transfusion respiratory complications. Additionally, it will inform the feasibility and scientific merit of pursuing a more definitive phase II/III clinical trial. Registration ClinicalTrials.gov registration number is NCT02094118 (Pre-results). PMID:28821525

Molecular and Nonmolecular Diagnostic Methods for Invasive Fungal Infections

PubMed Central

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

2014-01-01

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

Novel end points for clinical trials in young children with cystic fibrosis.

PubMed

Simpson, Shannon J; Mott, Lauren S; Esther, Charles R; Stick, Stephen M; Hall, Graham L

2013-06-01

Cystic fibrosis (CF) lung disease commences early in the disease progression and is the most common cause of mortality. While new CF disease-modifying agents are currently undergoing clinical trial evaluation, the implementation of such trials in young children is limited by the lack of age-appropriate clinical trial end points. Advances in infant and preschool lung function testing, imaging of the chest and the development of biochemical biomarkers have led to increased possibility of quantifying mild lung disease in young children with CF and objectively monitoring disease progression over the course of an intervention. Despite this, further standardization and development of these techniques is required to provide robust objective measures for clinical trials in this age group.

Conceptual Model of Research to Reduce Stigma Related to Mental Disorders in Adolescents

PubMed Central

Pinto-Foltz, Melissa D.; Logsdon, M. Cynthia

2010-01-01

Purpose: To explicate an initial conceptual model that is amenable to testing and guiding anti-stigma interventions with adolescents. Design/Sources Used: Multidisciplinary research and theoretical articles were reviewed. . Conclusions: The conceptual model may guide anti-stigma interventions, and undergo testing and refinement in the future to reflect scientific advances in stigma reduction among adolescents. Use of a conceptual model enhances empirical evaluation of anti-stigma interventions yielding a casual explanation for the intervention effects and enhances clinical applicability of interventions across settings. PMID:19916813

Clinical Characteristics of Disaccharidase Deficiencies Among Children Undergoing Upper Endoscopy.

PubMed

Cohen, Stanley A; Oloyede, Hannah; Gold, Benjamin D; Mohammed, Aminu; Elser, Heather E

2018-06-01

The epidemiology and clinical significance of disaccharidase deficiencies have not been thoroughly characterized. Recent work suggests at least genetic sucrase-isomaltase deficiency is more prevalent than previously believed. Because lactase deficiency (LD) is well described, the present study focuses on the clinical characteristics of children with disaccharidase deficiencies determined by esophagogastroduodenoscopy. Endoscopic records were reviewed from patients undergoing esophagogastroduodenoscopies with biopsies assayed for disaccharidase activity performed by 13 pediatric gastroenterologists during 5 years (2010-2014). Presenting symptoms, clinical and histological diagnosis, treatment, disaccharidase results, and demographic variables were obtained from medical and endoscopic records of those with maltase and sucrase deficiency (SD). Among 963 patients undergoing intestinal disaccharidase testing, 73 (7.6%) had SD on biopsy (enzyme activity <25 μmol · min · g). Thirty-four (34/73; 47%) had normal duodenal histology and are the focus of this report. Four patients had SD without LD. Pan-disaccharidase deficiency was observed in 24 patients when maltase and palatinase assays were obtained (n = 646), and 11 had SD + LD when just those 2 enzymes were analyzed (n = 317). Those with SD without LD were younger 4.6 ± 6.1 versus 14.1 ± 3.6 years and uniformly presented with diarrhea. Patients with pan-disaccharidase deficiency or SD + LD primarily reported abdominal pain (33/35; 94%), diarrhea (16/35; 46%), nausea (14/35; 40%); and poor weight gain/weight loss (10/35; 29%); constipation, flatulence, and bloating were also noted. Maltase deficiency is less common (8/963; 0.8%), presenting with similar symptoms. Genetic sucrase-isomaltase deficiency often occurs together with lactase or pan-disaccharide deficiency. Disaccharidase deficiency should be considered a potential cause of abdominal pain and/or diarrhea in children and adolescents.

Postoperative Swallowing Assessment After Lung Transplantation.

PubMed

Baumann, Brooke; Byers, Sara; Wasserman-Wincko, Tamara; Smith, Libby; Hathaway, Bridget; Bhama, Jay; Shigemura, Norihisa; Hayanga, J W Awori; D'Cunha, Jonathan; Johnson, Jonas T

2017-07-01

Dysphagia, aspiration, and potential pneumonia represent a major source of morbidity in patients undergoing lung transplantation. Conditions that potentiate dysphagia and aspiration include frailty and prolonged intubation. Our group of speech-language pathologists has been actively involved in performance of a bedside evaluation of swallowing, and instrumental evaluation of swallowing with modified barium swallow, and postoperative management in patients undergoing lung transplantation. All lung transplant patients from April 2009 to September 2012 were evaluated retrospectively. A clinical bedside examination was performed by the speech-language pathology team, followed by a modified barium swallow or fiberoptic endoscopic evaluation of swallowing. A total of 321 patients were referred for evaluation. Twenty-four patients were unable to complete the evaluation. Clinical signs of aspiration were apparent in 160 patients (54%). Deep laryngeal penetration or aspiration were identified in 198 (67%) patients during instrumental testing. A group of 81 patients (27%) had an entirely normal clinical examination, but were found to have either deep penetration or aspiration. The majority of patients aspirate after lung transplantation. Clinical bedside examination is not sensitive enough and will fail to identify patients with silent aspiration. A standard of practice following lung transplantation has been established that helps avoid postoperative aspiration associated with complications. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Whole-body isometric force/torque measurements for functional assessment in neuro-rehabilitation: platform design, development and verification.

PubMed

Mazzoleni, Stefano; Toth, Andras; Munih, Marko; Van Vaerenbergh, Jo; Cavallo, Giuseppe; Micera, Silvestro; Dario, Paolo; Guglielmelli, Eugenio

2009-10-30

One of the main scientific and technological challenges of rehabilitation bioengineering is the development of innovative methodologies, based on the use of appropriate technological devices, for an objective assessment of patients undergoing a rehabilitation treatment. Such tools should be as fast and cheap to use as clinical scales, which are currently the daily instruments most widely used in the routine clinical practice. A human-centered approach was used in the design and development of a mechanical structure equipped with eight force/torque sensors that record quantitative data during the initiation of a predefined set of Activities of Daily Living (ADL) tasks, in isometric conditions. Preliminary results validated the appropriateness, acceptability and functionality of the proposed platform, that has become now a tool used for clinical research in three clinical centres. This paper presented the design and development of an innovative platform for whole-body force and torque measurements on human subjects. The platform has been designed to perform accurate quantitative measurements in isometric conditions with the specific aim to address the needs for functional assessment tests of patients undergoing a rehabilitation treatment as a consequence of a stroke.The versatility of the system also enlightens several other interesting possible areas of application for therapy in neurorehabilitation, for research in basic neuroscience, and more.

The pursuit of certainty in diagnosing dementia: cognitive testing, childishness and stress in two British memory clinics.

PubMed

Orr, David M R

2010-12-01

By often taking as its focus the experience of illness in itself, medical anthropology has sometimes neglected the meanings that patients may assign to the diagnostic procedures that they are expected to undergo. This paper puts into anthropological perspective the author's experiences working as an assistant psychologist in two British memory clinics for the detection and treatment of dementia, using comments by patients to illustrate the significance that one aspect of these procedures--cognitive testing--had for them. These comments suggest that the meanings that patients construct with regard to such testing are complex and cannot be understood if one persists in seeing it as a neutral diagnostic tool without broader implications. It is argued that a strong association made by many patients between the cognitive tests and their childhood school experiences informs their reactions for better or worse. It is important to acknowledge the implications of this active interpretation of medical procedures if the memory clinic experience is not to become an alienating and infantilising one.

The Saudi clinical practice guideline for the diagnosis of the first deep venous thrombosis of the lower extremity

PubMed Central

Al-Hameed, Fahad; Al-Dorzi, Hasan M; Shamy, Abdulrahman; Qadi, Abdulelah; Bakhsh, Ebtisam; Aboelnazar, Essam; Abdelaal, Mohamad; Al Khuwaitir, Tarig; Al-Moamary, Mohamed S.; Al-Hajjaj, Mohamed S.; Brozek, Jan; Schünemann, Holger; Mustafa, Reem; Falavigna, Maicon

2015-01-01

The diagnosis of deep venous thrombosis (DVT) may be challenging due to the inaccuracy of clinical assessment and diversity of diagnostic tests. On one hand, missed diagnosis may result in life-threatening conditions. On the other hand, unnecessary treatment may lead to serious complications. As a result of an initiative of the Ministry of Health of the Kingdom of Saudi Arabia (KSA), an expert panel led by the Saudi Association for Venous Thrombo-Embolism (SAVTE; a subsidiary of the Saudi Thoracic Society) with the methodological support of the McMaster University Working Group, produced this clinical practice guideline to assist healthcare providers in evidence-based clinical decision-making for the diagnosis of a suspected first DVT of the lower extremity. Twenty-four questions were identified and corresponding recommendations were made following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. These recommendations included assessing the clinical probability of DVT using Wells criteria before requesting any test and undergoing a sequential diagnostic evaluation, mainly using highly sensitive D-dimer by enzyme-linked immunosorbent assay (ELISA) and compression ultrasound. Although venography is the reference standard test for the diagnosis of DVT, its use was not recommended. PMID:25593601

Temporal Trends in Clinical and Pathological Characteristics for Men Undergoing Radical Prostatectomy Between 1995 and 2013 at Rigshospitalet, Copenhagen, Denmark, and Stanford University Hospital, United States.

PubMed

Loft, Mathias Dyrberg; Berg, Kasper Drimer; Kjaer, Andreas; Iversen, Peter; Ferrari, Michelle; Zhang, Chiyuan A; Brasso, Klaus; Brooks, James D; Røder, Martin Andreas

2017-09-06

To analyze how prostate-specific antigen (PSA) screening and practice patterns has affected trends in tumor characteristics in men undergoing radical prostatectomy (RP) in the United States and Denmark. Unlike in the United States, PSA screening has not been recommended in Denmark. We performed an observational register study using pre- and postoperative data on 2168 Danish patients from Rigshospitalet, Copenhagen, Denmark, and 2236 patients from Stanford University Hospital, Stanford, CA, who underwent RP between 1995 and 2013. Patients were stratified according to Cancer of the Prostate Risk Assessment-Postsurgical (CAPRA-S) risk groups and D'Amico risk classification and were clustered into 4 time periods (1995-1999, 2000-2004, 2005-2009, and 2010-2013). Temporal trends in the proportions of patients of a given variable at the 2 institutions were evaluated with Cochran-Armitage test for trends and chi-square testing. A total of 4404 patients were included. Temporal changes in preoperative PSA, age, grade, and stage was found in both cohorts. Median preoperative PSA declined in both cohorts, while median age increased, with the Danish cohort showing the greatest changes in both PSA and age. In both cohorts, there was a trend for higher-risk preoperative features before RP over time. In 2010-2013, 27.7% and 21.8% of the patients were in the D'Amico high-risk group at Copenhagen and Stanford, respectively. Despite recommendation against PSA screening in Denmark, Danish men undergoing RP at Rigshospitalet to a considerable extent now resemble American men undergoing RP at Stanford. At both sites, there is continued trend to reduce the number of men undergoing RP for low-risk prostate cancer. Copyright © 2017 Elsevier Inc. All rights reserved.

[Clinical outcomes and economic analysis of two ovulation induction protocols in patients undergoing repeated IVF/ICSI cycles].

PubMed

Chen, Xiao; Geng, Ling; Li, Hong

2014-04-01

To compare the clinical outcomes and cost-effectiveness of luteal phase down-regulation with gonadotrophin-releasing hormone (GnRH) agonist protocol and GnRH antagonist protocol in patients undergoing repeated in vitro fertilization and intracytoplasmic sperm injection (IVF-ICSI) cycles. A retrospective analysis of clinical outcomes and costs was conducted among 198 patients undergoing repeated IVF-ICSI cycles, including 109 receiving luteal phase down-regulation with GnRH agonist protocol (group A) and 89 receiving GnRH antagonist protocol (group B). The numbers of oocytes retrieved and good embryos, clinical pregnancy rate, abortion rate, the live birth rate, mean total cost, and the cost-effective ratio were compared between the two groups. In patients undergoing repeated IVF-ICSI cycles, the two protocols produced no significant differences in the number of good embryos, clinical pregnancy rate, abortion rate, or twin pregnancy rate. Compared with group B, group A had better clinical outcomes though this difference was not statistically significant. The number of retrieved oocytes was significantly greater and live birth rate significantly higher in group A than in group B (9.13=4.98 vs 7.11=4.74, and 20.2% vs 9.0%, respectively). Compared with group B, group A had higher mean total cost per cycle but lower costs for each oocyte retrieved (2729.11 vs 3038.60 RMB yuan), each good embryo (8867.19 vs 9644.85 RMB yuan), each clinical pregnancy (77598.06 vs 96139.85 RMB yuan). For patients undergoing repeated IVF/ICSI cycle, luteal phase down-regulation with GnRH agonist protocol produces good clinical outcomes with also good cost-effectiveness in spite an unsatisfactory ovarian reserve.

The Female Pattern Hair Loss: Review of Etiopathogenesis and Diagnosis

PubMed Central

Vujovic, Anja; Del Marmol, Véronique

2014-01-01

Female pattern hair loss (FPHL) is the most common hair loss disorder in women. Initial signs may develop during teenage years leading to a progressive hair loss with a characteristic pattern distribution. The condition is characterized by progressive replacement of terminal hair follicles over the frontal and vertex regions by miniaturized follicles, that leads progressively to a visible reduction in hair density. Women diagnosed with FPHL may undergo significant impairment of quality of life. FPHL diagnosis is mostly clinical. Depending on patient history and clinical evaluation, further diagnostic testing may be useful. The purpose of the paper is to review the current knowledge about epidemiology, pathogenesis, clinical manifestations, and diagnosis of FPHL. PMID:24812631

Effect of acupuncture on in vitro fertilization: An updated systematic review and data mining protocol.

PubMed

Wang, Xiaotong; Lin, Haixiong; Chen, Mingzhu; Wang, Jian; Jin, Yuanlin

2018-06-01

Although many patients try to seek acupuncture to improve in vitro fertilization (IVF) outcomes, evidence regarding its efficacy and acupoints characters are lacking. The aim of this protocol is to evaluate the effectiveness and safety, as well as the acupoints characteristics of acupuncture in the treatment of female undergoing IVF, by conducting a systematic review and data mining. The following 6 databases will be searched from their inception to April 30, 2018: PubMed, Chinese National Knowledge Infrastructure, Wanfang, VIP database, Embase, and Cochrane Library. The randomized controlled trials (RCTs) or case-control studies of acupuncture that assess clinical effects and side effects in female undergoing IVF are included. The primary outcome measures will be number of oocytes retrieved, fertilization rate, oocyte cleavage rate, high-quality embryos rate, ovarian hyperstimulation syndrome (OHHS) incidence rate, clinical pregnancy rate (CPR), biochemical pregnancy rate (BPR), implantation rate, and cycle cancellation rate. Two reviewers will independently undertake data extraction and quality assessments. Data will be synthesized by RevMan V.5.3 software. Acupoints characteristics will be excavated using Traditional Chinese Medicine inheritance support system (TCMISS). Reporting bias will be assessed by Funnel plots, Begg test, and Egger test. This review will assess the clinical efficacy and safety, as well as the acupoints characteristics of acupuncture on IVF. These findings will summarize the current evidence of acupuncture on IVF outcomes and may provide guidance for clinicians and infertile women to select acupuncture for IVF.

Preventive medicines: vaccination, prophylaxis of infectious diseases, disinfectants.

PubMed

Heininger, Ulrich

2011-01-01

Immunizations belong to the most successful interventions in medicine. Like other drugs, vaccines undergo long periods of pre-clinical development, followed by careful clinical testing through study Phases I, II, and III before they receive licensure. A successful candidate vaccine will move on to be an investigational vaccine to undergo three phases of pre-licensure clinical trials in a stepwise fashion before it can be considered for approval, followed by an optional fourth phase of post-marketing assessment. The overall risk-benefit assessment of a candidate vaccine is very critical in making the licensure decision for regulatory authorities, supported by their scientific committees. It includes analyses of immunogenicity, efficacy, reactogenicity or tolerability, and safety of the vaccine. Public trust in vaccines is a key to the success of immunization programs worldwide. Maintaining this trust requires knowledge of the benefits and scientific understanding of real or perceived risks of immunizations. Under certain circumstances, pre- or post-exposure passive immunization can be achieved by administration of immunoglobulines. In terms of prevention of infectious diseases, disinfection can be applied to reduce the risk of transmission of pathogens from patient to patient, health-care workers to patients, patients to health-care workers, and objects or medical devices to patients.

In vitro assessment of skin irritation potential of surfactant-based formulations by using a 3-D skin reconstructed tissue model and cytokine response.

PubMed

Walters, Russel M; Gandolfi, Lisa; Mack, M Catherine; Fevola, Michael; Martin, Katharine; Hamilton, Mathew T; Hilberer, Allison; Barnes, Nicole; Wilt, Nathan; Nash, Jennifer R; Raabe, Hans A; Costin, Gertrude-Emilia

2016-12-01

The personal care industry is focused on developing safe, more efficacious, and increasingly milder products, that are routinely undergoing preclinical and clinical testing before becoming available for consumer use on skin. In vitro systems based on skin reconstructed equivalents are now established for the preclinical assessment of product irritation potential and as alternative testing methods to the classic Draize rabbit skin irritation test. We have used the 3-D EpiDerm™ model system to evaluate tissue viability and primary cytokine interleukin-1α release as a way to evaluate the potential dermal irritation of 224 non-ionic, amphoteric and/or anionic surfactant-containing formulations, or individual raw materials. As part of our testing programme, two representative benchmark materials with known clinical skin irritation potential were qualified through repeated testing, for use as references for the skin irritation evaluation of formulations containing new surfactant ingredients. We have established a correlation between the in vitro screening approach and clinical testing, and are continually expanding our database to enhance this correlation. This testing programme integrates the efforts of global manufacturers of personal care products that focus on the development of increasingly milder formulations to be applied to the skin, without the use of animal testing. 2016 FRAME.

Laboratory diagnosis of Ebola virus disease and corresponding biosafety considerations in the China Ebola Treatment Center.

PubMed

Huang, Qing; Fu, Wei-Ling; You, Jian-Ping; Mao, Qing

2016-10-01

Ebola virus disease (EVD), caused by Ebola virus (EBOV), is a potent acute infectious disease with a high case-fatality rate. Etiological and serological EBOV detection methods, including techniques that involve the detection of the viral genome, virus-specific antigens and anti-virus antibodies, are standard laboratory diagnostic tests that facilitate confirmation or exclusion of EBOV infection. In addition, routine blood tests, liver and kidney function tests, electrolytes and coagulation tests and other diagnostic examinations are important for the clinical diagnosis and treatment of EVD. Because of the viral load in body fluids and secretions from EVD patients, all body fluids are highly contagious. As a result, biosafety control measures during the collection, transport and testing of clinical specimens obtained from individuals scheduled to undergo EBOV infection testing (including suspected, probable and confirmed cases) are crucial. This report has been generated following extensive work experience in the China Ebola Treatment Center (ETC) in Liberia and incorporates important information pertaining to relevant diagnostic standards, clinical significance, operational procedures, safety controls and other issues related to laboratory testing of EVD. Relevant opinions and suggestions are presented in this report to provide contextual awareness associated with the development of standards and/or guidelines related to EVD laboratory testing.

[Alice in Wonderland syndrome].

PubMed

Asensio-Sánchez, V M

2014-02-01

A case of Alice in Wonderland syndrome is described as the only sign of Epstein-Barr virus infection. Epstein-Barr virus infection may include visual symptoms as the first or only signs of disease. All patients presenting with a clinical picture consistent with the Alice in Wonderland syndrome should undergo serological testing for Epstein-Barr virus infection. Copyright © 2011 Sociedad Española de Oftalmología. Published by Elsevier Espana. All rights reserved.

Delirium, Frailty, and Fast-Track Surgery in Oncogeriatrics: Is There a Link?

PubMed Central

Monacelli, Fiammetta; Signori, Alessio; Prefumo, Matteo; Giannotti, Chiara; Nencioni, Alessio; Romairone, Emanuele; Scabini, Stefano; Odetti, Patrizio

2018-01-01

Background/Aims Postoperative delirium (POD) is more frequent in elderly patients undergoing major cancer surgery. The interplay between individual clinical vulnerability and a series of perioperative factors seems to play a relevant role. Surgery is the first-line treatment option for cancer, and fast-track surgery (FTS) has been documented to decrease postoperative complications. The study sought to assess, after comprehensive geriatric assessment (CGA) and frailty stratification (Rockwood 40 items index), which perioperative parameters were predictive of POD development in elderly patients undergoing FTS for colorectal cancer. Methods A total of 107 consecutive subjects admitted for elective colorectal FTS were enrolled. All patients underwent CGA, frailly stratification, Timed up & go (TUG) test, 4AT test for delirium screening, anesthesiologists physical status classification, and Dindo-Clavien classification. Results The incidence of POD was 12.3%. Patients’ prevalent clinical phenotype was pre-frail. The multivariate analysis indicated physical performance (TUG in seconds) as the most significant predictor of POD for each second of increase. Conclusions Only few procedure-specific studies have examined the impact of FTS for colorectal cancer on POD. This is the first study to investigate the risk factors for POD, in a vulnerable octogenarian oncogeriatric population submitted to FTS surgery and frailty stratification. PMID:29515621

Iliac artery stenting in patients with poor distal runoff: Influence of concomitant infrainguinal arterial reconstruction.

PubMed

Timaran, Carlos H; Ohki, Takao; Gargiulo, Nicholas J; Veith, Frank J; Stevens, Scott L; Freeman, Michael B; Goldman, Mitchell H

2003-09-01

Inadequate infrainguinal runoff is considered an important risk factor for iliac stent failure. However, the influence of concomitant infrainguinal arterial reconstruction (CIAR) on iliac stent patency is unknown. This study evaluated the influence of CIAR on outcome of iliac angioplasty and stenting (IAS) in patients with poor distal runoff. Over 5 years (1996 to 2001), 68 IAS procedures (78 stents) were performed in 62 patients with poor distal runoff (angiographic runoff score >or=5). The SVS/AAVS reporting standards were followed to define outcome variables and risk factors. Data were analyzed with both univariate analysis (Kaplan-Meier method [K-M]) and regression analysis (Cox proportional hazards model). Indications for iliac artery stenting were disabling claudication (59%) and limb salvage (41%). Of the 68 procedures, IAS with CIAR was performed in 31 patients (46%), and IAS alone was performed in 37 patients (54%). Patients undergoing IAS with CIAR were older (P =.03) and had more extensive and multifocal iliac artery occlusive disease, with more TASC (TransAtlantic Inter-Society Consensus) type C lesions (P =.03), compared with patients undergoing IAS alone. No other significant differences in risk factors were noted. Runoff scores between patients undergoing IAS with CIAR and those undergoing IAS alone were not significantly different (median runoff scores, 6 [range, 5-8] and 7 [range, 5-9], respectively; P =.77). Primary stent patency rate at 1, 3, and 5 years was 87%, 54%, and 42%, respectively, for patients undergoing IAS with CIAR, and was 76%, 66%, and 55%, respectively, for patients undergoing IAS. Univariate analysis revealed that primary stent patency rate was not significantly different between the 2 groups (K-M, log-rank test, P =.81). Primary graft patency rate for CIAR was 81%, 52%, and 46% at 1, 3, and 5 years, respectively. Performing CIAR did not affect primary iliac stent patency (relative risk, 1.1; 95% confidence interval, 0.49-2.47; P =.81). Overall, there was a trend toward improved limb salvage in patients undergoing IAS with CIAR, compared with those undergoing IAS alone (K-M, log rank test, P =.07). In patients undergoing IAS with poor distal runoff, CIAR does not improve iliac artery stent patency. Infrainguinal bypass procedures should therefore be reserved for patients who do not demonstrate clinical improvement and possibly for those with limb-threatening ischemia.

Urine Creatinine Concentrations in Drug Monitoring Participants and Hospitalized Patients.

PubMed

Love, Sara A; Seegmiller, Jesse C; Kloss, Julie; Apple, Fred S

2016-10-01

Urine drug testing is commonly performed in both clinical and forensic arenas for screening, monitoring and compliance purposes. We sought to determine if urine creatinine concentrations in monitoring program participants were significantly different from hospital in-patients and out-patients undergoing urine drug testing. We retrospectively reviewed urine creatinine submitted in June through December 2015 for all specimens undergoing urine drug testing. The 20,479 creatinine results were categorized as hospitalized patients (H) and monitoring/compliance groups for pain management (P), legal (L) or recovery (R). Median creatinine concentrations (interquartile range, mg/dL) were significantly different (P < 0.001) between groups: H 126 (122-136); P 138 (137-143); L 147 (144-154); R 95 (92-97). In the two groups subject to on-demand sampling time pressures, median creatinine concentrations were significantly lower in the R vs. L group (P<0.001). In conclusion, recovery (R) participants have more dilute specimens, reflected by significantly lower creatinine concentration and may indicate participants' attempts to tamper with their drug test results through dilution means. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Clinical impression and ascites appearance do not rule out bacterial peritonitis.

PubMed

Chinnock, Brian; Hendey, Gregory W; Minnigan, Hal; Butler, Jack; Afarian, Hagop

2013-05-01

Previous research has demonstrated that physician clinical suspicion, determined without assessing fluid appearance, is not adequate to rule out spontaneous bacterial peritonitis (SBP) without fluid testing. To determine the sensitivity of physician clinical suspicion, including a bedside assessment of fluid appearance, in the detection of SBP in Emergency Department (ED) patients undergoing paracentesis. We conducted a prospective, observational study of ED patients with ascites undergoing paracentesis at three academic facilities. The enrolling physician recorded the clinical suspicion of SBP ("none," "low," "moderate," or "high"), and ascites appearance ("clear," "hazy," "cloudy," or "bloody"). SBP was defined as an absolute neutrophil count ≥ 250 cells/mm(3), or culture pathogen growth. We defined "clear" ascites fluid as negative for SBP, and "hazy," "cloudy," or "bloody" as positive. A physician clinical suspicion of "none" or "low" was considered negative for SBP, and an assessment of "moderate" or "high" was considered positive. The primary outcome measure was sensitivity of physician clinical impression and ascites appearance for SBP. There were 348 cases enrolled, with SBP diagnosed in 43 (12%). Physician clinical suspicion had a sensitivity of 42% (95% confidence interval [CI] 29-55%) for the detection of SBP. Fluid appearance had a sensitivity of 72% (95% CI 58-83%). Physician clinical impression, which included an assessment of fluid appearance, had poor sensitivity for the detection of SBP and cannot be used to exclude the diagnosis. Routine laboratory fluid analysis is indicated after ED paracentesis, even in patients considered to have a low degree of suspicion for SBP. Copyright © 2013 Elsevier Inc. All rights reserved.

Endoscopic ultrasound staging for early esophageal cancer: Are we denying patients neoadjuvant chemo-radiation?

PubMed

Luu, Carrie; Amaral, Marisa; Klapman, Jason; Harris, Cynthia; Almhanna, Khaldoun; Hoffe, Sarah; Frakes, Jessica; Pimiento, Jose M; Fontaine, Jacques P

2017-12-14

To evaluate the accuracy of endoscopic ultrasound (EUS) in early esophageal cancer (EC) performed in a high-volume tertiary cancer center. A retrospective review of patients undergoing esophagectomy was performed and patients with cT1N0 and cT2N0 esophageal cancer by EUS were evaluated. Patient demographics, tumor characteristics, and treatment were reviewed. EUS staging was compared to surgical pathology to determine accuracy of EUS. Descriptive statistics was used to describe the cohort. Student's t test and Fisher's exact test or χ 2 test was used to compare variables. Logistic regression analysis was used to determine if clinical variables such as tumor location and tumor histology were associated with EUS accuracy. Between 2000 and 2015, 139 patients with clinical stageIorIIA esophageal cancer undergoing esophagectomy were identified. There were 25 (18%) female and 114 (82%) male patients. The tumor location included the middle third of the esophagus in 11 (8%) and lower third and gastroesophageal junction in 128 (92%) patients. Ninety-three percent of patients had adenocarcinoma. Preoperative EUS matched the final surgical pathology in 73/139 patients for a concordance rate of 53%. Twenty-nine patients (21%) were under-staged by EUS; of those, 19 (14%) had unrecognized nodal disease. Positron emission tomography (PET) was used in addition to EUS for clinical staging in 62/139 patients. Occult nodal disease was only found in 4 of 62 patients (6%) in whom both EUS and PET were negative for nodal involvement. EUS is less accurate in early EC and endoscopic mucosal resection might be useful in certain settings. The addition of PET to EUS improves staging accuracy.

Microdose Flare-up Gonadotropin-releasing Hormone (GnRH) Agonist Versus GnRH Antagonist Protocols in Poor Ovarian Responders Undergoing Intracytoplasmic Sperm Injection

PubMed Central

Boza, Aysen; Cakar, Erbil; Boza, Barıs; Api, Murat; Kayatas, Semra; Sofuoglu, Kenan

2016-01-01

Background: Microdose flare-up GnRH agonist and GnRH antagonist have become more popular in the management of poor ovarian responders (POR) in recent years; however, the optimal protocol for POR patients undergoing in vitro fertilization has still been a challenge. Methods: In this observational study design, two hundred forty four poor ovarian responders were retrospectively evaluated for their response to GnRH agonist protocol (group-1, n=135) or GnRH antagonist protocol (group-2, n=109). Clinical pregnancy rate was the primary end point and was compared between the groups. Student t-test, Mann Whitney U test and χ2-test were used to compare the groups. The p<0.05 was considered to show a statistically significant result. Results: The mean total gonadotropin doses were 3814±891 IU in group 1 and 3539±877 IU in group 2 (p=0.02). The number of metaphase-II oocytes (3.6±2.4 vs. 2.8±1.9, p=0.005) and implantation rates (27.8% vs. 18.8%, p=0.04) in group 1 and group 2, respectively were significantly different. The fertilization rate in group 1 and group 2 was 73% vs. 68%, respectively (p=0.5) and clinical pregnancy rate was 19.8% vs. 14.4%, respectively (p=0.13). Conclusion: The GnRH agonist microdose flare-up protocol has favorable outcomes with respect to the number of oocytes retrieved and implantation rate; nevertheless, the clinical pregnancy rate was found to be similar in comparison to GnRH antagonist protocol in poor ovarian responders. GnRH antagonist protocol appears to be promising with significantly lower gonadotropin requirement and lower treatment cost in poor ovarian responders. PMID:27478770

Microdose Flare-up Gonadotropin-releasing Hormone (GnRH) Agonist Versus GnRH Antagonist Protocols in Poor Ovarian Responders Undergoing Intracytoplasmic Sperm Injection.

PubMed

Boza, Aysen; Cakar, Erbil; Boza, Barıs; Api, Murat; Kayatas, Semra; Sofuoglu, Kenan

2016-01-01

Microdose flare-up GnRH agonist and GnRH antagonist have become more popular in the management of poor ovarian responders (POR) in recent years; however, the optimal protocol for POR patients undergoing in vitro fertilization has still been a challenge. In this observational study design, two hundred forty four poor ovarian responders were retrospectively evaluated for their response to GnRH agonist protocol (group-1, n=135) or GnRH antagonist protocol (group-2, n=109). Clinical pregnancy rate was the primary end point and was compared between the groups. Student t-test, Mann Whitney U test and χ (2)-test were used to compare the groups. The p<0.05 was considered to show a statistically significant result. The mean total gonadotropin doses were 3814±891 IU in group 1 and 3539±877 IU in group 2 (p=0.02). The number of metaphase-II oocytes (3.6±2.4 vs. 2.8±1.9, p=0.005) and implantation rates (27.8% vs. 18.8%, p=0.04) in group 1 and group 2, respectively were significantly different. The fertilization rate in group 1 and group 2 was 73% vs. 68%, respectively (p=0.5) and clinical pregnancy rate was 19.8% vs. 14.4%, respectively (p=0.13). The GnRH agonist microdose flare-up protocol has favorable outcomes with respect to the number of oocytes retrieved and implantation rate; nevertheless, the clinical pregnancy rate was found to be similar in comparison to GnRH antagonist protocol in poor ovarian responders. GnRH antagonist protocol appears to be promising with significantly lower gonadotropin requirement and lower treatment cost in poor ovarian responders.

46 CFR 178.320 - Intact stability requirements-non-sailing vessels.

Code of Federal Regulations, 2012 CFR

2012-10-01

... following vessels may undergo the simplified stability proof test detailed in § 178.330 of this part, in the... this part, a self-propelled pontoon vessel may undergo the pontoon simplified stability proof test... deck cargo, and is otherwise eligible to undergo the simplified stability proof test detailed in § 178...

46 CFR 178.320 - Intact stability requirements-non-sailing vessels.

Code of Federal Regulations, 2014 CFR

2014-10-01

... following vessels may undergo the simplified stability proof test detailed in § 178.330 of this part, in the... this part, a self-propelled pontoon vessel may undergo the pontoon simplified stability proof test... deck cargo, and is otherwise eligible to undergo the simplified stability proof test detailed in § 178...

46 CFR 178.320 - Intact stability requirements-non-sailing vessels.

Code of Federal Regulations, 2013 CFR

2013-10-01

... following vessels may undergo the simplified stability proof test detailed in § 178.330 of this part, in the... this part, a self-propelled pontoon vessel may undergo the pontoon simplified stability proof test... deck cargo, and is otherwise eligible to undergo the simplified stability proof test detailed in § 178...

Relationship between plethysmographic waveform changes and hemodynamic variables in anesthetized, mechanically ventilated patients undergoing continuous cardiac output monitoring.

PubMed

Thiele, Robert H; Colquhoun, Douglas A; Patrie, James; Nie, Sarah H; Huffmyer, Julie L

2011-12-01

To assess the relation between photoplethysmographically-derived parameters and invasively-determined hemodynamic variables. After induction of anesthesia and placement of a Swan-Ganz CCOmbo catheter, a Nonin OEM III probe was placed on each patient's earlobe. Photoplethysmographic signals were recorded in conjunction with cardiac output. Photoplethysmographic metrics (amplitude of absorbance waveform, maximal slope of absorbance waveform, area under the curve, and width) were calculated offline and compared with invasively determined hemodynamic variables. Subject-specific associations between each dependent and independent variable pair were summarized on a per-subject basis by the nonparametric Spearman rank correlation coefficient. The bias-corrected accelerated bootstrap resampling procedure of Efron and Tibshirani was used to obtain a 95% confidence interval for the median subject-specific correlation coefficient, and Wilcoxon sign-rank tests were conducted to test the null hypothesis that the median of the subject-specific correlation coefficients were equal to 0. University hospital. Eighteen patients undergoing coronary artery bypass graft surgery. Placement of a Swan-Ganz CCOmbo catheter and a Nonin OEM III pulse oximetry probe. There was a positive, statistically significant correlation between stroke volume and width (median correlation coefficient, 0.29; confidence interval, 0.01-0.46; p = 0.034). The concordance between changes in stroke volume and changes in width was 53%. No other correlations achieved statistical significance. This study was unable to reproduce the results of prior studies. Only stroke volume and photoplethysmographic width were correlated in this study; however, the correlation and concordance (based on analysis of a 4-quadrant plot) were too weak to be clinically useful. Future studies in patients undergoing low-to-moderate risk surgery may result in improved correlations and clinical utility. Copyright © 2011 Elsevier Inc. All rights reserved.

The appropriateness of use of percutaneous transluminal coronary angioplasty in Spain.

PubMed

Aguilar, M D; Fitch, K; Lázaro, P; Bernstein, S J

2001-05-01

The rapid increase in the number of percutaneous transluminal coronary angioplasty (PTCA) procedures performed in Spain in recent years raises questions about how appropriately this procedure is being used. To examine this issue, we studied the appropriateness of use of PTCA in Spanish patients and factors associated with inappropriate use. We applied criteria for the appropriate use of PTCA developed by an expert panel of Spanish cardiologists and cardiovascular surgeons to a random sample of 1913 patients undergoing PTCA in Spain in 1997. The patients were selected through a two-step sampling process, stratifying by hospital type (public/private) and volume of procedures (low/medium/high). We examined the association between inappropriate use of PTCA and different clinical and sociodemographic factors. Overall, 46% of the PTCA procedures were appropriate, 31% were uncertain and 22% were inappropriate. Two factors contributing to inappropriate use were patients' receipt of less than optimal medical therapy and their failure to undergo stress testing. Institutional type and volume of procedures were not significantly related with inappropriate use. One of every five PTCA procedures in Spain is done for inappropriate reasons. Assuring that patients receive optimal medical therapy and undergo stress testing when indicated could contribute to more appropriate use of PTCA.

The prevalence of ureaplasma urealyticum, mycoplasma hominis, chlamydia trachomatis and neisseria gonorrhoeae infections, and the rubella status of patients undergoing an initial infertility evaluation

PubMed Central

Imudia, Anthony N.; Detti, Laura; Puscheck, Elizabeth E.; Yelian, Frank D.

2008-01-01

Purpose To determine the prevalence of positive test for Ureaplasma urealyticum (UU), Mycoplasma hominis (MH), Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) infections, and their corresponding Rubella status when undergoing workup for infertility. Methods Retrospective chart review to determine infection status for UU, MH, CT, and NG as determined by cervical swab, as well as the serum Rubella antibody titer. Results A total of 46 patients of the patients reviewed were positive for UU (20.1%), three patients were positive for MH (1.3%), five patients were positive for CT (2.2%) and one patient was positive for NG (0.4%). Rubella immunity was confirmed in 90.3% of patients. Conclusion Approximately one quarter of women presenting to an infertility clinic seeking to conceive were found to have a positive test for UU, MH, CT or NG infection. Additionally, almost 10% of the patients were Rubella non-immune at the time of presentation for infertility evaluation. PMID:18202910

An integrated biochemical prediction model of all-cause mortality in patients undergoing lower extremity bypass surgery for advanced peripheral artery disease

PubMed Central

Owens, Christopher D.; Kim, Ji Min; Hevelone, Nathanael D.; Gasper, Warren J.; Belkin, Michael; Creager, Mark A.; Conte, Michael S.

2012-01-01

Background Patients with advanced peripheral artery disease (PAD) have a high prevalence of cardiovascular (CV) risk factors and shortened life expectancy. However, CV risk factors poorly predict midterm (<5 years) mortality in this population. This study was designed to test the hypothesis that baseline biochemical parameters would add clinically meaningful predictive information in patients undergoing lower extremity bypass. Methods This was a prospective cohort study of subjects with clinically advanced PAD undergoing lower extremity bypass surgery. The Cox proportional hazard was used to assess the main outcome of all-cause mortality. A clinical model was constructed with known cardiovascular risk factors and the incremental value of the addition of clinical chemistry, lipid, and a panel of 11 inflammatory parameters were investigated using c-statistic, the integrated discrimination improvement (IDI) index and Akaike information criterion (AIC). Results 225 subjects were followed for a median 893 days; IQR 539–1315 days). In this study 50 (22.22%) subjects died during the follow-up period. By life table analysis (expressed as percent surviving ± standard error), survival at 1, 2, 3, 4, and 5 years respectively was 90.5 ± 1.9%, 83.4 ± 2.5%, 77.5 ± 3.1%, 71.0 ± 3.8%, and 65.3 ± 6.5%. Compared with survivors, decedents were older, diabetic, had extant CAD, and were more likely to present with CLI as their indication for bypass surgery, P<.05. After adjustment for the above, clinical chemistry and inflammatory parameters significant for all cause mortality were albumin, HR .43 (95% CI .26–.71); P=.001, estimated glomerular filtration rate (eGFR), HR .98 (95% CI .97–.99), P=.023, high sensitivity C-reactive protein (hsCRP), HR 3.21 (95% CI 1.21–8.55), P=.019, and soluble vascular cell adhesion molecule (sVCAM), HR 1.74 (1.04–2.91), P=.034. Of all inflammatory molecules investigated, hsCRP proved most robust and representative of the integrated inflammatory response. Albumin, eGFR, and hsCRP improved the c-statistic and IDI beyond that of the clinical model and produced a final c-statistic of .82. Conclusions A risk prediction model including traditional risk factors and parameters of inflammation, renal function and nutrition had excellent discriminatory ability in predicting all cause mortality in patients with clinically advanced PAD undergoing bypass surgery. PMID:22554422

An integrated biochemical prediction model of all-cause mortality in patients undergoing lower extremity bypass surgery for advanced peripheral artery disease.

PubMed

Owens, Christopher D; Kim, Ji Min; Hevelone, Nathanael D; Gasper, Warren J; Belkin, Michael; Creager, Mark A; Conte, Michael S

2012-09-01

Patients with advanced peripheral artery disease (PAD) have a high prevalence of cardiovascular (CV) risk factors and shortened life expectancy. However, CV risk factors poorly predict midterm (<5 years) mortality in this population. This study tested the hypothesis that baseline biochemical parameters would add clinically meaningful predictive information in patients undergoing lower extremity bypass operations. This was a prospective cohort study of patients with clinically advanced PAD undergoing lower extremity bypass surgery. The Cox proportional hazard model was used to assess the main outcome of all-cause mortality. A clinical model was constructed with known CV risk factors, and the incremental value of the addition of clinical chemistry, lipid assessment, and a panel of 11 inflammatory parameters was investigated using the C statistic, the integrated discrimination improvement index, and Akaike information criterion. The study monitored 225 patients for a median of 893 days (interquartile range, 539-1315 days). In this study, 50 patients (22.22%) died during the follow-up period. By life-table analysis (expressed as percent surviving ± standard error), survival at 1, 2, 3, 4, and 5 years, respectively, was 90.5% ± 1.9%, 83.4% ± 2.5%, 77.5% ± 3.1%, 71.0% ± 3.8%, and 65.3% ± 6.5%. Compared with survivors, decedents were older, diabetic, had extant coronary artery disease, and were more likely to present with critical limb ischemia as their indication for bypass surgery (P < .05). After adjustment for the above, clinical chemistry and inflammatory parameters significant (hazard ratio [95% confidence interval]) for all-cause mortality were albumin (0.43 [0.26-0.71]; P = .001), estimated glomerular filtration rate (0.98 [0.97-0.99]; P = .023), high-sensitivity C-reactive protein (hsCRP; 3.21 [1.21-8.55]; P = .019), and soluble vascular cell adhesion molecule (1.74 [1.04-2.91]; P = .034). Of the inflammatory molecules investigated, hsCRP proved most robust and representative of the integrated inflammatory response. Albumin, eGFR, and hsCRP improved the C statistic and integrated discrimination improvement index beyond that of the clinical model and produced a final C statistic of 0.82. A risk prediction model including traditional risk factors and parameters of inflammation, renal function, and nutrition had excellent discriminatory ability in predicting all-cause mortality in patients with clinically advanced PAD undergoing bypass surgery. Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Attitudes toward direct-to-consumer advertisements and online genetic testing among high-risk women participating in a hereditary cancer clinic.

PubMed

Perez, Giselle K; Cruess, Dean G; Cruess, Stacy; Brewer, Molly; Stroop, Jennifer; Schwartz, Robin; Greenstein, Robert

2011-07-01

Genetic testing for the breast cancer genes 1/2 (BRCA 1/2) has helped women determine their risk of developing breast and ovarian cancer. As interest in genetic testing has grown, companies have created strategies to disseminate information about testing, including direct-to-consumer advertising (DTCA) and online genetic testing. This study examined attitudes toward DTCA and online testing for BRCA among 84 women at a high-risk clinic as well as additional factors that may be associated with these attitudes, such as personal and familial cancer history, cancer worry and risk perception, and history with genetic testing/counseling. Results showed that the majority of the women held favorable attitudes toward DTCA for BRCA testing but did not support online testing. Factors such as familial ovarian cancer, cancer worry, and satisfaction with genetic counseling/testing were associated with positive attitudes toward DTCA, whereas personal breast cancer history was related to negative attitudes. The findings suggest that women may view DTCA as informational but rely on physicians for help in their decision to undergo testing, and also suggest that cancer history may affect women's acceptance of DTCA and genetic testing.

A randomized-controlled trial examining the effects of reflexology on anxiety of patients undergoing coronary angiography.

PubMed

Molavi Vardanjani, Mehdi; Masoudi Alavi, Negin; Razavi, Narges Sadat; Aghajani, Mohammad; Azizi-Fini, Esmail; Vaghefi, Seied Morteza

2013-09-01

The anxiety reduction before coronary angiography has clinical advantages and is one of the objectives of nursing. Reflexology is a non-invasive method that has been used in several clinical situations. Applying reflexology might have effect on the reduction of anxiety before coronary angiography. The aim of this randomized clinical trial was to investigate the effect of reflexology on anxiety among patients undergoing coronary angiography. This trial was conducted in Shahid Beheshti Hospital, in Kashan, Iran. One hundred male patients who were undergoing coronary angiography were randomly enrolled into intervention and placebo groups. The intervention protocol was included 30 minutes of general foot massage and the stimulation of three reflex points including solar plexus, pituitary gland, and heart. The placebo group only received the general foot massage. Spielbergers state trait anxiety inventory was used to assess the anxiety experienced by patients. Data was analyzed using Man-Witney, Wilcoxon and Chi-square tests. The stepwise multiple regressions used to analyze the variables that are involved in anxiety reduction. The mean range of anxiety decreased from 53.24 to 45.24 in reflexology group which represented 8 score reduction (P = 0.0001). The reduction in anxiety was 5.9 score in placebo group which was also significant (P = 0.0001). The anxiety reduction was significantly higher in reflexology group (P = 0.014). The stepwise multiple regression analysis showed that doing reflexology can explain the 7.5% of anxiety reduction which made a significant model. Reflexology can decrease the anxiety level before coronary angiography. Therefore, reflexology before coronary angiography is recommended.

Cognitive compensatory processes of older, clinically fit patients with hematologic malignancies undergoing chemotherapy: A longitudinal cohort study.

PubMed

Libert, Yves; Borghgraef, Cindy; Beguin, Yves; Delvaux, Nicole; Devos, Martine; Doyen, Chantal; Dubruille, Stéphanie; Etienne, Anne-Marie; Liénard, Aurore; Merckaert, Isabelle; Reynaert, Christine; Slachmuylder, Jean-Louis; Straetmans, Nicole; Van Den Neste, Eric; Bron, Dominique; Razavi, Darius

2017-12-01

Despite the well-known negative impacts of cancer and anticancer therapies on cognitive performance, little is known about the cognitive compensatory processes of older patients with cancer. This study was designed to investigate the cognitive compensatory processes of older, clinically fit patients with hematologic malignancies undergoing chemotherapy. We assessed 89 consecutive patients (age ≥ 65 y) without severe cognitive impairment and 89 age-, sex-, and education level-matched healthy controls. Cognitive compensatory processes were investigated by (1) comparing cognitive performance of patients and healthy controls in novel (first exposure to cognitive tasks) and non-novel (second exposure to the same cognitive tasks) contexts, and (2) assessing psychological factors that may facilitate or inhibit cognitive performance, such as motivation, psychological distress, and perceived cognitive performance. We assessed cognitive performance with the Trail-Making, Digit Span and FCSR-IR tests, psychological distress with the Hospital Anxiety and Depression Scale, and perceived cognitive performance with the FACT-Cog questionnaire. In novel and non-novel contexts, average cognitive performances of healthy controls were higher than those of patients and were associated with motivation. Cognitive performance of patients was not associated with investigated psychological factors in the novel context but was associated with motivation and psychological distress in the non-novel context. Older, clinically fit patients with hematologic malignancies undergoing chemotherapy demonstrated lower cognitive compensatory processes compared to healthy controls. Reducing distress and increasing motivation may improve cognitive compensatory processes of patients in non-novel contexts. Copyright © 2017 John Wiley & Sons, Ltd.

Clinical application of spectral electromagnetic interaction in breast cancer: diagnostic results of a pilot study.

PubMed

De Cicco, Concetta; Mariani, Luigi; Vedruccio, Clarbruno; Ricci, Carla; Balma, Massimo; Rotmensz, Nicole; Ferrari, Mahila Esmeralda; Autino, Elena; Trifirò, Giuseppe; Sacchini, Virgilio; Viale, Giuseppe; Paganelli, Giovanni

2006-01-01

There is a need for a cost-effective method to safely reduce the number of diagnostic procedures women undergo for breast cancer. We tested a new procedure for breast cancer diagnosis based on breast tissue response to low level electromagnetic incident waves. We tested 101 patients with suspicious palpable breast lesions detected by mammography or ultrasonography, who were scheduled to undergo an open biopsy. Using an electromagnetic field generator (tissue resonance interaction method probe [TRIMprob]), we passed the TRIMprob over the breast area and recorded the signal variation of one or more spectral lines (dB1, dB2, dB3). The results were compared with those of a control group as well as with pathology data obtained from excisional biopsy. No adverse effects of the test were observed. Pathology revealed 86 malignant breast cancers (72 invasive, 14 in situ) and 15 benign conditions. We achieved the best discrimination between normal breasts and lesions using dB1 (dB1 AUC-ROC = 0.8; dB2 AUC-ROC = 0.61; dB3 AUC-ROC = 0.76). With a specificity of 75% to 95%, the sensitivity ranged from 49% to 84%. Tumor or patient variables did not influence the results. The TRIMprob test was able to provide some degree of discrimination between normal breast tissue and lesions but not between benign and malignant lesions. The lack of influence of patient age and tumor size on test results might be advantageous in terms of early diagnosis in young women. These preliminary results need to be verified and extended in a preclinical-stage disease setting before clinical applicability can be envisaged.

Men's body mass index in relation to embryo quality and clinical outcomes in couples undergoing in vitro fertilization.

PubMed

Colaci, Daniela S; Afeiche, Myriam; Gaskins, Audrey J; Wright, Diane L; Toth, Thomas L; Tanrikut, Cigdem; Hauser, Russ; Chavarro, Jorge E

2012-11-01

To evaluate the association between men's body mass index (BMI), early embryo quality, and clinical outcomes in couples undergoing in vitro fertilization (IVF). Prospective cohort study. Fertility clinic in an academic medical center. 114 couples who underwent 172 assisted reproduction cycles. None. Fertilization rate, embryo quality, implantation rate, clinical pregnancy rate, and live birth rate. The fertilization rate was higher among obese men than among normal weight men in conventional IVF cycles. No statistically significant associations were found between men's BMI and the proportion of poor-quality embryos on day 3, slow embryo cleavage rate, or accelerated embryo cleavage rate. Men's BMI was unrelated to positive β-human chorionic gonadotropin rate, clinical pregnancy rate, or live-birth rate per embryo transfer. Among couples undergoing intracytoplasmic sperm injection, the odds of live birth in couples with obese male partners was 84% lower than the odds in couples with men with normal BMI. Our data suggest a possible deleterious effect of male obesity on the odds of having a live birth among couples undergoing intracytoplasmic sperm injection. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Fluorescence In Situ Hybridization Probe Validation for Clinical Use.

PubMed

Gu, Jun; Smith, Janice L; Dowling, Patricia K

2017-01-01

In this chapter, we provide a systematic overview of the published guidelines and validation procedures for fluorescence in situ hybridization (FISH) probes for clinical diagnostic use. FISH probes-which are classified as molecular probes or analyte-specific reagents (ASRs)-have been extensively used in vitro for both clinical diagnosis and research. Most commercially available FISH probes in the United States are strictly regulated by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) the Clinical Laboratory Improvement Amendments (CLIA), and the College of American Pathologists (CAP). Although home-brewed FISH probes-defined as probes made in-house or acquired from a source that does not supply them to other laboratories-are not regulated by these agencies, they too must undergo the same individual validation process prior to clinical use as their commercial counterparts. Validation of a FISH probe involves initial validation and ongoing verification of the test system. Initial validation includes assessment of a probe's technical specifications, establishment of its standard operational procedure (SOP), determination of its clinical sensitivity and specificity, development of its cutoff, baseline, and normal reference ranges, gathering of analytics, confirmation of its applicability to a specific research or clinical setting, testing of samples with or without the abnormalities that the probe is meant to detect, staff training, and report building. Ongoing verification of the test system involves testing additional normal and abnormal samples using the same method employed during the initial validation of the probe.

Comparison of Flow and Volume Incentive Spirometry on Pulmonary Function and Exercise Tolerance in Open Abdominal Surgery: A Randomized Clinical Trial.

PubMed

Kumar, Amaravadi Sampath; Alaparthi, Gopala Krishna; Augustine, Alfred Joseph; Pazhyaottayil, Zulfeequer Chundaanveetil; Ramakrishna, Anand; Krishnakumar, Shyam Krishnan

2016-01-01

Surgical procedures in abdominal area lead to changes in pulmonary function, respiratory mechanics and impaired physical capacity leading to postoperative pulmonary complications, which can affect up to 80% of upper abdominal surgery. To evaluate the effects of flow and volume incentive spirometry on pulmonary function and exercise tolerance in patients undergoing open abdominal surgery. A randomized clinical trial was conducted in a hospital of Mangalore city in Southern India. Thirty-seven males and thirteen females who were undergoing abdominal surgeries were included and allocated into flow and volume incentive spirometry groups by block randomization. All subjects underwent evaluations of pulmonary function with measurement of Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), Peak Expiratory Flow (PEF). Preoperative and postoperative measurements were taken up to day 5 for both groups. Exercise tolerance measured by Six- Minute Walk Test during preoperative period and measured again at the time of discharge for both groups. Pulmonary function was analysed by post-hoc analysis and carried out using Bonferroni's 't'-test. Exercise tolerance was analysed by Paired 'T'-test. Pulmonary function (FVC, FEV1, and PEFR) was found to be significantly decreased in 1(st), 2(nd) and 3(rd) postoperative day when compared with preoperative day. On 4(th) and 5(th) postoperative day the pulmonary function (FVC, FEV1, and PEFR) was found to be better preserved in both flow and volume incentive spirometry groups. The Six-Minute Walk Test showed a statistically significant improvement in pulmonary function on the day of discharge than in the preoperative period. In terms of distance covered, the volume- incentive spirometry group showed a greater statistically significant improvement from the preoperative period to the time of discharge than was exhibited by the flow incentive spirometry group. Flow and volume incentive spirometry can be safely recommended to patients undergoing open abdominal surgery as there have been no adverse events recorded. Also, these led to a demonstrable improvement in pulmonary function and exercise tolerance.

Comparison of Flow and Volume Incentive Spirometry on Pulmonary Function and Exercise Tolerance in Open Abdominal Surgery: A Randomized Clinical Trial

PubMed Central

Kumar, Amaravadi Sampath; Augustine, Alfred Joseph; Pazhyaottayil, Zulfeequer Chundaanveetil; Ramakrishna, Anand; Krishnakumar, Shyam Krishnan

2016-01-01

Introduction Surgical procedures in abdominal area lead to changes in pulmonary function, respiratory mechanics and impaired physical capacity leading to postoperative pulmonary complications, which can affect up to 80% of upper abdominal surgery. Aim To evaluate the effects of flow and volume incentive spirometry on pulmonary function and exercise tolerance in patients undergoing open abdominal surgery. Materials and Methods A randomized clinical trial was conducted in a hospital of Mangalore city in Southern India. Thirty-seven males and thirteen females who were undergoing abdominal surgeries were included and allocated into flow and volume incentive spirometry groups by block randomization. All subjects underwent evaluations of pulmonary function with measurement of Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), Peak Expiratory Flow (PEF). Preoperative and postoperative measurements were taken up to day 5 for both groups. Exercise tolerance measured by Six- Minute Walk Test during preoperative period and measured again at the time of discharge for both groups. Pulmonary function was analysed by post-hoc analysis and carried out using Bonferroni’s ‘t’-test. Exercise tolerance was analysed by Paired ‘T’-test. Results Pulmonary function (FVC, FEV1, and PEFR) was found to be significantly decreased in 1st, 2nd and 3rd postoperative day when compared with preoperative day. On 4th and 5th postoperative day the pulmonary function (FVC, FEV1, and PEFR) was found to be better preserved in both flow and volume incentive spirometry groups. The Six-Minute Walk Test showed a statistically significant improvement in pulmonary function on the day of discharge than in the preoperative period. In terms of distance covered, the volume- incentive spirometry group showed a greater statistically significant improvement from the preoperative period to the time of discharge than was exhibited by the flow incentive spirometry group. Conclusion Flow and volume incentive spirometry can be safely recommended to patients undergoing open abdominal surgery as there have been no adverse events recorded. Also, these led to a demonstrable improvement in pulmonary function and exercise tolerance. PMID:26894090

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.

Attitudes towards personal genomics among older Swiss adults: An exploratory study

PubMed Central

Mählmann, Laura; Röcke, Christina; Brand, Angela; Hafen, Ernst; Vayena, Effy

2016-01-01

Objectives To explore attitudes of Swiss older adults towards personal genomics (PG). Methods Using an anonymized voluntary paper-and-pencil survey, data were collected from 151 men and women aged 60–89 years attending the Seniorenuniversität Zurich, Switzerland (Seniors' University). Analyses were conducted using descriptive and inferential statistics. Results One third of the respondents were aware of PG, and more than half indicated interest in undergoing PG testing. The primary motivation provided was respondents' interest in finding out about their own disease risk, followed by willingness to contribute to scientific research. Forty-four percent were not interested in undergoing testing because results might be worrisome, or due to concerns about the validity of the results. Only a minority of respondents mentioned privacy-related concerns. Further, 66% were interested in undergoing clinic-based PG motivated by the opportunity to contribute to scientific research (78%) and 75% of all study participants indicated strong preferences to donate genomic data to public research institutions. Conclusion This study indicates a relatively positive overall attitude towards personal genomic testing among older Swiss adults, a group not typically represented in surveys about personal genomics. Genomic data of older adults can be highly relevant to late life health and maintenance of quality of life. In addition they can be an invaluable source for better understanding of longevity, health and disease. Understanding the attitudes of this population towards genomic analyses, although important, remains under-examined. PMID:27047754

Viscoelastic blood coagulation measurement with Sonoclot predicts postoperative bleeding in cardiac surgery after heparin reversal.

PubMed

Bischof, Dominique B; Ganter, Michael T; Shore-Lesserson, Linda; Hartnack, Sonja; Klaghofer, Richard; Graves, Kirk; Genoni, Michele; Hofer, Christoph K

2015-01-01

The aim of the study was to determine if Sonoclot with its sensitive glass bead-activated, viscoelastic test can predict postoperative bleeding in patients undergoing cardiac surgery at predefined time points. A prospective, observational clinical study. A teaching hospital, single center. Consecutive patients undergoing cardiac surgery (N = 300). Besides routine laboratory coagulation studies and heparin management with standard (kaolin) activated clotting time, additional native blood samples were analyzed on a Sonoclot using glass bead-activated tests. Glass bead-activated clotting time, clot rate, and platelet function were recorded immediately before anesthesia induction and at the end of surgery after heparin reversal but before chest closure. Primary outcome was postoperative blood loss (chest tube drainage at 4, 8, and 12 hours postoperatively). Secondary outcome parameters were transfusion requirements, need for surgical re-exploration, time of mechanical ventilation, length of intensive care unit and hospital stay, and hospital morbidity and mortality. Patients were categorized into "bleeders" and "nonbleeders." Patient characteristics, operations, preoperative standard laboratory parameters, and procedural times were comparable between bleeders and nonbleeders except for sex and age. Bleeders had higher rates of transfusions, surgical re-explorations, and complications. Only glass bead measurements by Sonoclot after heparin reversal before chest closure but not preoperatively were predictive for increased postoperative bleeding. Sonoclot with its glass bead-activated tests may predict the risk for postoperative bleeding in patients undergoing cardiac surgery at the end of surgery after heparin reversal but before chest closure. Copyright © 2015 Elsevier Inc. All rights reserved.

A Medical Area Network of Virtual Technology (MANVT)

DTIC Science & Technology

2011-10-01

translational research projects be captured, undergo quality control and are stored/managed in such a way that they can be mined to test and generate new...translational research is that access to detailed clinical data typically requires proper informed consent and IRB approval; however, in order to design ...attributes of interest at an early stage of the process. 12B2 overcomes these challenges by enabling researchers to design and execute queries

Evaluation of computer-generated guidelines for companions of paediatric patients undergoing chemotherapy.

PubMed

Lopes, Vagner José; Shmeil, Marcos Augusto Hochuli

2017-04-27

To compare computer-generated guidelines with and without the use of a Clinical Decision Support System - Oncology Care and Healthcare for Chemotherapy Patients, for the caregivers of children undergoing chemotherapy. This is a descriptive, evaluative, and quantitative study conducted at a paediatrics hospital in Curitiba, Paraná, Brazil, from December 2015 to January 2016. The sample consisted of 58 participants divided into two groups: Group 1, without the aid of software, and Group 2, with the aid of the software. The data were analysed using the Mann-Whitney U test. The guidelines revealed a statistical significance (p<0.05), with a prevalence of a higher concordance average in Group 2 in comparison with Group 1. Computer-generated guidelines are a valuable qualitative support tool for nurses.

The Influence of Cardiac Risk Factor Burden on Cardiac Stress Test Outcomes.

PubMed

Schrock, Jon W; Li, Morgan; Orazulike, Chidubem; Emerman, Charles L

2011-06-01

Chest pain is the most common admission diagnosis for observation unit patients. These patients often undergo cardiac stress testing to further risk stratify for coronary artery disease (CAD). The decision of whom to stress is currently based on clinical judgment. We sought to determine the influence of cardiac risk factor burden on cardiac stress test outcome for patients tested from an observation unit, inpatient or outpatient setting. We performed a retrospective observational cohort study for all patients undergoing stress testing in our institution from June 2006 through July 2007. Cardiac risk factors were collected at the time of stress testing. Risk factors were evaluated in a summative fashion using multivariate regression adjusting for age and known coronary artery disease. The model was tested for goodness of fit and collinearity and the c statistic was calculated using the receiver operating curve. A total of 4026 subjects were included for analysis of which 22% had known CAD. The rates of positive outcome were 89 (12.0%), 95 (12.6%), and 343 (16.9%) for the OU, outpatients, and hospitalized patients respectively. While the odds of a positive test outcome increased for additional cardiac risk factors, ROC curve analysis indicates that simply adding the number of risk factors does not add significant diagnostic value. Hospitalized patients were more likely to have a positive stress test, OR 1.41 (1.10 - 1.81). Our study does not support basing the decision to perform a stress test on the number of cardiac risk factors.

Enter the reverend: introduction to and application of Bayes' theorem in clinical ophthalmology.

PubMed

Thomas, Ravi; Mengersen, Kerrie; Parikh, Rajul S; Walland, Mark J; Muliyil, Jayprakash

2011-12-01

Ophthalmic practice utilizes numerous diagnostic tests, some of which are used to screen for disease. Interpretation of test results and many clinical management issues are actually problems in inverse probability that can be solved using Bayes' theorem. Use two-by-two tables to understand Bayes' theorem and apply it to clinical examples. Specific examples of the utility of Bayes' theorem in diagnosis and management. Two-by-two tables are used to introduce concepts and understand the theorem. The application in interpretation of diagnostic tests is explained. Clinical examples demonstrate its potential use in making management decisions. Positive predictive value and conditional probability. The theorem demonstrates the futility of testing when prior probability of disease is low. Application to untreated ocular hypertension demonstrates that the estimate of glaucomatous optic neuropathy is similar to that obtained from the Ocular Hypertension Treatment Study. Similar calculations are used to predict the risk of acute angle closure in a primary angle closure suspect, the risk of pupillary block in a diabetic undergoing cataract surgery, and the probability that an observed decrease in intraocular pressure is due to the medication that has been started. The examples demonstrate how data required for management can at times be easily obtained from available information. Knowledge of Bayes' theorem helps in interpreting test results and supports the clinical teaching that testing for conditions with a low prevalence has a poor predictive value. In some clinical situations Bayes' theorem can be used to calculate vital data required for patient management. © 2011 The Authors. Clinical and Experimental Ophthalmology © 2011 Royal Australian and New Zealand College of Ophthalmologists.

Comparison among the efficacy of interventions for the return rate to receive the pap test report: randomized controlled clinical trial 1

PubMed Central

Vasconcelos, Camila Teixeira Moreira; Pinheiro, Ana Karina Bezerra; Nicolau, Ana Izabel Oliveira; Lima, Thaís Marques; Barbosa, Denise de Fátima Fernandes

2017-01-01

ABSTRACT Objective: to test the effects of a behavioral, an educative and a comparative intervention on women's adherence to the return appointment to receive the pap test report. Methods: randomized controlled clinical trial at a Primary Health Care Service, involving three groups: EG (educative session and test demonstration), BG (recall ribbon) and standard intervention (card containing the return appointment - graphical reminder), called comparative group here (CG). To select the sample, the following was established: having started sexual activity and undergoing the pap smear during the study, resulting in 775 women. Results: among the 775 women, 585 (75.5%) returned to receive the test result within 65 days. The educative group presented the highest return rate (EG=82%/CG=77%/BG=66%), statistically significant only when compared to the behavioral group (p=0.000). The educative group obtained the smallest interval (p<0.05) concerning the mean number of days of return to receive the test result (EG:M=43days/BG:M=47.5days/CG:M=44.8 days). Conclusion: the educative group reached higher return rates and the women returned earlier, but the behavioral intervention showed to be the least effective. Brazilian Clinical Trial Register: RBR-93ykhs. PMID:28301035

Clinical germline diagnostic exome sequencing for hereditary cancer: Findings within novel candidate genes are prevalent.

PubMed

Powis, Zöe; Espenschied, Carin R; LaDuca, Holly; Hagman, Kelly D; Paudyal, Tripti; Li, Shuwei; Inaba, Hiroto; Mauer, Ann; Nathanson, Katherine L; Knost, James; Chao, Elizabeth C; Tang, Sha

2018-08-01

Clinical diagnostic exome sequencing (DES) has been effective in diagnosing individuals with suspected genetic conditions; nevertheless little has been described regarding its clinical utility in individuals with a personal and family history of cancer. This study aimed to assess diagnostic yield and clinical characteristics of pediatric and adult patients undergoing germline DES for hereditary cancer. We retrospectively reviewed 2171 patients referred for DES; cases with a personal and/or family history of cancer were further studied. Of 39 cancer patients, relevant alterations were found in eight individuals (21%), including one (3%) positive pathogenic alteration within a characterized gene, two (5%) uncertain findings in characterized genes, and five (13%) alterations in novel candidate genes. Two of the 5 pediatric patients, undergoing testing, (40%) had findings in novel candidate genes, with the remainder being negative. We include brief case studies to illustrate the variety of challenging issues related to these patients. Our observations demonstrate utility of family-based exome sequencing in patients for suspected hereditary cancer, including familial co-segregation analysis, and comprehensive medical review. DES may be particularly useful when traditional approaches do not result in a diagnosis or in families with unique phenotypes. This work also highlights the importance and complexity of analysis of uncharacterized genes in exome sequencing for hereditary cancer. Copyright © 2018 Elsevier Inc. All rights reserved.

Problem-based learning versus a traditional educational methodology: a comparison of preclinical and clinical periodontics performance.

PubMed

Rich, Sandra K; Keim, Robert G; Shuler, Charles F

2005-06-01

To evaluate efficacy of a problem-based learning (PBL) pedagogy in preclinical and clinical teaching, test scores of 234 undergraduate dental students from the conventionally taught classes of 2003 and 2004 were compared with scores of 274 dental students from the PBL classes of 2005 and 2006. Although the groups' means were close together, t-test analysis of scores revealed that PBL students performed significantly better than traditional (TRAD) students on midterm (p=.0001) and final (p=.015) examinations taken on student partner/mock patients. ANOVA comparing the classes with each other showed significant differences for the midterm and final, but not for the clinical examination. Further multiple comparison tests (Tukey HSD) for the midterm and final revealed that differences specifically reflected superior performance of PBL classes against one of the TRAD classes (2004). There was no difference in performance between PBL (n=134) and TRAD (n=233) students on examinations taken with actual clinical patients who were undergoing nonsurgical periodontal treatment. Over a two-year period, PBL students rated their program instructors at a mean of 4.41 on a Likert-type scale of 1 (not helpful) to 5 (outstanding). The program provides a PBL model for teaching preclinical and clinical skills supported by a four-year evaluation of manual skills outcomes.

Development and validation of a brief screening instrument for psychosocial risk associated with genetic testing: a pan-Canadian cohort study

PubMed Central

Esplen, Mary Jane; Cappelli, Mario; Wong, Jiahui; Bottorff, Joan L; Hunter, Jon; Carroll, June; Dorval, Michel; Wilson, Brenda; Allanson, Judith; Semotiuk, Kara; Aronson, Melyssa; Bordeleau, Louise; Charlemagne, Nicole; Meschino, Wendy

2013-01-01

Objectives To develop a brief, reliable and valid instrument to screen psychosocial risk among those who are undergoing genetic testing for Adult-Onset Hereditary Disease (AOHD). Design A prospective two-phase cohort study. Setting 5 genetic testing centres for AOHD, such as cancer, Huntington's disease or haemochromatosis, in ambulatory clinics of tertiary hospitals across Canada. Participants 141 individuals undergoing genetic testing were approached and consented to the instrument development phase of the study (Phase I). The Genetic Psychosocial Risk Instrument (GPRI) developed in Phase I was tested in Phase II for item refinement and validation. A separate cohort of 722 individuals consented to the study, 712 completed the baseline package and 463 completed all follow-up assessments. Most participants were female, at the mid-life stage. Individuals in advanced stages of the illness or with cognitive impairment or a language barrier were excluded. Interventions Phase I: GPRI items were generated from (1) a review of the literature, (2) input from genetic counsellors and (3) phase I participants. Phase II: further item refinement and validation were conducted with a second cohort of participants who completed the GPRI at baseline and were followed for psychological distress 1-month postgenetic testing results. Primary and secondary outcome measures GPRI, Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Brief Symptom Inventory (BSI) and Impact of Event Scale (IES). Results The final 20-item GPRI had a high reliability—Cronbach's α at 0.81. The construct validity was supported by high correlations between GPRI and BSI and IES. The predictive value was demonstrated by a receiver operating characteristic curve of 0.78 plotting GPRI against follow-up assessments using HAM-D and HAM-A. Conclusions With a cut-off score of 50, GPRI identified 84% of participants who displayed distress postgenetic testing results, supporting its potential usefulness in a clinical setting. PMID:23485718

Anesthesia Preoperative Clinic Referral for Elevated Hba1c Reduces Complication Rate in Diabetic Patients Undergoing Total Joint Arthroplasty.

PubMed

Kallio, Peter J; Nolan, Jenea; Olsen, Amy C; Breakwell, Susan; Topp, Richard; Pagel, Paul S

2015-06-01

Diabetes mellitus (DM) is risk factor for complications after orthopedic surgery. We tested the hypothesis that anesthesia preoperative clinic (APC) referral for elevated glycosylated hemoglobin (HbA1c) reduces complication rate after total joint arthroplasty (TJA). Patients (n = 203) with and without DM were chosen from 1,237 patients undergoing TJA during 2006 - 12. Patients evaluated in the APC had surgery in 2006 - 8 regardless of HbA1c (uncontrolled). Those evaluated between in subsequent two-year intervals were referred to primary care for HbA1c ≥ 10% and ≥ 8%, respectively, to improve DM control before surgery. Complications and mortality were quantified postoperatively and at three, six, and twelve months. Length of stay (LOS) and patients requiring a prolonged LOS (> 5 days) were recorded. Patients (197 men, 6 women) underwent 71, 131, and 1 total hip, knee, and shoulder replacements, respectively. Patients undergoing TJA with uncontrolled HbA1c and those with HbA1c < 10%, but not those with HbA1c < 8%, had a higher incidence of coronary disease and hypercholesterolemia than patients without DM. An increase in complication rate was observed in DM patients with uncontrolled HbA1c versus patients without DM (P < 0.001); the complication rate progressively decreased with tighter HbA1c control. More DM patients with preoperative HbA1c that was uncontrolled or ≥ 10% required prolonged LOS versus those without DM (P < 0.001 and P = 0.0404, respectively). APC referral for elevated HbA1c reduces complication rate and the incidence of prolonged hospitalization during the first year after surgery in diabetics undergoing TJA.

Safety and feasibility of xenon as an adjuvant to sevoflurane anaesthesia in children undergoing interventional or diagnostic cardiac catheterization: study protocol for a randomised controlled trial.

PubMed

Devroe, Sarah; Lemiere, Jurgen; Van de Velde, Marc; Gewillig, Marc; Boshoff, Derize; Rex, Steffen

2015-03-04

Xenon has minimal haemodynamic side effects when compared to volatile or intravenous anaesthetics. Moreover, in in vitro and in animal experiments, xenon has been demonstrated to convey cardio- and neuroprotective effects. Neuroprotection could be advantageous in paediatric anaesthesia as there is growing concern, based on both laboratory studies and retrospective human clinical studies, that anaesthetics may trigger an injury in the developing brain, resulting in long-lasting neurodevelopmental consequences. Furthermore, xenon-mediated neuroprotection could help to prevent emergence delirium/agitation. Altogether, the beneficial haemodynamic profile combined with its putative organ-protective properties could render xenon an attractive option for anaesthesia of children undergoing cardiac catheterization. In a phase-II, mono-centre, prospective, single-blind, randomised, controlled study, we will test the hypothesis that the administration of 50% xenon as an adjuvant to general anaesthesia with sevoflurane in children undergoing elective cardiac catheterization is safe and feasible. Secondary aims include the evaluation of haemodynamic parameters during and after the procedure, emergence characteristics, and the analysis of peri-operative neuro-cognitive function. A total of 40 children ages 4 to 12 years will be recruited and randomised into two study groups, receiving either a combination of sevoflurane and xenon or sevoflurane alone. Children undergoing diagnostic or interventional cardiac catheterization are a vulnerable patient population, one particularly at risk for intra-procedural haemodynamic instability. Xenon provides remarkable haemodynamic stability and potentially has cardio- and neuroprotective properties. Unfortunately, evidence is scarce on the use of xenon in the paediatric population. Our pilot study will therefore deliver important data required for prospective future clinical trials. EudraCT: 2014-002510-23 (5 September 2014).

Evaluation of the AJCC 8th Edition Staging System for Pathologically Versus Clinically Staged Intrahepatic Cholangiocarcinoma (iCCA): a Time to Revisit a Dogma? A Surveillance, Epidemiology, and End Results (SEER) Analysis.

PubMed

Kamarajah, Sivesh K

2018-03-07

Recently, the AJCC has released its 8th edition changes to the staging system for intrahepatic cholangiocarcinoma (iCCA). This study sought to validate the proposed changes to the 8th edition of AJCC system for T and N classification of iCCA using a population-based data set. Using the Surveillance, Epidemiology, and End Results (SEER) database (1998-2013), patients undergoing resection or non-surgical management for non-metastatic iCCA were identified. Overall survival was estimated using the Kaplan-Meier method and compared using log-rank tests. Concordance indices (c-indices) calculated from Cox proportional hazards models were calculated to evaluate discriminatory power. The study included 2630 patients resected (37%) or non-surgically managed (63%) for iCCA. Nodal staging was performed in 56%, of whom 31% had positive nodes. For all patients with iCCA, the median 5-year survival by AJCC T classification for T1a, T1b, T2, T3, and T4 was 32, 21, 14, 10, and 10 months, respectively (p < 0.001). The concordance index for the staging system was 0.57 for all patients, 0.62 for those who underwent resection, and 0.54 for patients who did not undergo resection. In summary, the new AJCC 8th edition staging system is comparable to the 7th edition and valid in stratifying patients with iCCA. However, the performance of the staging system is better in patients undergoing surgical resection than those undergoing non-surgical management. These findings further highlight the need for improved accuracy of radiological imaging in clinically staging patients to guide prognosis.

