The Minimal Clinically Important Difference for the Mayo-Portland Adaptability Inventory.

PubMed

Malec, James F; Kean, Jacob; Monahan, Patrick O

To determine the Minimal Clinically Important Difference (MCID) and Robust Clinically Important Difference (RCID) of the Mayo-Portland Adaptability Inventory-4 (MPAI-4) as measures of response to intervention. Retrospective analysis of existing data. Both distribution- and anchor-based methods were used to triangulate on the MCID and to identify a moderate, that is, more robust, level of change (RCID) for the MPAI-4. These were further evaluated with respect to clinical provider ratings. Data for individuals with acquired brain injury in rehabilitation programs throughout the United States in the OutcomeInfo Database (n = 3087) with 2 MPAI-4 ratings. MPAI-4, Supervision Rating Scale, Clinician Rating of Global Clinical Improvement. Initial analyses suggested 5 T-score points (5T) as the MCID and 9T as the RCID. Eighty-one percent to 87% of clinical raters considered a 5T change and 99% considered a 9T change to indicate meaningful improvement. 5T represents the MCID for the MPAI-4 and 9T, the RCID. Both values are notably less than the Reliable Change Index (RCI). While the RCI indicates change with a high level of statistical confidence, it may be insensitive to change that is considered meaningful by providers and participants as indicated by the MCID.

Approaches for estimating minimal clinically important differences in systemic lupus erythematosus.

PubMed

Rai, Sharan K; Yazdany, Jinoos; Fortin, Paul R; Aviña-Zubieta, J Antonio

2015-06-03

A minimal clinically important difference (MCID) is an important concept used to determine whether a medical intervention improves perceived outcomes in patients. Prior to the introduction of the concept in 1989, studies focused primarily on statistical significance. As most recent clinical trials in systemic lupus erythematosus (SLE) have failed to show significant effects, determining a clinically relevant threshold for outcome scores (that is, the MCID) of existing instruments may be critical for conducting and interpreting meaningful clinical trials as well as for facilitating the establishment of treatment recommendations for patients. To that effect, methods to determine the MCID can be divided into two well-defined categories: distribution-based and anchor-based approaches. Distribution-based approaches are based on statistical characteristics of the obtained samples. There are various methods within the distribution-based approach, including the standard error of measurement, the standard deviation, the effect size, the minimal detectable change, the reliable change index, and the standardized response mean. Anchor-based approaches compare the change in a patient-reported outcome to a second, external measure of change (that is, one that is more clearly understood, such as a global assessment), which serves as the anchor. Finally, the Delphi technique can be applied as an adjunct to defining a clinically important difference. Despite an abundance of methods reported in the literature, little work in MCID estimation has been done in the context of SLE. As the MCID can help determine the effect of a given therapy on a patient and add meaning to statistical inferences made in clinical research, we believe there ought to be renewed focus on this area. Here, we provide an update on the use of MCIDs in clinical research, review some of the work done in this area in SLE, and propose an agenda for future research.

Platelet Immunology in China: Research and Clinical Applications.

PubMed

Wu, Guoguang; Zhou, Yan; Li, Lilan; Zhong, Zhoulin; Li, Hengchong; Li, Haiyan; Yu, Mei; Shen, Weidong; Ni, Heyu

2017-04-01

Immunization against human platelet alloantigens (HPAs) is associated with a number of clinical complications. The detection and identification of clinically relevant platelet antibodies are important for the diagnosis and management of patients affected with immune-mediated thrombocytopenias. Human platelet alloantigen frequencies and the characteristics of antiplatelet antibodies vary widely between ethnic groups. Since 2008, the importance of platelet immunology in the field of transfusion medicine has gained greater recognition by clinical laboratories in China. Laboratories in China have established and improved methods for platelet antibody detection and HPA genotyping techniques, which are used for the diagnosis of alloimmune platelet disorders in clinic and research environments. Research has revealed the frequencies of HPA alleles in different Chinese ethnic groups and compared the differences in HPA gene frequencies between the Chinese Han and other ethnic groups of the world. Production of anti-CD36 isoantibodies is an important risk factor for immune-mediated thrombocytopenia in the Chinese population. Advances in research and clinical application of platelet immunology have significantly improved the clinical diagnosis, treatment including transfusion support, and prevention of alloimmune platelet disorders in the Chinese population. Copyright © 2017. Published by Elsevier Inc.

Achieving progress through clinical governance? A national study of health care managers' perceptions in the NHS in England

PubMed Central

Freeman, T; Walshe, K

2004-01-01

Background: A national cross sectional study was undertaken to explore the perceptions concerning the importance of, and progress in, aspects of clinical governance among board level and directorate managers in English acute, ambulance, and mental health/learning disabilities (MH/LD) trusts. Participants: A stratified sample of acute, ambulance, and mental health/learning disabilities trusts in England (n = 100), from each of which up to 10 board level and 10 directorate level managers were randomly sampled. Methods: Fieldwork was undertaken between April and July 2002 using the Organisational Progress in Clinical Governance (OPCG) schedule to explore managers' perceptions of the importance of, and organisational achievement in, 54 clinical governance competency items in five aggregated domains: improving quality; managing risks; improving staff performance; corporate accountability; and leadership and collaboration. The difference between ratings of importance and achievement was termed a shortfall. Results: Of 1916 individuals surveyed, 1177 (61.4%) responded. The competency items considered most important and recording highest perceived achievement related to corporate accountability structures and clinical risks. The highest shortfalls between perceived importance and perceived achievement were reported in joint working across local health communities, feedback of performance data, and user involvement. When aggregated into domains, greatest achievement was perceived in the assurance related areas of corporate accountability and risk management, with considerably less perceived achievement and consequently higher shortfalls in quality improvement and leadership and collaboration. Directorate level managers' perceptions of achievement were found to be significantly lower than those of their board level colleagues on all domains other than improving performance. No differences were found in perceptions of achievement between different types of trusts, or between trusts at different stages in the Commission for Health Improvement (CHI) review cycle. Conclusions: While structures and systems for clinical governance seem well established, there is more perceived progress in areas concerned with quality assurance than quality improvement. This study raises some uncomfortable questions about the impact of CHI review visits. PMID:15465936

Achieving progress through clinical governance? A national study of health care managers' perceptions in the NHS in England.

PubMed

Freeman, T; Walshe, K

2004-10-01

A national cross sectional study was undertaken to explore the perceptions concerning the importance of, and progress in, aspects of clinical governance among board level and directorate managers in English acute, ambulance, and mental health/learning disabilities (MH/LD) trusts. A stratified sample of acute, ambulance, and mental health/learning disabilities trusts in England (n = 100), from each of which up to 10 board level and 10 directorate level managers were randomly sampled. Fieldwork was undertaken between April and July 2002 using the Organisational Progress in Clinical Governance (OPCG) schedule to explore managers' perceptions of the importance of, and organisational achievement in, 54 clinical governance competency items in five aggregated domains: improving quality; managing risks; improving staff performance; corporate accountability; and leadership and collaboration. The difference between ratings of importance and achievement was termed a shortfall. Of 1916 individuals surveyed, 1177 (61.4%) responded. The competency items considered most important and recording highest perceived achievement related to corporate accountability structures and clinical risks. The highest shortfalls between perceived importance and perceived achievement were reported in joint working across local health communities, feedback of performance data, and user involvement. When aggregated into domains, greatest achievement was perceived in the assurance related areas of corporate accountability and risk management, with considerably less perceived achievement and consequently higher shortfalls in quality improvement and leadership and collaboration. Directorate level managers' perceptions of achievement were found to be significantly lower than those of their board level colleagues on all domains other than improving performance. No differences were found in perceptions of achievement between different types of trusts, or between trusts at different stages in the Commission for Health Improvement (CHI) review cycle. While structures and systems for clinical governance seem well established, there is more perceived progress in areas concerned with quality assurance than quality improvement. This study raises some uncomfortable questions about the impact of CHI review visits.

Survey of clinical practice for irritable bowel syndrome in East asian countries.

PubMed

Fukudo, Shin; Hahm, Ki-Baik; Zhu, Qi; Sollano, Jose D; Rani, Abdul A; Syam, Ari F; Kachintorn, Udom; Suzuki, Hidekazu; Kamiya, Takeshi; Joh, Takashi; Uchiyama, Kazuhiko; Naito, Yuji; Takahashi, Shin'ichi; Kinoshita, Yoshikazu; Ueno, Fumiaki; Yamagami, Hirokazu; Chan, Francis K L; Fock, Kwong M; Arakawa, Tetsuo

2015-01-01

Sociocultural factors are important because their different effects on the features of irritable bowel syndrome (IBS) between countries will provide clues towards solving this problem. The aims of this study were to depict the clinical realities of IBS in East Asian countries and test the hypothesis that the diagnosis and treatment of IBS differ between countries. Study participants were 251 physicians involved in the clinical practice of IBS at major institutions in Japan, South Korea, China, the Philippines, Indonesia and Singapore. The questionnaire contained 45 questions focused on the clinical practice of IBS. Subjects in Japan, South Korea, China, Indonesia, the Philippines and Singapore accounted for 55.4, 17.9, 8.8, 8.0, 6.4 and 3.6% of the study cohort, respectively. Amongst East Asian physicians, the most important symptom was considered to be abdominal pain by 33.4%, whilst 24.3% regarded alternating diarrhea and constipation to be the most important symptoms. Total colonoscopy and histopathology use showed no difference among countries. Prescriptions given for mild (p < 0.0001), moderate (p < 0.0001), severe (p < 0.0001), intractable (p = 0.002), diarrheal (p < 0.0001) and constipating (p < 0.0001) patients with IBS significantly differed between the countries. Except for several minor points, IBS specialists showed no significant difference in their diagnosis and treatment of IBS when compared to nonspecialists. This survey provided data on the clinical treatment of IBS among East Asian countries. The results supported the hypothesis that the diagnosis and treatment of IBS differs between countries. © 2015 S. Karger AG, Basel.

Childhood Hemorrhagic Stroke: An Important but Understudied Problem

PubMed Central

Lo, Warren

2013-01-01

Hemorrhagic stroke in children occurs more frequently than is commonly appreciated. There are important differences in the factors associated with hemorrhagic stroke in children when compared with adults. These differences likely play a role in the different outcomes, which tend to worsen with age. In this review, we describe the estimated frequency, clinical presentation, acute management of hemorrhagic stroke, and an overview of rehabilitation techniques. We identify key topics for future basic and clinical research. Findings from future studies will help improve our ability to optimize treatment for and long-term rehabilitation of these patients. PMID:21633104

Neuropathological Assessment as an Endpoint in Clinical Trial Design.

PubMed

Gentleman, Steve; Liu, Alan King Lun

2018-01-01

Different neurodegenerative conditions can have complex, overlapping clinical presentations that make accurate diagnosis during life very challenging. For this reason, confirmation of the clinical diagnosis still requires postmortem verification. This is particularly relevant for clinical trials of novel therapeutics where it is important to ascertain what disease and/or pathology modifying effects the therapeutics have had. Furthermore, it is important to confirm that patients in the trial actually had the correct clinical diagnosis as this will have a major bearing on the interpretation of trial results. Here we present a simple protocol for pathological assessment of neurodegenerative changes.

Sex and gender differences in pain and analgesia.

PubMed

Mogil, Jeffrey S; Bailey, Andrea L

2010-01-01

It is a clinical reality that women make up the large majority of chronic pain patients, and there is now consensus from laboratory experiments that when differences are seen, women are more sensitive to pain than men. Research in this field has now begun to concentrate on finding explanations for this sex difference. Although sex differences in sociocultural, psychological, and experiential factors likely play important roles, evidence largely from animal studies has revealed surprisingly robust and often qualitative sex differences at low levels of the neuraxis. Although not yet able to affect clinical practice, the continued study of sex differences in pain may have important implications for the development of new analgesic strategies. Copyright © 2010 Elsevier B.V. All rights reserved.

[Prescribing monitoring in clinical practice: from enlightened empiricism to rational strategies].

PubMed

Buclin, Thierry; Herzig, Lilli

2013-05-15

Monitoring of a medical condition is the periodic measurement of one or several physiological or biological variables to detect a signal regarding its clinical progression or its response to treatment. We distinguish different medical situations between diagnostic, clinical and therapeutic process to apply monitoring. Many clinical, variables can be used for monitoring, once their intrinsic properties (normal range, critical difference, kinetics, reactivity) and external validity (pathophysiological importance, predictive power for clinical outcomes) are established. A formal conceptualization of monitoring is being developed and should support the rational development of monitoring strategies and their validation through appropriate clinical trials.

Jewish physicians' beliefs and practices regarding religion/spirituality in the clinical encounter.

PubMed

Stern, Robert M; Rasinski, Kenneth A; Curlin, Farr A

2011-12-01

We used data from a 2003 survey of US physicians to examine differences between Jewish and other religiously affiliated physicians on 4-D of physicians' beliefs and practices regarding religion and spirituality (R/S) in the clinical encounter. On each dimension, Jewish physicians ascribed less importance to the effect of R/S on health and a lesser role for physicians in addressing R/S issues. These effects were partially mediated by lower levels of religiosity among Jewish physicians and by differences in demographic and practice-level characteristics. The study provides a salient example of how religious affiliation can be an important independent predictor of physicians' clinically-relevant beliefs and practices.

Jewish Physicians' Beliefs and Practices Regarding Religion/Spirituality in the Clinical Encounter

PubMed Central

Stern, Robert M.; Rasinski, Kenneth A.; Curlin, Farr A.

2013-01-01

We used data from a 2003 survey of US physicians to examine differences between Jewish and other religiously affiliated physicians on 4-D of physicians' beliefs and practices regarding religion and spirituality (R/S) in the clinical encounter. On each dimension, Jewish physicians ascribed less importance to the effect of R/S on health and a lesser role for physicians in addressing R/S issues. These effects were partially mediated by lower levels of religiosity among Jewish physicians and by differences in demographic and practice-level characteristics. The study provides a salient example of how religious affiliation can be an important independent predictor of physicians' clinically-relevant beliefs and practices. PMID:21706257

The value of LGI1, Caspr2 and voltage-gated potassium channel antibodies in encephalitis.

PubMed

van Sonderen, Agnes; Petit-Pedrol, Mar; Dalmau, Josep; Titulaer, Maarten J

2017-05-01

The discovery, in 2010, of autoantibodies against the extracellular proteins LGI1 and Caspr2 facilitated a change of view regarding the clinical importance of voltage-gated potassium channel (VGKC) antibodies. Currently, these antibodies are all classified as VGKC-complex antibodies, and are commonly considered to have a similar clinical value. However, studies from the past few years show that the immune responses mediated by these antibodies have differing clinical relevance. Here, we review the clinical importance of these immune responses in three settings: patients with anti-LGI1 antibodies, patients with anti-Caspr2 antibodies, and patients with antibodies against the VGKC complex that lack LGI1 and Caspr2 specificity. Antibodies against LGI1 and Caspr2 are associated with different but well-defined syndromes, whereas the clinical importance of VGKC-complex antibodies without LGI1 and Caspr2 specificity is questionable. We describe each of these syndromes, discuss the function of the target antigens and review the limited paediatric literature on the topic. The findings emphasize the importance of defining these disorders according to the molecular identity of the targets (LGI1 or Caspr2), and caution against the use of VGKC-complex antibodies for the diagnosis and treatment of patients without further definition of the antigen.

A systematic review of the association between radiographic and clinical osteoarthritis of hip and knee.

PubMed

Kinds, M B; Welsing, P M J; Vignon, E P; Bijlsma, J W J; Viergever, M A; Marijnissen, A C A; Lafeber, F P J G

2011-07-01

There is ongoing debate on whether an association between radiographic and clinical osteoarthritis (OA) exists. We hypothesized that the inconsistency in the detection of an association might be caused by different definitions of OA, by different radiographic protocols, and by scoring methods for radiographic damage and symptoms. The goal of this study was to evaluate which methodological criteria are important to detect an association between radiographic and clinical OA of hip and knee. A literature search was performed with the keywords 'OA', 'hip', 'knee', 'radiographic', and 'clinical' and results were screened for relevant studies. Quality criteria for study characteristics and methodology were developed. Studies were classified according to these criteria and the presence of an association between radiographic and clinical OA was scored. The importance of methodological quality and patient characteristics on the presence of an association was evaluated. The literature search resulted in 39 studies describing an association between radiographic and clinical OA. The frequency of an association between radiographic and clinical OA outcome measures diminished when less quality criteria were fulfilled. Specifically the criterion for standardized outcome measures appeared important in the detection of an association. The association was not influenced by patient characteristics. Only four studies were identified that fulfilled all quality criteria and in these studies an association was found for the knee joint and an inconsistent association was found for the hip joint. Methodological quality criteria are of importance to reveal an association between radiographic and clinical OA. Copyright © 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders.

PubMed

Farrar, John T; Pritchett, Yili L; Robinson, Michael; Prakash, Apurva; Chappell, Amy

2010-02-01

Data on 1,700 patients pooled from 5 randomized, placebo-controlled duloxetine studies (3 in diabetic peripheral neuropathic pain and 2 in fibromyalgia) were analyzed to determine clinically important differences (CIDs) in the 0 to 10 Numeric Rating Scale-Pain Intensity (NRS-PI) for patient-reported "worst" and "least" pain intensity while validating the previously published level for "average" pain. The correspondence between the baseline-to-endpoint raw and percentage change in the NRS-PI for the worst, least, and average pain were compared to patients' perceived improvements at endpoint as measured by the 7-point Patient Global Impression of Improvement (PGI-I) scales. Stratification by baseline pain separated the raw but not the percent change scores. The PGI-I category of "much better" or above was our a priori definition of a CID. Cutoff points for the NRS-PI change scores were determined using a receiver operator curve analysis. A consistent relationship between the worst and average NRS-PI percent change and the PGI-I was demonstrated regardless of the study, pain type, age, sex, or treatment group with a reduction of approximately 34%. The least pain item CID was slightly higher at 41%. Raw change CID cutoff points were approximately -2, -2.5 and -3 for least, average, and worst pain respectively. We determined an anchor-based value for the change in the worst, least, and average pain intensity items of the Brief Pain Inventory that best represents a clinically important difference. Our findings support a standard definition of a clinically important difference in clinical trials of chronic-pain therapies. Copyright 2010 American Pain Society. Published by Elsevier Inc. All rights reserved.

Training and orthotic effects related to functional electrical stimulation of the peroneal nerve in stroke.

PubMed

Street, Tamsyn; Swain, Ian; Taylor, Paul

2017-01-31

To examine the evidence for a training effect on the lower limb of functional electrical stimulation. Cohort study. A total of 133 patients >6 months post-stroke. Training and orthotic effects were determined from walking speed over 10 m, associated minimal and substantial clinically important differences (i.e. >0.05 and >0.10 m/s), and Functional Ambulation Category (FAC), ranging from household walking to independent walking in the community. An overall significant (p < 0.01) training effect was found that was not a clinically important difference (0.02 m/s); however, "community" FAC (≥ 0.8 m/s) and "most limited community walkers" FAC (0.4-0.58 m/s), but not "household walkers" (< 0.4 m/s), benefitted from a clinically important difference. A highly significant (p< 0.001), substantial clinically important orthotic effect (0.10 m/s) was found. In terms of overall improvement of one or more FACs, 23% achieved this due to a training effect, compared with 43% due to an orthotic effect. The findings suggest that functional electrical stimulation provides a training effect in those who are less impaired. Further work, which optimizes the use of the device for restoration of function, rather than as an orthotic device, will provide greater clarity on the effectiveness of functional electrical stimulation for eliciting a training effect.

Minimum Clinically Important Difference and Substantial Clinical Benefit in Pain, Functional, and Quality of Life Scales in Failed Back Surgery Syndrome Patients.

PubMed

Park, Ki Byung; Shin, Joon-Shik; Lee, Jinho; Lee, Yoon Jae; Kim, Me-Riong; Lee, Jun-Hwan; Shin, Kyung-Min; Shin, Byung-Cheul; Cho, Jae-Heung; Ha, In-Hyuk

2017-04-15

.: Prospective observational 1-year study. .: To determine minimum clinically important difference (MCID) and substantial clinical benefit (SCB) of outcome measures in failed back surgery syndrome (FBSS) patients, as these metrics enable assessment of whether and when an intervention produces clinically meaningful effects in a patient. .: Several methods have been devised to quantify clinically important difference, but MCID and SCB for FBSS patients has yet to be determined. .: Patients with persisting/recurrent low back pain (LBP) and/or leg pain after lumbar surgery who completed 16 weeks of treatment (n = 105) at two hospitals in Korea from November 2011 to September 2014 were analyzed. Global perceived effect was used to determine receiver operating characteristic curves in visual analogue scale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) in an anchor-based approach. .: MCIDs for ODI, LBP and leg pain VAS, physical component summary, mental health component summary (MCS), and overall health scores of SF-36 were 9.0, 22.5, 27.5, 10.2, 4.0, and 8.9, and SCBs were 15.0, 32.5, 37.0, 19.7, 19.3, and 21.1, respectively. MCID and SCB area under the curve was ≥0.8, and ≥0.7, respectively. .: LBP and leg pain VAS, ODI, and physical component summary of SF-36 may be used to measure responsiveness in FBSS patients. 3.

The importance of intuition in the occupational medicine clinical consultation.

PubMed

Philipp, R; Philipp, E; Thorne, P

1999-01-01

Clinical consultation involves unspoken elements which flow between doctor and patient. They are vital ingredients of successful patient management but are not easily measured, objective or evidence-based. These elements include empathy and intuition for what the patient is experiencing and trying to express, or indeed suppressing. Time is needed to explore the instinctive feeling for what is important, particularly in present day society which increasingly recognizes the worth of psychosocial factors. This time should be available in the occupational health consultation. In this paper the importance of intuition and its essential value in the clinical interview are traced through history. Differences between intuition and empathy are explored and the use of intuition as a clinical tool is examined.

Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals.

PubMed

McNair, Angus G K; Brookes, Sara T; Whistance, Robert N; Forsythe, Rachael O; Macefield, Rhiannon; Rees, Jonathan; Jones, James; Smith, George; Pullyblank, Anne M; Avery, Kerry N L; Thomas, Michael G; Sylvester, Paul A; Russell, Anne; Oliver, Alfred; Morton, Dion; Kennedy, Robin; Jayne, David G; Huxtable, Richard; Hackett, Rowland; Dutton, Susan J; Coleman, Mark G; Card, Mia; Brown, Julia; Blazeby, Jane M

2016-07-25

Trials are robust sources of data for clinical practice; however, trial outcomes may not reflect what is important to communicate for decision-making. The study compared clinicians' views of outcomes to include in a core outcome set for colorectal cancer (CRC) surgery, with what clinicians considered important information for clinical practice (core information). Potential outcome/information domains were identified through systematic literature reviews, reviews of hospital information leaflets and interviews with patients. These were organized into six categories and used to design a questionnaire survey that asked surgeons and nurses from a sample of CRC centers to rate the importance of each domain as an outcome or as information on a nine-point Likert scale. Respondents were re-surveyed (round 2) following group feedback (Delphi methods). Comparisons were made by calculating the difference in mean scores between the outcomes and information domains, and paired t tests were used to explore the difference between mean scores of the six outcome/information categories. Data sources identified 1216 outcome/information items for CRC surgery that informed a 94-item questionnaire. First-round questionnaires were returned from 63/81 (78 %) of centers. Clinicians rated 76/94 (84 %) domains of higher importance to measure in trials than information to communicate to patients in round 1. This was reduced to 24/47 (51 %) in round 2. The greatest difference was evident in domains regarding survival, which was rated much more highly as a trial outcome than an important piece of information for decision-making (difference in mean 2.3, 95 % CI 1.9 to 2.8, p <0.0001). Specific complications and quality-of-life domains were rated similarly (difference in mean 0.18, 95 % CI -0.1 to 0.4, p = 0.2 and difference in mean 0.2, 95 % CI -0.1 to 0.5, p = 0.2, respectively). Whilst clinicians want to measure key outcomes in trials, they rate these as less important to communicate in decision-making with patients. This discrepancy needs to be explored and addressed to maximize the impact of trials on clinical practice.

[Childhood scabies: a different entity].

PubMed

Níguez Carbonell, J C; García-Marcos Alvarez, L; Sebastián Raz, J M; García Marcos, V; Guillén Pérez, J J

1988-01-01

Epidemiological, clinical, diagnostic and therapeutic aspects that make scabies a clinical entity with a special personality in the pediatric field, are reviewed. On the epidemiological aspects, a special mention of its unsuspected frequency in this age is made. Scabies is an endemic disease in our country among the more deprived people. On the clinical aspects, the great importance of clinical history and distribution of skin lesions for the early diagnosis is pointed out. Some "alert pointers" are described for this early diagnosis. On the therapeutic field, the importance of the primary care prevention is discussed, and the drug approach for its relieve is commented.

Clinical supervision: an important part of every nurse's practice.

PubMed

Bifarin, Oladayo; Stonehouse, David

2017-03-23

Clinical supervision involves a supportive relationship between supervisor and supervisee that facilitates reflective learning and is part of professional socialisation. Clinical supervision can take many different forms and may be adapted to suit local circumstances. A working agreement is required between the parties to the supervision and issues surrounding confidentiality must be understood. High-quality clinical supervision leads to greater job satisfaction and less stress. When it is absent or inadequate, however, the results can be serious and it is particularly important that student nurses are well supported in this way. Further research in this area is necessary.

Medical paraclinical standards, political economy of clinic, and patients' clinical dependency; a critical conversation analysis of clinical counseling in South of iran.

PubMed

Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

2014-07-01

Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. RESULTS show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Although we can't condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can't reduce it to instrumental and linear methods of body treatment.

A Slovenian version of the "clinical learning environment, supervision and nurse teacher scale (Cles+T)" and its comparison with the Croatian version.

PubMed

Žvanut, Boštjan; Lovrić, Robert; Kolnik, Tamara Štemberger; Šavle, Majda; Pucer, Patrik

2018-05-01

Nursing clinical learning environments are particularly important for the achievement of good practice in clinical training of student nurses, and thus, for the nursing competence development. Hence, it is important to have an instrument consisting of reliable and valid criteria for assessing the clinical learning environment, applicable in different contexts, and translated in the respondents mother tongue. The goal of the present research was to test the reliability and validity of the Slovenian version of the "Clinical Learning Environment, Supervision and Nurse Teacher evaluation scale", and to compare it with the Croatian version. The data was collected between 10 March and 10 June 2015 at four Slovenian institutions, where nursing BSc study programmes are performed. The final sample consisted of 232 students (response rate 68.8%): 81.9% were females and 18.1% males, average age was 23. The translated instrument in Slovenian language resulted as reliable and valid, it reflects the expected five factors of the original version despite some minor problems in the factor structure and in test-retest. The most important difference between the Slovenian and Croatian version is in the factor structure regarding the implementation of roles in clinical learning environment. Copyright © 2018 Elsevier Ltd. All rights reserved.

The Potential Role of Aurora Kinase Inhibitors in Haematological Malignancies

PubMed Central

Farag, Sherif S.

2011-01-01

Summary Aurora kinases play an important role in the control of the cell cycle and have been implicated in tumourigenesis in a number of cancers. Among the haematological malignancies, overexpression of Aurora kinases has been reported in acute myeloid leukaemia, chronic myeloid leukaemia, acute lymphoblastic leukaemia, multiple myeloma, aggressive non-Hodgkin lymphoma and Hodgkin lymphoma. A large number of Aurora kinase inhibitors are currently in different stages of clinical development. In addition to varying in their selectivity for the different Aurora kinases, some also have activity directed at other cellular kinases involved in important molecular pathways in cancer cells. This review summarizes the biology of Aurora kinases and discusses why they may be good therapeutic targets in different haematological cancers. We describe preclinical data that has served as the rationale for investigating Aurora kinase inhibitors in different haematological malignancies, and summarize published results from early phase clinical trials. While the anti-tumour effects of Aurora kinase inhibitors appear promising, we highlight important issues for future clinical research and suggest that the optimal use of these inhibitors is likely to be in combination with cytotoxic agents already in use for the treatment of various haematological cancers. PMID:21980926

The roles of deliberate practice and innate ability in developing expertise: evidence and implications.

PubMed

Kulasegaram, Kulamakan M; Grierson, Lawrence E M; Norman, Geoffrey R

2013-10-01

Medical education research focuses extensively on experience and deliberate practice (DP) as key factors in the development of expert performance. The research on DP minimises the role of individual ability in expert performance. This claim ignores a large body of research supporting the importance of innate individual cognitive differences. We review the relationship between DP and an innate individual ability, working memory (WM) capacity, to illustrate how both DP and individual ability predict expert performance. This narrative review examines the relationship between DP and WM in accounting for expert performance. Studies examining DP, WM and individual differences were identified through a targeted search. Although all studies support extensive DP as a factor in explaining expertise, much research suggests individual cognitive differences, such as WM capacity, predict expert performance after controlling for DP. The extent to which this occurs may be influenced by the nature of the task under study and the cognitive processes used by experts. The importance of WM capacity is greater for tasks that are non-routine or functionally complex. Clinical reasoning displays evidence of this task-dependent importance of individual ability. No single factor is both necessary and sufficient in explaining expertise, and individual abilities such as WM can be important. These individual abilities are likely to contribute to expert performance in clinical settings. Medical education research and practice should identify the individual differences in novices and experts that are important to clinical performance. © 2013 John Wiley & Sons Ltd.

The laboratory workforce shortage: a managerial perspective.

PubMed

Cortelyou-Ward, Kendall; Ramirez, Bernardo; Rotarius, Timothy

2011-01-01

Most clinical laboratories in the nation report severe difficulties in recruitment and retention of most types of personnel. Other important factors impacting this problem include work complexities, increased automation, and a graying workforce. As a further challenge, institutional needs for clinical laboratory personnel are expected to grow significantly in the next decade. This article examines the current situation of the clinical laboratory workforce. It analyzes the different types of personnel; the managerial, supervision, and line positions that are key for different types of laboratories; the job outlook and recent projections for different types of staff; and the current issues, trends, and challenges of the laboratory workforce. Laboratory managers need to take action with strategies suggested for overcoming these challenges. Most importantly, they need to become transformational leaders by developing effective staffing models, fostering healthy and productive work environments, and creating value with a strategic management culture and implementation of knowledge management.

Different EGFR gene mutations in two patients with synchronous multiple lung cancers: A case report

PubMed Central

Sakai, Hiroki; Kimura, Hiroyuki; Tsuda, Masataka; Wakiyama, Yoichi; Miyazawa, Tomoyuki; Marushima, Hideki; Kojima, Koji; Hoshikawa, Masahiro; Takagi, Masayuki; Nakamura, Haruhiko

2017-01-01

Routine clinical and pathological evaluations to determine the relationship between different lesions are often not completely conclusive. Interestingly, detailed genetic analysis of tumor samples may provide important additional information and identify second primary lung cancers. In the present study, we report cases of two synchronous lung adenocarcinomas composed of two distinct pathological subtypes with different EGFR gene mutations: a homozygous deletion in exon 19 of the papillary adenocarcinoma subtype and a point mutation of L858R in exon 21 of the tubular adenocarcinoma. The present report highlights the clinical importance of molecular cancer biomarkers to guide management decisions in cases involving multiple lung tumors. PMID:29090842

The challenge of detecting herds sub-clinically infected with Actinobacillus pleuropneumoniae.

PubMed

Gottschalk, Marcelo

2015-10-01

The introduction into a naïve herd of animals sub-clinically infected with Actinobacillus pleuropneumoniae (App) is frequently the cause of clinical pleuropneumonia and the identification of such infected herds is a priority in the control of disease. Different serological tests for App have been developed and a number of these are routinely used. Some are species-specific whereas others identify more specifically the serotype/serogroup involved which requires updated information about important serotypes recovered from diseased pigs in a given area/country. Serotyping methods based on molecular techniques have been developed lately and are ready to be used by most diagnostic laboratories. When non-conclusive serological results are obtained, direct detection of App from tonsils is sometimes attempted. This review addresses different techniques and approaches used to monitor herds sub-clinically infected by this important pathogen. Copyright © 2015 Elsevier Ltd. All rights reserved.

The ENDOCARE questionnaire guides European endometriosis clinics to improve the patient-centeredness of their care.

PubMed

Dancet, E A F; Apers, S; Kluivers, K B; Kremer, J A M; Sermeus, W; Devriendt, C; Nelen, W L D M; D'Hooghe, T M

2012-11-01

How patient-centered are two included specialized endometriosis clinics relative to each other and how can they improve the patient-centeredness of their care? The validated ENDOCARE questionnaire (ECQ) reliably concluded that the adjusted overall patient-centeredness did not differ between the clinics, that each clinic was significantly more patient-centered for 2 out of 10 dimensions of patient-centered endometriosis care and that clinics 1 and 2 had to improve 8 and 13 specific care aspects, respectively. Patient-centered endometriosis care is essential to high-quality care and is defined by 10 dimensions. The ECQ was developed, validated and proved to be reliable in a European setting of self-reported endometriosis patients but had not yet been used at a clinic level for quality management. A cross-sectional survey was disseminated in 2011 to all 514 women diagnosed with endometriosis during a laparoscopy indicated for pain and/or infertility during a retrospective 2-year period (2009-2010) in two university clinics from two different European countries. In total 337 patients completed the ECQ (216 and 121 per clinic). Respondents had a mean age of 34.3 years. Three in four reported a surgical diagnosis of moderate or severe endometriosis and the majority reported surgical treatment by a multidisciplinary team. The ECQ assessed the 10 dimensions of patient-centeredness, more specifically whether the health-care performance, as perceived by patients, measured up to what is important to patients in general. The ECQ was completed by 337 respondents (response rate = 65.6%). Reliability and validity of the ECQ for use on clinic level were confirmed. Clinics did not differ in overall mean importance scores; importance rankings of the ECQ dimensions were almost identical. The overall patient-centeredness scores (PCS), adjusted for education level, did not discriminate between the clinics. However, the adjusted PCS for the dimensions 'clinic staff' and 'technical skills' were significantly better in clinic 1, whereas the dimensions 'physical comfort' and 'access to care' were significantly better in clinic 2. There were 8 (clinic 1) and 13 (clinic 2) targets identified for joint and cross-clinic improvement. Response rates were relatively high. Recall bias was the most important limitation and research in more clinics is needed to define the statistical discriminative value of the ECQ. European endometriosis clinics can use the validated ECQ for reliable assessment of their 'patient-centeredness', for comparison with others and for setting specific targets to improve the patient-centeredness of their endometriosis care, to plan interventions, and to evaluate their effectiveness. This work was funded by KU Leuven and European Network of Endometriosis (ENE), supported by the European Commission (Public Health Executive Agency). No competing interests are declared.

Nursing students' assessment of the learning environment in different clinical settings.

PubMed

Bisholt, Birgitta; Ohlsson, Ulla; Engström, Agneta Kullén; Johansson, Annelie Sundler; Gustafsson, Margareta

2014-05-01

Nursing students perform their clinical practice in different types of clinical settings. The clinical learning environment is important for students to be able to achieve desired learning outcomes. Knowledge is lacking about the learning environment in different clinical settings. The aim was to compare the learning environment in different clinical settings from the perspective of the nursing students. A cross-sectional study with comparative design was conducted. Data was collected from 185 nursing students at three universities by means of a questionnaire involving the Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) evaluation scale. An open-ended question was added in order to ascertain reasons for dissatisfaction with the clinical placement. The nursing students' satisfaction with the placement did not differ between clinical settings. However, those with clinical placement in hospital departments agreed more strongly that sufficient meaningful learning situations occurred and that learning situations were multi-dimensional. Some students reported that the character of the clinical setting made it difficult to achieve the learning objectives. In the planning of the clinical placement, attention must be paid to whether the setting offers the student a meaningful learning situation where the appropriate learning outcome may be achieved. Copyright © 2013 Elsevier Ltd. All rights reserved.

The stakeholder approach: a new perspective on developing and marketing clinical trials.

PubMed

Droms, Courtney M; Ferguson, Michael; Giuliano, Karen

2014-01-01

The use of evidence-based medical practice has become the standard for health care decision-making. Thus, it has become increasingly important for medical device manufactures to provide evidence for the efficacy of their products. As new products, services, and solutions are developed, it is important to perform a stakeholder analysis to assess clinical evidence needs. As evidenced by the variety of stakeholders in clinical trials, we expect that each has different interests in how clinical trials are developed, conducted, and promoted to the general public. This analysis of the stakeholders' concerns provides recommendations for marketing professionals on meeting the needs of these stakeholders.

A Comparison of General Medical and Clinical Ethics Consultations: What Can We Learn From Each Other?

PubMed Central

Geppert, Cynthia M.A.; Shelton, Wayne N.

2012-01-01

Despite the emergence of clinical ethics consultation as a clinical service in recent years, little is known about how clinical ethics consultation differs from, or is the same as, other medical consultations. A critical assessment of the similarities and differences between these 2 types of consultations is important to help the medical community appreciate ethics consultation as a vital service in today's health care setting. Therefore, this Special Article presents a comparison of medical and clinical ethics consultations in terms of fundamental goals of consultation, roles of consultants, and methodologic approaches to consultation, concluding with reflections on important lessons about the physician-patient relationship and medical education that may benefit practicing internists. Our aim is to examine ethics consultation as a clinical service integral to the medical care of patients. Studies for this analysis were obtained through the PubMed database using the keywords ethics consultation, medical consultation, ethics consults, medical consults, ethics consultants, and medical consultants. All English-language articles published from 1970 through August 2011 that pertained to the structure and process of medical and ethics consultation were reviewed. PMID:22469350

Clinical Significance and Characteristic Clinical Differences of Cytolytic Vaginosis in Recurrent Vulvovaginitis.

PubMed

Yang, Shuhua; Zhang, Yuexiang; Liu, Ying; Wang, Jianhong; Chen, Shuqin; Li, Shuxia

2017-01-01

The study aimed to evaluate whether cytolytic vaginosis (CV) has important clinical implications for recurrent vulvovaginitis and to identify clinical differences between CV and vulvovaginal candidosis (VVC). Medical histories, physical examinations and laboratory findings were used to diagnose and assess the prevalence rates of various vulvovaginal infections among 536 women with recurrent vulvovaginitis. Chi-square and Fisher exact tests were used to compare age, menstrual cycle phase at episode onset, symptoms/signs of infection and discharge characteristics between CV and VVC with single infection. Among the 484 women with a single-infection recurrent vulvovaginitis, the prevalence of CV (n = 143; 26.7%) was second only to VVC (n = 196; 36.6%). CV symptoms occurred predominantly during the ovulatory and luteal phases. Meanwhile, VVC episodes were not concentrated premenstrually, but rather occurred throughout the menstrual cycle. Significant differences were found in the vaginal pH, discharge characteristics and frequency of inflammatory symptoms between the 2 groups. CV is clinically important, because it is a common cause of recurrent vulvovaginitis. To distinguish CV from VVC, gynecologists should consider the patient's medical history, physical and laboratory findings, vaginal pH and vaginal discharge characteristics. © 2016 S. Karger AG, Basel.

Medical Paraclinical Standards, Political Economy of Clinic, and Patients’ Clinical Dependency; A Critical Conversation Analysis of Clinical Counseling in South of Iran

PubMed Central

Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

2014-01-01

Background: Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. Methods: The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. Results: Results show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Conclusion: Although we can’t condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can’t reduce it to instrumental and linear methods of body treatment. PMID:25349858

Linking the Tinnitus Questionnaire and the subjective Clinical Global Impression: Which differences are clinically important?

PubMed Central

2012-01-01

Background Development of new tinnitus treatments requires prospective placebo-controlled randomized trials to prove their efficacy. The Tinnitus Questionnaire (TQ) is a validated and commonly used instrument for assessment of tinnitus severity and has been used in many clinical studies. Defining the Minimal Clinically Important Difference (MCID) for TQ changes is an important step to a better interpretation of the clinical relevance of changes observed in clinical trials. In this study we aimed to estimate the minimum change of the TQ score that could be considered clinically relevant. Methods 757 patients with chronic tinnitus were pooled from the TRI database and the RESET study. An anchor-based approach using the Clinical Global Impression (CGI) scale and distributional approaches were used to estimate MCID. Receiver Operating Characteristic (ROC) curves were calculated to define optimal TQ change cutoffs discriminating between minimally changed and unchanged subjects. Results The relationship between TQ change scores and CGI ratings of change was good (r = 0.52, p < 0.05). Mean change scores associated with minimally better and minimally worse CGI categories were −6.65 and +2.72 respectively. According to the ROC method MCID for improvement was −5 points and for deterioration +1 points. Conclusion Distribution and anchor-based methods yielded comparable results in identifying MCIDs. ΔTQ scores of −5 and +1 points were identified as the minimal clinically relevant change for improvement and worsening respectively. The asymmetry of the MCIDs for improvement and worsening may be related to expectation effects. PMID:22781703

Co-occurrence of m.1555A>G and m.11778G>A mitochondrial DNA mutations in two Indian families with strikingly different clinical penetrance of Leber hereditary optic neuropathy

PubMed Central

Khan, Nahid Akhtar; Govindaraj, Periyasamy; Jyothi, Vuskamalla; Meena, Angamuthu K

2013-01-01

Background Mitochondrial DNA (mtDNA) mutations are known to cause Leber hereditary optic neuropathy (LHON). However, the co-occurrence of double pathogenic mutations with different pathological significance in pedigrees is a rare event. Methods Detailed clinical investigation and complete mtDNA sequencing analysis was performed for two Indian families with LHON. The haplogroup was constructed based on evolutionarily important mtDNA variants. Results We observed the existence of double pathogenic mutations (m.11778G>A and m.1555A>G) in two Indian LHON families, who are from different haplogroup backgrounds (M5a and U2e1), with different clinical penetrance of the disease (visual impairment). The m.11778G>A mutation in the MT-ND4 gene is associated primarily with LHON; whereas, m.1555A>G in the 12S rRNA gene has been reported with aminoglycoside-induced non-syndromic hearing loss. Conclusions The absence of hearing abnormality and widely varying clinical expression of LHON suggest additional nuclear modifier genes, environmental factors, and population heterogeneity might play an important role in the expression of visual impairment in these families. PMID:23805034

Clinical Applications of Resting State Functional Connectivity

PubMed Central

Fox, Michael D.; Greicius, Michael

2010-01-01

During resting conditions the brain remains functionally and metabolically active. One manifestation of this activity that has become an important research tool is spontaneous fluctuations in the blood oxygen level-dependent (BOLD) signal of functional magnetic resonance imaging (fMRI). The identification of correlation patterns in these spontaneous fluctuations has been termed resting state functional connectivity (fcMRI) and has the potential to greatly increase the translation of fMRI into clinical care. In this article we review the advantages of the resting state signal for clinical applications including detailed discussion of signal to noise considerations. We include guidelines for performing resting state research on clinical populations, outline the different areas for clinical application, and identify important barriers to be addressed to facilitate the translation of resting state fcMRI into the clinical realm. PMID:20592951

What Does It Take to Change an Editor's Mind? Identifying Minimally Important Difference Thresholds for Peer Reviewer Rating Scores of Scientific Articles.

PubMed

Callaham, Michael; John, Leslie K

2018-01-05

We define a minimally important difference for the Likert-type scores frequently used in scientific peer review (similar to existing minimally important differences for scores in clinical medicine). The magnitude of score change required to change editorial decisions has not been studied, to our knowledge. Experienced editors at a journal in the top 6% by impact factor were asked how large a change of rating in "overall desirability for publication" was required to trigger a change in their initial decision on an article. Minimally important differences were assessed twice for each editor: once assessing the rating change required to shift the editor away from an initial decision to accept, and the other assessing the magnitude required to shift away from an initial rejection decision. Forty-one editors completed the survey (89% response rate). In the acceptance frame, the median minimally important difference was 0.4 points on a scale of 1 to 5. Editors required a greater rating change to shift from an initial rejection decision; in the rejection frame, the median minimally important difference was 1.2 points. Within each frame, there was considerable heterogeneity: in the acceptance frame, 38% of editors did not change their decision within the maximum available range; in the rejection frame, 51% did not. To our knowledge, this is the first study to determine the minimally important difference for Likert-type ratings of research article quality, or in fact any nonclinical scientific assessment variable. Our findings may be useful for future research assessing whether changes to the peer review process produce clinically meaningful differences in editorial decisionmaking. Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Quality management and work environment in Swedish oral and maxillofacial surgery.

PubMed

Pilgård, Göran

2009-01-01

This thesis attempts to describe the opinion of the work with quality, quality management, and work environment among the employees at Oral and Maxillofacial Surgery (OMFS) clinics in Sweden. Analyse if the OMFS clinics in Sweden actively work with quality development and if so which systems they use. Explore the opinion of the employees about quality work. Describe how the employees of OMFS clinics in Sweden perceive good work, i.e., their image of the dimensions that the profession should contain to be really good work. Investigate whether there is a discrepancy between ideal and reality for this group. Describe how the employees of OMFS clinics in Sweden perceive their health. Analyse how work environment influenced attitudes to and knowledge of quality among employees of OMFS clinics in Sweden. The study was based on self-report questionnaires which in 2003 were sent to all OMFS clinics in Sweden. The response rate was 86%. Only at two clinics did all the respondents agree on their system. Surgeons rated intellectually stimulating work as most important, and the hazard-free work environment as least important. The nurses rated stimulating fellowship as most important, and the opportunity for career advancement as least important. The percentage unit differences between the ideal and the reality were largest for the item the work provides opportunities to have an influence on important decisions. There were significant differences between maxillofacial. surgeons and dental nurses and assistant nurses as to muscle- and joint trouble. The differences were also significant between men and women both as to muscle- and joint troubles and somatic trouble. Only work environment was significant for attitude towards quality work. Profession, gender, clinic size, and a factor for hard demand had significant associations to quality management system used or not. More than half of the respondents stated that they worked with a quality system. The dental nurses and assistant nurses had a much more positive view on the potential of quality work as a means to improve their work than had the maxillo-facial surgeons. For a majority of the dental nurses the working situation concerning the physical environment was more important than for the maxillo-facial surgeons. The employees emphasized free, influential, and intellectually stimulating work, but the dissonance between ideal and reality was rather wide concerning good work. OMFS employees are feeling unhealthy, but no worse than other high-risk-groups in human service working and better than female general practice dentists. The women of OMFS employees feel worse than the men.

Importance of population-based studies in clinical practice

PubMed Central

Ronnie, George; Ve, Ramesh Sathyamangalam; Velumuri, Lokapavani; Asokan, Rashima; Vijaya, Lingam

2011-01-01

In the last decade, there have been reports on the prevalence of glaucoma from the Vellore Eye Survey, Andhra Pradesh Eye Diseases Survey, Aravind Comprehensive Eye Survey, Chennai Glaucoma Study and West Bengal Glaucoma Study. Population-based studies provide important information regarding the prevalence and risk factors for glaucoma. They also highlight regional differences in the prevalence of various types of glaucoma. It is possible to gather important insights regarding the number of persons affected with glaucoma and the proportion with undiagnosed disease. We reviewed the different population-based studies from India and compare their findings. The lacunae in ophthalmic care that can be inferred from these studies are identified and possible reasons and solutions are discussed. We also discuss the clinical relevance of the various findings, and how it reflects on clinical practice in the country. Since India has a significantly high disease burden, we examine the possibility of population-based screening for disease in the Indian context. PMID:21150021

Clinical trials of a personal electrocardiograph

NASA Astrophysics Data System (ADS)

Boyakhchyan, A.; Lezhnina, I.; Overchuk, K.; Perchatkin, V.; Lvova, A.; Alexander, U.

2018-05-01

The article describes the results of a clinical trial at the Cardiology Research Institute in Tomsk. Clinical trials were conducted to identify different important information for diagnosis. These tests were also conducted to remotely monitor the treatment of patients who had already been discharged from the hospital.The study involved 15 patients, the most interesting cases are described in this article.

Examining Curricular Integration Strategies To Optimize Learning Of The Anatomical Sciences

NASA Astrophysics Data System (ADS)

Lisk, Kristina Adriana Ayako

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

Responsiveness of the VISA-P scale for patellar tendinopathy in athletes.

PubMed

Hernandez-Sanchez, Sergio; Hidalgo, Ma Dolores; Gomez, Antonia

2014-03-01

Patient-reported outcome measures are increasingly used in sports medicine to assess results after treatment, but interpretability of change for many instruments remains unclear. To define the minimum clinically important difference (MCID) for the Victorian Institute of Sport Assessment scale (VISA-P) in athletes with patellar tendinopathy (PT) who underwent conservative treatment. Ninety-eight athletes with PT were enrolled in the study. Each participant completed the VISA-P at admission, after 1 week, and at the final visit. Athletes also assessed their clinical change at discharge on a 15-point Likert scale. We equated important change with a score of ≥3 (somewhat better). Receiver-operating characteristic (ROC) curve analysis and mean change score were used to determine MCID. Minimal detectable change was calculated. The effect of baseline scores on MCID and different criteria used to define important change were investigated. A Bayesian analysis was used to establish the posterior probability of reporting clinical changes related to MCID value. Athletes with PT who showed an absolute change greater than 13 points in the VISA-P score or 15.4-27% of relative change achieved a minimal important change in their clinical status. This value depended on baseline scores. The probability of a clinical change in a patient was 98% when this threshold was achieved and 45% when MCID was not achieved. Definition of the MCID will enhance the interpretability of changes in the VISA-P score in the athletes with PT, but caution is required when these values are used.

Important aspects of participation and participation restrictions in people with a mild intellectual disability.

PubMed

Arvidsson, Patrik; Granlund, Mats; Thyberg, Ingrid; Thyberg, Mikael

2014-01-01

This study explored a possibility to assess the concepts of participation and participation restrictions in the International Classification of Functioning, Disability and Health (ICF) by combining self-ratings of the perceived importance with the actual performance of different everyday activities in people with a mild intellectual disability. Structured interviews regarding 68 items from the ICF activity/participation domain were conducted (n = 69). The items were ranked by perceived importance, performance and by combined measures. Furthermore, the measures were related to a single question about subjective general well-being. Rankings of performance highlighted about the same items as "important participation", while rankings of low performance addressed quite different items compared with "important participation restriction". Significant correlations were found between subjective general well-being and high performance (r = 0.56), high performance/high importance (important participation) (r = 0.56), low performance (r = -0.56) and low performance/high importance (important participation restriction; r = -0.55). The results support the clinical relevance of the ICF and the studied selection of 68 items. Although performance only may sometimes be a relevant aspect, knowledge about the relationship between the perceived importance and the actual performance is essential for clinical interventions and for research aiming to understand specific needs regarding participation. The concepts of participation and participation restriction are highly relevant in people with a mild intellectual disability. Self-rated performance might be sufficient to assess participation at a group level. In clinical practices, the relationship between the perceived importance and the actual performance of an activity is essential to assess.

[Gastritis and gastropathy].

PubMed

Mihály, Emese; Micsik, Tamás; Juhász, Márk; Herszényi, László; Tulassay, Zsolt

2014-01-12

Alterations of the stomach mucosa in response to different adverse effects result in various morphological and clinical symptoms. Gastric mucosa alterations can be classified on the bases of diverse viewpoints. It makes this overview difficult, that identical toxic effects may cause different mucosal changes and different toxic agents may produce similar mucosal appearance. The more accurate understanding of the pathological processes which develop in the stomach mucosa needs reconsideration. The authors make an attempt to define gastritis and gastropathy in order to classify and present their features. Gastritis is a histological definition indicating mucosal inflammation. Acute gastritis is caused by infections. The two most important forms of chronic gastritis are metaplastic atrophic gastritis with an autoimmune origin and Helicobacter pylori inflammation. Gastropathy is the name of different structural alterations of the mucosa. Its most important feature is the paucity of inflammatory signs. Gastropathies can be divided into 4 categories based on the nature of the underlying pathological effect, on its morphological appearance and the way of the development. Differential diagnosis is an important pathological and clinical task because different treatment methods and prognosis.

What is the effect of surgery on the quality of life of the adolescent with adolescent idiopathic scoliosis? A review and statistical analysis of the literature.

PubMed

Rushton, Paul R P; Grevitt, Michael P

2013-04-20

Review and statistical analysis of studies evaluating the effect of surgery on the health-related quality of life of adolescents with adolescent idiopathic scoliosis, using Scoliosis Research Society (SRS) outcomes. Apply published minimum clinical important differences (MCID) values for the SRS22r questionnaire to the literature to identify what areas of health-related quality of life are consistently affected by surgery and whether changes are clinically meaningful. The interpretation of published studies using the SRS outcomes has been limited by the lack of MCID values for the questionnaire domains. The recent publication of these data allows the clinical importance of any changes in these studies to be examined for the first time. A literature search was undertaken to locate suitable studies that were then analyzed. Statistically significant differences from baseline to 2 years postoperatively were ascertained by narratively reporting the analyses within included studies. When possible, clinically significant changes were assessed using 95% confidence intervals for the change in mean domain score. If the lower bound of the confidence intervals for the change exceeded the MCID for that domain, the change was considered clinically significant. The numbers of cohorts available for the different analyses varied (5-16). Eighty-one percent and 94% of included cohorts experienced statistically significant improvements in pain and self-image domains. In terms of clinical significance, it was only self-image that regularly improved by more than MCID, doing so in 4 of 5 included cohorts (80%) compared with 1 of 12 cohorts (8%) for pain. No clinically relevant changes occurred in mental health or activity domains. Evidence suggests that surgery can lead to clinically important improvement in patient self-image. Surgeons and patients should be aware of the limited evidence for improvements in domains other than self-image after surgery. Surgical decision-making will also be influenced by the natural history of adolescent idiopathic scoliosis.

Occurrence and Diversity of Clinically Important Vibrio Species in the Aquatic Environment of Georgia

PubMed Central

Kokashvili, Tamar; Whitehouse, Chris A.; Tskhvediani, Ana; Grim, Christopher J.; Elbakidze, Tinatin; Mitaishvili, Nino; Janelidze, Nino; Jaiani, Ekaterine; Haley, Bradd J.; Lashkhi, Nino; Huq, Anwar; Colwell, Rita R.; Tediashvili, Marina

2015-01-01

Among the more than 70 different Vibrio species inhabiting marine, estuarine, and freshwater ecosystems, 12 are recognized as human pathogens. The warm subtropical climate of the Black Sea coastal area and inland regions of Georgia likely provides a favorable environment for various Vibrio species. From 2006 to 2009, the abundance, ecology, and diversity of clinically important Vibrio species were studied in different locations in Georgia and across seasons. Over a 33-month period, 1,595 presumptive Vibrio isolates were collected from the Black Sea (n = 657) and freshwater lakes around Tbilisi (n = 938). Screening of a subset of 440 concentrated and enriched water samples by PCR-electrospray ionization/mass spectrometry (PCR-ESI/MS) detected the presence of DNA from eight clinically important Vibrio species: V. cholerae, V. parahaemolyticus, V. vulnificus, V. mimicus, V. alginolyticus, V. harveyi, V. metschnikovii, and V. cincinnatiensis. Almost 90% of PCR/ESI-MS samples positive for Vibrio species were collected from June through November. Three important human-pathogenic Vibrio species (V. cholerae, V. parahaemolyticus, and V. vulnificus) were detected in 62.8, 37.8, and 21.4% of samples testing positive for Vibrios, respectively. The results of these activities suggest that natural reservoirs for human-pathogenic Vibrios exist in Georgian aquatic environments. Water temperature at all sampling sites was positively correlated with the abundance of clinically important Vibrio spp. (except V. metschnikovii), and salinity was correlated with species composition at particular Black Sea sites as well as inland reservoirs. PMID:26528464

Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers.

PubMed

Goldstein, Judith E; Jackson, Mary Lou; Fox, Sandra M; Deremeik, James T; Massof, Robert W

2015-07-01

To facilitate comparative clinical outcome research in low vision rehabilitation, we must use patient-centered measurements that reflect clinically meaningful changes in visual ability. To quantify the effects of currently provided low vision rehabilitation (LVR) on patients who present for outpatient LVR services in the United States. Prospective, observational study of new patients seeking outpatient LVR services. From April 2008 through May 2011, 779 patients from 28 clinical centers in the United States were enrolled in the Low Vision Rehabilitation Outcomes Study. The Activity Inventory, a visual function questionnaire, was administered to measure overall visual ability and visual ability in 4 functional domains (reading, mobility, visual motor function, and visual information processing) at baseline and 6 to 9 months after usual LVR care. The Geriatric Depression Scale, Telephone Interview for Cognitive Status, and Medical Outcomes Study 36-Item Short-Form Health Survey physical functioning questionnaires were also administered to measure patients' psychological, cognitive, and physical health states, respectively, and clinical findings of patients were provided by study centers. Mean changes in the study population and minimum clinically important differences in the individual in overall visual ability and in visual ability in 4 functional domains as measured by the Activity Inventory. Baseline and post-rehabilitation measures were obtained for 468 patients. Minimum clinically important differences (95% CIs) were observed in nearly half (47% [95% CI, 44%-50%]) of patients in overall visual ability. The prevalence rates of patients with minimum clinically important differences in visual ability in functional domains were reading (44% [95% CI, 42%-48%]), visual motor function (38% [95% CI, 36%-42%]), visual information processing (33% [95% CI, 31%-37%]), and mobility (27% [95% CI, 25%-31%]). The largest average effect size (Cohen d = 0.87) for the population was observed in overall visual ability. Age (P = .006) was an independent predictor of changes in overall visual ability, and logMAR visual acuity (P = .002) was predictive of changes in visual information processing. Forty-four to fifty percent of patients presenting for outpatient LVR show clinically meaningful differences in overall visual ability after LVR, and the average effect sizes in overall visual ability are large, close to 1 SD.

THE 6-MINUTE WALK TEST AND OTHER CLINICAL ENDPOINTS IN DUCHENNE MUSCULAR DYSTROPHY: RELIABILITY, CONCURRENT VALIDITY, AND MINIMAL CLINICALLY IMPORTANT DIFFERENCES FROM A MULTICENTER STUDY

PubMed Central

McDonald, Craig M; Henricson, Erik K; Abresch, R Ted; Florence, Julaine; Eagle, Michelle; Gappmaier, Eduard; Glanzman, Allan M; Spiegel, Robert; Barth, Jay; Elfring, Gary; Reha, Allen; Peltz, Stuart W

2013-01-01

Introduction: An international clinical trial enrolled 174 ambulatory males ≥5 years old with nonsense mutation Duchenne muscular dystrophy (nmDMD). Pretreatment data provide insight into reliability, concurrent validity, and minimal clinically important differences (MCIDs) of the 6-minute walk test (6MWT) and other endpoints. Methods: Screening and baseline evaluations included the 6-minute walk distance (6MWD), timed function tests (TFTs), quantitative strength by myometry, the PedsQL, heart rate–determined energy expenditure index, and other exploratory endpoints. Results: The 6MWT proved feasible and reliable in a multicenter context. Concurrent validity with other endpoints was excellent. The MCID for 6MWD was 28.5 and 31.7 meters based on 2 statistical distribution methods. Conclusions: The ratio of MCID to baseline mean is lower for 6MWD than for other endpoints. The 6MWD is an optimal primary endpoint for Duchenne muscular dystrophy (DMD) clinical trials that are focused therapeutically on preservation of ambulation and slowing of disease progression. Muscle Nerve 48: 357–368, 2013 PMID:23674289

Psychological stress in sarcoidosis.

PubMed

Wilsher, Margaret L

2012-09-01

Sarcoidosis is a chronic illness associated with emotional and physical consequences which impact on quality of life. Although the impact of fatigue is well understood, emotional impacts of sarcoidosis are less commonly recognized and addressed in routine clinical practice. The purpose of this review is to highlight that sarcoidosis can result in considerable psychological distress. Not only is there a high prevalence of depressive symptoms in sarcoidosis, but clinical depressive and anxiety disorders are more common than seen in the general population. Patients with sarcoidosis have perceptions and beliefs about their disease that may impact on their willingness to engage in recommended therapies. They may also exhibit a disordered perception of their disease and a personality profile of neuroticism. Understanding the minimally important clinical difference in the Fatigue Assessment Scale (FAS) and validation of the Sarcoidosis Health Questionnaire (SHQ) across different populations supports the use of these tools in routine clinical practice and clinical trials. Understanding the global impact of sarcoidosis is important for patients and clinicians, and use of validated instruments, such as the SHQ and FAS, allows for more comprehensive assessment of the disease and the impact of any interventions.

Differences in the API 20E biochemical patterns of clinical and environmental Vibrio parahaemolyticus isolates.

PubMed

Martinez-Urtaza, Jaime; Lozano-Leon, Antonio; Viña-Feas, Alejandro; de Novoa, Jacobo; Garcia-Martin, Oscar

2006-02-01

Genetic differences in clinical and environmental strains of Vibrio parahaemolyticus have been widely used as criteria in identifying pathogenic isolates. However, few studies have been carried out to assess the differences in biochemical characteristics of V. parahaemolyticus isolates from human and environmental sources. We compared the biochemical profiles obtained by the characterization of V. parahaemolyticus isolates from human infections and the marine environment using the API 20E system. Environmental and clinical isolates showed significant differences in the gelatin and arabinose tests. Additionally, clinical isolates were correctly identified according to the API 20E profile using 0.85% NaCl diluent, but they presented nonspecific profiles with 2% NaCl diluent. In contrast, use of 2% NaCl diluent facilitated correct identification of the environmental isolates. Clinical isolates showed significant differences in up to five biochemical tests with respect to the API 20E database. The API 20E system is widely used in routine identification of bacteria in clinical laboratories, and this discrepancy in an important number of biochemical tests may lead to misidentification of V. parahaemolyticus infection.

What's so different about Lacan's approach to psychoanalysis?

PubMed

Fink, Bruce

2011-12-01

Clinical work based on Lacanian principles is rarely compared in the psychoanalytic literature with that based on other principles. The author attempts to highlight a few important theoretical differences regarding language, desire, affect, and time between a Lacanian approach and certain others that lead to differences in focus and technique, related, for example, to interpretation, scansion, and countertransference. Lacanian techniques are illustrated with brief clinical vignettes. In the interest of confidentiality, identifying information and certain circumstances have been changed or omitted in the material presented.

A simple versatile solution for collecting multidimensional clinical data based on the CakePHP web application framework.

PubMed

Biermann, Martin

2014-04-01

Clinical trials aiming for regulatory approval of a therapeutic agent must be conducted according to Good Clinical Practice (GCP). Clinical Data Management Systems (CDMS) are specialized software solutions geared toward GCP-trials. They are however less suited for data management in small non-GCP research projects. For use in researcher-initiated non-GCP studies, we developed a client-server database application based on the public domain CakePHP framework. The underlying MySQL database uses a simple data model based on only five data tables. The graphical user interface can be run in any web browser inside the hospital network. Data are validated upon entry. Data contained in external database systems can be imported interactively. Data are automatically anonymized on import, and the key lists identifying the subjects being logged to a restricted part of the database. Data analysis is performed by separate statistics and analysis software connecting to the database via a generic Open Database Connectivity (ODBC) interface. Since its first pilot implementation in 2011, the solution has been applied to seven different clinical research projects covering different clinical problems in different organ systems such as cancer of the thyroid and the prostate glands. This paper shows how the adoption of a generic web application framework is a feasible, flexible, low-cost, and user-friendly way of managing multidimensional research data in researcher-initiated non-GCP clinical projects. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Minimal Clinically Important Difference of Berg Balance Scale in People With Multiple Sclerosis.

PubMed

Gervasoni, Elisa; Jonsdottir, Johanna; Montesano, Angelo; Cattaneo, Davide

2017-02-01

To identify the minimal clinically important difference (MCID) to define clinically meaningful patient's improvement on the Berg Balance Scale (BBS) in people with multiple sclerosis (PwMS) in response to rehabilitation. Cohort study. Neurorehabilitation institute. PwMS (N=110). This study comprised inpatients and outpatients who participated in research on balance and gait rehabilitation. All received 20 rehabilitation sessions with different intensities. Inpatients received daily treatments over a period of 4 weeks, while outpatients received 2 to 3 treatments per week for 10 weeks. An anchor-based approach using clinical global impression of improvement in balance (Activities-specific Balance Confidence [ABC] Scale) was used to determine the MCID of the BBS. The MCID was defined as the minimum change in the BBS total score (postintervention - preintervention) that was needed to perceive at least a 10% improvement on the ABC Scale. Receiver operating characteristic curves were used to define the cutoff of the optimal MCID of the BBS discriminating between improved and not improved subjects. The MCID for change on the BBS was 3 points for the whole sample, 3 points for the inpatients, and 2 points for the outpatients. The area under the curve was .65 for the whole sample, .64 for inpatients, and .68 for outpatients. The MCID for improvement in balance as measured by the BBS was 3 points, meaning that PwMS are likely to perceive that as a reproducible and clinically important change in their balance performance. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Skin marker placement by technologist prior to knee MRI helps identify clinically relevant pathologies.

PubMed

Wadhwa, Vibhor; Weissman, Eric; Hayashi, Daichi; Xi, Yin; Chhabra, Avneesh

2017-12-15

Majority of musculoskeletal cross-sectional imaging requests have a non-revealing and non-specific clinical history of pain. However, the location of pain is very relevant towards arriving at a specific orthopedic diagnosis. The purpose of this research was to study the impact of skin marker placement and training of technologists prior to knee MRI in detection of clinically important findings. Total 200 consecutive left knee MRIs were evaluated before and after technologist training with regards to marker placement at the site of clinical symptoms or palpable finding. Marker location in relation to the knee was recorded and important findings were classified as correlated important finding, non-correlated important finding, other compartment important finding in non-correlated cases, and diffuse abnormality, i.e. tri-compartmental cartilage defects in both correlated and non-correlated cases. Differences among scans before and after technologist training were analyzed. The marker placement was observed in higher proportion of patients in post-training scans (78% vs 60%, p = 0.00). The most common location of the marker was in anterior or anterolateral knee (32% and 34% cases, respectively). The marker-important finding correlation was also higher post training, but not statistically significant (53% versus 38%, p = 0.57). Important findings correlated with the marker in more than 50% of the scans in the post-training set. Marker placement can aid in detection of clinically important imaging finding and technologist training aids in increased rates of marker placement and improved correlation.

Evaluating linguistic equivalence of patient-reported outcomes in a cancer clinical trial.

PubMed

Hahn, Elizabeth A; Bode, Rita K; Du, Hongyan; Cella, David

2006-01-01

In order to make meaningful cross-cultural or cross-linguistic comparisons of health-related quality of life (HRQL) or to pool international research data, it is essential to create unbiased measures that can detect clinically important differences. When HRQL scores differ between cultural/linguistic groups, it is important to determine whether this reflects real group differences, or is the result of systematic measurement variability. To investigate the linguistic measurement equivalence of a cancer-specific HRQL questionnaire, and to conduct a sensitivity analysis of treatment differences in HRQL in a clinical trial. Patients with newly diagnosed chronic myelogenous leukemia (n = 1049) completed serial HRQL assessments in an international Phase III trial. Two types of differential item functioning (uniform and non-uniform) were evaluated using item response theory and classical test theory approaches. A sensitivity analysis was conducted to compare HRQL between treatment arms using items without evidence of differential functioning. Among 27 items, nine (33%) did not exhibit any evidence of differential functioning in both linguistic comparisons (English versus French, English versus German). Although 18 items functioned differently, there was no evidence of systematic bias. In a sensitivity analysis, adjustment for differential functioning affected the magnitude, but not the direction or interpretation of clinical trial treatment arm differences. Sufficient sample sizes were available for only three of the eight language groups. Identification of differential functioning in two-thirds of the items suggests that current psychometric methods may be too sensitive. Enhanced methodologies are needed to differentiate trivial from substantive differential item functioning. Systematic variability in HRQL across different groups can be evaluated for its effect upon clinical trial results; a practice recommended when data are pooled across cultural or linguistic groups to make conclusions about treatment effects.

Mental and somatic health in a non-clinical sample 10 years after a diagnosis of encopresis.

PubMed

Hultén, Ib; Jonsson, Jakob; Jonsson, Carl-Otto

2005-12-01

The aim of this study was to assess the relation between the diagnosis of encopresis at 8 and 10 years of age, and mental and somatic health 10 years later. The importance of type of encopresis (primary or secondary) at 8 years was also studied. Subjects were a non-clinical encopretic sample (N=73) and control subjects (N=75) [2]. Seven assessment variables from conscription surveys provided information about mental and somatic health status at 18 years of age. Former encopretics (n=66) did not differ significantly from the controls (n=67) at 18 years of age, although there were consistent, small negative differences. The boys who at 10 years of age had still been encopretic did not differ significantly at 18 years of age from the boys who at 10 years had recovered from encopresis, and the signs indicating the small differences varied. For former primary and secondary encopretic boys, there were two significant differences, the men in the secondary group being more often exempted from conscription than the primary group and the control cases. The results indicate that boys with non-clinical encopresis show only small, if any, mental and somatic disturbances at the beginning of adulthood. Comprehensive investigations of encopretic patients are recommended as important clinical problems, in addition to encopresis, might be present.

Myeloid derived suppressor cells in cancer: therapeutic, predictive, and prognostic implications

PubMed Central

Diaz-Montero, C. Marcela; Finke, Jim; Montero, Alberto J.

2014-01-01

Immune evasion is a hallmark of cancer. While, there are multiple different mechanisms that cancer cells employ, myeloid deriver suppressor cells (MDSCs) are one of the key drivers of tumor mediated immune evasion. MDSCs begin as myeloid cells recruited to the tumor microenvironment where they are transformed into potent immunosuppressive cells. Our understanding of the clinical relevance of MDSCs in cancer patients, however has significantly lagged behind the preclinical literature in part due to the absence of a cognate molecule present in mice, as well as the considerable heterogeneity of MDSCs. However, if one evaluates the clinical literature through the filter of clinically robust endpoints, such as overall survival, three important phenotypes have emerged: promyelocytic, monocytic, and granulocytic. Based on these studies, MDSCs have clear prognostic importance in multiple solid tumors, and emerging data supports the utility of circulating MDSCs as a predictive marker for cancer immunotherapy, and even as an early leading marker for predicting clinical response to systemic chemotherapy in patients with advanced solid tumors. More recent preclinical data in immunosuppressed murine models suggest that MDSCs play an important role in tumor progression and the metastatic process that is independent of their immunosuppressive properties. Consequently, targeting MDSCs either in combination with cancer immunotherapy or independently as part of an approach to inhibit the metastatic process, appears to be a very clinically promising strategy. We review different approaches to target MDSCs that could potentially be tested in future clinical trials in cancer patients. PMID:24787291

Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target.

PubMed

Hens, Koen; Berth, Mario; Armbruster, Dave; Westgard, Sten

2014-07-01

Six Sigma metrics were used to assess the analytical quality of automated clinical chemistry and immunoassay tests in a large Belgian clinical laboratory and to explore the importance of the source used for estimation of the allowable total error. Clinical laboratories are continually challenged to maintain analytical quality. However, it is difficult to measure assay quality objectively and quantitatively. The Sigma metric is a single number that estimates quality based on the traditional parameters used in the clinical laboratory: allowable total error (TEa), precision and bias. In this study, Sigma metrics were calculated for 41 clinical chemistry assays for serum and urine on five ARCHITECT c16000 chemistry analyzers. Controls at two analyte concentrations were tested and Sigma metrics were calculated using three different TEa targets (Ricos biological variability, CLIA, and RiliBÄK). Sigma metrics varied with analyte concentration, the TEa target, and between/among analyzers. Sigma values identified those assays that are analytically robust and require minimal quality control rules and those that exhibit more variability and require more complex rules. The analyzer to analyzer variability was assessed on the basis of Sigma metrics. Six Sigma is a more efficient way to control quality, but the lack of TEa targets for many analytes and the sometimes inconsistent TEa targets from different sources are important variables for the interpretation and the application of Sigma metrics in a routine clinical laboratory. Sigma metrics are a valuable means of comparing the analytical quality of two or more analyzers to ensure the comparability of patient test results.

Correlation between the reason for referral, clinical, and objective assessment of the risk for dysphagia.

PubMed

Mancopes, Renata; Gonçalves, Bruna Franciele da Trindade; Costa, Cintia Conceição; Favero, Talita Cristina; Drozdz, Daniela Rejane Constantino; Bilheri, Diego Fernando Dorneles; Schumacher, Stéfani Fernanda

2014-01-01

To correlate the reason for referral to speech therapy service at a university hospital with the results of clinical and objective assessment of risk for dysphagia. This is a cross-sectional, observational, retrospective analytical and quantitative study. The data were gathered from the database, and the information used was the reason for referral to speech therapy service, results of clinical assessment of the risk for dysphagia, and also from swallowing videofluoroscopy. There was a mean difference between the variables of the reason for the referral, results of the clinical and objective swallowing assessments, and scale of penetration/aspiration, although the values were not statistically significant. Statistically significant correlation was observed between clinical and objective assessments and the penetration scale, with the largest occurring between the results of objective assessment and penetration scale. There was a correlation between clinical and objective assessments of swallowing and mean difference between the variables of the reason for the referral with their respective assessment. This shows the importance of the association between the data of patient's history and results of clinical evaluation and complementary tests, such as videofluoroscopy, for correct identification of the swallowing disorders, being important to combine the use of severity scales of penetration/aspiration for diagnosis.

Clinical and Economic Implications of AF Related Stroke.