Effectiveness of diagnostic strategies in suspected delayed cerebral ischemia: a decision analysis.

PubMed

Rawal, Sapna; Barnett, Carolina; John-Baptiste, Ava; Thein, Hla-Hla; Krings, Timo; Rinkel, Gabriel J E

2015-01-01

Delayed cerebral ischemia (DCI) is a serious complication after aneurysmal subarachnoid hemorrhage. If DCI is suspected clinically, imaging methods designed to detect angiographic vasospasm or regional hypoperfusion are often used before instituting therapy. Uncertainty in the strength of the relationship between imaged vasospasm or perfusion deficits and DCI-related outcomes raises the question of whether imaging to select patients for therapy improves outcomes in clinical DCI. Decision analysis was performed using Markov models. Strategies were either to treat all patients immediately or to first undergo diagnostic testing by digital subtraction angiography or computed tomography angiography to assess for angiographic vasospasm, or computed tomography perfusion to assess for perfusion deficits. According to current practice guidelines, treatment consisted of induced hypertension. Outcomes were survival in terms of life-years and quality-adjusted life-years. When treatment was assumed to be ineffective in nonvasospasm patients, Treat All and digital subtraction angiography were equivalent strategies; when a moderate treatment effect was assumed in nonvasospasm patients, Treat All became the superior strategy. Treating all patients was also superior to selecting patients for treatment via computed tomography perfusion. One-way sensitivity analyses demonstrated that the models were robust; 2- and 3-way sensitivity analyses with variation of disease and treatment parameters reinforced dominance of the Treat All strategy. Imaging studies to test for the presence of angiographic vasospasm or perfusion deficits in patients with clinical DCI do not seem helpful in selecting which patients should undergo treatment and may not improve outcomes. Future directions include validating these results in prospective cohort studies. © 2014 American Heart Association, Inc.

Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery.

PubMed

Warner, Matthew A; Welsby, Ian J; Norris, Phillip J; Silliman, Christopher C; Armour, Sarah; Wittwer, Erica D; Santrach, Paula J; Meade, Laurie A; Liedl, Lavonne M; Nieuwenkamp, Chelsea M; Douthit, Brian; van Buskirk, Camille M; Schulte, Phillip J; Carter, Rickey E; Kor, Daryl J

2017-08-18

The transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care (POC) washing of allogeneic RBCs may remove these BRMs, thereby mitigating their impact on post-transfusion respiratory complications. This is a multicenter randomised clinical trial of standard allogeneic versus washed allogeneic RBC transfusion for adult patients undergoing cardiac surgery testing the hypothesis that POC RBC washing is feasible, safe, and efficacious and will reduce recipient immune and physiologic responses associated with transfusion-related respiratory complications. Relevant clinical outcomes will also be assessed. This investigation will enrol 170 patients at two hospitals in the USA. Simon's two-stage design will be used to assess the feasibility of POC RBC washing. The primary safety outcomes will be assessed using Wilcoxon Rank-Sum tests for continuous variables and Pearson chi-square test for categorical variables. Standard mixed modelling practices will be employed to test for changes in biomarkers of lung injury following transfusion. Linear regression will assess relationships between randomised group and post-transfusion physiologic measures. Safety oversight will be conducted under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained by the DSMB as well as the institutional review boards at each institution prior to enrolling the first study participant. This study aims to provide important information regarding the feasibility of POC washing of allogeneic RBCs and its potential impact on ameliorating post-transfusion respiratory complications. Additionally, it will inform the feasibility and scientific merit of pursuing a more definitive phase II/III clinical trial. ClinicalTrials.gov registration number is NCT02094118 (Pre-results). © 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.

Tools to reduce first year nursing students' anxiety levels prior to undergoing objective structured clinical assessment (OSCA) and how this impacts on the student's experience of their first clinical placement.

PubMed

Stunden, Annette; Halcomb, Elizabeth; Jefferies, Diana

2015-09-01

One form of assessment that tests students' theoretical skills and confidence in their clinical practice is known as the Objective Structured Clinical Assessment (OSCA). Traditionally it was first launched from medical education, and is now being incorporated by other disciplines, such as nursing. This review seeks to present the best available evidence into strategies that help reduce first year nursing students' anxiety levels prior to undergoing OSCA and clinical placement. A systematic literature search was performed using Medline and CINAHL. This review considered any English language original research published between 2005 and 2013. A literature search located 117 articles. Eight articles were identified as meeting the inclusion in criteria. Majority of studies reported simulation session prior to the OSCA increased students confidence and reduced their anxiety levels. This resulted in students' reporting that they valued the OSCA as a worthwhile assessment. However there were four major themes: that students were anxious about attending the OSCA; that adequate preparation was seen as a coping strategy; that simulation was a further cause for anxiety; and that the simulation experience could also be used as an OSCA tool. Students who have been exposed to simulation scenarios before the OSCA are able to cope much better during the OSCA. Therefore, it is highly recommended to incorporate simulation scenarios into the nursing curricula for first year nursing students' clinical units to help reduce their anxiety levels prior to OCSA. Copyright © 2015 Elsevier Ltd. All rights reserved.

Neuropsychological functioning in preschool-aged children undergoing evaluation for organ transplant.

PubMed

Antonini, Tanya N; Beer, Stacey S; Miloh, Tamir; Dreyer, William J; Caudle, Susan E

2017-02-01

The purpose of this study was to review the current literature on neuropsychological functioning in two groups of children requiring organ transplants (liver or heart) and present recent clinical data collected through the liver and cardiac transplantation programs at a large pediatric academic medical center. Data included in this study came from 18 patients who completed evaluations for heart transplant (n = 8) or liver transplant (n = 10) between the ages of 2 and 6 years (inclusive). Measures examining neurocognitive, emotional-behavioral, and adaptive functioning were collected as part of standard pre-transplant clinical neuropsychological evaluations. Within each organ group, mean scores were calculated and compared with normative population mean scores using one sample t-tests. In addition, non-parametric binomial tests were calculated to examine whether the proportion of individuals falling more than one standard deviation below the population mean was significantly greater in the patient groups than the normative population base rate of 16%. Patients in both groups performed below normative expectation in several neurocognitive and adaptive domains. However, neither group showed significant difficulties in behavioral or emotional regulation. Results from this study document cognitive delays in preschool-aged children undergoing evaluations for liver transplant or heart transplant, highlighting the importance of intervention and long-term monitoring of these two patient populations, as well as the need for neuropsychologist involvement with transplant teams.

Validity, reliability and responsiveness of the EQ-5D in German stroke patients undergoing rehabilitation.

PubMed

Hunger, Matthias; Sabariego, Carla; Stollenwerk, Björn; Cieza, Alarcos; Leidl, Reiner

2012-09-01

To analyse the psychometric properties of the EQ-5D in German stroke survivors undergoing neurological rehabilitation. The EQ-5D, the Hospital Anxiety and Depression Scale (HADS) and the Stroke Impact Scale (SIS) were completed before (210 subjects) and after (183 subjects) a patient education programme in seven rehabilitation clinics in Bavaria, Germany. A postal follow-up was conducted after 6 months. Acceptance, validity, reliability and responsiveness of the EQ-5D were tested. The SIS subscales were used as external anchors to classify the patients into change groups between the measurements. The proportion of missing answers ranged from 4.7 to 8.6%. Between 16 and 19% reported no problems in any EQ-5D dimension. At baseline, correlations between EQ-5D index and the SIS subscales ranged from 0.15 (communication) to 0.60 (mobility). Correlations with the EQ VAS were slightly smaller. All scores were reliable in test-retest with intraclass correlations ranging from 0.67 to 0.81. EQ-5D index and EQ VAS were consistently responsive only to improvements in health, showing small- to medium effect sizes (0.27-0.42). The EQ-5D has shown reasonable validity, reliability and, more limited, responsiveness in stroke patients with mild to moderate limitations of functional status, allowing it to be used in clinical trials in rehabilitation.

Optical assessment of tumor resection margins in the breast

PubMed Central

Brown, J. Quincy; Bydlon, Torre M.; Richards, Lisa M.; Yu, Bing; Kennedy, Stephanie A.; Geradts, Joseph; Wilke, Lee G.; Junker, Marlee; Gallagher, Jennifer; Barry, William; Ramanujam, Nimmi

2011-01-01

Breast conserving surgery, in which the breast tumor and surrounding normal tissue are removed, is the primary mode of treatment for invasive and in situ carcinomas of the breast, conditions that affect nearly 200,000 women annually. Of these nearly 200,000 patients who undergo this surgical procedure, between 20–70% of them may undergo additional surgeries to remove tumor that was left behind in the first surgery, due to the lack of intra-operative tools which can detect whether the boundaries of the excised specimens are free from residual cancer. Optical techniques have many attractive attributes which may make them useful tools for intra-operative assessment of breast tumor resection margins. In this manuscript, we discuss clinical design criteria for intra-operative breast tumor margin assessment, and review optical techniques appied to this problem. In addition, we report on the development and clinical testing of quantitative diffuse reflectance imaging (Q-DRI) as a potential solution to this clinical need. Q-DRI is a spectral imaging tool which has been applied to 56 resection margins in 48 patients at Duke University Medical Center. Clear sources of contrast between cancerous and cancer-free resection margins were identified with the device, and resulted in an overall accuracy of 75% in detecting positive margins. PMID:21544237

Diagnosis of hepatitis C virus infection in pregnant women in the healthcare system in Poland: Is it worth the effort?

PubMed

Walewska-Zielecka, Bożena; Religioni, Urszula; Juszczyk, Grzegorz; Czerw, Aleksandra; Wawrzyniak, Zbigniew; Soszyński, Piotr

2016-07-01

The hepatitis C virus (HCV) is globally recognized as a serious public health concern. Current statistics indicate that approximately 2% of people worldwide and 1.9% of people in Poland suffer from HCV infection.This study was conducted to assess the anti-HCV seroprevalence in pregnant women in Poland and subsequently provide recommendations on the rationale for obligatory screening.A total of 42,274 women participated in our study, of which 16,130 were pregnant. We were granted access to their health data stored in the form of electronic medical records kept by the network of outpatient clinics throughout Poland.The lowest rate of positive anti-HCV test results was found in women ages 25 to 34 (0.73%); however, younger and older age groups had similar rates (15-24 = 0.86%; 35-44 = 0.84%). Additional analysis of data from the period between 2011 and 2014 revealed a downward trend in the proportion of positive anti-HCV tests among pregnant women (mean positive anti-HCV = -0.001 × year + 1.9451; R = 0.7274). Regardless of the gradual increase in the number of female patients undergoing screening between 2004 and 2015, there has been a constant decrease in the rate of positive cases. The rate of pregnant women potentially infected with HCV was twice as lower than that in a control group of women undergoing tests for other medical circumstances: 0.76% vs 1.67% (P < 0.0001).Analysis of real-world data of female patients in Poland provides evidence that screening based on an individual's medical history and behavioral risk factors in clinical circumstances would be more effective than obligatory testing of all pregnant women.

Wavefront-Guided Versus Wavefront-Optimized Photorefractive Keratectomy: Visual and Military Task Performance.

PubMed

Ryan, Denise S; Sia, Rose K; Stutzman, Richard D; Pasternak, Joseph F; Howard, Robin S; Howell, Christopher L; Maurer, Tana; Torres, Mark F; Bower, Kraig S

2017-01-01

To compare visual performance, marksmanship performance, and threshold target identification following wavefront-guided (WFG) versus wavefront-optimized (WFO) photorefractive keratectomy (PRK). In this prospective, randomized clinical trial, active duty U.S. military Soldiers, age 21 or over, electing to undergo PRK were randomized to undergo WFG (n = 27) or WFO (n = 27) PRK for myopia or myopic astigmatism. Binocular visual performance was assessed preoperatively and 1, 3, and 6 months postoperatively: Super Vision Test high contrast, Super Vision Test contrast sensitivity (CS), and 25% contrast acuity with night vision goggle filter. CS function was generated testing at five spatial frequencies. Marksmanship performance in low light conditions was evaluated in a firing tunnel. Target detection and identification performance was tested for probability of identification of varying target sets and probability of detection of humans in cluttered environments. Visual performance, CS function, marksmanship, and threshold target identification demonstrated no statistically significant differences over time between the two treatments. Exploratory regression analysis of firing range tasks at 6 months showed no significant differences or correlations between procedures. Regression analysis of vehicle and handheld probability of identification showed a significant association with pretreatment performance. Both WFG and WFO PRK results translate to excellent and comparable visual and military performance. Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.

Influence of patient-related and surgery-related risk factors on cognitive performance, emotional state, and convalescence after cardiac surgery.

PubMed

Ille, Rottraut; Lahousen, Theresa; Schweiger, Stefan; Hofmann, Peter; Kapfhammer, Hans-Peter

2007-01-01

Cardiac surgery may account for complications such as cognitive impairment, depression, and delay of convalescence. This study investigated the influence of different risk factors on cognitive performance, emotional state, and convalescence. We included 83 patients undergoing cardiac surgery who had no indication of postoperative delirium. Psychometric testing was performed 1 day before and 7 days after surgery. Neuron-specific enolase (NSE) levels were measured 1 day before and 36 h after surgery. Depression score increased after surgery, but patients showed no clinically significant depression. Postoperative cognitive performance correlated with postoperative depression level and preoperative cognitive performance. Forty-three percent of patients showed postoperative decline. Older patients exhibited a higher postoperative increase in NSE concentrations. Patients undergoing coronary artery bypass grafts or combined procedures exhibited more medical risk factors than those undergoing valve surgery alone. The number of bypass grafts was associated with time of hospitalization, and the number of patient-related risk factors correlated with stay in intensive care unit. For elderly patients undergoing cardiac surgery, older age, total preexisting medical risk factors, and surgery duration seem to be the most important factors influencing cognitive outcome and convalescence. Results show that, also for patients without postoperative delirium, medical risk factors and intraoperative parameters can result in delay of convalescence.

Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial.

PubMed

Schwartz, Peter H; Perkins, Susan M; Schmidt, Karen K; Muriello, Paul F; Althouse, Sandra; Rawl, Susan M

2017-08-01

Guidelines recommend that patient decision aids should provide quantitative information about probabilities of potential outcomes, but the impact of this information is unknown. Behavioral economics suggests that patients confused by quantitative information could benefit from a "nudge" towards one option. We conducted a pilot randomized trial to estimate the effect sizes of presenting quantitative information and a nudge. Primary care patients (n = 213) eligible for colorectal cancer screening viewed basic screening information and were randomized to view (a) quantitative information (quantitative module), (b) a nudge towards stool testing with the fecal immunochemical test (FIT) (nudge module), (c) neither a nor b, or (d) both a and b. Outcome measures were perceived colorectal cancer risk, screening intent, preferred test, and decision conflict, measured before and after viewing the decision aid, and screening behavior at 6 months. Patients viewing the quantitative module were more likely to be screened than those who did not ( P = 0.012). Patients viewing the nudge module had a greater increase in perceived colorectal cancer risk than those who did not ( P = 0.041). Those viewing the quantitative module had a smaller increase in perceived risk than those who did not ( P = 0.046), and the effect was moderated by numeracy. Among patients with high numeracy who did not view the nudge module, those who viewed the quantitative module had a greater increase in intent to undergo FIT ( P = 0.028) than did those who did not. The limitations of this study were the limited sample size and single healthcare system. Adding quantitative information to a decision aid increased uptake of colorectal cancer screening, while adding a nudge to undergo FIT did not increase uptake. Further research on quantitative information in decision aids is warranted.

A Randomized-Controlled Trial Examining the Effects of Reflexology on Anxiety of Patients Undergoing Coronary Angiography

PubMed Central

Molavi Vardanjani, Mehdi; Masoudi Alavi, Negin; Razavi, Narges Sadat; Aghajani, Mohammad; Azizi-Fini, Esmail; Vaghefi, Seied Morteza

2013-01-01

Background: The anxiety reduction before coronary angiography has clinical advantages and is one of the objectives of nursing. Reflexology is a non-invasive method that has been used in several clinical situations. Applying reflexology might have effect on the reduction of anxiety before coronary angiography. Objectives: The aim of this randomized clinical trial was to investigate the effect of reflexology on anxiety among patients undergoing coronary angiography. Patients and Methods: This trial was conducted in Shahid Beheshti Hospital, in Kashan, Iran. One hundred male patients who were undergoing coronary angiography were randomly enrolled into intervention and placebo groups. The intervention protocol was included 30 minutes of general foot massage and the stimulation of three reflex points including solar plexus, pituitary gland, and heart. The placebo group only received the general foot massage. Spielbergers state trait anxiety inventory was used to assess the anxiety experienced by patients. Data was analyzed using Man-Witney, Wilcoxon and Chi-square tests. The stepwise multiple regressions used to analyze the variables that are involved in anxiety reduction. Results: The mean range of anxiety decreased from 53.24 to 45.24 in reflexology group which represented 8 score reduction (P = 0.0001). The reduction in anxiety was 5.9 score in placebo group which was also significant (P = 0.0001). The anxiety reduction was significantly higher in reflexology group (P = 0.014). The stepwise multiple regression analysis showed that doing reflexology can explain the 7.5% of anxiety reduction which made a significant model. Conclusions: Reflexology can decrease the anxiety level before coronary angiography. Therefore, reflexology before coronary angiography is recommended. PMID:25414869

Differential effects of aprotinin and tranexamic acid on outcomes and cytokine profiles in neonates undergoing cardiac surgery.

PubMed

Graham, Eric M; Atz, Andrew M; Gillis, Jenna; Desantis, Stacia M; Haney, A Lauren; Deardorff, Rachael L; Uber, Walter E; Reeves, Scott T; McGowan, Francis X; Bradley, Scott M; Spinale, Francis G

2012-05-01

Factors contributing to postoperative complications include blood loss and a heightened inflammatory response. The objective of this study was to test the hypothesis that aprotinin would decrease perioperative blood product use, reduce biomarkers of inflammation, and result in improved clinical outcome parameters in neonates undergoing cardiac operations. This was a secondary retrospective analysis of a clinical trial whereby neonates undergoing cardiac surgery received either aprotinin (n = 34; before May 2008) or tranexamic acid (n = 42; after May 2008). Perioperative blood product use, clinical course, and measurements of cytokines were compared. Use of perioperative red blood cells, cryoprecipitate, and platelets was reduced in neonates receiving aprotinin compared with tranexamic acid (P < .05). Recombinant activated factor VII use (2/34 [6%] vs 18/42 [43%]; P < .001), delayed sternal closure (12/34 [35%] vs 26/42 [62%]; P = .02), and inotropic requirements at 24 and 36 hours (P < .05) were also reduced in the aprotinin group. Median duration of mechanical ventilation was reduced compared with tranexamic acid: 2.9 days (interquartile range: 1.7-5.1 days) versus 4.2 days (2.9-5.2 days), P = .04. Production of tumor necrosis factor and interleukin-2 activation were attenuated in the aprotinin group at 24 hours postoperatively. No differential effects on renal function were seen between agents. Aprotinin, compared with tranexamic acid, was associated with reduced perioperative blood product use, improved early indices of postoperative recovery, and attenuated indices of cytokine activation, without early adverse effects. These findings suggest that aprotinin may have unique effects in the context of neonatal cardiac surgery and challenge contentions that antifibrinolytics are equivalent with respect to early postoperative outcomes. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Differential effects of aprotinin and tranexamic acid on outcomes and cytokine profiles in neonates undergoing cardiac surgery

PubMed Central

Graham, Eric M.; Atz, Andrew M.; Gillis, Jenna; DeSantis, Stacia M.; Haney, A. Lauren; Deardorff, Rachael L.; Uber, Walter E.; Reeves, Scott T.; McGowan, Francis X.; Bradley, Scott M.; Spinale, Francis G.

2011-01-01

Objective Factors contributing to postoperative complications include blood loss and a heightened inflammatory response. The objective of this study was to test the hypothesis that aprotinin would decrease perioperative blood product use, reduce biomarkers of inflammation, and result in improved clinical outcome parameters in neonates undergoing cardiac operations. Methods This was a secondary retrospective analysis of a clinical trial whereby neonates undergoing cardiac surgery received either aprotinin (n = 34; before May 2008) or tranexamic acid (n = 42; after May 2008). Perioperative blood product use, clinical course, and measurements of cytokines were compared. Results Use of perioperative red blood cells, cryoprecipitate, and platelets was reduced in neonates receiving aprotinin compared with tranexamic acid (P < .05). Recombinant activated factor VII use (2/34 [6%] vs 18/42 [43%]; P < .001), delayed sternal closure (12/34 [35%] vs 26/42 [62%]; P = .02), and inotropic requirements at 24 and 36 hours (P < .05) were also reduced in the aprotinin group. Median duration of mechanical ventilation was reduced compared with tranexamic acid: 2.9 days (interquartile range: 1.7–5.1 days) versus 4.2 days (2.9–5.2days), P = .04. Production of tumor necrosis factor and interleukin-2 activation were attenuated in the aprotinin group at 24 hours postoperatively. No differential effects on renal function were seen between agents. Conclusions Aprotinin, compared with tranexamic acid, was associated with reduced perioperative blood product use, improved early indices of postoperative recovery, and attenuated indices of cytokine activation, without early adverse effects. These findings suggest that aprotinin may have unique effects in the context of neonatal cardiac surgery and challenge contentions that antifibrinolytics are equivalent with respect to early postoperative outcomes. PMID:22075061

Construction of a Clinical Decision Support System for Undergoing Surgery Based on Domain Ontology and Rules Reasoning

PubMed Central

Bau, Cho-Tsan; Huang, Chung-Yi

2014-01-01

Abstract Objective: To construct a clinical decision support system (CDSS) for undergoing surgery based on domain ontology and rules reasoning in the setting of hospitalized diabetic patients. Materials and Methods: The ontology was created with a modified ontology development method, including specification and conceptualization, formalization, implementation, and evaluation and maintenance. The Protégé–Web Ontology Language editor was used to implement the ontology. Embedded clinical knowledge was elicited to complement the domain ontology with formal concept analysis. The decision rules were translated into JENA format, which JENA can use to infer recommendations based on patient clinical situations. Results: The ontology includes 31 classes and 13 properties, plus 38 JENA rules that were built to generate recommendations. The evaluation studies confirmed the correctness of the ontology, acceptance of recommendations, satisfaction with the system, and usefulness of the ontology for glycemic management of diabetic patients undergoing surgery, especially for domain experts. Conclusions: The contribution of this research is to set up an evidence-based hybrid ontology and an evaluation method for CDSS. The system can help clinicians to achieve inpatient glycemic control in diabetic patients undergoing surgery while avoiding hypoglycemia. PMID:24730353

Construction of a clinical decision support system for undergoing surgery based on domain ontology and rules reasoning.

PubMed

Bau, Cho-Tsan; Chen, Rung-Ching; Huang, Chung-Yi

2014-05-01

To construct a clinical decision support system (CDSS) for undergoing surgery based on domain ontology and rules reasoning in the setting of hospitalized diabetic patients. The ontology was created with a modified ontology development method, including specification and conceptualization, formalization, implementation, and evaluation and maintenance. The Protégé-Web Ontology Language editor was used to implement the ontology. Embedded clinical knowledge was elicited to complement the domain ontology with formal concept analysis. The decision rules were translated into JENA format, which JENA can use to infer recommendations based on patient clinical situations. The ontology includes 31 classes and 13 properties, plus 38 JENA rules that were built to generate recommendations. The evaluation studies confirmed the correctness of the ontology, acceptance of recommendations, satisfaction with the system, and usefulness of the ontology for glycemic management of diabetic patients undergoing surgery, especially for domain experts. The contribution of this research is to set up an evidence-based hybrid ontology and an evaluation method for CDSS. The system can help clinicians to achieve inpatient glycemic control in diabetic patients undergoing surgery while avoiding hypoglycemia.

Profound hearing loss associated with hydrocodone/acetaminophen abuse.

PubMed

Friedman, R A; House, J W; Luxford, W M; Gherini, S; Mills, D

2000-03-01

To describe profound hearing loss associated with hydrocodone overuse and the successful rehabilitation of these patients with cochlear implantation. Retrospective review. A tertiary otologic referral center. Twelve patients with rapidly progressive hearing loss and a concurrent history of hydrocodone overuse. Comprehensive medical histories, physical findings, audiometric tests, and, in those patients undergoing cochlear implantation, postimplantation performance data were reviewed. Clinical characteristics of hydrocodone-related hearing loss and open set word and sentence performance in those patients undergoing cochlear implantation. Hydrocodone overuse was associated with rapidly progressive sensorineural hearing loss in 12 patients. In four patients the initial presentation was unilateral, and two of the patients experienced vestibular symptoms. None of the 12 patients experienced improved thresholds after high-dose prednisone. Seven of the eight patients undergoing cochlear implantation have demonstrated early success with their devices. Hydrocodone is frequently prescribed in combination with acetaminophen for the relief of pain and has a side effects profile similar to other medications in its class. Although not described previously, overuse or abuse can be associated with a rapidly progressive sensorineural hearing loss. These patients can be successfully rehabilitated with cochlear implantation.

Clinical outcomes and frontal plane two-dimensional biomechanics during the 30-second single leg stance test in patients before and after hip abductor tendon reconstructive surgery.

PubMed

Huxtable, Rose E; Ackland, Timothy R; Janes, Gregory C; Ebert, Jay R

2017-07-01

Hip abductor tendon tears are a common cause of Greater Trochanteric Pain Syndrome. Conservative treatments are often ineffective and surgical reconstruction may be recommended. This study investigated the improvement in clinical outcomes and frontal plane two-dimensional biomechanics during a 30-second single leg stance test, in patients undergoing reconstruction. We hypothesized that clinical scores and pertinent biomechanical variables would significantly improve post-surgery, and these outcomes would be significantly correlated. Twenty-one patients with symptomatic tendon tears underwent reconstruction. Patients were evaluated pre-surgery, and at 6 and 12months post-surgery, using patient-reported outcome measures, assessment of hip abductor strength and six-minute walk capacity. Frontal plane, two-dimensional, biomechanical variables including pelvis-on-femur angle, pelvic drop, trunk lean and lateral pelvic shift, were evaluated throughout a 30-second single leg stance test. ANOVA evaluated outcomes over time, while Pearson's correlations investigated associations between clinical scores, pain, functional and biomechanical outcome variables. While clinical and functional measures significantly improved (P<0.05) over time, no significant group differences (P>0.05) were observed in biomechanical variables from pre- to post-surgery. While five patients displayed a positive Trendelenburg sign pre-surgery, only one was positive post-surgery. Clinical outcomes and biomechanical variables during the single leg stance test were not correlated. Despite improvements in clinical and functional measures over time, biomechanical changes during a weight bearing single leg stance test were not significantly different following tendon repair. Follow up beyond 12months may be required, whereby symptomatic relief may precede functional and biomechanical improvement. Copyright © 2017 Elsevier Ltd. All rights reserved.

Criteria for the request of preoperative tests among oral and maxillofacial surgeons.

PubMed

da Silva, Luiz Carlos Ferreira; Oliveira, Ana Carla de Assunção; dos Santos, Jadson Alípio Santana Sousa; Santos, Thiago de Santana

2012-10-01

The aim of this study was to analyze the criteria employed for the requesting of preoperative tests among maxillofacial surgeons. Thirty maxillofacial surgeons working in Aracaju (Brazil) received a questionnaire to fill out. The study inquired about the practice of requesting preoperative tests for healthy patients scheduled to undergo elective surgery. Most of the surgeons interviewed requested tests that are not recommended for the case in question. The highest frequency of requests was a complete blood count, coagulation test, blood glucose test and chest radiograph. The absence of strict rules for the requesting of preoperative tests causes uncertainty and a lack of criteria regarding pre-surgical conduct. It was not possible to clearly define the criteria used by surgeons for requesting such tests, as the clinical characteristics of the hypothetical case presented suggest a smaller number of tests. Copyright © 2011 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Transversus Abdominis Plane Block versus Ilioinguinal/Iliohypogastric Nerve Block with Wound Infiltration for Postoperative Analgesia in Inguinal Hernia Surgery: A Randomized Clinical Trial.

PubMed

Sujatha, Chinthavali; Zachariah, Mamie; Ranjan, R V; George, Sagiev Koshy; Ramachandran, T R; Pillai, Anil Radhakrishna

2017-01-01

Various analgesic modalities have been used for postoperative analgesia in patients undergoing inguinal hernia surgery. In this randomized clinical trial, we have compared the analgesic efficacy of transversus abdominis plane (TAP) block with that of ilioinguinal/iliohypogastric (IIIH) nerve block with wound infiltration in patients undergoing unilateral open inguinal hernia repair. The primary objective of this study was to compare the efficacy of postoperative analgesia of ultrasound-guided TAP block and IIIH block with wound infiltration (WI) in patients undergoing open inguinal hernia surgery. This was a randomized clinical trial performed in a tertiary care hospital. Sixty patients scheduled for hernia repair were randomized into two groups, Group T and Group I. Postoperatively, under ultrasound guidance, Group T received 20 ml of 0.25% ropivacaine - TAP block and Group I received 10 ml of 0.25% ropivacaine - IIIH block + WI with 10 ml of 0.25% ropivacaine. The primary outcome measure was the time to rescue analgesia in the first 24 h postoperatively. Fentanyl along with diclofenac was given as first rescue analgesic when the patient complained of pain. Statistical comparisons were performed using Student's t -test and Chi-square test. Mean time to rescue analgesia was 5.900 ± 1.881 h and 3.766 ± 1.754 h ( P < 0.001) and the mean pain scores were 5.73 ± 0.784 and 6.03 ± 0.850 for Group TAP and IIIH + WI, respectively. Hemodynamics were stable in both the groups. One-third of the patients received one dose of paracetamol in addition to the rescue analgesic in the first 24 h. There were no complications attributed to the block. As a multimodal analgesic regimen, definitely both TAP block and IIIH block with wound infiltration have a supporting role in providing analgesia in the postoperative period for adult inguinal hernia repair. In this study, ultrasound-guided TAP block provided longer pain control postoperatively than IIIH block with WI after inguinal hernia repair. There were no complications attributed to the blocks in either of the group.

[Pulmonary hypertensive crisis in children with idiopathic pulmonary arterial hypertension undergoing cardiac catheterization: the risk factors and clinical aspects].

PubMed

Zhang, C; Zhu, Y; Li, Q Q; Gu, H

2018-06-02

Objective: To investigate the risk factors, clinical features, treatments, and prevention of pulmonary hypertensive crisis (PHC) in children with idiopathic pulmonary arterial hypertension (IPAH) undergoing cardiac catheterization. Methods: This retrospective study included 67 children who were diagnosed with IPAH and underwent cardiac catheterization between April 2009 and June 2017 in Beijing Anzhen Hospital. The medical histories, clinical manifestations, treatments, and outcomes were characterized. Statistical analyses were performed using t test, χ(2) test and a multiple Logistic regression analysis. Results: During cardiac catheterization, five children developed PHC who presented with markedly elevated pulmonary artery pressure and central venous pressure, decline in systemic arterial pressure and oxygen saturation. Heart rate decreased in 4 cases and increased in the remaining one. After the treatments including cardiopulmonary resuscitation, pulmonary vasodilator therapy, improving cardiac output and blood pressure, and correction of acidosis, 4 of the 5 cases recovered, while 1 died of severe right heart failure with irreversible PHC 3 days after operation. Potential PHC was considered in 7 other patients, whose pulmonary artery pressure increased and exceeded systemic arterial pressure, oxygen saturation decreased, and central venous pressure and vital signs were relatively stable. Univariate analysis showed that the risk factors of PHC in children with IPAH undergoing cardiac catheterization were younger age ( t= 3.160, P= 0.004), low weight ( t= 4.004, P< 0.001), general anesthesia (χ(2)=4.970, P= 0.026), history of syncope (χ(2)=4.948, P= 0.026), and WHO cardiac functional class Ⅲ or Ⅳ (χ(2)=19.013, P< 0.001). Multivariate Logistic regression analysis revealed that worse WHO cardiac functional class ( Wald =13.128, P< 0.001, OR= 15.076, 95% CI : 3.475-65.418) was the independent risk factor of PHC. Conclusions: PHC is a severe and extremely dangerous complication in children with IPAH during cardiac catheterization. WHO cardiac functional class may be associated with PHC. Integrated treatment is required for these patients. Reducing risk factors, early identification, and active treatment may help to prevent the occurrence and progression of PHC.

Sperm retrieval rate and pregnancy rate in infertile couples undergoing in-vitro fertilisation and testicular sperm extraction for non-obstructive azoospermia in Hong Kong.

PubMed

Ko, J Ky; Chai, J; Lee, V Cy; Li, R Hw; Lau, E; Ho, K L; Tam, P C; Yeung, W Sb; Ho, P C; Ng, E Hy

2016-12-01

There are currently no local data on the sperm retrieval and pregnancy rates in in-vitro fertilisation and testicular sperm extraction cycles, especially with regard to the presence of genetic abnormalities. This study aimed to determine the sperm retrieval and pregnancy rates in infertile couples who underwent in-vitro fertilisation and testicular sperm extraction for non-obstructive azoospermia. This retrospective case series was conducted at a tertiary assisted reproduction unit in Hong Kong. Men with non-obstructive azoospermia who underwent in-vitro fertilisation and testicular sperm extraction between January 2001 and December 2013 were included. The main outcome measures were sperm retrieval and pregnancy rates. During the study period, 89 men with non-obstructive azoospermia underwent in-vitro fertilisation and testicular sperm extraction. Sperm was successfully retrieved in 40 (44.9%) men. There was no statistically significant difference in the sperm retrieval rate of those with karyotypic abnormalities (2/5, 40.0% vs 28/61, 45.9%; P=1.000) and AZFc microdeletion (3/6, 50.0% vs 28/61, 45.9%; P=1.000) compared with those without. Sperms were successfully retrieved in patients who had mosaic Klinefelter syndrome (2/3, 66.7%) but not in the patient with non-mosaic Klinefelter syndrome. No sperms were found in men with AZFa or AZFb microdeletions. Pregnancy test was positive in 15 (16.9%) patients and the clinical pregnancy rate was 13.5% (12/89) per cycle. The clinical pregnancy rate per transfer was 34.3% (12/35). The sperm retrieval rate and clinical pregnancy rate per initiated cycle in men undergoing in-vitro fertilisation and testicular sperm extraction in our unit were 44.9% and 13.5%, respectively. No sperms could be retrieved in the presence of AZFa and AZFb microdeletions, but karyotype and AZFc microdeletion abnormalities otherwise did not predict the success of sperm retrieval in couples undergoing in-vitro fertilisation and testicular sperm extraction. Genetic tests are important prior to testicular sperm extraction for patient selection and genetic counselling.

[The value of SYNTAX score in predicting outcome patients undergoing percutaneous coronary intervention].

PubMed

Gao, Yue-chun; Yu, Xian-peng; He, Ji-qiang; Chen, Fang

2012-01-01

To assess the value of SYNTAX score to predict major adverse cardiac and cerebrovascular events (MACCE) among patients with three-vessel or left-main coronary artery disease undergoing percutaneous coronary intervention. 190 patients with three-vessel or left-main coronary artery disease undergoing percutaneous coronary intervention (PCI) with Cypher select drug-eluting stent were enrolled. SYNTAX score and clinical SYNTAX score were retrospectively calculated. Our clinical Endpoint focused on MACCE, a composite of death, nonfatal myocardial infarction (MI), stroke and repeat revascularization. The value of SYNTAX score and clinical SYNTAX score to predict MACCE were studied respectively. 29 patients were observed to suffer from MACCE, accounting 18.5% of the overall 190 patients. MACCE rates of low (≤ 20.5), intermediate (21.0 - 31.0), and high (≥ 31.5) tertiles according to SYNTAX score were 9.1%, 16.2% and 30.9% respectively. Both univariate and multivariate analysis showed that SYNTAX score was the independent predictor of MACCE. MACCE rates of low (≤ 19.5), intermediate (19.6 - 29.1), and high (≥ 29.2) tertiles according to clinical SYNTAX score were 14.9%, 9.8% and 30.6% respectively. Both univariate and multivariate analysis showed that clinical SYNTAX score was the independent predictor of MACCE. ROC analysis showed both SYNTAX score (AUC = 0.667, P = 0.004) and clinical SYNTAX score (AUC = 0.636, P = 0.020) had predictive value of MACCE. Clinical SYNTAX score failed to show better predictive ability than the SYNTAX score. Both SYNTAX score and clinical SYNTAX score could be independent risk predictors for MACCE among patients with three-vessel or left-main coronary artery disease undergoing percutaneous coronary intervention. Clinical SYNTAX score failed to show better predictive ability than the SYNTAX score in this group of patients.

Increased alloimmunisation and transfusion reaction reporting in patients with solid-phase panreactivity.

PubMed

Olofson, Andrea M; Chandler, Rachael M; Marx-Wood, Cynthia R; Babcock, Craig A; Dunbar, Nancy M

2017-11-01

Automated solid-phase antibody screening uses red blood cell (RBC) membranes immobilised on polystyrene test wells to detect RBC specific antibodies. Despite its time-saving and labour-saving benefits, this method produces a higher rate of nonspecific reactivity compared with manual screening. Solid-phase panreactivity (SPP) is characterised by panreactivity (ie, all test cells reacting) in solid-phase testing accompanied by a negative autocontrol and a lack of reactivity when the same screening cells are tested in tube. The mechanisms underlying SPP and its clinical significance remain unclear. The goals of this study were to describe the prevalence of SPP at our institution and determine the alloimmunisation and transfusion reaction rates within this population. Data were collected on all patients undergoing type and screen testing over a 6-year period. Study patients undergoing subsequent transfusion were evaluated for reported transfusion reactions and development of new alloantibodies. Of the 76 051 patients studied, 0.7% demonstrated SPP of which 11% developed new alloantibodies. The transfusion reaction reporting rate among patients with SPP was 2%. Our data suggest that patients with SPP have higher rates of reported transfusion reactions and alloantibody development compared with those without SPP. 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/.

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.

The ideal laboratory information system.

PubMed

Sepulveda, Jorge L; Young, Donald S

2013-08-01

Laboratory information systems (LIS) are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests. In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care. Specific suggestions for improving the function of LIS are listed under the following sections: (1) Information Security, (2) Test Ordering, (3) Specimen Collection, Accessioning, and Processing, (4) Analytic Phase, (5) Result Entry and Validation, (6) Result Reporting, (7) Notification Management, (8) Data Mining and Cross-sectional Reports, (9) Method Validation, (10) Quality Management, (11) Administrative and Financial Issues, and (12) Other Operational Issues.

Is Personalized Medicine Achievable in Obstetrics?

PubMed Central

Quinney, Sara K; Flockhart, David A; Patil, Avinash S

2014-01-01

Personalized medicine seeks to identify the right dose of the right drug for the right patient at the right time. Typically, individualization of therapy is based on the pharmacogenomic make-up of the individual and environmental factors that alter drug disposition and response. In addition to these factors, during pregnancy a woman’s body undergoes many changes that can impact the therapeutic efficacy of medications. Yet, there is minimal research regarding personalized medicine in obstetrics. Adoption of pharmacogenetic testing into the obstetrical care is dependent on evidence of analytical validity, clinical validity, and clinical utility. Here, we briefly present information regarding the potential utility of personalized medicine for treating the obstetric patient for pain with narcotics, hypertension, and preterm labor and discuss the impediments of bringing personalized medicine to the obstetrical clinic. PMID:25282474

How concerns for bisphosphonate-induced osteonecrosis of the jaw affect clinical practice among dentists: a study from the South Texas Oral Health Network

PubMed Central

Gonzales, Cara B.; Young, Veronica; Ketchum, Norma S.; Bone, Jamie; Oates, Thomas W.; Mungia, Rahma

2015-01-01

Bisphosphonate-induced osteonecrosis of the jaw (BONJ) represents a growing concern for dentists and patients, in that it may alter clinical care. This study assesses the knowledge and perceptions of practicing dentists in relation to the risk of BONJ and how their knowledge and perceptions influence their decisions when developing treatment plans. For this study, a sample of dentists (n = 93) in South Texas completed a 38-item survey about BONJ knowledge and perception and their current clinical practices for patients undergoing bisphosphonate therapy. Knowledge score groupings reflected differences between low-knowledge and high-knowledge dentists in terms of their behavior concerning medical history, alternative treatments offered, and routine blood testing for patients on bisphosphonate therapy. PMID:25734289

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.

Outcomes of complete vs targeted approaches to endoscopic sinus surgery.

PubMed

DeConde, Adam S; Suh, Jeffrey D; Mace, Jess C; Alt, Jeremiah A; Smith, Timothy L

2015-08-01

Functional endoscopic sinus surgery (FESS) was historically predicated on targeted widening of narrow anatomic structures that caused postobstructive persistent sinus inflammation. It is now clear that chronic rhinosinusitis (CRS) is a multifactorial disease with subsets of patients which may require a more extensive surgical approach. This study compares quality-of-life (QOL) and disease severity outcomes after FESS based on the extent of surgical intervention. Participants with CRS were prospectively enrolled into an ongoing, multi-institutional, observational, cohort study. Surgical extent was determined by physician discretion. Participants undergoing bilateral frontal sinusotomy, ethmoidectomy, maxillary antrostomy, and sphenoidotomy were considered to have undergone "complete" surgery, whereas all other participants were categorized as receiving "targeted" surgery. Improvement was evaluated between surgical subgroups with at least 6-month follow-up using the 22-item Sino-Nasal Outcome Test (SNOT-22) and the Brief Smell Inventory Test (B-SIT). A total of 311 participants met inclusion criteria with 147 subjects undergoing complete surgery and 164 targeted surgery. A higher prevalence of asthma, acetylsalicylic acid (ASA) sensitivity, nasal polyposis, and a history of prior sinus surgery (p ≤ 0.002) was present in participants undergoing complete surgery. Mean improvement in SNOT-22 (28.1 ± 21.9 vs 21.9 ± 20.6; p = 0.011) and B-SIT (0.8 ± 3.1 vs 0.2 ± 2.4; p = 0.005) was greater in subjects undergoing complete surgery. Regression models demonstrated a 5.9 ± 2.5 greater relative mean improvement on SNOT-22 total scores with complete surgery over targeted approaches (p = 0.016). Complete surgery was an independent predictor of greater postoperative SNOT-22 score improvement, yet did not achieve clinical significance. Further study is needed to determine the optimal surgical extent. © 2015 ARS-AAOA, LLC.

Modern Advances in Genetic Testing: Ethical Challenges and Training Implications for Current and Future Psychologists

PubMed Central

Richmond-Rakerd, Leah S.

2014-01-01

The ethical implications for psychological practice of genetic testing are largely unexplored. Predictive testing can have a significant impact on health and well-being, and increasing numbers of individuals with knowledge of their risk for various disorders are likely to present for psychotherapy. In addition, more people will struggle with the decision of whether to obtain information regarding their genetic material. Psychologists will need to have the appropriate knowledge and clinical skills to effectively counsel this population. This article highlights the relevant ethical issues surrounding psychological treatment of individuals pursuing or considering undergoing genetic testing. These issues are extended to psychologists working in research, education, and policy domains. Recommendations for graduate training programs to facilitate current and future practitioner competence are also discussed. PMID:24707160

Pre- and post-testing counseling considerations for the provision of expanded carrier screening: exploration of European geneticists' views.

PubMed

Janssens, Sandra; Chokoshvili, Davit; Vears, Danya F; De Paepe, Anne; Borry, Pascal

2017-08-01

Carrier screening is generally performed with the aim of identifying healthy couples at risk of having a child affected with a monogenic disorder to provide them with reproductive options. Expanded carrier screening (ECS), which provides the opportunity for multiple conditions to be screened in one test, offers a more cost-effective and comprehensive option than screening for single disorders. However, implementation of ECS at a population level would have implications for genetic counseling practice. We conducted semi-structured interviews with sixteen European clinical and molecular geneticists with expertise in carrier screening to explore their views on the implementation of ECS in the clinical setting. Using inductive content analysis, we identified content categories relevant to the pre- and post-test settings. Participants believed ECS would ideally be targeted at couples before pregnancy. There was some disagreement regarding the acceptability of performing ECS in individuals, with several participants actively opposing individual-based screening. In addition, participants discussed the importance of ensuring informed and voluntary participation in ECS, recommending measures to minimize external pressure on prospective parents to undergo testing. A need for adequate counseling to foster informed, autonomous reproductive decision-making and provide support for couples found to be at risk was emphasized. Practical challenges in optimizing pre-test education and post-test counseling should not be underestimated and they should be carefully addressed before implementing ECS in the clinical setting.

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

Low molecular weight heparins in the prevention of deep-vein thrombosis in general surgery.

PubMed

Breddin, H K

1999-01-01

Unfractionated heparin (UFH) was the established treatment in the early 1980s for the prophylaxis of venous thromboembolic disease (VTED) in patients undergoing general surgery. This was one of the earliest indications in which low molecular weight heparins (LMWHs) were tested, and about 40 trials have revealed that these agents are at least as effective and safe as UFH with a tendency of superiority when higher dosages are used. In most trials, the fibrinogen uptake test has been used to assess the frequency of deep vein thrombosis. LMWHs exhibit a number of improved features over UFH, including ease of administration and convenient once daily dosing, facilitating outpatient management. A still open question is the ideal time and dose of the first one or two injections of a LMWH. To determine the clinical relevance of product differentiation further, clinical trials, directly comparing different LMWHs, are required.

Evaluation of Genotypic and Phenotypic Protease Virulence Tests for Dichelobacter nodosus Infection in Sheep

PubMed Central

McPherson, Andrew S.; Dhungyel, Om P.

2017-01-01

ABSTRACT Dichelobacter nodosus is a fastidious, strictly anaerobic bacterium, an obligate parasite of the ruminant hoof, and the essential causative agent of virulent ovine footrot. The clinical disease results from a complex interplay between the pathogen, the environment, and the host. Sheep flocks diagnosed with virulent but not benign footrot in Australia may be quarantined and required to undergo a compulsory eradication program, with costs met by the farmer. Virulence of D. nodosus at least partially depends on the elaboration of a protease encoded by aprV2 and manifests as elastase activity. Laboratory virulence tests are used to assist diagnosis because clinical differentiation of virulent and benign footrot can be challenging during the early stages of disease or when the disease is not fully expressed due to unfavorable pasture conditions. Using samples collected from foot lesions from 960 sheep from 40 flocks in four different geographic regions, we evaluated the analytical characteristics of qPCR tests for the protease gene alleles aprV2 and aprB2, and compared these with results from phenotypic protease (elastase and gelatin gel) tests. There was a low level of agreement between clinical diagnosis and quantitative PCR (qPCR) test outcomes at both the flock and sample levels and poor agreement between qPCR test outcomes and the results of phenotypic virulence tests. The diagnostic specificity of the qPCR test was low at both the flock and individual swab levels (31.3% and 18.8%, respectively). By contrast, agreement between the elastase test and clinical diagnosis was high at both the flock level (diagnostic sensitivity [DSe], 100%; diagnostic specificity [DSp], 78.6%) and the isolate level (DSe, 69.5%; DSp, 80.5%). PMID:28202796

Evaluation of Genotypic and Phenotypic Protease Virulence Tests for Dichelobacter nodosus Infection in Sheep.

PubMed

McPherson, Andrew S; Dhungyel, Om P; Whittington, Richard J

2017-05-01

Dichelobacter nodosus is a fastidious, strictly anaerobic bacterium, an obligate parasite of the ruminant hoof, and the essential causative agent of virulent ovine footrot. The clinical disease results from a complex interplay between the pathogen, the environment, and the host. Sheep flocks diagnosed with virulent but not benign footrot in Australia may be quarantined and required to undergo a compulsory eradication program, with costs met by the farmer. Virulence of D. nodosus at least partially depends on the elaboration of a protease encoded by aprV2 and manifests as elastase activity. Laboratory virulence tests are used to assist diagnosis because clinical differentiation of virulent and benign footrot can be challenging during the early stages of disease or when the disease is not fully expressed due to unfavorable pasture conditions. Using samples collected from foot lesions from 960 sheep from 40 flocks in four different geographic regions, we evaluated the analytical characteristics of qPCR tests for the protease gene alleles aprV2 and aprB2 , and compared these with results from phenotypic protease (elastase and gelatin gel) tests. There was a low level of agreement between clinical diagnosis and quantitative PCR (qPCR) test outcomes at both the flock and sample levels and poor agreement between qPCR test outcomes and the results of phenotypic virulence tests. The diagnostic specificity of the qPCR test was low at both the flock and individual swab levels (31.3% and 18.8%, respectively). By contrast, agreement between the elastase test and clinical diagnosis was high at both the flock level (diagnostic sensitivity [DSe], 100%; diagnostic specificity [DSp], 78.6%) and the isolate level (DSe, 69.5%; DSp, 80.5%). Copyright © 2017 McPherson et al.

Comparative study of 2 electric and 2 manual toothbrushes in patients with fixed orthodontic appliances.

PubMed

Thienpont, V; Dermaut, L R; Van Maele, G

2001-10-01

The objective of this prospective single-blind crossover clinical trial was to evaluate the efficacy of 4 toothbrushes in 33 children undergoing fixed appliance orthodontic therapy. The toothbrushes included in this study were the Braun Oral-B 3D Plaque Remover (Kronberg, Germany), the Philips-Jordan HP 510 (Philips Domestic Appliances, Groningen, The Netherlands), the Lactona orthodontic toothbrush (Bergen op Zoom, The Netherlands), and the Oral-B Advantage Control Grip (Braun); the first 2 are electric, and the last 2 are manual. Every patient tested each type of toothbrush in a randomly designed sequence. Plaque and gingival scores were recorded at baseline and after every 4-week test period. All patients received professional prophylaxis after each clinical evaluation. The data were analyzed with the Friedman test, which showed no significant differences among the 4 brushes for any of the parameters measured. The Wilcoxon signed rank test, comparing the plaque and the gingival scores between the upper and lower jaw for each brush, indicated that plaque removal was more efficient in the lower jaw than in the upper.

Comparative evaluation of the results of three techniques in the reconstruction of the anterior cruciate ligament, with a minimum follow-up of two years.

PubMed

Cury, Ricardo de Paula Leite; Sprey, Jan Willem Cerf; Bragatto, André Luiz Lima; Mansano, Marcelo Valentim; Moscovici, Herman Fabian; Guglielmetti, Luiz Gabriel Betoni

2017-01-01

To compare the clinical results of the reconstruction of the anterior cruciate ligament by transtibial, transportal, and outside-in techniques. This was a retrospective study on 90 patients (ACL reconstruction with autologous flexor tendons) operated between August 2009 and June 2012, by the medial transportal (30), transtibial (30), and "outside-in" (30) techniques. The following parameters were assessed: objective and subjective IKDC, Lysholm, KT1000, Lachman test, Pivot-Shift and anterior drawer test. On physical examination, the Lachman test and Pivot-Shift indicated a slight superiority of the outside-in technique, but without statistical significance ( p  = 0.132 and p  = 0.186 respectively). The anterior drawer, KT1000, subjective IKDC, Lysholm, and objective IKDC tests showed similar results in the groups studied. A higher number of complications were observed in the medial transportal technique ( p  = 0.033). There were no statistically significant differences in the clinical results of patients undergoing reconstruction of the anterior cruciate ligament by transtibial, medial transportal, and outside-in techniques.

Impact of prior permanent pacemaker on long-term clinical outcomes of patients undergoing percutaneous coronary intervention.

PubMed

Li, Yan-Jie; Zhang, Wei-Wei; Yang, Xiao-Xiao; Li, Ning; Qiu, Xing-Biao; Qu, Xin-Kai; Fang, Wei-Yi; Yang, Yi-Qing; Li, Ruo-Gu

2017-04-01

The impact of permanent pacemaker (PPM) on long-term clinical outcomes of patients undergoing percutaneous coronary intervention (PCI) has not been studied. PPM may increase heart failure (HF) burden on patients undergoing PCI. We recruited consecutive patients undergoing PCI and carried out a nested case-control study. Patients with confirmed PPM undergoing first PCI were identified and matched by age and sex in 1:1 fashion to patients without PPM undergoing first PCI. Clinical data were collected and analyzed. The primary endpoint outcomes were all-cause mortality and hospitalization for HF. The final analysis included 156 patients. The mean follow-up period was 4.6 ± 2.9 years. The overall all-cause mortality was 21.15%, without significant difference between the 2 groups (21.79% vs 20.51%; P = 0.85). However, the rate of HF-related hospitalization was significantly higher in patients with PPM than in controls (26.92% vs 10.26%; P = 0.008). After adjustment for hypertension, type 2 diabetes mellitus, hyperlipidemia, chronic kidney disease, stroke, left ventricular ejection fraction, brain natriuretic peptide, and acute coronary syndrome (ACS), PCI patients with PPM were still associated with a greater hospitalization rate for HF (odds ratio: 4.31, 95% confidence interval: 0.94-19.80, P = 0.061). Further analysis in the ACS subgroup showed VVI-mode pacing enhanced the risk for HF-associated hospitalization (adjusted odds ratio: 8.27, 95% confidence interval: 1.37-49.75, P = 0.02). PPM has no effect on all-cause mortality in patients undergoing first PCI but significantly increases the HF-associated hospitalization rate, especially in ACS patients. © 2016 Wiley Periodicals, Inc.

Translation and testing of measurement properties of the Swedish version of the IKDC subjective knee form.

PubMed

Tigerstrand Grevnerts, H; Grävare Silbernagel, K; Sonesson, S; Ardern, C; Österberg, A; Gauffin, H; Kvist, J

2017-05-01

To translate to Swedish language and cross-culturally adapt the IKDC-SKF and to test the measurement properties of the Swedish version of IKDC-SKF in ACL-injured patients undergoing reconstruction surgery.The translation and cross-cultural adaption was performed according to guidelines. Seventy-six patients with an ACL injury filled out the IKDC-SKF and other questionnaires before ACL reconstruction and at 4, 6, and 12 months after surgery. A total of 203 patients from the Swedish ACL Registry participated at 8 months post-operative. Measurement properties were tested according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.The Swedish IKDC-SKF had high internal consistency (Cronbach's alpha=0.90) and test-retest reliability (ICC 2,1 =0.92, CI 95%: 0.81-0.97, P<.001). A single factor solution accounted for 46.1% of the variance in IKDC-SKF scores. Criterion validity was moderate to high. All ten predefined hypotheses for hypothesis testing were confirmed. The six hypotheses for responsiveness testing were confirmed. The effect size was 1.8, the standardized response mean was 1.9, the and minimal clinically important difference was 13.9 points.The Swedish version of the IKDC-SKF had good measurement properties and can be recommended for use in a population of ACL-deficient patients undergoing ACL reconstruction. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Risk Factors for Postoperative Respiratory Mortality and Morbidity in Patients Undergoing Coronary Artery Bypass Grafting

PubMed Central

Rajaei, Samira; Dabbagh, Ali

2012-01-01

ABSTRACT Nowadays, coronary artery bypass grafting (CABG) is considered to be one of the most common surgical procedures. This procedure has been the main topic in many clinical research studies, which have assessed the effect of the procedure on patients’ outcomes. Like other surgical procedures, this procedure is also accompanied by a number of unwanted complications, including those of the respiratory system. Since the respiratory system plays an integral role in defining the clinical outcome of patients, improvements in studies that can assess and predict clinical outcomes of the respiratory system, assume greater importance. There are a number of predictive models which can assess patients in the preoperative period and introduce a number of risk factors, which could be considered as prognostic factors for patients undergoing CABG. The respiratory system is among the clinical systems that are assessed in many prediction scoring systems. This review assesses the main studies which have evaluated the possible risk factors for postoperative respiratory mortality and morbidity, in patients undergoing CABG. PMID:24223339

Acute normovolemic hemodilution is safe in neurosurgery.

PubMed

Oppitz, Paulo P; Stefani, Marco A

2013-01-01

To determine the safety of acute normovolemic hemodilution (ANH) for patients undergoing neurosurgical procedures. A group of 100 patients undergoing neurosurgical procedures was assigned prospectively to receive ANH. A group of 47 patients who underwent craniotomy for aneurysm clipping and standard anesthetic management was used as a control. Procedures conducted under ANH were performed without significant variations in physiologic parameters. Compared with controls, intraoperative blood loss, operative time, incidence and grade of complications, and length of hospital stay were similar between the two groups. Although the ANH group showed a difference in prothrombin levels before and after hemodilution procedures, the levels were still considered within physiologic parameters. Platelet counts and partial thromboplastin time (PTT) levels indicated no significant variations in either group. During the ANH procedure, a considerable reduction of brain oxygen extraction was observed in individuals with worse preoperative neurologic status (P < 0.05), indicating potential benefit. Among patients with cerebral aneurysm, patients with good initial clinical grades had better clinical results as indicated by Glasgow Outcome Scale scores (P < 0.02). ANH is a safe procedure for patients undergoing neurosurgical procedures. Further studies are necessary to confirm the improvement in brain oxygen extraction and the clinical impact. Nonetheless, patients undergoing aneurysm clipping with good clinical grades seem to profit from ANH. Copyright © 2013 Elsevier Inc. All rights reserved.

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.

A model-based analysis of the clinical and economic impact of personalising P2Y12-receptor inhibition with platelet function testing in acute coronary syndrome patients.

PubMed

Straub, Niels; Beivers, Andreas; Lenk, Ekaterina; Aradi, Daniel; Sibbing, Dirk

2014-02-01

Although some observational studies reported that the measured level of P2Y12-inhibition is predictive for thrombotic events, the clinical and economic benefit of incorporating PFT to personalize P2Y12-receptor directed antiplatelet treatment is unknown. Here, we assessed the clinical impact and cost-effectiveness of selecting P2Y12-inhibitors based on platelet function testing (PFT) in acute coronary syndrome (ACS) patients undergoing PCI. A decision model was developed to analyse the health economic effects of different strategies. PFT-guided treatment was compared with the three options of general clopidogrel, prasugrel or ticagrelor treatment. In the PFT arm, low responders to clopidogrel received prasugrel, while normal responders carried on with clopidogrel. The associated endpoints in the model were cardiovascular death, stent thrombosis and major bleeding. With a simulated cohort of 10,000 patients treated for one year, there were 93 less events in the PFT arm compared to general clopidogrel. In prasugrel and ticagrelor arms, 110 and 86 events were prevented compared to clopidogrel treatment, respectively. The total expected costs (including event costs, drug costs and PFT costs) for generic clopidogrel therapy were US$ 1,059/patient. In the PFT arm, total costs were US$ 1,494, while in the prasugrel and ticagrelor branches they were US$ 3,102 and US$ 3,771, respectively. The incremental-cost-effectiveness-ratio (ICER) was US$ 46,770 for PFT-guided therapy, US$ 185,783 for prasugrel and US$ 315,360 for ticagrelor. In this model-based analysis, a PFT-guided therapy may have fewer adverse outcomes than general treatment with clopidogrel and may be more cost-effective than prasugrel or ticagrelor treatment in ACS patients undergoing PCI.

Parents perspectives on whole genome sequencing for their children: qualified enthusiasm?

PubMed

Anderson, J A; Meyn, M S; Shuman, C; Zlotnik Shaul, R; Mantella, L E; Szego, M J; Bowdin, S; Monfared, N; Hayeems, R Z

2017-08-01

To better understand the consequences of returning whole genome sequencing (WGS) results in paediatrics and facilitate its evidence-based clinical implementation, we studied parents' experiences with WGS and their preferences for the return of adult-onset secondary variants (SVs)-medically actionable genomic variants unrelated to their child's current medical condition that predict adult-onset disease. We conducted qualitative interviews with parents whose children were undergoing WGS as part of the SickKids Genome Clinic, a research project that studies the impact of clinical WGS on patients, families, and the healthcare system. Interviews probed parents' experience with and motivation for WGS as well as their preferences related to SVs. Interviews were analysed thematically. Of 83 invited, 23 parents from 18 families participated. These parents supported WGS as a diagnostic test, perceiving clear intrinsic and instrumental value. However, many parents were ambivalent about receiving SVs, conveying a sense of self-imposed obligation to take on the 'weight' of knowing their child's SVs, however unpleasant. Some parents chose to learn about adult-onset SVs for their child but not for themselves. Despite general enthusiasm for WGS as a diagnostic test, many parents felt a duty to learn adult-onset SVs. Analogous to 'inflicted insight', we call this phenomenon 'inflicted ought'. Importantly, not all parents of children undergoing WGS view the best interests of their child in relational terms, thereby challenging an underlying justification for current ACMG guidelines for reporting incidental secondary findings from whole exome and WGS. 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/.

A clinical study of the LiVac laparoscopic liver retractor system.

PubMed

Gan, Philip; Bingham, Judy

2016-02-01

All retractors for laparoscopic operations on the gallbladder or stomach apply an upward force to the under-surface of the liver or gallbladder, most requiring an additional skin incision. The LiVac laparoscopic liver retractor system (LiVac retractor) comprises a soft silicone ring attached to suction tubing and connected to a regulated source of suction. The suction tubing extends alongside existing ports. When placed between the liver and diaphragm, and suction applied, a vacuum is created within the ring, keeping these in apposition. Following successful proof-of-concept animal testing, a clinical study was conducted to evaluate the performance and safety of the retractor in patients. The study was a dual-centre, single-surgeon, open-label study and recruited ten patients scheduled to undergo routine upper abdominal laparoscopic surgery including cholecystectomy, primary gastric banding surgery or fundoplication. The study was conducted at two sites and was approved by the institutions' ethics committees. The primary objective of the study was to evaluate the performance of the LiVac retractor in patients undergoing upper abdominal single- or multi-port laparoscopic surgery. Performance was measured by the attainment of milestones for the retractor and accessory bevel, where used, and safety outcomes through the recording of adverse events, physical parameters, pain scales, blood tests and a post-operative liver ultrasound. The LiVac retractor achieved both primary and secondary performance and safety objectives in all patients. No serious adverse events and no device-related adverse events or device deficiencies were reported. The LiVac retractor achieved effective liver retraction without clinically significant trauma and has potential application in multi- or single-port laparoscopic upper abdominal surgery. As a separate incision is not required, the use of the LiVac retractor in multi-port surgery therefore reduces the number of incisions.

Pre- and post-test genetic counseling for chromosomal and Mendelian disorders.

PubMed

Fonda Allen, Jill; Stoll, Katie; Bernhardt, Barbara A

2016-02-01

Genetic carrier screening, prenatal screening for aneuploidy, and prenatal diagnostic testing have expanded dramatically over the past 2 decades. Driven in part by powerful market forces, new complex testing modalities have become available after limited clinical research. The responsibility for offering these tests lies primarily on the obstetrical care provider and has become more burdensome as the number of testing options expands. Genetic testing in pregnancy is optional, and decisions about undergoing tests, as well as follow-up testing, should be informed and based on individual patients' values and needs. Careful pre- and post-test counseling is central to supporting informed decision-making. This article explores three areas of technical expansion in genetic testing: expanded carrier screening, non-invasive prenatal screening for fetal aneuploidies using cell-free DNA, and diagnostic testing using fetal chromosomal microarray testing, and provides insights aimed at enabling the obstetrical practitioner to better support patients considering these tests. Copyright © 2016 Elsevier Inc. All rights reserved.

Tumor genome analysis includes germline genome: Are we ready for surprises?

PubMed Central

Catenacci, Daniel VT; Amico, Andrea L; Nielsen, Sarah M; Geynisman, Daniel M; Rambo, Brittany; Carey, George B; Gulden, Cassandra; Fackenthal, Jim; Marsh, Robert D; Kindler, Hedy L; Olopade, Olufunmilayo I

2015-01-01

We sought to describe the spectrum of potential and confirmed germline genomic events incidentally identified during routine medium-throughput somatic tumor DNA sequencing, and to provide a framework for pre- and post-test consent and counseling for patients and families. Targeted tumor-only next-generation sequencing (NGS) had been used to evaluate for possible druggable genomic events obtained from consecutive new patients with metastatic gastroesophageal, hepatobiliary or colorectal cancer seen at the University of Chicago. A panel of medical oncologists, cancer geneticists and genetic counselors retrospectively grouped these patients (N = 111) based on probability of possessing a potentially inherited mutation in a cancer susceptibility gene, both prior to and after incorporating tumor-only NGS results. High-risk patients (determined from NGS results) were contacted and counseled in person by a genetic counselor (N = 21). When possible and indicated, germline genetic testing was offered. Of 8 evaluable high-risk patients, 7 underwent germline testing. Three (37.5%) had confirmed actionable germline mutations (all in the BRCA2 gene). NGS offers promise, but poses significant challenges for oncologists who are ill prepared to handle incidental findings that have clinical implications for at risk family members. In this relatively small cohort of patients undergoing tumor genomic testing for gastrointestinal malignancies, we incidentally identified 3 BRCA2 mutations carriers. This report underscores the need for oncologists to develop a framework for pre- and post-test communication of risks to patients undergoing routine tumor-only sequencing. What's new? High-throughput, ‘next-generation sequencing’ (NGS) allows millions of DNA strands to be sequenced in parallel. NGS is increasingly used to test tumors for mutations that may guide therapy. Sometimes, however, this testing can reveal mutations that are known to be inherited, which means that family members are also at increased risk for cancer. How should this information be presented? This article underscores the need for oncologists to develop a framework for pre- and post-test communication and counseling regarding risk for patients undergoing tumor-only sequencing. PMID:25123297

Patients' Willingness to Participate in Rapid HIV Testing: A pilot study in three New York City dental hygiene clinics.

PubMed

Davide, Susan H; Santella, Anthony J; Furnari, Winnie; Leuwaisee, Petal; Cortell, Marilyn; Krishnamachari, Bhuma

2017-12-01

Purpose: One in eight people living with an HIV infection in the United States is unaware of their status. Rapid HIV testing (RHT) is an easily used and accepted screening tool that has been introduced in a limited number of clinical settings. The purpose of this study was to investigate patient acceptability, certainty of their decision, and willingness to pay for screening if RHT was offered in university-based dental hygiene clinics. Methods: A cross-sectional survey was administered to 426 patients at three dental hygiene clinics in New York City over a period of four months. The survey questionnaire was based on the decisional conflict scale measuring personal perceptions; with zero indicating extremely high conflict to four indicating no conflict. Patients were assessed for their acceptance of RHT, provider preference for administration of the test and their willingness to pay for RHT. Results: Over half (72.2%) indicated acceptance of HIV testing in a dental hygiene clinic setting; with 85.3% choosing oral RHT, 4.9% fingerstick RHT, and 8.8% venipuncture. Respondents were amenable to testing when offered by dental hygienists (71.7%) and dentists (72.4%). Over 30% indicated their willingness to receive HIV testing in the dental setting when offered at no additional cost. The mean decisional conflict score was 3.42/4.0 indicating no decisional conflict. Conclusions: Patients are willing to undergo oral RHT when offered as a service and provided by dental hygienists in the dental setting. Patients appear to be aware of the benefits and risks associated with RHT. Further research is needed to evaluate the public health benefits and logistical challenges facing the delivery of RHT within in the dental setting. Copyright © 2017 The American Dental Hygienists’ Association.

Development of a clinical decision model for thyroid nodules.

PubMed

Stojadinovic, Alexander; Peoples, George E; Libutti, Steven K; Henry, Leonard R; Eberhardt, John; Howard, Robin S; Gur, David; Elster, Eric A; Nissan, Aviram

2009-08-10

Thyroid nodules represent a common problem brought to medical attention. Four to seven percent of the United States adult population (10-18 million people) has a palpable thyroid nodule, however the majority (>95%) of thyroid nodules are benign. While, fine needle aspiration remains the most cost effective and accurate diagnostic tool for thyroid nodules in current practice, over 20% of patients undergoing FNA of a thyroid nodule have indeterminate cytology (follicular neoplasm) with associated malignancy risk prevalence of 20-30%. These patients require thyroid lobectomy/isthmusectomy purely for the purpose of attaining a definitive diagnosis. Given that the majority (70-80%) of these patients have benign surgical pathology, thyroidectomy in these patients is conducted principally with diagnostic intent. Clinical models predictive of malignancy risk are needed to support treatment decisions in patients with thyroid nodules in order to reduce morbidity associated with unnecessary diagnostic surgery. Data were analyzed from a completed prospective cohort trial conducted over a 4-year period involving 216 patients with thyroid nodules undergoing ultrasound (US), electrical impedance scanning (EIS) and fine needle aspiration cytology (FNA) prior to thyroidectomy. A Bayesian model was designed to predict malignancy in thyroid nodules based on multivariate dependence relationships between independent covariates. Ten-fold cross-validation was performed to estimate classifier error wherein the data set was randomized into ten separate and unique train and test sets consisting of a training set (90% of records) and a test set (10% of records). A receiver-operating-characteristics (ROC) curve of these predictions and area under the curve (AUC) were calculated to determine model robustness for predicting malignancy in thyroid nodules. Thyroid nodule size, FNA cytology, US and EIS characteristics were highly predictive of malignancy. Cross validation of the model created with Bayesian Network Analysis effectively predicted malignancy [AUC = 0.88 (95%CI: 0.82-0.94)] in thyroid nodules. The positive and negative predictive values of the model are 83% (95%CI: 76%-91%) and 79% (95%CI: 72%-86%), respectively. An integrated predictive decision model using Bayesian inference incorporating readily obtainable thyroid nodule measures is clinically relevant, as it effectively predicts malignancy in thyroid nodules. This model warrants further validation testing in prospective clinical trials.

Variation in Screening Abnormality Rates and Follow-Up of Breast, Cervical and Colorectal Cancer Screening within the PROSPR Consortium.

PubMed

Tosteson, Anna N A; Beaber, Elisabeth F; Tiro, Jasmin; Kim, Jane; McCarthy, Anne Marie; Quinn, Virginia P; Doria-Rose, V Paul; Wheeler, Cosette M; Barlow, William E; Bronson, Mackenzie; Garcia, Michael; Corley, Douglas A; Haas, Jennifer S; Halm, Ethan A; Kamineni, Aruna; Rutter, Carolyn M; Tosteson, Tor D; Trentham-Dietz, Amy; Weaver, Donald L

2016-04-01

Primary care providers and health systems have prominent roles in guiding effective cancer screening. To characterize variation in screening abnormality rates and timely initial follow-up for common cancer screening tests. Population-based cohort undergoing screening in 2011, 2012, or 2013 at seven research centers comprising the National Cancer Institute-sponsored Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) consortium. Adults undergoing mammography with or without digital breast tomosynthesis (n = 97,683 ages 40-75 years), fecal occult blood or fecal immunochemical tests (n = 759,553 ages 50-75 years), or Papanicolaou with or without human papillomavirus tests (n = 167,330 ages 21-65 years). Breast, colorectal, or cervical cancer screening. Abnormality rates per 1000 screens; percentage with timely initial follow-up (within 90 days, except 9-month window for BI-RADS 3). Primary care clinic-level variation in percentage with screening abnormality and percentage with timely initial follow-up. There were 10,248/97,683 (104.9 per 1000) abnormal breast cancer screens, 35,847/759,553 (47.2 per 1000) FOBT/FIT-positive colorectal cancer screens, and 13,266/167,330 (79.3 per 1000) abnormal cervical cancer screens. The percentage with timely follow-up was 93.2 to 96.7 % for breast centers, 46.8 to 68.7  % for colorectal centers, and 46.6 % for the cervical cancer screening center (low-grade squamous intraepithelial lesions or higher). The primary care clinic variation (25th to 75th percentile) was smaller for the percentage with an abnormal screen (breast, 8.5-10.3 %; colorectal, 3.0-4.8 %; cervical, 6.3-9.9 %) than for the percentage with follow-up within 90 days (breast, 90.2-95.8 %; colorectal, 43.4-52.0 %; cervical, 29.6-61.4 %). Variation in both the rate of screening abnormalities and their initial follow-up was evident across organ sites and primary care clinics. This highlights an opportunity for improving the delivery of cancer screening through focused study of patient, provider, clinic, and health system characteristics associated with timely follow-up of screening abnormalities.

Successful use of nitrous oxide during lumbar punctures: A call for nitrous oxide in pediatric oncology clinics.

PubMed

Livingston, Mylynda; Lawell, Miranda; McAllister, Nancy

2017-11-01

Numerous reports describe the successful use of nitrous oxide for analgesia in children undergoing painful procedures. Although shown to be safe, effective, and economical, nitrous oxide use is not yet common in pediatric oncology clinics and few reports detail its effectiveness for children undergoing repeated lumbar punctures. We developed a nitrous oxide clinic, and undertook a review of pediatric oncology lumbar puncture records for those patients receiving nitrous oxide in 2011. No major complications were noted. Minor complications were noted in 2% of the procedures. We offer guidelines for establishing such a clinic. © 2017 Wiley Periodicals, Inc.

Adolescent bariatric surgery program characteristics: the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study experience.

PubMed

Michalsky, Marc P; Inge, Thomas H; Teich, Steven; Eneli, Ihuoma; Miller, Rosemary; Brandt, Mary L; Helmrath, Michael; Harmon, Carroll M; Zeller, Meg H; Jenkins, Todd M; Courcoulas, Anita; Buncher, Ralph C

2014-02-01

The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Data were obtained from the Teen-LABS database, and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. All centers had extensive multidisciplinary involvement in the assessment, pre-operative education, and post-operative management of adolescents undergoing WLS. Eligibility criteria and pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well-developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. The composition of clinical team and institutional resources is consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. © 2013 Published by Elsevier Inc.

Adolescent Bariatric Surgery Program Characteristics: The Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Study Experience

PubMed Central

Michalsky, M.P.; Inge, T.H.; Teich, S.; Eneli, I.; Miller, R.; Brandt, M.L.; Helmrath, M.; Harmon, C.M.; Zeller, M.H.; Jenkins, T.M.; Courcoulas, A.; Buncher, C.R.

2013-01-01

Background The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Methods Data were obtained from the Teen-LABS database and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. Results All centers had extensive multidisciplinary involvement in the assessment, preoperative education and post-operative management of adolescents undergoing WLS. Eligibility criteria, pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. Conclusions The composition of clinical team and institutional resources are consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. PMID:24491361

Comparison of the changes in blood glucose level during sedation with midazolam and propofol in implant surgery: a prospective randomized clinical trial.

PubMed

Kaviani, Nasser; Koosha, Farzad; Shahtusi, Mina

2014-09-01

Reducing the patients' stress can prevent, or at least, limit the increase in blood glucose level. The study compares the effect of propofol and midazolam on blood glucose level in the patients undergoing dental implant surgery. The effect of pre-operational stress on blood glucose level during the surgery is also evaluated. This prospective randomized clinical trial recruited 33 patients undergoing dental implant surgery and divided into two groups. Conscious sedation was performed by midazolam in one group and with propofol in another group. The pre-operational stress was scored and the blood glucose level was measured in 4 different stages; before the operation, two minutes after the local anesthetic injection; thirty minutes after the onset of operation and at the end of the operation. The results were analyzed by employing ANOVA and Pearson test. The p Value was adopted 0.05 and the confidence coefficient was assumed 95%. The average levels of the blood glucose in midazolam and propofol group were 93.82 mg/dl and 94 mg/dl before the operation which displayed a meaningful increase of blood glucose level in both groups as the operation went on. The values were 103.76 mg/dl for midazolam and 108.56 mg/dl for the propofol group (p< 0.05) at the end of the operation. No statistically significant difference was found in the average blood glucose level between two groups in the different stages of the operation (p= 0.466). The Pearson correlation coefficient test revealed a higher increase in the blood glucose level in the patients with a higher pre-operational stress score (r= 0.756, p< 0.001). Based on the results yielded by this study, patients who receive venous sedation, either by midazolam or propofol, experience increase in the blood glucose level while undergoing an operation. No statistically significant difference was detected between midazolam and propofol.