PubMed

Ali, Ali N; Abdelhafiz, Ahmed

2016-01-01

A major cause of morbidity and mortality among patients with atrial fibrillation (AF) relates to the increased risk of stroke. The burden of illness that AF imparts on stroke is likely to increase with our aging populations and increasingly sophisticated cardiac monitoring techniques. Understanding the clinical and economic differences between AF related ischaemic stroke and non-AF related stroke is important if we are to improve future cost effectiveness analyses of potential preventative treatments, but also to help educate clinical and policy decision makers on use or availability of treatments to prevent AF related stroke. In this article we review the existing evidence that highlights differences in the clinical characteristics and outcomes between AF and non-AF stroke, as well as differences in their economic impact and discuss ways to improve future economic analyses.

Clinical review: Ethnic differences in bone mass--clinical implications.

PubMed

Leslie, William D

2012-12-01

Differences in bone mineral density (BMD) as assessed with dual-energy x-ray absorptiometry are observed between geographic and ethnic groups, with important implications in clinical practice. PubMed was employed to identify relevant studies. A review of the literature was conducted, and data were summarized and integrated. The available data highlight the complex ethnic variations in BMD, which only partially account for observed variations in fracture rates. Factors contributing to ethnic differences include genetics, skeletal size, body size and composition, lifestyle, and social determinants. Despite BMD differences, the gradient of risk for fracture from BMD and other clinical risk factors appears to be similar across ethnic groups. Furthermore, BMD variation is greater within an ethnic population than between ethnic populations. New imaging technologies have identified ethnic differences in bone geometry, volumetric density, microarchitecture, and estimated bone strength that may contribute to a better understanding of ethnic differences in fracture risk. Factors associated with ethnicity affect BMD and fracture risk through direct and indirect mechanisms.

The importance of semen analysis in the context of azoospermia.

PubMed

Aziz, Nabil

2013-01-01

Azoospermia is a descriptive term referring to ejaculates that lack spermatozoa without implying a specific underlying cause. The traditional definition of azoospermia is ambiguous, which has ramifications on the diagnostic criteria. This issue is further compounded by the apparent overlap between the definitions of oligospermia and azoospermia. The reliable diagnosis of the absence of spermatozoa in a semen sample is an important criterion not only for diagnosing male infertility but also for ascertaining the success of a vasectomy and for determining the efficacy of hormonal contraception. There appears to be different levels of rigor in diagnosing azoospermia in different clinical situations, which highlights the conflict between scientific research and clinical practice in defining azoospermia.

Cosmetic outcomes of facial lacerations repaired with tissue-adhesive, absorbable, and nonabsorbable sutures.

PubMed

Holger, Joel S; Wandersee, Steve C; Hale, David B

2004-07-01

The objective of this study was to compare the 9- to 12-month cosmetic outcome of facial lacerations closed with rapid-absorbing gut suture (RG), octylcyanoacrylate (OC), or nylon suture (NL). We hypothesized that no important differences would exist between these methods. This prospective, randomized study enrolled consecutive patients with facial lacerations when experienced physician assistants were on duty for wound closure. Patients returned at 9 to 12 months for cosmetic evaluation. Two blinded physicians performed visual analog cosmesis scale (VACS) scoring, and the patient completed a VAS satisfaction score. One hundred forty-five patients were enrolled. Nine-month follow up occurred in 84 patients. The maximum difference within each evaluator's set of scores was 3.6 mm, well below the minimum clinically important difference (MCID) of 10 to 15 mm. We did not detect clinically important differences in cosmetic outcome at 9 to 12 months in patients with facial lacerations closed with RG, OC, or NL, although RG or OC could be preferred to eliminate follow-up visits for suture removal.

The heart and potassium: a banana republic.

PubMed

Khan, Ehsan; Spiers, Christine; Khan, Maria

2013-03-01

The importance of potassium in maintaining stable cardiac function is a clinically understood phenomenon. Physiologically the importance of potassium in cardiac function is described by the large number of different kinds of potassium ions channels found in the heart compared to channels and membrane transport mechanisms for other ions such as sodium and calcium. Potassium is important in physiological homeostatic control of cardiac function, but is also of relevance to the diseased state, as potassium-related effects may stabilize or destabilize cardiac function. This article aims to provide a detailed understanding of potassium-mediated cardiac function. This will help the clinical practitioner evaluate how modulation of potassium ion channels by disease and pharmacological manipulation affect the cardiac patient, thus aiding in decision making when faced with clinical problems related to potassium.

Clinical and biochemical heterogeneity between patients with glycogen storage disease type IA: the added value of CUSUM for metabolic control.

PubMed

Peeks, Fabian; Steunenberg, Thomas A H; de Boer, Foekje; Rubio-Gozalbo, M Estela; Williams, Monique; Burghard, Rob; Rajas, Fabienne; Oosterveer, Maaike H; Weinstein, David A; Derks, Terry G J

2017-09-01

To study heterogeneity between patients with glycogen storage disease type Ia (GSD Ia), a rare inherited disorder of carbohydrate metabolism caused by the deficiency of glucose-6-phosphatase (G6Pase). Descriptive retrospective study of longitudinal clinical and biochemical data and long-term complications in 20 GSD Ia patients. We included 11 patients with homozygous G6PC mutations and siblings from four families carrying identical G6PC genotypes. To display subtle variations for repeated triglyceride measurements with respect to time for individual patients, CUSUM-analysis graphs were constructed. Patients with different homozygous G6PC mutations showed important differences in height, BMI, and biochemical parameters (i.e., lactate, uric acid, triglyceride, and cholesterol concentrations). Furthermore, CUSUM-analysis predicts and displays subtle changes in longitudinal blood triglyceride concentrations. Siblings in families also displayed important differences in biochemical parameters (i.e., lactate, uric acid, triglycerides, and cholesterol concentrations) and long-term complications (i.e., liver adenomas, nephropathy, and osteopenia/osteoporosis). Differences between GSD Ia patients reflect large clinical and biochemical heterogeneity. Heterogeneity between GSD Ia patients with homozygous G6PC mutations indicate an important role of the G6PC genotype/mutations. Differences between affected siblings suggest an additional role (genetic and/or environmental) of modifying factors defining the GSD Ia phenotype. CUSUM-analysis can facilitate single-patient monitoring of metabolic control and future application of this method may improve precision medicine for patients both with GSD and remaining inherited metabolic diseases.

Effective Strategies for Affordable Care Act Enrollment in Immigrant-Serving Safety Net Clinics in New Mexico.

PubMed

Getrich, Christina M; García, Jacqueline M; Solares, Angélica; Kano, Miria

2017-01-01

In the new Affordable Care Act (ACA) health care environment, safety-net institutions continue to serve as important sources of culturally appropriate care for different groups of immigrant patients. This article reports on a qualitative study examining the early ACA enrollment experiences of a range of health care providers (n = 29) in six immigrant-serving safety-net clinics in New Mexico. The six clinics configured their ACA enrollment strategies differently with regard to operations, staffing, and outreach. Providers reported a generally chaotic rollout overall and expressed frustration with strategies that did not accommodate patients, provided little training for providers, and engaged in minimal outreach. Conversely, providers lauded strategies that flexibly met patient needs, leveraged trust through strategic use of staff, and prioritized outreach. Findings underscore the importance of using and funding concerted strategies for future enrollment of immigrant patients, such as featuring community health workers and leveraging trust for outreach.

Clinical review: Neuromonitoring - an update

PubMed Central

2013-01-01

Critically ill patients are frequently at risk of neurological dysfunction as a result of primary neurological conditions or secondary insults. Determining which aspects of brain function are affected and how best to manage the neurological dysfunction can often be difficult and is complicated by the limited information that can be gained from clinical examination in such patients and the effects of therapies, notably sedation, on neurological function. Methods to measure and monitor brain function have evolved considerably in recent years and now play an important role in the evaluation and management of patients with brain injury. Importantly, no single technique is ideal for all patients and different variables will need to be monitored in different patients; in many patients, a combination of monitoring techniques will be needed. Although clinical studies support the physiologic feasibility and biologic plausibility of management based on information from various monitors, data supporting this concept from randomized trials are still required. PMID:23320763

RESPONSIVENESS OF THE ACTIVITIES OF DAILY LIVING SCALE OF THE KNEE OUTCOME SURVEY AND NUMERIC PAIN RATING SCALE IN PATIENTS WITH PATELLOFEMORAL PAIN

PubMed Central

Piva, Sara R.; Gil, Alexandra B.; Moore, Charity G.; Fitzgerald, G. Kelley

2016-01-01

Objective To assess internal and external responsiveness of the Activity of Daily Living Scale of the Knee Outcome Survey and Numeric Pain Rating Scale on patients with patellofemoral pain. Design One group pre-post design. Subjects A total of 60 individuals with patellofemoral pain (33 women; mean age 29.9 (standard deviation 9.6) years). Methods The Activity of Daily Living Scale and the Numeric Pain Rating Scale were assessed before and after 8 weeks of physical therapy program. Patients completed a global rating of change scale at the end of therapy. The standardized effect size, Guyatt responsiveness index, and the minimum clinical important difference were calculated. Results Standardized effect size of the Activity of Daily Living Scale was 0.63, Guyatt responsiveness index was 1.4, area under the curve was 0.83 (95% confidence interval: 0.72, 0.94), and the minimum clinical important difference corresponded to an increase of 7.1 percentile points. Standardized effect size of the Numeric Pain Rating Scale was 0.72, Guyatt responsiveness index was 2.2, area under the curve was 0.80 (95% confidence interval: 0.70, 0.92), and the minimum clinical important difference corresponded to a decrease of 1.16 points. Conclusion Information from this study may be helpful to therapists when evaluating the effectiveness of rehabilitation intervention on physical function and pain, and to power future clinical trials on patients with patellofemoral pain. PMID:19229444

Responsiveness of the activities of daily living scale of the knee outcome survey and numeric pain rating scale in patients with patellofemoral pain.

PubMed

Piva, Sara R; Gil, Alexandra B; Moore, Charity G; Fitzgerald, G Kelley

2009-02-01

To assess internal and external responsiveness of the Activity of Daily Living Scale of the Knee Outcome Survey and Numeric Pain Rating Scale on patients with patellofemoral pain. One group pre-post design. A total of 60 individuals with patellofemoral pain (33 women; mean age 29.9 (standard deviation 9.6) years). The Activity of Daily Living Scale and the Numeric Pain Rating Scale were assessed before and after 8 weeks of physical therapy program. Patients completed a global rating of change scale at the end of therapy. The standardized effect size, Guyatt responsiveness index, and the minimum clinical important difference were calculated. Standardized effect size of the Activity of Daily Living Scale was 0.63, Guyatt responsiveness index was 1.4, area under the curve was 0.83 (95% confidence interval: 0.72, 0.94), and the minimum clinical important difference corresponded to an increase of 7.1 percentile points. Standardized effect size of the Numeric Pain Rating Scale was 0.72, Guyatt responsiveness index was 2.2, area under the curve was 0.80 (95% confidence interval: 0.70, 0.92), and the minimum clinical important difference corresponded to a decrease of 1.16 points. Information from this study may be helpful to therapists when evaluating the effectiveness of rehabilitation intervention on physical function and pain, and to power future clinical trials on patients with patellofemoral pain.

Determining the minimal clinically important difference criteria for the Multidimensional Fatigue Inventory in a radiotherapy population.

PubMed

Purcell, Amanda; Fleming, Jennifer; Bennett, Sally; Burmeister, Bryan; Haines, Terry

2010-03-01

The Multidimensional Fatigue Inventory (MFI) is a commonly used cancer-related fatigue assessment tool. Unlike other fatigue assessments, there are no published minimal clinically important difference (MCID) criteria for the MFI in cancer populations. MCID criteria determine the smallest change in scores that can be regarded as important, allowing clinicians and researchers to interpret the meaning of changes in patient's fatigue scores. This research aims to improve the clinical utility of the MFI by establishing MCID criteria for the MFI sub-scales in a radiotherapy population. Two hundred ten patients undergoing radiotherapy were recruited to a single-centre prospective cohort study. Patients were assessed at three time points, at the start of radiotherapy, the end of radiotherapy and 6 weeks after radiotherapy completion. Assessment consisted of four clinically relevant constructs: (1) treatment impact on fatigue, (2) health-related quality of life, (3) performance status and (4) occupational productivity. These constructs were used as external or anchor-based measures to determine MCIDs for each sub-scale of the MFI. Multiple MCIDs were identified, each from a different perspective based on the constructs cited. Researchers seeking to use a generic MCID may wish to use a two-point reference for each MFI sub-scale as it was consistent across the pre- and post-radiotherapy comparison and occupational productivity anchors. MCIDs validated in this study allow better interpretation of changes in MFI sub-scale scores and allow effect size calculations for determining sample size in future studies.

Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example.

PubMed

Armijo-Olivo, Susan; Warren, Sharon; Fuentes, Jorge; Magee, David J

2011-12-01

Statistical significance has been used extensively to evaluate the results of research studies. Nevertheless, it offers only limited information to clinicians. The assessment of clinical relevance can facilitate the interpretation of the research results into clinical practice. The objective of this study was to explore different methods to evaluate the clinical relevance of the results using a cross-sectional study as an example comparing different neck outcomes between subjects with temporomandibular disorders and healthy controls. Subjects were compared for head and cervical posture, maximal cervical muscle strength, endurance of the cervical flexor and extensor muscles, and electromyographic activity of the cervical flexor muscles during the CranioCervical Flexion Test (CCFT). The evaluation of clinical relevance of the results was performed based on the effect size (ES), minimal important difference (MID), and clinical judgement. The results of this study show that it is possible to have statistical significance without having clinical relevance, to have both statistical significance and clinical relevance, to have clinical relevance without having statistical significance, or to have neither statistical significance nor clinical relevance. The evaluation of clinical relevance in clinical research is crucial to simplify the transfer of knowledge from research into practice. Clinical researchers should present the clinical relevance of their results. Copyright © 2011 Elsevier Ltd. All rights reserved.

African American women's perceptions of cancer clinical trials

PubMed Central

Haynes-Maslow, Lindsey; Godley, Paul; Dimartino, Lisa; White, Brandolyn; Odom, Janice; Richmond, Alan; Carpenter, William

2014-01-01

Cancer clinical trials are important for resolving cancer health disparities for several reasons; however, clinical trial participation among African Americans is significantly lower than Caucasians. This study engaged focus groups of 82 female African American cancer survivors or cancer caregivers, including those in better resourced, more urban areas and less resourced, more rural areas. Informed by an integrated conceptual model, the focus groups examined perceptions of cancer clinical trials and identified leverage points that future interventions may use to improve enrollment rates. Study findings highlight variation in community knowledge regarding cancer clinical trials, and the importance of community education regarding clinical trials and overcoming historical stigma associated with clinical research specifically and the health care system more generally. Study participants commented on the centrality of churches in their communities, and thus the promise of the church as loci of such education. Findings also suggested the value of informed community leaders as community information sources, including community members who have a previous diagnosis of cancer and clinical trial experience. The sample size and location of the focus groups may limit the generalizability of the results. Since the women in the focus groups were either cancer survivors or caregivers, they may have different experiences than nonparticipants who lack the close connection with cancer. Trust in the health system and in one's physician was seen as important factors associated with patient willingness to enroll in clinical trials, and participants suggested that physicians who were compassionate and who engaged and educated their patients would build important trust requisite for patient participation in clinical trials. PMID:24905181

Varieties of clinical reasoning.

PubMed

Bolton, Jonathan W

2015-06-01

Clinical reasoning comprises a variety of different modes of inference. The modes that are practiced will be influenced by the sociological characteristics of the clinical settings and the tasks to be performed by the clinician. This article presents C.S. Peirce's typology of modes of inference: deduction, induction and abduction. It describes their differences and their roles as stages in scientific argument. The article applies the typology to reasoning in clinical settings. The article describes their differences, and their roles as stages in scientific argument. It then applies the typology to reasoning in typical clinical settings. Abduction is less commonly taught or discussed than induction and deduction. However, it is a common mode of inference in clinical settings, especially when the clinician must try to make sense of a surprising phenomenon. Whether abduction is followed up with deductive and inductive verification is strongly influenced by situational constraints and the cognitive and psychological stamina of the clinician. Recognizing the inevitability of abduction in clinical practice and its value to discovery is important to an accurate understanding of clinical reasoning. © 2015 John Wiley & Sons, Ltd.

A comparison of policy and direct practice stakeholder perceptions of factors affecting evidence-based practice implementation using concept mapping

PubMed Central

2011-01-01

Background The goal of this study was to assess potential differences between administrators/policymakers and those involved in direct practice regarding factors believed to be barriers or facilitating factors to evidence-based practice (EBP) implementation in a large public mental health service system in the United States. Methods Participants included mental health system county officials, agency directors, program managers, clinical staff, administrative staff, and consumers. As part of concept mapping procedures, brainstorming groups were conducted with each target group to identify specific factors believed to be barriers or facilitating factors to EBP implementation in a large public mental health system. Statements were sorted by similarity and rated by each participant in regard to their perceived importance and changeability. Multidimensional scaling, cluster analysis, descriptive statistics and t-tests were used to analyze the data. Results A total of 105 statements were distilled into 14 clusters using concept-mapping procedures. Perceptions of importance of factors affecting EBP implementation varied between the two groups, with those involved in direct practice assigning significantly higher ratings to the importance of Clinical Perceptions and the impact of EBP implementation on clinical practice. Consistent with previous studies, financial concerns (costs, funding) were rated among the most important and least likely to change by both groups. Conclusions EBP implementation is a complex process, and different stakeholders may hold different opinions regarding the relative importance of the impact of EBP implementation. Implementation efforts must include input from stakeholders at multiple levels to bring divergent and convergent perspectives to light. PMID:21899754

A comparison of policy and direct practice stakeholder perceptions of factors affecting evidence-based practice implementation using concept mapping.

PubMed

Green, Amy E; Aarons, Gregory A

2011-09-07

The goal of this study was to assess potential differences between administrators/policymakers and those involved in direct practice regarding factors believed to be barriers or facilitating factors to evidence-based practice (EBP) implementation in a large public mental health service system in the United States. Participants included mental health system county officials, agency directors, program managers, clinical staff, administrative staff, and consumers. As part of concept mapping procedures, brainstorming groups were conducted with each target group to identify specific factors believed to be barriers or facilitating factors to EBP implementation in a large public mental health system. Statements were sorted by similarity and rated by each participant in regard to their perceived importance and changeability. Multidimensional scaling, cluster analysis, descriptive statistics and t-tests were used to analyze the data. A total of 105 statements were distilled into 14 clusters using concept-mapping procedures. Perceptions of importance of factors affecting EBP implementation varied between the two groups, with those involved in direct practice assigning significantly higher ratings to the importance of Clinical Perceptions and the impact of EBP implementation on clinical practice. Consistent with previous studies, financial concerns (costs, funding) were rated among the most important and least likely to change by both groups. EBP implementation is a complex process, and different stakeholders may hold different opinions regarding the relative importance of the impact of EBP implementation. Implementation efforts must include input from stakeholders at multiple levels to bring divergent and convergent perspectives to light.

Diagnostic challenges in tuberculous otitis media.

PubMed

Tang, I P; Prepageran, N; Ong, C A; Puraviappan, P

2010-08-01

To demonstrate the different clinical presentations of tuberculous otitis media and the management of selected cases. We report four cases of tuberculous otitis media with different clinical presentations, encountered between 1998 and 2002. None of the cases showed improvement with local or systemic antibiotics. The diagnosis, complications and management of these cases are discussed. A high index of clinical suspicion of tuberculous otitis media is required in patients who do not respond to standard antibiotic therapy for (nontuberculous) chronic middle-ear infection. Early diagnosis and treatment of tuberculous otitis media is important to avoid irreversible complications, surgical intervention and propagation of the disease.

Practitioner involvement in clinical evaluation.

PubMed

Penka, C E; Kirk, S A

1991-11-01

Contrary to popular belief, social workers are evaluating their practice, but what they do falls short of the use of quantitative procedures that researchers have promoted. Data obtained from a survey of social workers drawn from the National Association of Social Workers national membership list suggest that the gap between practitioners and clinical researchers may stem in part from different mindsets as well as from actual differences in the commitment to the importance of clinical evaluation. Moreover, in the minds of practitioners there appears to be a sharp distinction between formal single-subject design studies and the general evaluative tasks in which they routinely engage.

Differences in clinical reasoning among nurses working in highly specialised paediatric care.

PubMed

Andersson, Nina; Klang, Birgitta; Petersson, Gunilla

2012-03-01

The aim of the study was to examine differences in clinical reasoning among novice, experienced and specialist paediatric nurses. Highly specialised paediatric care requires specific knowledge and ongoing skill performance of the nurses employed. There is a lack of research in how paediatric nurses manage the daily care problems they encounter and how they acquire the skills required to give patients the best possible care. More knowledge is needed about how paediatric nurses with different experience and education reason and communicate about paediatric patient situations. The study was based on six recorded group discussions of a fictitious, but realistic paediatric case. Three categories of nurses: novices (n = 7), experienced (n = 7) and specialists (n = 7) from a paediatric hospital participated. A qualitative content analysis approach was chosen to examine differences in clinical reasoning. Several themes were uncovered: child's social situation, child abuse and the child's illness, qualitative differences emerged in how the nurses discussed the case. Three approaches were identified: a task-oriented approach (novices and experienced), an action-oriented approach (novices and experienced) and hypothesis-oriented approach (specialists) while discussing the case. When comparing nurses in three competence groups, it was established that the groups with extensive experience and specialist education reasoned differently than the other groups. Between the novice and experienced groups, no obvious differences were found. Thus, the importance of experience alone for the development of competence is still an open question. Experience combined with further education appears important for developing professional competence in paediatric care. Nurses' reasoning in clinical paediatric care is related to experience and training. © 2012 Blackwell Publishing Ltd.

TnSeq of Mycobacterium tuberculosis clinical isolates reveals strain-specific antibiotic liabilities

PubMed Central

Carey, Allison F.; Rock, Jeremy M.; Krieger, Inna V.; Gagneux, Sebastien; Sacchettini, James C.; Fortune, Sarah M.

2018-01-01

Once considered a phenotypically monomorphic bacterium, there is a growing body of work demonstrating heterogeneity among Mycobacterium tuberculosis (Mtb) strains in clinically relevant characteristics, including virulence and response to antibiotics. However, the genetic and molecular basis for most phenotypic differences among Mtb strains remains unknown. To investigate the basis of strain variation in Mtb, we performed genome-wide transposon mutagenesis coupled with next-generation sequencing (TnSeq) for a panel of Mtb clinical isolates and the reference strain H37Rv to compare genetic requirements for in vitro growth across these strains. We developed an analytic approach to identify quantitative differences in genetic requirements between these genetically diverse strains, which vary in genomic structure and gene content. Using this methodology, we found differences between strains in their requirements for genes involved in fundamental cellular processes, including redox homeostasis and central carbon metabolism. Among the genes with differential requirements were katG, which encodes the activator of the first-line antitubercular agent isoniazid, and glcB, which encodes malate synthase, the target of a novel small-molecule inhibitor. Differences among strains in their requirement for katG and glcB predicted differences in their response to these antimicrobial agents. Importantly, these strain-specific differences in antibiotic response could not be predicted by genetic variants identified through whole genome sequencing or by gene expression analysis. Our results provide novel insight into the basis of variation among Mtb strains and demonstrate that TnSeq is a scalable method to predict clinically important phenotypic differences among Mtb strains. PMID:29505613

Sex Differences in Drug Disposition

PubMed Central

Soldin, Offie P.; Chung, Sarah H.; Mattison, Donald R.

2011-01-01

Physiological, hormonal, and genetic differences between males and females affect the prevalence, incidence, and severity of diseases and responses to therapy. Understanding these differences is important for designing safe and effective treatments. This paper summarizes sex differences that impact drug disposition and includes a general comparison of clinical pharmacology as it applies to men and women. PMID:21403873

What makes a competent clinical teacher?

PubMed Central

Wealthall, Stephen; Henning, Marcus

2012-01-01

Background Clinical teaching competency is a professional necessity ensuring that clinicians’ knowledge, skills and attitudes are effectively transmitted from experts to novices. The aim of this paper is to consider how clinical skills are transmitted from a historical and reflective perspective and to link these ideas with student and teacher perceptions of competence in clinical teaching. Methods The reflections are informed by a Delphi process and professional development survey designed to capture students’ and clinicians’ ideas about the attributes of a competent clinical teacher. In addition, the survey process obtained information on the importance and ‘teachability’ of these characteristics. Results Four key characteristics of the competent teacher emerged from the Delphi process: clinically competent, efficient organizer, group communicator and person–centred. In a subsequent survey, students were found to be more optimistic about the ‘teachability’ of these characteristics than clinicians and scored the attribute of person-centredness higher than clinicians. Clinicians, on the other hand, ascribed higher levels of importance to clinical competency, efficient organization and group communication than students. Conclusions The Delphi process created a non-threatening system for gathering student and clinician expectations of teachers and created a foundation for developing methods for evaluating clinical competency. This provided insights into differences between teachers’ and students’ expectations, their importance, and professional development. PMID:26451184

Sex-based Differences in Common Sports Injuries.

PubMed

Carter, Cordelia W; Ireland, Mary Lloyd; Johnson, Anthony E; Levine, William N; Martin, Scott; Bedi, Asheesh; Matzkin, Elizabeth G

2018-05-28

The patient's sex plays an important role in mediating the risk for, and experience of, disease. Injuries of the musculoskeletal system are no exception to this phenomenon. Increasing evidence shows that the incidence, clinical presentation, and treatment outcomes for male and female patients with common sports injuries may vary widely. Stress fracture, which is associated with the female athlete triad, is a sports injury with known sex-based differences. Other common sports-related injuries may also have distinct sex-based differences. Understanding these differences is important to optimize each patient's musculoskeletal care.

Delayed Diagnoses in Children with Constipation: Multicenter Retrospective Cohort Study.

PubMed

Freedman, Stephen B; Rodean, Jonathan; Hall, Matthew; Alpern, Elizabeth R; Aronson, Paul L; Simon, Harold K; Shah, Samir S; Marin, Jennifer R; Cohen, Eyal; Morse, Rustin B; Katsogridakis, Yiannis; Berry, Jay G; Neuman, Mark I

2017-07-01

The use of abdominal radiographs contributes to increased healthcare costs, radiation exposure, and potentially to misdiagnoses. We evaluated the association between abdominal radiograph performance and emergency department (ED) revisits with important alternate diagnosis among children with constipation. Retrospective cohort study of children aged <18 years diagnosed with constipation at one of 23 EDs from 2004 to 2015. The primary exposure was abdominal radiograph performance. The primary outcome was a 3-day ED revisit with a clinically important alternate diagnosis. RAND/University of California, Los Angeles methodology was used to define whether the revisit was related to the index visit and due to a clinically important condition other than constipation. Regression analysis was performed to identify exposures independently related to the primary outcome. A total of 65.7% (185 439/282 225) of children with constipation had an index ED visit abdominal radiograph performed. Three-day revisits occurred in 3.7% (10 566/282 225) of children, and 0.28% (784/282 225) returned with a clinically important alternate related diagnosis. Appendicitis was the most common such revisit, accounting for 34.1% of all 3-day clinically important related revisits. Children who had an abdominal radiograph performed were more likely to have a 3-day revisit with a clinically important alternate related diagnosis (0.33% vs 0.17%; difference 0.17%; 95% CI 0.13-0.20). Following adjustment for covariates, abdominal radiograph performance was associated with a 3-day revisit with a clinically important alternate diagnosis (aOR: 1.39; 95% CI 1.15-1.67). Additional characteristics associated with the primary outcome included narcotic (aOR: 2.63) and antiemetic (aOR: 2.35) administration and underlying comorbidities (aOR: 2.52). Among children diagnosed with constipation, abdominal radiograph performance is associated with an increased risk of a revisit with a clinically important alternate related diagnosis. Copyright © 2017 Elsevier Inc. All rights reserved.

Assessment and manifestation of central sensitisation across different chronic pain conditions.

PubMed

Arendt-Nielsen, L; Morlion, B; Perrot, S; Dahan, A; Dickenson, A; Kress, H G; Wells, C; Bouhassira, D; Mohr Drewes, A

2018-02-01

Different neuroplastic processes can occur along the nociceptive pathways and may be important in the transition from acute to chronic pain and for diagnosis and development of optimal management strategies. The neuroplastic processes may result in gain (sensitisation) or loss (desensitisation) of function in relation to the incoming nociceptive signals. Such processes play important roles in chronic pain, and although the clinical manifestations differ across condition processes, they share some common mechanistic features. The fundamental understanding and quantitative assessment of particularly some of the central sensitisation mechanisms can be translated from preclinical studies into the clinic. The clinical perspectives are implementation of such novel information into diagnostics, mechanistic phenotyping, prevention, personalised treatment, and drug development. The aims of this paper are to introduce and discuss (1) some common fundamental central pain mechanisms, (2) how they may translate into the clinical signs and symptoms across different chronic pain conditions, (3) how to evaluate gain and loss of function using quantitative pain assessment tools, and (4) the implications for optimising prevention and management of pain. The chronic pain conditions selected for the paper are neuropathic pain in general, musculoskeletal pain (chronic low back pain and osteoarthritic pain in particular), and visceral pain (irritable bowel syndrome in particular). The translational mechanisms addressed are local and widespread sensitisation, central summation, and descending pain modulation. Central sensitisation is an important manifestation involved in many different chronic pain conditions. Central sensitisation can be different to assess and evaluate as the manifestations vary from pain condition to pain condition. Understanding central sensitisation may promote better profiling and diagnosis of pain patients and development of new regimes for mechanism based therapy. Some of the mechanisms underlying central sensitisation can be translated from animals to humans providing new options in development of therapies and profiling drugs under development. © 2017 European Pain Federation - EFIC®.

A Completed Cycle Audit of Psychiatric Discharge Summaries.

PubMed

Najim, Hellme; Jaffar, Khalid

2015-09-01

Patients discharge summaries are important as they record a vital miles stone in patients' care. Their accurate record improves patients' care and clarifies communication between different health professionals. 60 Discharge summaries from different consultant psychiatrists' case load were audited. The results were analysed and presented with recommendations to improve them a format was suggested. A reaudit of 62 discharge summaries was carried out by the same team after three years in the same catchment area but the practice has changed to inpatient and community. Improvement in most of the areas audited occur in the reaudit which indicates the usefulness of audit in improving clinical practice which a pivotal part of clinical governance. This completed audit cycle has proven that clinical practice has been reviewed and methods of improving it have been implemented. It has been noted that more items were reviewed and added to the second cycle which should be condoned. Discharge summaries are important clinical documents in secondary and primary care communications. They are helpful for secondary care staff as they good references for people in out of hours services and Accident and Emergency. Good quality discharge summaries improve patients care and make it easy to manage clinical risk.

Professional challenges and opportunities in clinical microbiology and infectious diseases in Europe.

PubMed

Read, Robert C; Cornaglia, Giuseppe; Kahlmeter, Gunnar

2011-05-01

The two closely linked specialties of clinical microbiology and infectious diseases face important challenges. We report the consensus of clinical microbiologists and infectious disease physicians assembled by the European Society for Clinical Microbiology and Infectious Diseases. Both specialties have different training requirements in different European countries and are not universally recognised as professions. The specialties are rapidly evolving as they adapt to the changing demands within hospital practice, including the need to deal with emerging infections, rapidly increasing internationalisation, and immigration. Clinical microbiology needs to develop and master technological advances such as laboratory automation and an avalanche of new methods for rapid diagnostics. Simultaneously, the pressure for concentration, amalgamation, and out-sourcing of laboratory services is ever-increasing. Infectious disease physicians have to meet the professional challenge of subspecialisation and the continual need to find new niches for their skills. Despite these challenges, each of these specialties continues to thrive in Europe and will enjoy important opportunities over the next few years. The recently formed European Centre for Disease Prevention and Control in Stockholm, Sweden, will increase demands in areas of surveillance of infectious diseases and antimicrobial resistance on both specialties. Copyright © 2011 Elsevier Ltd. All rights reserved.

A Comparative, Developmental, and Clinical Perspective of Neurobehavioral Sexual Dimorphisms

PubMed Central

Viveros, Maria-Paz; Mendrek, Adriana; Paus, Tomáš; López-Rodríguez, Ana Belén; Marco, Eva Maria; Yehuda, Rachel; Cohen, Hagit; Lehrner, Amy; Wagner, Edward J.

2012-01-01

Women and men differ in a wide variety of behavioral traits and in their vulnerability to developing certain mental disorders. This review endeavors to explore how recent preclinical and clinical research findings have enhanced our understanding of the factors that underlie these disparities. We start with a brief overview of some of the important genetic, molecular, and hormonal determinants that contribute to the process of sexual differentiation. We then discuss the importance of animal models in studying the mechanisms responsible for sex differences in neuropsychiatric disorders (e.g., drug dependence) – with a special emphasis on experimental models based on the neurodevelopmental and “three hits” hypotheses. Next, we describe the most common brain phenotypes observed in vivo with magnetic resonance imaging. We discuss the challenges in interpreting these phenotypes vis-à-vis the underlying neurobiology and revisit the known sex differences in brain structure from birth, through adolescence, and into adulthood. This is followed by a presentation of pertinent clinical and epidemiological data that point to important sex differences in the prevalence, course, and expression of psychopathologies such as schizophrenia, and mood disorders including major depression and posttraumatic stress disorder. Recent evidence implies that mood disorders and psychosis share some common genetic predispositions and neurobiological bases. Therefore, modern research is emphasizing dimensional representation of mental disorders and conceptualization of schizophrenia and major depression as a continuum of cognitive deficits and neurobiological abnormalities. Herein, we examine available evidence on cerebral sexual dimorphism to verify if sex differences vary quantitatively and/or qualitatively along the psychoses-depression continuum. Finally, sex differences in the prevalence of posttraumatic disorder and drug abuse have been described, and we consider the genomic and molecular data supporting these differences. PMID:22701400

A virtual dosimetry audit - Towards transferability of gamma index analysis between clinical trial QA groups.

PubMed

Hussein, Mohammad; Clementel, Enrico; Eaton, David J; Greer, Peter B; Haworth, Annette; Ishikura, Satoshi; Kry, Stephen F; Lehmann, Joerg; Lye, Jessica; Monti, Angelo F; Nakamura, Mitsuhiro; Hurkmans, Coen; Clark, Catharine H

2017-12-01

Quality assurance (QA) for clinical trials is important. Lack of compliance can affect trial outcome. Clinical trial QA groups have different methods of dose distribution verification and analysis, all with the ultimate aim of ensuring trial compliance. The aim of this study was to gain a better understanding of different processes to inform future dosimetry audit reciprocity. Six clinical trial QA groups participated. Intensity modulated treatment plans were generated for three different cases. A range of 17 virtual 'measurements' were generated by introducing a variety of simulated perturbations (such as MLC position deviations, dose differences, gantry rotation errors, Gaussian noise) to three different treatment plan cases. Participants were blinded to the 'measured' data details. Each group analysed the datasets using their own gamma index (γ) technique and using standardised parameters for passing criteria, lower dose threshold, γ normalisation and global γ. For the same virtual 'measured' datasets, different results were observed using local techniques. For the standardised γ, differences in the percentage of points passing with γ < 1 were also found, however these differences were less pronounced than for each clinical trial QA group's analysis. These variations may be due to different software implementations of γ. This virtual dosimetry audit has been an informative step in understanding differences in the verification of measured dose distributions between different clinical trial QA groups. This work lays the foundations for audit reciprocity between groups, particularly with more clinical trials being open to international recruitment. Copyright © 2017 Elsevier B.V. All rights reserved.

Patient-specific bone modeling and analysis: the role of integration and automation in clinical adoption.

PubMed

Zadpoor, Amir A; Weinans, Harrie

2015-03-18

Patient-specific analysis of bones is considered an important tool for diagnosis and treatment of skeletal diseases and for clinical research aimed at understanding the etiology of skeletal diseases and the effects of different types of treatment on their progress. In this article, we discuss how integration of several important components enables accurate and cost-effective patient-specific bone analysis, focusing primarily on patient-specific finite element (FE) modeling of bones. First, the different components are briefly reviewed. Then, two important aspects of patient-specific FE modeling, namely integration of modeling components and automation of modeling approaches, are discussed. We conclude with a section on validation of patient-specific modeling results, possible applications of patient-specific modeling procedures, current limitations of the modeling approaches, and possible areas for future research. Copyright © 2014 Elsevier Ltd. All rights reserved.

Improved understanding of the pathophysiology of atrial fibrillation through the lens of discrete pathological pathways

PubMed Central

Balouch, Muhammad A.; Kolek, Matthew J.; Darbar, Dawood

2014-01-01

Atrial fibrillation (AF) is a common disorder with a complex and incompletely understood pathophysiology. Genetic approaches to understanding the pathophysiology of AF have led to the identification of several biological pathways important in the pathogenesis of the arrhythmia. These include pathways important for cardiac development, generation and propagation of atrial electrical impulses, and atrial remodeling and fibrosis. While common and rare genetic variants in these pathways are associated with increased susceptibility to AF, they differ substantially among patients with lone versus typical AF. Furthermore, how these pathways converge to a final common clinical phenotype of AF is unclear and might also vary among different patient populations. Here, we review the contemporary knowledge of AF pathogenesis and discuss how derangement in cardiac development, ion channel dysfunction, and promotion of atrial fibrosis may contribute to this common and important clinical disorder. PMID:25054116

Differences between clinical "snap-shot" and "real-life" assessments of lumbar spine alignment and motion - What is the "real" lumbar lordosis of a human being?

PubMed

Dreischarf, Marcel; Pries, Esther; Bashkuev, Maxim; Putzier, Michael; Schmidt, Hendrik

2016-03-21

The individual lumbar lordosis and lumbar motion have been identified to play an important role in pathogenesis of low back pain and are essential references for preoperative planning and postoperative evaluation. The clinical "gold-standard" for measuring lumbar lordosis and its motion are radiological "snap-shots" taken while standing and during upper-body flexion and extension. The extent to which these clinically assessed values characterise lumbar alignment and its motion in daily life merits discussion. A non-invasive measurement-system was employed to measure lumbar lordosis and lumbar motion in 208 volunteers (age: 20-74yrs; ♀/♂: 115/93). For an initial short-term measurement, comparable with the clinical "snap-shot", lumbar lordosis and its motion were assessed while standing and during flexion and extension. Subsequently, volunteers were released to their daily lives while wearing the device, and measurements were performed during the following 24h. The average lumbar lordosis during 24h (8.0°) differed significantly from the standardised measurement while standing (33.3°). Ranges of motion were significantly different throughout the day compared to standing measurements. The influence of the factors age and gender on lordosis and its motion resulted in conflicting results between long- and short-term-measurements. In conclusion, results of short-term examinations differ considerably from the average values during real-life. These findings might be important for surgical planning and increase the awareness of the biomechanical challenges that spinal structures and implants face in real-life. Furthermore, long-term assessments of spinal alignment and motion during daily life can provide valid data on spinal function and can reveal the importance of influential factors. Copyright © 2016 Elsevier Ltd. All rights reserved.

Electroencephalography signatures of attention-deficit/hyperactivity disorder: clinical utility.

PubMed

Alba, Guzmán; Pereda, Ernesto; Mañas, Soledad; Méndez, Leopoldo D; González, Almudena; González, Julián J

2015-01-01

The techniques and the most important results on the use of electroencephalography (EEG) to extract different measures are reviewed in this work, which can be clinically useful to study subjects with attention-deficit/hyperactivity disorder (ADHD). First, we discuss briefly and in simple terms the EEG analysis and processing techniques most used in the context of ADHD. We review techniques that both analyze individual EEG channels (univariate measures) and study the statistical interdependence between different EEG channels (multivariate measures), the so-called functional brain connectivity. Among the former ones, we review the classical indices of absolute and relative spectral power and estimations of the complexity of the channels, such as the approximate entropy and the Lempel-Ziv complexity. Among the latter ones, we focus on the magnitude square coherence and on different measures based on the concept of generalized synchronization and its estimation in the state space. Second, from a historical point of view, we present the most important results achieved with these techniques and their clinical utility (sensitivity, specificity, and accuracy) to diagnose ADHD. Finally, we propose future research lines based on these results.

Stakeholder Perceptions, Learning Opportunities, and Student Outcomes in Three Clinical Learning Models.

PubMed

Hendricks, Susan; DeMeester, Deborah; Stephenson, Evelyn; Welch, Janet

2016-05-01

Understanding the strengths and challenges of various clinical models is important for nursing education. Three long-standing clinical models (preceptored, hybrid, and traditional) were compared on several outcome measures related to satisfaction, learning opportunities, and student outcomes. Students, faculty, and preceptors participated in this study. Although no differences were noted in satisfaction or standardized examination scores, students in the preceptored clinical model were able to practice more psychomotor skills. Although participants in the preceptored model reported spending more time communicating with staff nurses than did those in the other models, students in the traditional model spent more time with faculty. No differences were noted among groups in student clinical observation time. All clinical learning models were focused on how clinical time was structured, without an emphasis on how faculty and preceptors work with students to develop nursing clinical reasoning skills. Identifying methodology to impact thinking in the clinical environment is a key next step. [J Nurs Educ. 2016;55(5):271-277.]. Copyright 2016, SLACK Incorporated.

Healthcare Reform and Preparing the Future Clinical Child and Adolescent Psychology Workforce.

PubMed

Janicke, David M; Fritz, Alyssa M; Rozensky, Ronald H

2015-01-01

The healthcare environment is undergoing important changes for both patients and providers, in part due to the Patient Protection and Affordable Care Act (ACA). Ultimately the healthcare delivery system will function very differently by the end of this decade. These changes will have important implications for the education, training, scientific inquiry, and practice of clinical child and adolescent psychologists. In this article we provide a brief description of the fundamental features of the ACA, with a specific focus on critical components of the act that have important, specific implications for clinical child and adolescents psychologists. We then provide recommendations to help position our field to thrive in the evolving healthcare environment to help facilitate further awareness and promote discussion of both challenges and opportunities that face our field in this evolving health care environment.

77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

... trials and device study design. Date and Time: The public workshop will be held on November 27, 2012... problem for PRO instruments. There have been various methodological approaches to determine MCID for... rationales for regulatory guidance of clinical trials and device study design. Approximately 45 days after...

Nurse teacher models in clinical education from the perspective of student nurses--A mixed method study.

PubMed

Gustafsson, Margareta; Kullén Engström, Agneta; Ohlsson, Ulla; Sundler, Annelie J; Bisholt, Birgitta

2015-12-01

The aim was to describe and compare the clinical teacher's role in different models of clinical practice from the perspective of student nurses. The study took place in collaboration with two Swedish universities that applied different educational models in clinical practice. A mixed method approach was used. The quantitative part had a comparative design and the qualitative part had a descriptive design. The study group consisted of 114 student nurses (response rate 87%). Fifty-three of them had met clinical teachers employed at the university and not participating in the daily clinical work (University Nurse Teachers, UNTs), whilst 61 had met clinical teachers dividing their time between teaching and nursing (Clinical Nurse Teachers, CNTs). Eight students participated in the qualitative part of the study. A questionnaire including the CLES+T scale was used to ascertain the students' perception of the clinical teacher's role, complemented by interviews directed towards an enrichment of this perception. Students meeting CNTs agreed more strongly than those meeting UNTs that the teacher had the ability to help them integrate theory and practice. Whilst spontaneous meetings between students and CNTs occurred, students mostly met UNTs in seminars. Students meeting UNTs felt alone but did appreciate having someone outside the clinical environment to provide support if they did not get along with their preceptor. In the case of UNTs, it is important that they keep their knowledge of clinical issues updated and visit the clinical placement not only for seminars but also to give students emotional support. In the case of CNTs, it is important that they are members of the faculty at the university, take part in the planning of the clinical courses and are able to explain the learning goals to the students. Copyright © 2015 Elsevier Ltd. All rights reserved.

Commercially pure titanium (cp-Ti) versus titanium alloy (Ti6Al4V) materials as bone anchored implants - Is one truly better than the other?

PubMed

Shah, Furqan A; Trobos, Margarita; Thomsen, Peter; Palmquist, Anders

2016-05-01

Commercially pure titanium (cp-Ti) and titanium alloys (typically Ti6Al4V) display excellent corrosion resistance and biocompatibility. Although the chemical composition and topography are considered important, the mechanical properties of the material and the loading conditions in the host have, conventionally, influenced material selection for different clinical applications: predominantly Ti6Al4V in orthopaedics while cp-Ti in dentistry. This paper attempts to address three important questions: (i) To what extent do the surface properties differ when cp-Ti and Ti6Al4V materials are manufactured with the same processing technique?, (ii) Does bone tissue respond differently to the two materials, and (iii) Do bacteria responsible for causing biomaterial-associated infections respond differently to the two materials? It is concluded that: (i) Machined cp-Ti and Ti6Al4V exhibit similar surface morphology, topography, phase composition and chemistry, (ii) Under experimental conditions, cp-Ti and Ti6Al4V demonstrate similar osseointegration and biomechanical anchorage, and (iii) Experiments in vitro fail to disclose differences between cp-Ti and Ti6Al4V to harbour Staphylococcus epidermidis growth. No clinical comparative studies exist which could determine if long-term, clinical differences exist between the two types of bulk materials. It is debatable whether cp-Ti or Ti6Al4V exhibit superiority over the other, and further comparative studies, particularly in a clinical setting, are required. Copyright © 2016 Elsevier B.V. All rights reserved.

Peri-implant and periodontal tissues: a review of differences and similarities.

PubMed

Dhir, Sangeeta; Mahesh, Lanka; Kurtzman, Gregori M; Vandana, K L

2013-01-01

The health and vitality of an osseointegrated implant depends on the surrounding supporting tissues, which not only anchor the implant to the bone but also have the important function of providing a protective seal. The aim of this article is to provide a basic understanding of differences and similarities between the periodontal and peri-implant tissues at the histologic, clinical, and immunologic levels; it is essential to know these differences and similarities during the clinical handling of these similar-looking tissues. The comparative features are of clinical relevance because it is critical to understand the behavior of the soft tissue found around the tooth and implant. This knowledge is vital from the preliminary stage of treatment planning through prosthetic rehabilitation.

A multicenter study: how do medical students perceive clinical learning climate?

PubMed

Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

2016-01-01

The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students' perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students' interactions in clinical settings, self-realization, mood, students' intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve clinical learning climate.

A multicenter study: how do medical students perceive clinical learning climate?

PubMed

Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

2016-01-01

Background The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students' perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Methods Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). Results The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. Conclusion The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students' interactions in clinical settings, self-realization, mood, students' intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve clinical learning climate.

How we see others: the psychobiology of schemas and transference.

PubMed

Stein, Dan J

2009-01-01

Social cognition involves automatic and stimulus-driven processes; these may be important in mediating stereotypes in the community and schemas and transference in the clinic setting. Significant differences in self-related processing and other-related processing may also lead to important biases in our view of the other. The psychobiology of social cognition is gradually being delineated, and may be useful in understanding these phenomena, and in responding appropriately. In the clinic, schemas can be rigorously assessed, and schema-focused psychotherapy may be useful in a number of indications.

Differing approaches to falls and fracture prevention between Australia and Colombia

PubMed Central

Gomez, Fernando; Curcio, Carmen Lucia; Suriyaarachchi, Pushpa; Demontiero, Oddom; Duque, Gustavo

2013-01-01

Falls and fractures are major causes of morbidity and mortality in older people. More importantly, previous falls and/or fractures are the most important predictors of further events. Therefore, secondary prevention programs for falls and fractures are highly needed. However, the question is whether a secondary prevention model should focus on falls prevention alone or should be implemented in combination with fracture prevention. By comparing a falls prevention clinic in Manizales (Colombia) versus a falls and fracture prevention clinic in Sydney (Australia), the objective was to identify similarities and differences between these two programs and to propose an integrated model of care for secondary prevention of fall and fractures. A comparative study of services was performed using an internationally agreed taxonomy. Service provision was compared against benchmarks set by the National Institute for Health and Clinical Excellence (NICE) and previous reports in the literature. Comparison included organization, administration, client characteristics, and interventions. Several similarities and a number of differences that could be easily unified into a single model are reported here. Similarities included population, a multidisciplinary team, and a multifactorial assessment and intervention. Differences were eligibility criteria, a bone health assessment component, and the therapeutic interventions most commonly used at each site. In Australia, bone health assessment is reinforced whereas in Colombia dizziness assessment and management is pivotal. The authors propose that falls clinic services should be operationally linked to osteoporosis services such as a “falls and fracture prevention clinic,” which would facilitate a comprehensive intervention to prevent falls and fractures in older persons. PMID:23378748

[The nurses involved in therapeutic innovation].

PubMed

Cheron, Coralie

2016-03-01

Clinical research nurses (CRNs) play an important role within the teams involved in the fight against cancer and in therapeutic innovation. In the dermatology department of the Gustave-Roussy Institute, patients treated for melanoma and taking part in clinical trials are supported along their care pathway by a CRN who, in addition to her clinical expertise, acts as a link between the different players concerned. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

PubMed Central

Jones, Paul W; Rennard, Stephen; Tabberer, Maggie; Riley, John H; Vahdati-Bolouri, Mitra; Barnes, Neil C

2016-01-01

One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs) in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique) the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of the study population. For the practising clinician, the most important consideration is the importance of individualization of treatment (and of treatment goals). To inform such treatment, clinicians need to critically review PRO data. The hope is that the questions posed here will help to build a framework for this critical review. PMID:27994447

Approaches to preparing young scholars for careers in interdisciplinary team science.

PubMed

Begg, Melissa D; Crumley, Gene; Fair, Alecia M; Martina, Camille A; McCormack, Wayne T; Merchant, Carol; Patino-Sutton, Cecilia M; Umans, Jason G

2014-01-01

To succeed as a biomedical researcher, the ability to flourish in interdisciplinary teams of scientists is becoming ever more important. Institutions supported by the Clinical and Translational Science Awards (CTSAs) from the National Institutes of Health have a specific mandate to educate the next generation of clinical and translational researchers. While they strive to advance integrated and interdisciplinary approaches to education and career development in clinical and translational science, general approaches and evaluation strategies may differ, as there is no single, universally accepted or standardized approach. It is important, therefore, to learn about the different approaches used to determine what is effective. We implemented a Web-based survey distributed to education leaders at the 60 funded CTSA institutions; 95% responded to the survey, which included questions on the importance of preparation for interdisciplinary team science careers, methods used to provide such training, and perceived effectiveness of these training programs. The vast majority (86%) of education leaders reported that such training is important, and about half (52%) of the institutions offer such training. Methods of training most often take the form of courses and seminars, both credit bearing and noncredit. These efforts are, by and large, perceived as effective by the training program leaders, although long-term follow-up of trainees would be required to fully evaluate ultimate effectiveness. Results from the survey suggest that CTSA education directors believe that specific training in interdisciplinary team science for young investigators is very important, but few methodologies are universally practiced in CTSA institutions to provide training or to assess performance. Four specific recommendations are suggested to provide measurable strategic goals for education in team science in the context of clinical and translational research.

Interpreting patient-reported outcomes from clinical trials in COPD: a discussion.

PubMed

Jones, Paul W; Rennard, Stephen; Tabberer, Maggie; Riley, John H; Vahdati-Bolouri, Mitra; Barnes, Neil C

2016-01-01

One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs) in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique) the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George's Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of the study population. For the practising clinician, the most important consideration is the importance of individualization of treatment (and of treatment goals). To inform such treatment, clinicians need to critically review PRO data. The hope is that the questions posed here will help to build a framework for this critical review.

Impact of the site specialty of a continuity practice on students' clinical skills: performance with standardized patients.

PubMed

Pfeiffer, Carol A; Palley, Jane E; Harrington, Karen L

2010-07-01

The assessment of clinical competence and the impact of training in ambulatory settings are two issues of importance in the evaluation of medical student performance. This study compares the clinical skills performance of students placed in three types of community preceptors' offices (pediatrics, medicine, family medicine) on yearly clinical skills assessments with standardized patients. Our goal was to see if the site specialty impacted on clinical performance. The students in the study were completing a 3-year continuity preceptorship at a site representing one of the disciplines. Their performance on the four clinical skills assessments was compared. There was no significant difference in history taking, physical exam, communication, or clinical reasoning in any year (ANOVA p< or = .05) There was a small but significant difference in performance on a measure of interpersonal and interviewing skills during Years 1 and 2. The site specialty of an early clinical experience does not have a significant impact on performance of most of the skills measured by the assessments.

Occult Hepatitis B (OBH) in Clinical Settings

PubMed Central

Alavian, Seyed Moayed; Miri, Seyed Mohammad; Hollinger, F. Blaine; Jazayeri, Seyed Mohammad

2012-01-01

Context Occult hepatitis B (OHB), or persistent HBV DNA in patients who are hepatitis B surface antigen (HBsAg) negative, is a recently recognized entity. In an attempt to summarize the issues, this review presents an overview of the current proposed hypothesis on the clinical relevance and also updates the knowledge on the classification of OHB in different clinical settings. Evidence Acquisition OHB could be found in different population and clinical backgrounds including: viral co-infections (with either human immunodeficiency or hepatitis C viruses), HBV chronic carriers, dialysis patients, transplantation settings and certain clinical situations (named in here: special clinical settings) with no apparent distinguishable clinical parameters. Results The exact magnitude, pathogenesis, and clinical relevance of OHB are unclear. Even the possible role exerted by this cryptic infection on liver disease outcome, and hepatocellular carcinoma development remains unknown. Conclusions Monitoring of Individuals with positive anti-HBc, mass immunization programs and improvement in diagnostic tools seem to be important to control the probability of transmission of HBV through cryptic HBV infection. PMID:23087749

Clinical audit, a valuable tool to improve quality of care: General methodology and applications in nephrology.

PubMed

Esposito, Pasquale; Dal Canton, Antonio

2014-11-06

Evaluation and improvement of quality of care provided to the patients are of crucial importance in the daily clinical practice and in the health policy planning and financing. Different tools have been developed, including incident analysis, health technology assessment and clinical audit. The clinical audit consist of measuring a clinical outcome or a process, against well-defined standards set on the principles of evidence-based medicine in order to identify the changes needed to improve the quality of care. In particular, patients suffering from chronic renal diseases, present many problems that have been set as topics for clinical audit projects, such as hypertension, anaemia and mineral metabolism management. Although the results of these studies have been encouraging, demonstrating the effectiveness of audit, overall the present evidence is not clearly in favour of clinical audit. These findings call attention to the need to further studies to validate this methodology in different operating scenarios. This review examines the principle of clinical audit, focusing on experiences performed in nephrology settings.

Primary-Care Weight-Management Strategies: Parental Priorities and Preferences

PubMed Central

Turer, Christy Boling; Upperman, Carla; Merchant, Zahra; Montaño, Sergio; Flores, Glenn

2015-01-01

Objective Examine parental perspectives/rankings of the most important weight-management clinical practices; and, determine whether preferences/rankings differ when parents disagree that their child is overweight. Methods Mixed-methods analysis of a 32-question survey of parents of 2-18 year-old overweight children assessing parental agreement that their child is overweight, the single most important thing providers can do to improve weight status, ranking AAP-recommended clinical practices, and preferred follow-up interval. Four independent reviewers analyzed open-response data to identify qualitative themes/subthemes. Multivariable analyses examined parental rankings, preferred follow-up interval, and differences by agreement with their child’s overweight assessment. Results Thirty-six percent of 219 children were overweight, 42% were obese, and 22% severely obese; 16% of parents disagreed with their child’s overweight assessment. Qualitative analysis of the most important practice to help overweight children yielded 10 themes; unique to parents disagreeing with their children’s overweight assessments was, “change weight-status assessments.” After adjustment, the three highest-ranked clinical practices included, “check for weight-related problems,” “review growth chart,” and “recommend general dietary changes” (all P<.01);” parents disagreeing with their children’s overweight assessments ranked “review growth chart” as less important, and “reducing screen time” and “general activity changes” as more important. The mean preferred weight-management follow-up interval (10-12 weeks) did not differ by agreement with children’s overweight assessments. Conclusions Parents prefer weight-management strategies that prioritize evaluating weight-related problems, growth-chart review, and regular follow-up. Parents who disagree that their child is overweight want changes in how overweight is assessed. Using parent-preferred weight-management strategies may prove useful in improving child weight status. PMID:26514648

Primary-Care Weight-Management Strategies: Parental Priorities and Preferences.

PubMed

Turer, Christy Boling; Upperman, Carla; Merchant, Zahra; Montaño, Sergio; Flores, Glenn

2016-04-01

To examine parental perspectives/rankings of the most important weight-management clinical practices and to determine whether preferences/rankings differ when parents disagree that their child is overweight. We performed mixed-methods analysis of a 32-question survey of parents of 2- to 18-year-old overweight children assessing parental agreement that their child is overweight, the single most important thing providers can do to improve weight status, ranking American Academy of Pediatrics-recommended clinical practices, and preferred follow-up interval. Four independent reviewers analyzed open-response data to identify qualitative themes/subthemes. Multivariable analyses examined parental rankings, preferred follow-up interval, and differences by agreement with their child's overweight assessment. Thirty-six percent of 219 children were overweight, 42% obese, and 22% severely obese; 16% of parents disagreed with their child's overweight assessment. Qualitative analysis of the most important practice to help overweight children yielded 10 themes; unique to parents disagreeing with their children's overweight assessments was "change weight-status assessments." After adjustment, the 3 highest-ranked clinical practices included, "check for weight-related problems," "review growth chart," and "recommend general dietary changes" (all P < .01); parents disagreeing with their children's overweight assessments ranked "review growth chart" as less important and ranked "reducing screen time" and "general activity changes" as more important. The mean preferred weight-management follow-up interval (10-12 weeks) did not differ by agreement with children's overweight assessments. Parents prefer weight-management strategies that prioritize evaluating weight-related problems, growth-chart review, and regular follow-up. Parents who disagree that their child is overweight want changes in how overweight is assessed. Using parent-preferred weight-management strategies may prove useful in improving child weight status. Copyright © 2016 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Pharmacological differences and clinical implications of various botulinum toxin preparations: a critical appraisal

PubMed Central

Ferrari, Adriano; Manca, Mario; Tugnoli, Valeria

2018-01-01

Summary Three different type A botulinum neurotoxins (BoNTAs) — onabotulinumtoxinA, abobotulinumtoxinA and incobotulinumtoxinA) — are currently marketed in Europe to treat several conditions. Differences between BoNTA preparations, which depend on their specific biotypes and manufacturing processes, lead to clinically relevant pharmacotherapeutic dissimilarities. All three available products are separately recognized and reviewed in American Academy of Neurology guidelines. The neurotoxin load/100U is likewise different among the different BoNTAs, with the result that the specific potency of the 150kD BoNTA neurotoxin is calculated as 137 units/ng for onabotulinumtoxinA, 154 units/ng for abobotulinumtoxinA, and 227 units/ng for incobotulinumtoxinA. It is important for clinicians to have all three BoNTAs available in order to choose the most suitable preparation for the specific indication in the single patient. Commercially available BoNTAs must be recognized as different from one another, and therefore as non-interchangeable. The essential experience of the clinician is of the utmost importance in choosing the most appropriate treatment. PMID:29633692

Clinical trials involving cats: what factors affect owner participation?

PubMed

Gruen, Margaret E; Jiamachello, Katrina N; Thomson, Andrea; Lascelles, B Duncan X

2014-09-01

Clinical trials are frequently hindered by difficulties in recruiting eligible participants, increasing the timeline and limiting generalizability of results. In veterinary medicine, where proxy enrollment is required, no studies have detailed what factors influence owner participation in clinical trials involving cats. We aimed to investigate these factors through a survey of owners at first opinion practices. The survey was designed using feedback from a pilot study and input from clinical researchers. Owners were asked demographic questions and whether they would, would not, or were unsure about participating in a clinical trial with their cat. They then ranked the importance and influence of various factors on participation using a five-point Likert-type scale, and incentives from most to least encouraging. A total of 413 surveys were distributed to cat owners at four hospitals, two feline-only and two multi-species; 88.6% were completed. Data for importance and influence factors as well as incentive rankings were analyzed overall, and by hospital type, location and whether owners would consider participating. The most influential factors were trust in the organization, benefit to the cat and veterinarian recommendation. Importance and influence factors varied by willingness to participate. Ranked incentives were not significantly different across groups, with 'Free Services' ranked highest. This study provides a first look at what factors influence participation in clinical trials with cats. Given the importance placed in the recommendation of veterinarians, continued work is needed to determine veterinarian-related factors affecting clinical trial participation. The results provide guidance towards improved clinical trial design, promotion and education. © ISFM and AAFP 2014.

Is the diagnostic threshold for bulimia nervosa clinically meaningful?

PubMed

Chapa, Danielle A N; Bohrer, Brittany K; Forbush, Kelsie T

2018-01-01

The DSM-5 differentiates full- and sub-threshold bulimia nervosa (BN) according to average weekly frequencies of binge eating and inappropriate compensatory behaviors. This study was the first to evaluate the modified frequency criterion for BN published in the DSM-5. The purpose of this study was to test whether community-recruited adults (N=125; 83.2% women) with current full-threshold (n=77) or sub-threshold BN (n=48) differed in comorbid psychopathology and eating disorder (ED) illness duration, symptom severity, and clinical impairment. Participants completed the Clinical Impairment Assessment and participated in semi-structured clinical interviews of ED- and non-ED psychopathology. Differences between the sub- and full-threshold BN groups were assessed using MANOVA and Chi-square analyses. ED illness duration, age-of-onset, body mass index (BMI), alcohol and drug misuse, and the presence of current and lifetime mood or anxiety disorders did not differ between participants with sub- and full-threshold BN. Participants with full-threshold BN had higher levels of clinical impairment and weight concern than those with sub-threshold BN. However, minimal clinically important difference analyses suggested that statistically significant differences between participants with sub- and full-threshold BN on clinical impairment and weight concern were not clinically significant. In conclusion, sub-threshold BN did not differ from full-threshold BN in clinically meaningful ways. Future studies are needed to identify an improved frequency criterion for BN that better distinguishes individuals in ways that will more validly inform prognosis and effective treatment planning for BN. Copyright © 2017 Elsevier Ltd. All rights reserved.

Sex Differences and Sex Steroids in Lung Health and Disease

PubMed Central

Townsend, Elizabeth A.; Miller, Virginia M.

2012-01-01

Sex differences in the biology of different organ systems and the influence of sex hormones in modulating health and disease are increasingly relevant in clinical and research areas. Although work has focused on sex differences and sex hormones in cardiovascular, musculoskeletal, and neuronal systems, there is now increasing clinical evidence for sex differences in incidence, morbidity, and mortality of lung diseases including allergic diseases (such as asthma), chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, as well as pulmonary hypertension. Whether such differences are inherent and/or whether sex steroids play a role in modulating these differences is currently under investigation. The purpose of this review is to define sex differences in lung structure/function under normal and specific disease states, with exploration of whether and how sex hormone signaling mechanisms may explain these clinical observations. Focusing on adult age groups, the review addresses the following: 1) inherent sex differences in lung anatomy and physiology; 2) the importance of certain time points in life such as puberty, pregnancy, menopause, and aging; 3) expression and signaling of sex steroid receptors under normal vs. disease states; 4) potential interplay between different sex steroids; 5) the question of whether sex steroids are beneficial or detrimental to the lung; and 6) the potential use of sex steroid signaling as biomarkers and therapeutic avenues in lung diseases. The importance of focusing on sex differences and sex steroids in the lung lies in the increasing incidence of lung diseases in women and the need to address lung diseases across the life span. PMID:22240244

Measuring and predicting prostate cancer related quality of life changes using EPIC for clinical practice.

PubMed

Chipman, Jonathan J; Sanda, Martin G; Dunn, Rodney L; Wei, John T; Litwin, Mark S; Crociani, Catrina M; Regan, Meredith M; Chang, Peter

2014-03-01

We expanded the clinical usefulness of EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) by evaluating its responsiveness to health related quality of life changes, defining the minimally important differences for an individual patient change in each domain and applying it to a sexual outcome prediction model. In 1,201 subjects from a previously described multicenter longitudinal cohort we modeled the EPIC-CP domain scores of each treatment group before treatment, and at short-term and long-term followup. We considered a posttreatment domain score change from pretreatment of 0.5 SD or greater clinically significant and p ≤ 0.01 statistically significant. We determined the domain minimally important differences using the pooled 0.5 SD of the 2, 6, 12 and 24-month posttreatment changes from pretreatment values. We then recalibrated an EPIC-CP based nomogram model predicting 2-year post-prostatectomy functional erection from that developed using EPIC-26. For each health related quality of life domain EPIC-CP was sensitive to similar posttreatment health related quality of life changes with time, as was observed using EPIC-26. The EPIC-CP minimally important differences in changes in the urinary incontinence, urinary irritation/obstruction, bowel, sexual and vitality/hormonal domains were 1.0, 1.3, 1.2, 1.6 and 1.0, respectively. The EPIC-CP based sexual prediction model performed well (AUC 0.76). It showed robust agreement with its EPIC-26 based counterpart with 10% or less predicted probability differences between models in 95% of individuals and a mean ± SD difference of 0.0 ± 0.05 across all individuals. EPIC-CP is responsive to health related quality of life changes during convalescence and it can be used to predict 2-year post-prostatectomy sexual outcomes. It can facilitate shared medical decision making and patient centered care. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Comparison of Milk Yield and Animal Health in Turkish Farms with Differing Stall Types and Resting Surfaces

PubMed Central

Kara, Nurcan Karslioglu; Galic, Askin; Koyuncu, Mehmet

2015-01-01

The current study was carried out to determine the influence of different resting surfaces and stall types on milk yield and animal health. Study was carried out in Bursa that is one of the most important cities of Turkey in terms of dairy production. Effects of resting surfaces and stall types on milk yield were found to be important. Also influence of different resting surfaces and stall types on lactation length was examined and found that rubber mats were different from the two other options. Relationships between different resting surfaces or stall types and health problems were examined and connection between stall type and repeat breeding (RB), dystocia, retained placenta and a connection between resting surface types and RB and clinical mastitis were found to be important. Considering their economic reflections, it can be said that results are quite important to the Turkish dairy industry. PMID:25557824

The Influence of Context on Residents' Evaluations: Effects of Priming on Clinical Judgment and Affect

ERIC Educational Resources Information Center

Teunissen, P. W.; Stapel, D. A.; Scheele, F.; Scherpbier, A. J. J. A.; Boor, K.; van Diemen-Steenvoorde, J. A. A. M.; van der Vleuten, C. P. M.

2009-01-01

Different lines of research have suggested that context is important in acting and learning in the clinical workplace. It is not clear how contextual information influences residents' constructions of the situations in which they participate. The category accessibility paradigm from social psychology appears to offer an interesting perspective for…

Students' Perception of Important Teaching Behaviors in Classroom and Clinical Environments of a Community College Nursing and Dental Hygiene Education Program

ERIC Educational Resources Information Center

Kimbrough-Walls, Vickie J.

2012-01-01

Student success is dependent on effective instruction. Yet, effective teaching is difficult to define and described differently by students, faculty, and administrators. Nursing and dental hygiene education programs require faculty to teach in both classroom and clinical environments. However, accreditation agencies for these programs mandate…

Characteristics and Thinking of External Application of Chinese Medicine

NASA Astrophysics Data System (ADS)

Li, Mengyan; Bai, Ming; Miao, Mingsan

2018-01-01

Chinese traditional medicine plays an important role in the clinical treatment of traditional Chinese medicine topical drugs in recent years with the increasing types of disease treatment is also not much extended, this paper reviews the application of clinical application of traditional Chinese medicine in recent years in different conditions, to provide reference for related research.

[Duration of treatment and oral administrad on of antibiotics in community acquired pneumonia].

PubMed

Bernal-Vargas, Mónica A; Cortés, Jorge A

2016-04-01

Community acquired pneumonia (CAP) is an important cause of morbidity and mortality around the world, with high treatment costs due to hospitalization and complications (adverse events due to medications, antibiotic resistance, healthcare associated infections, etc.). It has been proposed administration of short courses and early switch of intravenous administration to oral therapy to avoid costs and complications. There are recommendations about these topics in national and intemational guidelines, based on clinical trials which do not demónstrate diffe-rences in mortality and complications when there is an early change from intravenous administration to the oral route. There are no statistically significant differences in safety and resolution of the disease when short and long treatment schemes were compared. In this review we present the most important guidelines and clinical studies, taking into account the pharmacological differences between different medications. It is considered that early switch from intravenous to oral administration route and use of short cycles in CAP is safe and brings benefits to patients and institutions.

Hypokalemic periodic paralysis; two different genes responsible for similar clinical manifestations

PubMed Central

Kim, Hunmin; Hwang, Hee; Cheong, Hae Il

2011-01-01

Primary hypokalemic periodic paralysis (HOKPP) is an autosomal dominant disorder manifesting as recurrent periodic flaccid paralysis and concomitant hypokalemia. HOKPP is divided into type 1 and type 2 based on the causative gene. Although 2 different ion channels have been identified as the molecular genetic cause of HOKPP, the clinical manifestations between the 2 groups are similar. We report the cases of 2 patients with HOKPP who both presented with typical clinical manifestations, but with mutations in 2 different genes (CACNA1Sp.Arg528His and SCN4A p.Arg672His). Despite the similar clinical manifestations, there were differences in the response to acetazolamide treatment between certain genotypes of SCN4A mutations and CACNA1S mutations. We identified p.Arg672His in the SCN4A gene of patient 2 immediately after the first attack through a molecular genetic testing strategy. Molecular genetic diagnosis is important for genetic counseling and selecting preventive treatment. PMID:22253645

Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

PubMed

Kudrin, Alex; Knezevic, Ivana; Joung, Jeewon; Kang, Hye-Na

2015-01-01

The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects. Scientific principles from WHO Guidelines on SBPs were used as a basis for the exercise. Working groups consisted of regulators, manufacturers and academia. The following topics were discussed by the working groups: clinical criteria for biosimilarity, extrapolation approach and the overall regulatory decision making process. In order to determine typical pitfalls in the design of a SBP clinical programme and evaluate the gap of knowledge, amongst different industry and regulatory stakeholders on the appraisal of the data arising from SBP clinical studies, we have presented two fictional but realistic clinical case studies. The first case consists of the fictional development programme for an infliximab SBP candidate. The second case describes clinical studies proposed for a fictional rituximab SBP candidate. In the first scenario a highly similar quality profile has been taken forward into clinical studies whereas there was an important residual difference in functional attributes for the rituximab SBP candidate. These case studies were presented at the WHO implementation workshop for the WHO guidelines on evaluation of similar biotherapeutic products held in Seoul, Republic of Korea, in May 2014. The goal was to illustrate the interpretation of the clinical data arising from studies with SBP candidates and elicit knowledge gaps in clinical assessment. This paper reflects the outcome of the exercise and discussions held in Seoul and offers an analysis of the case studies as a learning opportunity on clinical development and evaluation of SBPs. Copyright © 2014 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Are There Clinical Implications of Racial Differences in HbA1c? A Difference, to Be a Difference, Must Make a Difference

PubMed Central

Selvin, Elizabeth

2016-01-01

Studies that have compared HbA1c levels by race have consistently demonstrated higher HbA1c levels in African Americans than in whites. These racial differences in HbA1c have not been explained by measured differences in glycemia, sociodemographic factors, clinical factors, access to care, or quality of care. Recently, a number of nonglycemic factors and several genetic polymorphisms that operate through nonglycemic mechanisms have been associated with HbA1c. Their distributions across racial groups and their impact on hemoglobin glycation need to be systematically explored. Thus, on the basis of evidence for racial differences in HbA1c, current clinical guidelines from the American Diabetes Association state: “It is important to take…race/ethnicity…into consideration when using the A1C to diagnose diabetes.” However, it is not clear from the guidelines how this recommendation might be actualized. So, the critical question is not whether racial differences in HbA1c exist between African Americans and whites; the important question is whether the observed differences in HbA1c level are clinically meaningful. Therefore, given the current controversy, we provide a Point-Counterpoint debate on this issue. In the preceding point narrative, Dr. Herman provides his argument that the failure to acknowledge that HbA1c might be a biased measure of average glycemia and an unwillingness to rigorously investigate this hypothesis will slow scientific progress and has the potential to do great harm. In the counterpoint narrative below, Dr. Selvin argues that there is no compelling evidence for racial differences in the validity of HbA1c as a measure of hyperglycemia and that race is a poor surrogate for differences in underlying causes of disease risk. —William T. Cefalu Editor in Chief, Diabetes Care PMID:27457637

Clinical Applications of Hallucinogens: A Review

PubMed Central

Garcia-Romeu, Albert; Kersgaard, Brennan; Addy, Peter H.

2016-01-01

Hallucinogens fall into several different classes, as broadly defined by pharmacological mechanism of action, and chemical structure. These include psychedelics, entactogens, dissociatives, and other atypical hallucinogens. Although these classes do not share a common primary mechanism of action, they do exhibit important similarities in their ability to occasion temporary but profound alterations of consciousness, involving acute changes in somatic, perceptual, cognitive, and affective processes. Such effects likely contribute to their recreational use. However, a growing body of evidence indicates that these drugs may have therapeutic applications beyond their potential for abuse. This review will present data on several classes of hallucinogens with a particular focus on psychedelics, entactogens, and dissociatives, for which clinical utility has been most extensively documented. Information on each class is presented in turn, tracing relevant historical insights, highlighting similarities and differences between the classes from the molecular to the behavioral level, and presenting the most up-to-date information on clinically oriented research with these substances, with important ramifications for their potential therapeutic value. PMID:27454674

Are You "Tilting at Windmills" or Undertaking a Valid Clinical Trial?

PubMed Central

Zariffa, Jose; Kramer, John L.K.

2011-01-01

In this review, several aspects surrounding the choice of a therapeutic intervention and the conduct of clinical trials are discussed. Some of the background for why human studies have evolved to their current state is also included. Specifically, the following questions have been addressed: 1) What criteria should be used to determine whether a scientific discovery or invention is worthy of translation to human application? 2) What recent scientific advance warrants a deeper understanding of clinical trials by everyone? 3) What are the different types and phases of a clinical trial? 4) What characteristics of a human disorder should be noted, tracked, or stratified for a clinical trial and what inclusion /exclusion criteria are important to enrolling appropriate trial subjects? 5) What are the different study designs that can be used in a clinical trial program? 6) What confounding factors can alter the accurate interpretation of clinical trial outcomes? 7) What are the success rates of clinical trials and what can we learn from previous clinical trials? 8) What are the essential principles for the conduct of valid clinical trials? PMID:21786433

How large must a treatment effect be before it matters to practitioners? An estimation method and demonstration.

PubMed

Miller, William R; Manuel, Jennifer Knapp

2008-09-01

Treatment research is sometimes criticised as lacking in clinical relevance, and one potential source of this friction is a disconnection between statistical significance and what clinicians regard to be a meaningful difference in outcomes. This report demonstrates a novel methodology for estimating what substance abuse practitioners regard to be clinically important differences. To illustrate the estimation method, we surveyed 50 substance abuse treatment providers participating in the National Institute on Drug Abuse (NIDA) Clinical Trials Network. Practitioners identified thresholds for clinically meaningful differences on nine common outcome variables, indicated the size of effect that would justify their learning a new treatment method and estimated current outcomes from their services. Clinicians judged a difference between two treatments to be meaningful if outcomes were improved by about 10 - 12 points on the percentage of patients totally abstaining, arrested for driving while intoxicated, employed or having abnormal liver enzymes. A 5 percentage-point reduction in patient mortality was regarded as clinically significant. On continuous outcome measures (such as percentage of days abstinent or drinks per drinking day), practitioners judged an outcome to be significant when it doubled or halved the base rate. When a new treatment meets such criteria, practitioners were interested in learning it. Effects that are statistically significant in clinical trials may be unimpressive to practitioners. Clinicians' judgements of meaningful differences can inform the powering of clinical trials.

Emerging souvenirs-clinical presentation of the returning traveller with imported arbovirus infections in Europe.

PubMed

Eckerle, I; Briciu, V T; Ergönül, Ö; Lupşe, M; Papa, A; Radulescu, A; Tsiodras, S; Tsitou, C; Drosten, C; Nussenblatt, V R; Reusken, C B; Sigfrid, L A; Beeching, N J

2018-03-01

Arboviruses are an emerging group of viruses that are causing increasing health concerns globally, including in Europe. Clinical presentation usually consists of a nonspecific febrile illness that may be accompanied by rash, arthralgia and arthritis, with or without neurological or haemorrhagic syndromes. The range of differential diagnoses of other infectious and noninfectious aetiologies is broad, presenting a challenge for physicians. While knowledge of the geographical distribution of pathogens and the current epidemiological situation, incubation periods, exposure risk factors and vaccination history can help guide the diagnostic approach, the nonspecific and variable clinical presentation can delay final diagnosis. This narrative review aims to summarize the main clinical and laboratory-based findings of the three most common imported arboviruses in Europe. Evidence is extracted from published literature and clinical expertise of European arbovirus experts. We present three cases that highlight similarities and differences between some of the most common travel-related arboviruses imported to Europe. These include a patient with chikungunya virus infection presenting in Greece, a case of dengue fever in Turkey and a travel-related case of Zika virus infection in Romania. Early diagnosis of travel-imported cases is important to reduce the risk of localized outbreaks of tropical arboviruses such as dengue and chikungunya and the risk of local transmission from body fluids or vertical transmission. Given the global relevance of arboviruses and the continuous risk of (re)emerging arbovirus events, clinicians should be aware of the clinical syndromes of arbovirus fevers and the potential pitfalls in diagnosis. Copyright © 2018. Published by Elsevier Ltd.

Quality assessment of clinical education services in teaching hospitals located in Kerman, Iran.

PubMed

Yazdi-Feyzabadi, Vahid; Gozashti, Mohammad Hossein; Komsari, Samane; Mohammadtaghizadeh, Sedigheh; Amiresmaili, Mohammadreza

2015-11-01

Clinical education is one of the most important components of the resource generation function of health systems, and it has a very important role in graduates' competency with respect to effective, practical education. This study aimed to assess the quality of clinical services in Kerman's teaching hospitals located in southeastern Iran. This cross-sectional study was conducted in 2011 on 303 medical students at different levels of medical education at Kerman's teaching hospitals. A modified SERVQUAL instrument was used to collect the data after its validity and reliability were checked. The data were analyzed by SPSS 18.0 using the paired t-test, Kruskal-Wallis, and post hoc tests, when appropriate. In all five dimensions of quality, gaps were observed between students' perceptions and expectations as follows: Assurance (mean = -1.18), Responsiveness (-1.56), Empathy (-1.4), Reliability (-1.27), and Tangibles (-1.21). There was a significant difference between the quality perceptions and expectations of the medical students (p < 0.001). A significant difference was observed between three educational levels, including externships, internships, and assistantships regarding the dimensions of the quality gaps (p < 0.001). The clinical services provided by teaching hospitals in the study did not meet the students' expectations at any of the three educational levels. As we precisely assessed the dimensions and items that had the higher quality gaps, it was apparent that, for most part, clinical education officials could improve the quality by designing interventions, which would not be very difficult to do.

Minimum clinically important differences in chronic pain vary considerable by baseline pain and methodological factors: systematic review of empirical studies.

PubMed

Frahm Olsen, Mette; Bjerre, Eik; Hansen, Maria Damkjær; Tendal, Britta; Hilden, Jørgen; Hróbjartsson, Asbjørn

2018-05-21

The minimum clinically important difference (MCID) is used to interpret the relevance of treatment effects, e.g., when developing clinical guidelines, evaluating trial results or planning sample sizes. There is currently no agreement on an appropriate MCID in chronic pain and little is known about which contextual factors cause variation. This is a systematic review. We searched PubMed, EMBASE, and Cochrane Library. Eligible studies determined MCID for chronic pain based on a one-dimensional pain scale, a patient-reported transition scale of perceived improvement, and either a mean change analysis (mean difference in pain among minimally improved patients) or a threshold analysis (pain reduction associated with best sensitivity and specificity for identifying minimally improved patients). Main results were descriptively summarized due to considerable heterogeneity, which were quantified using meta-analyses and explored using subgroup analyses and metaregression. We included 66 studies (31.254 patients). Median absolute MCID was 23 mm on a 0-100 mm scale (interquartile range [IQR] 12-39) and median relative MCID was 34% (IQR 22-45) among studies using the mean change approach. In both cases, heterogeneity was very high: absolute MCID I 2  = 99% and relative MCID I 2  = 96%. High variation was also seen among studies using the threshold approach: median absolute MCID was 20 mm (IQR 15-30) and relative MCID was 32% (IQR 15-41). Absolute MCID was strongly associated with baseline pain, explaining approximately two-thirds of the variation, and to a lesser degree with the operational definition of minimum pain relief and clinical condition. A total of 15 clinical and methodological factors were assessed as possible causes for variation in MCID. MCID for chronic pain relief vary considerably. Baseline pain is strongly associated with absolute, but not relative, measures. To a much lesser degree, MCID is also influenced by the operational definition of relevant pain relief and possibly by clinical condition. Explicit and conscientious reflections on the choice of an MCID are required when classifying effect sizes as clinically important or trivial. Copyright © 2018 Elsevier Inc. All rights reserved.

Osteoarthritis subpopulations and implications for clinical trial design

PubMed Central

2011-01-01

Treatment guidelines for osteoarthritis have stressed the need for research on clinical predictors of response to different treatments. However, identifying such clinical predictors of response is less easy than it seems, and there is not a given classification of osteoarthritis subpopulations. This review article highlights the key methodical issues when analyzing and designing clinical studies to detect important subgroups with respect to treatment effect. In addition, we discuss the main osteoarthritis subpopulations and give examples of how specific treatment effects in these subpopulations have been assessed. PMID:21470393

[How to prevent hazards and to reduce risk in clinical trials?].

PubMed

Czarkowski, Marek

2008-12-01

Different stakeholders involved in clinical trials are exposed to hazards related with this biomedical research. Beside clinical trials participants other important stakeholders are: investigators, sponsors, centers and clinical research organizations. Hazard prevention needs effective methods of hazard disclosure and analysis. A reduction of risks related with clinical trials is possible due to education, training, inspections, research discipline and penalties. Effective ways of hazard elimination or hazard reduction should be developed as well. Education and training should be offered to all stakeholders but their forms and contents should be adapted to different types of stakeholders. Direct control of the clinical trials should be held by stakeholders conducting clinical trials and outside inspections should be done by other institutions like clinical research organizations, research ethics committees and The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Serious oversight is an absence of any independent inspection during a phase of publication of clinical trial results. We should not accept any exception from the golden rule that results of all clinical trials must be published. Indemnity for damages is a popular way of compensation for clinical trials participants. Investigators, sponsors and centers should have valid liability insurance. Drastic measures for reduction of risks in clinical trials are different kinds of penalties. They should prevent participation of unreliable stakeholders and promote those who respect regulations and high ethical standards.

Optimizer convergence and local minima errors and their clinical importance

NASA Astrophysics Data System (ADS)

Jeraj, Robert; Wu, Chuan; Mackie, Thomas R.

2003-09-01

Two of the errors common in the inverse treatment planning optimization have been investigated. The first error is the optimizer convergence error, which appears because of non-perfect convergence to the global or local solution, usually caused by a non-zero stopping criterion. The second error is the local minima error, which occurs when the objective function is not convex and/or the feasible solution space is not convex. The magnitude of the errors, their relative importance in comparison to other errors as well as their clinical significance in terms of tumour control probability (TCP) and normal tissue complication probability (NTCP) were investigated. Two inherently different optimizers, a stochastic simulated annealing and deterministic gradient method were compared on a clinical example. It was found that for typical optimization the optimizer convergence errors are rather small, especially compared to other convergence errors, e.g., convergence errors due to inaccuracy of the current dose calculation algorithms. This indicates that stopping criteria could often be relaxed leading into optimization speed-ups. The local minima errors were also found to be relatively small and typically in the range of the dose calculation convergence errors. Even for the cases where significantly higher objective function scores were obtained the local minima errors were not significantly higher. Clinical evaluation of the optimizer convergence error showed good correlation between the convergence of the clinical TCP or NTCP measures and convergence of the physical dose distribution. On the other hand, the local minima errors resulted in significantly different TCP or NTCP values (up to a factor of 2) indicating clinical importance of the local minima produced by physical optimization.

Optimizer convergence and local minima errors and their clinical importance.

PubMed

Jeraj, Robert; Wu, Chuan; Mackie, Thomas R

2003-09-07

Two of the errors common in the inverse treatment planning optimization have been investigated. The first error is the optimizer convergence error, which appears because of non-perfect convergence to the global or local solution, usually caused by a non-zero stopping criterion. The second error is the local minima error, which occurs when the objective function is not convex and/or the feasible solution space is not convex. The magnitude of the errors, their relative importance in comparison to other errors as well as their clinical significance in terms of tumour control probability (TCP) and normal tissue complication probability (NTCP) were investigated. Two inherently different optimizers, a stochastic simulated annealing and deterministic gradient method were compared on a clinical example. It was found that for typical optimization the optimizer convergence errors are rather small, especially compared to other convergence errors, e.g., convergence errors due to inaccuracy of the current dose calculation algorithms. This indicates that stopping criteria could often be relaxed leading into optimization speed-ups. The local minima errors were also found to be relatively small and typically in the range of the dose calculation convergence errors. Even for the cases where significantly higher objective function scores were obtained the local minima errors were not significantly higher. Clinical evaluation of the optimizer convergence error showed good correlation between the convergence of the clinical TCP or NTCP measures and convergence of the physical dose distribution. On the other hand, the local minima errors resulted in significantly different TCP or NTCP values (up to a factor of 2) indicating clinical importance of the local minima produced by physical optimization.

Incidence and course of child malnutrition according to clinical or anthropometrical assessment: a longitudinal study from rural DR Congo

PubMed Central

2014-01-01

Background Longitudinal studies describing incidence and natural course of malnutrition are scarce. Studies defining malnutrition clinically [moderate clinical malnutrition (McM) marasmus, kwashiorkor] rather than anthropometrically are rare. Our aim was to address incidence and course of malnutrition among pre-schoolers and to compare patterns and course of clinically and anthropometrically defined malnutrition. Methods Using a historical, longitudinal study from Bwamanda, DR Congo, we studied incidence of clinical versus anthropometrical malnutrition in 5 657 preschool children followed 3-monthly during 15 months. Results Incidence rates were highest in the rainy season for all indices except McM. Incidence rates of McM and marasmus tended to be higher for boys than for girls in the dry season. Malnutrition rates increased from the 0–5 to the 6 – 11 months age category. McM and marasmus had in general a higher incidence at all ages than their anthropometrical counterparts, moderate and severe wasting. Shifts back to normal nutritional status within 3 months were more frequent for clinical than for anthropometrical malnutrition (62.2-80.3% compared to 3.4-66.4.5%). Only a minority of moderately stunted (30.9%) and severely stunted children (3.4%) shifted back to normal status. Alteration from severe to mild malnutrition was more characteristic for anthropometrically than for clinically defined malnutrition. Conclusions Our data on age distribution of incidence and course of malnutrition underline the importance of early life intervention to ward off malnutrition. In principle, looking at incidence may yield different findings from those obtained by looking at prevalence, since incidence and prevalence differ approximately differ by a factor “duration”. Our findings show the occurrence dynamics of general malnutrition, demonstrating that patterns can differ according to nutritional assessment method. They suggest the importance of applying a mix of clinical and anthropometric methods for assessing malnutrition instead of just one method. Functional validity of characterization of aspects of individual nutritional status by single anthropometric scores or by simple clinical classification remain issues for further investigation. PMID:24467733

Gender differences in liver disease and the drug-dose gender gap.

PubMed

Buzzetti, Elena; Parikh, Pathik M; Gerussi, Alessio; Tsochatzis, Emmanuel

2017-06-01

Although gender-based medicine is a relatively recent concept, it is now emerging as an important field of research, supported by the finding that many diseases manifest differently in men and women and therefore, might require a different treatment. Sex-related differences regarding the epidemiology, progression and treatment strategies of certain liver diseases have long been known, but most of the epidemiological and clinical trials still report results only about one sex, with consequent different rate of response and adverse reactions to treatment between men and women in clinical practice. This review reports the data found in the literature concerning the gender-related differences for the most representative hepatic diseases. Copyright © 2017 Elsevier Ltd. All rights reserved.

TCGA head Neck

Cancer.gov

Investigators with The Cancer Genome Atlas (TCGA) Research Network have discovered genomic differences – with potentially important clinical implications – in head and neck cancers caused by infection with the human papillomavirus (HPV).

Clinical resistance and decreased susceptibility in Streptococcus suis isolates from clinically healthy fattening pigs.

PubMed

Callens, Bénédicte F; Haesebrouck, Freddy; Maes, Dominiek; Butaye, Patrick; Dewulf, Jeroen; Boyen, Filip

2013-04-01

Streptococcus suis (S. suis) has often been reported as an important swine pathogen and is considered as a new emerging zoonotic agent. Consequently, it is important to be informed on its susceptibility to antimicrobial agents. In the current study, the Minimum Inhibitory Concentration (MIC) population distribution of nine antimicrobial agents has been determined for nasal S. suis strains, isolated from healthy pigs at the end of the fattening period from 50 closed or semiclosed pig herds. The aim of the study was to report resistance based on both clinical breakpoints (clinical resistance percentage) and epidemiological cutoff values (non-wild-type percentage). Non-wild-type percentages were high for tetracycline (98%), lincomycin (92%), tilmicosin (72%), erythromycin (70%), tylosin (66%), and low for florfenicol (0%) and enrofloxacin (0.3%). Clinical resistance percentages were high for tetracycline (95%), erythromycin (66%), tylosin (66%), and low for florfenicol (0.3%) and enrofloxacin (0.3%). For tiamulin, for which no clinical breakpoint is available, 57% of the isolates did not belong to the wild-type population. Clinical resistance and non-wild-type percentages differed substantially for penicillin. Only 1% of the tested S. suis strains was considered as clinically resistant, whereas 47% of the strains showed acquired resistance when epidemiological cutoff values were used. In conclusion, MIC values for penicillin are gradually increasing, compared to previous reports, although pigs infected with strains showing higher MICs may still respond to treatment with penicillin. The high rate of acquired resistance against tiamulin has not been reported before. Results from this study clearly demonstrate that the use of different interpretive criteria contributes to the extent of differences in reported antimicrobial resistance results. The early detection of small changes in the MIC population distribution of isolates, while clinical failure may not yet be observed, provides the opportunity to implement appropriate risk management steps.

The Physics and Mathematics of MRI

NASA Astrophysics Data System (ADS)

Ansorge, Richard; Graves, Martin

2016-10-01

Magnetic Resonance Imaging is a very important clinical imaging tool. It combines different fields of physics and engineering in a uniquely complex way. MRI is also surprisingly versatile, `pulse sequences' can be designed to yield many different types of contrast. This versatility is unique to MRI. This short book gives both an in depth account of the methods used for the operation and construction of modern MRI systems and also the principles of sequence design and many examples of applications. An important additional feature of this book is the detailed discussion of the mathematical principles used in building optimal MRI systems and for sequence design. The mathematical discussion is very suitable for undergraduates attending medical physics courses. It is also more complete than usually found in alternative books for physical scientists or more clinically orientated works.

Clinical protein science developments for patient monitoring in hospital central laboratories.

PubMed

Malm, Johan; Marko-Varga, György

2016-12-01

Patient care relies heavily on standardized tests performed in hospital laboratories, typically including clinical chemistry, pathology and microbiology. With the introduction of personalized medicine tremendous efforts have been made to identify new biomarkers of disease with various omics technologies, often including mass spectrometry. In order to validate new biomarkers and perform clinical studies high quality biobank samples are of key importance. In this editorial different aspects of mass spectrometry in future personalized medicine are discussed.

ε-Aminocaproic acid and clinical value in cardiac anesthesia.

PubMed

Raghunathan, Karthik; Connelly, Neil Roy; Kanter, Gary J

2011-02-01

The primary aim was to compare the "clinical value" of tranexamic acid (TXA) with ε-aminocaproic acid (EACA) when used for blood conservation during high-risk cardiac surgery. Data previously reported by the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study investigators were reanalyzed independently after appropriate statistical adjustment. The authors compared TXA with EACA for important primary and secondary outcomes and applied the "clinical value" equation to this comparison. BART, the largest blinded multicenter study on this topic to date, compared all 3 commonly used antifibrinolytics head-to-head in a randomized dose-equivalent fashion during high-risk cardiac surgery. Comparisons of TXA with EACA with application of the clinical value equation was not performed specifically by the BART investigators. One thousand five hundred fifty patients enrolled in 2 of the 3 arms of the BART study were included in the analysis (TXA, n= 770 and EACA, n = 780, with data reported by the investigators in the New England Journal of Medicine). The major finding was that there were no significant differences in overall safety and clinically important efficacy between TXA and EACA. Considering the substantial difference in costs and with the increasing volume of high-risk cardiac surgery, EACA has increased "clinical value" when compared with TXA. EACA should be the antifibrinolytic medication of choice for high-risk cardiac surgery. Copyright © 2011 Elsevier Inc. All rights reserved.

Congenital brain infections.

PubMed

Arbelaez, Andres; Restrepo, Feliza; Davila, Jorge; Castillo, Mauricio

2014-06-01

Pediatric congenital intracranial infections are a group of different and important entities that constitute a small percentage of all pediatric infections. The causal factors and clinical presentations are different in children compared with adults. They require early recognition because delay diagnosis and initiation of treatment may have catastrophic consequences. Despite improvements in prenatal screening, vaccine safety, and antibiotics, infections of the central nervous system remain an important cause of neurological disabilities worldwide. This article reviews the most common congenital infections and their imaging findings.

The potential role of the medial olivocochlear bundle in the generation of tinnitus: controversies and weaknesses in the existing clinical studies.

PubMed

Riga, Maria; Katotomichelakis, Michael; Danielides, Vasilios

2015-02-01

The physiology of the efferent cochlear innervation and the pathophysiology of tinnitus are 2 important but rather obscure chapters of neuro-otology. The possible interference of the medial olivocochlear bundle (MOCB) in the pathophysiology of tinnitus is not only a matter of strong controversy but also a field with possible important clinical and therapeutic implications. The aim of this study was to reveal the differences in study population, design, and methodology that may have attributed the conflicting results in the existing clinical trials. A review of the relevant literature published between January 1990 and June 2013 was conducted via the PubMed database (www.pubmed.org) with the search terms "tinnitus" and "otoacoustic emissions and suppression or efferent." Clinical studies on patients with additional pathologic abnormalities that may implicate the MOCB, such as hyperacousis or auditory neuropathy, were excluded. The 15 relevant studies were reviewed for critical differences in the recruitment of their study population and control group, as well as their methods of testing and evaluating the results. The different methods and study parameters are compared to each other. Factors known to attribute different MOCB responses, possibly responsible for the controversial results, are highlighted. The remarkable heterogeneity of the existing studies does not allow for safe conclusions. Insufficient knowledge on the physiology of the MOCB reflex seems to preclude the formation of a consensus on the optimal protocol for the evaluation of its function. Further research is definitely needed.

Trend of toxocariasis in Iran: a review on human and animal dimensions

PubMed Central

Zibaei, M.; Sadjjadi, S. M.

2017-01-01

One of the neglected soil and/or food-borne diseases with international public health importance is toxocariasis. Human cases are being increasingly reported from Asian, African, Oceania, European and the American countries. Hence, human toxocariasis (HT) is now considered as a major zoonosis with global and regional importance. In Iran, human and animal toxocariasis is an endemic disease with clinical and epidemiologic health problem aspects. Doubtless, understanding the epidemiology and the trend of this important parasitic disease and its affecting factors will provide the establishment of effective prevention and control programs. To better understand the trend of toxocariasis researches in Iran, this study was performed to analyze different aspects of this zoonotic disease including history, life cycle, species, human animals and environmental studies, diagnostic aspects and treatments to find out the gaps, including different aspects of clinical sings in human patients, new and specific recombinant antigens based on the native antigens, new diagnostic tools, especially rapid diagnostic tests, paratenic hosts status and new treatment procedures which is necessary to be investigated in the future studies on this important zoonotic disease. PMID:29387094

Antibacterial effect of bioactive glasses on clinically important anaerobic bacteria in vitro.

PubMed

Leppäranta, Outi; Vaahtio, Minna; Peltola, Timo; Zhang, Di; Hupa, Leena; Hupa, Mikko; Ylänen, Heimo; Salonen, Jukka I; Viljanen, Matti K; Eerola, Erkki

2008-02-01

Bioactive glasses (BAGs) of different compositions have been studied for decades for clinical use and they have found many dental and orthopaedic applications. Particulate BAGs have also been shown to have antibacterial properties. This large-scale study shows that two bioactive glass powders (S53P4 and 13-93) and a sol-gel derived material (CaPSiO II) have an antibacterial effect on 17 clinically important anaerobic bacterial species. All the materials tested demonstrated growth inhibition, although the concentration and time needed for the effect varied depending on the BAG. Glass S53P4 had a strong growth-inhibitory effect on all pathogens tested. Glass 13-93 and sol-gel derived material CaPSiO II showed moderate antibacterial properties.

Clinical characteristics of Staphylococcus epidermidis: a systematic review

PubMed Central

Namvar, Amirmorteza Ebrahimzadeh; Bastarahang, Sara; Abbasi, Niloufar; Ghehi, Ghazaleh Sheikhi; Farhadbakhtiarian, Sara; Arezi, Parastoo; Hosseini, Mahsa; Baravati, Sholeh Zaeemi; Jokar, Zahra; Chermahin, Sara Ganji

2014-01-01

Staphylococci are known as clustering Gram-positive cocci, nonmotile, non-spore forming facultatively anaerobic that classified in two main groups, coagulase-positive and coagulase-negative. Staphylococcus epidermidis with the highest percentage has the prominent role among coagulase-negative Staphylococci that is the most important reason of clinical infections. Due to various virulence factors and unique features, this microorganism is respected as a common cause of nosocomial infections. Because of potential ability in biofilm formation and colonization in different surfaces, also using of medical implant devices in immunocompromised and hospitalized patients the related infections have been increased. In recent decades the clinical importance and the emergence of methicillin-resistant Staphylococcus epidermidis strains have created many challenges in the treatment process. PMID:25285267

Clinical learning environments (actual and expected): perceptions of Iran University of Medical Sciences nursing students

PubMed Central

Bigdeli, Shoaleh; Pakpour, Vahid; Aalaa, Maryam; Shekarabi, Robabeh; Sanjari, Mahnaz; Haghani, Hamid; Mehrdad, Neda

2015-01-01

Background: Educational clinical environment has an important role in nursing students' learning. Any difference between actual and expected clinical environment will decrease nursing students’ interest in clinical environments and has a negative correlation with their clinical performance. Methods: This descriptive cross-sectional study is an attempt to compare nursing students' perception of the actual and expected status of clinical environments in medical-surgical wards. Participants of the study were 127 bachelor nursing students of Iran University of Medical Sciences in the internship period. Data gathering instruments were a demographic questionnaire (including sex, age, and grade point average), and the Clinical Learning Environment Inventory (CLEI) originally developed by Professor Chan (2001), in which its modified Farsi version (Actual and Preferred forms) consisting 42 items, 6 scales and 7 items per scale was used. Descriptive and inferential statistics (t-test, paired t-test, ANOVA) were used for data analysis through SPSS version 16. Results: The results indicated that there were significant differences between the preferred and actual form in all six scales. In other word, comparing with the actual form, the mean scores of all items in the preferred form were higher. The maximum mean difference was in innovation and the highest mean difference was in involvement scale. Conclusion: It is concluded that nursing students do not have a positive perception of their actual clinical teaching environment and this perception is significantly different from their perception of their expected environment. PMID:26034726

Chicken Coccidiosis in Central Java, Indonesia: A Recent Update.

PubMed

Hamid, Penny Humaidah; Kristianingrum, Yuli Purwandari; Wardhana, April Hari; Prastowo, Sigit; da Silva, Liliana Machado Ribeiro

2018-01-01

Avian coccidiosis is a huge problem worldwide. Heavily infected animals that show severe clinical signs and coccidiostat resistance are causing important economic losses. The present study aimed to update the recent cases of coccidiosis in Central Java, Indonesia, and to show the importance of the disease in the region. A total of 699 samples were obtained from different chicken breed. Different Eimeria species were detected in 175 individuals (25.04%). Three different groups of chicken breed were considered: local chicken (autochthonous chickens of Sentul and Jawa), commercial broiler, and layer. Broiler chickens showed the highest prevalence of infection (34%), followed by layer (26.26%) and local chickens (10.45%). Mild to severe clinical signs of avian coccidiosis were observed in 42% of the infected animals, while 58% of the infected animals showed no clinical signs other than low feed conversion rates. Seven different Eimeria species were identified: E. tenella was the most prevalent (43.3%), followed by E. maxima (26.3%), E. necatrix (15.7%), E. acervulina (8%), E. praecox (3.1%), E. mitis (2.2%), and E. brunetti (1.3%). Coinfections with several Eimeria species were diagnosed. With this study we found massive usage of coccidiostat in the region even though its usage cannot guarantee coccidiosis-free chicken production.

Genetic Factors in Systemic Lupus Erythematosus: Contribution to Disease Phenotype

PubMed Central

Ceccarelli, Fulvia; Perricone, Carlo; Borgiani, Paola; Ciccacci, Cinzia; Rufini, Sara; Cipriano, Enrica; Alessandri, Cristiano; Spinelli, Francesca Romana; Sili Scavalli, Antonio; Novelli, Giuseppe; Valesini, Guido; Conti, Fabrizio

2015-01-01

Genetic factors exert an important role in determining Systemic Lupus Erythematosus (SLE) susceptibility, interplaying with environmental factors. Several genetic studies in various SLE populations have identified numerous susceptibility loci. From a clinical point of view, SLE is characterized by a great heterogeneity in terms of clinical and laboratory manifestations. As widely demonstrated, specific laboratory features are associated with clinical disease subset, with different severity degree. Similarly, in the last years, an association between specific phenotypes and genetic variants has been identified, allowing the possibility to elucidate different mechanisms and pathways accountable for disease manifestations. However, except for Lupus Nephritis (LN), no studies have been designed to identify the genetic variants associated with the development of different phenotypes. In this review, we will report data currently known about this specific association. PMID:26798662

Validation of Different Combination of Three Reversing Half-Hitches Alternating Posts (RHAPs) Effects on Arthroscopic Knot Integrity.

PubMed

Chong, Alexander Cm; Prohaska, Daniel J; Bye, Brian P

2017-05-01

With arthroscopic techniques being used, the importance of knot tying has been examined. Previous literature has examined the use of reversing half-hitches on alternating posts (RHAPs) on knot security. Separately, there has been research regarding different suture materials commonly used in the operating room. The specific aim of this study was to validate the effect of different stacked half-hitch configuration and different braided suture materials on arthroscopic knot integrity. Three different suture materials tied with five different RHAPs in arthroscopic knots were compared. A single load-to-failure test was performed and the mean ultimate clinical failure load was obtained. Significant knot holding strength improvement was found when one half-hitch was reversed as compared to baseline knot. When two of the half-hitches were reversed, there was a greater improvement with all knots having a mean ultimate clinical failure load greater than 150 newtons (N). Comparison of the suture materials demonstrated a higher mean ultimate clinical failure load when Force Fiber ® was used and at least one half-hitch was reversed. Knots tied with either Force Fiber ® or Orthocord ® showed 0% chance of knot slippage while knots tied with FiberWire ® or braided fishing line had about 10 and 30% knot slippage chances, respectively. A significant effect was observed in regards to both stacked half-hitch configuration and suture materials used on knot loop and knot security. Caution should be used with tying three RHAPs in arthroscopic surgery, particularly with a standard knot pusher and arthroscopic cannulas. The findings of this study indicated the importance of three RHAPs in performing arthroscopic knot tying and provided evidence regarding discrepancies of maximum clinical failure loads observed between orthopaedic surgeons, thereby leading to better surgical outcomes in the future.

A Phenomenological Study of the Office Environments of Clinical Social Workers.

PubMed

Jones, Jamie K

2018-01-01

The purpose of this study was to explore the meaning and uses of the office space among licensed clinical social workers in private practice. Previous research suggests the importance of the office space in clinical practice in regard to therapeutic alliance, client behavior, and the well-being of the therapist. However, therapist offices contain much variation in design. This study looked further into specifically how the therapy room is important through the perspective of the licensed clinical social workers in order to identify common themes. Seven licensed clinical social workers in private psychotherapy practice were interviewed in their offices. Phenomenological research methods were used to explore and analyze their experiences. While the offices contained many physical differences, the intentions behind the designs were similar. Three themes emerged regarding how participants used and designed their spaces. First, participants used their offices to provide care for clients and themselves. Second, participants used their spaces to communicate therapeutic messages and to reveal and/or conceal aspects of themselves. Third, participants also used their space in direct practice. This phenomenological study provided insight into the importance and use of the psychotherapy office space. These findings may be helpful for therapists designing or redesigning their own practice spaces.

Do Men and Women Walk Differently? A Review and Meta-Analysis of Sex Difference in Non-Pathological Gait Kinematics

DTIC Science & Technology

2014-01-01

Physiotherapy , 2011. 97(3): 182-189. 27. Al-Obaidi, S., et al., Basic gait parameters: a comparison of reference data for normal subjects 20 to 29...et al., Importance of correcting for individual differences in the clinical diagnosis of gait disorders. Physiotherapy , 2012. 98(4): 320-324. 71

Clinical Summarization Capabilities of Commercially-available and Internally-developed Electronic Health Records

PubMed Central

Laxmisan, A.; McCoy, A.B.; Wright, A.; Sittig, D.F.

2012-01-01

Objective Clinical summarization, the process by which relevant patient information is electronically summarized and presented at the point of care, is of increasing importance given the increasing volume of clinical data in electronic health record systems (EHRs). There is a paucity of research on electronic clinical summarization, including the capabilities of currently available EHR systems. Methods We compared different aspects of general clinical summary screens used in twelve different EHR systems using a previously described conceptual model: AORTIS (Aggregation, Organization, Reduction, Interpretation and Synthesis). Results We found a wide variation in the EHRs’ summarization capabilities: all systems were capable of simple aggregation and organization of limited clinical content, but only one demonstrated an ability to synthesize information from the data. Conclusion Improvement of the clinical summary screen functionality for currently available EHRs is necessary. Further research should identify strategies and methods for creating easy to use, well-designed clinical summary screens that aggregate, organize and reduce all pertinent patient information as well as provide clinical interpretations and synthesis as required. PMID:22468161

The validity of the SF-12 and SF-6D instruments in people living with HIV/AIDS in Kenya.

PubMed

Patel, Anik R; Lester, Richard T; Marra, Carlo A; van der Kop, Mia L; Ritvo, Paul; Engel, Lidia; Karanja, Sarah; Lynd, Larry D

2017-07-17

Health-related quality of life (HRQoL) and health state utility value (HSUV) measurements are vital components of healthcare clinical and economic evaluations. Accurate measurement of HSUV and HRQoL require validated instruments. The 12-item Short-Form Health Survey (SF-12) is one of few instruments that can evaluate both HRQoL and HSUV, but its validity has not been assessed in people living with HIV/AIDS (PLWHA) in east Africa, where the burden of HIV is high. This cross-sectional study used baseline data from a randomized trial involving PLWHA in Kenya. Data included responses from a translated and adapted SF-12 survey as well as key demographic and clinical data. Construct validity of the survey was examined by testing the SF-12's ability to distinguish between groups known in advance to have differences in their health based on their disease severity. We classified disease severity based on established definitions from the US Center for Disease Control (CDC) and WHO, as well as a previously studied viral load threshold. T-tests and ANOVA were used to test for differences in HRQoL and HSUV scores. Area under the receive operator curve (AUC) was used to test the discriminative ability of the HRQoL and HSUV instruments. Differences in physical component scores met the minimum clinically important difference among participants with more advanced HIV when defined by CD4 count (4.3 units) and WHO criteria (compared to stage 1, stages 2, 3 and 4 were 2.0, 7.2 and 9.8 units lower respectively). Mental score differences met the minimum clinically important difference between WHO stage 1 and stage 4 patients (4.4). Differences in the HSUV were statistically lower in more advanced HIV by all three definitions of severity. The AUC showed poor to weak discriminatory ability in most analyses, but had fair discriminatory ability between WHO clinical stage 1 and clinical stage 4 individuals (AUC = 0.71). Our findings suggest that the Kiswahili translated and adapted version of the SF-12 could be used as an assessment tool for physical health, mental health and HSUV for Kiswahili-speaking PLHWA. Clinical trials.gov identifier: NCT00830622 . Registered 26 January 2009.

No difference between fixed- and mobile-bearing total knee arthroplasty in activities of daily living and pain: a randomized clinical trial.

PubMed

Amaro, Joicemar Tarouco; Arliani, Gustavo Gonçalves; Astur, Diego Costa; Debieux, Pedro; Kaleka, Camila Cohen; Cohen, Moises

2017-06-01

Until now, there are no definitive conclusions regarding functional differences related to middle- and long-term everyday activities and patient pain following implantation of mobile- and fixed-platform tibial prostheses. The aim of this study was to determine whether there are middle-term differences in knee function and pain in patients undergoing fixed- and mobile-bearing total knee arthroplasty (TKA). Eligible patients were randomized into two groups: the first group received TKA implantation with a fixed tibial platform (group A); the second group received TKA with a mobile tibial platform (group B). Patients were followed up (2 years), and their symptoms and limitations in daily living activities were evaluated using the Knee Outcome Survey-Activities of Daily Living Scale (ADLS), in addition to pain evaluation assessed using the pain visual analogue scale (VAS). There were no significant differences in function and symptoms in the ADLS and VAS between the study groups. The type of platform used in TKA (fixed vs. mobile) does not change the symptoms, function or pain of patients 2 years post-surgery. Although mobile TKAs may have better short-term results, at medium- and long-term follow-up they do not present important clinical differences compared with fixed-platform TKAs. This information is important so that surgeons can choose the most suitable implant for each patient. Randomized clinical trial, Level I.

Sub-clinical assessment of atopic dermatitis severity using angiographic optical coherence tomography

PubMed Central

Byers, Robert A.; Maiti, Raman; Danby, Simon G.; Pang, Elaine J.; Mitchell, Bethany; Carré, Matt J.; Lewis, Roger; Cork, Michael J.; Matcher, Stephen J.

2018-01-01

Measurement of sub-clinical atopic dermatitis (AD) is important for determining how long therapies should be continued after clinical clearance of visible AD lesions. An important biomarker of sub-clinical AD is epidermal hypertrophy, the structural measures of which often make optical coherence tomography (OCT) challenging due to the lack of a clearly delineated dermal-epidermal junction in AD patients. Alternatively, angiographic OCT measurements of vascular depth and morphology may represent a robust biomarker for quantifying the severity of clinical and sub-clinical AD. To investigate this, angiographic data sets were acquired from 32 patients with a range of AD severities. Deeper vascular layers within skin were found to correlate with increasing clinical severity. Furthermore, for AD patients exhibiting no clinical symptoms, the superficial plexus depth was found to be significantly deeper than healthy patients at both the elbow (p = 0.04) and knee (p<0.001), suggesting that sub-clinical changes in severity can be detected. Furthermore, the morphology of vessels appeared altered in patients with severe AD, with significantly different vessel diameter, length, density and fractal dimension. These metrics provide valuable insight into the sub-clinical severity of the condition, allowing the effects of treatments to be monitored past the point of clinical remission. PMID:29675335

Fermentation products in the cystic fibrosis airways induce aggregation and dormancy-associated expression profiles in a CF clinical isolate of Pseudomonas aeruginosa.

PubMed

Phan, Joann; Gallagher, Tara; Oliver, Andrew; England, Whitney E; Whiteson, Katrine

2018-05-01

Pseudomonas aeruginosa is a well-known dominant opportunistic pathogen in cystic fibrosis (CF) with a wide range of metabolic capacities. However, P. aeruginosa does not colonize the airways alone, and benefits from the metabolic products of neighboring cells-especially volatile molecules that can travel between different parts of the airways easily. Here, we present a study that investigates the metabolic, gene expression profiles and phenotypic responses of a P. aeruginosa clinical isolate to fermentation products lactic acid and 2,3-butanediol, metabolites that are produced by facultative anaerobic members of the CF polymicrobial community and potential biomarkers of disease progression. Although previous studies have successfully investigated the metabolic and transcriptional profiles of P. aeruginosa, most have used common lab reference strains that may differ in important ways from clinical isolates. Using transcriptomics and metabolomics with gas chromatography time of flight mass spectrometry, we observe that fermentation products induce pyocyanin production along with the expression of genes involved in P. aeruginosa amino acid utilization, dormancy and aggregative or biofilm modes of growth. These findings have important implications for how interactions within the diverse CF microbial community influence microbial physiology, with potential clinical consequences.

Pre-analytical and analytical aspects affecting clinical reliability of plasma glucose results.

PubMed

Pasqualetti, Sara; Braga, Federica; Panteghini, Mauro

2017-07-01

The measurement of plasma glucose (PG) plays a central role in recognizing disturbances in carbohydrate metabolism, with established decision limits that are globally accepted. This requires that PG results are reliable and unequivocally valid no matter where they are obtained. To control the pre-analytical variability of PG and prevent in vitro glycolysis, the use of citrate as rapidly effective glycolysis inhibitor has been proposed. However, the commercial availability of several tubes with studies showing different performance has created confusion among users. Moreover, and more importantly, studies have shown that tubes promptly inhibiting glycolysis give PG results that are significantly higher than tubes containing sodium fluoride only, used in the majority of studies generating the current PG cut-points, with a different clinical classification of subjects. From the analytical point of view, to be equivalent among different measuring systems, PG results should be traceable to a recognized higher-order reference via the implementation of an unbroken metrological hierarchy. In doing this, it is important that manufacturers of measuring systems consider the uncertainty accumulated through the different steps of the selected traceability chain. In particular, PG results should fulfil analytical performance specifications defined to fit the intended clinical application. Since PG has tight homeostatic control, its biological variability may be used to define these limits. Alternatively, given the central diagnostic role of the analyte, an outcome model showing the impact of analytical performance of test on clinical classifications of subjects can be used. Using these specifications, performance assessment studies employing commutable control materials with values assigned by reference procedure have shown that the quality of PG measurements is often far from desirable and that problems are exacerbated using point-of-care devices. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

A look at 15 years of planar thallium-201 imaging

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

Kaul, S.

1989-09-01

Extensive experience has been accumulated over the past 15 years regarding planar thallium-201 imaging. Quantitation of technically superior images provides a high sensitivity and specificity for the detection of CAD. In addition, planar thallium-201 images provide very important prognostic information in different clinical situations. Although single photon emission computerized tomography offers potential theoretical advantages over planar imaging, because of the problems involved in reconstruction, specifically the creation of artifacts, it may not be the ideal imaging modality in all situations. Good quality planar thallium-201 imaging still has an important role in clinical cardiology today. 144 references.

Listening to a patient: An exploratory experimental investigation into the effects of vocalization and therapist gender on interpreting clinical material.

PubMed

Dauphin, Barry; Halverson, Stacey; Pouliot, Sarah; Slowik, Linda

2018-01-01

Carefully listening to the patient is of paramount importance for psychoanalysis and psychoanalytic psychotherapy. The present study explored whether patient vocalization as well as the gender of the analyst play significant roles in clinical listening. Fifty-one psychoanalysts and psychoanalytic therapists were randomly assigned to listen to one of two dramatized psychoanalytic sessions. The content of the sessions was the same for both versions, but the sessions were dramatized differently. Some differences emerged between the versions, especially on ratings of reality testing, impulse control, pressured speech, patient was confusing, and awareness of imagery. Furthermore, differences emerged between male and female analysts in terms of ratings of intervention strategies and countertransference reactions to the patient material. Session version and gender affect different ratings. Implications of the findings are discussed as is the utility of using more ecologically valid material in conducting empirical research into clinical judgment.

Minimal clinically important difference of the Modified Fatigue Impact Scale in Parkinson's disease.

PubMed

Kluger, Benzi M; Garimella, Sanjana; Garvan, Cynthia

2017-10-01

Fatigue is a common and debilitating symptom of Parkinson's disease (PD) with no evidence-based treatments. While several fatigue scales are partially validated in PD the minimal clinically important difference (MCID) is unknown for any scale but is an important psychometric value to design and interpret therapeutic trials. We thus sought to determine the MCID for the Modified Fatigue Impact Scale (MFIS). This is a secondary data analysis from 94 PD participants in an acupuncture trial for PD fatigue. Standard psychometric approaches were used to establish validity and an anchor-based approach was used to determine the MCID. The MFIS demonstrated good concurrent validity with other outcome measures and high internal consistency. MCIDs values were found to be 13.8, 6.8 and 6.2 for the MFIS total, MFIS cognitive, and MFIS physical subscores respectively. The MFIS is a valid multidimensional measure of fatigue in PD with demonstrable MCID. Copyright © 2017 Elsevier Ltd. All rights reserved.

Myositis-specific autoantibodies: an important tool to support diagnosis of myositis.

PubMed

Betteridge, Z; McHugh, N

2016-07-01

The idiopathic inflammatory myopathies are characterized by muscle weakness, skin disease and internal organ involvement. Autoimmunity is known to have a role in myositis pathogenesis, and myositis-specific autoantibodies, targeting important intracellular proteins, are regarded as key biomarkers aiding in the diagnosis of patients. In recent years, a number of novel myositis autoantibodies including anti-TIF1, anti-NXP2, anti-MDA5, anti-SAE, anti-HMGCR and anti-cN1A have been identified in both adult and juvenile patients. These autoantibodies correlate with distinct clinical manifestations and importantly are found in inclusion body, statin-induced, clinically amyopathic and juvenile groups of myositis patients, previously believed to be mainly autoantibody negative. In this review, we will describe the main myositis-specific and myositis-associated autoantibodies and their frequencies and clinical associations across different ages and ethnic groups. We will also discuss preliminary studies investigating correlations between specific myositis autoantibody titres and clinical markers of disease course, collectively demonstrating the utility of myositis autoantibodies as both diagnostic and prognostic markers of disease. © 2015 The Association for the Publication of the Journal of Internal Medicine.

Worldwide Distribution of Cytochrome P450 Alleles: A Meta-analysis of Population-scale Sequencing Projects.

PubMed

Zhou, Y; Ingelman-Sundberg, M; Lauschke, V M

2017-10-01

Genetic polymorphisms in cytochrome P450 (CYP) genes can result in altered metabolic activity toward a plethora of clinically important medications. Thus, single nucleotide variants and copy number variations in CYP genes are major determinants of drug pharmacokinetics and toxicity and constitute pharmacogenetic biomarkers for drug dosing, efficacy, and safety. Strikingly, the distribution of CYP alleles differs considerably between populations with important implications for personalized drug therapy and healthcare programs. To provide a global distribution map of CYP alleles with clinical importance, we integrated whole-genome and exome sequencing data from 56,945 unrelated individuals of five major human populations. By combining this dataset with population-specific linkage information, we derive the frequencies of 176 CYP haplotypes, providing an extensive resource for major genetic determinants of drug metabolism. Furthermore, we aggregated this dataset into spectra of predicted functional variability in the respective populations and discuss the implications for population-adjusted pharmacological treatment strategies. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Clinical and scientific importance of source control in abdominal infections: summary of a symposium

PubMed Central

Bohnen, John M.A.; Marshall, John C.; Fry, Donald E.; Johnson, Steven B.; Solomkin, Joseph S.

1999-01-01

In May 1997, a panel of surgeon-investigators met to discuss the clinical importance and research implications of controlling the source of abdominal infections. It was concluded that source control is critical to therapeutic success and that antimicrobial therapy and other adjunctive interventions will fail if the source of infection is not controlled by resection, exteriorization or other means. The panelists presented different definitions of source control, depending on the scientific purpose of the definition. All participants agreed that failure to consider the adequacy of source control of infection has limited the value of most clinical trials of therapeutic anti-infective agents. Besides recognizing source control as an essential goal of patient care, the panelists emphasized the need for further investigative work to define, record and stratify the adequacy of source control in clinical trials of therapeutic agents for abdominal infections. PMID:10223073

Evidence-based medicine in daily surgical decision making: a survey-based comparison between the UK and Germany.

PubMed

Schnitzbauer, Andreas A; Proneth, Andrea; Pengel, Liset; Ansorg, Jörg; Anthuber, Matthias; Bechstein, Wolf O; Schlitt, Hans J; Geissler, Edward K

2015-01-01

Evidence-based medicine (EbM) is a vital part of reasonable and conclusive decision making for clinicians in daily clinical work. To analyze the knowledge and the attitude of surgeons towards EbM, a survey was performed in the UK and Germany. A web-based questionnaire was distributed via mailing lists from the Royal College of Surgeons of England (RCSE) and the Berufsverband Deutscher Chirurgen (BDC). Our primary aim was to get information about knowledge of EbM amongst German and British surgeons. A total of 549 individuals opened the questionnaire, but only 198 questionnaires were complete and valid for analysis. In total, 40,000 recipients were approached via the mailing lists of the BDC and RCSE. The response rate was equally low in both countries. On a scale from 1 (unimportant) to 10 (very important), all participants rated EbM as very important for daily clinical decision making (7.3 ± 1.9) as well as for patients (7.8 ± 1.9) and the national health system (7.8 ± 1.9). On a scale from 1 (unimportant) to 5 (very important), systematic reviews (4.6 ± 0.6) and randomized controlled trials (4.6 ± 0.6) were identified as the highest levels of study designs to enhance evidence in medicine. British surgeons considered EbM to be more important in daily clinical work when compared to data from German surgeons (7.9 ± 1.6 vs. 6.7 ± 2.1, p < 0.001). Subgroup analysis showed different results in some categories; however, a pattern to explain the differences was not evident. Personal requirements expressed in a free text field emphasized the results and reflected concerns such as broad unwillingness and lack of interdisciplinary approaches for patients (n = 59: 25 in the UK and 34 in Germany). The overall results show that EbM is believed to be important by surgeons in the UK and Germany. However, perception of EbM in the respective health system (UK vs. Germany) may be different. Nonetheless, EbM is an important tool to navigate through daily clinical problems although a discrepancy between the knowledge of theoretical abstract terms and difficulties in implementing EbM in daily clinical work has been detected. The provision of infrastructure, courses and structured education as a permanent instrument will advance the knowledge, application and improvement of EbM in the future. © 2014 S. Karger AG, Basel.

Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials.

PubMed

Keefe, Richard S E; Kraemer, Helena C; Epstein, Robert S; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P; McNulty, James; Reed, Shelby D; Sanchez, Juan; Leon, Andrew C

2013-05-01

This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials.

Systematic Review of Bilateral Independent Periodic Discharges Written for Topical Journal Subject on Periodic Discharges.

PubMed

Freund, Brin; Kaplan, Peter W

2018-05-01

Periodic discharges (PDs) are EEG patterns that may have important clinical and prognostic implications. There are different subtypes of PDs that are delineated by their location, and each type may have different meaning regarding prognosis and clinical associations. Bilateral independent PDs are a subtype that have not been analyzed recently and remain poorly understood. In this article, we systematically review the literature to better describe bilateral independent PDs regarding underlying neuropathology, neuroimaging, and neuroexamination correlates, seizure incidence, EEG characteristics, their comparison with other PD subtypes, and prognostic meaning.

A comparative review of clinical governance arrangements in the UK.

PubMed

Pridmore, Julia Ann; Gammon, John

This article provides a comparative review of the interpretation and implementation of clinical governance frameworks within the four home countries of the UK--England, Northern Ireland, Scotland and Wales. Clinical governance has become one of most significant and important concepts in modern health care. The article considers the policy background and the many definitions of clinical governance, but specifically compares the various strategic and operational approaches to delivery of clinical governance in different parts of the UK. It is suggested that these variations in approach, by each of the four UK countries, can lead to confusion for healthcare professionals in trying to understand, implement and monitor elements of clinical governance in practice.

Cultural differences in the development and characteristics of depression.

PubMed

Juhasz, Gabriella; Eszlari, Nora; Pap, Dorottya; Gonda, Xenia

2012-12-01

Depression is a highly prevalent mental illness with increasing burden for the patients, their families and society as well. In spite of its increasing importance, we still do not have complete understanding either of the phenomenology or the etiopathological background of depression, and cross-country, cross-ethnic and cross-cultural differences in the prevalence and symptomatic manifestation of depression further obscure this picture. Culturally-related features of depressive illness are gaining more importance in clinical practice with the increasing migration trends worldwide. In spite of the differences replicated in multiple studies, no exhaustive explanations are offered so far. In the present paper we describe the most consistently replicated findings concerning the most important cross-national differences in the rates and characteristics of depression with a short comment on possible background factors.

Healthcare in the New Vietnam: comparing patients' satisfaction with outpatient care in a traditional neighborhood clinic and a new, western-style clinic in Ho Chi Minh City.

PubMed

Tat, Sonny; Barr, Donald

2006-03-01

As Vietnam opens its economy to privatization, its system of healthcare will face a series of crucial tests. Vietnam's system of private healthcare--once comprised only of individual physicians holding clinic hours in their homes--has come to also include larger customer-oriented clinics based on an American business model. As the two models compete in the expanding private market, it becomes increasingly important to understand patients' perceptions of the alternative models of care. This study reports on interviews with 194 patients in two different types of private-sector clinics in Vietnam: a western-style clinic and a traditional style, after-hours clinic. In bivariate and multivariate analyses, we found that patients at the western style clinic reported both higher expectations of the facility and higher satisfaction with many aspects of care than patients at the after-hours clinic. These different perceptions appear to be based on the interpersonal manner of the physician seen and the clinic's delivery methods rather than perceptions of the physician's technical skill and method of treatment. These findings were unaffected by the ethnicity of physician seen. These findings suggest that patients in Vietnam recognize and prefer more customer-oriented care and amenities, regardless of physician ethnicity and perceive no significant differences in technical skill between the private delivery models.

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees.

PubMed

Segarra, Ignacio; Modamio, Pilar; Fernández, Cecilia; Mariño, Eduardo L

2017-01-01

The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug-drug interactions (DDI) to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs) and Research Ethics Committees (RECs). We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies.

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

PubMed Central

Segarra, Ignacio; Modamio, Pilar; Fernández, Cecilia; Mariño, Eduardo L.

2017-01-01

The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug–drug interactions (DDI) to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs) and Research Ethics Committees (RECs). We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies. PMID:28785221

Emollient product design: objective measurements of formulation structure, texture and performance, and subjective assessments of user acceptability.

PubMed

Antonijević, M D; Owusu-Ware, S; Sanchon-Lopez, B

2018-06-01

The choice of prescribed emollients is usually based on cost and patient preference. Differences in formulations can affect user acceptability. To compare the physical performance, user acceptability and various product design features of two emollient gels that are prescribed in the UK and alleged to be therapeutically interchangeable because their formulations are described as having the same contents of oily ingredients. We found that here are in fact significant measurable differences between the structure and performance of the two formulations, which materially affect their user acceptability. These differences are attributed to the use of different types of gelling agents and other ingredients of differing grades/quality and concentrations, and probably due to the formulations being made by different manufacturing processes. We also identified other product design features that are important to user appeal, including the type of container in which the formulations are presented, the type of dispensing devices provided, and the nature and form of the supplied user instructions. Patients and prescribers should be aware that there can be important differences in performance and user appeal between emollients, even between products that, superficially, may appear to be very similar. These important performance aspects should be characterized for new emollient introductions to encourage better informed product selection. © 2018 The Authors. Clinical and Experimental Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists, North American Clinical Dermatologic Society and St Johns Dermatological Society.

Clinical audit, a valuable tool to improve quality of care: General methodology and applications in nephrology

PubMed Central

Esposito, Pasquale; Dal Canton, Antonio

2014-01-01

Evaluation and improvement of quality of care provided to the patients are of crucial importance in the daily clinical practice and in the health policy planning and financing. Different tools have been developed, including incident analysis, health technology assessment and clinical audit. The clinical audit consist of measuring a clinical outcome or a process, against well-defined standards set on the principles of evidence-based medicine in order to identify the changes needed to improve the quality of care. In particular, patients suffering from chronic renal diseases, present many problems that have been set as topics for clinical audit projects, such as hypertension, anaemia and mineral metabolism management. Although the results of these studies have been encouraging, demonstrating the effectiveness of audit, overall the present evidence is not clearly in favour of clinical audit. These findings call attention to the need to further studies to validate this methodology in different operating scenarios. This review examines the principle of clinical audit, focusing on experiences performed in nephrology settings. PMID:25374819

Perceived levels of frustration during clinical situations in athletic training students.

PubMed

Heinerichs, Scott; Curtis, Neil; Gardiner-Shires, Alison

2014-01-01

Athletic training students (ATSs) are involved in various situations during the clinical experience that may cause them to express levels of frustration. Understanding levels of frustration in ATSs is important because frustration can affect student learning, and the clinical experience is critical to their development as professionals. To explore perceived levels of frustration in ATSs during clinical situations and to determine if those perceptions differ based on sex. Cross-sectional study with a survey instrument. A total of 14 of 19 professional, undergraduate athletic training programs accredited by the Commission on Accreditation of Athletic Training Education in Pennsylvania. Of a possible 438 athletic training students, 318 (72.6%) completed the survey. The Athletic Training Student Frustration Inventory was developed and administered. The survey gathered demographic information and included 24 Likert-scale items centering on situations associated with the clinical experience. Descriptive statistics were computed on all items. The Mann-Whitney U was used to evaluate differences between male and female students. A higher level of frustration was perceived during the following clinical situations: lack of respect by student-athletes and coaching staffs, the demands of the clinical experience, inability of ATSs to perform or remember skills, and ATSs not having the opportunity to apply their skills daily. Higher levels of frustration were perceived in female than male ATSs in several areas. Understanding student frustration during clinical situations is important to better appreciate the clinical education experience. Low levels of this emotion are expected; however, when higher levels exist, learning can be affected. Whereas we cannot eliminate student frustrations, athletic training programs and preceptors need to be aware of this emotion in order to create an environment that is more conducive to learning.

Clostridium Perfringens a-Toxin and NetB Toxin Antibodies and their possible role in protection against Necrotic Enteritis and Gangrenous Dermatitis in broiler chickens

USDA-ARS?s Scientific Manuscript database

Necrotic enteritis (NE) and gangrenous dermatitis (GD) are important infectious diseases of poultry. Although NE and GD share a common pathogen, Clostridium perfringens, they differ in other important aspects, such as clinical signs, pathologic symptoms, and age of onset. The primary virulence facto...

Clinical differences among nonsteroidal antiinflammatory drugs: implications for therapeutic substitution in ambulatory patients.

PubMed

Levy, R A; Smith, D L

1989-01-01

The practice of therapeutic substitution, i.e., replacing one drug with another chemically different drug from the same therapeutic class, represents an important therapeutic modification with potential clinical significance far beyond that of generic substitution. Adverse consequences following therapeutic substitution of nonsteroidal antiinflammatory drugs (NSAID) is of special concern because of substantial differences among these agents in pharmacokinetic, pharmacological, and clinical properties. Therapeutic substitution of NSAID for ambulatory patients may result in compromised clinical outcome because (1) patient response is unpredictable and selection of the optimal agent must be tailored for each patient; (2) substantial differences exist in adverse reaction profiles; (3) drug interaction studies are lacking; and (4) selection of an agent must be individualized to ensure compliance with the dosing regimen. Cost savings achieved through therapeutic substitution of NSAID may be lost by additional overall treatment costs due to adverse reactions or suboptimal therapy. The occurrence of adverse or suboptimal effects in ambulatory patients is more likely if NSAID are substituted without full knowledge of the patient's medical history and clinical status. Communication between the pharmacy and prescribing physician regarding a patient's specific needs is essential for rational substitution among NSAID.

Do differences in profiling criteria bias performance measurements? Economic profiling of medical clinics under the Korea National Health Insurance program: an observational study using claims data.

PubMed

Kang, Hee-Chung; Hong, Jae-Seok

2011-08-16

With a greater emphasis on cost containment in many health care systems, it has become common to evaluate each physician's relative resource use. This study explored the major factors that influence the economic performance rankings of medical clinics in the Korea National Health Insurance (NHI) program by assessing the consistency between cost-efficiency indices constructed using different profiling criteria. Data on medical care benefit costs for outpatient care at medical clinics nationwide were collected from the NHI claims database. We calculated eight types of cost-efficiency index with different profiling criteria for each medical clinic and investigated the agreement between the decile rankings of each index pair using the weighted kappa statistic. The exclusion of pharmacy cost lowered agreement between rankings to the lowest level, and differences in case-mix classification also lowered agreement considerably. A medical clinic may be identified as either cost-efficient or cost-inefficient, even when using the same index, depending on the profiling criteria applied. Whether a country has a single insurance or a multiple-insurer system, it is very important to have standardized profiling criteria for the consolidated management of health care costs.

Botulinum toxin type A products are not interchangeable: a review of the evidence

PubMed Central

Brin, Mitchell F; James, Charmaine; Maltman, John

2014-01-01

Botulinum toxin type A (BoNTA) products are injectable biologic medications derived from Clostridium botulinum bacteria. Several different BoNTA products are marketed in various countries, and they are not interchangeable. Differences between products include manufacturing processes, formulations, and the assay methods used to determine units of biological activity. These differences result in a specific set of interactions between each BoNTA product and the tissue injected. Consequently, the products show differences in their in vivo profiles, including preclinical dose response curves and clinical dosing, efficacy, duration, and safety/adverse events. Most, but not all, published studies document these differences, suggesting that individual BoNTA products act differently depending on experimental and clinical conditions, and these differences may not always be predictable. Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication. Moreover, the products differ in the amount of study to which they have been subjected, as evidenced by the number of publications in the peer-reviewed literature and the quantity and quality of clinical studies. Given that BoNTAs are potent biological products that meet important clinical needs, it is critical to recognize that their dosing and product performance are not interchangeable and each product should be used according to manufacturer guidelines. PMID:25336912

The trouble with sex differences.

PubMed

Eliot, Lise

2011-12-22

Sex differences in the brain are real and clinically important but often grossly distorted in popular discourse. Considering the public's deep fascination with sex difference research and its impact on issues from mental health to education and workplace equity, neuroscientists should pay greater heed to its misappropriation and to studying how gender enculturation shapes neural function. Copyright © 2011 Elsevier Inc. All rights reserved.

Negotiation skills for clinical research professionals

PubMed Central

Hake, Sanjay; Shah, Tapankumar

2011-01-01

Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors. PMID:21897886

Physicians' and nurses' expectations and objections toward a clinical ethics committee.

PubMed

Jansky, Maximiliane; Marx, Gabriella; Nauck, Friedemann; Alt-Epping, Bernd

2013-11-01

The study aimed to explore the subjective need of healthcare professionals for ethics consultation, their experience with ethical conflicts, and expectations and objections toward a Clinical Ethics Committee. Staff at a university hospital took part in a survey (January to June 2010) using a questionnaire with open and closed questions. Descriptive data for physicians and nurses (response rate = 13.5%, n = 101) are presented. Physicians and nurses reported similar high frequencies of ethical conflicts but rated the relevance of ethical issues differently. Nurses stated ethical issues as less important to physicians than to themselves. Ethical conflicts were mostly discussed with staff from one's own profession. Respondents predominantly expected the Clinical Ethics Committee to provide competent support. Mostly, nurses feared it might have no influence on clinical practice. Findings suggest that experiences of ethical conflicts might reflect interprofessional communication patterns. Expectations and objections against Clinical Ethics Committees were multifaceted, and should be overcome by providing sufficient information. The Clinical Ethics Committee needs to take different perspectives of professions into account.

Heart Failure Clinical Trials in East and Southeast Asia: Understanding the Importance and Defining the Next Steps

PubMed Central

Mentz, Robert J.; Roessig, Lothar; Greenberg, Barry H.; Sato, Naoki; Shinagawa, Kaori; Yeo, Daniel; Kwok, Bernard W.K.; Reyes, Eugenio B.; Krum, Henry; Pieske, Burkert; Greene, Stephen J.; Ambrosy, Andrew P.; Kelly, Jacob P.; Zannad, Faiez; Pitt, Bertram; Lam, Carolyn S.P.

2016-01-01

Heart failure (HF) is a major and increasing global public health problem. In Asia, aging populations and recent increases in cardiovascular risk factors have contributed to a particularly high burden of HF with similarly poor outcomes compared to the rest of the world. Representation of Asians in landmark HF trials has been variable. In addition, HF patients from Asia demonstrate clinical differences from other geographic regions. Thus, the generalizability of some clinical trials results to the Asian population remains uncertain. In this manuscript, we review differences in the HF phenotype, management and outcomes in patients from East and Southeast Asia. We describe lessons learned in Asia from recent HF registries and clinical trial databases and outline strategies to improve the potential for success in future trials. This review is based on discussions between scientists, clinical trialists, industry representatives and regulatory representatives at the CardioVascular Clinical Trialist Asia Forum on July 4, 2014. PMID:27256745

Malaria in paradise: characterization of imported cases in Gran Canaria Island (1993-2006).

PubMed

Espinosa-Vega, Elizabeth; Martín-Sánchez, Antonio Manuel; Elcuaz-Romano, Rosa; Hernández-Febles, Melisa; Molina-Cabrillana, Jesús; Pérez-Arellano, Jose Luis

2011-01-01

Spain obtained the official certificate of malaria eradication in 1964. However, imported malaria cases have been increasing during the last few decades in this country. This study aims to describe the clinical and epidemiological features of patients diagnosed with malaria on Gran Canaria Island. A retrospective study was conducted based on case review of all patients diagnosed with malaria microbiologically confirmed from 1993 to 2006, at the three referral teaching hospitals on Gran Canaria Island. One hundred eighty-four episodes in 181 patients were diagnosed, 170 of them were analyzed. Most of them (82%) were travelers. Nearly 15% (14.7%) declared having had some chemoprophylaxis, but only half of them completed the treatment. Twenty cases (10.9%) were diagnosed who had just arrived as immigrants, mainly children. Malaria was acquired in Africa by 94.7% of the cases and Plasmodium falciparum was responsible for the majority of the cases (84.1%). Clinical and epidemiological differences were observed among different groups of patients formed by their origin and travel purposes. At least one indicator of severe malaria was established in 22.9% of the cases. However, global mortality was 3.8%. Malaria in Gran Canaria Island is imported from endemic areas, mainly from African countries, observed mostly among young adult males, but clinical and epidemiological features may change among different groups of patients. The number of immigrants diagnosed with malaria is increasing in this area nowadays. © 2011 International Society of Travel Medicine.

Identification of different subsets of lung cells using Raman microspectroscopy and whole cell nucleus isolation.

PubMed

Pijanka, Jacek K; Stone, Nicholas; Rutter, Abigail V; Forsyth, Nicholas; Sockalingum, Ganesh D; Yang, Ying; Sulé-Suso, Josep

2013-09-07

Raman spectroscopy has been widely used to study its possible clinical application in cancer diagnosis. However, in order to make it into clinical practice, it is important that this technique is able not only to identify cancer cells from their normal counterparts, but also from the array of cells present in human tissues. To this purpose, we used Raman spectroscopy to assess whether this technique was able to differentiate not only between lung cancer cells and lung epithelial cells but also from lung fibroblasts. Furthermore, we studied whether the differences were due to cell lineage (epithelial versus fibroblast) or to different proliferative characteristics of cells, and where in the cell compartment these differences might reside. To answer these questions we studied cell cytoplasm, cell nucleus and isolated whole cell nuclei. Our data suggests that Raman spectroscopy can differentiate between lung cancer, lung epithelial cells and lung fibroblasts. More important, it can also differentiate between 2 cells from the same lineage (fibroblast) but with one of them rendered immortal and with an increased proliferative activity. Finally, it seems that the main spectral differences reside in the cell nucleus and that the study of isolated nuclei strengthens the differences between cells.

Student perception of two different simulation techniques in oral and maxillofacial surgery undergraduate training.

PubMed

Lund, Bodil; Fors, Uno; Sejersen, Ronny; Sallnäs, Eva-Lotta; Rosén, Annika

2011-10-12

Yearly surveys among the undergraduate students in oral and maxillofacial surgery at Karolinska Institutet have conveyed a wish for increased clinical training, and in particular, in surgical removal of mandibular third molars. Due to lack of resources, this kind of clinical supervision has so far not been possible to implement. One possible solution to this problem might be to introduce simulation into the curriculum. The purpose of this study was to investigate undergraduate students' perception of two different simulation methods for practicing clinical reasoning skills and technical skills in oral and maxillofacial surgery. Forty-seven students participating in the oral and maxillofacial surgery course at Karolinska Institutet during their final year were included. Three different oral surgery patient cases were created in a Virtual Patient (VP) Simulation system (Web-SP) and used for training clinical reasoning. A mandibular third molar surgery simulator with tactile feedback, providing hands on training in the bone removal and tooth sectioning in third molar surgery, was also tested. A seminar was performed using the combination of these two simulators where students' perception of the two different simulation methods was assessed by means of a questionnaire. The response rate was 91.5% (43/47). The students were positive to the VP cases, although they rated their possible improvement of clinical reasoning skills as moderate. The students' perception of improved technical skills after training in the mandibular third molar surgery simulator was rated high. The majority of the students agreed that both simulation techniques should be included in the curriculum and strongly agreed that it was a good idea to use the two simulators in concert. The importance of feedback from the senior experts during simulator training was emphasised. The two tested simulation methods were well accepted and most students agreed that the future curriculum would benefit from permanent inclusion of these exercises, especially when used in combination. The results also stress the importance of teaching technical skills and clinical reasoning in concert.

Clinically meaningful differences in pain, disability and quality of life for chronic nonspecific neck pain - a reanalysis of 4 randomized controlled trials of cupping therapy.

PubMed

Lauche, Romy; Langhorst, Jost; Dobos, Gustav J; Cramer, Holger

2013-08-01

The assessment of clinically meaningful differences in patients' self-reported outcomes has become increasingly important when interpreting the results of clinical studies. Although these assessments have become quite common there are hardly any data for nonspecific neck pain, especially in the context of complementary and alternative medicine. The aim of this analysis is the determination of minimal clinically important differences (MCID) and substantial clinical benefits (SCB) in patients with chronic nonspecific neck pain after cupping treatment. The data set comprised a total of 200 patients with chronic nonspecific neck pain participating in clinical trials on cupping therapy. The MCID and SCB for pain intensity (VAS), neck disability index (NDI) and the subscale bodily pain (SF-36-BP) as well as physical component summary (SF-36-PCS) of the SF-36 were determined using receiver operating characteristic (ROC) curve analysis with an adapted assessment of change in health status (SF-36), i.e. a 5-point Likert scale ranging from "much better" to "much worse", as anchor. MCID derived from the ROC was the score to distinguish "somewhat better" from "about the same", and the SCB was the score to distinguish "much better" from "somewhat better". The calculated MCIDs were: -8mm (-21%) for VAS, -3 points (-10.2%) for NDI, +10 points (+20.5%) for SF-36-BP and +2.6 points (+7.7%) for SF-36-PCS. The SCBs were: -26.5mm (-66.8%) for VAS, -8.4 points (-29%) for NDI, +15.5 points (+43.1%) for SF-36-BP and +5.1 points (+12.9%) for SF-36-PCS. Accuracy of the estimations was good for MCID in general and for SCB regarding VAS and NDI. The results support the assumption that patients' perceptions of treatment benefits measured by VAS in these trials might be comparable to others in conventional therapies. For NDI and SF-36-PCS the estimated differences were smaller than in previous reports indicating that context factors such as patient characteristics and specific treatment conditions might play an important role. Further studies on MCIDS and SCBs for chronic nonspecific neck pain seem warranted. Copyright © 2013 Elsevier Ltd. All rights reserved.

Endoscopic vs. Surgical Interventions for Painful Chronic Pancreatitis: What is Needed for Future Clinical Trials

PubMed Central

Windsor, John A; Reddy, Nageshwar D

2017-01-01

The treatment of painful chronic pancreatitis remains controversial. The available evidence from two randomized controlled trials favor surgical intervention, whereas an endotherapy-first approach is widely practiced. Chronic pancreatitis is complex disease with different genetic and environmental factors, different pain mechanisms and different treatment modalities including medical, endoscopic, and surgical. The widely practiced step-up approach remains unproven. In designing future clinical trials there are some important pre-requisites including a more comprehensive pain assessment tool, the optimization of conservative medical treatment and interventional techniques. Consideration should be given to the need of a control arm and the optimal timing of intervention. Pending better designed studies, the practical way forward is to identify subgroups of patients who clearly warrant endotherapy or surgery first, and to design the future clinical trials for the remainder. PMID:28079861

[Mild head injury in children and adults: Diagnostic challenges in the emergency department].

PubMed

Leidel, B A; Lindner, T; Wolf, S; Bogner, V; Steinbeck, A; Börner, N; Peiser, C; Audebert, H J; Biberthaler, P; Kanz, K-G

2015-06-01

Mild head injuries are one of the most frequent reasons for attending emergency departments and are particularly challenging in different ways. While clinically important injuries are infrequent, delayed or missed injuries may lead to fatal consequences. The initial mostly inconspicuous appearance may not reflect the degree of intracranial injury and computed tomography (CT) is necessary to rule out covert injuries. Furthermore, infants and young children with a lack of or rudimentary cognitive and language development are challenging, especially for those examiners not familiar with pediatric care. Established check lists of clinical risk factors for children and adults regarding traumatic brain injuries allow specific and rational decision-making for cranial CT imaging. Clinically important intracranial injuries can be reliably detected and unnecessary radiation exposure avoided at the same time.

[Mild head injury in children and adults. Diagnostic challenges in the emergency department].

PubMed

Leidel, B A; Lindner, T; Wolf, S; Bogner, V; Steinbeck, A; Börner, N; Peiser, C; Audebert, H J; Biberthaler, P; Kanz, K-G

2015-01-01

Mild head injuries are one of the most frequent reasons for attending emergency departments and are particularly challenging in different ways. While clinically important injuries are infrequent, delayed or missed injuries may lead to fatal consequences. The initial mostly inconspicuous appearance may not reflect the degree of intracranial injury and computed tomography (CT) is necessary to rule out covert injuries. Furthermore, infants and young children with a lack of or rudimentary cognitive and language development are challenging, especially for those examiners not familiar with pediatric care. Established check lists of clinical risk factors for children and adults regarding traumatic brain injuries allow specific and rational decision-making for cranial CT imaging. Clinically important intracranial injuries can be reliably detected and unnecessary radiation exposure avoided at the same time.

Virulence Factors of Helicobacter pylori: A Review

PubMed Central

Roesler, Bruna M.; Rabelo-Gonçalves, Elizabeth M.A.; Zeitune, José M.R.

2014-01-01

Helicobacter pylori is a spiral-shaped Gram-negative bacterium that colonizes the human stomach and can establish a long-term infection of the gastric mucosa, a condition that affects the relative risk of developing various clinical disorders of the upper gastrointestinal tract, such as chronic gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue (MALT) lymphoma, and gastric adenocarcinoma. H. pylori presents a high-level of genetic diversity, which can be an important factor in its adaptation to the host stomach and also for the clinical outcome of infection. There are important H. pylori virulence factors that, along with host characteristics and the external environment, have been associated with the different occurrences of diseases. This review is aimed to analyzing and summarizing the main of them and possible associations with the clinical outcome. PMID:24833944

Integrating fluoroquinolones into the hospital formulary.