Clinical laboratory: bigger is not always better.

PubMed

Plebani, Mario

2018-06-27

Laboratory services around the world are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing, primarily based on expectations to improve efficiency, increasing volumes and reducing the cost per test. However, the relationship between volume and costs is not linear and numerous variables influence the end cost per test. In particular, the relationship between volumes and costs does not span the entire platter of clinical laboratories: high costs are associated with low volumes up to a threshold of 1 million test per year. Over this threshold, there is no linear association between volumes and costs, as laboratory organization rather than test volume more significantly affects the final costs. Currently, data on laboratory errors and associated diagnostic errors and risk for patient harm emphasize the need for a paradigmatic shift: from a focus on volumes and efficiency to a patient-centered vision restoring the nature of laboratory services as an integral part of the diagnostic and therapy process. Process and outcome quality indicators are effective tools to measure and improve laboratory services, by stimulating a competition based on intra- and extra-analytical performance specifications, intermediate outcomes and customer satisfaction. Rather than competing with economic value, clinical laboratories should adopt a strategy based on a set of harmonized quality indicators and performance specifications, active laboratory stewardship, and improved patient safety.

The Aerostructures Test Wing (ATW) experiment, which consisted of an 18-inch carbon fiber test wing with surface-mounted piezoelectric strain actuators, undergoing ground testing prior to flight on Dryden's F-15B Research Testbed aircraft

NASA Image and Video Library

2001-03-28

The Aerostructures Test Wing (ATW) experiment, which consisted of an 18-inch carbon fiber test wing with surface-mounted piezoelectric strain actuators, undergoing ground testing prior to flight on Dryden's F-15B Research Testbed aircraft

Raman spectroscopy of stored red blood cells: evaluating clinically-relevant biochemical markers in donated blood

NASA Astrophysics Data System (ADS)

Atkins, Chad G.; Buckley, Kevin; Chen, Deborah; Schulze, H. G.; Devine, Dana V.; Blades, Michael W.; Turner, Robin F. B.

2015-07-01

Modern transfusion medicine relies on the safe, secure, and cost-effective delivery of donated red blood cells (RBCs). Once isolated, RBCs are suspended in a defined additive solution and stored in plastic blood bags in which, over time, they undergo chemical, physiological, and morphological changes that may have a deleterious impact on some patients. Regulations limit the storage period to 42 days and the cells do not routinely undergo analytical testing before use. In this study, we use Raman spectroscopy to interrogate stored RBCs and we identify metabolic and cell-breakdown products, such as haemoglobin and membrane fragments, that build-up in the blood bags as the cells age. Our work points the way to the development of an instrument which could quickly and easily assess the biochemical nature of stored RBC units before they are transfused.

Autogenic training reduces anxiety after coronary angioplasty: a randomized clinical trial.

PubMed

Kanji, N; White, A R; Ernst, E

2004-03-01

Autogenic training (AT) is a method of autosuggestion with some potential for reducing anxiety. This study tests whether AT lowers anxiety levels experienced by patients undergoing coronary angioplasty. Fifty-nine patients were randomly assigned to receive regular AT or no such therapy as an adjunct to standard care for 5 months. The primary outcome measure was State Anxiety at 2 months. Qualitative information was generated by face-to-face interviews. State Anxiety showed a significant intergroup difference both at 2 and 5 months. This finding was corroborated by secondary outcome measures, for example, quality of life, and by qualitative information about patients' experiences. The results do not allow us to determine whether the observed effects are specific to AT or of a nonspecific nature. Our results suggest that AT may have a role in reducing anxiety of patients undergoing coronary angioplasty.

Self-reported use of complementary and alternative medicine therapies in a reflexology randomized clinical trial.

PubMed

Wyatt, Gwen; Sikorskii, Alla; You, Mei

2013-01-01

According to the National Center for Complementary and Alternative Medicine (NCCAM), about one-third of American cancer patients have used complementary and alternative medicine (CAM). The objective of this secondary analysis was an assessment of the use of other CAM by women with advanced breast cancer who were undergoing chemotherapy and who participated in a randomized clinical trial (RCT) studying the safety and efficacy of reflexology. For this secondary analysis, the research team hypothesized an increased CAM use due to exposure to the reflexology trial. For this secondary analysis, the team conducted telephone interviews at baseline, wk 5, and wk 11 to assess the use of 23 common CAM therapies. The study took place at 14 medical oncology clinics across the Midwestern United States. Participants included women with advanced breast cancer who were undergoing chemotherapy and/or hormonal therapy. In the study related to this secondary analysis, the research team randomly assigned the women to one of three primary groups: (1) reflexology; (2) lay foot manipulation (LFM); and (3) control. In addition, the research team used two test groups to establish the study's protocol: (1) test reflexology and (2) test LFM. For this secondary analysis, the research team considered the two reflexology groups (test and intervention) and the two LFM groups (test and intervention) to be the active groups, comparing their use of CAM to the control group's use at the selected time points. The research team used a linear, mixed-effects model to analyze the number of therapies used at the three time points. The team performed t tests to compare therapy use at baseline for those women who completed the study vs those who dropped out. The team used the CAM-use instrument. In total, 385 women participated. The research team found no differences in CAM use for the active groups vs the control group over time or in those women who stayed in the study vs those who dropped out. The team found an increase in CAM use at wk 5 compared to baseline, followed by a decrease at wk 11; however, the time trends were the same in the active groups and the control group In women with advanced breast cancer, researchers can rely upon one assessment of CAM use during an RCT of a CAM therapy.

From 200 BC to 2015 AD: an integration of robotic surgery and Ayurveda/Yoga

PubMed Central

Pillai, Geethakrishnan Gopalakrishna

2016-01-01

Background Among the traditional systems of medicine practiced all over the world, Ayurveda and Yoga has a documented history dating back to beyond 200 BC. Robotic and video assisted thoracic surgery (VATS) is an invention of the 21st century. We aim to quantify the effects of integration of Ayurveda and Yoga on patients undergoing minimally invasive robotic and VATS. Methods Four hundred and fifty-four patients undergoing VATS and robotic thoracic surgery were introduced to a pre and postoperative protocol of Yoga therapy, mediation and oil massages. Yoga exercises included Pranayam, Anulom Vilom, and Oil Massages included Urotarpan. Preoperative and postoperative respiratory functions were recorded. Patient satisfaction questionnaire were noted. Statistical comparison was made to control group undergoing minimally invasive thoracic surgery without integrative medicine. Only one patient refused to undergo Ayurveda therapy and was deleted from the group. Results Acceptability was high among all patients. Preoperative training led to implementation as early as 6 hours post surgery. Pulmonary function test showed significant improvement. All patients suggested an improvement in satisfaction score. Pain score were less in study patients. Quicker mobilization led to early discharge and drain removal. Chronic pain was prevented in patients having oil massages over the healed wound sites. Conclusions Integration of Ayurveda, Yoga and minimally invasive robotic and VATS is acceptable to Indian patients and gives better clinical results and higher patient satisfaction. PMID:26941975

Is it time to sound an alarm about false-positive cell-free DNA testing for fetal aneuploidy?

PubMed

Mennuti, Michael T; Cherry, Athena M; Morrissette, Jennifer J D; Dugoff, Lorraine

2013-11-01

Testing cell-free DNA (cfDNA) in maternal blood samples has been shown to have very high sensitivity for the detection of fetal aneuploidy with very low false-positive results in high-risk patients who undergo invasive prenatal diagnosis. Recent observation in clinical practice of several cases of positive cfDNA tests for trisomy 18 and trisomy 13, which were not confirmed by cytogenetic testing of the pregnancy, may reflect a limitation of the positive predictive value of this quantitative testing, particularly when it is used to detect rare aneuploidies. Analysis of a larger number of false-positive cases is needed to evaluate whether these observations reflect the positive predictive value that should be expected. Infrequently, mechanisms (such as low percentage mosaicism or confined placental mosaicism) might also lead to positive cfDNA testing that is not concordant with standard prenatal cytogenetic diagnosis. The need to explore these and other possible causes of false-positive cfDNA testing is exemplified by 2 of these cases. Additional evaluation of cfDNA testing in clinical practice and a mechanism for the systematic reporting of false-positive and false-negative cases will be important before this test is offered widely to the general population of low-risk obstetric patients. In the meantime, incorporating information about the positive predictive value in pretest counseling and in clinical laboratory reports is recommended. These experiences reinforce the importance of offering invasive testing to confirm cfDNA results before parental decision-making. Copyright © 2013 Mosby, Inc. All rights reserved.

Evaluation of sedation for standing clinical procedures in horses using detomidine combined with buprenorphine.

PubMed

Taylor, Polly; Coumbe, Karen; Henson, Frances; Scott, David; Taylor, Alan

2014-01-01

To examine the effect of including buprenorphine with detomidine for sedation of horses undergoing clinical procedures. Partially blinded, randomised, prospective clinical field trial. Eighty four client-owned horses scheduled for minor surgery or diagnostic investigation under standing sedation. The effects of buprenorphine (5 μg kg(-1) ) (Group B, n = 46) or placebo (5% glucose solution) (Group C, n = 38) in combination with detomidine (10 μg kg(-1) ) were compared in standing horses undergoing minor clinical procedures. The primary outcome measure was successful completion of the procedure. The degree of sedation and ataxia were scored using simple descriptive scales. Heart and respiratory rates were recorded at 15-30 minute intervals. Parametric data from each group were compared using anova or t-test and non parametric data using the Mann-Whitney U test. The procedure was carried out successfully in 91% of Group B and 63% of Group C (p < 0.01). Repeat dosing was required in 24% of Group B and 32% of Group C (p < 0.05). Sedation was more profound and lasted longer (60 versus 45 minutes) in Group B (p < 0.01). Ataxia occurred after detomidine, increased after buprenorphine but not glucose administration, was more profound in group B and lasted longer (60 versus 30 minutes) p < 0.001). Heart and respiratory rates remained within normal limits in both groups and there were no serious adverse events. Buprenorphine 5 and 10 μg kg(-1) enhanced the sedation produced by detomidine 10 and 20 μg kg(-1) with minor side effects similar to other alpha2 agonist/opioid combinations. Detomidine-buprenorphine sedation is suitable for standing procedures in horses. © 2013 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia.

The use of mystery shopping for quality assurance evaluations of HIV/STI testing sites offering services to young gay and bisexual men.

PubMed

Bauermeister, José A; Pingel, Emily S; Jadwin-Cakmak, Laura; Meanley, Steven; Alapati, Deepak; Moore, Michael; Lowther, Matthew; Wade, Ryan; Harper, Gary W

2015-10-01

Young men who have sex with men (YMSM) are at increased risk for HIV and STI infection. While encouraging HIV and STI testing among YMSM remains a public health priority, we know little about the cultural competency of providers offering HIV/STI tests to YMSM in public clinics. As part of a larger intervention study, we employed a mystery shopper methodology to evaluate the LGBT cultural competency and quality of services offered in HIV and STI testing sites in Southeast Michigan (n = 43).We trained and deployed mystery shoppers (n = 5) to evaluate the HIV and STI testing sites by undergoing routine HIV/STI testing. Two shoppers visited each site, recording their experiences using a checklist that assessed 13 domains, including the clinic's structural characteristics and interactions with testing providers. We used the site scores to examine the checklist's psychometric properties and tested whether site evaluations differed between sites only offering HIV testing (n = 14) versus those offering comprehensive HIV/STI testing (n = 29). On average, site scores were positive across domains. In bivariate comparisons by type of testing site, HIV testing sites were more likely than comprehensive HIV/STI testing clinics to ascertain experiences of intimate partner violence, offer action steps to achieve safer sex goals, and provide safer sex education. The developed checklist may be used as a quality assurance indicator to measure HIV/STI testing sites' performance when working with YMSM. Our findings also underscore the need to bolster providers' provision of safer sex education and behavioral counseling within comprehensive HIV/STI testing sites.

Development of an Attitudes Measure for Prenatal Screening in Diverse Populations

ERIC Educational Resources Information Center

Posner, S. F.; Learman, L. A.; Gates, E. A.; Washington, A. E.; Kuppermann, M.

2004-01-01

Background: Prenatal screening for chromosomal abnormalities is routinely offered to all pregnant women who present for care by their 20th gestational week. Not all women, however, choose to undergo one of these tests, and choice of which test(s) to undergo also vary. The reasons for variation in screening test behavior have not been fully…

Is personalized medicine achievable in obstetrics?

PubMed

Quinney, Sara K; Patil, Avinash S; Flockhart, David A

2014-12-01

Personalized medicine seeks to identify the right dose of the right drug for the right patient at the right time. Typically, individualization of therapy is based on the pharmacogenomic makeup of the individual and environmental factors that alter drug disposition and response. In addition to these factors, during pregnancy, a woman's body undergoes many changes that can impact the therapeutic efficacy of medications. Yet, there is minimal research regarding personalized medicine in obstetrics. Adoption of pharmacogenetic testing into the obstetrical care is dependent on evidence of analytical validity, clinical validity, and clinical utility. Here, we briefly present information regarding the potential utility of personalized medicine for treating the obstetric patient for pain with narcotics, hypertension, and preterm labor, and discuss the impediments of bringing personalized medicine to the obstetrical clinic. Copyright © 2014 Elsevier Inc. All rights reserved.

The economics of recovery after pancreatic surgery: detailed cost minimization analysis of an enhanced recovery program.

PubMed

Kagedan, Daniel J; Devitt, Katharine S; Tremblay St-Germain, Amélie; Ramjaun, Aliya; Cleary, Sean P; Wei, Alice C

2017-11-01

Clinical pathways (CPW) are considered safe and effective at decreasing postoperative length of stay (LoS), but the effect on economic costs is uncertain. This study sought to elucidate the effect of a CPW on direct hospitalization costs for patients undergoing pancreaticoduodenectomy (PD). A CPW for PD patients at a single Canadian institution was implemented. Outcomes included LoS, 30-day readmissions, and direct costs of hospital care. A retrospective cost minimization analysis compared patients undergoing PD prior to and following CPW implementation, using a bootstrapped t test and deviation-based cost modeling. 121 patients undergoing PD after CPW implementation were compared to 74 controls. Index LoS was decreased following CPW implementation (9 vs. 11 days, p = 0.005), as was total LoS (10 vs. 11 days, p = 0.003). The mean total cost of postoperative hospitalization per patient decreased in the CPW group ($15,678.45 CAD vs. $25,732.85 CAD, p = 0.024), as was the mean 30-day cost including readmissions ($16,627.15 CAD vs. $29,872.72 CAD, p = 0.016). Areas of significant cost savings included laboratory tests and imaging investigations. CPWs may generate cost savings by reducing unnecessary investigations, and improve quality of care through process standardization and decreasing practice variation. Copyright © 2017 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

[Rumination syndrome: Diagnostic and therapeutic difficulties of a not so uncommon disorder].

PubMed

Giménez Casado, Aida; López Liñán, María José; Barba Orozco, Elisabeth; Accarino Garaventa, Anna; Álvarez Beltrán, Marina; Azpiroz Vidaur, Fernando; Segarra Cantón, Oscar

2018-02-01

Rumination syndrome is an uncommon gastrointestinal functional disorder that may be difficult to diagnose, as not many physicians are aware of this condition. In many cases, patients undergo numerous tests and are prescribed several treatments based on erroneous diagnoses. When the correct diagnosis is eventually made, therapy for the syndrome can be difficult and complex because of its multifactorial nature. The aim of this study was to present our experience with this condition, by presenting an analysis of the clinical, diagnostic, and therapeutic data of our patients. A prospective and retrospective study was conducted on all cases of rumination syndrome diagnosed between January 2010 and May 2016 in patients attending the Paediatric Gastroenterology Departments of two hospitals: Consorci Sanitari de Terrassa and Hospital Materno-Infantil Vall d'Hebron (Barcelona, Spain). The analysis included 12 patients, with a mean age at the onset of symptoms of 9 years and 1 month, and the mean time period to make the diagnosis was 2 years and 3 months. A mean of 8.1 complementary tests were carried out before establishing the diagnosis. In 10 of the 12 patients, some type of treatment had been given before the diagnosis of rumination syndrome, but was unsuccessful in all cases. Ten of our patients underwent the novel, experimental biofeedback therapy. Due to the limited knowledge of this condition among attending professionals in terms of the clinical presentation, diagnosis, and treatment, patients with rumination syndrome are often misdiagnosed and undergo numerous avoidable complementary tests, and invasive, costly treatments. Copyright © 2017 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

Family-Centered Education and Its Clinical Outcomes in Patients Undergoing Hemodialysis Short Running

PubMed Central

Bahramnezhad, Fatemeh; Asgari, Parvaneh; Zolfaghari, Mitra; Farokhnezhad Afshar, Pouya

2015-01-01

Background: Poor adherence to treatment in patients undergoing hemodialysis leads to many complications, including death of the patient. Objectives: This study was aimed to investigate the effect of family-based training on common side-effects during dialysis. Patients and Methods: The present randomized controlled trial study was conducted on 60 patients undergoing hemodialysis at hospitals of Tehran University of Medical Sciences, Iran, from May 2012 to October 2012. Samples were randomly divided into two groups of patient-education (n = 30) and education of patient associated with an active member of the family (n = 30). Blood pressure, chest pain, nausea, vomiting, headaches and muscle cramps were followed with a check list and a questionnaire. The frequencies of the abovementioned complications at the mentioned intervals were recorded in three stages (before the intervention as well as two and four weeks after the intervention). Data analysis was performed using SPSS software, version 16, with chi-square test, Fisher’s exact test and independent t-test. Results: The mean ages of the patients in patient-centered and the family-oriented groups were 47.41 ± 10.31 and 48.16 ± 9.21, respectively. The result showed that some of the variables such as chest pain (P = 0.50, P = 0.01), nausea (P = 0.50, P = 0.01), headache (P = 0.81, P = 0.016), and blood pressure (P = 0.91, P = 0.016) were statistically significant before and four weeks after the intervention. Conclusions: According to the result of this study, the presence of families in a treatment plan could be essential to follow the treatment plan and subsequently reduced the complications of hemodialysis. PMID:26290749

What is the safety of nonemergent operative procedures performed at night? A study of 10,426 operations at an academic tertiary care hospital using the American College of Surgeons national surgical quality program improvement database.

PubMed

Turrentine, Florence E; Wang, Hongkun; Young, Jeffrey S; Calland, James Forrest

2010-08-01

Ever-increasing numbers of in-house acute care surgeons and competition for operating room time during normal daytime business hours have led to an increased frequency of nonemergent general and vascular surgery procedures occurring at night when there are fewer residents, consultants, nurses, and support staff available for assistance. This investigation tests the hypothesis that patients undergoing such procedures after hours are at increased risk for postoperative morbidity and mortality. Clinical data for 10,426 operative procedures performed over a 5-year period at a single academic tertiary care hospital were obtained from the American College of Surgeons National Surgical Quality Improvement Program Database. The prevalence of preoperative comorbid conditions, postoperative length of stay, morbidity, and mortality was compared between two cohorts of patients: one who underwent nonemergent operative procedures at night and other who underwent similar procedures during the day. Subsequent statistical comparisons utilized chi tests for comparisons of categorical variables and F-tests for continuous variables. Patients undergoing procedures at night had a greater prevalence of serious preoperative comorbid conditions. Procedure complexity as measured by relative value unit did not differ between groups, but length of stay was longer after night procedures (7.8 days vs. 4.3 days, p < 0.0001). Patients undergoing nonemergent general and vascular surgery procedures at night in an academic medical center do not seem to be at increased risk for postoperative morbidity or mortality. Performing nonemergent procedures at night seems to be a safe solution for daytime overcrowding of operating rooms.

Comparing Hemodynamic Symptoms and the Level of Abdominal Pain in High- Versus Low-Pressure Carbon Dioxide in Patients Undergoing Laparoscopic Cholecystectomy.

PubMed

Mohammadzade, A R; Esmaili, F

2018-02-01

The laparoscopic cholecystectomy (LC) is the gold standard to treat gallstone. To view the surgical site in this type of operations better, carbon dioxide is used with a certain pressure. The current study aimed to compare the hemodynamic symptoms and the level of abdominal pain due to using high- and low-pressure carbon dioxide in patients undergoing LC. The current double-blind randomized clinical trial was conducted on 60 patients with the age range of 20-70 years old undergoing LC. The first and second groups experienced PaCO 2 of 7-10 and 12-14 mmHg, respectively. The hemodynamic symptoms, abdominal pain, shoulder-tip pain, nausea and vomiting after the surgery, and the mean of liver function tests were evaluated. Data were analyzed using T test, Chi-square test, and repeated measures ANOVA by SPSS 16. Information of 60 patients in two groups was analyzed. There was a significant difference between the groups regarding the mean of systolic blood pressure ( P  < 0.05). The mean of heart rate was significantly higher in the high-pressure group during surgery and 1 h after that ( P  < 0.05). The frequency of pain in shoulder-tip and abdomen was higher in the high-pressure group. Frequency of nausea and vomiting 12 h after the surgery between two groups was significant ( P  < 0.05). The mean of alkaline phosphatase was higher in the low-pressure group than the high-pressure group ( P  < 0.05). Considering the good performance and low side effects of low-pressure laparoscopic cholecystectomy compared to those of high-pressure, this method can be replaced by high-pressure in LC.

The Importance of Symptom Validity Testing in Adolescents and Young Adults Undergoing Assessments for Learning or Attention Difficulties

ERIC Educational Resources Information Center

Harrison, Allyson G.; Green, Paul; Flaro, Lloyd

2012-01-01

It is almost self-evident that test results will be unreliable and misleading if those undergoing assessments do not make a full effort on testing. Nevertheless, objective tests of effort have not typically been used with young adults to determine whether test results are valid or not. Because of the potential economic and/or recreational benefits…

Receptor tyrosine kinase inhibitors as potent weapons in war against cancers.

PubMed

Sharma, P Sapra; Sharma, R; Tyagi, T

2009-01-01

Receptor Tyrosine Kinases class I (RTK class I, EGF receptor family) constitute a family of transmembrane proteins involved in various aspects of cell growth and survival and have been implicated in the initiation and progression of several types of human malignancies. Activation of EGFR may be because of overexpression, mutations resulting in constitutive activation, or autocrine expression of ligand. In contrast, activation of HER2 occurs mainly by overexpression, which leads to spontaneous homodimerization and activation of downstream signaling events in a ligand-independent manner. EGFR and HER2 have now been validated as a clinically relevant target, and several different types of agents inhibiting these receptors are currently in development. The EGFR inhibitors Erlotinib, Gefitinib, and Cetuximab have undergone extensive clinical testing and have established clinical activity in non small cell lung cancer (NSCLS) and other types of solid tumors. Several of the other erbB inhibitors are also undergoing advanced clinical testing, either alone or in combination with other agents. This review reports various inhibitors, natural, small molecules and monoclonal antibodies, along with their reported activities for various members of erbB family. It will highlight the potential for the development of novel anti-cancer molecules.

Combined Impact of Chronic Kidney Disease and Contrast Induced Acute Kidney Injury on Long-term Outcomes in Patients with Acute Lower Limb Ischaemia.

PubMed

Zlatanovic, Petar; Koncar, Igor; Dragas, Marko; Ilic, Nikola; Sladojevic, Milos; Mutavdzic, Perica; Tomic, Ivan; Kostic, Dusan; Davidovic, Lazar

2018-07-01

Acute lower limb ischaemia (ALI) is the sudden onset of decreased arterial perfusion with imminent threat to limb viability. Contrast induced acute kidney injury (CI-AKI) is one of the complications that increases mortality in patients who undergo contrast imaging in coronary procedures. The goal of this study is to evaluate the impact of chronic kidney disease (CKD) and CI-AKI on long-term clinical outcomes in patients with ALI undergoing lower limb revascularisation. A total 1017 consecutive patients with acute lower limb ischaemia who were admitted between July 1, 2006, and January 1, 2017, were retrospectively reviewed. Patients who had end stage renal disease, those who had end stage heart and malignant disease and died within 7 days of limb revascularisation, and those who did not undergo angiography were excluded. Thus 546 patients were included in the final analysis. Patients were classified as with or without CKD and were then subdivided according to the presence or absence of the development of CI-AKI, defined as an increase in serum creatinine of ≥0.5 mg/dL or by ≥25% from the baseline value within the first 72 h after contrast exposure. The primary end point was all cause mortality and secondary major adverse limb event (MALE). Both CKD and CI-AKI were associated with the highest rate of all cause mortality (chi square = 55.77, d.f. = 1, p < .01, log rank test) and MALE (chi square = 79.07, d.f. = 1, p < .01, log rank test). The presence of CKD and CI-AKI were significant risk factors associated with long-term all cause mortality (HR = 2.61, p < .01) and MALE (HR = 2.87, p < .01). In patients with ALI undergoing lower limb revascularisation, both CKD and CI-AKI were significantly associated with poor long-term outcomes compared with either CKD or CI-AKI alone. Further studies are required to assess this association and to confirm the combined effect of CKD and CI-AKI on long-term clinical outcomes. Copyright © 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.

Declining prevalence of HIV-1 drug resistance in treatment-failing patients: a clinical cohort study.

PubMed

Di Giambenedetto, Simona; Bracciale, Laura; Colafigli, Manuela; Colatigli, Manuela; Cattani, Paola; Pinnetti, Carmen; Pannetti, Carmen; Bacarelli, Alessandro; Prosperi, Mattia; Fadda, Giovanni; Cauda, Roberto; De Luca, Andrea

2007-01-01

A major barrier to successful viral suppression in HIV type 1 (HIV-1)-infected individuals is the emergence of virus resistant to antiretroviral drugs. We explored the evolution of genotypic drug resistance prevalence in treatment-failing patients from 1999 to 2005 in a clinical cohort. Prevalence of major International AIDS Society-USA HIV-1 drug resistance mutations was measured over calendar years in a population with treatment failure and undergoing resistance testing. Predictors of the presence of resistance mutations were analysed by logistic regression. Significant reductions of the prevalence of resistance to all three drug classes examined were observed. This was accompanied by a reduction in the proportion of treatment-failing patients. Independent predictors of drug resistance were the earlier calendar year, prior use of suboptimal nucleoside analogue therapy, male sex and higher CD4 levels at testing. In a single clinical cohort, we observed a decrease in the prevalence of resistance to all three examined antiretroviral drug classes over time. If this finding is confirmed in multicentre cohorts it may translate into reduced transmission of drug-resistant virus from treated patients.

[Has high-definition spiral computed tomography changed the management of patients with acute pulmonary embolism?].

PubMed

Pesavento, Raffaele; de Conti, Giorgio; Minotto, Isabella; Prandoni, Paolo

2008-12-01

Pulmonary embolism (PE) is a common condition carrying a significant degree of mortality if not diagnosed early. The diagnosis of PE is challenging, because of the non-specific nature of its clinical features. For many years the diagnostic strategies for PE have mainly involved ventilation/perfusion lung scan as the chief diagnostic procedure, often associated with a few clinical models of pre-test probability and the D-dimer test. These modalities of diagnosing PE, though quite satisfactory in various clinical settings, show several limitations, the most important one being the high rate of non-diagnostic procedures. The introduction of computed tomography (CT) has changed the diagnostic strategies and has become the main diagnostic procedure for diagnosing PE. CT is undergoing a rapid technological upgrade, which will open in the near future new frontiers in the diagnosis of PE. Nonetheless, CT carries a number of limitations, which should be carefully identified. This article reviews the evidences on both the traditional and newer diagnostic strategies for PE, outlines their strengths and weaknesses and describes future applications of CT for diagnosing PE.

Patient-reported symptoms and changes up to 1 year after meniscal surgery.

PubMed

Skou, Søren T; Pihl, Kenneth; Nissen, Nis; Jørgensen, Uffe; Thorlund, Jonas Bloch

2018-06-01

Background and purpose - Detailed information on the symptoms and limitations that patients with meniscal tears experience is lacking. This study was undertaken to map the most prevalent self-reported symptoms and functional limitations among patients undergoing arthroscopic meniscal surgery and investigate which symptoms and limitations had improved most at 1 year after surgery. Patients and methods - Patients aged 18-76 years from the Knee Arthroscopy Cohort Southern Denmark (KACS) undergoing arthroscopic meniscal surgery were included in this analysis of individual subscale items from the Knee Injury and Osteoarthritis Outcome Score and 1 question on knee stability. Severity of each item was scored as none, mild, moderate, severe, or extreme. Improvements were evaluated using Wilcoxon's signed-rank test and effect size (ES). Results - The most common symptoms were knee grinding and clicking, knee pain in general, pain when twisting and bending the knee and climbing stairs (88-98%), while the most common functional limitations were difficulty bending to the floor, squatting, twisting, kneeling, and knee awareness (97-99%). Knee pain in general and knee awareness improved most 1 year after meniscal surgery (ES -0.47 and -0.45; p < 0.001), while knee instability and general knee difficulties improved least (ES 0.10 and -0.08; p < 0.006). Interpretation - Adults undergoing surgery for a meniscal tear commonly report clinical symptoms and functional limitations related to their daily activities. Moderate improvements were observed in some symptoms and functional limitations and small to no improvement in others at 1 year after surgery. These findings can assist the clinical discussion of symptoms, treatments, and patients' expectations.

Relationship between pre-extubation positive endexpiratory pressure and oxygenation after coronary artery bypass grafting

PubMed Central

Lima, Reijane Oliveira; Borges, Daniel Lago; Costa, Marina de Albuquerque Gonçalves; Baldez, Thiago Eduardo Pereira; Silva, Mayara Gabrielle Barbosa e; Sousa, Felipe André Silva; Soares, Milena de Oliveira; Pinto, Jivago Gentil Moreira

2015-01-01

Introduction After removal of endotracheal tube and artificial ventilation, ventilatory support should be continued, offering oxygen supply to ensure an arterial oxygen saturation close to physiological. Objective The aim of this study was to investigate the effects of positive-end expiratory pressure before extubation on the oxygenation indices of patients undergoing coronary artery bypass grafting. Methods A randomized clinical trial with seventy-eight patients undergoing coronary artery bypass grafting divided into three groups and ventilated with different positive-end expiratory pressure levels prior to extubation: Group A, 5 cmH2O (n=32); Group B, 8 cmH2O (n=26); and Group C, 10 cmH2O (n=20). Oxygenation index data were obtained from arterial blood gas samples collected at 1, 3, and 6 h after extubation. Patients with chronic pulmonary disease and those who underwent off-pump, emergency, or combined surgeries were excluded. For statistical analysis, we used Shapiro-Wilk, G, Kruskal-Wallis, and analysis of variance tests and set the level of significance at P<0.05. Results Groups were homogenous with regard to demographic, clinical, and surgical variables. There were no statistically significant differences between groups in the first 6 h after extubation with regard to oxygenation indices and oxygen therapy utilization. Conclusion In this sample of patients undergoing coronary artery bypass grafting, the use of different positive-end expiratory pressure levels before extubation did not affect gas exchange or oxygen therapy utilization in the first 6 h after endotracheal tube removal. PMID:27163418

The impact of failing to identify suspect effort in patients undergoing adult attention-deficit/hyperactivity disorder (ADHD) assessment.

PubMed

Marshall, Paul S; Hoelzle, James B; Heyerdahl, Danielle; Nelson, Nathaniel W

2016-10-01

[Correction Notice: An Erratum for this article was reported in Vol 28(10) of Psychological Assessment (see record 2016-22725-001). In the article, the penultimate sentence of the abstract should read “These results suggest that a significant percentage of those making a suspect effort will be diagnosed with ADHD using the most commonly employed assessment methods: an interview alone (71%); an interview and ADHD behavior rating scales combined (65%); and an interview, behavior rating scales, and most continuous performance tests combined (62%).” All versions of this article have been corrected.] This retrospective study examines how many adult patients would plausibly receive a diagnosis of attention-deficit/hyperactivity disorder (ADHD) if performance and symptom validity measures were not administered during neuropsychological evaluations. Five hundred fifty-four patients were extracted from an archival clinical dataset. A total of 102 were diagnosed with ADHD based on cognitive testing, behavior rating scales, effort testing, and clinical interview; 115 were identified as putting forth suspect effort in accordance with the Slick, Sherman, and Iverson (1999) criteria. From a clinical decision-making perspective, suspect effort and ADHD groups were nearly indistinguishable on ADHD behavior, executive function, and functional impairment rating scales, as well as on cognitive testing and key clinical interview questions. These results suggest that a significant percentage of those making a suspect effort will be diagnosed with ADHD using the most commonly employed assessment methods: an interview alone (71%); an interview and ADHD behavior rating scales combined (65%); and an interview, behavior rating scales, and most continuous performance tests combined (62%) [corrected]. This research makes clear that it is essential to evaluate task engagement and possible symptom amplification during clinical evaluations. PsycINFO Database Record (c) 2016 APA, all rights reserved

Hypersensitivity reactions to metal implants: laboratory options.

PubMed

Carossino, Anna Maria; Carulli, Christian; Ciuffi, Simone; Carossino, Roberto; Zappoli Thyrion, Giorgia Donata; Zonefrati, Roberto; Innocenti, Massimo; Brandi, Maria Luisa

2016-11-23

All implant compounds undergo an electrochemical process when in contact with biological fluids, as well as mechanical corrosion due to abrasive wear, with production of metal debris that may inhibit repair processes. None of the commonly-used methods can diagnose implant allergies when used singly, therefore a panel of tests should be performed on allergic patients as pre-operative screening, or when a postoperative metal sensitisation is suspected. We analysed patients with painful prostheses and subjects prone to allergies using the Patch Test in comparison with the Lymphocyte Transformation Test. Cytokine production was evaluated to identify prognostic markers for early diagnosis of aseptic loosening. Metal debris endocytosis and cytoskeletal rearrangement was visualised by confocal microscopy. Our results demonstrate that the Lymphocyte Transformation Test can identify patients who have a predisposition to develop allergic reactions and can confirm the diagnosis of hypersensitivity in patients with painful prostheses. The prevalence of a Th2-cytokine pattern may be used to identify predisposition to the development of allergic diseases, while the selective presence of osteoclastogenic cytokines may be used as predictor of a negative outcome in patients with painful prosthesis. The hypothesis of the prognostic value of these cytokines as early markers of aseptic loosening is attractive, but its confirmation would require extensive testing. The Lymphocyte Transformation Test is the most suitable method for testing systemic allergies. We suggest that the combined use of the Patch Test and the Lymphocyte Transformation Test, associated with cytokine detection in selected patients, could provide a useful tool for preventive evaluation of immune reactivity in patients undergoing primary joint replacement surgery, and for clinical monitoring of the possible onset of a metal sensitization in patients with implanted devices.

Predicted versus observed 30-day perioperative outcomes using the ACS NSQIP surgical risk calculator in patients undergoing partial nephrectomy for renal cell carcinoma.

PubMed

Blair, Brian M; Lehman, Erik B; Jafri, Syed M; Kaag, Matthew G; Raman, Jay D

2018-06-04

The purpose of the study was to evaluate the accuracy of the American College of Surgeons NSQIP Surgical Risk Calculator for predicting risk-adjusted 30-day outcomes for patients undergoing partial nephrectomy (PN) for renal cell carcinoma (RCC). A single institution, multi-surgeon, prospectively maintained database was queried for patients undergoing PN for RCC from 1998 to 2015. 21 preoperative factors were analyzed for each patient with predicted risk for 30-day complications, mortality, and length of stay (LOS) calculated. Differences between the mean predicted risk and observed rate of surgical outcomes were determined using two-sided one-sample t test with significance at p < 0.05. Subgroup analyses of outcomes stratified by surgical approach were also performed. 470 patients undergoing PN for RCC were analyzed. Comparing NSQIP predicted to observed outcomes, clinically significant underestimations occurred with rates of overall complications (9.16 vs. 16.81%, p < 0.001), surgical site infections [SSI] (1.65 vs. 2.77%, p < 0.001), urinary tract infection [UTI] (1.41 vs. 3.40%, p < 0.001), and LOS (3.25 vs. 3.73 days, p < 0.001). On subgroup analysis, 209 open PN and 261 minimally invasive PN (MIPN) were performed. The NSQIP calculator consistently underestimated overall complications, SSI, UTI, and LOS (p < 0.001) among both surgical approaches, while overestimating MIPN severe complications (p < 0.001). Clinically important differences persisted when stratifying the MIPN group by laparoscopic (N = 111) and robotic (N = 150) approaches. The ACS NSQIP Surgical Risk Calculator had significant discrepancies among observed and predicted outcomes. Additional analyses confirmed these differences remained significant irrespective of surgical approach. These findings emphasize the need for urologic oncology-specific calculators to better predict surgical outcomes in this complex patient population.

Coronary Computed Tomography Angiography vs Functional Stress Testing for Patients With Suspected Coronary Artery Disease: A Systematic Review and Meta-analysis.

PubMed

Foy, Andrew J; Dhruva, Sanket S; Peterson, Brandon; Mandrola, John M; Morgan, Daniel J; Redberg, Rita F

2017-11-01

Coronary computed tomography angiography (CCTA) is a new approach for the diagnosis of anatomical coronary artery disease (CAD), but it is unclear how CCTA performs compared with the standard approach of functional stress testing. To compare the clinical effectiveness of CCTA with that of functional stress testing for patients with suspected CAD. A systematic literature search was conducted in PubMed and MEDLINE for English-language randomized clinical trials of CCTA published from January 1, 2000, to July 10, 2016. Researchers selected randomized clinical trials that compared a primary strategy of CCTA with that of functional stress testing for patients with suspected CAD and reported data on patient clinical events and changes in therapy. Two reviewers independently extracted data from and assessed the quality of the trials. This analysis followed the PRISMA statement for reporting systematic reviews and meta-analyses and used the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. The Mantel-Haenszel method was used to conduct the primary analysis. Summary relative risks were calculated with a random-effects model. The outcomes of interest were all-cause mortality, cardiac hospitalization, myocardial infarction, invasive coronary angiography, coronary revascularization, new CAD diagnoses, and change in prescription for aspirin and statins. Thirteen trials were included, with 10 315 patients in the CCTA arm and 9777 patients in the functional stress testing arm who were followed up for a mean duration of 18 months. There were no statistically significant differences between CCTA and functional stress testing in death (1.0% vs 1.1%; risk ratio [RR], 0.93; 95% CI, 0.71-1.21) or cardiac hospitalization (2.7% vs 2.7%; RR, 0.98; 95% CI, 0.79-1.21), but CCTA was associated with a reduction in the incidence of myocardial infarction (0.7% vs 1.1%; RR, 0.71; 95% CI, 0.53-0.96). Patients undergoing CCTA were significantly more likely to undergo invasive coronary angiography (11.7% vs 9.1%; RR, 1.33; 95% CI, 1.12-1.59) and revascularization (7.2% vs 4.5%; RR, 1.86; 95% CI, 1.43-2.43). They were also more likely to receive a diagnosis of new CAD and to have initiated aspirin or statin therapy. Compared with functional stress testing, CCTA is associated with a reduced incidence of myocardial infarction but an increased incidence of invasive coronary angiography, revascularization, CAD diagnoses, and new prescriptions for aspirin and statins. Despite these differences, CCTA is not associated with a reduction in mortality or cardiac hospitalizations.

Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery.

PubMed

Voineskos, Sophocles H; Nelson, Jonas A; Klassen, Anne F; Pusic, Andrea L

2018-01-29

Satisfaction and improved quality of life are among the most important outcomes for patients undergoing plastic and reconstructive surgery for a variety of diseases and conditions. Patient-reported outcome measures (PROMs) are essential tools for evaluating the benefits of newly developed surgical techniques. Modern PROMs are being developed with new psychometric approaches, such as Rasch Measurement Theory, and their measurement properties (validity, reliability, responsiveness) are rigorously tested. These advances have resulted in the availability of PROMs that provide clinically meaningful data and effectively measure functional as well as psychosocial outcomes. This article guides the reader through the steps of creating a PROM and highlights the potential research and clinical uses of such instruments. Limitations of PROMs and anticipated future directions in this field are discussed.

Heparin-Induced Thrombocytopenia with Associated Thrombosis in Children after the Fontan Operation

PubMed Central

Porcelli, Rosalia; Moskowitz, Bonnie C.; Cetta, Frank; Graham, Lynn C.; Godwin, John E.; Eidem, Benjamin W.; Prechel, M. Margaret; Walenga, Jeanine M.

2003-01-01

Heparin-induced thrombocytopenia is a widely recognized clinical disorder. The spectrum of disease ranges from clinically insignificant to severe thrombosis (heparin-induced thrombocytopenia with associated thrombosis). Overall, thrombosis occurs in approximately 33% of adults diagnosed with heparin-induced thrombocytopenia and has been associated with high morbidity and mortality rates. Diagnostic testing for this disorder is not standard in children with thrombocytopenia who are receiving heparin, despite the fact that children with congenital heart disease may be exposed to heparin frequently. There are few reported cases of heparin-induced thrombocytopenia with associated thrombosis in children; herein, we describe the cases of 2 children who developed this disorder after undergoing a Fontan operation. (Tex Heart Inst J 2003;30:58–61) PMID:12638673

Recurrent Obstructive Giant Inflammatory Polyposis of the Colon

PubMed Central

Budhraja, Vikram

2016-01-01

Inflammatory polyps are relatively common in patients with inflammatory bowel disease. The term giant inflammatory polyposis is used to describe inflammatory polyps greater than 1.5 cm in any dimension. Their clinical presentation can be varied, ranging from asymptomatic, with incidental detection on radiological or endoscopic testing, to symptomatic, with rectal bleeding and colonic obstruction. Although giant inflammatory polyposis is a rare finding, it is of clinical importance, since it is easily mistaken for colon cancer, with patients sometimes undergoing radical surgeries. We describe an unusual case of giant inflammatory polyposis causing recurrent symptomatic obstruction despite multiple segmental colectomies in a patient with indeterminate colitis. This is the first such reported case in English literature to the best of our knowledge. PMID:27807551

Recurrent Obstructive Giant Inflammatory Polyposis of the Colon.

PubMed

Syal, Gaurav; Budhraja, Vikram

2016-08-01

Inflammatory polyps are relatively common in patients with inflammatory bowel disease. The term giant inflammatory polyposis is used to describe inflammatory polyps greater than 1.5 cm in any dimension. Their clinical presentation can be varied, ranging from asymptomatic, with incidental detection on radiological or endoscopic testing, to symptomatic, with rectal bleeding and colonic obstruction. Although giant inflammatory polyposis is a rare finding, it is of clinical importance, since it is easily mistaken for colon cancer, with patients sometimes undergoing radical surgeries. We describe an unusual case of giant inflammatory polyposis causing recurrent symptomatic obstruction despite multiple segmental colectomies in a patient with indeterminate colitis. This is the first such reported case in English literature to the best of our knowledge.

Use and Yield of Baseline Imaging and Laboratory Testing in Stage II Breast Cancer

PubMed Central

Guo, Hao; Sutton, Jazmine; Spring, Laura; Faig, Jennifer; Dagogo-Jack, Ibiayi; Battelli, Chiara; Houlihan, Mary Jane; Yeh, Tsai-Chu; Come, Steven E.; Lin, Nancy U.

2016-01-01

Background. Despite guideline recommendations, baseline laboratory testing and advanced imaging are widely ordered in clinical practice to stage asymptomatic patients with clinical stage II breast cancer (BC). Materials and Methods. A retrospective study at two academic centers in Boston, Massachusetts, between 2006 and 2007 explored the use, results, and implications of laboratory tests, tumor markers, and imaging in patients with clinical stage II BC. Results. Among 411 patients, 233 (57%) had liver function testing, 134 (33%) had tumor marker tests, and 237 (58%) had computed tomography (CT) as part of their initial diagnostic workup. Median age was 52 (range, 23–90 years). On multivariable analysis, young age, more advanced stage, and tumor subtype (human epidermal growth receptor-positive [HER2+] and triple-negative breast cancer [TNBC]) were significantly associated with baseline CT. The rate of detection of true metastatic disease with use of baseline staging imaging was 2.1% (95% confidence interval, 0.7%–5%). It was 2.2% (3 of 135) for estrogen receptor/progesterone receptor-positive disease, 1.9% (1 of 54) for HER2+ disease, and 2.1% (1 of 48) for TNBC. At 5 years of follow-up, 46 of 406 patients were diagnosed with metastatic breast cancer. Thirty-four of 46 (73.9%) who developed recurrent disease had imaging at their initial diagnosis, and of these, five had abnormalities on their initial imaging that was correlated with where they developed metastatic disease. Conclusion. In this cohort of women with stage II BC, staging imaging at diagnosis had a low yield in detecting distant metastases (2.1%). The detection rate was not higher with HER2+ disease or TNBC, despite the trend that patients with these subtypes were more likely to undergo imaging. Implications for Practice: Despite guideline recommendations, asymptomatic patients with stage II breast cancer (BC) often undergo staging imaging with computed tomography, bone scanning, or positron emission tomography. Physicians have often reported that they order imaging despite recommendations because they believe that younger patients or patients with more aggressive BC phenotypes, such as human epidermal receptor 2-positive BC or triple-negative BC, benefit from staging imaging. In this cohort of women younger than those in prior studies, the yield of detecting distant metastatic disease in patients with clinical stage II BC was very low and the detection rate was not higher in the presence of HER2-positive or triple-negative BC. PMID:27551013

Is a combination of Tc-SPECT or perfusion weighted magnetic resonance imaging with spinal tap test helpful in the diagnosis of normal pressure hydrocephalus?

PubMed

Hertel, F; Walter, C; Schmitt, M; Mörsdorf, M; Jammers, W; Busch, H P; Bettag, M

2003-04-01

The aim of this study was to evaluate the combination of spinal tap test (STT) with cerebral perfusion measurement assessed either by Tc-bicisate-SPECT (Tc-SPECT) or perfusion weighted MRI (pwMRI), or both, for a better preoperative selection of promising candidates for shunt operations in suspected idiopathic normal pressure hydrocephalus. 27 consecutive patients were examined with a standard clinical protocol (assessed by the Homburg Hydrocephalus Scale (HHS)) as well as with 99m Tc-bicisate-SPECT (n=27) or additionally by pwMRI (n=12) before and after STT. The results of these examinations were compared preoperatively for each patient and correlated with postoperative clinical outcome after shunt surgery. Nine patients showed both, a clinical improvement, and increased cerebral perfusion after STT. They underwent shunt surgery with good to excellent results. In another nine patients increasing cerebral perfusion was detected although they did not show a clear clinical improvement after STT. Six of them also received a shunt operation with good to excellent outcome. Three patients of the last group could have an operation. Nine patients did not show any clinical improvement or any kind of increasing cerebral perfusion after STT. Therefore, they did not undergo surgery. The results of SPECT and pwMRI correlated in 92 % of the patients (11 of 12). It is concluded that a combination of clinical assessment with SPECT or pwMRI is helpful in the preoperative selection of patients for shunting procedures with suspected NPH syndrome. This combination is a minimal invasive and objective test modality that is superior to STT alone. Further studies are necessary for a comparison of the described imaging techniques with different diagnostic tests in this difficult field of cerebral disease.

Surrounded by work platforms, the full-scale Orion AFT crew module (center) is undergoing preparations for the first flight test of Orion's launch abort system.

NASA Image and Video Library

2008-05-20

Surrounded by work platforms, NASA's first full-scale Orion abort flight test (AFT) crew module (center) is undergoing preparations at the NASA Dryden Flight Research Center in California for the first flight test of Orion's launch abort system.

Antares alignment gimbal positioner linear bearing tests

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

Day, R.D.; McKay, M.D.; Pierce, D.D.

1981-01-01

The data indicate that of the six configurations tested, the solid circular rails with either the wet or dry lubricant are superior to the other configurations. Therefore, these two will undergo additional tests. These tests will consist of (1) modifying the testing procedure to obtain a better estimation of the limits of precision; and (2) subjecting the bearings to moments more closely approximating the actual conditions they will undergo on the AGP.

A rare case of watermelon stomach in woman with continuous ambulatory peritoneal dialysis and systemic lupus erythematosus.

PubMed

Jinga, Mariana; Checheriţă, I A; Becheanu, G; Jinga, V; Peride, Ileana; Niculae, A

2013-01-01

We report a case of a 42-year-old woman with systemic lupus erythematosus and chronic kidney disease stage 5 undergoing continuous ambulatory peritoneal dialysis, presenting asthenia, dizziness, abdominal pain and small efforts dyspnea. After a complete physical and clinical examination, including laboratory tests, esophagogastroduodenal endoscopy and gastric lesions biopsy, she was diagnosed with gastric antral vascular ectasia. We are facing a rare case of antral vascular ectasia in a patient associating both chronic kidney disease and autoimmune disease.

The economic implications of a multimodal analgesic regimen for patients undergoing major orthopedic surgery: a comparative study of direct costs.

PubMed

Duncan, Christopher M; Hall Long, Kirsten; Warner, David O; Hebl, James R

2009-01-01

Total knee and total hip arthoplasty (THA) are 2 of the most common surgical procedures performed in the United States and represent the greatest single Medicare procedural expenditure. This study was designed to evaluate the economic impact of implementing a multimodal analgesic regimen (Total Joint Regional Anesthesia [TJRA] Clinical Pathway) on the estimated direct medical costs of patients undergoing lower extremity joint replacement surgery. An economic cost comparison was performed on Mayo Clinic patients (n = 100) undergoing traditional total knee or total hip arthroplasty using the TJRA Clinical Pathway. Study patients were matched 1:1 with historical controls undergoing similar procedures using traditional anesthetic (non-TJRA) techniques. Matching criteria included age, sex, surgeon, type of procedure, and American Society of Anesthesiologists (ASA) physical status (PS) classification. Hospital-based direct costs were collected for each patient and analyzed in standardized inflation-adjusted constant dollars using cost-to-charge ratios, wage indexes, and physician services valued using Medicare reimbursement rates. The estimated mean direct hospital costs were compared between groups, and a subgroup analysis was performed based on ASA PS classification. The estimated mean direct hospital costs were significantly reduced among TJRA patients when compared with controls (cost difference, 1999 dollars; 95% confidence interval, 584-3231 dollars; P = 0.0004). A significant reduction in hospital-based (Medicare Part A) costs accounted for the majority of the total cost savings. Use of a comprehensive, multimodal analgesic regimen (TJRA Clinical Pathway) in patients undergoing lower extremity joint replacement surgery provides a significant reduction in the estimated total direct medical costs. The reduction in mean cost is primarily associated with lower hospital-based (Medicare Part A) costs, with the greatest overall cost difference appearing among patients with significant comorbidities (ASA PS III-IV patients).

Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events.

PubMed

Augestad, Knut M; Vonen, Barthold; Aspevik, Ranveig; Nestvold, Torunn; Ringberg, Unni; Johnsen, Roar; Norum, Jan; Lindsetmo, Rolv-Ole

2008-06-25

All patients who undergo surgery for colon cancer are followed up according to the guidelines of the Norwegian Gastrointestinal Cancer Group (NGICG). These guidelines state that the aims of follow-up after surgery are to perform quality assessment, provide support and improve survival. In Norway, most of these patients are followed up in a hospital setting. We describe a multi-centre randomized controlled trial to test whether these patients can be followed up by their general practitioner (GP) without altering quality of life, cost effectiveness and/or the incidence of serious clinical events. Patients undergoing surgery for colon cancer with histological grade Dukes's Stage A, B or C and below 75 years of age are eligible for inclusion. They will be randomized after surgery to follow-up at the surgical outpatient clinic (control group) or follow-up by the district GP (intervention group). Both study arms comply with the national NGICG guidelines. The primary endpoints will be quality of life (QoL) (measured by the EORTC QLQ C-30 and the EQ-5D instruments), serious clinical events (SCEs), and costs. The follow-up period will be two years after surgery, and quality of life will be measured every three months. SCEs and costs will be estimated prospectively. The sample size was 170 patients. There is an ongoing debate on the best method of follow-up for patients with CRC. Due to a wide range of follow-up programmes and paucity of randomized trials, it is impossible to draw conclusions about the best combination and frequency of clinic (or family practice) visits, blood tests, endoscopic procedures and radiological examinations that maximize the clinical outcome, quality of life and costs. Most studies on follow-up of CRC patients have been performed in a hospital outpatient setting. We hypothesize that postoperative follow-up of colon cancer patients (according to national guidelines) by GPs will not have any impact on patients' quality of life. Furthermore, we hypothesize that there will be no increase in SCEs and that the incremental cost-effectiveness ratio will improve. This trial has been registered at ClinicalTrials.gov. The trial registration number is: NCT00572143.

Discordant CSF/plasma HIV-1 RNA in patients with unexplained low-level viraemia.

PubMed

Nightingale, Sam; Geretti, Anna Maria; Beloukas, Apostolos; Fisher, Martin; Winston, Alan; Else, Laura; Nelson, Mark; Taylor, Stephen; Ustianowski, Andrew; Ainsworth, Jonathan; Gilson, Richard; Haddow, Lewis; Ong, Edmund; Watson, Victoria; Leen, Clifford; Minton, Jane; Post, Frank; Pirmohamed, Munir; Solomon, Tom; Khoo, Saye

2016-12-01

The central nervous system has been proposed as a sanctuary site where HIV can escape antiretroviral control and develop drug resistance. HIV-1 RNA can be at higher levels in CSF than plasma, termed CSF/plasma discordance. We aimed to examine whether discordance in CSF is associated with low level viraemia (LLV) in blood. In this MRC-funded multicentre study, we prospectively recruited patients with LLV, defined as one or more episode of unexplained plasma HIV-1 RNA within 12 months, and undertook CSF examination. Separately, we prospectively collected CSF from patients undergoing lumbar puncture for a clinical indication. Patients with durable suppression of viraemia and no evidence of CNS infection were identified as controls from this group. Factors associated with CSF/plasma HIV-1 discordance overall were examined. One hundred fifty-three patients were recruited across 13 sites; 40 with LLV and 113 undergoing clinical lumbar puncture. Seven of the 40 (18 %) patients with LLV had CSF/plasma discordance, which was significantly more than 0/43 (0 %) with durable suppression in blood from the clinical group (p = 0.005). Resistance associated mutations were shown in six CSF samples from discordant patients with LLV (one had insufficient sample for testing), which affected antiretroviral therapy at sampling in five. Overall discordance was present in 20/153 (13 %) and was associated with nadir CD4 but not antiretroviral concentrations in plasma or CSF. CSF/plasma discordance is observed in patients with LLV and is associated with antiretroviral resistance associated mutations in CSF. The implications for clinical practice require further investigation.

Chronic obstructive pulmonary disease exacerbation in the intensive care unit: clinical, functional and quality of life at discharge and 3 months of follow up.

PubMed

Viana, Renata Cristina Teixeira Pinto; Pincelli, Mariangela Pimentel; Pizzichini, Emílio; Silva, André Pacheco; Manes, Joice; Marconi, Tatiana Dias; Steidle, Leila John Marques

2017-01-01

The purpose of this study was to evaluate the clinical/functional aspects and quality of life of chronic obstructive pulmonary disease patients who were discharged after an intensive care unit admission for acute respiratory failure. This prospective study included chronic obstructive pulmonary disease patients who were admitted to two intensive care units between December of 2010 and August of 2011 and evaluated over three visits after discharge. Thirty patients were included, and 20 patients completed the three-month follow up. There was a significant improvement in the following: forced expiratory flow in one second (L) (1.1/1.4/1.4; p = 0.019), six-minute walk test (m) (- /232.8 /272.6; p = 0.04), BODE score (7.5/5.0/3.8; p = 0.001), cognition measured by the Mini Mental State Examination (21/23.5/23.5; p = 0.008) and quality of life measured by the total Saint George Respiratory Questionnaire score (63.3/56.8/51, p = 0.02). The mean difference in the total score was 12.3 (between visits 1 and three). Important clinical differences were observed for the symptom score (18.8), activities score (5.2) and impact score (14.3). The majority of participants (80%) reported they would be willing to undergo a new intensive care unit admission. Despite the disease severity, there was a significant clinical, functional and quality of life improvement at the end of the third month. Most patients would be willing to undergo a new intensive care unit admission.

Associations of common variants at ALDH2 gene and the risk of stroke in patients with coronary artery diseases undergoing percutaneous coronary intervention.

PubMed

You, Ling; Li, Chenze; Zhao, Jinzhao; Wang, Dao Wen; Cui, Wei

2018-05-01

Limited data are available about the role of common variants at the aldehyde dehydrogenase 2 gene (ALDH2) on the clinical outcome in Chinese patients with coronary heart disease (CHD) undergoing percutaneous coronary intervention (PCI). In the present study, a total of 1089 patients were consecutively enrolled from January 2012 and July 2013. Six common variants at ALDH2 gene, including rs2339840, rs4648328, rs4767939, rs11066028, rs16941669, and rs671, were selected to test the associations of those polymorphisms with the cardiovascular outcome in patients with CHD after PCI. The clinical endpoints included cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. The composite of clinical endpoints was defined as the primary endpoint, and every endpoint alone was considered as the secondary endpoints. The median follow-up time was 38.27 months. Our results showed that the common variant rs2339840 was independently associated with a lower risk of stroke in patients with CHD after PCI (codominant model, HR = 0.32, 95% CI, 0.11-0.91, P = .074 for heterozygotes; HR = 0.25, 95% CI, 0.06-1.14, P = .033 for homozygotes; dominant model, HR = 0.32, 95% CI, 0.14-0.74, P = .007). However, no significant associations were found between other 5 single nucleotide polymorphisms (SNPs) and the clinical endpoints. For the first time, the common variant rs2339840 was reported to be a protective factor against stroke in CHD patients with PCI.

Animal-Assisted Therapy for Patients Undergoing Treatment at NIH Clinical Center | NIH MedlinePlus the Magazine

MedlinePlus

... this page please turn JavaScript on. Feature: Therapy Dogs Animal-Assisted Therapy for Patients Undergoing Treatment at ... Kerry (middle), a patient, is with the therapy dog team of Jeanette Golden (left) and Tucker the ...

Revised ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management. Implications for preoperative clinical evaluation.

PubMed

Guarracino, F; Baldassarri, R; Priebe, H J

2015-02-01

Each year, an increasing number of elderly patients with cardiovascular disease undergoing non-cardiac surgery require careful perioperative management to minimize the perioperative risk. Perioperative cardiovascular complications are the strongest predictors of morbidity and mortality after major non-cardiac surgery. A Joint Task Force of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA) has recently published revised Guidelines on the perioperative cardiovascular management of patients scheduled to undergo non-cardiac surgery, which represent the official position of the ESC and ESA on various aspects of perioperative cardiac care. According to the Guidelines effective perioperative cardiac management includes preoperative risk stratification based on preoperative assessment of functional capacity, type of surgery, cardiac risk factors, and cardiovascular function. The ESC/ESA Guidelines discourage indiscriminate routine preoperative cardiac testing, because it is time- and cost-consuming, resource-limiting, and does not improve perioperative outcome. They rather emphasize the importance of individualized preoperative cardiac evaluation and the cooperation between anesthesiologists and cardiologists. We summarize the relevant changes of the 2014 Guidelines as compared to the previous ones, with particular emphasis on preoperative cardiac testing.

Effect of Incentive Spirometry on Postoperative Hypoxemia and Pulmonary Complications After Bariatric Surgery: A Randomized Clinical Trial.

PubMed

Pantel, Haddon; Hwang, John; Brams, David; Schnelldorfer, Thomas; Nepomnayshy, Dmitry

2017-05-01

The combination of obesity and foregut surgery puts patients undergoing bariatric surgery at high risk for postoperative pulmonary complications. Postoperative incentive spirometry (IS) is a ubiquitous practice; however, little evidence exists on its effectiveness. To determine the effect of postoperative IS on hypoxemia, arterial oxygen saturation (Sao2) level, and pulmonary complications after bariatric surgery. A randomized noninferiority clinical trial enrolled patients undergoing bariatric surgery from May 1, 2015, to June 30, 2016. Patients were randomized to postoperative IS (control group) or clinical observation (test group) at a single-center tertiary referral teaching hospital. Analysis was based on the evaluable population. The controls received the standard of care with IS use 10 times every hour while awake. The test group did not receive an IS device or these orders. The primary outcome was frequency of hypoxemia, defined as an Sao2 level of less than 92% without supplementation at 6, 12, and 24 postoperative hours. Secondary outcomes were Sao2 levels at these times and the rate of 30-day postoperative pulmonary complications. A total of 224 patients (50 men [22.3%] and 174 women [77.7%]; mean [SD] age, 45.6 [11.8] years) were enrolled, and 112 were randomized for each group. Baseline characteristics of the groups were similar. No significant differences in frequency of postoperative hypoxemia between the control and test groups were found at 6 (11.9% vs 10.4%; P = .72), 12 (5.4% vs 8.2%; P = .40), or 24 (3.7% vs 4.6%; P = .73) postoperative hours. No significant differences were observed in mean (SD) Sao2 level between the control and test groups at 6 (94.9% [3.2%] vs 94.9% [2.9%]; P = .99), 12 (95.4% [2.2%] vs 95.1% [2.5%]; P = .40), or 24 (95.7% [2.4%] vs 95.6% [2.4%]; P = .69) postoperative hours. Rates of 30-day postoperative pulmonary complications did not differ between groups (8 patients [7.1%] in the control group vs 4 [3.6%] in the test group; P = .24). Postoperative IS did not demonstrate any effect on postoperative hypoxemia, Sao2 level, or postoperative pulmonary complications. Based on these findings, the routine use of IS is not recommended after bariatric surgery in its current implementation. clinicaltrials.gov Identifier: NCT02431455.

NASA Dryden's F-15B aircraft with the Gulfstream Quiet Spike sonic boom mitigator attached undergoes ground vibration testing in preparation for test flights

NASA Image and Video Library

2006-05-01

NASA Dryden's F-15B testbed aircraft with the Gulfstream Quiet Spike sonic boom mitigator attached undergoes ground vibration testing in preparation for test flights. The project seeks to verify the structural integrity of the multi-segmented, articulating spike attachment designed to reduce and control a sonic boom.

Data-driven approach for assessing utility of medical tests using electronic medical records.

PubMed

Skrøvseth, Stein Olav; Augestad, Knut Magne; Ebadollahi, Shahram

2015-02-01

To precisely define the utility of tests in a clinical pathway through data-driven analysis of the electronic medical record (EMR). The information content was defined in terms of the entropy of the expected value of the test related to a given outcome. A kernel density classifier was used to estimate the necessary distributions. To validate the method, we used data from the EMR of the gastrointestinal department at a university hospital. Blood tests from patients undergoing surgery for gastrointestinal surgery were analyzed with respect to second surgery within 30 days of the index surgery. The information content is clearly reflected in the patient pathway for certain combinations of tests and outcomes. C-reactive protein tests coupled to anastomosis leakage, a severe complication show a clear pattern of information gain through the patient trajectory, where the greatest gain from the test is 3-4 days post index surgery. We have defined the information content in a data-driven and information theoretic way such that the utility of a test can be precisely defined. The results reflect clinical knowledge. In the case we used the tests carry little negative impact. The general approach can be expanded to cases that carry a substantial negative impact, such as in certain radiological techniques. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Risk-adjusted sequential probability ratio tests: applications to Bristol, Shipman and adult cardiac surgery.

PubMed

Spiegelhalter, David; Grigg, Olivia; Kinsman, Robin; Treasure, Tom

2003-02-01

To investigate the use of the risk-adjusted sequential probability ratio test in monitoring the cumulative occurrence of adverse clinical outcomes. Retrospective analysis of three longitudinal datasets. Patients aged 65 years and over under the care of Harold Shipman between 1979 and 1997, patients under 1 year of age undergoing paediatric heart surgery in Bristol Royal Infirmary between 1984 and 1995, adult patients receiving cardiac surgery from a team of cardiac surgeons in London,UK. Annual and 30-day mortality rates. Using reasonable boundaries, the procedure could have indicated an 'alarm' in Bristol after publication of the 1991 Cardiac Surgical Register, and in 1985 or 1997 for Harold Shipman depending on the data source and the comparator. The cardiac surgeons showed no significant deviation from expected performance. The risk-adjusted sequential probability test is simple to implement, can be applied in a variety of contexts, and might have been useful to detect specific instances of past divergent performance. The use of this and related techniques deserves further attention in the context of prospectively monitoring adverse clinical outcomes.

Effects of testosterone supplementation on clinical and rehabilitative outcomes in older men undergoing on-pump CABG.

PubMed

Maggio, Marcello; Nicolini, Francesco; Cattabiani, Chiara; Beghi, Cesare; Gherli, Tiziano; Schwartz, Robert S; Valenti, Giorgio; Ceda, Gian Paolo

2012-07-01

Testosterone levels decrease with age. This decline is steeper during "critical illnesses". Cardiac surgery is a particular representative model of major clinical condition producing stress responses similar to those observed during severe nonsurgical illness. Cardiac revascularization with extracorporeal circulation is characterized by marked postoperative complications such as insulin resistance, a pro-inflammatory state, acute anemia and renal dysfunction. These phenomena are more evident in older subjects, who are particularly vulnerable in the post-operative state, a condition that has been recently termed as "acute postoperative frailty". We recently showed that in older men with low ejection fraction undergoing cardiac revascularization with extracorporeal circulation, there is a profound decline in anabolic hormones, including testosterone. After surgery testosterone concentration frequently declines to less than 200 ng/dl, a situation suggestive of overt hypogonadism. Since men with low testosterone levels have a high probability of developing mobility limitations, we considered this a rationale for the perioperative use of testosterone treatment in older men undergoing cardiac revasularization surgery. We hypothesized that testosterone supplementation at this time might attenuate the impressive post-surgical catabolic hormonal milieu. The aim of this manuscript is to elucidate an ongoing randomized clinical trial in older men (70+ years old) undergoing elective cardiovascular revascularization with extracorporeal circulation. This randomized clinical trial will evaluate the effects of intramuscular testosterone administration on clinical and functional outcomes in this population. The study will also address potential mechanisms underlying the expected beneficial effects of testosterone supplementation including improvement of insulin sensitivity, markers of inflammatory status and improved hemoglobin levels. Copyright © 2012 Elsevier Inc. All rights reserved.

Using a pulse oximeter to determine clinical depth of anesthesia-investigation of the utility of the perfusion index.

PubMed

Krishnamohan, Anirudh; Siriwardana, Viraj; Skowno, Justin J

2016-11-01

Peripheral vasodilation is a well-recognized side effect of general anesthesia, and induces changes in the amplitude of the pulse plethysmograph (PPG) waveform. This can be continuously quantitaed using the Perfusion Index (PI), a ratio of the pulsatile to nonpulsatile signal amplitude in the PPG waveform. We hypothesized that the perfusion index would rise with the induction of anesthesia in children, and fall with emergence, and performed a prospective, observational study to test this. Our primary aim was to test whether the different clinical stages of anesthesia were associated with changes in the perfusion index, and the secondary aim was to test the correlation between the normalized perfusion index and the MAC value. Twenty-one patients between the ages of 1 and 18 undergoing minor procedures with no anticipated painful stimuli were recruited. Patients with significant illnesses were excluded. Data collection commenced with a preinduction baseline, and data were collected continuously, with event marking, until completion of the anesthesia and removal of the pulse oximeter. Data collected included perfusion index, heart rate, and anesthetic gas concentration values. A normalized perfusion index was calculated by subtracting the initial baseline perfusion index value from all perfusion index values, allowing changes, from a standardized initial baseline value of zero, to be analyzed. During induction, the mean normalized perfusion index rose from 0.0 to 4.2, and then declined to 0.470 when the patients returned to consciousness. P < 0.001 using repeated measures anova test. The normalized perfusion index was correlated with MAC values (r 2 = 0.33, 95% CI 0.18-0.47, P < 0.01). The perfusion index changed significantly during different stages of anesthesia. There is a significant correlation between the perfusion index, measured by pulse oximetry, and the MAC value, in pediatric patients undergoing minor procedures. © 2016 John Wiley & Sons Ltd.

THE MURINE LOCAL LYMPH NODE ASSAY: AN ALTERNATIVE TEST METHOD FOR THE EVALUATION OF THE POTENTIAL FOR CHEMICALS TO ELICIT ALLERGIC CONTACT DERMATITIS

EPA Science Inventory

ABSTRACT
The process that a new toxicology test method must undergo to attain acceptance and regulatory implementation may seem daunting. As the first test method to undergo Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) review, the local...

Protocol, and practical challenges, for a randomised controlled trial comparing the impact of high intensity interval training against standard care before major abdominal surgery: study protocol for a randomised controlled trial.

PubMed

Woodfield, John; Zacharias, Matthew; Wilson, Genevieve; Munro, Fran; Thomas, Kate; Gray, Andrew; Baldi, James

2018-06-25

Risk factors, such as the number of pre-existing co-morbidities, the extent of the underlying pathology and the magnitude of the required operation, cannot be changed before surgery. It may, however, be possible to improve the cardiopulmonary fitness of the patient with an individualised exercise program. We are performing a randomised controlled trial (RCT) assessing the impact of High Intensity Interval Training (HIIT) on preoperative cardiopulmonary fitness and postoperative outcomes in patients undergoing major abdominal surgery. Consecutive eligible patients undergoing elective abdominal surgery are being randomised to HIIT or standard care in a 1:1 ratio. Participants allocated to HIIT will perform 14 exercise sessions on a stationary cycle ergometer, over a period of 4-6 weeks before surgery. The sessions, which are individualised, aim to start with ten repeated 1-min blocks of intense exercise with a target of reaching a heart rate exceeding 90% of the age predicted maximum, followed by 1 min of lower intensity cycling. As endurance improves, the duration of exercise is increased to achieve five 2-min intervals of high intensity exercise followed by 2 min of lower intensity cycling. Each training session lasts approximately 30 min. The primary endpoint, change in peak oxygen consumption (Peak VO 2 ) measured during cardiopulmonary exercise testing, is assessed at baseline and before surgery. Secondary endpoints include postoperative complications, length of hospital stay and three clinically validated scores: the surgical recovery scale; the postoperative morbidity survey; and the SF-36 quality of life score. The standard deviation for changes in Peak VO 2 will be assessed after the first 30 patients and will be used to calculate the required sample size. We want to assess if 14 sessions of HIIT is sufficient to improve Peak VO 2 by 2 mL/kg/min in patients undergoing major abdominal surgery and to explore the best clinical endpoint for a subsequent RCT designed to assess if improving Peak VO 2 will translate into improving clinical outcomes after surgery. Australian New Zealand Clinical Trials Registry, ACTRN12617000587303 . Registered on 26 April 2017.

Childhood Ataxia: Clinical Features, Pathogenesis, Key Unanswered Questions, and Future Directions

PubMed Central

Ashley, Claire N.; Hoang, Kelly D.; Lynch, David R.; Perlman, Susan L.; Maria, Bernard L.

2013-01-01

Childhood ataxia is characterized by impaired balance and coordination primarily due to cerebellar dysfunction. Friedreich ataxia, a form of childhood ataxia, is the most common multisystem autosomal recessive disease. Most of these patients are homozygous for the GAA repeat expansion located on the first intron of the frataxin gene on chromosome 9. Mutations in the frataxin gene impair mitochondrial function, increase reactive oxygen species, and trigger redistribution of iron in the mitochondria and cytosol. Targeted therapies for Friedreich ataxia are undergoing testing. In addition, a centralized database, patient registry, and natural history study have been launched to support clinical trials in Friedreich ataxia. The 2011 Neurobiology of Disease in Children symposium, held in conjunction with the 40th annual Child Neurology Society meeting, aimed to (1) describe clinical features surrounding Friedreich ataxia, including cardiomyopathy and genetics; (2) discuss recent advances in the understanding of the pathogenesis of Friedreich ataxia and developments of clinical trials; (3) review new investigations of characteristic symptoms; (4) establish clinical and biochemical overlaps in neurodegenerative diseases and possible directions for future basic, translational, and clinical studies. PMID:22859693

Preoperative determination of appropriate cutting line for proximal gastrectomy to avoid postoperative jejunal ulcer.

PubMed

Takahashi, Naoto; Kashimura, Hirotaka; Nimura, Hiroshi; Watanabe, Atsushi; Yano, Kentaro; Aoki, Hiroaki; Koyama, Tomoki; Sasaki, Toshiyuki; Shida, Atsuo; Mitsumori, Norio; Aoki, Teruaki; Kashiwagi, Hideyuki; Yanaga, Katsuhiko

2012-01-01

Although proximal gastrectomy has become a procedure of choice for patients' early cancer in the upper third of stomach, no clinical guide for optimal gastric resection in order to avoid postoperative jejunal ulcer is available. The aim of this study was to investigate whether determining the distribution of parietal and chief cells of the stomach using Congo red test is clinically relevant. The F-line was defined as a boundary line between fundic and intermediate area of the stomach according to the pathological findings in 29 patients who underwent total gastrectomy for early gastric cancer, whereas the f-line was regarded as a boundary line between intermediate and pyloric area. In the additional 6 patients undergoing vagus-preserving proximal gastrectomy with jejunal pouch interposition, endoscopic Congo red test was preoperatively performed to determine the F-f-line. The distances from the pyloric ring to f-line on the lesser and greater curvatures were variable. Long-term outcomes of proximal gastrectomy guided by preoperative endoscopic Congo red test were favorable. It is suggested that preoperative endoscopic Congo red test is useful to determine the appropriate cutting line in order to avoid postoperative jejunal ulcer after proximal gastrectomy.

Comparative analysis of three sperm DNA damage assays and sperm nuclear protein content in couples undergoing assisted reproduction treatment.