PubMed

Bertino, J S

2001-10-01

With the increasing availability of new agents, selection of fluoroquinolones for formulary inclusion can be difficult. Appropriate evaluation of the important characteristics (pharmacokinetic and pharmacodynamic properties, antimicrobial activity, efficacy, tolerability, cost) of these agents should allow selection of the most cost-effective ones. Evidence from in vitro studies and clinical trials indicates differences exist among fluoroquinolones, especially in terms of activity against gram-positive, aerobic organisms. For selected clinical situations, it may be important to choose an agent that is available in both intravenous and oral formulations. Comparative drug costs, as well as costs associated with potential clinical failure and adverse events, should be evaluated carefully. Dosage regimens should be considered, as shorter durations of therapy and less frequent dose administration may lead to reduced labor costs and increased patient compliance, thereby improving effectiveness and economic efficiency.

Factors associated with clinical and perceived oral malodor among dental students.

PubMed

Rani, Haslina; Ueno, Masayuki; Zaitsu, Takashi; Furukawa, Sayaka; Kawaguchi, Yoko

2015-06-24

The objective of this study was to determine the prevalence of and factors associated with clinical and perceived oral malodor among dental students. Clinical oral malodor was measured in 163 Malaysian dental students using organoleptic method and Oral ChromaTM and they were asked about their perception of self-oral malodor. Oral examination was performed to assess oral health status. Statistical analyses were performed using SPSS version 19.0. There were 52.7% students who had clinical oral malodor, while 19.0% students perceived they had oral malodor. The sensitivity (0.244) of self-perceived oral malodor was lower than its specificity (0.870). Tongue coating was closely associated with clinical oral malodor whereas high plaque index was closely associated with perceived oral malodor. These results showed that clinical oral malodor was prevalent among dental students, but students' perception of oral malodor did not always reflect actual clinical oral malodor. Furthermore, associating factors of clinical oral malodor differ from perceived oral malodor. The importance of controlling clinical oral malodor with proper tongue cleaning should be emphasized and dental students should be taught on the differences between clinical and perceived oral malodor in order to manage this problem.

Quality assessment of clinical education services in teaching hospitals located in Kerman, Iran

PubMed Central

Yazdi-Feyzabadi, Vahid; Gozashti, Mohammad Hossein; Komsari, Samane; Mohammadtaghizadeh, Sedigheh; Amiresmaili, Mohammadreza

2015-01-01

Introduction Clinical education is one of the most important components of the resource generation function of health systems, and it has a very important role in graduates’ competency with respect to effective, practical education. This study aimed to assess the quality of clinical services in Kerman’s teaching hospitals located in southeastern Iran. Methods This cross-sectional study was conducted in 2011 on 303 medical students at different levels of medical education at Kerman’s teaching hospitals. A modified SERVQUAL instrument was used to collect the data after its validity and reliability were checked. The data were analyzed by SPSS 18.0 using the paired t-test, Kruskal-Wallis, and post hoc tests, when appropriate. Results In all five dimensions of quality, gaps were observed between students’ perceptions and expectations as follows: Assurance (mean = −1.18), Responsiveness (−1.56), Empathy (−1.4), Reliability (−1.27), and Tangibles (−1.21). There was a significant difference between the quality perceptions and expectations of the medical students (p < 0.001). A significant difference was observed between three educational levels, including externships, internships, and assistantships regarding the dimensions of the quality gaps (p < 0.001). Conclusion The clinical services provided by teaching hospitals in the study did not meet the students’ expectations at any of the three educational levels. As we precisely assessed the dimensions and items that had the higher quality gaps, it was apparent that, for most part, clinical education officials could improve the quality by designing interventions, which would not be very difficult to do. PMID:26767094

Dietary supplements for treating osteoarthritis: a systematic review and meta-analysis.

PubMed

Liu, Xiaoqian; Machado, Gustavo C; Eyles, Jillian P; Ravi, Varshini; Hunter, David J

2018-02-01

To investigate the efficacy and safety of dietary supplements for patients with osteoarthritis. An intervention systematic review with random effects meta-analysis and meta-regression. MEDLINE, EMBASE, Cochrane Register of Controlled Trials, Allied and Complementary Medicine and Cumulative Index to Nursing and Allied Health Literature were searched from inception to April 2017. Randomised controlled trials comparing oral supplements with placebo for hand, hip or knee osteoarthritis. Of 20 supplements investigated in 69 eligible studies, 7 (collagen hydrolysate, passion fruit peel extract, Curcuma longa extract, Boswellia serrata extract, curcumin, pycnogenol and L-carnitine) demonstrated large (effect size >0.80) and clinically important effects for pain reduction at short term. Another six (undenatured type II collagen, avocado soybean unsaponifiables, methylsulfonylmethane, diacerein, glucosamine and chondroitin) revealed statistically significant improvements on pain, but were of unclear clinical importance. Only green-lipped mussel extract and undenatured type II collagen had clinically important effects on pain at medium term. No supplements were identified with clinically important effects on pain reduction at long term. Similar results were found for physical function. Chondroitin demonstrated statistically significant, but not clinically important structural improvement (effect size -0.30, -0.42 to -0.17). There were no differences between supplements and placebo for safety outcomes, except for diacerein. The Grading of Recommendations Assessment, Development and Evaluation suggested a wide range of quality evidence from very low to high. The overall analysis including all trials showed that supplements provided moderate and clinically meaningful treatment effects on pain and function in patients with hand, hip or knee osteoarthritis at short term, although the quality of evidence was very low. Some supplements with a limited number of studies and participants suggested large treatment effects, while widely used supplements such as glucosamine and chondroitin were either ineffective or showed small and arguably clinically unimportant treatment effects. Supplements had no clinically important effects on pain and function at medium-term and long-term follow-ups. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Benefits of dietary fiber in clinical nutrition.

PubMed

Klosterbuer, Abby; Roughead, Zamzam Fariba; Slavin, Joanne

2011-10-01

Dietary fiber is widely recognized as an important part of a healthy diet and is a common addition to enteral nutrition (EN) formulas. Fiber sources differ in characteristics such as solubility, fermentability, and viscosity, and it is now well known that different types of fiber exert varying physiological effects in the body. Clinical studies suggest fiber can exert a wide range of benefits in areas such as bowel function, gut health, immunity, blood glucose control, and serum lipid levels. Although early clinical nutrition products contained fiber from a single source, it is now thought that blends of fiber from multiple sources more closely resemble a regular diet and may provide a greater range of benefits for the patient. Current recommendations support the use of dietary fiber in clinical nutrition when no contraindications exist, but little information exists about which types and combinations of fibers provide the relevant benefit in certain patient populations. This article summarizes the different types of fiber commonly added to EN products and reviews the current literature on the use of fiber blends in clinical nutrition.

Group Psychotherapy in Italy.

PubMed

Giannone, Francesca; Giordano, Cecilia; Di Blasi, Maria

2015-10-01

This article describes the history and the prevailing orientations of group psychotherapy in Italy (psychoanalytically oriented, psychodrama, CBT groups) and particularly group analysis. Provided free of charge by the Italian health system, group psychotherapy is growing, but its expansion is patchy. The main pathways of Italian training in the different group psychotherapy orientations are also presented. Clinical-theoretical elaboration on self development, psychopathology related to group experiences, and the methodological attention paid to objectives and methods in different clinical groups are issues related to group therapy in Italy. Difficulties in the relationship between research and clinical practice are discussed, as well as the empirical research network that tries to bridge the gap between research and clinical work in group psychotherapy. The economic crisis in Italy has led to massive cuts in health care and to an increasing demand for some forms of psychological treatment. For these reasons, and because of its positive cost-benefit ratio, group psychotherapy is now considered an important tool in the national health care system to expand the clinical response to different forms of psychological distress.

Low-molecular-weight heparins: pharmacologic profile and product differentiation.

PubMed

Fareed, J; Jeske, W; Hoppensteadt, D; Clarizio, R; Walenga, J M

1998-09-10

The interchangeability of low-molecular-weight heparins (LMWHs) has been the subject of discussion since these products were first introduced for the prophylaxis of deep vein thrombosis. Experimental evidence now exists to show that LMWHs differ from each other in a number of characteristics. Products have been differentiated on the basis of molecular weight and biologic properties, but only limited information derived from the clinical setting is available. Potency has been described on the basis of anti-Factor Xa activity, but at equivalent anti-Xa activities, the anti-Factor IIa activity of different products shows marked variations. At the relatively small doses used for the management of postsurgical deep vein thrombosis, the effect of these interproduct differences may be relatively minor, but as LMWHs are developed for therapeutic use at much higher doses, such differences may become clinically important. Variations in safety and efficacy reported in clinical trials of LMWHs may reflect the known differences in their molecular composition and pharmacologic properties.

Eating disorders in the context of preconception care: fertility specialists' knowledge, attitudes, and clinical practices.

PubMed

Rodino, Iolanda S; Byrne, Susan M; Sanders, Katherine A

2017-02-01

To gauge fertility specialists' knowledge, clinical practices, and training needs in regard to eating disorders. Cross-sectional study. Fertility clinics. Eighty Australian and New Zealand fertility specialists who were members of the Fertility Society of Australia. None. Responses to an anonymously completed online questionnaire. Approximately 54% of doctors correctly identified the body mass index relevant to anorexia nervosa, and 30% identified menstrual disturbances for anorexia, while 63.8% of doctors incorrectly nominated maladaptive weight control behaviors as a characteristic of binge eating disorder. While clinicians (83.7%) agreed it was important to screen for eating disorders during preconception assessments, 35% routinely screened for eating disorders and 8.8% indicated that their clinics had clinical practice guidelines for management of eating disorders. A minority of participants (13.8%) felt satisfied with their level of university training in eating disorders, 37.5% of doctors felt confident in their ability to recognize symptoms of an eating disorder, and 96.2% indicated a need for further education and clinical guidelines. On most items examined, knowledge and clinical practices regarding eating disorders did not differ according to doctor gender or years of clinical experience working as a fertility specialist. Knowledge about eating disorders in the context of fertility treatment is important. This study highlights the uncertainty among fertility specialists in detecting features of eating disorders. The findings point to the importance of further education and training, including the development of clinical guidelines specific to fertility health care providers. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Full investigation of patients with polycystic ovary syndrome (PCOS) presenting to four different clinical specialties reveals significant differences and undiagnosed morbidity.

PubMed

Sivayoganathan, Dhakshana; Maruthini, Deivanayagam; Glanville, Julie M; Balen, Adam H

2011-12-01

This study aimed to compare the spectrum of polycystic ovary syndrome (PCOS) symptoms in patients from four different specialist clinics. A prospective cross-sectional observational study. The study was conducted at the infertility, gynaecology, endocrine and dermatology clinics at Leeds General Infirmary, U.K. Seventy women presenting with features of PCOS: 20 from infertility, 17 from gynaecology, 17 from dermatology and 16 from endocrine clinics. Participants were assessed for symptoms and signs of PCOS and underwent a full endocrine and metabolic profile and a pelvic ultrasound scan. All subjects had experienced menstrual problems, 81% were overweight, 86% had polycystic ovaries on ultrasound, 56% had hirsutism, 53% had acne, 23% had acanthosis nigricans, 16% had alopecia and 38% had previously undiagnosed impaired glucose tolerance (IGT) or diabetes. A significant difference between the four clinic groups existed with regard to menstrual patterns (p = 0.0234), frequency distribution of presenting symptoms and the percentages of patients with PCOS who had already been diagnosed as having PCOS (p = 0.0088). This study emphasizes the importance of understanding the full spectrum of PCOS as presented to different specialty clinics. Not only is the syndrome under diagnosed but also are the significant associated morbidities such as IGT and type 2 diabetes. Different specialists need to appreciate the spectrum of health problems for women with PCOS that may extend beyond the specific symptoms that precipitated the initial referral.

PREDICTORS OF PHYSICIAN REFERRAL FOR PATIENT RECRUITMENT TO ALZHEIMER DISEASE CLINICAL TRIALS

PubMed Central

Galvin, James E.; Meuser, Thomas M.; Boise, Linda; Connell, Cathleen M

2009-01-01

Background Inadequate recruitment into Alzheimer disease (AD) clinical trials is an important threat to the validity and generalizability of the studies. The majority of dementia patients are first evaluated by community-based physicians; however, physician perceptions of clinical research are largely unknown. Methods A survey was distributed to 3,123 physicians in three states; 370 were returned. Survey items assessed attitudes, perceived benefits of and barriers to referral to clinical research and physicians use of the internet for medical information. Results The mean age of the respondents was 50.6 ± 10.8y; 70% were male, 78% Caucasian, 61% were primary care providers; 63% used the internet ≥3 times/week. No demographic or medical specialty differences existed between those who were likely (n=193) and unlikely (n=162) to refer patients to clinical trials. Differences were discovered in perceived benefits reported by physicians who were more likely to refer, while differences in perceived barriers existed in primary care compared with specialists. Referral to clinical trials is predicted by close proximity to a research center (OR:4.0,95%CI:1.1–15.6) and availability of internet information regarding diagnostic evaluation (OR:2.3,95%CI:1.1–4.7). Primary barriers included concerns about exposure of patients to uncomfortable procedures (OR:4.7,95%CI:1.2–18.7) and lack of time to discuss research participation (OR:6.8,95%CI:1.4–32.3). Conclusions Proximity to a research center and availability of diagnostic clinical tools are strong predictors of clinical trial referral. Concern over risks to patients and lack of time are strong barriers. These results suggest that dementia outreach education targeted to physicians should emphasize the importance of clinical trials with a focus on discussing research participation in a time-efficient manner and increasing awareness of risk reduction and the safety of research protocols. Providing easy access to up-to-date, user-friendly educational materials on dementia diagnosis and research via the internet are likely to improve referrals of patients to AD clinical trials from community physicians. PMID:19561438

Predictors of physician referral for patient recruitment to Alzheimer disease clinical trials.

PubMed

Galvin, James E; Meuser, Thomas M; Boise, Linda; Connell, Cathleen M

2009-01-01

Inadequate recruitment into Alzheimer disease clinical trials is an important threat to the validity and generalizability of the studies. The majority of dementia patients are first evaluated by community-based physicians; however, physician perceptions of clinical research are largely unknown. A survey was distributed to 3123 physicians in 3 states; 370 were returned. Survey items assessed attitudes, perceived benefits of and barriers to referral to clinical research, and physicians use of the internet for medical information. The mean age of the respondents was 50.6+/-10.8 years; 70% were male, 78% white, 61% were primary care providers; 63% used the internet > or =3 times/week. No demographic or medical specialty differences existed between those who were likely (n=193) and unlikely (n=162) to refer patients to clinical trials. Differences were discovered in perceived benefits reported by physicians who were more likely to refer, whereas differences in perceived barriers existed in primary care compared with specialists. Referral to clinical trials is predicted by close proximity to a research center [odds ratio (OR): 4.0; 95% confidence interval (CI), 1.1-15.6] and availability of internet information regarding diagnostic evaluation (OR: 2.3; 95% CI, 1.1-4.7). Primary barriers included concerns about exposure of patients to uncomfortable procedures (OR: 4.7; 95% CI, 1.2-18.7) and lack of time to discuss research participation (OR: 6.8; 95% CI, 1.4-32.3). Proximity to a research center and availability of diagnostic clinical tools are strong predictors of clinical trial referral. Concern over risks to patients and lack of time are strong barriers. These results suggest that dementia outreach education targeted to physicians should emphasize the importance of clinical trials with a focus on discussing research participation in a time-efficient manner and increasing awareness of risk reduction and the safety of research protocols. Providing easy access to up-to-date, user-friendly educational materials on dementia diagnosis and research via the internet are likely to improve referrals of patients to Alzheimer disease clinical trials from community physicians.

Influence of age on the pattern and outcome of external beam radiotherapy for clinically localized prostate cancer.

PubMed

Ogawa, Kazuhiko; Nakamura, Katsumasa; Onishi, Hiroshi; Koizumi, Masahiko; Sasaki, Tomonari; Araya, Masayuki; Miyabe, Yuuki; Otani, Yuuki; Teshima, Teruki

2006-01-01

The influence of age on the patterns and outcomes of external beam radiotherapy for clinically localized prostate cancer patients was examined. The Japanese Patterns of Care Study surveys were used to compare the processes and outcomes of radical external beam radiotherapy in 140 elderly patients (>75 years old) and 304 younger patients (<75 years old). Although the Karnofsky performance status was significantly different between elderly and younger patients, there were no significant differences in disease characteristics such as pretreatment PSA level, differentiation, Gleason combined score and clinical T stage. There were also no significant differences in the treatment characteristics such as CT-based treatment planning, conformal therapy, total radiation doses (both a median of 66.0 Gy) and hormonal therapy usage. Moreover, no significant differences in overall survival, biochemical relapse-free survival and late toxicity rates were observed between elderly and younger patients. Age did not influence the disease characteristics, patterns of external beam radiotherapy, survival and late toxicities for clinically localized prostate cancer patients. Therefore, radiotherapy could represent an important treatment modality for elderly patients as well as for younger ones.

A multicenter study: how do medical students perceive clinical learning climate?

PubMed Central

Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

2016-01-01

Background The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students’ perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Methods Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). Results The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. Conclusion The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students’ interactions in clinical settings, self-realization, mood, students’ intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve clinical learning climate. PMID:27640648

Comparison of manual and automated nucleic acid extraction methods from clinical specimens for microbial diagnosis purposes.

PubMed

Wozniak, Aniela; Geoffroy, Enrique; Miranda, Carolina; Castillo, Claudia; Sanhueza, Francia; García, Patricia

2016-11-01

The choice of nucleic acids (NAs) extraction method for molecular diagnosis in microbiology is of major importance because of the low microbial load, different nature of microorganisms, and clinical specimens. The NA yield of different extraction methods has been mostly studied using spiked samples. However, information from real human clinical specimens is scarce. The purpose of this study was to compare the performance of a manual low-cost extraction method (Qiagen kit or salting-out extraction method) with the automated high-cost MagNAPure Compact method. According to cycle threshold values for different pathogens, MagNAPure is as efficient as Qiagen for NA extraction from noncomplex clinical specimens (nasopharyngeal swab, skin swab, plasma, respiratory specimens). In contrast, according to cycle threshold values for RNAseP, MagNAPure method may not be an appropriate method for NA extraction from blood. We believe that MagNAPure versatility reduced risk of cross-contamination and reduced hands-on time compensates its high cost. Copyright © 2016 Elsevier Inc. All rights reserved.

The interaction between equipoise and logistics in clinical trials: A case study.

PubMed

Warshaw, Meredith G; Carey, Vincent J; McFarland, Elizabeth J; Dawson, Liza; Abrams, Elaine; Melvin, Ann; Fairlie, Lee; Spiegel, Hans; Jay, Jonathan; Agwu, Allison L

2017-06-01

Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications. Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials. There are also logistical barriers to enrollment in international trials due to prolonged timelines for approvals by government agencies and ethical review boards. A multinational clinical trial of bridging strategies for treatment of non-adherent HIV-infected youth, experienced differing perceptions of equipoise due to disparities in availability of treatment options by country. Unfortunately, the countries with most demand for the trial were those where the approval process was most delayed, and the study was closed early due to slow accrual. When planning multicenter clinical trials, it is important to take into account heterogeneity among research sites and try to anticipate differences in equipoise and logistical factors between sites, in order to plan to address these issues at the design stage.

Design and analysis issues for economic analysis alongside clinical trials.

PubMed

Marshall, Deborah A; Hux, Margaret

2009-07-01

Clinical trials can offer a valuable and efficient opportunity to collect the health resource use and outcomes data for economic evaluation. However, economic and clinical studies differ fundamentally in the question they seek to answer. The design and analysis of trial-based cost-effectiveness studies require special consideration, which are reviewed in this article. Traditional randomized controlled trials, using an experimental design with a controlled protocol, are designed to measure safety and efficacy for product registration. Cost-effectiveness analysis seeks to measure effectiveness in the context of routine clinical practice, and requires collection of health care resources to allow estimation of cost over an equal timeframe for each treatment alternative. In assessing suitability of a trial for economic data collection, the comparator treatment and other protocol factors need to reflect current clinical practice and the trial follow-up must be sufficiently long to capture important costs and effects. The broadest available population and a measure of effectiveness reflecting important benefits for patients are preferred for economic analyses. Special analytical issues include dealing with missing and censored cost data, assessing uncertainty of the incremental cost-effectiveness ratio, and accounting for the underlying heterogeneity in patient subgroups. Careful consideration also needs to be given to data from multinational studies since practice patterns can differ across countries. Although clinical trials can be an efficient opportunity to collect data for economic evaluation, careful consideration of the suitability of the study design, and appropriate analytical methods must be applied to obtain rigorous results.

Aggressive behavior and poor prognosis of endometrial stromal sarcomas with YWHAE-FAM22 rearrangement indicate the clinical importance to recognize this subset.

PubMed

Kruse, Arnold-Jan; Croce, Sabrina; Kruitwagen, Roy F P M; Riedl, Robert G; Slangen, Brigitte F M; Van Gorp, Toon; Van de Vijver, Koen K

2014-11-01

Although the World Health Organization (WHO) in 2003 defined endometrial stromal sarcomas (ESSs) in general have a good prognosis, considerable differences in clinical behavior and prognosis may exist between different patients with ESS. The ESSs of the type associated with YWHAE-NUTM2 (previously named YWHAE-FAM22) fusion have a more aggressive clinical behavior and poorer prognosis than conventional ESS. Recently, the WHO 2014 classification recognizes this subset of ESS as a separate entity and classifies these as high-grade ESSs. Recognition of this subset has therefore an important clinical impact. We performed a review of the literature to delineate the clinicopathologic features of ESS patients with an YWHAE-NUTM2 rearrangement, with the goal to recognize this subset of ESS. We report a case of a woman with WHO 2014-defined high-grade ESS. Furthermore, published English literature was reviewed for YWHAE-FAM22 ESS and uterus. Twenty patients were identified, with a median age of 50 (range, 28-67) years. There were no clinical features able to recognize YWHAE-NUTM2 ESS. However, they characteristically contain specific histopathological features. Furthermore, YWHAE-NUTM2 ESSs are strongly cyclin D1 positive in contrast to conventional low-grade ESSs. YWHAE-NUTM2 ESSs represent a subset of ESSs with an aggressive clinical behavior and poor prognosis. Specific histopathological features may indicate the presence of YWHAE-NUTM2 rearrangement, which subsequently can be confirmed by cyclin D1 immunostaining.

Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire

PubMed Central

Kocks, JWH; Tuinenga, MG; Uil, SM; van den Berg, JWK; Ståhl, E; van der Molen, T

2006-01-01

Background Patient-reported outcomes (PRO) questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID). This study aimed to identify the MCID for the clinical COPD questionnaire (CCQ) in terms of patient referencing, criterion referencing, and by the standard error of measurement (SEM). Methods Patients were ≥40 years of age, diagnosed with COPD, had a smoking history of >10 pack-years, and were participating in a randomized, controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD. The CCQ was completed on Days 1–7 and 42. A Global Rating of Change (GRC) assessment was taken to establish the MCID by patient referencing. For criterion referencing, health events during a period of 1 year after Day 42 were included in this analysis. Results 210 patients were recruited, 168 completed the CCQ questionnaire on Day42. The MCID of the CCQ total score, as indicated by patient referencing in terms of the GRC, was 0.44. The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39, and calculation of the SEM resulted in a value of 0.21. Conclusion This investigation, which is the first to determine the MCID of a PRO questionnaire via more than one approach, indicates that the MCID of the CCQ total score is 0.4. PMID:16603063

Minimal clinically important difference in the fibromyalgia impact questionnaire.

PubMed

Bennett, Robert M; Bushmakin, Andrew G; Cappelleri, Joseph C; Zlateva, Gergana; Sadosky, Alesia B

2009-06-01

The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to <39 was found to represent a mild effect, >or= 39 to <59 a moderate effect, and >or=59 to 100 a severe effect. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice.

Hyaluronic acid in the treatment of knee osteoarthritis: a systematic review and meta-analysis with emphasis on the efficacy of different products.

PubMed

Colen, Sascha; van den Bekerom, Michel P J; Mulier, Michiel; Haverkamp, Daniël

2012-08-01

Although accepted as a conservative treatment option for knee osteoarthritis, the debate about the effectiveness of intra-articular treatment with hyaluronic acid (HA) is still ongoing because of contrasting outcomes in different clinical studies. Several well designed clinical studies showed a significant improvement in pain at follow-up compared with baseline but no significant improvement comparing the efficacy of HA with placebo (saline) or with other conservative treatment options. Notwithstanding the effectiveness of different types of intra-articular HA products, the question of whether one HA product is better than another is still unanswered. In this systematic review we compare the effects of intra-articularly administered HA with intra-articularly administered placebo in general and, more specifically, the effects of individual HA products with placebo. We also compare the efficacy of different HA products. A systematic review of randomized controlled trials (RCTs) was conducted using databases including MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trial Register and EMBASE. Seventy-four RCTs were included in this systematic review. HA improves pain by approximately 40-50% compared with baseline levels. However, when compared with saline the difference in efficacy is not that large. Due to a large 'placebo effect' of saline (approximately 30% pain reduction, persisting for at least 3 months) we determined a weighted mean difference between the efficacy of HA and saline of just 10.20 using the visual analog scale for pain. It is debatable whether this difference reaches the minimum clinically important difference. Comparing the different HA products, which vary in the molecular weight, concentration, and volume of HA, we were not able to conclude that one brand has a better efficacy than another due to the heterogeneity of the studies and outcomes. In the future it will be important to determine the exact mechanism of action of placebo as this may give us an idea of how to treat osteoarthritis more efficiently. Due to the limitations of this review (follow-up of just 3 months and large heterogeneity of the included studies), it is also important to compare the different HA products to determine which product(s), or which molecular weight range, concentration, or volume of HA is the best option to treat osteoarthritis. Our recommendation is to start large (multicenter) RCTs to give us more evidence about the efficacy of the different HA products.

Clinically important improvement in function is common in people with or at high risk of knee OA: the MOST study

PubMed Central

White, Daniel K.; Keysor, Julie J.; LaValley, Michael P.; Lewis, Cora E.; Torner, James C.; Nevitt, Michael C.; Felson, David T.

2010-01-01

To calculate the frequency of clinically important improvement in function over 30 months and identify risk factors in people who have or are at risk of knee OA. Subjects were from MOST, a longitudinal study of persons with or at high risk of knee OA. We defined Minimal Clinically Important Improvement (MCII) with WOMAC physical function using three different methods. Baseline risk factors tested for improvement included age, gender, educational attainment, presence of radiographic knee OA (ROA), the number of comorbidities, Body Mass Index (BMI), knee pain, walking speed, isokinetic knee extensor strength, depressive symptoms, physical activity, and medication usage. We used logistic regression to evaluate the association of baseline risk factors with MCII. Of the 1801 subjects (age= 63, BMI= 31, 63% female), most had mild limitations in baseline function (WOMAC = 19 +/− 11). Regardless how defined, a substantial percentage of subjects (24%–39%) reached MCII at 30 months. Compared to their counterparts, people with MCII were less likely to have ROA and to use medications, and were more likely to have a lower BMI, less knee pain, a faster walking speed, more knee strength, and fewer depressive symptoms. After adjustment, MCII was 40% to 50% less likely in those with ROA, and 1.9 to 2.0 times more likely in those walking 1.0 m/s faster than counterparts. Clinically important improvement is frequent in people with or at high risk of knee OA. The absence of ROA and a faster walking speed appear to be associated with clinically important improvements. PMID:20395640

Between trust and accountability: different perspectives on the modernization of postgraduate medical training in the Netherlands.

PubMed

Wallenburg, Iris; van Exel, Job; Stolk, Elly; Scheele, Fedde; de Bont, Antoinette; Meurs, Pauline

2010-06-01

Postgraduate medical training was reformed to be more responsive to changing societal needs. In the Netherlands, as in various other Western countries, a competency-based curriculum was introduced reflecting the clinical and nonclinical roles a modern doctor should fulfill. It is still unclear, however, what this modernization process exactly comprises and what its consequences might be for clinical practice and medical work. The authors conducted a Q methodological study to investigate which different perspectives exist on the modernization of postgraduate medical training among actors involved. The authors found four distinct perspectives, reflecting the different features of medical training. The accountability perspective stresses the importance of formal regulations within medical training and the monitoring of results in order to be more transparent and accountable to society. According to the educational perspective, medical training should be more formalized and directed at the educational process. The work-life balance perspective stresses the balance between a working life and a private life, as well as the changing professional relationship between staff members and residents. The trust-based perspective reflects the classic view of medical training in which role modeling and trust are considered most important. The four perspectives on the modernization of postgraduate medical training show that various aspects of the modernization process are valued differently by stakeholders, highlighting important sources of agreement and disagreement between them. An important source of disagreement is diverging expectations of the role of physicians in modern medical practice.

Exploring Sex Differences in Autistic Traits: A Factor Analytic Study of Adults with Autism

ERIC Educational Resources Information Center

Grove, Rachel; Hoekstra, Rosa A.; Wierda, Marlies; Begeer, Sander

2017-01-01

Research has highlighted potential differences in the phenotypic and clinical presentation of autism spectrum conditions across sex. Furthermore, the measures utilised to evaluate autism spectrum conditions may be biased towards the male autism phenotype. It is important to determine whether these instruments measure the autism phenotype…

Minimally important difference for the Expanded Prostate Cancer Index Composite Short Form.

PubMed

Skolarus, Ted A; Dunn, Rodney L; Sanda, Martin G; Chang, Peter; Greenfield, Thomas K; Litwin, Mark S; Wei, John T

2015-01-01

To establish a score threshold that constitutes a clinically relevant change for each domain of the Expanded Prostate Cancer Index Composite (EPIC) Short Form (EPIC-26). Although its use in clinical practice and clinical trials has increased worldwide, the clinical interpretation of this 26-item disease-specific patient-reported quality of life questionnaire for men with localized prostate cancer would be facilitated by characterization of score thresholds for clinically relevant change (the minimally important differences [MIDs]). We used distribution- and anchor-based approaches to establish the MID range for each EPIC-26 domain (urinary, sexual, bowel, and vitality/hormonal) based on a prospective multi-institutional cohort of 1201 men treated for prostate cancer between 2003 and 2006 and followed up for 3 years after treatment. For the anchor-based approach, we compared within-subject and between-subject score changes for each domain to an external "anchor" measure of overall cancer treatment satisfaction. We found the bowel and vitality/hormonal domains to have the lowest MID range (a 4-6 point change should be considered clinically relevant), whereas the sexual domain had the greatest MID values (10-12). Urinary incontinence appeared to have a greater MID range (6-9) than the urinary irritation/obstruction domain (5-7). Using 2 independent approaches, we established the MIDs for each EPIC-26 domain. A definition of these MID values is essential for the researcher or clinician to understand when changes in symptom burden among prostate cancer survivors are clinically relevant. Copyright © 2015 Elsevier Inc. All rights reserved.

The effectiveness of an air cleaner in controlling droplet/aerosol particle dispersion emitted from a patient's mouth in the indoor environment of dental clinics.

PubMed

Chen, Chun; Zhao, Bin; Cui, Weilin; Dong, Lei; An, Na; Ouyang, Xiangying

2010-07-06

Dental healthcare workers (DHCWs) are at high risk of occupational exposure to droplets and aerosol particles emitted from patients' mouths during treatment. We evaluated the effectiveness of an air cleaner in reducing droplet and aerosol contamination by positioning the device in four different locations in an actual dental clinic. We applied computational fluid dynamics (CFD) methods to solve the governing equations of airflow, energy and dispersion of different-sized airborne droplets/aerosol particles. In a dental clinic, we measured the supply air velocity and temperature of the ventilation system, the airflow rate and the particle removal efficiency of the air cleaner to determine the boundary conditions for the CFD simulations. Our results indicate that use of an air cleaner in a dental clinic may be an effective method for reducing DHCWs' exposure to airborne droplets and aerosol particles. Further, we found that the probability of droplet/aerosol particle removal and the direction of airflow from the cleaner are both important control measures for droplet and aerosol contamination in a dental clinic. Thus, the distance between the air cleaner and droplet/aerosol particle source as well as the relative location of the air cleaner to both the source and the DHCW are important considerations for reducing DHCWs' exposure to droplets/aerosol particles emitted from the patient's mouth during treatments.

The effectiveness of an air cleaner in controlling droplet/aerosol particle dispersion emitted from a patient's mouth in the indoor environment of dental clinics

PubMed Central

Chen, Chun; Zhao, Bin; Cui, Weilin; Dong, Lei; An, Na; Ouyang, Xiangying

2010-01-01

Dental healthcare workers (DHCWs) are at high risk of occupational exposure to droplets and aerosol particles emitted from patients' mouths during treatment. We evaluated the effectiveness of an air cleaner in reducing droplet and aerosol contamination by positioning the device in four different locations in an actual dental clinic. We applied computational fluid dynamics (CFD) methods to solve the governing equations of airflow, energy and dispersion of different-sized airborne droplets/aerosol particles. In a dental clinic, we measured the supply air velocity and temperature of the ventilation system, the airflow rate and the particle removal efficiency of the air cleaner to determine the boundary conditions for the CFD simulations. Our results indicate that use of an air cleaner in a dental clinic may be an effective method for reducing DHCWs' exposure to airborne droplets and aerosol particles. Further, we found that the probability of droplet/aerosol particle removal and the direction of airflow from the cleaner are both important control measures for droplet and aerosol contamination in a dental clinic. Thus, the distance between the air cleaner and droplet/aerosol particle source as well as the relative location of the air cleaner to both the source and the DHCW are important considerations for reducing DHCWs' exposure to droplets/aerosol particles emitted from the patient's mouth during treatments. PMID:20031985

Determining the Minimal Clinically Important Difference for Six-Minute Walk Distance in Fibromyalgia

PubMed Central

Kaleth, Anthony S.; Slaven, James E.; Ang, Dennis C.

2016-01-01

Objective To estimate the minimal clinically important difference (MCID) for 6-minute walk distance (6MWD) in patients with fibromyalgia (FM). Design Data from a recently completed trial that included 187 patients who completed the 6-minute walk test, Fibromyalgia Impact Questionnaire (FIQ), and Short-Form 36 (SF36) at 12 and 36 weeks were used to examine longitudinal changes in 6MWD. An anchor-based approach that used linear regression analyses was used to determine the MCID for 6MWD, using the total FIQ score (FIQ-Total) and SF36-physical function domain (SF36-PF) as clinical anchors. Results The mean (SD) change in 6MWD from baseline to week 36 was 34.4 (65.2) m (p<0.001). The anchor-based MCID’s for the 6MWD were 156 m and 167 m for the FIQ and SF36-PF, respectively. These MCID’s correspond with clinically meaningful improvements in FIQ (14% reduction) and SF36-PF (10 point increase). Conclusion The MCID for 6MWD in patients with FM was 156 to 167 m. These findings provide the first evidence of the change in 6MWD that is perceived by patients to be clinically meaningful. Further research using other MCID calculation methods is needed to refine estimates of the MCID for 6MWD in patients with FM. PMID:27003201

Determining the Minimal Clinically Important Difference for 6-Minute Walk Distance in Fibromyalgia.

PubMed

Kaleth, Anthony S; Slaven, James E; Ang, Dennis C

2016-10-01

The aim of this study was to estimate the minimal clinically important difference (MCID) for 6-min walk distance (6MWD) in patients with fibromyalgia. Data from a recently completed trial that included 187 patients who completed the 6-min walk test, Fibromyalgia Impact Questionnaire (FIQ), and Short-Form 36 (SF36) at 12 and 36 wks were used to examine longitudinal changes in 6MWD. An anchor-based approach that used linear regression analyses was used to determine the MCID for 6MWD, using the total FIQ score (FIQ-Total) and SF36-physical function domain as clinical anchors. The mean (SD) change in 6MWD from baseline to week 36 was 34.4 (65.2) m (P < 0.001). The anchor-based MCIDs for the 6MWD were 156 and 167 m for the FIQ and SF36-physical function domain, respectively. These MCIDs correspond with clinically meaningful improvements in FIQ (14% reduction) and SF36-physical function domain (10-point increase). The MCID for 6MWD in patients with fibromyalgia was 156 to 167 m. These findings provide the first evidence of the change in 6MWD that is perceived by patients to be clinically meaningful. Further research using other MCID calculation methods is needed to refine estimates of the MCID for 6MWD in patients with fibromyalgia.

Systematic review and benchmarking of Quality-Adjusted Time Without Symptoms or Toxicity (Q-TWiST) in oncology.

PubMed

Solem, Caitlyn T; Kwon, Youngmin; Shah, Ruchit M; Aly, Abdalla; Botteman, Marc F

2018-02-05

The Quality-Adjusted Time Without Symptoms or Toxicity (Q-TWiST) has been used to evaluate the clinical benefits and risks of oncology treatments. However, limited information is available to interpret and contextualize Q-TWiST results. Areas covered: A systematic review of Q-TWiST literature was conducted to provide contextualizing benchmarks for future studies. 51 articles with 81 unique Q-TWiST comparisons were identified. The mean (95% CI) and median absolute Q-TWiST gains for treatment versus control arms were 2.78 (1.82-3.73) months and 2.20 months across all cancers, respectively. The mean (median) relative Q-TWiST gains were 7.8% (7.2%) across all cancers. Most (88%) studies reported positive gains. The percentage of studies with relative Q-TWiST gains ≥10% (ie, clinically important difference) and ≥15% (ie, clearly clinically important difference) were 40.0% and 22.7%, respectively. Expert commentary: The relevance of Q-TWiST in assessing net clinical benefits of cancer therapy has not diminished, despite an arguably low number of published studies. The interest in such assessment is highlighted by the recent emergence of oncology value frameworks. The Q-TWiST should be compelling to clinicians as it integrates clinical information (ie, toxicity, relapse/progression, and survival) and patient preferences for each of these states into a single meaningful index.

Epidermal growth factor receptor expression in different subtypes of oral lichenoid disease.

PubMed

Cortés-Ramírez, Dionisio-Alejandro; Rodríguez-Tojo, María-Jose; Coca-Meneses, Juan-Carlos; Marichalar-Mendia, Xabier; Aguirre-Urizar, José-Manuel

2014-09-01

The oral lichenoid disease (OLD) includes different chronic inflammatory processes such as oral lichen planus (OLP) and oral lichenoid lesions (OLL), both entities with controversial diagnosis and malignant potential. Epidermal growth factor receptor (EFGR) is an important oral carcinogenesis biomarker and overexpressed in several oral potentially malignant disorders. To analyze the EGFR expression in the OLD to find differences between OLP and OLL, and to correlate it with the main clinical and pathological features. Forty-four OLD cases were studied and classified according to their clinical (Group C1: only papular lesions / Group C2: papular and other lesions) and histopathological features (Group HT: OLP-typical / Group HC: OLP-compatible) based in previous published criteria. Standard immunohistochemical identification of EGFR protein was performed. Comparative and descriptive statistical analyses were performed. Thirty-five cases (79.5%) showed EGFR overexpression without significant differences between clinical and histopathological groups (p<0.05). Histological groups showed significant differences in the EGFR expression pattern (p=0.016). Conlusions: All OLD samples showed high EGFR expression. The type of clinical lesion was not related with EGFR expression; however, there are differences in the EGFR expression pattern between histological groups that may be related with a different biological profile and malignant risk.

Theta Burst Stimulation in the Rehabilitation of the Upper Limb: A Semirandomized, Placebo-Controlled Trial in Chronic Stroke Patients

PubMed Central

Talelli, Penelope; Wallace, Amanda; Dileone, Michelle; Hoad, Damon; Cheeran, Binith; Oliver, Rupert; VandenBos, Mehdi; Hammerbeck, Ulrike; Barratt, Karen; Gillini, Cecilia; Musumeci, Gabriella; Boudrias, Marie-Hélène; Cloud, Geoffrey C.; Ball, Joanna; Marsden, Jonathan F.; Ward, Nicholas S.; Di Lazzaro, Vincenzo; Greenwood, Richard G.; Rothwell, John C.

2013-01-01

Background Noninvasive cortical stimulation could represent an add-on treatment to enhance motor recovery after stroke. However, its clinical value, including anticipated size and duration of the treatment effects, remains largely unknown. Objective The authors designed a small semi-randomized clinical trial to explore whether long-lasting clinically important gains can be achieved by adding theta burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (TMS), to a rehabilitation program for the hand. Methods A total of 41 chronic stroke patients received excitatory TBS to the ipsilesional hemisphere or inhibitory TBS to the contralesional hemisphere in 2 centers; each active group was compared with a group receiving sham TBS. TBS was followed by physical therapy for 10 working days. Patients and therapists were blinded to the type of TBS. Primary outcome measures (9-hole Peg Test [9HPT], Jebsen Taylor Test [JTT], and grip and pinch-grip dynamometry) were assessed 4, 30, and 90 days post treatment. The clinically important difference was defined as 10% of the maximum score. Results There were no differences between the active treatment and sham groups in any of the outcome measures. All patients achieved small sustainable improvements—9HPT, 5% of maximum (confidence interval [CI] = 3%-7%); JTT, 5.7% (CI = 3%-8%); and grip strength, 6% (CI = 2%-10%)—all below the defined clinically important level. Conclusions Cortical stimulation did not augment the gains from a late rehabilitation program. The effect size anticipated by the authors was overestimated. These results can improve the design of future work on therapeutic uses of TMS. PMID:22412171

Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference.

PubMed

du Bois, Roland M; Weycker, Derek; Albera, Carlo; Bradford, Williamson Z; Costabel, Ulrich; Kartashov, Alex; Lancaster, Lisa; Noble, Paul W; Sahn, Steven A; Szwarcberg, Javier; Thomeer, Michiel; Valeyre, Dominique; King, Talmadge E

2011-05-01

The 6-minute-walk test (6MWT) is a practical and clinically meaningful measure of exercise tolerance with favorable performance characteristics in various cardiac and pulmonary diseases. Performance characteristics in patients with idiopathic pulmonary fibrosis (IPF) have not been systematically evaluated. To assess the reliability, validity, and responsiveness of the 6MWT and estimate the minimal clinically important difference (MCID) in patients with IPF. The study population included all subjects completing a 6MWT in a clinical trial evaluating interferon gamma-1b (n = 822). Six-minute walk distance (6MWD) and other parameters were measured at baseline and at 24-week intervals using a standardized protocol. Parametric and distribution-independent correlation coefficients were used to assess the strength of the relationships between 6MWD and measures of pulmonary function, dyspnea, and health-related quality of life. Both distribution-based and anchor-based methods were used to estimate the MCID. Comparison of two proximal measures of 6MWD (mean interval, 24 d) demonstrated good reliability (coefficient = 0.83; P < 0.001). 6MWD was weakly correlated with measures of physiologic function and health-related quality of life; however, values were consistently and significantly lower for patients with the poorest functional status, suggesting good construct validity. Importantly, change in 6MWD was highly predictive of mortality; a 24-week decline of greater than 50 m was associated with a fourfold increase in risk of death at 1 year (hazard ratio, 4.27; 95% confidence interval, 2.57- 7.10; P < 0.001). The estimated MCID was 24-45 m. The 6MWT is a reliable, valid, and responsive measure of disease status and a valid endpoint for clinical trials in IPF.

Health-related quality of life of coronary artery bypass grafting and percutaneous transluminal coronary artery angioplasty patients: 1-year follow-up.

PubMed

Kattainen, Eija; Sintonen, Harri; Kettunen, Raimo; Meriläinen, Pirkko

2005-01-01

The aim of the study was to compare the health-related quality of life (HRQoL) of patients undergoing coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) before the interventions and 6 and 12 months afterward, and to compare their HRQoL also with that of the general population. The sample (n = 615) consisted of consecutive coronary artery disease patients treated with elective CABG (n=432) or PTCA (n=183). The baseline data before the treatments were collected by structured interview, the follow-up data mainly by mailed self-administered questionnaires. HRQoL was measured by the 15D. For comparisons, the groups were standardized for differences in socioeconomic and clinical characteristics with a regression analysis. At baseline, the average 15D scores of the patient groups were 0.752 (95 percent confidence interval [CI], 0.743-0.761) in CABG and 0.730 (95 percent CI, 0.716-0.744) in PTCA. After standardization, the difference between the groups was statistically significant but not clinically important. These scores were significantly worse (statistically and clinically) than the score of 0.883 (95 percent CI, 0.871-0.879) in the general population sample matched with the gender and age distribution of the patients. By 6 months, the CABG and PTCA patients had experienced a statistically significant and clinically important improvement to 0.858 (95 percent CI, 0.844-0.872) and 0.824 (95 percent CI, 0.806-0.842), respectively. No significant change took place in either group from 6 to 12 months. Both CABG and PTCA produces an approximately similar, clinically important improvement in HRQoL in 1-year follow-up.

Teaching Medical Students the Important Connection between Communication and Clinical Reasoning

PubMed Central

Windish, Donna M; Price, Eboni G; Clever, Sarah L; Magaziner, Jeffrey L; Thomas, Patricia A

2005-01-01

Background Medical students are rarely taught how to integrate communication and clinical reasoning. Not understanding the relation between these skills may lead students to undervalue the connection between psychosocial and biomedical aspects of patient care. Objective To improve medical students' communication and clinical reasoning and their appreciation of how these skills interrelate in medical practice. Design In 2003, we conducted a randomized trial of a curricular intervention at Johns Hopkins University School of Medicine. In a 6-week course, participants learned communication and clinical reasoning skills in an integrative fashion using small group exercises with role-play, reflection and feedback through a structured iterative reflective process. Participants Second-year medical students. Measurements All students interviewed standardized patients who evaluated their communication skills in establishing rapport, data gathering and patient education/counseling on a 5-point scale (1=poor; 5=excellent). We assessed clinical reasoning through the number of correct problems listed and differential diagnoses generated and the Diagnostic Thinking Inventory. Students rated the importance of learning these skills in an integrated fashion. Results Standardized patients rated curricular students more favorably in establishing rapport (4.1 vs 3.9; P=.05). Curricular participants listed more psychosocial history items on their problem lists (65% of curricular students listing ≥1 item vs 44% of controls; P=.008). Groups did not differ significantly in other communication or clinical reasoning measures. Ninety-five percent of participants rated the integration of these skills as important. Conclusions Intervention students performed better in certain communication and clinical reasoning skills. These students recognized the importance of biomedical and psychosocial issues in patient care. Educators may wish to teach the integration of these skills early in medical training. PMID:16423099

Clinical applications of hallucinogens: A review.

PubMed

Garcia-Romeu, Albert; Kersgaard, Brennan; Addy, Peter H

2016-08-01

Hallucinogens fall into several different classes, as broadly defined by pharmacological mechanism of action, and chemical structure. These include psychedelics, entactogens, dissociatives, and other atypical hallucinogens. Although these classes do not share a common primary mechanism of action, they do exhibit important similarities in their ability to occasion temporary but profound alterations of consciousness, involving acute changes in somatic, perceptual, cognitive, and affective processes. Such effects likely contribute to their recreational use. However, a growing body of evidence indicates that these drugs may have therapeutic applications beyond their potential for abuse. This review will present data on several classes of hallucinogens with a particular focus on psychedelics, entactogens, and dissociatives, for which clinical utility has been most extensively documented. Information on each class is presented in turn, tracing relevant historical insights, highlighting similarities and differences between the classes from the molecular to the behavioral level, and presenting the most up-to-date information on clinically oriented research with these substances, with important ramifications for their potential therapeutic value. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Binaural hearing with electrical stimulation

PubMed Central

Kan, Alan; Litovsky, Ruth Y.

2014-01-01

Bilateral cochlear implantation is becoming a standard of care in many clinics. While much benefit has been shown through bilateral implantation, patients who have bilateral cochlear implants (CIs) still do not perform as well as normal hearing listeners in sound localization and understanding speech in noisy environments. This difference in performance can arise from a number of different factors, including the areas of hardware and engineering, surgical precision and pathology of the auditory system in deaf persons. While surgical precision and individual pathology are factors that are beyond careful control, improvements can be made in the areas of clinical practice and the engineering of binaural speech processors. These improvements should be grounded in a good understanding of the sensitivities of bilateral CI patients to the acoustic binaural cues that are important to normal hearing listeners for sound localization and speech in noise understanding. To this end, we review the current state-of-the-art in the understanding of the sensitivities of bilateral CI patients to binaural cues in electric hearing, and highlight the important issues and challenges as they relate to clinical practice and the development of new binaural processing strategies. PMID:25193553

Severity of Clinical Disease and Pathology in Ferrets Experimentally Infected with Influenza Viruses Is Influenced by Inoculum Volume

PubMed Central

Moore, Ian N.; Lamirande, Elaine W.; Paskel, Myeisha; Donahue, Danielle; Qin, Jing

2014-01-01

ABSTRACT Ferrets are a valuable model for influenza virus pathogenesis, virus transmission, and antiviral therapy studies. However, the contributions of the volume of inoculum administered and the ferret's respiratory tract anatomy to disease outcome have not been explored. We noted variations in clinical disease outcomes and the volume of inoculum administered and investigated these differences by administering two influenza viruses (A/California/07/2009 [H1N1 pandemic] and A/Minnesota/11/2010 [H3N2 variant]) to ferrets intranasally at a dose of 106 50% tissue culture infective doses in a range of inoculum volumes (0.2, 0.5, or 1.0 ml) and followed viral replication, clinical disease, and pathology over 6 days. Clinical illness and respiratory tract pathology were the most severe and most consistent when the viruses were administered in a volume of 1.0 ml. Using a modified micro-computed tomography imaging method and examining gross specimens, we found that the right main-stem bronchus was consistently larger in diameter than the left main-stem bronchus, though the latter was longer and straighter. These anatomic features likely influence the distribution of the inoculum in the lower respiratory tract. A 1.0-ml volume of inoculum is optimal for delivery of virus to the lower respiratory tract of ferrets, particularly when evaluation of clinical disease is desired. Furthermore, we highlight important anatomical features of the ferret lung that influence the kinetics of viral replication, clinical disease severity, and lung pathology. IMPORTANCE Ferrets are a valuable model for influenza virus pathogenesis, virus transmission, and antiviral therapy studies. Clinical disease in ferrets is an important parameter in evaluating the virulence of novel influenza viruses, and findings are extrapolated to virulence in humans. Therefore, it is highly desirable that the data from different laboratories be accurate and reproducible. We have found that, even when the same virus was administered at similar doses, different investigators reported a range of clinical disease outcomes, from asymptomatic infection to severe weight loss, ocular and nasal discharge, sneezing, and lethargy. We found that a wide range of inoculum volumes was used to experimentally infect ferrets, and we sought to determine whether the variations in disease outcome were the result of the volume of inoculum administered. These data highlight some less explored features of the model, methods of experimental infection, and clinical disease outcomes in a research setting. PMID:25187553

Lymph node micrometastasis in gastrointestinal tract cancer--a clinical aspect.

PubMed

Natsugoe, Shoji; Arigami, Takaaki; Uenosono, Yoshikazu; Yanagita, Shigehiro; Nakajo, Akihiro; Matsumoto, Masataka; Okumura, Hiroshi; Kijima, Yuko; Sakoda, Masahiko; Mataki, Yuko; Uchikado, Yasuto; Mori, Shinichiro; Maemura, Kosei; Ishigami, Sumiya

2013-10-01

Lymph node micrometastasis (LNM) can now be detected thanks to the development of various biological methods such as immunohistochemistry (IHC) and reverse transcription-polymerase chain reaction (RT-PCR). Although several reports have examined LNM in various carcinomas, including gastrointestinal (GI) cancer, the clinical significance of LNM remains controversial. Clinically, the presence of LNM is particularly important in patients without nodal metastasis on routine histological examination (pN0), because patients with pN0 but with LNM already in fact have metastatic potential. However, at present, several technical obstacles are impeding the detection of LNM using methods such as IHC or RT-PCR. Accurate evaluation should be carried out using the same antibody or primer and the same technique in a large number of patients. The clinical importance of the difference between LNM and isolated tumor cells (≤0.2 mm in diameter) will also be gradually clarified. It is important that the results of basic studies on LNM are prospectively introduced into the clinical field. Rapid diagnosis of LNM using IHC and RT-PCR during surgery would be clinically useful. Currently, minimally invasive treatments such as endoscopic submucosal dissection and laparoscopic surgery with individualized lymphadenectomy are increasingly being performed. Accurate diagnosis of LNM would clarify issues of curability and safety when performing such treatments. In the near future, individualized lymphadenectomy will develop based on the establishment of rapid, accurate diagnosis of LNM.

Community desires for an online health information strategy.

PubMed

Dart, Jared M; Gallois, Cindy

2010-11-01

To determine whether the community's attitudes to components of a community eHealth strategy differ across three different socioeconomic groups. A survey questionnaire was designed and implemented across three different communities. Paper-based surveys were left in community organisations and local health practices in a low socioeconomic community on the outskirts of Ipswich, Queensland (n = 262), a mid-high socioeconomic community in the western suburbs of Brisbane (n = 256) and at a local university (n = 200). Ascribed importance and comfort with proposed components of a community eHealth strategy. A community-oriented health website was perceived as useful in getting access to relevant health information. Those who were most comfortable with accessing online health information were those who were: experienced, had home internet access and were frequent internet users. The most important types of health information for the website were: information about the treatment of conditions, how to manage a chronic illness, how to stay healthy and patient clinical pathways. The low socioeconomic community had different information priorities – all categories were considered more important, particularly information about how the public system operates, local health support groups, and the roles of health professionals. Different communities have different information demands but there is a strong demand for information which empowers community members to take control of their own health and become active participants in their health care. Tools such as a community health portal and patient clinical pathways should become more available.

Gender and oral contraceptive steroids as determinants of drug glucuronidation: effects on clofibric acid elimination.

PubMed Central

Miners, J O; Robson, R A; Birkett, D J

1984-01-01

The disposition of clofibric acid, a drug metabolised largely by glucuronidation, was studied in eight males, eight females and eight females receiving oral contraceptive steroids (OCS). Clofibric acid plasma clearance was not significantly different in males compared to the control female group but was 48% greater (P less than 0.01) in women receiving OCS compared to non-pill using females. This difference was due to an alteration in clofibric acid metabolic clearance as there were no differences between the groups in clofibric acid free fraction. Along with previous data the results suggest that induction of drug glucuronidation by OCS may be of clinical importance, although any sex-related differences are unlikely to be of clinical significance. PMID:6487463

Using translational medicine to understand clinical differences between botulinum toxin formulations.

PubMed

Aoki, K R; Ranoux, D; Wissel, J

2006-12-01

When using botulinum toxin-based products, the physician must decide the optimal location and dose required to alleviate symptoms and improve the patient's quality of life. To deliver effective treatment, the physician needs to understand the importance of accurate target muscle selection and localization and the implications of each product's migration properties when diluted in different volumes. Pre-clinical mouse models of efficacy and safety have been utilized to compare local and distal muscle relaxation effects following defined intramuscular administration. Data from the model allow the products to be ranked based on their propensity for local efficacy versus their distal migration properties. Using standardized dilutions, the non-parallel dose-response curves for the various formulations demonstrate that they have different efficacy profiles. Distal effects were also noted at different treatment doses, which are reflected in the different safety and/or therapeutic margins. Based on these pre-clinical data, the safety and therapeutic margin rankings are ordered, largest to smallest, as BOTOX, Dysport and Myobloc. The results of subsequent clinical trials are variable and dose comparisons are inconclusive, thus supporting the regulatory position that the dose units of the individual preparations are unique and cannot be simply converted between products.

"They put you on your toes": Physical Therapists' Perceived Benefits from and Barriers to Supervising Students in the Clinical Setting.

PubMed

Davies, Robyn; Hanna, Elizabeth; Cott, Cheryl

2011-01-01

To identify the perceived benefits of and barriers to clinical supervision of physical therapy (PT) students. In this qualitative descriptive study, three focus groups and six key-informant interviews were conducted with clinical physical therapists or administrators working in acute care, orthopaedic rehabilitation, or complex continuing care. Data were coded and analyzed for common ideas using a constant comparison approach. Perceived barriers to supervising students tended to be extrinsic: time and space constraints, challenging or difficult students, and decreased autonomy or flexibility for the clinical physical therapists. Benefits tended to be intrinsic: teaching provided personal gratification by promoting reflective practice and exposing clinical educators to current knowledge. The culture of different health care institutions was an important factor in therapists' perceptions of student supervision. Despite different disciplines and models of supervision, there is considerable synchronicity in the issues reported by physical therapists and other disciplines. Embedding the value of clinical teaching in the institution, along with strong communication links among academic partners, institutions, and potential clinical faculty, may mitigate barriers and increase the commitment and satisfaction of teaching staff.

Appending Limited Clinical Data to an Administrative Database for Acute Myocardial Infarction Patients: The Impact on the Assessment of Hospital Quality.

PubMed

Hannan, Edward L; Samadashvili, Zaza; Cozzens, Kimberly; Jacobs, Alice K; Venditti, Ferdinand J; Holmes, David R; Berger, Peter B; Stamato, Nicholas J; Hughes, Suzanne; Walford, Gary

2016-05-01

Hospitals' risk-standardized mortality rates and outlier status (significantly higher/lower rates) are reported by the Centers for Medicare and Medicaid Services (CMS) for acute myocardial infarction (AMI) patients using Medicare claims data. New York now has AMI claims data with blood pressure and heart rate added. The objective of this study was to see whether the appended database yields different hospital assessments than standard claims data. New York State clinically appended claims data for AMI were used to create 2 different risk models based on CMS methods: 1 with and 1 without the added clinical data. Model discrimination was compared, and differences between the models in hospital outlier status and tertile status were examined. Mean arterial pressure and heart rate were both significant predictors of mortality in the clinically appended model. The C statistic for the model with the clinical variables added was significantly higher (0.803 vs. 0.773, P<0.001). The model without clinical variables identified 10 low outliers and all of them were percutaneous coronary intervention hospitals. When clinical variables were included in the model, only 6 of those 10 hospitals were low outliers, but there were 2 new low outliers. The model without clinical variables had only 3 high outliers, and the model with clinical variables included identified 2 new high outliers. Appending even a small number of clinical data elements to administrative data resulted in a difference in the assessment of hospital mortality outliers for AMI. The strategy of adding limited but important clinical data elements to administrative datasets should be considered when evaluating hospital quality for procedures and other medical conditions.

Proteogenomic Investigation of Strain Variation in Clinical Mycobacterium tuberculosis Isolates.

PubMed

Heunis, Tiaan; Dippenaar, Anzaan; Warren, Robin M; van Helden, Paul D; van der Merwe, Ruben G; Gey van Pittius, Nicolaas C; Pain, Arnab; Sampson, Samantha L; Tabb, David L

2017-10-06

Mycobacterium tuberculosis consists of a large number of different strains that display unique virulence characteristics. Whole-genome sequencing has revealed substantial genetic diversity among clinical M. tuberculosis isolates, and elucidating the phenotypic variation encoded by this genetic diversity will be of the utmost importance to fully understand M. tuberculosis biology and pathogenicity. In this study, we integrated whole-genome sequencing and mass spectrometry (GeLC-MS/MS) to reveal strain-specific characteristics in the proteomes of two clinical M. tuberculosis Latin American-Mediterranean isolates. Using this approach, we identified 59 peptides containing single amino acid variants, which covered ∼9% of all coding nonsynonymous single nucleotide variants detected by whole-genome sequencing. Furthermore, we identified 29 distinct peptides that mapped to a hypothetical protein not present in the M. tuberculosis H37Rv reference proteome. Here, we provide evidence for the expression of this protein in the clinical M. tuberculosis SAWC3651 isolate. The strain-specific databases enabled confirmation of genomic differences (i.e., large genomic regions of difference and nonsynonymous single nucleotide variants) in these two clinical M. tuberculosis isolates and allowed strain differentiation at the proteome level. Our results contribute to the growing field of clinical microbial proteogenomics and can improve our understanding of phenotypic variation in clinical M. tuberculosis isolates.

Reflecting on the essence of our problem-based learning discussions: the importance of faculty development and our continuous quest for applications of problem-based learning.

PubMed

Chan, Engle Angela

2009-05-01

While problem-based learning (PBL) is a teaching strategy to promote critical thinking, creativity and self-directedness in learning is very important. It is the meaning of the learning, with a contextual understanding, that marks the significance of this approach in our healthcare education. At the 2008 Kaohsiung Medical University International Conference and Workshop on PBL, the scholarly discourse on sharing empirical findings and practical experience with various aspects of PBL brought forth the importance of the teachers' continued learning about the meaning, the dynamics of the process, and the pragmatic details of PBL. This quest for a continuous learning and understanding about PBL parallels our search to extend the classroom PBL into students' clinical experience. The development of clinical teachers in the understanding of PBL was explored as part of their experiential learning in clinical teaching after their PBL workshops. While the clinical teachers who participated in the project appreciated the merits of clinical PBL, the complex balance between patient service and student teaching--in an unpredictable clinical setting--has led to the use of a simulated clinical environment with simulated patients. We also piloted PBL for interprofessional education of undergraduate students of nursing and social work. The ways we can adopt PBL in various settings with different intents will help prepare our healthcare graduates in meeting the challenges of our ever more complex healthcare systems, and the demands of holistic patient care.

HDGF: a novel jack-of-all-trades in cancer.

PubMed

Bao, Cihang; Wang, Jianbo; Ma, Wei; Wang, Xintong; Cheng, Yufeng

2014-12-01

HDGF is an important regulator of a broad range of cancer cell activities and plays important roles in cancer cell transformation, apoptosis, angiogenesis and metastasis. Such a divergent influence of HDGF on cancer cell activities derives from its multiple inter- and sub-cellular localizations where it interacts with a range of different binding partners. Interestingly, high levels of HDGF could be detected in patients' serum of some cancers. This review is focused on the role of HDGF in tumorigenesis and metastasis, and provides insight for application in clinical cancer therapy as well as its clinical implications as a prognostic marker in cancer progression.

Health-care sector and complementary medicine: practitioners' experiences of delivering acupuncture in the public and private sectors.

PubMed

Bishop, Felicity L; Amos, Nicola; Yu, He; Lewith, George T

2012-07-01

The aim was to identify similarities and differences between private practice and the National Health Service (NHS) in practitioners' experiences of delivering acupuncture to treat pain. We wished to identify differences that could affect patients' experiences and inform our understanding of how trials conducted in private clinics relate to NHS clinical practice. Acupuncture is commonly used in primary care for lower back pain and is recommended in the National Institute for Health and Clinical Excellence's guidelines. Previous studies have identified differences in patients' accounts of receiving acupuncture in the NHS and in the private sector. The major recent UK trial of acupuncture for back pain was conducted in the private sector. Semi-structured qualitative interviews were conducted with 16 acupuncturists who had experience of working in the private sector (n = 7), in the NHS (n =3), and in both the sectors (n = 6). The interviews lasted between 24 and 77 min (median=49 min) and explored acupuncturists' experiences of treating patients in pain. Inductive thematic analysis was used to identify similarities and differences across private practice and the NHS. The perceived effectiveness of acupuncture was described consistently and participants felt they did (or would) deliver acupuncture similarly in NHS and in private practice. In both the sectors, patients sought acupuncture as a last resort and acupuncturist-patient relationships were deemed important. Acupuncture availability differed across sectors: in the NHS it was constrained by Trust policies and in the private sector by patients' financial resources. There were greater opportunities for autonomous practice in the private sector and regulation was important for different reasons in each sector. In general, NHS practitioners had Western-focussed training and also used conventional medical techniques, whereas private practitioners were more likely to have Traditional Chinese training and to practise other complementary therapies in addition to acupuncture. Future studies should examine the impact of these differences on patients' clinical outcomes.

Patient reported outcomes in head and neck cancer: selecting instruments for quality of life integration in clinical protocols.

PubMed

Silveira, Augusta P; Gonçalves, Joaquim; Sequeira, Teresa; Ribeiro, Cláudia; Lopes, Carlos; Monteiro, Eurico; Pimentel, Francisco L

2010-10-31

Health Related Quality of Life has been used in medical research for more than twenty years, being progressively accepted during the last decade as an important patient reported outcome. Considering the multidimensional approach involved in Health Related Quality of Life assessment, instrument applicability and cultural adaptation must be tested for each population. In order to select the most appropriate instrument for Head and Neck cancer patients, two major Health Related Quality of Life specific questionnaires for Head and Neck cancer patients were compared. Conceptual differences, psychometric characteristics, scores, reliability, construct validity and sensitivity to symptomatology, tumour location, tumour size were analyzed. 102 consecutive Head and Neck cancer patients completed two different Health Related Quality of Life questionnaires: EORTC QLQ-C30 and its specific head and neck module QLQ-H&N35 and the Functional Assessment of Cancer Therapy Scales (FACT-H&N). Patients completed the questionnaires, immediately before consultation as a part of the routine evaluation. A greater variability was always found in the EORTC QLC-C30 questionnaire's scores for all comparable domains. Both instruments revealed a good internal consistency and demonstrated to be good tools to distinguish symptomatic patients. The EORTC questionnaires still demonstrated sensitivity to distinguish T3 and T4 staging. Conceptual differences and the psychometric characteristics are discussed. Our results suggest that these two instruments assess different aspects of Health Related Quality of Life - the questionnaires should be used separately and chosen according to the study objectives and methodology. This study emphases the importance in selecting the appropriate tool as a critical success factor in implementing routine Health Related Quality of Life assessment in clinical practice. This decision assumes particularly importance when utilization of results in real time and integration into clinical protocols are considered.

Animal Research on Nicotine Reduction: Current Evidence and Research Gaps.

PubMed

Smith, Tracy T; Rupprecht, Laura E; Denlinger-Apte, Rachel L; Weeks, Jillian J; Panas, Rachel S; Donny, Eric C; Sved, Alan F

2017-09-01

A mandated reduction in the nicotine content of cigarettes may improve public health by reducing the prevalence of smoking. Animal self-administration research is an important complement to clinical research on nicotine reduction. It can fill research gaps that may be difficult to address with clinical research, guide clinical researchers about variables that are likely to be important in their own research, and provide policy makers with converging evidence between clinical and preclinical studies about the potential impact of a nicotine reduction policy. Convergence between clinical and preclinical research is important, given the ease with which clinical trial participants can access nonstudy tobacco products in the current marketplace. Herein, we review contributions of preclinical animal research, with a focus on rodent self-administration, to the science of nicotine reduction. Throughout this review, we highlight areas where clinical and preclinical research converge and areas where the two differ. Preclinical research has provided data on many important topics such as the threshold for nicotine reinforcement, the likelihood of compensation, moderators of the impact of nicotine reduction, the impact of environmental stimuli on nicotine reduction, the impact of nonnicotine cigarette smoke constituents on nicotine reduction, and the impact of nicotine reduction on vulnerable populations. Special attention is paid to current research gaps including the dramatic rise in alternative tobacco products, including electronic nicotine delivery systems (ie, e-cigarettes). The evidence reviewed here will be critical for policy makers as well as clinical researchers interested in nicotine reduction. This review will provide policy makers and clinical researchers interested in nicotine reduction with an overview of the preclinical animal research conducted on nicotine reduction and the regulatory implications of that research. The review also highlights the utility of preclinical research for research questions related to nicotine reduction. © The Author 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Are There Clinical Implications of Racial Differences in HbA1c? A Difference, to Be a Difference, Must Make a Difference.

PubMed

Selvin, Elizabeth

2016-08-01

Studies that have compared HbA1c levels by race have consistently demonstrated higher HbA1c levels in African Americans than in whites. These racial differences in HbA1c have not been explained by measured differences in glycemia, sociodemographic factors, clinical factors, access to care, or quality of care. Recently, a number of nonglycemic factors and several genetic polymorphisms that operate through nonglycemic mechanisms have been associated with HbA1c Their distributions across racial groups and their impact on hemoglobin glycation need to be systematically explored. Thus, on the basis of evidence for racial differences in HbA1c, current clinical guidelines from the American Diabetes Association state: "It is important to take…race/ethnicity…into consideration when using the A1C to diagnose diabetes." However, it is not clear from the guidelines how this recommendation might be actualized. So, the critical question is not whether racial differences in HbA1c exist between African Americans and whites; the important question is whether the observed differences in HbA1c level are clinically meaningful. Therefore, given the current controversy, we provide a Point-Counterpoint debate on this issue. In the preceding point narrative, Dr. Herman provides his argument that the failure to acknowledge that HbA1c might be a biased measure of average glycemia and an unwillingness to rigorously investigate this hypothesis will slow scientific progress and has the potential to do great harm. In the counterpoint narrative below, Dr. Selvin argues that there is no compelling evidence for racial differences in the validity of HbA1c as a measure of hyperglycemia and that race is a poor surrogate for differences in underlying causes of disease risk.-William T. CefaluEditor in Chief, Diabetes Care. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials

PubMed Central

Kraemer, Helena C.; Epstein, Robert S.; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P.; Mcnulty, James; Reed, Shelby D.; Sanchez, Juan; Leon, Andrew C.

2013-01-01

Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials. PMID:23882433

Gender awareness among physicians--the effect of specialty and gender. A study of teachers at a Swedish medical school.

PubMed

Risberg, Gunilla; Hamberg, Katarina; Johansson, Eva E

2003-10-27

An important goal for medical education today is professional development including gender equality and awareness of gender issues. Are medical teachers prepared for this task? We investigated gender awareness among physician teachers, expressed as their attitudes towards the role of gender in professional relationships, and how it varied with physician gender and specialty. We discuss how this might be related to the gender climate and sex segregation in different specialties. Questionnaires were sent to all 468 specialists in the clinical departments and in family medicine, who were engaged in educating medical students at a Swedish university. They were asked to rate, on visual analogue scales, the importance of physician and patient gender in consultation, of preceptor and student gender in clinical tutoring and of physician gender in other professional encounters. Differences between family physicians, surgical, and non-surgical hospital doctors, and between women and men were estimated by chi-2 tests and multivariate logistic regression analyses. The response rate was 65 %. There were differences between specialty groups in all investigated areas mainly due to disparities among men. The odds for a male family physician to assess gender important were three times higher, and for a male non-surgical doctor two times higher when compared to a male surgical doctor. Female teachers assessed gender important to a higher degree than men. Among women there were no significant differences between specialty groups. There was an interaction between physician teachers' gender and specialty as to whether they identified gender as important in professional relationships. Male physicians, especially from the surgical group, assessed gender important to a significantly lower degree than female physicians. Physicians' degree of gender awareness may, as one of many factors, affect working climate and the distribution of women and men in different specialties. Therefore, to improve working climate and reduce segregation we suggest efforts to increase gender awareness among physicians, for example educational programs where continuous reflections about gender attitudes are encouraged.

Lymph node metastasis in melanoma: a debate on the significance of nodal metastases, conditional survival analysis and clinical trials.

PubMed

Faries, Mark B; Han, Dale; Reintgen, Michael; Kerivan, Lauren; Reintgen, Douglas; Caracò, Corrado

2018-05-18

While there is no doubt that regional lymph node metastases are an enormously important factor in melanoma staging and treatment, the biology behind this significance and its precise implications for treatment planning have been a leading controversy in melanoma and other solid tumors for over a century. Recent clinical data, including data from prospective randomized clinical trials have refined our understanding of the process of nodal metastases and the advantages and disadvantages of different clinical management strategies. This review presents two points of view in this debate and discusses the results of new data analyses as well as pivotal clinical trials informing the discussion.

The intelligent clinical laboratory as a tool to increase cancer care management productivity.

PubMed

Mohammadzadeh, Niloofar; Safdari, Reza

2014-01-01

Studies of the causes of cancer, early detection, prevention or treatment need accurate, comprehensive, and timely cancer data. The clinical laboratory provides important cancer information needed for physicians which influence clinical decisions regarding treatment, diagnosis and patient monitoring. Poor communication between health care providers and clinical laboratory personnel can lead to medical errors and wrong decisions in providing cancer care. Because of the key impact of laboratory information on cancer diagnosis and treatment the quality of the tests, lab reports, and appropriate lab management are very important. A laboratory information management system (LIMS) can have an important role in diagnosis, fast and effective access to cancer data, decrease redundancy and costs, and facilitate the integration and collection of data from different types of instruments and systems. In spite of significant advantages LIMS is limited by factors such as problems in adaption to new instruments that may change existing work processes. Applications of intelligent software simultaneously with existing information systems, in addition to remove these restrictions, have important benefits including adding additional non-laboratory-generated information to the reports, facilitating decision making, and improving quality and productivity of cancer care services. Laboratory systems must have flexibility to change and have the capability to develop and benefit from intelligent devices. Intelligent laboratory information management systems need to benefit from informatics tools and latest technologies like open sources. The aim of this commentary is to survey application, opportunities and necessity of intelligent clinical laboratory as a tool to increase cancer care management productivity.

Epidemiology and control of schistosomiasis: present situation and priorities for further research. Scientific Working Group on Schistosomiasis.

PubMed

1978-01-01

The article highlights specific aspects of the epidemiology of schistosomiasis where insufficient data are available on which to base appropriate control strategies. Emphasis is placed on the part that immunological techniques might play in improving the baseline epidemiological data. A study of acquired resistance to the disease is also important in relation to epidemiology and control. The clinical manifestations of the disease vary in different areas and further study of the relation between the clinical and pathological manifestations are therefore required. In relation to the intermediate host, the main priority for research concerns the definition of the location and time-patterns of transmission foci within any particular area: variations in transmission are of particular importance in relation to man-made water resources. Although chemotherapy will play an increasing role in control, its importance will depend on local conditions: coordinated and standardized trials are required of chemotherapeutic agents in different regions and in various defined groups of subjects. The effects of chemotherapy on immunity to reinfection and on immunopathology also require study. With all types of snail control-chemical, ecological, and biological-cost-effectiveness aspects are important. With chemicals, it is important to bear in mind other possible effects on the environment. In the field of water supplies and sanitation, several aspects are important in relation to schistosomiasis transmission and community involvement should be encouraged.

Defining Pathways for Development of Disease-Modifying Therapies in Children With Type 1 Diabetes: A Consensus Report

PubMed Central

Wherrett, Diane K.; Chiang, Jane L.; Delamater, Alan M.; DiMeglio, Linda A.; Gitelman, Stephen E.; Gottlieb, Peter A.; Herold, Kevan C.; Lovell, Daniel J.; Orchard, Trevor J.; Ryan, Christopher M.; Schatz, Desmond A.; Wendler, David S.

2015-01-01

Emerging data suggest that type 1 diabetes is a more aggressive disease in children than in adults, with important differences in pathophysiology and clinical course. Therefore, the efficacy of disease-modifying therapies may be different in the two populations. Understanding the developmental and regulatory pathways for type 1 diabetes–modifying therapies in children will enable industry, academia, funders, advocacy groups, and regulators to translate new science to clinical care. This consensus report characterizes the fundamental differences in type 1 diabetes between children and adults and proposes a thoughtful approach to better understand the development and regulatory pathways for type 1 diabetes therapies. PMID:26404927

Common Sports-Related Infections: A Review on Clinical Pictures, Management and Time to Return to Sports

PubMed Central

Ahmadinejad, Zahra; Alijani, Neda; Mansori, Sedigeh; Ziaee, Vahid

2014-01-01

There is a relationship between exercise and changes in immunity. So athletes are prone to different medical problems such as injuries and infections. Infection is an important medical problem which could be a reason for athletes’ absence from training. The relationship between physical activity and immune system, characteristics of different types of infections in athletes with emphasis on special clinical presentations or complications, time to return to physical activity and training and strategies to prevent development and transmission of infections in athletes or physically active people are the main topics of this review. PMID:24868426

Common sports-related infections: a review on clinical pictures, management and time to return to sports.

PubMed

Ahmadinejad, Zahra; Alijani, Neda; Mansori, Sedigeh; Ziaee, Vahid

2014-03-01

There is a relationship between exercise and changes in immunity. So athletes are prone to different medical problems such as injuries and infections. Infection is an important medical problem which could be a reason for athletes' absence from training. The relationship between physical activity and immune system, characteristics of different types of infections in athletes with emphasis on special clinical presentations or complications, time to return to physical activity and training and strategies to prevent development and transmission of infections in athletes or physically active people are the main topics of this review.

Tumor-infiltrating T lymphocytes improve clinical outcome of therapy-resistant neuroblastoma.

PubMed

Mina, Marco; Boldrini, Renata; Citti, Arianna; Romania, Paolo; D'Alicandro, Valerio; De Ioris, Maretta; Castellano, Aurora; Furlanello, Cesare; Locatelli, Franco; Fruci, Doriana

2015-09-01

Neuroblastoma grows within an intricate network of different cell types including epithelial, stromal and immune cells. The presence of tumor-infiltrating T cells is considered an important prognostic indicator in many cancers, but the role of these cells in neuroblastoma remains to be elucidated. Herein, we examined the relationship between the type, density and organization of infiltrating T cells and clinical outcome within a large collection of neuroblastoma samples by quantitative analysis of immunohistochemical staining. We found that infiltrating T cells have a prognostic value greater than, and independent of, the criteria currently used to stage neuroblastoma. A variable in situ structural organization and different concurrent infiltration of T-cell subsets were detected in tumors with various outcomes. Low-risk neuroblastomas were characterized by a higher number of proliferating T cells and a more structured T-cell organization, which was gradually lost in tumors with poor prognosis. We defined an immunoscore based on the presence of CD3 + , CD4 + and CD8 + infiltrating T cells that associates with favorable clinical outcome in MYCN-amplified tumors, improving patient survival when combined with the v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) status. These findings support the hypothesis that infiltrating T cells influence the behavior of neuroblastoma and might be of clinical importance for the treatment of patients.

Intimate Partner Violence Screening and Response: Policies and Procedures Across Health Care Facilities.

PubMed

Williams, Jessica R; Halstead, Valerie; Salani, Deborah; Koermer, Natasha

2016-01-01

This study examines policies and procedures for identifying and responding to intimate partner violence (IPV) among different types of health care settings. This epidemiologic, cross-sectional, observational study design collected data from June 2014 to January 2015 through a telephone questionnaire from a stratified random sample of 288 health care facilities in Miami-Dade County, Florida. An overall response rate of 76.2% was achieved from 72 primary care clinics, 93 obstetrics/gynecology clinics, 106 pediatric clinics, and 17 emergency departments (EDs). There is a general awareness of the importance of IPV screening with 78.1% of facilities (95% CI, 73.9%-82.3%) reporting some type of IPV screening procedures. Wide variation exists, however, in how practices are implemented, with only 35.3% of facilities (95% CI, 29.5%-41.1%) implementing multicomponent, comprehensive IPV screening and response programs. Differences were also observed by setting with EDs reporting the most comprehensive programs. This study yields important empirical information regarding the extent to which IPV screening and response procedures are currently being implemented in both clinic and acute health care settings along with areas where improvements are needed. Copyright © 2016 Jacobs Institute of Women's Health. Published by Elsevier Inc. All rights reserved.

Fermentation products in the cystic fibrosis airways induce aggregation and dormancy-associated expression profiles in a CF clinical isolate of Pseudomonas aeruginosa

PubMed Central

Phan, Joann; Gallagher, Tara; Oliver, Andrew; England, Whitney E; Whiteson, Katrine

2018-01-01

Abstract Pseudomonas aeruginosa is a well-known dominant opportunistic pathogen in cystic fibrosis (CF) with a wide range of metabolic capacities. However, P. aeruginosa does not colonize the airways alone, and benefits from the metabolic products of neighboring cells—especially volatile molecules that can travel between different parts of the airways easily. Here, we present a study that investigates the metabolic, gene expression profiles and phenotypic responses of a P. aeruginosa clinical isolate to fermentation products lactic acid and 2,3-butanediol, metabolites that are produced by facultative anaerobic members of the CF polymicrobial community and potential biomarkers of disease progression. Although previous studies have successfully investigated the metabolic and transcriptional profiles of P. aeruginosa, most have used common lab reference strains that may differ in important ways from clinical isolates. Using transcriptomics and metabolomics with gas chromatography time of flight mass spectrometry, we observe that fermentation products induce pyocyanin production along with the expression of genes involved in P. aeruginosa amino acid utilization, dormancy and aggregative or biofilm modes of growth. These findings have important implications for how interactions within the diverse CF microbial community influence microbial physiology, with potential clinical consequences. PMID:29617986

Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice.

PubMed

Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

2010-05-01

This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional community, and features of clinical practice such as private versus public practice as well as local management policies. This review brings together the different strands of knowledge concerning non-clinical influences on clinical decision-making. This aspect of decision-making may be the biggest obstacle to the reality of practising evidence-based medicine. It needs to be understood in order to develop clinical strategies that will facilitate the practice of evidence-based medicine.

Students' perception of the psycho-social clinical learning environment: an evaluation of placement models.

PubMed

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

2006-10-01

Nursing is a practice based discipline. A supportive environment has been identified as important for the transfer of learning in the clinical context. The aim of the paper was to assess undergraduate nurses' perceptions of the psychosocial characteristics of clinical learning environments within three different clinical placement models. Three hundred and eight-nine undergraduate nursing students rated their perceptions of the psycho-social learning environment using a Clinical Learning Environment Inventory. There were 16 respondents in the Preceptor model category, 269 respondents in the Facilitation model category and 114 respondents in the clinical education unit model across 25 different clinical areas in one tertiary facility. The most positive social climate was associated with the preceptor model. On all subscales the median score was rated higher than the two other models. When clinical education units were compared with the standard facilitation model the median score was rated higher in all of the subscales in the Clinical Learning Environment Inventory. These results suggest that while preceptoring is an effective clinical placement strategy that provides psycho-social support for students, clinical education units that are more sustainable through their placement of greater numbers of students, can provide greater psycho-social support for students than traditional models.

Features of Brazilian spotted fever in two different endemic areas in Brazil.

PubMed

Angerami, Rodrigo N; Câmara, Milena; Pacola, Márcia R; Rezende, Regina C M; Duarte, Raquel M R; Nascimento, Elvira M M; Colombo, Silvia; Santos, Fabiana C P; Leite, Ruth M; Katz, Gizelda; Silva, Luiz J

2012-12-01

Brazilian spotted fever (BSF) caused by Rickettsia rickettsii is the most important rickettsiosis and the only reportable tick-borne disease in Brazil. In Brazil, the hard tick Amblyomma cajennense is the most important BSF vector; however, in São Paulo State, A. aureolatum was also recognized as a vector species in remaining Atlantic forest areas near the metropolitan area of São Paulo city. We analyzed clinical and epidemiological features of BSF cases from two distinct areas where A. cajennense (Area 1) and A. aureolatum (Area 2) are the incriminated vectors. The clinical features demonstrate the same severity pattern of BSF in both endemic areas. Differences in seasonality, patient characteristics (median age and gender), and epidemiological risk factors (animals host contact and vegetation characteristics) were observed and possibly could be attributed to the characteristics of each vector and their typical biological cycle (hosts and environment). Copyright © 2012 Elsevier GmbH. All rights reserved.

Androgens: basic biology and clinical implication.

PubMed

Orwoll, E S

2001-10-01

Although androgens have been considered essential modulators of bone biology in men, recent studies have indicated that estrogen may have an important, if not dominant, role. Nevertheless, there is strong evidence that androgens have independent skeletal actions. Nonaromatizable androgens influence a variety of aspects of bone cell biology and are capable of modulating bone remodeling and bone mass. It appears that androgens are particularly important in the control of periosteal bone formation, an effect that might underlie the gender difference in bone size. Alterations in androgen receptor function affect bone metabolism, and new information suggests that androgens modulate receptor homeostasis. The clinical implications of androgen effects, and how they interact with those of estrogens, are somewhat unclear. It is likely that overall bone homeostasis and gender differences depend on a combination of androgenic and estrogenic actions. Androgens may well provide advantages in the prevention and therapy of metabolic bone disorders in both men and women.

Crowdsourcing in biomedicine: challenges and opportunities

PubMed Central

Khare, Ritu; Good, Benjamin M.; Leaman, Robert; Su, Andrew I.

2016-01-01

The use of crowdsourcing to solve important but complex problems in biomedical and clinical sciences is growing and encompasses a wide variety of approaches. The crowd is diverse and includes online marketplace workers, health information seekers, science enthusiasts and domain experts. In this article, we review and highlight recent studies that use crowdsourcing to advance biomedicine. We classify these studies into two broad categories: (i) mining big data generated from a crowd (e.g. search logs) and (ii) active crowdsourcing via specific technical platforms, e.g. labor markets, wikis, scientific games and community challenges. Through describing each study in detail, we demonstrate the applicability of different methods in a variety of domains in biomedical research, including genomics, biocuration and clinical research. Furthermore, we discuss and highlight the strengths and limitations of different crowdsourcing platforms. Finally, we identify important emerging trends, opportunities and remaining challenges for future crowdsourcing research in biomedicine. PMID:25888696

The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures.

PubMed

Walenkamp, Monique M J; de Muinck Keizer, Robert-Jan; Goslings, J Carel; Vos, Lara M; Rosenwasser, Melvin P; Schep, Niels W L

2015-10-01

The Patient-rated Wrist Evaluation (PRWE) is a commonly used instrument in upper extremity surgery and in research. However, to recognize a treatment effect expressed as a change in PRWE, it is important to be aware of the minimum clinically important difference (MCID) and the minimum detectable change (MDC). The MCID of an outcome tool like the PRWE is defined as the smallest change in a score that is likely to be appreciated by a patient as an important change, while the MDC is defined as the smallest amount of change that can be detected by an outcome measure. A numerical change in score that is less than the MCID, even when statistically significant, does not represent a true clinically relevant change. To our knowledge, the MCID and MDC of the PRWE have not been determined in patients with distal radius fractures. We asked: (1) What is the MCID of the PRWE score for patients with distal radius fractures? (2) What is the MDC of the PRWE? Our prospective cohort study included 102 patients with a distal radius fracture and a median age of 59 years (interquartile range [IQR], 48-66 years). All patients completed the PRWE questionnaire during each of two separate visits. At the second visit, patients were asked to indicate the degree of clinical change they appreciated since the previous visit. Accordingly, patients were categorized in two groups: (1) minimally improved or (2) no change. The groups were used to anchor the changes observed in the PRWE score to patients' perspectives of what was clinically important. We determined the MCID using an anchor-based receiver operator characteristic method. In this context, the change in the PRWE score was considered a diagnostic test, and the anchor (minimally improved or no change as noted by the patients from visit to visit) was the gold standard. The optimal receiver operator characteristic cutoff point calculated with the Youden index reflected the value of the MCID. In our study, the MCID of the PRWE was 11.5 points. The area under the curve was 0.54 (95% CI, 0.37-0.70) for the pain subscale and 0.71 (95% CI, 0.57-0.85) for the function subscale. We determined the MDC to be 11.0 points. We determined the MCID of the PRWE score for patients with distal radius fractures using the anchor-based approach and verified that the MDC of the PRWE was sufficiently small to detect our MCID. We recommend using an improvement on the PRWE of more than 11.5 points as the smallest clinically relevant difference when evaluating the effects of treatments and when performing sample-size calculations on studies of distal radius fractures.

Assessing clinical significance of treatment outcomes using the DASS-21.

PubMed

Ronk, Fiona R; Korman, James R; Hooke, Geoffrey R; Page, Andrew C

2013-12-01

Standard clinical significance classifications are based on movement between the "dysfunctional" and "functional" distributions; however, this dichotomy ignores heterogeneity within the "dysfunctional" population. Based on the methodology described by Tingey, Lambert, Burlingame, and Hansen (1996), the present study sought to present a 3-distribution clinical significance model for the 21-item version of the Depression Anxiety Stress Scales (DASS-21; P. F. Lovibond & Lovibond, 1995) using data from a normative sample (n = 2,914), an outpatient sample (n = 1,000), and an inpatient sample (n = 3,964). DASS-21 scores were collected at pre- and post-treatment for both clinical samples, and patients were classified into 1 of 5 categories based on whether they had made a reliable change and whether they had moved into a different functional range. Evidence supported the validity of the 3-distribution model for the DASS-21, since inpatients who were classified as making a clinically significant change showed lower symptom severity, higher perceived quality of life, and higher clinician-rated functioning than those who did not make a clinically significant change. Importantly, results suggest that the new category of recovering is an intermediate point between recovered and making no clinically significant change. Inpatients and outpatients have different treatment goals and therefore use of the concept of clinical significance needs to acknowledge differences in what constitutes a meaningful change. (c) 2013 APA, all rights reserved.

How healthcare states matter: comparing the introduction of clinical standards in Britain and Germany.

PubMed

Burau, Viola; Fenton, Laura

2009-01-01

This paper aims to identify variation in the introduction of New Public Management reforms in healthcare and how this variation is related to country-specific healthcare states. The analysis uses the introduction of clinical standards in Britain and Germany as cases. The two countries are characterised by interesting differences in relation to the institutional set-up of healthcare states and as such present ideal cases to explore the specific ways of how healthcare states filter clinical standards as tools of a generic managerialism. Both countries have introduced clinical standards but, importantly, the substantive nature of clinical standards differs, reflecting differences in initial institutional conditions. More specifically, in Britain clinical standards have taken the form of two parallel policies, which strengthen hierarchy-based governing and redefine professional self-regulation. In Germany, by contrast, clinical standards come in one single policy, which strengthens the hybrid of network- and hierarchy-based governing and to some extent also pure hierarchy-based forms of governing. First, with its cross-country comparative focus, the analysis is able to identify systematic variations across healthcare states and the specific ways in which they impact on the introduction of New Public Management. Second, with its focus on clinical standards, the analysis deals with the governance of medical practice as one of the central areas of healthcare states.

Atrial fibrillation in the Middle East: unmapped, underdiagnosed, undertreated.

PubMed

Al-Shamkhani, Warkaa; Ayetey, Harold; Lip, Gregory Y H

2018-05-01

Atrial fibrillation (AF) is the commonest persistent cardiac arrhythmia with an estimated incidence rate of between 1.5-2% and an important cause of strokes. Few epidemiological studies and clinical trials on the management of AF have been conducted outside Europe and North America. These gaps in our understanding of AF likely lead to sub-optimal management of patients with AF in the rest of the world. Areas covered: We discuss the epidemiology, treatment and clinical outcomes for AF in the Middle East after systematic review of published work for AF from the Middle East. We also discuss important clinical trials on AF conducted in the West in the same period to help contextualize our findings. Expert commentary: The few available Middle East studies suggest important epidemiological differences between Middle Eastern and Western AF populations. In particular, the Middle Eastern AF population is younger and have more co-morbidities than patients in the West. We find that significant numbers of moderate to high risk patients with AF are either undertreated or untreated placing them at increased risk of complications such as stroke. More studies in the Middle Eastern population are required to aid the development of region-specific clinical guidelines to improve patient care.

Molecular genetics made simple

PubMed Central

Kassem, Heba Sh.; Girolami, Francesca; Sanoudou, Despina

2012-01-01

Abstract Genetics have undoubtedly become an integral part of biomedical science and clinical practice, with important implications in deciphering disease pathogenesis and progression, identifying diagnostic and prognostic markers, as well as designing better targeted treatments. The exponential growth of our understanding of different genetic concepts is paralleled by a growing list of genetic terminology that can easily intimidate the unfamiliar reader. Rendering genetics incomprehensible to the clinician however, defeats the very essence of genetic research: its utilization for combating disease and improving quality of life. Herein we attempt to correct this notion by presenting the basic genetic concepts along with their usefulness in the cardiology clinic. Bringing genetics closer to the clinician will enable its harmonious incorporation into clinical care, thus not only restoring our perception of its simple and elegant nature, but importantly ensuring the maximal benefit for our patients. PMID:25610837

What makes a good clinical student and teacher? An exploratory study.

PubMed

Goldie, John; Dowie, Al; Goldie, Anne; Cotton, Phil; Morrison, Jill

2015-03-10

What makes a good clinical student is an area that has received little coverage in the literature and much of the available literature is based on essays and surveys. It is particularly relevant as recent curricular innovations have resulted in greater student autonomy. We also wished to look in depth at what makes a good clinical teacher. A qualitative approach using individual interviews with educational supervisors and focus groups with senior clinical students was used. Data was analysed using a "framework" technique. Good clinical students were viewed as enthusiastic and motivated. They were considered to be proactive and were noted to be visible in the wards. They are confident, knowledgeable, able to prioritise information, flexible and competent in basic clinical skills by the time of graduation. They are fluent in medical terminology while retaining the ability to communicate effectively and are genuine when interacting with patients. They do not let exam pressure interfere with their performance during their attachments. Good clinical teachers are effective role models. The importance of teachers' non-cognitive characteristics such as inter-personal skills and relationship building was particularly emphasised. To be effective, teachers need to take into account individual differences among students, and the communicative nature of the learning process through which students learn and develop. Good teachers were noted to promote student participation in ward communities of practice. Other members of clinical communities of practice can be effective teachers, mentors and role models. Good clinical students are proactive in their learning; an important quality where students are expected to be active in managing their own learning. Good clinical students share similar characteristics with good clinical teachers. A teacher's enthusiasm and non-cognitive abilities are as important as their cognitive abilities. Student learning in clinical settings is a collective responsibility. Our findings could be used in tutor training and for formative assessment of both clinical students and teachers. This may promote early recognition and intervention when problems arise.

Clinical encounters between nurses and First Nations women in a Western Canadian hospital.

PubMed

Browne, Annette J

2007-05-01

Based on findings from an ethnographic study, this paper explores the sociopolitical context of nurses' encounters with First Nations women in a Western Canadian hospital. Data were collected using in-depth interviews and participant observation of clinical encounters involving nurses and First Nations women who were in-patients in the hospital. Four themes in the data are discussed: relating across presumed "cultural differences"; constructing the Other; assumptions influencing clinical practice; and responding to routine patient requests. The findings illustrate how discourses and assumptions about Aboriginal people, culture, and presumed differences can become interwoven into routine clinical encounters. These results highlight the importance of analyzing health-care encounters in light of the wider sociopolitical and historical forces that give rise to racialization, culturalism and Othering, and underscore the need for critical awareness of these issues among nurses and other heath-care providers.

Configurations of leadership practices in hospital units.

PubMed

Meier, Ninna

2015-01-01

The purpose of this paper is to explore how leadership is practiced across four different hospital units. The study is a comparative case study of four hospital units, based on detailed observations of the everyday work practices, interactions and interviews with ten interdisciplinary clinical managers. Comparing leadership as configurations of practices across four different clinical settings, the author shows how flexible and often shared leadership practices were embedded in and central to the core clinical work in all units studied here, especially in more unpredictable work settings. Practices of symbolic work and emotional support to staff were particularly important when patients were severely ill. Based on a study conducted with qualitative methods, these results cannot be expected to apply in all clinical settings. Future research is invited to extend the findings presented here by exploring leadership practices from a micro-level perspective in additional health care contexts: particularly the embedded and emergent nature of such practices. This paper shows leadership practices to be primarily embedded in the clinical work and often shared across organizational or professional boundaries. This paper demonstrated how leadership practices are embedded in the everyday work in hospital units. Moreover, the analysis shows how configurations of leadership practices varied in four different clinical settings, thus contributing with contextual accounts of leadership as practice, and suggested "configurations of practice" as a way to carve out similarities and differences in leadership practices across settings.

Progress in defining clinically meaningful changes for clinical trials in nonrenal manifestations of SLE disease activity.

PubMed

Choi, Chan-Bum; Liang, Matthew H; Bae, Sang-Cheol

2016-01-06

Since the 2002 Dusseldorf meeting, one new agent, Benlysta, has been approved by the US Food and Drug Administration for systemic lupus erythematosus. Experiences from the field in conducting trials of all the agents tested during this period have provided valuable practical insights. There has been incremental progress in defining the minimal clinically important difference (MCID) of key disease manifestations and the view is largely that of the health care providers and not that of the person suffering the disease. This basic methodological work on the MCID should improve the efficiency and the clinical relevance of future trials and their design.

Utility of Bacillary Index in Slit Skin Smears in Correlation with Clinical and Histopathological Alterations in Hansen's Disease: An Attempt to Revive a Simple Useful Procedure.

PubMed

Premalatha, P; Renuka, I V; Meghana, A; Devi, S I; Charyulu, Pavk; Sampoorna, G

2016-01-01

Leprosy, a relatively common chronic contagious disease having diverse modes of clinical presentation, can mimic a variety of unrelated diseases. For proper and adequate treatment, the diagnosis must be made accurately with subtyping which should be done with the help of bacillary index, histopathological features, and clinical correlation. This is extremely important in patient care as paucibacillary and multibacillary types have different modes of treatment. Our aim is to categorize leprosy into various types based on bacillary index, morphological findings both in slit skin smears, and biopsy along with clinical correlation.

Correlations of fatty acid supplementation, aeroallergens, shampoo, and ear cleanser with multiple parameters in pruritic dogs.

PubMed

Nesbitt, Gene H; Freeman, Lisa M; Hannah, Steven S

2004-01-01

Seventy-two pruritic dogs were fed one of four diets controlled for n-6:n-3 fatty acid ratios and total dietary intake of fatty acids. Multiple parameters were evaluated, including clinical and cytological findings, aeroallergen testing, microbial sampling techniques, and effects of an anti-fungal/antibacterial shampoo and ear cleanser. Significant correlations were observed between many clinical parameters, anatomical sampling sites, and microbial counts when data from the diet groups was combined. There were no statistically significant differences between individual diets for any of the clinical parameters. The importance of total clinical management in the control of pruritus was demonstrated.

"I Was Told That My First Duty Was to Forget Physiology, Which Had No Relation to Medicine"

ERIC Educational Resources Information Center

Walsh, Kieran

2016-01-01

There has been much recent commentary on integration in health care professional education. This commentary is of importance to physiology education as integration often touches on integration between preclinical and clinical sciences. There are different forms of integration, from horizontal to vertical to spiral, and different theories underpin…

The NEO-FFI in Multiple Sclerosis: Internal Consistency, Factorial Validity, and Correspondence between Self and Informant Reports

ERIC Educational Resources Information Center

Schwartz, Eben S.; Chapman, Benjamin P.; Duberstein, Paul R.; Weinstock-Guttman, Bianca; Benedict, Ralph H. B.

2011-01-01

Personality assessment is a potentially important component of clinical and empirical work with neurological patients because (a) individual differences in personality may be associated with different neurological outcomes and (b) central nervous system changes may give rise to alteration in personality. For personality assessment to be useful to…

Do Black and White Youths Differ in Levels of Psychopathic Traits? A Meta-Analysis of the Psychopathy Checklist Measures

ERIC Educational Resources Information Center

McCoy, Wendy K.; Edens, John F.

2006-01-01

Putative ethnic group differences in various forms of psychopathology may have important theoretical, clinical, and policy implications. Recently, it has been argued that individuals of African descent are more likely to be psychopathic than those of European descent (R. Lynn, 2002). Preliminary evidence from the Psychopathy Checklist: Youth…

Clinical differences in patients with mitochondriocytopathies due to nuclear versus mitochondrial DNA mutations.

PubMed

Rubio-Gozalbo, M E; Dijkman, K P; van den Heuvel, L P; Sengers, R C; Wendel, U; Smeitink, J A

2000-01-01

Defects in oxidative phosphorylation (OXPHOS) are genetically unique because the different components involved in this process, respiratory chain enzyme complexes (I, III, and IV) and complex V, are encoded by nuclear and mitochondrial genome. The objective of the study was to assess whether there are clinical differences in patients suffering from OXPHOS defects caused by nuclear or mitochondrial DNA (mtDNA) mutations. We studied 16 families with > or = two siblings with a genetically established OXPHOS deficiency, four due to a nuclear gene mutation and 12 due to a mtDNA mutation. Siblings with a nuclear gene mutation showed very similar clinical pictures that became manifest in the first years (ranging from first months to early childhood). There was a severe progressive course. Seven of the eight children died in their first decade. Conversely, siblings with a mtDNA mutation had clinical pictures that varied from almost alike to very distinct. They became symptomatic at an older age (ranging from childhood to adulthood), with the exception of defects associated with Leigh or Leigh-like phenotype. The clinical course was more gradual and relatively less severe; four of the 26 patients died, one in his second year, another in her second decade and two in their sixth decade. There are differences in age at onset, severity of clinical course, outcome, and intrafamilial variability in patients affected of an OXPHOS defect due to nuclear or mtDNA mutations. Patients with nuclear mutations become symptomatic at a young age, and have a severe clinical course. Patients with mtDNA mutations show a wider clinical spectrum of age at onset and severity. These differences may be of importance regarding the choice of which genome to study in affected patients as well as with respect to genetic counseling. Copyright 2000 Wiley-Liss, Inc.

Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review.

PubMed

Saragiotto, Bruno T; Maher, Christopher G; Yamato, Tiê P; Costa, Leonardo O P; Costa, Luciola C Menezes; Ostelo, Raymond W J G; Macedo, Luciana G

2016-08-15

A systematic review. The aim of this review was to evaluate the effectiveness of motor control exercise (MCE) in patients with nonspecific low back pain (LBP). MCE is a common form of exercise used for managing LBP. MCE focuses on the activation of the deep trunk muscles and targets the restoration of control and coordination of these muscles, progressing to more complex and functional tasks integrating the activation of deep and global trunk muscles. We conducted electronic searches of CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers from their inception up to April 2015. Two independent review authors screened the search results, assessed risk of bias, and extracted the data. A third reviewer resolved any disagreement. We included randomized controlled trials comparing MCE with no treatment, another treatment, or as a supplement to other interventions in patients with nonspecific LBP. Primary outcomes were pain intensity and disability. We assessed risk of bias using the Cochrane Back and Neck (CBN) Review Group 12-item criteria. We combined results in a meta-analysis expressed as mean difference and 95% confidence interval. We assessed the overall quality of the evidence using the GRADE approach. We included 32 trials (n = 2628). Most included trials had a low risk of bias. For acute LBP, low to moderate quality evidence indicates no clinically important differences between MCE and spinal manipulative therapy or other forms of exercise. There is very low-quality evidence that the addition of MCE to medical management does not provide clinically important improvements. For recurrence at one year, there is very low-quality evidence that MCE and medical management decrease the risk of recurrence. For chronic LBP, there is low to moderate quality evidence that MCE is effective for reducing pain compared with minimal intervention. There is low to high-quality evidence that MCE is not clinically more effective than other exercises or manual therapy. There is very low to low quality evidence that MCE is clinically more effective than exercise and electrophysical agents (EPAs) or telerehabilitation for pain and disability. MCE is probably more effective than a minimal intervention for reducing pain, but probably does not have an important effect on disability, in patients with chronic LBP. There was no clinically important difference between MCE and other forms of exercises or manual therapy for acute and chronic LBP. 1.

Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

PubMed Central

Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

2013-01-01

Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414

Artificial intelligence in medicine.

PubMed Central

Ramesh, A. N.; Kambhampati, C.; Monson, J. R. T.; Drew, P. J.

2004-01-01

INTRODUCTION: Artificial intelligence is a branch of computer science capable of analysing complex medical data. Their potential to exploit meaningful relationship with in a data set can be used in the diagnosis, treatment and predicting outcome in many clinical scenarios. METHODS: Medline and internet searches were carried out using the keywords 'artificial intelligence' and 'neural networks (computer)'. Further references were obtained by cross-referencing from key articles. An overview of different artificial intelligent techniques is presented in this paper along with the review of important clinical applications. RESULTS: The proficiency of artificial intelligent techniques has been explored in almost every field of medicine. Artificial neural network was the most commonly used analytical tool whilst other artificial intelligent techniques such as fuzzy expert systems, evolutionary computation and hybrid intelligent systems have all been used in different clinical settings. DISCUSSION: Artificial intelligence techniques have the potential to be applied in almost every field of medicine. There is need for further clinical trials which are appropriately designed before these emergent techniques find application in the real clinical setting. PMID:15333167

Biologically distinct subsets of nevi

PubMed Central

ROGERS, Tova; MARINO, Maria L.; RACITI, Patricia; JAIN, Manu; BUSAM, Klaus J.; MARCHETTI, Michael A.; MARGHOOB, Ashfaq A.

2017-01-01

Melanocytic nevi (MN) encompass a range of benign tumors with varying microscopic and macroscopic features. Their development is a multifactorial process under genetic and environmental influences. The clinical importance of MN lies in distinguishing them from melanoma and in recognizing their associations with melanoma risk and cancer syndromes. Historically, the distinction between the different types of MN, as well as between MN and melanoma, was based on clinical history, gross morphology, and histopathological features. While histopathology with clinical correlation remains the gold standard for differentiating and diagnosing melanocytic lesions, in some cases, this may not be possible. The use of dermoscopy has allowed for the assessment of subsurface skin structures and has contributed to the clinical evaluation and classification of MN. Genetic profiling, while still in its early stages, has the greatest potential to refine the classification of MN by clarifying their developmental processes, biological behaviors, and relationships to melanoma. Here we review the most salient clinical, dermoscopic, histopathological, and genetic features of different MN subgroups. PMID:27119653

Artificial intelligence in medicine.

PubMed

Ramesh, A N; Kambhampati, C; Monson, J R T; Drew, P J

2004-09-01

Artificial intelligence is a branch of computer science capable of analysing complex medical data. Their potential to exploit meaningful relationship with in a data set can be used in the diagnosis, treatment and predicting outcome in many clinical scenarios. Medline and internet searches were carried out using the keywords 'artificial intelligence' and 'neural networks (computer)'. Further references were obtained by cross-referencing from key articles. An overview of different artificial intelligent techniques is presented in this paper along with the review of important clinical applications. The proficiency of artificial intelligent techniques has been explored in almost every field of medicine. Artificial neural network was the most commonly used analytical tool whilst other artificial intelligent techniques such as fuzzy expert systems, evolutionary computation and hybrid intelligent systems have all been used in different clinical settings. Artificial intelligence techniques have the potential to be applied in almost every field of medicine. There is need for further clinical trials which are appropriately designed before these emergent techniques find application in the real clinical setting.

Biological mechanisms of normal tissue damage: importance for the design of NTCP models.

PubMed

Trott, Klaus-Rüdiger; Doerr, Wolfgang; Facoetti, Angelica; Hopewell, John; Langendijk, Johannes; van Luijk, Peter; Ottolenghi, Andrea; Smyth, Vere

2012-10-01

The normal tissue complication probability (NTCP) models that are currently being proposed for estimation of risk of harm following radiotherapy are mainly based on simplified empirical models, consisting of dose distribution parameters, possibly combined with clinical or other treatment-related factors. These are fitted to data from retrospective or prospective clinical studies. Although these models sometimes provide useful guidance for clinical practice, their predictive power on individuals seems to be limited. This paper examines the radiobiological mechanisms underlying the most important complications induced by radiotherapy, with the aim of identifying the essential parameters and functional relationships needed for effective predictive NTCP models. The clinical features of the complications are identified and reduced as much as possible into component parts. In a second step, experimental and clinical data are considered in order to identify the gross anatomical structures involved, and which dose distributions lead to these complications. Finally, the pathogenic pathways and cellular and more specific anatomical parameters that have to be considered in this pathway are determined. This analysis is carried out for some of the most critical organs and sites in radiotherapy, i.e. spinal cord, lung, rectum, oropharynx and heart. Signs and symptoms of severe late normal tissue complications present a very variable picture in the different organs at risk. Only in rare instances is the entire organ the critical target which elicits the particular complication. Moreover, the biological mechanisms that are involved in the pathogenesis differ between the different complications, even in the same organ. Different mechanisms are likely to be related to different shapes of dose effect relationships and different relationships between dose per fraction, dose rate, and overall treatment time and effects. There is good reason to conclude that each type of late complication after radiotherapy depends on its own specific mechanism which is triggered by the radiation exposure of particular structures or sub-volumes of (or related to) the respective organ at risk. Hence each complication will need the development of an NTCP model designed to accommodate this structure. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Cytologic diagnosis: expression of probability by clinical pathologists.

PubMed

Christopher, Mary M; Hotz, Christine S

2004-01-01

Clinical pathologists use descriptive terms or modifiers to express the probability or likelihood of a cytologic diagnosis. Words are imprecise in meaning, however, and may be used and interpreted differently by pathologists and clinicians. The goals of this study were to 1) assess the frequency of use of 18 modifiers, 2) determine the probability of a positive diagnosis implied by the modifiers, 3) identify preferred modifiers for different levels of probability, 4) ascertain the importance of factors that affect expression of diagnostic certainty, and 5) evaluate differences based on gender, employment, and experience. We surveyed 202 clinical pathologists who were board-certified by the American College of Veterinary Pathologists (Clinical Pathology). Surveys were distributed in October 2001 and returned by e-mail, fax, or surface mail over a 2-month period. Results were analyzed by parametric and nonparametric tests. Survey response rate was 47.5% (n = 96) and primarily included clinical pathologists at veterinary schools (n = 58) and diagnostic laboratories (n = 31). Eleven of 18 terms were used "often" or "sometimes" by >/= 50% of respondents. Broad variability was found in the probability assigned to each term, especially those with median values of 75 to 90%. Preferred modifiers for 7 numerical probabilities ranging from 0 to 100% included 68 unique terms; however, a set of 10 terms was used by >/= 50% of respondents. Cellularity and quality of the sample, experience of the pathologist, and implications of the diagnosis were the most important factors affecting the expression of probability. Because of wide discrepancy in the implied likelihood of a diagnosis using words, defined terminology and controlled vocabulary may be useful in improving communication and the quality of data in cytology reporting.

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

PubMed

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

2018-06-01

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

Investigator initiated IBD trials in the US: Facts, obstacles and answers

PubMed Central

Herfarth, Hans H; Jackson, Susan; Schliebe, Barbara G.; Martin, Christopher; Ivanova, Anastasia; Anton, Kristen; Sandler, Robert S; Long, Millie D; Isaacs, Kim L; Osterman, Mark T; Sands, Bruce E; Higgins, Peter D; Lewis, James D

2016-01-01

Investigator initiated randomized clinical trials (IITs) are the backbone of academic clinical research. IITs complement the large clinical studies sponsored by industry and address questions, which are usually not the main focus of a commercially directed research but have the purpose to confirm, improve or refute clinically important questions with regard to diagnostic and therapeutic approaches in patient care. The aim of this review is to illustrate the necessary steps to start and complete an IIT in the field of inflammatory bowel diseases (IBD) in the US. The initial milestones for an investigator include structuring a protocol, planning and building of the trial infrastructure, accurately estimating the costs of the trial and gauging the time span for recruitment. Once the trial has begun it is important to keep patient recruitment on target, monitor of the data quality, and document treatment emergent adverse events. This article provides a framework for the different phases of an IIT and outlines potential hurdles, which could hinder a successful execution. PMID:27598744

Clinical Profiles of Children with Disruptive Behaviors Based on the Severity of Their Conduct Problems, Callous-Unemotional Traits and Emotional Difficulties.

PubMed

Andrade, Brendan F; Sorge, Geoff B; Na, Jennifer Jiwon; Wharton-Shukster, Erika

2015-08-01

This study identified clinical profiles of referred children based on the severity of callous-unemotional (CU) traits, emotional difficulties, and conduct problems. Parents of 166 children (132 males) aged 6-12 years referred to a hospital clinic because of disruptive behavior completed measures to assess these key indicators, and person-centered analysis was used to identify profiles. Four distinct profiles were identified that include: (1) Children low in severity on the three domains, (2) Children high in severity on the three domains, (3) Children high in severity in conduct problems and CU traits with minimal emotional difficulties, and (4) Children high in severity in conduct problems and emotional difficulties with minimal CU traits. Profiles differed in degree of aggression and behavioral impairment. Findings show that clinic-referred children with disruptive behaviors can be grouped based on these important indicators into profiles that have important implications for assessment and treatment selection.

Clinical nursing informatics. Developing tools for knowledge workers.

PubMed

Ozbolt, J G; Graves, J R

1993-06-01

Current research in clinical nursing informatics is proceeding along three important dimensions: (1) identifying and defining nursing's language and structuring its data; (2) understanding clinical judgment and how computer-based systems can facilitate and not replace it; and (3) discovering how well-designed systems can transform nursing practice. A number of efforts are underway to find and use language that accurately represents nursing and that can be incorporated into computer-based information systems. These efforts add to understanding nursing problems, interventions, and outcomes, and provide the elements for databases from which nursing's costs and effectiveness can be studied. Research on clinical judgment focuses on how nurses (perhaps with different levels of expertise) assess patient needs, set goals, and plan and deliver care, as well as how computer-based systems can be developed to aid these cognitive processes. Finally, investigators are studying not only how computers can help nurses with the mechanics and logistics of processing information but also and more importantly how access to informatics tools changes nursing care.

Cardiac Cachexia: Perspectives for Prevention and Treatment.

PubMed

Okoshi, Marina Politi; Capalbo, Rafael Verardino; Romeiro, Fernando G; Okoshi, Katashi

2017-01-01

Cachexia is a prevalent pathological condition associated with chronic heart failure. Its occurrence predicts increased morbidity and mortality independent of important clinical variables such as age, ventricular function, or heart failure functional class. The clinical consequences of cachexia are dependent on both weight loss and systemic inflammation, which accompany cachexia development. Skeletal muscle wasting is an important component of cachexia; it often precedes cachexia development and predicts poor outcome in heart failure. Cachexia clinically affects several organs and systems. It is a multifactorial condition where underlying pathophysiological mechanisms are not completely understood making it difficult to develop specific prevention and treatment therapies. Preventive strategies have largely focused on muscle mass preservation. Different treatment options have been described, mostly in small clinical studies or experimental settings. These include nutritional support, neurohormonal blockade, reducing intestinal bacterial translocation, anemia and iron deficiency treatment, appetite stimulants, immunomodulatory agents, anabolic hormones, and physical exercise regimens. Currently, nonpharmacological therapy such as nutritional support and physical exercise are considered central to cachexia prevention and treatment.

Current State of Information Technologies for the Clinical Research Enterprise across Academic Medical Centers

PubMed Central

Murphy, Shawn N.; Dubey, Anil; Embi, Peter J.; Harris, Paul A.; Richter, Brent G.; Turisco, Fran; Weber, Griffin M.; Tcheng, James E.; Keogh, Diane

2012-01-01

Abstract Information technology (IT) to support clinical research has steadily grown over the past 10 years. Many new applications at the enterprise level are available to assist with the numerous tasks necessary in performing clinical research. However, it is not clear how rapidly this technology is being adopted or whether it is making an impact upon how clinical research is being performed. The Clinical Research Forum’s IT Roundtable performed a survey of 17 representative academic medical centers (AMCs) to understand the adoption rate and implementation strategies within this field. The results were compared with similar surveys from 4 and 6 years ago. We found the adoption rate for four prominent areas of IT‐supported clinical research had increased remarkably, specifically regulatory compliance, electronic data capture for clinical trials, data repositories for secondary use of clinical data, and infrastructure for supporting collaboration. Adoption of other areas of clinical research IT was more irregular with wider differences between AMCs. These differences appeared to be partially due to a set of openly available applications that have emerged to occupy an important place in the landscape of clinical research enterprise‐level support at AMC’s. Clin Trans Sci 2012; Volume #: 1–4 PMID:22686207

[Influence of Aging on Severity and Anti-Inflammatory Treatment of Experimental Dry Eye Disease].

PubMed

Steven, Philipp; Braun, Tobias; Krösser, Sonja; Gehlsen, Uta

2017-05-01

Purpose Aging is an important factor in dry-eye disease that has not been studied in the context of therapeutic measures. Aging-associated modifications of the ocular immune system implicate that anti-inflammatory therapies may act differently among younger individuals in terms of onset and effect of different substances. The goal of this study was to determine differences in clinical phenotype and topical anti-inflammatory therapy using a desiccating stress mouse model. Methods An experimental dry-eye disease (desiccating stress model) was induced in 12-week and 12-month-old female BALB/c mice. Topical therapy included 0.05% cyclosporine/F4H5 (Novaliq), F4H5, 0.05% cyclosporine (Restasis ® , Allergan) and dexamethasone (Monodex ® , Thea Pharma) for 3 consecutive weeks. A control group received no therapy whatsoever. Readout parameters included tear secretion, corneal fluorescein staining at 5 timepoints and histological analysis of goblet cell count at the end of the experiments. Results The older mice demonstrated a significantly stronger dry eye phenotype than the younger mice. Following therapy, the older mice responded to topical anti-inflammatory therapy significantly later than the younger individuals. Regarding the different substances used, cyclosporine/F4H5 showed a significantly faster decrease in corneal fluoresceine staining after only 1 week of therapy in comparison to all other groups. This substance was also superior regarding tear secretion and goblet cell count in age matched groups and in comparison to younger mice. Conclusions These experimental data support the implication that aging should be considered as an important factor in daily clinical practice. Furthermore, the differences found between substance classes, such as calcineurin antagonists and steroids, as well as different drug formulations, should be considered in future pre-clinical and clinical trials. Georg Thieme Verlag KG Stuttgart · New York.

An evaluation of the role of the clinical education facilitator.

PubMed

McCormack, Brendan; Slater, Paul

2006-02-01

The objective of the study was to identify whether clinical education facilitators made a difference to the learning experiences of nurses in a large teaching hospital. Strategies for enabling continuous professional development are well established in health care organizations as key components of approaches to lifelong learning. The benefits of continuous professional development include the maintenance of high standards of care, the improvement and development of services, ensuring the competency of all nursing staff and guaranteeing the accountability of nurses for their actions. The role of clinical education facilitator is relatively new and little evaluation of this role has been undertaken. This study highlights important issues to be considered in developing a 'learning culture' in a hospital organization, through the adoption of such roles as clinical education facilitators. Whilst the roles have had an important function in the active coordination of learning activities in the hospital, there is little evidence of the role directly impacting on the learning culture of clinical settings. Learning mechanisms have been identified. The results of this evaluation can be subjected to further testing through ongoing evaluation of the outcomes arising from the learning mechanisms in place. Given the emphasis on work-based learning and continuing professional development in health care, then this ongoing evaluation can yield important information about future directions for nurse education. The study highlights the importance of supported learning in the workplace. However, more importantly, it identifies the need for a culture of professional practice to be developed in order to sustain learning in practice. Classroom-based learning alone, cannot create a culture of development in nursing and there is thus a need for models of work-based learning to be integrated into practice environments.

The comparative importance of books: clinical psychology in the health sciences library.

PubMed Central

Wehmeyer, J M; Wehmeyer, S

1999-01-01

Clinical psychology has received little attention as a subject in health sciences library collections. This study seeks to demonstrate the relative importance of the monographic literature to clinical psychology through the examination of citations in graduate student theses and dissertations at the Fordham Health Sciences Library, Wright State University. Dissertations and theses were sampled randomly; citations were classified by format, counted, and subjected to statistical analysis. Books and book chapters together account for 35% of the citations in clinical psychology dissertations, 25% in nursing theses, and 8% in biomedical sciences theses and dissertations. Analysis of variance indicates that the citations in dissertations and theses in the three areas differ significantly (F = 162.2 with 2 and 253 degrees of freedom, P = 0.0001). Dissertations and theses in biomedical sciences and nursing theses both cite significantly more journals per book than the dissertations in clinical psychology. These results support the hypothesis that users of clinical psychology literature rely more heavily on books than many other users of a health sciences library. Problems with using citation analyses in a single subject to determine a serials to monographs ratio for a health sciences library are pointed out. PMID:10219478

Raising Public Awareness of Clinical Trials: Development of Messages for a National Health Communication Campaign.

PubMed

Massett, Holly A; Dilts, David M; Bailey, Robert; Berktold, Jennifer; Ledsky, Rebecca; Atkinson, Nancy L; Mishkin, Grace; Denicoff, Andrea; Padberg, Rose Mary; Allen, Marin P; Silver, Karen; Carrington, Kelli; Johnson, Lenora E

2017-05-01

Clinical trials are essential for developing new and effective treatments and improving patient quality of life; however, many trials cannot answer their primary research questions because they fall short of their recruitment goals. This article reports the results of formative research conducted in two populations, the public and primary care physicians, to identify messages that may raise awareness and increase interest in clinical trials and be used in a national communication campaign. Results suggested that participants were primarily motivated to participate in clinical trials out of a self-interest to help themselves first. Messages illustrated that current treatments were tested via clinical trials, helped normalize trials as routine practices, and reduced concerns over trying something new first. Participants wanted messages that portray trials as state-of-the-art choices that offer some hope, show people like themselves, and are described in a clear, concise manner with actionable steps for them to take. The study revealed some differences in message salience, with healthy audiences exhibiting lower levels of interest. Our results suggest that targeted messages are needed, and that communication with primary health-care providers is an important and necessary component in raising patient awareness of the importance of clinical trials.

[Differences between plaque-like variants of dermatofibrosarcoma protuberans and plaque-like dermal fibromatosis (dermatomyofibroma)].

PubMed

Hügel, H; Kutzner, H; Rütten, A; Biess, B

1994-05-01

On the basis of two cases the differences between the plaque-like variant of dermatofibrosarcoma protuberans (PDFSP) and the plaque-like dermal fibromatosis (synonym: dermatomyofibroma; PDF) are presented. PDFSP and PDF are two clinically very similar dermal fibrous proliferations, but differentiation is important because of their different therapy and prognosis. Histologically and immunohistochemically PDFSP and PDF can be recognized as separate entities.

Quality of Life After Cardiac Surgery Based on the Minimal Clinically Important Difference Concept.

PubMed

Grand, Nathalie; Bouchet, Jean Baptiste; Zufferey, Paul; Beraud, Anne Marie; Awad, Sahar; Sandri, Fabricio; Campisi, Salvator; Fuzellier, Jean François; Molliex, Serge; Vola, Marco; Morel, Jerome

2018-03-23

Health-related quality of life (HRQOL) is an increasingly important issue in assessing the consequences of any surgical or medical intervention. Our study aimed to evaluate change in HRQOL 6 months after elective cardiac surgery and to identify specific predictors of poor HRQOL. In this prospective, single-center study, HRQOL was evaluated before and 6 months after surgery using the SF-36 questionnaire and its two components: the physical component summary (PCS) and the mental component summary (MCS). We distinguished patients with worsening of HRQOL according to the minimal clinically important difference. All consecutive adult patients undergoing cardiac surgery were included. 326 patients completed the preoperative and postoperative SF-36 questionnaires and 24 patients died before completing follow-up questionnaires. Based on the definition used, clinically significant deterioration of HRQOL was observed in 93 patients (26.6%) for PCS and 99 patients (28.2%) for MCS. Renal replacement for acute renal failure and mechanical ventilation for longer than 48 hours were independent risk factors for PCS and MCS worsening or death. Although our study showed overall improvement of QOL after cardiac surgery, over a quarter of the patients manifested deterioration of HRQOL at 6 months post-surgery. The findings from this study should help clinicians to inform patients about their likely postoperative functional status and quality of life. Copyright © 2018. Published by Elsevier Inc.

Monitoring somatic symptoms in patients with mental disorders: Sensitivity to change and minimal clinically important difference of the Somatic Symptom Scale - 8 (SSS-8).

PubMed

Gierk, Benjamin; Kohlmann, Sebastian; Hagemann-Goebel, Marion; Löwe, Bernd; Nestoriuc, Yvonne

2017-09-01

The SSS-8 is a brief questionnaire for the assessment of somatic symptom burden. This study examines its sensitivity to change and the minimal clinically important difference (MCID) in patients with mental disorders. 55 outpatients with mental disorders completed the SSS-8 and measures of anxiety, depression, and disability before and after receiving treatment. Effect sizes and correlations between the change scores were calculated. The MCID was estimated using a one standard error of measurement threshold and the change in disability as an external criterion. There was a medium decline in somatic symptom burden for the complete sample (n=55, d z =0.53) and a large decline in a subgroup with very high somatic symptom burden at baseline (n=11, d z =0.94). Decreases in somatic symptom burden were associated with decreases in anxiety (r=0.68, p<0.001), depression (r=0.62, p<0.001) and disability (r=0.51, p<0.001). The MCID was estimated as a 3-point decrease. The SSS-8 is sensitive to change. A 3-point decrease reflects a clinically important improvement. Due to its brevity and sound psychometric properties, the SSS-8 is useful for monitoring somatic symptom burden. Copyright © 2017 Elsevier Inc. All rights reserved.

Minimal clinically important difference of voice handicap index-10 in vocal fold paralysis.

PubMed

Young, VyVy N; Jeong, Kwonho; Rothenberger, Scott D; Gillespie, Amanda I; Smith, Libby J; Gartner-Schmidt, Jackie L; Rosen, Clark A

2018-06-01

The Voice Handicap Index-10 (VHI-10) is commonly used to measure patients' perception of vocal handicap. Clinical consensus has previously defined clinically meaningful improvement as a decrease ≥5. This study determines the minimal clinically important difference (MCID) for VHI-10 in patients with unilateral vocal fold paralysis (UVFP) using anchor-based methodology. Prospective cohort questionnaire analysis. Two hundred eighty-one UVFP patients completed the VHI-10 on two consecutive visits (within 3 months). At the follow-up visit, patients answered an 11-point Global Rating of Change Questionnaire (GRCQ) scored from -5 to +5. Relationship between the GRCQ and change in VHI-10 was quantified using analysis of variance, and MCID for the VHI-10 was determined using receiver operating characteristic (ROC) curve analysis. Overall mean VHI-10 change was -3.71 (standard deviation [SD] = 8.89) and mean GRCQ was 1.37 (SD = 2.51). Average interval between measurements was 1.73 months (SD = 0.83). Mean changes in VHI-10 scores were -7.45, -0.53, and +4.40 for patients whose GRCQ scores indicated improvement, no change, and worsening, respectively. Differences between mean scores were statistically significant (P < .001). Area under the ROC curve was 0.80, demonstrating the classification accuracy of VHI-10 change scores. A VHI-10 change of -4 was determined to be the optimal threshold that discriminated between improvement and no improvement (sensitivity and specificity 0.62 and 0.88, respectively). The MCID for improvement in VHI-10 in UVFP patients is a decrease of 4. This information improves understanding of patients' response to treatment and allows comparison between different treatments. Future research should determine MCID for VHI-10 across all voice disorders. 4. Laryngoscope, 128:1419-1424, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

RELATIONSHIP BETWEEN ISOMETRIC THIGH MUSCLE STRENGTH AND MINIMAL CLINICALLY IMPORTANT DIFFERENCES (MCIDS) IN KNEE FUNCTION IN OSTEOARTHRITIS – DATA FROM THE OSTEOARTHRITIS INITIATIVE

PubMed Central

Ruhdorfer, Anja; Wirth, Wolfgang; Eckstein, Felix

2014-01-01

Objective To determine the relationship between thigh muscle strength and clinically relevant differences in self-assessed lower limb function. Methods Isometric knee extensor and flexor strength of 4553 Osteoarthritis Initiative participants (2651 women/1902 men) was related to Western Ontario McMasters Universities (WOMAC) physical function scores by linear regression. Further, groups of Male and female participant strata with minimal clinically important differences (MCIDs) in WOMAC function scores (6/68) were compared across the full range of observed values, and to participants without functional deficits (WOMAC=0). The effect of WOMAC knee pain and body mass index on the above relationships was explored using stepwise regression. Results Per regression equations, a 3.7% reduction in extensor and a 4.0% reduction in flexor strength were associated with an MCID in WOMAC function in women, and a 3.6%/4.8% reduction in men. For strength divided by body weight, reductions were 5.2%/6.7% in women and 5.8%/6.7% in men. Comparing MCID strata across the full observed range of WOMAC function confirmed the above estimates and did not suggest non-linear relationships across the spectrum of observed values. WOMAC pain correlated strongly with WOMAC function, but extensor (and flexor) muscle strength contributed significant independent information. Conclusion Reductions of approximately 4% in isometric muscle strength and of 6% in strength/weight were related to a clinically relevant difference in WOMAC functional disability. Longitudinal studies will need to confirm these relationships within persons. Muscle extensor (and flexor) strength (per body weight) provided significant independent information in addition to pain in explaining variability in lower limb function. PMID:25303012

Measurement Properties of the Lower Extremity Functional Scale: A Systematic Review.

PubMed

Mehta, Saurabh P; Fulton, Allison; Quach, Cedric; Thistle, Megan; Toledo, Cesar; Evans, Neil A

2016-03-01

Systematic review of measurement properties. Many primary studies have examined the measurement properties, such as reliability, validity, and sensitivity to change, of the Lower Extremity Functional Scale (LEFS) in different clinical populations. A systematic review summarizing these properties for the LEFS may provide an important resource. To locate and synthesize evidence on the measurement properties of the LEFS and to discuss the clinical implications of the evidence. A literature search was conducted in 4 databases (PubMed, MEDLINE, Embase, and CINAHL), using predefined search terms. Two reviewers performed a critical appraisal of the included studies using a standardized assessment form. A total of 27 studies were included in the review, of which 18 achieved a very good to excellent methodological quality level. The LEFS scores demonstrated excellent test-retest reliability (intraclass correlation coefficients ranging between 0.85 and 0.99) and demonstrated the expected relationships with measures assessing similar constructs (Pearson correlation coefficient values of greater than 0.7). The responsiveness of the LEFS scores was excellent, as suggested by consistently high effect sizes (greater than 0.8) in patients with different lower extremity conditions. Minimal detectable change at the 90% confidence level (MDC90) for the LEFS scores varied between 8.1 and 15.3 across different reassessment intervals in a wide range of patient populations. The pooled estimate of the MDC90 was 6 points and the minimal clinically important difference was 9 points in patients with lower extremity musculoskeletal conditions, which are indicative of true change and clinically meaningful change, respectively. The results of this review support the reliability, validity, and responsiveness of the LEFS scores for assessing functional impairment in a wide array of patient groups with lower extremity musculoskeletal conditions.

Clinical documentation variations and NLP system portability: a case study in asthma birth cohorts across institutions.

PubMed

Sohn, Sunghwan; Wang, Yanshan; Wi, Chung-Il; Krusemark, Elizabeth A; Ryu, Euijung; Ali, Mir H; Juhn, Young J; Liu, Hongfang

2017-11-30

To assess clinical documentation variations across health care institutions using different electronic medical record systems and investigate how they affect natural language processing (NLP) system portability. Birth cohorts from Mayo Clinic and Sanford Children's Hospital (SCH) were used in this study (n = 298 for each). Documentation variations regarding asthma between the 2 cohorts were examined in various aspects: (1) overall corpus at the word level (ie, lexical variation), (2) topics and asthma-related concepts (ie, semantic variation), and (3) clinical note types (ie, process variation). We compared those statistics and explored NLP system portability for asthma ascertainment in 2 stages: prototype and refinement. There exist notable lexical variations (word-level similarity = 0.669) and process variations (differences in major note types containing asthma-related concepts). However, semantic-level corpora were relatively homogeneous (topic similarity = 0.944, asthma-related concept similarity = 0.971). The NLP system for asthma ascertainment had an F-score of 0.937 at Mayo, and produced 0.813 (prototype) and 0.908 (refinement) when applied at SCH. The criteria for asthma ascertainment are largely dependent on asthma-related concepts. Therefore, we believe that semantic similarity is important to estimate NLP system portability. As the Mayo Clinic and SCH corpora were relatively homogeneous at a semantic level, the NLP system, developed at Mayo Clinic, was imported to SCH successfully with proper adjustments to deal with the intrinsic corpus heterogeneity. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

PubMed

Bates, Katherine E; Vetter, Victoria L; Li, Jennifer S; Cummins, Susan; Aguel, Fernando; Almond, Christopher; Dubin, Anne M; Elia, Josephine; Finkle, John; Hausner, Elizabeth A; Joseph, Francesca; Karkowsky, Abraham M; Killeen, Matthew; Lemacks, Jodi; Mathis, Lisa; McMahon, Ann W; Pinnow, Ellen; Rodriguez, Ignacio; Stockbridge, Norman L; Stockwell, Margaret; Tassinari, Melissa; Krucoff, Mitchell W

2012-10-01

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank convened on December 10, 2010, where members from academia, industry, and regulatory agencies discussed important issues regarding pediatric cardiovascular safety of medications and cardiovascular devices. Pediatric drug and device development may use adult data but often requires additional preclinical and clinical testing to characterize effects on cardiac function and development. Challenges in preclinical trials include identifying appropriate animal models, clinically relevant efficacy end points, and methods to monitor cardiovascular safety. Pediatric clinical trials have different ethical concerns from adult trials, including consideration of the subjects' families. Clinical trial design in pediatrics should assess risks and benefits as well as incorporate input from families. Postmarketing surveillance, mandated by federal law, plays an important role in both drug and device safety assessment and becomes crucial in the pediatric population because of the limitations of premarketing pediatric studies. Solutions for this wide array of issues will require collaboration between academia, industry, and government as well as creativity in pediatric study design. Formation of various epidemiologic tools including registries to describe outcomes of pediatric cardiac disease and its treatment as well as cardiac effects of noncardiovascular medications, should inform preclinical and clinical development and improve benefit-risk assessments for the patients. The discussions in this article summarize areas of emerging consensus and other areas in which consensus remains elusive and provide suggestions for additional research to further our knowledge and understanding of this topic. Copyright © 2012 Mosby, Inc. All rights reserved.

Fluoroquinolone resistance in clinical and environmental isolates of Escherichia coli in Mexico City.

PubMed

Amábile-Cuevas, C F; Arredondo-García, J L; Cruz, A; Rosas, Irma

2010-01-01

To assess the different phenotypes and mechanisms of fluoroquinolone (FQ) resistance in clinical and environmental isolates of Escherichia coli. We compared FQ-resistant E. coli isolates, measuring minimal inhibitory concentrations (MIC) of ciprofloxacin, along with susceptibility to other antibiotics. We also searched for the presence of efflux pumps, using efflux inhibitors, and for plasmid-borne FQ-resistance by PCR. We found that, aside from the higher FQ-resistance prevalence among clinical strains, environmental ones resist much lower concentrations of ciprofloxacin. Efflux pumps mediate fluoroquinolone resistance as frequently among environmental isolates than in clinical strains. Plasmid-borne qnrA genes were not detected in any resistant strain. Environmental FQ-resistant strains may have a nonclinical origin and/or a selective pressure different from the clinical use of FQs. The identification of the source of low-level FQ-resistant strains (ciprofloxacin MIC c. 8 microg ml(-1)) in the environment could be important to curb the rapid emergence and spread of FQ-resistance in clinical settings, as these strains can easily become fully resistant to FQ concentrations achievable in fluids and tissues during therapy.

Brief communication: use of the minimal important difference for a meta-analysis on exercise and anxiety in adults with arthritis.

PubMed

Kelley, George A; Kelley, Kristi S; Callahan, Leigh F

2018-07-01

A recent meta-analysis reported statistically significant improvements in anxiety as a result of exercise in adults with arthritis and other rheumatic diseases (AORD) using the traditional standardized mean difference (SMD) effect size (ES). The objective of this study was to use the more recently developed and clinically relevant minimal important difference (MID) approach to examine this association. Data from a previous meta-analysis of 14 randomized controlled trials representing 926 initially enrolled adults ≥ 18 years of age (539 exercise, 387 control) was used to calculate the ES using the MID approach. Minimal important difference data were derived from previously reported anchor-based values that represented the different instruments used to assess anxiety. Effect sizes were pooled using the inverse heterogeneity (IVhet) model. Overall, exercise resulted in a mean ES reduction in anxiety of - 0.80 (95% CI, - 1.60 to 0.001, p = 0.05; Q = 92.1, p < 0.001, I 2  = 83.7%, 95% CI, 74.9%, 89.5%), suggesting that overall, exercise may benefit an appreciable number of patients. Nonetheless, this effect spanned the range from many patients gaining important benefits to no patients improving. The clinically relevant effects of exercise on anxiety in adults with AORD are varied. However, these results should be interpreted with caution given the absence of anchor-based MID data specific to the instruments and questions used to assess anxiety in adults with AORD. A need exists for future research to establish instrument-specific, anchor-based MID values for questions assessing anxiety in adults with AORD.

Non-invasive Brain Stimulation in the Treatment of Post-stroke and Neurodegenerative Aphasia: Parallels, Differences, and Lessons Learned

PubMed Central

Norise, Catherine; Hamilton, Roy H.

2017-01-01

Numerous studies over the span of more than a decade have shown that non-invasive brain stimulation (NIBS) techniques, namely transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), can facilitate language recovery for patients who have suffered from aphasia due to stroke. While stroke is the most common etiology of aphasia, neurodegenerative causes of language impairment—collectively termed primary progressive aphasia (PPA)—are increasingly being recognized as important clinical phenotypes in dementia. Very limited data now suggest that (NIBS) may have some benefit in treating PPAs. However, before applying the same approaches to patients with PPA as have previously been pursued in patients with post-stroke aphasia, it will be important for investigators to consider key similarities and differences between these aphasia etiologies that is likely to inform successful approaches to stimulation. While both post-stroke aphasia and the PPAs have clear overlaps in their clinical phenomenology, the mechanisms of injury and theorized neuroplastic changes associated with the two etiologies are notably different. Importantly, theories of plasticity in post-stroke aphasia are largely predicated on the notion that regions of the brain that had previously been uninvolved in language processing may take on new compensatory roles. PPAs, however, are characterized by slow distributed degeneration of cellular units within the language system; compensatory recruitment of brain regions to subserve language is not currently understood to be an important aspect of the condition. This review will survey differences in the mechanisms of language representation between the two etiologies of aphasia and evaluate properties that may define and limit the success of different neuromodulation approaches for these two disorders. PMID:28167904

Does ASA classification impact success rates of endovascular aneurysm repairs?

PubMed

Conners, Michael S; Tonnessen, Britt H; Sternbergh, W Charles; Carter, Glen; Yoselevitz, Moises; Money, Samuel R

2002-09-01

The purpose of this study was to evaluate the technical success, clinical success, postoperative complication rate, need for a secondary procedure, and mortality rate with endovascular aneurysm repair (EAR), based on the physical status classification scheme advocated by the American Society of Anesthesiologists (ASA). At a single institution 167 patients underwent attempted EAR. Query of a prospectively maintained database supplemented with a retrospective review of medical records was used to gather statistics pertaining to patient demographics and outcome. In patients selected for EAR on the basis of acceptable anatomy, technical and clinical success rates were not significantly different among the different ASA classifications. Importantly, postoperative complication and 30-day mortality rates do not appear to significantly differ among the different ASA classifications in this patient population.

Venous malformations of the head and neck: a diagnostic approach and a proposed management approach based on clinical, radiological, and histopathology findings.

PubMed

Aboelatta, Yasser Abdallah; Nagy, Eman; Shaker, Mohamed; Massoud, Karim Samir

2014-07-01

There is no easy road map for venous malformations (VMs) of the head and neck according to which treatment modality can be chosen. The purpose of this study was to identify different types of VMs of the head and neck based on clinical, histopathology, MRI, and venography findings that help in specification of different treatment modalities. Sixty-nine patients with VMs of the head and neck were included in this study. Our results proposed a diagnostic approach for VMs of the head and neck. MRI, venography, and clinical examination had important impact in decision-making, whereas histopathology had no impact. A management approach has been suggested for each type and its subtypes. Copyright © 2013 Wiley Periodicals, Inc.

[Infectious mononucleosis: etiology, immunological variants, methods of correction].

PubMed

Gordeets, A V; Savina, O G; Beniova, S N; Chernikova, A A

2011-01-01

Clinical options of infectious mononucleosis course depending on infecting agent etiology are presented for Epstein-Barr virus (EBV), cytomegalovirus (CMV), mono and mixed forms of the disease. Examined cytokine profiles demonstrate analogous changes of serum cytokines in the acute stage of the disease irrespective of etiological factors. Data show that it is important and useful clinically and immunologically to include immunomodulators--in particular, cycloferon--info a complex therapy of different types of mononucleosis.

Clinical trials of GMP products in the gene therapy field.

PubMed

Bamford, Kathleen B

2011-01-01

Advances in gene therapy are increasingly leading to clinical assessment in many fields of medicine with diverse approaches. The basic science stems from approaches aimed at different functions such as correcting a missing/abnormal gene, altering the proportion or expression of normal genes to augment a physiological process or using this principle to destroy malignant or infected cells. As the technology advances, it is increasingly important to ensure that clinical trials answer the questions that need to be asked. In this chapter we review examples of published clinical trials, resources for accessing information about registered trials, the process of regulating trials, good clinical practice, and good manufacturing practice as well as summarising the approach taken by regulatory authorities in reviewing applications for the introduction of products for use in the clinic.

Advancing Evidence-Based Practice in Physical Therapy Settings: Multinational Perspectives on Implementation Strategies and Interventions.

PubMed

Bernhardsson, Susanne; Lynch, Elizabeth; Dizon, Janine Margarita; Fernandes, Jasmin; Gonzalez-Suarez, Consuelo; Lizarondo, Lucylynn; Luker, Julie; Wiles, Louise; Grimmer, Karen

2017-01-01

It is of critical importance that findings from the wealth of clinical physical therapist research are transferred into clinical practice without unnecessary delays. There is a lack of knowledge about strategies that can be used to effectively implement physical therapist research findings and evidence-based practice (EBP) into everyday clinical practice in different national settings and contexts. The purpose of this article is to contribute to knowledge about effective strategies for implementing EBP that have been studied in different national physical therapy settings. The specific aims of this article are to share experiences and provide a current multinational perspective on different approaches and strategies for implementing EBP and to highlight important considerations and implications for both research and practice. Six research studies from various settings in 3 countries are described and synthesized. Key characteristics of the studies and intervention components are tabulated and mapped to the Cochrane Effective Practice and Organisation of Care taxonomy. Commonalities and differences are presented. The implementation strategies described were: a theory-based guideline implementation tailored to identified barriers and facilitators; a multifaceted EBP training package; journal clubs; a multifaceted strategy comprising contextualized procedures, protocols, and standardized resources; barrier identification, education, audit, feedback, and reminders; and contextualized guidelines. Commonalities were the use of a multifaceted approach, educational measures, and clinical guidelines. Key outcomes across the studies were improved attitudes and increased awareness, knowledge, skills, and confidence in EBP; better access to clinical practice guidelines and other EBP resources; identification of barriers that could be targeted in future implementation activities; earlier referrals; and use of recommended outcome measures. The article can serve as a template for other physical therapist researchers in designing implementation studies, as well as to inform policies and practice for health care managers and decision makers who are looking for ways to implement research findings in their organizations. © 2017 American Physical Therapy Association.

Epidermal growth factor receptor expression in different subtypes of oral lichenoid disease

PubMed Central

Cortés-Ramírez, Dionisio A.; Rodríguez-Tojo, María J.; Coca-Meneses, Juan C.; Marichalar-Mendia, Xabier

2014-01-01

The oral lichenoid disease (OLD) includes different chronic inflammatory processes such as oral lichen planus (OLP) and oral lichenoid lesions (OLL), both entities with controversial diagnosis and malignant potential. Epidermal growth factor receptor (EFGR) is an important oral carcinogenesis biomarker and overexpressed in several oral potentially malignant disorders. Objectives: To analyze the EGFR expression in the OLD to find differences between OLP and OLL, and to correlate it with the main clinical and pathological features. Material and Methods: Forty-four OLD cases were studied and classified according to their clinical (Group C1: only papular lesions / Group C2: papular and other lesions) and histopathological features (Group HT: OLP-typical / Group HC: OLP-compatible) based in previous published criteria. Standard immunohistochemical identification of EGFR protein was performed. Comparative and descriptive statistical analyses were performed. Results: Thirty-five cases (79.5%) showed EGFR overexpression without significant differences between clinical and histopathological groups (p<0.05). Histological groups showed significant differences in the EGFR expression pattern (p=0.016). Conlusions: All OLD samples showed high EGFR expression. The type of clinical lesion was not related with EGFR expression; however, there are differences in the EGFR expression pattern between histological groups that may be related with a different biological profile and malignant risk. Key words:Oral lichenoid disease, oral lichen planus, oral lichenoid lesion, oral carcinogenesis, EGFR. PMID:24880441

Basics of Compounding: Clinical Pharmaceutics, Part 2.

PubMed

Allen, Loyd V

2016-01-01

This article represents part 2 of a 2-part article on the topic of clinical pharmaceutics. Pharmaceutics is relevant far beyond the pharmaceutical industry, compounding, and the laboratory. Pharmaceutics can be used to solve many clinical problems in medication therapy. A pharmacists' knowledge of the physicochemical aspects of drugs and drug products should help the patient, physician, and healthcare professionals resolve issues in the increasingly complex world of modern medicine. Part 1 of this series of articles discussed incompatibilities which can directly affect a clinical outcome and utilized pharmaceutics case examples of the application and importance of clinical pharmaceutics covering different characteristics. Part 2 continues to illustrate the scientific principles and clinical effects involved in clinical pharmaceutics. Also covered in this article are many of the scientific principles in typical to patient care. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Multicenter Study of Antimicrobial Susceptibility of Anaerobic Bacteria in Korea in 2012

PubMed Central

Lee, Yangsoon; Park, Yeon-Joon; Kim, Mi-Na; Uh, Young; Kim, Myung Sook

2015-01-01

Background Periodic monitoring of regional or institutional resistance trends of clinically important anaerobic bacteria is recommended, because the resistance of anaerobic pathogens to antimicrobial drugs and inappropriate therapy are associated with poor clinical outcomes. There has been no multicenter study of clinical anaerobic isolates in Korea. We aimed to determine the antimicrobial resistance patterns of clinically important anaerobes at multiple centers in Korea. Methods A total of 268 non-duplicated clinical isolates of anaerobic bacteria were collected from four large medical centers in Korea in 2012. Antimicrobial susceptibility was tested by the agar dilution method according to the CLSI guidelines. The following antimicrobials were tested: piperacillin, piperacillin-tazobactam, cefoxitin, cefotetan, imipenem, meropenem, clindamycin, moxifloxacin, chloramphenicol, metronidazole, and tigecycline. Results Organisms of the Bacteroides fragilis group were highly susceptible to piperacillin-tazobactam, imipenem, and meropenem, as their resistance rates to these three antimicrobials were lower than 6%. For B. fragilis group isolates and anaerobic gram-positive cocci, the resistance rates to moxifloxacin were 12-25% and 11-13%, respectively. Among B. fragilis group organisms, the resistance rates to tigecycline were 16-17%. Two isolates of Finegoldia magna were non-susceptible to chloramphenicol (minimum inhibitory concentrations of 16-32 mg/L). Resistance patterns were different among the different hospitals. Conclusions Piperacillin-tazobactam, cefoxitin, and carbapemems are highly active β-lactam agents against most of the anaerobes. The resistance rates to moxifloxacin and tigecycline are slightly higher than those in the previous study. PMID:26206683

Methodologic ramifications of paying attention to sex and gender differences in clinical research.