PubMed

Simon, L; Liu, L; Murphy, K; Ge, S; Hotaling, J; Aston, K I; Emery, B; Carrell, D T

2014-05-01

Is there an association between sperm DNA damage, measured by three different assays, sperm nuclear protein content and clinical outcomes in assisted reproduction treatment (ART)? Sperm DNA damage measured by terminal deoxynucleotidyltransferase-mediated dUTP nick-end labelling (TUNEL) and the Comet assay were significantly associated with ART outcomes in our single institution study. Abnormal protamine expression is known to be associated with sperm DNA damage and male infertility. A number of studies have shown a significant relationship between sperm DNA damage and ART outcomes. To date, there are no large studies providing direct comparisons of DNA damage tests within the same study population. Thus, the prognostic value for each method remains unknown. Cross-sectional study of 238 men from infertile couples undergoing ART at the University Center for Reproductive Medicine, Utah, USA, between April 2011 and March 2013. Sperm from men undergoing ART were tested for DNA damage using the alkaline Comet assay, TUNEL and flow cytometric chromatin evaluation (FCCE) assays. Histone retention was analysed using the aniline blue staining method, whereas protamine content (proteins P1 and P2) and ratio were analysed using acid urea gel electrophoresis. The prognostic value of each sperm DNA test to predict clinical pregnancy was calculated. Histone retention was associated with sperm DNA damage (P < 0.001), reduced embryo quality (P = 0.005) and clinical pregnancies (P < 0.001). The mean percentage of sperm with DNA damage was significantly higher in sperm from non-pregnant couples compared with that from pregnant couples, as measured by TUNEL assay (15.04 ± 1.16% versus 8.79 ± 0.56%; P < 0.001) and alkaline Comet assay (72.79 ± 2.49% versus 55.86 ± 2.29%; P < 0.001). There was no association between clinical pregnancies and DNA fragmentation index measured by FCCE (12.97 ± 1.46 versus 14.93 ± 1.65; P = 0.379). Of the protamine parameters analysed, only the P1/P2 ratio was associated with sperm count (P = 0.013), men's age (P = 0.037), maturity (P = 0.049) and blastocyst quality (P = 0.012). Histone retention and sperm DNA damage measured by Comet and TUNEL assays were associated with fertilization rate (P < 0.05), embryo quality (P < 0.05) and implantation rate (P < 0.05). A potential drawback of this study is that it is cross-sectional. Generally in such studies there is more than one variable that could cause the effect. Analysing sperm is one part of the equation; there are also a number of female factors that have the potential to influence ART outcomes. Therefore, given the large and well-established role of female factors in infertility, normal sperm DNA integrity and protamination do not necessarily ensure clinical pregnancy in ART. Thus, female factors can reduce the prognostic value of sperm DNA tests. Further, our use of native semen instead of prepared sperm may have iatrogenically increased the DNA damage. Alteration in sperm nuclear protein affects sperm DNA integrity. Further, with the current dataset, TUNEL and Comet assays appeared more predictive of ART success than FCCE. No personal or direct financial support has been received for any of this work. The authors declare no competing interests. N/A.

Safety of carotid endarterectomy while on clopidogrel (Plavix). Clinical article.

PubMed

Wait, Scott D; Abla, Adib A; Killory, Brendan D; Starke, Robert M; Spetzler, Robert F; Nakaji, Peter

2010-10-01

Many patients undergoing carotid endarterectomy (CEA) regularly take clopidogrel, a permanent platelet inhibitor. The authors sought to determine whether taking clopidogrel in the period before CEA leads to more bleeding or other complications. The authors performed a retrospective, institutional review board–approved review of 182 consecutive patients who underwent CEA. Clinical, radiographic, and surgical data were gleaned from hospital and clinic records. Analysis was based on the presence or absence of clopidogrel in patients undergoing CEA and was performed twice by considering clopidogrel use within 8 days and within 5 days of surgery to define the groups. Taking clopidogrel within 8 days before surgery resulted in no statistical increase in any measure of morbidity or death. Taking clopidogrel within 5 days was associated with a small but significant increase in operative blood loss and conservatively managed postoperative neck swelling. No measure of permanent morbidity or death was increased in either clopidogrel group. Findings in this study support the safety of preoperative clopidogrel in patients undergoing CEA.

Effects of a new bicarbonate/lactate-buffered neutral peritoneal dialysis fluid for peritoneal failure in patients undergoing peritoneal dialysis.

PubMed

Hoshino, Taro; Ishii, Hiroki; Kitano, Taisuke; Shindo, Mitsutoshi; Miyazawa, Haruhisa; Yamada, Hodaka; Ito, Kiyonori; Ueda, Yuichiro; Kaku, Yoshio; Hirai, Keiji; Mori, Honami; Ookawara, Susumu; Tabei, Kaoru; Morishita, Yoshiyuki

2016-02-01

The highly concentrated lactate in peritoneal dialysis fluid (PDF) has been considered to contribute to peritoneal failure in patients undergoing PD. A new PDF containing a lower lactate concentration, physiological bicarbonate concentration, and neutral pH (bicarbonate/lactate-buffered neutral PDF) was recently developed. We compared the clinical effects of this bicarbonate/lactate-buffered neutral PDF and a lactate-buffered neutral PDF. Patients undergoing PD were changed from a lactate-buffered neutral PDF to a bicarbonate/lactate-buffered neutral PDF. We then investigated the changes in peritoneal functions as estimated by a peritoneal equilibration test (PET) and the following surrogate markers of peritoneal membrane failure in the drained dialysate: fibrin degradation products (FDP), vascular endothelial growth factor (VEGF), cancer antigen 125 (CA125), interleukin-6 (IL-6), and transforming growth factor beta 1 (TGF-β1). Fourteen patients undergoing PD were enrolled. The PET results were not different before and after use of the bicarbonate/lactate-buffered neutral PDF. The FDP concentration significantly decreased from 15.60 ± 13.90 to 6.04 ± 3.49 μg/mL (p = 0.02) and the VEGF concentration significantly decreased from 37.83 ± 15.82 to 27.70 ± 3.80 pg/mL (p = 0.02), while the CA125 and IL-6 concentrations remained unchanged before and after use of the bicarbonate/lactate-buffered neutral PDF. TGF-β1 was not detected in most patients. The bicarbonate/lactate-buffered neutral PDF decreased the FDP and VEGF concentrations in the drained dialysate. These results suggest that the decreased lactate level achieved by administration of bicarbonate with a neutral pH in PDF may contribute to decreased peritoneal membrane failure in patients undergoing PD.

Prostate-specific antigen (PSA) testing of men in UK general practice: a 10-year longitudinal cohort study

PubMed Central

Young, Grace J; Harrison, Sean; Turner, Emma L; Walsh, Eleanor I; Oliver, Steven E; Ben-Shlomo, Yoav; Evans, Simon; Lane, J Athene; Neal, David E; Hamdy, Freddie C; Donovan, Jenny L; Martin, Richard M; Metcalfe, Chris

2017-01-01

Objectives Cross-sectional studies suggest that around 6% of men undergo prostate-specific antigen (PSA) testing each year in UK general practice (GP). This longitudinal study aims to determine the cumulative testing pattern of men over a 10-year period and whether this testing can be considered equivalent to screening for prostate cancer (PCa). Setting, participants and outcome measures Patient-level data on PSA tests, biopsies and PCa diagnoses were obtained from the UK Clinical Practice Research Datalink (CPRD) for the years 2002 to 2011. The cumulative risks of PSA testing and of being diagnosed with PCa were estimated for the 10-year study period. Associations of a man’s age, region and index of multiple deprivation with the cumulative risk of PSA testing and PCa diagnosis were investigated. Rates of biopsy and diagnosis, following a high test result, were compared with those from the programme of PSA testing in the Prostate Testing for Cancer and Treatment (ProtecT) study. Results The 10-year risk of exposure to at least one PSA test in men aged 45 to 69 years in UK GP was 39.2% (95% CI 39.0 to 39.4%). The age-specific risks ranged from 25.2% for men aged 45–49 years to 53.0% for men aged 65–69 years (p for trend <0.001). For those with a PSA level ≥3, a test in UK GP was less likely to result in a biopsy (6%) and/or diagnosis of PCa (15%) compared with ProtecT study participants (85% and 34%, respectively). Conclusion A high proportion of men aged 45–69 years undergo PSA tests in UK GP: 39% over a 10-year period. A high proportion of these tests appear to be for the investigation of lower urinary tract symptoms and not screening for PCa. Trial registration number ISRCTN20141297, NCT02044172. PMID:29084797

Clinical characterisation and cytological study of dry eye in patients with autoimmune disease.

PubMed

Guannan, Huang; Long, Su; Xia, Hua; Dong, Wang; Shaozhen, Zhao

2018-03-01

To assess the clinical characteristics and changes in ocular surface cytology of dry eye in patients with systemic autoimmune disease. The case-control study was conducted in the Second Hospital of Tianjin Medical University, Tianjin, China, from February 2016 to January 2017, and comprised systemic autoimmune disease patients and healthy controls. Schirmer's I test, tear breakup time test, and fluorescein staining were performed on all subjects. Both groups were evaluated for dry eye with the current diagnostic criteria. Conjunctival impression cytology and the morphology of epithelial cells were observed in both groups of subjects. Flow cytometry was used to identify the amount of apoptosis. SPSS 15 was used to analyse the data. Each of the two groups had 60(50%) subjects each. The morbidity of dry eye in the control group was 17(28.3%), while it was 31(51.7%) in the patients (p<0.01). Among the patients with dry eye, the severity level of cells obtained by conjunctival impression sampling was significantly higher in patients than in controls (p<0.01). The percentage of conjunctival epithelial cells undergoing apoptosis was higher in patients with dry eye than in patients without dry eye in each group, and among patients with dry eye, the percentage of conjunctival epithelial cells undergoing apoptosis was higher in the patients than in controls (p<0.01 each). The cell injury on the ocular surface was more serious in subjects with dry eye in systemic autoimmune disease than in subjects with dry eye in healthy controls.

Survey of Intraoperative Bacterial Contamination in Dogs Undergoing Elective Orthopedic Surgery.

PubMed

Andrade, Natalia; Schmiedt, Chad W; Cornell, Karen; Radlinsky, MaryAnn G; Heidingsfelder, Lauren; Clarke, Kevin; Hurley, David J; Hinson, Whitney D

2016-02-01

To investigate the frequency, source, and risk factors of intraoperative (IO) surgeon and patient bacterial contamination during clean orthopedic surgeries, and to investigate the relationship between IO contamination and surgical site infection (SSI) in dogs. Prospective clinical study. Client-owned dogs undergoing stifle surgery (n = 100). IO cultures were taken in each case from surgical foot wrap, peri-incisional skin, surgical gloves, and the surgical team's hands. The environment (operating room [OR] lights, computers, scrub sink faucet, anesthesia gurney, and radiology table) was sampled every 5 months. Bacteria were identified and the contamination of each case was categorized. All gloves from the surgical team were collected and tested for perforations using a water infusion test. Cases were followed for at least 8 weeks to determine the presence or absence of SSI. Perioperative variables were evaluated for association with IO contamination and SSI. Bacterial isolates were yielded from 81% of procedures from 1 or more sources; 58% had positive hand cultures, 46% had positive glove cultures, 23% had positive patient skin cultures, and 12% had positive foot wrap cultures. Staphylococcus spp. was the most commonly recovered bacteria. There was no apparent association between IO contamination and SSI. The highest level of environmental contamination was associated with the scrub sink faucet, followed by the radiology table, anesthesia gurney, and OR computers. The IO glove perforation rate was 18%. Clean orthopedic procedures commonly had clinically insignificant bacterial contamination. In our study, bacteria responsible for SSI did not appear to colonize the patient in the OR. © Copyright 2016 by The American College of Veterinary Surgeons.

Colorectal Liver Metastases: Does the Future of Precision Medicine Lie in Genetic Testing?

PubMed

Barbon, Carlotta; Margonis, Georgios Antonios; Andreatos, Nikolaos; Rezaee, Neda; Sasaki, Kazunari; Buettner, Stefan; Damaskos, Christos; Pawlik, Timothy M; He, Jin; Wolfgang, Christopher L; Weiss, Matthew J

2018-04-11

Colorectal liver metastases (CRLM) present an important clinical challenge in both surgical and medical oncology. Despite improvements in management, survival among patients undergoing resection of CRLM is still very variable and there is a paucity of clinical trial data and reliable biomarkers that could guide prognostic forecasts, treatment selection, and follow-up. Fortunately, recent advances in molecular biology and tumor sequencing have identified a number of critical genetic loci and proliferation markers that may hold the key to understanding the biologic behavior of CRLM; specifically, mutations of KRAS, BRAF, TP53, PIK3CA, APC, expression of Ki-67, and the presence of microsatellite instability appear to have a decisive impact on prognosis and response to treatment in patients with CRLM. While the applicability of genetic biomarkers in everyday clinical practice remains conditional on the development of inexpensive bedside sequencing, targeted therapies, and the conduct of appropriate clinical trials, the promise of personalized treatment may be closer to realization than ever before.

The effect of telehealth systems and satisfaction with health expenditure among patients with metabolic syndrome.

PubMed

Uei, Shu-Lin; Tsai, Chung-Hung; Kuo, Yu-Ming

2016-04-29

Telehealth cost analysis has become a crucial issue for governments in recent years. In this study, we examined cases of metabolic syndrome in Hualien County, Taiwan. This research adopted the framework proposed by Marchand to establish a study process. In addition, descriptive statistics, a t test, analysis of variance, and regression analysis were employed to analyze 100 questionnaires. The results of the t$ test revealed significant differences in medical health expenditure, number of clinical visits for medical treatment, average amount of time spent commuting to clinics, amount of time spent undergoing medical treatment, and average number of people accompanying patients to medical care facilities or assisting with other tasks in the past one month, indicating that offering telehealth care services can reduce health expenditure. The statistical analysis results revealed that customer satisfaction has a positive effect on reducing health expenditure. Therefore, this study proves that telehealth care systems can effectively reduce health expenditure and directly improve customer satisfaction with medical treatment.

Assessing Behavioural Manifestations Prior to Clinical Diagnosis of Huntington Disease: "Anger and Irritability" and "Obsessions and Compulsions"

PubMed Central

Vaccarino, Anthony L; Anonymous; Anderson, Karen E.; Borowsky, Beth; Coccaro, Emil; Craufurd, David; Endicott, Jean; Giuliano, Joseph; Groves, Mark; Guttman, Mark; Ho, Aileen K; Kupchak, Peter; Paulsen, Jane S.; Stanford, Matthew S.; van Kammen, Daniel P; Watson, David; Wu, Kevin D; Evans, Ken

2011-01-01

The Functional Rating Scale Taskforce for pre-Huntington Disease (FuRST-pHD) is a multinational, multidisciplinary initiative with the goal of developing a data-driven, comprehensive, psychometrically sound, rating scale for assessing symptoms and functional ability in prodromal and early Huntington disease (HD) gene expansion carriers. The process involves input from numerous sources to identify relevant symptom domains, including HD individuals, caregivers, and experts from a variety of fields, as well as knowledge gained from the analysis of data from ongoing large-scale studies in HD using existing clinical scales. This is an iterative process in which an ongoing series of field tests in prodromal (prHD) and early HD individuals provides the team with data on which to make decisions regarding which questions should undergo further development or testing and which should be excluded. We report here the development and assessment of the first iteration of interview questions aimed to assess "Anger and Irritability" and "Obsessions and Compulsions" in prHD individuals. PMID:21826116

Likelihood of myocardial infarction during stroke rehabilitation preceded by cardiovascular screening and an exercise tolerance test: the Locomotor Experience Applied Post-Stroke (LEAPS) trial.

PubMed

Nadeau, Stephen E; Rose, Dorian Kay; Dobkin, Bruce; Wu, Samuel S; Dai, Yufeng E; Schofield, Richard; Duncan, Pamela W

2014-12-01

Coronary artery disease is highly prevalent in patients with stroke, but because revascularization does not improve major clinical outcomes in patients with stable coronary artery disease relative to intensive medical therapy, routine evaluation for this disease is not warranted in stroke patients. However, it might be warranted in patients destined to undergo vigorous physical therapy. The Locomotor Experience Applied Post-Stroke study, a randomized controlled trial of 408 participants that tested the relative efficacy of two rehabilitation techniques on functional walking level, provided the opportunity to address this question. The study aims to test the efficacy of screening for cardiovascular disease and an exercise tolerance test in assuring safety among patients undergoing vigorous rehabilitation for gait impairment. All participants were screened for serious cardiovascular and pulmonary conditions. At six-weeks poststroke, they also completed a cardiovascular screening inventory and underwent an exercise tolerance test involving bicycle ergometry. Participants received 36, 90-min sessions of a prescribed physical therapy (three per week), initiated at either two-months or six-months poststroke. Twenty-nine participants were excluded on the basis of the cardiac screening questionnaire, and 15 failed the exercise tolerance test for cardiovascular reasons. No participant experienced a cardiac event during a treatment session. Two participants experienced myocardial infarctions, but continued in the trial. In three additional participants, myocardial infarctions caused or contributed to death. The combination of a negative cardiac screen and the absence of exercise tolerance test failure appeared to have a high negative predictive value for cardiac events during treatment, despite the likelihood of a high prevalence of coronary artery disease in our population. © 2014 World Stroke Organization.

Contraindications for video capsule endoscopy

PubMed Central

Bandorski, Dirk; Kurniawan, Niehls; Baltes, Peter; Hoeltgen, Reinhard; Hecker, Matthias; Stunder, Dominik; Keuchel, Martin

2016-01-01

Video capsule endoscopy (VCE) has been applied in the last 15 years in an increasing field of applications. Although many contraindications have been put into perspective, some precautions still have to be considered. Known stenosis of the gastrointestinal tract is a clear contraindication for VCE unless surgery is already scheduled or at least has been considered as an optional treatment modality. In patients with a higher incidence of stenosis, as in an established diagnosis of Crohn’s disease, clinical signs of obstruction, prior radiation or surgical small bowel resection, a preceding test with the self-dissolving patency capsule can override this contraindication. Endoscopic placement of the capsule should be considered in patients with swallowing disorders to avoid aspiration. Esophageal or gastric motility disorders may require endoscopic capsule transport or application of prokinetics if the real-time viewer proofs delayed transit. In pregnant women, VCE should be restricted to urgent cases where diagnosis cannot be postponed after delivery, as data on safety are missing. There is theoretical and clinical evidence that patients with implanted cardiac devices such as a pacemaker, cardioverters or left heart assist devices, can safely undergo VCE in spite of still existing contraindication by manufacturers. Children from the age of 2 years have safely undergone VCE. Although video capsules are not proven safe with magnetic resonance imaging (MRI), first single cases of patients incidentally undergoing MRI with an incorporated capsule have been reported, showing susceptibility artifacts but no signs of clinical harm. PMID:28018097

Residual Prolapse in Patients with III-IV Degree Haemorrhoids Undergoing Stapled Haemorrhoidopexy with CPH34 HV: Results of an Italian Multicentric Clinical Study

PubMed Central

Reboa, Giuliano; Gipponi, Marco; Ciotta, Giovanni; Tarantello, Marco; Caviglia, Angelo; Pagliazzo, Antonio; Masoni, Luigi; Caldarelli, Giuseppe; Gaj, Fabio; Masci, Bruno; Verdi, Andrea

2014-01-01

CPH34 HV, a high volume stapler, was tested in order to assess its safety and efficacy in reducing residual/recurrent haemorrhoids. The clinical charts of 430 patients with third- to fourth-degree haemorrhoids undergoing SH in 2012-2013 were consecutively reviewed, excluding those with obstructed defecation (rectocele >2 cm; Wexner's score >15). Follow-up was scheduled at six and 12 months. Rectal prolapse exceeding more than half of CAD was reported in 341 patients (79.3%); one technical failure was reported (0.2%) without any serious untoward effect; and 1.3 stitch/patient (SD, 1.7) was required to achieve complete haemostasis. Doughnuts volume was higher (13.8 mL; SD, 1.5) in patients with a large rectal prolapse than with smaller one (8.9 mL; SD, 0.7) (P value <0.05). Residual and recurrent haemorrhoids occurred in 8 of 430 patients (1.8%) and 5 of 254 patients (1.9%), respectively. A high index of patient satisfaction (visual analogue scale = 8.9; SD, 0.9) coupled with a persistent reduction of constipation scores (CSS = 5.0, SD, 2.2) was observed. The wider prolapse resection well correlated with a clear-cut reduction of haemorrhoidal relapse, a high index of patient satisfaction, and clinically relevant reduction of constipations scores coupled with satisfactory haemostatic properties of CPH34 HV. PMID:25478602

Biosimilars in Inflammatory Bowel Disease: Facts and Fears of Extrapolation.

PubMed

Ben-Horin, Shomron; Vande Casteele, Niels; Schreiber, Stefan; Lakatos, Peter Laszlo

2016-12-01

Biologic drugs such as infliximab and other anti-tumor necrosis factor monoclonal antibodies have transformed the treatment of immune-mediated inflammatory conditions such as Crohn's disease and ulcerative colitis (collectively known as inflammatory bowel disease [IBD]). However, the complex manufacturing processes involved in producing these drugs mean their use in clinical practice is expensive. Recent or impending expiration of patents for several biologics has led to development of biosimilar versions of these drugs, with the aim of providing substantial cost savings and increased accessibility to treatment. Biosimilars undergo an expedited regulatory process. This involves proving structural, functional, and biological biosimilarity to the reference product (RP). It is also expected that clinical equivalency/comparability will be demonstrated in a clinical trial in one (or more) sensitive population. Once these requirements are fulfilled, extrapolation of biosimilar approval to other indications for which the RP is approved is permitted without the need for further clinical trials, as long as this is scientifically justifiable. However, such justification requires that the mechanism(s) of action of the RP in question should be similar across indications and also comparable between the RP and the biosimilar in the clinically tested population(s). Likewise, the pharmacokinetics, immunogenicity, and safety of the RP should be similar across indications and comparable between the RP and biosimilar in the clinically tested population(s). To date, most anti-tumor necrosis factor biosimilars have been tested in trials recruiting patients with rheumatoid arthritis. Concerns have been raised regarding extrapolation of clinical data obtained in rheumatologic populations to IBD indications. In this review, we discuss the issues surrounding indication extrapolation, with a focus on extrapolation to IBD. Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.

Measuring pain in patients undergoing hemodialysis: a review of pain assessment tools

PubMed Central

Upadhyay, Chandani; Cameron, Karen; Murphy, Laura; Battistella, Marisa

2014-01-01

Background Patients undergoing hemodialysis frequently report pain with multifactorial causes, not limited to that experienced directly from hemodialysis treatment. Their pain may be nociceptive, neuropathic, somatic or visceral in nature. Despite this, pain in this population remains under-recognized and under-treated. Although several tools have been used to measure pain in patients undergoing hemodialysis as reported in the literature, none of them have been validated specifically in this population. The objective for this review was to compare and contrast these pain assessment tools and discuss their clinical utility in this patient population. Methods To identify pain assessment tools studied in patients undergoing hemodialysis, a literature search was performed in PubMed and Medline. An expert panel of dialysis and pain clinicians reviewed each tool. Each pain assessment tool was assessed on how it is administered and scored, its psychometric properties such as reliability, validity and responsiveness to change, and its clinical utility in a hemodialysis population. Brief Pain Inventory, McGill Pain Questionnaire, Pain Management Index, Edmonton Symptom Assessment System, Visual Analogue Scale and Faces Pain Scale were evaluated and compared. Results This assessment will help clinicians practicing in nephrology to determine which of these pain assessment tools is best suited for use in their individual clinical practice. PMID:25852910

Can virtual reality exposure therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral assessments.

PubMed

Morina, Nexhmedin; Ijntema, Hiske; Meyerbröker, Katharina; Emmelkamp, Paul M G

2015-11-01

In virtual reality exposure therapy (VRET), patients are exposed to virtual environments that resemble feared real-life situations. The aim of the current study was to assess the extent to which VRET gains can be observed in real-life situations. We conducted a meta-analysis of clinical trials applying VRET to specific phobias and measuring treatment outcome by means of behavioral laboratory tests or recordings of behavioral activities in real-life. Data sources were searches of databases (Medline, PsycInfo, and Cochrane). We included in total 14 clinical trials on specific phobias. Results revealed that patients undergoing VRET did significantly better on behavioral assessments following treatment than before treatment, with an aggregated uncontrolled effect size of g = 1.23. Furthermore, patients undergoing VRET performed better on behavioral assessments at post-treatment than patients on wait-list (g = 1.41). Additionally, results of behavioral assessment at post-treatment and at follow-up revealed no significant differences between VRET and exposure in vivo (g = -0.09 and 0.53, respectively). Finally, behavioral measurement effect sizes were similar to those calculated from self-report measures. The findings demonstrate that VRET can produce significant behavior change in real-life situations and support its application in treating specific phobias. Copyright © 2015 Elsevier Ltd. All rights reserved.

Day surgery and recovery in women with a suspicious breast lesion: evaluation of a psychoeducational nursing intervention.

PubMed

Allard, Nicole

2006-01-01

The study assessed whether a nursing intervention based on self-regulation theory, the Attentional Focus and Symptom Management Intervention (AFSMI), could help women who underwent day surgery for breast cancer to achieve better pain management and decreased emotional distress. The sample consisted of 117 patients with breast cancer who were outpatients and undergoing surgery as part of the initial treatment for their cancer. All subjects were interviewed at three different occasions. The subjects were randomized into the experimental group (n = 61) or the usual care group (control, n = 56). The subjects in the experimental group received the intervention in two sessions, 3-4 days and 10-11 days after surgery. The outcomes were the subjects' pain and emotional distress. Results showed significant differences between the experimental and control group at post-test on home management, total mood disturbance, confusion and tension scores implying that the intervention was effective in achieving these outcomes. Clinical significance has illustrated that a nursing intervention applied during immediate recovery of breast cancer surgery is quite clinically relevant to reduce emotional distress. Self-regulation theory could effectively be used as a guide in developing nursing intervention programs in practice for patients with cancer undergoing day surgery as a primary treatment.

Factors Associated With Anthropometric Indicators of Nutritional Status in Children With Chronic Kidney Disease Undergoing Peritoneal Dialysis, Hemodialysis, and After Kidney Transplant.

PubMed

García De Alba Verduzco, Julieta; Hurtado López, Erika Fabiola; Pontón Vázquez, Consuelo; de la Torre Serrano, Adriana; Romero Velarde, Enrique; Vásquez Garibay, Edgar Manuel

2018-05-11

The objective of the study was to demonstrate that there are differences in the factors associated with anthropometric indicators of nutritional status, with particular emphasis on arm indicators, in children with end-stage kidney disease undergoing peritoneal dialysis (PD), hemodialysis (HD), and after kidney transplant (KT). An analytical cross-sectional study of consecutive cases included 130 children and adolescents with end-stage kidney disease undergoing substitutive treatment: 49 patients who underwent KT, 33 undergoing PD, and 47 undergoing HD. Socioeconomic data were obtained from all the 3 groups; anthropometric indicators of nutritional status were calculated. Student's t-test and analysis of variance were used for parametric variables. Chi-square test, Mann-Whitney U test, Kruskal-Wallis test, and odds ratio (OR) were used for nonparametric variables. The number of parents living as couples was higher for patients who underwent KT (OR = 3.5 [95% confidence interval {CI} 1.34-9.0]) and undergoing PD (OR = 3.0 [95% CI 1.06-8.8]) than those undergoing HD. The number of mothers who worked outside the home was higher for patients who underwent KT and undergoing PD than the mothers of patients undergoing HD (OR = 13.7 [95% CI: 4.56-41.05]; OR = 15.4 [CI 95% 4.8-49], respectively). Family income was higher for patients who underwent KT and undergoing PD (P = .019, P = .093, respectively). More than 40% of patients in all the 3 groups had growth impairment. Body mass index, mid-upper arm circumference, tricipital and subscapular skinfolds, total arm area, and arm fat area were affected in HD and PD groups (9 to 40%), while of the patients who underwent KT, 36.7% were overweight or obese. More than 50% of patients who underwent KT and undergoing HD and PD had involvement in the arm muscular area. Socioeconomic conditions are more influential for children in the HD program. The nutritional status of children after KT improves; however, not all anthropometric indicators are fully recovered. Children after KT are up to 9 times more likely to be overweight or obese. Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Comparison of high glucose concentration blood and crystalloid cardioplegia in paediatric cardiac surgery: a randomized clinical trial

PubMed Central

Mimic, Branko; Ilic, Slobodan; Vulicevic, Irena; Milovanovic, Vladimir; Tomic, Danijela; Mimic, Ana; Stankovic, Sanja; Zecevic, Tatjana; Davies, Ben; Djordjevic, Miroslav

2016-01-01

OBJECTIVES This study investigates the effects of high glucose content on patients undergoing cold crystalloid versus cold blood cardioplegia in terms of early clinical results, functional myocardial recovery and ischaemia–reperfusion injury in patients undergoing repair of acyanotic cardiac lesions. METHODS Patients were randomly assigned to receive either crystalloid (n = 31) or blood cardioplegia (n = 31). Early clinical results were assessed. Changes in left ventricular fractional shortening, arterial blood lactate levels, central venous saturation, cardiac Troponin I release and blood glucose concentration were measured during the first 24 h after ischaemia. RESULTS There was no significant difference in clinical outcomes and postoperative complication rates between groups. The postoperative changes in left ventricular function, lactate levels, central venous saturation and Troponin I were not significantly different between groups. The use of crystalloid cardioplegia was associated with significant increases in serum glucose compared with blood cardioplegia. CONCLUSIONS A high glucose content blood cardioplegia does not show any advantage compared with crystalloid cardioplegia in terms of clinical outcomes, functional recovery and the degree of ischaemic injury in infants and children undergoing repair of acyanotic heart lesions. High glucose concentration of the cardioplegic solution might potentiate ischaemia–reperfusion injury and diminish the beneficial effects of blood cardioplegia. PMID:26831677

Optimization of the decision-making process for the selection of therapeutics to undergo clinical testing for spinal cord injury in the North American Clinical Trials Network.

PubMed

Guest, James; Harrop, James S; Aarabi, Bizhan; Grossman, Robert G; Fawcett, James W; Fehlings, Michael G; Tator, Charles H

2012-09-01

The North American Clinical Trials Network (NACTN) includes 9 clinical centers funded by the US Department of Defense and the Christopher Reeve Paralysis Foundation. Its purpose is to accelerate clinical testing of promising therapeutics in spinal cord injury (SCI) through the development of a robust interactive infrastructure. This structure includes key committees that serve to provide longitudinal guidance to the Network. These committees include the Executive, Data Management, and Neurological Outcome Assessments Committees, and the Therapeutic Selection Committee (TSC), which is the subject of this manuscript. The NACTN brings unique elements to the SCI field. The Network's stability is not restricted to a single clinical trial. Network members have diverse expertise and include experts in clinical care, clinical trial design and methodology, pharmacology, preclinical and clinical research, and advanced rehabilitation techniques. Frequent systematic communication is assigned a high value, as is democratic process, fairness and efficiency of decision making, and resource allocation. This article focuses on how decision making occurs within the TSC to rank alternative therapeutics according to 2 main variables: quality of the preclinical data set, and fit with the Network's aims and capabilities. This selection process is important because if the Network's resources are committed to a therapeutic, alternatives cannot be pursued. A proposed methodology includes a multicriteria decision analysis that uses a Multi-Attribute Global Inference of Quality matrix to quantify the process. To rank therapeutics, the TSC uses a series of consensus steps designed to reduce individual and group bias and limit subjectivity. Given the difficulties encountered by industry in completing clinical trials in SCI, stable collaborative not-for-profit consortia, such as the NACTN, may be essential to clinical progress in SCI. The evolution of the NACTN also offers substantial opportunity to refine decision making and group dynamics. Making the best possible decisions concerning therapeutics selection for trial testing is a cornerstone of the Network's function.

Similar cerebral protective effectiveness of antegrade and retrograde cerebral perfusion during deep hypothermic circulatory arrest in aortic surgery: a meta-analysis of 7023 patients.

PubMed

Guo, Shasha; Sun, Yanhua; Ji, Bingyang; Liu, Jinping; Wang, Guyan; Zheng, Zhe

2015-04-01

In aortic arch surgery, deep hypothermic circulatory arrest (DHCA) combined with cerebral perfusion is employed worldwide as a routine practice. Even though antegrade cerebral perfusion (ACP) is more widely used than retrograde cerebral perfusion (RCP), the difference in benefit and risk between ACP and RCP during DHCA is uncertain. The purpose of this meta-analysis is to compare neurologic outcomes and early mortality between ACP and RCP in patients who underwent aortic surgery during DHCA. PubMed, EMBASE, and the Cochrane Library were searched using the key words "antegrade," "retrograde," "cerebral perfusion," "cardiopulmonary bypass," "extracorporeal circulation," and "cardiac surgery" for studies reporting on clinical endpoints including early mortality, stroke, temporary neurologic dysfunction (TND), and permanent neurologic dysfunction (PND) in aortic surgery requiring DHCA with ACP or RCP. Heterogeneity was analyzed with the Cochrane Q statistic and I(2) statistic. Publication bias was tested with Begg's funnel plot and Egger's test. Thirty-four studies were included in this meta-analysis, with 4262 patients undergoing DHCA + ACP and 2761 undergoing DHCA + RCP. The overall pooled relative risk for TND was 0.722 (95% CI = [0.579, 0.900]), and the z-score for overall effect was 2.9 (P = 0.004). There was low heterogeneity (I(2) = 18.7%). The analysis showed that patients undergoing DHCA + ACP had better outcomes than those undergoing DHCA + RCP in terms of TND, while there were no significant differences between groups in terms of PND, stroke, and early mortality. This meta-analysis indicates that DHCA + ACP has an advantage over DHCA + RCP in terms of TND, while the two methods show similar results in terms of PND, early mortality, and stroke. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Accuracy of cystatin C for the detection of abnormal renal function in children undergoing chemotherapy for malignancy: a systematic review using individual patient data.

PubMed

Whiting, Penny; Birnie, Kate; Sterne, Jonathan A C; Jameson, Catherine; Skinner, Rod; Phillips, Bob

2018-05-01

We conducted a systematic review and individual patient data (IPD) meta-analysis to examine the utility of cystatin C for evaluation of glomerular function in children with cancer. Eligible studies evaluated the accuracy of cystatin C for detecting poor renal function in children undergoing chemotherapy. Study quality was assessed using QUADAS-2. Authors of four studies shared IPD. We calculated the correlation between log cystatin C and GFR stratified by study and measure of cystatin C. We dichotomized the reference standard at GFR 80 ml/min/1.73m 2 and stratified cystatin C at 1 mg/l, to calculate sensitivity and specificity in each study and according to age group (0-4, 5-12, and ≥ 13 years). In sensitivity analyses, we investigated different GFR and cystatin C cut points. We used logistic regression to estimate the association of impaired renal function with log cystatin C and quantified diagnostic accuracy using the area under the ROC curve (AUC). Six studies, which used different test and reference standard thresholds, suggested that cystatin C has the potential to monitor renal function in children undergoing chemotherapy for malignancy. IPD data (504 samples, 209 children) showed that cystatin C has poor sensitivity (63%) and moderate specificity (89%), although use of a GFR cut point of < 60 ml/min/1.73m 2 (data only available from two of the studies) estimated sensitivity to be 92% and specificity 81.3%. The AUC for the combined data set was 0.890 (95% CI 0.826, 0.951). Diagnostic accuracy appeared to decrease with age. Cystatin C has better diagnostic accuracy than creatinine as a test for glomerular dysfunction in young people undergoing treatment for cancer. Diagnostic accuracy is not sufficient for it to replace current reference standards for predicting clinically relevant impairments that may alter dosing of important nephrotoxic agents.

Assessing the Risk of Contrast-Induced Nephropathy Using a Finger Stick Analysis in Recalls from Breast Screening: The CINFIBS Explorative Study.

PubMed

Houben, I P L; van Berlo, C J L Y; Bekers, O; Nijssen, E C; Lobbes, M B I; Wildberger, J E

2017-01-01

To evaluate whether a handheld point-of-care (POC) device is able to predict and discriminate patients at potential risk of contrast-induced nephropathy (CIN) prior to iodine-based contrast media delivery. Between December 2014 and June 2016, women undergoing contrast-enhanced spectral mammography (CESM) with an iodine-based contrast agent were asked to have their risk of CIN assessed by a dedicated POC device (StatSensor CREAT) and a risk factor questionnaire based on national guidelines. Prior to contrast injection, a venous blood sample was drawn to compare the results of POC with regular laboratory testing. A total of 351 patients were included; 344 were finally categorized as low risk patients by blood creatinine evaluation. Seven patients had a eGFR below 60 ml/min/1.73 m 2 , necessitating additional preparation prior to contrast delivery. The POC device failed to categorize six out of seven patients (86%), leading to (at that stage) unwanted contrast administration. Two patients subsequently developed CIN after 2-5 days, which was self-limiting after 30 days. The POC device tested was not able to reliably assess impairment of renal function in our patient cohort undergoing CESM. Consequently, we still consider classic clinical laboratory testing preferable in patients at potential risk for developing CIN.

Using Workflow Modeling to Identify Areas to Improve Genetic Test Processes in the University of Maryland Translational Pharmacogenomics Project.

PubMed

Cutting, Elizabeth M; Overby, Casey L; Banchero, Meghan; Pollin, Toni; Kelemen, Mark; Shuldiner, Alan R; Beitelshees, Amber L

Delivering genetic test results to clinicians is a complex process. It involves many actors and multiple steps, requiring all of these to work together in order to create an optimal course of treatment for the patient. We used information gained from focus groups in order to illustrate the current process of delivering genetic test results to clinicians. We propose a business process model and notation (BPMN) representation of this process for a Translational Pharmacogenomics Project being implemented at the University of Maryland Medical Center, so that personalized medicine program implementers can identify areas to improve genetic testing processes. We found that the current process could be improved to reduce input errors, better inform and notify clinicians about the implications of certain genetic tests, and make results more easily understood. We demonstrate our use of BPMN to improve this important clinical process for CYP2C19 genetic testing in patients undergoing invasive treatment of coronary heart disease.

Using Workflow Modeling to Identify Areas to Improve Genetic Test Processes in the University of Maryland Translational Pharmacogenomics Project

PubMed Central

Cutting, Elizabeth M.; Overby, Casey L.; Banchero, Meghan; Pollin, Toni; Kelemen, Mark; Shuldiner, Alan R.; Beitelshees, Amber L.

2015-01-01

Delivering genetic test results to clinicians is a complex process. It involves many actors and multiple steps, requiring all of these to work together in order to create an optimal course of treatment for the patient. We used information gained from focus groups in order to illustrate the current process of delivering genetic test results to clinicians. We propose a business process model and notation (BPMN) representation of this process for a Translational Pharmacogenomics Project being implemented at the University of Maryland Medical Center, so that personalized medicine program implementers can identify areas to improve genetic testing processes. We found that the current process could be improved to reduce input errors, better inform and notify clinicians about the implications of certain genetic tests, and make results more easily understood. We demonstrate our use of BPMN to improve this important clinical process for CYP2C19 genetic testing in patients undergoing invasive treatment of coronary heart disease. PMID:26958179

Emergence of a New Pathogenic Ehrlichia Species, Wisconsin and Minnesota, 2009

PubMed Central

Pritt, Bobbi S.; Sloan, Lynne M.; Johnson, Diep K. Hoang; Munderloh, Ulrike G.; Paskewitz, Susan M.; McElroy, Kristina M.; McFadden, Jevon D.; Binnicker, Matthew J.; Neitzel, David F.; Liu, Gongping; Nicholson, William L.; Nelson, Curtis M.; Franson, Joni J.; Martin, Scott A.; Cunningham, Scott A.; Steward, Christopher R.; Bogumill, Kay; Bjorgaard, Mary E.; Davis, Jeffrey P.; McQuiston, Jennifer H.; Warshauer, David M.; Wilhelm, Mark P.; Patel, Robin; Trivedi, Vipul A.; Eremeeva, Marina E.

2012-01-01

Background Ehrlichiosis is a clinically important, emerging zoonosis. Only Ehrlichia chaffeensis and E. ewingii have been thought to cause ehrlichiosis in humans in the United States. Patients with suspected ehrlichiosis routinely undergo testing to ensure proper diagnosis and to ascertain the cause. Methods We used molecular methods, culturing, and serologic testing to diagnose and ascertain the cause of cases of ehrlichiosis. Results On testing, four cases of ehrlichiosis in Minnesota or Wisconsin were found not to be from E. chaffeensis or E. ewingii and instead to be caused by a newly discovered ehrlichia species. All patients had fever, malaise, headache, and lymphopenia; three had thrombocytopenia; and two had elevated liver-enzyme levels. All recovered after receiving doxycycline treatment. At least 17 of 697 Ixodes scapularis ticks collected in Minnesota or Wisconsin were positive for the same ehrlichia species on polymerase-chain-reaction testing. Genetic analyses revealed that this new ehrlichia species is closely related to E. muris. Conclusions We report a new ehrlichia species in Minnesota and Wisconsin and provide supportive clinical, epidemiologic, culture, DNA-sequence, and vector data. Physicians need to be aware of this newly discovered close relative of E. muris to ensure appropriate testing, treatment, and regional surveillance. (Funded by the National Institutes of Health and the Centers for Disease Control and Prevention.) PMID:21812671

[Evaluation of psychological fear in children undergoing head-up tilt test].

PubMed

Chu, Wei-Hong; Wu, Li-Jia; Wang, Cheng; Lin, Ping; Li, Fang; Zhu, Li-Ping; Ran, Jing; Zou, Run-Mei; Liu, De-Yu

2014-03-01

To investigate the effects of different tilt angles of head-up tilt test (HUTT) and different responses to HUTT on the psychological fear in children undergoing the test. HUTT was performed on children with unexplained syncope or pre-syncope (107 cases: 52 males and 55 females), aged 5.5-17.8 years (mean 12.0±2.8 years). All subjects were randomly assigned to undergo HUTT at an angle of 60°, 70° or 80°; the negative cases underwent sublingual nitroglycerin-provocation HUTT at the same tilt angle. The Wong-Baker Faces Pain Rating Scale was used for self-assessment of psychological fear in subjects during HUTT at the end point of the test. The positive rate, hemodynamic changes and distribution of response types showed no significant differences between children at tilt angles of 60°, 70° and 80° (P>0.05). The greater the tilt angle, the higher the degree of psychological fear in children undergoing the test, but there were no significant differences between them (P>0.05). The degree of psychological fear in children who showed a positive response to HUTT (n=76) was significantly higher than that in children who showed a negative response (n=31) (P<0.01). HUTT can cause psychological fear in children undergoing the test, and the degree of psychological fear increases in children tested at tilt angles from 60° to 80°, but the differences have no statistical significance. A positive response to HUTT can significantly increase the psychological fear in children.

Development of a clinical decision model for thyroid nodules

PubMed Central

Stojadinovic, Alexander; Peoples, George E; Libutti, Steven K; Henry, Leonard R; Eberhardt, John; Howard, Robin S; Gur, David; Elster, Eric A; Nissan, Aviram

2009-01-01

Background Thyroid nodules represent a common problem brought to medical attention. Four to seven percent of the United States adult population (10–18 million people) has a palpable thyroid nodule, however the majority (>95%) of thyroid nodules are benign. While, fine needle aspiration remains the most cost effective and accurate diagnostic tool for thyroid nodules in current practice, over 20% of patients undergoing FNA of a thyroid nodule have indeterminate cytology (follicular neoplasm) with associated malignancy risk prevalence of 20–30%. These patients require thyroid lobectomy/isthmusectomy purely for the purpose of attaining a definitive diagnosis. Given that the majority (70–80%) of these patients have benign surgical pathology, thyroidectomy in these patients is conducted principally with diagnostic intent. Clinical models predictive of malignancy risk are needed to support treatment decisions in patients with thyroid nodules in order to reduce morbidity associated with unnecessary diagnostic surgery. Methods Data were analyzed from a completed prospective cohort trial conducted over a 4-year period involving 216 patients with thyroid nodules undergoing ultrasound (US), electrical impedance scanning (EIS) and fine needle aspiration cytology (FNA) prior to thyroidectomy. A Bayesian model was designed to predict malignancy in thyroid nodules based on multivariate dependence relationships between independent covariates. Ten-fold cross-validation was performed to estimate classifier error wherein the data set was randomized into ten separate and unique train and test sets consisting of a training set (90% of records) and a test set (10% of records). A receiver-operating-characteristics (ROC) curve of these predictions and area under the curve (AUC) were calculated to determine model robustness for predicting malignancy in thyroid nodules. Results Thyroid nodule size, FNA cytology, US and EIS characteristics were highly predictive of malignancy. Cross validation of the model created with Bayesian Network Analysis effectively predicted malignancy [AUC = 0.88 (95%CI: 0.82–0.94)] in thyroid nodules. The positive and negative predictive values of the model are 83% (95%CI: 76%–91%) and 79% (95%CI: 72%–86%), respectively. Conclusion An integrated predictive decision model using Bayesian inference incorporating readily obtainable thyroid nodule measures is clinically relevant, as it effectively predicts malignancy in thyroid nodules. This model warrants further validation testing in prospective clinical trials. PMID:19664278

Pneumococcal urinary antigen test use in diagnosis and treatment of pneumonia in seven Utah hospitals

PubMed Central

West, Devin M.; McCauley, Lindsay M.; Sorensen, Jeffrey S.; Jephson, Al R.

2016-01-01

The pneumocococcal urine antigen test increases specific microbiological diagnosis over conventional culture methods in pneumonia patients. Data are limited regarding its yield and effect on antibiotic prescribing among patients with community-onset pneumonia in clinical practice. We performed a secondary analysis of 2837 emergency department patients admitted to seven Utah hospitals over 2 years with international diagnostic codes version 9 codes and radiographic evidence of pneumonia. Mean age was 64.2 years, 47.2% were male and all-cause 30-day mortality was 9.6%. Urinary antigen testing was performed in 1110 (39%) patients yielding 134 (12%) positives. Intensive care unit patients were more likely to undergo testing, and have a positive result (15% versus 8.8% for ward patients; p<0.01). Patients with risk factors for healthcare-associated pneumonia had fewer urinary antigen tests performed, but 8.4% were positive. Physicians changed to targeted antibiotic therapy in 20 (15%) patients, de-escalated antibiotic therapy in 76 patients (57%). In 38 (28%) patients, antibiotics were not changed. Only one patient changed to targeted therapy suffered clinical relapse. Length of stay and mortality were lower in patients receiving targeted therapy. Pneumococcal urinary antigen testing is an inexpensive, noninvasive test that favourably influenced antibiotic prescribing in a “real world”, multi-hospital observational study. PMID:28053969

Outcomes after elective abdominal aortic aneurysm repair in obese versus nonobese patients.

PubMed

Locham, Satinderjit; Rizwan, Muhammad; Dakour-Aridi, Hanaa; Faateh, Muhammad; Nejim, Besma; Malas, Mahmoud

2018-06-07

Obesity is a worldwide epidemic, particularly in Western society. It predisposes surgical patients to an increased risk of adverse outcomes. The aim of our study was to use a nationally representative vascular database and to compare in-hospital outcomes in obese vs nonobese patients undergoing elective open aortic repair (OAR) and endovascular aneurysm repair (EVAR). All patients undergoing elective abdominal aortic aneurysm repair were identified in the Vascular Quality Initiative database (2003-2017). Obesity was defined as body mass index ≥30 kg/m 2 . Univariable (Student t-test and χ 2  test) and multivariable (logistic regression) analyses were implemented to compare in-hospital mortality and any major complications (wound infection, renal failure, and cardiopulmonary failure) in obese vs nonobese patients. We identified a total of 33,082 patients undergoing elective OAR (nonobese, n = 4605 [72.4%]; obese, n = 1754 [27.6%]) and EVAR (nonobese, n = 18,338 [68.6%]; obese, n = 8385 [31.4%]). Obese patients undergoing OAR and EVAR were relatively younger compared with nonobese patients (mean age [standard deviation], 67.55 [8.26] years vs 70.27 [8.30] years and 71.06 [8.22] years vs 74.55 [8.55] years), respectively; (both P < .001). Regardless of approach, obese patients had slightly longer operative time (OAR, 259.02 [109.97] minutes vs 239.37 [99.78] minutes; EVAR, 138.27 [70.64] minutes vs 134.34 [69.98] minutes) and higher blood loss (OAR, 2030 [1823] mL vs 1619 [1642] mL; EVAR, 228 [354] mL vs 207 [312] mL; both P < .001). There was no significant difference in mortality between the two groups undergoing OAR and EVAR (OAR, 2.9% vs 3.2% [P = .50]; EVAR, 0.5% vs 0.6% [P = .76]). On multivariable analysis, obese patients undergoing OAR had 33% higher odds of renal failure (adjusted odds ratio [OR], 1.33; 95% confidence interval [CI], 1.09-1.63; P = .006) and 75% higher odds of wound infections (adjusted OR, 1.75; 95% CI, 1.11-2.76; P = .02) compared with nonobese patients. However, in patients undergoing EVAR, no association was seen between obesity and any major complications. A significant interaction was found between obesity and surgical approach in the event of renal failure, in which obese patients undergoing OAR had significantly higher odds of renal failure compared with those in the EVAR group (OR interaction , 1.36; 95% CI, 1.05-1.75; P = .02). Using a large nationally representative database, we demonstrated an increased risk of renal failure and wound infections in obese patients undergoing OAR compared with nonobese patients. On the other hand, obesity did not seem to increase the odds of major adverse outcomes in patients undergoing EVAR. Further long-term prospective studies are needed to verify the effects of obesity after abdominal aortic aneurysm repair and the implications of these findings in clinical decision-making. Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Direct injury to right coronary artery in patients undergoing tricuspid annuloplasty.

PubMed

Díez-Villanueva, Pablo; Gutiérrez-Ibañes, Enrique; Cuerpo-Caballero, Gregorio P; Sanz-Ruiz, Ricardo; Abeytua, Manuel; Soriano, Javier; Sarnago, Fernando; Elízaga, Jaime; González-Pinto, Angel; Fernández-Avilés, Francisco

2014-04-01

Direct injury to the right coronary artery as a result of reparative operation on the tricuspid valve is a rare, probably underdiagnosed, but serious complication, which often involves dramatic clinical consequences. So far, only five cases have been described in the literature. We describe our single-center experience of this complication, and review and analyze relevant clinical and anatomic considerations related to this entity. Cases previously reported in the literature were also reviewed. We describe four cases of direct injury to the right coronary artery in patients undergoing tricuspid annuloplasty (DeVega annuloplasty, 3; ring annuloplasty, 1) in our institution since 2005. All patients had right ventricular dilatation and severely dilated tricuspid annulus. Right coronary artery occlusion always occurred between the right marginal artery and the crux of the heart. Patients presented with hemodynamic or electrical instability. Coronary flow could be restored in 2 patients (percutaneously 1; surgically 1), both of whom finally survived, while it was not technically possible in the other 2 (1 died). Occlusion of the right coronary artery in patients undergoing tricuspid annuloplasty is a rare complication that may occur if great annulus dilatation is present, thus altering both normal annular geometry and the relationship between the right coronary artery and the tricuspid annulus, particularly when DeVega annuloplasty is performed. Such an entity should be considered in the immediate postoperative period in an unstable patient, especially when complementary tests support this diagnosis. Prompt recognition and treatment can positively affect the patient's outcome, most often by means of an emergency revascularization strategy. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

The Value of the SYNTAX Score II in Predicting Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Ryan, Nicola; Nombela-Franco, Luis; Jiménez-Quevedo, Pilar; Biagioni, Corina; Salinas, Pablo; Aldazábal, Andrés; Cerrato, Enrico; Gonzalo, Nieves; Del Trigo, María; Núñez-Gil, Iván; Fernández-Ortiz, Antonio; Macaya, Carlos; Escaned, Javier

2017-11-27

The predictive value of the SYNTAX score (SS) for clinical outcomes after transcatheter aortic valve implantation (TAVI) is very limited and could potentially be improved by the combination of anatomic and clinical variables, the SS-II. We aimed to evaluate the value of the SS-II in predicting outcomes in patients undergoing TAVI. A total of 402 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI were included. Preprocedural TAVI angiograms were reviewed and the SS-I and SS-II were calculated using the SS algorithms. Patients were stratified in 3 groups according to SS-II tertiles. The coprimary endpoints were all-cause death and major adverse cardiovascular events (MACE), a composite of all-cause death, cerebrovascular event, or myocardial infarction at 1 year. Increased SS-II was associated with higher 30-day mortality (P=.036) and major bleeding (P=.015). The 1-year risk of death and MACE was higher among patients in the 3rd SS-II tertile (HR, 2.60; P=.002 and HR, 2.66; P<.001) and was similar among patients in the 2nd tertile (HR, 1.27; P=.507 and HR, 1.05; P=.895) compared with patients in the 1st tertile. The highest SS-II tertile was an independent predictor of long-term mortality (P=.046) and MACE (P=.001). The SS-II seems more suited to predict clinical outcomes in patients undergoing TAVI than the SS-I. Increased SS-II was associated with poorer clinical outcomes at 1 and 4 years post-TAVI, independently of the presence of coronary artery disease. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Mentoring in the Clinical Setting to Improve Student Decision-Making Competence

ERIC Educational Resources Information Center

Stick-Mueller, Misty; Boesch, Ron; Silverman, Steven; Carpenter, Scott; Illingworth, Robert; Countryman, James

2010-01-01

Introduction: The physician-intern relationship can be difficult to develop. A new chiropractic intern in a teaching clinic undergoes a major transition from classroom to clinical practice and must learn to turn classroom knowledge into clinical application. The ability to start formulating clinical techniques and apply them on a patient is…

Great expectations: patient perspectives and anticipated utility of non-diagnostic genomic-sequencing results.

PubMed

Hylind, Robyn; Smith, Maureen; Rasmussen-Torvik, Laura; Aufox, Sharon

2018-01-01

The management of secondary findings is a challenge to health-care providers relaying clinical genomic-sequencing results to patients. Understanding patients' expectations from non-diagnostic genomic sequencing could help guide this management. This study interviewed 14 individuals enrolled in the eMERGE (Electronic Medical Records and Genomics) study. Participants in eMERGE consent to undergo non-diagnostic genomic sequencing, receive results, and have results returned to their physicians. The interviews assessed expectations and intended use of results. The majority of interviewees were male (64%) and 43% identified as non-Caucasian. A unique theme identified was that many participants expressed uncertainty about the type of diseases they expected to receive results on, what results they wanted to learn about, and how they intended to use results. Participant uncertainty highlights the complex nature of deciding to undergo genomic testing and a deficiency in genomic knowledge. These results could help improve how genomic sequencing and secondary findings are discussed with patients.

Management of Patients with Orthopaedic Implants Undergoing Dental Procedures.

PubMed

Quinn, Robert H; Murray, Jayson N; Pezold, Ryan; Sevarino, Kaitlyn S

2017-07-01

The American Academy of Orthopaedic Surgeons, in collaboration with the American Dental Association, has developed Appropriate Use Criteria (AUC) for the Management of Patients with Orthopaedic Implants Undergoing Dental Procedures. Evidence-based information, in conjunction with the clinical expertise of physicians, was used to develop the criteria to improve patient care and obtain best outcomes while considering the subtleties and distinctions necessary in making clinical decisions. The Management of Patients with Orthopaedic Implants Undergoing Dental Procedures AUC clinical patient scenarios were derived from indications of patients with orthopaedic implants presenting for dental procedures, as well as from current evidence-based clinical practice guidelines and supporting literature to identify the appropriateness of the use of prophylactic antibiotics. The 64 patient scenarios and 1 treatment were developed by the writing panel, a group of clinicians who are specialists in this AUC topic. Next, a separate, multidisciplinary, voting panel (made up of specialists and nonspecialists) rated the appropriateness of treatment of each patient scenario using a 9-point scale to designate a treatment as Appropriate (median rating, 7 to 9), May Be Appropriate (median rating, 4 to 6), or Rarely Appropriate (median rating, 1 to 3).

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

Anti-citrullinated protein antibody and rheumatoid factor in patients with end-stage renal disease.

PubMed

Romic, Zeljko; Unic, Adriana; Derek, Lovorka; Zivkovic, Marcela; Marijancevic, Domagoj; Kes, Petar; Pehar, Mario

2009-01-01

Patients with end-stage renal disease (ESRD) and on hemodialysis (HD) are at increased risk for developing rheumatoid arthritis (RA), as a result of defective immunity. Our aim was to examine if ESRD and the length of HD treatment impact the clinical utility of antibodies to cyclic citrullinated peptides (anti-CCP) and rheumatoid factor (RF) as diagnostic tools for RA. We included 94 subjects in our study: 37 healthy volunteers and 57 patients with ESRD who had been undergoing HD for 1-12 years, and without confirmed RA. In order to test our hypothesis, we measured and correlated anti-CCP and RF as laboratory markers of RA. Our study showed that there is no significant difference between values for anti-CCP (p=0.11) and RF (p=0.98) in control subjects as well as in patients undergoing HD, regardless of the length of time that patients had been undergoing HD treatment. Our study indicates that HD does not impair the specificity of anti-CCP and RF for RA in patients where the disease has not yet developed. Future prospective studies may show whether there is any use in determinating RF, and especially anti-CCP, as early predictors of RA in patients with ESRD who are at greater risk of developing this condition.

Relationship between cognition and gait performance in older adults receiving physical therapy interventions in the home.

PubMed

Whitney, Susan L; Marchetti, Gregory F; Ellis, Jennifer; Otis, Laurie; Asiri, Faisal; Alghadir, Ahmad

2013-01-01

Persons undergoing physical therapy home services often have difficulty with mobility and gait. The purpose of this study was to determine whether there was a relationship between gait and a rating of cognitive functioning in persons undergoing home-care physical therapy services. Patients over the age of 65 (n = 11,601) seen by a home-care agency between 2007 and 2008 were included in the retrospective analysis, and 10,953 (mean +/- standard deviation age 83.2 +/- 7.1; 31%) met the criteria of being able to ambulate independently or with an assistive device. All patients attempted to perform the modified Clinical Test of Sensory Integration and Balance plus either the Performance Oriented Measurement Assessment (POMA) or the Dynamic Gait Index (DGI). Mental function was scored as part of the Outcome and Assessment Information Set. A multivariate model with adjustment for age and sex identified gait performance as measured by the DGI to be independently associated with the likelihood that a patient required cognitive prompting (p = 0.03). Both the DGI and POMA scores were independently associated with requiring assistance/dependence with cognitive tasks. There was a strong relationship between cognition and gait performance in persons undergoing physical therapy interventions in the home. Changes in gait may be related to cognitive decline.

Neurologic Complications After Cardiac Transplant.

PubMed

Öcal, Ruhsen; Kibaroğlu, Seda; Derle, Eda; Tanoğlu, Ceyda; Camkıran, Aynur; Pirat, Arash; Can, Ufuk; Sezgin, Atilla

2016-06-15

Cardiac transplant is the best available therapy for patients with end-stage heart failure. Neurologic complications occur at a rate of 30% to 70% in patients undergoing cardiac transplant, and they affect mortality and morbidity of these patients. Risk factors for neurologic complications include immunosuppressive medication toxicity, infections, brain lesions, and metabolic disorders. The aim of our study was to determine the incidence of neurologic complications in adult patients undergoing cardiac transplant. We retrospectively evaluated the medical records of 70 patients who underwent cardiac transplant between 2004 and April 2016. We recorded the demographic data, neurologic symptoms, neurologic examination findings, laboratory test results, brain imaging study results, and treatments received of the patients. Of the 70 patients enrolled, 55 were male and 15 were female patients. The age range was 18 to 63 years, and the mean age was 42.4 years. Twelve patients had encephalopathy, 4 had neuropathic pain, 3 had tremor, 2 had ischemic cerebrovascular accident, 7 had posterior reversible encephalopathy syndrome, and 1 had drop foot. Encephalopathy usually developed secondary to other neurologic disorders. The incidence of neurologic complications in adult patients undergoing cardiac transplant was 30%. Neurologic complications are common after cardiac transplant. We observed an incidence of 30% for neurologic complications in our clinic, with encephalopathy being the most common complication. Encephalopathy most commonly developed secondary to posterior reversible encephalopathy syndrome.

Third-space fluid shift in elderly patients undergoing gastrointestinal surgery: Part 1: Pathophysiological mechanisms.

PubMed

Redden, Maurine; Wotton, Karen

2002-06-01

Third-space fluid shift, the movement of body fluid to a non-functional space, is a frequently occurring and potentially fatal clinical phenomenon. Little published research exists however in medical or nursing journals concerning its incidence, significance and ramifications in elderly patients undergoing major gastrointestinal surgery. This initial article, part I, explores fluid movement between fluid compartments and uses these principles to discuss the pathophysiology of the two distinct phases of third-space fluid shift. Part II will examine the criteria nurses could use in the clinical assessment of patients in both first and second phases third-space fluid shift and discuss the clinical reliability of these criteria.

The Virtual Anemia Trial: An Assessment of Model‐Based In Silico Clinical Trials of Anemia Treatment Algorithms in Patients With Hemodialysis

PubMed Central

Topping, Alice; Kappel, Franz; Thijssen, Stephan; Kotanko, Peter

2018-01-01

In silico approaches have been proposed as a novel strategy to increase the repertoire of clinical trial designs. Realistic simulations of clinical trials can provide valuable information regarding safety and limitations of treatment protocols and have been shown to assist in the cost‐effective planning of clinical studies. In this report, we present a blueprint for the stepwise integration of internal, external, and ecological validity considerations in virtual clinical trials (VCTs). We exemplify this approach in the context of a model‐based in silico clinical trial aimed at anemia treatment in patients undergoing hemodialysis (HD). Hemoglobin levels and subsequent anemia treatment were simulated on a per patient level over the course of a year and compared to real‐life clinical data of 79,426 patients undergoing HD. The novel strategies presented here, aimed to improve external and ecological validity of a VCT, significantly increased the predictive power of the discussed in silico trial. PMID:29368434

Burnout and use of HIV services among health care workers in Lusaka District, Zambia: a cross-sectional study

PubMed Central

Kruse, Gina R; Chapula, Bushimbwa Tambatamba; Ikeda, Scott; Nkhoma, Mavis; Quiterio, Nicole; Pankratz, Debra; Mataka, Kaluba; Chi, Benjamin H; Bond, Virginia; Reid, Stewart E

2009-01-01

Background Well-documented shortages of health care workers in sub-Saharan Africa are exacerbated by the increased human resource demands of rapidly expanding HIV care and treatment programmes. The successful continuation of existing programmes is threatened by health care worker burnout and HIV-related illness. Methods From March to June 2007, we studied occupational burnout and utilization of HIV services among health providers in the Lusaka public health sector. Providers from 13 public clinics were given a 36-item, self-administered questionnaire and invited for focus group discussions and key-informant interviews. Results Some 483 active clinical staff completed the questionnaire (84% response rate), 50 staff participated in six focus groups, and four individuals gave interviews. Focus group participants described burnout as feeling overworked, stressed and tired. In the survey, 51% reported occupational burnout. Risk factors were having another job (RR 1.4 95% CI 1.2–1.6) and knowing a co-worker who left in the last year (RR 1.6 95% CI 1.3–2.2). Reasons for co-worker attrition included: better pay (40%), feeling overworked or stressed (21%), moving away (16%), death (8%) and illness (5%). When asked about HIV testing, 370 of 456 (81%) reported having tested; 240 (50%) tested in the last year. In contrast, discussion groups perceived low testing rates. Both discussion groups and survey respondents identified confidentiality as the prime reason for not undergoing HIV testing. Conclusion In Lusaka primary care clinics, overwork, illness and death were common reasons for attrition. Programmes to improve access, acceptability and confidentiality of health care services for clinical providers and to reduce workplace stress could substantially affect workforce stability. PMID:19594917

Gender differences in the clinical management of patients with angina pectoris: a cross-sectional survey in primary care

PubMed Central

Crilly, Mike; Bundred, Peter; Hu, Xiyuan; Leckey, Lisa; Johnstone, Fiona

2007-01-01

Background Previous research suggests that women admitted to hospital with acute myocardial infarction (MI) are managed less intensively than men. Chronic stable angina is the commonest clinical manifestation of coronary heart disease in the community, but little information is available concerning its contemporary clinical management. The aim of this study is to assess the extent of gender differences in the clinical management of angina pectoris in primary care. Methods A cross-sectional survey undertaken in 8 sentinel centres serving 63,724 individuals in the city of Liverpool (15% of the city population). Aspects of clinical care assessed included: risk factor recording (smoking, cholesterol, blood pressure, body mass index); secondary prevention (aspirin, beta-blocker, statin); cardiac investigation (exercise ECG, perfusion scanning, angiography); and revascularisation (percutaneous coronary intervention, coronary artery bypass grafting). Male-to-female adjusted odds ratios (AOR) were calculated (adjusted for age, angina duration, age at diagnosis and previous MI) using logistic regression. Results 1,162 patients (610 men; 552 women) with angina were identified. Women were older than men (71 vs 67 years), with a shorter duration of angina (6 vs 7 years), and a lower prevalence of previous MI (25% vs 43%). Men were significantly more likely than women to undergo detailed risk factor assessment (AOR = 1.35, 95%CI 1.06 to 1.73); receive 'triple' secondary prevention with aspirin, beta-blockers and statins (AOR = 1.47, 95%CI 1.07 to 2.02); access exercise ECG testing (AOR = 1.31, 95%CI 1.02 to 1.68); angiography (AOR = 1.61, 95%CI 1.23 to 2.12); and undergo coronary revascularisation (AOR = 1.93, 95%CI 1.39 to 2.68). Conclusion Systematic gender differences exist in the comprehensive clinical management of patients with angina in primary care. PMID:17784961

Coronary microvascular dysfunction equivalent to left main coronary artery disease.

PubMed

Panç, Cafer; Kocaağa, Mehmet; Erdoğan, Onur; Sarıkaya, Remzi; Umman, Sabahattin

2017-04-01

Coronary microvascular dysfunction, also known as cardiac syndrome X, is a clinical syndrome presenting with typical angina and evidence of myocardial ischemia in the absence of flow-limiting stenosis on coronary angiography. Of patients undergoing coronary angiography due to suspected myocardial ischemia, 50% are found to have normal or near-normal coronary arteries. Described in this case report is a patient who developed hypotension and ST segment depressions during treadmill exercise test. Left main coronary artery or multivessel disease was suspected. Coronary angiography was normal, but coronary flow reserve measurement revealed severe microvascular dysfunction.

Acetylsalicylic acid-triggered 15-HETE generation by peripheral leukocytes for identifying ASA sensitivity.

PubMed

Korosec, Peter; Tisler, Ursa; Bajrovic, Nissera; Silar, Mira; Mrhar, Ales; Kosnik, Mitja

2011-10-01

Exposure to acetylsalicylic acid (ASA) may exacerbate respiratory or skin diseases or induce anaphylactoid reactions in apparently healthy individuals. We wanted to evaluate the clinical and diagnostic utility of measuring ASA-induced 15-hydroxyeicosatetraenoic acid (15-HETE) generation. We performed a prospective single-blind study with 26 subjects undergoing clinical evaluation and/or ASA provocation testing. We also included 12 control subjects. Peripheral blood leukocytes were incubated with 500 μM ASA and 15-HETE release was measured by competitive ELISA. We found that 18 subjects were ASA-tolerant and 8 were ASA-intolerant. The mean increase in 15-HETE in intolerant subjects was 34% and this was comparable to the mean increase of 30% observed in ASA-tolerant subjects. A similar mean increase was also observed in control subjects. The ROC calculation showed that the optimal diagnostic threshold would be an increase of greater than 33%. However, the sensitivity of this increase was only 63% and the specificity was 50%. Our data suggest that further studies are needed before the ASA-induced 15-HETE test can be used in clinical practice. Copyright © 2011 Elsevier Ltd. All rights reserved.

ACR Appropriateness Criteria® Stage I Breast Cancer: Initial Workup and Surveillance for Local Recurrence and Distant Metastases in Asymptomatic Women.

PubMed

Moy, Linda; Bailey, Lisa; D'Orsi, Carl; Green, Edward D; Holbrook, Anna I; Lee, Su-Ju; Lourenco, Ana P; Mainiero, Martha B; Sepulveda, Karla A; Slanetz, Priscilla J; Trikha, Sunita; Yepes, Monica M; Newell, Mary S

2017-05-01

Women and health care professionals generally prefer intensive follow-up after a diagnosis of breast cancer. However, there are no survival differences between women who obtain intensive surveillance with imaging and laboratory studies compared with women who only undergo testing because of the development of symptoms or findings on clinical examinations. American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines state that annual mammography is the only imaging examination that should be performed to detect a localized breast recurrence in asymptomatic patients; more imaging may be needed if the patient has locoregional symptoms (eg, palpable abnormality). Women with other risk factors that increase their lifetime risk for breast cancer may warrant evaluation with breast MRI. Furthermore, the quality of life is similar for women who undergo intensive surveillance compared with those who do not. There is little justification for imaging to detect or rule out metastasis in asymptomatic women with newly diagnosed stage I breast cancer. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

MRI-guided Breast Biopsy: Outcomes and Impact on Patient Management

PubMed Central

Kamel, Ihab R; Macura, Katarzyna J

2014-01-01

Introduction The purpose of this study was to correlate the pathology results of magnetic resonance imaging (MRI)-guided breast biopsies at our institution to MRI findings and patient clinical history characteristics. The impact of MRI-guided breast biopsies on surgical management in patients with a new diagnosis of breast cancer was also assessed. Patients and Methods In this HIPAA-compliant study we retrospectively reviewed all MRI-guided breast biopsies performed 3/2006–5/2012. Clinical history, MRI features and pathology outcomes were reviewed. In patients undergoing breast MRI to evaluate extent of disease, any change in surgical management resulting from the MRI-guided biopsy was recorded. Statistical analysis included binary logistic regression and independent student’s t-test. Results Two-hundred fifteen lesions in 168 patients were included, of which 23 (10.7%) were malignant, 43 (20%) were high risk, and 149 (69.3%) were benign. No clinical characteristic was associated with malignancy in our cohort. MRI features associated with malignancy were: larger size (mean 2.6 cm versus 1.3 cm, p=0.046), washout kinetics (18% malignancy rate, p=0.02) and marked background parenchymal enhancement (40% malignancy rate, p-value <0.001 to 0.03). Nineteen (28%) of the 67 patients with a new diagnosis of breast cancer undergoing MRI-guided breast biopsy had a change in surgical management based on the biopsy result. Conclusions Malignancy rate was associated with lesion size, washout kinetics and marked background enhancement of the breast parenchyma but was not associated with any clinical history characteristics. Pre-operative MRI-guided breast biopsies changed surgical management in 28% of women with a new diagnosis of breast cancer. PMID:25499596

Chronic obstructive pulmonary disease exacerbation in the intensive care unit: clinical, functional and quality of life at discharge and 3 months of follow up

PubMed Central

Viana, Renata Cristina Teixeira Pinto; Pincelli, Mariangela Pimentel; Pizzichini, Emílio; Silva, André Pacheco; Manes, Joice; Marconi, Tatiana Dias; Steidle, Leila John Marques

2017-01-01

Objective The purpose of this study was to evaluate the clinical/functional aspects and quality of life of chronic obstructive pulmonary disease patients who were discharged after an intensive care unit admission for acute respiratory failure. Methods This prospective study included chronic obstructive pulmonary disease patients who were admitted to two intensive care units between December of 2010 and August of 2011 and evaluated over three visits after discharge. Thirty patients were included, and 20 patients completed the three-month follow up. Results There was a significant improvement in the following: forced expiratory flow in one second (L) (1.1/1.4/1.4; p = 0.019), six-minute walk test (m) (- /232.8 /272.6; p = 0.04), BODE score (7.5/5.0/3.8; p = 0.001), cognition measured by the Mini Mental State Examination (21/23.5/23.5; p = 0.008) and quality of life measured by the total Saint George Respiratory Questionnaire score (63.3/56.8/51, p = 0.02). The mean difference in the total score was 12.3 (between visits 1 and three). Important clinical differences were observed for the symptom score (18.8), activities score (5.2) and impact score (14.3). The majority of participants (80%) reported they would be willing to undergo a new intensive care unit admission. Conclusion Despite the disease severity, there was a significant clinical, functional and quality of life improvement at the end of the third month. Most patients would be willing to undergo a new intensive care unit admission. PMID:28444072

Optical Coherence Tomography Accurately Measures Corneal Power Change From Laser Refractive Surgery

PubMed Central

McNabb, Ryan P.; Farsiu, Sina; Stinnett, Sandra S.; Izatt, Joseph A.; Kuo, Anthony N.

2014-01-01

Purpose To determine the ability of motion corrected optical coherence tomography (OCT) to measure the corneal refractive power change due to laser in situ keratomileusis (LASIK). Design Evaluation of a diagnostic test or technology in a cohort. Subjects 70 eyes from 37 subjects undergoing LASIK were measured preoperatively. 39 eyes from 22 subjects were measured postoperatively and completed the study. Methods Consecutive patients undergoing LASIK at the Duke Eye Center who consented to participate were imaged with Placido-ring topography, Scheimpflug photography and OCT on the day of their surgery. Patients were then reimaged with the same imaging systems at the post-operative month 3 visit. Change in pre- to post-operative corneal refractive power as measured by each of the imaging modalities was compared to the pre- to post-operative change in manifest refraction using t-test with generalized estimating equations. Main Outcome Measures Corneal refractive power change due to LASIK as measured by Placido-ring topography, Scheimpflug Photography, and OCT compared to the manifest refraction change vertexed to the corneal plane. The change in manifest refraction should correspond to the change in the corneal refractive power from LASIK and was considered the reference measurement. Results In 22 returning post-LASIK individuals (39 eyes), we found no significant difference between the clinically measured pre to post LASIK change in manifest refraction and both Scheimpflug photography (p = 0.714) and OCT (p = 0.216). In contrast, keratometry values from Placido-ring topography were found to be significantly different from the measured refractive change (p < 0.001). Additionally, of the three imaging modalities, OCT recorded the smallest mean absolute difference from the reference measurement with the least amount of variability. Conclusion Motion corrected OCT more accurately measures the change in corneal refractive power due to laser refractive surgery than currently available clinical devices. By offering accurate corneal refractive power measurements in normal and surgically modified subjects, OCT offers a compelling alternative to current clinical devices for determining corneal refractive power. PMID:25487424

Magnesium Sulfate Reduced Opioid Consumption in Obese Patients Undergoing Sleeve Gastrectomy: a Prospective, Randomized Clinical Trial.

PubMed

Kizilcik, Nurcan; Koner, Ozge

2018-05-12

The purpose of the study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation. A prospective, randomized, placebo-controlled clinical study. University hospital. Eighty patients undergoing sleeve gastrectomy. Visual analog scale for the evaluation of pain, sedation score, mean arterial pressure, heart rate, and total analgesic consumption was recorded. Serum magnesium levels were determined before the operation, at the end of the operation, and at 24 h. There were no significant differences between the groups with respect to demographics, and sedation scores. Cumulative morphine consumption and pain scores were found to be higher in the control group than the magnesium group. Perioperative use of magnesium sulfate reduced postoperative pain and opioid consumption in obese patients undergoing sleeve gastrectomy operations.

The Laboratory’s Role in Opioid Pain Medication Monitoring

PubMed Central

2012-01-01

Opioid analgesics are the most potent pain medications therefore they are often used for the treatment of chronic malignant and non-malignant pain. Their strong addictive potential requires close monitoring of patients on opioid therapy for possible non-compliance with prescriptions, for drug diversion, and for proof of avoidance of non-prescribed or illicit opioids. Monitoring can be performed by urine drug screens or qualitative or quantitative drug confirmation assays. Natural, semi-synthetic and synthetic opioids have dissimilar chemical structures and they undergo extensive metabolism. Phase one metabolic reactions of opioids can produce other opioids with similar structures to other, non-prescribed medications. Only detailed and concurrent analysis of parent drugs and metabolites can provide accurate clinical information regarding patient compliance. Traditional immunoassays, often used for urine drug screening, react with only a small number of opioids or only with a single medication and they exhibit variable cross reactivity with their phase two metabolites. Additionally the limit of detection of these immunoassays may not be sufficient for medical purposes, therefore clinical interpretation of immunoassay test results can be challenging. Recently liquid chromatography, mass spectrometry (LCMSMS) based assays have been adapted by many clinical laboratories. These LCMSMS tests can provide information about the presence of several opioids and their metabolites in a single sample at clinically meaningful detection limits, allowing accurate assessment of patient compliance. This review article will investigate in details the various opioids, their metabolism and the challenges the testing laboratories and ordering clinicians face. PMID:27683413

Factors influencing behavioral intention to undergo Papanicolaou testing in early adulthood: Comparison of Japanese and Korean women.