PubMed

Prins, Martin H; Smits, Kim M; Smits, Luc J

2007-01-01

Methodologic standards for studies on sex and gender differences should be developed to improve reporting of studies and facilitate their inclusion in systematic reviews. The essence of these studies lies within the concept of effect modification. This article reviews important methodologic issues in the design and reporting of pharmacogenetic studies. Differences in effect based on sex or gender should preferably be expressed in absolute terms (risk differences) to facilitate clinical decisions on treatment. Information on the distribution of potential effect modifiers or prognostic factors should be available to prevent a biased comparison of differences in effect between genotypes. Other considerations included the possibility of selective nonavailability of biomaterial and the choice of a statistical model to study effect modification. To ensure high study quality, additional methodologic issues should be taken into account when designing and reporting studies on sex and gender differences.

Clinical pharmacy in a multidisciplinar team for chronic pain in adults.

PubMed

Bauters, T G M; Devulder, J; Robays, H

2008-01-01

The aim of this study was to evaluate the role and the impact of a clinical pharmacist as a member of a multidisciplinary pain team. Although physicians have a good knowledge of pharmacotherapy in the field of pain medication, pharmacy interventions were necessary to enhance the quality of prescribing. On a population of 93 patients, a total of 120 interventions were recorded. The different types of interventions included: provision of information (10.0%), clinical intervention (89.2%) and the provision of a specific product (0.8%). Out of the 107 clinical interventions, a total of 95.3 % interventions were accepted by the physicians. The results highlight the clinical importance of the pharmacy in optimizing drug therapy for adult patients with chronic pain.

Gastric tumours in hereditary cancer syndromes: clinical features, molecular biology and strategies for prevention.

PubMed

Sereno, María; Aguayo, Cristina; Guillén Ponce, Carmen; Gómez-Raposo, César; Zambrana, Francisco; Gómez-López, Miriam; Casado, Enrique

2011-09-01

Gastric cancer is the major cause of cancer-related deaths worldwide. The majority of them are classified as sporadic, whereas the remaining 10% exhibit familial clustering. Hereditary diffuse gastric cancer (HDGC) syndrome is the most important condition that leads to hereditary gastric cancer. However, other hereditary cancer syndromes, such as hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, Peutz-Jeghers syndrome, Li-Fraumeni syndrome and hereditary breast and ovarian cancer, entail a higher risk compared to the general population for developing this kind of neoplasia. In this review, we describe briefly the most important aspects related to clinical features, molecular biology and strategies for prevention in hereditary gastric associated to different cancer syndromes.

Talk About Sex: Sexual History-Taking Preferences Among Urogynecology Patients and General Gynecology Controls.

PubMed

Fairchild, Pamela Susan; Haefner, Jessica Katherine; Berger, Mitchell Brian

2016-01-01

The aim of the study was to investigate patients' experiences and preferences regarding sexual history taking. We also sought to compare preferences between women in general gynecology versus urogynecology clinics and between women of different ages. This is a survey of 219 patients presenting in gynecology and 164 in urogynecology clinics. Surveys were voluntary and anonymous. Survey instruments included questions about sexual function, past experiences, and preferences regarding taking a clinical sexual history. Subjects agreed that sexual health is important for overall health and should be asked about regularly. Most respondents were not embarrassed to discuss sexual history. When asked about experience with providers, subjects reported that their primary care providers (PCPs) inquired infrequently about their sexual health. Respondents perceived that obstetrician-gynecologists asked about sexual health more frequently than PCPs. There were no significant differences between general gynecology and urogynecology patients' history-taking preferences. Younger women were more likely to feel that sexual health was an important aspect of overall well-being, whereas older women were more likely to agree that sexual problems are unavoidable with age. On logistic regression, there was an association between the ages of younger than 40 years and expressing agreement that providers should frequently ask patients about sexual health. Agreeing that sexual health is an important part of well-being was also associated with being in the 40 years or younger group. Patients place importance on sexual health history as part of their overall health, and providers should more frequently query their patients about this topic. Both PCPs and obstetrician-gynecologists have room for improvement.

Genome-Wide Identification of Host-Segregating Epidemiological Markers for Source Attribution in Campylobacter jejuni

PubMed Central

Thépault, Amandine; Méric, Guillaume; Rivoal, Katell; Pascoe, Ben; Mageiros, Leonardos; Touzain, Fabrice; Rose, Valérie; Béven, Véronique; Chemaly, Marianne

2017-01-01

ABSTRACT Campylobacter is among the most common worldwide causes of bacterial gastroenteritis. This organism is part of the commensal microbiota of numerous host species, including livestock, and these animals constitute potential sources of human infection. Molecular typing approaches, especially multilocus sequence typing (MLST), have been used to attribute the source of human campylobacteriosis by quantifying the relative abundance of alleles at seven MLST loci among isolates from animal reservoirs and human infection, implicating chicken as a major infection source. The increasing availability of bacterial genomes provides data on allelic variation at loci across the genome, providing the potential to improve the discriminatory power of data for source attribution. Here we present a source attribution approach based on the identification of novel epidemiological markers among a reference pan-genome list of 1,810 genes identified by gene-by-gene comparison of 884 genomes of Campylobacter jejuni isolates from animal reservoirs, the environment, and clinical cases. Fifteen loci involved in metabolic activities, protein modification, signal transduction, and stress response or coding for hypothetical proteins were selected as host-segregating markers and used to attribute the source of 42 French and 281 United Kingdom clinical C. jejuni isolates. Consistent with previous studies of British campylobacteriosis, analyses performed using STRUCTURE software attributed 56.8% of British clinical cases to chicken, emphasizing the importance of this host reservoir as an infection source in the United Kingdom. However, among French clinical isolates, approximately equal proportions of isolates were attributed to chicken and ruminant reservoirs, suggesting possible differences in the relative importance of animal host reservoirs and indicating a benefit for further national-scale attribution modeling to account for differences in production, behavior, and food consumption. IMPORTANCE Accurately quantifying the relative contribution of different host reservoirs to human Campylobacter infection is an ongoing challenge. This study, based on the development of a novel source attribution approach, provides the first results of source attribution in Campylobacter jejuni in France. A systematic analysis using gene-by-gene comparison of 884 genomes of C. jejuni isolates, with a pan-genome list of genes, identified 15 novel epidemiological markers for source attribution. The different proportions of French and United Kingdom clinical isolates attributed to each host reservoir illustrate a potential role for local/national variations in C. jejuni transmission dynamics. PMID:28115376

Use of Wearable Sensors and Biometric Variables in an Artificial Pancreas System.

PubMed

Turksoy, Kamuran; Monforti, Colleen; Park, Minsun; Griffith, Garett; Quinn, Laurie; Cinar, Ali

2017-03-07

An artificial pancreas (AP) computes the optimal insulin dose to be infused through an insulin pump in people with Type 1 Diabetes (T1D) based on information received from a continuous glucose monitoring (CGM) sensor. It has been recognized that exercise is a major challenge in the development of an AP system. The use of biometric physiological variables in an AP system may be beneficial for prevention of exercise-induced challenges and better glucose regulation. The goal of the present study is to find a correlation between biometric variables such as heart rate (HR), heat flux (HF), skin temperature (ST), near-body temperature (NBT), galvanic skin response (GSR), and energy expenditure (EE), 2D acceleration-mean of absolute difference (MAD) and changes in glucose concentrations during exercise via partial least squares (PLS) regression and variable importance in projection (VIP) in order to determine which variables would be most useful to include in a future artificial pancreas. PLS and VIP analyses were performed on data sets that included seven different types of exercises. Data were collected from 26 clinical experiments. Clinical results indicate ST to be the most consistently important (important for six out of seven tested exercises) variable over all different exercises tested. EE and HR are also found to be important variables over several types of exercise. We also found that the importance of GSR and NBT observed in our experiments might be related to stress and the effect of changes in environmental temperature on glucose concentrations. The use of the biometric measurements in an AP system may provide better control of glucose concentration.

Natural language processing systems for capturing and standardizing unstructured clinical information: A systematic review.

PubMed

Kreimeyer, Kory; Foster, Matthew; Pandey, Abhishek; Arya, Nina; Halford, Gwendolyn; Jones, Sandra F; Forshee, Richard; Walderhaug, Mark; Botsis, Taxiarchis

2017-09-01

We followed a systematic approach based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses to identify existing clinical natural language processing (NLP) systems that generate structured information from unstructured free text. Seven literature databases were searched with a query combining the concepts of natural language processing and structured data capture. Two reviewers screened all records for relevance during two screening phases, and information about clinical NLP systems was collected from the final set of papers. A total of 7149 records (after removing duplicates) were retrieved and screened, and 86 were determined to fit the review criteria. These papers contained information about 71 different clinical NLP systems, which were then analyzed. The NLP systems address a wide variety of important clinical and research tasks. Certain tasks are well addressed by the existing systems, while others remain as open challenges that only a small number of systems attempt, such as extraction of temporal information or normalization of concepts to standard terminologies. This review has identified many NLP systems capable of processing clinical free text and generating structured output, and the information collected and evaluated here will be important for prioritizing development of new approaches for clinical NLP. Copyright © 2017 Elsevier Inc. All rights reserved.

Becoming a professional: What is the influence of registered nurses on nursing students' learning in the clinical environment?

PubMed

Ó Lúanaigh, Padraig

2015-11-01

This research was undertaken to understand the influence of registered nurses on nursing students' learning in the clinical environment to inform strategies to enable registered nurses to provide effective support to learners while also assisting nursing students to adopt approaches to maximise their learning in the clinical environment. A case study approach was applied in this research to explore descriptions of clinical experience of five final year nursing students. The student participants identified the importance of the clinical environment to their learning and wanted to and had actively managed their learning in the clinical environment. The students did not passively acquire knowledge or simply replicate what they observed from others. There was evidence that the students had strong and established perceptions of what constituted 'good' nursing and described an ability to discriminate between differing levels of nursing practice. Nursing knowledge was gained from respected registered nurses who were best able to describe and demonstrate the 'tricks of the trade' and 'little things that matter' when providing 'good' nursing. The outcomes from this research indicate an important role for registered nurses in both shaping nursing students' professional nursing identity and access to clinical learning. Copyright © 2015 Elsevier Ltd. All rights reserved.

Views on Careers in Clinical Neurosciences Among Neurosurgeons and Neurologists in China.

PubMed

Lukas, Rimas V; Ma, Chao; Chen, Jingcao; Dong, Hongmei; Li, Jinxin; Wang, Zefen; Jiang, Ivy; Fu, Kai; Satnarayan, Samita; Albert, Dara V F; Sherer, Renslow

2017-02-01

China has a large and aging population. The need for physicians with training in clinical neurosciences will grow. There is little known regarding the factors that lead physicians in China to pursue careers in clinical neurosciences. The objective of this study was to garner a clearer understanding of factors that influence physicians to pursue careers in neurosurgery and neurology in China. We surveyed attendees at a national neuroscience conference on the factors that influence their pursuit of careers in clinical neurosciences. Responses were quantified on a Likert scale. One-way analysis of variance was used to compare different groups of respondents. Factors associated with the intellectual elements of the specialties were rated most highly. Differences were noted between respondents, with trainees rating lifestyle-related factors more highly compared with attending physicians. The intellectual challenges are important factors for physicians in China influencing the pursuit of careers in the clinical neurosciences. This finding echoes results found elsewhere in the world. However, differences with trainees elsewhere in the world emerge when evaluating additional factors influencing trainees pursuing careers in the clinical neurosciences. Trainees in China rate educational experiences and mentorship more highly, whereas U.S. trainees rate altruistic goals more highly. This study provides a clearer understanding of factors influencing career choice among clinical neuroscientists in China. Copyright © 2016 Elsevier Inc. All rights reserved.

Detailed clinical models: a review.

PubMed

Goossen, William; Goossen-Baremans, Anneke; van der Zel, Michael

2010-12-01

Due to the increasing use of electronic patient records and other health care information technology, we see an increase in requests to utilize these data. A highly level of standardization is required during the gathering of these data in the clinical context in order to use it for analyses. Detailed Clinical Models (DCM) have been created toward this purpose and several initiatives have been implemented in various parts of the world to create standardized models. This paper presents a review of DCM. Two types of analyses are presented; one comparing DCM against health care information architectures and a second bottom up approach from concept analysis to representation. In addition core parts of the draft ISO standard 13972 on DCM are used such as clinician involvement, data element specification, modeling, meta information, and repository and governance. SIX INITIATIVES WERE SELECTED: Intermountain Healthcare, 13606/OpenEHR Archetypes, Clinical Templates, Clinical Contents Models, Health Level 7 templates, and Dutch Detailed Clinical Models. Each model selected was reviewed for their overall development, involvement of clinicians, use of data types, code bindings, expressing semantics, modeling, meta information, use of repository and governance. Using both a top down and bottom up approach to comparison reveals many commonalties and differences between initiatives. Important differences include the use of or lack of a reference model and expressiveness of models. Applying clinical data element standards facilitates the use of conceptual DCM models in different technical representations.

Screening for important unwarranted variation in clinical practice: a triple-test of processes of care, costs and patient outcomes.

PubMed

Partington, Andrew; Chew, Derek P; Ben-Tovim, David; Horsfall, Matthew; Hakendorf, Paul; Karnon, Jonathan

2017-03-01

Objective Unwarranted variation in clinical practice is a target for quality improvement in health care, but there is no consensus on how to identify such variation or to assess the potential value of initiatives to improve quality in these areas. This study illustrates the use of a triple test, namely the comparative analysis of processes of care, costs and outcomes, to identify and assess the burden of unwarranted variation in clinical practice. Methods Routinely collected hospital and mortality data were linked for patients presenting with symptoms suggestive of acute coronary syndromes at the emergency departments of four public hospitals in South Australia. Multiple regression models analysed variation in re-admissions and mortality at 30 days and 12 months, patient costs and multiple process indicators. Results After casemix adjustment, an outlier hospital with statistically significantly poorer outcomes and higher costs was identified. Key process indicators included admission patterns, use of invasive diagnostic procedures and length of stay. Performance varied according to patients' presenting characteristics and time of presentation. Conclusions The joint analysis of processes, outcomes and costs as alternative measures of performance inform the importance of reducing variation in clinical practice, as well as identifying specific targets for quality improvement along clinical pathways. Such analyses could be undertaken across a wide range of clinical areas to inform the potential value and prioritisation of quality improvement initiatives. What is known about the topic? Variation in clinical practice is a long-standing issue that has been analysed from many different perspectives. It is neither possible nor desirable to address all forms of variation in clinical practice: the focus should be on identifying important unwarranted variation to inform actions to reduce variation and improve quality. What does this paper add? This paper proposes the comparative analysis of processes of care, costs and outcomes for patients with similar diagnoses presenting at alternative hospitals, using linked, routinely collected data. This triple test of performance indicators extracts maximum value from routine data to identify priority areas for quality improvement to reduce important and unwarranted variations in clinical practice. What are the implications for practitioners? The proposed analyses need to be applied to other clinical areas to demonstrate the general application of the methods. The outputs can then be validated through the application of quality improvement initiatives in clinical areas with identified important and unwarranted variation. Validated frameworks for the comparative analysis of clinical practice provide an efficient approach to valuing and prioritising actions to improve health service quality.

Analysis of internet use behaviors among clinical medical students in China.

PubMed

Yang, Hua; Chen, Yunxiang; Zheng, Liqiang; Xu, Xin; Cao, Xia

2014-04-02

The availability of internet-based information resources is increasing and the appropriate use of such resources is an important subject for clinical medical students. The aims of this study were to investigate the behaviors of clinical medical students regarding the use of internet-based activities, to analyze the behavior and characteristics of the students' information demands, and to discuss the behaviors and time preferences related to internet use of students with different levels of education. Librarians obtained real-time feedback from 999 clinical medical students to record online activities. The data was recorded in a standard form and then analyzed statistically. There were significant differences in the use of the internet for learning activities among the different groups of clinical medical students (P < 0.0001). Learning accounted for 73.5% of all internet use for doctoral candidates, 47.6% of internet use for master's candidates, 28.7% of internet use for seven-year undergraduate students, and 14.1% of use for five-year undergraduate students. There was also a significant difference in the proportions of leisure and e-commerce activities among the student groups (P < 0.0001), with five-year students displaying the highest total proportion of these activities (59.4% and 18.8%). Internet use for entertainment activities was the same for all groups of clinical medical students. Time of day of internet use was consistent across all student groups, but internet use differed by day of the week (P < 0.01). There was no difference among the time of day of internet use for learning, leisure and entertainment activities during a single day (P > 0.05), but e-commerce activities varied according to time of day (P < 0.05). Learning and e-commerce activities by clinical medical students did not vary by day of the week (P > 0.05), but the distributions of leisure and entertainment activities were different according to day of the week (P < 0.05). A stronger demand for learning is associated with a higher academic level of clinical medical students. Differences exist among student groups regarding internet use behaviors and internet use during different time periods.

TMS-EEG: From basic research to clinical applications

NASA Astrophysics Data System (ADS)

Hernandez-Pavon, Julio C.; Sarvas, Jukka; Ilmoniemi, Risto J.

2014-11-01

Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a powerful technique for non-invasively studying cortical excitability and connectivity. The combination of TMS and EEG has widely been used to perform basic research and recently has gained importance in different clinical applications. In this paper, we will describe the physical and biological principles of TMS-EEG and different applications in basic research and clinical applications. We will present methods based on independent component analysis (ICA) for studying the TMS-evoked EEG responses. These methods have the capability to remove and suppress large artifacts, making it feasible, for instance, to study language areas with TMS-EEG. We will discuss the different applications and limitations of TMS and TMS-EEG in clinical applications. Potential applications of TMS are presented, for instance in neurosurgical planning, depression and other neurological disorders. Advantages and disadvantages of TMS-EEG and its variants such as repetitive TMS (rTMS) are discussed in comparison to other brain stimulation and neuroimaging techniques. Finally, challenges that researchers face when using this technique will be summarized.

Chikungunya: an emerging viral infection with varied clinical presentations in Bangladesh: Reports of seven cases.

PubMed

Rahim, Muhammad Abdur; Uddin, Khwaja Nazim

2017-08-15

Chikungunya is an emerging and rapidly spreading viral infection in many parts of the world including Bangladesh. It shares many epidemiological and clinical characteristics with dengue. So, a sound knowledge is required for its detection and differentiation from dengue, specially in endemic regions. We present seven confirmed cases of chikungunya having different clinical presentations occurring among middle aged males and females from different socio-economic background in Dhaka city, the capital of Bangladesh. All patients had fever and aches and pains. Less common features were rash, diarrhea, vomiting and altered liver biochemistry. Dengue was excluded in six patients. Paracetamol remained the mainstay of treatment during febrile periods, but over 50% of the patients had prolonged joint symptoms requiring non-steroidal anti-inflammatory drugs. In spite of being a self-limiting disease, chikungunya may have different presentations and a protracted clinical course. During the febrile episode, exclusion of dengue is equally important. Physicians should be aware of the condition and public health initiatives are necessary to break the disease transmission.

Evaluation and applications of the clinically significant change method with the Violence Risk Scale-Sexual Offender version: implications for risk-change communication.

PubMed

Olver, Mark E; Beggs Christofferson, Sarah M; Wong, Stephen C P

2015-02-01

We examined the use of the clinically significant change (CSC) method with the Violence Risk Scale-Sexual Offender version (VRS-SO), and its implications for risk communication, in a combined sample of 945 treated sexual offenders from three international settings, followed up for a minimum 5 years post-release. The reliable change (RC) index was used to identify thresholds of clinically meaningful change and to create four CSC groups (already okay, recovered, improved, unchanged) based on VRS-SO dynamic scores and amount of change made. Outcome analyses demonstrated important CSC-group differences in 5-year rates of sexual and violent recidivism. However, when baseline risk was controlled via Cox regression survival analysis, the pattern and magnitude of CSC-group differences in sexual and violent recidivism changed to suggest that observed variation in recidivism base rates could be at least partly explained by pre-existing group differences in risk level. Implications for communication of risk-change information and applications to clinical practice are discussed. Copyright © 2015 John Wiley & Sons, Ltd.

SU-E-T-173: Clinical Comparison of Treatment Plans and Fallback Plans for Machine Downtime

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

Cruz, W; Cancer Therapy and Research Center, San Antonio, TX; Papanikolaou, P

2015-06-15

Purpose: The purpose of this study was to determine the clinical effectiveness and dosimetric quality of fallback planning in relation to machine downtime. Methods: Plans for a Varian Novalis TX were mimicked, and fallback plans using an Elekta VersaHD machine were generated using a dual arc template. Plans for thirty (n=30) patients of various treatment sites optimized and calculated using RayStation treatment planning system. For each plan, a fall back plan was created and compared to the original plan. A dosimetric evaluation was conducted using the homogeneity index, conformity index, as well as DVH analysis to determine the quality ofmore » the fallback plan on a different treatment machine. Fallback plans were optimized for 60 iterations using the imported dose constraints from the original plan DVH to give fallback plans enough opportunity to achieve the dose objectives. Results: The average conformity index and homogeneity index for the NovalisTX plans were 0.76 and 10.3, respectively, while fallback plan values were 0.73 and 11.4. (Homogeneity =1 and conformity=0 for ideal plan) The values to various organs at risk were lower in the fallback plans as compared to the imported plans across most organs at risk. Isodose difference comparisons between plans were also compared and the average dose difference across all plans was 0.12%. Conclusion: The clinical impact of fallback planning is an important aspect to effective treatment of patients. With the complexity of LINACS increasing every year, an option to continue treating during machine downtime remains an essential tool in streamlined treatment execution. Fallback planning allows the clinic to continue to run efficiently should a treatment machine become offline due to maintenance or repair without degrading the quality of the plan all while reducing strain on members of the radiation oncology team.« less

Is there a reliable factorial structure in the 20-item Toronto Alexithymia Scale? A comparison of factor models in clinical and normal adult samples.

PubMed

Müller, Jochen; Bühner, Markus; Ellgring, Heiner

2003-12-01

The 20-item Toronto Alexithymia Scale (TAS-20) is the most widely used instrument for measuring alexithymia. However, different studies did not always yield identical factor structures of this scale. The present study aims at clarifying some discrepant results. Maximum likelihood confirmatory factor analyses of a German version of the TAS-20 were conducted on data from a clinical sample (N=204) and a sample of normal adults (N=224). Five different models with one to four factors were compared. A four-factor model with factors (F1) "Difficulty identifying feelings" (F2), "Difficulty describing feelings" (F3), "Low importance of emotion" and (F4) "Pragmatic thinking" and a three-factor model with the combined factor "Difficulties in identifying and describing feelings" described the data best. Factors related to "externally oriented thinking" provided no acceptable level of reliability. Results from the present and other studies indicate that the factorial structure of the TAS-20 may vary across samples. Whether factor structures different from the common three-factor structure are an exception in some mainly clinical populations or a common phenomenon outside student populations has still to be determined. For a further exploration of the factor structure of the TAS-20 in different populations, it would be important not only to test the fit of the common three-factor model, but also to consider other competing solutions like the models of the present study.

New Edition of Chinese Biochemistry Textbook.

ERIC Educational Resources Information Center

Jian-Chuan, Ma

1988-01-01

Discusses the four previous editions of the biochemistry medical textbooks called the "Nationwide Unified Textbooks." Notes the new (1989) edition is much smaller, is organized differently, has new material, has a reorganized Dynamic Biochemistry core, and shows great importance to clinical biochemistry. (MVL)

Factors influencing emergency medicine physicians' management of sports-related concussions: a community-wide study.

PubMed

Giebel, Stephen; Kothari, Rashmi; Koestner, Amy; Mohney, Gretchen; Baker, Robert

2011-12-01

Numerous guidelines to grade and manage sports-related concussions have been published. However, little is known about how frequently they are implemented in the emergency department. This study evaluates the current practices of emergency physicians (EPs) in managing sports-related concussions. To evaluate the current practice of EP evaluation and management of sports-related concussions. All EPs and emergency medicine residents in Kalamazoo County were surveyed regarding their management of sports-related concussions. The surveys obtained demographic data, participants' use of guidelines, and the importance of clinical and non-clinical factors in deciding when to allow a player to return to play. Of the 73 EP respondents, only 23% used a nationally recognized guideline, with no significant difference between attending and resident EPs. The symptomatic complaints of loss of consciousness, amnesia of the event, and difficulty concentrating were ranked most important by EPs in assessing patients with sports-related concussions. Among non-clinical factors, residents were significantly more likely than attendings to report that medical-legal, parental, and players' concerns were more likely to influence their decision in allowing a patient to return to play. EPs take into consideration important clinical factors in assessing patients with sports-related concussion. However, almost 75% do not use any nationally recognized guideline in their evaluation. Residents are more likely than attendings to be influenced by non-clinical factors. Copyright © 2011 Elsevier Inc. All rights reserved.

Gender differences in clinicoepidemiological features of vitiligo: a cross-sectional analysis.

PubMed

Patil, Sharmila; Gautam, Manjyot; Nadkarni, Nitin; Saboo, Neha; Godse, Kiran; Setia, Maninder Singh

2014-01-01

Background. Vitiligo has important clinical and social consequences particularly in the pigmented skin. The present study was conducted to assess the differences in clinicoepidemiological presentation of vitiligo in males and females and to understand the factors associated with spread of vitiligo in them. Methods. This is a cross-sectional analysis of secondary clinical data of 168 vitiligo patients at a tertiary medical centre at Navi Mumbai. We used logistic regression models to estimate the association between gender and clinical characteristics of vitiligo and to evaluate the factors associated with spread of vitiligo. Results. There were no significant differences between the mean ages of males and females; however, males reported a longer duration of disease (6.9 (10.4) years) compared with females (4.9 (7.4) years). Males were significantly more likely to report a family history of vitiligo compared with females (adjusted OR (aOR): 16.87, 95% CI: 2.16 to 131.69). Even though females were more likely to report spread of lesions, the association was not statistically significant (OR: 1.21, 95% CI: 0.62 to 2.36). Discussion. The differences in the clinical presentations between genders highlight the need to understand the different factors (possibly genetic) that may play a part in the pathogenesis of this multifactorial disease in males and females.

Perceived Levels of Frustration During Clinical Situations in Athletic Training Students

PubMed Central

Heinerichs, Scott; Curtis, Neil; Gardiner-Shires, Alison

2014-01-01

Context: Athletic training students (ATSs) are involved in various situations during the clinical experience that may cause them to express levels of frustration. Understanding levels of frustration in ATSs is important because frustration can affect student learning, and the clinical experience is critical to their development as professionals. Objective:  To explore perceived levels of frustration in ATSs during clinical situations and to determine if those perceptions differ based on sex. Design:  Cross-sectional study with a survey instrument. Setting:  A total of 14 of 19 professional, undergraduate athletic training programs accredited by the Commission on Accreditation of Athletic Training Education in Pennsylvania. Patients or Other Participants:  Of a possible 438 athletic training students, 318 (72.6%) completed the survey. Main Outcomes Measure(s):  The Athletic Training Student Frustration Inventory was developed and administered. The survey gathered demographic information and included 24 Likert-scale items centering on situations associated with the clinical experience. Descriptive statistics were computed on all items. The Mann-Whitney U was used to evaluate differences between male and female students. Results:  A higher level of frustration was perceived during the following clinical situations: lack of respect by student-athletes and coaching staffs, the demands of the clinical experience, inability of ATSs to perform or remember skills, and ATSs not having the opportunity to apply their skills daily. Higher levels of frustration were perceived in female than male ATSs in several areas. Conclusions:  Understanding student frustration during clinical situations is important to better appreciate the clinical education experience. Low levels of this emotion are expected; however, when higher levels exist, learning can be affected. Whereas we cannot eliminate student frustrations, athletic training programs and preceptors need to be aware of this emotion in order to create an environment that is more conducive to learning. PMID:24143904

Cultural differences define diagnosis and genomic medicine practice: implications for undiagnosed diseases program in China.

PubMed

Duan, Xiaohong; Markello, Thomas; Adams, David; Toro, Camilo; Tifft, Cynthia; Gahl, William A; Boerkoel, Cornelius F

2013-09-01

Despite the current acceleration and increasing leadership of Chinese genetics research, genetics and its clinical application have largely been imported to China from the Occident. Neither genetics nor the scientific reductionism underpinning its clinical application is integral to the traditional Chinese worldview. Given that disease concepts and their incumbent diagnoses are historically derived and culturally meaningful, we hypothesize that the cultural expectations of genetic diagnoses and medical genetics practice differ between the Occident and China. Specifically, we suggest that an undiagnosed diseases program in China will differ from the recently established Undiagnosed Diseases Program at the United States National Institutes of Health; a culturally sensitive concept will integrate traditional Chinese understanding of disease with the scientific reductionism of Occidental medicine.

Post-operative ventricular flow dynamics following atrioventricular valve surgical and device therapies: A review.

PubMed

Nguyen, Yen Ngoc; Ismail, Munirah; Kabinejadian, Foad; Tay, Edgar Lik Wui; Leo, Hwa Liang

2018-04-01

Intra-ventricular flow dynamics has recently emerged as an important evaluation and diagnosis tool in different cardiovascular conditions. The formation of vortex pattern during the cardiac cycle has been suggested to play important epigenetic and energy-modulation roles in cardiac remodelling, adaptations and mal-adaptations. In this new perspective, flow alterations due to different cardiovascular procedures can affect the long-term outcome of those procedures. Especially, repairs and replacements performed on atrioventricular valves are likely to exert direct impact on intra-ventricular flow pattern. In this review, current consensus around the roles of vortex dynamics in cardiac function is discussed. An overview of physiological vortex patterns found in healthy left and right ventricles as well as post-operative ventricular flow phenomenon owing to different atrioventricular valvular procedures are reviewed, followed by the summary of different vortex identification schemes used to characterise intraventricular flow. This paper also emphasises on future research directions towards a comprehensive understanding of intra-cardiac flow and its clinical relevance. The knowledge could encourage more effective pre-operative planning and better outcomes for current clinical practices. Copyright © 2018. Published by Elsevier Ltd.

Practical considerations in the management of proton-pump inhibitors.

PubMed

Aguilera-Castro, Lara; Martín-de-Argila-dePrados, Carlos; Albillos-Martínez, Agustín

2016-03-01

Proton-pump inhibitors (PPIs) are one of the most active ingredients prescribed in Spain. In recent decades there has been an overuse of these drugs in both outpatient clinics and hospitals that has lead to a significant increase in healthcare spending and to an increase in the risk of possible side effects. It is important for health professionals to know the accepted indications and the correct doses for the use of these drugs. On the market there are different types of PPI: omeprazole, pantoprazole, lansoprazole, rabeprazole and esomeprazole. Omeprazole is the oldest and most used PPI, being also the cheapest. Although there are no important differences between PPIs in curing diseases, esomeprazole, a new-generation PPI, has proved to be more effective in eradicating H. pylori and in healing severe esophagitis compared to other PPIs. In recent years the use of generic drugs has spread; these drugs have the same bioavailability than the original drugs. In the case of PPIs, the few comparative studies available in the literature between original and generic drugs have shown no significant differences in clinical efficacy.

Heterogeneous patterns of brain atrophy in Alzheimer's disease.

PubMed

Poulakis, Konstantinos; Pereira, Joana B; Mecocci, Patrizia; Vellas, Bruno; Tsolaki, Magda; Kłoszewska, Iwona; Soininen, Hilkka; Lovestone, Simon; Simmons, Andrew; Wahlund, Lars-Olof; Westman, Eric

2018-05-01

There is increasing evidence showing that brain atrophy varies between patients with Alzheimer's disease (AD), suggesting that different anatomical patterns might exist within the same disorder. We investigated AD heterogeneity based on cortical and subcortical atrophy patterns in 299 AD subjects from 2 multicenter cohorts. Clusters of patients and important discriminative features were determined using random forest pairwise similarity, multidimensional scaling, and distance-based hierarchical clustering. We discovered 2 typical (72.2%) and 3 atypical (28.8%) subtypes with significantly different demographic, clinical, and cognitive characteristics, and different rates of cognitive decline. In contrast to previous studies, our unsupervised random forest approach based on cortical and subcortical volume measures and their linear and nonlinear interactions revealed more typical AD subtypes with important anatomically discriminative features, while the prevalence of atypical cases was lower. The hippocampal-sparing and typical AD subtypes exhibited worse clinical progression in visuospatial, memory, and executive cognitive functions. Our findings suggest there is substantial heterogeneity in AD that has an impact on how patients function and progress over time. Copyright © 2018 Elsevier Inc. All rights reserved.

“They put you on your toes”: Physical Therapists' Perceived Benefits from and Barriers to Supervising Students in the Clinical Setting

PubMed Central

Hanna, Elizabeth; Cott, Cheryl

2011-01-01

ABSTRACT Purpose: To identify the perceived benefits of and barriers to clinical supervision of physical therapy (PT) students. Method: In this qualitative descriptive study, three focus groups and six key-informant interviews were conducted with clinical physical therapists or administrators working in acute care, orthopaedic rehabilitation, or complex continuing care. Data were coded and analyzed for common ideas using a constant comparison approach. Results: Perceived barriers to supervising students tended to be extrinsic: time and space constraints, challenging or difficult students, and decreased autonomy or flexibility for the clinical physical therapists. Benefits tended to be intrinsic: teaching provided personal gratification by promoting reflective practice and exposing clinical educators to current knowledge. The culture of different health care institutions was an important factor in therapists' perceptions of student supervision. Conclusions: Despite different disciplines and models of supervision, there is considerable synchronicity in the issues reported by physical therapists and other disciplines. Embedding the value of clinical teaching in the institution, along with strong communication links among academic partners, institutions, and potential clinical faculty, may mitigate barriers and increase the commitment and satisfaction of teaching staff. PMID:22379263

The contribution of clinical leadership to service redesign: a naturalistic inquiry.

PubMed

Storey, John; Holti, Richard

2012-08-01

Numerous policy papers and academic contributions across a range of countries emphasize the importance of clinical leadership in health services. This is seen as especially vital at a time of simultaneous resource constraints and rising demand. Most of the literature in this topic area concerns itself with conceptual clarification of types of leadership and with delineation of requisite competences. But other work on leadership has emphasized the importance of attending to practice in concrete situations in order to identify the dynamics at play and the nature of the challenges. The purpose of this article is to contribute to this latter task by drawing upon a set of data which reveals crucial aspects of the problems facing potential clinical leaders of service redesign. This paper reports on the nature and extent of the challenges as identified by clinicians of different types as well as managers and commissioners.

Minimum Information about T Regulatory Cells: A Step toward Reproducibility and Standardization.

PubMed

Fuchs, Anke; Gliwiński, Mateusz; Grageda, Nathali; Spiering, Rachel; Abbas, Abul K; Appel, Silke; Bacchetta, Rosa; Battaglia, Manuela; Berglund, David; Blazar, Bruce; Bluestone, Jeffrey A; Bornhäuser, Martin; Ten Brinke, Anja; Brusko, Todd M; Cools, Nathalie; Cuturi, Maria Cristina; Geissler, Edward; Giannoukakis, Nick; Gołab, Karolina; Hafler, David A; van Ham, S Marieke; Hester, Joanna; Hippen, Keli; Di Ianni, Mauro; Ilic, Natasa; Isaacs, John; Issa, Fadi; Iwaszkiewicz-Grześ, Dorota; Jaeckel, Elmar; Joosten, Irma; Klatzmann, David; Koenen, Hans; van Kooten, Cees; Korsgren, Olle; Kretschmer, Karsten; Levings, Megan; Marek-Trzonkowska, Natalia Maria; Martinez-Llordella, Marc; Miljkovic, Djordje; Mills, Kingston H G; Miranda, Joana P; Piccirillo, Ciriaco A; Putnam, Amy L; Ritter, Thomas; Roncarolo, Maria Grazia; Sakaguchi, Shimon; Sánchez-Ramón, Silvia; Sawitzki, Birgit; Sofronic-Milosavljevic, Ljiljana; Sykes, Megan; Tang, Qizhi; Vives-Pi, Marta; Waldmann, Herman; Witkowski, Piotr; Wood, Kathryn J; Gregori, Silvia; Hilkens, Catharien M U; Lombardi, Giovanna; Lord, Phillip; Martinez-Caceres, Eva M; Trzonkowski, Piotr

2017-01-01

Cellular therapies with CD4+ T regulatory cells (Tregs) hold promise of efficacious treatment for the variety of autoimmune and allergic diseases as well as posttransplant complications. Nevertheless, current manufacturing of Tregs as a cellular medicinal product varies between different laboratories, which in turn hampers precise comparisons of the results between the studies performed. While the number of clinical trials testing Tregs is already substantial, it seems to be crucial to provide some standardized characteristics of Treg products in order to minimize the problem. We have previously developed reporting guidelines called minimum information about tolerogenic antigen-presenting cells, which allows the comparison between different preparations of tolerance-inducing antigen-presenting cells. Having this experience, here we describe another minimum information about Tregs (MITREG). It is important to note that MITREG does not dictate how investigators should generate or characterize Tregs, but it does require investigators to report their Treg data in a consistent and transparent manner. We hope this will, therefore, be a useful tool facilitating standardized reporting on the manufacturing of Tregs, either for research purposes or for clinical application. This way MITREG might also be an important step toward more standardized and reproducible testing of the Tregs preparations in clinical applications.

Systemic Sclerosis Disease Modification Clinical Trials Design: Quo Vadis?

PubMed Central

Mendoza, Fabian A.; Keyes-Elstein, Lynette L.; Jimenez, Sergio A.

2012-01-01

The purpose of this manuscript is to discuss relevant aspects of clinical trials for Systemic Sclerosis (SSc) and to identify important considerations for the design of SSc disease modification clinical trials. Placebo randomized controlled trials with appropriate identification of SSc patients with diffuse progressive SSc skin involvement of recent onset, along with a rescue strategy for patients with worsening lung and skin involvement are suggested. If change in skin thickening is a major outcome of the study, the selection of patients with recent onset of disease and a predetermined degree of skin involvement are crucial requirements. The trial duration should be of at least 12 months. Sample size calculations should consider differences that exceed the Minimal Important Difference. Other relevant trial designs and potential threats to study validity are also discussed. Previous SSc-disease modifying trials have been beset by high dropout rates. Analyses on the subset of subjects completing the trial or applying the last-observation-carried-forward approach can potentially lead to biased estimates and false conclusions. Strategies for retention of subjects should be included at the design stage and analyses to account for missing data should be performed. PMID:22422541

Monitoring microcirculation.

PubMed

Ocak, Işık; Kara, Atila; Ince, Can

2016-12-01

The clinical relevance of microcirculation and its bedside observation started gaining importance in the 1990s since the introduction of hand-held video microscopes. From then, this technology has been continuously developed, and its clinical relevance has been established in more than 400 studies. In this paper, we review the different types of video microscopes, their application techniques, the microcirculation of different organ systems, the analysis methods, and the software and scoring systems. The main focus of this review will be on the state-of-art technique, CytoCam-incident dark-field imaging, and the most recent technological and technical updates concerning microcirculation monitoring. Copyright © 2016 Elsevier Ltd. All rights reserved.

[A new strategy for Chinese medicine processing technologies: coupled with individuation processed and cybernetics].

PubMed

Zhang, Ding-kun; Yang, Ming; Han, Xue; Lin, Jun-zhi; Wang, Jia-bo; Xiao, Xiao-he

2015-08-01

The stable and controllable quality of decoction pieces is an important factor to ensure the efficacy of clinical medicine. Considering the dilemma that the existing standardization of processing mode cannot effectively eliminate the variability of quality raw ingredients, and ensure the stability between different batches, we first propose a new strategy for Chinese medicine processing technologies that coupled with individuation processed and cybernetics. In order to explain this thinking, an individual study case about different grades aconite is provided. We hope this strategy could better serve for clinical medicine, and promote the inheritance and innovation of Chinese medicine processing skills and theories.

Las experiencias clinicas de los estudiantes de enfermeria: Estudio de caso hacia la integracion de la mentoria

NASA Astrophysics Data System (ADS)

Rivera Rodriguez, Ivelisse

Clinical experiences are an essential part of the training of future nursing professionals. The period of clinical experience aims to develop in the student the necessary skills to practice as a nursing professional, when the academic program ends. This case study aimed to understand the opinion and explore the perception of faculty, clinical instructors, and nursing students on the meaning, contributions and challenges presented during clinical experiences. Among the themes explored in the focus groups were the meaning and importance to learning about the profession of clinical experiences, teaching strategies used during the practice scenarios, didactic relationships developed among students, clinical instructors, and teachers. The goal was to learn from all participants about what they do, their expectations, and the challenges presented during the clinical experiences. A qualitative, descriptive and contextual research design was followed, which required conducting six focus groups to collect the information from the perspective of all the participants. Faculty, clinical instructors, and nursing students participated each in two focus groups. Collected data were transcribed, coded and analyzed in order to organize it under themes related to the research framework. The qualitative analysis of the focus groups revealed that nursing faculty and clinical instructors perceived clinical experiences as a very important element in the training of nursing students, but that coordination between the academy and practice scenarios is disconnected and needs improvement. They also expressed that they use various learning strategies during the clinical experiences, however, they recognize it needs more structure and suggested mentoring as a strategy to consider. They affirmed that mentoring could contribute positively to enhance the teaching-learning process. Clinical instructors understand they perform mentoring roles, but they would like to have a more defined role and structured process. Nursing students, also, recognized the importance of clinical experiences in their professional training. They expressed the need to improve the communication between the academy and the practice scenarios in order to reduce the levels of anxiety they experience when entering the clinical experiences. Nursing students also expressed the need to consider the use of different teaching strategies, such as mentoring, to improve clinical experiences.

How Do Clinical Information Systems Affect the Cognitive Demands of General Practitioners?: Usability Study with a Focus on Cognitive Workload.

PubMed

Ariza, Ferran; Kalra, Dipak; Potts, Henry Ww

2015-11-20

Clinical information systems in the National Health Service do not need to conform to any explicit usability requirements. Poor usability can increase the mental workload experienced by clinicians and cause fatigue, increase error rates and impact the overall patient safety. Mental workload can be used as a measure of usability. To assess the subjective cognitive workload experienced by general practitioners (GPs) with their systems. To raise awareness of the importance of usability in system design among users, designers, developers and policymakers. We used a modified version of the NASA Task Load Index, adapted for web. We developed a set of common clinical scenarios and computer tasks on an online survey. We emailed the study link to 199 clinical commissioning groups and 1,646 GP practices in England. Sixty-seven responders completed the survey. The respondents had spent an average of 17 years in general practice, had experience of using a mean of 1.5 GP computer systems and had used their current system for a mean time of 6.7 years. The mental workload score was not different among systems. There were significant differences among the task scores, but these differences were not specific to particular systems. The overall score and task scores were related to the length of experience with their present system. Four tasks imposed a higher mental workload on GPs: 'repeat prescribing', 'find episode', 'drug management' and 'overview records'. Further usability studies on GP systems should focus on these tasks. Users, policymakers, designers and developers should remain aware of the importance of usability in system design.What does this study add?• Current GP systems in England do not need to conform to explicit usability requirements. Poor usability can increase the mental workload of clinicians and lead to errors.• Some clinical computer tasks incur more cognitive workload than others and should be considered carefully during the design of a system.• GPs did not report overall very high levels of subjective cognitive workload when undertaking common clinical tasks with their systems.• Further usability studies on GP systems should focus on the tasks incurring higher cognitive workload.• Users, policymakers, and designers and developers should remain aware of the importance of usability in system design.

Iridocorneal endothelial syndrome: clinical perspectives

PubMed Central

Walkden, Andrew; Au, Leon

2018-01-01

This article aims to review the clinical management strategies available for the rare iridocorneal endothelial syndrome. The different clinical variations as well as the imaging techniques available to aid diagnosis are discussed. We then present the evidence available to help the reader to understand how the condition can be managed medically and also the important surgical aspects of treatment. This involves raised intraocular pressure management in addition to the visual management options of partial or full thickness keratoplasty. We hope that this review provides an exhaustive but also succinct review of the literature available on what is a rare and difficult condition to treat. PMID:29670326

[Diagnosis of dementia in non-western elderly migrants in memory clinics: obstacles and solutions].

PubMed

Goudsmit, M; Parlevliet, J L; van Campen, J P C M; Schmand, B

2011-10-01

In the next decade the number of non-western elderly immigrants will double in the Netherlands. Because of specific risk factors (hypertension, diabetes), the number of elderly immigrants with dementia will probably increase. Memory clinics are not well prepared for these patients, because health professionals lack knowledge about important obstacles in intercultural dementia diagnostics. They should consider language barriers, cultural differences, low level of education and illiteracy, as well as ignorance about dementia, shame and special care expectations of patients and their families. We give recommendations to improve communication, (neuropsychological) testing and counseling in clinical practice.

Anxiety in medical students: is preparation for full-time clinical attachments more dependent upon differences in maturity or on educational programmes for undergraduate and graduate entry students?

PubMed

Hayes, K; Feather, A; Hall, A; Sedgwick, P; Wannan, G; Wessier-Smith, A; Green, T; McCrorie, P

2004-11-01

The transition to full-time clinical studies holds anxieties for most medical students. While graduate entry medical education has only recently begun in the UK, the parallel undergraduate and graduate entry MBBS courses taught at our school allowed us to study how 2 differently prepared groups perceived this vital time at a comparable stage in their training. An anonymous questionnaire collected demographic data and graded anxiety in 13 statements relating to starting full-time clinical attachments. Two open questions allowed free text comment on the most positive and negative influences perceived during this time. Both a statistical analysis and a qualitative assessment were performed to compare the 2 groups of students. The 2 groups were similar with respect to gender but the graduate entry students were significantly older. The graduate entry students were significantly less anxious about most aspects of the transition period compared to the undergraduates. These course differences remained after adjusting for age and sex. When adjusted for course and age, male students expressed less anxiety. The main positive qualitative statements related to continual clinical and communication skills training in the graduate entry group. The main qualitative concerns in both groups related to 'fitting in' and perceived lack of factual knowledge. These data support the early introduction of clinical skills teaching, backed up by a fully integrated clinically relevant curriculum with continued assessment, in preparing students and reducing levels of anxiety before they start full-time clinical attachments. These course design differences appear to be more important than any differences in maturity between the 2 groups.

A pilot single-blind multicentre randomized controlled trial to evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on the arm function of children with spastic cerebral palsy.

PubMed

Preston, Nick; Weightman, Andrew; Gallagher, Justin; Levesley, Martin; Mon-Williams, Mark; Clarke, Mike; O'Connor, Rory J

2016-10-01

To evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on arm function of children with spastic cerebral palsy. A single-blind randomized controlled trial design. Power calculations indicated that 58 children would be required to demonstrate a clinically important difference. Intervention was home-based; recruitment took place in regional spasticity clinics. A total of 15 children with cerebral palsy aged five to 12 years were recruited; eight to the device group. Both study groups received 'usual follow-up treatment' following spasticity treatment with botulinum toxin; the intervention group also received a rehabilitation gaming device. ABILHAND-kids and Canadian Occupational Performance Measure were performed by blinded assessors at baseline, six and 12 weeks. An analysis of covariance showed no group differences in mean ABILHAND-kids scores between time points. A non-parametric analysis of variance on Canadian Occupational Performance Measure scores showed a statistically significant improvement across time points (χ 2 (2,15) = 6.778, p = 0.031), but this improvement did not reach minimal clinically important difference. Mean daily device use was seven minutes. Recruitment did not reach target owing to unanticipated staff shortages in clinical services. Feedback from children and their families indicated that the games were not sufficiently engaging to promote sufficient use that was likely to result in functional benefits. This study suggests that computer-assisted arm rehabilitation gaming does not benefit arm function, but a Type II error cannot be ruled out. © The Author(s) 2015.

Variability in the quality of overdose advice in Summary of Product Characteristics (SPC) documents: gut decontamination recommendations for CNS drugs.

PubMed

Wall, Andrew J B; Bateman, D N; Waring, W S

2009-01-01

Deliberate self-poisoning is a major cause of morbidity and mortality. The Summary of Product Characteristics (SPC) document is a legal requirement for all drugs, and Section 4.9 addresses the features of toxicity and clinical advice on management of overdose. The quality and appropriateness of this advice have received comparatively little attention. Section 4.9 of the SPC was examined for all drugs in the central nervous system (CNS) category of the British National Formulary. Advice concerning gut decontamination was examined with respect to specific interventions: induced vomiting, oral activated charcoal, gastric lavage, and other interventions. Data were compared with standard reference sources for clinical management advice in poisoning. These were graded 'A' if no important differences existed, 'B' if differences were noted but not thought clinically important, and 'C' if differences were thought to be clinically significant. SPC documents were examined for 258 medications from 67 manufacturers. The overall agreement was 'A' in 23 (8.9%), 'B' in 28 (10.9%) and 'C' in 207 (80.2%). Discrepancies were due to inappropriate recommendation of induced emesis in 21.7% (95% confidence interval 17.1, 27.1), gastric lavage in 38.4% (32.7, 44.4), other gut decontamination in 5.8% (3.6, 9.4) and failure to recommend oral activated charcoal in 57.4% (51.1, 63.4). Gut decontamination advice in SPC documents with respect to CNS drugs was inadequate. Possible reasons for the observed discrepancies and ways of improving the consistency of advice are proposed.

Individual variability in clinical effect and tolerability of opioid analgesics - Importance of drug interactions and pharmacogenetics.

PubMed

Solhaug, Vigdis; Molden, Espen

2017-10-01

As pain is often a comorbid condition, many patients use opioid analgesics in combination with several other drugs. This implies a generally increased risk of drug interactions, which along with inherent pharmacogenetic variability and other factors may cause differences in therapeutic response of opioids. To provide an overview of interactions and pharmacogenetic variability of relevance for individual differences in effect and tolerability of opioid analgesics, which physicians and other healthcare professionals should be aware of in clinical practice. The article was based on unsystematic searches in PubMed to identify literature highlighting the clinical impact of drug interactions and pharmacogenetics as sources of variable response of opioid analgesics. Cytochrome P450 (CYP)-mediated metabolism is an important process for both clinically relevant interactions and pharmacogenetic variability of several opioids. Concomitant use of CYP inhibitors (e.g. paroxetine, fluoxetine and bupropion) or inducers (e.g. carbamazepine, phenobarbital and phenytoin) could counteract the clinical effect or trigger side effects of analgesics in the same manner as genetically determined differences in CYP2D6-mediated metabolism of many opioids. Moreover, combination treatment with drugs that inhibit or induce P-glycoprotein (ABCB1), a blood-brain barrier efflux transporter, may alter the amount ('dose') of opioids distributed to the brain. At the pharmacodynamic level, it is crucial to be aware of the potential risk of interaction causing serotonergic syndrome when combining opioids and serotonergic drugs, in particular antidepressants inhibiting serotonin reuptake (SSRIs and SNRIs). Regarding pharmacogenetics at the receptor level of pain treatment, the knowledge is currently scarce, but an allelic variant of the μ1 opioid receptor (OPRM1) gene has been associated with higher dosage requirement to achieve analgesia. Drug interactions and pharmacogenetic differences may lead to therapeutic failure or serious side effects of opioid analgesics. Many interactions involve combinations with antidepressants and antiepileptics, which are highly relevant drugs in patients suffering from pain. To prevent unfavourable drug interactions it is important that clinicians pay close attention and use electronic drug interaction checkers when treatments are initiated or discontinued. For the management of issues related to pharmacogenetic differences, blood-based CYP genotyping is available as routine test at many laboratories, and provide a valuable tool for proper choice of drugs and doses for treatment of pain and other diseases. Copyright © 2017 Scandinavian Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

The relationship between senior management team culture and clinical governance: Empirical investigation and managerial implications.

PubMed

Prenestini, Anna; Calciolari, Stefano; Lega, Federico; Grilli, Roberto

2015-01-01

Health care organizations are pressured to improve the cost-effectiveness of service delivery. Clinical governance is an important trigger to improve care quality and safety and rank high in the reform agenda of health systems. The senior management team culture plays a major role in establishing clinical governance practices, because it strongly influences the values, attitudes, and behaviors of the members of an organization. The aim of this study was to investigate the relationship between senior management team culture and clinical governance in the public health care organizations of three Italian regions. The assessment of senior management culture was conducted using the Competing Values Framework and a corresponding instrument adapted for the Italian context. Clinical governance was assessed using an ad hoc instrument focused on the senior management team's perception and attitude toward clinical governance. The survey achieved a 54% response rate. The results of four different models demonstrate that organizations characterized by different dominant cultures are associated with significant differences in attitudes toward clinical governance. In particular, on average, dominant cultures with a prevailing external focus are associated with a more positive attitude toward clinical governance. The selection and appointments of top managers should consider the style of leadership that is most apt to facilitate the growth of rational and developmental cultures. Furthermore, the training of top managers and leading doctors should reinforce leadership aptitude and approaches that are consistent with the desired organizational cultures.

Gender differences in brain activity and the relationship between brain activity and differences in prevalence rates between male and female major depressive disorder patients: a resting-state fMRI study.

PubMed

Yao, Zhijian; Yan, Rui; Wei, Maobin; Tang, Hao; Qin, Jiaolong; Lu, Qing

2014-11-01

We examined the gender-difference effect on abnormal spontaneous neuronal activity of male and female major depressive disorder (MDD) patients using the amplitude of low-frequency fluctuation (ALFF) and the further clarified the relationship between the abnormal ALFF and differences in MDD prevalence rates between male and female patients. Fourteen male MDD patients, 13 female MDD patients and 15 male and 15 female well matched healthy controls (HCs) completed this study. The ALFF approach was used, and Pearson correlation was conducted to observe a possible clinical relevance. There were widespread differences in ALFF values between female and male MDD patients, including some important parts of the frontoparietal network, auditory network, attention network and cerebellum network. In female MDD patients, there was a positive correlation between average ALFF values of the left postcentral gyrus and the severity of weight loss symptom. The gender-difference effect leading to abnormal brain activity is an important underlying pathomechanism for different somatic symptoms in MDD patients of different genders and is likely suggestive of higher MDD prevalence rates in females. The abnormal ALFF resulting from the gender-difference effect might improve our understanding of the differences in prevalence rates between male and female MDD patients from another perspective. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Practice education learning environments: the mismatch between perceived and preferred expectations of undergraduate health science students.

PubMed

Brown, Ted; Williams, Brett; McKenna, Lisa; Palermo, Claire; McCall, Louise; Roller, Louis; Hewitt, Lesley; Molloy, Liz; Baird, Marilyn; Aldabah, Ligal

2011-11-01

Practical hands-on learning opportunities are viewed as a vital component of the education of health science students, but there is a critical shortage of fieldwork placement experiences. It is therefore important that these clinical learning environments are well suited to students' perceptions and expectations. To investigate how undergraduate students enrolled in health-related education programs view their clinical learning environments and specifically to compare students' perception of their 'actual' clinical learning environment to that of their 'preferred/ideal' clinical learning environment. The Clinical Learning Environment Inventory (CLEI) was used to collect data from 548 undergraduate students (55% response rate) enrolled in all year levels of paramedics, midwifery, radiography and medical imaging, occupational therapy, pharmacy, nutrition and dietetics, physiotherapy and social work at Monash University via convenience sampling. Students were asked to rate their perception of the clinical learning environment at the completion of their placements using the CLEI. Satisfaction of the students enrolled in the health-related disciplines was closely linked with the five constructs measured by the CLEI: Personalization, Student Involvement, Task Orientation, Innovation, and Individualization. Significant differences were found between the student's perception of their 'actual' clinical learning environment and their 'ideal' clinical learning environment. The study highlights the importance of a supportive clinical learning environment that places emphasis on effective two-way communication. A thorough understanding of students' perceptions of their clinical learning environments is essential. Copyright © 2010 Elsevier Ltd. All rights reserved.

Diversity in mental fatigue and social profile of patients with myasthenia gravis in two different Northern European countries.

PubMed

Sabre, Liis; Westerberg, Elisabet; Liik, Maarika; Punga, Anna R

2017-04-01

Self-estimated health can be used for comparison of different diseases between countries. It is important to elaborate on whether disparities in self-estimated health are due to disease-specific parameters or socioeconomic differences. In this study, we aimed at evaluating clinical and social similarities and differences in myasthenia gravis (MG) patients between comparable regions in two Baltic Sea countries, Estonia and Sweden. This cross-sectional study included southern counties in Sweden and Estonia of comparable size. All patients with a confirmed MG diagnosis were asked to answer two questionnaires including demographic and disease-specific data, lifestyle issues, and mental fatigue (Fatigue Severity Scale [FSS]). Clinical fatigue was assessed objectively through the Quantitative Myasthenia Gravis Score (QMG). Thirty-six of 92 identified patients in Estonia and 40 of 70 identified MG patients in Sweden chose to participate in the study. The demographic characteristics and symptoms reported by the patients were similar. QMG score did not differ; however, the Estonian patients scored their current subjective disease severity significantly higher (5.6 ± 2.8) compared to the Swedish patients (3.4 ± 2.3, p  = .0005). Estonian patients also had significantly higher FSS scores (5.0 ± 1.7) than Swedish patients (3.5 ± 1.6; p  = .001). Swedish patients were more active and performed physical activity more regularly (29.1% in Estonia and 74.2% in Sweden, p  = .004). Although, the patients had comparable clinical fatigue, Estonian patients evaluated their health state as being more severe and reported more mental fatigue than Swedish patients. These data indicate large regional differences in disease perception of MG, which is important to consider in international studies.

The role of ethics in pediatrics.

PubMed

Cooke, Robert E

1975-10-01

Medical ethics has increased in importance in medical education and practice as a consequence of advances in definitive treatment of patients. Most problems in ethics related to medicine have certain common denominators. Medical scientists and practitioners frequently disclaim any ethical absolutes or consider as important only nonmoral consequences rather than ethical principles such as justice, noninjury, truth-telling, etc. Failure to differentiate moral from nonmoral decisions as well as differences in level of moral reasoning also account for substantial differences in analyzing a given clinical problem. Finally, individual moral policy may be rendered ineffective because of institutional policies that result from purely pragmatic considerations.

Structural similarities and differences between the human and the mouse pancreas

PubMed Central

Dolenšek, Jurij; Rupnik, Marjan Slak; Stožer, Andraž

2015-01-01

Mice remain the most studied animal model in pancreas research. Since the findings of this research are typically extrapolated to humans, it is important to understand both similarities and differences between the 2 species. Beside the apparent difference in size and macroscopic organization of the organ in the 2 species, there are a number of less evident and only recently described differences in organization of the acinar and ductal exocrine tissue, as well as in the distribution, composition, and architecture of the endocrine islets of Langerhans. Furthermore, the differences in arterial, venous, and lymphatic vessels, as well as innervation are potentially important. In this article, the structure of the human and the mouse pancreas, together with the similarities and differences between them are reviewed in detail in the light of conceivable repercussions for basic research and clinical application. PMID:26030186

Valuing hope.

PubMed

McMillan, John; Walker, Simon; Hope, Tony

2014-01-01

This article argues that hope is of value in clinical ethics and that it can be important for clinicians to be sensitive to both the risks of false hope and the importance of retaining hope. However, this sensitivity requires an understanding of the complexity of hope and how it bears on different aspects of a well-functioning doctor-patient relationship. We discuss hopefulness and distinguish it, from three different kinds of hope, or 'hopes for', and then relate these distinctions back to differing accounts of autonomy. This analysis matters because it shows how an overly narrow view of the ethical obligations of a clinician to their patient, and autonomy, might lead to scenarios where patients regret the choices they make.

Differences in vision between clinic and home and the effect of lighting in older adults with and without glaucoma

PubMed Central

Bhorade, Anjali M.; Perlmutter, Monica S.; Wilson, Brad; Kambarian, Jamie; Chang, Sidney; Pekmezci, Melike; Gordon, Mae

2015-01-01

Importance Patients often report greater visual difficulties at home than expected from vision testing in the clinic. Such discordance may be due to worse vision in the home than measured in clinic. Objective To compare vision measured between clinic and home and evaluate factors, including lighting, associated with these differences. Design Cross-sectional, between years 2005–2009. Setting Participants recruited from the Glaucoma and Comprehensive Eye Clinics at Washington University, St. Louis, MO underwent a clinic and home visit. Participants 126 glaucoma and 49 non-glaucoma patients, ages 55–90 years, consecutively recruited and met inclusion criteria for this report; 166 eligible patients refused participation. Exposure Participants underwent a clinic and home visit randomized to order of completion. At each visit, masked and certified examiners measured binocular distance visual acuity (DVA) with a non-backlit chart, near visual acuity (NVA), contrast sensitivity (CS), CS with glare, and lighting. Main Outcome Measure Differences in vision between clinic and home. Results Mean scores for all vision tests were significantly better in the clinic than home for glaucoma and non-glaucoma patients (p<0.05, matched pair t-tests). For DVA, 29% of glaucoma participants read ≥2 lines better in clinic than home and 39% with advanced glaucoma read ≥3 lines better. For the entire sample, 21% of participants read ≥2 lines better in clinic than home for NVA and 49% read ≥2 triplets better in clinic for CS with glare. Lighting was the most significant factor associated with differences in vision between clinic and home for DVA, NVA, and CS with glare testing (p<0.05 multiple regression model). Median home lighting was 4.3 times and 2.8 times lower than clinic lighting in areas tested for DVA and NVA, respectively. Home lighting was below that recommended in ≥ 85% of participants. Conclusions and Relevance Vision measured in the clinic is generally better than vision measured at home, with differences mainly due to poor home lighting. Knowledge that vision discrepancies between patient report and clinical testing may be due to home lighting may initiate clinician-patient discussions to increase home lighting and improve vision of older adults in their homes. PMID:24263699

The development and piloting of a leadership questionnaire for general dental practitioners: preliminary results from the North West of England and Tokyo.

PubMed

Brocklehurst, P; O'Malley, L; Hill, H; Ozaki, T; Nomura, M; Matsuda, R

2014-11-01

Key reforms in England and Japan have called for greater clinical leadership from general dental practitioners to deliver improvements in the quality of care for patients. In England, the reorganisation of the National Health Service has led to the development of Local Professional Networks to ensure services are clinically led, patient and outcome focused. In Japan, the rapidly changing demographics have led to calls for general dental practitioners to become more active in meeting the emerging population health challenges. Both require engagement at a strategic and a local level. However, little is known about what is meant by clinical leadership in dentistry or what training needs exist. The aim of this study was to develop and pilot a questionnaire to understand what general dental practitioners feel is important about clinical leadership and how they rate themselves. A 61-item questionnaire was developed from the literature, an earlier qualitative study and refined through cognitive interviews. Questionnaires were distributed to general dental practitioners across the North West of England and Tokyo, using random sequence generation. For each item, the participant had to record whether they thought the statement was an important component of clinical leadership and how they rated themselves. Both were rated using a seven-point Likert scale. Data reduction was undertaken using principal component analysis to examine for factor loadings within the questionnaire. Differences in mean scores were also used to highlight substantive differences in how general dental practitioners rated the different components of leadership and how they rated themselves. The response rate for the pilot was low (22.9% and 7.5% for North West and Tokyo respectively). The items that were considered to be important in leadership reduced to two components in the North West (accounting for 62.1% of the total variance): 'How to lead' and 'How not to lead'. In Tokyo, 56.4% of the total variance was explained by three components: 'Demonstrating personal qualities', 'Working with others' and 'How not to lead'. When the self-rated items were reduced, three factors were found to be important in the North West: 'Working with others', 'Setting direction' and 'Managing services' (55.1% of the variance). 'Working with others', 'Demonstrating personal qualities', 'Pragmatism', 'Setting direction' and 'Improving services' were found to be important in Tokyo (52.8% of the variance). The questionnaire items relating to integrity, team-working and having a positive attitude during difficult times were rated highly by both groups. Items relating to providing vision for team, being assertive and having a positive attitude had the greatest mean difference, suggesting possible areas of training need. The nature of the pilot study and the poor response rate makes any conclusion difficult to infer. Among those that participated, leadership was understood to be more important at a practice level rather than at a strategic level. The questionnaire should be refined further based on the results of the pilot and the data reduction.

Promoting public awareness of randomised clinical trials using the media: the ‘Get Randomised’ campaign

PubMed Central

Mackenzie, Isla S; Wei, Li; Rutherford, Daniel; Findlay, Evelyn A; Saywood, Wendy; Campbell, Marion K; MacDonald, Thomas M

2010-01-01

AIM To increase public awareness and understanding of clinical research in Scotland. METHODS A generic media campaign to raise public awareness of clinical research was launched in 2008. The ‘Get Randomised’ campaign was a Scotland-wide initiative led by the University of Dundee in collaboration with other Scottish universities. Television, radio and newspaper advertising showed leading clinical researchers, general practitioners and patients informing the public about the importance of randomised clinical trials (RCTs). ‘Get Randomised’ was the central message and interested individuals were directed to the http://www.getrandomised.org website for more information. To assess the impact of the campaign, cross-sectional surveys were conducted in representative samples of 1040 adults in Scotland prior to campaign launch and again 6 months later. RESULTS There was an improvement in public awareness of clinical trials following the campaign; 56.7% [95% confidence interval (CI) 51.8, 61.6] of the sample recalled seeing or hearing advertising about RCTs following the campaign compared with 14.8% (10.8, 18.9) prior to the campaign launch (difference = 41.4%; 95% CI for difference 35.6, 48.3; P < 0.01). Of those who recalled the advertising, 49% felt that the main message was that people should take part more in medical research. However, on whether they would personally take part in a clinical trial if asked, there was little difference in response following the campaign [‘yes’ 31.3% (28.4, 34.1) prior; 30.4% (27.6, 33.2) following; difference =−0.9%; 95% CI for difference −4.8, 3.1%; P= 0.92]. CONCLUSIONS It is possible to raise public awareness of clinical research using the media, but further efforts may be required to influence individuals' decisions to take part in clinical research. PMID:20233175

[Clinical use of interventional MR imaging].

PubMed

Kahn, Thomas; Schulz, Thomas; Moche, Michael; Prothmann, Sascha; Schneider, Jens-Peter

2003-01-01

The integration of diagnostic and therapeutic procedures by MRI is based on the combination of excellent morphologic and functional imaging. The spectrum of MR-guided interventions includes biopsies, thermal ablation procedures, vascular applications, and intraoperative MRI. In all these applications, different scientific groups have obtained convincing results in basic developments as well as in clinical use. Interventional MRI (iMRI) is expected to attain an important role in interventional radiology, minimal invasive therapy, and monitoring of surgical procedures.

Potential functional applications of extracellular vesicles: a report by the NIH Common Fund Extracellular RNA Communication Consortium

PubMed Central

Quesenberry, Peter J.; Aliotta, Jason; Camussi, Giovanni; Abdel-Mageed, Asim B.; Wen, Sicheng; Goldberg, Laura; Zhang, Huang-Ge; Tetta, Ciro; Franklin, Jeffrey; Coffey, Robert J.; Danielson, Kirsty; Subramanya, Vinita; Ghiran, Ionita; Das, Saumya; Chen, Clark C.; Pusic, Kae M.; Pusic, Aya D.; Chatterjee, Devasis; Kraig, Richard P.; Balaj, Leonora; Dooner, Mark

2015-01-01

The NIH Extracellular RNA Communication Program's initiative on clinical utility of extracellular RNAs and therapeutic agents and developing scalable technologies is reviewed here. Background information and details of the projects are presented. The work has focused on modulation of target cell fate by extracellular vesicles (EVs) and RNA. Work on plant-derived vesicles is of intense interest, and non-mammalian sources of vesicles may represent a very promising source for different therapeutic approaches. Retro-viral-like particles are intriguing. Clearly, EVs share pathways with the assembly machinery of several other viruses, including human endogenous retrovirals (HERVs), and this convergence may explain the observation of viral-like particles containing viral proteins and nucleic acid in EVs. Dramatic effect on regeneration of damaged bone marrow, renal, pulmonary and cardiovascular tissue is demonstrated and discussed. These studies show restoration of injured cell function and the importance of heterogeneity of different vesicle populations. The potential for neural regeneration is explored, and the capacity to promote and reverse neoplasia by EV exposure is described. The tremendous clinical potential of EVs underlies many of these projects, and the importance of regulatory issues and the necessity of general manufacturing production (GMP) studies for eventual clinical trials are emphasized. Clinical trials are already being pursued and should expand dramatically in the near future. PMID:26320942

The Importance of Factors Related to Nurse Retention: Using the Baptist Health Nurse Retention Questionnaire, Part 2.

PubMed

Bugajski, Andrew; Lengerich, Alex; Marchese, Matthew; Hall, Brittany; Yackzan, Susan; Davies, Claire; Brockopp, Dorothy

2017-06-01

The purpose of this study was to examine the importance of factors related to nurse retention. Retaining nurses within the healthcare system is a challenge for hospital administrators. Understanding factors important to nurse retention is essential. Responses of nurses (n = 279) to the Baptist Health Nurse Retention Questionnaire (BHNRQ) at a 391-bed Magnet® redesignated community hospital were analyzed to explore differences in importance scores of bedside nurses. The results demonstrate that each of the 12 items on the BHNRQ was moderately to highly important. A multivariate analysis of variance based on generation, degree, unit, and experience revealed no significant differences on subscale scores (nursing practice, management, and staffing). Themes derived from the comment section on the BHNRQ were consistent with quantitative findings. Clinical and managerial competence, engagement with their employees, and presence on the unit are keys to retaining a satisfied nursing workforce.

Evaluation of clinical pharmacy services offered for palliative care patients in Qatar.

PubMed

Wilby, Kyle John; Mohamad, Alaa Adil; AlYafei, Sumaya AlSaadi

2014-09-01

Palliative care is an emerging concept in the countries of the Gulf Cooperation Council, a political and economic union of Arab states bordering the Persian Gulf, namely Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. Clinical pharmacy services have not yet been evaluated in this region. The objectives of this study were to create a baseline inventory of clinical pharmacy interventions in palliative care and to assess the perceived importance of interventions made. This was a prospective, single-center characterization study. Interventions were documented from September 30 to December 1, 2013. They were characterized into predetermined categories and analyzed using descriptive statistics. Physician acceptance rate and intervention rate per patient were calculated. Classification categories were sent to 10 practicing pharmacists in each of Qatar and Canada, who ranked the categories on the basis of perceived importance. A total of 96 interventions were documented, giving 3 interventions per patient and an acceptance rate of 81%. Discontinuing therapy (29%), initiating therapy (25%), and provision of education/counseling (13.5%) were most common. No differences were found between rankings from pharmacists in Qatar or Canada. Clinical pharmacy interventions are frequent, and those relating to alterations in drug therapy are most common. Interventions align with the perceived importance from pharmacists in both Qatar and Canada.

South Asian patients' views and experiences of clinical trial participation.

PubMed

Hussain-Gambles, Mah

2004-12-01

This paper explores South Asian patients' views and experiences of clinical trial participation, as part of a larger study which sought to assess British South Asian under-representation in clinical trials. The study was based on semi-structured interviews with South Asian trial participants in primary care and specialist treatment centres in the north of England. Fifteen South Asian patients who had participated in one of six different clinical trials to test pharmaceutical products comprised the study cohort. South Asian motivations to participate in clinical trials are similar to those of the majority 'White' population. Clear and concise trial information (provided by caring and understanding trial staff) was considered an important aspect of the respondents' experiences. Appealing to South Asian peoples' altruistic nature by making them aware of South Asian under-representation (especially in clinical trials that investigate illnesses prevalent in their community) was also identified as a strong motivational factor. Potential barriers to their participation included: trial burden (which bears heavily on the poor), language, and discriminatory practices in the NHS, which can lead to mistrust of health professionals. In addition, female modesty and preference for female trial staff was recognized as a 'cultural' barrier to participation. There are more similarities than differences between the experiences of British South Asians and 'White' trial participants. Present findings suggest that ethnicity operates at different levels. In addition to South Asian trial participants' culture, social class and gender are also as likely to affect their participation in clinical trials. To improve South Asian accrual rates, strategies should be designed to take into consideration linguistic differences and improving overall trust in the clinical trial team.

Why is there variation in the practice of evidence-based medicine in primary care? A qualitative study

PubMed Central

Hisham, Ranita; Ng, Chirk Jenn; Liew, Su May; Hamzah, Nurazira; Ho, Gah Juan

2016-01-01

Objective To explore the factors, including barriers and facilitators, influencing the practice of evidence-based medicine (EBM) across various primary care settings in Malaysia based on the doctors’ views and experiences. Research design The qualitative study was used to answer the research question. 37 primary care physicians participated in six focus group discussions and six individual in-depth interviews. A semistructured topic guide was used to facilitate both the interviews and focus groups, which were audio recorded, transcribed verbatim, checked and analysed using a thematic approach. Participants 37 primary care doctors including medical officers, family medicine specialists, primary care lecturers and general practitioners with different working experiences and in different settings. Setting The study was conducted across three primary care settings—an academic primary care practice, private and public health clinics in Klang Valley, Malaysia. Results The doctors in this study were aware of the importance of EBM but seldom practised it. Three main factors influenced the implementation of EBM in the doctors’ daily practice. First, there was a lack of knowledge and skills in searching for and applying evidence. Second, workplace culture influenced doctors’ practice of EBM. Third, some doctors considered EBM as a threat to good clinical practice. They were concerned that rigid application of evidence compromised personalised patient care and felt that EBM did not consider the importance of clinical experience. Conclusions Despite being aware of and having a positive attitude towards EBM, doctors in this study seldom practised EBM in their routine clinical practice. Besides commonly cited barriers such as having a heavy workload and lack of training, workplace ‘EBM culture’ had an important influence on the doctors’ behaviour. Strategies targeting barriers at the practice level should be considered when implementing EBM in primary care. PMID:26962037

Comparative Effect of Contrast Media Type on the Incidence of Contrast-Induced Nephropathy: A Systematic Review and Meta-analysis.