PubMed

Kang, Kyung-Ah; Kim, Shin-Jeong; Kaneko, Noriyo

2017-12-01

In this study, we identified the factors influencing behavioral intention to undergo Papanicolaou testing among Japanese and Korean women in early adulthood. Their behavioral intentions were compared in this cross-sectional descriptive study. In total, 887 women (Japanese = 498, Korean = 389) aged 20-39 years participated in this study. Using a self-report questionnaire, knowledge, attitudes, subjective norm, perceived behavioral control, and behavioral intention were surveyed. There were significant differences between Japanese and Korean women's scores on all main variables. For Japanese women, all the variables moderately correlated with behavioral intention. In comparison, for Korean women, all independent variables, except for knowledge, moderately correlated with behavioral intention. Through a multiple regression analysis, age, undergoing Papanicolaou testing, attitudes, subjective norm, and perceived behavioral control were identified as significant predictors of behavioral intention among Japanese women. Among Korean women, job status, undergoing a Papanicolaou test, attitudes, subjective norm, and perceived behavioral control were demonstrated as significant predictors of behavioral intention. Health professionals should consider these factors to encourage Papanicolaou testing in women in early adulthood. © 2017 John Wiley & Sons Australia, Ltd.

Intrinsic platelet reactivity before start with clopidogrel as predictor for on-clopidogrel platelet function and long-term clinical outcome.

PubMed

Hochholzer, Willibald; Valina, Christian M; Bömicke, Timo; Amann, Michael; Stratz, Christian; Nührenberg, Thomas; Trenk, Dietmar; Neumann, Franz-Josef

2015-07-01

High on-clopidogrel platelet reactivity is associated with worse clinical outcome. Previous data suggest that intrinsic platelet reactivity before initiation of clopidogrel contributes significantly to on-clopidogrel platelet reactivity. It is unknown whether intrinsic reactivity can sufficiently predict on-clopidogrel reactivity and therefore identify patients with insufficient response to clopidogrel before initiation of treatment and at risk for worse clinical outcome. This analysis included 765 consecutive patients undergoing elective coronary stent implantation. Platelet reactivity was assessed by light transmission aggregometry (5 µM ADP) before administration of clopidogrel 600mg and after intake of first maintenance dose of clopidogrel on day 1 following coronary stenting. Patients were followed for up to seven years. The combined primary endpoint was death of any cause or non-fatal myocardial infarction. Intrinsic and on-clopidogrel platelet reactivity were significant correlated (r=0.31; p < 0.001). Among all tested clinical and genetic factors including the cytochrome P450 2C19*2 polymorphism, intrinsic platelet reactivity was the strongest predictor for on-clopidogrel platelet reactivity. However, intrinsic platelet reactivity could only explain 8 % of variability of on-clopidogrel platelet function. Only on-treatment platelet reactivity was predictive for long-term clinical outcome (HR 1.47, 95 % CI 1.05-2.05; p = 0.02) whereas intrinsic platelet reactivity was not (HR 1.03, 95 % CI 0.74-1.43; p = 0.86). In conclusion, intrinsic platelet reactivity before initiation of clopidogrel is the strongest predictor of early on-clopidogrel platelet reactivity but can only explain a minor proportion of its variability and is not significantly associated with clinical outcome. Thus, baseline testing cannot substitute on-clopidogrel platelet function testing.

A theory-based decision aid for patients with cancer: results of feasibility and acceptability testing of DecisionKEYS for cancer.

PubMed

Hollen, Patricia J; Gralla, Richard J; Jones, Randy A; Thomas, Christopher Y; Brenin, David R; Weiss, Geoffrey R; Schroen, Anneke T; Petroni, Gina R

2013-03-01

Appropriate utilization of treatment is a goal for all patients undergoing cancer treatment. Proper treatment maximizes benefit and limits exposure to unnecessary measures. This report describes findings of the feasibility and acceptability of implementing a short, clinic-based decision aid and presents an in-depth clinical profile of the participants. This descriptive study used a prospective, quantitative approach to obtain the feasibility and acceptability of a decision aid (DecisionKEYS for Balancing Choices) for use in clinical settings. It combined results of trials of patients with three different common malignancies. All groups used the same decision aid series. Participants included 80 patients with solid tumors (22 with newly diagnosed breast cancer, 19 with advanced prostate cancer, and 39 with advanced lung cancer) and their 80 supporters as well as their physicians and nurses, for a total of 160 participants and 10 health professionals. The decision aid was highly acceptable to patient and supporter participants in all diagnostic groups. It was feasible for use in clinic settings; the overall value was rated highly. Of six physicians, all found the interactive format with the help of the nurse as feasible and acceptable. Nurses also rated the decision aid favorably. This intervention provides the opportunity to enhance decision making about cancer treatment and warrants further study including larger and more diverse groups. Strengths of the study included a theoretical grounding, feasibility testing of a practical clinic-based intervention, and summative evaluation of acceptability of the intervention by patient and supporter pairs. Further research also is needed to test the effectiveness of the decision aid in diverse clinical settings and to determine if this intervention can decrease overall costs.

Development of Validated Computer-based Preoperative Predictive Model for Proximal Junction Failure (PJF) or Clinically Significant PJK With 86% Accuracy Based on 510 ASD Patients With 2-year Follow-up.

PubMed

Scheer, Justin K; Osorio, Joseph A; Smith, Justin S; Schwab, Frank; Lafage, Virginie; Hart, Robert A; Bess, Shay; Line, Breton; Diebo, Bassel G; Protopsaltis, Themistocles S; Jain, Amit; Ailon, Tamir; Burton, Douglas C; Shaffrey, Christopher I; Klineberg, Eric; Ames, Christopher P

2016-11-15

A retrospective review of large, multicenter adult spinal deformity (ASD) database. The aim of this study was to build a model based on baseline demographic, radiographic, and surgical factors that can predict clinically significant proximal junctional kyphosis (PJK) and proximal junctional failure (PJF). PJF and PJK are significant complications and it remains unclear what are the specific drivers behind the development of either. There exists no predictive model that could potentially aid in the clinical decision making for adult patients undergoing deformity correction. Inclusion criteria: age ≥18 years, ASD, at least four levels fused. Variables included in the model were demographics, primary/revision, use of three-column osteotomy, upper-most instrumented vertebra (UIV)/lower-most instrumented vertebra (LIV) levels and UIV implant type (screw, hooks), number of levels fused, and baseline sagittal radiographs [pelvic tilt (PT), pelvic incidence and lumbar lordosis (PI-LL), thoracic kyphosis (TK), and sagittal vertical axis (SVA)]. PJK was defined as an increase from baseline of proximal junctional angle ≥20° with concomitant deterioration of at least one SRS-Schwab sagittal modifier grade from 6 weeks postop. PJF was defined as requiring revision for PJK. An ensemble of decision trees were constructed using the C5.0 algorithm with five different bootstrapped models, and internally validated via a 70 : 30 data split for training and testing. Accuracy and the area under a receiver operator characteristic curve (AUC) were calculated. Five hundred ten patients were included, with 357 for model training and 153 as testing targets (PJF: 37, PJK: 102). The overall model accuracy was 86.3% with an AUC of 0.89 indicating a good model fit. The seven strongest (importance ≥0.95) predictors were age, LIV, pre-operative SVA, UIV implant type, UIV, pre-operative PT, and pre-operative PI-LL. A successful model (86% accuracy, 0.89 AUC) was built predicting either PJF or clinically significant PJK. This model can set the groundwork for preop point of care decision making, risk stratification, and need for prophylactic strategies for patients undergoing ASD surgery. 3.

SheppHeartCABG trial—comprehensive early rehabilitation after coronary artery bypass grafting: a protocol for a randomised clinical trial

PubMed Central

Moons, Philip; Hansen, Niels Viggo; La Cour, Søren; Olsen, Peter Skov; Gluud, Christian; Winkel, Per; Lindschou, Jane; Thygesen, Lau Caspar; Egerod, Ingrid; Berg, Selina Kikkenborg

2017-01-01

Introduction Patients undergoing coronary artery bypass graft surgery often experience a range of symptoms. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation have a positive physiological and psychological effect in early outpatient rehabilitation. The SheppHeartCABG trial will investigate the effect of early comprehensive rehabilitation in early phase rehabilitation versus usual care. The aim of this paper is to present the protocol for the SheppHeartCABG trial. Methods/analysis SheppHeartCABG is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, employing 1:1 central randomisation to rehabilitation plus usual care versus usual care alone. On the basis of a sample size calculation, 326 patients undergoing coronary artery bypass grafting will be included from two clinical sites. All patients receive usual care and patients allocated to the experimental intervention follow 4 weeks rehabilitation consisting of an exercise programme, psycho-educative consultations and a compact mindfulness programme. The primary outcome is physical function measured by the 6-min walk test. The secondary outcomes are mental health and physical activity measured by the Medical Outcome Study Short Form (SF-12), anxiety and depression measured by the Hospital Anxiety and Depression Scale questionnaire, physical, emotional and global scores by the HeartQoL questionnaire, sleep measured by the Pittsburgh Sleep Quality Index, pain measured by the Örebro Musculoskeletal Screening Questionnaire and muscle endurance measured by the sit-to-stand test. A number of explorative analyses will also be conducted. Ethics and dissemination SheppHeartCABG is approved by the regional ethics committee (no. H-4-2014-109) and the Danish Data Protection Agency (no. 30-1309) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form. Positive, neutral and negative results of the trial will be submitted to international peer-reviewed journals. Furthermore, results will be presented at national and international conferences relevant to the subject fields. Trial registration number NCT02290262; pre-results. PMID:28096255

Vitamin D deficiency and pregnancy rates in women undergoing single embryo, blastocyst stage, transfer (SET) for IVF/ICSI.

PubMed

Polyzos, Nikolaos P; Anckaert, Ellen; Guzman, Luis; Schiettecatte, Johan; Van Landuyt, Lisbet; Camus, Michel; Smitz, Johan; Tournaye, Herman

2014-09-01

What is the influence of vitamin D deficiency on pregnancy rates among women undergoing IVF/ICSI and Day 5 (blastocyst stage) single embryo transfer (SET)? Vitamin D deficiency results in significantly lower pregnancy rates in women undergoing single blastocyst transfer. Preliminary experiments have identified the presence of vitamin D receptors in the female reproductive system. However, results regarding the effect of vitamin D deficiency on clinical outcomes are conflicting. None of the previous studies adopted a SET strategy. Serum vitamin D concentration was measured retrospectively in patients who underwent SET on Day 5. Overall 368 consecutive infertile women treated within a period of 15 months were included in the study. All patients underwent ovarian stimulation for IVF/ICSI and Day 5 SET. Serum samples were obtained 7 days prior to embryo transfer and stored frozen at -20°C. Samples were collectively analyzed for their 25-OH vitamin D content. Vitamin D deficiency was defined as serum 25-OH vitamin D levels <20 ng/ml in accordance with the Institute of Medicine and the Endocrine Society clinical practice guidelines. Clinical pregnancy rates were significantly lower in women with vitamin D deficiency compared with those with higher vitamin D values (41 versus 54%, P = 0.015).Logistic regression analysis was performed to identify whether vitamin D deficiency is independently associated with clinical pregnancy rates after controlling for 16 potential confounding factors. According to our results vitamin D deficiency was independently associated with lower clinical pregnancy rates, odds ratios [ORs (95% confidence interval (CI) 0.61 (0.39-0.95)] for vitamin D deficiency (deficient versus non-deficient women), P = 0.030. Finally, even when restricting our analysis to women undergoing elective SET (274 patients), vitamin D deficiency was again independently associated with pregnancy rates [OR (95% CI) 0.56 (0.33-0.93), P = 0.024]. Our results refer only to patients undergoing Day 5 SET. Although vitamin D deficiency appears to compromise pregnancy rates in this population, no guidance can be provided regarding a potential relationship between vitamin D deficiency and ovarian reserve or response to ovarian stimulation. Vitamin D deficiency impairs pregnancy rates in women undergoing single blastocyst transfer. Future prospective confirmatory studies are needed to validate our results and examine the exact underlying mechanism by which vitamin D levels may impair pregnancy rates in infertile women undergoing IVF/ICSI. None declared. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Surrounded by work platforms, the full-scale Orion AFT crew module (center) is undergoing preparations for the first flight test of Orion's launch abort system.

NASA Image and Video Library

2008-05-20

Surrounded by work platforms, NASA's first full-scale Orion abort flight test (AFT) crew module (center) is undergoing preparations at the NASA Dryden Flight Research Center in California for the first flight test of Orion's launch abort system. To the left is a space shuttle orbiter purge vehicle sharing the hangar.

A new rapid quantitative test for fecal calprotectin predicts endoscopic activity in ulcerative colitis.

PubMed

Lobatón, Triana; Rodríguez-Moranta, Francisco; Lopez, Alicia; Sánchez, Elena; Rodríguez-Alonso, Lorena; Guardiola, Jordi

2013-04-01

Fecal calprotectin (FC) determined by the enzyme-linked immunosorbent assay (ELISA) test has been proposed as a promising biomarker of endoscopic activity in ulcerative colitis (UC). However, data on its accuracy in predicting endoscopic activity is scarce. Besides, FC determined by the quantitative-point-of-care test (FC-QPOCT) that provides rapid and individual results could optimize its use in clinical practice. The aims of our study were to evaluate the ability of FC to predict endoscopic activity according to the Mayo score in patients with UC when determined by FC-QPOCT and to compare it with the ELISA test (FC-ELISA). FC was determined simultaneously by FC-ELISA and FC-QPOCT in patients with UC undergoing colonoscopy. Clinical disease activity and endoscopy were assessed according to the Mayo score. Blood tests were taken to analyze serological biomarkers. A total of 146 colonoscopies were performed on 123 patients with UC. FC-QPOCT correlated more closely with the Mayo endoscopic subscore (Spearman's correlation coefficient rank r = 0.727, P < 0.001) than clinical activity (r = 0.636, P < 0.001), platelets (r = 0.381, P < 0.001), leucocytes (r = 0.300, P < 0.001), and C-reactive protein (r = 0.291, P = 0.002). The prediction of "endoscopic remission" (Mayo endoscopic subscore ≤1) with FC-QPOCT (280 µg/g) and FC-ELISA (250 µg/g) presented an area under the curve of 0.906 and 0.924, respectively. The interclass correlation index between both tests was 0.904 (95% confidence interval, 0.864-0.932; P < 0.001). FC determined by QPOCT was an accurate surrogate marker of "endoscopic remission" in UC and presented a good correlation with the FC-ELISA test.

Failure to account for practice effects leads to clinical misinterpretation of cognitive outcome following carotid endarterectomy.

PubMed

Marley, Christopher J; Sinnott, Andrew; Hall, Judith E; Morris-Stiff, Gareth; Woodsford, Paul V; Lewis, Michael H; Bailey, Damian M

2017-06-01

Carotid endarterectomy (CEA) is a surgical procedure to remove stenotic atherosclerotic plaque from the origin of the carotid artery to reduce the risk of major stroke. Its impact on postoperative cognitive function (POCF) remains controversial; complicated, in part, by a traditional failure to account for practice effects incurred during consecutive psychometric testing. To address this for the first time, we performed psychometric testing (learning and memory, working memory, attention and information processing, and visuomotor coordination) in 15 male patients aged 68  ±  8 years with symptomatic carotid stenosis the day before and 24 h following elective CEA (two consecutive tests, 48 h apart). Multiple baselining was also performed in a separate cohort of 13 educationally, anthropometrically and age-matched controls (63  ±  9 years) not undergoing revascularization at identical time points with additional measures performed over a further 96 h (four consecutive tests, each 48 h apart). A single consecutive test in the control group resulted in progressive improvements in learning and memory, working memory, and attention and information ( P  <   0.05 vs. Test 1), with three tests required before cognitive performance stabilized. Following correction for practice effects in the patient group, CEA was associated with a deterioration rather than an improvement in learning and memory as originally observed ( P  <   0.05). These findings highlight the potential for the clinical misinterpretation of POCF unless practice effects are taken into account and provide practical recommendations for implementation within the clinical setting. © 2017 The Authors. Physiological Reports published by Wiley Periodicals, Inc. on behalf of The Physiological Society and the American Physiological Society.

Validity and Responsiveness of the Two-Minute Walk Test for Measuring Functional Recovery After Total Knee Arthroplasty.

PubMed

Unnanuntana, Aasis; Ruangsomboon, Pakpoom; Keesukpunt, Worawut

2018-06-01

The 2-minute walk test (2mwt) is a performance-based test that evaluates functional recovery after total knee arthroplasty (TKA). This study evaluated its validity compared with the modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Knee Score (OKS), modified Knee Score, Numerical Pain Rating Scale, and Timed Up and Go test, and its responsiveness in assessing functional recovery in TKA patients. This prospective cohort study included 162 patients undergoing primary TKA between 2013 and 2015. We used patient-reported outcome measures (modified WOMAC, OKS, modified Knee Score, Numerical Pain Rating Scale) and performance-based tests (2mwt and Timed Up and Go test) at baseline and 3, 6, and 12 months postoperatively. The construct validity of 2mwt was determined between the 2mwt distances walked and other outcome measurements. To assess responsiveness, effect size and standardized response mean were analyzed. Minimal clinically important difference of 2mwt at 12 months after TKA was also calculated. All outcome measurements improved significantly from baseline to 3, 6, and 12 months postoperatively. Bivariate analysis revealed mild to moderate associations between the 2mwt and modified WOMAC function subscales, and moderate to strong associations with OKS. Mild to moderate correlations were found for pain and stiffness between 2mwt and other outcome measurements. The effect size and standardized response mean at 12 months were large, with a minimal clinically important difference of 12.7 m. 2mwt is a validated performance-based test with responsiveness properties. Being simple and easy to perform, it can be used routinely in clinical practice to evaluate functional recovery after TKA. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Persistent Atrial Fibrillation Ablation in Females: Insight from the MAGIC-AF Trial.

PubMed

Singh, Sheldon M; D'Avila, Andre; Aryana, Arash; Kim, Young-Hoon; Mangrum, J Michael; Michaud, Gregory F; Dukkipati, Srinivas R; Heist, E Kevin; Barrett, Conor D; Thorpe, Kevin E; Reddy, Vivek Y

2016-07-27

Atrial fibrillation (AF) ablation is less frequently performed in women when compared to men. There are conflicting data on the safety and efficacy of AF ablation in women. The objective of this study was to compare the clinical characteristics and outcomes in a contemporary cohort of men and women undergoing persistent AF ablation procedures. A total of 182 men and 53 women undergoing a first-ever persistent AF catheter ablation procedure in The Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation (MAGIC-AF) trial were evaluated. Clinical and procedural characteristics were compared between each gender. The primary efficacy endpoint was the 1-year single procedure freedom from atrial arrhythmia off anti-arrhythmic drugs. Women undergoing catheter ablation procedures were older than men (P < 0.001). The duration of AF and associated co-morbidities were similar between both genders. Single procedure drug-free atrial arrhythmia recurrence occurred in 53% of the cohort with no difference based on gender (men = 54%, women = 53%; P = 1.0). Procedural (P = 0.04), fluoroscopic (P = 0.02), and ablation times (P = 0.003) were shorter in women compared to men. Periprocedural complications and postablation improvement in quality of life were similar between men and women. Women undergoing a first-ever persistent AF ablation procedure were older but had similar clinical outcomes and complications when compared with men. © 2016 Wiley Periodicals, Inc.

CLINICAL DEMOGRAPHIC CHARACTERISTICS OF TOTAL KNEE ARTHROPLASTY IN A UNIVERSITY HOSPITAL

PubMed Central

Souza, José Miguel Francisco da Silva; Ferreira, Ricardo dos Santos; de Lima, Alexandre José Pereira; de Sá, Airton César Pereira; de Albuquerque, Paulo Cezar Vidal Carneiro

2016-01-01

ABSTRACT Objective: To assess socio-demographic characteristics of patients undergoing total knee arthroplasty (TKA) in a public university hospital, evaluating the outcome infection and associated factors. Method: A retrospective study was carried out with 78 patients undergoing TKA, from 2013 to 2014. The socio-demographic and clinical characteristics of the patients were collected. Comparison between infected and non-infected patients was performed to find out which variables were possibly associated to this complication. Result: Of 81 arthroplasties performed, patients were older (mean age 64 years), women (79%), with primary osteoarthritis as main etiology (87.6%) and most had comorbidities (82.7%). Infection occurred in 16% of patients, and this outcome associated with age older than 65 years (p=0.023) and the occurrence of deep vein thrombosis (p=0.027). Conclusion: Patients undergoing TKA are mostly elderly women with primary osteoarthritis in the knee and comorbidities who developed infection in 16% of cases. More studies need to be conducted aimed at creating specific protocols in order to improve the quality of clinical practice. Level of Evidence III, Retrospective Comparative Study. PMID:28924354

Translation and Validation of the Knee Society Score - KSS for Brazilian Portuguese

PubMed Central

Silva, Adriana Lucia Pastore e; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; da Silva, Tânia Fernanda Cardoso; Pécora, José Ricardo; Croci, Alberto Tesconi

2012-01-01

Objective To translate, culturally adapt and validate the "Knee Society Score"(KSS) for the Portuguese language and determine its measurement properties, reproducibility and validity. Methods We analyzed 70 patients of both sexes, aged between 55 and 85 years, in a cross-sectional clinical trial, with diagnosis of primary osteoarthritis ,undergoing total knee arthroplasty surgery. We assessed the patients with the English version of the KSS questionnaire and after 30 minutes with the Portuguese version of the KSS questionnaire, done by a different evaluator. All the patients were assessed preoperatively, and again at three, and six months postoperatively. Results There was no statistical difference, using Cronbach's alpha index and the Bland-Altman graphical analysis, for the knees core during the preoperative period (p =1), and at three months (p =0.991) and six months postoperatively (p =0.985). There was no statistical difference for knee function score for all three periods (p =1.0). Conclusion The Brazilian version of the Knee Society Score is easy to apply, as well providing as a valid and reliable instrument for measuring the knee score and function of Brazilian patients undergoing TKA. Level of Evidence: Level I - Diagnostic Studies- Investigating a Diagnostic Test- Testing of previously developed diagnostic criteria on consecutive patients (with universally applied 'gold' reference standard). PMID:24453576

Screening adherence and cancer risk perceptions in colorectal cancer survivors with Lynch-like syndrome.

PubMed

Katz, L H; Burton-Chase, A M; Advani, S; Fellman, B; Polivka, K M; Yuan, Y; Lynch, P M; Peterson, S K

2016-03-01

Cancer screening recommendations for patients with Lynch-like syndrome (LLS) are not well defined. We evaluated adherence to Lynch syndrome (LS) screening recommendations, cancer risk perceptions, and communication within the families among colorectal cancer (CRC) survivors with LLS. Thirty-four participants with LLS completed a questionnaire about risk perception, adherence to LS screening recommendations, and communication with relatives. Clinical data were obtained from medical records. Most participants (76%) believed they should undergo colonoscopy every 1-2 years. Only 41% correctly interpreted their genetic tests as uninformative negative or as variant of unknown significance for LS. Less than half had had an upper gastrointestinal endoscopy for screening purpose. Among female participants, 86% had been screened for endometrial cancer (EC) and 71% for ovarian cancer. Most participants had informed relatives about the CRC diagnosis and advised them to undergo CRC screening, but only 50% advised female relatives to be screened for EC and only one-third advised relatives to have genetic counseling. Most CRC survivors with LLS follow the same cancer screening recommended for LS patients but do not understand the meaning of LLS. Greater care must be devoted to communicating the implications of nondiagnostic germline mutation testing among patients with LLS. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Screening adherence and cancer risk perceptions in colorectal cancer survivors with Lynch-like syndrome

PubMed Central

Katz, Lior H.; Burton-Chase, Allison M.; Advani, Shailesh; Fellman, Bryan; Polivka, Katrina M.; Yuan, Ying; Lynch, Patrick M.; Peterson, Susan K.

2016-01-01

Background Cancer screening recommendations for patients with Lynch-like syndrome (LLS) are not well defined. We evaluated adherence to Lynch syndrome (LS) screening recommendations, cancer risk perceptions, and communication within the families among colorectal cancer (CRC) survivors with LLS. Methods Thirty-four participants with LLS completed a questionnaire about risk perception, adherence to LS screening recommendations, and communication with relatives. Clinical data were obtained from medical records. Results Most participants (76%) believed they should undergo colonoscopy every 1-2 years. Only 41% correctly interpreted their genetic tests as uninformative negative or as variant of unknown significance for LS. Less than half had had an upper GI endoscopy for screening purpose. Among female participants, 86% had been screened for endometrial cancer and 71% for ovarian cancer. Most participants had informed relatives about the CRC diagnosis and advised them to undergo CRC screening, but only 50% advised female relatives to be screened for endometrial cancer and only one-third advised relatives to have genetic counseling. Conclusions Most CRC survivors with LLS follow the same cancer screening recommended for LS patients but do not understand the meaning of LLS. Greater care must be devoted to communicating the implications of non-diagnostic germline mutation testing among patients with LLS. PMID:26272410

Revisioning the Clinical Relationship: Heinz Kohut and the Viewpoint of Self-Psychology.

ERIC Educational Resources Information Center

Masek, Robert J.

Psychoanalysis is undergoing rapid and remarkable changes in its basic metapsychology, theoretical reflections, and concrete, clinical interventions. Through self-psychology, Heinz Kohut's alternative views on the clinical relationship have contributed to this restructuring of psychoanalysis. Traditionally, mainstream psychoanalysis has viewed the…

Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

PubMed Central

Huang, Hongyun; Young, Wise; Chen, Lin; Feng, Shiqing; Zoubi, Ziad M. Al; Sharma, Hari Shanker; Saberi, Hooshang; Moviglia, Gustavo A.; He, Xijing; Muresanu, Dafin F.; Sharma, Alok; Otom, Ali; Andrews, Russell J.; Al-Zoubi, Adeeb; Bryukhovetskiy, Andrey S.; Chernykh, Elena R.; Domańska-Janik, Krystyna; Jafar, Emad; Johnson, W. Eustace; Li, Ying; Li, Daqing; Luan, Zuo; Mao, Gengsheng; Shetty, Ashok K.; Siniscalco, Dario; Skaper, Stephen; Sun, Tiansheng; Wang, Yunliang; Wiklund, Lars; Xue, Qun; You, Si-Wei; Zheng, Zuncheng; Dimitrijevic, Milan R.; Masri, W. S. El; Sanberg, Paul R.; Xu, Qunyuan; Luan, Guoming; Chopp, Michael; Cho, Kyoung-Suok; Zhou, Xin-Fu; Wu, Ping; Liu, Kai; Mobasheri, Hamid; Ohtori, Seiji; Tanaka, Hiroyuki; Han, Fabin; Feng, Yaping; Zhang, Shaocheng; Lu, Yingjie; Zhang, Zhicheng; Rao, Yaojian; Tang, Zhouping; Xi, Haitao; Wu, Liang; Shen, Shunji; Xue, Mengzhou; Xiang, Guanghong; Guo, Xiaoling; Yang, Xiaofeng; Hao, Yujun; Hu, Yong; Li, Jinfeng; AO, Qiang; Wang, Bin; Zhang, Zhiwen; Lu, Ming; Li, Tong

2018-01-01

Cell therapy has been shown to be a key clinical therapeutic option for central nervous system diseases or damage. Standardization of clinical cell therapy procedures is an important task for professional associations devoted to cell therapy. The Chinese Branch of the International Association of Neurorestoratology (IANR) completed the first set of guidelines governing the clinical application of neurorestoration in 2011. The IANR and the Chinese Association of Neurorestoratology (CANR) collaborated to propose the current version “Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)”. The IANR council board members and CANR committee members approved this proposal on September 1, 2016, and recommend it to clinical practitioners of cellular therapy. These guidelines include items of cell type nomenclature, cell quality control, minimal suggested cell doses, patient-informed consent, indications for undergoing cell therapy, contraindications for undergoing cell therapy, documentation of procedure and therapy, safety evaluation, efficacy evaluation, policy of repeated treatments, do not charge patients for unproven therapies, basic principles of cell therapy, and publishing responsibility. PMID:29637817

Cost-effectiveness analysis of a postoperative clinical care pathway in head and neck surgery with microvascular reconstruction.

PubMed

Dautremont, Jonathan F; Rudmik, Luke R; Yeung, Justin; Asante, Tiffany; Nakoneshny, Steve C; Hoy, Monica; Lui, Amanda; Chandarana, Shamir P; Matthews, Thomas W; Schrag, Christiaan; Dort, Joseph C

2013-12-19

The objective of this study is to evaluate the cost-effectiveness of a postoperative clinical care pathway for patients undergoing major head and neck oncologic surgery with microvascular reconstruction. This is a comparative trial of a prospective treatment group managed on a postoperative clinical care pathway and a historical group managed prior to pathway implementation. Effectiveness outcomes evaluated were total hospital days, return to OR, readmission to ICU and rate of pulmonary complications. Costing perspective was from the government payer. 118 patients were included in the study. All outcomes demonstrated that the postoperative pathway group was both more effective and less costly, and is therefore a dominant clinical intervention. The overall mean pre- and post-pathway costs are $22,733 and $16,564 per patient, respectively. The incremental cost reduction associated with the postoperative pathway was $6,169 per patient. Implementing the postoperative clinical care pathway in patients undergoing head and neck oncologic surgery with reconstruction resulted in improved clinical outcomes and reduced costs.

Economic impact of clinical variability in preoperative testing for major outpatient surgery.

PubMed

Gil-Borrelli, Christian Carlo; Agustí, Salomé; Pla, Rosa; Díaz-Redondo, Alicia; Zaballos, Matilde

2016-05-01

With the purpose of decreasing the existing variability in the criteria of preoperative evaluation and facilitating the clinical decision-making process, our hospital has a protocol of preoperative tests to use with ASA I and ASA II patients. The aim of the study was to calculate the economic impact caused by clinicians' non-adherence to the protocol for the anaesthesiological evaluation of ASA 1 and ASA II patients. A retrospective study of costs with a random sample of 353 patients that were seen in the consultation for Anesthesiology over a period of one year. Aspects related to the costs, patient's profiles and specialties were analysed, according to the degree of fulfillment of the protocol. The lack of adherence to the the protocol was 70%. 130 chest X-rays and 218 ECG were performed without indication. This generated an excess costs of 34 € per patient. Taking into account the expenses of both tests and the attended population undergoing ambulatory surgery during the one-year period, an excess spending for the hospital of between 69.164 € and 83.312 € was estimated. Clinical variability should be reduced and the creation of synergies between the different departments should be enhanced in order to adjust the request for unnecessary complementary tests to decrease health care and to improve the quality of patient care. Copyright © 2016 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

The Virtual Anemia Trial: An Assessment of Model-Based In Silico Clinical Trials of Anemia Treatment Algorithms in Patients With Hemodialysis.

PubMed

Fuertinger, Doris H; Topping, Alice; Kappel, Franz; Thijssen, Stephan; Kotanko, Peter

2018-04-01

In silico approaches have been proposed as a novel strategy to increase the repertoire of clinical trial designs. Realistic simulations of clinical trials can provide valuable information regarding safety and limitations of treatment protocols and have been shown to assist in the cost-effective planning of clinical studies. In this report, we present a blueprint for the stepwise integration of internal, external, and ecological validity considerations in virtual clinical trials (VCTs). We exemplify this approach in the context of a model-based in silico clinical trial aimed at anemia treatment in patients undergoing hemodialysis (HD). Hemoglobin levels and subsequent anemia treatment were simulated on a per patient level over the course of a year and compared to real-life clinical data of 79,426 patients undergoing HD. The novel strategies presented here, aimed to improve external and ecological validity of a VCT, significantly increased the predictive power of the discussed in silico trial. © 2018 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

A randomized controlled trial evaluating the effect of ethinyl estradiol during clomiphene citrate cycles among women with polycystic ovary syndrome.

PubMed

Moini, Ashraf; Ahmadi, Firoozeh; Jahangiri, Nadia; Ahmadi, Jila; Akhoond, Mohammad Reza

2015-11-01

To investigate the effects of low-dose ethinyl estradiol (EE) on the clinical pregnancy rate among women with polycystic ovary syndrome (PCOS) undergoing ovulation induction with clomiphene citrate (CC). Between March 12, 2011, and February 10, 2013, a randomized, double-blind, placebo-controlled trial was conducted at the Royan Institute Research Center, Tehran, Iran, among women with PCOS who were aged 25-30 years, were undergoing their first intrauterine insemination cycle, and had a history (≥2 years) of infertility, oligomenorrhea, or amenorrhea. Participants were randomly allocated to receive EE (0.05 mg daily for 5 days) or placebo, co-administered with CC cycles (100 mg daily for 5 days). The primary outcome was clinical pregnancy rate. Analyses were per protocol: patients who discontinued the intervention were excluded. Analyses included 45 women who received CC and EE, and 50 women who received CC and placebo. The number of women who achieved a clinical pregnancy was higher among participants who received CC and EE (13 [29%]) than among those in the control group (5 [10%]; P =0 .02). No adverse effects of EE were reported. The combination of CC and EE seems to increase the clinical pregnancy rate among women with PCOS undergoing intrauterine insemination. ClinicalTrials.gov:NCT01219101. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Willingness to undergo HIV testing in the Kintampo districts of Ghana.

PubMed

Abokyi, L V; Zandoh, C; Mahama, E; Sulemana, A; Adda, R; Amenga-Etego, S; Baiden, F; Owusu-Agyei, S

2014-03-01

HIV testing is currently a major prevention intervention and remains an entry point to early treatment, care and support. Uptake is however low and alternative approaches are currently being adopted. An HIV module was incorporated into the routine survey of the Kintampo Health and Demographic Surveillance System (KHDSS) to assess the willingness of adults living in the Kintampo North and South districts to undergo HIV testing. The study was a descriptive cross-sectional household survey. Univariate and multivariate analysis were used to identify predictors of the willingness to undergo HIV testing. Respondents were community members aged 15 to 49 years and selected from randomly generated household listings from the KHDSS. A total of 11,604 respondents were interviewed, 10,982 (94.6%) of respondents had good general knowledge on HIV/AIDS. Among those with knowledge about HIV/AIDS, 10,819 (98.5%) indicated their willingness to get tested for HIV. Rural residents were more willing to undergo HIV testing than urban dwellers Odds ratio=1.42 (95% Confidence interval: 1.03, 1.96; P-value=0.031). Respondents with primary education were more likely to go for testing relative to those without any education OR=2.02 (95% CI: 0.87, 4.70; P-value=0.046). Expressed willingness to test for HIV is high in this population. Exploring community and population-based interventions to HIV testing and counseling could increase uptake of HIV testing services and should be considered. The underlying motivations need to be explored in order to translate willingness into actual testing.

Comparative investigation of the effectiveness of face-to-face verbal training and educational pamphlets on readiness of patients before undergoing non-emergency surgeries

PubMed Central

Noorian, Cobra; Aein, Fereshteh

2015-01-01

Background: The thought of having a surgery can be stressful for everyone. Providing the necessary information to the patient can help both the patient and the treatment team. This study was conducted to compare the effectiveness of face-to-face verbal training and educational pamphlets on the readiness of patients for undergoing non-emergency surgeries. Materials and Methods: The study was a before–after randomized clinical trial. 90 patients scheduled to undergo non-emergency surgery who referred to Shahrekord Ayatollah Kashani Hospital in 2013 were distributed randomly and gradually into two experimental groups (group of face-to-face verbal training and group of educational pamphlet) and one control group. Dependent variable of the study was pre-surgery readiness. Data analysis was carried out by using SPSS statistical software. Statistical analysis were analysis of variance (ANOVA) and correlation test. Results: Results showed that the mean scores of pre-surgery readiness in both interventional groups were significantly higher than that in the control group after the intervention (P < 0.05). However, there was no significant difference between the two experimental groups (P > 0.05). Conclusions: Each of the methods of face-to-face verbal education and using the pamphlet could be equally effective in improving the readiness of the patients undergoing surgery. Therefore, in environments where the health care providers are facing with the pressure of work and lack of sufficient time for face-to-face verbal training, suitable educational pamphlets can be used to provide the necessary information to patients and prepare them for surgery. PMID:26097859

Comparative investigation of the effectiveness of face-to-face verbal training and educational pamphlets on readiness of patients before undergoing non-emergency surgeries.

PubMed

Noorian, Cobra; Aein, Fereshteh

2015-01-01

The thought of having a surgery can be stressful for everyone. Providing the necessary information to the patient can help both the patient and the treatment team. This study was conducted to compare the effectiveness of face-to-face verbal training and educational pamphlets on the readiness of patients for undergoing non-emergency surgeries. The study was a before-after randomized clinical trial. 90 patients scheduled to undergo non-emergency surgery who referred to Shahrekord Ayatollah Kashani Hospital in 2013 were distributed randomly and gradually into two experimental groups (group of face-to-face verbal training and group of educational pamphlet) and one control group. Dependent variable of the study was pre-surgery readiness. Data analysis was carried out by using SPSS statistical software. Statistical analysis were analysis of variance (ANOVA) and correlation test. Results showed that the mean scores of pre-surgery readiness in both interventional groups were significantly higher than that in the control group after the intervention (P < 0.05). However, there was no significant difference between the two experimental groups (P > 0.05). Each of the methods of face-to-face verbal education and using the pamphlet could be equally effective in improving the readiness of the patients undergoing surgery. Therefore, in environments where the health care providers are facing with the pressure of work and lack of sufficient time for face-to-face verbal training, suitable educational pamphlets can be used to provide the necessary information to patients and prepare them for surgery.

Alfaxalone or ketamine-medetomidine in cats undergoing ovariohysterectomy: a comparison of intra-operative parameters and post-operative pain.

PubMed

Kalchofner Guerrero, Karin S; Reichler, Iris M; Schwarz, Andrea; Jud, Rahel S; Hässig, Michael; Bettschart-Wolfensberger, Regula

2014-11-01

To compare post-operative pain in cats after alfaxalone or ketamine- medetomidine anaesthesia for ovariohysterectomy (OHE) and physiologic parameters during and after surgery. Prospective 'blinded' randomized clinical study. Twenty-one healthy cats. Cats were assigned randomly into two groups: Group A, anaesthesia was induced and maintained with alfaxalone [5 mg kg(-1) intravenously (IV) followed by boli (2 mg kg(-1) IV); Group MK, induction with ketamine (5 mg kg(-1) IV) after medetomidine (30 μg kg(-1) intramuscularly (IM)], and maintenance with ketamine (2 mg kg(-1) IV). Meloxicam (0.2 mg kg(-1) IV) was administered after surgery. Basic physiological data were collected. At time T = -2, 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-operatively pain was assessed by three methods, a composite pain scale (CPS; 0-24 points), a visual analogue scale (VAS 0-100 mm), and a mechanical wound threshold (MWT) device. Butorphanol (0.2 mg kg(-1) IM) was administered if CPS was scored ≥13. Data were analyzed using a general linear model, Kruskal-Wallis analyses, Bonferroni-Dunn test, unpaired t-test and Fisher's exact test as relevant. Significance was set at p < 0.05. VASs were significantly higher at 0.5, 1, 2, 4, and 20 hours in group A; MWT values were significantly higher at 8 and 12 hours in group MK. Post-operative MWT decreased significantly compared to baseline in both groups. There was no difference in CPS at any time point. Five cats required rescue analgesia (four in A; one in MK). Anaesthesia with ketamine-medetomidine was found to provide better post-surgical analgesia than alfaxalone in cats undergoing OHE; however, primary hyperalgesia developed in both groups. Alfaxalone is suitable for induction and maintenance of anaesthesia in cats undergoing OHE, but administration of additional sedative and analgesic drugs is highly recommended. © 2014 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia.

Is knowledge translation adequate? A quality assurance study of staging investigations in early stage breast cancer patients.

PubMed

Han, Dolly; Hogeveen, Sophie; Sweet Goldstein, Miriam; George, Ralph; Brezden-Masley, Christine; Hoch, Jeffrey; Haq, Rashida; Simmons, Christine E

2012-02-01

After primary surgery, patients diagnosed with early stage breast cancer undergo radiological investigations based on pathologic stage of disease to rule out distant metastases. Published guidelines can aid clinicians in determining which tests are appropriate based on stage of disease. We wished to assess the consistency of radiological staging in an academic community oncology setting with standard guidelines and to determine the overall impact of non-adherence to these guidelines. A retrospective cohort study was conducted for new breast cancer patients seen at a single institution between January 2009 and April 2010. Patients were included if initial diagnosis and primary surgery was at this institution. Pathologic stage and radiological tests completed were recorded. A literature review was performed and the results were compared with those from this study to determine overall adherence rates. Subsequently, a cost analysis was performed to determine the financial impact at this centre. 231 patients met eligibility criteria for inclusion in this study. A large proportion of patients were over-staged with 129 patients (55%) undergoing unnecessary investigations according to guidelines. Specifically, 59% of stage I patients and 58% of stage II patients were over-investigated. Distant metastases at the time of diagnosis were found in three patients, all of whom had stage III disease (1.3%). The literature reviewed revealed similar non-adherence rates in other centres. The estimated cost of such non-adherence is in the range of $78 (CDN) per new early stage breast cancer patient seen at this centre. This oncology centre has a low adherence to practice guidelines for staging investigations in breast cancer patients, with 55% of patients undergoing unnecessary tests. Very few patients had metastases at diagnosis, and all had pathological stage III disease. Efforts may need to focus on improving knowledge translation across clinical oncology settings to increase guideline adherence.

Potential impact of amyloid imaging on diagnosis and intended management in patients with progressive cognitive decline.

PubMed

Grundman, Michael; Pontecorvo, Michael J; Salloway, Stephen P; Doraiswamy, P Murali; Fleisher, Adam S; Sadowsky, Carl H; Nair, Anil K; Siderowf, Andrew; Lu, Ming; Arora, Anupa K; Agbulos, Abigail; Flitter, Matthew L; Krautkramer, Michael J; Sarsour, Khaled; Skovronsky, Daniel M; Mintun, Mark A

2013-01-01

Florbetapir F18 has been approved by the Food and Drug Administration for in vivo assessment of amyloid pathology in patients undergoing evaluation for Alzheimer disease (AD). The aim of this study was to determine the impact of amyloid imaging on the diagnoses and management of patients undergoing evaluation for cognitive decline. Patients were recruited to participate at 19 clinical sites. The site physician provided a provisional diagnosis, an estimate of their diagnostic confidence, and their plan for diagnostic evaluation and management both before and after receiving the results from amyloid imaging with florbetapir F18. Analyses compared the frequency of AD and non-AD diagnoses, plans for ancillary testing, and intended patient management before and after florbetapir imaging. A total of 229 patients participated in the trial (113 amyloid positive, 116 amyloid negative). After receiving the results of the florbetapir scan, diagnosis changed in 125/229, or 54.6% [95% confidence intervals (CI), 48.1%-60.9%], of cases, and diagnostic confidence increased by an average of 21.6% (95% CI, 18.3%-24.8%). A total of 199/229 or 86.9% (95% CI, 81.9%-90.7%) of cases had at least 1 change in their management plan. Intended cholinesterase inhibitor or memantine treatment increased by 17.7% (95% CI, 11.8%-25.8%) of all cases with positive scans and decreased by 23.3% (95% CI, 16.5%-31.8%) of all those with negative scans. Among subjects who had not yet undergone a completed work up, planned brain structural imaging (computed tomographic/magnetic resonance imaging) decreased by 24.4% (95% CI, 17.5%-32.8%) and planned neuropsychological testing decreased by 32.8% (95% CI, 25.0%-41.6%). In summary, amyloid imaging results altered physician's diagnostic thinking, intended testing, and management of patients undergoing evaluation for cognitive decline.

Controlling motion sickness and spatial disorientation and enhancing vestibular rehabilitation with a user-worn see-through display.

PubMed

Krueger, Wesley W O

2011-01-01

An eyewear mounted visual display ("User-worn see-through display") projecting an artificial horizon aligned with the user's head and body position in space can prevent or lessen motion sickness in susceptible individuals when in a motion provocative environment as well as aid patients undergoing vestibular rehabilitation. In this project, a wearable display device, including software technology and hardware, was developed and a phase I feasibility study and phase II clinical trial for safety and efficacy were performed. Both phase I and phase II were prospective studies funded by the NIH. The phase II study used repeated measures for motion intolerant subjects and a randomized control group (display device/no display device) pre-posttest design for patients in vestibular rehabilitation. Following technology and display device development, 75 patients were evaluated by test and rating scales in the phase II study; 25 subjects with motion intolerance used the technology in the display device in provocative environments and completed subjective rating scales, whereas 50 patients were evaluated before and after vestibular rehabilitation (25 using the display device and 25 in a control group) using established test measures. All patients with motion intolerance rated the technology as helpful for nine symptoms assessed, and 96% rated the display device as simple and easy to use. Duration of symptoms significantly decreased with use of the technology displayed. In patients undergoing vestibular rehabilitation, there were no significant differences in amount of change from pre- to posttherapy on objective balance tests between display device users and controls. However, those using the technology required significantly fewer rehabilitation sessions to achieve those outcomes than the control group. A user-worn see-through display, utilizing a visual fixation target coupled with a stable artificial horizon and aligned with user movement, has demonstrated substantial benefit for individuals susceptible to motion intolerance and spatial disorientation and those undergoing vestibular rehabilitation. The technology developed has applications in any environment where motion sensitivity affects human performance.

Point-of-service, quantitative analysis of ascorbic acid in aqueous humor for evaluating anterior globe integrity

NASA Astrophysics Data System (ADS)

Gartia, Manas R.; Misra, Santosh K.; Ye, Mao; Schwartz-Duval, Aaron; Plucinski, Lisa; Zhou, Xiangfei; Kellner, David; Labriola, Leanne T.; Pan, Dipanjan

2015-11-01

Limited training, high cost, and low equipment mobility leads to inaccuracies in decision making and is concerning with serious ocular injuries such as suspected ruptured globe or post-operative infections. Here, we present a novel point-of-service (POS) quantitative ascorbic acid (AA) assay with use of the OcuCheck Biosensor. The present work describes the development and clinical testing of the paper-based biosensor that measures the changes in electrical resistance of the enzyme-plated interdigitated electrodes to quantify the level of AA present in ocular fluid. We have demonstrated the proof-of-concept of the biosensor testing 16 clinical samples collected from aqueous humor of patients undergoing therapeutic anterior chamber paracentesis. Comparing with gold standard colorimetric assay for AA concentration, OcuCheck showed accuracy of >80%, sensitivity of >88% and specificity of >71%. At present, there are no FDA-approved POS tests that can directly measures AA concentration levels in ocular fluid. We envisage that the device can be realized as a handheld, battery powered instrument that will have high impact on glaucoma care and point-of-care diagnostics of penetrating ocular globe injuries.

Point-of-service, quantitative analysis of ascorbic acid in aqueous humor for evaluating anterior globe integrity.

PubMed

Gartia, Manas R; Misra, Santosh K; Ye, Mao; Schwartz-Duval, Aaron; Plucinski, Lisa; Zhou, Xiangfei; Kellner, David; Labriola, Leanne T; Pan, Dipanjan

2015-11-03

Limited training, high cost, and low equipment mobility leads to inaccuracies in decision making and is concerning with serious ocular injuries such as suspected ruptured globe or post-operative infections. Here, we present a novel point-of-service (POS) quantitative ascorbic acid (AA) assay with use of the OcuCheck Biosensor. The present work describes the development and clinical testing of the paper-based biosensor that measures the changes in electrical resistance of the enzyme-plated interdigitated electrodes to quantify the level of AA present in ocular fluid. We have demonstrated the proof-of-concept of the biosensor testing 16 clinical samples collected from aqueous humor of patients undergoing therapeutic anterior chamber paracentesis. Comparing with gold standard colorimetric assay for AA concentration, OcuCheck showed accuracy of >80%, sensitivity of >88% and specificity of >71%. At present, there are no FDA-approved POS tests that can directly measures AA concentration levels in ocular fluid. We envisage that the device can be realized as a handheld, battery powered instrument that will have high impact on glaucoma care and point-of-care diagnostics of penetrating ocular globe injuries.

Point-of-service, quantitative analysis of ascorbic acid in aqueous humor for evaluating anterior globe integrity

PubMed Central

Gartia, Manas R.; Misra, Santosh K.; Ye, Mao; Schwartz-Duval, Aaron; Plucinski, Lisa; Zhou, Xiangfei; Kellner, David; Labriola, Leanne T.; Pan, Dipanjan

2015-01-01

Limited training, high cost, and low equipment mobility leads to inaccuracies in decision making and is concerning with serious ocular injuries such as suspected ruptured globe or post-operative infections. Here, we present a novel point-of-service (POS) quantitative ascorbic acid (AA) assay with use of the OcuCheck Biosensor. The present work describes the development and clinical testing of the paper-based biosensor that measures the changes in electrical resistance of the enzyme-plated interdigitated electrodes to quantify the level of AA present in ocular fluid. We have demonstrated the proof-of-concept of the biosensor testing 16 clinical samples collected from aqueous humor of patients undergoing therapeutic anterior chamber paracentesis. Comparing with gold standard colorimetric assay for AA concentration, OcuCheck showed accuracy of >80%, sensitivity of >88% and specificity of >71%. At present, there are no FDA-approved POS tests that can directly measures AA concentration levels in ocular fluid. We envisage that the device can be realized as a handheld, battery powered instrument that will have high impact on glaucoma care and point-of-care diagnostics of penetrating ocular globe injuries. PMID:26525715

Computer listing of the effects of drugs on laboratory data

PubMed Central

Young, D. S.; Thomas, D. W.; Friedman, R. B.

1972-01-01

A listing of approximately 10000 effects of drugs on tests performed in clinical laboratories has been developed in a time-shared computer. The list contains a directory for matching proprietary and generic names of drugs and an explanation for the mode of action of the drug on each test. Each entry is supported by a bibliographical reference that contains the author's names, and the title of the article and journal. It is possible to search for specific `character strings' (word or words, number, etc) to obtain all the effects of a particular drug, or all drugs that affect a particular test, or even to search for a specific explanation for an effect. The system is undergoing trial in the Department's own computer to permit of automatic correlation of the effects of drugs with laboratory data from patients in one hospital ward. PMID:4648544

You want to do what? My mother's choice to have direct-to-consumer genetic testing.

PubMed

Varga, Elizabeth A

2012-06-01

As a genetic counselor, I had mixed opinions when my mother told me of her intent to undergo genomewide, SNP-based direct-to-consumer (DTC) genetic testing. I cautioned her that results could be misleading, could increase anxiety and were often of limited clinical validity or utility. I warned of the possibility of learning unintended health information and expressed concerns about how the information might be used by a private company. I told her about the variability in results among companies. Yet, she persisted in her desire, reminding me that she was an informed consumer. After reviewing her goals and understanding of the information she might receive, she elected to proceed. Despite my insistence that I would not be her personal genetic counselor, when the results came back, I found myself immersed in her genetic data. In this manuscript, I will examine how this personal experience challenged my perceptions of DTC testing.

The impact of atosiban on pregnancy outcomes in women undergoing in vitro fertilization-embryo transfer: A meta-analysis

PubMed Central

Huang, Qian-Yi; Rong, Min-Hua; Lan, Ai-Hua; Lin, Xiao-Miao; Lin, Xing-Gu; He, Rong-Quan; Chen, Gang; Li, Mu-Jun

2017-01-01

Background Atosiban is administered to women undergoing in vitro fertilization-embryo transfer (IVF-ET) to improve pregnancy outcomes. However, the results of this treatment were controversial. We conducted this meta-analysis to investigate whether atosiban improves pregnancy outcomes in the women undergoing in vitro fertilization (IVF). Methods Databases of PubMed, EMBASE, Web of Science, China BioMedicine, and Google Scholar were systematically searched. Meta-analyses were performed to investigate whether atosiban improves pregnancy outcomes in the women undergoing IVF. Results Our results showed that atosiban was associated with higher implantation (OR = 1.63, 95% CI: 1.17–2.27; P = 0.004) and clinical pregnancy (OR = 1.84, 95% CI: 1.31–2.57; P < 0.001) rates. However, atosiban showed no significant association with the miscarriage, live birth, multiple pregnancy or ectopic pregnancy rates. When a further subgroup analysis was performed in the women undergoing repeated implantation failure (RIF), implantation (OR = 1.93, 95% CI: 1.45–2.57; P < 0.001), clinical pregnancy (OR = 2.48, 95% CI: 1.70–3.64; P <0.001) and the live birth (OR = 2.89, 95% CI: 1.78–4.67; P < 0.001) rates were significantly higher in the case group. Nevertheless, no significant difference was detected in the miscarriage and multiple pregnancy rates between the case and control groups. Conclusion Atosiban may be more appropriate for women undergoing RIF and play only a limited role in improving pregnancy outcomes in the general population of women undergoing IVF. These conclusions should be verified in large and well-designed studies. PMID:28422984

Usefulness for Predicting Cardiac Events After Orthotopic Liver Transplantation of Myocardial Perfusion Imaging and Dobutamine Stress Echocardiography Preoperatively.

PubMed

Snipelisky, David; Ray, Jordan; Vallabhajosyula, Saraschandra; Matcha, Gautam; Squier, Samuel; Lewis, Jacob; Holliday, Rex; Aggarwal, Niti; Askew, J Wells; Shapiro, Brian; Anavekar, Nandan

2017-04-01

Patients undergoing orthotopic liver transplantation have high rates of cardiac morbidity and mortality. Although guidelines recommend noninvasive stress testing as part of the preoperative evaluation, little data have evaluated clinical outcomes following orthotopic liver transplantation. A retrospective study at 2 high-volume liver transplantation centers was performed. All patients undergoing noninvasive stress testing (myocardial perfusion imaging [MPI] or dobutamine stress echocardiography [DSE]) over a 5-year period were included. Descriptive analyses, including clinical outcomes and perioperative and postoperative ischemic events, were performed. Comparisons were made between subsets of patients within each stress modality based on abnormal versus normal results. A total of 506 patients were included, of which 343 underwent DSE and 163 MPI. Few patients had abnormal results, with 19 (5.5%) in the DSE group and 13 (8%) in the MPI group. Perioperative and postoperative cardiac complications were low (n = 20, 5.8% and n = 3, 0.9% in DSE group and n = 15, 9.2% and n = 3, 1.8% in MPI group). Comparisons between abnormal versus normal findings showed a trend toward periprocedural cardiac complications in the abnormal DSE group (n = 3, 15.8% vs n = 17, 5.25%; p = 0.09) with no difference in 6-month postprocedural complications (n = 0 vs n = 3, 0.9%; p = 1.0). In the MPI group, a trend toward periprocedural ischemic complications (n = 3, 23.1% vs n = 12, 8%; p = 0.1) was noted with no difference in 6-month postprocedural complications (n = 0 vs n = 3, 2%; p = 1.0). In conclusion, our study found a significantly lower than reported cardiac event rate. In addition, it demonstrated that ischemic cardiac events are uncommon in patients with normal stress testing. Copyright © 2017 Elsevier Inc. All rights reserved.

[Anesthesia with isoflurane in air and with isoflurane and nitrous oxide].

PubMed

Girardi, G; Rossi, R; Cellai, M P; Pieraccioli, E; Novelli, G P

1994-06-01

The aim of this study is to control the depth, the quality of recovery of total inhalation isoflurane anesthesia with or without nitrous oxide. Controlled comparative study was carried out on 51 patients, aged 40-54 yr, ASA 1, undergoing saphenectomy, in an University Clinic. Induction: thiopental (3.5 mg kg), atracurium (0.6 mg kg) i.v. Patients were randomly assigned to: group 1 (26 patients), 5% isoflurane in air, by mask; group 2 (25 patients), 3% isoflurane and 60% N2O, by mask. Maintenance: group 1, 2% isoflurane in air; group 2, 1.2% isoflurane and 60% N2O. During anesthesia, consciousness and analgesia level were monitored by EEG Compressed Spectral Array, and clinical signs of pain by Evans' test; arousal time evaluation by "Time to correct response test". The subjective impressions, eventual dreams and recalls were collected using a standard set of questions one hour after the end of anesthesia and 24 hours later. One hour before anesthesia and two hours after the end of surgical procedures, a psychomotor performance recovery evaluation was performed using Zazzo's "deux barrages" test. Student's "t" test. Adequate anesthetic depth was documented in all patients. Recovery time was statistically longer in isoflurane group (group 1 16.7 sd 2.2 minutes vs 10.3 sd 1.9 minutes group 2, p < 0.01). No patient reported recalls relative to anesthetic period. Two hours after recovery no significant differences in psychomotor performance tests were recorded. Isoflurane anesthesia in air, in adequate concentrations, provides a sufficient level of analgesia, hypnosis, amnesia, without clinical side effects.

[Efficacy of lisdexamphetamine to improve the behavioural and cognitive symptoms of attention deficit hyperactivity disorder: treatment monitored by means of the AULA Nesplora virtual reality test].

PubMed

Diaz-Orueta, U; Fernandez-Fernandez, M A; Morillo-Rojas, M D; Climent, G

2016-07-01

Lisdexanfetamine (LDX) is the drug for attention deficit hyperactivity disorder (ADHD) undergoing the largest research volume in the latest years. However, no studies certify its usefulness for the improvement of cognitive functioning in ADHD. To evaluate the efficacy of LDX in the behavioral and cognitive improvement of a group of patients with ADHD. Such efficacy was measured by means of the administration of AULA Nesplora virtual reality test before the prescription of pharmacological treatment and right after the treatment with LDX. The sample comprised 85 patients between 6 and 16 years, with clinical diagnosis of ADHD, who attended treatment in a neuropediatrics consultation. All patients started pharmacological treatment with the proper dose of LDX after the clinical interview and the first administration of AULA test. After an average treatment of 7.5 months, AULA was administered again and the treatment progress based on cognitive and motor symptomatology was assessed. Results showed highly significant improvements in selective and sustained attention, quality of attention focus and hyperactivity; moderate improvements in impulsivity; and an incidence close to zero in processing speed. LDX constitutes an adequate treatment for the substantial improvement of attention and hyperactivity; such improvement can be monitored accurately by means of AULA virtual reality test.

Alcohol-containing mouthwasheses: effect on composite color.

PubMed

Settembrini, L; Penugonda, B; Scherer, W; Strassler, H; Hittelman, E

1995-01-01

This study investigated whether commercially available mouthwashes could affect or change the color of a hybrid composite resin. Twenty-four disks were fabricated and divided into eight equal groups for testing. At baseline, six colorimetric recordings and color parameters (L*, a*, b*) were recorded for each grouping of disks using a Chroma Meter CR-300 in reflectance mode. The groups of disks were immersed in their respective mouthwashes for 2 minutes a day in a vibratory fashion over a 6-month period. At the end of 6 months, color differences, delta E, were calculated between the base line and test recordings. The results indicate that rinsing with mouthwashes for 6 months can cause a hybrid resin to undergo color variations. Except for one product the color variations were not clinically significant.

Cost-effectiveness analysis of personalized antiplatelet therapy in patients with acute coronary syndrome.

PubMed

Jiang, Minghuan; You, Joyce Hs

2016-05-01

This study aimed to compare the clinical and economic outcomes of pharmacogenetic-guided (PG-guided) and platelet reactivity testing-guided antiplatelet therapy for patients with acute coronary syndrome undergoing percutaneous coronary intervention. A decision-analytic model was simulated including four antiplatelet strategies: universal clopidogrel 75 mg daily, universal alternative P2Y12 inhibitor (prasugrel or ticagrelor), PG-guided therapy, and platelet reactivity testing-guided therapy. PG-guided therapy was the preferred option with lowest cost (US$75,208) and highest quality-adjusted life years gained (7.6249 quality-adjusted life years). The base-case results were robust in sensitivity analysis. PG-guided antiplatelet therapy showed the highest probability to be preferred antiplatelet strategy for acute coronary syndrome patients with percutaneous coronary intervention.

A Mechanomodulatory Device to Minimize Incisional Scar Formation

PubMed Central

Wong, Victor W.; Beasley, Bill; Zepeda, John; Dauskardt, Reinhold H.; Yock, Paul G.; Longaker, Michael T.; Gurtner, Geoffrey C.

2013-01-01

Objective To mechanically control the wound environment and prevent cutaneous scar formation. Approach We subjected various material substrates to biomechanical testing to investigate their ability to modulate skin behavior. Combinations of elastomeric materials, adhesives, and strain applicators were evaluated to develop topical stress-shielding devices. Noninvasive imaging modalities were utilized to characterize anatomic site-specific differences in skin biomechanical properties in humans. The devices were tested in a validated large animal model of hypertrophic scarring. Phase I within-patient controlled clinical trials were conducted to confirm their safety and efficacy in scar reduction in patients undergoing abdominoplasty surgery. Results Among the tested materials and device applicators, a polymer device was developed that effectively off-loaded high tension wounds and blocked pro-fibrotic pathways and excess scar formation in red Duroc swine. In humans, different anatomic sites exhibit unique biomechanical properties that may correlate with the propensity to form scars. In the clinical trial, utilization of this device significantly reduced incisional scar formation and improved scar appearance for up to 12 months compared with control incisions that underwent routine postoperative care. Innovation This is the first device that is able to precisely control the mechanical environment of incisional wounds and has been demonstrated in multiple clinical trials to significantly reduce scar formation after surgery. Conclusion Mechanomodulatory strategies to control the incisional wound environment can significantly reduce pathologic scarring and fibrosis after surgery. PMID:24527342

Informed choice in women attending private clinics to undergo first-trimester screening for Down syndrome.

PubMed

Jaques, Alice M; Sheffield, Leslie J; Halliday, Jane L

2005-08-01

Informed choice for prenatal screening has long been considered an essential aspect of service provision, and has been researched extensively in the second trimester. This study aims at examining whether women having first-trimester screening in a private clinic had made an informed choice. A cross-sectional survey recruited women having first-trimester screening at specialist ultrasound practices. Two questionnaires containing a validated Multidimensional Measure of Informed Choice (MMIC) were self-administered pre- and post-screening. MMIC was completed by 81% (163/202) of women. Ninety-nine percent of women had a positive attitude towards screening, therefore informed choice was essentially measured on knowledge alone. Pre-screening, 68% made an informed choice, compared with 74% post-screening (chi2 = 1.6, p = 0.21 (McNemar)). Knowledge was associated with education level, information sources and perception of screening as routine or optional. The Australasian Guidelines on prenatal screening state that all women having testing should be provided with written information, and it should be ensured that they have appropriate understanding of the test(s). These guidelines are not being met, even in private clinical care. Health professionals should ensure that all women are provided with suitable information about prenatal screening that is tailored to their level of education and individual needs, and should emphasise that screening is optional. Copyright 2005 John Wiley & Sons, Ltd.

Validation study of the SCREENIVF: an instrument to screen women or men on risk for emotional maladjustment before the start of a fertility treatment.

PubMed

Ockhuijsen, Henrietta D L; van Smeden, Maarten; van den Hoogen, Agnes; Boivin, Jacky

2017-06-01

To examine construct and criterion validity of the Dutch SCREENIVF among women and men undergoing a fertility treatment. A prospective longitudinal study nested in a randomized controlled trial. University hospital. Couples, 468 women and 383 men, undergoing an IVF/intracytoplasmic sperm injection (ICSI) treatment in a fertility clinic, completed the SCREENIVF. Construct and criteria validity of the SCREENIVF. The comparative fit index and root mean square error of approximation for women and men show a good fit of the factor model. Across time, the sensitivity for Hospital Anxiety and Depression Scale subscale in women ranged from 61%-98%, specificity 53%-65%, predictive value of a positive test (PVP) 13%-56%, predictive value of a negative test (PVN) 70%-99%. The sensitivity scores for men ranged from 38%-100%, specificity 71%-75%, PVP 9%-27%, PVN 92%-100%. A prediction model revealed that for women 68.7% of the variance in the Hospital Anxiety and Depression Scale on time 1 and 42.5% at time 2 and 38.9% at time 3 was explained by the predictors, the sum score scales of the SCREENIVF. For men, 58.1% of the variance in the Hospital Anxiety and Depression Scale on time 1 and 46.5% at time 2 and 37.3% at time 3 was explained by the predictors, the sum score scales of the SCREENIVF. The SCREENIVF has good construct validity but the concurrent validity is better than the predictive validity. SCREENIVF will be most effectively used in fertility clinics at the start of treatment and should not be used as a predictive tool. Copyright © 2017 American Society for Reproductive Medicine. All rights reserved.

Interpretability of Change Scores in Measures of Balance in People With COPD.

PubMed

Beauchamp, Marla K; Harrison, Samantha L; Goldstein, Roger S; Brooks, Dina

2016-03-01

Balance deficits and an increased fall risk are well documented in individuals with COPD. Despite evidence that balance training programs can improve performance on clinical balance tests, their minimal clinically important difference (MCID) is unknown. The aim of this study was to determine the MCID of the Berg Balance Scale (BBS), Balance Evaluation Systems Test (BESTest), and Activities-Specific Balance Confidence (ABC) scale in patients with COPD undergoing pulmonary rehabilitation. We performed a secondary analysis of data from two studies of balance training in COPD (n = 55). The MCID for each balance measure was estimated using the following anchor and distribution-based approaches: (1) mean change scores on a patient-reported global change in balance scale, (2) optimal cut-point from receiver operating characteristic curves (ROCs), and (3) the minimal detectable change with 95% confidence (MDC95). Data from 55 patients with COPD (mean age, 71.2 ± 7.1 y; mean FEV1, 39.2 ± 15.8% predicted) were used in the analysis. The smallest estimate of MCID was from the ROC method. Anchor-based estimates of the MCID ranged from 3.5 to 7.1 for the BBS, 10.2 to 17.4 for the BESTest, and 14.2 to 18.5 for the ABC scale; their MDC95 values were 5.0, 13.1, and 18.9, respectively. Among patients with COPD undergoing pulmonary rehabilitation, a change of 5 to 7 points for the BBS, 13 to 17 points for the BESTest, and 19 points for the ABC scale is required to be both perceptible to patients and beyond measurement error. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Fundus findings in a series of patients with extrapulmonary tuberculosis in Thailand.

PubMed

Jirawison, Choeng; Liu, Yingna; Surasit, Karjbundid; Maningding, Ernest; Kamphaengkham, Siripim; Ausayakhun, Somsanguan; Heiden, David; Margolis, Todd P; Gonzales, John A; Acharya, Nisha R; Keenan, Jeremy David

2017-06-01

The aim of this study was to determine the frequency of fundus abnormalities among patients who are undergoing or have recently completed treatment for extrapulmonary tuberculosis (eTB). This is a prospective cross-sectional study conducted in a TB clinic of a tertiary hospital in northern Thailand. All patients who had eTB between January 2014 and August 2015 were invited by telephone to return to the clinic for fundus photography. Three uveitis specialists reviewed all photographs to identify posterior segment lesions that were consistent with ocular TB. A total of 265 patients were diagnosed with eTB during the specified period, of which 118 (44.5%) were reached by telephone and 60 (50.8%) participated in the study. A total of 7 eyes from six patients (10.0% of participants, 95% CI 2.2% to 17.8%) had lesions consistent with ocular TB. The group with possible ocular TB lesions was on average 16.8 years older than those without ocular lesions (p=0.01), but the two groups were otherwise not significantly different. Ocular lesions consistent with TB were not rare in a group of patients who were undergoing or had recently completed treatment for eTB. Fundus examination may provide diagnostic information that could influence a clinician's beliefs when diagnosing eTB. Given the low costs and immediate results of eye examination, this diagnostic test should be considered in patients suspected for eTB, especially when other tests are negative. © 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.

Cost analysis of spinal and general anesthesia for the surgical treatment of lumbar spondylosis.

PubMed

Walcott, Brian P; Khanna, Arjun; Yanamadala, Vijay; Coumans, Jean-Valery; Peterfreund, Robert A

2015-03-01

Lumbar spine surgery is typically performed under general anesthesia, although spinal anesthesia can also be used. Given the prevalence of lumbar spine surgery, small differences in cost between the two anesthetic techniques have the potential to make a large impact on overall healthcare costs. We sought to perform a cost comparison analysis of spinal versus general anesthesia for lumbar spine operations. Following Institutional Review Board approval, a retrospective cohort study was performed from 2009-2012 on consecutive patients undergoing non-instrumented, elective lumbar spine surgery for spondylosis by a single surgeon. Each patient was evaluated for both types of anesthesia, with the decision for anesthetic method being made based on a combination of physical status, anatomical considerations, and ultimately a consensus agreement between patient, surgeon, and anesthesiologist. Patient demographics and clinical characteristics were compared between the two groups. Operating room costs were calculated whilst blinded to clinical outcomes and reported in percentage difference. General anesthesia (n=319) and spinal anesthesia (n=81) patients had significantly different median operative times of 175 ± 39.08 and 158 ± 32.75 minutes, respectively (p<0.001, Mann-Whitney U test). Operating room costs were 10.33% higher for general anesthesia compared to spinal anesthesia (p=0.003, Mann-Whitney U test). Complications of spinal anesthesia included excessive movement (n=1), failed spinal attempt (n=3), intraoperative conversion to general anesthesia (n=2), and a high spinal level (n=1). In conclusion, spinal anesthesia can be performed safely in patients undergoing lumbar spine surgery. It has the potential to reduce operative times, costs, and possibly, complications. Further prospective evaluation will help to validate these findings. Copyright © 2014 Elsevier Ltd. All rights reserved.

Prevention of catheter-related bladder discomfort - pudendal nerve block with ropivacaine versus intravenous tramadol: study protocol for a randomized controlled trial.

PubMed

Li, Jing-Yi; Liao, Ren

2016-09-13

Catheter-related bladder discomfort (CRBD) is a common distressing symptom complex during the postoperative period, especially after urologic procedures with a relatively greater size urinary catheter. In this study, we will enroll male patients undergoing elective prostate surgery with urinary catheterization under general anesthesia, and we will compare the efficacy of pudendal nerve block (PNB) and intravenous tramadol in CRBD prevention. This trial is a prospective, randomized controlled trial that will test the superiority of bilateral PNB with 0.33 % ropivacaine compared with intravenous tramadol 1.5 mg/kg for CRBD prevention. A total of 94 male patients undergoing elective prostate surgery with urinary catheterization after anesthesia induction will be randomized to receive either bilateral PNB with 0.33 % ropivacaine (the PNB group) or intravenous tramadol 1.5 mg/kg (the tramadol group) after the completion of surgery. The primary outcome is the incidence of CRBD. The most important secondary outcome is the severity of postoperative CRBD, and other secondary outcomes include Numeric Rating Scale (NRS) score for postoperative pain; incidence of postoperative side effects such as postoperative nausea/vomiting, sedation, dizziness, and dry mouth; postoperative requirement for tramadol as a rescue treatment for CRBD and sufentanil as a rescue analgesic for postoperative pain; and NRS score for acceptance of an indwelling urinary catheter. This trial is planned to test the superiority of PNB with 0.33 % ropivacaine compared with intravenous tramadol 1.5 mg/kg. It may provide a basis for a new clinical practice for the prevention of CRBD. ClinicalTrials.gov identifier NCT02683070 . Registered on 11 February 2016.

Immunoconjugates in the management of hairy cell leukemia

PubMed Central

Kreitman, Robert J.; Pastan, Ira

2015-01-01

Hairy cell leukemia (HCL) is an indolent B-cell malignancy effectively treated but not often cured by purine analog therapy; after multiple courses of purine analogs, patients can become purine analog resistant and in need of alternative therapies. Complete remission to single-agent purine analog is often accompanied by minimal residual disease (MRD), residual HCL cells detectable by immunologic methods, considered a risk factor for eventual relapse. Several different non-chemotherapy approaches are being used to target relapsed and refractory HCL, including inhibitors of BRAF, but so far only monoclonal antibody (MAb)-based approaches have been reported to eliminate MRD in a high percentage of patients. One of the MAb-based options for HCL currently under clinical investigation involves recombinant immunotoxins, containing a fragment of a MAb and a bacterial toxin. The bacterial toxin, a highly potent fragment from Pseudomonas exotoxin, catalytically ADP-ribosylates elongation factor 2 (EF2), resulting in protein synthesis inhibition and apoptotic cell death. Recombinant immunotoxins tested in HCL patients include LMB-2, targeting CD25, and BL22, targeting CD22. An affinity matured version of BL22, termed moxetumomab pasudotox (formerly HA22 or CAT-8015) achieved high CR rates in phase I, and is currently undergoing multicenter Phase 3 testing. Phase I testing was without dose-limiting toxicity, although 2 patients had grade 2 hemolytic uremic syndrome (HUS) with transient grade 1 abnormalities in platelets and creatinine. Preclinical work is underway to identify residues on moxetumomab pasudotox leading to immunogenicity. Moxetumomab pasudotox is undergoing pivotal testing for relapsed and refractory HCL. PMID:26614902

Postoperative Functional Recovery After Gastrectomy in Patients Undergoing Enhanced Recovery After Surgery

PubMed Central

Jeong, Oh; Ryu, Seong Yeob; Park, Young Kyu

2016-01-01

Abstract Enhanced recovery after surgery (ERAS) is increasingly used in several abdominal surgeries to accelerate postoperative recovery and reduce the length of stay. The aim of this study was to investigate the pattern of functional recovery after gastrectomy in patients undergoing ERAS and to analyze factors that affect postoperative recovery. In all, 168 gastric cancer patients enrolled in a clinical trial evaluating ERAS compliance after gastrectomy were prospectively assessed with respect to postoperative functional recovery using discharge criteria, evaluating 4 major functional outcomes: adequate pain control, ability to mobilize and self-care, tolerance of oral intake, and no abnormal physical findings or laboratory test. The mean completion time of overall discharge criteria was 5.1 ± 3.2 days. The mean completion time for each dimension were 4.4 ± 0.9 days for adequate pain control, 4.1 ± 0.8 days for ability to mobilize and self-care, 4.3 ± 1.1 days for no abnormal physical signs or laboratory test, and 4.6 ± 1.2 days for tolerance of oral intake. The mean length of stay was 7.2 ± 3.2 days, and readmission rate was 2.4% (n = 4). There was 9.5% (n = 16) of morbidity and no hospital mortality. Female sex (P < 0.001) and age (≥65 years; P = 0.049) were significantly associated with a slower recovery in tolerance of oral intake, and total gastrectomy was significantly associated with delayed completion of adequate pain control (P = 0.003). Functional recovery after gastrectomy can be achieved after about 5 days in patients undergoing ERAS. Female sex, old age, and total gastrectomy are factors that delay normal functional recovery after gastrectomy. PMID:27057836

The effects of two methods of reflexology and stretching exercises on the severity of restless leg syndrome among hemodialysis patients.

PubMed

Shahgholian, Nahid; Jazi, Shahrzad Khojandi; Karimian, Jahangir; Valiani, Mahboubeh

2016-01-01

Restless leg syndrome prevalence is high among the patients undergoing hemodialysis. Due to several side effects of medicational treatments, the patients prefer non-medicational methods. Therefore, the present study aimed to investigate the effects of two methods of reflexology and stretching exercises on the severity of restless leg syndrome among patients undergoing hemodialysis. This study is a randomized clinical trial that was done on 90 qualified patients undergoing hemodialysis in selected hospitals of Isfahan, who were diagnosed with restless leg syndrome through standard restless leg syndrome questionnaire. They were randomly assigned by random number table to three groups: Reflexology, stretching exercises, and control groups through random allocation. Foot reflexology and stretching exercises were conducted three times a week for 30-40 min within straight 4 weeks. Data analysis was performed by SPSS version 18 using descriptive and inferential statistical analyses [one-way analysis of variance (ANOVA), paired t-test, and least significant difference (LSD) post hoc test]. There was a significant difference in the mean scores of restless leg syndrome severity between reflexology and stretching exercises groups, compared to control (P < 0.001), but there was no significant difference between the two study groups (P < 0.001). Changes in the mean score of restless leg syndrome severity were significantly higher in reflexology and stretching exercises groups compared to the control group (P < 0.001), but it showed no significant difference between reflexology massage and stretching exercises groups. Our obtained results showed that reflexology and stretching exercises can reduce the severity of restless leg syndrome. These two methods of treatment are recommended to the patients.

The effects of two methods of reflexology and stretching exercises on the severity of restless leg syndrome among hemodialysis patients

PubMed Central

Shahgholian, Nahid; Jazi, Shahrzad Khojandi; Karimian, Jahangir; Valiani, Mahboubeh

2016-01-01

Background: Restless leg syndrome prevalence is high among the patients undergoing hemodialysis. Due to several side effects of medicational treatments, the patients prefer non-medicational methods. Therefore, the present study aimed to investigate the effects of two methods of reflexology and stretching exercises on the severity of restless leg syndrome among patients undergoing hemodialysis. Materials and Methods: This study is a randomized clinical trial that was done on 90 qualified patients undergoing hemodialysis in selected hospitals of Isfahan, who were diagnosed with restless leg syndrome through standard restless leg syndrome questionnaire. They were randomly assigned by random number table to three groups: Reflexology, stretching exercises, and control groups through random allocation. Foot reflexology and stretching exercises were conducted three times a week for 30–40 min within straight 4 weeks. Data analysis was performed by SPSS version 18 using descriptive and inferential statistical analyses [one-way analysis of variance (ANOVA), paired t-test, and least significant difference (LSD) post hoc test]. Results: There was a significant difference in the mean scores of restless leg syndrome severity between reflexology and stretching exercises groups, compared to control (P < 0.001), but there was no significant difference between the two study groups (P < 0.001). Changes in the mean score of restless leg syndrome severity were significantly higher in reflexology and stretching exercises groups compared to the control group (P < 0.001), but it showed no significant difference between reflexology massage and stretching exercises groups. Conclusions: Our obtained results showed that reflexology and stretching exercises can reduce the severity of restless leg syndrome. These two methods of treatment are recommended to the patients. PMID:27186197

Use of Curcumin Mouthrinse in Radio-Chemotherapy Induced Oral Mucositis Patients: A Pilot Study.

PubMed

Patil, Karthikeya; Guledgud, Mahima V; Kulkarni, P K; Keshari, Deepika; Tayal, Srishti

2015-08-01

Oral Mucositis is a complex and distinct pathobiologic entity resulting in injuries in mucosa that is a common complication in cancer patients undergoing chemotherapy (CT) and radiation therapy (RT). Phytochemicals, such as Curcumin, turmeric extract, has attracted great attention for its therapeutic benefits in clinical oncology due to its chemopreventive, antitumoral, chemosensibilizing and radiosensibilizing activities against various types of cancers and the complications associated with their management. To evaluate the efficacy and safety of curcumin mouthwash in the management of Oral Mucositis in cancer patients undergoing radio-chemotherapy. The research group consisted of 20 adult cancer patients undergoing radio-chemotherapy at the Regional Oncology Centre, who were evaluated for signs and symptoms of oral mucositis and then randomly divided into two groups. Standard preventive oral care i.e. chlorhexidine mouthwash 0.2% was given to one group while the other group was provided with freshly prepared curcumin mouthwash; each to be used thrice daily. Oral mucositis was assessed at days 0, 10 and 20. The World Health Organization (WHO) scale, the Oral Mucositis Assessment Scale (OMAS), and a Numerical Rating Scale (NRS; patient reporting scale of 0-10) were used. Adverse events were tracked. Descriptive statistics, Independent sample t-test and repeated measure ANOVA test were performed. Statistically significant difference was found in the NRS (p=0.000), Erythema (p=0.050), ulceration (p=0.000) and WHO scores (p=0.003) between the two groups. Curcumin was found to be better than chlorhexidine mouth wash in terms of rapid wound healing and better patient compliance in management of radio-chemotherapy induced oral mucositis. No oral or systemic complications were reported.

French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3.

PubMed

Joly, F; Lange, M; Rigal, O; Correia, H; Giffard, B; Beaumont, J L; Clisant, S; Wagner, L

2012-12-01

Impairment of cognitive function, a common complaint in patients receiving chemotherapy, is usually measured through neuropsychological tests. Patient self-evaluation of cognitive difficulties is an important complement to those tests. The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) is a self-report questionnaire with potential to be used in standard clinical practice as a tool for evaluating patient's cognitive function before, during, and after chemotherapy. The purpose of our study was to conduct linguistic validation of the French version of the FACT-Cog. Both qualitative and quantitative methods were used in this study. After undergoing a rigorous translation methodology, the French FACT-Cog version was pretested in France with 35 cancer patients undergoing chemotherapy treatment. Interviews were conducted with all patients to ascertain their understanding of each item. The validation of the final version was conducted among 63 cancer patients, and sociodemographic information was collected as well as brief measure of cognitive function and depression score. Patient comments obtained through the cognitive debriefing interviews indicated that patients understand the French FACT-Cog items as they are intended and that the measure is culturally appropriate. Internal consistency reliability of the subscales, evaluated using Cronbach's coefficient alpha, was high for all four subscales: Perceived Cognitive Impairments = 0.93, Impact On QOL = 0.85, Comments From Others = 0.70, and Perceived Cognitive Abilities = 0.89. All item-total correlations for each subscale were greater than 0.20, and most were greater than 0.50. Results from this study effectively demonstrate that the French FACT-Cog is a reliable instrument for the self-reporting of cognitive abilities in patients undergoing chemotherapy.

Quality of life, symptom status and physical performance in patients with advanced non-small cell lung cancer undergoing chemotherapy: an exploratory analysis of secondary data.

PubMed

Shallwani, Shirin M; Simmonds, Maureen J; Kasymjanova, Goulnar; Spahija, Jadranka

2016-09-01

Our objectives were: (a) to identify predictors of change in health-related quality of life (HRQOL) in patients with advanced non-small cell lung cancer (NSCLC) undergoing chemotherapy; and (b) to characterize symptom status, nutritional status, physical performance and HRQOL in this population and to estimate the extent to which these variables change following two cycles of chemotherapy. A secondary analysis of a longitudinal observational study of 47 patients (24 men and 23 women) with newly diagnosed advanced NSCLC receiving two cycles of first-line chemotherapy was performed. Primary outcomes were changes in HRQOL (physical and mental component summaries (PCS and MCS) of the 36-item Short-Form Health Survey (SF-36)). Predictors in the models included pre-chemotherapy patient-reported symptoms (Schwartz Cancer Fatigue Scale (SCFS) and Lung Cancer Subscale), nutritional screening (Patient-Generated Subjective Global Assessment) and physical performance measures (6-min Walk Test (6MWT), one-minute chair rise test and grip strength). Mean SF-36 PCS score, 6MWT distance and grip strength declined following two cycles of chemotherapy (p<0.05). Multiple linear regression modelling revealed pre-chemotherapy SCFS score and 6MWT distance as the strongest predictors of change in the mental component of HRQOL accounting for 13% and 9% of the variance, respectively. No significant predictors were found for change in the physical component of HRQOL. Pre-chemotherapy 6MWT distance and fatigue severity predicted change in the mental component of HRQOL in patients with advanced NSCLC undergoing chemotherapy, while physical performance declined during treatment. Clinical management of these factors may be useful for HRQOL optimization in this population. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A multifactorial anti‐cachectic approach for cancer cachexia in a rat model undergoing chemotherapy

PubMed Central

Toledo, Míriam; Penna, Fabio; Oliva, Francesc; Luque, Melania; Betancourt, Angelica; Marmonti, Enrica; López‐Soriano, Francisco J.; Argilés, Josep M.

2015-01-01

Abstract Background The effectiveness of drugs aimed at counteracting cancer cachexia is generally tested in pre‐clinical rodent models, where only the tumour‐induced alterations are taken into account, excluding the co‐presence of anti‐tumour molecules that could worsen the scenario and/or interfere with the treatment. Methods The aim of the present investigation has been to assess the efficacy of a multifactorial treatment, including formoterol and megestrol acetate, in cachectic tumour‐bearing rats (Yoshida AH‐130, a highly cachectic tumour) undergoing chemotherapy (sorafenib). Results Treatment of cachectic tumour‐bearing rats with sorafenib (90 mg/kg) causes an important decrease in tumour cell content due to both reduced cell proliferation and increased apoptosis. As a consequence, animal survival significantly improves, while cachexia occurrence persists. Multi‐factorial treatment using both formoterol and megestrol acetate is highly effective in preventing muscle wasting and has more powerful effects than the single formoterol administration. In addition, both physical activity and grip strength are significantly improved as compared with the untreated tumour‐bearing animals. The effects of the multi‐factorial treatment include increased food intake (likely due to megestrol acetate) and decreased protein degradation, as shown by the reduced expression of genes associated with both proteasome and calpain proteolytic systems. Conclusions The combination of the two drugs proved to be a promising strategy for treating cancer cachexia in a pre‐clinical setting that better resembles the human condition, thus providing a strong rationale for the use of such combination in clinical trials involving cachectic cancer patients. PMID:27066318

Factors associated with the quality of life of adults subjected to hemodialysis in a city in northeast Brazil.

PubMed

Cavalcante, Milady Cutrim Vieira; Lamy, Zeni Carvalho; Lamy Filho, Fernando; França, Ana Karina Teixeira da Cunha; dos Santos, Alcione Miranda; Thomaz, Erika Bárbara Abreu Fonseca; da Silva, Antonio Augusto Moura; Salgado Filho, Natalino

2013-01-01

There is a known association between low scores for quality of life (QOL) and higher rates of hospitalization, mortality in hemodialysis vascular access catheter, older age, lack of regular occupation, presence of comorbidities and hypoalbuminemia. There is still no agreement about the influence of sex, educational level, socioeconomic status and treatment time on the worst levels of QOL. Identify socioeconomic, demographic, clinical, nutritional and laboratory factors associated with worse QOL in adults undergoing hemodialysis in Sao Luís, Maranhão, Brazil. A cross-sectional study which evaluated the QOL of patients with chronic renal disease, aged 20-59 years, undergoing hemodialysis. Two instruments were used: the Kidney Disease Quality of Life -Short Form 1.3 (KDQOL-SF™ 1.3) and a questionnaire on socioeconomic, demographic, clinical, nutritional and laboratory data. The reliability of KDQOL-SF™ 1.3 was assessed by Cronbach's alpha. For the multivariable analysis a Poisson regression model with robust adjustment of the standard error was used. The reliability assessment of KDQOL-SF™ 1.3 showed a Cronbach's alpha test greater than 0.8 in all areas. The areas with the worst levels of QOL were "work situation", "burden of kidney disease", "patient satisfaction", "physical function" and "general health". Having less than 8 years of schooling, coming from the countryside and having cardiovascular disease were associated to the areas with the worst levels of QOL. KDQOL-SF™ 1.3 is a reliable instrument to measure quality of life of hemodialysis patients. Demographic and clinical conditions can negatively influence QOL in chronic renal failure patients.

Effects of multiple inherited and acquired thrombophilia on outcomes of in-vitro fertilization.

PubMed

Di Nisio, Marcello; Ponzano, Adalisa; Tiboni, Gianmario; Guglielmi, Maria Domenica; Rutjes, Anne Wilhelmina Saskia; Porreca, Ettore

2018-05-09

The effects of multiple inherited and acquired thrombophilic defects on the outcome of in-vitro fertilization (IVF) remain unexplored. The aim of this study was to evaluate the association between multiple thrombophilia and clinical outcomes in a large prospective cohort of women undergoing IVF. Consecutive women scheduled for IVF were eligible. The primary study outcome was live birth. Secondary outcomes included spontaneous abortion, clinical pregnancy, and symptomatic venous thromboembolism. 687 women with a mean age of 34.6 (±3.2) years were included. Overall, 22 women (3.2%) had two or more thrombophilic defects. The probability of live birth was not statistically significantly different between women with ≥2 thrombophilia (odds ratio [OR] 0.62; 95% confidence interval [CI], 0.18 to 2.11) or ≥1 thrombophilia (OR 0.67;95% CI, 0.41 to 1.09) and women without any thrombophilia. None of the individual inherited thrombophilia nor positivity to antiphospholipid antibodies or lupus anticoagulant were associated with live birth. Single positivity for lupus anticoagulant carried a more than threefold higher risk of abortion (OR 3.74; 95% CI, 1.30 to 10.75). There were no statistically significant associations between individual or multiple thrombophilic defects and clinical pregnancy or pregnancy test results. No woman had a history of venous thromboembolism and none developed a thrombotic event during the study. In women undergoing IVF, the presence of two or more thrombophilic defects was rare and showed no statistically significant associations with IVF outcomes. Copyright © 2018 Elsevier Ltd. All rights reserved.

[Management of Patients on Antithrombotic Agents Undergoing Endoscopy].

PubMed

Kim, Joon Sung; Kim, Byung Wook

2018-05-25

Antithrombotic agents are used increasingly in Asia. The management of patients on antithrombotics undergoing elective or emergency endoscopy has become an increasing clinical challenge for gastroenterologists. Current practice guidelines have been developed by societies from western countries. On the other hand, these guidelines cannot meet the specific needs of the Asian Pacific region, raising the need for separate guidelines in Asia. This review compares the recommendations of previous guidelines with the most recently published Asian guidelines regarding the management of patients on antithrombotic agents undergoing elective and emergency endoscopy.

Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol.

PubMed

Moller, David R; Koth, Laura L; Maier, Lisa A; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K; Collman, Ronald G; Hamzeh, Nabeel; Sweiss, Nadera J; Zhang, Yingze; O'Neal, Scott; Senior, Robert M; Becich, Michael; Hochheiser, Harry S; Kaminski, Naftali; Wisniewski, Stephen R; Gibson, Kevin F

2015-10-01

Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant's clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis.

Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol

PubMed Central

Koth, Laura L.; Maier, Lisa A.; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K.; Collman, Ronald G.; Hamzeh, Nabeel; Sweiss, Nadera J.; Zhang, Yingze; O’Neal, Scott; Senior, Robert M.; Becich, Michael; Hochheiser, Harry S.; Kaminski, Naftali; Wisniewski, Stephen R.; Gibson, Kevin F.

2015-01-01

Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant’s clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis. PMID:26193069

New diagnostic pathways urgently needed. Protocol of PET Guidance I pilot study: positron emission tomography in suspected cardiac implantable electronic device-related infection.

PubMed

Marciniak-Emmons, Marta Barbara; Sterliński, Maciej; Syska, Paweł; Maciąg, Aleksander; Farkowski, Michał Mirosław; Firek, Bohdan; Dziuk, Mirosław; Zając, Dariusz; Pytkowski, Mariusz; Szwed, Hanna

2016-01-01

Cardiovascular implantable electronic device (CIED) infection is a complication of increasing incidence. We present a protocol of an observational case control clinical trial "Positron Emission Tomography Combined With Computed Tomography (PET CT) in Suspected Cardiac Implantable Electronic Device Infection, a Pilot Study - PET Guidance I" (NCT02196753). The aim of this observational clinical trial is to assess and standardise diagnostic algorithms for CIED infections (lead-dependent infective endocarditis, generator pocket infection, fever of unknown origin) with PET CT in Poland. Study group will consist of 20 patients with initial diagnosis of CIED-related infection paired with a control group of 20 patients with implanted CIEDs, who underwent PET CT due to other non-infectious indications and have no data for infectious process in follow-up. All patients included in the study will undergo standard diagnostic pro-cess. Conventional/standard diagnostic and therapeutic process will consist of: medical interview, physical examination, laboratory tests, blood cultures; imaging studies: echocardiography: transthoracic (TTE), and, if there are no contraindications transoesophageal, computed tomography scan for pulmonary embolism if indicated; if there are abnormalities in other systems, decisions concerning further diagnostics will be made at the physician's discretion. As well as standard diagnostic procedures, patients will undergo whole body PET CT scan to localise infection or inflammation. Diagnosis and therapeutic decision will be obtained from the Study Committee. Follow-up will be held within six months with control visits at three and six months. During each follow-up visit, all patients will undergo laboratory tests, two blood cultures collected 1 h apart, and TTE. In case of actual clinical suspicion of infective endocarditis or local generator pocket infection, patients will be referred for further diagnostics. Endpoints for the results assessment - primary endpoints are to standardise PET CT in the diagnostic process: sensitivity, specificity, positive predictive value, and negative predictive value of the diagnosis made by PET CT; secondary endpoints are: assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, infected pulmonary emboli), incidence of particular localisations of infection, influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT, safety and complications of diagnostic process of CIED-related infections with PET CT. Evaluation of PET CT use for device-related infections in a case control study may be conclusive and improve diagnostic pathway.

Initial Results of Multigene Panel Testing for Hereditary Breast and Ovarian Cancer and Lynch Syndrome.

PubMed

Howarth, Dt R; Lum, Sharon S; Esquivel, Pamela; Garberoglio, Carlos A; Senthil, Maheswari; Solomon, Naveenraj L

2015-10-01

Multigene panel testing for hereditary cancer risk has recently become commercially available; however, the impact of its use on patient care is undefined. We sought to evaluate results from implementation of panel testing in a multidisciplinary cancer center. We performed a retrospective review of consecutive patients undergoing genetic testing after initiating use of multigene panel testing at Loma Linda University Medical Center. From February 13 to August 25, 2014, 92 patients were referred for genetic testing based on National Comprehensive Cancer Network guidelines. Testing was completed in 90 patients. Overall, nine (10%) pathogenic mutations were identified: five BRCA1/2, and four in non-BRCA loci. Single-site testing identified one BRCA1 and one BRCA2 mutation. The remaining mutations were identified by use of panel testing for hereditary breast and ovarian cancer. There were 40 variants of uncertain significance identified in 34 patients. The use of panel testing more than doubled the identification rate of clinically significant pathogenic mutations that would have been missed with BRCA testing alone. The large number of variants of uncertain significance identified will require long-term follow-up for potential reclassification. Multigene panel testing provides additional information that may improve patient outcomes.

Comparison of neurocognitive results after coronary artery bypass grafting and thoracic aortic surgery using retrograde cerebral perfusion.

PubMed

Miyairi, Takeshi; Takamoto, Shinichi; Kotsuka, Yutaka; Takeuchi, Atsuko; Yamanaka, Katsuo; Sato, Hajime

2005-07-01

Retrograde cerebral perfusion (RCP) is used as an adjunctive method to hypothermic circulatory arrest to enhance cerebral protection in patients undergoing thoracic aortic surgery. It remains unclear whether RCP provides improved neurological and neuropsychological outcome. Forty-six patients undergoing thoracic aortic surgery using RCP, and 28 undergoing coronary artery bypass grafting (CABG; n = 28) with CPB, were enrolled in the study. Patients receiving RCP were subdivided into two groups, those with less than 60 min of RCP (S-RCP; n = 27) and with 60 min or more (L-RCP; n = 19). The patients' neurocognitive state was assessed by the revised Wechsler Adult Intelligence Scale a few days before operation, at 2-3 weeks and 4-6 months after operation. There were no stroke, seizure, and hospital mortality in either group. Significant decline between baseline and early scores were seen in three subtests (digit span, arithmetic, and picture completion) for S-RCP and four (digit span, arithmetic, picture completion, and picture arrangement) for L-RCP. Significant decline between baseline and late scores were seen in one subtest (arithmetic) for S-RCP, four (digit span, arithmetic, picture completion, and picture arrangement) for L-RCP, and one (object assembly) for CABG. The mean change of scores for one late test (digit symbol) was significantly lower in S-RCP than in CABG. The mean change of scores for three early tests (digit span, vocabulary, and picture arrangement) and four late tests (information, digit span, picture completion, and picture arrangement) were significantly lower in L-RCP than in CABG. Stepwise logistic regression analysis disclosed that, after considering the other variables, significant difference in test score changes were observed between CABG and L-RCP for two early tests (picture completion and digit symbol) as well as for three late tests (digit span, similarities, and picture completion). None of test score changes showed significant difference between CABG and S-RCP. The neurocognitive outcome in patients undergoing RCP less than 60 min were comparable with patients undergoing CABG without circulatory arrest. Prolonged RCP of 60 min or more in patients undergoing surgery of the thoracic aorta was associated with postoperative neurocognitive impairment.

Effects of Nutritional Prehabilitation, With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: a Systematic Review and Meta-analysis.

PubMed

Gillis, Chelsia; Buhler, Katherine; Bresee, Lauren; Carli, Francesco; Gramlich, Leah; Culos-Reed, Nicole; Sajobi, Tolulope T; Fenton, Tanis R

2018-05-08

Although there have been meta-analyses of the effects of exercise prehabilitation on patients undergoing colorectal surgery, little is known about the effects of nutrition-only (oral nutritional supplements and/or counseling) and multi-modal (oral nutritional supplements and/or counseling with exercise) prehabilitation on clinical outcomes and patient function after surgery. We performed a systemic review and meta-analysis to determine the individual and combined effects of nutrition-only and multi-modal prehabilitation, compared with no prehabilitation (control), on outcomes of patients undergoing colorectal resection. We searched MEDLINE, EMBASE, CINAHL, CENTRAL, and ProQuest for cohort and randomized controlled studies of adults awaiting colorectal surgery who received at least 7 days of oral nutrition supplements and/or nutrition counselling with or without exercise. We performed a random effects meta-analysis to estimate the pooled risk ratio for categorical data and the weighted mean difference for continuous variables. The primary outcome was length of hospital stay; the secondary outcome was recovery of functional capacity, based on results of a 6-minute walk test. We identified 9 studies (5 randomized controlled studies and 4 cohort studies) comprising 914 patients undergoing colorectal surgery (438 received prehabilitation and 476 served as controls). Receipt of any prehabilitation significantly reduced days spent in hospital compared with controls (weighted mean difference of length of hospital stay, -2.2 days; 95% CI, -3.5 days to -0.9 days). Only 3 studies reported functional outcomes but could not be pooled due to methodological heterogeneity. In the individual studies, multimodal prehabilitation significantly improved results of the 6-minute walk test at 4 and 8 weeks after surgery compared with standard enhanced recovery pathway care, and at 8 weeks compared with standard enhanced recovery pathway care with added rehabilitation. The 4 observational studies had a high risk of bias. In a systematic review and meta-analysis, we found that nutritional prehabilitation alone, or when combined with an exercise program, significantly reduced length of hospital stay by 2 days in patients undergoing colorectal surgery. There is some evidence that multimodal prehabilitation accelerated the return to pre-surgery functional capacity. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

Intrathecal hypobaric versus hyperbaric bupivacaine with morphine for cesarean section.

PubMed

Richardson, M G; Collins, H V; Wissler, R N

1998-08-01

Both hyper- and hypobaric solutions of bupivacaine are often combined with morphine to provide subarachnoid anesthesia for cesarean section. Differences in the baricity of subarachnoid solutions influence the intrathecal distribution of anesthetic drugs and would be expected to influence measurable clinical variables. We compared the effects of hyper- and hypobaric subarachnoid bupivacaine with morphine to determine whether one has significant advantages with regard to intraoperative anesthesia and postoperative analgesia in term parturients undergoing elective cesarean section. Thirty parturients were randomized to receive either hyper- or hypobaric bupivacaine (15 mg) with morphine sulfate (0.2 mg). Intraoperative outcomes compared included extent of sensory block, quality of anesthesia, and side effects. Postoperative outcomes, including pain visual analog scale scores, systemic analgesic requirements, and side effects, were monitored for 48 h. Sedation effects were quantified and compared using Trieger and digit-symbol substitution tests. We detected no differences in sensory or motor block, quality of anesthesia, quality of postoperative analgesia, incidence of side effects, or psychometric scores. Both preparations provide highly satisfactory anesthesia for cesarean section and effective postoperative analgesia. Dextrose alters the density of intrathecal bupivacaine solutions and is thought to influence subarachnoid distribution of the drug. We randomized parturients undergoing cesarean section to one of two often used spinal bupivacaine preparations, hypobaric and hyperbaric. We detected no differences in clinical outcomes between groups.

Study design and rationale for Optimal aNtiplatelet pharmacotherapy guided by bedSIDE genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST): a prospective, open-label, randomised parallel-group multicentre trial (NCT01930773).

PubMed

Kołtowski, Łukasz; Aradi, Daniel; Huczek, Zenon; Tomaniak, Mariusz; Sibbing, Dirk; Filipiak, Krzysztof J; Kochman, Janusz; Balsam, Paweł; Opolski, Grzegorz

2016-01-01

High platelet reactivity (HPR) and presence of CYP2C19 loss-of-function alleles are associated with higher risk for periprocedural myocardial infarction in clopidogrel-treated patients undergoing percutaneous coronary intervention (PCI). It is unknown whether personalised treatment based on platelet function testing or genotyping can prevent such complications. The ONSIDE-TEST is a multicentre, prospective, open-label, randomised controlled clinical trial aiming to assess if optimisation of antiplatelet therapy based on either phenotyping or genotyping is superior to conventional care. Patients will be randomised into phenotyping, genotyping, or control arms. In the phenotyping group, patients will be tested with the VerifyNow P2Y12 assay before PCI, and patients with a platelet reactivity unit greater than 208 will be switched over to prasugrel, while others will continue on clopidogrel therapy. In the genotyping group, carriers of the *2 loss-of-function allele will receive prasugrel for PCI, while wild-type subjects will be treated with clopidogrel. Patients in the control arm will be treated with standard-dose clopidogrel. The primary endpoint of the study is the prevalence of periprocedural myocardial injury within 24 h after PCI in the controls as compared to the phenotyping and genotyping group. Secondary endpoints include cardiac death, myocardial infarction, definite or probable stent thrombosis, or urgent repeat revascularisation within 30 days of PCI. Primary safety outcome is Bleeding Academic Research Consortium (BARC) type 3 and 5 bleeding during 30 days of PCI. The ONSIDE TEST trial is expected to verify the clinical utility of an individualised antiplatelet strategy in preventing periprocedural myocardial injury by either phenotyping or genotyping. ClinicalTrials.gov: NCT01930773.

Utility of antenatal clinical factors for prediction of postpartum outcomes in women with gestational diabetes mellitus (GDM).

PubMed

Ingram, Emily R; Robertson, Iain K; Ogden, Kathryn J; Dennis, Amanda E; Campbell, Joanne E; Corbould, Anne M

2017-06-01

Gestational diabetes mellitus (GDM) is associated with life-long increased risk of type 2 diabetes: affected women are advised to undergo oral glucose tolerance testing (OGTT) at 6-12 weeks postpartum, then glucose screening every 1-3 years. We investigated whether in women with GDM, antenatal clinical factors predicted postpartum abnormal glucose tolerance and compliance with screening. In women with GDM delivering 2007 to mid-2009 in a single hospital, antenatal/obstetric data and glucose tests at 6-12 weeks postpartum and during 5.5 years post-pregnancy were retrospectively collected. Predictors of return for testing and abnormal glucose tolerance were identified using multivariate analysis. Of 165 women, 117 (70.9%) returned for 6-12 week postpartum OGTT: 23 (19.6%) were abnormal. Smoking and parity, independent of socioeconomic status, were associated with non-return for testing. Fasting glucose ≥5.4 mmol/L on pregnancy OGTT predicted both non-return for testing and abnormal OGTT. During 5.5 years post-pregnancy, 148 (89.7%) women accessed glucose screening: nine (6.1%) developed diabetes, 33 (22.3%) had impaired fasting glucose / impaired glucose tolerance. Predictors of abnormal glucose tolerance were fasting glucose ≥5.4 mmol/L and 2-h glucose ≥9.3 mmol/L on pregnancy OGTT (~2.5-fold increased risk), and polycystic ovary syndrome (~3.4 fold increased risk). Risk score calculation, based on combined antenatal factors, did not improve predictions. Antenatal clinical factors were modestly predictive of return for testing and abnormal glucose tolerance post-pregnancy in women with GDM. Risk score calculations were ineffective in predicting outcomes: risk scores developed in other populations require validation. Ongoing glucose screening is indicated for all women with GDM. © 2016 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Recipient screening in IVF: first data from women undergoing anonymous oocyte donation in Dublin.

PubMed

Walsh, Anthony P H; Omar, Ahmed B; Marron, Kevin D; Walsh, David J; Salma, Umme; Sills, E Scott

2011-04-20

Guidelines for safe gamete donation have emphasised donor screening, although none exist specifically for testing oocyte recipients. Pre-treatment assessment of anonymous donor oocyte IVF treatment in Ireland must comply with the European Union Tissues and Cells Directive (Directive 2004/23/EC). To determine the effectiveness of this Directive when applied to anonymous oocyte recipients in IVF, we reviewed data derived from selected screening tests performed in this clinical setting. Data from tests conducted at baseline for all women enrolling as recipients (n = 225) in the anonymous oocyte donor IVF programme at an urban IVF referral centre during a 24-month period were analysed. Patient age at programme entry and clinical pregnancy rate were also tabulated. All recipients had at least one prior negative test for HIV, Hepatitis B/C, chlamydia, gonorrhoea and syphilis performed by her GP or other primary care provider before reproductive endocrinology consultation. Mean (±SD) age for donor egg IVF recipients was 40.7 ± 4.2 yrs. No baseline positive chlamydia, gonorrhoea or syphilis screening results were identified among recipients for anonymous oocyte donation IVF during the assessment interval. Mean pregnancy rate (per embryo transfer) in this group was 50.5%. When tests for HIV, Hepatitis B/C, chlamydia, gonorrhoea and syphilis already have been confirmed to be negative before starting the anonymous donor oocyte IVF sequence, additional (repeat) testing on the recipient contributes no new clinical information that would influence treatment in this setting. Patient safety does not appear to be enhanced by application of Directive 2004/23/EC to recipients of anonymous donor oocyte IVF treatment. Given the absence of evidence to quantify risk, this practice is difficult to justify when applied to this low-risk population.

Yamamoto New Scalp Acupuncture for postoperative pain management in cats undergoing ovariohysterectomy.

PubMed

Ribeiro, Matheus R; de Carvalho, Carolina B; Pereira, Ricardo H Z; Nicácio, Gabriel M; Brinholi, Rejane B; Cassu, Renata N

2017-09-01

To evaluate the analgesic efficacy of Yamamoto New Scalp Acupuncture (YNSA) as an adjuvant for postoperative pain management in cats. Prospective, randomized, blinded, clinical study. Twenty cats aged (mean ± standard deviation) 25 ± 9 months and weighing 2.7 ± 0.6 kg undergoing ovariohysterectomy. The cats were sedated with intramuscular (IM) ketamine (5 mg kg -1 ), midazolam (0.5 mg kg -1 ) and tramadol (2 mg kg -1 ). The cats were randomly distributed before induction of anesthesia into two groups of 10 cats each: group YNSA, in which bilateral basic D points were stimulated with a dry needle from 20 minutes prior to anesthetic induction to the end of the surgery; group Control, in which no acupuncture was applied. Postoperative analgesia was assessed at 1, 2, 4, 8, 12, 18 and 24 hours postextubation using an Interactive Visual Analog Scale and Universidade Estadual Paulista-Botucatu Multidimensional Composite Pain Scale (UNESP-Botucatu MCPS). Rescue analgesia was provided with IM tramadol (2 mg kg -1 ), and the pain scores were reassessed 30 minutes after rescue intervention. If the analgesia remained insufficient, meloxicam (0.2 mg kg -1 as a single dose) was administered IM. Data were analyzed using Student t-test, Fisher exact test, Mann-Whitney U test and Friedman test (p < 0.05). Significantly lower pain scores were observed in YNSA when compared with Control at 1-4 hours based on the UNESP-Botucatu MCPS scores. Although significant differences were not identified between groups requiring rescue analgesia, additional postoperative analgesia was administered to four of 10 cats in Control and no cats in YNSA. Perioperative YNSA resulted in decreased pain scores and a reduction in postoperative requirement for rescue analgesia in cats. This method should be considered a viable option as an adjuvant analgesic therapy for cats undergoing ovariohysterectomy. Copyright © 2017 Association of Veterinary Anaesthetists and American College of Veterinary Anesthesia and Analgesia. Published by Elsevier Ltd. All rights reserved.

Controlling Motion Sickness and Spatial Disorientation and Enhancing Vestibular Rehabilitation with a User-Worn See-Through Display

PubMed Central

Krueger, Wesley W.O.

2010-01-01

Objectives/Hypotheses An eyewear mounted visual display (“User-worn see-through display”) projecting an artificial horizon aligned with the user's head and body position in space can prevent or lessen motion sickness in susceptible individuals when in a motion provocative environment as well as aid patients undergoing vestibular rehabilitation. In this project, a wearable display device, including software technology and hardware, was developed and a phase I feasibility study and phase II clinical trial for safety and efficacy were performed. Study Design Both phase I and phase II were prospective studies funded by the NIH. The phase II study used repeated measures for motion intolerant subjects and a randomized control group (display device/no display device) pre-post test design for patients in vestibular rehabilitation. Methods Following technology and display device development, 75 patients were evaluated by test and rating scales in the phase II study; 25 subjects with motion intolerance used the technology in the display device in provocative environments and completed subjective rating scales while 50 patients were evaluated before and after vestibular rehabilitation (25 using the display device and 25 in a control group) using established test measures. Results All patients with motion intolerance rated the technology as helpful for nine symptoms assessed, and 96% rated the display device as simple and easy to use. Duration of symptoms significantly decreased with use of the technology displayed. In patients undergoing vestibular rehabilitation, there were no significant differences in amount of change from pre- to post-therapy on objective balance tests between display device users and controls. However, those using the technology required significantly fewer rehabilitation sessions to achieve those outcomes than the control group. Conclusions A user-worn see-through display, utilizing a visual fixation target coupled with a stable artificial horizon and aligned with user movement, has demonstrated substantial benefit for individuals susceptible to motion intolerance and spatial disorientation and those undergoing vestibular rehabilitation. The technology developed has applications in any environment where motion sensitivity affects human performance. PMID:21181963

Herpes simplex encephalitis as a complication of neurosurgical procedures: report of 3 cases and review of the literature.

PubMed

Jaques, David A; Bagetakou, Spyridoula; L'Huillier, Arnaud G; Bartoli, Andrea; Vargas, Maria-Isabel; Fluss, Joel; Kaiser, Laurent

2016-05-23

Herpes simplex virus (HSV) is the most common identified cause of focal encephalitis worldwide. However, postoperative HSV encephalitis (HSVE) is a rare complication of neurosurgical procedures and a significant clinical challenge We describe 3 cases of postoperative HSVE and review all published reports. A total of 23 cases were identified. Clinical heterogeneity represents a diagnostic challenge in the postoperative setting. Cerebral magnetic resonance imaging showed typical findings in a minority of patients only, whereas HSV-specific polymerase chain reaction on the cerebrospinal fluid proved to be a valuable test. The postoperative viral pathophysiology remains a subject of debate. The rate of adverse outcome is high and early antiviral treatment seems to be a strong predictor of clinical outcome. We recommend early empirical treatment for any patient presenting with post-neurosurgical lymphocytic meningo-encephalitis, and prophylactic antiviral treatment for patients with a history of previous HSVE who will undergo a neurosurgical procedure.

A feasibility study for a clinical decision support system prompting HIV testing.

PubMed

Chadwick, D R; Hall, C; Rae, C; Rayment, Ml; Branch, M; Littlewood, J; Sullivan, A

2017-07-01

Levels of undiagnosed HIV infection and late presentation remain high globally despite attempts to increase testing. The objective of this study was to evaluate a risk-based prototype application to prompt HIV testing when patients undergo routine blood tests. Two computer physician order entry (CPOE) systems were modified using the application to prompt health care workers (HCWs) to add an HIV test when other tests selected suggested that the patient was at higher risk of HIV infection. The application was applied for a 3-month period in two areas, in a large London hospital and in general practices in Teesside/North Yorkshire. At the end of the evaluation period, HCWs were interviewed to assess the usability and acceptability of the prompt. Numbers of HIV tests ordered in the general practice areas were also compared before and after the prompt's introduction. The system was found to be both useable and generally acceptable to hospital doctors, general practitioners and nurse practitioners, with little evidence of prompt/alert fatigue. The issue of the prompt appearing late in the patient consultation did lead to some difficulties, particularly around discussion of the test and consent. In the general practices, around 1 in 10 prompts were accepted and there was a 6% increase in testing rates over the 3-month study period (P = 0.169). Using a CPOE-based clinical decision support application to prompt HIV testing appears both feasible and acceptable to HCWs. Refining the application to provide more accurate risk stratification is likely to make it more effective. © 2016 British HIV Association.

Establishing an Australian nurse practitioner-led colorectal cancer screening clinic.

PubMed

Morcom, Joylene; Dunn, Sandra V; Luxford, Yoni

2005-01-01

In Australia, colorectal cancer is the most commonly occurring internal cancer affecting both men and women, and the second most common cause of cancer-related death. Flexible sigmoidoscopy has not been commonly used as a screening tool in Australia due primarily to lack of resources. Until now, people at average risk of developing bowel cancer frequently undergo colonoscopy after referral to a specialist. To fill an identified need, a nurse practitioner-led colorectal screening service providing fecal occult blood testing and flexible sigmoidoscopy, health education and promotion, patient counseling, information and a referral point for general practitioners, and a referral service for above average-risk patients was established in a South Australian metropolitan teaching hospital. Establishment of this clinic required advanced and extended theoretical and clinical preparation for the nurse practitioner, as well as development of interdisciplinary relationships, referral processes, clinical infrastructure, and a marketing strategy. An audit of the first 100 flexible sigmoidoscopy patients revealed service and procedural outcomes that compared favorably with other colorectal screening services as well as a high level of patient satisfaction.

Brain natriuretic peptide levels predict perioperative events in cardiac patients undergoing noncardiac surgery: a prospective study.

PubMed

Leibowitz, David; Planer, David; Rott, David; Elitzur, Yair; Chajek-Shaul, Tova; Weiss, A Teddy

2008-01-01

Brain natriuretic peptide (BNP) levels correlate with prognosis in patients with cardiac disease and may be useful in the risk stratification of cardiac patients undergoing noncardiac surgery (NCS). The objective of this study was to examine whether BNP levels predict perioperative events in cardiac patients undergoing NCS. Patients undergoing NCS with at least 1 of the following criteria were included: a clinical history of congestive heart failure (CHF), ejection fraction <40%, or severe aortic stenosis. All patients underwent echocardiography and measurement of BNP performed using the ADVIA-Centaur BNP assay (Bayer HealthCare). Clinical endpoints were death, myocardial infarction or pulmonary congestion requiring intravenous diuretics at 30 days of follow-up. Forty-four patients were entered into the study; 15 patients (34%) developed cardiac postoperative complications. The mean BNP level was 1,366 +/- 1,420 pg/ml in patients with events and 167 +/- 194 pg/ml in patients without events, indicating a highly significant difference (p < 0.001). The ROC area under the curve was 0.91 (95% CI 0.83-0.99) with an optimal cutoff of >165 pg/ml (100% sensitivity, 70% specificity). BNP levels may predict perioperative complications in cardiac patients undergoing NCS, and the measurement of BNP should be considered to assess the preoperative cardiac risk. (c) 2007 S. Karger AG, Basel

Outcome of breath tests in adult patients with suspected small intestinal bacterial overgrowth

PubMed Central

Mattsson, Johanna; Minaya, Maria Teresa; Monegro, Milka; Lebwohl, Benjamin; Lewis, Suzanne K.; Green, Peter HR; Stenberg, Reidun

2017-01-01

Aim: The aim was to investigate breath test outcomes in patients with suspected SIBO and indicative symptoms of SIBO, diagnosed by breath testing. Background: Breath testing is used to detect small intestinal bacterial overgrowth (SIBO) by measuring hydrogen and methane produced by intestinal bacteria. Methods: This retrospective cross sectional study included 311 patients with gastrointestinal symptoms who underwent the breath test for evaluation of SIBO at Celiac Disease Center at Columbia University, New York, in 2014-2015. The patients were divided into two groups based on the physician’s choice: lactulose breath test group (72%) and glucose breath test group (28%). Among them, 38% had a history of celiac disease or non-celiac gluten sensitivity. Results: In total, 46% had a positive breath test: 18% were positive for methane, 24 % positive for hydrogen and 4% positive for both gases (p=0.014). Also, 50% had a positive lactulose breath result and 37% had a positive glucose breath result (p=0.036). The most common symptom for performing the breath test was bloating and the only clinical symptom that significantly showed a positive glucose breath test was increased gas (p=0.028). Conclusion: Lactulose breath test was more often positive than glucose breath test. Positivity for hydrogen was more common than methane. Bloating was the most frequently perceived symptom of the patients undergoing the breath test but the only statistically significant clinical symptom for a positive glucose breath test was increased gas. Furthermore, the results showed that there was no significant association between positive breath test result and gender, age, non-celiac gluten sensitivity or celiac disease. PMID:29118931

The Use of Mystery Shopping for Quality Assurance Evaluations of HIV/STI Testing Sites Offering Services to Young Gay and Bisexual Men

PubMed Central

Bauermeister, José A.; Pingel, Emily S.; Jadwin-Cakmak, Laura; Meanley, Steven; Alapati, Deepak; Moore, Michael; Lowther, Matthew; Wade, Ryan; Harper, Gary W.

2015-01-01

Young men who have sex with men (YMSM) are at increased risk for HIV and STI infection. While encouraging HIV and STI testing among YMSM remains a public health priority, we know little about the cultural competency of providers offering HIV/STI tests to YMSM in public clinics. As part of a larger intervention study, we employed a mystery shopper methodology to evaluate the LGBT cultural competency and quality of services offered in HIV and STI testing sites in Southeast Michigan (n = 43).We trained and deployed mystery shoppers (n = 5) to evaluate the HIV and STI testing sites by undergoing routine HIV/STI testing. Two shoppers visited each site, recording their experiences using a checklist that assessed 13 domains, including the clinic’s structural characteristics and interactions with testing providers. We used the site scores to examine the checklist’s psychometric properties and tested whether site evaluations differed between sites only offering HIV testing (n = 14) versus those offering comprehensive HIV/STI testing (n = 29). On average, site scores were positive across domains. In bivariate comparisons by type of testing site, HIV testing sites were more likely than comprehensive HIV/STI testing clinics to ascertain experiences of intimate partner violence, offer action steps to achieve safer sex goals, and provide safer sex education. The developed checklist may be used as a quality assurance indicator to measure HIV/STI testing sites’ performance when working with YMSM. Our findings also underscore the need to bolster providers’ provision of safer sex education and behavioral counseling within comprehensive HIV/STI testing sites. PMID:26303197

Preimplantation genetic screening for all 24 chromosomes by microarray comparative genomic hybridization significantly increases implantation rates and clinical pregnancy rates in patients undergoing in vitro fertilization with poor prognosis

PubMed Central

Majumdar, Gaurav; Majumdar, Abha; Lall, Meena; Verma, Ishwar C.; Upadhyaya, Kailash C.

2016-01-01

CONTEXT: A majority of human embryos produced in vitro are aneuploid, especially in couples undergoing in vitro fertilization (IVF) with poor prognosis. Preimplantation genetic screening (PGS) for all 24 chromosomes has the potential to select the most euploid embryos for transfer in such cases. AIM: To study the efficacy of PGS for all 24 chromosomes by microarray comparative genomic hybridization (array CGH) in Indian couples undergoing IVF cycles with poor prognosis. SETTINGS AND DESIGN: A retrospective, case–control study was undertaken in an institution-based tertiary care IVF center to compare the clinical outcomes of twenty patients, who underwent 21 PGS cycles with poor prognosis, with 128 non-PGS patients in the control group, with the same inclusion criterion as for the PGS group. MATERIALS AND METHODS: Single cells were obtained by laser-assisted embryo biopsy from day 3 embryos and subsequently analyzed by array CGH for all 24 chromosomes. Once the array CGH results were available on the morning of day 5, only chromosomally normal embryos that had progressed to blastocyst stage were transferred. RESULTS: The implantation rate and clinical pregnancy rate (PR) per transfer were found to be significantly higher in the PGS group than in the control group (63.2% vs. 26.2%, P = 0.001 and 73.3% vs. 36.7%, P = 0.006, respectively), while the multiple PRs sharply declined from 31.9% to 9.1% in the PGS group. CONCLUSIONS: In this pilot study, we have shown that PGS by array CGH can improve the clinical outcome in patients undergoing IVF with poor prognosis. PMID:27382234

The incidence of spontaneous movements (myoclonus) in dogs undergoing total intravenous anaesthesia with propofol.

PubMed

Cattai, Andrea; Rabozzi, Roberto; Natale, Valentina; Franci, Paolo

2015-01-01

To evaluate the incidence of myoclonus (involuntary movements during anaesthesia, unrelated to inadequate hypnosis or analgesia, and of sufficient severity to require treatment) in dogs anaesthetized with a TIVA of propofol with or without the use of fentanyl. Retrospective clinical study. Dogs, undergoing general anaesthesia for clinical procedures between January 2012 and January 2013 and subject to TIVA with propofol. A retrospective analysis reviewed the medical and anaesthetic records. Animals with existing or potential neurological or neuromuscular pathology in the anamnesis or upon clinical examination and cases with incomplete clinical records were excluded. Myoclonus was considered as involuntary muscle contractions which did not cease following a bolus administration of propofol or fentanyl and, due to their intensity and duration, made continuation of the procedure impracticable without other drug administration. Tremors, paddling or muscle spasms, explicable as insufficient hypnosis or analgesia, and transient excitatory phenomena only present during the awakening phase, were not considered as myoclonus. Out of a total of 492 dogs undergoing anaesthesia, six mixed breed dogs (1.2%), one male and five females, American Society of Anaesthesiologists (ASA) physical status I, median (range) weight 20.5 (7-37) kg and age 1.5 (1-5) years had myoclonus according to the aforementioned definition. In all subjects, myoclonus appeared within 20 minutes after induction of anaesthesia, and mainly involved the limb muscles. All subjects appeared to be in an adequate plane of anaesthesia before and during myoclonus. This study shows that 1.2% of dogs, undergoing TIVA with propofol with or without fentanyl administration, developed myoclonus, which required to be, and were treated successfully pharmacologically. The cause of this phenomenon is yet to be determined. © 2014 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia.

Clinical outcome in children with chronic granulomatous disease managed conservatively or with hematopoietic stem cell transplantation.

PubMed

Cole, Theresa; Pearce, Mark S; Cant, Andrew J; Cale, Catherine M; Goldblatt, David; Gennery, Andrew R

2013-11-01

Chronic granulomatous disease (CGD) is a primary immunodeficiency characterized by serious infections and inflammation. It can be managed conservatively with prophylactic antimicrobial agents or curatively with hematopoietic stem cell transplantation (HSCT). In the United Kingdom and Ireland there are cohorts of children managed both conservatively and curatively. This study aimed to compare clinical outcomes (mortality and morbidity) in children managed conservatively and curatively. Children were identified from specialist centers and advertising through special interest groups. Clinical data were collected from medical records regarding infections, inflammatory complications and growth, other admissions, and curative treatment. Comparisons were made for patients not undergoing HSCT and patients after HSCT. Seventy-three living children were identified, 59 (80%) of whom were recruited. Five deceased children were also identified. Clinical information was available for 62 children (4 deceased). Thirty (48%) children had undergone HSCT. Children who did not undergo transplantation had 0.71 episodes of infection/admission/surgery per CGD life year (95% CI, 0.69-0.75 events per year). Post-HSCT children had 0.15 episodes of infection/admission/surgery per transplant year (95% CI, 0.09-0.21 events per year). The mean z score for height and body mass index (BMI) for age was significantly better in post-HSCT children. Survival in the non-HSCT group was 90% at age 15 years. Survival in the post-HSCT group was 90%. Children with CGD not undergoing transplantation have more serious infections, episodes of surgery, and admissions compared with post-HSCT children. Children undergoing transplantation have better height for age. Survival is good at the end of the pediatric age range and also after HSCT. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Method for detecting pollutants. [through chemical reactions and heat treatment

NASA Technical Reports Server (NTRS)

Rogowski, R. S.; Richards, R. R.; Conway, E. J. (Inventor)

1976-01-01

A method is described for detecting and measuring trace amounts of pollutants of the group consisting of ozone, nitrogen dioxide, and carbon monoxide in a gaseous environment. A sample organic solid material that will undergo a chemical reaction with the test pollutant is exposed to the test environment and thereafter, when heated in the temperature range of 100-200 C., undergoes chemiluminescence that is measured and recorded as a function of concentration of the test pollutant. The chemiluminescence of the solid organic material is specific to the pollutant being tested.

Remote Ischemic Preconditioning and Outcomes of Cardiac Surgery.

PubMed

Hausenloy, Derek J; Candilio, Luciano; Evans, Richard; Ariti, Cono; Jenkins, David P; Kolvekar, Shyam; Knight, Rosemary; Kunst, Gudrun; Laing, Christopher; Nicholas, Jennifer; Pepper, John; Robertson, Steven; Xenou, Maria; Clayton, Tim; Yellon, Derek M

2015-10-08

Whether remote ischemic preconditioning (transient ischemia and reperfusion of the arm) can improve clinical outcomes in patients undergoing coronary-artery bypass graft (CABG) surgery is not known. We investigated this question in a randomized trial. We conducted a multicenter, sham-controlled trial involving adults at increased surgical risk who were undergoing on-pump CABG (with or without valve surgery) with blood cardioplegia. After anesthesia induction and before surgical incision, patients were randomly assigned to remote ischemic preconditioning (four 5-minute inflations and deflations of a standard blood-pressure cuff on the upper arm) or sham conditioning (control group). Anesthetic management and perioperative care were not standardized. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, coronary revascularization, or stroke, assessed 12 months after randomization. We enrolled a total of 1612 patients (811 in the control group and 801 in the ischemic-preconditioning group) at 30 cardiac surgery centers in the United Kingdom. There was no significant difference in the cumulative incidence of the primary end point at 12 months between the patients in the remote ischemic preconditioning group and those in the control group (212 patients [26.5%] and 225 patients [27.7%], respectively; hazard ratio with ischemic preconditioning, 0.95; 95% confidence interval, 0.79 to 1.15; P=0.58). Furthermore, there were no significant between-group differences in either adverse events or the secondary end points of perioperative myocardial injury (assessed on the basis of the area under the curve for the high-sensitivity assay of serum troponin T at 72 hours), inotrope score (calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery), acute kidney injury, duration of stay in the intensive care unit and hospital, distance on the 6-minute walk test, and quality of life. Remote ischemic preconditioning did not improve clinical outcomes in patients undergoing elective on-pump CABG with or without valve surgery. (Funded by the Efficacy and Mechanism Evaluation Program [a Medical Research Council and National Institute of Health Research partnership] and the British Heart Foundation; ERICCA ClinicalTrials.gov number, NCT01247545.).

Validation of the breast evaluation questionnaire for breast hypertrophy and breast reduction.

PubMed

Lewin, Richard; Elander, Anna; Lundberg, Jonas; Hansson, Emma; Thorarinsson, Andri; Claudelin, Malin; Bladh, Helena; Lidén, Mattias

2018-06-13

There is a lack of published, validated questionnaires for evaluating psychosocial morbidity in patients with breast hypertrophy undergoing breast reduction surgery. To validate the breast evaluation questionnaire (BEQ), originally developed for the assessment of breast augmentation patients, for the assessment of psychosocial morbidity in patients with breast hypertrophy undergoing breast reduction surgery. Validation study Subjects: Women with macromastia Methods: The validation of the BEQ, adapted to breast reduction, was performed in several steps. Content validity, reliability, construct validity and responsiveness were assessed. The original version was adjusted according to the results for content validity and resulted in item reduction and a modified BEQ (mBEQ) that was then assessed for reliability, construct validity and responsiveness. Internal and external validation was performed for the modified BEQ. Convergent validity was tested against Breast-Q (reduction) and discriminate validity was tested against the SF-36. Known-groups validation revealed significant differences between the normal population and patients undergoing breast reduction surgery. The BEQ showed good reliability by test-re-test analysis and high responsiveness. The modified BEQ may be reliable, valid and responsive instrument for assessing women who undergo breast reduction.

Women's experiences receiving abnormal prenatal chromosomal microarray testing results.

PubMed

Bernhardt, Barbara A; Soucier, Danielle; Hanson, Karen; Savage, Melissa S; Jackson, Laird; Wapner, Ronald J

2013-02-01

Genomic microarrays can detect copy-number variants not detectable by conventional cytogenetics. This technology is diffusing rapidly into prenatal settings even though the clinical implications of many copy-number variants are currently unknown. We conducted a qualitative pilot study to explore the experiences of women receiving abnormal results from prenatal microarray testing performed in a research setting. Participants were a subset of women participating in a multicenter prospective study "Prenatal Cytogenetic Diagnosis by Array-based Copy Number Analysis." Telephone interviews were conducted with 23 women receiving abnormal prenatal microarray results. We found that five key elements dominated the experiences of women who had received abnormal prenatal microarray results: an offer too good to pass up, blindsided by the results, uncertainty and unquantifiable risks, need for support, and toxic knowledge. As prenatal microarray testing is increasingly used, uncertain findings will be common, resulting in greater need for careful pre- and posttest counseling, and more education of and resources for providers so they can adequately support the women who are undergoing testing.

The immediate effects of therapeutic keyboard music playing for finger training in adults undergoing hand rehabilitation.

PubMed

Zhang, Xiaoying; Liu, Songhuai; Yang, Degang; Du, Liangjie; Wang, Ziyuan

2016-08-01

[Purpose] The purpose of this study was to examine the immediate effects of therapeutic keyboard music playing on the finger function of subjects' hands through measurements of the joint position error test, surface electromyography, probe reaction time, and writing time. [Subjects and Methods] Ten subjects were divided randomly into experimental and control groups. The experimental group used therapeutic keyboard music playing and the control group used grip training. All subjects were assessed and evaluated by the joint position error test, surface electromyography, probe reaction time, and writing time. [Results] After accomplishing therapeutic keyboard music playing and grip training, surface electromyography of the two groups showed no significant change, but joint position error test, probe reaction time, and writing time obviously improved. [Conclusion] These results suggest that therapeutic keyboard music playing is an effective and novel treatment for improving joint position error test scores, probe reaction time, and writing time, and it should be promoted widely in clinics.

Turnaround Time for Early Infant HIV Diagnosis in Rural Zambia: A Chart Review

PubMed Central

Sutcliffe, Catherine G.; van Dijk, Janneke H.; Hamangaba, Francis; Mayani, Felix; Moss, William J.

2014-01-01

Background Early infant HIV diagnosis is challenging in sub-Saharan Africa, particularly in rural areas where laboratory capacity is limited. Specimens must be transported to central laboratories for testing, leading to delays in diagnosis and initiation of antiretroviral therapy. This study was undertaken in rural Zambia to measure the turnaround time for confirmation of HIV infection and identify delays in diagnosis. Methods Chart reviews were conducted from 2010–2012 for children undergoing early infant HIV diagnosis at Macha Hospital in Zambia. Relevant dates, receipt of drugs by mother and child for the prevention of mother-to-child transmission (PMTCT), and test results were abstracted. Results 403 infants provided 476 samples for early infant diagnosis. The median age at the “6-week” and “6-month” assessments was 8.1 weeks and 7.0 months, respectively. The majority of mothers (80%) and infants (67%) received PMTCT. The median time between sample collection and arrival at the central laboratory in Lusaka was 17 days (IQR: 10, 28); arrival at the central laboratory to testing was 6 days (IQR: 5, 11); testing to return of results to the clinic was 29 days (IQR: 17, 36); arrival of results at the clinic to return of results to the caregiver was 45 days (IQR: 24, 79). The total median time from sample collection to return of results to the caregiver was 92 days (IQR: 84, 145). The proportion of HIV PCR positive samples was 12%. The total median turnaround time was shorter for HIV PCR positive as compared to negative or invalid samples (85 vs. 92 days; p = 0.08). Conclusions Delays in processing and communicating test results were identified, particularly in returning results from the central laboratory to the clinic and from the clinic to the caregiver. A more efficient process is needed so that caregivers can be provided test results more rapidly, potentially resulting in earlier treatment initiation and better outcomes for HIV-infected infants. PMID:24475214

Racing performance of Standardbred trotting horses undergoing surgery of the carpal flexor sheath and age- and sex-matched control horses.

PubMed

Carmalt, James L; Johansson, Bengt C; Zetterström, Sandra M; McOnie, Rebecca C

2017-07-01

OBJECTIVE To determine factors affecting race speed in Swedish Standardbred horses undergoing surgery of the carpal flexor sheath (CFS), to investigate whether preoperative racing speed was associated with specific intraoperative findings and whether horses returned to racing, and to compare the performance of horses undergoing surgery of the CFS with that of age- and sex-matched control horses. ANIMALS 149 Swedish Standardbred trotters undergoing surgery of the CFS and 274 age- and sex-matched control horses. PROCEDURES Medical records of CFS horses were examined. Racing data for CFS and control horses were retrieved from official online records. Generalizing estimating equations were used to examine overall and presurgery racing speeds and the association of preoperative clinical and intraoperative findings with preoperative and postoperative speeds. Multivariable regression analysis was used to examine career earnings and number of career races. Kaplan-Meier survival analysis was used to compare career longevity between CFS and control horses. RESULTS CFS horses were significantly faster than control horses. The CFS horses that raced before surgery were slower as they approached the surgery date, but race speed increased after surgery. There were 124 of 137 (90.5%) CFS horses that raced after surgery. No intrathecal pathological findings were significantly associated with preoperative racing speed. Career longevity did not differ between CFS and control horses. CONCLUSIONS AND CLINICAL RELEVANCE Horses undergoing surgery of the CFS had a good prognosis to return to racing after surgery. Racing careers of horses undergoing surgery of the CFS were not significantly different from racing careers of control horses.

Next-Generation of Allergen-Specific Immunotherapies: Molecular Approaches.

PubMed

Curin, Mirela; Khaitov, Musa; Karaulov, Alexander; Namazova-Baranova, Leyla; Campana, Raffaela; Garib, Victoria; Valenta, Rudolf

2018-06-09

The aim of this article is to discuss how allergen-specific immunotherapy (AIT) can be improved through molecular approaches. We provide a summary of next-generation molecular AIT approaches and of their clinical evaluation. Furthermore, we discuss the potential of next generation molecular AIT forms for the treatment of severe manifestations of allergy and mention possible future molecular strategies for the secondary and primary prevention of allergy. AIT has important advantages over symptomatic forms of allergy treatment but its further development is limited by the quality of the therapeutic antigen preparations which are derived from natural allergen sources. The field of allergy diagnosis is currently undergoing a dramatic improvement through the use of molecular testing with defined, mainly recombinant allergens which allows high-resolution diagnosis. Several studies demonstrate that molecular testing in early childhood can predict the development of symptomatic allergy later on in life. Clinical studies indicate that molecular AIT approaches have the potential to improve therapy of allergic diseases and may be used as allergen-specific forms of secondary and eventually primary prevention for allergy.

Effect of cryopreservation on sperm DNA integrity in patients with teratospermia.

PubMed

Kalthur, Guruprasad; Adiga, Satish Kumar; Upadhya, Dinesh; Rao, Satish; Kumar, Pratap

2008-06-01

To test whether sperm with abnormal head morphology are more likely to undergo DNA damage and/or chromatin modification during the process of freeze-thawing. In this prospective study, the semen samples from forty-four men attending the infertility clinic were included. Samples were divided into aliquots to allow direct comparison of fresh and frozen spermatozoa from the same ejaculate. The sperm morphology and the sperm DNA damage were evaluated before and after cryopreservation. The relationship between sperm head abnormalities and freeze-thaw-induced DNA modification was assessed. University hospital fertility center. Men attending infertility clinic for semen analysis. The normospermic and teratospermic semen samples were evaluated for DNA damage before and after cryopreservation by comet assay and acridine orange bindability test. Elucidation of association between sperm morphologic defect and cryodamage. A threefold increase in the amount of DNA damage was observed in teratospermic samples compared with their normospermic counterparts, indicating a higher susceptibility of morphologically abnormal sperm to cryodamage. The susceptibility of morphologically abnormal sperm to DNA damage/chromatin modification during the freeze-thaw process is significantly higher than that of sperm with normal morphology.

Clinical and Cost Implications of Universal Versus Locally Advanced-Stage and Advanced-Stage-Only Molecular Testing for Epidermal Growth Factor Receptor Mutations and Anaplastic Lymphoma Kinase Rearrangements in Non-Small Cell Lung Carcinoma: A Tertiary Academic Institution Experience.

PubMed

Sauter, Jennifer L; Butnor, Kelly J

2016-04-01

Although epidermal growth factor receptor (EGFR)- and anaplastic lymphoma kinase (ALK)-directed therapies are not approved for patients with early-stage non-small cell lung carcinoma (NSCLC), many institutions perform EGFR and ALK testing for all patients with NSCLC at the time of initial diagnosis. Current consensus guidelines recommend EGFR testing and suggest ALK testing at the time of initial diagnosis for patients with advanced disease. To examine the cost and clinical impact of EGFR and ALK testing of patients with early-stage NSCLC. Records from all patients with a diagnosis of NSCLC made on a nonresection specimen at our institution during a single calendar year (2012) were reviewed, and a cost analysis was performed. Of 133 total patients, 47 (35%) had early-stage (stage I or II) disease and 86 (65%) had locally advanced (stage III) or advanced (stage IV) disease at presentation. Eight of 47 patients with early-stage disease (17%) had progression/recurrence during 18 to 30 months of follow-up, 6 of 8 (75%) of whom had pathologic confirmation of progression/recurrence. The estimated additional cost of EGFR and ALK testing for all newly diagnosed patients with NSCLC at our institution is $75,200 per year, compared to testing only patients with locally advanced and advanced-stage disease. The cost of universal molecular testing of NSCLC is substantial. EGFR and ALK testing of patients with early-stage disease appears to have negligible clinical impact, as most patients do not have disease recurrence/progression. Those whose disease recurs/progresses typically undergo rebiopsy. Our findings do not support the practice of universal EGFR and ALK testing in NSCLC at the time of initial diagnosis.

Cyclooxygenase-2 expression after preoperative chemoradiotherapy correlates with more frequent esophageal cancer recurrence

PubMed Central

Yoshikawa, Reigetsu; Fujiwara, Yoshinori; Koishi, Kenji; Kojima, Syoudou; Matsumoto, Tomohiro; Yanagi, Hidenori; Yamamura, Takehira; Hashimoto-Tamaoki, Tomoko; Nishigami, Takashi; Tsujimura, Tohru

2007-01-01

AIM: To investigate the relationship between cycloo-xygenase-2 (COX-2), and vascular endothelial growth factor (VEGF), and to determine the clinical significance of this relationship in esophageal cancer patients undergoing chemoradiotherapy (CRT). METHODS: Immunohistochemical staining was used to evaluate COX-2 and VEGF expression in 40 patients with histologically-confirmed esophageal squamous carcinoma (ESCC) who were undergoing preoperative CRT. RESULTS: Fourteen out of 40 ESCC patients showed a pathological complete response (CR) after CRT. COX-2 and VEGF protein expressions were observed in the cytoplasm of 17 and 13 tumors, respectively, with null expression in 9 and 13 tumors, respectively. COX-2 expression was strongly correlated with VEGF expression (P < 0.05). There were also significant associations between COX-2 expression, tumor recurrence, and lymph-node involvement (P = 0.0277 and P = 0.0095, respectively). COX-2 expression and VEGF expression had significant prognostic value for disease-free survival (log-rank test; P = 0.0073 and P = 0.0341, respectively), but not for overall survival, as assessed by univariate analysis. CONCLUSION: Our results suggest that COX-2 expression correlates with VEGF expression and might be a useful prognostic factor for more frequent tumor recurrence in ESCC patients undergoing neoadjuvant CRT. These findings support the use of anti-angiogenic COX-2 inhibitors in the treatment of ESCC. PMID:17511025

Evaluation of the Swedish version of the Child Drawing: Hospital Manual.

PubMed

Wennström, Berith; Nasic, Salmir; Hedelin, Hans; Bergh, Ingrid

2011-05-01

This paper is a report of psychometric testing of the Swedish version of the Child Drawing: Hospital Manual. Drawings have shown to be useful in assessing emotional status and anxiety in children because they generally speak to us more clearly and openly through their drawings than they are willing or able to verbally. The Child Drawing: Hospital Manual was translated into Swedish according to World Health Organization guidelines (a routine procedure for translation of English instruments) in order to assess anxiety by analysing the drawings of 59 children (5-11 years), of whom nine were girls and 50 boys undergoing day surgery during 2007-2009. Inter-rater reliability (five independent scorers) was high and internal consistency reliability was good (coefficient alpha =0·77). Parts A and C, as well as the total scale score of the Child Drawing: Hospital Manual, discriminated anxiety significantly between the group of children undergoing day surgery and a comparison group of school children, indicating adequate construct validity. For the Swedish version of the Child Drawing: Hospital Manual, our study demonstrates evidence for adequate construct validity in Parts A and C (and total scale score), high inter-rater reliability and acceptable internal consistency reliability. However, some improvements are needed before the instrument will be a clinically useful assessment of anxiety in children undergoing day surgery. © 2011 Blackwell Publishing Ltd.

The effect of perioperative beta-blockade on the pulmonary function of patients undergoing major arterial surgery.

PubMed

Kieran, S M; Cahill, R A; Browne, I; Sheehan, S J; Mehigan, D; Barry, M C

2006-09-01

Concern about the potential detrimental side-effects of beta-blockade on pulmonary function often dissuades against their perioperative use in patients undergoing major arterial surgery (especially in those with chronic obstructive pulmonary disease (COPD)). In this study we aimed to establish prospectively the clinical relevance of these concerns. After ethics committee approval and individual informed consent, the pulmonary function of twenty patients (mean age 68.7 years (range 43-82), 11 males) scheduled to undergo non-emergency major vascular surgery was studied by recording symptoms and spirometry before and after institution of effective beta-blockade. Fifteen patients (75%) had significant smoking histories (mean pack years/patient=50), while 12 (60%) had COPD. All patients tolerated effective beta-blockade satisfactorily without developing either subjective deterioration in symptoms or significant change on spirometry. The mean change in FEV1 following adequate beta-blockade was 0.05+/-0.24 liters (95% CI -0.06 to +1.61), p=0.35, giving a mean percentage change of 3.18%+/-11.66 (95% CI -2.26 to 8.62). Previously held concerns about worsening pulmonary function through the short-term use of beta-blockers should not dissuade their perioperative usage in patients with peripheral vascular disease. Furthermore, the accuracy of pulmonary function tests in preoperative assessment and risk stratification also appears unaffected by this therapy.

[Professional or household performance of patients with breast cancer undergoing chemotherapy].

PubMed

Martins, Lourdes Conceição; Ferreira Filho, Celso; Del Giglio, Auro; Munhoes, Daniela Armonia; Trevizan, Lígia Lopes Balsalobre; Herbst, Lívia Grigoriitchuk; Viera, Mariana da Cunha; Taranto, Patrícia; Pachon, Susy Cunha

2009-01-01

Evaluate patients with breast cancer undergoing chemotherapy with respect to their epidemiologic and clinical variables as well as performance at work or at home. this was a cross-sectional study including 52 women interviewed during breast cancer chemotherapy, stratified in two groups: those who continued to work and do household tasks, and did not continue to work or do household tasks. Patients were from two public hospitals in the State of São Paulo, one in Santo Andre and the other in São Bernardo do Campo. The WPAI - GH (Work Productivity and Activity Impairment) questionnaire was used to evaluate work and household performance of professionals or housewives, respectively. Mean age of the patients was 55.7 (SD=13.8), most were Caucasian (88.5%), married (55.8%), employed (65.3%) and the majority had to stop working because of treatment (51.0%), at more advanced stage (p<0.05), fatigue and nausea (p<0.05). Mean WPAI - GH was 67.04 (|SD = 5.62) for patients who stopped working and 49.17 (SD = 6.89) for those who continued to work (Mann-Whitney U test: p = 0.04). Chemotherapy leads to a decrease in performance of a sizable fraction of women with breast cancer undergoing chemotherapy. A more advanced stage of neoplasia was positively associated with withdrawal from these activities probably due to side effects such as fatigue and nausea.

Fat and neurosurgery: does obesity affect outcome after intracranial surgery?

PubMed

Schultheiss, Kim E; Jang, Yeon Gyoe; Yanowitch, Rachel N; Tolentino, Jocelyn; Curry, Daniel J; Lüders, Jürgen; Asgarzadie-Gadim, Farbod; Macdonald, R Loch

2009-02-01

Obesity has been linked to increased morbidity and mortality after some surgical procedures. The purpose of this study was to determine whether obesity affects outcome after general neurosurgery and subarachnoid hemorrhage (SAH). Three data sets were analyzed, including a retrospective review of 404 patients undergoing cranial and spinal neurosurgical procedures, a prospective collection of 100 patients with aneurysmal SAH, and data from 3567 patients with aneurysmal SAH who were entered into randomized clinical trials of tirilazad. For each data set, outcome was assessed by mortality, postoperative morbidity, and Glasgow Outcome Scale score. Prognostic factors, including body weight and body mass index, were tested for their effect on these outcomes using multivariable logistic regression. For patients undergoing general cranial and spinal neurosurgery, independent predictors of morbidity and mortality were age, American Society of Anesthesia class, disseminated malignancy, emergency surgery, and increased duration of surgery. For patients with SAH, score on the Glasgow Outcome Scale was associated with age and admission Glasgow Coma Scale score. In the tirilazad data set, multiple factors were associated with score on the Glasgow Outcome Scale, but, as with the other 2 data sets, body weight had no relationship to outcome. Obesity may have less effect on the outcome of patients with mainly cranial neurosurgical disease and aneurysmal SAH than it does on patients undergoing other types of surgery.

Environmental Test Screening Procedure

NASA Technical Reports Server (NTRS)

Zeidler, Janet

2000-01-01

This procedure describes the methods to be used for environmental stress screening (ESS) of the Lightning Mapper Sensor (LMS) lens assembly. Unless otherwise specified, the procedures shall be completed in the order listed, prior to performance of the Acceptance Test Procedure (ATP). The first unit, S/N 001, will be subjected to the Qualification Vibration Levels, while the remainder will be tested at the Operational Level. Prior to ESS, all units will undergo Pre-ESS Functional Testing that includes measuring the on-axis and plus or minus 0.95 full field Modulation Transfer Function and Back Focal Length. Next, all units will undergo ESS testing, and then Acceptance testing per PR 460.

Nanoparticle-Delivered Chemotherapy: Old Drugs in New Packages.

PubMed

Lee, Michael S; Dees, E Claire; Wang, Andrew Z

2017-03-15

Cytotoxic chemotherapies have a narrow therapeutic window, with high peaks and troughs of plasma concentration. Novel nanoparticle formulations of cytotoxic chemotherapy drugs can enhance pharmacokinetic characteristics and facilitate passive targeting of drugs to tumors via the enhanced permeability and retention effect, thus mitigating toxicity. Nanoparticle vehicles currently in clinical use or undergoing clinical investigation for anticancer therapies include liposomes, polymeric micelles, protein-drug nanoparticles, and dendrimers. Multiple nanoparticle formulations of existing cytotoxic chemotherapies are approved for use in several indications, with clinical data indeed showing optimization of pharmacokinetics and different toxicity profiles compared with their parent drugs. There are also many new nanoparticle drug formulations in development and undergoing early- and late-phase clinical trials, including several that utilize active targeting or triggered release based on environmental stimuli. Here, we review the rationale for nanoparticle formulations of existing or previously investigated cytotoxic drugs, describe currently approved nanoparticle formulations of drugs, and discuss some of the most promising clinical trials currently underway.

Prostate-specific antigen (PSA) testing of men in UK general practice: a 10-year longitudinal cohort study.

PubMed

Young, Grace J; Harrison, Sean; Turner, Emma L; Walsh, Eleanor I; Oliver, Steven E; Ben-Shlomo, Yoav; Evans, Simon; Lane, J Athene; Neal, David E; Hamdy, Freddie C; Donovan, Jenny L; Martin, Richard M; Metcalfe, Chris

2017-10-30

Cross-sectional studies suggest that around 6% of men undergo prostate-specific antigen (PSA) testing each year in UK general practice (GP). This longitudinal study aims to determine the cumulative testing pattern of men over a 10-year period and whether this testing can be considered equivalent to screening for prostate cancer (PCa). Patient-level data on PSA tests, biopsies and PCa diagnoses were obtained from the UK Clinical Practice Research Datalink (CPRD) for the years 2002 to 2011. The cumulative risks of PSA testing and of being diagnosed with PCa were estimated for the 10-year study period. Associations of a man's age, region and index of multiple deprivation with the cumulative risk of PSA testing and PCa diagnosis were investigated. Rates of biopsy and diagnosis, following a high test result, were compared with those from the programme of PSA testing in the Prostate Testing for Cancer and Treatment (ProtecT) study. The 10-year risk of exposure to at least one PSA test in men aged 45 to 69 years in UK GP was 39.2% (95% CI 39.0 to 39.4%). The age-specific risks ranged from 25.2% for men aged 45-49 years to 53.0% for men aged 65-69 years (p for trend <0.001). For those with a PSA level ≥3, a test in UK GP was less likely to result in a biopsy (6%) and/or diagnosis of PCa (15%) compared with ProtecT study participants (85% and 34%, respectively). A high proportion of men aged 45-69 years undergo PSA tests in UK GP: 39% over a 10-year period. A high proportion of these tests appear to be for the investigation of lower urinary tract symptoms and not screening for PCa. ISRCTN20141297,NCT02044172. © 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.

Technique-associated outcomes in horses following large colon resection.

PubMed

Pezzanite, Lynn M; Hackett, Eileen S

2017-11-01

To compare survival and complications in horses undergoing large colon resection with either sutured end-to-end or stapled functional end-to-end anastomoses. Retrospective cohort study. Twenty-six client-owned horses with gastrointestinal disease. Retrospective data were retrieved from the medical records of 26 horses undergoing colectomy, including 14 horses with sutured end-to-end and 12 horses with stapled functional end-to-end anastomoses, between 2003 and 2016. Records were evaluated for signalment, medical and surgical treatments, and survival to hospital discharge. Long-term follow-up was obtained through owner contact. Continuous variables were compared with Mann-Whitney tests. Fisher's exact testing was used to compare survival to hospital discharge. Survival time was compared by constructing Kaplan-Meier survival curves and performing log-rank curve comparison testing. Mean age of horses undergoing colectomy was 13 years. Reason for colectomy was prophylaxis (12) or salvage (14). Mean surgical time was 169 minutes. Mean hospitalization time was 9 days, which did not differ with anastomosis type (P = .62). Nine of 12 horses undergoing stapled functional end-to-end anastomosis and 12 of 14 horses undergoing sutured end-to-end anastomosis survived to hospital discharge (P = .63). Survival time did not differ with anastomosis technique (P = .35). Short- and long-term survival outcomes are not different between sutured end-to-end or stapled functional end-to-end anastomoses in horses undergoing colectomy. © 2017 The American College of Veterinary Surgeons.