PubMed

Eng, John; Wilson, Renee F; Subramaniam, Rathan M; Zhang, Allen; Suarez-Cuervo, Catalina; Turban, Sharon; Choi, Michael J; Sherrod, Cheryl; Hutfless, Susan; Iyoha, Emmanuel E; Bass, Eric B

2016-03-15

Iodine contrast media are essential components of many imaging procedures. An important potential side effect is contrast-induced nephropathy (CIN). To compare CIN risk for contrast media within and between osmolality classes in patients receiving diagnostic or therapeutic imaging procedures. PubMed, EMBASE, Cochrane Library, Clinical Trials.gov, and Scopus through June 2015. Randomized, controlled trials that reported CIN-related outcomes in patients receiving low-osmolar contrast media (LOCM) or iso-osmolar contrast media for imaging. Independent study selection and quality assessment by 2 reviewers and dual extraction of study characteristics and results. None of the 5 studies that compared types of LOCM reported a statistically significant or clinically important difference among study groups, but the strength of evidence was low. Twenty-five randomized, controlled trials found a slight reduction in CIN risk with the iso-osmolar contrast media agent iodixanol compared with a diverse group of LOCM that just reached statistical significance in a meta-analysis (pooled relative risk, 0.80 [95% CI, 0.65 to 0.99]; P = 0.045). This comparison's strength of evidence was moderate. In a meta regression of randomized, controlled trials of iodixanol, no relationship was found between route of administration and comparative CIN risk. Few studies compared LOCM. Procedural details about contrast administration were not uniformly reported. Few studies specified clinical indications or severity of baseline renal impairment. No differences were found in CIN risk among types of LOCM. Iodixanol had a slightly lower risk for CIN than LOCM, but the lower risk did not exceed a criterion for clinical importance. Agency for Healthcare Research and Quality.

Situational awareness - what it means for clinicians, its recognition and importance in patient safety.

PubMed

Green, B; Parry, D; Oeppen, R S; Plint, S; Dale, T; Brennan, P A

2017-09-01

A thorough understanding of the role of human factors in error in health care for improving patient safely is paramount. One area particularly crucial for optimising clinical performance is the recognising the importance of situational awareness. Loss of situation awareness can occur in many different settings, particularly during stressful and unexpected situations. Tunnel vision is a classic example where clinicians focus on one aspect of care, often to the detriment of overall patient management. Loss of situational awareness can result in serious compromise to patient safety if it is not recognised by either the individual or clinical team. We provide an introduction to situational awareness for those not familiar with it, including some important theory which explains how awareness can be lost, and discuss the important approaches we use in our day-to-day practice to safeguard both patients and clinicians in the workplace environment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Gender Differences in Treatment-Seeking British Pathological Gamblers

PubMed Central

Ronzitti, Silvia; Lutri, Vittorio; Smith, Neil; Clerici, Massimo; Bowden-Jones, Henrietta

2016-01-01

Background and aim Gambling is a widespread recreational activity in the UK. A significant percentage of gamblers develop subclinical or clinically relevant problem gambling issues, but only a low percentage of them seek treatment. Although characteristics of pathological gamblers from treatment-seeking population have been examined in some research, only a few studies have explored the differences between females and males. This study aimed to examine the gender-related differences in demographics, gambling measures, and clinical variables in an outpatient sample of pathological gamblers seeking treatment. Methods A total of 1,178 treatment-seeking individuals with gambling disorder were assessed at the National Problem Gambling Clinic in London. Sociodemographic characteristics, clinical variables, and gambling behavior habits were obtained during the assessment evaluation. Of the total sample, 92.5% were males and 7.5% were females. Results Males were more likely to be younger, white, and employed than females. In addition, compared to women, men showed a lower PGSI score, an earlier age of onset of gambling behavior, a higher gambling involvement, and preferred specific forms gambling. Female gamblers were more anxious and depressed, while men were more likely to use alcohol and illicit drugs. Conclusions Our findings support the importance of gender differences in a treatment-seeking population of pathological gamblers both in sociodemographic characteristics, gambling behavior variables, and clinical variables. Males and females might benefit from group-specific treatment. PMID:27348561

Outcome scores in spinal surgery quantified: excellent, good, fair and poor in terms of patient-completed tools.

PubMed

Tafazal, Suhayl I; Sell, Philip J

2006-11-01

Outcome scores are very useful tools in the field of spinal surgery as they allow us to assess a patient's progress and the effect of various treatments. The clinical importance of a score change is not so clear. Although previous studies have looked at the minimum clinically important score change, the degree of score change varies considerably. Our study is a prospective cohort study of 193 patients undergoing discectomy, decompression and fusion procedures with minimum 2-year follow-up. We have used three standard outcome measures in common usage, the oswestry disability index (ODI), the low back outcome score (LBOS) and the visual analogue score (VAS). We have defined each of these scores according to a global measure of outcome graded by the patient as excellent, good, fair or poor. We have also graded patient perception and classified excellent and good as success and fair and poor as failure. Our results suggest that a median 24-point change in the ODI equates with a good outcome or is the minimum change needed for success. We have also found that different surgical disorders have very different minimal clinically important differences as perceived by patient perception. We found that for a discectomy a minimum 27-point change in the ODI would be classed as a success, for a decompression the change in ODI needed to class it as a success would be 16 points, whereas for a fusion the change in the ODI would be only 13 points. We believe that patient-rated global measures of outcome are of value and we have quantified them in terms of the standard outcome measures used in spinal surgery.

Antiphospholipid antibodies and antiphospholipid syndrome in patients presenting with immune thrombocytopenic purpura: a prospective cohort study.

PubMed

Diz-Küçükkaya, R; Hacihanefioğlu, A; Yenerel, M; Turgut, M; Keskin, H; Nalçaci, M; Inanç, M

2001-09-15

The pathogenetic role and the clinical importance of the presence of antiphospholipid antibodies (APAs) in patients with immune thrombocytopenic purpura (ITP) are not clear. In this study, the prevalence and clinical significance of APAs were investigated in patients with ITP. Eighty-two newly diagnosed ITP patients were prospectively studied. They were evaluated for the presence of lupus anticoagulant (LA) and immunoglobulin G/M anticardiolipin antibodies (ACAs). Thirty-one patients (37.8%) were APA positive at diagnosis. No statistically significant differences were found between the APA-positive and APA-negative groups regarding gender, initial platelet counts, or response to methylprednisolone therapy. After 5 years of follow-up, cumulative thrombosis-free survival of APA-positive (n = 31) and APA-negative (n = 51) ITP patients was 39% and 97.7%, respectively. A significant difference was found between these groups by log-rank test (P =.0004). In addition, LA was an important risk marker for the development of thrombosis in ITP patients. After a median follow-up of 38 months, 14 ITP patients (45%) who had APA positivity developed clinical features (thrombosis or fetal losses) of antiphospholipid syndrome (APS). There were no differences between the APA-positive patients with and without APS regarding the initial platelet counts, response to the therapy, or ACA positivity. The positivity rate for LA was significantly higher in those patients with ITP who developed APS (chi(2): P =.0036; relative risk 7.15; 95% confidence interval, 1.7-47). In conclusion, this study indicates that a significant proportion of patients initially presenting with ITP and APA positivity developed APS. In patients with ITP, the persistent presence of APAs is an important risk factor for the development of APS.

Molecular approaches to epidemiology and clinical aspects of malaria.

PubMed

Brown, G V; Beck, H P; Molyneux, M; Marsh, K

2000-10-01

Malaria is a problem of global importance, responsible for 1-2 million deaths per year, mainly in African children, as well as considerable morbidity manifested as severe anaemia and encephalopathy in young children. Fundamental to the development of new tools for malaria control in humans is an increased understanding of key features of malaria infection, such as the diversity of outcome in different individuals, the understanding of different manifestations of the disease and of the mechanisms of immunity that allow clinical protection in the face of ongoing low-grade infection (concomitant immunity or premunition). Here, Graham Brown and colleagues review some of the ways in which molecular approaches might be used to increase our understanding of the epidemiology and clinical manifestations of malaria, as discussed at the Molecular Approaches to Malaria conference (MAM2000), Lorne, Australia, 2-5 February 2000.

Structure, Process, and Culture Differences of Pediatric Trauma Centers Participating in an International Comparative Effectiveness Study of Children with Severe Traumatic Brain Injury.

PubMed

Larsen, Gitte Y; Schober, Michelle; Fabio, Anthony; Wisniewski, Stephen R; Grant, Mary Jo C; Shafi, Nadeem; Bennett, Tellen D; Hirtz, Deborah; Bell, Michael J

2016-06-01

Traumatic brain injury (TBI) is an important worldwide cause of death and disability for children. The Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial is an observational, cohort study to compare the effectiveness of six aspects of TBI care. Understanding the differences between clinical sites-including their structure, clinical processes, and culture differences-will be necessary to assess differences in outcome from the study and can inform the overall community regarding differences across academic centers. We developed a survey and queried ADAPT site principal investigators with a focus on six domains: (i) hospital, (ii) pediatric intensive care unit (PICU), (iii) medical staff characteristics, (iv) quality of care, (v) medication safety, and (vi) safety culture. Summary statistics were used to describe differences between centers. ADAPT clinical sites that enrolled a subject within the first year (32 US-based, 11 international) were studied. A wide variation in site characteristics was observed in hospital and ICU characteristics, including an almost sevenfold range in ICU size (8-55 beds) and more than fivefold range of overall ICU admissions (537-2623). Nursing staffing (predominantly 1:1 or 1:2) and the presence of pharmacists within the ICU (79 %) were less variable, and most sites "strongly agreed" or "agreed" that Neurosurgery and Critical Care teams worked well together (81.4 %). However, a minority of sites (46 %) used an explicit protocol for treatment of children with severe TBI care. We found a variety of inter-center structure, process, and culture differences. These intrinsic differences between sites may begin to explain why interventional studies have failed to prove efficacy of experimental therapies. Understanding these differences may be an important factor in analyzing future ADAPT trial results and in determining best practices for pediatric severe TBI.

What do physicians tell laboratories when requesting tests? A multi-method examination of information supplied to the microbiology laboratory before and after the introduction of electronic ordering.

PubMed

Georgiou, Andrew; Prgomet, Mirela; Toouli, George; Callen, Joanne; Westbrook, Johanna

2011-09-01

The provision of relevant clinical information on pathology requests is an important part of facilitating appropriate laboratory utilization and accurate results interpretation and reporting. (1) To determine the quantity and importance of handwritten clinical information provided by physicians to the Microbiology Department of a hospital pathology service; and (2) to examine the impact of a Computerized Provider Order Entry (CPOE) system on the nature of clinical information communication to the laboratory. A multi-method and multi-stage investigation which included: (a) a retrospective audit of all handwritten Microbiology requests received over a 1-month period in the Microbiology Department of a large metropolitan teaching hospital; (b) the administration of a survey to laboratory professionals to investigate the impact of different clinical information on the processing and/or interpretation of tests; (c) an expert panel consisting of medical staff and senior scientists to assess the survey findings and their impact on pathology practice and patient care; and (d) a comparison of the provision and value of clinical information before CPOE, and across 3 years after its implementation. The audit of handwritten requests found that 43% (n=4215) contained patient-related clinical information. The laboratory survey showed that 97% (84/86) of the different types of clinical information provided for wound specimens and 86% (43/50) for stool specimens were shown to have an effect on the processing or interpretation of the specimens by one or more laboratory professionals. The evaluation of the impact of CPOE revealed a significant improvement in the provision of useful clinical information from 2005 to 2008, rising from 90.1% (n=749) to 99.8% (n=915) (p<.0001) for wound specimens and 34% (n=129) to 86% (n=422) (p<.0001) for stool specimens. This study showed that the CPOE system provided an integrated platform to access and exchange valuable patient-related information between physicians and the laboratory. These findings have important implications for helping to inform decisions about the design and structure of CPOE screens and what data entry fields should be designated or made voluntary. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Clinical Importance of Steps Taken per Day among Persons with Multiple Sclerosis

PubMed Central

Motl, Robert W.; Pilutti, Lara A.; Learmonth, Yvonne C.; Goldman, Myla D.; Brown, Ted

2013-01-01

Background The number of steps taken per day (steps/day) provides a reliable and valid outcome of free-living walking behavior in persons with multiple sclerosis (MS). Objective This study examined the clinical meaningfulness of steps/day using the minimal clinically important difference (MCID) value across stages representing the developing impact of MS. Methods This study was a secondary analysis of de-identified data from 15 investigations totaling 786 persons with MS and 157 healthy controls. All participants provided demographic information and wore an accelerometer or pedometer during the waking hours of a 7-day period. Those with MS further provided real-life, health, and clinical information and completed the Multiple Sclerosis Walking Scale-12 (MSWS-12) and Patient Determined Disease Steps (PDDS) scale. MCID estimates were based on regression analyses and analysis of variance for between group differences. Results The mean MCID from self-report scales that capture subtle changes in ambulation (1-point change in PDSS scores and 10-point change in MSWS-12 scores) was 779 steps/day (14% of mean score for MS sample); the mean MCID for clinical/health outcomes (MS type, duration, weight status) was 1,455 steps/day (26% of mean score for MS sample); real-life anchors (unemployment, divorce, assistive device use) resulted in a mean MCID of 2,580 steps/day (45% of mean score for MS sample); and the MCID for the cumulative impact of MS (MS vs. control) was 2,747 steps/day (48% of mean score for MS sample). Conclusion The change in motion sensor output of ∼800 steps/day appears to represent a lower-bound estimate of clinically meaningful change in free-living walking behavior in interventions of MS. PMID:24023843

Comparison of the Hologic Aptima HIV-1 Quant Dx Assay to the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 Test v2.0 for the quantification of HIV-1 RNA in plasma samples.

PubMed

Schønning, Kristian; Johansen, Kim; Landt, Bodil; Benfield, Thomas; Westh, Henrik

2017-07-01

HIV-RNA is the most important parameter for monitoring antiviral treatment in individuals infected with HIV-1. Knowledge of the performance of different tests for the quantification of HIV-1 RNA is therefore important for clinical care. To compare the analytical performance of the Aptima HIV-1 Quant Dx Assay (Aptima) and the COBAS Ampliprep/COBAS TaqMan HIV-1 Test v2.0 (CAPCTMv2) for the quantification of HIV-1 RNA in plasma samples. The performance of the two tests was compared on 216 clinical plasma samples, on dilutions series in seven replicates of five clinical samples of known subtype and on ten replicates of the Acrometrix High and Low Positive Control. Bland-Altman analysis of 130 samples that quantified in both tests did not show indications of gross mis-quantification of either test. A tendency of the Aptima assay to quantify higher at high viral load compared to the CAPCTMv2 was observed in Bland-Altman analysis, by Deming regression (Slope 1.13) and in dilution series of clinical samples. Precision evaluated using the Acrometrix Positive Controls was similar for the High Control (CV: 1.2% vs. 1.3%; Aptima assay vs. CAPCTMv2 test, respectively), but differed for the Low control (CV: 17.9% vs. 7.1%; Aptima assay vs. CAPCTMv2 test, respectively). However, this did not impact clinical categorization of clinical samples at neither the 50 cp/mL nor 200 cp/mL level. The Aptima assay and the CAPCTMv2 test are highly correlated and are useful for monitoring HIV-infected individuals. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of vedolizumab on health-related quality of life in patients with ulcerative colitis: results from the randomised GEMINI 1 trial.

PubMed

Feagan, B G; Patel, H; Colombel, J-F; Rubin, D T; James, A; Mody, R; Lasch, K

2017-01-01

Health-related quality of life (HRQL) is often diminished in patients with ulcerative colitis. To evaluate the effects of vedolizumab on HRQL in patients with ulcerative colitis. Using maintenance phase data from the GEMINI 1 study, an analysis of covariance model was used to calculate mean differences between the vedolizumab and placebo groups in changes from baseline to week 52 for 3 HRQL instruments: The Inflammatory Bowel Disease Questionnaire (IBDQ), 36-Item Short Form Health Survey (SF-36), and EQ-5D. Proportions of patients meeting minimal clinically important difference (MCID) thresholds for changes on these instruments were compared between treatment groups for the overall population and for clinically important subgroups. Concordance between clinical remission and remission defined using IBDQ scores was examined. Compared with placebo-treated patients, vedolizumab-treated patients had greater improvements (152-201%) in IBDQ, EQ-5D visual analogue scale (VAS), and EQ-5D utility scores. Greater proportions (6.9-19.9%) of vedolizumab-treated patients than placebo-treated patients met MCID thresholds for all the instruments. Vedolizumab-treated patients with lower baseline disease activity and those without prior tumour necrosis factor (TNF) antagonist failure had greater HRQL improvements. Among 127 patients with clinical remission based on complete Mayo Clinic scores, >80% also had IBDQ remission; >70% of the 150 patients with IBDQ remission demonstrated clinical remission. Vedolizumab therapy was associated with significant improvements in HRQL measures compared with placebo. Benefits were greater in patients with lower disease activity and no prior TNF antagonist failure. © 2016 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

Alternative Lipid Emulsions in the Critically Ill: A Systematic Review of the Evidence

PubMed Central

Manzanares, William; Dhaliwal, Rupinder; Jurewitsch, Brian; Stapleton, Renee D.; Jeejeebhoy, Khursheed N.; Heyland, Daren K.

2015-01-01

Introduction Parenteral lipid emulsions (LEs) are commonly rich in long-chain triglycerides (LCT) derived from soybean oil (SO). SO containing emulsions may promote systemic inflammation and therefore may adversely affect clinical outcomes. We hypothesized that alternative oil-based LEs (SO-sparing strategies) may improve clinical outcomes in critically ill adult patients compared to SO emulsion only products. The purpose of this systematic review was to evaluate the effect of parenteral SO-sparing strategies on clinical outcomes in intensive care unit (ICU) patients. Methods We searched computerized databases from 1980 to 2013. We included randomized controlled trials (RCTs) conducted in critically ill adult patients that evaluated SO-sparing strategies versus SO-based LEs in the context of parenteral nutrition (PN). Results A total of 12 RCTs met inclusion criteria. When the results of these RCTs that were statistically aggregated, SO-sparing strategies were associated with clinically important reductions in mortality (risk ratio RR= 0.83, 95% confidence intervals CI 0.62, 1.11, P = 0.20), in duration of ventilation (weighted mean difference, WMD −2.57, 95% CI −5.51, 0.37, P= 0.09), and in ICU length of stay (WMD −2.31, 95% CI −5.28, 0.66, P= 0.13) but none of these differences were statistically significant. SO-sparing strategies had no effect on infectious complications (RR=1.13, 95% CI 0.87, 1.46, P=0.35). Conclusion Alternative oil-based LEs may be associated with clinically important reductions in mortality, duration of ventilation, and ICU LOS but lack of statistical precision precludes any clinical recommendations at this time. Further research is warranted to confirm these potential positive treatment effects. PMID:23812404

Alternative lipid emulsions in the critically ill: a systematic review of the evidence.

PubMed

Manzanares, William; Dhaliwal, Rupinder; Jurewitsch, Brian; Stapleton, Renee D; Jeejeebhoy, Khursheed N; Heyland, Daren K

2013-10-01

Parenteral lipid emulsions (LEs) are commonly rich in long-chain triglycerides derived from soybean oil (SO). SO-containing emulsions may promote systemic inflammation and therefore may adversely affect clinical outcomes. We hypothesized that alternative oil-based LEs (SO-sparing strategies) may improve clinical outcomes in critically ill adult patients compared to products containing SO emulsion only. The purpose of this systematic review was to evaluate the effect of parenteral SO-sparing strategies on clinical outcomes in intensive care unit (ICU) patients. We searched computerized databases from 1980 to 2013. We included randomized controlled trials (RCTs) conducted in critically ill adult patients that evaluated SO-sparing strategies versus SO-based LEs in the context of parenteral nutrition. A total of 12 RCTs met the inclusion criteria. When the results of these RCTs were statistically aggregated, SO-sparing strategies were associated with clinically important reductions in mortality (risk ratio, RR 0.83; 95 % confidence intervals, CI 0.62, 1.11; P = 0.20), in duration of ventilation (weighted mean difference, WMD -2.57; 95 % CI -5.51, 0.37; P = 0.09), and in ICU length of stay (LOS) (WMD -2.31; 95 % CI -5.28, 0.66; P = 0.13) but none of these differences were statistically significant. SO-sparing strategies had no effect on infectious complications (RR 1.13; 95 % CI 0.87, 1.46; P = 0.35). Alternative oil-based LEs may be associated with clinically important reductions in mortality, duration of ventilation, and ICU LOS but lack of statistical precision precludes any clinical recommendations at this time. Further research is warranted to confirm these potential positive treatment effects.

The characteristics of a good clinical teacher as perceived by resident physicians in Japan: a qualitative study.

PubMed

Kikukawa, Makoto; Nabeta, Hiromi; Ono, Maiko; Emura, Sei; Oda, Yasutomo; Koizumi, Shunzo; Sakemi, Takanobu

2013-07-25

It is not known whether the characteristics of a good clinical teacher as perceived by resident physicians are the same in Western countries as in non-Western countries including Japan. The objective of this study was to identify the characteristics of a good clinical teacher as perceived by resident physicians in Japan, a non-Western country, and to compare the results with those obtained in Western countries. Data for this qualitative research were collected using semi-structured focus group interviews. Focus group transcripts were independently analyzed and coded by three authors. Residents were recruited by maximum variation sampling until thematic saturation was achieved. Twenty-three residents participated in five focus group interviews regarding the perceived characteristics of a good clinical teacher in Japan. The 197 descriptions of characteristics that were identified were grouped into 30 themes. The most commonly identified theme was "provided sufficient support", followed by "presented residents with chances to think", "provided feedback", and "provided specific indications of areas needing improvement". Using Sutkin's main categories (teacher, physician, and human characteristics), 24 of the 30 themes were categorized as teacher characteristics, 6 as physician characteristics, and none as human characteristics. "Medical knowledge" of teachers was not identified as a concern of residents, and "clinical competence of teachers" was not emphasized, whereas these were the two most commonly recorded themes in Sutkin's study. Our results suggest that Japanese and Western resident physicians place emphasis on different characteristics of their teachers. We speculate that such perceptions are influenced by educational systems, educational settings, and culture. Globalization of medical education is important, but it is also important to consider differences in educational systems, local settings, and culture when evaluating clinical teachers.

Antimicrobial Stewardship: How the Microbiology Laboratory Can Right the Ship

PubMed Central

Schwartz, David N.; Weinstein, Robert A.

2016-01-01

SUMMARY Antimicrobial stewardship is a bundle of integrated interventions employed to optimize the use of antimicrobials in health care settings. While infectious-disease-trained physicians, with clinical pharmacists, are considered the main leaders of antimicrobial stewardship programs, clinical microbiologists can play a key role in these programs. This review is intended to provide a comprehensive discussion of the different components of antimicrobial stewardship in which microbiology laboratories and clinical microbiologists can make significant contributions, including cumulative antimicrobial susceptibility reports, enhanced culture and susceptibility reports, guidance in the preanalytic phase, rapid diagnostic test availability, provider education, and alert and surveillance systems. In reviewing this material, we emphasize how the rapid, and especially the recent, evolution of clinical microbiology has reinforced the importance of clinical microbiologists' collaboration with antimicrobial stewardship programs. PMID:27974411

Comparative analyses of host responses upon infection with moderately virulent classical swine fever virus in domestic pigs and wild boar.

PubMed

Petrov, Anja; Blohm, Ulrike; Beer, Martin; Pietschmann, Jana; Blome, Sandra

2014-07-29

Classical swine fever (CSF) is one of the most important viral diseases of pigs. Clinical signs may vary from almost inapparent infection to a hemorrhagic fever like illness. Among the host factors leading to different disease courses are age, breed, and immune status. The aim of this study was to compare host responses of different pig breeds upon infection with a recent moderately virulent CSF virus (CSFV) strain, and to assess their impact on the clinical outcome and the efficiency of immune responses. To this means, two domestic pig types (German Landrace and hybrids), were compared to European wild boar. Along with clinical and pathological assessments and routine virological and serological methods, kinetics of immune-cellular parameters were evaluated. All animals were susceptible to infection and despite clinical differences, virus could be detected in all infected animals to similar amounts. All but one animal developed an acute disease course, two landrace animals recovered after a transient infection. One wild boar got chronically infected. Changes in the percentages of lymphocyte subsets in peripheral blood did not show a clear correlation with the clinical outcome. High and early titers of neutralizing antibodies were especially detected in wild boar and German Landrace pigs. While differences among breeds did not have the expected impact on course and outcome of CSFV infection, preload with facultative pathogens and even small differences in age seemed to be more relevant. Future studies will target the characterization of responses observed during different disease courses including cytokine reactions and further analyses of lymphocyte subsets.

Clinical results in cachexia therapeutics.

PubMed

Crawford, Jeffrey

2016-05-01

This article highlights recent developments in the area of cancer cachexia and therapeutic interventions. Therapeutic interventions in cancer cachexia have been guided by clinical studies focused on the central role of muscle and the increased use of CT imaging to measure the impact of skeletal muscle loss on clinical outcomes. At the translational level, a number of different model systems have emphasized the importance of blockade of tumor-induced inflammation and its potential impact on reversing the cachexia phenotype, including FN14, a receptor in the TNF pathway, as well as the parathyroid hormone-related protein. Clinical studies continue to demonstrate the importance of nutrition and exercise as part of a multimodality approach. Although a number of promising agents are being evaluated, both enobosarm, a selected androgen receptor modulator, and anamorelin, a ghrelin agonist have completed phase III trials. Both agents have shown significant impact on reversal of skeletal muscle loss, but inconsistent effect on physical function improvement. Anamorelin also has a positive effect on appetite and weight gain. Further analysis of these studies, along with regulatory guidance, will be critical in the further development of these and other promising agents in the clinical management of patients with cancer cachexia.

Nursing students' evaluation of quality indicators during learning in clinical practice.

PubMed

Jansson, Inger; Ene, Kerstin W

2016-09-01

A supportive clinical learning environment is important for nursing students' learning. In this study, a contract between a county and a university involving a preceptor model of clinical education for nursing students is described. The aim of this study was to describe nursing students' clinical education based on quality indicators and to describe the students' experiences of what facilitated or hindered the learning process during their clinical practice. During autumn 2012 and spring 2013, 269 student evaluations with quantitative and qualitative answers were filled out anonymously. Quantitative data from the questionnaires concerning the quality indicators: Administration/information, Assessments/examinations and Reflection were processed to generate descriptive statistics that revealed gaps in what the preceptor model demands and what the students reported. The answers from the qualitative questions concerning the quality indicator Learning were analysed using content analysis. Four categories emerged: Independence and responsibility, continuity of learning, time, and the competence and attitudes of the staff. The study underlines that reflection, continuity, communication and feedback were important for the students' learning process, whereas heavy workload among staff and being supervised by many different preceptors were experienced as stressful and hindering by students. Copyright © 2016 Elsevier Ltd. All rights reserved.

Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice.

PubMed

Kroenke, Kurt; Monahan, Patrick O; Kean, Jacob

2015-09-01

Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. Although psychometric rigor is essential, this article focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Three sources were drawn on in identifying pragmatic criteria for PROs: (1) selected literature review including recommendations by other expert groups; (2) key features of several model public domain PROs; and (3) the authors' experience in developing practical PROs. Eight characteristics of a practical PRO include: (1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision making); (2) appropriateness for the relevant clinical setting; (3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); (4) self-administration; (5) item features (number of items and bundling issues); (6) response options (option number and dimensions, uniform vs. varying options, time frame, intervals between options); (7) scoring (simplicity and interpretability); and (8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, and incorporated into electronic health records). Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. Published by Elsevier Inc.

Social Pharmacy and Clinical Pharmacy—Joining Forces

PubMed Central

Almarsdottir, Anna Birna; Granas, Anne Gerd

2015-01-01

This commentary seeks to define the areas of social pharmacy and clinical pharmacy to uncover what they have in common and what still sets them apart. Common threats and challenges of the two areas are reviewed in order to understand the forces in play. Forces that still keep clinical and social pharmacy apart are university structures, research traditions, and the management of pharmacy services. There are key (but shrinking) differences between clinical and social pharmacy which entail the levels of study within pharmaceutical sciences, the location in which the research is carried out, the choice of research designs and methods, and the theoretical foundations. Common strengths and opportunities are important to know in order to join forces. Finding common ground can be developed in two areas: participating together in multi-disciplinary research, and uniting in a dialogue with internal and external key players in putting forth what is needed for the profession of pharmacy. At the end the question is posed, “What’s in a name?” and we argue that it is important to emphasize what unifies the families of clinical pharmacy and social pharmacy for the benefit of both fields, pharmacy in general, and society at large. PMID:28970374

Social Pharmacy and Clinical Pharmacy-Joining Forces.

PubMed

Almarsdottir, Anna Birna; Granas, Anne Gerd

2015-12-22

This commentary seeks to define the areas of social pharmacy and clinical pharmacy to uncover what they have in common and what still sets them apart. Common threats and challenges of the two areas are reviewed in order to understand the forces in play. Forces that still keep clinical and social pharmacy apart are university structures, research traditions, and the management of pharmacy services. There are key (but shrinking) differences between clinical and social pharmacy which entail the levels of study within pharmaceutical sciences, the location in which the research is carried out, the choice of research designs and methods, and the theoretical foundations. Common strengths and opportunities are important to know in order to join forces. Finding common ground can be developed in two areas: participating together in multi-disciplinary research, and uniting in a dialogue with internal and external key players in putting forth what is needed for the profession of pharmacy. At the end the question is posed, "What's in a name?" and we argue that it is important to emphasize what unifies the families of clinical pharmacy and social pharmacy for the benefit of both fields, pharmacy in general, and society at large.

Quantitative evaluation of phonetograms in the case of functional dysphonia.

PubMed

Airainer, R; Klingholz, F

1993-06-01

According to the laryngeal clinical findings, figures making up a scale were assigned to vocally trained and vocally untrained persons suffering from different types of functional dysphonia. The different types of dysphonia--from the manifested hypofunctional to the extreme hyperfunctional dysphonia--were classified by means of this scale. Besides, the subjects' phonetograms were measured and approximated by three ellipses, what rendered possible the definition of phonetogram parameters. The combining of selected phonetogram parameters to linear combinations served the purpose of a phonetographic evaluation. The linear combinations were to bring phonetographic and clinical evaluations into correspondence as accurately as possible. It was necessary to use different kinds of linear combinations for male and female singers and nonsingers. As a result of the reclassification of 71 and the new classification of 89 patients, it was possible to graduate the types of functional dysphonia by means of computer-aided phonetogram evaluation with a clinically acceptable error rate. This method proved to be an important supplement to the conventional diagnostics of functional dysphonia.

A Systematic Review of the Anxiolytic-Like Effects of Essential Oils in Animal Models.

PubMed

de Sousa, Damião Pergentino; de Almeida Soares Hocayen, Palloma; Andrade, Luciana Nalone; Andreatini, Roberto

2015-10-14

The clinical efficacy of standardized essential oils (such as Lavender officinalis), in treating anxiety disorders strongly suggests that these natural products are an important candidate source for new anxiolytic drugs. A systematic review of essential oils, their bioactive constituents, and anxiolytic-like activity is conducted. The essential oil with the best profile is Lavendula angustifolia, which has already been tested in controlled clinical trials with positive results. Citrus aurantium using different routes of administration also showed significant effects in several animal models, and was corroborated by different research groups. Other promising essential oils are Citrus sinensis and bergamot oil, which showed certain clinical anxiolytic actions; along with Achillea wilhemsii, Alpinia zerumbet, Citrus aurantium, and Spiranthera odoratissima, which, like Lavendula angustifolia, appear to exert anxiolytic-like effects without GABA/benzodiazepine activity, thus differing in their mechanisms of action from the benzodiazepines. The anxiolytic activity of 25 compounds commonly found in essential oils is also discussed.

[Clinical ecomomics: a pleading for complementing the medical curriculum and specialty training].

PubMed

Porzsolt, F; Weiss, M; Hege-Scheuing, G; Fangerau, H

2010-11-01

Clinical economics requires an understanding of clinical relationships just like health economy requires an understanding of economic relationships. Hitherto we have ensured that economists can differentiate symptoms from diagnoses and diagnostics from screening at the interface between medicine and economy. However, we overlooked the fact that physicians should be able to understand the principles of marginal benefit and medical ethics, as well as the differences among efficacy, effectiveness, and benefit, to be able to make sound decisions. To make up for this neglected demand, we present our definition of clinical economics, identify the potential conflicts between medical professionalism and commercialized medicine, describe the importance - but also the limits - of scientific evidence, explain the difference between 'prioritization' and strict rationing, and attempt to justify the fact that the necessary changes in the provision of healthcare will probably only be achieved if we instill this new way of thinking in medical students during their medical education. Complementing the medical curriculum with clinical economics would achieve this goal. © Georg Thieme Verlag KG Stuttgart · New York.

Clinical-academic partnerships research: converting the rhetoric into reality.

PubMed

Happell, Brenda

2005-09-01

An increasing recognition of the importance of research-based practice to the nursing profession has led to a number of strategies designed to increase the utilization and conduct of nursing research. The transfer of nursing education from hospitals to universities occurred partly in response to the identified theory-practice gap. Subsequently, a significant investment in joint clinical-academic positions and clinical professorial positions has been made with the intention of bridging the gap between the tertiary sector and the clinical field. Anecdotal evidence suggests that neither strategy has achieved the desired degree of success. The available literature suggests that nurses do not tend to become involved in the conduct of research, nor do they readily utilise research findings in their practice. It is hypothesized in this paper that this reflects the strong cultural differences between the clinical and academic worlds in nursing. The aim of this paper is to discuss the impact of these cultural differences and describe specific principals that could contribute to significant cultural change and the bridging of the academic-clinician divide.

Cornea and anterior eye assessment with slit lamp biomicroscopy, specular microscopy, confocal microscopy, and ultrasound biomicroscopy

PubMed Central

Martin, Raul

2018-01-01

Current corneal assessment technologies make the process of corneal evaluation extremely fast and simple, and several devices and technologies show signs that help in identification of different diseases thereby, helping in diagnosis, management, and follow-up of patients. The purpose of this review is to present and update readers on the evaluation of cornea and ocular surface. This first part reviews a description of slit lamp biomicroscopy (SLB), endothelial specular microscopy, confocal microscopy, and ultrasound biomicroscopy examination techniques and the second part describes the corneal topography and tomography, providing up-to-date information on the clinical recommendations of these techniques in eye care practice. Although the SLB is a traditional technique, it is of paramount importance in clinical diagnosis and compulsory when an eye test is conducted in primary or specialist eye care practice. Different techniques allow the early diagnosis of many diseases, especially when clinical signs have not yet become apparent and visible with SLB. These techniques also allow for patient follow-up in several clinical conditions or diseases, facilitating clinical decisions and improving knowledge regarding the corneal anatomy. PMID:29380757

Limits to the Evaluation of the Accuracy of Continuous Glucose Monitoring Systems by Clinical Trials.

PubMed

Schrangl, Patrick; Reiterer, Florian; Heinemann, Lutz; Freckmann, Guido; Del Re, Luigi

2018-05-18

Systems for continuous glucose monitoring (CGM) are evolving quickly, and the data obtained are expected to become the basis for clinical decisions for many patients with diabetes in the near future. However, this requires that their analytical accuracy is sufficient. This accuracy is usually determined with clinical studies by comparing the data obtained by the given CGM system with blood glucose (BG) point measurements made with a so-called reference method. The latter is assumed to indicate the correct value of the target quantity. Unfortunately, due to the nature of the clinical trials and the approach used, such a comparison is subject to several effects which may lead to misleading results. While some reasons for the differences between the values obtained with CGM and BG point measurements are relatively well-known (e.g., measurement in different body compartments), others related to the clinical study protocols are less visible, but also quite important. In this review, we present a general picture of the topic as well as tools which allow to correct or at least to estimate the uncertainty of measures of CGM system performance.

Mixed infections in tuberculosis: The missing part in a puzzle.

PubMed

Tarashi, Samira; Fateh, Abolfazl; Mirsaeidi, Mehdi; Siadat, Seyed Davar; Vaziri, Farzam

2017-12-01

The mixed strains infection phenomenon is a major problem posing serious challenges in control of tuberculosis (TB). In patients with mixed infection, several different strains of Mycobacterium tuberculosis can be isolated simultaneously. Although different genotyping methods and various molecular approaches can be employed for detection of mixed infection in clinical samples, the MIRU-VNTR technique is more sensitive with higher discriminative power than many widely used techniques. Furthermore, the recent introduction of whole genome sequencing (WGS) promises to reveal more details about mixed infection with high resolution. WGS has been used for detection of mixed infection with high sensitivity and discriminatory, but the technology is currently limited to developed countries. Mixed infection may involve strains with different susceptibility patterns, which may alter the treatment outcome. In this report, we review the current concepts of mixed strains infection and also infection involving strains with a different susceptibility pattern in TB. We evaluate the importance of identifying mixed infection for diagnosis as well as treatment and highlight the accuracy and clinical utility of direct genotyping of clinical specimens. Copyright © 2017 Elsevier Ltd. All rights reserved.

Population-based differences in treatment outcome following anticancer drug therapies.

PubMed

Ma, Brigette By; Hui, Edwin P; Mok, Tony Sk

2010-01-01

Population-based differences in toxicity and clinical outcome following treatment with anticancer drugs have an important effect on oncology practice and drug development. These differences arise from complex interactions between biological and environmental factors, which include genetic diversity affecting drug metabolism and the expression of drug targets, variations in tumour biology and host physiology, socioeconomic disparities, and regional preferences in treatment standards. Some well-known examples include the high prevalence of activating epidermal growth factor receptor (EGFR) mutations in pulmonary adenocarcinoma among northeast (China, Japan, Korea) and parts of southeast Asia (excluding India) non-smokers, which predict sensitivity to EGFR kinase inhibitors, and the sharp contrast between Japan and the west in the management and survival outcome of gastric cancer. This review is a critical overview of population-based differences in the four most prevalent cancers in the world: lung, breast, colorectal, and stomach cancer. Particular attention is given to the clinical relevance of such knowledge in terms of the individualisation of drug therapy and in the design of clinical trials. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Pharmacogenetics of tyrosine kinase inhibitors in gastrointestinal stromal tumor and chronic myeloid leukemia.

PubMed

Ravegnini, Gloria; Sammarini, Giulia; Angelini, Sabrina; Hrelia, Patrizia

2016-07-01

Gastrointestinal stromal tumors (GIST) and chronic myeloid leukemia (CML) are two tumor types deeply different from each other. Despite the differences, these disorders share treatment with tyrosine kinase inhibitor imatinib. Despite the success of imatinib, the response rates vary among different individuals and pharmacogenetics may play an important role in the final clinical outcome. In this review, the authors provide an overview of the pharmacogenetic literature analyzing the role of polymorphisms in both GIST and CML treatment efficacy and toxicity. So far, several polymorphisms influencing the pharmacokinetic determinants of imatinib have been identified. However, the data are not yet conclusive enough to translate pharmacogenetic tests in clinical practice. In this context, the major obstacles to pharmacogenetic test validation are represented by the small sample size of most studies, ethnicity and population admixture as confounding source, and uncertainty related to genetic variants analyzed. In conclusion, a combination of different theoretical approaches, experimental model systems and statistical methods is clearly needed, in order to appreciate pharmacogenetics applied to clinical practice in the near future.

Genotype and phenotype in patients with Prader-Willi syndrome in Taiwan.

PubMed

Lin, Hsiang-Yu; Lin, Shuan-Pei; Chuang, Chih-Kuang; Chen, Ming-Ren; Yen, Jui-Lung; Lee, Yann-Jinn; Huang, Chi-Yu; Tsai, Li-Ping; Niu, Dau-Ming; Chao, Mei-Chyn; Kuo, Pao-Lin

2007-06-01

Several different genetic defects have been found to result in the characteristic phenotypic expression of Prader-Willi syndrome (PWS). We performed a retrospective analysis of 67 cases of molecularly confirmed PWS diagnosed from January 1980 through July 2006 in five medical centres in Taiwan. Clinical manifestations were compared between patients with deletion and those with maternal uniparental disomy (UPD). Deletion was present in 56 (84%), UPD in 10 (15%), and a probable imprinting centre deletion or imprinting defect in 1 (1%). PWS with deletion was more likely than that with UPD to be characterized by hypogonadism (p < 0.001), small hands and feet (p < 0.001), and hypopigmentation (p < 0.002). Both maternal (p = 0.015) and paternal age (p = 0.021) were higher in the UPD group. No other clinical features differed significantly different between the two groups. In contrast to most Western populations with a higher incidence of UPD, this study of PWS in Taiwan shows a higher incidence of deletion. There may be subtle phenotypic differences between the UPD and deletion genotypes, but its not clear that these are important clinically.

Pre-registration nursing student's quality of practice learning: Clinical learning environment inventory (actual) questionnaire.

PubMed

Shivers, Eleanor; Hasson, Felicity; Slater, Paul

2017-08-01

Clinical learning is a vital component of nurse education and assessing student's experiences can provide useful insights for development. Whilst most research in this area has focused on the acute setting little attention has been given to all pre-registration nurses' experience across the clinical placements arenas. To examine of pre-registration nursing students (first, second and third year) assessment of their actual experiences of their most recent clinical learning clinical learning experience. A cross sectional survey involving a descriptive online anonymous questionnaire based on the clinical learning environment inventory tool. One higher education institution in the United Kingdom. Nursing students (n=147) enrolled in an undergraduate nursing degree. This questionnaire included demographic questions and the Clinical Learning Environment Inventory (CLEI) a 42 item tool measuring student's satisfaction with clinical placement. SPPS version 22 was employed to analyse data with descriptive and inferential statistics. Overall students were satisfied with their clinical learning experience across all placement areas. This was linked to the 6 constructs of the clinical learning environment inventory; personalization, innovation, individualization, task orientation, involvement, satisfaction. Significant differences in student experience were noted between age groups and student year but there was no difference noted between placement type, age and gender. Nursing students had a positive perception of their clinical learning experience, although there remains room for improvement. Enabling a greater understanding of students' perspective on the quality of clinical education is important for nursing education and future research. Copyright © 2017. Published by Elsevier Ltd.

Application of Hyphenated Techniques in Speciation Analysis of Arsenic, Antimony, and Thallium

PubMed Central

Michalski, Rajmund; Szopa, Sebastian; Jabłońska, Magdalena; Łyko, Aleksandra

2012-01-01

Due to the fact that metals and metalloids have a strong impact on the environment, the methods of their determination and speciation have received special attention in recent years. Arsenic, antimony, and thallium are important examples of such toxic elements. Their speciation is especially important in the environmental and biomedical fields because of their toxicity, bioavailability, and reactivity. Recently, speciation analytics has been playing a unique role in the studies of biogeochemical cycles of chemical compounds, determination of toxicity and ecotoxicity of selected elements, quality control of food products, control of medicines and pharmaceutical products, technological process control, research on the impact of technological installation on the environment, examination of occupational exposure, and clinical analysis. Conventional methods are usually labor intensive, time consuming, and susceptible to interferences. The hyphenated techniques, in which separation method is coupled with multidimensional detectors, have become useful alternatives. The main advantages of those techniques consist in extremely low detection and quantification limits, insignificant interference, influence as well as high precision and repeatability of the determinations. In view of their importance, the present work overviews and discusses different hyphenated techniques used for arsenic, antimony, and thallium species analysis, in different clinical, environmental and food matrices. PMID:22654649

Poster — Thur Eve — 72: Clinical Subtleties of Flattening-Filter-Free Beams

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

Corns, Robert; Thomas, Steven; Huang, Vicky

2014-08-15

Flattening-filter-free (fff) beams offer superior dose rates, reducing treatment times for important techniques that utilize small field sizes, such as stereotactic ablative radiotherapy (SABR). The impact of ion collection efficiency (P{sub ion}) on the percent depth dose (PDD) has been discussed at length in the literature. Relative corrections of the order of l%–2% are possible. In the process of commissioning 6fff and 10fff beams, we identified a number of other important details that influence commissioning. We looked at the absolute dose difference between corrected and uncorrected PDD. We discovered a curve with a broad maximum between 10 and 20 cm.more » We wondered about the consequences of this PDD correction on the absolute dose calibration of the linac because the TG-51 protocol does not correct the PDD curve. The quality factor k{sub Q} depends on the PDD, so in principle, a correction to the PDD will alter the absolute calibration of the linac. Finally, there are other clinical tables, such as TMR, which are derived from PDD. Attention to details on how this computation is performed is important because different corrections are possible depending the method of calculation.« less

GMP-compliant human adipose tissue-derived mesenchymal stem cells for cellular therapy.

PubMed

Aghayan, Hamid-Reza; Goodarzi, Parisa; Arjmand, Babak

2015-01-01

Stem cells, which can be derived from different sources, demonstrate promising therapeutic evidences for cellular therapies. Among various types of stem cell, mesenchymal stem cells are one of the most common stem cells that are used in cellular therapy. Human subcutaneous adipose tissue provides an easy accessible source of mesenchymal stem cells with some considerable advantages. Accordingly, various preclinical and clinical investigations have shown enormous potential of adipose-derived stromal cells in regenerative medicine. Consequently, increasing clinical applications of these cells has elucidated the importance of safety concerns regarding clinical transplantation. Therefore, clinical-grade preparation of adipose-derived stromal cells in accordance with current good manufacturing practice guidelines is an essential part of their clinical applications to ensure the safety, quality, characteristics, and identity of cell products. Additionally, GMP-compliant cell manufacturing involves several issues to provide a quality assurance system during translation from the basic stem cell sciences into clinical investigations and applications. On the other hand, advanced cellular therapy requires extensive validation, process control, and documentation. It also evidently elucidates the critical importance of production methods and probable risks. Therefore, implementation of a quality management and assurance system in accordance with GMP guidelines can greatly reduce these risks particularly in the higher-risk category or "more than minimally manipulated" products.

Experimental Approaches to Microarray Analysis of Tumor Samples

ERIC Educational Resources Information Center

Furge, Laura Lowe; Winter, Michael B.; Meyers, Jacob I.; Furge, Kyle A.

2008-01-01

Comprehensive measurement of gene expression using high-density nucleic acid arrays (i.e. microarrays) has become an important tool for investigating the molecular differences in clinical and research samples. Consequently, inclusion of discussion in biochemistry, molecular biology, or other appropriate courses of microarray technologies has…

Assessing Speech Discrimination in Individual Infants

ERIC Educational Resources Information Center

Houston, Derek M.; Horn, David L.; Qi, Rong; Ting, Jonathan Y.; Gao, Sujuan

2007-01-01

Assessing speech discrimination skills in individual infants from clinical populations (e.g., infants with hearing impairment) has important diagnostic value. However, most infant speech discrimination paradigms have been designed to test group effects rather than individual differences. Other procedures suffer from high attrition rates. In this…

Analysis of Forensic Autopsy in 120 Cases of Medical Disputes Among Different Levels of Institutional Settings.

PubMed

Yu, Lin-Sheng; Ye, Guang-Hua; Fan, Yan-Yan; Li, Xing-Biao; Feng, Xiang-Ping; Han, Jun-Ge; Lin, Ke-Zhi; Deng, Miao-Wu; Li, Feng

2015-09-01

Despite advances in medical science, the causes of death can sometimes only be determined by pathologists after a complete autopsy. Few studies have investigated the importance of forensic autopsy in medically disputed cases among different levels of institutional settings. Our study aimed to analyze forensic autopsy in 120 cases of medical disputes among five levels of institutional settings between 2001 and 2012 in Wenzhou, China. The results showed an overall concordance rate of 55%. Of the 39% of clinically missed diagnosis, cardiovascular pathology comprises 55.32%, while respiratory pathology accounts for the remaining 44. 68%. Factors that increase the likelihood of missed diagnoses were private clinics, community settings, and county hospitals. These results support that autopsy remains an important tool in establishing causes of death in medically disputed case, which may directly determine or exclude the fault of medical care and therefore in helping in resolving these cases. © 2015 American Academy of Forensic Sciences.

Measurement of Reactive Oxygen Species, Reactive Nitrogen Species, and Redox-Dependent Signaling in the Cardiovascular System

PubMed Central

Griendling, Kathy K.; Touyz, Rhian M.; Zweier, Jay L.; Dikalov, Sergey; Chilian, William; Chen, Yeong-Renn; Harrison, David G.; Bhatnagar, Aruni

2017-01-01

Reactive oxygen species and reactive nitrogen species are biological molecules that play important roles in cardiovascular physiology and contribute to disease initiation, progression, and severity. Because of their ephemeral nature and rapid reactivity, these species are difficult to measure directly with high accuracy and precision. In this statement, we review current methods for measuring these species and the secondary products they generate and suggest approaches for measuring redox status, oxidative stress, and the production of individual reactive oxygen and nitrogen species. We discuss the strengths and limitations of different methods and the relative specificity and suitability of these methods for measuring the concentrations of reactive oxygen and reactive nitrogen species in cells, tissues, and biological fluids. We provide specific guidelines, through expert opinion, for choosing reliable and reproducible assays for different experimental and clinical situations. These guidelines are intended to help investigators and clinical researchers avoid experimental error and ensure high-quality measurements of these important biological species. PMID:27418630

Biosimilars in inflammatory bowel disease: A review of post-marketing experience.

PubMed

Deiana, Simona; Gabbani, Tommaso; Annese, Vito

2017-01-14

Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug whose license has expired. Biosimilar drugs usually are marketed at a lower price and provide important financial savings for public healthcare systems. Some differences between biosimilars and original biologic drugs might exist but they are acceptable if they fall within defined "boundaries of tolerance": differences in some features between the two molecules are considered important only if clinical relevant. Considering that the efficacy of the innovator biologic drug has already been established, the clinical studies required for approval of a biosimilar could be reduced compared with those required for the approval of the originator. In this review, real life data available in inflammatory bowel disease patients treated with biosimilars are reported, documenting in general satisfactory outcomes, sustained efficacy and no sign of increased immunogenicity, although, further controlled data are awaited.

Crowdsourcing in biomedicine: challenges and opportunities.

PubMed

Khare, Ritu; Good, Benjamin M; Leaman, Robert; Su, Andrew I; Lu, Zhiyong

2016-01-01

The use of crowdsourcing to solve important but complex problems in biomedical and clinical sciences is growing and encompasses a wide variety of approaches. The crowd is diverse and includes online marketplace workers, health information seekers, science enthusiasts and domain experts. In this article, we review and highlight recent studies that use crowdsourcing to advance biomedicine. We classify these studies into two broad categories: (i) mining big data generated from a crowd (e.g. search logs) and (ii) active crowdsourcing via specific technical platforms, e.g. labor markets, wikis, scientific games and community challenges. Through describing each study in detail, we demonstrate the applicability of different methods in a variety of domains in biomedical research, including genomics, biocuration and clinical research. Furthermore, we discuss and highlight the strengths and limitations of different crowdsourcing platforms. Finally, we identify important emerging trends, opportunities and remaining challenges for future crowdsourcing research in biomedicine. Published by Oxford University Press 2015. This work is written by US Government employees and is in the public domain in the US.

Low-intensity laser therapy to treat dentin hypersensitivity: comparative clinical study using different light doses

NASA Astrophysics Data System (ADS)

Lizarelli, Rosane F. Z.; Mazzetto, Marcello O.; Bagnato, Vanderlei S.

2001-04-01

Dentin hypersensitivity is the most common patient's complain related to pain. In fact, this is a challenge to treat specially if conventional techniques are used. The possibility to treat pain through a low intensity laser gives us an opportunity to solve this important clinical problem without promote a discomfort to patient. The main point here is not if this kind of treatment is anti- inflammatory to pulp and/or biostimulatory to production of irregular secondary dentin. The most important point here is to understand how much energy is necessary to reach conditions where to tooth become insensible to external stimulus. Our double-blinded study compared a group without laser (Placebo) with five other groups where different doses at 660 nm low intensity laser were employed. The final conclusion is that for 660 nm laser therapy, the doses from 0.13 to 2.0 J/cm2 were more efficiency than the others. The follow up care in this study was of 45 days.

A novel mitochondrial DNA deletion in a patient with Pearson syndrome and neonatal diabetes mellitus provides insight into disease etiology, severity and progression.

PubMed

Chen, Xin-Yu; Zhao, Si-Yu; Wang, Yan; Wang, Dong; Dong, Chang-Hu; Yang, Ying; Wang, Zhi-Hua; Wu, Yuan-Ming

2016-07-01

Pearson syndrome (PS) is a rare, mitochondrial DNA (mtDNA) deletion disorder mainly affecting hematopoietic system and exocrine pancreas in early infancy, which is characterized by multi-organ involvement, variable manifestations and poor prognosis. Since the clinical complexity and uncertain outcome of PS, the ability to early diagnose and anticipate disease progression is of great clinical importance. We described a patient with severe anemia and hyperglycinemia at birth was diagnosed with neonatal diabetes mellitus, and later with PS. Genetic testing revealed that a novel mtDNA deletion existed in various non-invasive tissues from the patient. The disease course was monitored by mtDNA deletion heteroplasmy and mtDNA/nucleus DNA genome ratio in different tissues and at different time points, showing a potential genotype-phenotype correlation. Our findings suggest that for patient suspected for PS, it may be therapeutically important to first perform detailed mtDNA analysis on non-invasive tissues at the initial diagnosis and during disease progression.

Three-dimensional multispectral hand-held optoacoustic imaging with microsecond-level delayed laser pulses

NASA Astrophysics Data System (ADS)

Deán-Ben, X. L.; Bay, Erwin; Razansky, Daniel

2015-03-01

Three-dimensional hand-held optoacoustic imaging comes with important advantages that prompt the clinical translation of this modality, with applications envisioned in cardiovascular and peripheral vascular disease, disorders of the lymphatic system, breast cancer, arthritis or inflammation. Of particular importance is the multispectral acquisition of data by exciting the tissue at several wavelengths, which enables functional imaging applications. However, multispectral imaging of entire three-dimensional regions is significantly challenged by motion artefacts in concurrent acquisitions at different wavelengths. A method based on acquisition of volumetric datasets having a microsecond-level delay between pulses at different wavelengths is described in this work. This method can avoid image artefacts imposed by a scanning velocity greater than 2 m/s, thus, does not only facilitate imaging influenced by respiratory, cardiac or other intrinsic fast movements in living tissues, but can achieve artifact-free imaging in the presence of more significant motion, e.g., abrupt displacements during handheld-mode operation in a clinical environment.

Clinical diabetes research using data mining: a Canadian perspective.

PubMed

Shah, Baiju R; Lipscombe, Lorraine L

2015-06-01

With the advent of the digitization of large amounts of information and the computer power capable of analyzing this volume of information, data mining is increasingly being applied to medical research. Datasets created for administration of the healthcare system provide a wealth of information from different healthcare sectors, and Canadian provinces' single-payer universal healthcare systems mean that data are more comprehensive and complete in this country than in many other jurisdictions. The increasing ability to also link clinical information, such as electronic medical records, laboratory test results and disease registries, has broadened the types of data available for analysis. Data-mining methods have been used in many different areas of diabetes clinical research, including classic epidemiology, effectiveness research, population health and health services research. Although methodologic challenges and privacy concerns remain important barriers to using these techniques, data mining remains a powerful tool for clinical research. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

Parenting clinically anxious versus healthy control children aged 4-12 years.

PubMed

van der Sluis, C M; van Steensel, F J A; Bögels, S M

2015-05-01

This study investigated whether parenting behaviors differed between parents of 68 clinically anxious children and 106 healthy control children aged 4-12 years. The effects of parent gender, child gender and child age on parenting were explored. Mothers and fathers completed a questionnaire to assess parenting behaviors in for children hypothetically anxious situations. Results showed that parents of clinically anxious children reported more anxiety-enhancing parenting (reinforcement of dependency and punishment) as well as more positive parenting (positive reinforcement). For the clinical sample, fathers reported using more modeling/reassurance than mothers, and parents reported using more force with their 4-7-year-olds than with their 8-12-year-olds. No interaction effects were found for child gender with child anxiety status on parenting. Results indicate that for intervention, it is important to measure parenting behaviors, and to take into account father and mother differences and the age of the child. Copyright © 2015 Elsevier Ltd. All rights reserved.

Histoid leprosy: review of the literature.

PubMed

Gupta, Sunil Kumar

2015-11-01

Leprosy is a chronic granulomatous inflammation primarily of the peripheral nervous system, skin, and reticuloendothelial system caused by Mycobacterium leprae. It presents clinically as an erythematous or hypopigmented anesthetic patch and a thickened and/or tender cutaneous nerve trunk. Leprosy is also called Hansen disease. Leprosy is a great imitator of other skin diseases, and it can present with different morphological lesions, which is why an expert eye is needed to diagnose it. One of the important clinical presentations of leprosy is histoid leprosy, which is very difficult to diagnose due to different clinical and histopathological findings that mimic, e.g., a fibromatous disorder. Histoid leprosy is a very rare clinicopathological variant of leprosy. It is clinically characterized by skin-colored, soft, succulent nodules, and plaques on apparently normal skin and histologically by a dense bundle of histiocytes arranged in storiform. Though histoid leprosy is a very rare type of leprosy, the higher load of lepra bacilli in these cases makes it a concern as a reservoir for leprosy. © 2015 The International Society of Dermatology.

CMedTEX: A Rule-based Temporal Expression Extraction and Normalization System for Chinese Clinical Notes.

PubMed

Liu, Zengjian; Tang, Buzhou; Wang, Xiaolong; Chen, Qingcai; Li, Haodi; Bu, Junzhao; Jiang, Jingzhi; Deng, Qiwen; Zhu, Suisong

2016-01-01

Time is an important aspect of information and is very useful for information utilization. The goal of this study was to analyze the challenges of temporal expression (TE) extraction and normalization in Chinese clinical notes by assessing the performance of a rule-based system developed by us on a manually annotated corpus (including 1,778 clinical notes of 281 hospitalized patients). In order to develop system conveniently, we divided TEs into three categories: direct, indirect and uncertain TEs, and designed different rules for each category of them. Evaluation on the independent test set shows that our system achieves an F-score of93.40% on TE extraction, and an accuracy of 92.58% on TE normalization under "exact-match" criterion. Compared with HeidelTime for Chinese newswire text, our system is much better, indicating that it is necessary to develop a specific TE extraction and normalization system for Chinese clinical notes because of domain difference.

Testing the diagnosis of dissociative identity disorder through measures of dissociation, absorption, hypnotizability and PTSD: a Norwegian pilot study.

PubMed

Dale, Karl Yngvar; Berg, Renate; Elden, Ake; Ødegård, Atle; Holte, Arne

2009-01-01

A total of 14 women meeting criteria for dissociative identity disorder (DID) based on the Diagnostic and Statistical Manual of Mental Disorders (4th ed. [DSM-IV]) were compared to a group of women (n = 10) with other dissociative diagnoses and a group of normal controls (n = 14) with regard to dissociativity, absorption, trauma related symptoms and hypnotizability. Both of the clinical groups reported histories of childhood trauma and attained high PTSD scores. The DID group differed significantly from the group with other dissociative diagnoses and the non-diagnosed comparison group with regard to hypnotizability, the variety of dissociative symptomatology, and the magnitude of dissociative symptomatology. However, no significant differences between the two clinical groups were detected with regard to absorption, general dissociative level, or symptoms related to traumatic stress. Results support the notion that DID can be regarded as a clinical entity which is separable from other dissociative disorders. Results also indicated that hypnotizability is the most important clinical feature of DID.

Optimizing the early phase development of new analgesics by human pain biomarkers.

PubMed

Arendt-Nielsen, Lars; Hoeck, Hans Christian

2011-11-01

Human pain biomarkers are based on standardized acute activation of pain pathways/mechanisms and quantitative assessment of the evoked responses. This approach can be applied to healthy volunteers, to pain patients, and before and after pharmacological interventions to help understanding and profile the mode of action (proof-of-concept) of new and existing analgesic compounds. Standardized stimuli of different modalities can be applied to different tissues (multimodal and multi-tissue) for profiling analgesic compounds with respect to modulation of pain transduction, transmission, specific mechanisms and processing. This approach substantiates which specific compounds may work in particular clinical pain conditions. Human pain biomarkers can be translational and may bridge animal findings in clinical pain conditions, which in turn can provide new possibilities for designing more successful clinical trials. Biomarker based proof-of-concept drug studies in either volunteers or selected patient populations provide inexpensive, fast and reliable mechanism-based information about dose-efficacy relationships. This is important information in the early drug development phase and for designing large expensive clinical trials.

Potential and problems in ultrasound-responsive drug delivery systems

PubMed Central

Zhao, Ying-Zheng; Du, Li-Na; Lu, Cui-Tao; Jin, Yi-Guang; Ge, Shu-Ping

2013-01-01

Ultrasound is an important local stimulus for triggering drug release at the target tissue. Ultrasound-responsive drug delivery systems (URDDS) have become an important research focus in targeted therapy. URDDS include many different formulations, such as microbubbles, nanobubbles, nanodroplets, liposomes, emulsions, and micelles. Drugs that can be loaded into URDDS include small molecules, biomacromolecules, and inorganic substances. Fields of clinical application include anticancer therapy, treatment of ischemic myocardium, induction of an immune response, cartilage tissue engineering, transdermal drug delivery, treatment of Huntington’s disease, thrombolysis, and disruption of the blood–brain barrier. This review focuses on recent advances in URDDS, and discusses their formulations, clinical application, and problems, as well as a perspective on their potential use in the future. PMID:23637531

Respiratory neuroplasticity - Overview, significance and future directions.

PubMed

Fuller, David D; Mitchell, Gordon S

2017-01-01

Neuroplasticity is an important property of the neural system controlling breathing. However, our appreciation for its importance is still relatively new, and we have much to learn concerning different forms of plasticity, their underlying mechanisms, and their biological and clinical significance. In this brief review, we discuss several well-studied models of respiratory plasticity, including plasticity initiated by inactivity in the respiratory system, intermittent and sustained hypoxia, and traumatic injury to the spinal cord. Other aspects of respiratory plasticity are considered in other contributions to this special edition of Experimental Neurology on respiratory plasticity. Finally, we conclude with discussions concerning the biological and clinical significance of respiratory motor plasticity, and areas in need of future research effort. Copyright © 2016. Published by Elsevier Inc.

A multilevel analysis of factors affecting the difference in dental patients' and caregivers' evaluation of oral quality of life.

PubMed

Sampogna, F; Johansson, V; Axtelius, B; Abeni, D; Söderfeldt, B

2008-12-01

In a previous study, we observed that the concordance between patients' and caregivers' evaluation of oral health-related quality of life (OHRQoL) was low. The aim of this study was to use multilevel analysis to investigate the possible determinants of the low concordance, taking into account different patients' demographic and clinical variables, the financial system used by patients to pay for dental treatment, and the role of the different caregivers and clinics. The OHRQoL of patients was assessed both by the patients and by their caregivers, using the Oral Health Impact Profile (OHIP)-14. Data were collected in four clinics, and patients were evaluated by one of 27 caregivers. We tested eight multilevel models, using the difference (caregivers OHIP - patients OHIP) as the dependent variable. Data were complete for 432 patients. The mean difference was 4.4 (standard deviation = 8.2; higher scores indicated a higher impact on OHRQoL). The variance due to patients was partly explained by their age, gender, and number of teeth, with a greater OHIP difference for older vs. younger patients, for women than for men, and in patients with fewer teeth. Almost 30% of the variance was due to caregivers, while the effect of clinics was not significant. It is important to study the possible causes of the different judgments concerning patients' OHRQoL by patients and caregivers, in order to improve the patients' satisfaction with care.

Biosimilars: Here and Now.

PubMed

Lemery, Steven J; Esteva, Francisco J; Weise, Martina

2016-01-01

Congress passed the Biologics Price Competition and Innovation Act (BPCI Act) as part of the Affordable Care Act on March 23, 2010. The BPCI Act authorized an approval pathway for biosimilar and interchangeable products. It defines biosimilarity to mean "that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components" and that "there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product." The biosimilar pathway has the potential to facilitate access to biologic products through increased competition, in the same manner as biosimilars have done for almost 10 years in Europe. The goal of a biosimilar program is not to independently establish safety and effectiveness for each condition of use. Rather, the goal is to demonstrate biosimilarity through an extensive analytical characterization and a targeted clinical program designed to assess for clinically meaningful differences, if they exist. The regulatory approaches in both the United States and Europe involve a totality-of-the-evidence approach to demonstrate biosimilarity. Importantly, the biosimilar pathway allows for extrapolation of data across indications so that a sponsor, with adequate scientific justification, need not conduct clinical studies in each intended condition of use. Without extrapolation, development may not be feasible for many products, and patients and resources could be diverted from clinical studies of newer agents for cancer.

An evidence-based practice-oriented review focusing on canagliflozin in the management of type 2 diabetes

PubMed Central

Messana, Joseph A; Schwartz, Stanley S; Townsend, Raymond R

2017-01-01

Caring for patients with type 2 diabetes mellitus (T2DM) has entered an era with many recent additions to the regimens used to clinically control their hyperglycemia. The most recent class of agents approved by the Food and Drug Administration (FDA) for T2DM is the sodium–glucose-linked transporter type 2 (SGLT2) inhibitors, which work principally in the proximal tubule of the kidney to block filtered glucose reabsorption. In the few years attending this new class arrival in the market, there has been a great deal of interest generated by the novel mechanism of action of SGLT2 inhibitors and by recent large outcome trials suggesting benefit on important clinical outcomes such as death, cardiovascular disease and kidney disease progression. In this review, we focus on canagliflozin, the first-in-class marketed SGLT2 inhibitor in the USA. In some cases, we included data from other SGLT2 inhibitors, such as outcomes in clinical trials, important insights on clinical features and benefits, and adverse effects. These agents represent a fundamentally different way of controlling blood glucose and for the first time in T2DM care to offer the opportunity to reduce glucose, blood pressure, and weight with effects sustained for at least 2 years. Important side effects include genital mycotic infections and the potential for orthostatic hypotension and rare instances of normoglycemic ketoacidosis. Active ongoing clinical trials promise to deepen our experience with the potential benefits, as well as the clinical risks attending the use of this new group of antidiabetic agents. PMID:28255241

"There are too many, but never enough": qualitative case study investigating routine coding of clinical information in depression.

PubMed

Cresswell, Kathrin; Morrison, Zoe; Kalra, Dipak; Sheikh, Aziz

2012-01-01

We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined.

Analysis of Outcomes After TKA: Do All Databases Produce Similar Findings?

PubMed

Bedard, Nicholas A; Pugely, Andrew J; McHugh, Michael; Lux, Nathan; Otero, Jesse E; Bozic, Kevin J; Gao, Yubo; Callaghan, John J

2018-01-01

Use of large clinical and administrative databases for orthopaedic research has increased exponentially. Each database represents unique patient populations and varies in their methodology of data acquisition, which makes it possible that similar research questions posed to different databases might result in answers that differ in important ways. (1) What are the differences in reported demographics, comorbidities, and complications for patients undergoing primary TKA among four databases commonly used in orthopaedic research? (2) How does the difference in reported complication rates vary depending on whether only inpatient data or 30-day postoperative data are analyzed? Patients who underwent primary TKA during 2010 to 2012 were identified within the National Surgical Quality Improvement Programs (NSQIP), the Nationwide Inpatient Sample (NIS), the Medicare Standard Analytic Files (MED), and the Humana Administrative Claims database (HAC). NSQIP is a clinical registry that captures both inpatient and outpatient events up to 30 days after surgery using clinical reviewers and strict definitions for each variable. The other databases are administrative claims databases with their comorbidity and adverse event data defined by diagnosis and procedure codes used for reimbursement. NIS is limited to inpatient data only, whereas HAC and MED also have outpatient data. The number of patients undergoing primary TKA from each database was 48,248 in HAC, 783,546 in MED, 393,050 in NIS, and 43,220 in NSQIP. NSQIP definitions for comorbidities and surgical complications were matched to corresponding International Classification of Diseases, 9 Revision/Current Procedural Terminology codes and these coding algorithms were used to query NIS, MED, and HAC. Age, sex, comorbidities, and inpatient versus 30-day postoperative complications were compared across the four databases. Given the large sample sizes, statistical significance was often detected for small, clinically unimportant differences; thus, the focus of comparisons was whether the difference reached an absolute difference of twofold to signify an important clinical difference. Although there was a higher proportion of males in NIS and NSQIP and patients in NIS were younger, the difference was slight and well below our predefined threshold for a clinically important difference. There was variation in the prevalence of comorbidities and rates of postoperative complications among databases. The prevalence of chronic obstructive pulmonary disease (COPD) and coagulopathy in HAC and MED was more than twice that in NIS and NSQIP (relative risk [RR] for COPD: MED versus NIS 3.1, MED versus NSQIP 4.5, HAC versus NIS 3.6, HAC versus NSQIP 5.3; RR for coagulopathy: MED versus NIS 3.9, MED versus NSQIP 3.1, HAC versus NIS 3.3, HAC versus NSQIP 2.7; p < 0.001 for all comparisons). NSQIP had more than twice the obesity as NIS (RR 0.35). Rates of stroke within 30 days of TKA had more than a twofold difference among all databases (p < 0.001). HAC had more than twice the rates of 30-day complications at all endpoints compared with NSQIP and more than twice the 30-day infections as MED. A comparison of inpatient and 30-day complications rates demonstrated more than twice the amount of wound infections and deep vein thromboses is captured when data are analyzed out to 30 days after TKA (p < 0.001 for all comparisons). When evaluating research utilizing large databases, one must pay particular attention to the type of database used (administrative claims, clinical registry, or other kinds of databases), time period included, definitions utilized for specific variables, and the population captured to ensure it is best suited for the specific research question. Furthermore, with the advent of bundled payments, policymakers must meticulously consider the data sources used to ensure the data analytics match historical sources. Level III, therapeutic study.

Promoting public awareness of randomised clinical trials using the media: the 'Get Randomised' campaign.

PubMed

Mackenzie, Isla S; Wei, Li; Rutherford, Daniel; Findlay, Evelyn A; Saywood, Wendy; Campbell, Marion K; Macdonald, Thomas M

2010-02-01

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT * Recruitment is key to the success of clinical trials. * Many clinical trials fail to achieve adequate recruitment. * Public understanding and engagement in clinical research could be improved. WHAT THIS STUDY ADDS * 'Get Randomised' is the first campaign of its kind in the UK. * It is possible to improve public awareness of clinical research using the media. * Further work is needed to determine whether improved public awareness leads to increased participation in clinical research in the future. AIM To increase public awareness and understanding of clinical research in Scotland. METHODS A generic media campaign to raise public awareness of clinical research was launched in 2008. The 'Get Randomised' campaign was a Scotland-wide initiative led by the University of Dundee in collaboration with other Scottish universities. Television, radio and newspaper advertising showed leading clinical researchers, general practitioners and patients informing the public about the importance of randomised clinical trials (RCTs). 'Get Randomised' was the central message and interested individuals were directed to the http://www.getrandomised.org website for more information. To assess the impact of the campaign, cross-sectional surveys were conducted in representative samples of 1040 adults in Scotland prior to campaign launch and again 6 months later. RESULTS There was an improvement in public awareness of clinical trials following the campaign; 56.7% [95% confidence interval (CI) 51.8, 61.6] of the sample recalled seeing or hearing advertising about RCTs following the campaign compared with 14.8% (10.8, 18.9) prior to the campaign launch (difference = 41.4%; 95% CI for difference 35.6, 48.3; P < 0.01). Of those who recalled the advertising, 49% felt that the main message was that people should take part more in medical research. However, on whether they would personally take part in a clinical trial if asked, there was little difference in response following the campaign ['yes' 31.3% (28.4, 34.1) prior; 30.4% (27.6, 33.2) following; difference =-0.9%; 95% CI for difference -4.8, 3.1%; P= 0.92]. CONCLUSIONS It is possible to raise public awareness of clinical research using the media, but further efforts may be required to influence individuals' decisions to take part in clinical research.

Tendon Tissue Engineering: Progress, Challenges, and Translation to the Clinic

PubMed Central

Shearn, Jason T.; Kinneberg, Kirsten R.C.; Dyment, Nathaniel A.; Galloway, Marc T.; Kenter, Keith; Wylie, Christopher; Butler, David L.

2013-01-01

The tissue engineering field has made great strides in understanding how different aspects of tissue engineered constructs (TECs) and the culture process affect final tendon repair. However, there remain significant challenges in developing strategies that will lead to a clinically effective and commercially successful product. In an effort to increase repair quality, a better understanding of normal development, and how it differs from adult tendon healing, may provide strategies to improve tissue engineering. As tendon tissue engineering continues to improve, the field needs to employ more clinically relevant models of tendon injury such as degenerative tendons. We need to translate successes to larger animal models to begin exploring the clinical implications of our treatments. By advancing the models used to validate our TECs, we can help convince our toughest customer, the surgeon, that our products will be clinically efficacious. As we address these challenges in musculoskeletal tissue engineering, the field still needs to address the commercialization of products developed in the laboratory. TEC commercialization faces numerous challenges because each injury and patient is unique. This review aims to provide tissue engineers with a summary of important issues related to engineering tendon repairs and potential strategies for producing clinically successful products. PMID:21625053

Bone marrow biopsy in monoclonal gammopathies: correlations between pathological findings and clinical data. The Cooperative Group for Study and Treatment of Multiple Myeloma.