Effects of Reiki on Pain, Anxiety, and Blood Pressure in Patients Undergoing Knee Replacement: A Pilot Study.

PubMed

Baldwin, Ann Linda; Vitale, Anne; Brownell, Elise; Kryak, Elizabeth; Rand, William

This blinded, controlled pilot study investigated the effects of Reiki on 46 patients undergoing knee replacement surgery. Of the 3 groups, Reiki, Sham Reiki, and Standard of Care, only the Reiki group showed significant reductions in pain, blood pressure, respiration rate, and state anxiety, which provides evidence for a full-scale clinical study.

Great prospects for fiber optics sensors

NASA Technical Reports Server (NTRS)

Hansen, T. E.

1983-01-01

Fiber optic sensors provide noise immunity and galvanic insulation at the measurement point. Interest in such sensors is increasing for these reasons. In the United States sales are expected to increase from 12 million dollars in 1981 to 180 million in 1991. Interferometric sensors based on single modus fibers deliver extremely high sensitivity, while sensors based on multi-modus fibers are more easily manufactured. The fiber optic sensors which are available today are based on point measurements. Development of fiber optic sensors in Norway is being carried out at the Central institute and has resulted in the development of medical manometers which are now undergoing clinical testing.

The use of a non-benzodiazepine hypnotic sleep-aid (Zolpidem) in patients undergoing ACL reconstruction: a randomized controlled clinical trial.

PubMed

Tompkins, Marc; Plante, Matthew; Monchik, Keith; Fleming, Braden; Fadale, Paul

2011-05-01

Previous studies have addressed post-operative pain management after ACL reconstruction by examining the use of intra-articular analgesia and/or modification of anesthesia techniques. To our knowledge, however, no previous studies have evaluated the effect of zolpidem on post-operative narcotic requirements, pain, and fatigue in patients undergoing outpatient arthroscopic ACL reconstruction. The purpose of this prospective, blinded, randomized, controlled clinical study was to evaluate the effect of zolpidem on post-operative narcotic requirements, pain, and fatigue in patients undergoing outpatient arthroscopic ACL reconstruction. Twenty-nine patients undergoing arthroscopic ACL reconstruction were randomized to a treatment group or placebo group. Both groups received post-operative hydrocodone/acetaminophen bitartrate (Vicodin ES). Patients in the treatment group received a single dose of zolpidem for the first seven post-operative nights. Patients in the placebo group received a gelatin capsule similar in appearance to zolpidem. The amount of Vicodin used in each group, the amount of post-operative pain, and the amount of post-operative fatigue were analyzed. Following ACL reconstruction, a 28% reduction was seen in the total amount of narcotic consumed with zolpidem (P = 0.047) when compared to placebo. There were no significant differences in post-operative pain or fatigue levels between zolpidem and placebo. Adding zolpidem to the post-operative medication regimen after arthroscopic ACL reconstruction helps to lower the amount of narcotic pain medication required for adequate analgesia. Randomized controlled clinical trial, Level I.

Using micropower impulse radar technology to screen for pneumothorax: an international bi-institutional study.

PubMed

van der Wilden, Gwendolyn M; Van der Wilden, Gwen; Albers, Christoph E; Albers, Christof; Haefeli, Pascal C; Haefeli, Peter; Zimmermann, Heinz; Zimmerman, Heinz; Exadaktylos, Aristomenis; Exadaktylos, Aris; Levy, Phillip; Birkhan, Oscar; Birkham, Oscar; Michaildou, Maria; Michailidou, Maria; Sideris, Antonios; Velmahos, George C; Velmahos, George; Alam, Hasan B; Alam, Hasan; King, David R; King, David; Fagenholz, Peter J; Fagenholz, Peter; Yeh, D Dante; Yeh, Dante; de Moya, Marc A

2012-12-01

Pneumothoraces (PTXs) are a common entity in thoracic trauma. Micropower impulse radar (MIR) has been able to detect PTXs in surgical patients. However, this technology has not been tested previously on trauma patients. The purpose of this study was to determine the sensitivity and specificity of MIR to detect clinically significant PTXs. We hypothesized that MIR technology can effectively screen trauma patients for clinically significant PTXs. This was a prospective observational study in Level I trauma centers in Boston, Massachusetts, and Bern, Switzerland. All trauma patients undergoing a chest computed tomographic (CT) scan were eligible for the study. Consent was obtained, and readings were performed within 30 minutes before or after the CT scan. The patients had eight lung fields tested (four on each side). The qualitative and quantitative MIR results were blinded and stored on the device. We then compared the results of the MIR to the CT scan and the need for chest tube drainage. We defined PTXs as clinically significant if they required a chest tube. Seventy-five patients were enrolled, with a mean age of 46 ± 16 years. Eighty-four percent were male. The screening test took approximately 1 minute. All but two patients had blunt chest trauma. Six true-positives, 6 false-positives, 63 true-negatives, and 0 false-negatives resulted in an overall sensitivity of 100%. MIR is an easy to use handheld technology that effectively screened patients for clinically significant PTXs, with a sensitivity and negative predictive value of 100%. MIR may be used for rapid, repeatable, and ongoing surveillance of trauma patients. Diagnostic study, level III.

Comparative psychology and the grand challenge of drug discovery in psychiatry and neurodegeneration.

PubMed

Brunner, Dani; Balcı, Fuat; Ludvig, Elliot A

2012-02-01

Drug discovery for brain disorders is undergoing a period of upheaval. Faced with an empty drug pipeline and numerous failures of potential new drugs in clinical trials, many large pharmaceutical companies have been shrinking or even closing down their research divisions that focus on central nervous system (CNS) disorders. In this paper, we argue that many of the difficulties facing CNS drug discovery stem from a lack of robustness in pre-clinical (i.e., non-human animal) testing. There are two main sources for this lack of robustness. First, there is the lack of replicability of many results from the pre-clinical stage, which we argue is driven by a combination of publication bias and inappropriate selection of statistical and experimental designs. Second, there is the frequent failure to translate results in non-human animals to parallel results in humans in the clinic. This limitation can only be overcome by developing new behavioral tests for non-human animals that have predictive, construct, and etiological validity. Here, we present these translational difficulties as a "grand challenge" to researchers from comparative cognition, who are well positioned to provide new methods for testing behavior and cognition in non-human animals. These new experimental protocols will need to be both statistically robust and target behavioral and cognitive processes that allow for better connection with human CNS disorders. Our hope is that this downturn in industrial research may represent an opportunity to develop new protocols that will re-kindle the search for more effective and safer drugs for CNS disorders. Copyright © 2011 Elsevier B.V. All rights reserved.

Estimating Preferences for Complex Health Technologies: Lessons Learned and Implications for Personalized Medicine.

PubMed

Marshall, Deborah A; Gonzalez, Juan Marcos; MacDonald, Karen V; Johnson, F Reed

2017-01-01

We examine key study design challenges of using stated-preference methods to estimate the value of whole-genome sequencing (WGS) as a specific example of genomic testing. Assessing the value of WGS is complex because WGS provides multiple findings, some of which can be incidental in nature and unrelated to the specific health concerns that motivated the test. In addition, WGS results can include actionable findings (variants considered to be clinically useful and can be acted on), findings for which evidence for best clinical action is not available (variants considered clinically valid but do not meet as high of a standard for clinical usefulness), and findings of unknown significance. We consider three key challenges encountered in designing our national study on the value of WGS-layers of uncertainty, potential downstream consequences with endogenous aspects, and both positive and negative utility associated with testing information-and potential solutions as strategies to address these challenges. We conceptualized the decision to acquire WGS information as a series of sequential choices that are resolved separately. To determine the value of WGS information at the initial decision to undergo WGS, we used contingent valuation questions, and to elicit respondent preferences for reducing risks of health problems and the consequences of taking the steps to reduce these risks, we used a discrete-choice experiment. We conclude by considering the implications for evaluating the value of other complex health technologies that involve multiple forms of uncertainty. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Clinical Utility of a Precision Medicine Test Evaluating Outpatients with Suspected Obstructive Coronary Artery Disease.

PubMed

Ladapo, Joseph A; Budoff, Matt; Sharp, David; Zapien, Michael; Huang, Lin; Maniet, Bruce; Herman, Lee; Monane, Mark

2017-04-01

Identifying patients with obstructive coronary artery disease can be challenging for primary care physicians. Advances in precision medicine may help augment clinical tools and redefine the paradigm for evaluating coronary artery disease in the outpatient setting. A blood-based age/sex/gene expression score (ASGES) incorporating key features of precision medicine has shown clinical validity with a 96% negative predictive value and 89% sensitivity in estimating a symptomatic patient's current likelihood of obstructive coronary artery disease. To better characterize the clinical utility of the ASGES and measure its impact on clinician decision-making, a community-based registry was established. The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients presenting with typical or atypical symptoms suggestive of obstructive coronary artery disease from 21 US primary care practices from August 2012 to August 2014. Demographics, clinical characteristics, and ASGES results (predefined as low [ASGES ≤15] or elevated [ASGES >15]) were collected, as were referrals to Cardiology or further functional/anatomic cardiac testing after ASGES testing. Patients were followed for 1 year post ASGES testing. Among the 566-patient cohort (median age 56 years), clinicians referred 26/252 (10%) of patients with low scores vs 137/314 (44%) of patients with elevated scores to Cardiology or advanced cardiac testing for further evaluation (unadjusted odds ratio 0.15, P <.0001; adjusted odds ratio after accounting for clinical covariates = 0.18, P <.0001). Data on 84 patients referred for advanced cardiac testing showed abnormal findings in 0 of 13 (0%) low ASGES and 10 of 71 (14%) elevated ASGES patients. Major adverse cardiovascular events and revascularization were noted in 3/252 (1.2%) patients with low ASGES and 14/314 (4.5%) patients with elevated ASGES score (P <.03). In this community-based cardiovascular registry, the ASGES demonstrated clinical utility in the evaluation of patients with suspected obstructive coronary artery disease. Low-score patients were less likely to undergo cardiac referral, were unlikely to have positive findings on further cardiac work-up, and had a low rate of adverse cardiovascular events in 1-year follow-up. Our work provides evidence supporting the value of using precision medicine in the delivery of cardiovascular care. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Patient Preferences Regarding Colorectal Cancer Screening: Test Features and Cost Willing to Pay Out of Pocket.

PubMed

Moreno, Courtney C; Weiss, Paul S; Jarrett, Thomas L; Roberts, David L; Mittal, Pardeep K; Votaw, John R

2016-01-01

The purpose of this investigation was to evaluate whether test features would make an individual more or less likely to undergo colorectal cancer screening and how much an individual would be willing to pay out of pocket for a screening test. The methods include an administration of a survey to consecutive adult patients of a general medicine clinic. The survey consisted of Likert-scale questions assessing the patients' likelihood of choosing a screening test based on various test characteristics. Additional questions measured the patients' age, race, gender, and maximum out-of-pocket cost they would be willing to pay. Chi-square tests were used to assess the associations between the likelihood questions and the various demographic characteristics. In results, survey response rate was 88.8% (213 of 240). Respondents were 48.4% female (103 of 213), 51.6% male (110 of 213), 82.6% White (176 of 213), 11.3% African-American (24 of 213), and 6.1% other (13 of 213). Risk of internal injury and light exposure to radiation were the least desirable test features. Light sedation was the only test feature that most respondents (54.8%) indicated would make them likely or very likely to undergo a colorectal cancer screening test. The vast majority of respondents (86.8%) were willing to pay less than $200 out of pocket for a colorectal cancer screening test. There was no statistically significant difference in the responses of males and females, or in the responses of individuals of different races or different ages regarding test features, or the amount individuals were willing to pay for a screening test. To conclude, survey results suggest that patient education emphasizing the low complication rate of computed tomographic colonography (CTC), the minimal risks associated with the low-level radiation exposure resulting from CTC, and the benefits of a sedation-free test (eg, no risk of sedation-related complication and no need for a driver) may increase patient acceptance of CTC. Additionally, an out-of-pocket cost of <$200 would be preferable from the patient perspective. Copyright © 2015 Mosby, Inc. All rights reserved.

Evidence for increased Chlamydia case finding after the introduction of rectal screening among women attending 2 Canadian sexually transmitted infection clinics.

PubMed

Gratrix, Jennifer; Singh, Ameeta E; Bergman, Joshua; Egan, Caroline; Plitt, Sabrina S; McGinnis, Justin; Bell, Christopher A; Drews, Steven J; Read, Ron

2015-02-01

Chlamydia trachomatis is the most common notifiable disease in Canada, and extragenital sites are believed to serve as hidden reservoirs for ongoing transmission of infection. There are no specific Canadian screening guidelines for asymptomatic individuals from extragenital sites. We sought to determine the prevalence and factors associated with rectal C. trachomatis among female sexually transmitted infection (STI) clinic attendees in Alberta, Canada. Between 20 July and 31 December 2012, all female attendees at 2 Provincial STI clinics receiving a pelvic examination, regardless of a history of anal intercourse, were screened for rectal C. trachomatis using the Gen-Probe Aptima COMBO 2 Assay. Demographic and behavior variables were compared between rectal-only chlamydia cases and genitourinary cases using χ(2) or Fisher exact test, Mann-Whitney test, and logistic regression. A total of 3055 women were screened for rectal chlamydia. The prevalence of rectal chlamydia ranged from 11.7% to 13.5%. There were 133 rectal-only cases, increasing case detection by 44.3% from 300 genitourinary cases to 433 total cases, ranging from 21.7% to 88.2% by clinic. Women who were a contact to an STI were less likely to have rectal-only chlamydia for both clinics (P ≤ .001). Our findings add to the growing body of evidence supporting universal rectal screening in high-risk women such as those undergoing pelvic exams at STI clinics. © The Author 2014. 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.

[Clinical characteristics among CABG or PCI which to treat chronic kidney disease with unprotected left main coronary artery disease].

PubMed

Pan, Yu; Qiu, Qi; Zhang, Yunting; Luo, Yawei; Yu, Xianpeng; He, Jiqiang; Li, Quan

2015-05-12

To explore the clinical characteristics and prognosis of patients with chronic kidney disease with unprotected left main (ULM) coronary artery disease undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). A total of 601 unprotected left main coronary artery disease patients were recruited. According to the values of endogenous creatinine clearance rate (Ccr), they were divided into three groups of <45 ml/min (n=40), 45-59 ml/min (n=96) and ≥60 ml/min (n=465). Retrospective comparisons were made for the clinical parameters and prognosis of ULM patients in different Ccr groups with different therapies. In Ccr≥60 ml/min group, the valves of left ventricular ejection fraction (LVEF) were lower in patients undergoing CABG. Patients with complete total occlusion (CTO) and complete revascularizations were much more than those undergoing PCI. In Ccr≥60 ml/min and Ccr 45-59 ml/min groups, multivessel disease was frequent in CABG-treated patients. No significant difference existed among three groups in major adverse cardiac and cerebrovascular event (MACCE), overall mortality or cardiac mortality. PCI is both safe and efficacious for chronic renal insufficiency patients with ULM.

Surgical treatment for women with breast cancer: do randomized clinical trials represent current medical practices?

PubMed

Frederick, Wayne A I; Ames, Sarah; Downing, Stephanie R; Oyetunji, Tolulope A; Chang, David C; Leffall, Lasalle D

2010-06-01

Randomized clinical trials have not shown survival differences between breast cancer patients who undergo breast-conserving surgery and those who undergo modified radical mastectomy (MRM). Recent studies however, have suggested that these randomized clinical trials findings may not be representative of the entire population or the nature of current patient care. A retrospective analysis of female invasive breast cancer patients who underwent surgery in the Surveillance, Epidemiology, and End Results database (1990-2003) was performed. Survival was compared amongst women who underwent partial mastectomy, partial mastectomy plus radiation (PMR), or MRM. Cox proportional hazards regressions were used to investigate the impact of method of treatment upon survival, after adjusting for patient and tumor characteristics. A total of 218,043 patients, mean age 62 years, were identified. MRM accounted for 51.5 per cent of the study population whereas PMR accounted for 34.9 per cent. On multivariate analyses, significant improvement was observed in patient survival associated with PMR when compared with MRM patients (hazard ratio = 0.71, 95% confidence interval = 0.67-0.74, P < 0.001). This population-based study suggests that there is a survival benefit for women undergoing PMR in the treatment of breast cancer.

Estimating the diagnostic accuracy of rheumatoid factor in UK primary care: a study using the Clinical Practice Research Datalink.

PubMed

Miller, Anne; Nightingale, Alison L; Sammon, Cormac J; Mahtani, Kamal R; Holt, Tim A; McHugh, Neil J; Luqmani, Raashid A

2015-10-01

To investigate the diagnostic accuracy of RF as a test for RA in primary care and its impact on referral times using the Clinical Practice Research Datalink. We identified all patients with a first RF test recorded in the Clinical Practice Research Datalink between 1 January 2000 and 31 December 2008 and those diagnosed with RA within 2 years of testing. We calculated likelihood ratios (LRs), sensitivity, specificity and predictive values of RF for a diagnosis of RA. We compared time to hospital referral in those testing positive and negative using Kaplan-Meier failure curves and log-rank tests. Of 62 436 first RF tests, 4679 (7.5%) were positive. There were 1753 incident cases of RA, of which 57.8% were seropositive. The positive LR for RF was 9.5 (95% CI 9.0, 10.0) and the negative LR was 0.5 (95% CI 0.4, 0.5). Sensitivity and specificity were 57.8% (95% CI 55.4%, 60.1%) and 93.9% (95% CI 93.7%, 94.1%) and the positive predictive value and negative predictive value were 21.4% (95% CI 20.3%, 22.6%) and 98.7% (95% CI 98.6%, 98.8%), respectively. Median time to first hospital contact after the first RF test in those with seropositive vs seronegative results was 54 days (95% CI 49, 58) vs 150 (95% CI 147, 152). Only 2.8% of patients undergoing RF testing were diagnosed with RA, suggesting that RF is used to screen patients with musculoskeletal symptoms rather than those with more specific features of RA. A positive RF test may be helpful in diagnosing RA in primary care but performs badly in excluding RA and may delay referral. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

The use of a pocket-sized ultrasound device improves physical examination: results of an in- and outpatient cohort study.

PubMed

Colli, Agostino; Prati, Daniele; Fraquelli, Mirella; Segato, Sergio; Vescovi, Pier Paolo; Colombo, Fabrizio; Balduini, Carlo; Della Valle, Serena; Casazza, Giovanni

2015-01-01

The performance of pocket mobile ultrasound devices (PUDs) is comparable with that of standard ultrasonography, whereas the accuracy of a physical examination is often poor requiring further tests to assess diagnostic hypotheses. Adding the use of PUD to physical examination could lead to an incremental benefit. We assessed whether the use of PUD in the context of physical examination can reduce the prescription of additional tests when used by physicians in different clinical settings. We conducted a cohort impact study in four hospital medical wards, one gastroenterological outpatient clinic, and 90 general practices in the same geographical area. The study involved 135 physicians who used PUD, after a short predefined training course, to examine 1962 consecutive patients with one of 10 diagnostic hypotheses: ascites, pleural effusion, pericardial effusion, urinary retention, urinary stones, gallstones, biliary-duct dilation, splenomegaly, abdominal mass, abdominal aortic aneurysm. According to the physicians' judgment, PUD examination could rule out or in the diagnostic hypothesis or require further testing; the concordance with the final diagnosis was assessed. The main outcome was the proportion of cases in which additional tests were required after PUD. The PUD diagnostic accuracy was assessed in patients submitted to further testing. The 1962 patients included 37% in-patients, 26% gastroenterology outpatients, 37% from general practices. Further testing after PUD examination was deemed unnecessary in 63%. Only 5% of patients with negative PUD not referred for further testing were classified false negatives with respect to the final diagnosis. In patients undergoing further tests, the sensitivity was 91%, and the specificity 83%. After a simple and short training course, a PUD examination can be used in addition to a physical examination to improve the answer to ten common clinical questions concerning in- and outpatients, and can reduce the need for further testing.

Safely diagnosing clinically significant penicillin allergy using only penicilloyl-poly-lysine, penicillin, and oral amoxicillin.

PubMed

Macy, Eric; Ngor, Eunis W

2013-01-01

Penicillin skin testing is rarely used to undiagnose penicillin "allergy" in the United States, partially because of concern that commercially available materials are inadequate. We determined whether skin testing with only commercially available penicilloyl-poly-lysine and penicillin followed by an oral amoxicillin challenge, if skin test-negative, can safely identify clinically significant penicillin allergy. Five hundred sequential persons with positive history of penicillin "allergy" were evaluated by skin testing with penicilloyl-poly-lysine and penicillin between June 8, 2010, and March 29, 2012. All persons with negative skin tests were given an oral amoxicillin challenge and observed for 1 hour. Persons undergoing penicillin allergy testing were representative of all health plan members with penicillin allergy. Only 4 persons (0.8%; 95% CI, 0.32%-2.03%) had a positive skin test result. Only 4 persons (0.8%; 95% CI, 0.32%-2.03%) had an acute objective oral amoxicillin challenge reaction. Fifteen persons (3.0%; 95% CI, 1.83%-4.98%) had subjective oral challenge reactions, either acute transient itching or dizziness. All were women and 11 (73.3%) had multiple drug intolerance syndrome. None had severe reactions or objective signs. These were not considered to be positive challenge reactions. Sixty-eight subjects (13.6%) who were negative on testing were exposed to 88 courses of penicillins during 90 days of follow-up. New reactions were reported after 4 courses (4.5%), 3 (75%) occurring in subjects with multiple drug intolerance syndrome. Penicillin skin testing, using only penicilloyl-poly-lysine and penicillin, followed by oral amoxicillin challenge, if negative, can safely identify clinically significant IgE-mediated penicillin allergy in patients who use health care in the United States at this time. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

A Posteriori Comparison of Natural and Surgical Destabilization Models of Canine Osteoarthritis

PubMed Central

Pelletier, Jean-Pierre; d'Anjou, Marc-André; Blond, Laurent; Pelletier, Johanne-Martel; del Castillo, Jérôme R. E.

2013-01-01

For many years Canis familiaris, the domestic dog, has drawn particular interest as a model of osteoarthritis (OA). Here, we optimized the dog model of experimental OA induced by cranial cruciate ligament sectioning. The usefulness of noninvasive complementary outcome measures, such as gait analysis for the limb function and magnetic resonance imaging for structural changes, was demonstrated in this model. Relationships were established between the functional impairment and the severity of structural changes including the measurement of cartilage thinning. In the dog model of naturally occurring OA, excellent test-retest reliability was denoted for the measurement of the limb function. A criterion to identify clinically meaningful responders to therapy was determined for privately owned dogs undergoing clinical trials. In addition, the recording of accelerometer-based duration of locomotor activity showed strong and complementary agreement with the biomechanical limb function. The translation potential of these models to the human OA condition is underlined. A preclinical testing protocol which combines the dog model of experimental OA induced by cranial cruciate ligament transection and the Dog model of naturally occurring OA offers the opportunity to further investigate the structural and functional benefits of disease-modifying strategies. Ultimately, a better prediction of outcomes for human clinical trials would be brought. PMID:24288664

Changes in Serial Optical Topography and TMS during Task Performance after Constraint-Induced Movement Therapy in Stroke: A Case Study

PubMed Central

Park, Si-Woon; Butler, Andrew J.; Cavalheiro, Vanessa; Alberts, Jay L.; Wolf, Steven L.

2013-01-01

The authors examined serial changes in optical topography in a stroke patient performing a functional task, as well as clinical and physiologic measures while undergoing constraint-induced therapy (CIT). A 73-year-old right hemiparetic patient, who had a subcortical stroke 4 months previously, received 2 weeks of CIT. During the therapy, daily optical topography imaging using near-infrared light was measured serially while the participant performed a functional key-turning task. Clinical outcome measures included the Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and functional key grip test. Transcranial magnetic stimulation (TMS) and functional magnetic resonance imaging (fMRI) were also used to map cortical areas and hemodynamic brain responses, respectively. Optical topography measurement showed an overall decrease in oxy-hemoglobin concentration in both hemispheres as therapy progressed and the laterality index increased toward the contralateral hemisphere. An increased TMS motor map area was observed in the contralateral cortex following treatment. Posttreatment fMRI showed bilateral primary motor cortex activation, although slightly greater in the contralateral hemisphere, during affected hand movement. Clinical scores revealed marked improvement in functional activities. In one patient who suffered a stroke, 2 weeks of CIT led to improved function and cortical reorganization in the hemisphere contralateral to the affected hand. PMID:15228805

Silent ischemia: silent after all?

PubMed

D'Antono, Bianca; Dupuis, Gilles; Arsenault, André; Burelle, Denis

2008-04-01

To examine the association of nonpain symptoms in men and women with exercise-related silent ischemia, as well as the independence of these findings from other clinical factors. A prospective study of 482 women and 425 men (mean age 58 years) undergoing exercise stress testing with myocardial perfusion imaging. Analyses were performed on 60 women and 155 men with no angina but medical perfusion imaging evidence of ischemia during exercise. The presence of various non-pain-related symptoms. Ischemia is indicated by myocardial perfusion defects on exercise stress testing with single photon emission computed tomography. Women reported more nonangina symptoms than men (P<0.05). They experienced fatigue, hot flushes, tense muscles, shortness of breath and headaches more frequently (P<0.05). Symptoms relating to muscle tension and diaphoresis were associated with ischemia after controlling for pertinent clinical covariates. However, the direction of association differed according to sex and history of coronary artery disease events or procedures. Sensitivity of the detection models showed modest improvements with the addition of these symptoms. While patients who experience silent ischemia experience a number of nonpain symptoms, those symptoms may not be sufficiently specific to ischemia, nor sensitive in detecting ischemia, to be of particular help to physicians in the absence of other clinical information.

"For all my family's sake, I should go and find out": an Australian report on genetic counseling and testing uptake in individuals at high risk of breast and/or ovarian cancer.

PubMed

Wakefield, Claire E; Ratnayake, Paboda; Meiser, Bettina; Suthers, Graeme; Price, Melanie A; Duffy, Jessica; Tucker, Kathy

2011-06-01

Despite proven benefits, the uptake of genetic counseling and testing by at-risk family members of BRCA1 and BRCA2 mutation carriers remains low. This study aimed to examine at-risk individuals' reported reasons for and against familial cancer clinic (FCC) attendance and genetic testing. Thirty-nine telephone interviews were conducted with relatives of high-risk mutation carriers, 23% (n = 9) of whom had not previously attended an FCC. Interview responses were analyzed using the frameworks of Miles and Huberman. The reasons most commonly reported for FCC attendance were for clarification of risk status and to gain access to testing. While disinterest in testing was one reason for FCC nonattendance, several individuals were unaware of their risk (n = 3) or their eligibility to attend an FCC (n = 2), despite being notified of their risk status through their participation in a large-scale research project. Individuals' reasons for undergoing testing were in line with that reported elsewhere; however, concerns about discrimination and insurance were not reported in nontestees. Current guidelines regarding notifying individuals discovered to be at increased risk in a research, rather than clinical setting, take a largely nondirective approach. However, this study demonstrates that individuals who receive a single letter notifying them of their risk may not understand/value the information they receive.

Outcomes after coronary computed tomography angiography in the emergency department: a systematic review and meta-analysis of randomized, controlled trials.

PubMed

Hulten, Edward; Pickett, Christopher; Bittencourt, Marcio Sommer; Villines, Todd C; Petrillo, Sara; Di Carli, Marcelo F; Blankstein, Ron

2013-02-26

The aim of the study was to systematically review and perform a meta-analysis of randomized, controlled trials of coronary computed tomography angiography (CCTA) versus usual care (UC) triage of acute chest pain in the emergency department (ED). CCTA allows rapid evaluation of patients presenting to the ED with acute chest pain syndromes; however, the impact of such testing on patient management and downstream testing has emerged as a concern. We systematically searched for randomized, controlled trials of CCTA in the ED and performed a meta-analysis of clinical outcomes. Four randomized, controlled trials were included, with 1,869 patients undergoing CCTA and 1,397 undergoing UC. There were no deaths and no difference in the incidence of myocardial infarction, post-discharge ED visits, or rehospitalizations. Four studies reported decreased length of stay with CCTA and 3 reported cost savings; 8.4% of patients undergoing CCTA versus 6.3% of those receiving UC underwent invasive coronary angiography (ICA), whereas 4.6% of patients undergoing CCTA versus 2.6% of those receiving UC underwent coronary revascularization. The odds ratio of ICA for CCTA patients versus UC patients was 1.36 (95% confidence interval [CI]: 1.03 to 1.80, p = 0.030), and for revascularization, it was 1.81 (95% CI: 1.20 to 2.72, p = 0.004). The absolute increase in ICA after CCTA was 21 per 1,000 CCTA patients (95% CI: 1.8 to 44.9), and the number needed to scan was 48. The absolute increase in revascularization after CCTA was 20 per 1,000 patients (95% CI: 5.0 to 41.4); the number needed to scan was 50. Both percutaneous coronary intervention and coronary artery bypass graft surgery independently contributed to the significant increase in revascularization. Compared with UC, the use of CCTA in the ED is associated with decreased ED cost and length of stay but increased ICA and revascularization. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS).

PubMed

Phibbs, Ciaran S; Love, Sean R; Jacobson, Alan K; Edson, Robert; Su, Pon; Uyeda, Lauren; Matchar, David B

2016-09-01

Effective management of patients using warfarin is resource-intensive, requiring frequent in-clinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST. To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency. In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly in-clinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up. PST and HQACM participants were similar with regard to gender, age, and CHADS2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per quality-adjusted life year gained with PST once weekly was $5566 (95 % CI, -$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions. Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis.

PubMed

Manheimer, Eric; Zhang, Grant; Udoff, Laurence; Haramati, Aviad; Langenberg, Patricia; Berman, Brian M; Bouter, Lex M

2008-03-08

To evaluate whether acupuncture improves rates of pregnancy and live birth when used as an adjuvant treatment to embryo transfer in women undergoing in vitro fertilisation. Systematic review and meta-analysis. Medline, Cochrane Central, Embase, Chinese Biomedical Database, hand searched abstracts, and reference lists. Review methods Eligible studies were randomised controlled trials that compared needle acupuncture administered within one day of embryo transfer with sham acupuncture or no adjuvant treatment, with reported outcomes of at least one of clinical pregnancy, ongoing pregnancy, or live birth. Two reviewers independently agreed on eligibility; assessed methodological quality; and extracted outcome data. For all trials, investigators contributed additional data not included in the original publication (such as live births). Meta-analyses included all randomised patients. Seven trials with 1366 women undergoing in vitro fertilisation were included in the meta-analyses. There was little clinical heterogeneity. Trials with sham acupuncture and no adjuvant treatment as controls were pooled for the primary analysis. Complementing the embryo transfer process with acupuncture was associated with significant and clinically relevant improvements in clinical pregnancy (odds ratio 1.65, 95% confidence interval 1.27 to 2.14; number needed to treat (NNT) 10 (7 to 17); seven trials), ongoing pregnancy (1.87, 1.40 to 2.49; NNT 9 (6 to 15); five trials), and live birth (1.91, 1.39 to 2.64; NNT 9 (6 to 17); four trials). Because we were unable to obtain outcome data on live births for three of the included trials, the pooled odds ratio for clinical pregnancy more accurately represents the true combined effect from these trials rather than the odds ratio for live birth. The results were robust to sensitivity analyses on study validity variables. A prespecified subgroup analysis restricted to the three trials with the higher rates of clinical pregnancy in the control group, however, suggested a smaller non-significant benefit of acupuncture (odds ratio 1.24, 0.86 to 1.77). Current preliminary evidence suggests that acupuncture given with embryo transfer improves rates of pregnancy and live birth among women undergoing in vitro fertilisation.

Disparities in staging prostate magnetic resonance imaging utilization for nonmetastatic prostate cancer patients undergoing definitive radiation therapy.

PubMed

Ajayi, Ayobami; Hwang, Wei-Ting; Vapiwala, Neha; Rosen, Mark; Chapman, Christina H; Both, Stefan; Shah, Meera; Wang, Xingmei; Agawu, Atu; Gabriel, Peter; Christodouleas, John; Tochner, Zelig; Deville, Curtiland

2016-01-01

There is growing evidence supporting incorporating multiparametric (mp) magnetic resonance imaging (MRI) scans into risk stratification, active surveillance, and treatment paradigms for prostate cancer. The purpose of our study was to determine whether demographic disparities exist in staging MRI utilization for prostate cancer patients. An institutional database of 705 nonmetastatic prostate cancer patients treated with radiation therapy from 2005 through 2013 was used to identify patients undergoing versus not undergoing pretreatment diagnostic prostate mpMRI. Uni- and multivariable logistic regression evaluated the relationship of clinical and demographic characteristics with MRI utilization. All demographic variables assessed, except the other race category, were significantly associated with MRI utilization (all P < .05), including age (odds ratio [OR], 0.92), black race (OR, 0.51), poverty (OR, 0.53), closer distance to radiation facility (OR, 1.79), and nonprivate primary insurance (OR, 0.57) on univariable analysis, while clinical stage T3 (OR, 3.37) was the only clinical characteristic. On multivariable analysis stratified by D'Amico risk group, age remained significant across all risk groups, whereas the black versus white racial (OR, 0.21; 95% confidence interval, 0.08-0.55) and nonprivate versus private insurance type (OR, 0.37; 95% confidence interval, 0.16-0.86) disparities persisted in the low-risk group. Clinical stage T3 remained associated in the high-risk group. For race specifically, the percentages of whites, blacks, and others undergoing MRI in the overall cohort and by risk group were, respectively: overall, 80% (343/427), 68% (156/231), and 85% (40/47); low risk, 86%, 56%, and 63%; intermediate risk, 79%, 72%, and 95%; and high risk, 72%, 72%, and 100%. In this urban, academic center cohort, older patients across all risk groups and black or nonprivate insurance patients in the low risk group were less likely to undergo staging prostate MRI scans. Further research should investigate these differences to ensure equitable utilization across all demographic groups considering the burden of prostate cancer disparities.

Increased Resistance of Skin Flora to Antimicrobial Prophylaxis in Patients Undergoing Hip Revision Arthroplasty.

PubMed

Mühlhofer, Heinrich M L; Deiss, Lukas; Mayer-Kuckuk, Philipp; Pohlig, Florian; Harrasser, Norbert; Lenze, Ulrich; Gollwitzer, Hans; Suren, Christian; Prodinger, Peter; VON Eisenhart-Rothe, Rüdiger; Schauwecker, Johannes

2017-01-01

Prosthetic joint infection (PJI) remains a major complication after total joint replacement and is the primary indication for revision arthroplasty. Specifically, coagulase-negative Staphylococci (CNS) can cause low-grade infections. Despite the use of cephalosporin-based antimicrobial prophylaxis (AMP) and antiseptic treatment at the surgical site, evidence suggests that a significant number of cases of dermal CNS results in low-grade PJI. Thus, this study examined the bacterial colonization and resistance patterns at the surgical site. We hypothesized that the bacteria developed resistance to antibiotics that are frequently used in primary and revision total hip arthroplasty (THA) procedures. Ninety patients, including 63 primary and 27 revision THA patients, were enrolled in this study. For each patient, a single swab of the skin at the surgical site was subjected to clinical microbiology to assess bacterial colonization. Furthermore, resistance to a sentinel panel of antibiotics (benzylpenicillin, erythromycin, tetracycline, oxacillin, fusidic acid, clindamycin, gentamicin, levofloxacin/moxifloxacin, rifampicin, linezolid and vancomycin) was tested. In 96.7% of the patients, at least one bacterial strain was identified at the surgical site, with CNS strains comprising 93.1% of the total. The sentinel panel showed that 30.7% of the CNS strains exhibited maximal resistance to oxacillin, a commonly used cephalosporin. Additionally, oxacillin resistance increased 1.9-fold (p=0.042) between primary and revision THA. Notably, 8.1% of the CNS stains found on patients undergoing primary THA were resistant to gentamicin, an aminoglycoside, and this rate increased 4.7-fold (p=0.001) for patients undergoing revision THA. CNS strains have significant resistance to standard AMP, particularly in individuals undergoing revision THA. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Home cage wheel running is an objective and clinically relevant method to assess inflammatory pain in male and female rats

PubMed Central

Kandasamy, Ram; Calsbeek, Jonas J.; Morgan, Michael M.

2016-01-01

Background The assessment of nociception in preclinical studies is undergoing a transformation from pain-evoked to pain-depressed tests to more closely mimic the effects of clinical pain. Many inflammatory pain-depressed behaviors (reward seeking, locomotion) have been examined, but these tests are limited because of confounds such as stress and difficulties in quantifying behavior. New Method The present study evaluates home cage wheel running as an objective method to assess the magnitude and duration of inflammatory pain in male and female rats. Results Injection of Complete Freund’s Adjuvant (CFA) into the right hindpaw to induce inflammatory pain almost completely inhibited wheel running for 2 days in males and females. Wheel running gradually returned to baseline levels within 12 days despite persistent mechanical hypersensitivity (von Frey test). Comparison with Existing Methods Continuously monitoring home cage wheel running improves on previous studies examining inflammatory pain-depressed wheel running because it is more sensitive to noxious stimuli, avoids the stress of removing the rat from its cage for testing, and provides a complete analysis of the time course for changes in nociception. Conclusions The present data indicate that home cage wheel running is a clinically relevant method to assess inflammatory pain in the rat. The decrease in activity caused by inflammatory pain and subsequent gradual recovery mimics the changes in activity caused by pain in humans. The tendency for pain-depressed wheel running to be greater in female than male rats is consistent with the tendency for women to be at greater risk of chronic pain than men. PMID:26891874

HIV/STD pattern and its associated risk factors among male STD clinic attendees in China: a foci for HIV intervention

PubMed Central

2011-01-01

Background Previous studies suggested a high prevalence of STDs including HIV among female sex workers and men who have sex with men in China, but little was known about the prevalence in male patients attending public STD clinics. The aim of this study was to investigate STD patterns and HIV prevalence among male STD clinic attendees in different areas in China and the associated risk factors. The feasibility of Provider-initiated HIV testing and counseling (PITC) was evaluated as well. Methods A cross-sectional study was conducted at 46 public STD clinics in 4 provinces in China. Between July 2009 and September 2009, a total of 3243 eligible subjects were invited to participate in an interview with a structured-questionnaire for collecting socio-demographic characteristics and sexual behavioral information. They also were asked to provide venous blood samples for serological determinations of HIV and syphilis infection, and first void urine specimens for detecting Chlamydia trachomatis and Neisseria gonorrhoeae infections, Results Out of the 3243 eligible patients, 2951(91%) men agreed to take part in the HIV and syphilis testing. The overall prevalence rate of HIV infection was 0.7% while the rates of syphilis, N. gonorrhoeae, C. trachomatis infections were 10.7%, 4.3% and 6.9%, respectively, with the highest syphilis and N. gonorrhoeae rates in Jiangsu Province. Patients from Guangxi province, homosexual/bisexual practices and intravenous drug use were significantly associated with HIV infection in multivariate logistic regression analyses. Provider-initiated HIV testing and counseling (PITC) was well accepted by attendees, with 91% of eligible attendees agreeing to undergo HIV testing and counseling. All HIV positive patients were properly managed accordingly. Conclusions A modest prevalence of HIV infection and substantial prevalence of other STD infections were found among male patients attending public STD clinics in China. The findings further support the introduction of HIV and syphilis PITC strategy into this important setting. PMID:22200257

HIV/STD pattern and its associated risk factors among male STD clinic attendees in China: a foci for HIV intervention.

PubMed

Wang, Qian-Qiu; Chen, Xiang-Sheng; Yin, Yue-Ping; Liang, Guo-Jun; Jiang, Ning; Dai, Ting; Huan, Xi-Ping; Yang, Bing; Liu, Qiao; Zhou, Yu-Jiao; Wang, Bao-Xi

2011-12-26

Previous studies suggested a high prevalence of STDs including HIV among female sex workers and men who have sex with men in China, but little was known about the prevalence in male patients attending public STD clinics. The aim of this study was to investigate STD patterns and HIV prevalence among male STD clinic attendees in different areas in China and the associated risk factors. The feasibility of Provider-initiated HIV testing and counseling (PITC) was evaluated as well. A cross-sectional study was conducted at 46 public STD clinics in 4 provinces in China. Between July 2009 and September 2009, a total of 3243 eligible subjects were invited to participate in an interview with a structured-questionnaire for collecting socio-demographic characteristics and sexual behavioral information. They also were asked to provide venous blood samples for serological determinations of HIV and syphilis infection, and first void urine specimens for detecting Chlamydia trachomatis and Neisseria gonorrhoeae infections, Out of the 3243 eligible patients, 2951(91%) men agreed to take part in the HIV and syphilis testing. The overall prevalence rate of HIV infection was 0.7% while the rates of syphilis, N. gonorrhoeae, C. trachomatis infections were 10.7%, 4.3% and 6.9%, respectively, with the highest syphilis and N. gonorrhoeae rates in Jiangsu Province. Patients from Guangxi province, homosexual/bisexual practices and intravenous drug use were significantly associated with HIV infection in multivariate logistic regression analyses. Provider-initiated HIV testing and counseling (PITC) was well accepted by attendees, with 91% of eligible attendees agreeing to undergo HIV testing and counseling. All HIV positive patients were properly managed accordingly. A modest prevalence of HIV infection and substantial prevalence of other STD infections were found among male patients attending public STD clinics in China. The findings further support the introduction of HIV and syphilis PITC strategy into this important setting.

Replacement of aprotinin by ε-aminocaproic acid in infants undergoing cardiac surgery: consequences for blood loss and outcome.

PubMed

Martin, K; Gertler, R; MacGuill, M; Mayr, N P; Hapfelmeier, A; Hörer, J; Vogt, M; Tassani, P; Wiesner, G

2013-04-01

Once aprotinin was no longer available for clinical use, ε-aminocaproic acid (EACA) and tranexamic acid became the only two options for antifibrinolytic therapy. We compared aprotinin and EACA with respect to their blood-sparing efficacy and other major clinical outcome criteria in infants undergoing cardiac surgery. We retrospectively analysed data from a large consecutive cohort of infants (n=227) aged 31-365 days undergoing primary cardiac surgery requiring cardiopulmonary bypass encompassing the transition from aprotinin to EACA (aprotinin n=88, EACA n=139); all other aspects including the medical team and departmental protocols remained unchanged. The primary outcome was postoperative blood loss measured as chest tube output (CTO). Secondary outcome parameters were transfusion requirements, reoperation due to bleeding, renal, vascular, and neurological complications, and in-hospital mortality. CTO was significantly higher in the EACA patients {aprotinin 18 (13-27) ml kg(-1) 24 h(-1), EACA 23 (15-37) ml kg(-1) 24 h(-1) [mean (inter-quartile range)], P=0.001}, but transfusion requirements and donor exposures were not significantly different. A sensitivity analysis strengthened our finding that the increased blood loss in the EACA group was attributable to lower efficacy of EACA. There were no significant differences in the other clinical outcome measures. CTO was lower in aprotinin-treated patients. Nonetheless, EACA remains a suitable substitute without measurable differences in other clinical outcome criteria.

Incentive spirometry in postoperative abdominal/thoracic surgery patients.

PubMed

Rupp, Michael; Miley, Helen; Russell-Babin, Kathleen

2013-01-01

Postoperative patients have higher incidences of respiratory complications. Patients undergoing abdominal or thoracic surgical procedures are at greater risk of having such complications. Incentive spirometry is an inhalation-based prophylactic technique that encourages patients to mimic a natural deep sigh to periodically increase lung volume. As this technique is the prophylactic method of choice for many hospitals, several studies have tested its efficacy. Five articles, including 4 systematic reviews and 1 clinical practice guideline, are analyzed and summarized. Each article was reviewed by a multidisciplinary team of health care providers and is discussed herein. A clinical recommendation for practice change is provided on the basis of the results. Incentive spirometry is only as effective as cough/deep-breathing regimens and other means of postoperative pulmonary prophylaxis. No single prophylactic technique clearly outperforms all others in preventing pulmonary complications. Future research is needed to determine the best method to prevent postoperative pulmonary complications.

Broad-spectrum antibacterial properties of metal-ion doped borate bioactive glasses for clinical applications

NASA Astrophysics Data System (ADS)

Ottomeyer, Megan

Bioactive glasses with antimicrobial properties can be implemented as coatings on medical devices and implants, as well as a treatment for tissue repair and prevention of common hospital-acquired infections such as MRSA. A borate-containing glass, B3, is also undergoing clinical trials to assess wound-healing properties. The sensitivities of various bacteria to B3, B3-Ag, B3-Ga, and B3-I bioactive glasses were tested. In addition, the mechanism of action for the glasses was studied by spectroscopic enzyme kinetics experiments, Live-Dead staining fluorescence microscopy, and luminescence assays using two gene fusion strains of Escherichia coli. It was found that gram-positive bacteria were more sensitive to all four glasses than gram negative bacteria, and that a single mechanism of action for the glasses is unlikely, as the rates of catalysis for metabolic enzymes as well as membrane permeability were altered after glass exposure.

Genetic risk assessment for women with epithelial ovarian cancer: referral patterns and outcomes in a university gynecologic oncology clinic.

PubMed

Petzel, Sue V; Vogel, Rachel Isaksson; Bensend, Tracy; Leininger, Anna; Argenta, Peter A; Geller, Melissa A

2013-10-01

Little is known about genetic service utilization and ovarian cancer. We identified the frequency and outcome of genetic counseling referral, predictors of referral, and referral uptake for ovarian cancer patients. Using pathology reports, we identified all epithelial ovarian cancer patients seen in a university gynecologic oncology clinic (1/04-8/06). Electronic medical records (EMR) were used to document genetic service referral, time from diagnosis-to-referral, point-in-treatment at referral, personal/family cancer history, demographics, and genetic test results. Groups were compared using chi-squared and Fisher's exact test for categorical variables and t-tests for continuous variables. The study population consisted of 376 women with ovarian cancer, 72 (19 %) of who were referred for genetic counseling/testing, primarily during surveillance. Of those referred, 42 (58 %) had personal or family genetic counseling and 34 (47 %) were ultimately tested or identified due to known family mutation. Family history and prior cancer were associated with referral. Family history, living in a larger community, higher-stage disease, and serous histology were associated with undergoing genetic counseling. Risk assessment identified 20 BRCA1/2 (5.3 %) and 1 HNPCC (0.3 %) mutation carriers. Based on recent estimates that 11.7-16.6 % of women with ovarian cancer are BRCA carriers and 2 % are HNPCC carriers, results suggest under-identification of carriers and under-utilization of genetic services by providers and patients. Interventions to increase medical providers' referrals, even in a specialized oncology clinic, are necessary and may include innovations in educating these providers using web-based methods. Ease of referral by the introduction of an electronic cancer genetic referral form represents another new direction that may increase genetic risk assessment for high-risk women with ovarian cancer.

Comparative clinical utility of tumor genomic testing and cell-free DNA in metastatic breast cancer.

PubMed

Maxwell, Kara N; Soucier-Ernst, Danielle; Tahirovic, Emin; Troxel, Andrea B; Clark, Candace; Feldman, Michael; Colameco, Christopher; Kakrecha, Bijal; Langer, Melissa; Lieberman, David; Morrissette, Jennifer J D; Paul, Matt R; Pan, Tien-Chi; Yee, Stephanie; Shih, Natalie; Carpenter, Erica; Chodosh, Lewis A; DeMichele, Angela

2017-08-01

Breast cancer metastases differ biologically from primary disease; therefore, metastatic biopsies may assist in treatment decision making. Commercial genomic testing of both tumor and circulating tumor DNA have become available clinically, but utility of these tests in breast cancer management remains unclear. Patients undergoing a clinically indicated metastatic tumor biopsy were consented to the ongoing METAMORPH registry. Tumor and blood were collected at the time of disease progression before subsequent therapy, and patients were followed for response on subsequent treatment. Tumor testing (n = 53) and concurrent cell-free DNA (n = 32) in a subset of patients was performed using CLIA-approved assays. The proportion of patients with a genomic alteration was lower in tumor than in blood (69 vs. 91%; p = 0.06). After restricting analysis to alterations covered on both platforms, 83% of tumor alterations were detected in blood, while 90% of blood alterations were detected in tumor. Mutational load specific for the panel genes was calculated for both tumor and blood. Time to progression on subsequent treatment was significantly shorter for patients whose tumors had high panel-specific mutational load (HR 0.31, 95% CI 0.12-0.78) or a TP53 mutation (HR 0.35, 95% CI 0.20-0.79), after adjusting for stage at presentation, hormone receptor status, prior treatment type, and number of lines of metastatic treatment. Treating oncologists must distinguish platform differences from true biological heterogeneity when comparing tumor and cfDNA genomic testing results. Tumor and concurrent cfDNA contribute unique genomic information in metastatic breast cancer patients, providing potentially useful biomarkers for aggressive metastatic disease.

Full-course drug challenge test in the diagnosis of delayed allergic reactions to penicillin.

PubMed

Borch, Jakob E; Bindslev-Jensen, Carsten

2011-01-01

Drug challenge test (DCT) has long been the most sensitive test in the allergological work-up when investigating for penicillin allergy. To improve sensitivity of the diagnostic work-up in diagnosing penicillin allergics with histories of allergic reactions on day 2 or later in the course of penicillin treatment. A full-course DCT was added to the current protocol if specific IgE, skin tests and DCT were all negative in patients who had a nonimmediate reaction to penicillin treatment. Sixteen patients with a history of an immediate reaction to penicillin treatment underwent testing with negative outcomes. Fifty percent of patients undergoing full-course DCT experienced a cutaneous adverse drug reaction. None of the controls reacted (p = 0.001). The mean time of reaction was 6 days. Penicillin V accounted for most reactions. Urticaria was the most frequent clinical reaction observed. Full-course DCT offers an improvement of sensitivity and predictive values of the diagnostic work-up of allergic reactions to penicillin occurring on day 2 of penicillin treatment or later. Copyright © 2011 S. Karger AG, Basel.

HEMATOPOIETIC PROGENITOR CELL CONTENT OF VERTEBRAL BODY MARROW USED FOR COMBINED SOLID ORGAN AND BONE MARROW TRANSPLANTATION

PubMed Central

Rybka, Witold B.; Fontes, Paulo A.; Rao, Abdul S.; Winkelstein, Alan; Ricordi, Camillo; Ball, Edward D.; Starzl, Thomas E.

2010-01-01

While cadaveric vertebral bodies (VB) have long been proposed as a suitable source of bone marrow (BM) for transplantation (BMT), they have rarely been used for this purpose. We have infused VB BM immediately following whole organ (WO) transplantation to augment donor cell chimerism. We quantified the hematopoietic progenitor cell (HPC) content of VB BM as well as BM obtained from the iliac crests (IC) of normal allogeneic donors (ALLO) and from patients with malignancy undergoing autologous marrow harvest (AUTO). Patients undergoing WOIBM transplantation also had AUTO BM harvested in the event that subsequent lymphohematopoietic reconstitution was required. Twenty-four VB BM, 24 IC BM-ALLO, 31 IC AUTO, and 24 IC WO-AUTO were harvested. VB BM was tested 12 to 72 hr after procurement and infused after completion ofWO grafting. IC BM was tested and then used or cryopreserved immediately. HPC were quantified by clonal assay measuring CFU-GM, BFU-E, and CFU-GEMM, and by flow cytometry for CD34+ progenitor cells. On an average, 9 VB were processed during each harvest, and despite an extended processing time the number of viable nucleated cells obtained was significantly higher than that from IC. Furthermore, by HPC content, VB BM was equivalent to IC BM, which is routinely used for BMT. We conclude that VB BM is a clinically valuable source of BM for allogeneic transplantation. PMID:7701582

The effects of supine and prone positions on oxygenation in premature infants undergoing mechanical ventilation

PubMed Central

Abdeyazdan, Zahra; Nematollahi, Monirosadat; Ghazavi, Zohreh; Mohhamadizadeh, Majid

2010-01-01

BACKGROUND: Since the use of high concentrations of oxygen in infants may lead to chronic lung problems, using proper methods of care in infants under mechanical ventilation is one of the most important measures in NICU. This study aimed to investigate the effects of prone and supine positions on oxygenation (SPO2) in premature infants under mechanical ventilation and comparing infants’ oxygenation in the two positions. METHODS: In across over non randomized clinical trial study, 32 preterm infants under mechanical ventilation who had inclusion criteria were enrolled in simple convenient method. Firstly, they were placed in supine position for 120 minutes and further in prone position for 120 minutes .Their SPO2 were monitored by pulse oximeter continuously and was recorded every minute. Data analysis was done using Software SPSS15 by ANOVA test and post hoc test. RESULTS: The data showed that during 120 minutes of exposure of infants in each position there were no significant changes in SPO2. In addition, the SPO2 levels in the prone position were significantly higher than the SPO2 levels in the supine position from 15th minute to 120th minute (to the end). CONCLUSIONS: Neonatal positioning in prone position is a simple, non-invasive, and free of charge method that could lead to improve oxygenation in infants undergoing mechanical ventilation. PMID:22049286

Drug resistance of Mycobacterium tuberculosis in Malawi: a cross-sectional survey

PubMed Central

Abouyannis, Michael; Dacombe, Russell; Dambe, Isaias; Mpunga, James; Faragher, Brian; Gausi, Francis; Ndhlovu, Henry; Kachiza, Chifundo; Suarez, Pedro; Mundy, Catherine; Banda, Hastings T; Nyasulu, Ishmael

2014-01-01

Abstract Objective To document the prevalence of multidrug resistance among people newly diagnosed with – and those retreated for – tuberculosis in Malawi. Methods We conducted a nationally representative survey of people with sputum-smear-positive tuberculosis between 2010 and 2011. For all consenting participants, we collected demographic and clinical data, two sputum samples and tested for human immunodeficiency virus (HIV).The samples underwent resistance testing at the Central Reference Laboratory in Lilongwe, Malawi. All Mycobacterium tuberculosis isolates found to be multidrug-resistant were retested for resistance to first-line drugs – and tested for resistance to second-line drugs – at a Supranational Tuberculosis Reference Laboratory in South Africa. Findings Overall, M. tuberculosis was isolated from 1777 (83.8%) of the 2120 smear-positive tuberculosis patients. Multidrug resistance was identified in five (0.4%) of 1196 isolates from new cases and 28 (4.8%) of 581 isolates from people undergoing retreatment. Of the 31 isolates from retreatment cases who had previously failed treatment, nine (29.0%) showed multidrug resistance. Although resistance to second-line drugs was found, no cases of extensive drug-resistant tuberculosis were detected. HIV testing of people from whom M. tuberculosis isolates were obtained showed that 577 (48.2%) of people newly diagnosed and 386 (66.4%) of people undergoing retreatment were positive. Conclusion The prevalence of multidrug resistance among people with smear-positive tuberculosis was low for sub-Saharan Africa – probably reflecting the strength of Malawi’s tuberculosis control programme. The relatively high prevalence of such resistance observed among those with previous treatment failure may highlight a need for a change in the national policy for retreating this subgroup of people with tuberculosis. PMID:25378741

Metastatic Pheochromocytoma/Paraganglioma Related to Primary Tumor Development in Childhood or Adolescence: Significant Link to SDHB Mutations

PubMed Central

King, Kathryn S.; Prodanov, Tamara; Kantorovich, Vitaly; Fojo, Tito; Hewitt, Jacqueline K.; Zacharin, Margaret; Wesley, Robert; Lodish, Maya; Raygada, Margarita; Gimenez-Roqueplo, Anne-Paule; McCormack, Shana; Eisenhofer, Graeme; Milosevic, Dragana; Kebebew, Electron; Stratakis, Constantine A.; Pacak, Karel

2011-01-01

Purpose To present data on the high rate of SDHB mutations in patients with metastatic pheochromocytoma/paraganglioma whose initial tumor presentation began in childhood or adolescence. Patients and Methods From 2000 to 2010, 263 patients with pheochromocytoma/paraganglioma were evaluated through the National Institutes of Health (NIH), Bethesda, MD. Of the 263 patients, 125 patients were found to have metastatic disease; of these 125 patients, 32 patients presented with a tumor before 20 years of age. An additional 17 patients presented with a tumor before 20 years of age but demonstrated no development of metastatic disease. Genetic testing for mutations in the VHL, MEN, and SDHB/C/D genes was performed on patients without previously identified genetic mutations. Results Of the 32 patients who presented with metastatic disease and had their primary tumor in childhood or adolescence, sequence analysis of germline DNA showed SDHB mutations in 23 patients (71.9%), SDHD mutations in three patients (9.4%), VHL mutations in two patients (6.3%), and an absence of a known mutation in four patients (12.5%). The majority of these 32 patients (78.1%) presented with primary tumors in an extra-adrenal location. Conclusion The majority of patients with metastatic pheochromocytoma/paraganglioma who presented with a primary tumor in childhood/adolescence had primary extra-adrenal tumors and harbored SDHB mutations. Except for primary tumors located in the head and neck where SDHD genetic testing is advised, we recommend that patients who present with metastatic pheochromocytoma/paraganglioma with primary tumor development in childhood or adolescence undergo SDHB genetic testing before they undergo testing for other gene mutations, unless clinical presentation or family history suggests a different mutation. PMID:21969497

Perioperative Near-Infrared Spectroscopy Monitoring in Neonates With Congenital Heart Disease: Relationship of Cerebral Tissue Oxygenation Index Variability With Neurodevelopmental Outcome.

PubMed

Spaeder, Michael C; Klugman, Darren; Skurow-Todd, Kami; Glass, Penny; Jonas, Richard A; Donofrio, Mary T

2017-03-01

To evaluate the value of perioperative cerebral near-infrared spectroscopy monitoring using variability analysis in the prediction of neurodevelopmental outcomes in neonates undergoing surgery for congenital heart disease. Retrospective cohort study. Urban, academic, tertiary-care children's hospital. Neonates undergoing surgery with cardiopulmonary bypass for congenital heart disease. Perioperative monitoring of continuous cerebral tissue oxygenation index by near-infrared spectroscopy and subsequent neurodevelopmental testing at 6, 15, and 21 months of age. We developed a new measure, cerebral tissue oxygenation index variability, using the root mean of successive squared differences of averaged 1-minute cerebral tissue oxygenation index values for both the intraoperative and first 24-hours postoperative phases of monitoring. There were 62 neonates who underwent cerebral tissue oxygenation index monitoring during surgery for congenital heart disease and 44 underwent subsequent neurodevelopmental testing (12 did not survive until testing and six were lost to follow-up). Among the 44 monitored patients who underwent neurodevelopmental testing, 20 (45%) had abnormal neurodevelopmental indices. Patients with abnormal neurodevelopmental indices had lower postoperative cerebral tissue oxygenation index variability when compared with patients with normal indices (p = 0.01). Adjusting for class of congenital heart disease and duration of deep hypothermic circulatory arrest, lower postoperative cerebral tissue oxygenation index variability was associated with poor neurodevelopmental outcome (p = 0.02). We found reduced postoperative cerebral tissue oxygenation index variability in neonatal survivors of congenital heart disease surgery with poor neurodevelopmental outcomes. We hypothesize that reduced cerebral tissue oxygenation index variability may be a surrogate for impaired cerebral metabolic autoregulation in the immediate postoperative period. Further research is needed to investigate clinical implications of this finding and opportunities for using this measure to drive therapeutic interventions.

Driving performance of stable outpatients with depression undergoing real-world treatment.

PubMed

Miyata, Akemi; Iwamoto, Kunihiro; Kawano, Naoko; Aleksic, Branko; Ando, Masahiko; Ebe, Kazutoshi; Fujita, Kiyoshi; Yokoyama, Motonori; Akiyama, Tsuyoshi; Igarashi, Yoshio; Ozaki, Norio

2018-06-01

Although the effects of psychotropics on driving ability have received much attention, little research is available on driving performance of stable outpatients with depression undergoing real-world treatment. This observational study investigated driving performance, cognitive functions, and depressive symptomatology of partly remitted outpatients with depression under daily-practice psychopharmacologic treatment. Seventy stable outpatients with depression and 67 healthy volunteers were enrolled. Patients' prescriptions were not controlled in order to capture the real-world treatment environment. Participants underwent three driving tasks - road-tracking, car-following, and harsh-braking - using a driving simulator, and three cognitive tasks - Continuous Performance Test, Wisconsin Card Sorting Test, and Trail-Making Test. The Symptom Assessment Scale - Structured Interview Guide for the Hamilton Depression Rating Scale, Beck Depression Inventory-II, Social Adaptation Self-Evaluation Scale, and Stanford Sleepiness Scale were also completed. Although many patients received various pharmacologic treatments, there were no significant differences in the three driving tasks between outpatients with depression and healthy controls. Difficulty of maintaining set in the Wisconsin Card Sorting Test was significantly increased in patients with depression. Results on the Social Adaptation Self-Evaluation Scale were significantly associated with road-tracking and car-following performance, in contrast to results on the Hamilton Depression Rating Scale and the Beck Depression Inventory-II. We conclude that partly remitted depressive patients under steady-state pharmacologic treatment do not differ from healthy controls with respect to driving performance, which seems to be more affected by psychosocial functioning than by pharmacologic agents. This, however, should be investigated systematically in an off/on study. © 2018 The Authors. Psychiatry and Clinical Neurosciences © 2018 Japanese Society of Psychiatry and Neurology.

Attitudes of Patients With Cancer About Personalized Medicine and Somatic Genetic Testing

PubMed Central

Gray, Stacy W.; Hicks-Courant, Katherine; Lathan, Christopher S.; Garraway, Levi; Park, Elyse R.; Weeks, Jane C.

2012-01-01

Purpose: Dramatic advances in genomic technology stand to revolutionize cancer care; however, little is known about patients' understanding and acceptance of personalized medicine and widespread genetic testing (GT). Patients and Methods: We conducted a formative, semi-structured interview study with a random sample of patients with lung, colorectal, and breast cancers to assess awareness of personalized medicine and GT and attitudes about somatic GT. Willingness to undergo GT was elicited through hypothetic scenarios. Results: Sixty-nine patients participated; 71% were women; 42% were black; median age was 59 years; and 42% had an education level ≥ college. We found that a majority of patients either were not aware of the term “personalized medicine” or defined it in unexpected ways. Although many patients identified relevant benefits of somatic testing (eg, informs treatment), many patients also expressed significant concerns (ie, psychological harm and discrimination). A majority of patients expressed a willingness to undergo somatic (predictive, 96%, prognostic, 93%) and germline (cancer risk without incidental information, 87%; cancer risk with incidental information, 81%; pharmacogenetic, 91%) testing; however, far fewer patients expressed a willingness to undergo full genome sequencing (62%). Reluctance was attributed to concerns over incidental findings, information overload, and the lack of a clear benefit. Conclusion: Many patients relayed misunderstandings about somatic testing and a reluctance to undergo full sequencing; oncologists must carefully consider how they present testing to patients so that concerns over discrimination and psychological harm do not hinder test uptake. More work is needed to identify effective ways to communicate complex genomic concepts to patients and research participants. PMID:23598841

Vitamin D and assisted reproductive treatment outcome: a systematic review and meta-analysis.

PubMed

Chu, Justin; Gallos, Ioannis; Tobias, Aurelio; Tan, Bee; Eapen, Abey; Coomarasamy, Arri

2018-01-01

Is serum vitamin D associated with live birth rates in women undergoing ART? Women undergoing ART who are replete in vitamin D have a higher live birth rate than women who are vitamin D deficient or insufficient. Vitamin D deficiency has been associated with an increased risk of abnormal pregnancy implantation as well as obstetric complications such as pre-eclampsia and fetal growth restriction. However, the effect of vitamin D on conception and early pregnancy outcomes in couples undergoing ART is poorly understood. A systematic review and meta-analysis of 11 published cohort studies (including 2700 women) investigating the association between vitamin D and ART outcomes. Literature searches were conducted to retrieve studies which reported on the association between vitamin D and ART outcomes. Databases searched included MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and CINAHL. Eleven studies matched the inclusion criteria. Live birth was reported in seven of the included studies (including 2026 patients). Live birth was found to be more likely in women replete in vitamin D when compared to women with deficient or insufficient vitamin D status (OR 1.33 [1.08-1.65]). Five studies (including 1700 patients) found that women replete in vitamin D were more likely to achieve a positive pregnancy test than women deficient or insufficient in vitamin D (OR 1.34 ([1.04-1.73]). All 11 of the included studies (including 2700 patients) reported clinical pregnancy as an outcome. Clinical pregnancy was found to be more likely in women replete in vitamin D (OR 1.46 [1.05-2.02]). Six studies (including 1635 patients) reported miscarriage by vitamin D concentrations. There was no association found between miscarriage and vitamin D concentrations (OR 1.12 [0.81-1.54]. The included studies scored well on the Newcastle-Ottawa quality assessment scale. Although strict inclusion criteria were used in the conduct of the systematic review, the included studies are heterogeneous in population characteristics and fertility treatment protocols. The findings of this systematic review show that there is an association between vitamin D status and reproductive treatment outcomes achieved in women undergoing ART. Our results show that vitamin D deficiency and insufficiency could be important conditions to treat in women considering ARTs. A randomized controlled trial to investigate the benefits of vitamin D deficiency treatment should be considered to test this hypothesis. No external funding was either sought or obtained for this study. The authors have no competing interests to declare. N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Recent developments of cyclotron produced radionuclides for nuclear cardiology

NASA Astrophysics Data System (ADS)

Kulkarni, P. V.; Jansen, D. E.; Corbett, J. R.

1987-04-01

For over a decade myocardial perfusion imaging with thallium-201, a cyclotron product, has been routinely used in clinical medicine. Recent advances have allowed the efficient production of very high purity (> 99.8%) iodine-123. New metabolically active 123I labeled radiopharmaceuticals, including alkyl and phenyl fatty acids, and norepinephrine analogs, have been developed and are undergoing clinical trials. Fab' fragments of monoclonal antibodies to cardiac myosin have been labeled with indium-111 ( 111In) and are undergoing clinical evaluation for imaging myocardial infarcts. Monoclonal antibodies to platelets, fibrin, and the thrombolytic agent, tissue plasminogen activator (TPA), have recently been labeled with 111In. Together these developments in radiotracers and instrumentation should have a significant impact on the future of cardiovascular nuclear medicine. This manuscript will discuss developments in single photon emitting radiotracers for myocardial imaging.

Effect of marital status on the outcome of patients undergoing elective or urgent coronary revascularization.

PubMed

Barbash, Israel M; Gaglia, Michael A; Torguson, Rebecca; Minha, Sa'ar; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

2013-10-01

Marriage confers various health advantages in the general population. However, the added value of marriage among patients who undergo percutaneous coronary intervention (PCI) beyond the standard cardiovascular risk factors is not clear. This study aimed to assess the effects of marital status on outcomes of patients undergoing elective or urgent PCI. Clinical observational analysis of consecutive patients undergoing elective or urgent PCI from 1993 to 2011 was performed. Patients were stratified by marital status, comparing married to unmarried patients. Clinical outcome up to 12 months was obtained by telephone contact or office visit. A total of 11,216 patients were included in the present analysis; 55% were married and 45% unmarried. Significant differences in baseline characteristics were noted, including a lower prevalence of hypertension (86% vs 88%), diabetes (34% vs 38%), and smoking (19% vs 25%) among married vs unmarried patients, respectively (P < .001). However, married patients had a higher prevalence of hypercholesterolemia and family history of coronary artery disease. Early and late major adverse cardiac event rates were significantly lower for married vs unmarried patients up to 1 year (13.3% vs 8.2%, P < .001). Married status was independently associated with improved outcome in multivariable analysis (hazard ratio 0.7, 95% CI 0.6-0.9). Married patients who undergo urgent or elective PCI have superior short- and long-term outcomes up to 1 year when compared with unmarried patients. These benefits persist after adjustment for multiple traditional cardiovascular risk factors. © 2013.

Colorectal cancer screening practices of primary care providers: results of a national survey in Malaysia.

PubMed

Norwati, Daud; Harmy, Mohamed Yusoff; Norhayati, Mohd Noor; Amry, Abdul Rahim

2014-01-01

The incidence of colorectal cancer has been increasing in many Asian countries including Malaysia during the past few decades. A physician recommendation has been shown to be a major factor that motivates patients to undergo screening. The present study objectives were to describe the practice of colorectal cancer screening by primary care providers in Malaysia and to determine the barriers for not following recommendations. In this cross sectional study involving 132 primary care providers from 44 Primary Care clinics in West Malaysia, self-administered questionnaires which consisted of demographic data, qualification, background on the primary care clinic, practices on colorectal cancer screening and barriers to colorectal cancer screening were distributed. A total of 116 primary care providers responded making a response rate of 87.9%. About 21% recommended faecal occult blood test (FOBT) in more than 50% of their patients who were eligible. The most common barrier was "unavailability of the test". The two most common patient factors are "patient in a hurry" and "poor patient awareness". This study indicates that colorectal cancer preventive activities among primary care providers are still poor in Malaysia. This may be related to the low availability of the test in the primary care setting and poor awareness and understanding of the importance of colorectal cancer screening among patients. More awareness programmes are required for the public. In addition, primary care providers should be kept abreast with the latest recommendations and policy makers need to improve colorectal cancer screening services in health clinics.

Accuracy of the volume-viscosity swallow test for clinical screening of oropharyngeal dysphagia and aspiration.

PubMed

Clavé, Pere; Arreola, Viridiana; Romea, Maise; Medina, Lucía; Palomera, Elisabet; Serra-Prat, Mateu

2008-12-01

To determine the accuracy of the bedside volume-viscosity swallow test (V-VST) for clinical screening of impaired safety and efficacy of deglutition. We studied 85 patients with dysphagia and 12 healthy subjects. Series of 5-20 mL nectar (295.02 mPa.s), liquid (21.61 mPa.s) and pudding (3682.21 mPa.s) bolus were administered during the V-VST and videofluoroscopy. Cough, fall in oxygen saturation > or =3%, and voice changes were considered signs of impaired safety, and piecemeal deglutition and oropharyngeal residue, signs of impaired efficacy. Videofluoroscopy showed patients had prolonged swallow response (> or =1064 ms); 52.1% had safe swallow at nectar, 32.9%, at liquid (p<0.05), and 80.6% at pudding viscosity (p<0.05); 29.4% had aspirations, and 45.8% oropharyngeal residue. The V-VST showed 83.7% sensitivity and 64.7% specificity for bolus penetration into the larynx and 100% sensitivity and 28.8% specificity for aspiration. Sensitivity of V-VST was 69.2% for residue, 88.4% for piecemeal deglutition, and 84.6% for identifying patients whose deglutition improved by enhancing bolus viscosity. Specificity was 80.6%, 87.5%, and 73.7%, respectively. The V-VST is a sensitive clinical method to identify patients with dysphagia at risk for respiratory and nutritional complications, and patients whose deglutition could be improved by enhancing bolus viscosity. Patients with a positive test should undergo videofluoroscopy.

Use of imaging during symptomatic follow-up after resection of pancreatic ductal adenocarcinoma.

PubMed

Groot, Vincent P; Daamen, Lois A; Hagendoorn, Jeroen; Borel Rinkes, Inne H M; van Santvoort, Hjalmar C; Molenaar, I Quintus

2018-01-01

Controversy exists whether follow-up after resection of pancreatic ductal adenocarcinoma (PDAC) should include standardized imaging for the detection of disease recurrence. The purpose of this study was to evaluate how often patients undergo imaging in a setting where routine imaging is not performed. Secondly, the pattern, timing, and treatment of recurrent PDAC were assessed. This was a post hoc analysis of a prospective database of all consecutive patients undergoing pancreatic resection of PDAC between January 2011 and January 2015. Data on imaging procedures during follow-up, recurrence location, and treatment for recurrence were extracted and analyzed. Associations between clinical characteristics and post-recurrence survival were assessed with the log-rank test and Cox univariable and multivariable proportional hazards models. A total of 85 patients were included. Seventy-four patients (87%) underwent imaging procedures during follow-up at least once, with a mean amount of 3.1 ± 1.9 imaging procedures during the entire follow-up period. Sixty-eight patients (80%) were diagnosed with recurrence, 58 (85%) of whom after the manifestation of clinical symptoms. Additional tumor-specific treatment was administered in 17 of 68 patients (25%) with recurrence. Patients with isolated local recurrence, treatment after recurrence, and a recurrence-free survival >10 mo had longer post-recurrence survival. Even though a symptomatic follow-up strategy does not include routine imaging, the majority of patients with resected PDAC underwent additional imaging procedures during their follow-up period. Further prospective studies are needed to determine the actual clinical value, psychosocial implications, and cost-effectiveness of different forms of follow-up after resection of PDAC. Copyright © 2017 Elsevier Inc. All rights reserved.

Cardiac magnetic resonance and the need for routine cardiac catheterization in single ventricle patients prior to Fontan: a comparison of 3 groups: pre-Fontan CMR versus cath evaluation.

PubMed

Fogel, Mark A; Pawlowski, Thomas W; Whitehead, Kevin K; Harris, Matthew A; Keller, Marc S; Glatz, Andrew C; Zhu, Winnie; Shore, David; Diaz, Laura K; Rome, Jonathan J

2012-09-18

This study investigated whether cardiac magnetic resonance (CMR) and echocardiography (echo) can replace catheterization (cath) for routine evaluation prior to Fontan and under what circumstances CMR and cath are used together. Routine cath prior to Fontan has been utilized for years; noninvasive methods, however, may be sufficient. This study reviews clinical data in 119 consecutive patients investigating 3 groups: those who underwent CMR alone (MR; n = 41), cath alone (C; n = 41), or both cath and CMR (C+M; n = 37) prior to Fontan. No clinically significant differences were noted in patient characteristics, hemodynamics, or clinical status prior to or after surgery between the C and MR groups. CMR added information in 82%. There were no discrepant findings between CMR and cath data in the C+M group. Diagnostic success was ≥95% in all groups. Of those undergoing Fontan completion, the C+M group had similar outcomes to C and MR; C and CMR were utilized in combination to assess aortopulmonary collaterals or the need for an intervention or evaluate its success. Echo could not delineate pulmonary arterial anatomy in 46% to 53% of patients. The C+M and C groups were exposed to 6.8 ± 4.1 mSv of radiation. Single ventricle patients not requiring an intervention can undergo successful Fontan completion with CMR and echo alone with similar short-term outcomes to C, which was used as a control, preventing an invasive test and exposure to radiation. CMR can add information in a significant number of patients. Cath and CMR are utilized together for interventions and assessment of aortopulmonary collaterals. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC) A Multicenter Placebo-Controlled Randomized Trial: Age Analysis

PubMed Central

Portman, Michael A.; Slee, April; Olson, Aaron K.; Cohen, Gordon; Karl, Tom; Tong, Elizabeth; Hastings, Laura; Patel, Hitendra; Reinhartz, Olaf; Mott, Antonio R.; Mainwaring, Richard; Linam, Justin; Danzi, Sara

2011-01-01

Background Triiodothyronine levels decrease in infants and children after cardiopulmonary bypass. We tested the primary hypothesis that triiodothyronine (T3) repletion is safe in this population and produces improvements in postoperative clinical outcome. Methods and Results The TRICC study was a prospective, multicenter, double-blind, randomized, placebo-controlled trial in children younger than 2 years old undergoing heart surgery with cardiopulmonary bypass. Enrollment was stratified by surgical diagnosis. Time to extubation (TTE) was the primary outcome. Patients received intravenous T3 as Triostat (n=98) or placebo (n=95), and data were analyzed using Cox proportional hazards. Overall, TTE was similar between groups. There were no differences in adverse event rates, including arrhythmia. Prespecified analyses showed a significant interaction between age and treatment (P=0.0012). For patients younger than 5 months, the hazard ratio (chance of extubation) for Triostat was 1.72. (P=0.0216). Placebo median TTE was 98 hours with 95% confidence interval (CI) of 71 to 142 compared to Triostat TTE at 55 hours with CI of 44 to 92. TTE shortening corresponded to a reduction in inotropic agent use and improvement in cardiac function. For children 5 months of age, or older, Triostat produced a significant delay in median TTE: 16 hours (CI, 7–22) for placebo and 20 hours (CI, 16–45) for Triostat and (hazard ratio, 0.60; P=0.0220). Conclusions T3 supplementation is safe. Analyses using age stratification indicate that T3 supplementation provides clinical advantages in patients younger than 5 months and no benefit for those older than 5 months. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00027417. PMID:20837917

Safety evaluation of a leadless transcatheter pacemaker for magnetic resonance imaging use.

PubMed

Soejima, Kyoko; Edmonson, Jonathan; Ellingson, Michael L; Herberg, Ben; Wiklund, Craig; Zhao, Jing

2016-10-01

Increased magnetic resonance imaging (MRI) adoption and demand are driving the need for device patients to have safe access to MRI. The aim of this study was to address the interactions of MRI with the Micra transcatheter pacemaker system. A strategy was developed to evaluate potential MRI risks including device heating, unintended cardiac stimulation, force, torque, vibration, and device malfunction. Assessment of MRI-induced device heating was conducted using a phantom containing gelled saline, and Monte Carlo simulations incorporating these results were conducted to simulate numerous combinations of human body models, position locations in the MRI scanner bore, and a variety of coil designs. Lastly, a patient with a Micra pacemaker who underwent a clinically indicated MRI scan is presented. Compared to traditional MRI conditional pacemakers, the overall risk with Micra was greatly reduced because of the small size of the device and the absence of a lead. The modeling results predicted that the nonperfused temperature rise of the device would be less than 0.4°C at 1.5 T and 0.5°C at 3 T and that the risk of device heating with multiple device implants was not increased as compared with a single device. The clinical case study revealed no MRI-related complications. The MRI safety assessment tests conducted for the Micra pacemaker demonstrate that patients with a single device or multiple devices can safely undergo MRI scans in both 1.5- and 3-T MRI scanners. No MRI-related complications were observed in a patient implanted with a Micra pacemaker undergoing a clinically indicated scan. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Protocol for a prospective interventional trial to develop a diagnostic index test for stroke as a cause of vertigo, dizziness and imbalance in the emergency room (EMVERT study).

PubMed

Möhwald, Ken; Bardins, Stanislavs; Müller, Hans-Helge; Jahn, Klaus; Zwergal, Andreas

2017-10-10

Identifying stroke as a cause of acute vertigo, dizziness and imbalance in the emergency room is still a clinical challenge. Many patients are admitted to stroke units, but only a minority will have strokes. This imposes a heavy financial burden on the healthcare system. The aim of this study is to develop a diagnostic index test to identify patients with a high risk of having a stroke as the cause of acute vertigo and imbalance. Patients with acute onset of vertigo, dizziness, postural imbalance or double vision within the last 24 hours lasting for at least 10 min are eligible to be included in the study. Patients with clinically proven peripheral or central aetiology will be excluded. In the emergency room, all enrolled patients will undergo standardised neuro-ophthalmological/physiological testing (including video-oculography, mobile posturography, measurement of subjective visual vertical) (EMVERT block 1). Within 10 days, standardised MRI will be performed as a reference test to identify stroke (EMVERT block 2). Data from EMVERT block 2 will be compared with results from block 1 in order to devise a diagnostic index test with a high specificity and sensitivity to predict the risk of stroke in the emergency room. The study was approved by the ethics committee of the University of Munich and will be conducted according to the Guideline for Good Clinical Practice, the Federal Data Protecting Act and the Helsinki Declaration of the World Medical Association in its recent version. Study results are expected to be published in international peer-reviewed journals and will be presented at international conferences. German Clinical Trial Register: DRKS00008992; Universal trial number: U1111-1172-8719); pre-results. © 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.

Protocol for a prospective interventional trial to develop a diagnostic index test for stroke as a cause of vertigo, dizziness and imbalance in the emergency room (EMVERT study)

PubMed Central

Bardins, Stanislavs; Müller, Hans-Helge; Jahn, Klaus; Zwergal, Andreas

2017-01-01

Introduction Identifying stroke as a cause of acute vertigo, dizziness and imbalance in the emergency room is still a clinical challenge. Many patients are admitted to stroke units, but only a minority will have strokes. This imposes a heavy financial burden on the healthcare system. The aim of this study is to develop a diagnostic index test to identify patients with a high risk of having a stroke as the cause of acute vertigo and imbalance. Methods and analysis Patients with acute onset of vertigo, dizziness, postural imbalance or double vision within the last 24 hours lasting for at least 10 min are eligible to be included in the study. Patients with clinically proven peripheral or central aetiology will be excluded. In the emergency room, all enrolled patients will undergo standardised neuro-ophthalmological/physiological testing (including video-oculography, mobile posturography, measurement of subjective visual vertical) (EMVERT block 1). Within 10 days, standardised MRI will be performed as a reference test to identify stroke (EMVERT block 2). Data from EMVERT block 2 will be compared with results from block 1 in order to devise a diagnostic index test with a high specificity and sensitivity to predict the risk of stroke in the emergency room. Ethics and dissemination The study was approved by the ethics committee of the University of Munich and will be conducted according to the Guideline for Good Clinical Practice, the Federal Data Protecting Act and the Helsinki Declaration of the World Medical Association in its recent version. Study results are expected to be published in international peer-reviewed journals and will be presented at international conferences. Trial registration number German Clinical Trial Register: DRKS00008992; Universal trial number: U1111-1172-8719); pre-results. PMID:29018076

Development of the Canadian Physiotherapy Assessment of Clinical Performance: A New Tool to Assess Physiotherapy Students' Performance in Clinical Education.

PubMed

Mori, Brenda; Brooks, Dina; Norman, Kathleen E; Herold, Jodi; Beaton, Dorcas E

2015-08-01

To develop the first draft of a Canadian tool to assess physiotherapy (PT) students' performance in clinical education (CE). Phase 1: to gain consensus on the items within the new tool, the number and placement of the comment boxes, and the rating scale; Phase 2: to explore the face and content validity of the draft tool. Phase 1 used the Delphi method; Phase 2 used cognitive interviewing methods with recent graduates and clinical instructors (CIs) and detailed interviews with clinical education and measurement experts. Consensus was reached on the first draft of the new tool by round 3 of the Delphi process, which was completed by 21 participants. Interviews were completed with 13 CIs, 6 recent graduates, and 7 experts. Recent graduates and CIs were able to interpret the tool accurately, felt they could apply it to a recent CE experience, and provided suggestions to improve the draft. Experts provided salient advice. The first draft of a new tool to assess PT students in CE, the Canadian Physiotherapy Assessment of Clinical Performance (ACP), was developed and will undergo further development and testing, including national consultation with stakeholders. Data from Phase 2 will contribute to developing an online education module for CIs and students.

The Society for Translational Medicine: clinical practice guidelines for mechanical ventilation management for patients undergoing lobectomy.

PubMed

Gao, Shugeng; Zhang, Zhongheng; Brunelli, Alessandro; Chen, Chang; Chen, Chun; Chen, Gang; Chen, Haiquan; Chen, Jin-Shing; Cassivi, Stephen; Chai, Ying; Downs, John B; Fang, Wentao; Fu, Xiangning; Garutti, Martínez I; He, Jianxing; He, Jie; Hu, Jian; Huang, Yunchao; Jiang, Gening; Jiang, Hongjing; Jiang, Zhongmin; Li, Danqing; Li, Gaofeng; Li, Hui; Li, Qiang; Li, Xiaofei; Li, Yin; Li, Zhijun; Liu, Chia-Chuan; Liu, Deruo; Liu, Lunxu; Liu, Yongyi; Ma, Haitao; Mao, Weimin; Mao, Yousheng; Mou, Juwei; Ng, Calvin Sze Hang; Petersen, René H; Qiao, Guibin; Rocco, Gaetano; Ruffini, Erico; Tan, Lijie; Tan, Qunyou; Tong, Tang; Wang, Haidong; Wang, Qun; Wang, Ruwen; Wang, Shumin; Xie, Deyao; Xue, Qi; Xue, Tao; Xu, Lin; Xu, Shidong; Xu, Songtao; Yan, Tiansheng; Yu, Fenglei; Yu, Zhentao; Zhang, Chunfang; Zhang, Lanjun; Zhang, Tao; Zhang, Xun; Zhao, Xiaojing; Zhao, Xuewei; Zhi, Xiuyi; Zhou, Qinghua

2017-09-01

Patients undergoing lobectomy are at significantly increased risk of lung injury. One-lung ventilation is the most commonly used technique to maintain ventilation and oxygenation during the operation. It is a challenge to choose an appropriate mechanical ventilation strategy to minimize the lung injury and other adverse clinical outcomes. In order to understand the available evidence, a systematic review was conducted including the following topics: (I) protective ventilation (PV); (II) mode of mechanical ventilation [e.g., volume controlled (VCV) versus pressure controlled (PCV)]; (III) use of therapeutic hypercapnia; (IV) use of alveolar recruitment (open-lung) strategy; (V) pre-and post-operative application of positive end expiratory pressure (PEEP); (VI) Inspired Oxygen concentration; (VII) Non-intubated thoracoscopic lobectomy; and (VIII) adjuvant pharmacologic options. The recommendations of class II are non-intubated thoracoscopic lobectomy may be an alternative to conventional one-lung ventilation in selected patients. The recommendations of class IIa are: (I) Therapeutic hypercapnia to maintain a partial pressure of carbon dioxide at 50-70 mmHg is reasonable for patients undergoing pulmonary lobectomy with one-lung ventilation; (II) PV with a tidal volume of 6 mL/kg and PEEP of 5 cmH 2 O are reasonable methods, based on current evidence; (III) alveolar recruitment [open lung ventilation (OLV)] may be beneficial in patients undergoing lobectomy with one-lung ventilation; (IV) PCV is recommended over VCV for patients undergoing lung resection; (V) pre- and post-operative CPAP can improve short-term oxygenation in patients undergoing lobectomy with one-lung ventilation; (VI) controlled mechanical ventilation with I:E ratio of 1:1 is reasonable in patients undergoing one-lung ventilation; (VII) use of lowest inspired oxygen concentration to maintain satisfactory arterial oxygen saturation is reasonable based on physiologic principles; (VIII) Adjuvant drugs such as nebulized budesonide, intravenous sivelestat and ulinastatin are reasonable and can be used to attenuate inflammatory response.

The Society for Translational Medicine: clinical practice guidelines for mechanical ventilation management for patients undergoing lobectomy

PubMed Central

Zhang, Zhongheng; Brunelli, Alessandro; Chen, Chang; Chen, Chun; Chen, Gang; Chen, Haiquan; Chen, Jin-Shing; Cassivi, Stephen; Chai, Ying; Downs, John B.; Fang, Wentao; Fu, Xiangning; Garutti, Martínez I.; He, Jianxing; Hu, Jian; Huang, Yunchao; Jiang, Gening; Jiang, Hongjing; Jiang, Zhongmin; Li, Danqing; Li, Gaofeng; Li, Hui; Li, Qiang; Li, Xiaofei; Li, Yin; Li, Zhijun; Liu, Chia-Chuan; Liu, Deruo; Liu, Lunxu; Liu, Yongyi; Ma, Haitao; Mao, Weimin; Mao, Yousheng; Mou, Juwei; Ng, Calvin Sze Hang; Petersen, René H.; Qiao, Guibin; Rocco, Gaetano; Ruffini, Erico; Tan, Lijie; Tan, Qunyou; Tong, Tang; Wang, Haidong; Wang, Qun; Wang, Ruwen; Wang, Shumin; Xie, Deyao; Xue, Qi; Xue, Tao; Xu, Lin; Xu, Shidong; Xu, Songtao; Yan, Tiansheng; Yu, Fenglei; Yu, Zhentao; Zhang, Chunfang; Zhang, Lanjun; Zhang, Tao; Zhang, Xun; Zhao, Xiaojing; Zhao, Xuewei; Zhi, Xiuyi; Zhou, Qinghua

2017-01-01

Patients undergoing lobectomy are at significantly increased risk of lung injury. One-lung ventilation is the most commonly used technique to maintain ventilation and oxygenation during the operation. It is a challenge to choose an appropriate mechanical ventilation strategy to minimize the lung injury and other adverse clinical outcomes. In order to understand the available evidence, a systematic review was conducted including the following topics: (I) protective ventilation (PV); (II) mode of mechanical ventilation [e.g., volume controlled (VCV) versus pressure controlled (PCV)]; (III) use of therapeutic hypercapnia; (IV) use of alveolar recruitment (open-lung) strategy; (V) pre-and post-operative application of positive end expiratory pressure (PEEP); (VI) Inspired Oxygen concentration; (VII) Non-intubated thoracoscopic lobectomy; and (VIII) adjuvant pharmacologic options. The recommendations of class II are non-intubated thoracoscopic lobectomy may be an alternative to conventional one-lung ventilation in selected patients. The recommendations of class IIa are: (I) Therapeutic hypercapnia to maintain a partial pressure of carbon dioxide at 50–70 mmHg is reasonable for patients undergoing pulmonary lobectomy with one-lung ventilation; (II) PV with a tidal volume of 6 mL/kg and PEEP of 5 cmH2O are reasonable methods, based on current evidence; (III) alveolar recruitment [open lung ventilation (OLV)] may be beneficial in patients undergoing lobectomy with one-lung ventilation; (IV) PCV is recommended over VCV for patients undergoing lung resection; (V) pre- and post-operative CPAP can improve short-term oxygenation in patients undergoing lobectomy with one-lung ventilation; (VI) controlled mechanical ventilation with I:E ratio of 1:1 is reasonable in patients undergoing one-lung ventilation; (VII) use of lowest inspired oxygen concentration to maintain satisfactory arterial oxygen saturation is reasonable based on physiologic principles; (VIII) Adjuvant drugs such as nebulized budesonide, intravenous sivelestat and ulinastatin are reasonable and can be used to attenuate inflammatory response. PMID:29221302

The Dark Side of the Moon: Meta-analytical Impact of Recruitment Strategies on Risk Enrichment in the Clinical High Risk State for Psychosis

PubMed Central

Fusar-Poli, Paolo; Schultze-Lutter, Frauke; Cappucciati, Marco; Rutigliano, Grazia; Bonoldi, Ilaria; Stahl, Daniel; Borgwardt, Stephan; Riecher-Rössler, Anita; Addington, Jean; Perkins, Diana O.; Woods, Scott W.; McGlashan, Thomas; Lee, Jimmy; Klosterkötter, Joachim; Yung, Alison R.; McGuire, Philip

2016-01-01

Background: The individual risk of developing psychosis after being tested for clinical high-risk (CHR) criteria (posttest risk of psychosis) depends on the underlying risk of the disease of the population from which the person is selected (pretest risk of psychosis), and thus on recruitment strategies. Yet, the impact of recruitment strategies on pretest risk of psychosis is unknown. Methods: Meta-analysis of the pretest risk of psychosis in help-seeking patients selected to undergo CHR assessment: total transitions to psychosis over the pool of patients assessed for potential risk and deemed at risk (CHR+) or not at risk (CHR−). Recruitment strategies (number of outreach activities per study, main target of outreach campaign, and proportion of self-referrals) were the moderators examined in meta-regressions. Results: 11 independent studies met the inclusion criteria, for a total of 2519 (CHR+: n = 1359; CHR−: n = 1160) help-seeking patients undergoing CHR assessment (mean follow-up: 38 months). The overall meta-analytical pretest risk for psychosis in help-seeking patients was 15%, with high heterogeneity (95% CI: 9%–24%, I 2 = 96, P < .001). Recruitment strategies were heterogeneous and opportunistic. Heterogeneity was largely explained by intensive (n = 11, β = −.166, Q = 9.441, P = .002) outreach campaigns primarily targeting the general public (n = 11, β = −1.15, Q = 21.35, P < .001) along with higher proportions of self-referrals (n = 10, β = −.029, Q = 4.262, P = .039), which diluted pretest risk for psychosis in patients undergoing CHR assessment. Conclusions: There is meta-analytical evidence for overall risk enrichment (pretest risk for psychosis at 38monhts = 15%) in help-seeking samples selected for CHR assessment as compared to the general population (pretest risk of psychosis at 38monhts=0.1%). Intensive outreach campaigns predominantly targeting the general population and a higher proportion of self-referrals diluted the pretest risk for psychosis. PMID:26591006

Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study.

PubMed

Becker, Richard C; Moliterno, David J; Jennings, Lisa K; Pieper, Karen S; Pei, Jinglan; Niederman, Alan; Ziada, Khaled M; Berman, Gail; Strony, John; Joseph, Diane; Mahaffey, Kenneth W; Van de Werf, Frans; Veltri, Enrico; Harrington, Robert A

2009-03-14

An antithrombotic drug is needed that safely reduces cardiovascular events in patients undergoing percutaneous coronary intervention (PCI). We therefore assessed the tolerability and safety of SCH 530348-an oral platelet protease-activated receptor-1 antagonist. We randomly assigned patients aged 45 years or older and undergoing non-urgent PCI or coronary angiography with planned PCI to an oral loading dose of SCH 530348 (10 mg, 20 mg, or 40 mg) or matching placebo in a 3:1 ratio in a multicentre international study. Those in the SCH 530348 group who subsequently underwent PCI (primary PCI cohort) continued taking an oral maintenance dose (0.5 mg, 1.0 mg, or 2.5 mg per day), and patients in the placebo group continued placebo for 60 days. The primary endpoint was the incidence of clinically significant major or minor bleeding according to the thrombolysis in myocardial infarction (TIMI) scale. Both investigators and patients were unaware of treatment allocation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00132912. 257 patients were assigned to placebo and 773 to SCH 530348. The primary endpoint occurred in 2 (2%) of 129, 3 (3%) of 120, and 7 (4%) of 173 patients, respectively, in the SCH 530348 10 mg, 20 mg, and 40 mg groups compared with 5 (3%) of 151 patients in the placebo group (p=0.5786). TIMI major plus minor bleeding occurred in 3 (2%) of 136, 5 (4%) of 139, and 4 (3%) of 138 patients given SCH 530348 0.5 mg, 1.0 mg, and 2.5 mg once per day, respectively (p=0.7561). Oral SCH 530348 was generally well tolerated and did not cause increased TIMI bleeding, even when administered concomitantly with aspirin and clopidogrel. Further testing in phase III trials to accurately define the safety and efficacy of SCH 530348 is warranted.

Primary and Secondary Prevention of Cardiovascular Disease

PubMed Central

Vandvik, Per Olav; Lincoff, A. Michael; Gore, Joel M.; Gutterman, David D.; Sonnenberg, Frank A.; Alonso-Coello, Pablo; Akl, Elie A.; Lansberg, Maarten G.; Guyatt, Gordon H.

2012-01-01

Background: This guideline focuses on long-term administration of antithrombotic drugs designed for primary and secondary prevention of cardiovascular disease, including two new antiplatelet therapies. Methods: The methods of this guideline follow those described in Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines in this supplement. Results: We present 23 recommendations for pertinent clinical questions. For primary prevention of cardiovascular disease, we suggest low-dose aspirin (75-100 mg/d) in patients aged > 50 years over no aspirin therapy (Grade 2B). For patients with established coronary artery disease, defined as patients 1-year post-acute coronary syndrome, with prior revascularization, coronary stenoses > 50% by coronary angiogram, and/or evidence for cardiac ischemia on diagnostic testing, we recommend long-term low-dose aspirin or clopidogrel (75 mg/d) (Grade 1A). For patients with acute coronary syndromes who undergo percutaneous coronary intervention (PCI) with stent placement, we recommend for the first year dual antiplatelet therapy with low-dose aspirin in combination with ticagrelor 90 mg bid, clopidogrel 75 mg/d, or prasugrel 10 mg/d over single antiplatelet therapy (Grade 1B). For patients undergoing elective PCI with stent placement, we recommend aspirin (75-325 mg/d) and clopidogrel for a minimum duration of 1 month (bare-metal stents) or 3 to 6 months (drug-eluting stents) (Grade 1A). We suggest continuing low-dose aspirin plus clopidogrel for 12 months for all stents (Grade 2C). Thereafter, we recommend single antiplatelet therapy over continuation of dual antiplatelet therapy (Grade 1B). Conclusions: Recommendations continue to favor single antiplatelet therapy for patients with established coronary artery disease. For patients with acute coronary syndromes or undergoing elective PCI with stent placement, dual antiplatelet therapy for up to 1 year is warranted. PMID:22315274

Objective visual assessment of antiangiogenic treatment for wet age-related macular degeneration.

PubMed

Baseler, Heidi A; Gouws, André; Crossland, Michael D; Leung, Carmen; Tufail, Adnan; Rubin, Gary S; Morland, Antony B

2011-10-01

To assess cortical responses in patients undergoing antiangiogenic treatment for wet age-related macular degeneration (AMD) using functional magnetic resonance imaging (fMRI) as an objective, fixation-independent measure of topographic visual function. A patient with bilateral neovascular AMD was scanned using fMRI before and at regular intervals while undergoing treatment with intravitreal antiangiogenic injections (ranibizumab). Blood oxygenation level-dependent signals were measured in the brain while the patient viewed a stimulus consisting of a full-field flickering (6 Hz) white light alternating with a uniform gray background (18 s on and 18 s off). Topographic distribution and magnitude of activation in visual cortex were compared longitudinally throughout the treatment period (<1 year) and with control patients not currently undergoing treatment. Clinical behavioral tests were also administered, including visual acuity, microperimetry, and reading skills. The area of visual cortex activated increased significantly after the first treatment to include more posterior cortex that normally receives inputs from lesioned parts of the retina. Subsequent treatments yielded no significant further increase in activation area. Behavioral measures all generally showed an improvement with treatment but did not always parallel one another. The untreated control patient showed a consistent lack of significant response in the cortex representing retinal lesions. Retinal treatments may not only improve vision but also result in a concomitant improvement in fixation stability. Current clinical behavioral measures (e.g., acuity and perimetry) are largely dependent on fixation stability and therefore cannot separate improvements of visual function from fixation improvements. fMRI, which provides an objective and sensitive measure of visual function independent of fixation, reveals a significant increase in visual cortical responses in patients with wet AMD after treatment with antiangiogenic injections. Despite recent evidence that visual cortex degenerates subsequent to retinal lesions, our results indicate that it can remain responsive as its inputs are restored.

Tolerability of 2.5% Lidocaine/Prilocaine Hydrogel in Children Undergoing Cryotherapy for Molluscum Contagiosum.

PubMed

Gobbato, André A M; Babadópulos, Tainah; Gobbato, Cintia A R S; Moreno, Ronilson A; Gagliano-Jucá, Thiago; De Nucci, Gilberto

2016-05-01

The tolerability of a 2.5% lidocaine/prilocaine hydrogel (Nanorap, Biolab Indústria Farmacêutica Ltd., Sao Paulo, Brazil) was evaluated in 20 children ages 2 to 11 years undergoing cryotherapy for molluscum contagiosum (MC). The product was well tolerated, with only two children presenting with eczema at the application site. These adverse reactions were considered unlikely to be related to the test product, because a patch test was negative in one of the individuals and the other event occurred in only one of the two treated areas. Nanorap is an efficacious and well-tolerated option for topical anesthesia in children undergoing cryotherapy for MC. © 2016 Wiley Periodicals, Inc.

Usability Testing of an Interactive Virtual Reality Distraction Intervention to Reduce Procedural Pain in Children and Adolescents With Cancer.

PubMed

Birnie, Kathryn A; Kulandaivelu, Yalinie; Jibb, Lindsay; Hroch, Petra; Positano, Karyn; Robertson, Simon; Campbell, Fiona; Abla, Oussama; Stinson, Jennifer

2018-06-01

Needle procedures are among the most distressing aspects of pediatric cancer-related treatment. Virtual reality (VR) distraction offers promise for needle-related pain and distress given its highly immersive and interactive virtual environment. This study assessed the usability (ease of use and understanding, acceptability) of a custom VR intervention for children with cancer undergoing implantable venous access device (IVAD) needle insertion. Three iterative cycles of mixed-method usability testing with semistructured interviews were undertaken to refine the VR. Participants included 17 children and adolescents (8-18 years old) with cancer who used the VR intervention prior to or during IVAD access. Most participants reported the VR as easy to use (82%) and understand (94%), and would like to use it during subsequent needle procedures (94%). Based on usability testing, refinements were made to VR hardware, software, and clinical implementation. Refinements focused on increasing responsiveness, interaction, and immersion of the VR program, reducing head movement for VR interaction, and enabling participant alerts to steps of the procedure by clinical staff. No adverse events of nausea or dizziness were reported. The VR intervention was deemed acceptable and safe. Next steps include assessing feasibility and effectiveness of the VR intervention for pain and distress.

Regulatory considerations on new adjuvants and delivery systems.

PubMed

Sesardic, D

2006-04-12

New and improved vaccines and delivery systems are increasingly being developed for prevention, treatment and diagnosis of human diseases. Prior to their use in humans, all new biological products must undergo pre-clinical evaluation. These pre-clinical studies are important not only to establish the biological properties of the material and to evaluate its possible risk to the public, but also to plan protocols for subsequent clinical trials from which safety and efficacy can be evaluated. For vaccines, evaluation in pre-clinical studies is particularly important as information gained may also contribute to identifying the optimum composition and formulation process and provide an opportunity to develop suitable indicator tests for quality control. Data from pre-clinical and laboratory evaluation studies, which continue during clinical studies, is used to support an application for marketing authorisation. Addition of a new adjuvant and exploration of new delivery systems for vaccines presents challenges to both manufacturers and regulatory authorities. Because no adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine, pre-clinical and appropriate toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/vaccine combination. Current regulatory requirements for the pharmaceutical and pre-clinical safety assessment of vaccines are insufficient and initiatives are in place to develop more specific guidelines for evaluation of adjuvants in vaccines.

A Prospective Blinded Evaluation of Urine-DNA Testing for Detection of Urothelial Bladder Carcinoma in Patients with Gross Hematuria.

PubMed

Dahmcke, Christina M; Steven, Kenneth E; Larsen, Louise K; Poulsen, Asger L; Abdul-Al, Ahmad; Dahl, Christina; Guldberg, Per

2016-12-01

Retrospective studies have provided proof of principle that bladder cancer can be detected by testing for the presence of tumor DNA in urine. We have conducted a prospective blinded study to determine whether a urine-based DNA test can replace flexible cystoscopy in the initial assessment of gross hematuria. A total of 475 consecutive patients underwent standard urological examination including flexible cystoscopy and computed tomography urography, and provided urine samples immediately before (n=461) and after (n=444) cystoscopy. Urine cells were collected using a filtration device and tested for eight DNA mutation and methylation biomarkers. Clinical evaluation identified 99 (20.8%) patients with urothelial bladder tumors. With this result as a reference and based on the analysis of all urine samples, the DNA test had a sensitivity of 97.0%, a specificity of 76.9%, a positive predictive value of 52.5%, and a negative predictive value of 99.0%. In three patients with a positive urine-DNA test without clinical evidence of cancer, a tumor was detected at repeat cystoscopy within 16 mo. Our results suggest that urine-DNA testing can be used to identify a large subgroup of patients with gross hematuria in whom cystoscopy is not required. We tested the possibility of using a urine-based DNA test to check for bladder cancer in patients with visible blood in the urine. Our results show that the test efficiently detects bladder cancer and therefore may be used to greatly reduce the number of patients who would need to undergo cystoscopy. Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

The Asia-Pacific Evaluation of Cardiovascular Therapies (ASPECT) collaboration --improving the quality of cardiovascular care in the Asia Pacific region.

PubMed

Reid, Christopher M; Yan, Bryan; Wan Ahmad, Wan Azman; Bang, Liew Houng; Hian, Sim Kui; Chua, Terrance; Chan, Mark; Beltrame, John; Duffy, Stephen J; Brennan, Angela; Ajani, Andrew

2014-03-01

Clinicians and other stakeholders recognize the need for clinical registries to monitor data in order to improve the outcome and quality of care in the delivery of medical interventions. The establishment of a collaboration across the Asia Pacific Region to inform on variations in patient and procedural characteristics and associated clinical outcomes would enable regional benchmarking of quality. The aims of the collaboration are a) to identify the characteristics of patients undergoing PCI across the Asia Pacific region, b) to report on outcomes of patients undergoing PCI, c) to develop an appropriate ethnic and region specific risk adjustment model for patients undergoing PCI and d) to establish a registry framework for research, education and training in the area of cardiovascular interventions across the Asia Pacific Region. Descriptive characteristics of patient undergoing PCI over a 12 month period were collated and reported. Representatives from 27 hospitals attended the inaugural meeting with interested parties from Australia, Singapore, Malaysia and Hong Kong. In every country, males predominated PCI activity. Subjects were older and had higher rates of family history of cardiovascular disease in Australia, while Asian subjects had higher rates of diabetes, dyslipidemia and renal failure. STEMI presentation was higher in Australia than in Asia and drug eluting stent use was higher in Asia. Procedural success rates were similar across the region (>95%). Procedural success was similar across the region despite differing patient characteristics across countries in terms of pre-procedural risk factors and clinical presentation. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

BRCA1 and BRCA2 mutations in women of different ethnicities undergoing testing for hereditary breast-ovarian cancer

PubMed Central

Hall, Michael J.; Reid, Julia E.; Burbidge, Lynn A.; Pruss, Dmitry; Deffenbaugh, Amie M.; Frye, Cynthia; Wenstrup, Richard J.; Ward, Brian E.; Scholl, Thomas A.; Noll, Walter W.

2009-01-01

Background In women at increased risk for breast and ovarian cancer, the identification of a BRCA1/2 mutation has important implications for screening and prevention counseling. Uncertainty regarding the role of BRCA1/2 testing in high-risk women from diverse ancestral backgrounds exists due to variability in prevalence estimates of deleterious (disease-associated) mutations in non-White populations. We examined the prevalence of BRCA1/2 mutations in an ethnically diverse group of women referred for genetic testing. Methods We conducted a cross-sectional analysis to assess the prevalence of BRCA1/2 mutations in a group of non-Ashkenazi Jewish women undergoing genetic testing. Results From 1996-2006, 46,276 women meeting study criteria underwent DNA full-sequence analysis of the BRCA1 and BRCA2 genes. Deleterious mutations were identified in 12.5% of subjects, and recurrent deleterious mutations (prevalence > 2%) were identified in all ancestral groups. Women of non-European descent were younger (45.9 yrs, SD11.6) than European (50.0 yrs, SD11.9)(p<0.001). Women of African (15.6%)[OR 1.3(1.1-1.5)] and Latin American (14.8%)[OR 1.2(1.1-1.4)] ancestries had a significantly higher prevalence of deleterious BRCA1/2 mutations compared to women of Western European ancestry (12.1%), primarily due to an increased prevalence of BRCA1 mutations in these two groups. Non-European ethnicity was strongly associated with having a variant of uncertain significance; however, re-classification decreased variant reporting (12.8%→5.9%), with women of African ancestry experiencing the largest decline (58%). Conclusions Mutation prevalence is high among women referred for clinical BRCA1/2 testing, and risk is similar across diverse ethnicities. BRCA1/2 testing is integral to cancer risk assessment in all high-risk women. PMID:19241424

Sexually transmitted infection (STI) testing among young oil and gas workers: the need for innovative, place-based approaches to STI control.

PubMed

Goldenberg, Shira M; Shoveller, Jean A; Ostry, Aleck C; Koehoorn, Mieke

2008-01-01

Northeastern British Columbia is undergoing rapid in-migration of young, primarily male workers in response to the "boom" in the oil/gas industries. Accompanying the boom is a rise in Chlamydia rates among youth, which exceed the provincial average by 22%. STI testing reduces the disease burden, contributing to STI prevention. 1) To document youths' perceptions regarding the socio-cultural and structural forces that affect young oil/gas workers' access to STI testing; 2) to gather service providers' perspectives on sexual health service delivery for workers; and 3) to develop recommendations to improve the accessibility of STI testing. We conducted ethnographic fieldwork (8 weeks) in a remote oil/gas community, including in-depth interviews with 25 young people (ages 15-25) and 14 health and social service providers. Participants identified limited opportunities to access testing, geographic isolation, and 'rigger' culture as three key categories inhibiting STI testing among oil/gas Workers. These results suggest the need for place-based approaches to STI control. Innovative outreach strategies are suggested to address oil/gas workers' needs, including a locally tailored STI awareness campaign, condom distribution, expanded clinic hours, and onsite STI testing.

Cerebrospinal fluid HIV RNA in persons living with HIV.

PubMed

Di Carlofelice, M; Everitt, A; Muir, D; Winston, A

2018-05-01

Despite adequate suppression of plasma HIV RNA, viral escape in cerebrospinal fluid (CSF) is widely reported. Rates of CSF HIV RNA escape vary in the literature. In persons living with HIV (PLWH) undergoing lumbar puncture examination for clinical reasons, we assessed rates of CSF HIV RNA escape. Persons living with HIV attending a designated HIV neurology service undergoing CSF assessment for clinical reasons between January 2015 and April 2017 were included in the study. CSF HIV RNA escape was defined as HIV RNA ≥ 0.5 log 10 HIV-1 RNA copies/mL higher than plasma HIV RNA or detectable CSF HIV RNA when plasma HIV RNA was < 20 copies/mL. Clinical factors associated with CSF HIV RNA were assessed using logistic regression modelling. Of 38 individuals, 35 were receiving antiretroviral therapy, 30 were male and their mean age was 51 years. Clinical reasons for CSF assessment included investigation for cognitive decline (n = 25), early syphilis (n = 4) and other central nervous system (CNS) conditions (n = 9). HIV RNA was detectable in plasma and CSF in seven and six individuals, respectively, with two individuals (5.3%) meeting the definition of CSF escape. Detectable CSF HIV RNA was associated with a detectable plasma HIV RNA (P < 0.001) and a history of known antiretroviral drug resistance mutations (P = 0.021). The prevalence of CSF viral escape in PLWH undergoing lumbar puncture examination for clinical reasons is lower than previously reported. © 2018 British HIV Association.

The risk of bronchospasm in asthmatics undergoing general anaesthesia and/or intravascular administration of radiographic contrast media. physiopatology and clinical/functional evaluation.

PubMed

Liccardi, G; Salzillo, A; Piccolo, A; De Napoli, I; D'Amato, G

2010-10-01

It is well known that patients suffering from bronchial asthma undergoing to surgical procedures requiring general anaesthesia (GA) or the administration of water soluble radiographic contrast media (RCM) experience a risk of potentially severe bronchospasm. Nevertheless, little attention has been devoted on the possible preventive measures to reduce the occurrence of this potentially life-threatening event. It has been shown that the most important risk factor for bronchospasm during GA induction and/or the use of RCM is represented by a high degree of bronchial hyperreactivity with airway instability not adequately controlled by long-term anti-inflammatory treatment. The aim of this review is to underline the need for an accurate clinical and functional evaluation of asthmatics (especially those with a relevant degree of asthma severity) undergoing GA or administration of RCM. Guidelines shared by pulmonologists, allergologists, anesthesiologists and radiologists should be produced in the future for a better evaluation and management of these patients. General practitioner plays an important role in managing asthmatic patients in "Real Life". It is likely that "Real Life"--optimally controlled asthmatics could undergo GA/RCM with lower risks especially in emergency conditions when it is not possible to perform any preoperative evaluation.

Oral supplementation with carbohydrate- and branched-chain amino acid-enriched nutrients improves postoperative quality of life in patients undergoing hepatic resection.

PubMed

Okabayashi, Takehiro; Iyoki, Miho; Sugimoto, Takeki; Kobayashi, Michiya; Hanazaki, Kazuhiro

2011-04-01

The long-term outcomes of branched-chain amino acid (BCAA) administration in patients undergoing hepatic resection remain unclear. The aim of this study is to assess the impact of oral supplementation with BCAA-enriched nutrients on postoperative quality of life (QOL) in patients undergoing liver resection. A prospective randomized clinical trial was conducted in 96 patients undergoing hepatic resection. Patients were randomly assigned to receive BCAA supplementation (AEN group, n = 48) or a conventional diet (control group, n = 48). Postoperative QOL and short-term outcomes were regularly and continuously evaluated in all patients using a short-form 36 (SF-36) health questionnaire and by measuring various clinical parameters. This study demonstrated a significant improvement in QOL after hepatectomy for liver neoplasm in the AEN group based on the same patients' preoperative SF-36 scores (P < 0.05). Perioperative BCAA supplementation preserved liver function and general patient health in the short term for AEN group patients compared to those not receiving the nutritional supplement. BCAA supplementation improved postoperative QOL after hepatic resection over the long term by restoring and maintaining nutritional status and whole-body kinetics. This study was registered at http://www.clinicaltrials.gov (registration number: NCT00945568).

Effectiveness of ketamine as an adjuvant to opioid-based therapy in decreasing pain associated with opioid tolerance in adults undergoing orthopedic surgery: a systematic review protocol.

PubMed

Bennett, Marsha; Bonanno, Laura; Kuhn, William

2016-10-01

The objective of this systematic review is to examine the best available evidence on the clinical effectiveness of ketamine as an adjuvant to opioid-based therapy versus opioid-based therapy alone in decreasing perioperative pain associated with opioid tolerance in adult patients, aged 18-70 years, undergoing orthopedic surgical procedures.The following question guides the systematic review: does the administration of ketamine as an adjuvant to opioid-based therapy, compared to opioid-based therapy alone, improve perioperative pain relief in opioid-tolerant adult patients undergoing orthopedic surgical procedures?

Racial/Ethnic Differences in Illness Perceptions in Minority Patients Undergoing Maintenance Hemodialysis

PubMed Central

Kim, Youngmee; Pavlish, Carol; Evangelista, Lorraine S.; Kopple, Joel D.; Phillips, Linda R.

2012-01-01

This study examined whether racial/ethnic differences in illness perceptions exist among patients on maintenance hemodialysis. One hundred sixty-one patients with end stage renal disease (ESRD) undergoing maintenance hemodialysis (20% African Americans, 44% Hispanics, 9% Filipinos, and 27% Koreans) completed the Revised Illness Perception Questionnaire. Korean participants had higher emotional disturbance than their counterparts, whereas African-American participants had higher negative perceptions of personal intervention or medical treatment controlling their disease. This study indicates that patients from different racial/ethnic backgrounds undergoing maintenance hemodialysis may perceive their disease differently. This phenomenon could affect clinical outcomes and may require different therapeutic approaches. PMID:22480051

Consensus and clinical recommendations for nutritional intervention for head and neck cancer patients undergoing chemoradiotherapy in Taiwan.

PubMed

Lin, Mei-Chun; Shueng, Pei-Wei; Chang, Wei-Kuo; Mu-Hsin Chang, Peter; Feng, Hsin-Chun; Yang, Muh-Hwa; Lou, Pei-Jen

2018-06-01

Because of the anatomical location, patients with head and neck cancer (HNC) frequently experience dysphagia and malnutrition at the time of diagnosis and these conditions are often exacerbated after chemoradiotherapy. There is an emerging medical need to establish a consensus on nutritional intervention for these patients. A panel of 30 senior physicians and experts from multidisciplinary teams drafted clinical recommendations to improve the management of nutritional interventions in Taiwan and to provide updated treatment strategy recommendations in hope of improving the nutritional status of patients with HNC. This clinical review describes the resulting consensus document, including the impact of malnutrition on clinical outcomes, the role of prophylactic tube feeding, the choice of tube feeding, and the benefit of oral nutritional supplements in patients with HNC undergoing chemoradiotherapy. The outcomes of this review will support clinicians in their efforts to improve the nutritional status of patients with HNC. Copyright © 2018 Elsevier Ltd. All rights reserved.

A suite of phantom-based test methods for assessing image quality of photoacoustic tomography systems

NASA Astrophysics Data System (ADS)

Vogt, William C.; Jia, Congxian; Wear, Keith A.; Garra, Brian S.; Pfefer, T. Joshua

2017-03-01

As Photoacoustic Tomography (PAT) matures and undergoes clinical translation, objective performance test methods are needed to facilitate device development, regulatory clearance and clinical quality assurance. For mature medical imaging modalities such as CT, MRI, and ultrasound, tissue-mimicking phantoms are frequently incorporated into consensus standards for performance testing. A well-validated set of phantom-based test methods is needed for evaluating performance characteristics of PAT systems. To this end, we have constructed phantoms using a custom tissue-mimicking material based on PVC plastisol with tunable, biologically-relevant optical and acoustic properties. Each phantom is designed to enable quantitative assessment of one or more image quality characteristics including 3D spatial resolution, spatial measurement accuracy, ultrasound/PAT co-registration, uniformity, penetration depth, geometric distortion, sensitivity, and linearity. Phantoms contained targets including high-intensity point source targets and dye-filled tubes. This suite of phantoms was used to measure the dependence of performance of a custom PAT system (equipped with four interchangeable linear array transducers of varying design) on design parameters (e.g., center frequency, bandwidth, element geometry). Phantoms also allowed comparison of image artifacts, including surface-generated clutter and bandlimited sensing artifacts. Results showed that transducer design parameters create strong variations in performance including a trade-off between resolution and penetration depth, which could be quantified with our method. This study demonstrates the utility of phantom-based image quality testing in device performance assessment, which may guide development of consensus standards for PAT systems.

Systematic review of colorectal cancer screening guidelines for average-risk adults: Summarizing the current global recommendations.

PubMed

Bénard, Florence; Barkun, Alan N; Martel, Myriam; von Renteln, Daniel

2018-01-07

To summarize and compare worldwide colorectal cancer (CRC) screening recommendations in order to identify similarities and disparities. A systematic literature search was performed using MEDLINE, EMBASE, Scopus, CENTRAL and ISI Web of knowledge identifying all average-risk CRC screening guideline publications within the last ten years and/or position statements published in the last 2 years. In addition, a hand-search of the webpages of National Gastroenterology Society websites, the National Guideline Clearinghouse, the BMJ Clinical Evidence website, Google and Google Scholar was performed. Fifteen guidelines were identified. Six guidelines were published in North America, four in Europe, four in Asia and one from the World Gastroenterology Organization. The majority of guidelines recommend screening average-risk individuals between ages 50 and 75 using colonoscopy (every 10 years), or flexible sigmoidoscopy (FS, every 5 years) or fecal occult blood test (FOBT, mainly the Fecal Immunochemical Test, annually or biennially). Disparities throughout the different guidelines are found relating to the use of colonoscopy, rank order between test, screening intervals and optimal age ranges for screening. Average risk individuals between 50 and 75 years should undergo CRC screening. Recommendations for optimal surveillance intervals, preferred tests/test cascade as well as the optimal timing when to start and stop screening differ regionally and should be considered for clinical decision making. Furthermore, local resource availability and patient preferences are important to increase CRC screening uptake, as any screening is better than none.

Large, Prospective Analysis of the Reasons Patients Do Not Pursue BRCA Genetic Testing Following Genetic Counseling.

PubMed

Hayden, Sommer; Mange, Sarah; Duquette, Debra; Petrucelli, Nancie; Raymond, Victoria M

2017-08-01

Genetic counseling (GC) and genetic testing (GT) identifies high-risk individuals who benefit from enhanced medical management. Not all individuals undergo GT following GC and understanding the reasons why can impact clinical efficiency, reduce GT costs through appropriate identification of high-risk individuals, and demonstrate the value of pre-GT GC. A collaborative project sponsored by the Michigan Department of Health and Human Services prospectively collects anonymous data on BRCA-related GC visits performed by providers in Michigan, including demographics, patient/family cancer history, GT results, and reasons for declining GT. From 2008 to 2012, 10,726 patients underwent GC; 3476 (32.4%) did not pursue GT. Primary reasons included: not the best test candidate (28.1%), not clinically indicated (23.3%), and insurance/out of pocket cost concerns (13.6%). Patient disinterest was the primary reason for declining in 17.1%. Insurance/out of pocket cost concerns were the primary reason for not testing in 13.4% of untested individuals with private insurance. Among untested individuals with breast and/or ovarian cancer, 22.5% reported insurance/out of pocket cost concerns as the primary reason for not testing and 6.6% failed to meet Medicare criteria. In a five-year time period, nearly one-third of patients who underwent BRCA GC did not pursue GT. GT was not indicated in almost half of patients. Insurance/out of pocket cost concerns continue to be barriers.

Preventive Effect of Glycyrrhiza Glabra Extract on Oral Mucositis in Patients Under Head and Neck Radiotherapy: A Randomized Clinical Trial

PubMed Central

Najafi, Shamsolmolok; Koujan, Soraiya Ebrahimpour; Manifar, Soheila; Kharazifard, Mohammad Javad; Kidi, Saba

2017-01-01

Objectives: About two-thirds of cancer patients undergo radiotherapy. Oral mucositis represents a major complication of radiotherapy, causing morbidity and mortality and decreasing the quality of life of patients. This study aimed to assess the preventive effect of Glycyrrhiza aqueous extract on oral mucositis in cancer patients under head and neck radiotherapy. Materials and Methods: In this double-blind clinical trial, 37 head and neck cancer patients were divided into intervention (n=19) group receiving Glycyrrhiza aqueous extract and control (n=18) group receiving placebo. Patients in the test group used Glycyrrhiza aqueous extract topically twice a day from the first day of starting radiotherapy until the end of the second week. Patients were examined in the first day of radiotherapy for any type of wound before treatment and those with oral ulcers before radiotherapy were excluded from the study. The grade of mucositis was determined using the classification by the World Health Organization. ANCOVA was performed to assess any difference between the two groups with regard to oral mucosal irritation and wound size after the intervention while controlling for the covariates such as sex and age. Results: Significant differences were found in the maximum grade of mucositis and oral mucosal irritation between the intervention and control groups (P<0.001). Conclusions: This study showed that aqueous extract of Glycyrrhiza can be effective for decreasing the severity of oral mucositis in head and neck cancer patients undergoing radiotherapy. PMID:29296112

Comparative evaluation of diffusion hypoxia and psychomotor skills with or without postsedation oxygenation following administration of nitrous oxide in children undergoing dental procedures: A clinical study.

PubMed

Khinda, Vineet Inder Singh; Bhuria, Parvesh; Khinda, Paramjit; Kallar, Shiminder; Brar, Gurlal Singh

2016-01-01

Diffusion hypoxia is the most serious potential complication associated with nitrous oxide. It occurs during the recovery period. Hence, administration of 100% oxygen is mandatory as suggested by many authors. The aim of this study is to evaluate the occurrence/nonoccurrence of diffusion hypoxia in two groups of patients undergoing routine dental treatment under nitrous oxide sedation when one group is subjected to 7 min of postsedation oxygenation and the second group of the patients is made to breathe room air for the similar period. A total of sixty patients within the age group of 7-10 years requiring invasive dental procedures were randomly divided into two groups of 30 each using chit method. In the control group, patients were administered 100% oxygen postsedation, whereas, in the study group, patients were made to breathe room air postsedation. Various parameters (pulse rate, respiratory rate, blood pressure, and oxygen saturation [SpO2]) were recorded pre- and post-operatively. Data were collected and then sent for statistical analysis. The mean postoperative SpO2 at measurement times 1, 3, 5, and 7 min in both the groups was higher than the mean preoperative SpO2. This increase was statistically significant. No significant difference was found between the Trieger test scores. This study proves that clinical occurrence of diffusion hypoxia is not possible while following the routine procedure of nitrous oxide sedation.

Rosa Damascena oil improved sexual function and testosterone in male patients with opium use disorder under methadone maintenance therapy-results from a double-blind, randomized, placebo-controlled clinical trial.

PubMed

Farnia, Vahid; Tatari, Faeze; Alikhani, Mostafa; Shakeri, Jalal; Taghizadeh, Moshen; Karbasizadeh, Hassan; Sadeghi Bahmani, Dena; Holsboer-Trachsler, Edith; Brand, Serge

2017-07-01

Some patients with opioid use disorder (OUD) are treated with methadone maintenance therapy (MMT). However, as with opioids, methadone has major side-effects; sexual dysfunction is a particularly distressing such effect. Rosa Damascena oil has been shown to reduce subjective sexual dysfunction in patients with major depressive disorders, but its influence on testosterone has not so far been tested. The aim of the present study was to investigate the influence of Rosa Damascena oil on sexual dysfunction and testosterone levels among male patients with OUD and undergoing MMT. A total of 50 male patients (mean age: 40 years) diagnosed with OUD and receiving MMT were randomly assigned either to the Rosa Damascena oil (drops) or a placebo condition. At baseline, and four and eight weeks later, patients completed questionnaires covering sexual and erectile function. Blood samples to assess testosterone levels were taken at baseline and eight weeks later on completion of the study. Over time sexual dysfunction decreased, and testosterone increased in the Rosa Damascena oil, but not in the placebo condition. Sexual dysfunction scores and testosterone levels were not consistently related. Results from this double-blind, randomized, and placebo-controlled clinical trial showed that Rosa Damascena oil improved sexual function and testosterone levels among males with OUD and undergoing MMT. Copyright © 2017 Elsevier B.V. All rights reserved.

Detection of cervical intraepithelial neoplasias and cancers in cervical tissue by in vivo light scattering

PubMed Central

Mourant, Judith R.; Bocklage, Thérese J.; Powers, Tamara M.; Greene, Heather M.; Dorin, Maxine H.; Waxman, Alan G.; Zsemlye, Meggan M.; Smith, Harriet O.

2009-01-01

Objective To examine the utility of in vivo elastic light scattering measurements to identify cervical intraepithelial neoplasias (CIN) 2/3 and cancers in women undergoing colposcopy and to determine the effects of patient characteristics such as menstrual status on the elastic light scattering spectroscopic measurements. Materials and Methods A fiber optic probe was used to measure light transport in the cervical epithelium of patients undergoing colposcopy. Spectroscopic results from 151 patients were compared with histopathology of the measured and biopsied sites. A method of classifying the measured sites into two clinically relevant categories was developed and tested using five-fold cross-validation. Results Statistically significant effects by age at diagnosis, menopausal status, timing of the menstrual cycle, and oral contraceptive use were identified, and adjustments based upon these measurements were incorporated in the classification algorithm. A sensitivity of 77±5% and a specificity of 62±2% were obtained for separating CIN 2/3 and cancer from other pathologies and normal tissue. Conclusions The effects of both menstrual status and age should be taken into account in the algorithm for classifying tissue sites based on elastic light scattering spectroscopy. When this is done, elastic light scattering spectroscopy shows good potential for real-time diagnosis of cervical tissue at colposcopy. Guiding biopsy location is one potential near-term clinical application area, while facilitating ”see and treat” protocols is a longer term goal. Improvements in accuracy are essential. PMID:20694193

A novel non-imaging optics based Raman spectroscopy device for transdermal blood analyte measurement

PubMed Central

Kong, Chae-Ryon; Barman, Ishan; Dingari, Narahara Chari; Kang, Jeon Woong; Galindo, Luis; Dasari, Ramachandra R.; Feld, Michael S.

2011-01-01

Due to its high chemical specificity, Raman spectroscopy has been considered to be a promising technique for non-invasive disease diagnosis. However, during Raman excitation, less than one out of a million photons undergo spontaneous Raman scattering and such weakness in Raman scattered light often require highly efficient collection of Raman scattered light for the analysis of biological tissues. We present a novel non-imaging optics based portable Raman spectroscopy instrument designed for enhanced light collection. While the instrument was demonstrated on transdermal blood glucose measurement, it can also be used for detection of other clinically relevant blood analytes such as creatinine, urea and cholesterol, as well as other tissue diagnosis applications. For enhanced light collection, a non-imaging optical element called compound hyperbolic concentrator (CHC) converts the wide angular range of scattered photons (numerical aperture (NA) of 1.0) from the tissue into a limited range of angles accommodated by the acceptance angles of the collection system (e.g., an optical fiber with NA of 0.22). A CHC enables collimation of scattered light directions to within extremely narrow range of angles while also maintaining practical physical dimensions. Such a design allows for the development of a very efficient and compact spectroscopy system for analyzing highly scattering biological tissues. Using the CHC-based portable Raman instrument in a clinical research setting, we demonstrate successful transdermal blood glucose predictions in human subjects undergoing oral glucose tolerance tests. PMID:22125761

Better Object Recognition and Naming Outcome With MRI-Guided Stereotactic Laser Amygdalohippocampotomy for Temporal Lobe Epilepsy

PubMed Central

Drane, Daniel L.; Loring, David W.; Voets, Natalie L.; Price, Michele; Ojemann, Jeffrey G.; Willie, Jon T.; Saindane, Amit M.; Phatak, Vaishali; Ivanisevic, Mirjana; Millis, Scott; Helmers, Sandra L.; Miller, John W.; Meador, Kimford J.; Gross, Robert E.

2015-01-01

SUMMARY OBJECTIVES Temporal lobe epilepsy (TLE) patients experience significant deficits in category-related object recognition and naming following standard surgical approaches. These deficits may result from a decoupling of core processing modules (e.g., language, visual processing, semantic memory), due to “collateral damage” to temporal regions outside the hippocampus following open surgical approaches. We predicted stereotactic laser amygdalohippocampotomy (SLAH) would minimize such deficits because it preserves white matter pathways and neocortical regions critical for these cognitive processes. METHODS Tests of naming and recognition of common nouns (Boston Naming Test) and famous persons were compared with nonparametric analyses using exact tests between a group of nineteen patients with medically-intractable mesial TLE undergoing SLAH (10 dominant, 9 nondominant), and a comparable series of TLE patients undergoing standard surgical approaches (n=39) using a prospective, non-randomized, non-blinded, parallel group design. RESULTS Performance declines were significantly greater for the dominant TLE patients undergoing open resection versus SLAH for naming famous faces and common nouns (F=24.3, p<.0001, η2=.57, & F=11.2, p<.001, η2=.39, respectively), and for the nondominant TLE patients undergoing open resection versus SLAH for recognizing famous faces (F=3.9, p<.02, η2=.19). When examined on an individual subject basis, no SLAH patients experienced any performance declines on these measures. In contrast, 32 of the 39 undergoing standard surgical approaches declined on one or more measures for both object types (p<.001, Fisher’s exact test). Twenty-one of 22 left (dominant) TLE patients declined on one or both naming tasks after open resection, while 11 of 17 right (non-dominant) TLE patients declined on face recognition. SIGNIFICANCE Preliminary results suggest 1) naming and recognition functions can be spared in TLE patients undergoing SLAH, and 2) the hippocampus does not appear to be an essential component of neural networks underlying name retrieval or recognition of common objects or famous faces. PMID:25489630

Data of piezoelectric vibration energy harvesting of a bridge undergoing vibration testing and train passage.

PubMed

Cahill, Paul; Hazra, Budhaditya; Karoumi, Raid; Mathewson, Alan; Pakrashi, Vikram

2018-04-01

The data presented in this article is in relation to the research article "Vibration energy harvesting based monitoring of an operational bridge undergoing forced vibration and train passage" Cahill et al. (2018) [1]. The article provides data on the full-scale bridge testing using piezoelectric vibration energy harvesters on Pershagen Bridge, Sweden. The bridge is actively excited via a swept sinusoidal input. During the testing, the bridge remains operational and train passages continue. The test recordings include the voltage responses obtained from the vibration energy harvesters during these tests and train passages. The original dataset is made available to encourage the use of energy harvesting for Structural Health Monitoring.

Duplex Ultrasonography Has Limited Utility in Detection of Postoperative DVT After Primary Total Joint Arthroplasty.

PubMed

Vira, Shaleen; Ramme, Austin J; Alaia, Michael J; Steiger, David; Vigdorchik, Jonathan M; Jaffe, Frederick

2016-07-01

Duplex ultrasound is routinely used to evaluate suspected deep venous thrombosis after total joint arthroplasty. When there is a clinical suspicion for a pulmonary embolism, a chest angiogram (chest CTA) is concomitantly obtained. Two questions were addressed: First, for the population of patients who receive duplex ultrasound after total joint arthroplasty, what is the rate of positive results? Second, for these patients, how many of these also undergo chest CTA for clinical suspicion of pulmonary embolus and how many of these tests are positive? Furthermore, what is the correlation between duplex ultrasound results and chest CTA results? A retrospective chart review was conducted of total joint replacement patients in 2011 at a single institution. Inclusion criteria were adult patients who underwent a postoperative duplex ultrasonography for clinical suspicion of deep venous thrombosis (DVT). Demographic data, result of duplex scan, clinical indications for obtaining the duplex scan, and DVT prophylaxis used were recorded. Additionally, if a chest CTA was obtained for clinical suspicion for pulmonary embolus, results and clinical indication for obtaining the test were recorded. The rate of positive results for duplex ultrasonography and chest CTA was computed and correlated based on clinical indications. Two hundred ninety-five patients underwent duplex ultrasonography of which only 0.7% were positive for a DVT. One hundred three patients underwent a chest CTA for clinical suspicion of a pulmonary embolism (PE) of which 26 revealed a pulmonary embolus, none of which had a positive duplex ultrasound. Postoperative duplex scans have a low rate of positive results. A substantial number of patients with negative duplex results subsequently underwent chest CTA for clinical suspicion for which a pulmonary embolus was found, presumably resulting from a DVT despite negative duplex ultrasound result. A negative duplex ultrasonography should not rule out the presence of a DVT which can embolize to the lungs and thus should not preclude further workup when clinical suspicion exists for a pulmonary embolus.

National Estimates of Genetic Testing in Women With a History of Breast or Ovarian Cancer.

PubMed

Childers, Christopher P; Childers, Kimberly K; Maggard-Gibbons, Melinda; Macinko, James

2017-12-01

Purpose In the United States, 3.8 million women have a history of breast (BC) or ovarian cancer (OC). Up to 15% of cases are attributable to heritable mutations, which, if identified, provide critical knowledge for treatment and preventive care. It is unknown how many patients who are at high risk for these mutations have not been tested and how rates vary by risk criteria. Methods We used pooled cross-sectional data from three Cancer Control Modules (2005, 2010, 2015) of the National Health Interview Survey, a national in-person household interview survey. Eligible patients were adult females with a history of BC and/or OC meeting select 2017 National Comprehensive Cancer Network eligibility criteria on the basis of age of diagnosis and family history. Outcomes included the proportion of individuals reporting a history of discussing genetic testing with a health professional, being advised to undergo genetic testing, or undergoing genetic testing for BC or OC. Results Of 47,218 women, 2.7% had a BC history and 0.4% had an OC history. For BC, 35.6% met one or more select eligibility criteria; of those, 29.0% discussed, 20.2% were advised to undergo, and 15.3% underwent genetic testing. Testing rates for individual eligibility criteria ranged from 6.2% (relative with OC) to 18.2% (diagnosis ≤ 45 years of age). For OC, 15.1% discussed, 13.1% were advised to undergo, and 10.5% underwent testing. Using only four BC eligibility criteria and all patients with OC, an estimated 1.2 to 1.3 million individuals failed to receive testing. Conclusion Fewer than one in five individuals with a history of BC or OC meeting select National Cancer Comprehensive Network criteria have undergone genetic testing. Most have never discussed testing with a health care provider. Large national efforts are warranted to address this unmet need.

Is routine voiding cystourethrogram necessary following double hit for primary vesicoureteral reflux?

PubMed

Arlen, Angela M; Scherz, Hal C; Filimon, Eleonora; Leong, Traci; Kirsch, Andrew J

2015-02-01

Current AUA guidelines recommend voiding cystourethrogram (VCUG) following endoscopic treatment of vesicoureteral reflux (VUR). We evaluated the clinical and radiographic outcomes of children undergoing Double HIT (hydrodistention implantation technique) for primary VUR to determine success rates and the necessity of postoperative VCUG. Children with a history of febrile urinary tract infection (fUTI) undergoing Double HIT for primary VUR between 2009 and 2012 were identified. Patients were prospectively classified as high or low clinical and radiographic risk. Children were categorized as high clinical risk if they had ≥ 3 fUTIs or documented bladder bowel dysfunction (BBD). High radiographic risk included those <2 years of age or with grade 4-5 VUR. Initially, all children underwent postoperative VCUG ("routine" group), while only those with an indication (high radiographic risk or clinical failure) did so during the latter portion of the study ("indicated" group). Clinical success was defined as no postoperative fUTI and radiographic success as negative postoperative VCUG. Average clinical follow-up was 34.7 ± 17.2 months. Two hundred and twenty-two children (198 girls, 24 boys) underwent Double HIT at a mean age of 4.1 ± 2.7 years. Mean maximum VUR grade was 3 ± 0.8. Sixty-eight children (30.6%) had documented BBD. Fourteen children (6.3%) experienced postoperative fUTI, for a clinical success rate of 93.7%. One hundred and fourteen patients (51.4%) underwent postoperative VCUG; 76 were "routine" and 38 were "indicated" [Figure]. Of children classified as low clinical/radiographic risk, 96.6% did not have a postoperative fUTI, compared to 91.1% for high risk patients (P = 0.771). Odds of clinical success for routine VCUG group were 9.9 times higher than for the indicated VCUG group (95% CI, 2-50). Odds of radiographic success for the routine cohort were 13 times higher than for the indicated group (95% CI, 4.2-40). Nine children (4.1%) underwent additional procedures. We found no difference in clinical success among the different risk groups; the number of children with postoperative fUTI was relatively few so there was not statistical power to discern any differences between patients who experienced clinical success versus clinical failure. However, children with an "indicated" VCUG (i.e. those less than 2 years of age, grade 4-5 VUR or those with a fUTI) were 13 times more likely to experience a radiographic failure. This cohort of 38 patients had a 50% radiographic cure rate and a 78.9% clinical cure rate, compared to the overall long-term clinical success rate of 93.7%. Our data demonstrates that we can predict failures with relatively high sensitivity, and it may therefore be prudent to selectively obtain postoperative VCUG rather than recommend it for all children undergoing dextranomer hyaluronic acid co-polymer (Dx/HA) injection. Our study has several limitations that warrant consideration. Not all children underwent a postoperative VCUG, so the true radiographic success rate is unknown. Incidence of fUTI may also be artificially low, as some radiographic failures proceeded directly to another injection or reimplantation. While we were able to demonstrate that children undergoing an "indicated" VCUG were more likely to experience radiographic failure, a larger patient cohort is necessary to determine whether age or VUR grade is more predictive of failure. Finally all patients underwent endoscopic Dx/HA injection, therefore the incidence "spontaneous resolution" is unknown. Long-term clinical success following Double HIT for the endoscopic correction of primary VUR is high, and the majority of children avoid additional procedures. Unless indicated by high-grade, young age, clinical failure, or family/surgeon preference, consideration should be given to making postoperative VCUG an option rather than a recommendation in children undergoing endoscopic treatment of primary VUR using the Double HIT method. Copyright © 2015 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Usefulness of basophil activation test for the diagnosis of IgE mediated hypersensitivity to tetanus toxoid vaccine.

PubMed

Herreros, Blanca; Méndez, Yesica; Feo-Brito, Francisco; Urra, José Miguel

2018-03-01

A great number of vaccinated patients develop specific anti-tetanus toxoid IgE, but usually do not undergo any adverse effect. Most of the allergic reactions to tetanus toxoid vaccine usually present with unspecific symptoms of local inflammation. In the presence of severe reactions, and in a special way if the vaccine is provided together with other drugs, it is difficult to establish which is the harmful drug responsible for IgE-mediated adverse reaction. A patient with an anaphylactic reaction after the administration of Toxoid Tetanic (TT) along with several drugs is described. All skin test were negative. The basophils activation test (BAT) in a clear way, identified TT as the allergen that triggered anaphylaxis. The results achieved demonstrates the usefulness of BAT to clarify patients with hypersensibility to tetanus toxoide when the clinic is severe and the vaccine has been administered together with other drugs. Copyright © 2017 Elsevier B.V. All rights reserved.

Diagnostic use of recombinant Tha p 2 in the allergy to Thaumetopoea pityocampa.

PubMed

Rodríguez-Mahillo, A I; Carballeda-Sangiao, N; Vega, J M; García-Ortiz, J C; Roques, A; Moneo, I; González-Muñoz, M

2015-10-01

Thaumetopoea pityocampa causes allergies and skin and ocular lesions. No commercial tools are currently available for the clinical diagnosis of this allergy. We aimed to develop an in vitro method for the diagnosis of this allergy to avoid patients undergoing in vivo tests with insect extracts. Recombinant Tha p 2 was produced and used in an ELISA validated with 15 allergic patients. Subsequently, 42 subjects recruited from a random sampling cross-sectional study were analysed. The ELISA sensitivity and specificity were 93.3% and 100%, respectively, for the allergic patients and 71.4% and 95.3%, respectively, for the epidemiological study. The positive ELISA results correlated with the skin prick test areas with the whole body and the setae extracts. Professional exposure and short latency of symptoms onset were risk factors for a positive result in the ELISA. In conclusion, our ELISA is very useful for T. pityocampa allergy diagnosis and for epidemiologic testing. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Living at Risk: Concealing Risk and Preserving Hope in Huntington Disease

PubMed Central

Sims, Sharon L.; Swenson, Melinda M.; Harrison, Joan M.; Moskowitz, Carol; Stepanov, Nonna; Suter, Gregory W.; Westphal, Beryl J.

2013-01-01

Much of the qualitative research on Huntington disease has focused on the genetic testing aspects of HD. The overall purpose of this qualitative study was to gather information about the everyday experience of living with the risk of developing Huntington disease in a sample of individuals at risk for HD who have chosen not to pursue genetic testing. Data for this article was obtained from unstructured, open-ended qualitative interviews of a sample of people participating in the PHAROS study. PHAROS, the Prospective Huntington At-Risk Observational Study, is a multi-site study that aims to establish whether experienced clinicians can reliably determine the earliest clinical symptoms of Huntington disease in individuals at 50% risk for HD who have chosen not to undergo genetic testing. Interviews were conducted at six PHAROS research sites across the United States. In this paper, the research team used qualitative description to construct and explore two main themes: (1) careful concealment of risk as an act of self-preservation and (2) preserving hope. PMID:17943424

Safety of a rapid diagnostic protocol with accelerated stress testing.

PubMed

Soremekun, Olan A; Hamedani, Azita; Shofer, Frances S; O'Conor, Katie J; Svenson, James; Hollander, Judd E

2014-02-01

Most patients at low to intermediate risk for an acute coronary syndrome (ACS) receive a 12- to 24-hour "rule out." Recently, trials have found that a coronary computed tomographic angiography-based strategy is more efficient. If stress testing were performed within the same time frame as coronary computed tomographic angiography, the 2 strategies would be more similar. We tested the hypothesis that stress testing can safely be performed within several hours of presentation. We performed a retrospective cohort study of patients presenting to a university hospital from January 1, 2009, to December 31, 2011, with potential ACS. Patients placed in a clinical pathway that performed stress testing after 2 negative troponin values 2 hours apart were included. We excluded patients with ST-elevation myocardial infarction or with an elevated initial troponin. The main outcome was safety of immediate stress testing defined as the absence of death or acute myocardial infarction (defined as elevated troponin within 24 hours after the test). A total of 856 patients who presented with potential ACS were enrolled in the clinical pathway and included in this study. Patients had a median age of 55.0 (interquartile range, 48-62) years. Chest pain was the chief concern in 86%, and pain was present on arrival in 73% of the patients. There were no complications observed during the stress test. There were 0 deaths (95% confidence interval, 0%-0.46%) and 4 acute myocardial infarctions within 24 hours (0.5%; 95% confidence interval, 0.14%-1.27%). The peak troponins were small (0.06, 0.07, 0.07, and 0.19 ng/mL). Patients who present to the ED with potential ACS can safely undergo a rapid diagnostic protocol with stress testing. © 2013.

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

Reiss, T.F.; Golden, J.

Pneumocystis carinii pneumonia was suggested by a diffuse, bilateral pulmonary uptake of gallium-67 in an asymptomatic, homosexual male with the antibody to the immunodeficiency virus (HIV) who was undergoing staging evaluation for lymphoma clinically localized to a left inguinal lymph node. Chest radiograph and pulmonary function evaluation, including lung volumes, diffusing capacity and arterial blood gases, were within normal limits. Bronchoalveolar lavage revealed Pneumocystis carinii organisms. In this asymptomatic, HIV-positive patient, active alveolar infection, evidenced by abnormal gallium-67 scanning, predated pulmonary physiologic abnormalities. This observation raises questions concerning the natural history of this disease process and the specificity of physiologicmore » tests for excluding disease. It also has implications for the treatment of neoplasia in the HIV-positive patient population.« less

[Vasovagal syncope and increased baroreceptor activity: evidence for increased sensibility of the baroreflex and its rapid reversal with acute administration of metoprolol].

PubMed

Pucciarelli, G; De Vecchis, R; Ebraio, F; Corigliano, G G

1997-07-01

In 17 patients suffering from recurrent episodes of vasovagal syncope as well as in 21 healthy subjects without clinical episodes of presyncope or syncope, we evaluated the reflex decrease in heart rate evoked by the phenilephrine test. In the syncopal patients, the measurements were taken 4-12 hours after the clinical appearance of syncope. We divided the syncopal patients as follows: 9 patients, undergoing pharmacological treatment, and 8 untreated patients (drug free arm). In the pharmacological arm of the study, an alternate, randomized administration of metoprolol (150 mg twice daily for 2 days) and verapamil (80 mg every 6 hours for 2 days) was provided. Therefore, in the pharmacological arm as well as in drug free patients, we tested again the baroreflex sensitivity, by means of iv phenilephrine bolus, 3 and 7 days after the clinical appearance of the syncopal event. The baroreflex sensitivity values were significantly higher in the syncopal group compared to the control group (21 +/- 5 vs 13 +/- 4.5 ms/mm Hg; p < 0.01). Of the two tested drugs, only the metoprolol produced a fast (day 3) decrease in baroreflex sensitivity. On the basis of measurements taken after 7 days, we noted a pattern of widespread reduction in baroreflex sensitivity values, found in both treated and untreated patients. In conclusion, patients with vasovagal syncope exhibited a more pronounced maximal parasympathetic activation compared to the control group. The high baroreflex sensitivity values were soon (day 3) reduced by metoprolol, but not by verapamil therapy; a spontaneous normalization in baroreflex sensitivity values was found 7 days after the clinical episode, regardless of therapy.

Use of gonioscopy in medicare beneficiaries before glaucoma surgery.

PubMed

Coleman, Anne L; Yu, Fei; Evans, Stacy J

2006-12-01

The American Academy of Ophthalmology Preferred Practice Patterns for angle closure and open-angle glaucoma (OAG) patients recommends performing bilateral gonioscopy upon initial presentation to evaluate the possibility of narrow angle or angle-closure glaucoma (ACG) and then repeating the examination at least every 5 years. This study aims to assess how commonly eye care providers perform gonioscopy before planned glaucoma surgery in OAG, anatomic narrow angle, and ACG in the Medicare population. Data obtained from a 5% random sample of Medicare beneficiaries undergoing glaucoma surgery in the United States in 1999 were retrospectively reviewed. The proportion of patients with evidence of at least one gonioscopic examination before glaucoma surgery was determined for the period of 1995 to 1999. Demographic and clinical factors potentially influencing the decision to perform gonioscopy were also examined. Overall, gonioscopy is apparently performed in 49% of Medicare beneficiaries during the 4 to 5 years preceding glaucoma surgery. This rate was significantly lower (P < 0.001) in patients with OAG (46%), as compared with anatomic narrow angle (58%) and ACG (57%) patients. Hispanics, elderly (aged 70 to 84), patients undergoing laser iridotomy, and patients receiving care in the New York/New Jersey area all had significantly higher apparent preoperative gonioscopy rates (P < 0.05). Gonioscopy examination before glaucoma surgery in Medicare beneficiaries is underused, undercoded, and/or miscoded, given current recommendations. Underuse is of particular concern in patients undergoing laser iridotomy as it is the diagnostic test of choice in ACG.

Angiographic and Clinical Impact of Successful Manual Thrombus Aspiration in Diabetic Patients Undergoing Primary PCI

PubMed Central

2014-01-01

Background. Diabetes mellitus is associated with worse angiographic and clinical outcomes after percutaneous coronary intervention (PCI). Aim. To investigate the impact of manual thrombus aspiration on in-stent restenosis (ISR) and clinical outcome in patients treated by bare-metal stent (BMS) implantation for ST-segment elevation myocardial infarction (STEMI). Methods. 100 diabetic patients were prospectively enrolled. They were randomly assigned to undergo either standard primary PCI (group A, 50 patients) or PCI with thrombus aspiration using Export catheter (group B, 50 patients). The primary endpoint was the rate of eight-month ISR. The secondary endpoint included follow-up for major adverse cardiac events (MACE). Results. Mean age of the study cohort was 59.86 ± 8.3 years, with 64 (64%) being males. Baseline characteristics did not differ between both groups. Eight-month angiogram showed that group B patients had significantly less late lumen loss (0.17 ± 0.35 versus 0.60 ± 0.42 mm, P < 0.001), with lower incidence of ISR (4% versus 16.6%, P < 0.001). There was a trend towards lower rate of MACE in the same group of patients. Conclusion. In diabetic patients undergoing primary PCI, manual thrombus aspiration (compared with standard PCI) was associated with better ISR rate after BMS implantation. PMID:24804102

Impact of Tranexamic Acid in Total Knee and Total Hip Replacement.

PubMed

Boyle, Jaclyn A; Soric, Mate M

2017-02-01

To evaluate the net clinical benefit of tranexamic acid use in patients undergoing total knee or total hip replacement. This is a retrospective study of patients undergoing total knee or total hip replacement. The primary outcome was the net clinical benefit of tranexamic acid use. Secondary outcomes included length of stay, incidence of venous thromboembolism, change in hemoglobin, and number of units of blood transfused. Four hundred and six patients were screened for inclusion and 327 patients met inclusion criteria; 174 patients received tranexamic acid versus 153 patients who received usual care. Tranexamic acid demonstrated a positive net clinical benefit versus usual care (40.8% vs 13.7%, P < .01) but did not affect length of stay (3.39 vs 3.37 days, respectively, P = .76). Venous thromboembolism was comparable between groups (2.3% vs 0.7%, P = .38). Average change in hemoglobin and need for transfusion were lower in the treatment group versus the usual care group, respectively (3.46 vs 4.26 mg/dL, P < .01). Tranexamic acid demonstrated a significant benefit in decreasing change in hemoglobin as well as the need for blood transfusion with no increase in the risk of venous thromboembolism in patients undergoing total knee or total hip replacement.

Termite testing continues

Treesearch

Terence L. Wagner; Joe Mulrooney; Chris Petereson

2002-01-01

The United States Department of Agriculture Forest Service's termiticide testing program provides unbiased efficacy data for product registration using standardized tests, sites and evaluation procedures. Virtually all termiticides undergo Forest Service tests prior to registration.