PubMed Central

Riccardi, A; Ucci, G; Luoni, R; Castello, A; Coci, A; Magrini, U; Ascari, E

1990-01-01

Between January 1987 and October 1989, 561 consecutive untreated patients with monoclonal gammopathy of undetermined clinical importance (MGUS) (n = 295) or with multiple myeloma (n = 266) were evaluated in a multicentre trial. Both bone marrow biopsy and aspiration (performed at different anatomical sites) were required at presentation. Bone marrow biopsy data indicated that changes in bone marrow composition from MGUS to early multiple myeloma and to advanced multiple myeloma followed a precise pattern, including an increased percentage of bone marrow plasma cells (BMPC%), a shift from plasmocytic to plasmoblastic cytology, an increase in bone marrow cellularity and fibrosis, a change in bone marrow infiltration (becoming diffuse rather than interstitial), a decrease in residual haemopoiesis and an increase in osteoclasts. In multiple myeloma the BMPC% of biopsy specimens and aspirate were closely related, although in 5% of cases the difference between the two values was greater than 20%. Some histological features were remarkably associated with each other. For example, BMPC% was higher in cases with plasmoblastic cytology, heavy fibrosis, or reduced residual haemopoiesis. Anaemia was the clinical characteristic most influenced by bone marrow histology. The BMPC% was the only histological variable which affected the greatest number of clinical and laboratory characteristics, including, besides haemoglobin concentration, erythrocyte sedimentation rate, radiographic skeletal bone disease, and serum concentrations of monoclonal component, calcium, beta 2-microglobulin and thymidine kinase activity. These data indicate that comparative bone marrow histology in monoclonal gammopathies has clinical importance. Images PMID:2199532

Measuring workload for tuberculosis service provision at primary care level: a methodology

PubMed Central

2012-01-01

We developed and piloted a methodology to establish TB related work load at primary care level for clinical and laboratory staff. Workload is influenced by activities to be implemented, time to perform them, their frequency and patient load. Of particular importance is the patient pathway for diagnosis and treatment and the frequency of clinic visits. Using observation with checklists, clocking, interviews and review of registers, allows assessing the contribution of different factors on the workload. PMID:22640406

[Superior vena cava syndrome--clinical aspects, etiology and case reports].

PubMed

Serdarevic, M; Löhr, E; Reidemeister, J C

1984-06-01

The so-called superior-Cava Syndrome is caused by obstructions by centrally localized tumors by thrombosis or by inflammations of the mediastinum. In cases of tumorous infiltration a graft can be inserted. The different phenomena of thrombosis caused by nutritial catheters and pace makers are of clinical importance. Acute thrombosis of the brachio-cervical veins and the Vena Cava can be treated successfully by means of thrombolysis. Besides CT bilateral brachial phlebography communicates optimal information concerning localization of vascular obstruction and collateral circuits.

International network of cancer genome projects

PubMed Central

2010-01-01

The International Cancer Genome Consortium (ICGC) was launched to coordinate large-scale cancer genome studies in tumors from 50 different cancer types and/or subtypes that are of clinical and societal importance across the globe. Systematic studies of over 25,000 cancer genomes at the genomic, epigenomic, and transcriptomic levels will reveal the repertoire of oncogenic mutations, uncover traces of the mutagenic influences, define clinically-relevant subtypes for prognosis and therapeutic management, and enable the development of new cancer therapies. PMID:20393554

Electrophysiological Measures of Regional Neural Interactive Coupling (Linear and Nonlinear Dependence Relationships Among Multiple Channel Electroencephalographic (EEG) Recordings),

DTIC Science & Technology

1980-01-01

clinical intervention . SG1CUDING CCMENL’ In evaluating the EEGs of subjects it is important to not that . ~major differences in EEG waveshape across...studies in dyslexia . In A.L. Benton and D. Pearl (Fs.), Dyslexia : An Appraisal of Current Knowledge. New York: Oxford University Press, 1978. 4...Electroencephalo- graphy and Clinical Neurophysio !. Oct., 67, 23(4):306-19. 6) Duffy, F.H., Denckla, M.B., Bartels, P.H., and Sandini, G. Dyslexia

Opiate pharmacology and relief of pain.

PubMed

Pasternak, Gavril W

2014-06-01

Opioids remain the mainstay of severe pain management in patients with cancer. The hallmark of pain management is individualization of therapy. Although almost all clinically used drugs act through mu opioid receptors, they display subtle but important differences pharmacologically. Furthermore, not all patients respond equally well to all drugs. Evidence suggests that these variable responses among patients have a biologic basis and are likely to involve both biased agonism and the many mu opioid receptor subtypes that have been cloned. © 2014 by American Society of Clinical Oncology.

A novel diagram and complement to the CONSORT chart for presenting multimodal clinical trials.

PubMed

Schuller, Jan C; Mayer, Michael; Lanz, Doris; Schmitz, Shu-Fang Hsu; Brauchli, Peter; Leupin, Nicolas

2009-05-01

We developed a novel diagram to depict patient flow and outcomes in clinical trials. In contrast to flow diagrams such as the CONSORT chart, our diagram enables individual patient histories to be traced and depicts important patterns of treatment administration and outcomes, such as response and adverse events. Also, it is particularly useful for multimodal treatments or a sequence of different therapies where the CONSORT flow chart is less informative and can be confusing.

Screening midlife women for sleep problems: why, how, and who should get a referral?

PubMed

Lee, Kathryn A; Anderson, Debra J

2015-07-01

Advancements in sleep medicine have been escalating ever since research began appearing in the 1950s. As with most early clinical trials, women were excluded from participation. Even if researchers included women or addressed sex differences by age, reproductive stage was seldom considered. Recently, there has been an exponential increase in research on sleep in midlife and older women. This Practice Pearl briefly reviews the importance of adequate sleep, clinical assessment for sleep disorders, and guidelines for practice.

Working memory, reasoning, and expertise in medicine-insights into their relationship using functional neuroimaging.

PubMed

Hruska, Pam; Krigolson, Olav; Coderre, Sylvain; McLaughlin, Kevin; Cortese, Filomeno; Doig, Christopher; Beran, Tanya; Wright, Bruce; Hecker, Kent G

2016-12-01

Clinical reasoning is dependent upon working memory (WM). More precisely, during the clinical reasoning process stored information within long-term memory is brought into WM to facilitate the internal deliberation that affords a clinician the ability to reason through a case. In the present study, we examined the relationship between clinical reasoning and WM while participants read clinical cases with functional magnetic resonance imaging (fMRI). More specifically, we examined the impact of clinical case difficulty (easy, hard) and clinician level of expertise (2nd year medical students, senior gastroenterologists) on neural activity within regions of cortex associated with WM (i.e., the prefrontal cortex) during the reasoning process. fMRI was used to scan ten second-year medical students and ten practicing gastroenterologists while they reasoned through sixteen clinical cases [eight straight forward (easy) and eight complex (hard)] during a single 1-h scanning session. Within-group analyses contrasted the easy and hard cases which were then subsequently utilized for a between-group analysis to examine effects of expertise (novice > expert, expert > novice). Reading clinical cases evoked multiple neural activations in occipital, prefrontal, parietal, and temporal cortical regions in both groups. Importantly, increased activation in the prefrontal cortex in novices for both easy and hard clinical cases suggests novices utilize WM more so than experts during clinical reasoning. We found that clinician level of expertise elicited differential activation of regions of the human prefrontal cortex associated with WM during clinical reasoning. This suggests there is an important relationship between clinical reasoning and human WM. As such, we suggest future models of clinical reasoning take into account that the use of WM is not consistent throughout all clinical reasoning tasks, and that memory structure may be utilized differently based on level of expertise.

The Need for Data-Informed Clinical Supervision in Substance Use Disorder Treatment

PubMed Central

Ramsey, Alex T.; Baumann, Ana; Silver Wolf, David Patterson; Yan, Yan; Cooper, Ben; Proctor, Enola

2017-01-01

Background Effective clinical supervision is necessary for high-quality care in community-based substance use disorder treatment settings, yet little is known about current supervision practices. Some evidence suggests that supervisors and counselors differ in their experiences of clinical supervision; however, the impact of this misalignment on supervision quality is unclear. Clinical information monitoring systems may support supervision in substance use disorder treatment, but the potential use of these tools must first be explored. Aims First, this study examines the extent to which misaligned supervisor-counselor perceptions impact supervision satisfaction and emphasis on evidence-based treatments. This study also reports on formative work to develop a supervision-based clinical dashboard, an electronic information monitoring system and data visualization tool providing real-time clinical information to engage supervisors and counselors in a coordinated and data-informed manner, help align supervisor-counselor perceptions about supervision, and improve supervision effectiveness. Methods Clinical supervisors and frontline counselors (N=165) from five Midwestern agencies providing substance abuse services completed an online survey using Research Electronic Data Capture (REDCap) software, yielding a 75% response rate. Valid quantitative measures of supervision effectiveness were assessed, along with qualitative perceptions of a supervision-based clinical dashboard. Results Through within-dyad analyses, misalignment between supervisor and counselor perceptions of supervision practices was negatively associated with satisfaction of supervision and reported frequency of discussing several important clinical supervision topics, including evidence-based treatments and client rapport. Participants indicated the most useful clinical dashboard functions and reported important benefits and challenges to using the proposed tool. Discussion Clinical supervision tends to be largely an informal and unstructured process in substance abuse treatment, which may compromise the quality of care. Clinical dashboards may be a well-targeted approach to facilitate data-informed clinical supervision in community-based treatment agencies. PMID:28166480

The need for data-informed clinical supervision in substance use disorder treatment.

PubMed

Ramsey, Alex T; Baumann, Ana; Patterson Silver Wolf, David; Yan, Yan; Cooper, Ben; Proctor, Enola

2017-01-01

Effective clinical supervision is necessary for high-quality care in community-based substance use disorder treatment settings, yet little is known about current supervision practices. Some evidence suggests that supervisors and counselors differ in their experiences of clinical supervision; however, the impact of this misalignment on supervision quality is unclear. Clinical information monitoring systems may support supervision in substance use disorder treatment, but the potential use of these tools must first be explored. First, the current study examines the extent to which misaligned supervisor-counselor perceptions impact supervision satisfaction and emphasis on evidence-based treatments. This study also reports on formative work to develop a supervision-based clinical dashboard, an electronic information monitoring system and data visualization tool providing real-time clinical information to engage supervisors and counselors in a coordinated and data-informed manner, help align supervisor-counselor perceptions about supervision, and improve supervision effectiveness. Clinical supervisors and frontline counselors (N = 165) from five Midwestern agencies providing substance abuse services completed an online survey using Research Electronic Data Capture software, yielding a 75% response rate. Valid quantitative measures of supervision effectiveness were administered, along with qualitative perceptions of a supervision-based clinical dashboard. Through within-dyad analyses, misalignment between supervisor and counselor perceptions of supervision practices was negatively associated with satisfaction of supervision and reported frequency of discussing several important clinical supervision topics, including evidence-based treatments and client rapport. Participants indicated the most useful clinical dashboard functions and reported important benefits and challenges to using the proposed tool. Clinical supervision tends to be largely an informal and unstructured process in substance abuse treatment, which may compromise the quality of care. Clinical dashboards may be a well-targeted approach to facilitate data-informed clinical supervision in community-based treatment agencies.

Adolescent views on comprehensive health risk assessment and counseling: assessing gender differences.

PubMed

Kadivar, Hajar; Thompson, Lindsay; Wegman, Martin; Chisholm, TaJuana; Khan, Maryum; Eddleton, Katie; Muszynski, Michael; Shenkman, Elizabeth

2014-07-01

Adolescence is an important time for the detection of health risk behaviors and factors with subsequent counseling and intervention. Limited research has examined adolescent perceptions of comprehensive health risk assessments (HRAs) and counseling with an assessment of gender differences. Participants were identified using Florida's Medicaid and State Children's Health Insurance Program databases. A total of 35 low-income, racially/ethnically diverse adolescents (ages 14-18 years) participated in eight focus groups stratified by gender. Adolescents completed an internet-based, tablet-administered, comprehensive HRA and then participated in a semi-structured interview. Discussions were recorded, transcribed, and analyzed using a multi-step, team-based approach applying grounded theory to determine major themes. Male adolescents desired less parental involvement, had less understanding of the protections of clinical confidentiality and the need for comprehensive HRA, and placed greater emphasis on the importance of professional appearance. In contrast, more females valued face-to-face interactions and stressed the importance of concern from the health risk assessor. Overall, adolescents placed importance on their relationship with the health risk assessor, and on valuing trust, confidentiality, and nonjudgmental care. Adolescents preferred to complete HRAs in clinical, private, and professional settings, and reported that tablet technology supported their confidentially in completing the HRA. Furthermore, they stressed the importance of autonomy and learning about the health risk outcomes for risk reduction. Gender differences exist in adolescent perceptions of comprehensive HRAs. Adolescent perceptions of HRAs support their use in confidential primary care settings using modalities that emphasize nonjudgmental, private care, and the use of communication techniques that respect adolescents' autonomy to change health risks. Copyright © 2014. Published by Elsevier Inc.

Use of Wearable Sensors and Biometric Variables in an Artificial Pancreas System

PubMed Central

Turksoy, Kamuran; Monforti, Colleen; Park, Minsun; Griffith, Garett; Quinn, Laurie; Cinar, Ali

2017-01-01

An artificial pancreas (AP) computes the optimal insulin dose to be infused through an insulin pump in people with Type 1 Diabetes (T1D) based on information received from a continuous glucose monitoring (CGM) sensor. It has been recognized that exercise is a major challenge in the development of an AP system. The use of biometric physiological variables in an AP system may be beneficial for prevention of exercise-induced challenges and better glucose regulation. The goal of the present study is to find a correlation between biometric variables such as heart rate (HR), heat flux (HF), skin temperature (ST), near-body temperature (NBT), galvanic skin response (GSR), and energy expenditure (EE), 2D acceleration-mean of absolute difference (MAD) and changes in glucose concentrations during exercise via partial least squares (PLS) regression and variable importance in projection (VIP) in order to determine which variables would be most useful to include in a future artificial pancreas. PLS and VIP analyses were performed on data sets that included seven different types of exercises. Data were collected from 26 clinical experiments. Clinical results indicate ST to be the most consistently important (important for six out of seven tested exercises) variable over all different exercises tested. EE and HR are also found to be important variables over several types of exercise. We also found that the importance of GSR and NBT observed in our experiments might be related to stress and the effect of changes in environmental temperature on glucose concentrations. The use of the biometric measurements in an AP system may provide better control of glucose concentration. PMID:28272368

Actinomycetes: still a source of novel antibiotics.

PubMed

Genilloud, Olga

2017-10-18

Covering: 2006 to 2017Actinomycetes have been, for decades, one of the most important sources for the discovery of new antibiotics with an important number of drugs and analogs successfully introduced in the market and still used today in clinical practice. The intensive antibacterial discovery effort that generated the large number of highly potent broad-spectrum antibiotics, has seen a dramatic decline in the large pharma industry in the last two decades resulting in a lack of new classes of antibiotics with novel mechanisms of action reaching the clinic. Whereas the decline in the number of new chemical scaffolds and the rediscovery problem of old known molecules has become a hurdle for industrial natural products discovery programs, new actinomycetes compounds and leads have continued to be discovered and developed to the preclinical stages. Actinomycetes are still one of the most important sources of chemical diversity and a reservoir to mine for novel structures that is requiring the integration of diverse disciplines. These can range from novel strategies to isolate species previously not cultivated, innovative whole cell screening approaches and on-site analytical detection and dereplication tools for novel compounds, to in silico biosynthetic predictions from whole gene sequences and novel engineered heterologous expression, that have inspired the isolation of new NPs and shown their potential application in the discovery of novel antibiotics. This review will address the discovery of antibiotics from actinomycetes from two different perspectives including: (1) an update of the most important antibiotics that have only reached the clinical development in the recent years despite their early discovery, and (2) an overview of the most recent classes of antibiotics described from 2006 to 2017 in the framework of the different strategies employed to untap novel compounds previously overlooked with traditional approaches.

The sweet spot of clinical intuitions: Predictors of the effects of context on impressions of conduct disorder symptoms.

PubMed

Marsh, Jessecae K; Burke, Christopher T; De Los Reyes, Andres

2016-02-01

How people interpret a mental disorder symptom has been shown to depend on the contextual life factors surrounding its presentation. Specifically, people are more likely to judge a symptom as clinically relevant if that symptom presents in a high-risk environment (e.g., child associates with deviant peers) relative to a low-risk environment (e.g., child associates with normative peer group). Importantly, not all symptoms are influenced by context to the same extent, and there is low agreement across people as to how this influence manifests. In this paper, we explore what factors predict the extent to which clinicians and laypeople interpret mental disorder symptoms as a function of diagnosis-congruent versus incongruent contextual information. We tested the impact of 2 statistical factors (prevalence and diagnosticity) and 2 more intuitive factors (diagnostic importance and abnormality) on the degree to which a symptom is interpreted differently in different contexts. Clinicians' impressions of the diagnosticity and importance of a symptom evidenced a curvilinear relationship with the use of context, with extremely important and unimportant as well as extremely diagnostic and nondiagnostic symptoms being less influenced by context. Laypeople showed a similar curvilinear relation between diagnosticity judgments and context effects. Additionally, clinicians showed a linear relationship between abnormality judgments and context use, with extremely abnormal symptoms being influenced less by context, whereas laypeople showed a curvilinear relationship between symptom abnormality and context use, with extremely abnormal and normal symptoms being influenced the most by context. We discuss implications of these findings for clinical diagnosis. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Clinical knowledge-based inverse treatment planning

NASA Astrophysics Data System (ADS)

Yang, Yong; Xing, Lei

2004-11-01

Clinical IMRT treatment plans are currently made using dose-based optimization algorithms, which do not consider the nonlinear dose-volume effects for tumours and normal structures. The choice of structure specific importance factors represents an additional degree of freedom of the system and makes rigorous optimization intractable. The purpose of this work is to circumvent the two problems by developing a biologically more sensible yet clinically practical inverse planning framework. To implement this, the dose-volume status of a structure was characterized by using the effective volume in the voxel domain. A new objective function was constructed with the incorporation of the volumetric information of the system so that the figure of merit of a given IMRT plan depends not only on the dose deviation from the desired distribution but also the dose-volume status of the involved organs. The conventional importance factor of an organ was written into a product of two components: (i) a generic importance that parametrizes the relative importance of the organs in the ideal situation when the goals for all the organs are met; (ii) a dose-dependent factor that quantifies our level of clinical/dosimetric satisfaction for a given plan. The generic importance can be determined a priori, and in most circumstances, does not need adjustment, whereas the second one, which is responsible for the intractable behaviour of the trade-off seen in conventional inverse planning, was determined automatically. An inverse planning module based on the proposed formalism was implemented and applied to a prostate case and a head-neck case. A comparison with the conventional inverse planning technique indicated that, for the same target dose coverage, the critical structure sparing was substantially improved for both cases. The incorporation of clinical knowledge allows us to obtain better IMRT plans and makes it possible to auto-select the importance factors, greatly facilitating the inverse planning process. The new formalism proposed also reveals the relationship between different inverse planning schemes and gives important insight into the problem of therapeutic plan optimization. In particular, we show that the EUD-based optimization is a special case of the general inverse planning formalism described in this paper.

Clinical COPD Questionnaire in patients with chronic respiratory disease.

PubMed

Canavan, Jane L; Dilaver, Deniz; Clark, Amy L; Jones, Sarah E; Nolan, Claire M; Kon, Samantha S C; Man, William D-C

2014-10-01

The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (CCQ) is an easy to complete, health-related quality of life questionnaire which has been well-validated in COPD. The responsiveness of the CCQ in chronic respiratory disease patients other than COPD has not been previously described. The study aims were to determine if the CCQ in chronic respiratory disease correlates with other health related quality of life questionnaires, to assess the responsiveness of the CCQ to pulmonary rehabilitation and to determine the minimum important difference. The CCQ, COPD Assessment Test (CAT), the Chronic Respiratory Questionnaire (CRQ) and St George's Respiratory Questionnaire (SGRQ) were measured in 138 chronic respiratory disease patients completing pulmonary rehabilitation. Change in CCQ with pulmonary rehabilitation was correlated with change in the other questionnaires. The minimum important difference of the CCQ was calculated using distribution and anchor-based approaches. The CCQ, CAT, CRQ and SGRQ improved significantly with rehabilitation with effect sizes of -0.43, -0.26, 0.62, -0.37. Change in CCQ correlated significantly with CAT, CRQ and SGRQ (r = 0.53, -0.64, 0.30, all P < 0.0001). The minimum important difference was -0.42 at the population level and -0.4 at the individual level. The CCQ is responsive to pulmonary rehabilitation in chronic respiratory disease patients, with an MID estimated at -0.4 at the individual level. © 2014 Asian Pacific Society of Respirology.

So different, yet so similar: meta-analysis and policy modeling of willingness to participate in clinical trials among Brazilians and Indians.

PubMed

Zammar, Guilherme; Meister, Henrique; Shah, Jatin; Phadtare, Amruta; Cofiel, Luciana; Pietrobon, Ricardo

2010-12-16

With the global expansion of clinical trials and the expectations of the rise of the emerging economies known as BRICs (Brazil, Russia, India and China), the understanding of factors that affect the willingness to participate in clinical trials of patients from those countries assumes a central role in the future of health research. We conducted a systematic review and meta-analysis (SRMA) of willingness to participate in clinical trials among Brazilian patients and then we compared it with Indian patients (with results of another SRMA previously conducted by our group) through a system dynamics model. Five studies were included in the SRMA of Brazilian patients. Our main findings are 1) the major motivation for Brazilian patients to participate in clinical trials is altruism, 2) monetary reimbursement is the least important factor motivating Brazilian patients, 3) the major barrier for Brazilian patients to not participate in clinical trials is the fear of side effects, and 4) Brazilian patients are more likely willing to participate in clinical trials than Indians. Our study provides important insights for investigators and sponsors for planning trials in Brazil (and India) in the future. Ignoring these results may lead to unnecessary fund/time spending. More studies are needed to validate our results and for better understanding of this poorly studied theme.

Formulary considerations in selection of beta-blockers.

PubMed

Yedinak, K C

1993-08-01

Selection of beta-adrenergic blockers for formulary addition can be a difficult task, especially with the increasing availability of new beta-blockers, as well as the numerous differences in pharmacodynamic and pharmacokinetic properties of currently available agents. Nevertheless, appropriate evaluation of the important characteristics of beta-blockers should allow selection of the most cost-effective agents for formulary addition. Most importantly, differences in efficacy, product formulation and cost should be carefully considered when making formulary decisions. Notably, evidence from clinical trials indicates differences in efficacy among beta-blockers for post-myocardial infarction prophylaxis, situational anxiety, essential tremor, thyrotoxicosis, migraine prophylaxis and prevention of bleeding associated with oesophageal varices. For many clinical situations, it is also important to select an effective agent that is available in both an oral and intravenous formulation, especially for cardioprotection after acute myocardial infarction and for use in supraventricular arrhythmias. In addition, availability of sustained release products and generic formulations should be considered for their potential to increase compliance and decrease cost, respectively. Comparative drug costs, as well as costs associated with decreased compliance, should also be carefully evaluated. Differences in beta-receptor selectivity, duration of action and presence of intrinsic sympathomimetic activity (ISA) are also important considerations in the selection of beta-blockers for formulary consideration. Although degree of selectivity is relative, beta 1-selective agents may be less likely to induce bronchospasm in patients with chronic obstructive pulmonary disease (COPD) and may be less likely to affect glucose homeostasis in patients with diabetes mellitus. Duration of action of a beta-blocker is an important consideration for evaluation of efficacy throughout the recommended dosage interval. In addition, beta-blockers with a long duration of action can often be administered once or twice daily, potentially leading to increased compliance and thereby improved effectiveness and economic efficiency. The presence of ISA is an important consideration because certain beta-blockers with ISA may be less effective than those without ISA for certain indications. Factors considered to be less important when making formulary decisions of choice of beta-blockers include the route of elimination, lipophilicity and presence of membrane stabilising activity.

Competence of novice nurses: role of clinical work during studying

PubMed Central

Manoochehri, H; Imani, E; Atashzadeh-Shoorideh, F; Alavi-Majd, A

2015-01-01

Aim: Clinical competence is to carry out the tasks with excellent results in a different of adjustments. According to various studies, one of the factors influencing clinical competence is work experience. This experience affects the integrity of students' learning experience and their practical skills. Many nursing students practice clinical work during their full-time studying. The aim of this qualitative research was to clarify the role of clinical work during studying in novice nurses' clinical competence. Methods: This qualitative content analysis performed with the conventional approach. All teaching hospitals of Hormozgan University of Medical Sciences selected as the research environment. To collect data, deep and semi-structured interviews, presence in the scene and manuscripts used. To provide feedback for the next release and the capacity of the data, interviews were transcribed verbatim immediately. Results: 45 newly-graduated nurses and head nurses between 23 and 40 with 1 to 18 years of experience participated in the study. After coding all interviews, 1250 original codes were derived. The themes extracted included: task rearing, personality rearing, knowledge rearing, and profession rearing roles of clinical work during studying. Conclusion: Working during studying can affect performance, personality, knowledge, and professional perspectives of novice nurses. Given the differences that may exist in clinical competencies of novice nurses with and without clinical work experience, it is important to pay more attention to this issue and emphasize on their learning in this period. PMID:28316703

The protozoan parasite Trichomonas gallinae causes adult and nestling mortality in a declining population of European Turtle Doves, Streptopelia turtur.

PubMed

Stockdale, Jennifer E; Dunn, Jenny C; Goodman, Simon J; Morris, Antony J; Sheehan, Danaë K; Grice, Philip V; Hamer, Keith C

2015-03-01

Studies incorporating the ecology of clinical and sub-clinical disease in wild populations of conservation concern are rare. Here we examine sub-clinical infection by Trichomonas gallinae in a declining population of free-living European Turtle Doves and suggest caseous lesions cause mortality in adults and nestlings through subsequent starvation and/or suffocation. We found a 100% infection rate by T. gallinae in adult and nestling Turtle Doves (n = 25) and observed clinical signs in three adults and four nestlings (28%). Adults with clinical signs displayed no differences in any skeletal measures of size but had a mean 3.7% reduction in wing length, with no overlap compared to those without clinical signs. We also identified T. gallinae as the suggested cause of mortality in one Red-legged Partridge although disease presentation was different. A minimum of four strains of T. gallinae, characterized at the ITS/5.8S/ITS2 ribosomal region, were isolated from Turtle Doves. However, all birds with clinical signs (Turtle Doves and the Red-legged Partridge) carried a single strain of T. gallinae, suggesting that parasite spill over between Columbidae and Galliformes is a possibility that should be further investigated. Overall, we highlight the importance of monitoring populations for sub-clinical infection rather than just clinical disease.

Clinical validation of robot simulation of toothbrushing - comparative plaque removal efficacy

PubMed Central

2014-01-01

Background Clinical validation of laboratory toothbrushing tests has important advantages. It was, therefore, the aim to demonstrate correlation of tooth cleaning efficiency of a new robot brushing simulation technique with clinical plaque removal. Methods Clinical programme: 27 subjects received dental cleaning prior to 3-day-plaque-regrowth-interval. Plaque was stained, photographically documented and scored using planimetrical index. Subjects brushed teeth 33–47 with three techniques (horizontal, rotating, vertical), each for 20s buccally and for 20s orally in 3 consecutive intervals. The force was calibrated, the brushing technique was video supported. Two different brushes were randomly assigned to the subject. Robot programme: Clinical brushing programmes were transfered to a 6-axis-robot. Artificial teeth 33–47 were covered with plaque-simulating substrate. All brushing techniques were repeated 7 times, results were scored according to clinical planimetry. All data underwent statistical analysis by t-test, U-test and multivariate analysis. Results The individual clinical cleaning patterns are well reproduced by the robot programmes. Differences in plaque removal are statistically significant for the two brushes, reproduced in clinical and robot data. Multivariate analysis confirms the higher cleaning efficiency for anterior teeth and for the buccal sites. Conclusions The robot tooth brushing simulation programme showed good correlation with clinically standardized tooth brushing. This new robot brushing simulation programme can be used for rapid, reproducible laboratory testing of tooth cleaning. PMID:24996973

Clinical validation of robot simulation of toothbrushing--comparative plaque removal efficacy.

PubMed

Lang, Tomas; Staufer, Sebastian; Jennes, Barbara; Gaengler, Peter

2014-07-04

Clinical validation of laboratory toothbrushing tests has important advantages. It was, therefore, the aim to demonstrate correlation of tooth cleaning efficiency of a new robot brushing simulation technique with clinical plaque removal. Clinical programme: 27 subjects received dental cleaning prior to 3-day-plaque-regrowth-interval. Plaque was stained, photographically documented and scored using planimetrical index. Subjects brushed teeth 33-47 with three techniques (horizontal, rotating, vertical), each for 20s buccally and for 20s orally in 3 consecutive intervals. The force was calibrated, the brushing technique was video supported. Two different brushes were randomly assigned to the subject. Robot programme: Clinical brushing programmes were transfered to a 6-axis-robot. Artificial teeth 33-47 were covered with plaque-simulating substrate. All brushing techniques were repeated 7 times, results were scored according to clinical planimetry. All data underwent statistical analysis by t-test, U-test and multivariate analysis. The individual clinical cleaning patterns are well reproduced by the robot programmes. Differences in plaque removal are statistically significant for the two brushes, reproduced in clinical and robot data. Multivariate analysis confirms the higher cleaning efficiency for anterior teeth and for the buccal sites. The robot tooth brushing simulation programme showed good correlation with clinically standardized tooth brushing.This new robot brushing simulation programme can be used for rapid, reproducible laboratory testing of tooth cleaning.

Methodology for Knowledge Synthesis of the Management of Vaccination Pain and Needle Fear.

PubMed

Taddio, Anna; McMurtry, C Meghan; Shah, Vibhuti; Yoon, Eugene W; Uleryk, Elizabeth; Pillai Riddell, Rebecca; Lang, Eddy; Chambers, Christine T; Noel, Melanie; MacDonald, Noni E

2015-10-01

A knowledge synthesis was undertaken to inform the development of a revised and expanded clinical practice guideline about managing vaccination pain in children to include the management of pain across the lifespan and the management of fear in individuals with high levels of needle fear. This manuscript describes the methodological details of the knowledge synthesis and presents the list of included clinical questions, critical and important outcomes, search strategy, and search strategy results. The Grading of Assessments, Recommendations, Development and Evaluation (GRADE) and Cochrane methodologies provided the general framework. The project team voted on clinical questions for inclusion and critically important and important outcomes. A broad search strategy was used to identify relevant randomized-controlled trials and quasi-randomized-controlled trials. Quality of research evidence was assessed using the Cochrane risk of bias tool and quality across studies was assessed using GRADE. Multiple measures of the same construct within studies (eg, observer-rated and parent-rated infant distress) were combined before pooling. The standardized mean difference and 95% confidence intervals (CI) or relative risk and 95% CI was used to express the effects of an intervention. Altogether, 55 clinical questions were selected for inclusion in the knowledge synthesis; 49 pertained to pain management during vaccine injections and 6 pertained to fear management in individuals with high levels of needle fear. Pain, fear, and distress were typically prioritized as critically important outcomes across clinical questions. The search strategy identified 136 relevant studies. This manuscript describes the methodological details of a knowledge synthesis about pain management during vaccination and fear management in individuals with high levels of needle fear. Subsequent manuscripts in this series will present the results for the included questions.

Importance of intellectual property generated by biomedical research at universities and academic hospitals

PubMed Central

Heus, Joris J.; de Pauw, Elmar S.; Leloux, Mirjam; Morpurgo, Margherita; Hamblin, Michael R; Heger, Michal

2017-01-01

Biomedical research has many different facets. Researchers and clinicians study disease biology and biochemistry to discover novel therapeutic targets, unravel biochemical pathways and identify biomarkers to improve diagnosis, or devise new approaches to clinically manage diseases more effectively. In all instances, the overall goal of biomedical research is to ensure that results thereof (such as a therapy, a device, or a method which may be broadly referred to as “inventions”) are clinically implemented. Most of the researchers’ efforts are centered on the advance of technical and scientific aspects of an invention. The development and implementation of an invention can be arduous and very costly. Historically, it has proven to be crucial to protect intellectual property rights (IPR) to an invention (i.e., a patent) to ensure that companies can obtain a fair return on their investment that is needed to develop an academic invention into a product for the benefit of patients. However, the importance of IPR is not generally acknowledged among researchers at academic institutions active in biomedical research. Therefore this paper aims to (1) raise IP awareness amongst clinical and translational researchers; (2) provide a concise overview of what the patenting trajectory entails; and (3) highlight the importance of patenting for research and the researcher. Importance for patients Adequate patent protection of inventions generated through biomedical research at academic institutions increases the probability that patients will benefit from these inventions, and indirectly enables the financing of clinical studies, mainly by opening up funding opportunities (e.g. specific grants aimed at start-ups, pre-seed and seed capital) that otherwise would not be accessible. As a consequence, patented inventions are more likely to become clinically tested and reach the market, providing patients with more treatment options. PMID:29623295

Surgery or conservative treatment for rotator cuff tear: a meta-analysis.

PubMed

Ryösä, Anssi; Laimi, Katri; Äärimaa, Ville; Lehtimäki, Kaisa; Kukkonen, Juha; Saltychev, Mikhail

2017-07-01

Comparative evidence on treating rotator cuff tear is inconclusive. The objective of this review was to evaluate the evidence on effectiveness of tendon repair in reducing pain and improving function of the shoulder when compared with conservative treatment of symptomatic rotator cuff tear. Search on CENTRAL, MEDLINE, EMBASE, CINAHL, Web of Science and Pedro databases. Randomised controlled trials (RCT) comparing surgery and conservative treatment of rotator cuff tear. Study selection and extraction based on the Cochrane Handbook for Systematic reviews of Interventions. Random effects meta-analysis. Three identified RCTs involved 252 participants (123 cases and 129 controls). The risk of bias was considered low for all three RCTs. For Constant score, statistically insignificant effect size was 5.6 (95% CI -0.41 to 11.62) points in 1-year follow up favouring surgery and below the level of minimal clinically important difference. The respective difference in pain reduction was -0.93 (95% CI -1.65 to -0.21) cm on a 0-10 pain visual analogue scale favouring surgery. The difference was statistically significant (p = 0.012) in 1-year follow up but below the level of minimal clinically important difference. There is limited evidence that surgery is not more effective in treating rotator cuff tear than conservative treatment alone. Thus, a conservative approach is advocated as the initial treatment modality. Implications for Rehabilitation There is limited evidence that surgery is not more effective in treating rotator cuff tear than conservative treatment alone. There was no clinically significant difference between surgery and active physiotherapy in 1-year follow-up in improving Constant score or reducing pain caused by rotator cuff tear. As physiotherapy is less proneness to complications and less expensive than surgery, a conservative approach is advocated as the initial treatment modality to rotator cuff tears.

Multicentered Study Evaluating Pharmacy Students' Perception of Palliative Care and Clinical Reasoning Using Script Concordance Testing.

PubMed

Atayee, Rabia S; Lockman, Kashelle; Brock, Cara; Abazia, Daniel T; Brooks, Tracy L; Pawasauskas, Jayne; Edmonds, Kyle P; Herndon, Christopher M

2018-01-01

As the role of the pharmacist on the transdisciplinary palliative care team grows, the need for adequate instruction on palliative care and clinical reasoning skills in schools of pharmacy grows accordingly. This study evaluates second- and third-year pharmacy students from 6 accredited schools of pharmacy that participated in surveys before and after the delivery of a didactic palliative care elective. The survey collected student demographics, perceptions of the importance of and student skill level in palliative care topics. The script concordance test (SCT) was used to assess clinical decision-making skills on patient cases. Student scores on the SCT were compared to those of a reference panel of experts. A total of 89 students completed the pre-/postsurveys and were included in data analysis. There was no statistically significant difference in student perceived importance of palliative care skills before and after the elective. Students from all 6 institutions showed significant increase in confidence in their palliative care skills at the end of the course. There was also a significant improvement across all institutions in clinical reasoning skills in most of the SCT questions used to assess these skills. Students choosing an elective in palliative care likely do so because they already have an understanding of the importance of these topics in their future practice settings. Delivery of a palliative care elective in the pharmacy curriculum significantly increases both student confidence in their palliative care skills and their clinical reasoning skills in these areas.

Fathers and mothers with eating-disorder psychopathology: Associations with child eating-disorder behaviors.

PubMed

Lydecker, Janet A; Grilo, Carlos M

2016-07-01

A limited literature suggests an association between maternal eating disorders and child feeding difficulties, and notes maternal concern about inadvertently transmitting eating disorders. Thus, parents may be an important target for eating-disorder research to guide the development of clinical programs. The current study examined differences in child eating-disorder behaviors and parental feeding practices between a sample of parents (42 fathers, 130 mothers) exhibiting core features of anorexia nervosa, bulimia nervosa, binge-eating disorder, or purging disorder, and a matched sample of parents (n=172) reporting no eating-disorder characteristics. Parents with eating-disorder psychopathology were significantly more likely than parents without eating-disorder characteristics to report child binge-eating and compulsive exercise. Parents with eating-disorder psychopathology reported greater perceived feeding responsibility, greater concern about their child's weight, and more monitoring of their child's eating than parents without eating-disorder characteristics; however, they did not differ significantly in restriction of their child's diet and pressure-to-eat. Child body mass index z-scores did not differ between parents with versus without eating-disorder characteristics. Our findings suggest some important differences between parents with and without core eating-disorder psychopathology, which could augment clinical interventions for patients with eating disorders who are parents, or could guide pediatric eating-disorder prevention efforts. However, because our study was cross-sectional, findings could indicate increased awareness of or sensitivity to eating-disorder behaviors rather than a psychosocial cause of those behaviors. Longitudinal research and controlled trials examining prevention and intervention can clarify and address these clinical concerns. Copyright © 2016 Elsevier Inc. All rights reserved.

Fathers and mothers with eating-disorder psychopathology: Associations with child eating-disorder behaviors

PubMed Central

Lydecker, Janet A.; Grilo, Carlos M.

2016-01-01

Objective A limited literature suggests an association between maternal eating disorders and child feeding difficulties, and notes maternal concern about inadvertently transmitting eating disorders. Thus, parents may be an important target for eating-disorder research to guide the development of clinical programs. Methods The current study examined differences in child eating-disorder behaviors and parental feeding practices between a sample of parents (42 fathers, 130 mothers) exhibiting core features of anorexia nervosa, bulimia nervosa, binge-eating disorder, or purging disorder, and a matched sample of parents (n=172) reporting no eating-disorder characteristics. Results Parents with eating-disorder psychopathology were significantly more likely than parents without eating-disorder characteristics to report child binge-eating and compulsive exercise. Parents with eating-disorder psychopathology reported greater perceived feeding responsibility, greater concern about their child’s weight, and more monitoring of their child’s eating than parents without eating-disorder characteristics; however, they did not differ significantly in restriction of their child’s diet and pressure-to-eat. Child body mass index z-scores did not differ between parents with versus without eating-disorder characteristics. Conclusion Our findings suggest some important differences between parents with and without core eating-disorder psychopathology, which could augment clinical interventions for patients with eating disorders who are parents, or could guide pediatric eating-disorder prevention efforts. However, because our study was cross-sectional, findings could indicate increased awareness of or sensitivity to eating-disorder behaviors rather than a psychosocial cause of those behaviors. Longitudinal research and controlled trials examining prevention and intervention can clarify and address these clinical concerns. PMID:27302549

[Professor SONG Nanchang's experience for treatment of peripheral facial paralysis].

PubMed

He, Yong; Pan, Hao; Xu, Hanbin

2015-06-01

Professor SONG Nanchang's clinical experience and characteristics for treatment of peripheral facial paralysis are introduced. In clinical treatment, professor SONG has adopted staging treatment strategy, and performed acupuncture stimulation with different levels. He attaches great importance to the acupoint selection on distal limbs. For the treatment on the face, he takes temperature as necessity; he inherits from famous Chinese doctor ZONG Ruilin's acupuncture technique of slow-twisting and gentle-pressing. Meanwhile, he excels in combination, of different therapies, using acupuncture, moxibustion, electroacupuncture, auricular point sticking, Chinese herbal medicine, etc. according to individual condition and disease stages. He also emphasizes on psychological counseling and daily life care to achieve rehabilitation within the shortest time.

Beta-blockers use for hypertension in the elderly.

PubMed

Herrera, Julio

2015-01-01

Beta-blockers are considered as suitable drugs to treat essential hypertension also in elderly patients and they are currently recommended for treatment of hypertension, even in older patients, by the ESH/ESC Guidelines. Different meta-analyses and results of some large clinical trials have shown that here is no clinically difference between β-blockers and other drug classes in decreasing high blood pressure in elderly hypertensive patients. The new vasodilating β-blockers, as nebivolol, carvedilol and celiprolol, offer additional important advantages, compared with traditional β-blockers. The cardio-protective effect of β-blockers (except atenolol) is not inferior to that obtained with other drug classes which is independent of age and gender of the patients.

Assessment of Spectral-Domain Optical Coherence Tomography Findings in Three Cases of X-Linked Juvenile Retinoschisis in the Same Family.

PubMed

Doğuizi, Sibel; Şekeroğlu, Mehmet Ali; Çolak, Salih; Anayol, Mustafa Alpaslan; Yılmazbaş, Pelin

2017-10-01

X-linked juvenile retinoschisis (XLRS) is an X-linked hereditary retinal dystrophy characterized by splitting of the neurosensory retina. On fundus examination, the macula often has a spoke wheel appearance with foveal cystic lesions, and separation of the retinal layers is typical on spectral-domain optical coherence tomography (SD-OCT). Patients with XLRS can exhibit different clinical courses, stages, and SD-OCT findings, even among members of the same family. SD-OCT is an important imaging method that allows us to achieve more detailed information about XLRS. In this study, we report three patients in the same family who have different clinical features and SD-OCT findings.

International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology.

PubMed

Ghadri, Jelena-Rima; Wittstein, Ilan Shor; Prasad, Abhiram; Sharkey, Scott; Dote, Keigo; Akashi, Yoshihiro John; Cammann, Victoria Lucia; Crea, Filippo; Galiuto, Leonarda; Desmet, Walter; Yoshida, Tetsuro; Manfredini, Roberto; Eitel, Ingo; Kosuge, Masami; Nef, Holger M; Deshmukh, Abhishek; Lerman, Amir; Bossone, Eduardo; Citro, Rodolfo; Ueyama, Takashi; Corrado, Domenico; Kurisu, Satoshi; Ruschitzka, Frank; Winchester, David; Lyon, Alexander R; Omerovic, Elmir; Bax, Jeroen J; Meimoun, Patrick; Tarantini, Guiseppe; Rihal, Charanjit; Y-Hassan, Shams; Migliore, Federico; Horowitz, John D; Shimokawa, Hiroaki; Lüscher, Thomas Felix; Templin, Christian

2018-06-07

Takotsubo syndrome (TTS) is a poorly recognized heart disease that was initially regarded as a benign condition. Recently, it has been shown that TTS may be associated with severe clinical complications including death and that its prevalence is probably underestimated. Since current guidelines on TTS are lacking, it appears timely and important to provide an expert consensus statement on TTS. The clinical expert consensus document part I summarizes the current state of knowledge on clinical presentation and characteristics of TTS and agrees on controversies surrounding TTS such as nomenclature, different TTS types, role of coronary artery disease, and etiology. This consensus also proposes new diagnostic criteria based on current knowledge to improve diagnostic accuracy.

[The clinical and pathologic features of Charcot-Marie-Tooth disease].

PubMed

Xiao, Bo; Xie, Jusheng; Yang, Xiaosu; Wu, Zhiguo; Xiao, Jianfeng; Li, Jing

2002-11-01

To study the clinical and pathological features of Charcot-Marie-Tooth disease (CMT). The general clinical data, the changes of neuroelectrophysiology and the pathological features of neural and muscular biopsy of 20 CMT patients were comprehensively analyzed. The clinical manifestations in the two types of CMT were nearly the same, but the changes of neuroelectrophysiology and the pathological characteristics of the neural and muscular biopsy in the two types were obviously different. 16 cases of CMT type 1 were characterized by decreased sensory nerve conduction velocity (SNCV < 30 m/s) and are associated with demyelinating hypertrophic neuropathy. 4 cases of CMT tylpe 2 were characterized by normal SNCV and associated with axonopathy. Neuroelectrophysiology and neural and muscular biopsy are important for the diagnosis of CMT.

International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology

PubMed Central

Ghadri, Jelena-Rima; Wittstein, Ilan Shor; Prasad, Abhiram; Sharkey, Scott; Dote, Keigo; Akashi, Yoshihiro John; Cammann, Victoria Lucia; Crea, Filippo; Galiuto, Leonarda; Desmet, Walter; Yoshida, Tetsuro; Manfredini, Roberto; Eitel, Ingo; Kosuge, Masami; Nef, Holger M; Deshmukh, Abhishek; Lerman, Amir; Bossone, Eduardo; Citro, Rodolfo; Ueyama, Takashi; Corrado, Domenico; Kurisu, Satoshi; Ruschitzka, Frank; Winchester, David; Lyon, Alexander R; Omerovic, Elmir; Bax, Jeroen J; Meimoun, Patrick; Tarantini, Guiseppe; Rihal, Charanjit; Y.-Hassan, Shams; Migliore, Federico; Horowitz, John D; Shimokawa, Hiroaki; Lüscher, Thomas Felix; Templin, Christian

2018-01-01

Abstract Takotsubo syndrome (TTS) is a poorly recognized heart disease that was initially regarded as a benign condition. Recently, it has been shown that TTS may be associated with severe clinical complications including death and that its prevalence is probably underestimated. Since current guidelines on TTS are lacking, it appears timely and important to provide an expert consensus statement on TTS. The clinical expert consensus document part I summarizes the current state of knowledge on clinical presentation and characteristics of TTS and agrees on controversies surrounding TTS such as nomenclature, different TTS types, role of coronary artery disease, and etiology. This consensus also proposes new diagnostic criteria based on current knowledge to improve diagnostic accuracy. PMID:29850871

An Innovative Program to Support Internationally Educated Health Professionals and Their Instructors: Role of the Clinical Practice Facilitator.

PubMed

Daniel, Sylvia; Lee, Annemarie L; Switzer-McIntyre, Sharon; Evans, Cathy

2016-01-01

Internationally educated health professionals immigrating to other countries may experience difficulty in clinical practice, due to linguistic and cultural factors. An important element of bridging is the opportunity for internationally educated health professionals to practice in a clinical environment. To support these health professionals and their clinical instructors, a Clinical Practice Facilitator (CPF) role was created. This study aimed to examine the CPF from internationally educated health professionals and clinical instructors' perspective. A quantitative survey was conducted with two cohorts (2013 and 2015) of internationally educated physical therapists and clinical instructors who were asked about the nature of interaction with CPFs, mentor, and education roles and the benefits and challenges of the role. Thirty-five internationally educated physical therapists and 37 clinical instructors participated and were satisfied with the interaction with CPFs via face-to-face or e-mail communication. There was strong agreement (>80%) that the CPF educator role was to facilitate learner's reflection on clinical practice while the mentor role (>70%) was to answer questions, provide feedback, and investigate clinical concerns and conflicts. There was insufficient time for access to CPFs and resolution of learners' learning needs. There were differences (P = 0.04) in perspective on the benefit of the CPF in assisting with cultural differences. An innovative CPF role provided support encouragement, clinical, and professional advice. There were discordant views regarding the benefits of the CPF role in addressing cultural issues, which requires further examination.

Understanding performance and behavior of tightly coupled outpatient systems using RFID: initial experience.

PubMed

Stahl, James E; Holt, Julie K; Gagliano, Nancy J

2011-06-01

Understanding how clinical systems actually behave in an era of limited medical resources is critical. The purpose of this study was to determine if a radiofrequency-identification-based indoor positioning system (IPS) could objectively and unobtrusively capture outpatient clinic behavior. Primary outcomes were flowtime, wait time and patient/clinician face time. Two contrasting clinics were evaluated: a primary care clinic (PC) with templated scheduling and an urgent care clinic (UC) with unconstrained visit time and first-in, first-out scheduling. All staff wore transponders throughout the study period. Patients carried transponders from check in to check out. All patients and staff were allowed to opt out. The study was approved by hospital IRB. Standard descriptive and analytic statistical methods were used. Five hundred twenty-six patients (309 patients (PC), 217 patients (UC)) and 38 clinicians (eight (PC) and 30 (UC)) volunteered between April 30 and July 1, 2008. Total FT was not significantly different across clinics. PC wait time was significantly shorter (7.6 min [SD 15.8]) vs. UC (19.7 min [SD 25.3], p < 0.0001), and PC Face time was significantly longer (29.9 min, [SD 19.1] vs. UC (9.8 min [SD 8.5], p < 0.0001). PC Face time distributions reflected template scheduling structure. In contrast, face time distributions in UC had a smooth log normal distribution with a lower mean value. Our study seems to indicate that an IPS can successfully measure important clinic process measures in live clinical outpatient settings and capture behavioral differences across different outpatient organizational structures.

Cancer Center Clinic and Research Team Perceptions of Identity and Interactions.

PubMed

Reimer, Torsten; Lee, Simon J Craddock; Garcia, Sandra; Gill, Mary; Duncan, Tobi; Williams, Erin L; Gerber, David E

2017-12-01

Conduct of cancer clinical trials requires coordination and cooperation among research and clinic teams. Diffusion of and confusion about responsibility may occur if team members' perceptions of roles and objectives do not align. These factors are critical to the success of cancer centers but are poorly studied. We developed a survey adapting components of the Adapted Team Climate Inventory, Measure of Team Identification, and Measure of In-Group Bias. Surveys were administered to research and clinic staff at a National Cancer Institute-designated comprehensive cancer center. Data were analyzed using descriptive statistics, t tests, and analyses of variance. Responses were received from 105 staff (clinic, n = 55; research, n = 50; 61% response rate). Compared with clinic staff, research staff identified more strongly with their own group ( P < .01) but less strongly with the overall cancer center ( P = .02). Both clinic staff and research staff viewed their own group's goals as clearer than those of the other group ( P < .01) and felt that members of their groups interacted and shared information within ( P < .01) and across ( P < .01) groups more than the other group did. Research staff perceived daily outcomes as more important than did clinic staff ( P = .05), specifically research-related outcomes ( P = .07). Although there are many similarities between clinic and research teams, we also identified key differences, including perceptions of goal clarity and sharing, understanding and alignment with cancer center goals, and importance of outcomes. Future studies should examine how variation in perceptions and group dynamics between clinic and research teams may impact function and processes of cancer care.

Implications of the behavioral approach to hypnosis.

PubMed

Starker, S

1975-07-01

The findings of behaviorally oriented research regarding the importance of cognitive-motivational variables in hypnosis are examined and some clinical and theoretical implications are explored. Hypnosis seems usefully conceptualized as a complex configuration or gestalt of interacting variables on several different levels, for example, cognitive, motivational, social, physiologic.

Antifungal susceptibilities of Cryptococcus neoformans.

PubMed

Archibald, Lennox K; Tuohy, Marion J; Wilson, Deborah A; Nwanyanwu, Okey; Kazembe, Peter N; Tansuphasawadikul, Somsit; Eampokalap, Boonchuay; Chaovavanich, Achara; Reller, L Barth; Jarvis, William R; Hall, Gerri S; Procop, Gary W

2004-01-01

Susceptibility profiles of medically important fungi in less-developed countries remain uncharacterized. We measured the MICs of amphotericin B, 5-flucytosine, fluconazole, itraconazole, and ketoconazole for Cryptococcus neoformans clinical isolates from Thailand, Malawi, and the United States and found no evidence of resistance or MIC profile differences among the countries.

Unique Medicinal Properties of Withania somnifera: Phytochemical Constituents and Protein Component.

PubMed

Dar, Parvaiz A; Singh, Laishram R; Kamal, Mohammad A; Dar, Tanveer A

2016-01-01

Withania somnifera is an important medicinal herb that has been widely used for the treatment of different clinical conditions. The overall medicinal properties of Withania somnifera make it a viable therapeutic agent for addressing anxiety, cancer, microbial infection, immunomodulation, and neurodegenerative disorders. Biochemical constituents of Withania somnifera like withanolideA, withanolide D, withaferin A and withaniamides play an important role in its pharmacological properties. Proteins like Withania somnifera glycoprotein and withania lectin like-protein possess potent therapeutic properties like antimicrobial, anti-snake venom poison and antimicrobial. In this review, we have tried to present different pharmacological properties associated with different extract preparations, phytochemical constituents and protein component of Withania somnifera. Future insights in this direction have also been highlighted.

Issues and controversies of hepatocellular carcinoma-targeted therapy clinical trials in Asia: experts' opinion.

PubMed

Chen, Pei-Jer; Furuse, Junji; Han, Kwang-Hyub; Hsu, Chiun; Lim, Ho-Yeong; Moon, Hanlim; Qin, Shukui; Ye, Sheng-Long; Yeoh, Ee-Min; Yeo, Winnie

2010-11-01

Asia has a disproportionate share of the world's burden of hepatocellular carcinoma (HCC). However, the highly regarded clinical practice guidelines and recommendations for the design and conduct of clinical trials for HCC largely reflect Western practice. In order to design mutually beneficial international clinical trials of promising targeted therapies, it is imperative to understand how the aetiology, staging and treatment of HCC differ between Asian and Western countries. Our group, comprising experts in oncology and hepatology from countries that constitute the Eastern Asian region, convened to compare and contrast our current practices, evaluate potential compliance with the clinical trial recommendations, and offer suggestions for modifications that would enhance international collaboration. Here, we describe the results of our discussions, including recommendations for appropriate patient stratification based on potentially important differences in HCC aetiology, identification of practices that may confound interpretation of clinical trial outcomes (traditional Chinese medicine; antivirals that target hepatitis B virus; heterogeneous embolization procedures), suggestions for utilizing a common staging system in study protocols, recognition that sorafenib usage is limited by financial constraints and potentially increased toxicity in Asian patients, and expansion of patient populations that should be eligible for initial clinical trials with new agents. © 2010 John Wiley & Sons A/S.

Sex differences in progression to mild cognitive impairment and dementia in Parkinson's disease.

PubMed

Cholerton, Brenna; Johnson, Catherine O; Fish, Brian; Quinn, Joseph F; Chung, Kathryn A; Peterson-Hiller, Amie L; Rosenthal, Liana S; Dawson, Ted M; Albert, Marilyn S; Hu, Shu-Ching; Mata, Ignacio F; Leverenz, James B; Poston, Kathleen L; Montine, Thomas J; Zabetian, Cyrus P; Edwards, Karen L

2018-05-01

Identification of factors associated with progression of cognitive symptoms in Parkinson's disease (PD) is important for treatment planning, clinical care, and design of future clinical trials. The current study sought to identify whether prediction of cognitive progression is aided by examining baseline cognitive features, and whether this differs according to stage of cognitive disease. Participants with PD in the Pacific Udall Center Clinical Consortium who had longitudinal data available and were nondemented at baseline were included in the study (n = 418). Logistic and Cox regression models were utilized to examine the relationship between cognitive, demographic, and clinical variables with risk and time to progression from no cognitive impairment to mild cognitive impairment (PD-MCI) or dementia (PDD), and from PD-MCI to PDD. Processing speed (OR = 1.05, p = 0.009) and working memory (OR = 1.01, p = 0.03) were associated with conversion to PDD among those with PD-MCI at baseline, over and above demographic variables. Conversely, the primary predictive factor in the transition from no cognitive impairment to PD-MCI or PDD was male sex (OR = 4.47, p = 0.004), and males progressed more rapidly than females (p = 0.01). Further, among females with shorter disease duration, progression was slower than for their male counterparts, and poor baseline performance on semantic verbal fluency was associated with shorter time to cognitive impairment in females but not in males. This study provides evidence for sex differences in the progression to cognitive impairment in PD, while specific cognitive features become more important indicators of progression with impending conversion to PDD. Copyright © 2018 Elsevier Ltd. All rights reserved.

Influence of clinical status and parasite load on erythropoiesis and leucopoiesis in dogs naturally infected with leishmania (Leishmania) chagasi.

PubMed

Trópia de Abreu, Raquel; Carvalho, Maria das Graças; Carneiro, Cláudia Martins; Giunchetti, Rodolfo Cordeiro; Teixeira-Carvalho, Andréa; Martins-Filho, Olindo Assis; Coura-Vital, Wendel; Corrêa-Oliveira, Rodrigo; Reis, Alexandre Barbosa

2011-05-10

The bone marrow is considered to be an important storage of parasites in Leishmania-infected dogs, although little is known about cellular genesis in this organ during canine visceral leishmaniasis (CVL). The aim of the present study was to evaluate changes in erythropoiesis and leucopoiesis in bone marrow aspirates from dogs naturally infected with Leishmania chagasi and presenting different clinical statuses and bone marrow parasite densities. The evolution of CVL from asymptomatic to symptomatic status was accompanied by increasing parasite density in the bone marrow. The impact of bone marrow parasite density on cellularity was similar in dogs at different clinical stages, with animals in the high parasite density group. Erythroid and eosinophilic hypoplasia, proliferation of neutrophilic precursor cells and significant increases in lymphocytes and plasma cell numbers were the major alterations observed. Differential bone marrow cell counts revealed increases in the myeloid:erythroid ratio associated to increased numbers of granulopoietic cells in the different clinical groups compared with non-infected dogs. Analysis of the data obtained indicated that the assessment of bone marrow constitutes an additional and useful tool by which to elaborate a prognosis for CVL.

Influence of Clinical Status and Parasite Load on Erythropoiesis and Leucopoiesis in Dogs Naturally Infected with Leishmania (Leishmania) chagasi

PubMed Central

Trópia de Abreu, Raquel; Carvalho, Maria das Graças; Carneiro, Cláudia Martins; Giunchetti, Rodolfo Cordeiro; Teixeira-Carvalho, Andréa; Martins-Filho, Olindo Assis; Coura-Vital, Wendel; Corrêa-Oliveira, Rodrigo; Reis, Alexandre Barbosa

2011-01-01

Background The bone marrow is considered to be an important storage of parasites in Leishmania-infected dogs, although little is known about cellular genesis in this organ during canine visceral leishmaniasis (CVL). Methodology/Principal Findings The aim of the present study was to evaluate changes in erythropoiesis and leucopoiesis in bone marrow aspirates from dogs naturally infected with Leishmania chagasi and presenting different clinical statuses and bone marrow parasite densities. The evolution of CVL from asymptomatic to symptomatic status was accompanied by increasing parasite density in the bone marrow. The impact of bone marrow parasite density on cellularity was similar in dogs at different clinical stages, with animals in the high parasite density group. Erythroid and eosinophilic hypoplasia, proliferation of neutrophilic precursor cells and significant increases in lymphocytes and plasma cell numbers were the major alterations observed. Differential bone marrow cell counts revealed increases in the myeloid:erythroid ratio associated to increased numbers of granulopoietic cells in the different clinical groups compared with non-infected dogs. Conclusions Analysis of the data obtained indicated that the assessment of bone marrow constitutes an additional and useful tool by which to elaborate a prognosis for CVL. PMID:21572995

Coping with persistent pain: a comparison of persistent pain sufferers in a specialty pain clinic and in a family practice clinic.

PubMed

Crook, J; Tunks, E; Kalaher, S; Roberts, J

1988-08-01

Coping has been defined as an effort to manage external and internal demands and conflicts that tax or exceed a person's resources. This paper examines the types of coping strategies used by two groups of persistent pain sufferers: one from a family practice clinic and the other from a specialty pain clinic. The relationship between the use of different types of coping strategies and adjustment was determined. The two study groups of persistent pain sufferers differed significantly from each other on many of the indices developed to tap adjustment but did not differ on any of the Billings and Moos original categories of coping strategies. When a factor analysis of coping items was performed, 5 valid clusters relevant to the chronic pain patient samples were determined. The factor the authors entitled 'adversarialness' with the qualities of dysphoric withdrawal, avoidant behavior and catastrophizing was found to explain adjustment defined by several indices. The authors conclude that it may be important to help persistent pain sufferers to alter their attitudes and behavior that tend toward catastrophizing, avoidance and withdrawal, rather than simply concentrate on trying to teach them techniques for 'coping with stress.'

Quality improvement in New Zealand healthcare. Part 3: achieving effective care through clinical audit.

PubMed

Seddon, Mary; Buchanan, John

2006-08-04

In this third article in the Series on quality improvement, we examine the effectiveness of dimension of healthcare quality. To satisfy this dimension, two equally important facets must be attended to. First the best available evidence must be sought through research, and second that evidence must be applied--this second function is the domain of quality improvement activities generally and clinical audit in particular. Clinical audit is one of the main tools to establish whether the best evidence is being used in practice, as it compares actual practice to a standard of practice. Clinical audit identifies any gaps between what is done and what should be done, and rectifies any deficiencies in the actual processes of care. In this article, the steps involved in a clinical audit, how it is different to research, and the question of whether clinical audit requires ethical approval are explored.

Clinical applications of decellularized extracellular matrices for tissue engineering and regenerative medicine.

PubMed

Parmaksiz, Mahmut; Dogan, Arin; Odabas, Sedat; Elçin, A Eser; Elçin, Y Murat

2016-03-17

Decellularization is the process of removing the cellular components from tissues or organs. It is a promising technology for obtaining a biomaterial with a highly preserved extracellular matrix (ECM), which may also act as a biological scaffold for tissue engineering and regenerative therapies. Decellularized products are gaining clinical importance and market space due to their ease of standardized production, constant availability for grafting and mechanical or biochemical superiority against competing clinical options, yielding clinical results ahead of the ones with autografts in some applications. Current drawbacks and limitations of traditional treatments and clinical applications can be overcome by using decellularized or acellular matrices. Several companies are leading the market with versatile acellular products designed for diverse use in the reconstruction of tissues and organs. This review describes ECM-based decellularized and acellular products that are currently in use for different branches of clinic.

SWI or T2*: which MRI sequence to use in the detection of cerebral microbleeds? The Karolinska Imaging Dementia Study.

PubMed

Shams, S; Martola, J; Cavallin, L; Granberg, T; Shams, M; Aspelin, P; Wahlund, L O; Kristoffersen-Wiberg, M

2015-06-01

Cerebral microbleeds are thought to have potentially important clinical implications in dementia and stroke. However, the use of both T2* and SWI MR imaging sequences for microbleed detection has complicated the cross-comparison of study results. We aimed to determine the impact of microbleed sequences on microbleed detection and associated clinical parameters. Patients from our memory clinic (n = 246; 53% female; mean age, 62) prospectively underwent 3T MR imaging, with conventional thick-section T2*, thick-section SWI, and conventional thin-section SWI. Microbleeds were assessed separately on thick-section SWI, thin-section SWI, and T2* by 3 raters, with varying neuroradiologic experience. Clinical and radiologic parameters from the dementia investigation were analyzed in association with the number of microbleeds in negative binomial regression analyses. Prevalence and number of microbleeds were higher on thick-/thin-section SWI (20/21%) compared with T2*(17%). There was no difference in microbleed prevalence/number between thick- and thin-section SWI. Interrater agreement was excellent for all raters and sequences. Univariate comparisons of clinical parameters between patients with and without microbleeds yielded no difference across sequences. In the regression analysis, only minor differences in clinical associations with the number of microbleeds were noted across sequences. Due to the increased detection of microbleeds, we recommend SWI as the sequence of choice in microbleed detection. Microbleeds and their association with clinical parameters are robust to the effects of varying MR imaging sequences, suggesting that comparison of results across studies is possible, despite differing microbleed sequences. © 2015 by American Journal of Neuroradiology.

How Do Physical Therapists in the United Kingdom Manage Patients With Hip Osteoarthritis? Results of a Cross-Sectional Survey.

PubMed

Holden, Melanie A; Bennell, Kim L; Whittle, Rebecca; Chesterton, Linda; Foster, Nadine E; Halliday, Nicola A; Spiers, Libby N; Mason, Elizabeth M; Quicke, Jonathan G; Mallen, Christian D

2018-06-01

Hip osteoarthritis (OA) is common, painful, and disabling. Physical therapists have an important role in managing patients with hip OA; however, little is known about their current management approach and whether it aligns with clinical guideline recommendations. The objective of this study is to describe United Kingdom (UK) physical therapists' current management of patients with hip OA and to determine whether it aligns with clinical guidelines. The design is a cross-section questionnaire. A questionnaire was mailed to 3126 physical therapists in the UK that explored physical therapists' self-reported management of a patient with hip OA using a case vignette and clinical management questions. The response rate was 52.7% (n = 1646). In total, 1148 (69.7%) physical therapists had treated a patient with hip OA in the last 6 months and were included in the analyses. A treatment package was commonly provided incorporating advice, exercise (strength training 95.9%; general physical activity 85.4%), and other nonpharmacological modalities, predominantly manual therapy (69.6%), and gait retraining (66.4%). There were some differences in reported management between physical therapists based in the National Health Service (NHS) and non-NHS-based physical therapists, including fewer treatment sessions being provided by NHS-based therapists. Limitations include the potential for nonresponder bias and, in clinical practice, physical therapists may manage patients with hip OA differently. UK-based physical therapists commonly provide a package of care for patients with hip OA that is broadly in line with current clinical guidelines, including advice, exercise, and other nonpharmacological treatments. There were some differences in clinical practice between NHS and non-NHS-based physical therapists, but whether these differences impact on clinical outcomes remains unknown.

Analysis of internet use behaviors among clinical medical students in China

PubMed Central

2014-01-01

Background The availability of internet-based information resources is increasing and the appropriate use of such resources is an important subject for clinical medical students. The aims of this study were to investigate the behaviors of clinical medical students regarding the use of internet-based activities, to analyze the behavior and characteristics of the students’ information demands, and to discuss the behaviors and time preferences related to internet use of students with different levels of education. Methods Librarians obtained real-time feedback from 999 clinical medical students to record online activities. The data was recorded in a standard form and then analyzed statistically. Results There were significant differences in the use of the internet for learning activities among the different groups of clinical medical students (P < 0.0001). Learning accounted for 73.5% of all internet use for doctoral candidates, 47.6% of internet use for master’s candidates, 28.7% of internet use for seven-year undergraduate students, and 14.1% of use for five-year undergraduate students. There was also a significant difference in the proportions of leisure and e-commerce activities among the student groups (P < 0.0001), with five-year students displaying the highest total proportion of these activities (59.4% and 18.8%). Internet use for entertainment activities was the same for all groups of clinical medical students. Time of day of internet use was consistent across all student groups, but internet use differed by day of the week (P < 0.01). There was no difference among the time of day of internet use for learning, leisure and entertainment activities during a single day (P > 0.05), but e-commerce activities varied according to time of day (P < 0.05). Learning and e-commerce activities by clinical medical students did not vary by day of the week (P > 0.05), but the distributions of leisure and entertainment activities were different according to day of the week (P < 0.05). Conclusions A stronger demand for learning is associated with a higher academic level of clinical medical students. Differences exist among student groups regarding internet use behaviors and internet use during different time periods. PMID:24690437

Further consideration of the clonal nature of Salmonella typhi: evaluation of molecular and clinical characteristics of strains from Indonesia and Peru.

PubMed Central

Franco, A; Gonzalez, C; Levine, O S; Lagos, R; Hall, R H; Hoffman, S L; Moechtar, M A; Gotuzzo, E; Levine, M M; Hone, D M

1992-01-01

We examined envelope protein profiles, chromosomal restriction endonuclease digest patterns, and immune responses to envelope proteins for collections of Salmonella typhi strains isolated in Peru and Indonesia. Only minor differences in envelope protein patterns were apparent among strains. Strains from 7 of 20 Indonesian patients had a distinct chromosomal digest pattern compared with patterns of Peruvian and other Indonesian strains. Strains with this pattern carried the gene for the j flagellar antigen (H1-j); differences in response to envelope proteins of j and d strains were noted on immunoblot analysis. Our data suggest that there are genotypic and phenotypic differences among S. typhi strains. The clinical importance of these differences remains to be fully evaluated; however, in this study it was not possible to show a clear correlation between strain characteristics and disease severity. Images PMID:1500532

Non-anticoagulant effects of low molecular weight heparins in inflammatory disorders: A review.

PubMed

Yan, Yishu; Ji, Yang; Su, Nan; Mei, Xiang; Wang, Yi; Du, Shanshan; Zhu, Wenming; Zhang, Chong; Lu, Yuan; Xing, Xin-Hui

2017-03-15

Low molecular weight heparins (LMWHs) are produced by chemical or enzymatic depolymerization of unfractionated heparin (UFH). Besides their well-known anticoagulant effects, LMWHs have also been reported to exhibit numerous anti-inflammatory properties. Previous studies have, however, shown that different production processes result in unique structural characteristics of LMWHs. The structural variations may help explain the different therapeutic spectrums in disease treatment for non-anticoagulant effects. In the present review, we summarize major advances in understanding and exploiting the anti-inflammatory disorder activities of LMWHs, based on mechanistic studies, preclinical experiments and clinical trials. We highlight differences in these activities of commercially available LMWHs produced using different manufacturing processes. We stress the importance of structure-activity relationship (SAR) studies on the non-anticoagulant effects of LMWHs and discuss strategies for exploring new clinical indications. Copyright © 2016 Elsevier Ltd. All rights reserved.

Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

PubMed

Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

2015-01-01

In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

Individual differences in posttraumatic distress: problems with the DSM-IV model.

PubMed

Bowman, M L

1999-02-01

To evaluate the evidence concerning the role of threatening life events in accounting for clinically significant posttraumatic stress responses. Research was examined to review the epidemiology, evidence of dose-response relations, and individual difference factors in accounting for variations in conditions, including posttraumatic stress disorder, after exposure to threatening events. The evidence is significantly discrepant from the clinical Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) model. Greater distress arises from individual differences than from event characteristics. Important individual differences that interact with threat exposures include trait negative affectivity (neuroticism); beliefs about emotions, the self, the world, and the sources and consequences of danger; and prevent acts, disorders, and intelligence. Reasons for the discrepancies between the evidence and the current model of posttraumatic distress are proposed. In accounting for responses to threatening life events, the relatively minor contribution of event qualities compared with individual differences has significant treatment implications. Treatment approaches assuming that toxic event exposure creates a posttraumatic disorder fail to consider individual differences that could improve treatment efficacy.

Big data in sleep medicine: prospects and pitfalls in phenotyping

PubMed Central

Bianchi, Matt T; Russo, Kathryn; Gabbidon, Harriett; Smith, Tiaundra; Goparaju, Balaji; Westover, M Brandon

2017-01-01

Clinical polysomnography (PSG) databases are a rich resource in the era of “big data” analytics. We explore the uses and potential pitfalls of clinical data mining of PSG using statistical principles and analysis of clinical data from our sleep center. We performed retrospective analysis of self-reported and objective PSG data from adults who underwent overnight PSG (diagnostic tests, n=1835). Self-reported symptoms overlapped markedly between the two most common categories, insomnia and sleep apnea, with the majority reporting symptoms of both disorders. Standard clinical metrics routinely reported on objective data were analyzed for basic properties (missing values, distributions), pairwise correlations, and descriptive phenotyping. Of 41 continuous variables, including clinical and PSG derived, none passed testing for normality. Objective findings of sleep apnea and periodic limb movements were common, with 51% having an apnea–hypopnea index (AHI) >5 per hour and 25% having a leg movement index >15 per hour. Different visualization methods are shown for common variables to explore population distributions. Phenotyping methods based on clinical databases are discussed for sleep architecture, sleep apnea, and insomnia. Inferential pitfalls are discussed using the current dataset and case examples from the literature. The increasing availability of clinical databases for large-scale analytics holds important promise in sleep medicine, especially as it becomes increasingly important to demonstrate the utility of clinical testing methods in management of sleep disorders. Awareness of the strengths, as well as caution regarding the limitations, will maximize the productive use of big data analytics in sleep medicine. PMID:28243157

Exploring the role of negative cognitions in the relationship between ethnicity, sleep and pain in women with temporomandibular joint disorder.

PubMed

Lerman, Sheera F; Campbell, Claudia M; Buenaver, Luis F; Medak, Mary; Phillips, Jane; Polley, Michelle; Smith, Michael T; Haythornthwaite, Jennifer A

2018-06-08

Negative cognitions are central to the perpetuation of chronic pain and sleep disturbances. Patients with temporomandibular joint disorder (TMJD), a chronic pain condition characterized by pain and limitation in the jaw area, have a high comorbidity of sleep disturbances that possibly exacerbate their condition. Ethnic group differences are documented in pain, sleep and coping, yet the mechanisms driving these differences are still unclear, especially in clinical pain populations. 156 women (79% white, 21% African American (AA)) diagnosed with TMJD were recruited as part of a randomized controlled trial evaluating the effectiveness of interventions targeting sleep and pain catastrophizing on pain in TMJD. Analysis of baseline data demonstrated that relative to white participants, AA exhibited higher levels of clinical pain, insomnia severity and pain catastrophizing, yet there was no ethnic group difference in negative sleep-related cognitions. Mediation models revealed pain catastrophizing, but not sleep-related cognitions or insomnia severity, to be a significant single mediator of the relationship between ethnicity and clinical pain. Only the helplessness component of catastrophizing together with insomnia severity sequentially mediated the ethnicity-pain relationship. These findings identify pain catastrophizing as a potentially important link between ethnicity and clinical pain and suggest that interventions targeting pain-related helplessness could improve both sleep and pain especially for AA patients. Pain related helplessness and insomnia severity contribute to ethnic differences found in clinical pain among woman with temporomandibular joint disorder. Findings can potentially inform interventions that target insomnia and catastrophizing to assist in reducing ethnic disparities in clinical pain. Copyright © 2018. Published by Elsevier Inc.